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2026-07-11 医药 AI 高 Beta 与高现金流杠铃配置:10 万美元组合方案

  • 数据时间:行情截至 2026 年 7 月 10 日美股收盘;基金持仓和规模的最新可用日期介于 5 月 31 日至 7 月 10 日
  • 研究对象:美国大型医疗、分散生物科技、AI/计算生物学与 mRNA 平台公司
  • 报告类型:行业专题与条件式配置方案
  • 资金假设:独立新建 100,000 美元医药组合,不读取现有账户、税务成本或汇率敞口
  • 资料来源:基金发行人、公司 IR、SEC、FDA、Jin10、Yahoo Finance 公开图表、13 篇一手材料归档与 9 篇产品管线导读

结论与建议

建议用 72% 防守与现金流核心 + 18% 高 Beta + 10% 现金储备 建立医药杠铃组合。目标仓位为 XLV 44%、XBI 15%、JNJ 10%、GILD 10%、ABBV 8%、MRNA 2%、SDGR 1%、现金或短期国债基金 10%。

这套配置把三种收益来源拆开:XLV 提供大型医疗行业底仓;JNJ、GILD、ABBV 把组合向可验证的自由现金流和股息倾斜;XBI 分散承接临床、融资和并购 Beta;MRNA 与 SDGR 提供小额、可封顶的技术平台期权。RXRX 留在观察名单,现阶段不叠加第三只直接 AI 个股。

组合没有 LLY 直接仓位。按 7 月 9 日 XLV 官方持仓中 LLY 权重 16.41%计算,44%的 XLV 目标仓带来 7.22%的 LLY 间接暴露,约合 7,220 美元;XBI 没有形成可识别的 LLY 权重。LLY 仍是组合第五大单一公司穿透敞口,来源完全是 XLV。

直接 AI/平台个股合计只配 3%。过去约一年,MRNA、SDGR、RXRX 的日线年化波动率分别约 69.0%、52.6%、69.9%,同期最大回撤约 -35.5%、-51.9%、-58.2%。高 Beta 有真实价格弹性,也有单一临床结果、融资和估值压缩风险。XBI 的 157 只修正等权生物科技持仓能用 0.35% 费率承接更分散的主题暴露。

当前不宜一次买满。XLV、XBI、JNJ、ABBV 均接近近期阻力区,XBI 的 12 日 RSI 约 71.6;7 月 15 日至 8 月 5 日又密集覆盖 JNJ 财报、ABBV/MRNA 财报和 Moderna 流感疫苗 FDA 目标日期。建议首轮投入 36,000 美元,第二轮在 8 月 5 日后按基本面确认投入最多 25,000 美元,剩余 29,000 美元等待回撤或下一次经营确认;10,000 美元储备全程保留。

十万美元目标配置

标的目标比例目标金额组合角色仓位边界
XLV44.0%$44,000大型医疗核心,低费率、高流动性与直接个股穿透合并后,单一公司不超过组合 15%
XBI15.0%$15,000分散的小中盘生物科技高 Beta高 Beta 主体;不同时叠加 IBB
JNJ10.0%$10,000业务分散和股息稳定锚财报或 talc 风险恶化时停止加仓
GILD10.0%$10,000高 FCF yield 与 HIV 长专利期等待并购后净债务进入正式报表
ABBV8.0%$8,000免疫增长、现金流和股息高杠杆与 Apogee 交易限制权重
MRNA2.0%$2,000mRNA 平台与后期临床事件 Beta直接仓硬上限 2%;FDA 决定前不买满
SDGR1.0%$1,000已产生软件收入的计算药物平台直接仓硬上限 1.5%
现金/3 个月 T-Bill/货币基金10.0%$10,000事件缓冲与后续再平衡弹药在 8 月事件窗口结束前维持至少 10%
合计100.0%$100,000

显性 ETF 管理费约为每年 87.70 美元:XLV 44,000 美元按 0.08% 计算为 35.20 美元,XBI 15,000 美元按 0.35% 计算为 52.50 美元。该数字不含交易点差、税、现金工具费用和个股交易成本。

配置穿透:避免把同一家公司买三遍

XLV 已持有 JNJ、ABBV、GILD、MRK、AMGN 和 MRNA。直接增加 JNJ、GILD、ABBV 是主动现金流倾斜,必须按 ETF 穿透后总权重管理。XBI 则把 MRNA、RXRX 等生物科技公司分散到更大的股票池。

公司ETF 间接权重估算直接权重组合穿透权重估算解释
JNJ4.68%10.00%14.68%接近 15% 单一公司上限,不再另行加码
ABBV约 3.46%8.00%约 11.46%含 XLV 7.53%和 XBI 0.99%的基金内权重
GILD约 1.40%10.00%约 11.40%高 FCF 倾斜,同时控制 HIV 单一领域集中
LLY7.22%0%7.22%通过 XLV 持有,避免在高估值区再设直接仓
MRK2.32%0%2.32%保留行业暴露,限制 KEYTRUDA 专利悬崖的直接风险
AMGN1.47%0%1.47%保留分散产品线,避免叠加高净债务
MRNA约 0.43%2.00%约 2.43%XLV 与 XBI 均有小额持仓;直接仓负责事件弹性
RXRX约 0.11%0%约 0.11%只通过 XBI 观察,等待更强临床和商业证据
SDGR0%1.00%1.00%候选 ETF 几乎没有有效暴露,需要单独小仓

估算使用 7 月 9 日 XLV/XBI 官方持仓;基金权重会随价格和再平衡变化。JNJ 已逼近单一公司上限,后续上涨导致穿透权重超过 15%时,优先停止直接加仓,再在季度再平衡时减回目标。

LLY 直接与间接暴露

  • 直接持仓:0%,0 美元。
  • XLV 间接持仓:44% × 16.41% = 7.2204%,按 100,000 美元目标组合约为 7,220.40 美元
  • XBI 间接持仓:当前官方重点持仓中没有可识别的 LLY 权重,本报告按 0%计入穿透估算。
  • 合计穿透:约 7.22%。若 XLV 内 LLY 权重或组合 XLV 权重变化,应在月度穿透复核时重算。

ETF 选择:一个核心、一个高 Beta 卫星

ETF定位费率规模前十大集中度本组合处理
XLVS&P 500 医疗,市值加权0.08%$41.65B61.33%核心 44%;规模、点差和现金流质量最合适
VHT美国全市值医疗0.09%ETF 份额约 $17.8B约 51.8%可替代 XLV,不与 XLV 同时重仓
FHLC美国全市值医疗0.084%$3.22B52.39%与 VHT 高度近似,适合税损替换或 Fidelity 账户
RSPHS&P 500 医疗等权0.40%$0.73B19.34%仅在主动压低 LLY 集中时替代部分 XLV
XBI修正等权生物科技0.35%$11.10B13.02%高 Beta 15%;分散度和非重复性最好
IBB偏成熟大盘生物科技0.44%$9.60B44.10%不选;GILD、AMGN、VRTX 等与大型核心重叠更多
IXJ全球医疗,约 71% 美国0.40%$4.08B47.34%有明确全球化需求时替代 XLV,不作叠加仓

来源:XLVXBIVHTFHLCRSPHIBBIXJ。规模和持仓日期介于 2026 年 5 月 31 日至 7 月 10 日。

VHT 与 FHLC 的 0.006 个百分点费率差,对 100,000 美元全年只有约 6 美元。决定因素应是账户环境、流动性和税损替换需求。RSPH 与 XLV 使用同一 S&P 500 医疗股票池,只改变权重方法。IXJ 提供瑞士、英国、日本和丹麦等市场,但美国仍占约七成。把这些基金同时加入会提高持仓数量和费用,未必增加有效风险因子。

高现金流核心:JNJ、GILD、ABBV

公司2026Q1 收入Q1 OCF / FCFFY2025 FCF / 当前 FCF yield股息率采用理由主要限制
JNJ$24.06B$2.51B / $1.47B约 $19.7B / 3.1%2.09%制药与 MedTech 双支柱;连续 64 年提高股息约 22.2x 2026 调整 EPS,估值不低;talc 风险仍在
GILD$6.96B$2.54B / $2.43B$9.46B / 5.8%2.53%候选中 FCF yield 最高;Biktarvy 和解后最早仿制日延至 2036-04-01HIV 占产品收入 72.4%;Q2 并购后净债务待确认
ABBV$15.00B$3.83B / $3.56B$17.8B / 4.0%2.79%Skyrizi 与 Rinvoq 支撑增长,两者美国物质专利均到 2033 年Q1 净债务约 $63.5B;$10.9B Apogee 现金交易增加杠杆
AMGN$8.62B$2.19B / $1.48B$8.1B / 4.1%2.77%产品线分散Q1 FCF 对股息覆盖约 1.06 倍,净债务约为 FY2025 FCF 的 5.6 倍
MRK$16.29B$3.92B / $2.93B约 $12.4B / 4.1%2.75%当前现金流与估值仍有吸引力KEYTRUDA/QLEX 占 Q1 收入 49.3%,2028-2029 年进入 biosimilar/定价压力窗口

财务来源:强生 Q1 2026 SEC 季报吉利德 Q1 2026 SEC 季报艾伯维 Q1 2026 更新默沙东 Q1 2026 SEC 季报安进 Q1 2026 业绩。FCF 为经营现金流减资本开支;当前 yield 使用 7 月 10 日价格/市值做近似,近期并购后的实际净债务需要下一期报表确认。

直接核心排序为 JNJ > GILD > ABBV。JNJ 的价值来自业务分散与股息稳定,GILD 提供最高 FCF yield,ABBV 提供较强免疫增长但承担更高杠杆。AMGN 与 MRK 仍由 XLV 间接持有,等待股息覆盖、净债务和专利替代路径改善后再评估直接仓。

AI 与计算生物学:先区分技术证据和收入证据

公司可验证的技术/平台证据2026Q1 财务当前估值近似组合处理
MRNAScientific Intelligence Engine 把 AI/ML、自动化和机器人用于发现、制造和临床;mRNA-1010 已进入 FDA 决策窗口收入 $389M;净亏损 $1.34B;现金及投资 $7.46BEV/2025 销售约 10.6x2% 上限;按后期临床和平台事件股管理
SDGR2025 软件收入 $199.5M;Q1 software ACV 同比增 12%至 $28.4M收入 $58.6M;净亏损 $60.0M;现金及证券 $406.4M扣现金后 EV/2025 销售约 3.2x1% 起始;AI 商业收入证据最清晰
RXRXRecursion OS 支撑靶点发现和重新定位;REC-4881 有开放标签 Phase 1b/2 信号收入 $6.47M;净亏损 $117.5M;现金 $665.2MEV/2025 销售约 16.5x只经 XBI 持有;等待随机临床和融资证据

来源:莫德纳 Q1 2026 SEC 季报莫德纳 2026 Science DayFDA MFLUSIVA 审议安排与材料施罗丁格 Q1 2026 业绩Recursion Q1 2026 业绩

MRNA 的主要估值变量仍是疫苗商业化、FDA 审批、肿瘤 Phase 3 和现金消耗。AI 是研发与制造能力的一部分,公司没有披露独立 AI 收入。6 月 18 日 VRBPAC 已举行流感疫苗审议;本次归档的 FDA 官方页面确认会议安排与公开材料,但没有提供投票结果,因此原报告中的“两个年龄组均 9-0”不再作为已核实事实。正式目标日期仍为 8 月 5 日,审议、最终批准、销量和准入属于不同证据层级。个体化癌症疫苗的五年随访可在页内阅读:intismeran autogene 联合 KEYTRUDA 五年数据

SDGR 已把计算平台转化为约 2 亿美元年度软件收入/ACV,但 Q1 软件收入同比下降 21%,公司称主因是 hosted 模式的收入确认变化。Bunsen agentic AI co-scientist 仍处于计划中的 early access 阶段,定价和客户采用尚未披露。

RXRX 的 AI 叙事弹性最高,当前临床证据也最早。REC-4881 的公开结果来自 12 名可评估患者的开放标签研究,原分子 TAK-733 来自 Takeda,Recursion 的平台贡献主要是发现 FAP/APC-loss 应用机制和重新定位。Q1 加权平均股数由上年同期 4.03 亿增至 5.29 亿,稀释风险已经出现在财务数据中。

主要公司背景、盈利能力与管线

本任务共归档 13 篇一手材料:9 篇主要公司画像底稿,以及 4 篇覆盖莫德纳季报、Science Day、FDA 审议安排和 intismeran 五年随访的补充材料。在此基础上新增 9 篇产品与管线导读,把药物机制、目标疾病、首次上市或当前研发阶段、下一项监管/临床节点集中到站内阅读。点击表格中的“经营摘要”或“产品管线”可直接打开对应内容。

文章与快讯归档摘要

公司与组合穿透公司背景盈利能力基线主要产品与管线站内阅读证据口径
LLY:0%直接,约7.22%间接以糖尿病和肥胖为增长主轴,同时覆盖肿瘤、神经与免疫Q1收入$19.80B,净利润$7.40B,OCF约$5.33B,FCF约$3.01BMounjaro、Zepbound、Foundayo、retatrutide;Verzenio、Jaypirca、Kisunla、Ebglyss、Omvoh经营摘要 · 产品管线公司IR与FDA一手材料
JNJ:10%直接,约4.68%间接,合计约14.68%创新制药与 MedTech 双支柱,收入来源在大型药企中较分散Q1收入$24.06B,净利润$5.24B,FCF约$1.47BDARZALEX、CARVYKTI、TREMFYA、SPRAVATO、CAPLYTA;Abiomed、Shockwave经营摘要 · 产品管线SEC、FDA与公司一手材料
GILD:10%直接,约1.40%间接,合计约11.40%HIV 是现金流底盘,肿瘤、肝病和细胞治疗提供第二增长曲线Q1收入$6.96B,净利润$2.02B,FCF约$2.43BBiktarvy、Descovy、Yeztugo、Trodelvy、Livdelzi;细胞治疗与周服HIV方案经营摘要 · 产品管线SEC、FDA与公司一手材料
ABBV:8%直接,约3.46%间接,合计约11.46%免疫、神经、肿瘤和医美四条业务线,Humira 已进入快速衰减期Q1收入$15.00B,调整后EPS $2.65,FCF约$3.56BSkyrizi、Rinvoq、Botox、Vraylar、Venclexta;斑秃、Crohn皮下诱导和神经毒素新资产经营摘要 · 产品管线公司IR与FDA一手材料
MRK:0%直接,约2.32%间接肿瘤、疫苗、心肺和动物保健组合,Keytruda仍决定利润中枢Q1收入$16.29B;因Cidara在研研发费用录得净亏损$4.24B,FCF约$2.93BKeytruda/Qlex、Winrevair、Welireg、Gardasil;MK-1406、TERN-701经营摘要 · 产品管线SEC、FDA与公司一手材料
AMGN:0%直接,约1.47%间接大型生物制药公司,增长产品组合对冲 Prolia、Enbrel 等成熟产品下滑Q1收入$8.62B,GAAP EPS $3.34,FCF约$1.48BRepatha、UPLIZNA、IMDELLTRA;MariTide肥胖与心代谢三期项目经营摘要 · 产品管线公司IR、FDA与欧盟监管材料
MRNA:2%直接,约0.43%间接,合计约2.43%mRNA 平台覆盖呼吸道疫苗、个体化肿瘤和罕见病研发Q1收入$389M,净亏损$1.34B,现金及投资$7.46BSpikevax、mNEXSPIKE、mRESVIA、mCOMBRIAX;mRNA-1010、intismeran经营摘要 · 产品管线SEC、FDA与公司管线页
SDGR:1%直接,ETF间接可忽略计算化学软件与药物发现并行,软件商业化证据强于临床商业化Q1收入$58.6M,净亏损$60.0M,现金及证券$406.4MSGR-1505、SGR-3515;Novartis与BMS合作、Ajax股权经营摘要 · 产品管线SEC与公司临床更新
RXRX:0%直接,约0.11%间接AI原生药物发现平台,当前价值主要来自早期临床与合作期权Q1收入$6.47M,净亏损$117.5M,现金$665.2MREC-1245、REC-4881、REC-4539;注册路径和小样本临床仍待验证经营摘要 · 产品管线SEC与公司临床更新

莫德纳与监管补充阅读:莫德纳一季度收入回升与和解成本莫德纳三层管线布局莫德纳流感疫苗审议安排个体化癌症疫苗五年随访

本地文章库(全部归档请求)

本次共请求 13 篇一手材料,13 篇均已取得完整原文并生成中文摘要。JNJ、GILD、MRK、SDGR 的公司新闻页或 IR 页面曾返回拒绝访问,最终以对应公司 SEC HTML 季报补齐;GILD 使用 SEC 的纯文档输出模式取得正文。原始失败没有被写成可用文章。Jin10 快讯来自独立的事实快照,不计入 13 篇文章,但同样以页内弹窗提供原文事实、时间和限制。

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礼来产品与管线导读

代谢疾病是收入主轴

Mounjaro 与 Zepbound 的活性成分均为 tirzepatide(替尔泊肽),通过同时激活 GIP 与 GLP-1 受体改善血糖、食欲和能量摄入。Mounjaro 于 2022 年 5 月首次获 FDA 批准,用于成人 2 型糖尿病;Zepbound 于 2023 年 11 月获批用于成人肥胖或伴体重相关疾病的超重人群。两者分属糖尿病与体重管理标签,商业上共享同一分子和产能体系。

Foundayo(orforglipron)是口服小分子 GLP-1 受体部分激动剂,2026 年 4 月获 FDA 批准用于长期体重管理。它不需要注射,也没有空腹和饮水限制,目标是把 GLP-1 疗法扩展到不愿或不便注射的人群。Retatrutide 同时作用于 GIP、GLP-1 与胰高血糖素受体,仍处三期临床;公司在 2026 年披露了 2 型糖尿病三期进展,尚未上市。

肿瘤、免疫和神经产品

  • Verzenio(abemaciclib)是 CDK4/6 抑制剂,2017 年首次获批,主要用于 HR阳性/HER2阴性乳腺癌;它代表礼来成熟的肿瘤现金流。
  • Jaypirca(pirtobrutinib)是非共价 BTK 抑制剂,覆盖既往治疗后的套细胞淋巴瘤及慢性淋巴细胞白血病/小淋巴细胞淋巴瘤;2026 年仍在推进联合方案与更前线治疗。
  • Kisunla(donanemab)是针对淀粉样蛋白斑块的抗体,2024 年获批用于早期有症状阿尔茨海默病,疗效判断必须同时看影像学异常等安全风险和输注管理。
  • Ebglyss(lebrikizumab)阻断 IL-13,用于中重度特应性皮炎;Omvoh(mirikizumab)阻断 IL-23p19,用于炎症性肠病。两者承担免疫业务扩张。

时间轴与观察点

  • 已商业化:Mounjaro(2022)、Zepbound(2023)、Kisunla(2024)、Foundayo(2026)。
  • 三期研发:retatrutide;需继续验证减重、血糖、心血管结局、安全性和产能。
  • 经营观察:代谢产品销量与实现价格、医保覆盖、口服与注射产品的互补或内部替代。

主要依据:FDA Mounjaro 首次批准资料FDA Zepbound 批准公告FDA Foundayo 批准公告与礼来 2026Q1 披露。

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强生产品与管线导读

肿瘤:抗体与细胞治疗并行

DARZALEX(daratumumab)是靶向 CD38 的单克隆抗体,2015 年首次获批,用于多发性骨髓瘤;CARVYKTI(ciltacabtagene autoleucel)是患者自体 T 细胞改造的 BCMA CAR-T 疗法,2022 年首次获批,2024 年扩展到至少接受过一线治疗且来那度胺难治的复发/难治骨髓瘤。前者是可重复给药的抗体平台,后者是一次性、制造和医院资源要求更高的个体化细胞治疗。

免疫与神经科学

  • TREMFYA(guselkumab)阻断 IL-23p19,2017 年从斑块型银屑病起步,后续扩展到银屑病关节炎和炎症性肠病。它正在接替受生物类似药冲击的 STELARA。
  • SPRAVATO(esketamine)是鼻喷 NMDA 受体拮抗剂,2019 年获批用于难治性抑郁症,需在认证医疗场所给药并监测镇静、解离和血压。
  • CAPLYTA(lumateperone)调节 5-HT2A、D2 等神经递质通路,用于精神分裂症和双相抑郁等适应症。强生于 2025 年收购 Intra-Cellular Therapies 后取得该产品,因此增长伴随较高并购成本。

医疗科技不是药物管线

Abiomed 的 Impella 是经导管心脏泵,Shockwave 提供血管内碎石技术。它们属于医疗器械,收入驱动来自手术量、医院采用、耗材和临床证据,不能与药品处方量使用同一估值逻辑。

观察点

  • CARVYKTI 的产能、治疗中心覆盖与安全标签变化。
  • TREMFYA 能否填补 STELARA 专利到期后的收入与利润缺口。
  • SPRAVATO、CAPLYTA 增长能否覆盖商业投入和收购摊销。

主要依据:FDA CARVYKTI 批准历史与强生 2026Q1 SEC 季报。

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吉利德产品与管线导读

HIV:治疗、暴露前预防与长效化

Biktarvy 是 bictegravir、emtricitabine 与 tenofovir alafenamide 的每日单片复方,用于 HIV-1 治疗,2018 年首次在美国获批。Descovy 是 emtricitabine/tenofovir alafenamide 双药骨架,可用于 HIV 治疗组合,也用于部分人群的暴露前预防(PrEP)。两者都依赖长期依从性和支付覆盖。

Yeztugo(lenacapavir)靶向 HIV 衣壳,2025 年获批为每半年一次的 PrEP 方案,把预防从每日服药改成一年两次给药。2026 年 6 月,FDA 接受每周口服 Yeztugo 的补充申请,目标审评日期为 2027 年 2 月 2 日。半年注射与周服口服服务于不同依从性和医疗接触偏好。

肿瘤与肝病

  • Trodelvy(sacituzumab govitecan)是 Trop-2 抗体偶联药物,把抗体靶向与细胞毒载荷结合;2020 年从后线转移性三阴性乳腺癌起步,2026 年 6 月扩展到一线不可切除局晚期或转移性三阴性乳腺癌。
  • Livdelzi(seladelpar)是 PPAR-δ 激动剂,2024 年加速获批用于对熊去氧胆酸反应不足或不耐受的原发性胆汁性胆管炎患者,仍需关注确认性证据和肝病市场渗透。
  • Yescarta 与 Tecartus 属于自体 CAR-T 细胞治疗,面向部分淋巴瘤和白血病;制造周期、治疗中心容量及安全管理限制其放量速度。

观察点

  • Yeztugo 的 PrEP 启动、复诊依从性与支付覆盖。
  • Trodelvy 一线适应症能否转化为持续处方增长。
  • Biktarvy 医保价格谈判与公共项目准入变化。

主要依据:Biktarvy 首次批准公告Yeztugo 周服申请Trodelvy 一线批准

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艾伯维产品与管线导读

免疫:Humira 之后的双核心

Skyrizi(risankizumab)是选择性 IL-23p19 抗体,2019 年从斑块型银屑病起步,2022 年进入克罗恩病,随后扩展至溃疡性结肠炎等适应症。Rinvoq(upadacitinib)是口服 JAK1 抑制剂,2019 年从类风湿关节炎起步,后续覆盖特应性皮炎、溃疡性结肠炎和克罗恩病等免疫疾病。Skyrizi 的靶点更集中,Rinvoq 的口服便利性更强,但 JAK 类药物需要更严格的感染、心血管、肿瘤和血栓风险管理。

2026 年研发重点包括 Skyrizi 克罗恩病皮下诱导方案,以及 Rinvoq 的重度斑秃、白癜风等新适应症。前者主要改善给药路径,后者扩大皮肤免疫市场;申请和正面数据并不等同于最终批准。

神经、医美与肿瘤

  • Botox 是肉毒毒素平台,治疗用途覆盖慢性偏头痛、痉挛等,医美用途覆盖动态皱纹。治疗和医美的支付、渠道与周期性不同。
  • Vraylar(cariprazine)是多巴胺 D3/D2 部分激动剂,2015 年首次获批,现用于精神分裂症、双相障碍及重度抑郁症辅助治疗。
  • Venclexta(venetoclax)抑制 BCL-2,2016 年从慢性淋巴细胞白血病起步,并进入急性髓系白血病;2026 年 FDA 又批准其与 acalabrutinib 组成初治 CLL 的固定疗程全口服方案。

观察点

  • Skyrizi 与 Rinvoq 的适应症扩张能否继续超过 Humira 下滑。
  • Venclexta 新联合方案的疗程、竞争和真实世界采用。
  • 神经毒素新资产的生产工艺回复及上市时间。

主要依据:Skyrizi 皮下诱导申请Venclexta 新联合方案与艾伯维 2026Q1 披露。

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默沙东产品与管线导读

Keytruda 平台与皮下化

Keytruda(pembrolizumab)是阻断 PD-1 的免疫检查点抗体,2014 年从晚期黑色素瘤加速批准起步,此后扩展到肺癌、头颈癌、肾癌、妇科肿瘤等多个癌种和辅助治疗阶段。Keytruda Qlex 将 pembrolizumab 与透明质酸酶组合,2025 年获批为皮下注射制剂,目标是缩短给药时间并延续原有适应症平台。

心肺、肾癌和疫苗

  • Winrevair(sotatercept)调节 activin 信号,2024 年获批用于肺动脉高压,以改善运动能力、功能状态并减少临床恶化;它针对血管重塑,与传统扩血管药机制不同。
  • Welireg(belzutifan)抑制 HIF-2α,2021 年首先用于 VHL 病相关肿瘤,后续进入晚期及辅助肾细胞癌。2026 年 Keytruda/Keytruda Qlex 联合 Welireg 获批用于部分术后高复发风险透明细胞肾癌。
  • Gardasil/Gardasil 9 是预防 HPV 相关疾病的疫苗,收入取决于接种覆盖、年龄段扩展和中国等海外库存/需求,而非肿瘤处方逻辑。

并购进入的后期资产

  • MK-1406 来自 Cidara,2026Q1 处于三期 ANCHOR 研究;它是一项长效流感预防候选资产,尚无产品收入。
  • TERN-701 是口服变构 BCR::ABL1 抑制剂,用于既往 TKI 治疗后的慢性期慢性髓性白血病,2026 年处于一期/二期 CARDINAL 研究并取得突破性疗法认定。

观察点

  • Keytruda/Qlex 的转换速度、专利周期与新联合方案。
  • Winrevair、Welireg 能否形成 Keytruda 之外的独立增长支柱。
  • MK-1406 与 TERN-701 的临床结果能否覆盖高额并购研发费用。

主要依据:FDA Winrevair 资料Keytruda/Welireg 2026 批准TERN-701 项目说明

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安进产品与管线导读

成熟增长产品

  • Repatha(evolocumab)是 PCSK9 单克隆抗体,2015 年首次获批,通过提高肝脏清除 LDL 胆固醇的能力用于高胆固醇及心血管风险管理。竞争焦点是更早期人群、支付覆盖和注射依从性。
  • UPLIZNA(inebilizumab)是清除 CD19 阳性 B 细胞的抗体,2020 年首先用于 AQP4 抗体阳性的视神经脊髓炎谱系病;之后扩展到 IgG4 相关疾病和广泛型重症肌无力等自身免疫领域。
  • IMDELLTRA(tarlatamab)是 DLL3×CD3 双特异性 T 细胞连接器,2024 年在美国加速获批用于铂类治疗后进展的广泛期小细胞肺癌。它把患者 T 细胞导向肿瘤,但需管理细胞因子释放综合征和神经毒性。

MariTide 的代谢病逻辑

MariTide(maridebart cafraglutide)是抗体-肽偶联分子,同时阻断 GIP 受体并激活 GLP-1 受体,目标是以较低给药频率治疗肥胖、2 型糖尿病及相关心代谢疾病。安进于 2025 年启动三期开发,2026 年已推进减重维持、转换和糖尿病研究。它仍是临床资产,不能按上市药收入估值。

观察点

  • MariTide 三期减重、停药后维持、耐受性和给药频率优势。
  • IMDELLTRA 从加速批准向更广治疗线和更多地区扩展。
  • UPLIZNA 新适应症能否建立罕见自身免疫病组合。

主要依据:FDA Repatha 适应症资料MariTide 三期进度与安进 2026Q1 披露。

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莫德纳产品与管线导读

已商业化的呼吸道疫苗

  • Spikevax 与 mNEXSPIKE 均为 COVID-19 mRNA 疫苗;后者是下一代较低剂量方案。mRESVIA 是 RSV 疫苗,2024 年首次获批。mCOMBRIAX 是流感/COVID 联合疫苗,截至 2026 年 5 月公司管线页已列为商业化产品。
  • 这些产品共享脂质纳米颗粒递送和 mRNA 制造平台,但季节性、公共采购、推荐人群和竞争会造成收入大幅波动。

近期监管和临床节点

  • mRNA-1010 是季节性流感疫苗,三期研究面向 50 岁以上成人。FDA 在 2026 年 2 月接受修订后的申请,目标审评日期为 8 月 5 日;报告日仍未批准。
  • Intismeran autogene(mRNA-4157/V940)是按患者肿瘤突变定制的个体化新抗原疗法,与 Keytruda 联合用于高风险黑色素瘤。二期五年随访提供长期信号,三期辅助治疗结果仍是决定能否上市的关键证据。
  • 罕见病方向利用 mRNA 在体内表达缺失蛋白;丙酸血症项目预计在 2026 年出现关键数据。早期肿瘤项目还包括 mRNA-4359 等癌症抗原疗法。

平台价值怎么判断

成熟疫苗回答“平台能否生产和销售”,intismeran 与罕见病项目回答“平台能否进入治疗性药物”。后两类资产仍需逐项目验证疗效、安全性、制造和商业可及性,不能用 COVID 疫苗成功直接外推。

主要依据:Moderna 2026 管线页mRNA-1010 审评时间表Moderna 2026 Science Day

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施罗丁格产品与管线导读

先区分软件产品和临床药物

Schrödinger 的成熟产品是用于分子建模、药物设计和材料科学的软件与企业平台;自研药物尚未上市。软件收入、合作里程碑和临床资产使用不同的商业化路径,不能把软件客户采用直接等同于临床成功。

两项核心临床资产

  • SGR-1505 是 MALT1 抑制剂,面向复发/难治 B 细胞恶性肿瘤,包括慢性淋巴细胞白血病和华氏巨球蛋白血症。项目处于一期剂量递增;2025 年 6 月获 FDA 快速通道认定,用于既往至少两线治疗且包含 BTK 抑制剂失败的成人华氏巨球蛋白血症。
  • SGR-3515 同时抑制 Wee1 与 Myt1,目标是破坏肿瘤细胞的 DNA 损伤检查点,用于晚期实体瘤。2026 年披露的一期初步数据仍属于小样本、剂量探索阶段,尚未证明注册性疗效。

研发时间轴和资金边界

公司计划完成 SGR-1505 与 SGR-3515 的一期数据包,并寻找合作伙伴承担中后期开发;除完成当前一期研究外,不计划独立启动更多临床试验。这意味着下一阶段价值取决于合作条款、对方开发承诺和后续试验,而非单靠内部现金推进。

观察点

  • 一期完整数据的缓解持续时间、剂量和安全性。
  • 合作伙伴是否愿意承担二期/三期开发及里程碑付款。
  • 软件 ACV、托管模式转换和药物发现合作是否恢复增长。

主要依据:2026 战略与管线更新2026Q1 临床更新与 SEC 季报。

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Recursion 产品与管线导读

当前没有上市药物

Recursion 的收入主要来自合作,而非处方药销售。它用自动化实验、表型数据和机器学习寻找靶点与分子,但每项临床资产仍要独立通过剂量、安全性、疗效和监管验证。平台缩短候选物发现时间,不会取消临床失败风险。

三项核心临床资产

  • REC-1245 是 RBM39 蛋白降解剂,用于复制压力和 DNA 修复异常相关实体瘤,处于一期/二期 DAHLIA 研究。2026Q1 披露的 16 名可评患者尚未出现剂量限制性毒性,剂量递增仍在进行;补充一期数据预计 2026 年下半年。
  • REC-4881 是变构 MEK1/2 抑制剂,用于家族性腺瘤性息肉病。二期开放标签数据出现息肉负担下降信号,公司已与 FDA 沟通潜在注册研究,监管设计更新预计在 2026 年下半年,更多数据预计 2027 年上半年。
  • REC-4539 是可逆、可进入中枢的 LSD1 抑制剂,用于实体瘤和血液肿瘤。2026 年 4 月完成一期 ENLYGHT 研究首例给药;早期安全性与药代数据预计 2027 年下半年。

如何读早期数据

REC-1245 的无剂量限制性毒性主要回答早期安全和剂量问题;REC-4881 的小样本息肉负担变化还需要注册性设计、对照、持续时间与临床结局;REC-4539 只有首例给药,尚无人体疗效证据。三者不能按上市概率简单相加。

观察点

  • REC-4881 的 FDA 注册路径和研究设计。
  • REC-1245 推荐二期剂量及初步疗效。
  • 2026 年运营现金消耗能否维持低于 3.90 亿美元,现金跑道是否仍到 2028 年初。

主要依据:Recursion 2026Q1 临床与财务更新及同日 8-K 附件。

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礼来上调全年业绩指引

重要性3/5 中

一手财务与产品数据直接覆盖LLY,事实密度高;但为04/30发布的一季度材料,当前日报时效性有限。

中文摘要

核心结论

礼来(Eli Lilly,纽约证券交易所代码:LLY)04/30公布2026年第一季度收入198亿美元、同比增长56%,并将全年收入指引上调至820亿至850亿美元。增长由替尔扎肽糖尿病药Mounjaro和减重药Zepbound的销量拉动,但两者实现价格下降,价格与报销环境仍是业绩持续性的约束。

重要性评级

评级:3/5(中)

这是LLY的公司一手业绩材料,财务、产品和监管信息密度高,且与标的直接相关;但发布日期为04/30,距离07/11日报已有时滞,适合作为业绩与产品线背景,不足以单独代表当前状态。

关键事实

  • 2026年第一季度全球收入为198亿美元,较2025年同期的127亿美元增长56%;销量贡献增长65%,实现价格下降拖累13个百分点。
  • 报告口径每股收益为8.26美元,同比增长170%;非美国通用会计准则(Non-GAAP,剔除特定项目的调整后口径)每股收益为8.55美元,同比增长156%。
  • 公司将2026年全年收入指引由800亿至830亿美元上调至820亿至850亿美元,非美国通用会计准则每股收益指引由33.50至35.00美元上调至35.50至37.00美元。
  • Mounjaro季度收入87亿美元,同比增长125%;其中美国收入42亿美元,同比增长59%,美国以外收入44亿美元,2025年同期为12亿美元。
  • Zepbound美国季度收入41亿美元,同比增长79%;公司称需求强劲,但此前公布的现金支付价格下调及返点、折扣影响实现价格。
  • 美国以外收入增长81%至77亿美元;Mounjaro纳入中国国家医保药品目录(NRDL,国家基本医疗保险报销目录)带来销量增长,同时压低实现价格。
  • 美国食品药品监督管理局(FDA)已批准口服减重药Foundayo(orforglipron);公司还披露该药、retatrutide等项目的三期临床进展,并宣布拟收购Orna Therapeutics、Centessa Pharmaceuticals、Kelonia Therapeutics和Ajax Therapeutics。
  • 研发费用同比增长28%至35亿美元,销售、一般及管理费用同比增长19%至29亿美元;第一季度还确认5.84亿美元收购研发费用及2.79亿美元诉讼相关等特殊费用。

作者观点与证据

文章是礼来自行发布的业绩新闻稿,立场强调新药动能、监管进展和业务拓展。收入、每股收益、产品销售额和指引均有财务表格支持;增长前景、临床价值和收购协同仍属于公司前瞻性陈述。公司也列示定价、报销、竞争、供应链、监管、诉讼和研发失败等风险,前瞻指引未提供与美国通用会计准则的完整可比调节。

与相关标的的关系

  • LLY:Mounjaro与Zepbound合计构成季度收入增长的主要来源,全年指引上调直接更新公司收入与盈利目标。
  • LLY:实现价格下降、中国医保准入后的海外价格影响,以及对少数产品和产品类别的依赖,是判断业绩质量和增长延续性时需并列查看的事实。

时效性与限制

文章发布于04/30(未给出具体时刻),为公司一手披露,适合引用其截至03/31的财务与产品事实。材料在07/11已超过两个月,且仅反映管理层披露,未包含后续季度销售、竞争产品、处方数据或独立分析师验证。

后续跟踪

  • Mounjaro和Zepbound的季度销量、实现价格、返点和折扣变化。
  • Foundayo上市后的可及性、处方需求与监管进展。
  • 中国医保目录带来的海外销量增量与价格影响。
  • 820亿至850亿美元全年收入指引及35.50至37.00美元每股收益指引的后续兑现情况。
原文
Lilly reports first-quarter 2026 financial results, raises full year guidance, and highlights momentum of new medicines

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News Release

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Lilly reports first-quarter 2026 financial results, raises full year guidance, and highlights momentum of new medicines

April 30, 2026

PDF Version

  • Revenue in Q1 2026 increased 56% to $19.8 billion primarily driven by volume growth, partially offset by lower realized prices from Mounjaro and Zepbound.
  • Q1 2026 EPS increased by 170% to $8.26 on a reported basis and increased by 156% to $8.55 on a non-GAAP basis. The Q1 2026 reported and non-GAAP EPS included $0.52 of acquired IPR&D charges compared to $1.72 in Q1 2025.
  • Increased 2026 full-year revenue guidance to be in the range of $82.0 billion to $85.0 billion and non-GAAP EPS guidance to be in the range of $35.50 to $37.00 .
  • Regulatory progress included U.S. FDA approval of Foundayo (orforglipron) for adults with obesity, or overweight with weight-related medical problems.
  • Pipeline progress included positive Phase 3 results from Foundayo (orforglipron) in adults with type 2 diabetes and obesity or overweight at increased cardiovascular risk, Jaypirca in combination with venetoclax and rituximab in relapsed or refractory CLL or SLL, Taltz and Zepbound used together for adults with psoriasis and obesity or overweight, and retatrutide in type 2 diabetes.
  • Business development activity included the agreements to acquire Orna Therapeutics, Centessa Pharmaceuticals plc ., Kelonia Therapeutics, and Ajax Therapeutics.
  • Company announces planned Investment Community Meeting for December 7, 2026

INDIANAPOLIS , April 30, 2026 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced its financial results for the first quarter of 2026 and provided updated 2026 financial guidance.

"2026 is off to a strong start, we delivered 56% revenue growth in the first quarter and raised our full-year revenue guidance by $2 billion ," said David A. Ricks , Lilly chair and CEO. "A key milestone was the U.S. FDA approval of Foundayo—the only approved GLP-1 pill that can be taken any time of day, without food and water restrictions. Foundayo will meaningfully expand the number of people who can benefit from GLP-1s. We also delivered pipeline progress across all four therapeutic areas and continued investing in Lilly's future growth through four acquisitions."

Financial Results

$ in millions, except

per share data

First-Quarter

2026

2025

% Change

Revenue

$   19,799

$   12,729

56 %

Net income – Reported

7,396

2,759

168 %

Earnings per share – Reported

8.26

3.06

170 %

Net income – Non-GAAP

7,663

3,004

155 %

Earnings per share – Non-GAAP

8.55

3.34

156 %

A discussion of the non-GAAP financial measures is included below under "Reconciliation of GAAP Reported to Selected Non-GAAP Adjusted Information (Unaudited)."

First-Quarter Reported Results

In Q1 2026, worldwide revenue was $19.8 billion , an increase of 56% compared with Q1 2025, driven by a 65% increase in volume, partially offset by a 13% decrease due to lower realized prices. Key Products 1  revenue grew to $13.4 billion in Q1 2026, led by Mounjaro and Zepbound. Key Products revenue in the Immunology, Oncology, and Neuroscience therapeutic areas grew 160% in Q1 2026 compared to Q1 2025.

Revenue in the U.S. increased 43% to $12.1 billion , driven by a 49% increase in volume, partially offset by a 7% decrease due to lower realized prices. The increase in U.S. volume was driven by Zepbound and Mounjaro and the decline in realized prices was primarily driven by Zepbound and Taltz.

Revenue outside the U.S. increased 81% to $7.7 billion , driven by a 95% increase in volume, partially offset by a 25% decrease due to lower realized prices. The lower realized prices outside the U.S. were driven primarily by the addition of Mounjaro to the National Reimbursed Drug List (NRDL) in China . The volume increase outside the U.S. was driven by Mounjaro. Jardiance revenue outside the U.S. included one-time benefits of $250 million in Q1 2026 compared to $370 million in Q1 2025, associated with the company's collaboration with Boehringer Ingelheim .

1  The Company currently defines Key Products as Ebglyss, Inluriyo, Jaypirca, Kisunla, Mounjaro, Omvoh, and Zepbound. Effective Q1 2026, Verzenio is excluded from Key Products.

Gross margin increased 54% to $16.2 billion in Q1 2026. Gross margin as a percent of revenue was 81.9%, a decrease of 0.6 percentage points versus the same quarter last year. The change was primarily driven by lower realized prices.

In Q1 2026, research and development expenses increased 28% to $3.5 billion , or 18% of revenue, driven by continued investments in the company's early and late-stage portfolio.

Marketing, selling, and administrative expenses increased 19% to $2.9 billion in Q1 2026, primarily driven by promotional efforts supporting ongoing and planned launches.

In Q1 2026, the company recognized acquired in-process research and development (IPR&D) charges of $584 million compared with $1.6 billion in Q1 2025. The Q1 2025 charges primarily related to the acquisition of Scorpion Therapeutics, Inc.'s PI3Kα inhibitor program STX-478.

Asset impairment, restructuring and other special charges of $279 million in Q1 2026 were primarily related to litigation matters. In Q1 2025, there was a charge of $35 million related to intangible asset impairments.

The effective tax rate was 16.4% in Q1 2026 compared with 20.2% in Q1 2025, primarily driven by the unfavorable tax impact of a non-deductible acquired IPR&D charge in Q1 2025. The 2026 and 2025 effective tax rates were impacted by net discrete tax benefits in each period.

In Q1 2026, net income and earnings per share (EPS) were $7 .4 billion and $8.26 , respectively, compared with net income of $2 .8 billion and EPS of $3.06 in Q1 2025. EPS in Q1 2026 and Q1 2025 included acquired IPR&D charges of $0.52 and $1.72 , respectively.

First-Quarter Non-GAAP Measures

On a non-GAAP basis, Q1 2026 gross margin increased 54% to $16.4 billion . Gross margin as a percent of revenue was 82.6%, a decrease of 0.9 percentage points versus the same quarter last year. The change was primarily driven by lower realized prices.

The non-GAAP effective tax rate was 16.5% in Q1 2026 compared with 20.2% in Q1 2025, primarily driven by the unfavorable tax impact of a non-deductible acquired IPR&D charge in Q1 2025. The 2026 and 2025 effective tax rates were impacted by net discrete tax benefits in each period.

On a non-GAAP basis, Q1 2026 net income and EPS were $7.7 billion and $8.55 , respectively, compared with net income of $3 .0 billion and EPS of $3.34 in Q1 2025. Non-GAAP EPS in Q1 2026 and Q1 2025 included acquired IPR&D charges of $0.52 and $1.72 , respectively.

For further detail on non-GAAP measures, see the reconciliation below as well as the "Reconciliation of GAAP Reported to Selected Non-GAAP Adjusted Information (Unaudited)" table later in this press release.

First-Quarter

2026

2025

% Change

Earnings per share (reported)

$       8.26

$       3.06

170 %

Amortization of intangible assets

.11

.11

Asset impairment, restructuring and other special charges

.25

.03

Net losses (gains) on investments in equity securities

(.07)

.13

Earnings per share (non-GAAP)

$       8.55

$       3.34

156 %

Acquired IPR&D

.52

1.72

(70) %

Numbers may not add due to rounding

Selected Revenue Highlights

(Dollars in millions)

First-Quarter

Selected Products

2026

2025

% Change

Mounjaro

$       8,662

$       3,842

125 %

Zepbound (1)

4,160

2,312

80 %

Jaypirca

165

92

79 %

Ebglyss

145

60

141 %

Kisunla

124

22

NM

Omvoh

80

37

115 %

Inluriyo

35

NM

Total Revenue

19,799

12,729

56 %

(1) Tirzepatide is marketed for obesity under the brand name Zepbound in Canada , Japan , and the

United States .

NM - not meaningful

Mounjaro

For Q1 2026, worldwide Mounjaro revenue increased 125% to $8.7 billion . U.S. revenue was $4.2 billion , an increase of 59%, reflecting strong demand, partially offset by lower realized prices. Lower realized prices were partially offset by a favorable one-time adjustment to estimates for rebates and discounts in Q1 2026. Revenue outside the U.S. increased to $4.4 billion compared with $1.2 billion in Q1 2025, primarily driven by volume growth, partially offset by lower realized prices driven by the addition of Mounjaro to the NRDL within the China market.

Zepbound

For Q1 2026, U.S. Zepbound revenue increased 79% to $4.1 billion , compared with $2.3 billion in Q1 2025, primarily driven by strong demand, partially offset by lower realized prices, including previously announced reductions in cash pay prices. Lower realized prices were partially offset by a favorable one-time adjustment to estimates for rebates and discounts in Q1 2026.

Lilly shared numerous updates recently on key regulatory, clinical, business development and other events, including:

Regulatory

FDA approves Lilly's Foundayo™ (orforglipron), the only GLP-1 pill for weight loss that can be taken any time of day without food or water restrictions ( announcement )

Lilly's Olumiant (baricitinib) recommended by CHMP for approval of expanded use in the European Union for adolescents with severe alopecia areata ( announcement )

Zepbound (tirzepatide), the most prescribed weight management medication in 2025, now available in multi-dose KwikPen ( announcement )

Clinical

ACHIEVE-4, the longest Phase 3 study of Lilly's Foundayo (orforglipron) to date, reaffirmed its cardiovascular and overall safety profile as well as consistent improvements across key measures of cardiometabolic health ( announcement )

Lilly's Jaypirca (pirtobrutinib) significantly extended progression-free survival when added to a venetoclax time-limited regimen in patients with previously treated CLL/SLL ( announcement )

Phase 3b data presented at AAD Annual Meeting show Lilly's Taltz (ixekizumab) plus Zepbound (tirzepatide) delivered superior efficacy for adults with psoriatic arthritis and obesity ( announcement )

Lilly's EBGLYSS (lebrikizumab-lbkz) delivered up to four years of durable disease control for patients with moderate-to-severe atopic dermatitis ( announcement )

Lilly's triple agonist, retatrutide, demonstrated significant reductions in A1C and weight in first Phase 3 trial for treatment of type 2 diabetes ( announcement )

Lilly's EBGLYSS (lebrikizumab-lbkz) is the first and only selective IL-13 inhibitor to deliver positive Phase 3 outcomes in patients aged six months to 18 years with moderate-to-severe atopic dermatitis ( announcement )

Lilly's oral GLP-1, orforglipron, delivered superior blood sugar control and weight loss compared to oral semaglutide in head-to-head type 2 diabetes trial published in The Lancet ( announcement )

Patients with Crohn's disease maintained steroid-free remission for three years with Lilly's Omvoh (mirikizumab-mrkz) ( announcement )

Lilly's Taltz (ixekizumab) and Zepbound (tirzepatide) used together delivered superior efficacy in first-of-its-kind Phase 3b trial for adults with psoriasis and obesity or overweight ( announcement )

Lilly's Retevmo (selpercatinib) delivers substantial event-free survival benefit as an adjuvant therapy in early-stage RET fusion-positive lung cancer ( announcement )

Other

Lilly to acquire Ajax Therapeutics to advance outcomes for patients with myelofibrosis and polycythemia vera ( announcement )

Lilly to acquire Kelonia Therapeutics to advance in vivo CAR-T cell therapies ( announcement )

Foundayo™ (orforglipron), Lilly's new oral GLP-1 pill for weight loss, now available in the U.S. ( announcement )

Lilly to acquire Centessa Pharmaceuticals to advance treatments for sleep-wake disorders ( announcement )

Lilly Employer Connect platform launches with over fifteen independent program administrators offering tailored obesity coverage options to expand access to patients ( announcement )

Lilly to acquire Orna Therapeutics to advance cell therapies ( announcement )

For information on important public announcements, visit the news section of Lilly's website.

2026 Financial Guidance

In addition to providing guidance for GAAP revenue, Lilly provides guidance for certain non-GAAP measures.

The following table summarizes the company's updated full-year 2026 non-GAAP financial guidance, reflecting the strong revenue performance in Q1:

Prior

Updated

Revenue

$80 to $83 billion

$82 to $85 billion

Performance Margin (1)(2)

46.0% to 47.5%

47.0% to 48.5%

Tax Rate (1)(3)

18% to 19%

Unchanged

Earnings per Share (1)(3)(4)

$33.50 to $35.00

$35.50 to $37.00

(1) Lilly does not provide reconciliations of forward-looking non-GAAP measures to the most directly comparable GAAP measures

because comparable GAAP measures are not reasonably accessible or reliable due to the inherent difficulty in forecasting and

quantifying measures that would be necessary for a reconciliation. In particular, Lilly cannot reasonably predict certain items including

net gains and losses on equity securities, asset impairment, acquisition or divestiture-related items, restructuring and other adjustments,

without unreasonable effort. These items are uncertain, depend on various factors, and could have a material impact on Lilly's reported

results in accordance with GAAP. See Reconciliation of GAAP Reported to Selected Non-GAAP Adjusted Information (Unaudited) table

below for additional Non-GAAP information.

(2) The company defines performance margin as gross margin less research and development and marketing, selling, and administrative

expenses divided by revenue.

(3) Guidance does not include acquired in-process research and development (IPR&D) incurred after March 31, 2026 .

(4) 2026 assumes shares outstanding of approximately 895 million and foreign currency exchange rate assumptions of 1.16 (Euro) , 153

(Yen) and 7.1 (Yuan)

Webcast of Conference Call

As previously announced, investors and the general public can access a live webcast of the Q1 2026 financial results conference call through a link on Lilly's website at investor.lilly.com/webcasts-and-presentations . The conference call will begin at 10 a.m. Eastern time today and will be available for replay via the website.

Non-GAAP Financial Measures

Certain financial information is presented on both a reported and a non-GAAP basis. Some numbers in this press release may not add due to rounding. Reported results were prepared in accordance with U.S. generally accepted accounting principles (GAAP) and include all revenue and expenses recognized during the periods. Historical non-GAAP measures reflect adjustments for the items described in the reconciliation tables later in the release. Related materials provide certain GAAP and non-GAAP figures excluding the impact of foreign exchange rates. Lilly recalculates current period figures on a constant currency basis by keeping constant the exchange rates from the base period. The company's 2026 financial guidance (other than revenue) is provided on a non-GAAP basis, as described in "2026 Financial Guidance" above. Non-GAAP measures are presented to provide additional insights into the underlying trends in the company's business.

About Lilly

Lilly is a medicine company turning science into healing to make life better for people around the world. We've been pioneering life-changing discoveries for nearly 150 years, and today our medicines help tens of millions of people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit Lilly.com and Lilly.com/news . F-LLY

Cautionary Statement Regarding Forward-Looking Statements

This press release and the related attachments contain management's intentions and expectations for the future, all of which are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. The words "estimate", "project", "intend", "expect", "believe", "target", "plan", "anticipate", "may", "could", "aim", "seek", "will", "continue", and similar expressions are intended to identify forward-looking statements. Actual results may differ materially due to various factors. The following include some but not all of the factors that could cause actual results or events to differ from those anticipated, including the significant costs and uncertainties in the pharmaceutical research and development process, including with respect to the timing and process of obtaining regulatory approvals and the ability of the company's clinical trials to meet expectations; the impact and uncertain outcome of acquisitions and business development transactions and related costs; intense competition affecting the company's products, pipeline, or industry; market uptake of launched products and indications; continued pricing pressures and the impact of actions of governmental and private actors affecting pricing of, reimbursement for, and patient access to pharmaceuticals, or reporting obligations related thereto; the implementation of our voluntary agreement with the U.S. government related to drug pricing and access; Developments or uncertainties related to our or competitive products, including as may relate to safety or efficacy concerns; dependence on relatively few products or product classes for a significant percentage of the company's total revenue and a consolidated supply chain; the expiration of intellectual property protection for certain of the company's products and competition from generic and biosimilar products; the company's ability to protect and enforce patents and other intellectual property and changes in patent law or regulations related to data package exclusivity; information technology system inadequacies, inadequate controls or procedures, security breaches, or operating failures; unauthorized access, disclosure, misappropriation, or compromise of confidential information or other data stored in the company's information technology systems, networks, and facilities, or those of third parties with whom the company shares its data and violations of data protection laws or regulations; issues with product supply, regulatory approvals, or other negative outcomes stemming from manufacturing difficulties, disruptions, or shortages, including as a result of unpredictability and variability in demand, labor shortages, third-party performance, quality, cyber-attacks, or regulatory actions related to the company's and third-party facilities; reliance on third-party relationships and outsourcing arrangements; the use of artificial intelligence or other emerging technologies in various facets of the company's operations, including partnerships related to the use of, or the sharing of such technologies with third parties, which may exacerbate competitive, regulatory, litigation, cybersecurity, and other risks; the impact of global macroeconomic conditions, including uneven economic growth or downturns or uncertainty, trade and other global disputes and interruptions, including related to tariffs, trade protection measures, and similar restrictions, international tension, conflicts, regional dependencies, or other costs, uncertainties, and risks related to engaging in business globally; fluctuations in foreign currency exchange rates, changes in interest rates and inflation or deflation; significant and sudden declines or volatility in the trading price of the company's common stock and market capitalization; litigation, investigations, or other similar proceedings involving past, current, or future products, activities, or intellectual property; changes in tax law and regulations, tax rates, or events that differ from our assumptions related to tax positions; regulatory changes, developments, and uncertainty; regulatory oversight and actions regarding the company's operations and products; regulatory compliance problems or government investigations; risks from the proliferation of counterfeit, misbranded, adulterated, or illegally compounded products; actual or perceived deviation from environmental-, social-, or governance-related requirements or expectations; asset impairments and restructuring charges; and changes in accounting and reporting standards. For additional information about the factors that could cause actual results or events to differ materially from forward-looking statements, please see the company's latest Form 10-K and subsequent Forms 8-K and 10-Q filed with the Securities and Exchange Commission. You should not place undue reliance on forward-looking statements contained in this press release and the related attachments, which, except as otherwise noted, speak only as of the date of this release. Except as is required by law, the company expressly disclaims any obligation to publicly release any revisions to forward-looking statements contained in this press release and the related attachments to reflect events or circumstances after the date of this release.

Website Information

The information contained on, or that may be accessed through, our website or any third-party website is not incorporated by reference into, and is not a part of, this earnings release.

Trademarks and Trade Names

All trademarks or trade names referred to in this press release are the property of the company, or, to the extent trademarks or trade names belonging to other companies are referenced in this press release, the property of their respective owners. Solely for convenience, the trademarks and trade names in this press release are referred to without the ® and ™ symbols, but such references should not be construed as any indicator that the company or, to the extent applicable, their respective owners will not assert, to the fullest extent under applicable law, the company's or their rights thereto. We do not intend the use or display of other companies' trademarks and trade names to imply a relationship with, or endorsement or sponsorship of us by, any other companies.

Eli Lilly and Company

Operating Results (Unaudited) – REPORTED

(Dollars in millions, except per share data; numbers may not add due to rounding)

Three Months Ended

March 31 ,

2026

2025

% Chg.

Revenue

$

19,799

$

12,729

56 %

Cost of sales

3,577

2,225

61 %

Research and development

3,510

2,734

28 %

Marketing, selling, and administrative

2,934

2,468

19 %

Acquired IPR&D

584

1,572

(63) %

Asset impairment, restructuring and other special charges

279

35

NM

Operating income

8,915

3,695

141 %

Net interest income (expense)

(253)

(195)

Net other income (expense)

188

(44)

Other income (expense)

(65)

(239)

(73) %

Income before income taxes

8,850

3,456

156 %

Income tax expense

1,454

697

109 %

Net income

$

7,396

$

2,759

168 %

Earnings per share - diluted

$

8.26

$

3.06

170 %

Dividends paid per share

$

1.73

$

1.50

15 %

Weighted-average shares outstanding (thousand) - diluted

895,918

900,604

NM – not meaningful

Eli Lilly and Company

Reconciliation of GAAP Reported to Selected Non-GAAP Adjusted Information (Unaudited)

(Dollars in millions, except per share data; numbers may not add due to rounding)

Three Months Ended March 31 ,

2026

2025

Gross Margin - As Reported

$              16,222

$              10,504

Increase for excluded items:

Amortization of intangible assets (Cost of sales) (1)

128

123

Gross Margin - Non-GAAP

$              16,350

$              10,627

Gross Margin as a percent of revenue - As Reported

81.9 %

82.5 %

Gross Margin as a percent of revenue - Non-GAAP (2)

82.6 %

83.5 %

1.   Excludes amortization of intangibles primarily associated with costs of marketed products acquired or licensed from third parties.

2.   Non-GAAP gross margin as a percent of revenue reflects the gross margin effects of the adjustments presented above.

Reconciliation of GAAP Reported to Selected Non-GAAP Adjusted Information (Unaudited)

(Dollars in millions, except per share data; numbers may not add due to rounding)

Three Months Ended March 31 ,

2026

2025

Net income - Reported

$               7,396

$               2,759

Increase (decrease) for excluded items:

Amortization of intangible assets (Cost of sales) (1)

128

123

Asset impairment, restructuring and other special charges (2)

279

35

Net (gains) losses on investments in equity securities (Other income/expense)

(79)

152

Corresponding tax effects (Income taxes)

(61)

(65)

Net income - Non-GAAP

$               7,663

$               3,004

Effective tax rate - Reported

16.4 %

20.2 %

Effective tax rate - Non-GAAP (3)

16.5 %

20.2 %

Earnings per share (diluted) - Reported

$                 8.26

$                 3.06

Earnings per share (diluted) - Non-GAAP

$                 8.55

$                 3.34

1.

Excludes amortization of intangibles primarily associated with costs of marketed products acquired or licensed from third parties.

2.

For the three months ended March 31, 2026 , excluded charges primarily related to litigation matters. For the three months ended March 31, 2025 , excluded charges related to intangible asset impairments.

3.

Non-GAAP tax rate reflects the tax effects of the adjustments presented above.

Refer to:

Ashley Hennessey ; gentry_ashley_jo@lilly.com ; (317) 416-4363 (Media)

Mike Czapar ; czapar_michael_c@lilly.com ; (317) 617-0983 (Investors)

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SOURCE Eli Lilly and Company

打开原文

强生增长与专利悬崖并行

重要性4/5 高

美国证券交易委员会一手季报直接覆盖JNJ核心收入、产品替代、利润率、并购与法律风险,但截至07/11时已非新增披露。

中文摘要

核心结论

强生公司 2026 财年第一季度收入增长扎实:全球销售额为240.62亿美元,同比增9.9%,经营性增长6.4%;创新制药的肿瘤、神经科学和医疗科技业务提供增量。STELARA(乌司奴单抗)受生物类似药竞争影响,销售额同比降59.7%,已拖累全球经营性销售增长约5.4%,产品组合和利润率承压仍是公司当期最明确的缺口。

重要性评级

评级:4/5(高)。这是强生向美国证券交易委员会提交的2026年一季度10-Q文件,覆盖收入、核心产品、并购、诉讼和重组等一手事实;发布日期为04/22,距07/11已有一段时间,适合作为公司基本面底稿而非当日新增事件。

关键事实

  • 截至03/29的2026财年第一季度,全球销售额240.62亿美元,上年同期218.93亿美元;汇率带来3.5个百分点正向影响,收购与剥离净增经营性销售1.1个百分点,主要来自CAPLYTA(鲁美哌隆)。
  • 创新制药销售额154.26亿美元,同比增11.2%,经营性增7.4%;肿瘤销售69.73亿美元,经营性增17.8%,其中DARZALEX(达雷妥尤单抗)销售39.64亿美元、CARVYKTI(西达基奥仑赛)销售5.97亿美元,分别同比增22.5%和62.1%。
  • 免疫业务销售33.80亿美元,经营性降11.8%;STELARA销售6.56亿美元,上年同期16.25亿美元。TREMFYA(古塞奇尤单抗)销售16.08亿美元,同比增68.3%,公司将增长归因于各适应症份额提升、炎症性肠病上市动能和市场扩张。
  • 神经科学业务经营性增29.3%;SPRAVATO(艾司氯胺酮)销售4.68亿美元,同比增46.4%,2025年04/02收购的CAPLYTA当季销售2.70亿美元。公司2025年以145亿美元收购Intra-Cellular Therapies,以30.5亿美元收购Halda Therapeutics,两项合计净收购对价175亿美元。
  • MedTech(医疗科技)销售86.36亿美元,同比增7.7%、经营性增4.6%;Abiomed销售4.88亿美元、Shockwave销售3.05亿美元,经营性增14.4%和18.1%。
  • 净利润52.35亿美元,低于上年同期109.99亿美元;可比期含约70亿美元滑石粉准备金转回,本期含3亿美元滑石粉事项费用,该同比口径受诉讼会计项目显著影响。
  • 创新制药税前利润率从37.6%降至34.5%,医疗科技从17.7%降至14.3%;文件列出的影响包括STELARA下降后的不利产品结构、TREMFYA与CAPLYTA投入、关税、骨科分拆相关成本及2025年剥离收益。
  • 截至03/29,美国仍约有7.5万名原告就含滑石粉身体粉产品提出直接索赔;公司称若干法律事项已计提准备,但超出已计提金额的可能损失范围无法估计。

作者观点与证据

文件没有第三方作者立场,主体为公司法定披露。增长驱动和产品销售归因来自管理层经营分析,收入、利润、分部数据和并购对价可由财务报表核对;专利诉讼、产品竞争、滑石粉事项及关税影响均带有持续不确定性,公司无法量化若干法律事项超出准备金的损失范围。

与相关标的的关系

JNJ(强生公司股票代码)的收入结构同时反映肿瘤与神经科学扩张、STELARA快速流失及医疗科技利润率下行。后续利润和增长质量取决于高增长产品能否填补免疫业务缺口,以及关税、诉讼和重组成本的演变。

时效性与限制

文件发布于04/22(未给出具体时刻),财务观察期截至03/29,属于约一季度后的正式历史披露,未包含07/11后的销售、监管或诉讼进展。原文为公司申报文件,事实密度高,但经营驱动、法律结果与未来竞争影响包含管理层判断;归档文本用于受保护的内部报告阅读。

后续跟踪

  • STELARA全球生物类似药上市节奏,以及TREMFYA在炎症性肠病适应症的销售增量。
  • DARZALEX、CARVYKTI、SPRAVATO和CAPLYTA的持续增长及其对创新制药利润率的影响。
  • 医疗科技关税、手术业务重组及骨科分拆相关成本;手术业务重组预计总成本9亿至10亿美元,并计划在2026财年末前基本完成。
  • 滑石粉诉讼准备金、约7.5万名原告诉讼、专利案件及美国药品价格谈判计划的后续披露。
原文
Johnson & Johnson Quarterly Report for the Fiscal First Quarter Ended March 29, 2026

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

Quarterly Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

for the quarterly period ended March 29, 2026

or

Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

for the transition period from            to

Commission file number 1-3215

Johnson & Johnson

(Exact name of registrant as specified in its charter)

New Jersey

22-1024240

(State or other jurisdiction of

incorporation or organization)

(I.R.S. Employer

Identification No.)

One Johnson & Johnson Plaza

New Brunswick , New Jersey 08933

(Address of principal executive offices)

Registrant’s telephone number, including area code ( 732 )  524-0400

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements                     for the past 90 days. ☑ Yes ☐ No

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). ☑ Yes ☐ No

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer

Accelerated filer

Non-accelerated filer

Smaller reporting company

Emerging growth company

If an emerging growth company, indicated by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). ☐ Yes ☑ No

SECURITIES REGISTERED PURSUANT TO SECTION 12(b) OF THE ACT

Title of each class

Trading Symbol

Name of each exchange on which registered

Common Stock, Par Value $1.00

JNJ

New York Stock Exchange

1.150% Notes Due November 2028

JNJ28

New York Stock Exchange

2.700% Notes Due February 2029

JNJ29B

New York Stock Exchange

3.200% Notes Due June 2032

JNJ32

New York Stock Exchange

3.050% Notes Due February 2033

JNJ33B

New York Stock Exchange

1.650% Notes Due May 2035

JNJ35

New York Stock Exchange

3.350% Notes Due June 2036

JNJ36A

New York Stock Exchange

3.350% Notes Due February 2037

JNJ37B

New York Stock Exchange

3.550% Notes Due June 2044

JNJ44

New York Stock Exchange

3.600% Notes Due February 2045

JNJ45

New York Stock Exchange

3.700% Notes Due February 2055

JNJ55

New York Stock Exchange

Indicate the number of shares outstanding of each of the issuer’s classes of common stock, as of the latest practicable date.

On April 17, 2026, 2,407,216,971 shares of Common Stock, $1.00 par value, were outstanding.

JOHNSON & JOHNSON AND SUBSIDIARIES

Table of contents

Item

Page

Part I

Financial information

1

Item 1

Financial statements (unaudited)

1

Consolidated balance sheets — March 2 9 , 202 6 and December 2 8 , 202 5

1

Consolidated statements of earnings for the fiscal first quarters ended March 2 9 , 202 6 and March 30 , 202 5

2

Consolidated statements of comprehensive income for the fiscal first quarters ended March 2 9 , 202 6 and March   30 , 202 5

3

Consolidated statements of equity for the fiscal first quarters ended March 2 9 , 202 6 and March 30 , 202 5

4

Consolidated statements of cash flows for the fiscal three months ended March 2 9 , 202 6 and March 30 , 202 5

5

Notes to consolidated financial statements

6

Item 2

Management’s discussion and analysis of financial condition and results of operations

27

Item 3

Quantitative and qualitative disclosures about market risk

37

Item 4

Controls and procedures

37

Part II

Other information

38

Item 1

Legal proceedings

38

Item 2

Unregistered sales of equity securities and use of proceeds

38

Item 5

Other information

39

Item 6

Exhibits

39

Signatures

40

Cautionary note regarding forward-looking statements

This Quarterly Report on Form 10-Q and Johnson & Johnson’s other publicly available documents contain “forward-looking statements” within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Management and representatives of Johnson & Johnson and its subsidiaries (the Company) also may from time to time make forward-looking statements. Forward-looking statements do not relate strictly to historical or current facts and reflect management’s assumptions, views, plans, objectives and projections about the future. Forward-looking statements may be identified by the use of words such as “plans,” “expects,” “will,” “anticipates,” “estimates,” and other words of similar meaning in conjunction with, among other things: discussions of future operations, expected operating results, financial performance; impact of planned acquisitions and dispositions; impact and timing of restructuring initiatives including associated cost savings and other benefits; the Company’s strategy for growth; product development activities; regulatory approvals; market position and expenditures.

Because forward-looking statements are based on current beliefs, expectations and assumptions regarding future events, they are subject to uncertainties, risks and changes that are difficult to predict and many of which are outside of the Company’s control. Investors should realize that if underlying assumptions prove inaccurate, or known or unknown risks or uncertainties materialize, the Company’s actual results and financial condition could vary materially from expectations and projections expressed or implied in its forward-looking statements. Investors are therefore cautioned not to rely on these forward-looking statements. Risks and uncertainties include, but are not limited to:

Risks related to product development, market success and competition

• Challenges and uncertainties inherent in innovation and development of new and improved products and technologies on which the Company’s continued growth and success depend, including uncertainty of clinical outcomes, additional analysis of existing clinical data, obtaining regulatory approvals, health plan coverage and customer access, and initial and continued commercial success;

• Challenges to the Company’s ability to secure and maintain adequate patent and other intellectual property rights for new and existing products and technologies in the United States and other important markets;

• The impact of patent expirations, typically followed by the introduction of competing generic, biosimilar or other products and resulting revenue and market share losses;

• Increasingly aggressive and frequent challenges to the Company’s patents by competitors and others seeking to launch competing generic, biosimilar or other products and increased receptivity of courts, the United States Patent and Trademark Office and other decision makers to such challenges, potentially resulting in loss of market exclusivity and rapid decline in sales for the relevant product sooner than expected;

• Competition in research and development of new and improved products, processes and technologies, which can result in product and process obsolescence;

• Competition to reach agreement with third parties for collaboration, licensing, development and marketing agreements for products and technologies;

• Competition based on cost-effectiveness, product performance, technological advances and patents attained by competitors; and

• Allegations that the Company’s products infringe the patents and other intellectual property rights of third parties, which could adversely affect the Company’s ability to sell the products in question and require the payment of money damages and future royalties.

Risks related to product liability, litigation and regulatory activity

• Product efficacy or safety concerns, whether or not based on scientific evidence, potentially resulting in product withdrawals, recalls, regulatory action on the part of the United States Food and Drug Administration (U.S. FDA) (or international counterparts), declining sales, reputational damage, increased litigation expense and share price impact;

• The impact, including declining sales and reputational damage, of significant litigation or government action adverse to the Company, including product liability claims and allegations related to pharmaceutical marketing practices and contracting strategies;

• The impact of an adverse judgment or settlement and the adequacy of reserves related to legal proceedings, including patent litigation, product liability, personal injury claims, securities class actions, government investigations, employment and other legal proceedings;

• Increased scrutiny of the healthcare industry by government agencies and state attorneys general resulting in investigations and prosecutions, which carry the risk of significant civil and criminal penalties, including, but not limited to, debarment from government business;

• Failure to meet compliance obligations in compliance agreements with governments or government agencies, which could result in significant sanctions;

• Potential changes to applicable laws and regulations affecting United States and international operations, including relating to: approval of new products; licensing and patent rights; sales and promotion of healthcare products; access to, and reimbursement and pricing for, healthcare products and services; environmental protection; and sourcing of raw materials;

• Compliance with local regulations and laws that may restrict the Company’s ability to manufacture or sell its products in relevant markets, including requirements to comply with medical device reporting regulations and other requirements such as the European Union’s Medical Devices Regulation;

• Changes in domestic and international tax laws and regulations, increasing audit scrutiny by tax authorities around the world may cause exposures to additional tax liabilities potentially in excess of existing reserves; and

• The issuance of new or revised accounting standards by the Financial Accounting Standards Board and regulations by the Securities and Exchange Commission.

Risks related to the Company’s strategic initiatives, healthcare market trends and the planned separation of the Company's Orthopaedics Business

• Pricing pressures resulting from trends toward healthcare cost containment, including the continued consolidation among healthcare providers and other market participants, trends toward managed care, the shift toward governments increasingly becoming the primary payors of healthcare expenses, significant new entrants to the healthcare markets seeking to reduce costs and government pressure on companies to voluntarily reduce costs and price increases;

• Restricted spending patterns of individual, institutional and governmental purchasers of healthcare products and services due to economic hardship and budgetary constraints;

• Challenges to the Company’s ability to realize its strategy for growth including through externally sourced innovations, such as development collaborations, strategic acquisitions, licensing and marketing agreements, and the potential heightened costs of any such external arrangements due to competitive pressures;

• The potential that the expected strategic benefits and opportunities from any planned or completed acquisition or divestiture by the Company may not be realized or may take longer to realize than expected;

• The potential that the expected benefits and opportunities related to past and ongoing restructuring actions may not be realized or may take longer to realize than expected.

• The Company’s ability to satisfy the necessary conditions to consummate the planned separation of the Company’s Orthopaedics business on a timely basis or at all;

• The Company’s ability to successfully separate the Company’s Orthopaedics business and realize the anticipated benefits from the planned separation; and

• The structure of the separation transaction and the future operating and financial performance, market position and business strategy for each company.

Risks related to economic conditions, financial markets and operating internationally

• The risks associated with global operations on the Company and its customers and suppliers, including foreign governments in countries in which the Company operates;

• The impact of inflation and fluctuations in interest rates and currency exchange rates and the potential effect of such fluctuations on revenues, expenses and resulting margins;

• Potential changes in export/import and trade laws, regulations and policies of the United States and other countries, including any increased trade restrictions or tariffs and potential drug reimportation legislation, and the impact of such changes on raw material prices, supply chains market volatility and the pace of product development;

• The impact on international operations from financial instability in international economies, sovereign risk, possible imposition of governmental controls and restrictive economic policies, and unstable international governments and legal systems;

• The impact of global public health crises and pandemics;

• Changes to global climate, extreme weather and natural disasters that could affect demand for the Company’s products and services, cause disruptions in manufacturing and distribution networks, alter the availability of goods and services within the supply chain, and affect the overall design and integrity of the Company’s products and operations;

• The impact of global or economic changes or events, including global tensions and war; and

• The impact of armed conflicts and terrorist attacks in the United States and other parts of the world, including social and economic disruptions and instability of financial and other markets.

Risks related to supply chain and operations

• Difficulties and delays in manufacturing, internally, through third-party providers or otherwise within the supply chain, that may lead to voluntary or involuntary business interruptions or shutdowns, product shortages, withdrawals or suspensions of products from the market, and potential regulatory action;

• Interruptions and breaches of the Company’s information technology systems or those of the Company’s vendors, which could result in reputational, competitive, operational or other business harm as well as financial costs and regulatory action;

• Reliance on global supply chains and production and distribution processes that are complex and subject to increasing regulatory requirements that may adversely affect supply, sourcing and pricing of materials used in the Company’s products; and

• The potential that the expected benefits and opportunities related to restructuring actions may not be realized or may take longer to realize than expected, including due to any required approvals from applicable regulatory authorities.

Investors also should carefully read the Risk Factors described in Item 1A of the Company's Annual Report on Form 10-K for the fiscal year ended December 28, 2025, for a description of certain risks that could, among other things, cause the Company’s actual results to differ materially from those expressed in its forward-looking statements. Investors should understand that it is not possible to predict or identify all such factors and should not consider the risks described above to be a complete statement of all potential risks and uncertainties. The Company does not undertake to publicly update any forward-looking statement that may be made from time to time, whether as a result of new information or future events or developments.

Table of Contents

Part I — Financial information

Item 1 — Financial statements

Johnson & Johnson and subsidiaries consolidated balance sheets

(Unaudited; Dollars in Millions Except Share and Per Share Data)

March 29, 2026 December 28, 2025

Assets

Current assets:

Cash and cash equivalents (Note 4) $ 21,688 19,709

Marketable securities 363 393

Accounts receivable, trade, less allowances $ 174 (2025, $ 183 )

17,721 17,178

Inventories (Note 2) 14,583 14,191

Prepaid expenses and other

4,818 4,153

Total current assets 59,173 55,624

Property, plant and equipment at cost 54,695 54,364

Less: accumulated depreciation ( 31,425 ) ( 31,195 )

Property, plant and equipment, net 23,270 23,169

Intangible assets, net (Note 3) 49,061 50,403

Goodwill (Note 3) 48,558 48,772

Deferred taxes on income (Note 5) 6,727 6,874

Other assets

14,105 14,368

Total assets $ 200,894 199,210

Liabilities and shareholders’ equity

Current liabilities:

Loans and notes payable $ 17,460 8,495

Accounts payable 10,460 11,991

Accrued liabilities 7,399 8,594

Accrued rebates, returns and promotions 18,399 19,124

Accrued compensation and employee related obligations 2,911 4,534

Accrued taxes on income (Note 5)

1,087 1,388

Total current liabilities 57,716 54,126

Long-term debt (Note 4) 37,527 39,438

Deferred taxes on income (Note 5) 7,011 6,791

Employee related obligations (Note 6) 6,760 6,957

Long-term taxes payable (Note 5) 486 486

Other liabilities

10,208 9,868

Total liabilities $ 119,708 117,666

Commitments and Contingencies (Note 11)

Shareholders’ equity:

Common stock — par value $ 1.00 per share (authorized 4,320,000,000 shares; issued 3,119,843,000 shares)

$ 3,120 3,120

Accumulated other comprehensive income (loss) (Note 7) ( 14,831 ) ( 14,930 )

Retained earnings and Additional paid-in capital 169,161 168,978

Less: common stock held in treasury, at cost ( 713,258,000 and 711,904,000 shares)

76,264 75,624

Total shareholders’ equity $ 81,186 81,544

Total liabilities and shareholders’ equity $ 200,894 199,210

See Notes to Consolidated Financial Statements

Form 10-Q

1

Table of Contents

Johnson & Johnson and subsidiaries consolidated statements of earnings

(Unaudited; Dollars & Shares in Millions Except Per Share Amounts)

Fiscal First Quarter Ended

March 29,

2026 Percent

to Sales March 30,

2025 Percent

to Sales

Sales to customers (Note 9) $ 24,062 100.0 % $ 21,893 100.0 %

Cost of products sold 8,106   33.7   7,357 33.6

Gross profit 15,956   66.3   14,536 66.4

Selling, marketing and administrative expenses 6,034   25.1   5,112 23.3

Research and development expense 3,527   14.7   3,225 14.7

In-process research and development impairments 36   0.1   — —

Interest income ( 229 ) ( 1.0 ) ( 332 ) ( 1.5 )

Interest expense, net of portion capitalized 272   1.2   204 0.9

Other (income) expense, net 294   1.2   ( 7,321 ) ( 33.4 )

Restructuring (Note 12) 32   0.1   17 0.1

Earnings before provision for taxes on income 5,990   24.9   13,631 62.3

Provision for taxes on income (Note 5) 755   3.1   2,632 12.1

Net earnings $ 5,235   21.8   % $ 10,999 50.2   %

Net earnings per share (Note 8)

Basic $ 2.17     $ 4.57

Diluted $ 2.14     $ 4.54

Avg. shares outstanding

Basic 2,408.7     2,407.2

Diluted 2,445.2     2,423.8

See Notes to Consolidated Financial Statements

2

Table of Contents

Johnson & Johnson and subsidiaries consolidated statements of comprehensive income

(Unaudited; Dollars in Millions)

Fiscal First Quarter Ended

March 29, 2026 March 30, 2025

Net earnings $ 5,235 10,999

Other comprehensive income (loss), net of tax

Foreign currency translation 334 ( 575 )

Employee benefit plans:

Prior service cost amortization during period ( 36 ) ( 35 )

Gain (loss) amortization during period 75 77

Net change 39 42

Derivatives & hedges:

Unrealized gain (loss) arising during period ( 77 ) 676

Reclassifications to earnings ( 197 ) ( 142 )

Net change ( 274 ) 534

Other comprehensive income (loss) 99 1

Comprehensive income $ 5,334 11,000

See Notes to Consolidated Financial Statements

The tax cost/(benefit) effects in other comprehensive income/(loss) for the fiscal first quarter were as follows for 2026 and 2025, respectively: Foreign Currency Translation: $( 279 ) million and $ 400 million; Employee Benefit Plans: $ 10 million and $ 11 million; Derivatives & Hedges: $( 73 ) million and $ 142 million.

Form 10-Q

3

Table of Contents

Johnson & Johnson and subsidiaries consolidated statements of equity

(Unaudited; Dollars in Millions)

Fiscal First Quarter Ended March 29, 2026

Total Retained

Earnings and Additional Paid-in Capital

Accumulated

Other

Comprehensive

Income (AOCI) Common Stock

Issued Amount Treasury

Stock

Amount

Balance, December 28, 2025

$ 81,544 168,978 ( 14,930 ) 3,120 ( 75,624 )

Net earnings 5,235 5,235 — — —

Cash dividends paid ($ 1.30 per share)

( 3,131 ) ( 3,131 ) — — —

Employee compensation and stock option plans 1,473 ( 1,921 ) — — 3,394

Repurchase of common stock (including excise tax) ( 4,034 ) — — — ( 4,034 )

Other comprehensive income (loss), net of tax 99 — 99 — —

Balance, March 29, 2026

$ 81,186 169,161 ( 14,831 ) 3,120 ( 76,264 )

Fiscal First Quarter Ended March 30, 2025

Total Retained

Earnings and Additional Paid-in Capital

Accumulated

Other

Comprehensive

Income Common Stock

Issued Amount Treasury

Stock

Amount

Balance, December 29, 2024 $ 71,490 155,791 ( 11,741 ) 3,120 ( 75,680 )

Net earnings 10,999 10,999 — — —

Cash dividends paid ($ 1.24 per share)

( 2,989 ) ( 2,989 ) — — —

Employee compensation and stock option plans 737 ( 1,166 ) — — 1,903

Repurchase of common stock (including excise tax) ( 2,129 ) — — — ( 2,129 )

Other comprehensive income (loss), net of tax 1 — 1 — —

Balance, March 30, 2025 $ 78,109 162,635 ( 11,740 ) 3,120 ( 75,906 )

See Notes to Consolidated Financial Statements

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Johnson & Johnson and subsidiaries consolidated statements of cash flows

(Unaudited; Dollars in Millions)

Fiscal Three Months Ended

March 29,

2026 March 30,

2025

Cash flows from operating activities

Net earnings

$ 5,235 10,999

Adjustments to reconcile net earnings to cash flows from operating activities:

Depreciation and amortization of property and intangibles

2,004 1,772

Stock based compensation

300 288

Asset write-downs

36 30

Charges for acquired in-process research and development assets

2 16

Net loss/(gain) on sale of assets/businesses

12 ( 75 )

Deferred tax provision

159 2,172

Credit losses and accounts receivable allowances

( 8 ) ( 4 )

Changes in assets and liabilities, net of effects from acquisitions and divestitures:

Increase in accounts receivable

( 595 ) ( 926 )

Increase in inventories

( 431 ) ( 146 )

Decrease in accounts payable and accrued liabilities

( 3,920 ) ( 2,126 )

Decrease/(Increase) in other current and non-current assets

349 ( 1,317 )

Decrease in other current and non-current liabilities

( 629 ) ( 6,509 )

Net cash flows from operating activities

2,514   4,174

Cash flows used for investing activities

Additions to property, plant and equipment

( 1,049 ) ( 795 )

Proceeds from the disposal of assets/businesses, net (Note 10)

29 279

Acquired in-process research and development assets / related milestones (Note 10)

— ( 14 )

Purchases of investments

( 144 ) ( 251 )

Sales of investments

209 218

Credit support agreements activity, net

( 31 ) 296

Other (including capitalized licenses and milestones)

( 54 ) ( 30 )

Net cash used for investing activities

( 1,040 ) ( 297 )

Cash flows from financing activities

Dividends to shareholders

( 3,131 ) ( 2,989 )

Repurchase of common stock

( 4,028 ) ( 2,127 )

Proceeds from short-term debt, net

12,439 8,784

Repayment of short-term debt, net

( 3,223 ) ( 2,120 )

Proceeds from long-term debt, net of issuance costs

— 9,138

Repayment of long-term debt

( 2,002 ) ( 751 )

Proceeds from the exercise of stock options/employee withholding tax on stock awards, net

1,172 450

Credit support agreements activity, net

( 109 ) ( 3 )

Other

( 588 ) 40

Net cash from financing activities

530 10,422

Effect of exchange rate changes on cash and cash equivalents ( 25 ) 70

Increase in cash and cash equivalents

1,979 14,369

Cash and cash equivalents, beginning of period 19,709 24,105

Cash and cash equivalents, end of period 21,688 38,474

See Notes to Consolidated Financial Statements

Form 10-Q

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Notes to consolidated financial statements

Note 1 — The accompanying unaudited interim consolidated financial statements and related notes should be read in conjunction with the audited Consolidated Financial Statements of Johnson & Johnson and its subsidiaries (the Company) and related notes as contained in the Company’s Annual Report on Form 10-K for the fiscal year ended December 28, 2025. The unaudited interim financial statements include all adjustments (consisting only of normal recurring adjustments) and accruals necessary in the judgment of management for a fair statement of the results for the periods presented.

Columns and rows within tables may not add due to rounding. Percentages have been calculated using actual, non-rounded figures.

Recently Adopted Accounting Standards

ASU 2025-07: Derivates and Hedging (Topic 815) and Revenue from Contracts with Customers (TOPIC 606)

Effective beginning fiscal year 2026, the Company prospectively adopted the amended guidance issued by the FASB that adds a scope exception to exclude from derivative accounting non-exchange-traded contracts with variables (underlyings) that are based on operations or activities specific to one of the parties to the contract. The adoption of this new accounting standard did not have a material impact on the Company’s consolidated financial statements.

Recently Issued Accounting Standards Not Yet Adopted

There were no new material accounting standards issued in the fiscal first quarter of 2026.

Supplier finance program obligations

The Company has agreements for supplier finance programs with third-party financial institutions. These programs provide enrolled suppliers the ability to finance payment obligations from the Company with the third-party financial institutions. The Company is not a party to the arrangements between the suppliers and the third-party financial institutions. The Company’s obligations to its suppliers, including amounts due, and scheduled payment dates (which have general payment terms of 90 days), are not affected by a participating supplier’s decision to join in the program.

Confirmed obligations under the program as of March 29, 2026, and December 28, 2025, were $ 0.7  billion and $ 0.8  billion, respectively. The obligations are presented as Accounts payable on the Consolidated Balance Sheets.

Note 2 — Inventories

(Dollars in Millions) March 29, 2026 December 28, 2025

Raw materials and supplies $ 2,612 2,530

Goods in process 4,033 3,828

Finished goods 7,938 7,833

Total inventories $ 14,583 14,191

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Note 3 — Intangible assets and goodwill

Intangible assets that have finite useful lives are amortized over their estimated useful lives. The latest annual impairment assessment of goodwill and indefinite lived intangible assets was completed in the fiscal fourth quarter of 2025. Future impairment tests for goodwill and indefinite lived intangible assets will be performed annually in the fiscal fourth quarter, or sooner, if warranted.

(Dollars in Millions) March 29, 2026 December 28, 2025

Intangible assets with definite lives:

Patents and trademarks — gross $ 58,515 59,156

Less accumulated amortization ( 32,939 )

( 32,507 )

Patents and trademarks — net $ 25,576

26,649

Customer relationships and other intangibles — gross 21,340 21,361

Less accumulated amortization ( 15,156 ) ( 14,998 )

Customer relationships and other intangibles — net (1)

$ 6,184

6,363

Intangible assets with indefinite lives:

Trademarks 1,766 1,772

Purchased in-process research and development 15,535 15,619

Total intangible assets — net $ 49,061 50,403

(1) The majority is comprised of customer relationships

Goodwill as of March 29, 2026 was allocated by segment of business as follows:

(Dollars in Millions) Innovative

Medicine

MedTech Total

Goodwill at December 28, 2025

$ 14,967 33,805 48,772

Goodwill, related to acquisitions — — —

Goodwill, related to divestitures — — —

Currency translation/Other ( 155 )

( 59 )

( 214 )

Goodwill at March 29, 2026

$ 14,812 33,746 48,558

The weighted average amortization period for patents and trademarks is approximately 12 years. The weighted average amortization period for customer relationships and other intangible assets is approximately 19 years. The amortization expense of amortizable intangible assets included in the cost of products sold was $ 1.2  billion and $ 1.1 billion for the fiscal first quarters ended March 29, 2026 and March 30, 2025, respectively.

The estimated amortization expense for approved products, before tax, for the five succeeding years is approximately:

(Dollars in Millions)

2026 2027 2028 2029 2030

$ 5,100 4,400 3,700 3,600 3,500

See Note 10 to the Consolidated Financial Statements for additional details related to acquisitions and divestitures.

Form 10-Q

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Note 4 — Fair value measurements

The Company uses forward foreign exchange contracts to manage its exposure to the variability of cash flows, primarily related to the foreign exchange rate changes of future intercompany product and third-party purchases of materials denominated in a foreign currency. The Company uses cross currency interest rate swaps to manage currency risk primarily related to borrowings. Both types of derivatives are designated as cash flow hedges.

Additionally, the Company uses interest rate swaps as an instrument to manage interest rate risk related to fixed rate borrowings. These derivatives are designated as fair value hedges. The Company uses cross currency interest rate swaps and forward foreign exchange contracts designated as net investment hedges. Additionally, the Company uses forward foreign exchange contracts to offset its exposure to certain foreign currency assets and liabilities. These forward foreign exchange contracts are not designated as hedges, and therefore, changes in the fair values of these derivatives are recognized in earnings, thereby offsetting the current earnings effect of the related foreign currency assets and liabilities.

The Company does not enter into derivative financial instruments for trading or speculative purposes, or that contain credit risk related contingent features. The Company maintains credit support agreements (CSA) with certain derivative counterparties establishing collateral thresholds based on respective credit ratings and netting agreements. As of March 29, 2026, the cumulative amount of cash collateral paid by the Company under the CSA amounted to $ 4.7 billion net, related to net investment and cash flow hedges. On an ongoing basis, the Company monitors counter-party credit ratings. The Company considers credit non-performance risk to be low because the Company primarily enters into agreements with commercial institutions that have at least an investment grade credit rating. Refer to the table on significant financial assets and liabilities measured at fair value contained in this footnote for receivables and payables with these commercial institutions. As of March 29, 2026, the Company had notional amounts outstanding for forward foreign exchange contracts, cross currency interest rate swaps and interest rate swaps of $ 43.9  billion, $ 37.9  billion and $ 8.0  billion, respectively. As of December 28, 2025, the Company had notional amounts outstanding for forward foreign exchange contracts, cross currency interest rate swaps and interest rate swaps of $ 40.6 billion, $ 38.9 billion and $ 8.0 billion, respectively.

All derivative instruments are recorded on the balance sheet at fair value. Changes in the fair value of derivatives are recorded each period in current earnings or other comprehensive income, depending on whether the derivative is designated as part of a hedge transaction, and if so, the type of hedge transaction.

The designation as a cash flow hedge is made at the entrance date of the derivative contract. At inception, all derivatives are expected to be highly effective. Foreign exchange contracts designated as cash flow hedges are accounted for under the forward method and all gains/losses associated with these contracts will be recognized in the income statement when the hedged item impacts earnings. Changes in the fair value of these derivatives are recorded in accumulated other comprehensive income until the underlying transaction affects earnings and are then reclassified to earnings in the same account as the hedged transaction.

Gains and losses associated with interest rate swaps and changes in fair value of hedged debt attributable to changes in interest rates are recorded to interest expense in the period in which they occur. Gains and losses on net investment hedges are accounted for through the currency translation account within accumulated other comprehensive income. The portion excluded from effectiveness testing is recorded through interest (income) expense using the spot method. On an ongoing basis, the Company assesses whether each derivative continues to be highly effective in offsetting changes of hedged items. If and when a derivative is no longer expected to be highly effective, hedge accounting is discontinued.

The Company designated its Euro denominated notes with due dates ranging from 2028 to 2055 as a net investment hedge of the Company's investments in certain of its international subsidiaries that use the Euro as their functional currency in order to reduce the volatility caused by changes in exchange rates.

As of March 29, 2026, the balance of deferred net loss on derivatives included in accumulated other comprehensive income was $ 0.6  billion after-tax. For additional information, see the Consolidated Statements of Comprehensive Income and Note 7. The Company expects that substantially all of the amounts related to forward foreign exchange contracts will be reclassified into earnings over the next 12 months as a result of transactions that are expected to occur over that period. The maximum length of time over which the Company is hedging transaction exposure is 18 months, excluding interest rate contracts and net investment hedge contracts. The amount ultimately realized in earnings may differ as foreign exchange rates change. Realized gains and losses are ultimately determined by actual exchange rates at maturity of the derivative.

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The following table is a summary of the activity related to derivatives and hedges for the fiscal first quarters ended March 29, 2026 and March 30, 2025, net of tax:

March 29, 2026 March 30, 2025

(Dollars in Millions) Sales Cost of

Products

Sold

R&D

Expense

Interest

(Income)

Expense

Other

(Income)

Expense

Sales Cost of

Products

Sold

R&D

Expense

Interest

(Income)

Expense

Other

(Income)

Expense

The effects of fair value, net investment and cash flow hedging:

Gain (Loss) on fair value hedging relationship:

Interest rate swaps contracts:

Hedged items $ — — — 36 — — — — 188 —

Derivatives designated as hedging instruments — — — ( 36 ) — — — — ( 188 ) —

Gain (Loss) on net investment hedging relationship:

Cross currency interest rate swaps contracts:

Amount of gain or (loss) recognized in income on derivative amount excluded from effectiveness testing — — — 47 — — — — 49 —

Amount of gain or (loss) recognized in AOCI — — — 47 — — — — 49 —

Gain (Loss) on cash flow hedging relationship:

Forward foreign exchange contracts:

Amount of gain or (loss) reclassified from AOCI into income 1 73 ( 5 ) — ( 2 ) ( 1 ) 10 1 — —

Amount of gain or (loss) recognized in AOCI ( 7 ) ( 195 ) 37 — 25 3 105 ( 36 ) — ( 11 )

Cross currency interest rate swaps contracts:

Amount of gain or (loss) reclassified from AOCI into income — — — 83 — — — — 83 —

Amount of gain or (loss) recognized in AOCI $ — — — 16 — — — — 566 —

Form 10-Q

9

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As of March 29, 2026, and December 28, 2025, the following amounts were recorded on the Consolidated Balance Sheet related to cumulative basis adjustment for fair value hedges:

Line item in the Consolidated Balance Sheet in which the hedged item is included Carrying Amount of the Hedged Liability

Cumulative Amount of Fair Value

Hedging Gain/ (Loss) Included in the

Carrying Amount of the Hedged Liability

(Dollars in Millions) March 29, 2026 December 28, 2025 March 29, 2026 December 28, 2025

Long-term Debt $ 7,360 8,318 ( 647 ) ( 694 )

The following table is the effect of derivatives not designated as hedging instruments for the fiscal first quarters ended 2026 and 2025:

Gain/(Loss)

Recognized In

Income on Derivative

(Dollars in Millions) Location of

Gain /(Loss)

Recognized in

Income on Derivative Fiscal First Quarter Ended

Derivatives Not Designated as Hedging Instruments March 29, 2026 March 30, 2025

Foreign Exchange Contracts Other (income) expense $( 65 ) 62

The following table is the effect of net investment hedges for the fiscal first quarters ended in 2026 and 2025:

Gain/(Loss)

Recognized In

Accumulated OCI

Location of Gain or (Loss)

Reclassified from Accumulated OCI Into Income Gain/(Loss) Reclassified From

Accumulated OCI

Into Income

(Dollars in Millions) March 29, 2026 March 30, 2025 March 29, 2026 March 30, 2025

Debt $ 213

( 316 )

Interest (income) expense

Cross Currency interest rate swaps $ 217

840

Interest (income) expense

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The Company holds equity investments with readily determinable fair values and equity investments without readily determinable fair values. The Company has elected to measure equity investments that do not have readily determinable fair values at cost minus impairment, if any, plus or minus changes resulting from observable price changes in orderly transactions for the identical or a similar investment of the same issuer.

The following table is a summary of the activity related to equity investments:

December 28, 2025 March 29, 2026

(Dollars in Millions) Carrying Value Changes in Fair Value Reflected in Net Income (1)

(Sales)/ Purchases/Other (2)

Carrying Value Non Current Other Assets

Equity Investments with readily determinable value $ 665 43 ( 5 ) 703 703

Equity Investments without readily determinable value $ 910 46 ( 68 ) 888 888

(1) Recorded in Other (income)/expense, net

(2) Other includes impact of currency

Fair value is the exit price that would be received to sell an asset or paid to transfer a liability. Fair value is a market-based measurement determined using assumptions that market participants would use in pricing an asset or liability. In accordance with ASC 820, a three-level hierarchy was established to prioritize the inputs used in measuring fair value. The levels within the hierarchy are described below with Level 1 inputs having the highest priority and Level 3 inputs having the lowest.

The fair value of a derivative financial instrument (i.e., forward foreign exchange contracts, interest rate contracts) is the aggregation by currency of all future cash flows discounted to its present value at the prevailing market interest rates and subsequently converted to the U.S. Dollar at the current spot foreign exchange rate. The Company does not believe that fair values of these derivative instruments materially differ from the amounts that could be realized upon settlement or maturity, or that the changes in fair value will have a material effect on the Company’s results of operations, cash flows or financial position. The Company also holds equity investments which are classified as Level 1 and debt securities which are classified as Level 2. The Company holds acquisition related contingent liabilities based upon certain regulatory and commercial events, which are classified as Level 3, whose values are determined using discounted cash flow methodologies or similar techniques for which the determination of fair value requires significant judgment or estimations.

The following three levels of inputs are used to measure fair value:

Level 1 — Quoted prices in active markets for identical assets and liabilities.

Level 2 — Significant other observable inputs.

Level 3 — Significant unobservable inputs.

Form 10-Q

11

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The Company’s significant financial assets and liabilities measured at fair value as of March 29, 2026 and December 28, 2025 were as follows:

March 29, 2026 December 28, 2025

(Dollars in Millions) Level 1 Level 2 Level 3 Total Total (1)

Derivatives designated as hedging instruments:

Assets:

Forward foreign exchange contracts $ — 549 — 549 686

Interest rate contracts (2)

— 610 — 610 589

Total — 1,159 — 1,159 1,275

Liabilities:

Forward foreign exchange contracts — 418 — 418 413

Interest rate contracts (2)

— 5,386 — 5,386 5,848

Total — 5,804 — 5,804 6,261

Derivatives not designated as hedging instruments:

Assets:

Forward foreign exchange contracts — 47 — 47 38

Liabilities:

Forward foreign exchange contracts — 49 — 49 46

Other Investments:

Equity investments (3)

703 — — 703 665

Debt securities (4)

— 6,675 — 6,675 2,854

Other Liabilities:

Contingent consideration (5)

$ — — 754 754 753

Gross to Net Derivative Reconciliation March 29, 2026 December 28, 2025

(Dollars in Millions)

Total Gross Assets $ 1,206 1,313

Credit Support Agreement (CSA) ( 1,094 ) ( 1,308 )

Total Net Asset 112 5

Total Gross Liabilities 5,853 6,307

Credit Support Agreement (CSA) ( 5,829 ) ( 5,903 )

Total Net Liabilities $ 24 404

Summarized information about changes in liabilities for contingent consideration for the fiscal first quarters ended March 29, 2026 and March 30, 2025 is as follows:

March 29, 2026 March 30, 2025

(Dollars in Millions)

Beginning Balance $ 753 1,217

Changes in estimated fair value (6)

1 14

Additions — —

Payments — —

Ending Balance $ 754 1,231

(1) 2025 assets and liabilities are all classified as Level 2 with the exception of equity investments of $ 665 million, which are classified as Level 1 and contingent consideration of $ 753 million, classified as Level 3.

(2) Includes cross currency interest rate swaps and interest rate swaps.

(3) Classified as non-current other assets.

12

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(4) Classified within cash equivalents and current marketable securities.

(5) Classified as non-current other liabilities.

(6) Ongoing fair value adjustment amounts are primarily recorded in Research and Development expense.

As of March 29, 2026 and December 28, 2025, cash and cash equivalents includes money market funds of $ 5,089 million and $ 5,993 million, respectively, which would be considered level 1 in the fair value hierarchy

The Company's cash, cash equivalents and current marketable securities as of March 29, 2026 comprised:

(Dollars in Millions) Carrying

Amount

Estimated

Fair Value

Cash & Cash

Equivalents

Current

Marketable

Securities

Cash $ 3,310

3,310

3,310

U.S. reverse repurchase agreements 6,253

6,253

6,253

Money market funds 5,089

5,089

5,089

Time deposits (1)

724

724

724

Subtotal 15,376

15,376

15,376

U.S. Gov’t securities 6,225

6,225

6,207

18

Other sovereign securities 234

234

76

158

Corporate and other debt securities 216

216

29

187

Subtotal available for sale debt (2)

$ 6,675

6,675

6,312

363

Total cash, cash equivalents and current marketable securities $ 22,051

22,051

21,688

363

(1) Held to maturity investments are reported at amortized cost and gains or losses are reported in earnings.

(2) Available for sale debt securities are reported at fair value with unrealized gains and losses reported net of taxes in other comprehensive income.

As of the fiscal year ended December 28, 2025, the carrying amount of cash, cash equivalents and current marketable securities was the same as the estimated fair value.

Fair value of government securities and obligations and corporate debt securities was estimated using quoted broker prices and significant other observable inputs.

The Company classifies all highly liquid investments with stated maturities of three months or less from date of purchase as cash equivalents and all highly liquid investments with stated maturities of greater than three months from the date of purchase as current marketable securities. Available for sale securities with stated maturities of greater than one year from the date of purchase are available to fund current operations and are classified as current marketable securities.

The contractual maturities of the available for sale securities as of March 29, 2026 are as follows:

(Dollars in Millions) Cost Basis Fair Value

Due within one year $ 6,659

6,659

Due after one year through five years 16

16

Due after five years through ten years —

Total debt securities $ 6,675

6,675

Form 10-Q

13

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Financial instruments not measured at fair value

The following financial liabilities are held at carrying amount on the consolidated balance sheet as of March 29, 2026:

(Dollars in Millions) Carrying

Amount

Estimated

Fair Value

Financial Liabilities

Current Debt $ 17,460 17,455

Non-Current Debt

0.95 % Notes due 2027

1,499 1,439

2.90 % Notes due 2028

1,499 1,470

1.150 % Notes due 2028 ( 750 MM Euro 1.1541 )

863 826

4.55 % Notes due 2028

749 758

4.80 % Notes due 2029

1,147 1,174

6.95 % Notes due 2029

299 327

2.70 % Notes due 2029 ( 600 MM Euro 1.1541 )

692 685

1.30 % Notes due 2030

1,702 1,544

4.70 % Notes due 2030

996 1,018

4.90 % Notes due 2031

1,146 1,180

3.20 % Notes due 2032 ( 700 MM Euro 1.1541 )

805 798

4.85 % Notes due 2032

1,243 1,275

4.95 % Notes due 2033

499 518

4.375 % Notes due 2033

853 845

3.050 % Notes due 2033 ( 700 MM Euro 1.1541 )

806 786

4.95 % Notes due 2034

847 882

1.650 % Notes due 2035 ( 1.5 B Euro 1.1541 )

1,722 1,463

5.00 % Notes due 2035

1,244 1,275

3.35 % Notes due 2036 ( 800 MM Euro 1.1541 )

919 892

3.587 % Notes due 2036

925 903

5.95 % Notes due 2037

995 1,085

3.625 % Notes due 2037

1,414 1,333

3.350 % Notes due 2037 ( 1.0 B Euro 1.1541 )

1,151 1,100

3.40 % Notes due 2038

994 855

5.85 % Notes due 2038

697 754

4.50 % Notes due 2040

542 512

2.10 % Notes due 2040

902 687

4.85 % Notes due 2041

298 292

4.50 % Notes due 2043

497 453

3.55 % Notes due 2044 ( 1.0 B Euro 1.1541 )

1,144 1,057

3.60 % Notes due 2045 ( 700 MM Euro 1.1541 )

802 741

3.73 % Notes due 2046

1,980 1,565

3.75 % Notes due 2047

877 778

3.50 % Notes due 2048

744 555

2.25 % Notes due 2050

864 572

5.25 % Notes due 2054

843 831

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3.70 % Notes due 2055 ( 1.0 B Euro 1.1541 )

1,148 1,027

2.45 % Notes due 2060

1,118 660

Other 62 77

Total Non-Current Debt $ 37,527 34,992

The weighted average effective interest rate on non-current debt is 3.56 %.

The excess of the carrying value over the estimated fair value of debt was $ 1.7 billion at December 28, 2025.

Fair value of the non-current debt was estimated using market prices, which were corroborated by quoted broker prices and significant other observable inputs.

The current debt balance as of March 29, 2026, includes $ 15.7  billion of commercial paper which has a weighted average interest rate of 3.67 % and a weighted average maturity of approximately two months . The current debt balance as of December 28, 2025 included $ 6.5  billion of commercial paper which has a weighted average interest rate of 3.81 % and a weighted average maturity of approximately two months .

Note 5 — Income taxes

The worldwide effective income tax rates for the fiscal first quarter of 2026 and 2025 were 12.6 % and 19.3 %, respectively. The primary drivers for year over year change in the Company’s effective tax were:

• In the fiscal first quarter of 2025, the Company reversed approximately $ 7.0  billion related to the talc reserve which was recorded at approximately 22 %.

• Additional tax benefits in the fiscal first quarter of 2026 related to the Company’s share-based equity compensation programs that either vested or were exercised during the fiscal first quarters of 2026 and 2025, which reduced the effective tax rate by 5.1 % and 0.4 %, respectively.

As of March 29, 2026, the Company had approximately $ 2.6 billion of liabilities from unrecognized tax benefits. The Company conducts business and files tax returns in numerous countries and currently has tax audits in progress in several jurisdictions. With respect to the United States, the Internal Revenue Service has completed its audit for the tax years through 2016 and the audit for tax years 2017 through 2020 is ongoing. In other major jurisdictions where the Company conducts business, the years that remain open to tax audit go back to the year 2014.

Form 10-Q

15

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Note 6 — Pensions and other benefit plans

Components of net periodic benefit cost

Net periodic benefit costs for the Company’s defined benefit retirement plans and other benefit plans include the following components:

Fiscal First Quarter Ended

Retirement Plans Other Benefit Plans

(Dollars in Millions) March 29, 2026 March 30, 2025 March 29, 2026 March 30, 2025

Service cost $ 236 214 80 72

Interest cost 360 351 52 54

Expected return on plan assets ( 639 ) ( 587 ) ( 2 ) ( 2 )

Amortization of prior service cost/(credit)

( 46 ) ( 46 ) — —

Recognized actuarial (gains)/losses

69

83

26

16

Net periodic benefit cost/(credit) $( 20 ) 15 156 140

The service cost component of net periodic benefit cost is presented in the same line items on the Consolidated Statement of Earnings where other employee compensation costs are reported, including Cost of products sold, Research and development expense, and Selling, marketing and administrative expenses. All other components of net periodic benefit cost are presented as part of Other (income) expense, net on the Consolidated Statement of Earnings.

Company contributions

For the fiscal three months ended March 29, 2026, the Company contributed $ 35 million and $ 5 million to its U.S. and international retirement plans, respectively. The Company plans to continue to fund its U.S. defined benefit plans to comply with the Pension Protection Act of 2006. International plans are funded in accordance with local regulations.

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Note 7 — Accumulated other comprehensive income

Components of other comprehensive income/(loss) consist of the following:

(Dollars in Millions) Foreign

Currency

Translation

Gain/

(Loss) On

Securities

Employee

Benefit

Plans

Gain/

(Loss) On

Derivatives

& Hedges

Total

Accumulated

Other

Comprehensive

Income/(Loss)

December 28, 2025 $( 13,947 ) — ( 693 ) ( 290 ) ( 14,930 )

Net change 334 — 39 ( 274 ) 99

March 29, 2026 ( 13,613 ) — ( 654 ) ( 564 ) ( 14,831 )

Amounts in accumulated other comprehensive income are presented net of the related tax impact. Foreign currency translation is not adjusted for income taxes where it relates to permanent investments in international subsidiaries. For additional details on comprehensive income see the Consolidated Statements of Comprehensive Income.

Details on reclassifications out of Accumulated Other Comprehensive Income:

Gain/(Loss) On Securities - reclassifications released to Other (income) expense, net.

Employee Benefit Plans - reclassifications are included in net periodic benefit cost. See Note 6 for additional details.

Gain/(Loss) On Derivatives & Hedges - reclassifications to earnings are recorded in the same account as the underlying transaction. See Note 4 for additional details.

Note 8 — Earnings per share

The following is a reconciliation of basic net earnings per share to diluted net earnings per share:

Fiscal First Quarter Ended

(Shares in Millions) March 29, 2026 March 30, 2025

Basic net earnings per share $ 2.17 4.57

Average shares outstanding — basic 2,408.7 2,407.2

Potential shares exercisable under stock option plans 100.6 69.0

Less: shares which could be repurchased under treasury stock method ( 64.1 ) ( 52.4 )

Average shares outstanding — diluted 2,445.2 2,423.8

Diluted net earnings per share $ 2.14 4.54

(Shares in Millions)

The diluted net earnings per share calculation excluded the following number of shares related to stock options, as the exercise price of these options was greater than the average market value of the Company’s stock.

3.5 60.9

Form 10-Q

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Note 9 — Segments of business and geographic areas

The Company is organized into two business segments: Innovative Medicine and MedTech.

The Company’s chief operating decision maker (CODM) is the Chief Executive Officer (Principal Executive Officer). For the Innovative Medicine and MedTech segments, the CODM uses segment income before tax to allocate resources (including employees, financial, and capital resources) for each segment predominantly in the annual forecasting process. The CODM considers planning-to-actual variances on a quarterly basis to assess performance and make decisions about allocating resources to the segments.

Sales by segment of business

Fiscal First Quarter Ended

(Dollars in Millions) March 29,

2026 March 30,

2025 Percent

Change

INNOVATIVE MEDICINE

Oncology

U.S.

$ 3,615 3,013 20.0   %

International

3,358 2,664 26.0

Worldwide

6,973 5,678 22.8

DARZALEX

U.S.

2,208 1,829 20.7

International

1,756 1,409 24.7

Worldwide

3,964 3,237 22.5

CARVYKTI

U.S.

433 318 36.2

International

164 51 *

Worldwide

597 369 62.1

TECVAYLI

U.S.

127 105 20.6

International

74 46 63.1

Worldwide

202 151 33.5

TALVEY

U.S.

101 68 48.5

International

51 18 *

Worldwide

152 86 76.7

RYBREVANT/ LAZCLUZE

U.S.

175 113 55.1

International

82 28 *

Worldwide

257 141 82.7

ERLEADA

U.S.

342 292 17.3

International

607 479 26.7

Worldwide

949 771 23.1

IMBRUVICA

U.S.

143 235 ( 39.1 )

International

517 474 9.1

Worldwide

660 709 ( 6.9 )

18

Table of Contents

Fiscal First Quarter Ended

(Dollars in Millions) March 29,

2026 March 30,

2025 Percent

Change

OTHER ONCOLOGY (1)

U.S.

85 54 58.8

International

106 160 ( 33.9 )

Worldwide

192 214 ( 10.6 )

Immunology

U.S.

1,855 2,196 ( 15.5 )

International

1,524 1,510 0.9

Worldwide

3,380 3,707 ( 8.8 )

TREMFYA

U.S.

1,042 599 73.9

International

566 356 58.9

Worldwide

1,608 956 68.3

SIMPONI / SIMPONI ARIA

U.S.

269 292 ( 7.8 )

International

378 366 3.0

Worldwide

647 659 ( 1.7 )

REMICADE

U.S.

269 314 ( 14.4 )

U.S. Exports

18 10 78.6

International

136 143 ( 4.8 )

Worldwide

422 467 ( 9.5 )

STELARA

U.S.

220 981 ( 77.6 )

International

435 644 ( 32.4 )

Worldwide

656 1,625 ( 59.7 )

OTHER IMMUNOLOGY

U.S.

38 1 *

International

9 0 *

Worldwide

46 1 *

Neuroscience

U.S.

1,494 968 54.3

International

681 679 0.3

Worldwide

2,175 1,647 32.0

SPRAVATO

U.S.

406 276 47.0

International

61 43 42.4

Worldwide

468 320 46.4

CAPLYTA (2)

U.S.

270 — *

International

— — —

Worldwide

270 — *

Form 10-Q

19

Table of Contents

Fiscal First Quarter Ended

(Dollars in Millions) March 29,

2026 March 30,

2025 Percent

Change

INVEGA SUSTENNA / XEPLION / INVEGA TRINZA / TREVICTA

U.S.

758 625 21.2

International

280 277 1.1

Worldwide

1,038 903 15.0

CONCERTA / methylphenidate

U.S.

22 38 ( 43.4 )

International

115 110 4.3

Worldwide

136 148 ( 8.0 )

OTHER NEUROSCIENCE

U.S.

38 28 32.6

International

224 248 ( 9.7 )

Worldwide

262 277 ( 5.4 )

Pulmonary Hypertension (PH)

U.S.

831 744 11.7

International

304 281 8.2

Worldwide

1,135 1,025 10.7

UPTRAVI

U.S. 385 365 5.4

International 98 86 14.3

Worldwide 483 451 7.1

OPSUMIT/OPSYNVI

U.S. 433 363 19.3

International 172 159 8.7

Worldwide 606 522 16.1

OTHER PULMONARY HYPERTENSION

U.S.

12 15 ( 21.1 )

International 34 37 ( 8.3 )

Worldwide 46 52 ( 12.1 )

Infectious Diseases (ID)

U.S.

342 315 8.6

International

547 487 12.2

Worldwide

889 802 10.8

EDURANT / rilpivirine

U.S.

7 8 ( 13.1 )

International

402 350 14.8

Worldwide

409 358 14.1

PREZISTA / PREZCOBIX / REZOLSTA / SYMTUZA

U.S.

334 305 9.5

International

109 98 11.2

Worldwide

443 403 10.0

20

Table of Contents

Fiscal First Quarter Ended

(Dollars in Millions) March 29,

2026 March 30,

2025 Percent

Change

OTHER INFECTIOUS DISEASES

U.S.

1 2 ( 56.9 )

International

36 39 ( 8.3 )

Worldwide

37 41 ( 10.4 )

Cardiovascular / Metabolism / Other (CVM)

U.S. 734 855 ( 14.2 )

International 142 158 ( 10.4 )

Worldwide 876 1,013 ( 13.6 )

XARELTO

U.S. 642 690 ( 7.0 )

International — — —

Worldwide 642 690 ( 7.0 )

OTHER

U.S. 91 165 ( 44.5 )

International 142 158 ( 10.4 )

Worldwide 233 323 ( 27.8 )

Total PH, ID, CVM

U.S. 1,907 1,914 ( 0.4 )

International 993 926 7.1

Worldwide 2,899 2,840 2.1

TOTAL INNOVATIVE MEDICINE

U.S. 8,871 8,092 9.6

International 6,555 5,781 13.4

Worldwide 15,426 13,873 11.2

MEDTECH

Cardiovascular

U.S. 1,399 1,261 10.9

International 978 842 16.1

Worldwide 2,377 2,103 13.0

ELECTROPHYSIOLOGY

U.S. 736 684 7.6

International 753 638 18.0

Worldwide 1,489 1,323 12.6

ABIOMED

U.S. 389 339 14.5

International 100 81 23.5

Worldwide 488 420 16.3

SHOCKWAVE

U.S. 242 206 17.8

International 63 52 21.3

Worldwide 305 258 18.5

Form 10-Q

21

Table of Contents

Fiscal First Quarter Ended

(Dollars in Millions) March 29,

2026 March 30,

2025 Percent

Change

OTHER CARDIOVASCULAR

U.S. 32 32 0.7

International 62 72 ( 13.4 )

Worldwide 94 103 ( 9.1 )

Surgery

U.S. 1,046

1,002

4.4

International 1,465

1,394

5.1

Worldwide 2,511

2,396

4.8

ADVANCED

U.S. 477 457 4.2

International 646 616 4.9

Worldwide 1,123 1,073 4.6

GENERAL

U.S. 569 544 4.5

International 819 778 5.2

Worldwide 1,388 1,323 4.9

Vision

U.S. 579 566 2.4

International 785 713 10.1

Worldwide 1,365 1,279 6.7

CONTACT LENSES / OTHER

U.S. 468 452 3.7

International 501 467 7.2

Worldwide 969 919 5.5

SURGICAL

U.S. 111 114 ( 2.9 )

International 285 246 15.6

Worldwide 396 361 9.7

Orthopaedics*

U.S. 1,435

1,384

3.7

International 948

857

10.6

Worldwide 2,383

2,241

6.3

HIPS

U.S. 277

263

5.2

International 159

146

8.9

Worldwide 436

409

6.5

KNEES

U.S. 239

231

3.3

International 181

158

14.6

Worldwide 420

389

7.9

22

Table of Contents

Fiscal First Quarter Ended

(Dollars in Millions) March 29,

2026 March 30,

2025 Percent

Change

TRAUMA

U.S. 532

502

6.1

International 301

270

11.4

Worldwide 833

772

8.0

SPINE, SPORTS & OTHER

U.S. 387

388

( 0.1 )

International 307

283

8.4

Worldwide 694

671

3.5

TOTAL MEDTECH

U.S. 4,459 4,213 5.9

International 4,177 3,807 9.7

Worldwide 8,636 8,020 7.7

WORLDWIDE

U.S. 13,330 12,305 8.3

International 10,732 9,588 11.9

Worldwide $ 24,062 21,893 9.9 %

*    Percentage greater than 100% or not meaningful

(1) Includes the sales of ZYTIGA which were previously disclosed separately

(2) Acquired with Intra-Cellular Therapies on April 2, 2025

Adjustments to revenue recognized as a result of changes in estimates for the Company's most significant U.S. rebates and discounts liability balances for products shipped in previous periods were approximately 4.7 % and 4.6 % of U.S. Innovative Medicine revenue during the fiscal first quarter of 2026 and 2025, respectively.

*In October 2025, the Company announced its intention to separate its Orthopaedics business. The Company continues to explore multiple paths to effect the planned separation with a targeted completion within 18 to 24 months after the initial announcement.

Form 10-Q

23

Table of Contents

Segment income before tax

Fiscal First Quarter Ended

(Dollars in Millions) March 29,

2026 March 30,

2025

Innovative Medicine (1)

MedTech (2)

Total Innovative Medicine (1)

MedTech (2)

Total

Sales to customers $ 15,426 8,636 13,873 8,020

Cost of products sold 4,390 3,701 4,020 3,326

Selling, marketing and administrative 2,918 2,906 2,261 2,656

Research and development expense 2,813 714 2,548 677

Other segment items (3)

( 12 ) 76 ( 166 ) ( 60 )

Segment income before tax $ 5,317 1,239 6,556 5,210 1,421 6,631

(Income)/Expense not allocated to segments (4)

566 ( 7,000 )

Earnings before provision for taxes on income $ 5,990 $ 13,631

(1) Innovative Medicine includes:

• Intangible amortization expense of $ 0.8  billion and $ 0.6  billion in the fiscal first quarters of 2026 and 2025, respectively.

(2)     MedTech includes:

• Intangible amortization expense of $ 0.5  billion in both the fiscal first quarters of 2026 and 2025.

• Orthopaedics Separation related charge of $ 0.1  billion in the fiscal first quarter of 2026.

• Acquisition and integration related expense of $ 0.1  billion in the fiscal first quarter of 2025, primarily related to Shockwave.

(3)      Other segment items for each reportable segment include other income and expense (gains and losses on divestitures and gains and losses on sale of assets), restructuring activities and impairment charges related to in-process research and development

(4) Amounts not allocated to segments include interest (income)/expense and general corporate (income)/expense. The fiscal first quarter of 2026 includes charges for talc matters of $ 0.3  billion. The fiscal first quarter of 2025 includes approximately $ 7.0  billion related to the talc reserve reversal.

Identifiable Assets

(Dollars in Millions) March 29, 2026 December 28, 2025

Innovative Medicine $ 78,118 78,057

MedTech 86,179 86,482

Total 164,297

164,539

General corporate (1)

36,597 34,671

Worldwide total $ 200,894 199,210

(1) General corporate includes cash, cash equivalents, marketable securities and other corporate assets.

Additions to Property,

Plant & Equipment Depreciation and

Amortization

Fiscal Three Months Ended

(Dollars in Millions) March 29, 2026 March 30, 2025 March 29, 2026 March 30, 2025

Innovative Medicine $ 508 276 $ 1,036 884

MedTech 509 480 903 836

Segments total 1,017 756 1,939 1,720

General corporate 32 39 65 52

Worldwide total $ 1,049 795 $ 2,004 1,772

24

Table of Contents

Sales by geographic area

Fiscal First Quarter Ended

(Dollars in Millions) March 29, 2026 March 30, 2025 Percent

Change

United States $ 13,330 12,305 8.3 %

Europe 5,848 5,110 14.5

Western Hemisphere, excluding U.S. 1,293 1,167 10.8

Asia-Pacific, Africa 3,591 3,311 8.5

Total $ 24,062 21,893 9.9 %

Note 10 — Acquisitions, divestitures and other arrangements

Business combinations

Acquisitions of a business are accounted for as business combinations applying the acquisition method of accounting. Under this method, the assets acquired and liabilities assumed are recorded at their respective fair values as of the acquisition date in the Company’s consolidated financial statements. The excess of the purchase price over the fair value of the acquired net assets, where applicable, is recorded as goodwill. The results of operations of these acquisitions have been included in the Company’s financial statements from their respective dates of acquisition.

In the fiscal first quarter of 2026, there were no material business combinations.

2025 Transactions

During the fiscal year 2025, the Company acquired Halda Therapeutics OpCo, Inc. (Halda Therapeutics) and Intra-Cellular Therapies, Inc. (Intra-Cellular) for a total of $ 17.5  billion, net of cash acquired.

Halda Therapeutics

On December 26, 2025, the Company completed the acquisition of Halda Therapeutics, a clinical-stage biotechnology company with proprietary Regulated Induced Proximity TArgeting Chimera (RIPTAC TM ) platform to develop oral, targeting therapies for multiple types of solid tumors, including prostate cancer, in an all-cash merger transaction for total consideration transferred of approximately $ 3.05  billion, net of cash acquired. The acquisition was accounted for as a business combination and the results of operations and goodwill are included in the Innovative Medicine segment as of the acquisition date. Included in the total consideration transferred was $ 0.2  billion of acquisition-related costs, primarily related to post-closing compensation expense due to the acceleration of equity awards. This expense was recorded in Other (income) expense, net. Acquisition related costs before tax for the fiscal first quarter of 2026 were not material.

The fair value of the assets acquired is $ 3.4  billion, which primarily relates to acquired in-process research and development (IPR&D) of $ 2.8  billion and goodwill of $ 0.6  billion. The fair value of the liabilities assumed is $ 0.6  billion, primarily related to deferred taxes. These values are preliminary and based on the best estimate of management, which is subject to change within the measurement period. As of the fiscal first quarter ended March 29, 2026, there have been no material measurement period adjustments.

Intra-Cellular

On April 2, 2025, the Company completed the acquisition of Intra-Cellular, a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system disorders. This acquisition advances the Company’s industry-leading portfolio in mental health with the addition of CAPLYTA (lumateperone), the first and only U.S. FDA-approved treatment for bipolar I and II depression as an adjunctive therapy and monotherapy and is also approved for the treatment of schizophrenia in adults. This acquisition also includes a promising clinical-stage pipeline with best-in-class potential in generalized anxiety disorder and Alzheimer’s disease-related psychosis and agitation.

The Company acquired all the outstanding shares of Intra-Cellular’s common stock for $ 132.00 per share in an all-cash merger transaction for total consideration transferred of $ 14.5  billion. The acquisition was accounted for as a business combination and the results of operations and goodwill are included in the Innovative Medicine segment as of the acquisition date. In addition, acquisition-related costs before tax incurred during the fiscal year 2025 were $ 0.4  billion, of which $ 0.1  billion related to post-closing compensation expense due to the acceleration of equity awards and were recorded to Other (income) expense, net. Acquisition related costs before tax for the fiscal first quarter of 2026 were not material.

Form 10-Q

25

Table of Contents

The fair value of the assets acquired is $ 17.5  billion, which primarily relates to acquired in-process research and development (IPR&D) of $ 8.3  billion, an amortizable intangible asset of $ 5.2  billion, goodwill of $ 2.9  billion and other current and non-current assets of $ 1.1  billion. The fair value of the liabilities assumed is $ 3.0  billion, primarily related to deferred taxes. As of the fiscal first quarter ended March 29, 2026, there have been no material measurement period adjustments. During the fiscal fourth quarter of 2025, the U.S. FDA approved CAPLYTA as an adjunctive therapy with anti-depressants for the treatment of major depressive disorder in adults. This IPR&D asset was reclassified to a definite lived asset and began amortizing in the fiscal fourth quarter of 2025.

Asset acquisitions

If it is determined that the acquired set does not meet the definition of a business under the acquisition method of accounting, the transaction is accounted for as an asset acquisition. In this case, no goodwill is recorded, acquired in-process research and development (IPR&D) with no alternative future use is immediately recorded as research and development expense and contingent consideration is recorded when the related event occurs.

In the fiscal first quarters of 2026 and 2025, there were no material asset acquisitions.

Divestitures

In the fiscal first quarters of 2026 and 2025, there were no material divestitures.

Other arrangements

In the fiscal first quarter of 2026, the Company entered into a co-funding agreement with Royalty Pharma plc. (Royalty Pharma) under which the Company will receive up to a total of $ 0.5  billion during the fiscal years 2026 and 2027 to support the clinical development of JNJ-4804, a co-antibody therapy in development to treat chronic immune-mediated diseases. As there is a substantive and genuine transfer of risk to Royalty Pharma, the development funding will be recognized as an obligation to perform contractual services. Accordingly, the funding the Company receives will be recognized as a reduction to research & development expense as the Company performs its contractual services .

If successful, upon regulatory approval of certain indications in the U.S. or other major markets, Royalty Pharma will receive approval-based fixed milestone payments up to approximately $ 0.5  billion and will also be eligible to receive sales-based milestone payments and low-single digit royalties based on commercial sales.

Note 11 — Legal proceedings

Johnson & Johnson and certain of its subsidiaries are involved in various lawsuits and claims regarding product liability; intellectual property; commercial; indemnification and other matters; governmental investigations; and other legal proceedings that arise from time to time in the ordinary course of their business.

The Company records accruals for loss contingencies associated with these legal matters when it is probable that a liability will be incurred, and the amount of the loss can be reasonably estimated. As of March 29, 2026, the Company has determined that the liabilities associated with certain litigation matters are probable and can be reasonably estimated. The Company has accrued for these matters and will continue to monitor each related legal issue and adjust accruals as might be warranted based on new information and further developments in accordance with ASC 450-20-25. For these and other litigation and regulatory matters discussed below for which a loss is probable or reasonably possible, the Company is unable to estimate the possible loss or range of loss beyond the amounts accrued. Amounts accrued for legal contingencies often result from a complex series of judgments about future events and uncertainties that rely heavily on estimates and assumptions including timing of related payments. The ability to make such estimates and judgments can be affected by various factors including, among other things, whether damages sought in the proceedings are unsubstantiated or indeterminate; scientific and legal discovery has not commenced or is not complete; proceedings are in early stages; matters present legal uncertainties; there are significant facts in dispute; procedural or jurisdictional issues; the uncertainty and unpredictability of the number of potential claims; ability to achieve comprehensive multi-party settlements; complexity of related cross-claims and counterclaims; and/or there are numerous parties involved. To the extent adverse awards, judgments or verdicts have been rendered against the Company, the Company does not record an accrual until a loss is determined to be probable and can be reasonably estimated.

In the Company’s opinion, based on its examination of these matters, its experience to date and discussions with counsel, the ultimate outcome of legal proceedings, net of liabilities accrued in the Company’s balance sheet, is not expected to have a material adverse effect on the Company’s financial position. However, the resolution of, or increase in accruals for, one or more of these

matters in any reporting period may have a material adverse effect on the Company’s results of operations and cash flows for that period.

Matters concerning talc

As of March 29, 2026, there are approximately 75,000 plaintiffs in the United States with direct claims against the Company and its affiliates in pending lawsuits regarding injuries allegedly due to use of body powders containing talc, primarily JOHNSON’S Baby Powder.

In talc cases that have gone to trial, the Company has obtained a number of defense verdicts, but there also have been verdicts against the Company, many of which have been reversed on appeal. The Company continues to believe that it has strong legal grounds to contest all the talc verdicts that it has appealed. Notwithstanding the Company’s confidence in the safety of its talc products, in certain circumstances the Company has settled cases.

In an effort to expeditiously resolve the litigation for the overwhelming majority of claimants, beginning in October 2021, the Company underwent a series of corporate restructurings which ultimately resulted in two entities, Red River Talc, LLC (Red River) and Pecos River Talc LLC (Pecos River), being assigned all liabilities related in any way to injury or damage, or alleged injury or damage, sustained or incurred in the purchase or use of, or exposure to, talc, including talc contained in any product, or to the risk of, or responsibility for, any such damage or injury, except for any liabilities for which the exclusive remedy is provided under a workers’ compensation statute or act. As a result of the restructurings, all claims in North America related to ovarian and other gynecological cancers were separated and allocated to Red River, and mesothelioma, governmental unit and certain other claims in North America were allocated to Pecos River. In connection with these restructurings, the Company filed a series of three Chapter 11 bankruptcy proceedings. Ultimately, each of the bankruptcy proceedings was dismissed and, as a result, the Company reversed substantially all, or approximately $ 7.0  billion, from amounts previously reserved for the bankruptcy resolution in the fiscal first quarter of 2025. Litigation in the tort system recommenced.

As of the first quarter of 2026, the total present value of the reserve for talc related matters is approximately $ 3.4  billion, comprising previously executed settlement agreements, litigation defense and other costs. Approximately one-third of the reserve is recorded as a current liability.

As in years prior, both ovarian cancer and mesothelioma trials are being scheduled in various state courts throughout 2026 and beyond. In the ovarian cancer multi-district litigation in New Jersey, the court is addressing the Company's Daubert motions related to general causation, specific causation, and certain asbestos testing methods. In January 2026, the Special Master issued her Report and Recommendation related to general causation, excluding certain opinions by plaintiff experts, but also allowing other opinions to proceed. The Company has filed an appeal of the Report and Recommendation to the District Court. The remaining Daubert motions are expected to be decided in 2026. The Company also faces litigation in Canada.

In February 2018, a securities class action lawsuit was filed against the Company and certain named officers in the United States District Court for the District of New Jersey, alleging that the Company violated the federal securities laws by failing to disclose alleged asbestos contamination in body powders containing talc, primarily JOHNSON’S Baby Powder, and that purchasers of the Company’s shares suffered losses as a result. In April 2019, the Company moved to dismiss the complaint. In December 2019, the court denied, in part, the motion to dismiss. In December 2023, the court granted plaintiffs’ motion for class certification. In July 2025, the Third Circuit affirmed the court's order granting class certification. In September 2025, the Company petitioned the Third Circuit for rehearing or rehearing en banc, which was denied in October 2025. In February 2026, the Company filed a writ of certiorari with the United States Supreme Court regarding the Third Circuit’s decision, which the Supreme Court denied in April 2026.

In February 2019, the Company’s talc supplier, Imerys Talc America, Inc., and two of its affiliates, Imerys Talc Vermont, Inc. and Imerys Talc Canada, Inc. (collectively, Imerys), filed voluntary petitions for relief under Chapter 11 of the United States Code (the Bankruptcy Code) in the United States Bankruptcy Court for the District of Delaware. In February 2021, Cyprus Mines Corporation (Cyprus), which sold certain talc mines and assets to Imerys, filed a voluntary petition for relief under Chapter 11 of the Bankruptcy Code in the Delaware Bankruptcy Court. In July 2024, the Company, Imerys, and Cyprus and certain of their affiliates (including their parent entities), and the tort claimants' committees and future claimants' representatives appointed in the Imerys debtors' and Cyprus debtors' respective Chapter 11 cases, entered into a global settlement agreement (the Imerys Settlement Agreement) to resolve the parties' ongoing disputes, including disputes raised in the Imerys and Cyprus bankruptcies regarding (i) the Company's alleged obligations to indemnify Imerys and Cyprus for personal injury claims allegedly caused by exposure to talc contained in the Company's products and (ii) entitlements to proceeds of certain of the Company's insurance policies. In October 2024, the Delaware Bankruptcy Court entered an order approving the Imerys Settlement Agreement (the Settlement Order). Certain insurers have appealed the Settlement Order and sought a stay of the Settlement Order pending appeal, which the Delaware Bankruptcy Court denied in January 2025. In August 2025, the District Court denied the insurers' appeal of the Settlement Order. The insurers have appealed that decision to the Third Circuit.

Intellectual property

Certain subsidiaries of the Company are subject, from time to time, to legal proceedings and claims related to patent, trademark and other intellectual property matters arising out of their businesses. Many of these matters involve challenges to the scope and/or validity of patents that relate to various products and allegations that certain of the Company’s products infringe the intellectual property rights of third parties. Although these subsidiaries believe that they have substantial defenses to these challenges and allegations with respect to all significant patents, there can be no assurance as to the outcome of these matters. A loss in any of these cases could adversely affect the ability of these subsidiaries to sell their products, result in loss of sales due to loss of market exclusivity, require the payment of past damages and future royalties, and may result in a non-cash impairment charge for any associated intangible asset.

The Company’s Innovative Medicine subsidiaries have brought lawsuits against generic companies that have filed ANDAs with the U.S. FDA (or similar lawsuits outside of the United States) seeking to market generic versions of products sold by various subsidiaries of the Company prior to expiration of the applicable patents covering those products. These lawsuits typically include allegations of non-infringement and/or invalidity of patents listed in FDA’s publication “Approved Drug Products with Therapeutic Equivalence Evaluations” (commonly known as the Orange Book). In each of these lawsuits, the Company’s subsidiaries are seeking an order enjoining the defendant from marketing a generic version of a product before the expiration of the relevant patents (Orange Book Listed Patents). In the event the Company’s subsidiaries are not successful in an action, or any automatic statutory stay expires before the court rulings are obtained, the generic companies involved would have the ability, upon regulatory approval, to introduce generic versions of their products to the market resulting in the potential for substantial market share and revenue losses for the applicable products, and which may result in a non-cash impairment charge in any associated intangible asset. In addition, from time to time, the Company’s subsidiaries may settle these types of actions and such settlements can involve the introduction of generic versions of the products at issue to the market prior to the expiration of the relevant patents.

The Inter Partes Review (IPR) process with the United States Patent and Trademark Office (USPTO), created under the 2011 America Invents Act, is also being used at times by generic companies in conjunction with ANDAs and lawsuits to challenge the applicable patents.

Innovative Medicine

XARELTO

Beginning in March 2021, Janssen Pharmaceuticals, Inc., Bayer Pharma AG, Bayer AG, and Bayer Intellectual Property GmbH filed patent infringement lawsuits in United States district courts against generic manufacturers who have filed ANDAs seeking approval to market generic versions of XARELTO before expiration of certain Orange Book Listed Patents. The following entities are named defendants: Dr. Reddy’s Laboratories, Inc.; Dr. Reddy’s Laboratories, Ltd.; Lupin Limited; Lupin Pharmaceuticals, Inc.; Taro Pharmaceutical Industries Ltd.; Taro Pharmaceuticals U.S.A., Inc.; Teva Pharmaceuticals USA, Inc.; Mylan Pharmaceuticals Inc.; Mylan Inc.; Mankind Pharma Limited; Apotex Inc.; Apotex Corp.; Cipla Ltd.; Cipla USA Inc.; InvaGen Pharmaceuticals, Inc.; and Prinston Pharmaceuticals, Inc. The following U.S. patents are included in one or more cases: 9,539,218 and 10,828,310. In December 2025 and January 2026, the cases against Dr. Reddy's Laboratories, Inc.; Dr. Reddy's Laboratories, Ltd.; Lupin Limited; Lupin Pharmaceuticals, Inc.; Taro Pharmaceutical Industries Ltd.; Taro Pharmaceuticals U.S.A., Inc.; Teva Pharmaceuticals USA, Inc.; Mylan Pharmaceuticals Inc.; Mylan Inc.; Mankind Pharma Limited; Apotex Inc.; Apotex Corp.; Cipla Ltd.; Cipla USA Inc.; InvaGen Pharmaceuticals, Inc.; and Prinston Pharmaceuticals, Inc. were dismissed with prejudice. In January 2026, the Company entered into a confidential settlement agreement with Mankind Pharma Limited.

U.S. Patent No. 10,828,310 was also under consideration by the USPTO in an IPR proceeding. In July 2023, the USPTO issued a final written decision finding the claims of the patent invalid. In September 2023, Bayer Pharma AG filed an appeal to the U.S. Court of Appeals for the Federal Circuit. In September 2025, the Federal Circuit entered a decision affirming-in-part, vacating-in-part, and remanding for further proceedings. In January 2026, the USPTO entered judgment against petitioners upon remand.

INVEGA SUSTENNA

Beginning in January 2018, Janssen Pharmaceutica NV and Janssen Pharmaceuticals, Inc. filed patent infringement lawsuits in United States district courts against generic manufacturers who have filed ANDAs seeking approval to market generic versions of INVEGA SUSTENNA before expiration of the Orange Book Listed Patent. The following entities are named defendants: Pharmascience Inc.; Mallinckrodt PLC; Specgx LLC; Tolmar, Inc.; Eugia Pharma Specialties Ltd.; Eugia US, LLC; and Aurobindo Pharma USA, Inc. The following U.S. patent is included in one or more cases: 9,439,906. In February 2024, the district court issued a decision in the case against Tolmar Inc. finding that United States Patent No. 9,439,906 is not invalid. Tolmar previously stipulated to infringement of a subset of the claims, and based on a claim construction ruling, the district court entered a non-infringement order with respect to the remaining asserted claims. Tolmar has appealed the validity decision, and Janssen appealed the non-infringement decision. In March 2026, Janssen and Tolmar entered into a confidential settlement agreement.

Beginning in February 2018, Janssen Inc. and Janssen Pharmaceutica NV initiated a Statement of Claim under Section 6 of the Patented Medicines (Notice of Compliance) Regulations against generic manufacturers who have filed ANDSs seeking approval to market generic versions of INVEGA SUSTENNA before expiration of the listed patent. The following entity is a named defendant: Pharmascience Inc. The following Canadian patent is included in one or more cases: 2,655,335. In September 2024, the Supreme Court granted Pharmascience's motion to appeal the Federal Court's decision that the 2,655,335 Patent is not invalid.

ERLEADA

Beginning in January 2025, Aragon Pharmaceuticals, Inc., Janssen Inc. (collectively, Janssen Inc.), and Sloan-Kettering Institute for Cancer Research (SKI) initiated Statements of Claims under Section 6 of the Patented Medicines (Notice of Compliance) Regulations against Sandoz Canada Inc. (Sandoz) in response to Sandoz’s filing of ANDSs seeking approval to market 60 mg and 240 mg generic versions of ERLEADA before the expiration of CA Patent Nos. 3,008,345, 2,875,767, 2,885,415, and 3,128,331. Janssen Inc. and SKI are seeking orders enjoining Sandoz from marketing 60 mg and 240 mg generic versions of ERLEADA before the expiration of the relevant patents.

Beginning in June 2025, Aragon Pharmaceuticals, Inc., Janssen Biotech, Inc., The Regents of the University of California, and Sloan-Kettering Institute for Cancer Research initiated a patent infringement lawsuit in United States District Court for the District of New Jersey against Hetero Labs Limited Unit V and Hetero USA, Inc. who filed an ANDA seeking approval to market a 240 mg generic version of ERLEADA before the expiration of certain Orange Book Listed Patents. The following U.S. patents are included in the case: 8,445,507; 8,802,689; 9,338,159; 9,987,261; 9,481,663; 9,884,054; RE49,353; 10,849,888; 10,702,508; 11,963,952; 12,303,493; and 12,303,497.

SPRAVATO

Beginning in May 2023, Janssen Pharmaceuticals, Inc. and Janssen Pharmaceutica NV filed patent infringement lawsuits in United States district courts against generic manufacturers who have filed ANDAs seeking approval to market generic versions of SPRAVATO before expiration of certain Orange Book Listed Patents. The following entities are named defendants: Sandoz Inc. and Alkem Laboratories Ltd. The following U.S. patents are included in one or more cases: 10,869,844; 11,173,134; 11,311,500; and 11,446,260. A trial against Sandoz took place in February 2026. Post-trial briefing is ongoing.

CAPLYTA

Beginning in March 2024, Intra-Cellular Therapies, Inc. (Intra-Cellular) filed patent infringement lawsuits in the United States District Court for the District of New Jersey against generic manufacturers who have filed ANDAs seeking approval to market generic versions of CAPLYTA before expiration of certain Orange Book Listed Patents. The following entities are named defendants: Aurobindo Pharma Ltd., Aurobindo Pharma USA, Inc., Alkem Laboratories Ltd., MSN Laboratories Private Ltd., Zydus Pharmaceuticals (USA) Inc., and Zydus Lifesciences Ltd. The following U.S. Patents are included in one or more cases: RE 48,825; RE 48,839; 8,648,077; 9,168,258; 9,199,995; 9,616,061; 9,956,227; 10,117,867; 10,464,938; 10,960,009; 11,026,951; 11,753,419; 11,980,617; 12,070,459; 12,090,155; 12,122,792; 12,128,043; 12,409,176; and 12,410,195. In February 2026, Intra-Cellular and MSN Laboratories Private Ltd. entered into a confidential settlement agreement and the case was dismissed. In March 2026, Intra-Cellular and Alkem Laboratories Ltd. entered into a confidential settlement agreement and the case was dismissed.

UPTRAVI

Beginning in September 2025, Actelion Pharmaceuticals Ltd, Actelion Pharmaceuticals US, Inc. (collectively, Actelion), and Nippon Shinyaku Co. Ltd. filed a patent infringement lawsuit in the United States District Court for the District of New Jersey against generic manufacturers who have filed ANDAs seeking approval to market generic versions of UPTRAVI before expiration of certain Orange Book Listed Patents. The following entities are named defendants: Apotex Inc. and Apotex Corp. The following U.S. patents are included in one or more cases: 8,791,122; and 9,284,280. In April 2026, Actelion, Nippon Shinyaku Co. Ltd., Apotex Inc., and Apotex Corp. entered into a confidential settlement agreement resolving the action.

CARVYKTI

In January 2026, 2seventy bio, Inc. filed suit in the Unified Patent Court, Local Division of Brussels, against the Company, Janssen Biotech, Inc., Janssen Pharmaceuticals Inc., Janssen-Cilag International NV, Janssen Pharmaceutica NV, Janssen-Cilag NV, Janssen Biologics B.V., Janssen-Cilag B.V., Janssen-Cilag GmbH, Janssen-Cilag, Janssen-Cilag SpA, Janssen-Cilag A/S, Janssen-Cilag Aktiebolag, Janssen-Cilag Farmaceutica Lda., Legend Biotech Corporation, Legend Biotech USA Inc., Legend Biotech Ireland Limited, and Legend Biotech Belgium BV alleging that the manufacture and sale of CARVYKTI infringes EU Patent No. 3 689 383. In the suit, 2seventy bio, Inc. seeks damages and an injunction.

MedTech

In March 2016, Abiomed, Inc. filed a declaratory judgment action against Maquet Cardiovascular LLC (Maquet) in the United States District Court for the District of Massachusetts seeking a declaration that certain Impella products do not infringe Maquet patents. Maquet counterclaimed for infringement against Abiomed, Inc., Abiomed Europe GmbH, and Abiomed R&D, Inc. The following U.S. patents are at issue: 8,888,728; 9,327,068; 9,545,468; 9,561,314; and 9,597,437. In February 2026, the U.S. Court of Appeals for the Federal Circuit remanded the case after considering the District Court's claim constructions. Discovery will begin based on the altered constructions.

In November 2017, Maquet Cardiovascular LLC filed suit against Abiomed, Inc., Abiomed R&D, Inc., and Abiomed Europe GmbH in the United States District Court for the District of Massachusetts alleging that certain Impella products infringe Maquet patents. U.S. Patent No. 10,238,783 remains in the suit, and trial is scheduled to begin in May 2026.

Government proceedings

Like other companies in the pharmaceutical and medical technologies industries, the Company and certain of its subsidiaries are subject to extensive regulation by national, state, and local government agencies in the United States and other countries in which they operate. Such regulation has been the basis of government investigations and litigations. The most significant litigation brought by, and investigations conducted by, government agencies are listed below. It is possible that criminal charges and substantial fines and/or civil penalties or damages could result from government investigations or litigation.

MedTech

In July 2023, the DOJ issued Civil Investigative Demands to the Company, Johnson & Johnson Surgical Vision, Inc., and Johnson & Johnson Vision Care, Inc. (collectively, J&J Vision) in connection with a civil investigation under the False Claims Act relating to free or discounted intraocular lenses and equipment used in eye surgery, such as phacoemulsification and laser systems. J&J Vision has provided documents and information responsive to the Civil Investigative Demands and is continuing to cooperate with the DOJ regarding its inquiry. In the pending qui tam action, the Government filed a notice of declination, and the court ordered the complaint unsealed in February 2026. In March 2026, relators voluntarily dismissed their complaint without prejudice, and the court entered an order of dismissal.

Innovative Medicine

In July 2016, the Company and Janssen Products, LP were served with a qui tam complaint pursuant to the False Claims Act filed in the United States District Court for the District of New Jersey alleging the off-label promotion of two HIV products, PREZISTA and INTELENCE, and anti-kickback violations in connection with the promotion of these products. The complaint was filed under seal in December 2012. The federal and state governments have declined to intervene, and the lawsuit is being prosecuted by the relators. The Court denied summary judgment on all claims in December 2021. Daubert motions were granted in part and denied in part in January 2022, and trial commenced in May 2024. In June 2024, a jury found no liability regarding the anti-kickback violations but found liability for a portion of the off-label promotion claims. The Company challenged the verdict on the off-label claims in post-trial briefing. In March 2025, the court dismissed the state law portion of the claims but entered judgment on the federal claims. The Company appealed the remainder of the verdict to the Third Circuit. The federal government has intervened for the limited purpose of defending the qui tam provision of the False Claims Act. Briefing is complete and oral argument was held in March 2026. A decision is pending. In April 2026, the Third Circuit ordered the parties to engage in mediation.

In March 2017, Janssen Biotech, Inc. (JBI) received a Civil Investigative Demand from the United States Department of Justice (DOJ) regarding a False Claims Act investigation concerning management and advisory services provided to rheumatology and gastroenterology practices that purchased REMICADE or SIMPONI ARIA. In August 2019, the DOJ notified JBI that it was closing the investigation. Subsequently, the United States District Court for the District of Massachusetts unsealed a qui tam False Claims Act complaint, which was served on the Company. The DOJ had declined to intervene in the qui tam lawsuit in August 2019. The Company filed a motion to dismiss, which was granted in part and denied in part. The Court will hear argument on the parties’ summary judgment motions in May 2026. The Court has scheduled a trial date in November 2026.

General litigation

The Company or its subsidiaries regularly face claims in legal proceedings related to contracts, trade secrets, antitrust, unfair competition, consumer protection, and environmental issues, the most significant of which are listed below. Although the Company and its subsidiaries believe that they have substantial defenses to these cases, there can be no assurance as to the outcome of these matters. A loss in any of these cases could require the payment of damages, injunctions, and/or other relief.

In October 2017, certain United States service members and their families brought a complaint against a number of pharmaceutical and medical devices companies, including the Company and certain of its subsidiaries in the United States District Court for the District of Columbia, alleging that the defendants violated the United States Anti-Terrorism Act. The complaint alleges that the defendants provided funding for terrorist organizations through their sales practices pursuant to pharmaceutical and medical device contracts with the Iraqi Ministry of Health. In July 2020, the District Court dismissed the complaint. In January 2022, the United States Court of Appeals for the District of Columbia Circuit reversed the District Court’s decision. In June 2024, the

Supreme Court vacated the D.C. Circuit's decision and remanded the case to the D.C. Circuit for reconsideration. In January 2026, the D.C. Circuit affirmed its reversal of the District Court's dismissal of the complaint. In February 2026, the defendants sought rehearing en banc with the D.C. Circuit.

In February 2024, a putative class action was filed against the Company and the Pension & Benefits Committee of Johnson & Johnson in the United States District Court for the District of New Jersey. The complaint alleges that defendants breached fiduciary duties under the Employee Retirement Income Security Act (ERISA) by allegedly mismanaging the Company’s prescription-drug benefits program. The complaint seeks damages and other relief. In March 2025, plaintiffs filed a second amended complaint. In November 2025, the court granted defendants' motion to dismiss plaintiffs' fiduciary duty claims. Plaintiffs voluntarily withdrew their remaining claim, and the court entered final judgment in defendants' favor in January 2026. Plaintiffs have appealed to the United States Court of Appeals for the Third Circuit.

MedTech

In October 2020, Fortis Advisors LLC, in its capacity as representative of the former stockholders of Auris Health Inc. (Auris), filed a complaint against the Company, Ethicon Inc., and certain named officers and employees (collectively, Ethicon) in the Court of Chancery of the State of Delaware. The complaint alleges breach of contract, fraud, and other causes of action against Ethicon in connection with Ethicon’s acquisition of Auris in 2019. The complaint seeks damages and other relief. In December 2021, the court granted in part and denied in part defendants’ motion to dismiss certain causes of action. All claims against the individual defendants were dismissed. Trial occurred in January 2024. In September 2024, the court found liability with respect to certain claims and no liability with respect to other claims. In January 2026, the Delaware Supreme Court reversed in part and affirmed in part the Chancery Court's decision, including a $ 0.8  billion judgment, inclusive of interest, against the Company that was accrued in the fiscal fourth quarter of 2025 and subsequently paid in January 2026.

In October 2019, Innovative Health, LLC filed a complaint against Biosense Webster, Inc. (BWI) in the United States District Court for the Central District of California. The complaint alleges that certain of BWI's business practices and contractual terms violate the antitrust laws of the United States and the State of California by restricting competition in the sale of High Density Mapping Catheters and Ultrasound Catheters. In May 2025, a jury returned its verdict in favor of Innovative Health. In August 2025, the court issued a permanent injunction concerning BWI's business practices. BWI appealed both the jury verdict and the permanent injunction. In February 2026, BWI filed its opening brief.

Innovative Medicine

In October 2018, two separate putative class actions were filed against Actelion Pharmaceuticals Ltd., Actelion Pharmaceuticals US, Inc. and Actelion Clinical Research, Inc. (collectively, Actelion) in the United States District Court for the District of Maryland and the United States District Court for the District of Columbia. The complaints allege that Actelion violated state and federal antitrust and unfair competition laws by allegedly refusing to supply generic pharmaceutical manufacturers with samples of TRACLEER. TRACLEER is subject to a Risk Evaluation and Mitigation Strategy required by the U.S. Food and Drug Administration, which imposes restrictions on distribution of the product. In January 2019, the plaintiffs dismissed the District of Columbia case and filed a consolidated complaint in the United States District Court for the District of Maryland. In September 2024, the district court granted plaintiffs' motion for class certification. In February 2026, the parties agreed to settle the matter, which is pending court approval.

In December 2023, a putative class action lawsuit was filed against the Company and Janssen Biotech Inc. (collectively, Janssen) in the United States District Court for the Eastern District of Virginia. The complaint alleges that Janssen violated federal and state antitrust laws and other state laws by delaying biosimilar competition with STELARA through Janssen's enforcement of patent rights covering STELARA. The complaint seeks damages and other relief. In August 2024, the court granted in part and denied in part Janssen's motion to dismiss plaintiffs' amended complaint. In December 2025, the court granted plaintiffs' motion for class certification. In January 2026, the court granted summary judgment for Janssen on plaintiffs' claim regarding patents obtained through the acquisition of Momenta Pharmaceuticals, Inc. in 2020.

In December 2018, Janssen Biotech, Inc., Janssen Oncology, Inc., Janssen Research & Development, LLC, and the Company (collectively, Janssen) were served with a qui tam complaint on behalf of the United States, certain states, and the District of Columbia. The complaint alleges that Janssen violated the federal False Claims Act and state law when providing pricing information for ZYTIGA to the government in connection with direct sales and reimbursement programs. At this time, the federal and state governments have declined to intervene. In December 2021, the United States District Court for the District of New Jersey denied Janssen's motion to dismiss. Daubert briefing is ongoing.

In August 2025, Xoma Corporation (Xoma) filed a complaint against Janssen Biotech, Inc. (Janssen) in the United States District Court for the Eastern District of Pennsylvania. The complaint alleges breach of contract, unjust enrichment, and declaratory relief claims against Janssen regarding the alleged failure to obtain a license from Xoma in connection with Janssen's commercialization of TREMFYA. In December 2025, the court denied Janssen's motion to dismiss.

Note 12 — Restructuring

In fiscal 2025, the Company initiated a restructuring program of its Surgery franchise within the MedTech segment to simplify and focus operations by exiting certain non-strategic product lines and optimize select sites across the network. The pre-tax restructuring expense in the fiscal first quarter of 2026 primarily included costs related to product exits. Total project costs of approximately $ 0.3  billion have been recorded since the restructuring was announced. The estimated costs of the total program are between $ 0.9  billion - $ 1.0  billion and is expected to be substantially completed by the end of fiscal year 2026.

In fiscal 2023, the Company initiated a restructuring program of its Orthopaedics franchise within its MedTech segment to streamline operations by exiting certain markets, product lines and distribution network arrangements. The pre-tax restructuring expense in the fiscal first quarter of 2026 primarily included costs related to market and product exits. The pre-tax restructuring expense in the fiscal first quarter of 2025 primarily included costs related to asset impairments as well as market and product exits. Total project costs of approximately $ 0.8  billion have been recorded since the restructuring was announced and the program was substantially completed in the fiscal year 2025.

The following table summarizes the restructuring expenses for 2026 and 2025:

(Pre-tax Dollars in Millions) Q1 2026 Q1 2025

MedTech Segment Surgery franchise (1)

$ 55

MedTech Segment Orthopaedics franchise (2)

7

55

Total Programs

$ 62

55

(1) Included $ 30  million in Restructuring, $ 20  million in Cost of products sold and $ 5  million in Other (Income)/Expense on the Consolidated Statement of Earnings in the fiscal first quarter of 2026.

(2) Included $ 17  million in Restructuring, $ 8  million in Cost of products sold and $ 30  million in Other (Income)/Expense on the Consolidated Statement of Earnings in the fiscal first quarter of 2025.

Restructuring reserves as of March 29, 2026 and December 28, 2025 were insignificant.

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Item 2 — Management’s discussion and analysis of financial condition and results of operations

Results of operations

Sales to customers

Analysis of consolidated sales

For the fiscal first quarter of 2026, worldwide sales were $24.1 billion, a total increase of 9.9%, which included operational* growth of 6.4% and a positive currency impact of 3.5% as compared to 2025 fiscal first quarter sales of $21.9 billion. In the fiscal first quarter of 2026, the net impact of acquisitions and divestitures on worldwide operational sales growth was a positive 1.1%, primarily related to CAPLYTA. In the fiscal first quarter of 2026, the negative impact of the STELARA sales decline, due to biosimilar competition, on worldwide operational sales was approximately 5.4%.

Sales by U.S. companies were $13.3 billion in the fiscal first quarter of 2026, which represented an increase of 8.3% as compared to the prior year. In the fiscal first quarter of 2026, the net impact of acquisitions and divestitures on U.S. operational sales growth was a positive 2.1%. In the fiscal first quarter of 2026, the negative impact of the STELARA sales decline, due to biosimilar competition on U.S. operational sales was approximately 7.5%. Sales by international companies were $10.7 billion, a total increase of 11.9%, which included operational growth of 3.9% and a positive currency impact of 8.0%. In the fiscal first quarter of 2026, the net impact of acquisitions and divestitures on international operational sales growth was a negative 0.1%. In the fiscal first quarter of 2026, the negative impact of the STELARA sales decline, due to biosimilar competition, on international operational sales was approximately 3.0%.

In the fiscal first quarter of 2026, sales by companies in Europe achieved growth of 14.5%, which included operational growth of 2.7% and a positive currency impact of 11.8%. Sales by companies in the Western Hemisphere, excluding the U.S., achieved growth of 10.8%, which included operational growth of 2.5% and a positive currency impact of 8.3%. Sales by companies in the Asia-Pacific, Africa region achieved growth of 8.5%, which included operational growth of 6.1% and a positive currency impact of 2.4%.

Q1 2026

Sales by Geographic Region (in billions)

Q1 2026

Sales by Segment (in billions)

Note: values may have been rounded

*operational excludes the effect of translational currency

Form 10-Q

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Analysis of sales by business segments

Innovative Medicine

Innovative Medicine segment sales in the fiscal first quarter of 2026 were $15.4 billion, an increase of 11.2% as compared to the same period a year ago, including an operational increase of 7.4% and a positive currency impact of 3.8%. U.S. Innovative Medicine sales increased 9.6% as compared to the same period a year ago. International Innovative Medicine sales increased by 13.4%, including an operational increase of 4.3% and a positive currency impact of 9.1%. In the fiscal first quarter of 2026, the net impact of acquisitions and divestitures on the worldwide Innovative Medicine segment operational sales growth was a positive 1.8%, primarily related to CAPLYTA. In the fiscal first quarter of 2026, the negative impact of the STELARA sales decline, due to biosimilar competition, was an approximate 9.2%, 12.0% and 5.3% on worldwide, U.S. and international Innovative Medicine segment operational sales, respectively.

Major Innovative Medicine therapeutic area sales — Fiscal First Quarter Ended

(Dollars in Millions) March 29, 2026 March 30, 2025 Total

Change Operations

Change Currency

Change

Oncology

$6,973 $5,678 22.8   % 17.8   % 5.0   %

DARZALEX

3,964 3,237 22.5  17.8  4.7

CARVYKTI

597 369 62.1  57.4  4.7

TECVAYLI

202 151 33.5  30.1  3.4

TALVEY

152 86 76.7  72.8  3.9

RYBREVANT/ LAZCLUZE

257 141 82.7 80.5 2.2

ERLEADA

949 771 23.1  16.2  6.9

IMBRUVICA

660 709 (6.9) (13.9) 7.0

Other Oncology (1)

192 214 (10.6) (12.5) 1.9

Immunology

3,380 3,707 (8.8) (11.8) 3.0

TREMFYA

1,608 956 68.3  63.8  4.5

SIMPONI/ SIMPONI ARIA

647 659 (1.7) (5.7) 4.0

REMICADE

422 467 (9.5) (11.2) 1.7

STELARA

656 1,625 (59.7) (61.7) 2.0

Other Immunology

46 1 *

Neuroscience

2,175 1,647 32.0   29.3   2.7

SPRAVATO

468 320 46.4  44.5  1.9

CAPLYTA (2)

270 —

INVEGA SUSTENNA/ XEPLION/ INVEGA TRINZA/ TREVICTA

1,038 903 15.0  13.2  1.8

CONCERTA/ methylphenidate

136 148 (8.0) (11.7) 3.7

Other Neuroscience

262 277 (5.4) (11.3) 5.9

Pulmonary Hypertension (PH)

1,135 1,025 10.7   8.7   2.0

UPTRAVI

483 451 7.1  5.4  1.7

OPSUMIT/ OPSYNVI

606 522 16.1  14.0  2.1

Other Pulmonary Hypertension

46 52 (12.1) (14.5) 2.4

Infectious Diseases (ID)

889 802 10.8   4.1   6.7

EDURANT/rilpivirine

409 358 14.1  2.8  11.3

PREZISTA/ PREZCOBIX/ REZOLSTA/ SYMTUZA

443 403 10.0  7.4  2.6

Other Infectious Diseases

37 41 (10.4) (16.5) 6.1

Cardiovascular / Metabolism / Other (CVM)

876 1,013 (13.6) (14.7) 1.1

XARELTO

642 690 (7.0) (7.0) —

Other

233 323 (27.8) (31.2) 3.4

Total Innovative Medicine Sales

$15,426 $13,873 11.2 % 7.4 % 3.8   %

*percentage greater than 100% or not meaningful

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(1) Includes sales of ZYTIGA which were previously disclosed separately

(2) Acquired with Intra-Cellular Therapies on April 2, 2025

Oncology products achieved operational sales growth of 17.8% as compared to the same period a year ago. Contributors to the growth were: DARZALEX (daratumumab) driven by strong share gains and market growth partially offset by inventory dynamics, CARVYKTI (ciltacabtagene autoleucel) driven by continued share gains and site expansion, TECVAYLI (teclistamab-cqyv) driven by launch uptake and share gains from expansion in the community setting and recent U.S. TECVAYLI + DARZALEX FASPRO approval, TALVEY (talquetamab-tgvs) driven by share gains from expansion in the community setting, RYBREVANT (amivantamab)/LAZCLUZE (lazertinib) driven by launch uptake and share gains and ERLEADA (apalutamide) due to continued share gains and market growth. Growth was partially offset by IMBRUVICA (ibrutinib) share loss due to competitive pressures and unfavorable patient mix.

Immunology products experienced an operational decline of 11.8% as compared to the same period a year ago due to the sales decline of STELARA (ustekinumab) driven by the impact of biosimilar competition, increasing adoption of novel classes and unfavorable patient mix as well as declines of SIMPONI/SIMPONI ARIA and REMICADE (infliximab) driven by share loss, biosimilar competition, and unfavorable patient mix partially offset by market growth. The decline was partially offset by growth of TREMFYA (guselkumab) due to share gains across all indications with significant IBD launch momentum and market growth.

Biosimilars are pursuing regulatory approval for SIMPONI, which would likely result in a reduction in future sales, potentially in the first half of 2026 in Europe and second half of 2026 in the U.S.

Third parties have filed biologics license applications with the U.S. FDA, the European Medicines Agency, and other government authorities seeking approval to market biosimilar versions of STELARA around the globe. The Company expects continued launches of biosimilar versions of STELARA globally which will continue to negatively impact the Company’s sales of STELARA.

Neuroscience products, which include sales of CAPLYTA (lumateperone) acquired with the Intra-Cellular Therapies (Intra-Cellular) acquisition on April 2, 2025, achieved operational growth of 29.3% as compared to the same period a year ago. Growth of SPRAVATO (esketamine) was driven by continued increased physician and patient demand. Growth of INVEGA SUSTENNA / XEPLION / INVEGA TRINZA / TREVICTA was primarily driven by favorable patient mix.

Pulmonary Hypertension products achieved operational sales growth of 8.7% as compared to the same period a year ago. The sales growth of UPTRAVI (selexipag) was driven by market and share growth partially offset by inventory dynamics. The sales growth of OPSUMIT (macitentan)/OPSYNVI (macitentan/tadalafil) was driven by share gains, market growth and favorable patient mix. The Company expects generic competition for OPSUMIT in the U.S. in the second half of 2026, which would likely result in a reduction in future sales.

Infectious disease products achieved operational sales growth of 4.1% as compared to the same period a year ago. The sales growth of PREZISTA/ PREZCOBIX/ REZOLSTA/ SYMTUZA was driven by favorable patient mix.

Cardiovascular / Metabolism / Other products experienced a sales decline of 14.7% as compared to the same period a year ago. The sales decline of XARELTO (rivaroxaban) was primarily driven by continued share erosion.

The Company maintains a policy that no end customer will be permitted direct delivery of product to a location other than the billing location. This policy impacts contract pharmacy transactions involving non-grantee 340B covered entities for most of the Company’s drugs, subject to multiple exceptions. Both grantee and non-grantee covered entities can maintain certain contract pharmacy arrangements under policy exceptions. The Company has been and will continue to offer 340B discounts to covered entities on all of its covered outpatient drugs, and it believes its policy will improve its ability to identify inappropriate duplicate discounts and diversion prohibited by the 340B statute. The 340B Drug Pricing Program is a U.S. federal government program requiring drug manufacturers to provide significant discounts on covered outpatient drugs to covered entities.

Form 10-Q

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MedTech

MedTech segment sales in the fiscal first quarter of 2026 were $8.6 billion, an increase of 7.7% as compared to the same period a year ago, which included operational growth of 4.6% and a positive currency impact of 3.1%. U.S. MedTech sales increased by 5.9%. International MedTech sales increased by 9.7%, including operational growth of 3.2% and a positive currency impact of 6.5%. In the fiscal first quarter of 2026, the impact of divestitures on the MedTech segment operational sales growth was a negative 0.1%.

Major MedTech franchise sales — Fiscal First Quarter Ended

(Dollars in Millions) March 29, 2026 March 30, 2025 Total

Change Operations

Change Currency

Change

Cardiovascular

$2,377 $2,103 13.0   % 10.5 % 2.5   %

Electrophysiology

1,489 1,323 12.6  9.5  3.1

Abiomed

488 420 16.3  14.4  1.9

Shockwave

305 258 18.5 18.1 0.4

Other Cardiovascular

94 103 (9.1) (11.9) 2.8

Surgery

2,511 2,396 4.8   1.2   3.6

Advanced

1,123 1,073 4.6  1.2  3.4

General

1,388 1,323 4.9  1.1  3.8

Vision

1,365 1,279 6.7   3.6   3.1

Contact Lenses/Other

969 919 5.5  2.7  2.8

Surgical

396 361 9.7  6.0  3.7

Orthopaedics

2,383 2,241 6.3   3.2   3.1

Hips

436 409 6.5  3.5  3.0

Knees

420 389 7.9  4.6  3.3

Trauma

833 772 8.0  5.0  3.0

Spine, Sports & Other

694

671

3.5  0.2  3.3

Total MedTech Sales

$8,636 $8,020 7.7 % 4.6 % 3.1   %

The Cardiovascular franchise achieved operational sales growth of 10.5% as compared to the prior year fiscal first quarter. Electrophysiology sales growth was driven by procedure growth, commercial execution, new product performance (VARIPULSE, TRUPULSE, NUVISION and CRYSTAL) and inventory dynamics outside the U.S. partially offset by competitive pressures in Pulsed Field Ablation catheters. Abiomed sales growth was driven by the continued strong adoption of Impella 5.5 and Impella CP. Shockwave sales growth was driven by strong adoption of Coronary and Peripheral portfolios and new product launches.

The Surgery franchise achieved operational sales growth of 1.2% as compared to the prior year fiscal first quarter. The operational growth in Advanced Surgery was primarily due to the strength of the portfolio and commercial execution in Biosurgery and new product launches in Energy. This was partially offset by China volume-based procurement across all platforms and competitive pressures in Endocutters. The operational growth in General Surgery was primarily driven by technology penetration and upgrades within the differentiated Wound Closure portfolio coupled with market expansion partially offset by timing of tenders outside the U.S.

The Vision franchise achieved operational sales growth of 3.6% as compared to the prior year fiscal first quarter. The Contact Lenses/Other operational growth was driven by strong performance in the ACUVUE OASYS 1-Day family of products and strategic price actions partially offset by inventory dynamics outside the U.S. The Surgical operational growth was primarily driven by the strength of recent product innovations, robust demand and strong commercial execution partially offset by competitive pressures in the U.S.

The Orthopaedics franchise achieved operational sales growth of 3.2% as compared to the prior year fiscal first quarter. The operational growth in Hips was due to new product launches. The operational growth in Knees was driven by the strength of the ATTUNE portfolio and pull through related to the VELYS Robotic assisted solutions. The operational growth in Trauma was primarily driven by recently launched products. The operational growth in Spine, Sports & Other was driven by new product innovations and growth in shoulders partially offset by competitive pressures and inventory dynamics.

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In October 2025, the Company announced its intention to separate its Orthopaedics business. The Company continues to explore multiple paths to effect the planned separation with a targeted completion within 18 to 24 months after the initial announcement.

Analysis of consolidated earnings before provision for taxes on income

Consolidated earnings before provision for taxes on income for the fiscal first quarter of 2026 was $6.0 billion representing 24.9% of sales as compared to $13.6 billion in the fiscal first quarter of 2025, representing 62.3% of sales. The fiscal first quarter of 2025 includes approximately $7.0 billion related to the talc reserve reversal.

Cost of products sold

(Dollars in billions. Percentages in chart are as a percent to total sales)

Q1 2026 versus Q1 2025

Cost of products sold increased slightly as a percent to sales primarily driven by:

• Tariffs and other operational drivers in the MedTech business

• Unfavorable product mix primarily driven by the decline of STELARA sales in the Innovative Medicine business

partially offset by

• Favorable translational currency in the Innovative Medicine business

The intangible asset amortization expense included in cost of products sold for the fiscal first quarters of 2026 and 2025 was $1.2 billion and $1.1 billion, respectively.

Selling, marketing and administrative expenses

(Dollars in billions. Percentages in chart are as a percent to total sales)

Q1 2026 versus Q1 2025

Selling, Marketing and Administrative Expenses increased as a percent to sales primarily driven by:

Form 10-Q

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• Phasing of advertising expense and increased investment related to TREMFYA and the acquisition of Intra-Cellular (CAPLYTA) in the Innovative Medicine business

Research and development expense

Research and development expense by segment of business was as follows:

Fiscal First Quarter Ended

2026 2025

(Dollars in Millions) Amount % of Sales Amount % of Sales

Innovative Medicine $2,813 18.2 % $2,548  18.4 %

MedTech 714 8.3  677  8.4

Total research and development expense $3,527 14.7 % $3,225   14.7 %

Percent increase over the prior year 9.4 %

*As a percent to segment sales

Interest (income) expense

Interest (income) expense in the fiscal first quarter of 2026 was net expense of $43 million as compared to net income of $128 million in the fiscal first quarter of 2025. Interest income in the fiscal first quarter of 2026 decreased as compared to the prior year driven by a lower average cash balance. Interest expense in the fiscal first quarter of 2026 was higher as compared to the prior year due to a higher average debt balance. The balance of cash, cash equivalents and current marketable securities was $22.1 billion at the end of the fiscal first quarter of 2026 as compared to $38.8 billion at the end of the fiscal first quarter of 2025. The Company’s debt position was $55.0 billion as of March 29, 2026, as compared to $52.3 billion the same period a year ago.

Other (income) expense, net*

Q1 2026 versus Q1 2025

Other (income) expense, net for the fiscal first quarter of 2026 reflected a decrease in income of $7.6 billion as compared to the prior year primarily due to the following:

Fiscal First Quarter

(Dollars in Billions)(Income)/Expense March 29, 2026 March 30, 2025 Change

Litigation related (1)

$

0.3

(7.0)

7.3

Acquisition, Integration and Divestiture related

0.1 0.1  0.0

Orthopaedics separation

0.1 0.0  0.1

Employee benefit related

(0.2) (0.1) (0.1)

Other

0.0 (0.3) 0.3

Total Other (Income) Expense, Net

$ 0.3  (7.3) 7.6

(1) The fiscal first quarter of 2026 includes charges for talc matters of $0.3 billion. The fiscal first quarter of 2025 includes approximately $7.0 billion related to the talc reserve reversal. For additional details related to talc refer to Note 11 to the Consolidated Financial Statements.

*Other (income) expense, net is the account where the Company records gains and losses related to the sale and write-down of certain investments in equity securities held by Johnson & Johnson Innovation - JJDC, Inc. (JJDC), changes in the fair value of securities, gains and losses on divestitures, gains and losses on sale of assets, certain transactional currency gains and losses, acquisition-related costs, litigation accruals and settlements, investment (income)/loss related to employee benefit plans, as well as royalty income.

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Segment income before tax

Income before tax by segment of business for the fiscal first quarters were as follows:

Income Before Tax Segment Sales Percent of Segment Sales

(Dollars in Millions) March 29, 2026 March 30, 2025 March 29, 2026 March 30, 2025 March 29, 2026 March 30, 2025

Innovative Medicine $5,317 $5,210 $15,426 $13,873 34.5 % 37.6 %

MedTech 1,239 1,421 8,636 8,020 14.3  17.7

Segment total 6,556 6,631 24,062 21,893 27.2  30.3

(Income)/ Expenses not allocated to segments (1)

566 (7,000)

Earnings before provision for taxes on income $5,990 $13,631 $24,062 $21,893 24.9 % 62.3 %

(1) Amounts not allocated to segments include interest (income) expense, certain litigation expenses and general corporate (income) expense. The fiscal first quarter of 2026 includes charges of $0.3 billion related to talc matters. The fiscal first quarter of 2025 includes approximately $7.0 billion related to the talc reserve reversal. For additional details related to talc refer to Note 11 to the Consolidated Financial Statements.

Innovative Medicine segment

The Innovative Medicine segment income before tax as a percent of sales in the fiscal first quarter of 2026 was 34.5% versus 37.6% for the same period a year ago. The decrease in the income before tax as a percent of sales for the fiscal first quarter of 2026 as compared to the prior year was primarily driven by the following:

• Unfavorable product mix in Cost of products sold, primarily driven by the decline of STELARA sales

• Phasing of advertising expense and investment related to TREMFYA and to the acquisition of Intra-Cellular (CAPLYTA)

partially offset by

• Favorable translational currency

MedTech segment

The MedTech segment income before tax as a percent of sales in the fiscal first quarter of 2026 was 14.3% versus 17.7% for the same period a year ago. The decrease in the income before tax as a percent of sales for the fiscal first quarter of 2026 as compared to the prior year was primarily driven by the following:

• Tariffs included in Cost of products sold

• Gains on certain divestitures recorded in 2025

• Orthopaedics separation related costs

Restructuring

In fiscal 2025, the company initiated a restructuring program of its Surgery franchise within the MedTech segment to simplify and focus operations by exiting certain non-strategic product lines and optimize select sites across the network. The pre-tax restructuring expense was $55 million in the fiscal first quarter of 2026, of which $30 million was recorded in Restructuring, $20 million in Cost of products sold and $5 million in Other income and expense on the Consolidated Statement of Earnings. The pre-tax restructuring expense in the fiscal first quarter of 2026 primarily included costs related to product exits. Total project costs of approximately $0.3 billion have been recorded since the restructuring was announced. The estimated costs of the total program are between $0.9 billion - $1.0 billion and is expected to be substantially completed by the end of fiscal year 2026.

In fiscal 2023, the Company initiated a restructuring program of its Orthopaedics franchise within its MedTech segment to streamline operations by exiting certain markets, product lines and distribution network arrangements. The pre-tax restructuring expense was $55 million in the fiscal first quarter of 2025, of which $17 million was recorded in Restructuring, $30 million in Other (Income)/Expense and $8 million in Cost of products sold on the Consolidated Statement of Earnings primarily for costs related to asset impairments as well as market and product exits. Total project costs of approximately $0.8 billion have been recorded since the restructuring was announced and the program was substantially completed in the fiscal year 2025.

For further details related to the restructuring refer to Note 12 to the Consolidated Financial Statements.

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Provision for taxes on income

The worldwide effective income tax rate for the fiscal three months was 12.6% in 2026 and 19.3% in 2025.

On December 15, 2022, the European Union (EU) Member States formally adopted the EU’s Pillar Two Directive, which generally provides for a minimum effective tax rate of 15%, as established by the Organization for Economic Co-operation and Development (OECD) Pillar Two Framework that was supported by over 130 countries worldwide. Several EU and non-EU countries have enacted Pillar Two legislation with an initial effective date of January 1, 2024, with other aspects of the law effective in 2026 or later. While countries continue to enact new provisions or issue new regulations this could have an impact to the Company’s effective tax rate. The Company will continue to monitor further developments to determine any potential impact in the countries in which we operate, such as the recently issued administrative guidance on the side-by-side system that will fully exclude U.S. parented groups from certain provisions of the Pillar Two Framework.

For further details related to the fiscal 2026 provision for taxes refer to Note 5 to the Consolidated Financial Statements.

Liquidity and capital resources

Proceeds from the disposal of assets/businesses, net

Dividends to shareholders

Cash flows

Cash and cash equivalents were $21.7 billion at the end of the fiscal first quarter of 2026 as compared with $19.7 billion at the end of fiscal year 2025. The primary sources and uses of cash that contributed to the $2.0 billion increase were:

(Dollars In Billions)

19.7

Q4 2025 Cash and cash equivalents balance

2.5

net cash generated from operating activities

(1.0)

net cash used for investing activities

0.5

net cash from financing activities

$

21.7

Q1 2026 Cash and cash equivalents

In addition, the Company had $0.4 billion in marketable securities at the end of the fiscal first quarter of 2026 and $0.4 billion at the end of fiscal year 2025.

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Cash flow from operations of $2.5 billion was the result of:

(Dollars In Billions)

$

5.2

Net earnings

2.5

non-cash expenses and other adjustments primarily for depreciation and amortization, stock-based compensation, deferred tax provision and asset write-downs

(1.0)

an increase in accounts receivable and inventories

(3.9)

a decrease in accounts payable and accrued liabilities

0.3

a decrease in other current and non-current assets

(0.6)

a decrease in other current and non-current liabilities

$

2.5

Net cash flows from operations

Cash flow used for investing activities of $1.0 billion was primarily from:

(Dollars In Billions)

$

(1.0)

additions to property, plant and equipment

0.1

net sales of investments

(0.1)

Other and rounding

$

(1.0)

Net cash used for investing activities

Cash flow from financing activities of $0.5 billion was primarily from:

(Dollars In Billions)

$

(3.1)

dividends to shareholders

(4.0)

repurchase of common stock

7.2

net proceeds from short and long term debt

1.2

proceeds from stock options exercised/employee withholding tax on stock awards, net

(0.8)

Primarily Auris shareholder payment (described in Note 11), other and rounding

$

0.5

Net cash from financing activities

The Company has access to substantial sources of funds at numerous banks worldwide and has the ability to issue up to $20 billion in Commercial Paper. Furthermore, in June 2025, the Company secured a new 364-day Credit Facility of $10 billion (expiration on June 24, 2026) which may be used for general corporate purposes including to support our commercial paper borrowings. Interest charged on borrowings under the credit line agreement is based on either Secured Overnight Financing Rate (SOFR) Reference Rate or other applicable market rate as allowed plus applicable margins. Commitment fees under the agreement are not material.

As of March 29, 2026, the Company had cash, cash equivalents and marketable securities of approximately $22.1 billion and had approximately $55.0 billion of notes payable and long-term debt for a net debt position of $32.9 billion as compared to the prior year fiscal first quarter net debt position of $13.5 billion. The Company anticipates that operating cash flows, the ability to raise funds from external sources, borrowing capacity from existing committed credit facilities and access to the commercial paper markets will continue to provide sufficient resources to fund operating needs, including the Company’s remaining balance of approximately $3.4 billion related to talc matters, $1.8 billion related to the current portion of Corporate bonds due and the remaining approximately $1.1 billion related to opioid settlements. In addition, the Company monitors the global capital markets on an ongoing basis and from time to time may raise capital when market conditions are favorable.

Dividends

On January 2, 2026, the Board of Directors declared a regular cash dividend of $1.30 per share, payable on March 10, 2026, to shareholders of record as of February 24, 2026.

On April 14, 2026, the Board of Directors declared a regular cash dividend of $1.34 per share, payable on June 9, 2026, to shareholders of record as of May 26, 2026. The Company expects to continue the practice of paying regular quarterly cash dividends.

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Other information

New accounting pronouncements

Refer to Note 1 to the Consolidated Financial Statements for new accounting pronouncements.

Economic and market factors

In July 2023, Janssen Pharmaceuticals, Inc. (Janssen) filed litigation against the U.S. Department of Health and Human Services as well as the Centers for Medicare and Medicaid Services challenging the constitutionality of the IRA's Medicare Drug Price Negotiation Program. The litigation requests a declaration that the IRA violates Janssen’s rights under the First Amendment and the Fifth Amendment to the Constitution and therefore that Janssen is not subject to the IRA’s mandatory pricing scheme. While the impact of the IRA on our business and the broader pharmaceutical industry remains uncertain, as litigation filed by Janssen and other pharmaceutical companies remains ongoing, CMS has publicly announced the maximum fair price for each of the selected drugs and has recently begun implementing the program. In December 2025, Janssen sought review by the U.S. Supreme Court of the Third Circuit's majority affirmance of the district court’s ruling in favor of the government.

The Company operates in certain countries where the economic conditions continue to present significant challenges. The Company continues to monitor these situations and take appropriate actions. Inflation rates and currency exchange rates continue to have an effect on worldwide economies and, consequently, on the way the Company operates. The Company has accounted for operations in Venezuela, Argentina, Turkey and Egypt as highly inflationary, as the prior three-year cumulative inflation rate surpassed 100%. In the face of increasing costs, the Company strives to maintain its profit margins through cost reduction programs, productivity improvements and periodic price increases.

The long-term implications of regional conflicts on the Company are difficult to predict. The financial impact of known existing conflicts in the fiscal first quarter of 2026 was not material.

Governments around the world consider various proposals to make changes to tax laws, which may include increasing or decreasing existing statutory tax rates. In connection with various government initiatives, companies are required to disclose more information to tax authorities on operations around the world, which may lead to greater audit scrutiny of profits earned in other countries. A change in statutory tax rate in any country would result in the revaluation of the Company’s deferred tax assets and liabilities related to that particular jurisdiction in the period in which the new tax law is enacted. This change would result in an expense or benefit recorded to the Company’s Consolidated Statement of Earnings. The Company closely monitors these proposals as they arise in the countries where it operates. Changes to the statutory tax rate may occur at any time, and any related expense or benefit recorded may be material to the fiscal quarter and year in which the law change is enacted.

The Company may be further impacted by the imposition of tariffs, trade protection measures or other policies adopted by any jurisdiction that favor domestic companies and technologies over foreign competitors.

The Company faces various worldwide health care changes that may continue to result in pricing pressures that include health care cost containment and government legislation relating to sales, promotions and reimbursement of health care products.

Changes in the behavior and spending patterns of purchasers of healthcare products and services, including delaying medical procedures, rationing prescription medications, reducing the frequency of physician visits and foregoing healthcare insurance coverage, may continue to impact the Company’s businesses.

The Company faces regular intellectual property challenges from third parties, including generic and biosimilar manufacturers, seeking to manufacture and market generic and biosimilar versions of key pharmaceutical products prior to the expiration of the applicable patents. These challengers file Abbreviated New Drug Applications or abbreviated Biologics License Applications with the FDA or otherwise challenged the coverage and/or validity of the Company’s patents. In the event the Company is not successful in defending the patent claims challenged in the resulting lawsuits, generic or biosimilar versions of the products at issue may be introduced to the market, resulting in the potential for substantial market share and revenue losses for those products, and which may result in a non-cash impairment charge in any associated intangible asset. There is also risk that one or more competitors could launch a generic or biosimilar version of the product at issue following regulatory approval even though one or more valid patents are in place.

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Item 3 — Quantitative and qualitative disclosures about market risk

There has been no material change in the Company’s assessment of its sensitivity to market risk since its presentation set forth in Item 7A, “Quantitative and Qualitative Disclosures About Market Risk,” in its Annual Report on Form 10-K for the fiscal year ended December 28, 2025.

Item 4 — Controls and procedures

Disclosure controls and procedures. At the end of the period covered by this report, the Company evaluated the effectiveness of the design and operation of its disclosure controls and procedures. The Company’s disclosure controls and procedures are designed to ensure that information required to be disclosed by the Company in the reports that it files or submits under the Securities Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by the Company in the reports that it files or submits under the Securities Exchange Act is accumulated and communicated to the Company’s management, including its principal executive and principal financial officers, or persons performing similar functions, as appropriate, to allow timely decisions regarding required disclosure. Joaquin Duato, Chief Executive Officer; Chairman, Executive Committee and Joseph J. Wolk, Executive Vice President, Chief Financial Officer, reviewed and participated in this evaluation. Based on this evaluation, Messrs. Duato and Wolk concluded that, as of the end of the period covered by this report, the Company’s disclosure controls and procedures were effective.

Internal control. During the period covered by this report, there were no changes in the Company’s internal control over financial reporting that have materially affected, or are reasonably likely to materially affect, the Company’s internal control over financial reporting. The Company continues to monitor and assess the effectiveness of the design and operation of its disclosure controls and procedures.

The Company is implementing a multi-year, enterprise-wide initiative to integrate, simplify and standardize processes and systems for the human resources, information technology, procurement, supply chain and finance functions. These are enhancements to support the growth of the Company’s financial shared service capabilities and standardize financial systems. This initiative is not in response to any identified deficiency or weakness in the Company’s internal control over financial reporting. In response to this initiative, the Company has and will continue to align and streamline the design and operation of its financial control environment.

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Part II — Other information

Item 1 — Legal proceedings

The information called for by this item is incorporated herein by reference to Note 11 included in Part I, Item 1, Financial Statements (unaudited) — Notes to Consolidated Financial Statements.

Item 2 — Unregistered sales of equity securities and use of proceeds

(c) Purchases of Equity Securities by the Issuer and Affiliated Purchasers.

The following table provides information with respect to Common Stock purchases by the Company during the fiscal first quarter of 2026. Common stock purchases on the open market are made as part of a systematic plan to meet the needs of the Company's compensation programs. The repurchases below also include the stock-for-stock option exercises that settled in the fiscal first quarter.

Fiscal Month Period Total Number

of Shares

Purchased (1)

Avg. Price

Per Share Total Number of

Shares

Purchased as

Part of Publicly

Announced Plans

or Programs

Maximum Number of

Shares that May Yet

Be Purchased Under

the Plans or Programs

December 29, 2025 through January 25, 2026

649,607 219.26 — —

January 26, 2026 through February 22, 2026

8,626,168 236.70 — —

February 23, 2026 through March 29, 2026

7,558,445 243.91 — —

Total

16,834,220 239.26 — —

(1) During the fiscal first quarter of 2026, the Company repurchased an aggregate of 16,834,220 shares of Johnson & Johnson Common Stock in open-market transactions, all of which were purchased as part of a systematic plan to meet the needs of the Company’s compensation programs.

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Item 5 — Other information

Securities trading plans of Directors and Executive Officers . During the fiscal first quarter of 2026, none of our directors or officers (as defined in Rule 16a-1(f) of the Exchange Act) informed us of the adoption or termination of a “Rule 10b5-1 trading arrangement” or “non-Rule 10b5-1 trading arrangement,” each as defined in Item 408 of Regulation S-K.

Item 6 — Exhibits

Exhibit 31.1 Certification of Chief Executive Officer under Rule 13a-14(a) of the Securities Exchange Act pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 — Filed with this document.

Exhibit 31.2 Certification of Chief Financial Officer under Rule 13a-14(a) of the Securities Exchange Act pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 — Filed with this document.

Exhibit 32.1 Certification of Chief Executive Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 — Furnished with this document.

Exhibit 32.2 Certification of Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 — Furnished with this document.

Exhibit 101:

EX-101.INS

Instance Document - the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document

EX-101.SCH

Inline XBRL Taxonomy Extension Schema

EX-101.CAL

Inline XBRL Taxonomy Extension Calculation Linkbase

EX-101.LAB

Inline XBRL Taxonomy Extension Label Linkbase

EX-101.PRE

Inline XBRL Taxonomy Extension Presentation Linkbase

EX-101.DEF

Inline XBRL Taxonomy Extension Definition Document

Exhibit 104:

Cover Page Interactive Data File––the cover page interactive data file does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document.

Form 10-Q

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Signatures

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

Date: April 22, 2026

Date: April 22, 2026

JOHNSON & JOHNSON

(Registrant)

By

/s/ J. J. Wolk

J. J. Wolk , Executive Vice President, Chief Financial Officer (Principal Financial Officer)

By

/s/  R. J. Decker Jr.

R. J. Decker Jr. , Controller (Principal Accounting Officer)

40

打开原文

吉利德增长与并购压力

重要性4/5 中高

一手10-Q直接覆盖GILD核心产品、盈利、并购费用与流动性;披露距日报约两个月,需结合后续季度数据阅读。

中文摘要

核心结论

Gilead Sciences(吉利德科学,GILD)2026年第一季度营收69.60亿美元,同比增长4%;HIV(人类免疫缺陷病毒)产品增长和Trodelvy肿瘤药放量支撑收入,Veklury与细胞治疗下滑形成拖累。公司同时预计近期收购将在2026年第二季度形成约115亿美元在研研发费用,二季度和全年可能录得净亏损,利润表波动将显著上升。

重要性评级

评级:4/5(中高)。这是公司向美国证券交易委员会提交的2026年第一季度10-Q文件,直接覆盖GILD的产品、利润、并购费用与现金流;披露日为05/07(未给出具体时刻),对07/11日报属于较新的公司基本面材料,但不含第二季度实际业绩。

关键事实

  • 2026年第一季度总营收69.60亿美元,上年同期66.67亿美元;产品销售69.46亿美元,同比增长5%。
  • 净利润20.21亿美元,同比增长54%;稀释后每股收益1.61美元,上年同期为1.04美元。公司称增长还受权益证券未实现收益、较低已收购在研研发费用影响。
  • HIV产品销售50.30亿美元,同比增长10%;Biktarvy销售33.61亿美元,同比增长7%,Descovy销售8.07亿美元,同比增长38%,新产品Yeztugo销售1.66亿美元。
  • 肿瘤药Trodelvy销售4.02亿美元,同比增长37%;细胞治疗销售4.07亿美元,同比下降12%,公司归因于持续竞争压力下的需求下降。
  • Veklury销售1.44亿美元,同比下降52%,公司归因于与新冠相关的住院率下降;肝病产品销售7.67亿美元,同比增长1%。
  • 产品毛利率79.2%,较上年同期提高249个基点;销售、一般及管理费用14.51亿美元,同比增长15%。
  • 公司预计近期已完成或已宣布收购将在2026年第二季度确认约115亿美元已收购在研研发费用,并预期二季度及2026年全年净亏损。
  • 截至03/31,现金及现金等价物76亿美元、可交易债务证券9.97亿美元;4月取得11亿美元定期贷款借款。

作者观点与证据

文件为公司向美国证券交易委员会提交的法定财务披露,产品销售、利润、费用与流动性数据具有一手证据属性。管理层将收入增长归因于HIV产品、Trodelvy和Livdelzi,并披露Veklury、慢性丙型肝炎及细胞治疗的销售压力;收购费用与全年亏损预期属于前瞻性陈述,受交易交割、监管条件、研发估值及后续经营结果影响。

与相关标的的关系

GILD的收入基础仍由HIV组合主导,Biktarvy和Descovy的增长直接影响核心销售规模。Trodelvy增长、Livdelzi需求与毛利率改善提供增量信息;细胞治疗、Veklury及丙肝产品的下滑显示部分业务线仍有需求或竞争压力。约115亿美元的在研研发费用将直接影响GILD短期报告利润,不能与经常性经营表现等同。

时效性与限制

文件发布于05/07(未给出具体时刻),检索于美东时间07/11 07:43(UTC+8 07/11 19:43)。数据截至03/31,未包含第二季度实际销售、收购最终会计处理或后续临床和监管结果。原文为公司自述的10-Q披露,产品增长归因与前瞻性判断需结合后续财报、监管文件和临床数据核验。

后续跟踪

  • 第二季度实际确认的收购相关在研研发费用、交易交割状态及对全年净利润的影响。
  • Biktarvy、Descovy与Yeztugo的销量、价格和库存变化。
  • Trodelvy增长能否延续,以及细胞治疗销售与竞争格局的变化。
  • Veklury、丙肝产品下滑幅度,以及现金、债务和经营现金流在并购后的变化。
原文
Gilead Sciences Quarterly Report for the Quarter Ended March 31, 2026

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 10-Q

☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended March 31, 2026

or

☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from ______ to ______

Commission File No. 000-19731

GILEAD SCIENCES, INC.

(Exact Name of Registrant as Specified in Its Charter)

Delaware 94-3047598

(State or Other Jurisdiction of Incorporation or Organization) (IRS Employer Identification No.)

333 Lakeside Drive , Foster City , California 94404

(Address of principal executive offices) (Zip Code)

650 - 574-3000

(Registrant’s Telephone Number, Including Area Code)

Securities registered pursuant to Section 12(b) of the Act:

Title of each class Trading Symbol(s) Name of each exchange on which registered

Common Stock, par value, $0.001 per share GILD The Nasdaq Global Select Market

Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.     Yes x      No ¨

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).     Yes x      No ¨

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer” “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer x Accelerated filer ¨ Non-accelerated filer ¨

Smaller reporting company ☐ Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).

Yes ☐      No x

Number of shares outstanding of the issuer’s common stock, par value $0.001 per share, as of April 30, 2026: 1,241,569,874

GILEAD SCIENCES, INC.

INDEX

PART I.

FINANCIAL INFORMATION

3

Item 1.

Condensed Consolidated Financial Statements

3

Condensed Consolidated Balance Sheets

3

Condensed Consolidated Statements of Operations

4

Condensed Consolidated Statements of Comprehensive Income

5

Condensed Consolidated Statements of Stockholders’ Equity

6

Condensed Consolidated Statements of Cash Flows

7

Notes to Condensed Consolidated Financial Statements

8

Item 2.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

24

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

31

Item 4.

Controls and Procedures

31

PART II.

OTHER INFORMATION

32

Item 1.

Legal Proceedings

32

Item 1A.

Risk Factors

32

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

46

Item 3.

Defaults Upon Senior Securities

46

Item 4.

Mine Safety Disclosures

46

Item 5.

Other Information

46

Item 6.

Exhibits

46

SIGNATURES

51

We own or have rights to various trademarks, copyrights and trade names used in our business, including the following: GILEAD ® , GILEAD SCIENCES ® , KITE ® , AMBISOME ® , ATRIPLA ® , BIKTARVY ® , CAYSTON ® , COMPLERA ® , DESCOVY ® , DESCOVY FOR PREP ® , EMTRIVA ® , EPCLUSA ® , EVIPLERA ® , GENVOYA ® , HARVONI ® , HEPCLUDEX ® , HEPSERA ® , JYSELECA ® , LETAIRIS ® , LIVDELZI ® /LYVDELZI ® , ODEFSEY ® , SOVALDI ® , STRIBILD ® , SUNLENCA ® , TECARTUS ® , TRODELVY ® , TRUVADA ® , TRUVADA FOR PREP ® , TYBOST ® , VEKLURY ® , VEMLIDY ® , VIREAD ® , VOSEVI ® , YESCARTA ® , YEZTUGO ® /YEYTUO ® and ZYDELIG ® . Other trademarks and trade names are the property of their respective owners.

Certain amounts and percentages in this Quarterly Report on Form 10-Q may not sum or recalculate due to rounding.

This Quarterly Report on Form 10-Q, including Part I, Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations and Part II, Item 1A. Risk Factors, contains forward-looking statements regarding future events and our future results that are subject to the safe harbors created under the Securities Act of 1933, as amended, and the Securities Exchange Act of 1934, as amended. Words such as “ambition,” “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “forecast,” “goal,” “hope,” “intend,” “may,” “might,” “outlook,” “plan,” “priority,” “project,” “seek,” “should,” “target” and variations of such words and similar expressions are intended to identify such forward-looking statements. In addition, any statements other than statements of historical fact are forward-looking statements, including statements regarding overall trends; operating cost, product sales and revenue trends; liquidity and capital needs; plans and expectations with respect to products, product candidates, corporate strategy, business and operations, financial projections, strategic investments and the use of capital; expectations regarding the impact of the Inflation Reduction Act and the One Big Beautiful Bill Act, changes in U.S. regulatory policies, changes in U.S. trade policies, including tariffs, and U.S. government shutdowns; collaboration and licensing arrangements; patent protection and estimated loss of exclusivity for our products and product candidates; ongoing litigation and investigation matters; and other statements of expectations, beliefs, future plans and strategies, anticipated events or trends and similar expressions.

We have based these forward-looking statements on our current expectations about future events. These statements are not guarantees of future performance and involve risks, uncertainties and assumptions that are difficult to predict. Our actual results or outcomes may differ materially from those suggested by these forward-looking statements for various reasons, including those identified in Part II, Item 1A. Risk Factors of this Quarterly Report on Form 10-Q. Given these risks and uncertainties, you are cautioned not to place undue reliance on forward-looking statements. The forward-looking statements included in this report are made only as of the date hereof unless otherwise specified. Except as required under federal securities laws and the rules and regulations of U.S. Securities and Exchange Commission, we do not undertake, and specifically decline, any obligation to update any of these statements or to publicly announce the results of any revisions to any forward-looking statements after the distribution of this report, whether as a result of new information, future events, changes in assumptions or otherwise. In evaluating our business, you should carefully consider the risks described under Part II, Item 1A. Risk Factors of this Quarterly Report on Form 10-Q. Any of the risks contained herein could materially and adversely affect our business, results of operations and financial condition.

2

PART I.    FINANCIAL INFORMATION

Item 1.    CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

GILEAD SCIENCES, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(unaudited)

(in millions, except per share amounts) March 31, 2026 December 31, 2025

Assets

Current assets:

Cash and cash equivalents $ 7,628   $ 7,564

Short-term marketable debt securities 15   68

Accounts receivable, net 4,741   4,913

Inventories 1,914   1,774

Prepaid and other current assets 4,342   4,024

Total current assets 18,641   18,342

Property, plant and equipment, net 5,638   5,606

Long-term marketable debt securities 983   2,974

Intangible assets, net 16,382   16,978

Goodwill 8,314   8,314

Deferred tax assets 1,767   1,964

Other long-term assets 4,554   4,845

Total assets $ 56,278   $ 59,023

Liabilities and Stockholders’ Equity

Current liabilities:

Accounts payable $ 645   $ 715

Accrued rebates 4,118   4,337

Current portion of long-term debt, net 1,313   2,807

Other current liabilities 3,399   3,953

Total current liabilities 9,476   11,813

Long-term debt, net 20,861   22,129

Long-term income taxes payable 918   896

Deferred tax liabilities 392   402

Other long-term liabilities 1,200   1,165

Commitments and contingencies (Note 10)

Stockholders’ equity:

Preferred stock, par value $ 0.001 per share; 5 shares authorized; no ne outstanding

—   —

Common stock, par value $ 0.001 per share; 5,600 shares authorized; 1,242 and 1,241 shares issued and outstanding, respectively

1   1

Additional paid-in capital 9,305   8,932

Accumulated other comprehensive income 78   39

Retained earnings 14,131   13,730

Total Gilead stockholders’ equity 23,515   22,703

Noncontrolling interest ( 84 ) ( 84 )

Total stockholders’ equity 23,431   22,618

Total liabilities and stockholders’ equity $ 56,278   $ 59,023

See accompanying notes.

3

GILEAD SCIENCES, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(unaudited)

Three Months Ended

March 31,

(in millions, except per share amounts) 2026 2025

Revenues:

Product sales $ 6,946   $ 6,613

Royalty, contract and other revenues 14   54

Total revenues 6,960   6,667

Costs and expenses:

Cost of goods sold 1,445   1,540

Research and development expenses 1,372   1,379

Acquired in-process research and development expenses 107   253

Selling, general and administrative expenses 1,451   1,258

Total costs and expenses 4,374   4,430

Operating income 2,586   2,237

Interest expense 240   260

Other (income) expense, net ( 235 ) 328

Income before income taxes 2,580   1,649

Income tax expense 559   334

Net income $ 2,021   $ 1,315

Basic earnings per share $ 1.63   $ 1.06

Diluted earnings per share $ 1.61   $ 1.04

Shares used in basic earnings per share calculation 1,242   1,246

Shares used in diluted earnings per share calculation 1,254   1,259

See accompanying notes.

4

GILEAD SCIENCES, INC.

CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME

(unaudited)

Three Months Ended

March 31,

(in millions) 2026 2025

Net income $ 2,021   $ 1,315

Other comprehensive income (loss), net of reclassifications and taxes:

Net (loss) gain on foreign currency translation ( 10 ) 18

Net loss on available-for-sale debt securities ( 12 ) —

Net gain (loss) on cash flow hedges 61   ( 58 )

Other comprehensive income (loss), net 39   ( 40 )

Comprehensive income, net $ 2,060   $ 1,275

See accompanying notes.

5

GILEAD SCIENCES, INC.

CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY

(unaudited)

Three Months Ended March 31, 2026

(in millions, except per share amounts) Gilead Stockholders' Equity

Noncontrolling

Interest Total

Stockholders'

Equity

Common Stock

Additional

Paid-In

Capital Accumulated Other Comprehensive Income Retained

Earnings

Shares Amount

Balance as of December 31, 2025 1,241   $ 1   $ 8,932   $ 39   $ 13,730   $ ( 84 ) $ 22,618

Net income —  —  —  —  2,021   —  2,021

Other comprehensive income, net —  —  —  39   —  —  39

Issuances under employee stock purchase plan 1   —  86   —  —  —  86

Issuances under equity incentive plans 5   —  81   —  —  —  81

Stock-based compensation —  —  218   —  —  —  218

Repurchases of common stock under repurchase programs ($ 136.54 average price per share)

( 3 ) —  ( 13 ) —  ( 406 ) —  ( 419 )

Repurchases of common stock for employee tax withholding under equity incentive plans and other ( 1 ) —  —  —  ( 179 ) —  ( 179 )

Dividends declared ($ 0.82 per share)

—  —  —  —  ( 1,035 ) —  ( 1,035 )

Balance as of March 31, 2026 1,242   $ 1   $ 9,305   $ 78   $ 14,131   $ ( 84 ) $ 23,431

Three Months Ended March 31, 2025

(in millions, except per share amounts) Gilead Stockholders' Equity

Noncontrolling

Interest Total

Stockholders'

Equity

Common Stock

Additional

Paid-In

Capital Accumulated Other Comprehensive Income Retained

Earnings

Shares Amount

Balance as of December 31, 2024 1,246   $ 1   $ 7,700   $ 132   $ 11,497   $ ( 84 ) $ 19,246

Net income —  —  —  —  1,315   —  1,315

Other comprehensive loss, net —  —  —  ( 40 ) —  —  ( 40 )

Issuances under employee stock purchase plan 1   —  82   —  —  —  82

Issuances under equity incentive plans 7   —  175   —  —  —  175

Stock-based compensation —  —  211   —  —  —  211

Repurchases of common stock under repurchase programs ($ 102.46 average price per share)

( 7 ) —  ( 29 ) —  ( 701 ) —  ( 730 )

Repurchases of common stock for employee tax withholding under equity incentive plans and other ( 2 ) —  —  —  ( 176 ) —  ( 176 )

Dividends declared ($ 0.79 per share)

—  —  —  —  ( 1,004 ) —  ( 1,004 )

Balance as of March 31, 2025 1,245   $ 1   $ 8,138   $ 92   $ 10,931   $ ( 84 ) $ 19,078

See accompanying notes.

6

GILEAD SCIENCES, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(unaudited)

Three Months Ended

March 31,

(in millions) 2026 2025

Operating Activities:

Net income $ 2,021   $ 1,315

Adjustments to reconcile Net income to Net cash provided by operating activities:

Depreciation expense 93   97

Amortization expense 596   599

Stock-based compensation expense 218   209

Deferred income taxes 179   ( 199 )

Net (gain) loss from equity securities ( 142 ) 426

Acquired in-process research and development expenses 107   253

Other, net 183   91

Changes in operating assets and liabilities:

Accounts receivable, net 134   79

Inventories ( 52 ) ( 223 )

Prepaid expenses and other 5   12

Accounts payable ( 67 ) ( 105 )

Income tax assets and liabilities, net ( 29 ) ( 552 )

Accrued and other liabilities ( 702 ) ( 244 )

Net cash provided by operating activities 2,544   1,757

Investing Activities:

Purchases of marketable debt securities ( 525 ) —

Proceeds from sales of marketable debt securities 2,520   —

Proceeds from maturities of marketable debt securities 36   —

Acquisitions, including in-process research and development, net of cash acquired ( 109 ) ( 273 )

Purchases of equity securities ( 19 ) ( 16 )

Purchases of property, plant and equipment ( 117 ) ( 104 )

Other investing activities, net ( 17 ) ( 23 )

Net cash provided by (used in) investing activities 1,770   ( 415 )

Financing Activities:

Proceeds from issuances of common stock 166   252

Repurchases of common stock under repurchase programs ( 419 ) ( 730 )

Repayments of debt and other obligations ( 2,766 ) ( 1,762 )

Payments of dividends ( 1,040 ) ( 1,010 )

Other financing activities, net ( 179 ) ( 176 )

Net cash used in financing activities ( 4,239 ) ( 3,426 )

Effect of exchange rate changes on cash and cash equivalents ( 11 ) 19

Net change in cash and cash equivalents 65   ( 2,065 )

Cash and cash equivalents at beginning of period 7,564   9,991

Cash and cash equivalents at end of period $ 7,628   $ 7,926

See accompanying notes.

7

GILEAD SCIENCES, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(unaudited)

1.     SUMMARY OF BUSINESS AND SIGNIFICANT ACCOUNTING POLICIES

The accompanying Condensed Consolidated Financial Statements and related Notes to Condensed Consolidated Financial Statements of Gilead Sciences, Inc. (“Gilead,” “we,” “our” or “us”) should be read in conjunction with the audited Consolidated Financial Statements and the related notes thereto for the year ended December 31, 2025, included in our Annual Report on Form 10-K filed with U.S. Securities and Exchange Commission. There have been no material changes to the summary of our business or significant accounting policies as disclosed in that filing.

These interim financial statements have been prepared in accordance with U.S. generally accepted accounting principles for interim financial information and include all adjustments consisting of normal recurring adjustments that the management of Gilead believes are necessary for a fair presentation of the periods presented and are not necessarily indicative of results expected for the full fiscal year or for any subsequent interim period. We have evaluated subsequent events through the report issuance date and determined that there are no further events or transactions to be disclosed other than those already disclosed elsewhere in the Notes to Condensed Consolidated Financial Statements included in this Quarterly Report on Form 10-Q.

Certain amounts and percentages in these Condensed Consolidated Financial Statements and accompanying notes may not sum or recalculate due to rounding.

8

2.     REVENUES

Disaggregation of Revenues

The following table summarizes our Total revenues:

Three Months Ended March 31, 2026 Three Months Ended March 31, 2025

(in millions) U.S. Europe Rest of World Total U.S. Europe Rest of World Total

Product sales:

HIV

Biktarvy $ 2,573   $ 437   $ 352   $ 3,361   $ 2,474   $ 375   $ 301   $ 3,150

Descovy 761   23   23   807   538   21   27   586

Genvoya 215   33   16   264   305   40   19   364

Odefsey 153   59   9   221   215   57   10   281

Symtuza - Revenue share (1)

107   28   3   138   82   29   3   114

Yeztugo 158   —   7   166   —   —   —   —

Other HIV (2)

36   27   9   73   50   31   10   91

Total HIV 4,004   607   419   5,030   3,664   553   370   4,587

Liver Disease

Livdelzi 115   18   —   133   40   —   —   40

Sofosbuvir/Velpatasvir (3)

141   60   82   283   166   80   99   346

Vemlidy 91   13   132   237   100   12   140   252

Other Liver Disease (4)

15   78   21   114   28   76   17   121

Total Liver Disease 362   170   235   767   335   168   256   758

Veklury 112   14   18   144   199   22   82   302

Oncology

Cell Therapy

Tecartus 30   37   8   75   40   31   8   78

Yescarta 120   146   67   332   160   149   77   386

Total Cell Therapy 150   183   74   407   200   180   84   464

Trodelvy 253   95   54   402   181   75   37   293

Total Oncology 403   278   129   810   381   255   121   757

Other

AmBisome 7   59   72   138   5   67   66   139

Other (5)

39   8   11   58   47   9   14   70

Total Other 46   67   83   196   52   76   81   209

Total product sales 4,926   1,137   883   6,946   4,631   1,073   909   6,613

Royalty, contract and other revenues —   8   6   14   37   11   6   54

Total revenues $ 4,926   $ 1,144   $ 889   $ 6,960   $ 4,668   $ 1,084   $ 915   $ 6,667

_______________________________

(1)     Represents our revenue from cobicistat (“C”), emtricitabine (“FTC”) and tenofovir alafenamide (“TAF”) in Symtuza (darunavir/C/FTC/TAF), a fixed dose combination product commercialized by Janssen Sciences Ireland Unlimited Company (“Janssen Ireland”).

(2)     Includes Atripla, Complera/Eviplera, Emtriva, Stribild, Sunlenca, Truvada and Tybost.

(3)     Includes Epclusa and the authorized generic version of Epclusa sold by Gilead’s separate subsidiary, Asegua Therapeutics LLC (“Asegua”).

(4)     Includes ledipasvir/sofosbuvir (Harvoni and the authorized generic version of Harvoni sold by Asegua), Hepcludex, Hepsera, Sovaldi, Viread and Vosevi.

(5)     Includes Cayston, Jyseleca, Letairis and Zydelig.

9

Revenues Recognized from Performance Obligations Satisfied in Prior Years

The following table summarizes revenues recognized from performance obligations satisfied in prior years:

Three Months Ended

March 31,

(in millions) 2026 2025

Revenue share with Janssen Ireland and royalties for licenses of intellectual property $ 152   $ 157

Changes in estimates $ 232   $ 214

Contract Balances

The following table summarizes our contract balances:

(in millions) March 31, 2026 December 31, 2025

Contract assets $ 589   $ 629

Contract liabilities (1)

$ 47   $ 48

_______________________________

(1)     Future revenues recognized from contract liabilities are not expected to be material in any one year.

3.     FAIR VALUE MEASUREMENTS

Recurring Fair Value Measurements

The following table summarizes the types of assets and liabilities measured at fair value on a recurring basis by level within the fair value hierarchy:

March 31, 2026 December 31, 2025

(in millions) Level 1 Level 2 Level 3 Total Level 1 Level 2 Level 3 Total

Assets:

Available-for-sale debt securities:

U.S. treasury securities $ 298   $ —   $ —   $ 298   $ 1,224   $ —   $ —   $ 1,224

U.S. government agencies securities —   —   —   —   —   15   —   15

Corporate debt securities —   555   —   555   —   1,398   —   1,398

Residential mortgage and asset-backed securities —   144   —   144   —   407   —   407

Equity securities:

Money market funds 5,966   —   —   5,966   6,150   —   —   6,150

Publicly traded equity securities 2,147   —   —   2,147   1,961   —   —   1,961

Deferred compensation plan 405   —   —   405   406   —   —   406

Foreign currency derivative contracts —   73   —   73   —   56   —   56

Total $ 8,817   $ 772   $ —   $ 9,589   $ 9,741   $ 1,875   $ —   $ 11,616

Liabilities:

Contingent consideration liability $ —   $ —   $ 275   $ 275   $ —   $ —   $ 278   $ 278

Deferred compensation plan 405   —   —   405   406   —   —   406

Foreign currency derivative contracts —   30   —   30   —   72   —   72

Total $ 405   $ 30   $ 275   $ 710   $ 406   $ 72   $ 278   $ 757

Level 2 Inputs

Available-for-Sale Debt Securities

For our available-for-sale debt securities, we estimate the fair values by reviewing trading activity and pricing as of the measurement date and by taking into consideration valuations obtained from third-party pricing services. The pricing services utilize industry standard valuation models, including both income-based and market-based approaches, for which all significant inputs are observable, either directly or indirectly, to estimate the fair value. These inputs include reported trades of and broker/dealer quotes on the same or similar securities, issuer credit spreads, benchmark securities, prepayment/default projections based on historical data and other observable inputs.

10

Foreign Currency Derivative Contracts

Our foreign currency derivative contracts have maturities of 18 months or less and all are with counterparties that have a minimum credit rating of A- or equivalent by S&P Global Ratings, Moody’s Investors Service, Inc. or Fitch Ratings, Inc. We estimate the fair values of these contracts by utilizing an income-based industry standard valuation model for which all significant inputs are observable, either directly or indirectly. These inputs include foreign currency exchange rates, Secured Overnight Financing Rate (“SOFR”) and swap rates. These inputs, where applicable, are observable at commonly quoted intervals.

Level 3 Inputs

Contingent Consideration Liability

In connection with our first quarter 2021 acquisition of MYR GmbH, we are subject to a potential contingent consideration payment of up to € 300 million, subject to customary adjustments, which is revalued each reporting period using probability-weighted scenarios for U.S. Food and Drug Administration (“FDA”) approval of bulevirtide until the related contingency is resolved.

The following table summarizes the change in fair value of our contingent consideration liability:

Three Months Ended

March 31,

(in millions) 2026 2025

Beginning balance $ 278   $ 206

Changes in valuation assumptions (1)

3   2

Effect of foreign exchange remeasurement (2)

( 6 ) 7

Ending balance (3)

$ 275   $ 216

________________________________

(1)     Included in Research and development expenses on our Condensed Consolidated Statements of Operations.

(2)     Included in Other (income) expense, net on our Condensed Consolidated Statements of Operations.

(3)     Included in Other current liabilities on our Condensed Consolidated Balance Sheets as of March 31, 2026 and December 31, 2025.

Fair Value Level Transfers

There were no transfers between Level 1, Level 2 and Level 3 in the periods presented.

Other Fair Value Disclosures

Senior Unsecured Notes

The following table summarizes the total estimated fair value and carrying value of our senior unsecured notes, determined using Level 2 inputs based on their quoted market values:

(in millions) March 31, 2026 December 31, 2025

Fair value $ 19,178   $ 22,342

Carrying value $ 21,080   $ 23,827

Liability Related to Future Royalties

We recorded a liability related to future royalties as part of our 2020 acquisition of Immunomedics, Inc., which is subsequently amortized using the effective interest method over the remaining estimated life. The fair value of the liability related to future royalties, determined using Level 3 inputs, was approximately $ 0.8 billion as of March 31, 2026 and December 31, 2025, and the carrying value was $ 1.1 billion as of March 31, 2026 and December 31, 2025.

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4.      INVESTMENTS

Available-for-Sale Debt Securities

The following table summarizes our available-for-sale debt securities:

March 31, 2026 December 31, 2025

(in millions) Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Estimated Fair Value Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Estimated Fair Value

U.S. treasury securities $ 300   $ —   $ ( 1 ) $ 298   $ 1,222   $ 3   $ —   $ 1,224

U.S. government agencies securities —   —   —   —   15   —   —   15

Corporate debt securities 557   —   ( 2 ) 555   1,392   7   —   1,398

Residential mortgage and asset-backed securities 144   —   —   144   405   2   —   407

Total $ 1,000   $ 1   $ ( 4 ) $ 997   $ 3,033   $ 11   $ ( 1 ) $ 3,044

The total gross unrealized losses in the table above relate to available-for-sale debt securities, primarily corporate debt securities and U.S. treasury securities, with an estimated fair value of approximately $ 669 million and $ 724 million that have been in a continuous unrealized loss position for less than 12 months as of March 31, 2026 and December 31, 2025, respectively. No allowance for credit losses was recognized for investments with unrealized losses as of March 31, 2026 as the unrealized losses were primarily driven by broader change in interest rates with no adverse conditions identified that would prevent the issuer from making scheduled principal and interest payments. In April 2026, we sold all remaining securities.

The following table summarizes the classification of our available-for-sale debt securities on our Condensed Consolidated Balance Sheets:

(in millions) March 31, 2026

Short-term marketable debt securities $ 15

Long-term marketable debt securities 983

Total $ 997

The following table summarizes our available-for-sale debt securities by contractual maturity:

March 31, 2026

(in millions) Amortized Cost Fair Value

Within one year $ 15   $ 15

After one year through five years 982   979

After five years through ten years 4   4

Total $ 1,000   $ 997

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Equity Securities

The following table summarizes the classification of our equity securities on our Condensed Consolidated Balance Sheets, including certain equity method investments for which we elected and applied the fair value option as we believe it best reflects the underlying economics of these investments:

(in millions) March 31, 2026 December 31, 2025

Equity securities measured at fair value:

Cash and cash equivalents:

Money market funds $ 5,966   $ 6,150

Prepaid and other current assets:

Equity method investment in Galapagos NV (“Galapagos”) – fair value option 504   551

Equity method investment in Arcus Biosciences, Inc. – fair value option 679   749

Other equity method investments – fair value option (1)

155   183

Other 836   499

Other long-term assets 379   386

Equity method investments and other equity securities without readily determinable fair values:

Other long-term assets (2)

308   393

Total $ 8,827   $ 8,909

________________________________

(1)     Mostly comprised of our equity interest in Assembly Biosciences, Inc. (“Assembly”), which was approximately 29 % of outstanding Assembly stock at the time of our latest purchase of shares.

(2)     Mostly comprised of equity interests in certain collaboration partners and investment funds that are considered to be variable interest entities (“VIEs”) for which we are not the primary beneficiary. Our maximum exposure to loss as a result of our involvement in these VIEs is limited to the value of our investment.

The following table summarizes net unrealized gains and losses related to equity securities still held as of the respective ending balance sheet dates for the periods below, included in Other (income) expense, net on our Condensed Consolidated Statements of Operations:

Three Months Ended

March 31,

(in millions) 2026 2025

Unrealized loss, net, related to fair value option investments $ 146   $ 276

Unrealized (gain) loss, net, related to all other equity investments ( 277 ) 160

Total unrealized (gain) loss, net $ ( 131 ) $ 436

Related Party Transaction

During the three months ended March 31, 2026, we donated certain equity securities to the Gilead Foundation, a California nonprofit public benefit corporation for which certain of our officers serve as directors, and recorded a related expense of $ 63 million in Selling, general and administrative expenses on our Condensed Consolidated Statements of Operations.

5.      DERIVATIVES

Our operations in foreign countries expose us to risk associated with foreign currency exchange rate fluctuations between the U.S. dollar and various foreign currencies, primarily the Euro. To partially mitigate the impact of changes in currency exchange rates on net cash flows from our foreign currency denominated sales as well as outstanding monetary assets and liabilities, we enter into foreign currency exchange forward contracts. In general, the risk of foreign currency fluctuations related to our operations is offset by corresponding gains and losses from our derivative instruments. By working only with major banks and closely monitoring current market conditions, we seek to limit the credit risk that counterparties to these contracts may be unable to perform. We enter into contracts that permit net settlement at maturity. In addition, our overall risk of loss in the event of counterparty default is limited to the amount of any net unrealized gains on outstanding contracts (i.e., including the impact of offsetting unrealized losses). We do not enter into derivative contracts for trading purposes.

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The derivative instruments we use to mitigate our exposures for certain monetary assets and liabilities that are denominated in a non-functional currency are not designated as hedges. The derivative instruments we use to mitigate our exposures for forecasted product sales are designated as cash flow hedges and have maturities of 18 months or less.

We held foreign currency exchange contracts with outstanding notional amounts of $ 3.6 billion and $ 3.9 billion as of March 31, 2026 and December 31, 2025, respectively.

While all our derivative contracts allow us the right to offset assets and liabilities, we have presented amounts on our Condensed Consolidated Balance Sheets on a gross basis. Further, our contracts generally do not require financial collateral. The following table summarizes the classification and fair values of derivative instruments, including the potential effect of offsetting:

March 31, 2026

(in millions) Prepaid and other current assets Other long-term assets Total Derivative Assets Other current liabilities Other long-term liabilities Total Derivative Liabilities

Foreign currency exchange contracts designated as hedges $ 45   $ 7   $ 52   $ 28   $ 1   $ 29

Foreign currency exchange contracts not designated as hedges 21   —   21   1   —   1

Total derivatives presented gross on the Condensed Consolidated Balance Sheets $ 73   $ 30

Total derivatives not offset on the Condensed Consolidated Balance Sheets ( 24 ) ( 24 )

Net amount (legal offset) $ 49   $ 6

December 31, 2025

(in millions) Prepaid and other current assets Other long-term assets Total Derivative Assets Other current liabilities Other long-term liabilities Total Derivative Liabilities

Foreign currency exchange contracts designated as hedges $ 18   $ 2   $ 20   $ 62   $ 3   $ 65

Foreign currency exchange contracts not designated as hedges 36   —   36   7   —   7

Total derivatives presented gross on the Condensed Consolidated Balance Sheets $ 56   $ 72

Total derivatives not offset on the Condensed Consolidated Balance Sheets ( 40 ) ( 40 )

Net amount (legal offset) $ 16   $ 32

The following table summarizes the effect of our derivative contracts on our Condensed Consolidated Financial Statements:

Three Months Ended

March 31,

(in millions) 2026 2025

Derivatives designated as hedges:

Net gain (loss) recognized in Accumulated other comprehensive income $ 45   $ ( 45 )

Net (loss) gain reclassified from Accumulated other comprehensive income into Product sales $ ( 24 ) $ 21

Derivatives not designated as hedges:

Net gain (loss) recognized in Other (income) expense, net $ 3   $ ( 5 )

Approximately $ 2 million of pre-tax net losses related to the hedged forecasted transactions reported in Accumulated other comprehensive income as of March 31, 2026 are expected to be reclassified to Product sales within 12 months. There were no discontinuances of cash flow hedges for the three months ended March 31, 2026 and 2025.

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The cash flow effects of our derivative contracts for the three months ended March 31, 2026 and 2025 were included within Net cash provided by operating activities on our Condensed Consolidated Statements of Cash Flows.

6.     ACQUISITIONS, COLLABORATIONS AND OTHER ARRANGEMENTS

We enter into acquisitions, licensing and strategic collaborations and other similar arrangements with third parties for the research, development and commercialization of certain products and product candidates. The collaborations involve two or more parties who are active participants in the operating activities of the collaboration and are exposed to significant risks and rewards depending on the commercial success of the activities. The financial terms of these arrangements may include non-refundable upfront payments, expense reimbursements, payments by us for options to acquire certain rights, contingent obligations by us for potential development and regulatory milestone payments and/or sales-based milestone payments, royalty payments, revenue or profit-sharing arrangements, cost-sharing arrangements and equity investments.

Acquisitions

Arcellx

In April 2026, we closed an agreement to acquire Arcellx, Inc. (“Arcellx”), a public biotechnology company focused on delivering a new class of innovative immunotherapies for patients with cancer and other incurable diseases. Under the terms of the agreement, we successfully completed our tender offer for all outstanding shares of Arcellx other than those already owned by Gilead for approximately $ 7.1 billion in cash consideration. As a result, Arcellx became our wholly-owned subsidiary. We will also pay one non-transferable contingent value right of $ 5 per share upon the achievement of at least $ 6.0 billion in cumulative global net sales of anitocabtagene autoleucel (“anito-cel”) from launch through year-end 2029.

Prior to the acquisition, we had been engaged in a global strategic collaboration with Arcellx to co-develop and co-commercialize Arcellx’s lead late-stage product candidate, anito-cel, an investigational BCMA-directed chimeric antigen receptor T-cell therapy for patients with relapsed and/or refractory multiple myeloma. In conjunction with the collaboration, we obtained licenses to develop and manufacture certain products, including anito-cel, and to commercialize those products outside the U.S. and to co-commercialize those products in the U.S. with Arcellx. We also made various purchases of Arcellx shares. Under the agreement, Arcellx was eligible to receive performance-based development and regulatory milestone payments, with further commercial milestone payments, profit split payments on co-promoted products and royalties on at least a portion of worldwide net sales, depending on whether Arcellx opted in to co-promote the future products.

We expect to account for this transaction as an asset acquisition in the second quarter of 2026 since the acquired intellectual property rights related to anito-cel represent substantially all of the fair value of the gross assets acquired.

Tubulis

In April 2026, we entered into a definitive agreement to acquire Tubulis GmbH (“Tubulis”), a private Germany-based, clinical-stage biotechnology company developing next-generation antibody-drug conjugates (“ADC”), for approximately $ 3.2 billion in upfront cash consideration, subject to customary adjustments, payable at closing, and up to $ 1.9 billion in contingent milestone payments. The closing of the transaction is subject to the expiration or termination of certain regulatory filings and other customary conditions. Upon closing, Tubulis will become our wholly-owned subsidiary.

We expect to account for this transaction as an asset acquisition in the second quarter of 2026 since the lead asset, TUB-040, a NaPi2b-directed topoisomerase-I inhibitor ADC currently in Phase 1b/2 development for platinum-resistant ovarian cancer and non-small cell lung cancer (“NSCLC”), represents substantially all of the fair value of the gross assets acquired.

Ouro Medicines

In March 2026, we entered into a definitive agreement to acquire Ouro Medicines, LLC (“Ouro”), a privately held biotechnology company focused on developing T cell engager (“TCE”) therapies for autoimmune diseases, for approximately $ 1.7 billion in upfront cash consideration, subject to customary adjustments, payable at closing, and up to $ 500 million in contingent milestone payments. The closing of the transaction is subject to the expiration or termination of certain regulatory filings and other customary conditions. Upon closing, which is anticipated in the second quarter of 2026, Ouro will become our wholly-owned subsidiary.

We expect to account for this transaction as an asset acquisition in the second quarter of 2026 since the lead asset, OM336 (gamgertamig), a clinical-stage BCMAxCD3 TCE, represents substantially all of the fair value of the gross assets acquired.

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Collaborations and Other Arrangements

Galapagos

In March 2026, we entered into an agreement (the “Framework Agreement”) with Galapagos, effective upon the closing of our definitive agreement to acquire Ouro, for a research and development collaboration on the acquired Ouro assets. Under the Framework Agreement, Galapagos will pay 50 % of the upfront cash consideration and 50 % of any contingent milestone payments payable to Ouro’s shareholders. Additionally, Galapagos will absorb substantially all of Ouro’s operating assets, retain its employees and be responsible for all development costs prior to registrational studies for gamgertamig, with later clinical development costs being shared equally between Gilead and Galapagos. Gilead will retain commercialization rights and pay Galapagos royalties of 20 % to 23 % of net sales of gamgertamig products.

LEO Pharma

In January 2025, we entered into a strategic partnership with LEO Pharma A/S (“LEO Pharma”) to accelerate the development and commercialization of LEO Pharma’s small molecule oral signal transducer and activator of transcription 6 (“STAT6”) programs for the potential treatment of patients with inflammatory diseases. Gilead acquired global rights to develop, manufacture, and commercialize the small molecule oral STAT6 program. LEO Pharma will have the option to potentially co-commercialize oral programs for dermatology outside the U.S. LEO Pharma will hold exclusive global rights to STAT6 topical formulations in dermatology. We made a $ 250 million upfront payment to LEO Pharma, which was charged to Acquired in-process research and development expenses on our Condensed Consolidated Statements of Operations in 2025. In addition, LEO Pharma is eligible to receive up to approximately $ 1.5 billion in additional milestone payments and may also receive tiered royalties on sales of oral STAT6 products.

7.      INTANGIBLE ASSETS

The following table summarizes our Intangible assets, net:

March 31, 2026 December 31, 2025

(in millions) Gross

Carrying

Amount Accumulated

Amortization Foreign Currency Translation Adjustment Net

Carrying Amount Gross

Carrying

Amount Accumulated

Amortization Foreign Currency Translation Adjustment Net

Carrying Amount

Finite-lived assets:

Intangible asset – sofosbuvir $ 10,720   $ ( 8,623 ) $ —   $ 2,097   $ 10,720   $ ( 8,448 ) $ —   $ 2,272

Intangible asset – axicabtagene ciloleucel

7,110   ( 3,229 ) —   3,881   7,110   ( 3,127 ) —   3,983

Intangible asset – Trodelvy

11,730   ( 4,434 ) —   7,296   11,730   ( 4,164 ) —   7,566

Intangible asset – Hepcludex

845   ( 437 ) —   408   845   ( 415 ) —   430

Other 1,458   ( 1,059 ) —   400   1,483   ( 1,056 ) —   428

Total finite-lived assets 31,863   ( 17,782 ) —   14,082   31,888   ( 17,211 ) —   14,678

Indefinite-lived assets – IPR&D (1)

2,300   —  —   2,300   2,300   —  —   2,300

Total intangible assets $ 34,163   $ ( 17,782 ) $ —   $ 16,382   $ 34,188   $ ( 17,211 ) $ —   $ 16,978

_______________________________

(1)     The Indefinite-lived assets – IPR&D balance as of March 31, 2026 was comprised of $ 1.75 billion related to sacituzumab govitecan-hziy for NSCLC and $ 550 million related to bulevirtide.

Impairment Assessments

No indicators of impairment resulting in an adjustment to the carrying value of intangible assets were identified for the three months ended March 31, 2026 and 2025.

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8.      OTHER FINANCIAL INFORMATION

Accounts Receivable, Net

The following table summarizes our Accounts receivable, net:

(in millions) March 31, 2026 December 31, 2025

Accounts receivable (1)

$ 5,544   $ 5,895

Less: allowances for chargebacks 661   843

Less: allowances for cash discounts and other 98   97

Less: allowances for credit losses 44   41

Accounts receivable, net $ 4,741   $ 4,913

_______________________________

(1)     As of March 31, 2026, the majority of our Accounts receivable balance arises from product sales in the U.S. and Europe and approximately 60 % relates to three wholesalers—Cardinal Health, Inc., Cencora, Inc. and McKesson Corporation—and their specialty distributor affiliates.

Inventories

The following table summarizes our Inventories:

(in millions) March 31, 2026 December 31, 2025

Raw materials $ 1,357   $ 1,414

Work in process 1,276   1,306

Finished goods 1,706   1,647

Total $ 4,339   $ 4,368

Reported as:

Inventories $ 1,914   $ 1,774

Other long-term assets (1)

2,424   2,594

Total $ 4,339   $ 4,368

_______________________________

(1)     As of March 31, 2026, this amount primarily consists of raw materials and work in process.

As of March 31, 2026, we held approximately $ 638  million of pre-commercial Trodelvy inventory for which the manufacturing process has not yet been approved by FDA.

Property, Plant and Equipment, Net

The following table summarizes our Property, plant and equipment, net:

(in millions) March 31, 2026 December 31, 2025

Property, plant and equipment $ 8,422   $ 8,302

Less: accumulated depreciation 2,784   2,696

Property, plant and equipment, net $ 5,638   $ 5,606

The following table summarizes Depreciation expense:

Three Months Ended

March 31,

(in millions) 2026 2025

Depreciation expense $ 93   $ 97

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Accumulated Other Comprehensive Income

The following tables summarize the changes in Accumulated other comprehensive income by component, net of tax:

(in millions) Foreign Currency Translation Available-for-Sale Debt Securities Cash Flow Hedges Total

Balance as of December 31, 2025 $ 74   $ 8   $ ( 43 ) $ 39

Net unrealized (loss) gain, net of income tax expense (benefit) of $ 0 , $( 3 ), and $ 6 , respectively

( 10 ) ( 10 ) 40   20

(Gain) loss reclassified to net income, net of income tax benefit of $ 0 , $ 0 , and $( 3 ), respectively

—   ( 2 ) 21   19

Other comprehensive (loss) income, net ( 10 ) ( 12 ) 61   39

Balance as of March 31, 2026 $ 64   $ ( 3 ) $ 18   $ 78

(in millions) Foreign Currency Translation Available-for-Sale Debt Securities Cash Flow Hedges Total

Balance as of December 31, 2024 $ 36   $ —   $ 96   $ 132

Net unrealized gain (loss), net of income tax benefit of $ 0 , $ 0 , and $( 6 ), respectively

18   —   ( 40 ) ( 22 )

Gain reclassified to net income, net of income tax expense of $ 0 , $ 0 , and $ 3 , respectively

—   —   ( 18 ) ( 18 )

Other comprehensive income (loss), net 18   —   ( 58 ) ( 40 )

Balance as of March 31, 2025 $ 54   $ —   $ 38   $ 92

The following table summarizes the reclassifications out of Accumulated other comprehensive income and into Net income, including the affected line items from our Condensed Consolidated Statements of Operations:

Three Months Ended

March 31,

(in millions) 2026 2025 Line Item Affected

Net (loss) gain related to cash flow hedges $ ( 24 ) $ 21   Product sales

Net gain related to available-for-sale debt securities $ ( 2 ) $ —   Other (income) expense, net

Income tax (benefit) expense $ ( 3 ) $ 3   Income tax expense

Restructuring

During the three months ended March 31, 2026 and 2025, we incurred restructuring charges primarily related to severance costs resulting from reductions in our workforce.

The following table summarizes the affected line items from our Condensed Consolidated Statements of Operations:

Three Months Ended

March 31,

(in millions) 2026 2025

Research and development expenses $ 14   $ 38

Selling, general and administrative expenses 25   36

Restructuring charges $ 40   $ 74

As of March 31, 2026, we had a remaining liability of $ 73 million on our Condensed Consolidated Balance Sheets associated with restructuring charges, a majority of which we anticipate will be paid in the next 12 months.

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Other (Income) Expense, Net

The following table summarizes the components of Other (income) expense, net:

Three Months Ended

March 31,

(in millions) 2026 2025

(Gain) loss from equity securities, net $ ( 142 ) $ 426

Interest income ( 95 ) ( 94 )

Other, net 2   ( 4 )

Other (income) expense, net $ ( 235 ) $ 328

9 .     DEBT AND CREDIT FACILITIES

The following table summarizes the carrying amount of our borrowings under various financing arrangements:

(in millions) Carrying Amount

Type of Borrowing Issue Date Maturity Date Interest Rate March 31, 2026 December 31, 2025

Senior Unsecured September 2015 March 2026 3.65 % —   2,750

Senior Unsecured September 2016 March 2027 2.95 % 1,249   1,249

Senior Unsecured September 2020 October 2027 1.20 % 749   749

Senior Unsecured November 2024 November 2029 4.80 % 747   747

Senior Unsecured September 2020 October 2030 1.65 % 996   996

Senior Unsecured September 2023 October 2033 5.25 % 994   994

Senior Unsecured November 2024 June 2035 5.10 % 992   992

Senior Unsecured September 2015 September 2035 4.60 % 994   994

Senior Unsecured September 2016 September 2036 4.00 % 744   744

Senior Unsecured September 2020 October 2040 2.60 % 990   990

Senior Unsecured December 2011 December 2041 5.65 % 997   997

Senior Unsecured March 2014 April 2044 4.80 % 1,738   1,738

Senior Unsecured November 2014 February 2045 4.50 % 1,736   1,736

Senior Unsecured September 2015 March 2046 4.75 % 2,225   2,225

Senior Unsecured September 2016 March 2047 4.15 % 1,731   1,731

Senior Unsecured September 2020 October 2050 2.80 % 1,480   1,480

Senior Unsecured September 2023 October 2053 5.55 % 989   989

Senior Unsecured November 2024 November 2054 5.50 % 989   989

Senior Unsecured November 2024 November 2064 5.60 % 739   739

Total senior unsecured notes 21,080   23,827

Liability related to future royalties 1,094   1,110

Total debt, net 22,174   24,937

Less: Current portion of long-term debt, net 1,313   2,807

Total Long-term debt, net $ 20,861   $ 22,129

Senior Unsecured Notes

We are required to comply with certain covenants under our note indentures governing our senior unsecured notes. As of March 31, 2026, we were not in violation of any covenants. In March 2026, we repaid $ 2.75 billion of principal balance related to our senior unsecured notes due March 2026.

Term Loan Facility

In April 2026, we entered into a term loan facility credit agreement (the “Term Loan Facility”) with a group of institutional lenders to provide for a one-year senior unsecured term loan facility in an aggregate principal amount of $ 4.7 billion. Pursuant to the Term Loan Facility, we borrowed an aggregate principal amount of $ 1.1 billion.

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The Term Loan Facility contains customary representations, warranties, affirmative and negative covenants and events of default. The Term Loan Facility bears interest at either (i) Term SOFR plus the Applicable Margin or (ii) Base Rate plus the Applicable Margin, each as defined in the Term Loan Facility. We may prepay or reduce the amount borrowed under the Term Loan Facility in whole or in part at any time without premium or penalty.

Revolving Credit Facility

As of March 31, 2026 and December 31, 2025, there were no amounts outstanding under our $ 2.5 billion revolving credit facility maturing in June 2029, and we were in compliance with all covenants.

10 .     COMMITMENTS AND CONTINGENCIES

Legal Proceedings

We are a party to various legal actions. Certain significant matters are described below. We recognize accruals for such actions to the extent that we conclude that a loss is both probable and reasonably estimable. We accrue for the best estimate of a loss within a range; however, if no estimate in the range is better than any other, then we accrue the minimum amount in the range. If we determine that a material loss is reasonably possible and the loss or range of loss can be estimated, we disclose the possible loss. Unless otherwise noted, the outcome of these matters either is not expected to be material or is not possible to determine such that we cannot reasonably estimate the maximum potential exposure or the range of possible loss. As of March 31, 2026 and December 31, 2025, we did not have any material accruals for the matters described herein.

Litigation with Generic Manufacturers

As part of the approval process for some of our products, FDA granted us a New Chemical Entity (“NCE”) exclusivity period during which other manufacturers’ applications for approval of generic versions of our products will not be approved. Generic manufacturers may challenge the patents protecting products that have been granted NCE exclusivity one year prior to the end of the NCE exclusivity period. Generic manufacturers have sought and may continue to seek FDA approval for a similar or identical drug through an abbreviated new drug application (“ANDA”), the application form typically used by manufacturers seeking approval of a generic drug. The sale of generic versions of our products prior to their patent expiration would have a significant negative effect on our revenues and results of operations. To seek approval for a generic version of a product having NCE status, a generic company may submit its ANDA to FDA four years after the branded product’s approval.

In June 2025, we received a letter from Aspiro Pharma Ltd. (“Aspiro”), indicating that it had submitted an ANDA to FDA to request permission to market and manufacture a generic version of Veklury. Aspiro challenges six of the sixteen patents listed in the Orange Book for Veklury as not valid or not infringed by Aspiro’s proposed ANDA product. In July 2025, we filed a lawsuit against Aspiro in the U.S. District Court of New Jersey. In March 2026, this lawsuit was dismissed after Gilead and Aspiro entered into a settlement agreement, which grants a license to Aspiro to sell a generic version of Veklury starting in May 2041.

In January 2026, we received a letter from Cipla Ltd. (“Cipla”) indicating that it has submitted a new drug application under §505(b)(2) of the Federal Food, Drug, and Cosmetic Act (“505(b)(2) application”) for emtricitabine/tenofovir alafenamide tablets. The 505(b)(2) application references Descovy as the listed drug product. The 505(b)(2) application also includes a paragraph IV certification challenging two Orange Book patents for Descovy. In February 2026, we filed a lawsuit against Cipla in the U.S. District of Court of Delaware. We intend to enforce and defend our intellectual property.

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Antitrust and Consumer Protection

We, along with Bristol-Myers Squibb Company (“BMS”), Johnson & Johnson, Inc. (“Johnson & Johnson”) and Teva Pharmaceutical Industries Ltd. (“Teva”) have been named as defendants in class action lawsuits filed in 2019 and 2020 related to various drugs used to treat HIV, including drugs used in combination antiretroviral therapy. Plaintiffs allege that we (and the other defendants) engaged in various conduct to restrain competition in violation of federal and state antitrust laws and state consumer protection laws. The lawsuits, which have been consolidated, are pending in the U.S. District Court for the Northern District of California. The lawsuits seek to bring claims on behalf of direct purchasers consisting largely of wholesalers and indirect or end-payor purchasers, including health insurers and individual patients. Plaintiffs seek damages, permanent injunctive relief and other relief. In the second half of 2021 and first half of 2022, several plaintiffs consisting of retail pharmacies, individual health plans and United Healthcare, filed separate lawsuits effectively opting out of the class action cases, asserting claims that are substantively the same as the classes. These cases have been coordinated with the class actions. In March 2023, the District Court granted our motion to hold separate trials as to (i) the allegations against us and Teva seeking monetary damages relating to Truvada and Atripla (“Phase I”) and (ii) the allegations against us and, in part, Johnson & Johnson, seeking monetary damages and injunctive relief relating to Complera (“Phase II”). In May 2023, we settled claims with the direct purchaser class and the retailer opt-out plaintiffs for $ 525 million, which we paid in the second half of 2023. The settlement agreements are not an admission of liability or fault by us. In June 2023, the jury returned a complete verdict in Gilead’s favor on the remaining plaintiffs’ Phase I allegations. In November 2023, the court denied plaintiffs’ motion to set aside the verdict, and in February 2024, the court entered final judgment on the Phase I verdict and certain summary judgment rulings. In September 2024, plaintiffs filed their opening appellate briefs challenging the Phase I verdict and those summary judgment rulings. We filed our responsive briefs in January 2025. Plaintiffs filed their reply briefs in March 2025. Oral argument took place in October 2025. The court has stayed Phase II pending the appeal of Phase I. While we intend to vigorously oppose the appeal and defend against the Phase II claims, we cannot predict the ultimate outcome. If plaintiffs are successful in their appeal or Phase II claims, we could be required to pay monetary damages or could be subject to permanent injunctive relief in favor of plaintiffs.

In January 2022, we, along with BMS and Janssen Products, L.P., were named as defendants in a lawsuit filed in the Superior Court of the State of California, County of San Mateo, by Aetna, Inc. on behalf of itself and its affiliates and subsidiaries that effectively opts the Aetna plaintiffs out of the above class actions. The allegations are substantively the same as those in the class actions. The Aetna plaintiffs seek damages, permanent injunctive relief and other relief. In March 2024, the court denied our motion for judgment on the pleadings to preclude Aetna from re-litigating claims that were dismissed at summary judgment in the above class action cases. We filed a writ petition appealing the denial of our motion for judgment on the pleadings, which the appellate court denied in May 2024. In April 2024, the court granted our motion to bifurcate the case to adjudicate the issue of preclusion before litigating the merits of the case. In July 2024, Aetna filed a request to voluntarily dismiss two of its claims with prejudice, which the court subsequently granted, leaving only the claims related to Truvada and Atripla. In September 2024, Aetna filed an amended complaint with respect to these claims. In October 2024, we filed a demurrer and motion to strike plaintiff’s claims. In April 2025, the court overruled the demurrer and stated in its order that an immediate appeal is warranted. In June 2025, we filed a writ petition to the Court of Appeal, which was denied in August 2025. Trial has been scheduled for January 2027.

We intend to vigorously defend ourselves in these actions, however, we cannot predict the ultimate outcome. If plaintiffs are successful in their claims, we could be required to pay significant monetary damages or could be subject to permanent injunctive relief awarded in favor of plaintiffs, which may result in a material, adverse effect on our results of operations and financial condition, including in a particular reporting period in which any such outcome becomes probable and estimable.

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Product Liability

We have been named as a defendant in one putative class action lawsuit and various product liability lawsuits related to Viread, Truvada, Atripla, Complera and Stribild. Plaintiffs allege that Viread, Truvada, Atripla, Complera and/or Stribild caused them to experience kidney, bone and/or tooth injuries. The lawsuits, which are pending in state or federal court in California and Missouri, involve approximately 23,000 active plaintiffs. Plaintiffs in these cases seek damages and other relief on various grounds for alleged personal injury and economic loss. The first bellwether trial in California state court was scheduled to begin in October 2022 but is currently stayed pending the conclusion of appellate proceedings in the California Supreme Court. In the California federal case, Gilead agreed to make a one-time payment of approximately $ 39 million to a group of plaintiffs (approximately 2,470 plaintiffs). The federal court set a trial date of March 2027 for the first bellwether trial of the remaining cases. In the putative class action pending in Missouri, the district court issued an order in January 2026 denying, among other things, plaintiffs’ motion for class certification. The U.S. Court of Appeals for the Eighth Circuit then denied Plaintiff’s request for interlocutory appellate review of the district court’s decision to deny class certification. We intend to vigorously defend ourselves in these actions, however, we cannot predict the ultimate outcome. If plaintiffs are successful in their claims, we could be required to pay significant monetary damages, which may result in a material, adverse effect on our results of operations and financial condition, including in a particular reporting period in which any such outcome becomes probable and estimable.

Qui Tam Litigation

A former sales employee filed a qui tam lawsuit against Gilead in March 2017 in U.S. District Court for the Eastern District of Pennsylvania. Following the government’s decision not to intervene in the suit, the case was unsealed in December 2020. The lawsuit alleges that certain of Gilead’s hepatitis C virus (“HCV”) sales and marketing activities and donations to an independent charitable foundation violated the federal False Claims Act and various state false claims acts. The lawsuit seeks all available relief under these statutes. In September 2025, the court granted Gilead’s motion for summary judgment and dismissed the case. Relator has appealed the court’s ruling.

Health Choice Advocates, LLC (“Health Choice”) filed a qui tam lawsuit against Gilead in May 2020 in Texas state court. The lawsuit alleged that Gilead violated the Texas Medicare Fraud Prevention Act (“TMFPA”) through our clinical educator programs for Sovaldi and Harvoni and our HCV and HIV patient support programs. The lawsuit sought all available relief under the TMFPA. Health Choice voluntarily dismissed the case without prejudice in August 2023, and commenced a new action in October 2023, asserting largely identical allegations and claims. In the newly filed action, the Texas Attorney General has intervened as a plaintiff. Trial has been scheduled for December 2026.

We intend to vigorously defend ourselves in these actions, however, we cannot predict the ultimate outcomes. If any of these plaintiffs are successful in their claims, we could be required to pay significant monetary damages, which may result in a material, adverse effect on our results of operations and financial condition, including in a particular reporting period in which any such outcome becomes probable and estimable.

Other Matters

We are a party to various legal actions that arose in the ordinary course of our business. We do not believe that it is probable or reasonably possible that these other legal actions will have a material adverse impact on our consolidated financial position, results of operations or cash flows.

11.      EARNINGS PER SHARE

The following table shows the calculation of Basic and Diluted earnings per share:

Three Months Ended

March 31,

(in millions, except per share amounts) 2026 2025

Net income $ 2,021   $ 1,315

Shares used in basic earnings per share calculation 1,242   1,246

Dilutive effect of equity-based awards 12   13

Shares used in diluted earnings per share calculation 1,254   1,259

Basic earnings per share $ 1.63   $ 1.06

Diluted earnings per share $ 1.61   $ 1.04

Potential shares of common stock excluded from the computation of Diluted earnings per share because their effect would have been antidilutive were 2  million for the three months ended March 31, 2026 and 2025.

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12.      INCOME TAXES

The following table summarizes our Income tax expense:

Three Months Ended

March 31,

(in millions, except percentages) 2026 2025

Income before income taxes $ 2,580   $ 1,649

Income tax expense $ 559   $ 334

Effective tax rate 21.7   % 20.2   %

Our effective income tax rate of 21.7 % for the three months ended March 31, 2026 was generally consistent with the U.S. federal statutory rate of 21%.

Our effective income tax rate of 20.2 % for the three months ended March 31, 2025 differed from the U.S. federal statutory rate of 21% primarily due to tax benefits from stock-based compensation and provision to return adjustments, partially offset by fair value losses on our equity investments that are non-deductible for income tax purposes.

13.     SEGMENT INFORMATION

We have one operating segment which primarily focuses on the discovery, development and commercialization of innovative medicines in areas of unmet medical need. See Note 2. Revenues for disaggregation of our revenues by major products and by geography. Our Chief Executive Officer, as the chief operating decision-maker (“CODM”), uses Net income as the primary measure to evaluate performance, allocate resources to the operations of our company on an entity-wide basis and forecast future financial results. Managing and allocating resources on an entity-wide basis enables our CODM to assess the overall level of resources available and how to best deploy these resources across functions and research and development (“R&D”) projects based on unmet medical need, scientific data, probability of technical and regulatory successful development, market potential and other considerations, and, as necessary, reallocate resources among our internal R&D portfolio and external opportunities to best support the long-term growth of our business. Our CODM is regularly provided with entity-wide expense categories similar to those found on our Condensed Consolidated Statements of Operations, as well as the following:

Three Months Ended

March 31,

(in millions) 2026 2025

Selling and marketing expenses $ 898   $ 753

General and administrative expenses 553   505

Selling, general and administrative expenses $ 1,451   $ 1,258

Asset information is not regularly provided to the CODM for assessing performance and allocating resources other than consolidated cash, cash equivalents and marketable debt securities, which can be found on our Condensed Consolidated Balance Sheets.

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Item 2.    MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

The following discussion and analysis is intended to provide material information around events and uncertainties known to management that are relevant to an assessment of the financial condition and results of operations of Gilead and should therefore be read in conjunction with our audited Consolidated Financial Statements and the related notes thereto and other disclosures included as part of our Annual Report on Form 10-K for the year ended December 31, 2025 and our unaudited Condensed Consolidated Financial Statements for the three months ended March 31, 2026 and the related notes thereto and other disclosures (including the disclosures under Part II, Item 1A. Risk Factors) included in this Quarterly Report on Form 10-Q.

Management Overview

Gilead Sciences, Inc. (including its consolidated subsidiaries, referred to as “Gilead,” the “company,” “we,” “our” or “us”) is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. We are committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19 and cancer. We operate in more than 35 countries worldwide, with headquarters in Foster City, California.

Key Business Updates

The following represents a summary of notable business updates and events since the filing of our Annual Report on Form 10-K for the year ended December 31, 2025, including certain items from our press releases, which readers are encouraged to review in full as available on our website at www.gilead.com. The content on the referenced website does not constitute a part of and is not incorporated by reference into this Quarterly Report on Form 10-Q.

Virology

• Announced U.S. Food and Drug Administration (“FDA”) accepted New Drug Application for bictegravir and lenacapavir (“BIC/LEN”) for virologically suppressed people with HIV under priority review, with a Prescription Drug User Fee Act (“PDUFA”) date of August 27, 2026.

• Presented late-breaking Phase 3 results from the ARTISTRY-1 and ARTISTRY-2 trials at the 2026 Conference on Retroviruses and Opportunistic Infections (CROI), evaluating the investigational daily oral single-tablet regimen of BIC/LEN for virologically suppressed people with HIV. BIC/LEN maintained high levels of virologic suppression, demonstrating comparable efficacy to complex regimens and to Biktarvy at Week 48 in people with HIV who switched antiretroviral therapy. These data support global regulatory filings.

Oncology

• Completed the acquisition of Arcellx, Inc. (“Arcellx”) for $115 per share, or an implied equity value of $7.8 billion, and one contingent value right of $5 per share. This acquisition builds on an existing collaboration agreement with Arcellx for the development of anitocabtagene autoleucel (“anito-cel”) in relapsed or refractory (“R/R”) multiple myeloma (“MM”), and also adds Arcellx’s D-Domain BCMA binder that has the potential to strengthen Gilead’s portfolio in oncology and inflammation.

• Announced that the Biologics License Application for anito-cel in 4L+ R/R MM has been accepted by FDA, with a PDUFA target action date of December 23, 2026.

• Announced a definitive agreement to acquire Tubulis GmbH (“Tubulis”) a private clinical-stage biotechnology company developing next-generation antibody-drug conjugates (“ADC”), including lead asset TUB-040, a NaPi2b-directed topoisomerase-I inhibitor ADC currently in Phase 1b/2 development for platinum-resistant ovarian cancer and non-small cell lung cancer. Closing of the transaction is subject to expiration or termination of certain regulatory filings and other customary conditions.

• Received FDA full approval for Tecartus in adult patients with R/R mantle cell lymphoma, following an accelerated approval in this setting in July 2020. Tecartus’ label now includes efficacy, safety and pharmacokinetic data from Cohort 3 of the ZUMA-2 study in patients who are R/R after one or more lines of therapy and who are Bruton tyrosine kinase inhibitor-naïve.

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Inflammation

• Announced a definitive agreement to acquire Ouro Medicines, LLC (“Ouro”), a private clinical-stage biotechnology company developing T cell engager (“TCE”) therapies for autoimmune diseases. This acquisition adds Ouro’s lead asset, OM336 (gamgertamig), a BCMAxCD3 TCE, to Gilead’s portfolio. Closing of the transaction is subject to expiration or termination of certain regulatory filings and other customary conditions. Gilead has entered into a framework agreement with Galapagos NV in relation to this acquisition, which includes equally splitting the $1.675 billion upfront payment and up to $500 million in milestone payments, among other terms.

Key Financial Results

The following table summarizes our key financial results for the period and period-over-period changes:

Three Months Ended

March 31,

(in millions, except percentages and per share amounts) 2026 2025 Change

Total revenues $ 6,960  $ 6,667  4  %

Net income $ 2,021  $ 1,315  54  %

Diluted earnings per share $ 1.61  $ 1.04  54  %

Total revenues increased 4% to $7.0 billion for the three months ended March 31, 2026, compared to the same period in 2025, primarily due to higher sales of HIV products, Trodelvy and Livdelzi, partially offset by lower sales of Veklury, as well as chronic hepatitis C virus (“HCV”) and Cell Therapy products.

Net income was $2.0 billion and diluted earnings per share was $1.61 for the three months ended March 31, 2026, compared to net income of $1.3 billion and diluted earnings per share of $1.04 for the same period in 2025. The increase was primarily due to:

• Net unrealized gains from equity securities compared to net unrealized losses in 2025;

• Higher product sales; and

• Lower acquired in-process research and development (“IPR&D”) expenses; partially offset by

• Higher income tax expense; and

• Higher selling, general and administrative expenses.

Please refer to “Results of Operations” below for further information on results for the three months ended March 31, 2026.

Outlook Update

As a result of the recent acquisitions completed or announced above, we expect to record related charges of approximately $11.5 billion to Acquired in-process research and development expenses in the second quarter of 2026, which we expect to result in a net loss for the second quarter and full year 2026.

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Results of Operations

Revenues

The following table summarizes our Total revenues and period-over-period changes:

Three Months Ended March 31, 2026 Three Months Ended March 31, 2025

(in millions, except percentages) U.S. Europe Rest of World Total U.S. Europe Rest of World Total Change

Product sales:

HIV

Biktarvy $ 2,573  $ 437  $ 352  $ 3,361  $ 2,474  $ 375  $ 301  $ 3,150  7  %

Descovy 761  23  23  807  538  21  27  586  38  %

Genvoya 215  33  16  264  305  40  19  364  (28) %

Odefsey 153  59  9  221  215  57  10  281  (21) %

Symtuza - Revenue share (1)

107  28  3  138  82  29  3  114  21  %

Yeztugo 158  —  7  166  —  —  —  —  NM

Other HIV (2)

36  27  9  73  50  31  10  91  (20) %

Total HIV 4,004  607  419  5,030  3,664  553  370  4,587  10  %

Liver Disease

Livdelzi 115  18  —  133  40  —  —  40  NM

Sofosbuvir/Velpatasvir (3)

141  60  82  283  166  80  99  346  (18) %

Vemlidy 91  13  132  237  100  12  140  252  (6) %

Other Liver Disease (4)

15  78  21  114  28  76  17  121  (6) %

Total Liver Disease 362  170  235  767  335  168  256  758  1  %

Veklury 112  14  18  144  199  22  82  302  (52) %

Oncology

Cell Therapy

Tecartus 30  37  8  75  40  31  8  78  (4) %

Yescarta 120  146  67  332  160  149  77  386  (14) %

Total Cell Therapy 150  183  74  407  200  180  84  464  (12) %

Trodelvy 253  95  54  402  181  75  37  293  37  %

Total Oncology 403  278  129  810  381  255  121  757  7  %

Other

AmBisome 7  59  72  138  5  67  66  139  (1) %

Other (5)

39  8  11  58  47  9  14  70  (17) %

Total Other 46  67  83  196  52  76  81  209  (6) %

Total product sales 4,926  1,137  883  6,946  4,631  1,073  909  6,613  5  %

Royalty, contract and other revenues —  8  6  14  37  11  6  54  (75) %

Total revenues $ 4,926  $ 1,144  $ 889  $ 6,960  $ 4,668  $ 1,084  $ 915  $ 6,667  4  %

_______________________________

NM - Not Meaningful

(1)     Represents our revenue from cobicistat (“C”), emtricitabine (“FTC”) and tenofovir alafenamide (“TAF”) in Symtuza (darunavir/C/FTC/TAF), a fixed dose combination product commercialized by Janssen Sciences Ireland Unlimited Company.

(2)     Includes Atripla, Complera/Eviplera, Emtriva, Stribild, Sunlenca, Truvada and Tybost.

(3)     Includes Epclusa and the authorized generic version of Epclusa sold by Gilead’s separate subsidiary, Asegua Therapeutics LLC (“Asegua”).

(4)     Includes ledipasvir/sofosbuvir (Harvoni and the authorized generic version of Harvoni sold by Asegua), Hepcludex, Hepsera, Sovaldi, Viread and Vosevi.

(5)     Includes Cayston, Jyseleca, Letairis and Zydelig.

HIV

HIV product sales increased 10% to $5.0 billion for the three months ended March 31, 2026, compared to the same period in 2025, primarily due to higher demand and average realized price, partially offset by unfavorable inventory dynamics. In particular:

• Biktarvy sales increased 7% primarily due to higher demand, including patients switching from Genvoya and other Gilead HIV products, and average realized price, partially offset by unfavorable inventory dynamics; and

• Descovy sales increased 38% primarily due to higher average realized price and demand.

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Liver Disease

Liver Disease product sales increased 1% to $767 million for the three months ended March 31, 2026, compared to the same period in 2025, primarily due to higher demand for Livdelzi, partially offset by unfavorable inventory dynamics and lower sales for HCV products.

Veklury

Veklury product sales decreased 52% to $144 million for the three months ended March 31, 2026, compared to the same period in 2025, primarily due to lower rates of COVID-19-related hospitalizations.

Oncology

Cell Therapy

Cell Therapy product sales decreased 12% to $407 million for the three months ended March 31, 2026, compared to the same period in 2025, primarily due to lower demand reflecting ongoing competitive headwinds.

Trodelvy

Trodelvy product sales increased 37% to $402 million for the three months ended March 31, 2026, compared to the same period in 2025, primarily due to higher demand, favorable inventory dynamics and higher average realized price.

Foreign Currency Exchange Impact

We generally face exposure to movements in foreign currency exchange rates, primarily in the Euro. We use foreign currency exchange contracts to hedge a portion of our foreign currency exposures.

Approximat ely 27% and 28% of our product sales were denominated in foreign currencies during the three months ended March 31, 2026 and 2025, respectively. Foreign currency exchange, net of hedges, had a favorable impact on our total product sales of $112 million for the three months ended March 31, 2026, based on a comparison using foreign currency exchange rates from the three months ended March 31, 2025.

Costs and Expenses

The following table summarizes our costs and expenses and period-over-period changes:

Three Months Ended

March 31,

(in millions, except percentages) 2026 2025 Change

Cost of goods sold $ 1,445  $ 1,540  (6) %

Product gross margin 79.2  % 76.7  % 249 bps

Research and development expenses $ 1,372  $ 1,379  (1) %

Acquired in-process research and development expenses $ 107  $ 253  (58) %

Selling, general and administrative expenses $ 1,451  $ 1,258  15  %

Product Gross Margin

Product gross margin increased to 79.2% for the three months ended March 31, 2026, compared to the same period in 2025, primarily driven by the expiration of a royalty-related obligation and product mix.

Research and Development Expenses

Research and development expenses consist primarily of personnel costs, including salaries, benefits and stock-based compensation expense, infrastructure, materials and supplies and other support costs, research and clinical studies performed by contract research organizations and our collaboration partners and other outside services.

We manage these expenses by identifying the research and development (“R&D”) activities we expect to be performed during a given period and then prioritizing efforts based on scientific data, probability of successful technical development and regulatory approval, market potential, available human and capital resources and other considerations. We regularly review our R&D activities based on unmet medical need and, as necessary, reallocate resources among our internal R&D portfolio and external opportunities that we believe will best support the long-term growth of our business. We do not track total R&D expenses by product candidate, therapeutic area or development phase.

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The following table summarizes our Research and development expenses and period-over-period changes:

Three Months Ended

March 31,

(in millions, except percentages) 2026 2025 Change

Personnel, infrastructure and other support costs $ 861  $ 854  1  %

Clinical studies and other costs 510  524  (3) %

Research and development expenses $ 1,372  $ 1,379  (1) %

Research and development expenses remained relatively flat at $1.4 billion for the three months ended March 31, 2026, compared to the same period in 2025. Personnel, infrastructure and other support costs remained relatively flat with higher compensation largely offset by lower restructuring costs. Clinical studies and other costs decreased slightly primarily due to lower oncology clinical study activity, partially offset by higher investment in virology clinical manufacturing.

Acquired In-Process Research and Development Expenses

Acquired in-process research and development expenses are recorded when incurred and reflect costs of externally-developed IPR&D projects, acquired directly in a transaction other than a business combination, that do not have an alternative future use, including upfront and pre-commercialization milestone payments related to various collaborations and the costs of rights to IPR&D projects.

Acquired in-process research and development expenses were $107 million for the three months ended March 31, 2026, primarily related to $80 million associated with the Suzhou Genhouse Bio Co., Ltd. collaboration upfront payment.

Acquired in-process research and development expenses were $253 million for the three months ended March 31, 2025, primarily related to $250 million associated with the LEO Pharma A/S collaboration upfront payment.

See Note 6. Acquisitions, Collaborations and Other Arrangements of the Notes to Condensed Consolidated Financial Statements included in Part I, Item 1 of this Quarterly Report on Form 10-Q for additional information. Also, refer to the “Outlook Update” section above regarding significant Acquired in-process research and development expenses expected for the second quarter of 2026.

Selling, General and Administrative Expenses

Selling, general and administrative expenses are recorded when incurred and consist primarily of personnel costs, facilities and overhead costs, and selling, marketing and advertising expenses, as well as other general and administrative costs related to finance, human resources, legal and other administrative activities.

The following table summarizes our Selling, general and administrative expenses and period-over-period changes:

Three Months Ended

March 31,

(in millions, except percentages) 2026 2025 Change

Selling and marketing expenses $ 898  $ 753  19  %

General and administrative expenses 553  505  9  %

Selling, general and administrative expenses $ 1,451  $ 1,258  15  %

Selling, general and administrative expenses increased 15% to $1.5 billion for the three months ended March 31, 2026, compared to the same period in 2025. Selling and marketing expenses increased primarily due to higher HIV promotional expenses. General and administrative expenses increased primarily due to donations of equity securities made to the Gilead Foundation.

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Interest Expense and Other (Income) Expense, Net

The following table summarizes our Interest expense and Other (income) expense, net and period-over-period changes:

Three Months Ended

March 31,

(in millions, except percentages) 2026 2025 Change

Interest expense $ 240  $ 260  (8) %

Other (income) expense, net $ (235) $ 328  NM

(Gain) loss from equity securities, net $ (142) $ 426  NM

Interest income $ (95) $ (94) 1  %

Other, net $ 2  $ (4) NM

_______________________________

NM - Not Meaningful

Interest expense decreased 8% to $240 million for the three months ended March 31, 2026, compared to the same period in 2025, primarily due to lower debt balances.

Favorable movements in Other (income) expense, net for the three months ended March 31, 2026, compared to the same period in 2025, primarily related to net unrealized gains from equity securities compared to net unrealized losses in 2025.

Income Taxes

The following table summarizes our Income tax expense and period-over-period changes:

Three Months Ended

March 31,

(in millions, except percentages) 2026 2025 Change

Income before income taxes $ 2,580  $ 1,649  56  %

Income tax expense $ 559  $ 334  67  %

Effective tax rate 21.7  % 20.2  % 141 bps

Our effective tax rate increased for the three months ended March 31, 2026, compared to the same period in 2025, primarily due to provision to return adjustments that occurred in the three months ended March 31, 2025.

The Organisation for Economic Co-operation and Development (“OECD”) has developed a framework to implement a global minimum corporate tax of 15% for companies with global revenues and profits above certain thresholds (referred to as “Pillar Two”), with certain aspects effective January 1, 2024 and other aspects effective January 1, 2025. Certain countries in which we operate have enacted Pillar Two legislation, and other countries are in the process of introducing legislation to implement Pillar Two. In January 2026, the OECD announced additional administrative guidance, including a “side-by-side” framework intended to coordinate the application of Pillar Two with existing minimum tax regimes in certain jurisdictions. We do not expect Pillar Two, including the side-by-side framework, to have a material impact on our results of operations, liquidity or capital resources.

Liquidity and Capital Resources

We regularly analyze our ability to generate and obtain adequate amounts of cash to meet our short-term and long-term requirements and plans. Our capital priorities include: (i) investing in our business and R&D pipeline, (ii) continuing select partnerships and business development transactions, (iii) growing our dividend over time and (iv) repurchasing shares to offset dilution and opportunistically reduce share count. Based on our evaluation of our current position of liquidity, available capital resources and our material cash requirements, we believe that we can satisfy our capital needs for the next 12 months and the foreseeable future.

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Liquidity

Cash and cash equivalents were $7.6 billion and marketable debt securities were $997 million as of March 31, 2026. The table below summarizes our cash flow activities, followed by our analysis of changes and trends:

Three Months Ended

March 31,

(in millions, except percentages) 2026 2025 Change

Net cash provided by (used in):

Operating activities $ 2,544  $ 1,757  45  %

Investing activities 1,770  (415) NM

Financing activities (4,239) (3,426) 24  %

Effect of exchange rate changes on cash and cash equivalents (11) 19  NM

Net change in cash and cash equivalents $ 65  $ (2,065) NM

_______________________________

NM - Not Meaningful

Operating Activities

Net cash provided by operating activities is our primary source of funds, driven mainly by collections on product sales, partially offset by operating spend. Changes in working capital balances, generally associated with the timing of collections and payments, as well as unanticipated payments related to litigation, taxes or other matters, may create some variation in any given year. Net cash provided by operating activities increased for the three months ended March 31, 2026, compared to the same period in 2025, primarily due to lower income tax payments and lower inventory spend.

Investing Activities

The change in Net cash provided by (used in) investing activities for the three months ended March 31, 2026, compared to the same period in 2025, was primarily due to a partial liquidation of our marketable securities portfolio in 2026. Net cash provided by (used in) investing activities may vary in any given year depending on the favorability of strategic opportunities for the business.

Financing Activities

The change in Net cash used in financing activities for the three months ended March 31, 2026, compared to the same period in 2025, was primarily due to higher debt repayments, partially offset by lower common stock repurchases. Net cash used in financing activities may vary in any given year depending primarily on the timing of debt repayments and proceeds from debt offerings and the amount of common stock repurchases.

In April 2026, we received cash of $1.1 billion related to a borrowing under a term loan facility credit agreement with a group of institutional lenders. See Note 9. Debt and Credit Facilities of the Notes to Condensed Consolidated Financial Statements included in Part I, Item 1 of this Quarterly Report on Form 10-Q for additional information.

In May 2026, we announced that our Board of Directors declared a quarterly dividend of $0.82 per share of our common stock, with a payment date of June 29, 2026 to all stockholders of record as of the close of business on June 15, 2026. Future dividends are subject to declaration by our Board of Directors.

Capital Resources

A summary of our capital resources and material cash requirements is presented in Part II, Item 7 of our Annual Report on Form 10-K for the year ended December 31, 2025. Other than as disclosed in the Liquidity section above and in Notes 4. Investments, 6. Acquisitions, Collaborations and Other Arrangements, 9. Debt and Credit Facilities, 10. Commitments and Contingencies and 12. Income Taxes of the Notes to Condensed Consolidated Financial Statements included in Part I, Item 1 of this Quarterly Report on Form 10-Q, there were no material changes to our capital resources and material cash requirements during the three months ended March 31, 2026.

Critical Accounting Estimates

A summary of our critical accounting estimates is presented in Part II, Item 7 of our Annual Report on Form 10-K for the year ended December 31, 2025. Other than as disclosed in Notes 2. Revenues, 7. Intangible Assets, 10. Commitments and Contingencies and 12. Income Taxes of the Notes to Condensed Consolidated Financial Statements included in Part I, Item 1 of this Quarterly Report on Form 10-Q, there were no material changes to our critical accounting estimates during the three months ended March 31, 2026.

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Information Available on Our Website

Our company website is www.gilead.com. We routinely post important information for investors in the “Investors” section of our website, https://investors.gilead.com. Among other things, an estimate of Acquired IPR&D expenses is expected to be made available on the Quarterly Results page within the first ten days after the end of each quarter. The content on the referenced websites does not constitute a part of and is not incorporated by reference into this Quarterly Report on Form 10-Q.

Item 3.    QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

Information about our market risk is presented in Part II, Item 7A of our Annual Report on Form 10-K for the year ended December 31, 2025. Other than as disclosed in Notes 3. Fair Value Measurements, 4. Investments, 5. Derivatives and 9. Debt and Credit Facilities of the Notes to Condensed Consolidated Financial Statements included in Part I, Item 1 of this Quarterly Report on Form 10-Q, there were no material changes to these disclosures.

Item 4.    CONTROLS AND PROCEDURES

Evaluation of Disclosure Controls and Procedures

An evaluation as of March 31, 2026 was carried out under the supervision and with the participation of our management, including our Chief Executive Officer and Chief Financial Officer, of the effectiveness of our “disclosure controls and procedures,” which are defined in Rule 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), as controls and other procedures of a company that are designed to ensure that the information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in U.S. Securities and Exchange Commission’s rules and forms, and that such information is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosure. Based upon that evaluation, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures were effective as of March 31, 2026.

Changes in Internal Control over Financial Reporting

Our management, including our Chief Executive Officer and Chief Financial Officer, has evaluated any changes in our internal control over financial reporting during the quarter ended March 31, 2026, to identify any change that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting. We have an ongoing deployment of a new enterprise resource planning system (“ERP”) as well as other related systems. We have made changes to our internal control over financial reporting to address the related processes and systems. We will continue to evaluate any further changes in our internal control over financial reporting over the course of the implementation of the new ERP and other related systems, which is scheduled to occur in phases over the next few years.

Limitations on the Effectiveness of Controls

A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Because of inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues, if any, within a company have been detected. Accordingly, our disclosure controls and procedures are designed to provide reasonable, not absolute, assurance that the objectives of our disclosure control system are met and, as set forth above, our Chief Executive Officer and Chief Financial Officer have concluded, based on their evaluation as of the end of the period covered by this report, that our disclosure controls and procedures were effective to provide reasonable assurance that the objectives of our disclosure control system were met.

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PART II.    OTHER INFORMATION

Item 1.      LEGAL PROCEEDINGS

For a description of our significant pending legal proceedings, please see Note 10. Commitments and Contingencies of the Notes to Condensed Consolidated Financial Statements included in Part I, Item 1 of this Quarterly Report on Form 10-Q.

Item 1A.     RISK FACTORS

In evaluating our business, you should carefully consider the following discussion of material risks, events and uncertainties that make an investment in us speculative or risky in addition to the other information in this Quarterly Report on Form 10-Q. A manifestation of any of the following risks and uncertainties could, in circumstances we may or may not be able to accurately predict, materially and adversely affect our business and operations, growth, reputation (including the commercial or scientific reputation of our products), prospects, product pipeline and sales, operating and financial results, financial condition, cash flows, liquidity and stock price. We note these factors for investors as permitted by the Private Securities Litigation Reform Act of 1995. It is not possible to predict or identify all such factors; our operations could also be affected by factors, events or uncertainties that are not presently known to us or that we currently do not consider to present significant risks to our operations. Therefore, you should not consider the following risks to be a complete statement of all the potential risks or uncertainties that we face. Moreover, some of the factors, events and contingencies discussed below may have occurred in the past, but the disclosures below are not representations as to whether or not the factors, events or contingencies have occurred in the past, and instead reflect our beliefs and opinions as to the factors, events or contingencies that could materially and adversely affect us in the future.

Product and Commercialization Risks

Certain of our products subject us to additional or heightened risks.

HIV

We receive a substantial portion of our revenue from sales of our products for the treatment and prevention of HIV infection. We may be unable to sustain or increase sales of our HIV products for any number of reasons, including market share gains by competitive products, including generics, or the inability to introduce new HIV medications necessary to remain competitive. In such case, we may need to scale back our operations, including our future drug development and spending on research and development (“R&D”) efforts.

Cell Therapy

Advancing a novel and personalized therapy, such as Yescarta or Tecartus, which are chimeric antigen receptor (“CAR”) T-cell therapies, creates significant challenges, including:

• developing and maintaining a robust and reliable process for engineering a patient’s T cells in our facilities and infusing them back into the patient;

• conditioning patients with chemotherapy in advance of administering our therapy, which may increase the risk of adverse side effects; and

• securing sufficient supply of other medications to manage side effects, such as tocilizumab and corticosteroids, which may not be available in sufficient quantities, may not adequately control the side effects and/or may have detrimental impacts on the efficacy of cell therapy.

In addition, future cell therapy products may be subject to a Risk Evaluation and Mitigation Strategy (“REMS”), which is a drug safety program that the U.S. Food and Drug Administration (“FDA”) may require for certain drugs. For example, until June 2025, Yescarta and Tecartus were subject to a REMS requirement to manage the risks of cytokine release syndrome and neurologic toxicities, which required a certification process for hospitals and clinics that dispense the products.

The use of engineered T cells as a potential cancer treatment is a recent development and may not be broadly accepted by physicians, patients, hospitals, cancer treatment centers, payers and others in the medical community. For example, in January 2024, FDA instituted a class labeling change for all approved CAR T-cell therapies, including a “boxed warning” about the possible risk of secondary T-cell malignancies in patients treated with CAR T-cell therapy. For challenges related to the reimbursement of Yescarta and Tecartus, see also “ Our existing products are subject to pricing and reimbursement pressures from government agencies and other third parties, including required discounts and rebates.”

We rely on third-party sites to collect patients’ white blood cells, known as apheresis centers, as well as shippers, couriers, and hospitals for the logistical collection of patients’ white blood cells and ultimate delivery of Yescarta and Tecartus to patients. Disruptions or difficulties at these vendors could result in product loss and regulatory action. Apheresis centers may

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also decline to participate in our quality certification process, or we may be unable to complete such certification in a timely manner or at all, which could delay or constrain our manufacturing and commercialization efforts.

We also face risks related to our in-house CAR T-cell therapy manufacturing facilities in California, Maryland and the Netherlands, spanning process development, vector manufacturing, clinical trial production and commercial product manufacturing. Quality, reliability and speed are critical in cell therapy manufacturing to quickly and safely deliver our cell therapies to patients. Any delays or quality issues with our manufacturing operations could adversely affect our business and damage our reputation. In addition, we may not be able to sufficiently increase manufacturing network capacity to meet growing demand.

Our success depends on developing and commercializing new products or expanding the indications for existing products.

If we are unable to launch commercially successful new products or new indications for existing products, including approval for earlier lines of therapy, our business will be adversely impacted. The launch of commercially successful products is necessary to grow our business, cover our substantial R&D expenses, and offset revenue losses when existing products lose market share due to factors such as competition and loss of patent exclusivity. There are many difficulties and uncertainties inherent in drug development and the introduction of new products. The product development cycle is characterized by significant investments of resources, long lead times and unpredictable outcomes due to the nature of developing medicines for human use. We expend significant time and resources on our product pipeline as well as on preparations for potential commercial launch without any assurance that we will recoup our investments or that our efforts will be commercially successful. A high rate of failure is inherent in the discovery and development of new products, and failure can occur at any point in the process, including late in the process after substantial investment. Such failures have had, and may have in the future, a negative impact on our business and financial results, including as a result of our inability to recover R&D, clinical trial, acquisition-related and other expenses incurred in connection with the development of and launch preparations for our product candidates. For example, we enter into commitments to purchase materials and supplies in anticipation of the potential manufacture and sale of new product candidates, and if the development, approval or launch of these product candidates is delayed or otherwise unsuccessful, we may experience excess inventory that needs to be written down, losses on firm commitments to purchase inventory, or other related costs and expenses resulting from such commitments.

Additionally, we face public attention and scrutiny related to the complex decisions we make concerning the pricing, global supply and distribution, allocation and intellectual property of our commercialized products as well as other factors that may contribute to patient access to our medicines, all of which may adversely affect our business and our corporate reputation.

We face challenges in accurately forecasting sales because of the difficulties in predicting demand for our products and fluctuations in purchasing patterns or wholesaler inventories.

We may be unable to accurately predict demand for our products as demand depends on a number of factors. If we do not accurately forecast demand or manufacture products at levels to align with actual demand, then we may experience product shortages or build excess inventory that may need to be written off. For example, product demand may be adversely affected if physicians do not see the benefit of our products. Additionally, uptake of new products may not materialize as expected, or at all in the case of unsuccessful product candidates. For example, Veklury sales generally reflect COVID-19 related rates and severity of infections and hospitalizations, as well as the availability, uptake and effectiveness of vaccines and alternative treatments for COVID-19, and future sales remain uncertain.

Additionally, the non-retail sector in the U.S., which includes government institutions such as state AIDS Drug Assistance Programs (“ADAPs”), the U.S. Department of Veterans Affairs, correctional facilities and large health maintenance organizations, tends to exhibit less predictable purchasing patterns, which results in quarter-over-quarter fluctuations that do not mirror actual patient demand for our products. Federal and state budget pressures, as well as the annual grant cycles for federal and state funds, may continue to contribute to variability in purchasing patterns. For example, in March 2026, the Florida ADAP implemented certain cost-containment measures, including removing Biktarvy from the formulary and imposing additional restrictions on access to Descovy. Other state ADAPs may also implement similar measures, including restricting eligibility and using waiting lists, which could adversely impact patient access and product sales. We expect to continue to experience fluctuations in the purchasing patterns of our non-retail customers. We have also observed variability in purchasing patterns in Europe as a result of cost containment measures in response to budgetary pressures. We believe these measures have caused some government agencies and other purchasers to reduce inventory of our products in the distribution channels, and we may continue to see this trend in the future.

We sell and distribute most of our products in the U.S. exclusively through the wholesaler/distributor channel. Historically, approximately 90% of our gross product sales in the U.S. have been to three wholesalers—Cardinal Health, Inc., Cencora, Inc. and McKesson Corporation—and their specialty distributor affiliates. The U.S. wholesalers and distributors with whom we have entered into inventory management agreements make estimates to determine end-user demand and may not be accurate in matching their inventory levels to actual end-user demand. As a result, changes in inventory levels held by those wholesalers and distributors can cause our operating results to fluctuate unexpectedly if our sales to these wholesalers and

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distributors do not match end-user demand. In addition, inventory is held at retail and specialty pharmacies and other non-wholesaler/distributor locations with whom we have no inventory management agreements and no control over buying patterns. Adverse changes in economic conditions, increased competition or other factors may cause retail and specialty pharmacies to reduce their inventories of our products, which would reduce their orders from wholesalers and distributors and, consequently, the wholesalers’ and distributors’ orders from us, even if end-user demand has not changed. In addition, we have observed that strong wholesaler/distributor and sub-wholesaler/distributor purchases of our products in the second half of the year typically results in inventory draw-down by wholesalers/distributors and sub-wholesalers/distributors in the subsequent first quarter. As inventory in the distribution channel fluctuates from quarter to quarter, we may continue to see fluctuations in our earnings and a mismatch between prescription demand for our products and our revenues.

We face significant competition from global pharmaceutical and biotechnology companies, specialized pharmaceutical firms and generic drug manufacturers.

New branded or generic products entering major markets affect our ability to maintain pricing and market share. Our products compete with other available products based primarily on efficacy, safety, tolerability, acceptance by doctors, ease of patient compliance, ease of use, price, insurance and other reimbursement coverage, distribution and marketing. A number of companies, including large pharmaceutical and biotechnology companies and specialized pharmaceutical firms acting either independently or together with other such companies, are pursuing the development of products and technologies that may be competitive with our existing products or research programs. Furthermore, academic institutions, government agencies and other public and private organizations conducting research may seek patent protection or may establish collaborative arrangements for competitive products or programs. We may be adversely impacted if any of these competitors gain market share as a result of new technologies, commercialization strategies or otherwise.

Our existing products are subject to pricing and reimbursement pressures from government agencies and other third parties, including required discounts and rebates.

Successful commercialization of our products depends, in part, on the availability and amount of third-party payer reimbursement for our products and related treatments and medical services in the markets where we sell our products. As our products mature, pricing pressures from private insurers and government payers often result in a reduction of the net product prices.

Legislative and regulatory actions affecting government prescription drug procurement and reimbursement programs occur relatively frequently. We may be adversely impacted by any such legislative and regulatory actions, though it is difficult to predict the impact, if any, on the use and reimbursement of our products.

In the U.S., the European Union (“EU”) and other significant or potentially significant markets for our products and product candidates, government authorities and third-party payers are increasingly attempting to limit or regulate the price of medical products and services. The volume of drug pricing-related legislation and administrative action has dramatically increased in recent years, including:

• U.S. Congress has enacted the Inflation Reduction Act of 2022 (“IRA”), which, among other changes, (1) requires the Department of Health and Human Services to “negotiate” Medicare prices for certain drugs (starting with 10 drugs in 2026, adding 15 drugs in 2027 and 2028, and adding 20 drugs in 2029 and subsequent years), which could also affect the Medicaid rebate obligations and the ceiling prices charged to covered entities under Section 340B of the Public Health Service Act (“340B”) if such prices are lower than the Medicaid Best Price and reduce the Average Sales Price and associated Medicare reimbursement rate for products reimbursed under Medicare Part B; (2) imposes an inflation-based rebate on Medicare Part B utilization starting in 2023 and Part D utilization beginning October 1, 2022; and (3) restructures the Medicare Part D benefit to cap out-of-pocket expenses for Part D beneficiaries beginning in 2024 and, effective January 1, 2025, increases Part D plans’ contributions in the catastrophic coverage phase and increases manufacturers’ discount contributions across coverage phases such that manufacturers must pay a 10% discount in the initial coverage phase and a 20% discount in the catastrophic phase on drugs utilized by all Part D beneficiaries, including low income subsidy patients. In January 2026, the Department of Health and Human Services selected Biktarvy for Maximum Fair Price determination under Medicaid, effective beginning in 2028, and more of our products may be selected in the future. We continue to evaluate the potential impact of the IRA on our business, but we anticipate that the negotiated Medicare price will be substantially lower than the price we currently charge in Medicare and may also lead to increased rebates to Medicaid agencies and potentially other segments and reduced ceiling prices charged to 340B covered entities. The Centers for Medicare and Medicaid Services (“CMS”) has issued a number of guidance documents and regulations governing certain aspects of the IRA, but it remains unclear how certain provisions of the IRA are being implemented due to lack of full transparency. Additional guidance, legislation or rulemaking may be issued that could change the scope or implementation of the IRA. In addition, multiple manufacturers and trade organizations have challenged the Medicare negotiation provisions of the IRA, and additional legal challenges may be filed in the future. While the full impact of the IRA on our business and the pharmaceutical

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industry remains uncertain at this time, we anticipate that the IRA will increase our payment obligations under the redesigned Part D discount program, limit the prices we can charge for our products, and increase the rebates we must provide government programs for our products, thereby reducing our profitability and negatively impacting our financial results.

• In July 2025, U.S. Congress enacted the One Big Beautiful Bill (“OBBB”) Act, which made several changes to the Medicaid program, such as imposing Medicaid work requirements and stricter eligibility and enrollment standards. Most of these policies will take effect in 2027. In addition, as of the end of 2025, enhanced subsidies for patient premiums are no longer available for Affordable Care Act (“ACA”) health insurance exchange plans, which has already contributed, and may continue to contribute, to decreases in patient enrollment in ACA exchange plans. These changes to Medicaid and ACA plans, individually or in combination, have reduced, and may continue to decrease, health insurance coverage for patients taking our medicines, potentially disrupting access to our medicines for some individuals and adversely impacting our financial results.

• The current U.S. Presidential administration has indicated that it plans to pursue additional policies aimed at lowering prescription drug costs. The administration has issued multiple executive orders and statements that illustrate the intent to require pharmaceutical manufacturers to offer U.S. prices based on most-favored-nation (“MFN”) lowest prices and that direct specified agency heads to take certain actions if significant progress towards such MFN prices is not achieved. In July 2025, the President sent letters to Gilead and other pharmaceutical manufacturers outlining the steps the President believes pharmaceutical manufacturers must take to bring down the prices of prescription drugs in the U.S. to match the MFN price offered in other developed nations. In December 2025, Gilead reached an agreement with the administration to (1) exclude Gilead branded pharmaceutical products and associated pharmaceutical ingredients from tariffs under Section 232 of the Trade Expansion Act of 1962, as amended (“Section 232”), for three years, provided Gilead further invests in manufacturing in the United States, (2) implement MFN prices in Medicaid for select existing products through the GENErating cost Reductions fOr U.S. Medicaid (GENEROUS) Model and MFN prices in the U.S. market for future launched products, (3) set a new direct-to-patient price for Epclusa and (4) return a portion of increased international revenues to the U.S. if the U.S. government is successful in increasing drug prices abroad. In addition, the administration announced several demonstration projects that would implement MFN pricing for certain Medicare Part B and Part D drugs through manufacturer inflation rebates on utilization by a portion of Medicare enrollees. The administration also recently called on Congress to enact legislation codifying MFN pricing. The specifics of these proposals and policies are evolving, and as a result, there is uncertainty as to how these and other potential legal and regulatory changes may impact our business.

• In April 2025, the U.S. Department of Commerce initiated an investigation pursuant to Section 232 to assess whether imports of pharmaceuticals and pharmaceutical ingredients into the United States pose a national security risk. Following this investigation, in April 2026, the U.S. President issued a Proclamation imposing 100% tariffs on patented pharmaceutical products and associated pharmaceutical ingredients, with such tariffs expected to take effect in the second half of 2026. The impact on Gilead remains uncertain at this time because the imposition of tariffs is subject to certain exemptions, as well as potential modifications to timing, scope and duration, and could be affected by broader tariffs and trade actions both within and outside the pharmaceutical industry. Even if it is determined that Gilead currently qualifies for an exemption, there can be no assurance that these or other tariffs will not apply to us in the future. Any such tariffs and related trade actions could increase our manufacturing costs, disrupt our supply chain and adversely affect our business competitiveness.

• Actions by the current U.S. Presidential administration to reorganize federal health agencies or reduce or pause funding for domestic and international HIV treatment and prevention programs and grants may adversely impact our business. Some of these initiatives may be subject to litigation or other challenge, increasing the uncertainty of their effects on our business.

• Many state legislatures are considering, or have already enacted, legislation that seeks to indirectly or directly regulate pharmaceutical drug pricing, such as requiring manufacturers to publicly report proprietary pricing information, creating drug affordability review boards, establishing drug payment limits, and encouraging the use of generic drugs. A finding that one of our products is unaffordable could lead to legislative action to designate an upper limit on the amount certain purchasers and payors can pay for our products. These initiatives and such other legislation may cause added pricing pressures on our products, and the resulting impact on our business is uncertain at this time.

• Many countries outside the U.S., including the EU member states, have established complex and lengthy procedures to obtain price approvals and coverage reimbursement and periodically review their pricing and reimbursement decisions. The outcome of these reviews is unpredictable and may adversely affect the pricing and reimbursement of our medical products in the EU. Price reductions in one EU member state could affect pricing in other member states, or in the U.S. pursuant to MFN pricing initiatives, and negatively impact our financial results.

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A substantial portion of our product sales is subject to significant discounts from list price, including rebates that we may be required to pay state Medicaid agencies and discounts provided to covered entities under 340B. Changes to the 340B program or the Medicaid program at the federal or state level could have a material adverse effect on our business. For example, changes to the calculation of rebates under the Medicaid program could substantially increase our Medicaid rebate obligations and decrease the prices we charge 340B-covered entities. In addition, the continued growth of the 340B program has had the unintended consequence of an increasingly out of scope percentage of sales at deeply discounted 340B prices due, in part, to pervasive violations of the program’s diversion and duplicate discount prohibitions. Detecting and remedying these program integrity violations is challenging.

In March 2022, we implemented a contract pharmacy integrity initiative for our branded hepatitis C virus (“HCV”) products. This integrity initiative does not involve any products from Asegua Therapeutics LLC. Our integrity initiative requires covered entities that enter into 340B bill to/ship to arrangements with contract pharmacies for our branded HCV products to provide claims level data for units dispensed from such contract pharmacies; covered entities without an in-house pharmacy that choose not to participate in the initiative can designate a single contract pharmacy for shipment. Certain manufacturers that have implemented other contract pharmacy integrity programs have received enforcement letters from the U.S. Department of Health and Human Services (“HHS”) asserting that those programs violate the 340B statute, have been referred to the HHS Office of Inspector General for assessment of civil monetary penalties, and have been subject to administrative dispute resolution proceedings brought on behalf of covered entities. Some of these manufacturers are challenging HHS’s position in litigation. The U.S. Courts of Appeals for the Third Circuit and the District of Columbia Circuit have held that HHS’s enforcement actions are unlawful, and a decision by the U.S. Court of Appeals for the Seventh Circuit is pending. A growing number of states have also enacted laws requiring manufacturers to provide 340B pricing through contract pharmacy arrangements, and additional states may adopt similar laws; we believe these laws, which are being challenged in ongoing litigation, are invalid but we have carved out covered entities in certain states from our integrity initiative while litigation challenging these laws proceeds. We also believe that our integrity initiative complies with the requirements of the 340B statute. However, additional legal or legislative developments with respect to the 340B program, including potential litigation with HHS or other stakeholders, may negatively impact our ability to implement or continue our integrity initiative.

In addition, standard reimbursement structures do not always adequately reimburse for innovative therapies. For example, CMS established a severity-adjusted diagnosis-related group (“DRG”) 018 for Medicare inpatient reimbursement of CAR T-cell products such as Yescarta and Tecartus. While the DRG has a significantly higher base payment amount than the prior DRG 016, the payment available may not be sufficient to reimburse some hospitals for their cost of care for patients receiving Yescarta and Tecartus. When reimbursement is not aligned well to account for treatment costs, Medicare beneficiaries may be denied access as this misalignment could impact the willingness of some hospitals to offer the therapy and of doctors to recommend the therapy. Additionally, in the EU, there are barriers to reimbursement in individual countries that could limit the uptake of Yescarta and Tecartus.

Moreover, we estimate the rebates we will be required to pay in connection with sales during a particular quarter based on claims data from prior quarters. In the U.S., actual rebate claims are typically made by payers one to three quarters in arrears. Actual claims and payments may vary significantly from our estimates.

We may experience adverse impacts resulting from the importation of our products from lower price markets or the distribution of illegally diverted or counterfeit versions of our products.

Prices for our products are based on local market economics and competition and sometimes differ from country to country. Our sales in countries with relatively higher prices may be reduced if products can be imported and resold into those countries from lower price markets. For example, in January 2024, FDA authorized Florida’s proposed program to import prescription drugs from Canada, subject to additional requirements, and U.S. sales may be adversely affected if Florida or other jurisdictions are able to implement such programs under the applicable regulatory framework. We have entered into agreements with generic drug manufacturers as well as licensing agreements with the Medicines Patent Pool, a United Nations-backed public health organization, which allow generic drug manufacturers to manufacture generic versions of certain of our products for distribution in certain low- and middle-income countries. We may be adversely affected if any generic versions of our products, whether or not produced and/or distributed under these agreements, are exported to the U.S., the EU or markets with higher prices.

In the EU, we are required to permit products purchased in one EU member state to be sold in another member state. Purchases of our products in member states where our selling prices are relatively low for resale in member states in which our selling prices are relatively high can affect the inventory level held by our wholesalers and can cause the relative sales levels in the various countries to fluctuate from quarter to quarter and not reflect the actual consumer demand in any given quarter.

Additionally, diverted products may be used in countries where they have not been approved and patients may source the diverted products outside the legitimate supply chain. These diverted products may be handled, shipped and stored improperly, which may adversely affect the quality and/or efficacy of the products and could harm patients and adversely impact us.

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We are also aware of the existence of various suppliers around the world that, without Gilead’s authorization, purport to source our products and generic versions of our products and sell them for use in countries where those products have not been approved. As a result, patients may be at risk of taking unapproved medications that may not be what they purport to be, may not have the potency they claim to have or may contain harmful substances, which could harm patients and adversely impact us.

Further, third parties have illegally distributed and sold, and may continue to illegally distribute and sell, illegally diverted and counterfeit versions of our medicines, which do not meet the rigorous quality standards of our manufacturing and supply chain. For example, as part of a U.S. civil enforcement lawsuit, we seized thousands of bottles of Gilead-labeled medication with counterfeit supply chain documentation. Our investigation revealed that unauthorized pharmaceutical distributors sold counterfeit Gilead medicine to independent pharmacies nationwide.

Illegally diverted and counterfeit versions of Gilead-branded medicines exist and may pose a serious risk to patient health and safety. Our actions to stop or prevent the distribution and sale of illegally diverted and counterfeit versions of our medicines around the world may be costly and unsuccessful, which may adversely affect patients and our reputation and business, including our product revenues and financial results.

Product Development and Supply Chain Risks

We face risks in our clinical trials, including the potential for unfavorable results, delays in anticipated timelines and disruption.

We are required to demonstrate the safety and efficacy of product candidates that we develop for each intended use through extensive preclinical studies and clinical trials. The results from these studies do not always accurately predict results in later, large-scale clinical trials. Even successfully completed large-scale clinical trials may not result in marketable products.

We face numerous risks and uncertainties with our clinical trials that could result in delays or prevent completion of the development and approval of our product candidates, including challenges in clinical trial protocol design, our ability to enroll patients in clinical trials, the possibility of unfavorable or inadequate trial results to support further development of our product candidates, including failure to meet a trial’s primary endpoint, safety issues arising from our clinical trials, and the need to modify or delay our clinical trials or to perform additional trials. For example, in January 2024, we announced that our Phase 3 EVOKE-01 study evaluating sacituzumab govitecan-hziy (“SG”) did not meet its primary endpoint of overall survival in previously treated metastatic non-small cell lung cancer (“NSCLC”), which resulted in us recording an impairment charge during the three months ended March 31, 2024 (for more information, see Note 7. Intangible Assets of the Notes to the Condensed Consolidated Financial Statements included in Part I, Item 1 of this Quarterly Report on Form 10-Q). In November 2025, we also announced that our Phase 3 ASCENT-07 study evaluating SG as a first-line treatment post-endocrine therapy in hormone receptor-positive, human epidermal growth factor receptor 2-negative (“HR+/HER2-”) metastatic breast cancer patients did not meet the primary endpoint of progression-free survival. While this information did not result in an impairment of the associated finite-lived intangible asset related to Trodelvy, potential future adverse changes in estimated Trodelvy revenues could negatively impact our results of operations and result in impairment charges in future periods.

As a result, we may be unable to successfully complete our clinical trials on our anticipated timelines, or at all. Based on trial results, it is possible that FDA and other regulatory authorities do not approve our product candidates, or that any market approvals include significant limitations on the products’ use. Additionally, products and indications approved under accelerated approval pathways may be subject to withdrawal where confirmatory studies are unsuccessful. In addition, clinical trials involving our commercial products can raise new safety issues for our existing products, which could adversely impact our business. Further, we have in the past and we may in the future make a strategic decision to discontinue development of our product candidates, including but not limited to situations where we believe commercialization will be difficult relative to other opportunities in our pipeline. Therefore, our product candidates may never be successfully commercialized, and we may be unable to recoup the significant R&D, clinical trial, acquisition-related and other expenses incurred. We expect to spend significant time and resources on our clinical trial activities without any assurance that we will recoup our investments or that our efforts will be commercially successful.

There are also risks associated with the use of third parties in our clinical trial activities. We extensively outsource our clinical trial activities and usually perform only a small portion of the start-up activities in-house. We rely on third-party contract research organizations (“CROs”) to perform most of our clinical studies, including document preparation, site identification, screening and preparation, pre-study visits, training, program management, patient enrollment, ongoing monitoring, site management and bioanalysis. Many important aspects of the services performed for us by the CROs are not within our direct control. If there is any dispute or disruption in our relationships with our CROs, including as a result of legislative or regulatory actions (such as the recently enacted BIOSECURE Act in the U.S.), our clinical trials and regulatory submissions may be delayed and our costs may increase. Moreover, in our regulatory submissions, we rely on the quality and validity of the clinical work performed by our CROs and investigators at the clinical trial sites. If any of their processes, methodologies or results were determined to be invalid, inadequate or in violation of Good Clinical Practices and related regulations, our own clinical data and results and related regulatory approvals may be adversely affected.

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We may not be able to obtain materials or supplies necessary to conduct clinical trials or to manufacture and sell our products, or we may face manufacturing difficulties, delays or interruptions, including at our third-party manufacturers and corporate partners, which could limit our ability to generate revenues.

We need access to certain materials and supplies to conduct our clinical trials and to manufacture and sell our products. If we are unable to purchase enough of these materials and supplies or find suitable alternatives in a timely manner, our development efforts for our product candidates may be delayed or our ability to manufacture and sell our products could be limited.

Suppliers of key components and materials must be named in the new drug/biologics application or marketing authorization application filed with the regulatory authority for any product candidate for which we are seeking marketing approval, and significant delays can occur if the qualification of a new supplier is required. Our products, which are manufactured and tested at our own facilities or by third-party contract manufacturing organizations (“CMOs”), third-party contract testing laboratories (“CTLs”) and corporate partners, are the result of complex, highly regulated manufacturing processes. We depend on CMOs, CTLs and corporate partners to perform manufacturing and testing activities effectively and on a timely basis for the majority of our active pharmaceutical ingredients and drug products. These third parties are independent entities subject to their own unique operational and financial risks that are out of our control. Some of our products and the materials that we utilize in our operations are manufactured and/or tested by only one supplier or at only one facility, which we may not be able to replace in a timely manner and on commercially reasonable terms, or at all. We and our CMOs, CTLs and corporate partners are subject to current Good Manufacturing Practices (“cGMP”), which are extensive regulations governing manufacturing processes, release and stability testing, recordkeeping and quality standards as defined by FDA and European Medicines Agency (“EMA”), as well as comparable regulations in other jurisdictions. Manufacturing operations are also subject to routine inspections by regulatory agencies. Even after a supplier is qualified by the regulatory authority, the supplier must continue to expend time, money and effort in the area of production and quality control to maintain full compliance with cGMP. If, as a result of these inspections, a regulatory authority determines that the equipment, facilities, laboratories or processes do not comply with applicable regulations and conditions of product approval, the regulatory authority may suspend the manufacturing operations. There can be no assurance that we or our CMOs, CTLs or other corporate partners will be able to remedy any deficiencies cited by FDA or other regulatory agencies in their inspections. Further, there is risk that regulatory agencies in other countries where marketing applications are pending will undertake similar additional reviews or apply a heightened standard of review, which could delay the regulatory approvals for products in those countries.

A significant portion of the raw materials and intermediates in the manufacturing of our products and product candidates are supplied by third-party suppliers, manufacturers and corporate partners outside of the U.S. As a result, any geopolitical or economic factors in a specific country or region, including any new, or changes in or interpretations of existing law, trade regulations, or compliance requirements (such as the recently enacted BIOSECURE Act) or tax that would limit or prevent third parties outside of the U.S. from supplying these materials could adversely affect our ability to manufacture and supply our products to meet market needs and have a material and adverse effect on our operating results. Such factors may also negatively impact our ability to supply our clinical trials and commercial product, which may result in the delay of our clinical trials and regulatory submissions, and could lead to regulatory delays, increased costs, and/or lost revenue.

Any adverse developments affecting or resulting from any single entity within our manufacturing operations or the operations of our CMOs, CTLs and corporate partners can result in shipment delays, inventory shortages, lot failures, product withdrawals or recalls or other interruptions in the development and commercial supply of our products, which may result in us not being able to generate sufficient quantities of clinical or commercial product to meet market demand and may cause delays in our clinical trials and applications for regulatory approval. We have incurred, and will continue to incur, inventory write-off charges and other expenses for products that fail to meet specifications and quality standards as well as changes we may adopt in our manufacturing strategy, and we may need to undertake costly remediation efforts or seek more costly manufacturing alternatives. Such developments could increase our manufacturing costs, cause us to lose revenues or market share and damage our reputation. Our business may be adversely affected if approval of any of our product candidates were delayed or if production of our products were interrupted.

Regulatory and Other Legal Risks

Our operations depend on compliance with complex FDA and comparable international regulations. Failure to obtain broad approvals on a timely basis or to maintain compliance, including if significant safety issues arise for our marketed products or our product candidates, could delay or halt commercialization of our products.

The products we develop must be approved for marketing and sale by regulatory authorities and, once approved, are subject to extensive regulation by FDA, EMA and comparable regulatory agencies in other countries. We have filed, and anticipate that we will continue to file, for marketing approval in additional countries and for additional indications and products. These and any future marketing applications we file may not be approved by the regulatory authorities on a timely basis, or at all, and changes or disruptions at FDA or other regulatory agencies, including as a result of budget cuts and

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employee layoffs, could impair the ability of these agencies to timely review and process our applications. Even if marketing approval is granted for our product candidates, there may be significant limitations on their use. We cannot state with certainty when or whether any of our product candidates under development will be approved or launched; whether we will be able to develop, license or acquire additional product candidates or products; or whether any products, once launched, will be commercially successful.

Further, how we manufacture and sell our products is subject to extensive regulation and review. For example, under FDA rules, we are often required to conduct post-approval clinical studies to assess a known serious risk, signals of serious risk or to identify an unexpected serious risk. In certain circumstances, we may be required to implement a Risk Evaluation and Mitigation Strategy program for our products, which could include a medication guide, patient package insert, a communication plan to healthcare providers, restrictions on distribution or use of a product and other elements FDA deems necessary to assure safe use of the drug. Discovery of previously unknown problems with our marketed products or product candidates, including serious safety, resistance or drug interaction issues, or problems with our manufacturing, safety reporting or promotional activities, may result in regulatory approvals being delayed, denied or granted with significant restrictions on our products, including limitations on or the withdrawal of the products from the market.

As additional studies are conducted after obtaining marketing approval for our products, and as our products are used over longer periods of time by many patients, including patients with underlying health problems or those taking other medicines, we expect to continue finding new issues related to safety, resistance or drug interactions. Any such issues may require changes to our product labels, such as additional warnings, contraindications or even narrowed indications, or the halt of product sales.

Regulatory authorities have been moving towards more active and transparent pharmacovigilance and are making greater amounts of stand-alone safety information and clinical trial data directly available to the public through websites and other means, such as periodic safety update report summaries, risk management plan summaries and various adverse event data. Safety information, without the appropriate context and expertise, may be misinterpreted and lead to misperception or legal action.

Failure to comply with these or other requirements imposed by FDA could result in significant civil monetary penalties, fines, suspensions of regulatory approvals, product recalls, seizure of products and criminal prosecutions.

We are impacted by evolving laws, regulations and legislative or regulatory actions applicable to the healthcare industry.

The healthcare industry is subject to various federal, state and international laws and regulations pertaining to drug approval, manufacturing, reimbursement, rebates, price reporting, healthcare fraud and abuse, and data privacy and security. In the U.S., these laws include anti-kickback and false claims laws, the Federal Food, Drug, and Cosmetic Act, laws and regulations relating to the Medicare and Medicaid programs and other federal and state programs, such as the Medicaid Rebate Statute and the 340B statute, laws that regulate written and verbal communications about our products, individual state laws relating to pricing and sales and marketing practices, the Health Insurance Portability and Accountability Act and other federal and state laws relating to the privacy and security of health or genetic information, including the Department of Justice Final Rule on Preventing Access to U.S. Sensitive Personal Data and Government-Related Data by Countries of Concern or Covered Persons, which impacts how and where clinical and other sensitive data is shared. Actual or alleged violations of these laws or any related regulations may be punishable by criminal and/or civil sanctions, including, in some instances, substantial fines, civil monetary penalties, exclusion from participation in federal and state healthcare programs, including Medicare, Medicaid and U.S. Department of Veterans Affairs and U.S. Department of Defense health programs, actions against executives overseeing our business and significant remediation measures, negative publicity or other consequences. These laws and regulations are broad in scope and subject to changing and evolving interpretations, including as a result of legal challenges, which may increase following the U.S. Supreme Court decision to overrule the Chevron doctrine, any of which could require us to incur substantial costs associated with compliance, alter one or more of our sales or marketing practices, adversely affect health insurance reimbursement of our products, or impact our ability to obtain or maintain regulatory approvals. The resulting impact on our business is uncertain and could be material. We may also become subject to new laws and regulations. For example, recently enacted and proposed legislation in the U.S., such as the BIOSECURE Act (which, among other things, prohibits U.S. executive agencies from contracting with, or expending loans or granting funds to, companies that use biotechnology equipment or services for certain activities from certain foreign-owned entities) and the ABC Safe Drug Act (which, among other things, could prohibit U.S. federal health care programs from purchasing drugs and drug ingredients manufactured in China), has the potential to adversely impact our ability to receive goods or services from such entities, including certain of which we use in connection with our clinical trials and our clinical and commercial manufacturing, which could increase the cost or limit the supply of material available to us, delay the procurement or supply of such material, delay or impact clinical trials and regulatory submissions, delay the launch of commercial products and adversely affect our financial condition and business prospects. In January 2026, the European Medicines Agency and FDA jointly established new artificial intelligence (“AI”) principles in drug development that provide broad guidance on AI use in evidence generation and monitoring across all phases of a medicine’s lifecycle - from early research and clinical trials to manufacturing and drug safety. These AI principles may lead to future regulatory guidance and requirements in various jurisdictions, which could affect the use

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of AI in our business.

In addition, government price reporting and payment regulations are complex, and we are continually assessing the methods by which we calculate and report pricing in accordance with these obligations. Our methodologies for calculations are inherently subject to assumptions and may be subject to review and challenge by various government agencies, which may disagree with our interpretation. If the government disagrees with our reported calculations, we may need to restate previously reported data and could be subject to additional financial and legal liability.

There also continues to be enhanced scrutiny of company-sponsored patient assistance programs, including co-pay assistance programs and manufacturer donations to third-party charities that provide such assistance. There has also been enhanced scrutiny by governments on reimbursement support offerings and other patient support offerings, clinical education programs and promotional speaker programs. Despite our training and compliance program, our internal control policies and procedures may not protect us from unlawful acts committed by our employees or agents. If we, or our agents and vendors, are deemed to have failed to comply with laws, regulations or government guidance in any of these areas, we could be subject to criminal or civil sanctions. Any similar violations by our competitors could also negatively impact our industry’s reputation and increase scrutiny over our business and our products.

For a description of our government investigations and related litigation, see Note 10. Commitments and Contingencies of the Notes to the Condensed Consolidated Financial Statements included in Part I, Item 1 of this Quarterly Report on Form 10-Q.

Our success depends to a significant degree on our ability to obtain and defend our patents and other intellectual property rights both domestically and internationally, and to operate without infringing upon the patents or other proprietary rights of third parties.

Patents and other proprietary rights are very important to our business. As part of our business strategy, we actively seek patent protection both in the U.S. and internationally covering our compounds, products and technology. Our success depends to a significant degree on our ability to obtain patents and licenses to patent rights, enforce our patents and defend against infringement of our patents and efforts to invalidate them, operate without infringing on the intellectual property of others, and preserve trade secrets and internal know-how.

Our pending patent applications and the patent applications filed by our collaborative partners may not be able to prevent third parties from developing compounds or products that are closely related to those which we have developed or are developing. In addition, certain countries do not provide effective mechanisms for enforcement of our patents, and third-party manufacturers may be able to sell generic versions of our products in those countries. Because patent applications are confidential for a period of time after filing, we may not know if our competitors have filed applications for technology covered by our pending applications or if we were the first to file an application directed toward the technology that is the subject of our patent applications. If competitors file patent applications covering our technology, we may have to participate in litigation, post-grant proceedings before the U.S. Patent and Trademark Office or other proceedings to determine the right to a patent or validity of any patent granted. Such litigation and proceedings are unpredictable and expensive, and could divert management attention from other operations, such that, even if we are ultimately successful, we may be adversely impacted.

Patents covering our existing compounds, products and technology, and those that we will likely file in the future, may not provide complete or adequate protection. Filing patent applications is a fact-intensive and complex process. We may file patent applications that ultimately do not result in patents or have patents that do not provide adequate protection for the related product. Patent term extensions may be available for products we are developing, but we cannot be certain we will obtain them. Future litigation or other proceedings regarding the enforcement or validity of our existing patents or any future patents could result in the invalidation of our patents or substantially reduce their protection. In addition, we may face criticism as a result of our legitimate use of the patent systems to protect our investments in new and useful innovations in medicine. Further, incentives and exclusivities relating to our products and product candidates may change in the future. We are aware that several countries are considering changes to support sharing how to make and use new inventions that could impact the current patent systems and protections for innovation. Any such changes could also impact the voluntary licensing patent programs that we establish for our products to support access to medicines.

Generic manufacturers have sought, and may continue to seek, FDA approval to market generic versions of our products through an abbreviated new drug application (“ANDA”), the application process typically used by manufacturers seeking approval of a generic drug. For a description of our ANDA litigation, see Note 10. Commitments and Contingencies of the Notes to the Condensed Consolidated Financial Statements included in Part I, Item 1 of this Quarterly Report on Form 10-Q. ANDA litigation and related settlement and license agreements, in some cases, may result in a loss of exclusivity for our patents sooner than we would otherwise expect. In addition, loss of exclusivity may be earlier than expected under these settlement and license agreements under certain circumstances. For example, settlement and license agreements with generic manufacturers typically include acceleration clauses that permit generic entry before the agreed-upon entry date in certain circumstances, and

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generic manufacturers may continue to challenge the patents protecting our products. The entry of generic versions of our products has, and may in the future, lead to market share and price erosion.

If we are found to infringe the valid patents of third parties, we may be required to pay significant monetary damages or we may be prevented from commercializing products or may be required to obtain licenses from these third parties. We may not be able to obtain alternative technologies or any required license on commercially reasonable terms or at all. If we fail to obtain these licenses or alternative technologies, we may be unable to develop or commercialize some or all of our products. For example, we are aware of patents and patent applications owned by other parties that such parties may claim to cover the use of our products and research activities. For a description of our pending patent litigation, see Note 10. Commitments and Contingencies of the Notes to the Condensed Consolidated Financial Statements included in Part I, Item 1 of this Quarterly Report on Form 10-Q.

Furthermore, we also rely on unpatented trade secrets and improvements, unpatented internal know-how and technological innovation. We protect these rights mainly through confidentiality agreements with our corporate partners, employees, consultants and vendors. We cannot be certain that these parties will comply with these confidentiality agreements, that we have adequate remedies for any breach or that our trade secrets, internal know-how or technological innovation will not otherwise become known or be independently discovered by our competitors. Under some of our R&D agreements, inventions become jointly owned by us and our corporate partner and in other cases become the exclusive property of one party. In certain circumstances, it can be difficult to determine who owns a particular invention and disputes could arise regarding those inventions. We could be adversely affected if our trade secrets, internal know-how, technological innovation or confidential information became known or independently discovered by competitors or if we enter into disputes over ownership of inventions.

We face potentially significant liability and increased expenses from litigation and government investigations relating to our products and operations.

We are involved in a number of litigation, investigation and other dispute-related matters that require us to expend substantial internal and financial resources. From time to time, these matters require us to pay significant monetary amounts, including royalty payments for past and future sales. We expect these matters will continue to require a high level of internal and financial resources for the foreseeable future. These matters have reduced, and are expected to continue to reduce, our earnings and require significant management attention.

In addition, the testing, manufacturing, marketing and use of our commercial products, as well as product candidates in development, involve substantial risk of product liability claims. These claims may be made directly by consumers, healthcare providers, pharmaceutical companies or others. We have limited insurance for product liabilities that may arise and claims may exceed our coverage.

For a description of our litigation, investigation and other dispute-related matters, see Note 10. Commitments and Contingencies of the Notes to the Condensed Consolidated Financial Statements included in Part I, Item 1 of this Quarterly Report on Form 10-Q. The outcome of such legal proceedings or any other legal proceedings that may be brought against us, the investigations or any other investigations that may be initiated and any other dispute-related matters, are inherently uncertain, and adverse developments or outcomes can result in significant expenses, monetary damages, penalties or injunctive relief against us.

Operational Risks

Our business has been, and may in the future be, adversely affected by outbreaks of epidemic, pandemic or contagious diseases.

Actual or threatened outbreaks of epidemic, pandemic or contagious diseases, or other public health emergencies, may significantly disrupt our global operations and adversely affect our business, financial condition and results of operations. As seen during the COVID-19 pandemic, outbreaks can result in global supply chain and logistics disruptions and distribution constraints. The impact of an outbreak or other public health crisis on our results of operations and financial condition would depend on numerous evolving factors, but could involve higher operating expenses, lower demand for our products as a result of governmental, business and individuals’ actions taken in response to such an event (including quarantines, travel restrictions and interruptions to healthcare services, which can impact enrollment in or operation of our clinical trials or limit patients’ ability or willingness to access and seek care), challenges associated with the safety of our employees and safe occupancy of our job sites, and financial market volatility and significant macroeconomic uncertainty in global markets. An outbreak or public health emergency also could amplify many of the other risks described throughout the “Risk Factors” section of this Quarterly Report on Form 10-Q.

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We face risks associated with our global operations.

Our global operations are accompanied by certain financial, political, economic and other risks, including those listed below:

• Foreign Currency Exchange: Because a significant percentage of our product sales is denominated in foreign currencies, primarily the Euro, we face exposure to adverse movements in foreign currency exchange rates. Overall, we are a net receiver of foreign currencies, and therefore, we benefit from a weaker U.S. dollar and are adversely affected by a stronger U.S. dollar. Our hedging program does not eliminate our exposure to currency fluctuations. We may be adversely impacted if the U.S. dollar appreciates significantly against certain currencies and our hedging program does not sufficiently offset the effects of such appreciation. For example, see “Foreign Currency Exchange Impact” in Part I, Item 2 of this Quarterly Report on Form 10-Q for a discussion of our exposure to movements in foreign currency exchange rates, primarily in the Euro, and the impacts from foreign currency exchange, net of hedges, for the three months ended March 31, 2026.

• Interest Rates and Inflation: We have interest-generating assets and interest-bearing liabilities, including our senior unsecured notes, term loan facility and revolving credit facility. Fluctuations in interest rates could expose us to increased financial risk. In addition, high inflation, such as what we have seen in recent years, has adversely impacted and may in the future adversely impact our business and financial results.

• Anti-Bribery: We are subject to the U.S. Foreign Corrupt Practices Act and similar worldwide anti-bribery laws that govern our international operations with respect to payments to government officials. Our international operations are heavily regulated and require significant interaction with foreign officials. We operate in parts of the world that have experienced governmental corruption to some degree. In certain circumstances, strict compliance with anti-bribery laws may conflict with local customs and practices or may require us to interact with doctors and hospitals, some of which may be state-controlled, in a manner that is different than local custom. It is possible that certain of our practices may be challenged under these laws. In addition, our internal control policies and procedures may not protect us from reckless or criminal acts committed by our employees and agents. Enforcement activities under anti-bribery laws could subject us to administrative and legal proceedings and actions, which could result in civil and criminal sanctions, including monetary penalties and exclusion from healthcare programs.

Other risks inherent in conducting a global business include:

• Restrictive government actions against our intellectual property and other assets such as nationalization, expropriation, the imposition of compulsory licenses or similar actions, including waiver of intellectual property protections.

• Changes in trade policies by the U.S. or foreign governments, which may result in protectionist measures, such as new or increased sanctions, tariffs (such as the country or industry-specific tariffs and related retaliatory actions implemented by the U.S. and other countries), embargoes, import and export licensing requirements or other trade restrictions, or the threat of such restrictions.

• Political instability or disruption in a geographic region where we operate, regardless of cause, including war, terrorism, social unrest and political changes, including in China, Russia, Ukraine, Israel, Iran and surrounding areas.

• Increasing use of social media platforms and modern technologies present new risks and challenges, and inappropriate or unauthorized use of these platforms can result in exposure of sensitive data or information and damage our brand and reputation.

Climate change and related natural disasters, as well as legal, regulatory, or market measures to address climate change, can negatively affect our business and operations.

Many of our operations and facilities, including those essential to our manufacturing, R&D and commercialization/distribution activities, are located in regions subject to natural or man-made disasters, such as climate change, earthquakes, hurricanes, rising sea levels and flooding, fires, extreme heat, drought or other extreme weather conditions, or efforts taken by third parties to prevent or mitigate such disasters, such as public safety power shutoffs and facility shutdowns. The severity and frequency of weather-related events has been amplified, and is expected to continue to be amplified, by climate change. Such natural disasters have caused, and in the future may cause, damage to and/or disrupt our operations, which may result in a material adverse effect on our business and financial results. Additionally, our corporate headquarters in Foster City and certain R&D and manufacturing facilities are located in California, a region that is seismically active and prone to wildfires. Our business continuity plans and contingencies, including periodic assessments of our natural disaster risk as part of our overall enterprise risk management program, may be insufficient, and a major earthquake or other natural disaster can result in significant recovery time and a prolonged interruption to our operational and business activities. We may be required to incur significant costs to remedy the effects of such natural disasters and to resume or restore our operations, which could adversely impact us.

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In addition, laws and regulations relating to climate change continue to evolve and may impose new or modified requirements on our operations. These requirements, which can differ across jurisdictions, subject us to many transition risks, including, for example, new or expanded carbon pricing or taxes, increased compliance costs, restrictions on greenhouse gas emissions, investment in new technologies, increased sustainability disclosures and transparency, investments in data gathering and reporting systems, upgrades of facilities to meet new building codes and the redesign of utility systems, which could increase the company’s operating costs, including the cost of electricity and energy. For example, many nations, particularly in the EU, have communicated plans to decarbonize their healthcare systems and achieve net zero emissions by 2050, which may require us to incur material costs in order to do so. Failure to sufficiently decarbonize or comply with climate-related requirements may impede our ability to operate in certain geographies and negatively affect our business. Regulatory efforts, both internationally and in the U.S., are evolving, including the international alignment of such efforts, and we cannot determine what final regulations will be enacted, modified or reversed or what their ultimate impact on our business will be. Our suppliers and third-party manufacturers and corporate partners similarly face these risks that could have an adverse effect on our business, and any disruption to their operations could have an adverse effect on our manufacturing and supply chain.

Our aspirations, goals and disclosures related to corporate responsibility matters expose us to numerous risks, including risks to our reputation and stock price.

We are subject to evolving and sometimes conflicting investor and other stakeholder expectations concerning corporate responsibility matters, such as environmental sustainability and climate change and related targets or performance. These expectations and standards are varied and evolving, and may be inconsistent with our current practices. It is not possible for our practices to satisfy all investors and stakeholders, and our reputation, our ability to attract or retain employees and our attractiveness as an investment, business partner or acquiror could be negatively impacted. For example, we face public attention and scrutiny regarding global patient access to our medicines, which may negatively impact our corporate reputation. Similarly, our pursuit of certain corporate responsibility practices, as well as our failure or perceived failure to pursue or fulfill our goals, targets and objectives, or to satisfy various reporting standards within the timelines we announce, or at all, could also similarly adversely impact us and expose us to government enforcement actions, stakeholder criticism or negative campaigns, and private litigation.

We depend on relationships with third parties for sales and marketing performance, technology, development, logistics and commercialization of products. Failure to maintain these relationships, poor performance by these companies or disputes with these third parties could negatively impact our business.

We rely on a number of collaborative relationships with third parties for our sales and marketing performance in certain territories. In some countries, we rely on international distributors for sales of certain of our products. Some of these relationships also involve the clinical development of these products by our partners. Reliance on collaborative relationships poses a number of risks, including the risk that:

• we are unable to control the resources our corporate partners devote to our programs or products;

• disputes may arise with respect to the ownership of rights to technology developed with our corporate partners;

• disagreements with our corporate partners could cause delays in, or termination of, the research, development or commercialization of product candidates or result in litigation or arbitration;

• contracts with our corporate partners may fail to provide significant protection or may fail to be effectively enforced if one of these partners fails to perform;

• our corporate partners have considerable discretion in electing whether to pursue the development of any additional products and may pursue alternative technologies or products either on their own or in collaboration with our competitors;

• our corporate partners with marketing rights may choose to pursue competing technologies or to devote fewer resources to the marketing of our products than they do to products of their own development; and

• our distributors and our corporate partners may be unable to pay us.

Given these risks, there is a great deal of uncertainty regarding the success of our current and future collaborative efforts. If these efforts fail, our product development or commercialization of new products could be delayed or revenues from products could decline.

Due to the specialized and technical nature of our business, the failure to attract, develop and retain highly qualified personnel could adversely impact us.

Our future success as a global business will depend in large part on our continued ability to attract, develop and retain highly qualified scientific, technical and management personnel, as well as personnel with expertise in clinical testing, governmental regulation and commercialization. Our ability to do so also depends in part on how well we maintain a strong

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workplace culture that is attractive to employees. In addition, competition for qualified personnel in the biopharmaceutical field is intense, and there is a limited pool of qualified potential employees to recruit. We face competition for personnel from other companies, universities, public and private research institutions, government entities and other organizations. Furthermore, changes to immigration and work authorization laws and regulations could make it more difficult for employees to work in or transfer to one of the jurisdictions in which we operate. Additionally, we periodically make adjustments, including to the size and composition of our workforce, to reflect our personnel needs in response to changing macroeconomic conditions, market opportunities, strategic priorities, management changes, acquisitions, cost levels and other internal and external considerations, which may adversely impact our workplace culture and ability to retain and incentivize employees.

Information system service interruptions or breaches, including significant cybersecurity incidents, could give rise to legal liability and regulatory action under data protection and privacy laws and adversely affect our business and operations.

We are dependent upon information technology systems, infrastructure and data. For example, our Kite Konnect platform is critical to maintain chain of identity and chain of custody for our cell therapies. The multitude and complexity of our computer systems make them inherently vulnerable to service interruption or destruction, including those caused by failures during system upgrades or implementations, user error, network or hardware failure, malicious intrusion and ransomware attack. Likewise, data privacy or cybersecurity incidents or breaches by employees or others, including the unauthorized use of AI tools, can result in the exposure of or misuse of sensitive data, including our intellectual property or trade secrets or the personal information of our employees, patients, customers or other business partners to unauthorized persons or to the public. Additionally, businesses which we have acquired, or may in the future acquire, may have undiscovered vulnerabilities in their information technology systems, which could increase our risk of cybersecurity incidents. If our information systems or third-party information systems on which we rely suffer severe damage, disruption or shutdown, including during upgrades or new implementations, and our business continuity plans do not effectively resolve the issues in a timely manner, we could experience delays in reporting our financial results, and we may lose revenue and profits as a result of our inability to timely manufacture, distribute, invoice and collect payments.

Cybersecurity attacks and incidents are increasing in their frequency, sophistication and intensity. Malicious actors seek to steal money, gain unauthorized access to, destroy or manipulate data, and disrupt operations, and some of their attacks may not be recognized or discovered until after a significant period of time well after initial entry into the environment, such as novel or zero-day attacks that are launched before patches are available and defenses can be readied. Malicious actors are also increasingly developing methods to avoid prevention, detection and alerting capabilities, including employing counter-forensic tactics making response activities more difficult. Such attacks and incidents include, for example, the deployment of harmful malware, exploitation of vulnerabilities, computer viruses, key loggers, ransomware, denial-of-service, social engineering and other means to affect service reliability and operations and threaten data confidentiality, integrity and availability. Recent developments in the threat landscape include the use of increasingly sophisticated and evolving AI and machine learning tools. Our business and technology partners face similar risks, and any security breach of their systems could adversely affect our security posture.

Like many companies, we have experienced and expect to continue to be the target of cybersecurity incidents, including data breaches and temporary service interruptions. When cybersecurity incidents occur, our policy is to respond and address them in accordance with applicable governmental regulations and other legal requirements, including our cybersecurity protocols. There can be no assurance that our efforts in response to cybersecurity incidents, as well as our investments to protect our information technology infrastructure and data, will shield us from significant losses, brand and reputational harm and potential liability or prevent any future interruption or breach of our systems. Additionally, it may take considerable time for us to investigate and evaluate the full impact of cybersecurity incidents, particularly for sophisticated attacks, which may inhibit our ability to provide prompt, full and reliable information about cybersecurity incidents to our customers, regulators and the public. Such cybersecurity incidents can cause the loss of critical or sensitive information, including personal information, and could give rise to legal liability and regulatory action under data protection and privacy laws. Financial, legal, business, or reputational losses may result from a cybersecurity incident or breach of our information technology systems.

Regulators globally are also imposing data privacy and security requirements, such as EU’s General Data Protection Regulation (“GDPR”) and other domestic data privacy and security laws, such as the California Consumer Privacy Act and the California Privacy Rights Act. These and other similar types of laws and regulations that have been or may be passed often include requirements with respect to personal information, and non-compliance with such laws may result in liability through private actions (subject to statutorily defined damages in the event of certain data breaches) and government enforcement. Other changes or new laws or regulations associated with the enhanced protection of personal information could greatly increase our cost of providing our products and services or even prevent us from offering certain services in jurisdictions in which we operate.

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Strategic and Financial Risks

We are subject to risks associated with engaging in business acquisitions, licensing arrangements, collaborations, options, equity investments, asset divestitures and other strategic transactions.

We have engaged in, and may in the future engage in, such transactions as part of our business strategy. We may not identify suitable transactions in the future and, if we do, we may not complete such transactions in a timely manner, on a cost-effective basis, or at all, including the possibility that a governmental entity or regulatory body may delay or refuse to grant approval for the consummation of the transaction. If we are successful in making an acquisition or closing a licensing arrangement or collaboration, the products, intellectual property and technologies that are acquired or licensed may not be successful or may require significantly greater resources and investments than anticipated. As required by U.S. generally accepted accounting principles, we conduct annual impairment testing of our goodwill and other indefinite-lived intangible assets in the fourth quarter or more frequently if events or changes in circumstances indicate that it is more likely than not that the assets are impaired. We have in the past and may in the future need to recognize impairment charges related to the products, intellectual property and technologies that are acquired or licensed as a result of such testing. For option structured deals, there is no assurance that we will elect to exercise our option right, and it is possible that disagreements, uncertainties or other circumstances may arise, including with respect to whether our option rights have been appropriately triggered, which may hinder our ability to realize the expected benefits. For equity investments in our strategic partners, such as in connection with our collaborations with Arcus Biosciences, Inc. and Galapagos NV, the value of our equity investments may fluctuate and decline in value. If we are not successful in the execution or implementation of these transactions, our financial condition, cash flows and results of operations may be adversely affected, and our stock price could decline.

We have paid substantial amounts of cash and incurred additional debt to finance our strategic transactions. Additional indebtedness and a lower cash balance could result in a downgrade of our credit ratings, limit our ability to borrow additional funds or refinance existing debt on favorable terms, increase our vulnerability to adverse economic or industry conditions, and reduce our financial flexibility to continue with our capital investments, stock repurchases and dividend payments. We may be adversely impacted by any failure to overcome these additional risks.

Our U.S. manufacturing and R&D investments may not achieve their intended benefits and could adversely affect our business, results of operations and cash flows.

We are undertaking significant multi‑year capital investments to expand our U.S. manufacturing capabilities and accelerate R&D, including our initiative to invest $32 billion in the U.S. through 2030. These investments are subject to numerous risks, including construction and commissioning delays, cost inflation, supply chain constraints, contractor performance, permitting and zoning challenges and the availability of skilled labor, and we may not complete our announced investments on a timely basis or at all. New or expanded facilities must meet cGMP and other regulatory requirements, are subject to FDA and other inspections, process validation and qualification, and their construction depends on third-party suppliers and partners whose performance we do not control. Any failure, delay, observation or remediation requirement could defer or limit production, increase costs or result in enforcement actions or other liabilities. We may not realize anticipated economic, employment, productivity, scale or innovation benefits, anticipated cost savings or future growth, and our reputation may be damaged, if these projects are delayed or unable to be completed in a cost-effective manner. This could also lead to underutilized assets, inventory write‑offs or asset impairments. Changes in laws or policies, including drug pricing reform, tax credits and incentives, environmental, health and safety standards, or tariff, trade and sourcing rules, could reduce expected returns on our investments or increase investment or operating costs. In addition, these initiatives require significant attention from management, capital expenditures and ongoing operating expenses and may increase variability in our margins and cash flows. Any of the foregoing could materially adversely affect our business, financial condition, results of operations, cash flows and reputation.

Changes in our effective income tax rate could reduce our earnings.

We are subject to income taxes in the U.S. and various foreign jurisdictions. Due to economic and political conditions, various countries are actively considering and have made changes to existing tax laws, and we cannot predict the form or timing of such changes. Our effective tax rates are affected by changes in the mix of earnings in countries with differing statutory tax rates, changes in the valuation of deferred tax assets and liabilities, the introduction of new taxes, and changes in tax laws, regulations, administrative practices and interpretations, including in the U.S., Germany and Ireland.

We are also subject to the examination of our tax returns and other tax matters by the U.S. Internal Revenue Service and tax authorities in various foreign jurisdictions. There are differing interpretations of tax laws and regulations and, as a result, significant disputes may arise with these tax authorities, including with respect to issues of the timing and amount of deductions and allocations of income among various tax jurisdictions. We may be adversely affected by the resolution of one or more of these exposures in any reporting period.

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Item 2.    UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS

Issuer Purchases of Equity Securities

In the first quarter of 2020, our Board of Directors authorized a $5.0 billion stock repurchase program (“2020 Program”) under which we started repurchases in December 2022. In the third quarter of 2025, our Board of Directors authorized a $6.0 billion stock repurchase program (“2025 Program”), which will commence upon the completion of the 2020 Program.

Both the 2020 Program and 2025 Program have no fixed expiration, and purchases under these programs may be made in the open market or in privately negotiated transactions, but the programs do not obligate us to repurchase any specific number of shares and may be amended, suspended or discontinued at any time.

The table below summarizes our stock repurchase activity for the three months ended March 31, 2026:

Total Number of Shares Purchased (in thousands) Average Price Paid per Share Total Number of Shares Purchased as Part of Publicly Announced Programs (in thousands) Approximate Dollar Value of Shares that May Yet Be Purchased Under the Programs (in millions)

January 1 - January 31, 2026 1,485  $ 125.79  1,447  $ 6,620

February 1 - February 28, 2026 966  $ 148.51  750  $ 6,508

March 1 - March 31, 2026 1,837  $ 145.81  870  $ 6,383

Total (1)

4,288  $ 139.48  3,067

_______________________________

(1)     The difference between the total number of shares purchased and the total number of shares purchased as part of a publicly announced program is due to shares of common stock withheld by us from employee restricted stock awards in order to satisfy applicable tax withholding obligations.

Item 3.      DEFAULTS UPON SENIOR SECURITIES

Not applicable.

Item 4.    MINE SAFETY DISCLOSURES

Not applicable.

Item 5.     OTHER INFORMATION

On February 25, 2026 , Daniel P. O’Day , our Chief Executive Officer and Chairman of our Board of Directors, adopted a trading plan intended to satisfy Rule 10b5-1(c) under the Exchange Act to sell up to 747,975 shares of our common stock through May 29, 2027 , subject to certain conditions.

Item 6.    EXHIBITS

Reference is made to the Exhibit Index included herein.

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Exhibit Index

The following exhibits are filed or furnished herewith or incorporated by reference:

Exhibit Number Description of Document Filed / Furnished / Incorporated by Reference

2.1 Agreement and Plan of Merger, dated February 11, 2024, among CymaBay Therapeutics, Inc., Registrant and Pacific Merger Sub, Inc. Incorporated herein by reference to an exhibit to our Form 8-K filed on February 12, 2024

2.2 Agreement and Plan of Merger, dated February 22, 2026, among Arcellx, Inc., Registrant and Ravens Sub, Inc. Incorporated herein by reference to an exhibit to our Form 8-K filed on February 23, 2026

3.1 Restated Certificate of Incorporation of Registrant Incorporated herein by reference to an exhibit to our Form 8-K filed on May 9, 2024

3.2 Amended and Restated Bylaws of Registrant Incorporated herein by reference to an exhibit to our Form 8-K filed on August 4, 2025

4.1 Reference is made to Exhibit 3.1 and Exhibit 3.2

4.2 Indenture related to Senior Notes, dated as of March 30, 2011, between Registrant and Wells Fargo, National Association, as Trustee Incorporated herein by reference to an exhibit to our Form 8-K filed on April 1, 2011

4.3 First Supplemental Indenture related to Senior Notes, dated as of March 30, 2011, between Registrant and Wells Fargo, National Association, as Trustee (including form of Senior Notes) Incorporated herein by reference to an exhibit to our Form 8-K filed on April 1, 2011

4.4 Second Supplemental Indenture related to Senior Notes, dated as of December 13, 2011, between Registrant and Wells Fargo, National Association, as Trustee (including Form of 2041 Note) Incorporated herein by reference to an exhibit to our Form 8-K filed on December 13, 2011

4.5 Third Supplemental Indenture related to Senior Notes, dated as of March 7, 2014, between Registrant and Wells Fargo, National Association, as Trustee (including Form of 2044 Note) Incorporated herein by reference to an exhibit to our Form 8-K filed on March 7, 2014

4.6 Fourth Supplemental Indenture related to Senior Notes, dated as of November 17, 2014, between Registrant and Wells Fargo, National Association, as Trustee (including Form of 2045 Note) Incorporated herein by reference to an exhibit to our Form 8-K filed on November 17, 2014

4.7 Fifth Supplemental Indenture, dated as of September 14, 2015, between Registrant and Wells Fargo Bank, National Association, as Trustee (including Form of 2026 Note, Form of 2035 Note and Form of 2046 Note) Incorporated herein by reference to an exhibit to our Form 8-K filed on September 14, 2015

4.8 Sixth Supplemental Indenture, dated as of September 20, 2016, between Registrant and Wells Fargo Bank, National Association, as Trustee (including Form of 2027 Note, Form of 2036 Note and Form of 2047 Note) Incorporated herein by reference to an exhibit to our Form 8-K filed on September 20, 2016

4.9 Eighth Supplemental Indenture, dated as of September 30, 2020, between the Registrant and Wells Fargo Bank, National Association, as Trustee (including Form of 2027 Note, Form of 2030 Note, Form of 2040 Note, and Form of 2050 Note) Incorporated herein by reference to an exhibit to our Form 8-K filed on September 30, 2020

4.1 Ninth Supplemental Indenture, dated as of September 14, 2023, between the Registrant and Computershare Trust Company, National Association, as successor to Wells Fargo Bank, National Association, as Trustee (including Form of 2033 Note and Form of 2053 Note) Incorporated herein by reference to an exhibit to our Form 8-K filed on September 14, 2023

4.11 Tenth Supplemental Indenture, dated as of November 20, 2024, between the Company and Computershare Trust Company, National Association, as successor to Wells Fargo Bank, National Association, as Trustee (including Form of 2029 Note, Form of 2035 Note, Form of 2054 Note and Form 2064 Note) Incorporated herein by reference to an exhibit to our Form 8-K filed on November 20, 2024

4.12 Description of Registrant’s Securities Incorporated herein by reference to an exhibit to our Form 10-K filed on February 25, 2020

10.1 * Gilead Sciences, Inc. 2004 Equity Incentive Plan, amended and restated May 10, 2017 Incorporated herein by reference to an exhibit to our Form 8-K filed on May 12, 2017

10.2 * Amendment No. 1 to Gilead Sciences, Inc. 2004 Equity Incentive Plan, amended and restated May 10, 2017 Incorporated herein by reference to an exhibit to our Form 10-K filed on February 25, 2021

10.3 * Gilead Sciences, Inc. 2022 Equity Incentive Plan, amended and restated April 30, 2026 Incorporated herein by reference to an exhibit to our Form 8-K filed on May 4, 2026

10.4 * Form of employee stock option agreement under 2004 Equity Incentive Plan (for grants made in 2011 through 2018) Incorporated herein by reference to an exhibit to our Form 10-Q filed on May 9, 2011

10.5 * Form of global employee stock option agreement under 2004 Equity Incentive Plan (for grants made in 2019) Incorporated herein by reference to an exhibit to our Form 10-Q filed on August 6, 2019

10.6 * Form of global employee stock option agreement under 2004 Equity Incentive Plan (4 year vest) (for grants made in 2019) Incorporated herein by reference to an exhibit to our Form 10-Q filed on November 5, 2019

10.7 * Form of global employee stock option agreement under 2004 Equity Incentive Plan (4 year vest) (for grants made in 2020) Incorporated herein by reference to an exhibit to our Form 10-Q filed on May 6, 2020

10.8 * Form of global employee stock option agreement under 2004 Equity Incentive Plan (4 year vest) (for grants made in 2021) Incorporated herein by reference to an exhibit to our Form 10-Q filed on May 6, 2021

10.9 * Form of global employee stock option agreement under 2004 Equity Incentive Plan (4 year vest) (for certain grants made in 2022) Incorporated herein by reference to an exhibit to our Form 10-Q filed on May 4, 2022

10.10 * Form of global employee stock option agreement under 2022 Equity Incentive Plan (4 year vest) (for certain grants made in 2022) Incorporated herein by reference to an exhibit to our Form 10-Q filed on August 8, 2022

10.11 * Form of global employee stock option agreement under 2022 Equity Incentive Plan (4 year vest) (for certain grants made in 2023) Incorporated herein by reference to an exhibit to our Form 10-Q filed on May 3, 2023

47

10.12 * Form of global employee stock option agreement under 2022 Equity Incentive Plan (4 year vest) (for certain grants made in 2024) Incorporated herein by reference to an exhibit to our Form 1 0-Q filed on May 8, 2024

10.13 * Form of global employee stock option agreement under 2022 Equity Incentive Plan (4 year vest) (for certain grants commencing in 2025) Incorporated herein by reference to an exhibit to our Form 10-Q filed on May 7, 2025

10.14 * Form of non-employee director stock option agreement under 2004 Equity Incentive Plan (for grants made in 2014 through 2018) Incorporated herein by reference to an exhibit to our Form 10-Q filed on August 4, 2014

10.15 * Form of non-employee director stock option agreement under 2004 Equity Incentive Plan (for grants made in 2019) Incorporated herein by reference to an exhibit to our Form 10-Q filed on August 6, 2019

10.16 * Form of non-employee director stock option agreement under 2004 Equity Incentive Plan (for grants made in 2020 and 2021)

Incorporated herein by reference to an exhibit to our Form 10-Q filed on August 6, 2020

10.17 * Form of non-employee director stock option agreement under 2022 Equity Incentive Plan (for grants made in 2022) Incorporated herein by reference to an exhibit to our Form 10-Q filed on August 8, 2022

10.18 * Form of non-employee director stock option agreement under 2022 Equity Incentive Plan (for grants made in 2023) Incorporated herein by reference to an exhibit to our Form 10-Q filed on August 4, 2023

10.19 * Form of non-employee director stock option agreement under 2022 Equity Incentive Plan (for grants made in 2024) Incorporated herein by reference to an exhibit to our Form 10-Q filed on August 8, 2024

10.20 * Form of non-employee director stock option agreement under 2022 Equity Incentive Plan (for grants commencing in 2025) Incorporated herein by reference to an exhibit to our Form 10-Q filed on August 7, 2025

10.21 * Form of performance share award agreement - TSR Goals (U.S.) under 2022 Equity Incentive Plan (for grants made in 2023)

Incorporated herein by reference to an exhibit to our Form 10-Q filed on May 3, 2023

10.22 * Form of performance share award agreement - TSR Goals (U.S.) under 2022 Equity Incentive Plan (for grants made in 2024) Incorporated herein by reference to an exhibit to our Form 10-Q filed on May 8, 2024

10.23 * Form of performance share award agreement - TSR Goals (U.S.) under 2022 Equity Incentive Plan (for grants commencing in 2025) Incorporated herein by reference to an exhibit to our Form 10-Q filed on May 7, 2025

10.24 * Form of performance share award agreement - Revenue Goals (U.S.) under 2022 Equity Incentive Plan (for grants made in 2023) Incorporated herein by reference to an exhibit to our Form 10-Q filed on May 3, 2023

10.25 * Form of performance share award agreement - Revenue Goals (U.S.) under 2022 Equity Incentive Plan (for grants made in 2024) Incorporated herein by reference to an exhibit to our Form 10-Q filed on May 8, 2024

10.26 * Form of performance share award agreement – Adjusted EPS Growth Goals (U.S.) under 2022 Equity Incentive Plan (for grants made in 2025) Incorporated herein by reference to an exhibit to our Form 10-Q filed on May 7, 2025

10.27 * Form of performance share award agreement – Adjusted EPS Growth Goals (U.S.) under 2022 Equity Incentive Plan (for grants commencing in 2026) Filed herewith

10.28 * Form of global employee restricted stock unit issuance agreement under 2004 Equity Incentive Plan (4 year vest) (for certain grants made in 2022)

Incorporated herein by reference to an exhibit to our Form 10-Q filed on May 4, 2022

10.29 * Form of global employee restricted stock unit agreement under 2022 Equity Incentive Plan (4 year vest) (for certain grants made in 2022)

Incorporated herein by reference to an exhibit to our Form 10-Q filed on August 8, 2022

10.30 * Form of global employee restricted stock unit agreement under 2022 Equity Incentive Plan (4 year vest) (for grants made in 2023) Incorporated herein by reference to an exhibit to our Form 10-Q filed on May 3, 2023

10.31 * Form of global employee restricted stock unit agreement under 2022 Equity Incentive Plan (4 year vest) (for grants made in 2024)

Incorporated herein by reference to an exhibit to our Form 10-Q filed on May 8, 2024

10.32 * Form of global employee restricted stock unit agreement under 2022 Equity Incentive Plan (4 year vest) (for grants commencing in 2025) Incorporated herein by reference to an exhibit to our Form 10-Q filed on May 7, 2025

10.33 * Form of non-employee director restricted stock unit agreement under 2022 Equity Incentive Plan (for grants made in 2024) Incorporated herein by reference to an exhibit to our Form 10-Q filed on August 8, 2024

10.34 * Form of non-employee director restricted stock unit agreement under 2022 Equity Incentive Plan (for grants commencing in 2025) Incorporated herein by reference to an exhibit to our Form 10-Q filed on August 7, 2025

10.35 * Gilead Sciences, Inc. 2018 Equity Incentive Plan, amended and restated April 7, 2020 Incorporated herein by reference to an exhibit to our Form 10-Q filed on August 6, 2020

10.36 * Gilead Sciences, Inc. Employee Stock Purchase Plan, amended and restated January 25, 2023 Incorporated herein by reference to an exhibit to our Form 8-K filed on May 5, 2023

10.37 * Gilead Sciences, Inc. 2005 Deferred Compensation Plan, amended and restated April 19, 2016 Incorporated herein by reference to an exhibit to our Form 10-Q filed on August 6, 2019

10.38 * Gilead Sciences, Inc. Severance Plan, amended and restated July 29, 2025 Incorporated herein by reference to an exhibit to our Form 10-Q filed on November 7, 2025

10.39 * Gilead Sciences, Inc. Corporate Annual Incentive Plan, amended and restated August 1, 2023 Incorporated herein by reference to an exhibit to our Form 10-Q filed on November 7, 2023

10.40 * Offer Letter between Registrant and Daniel O’Day, dated November 30, 2018 Incorporated herein by reference to an exhibit to our Form 8-K filed on December 10, 2018

48

10.41 * Stock option agreement for Daniel O’Day under 2004 Equity Incentive Plan Incorporated herein by reference to an exhibit to our Form 10-Q filed on August 6, 2019

10.42 * Form of restricted stock unit issuance agreement for Daniel O’Day (in 2019) under 2004 Equity Incentive Plan Incorporated herein by reference to an exhibit to our Form 10-Q filed on August 6, 2019

10.43 * Offer Letter between Registrant and Johanna Mercier, dated May 21, 2019 Incorporated herein by reference to an exhibit to our Form 10-Q filed on August 6, 2019

10.44 * Global stock option agreement for Johanna Mercier (in 2019) under 2004 Equity Incentive Plan Incorporated herein by reference to an exhibit to our Form 10-Q filed on May 6, 2020

10.45 * Restricted stock unit issuance agreement for Johanna Mercier (for Performance Objectives in 2019-2020) under 2004 Equity Incentive Plan Incorporated herein by reference to an exhibit to our Form 10-Q filed on May 6, 2020

10.46 * Offer Letter between Registrant and Dietmar Berger, dated November 14, 2024 Filed herewith

10.47 * Global restricted stock unit agreement for Dietmar Berger under 2022 Equity Incentive Plan (3 year vest) Filed herewith

10.48 * Offer Letter between Registrant and Deborah Telman, dated June 2, 2022 Incorporated herein by reference to an exhibit to our Form 10-Q filed on May 3, 2023

10.49 * Global stock option agreement for Deborah Telman under 2022 Equity Incentive Plan Incorporated herein by reference to an exhibit to our Form 10-Q filed on May 3, 2023

10.50 * Global restricted stock unit issuance agreement for Deborah Telman under 2022 Equity Incentive Plan (3 year vest) Incorporated herein by reference to an exhibit to our Form 10-Q filed on May 3, 2023

10.51 * Global restricted stock unit issuance agreement for Deborah Telman under 2022 Equity Incentive Plan (4 year vest) Incorporated herein by reference to an exhibit to our Form 10-Q filed on May 3, 2023

10.52 * Severance and General Release Agreement between Registrant and Deborah Telman, dated November 16, 2025 Incorporated herein by reference to an exhibit to our Form 10-K filed on February 24, 2026

10.53 * Form of Indemnity Agreement entered into between Registrant and its directors and executive officers Incorporated herein by reference to an exhibit to our Form S-1 (No. 33-55680), as amended

10.54 * Form of Employee Proprietary Information and Invention Agreement entered into between Registrant and certain of its officers and key employees Incorporated herein by reference to an exhibit to our Form S-1 (No. 33-55680), as amended

10.55 * Form of Employee Proprietary Information and Invention Agreement entered into between Registrant and certain of its officers and key employees (revised September 2006) Incorporated herein by reference to an exhibit to our Form 10-K filed on February 27, 2007

10.56 *,+ Amendment Agreement, dated October 25, 1993, between Registrant, the Institute of Organic Chemistry and Biochemistry (IOCB) and Rega Stichting v.z.w. (REGA), together with the following exhibits: the License Agreement, dated December 15, 1991, between Registrant, IOCB and REGA (the 1991 License Agreement); the License Agreement, dated October 15, 1992, between Registrant, IOCB and REGA (the October 1992 License Agreement); and the License Agreement, dated December 1, 1992, between Registrant, IOCB and REGA (the December 1992 License Agreement) Incorporated herein by reference to an exhibit to our Form 10-K for our fiscal year ended March 31, 1994

10.57 *,+ Amendment Agreement between Registrant and IOCB/REGA, dated December 27, 2000, amending the 1991 License Agreement and the December 1992 License Agreement Incorporated herein by reference to an exhibit to our Form 10-K filed on March 20, 2001

10.58 + Sixth Amendment Agreement to the License Agreement, between IOCB/REGA and Registrant, dated August 18, 2006, amending the October 1992 License Agreement and the December 1992 License Agreement Incorporated herein by reference to an exhibit to our Form 10-Q filed on November 6, 2006

10.59 + Seventh Amendment Agreement to the License Agreement, between IOCB/REGA and Registrant, dated July 1, 2013, amending the October 1992 License Agreement and the December 1992 License Agreement Incorporated herein by reference to an exhibit to our Form 10-Q filed on October 31, 2013

10.60 + Exclusive License Agreement by and between Registrant (as successor to Triangle Pharmaceuticals, Inc.), Glaxo Group Limited, The Wellcome Foundation Limited, Glaxo Wellcome Inc. and Emory University, dated May 6, 1999 Incorporated herein by reference to an exhibit to Triangle Pharmaceuticals, Inc.’s Form 10-Q/A filed on November 3, 1999

10.61 + Royalty Sale Agreement by and among Registrant, Emory University and Investors Trust & Custodial Services (Ireland) Limited, solely in its capacity as Trustee of Royalty Pharma, dated July 18, 2005 Incorporated herein by reference to an exhibit to our Form 10-Q filed on November 4, 2005

10.62 + Amended and Restated License Agreement by and between Registrant, Emory University and Investors Trust & Custodial Services (Ireland) Limited, solely in its capacity as Trustee of Royalty Pharma, dated July 21, 2005 Incorporated herein by reference to an exhibit to our Form 10-Q filed on November 4, 2005

10.63 ++ Amended and Restated EVG License Agreement by and between Japan Tobacco Inc. and Registrant, dated November 29, 2018 Incorporated herein by reference to an exhibit to our Form 10-K/A filed on April 18, 2019

10.64 ++ Master Agreement by and between Registrant, Gilead Sciences K.K. and Japan Tobacco Inc., dated November 29, 2018 Incorporated herein by reference to an exhibit to our Form 10-K/A filed on April 18, 2019

10.65 + Amended and Restated Collaboration Agreement by and among Registrant, Gilead Sciences Ireland UC (formerly Gilead Sciences Limited) and Janssen R&D Ireland, dated December 23, 2014 Incorporated herein by reference to an exhibit to our Form 10-K filed on February 25, 2015

10.66 + License Agreement by and among Kite Pharma, Inc., Cabaret Biotech Ltd. and Dr. Zelig Eshhar, dated December 12, 2013 Incorporated herein by reference to an exhibit to Kite Pharma, Inc.’s Form S-1/A (No. 333-196081) filed on June 17, 2014

10.67 ++ Option, License and Collaboration Agreement by and between Galapagos NV and Registrant, dated July 14, 2019 Incorporated herein by reference to an exhibit to our Form 10-Q filed on November 5, 2019

31.1 Certification of Chief Executive Officer, as required by Rule 13a-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934, as amended

Filed herewith

49

31.2 Certification of Chief Financial Officer, as required by Rule 13a-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934, as amended

Filed herewith

32 Certifications of Chief Executive Officer and Chief Financial Officer, as required by Rule 13a-14(b) or Rule 15d-14(b) and Section 1350 of Chapter 63 of Title 18 of the United States Code (18 U.S.C. §1350)

Furnished herewith

101.INS XBRL Instance Document - The instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document Filed herewith

101.SCH Inline XBRL Taxonomy Extension Schema Document Filed herewith

101.CAL Inline XBRL Taxonomy Extension Calculation Linkbase Document Filed herewith

101.DEF Inline XBRL Taxonomy Extension Definition Linkbase Document Filed herewith

101.LAB Inline XBRL Taxonomy Extension Label Linkbase Document Filed herewith

101.PRE Inline XBRL Taxonomy Extension Presentation Linkbase Document Filed herewith

104 Cover Page Interactive Data File, formatted in Inline XBRL (included as Exhibit 101)

*    Management contract or compensatory plan or arrangement.

+    Certain confidential portions of this Exhibit were omitted by means of marking such portions with an asterisk (the Mark). This Exhibit has been filed separately with the Secretary of U.S. Securities and Exchange Commission without the Mark pursuant to Registrant’s Application Requesting Confidential Treatment under Rule 24b-2 under the Securities Exchange Act of 1934, as amended.

++    Certain portions of this Exhibit were omitted by means of marking such portions with the Mark because the identified portions are (i) private or confidential and (ii) not material.

50

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

GILEAD SCIENCES, INC.

(Registrant)

Date: May 7, 2026 /s/ DANIEL P. O’DAY

Daniel P. O ’ Day

Chairman and Chief Executive Officer

(Principal Executive Officer)

Date: May 7, 2026 /s/ ANDREW D. DICKINSON

Andrew D. Dickinson

Chief Financial Officer

(Principal Financial Officer)

51

打开原文

免疫组合带动艾伯维上调指引

重要性3/5 中

ABBV一手季报提供产品销售、利润口径和全年指引,直接相关且证据密度高;发布时间距日报较远,优先级受时效性限制。

中文摘要

核心结论

艾伯维(AbbVie,NYSE: ABBV)04/29(未给出具体时刻)披露,2026年第一季度净收入150.02亿美元,同比增长12.4%;免疫学组合与神经科学组合保持两位数增长,公司将全年调整后稀释每股收益指引上调至14.08—14.28美元。

重要性评级

评级:3/5(中)

这是ABBV的公司一手季报,产品收入和全年指引信息完整;但发布于04/29,距07/11日报已有时滞,适合用作业绩与产品结构的背景依据。

关键事实

  • 调整后稀释每股收益为2.65美元,同比增长7.7%;按GAAP(美国通用会计准则)口径为0.39美元,同比下降45.8%,其中已购研发及里程碑费用造成每股0.41美元不利影响。
  • 免疫学组合收入72.90亿美元,同比增长16.4%;Skyrizi收入44.83亿美元,同比增长30.9%,Rinvoq收入21.19亿美元,同比增长23.3%,Humira收入6.88亿美元,同比下降38.6%。
  • 神经科学组合收入28.75亿美元,同比增长26.0%;Botox Therapeutic收入10.09亿美元,同比增长16.5%,Vraylar收入9.05亿美元,同比增长18.4%,Ubrelvy与Qulipta合计收入6.35亿美元。
  • 肿瘤组合收入16.31亿美元,同比下降0.2%;Imbruvica收入5.56亿美元,同比下降24.7%,Venclexta收入7.70亿美元,同比增长15.7%。
  • 医美组合收入11.86亿美元,同比增长7.6%;Botox Cosmetic收入6.68亿美元,同比增长20.2%,Juvederm收入2.32亿美元,同比增长0.4%。
  • 公司向FDA(美国食品药品监督管理局)提交Skyrizi用于克罗恩病皮下诱导治疗及Rinvoq用于重度斑秃的新适应症申请;FDA已批准Venclexta与acalabrutinib用于初治慢性淋巴细胞白血病的固定疗程联合方案。
  • trenibotulinumtoxinE的生物制品许可申请收到FDA完整回复函,监管方要求补充生产工艺资料,公告称未提出安全性、有效性疑虑,也未要求新增临床试验。
  • 公司宣布在北卡罗来纳州达勒姆建设18.5万英亩制造园区,投资14亿美元;另计划在伊利诺伊州北芝加哥建设两座原料药设施,投资3.8亿美元。

作者观点与证据

公告管理层将增长归因于重点增长产品和研发管线进展,证据是分产品销售额、同比增速及上调后的全年调整后每股收益区间。该材料来自公司新闻稿,收入和会计数据具备一手披露性质;对于临床项目、审批进度和长期增长的表述含有前瞻性与公司宣传口径,仍受研发、竞争、知识产权及监管风险影响。

与相关标的的关系

ABBV的直接关联在于收入结构继续由Skyrizi、Rinvoq和神经科学产品扩张支撑,同时Humira和Imbruvica的收入下滑仍在压低部分成熟业务。上调全年调整后每股收益指引提供了管理层对全年经营预期的正式更新;完整回复函与后续回复进度则关系到trenibotulinumtoxinE的上市节奏。

时效性与限制

文章发布于04/29(未给出具体时刻),检索于美东时间07/11 07:41(UTC+8 07/11 19:41)。季报属于可核验的一手历史资料,但其后可能已有新的销售、监管或竞争信息;调整后指标排除了若干指定项目,需与GAAP口径及后续定期报告一并阅读。

后续跟踪

  • Skyrizi、Rinvoq、Humira的季度销售增速及免疫学组合份额变化。
  • 神经科学与医美产品的收入延续性,尤其是Botox Therapeutic、Botox Cosmetic、Ubrelvy和Qulipta。
  • Skyrizi克罗恩病皮下诱导治疗、Rinvoq斑秃适应症及trenibotulinumtoxinE的FDA进展。
  • 已购研发、里程碑费用、制造投资与全年调整后每股收益指引的后续变化。
原文
AbbVie Reports First-Quarter 2026 Financial Results

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April 29, 2026

AbbVie Reports First-Quarter 2026 Financial Results

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  • Reports First-Quarter Diluted EPS of $0.39 on a GAAP Basis, a Decrease of 45.8 Percent; Adjusted Diluted EPS of $2.65, an Increase of 7.7 Percent; These Results Include an Unfavorable Impact of $0.41 Per Share Related to Acquired IPR&D and Milestones Expense
  • Delivers First-Quarter Net Revenues of $15.002 Billion, an Increase of 12.4 Percent on a Reported Basis or 10.3 Percent on an Operational Basis
  • First-Quarter Global Net Revenues from the Immunology Portfolio Were $7.290 Billion, an Increase of 16.4 Percent on a Reported Basis, or 14.3 Percent on an Operational Basis; Global Skyrizi Net Revenues Were $4.483 Billion; Global Rinvoq Net Revenues Were $2.119 Billion; Global Humira Net Revenues Were $688 Million
  • First-Quarter Global Net Revenues from the Neuroscience Portfolio Were $2.875 Billion, an Increase of 26.0 Percent on a Reported Basis, or 24.3 Percent on an Operational Basis; Global Vraylar Net Revenues Were $905 Million; Global Botox Therapeutic Net Revenues Were $1.009 Billion; Combined Global Ubrelvy and Qulipta Net Revenues Were $635 Million; Global Vyalev Net Revenues Were $201 Million
  • First-Quarter Global Net Revenues from the Oncology Portfolio Were $1.631 Billion, a Decrease of 0.2 Percent on a Reported Basis, or 3.0 Percent on an Operational Basis; Global Venclexta Net Revenues Were $770 Million; Global Imbruvica Net Revenues Were $556 Million; Global Elahere Net Revenues Were $198 Million
  • First-Quarter Global Net Revenues from the Aesthetics Portfolio Were $1.186 Billion, an Increase of 7.6 Percent on a Reported Basis, or 5.1 Percent on an Operational Basis; Global Botox Cosmetic Net Revenues Were $668 Million; Global Juvederm Net Revenues Were $232 Million
  • Raises 2026 Adjusted Diluted EPS Guidance Range from $13.96 - $14.16 to $14.08 - $14.28, which Includes an Unfavorable Impact of $0.41 Per Share Related to Acquired IPR&D and Milestones Expense Incurred Year-To-Date Through the First Quarter 2026

NORTH CHICAGO, Ill. , April 29, 2026 / PRNewswire / -- AbbVie (NYSE:ABBV) announced financial results for the first quarter ended March 31, 2026.

"We are off to an excellent start in 2026, with first-quarter results exceeding our expectations. AbbVie's key growth drivers continue to deliver strong performance and support our enhanced full-year outlook," said Robert A. Michael, chairman and chief executive officer, AbbVie. "We are also generating exciting data and advancing numerous programs across all stages of development. Our pipeline progress and solid business fundamentals position AbbVie for robust long-term growth."

First-Quarter Results

  • Worldwide net revenues were $15.002 billion, an increase of 12.4 percent on a reported basis, or 10.3 percent on an operational basis.
  • Global net revenues from the immunology portfolio were $7.290 billion, an increase of 16.4 percent on a reported basis, or 14.3 percent on an operational basis.
  • Global Skyrizi net revenues were $4.483 billion, an increase of 30.9 percent on a reported basis, or 29.2 percent on an operational basis.
  • Global Rinvoq net revenues were $2.119 billion, an increase of 23.3 percent on a reported basis, or 20.2 percent on an operational basis.
  • Global Humira net revenues were $688 million, a decrease of 38.6 percent on a reported basis, or 40.3 percent on an operational basis.
  • Global net revenues from the neuroscience portfolio were $2.875 billion, an increase of 26.0 percent on a reported basis, or 24.3 percent on an operational basis.
  • Global Vraylar net revenues were $905 million, an increase of 18.4 percent.
  • Global Botox Therapeutic net revenues were $1.009 billion, an increase of 16.5 percent on a reported basis, or 14.9 percent on an operational basis.
  • Global Ubrelvy net revenues were $339 million, an increase of 41.4 percent on a reported basis, or 41.2 percent on an operational basis.
  • Global Qulipta net revenues were $296 million, an increase of 53.6 percent on a reported basis, or 51.3 percent on an operational basis.
  • Global Vyalev net revenues were $201 million.
  • Global net revenues from the oncology portfolio were $1.631 billion, a decrease of 0.2 percent on a reported basis, or 3.0 percent on an operational basis.
  • Global Venclexta net revenues were $770 million, an increase of 15.7 percent on a reported basis, or 9.7 percent on an operational basis.
  • Global Imbruvica net revenues were $556 million, a decrease of 24.7 percent.
  • Global Elahere net revenues were $198 million, an increase of 10.7 percent on a reported basis, or 8.3 percent on an operational basis.
  • Global net revenues from the aesthetics portfolio were $1.186 billion, an increase of 7.6 percent on a reported basis, or 5.1 percent on an operational basis.
  • Global Botox Cosmetic net revenues were $668 million, an increase of 20.2 percent on a reported basis, or 17.0 percent on an operational basis.
  • Global Juvederm net revenues were $232 million, an increase of 0.4 percent on a reported basis, or a decrease of 2.9 percent on an operational basis.
  • On a GAAP basis, the gross margin ratio in the first quarter was 71.9 percent. The adjusted gross margin ratio was 83.6 percent.
  • On a GAAP basis, selling, general and administrative (SG&A) expense was 23.9 percent of net revenues. The adjusted SG&A expense was 22.7 percent of net revenues.
  • On a GAAP basis, research and development (R&D) expense was 16.5 percent of net revenues. The adjusted R&D expense was 15.1 percent of net revenues.
  • Acquired IPR&D and milestones expense was 5.0 percent of net revenues.
  • On a GAAP basis, the operating margin ratio in the first quarter was 26.6 percent. The adjusted operating margin ratio was 40.8 percent.
  • Net interest expense was $645 million.
  • On a GAAP basis, the tax rate in the quarter was 32.9 percent. The adjusted tax rate was 15.4 percent.
  • Diluted earnings per share (EPS) in the first quarter was $0.39 on a GAAP basis. Adjusted diluted EPS, excluding specified items, was $2.65. These results include an unfavorable impact of $0.41 per share related to acquired IPR&D and milestones expense.

Note: "Operational" comparisons are presented at constant currency rates that reflect comparative local currency net revenues at the prior year's foreign exchange rates.

Recent Events

  • AbbVie announced it submitted an application to the U.S. Food and Drug Administration (FDA) seeking approval for Skyrizi (risankizumab) for subcutaneous (SC) induction in the treatment of adult patients with moderately to severely active Crohn's disease (CD). AbbVie expects an approval decision later this year, which would offer adult CD patients an additional option for induction of Skyrizi. The submission is supported by data from the Phase 3 AFFIRM study evaluating the efficacy and safety of Skyrizi SC induction in adult patients with moderately to severely active CD. In the study, Skyrizi achieved superiority for the co-primary and ranked secondary endpoints at week 12 for induction delivered by SC injection versus placebo. The safety profile of Skyrizi SC induction was consistent with its known profile in CD, with no new safety risks observed.
  • AbbVie announced it submitted an application to the FDA for a new indication for Rinvoq (upadacitinib) in the treatment of adult and adolescent patients with severe alopecia areata (AA). The submission is supported by data from the Phase 3 UP-AA clinical program in which Rinvoq achieved the primary endpoint as well as key secondary endpoints.
  • At the 2026 American Academy of Dermatology (AAD) Annual Meeting, AbbVie presented key data reinforcing the company's leadership in advancing standards of care across immune-mediated skin diseases. Presentations showcased the efficacy and safety of Skyrizi in psoriatic disease, real-world evidence of minimal disease activity and clinical long-term safety outcomes of Rinvoq in atopic dermatitis (AD), as well as Phase 3 data for Rinvoq in vitiligo and AA. The company also presented data highlighting the safety and efficacy of new and emerging products in AbbVie's aesthetics portfolio, including trenibotulinumtoxinE.
  • AbbVie announced the FDA approved a supplemental new drug application (sNDA) for the combination regimen of Venclexta (venetoclax) and acalabrutinib for the treatment of previously untreated adult patients with chronic lymphocytic leukemia (CLL). This approval establishes the Venclexta and acalabrutinib combination as the first all-oral, fixed-duration regimen for previously untreated CLL, offering patients the potential of time off treatment. The approval is supported by data from the Phase 3 AMPLIFY trial.
  • At the Society of Gynecologic Oncology (SGO) Annual Meeting, AbbVie presented Phase 2 data for Elahere in platinum-sensitive ovarian cancer (PSOC). Results from the IMGN853-0420 trial showed a more than 60 percent objective response rate (ORR) and consistent safety findings with Elahere plus carboplatin followed by a continuation of Elahere monotherapy in patients with folate receptor alpha (FRα)-expressing PSOC. These findings highlight Elahere's potential expanding role across the ovarian cancer treatment continuum.
  • AbbVie announced it received a Complete Response Letter (CRL) from the FDA regarding the Biologics License Application (BLA) for trenibotulinumtoxinE (trenibotE), a first-in-class botulinum neurotoxin serotype E with a rapid onset of effect and short duration. In its letter, the FDA requested additional information about manufacturing processes. The CRL does not identify any safety or efficacy concerns for trenibotE and does not request additional clinical studies. AbbVie is confident that it can address the FDA's comments promptly and expects to submit a thorough response in the coming months.
  • AbbVie announced positive topline results from the multiple ascending dose (MAD) part of its Phase 1 study evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of ABBV-295, in adults with a mean body mass index (BMI) of less than 30 kg/m 2 . In the study, ABBV-295 treatment showed clinically meaningful body weight reduction at week 12 (weekly dosing) and week 13 (every other week and monthly dosing after week 5). ABBV-295 also demonstrated a favorable tolerability profile at all evaluated dose levels, with no serious adverse events reported. Data support continued development of ABBV-295 as a potentially differentiated treatment for chronic weight management, with a non-incretin-based mechanism of action.
  • AbbVie announced a $1.4 billion investment to build a 185-acre pharmaceutical manufacturing campus in Durham, North Carolina. The state-of-the-art campus will integrate advanced manufacturing and laboratory technologies with artificial intelligence (AI) to support the production of AbbVie's immunology, neuroscience and oncology medicines.
  • AbbVie announced a $380 million investment to build two new active pharmaceutical ingredient (API) manufacturing facilities at its North Chicago, Illinois, campus. These state-of-the-art facilities will integrate advanced manufacturing technologies with AI to support the production of AbbVie's next-generation neuroscience and obesity medications.
  • AbbVie announced the opening of the Allergan Medical Institute (AMI) Training Center in Austin, Texas. This location marks the third U.S. AMI Training Center opened in the last year, reflecting AbbVie's continued investment in aesthetics training and education.

Full-Year 2026 Outlook

AbbVie is raising its adjusted diluted EPS guidance for the full year 2026 from $13.96 - $14.16 to $14.08 - $14.28, which includes an unfavorable impact of $0.41 per share related to acquired IPR&D and milestones expense incurred year-to-date through the first quarter 2026. The company's 2026 adjusted diluted EPS guidance excludes any impact from acquired IPR&D and milestones that may be incurred beyond the first quarter of 2026, as both cannot be reliably forecasted.

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, neuroscience and oncology – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on LinkedIn , Facebook , Instagram , X and YouTube .

Conference Call

AbbVie will host an investor conference call today at 8:00 a.m. Central Time to discuss our first-quarter performance. The call will be webcast through AbbVie's Investor Relations website at investors.abbvie.com . An archived edition of the call will be available after 11:00 a.m. Central Time.

Non-GAAP Financial Results

Financial results for 2026 and 2025 are presented on both a reported and a non-GAAP basis. Reported results were prepared in accordance with generally accepted accounting principles in the United States (GAAP) and include all revenue and expenses recognized during the period. Non-GAAP results adjust for certain non-cash items and for factors that are unusual or unpredictable, and exclude those costs, expenses, and other specified items presented in the reconciliation tables later in this release. AbbVie's management believes non-GAAP financial measures provide useful information to investors regarding AbbVie's results of operations and assist management, analysts and investors in evaluating the performance of the business. Non-GAAP financial measures should be considered in addition to, and not as a substitute for, measures of financial performance prepared in accordance with GAAP.

Forward-Looking Statements

Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to AbbVie's industry, the impact of global macroeconomic factors, such as economic downturns or uncertainty, international conflict, trade disputes, tariffs and other uncertainties and risks associated with global business operations. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2025 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its Quarterly Reports on Form 10-Q and in other documents that AbbVie subsequently files with the Securities and Exchange Commission that update, supplement or supersede such information. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

Media:

Investors:

Gabby Tarbert

Liz Shea

(224) 244-0111

(847) 935-2211

Todd Bosse

(847) 936-1182

Jeffrey Byrne

(847) 938-2923

AbbVie Inc.

Key Product Revenues

Quarter Ended March 31, 2026

(Unaudited)

% Change vs. 1Q25

Net Revenues (in millions)

Reported

Operational a

U.S.

Int'l.

Total

U.S.

Int'l.

Total

Int'l.

Total

NET REVENUES

$10,969

$4,033

$15,002

9.9 %

19.9 %

12.4 %

11.4 %

10.3 %

Immunology

5,537

1,753

7,290

13.4

26.9

16.4

17.3

14.3

Skyrizi

3,775

708

4,483

29.3

39.8

30.9

28.0

29.2

Rinvoq

1,405

714

2,119

15.1

43.4

23.3

32.6

20.2

Humira

357

331

688

(52.0)

(12.3)

(38.6)

(17.4)

(40.3)

Neuroscience

2,459

416

2,875

24.7

34.4

26.0

21.8

24.3

Vraylar

902

3

905

18.2

67.6

18.4

58.9

18.4

Botox Therapeutic

842

167

1,009

16.5

16.3

16.5

6.7

14.9

Ubrelvy

330

9

339

41.7

29.2

41.4

22.9

41.2

Qulipta

250

46

296

45.4

>100.0

53.6

99.7

51.3

Vyalev

89

112

201

>100.0

98.3

>100.0

76.9

>100.0

Other Neuroscience

46

79

125

(38.9)

(1.5)

(19.6)

(11.7)

(24.8)

Oncology

882

749

1,631

(14.1)

23.4

(0.2)

15.7

(3.0)

Venclexta

341

429

770

9.2

21.4

15.7

10.1

9.7

Imbruvica b

332

224

556

(37.4)

7.2

(24.7)

7.2

(24.7)

Elahere

160

38

198

(2.9)

>100.0

10.7

>100.0

8.3

Epkinly c

25

58

83

22.1

89.3

62.0

81.8

57.6

Other Oncology

24

24

n/m

n/m

n/m

n/m

n/m

Aesthetics

704

482

1,186

9.8

4.5

7.6

(1.5)

5.1

Botox Cosmetic

371

297

668

25.8

13.9

20.2

7.1

17.0

Juvederm Collection

85

147

232

12.2

(5.3)

0.4

(10.3)

(2.9)

Other Aesthetics

248

38

286

(8.4)

(15.7)

(9.4)

(20.5)

(10.1)

Other Key Products

816

179

995

28.5

3.0

23.0

(7.9)

20.7

Mavyret

183

168

351

28.3

2.4

14.5

(8.6)

8.6

Creon

361

361

1.8

n/m

1.8

n/m

1.8

Linzess

272

11

283

96.9

12.7

91.5

3.0

90.9

a    "Operational" comparisons are presented at constant currency rates that reflect comparative local currency net revenues at the prior year's foreign exchange rates.

b    Reflects profit sharing for Imbruvica international revenues.

c    Epkinly U.S. revenues reflect profit sharing. International revenues reflect product revenues as well as profit sharing from certain international territories.

n/m = not meaningful

AbbVie Inc.

Consolidated Statements of Earnings

(Unaudited)

(in millions, except per share data)

First Quarter

Ended March 31

2026

2025

Net revenues

$     15,002

$     13,343

Cost of products sold

4,218

4,002

Selling, general and administrative

3,578

3,293

Research and development

2,472

2,067

Acquired IPR&D and milestones

744

248

Total operating costs and expenses

11,012

9,610

Operating earnings

3,990

3,733

Interest expense, net

645

627

Other expense, net

2,306

1,445

Earnings before income tax expense

1,039

1,661

Income tax expense

342

372

Net earnings

697

1,289

Net earnings attributable to noncontrolling interest

2

3

Net earnings attributable to AbbVie Inc.

$         695

$      1,286

Diluted earnings per share attributable to AbbVie Inc.

$        0.39

$        0.72

Adjusted diluted earnings per share a

$        2.65

$        2.46

Weighted-average diluted shares outstanding

1,774

1,772

a  Refer to the Reconciliation of GAAP Reported to Non-GAAP Adjusted Information for further details.

AbbVie Inc.

Reconciliation of GAAP Reported to Non-GAAP Adjusted Information

(Unaudited)

1.     Specified items impacted results as follows:

Quarter Ended March 31, 2026

(in millions, except per share data)

Earnings

Diluted

Pre-tax

After-tax a

EPS

As reported (GAAP)

$         1,039

$           695

$          0.39

Adjusted for specified items:

Intangible asset amortization

1,748

1,498

0.85

Change in fair value of contingent consideration

2,387

2,325

1.31

Other

395

193

0.10

As adjusted (non-GAAP)

$         5,569

$         4,711

$          2.65

a  Represents net earnings attributable to AbbVie Inc. Specified items reflect the impact of applicable statutory tax rates.

Reported GAAP earnings and adjusted non-GAAP earnings for the three months ended March 31, 2026 included acquired IPR&D and milestones expense of $744

million on a pre-tax and $738 million on an after-tax basis, representing an unfavorable impact of $0.41 to both diluted EPS and adjusted diluted EPS.

2.     The impact of the specified items by line item was as follows:

Quarter Ended March 31, 2026

(in millions)

Cost of

products

sold

SG&A

R&D

Other

expense,

net

As reported (GAAP)

$    4,218

$    3,578

$    2,472

$    2,306

Adjusted for specified items:

Intangible asset amortization

(1,748)

Change in fair value of contingent consideration

(2,387)

Other

(8)

(177)

(204)

(6)

As adjusted (non-GAAP)

$    2,462

$    3,401

$    2,268

$      (87)

3.     The adjusted tax rate for the first quarter of 2026 was 15.4 percent, as detailed below:

Quarter Ended March 31, 2026

(dollars in millions)

Pre-tax

earnings

Income taxes

Tax rate

As reported (GAAP)

$         1,039

$           342

32.9 %

Specified items

4,530

514

11.3 %

As adjusted (non-GAAP)

$         5,569

$           856

15.4 %

AbbVie Inc.

Reconciliation of GAAP Reported to Non-GAAP Adjusted Information

(Unaudited)

1.     Specified items impacted results as follows:

Quarter Ended March 31, 2025

(in millions, except per share data)

Earnings

Diluted

Pre-tax

After-tax a

EPS

As reported (GAAP)

$         1,661

$         1,286

$          0.72

Adjusted for specified items:

Intangible asset amortization

1,858

1,574

0.89

Change in fair value of contingent consideration

1,518

1,477

0.83

Other

62

33

0.02

As adjusted (non-GAAP)

$         5,099

$         4,370

$          2.46

a  Represents net earnings attributable to AbbVie Inc. Specified items reflect the impact of applicable statutory tax rates.

Reported GAAP earnings and adjusted non-GAAP earnings for the three months ended March 31, 2025 included acquired IPR&D and milestones expense of $248

million on a pre-tax and $238 million on an after-tax basis, representing an unfavorable impact of $0.13 to both diluted EPS and adjusted diluted EPS.

2.     The impact of the specified items by line item was as follows:

Quarter Ended March 31, 2025

(in millions)

Cost of

products

sold

SG&A

R&D

Other

expense,

net

As reported (GAAP)

$   4,002

$   3,293

$   2,067

$   1,445

Adjusted for specified items:

Intangible asset amortization

(1,858)

Change in fair value of contingent consideration

(1,518)

Other

(28)

(13)

(16)

(5)

As adjusted (non-GAAP)

$   2,116

$   3,280

$   2,051

$     (78)

3.     The adjusted tax rate for the first quarter of 2025 was 14.2 percent, as detailed below:

Quarter Ended March 31, 2025

(dollars in millions)

Pre-tax

earnings

Income taxes

Tax rate

As reported (GAAP)

$         1,661

$           372

22.4 %

Specified items

3,438

354

10.3 %

As adjusted (non-GAAP)

$         5,099

$           726

14.2 %

SOURCE AbbVie

The information in the press releases on these pages was factually accurate on the date of publication. These press releases remain on AbbVie's website for historical purposes only. AbbVie assumes no duty to update the information to reflect subsequent developments. Readers should not rely upon the information in these pages as current or accurate after their publication dates.

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打开原文

默沙东增长与并购负担

重要性4/5 高

美国证券交易委员会季度原始披露直接覆盖MRK收入、核心产品、并购费用和融资,但数据截至03/31,较当日日报已有滞后。

中文摘要

核心结论

MRK(默沙东)2026年第一季度销售额为162.86亿美元,同比增长5%;肿瘤、心肺和动物保健的增长抵消了疫苗、糖尿病及感染性疾病业务下滑。同期因收购Cidara确认90亿美元研发费用,归母净亏损42.40亿美元;这项一次性资产收购费用与主营销售增长需分开阅读。

重要性评级

评级:4/5(高)。这是默沙东向美国证券交易委员会提交的季度原始披露,直接覆盖MRK的产品收入、并购支出、融资与监管定价风险;发布时间为05/04(未给出具体时刻),对07/11日报属于滞后但仍有较高证据价值的公司基本面材料。

关键事实

  • 2026年第一季度全球销售额162.86亿美元,较2025年同期155.29亿美元增长5%;剔除汇率影响后增长3%。美国销售增长8%,国际销售按固定汇率口径下降3%。
  • Keytruda(帕博利珠单抗抗PD-1肿瘤药)及皮下制剂Keytruda Qlex合计销售80.34亿美元,同比增长12%;美国端约有2.5亿美元增长来自批发商采购时点,另受净价和需求提升支持。
  • 疫苗业务的Gardasil/Gardasil 9(人乳头瘤病毒疫苗)销售10.69亿美元,低于上年同期的13.27亿美元;中国销售3.90亿美元,低于7.02亿美元,是国际收入承压的具体背景之一。
  • Winrevair(肺动脉高压药)销售5.25亿美元,较上年同期2.80亿美元增长;Welireg(肾癌等适应症药物)销售1.99亿美元,同比增长45%。
  • 默沙东1月以92亿美元收购Cidara,其候选药MK-1406处于Phase 3(三期临床);其中90亿美元计入研发费用,令研发支出升至125.92亿美元,并造成42.40亿美元归母净亏损、每股亏损1.72美元。
  • 公司3月同意以约67亿美元收购Terns Pharmaceuticals,拟取得白血病候选药TERN-701;文件预计交割时确认约58亿美元研发费用,并预计在交割后对2026年剩余期间每股收益产生约0.12美元负面影响。
  • 截至03/31,现金及投资为68.07亿美元,低于2025年末的155.21亿美元;总债务占负债和权益比重38.2%。公司4月安排最多60亿美元、期限364天的延迟提款贷款,拟用于Terns收购部分现金对价。

作者观点与证据

材料为默沙东向美国证券交易委员会提交的季度报告,核心证据是未经审计的合并财务报表、分产品销售表及管理层经营讨论。公司将销售增长归因于Keytruda、Welireg、Winrevair和动物保健,疫苗下滑主要归因于Gardasil/Gardasil 9;这些归因属于管理层披露,销售金额与同比数据可由报表直接核对。对Terns交割、费用和每股影响的表述均为公司预期,尚受交割条件及后续执行影响。

与相关标的的关系

  • MRK:Keytruda仍是最大收入来源,合计80.34亿美元销售额和12%增长直接决定肿瘤业务的当期表现。
  • MRK:Cidara与Terns交易把资金投入流感预防及肿瘤研发管线,同时带来大额一次性研发费用、现金下降和短期融资需求。
  • MRK:美国《通胀削减法案》下,Januvia已于2026年生效政府定价,Janumet系列将于2027年生效;公司预计Keytruda可能在2027年被选中,定价或于2029年生效,构成中长期收入与利润率变量。

时效性与限制

报告发布于05/04(未给出具体时刻),数据截止03/31;截至07/11已不能代表最新季度经营。原文为公司法定披露,财务数据证据强,但产品需求解释、并购交割预期和监管影响均带有管理层前瞻性判断。归档文本仅供受保护的内部报告阅读,且本摘要未包含其后发生的季度更新或监管进展。

后续跟踪

  • Keytruda及Keytruda Qlex的销售增速、批发采购时点影响和国际市场定价变化。
  • Gardasil/Gardasil 9在中国及其他国际市场的需求恢复或继续下滑。
  • Terns收购的交割、融资结构及实际研发费用确认。
  • Cidara的MK-1406三期临床进展,以及美国药品定价谈判对Januvia、Janumet、Lenvima和Keytruda的后续影响。
原文
Merck Quarterly Report for the Quarter Ended March 31, 2026

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended March 31, 2026

OR

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from ____ to ____

Commission File No.  1-6571

Merck & Co., Inc.

(Exact name of registrant as specified in its charter)

New Jersey 22-1918501

(State or other jurisdiction of incorporation)

(I.R.S. Employer Identification No.)

126 East Lincoln Avenue

Rahway New Jersey 07065

(Address of principal executive offices) (zip code)

(Registrant’s telephone number, including area code) (908)   740-4000

Not Applicable

(Former name, former address and former fiscal year, if changed since last report.)

Securities Registered pursuant to Section 12(b) of the Act:

Title of each class Trading Symbol(s) Name of each exchange on which registered

Common Stock ($0.50 par value) MRK New York Stock Exchange

1.875% Notes due 2026 MRK/26 New York Stock Exchange

3.250% Notes due 2032

MRK/32

New York Stock Exchange

2.500% Notes due 2034 MRK/34 New York Stock Exchange

1.375% Notes due 2036 MRK 36A New York Stock Exchange

3.500% Notes due 2037

MRK/37

New York Stock Exchange

3.700% Notes due 2044

MRK/44

New York Stock Exchange

3.750% Notes due 2054

MRK/54

New York Stock Exchange

Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.   Yes    ☒    No   ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).   Yes    ☒    No   ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company.

Large accelerated filer ☒ Accelerated filer ☐

Non-accelerated filer ☐ Smaller reporting company ☐

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).  Yes  ☐   No  ☒

The number of shares of common stock outstanding as of the close of business on April 30, 2026: 2,469,824,415

Table of Contents

Page No.

PART I FINANCIAL INFORMATION

3

Item 1. Financial Statements

3

Condensed Consolidated Statement of Operations

3

Condensed Consolidated Statement of Comprehensive (Loss) Income

3

Condensed Consolidated Balance Sheet

4

Condensed Consolidated Statement of Cash Flows

5

Notes to Condensed Consolidated Financial Statements

6

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

29

Item 3. Quantitative and Qualitative Disclosures about Market Risk

42

Item 4. Controls and Procedures

42

Cautionary Factors That May Affect Future Results

42

PART II OTHER INFORMATION

43

Item 1. Legal Proceedings

43

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds

43

Item 5. Other Information

43

Item 6. Exhibits

44

Signatures

45

Part I - Financial Information

Item 1. Financial Statements

MERCK & CO., INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENT OF OPERATIONS

(Unaudited, $ in millions except per share amounts)

Three Months Ended

March 31,

2026 2025

Sales $ 16,286   $ 15,529

Costs, Expenses and Other

Cost of sales 4,195   3,419

Selling, general and administrative 2,700   2,552

Research and development 12,592   3,621

Restructuring costs 195   69

Other (income) expense, net 138   ( 35 )

19,820   9,626

(Loss) Income Before Taxes

( 3,534 ) 5,903

Income Tax Provision

709   818

Net (Loss) Income

( 4,243 ) 5,085

Less: Net (Loss) Income Attributable to Noncontrolling Interests

( 3 ) 6

Net (Loss) Income Attributable to Merck & Co., Inc.

$ ( 4,240 ) $ 5,079

Basic (Loss) Earnings per Common Share Attributable to Merck & Co., Inc. Common Shareholders

$ ( 1.72 ) $ 2.01

(Loss) Earnings per Common Share Assuming Dilution Attributable to Merck & Co., Inc. Common Shareholders

$ ( 1.72 ) $ 2.01

MERCK & CO., INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENT OF COMPREHENSIVE (LOSS) INCOME

(Unaudited, $ in millions)

Three Months Ended

March 31,

2026 2025

Net (Loss) Income Attributable to Merck & Co., Inc.

$ ( 4,240 ) $ 5,079

Other Comprehensive Income (Loss) Net of Taxes:

Net unrealized gain (loss) on derivatives, net of reclassifications

216   ( 217 )

Benefit plan net gain (loss) and prior service credit (cost), net of amortization

5   ( 18 )

Cumulative translation adjustment 6   215

227   ( 20 )

Comprehensive (Loss) Income Attributable to Merck & Co., Inc.

$ ( 4,013 ) $ 5,059

The accompanying notes are an integral part of these condensed consolidated financial statements.

  • 3 -

MERCK & CO., INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED BALANCE SHEET

(Unaudited, $ in millions except per share amounts)

March 31, 2026 December 31, 2025

Assets

Current Assets

Cash and cash equivalents $ 5,327   $ 14,565

Short-term investments 375   —

Accounts receivable (net of allowance for doubtful accounts of $ 103 in 2026

and $ 97 in 2025)

12,210   11,775

Inventories (excludes inventories of $ 6,195 in 2026 and $ 5,681 in 2025

classified in Other assets - see Note 6)

6,479   6,658

Other current assets 10,624   10,518

Total current assets 35,015   43,516

Investments 1,105   956

Property, Plant and Equipment, at cost, net of accumulated depreciation of $ 22,288

in 2026 and $ 21,914 in 2025

25,433   25,316

Goodwill 21,581   21,579

Other Intangibles, Net 25,745   26,681

Other Assets 19,806   18,818

$ 128,685   $ 136,866

Liabilities and Equity

Current Liabilities

Loans payable and current portion of long-term debt $ 2,444   $ 2,589

Trade accounts payable 3,863   4,404

Accrued and other current liabilities 14,549   14,468

Income taxes payable 3,946   4,726

Dividends payable 2,143   2,140

Total current liabilities 26,945   28,327

Long-Term Debt 46,673   46,750

Deferred Income Taxes 1,494   1,439

Other Noncurrent Liabilities 7,642   7,688

Merck & Co., Inc. Stockholders’ Equity

Common stock, $ 0.50 par value

Authorized - 6,500,000,000 shares

Issued - 3,577,103,522 shares in 2026 and 2025

1,788   1,788

Other paid-in capital 45,176   45,029

Retained earnings 66,721   73,075

Accumulated other comprehensive loss ( 4,060 ) ( 4,287 )

109,625   115,605

Less treasury stock, at cost:

1,107,410,143 shares in 2026 and 1,102,476,756 shares in 2025

63,747   62,999

Total Merck & Co., Inc. stockholders’ equity 45,878   52,606

Noncontrolling Interests 53   56

Total equity 45,931   52,662

$ 128,685   $ 136,866

The accompanying notes are an integral part of this condensed consolidated financial statement.

  • 4 -

MERCK & CO., INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENT OF CASH FLOWS

(Unaudited, $ in millions)

Three Months Ended

March 31,

2026 2025

Cash Flows from Operating Activities

Net (loss) income

$ ( 4,243 ) $ 5,085

Adjustments to reconcile net (loss) income to net cash provided by operating activities:

Amortization 931   597

Depreciation 581   502

Income from investments in equity securities, net ( 168 ) ( 90 )

Charge for research and development asset acquisition

8,540   —

Deferred income taxes ( 315 ) ( 186 )

Share-based compensation 185   195

Other 20   109

Net changes in assets and liabilities ( 1,613 ) ( 3,712 )

Net Cash Provided by Operating Activities 3,918   2,500

Cash Flows from Investing Activities

Capital expenditures ( 991 ) ( 1,328 )

Purchases of securities and other investments ( 374 ) ( 595 )

Proceeds from sales of securities and other investments —   456

Acquisition of Cidara Therapeutics, Inc., net of cash acquired

( 8,779 ) —

Other ( 66 ) ( 20 )

Net Cash Used in Investing Activities ( 10,210 ) ( 1,487 )

Cash Flows from Financing Activities

Net change in short-term borrowings

1,061   —

Payments on debt ( 1,140 ) ( 2,500 )

Dividends paid to stockholders ( 2,105 ) ( 2,050 )

Purchases of treasury stock ( 874 ) ( 1,164 )

Proceeds from exercise of stock options 157   19

Other ( 80 ) ( 60 )

Net Cash Used in Financing Activities

( 2,981 ) ( 5,755 )

Effect of Exchange Rate Changes on Cash, Cash Equivalents and Restricted Cash ( 19 ) 156

Net Decrease in Cash, Cash Equivalents and Restricted Cash

( 9,292 ) ( 4,586 )

Cash, Cash Equivalents and Restricted Cash at Beginning of Year (includes restricted cash of

$ 125 and $ 76 at January 1, 2026 and 2025, respectively, included in Other current assets )

14,690   13,318

Cash, Cash Equivalents and Restricted Cash at End of Period (includes restricted cash of $ 71

and $ 103 at March 31, 2026 and 2025, respectively, included in Other current assets )

$ 5,398   $ 8,732

The accompanying notes are an integral part of this condensed consolidated financial statement.

  • 5 -

Notes to Condensed Consolidated Financial Statements (unaudited)

1. Basis of Presentation

The accompanying unaudited condensed consolidated financial statements of Merck & Co., Inc. (Merck or the Company) have been prepared pursuant to the rules and regulations for reporting on Form 10-Q. Accordingly, certain information and disclosures required by accounting principles generally accepted in the United States (U.S.) for complete consolidated financial statements are not included herein. These interim statements should be read in conjunction with the audited financial statements and notes thereto included in Merck’s Form 10-K filed on February 24, 2026.

The results of operations of any interim period are not necessarily indicative of the results of operations for the full year. In the Company’s opinion, all adjustments necessary for a fair statement of these interim statements have been included and are of a normal and recurring nature. Certain reclassifications have been made to prior year amounts to conform to the current year presentation.

Recently Issued Accounting Standards Not Yet Adopted

In November 2024, the Financial Accounting Standards Board (FASB) issued guidance intended to improve financial reporting by requiring entities to disclose additional information about specific expense categories for interim and annual reporting periods. The guidance is effective for 2027 annual reporting and 2028 interim reporting. Early adoption is permitted. The guidance, which can be applied on a prospective or retrospective basis, will result in incremental disclosures within the footnotes to the Company’s financial statements.

In December 2025, the FASB issued guidance that includes requirements for recognition of government grants in a company’s financial statements as well as disclosure requirements, including the nature of the government grant received, the accounting policies used to account for the grant, and significant terms and conditions of the grant. The guidance is effective for 2029 interim and annual reporting on a modified prospective, modified retrospective or retrospective approach. Early adoption is permitted as of the beginning of an annual reporting period. The Company is currently evaluating the impact of adoption on its consolidated financial statements.

2.     Acquisitions, Research Collaborations and Licensing Agreements

The Company continues to pursue acquisitions and the establishment of external alliances such as research collaborations and licensing agreements to complement its internal research capabilities. These arrangements often include upfront payments; expense reimbursements or payments to the third party; milestone, royalty or profit share arrangements contingent upon the occurrence of certain future events linked to the success of the asset in development; and can also include option and continuation payments. The Company also reviews its marketed products and pipeline to examine candidates which may provide more value through out-licensing and, as part of its portfolio assessment process, may also divest certain assets. Pro forma financial information for acquired businesses is not presented if the historical financial results of the acquired entity are not significant when compared with the Company’s financial results.

2026 Transactions

In March 2026, Merck entered into a definitive agreement to acquire Terns Pharmaceuticals, Inc. (Terns), a clinical-stage oncology company, for $ 53 per share, for a total transaction value of approximately $ 6.7 billion. Through this acquisition, Merck will acquire Terns’ lead candidate, TERN-701, a novel investigational oral allosteric BCR::ABL1 tyrosine kinase inhibitor (TKI) currently being evaluated in a Phase 1/2 trial for patients with Philadelphia chromosome-positive, chronic phase chronic myeloid leukemia previously treated with at least one prior TKI and who experienced treatment failure, suboptimal response or treatment intolerance. The transaction has been approved by both Merck’s and Terns’ Boards of Directors. The acquisition is subject to a majority of Terns’ stockholders tendering their shares in the tender offer initiated by Merck in April 2026. The consummation of the proposed transaction is also subject to customary closing conditions. Merck anticipates the transaction will be accounted for as an asset acquisition since TERN-701 is expected to account for substantially all of the fair value of the gross assets to be acquired (excluding cash and deferred income taxes). Upon closing of the transaction, which is anticipated in May 2026, Merck expects to record a charge of approximately $ 5.8  billion to Research and development expenses. There are no future contingent payments associated with the acquisition.

In January 2026, Merck acquired Cidara Therapeutics, Inc. (Cidara), a biotechnology company developing drug-Fc conjugate (DFC) therapeutics, for $ 9.2  billion (including $ 570 million of payments to settle share-based equity awards of which $ 406  million related to unvested equity awards). Cidara’s lead DFC candidate, MK-1406 (formerly CD388), is a long-acting antiviral designed to prevent seasonal and pandemic influenza. MK-1406 is currently being evaluated in a Phase 3 trial among adult and adolescent participants who are at higher risk of developing complications from influenza. The transaction was accounted for as an asset acquisition since MK-1406 accounted for substantially all of the fair value of the gross assets acquired (excluding cash and deferred income taxes). Merck recorded a charge of $ 9.0  billion to Research and development expenses (which primarily represented acquired in-process research and development with no alternative future use), as well as net assets of $ 332 million in the first quarter of 2026. Under a previous license agreement between Cidara and J&J Innovative Medicine (a Johnson & Johnson company, previously Janssen Pharmaceuticals, Inc.), which was assumed by Merck, J&J Innovative Medicine is eligible to receive up to $ 105  million in regulatory milestones and up to $ 455  million in sales-based milestones related to MK-1406.

  • 6 -

Notes to Condensed Consolidated Financial Statements (unaudited) (continued)

2025 Transactions

In October 2025, Merck and Blackstone Life Sciences (Blackstone) entered into a funding arrangement under which Blackstone will pay Merck $ 700  million in the fourth quarter of 2026 (which is non-refundable, subject to the termination provisions of the agreement) to fund a portion of the Company’s development costs for MK-2870, sacituzumab tirumotecan (sac-TMT), expected to be incurred throughout 2026. Under the terms of the agreement, Merck recognized $ 200  million of funding in the first quarter of 2026 as a reduction to Research and development expenses, and also recognized a corresponding receivable from Blackstone, which was recorded in Other current assets. Upon receipt of regulatory approval for an indication in the U.S. for first-line triple-negative-breast cancer (TroFuse-011 trial), Blackstone will be eligible to receive low-to-mid single-digit royalties on net sales of sac-TMT subsequent to such approval across all approved indications in Merck’s marketing territories. Sac-TMT is an investigational trophoblast cell-surface antigen 2 (TROP2)-directed antibody drug conjugate (ADC) being developed as part of an exclusive license and collaboration agreement with Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (Kelun-Biotech) that is currently in clinical development for the treatment of a variety of cancers. The agreement between Merck and Kelun-Biotech with respect to sac-TMT is unchanged by the agreement with Blackstone. Merck retained decision-making authority and control over the development, manufacturing, and commercial activities relating to sac-TMT provided for in the agreement with Kelun-Biotech, and Blackstone did not receive any rights to sac-TMT.

In March 2025, Merck acquired the Dundalk, Ireland facility of WuXi Vaccines (a wholly owned subsidiary of WuXi Biologics), which was accounted for as an asset acquisition. Merck paid $ 437 million at closing which, combined with previous consideration transferred under a prior manufacturing arrangement with WuXi Vaccines related to this facility, resulted in $ 759  million being recorded as assets under construction within Property, Plant and Equipment . There are no future contingent payments associated with the acquisition.

3.     Collaborative Arrangements

Merck has entered into collaborative arrangements that provide the Company with varying rights to develop, produce and market products together with its collaborative partners. Both parties in these arrangements are active participants and exposed to significant risks and rewards dependent on the commercial success of the activities of the collaboration. Merck’s more significant collaborative arrangements are discussed below.

AstraZeneca PLC

In 2017, Merck and AstraZeneca PLC (AstraZeneca) entered into a global strategic oncology collaboration to co-develop and co-commercialize AstraZeneca’s Lynparza (olaparib) for multiple cancer types. Independently, Merck and AstraZeneca are developing and commercializing Lynparza in combinations with their respective PD-1 and PD-L1 medicines, Keytruda (pembrolizumab) and Imfinzi. Under the terms of the agreement, AstraZeneca and Merck share the development and commercialization costs for Lynparza monotherapy and non-PD-1/PD-L1 combination therapy opportunities.

Profits from Lynparza product sales generated through monotherapies or combination therapies are shared equally. AstraZeneca is the principal on Lynparza sales transactions. Merck records its share of Lynparza product sales, net of cost of sales and commercialization costs, as alliance revenue, and its share of development costs associated with the collaboration as part of Research and development expenses. Reimbursements received from AstraZeneca for research and development expenses are recognized as reductions to Research and development costs.

The initial collaboration agreement also included the joint development and commercialization of AstraZeneca’s Koselugo (selumetinib) for multiple indications, with revenues, costs and profits being accounted for similar to Lynparza. In August 2025, Merck and AstraZeneca amended the terms of the original collaboration agreement, which resulted in the discontinuation of the revenue and cost sharing provisions of the collaboration and the simplification of the governance structure related to Koselugo. In exchange, Merck received a $ 150  million upfront payment (which was recorded within Sales as alliance revenue in the third quarter of 2025) and $ 150  million in February 2026 (which was recorded within Sales as alliance revenue in the first quarter of 2026). Merck may also receive $ 150  million in the first quarter of 2027 and $ 100  million in the first quarter of 2028, subject to an annual election by AstraZeneca in January of each year as discussed below. Additionally, the amended agreement provided for Merck to receive contingent regulatory milestone payments of up to $ 175  million in the aggregate, all of which were triggered in 2025 and recorded within Sales as alliance revenue. Of these milestone amounts, $ 50  million is due from AstraZeneca in the third quarter of 2026, $ 50  million is due in the third quarter of 2027, and $ 75  million is due in the third quarter of 2028. The Company is also receiving mid-single-digit royalties on net sales (which are included within Sales as alliance revenue). Merck remains eligible to receive future contingent payments for the achievement of sales-based milestones of up to $ 235  million. AstraZeneca has the option in January 2027 or January 2028 to revert back to the income and cost sharing terms of the original agreement (in which case any future annual, contingent milestone, and royalty payments referenced above would no longer be due) although Merck would retain any payments made by AstraZeneca prior to the exercise of that option and any amounts due from AstraZeneca would remain payable to Merck.

As part of the initial collaboration agreement, Merck made an upfront payment to AstraZeneca and also made payments over a multi-year period for certain license options. In addition, the initial collaboration agreement provided for contingent payments from Merck to AstraZeneca related to the successful achievement of sales-based and regulatory milestones. In the first quarter of 2025, Merck made sales-based milestone payments aggregating $ 700  million (related to the original collaboration agreement) to AstraZeneca of which $ 600  million related to Lynparza and $ 100  million related to Koselugo (both of which had been previously accrued for). Potential future sales-based milestone payments of $ 2.0 billion have not yet

  • 7 -

Notes to Condensed Consolidated Financial Statements (unaudited) (continued)

been accrued as they are not deemed by the Company to be probable at this time. The partners have agreed that no future regulatory milestone payments from Merck to AstraZeneca are likely.

The intangible asset balances related to Lynparza and Koselugo (which reflect the capitalized sales-based and regulatory milestone payments attributed to each product) were $ 762 million and $ 36 million, respectively, at March 31, 2026 and are included in Other Intangibles, Net . The assets are being amortized over their estimated useful lives (through 2028 for Lynparza and through 2029 for Koselugo) as supported by projected future cash flows, subject to impairment testing.

Summarized financial information related to this collaboration is as follows:

Three Months Ended

March 31,

($ in millions) 2026 2025

Alliance revenue - Lynparza $ 341   $ 312

Alliance revenue - Koselugo (1)

161   44

Total alliance revenue $ 502   $ 356

Cost of sales (2)

84   83

Selling, general and administrative 24   32

Research and development 5   12

($ in millions) March 31, 2026 December 31, 2025

Receivables from AstraZeneca included in Other current assets (3)

$ 401   $ 451

Receivables from AstraZeneca included in Other assets (3)

125   125

Payables to AstraZeneca included in Accrued and other current liabilities

12   6

(1)     Amount in the first quarter of 2026 includes $ 150  million related to the amendment of the collaboration agreement noted above.

(2)     Represents amortization of capitalized milestone payments.

(3)     Includes milestone receivables.

Eisai Co., Ltd.

In 2018, Merck and Eisai Co., Ltd. (Eisai) announced a strategic collaboration for the worldwide co-development and co-commercialization of Lenvima (lenvatinib), an orally available TKI discovered by Eisai. Under the agreement, Merck and Eisai are developing and commercializing Lenvima jointly, both as monotherapy and in combination with Keytruda . Eisai records Lenvima product sales globally (Eisai is the principal on Lenvima sales transactions) and Merck and Eisai share applicable profits equally. Merck records its share of Lenvima product sales, net of cost of sales and commercialization costs, as alliance revenue. Expenses incurred during co-development are shared by the two companies in accordance with the collaboration agreement and reflected in Research and development expenses. Certain expenses incurred solely by Merck or Eisai are not shareable under the collaboration agreement, including costs incurred in excess of agreed upon caps, and costs related to certain combination studies of Keytruda and Lenvima, as well as Welireg (belzutifan) and Lenvima.

Under the agreement, Merck made an upfront payment to Eisai and also made payments over a multi-year period for certain option rights. In addition, the agreement provides for contingent payments from Merck to Eisai related to the successful achievement of sales-based and regulatory milestones. Potential future sales-based milestone payments of $ 2.3 billion have not yet been accrued as they are not deemed by the Company to be probable at this time. There are no regulatory milestone payments remaining under the agreement.

The intangible asset balance related to Lenvima (which includes capitalized sales-based and regulatory milestone payments) was $ 188 million at March 31, 2026 and is included in Other Intangibles, Net . The amount is being amortized over its estimated useful life through 2029 as supported by projected future cash flows, subject to impairment testing.

Summarized financial information related to this collaboration is as follows:

Three Months Ended

March 31,

($ in millions) 2026 2025

Alliance revenue - Lenvima $ 256   $ 258

Cost of sales (1)

13   60

Selling, general and administrative 27   31

Research and development 2   5

($ in millions) March 31, 2026 December 31, 2025

Receivables from Eisai included in Other current assets

$ 252   $ 271

(1)     Represents amortization of capitalized milestone payments.

  • 8 -

Notes to Condensed Consolidated Financial Statements (unaudited) (continued)

Bayer AG

In 2014, the Company entered into a worldwide clinical development collaboration with Bayer AG (Bayer) to market and develop soluble guanylate cyclase (sGC) modulators including Bayer’s Adempas (riociguat) and Verquvo (vericiguat). The two companies have implemented a joint development and commercialization strategy. Under the agreement, Bayer commercializes Adempas in the Americas, while Merck commercializes in the rest of the world. For Verquvo, Merck commercializes in the U.S. and Bayer commercializes in the rest of the world. Both companies share in development costs and profits on sales. Merck records sales of Adempas and Verquvo in its marketing territories, as well as alliance revenue. Alliance revenue represents Merck’s share of profits from sales of Adempas and Verquvo in Bayer’s marketing territories, which are product sales net of cost of sales and commercialization costs. Cost of sales includes Bayer’s share of profits from sales in Merck’s marketing territories. The agreement provided for contingent payments from Merck to Bayer related to the successful achievement of sales-based milestones. There are no such payments remaining under this collaboration.

The intangible asset balances related to Adempas (which includes the acquired intangible asset balance, as well as capitalized sales-based milestone payments attributed to Adempas) and Verquvo (which reflects the portion of the final sales-based milestone payment that was attributed to Verquvo) were $ 239 million and $ 37 million, respectively, at March 31, 2026 and are included in Other Intangibles, Net . The assets are being amortized over their estimated useful lives (through 2027 for Adempas and through 2031 for Verquvo) as supported by projected future cash flows, subject to impairment testing.

Summarized financial information related to this collaboration is as follows:

Three Months Ended

March 31,

($ in millions) 2026 2025

Alliance revenue - Adempas/Verquvo $ 109   $ 106

Net sales of Adempas recorded by Merck 78   68

Net sales of Verquvo recorded by Merck 9   9

Total sales $ 196   $ 183

Cost of sales (1)

67   58

Selling, general and administrative 12   29

Research and development 17   24

($ in millions) March 31, 2026 December 31, 2025

Receivables from Bayer included in Other current assets

$ 162   $ 167

Payables to Bayer included in Accrued and other current liabilities

87   81

(1)     Includes amortization of intangible assets, cost of products sold by Merck, as well as Bayer’s share of profits from sales in Merck’s marketing territories.

Ridgeback Biotherapeutics LP

In 2020, Merck and Ridgeback Biotherapeutics LP (Ridgeback), a closely held biotechnology company, entered into a collaboration agreement to develop Lagevrio (molnupiravir), an investigational orally available antiviral candidate for the treatment of patients with COVID-19. Merck gained exclusive worldwide rights to develop and commercialize Lagevrio and related molecules. Following initial authorizations in certain markets in 2021, Lagevrio has since received multiple additional authorizations.

Under the terms of the agreement, Ridgeback received an upfront payment and is eligible to receive future contingent payments dependent upon the achievement of certain developmental and regulatory approval milestones. The agreement also provides for Merck to reimburse Ridgeback for a portion of certain third-party contingent milestone payments and royalties on net sales, which is part of the profit-sharing calculation. Merck is the principal on sales transactions, recognizing sales and related costs, with profit-sharing amounts recorded within Cost of sales . Profits from the collaboration are split equally between the partners. Reimbursements from Ridgeback for its share of research and development costs (deducted from Ridgeback’s share of profits) are reflected as decreases to Research and development expenses.

Summarized financial information related to this collaboration is as follows:

Three Months Ended

March 31,

($ in millions) 2026 2025

Net sales of Lagevrio recorded by Merck

$ 28   $ 102

Cost of sales (1)

54   53

Selling, general and administrative

11   13

Research and development

5   8

(1)     Includes cost of products sold by Merck, Ridgeback’s share of profits, royalty expense, amortization of capitalized milestone payments and inventory reserves.

  • 9 -

Notes to Condensed Consolidated Financial Statements (unaudited) (continued)

Daiichi Sankyo

In 2023, Merck and Daiichi Sankyo entered into a global development and commercialization agreement for three of Daiichi Sankyo’s DXd ADC candidates: patritumab deruxtecan (MK-1022), ifinatamab deruxtecan (MK-2400) and raludotatug deruxtecan (MK-5909). All three potentially first-in-class DXd ADCs are in various stages of clinical development for the treatment of multiple solid tumors both as monotherapy and/or in combination with other treatments. The companies will jointly develop and potentially commercialize these ADC candidates worldwide, except in Japan where Daiichi Sankyo will maintain exclusive rights. Daiichi Sankyo will be solely responsible for manufacturing and supply.

Under the terms of the agreement, Merck made payments to Daiichi Sankyo totaling $ 4.0  billion in 2023. These payments included $ 1.0  billion ($ 500  million each for patritumab deruxtecan and ifinatamab deruxtecan), which may be refundable on a pro-rated basis in the event of early termination of development with respect to either program. In addition, the agreement provided for a continuation payment of $ 750  million related to patritumab deruxtecan (which Merck paid in October 2024) and a continuation payment of $ 750  million related to raludotatug deruxtecan (which Merck paid in October 2025). The agreement also provides for contingent payments from Merck to Daiichi Sankyo of up to an additional $ 5.5  billion for each DXd ADC upon the successful achievement of certain sales-based milestones.

Merck and Daiichi Sankyo equally share research and development costs, except for raludotatug deruxtecan, where Merck is responsible for 75 % of the first $ 2.0  billion of research and development expenses. Merck includes its share of development costs associated with the collaboration as part of Research and development expenses. Following regulatory approval, Daiichi Sankyo will generally record sales worldwide (Daiichi Sankyo will be the principal on sales transactions) and the companies will equally share expenses as well as profits worldwide except for Japan where Daiichi Sankyo retains exclusive rights and Merck will receive a 5 % sales-based royalty. Merck will record its share of product sales, net of cost of sales and commercialization costs, as alliance revenue.

In 2024, Merck and Daiichi Sankyo expanded their agreement to include gocatamig (MK-6070), an investigational DLL3 targeting T-cell engager, which Merck obtained through its acquisition of Harpoon Therapeutics, Inc. The companies are planning to evaluate gocatamig in combination with ifinatamab deruxtecan in certain patients with small cell lung cancer, as well as other potential combinations. Merck received an upfront cash payment of $ 170  million from Daiichi Sankyo (recorded within Other (income) expense, net) and has also satisfied a contingent quid obligation from the original collaboration agreement. The companies will jointly develop and commercialize gocatamig worldwide and share research and development costs, as well as commercialization expenses. Research and development expenses related to gocatamig in combination with ifinatamab deruxtecan will be shared in a manner consistent with the original agreement for ifinatamab deruxtecan. Merck will be solely responsible for manufacturing and supply of gocatamig. If approved, Merck will generally record sales for gocatamig worldwide (Merck will be the principal on sales transactions) and the companies will equally share expenses as well as profits worldwide, except for Japan where Merck retains exclusive rights and Daiichi Sankyo will receive a 5 % sales-based royalty.

Summarized financial information related to this collaboration is as follows:

Three Months Ended

March 31,

($ in millions) 2026 2025

Selling, general and administrative $ 12   $ 9

Research and development

160   128

($ in millions) March 31, 2026 December 31, 2025

Receivables from Daiichi Sankyo included in Other current assets

$ 22   $ 15

Payables to Daiichi Sankyo included in Accrued and other current liabilities

85   113

Moderna, Inc.

In 2022, Merck exercised its option to jointly develop and commercialize intismeran autogene (V940/mRNA-4157), an investigational individualized neoantigen therapy, pursuant to the terms of an existing collaboration and license agreement with Moderna, Inc. (Moderna). Intismeran autogene is currently being evaluated in combination with Keytruda in multiple clinical trials. Merck and Moderna share costs and will share any profits equally under this worldwide collaboration. Merck records its share of development costs associated with the collaboration as part of Research and development expenses. Any reimbursements received from Moderna for research and development expenses are recognized as reductions to Research and development costs. Merck has also capitalized a net $ 230  million of shared facility costs at March 31, 2026, primarily reflected within Other Assets . These costs are amortized over the assets’ estimated useful lives.

  • 10 -

Notes to Condensed Consolidated Financial Statements (unaudited) (continued)

Summarized financial information related to this collaboration is as follows:

Three Months Ended

March 31,

($ in millions) 2026 2025

Selling, general and administrative $ 8   $ 6

Research and development (1)

90   86

($ in millions) March 31, 2026 December 31, 2025

Receivables from Moderna included in Other current assets

$ 4   $ —

Payables to Moderna included in Accrued and other current liabilities

—   13

(1)     Includes amortization of shared facility costs.

Bristol-Myers Squibb Company

Reblozyl (luspatercept-aamt) is a first-in-class erythroid maturation recombinant fusion protein that is being commercialized through a global collaboration with Bristol-Myers Squibb Company (BMS). Reblozyl is approved in the U.S., Europe and certain other markets for the treatment of anemia in certain rare blood disorders and is also being evaluated for additional indications for hematology therapies. BMS is the principal on sales transactions for Reblozyl. Merck receives tiered royalties ranging from 20 % to 24 % based on sales levels. This royalty will be reduced by 50 % upon the earlier of patent expiry or generic entry on an indication-by-indication basis in each market. Additionally, Merck is eligible to receive future contingent sales-based milestone payments of up to $ 80  million. Alliance revenue related to this collaboration, consisting of royalties (recorded within Sales ), was $ 148 million and $ 119 million in the first quarter of 2026 and 2025, respectively.

4.     Restructuring

In July 2025, the Company approved a restructuring program (2025 Restructuring Program) designed to position the Company for its next chapter of growth and to successfully advance its pipeline and launch new products across multiple therapeutic areas. As part of this program, the Company expects to eliminate certain positions in sales and administrative organizations, as well as research and development. The Company will, however, continue to hire employees into new roles across all strategic growth areas of the business. In addition, the Company will reduce its global real estate footprint and continue to optimize its manufacturing network, aligning the geography of its global manufacturing footprint to its customers and reflecting changes in the Company’s business. Most actions contemplated under the 2025 Restructuring Program are expected to be largely completed by the end of 2027, with the exception of certain manufacturing actions, which are expected to be substantially completed by the end of 2029. The cumulative pretax costs to be incurred by the Company to implement the program are estimated to be approximately $ 3.0 billion, of which approximately 60 % will be cash, relating primarily to employee separation expense and contractual termination costs. The remainder of the costs will be non-cash, relating primarily to the accelerated depreciation of facilities. The Company recorded total pretax costs of $ 318 million in the first quarter of 2026 related to the 2025 Restructuring Program. Since inception of the 2025 Restructuring Program through March 31, 2026, Merck has incurred total cumulative pretax costs of $ 2.3 billion.

In January 2024, the Company approved a restructuring program (2024 Restructuring Program) intended to continue the optimization of the Company’s Human Health global manufacturing network as the future pipeline shifts to new modalities and also optimize the Animal Health global manufacturing network to improve supply reliability and increase efficiency. The actions contemplated under the 2024 Restructuring Program are expected to be substantially completed by the end of 2031, with the cumulative pretax costs to be incurred by the Company to implement the program estimated to be approximately $ 4.0 billion. Approximately 50 % of the cumulative pretax costs will be non-cash, relating primarily to the accelerated depreciation of facilities to be closed or divested. The remainder of the costs will result in cash outlays, relating primarily to facility shut-down costs. The Company recorded total pretax costs of $ 148 million and $ 105 million in the first quarter of 2026 and 2025, respectively, related to the 2024 Restructuring Program. Since inception of the 2024 Restructuring Program through March 31, 2026, Merck has incurred total cumulative pretax costs of $ 1.8 billion.

For segment reporting, restructuring charges are unallocated expenses.

  • 11 -

Notes to Condensed Consolidated Financial Statements (unaudited) (continued)

The following tables summarize the charges related to restructuring program activities by type of cost:

Three Months Ended March 31, 2026

($ in millions) Accelerated Depreciation

Separation Costs

Other Exit Costs

Total

2025 Restructuring Program

Cost of sales $ 12   $ —   $ 132   $ 144

Research and development —   —   34   34

Restructuring costs —   123   17   140

12   123   183   318

2024 Restructuring Program

Cost of sales 96   —   ( 3 ) 93

Restructuring costs —   —   55   55

96   —   52   148

$ 108   $ 123   $ 235   $ 466

Three Months Ended March 31, 2025

($ in millions) Accelerated Depreciation

Separation Costs

Other Exit Costs

Total

2024 Restructuring Program

Cost of sales $ 41   $ —   $ ( 5 ) $ 36

Restructuring costs —   1   68   69

$ 41   $ 1   $ 63   $ 105

Accelerated depreciation costs primarily relate to manufacturing, research and administrative facilities to be fully or partially closed or divested and equipment to be disposed of as part of the programs. Accelerated depreciation costs represent the difference between the depreciation expense to be recognized over the revised useful life of the asset, based upon the anticipated date the site will be closed or divested or the equipment disposed of, and depreciation expense as determined utilizing the useful life prior to the restructuring actions. All the sites will continue to operate up through the respective closure dates and, since future undiscounted cash flows are sufficient to recover the respective book values, Merck is recording accelerated depreciation over the revised useful life of the site assets. Anticipated site closure dates, particularly related to manufacturing locations, have been and may continue to be adjusted to reflect changes resulting from regulatory or other factors.

Separation costs are associated with actual headcount reductions, as well as involuntary headcount reductions which were probable and could be reasonably estimated.

Other exit costs in 2026 and 2025 include asset impairment, facility shut-down, contractual termination, and other related costs, as well as pretax gains and losses resulting from the sales of facilities and related assets. Additionally, other activity includes certain employee-related costs associated with pension and other postretirement benefit plans (see Note 10) and share-based compensation.

The following table summarizes the charges and spending related to restructuring program activities for the three months ended March 31, 2026:

($ in millions) Accelerated Depreciation

Separation

Costs

Other Exit Costs

Total

2025 Restructuring Program

Restructuring reserves January 1, 2026

$ —   $ 502   $ 288   $ 790

Expenses

12   123   183   318

(Payments) receipts, net —   ( 156 ) ( 166 ) ( 322 )

Non-cash activity ( 12 ) ( 9 ) ( 117 ) ( 138 )

Restructuring reserves March 31, 2026

$ —   $ 460   $ 188   $ 648

2024 Restructuring Program

Restructuring reserves January 1, 2026

$ —   $ 506   $ —   $ 506

Expenses 96   —   52   148

(Payments) receipts, net —   ( 70 ) ( 53 ) ( 123 )

Non-cash activity ( 96 ) 12   1   ( 83 )

Restructuring reserves March 31, 2026

$ —   $ 448   $ —   $ 448

  • 12 -

Notes to Condensed Consolidated Financial Statements (unaudited) (continued)

5.     Financial Instruments

Derivative Instruments and Hedging Activities

The Company manages the impact of foreign exchange rate movements and interest rate movements on its earnings, cash flows and fair values of assets and liabilities through operational means and through the use of various financial instruments, including derivative instruments.

A significant portion of the Company’s revenues and earnings in foreign affiliates is exposed to changes in foreign exchange rates. The objectives of and accounting related to the Company’s foreign currency risk management program, as well as its interest rate risk management activities are discussed below.

Foreign Currency Risk Management

The Company has established revenue hedging, balance sheet risk management and net investment hedging programs to protect against volatility of future foreign currency cash flows and changes in fair value caused by changes in foreign exchange rates.

The objective of the revenue hedging program is to reduce the variability caused by changes in foreign exchange rates that would affect the U.S. dollar value of future cash flows derived from foreign currency denominated sales, primarily the euro, Japanese yen and Chinese renminbi. To achieve this objective, the Company will hedge a portion of its forecasted foreign currency denominated third-party and intercompany distributor entity sales (forecasted sales) that are expected to occur over its planning cycle, typically no more than two years into the future. The Company will layer in hedges over time, increasing the portion of forecasted sales hedged as it gets closer to the expected date of the forecasted sales. The portion of forecasted sales hedged is based on assessments of cost-benefit profiles that consider natural offsetting exposures, revenue and foreign exchange rate volatilities and correlations, and the cost of hedging instruments. The Company manages its anticipated transaction exposure principally with purchased local currency put options, forward contracts, and purchased collar options.

The fair values of these derivative contracts are recorded as either assets (gain positions) or liabilities (loss positions) in the Condensed Consolidated Balance Sheet. Changes in the fair value of derivative contracts are recorded each period in either current earnings or Other comprehensive income ( OCI ), depending on whether the derivative is designated as part of a hedge transaction and, if so, the type of hedge transaction. For derivatives that are designated as cash flow hedges, the unrealized gains or losses on these contracts are recorded in Accumulated Other Comprehensive Loss ( AOCL) and reclassified into Sales when the hedged anticipated revenue is recognized. The amount reclassified into earnings as a result of the discontinuation of cash flow hedges because it was no longer deemed probable the forecasted hedged transactions would occur was not material for the first quarter of either 2026 or 2025. For those derivatives which are not designated as cash flow hedges, but serve as economic hedges of forecasted sales, unrealized gains or losses are recorded in Sales each period. The cash flows from both designated and non-designated contracts are reported as operating activities in the Condensed Consolidated Statement of Cash Flows. The Company does not enter into derivatives for trading or speculative purposes.

The Company manages operating activities and net asset positions at each local subsidiary in order to mitigate the effects of foreign exchange on monetary assets and liabilities. Monetary assets and liabilities denominated in a currency other than the functional currency of a given subsidiary are remeasured at spot rates in effect on the balance sheet date with the effects of changes in spot rates reported in Other (income) expense, net . The Company also uses a balance sheet risk management program to mitigate the exposure of such assets and liabilities from the effects of volatility in foreign exchange. Merck principally utilizes forward exchange contracts to offset the effects of foreign exchange on exposures when it is deemed economical to do so based on a cost-benefit analysis that considers the magnitude of the exposure, the volatility of the foreign exchange rate and the cost of the hedging instrument (primarily the euro, Swiss franc, Japanese yen, and Chinese renminbi). The forward contracts are not designated as hedges and are marked to market through Other (income) expense, net . Accordingly, fair value changes in the forward contracts help mitigate the changes in the value of the remeasured assets and liabilities attributable to changes in foreign currency exchange rates, except to the extent of the spot-forward differences. These differences are not significant due to the short-term nature of the contracts, which typically have average maturities at inception of less than six months . The cash flows from these contracts are reported as operating activities in the Condensed Consolidated Statement of Cash Flows.

The Company also uses forward exchange contracts to hedge a portion of its net investment in foreign operations against movements in foreign exchange rates. The forward contracts are designated as hedges of the net investment in a foreign operation. The unrealized gains or losses on these contracts are recorded in foreign currency translation adjustment within OCI and remain in AOCL until either the sale or complete or substantially complete liquidation of the subsidiary. The Company excludes certain portions of the change in fair value of its derivative instruments from the assessment of hedge effectiveness (excluded components). Changes in fair value of the excluded components are recognized in OCI . The Company recognizes in earnings the initial value of the excluded components on a straight-line basis over the life of the derivative instrument, rather than using the mark-to-market approach. The cash flows from these contracts are reported as investing activities in the Condensed Consolidated Statement of Cash Flows.

Foreign exchange risk is also managed through the use of foreign currency debt. Certain of the Company’s senior unsecured euro-denominated notes have been designated as, and are effective as, economic hedges of the net investment in a foreign operation. Accordingly, foreign currency transaction gains or losses due to spot rate fluctuations on the euro-denominated debt instruments are included in foreign currency translation adjustment within OCI .

  • 13 -

Notes to Condensed Consolidated Financial Statements (unaudited) (continued)

The effects of the Company’s net investment hedges on OCI and the Condensed Consolidated Statement of Income are shown below:

Amount of Pretax (Gain) Loss Recognized in Other Comprehensive Income (1)

Amount of Pretax Gain Recognized in Other (income) expense, net for Amounts Excluded from Effectiveness Testing

Three Months Ended March 31, Three Months Ended March 31,

($ in millions) 2026 2025 2026 2025

Net Investment Hedging Relationships

Foreign exchange contracts $ ( 15 ) $ 27   $ ( 4 ) $ ( 3 )

Euro-denominated notes ( 137 ) 130   —   —

(1)     No amounts were reclassified from AOCL into income related to the sale of a subsidiary.

Interest Rate Risk Management

The Company may use interest rate swap contracts on certain investing and borrowing transactions to manage its net exposure to interest rate changes and to reduce its overall cost of borrowing. The Company does not use leveraged swaps and, in general, does not leverage any of its investment activities that would put principal at risk.

At March 31, 2026, the Company was a party to ten pay-floating, receive-fixed interest rate swap contracts designated as fair value hedges of a portion of fixed-rate notes as detailed in the table below.

March 31, 2026

($ in millions)

Par Value of Debt

Number of Interest Rate Swaps Held

Total Swap Notional Amount

4.50 % notes due 2033

$ 1,500   6   $ 1,500

4.75 % notes due 2035

1,500   2   500

5.00 % notes due 2053

1,500   2   500

The interest rate swap contracts are designated hedges of the fair value changes in the notes attributable to changes in the benchmark Secured Overnight Financing Rate (SOFR) swap rate. The fair value changes in the notes attributable to changes in the SOFR swap rate are recorded in interest expense along with the offsetting fair value changes in the swap contracts. The cash flows from these contracts are reported as operating activities in the Condensed Consolidated Statement of Cash Flows. In February 2026, the Company entered into two forward starting swaps, each with a notional amount of $ 250  million.

The table below presents the location of amounts recorded in the Condensed Consolidated Balance Sheet related to cumulative basis adjustments for fair value hedges:

Carrying Amount of Hedged Liabilities

Cumulative Amount of Fair Value Hedging Adjustment Increase Included in the Carrying Amount

($ in millions)

March 31, 2026 December 31, 2025 March 31, 2026 December 31, 2025

Balance Sheet Caption

Long-Term Debt

$ 2,539   $ 1,810   $ 57   $ 70

  • 14 -

Notes to Condensed Consolidated Financial Statements (unaudited) (continued)

Presented in the table below is the fair value of derivatives on a gross basis segregated between those derivatives that are designated as hedging instruments and those that are not designated as hedging instruments:

March 31, 2026 December 31, 2025

Fair Value of Derivative U.S. Dollar

Notional Fair Value of Derivative U.S. Dollar

Notional

($ in millions) Asset Liability Asset Liability

Derivatives Designated as Hedging Instruments Balance Sheet Caption

Interest rate swap contracts

Other Assets

$ 58   $ —  $ 2,500   $ 71   $ —  $ 1,750

Interest rate contracts

Other Assets

8   —  500   —   —  —

Foreign exchange contracts Other current assets 247   —  7,751   113   —  6,430

Foreign exchange contracts Other Assets 55   —  1,828   32   —  1,793

Foreign exchange contracts Accrued and other current liabilities —  48   3,705   —  131   4,726

Foreign exchange contracts Other Noncurrent Liabilities —  1   33   —  1   13

$ 368   $ 49   $ 16,317   $ 216   $ 132   $ 14,712

Derivatives Not Designated as Hedging Instruments Balance Sheet Caption

Foreign exchange contracts Other current assets $ 194   $ —  $ 13,870   $ 107   $ —  $ 11,643

Foreign exchange contracts Accrued and other current liabilities —  180   11,919   —  191   13,579

Foreign exchange contracts

Other Noncurrent Liabilities

—  —   —   —  1   357

$ 194   $ 180   $ 25,789   $ 107   $ 192   $ 25,579

$ 562   $ 229   $ 42,106   $ 323   $ 324   $ 40,291

As noted above, the Company records its derivatives on a gross basis in the Condensed Consolidated Balance Sheet. The Company has master netting agreements with several of its financial institution counterparties (see Concentrations of Credit Risk below). The following table provides information on the Company’s derivative positions subject to these master netting arrangements as if they were presented on a net basis, allowing for the right of offset by counterparty and cash collateral exchanged per the master agreements and related credit support annexes:

March 31, 2026 December 31, 2025

($ in millions) Asset Liability Asset Liability

Gross amounts recognized in the condensed consolidated balance sheet $ 562   $ 229   $ 323   $ 324

Gross amounts subject to offset in master netting arrangements not offset in the condensed consolidated balance sheet ( 225 ) ( 225 ) ( 245 ) ( 245 )

Cash collateral received

( 89 ) —   ( 1 ) —

Net amounts $ 248   $ 4   $ 77   $ 79

The table below provides information regarding the location and amount of pretax gains and losses of derivatives designated in fair value or cash flow hedging relationships:

Three Months Ended March 31,

($ in millions) 2026 2025 2026 2025 2026 2025

Financial Statement Caption in which Effects of Fair Value or Cash Flow

Hedges are Recorded Sales Other (income) expense, net (1)

Other comprehensive income (loss)

$ 16,286   $ 15,529   $ 138   $ ( 35 ) $ 227   $ ( 20 )

(Gain) loss on fair value hedging relationships:

Interest rate swap contracts

Hedged items —  —  ( 14 ) 38   —  —

Derivatives designated as hedging instruments —  —  13   ( 39 ) —  —

Impact of cash flow hedging relationships:

Foreign exchange contracts

Amount of gain (loss) recognized in OCI on derivatives

—  —  —  —  168   ( 201 )

(Decrease) increase in Sales as a result of AOCL reclassifications

( 98 ) 74   —  —  98   ( 74 )

Interest rate contracts

Amount of gain recognized in Other (income) expense, net on derivatives

—  —  ( 1 ) —   —  —

Amount of gain recognized in OCI on derivatives

—  —  —  —  7   —

(1)     Interest expense is a component of Other (income) expense, net.

  • 15 -

Notes to Condensed Consolidated Financial Statements (unaudited) (continued)

The table below provides information regarding the income statement effects of derivatives not designated as hedging instruments:

Amount of Derivative Pretax Loss (Gain) Recognized in Income

Three Months Ended March 31,

($ in millions) 2026 2025

Derivatives Not Designated as Hedging Instruments Income Statement Caption

Foreign exchange contracts (1)

Other (income) expense, net $ 36   $ ( 20 )

Foreign exchange contracts (2)

Sales 12   16

(1)     These derivative contracts primarily mitigate changes in the value of remeasured foreign currency denominated monetary assets and liabilities attributable to changes in foreign currency exchange rates.

(2)     These derivative contracts serve as economic hedges of forecasted transactions .

At March 31, 2026, the Company estimates $ 69 million of pretax net unrealized gains on derivatives maturing within the next 12 months that hedge foreign currency denominated sales over that same period will be reclassified from AOCL to Sales . The amount ultimately reclassified to Sales may differ as foreign exchange rates change. Realized gains and losses are ultimately determined by actual foreign exchange rates at maturity.

Investments in Debt and Equity Securities

Information on investments in debt and equity securities is as follows:

March 31, 2026 December 31, 2025

Amortized

Cost Gross Unrealized Fair

Value Amortized

Cost Gross Unrealized Fair

Value

($ in millions) Gains Losses Gains Losses

Commercial paper $ 375   $ —   $ —   $ 375   $ —   $ —   $ —   $ —

U.S. government and agency securities 100   —   —   100   100   —   —   100

Foreign government bonds

1   —   —   1   1   —   —   1

Total debt securities $ 476   $ —   $ —   $ 476   $ 101   $ —   $ —   $ 101

Publicly traded equity securities (1)

1,571   1,392

Total debt and publicly traded equity securities $ 2,047   $ 1,493

(1)     Unrealized net gains of $ 126  million were recorded in Other (income) expense, net in the first quarter of 2026 on equity securities still held at March 31, 2026. Unrealized net gains of $ 115 million were recorded in Other (income) expense, net in the first quarter of 2025 on equity securities still held at March 31, 2025.

At March 31, 2026 and March 31, 2025, the Company also had $ 881  million and $ 872  million, respectively, of equity investments without readily determinable fair values included in Other Assets . The Company records unrealized gains on these equity investments based on favorable observable price changes from transactions involving similar investments of the same investee and records unrealized losses based on unfavorable observable price changes, which are included in Other (income) expense, net . During the first quarter of 2026 , the Company recorded unrealized gains of $ 35 million related to certain of these equity investments still held at March 31, 2026. During the first quarter of 2025 , the Company recorded unrealized losses of $ 11  million related to certain of these equity investments still held at March 31, 2025. Cumulative unrealized gains and cumulative unrealized losses based on observable price changes for investments in equity investments without readily determinable fair values still held at March 31, 2026 were $ 320  million and $ 164  million, respectively.

At March 31, 2026 and March 31, 2025, the Company also had $ 229  million and $ 249  million, respectively, recorded in Other Assets for equity securities held through ownership interests in investment funds. (Gains) losses recorded in Other (income) expense, net relating to these investment funds were $( 3 ) million and $ 23  million for the first quarter of 2026 and 2025, respectively.

Fair Value Measurements

Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. The Company uses a fair value hierarchy which maximizes the use of observable inputs and minimizes the use of unobservable inputs when measuring fair value. There are three levels of inputs used to measure fair value with Level 1 having the highest priority and Level 3 having the lowest:

Level 1 - Quoted prices (unadjusted) in active markets for identical assets or liabilities.

Level 2 - Observable inputs other than Level 1 prices, such as quoted prices for similar assets or liabilities, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities.

Level 3 - Unobservable inputs that are supported by little or no market activity. Level 3 assets or liabilities are those whose values are determined using pricing models, discounted cash flow methodologies, or similar techniques with significant unobservable inputs, as well as assets or liabilities for which the determination of fair value requires significant judgment or estimation.

  • 16 -

Notes to Condensed Consolidated Financial Statements (unaudited) (continued)

If the inputs used to measure the financial assets and liabilities fall within more than one level described above, the categorization is based on the lowest level input that is significant to the fair value measurement of the instrument.

Financial Assets and Liabilities Measured at Fair Value on a Recurring Basis

Financial assets and liabilities measured at fair value on a recurring basis are summarized below:

Fair Value Measurements Using Fair Value Measurements Using

Level 1 Level 2 Level 3 Total Level 1 Level 2 Level 3 Total

($ in millions) March 31, 2026 December 31, 2025

Assets

Investments

Commercial paper $ —   $ 375   $ —   $ 375   $ —   $ —   $ —   $ —

Foreign government bonds

—   1   —   1   —   1   —   1

Publicly traded equity securities 1,104   —   —   1,104   955   —   —   955

1,104   376   —   1,480   955   1   —   956

Other assets (1)

U.S. government and agency securities 100   —   —   100   100   —   —   100

Publicly traded equity securities (2)

467   —   —   467   437   —   —   437

567   —   —   567   537   —   —   537

Derivative assets (3)

Forward exchange contracts —   310   —   310   —   168   —   168

Purchased currency options —   186   —   186   —   84   —   84

Interest rate swaps

—   58   —   58   —   71   —   71

Interest rate contracts

—   8   —   8   —   —   —   —

—   562   —   562   —   323   —   323

Total assets $ 1,671   $ 938   $ —   $ 2,609   $ 1,492   $ 324   $ —   $ 1,816

Liabilities

Derivative liabilities (3)

Forward exchange contracts $ —   $ 202   $ —   $ 202   $ —   $ 293   $ —   $ 293

Written currency options —   27   —   27   —   31   —   31

Total liabilities $ —   $ 229   $ —   $ 229   $ —   $ 324   $ —   $ 324

(1)     Investments included in other assets are restricted as to use, including for the payment of benefits under employee benefit plans.

(2)     Balance at March 31, 2026 includes securities with a fair value of $ 17 million that are subject to a contractual sale restriction that expires in July 2026, and securities with a fair value of $ 18 million that are subject to a contractual sale restriction that expires in August 2026.

(3)     The fair value determination of derivatives includes the impact of the credit risk of counterparties to the derivatives and the Company’s own credit risk, the effects of which were not significant.

As of March 31, 2026 and December 31, 2025, Cash and cash equivalents included $ 4.4 billion and $ 13.8 billion of cash equivalents, respectively (which would be considered Level 2 in the fair value hierarchy).

Other Fair Value Measurements

Some of the Company’s financial instruments, such as cash and cash equivalents, receivables and payables, are reflected in the balance sheet at carrying value, which approximates fair value due to their short-term nature.

The estimated fair value of loans payable and long-term debt (including current portion) at March 31, 2026, was $ 44.7 billion compared with a carrying value of $ 49.1 billion and at December 31, 2025, was $ 45.6 billion compared with a carrying value of $ 49.3 billion. Fair value was estimated using recent observable market prices and would be considered Level 2 in the fair value hierarchy.

Concentrations of Credit Risk

On an ongoing basis, the Company monitors concentrations of credit risk associated with corporate and government issuers of securities and financial institutions with which it conducts business. Credit exposure limits are established to limit a concentration with any single issuer or institution. Cash and investments are placed in instruments that meet high credit quality standards as specified in the Company’s investment policy guidelines.

The majority of the Company’s accounts receivable arise from product sales in the U.S. and Europe and are primarily due from drug wholesalers, distributors and retailers, hospitals and government agencies. The Company monitors the financial performance and creditworthiness of its customers so that it can properly assess and respond to changes in their credit profile. The Company also continues to monitor global economic conditions, including the volatility associated with international sovereign economies, and associated impacts on the financial markets and its business.

The Company has accounts receivable factoring agreements with financial institutions in certain countries to sell accounts receivable. The Company factored $ 1.6 billion of accounts receivable as of both March 31, 2026 and December 31, 2025 under these factoring arrangements, which reduced outstanding accounts receivable. The cash received from the financial institutions is reported within operating activities in the Condensed Consolidated Statement of Cash Flows. In certain of these factoring arrangements, for ease of administration, the Company will collect customer payments related to the factored receivables, which it then remits to the financial institutions, generally within thirty days after receipt. As of March 31, 2026 and

  • 17 -

Notes to Condensed Consolidated Financial Statements (unaudited) (continued)

December 31, 2025, the Company had collected $ 39  million and $ 45  million, respectively, on behalf of the financial institutions, which is reflected as restricted cash in Other current assets, and the related obligation to remit the cash is recorded in Accrued and other current liabilities . The net cash flows related to these collections are reported as financing activities in the Condensed Consolidated Statement of Cash Flows. The cost of factoring such accounts receivable was de minimis .

Derivative financial instruments are executed under International Swaps and Derivatives Association master agreements. The master agreements with several of the Company’s financial institution counterparties also include credit support annexes. These annexes contain provisions that require collateral to be exchanged depending on the value of the derivative assets and liabilities, the Company’s credit rating, and the credit rating of the counterparty. Cash collateral received by the Company from various counterparties was $ 89 million and $ 1  million at March 31, 2026 and December 31, 2025, respectively. The obligation to return such collateral is recorded in Accrued and other current liabilities .

6.     Inventories

Inventories consisted of:

($ in millions) March 31, 2026 December 31, 2025

Finished goods $ 2,211   $ 2,275

Raw materials and work in process 11,136   10,645

Supplies 334   331

Total 13,681   13,251

Decrease to LIFO cost ( 1,007 ) ( 912 )

$ 12,674   $ 12,339

Recognized as:

Inventories $ 6,479   $ 6,658

Other Assets 6,195   5,681

Amounts recognized as Other Assets are comprised almost entirely of raw materials and work in process inventories. At March 31, 2026 and December 31, 2025, these amounts included $ 5.8 billion and $ 5.5 billion, respectively, of inventories not expected to be sold within one year. In addition, these amounts included $ 360 million and $ 211 million at March 31, 2026 and December 31, 2025, respectively, of inventories produced in preparation for product launches.

7. Loans Payable

In April 2026, Merck entered into a delayed draw term loan credit agreement (Credit Agreement) pursuant to which the lenders have committed (subject to satisfaction of certain conditions set forth in the Credit Agreement) to provide Merck with financing under a 364-day term loan facility in an aggregate amount not to exceed $ 6.0  billion. Borrowings under the Credit Agreement will bear interest at an annual rate of the SOFR rate plus 0.50 % from the date loans are borrowed (Funding Date) to the date that is 180 days from the Funding Date, and then the SOFR rate plus 0.75 % thereafter. The Company has given required notice to the lenders of its intention to draw down the $ 6.0  billion of funds under the facility, which will be used to fund a portion of the approximately $ 6.7 billion cash consideration for the acquisition of Terns. The Company intends to use the proceeds from a long-term debt financing to repay borrowings under the Credit Agreement.

8.     Contingencies

The Company is involved in various claims and legal proceedings of a nature considered normal to its business, including product liability, intellectual property, commercial litigation, and securities litigation, as well as certain additional matters including governmental and environmental matters. In the opinion of the Company, it is unlikely that the resolution of these matters will be material to the Company’s financial condition, results of operations or cash flows.

Given the nature of the litigation discussed below and the complexities involved in these matters, the Company is unable to reasonably estimate a possible loss or range of possible loss for such matters until the Company knows, among other factors, (i) what claims, if any, will survive dispositive motion practice, (ii) the extent of the claims, including the size of any potential class, particularly when damages are not specified or are indeterminate, (iii) how the discovery process will affect the litigation, (iv) the settlement posture of the other parties to the litigation and (v) any other factors that may have a material effect on the litigation.

The Company records accruals for contingencies when it is probable that a liability has been incurred and the amount can be reasonably estimated. These accruals are adjusted periodically as assessments change or additional information becomes available. Generally, for product liability claims, a portion of the overall accrual is actuarially determined and considers such factors as past experience, number of claims reported and estimates of claims incurred but not yet reported. Individually significant contingent losses are accrued when probable and reasonably estimable. Legal defense costs expected to be incurred in connection with a loss contingency are accrued when probable and reasonably estimable.

  • 18 -

Notes to Condensed Consolidated Financial Statements (unaudited) (continued)

The Company’s decision to obtain insurance coverage is dependent on market conditions, including cost and availability, existing at the time such decisions are made. The Company has evaluated its risks and has determined that the cost of obtaining product liability insurance outweighs the likely benefits of the coverage that is available and, as such, has no insurance for most product liabilities.

Product Liability Litigation

Dr. Scholl’s Foot Powder

As previously disclosed, Merck is a defendant in product liability lawsuits in the U.S. arising from consumers’ alleged exposure to talc in Dr. Scholl’s foot powder, which Merck acquired through its merger with Schering-Plough Corporation and sold as part of the divestiture of Merck’s consumer care business to Bayer in 2014. In these actions, plaintiffs allege that they were exposed to asbestos-contaminated talc and developed mesothelioma as a result. As of March 31, 2026, approximately 735 cases were pending against Merck in various state courts.

The Company was recently the defendant in a trial in Chicago, Illinois, in which it was found to be not liable for the plaintiff’s mesothelioma. The Company anticipates that there will be additional trials in the Dr. Scholl’s litigation in the future.

Gardasil/Gardasil 9

As previously disclosed, Merck is a defendant in product liability lawsuits in the U.S. involving Gardasil (Human Papillomavirus Quadrivalent [Types 6, 11, 16 and 18] Vaccine, Recombinant) and Gardasil 9 (Human Papillomavirus 9-valent Vaccine, Recombinant). As of March 31, 2026, approximately 135 cases were filed and are pending against Merck in either federal or state court. In these actions, plaintiffs allege, among other things, that they suffered various personal injuries after vaccination with Gardasil or Gardasil 9, with postural orthostatic tachycardia syndrome (POTS) as a predominate alleged injury.

In August 2022, the U.S. Judicial Panel on Multidistrict Litigation ordered that Gardasil/Gardasil 9 product liability cases pending in federal courts nationwide be transferred to Judge Robert J. Conrad in the Western District of North Carolina for coordinated pre-trial proceedings. In February 2024, the multidistrict litigation ( Gardasil MDL) was reassigned to Judge Kenneth D. Bell. On March 11, 2025, the court granted Merck’s motion for summary judgment in 16 bellwether cases on implied preemption grounds; plaintiffs have appealed to the Fourth Circuit. The parties’ letter submissions on next steps in the Gardasil MDL proceeding in light of the court’s decision were submitted on April 8, 2025. Expert discovery on the remaining alleged conditions and summary judgment briefing are to follow.

On January 28, 2025, a trial commenced in California state court. Plaintiff claims that she suffers from POTS and fibromyalgia as a result of her Gardasil vaccinations. On February 14, 2025, after several weeks of trial and an opportunity to litigate plaintiff’s claims before a jury, plaintiff’s counsel approached Merck and proposed that the jury be discharged and the case adjourned. Merck agreed, subject to an explicit stipulation that Merck would provide no financial or other consideration in exchange for the agreement to adjourn. The case has been adjourned until a new trial date of July 27, 2026. Merck is vigorously defending this case and believes that evidence presented in court will show that Gardasil had no role in causing any of plaintiff’s conditions.

As previously disclosed, in October 2025, Merck entered into a proposed agreement with plaintiffs’ counsel to substantially resolve the Gardasil product liability litigation. The proposed agreement sets forth various terms and conditions under which Merck would resolve the bulk of all pending Gardasil product liability claims in the U.S. in exchange for a total payment that is considerably less than Merck’s anticipated costs of defense in the litigation and that is not material to Merck. The proposed agreement requires that several conditions be met within specified time periods, including participation thresholds, in order for the proposed agreement to result in a final resolution of any pending litigation.

As previously disclosed, there are fewer than 15 product liability cases pending outside the U.S.

Governmental Proceedings

Civil Investigative Demands

As previously disclosed, in August 2025, the Company received a Civil Investigative Demand (CID) from the U.S. Department of Justice (DOJ), pursuant to a False Claims Act investigation, seeking documents, information, and testimony related to the Company’s programs and practices concerning diversity, equity, and inclusion. The CID states that the DOJ is investigating whether, in connection with the Company’s claims for payments under its federal contracts, the Company falsely certified compliance with federal antidiscrimination laws. The Company is cooperating with the investigation.

As previously disclosed, in June 2024, Merck received a CID from the DOJ, pursuant to a False Claims Act investigation, seeking documents and materials related to Steglatro , Januvia and certain related drugs. The CID states that it is investigating Merck’s price reporting under the Medicaid Drug Rebate Program as well as compliance with anti-kickback requirements in connection with patient assistance programs. The Company is cooperating with the investigation.

Other Matters

As previously disclosed, from time to time, the Company’s subsidiaries in China receive inquiries regarding their operations from various Chinese governmental agencies. Some of these inquiries may be related to matters involving other multinational pharmaceutical companies, as well as Chinese entities doing business with such companies. The Company’s policy is to cooperate with these authorities and to provide responses as appropriate.

  • 19 -

Notes to Condensed Consolidated Financial Statements (unaudited) (continued)

As previously disclosed, from time to time, the Company receives inquiries and is the subject of preliminary investigation activities from competition and other governmental authorities in markets outside the U.S. These authorities may include regulators, administrative authorities, and law enforcement and other similar officials, and these preliminary investigation activities may include site visits, formal or informal requests or demands for documents or materials, inquiries or interviews and similar matters. Certain of these preliminary inquiries or activities may lead to the commencement of formal proceedings. Should those proceedings be determined adversely to the Company, monetary fines and/or remedial undertakings may be required.

Securities Litigation

As previously disclosed, on February 12, 2025, a putative class action was filed against Merck and certain of its officers in the U.S. District Court for the District of New Jersey, captioned Cronin v. Merck & Co., Inc., et al. , purportedly on behalf of all purchasers of Merck common stock between October 26, 2023, and February 3, 2025. Plaintiff alleges that Merck violated federal securities laws by making materially false and misleading statements and omissions regarding demand for Gardasil/Gardasil 9 in China. On December 17, 2025, the court appointed AMF Tjänstepension AB, KBC Asset Management NV, and Wayne County Employees’ Retirement System as lead plaintiffs (Lead Plaintiffs). Lead Plaintiffs filed an amended complaint on February 20, 2026, seeking unspecified damages allegedly caused by the purported false or misleading statements. Defendants filed a motion to dismiss on May 1, 2026. The opposition brief is due June 30, 2026 and the reply brief is due August 14, 2026.

As previously disclosed, various derivative lawsuits were filed in New Jersey state and federal court against certain current and former Merck officers and board members. The derivative lawsuits assert claims under state and federal securities statutes, as well as New Jersey common law, based on the same allegations as those made in the putative securities class action. These derivative lawsuits seek unspecified monetary damages, corporate governance reforms, injunctive relief, disgorgement of profits, restitution, fees, and costs. All the derivative proceedings are stayed pending further developments in the class action.

Commercial and Other Litigation

RotaTeq Antitrust Litigation

As previously disclosed, in March 2023, the Mayor and City Council of Baltimore filed a putative class action against MSD in the Eastern District of Pennsylvania on behalf of all third-party payers in states that indirectly purchased, paid, and/or provided reimbursement for some or all of the purchase price of RotaTeq (Rotavirus Vaccine, Live Oral, Pentavalent), other than for resale, from March 3, 2019 to the present. Plaintiff alleges that MSD violated federal and state antitrust laws and state consumer protection laws. Plaintiff alleges that MSD has implemented an anticompetitive vaccine bundling scheme whereby MSD leverages its alleged monopoly power in certain pediatric vaccine markets to maintain its alleged monopoly power in the U.S. market for rotavirus vaccines in order to charge supracompetitive prices for RotaTeq . Plaintiff seeks permanent injunctive relief and unspecified monetary damages on purchases of RotaTeq , trebled, and fees and costs. In May 2023, MSD moved to dismiss the complaint. In November 2023, the court granted in part and denied in part the motion to dismiss, dismissing plaintiff’s Idaho and Utah consumer law claims and allowing all other claims to proceed.

On January 20, 2026, plaintiff filed a motion to certify the proposed class. On February 10, 2026, Merck filed an opposition to plaintiff’s motion to certify the proposed class and a motion to exclude plaintiff’s expert’s class certification opinions. Plaintiff filed a reply in support of its request to certify the class and an opposition to the motion to exclude on March 17, 2026. On March 31, 2026, Merck filed a reply in support of the motion to exclude plaintiff’s expert’s opinions. Merck also filed a sur-reply to the class certification motion.

Patent Litigation

From time to time, generic and biosimilar manufacturers of pharmaceutical products file abbreviated New Drug Applications (ANDAs) and Biologics License Applications, respectively, with the U.S. Food and Drug Administration (FDA) seeking to market generic and biosimilar forms of the Company’s products prior to the expiration of relevant patents owned by the Company. To protect its patent rights, the Company may file patent infringement lawsuits against such generic and biosimilar companies. Similar lawsuits defending the Company’s patent rights may exist in other countries. The Company intends to vigorously defend its patents, which it believes are valid, against infringement by companies attempting to market products prior to the expiration of such patents. As with any litigation, there can be no assurance of the outcomes, which, if adverse, could result in significantly shortened periods of exclusivity for these products and, with respect to products acquired through acquisitions, potentially significant intangible asset impairment charges. In addition to these matters, the Company may be involved in other litigation involving its intellectual property and intellectual property owned or licensed by other companies.

Bridion — As previously disclosed, between January and November 2020, the Company received multiple Paragraph IV Certification Letters under the Hatch-Waxman Act notifying the Company that generic drug companies had filed applications to the FDA seeking pre-patent expiry approval to sell generic versions of Bridion (sugammadex) Injection. In March, April and December 2020, the Company filed patent infringement lawsuits against those generic companies. The defendants in the New Jersey action referred to below stipulated to infringement of the asserted claims and withdrew all remaining claims and defenses other than a defense seeking to shorten the patent term extension (PTE) of the sugammadex patent to December 2022. The U.S. District Court for the District of New Jersey held a one-day trial in December 2022 on this remaining PTE calculation defense.

As previously disclosed, in June 2023, the U.S. District Court for the District of New Jersey ruled in Merck’s favor. The court held that Merck’s calculation of PTE for the sugammadex patent covering the compound is not invalid and that the U.S.

  • 20 -

Notes to Condensed Consolidated Financial Statements (unaudited) (continued)

Patent & Trademark Office correctly granted a full five-year extension. Also in June 2023, the U.S. District Court for the District of New Jersey issued a final judgment prohibiting the FDA from approving any of the pending or tentatively approved generic applications until January 27, 2026, except for any subsequent agreements between defendants and Merck or further order by the court. In March 2025, the Federal Circuit affirmed the district court’s decision, holding that the patent term extension granted to the sugammadex patent covering Bridion was not invalid and that the patent is entitled to its full five-year patent term extension. In addition, the FDA has now granted Bridion six months of pediatric exclusivity.

While the New Jersey action was pending, the Company settled with five generic companies providing that these generic companies can bring their generic versions of Bridion to the market in January 2026 (which were subject to delay by any applicable pediatric exclusivity which has been granted) or earlier under certain circumstances. Thus, the Federal Circuit’s decision and these settlements secure Bridion ’s exclusivity in the U.S. through July 27, 2026.

Januvia, Janumet, Janumet XR — As previously disclosed, the FDA granted pediatric exclusivity with respect to Januvia (sitagliptin), Janumet (sitagliptin/metformin HCI), and Janumet XR (sitagliptin and metformin HCl extended-release), which provides a further six months of exclusivity in the U.S. beyond the expiration of all patents listed in the FDA’s Orange Book. Adding this exclusivity to the term of the key patent protection extended exclusivity on these products to January 2023. However, Januvia , Janumet , and Janumet XR contain sitagliptin phosphate monohydrate and the Company has another patent covering certain phosphate salt and polymorphic forms of sitagliptin that expires in May 2027, including pediatric exclusivity (salt/polymorph patent).

As previously disclosed, beginning in 2019, a number of generic drug companies filed ANDAs seeking approval of generic forms of Januvia and Janumet along with Paragraph IV certifications challenging the validity of the salt/polymorph patent. The Company has settled with over two dozen generic companies providing that these generic companies can bring their generic versions of Januvia and Janumet to the market in the U.S. in May 2026, and their generic versions of Janumet XR to the market in July 2026 or earlier under certain circumstances.

As a result of these settlement agreements related to the later expiring 2027 salt/polymorph patent directed to the specific sitagliptin salt form of the products, Januvia and Janumet will lose market exclusivity in the U.S. in May 2026 and Janumet XR will lose market exclusivity in the U.S. in July 2026 , although the FDA has approved a non-automatically substitutable form of sitagliptin that differs from the form in the Company’s sitagliptin products .

In March 2024, the Company received another Paragraph IV Certification Letter under the Hatch-Waxman Act from Azurity Pharmaceuticals, Inc. (Azurity) asserting that a different sitagliptin product subject to its ANDA does not infringe the salt/polymorph patent. In May 2024, Merck filed a civil action in the U.S. District Court of Delaware alleging infringement. The case was dismissed without prejudice in July 2024. Following the dismissal, the Company granted Azurity a covenant not to assert the salt/polymorph patent against the Azurity product that is the subject of such ANDA.

Supplementary Protection Certificates (SPCs) for Janumet expired in April 2023 for the majority of European countries. Prior to expiration, generic companies sought revocation of the Janumet SPCs in a number of European countries. In February 2022, a Finnish court referred certain questions to the Court of Justice of the European Union that could impact the validity of the Janumet SPCs in Europe. A decision rendered in December 2024 provides guidance on points of law and does not directly apply to the Janumet SPCs. Thus, additional proceedings in certain countries where generic companies were prevented from launching products during the SPC period may be necessary to determine whether the SPCs are valid and if not, whether damages are appropriate. Those countries include Belgium, Czech Republic, Finland, and France. If the Janumet SPCs are ultimately upheld, the Company has reserved its rights related to the pursuit of damages for those countries where a generic launched prior to expiry of the Janumet SPC.

In October 2023, the Company filed a patent infringement lawsuit against Sawai Pharmaceuticals Co., Ltd. (Sawai) and Medisa Shinyaku Co., Ltd (collectively, Defendants) in the Tokyo District Court seeking an injunction to stop the manufacture, sale and offer for sale of the Defendants’ sitagliptin dihydrogen phosphate product, while the Company’s patents and patent term extensions are in force. The lawsuit is in response to the Defendants’ application for marketing authorization to sell a generic sitagliptin dihydrogen phosphate product, in the anhydride form, which was approved in August 2023. Merck asserts that the Defendants’ activity infringes a patent term extension associated with Merck’s patent directed to the sitagliptin compound patent. In January 2026, the Tokyo District Court orally indicated its view that the extended patent covers Sawai’s tablets. Following this, Sawai conceded to all of the Company’s claims; thus, the case was concluded without a written decision. The relevant PTE for Januvia in Japan expired on March 30, 2026.

Keytruda — As previously disclosed, in November 2022, the Company filed a complaint against The Johns Hopkins University (JHU) in the U.S. District Court of Maryland. This action concerns a joint research collaboration between Merck and JHU regarding the use of Keytruda in certain indications. Merck and JHU partnered to design and conduct a clinical study administering Keytruda to cancer patients having tumors that had the genetic biomarker known as microsatellite instability-high (MSI-H) (the Joint Clinical Study). Subsequently JHU obtained a number of U.S. patents specifically relying on the Joint Clinical Study. Merck alleges that JHU breached the collaboration agreement by obtaining issuance of these patents without informing or involving Merck, which were licensed to others, and then trying to enforce these patents against Merck. Merck, therefore, brought an action for breach of contract, declaratory judgment of noninfringement, and promissory estoppel. JHU answered the complaint in April and May 2023, denying Merck’s claims, and counterclaiming for willful infringement of nine issued U.S. patents, including a demand for damages. Between November 30, 2023, and March 13, 2024, the Company filed inter partes review petitions with the U.S. Patent Office’s Patent Trial and Appeal Board (PTAB), challenging the patentability of all nine patents asserted in the district court. Between June 2024 and October 2024, the PTAB instituted a review of all nine challenged patents. In June 2024,

  • 21 -

Notes to Condensed Consolidated Financial Statements (unaudited) (continued)

the district court granted Merck’s motion to stay the case in its entirety pending the outcome of the PTAB proceeding instituted in June 2024.

As previously disclosed, between June and November 2025, the PTAB issued Final Written Decisions finding all challenged claims of the nine patents unpatentable. JHU has filed notices of appeal to the Federal Circuit Court of Appeals. The district court’s stay is expected to continue until at least the issuance of the Federal Circuit decision.

Subcutaneous Pembrolizumab — As previously disclosed, Halozyme, Inc. (Halozyme) has publicly alleged that certain patents in its modified hyaluronidase (MDASE) portfolio cover an ingredient in the Company’s subcutaneous pembrolizumab product. In November 2024, the Company began filing a series of post grant review (PGR) petitions before the PTAB alleging that certain patents in the MDASE portfolio are invalid. In June 2025, the PTAB instituted the first petition filed by the Company. Since then, the PTAB also instituted 13 additional petitions. An institution decision on one additional patent in the MDASE portfolio is still pending.

In April 2025, Halozyme filed a complaint in the U.S. District Court for the District of New Jersey alleging that the Company’s activities related to subcutaneous pembrolizumab infringe or will infringe 15 patents belonging to the MDASE portfolio, 12 of which are the subject of the Company’s already filed PGR petitions. The Company believes the three patents not challenged via PGR petitions are invalid and suffer from at least the same defects as the patents currently being challenged by the PGR process. In March 2026, the Company filed inter partes review (IPR) petitions against those three patents. The Company expects that the U.S. Patent and Trademark Office will issue an institution decision on these IPR petitions by late-September 2026.

Between August and September 2025, the Company filed revocation actions against EP Patent No. 2 797 622 (the ‘622 patent) owned by Halozyme in the UK, France, Germany and The Netherlands. Halozyme counterclaimed for an injunction in the UK under the ‘622 patent as well as an additional patent but have undertaken not to enforce any injunction there until the validity of both patents, which is in dispute, is finally determined. In October 2025, the Company accepted service of a preliminary injunction filed by Halozyme under the ‘622 patent in Germany. Following a one day hearing in December 2025, a preliminary injunction was awarded against the Company, prohibiting sales in Germany. The Company has appealed the preliminary injunction decision and expects a decision on the appeal in the second or third quarter of 2026. In the Dutch action, in February 2026, Halozyme counterclaimed for infringement including also Belgium, Denmark, France, Ireland, Italy, Sweden and Switzerland. The Dutch action will be heard at the end of July 2026 with a decision expected within three months thereof.

Lenvima — As previously disclosed, between 2019 and 2024, Eisai Inc (Eisai) received Paragraph IV Certification Letters under the Hatch-Waxman Act, providing notice that Sun Pharmaceuticals (Sun), Shilpa Medicare Ltd. (Shilpa), Dr. Reddy’s Laboratories (DRL), and Torrent Pharmaceuticals (Torrent) filed separate applications to the FDA seeking pre-patent expiry approval to sell generic versions of Lenvima (lenvatinib) tablets. Between 2019 and 2024, Eisai and the Company filed a series of patent infringement lawsuits in the U.S. District Court for the District of New Jersey against each generic company asserting several Orange-Book listed patents. The Lenvima compound patent expired in April 2026 (including pediatric exclusivity) and was not challenged. Eisai and the Company settled with Sun, DRL, and Torrent regarding the remaining asserted patents covering Lenvima. Eisai has announced publicly, these generic companies can bring their generic versions of Lenvima to the market in the U.S. in July 2030 or earlier under certain circumstances. In May 2025, Eisai and the Company received a favorable trial decision against Shilpa from the U.S. District Court for the District of New Jersey. As a result of the decision, Shilpa is unable to receive approval from the FDA to sell its generic version of Lenvima until February 2036. Shilpa has appealed the district court’s decision to the U.S. Court of Appeals for the Federal Circuit, and the appeal is currently pending.

Lynparza — As previously disclosed, between December 2022 and November 2024, AstraZeneca Pharmaceuticals LP received Paragraph IV Certification Letters under the Hatch-Waxman Act notifying AstraZeneca that Natco Pharma Limited, Sandoz Inc., Cipla USA, Inc and Cipla Limited (collectively, Cipla), and Zydus Pharmaceuticals (USA) Inc. have filed separate applications to the FDA seeking pre-patent expiry approval to sell generic versions of Lynparza (olaparib) tablet. Between February 2023 and January 2025, AstraZeneca and the Company filed a series of patent infringement lawsuits in the U.S. District Court for the District of New Jersey against each generic company asserting a number of Orange-Book listed patents. The filing of the initial infringement suit generally stays FDA approval for 30 months from the date of the Paragraph IV notice or until an adverse court decision, if any, whichever may occur earlier. In these cases, however, none of the generic companies are challenging the patent specifically claiming the olaparib compound which expires in September 2027. Thus, the earliest date the FDA can approve any of the currently pending generic applications is September 2027. All cases have been consolidated and a trial is now expected in early 2027.

Capvaxive — As previously disclosed, in September 2025, Pogona, LLC filed a complaint in the U.S. District Court for the District of New Jersey alleging that the Company’s activities related to Capvaxive infringe U.S. Patent No. 11,058,757 (‘757 patent). Pogona, LLC is asserting the Company’s infringement is willful and is seeking monetary damages. The Company believes the asserted patent is invalid and not infringed. On January 26, 2026, the Company filed an inter-partes review petition with the U.S. Patent Trial and Appeal Board, challenging the validity of Pogona’s ‘757 patent, which is currently pending.

Other Litigation

There are various other pending legal proceedings involving the Company, principally product liability and intellectual property lawsuits. While it is not feasible to predict the outcome of such proceedings, in the opinion of the Company, either the likelihood of loss is remote or any reasonably possible loss associated with the resolution of such proceedings is not expected to be material to the Company’s financial condition, results of operations or cash flows either individually or in the aggregate.

  • 22 -

Notes to Condensed Consolidated Financial Statements (unaudited) (continued)

Legal Defense Reserves

Legal defense costs expected to be incurred in connection with a loss contingency are accrued when probable and reasonably estimable. Some of the significant factors considered in the review of these legal defense reserves are as follows: the actual costs incurred by the Company; the development of the Company’s legal defense strategy and structure in light of the scope of its litigation; the number of cases being brought against the Company; the costs and outcomes of completed trials; and the most current information regarding anticipated timing, progression, and related costs of pre-trial activities and trials in the associated litigation. The amount of legal defense reserves as of March 31, 2026 and December 31, 2025 of approximately $ 270 million and $ 245 million, respectively, represents the Company’s best estimate of the minimum amount of defense costs to be incurred in connection with its outstanding litigation; however, events such as additional trials and other events that could arise in the course of its litigation could affect the ultimate amount of legal defense costs to be incurred by the Company. The Company will continue to monitor its legal defense costs and review the adequacy of the associated reserves and may determine to increase the reserves at any time in the future if, based upon the factors set forth, it believes it would be appropriate to do so.

9.     Equity

Three Months Ended March 31,

Common Stock Other

Paid-In

Capital Retained

Earnings Accumulated

Other

Comprehensive

Loss  Treasury Stock Non-

controlling

Interests Total

($ and shares in millions except per share amounts) Shares Par Value Shares Cost

Balance at January 1, 2025

3,577   $ 1,788   $ 44,704   $ 63,069   $ ( 4,945 ) 1,049   $ ( 58,303 ) $ 59   $ 46,372

Net income attributable to Merck & Co., Inc.

—  —  —  5,079   —  —  —  —  5,079

Other comprehensive loss, net of taxes —  —  —  —  ( 20 ) —  —  —  ( 20 )

Cash dividends declared on common stock ($ 0.81 per share)

—  —  —  ( 2,051 ) —  —  —  —  ( 2,051 )

Treasury stock shares purchased —  —  —  —  —  13   ( 1,164 ) —  ( 1,164 )

Share-based compensation plans and other —  —  112   —  —  ( 1 ) 66   —  178

Net income attributable to noncontrolling interests —  —  —  —  —  —  —  6   6

Balance at March 31, 2025 3,577   $ 1,788   $ 44,816   $ 66,097   $ ( 4,965 ) 1,061   $ ( 59,401 ) $ 65   $ 48,400

Balance at January 1, 2026

3,577   $ 1,788   $ 45,029   $ 73,075   $ ( 4,287 ) 1,102   $ ( 62,999 ) $ 56   $ 52,662

Net loss attributable to Merck & Co., Inc.

—  —  —  ( 4,240 ) —  —  —  —  ( 4,240 )

Other comprehensive income, net of taxes

—  —  —  —  227   —  —  —  227

Cash dividends declared on common stock ($ 0.85 per share)

—  —  —  ( 2,114 ) —  —  —  —  ( 2,114 )

Treasury stock shares purchased —  —  —  —  —  8   ( 925 ) —  ( 925 )

Share-based compensation plans and other —  —  147   —  —  ( 3 ) 177   —  324

Net loss attributable to noncontrolling interests

—  —  —  —  —  —  —  ( 3 ) ( 3 )

Balance at March 31, 2026 3,577   $ 1,788   $ 45,176   $ 66,721   $ ( 4,060 ) 1,107   $ ( 63,747 ) $ 53   $ 45,931

10.     Pension and Other Postretirement Benefit Plans

The Company has defined benefit pension plans covering eligible employees in the U.S. and in certain of its international subsidiaries. The net periodic benefit cost (credit) of such plans consisted of the following components:

Three Months Ended

March 31,

2026 2025

($ in millions) U.S. International U.S. International

Service cost $ 98   $ 48   $ 89   $ 54

Interest cost 145   81   141   71

Expected return on plan assets ( 207 ) ( 161 ) ( 210 ) ( 143 )

Amortization of unrecognized prior service credit

—   ( 4 ) —   ( 4 )

Net loss (gain) amortization

27   ( 1 ) 13   3

Termination benefits 3   15   —   —

$ 66   $ ( 22 ) $ 33   $ ( 19 )

  • 23 -

Notes to Condensed Consolidated Financial Statements (unaudited) (continued)

The Company provides medical benefits, principally to its eligible U.S. retirees and similar benefits to their dependents, through its other postretirement benefit plans. The net credit of such plans consisted of the following components:

Three Months Ended

March 31,

($ in millions) 2026 2025

Service cost $ 11   $ 10

Interest cost 16   16

Expected return on plan assets ( 14 ) ( 14 )

Amortization of unrecognized prior service credit ( 9 ) ( 10 )

Net gain amortization ( 8 ) ( 10 )

Terminations benefits

1   —

$ ( 3 ) $ ( 8 )

In connection with restructuring actions (see Note 4), termination charges were recorded on pension plans related to expanded eligibility for certain employees exiting Merck.

The components of net periodic benefit cost (credit) other than the service cost component are included in Other (income) expense, net (see Note 11), with the exception of certain amounts for termination benefits which are recorded in Restructuring costs if the event giving rise to the termination benefits related to restructuring actions.

11.     Other (Income) Expense, Net

Other (income) expense, net, consisted of:

Three Months Ended

March 31,

($ in millions) 2026 2025

Interest income $ ( 35 ) $ ( 109 )

Interest expense 479   313

Exchange losses 38   90

Income from investments in equity securities, net (1)

( 168 ) ( 90 )

Net periodic defined benefit plan (credit) cost other than service cost ( 134 ) ( 148 )

Other, net ( 42 ) ( 91 )

$ 138   $ ( 35 )

(1)     Includes net realized and unrealized gains and losses from investments in equity securities either owned directly or through ownership interests in investment funds. Unrealized gains and losses from investments that are owned directly are determined at the end of the reporting period, while gains and losses from ownership interests in investment funds are accounted for on a one quarter lag.

Interest paid for the three months ended March 31, 2026 and 2025 was $ 342 million and $ 233 million, respectively.

12.     Income Taxes

The income tax provision of $ 709 million for the first quarter of 2026 on a pretax loss of $ 3.5 billion, resulted in an effective income tax rate of ( 20.1 )%. The first quarter 2026 effective income tax rate reflects a 33.1 percentage point unfavorable impact of the charge for the acquisition of Cidara, which had no tax benefit, partially offset by the favorable impacts of jurisdictional mix of income and expense. The effective income tax rate of 13.9 % for the first quarter of 2025 reflects the favorable impacts of jurisdictional mix of income and expense, as well as certain discrete items.

The Internal Revenue Service (IRS) is currently conducting examinations of the Company’s tax returns for the years 2017 and 2018, including the one-time transition tax enacted under the Tax Cuts and Jobs Act of 2017. In April 2025, Merck received Notices of Proposed Adjustment (NOPAs) that would increase the amount of the one-time transition tax on certain undistributed earnings of foreign subsidiaries by approximately $ 1.3  billion. In addition, the NOPAs included penalties of approximately $ 260  million. These amounts are exclusive of any interest that may be due. The Company disagrees with the proposed adjustments and will vigorously contest the NOPAs through all available administrative and, if necessary, judicial proceedings. It may take a number of years to reach resolution of this matter. If the Company is ultimately unsuccessful in defending its position, the impact could be material to its financial statements. The statute of limitations for assessments with respect to the 2019 and 2020 federal tax return years expired in June 2024 and October 2024, respectively. The IRS is also currently conducting examinations of the Company’s tax returns for the years 2021 and 2022. In addition, various state and foreign tax examinations are in progress.

  • 24 -

Notes to Condensed Consolidated Financial Statements (unaudited) (continued)

13.     (Loss) Earnings Per Share

The calculations of (loss) earnings per share are as follows:

Three Months Ended

March 31,

($ and shares in millions except per share amounts) 2026 2025

Net (Loss) Income Attributable to Merck & Co., Inc.

$ ( 4,240 ) $ 5,079

Average common shares outstanding 2,472   2,523

Common shares issuable (1)

—   8

Average common shares outstanding assuming dilution 2,472   2,531

Basic (Loss) Earnings per Common Share Attributable to Merck & Co., Inc. Common Shareholders

$ ( 1.72 ) $ 2.01

(Loss) Earnings per Common Share Assuming Dilution Attributable to Merck & Co., Inc. Common Shareholders

$ ( 1.72 ) $ 2.01

(1)      Issuable primarily under share-based compensation plans.

The Company recorded a net loss for the first quarter of 2026; therefore, no potential dilutive common shares were used in the computation of loss per common share assuming dilution because the effect would have been antidilutive. For the first quarter of 2025, 10 million of common shares issuable under share-based compensation plans were excluded from the computation of earnings per common share assuming dilution because the effect would have been antidilutive.

14.     Other Comprehensive Income (Loss)

Changes in each component of other comprehensive income (loss) are as follows:

Three Months Ended March 31,

($ in millions) Derivatives Employee

Benefit

Plans Foreign Currency

Translation

Adjustment Accumulated Other

Comprehensive

Loss

Balance January 1, 2025, net of taxes

$ 242   $ ( 2,327 ) $ ( 2,860 ) $ ( 4,945 )

Other comprehensive income (loss) before reclassification adjustments, pretax ( 201 ) ( 1 ) 200   ( 2 )

Tax 42   —   15   57

Other comprehensive income (loss) before reclassification adjustments, net of taxes ( 159 ) ( 1 ) 215   55

Reclassification adjustments, pretax ( 73 ) (1)

( 10 ) (2)

—   ( 83 )

Tax 15   ( 7 ) —   8

Reclassification adjustments, net of taxes ( 58 )

( 17 )

—   ( 75 )

Other comprehensive income (loss), net of taxes ( 217 ) ( 18 ) 215   ( 20 )

Balance March 31, 2025, net of taxes

$ 25   $ ( 2,345 ) $ ( 2,645 ) $ ( 4,965 )

Balance January 1, 2026, net of taxes

$ ( 105 ) $ ( 1,499 ) $ ( 2,683 ) $ ( 4,287 )

Other comprehensive income (loss) before reclassification adjustments, pretax 168   1   15   184

Tax ( 35 ) 1   ( 9 ) ( 43 )

Other comprehensive income (loss) before reclassification adjustments, net of taxes 133   2   6   141

Reclassification adjustments, pretax 105   (1)

5   (2)

—   110

Tax ( 22 ) ( 2 ) —   ( 24 )

Reclassification adjustments, net of taxes 83

3

—   86

Other comprehensive income (loss), net of taxes 216   5   6   227

Balance March 31, 2026, net of taxes

$ 111   $ ( 1,494 ) $ ( 2,677 ) $ ( 4,060 )

(1)     Primarily relates to foreign currency cash flow hedges that were reclassified from AOCL to Sales .

(2)     Includes net amortization of prior service cost, actuarial gains and losses, settlements and curtailments included in net periodic benefit cost (see Note 10).

15.     Segment Reporting

The Company’s operations are principally managed on a product basis and include two operating segments, Pharmaceutical and Animal Health, both of which are reportable segments.

The Pharmaceutical segment includes human health pharmaceutical and vaccine products. Human health pharmaceutical products consist of therapeutic and preventive agents, generally sold by prescription, for the treatment of human disorders. The Company sells these human health pharmaceutical products primarily to drug wholesalers and retailers, hospitals, government agencies and managed health care providers such as health maintenance organizations, pharmacy benefit managers and other institutions. Human health vaccine products consist of preventive pediatric, adolescent and adult vaccines.

  • 25 -

Notes to Condensed Consolidated Financial Statements (unaudited) (continued)

The Company sells these human health vaccines primarily to physicians, wholesalers, distributors and government entities. A large component of pediatric and adolescent vaccine sales are made to the U.S. Centers for Disease Control and Prevention Vaccines for Children program, which is funded by the U.S. government. Additionally, the Company sells vaccines to the Federal government for placement into vaccine stockpiles.

The Animal Health segment discovers, develops, manufactures and markets a wide range of veterinary pharmaceutical and vaccine products, as well as health management solutions and services, for the prevention, treatment and control of disease in all major livestock and companion animal species. The Company also offers an extensive suite of digitally connected identification, traceability and monitoring products. The Company sells its products to veterinarians, distributors, animal producers, farmers and pet owners.

Sales of the Company’s products were as follows:

Three Months Ended March 31,

2026 2025

($ in millions) U.S. Int’l Total U.S. Int’l Total

Pharmaceutical:

Oncology

Keytruda $ 4,599   $ 3,307   $ 7,906   $ 4,308   $ 2,897   $ 7,205

Keytruda Qlex

106   21   128   —   —   —

Alliance revenue-Lynparza (1)

149   192   341   145   168   312

Alliance revenue-Lenvima (1)

176   80   256   186   72   258

Welireg 152   47   199   123   15   137

Alliance revenue-Reblozyl (2)

128   20   148   101   18   119

Vaccines

Gardasil/Gardasil 9

485   585   1,069   536   790   1,327

ProQuad/M-M-R II /Varivax

409   129   538   423   116   539

RotaTeq 165   42   206   164   64   228

Vaxneuvance 123   78   202   139   92   230

Capvaxive

118   23   142   106   1   107

Cardiometabolic and Respiratory

Winrevair

477   48   525   268   12   280

Ohtuvayre

131   —   131   —   —   —

Alliance revenue-Adempas/Verquvo (3)

109   —   109   97   9   106

Adempas —   78   78   —   68   68

Infectious Diseases

Bridion 427   45   472   378   63   441

Prevymis 135   138   272   102   106   208

Zerbaxa 52   30   82   42   28   70

Delstrigo

10   65   75   15   52   67

Isentress/Isentress HD

35   24   59   51   39   90

Dificid 24   10   34   72   11   83

Lagevrio 16   12   28   35   67   102

Diabetes

Januvia 252   116   367   344   204   549

Janumet 68   139   207   65   182   247

Other pharmaceutical (4)

166   608   775   227   637   865

Total Pharmaceutical segment sales 8,512   5,837   14,349   7,927   5,711   13,638

Animal Health:

Livestock 211   853   1,064   194   730   924

Companion Animal 308   419   727   308   356   664

Total Animal Health segment sales 519   1,272   1,791   502   1,086   1,588

Total segment sales 9,031   7,109   16,140   8,429   6,797   15,226

Other (5)

133   13   146   93   210   303

$ 9,164   $ 7,122   $ 16,286   $ 8,522   $ 7,007   $ 15,529

U.S. plus international may not equal total due to rounding.

(1)     Alliance revenue for Lynparza and Lenvima represents Merck’s share of profits, which are product sales net of cost of sales and commercialization costs (see Note 3).

(2)     Alliance revenue for Reblozyl represents royalties (see Note 3).

(3)     Alliance revenue for Adempas/Verquvo represents Merck’s share of profits from sales in Bayer’s marketing territories, which are product sales net of cost of sales and commercialization costs (see Note 3).

(4)     Other pharmaceutical primarily reflects sales of other human health pharmaceutical products, including products within the franchises not listed separately. Also reflects total alliance revenue for Koselugo of $ 161 million and $ 44  million in the first quarter of 2026 and 2025, respectively (see Note 3).

(5)     Other is primarily comprised of miscellaneous c orpor ate revenue, including revenue hedging activities which (decreased) increa se d sales by $( 110 ) million and $ 58 million for the three months ended March 31, 2026 and 2025, respectively, as well as revenue from third-party manufacturing arrangements (including sales to Organon & Co.). Other for the three months ended March 31, 2026 and 2025 also includes $ 132  million and $ 95  million, respectively, related to milestone payments received by Merck for out-licensing arrangements.

  • 26 -

Notes to Condensed Consolidated Financial Statements (unaudited) (continued)

Product sales are recorded net of the provision for discounts, including chargebacks, which are customer discounts that occur when a contracted customer purchases through an intermediary wholesale purchaser, and rebates that are owed based upon definitive contractual agreements or legal requirements with private sector and public sector (Medicaid and Medicare Part D) benefit providers, after the final dispensing of the product by a pharmacy to a benefit plan participant. These discounts, in the aggregate, reduced U.S. sales by $ 2.5 billion and $ 2.1 billion for the three months ended March 31, 2026 and 2025, respectively.

Consolidated sales by geographic area where derived are as follows:

Three Months Ended

March 31,

($ in millions) 2026 2025

United States $ 9,164   $ 8,522

Europe, Middle East and Africa 3,886   3,454

Latin America 874   792

Asia Pacific (other than China and Japan) 738   689

Japan 555   669

China 390   702

Other 679   701

$ 16,286   $ 15,529

A reconciliation of segment profits to (Loss) Income Before Taxes is as follows:

Three Months Ended March 31,

2026 2025

($ in millions)

Pharma-

ceutical

Animal

Health

Total Pharma-

ceutical

Animal

Health

Total

Segment sales $ 14,349   $ 1,791   $ 16,140   $ 13,638   $ 1,588   $ 15,226

Less segment costs: (1)

Cost of sales 1,553   675   1,573   600

Selling, general and administrative 1,332   282   1,402   260

Research and development (2)

—   112   —   95

Other segment items (3)

( 55 ) —   ( 49 ) ( 1 )

Total segment profits $ 11,519   $ 722   $ 12,241   $ 10,712   $ 634   $ 11,346

Other profits 106   202

Unallocated:

Interest income 35   109

Interest expense ( 479 ) ( 313 )

Amortization ( 931 ) ( 597 )

Depreciation ( 491 ) ( 441 )

Research and development ( 12,404 ) ( 3,477 )

Restructuring costs ( 195 ) ( 69 )

Other unallocated, net ( 1,416 ) ( 857 )

$ ( 3,534 ) $ 5,903

(1)      The significant expense categories and amounts align with the segment level information that is regularly provided to the chief operating decision maker.

(2)      Human health-related research and development expenses incurred by Merck Research Laboratories are not allocated to segment profits as noted below.

(3)      Includes equity (income) loss from affiliates and other miscellaneous non-operating expenses.

Pharmaceutical segment profits consist of segment sales less standard costs, as well as selling, general and administrative expenses directly incurred by the segment. Animal Health segment profits consist of segment sales, less all cost of sales, as well as selling, general and administrative expenses and research and development costs directly incurred by the segment. The chief operating decision maker (Merck’s Chief Executive Officer) uses segment profit for the purpose of evaluating performance, allocating resources, informing incentive compensation targets and setting strategic Company goals during the planning and forecasting process. On a quarterly basis, the CEO considers forecast-to-actual variances in segment profit when assessing performance of the segments and making decisions about allocating resources to the segments. For internal management reporting presented to the chief operating decision maker, Merck does not allocate the remaining cost of sales not included in segment profits as described above, research and development expenses incurred by Merck Research Laboratories, the Company’s research and development division that focuses on human health-related activities, or general and administrative expenses not directly incurred by the segments, nor the cost of financing these activities. Separate divisions maintain responsibility for monitoring and managing these costs, including depreciation related to fixed assets utilized by these divisions and, therefore, they are not included in segment profits. In addition, costs related to restructuring activities, as well as the amortization of intangible assets and the recognition of fair value step-up of inventories are not allocated to segments.

Other profits are primarily comprised of miscellaneous corporate profits, as well as operating profits (losses) related to third-party manufacturing arrangements.

  • 27 -

Notes to Condensed Consolidated Financial Statements (unaudited) (continued)

Other unallocated, net, includes expenses from corporate and manufacturing cost centers, intangible asset impairment charges, gains or losses on sales of businesses, expense or income related to changes in the estimated fair value measurement of liabilities for contingent consideration, and other miscellaneous income or expense items.

Equity income from affiliates and depreciation included in segment profits is as follows:

Three Months Ended March 31,

2026 2025

($ in millions) Pharma-

ceutical

Animal

Health

Total Pharma-

ceutical

Animal

Health

Total

Equity income from affiliates

$ 62   $ —   $ 62   $ 58   $ —   $ 58

Depreciation

1   89   90   1   60   61

Property, plant and equipment, net, by geographic area where located is as follows:

($ in millions)

March 31, 2026 December 31, 2025

United States $ 15,097   $ 15,021

Europe, Middle East and Africa 8,966   8,856

Asia Pacific (other than China and Japan)

842   898

China 213   218

Japan 136   144

Latin America 128   128

Other 51   51

$ 25,433   $ 25,316

The Company does not disaggregate assets on a products and services basis for internal management reporting and, therefore, such information is not presented.

  • 28 -

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

Business Development Transactions

Below is a summary of significant business development activity thus far in 2026.

In March 2026, Merck entered into a definitive agreement to acquire Terns Pharmaceuticals, Inc. (Terns), a clinical-stage oncology company, for $53 per share, for a total transaction value of approximately $6.7 billion. Through this acquisition, Merck will acquire Terns’ lead candidate, TERN-701, a novel investigational oral allosteric BCR::ABL1 tyrosine kinase inhibitor (TKI) currently being evaluated in a Phase 1/2 trial for patients with Philadelphia chromosome-positive, chronic phase chronic myeloid leukemia previously treated with at least one prior TKI and who experienced treatment failure, suboptimal response or treatment intolerance. The transaction has been approved by both Merck’s and Terns’ Boards of Directors. The acquisition is subject to a majority of Terns’ stockholders tendering their shares in the tender offer initiated by Merck in April 2026. The consummation of the proposed transaction is also subject to customary closing conditions. Merck anticipates the transaction will be accounted for as an asset acquisition since TERN-701 is expected to account for substantially all of the fair value of the gross assets to be acquired (excluding cash and deferred income taxes). Upon closing of the transaction, which is anticipated in May 2026, Merck expects to record a charge of approximately $5.8 billion to Research and development expenses, or approximately $2.35 per share. There are no future contingent payments associated with the acquisition. In addition, taking into consideration operational investment to advance TERN-701, as well as the cost of financing the transaction, the Company also anticipates a negative impact of approximately $0.12 per share over the remainder of 2026 following the closing of the transaction.

In January 2026, Merck acquired Cidara Therapeutics, Inc. (Cidara), a biotechnology company developing drug-Fc conjugate (DFC) therapeutics, for $9.2 billion (including $570 million of payments to settle share-based equity awards of which $406 million related to unvested equity awards). Cidara’s lead DFC candidate, MK-1406 (formerly CD388), is a long-acting antiviral designed to prevent seasonal and pandemic influenza. MK-1406 is currently being evaluated in a Phase 3 trial among adult and adolescent participants who are at higher risk of developing complications from influenza. The transaction was accounted for as an asset acquisition since MK-1406 accounted for substantially all of the fair value of the gross assets acquired (excluding cash and deferred income taxes). Merck recorded a charge of $9.0 billion to Research and development expenses, or $3.62 per share, (which primarily represented acquired in-process research and development with no alternative future use), as well as net assets of $332 million in the first quarter of 2026. Under a previous license agreement between Cidara and J&J Innovative Medicine (a Johnson & Johnson company, previously Janssen Pharmaceuticals, Inc.), which was assumed by Merck, J&J Innovative Medicine is eligible to receive regulatory and sales-based milestones related to MK-1406.

Pricing

Global efforts toward health care cost containment continue to exert pressure on product pricing and market access worldwide. Changes to the U.S. health care system as part of health care reform, as well as increased purchasing power of entities that negotiate on behalf of Medicare, Medicaid, and private sector beneficiaries, have contributed to pricing pressure.

In 2021, the U.S. Congress passed the American Rescue Plan Act, which included a provision that eliminated the statutory cap on rebates drug manufacturers pay to Medicaid beginning in January 2024.

In 2022, the U.S. Congress passed the Inflation Reduction Act (IRA), which made significant changes to how drugs are covered and paid for under the Medicare program, including the creation of financial penalties for drugs whose prices rise faster than the rate of inflation, redesign of the Medicare Part D program to require manufacturers to bear more of the liability for certain drug benefits (which went into effect in 2025), and government price-setting for certain Medicare Part D drugs (starting in 2026) and Medicare Part B drugs (starting in 2028). The U.S. Department of Health and Human Services (HHS), through the Centers for Medicare & Medicaid Services (CMS), selected Januvia (sitagliptin) in 2023 for the first year of the IRA’s “Drug Price Negotiation Program” (Program), and selected Janumet (sitagliptin and metformin HCl) and Janumet XR (sitagliptin and metformin HCl extended release) in 2025 for the second year of the IRA’s Program. Pursuant to the IRA’s Program, the government set a price for Januvia , which became effective on January 1, 2026, and set a price for Janumet and Janumet XR , which will become effective on January 1, 2027. In addition, in January 2026, HHS announced that Lenvima (lenvatinib) has been selected for government price setting, the set price for which will become effective on January 1, 2028. Furthermore, the Company expects that Keytruda (pembrolizumab) will be selected in 2027 for government price setting, which would become effective on January 1, 2029. Government price setting may also impact pricing in the private market negatively affecting the Company’s performance. The Company has sued the U.S. government regarding the IRA’s Program.

Additionally, increased utilization of the 340B Federal Drug Discount Program and restrictions on the Company’s ability to identify inappropriate discounts are having a negative impact on Company performance. Furthermore, the Executive Branch and Congress continue to discuss legislation designed to control health care costs, including the cost of drugs. In several international markets, government-mandated pricing actions have reduced prices of generic and patented drugs. In addition, the Company’s sales performance in the first three months of 2026 was negatively affected by other cost-reduction measures taken by governments and other third parties to lower health care costs.

The Company anticipates all of these actions and additional actions in the future will continue to negatively affect sales and profits.

In May 2025, the U.S. presidential administration issued an executive order intended to encourage or impose the use of “most-favored-nation” pricing to tie U.S. prescription drug prices to prices in selected comparably developed nations. In July

  • 29 -

2025, the Company and other pharmaceutical companies received letters from the U.S. presidential administration with a request to agree to the administration’s “most-favored-nation” drug pricing goals by September 29, 2025. Further to the letter received from the administration, in December 2025, the Company announced that it had entered into a three-year agreement (MFN Agreement) with the U.S government that addressed the four policy goals of the administration’s July letter. Included within the MFN Agreement is an obligation by the Company to provide key products through a direct-to-patient program at affordable prices for eligible patients in the U.S. This will initially include Januvia , Janumet and Janumet XR , and will be expanded in the future to include enlicitide decanoate pending FDA approval. The Company also agreed to offer its existing medicines at discounted prices to Medicaid, excluding certain products. Additionally, the Company agreed that products launched during the term of the MFN Agreement (with certain exceptions) will be subject to “most-favored-nation” pricing in reference to prices for such products in a specified group of countries (MFN Countries). Finally, the Company agreed to repatriate and share with the Federal government a portion of foreign revenue received by the Company as a result of the government’s successful trade policy efforts. Additionally, the Company reached an agreement with the U.S. Department of Commerce to delay Section 232 tariffs for three years, enabling the Company to make investments in the U.S. to reshore manufacturing for American patients.

Operating Results

Sales

Three Months Ended

March 31, % Change

Excluding

Foreign

Exchange

($ in millions) 2026 2025 % Change

United States $ 9,164  $ 8,522  8  % 8  %

International 7,122  7,007  2  % (3) %

Total $ 16,286  $ 15,529  5  % 3  %

Worldwide sales were $16.3 billion in the first quarter of 2026, an increase of 5% compared with the first quarter of 2025, reflecting growth in oncology, cardiometabolic and respiratory, and animal health, partially offset by declines in vaccines, diabetes, and infectious diseases.

Growth in the oncology franchise in the first quarter of 2026 was largely due to the performance of Keytruda and Welireg (belzutifan), as well as higher alliance revenue from Koselugo (selumetinib) resulting from an amendment to the collaboration agreement. Sales growth in the cardiometabolic and respiratory franchise was largely attributable to the continued uptake of Winrevair (sotatercept-csrk), as well as the inclusion of sales of Ohtuvayre (ensifentrine) (which was obtained as part of the October 2025 acquisition of Verona Pharma plc [Verona Pharma]). Animal health sales growth was due to the performance of both livestock and companion animal products. The vaccines revenue decline was primarily due to lower combined Gardasil (Human Papillomavirus Quadrivalent [Types 6, 11, 16 and 18] Vaccine Recombinant) and Gardasil 9 (Human Papillomavirus 9-valent Vaccine, Recombinant) sales. The decline in diabetes was primarily due to lower sales of Januvia , and the decline in infectious diseases was largely due to lower sales of Lagevrio (molnupiravir).

See Note 15 to the condensed consolidated financial statements for details on sales of the Company’s products. A discussion of performance for select products in the franchises follows. All product or service marks appearing in type form different from that of the surrounding text are trademarks or service marks owned, licensed to, or distributed by Merck, its subsidiaries or affiliates, except as noted. All other trademarks or service marks are those of their respective owners.

Pharmaceutical Segment

Oncology

Three Months Ended

March 31, % Change

Excluding

Foreign

Exchange

($ in millions) 2026 2025 % Change

Keytruda/Keytruda Qlex

$ 8,034  $ 7,205  12  % 8  %

Alliance Revenue - Lynparza (1)

341  312  9  % 6  %

Welireg 199  137  45  % 43  %

Alliance Revenue - Koselugo (2)

161  44 

Alliance Revenue - Reblozyl (3)

148  119  25  % 25  %

* > 100%

(1)     Alliance revenue for Lynparza represents Merck’s share of profits, which are product sales net of cost of sales and commercialization costs (see Note 3 to the condensed consolidated financial statements).

(2)     Alliance revenue for Koselugo in 2026 primarily includes a $150 million payment received in connection with an amendment to the collaboration agreement with AstraZeneca in August 2025, which revised the payment structure. Alliance revenue in the first quarter of 2025 represents Merck’s share of profits, which are product sales net of cost of sales and commercialization costs. (See Note 3 to the condensed consolidated financial statements for more information on this collaboration, including the above referenced amendment.)

(3)     Alliance revenue for Reblozyl represents royalties (see Note 3 to the condensed consolidated financial statements).

Keytruda is an anti-PD-1 (programmed death receptor-1) therapy that has been approved in over 40 indications in the U.S., including 19 tumor types and 2 tumor-agnostic indications, and has similarly been approved in markets worldwide for many of these indications. Keytruda Qlex is a subcutaneously-administered fixed combination of pembrolizumab and berahyaluronidase alfa, which enhances dispersion and permeability to enable subcutaneous administration of pembrolizumab.

  • 30 -

Keytruda Qlex , which was initially approved by the FDA in September 2025, is approved in the U.S. in solid tumor indications approved for Keytruda . In November 2025, the European Commission (EC) approved a new subcutaneous (SC) route of administration and a new pharmaceutical form (solution for injection) of Keytruda (to be marketed as Keytruda SC ) for use across Keytruda indications for adults in Europe. Timing for commercial availability of Keytruda SC in individual European Union (EU) countries for approved indications will vary by country and depend on multiple factors, including the completion of reimbursement procedures and the outcome of litigation with Halozyme, Inc. as discussed in Note 8 to the condensed consolidated financial statements. The Keytruda and Keytruda Qlex clinical development programs include studies across a broad range of cancer types. See “Research and Development Update” below.

Combined global sales of Keytruda/Keytruda Qlex grew 12% in the first quarter of 2026. Sales growth in the U.S. reflects an approximate $250 million favorable impact due to the timing of wholesaler purchases, higher net pricing, and increased demand. Demand in the U.S. was driven by higher utilization across earlier-stage indications, including in certain types of cervical cancer, triple-negative breast cancer (TNBC), and renal cell carcinoma (RCC), as well as higher demand across multiple metastatic indications, in particular for the treatment of certain types of urothelial and cervical cancers. Sales growth in international markets reflects higher demand in urothelial, non-small cell lung cancer (NSCLC), gastric, cervical, and endometrial cancer metastatic indications, as well as increased uptake predominately for the TNBC, NSCLC, melanoma, and RCC earlier-stage indications. The launch and reimbursement of new indications for Keytruda in the EU continues to have a negative impact on pricing in those markets. In addition, a biosimilar of Keytruda launched in Argentina in 2025 and the Company expects further launches in smaller international markets during 2026. The Company anticipates the impact of biosimilar erosion to Keytruda sales will be immaterial in 2026.

Keytruda has received the following regulatory approvals thus far in 2026.

Date Approval

February 2026

China’s National Medical Products Administration (NMPA) approval for the first-line treatment of certain patients with primary advanced or recurrent endometrial cancer, based on the KEYNOTE-868 (NRG-GY018) trial.

February 2026

U.S. Food and Drug Administration (FDA) approval in combination with paclitaxel, with or without bevacizumab, for the treatment of adult patients with platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal carcinoma whose tumors express programmed death-ligand (PD-L1) Combined Positive Score (CPS) ≥ 1 as determined by an FDA-authorized test, and who have received one or two prior systemic treatment regimens, based on the KEYNOTE-B96 trial.

February 2026

Japan’s Ministry of Health, Labor and Welfare (MHLW) approval for neoadjuvant and adjuvant treatment of locally advanced head and neck squamous cell carcinoma, based on the KEYNOTE-689 trial.

March 2026

EC approval in combination with paclitaxel, with or without bevacizumab, for the treatment of platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal carcinoma in adults whose tumors express PD-L1 (CPS ≥1) and who have received one or two prior systemic treatment regimens, based on the KEYNOTE-B96 trial.

Keytruda Qlex (available in some markets as Keytruda SC ) received the following regulatory approvals thus far in 2026.

Date Approval

February 2026

FDA approval in combination with paclitaxel, with or without bevacizumab, for the treatment of adult patients with platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal carcinoma whose tumors express PD-L1 (CPS ≥ 1) as determined by an FDA-authorized test, and who have received one or two prior systemic treatment regimens, based on the KEYNOTE-B96 trial.

March 2026

EC approval in combination with paclitaxel, with or without bevacizumab, for the treatment of platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal carcinoma in adults whose tumors express PD-L1 (CPS ≥1) and who have received one or two prior systemic treatment regimens, based on the KEYNOTE-B96 trial.

April 2026

FDA approval of a label update based on results from the MK-3475A-F11 trial, which evaluated patient reported preference for subcutaneous administration of Keytruda Qlex over intravenous administration of Keytruda in participants with multiple tumor types.

The Company is a party to license agreements pursuant to which the Company pays royalties on net sales of Keytruda . Under the terms of the more significant of these agreements, Merck pays a royalty of 2.5% on worldwide net sales of Keytruda ; this royalty (which also applies to net sales of Keytruda Qlex) will continue through 2026, terminating thereafter. The Company pays an additional 2% royalty on worldwide net sales of Keytruda (and on Keytruda Qlex following regulatory approval) to another third party; this royalty expired in the U.S. in 2024, expired in major European markets in the second half of 2025, but will continue to be paid on net sales of Keytruda and Keytruda Qlex in certain other international markets expiring at various dates through 2035. The royalty expenses are included in Cost of sales . The Company may be subject to additional royalties on net sales of Keytruda Qlex in the future under certain circumstances.

Lynparza (olaparib) is an oral poly (ADP-ribose) polymerase (PARP) inhibitor being developed and commercialized as part of a collaboration with AstraZeneca PLC (AstraZeneca) (see Note 3 to the condensed consolidated financial statements). Lynparza is approved for the treatment of certain types of advanced or recurrent ovarian, early or metastatic breast, metastatic pancreatic and metastatic castration-resistant prostate cancers. Alliance revenue related to Lynparza grew 9% in the first quarter of 2026 largely due to higher demand in the U.S. and many international markets.

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Sales of Welireg , for the treatment of adult patients with certain von Hippel-Lindau (VHL) disease-associated tumors, certain adult patients with previously treated advanced RCC, and certain patients with pheochromocytoma and paraganglioma, rose 45% in the first quarter of 2026 primarily due to higher demand in the U.S. for the RCC indication and continued launch uptake in several international markets, particularly in Japan and certain European markets.

Koselugo is an oral, selective MEK inhibitor approved for the treatment of patients with neurofibromatosis type 1 who have symptomatic inoperable plexiform neurofibromas. Koselugo is part of a collaboration with AstraZeneca. The increase in alliance revenue in the first quarter of 2026 is due to a $150 million payment received in connection with an amendment to the collaboration agreement in August 2025 that (subject to an annual election by AstraZeneca) discontinued the revenue and cost sharing provisions of the collaboration, and changed the payment structure. See Note 3 to the condensed consolidated financial statements for additional information.

Reblozyl (luspatercept-aamt) is a first-in-class erythroid maturation recombinant fusion protein that is being commercialized through a global collaboration with Bristol-Myers Squibb Company (BMS) (see Note 3 to the condensed consolidated financial statements). Reblozyl is approved for the treatment of anemia in certain rare blood disorders. Alliance revenue related to this collaboration (consisting of royalties) increased 25% in the first quarter of 2026 primarily due to strong underlying sales performance.

Vaccines

Three Months Ended

March 31, % Change

Excluding

Foreign

Exchange

($ in millions) 2026 2025 % Change

Gardasil/Gardasil 9

$ 1,069  $ 1,327  (19) % (22) %

ProQuad 198  121  64  % 60  %

M-M-R II

105  168  (38) % (39) %

Varivax 235  249  (6) % (7) %

Vaxneuvance 202  230  (12) % (16) %

Capvaxive 142  107  33  % 31  %

In January 2026, the acting director of the U.S. Centers for Disease Control and Prevention (CDC) announced changes to the child and adolescent immunization schedule (January announcement), reducing the number of routinely recommended vaccinations and creating three new categories: immunizations recommended for all children; immunizations recommended for certain high-risk groups or populations; and immunizations based on shared clinical decision-making. Immunizations recommended for all children include vaccines for measles, mumps, rubella, polio, pertussis, tetanus, diphtheria, Haemophilus influenzae type B (Hib), pneumococcal disease, human papillomavirus (HPV), and varicella (chickenpox). Immunizations recommended for certain high-risk groups or populations include respiratory syncytial virus (RSV), hepatitis A, hepatitis B, and dengue. Immunizations recommended based on shared clinical decision-making include rotavirus, hepatitis A, and hepatitis B. HHS has stated that immunizations for all of the diseases covered by the previous immunization schedule will still be available to anyone who wants them through Affordable Care Act insurance plans and federal insurance programs, including Medicaid, the Children’s Health Insurance Program, and the Vaccines For Children (VFC) program. Additionally, in September 2025, the trade association representing U.S. health insurers (AHIP) announced that its member health plans would continue to cover all immunizations that had been recommended by the CDC’s Advisory Committee on Immunization Practices (ACIP) as of September 1, 2025, with no cost-sharing for patients through the end of 2026. On March 16, 2026, a federal district court in Massachusetts issued a preliminary injunction staying, among other things, the immunization schedule changes in the CDC’s January announcement. The government is appealing the district court ruling to the U.S. Court of Appeals for the First Circuit.

Combined worldwide sales of Gardasil and Gardasil 9, vaccines to help prevent certain cancers and other diseases caused by certain types of HPV, declined 19% in the first quarter of 2026. The sales decline was primarily driven by lower demand in China (discussed below) and in Japan, reflecting in part that the last date to initiate the first dose in Japan’s national immunization program catch-up cohort was in March 2025. The decline also reflects lower sales in the U.S. primarily due to unfavorable CDC purchasing patterns, partially offset by higher net pricing. As previously disclosed, the Company suspended shipments to China beginning in February 2025 given lower demand and elevated channel inventory levels in China. In April 2026, the Company entered into a revised supply contract with its distributor and commercialization partner in China, Chongqing Zhifei Biological Products Co., Ltd. (Zhifei). Subject to agreement between the parties, the Company may make shipments to China in the latter part of 2026; if so, any associated revenue in 2026 is expected to be immaterial.

Among the changes in the CDC’s now-stayed January announcement referenced above was a reduction of the recommended doses for HPV vaccination of adolescents to a single dose. Gardasil 9 is currently indicated in the U.S. for a two-dose regimen in adolescents aged 9-14 and a three-dose regimen for those aged 15-45. Previous CDC recommendations for adolescents followed FDA-approved dosing. Many countries outside the U.S. have implemented a reduced dosing schedule for HPV vaccination in certain age groups. The Company anticipates that any negative effect of these recommendations or reduced dosing schedules on sales of Gardasil/Gardasil 9 will not be material.

The Company is a party to license agreements pursuant to which the Company pays royalties on net sales of Gardasil/Gardasil 9. Under the terms of the more significant of these agreements, Merck pays a 7% royalty on net sales of

  • 32 -

Gardasil/Gardasil 9 in the U.S. to one third party (this royalty expires in December 2028). The royalty expenses are included in Cost of sales .

Global sales of ProQuad (Measles, Mumps, Rubella and Varicella Virus Vaccine Live), a pediatric combination vaccine to help protect against measles, mumps, rubella and varicella, increased 64% in the first quarter of 2026 primarily due to higher sales in the U.S. As a result of manufacturing delays, in January 2025, the Company borrowed doses of ProQuad from the CDC Pediatric Vaccine Stockpile, which reduced sales of ProQuad by approximately $70 million in the first quarter of 2025. The Company replenished the borrowing later in 2025. Higher demand in certain European markets also contributed to the growth in ProQuad sales in the first quarter of 2026. Worldwide sales of M-M-R II (Measles, Mumps and Rubella Virus Vaccine Live), a vaccine to help protect against measles, mumps and rubella declined 38% in the first quarter of 2026 primarily due to lower sales in the U.S. largely reflecting unfavorable private sector purchasing patterns and lower demand. Global sales of Varivax (Varicella Virus Vaccine Live), a vaccine to help prevent chickenpox (varicella), declined 6% in the first quarter of 2026 primarily due to lower sales in the U.S. largely driven by lower demand, partially offset by higher net pricing.

In September 2025, the ACIP voted to recommend that children under the age of four years receive protection from chickenpox (varicella) as a standalone immunization rather than in combination with measles, mumps, and rubella (MMR) vaccination, eliminating a previous shared clinical decision-making recommendation that allowed parents to choose combined MMR and varicella vaccine first-dose administration. The ACIP also voted to align the VFC program with this change. The acting CDC Director adopted the recommendation in October 2025. These ACIP recommendations are subject to the federal district court’s March 16, 2026 preliminary injunction, as described above. MMR and varicella vaccines remain recommended and funded through the VFC program for both the first and second doses. The Company is the only manufacturer in the U.S. of MMRV vaccine ( ProQuad ) and varicella vaccine ( Varivax ). The Company anticipates that any negative effect of these recommendations on sales of ProQuad will not be material.

Worldwide sales of Vaxneuvance (Pneumococcal 15-valent Conjugate Vaccine), a vaccine to help protect against invasive pneumococcal disease caused by certain serotypes, declined 12% in the first quarter of 2026 primarily due to lower demand in the U.S. and most international markets due to competition. Merck is a party to license agreements pursuant to which the Company pays royalties on net sales of Vaxneuvance . Under the most significant of these agreements, Merck pays a royalty of 7.25% on net sales of Vaxneuvance through 2026; this royalty will decline to 2.5% on net sales from 2027 through 2035. The royalty expenses are included in Cost of sales .

Sales of Capvaxive (Pneumococcal 21-valent Conjugate Vaccine), a vaccine for the prevention of invasive pneumococcal disease and pneumococcal pneumonia caused by certain serotypes in individuals 18 years of age and older, grew 33% in the first quarter of 2026 largely due to launch uptake in certain international markets, particularly in the EU, and continued uptake in the U.S. Sales growth in the U.S. was negatively impacted by a reduction in wholesaler inventory. Capvaxive was approved in the U.S. in June 2024, in the EU in March 2025 and in Japan in August 2025. Merck is a party to license agreements pursuant to which the Company pays royalties on net sales of Capvaxive . Under the terms of the most significant of these agreements, Merck pays a royalty of 7.25% on net sales of Capvaxive through 2026; this royalty will decline to 2.5% on net sales from 2027 through 2035. The royalty expenses are included in Cost of sales.

Enflonsia (clesrovimab-cfor) is a preventive, long-acting monoclonal antibody, for the prevention of RSV lower respiratory tract disease in neonates (newborns) and infants who are born during or entering their first RSV season. Enflonsia was approved in the U.S. in June 2025 and in the EU in April 2026 based on results from the CLEVER and SMART clinical trials. The timing for availability of Enflonsia in individual EU countries will vary by country and depend on multiple factors, including the completion of reimbursement procedures. Sales of Enflonsia were $1 million in the first quarter of 2026 and the Company expects minimal sales of Enflonsia in the second quarter of 2026 given the seasonal nature of the product and continued high levels of RSV monoclonal antibody inventory in the market; however, the Company anticipates that shipments will increase in the second half of 2026.

Cardiometabolic and Respiratory

Three Months Ended

March 31, % Change

Excluding

Foreign

Exchange

($ in millions) 2026 2025 % Change

Winrevair

$ 525  $ 280  88  % 87  %

Ohtuvayre

131  —  —  —

Alliance Revenue - Adempas/Verquvo (1)

109  106  3  % 3  %

Adempas 78  68  15  % 5  %

(1) Alliance revenue for Adempas and Verquvo represents Merck’s share of profits from sales in Bayer AG’s marketing territories, which are product sales net of cost of sales and commercialization costs (see Note 3 to the condensed consolidated financial statements).

Winrevair is an activin signaling inhibitor indicated for the treatment of adults with pulmonary arterial hypertension (PAH) (World Health Organization [WHO] Group 1 pulmonary hypertension) to improve exercise capacity and WHO functional class, and reduce the risk of clinical worsening events including hospitalization for PAH, lung transplantation and death. Sales of Winrevair rose to $525 million in the first quarter of 2026 largely due to continued uptake in the U.S. and early launch uptake in certain international markets, particularly in Japan and Europe. Winrevair was originally approved in the U.S. in March 2024, in the EU in August 2024, and in Japan in June 2025 (where it is being marketed as Airwin ). Winrevair was approved for expanded indications in PAH based on the ZENITH trial in the U.S. in October 2025 and in the EU in January 2026. Winrevair is the subject

  • 33 -

of a licensing agreement pursuant to which Merck pays a 22% royalty on net sales of Winrevair to BMS. The royalty expenses are included in Cost of sales .

Ohtuvayre is an inhaled phosphodiesterases 3 and 4 (PDE3 and PDE4) inhibitor, which was approved in the U.S. in June 2024 for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adults. Ohtuvayre was obtained in conjunction with Merck’s October 2025 acquisition of Verona Pharma.

Adempas (riociguat) and Verquvo (vericiguat) are part of a worldwide collaboration with Bayer AG (Bayer) to market and develop soluble guanylate cyclase (sGC) modulators (see Note 3 to the condensed consolidated financial statements). Adempas is approved for the treatment of certain types of PAH and chronic pulmonary hypertension. Verquvo is approved to reduce the risk of cardiovascular death and heart failure hospitalization following a hospitalization for heart failure or need for outpatient intravenous diuretics in adults with symptomatic chronic heart failure and reduced ejection fraction. Alliance revenue from the collaboration grew 3% in the first quarter of 2026 primarily reflecting higher demand in Bayer’s marketing territories. The Company expects alliance revenue to decline for the full year of 2026 reflecting the loss of market exclusivity for Adempas in the U.S. Revenue also includes sales of Adempas and Verquvo in Merck’s marketing territories. Sales of Adempas in Merck’s marketing territories increased 15% in the first quarter of 2026 largely due to higher demand.

Infectious Diseases

Three Months Ended

March 31, % Change

Excluding

Foreign

Exchange

($ in millions) 2026 2025 % Change

Bridion $ 472  $ 441  7  % 7  %

Prevymis 272  208  31  % 26  %

Dificid

34  83  (59) % (59) %

Lagevrio 28  102  (73) % (73) %

Global sales of Bridion (sugammadex), for the reversal of two types of neuromuscular blocking agents used during surgery, grew 7% in the first quarter of 2026, as higher demand in the U.S. was partially offset by lower demand in most international markets due to generic competition. Bridion will lose market exclusivity in the U.S. in July 2026 . The Company anticipates U.S. sales of Bridion to decline thereafter, depending upon the availability of generic supply. The Company expects to discontinue U.S. sales of Bridion as market supply stabilizes, potentially into 2027.

Worldwide sales of Prevymis (letermovir), a medicine for prophylaxis (prevention) of cytomegalovirus (CMV) infection and disease in certain high risk adult and pediatric recipients of an allogenic hematopoietic stem cell transplant and for prophylaxis of CMV disease in certain high risk adult and pediatric recipients of a kidney transplant, grew 31% in the first quarter of 2026 primarily due to higher demand in the U.S. and certain European markets, reflecting in part the launch of new indications.

Worldwide sales of Dificid (fidaxomicin), a medicine for the treatment of C. difficile -associated diarrhea, declined 59% in the first quarter of 2026 due to generic competition in the U.S. Dificid lost market exclusivity in the U.S. in July 2025; accordingly, the Company is experiencing a significant decline in U.S. sales of Dificid and expects the decline to continue.

Lagevrio is an investigational oral antiviral COVID-19 medicine being developed in a collaboration with Ridgeback Biotherapeutics LP (see Note 3 to the condensed consolidated financial statements). Sales of Lagevrio decreased 73% in the first quarter of 2026 largely due to lower demand in Japan and the U.S. driven primarily by declining COVID-19 cases. The Company expects the Lagevrio sales decline to continue during 2026.

In April 2026, the FDA approved Idvynso , a once-daily, two-drug single-tablet regimen of doravirine, a non-nucleoside reverse transcriptase inhibitor, and islatravir, a next-generation nucleoside analog reverse transcriptase inhibitor, for the treatment of HIV-1 infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no history of virologic treatment failure and no known substitutions associated with resistance to doravarine. Idvynso was also approved in Japan for these patients in March 2026. The approvals were based on the MK-8591A-051 and MK-8591A-052 clinical trials.

Diabetes

Three Months Ended

March 31, % Change

Excluding

Foreign

Exchange

($ in millions) 2026 2025 % Change

Januvia/Janumet $ 574  $ 796  (28) % (29) %

Worldwide combined sales of Januvia and Janumet , medicines that help lower blood sugar levels in adults with type 2 diabetes, declined 28% in the first quarter of 2026 primarily due to lower sales in the U.S. reflecting lower net pricing and ongoing volume declines due to competitive pressure. The sales decline was also attributable to lower demand in China and ongoing generic competition in most other international markets.

While the key U.S. patent for Januvia , Janumet and Janumet XR claiming the sitagliptin compound expired in January 2023, as a result of favorable court rulings and settlement agreements related to a later expiring patent directed to the specific

  • 34 -

sitagliptin salt form of the products, Januvia and Janumet will lose market exclusivity in the U.S. in May 2026 and Janumet XR will lose market exclusivity in the U.S. in July 2026, although a non-automatically substitutable form of sitagliptin that differs from the form in the Company’s sitagliptin products has been approved by the FDA . See Note 8 to the condensed consolidated financial statements for additional information related to the above-referenced patent litigation. Additionally, HHS, through the CMS, selected Januvia in 2023 for the first year of the IRA’s Program, and selected Janumet and Janumet XR in 2025 for the second year of the IRA’s Program. Pursuant to the IRA’s program, the government set a price for Januvia , which became effective on January 1 2026, and set a price for Janumet and Janumet XR, which will become effective on January 1, 2027. The Company has sued the U.S. government regarding the IRA’s Program. The Company expects a significant decline in sales of Januvia in the first half of 2026 and subsequently, following loss of market exclusivity in May 2026, the Company anticipates it will lose nearly all U.S. sales of Januvia and Janumet .

Animal Health Segment

Three Months Ended

March 31, % Change

Excluding

Foreign

Exchange

($ in millions) 2026 2025 % Change

Livestock $ 1,064  $ 924  15  % 8  %

Companion Animal 727  664  9  % 4  %

$ 1,791  $ 1,588  13  % 6  %

Sales of livestock products grew 15% in the first quarter of 2026 primarily due to higher demand for ruminant and poultry products, as well as higher pricing.

Sales of companion animal products grew 9% in the first quarter of 2026 primarily due to new product launches and higher pricing, partially offset by lower demand for other products in the portfolio, reflecting a reduction in veterinary visits. Sales of the Bravecto (fluralaner) line of products were $379 million in the first quarter of 2026, representing growth of 16%, or 9% excluding the effect of foreign exchange, compared with the first quarter of 2025.

In February 2026, the FDA approved Numelvi (atinvicitinib tablets), the first and only second-generation Janus kinase (JAK) inhibitor indicated for the control of pruritus associated with allergic dermatitis in dogs six months of age and older.

Costs, Expenses and Other

Three Months Ended

March 31,

($ in millions) 2026 2025 % Change

Cost of sales $ 4,195  $ 3,419  23  %

Selling, general and administrative 2,700  2,552  6  %

Research and development 12,592  3,621  *

Restructuring costs 195  69  *

Other (income) expense, net 138  (35) *

$ 19,820  $ 9,626  *

* > 100%

Cost of Sales

Cost of sales increased 23% in the first quarter of 2026. Cost of sales includes the amortization of intangible assets recorded in connection with acquisitions, collaborations, and licensing arrangements, which totaled $931 million and $587 million in the first quarter of 2026 and 2025, respectively. Additionally, cost of sales in the first quarter of 2026 includes an $83 million impact for the recognition of fair value step-up of inventories related to the October 2025 acquisition of Verona Pharma. Also included in cost of sales are expenses associated with restructuring activities, which amounted to $237 million and $36 million in the first quarter of 2026 and 2025, respectively, primarily reflecting accelerated depreciation and asset impairment charges related to manufacturing facilities to be fully or partially closed or divested, as well as contractual termination costs. Separation costs associated with manufacturing-related headcount reductions have been incurred and are reflected in Restructuring costs as discussed below.

Gross margin was 74.2% in the first quarter of 2026 compared with 78.0% in the first quarter of 2025. The gross margin decline was primarily due to higher amortization of intangible assets, higher restructuring costs, the recognition of fair value step-up of inventories related to the October 2025 acquisition of Verona Pharma, and the unfavorable effect of foreign exchange, partially offset by the favorable effect of product mix.

Selling, General and Administrative

Selling, general and administrative (SG&A) expenses increased 6% in the first quarter of 2026 primarily due to higher administrative costs and the unfavorable impact of foreign exchange.

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Research and Development

Research and development (R&D) expenses increased to $12.6 billion in the first quarter of 2026 from $3.6 billion in the first quarter of 2025 primarily due to a $9.0 billion charge for the acquisition of Cidara, increased clinical development spending, the unfavorable effect of foreign exchange, and restructuring costs, partially offset by a $200 million reduction in R&D expenses as part of the funding agreement with Blackstone Life Sciences (Blackstone) and a $100 million charge in the first quarter of 2025 for the achievement of a developmental milestone related to the 2024 EyeBiotech Limited (EyeBio) acquisition. See Note 2 to the condensed consolidated financial statements for more information on the acquisition of Cidara and the Blackstone funding agreement.

R&D expenses consist of the costs directly incurred by Merck Research Laboratories (MRL), the Company’s research and development division that focuses on human health-related activities, which were $2.5 billion the first quarter of 2026 (inclusive of a $200 million benefit from the Blackstone funding agreement noted above) and $2.5 billion for the first quarter of 2025. Also included in R&D expenses are Animal Health research costs, upfront and milestone payments for collaboration and licensing agreements (including the charge for the EyeBio developmental milestone noted above), charges for transactions accounted for as asset acquisitions (including the charge for the acquisition of Cidara noted above), and costs incurred by other divisions in support of R&D activities, including depreciation, production, and general and administrative, which in the aggregate were $10.0 billion and $1.1 billion for the first quarter of 2026 and 2025, respectively. R&D expenses also include restructuring costs of $34 million in the first quarter of 2026 primarily associated with contractual termination costs.

Restructuring Costs

In July 2025, the Company approved a restructuring program (2025 Restructuring Program) designed to position the Company for its next chapter of growth and to successfully advance its pipeline and launch new products across multiple therapeutic areas. As part of this program, the Company expects to eliminate certain positions in sales and administrative organizations, as well as research and development. The Company will, however, continue to hire employees into new roles across all strategic growth areas of the business. In addition, the Company will reduce its global real estate footprint and continue to optimize its manufacturing network, aligning the geography of its global manufacturing footprint to its customers and reflecting changes in the Company’s business. Most actions contemplated under the 2025 Restructuring Program are expected to be largely completed by the end of 2027, with the exception of certain manufacturing actions, which are expected to be substantially completed by the end of 2029. The cumulative pretax costs to be incurred by the Company to implement the program are estimated to be approximately $3.0 billion, of which approximately 60% will be cash, relating primarily to employee separation expense and contractual termination costs. The remainder of the costs will be non-cash, relating primarily to the accelerated depreciation of facilities. The Company expects the actions under the 2025 Restructuring Program to result in annual cost savings of approximately $1.7 billion, which will be substantially realized by the end of 2027. The 2025 Restructuring Program is part of the Company’s multiyear optimization initiative anticipated to achieve $3.0 billion in annual cost savings by the end of 2027, which will be fully reinvested into strategic growth areas of the business.

In January 2024, the Company approved a restructuring program (2024 Restructuring Program) intended to continue the optimization of the Company’s Human Health global manufacturing network as the future pipeline shifts to new modalities and also optimize the Animal Health global manufacturing network to improve supply reliability and increase efficiency. The actions contemplated under the 2024 Restructuring Program are expected to be substantially completed by the end of 2031, with the cumulative pretax costs to be incurred by the Company to implement the program estimated to be approximately $4.0 billion. Approximately 50% of the cumulative pretax costs will be non-cash, relating primarily to the accelerated depreciation of facilities to be closed or divested. The remainder of the costs will result in cash outlays, relating primarily to facility shut-down costs. The Company anticipates the actions under the 2024 Restructuring Program will result in cumulative annual net cost savings of approximately $750 million by the end of 2031.

Restructuring costs of $195 million and $69 million for the first quarter of 2026 and 2025, respectively, primarily include separation and other costs associated with these restructuring activities. Separation costs incurred were associated with actual headcount reductions, as well as estimated expenses under existing severance programs for involuntary headcount reductions that were probable and could be reasonably estimated. Other expenses in Restructuring costs include facility shut-down and other related costs, as well as employee-related costs such as curtailment, settlement, and termination charges associated with pension and other postretirement benefit plans and share-based compensation plan costs. For segment reporting, restructuring costs are unallocated expenses.

Additional costs associated with the Company’s restructuring activities are included in Cost of sales , Selling, general and administrative expenses and Research and development costs. The Company recorded aggregate pretax costs of $466 million and $105 million in the first quarter of 2026 and 2025, respectively, related to restructuring program activities. See Note 4 to the condensed consolidated financial statements for additional details.

Other (Income) Expense, Net

Other (income) expense, net, was $138 million of expense in the first quarter of 2026 compared with $35 million of income in the first quarter of 2025. The unfavorable quarter-over-quarter change was primarily due to higher net interest expense, partially offset by higher net income from investments in equity securities (primarily due to the Company’s investment in Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.).

  • 36 -

For details on the components of Other (income) expense, net see Note 11 to the condensed consolidated financial statements.

Segment Profits

Three Months Ended

March 31,

($ in millions) 2026 2025

Pharmaceutical segment profits $ 11,519  $ 10,712

Animal Health segment profits 722  634

Non-segment activity

(15,775) (5,443)

(Loss) Income Before Taxes

$ (3,534) $ 5,903

Pharmaceutical segment profits consist of segment sales less standard costs, as well as SG&A expenses directly incurred by the segment. Animal Health segment profits consist of segment sales, less all cost of sales, as well as SG&A and R&D expenses directly incurred by the segment. For internal management reporting presented to the chief operating decision maker, Merck does not allocate the remaining cost of sales not included in segment profits as described above, R&D expenses incurred by MRL, or general and administrative expenses not directly incurred by the segments, nor the cost of financing these activities. Separate divisions maintain responsibility for monitoring and managing these costs, including depreciation related to fixed assets utilized by these divisions and, therefore, they are not included in segment profits. Also excluded from the determination of segment profits are costs related to restructuring activities and acquisition- and divestiture-related costs, including the amortization of intangible assets and the recognition of fair value step-up of inventories, intangible asset impairment charges, and expense or income related to changes in the estimated fair value measurement of liabilities for contingent consideration. Additionally, segment profits do not reflect other expenses from corporate and manufacturing cost centers and other miscellaneous income or expense. These unallocated items are reflected in “Non-segment activity” in the above table. Also included in “Non-segment activity” are miscellaneous corporate profits (losses), as well as operating profits (losses) related to third-party manufacturing arrangements.

Taxes on Income

The income tax provision of $709 million for the first quarter of 2026 on a pretax loss of $3.5 billion, resulted in an effective income tax rate of (20.1)%. The first quarter 2026 effective income tax rate reflects a 33.1 percentage point unfavorable impact of the charge for the acquisition of Cidara, which had no tax benefit, partially offset by the favorable impacts of jurisdictional mix of income and expense. The effective income tax rate of 13.9% for the first quarter of 2025 reflects the favorable impacts of jurisdictional mix of income and expense, as well as certain discrete items.

The Internal Revenue Service (IRS) is currently conducting examinations of the Company’s tax returns for the years 2017 and 2018, including the one-time transition tax enacted under the Tax Cuts and Jobs Act of 2017. In April 2025, Merck received Notices of Proposed Adjustment (NOPAs) that would increase the amount of the one-time transition tax on certain undistributed earnings of foreign subsidiaries by approximately $1.3 billion. In addition, the NOPAs included penalties of approximately $260 million. These amounts are exclusive of any interest that may be due. The Company disagrees with the proposed adjustments and will vigorously contest the NOPAs through all available administrative and, if necessary, judicial proceedings. It may take a number of years to reach resolution of this matter. If the Company is ultimately unsuccessful in defending its position, the impact could be material to its financial statements. The statute of limitations for assessments with respect to the 2019 and 2020 federal tax return years expired in June 2024 and October 2024, respectively. The IRS is also currently conducting examinations of the Company’s tax returns for the years 2021 and 2022. In addition, various state and foreign tax examinations are in progress.

Non-GAAP (Loss) Income and Non-GAAP EPS

Non-GAAP (loss) income and non-GAAP (loss) earnings per share (EPS) are alternative views of the Company’s performance that Merck is providing because management believes this information enhances investors’ understanding of the Company’s results since management uses non-GAAP measures to assess performance. Non-GAAP (loss) income and non-GAAP EPS exclude certain items because of the nature of these items and the impact that they have on the analysis of underlying business performance and trends. The excluded items (which should not be considered non-recurring) consist of acquisition- and divestiture-related costs, restructuring costs, income and losses from investments in equity securities, and certain other items. These excluded items are significant components in understanding and assessing financial performance.

Non-GAAP (loss) income and non-GAAP EPS are important internal measures for the Company. Senior management receives a monthly analysis of operating results that includes a non-GAAP EPS metric. Management uses non-GAAP measures internally for planning and forecasting purposes and to measure the performance of the Company along with other metrics. In addition, annual employee compensation, including senior management’s compensation, is derived in part using a non-GAAP pretax income metric. Since non-GAAP (loss) income and non-GAAP EPS are not measures determined in accordance with GAAP, they have no standardized meaning prescribed by GAAP and, therefore, may not be comparable to the calculation of similar measures of other companies. The information on non-GAAP (loss) income and non-GAAP EPS should be considered in addition to, but not as a substitute for or superior to, net (loss) income and EPS prepared in accordance with generally accepted accounting principles in the U.S. (GAAP).

  • 37 -

A reconciliation between GAAP financial measures and non-GAAP financial measures is as follows:

Three Months Ended

March 31,

($ in millions except per share amounts) 2026 2025

(Loss) income before taxes as reported under GAAP

$ (3,534) $ 5,903

Increase (decrease) for excluded items:

Acquisition- and divestiture-related costs 1,046  647

Restructuring costs 466  105

Income from investments in equity securities, net

(180) (107)

Non-GAAP (loss) income before taxes

(2,202) 6,548

Income tax provision as reported under GAAP 709  818

Estimated tax benefit on excluded items (1)

248  113

Non-GAAP income tax provision 957  931

Non-GAAP net (loss) income

(3,159) 5,617

Less: Net (loss) income attributable to noncontrolling interests as reported under GAAP

(3) 6

Non-GAAP net (loss) income attributable to Merck & Co., Inc.

$ (3,156) $ 5,611

EPS assuming dilution as reported under GAAP (2)(3)

$ (1.72) $ 2.01

EPS difference 0.44  0.21

Non-GAAP EPS assuming dilution (2)(3)

$ (1.28) $ 2.22

(1)     The estimated tax impact on the excluded items is determined by applying the statutory rate of the originating territory of the non-GAAP adjustments.

(2)     GAAP and non-GAAP EPS were negatively affected in the first quarter of 2026 by a charge of $3.62 per share for a transaction accounted for as an asset acquisition. See “Business Development Transactions” above for additional information.

(3)     The Company recorded a net loss on both a GAAP and non-GAAP basis for the first quarter of 2026; therefore, no potential dilutive common shares were used in the computations of loss per common share assuming dilution because the effects would have been antidilutive.

Acquisition- and Divestiture-Related Costs

Non-GAAP (loss) income and non-GAAP EPS exclude the impact of certain amounts recorded in connection with acquisitions and divestitures of businesses. These amounts include the amortization of intangible assets and the recognition of fair value step-up of inventories, as well as intangible asset impairment charges, and expense or income related to changes in the estimated fair value measurement of liabilities for contingent consideration. Also excluded are integration, transaction, and certain other costs associated with acquisitions and divestitures. Non-GAAP income and non-GAAP EPS also exclude amortization of intangible assets related to collaborations, asset acquisitions, and licensing arrangements, as well as the recognition of fair value step-up of inventories related to asset acquisitions.

Restructuring Costs

Non-GAAP (loss) income and non-GAAP EPS exclude costs related to restructuring actions (see Note 4 to the condensed consolidated financial statements). These amounts include employee separation costs and accelerated depreciation associated with facilities to be fully or partially closed or divested. Accelerated depreciation costs represent the difference between the depreciation expense to be recognized over the revised useful life of the asset, based upon the anticipated date the site will be closed or divested or the equipment disposed of, and depreciation expense as determined utilizing the useful life prior to the restructuring actions. Restructuring costs also include asset impairment, facility shut-down, contractual termination, and other related costs, as well as employee-related costs such as curtailment, settlement, and termination charges associated with pension and other postretirement benefit plans and share-based compensation costs.

Income and Losses from Investments in Equity Securities

Non-GAAP (loss) income and non-GAAP EPS exclude realized and unrealized gains and losses from investments in equity securities either owned directly or through ownership interests in investment funds.

Certain Other Items

Non-GAAP (loss) income and non-GAAP EPS exclude certain other items. These items are adjusted for after evaluating them on an individual basis, considering their quantitative and qualitative aspects. Typically, these items are unusual in nature, significant to the results of a particular period or not indicative of future operating results. There were no such items in either the first quarter of 2026 or 2025.

Research and Development Update

The Company currently has several candidates under regulatory review in the U.S. and internationally.

MK-1654, Enflonsia , a prophylactic long-acting monoclonal antibody designed to protect infants from RSV disease during their first RSV season, is under review in Japan. The application is based on results from the Phase 2b/3 CLEVER trial and the Phase 3 SMART trial.

MK-2400, ifinatamab deruxtecan (I-DXd), an investigational, potential first-in-class B7-H3 directed DXd antibody drug conjugate (ADC), is under priority review in the U.S. for the treatment of adult patients with previously treated extensive-stage

  • 38 -

small cell lung cancer who experienced disease progression on or after platinum-based chemotherapy. The FDA set a Prescription Drug User Fee Act (PDUFA) target action date of October 10, 2026. The biologics license application (BLA) is based on results from the Phase 2 IDeate-Lung01 trial. I-DXd is being developed as part of a collaboration with Daiichi Sankyo.

MK-0616, enlicitide decanoate, an investigational once-daily oral proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, is under review in the EU for the treatment of adults with primary hypercholesterolemia or mixed dyslipidemia. The application is based on the Phase 3 CORALreef Lipids, CORALreef HeFH, and CORALreef AddOn studies. Enlicitide decanoate is in Phase 3 development in the U.S. In December 2025, the FDA selected enlicitide decanoate for the Commissioner’s National Priority Voucher (CNPV) pilot program, which offers the ability to seek expedited approval for a drug or biologic application or efficacy supplement. Pilot program eligibility requires alignment with one or more critical national health priorities, which include addressing a health crisis in the U.S., bringing innovative therapies to the American people, addressing a large unmet medical need, promoting domestic manufacturing, and increasing affordability. The pilot program is intended to enable enhanced communications with the FDA and action on an application within one to two months. The CNPV process for enlicitide decanoate is progressing.

MK-3475, Keytruda , is an anti-PD-1 therapy available for intravenous administration. MK-3475A, Keytruda Qlex , combines pembrolizumab with berahyaluronidase alfa to enhance dispersion and permeability to enable subcutaneous administration. Keytruda and Keytruda Qlex each are approved for the treatment of many cancers and continue to be studied in additional Phase 3 trials.

Keytruda is under review in Japan in combination with chemotherapy with or without bevacizumab for the treatment of certain patients with platinum-resistant recurrent ovarian cancer. The application is based on data from the Phase 3 KEYNOTE-B96 trial.

Keytruda also is under review in the EU and Japan in combination with Padcev (enfortumab vedotin) as neoadjuvant treatment, then continued after radical cystectomy as adjuvant treatment, for patients with muscle invasive bladder cancer (MIBC) who are ineligible for cisplatin-based chemotherapy. The application is based on data from the Phase 3 KEYNOTE-905 trial conducted in collaboration with Pfizer Inc. (Pfizer) and Astellas.

Keytruda and Keytruda Qlex are under priority review by the FDA in combination with Padcev as neoadjuvant treatment, then continued after radical cystectomy as adjuvant treatment, for patients with MIBC who are eligible for cisplatin-based chemotherapy. The FDA set a PDUFA date of August 17, 2026. The supplemental BLAs are based on data from the Phase 3 KEYNOTE-B15 trial conducted in collaboration with Pfizer and Astellas.

Keytruda and Keytruda Qlex also are under review by the FDA in combination with Gilead Sciences Inc.’s (Gilead) Trodelvy (sacituzumab govitecan) for the first-line treatment of certain patients with unresectable locally advanced or metastatic TNBC whose tumors express PD‑L1. The FDA set PDUFA dates in the second half of 2026 for these applications. The supplemental BLAs are based on data from the Phase 3 KEYNOTE-D19 trial conducted in collaboration with Gilead.

MK-6482, Welireg , Merck’s first-in-class oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, in combination with Keytruda or Keytruda Qlex is under priority review by the FDA for the adjuvant treatment of certain patients with clear cell RCC following nephrectomy. The FDA set a PDUFA date of June 19, 2026. The supplemental applications for Welireg , Keytruda and Keytruda Qlex are based on data from the Phase 3 LITESPARK-022 trial.

Welireg , in combination with MK-7902, Lenvima, an orally available multiple receptor TKI, is under review in the U.S. and Japan for the treatment of certain previously treated patients with advanced RCC. In the U.S., the FDA set a PDUFA date of October 4, 2026. The supplemental applications for Welireg and Lenvima are based on data from the Phase 3 LITESPARK-011 trial. Lenvima is being developed as part of a collaboration with Eisai Co., Ltd.

MK-7962, Winrevair , an activin signaling inhibitor for the treatment of adults with PAH (WHO Group 1 pulmonary hypertension), is under review by the FDA in connection with a proposed update to the U.S. product label based on the results of the Phase 3 HYPERION trial. The FDA set a PDUFA date of September 21, 2026. Additionally, in March 2026, the Company announced the presentation of positive data from the Phase 2, proof-of-concept CADENCE trial of Winrevair ; the Company intends to proceed with Phase 3 development of Winrevair for the treatment of combined post- and precapillary pulmonary hypertension due to heart failure with preserved ejection fraction.

A pre-specified interim analysis of the Phase 3 LITESPARK-012 study found that, compared to Keytruda plus Lenvima, the triplet combination regimen of Keytruda plus Lenvima plus Welireg , as well as the combination regimen of MK-1308A (an investigational fixed dose coformulation of Keytruda and the anti-CTLA-4 antibody quanvonlimab) plus Lenvima, did not show a statistically significant improvement in the dual primary endpoints of progression-free survival and overall survival in patients with advanced clear cell RCC. Separately, the Company has decided to end the MK-1308A clinical development program and will prioritize the development of other candidates in its comprehensive and diversified oncology pipeline. This decision is not based on any concerns about the safety of that fixed-dose coformulation.

In the Phase 3 KEYNOTE-975 study, compared to placebo plus definitive chemoradiotherapy (dCRT), Keytruda plus dCRT did not show a statistically significant improvement in the primary endpoint of event-free survival (EFS) in certain patients with locally advanced unresectable esophageal carcinoma. Also, a pre-specified interim analysis of the Phase 3 KEYNOTE-866 study found that, compared to perioperative placebo plus neoadjuvant chemotherapy, perioperative Keytruda plus neoadjuvant chemotherapy did not show a statistically significant improvement in the primary endpoint of EFS in patients with cisplatin-eligible MIBC who underwent radical cystectomy and pelvic lymph node dissection.

  • 39 -

The chart below reflects the Company’s research pipeline as of April 30, 2026. Candidates shown in Phase 3 include the date such candidate entered into Phase 3 development. Candidates shown in Phase 2 include the most advanced compound with a specific mechanism or, if listed compounds have the same mechanism, they are each currently intended for commercialization in a given therapeutic area. Small molecules and biologics generally are given MK-number designations and vaccine candidates generally are given V-number designations. Except as otherwise noted, candidates in Phase 1, additional indications in the same therapeutic area (other than with respect to cancer, immunology and certain other indications) and additional claims, line extensions or formulations for in-line products are not shown.

Phase 2

Alzheimer’s Disease

MK-1167

MK-2214

Atherosclerosis

MK-7262

Cancer

MK-1022 (patritumab deruxtecan) (1)

Biliary

Bladder

Cervical

Endometrial

Esophageal

Gastric

Hepatocellular

Melanoma

Non-Small Cell Lung

Ovarian

Pancreatic

Prostate

MK-1084 (calderasib) (1)

Solid Tumors

MK-2400 (ifinatamab deruxtecan) (1)

Biliary

Bladder

Breast

Cervical

Endometrial

Head and Neck

Hepatocellular

Melanoma

Non-Small Cell Lung

Ovarian

Pancreatic

Solid Tumors

Cancer

MK-2870 (sacituzumab tirumotecan) (1)

Biliary

Esophageal

Neoplasm Malignant

Pancreatic

MK-3120

Bladder

MK-3475 Keytruda

Prostate

MK-3475A Keytruda Qlex

Hematological Malignancies (U.S.)

MK-5684 (opevesostat)

Breast

Endometrial

Ovarian

MK-5909 (raludotatug deruxtecan) (1)

Cervical

Endometrial

Gastric

Non-Small Cell Lung

Renal Cell

Small Cell Lung

MK-6070 (gocatamig) (1)

Small Cell Lung

MK-6482 Welireg

Breast

Cancer

V940 (intismeran autogene) (1)

Bladder

Renal Cell

Chronic Obstructive Pulmonary Diseases

MK-5884A (ensifentrine+glycopyrrolate)

HIV-1 Infection

MK-8591B (islatravir+ulonivirine)

Immunology

MK-7240 (tulisokibart)

Axial Spondyloarthritis

Hidradenitis Suppurativa

Psoriatic Arthritis

Rheumatoid Arthritis

Systemic Sclerosis

MK-8690

Ulcerative Colitis

Metabolic Dysfunction-Associated Steatohepatitis (MASH)

MK-6024 (efinopegdutide)

Pulmonary Hypertension-Chronic Obstructive Pulmonary Disease

MK-5475

Pulmonary Hypertension Due To Left Heart Disease

MK-7962 Winrevair

  • 40 -

Phase 3 (Phase 3 entry date) Under Review

Cancer

MK-1022 (patritumab deruxtecan) (1)

Breast (July 2025)

MK-1026 (nemtabrutinib)

Hematological Malignancies (March 2023)

MK-1084 (calderasib) (1)

Colorectal (July 2025)

Non-Small Cell Lung (May 2024)

MK-2140 (zilovertamab vedotin)

Hematological Malignancies (September 2024)

MK-2400 (ifinatamab deruxtecan) (1)

Esophageal (March 2025)

Prostate (May 2025)

Small Cell Lung (EU) (July 2024)

MK-2870 (sacituzumab tirumotecan) (1)

Bladder (April 2026)

Breast (April 2024)

Cervical (July 2024)

Endometrial (December 2023)

Gastric (May 2024)

Non-Small Cell Lung (November 2023)

Ovarian (April 2025)

MK-3475 Keytruda

Small-Cell Lung (May 2017)

MK-3543 (bomedemstat)

Myeloproliferative Disorders (December 2023)

MK-5909 (raludotatug deruxtecan) (1)

Ovarian (December 2025)

MK-5684 (opevesostat)

Prostate (December 2023)

MK-7339 Lynparza (1)

Non-Small Cell Lung (June 2019)

Small Cell Lung (December 2020)

V940 (intismeran autogene) (1)

Melanoma (July 2023)

Non-Small Cell Lung (December 2023)

COVID-19

MK-4482 Lagevrio (U.S.) (May 2021) (1)(2)

Dengue Fever Virus Vaccine

V181 (June 2025)

Diabetic Macular Edema

MK-3000 (3)

HIV-1 Infection

MK-8591A (doravirine+islatravir) (February 2020) ( EU )

MK-8591D (islatravir+lenacapavir) (October 2024) (1)(4)

HIV-1 Pre-Exposure Prophylaxis

MK-8527 (July 2025)

Hypercholesterolemia

MK-0616 (enlicitide decanoate) (U.S.) (August 2023)

Immunology

MK-7240 (tulisokibart)

Crohn’s Disease (June 2024)

Ulcerative Colitis (October 2023)

Influenza

MK-1406 (September 2025)

Neovascular Age-Related Macular Degeneration

MK-8748 (5)

New Molecular Entities

Previously Treated Extensive-Stage Small Cell Lung Cancer

MK-2400 (ifinatamab deruxtecan) (U.S.) (1)

Primary Hypercholesterolemia or Mixed Dyslipidemia

MK-0616 (enlicitide decanoate) (EU)

Respiratory Syncytial Virus

MK-1654 Enflonsia (JPN)

Certain Supplemental Filings

Cancer

MK-3475 Keytruda

• Platinum-Resistant Recurrent Ovarian Cancer

(KEYNOTE-B96) (JPN)

• Cisplatin-Ineligible Muscle Invasive Bladder Cancer

(KEYNOTE-905) (EU) (JPN)

• Cisplatin-Eligible Muscle Invasive Bladder Cancer

(KEYNOTE-B15) (U.S.)

• First-Line Unresectable Locally Advanced or Metastatic Triple Negative Breast Cancer

(KEYNOTE-D19) (U.S.)

MK-3475A Keytruda Qlex

• Cisplatin-Eligible Muscle Invasive Bladder Cancer

(KEYNOTE-B15) (U.S.)

• First-Line Unresectable Locally Advanced o r Metastatic Triple Negative Breast Cancer

(KEYNOTE-D19) (U.S.)

MK-6482 Welireg

• Clear Cell Renal Cell Carcinoma Following Nephrectomy

(LITESPARK-022) (U.S.) (6)

• Previously Treated Advanced Renal Cell Carcinoma

(LITESPARK-011) (U.S.) (JPN) (1)

Pulmonary Arterial Hypertension

MK-7962 Winrevair (HYPERION) (U.S.)

Footnotes:

(1) Being developed in a collaboration.

(2) Available in the U.S. under Emergency Use Authorization.

(3) Program is in Phase 2/3 studies, the first of which commenced in August 2024.

(4) On FDA partial clinical hold for higher doses of islatravir than those used in current clinical trials.

(5) Program is in Phase 2/3 studies, the first of which commenced in March 2026.

(6) Under review for combination use with Keytruda or Keytruda Qlex.

Analysis of Liquidity and Capital Resources

($ in millions) March 31, 2026 December 31, 2025

Cash and investments $ 6,807  $ 15,521

Working capital 8,070  15,189

Total debt to total liabilities and equity 38.2  % 36.0  %

Cash provided by operating activities was $3.9 billion in the first three months of 2026 compared with $2.5 billion in the first three months of 2025. Cash provided by operating activities continues to be the Company’s primary source of funds to finance operating needs, with excess cash serving as the primary source of funds to finance business development transactions, capital expenditures, dividends paid to shareholders and treasury stock purchases. Larger business development transactions may be funded with a combination of cash from operating activities and debt.

Cash used in investing activities was $10.2 billion in the first three months of 2026 compared with $1.5 billion in the first three months of 2025. The higher use of cash in investing activities was primarily due to the acquisition of Cidara and no proceeds from sales of securities and other investments, partially offset by lower capital expenditures (driven in part by the acquisition of a facility from WuXi Vaccines in 2025) and lower purchases of securities and other investments.

Cash used in financing activities was $3.0 billion in the first three months of 2026 compared with $5.8 billion in the first three months of 2025. The lower use of cash in financing activities was primarily due to lower payments on long-term debt, an increase in short-term borrowings, lower purchases of treasury stock and higher proceeds from the exercise of stock options, partially offset by higher dividends paid to shareholders.

In January 2026 and February 2026, the Company’s $135 million, 6.30% debentures, and its $1.0 billion, 0.75% notes, respectively, matured in accordance with their terms and were repaid. In February 2025, the Company’s $2.5 billion, 2.75% notes matured in accordance with their terms and were repaid.

  • 41 -

In April 2026, Merck entered into a delayed draw term loan credit agreement (Credit Agreement) pursuant to which the lenders have committed (subject to satisfaction of certain conditions set forth in the Credit Agreement) to provide Merck with financing under a 364-day term loan facility in an aggregate amount not to exceed $6.0 billion. Borrowings under the Credit Agreement will bear interest at an annual rate of the SOFR rate plus 0.50% from the date loans are borrowed (Funding Date) to the date that is 180 days from the Funding Date, and then the SOFR rate plus 0.75% thereafter. The Company has given required notice to the lenders of its intention to draw down the $6.0 billion of funds under the facility, which will be used to fund a portion of the approximately $6.7 billion cash consideration for the acquisition of Terns. The Company intends to use the proceeds from a long-term debt financing to repay borrowings under the Credit Agreement.

Dividends paid to stockholders were $2.1 billion in both the first three months of 2026 and 2025. In November 2025, Merck’s Board of Directors declared a quarterly dividend of $0.85 per share on the Company’s outstanding common stock for the first quarter of 2026 that was paid in January 2026. In January 2026, Merck’s Board of Directors declared a quarterly dividend of $0.85 per share on the Company’s outstanding common stock for the second quarter of 2026 that was paid in April 2026.

In January 2025, Merck’s Board of Directors authorized purchases of up to $10 billion of Merck’s common stock for its treasury. The treasury stock purchase authorization has no time limit and will be made over time in open-market transactions, block transactions on or off an exchange, or in privately negotiated transactions. During the first three months of 2026, the Company purchased $874 million (8 million shares) of its common stock for its treasury under this program. The Company expects to repurchase approximately $3.0 billion of treasury shares under this program during 2026. As of March 31, 2026, the Company’s remaining share repurchase authorization was $6.4 billion.

The Company has a $6.0 billion credit facility that matures in May 2030. The facility provides backup liquidity for the Company’s commercial paper borrowing facility and is to be used for general corporate purposes. The Company has not drawn funding from this facility.

Critical Accounting Estimates

The Company’s significant accounting policies, which include management’s best estimates and judgments, are included in Note 2 to the consolidated financial statements for the year ended December 31, 2025 included in Merck’s Form 10‑K filed on February 24, 2026. A discussion of accounting estimates considered critical because of the potential for a significant impact on the financial statements due to the inherent uncertainty in such estimates is included in the Critical Accounting Estimates section of Management’s Discussion and Analysis of Financial Condition and Results of Operations included in Merck’s Form 10-K. There have been no significant changes in the Company’s critical accounting estimates since December 31, 2025.

Recently Issued Accounting Standards

For a discussion of recently issued accounting standards, see Note 1 to the condensed consolidated financial statements.

Item 3. Quantitative and Qualitative Disclosures about Market Risk

There have been no material changes in market risk exposures that affect the disclosures presented in “Item 7A. Quantitative and Qualitative Disclosures about Market Risk” in the Company’s 2025 Form 10-K filed on February 24, 2026.

Item 4. Controls and Procedures

Management of the Company, with the participation of its Chief Executive Officer and Chief Financial Officer, has evaluated the effectiveness of the Company’s disclosure controls and procedures over financial reporting. Based on their evaluation, the Company’s Chief Executive Officer and Chief Financial Officer have concluded that as of March 31, 2026, the Company’s disclosure controls and procedures are effective. For the first quarter of 2026, there were no changes in internal control over financial reporting that materially affected, or are reasonably likely to materially affect, the Company’s internal control over financial reporting.

CAUTIONARY FACTORS THAT MAY AFFECT FUTURE RESULTS

This report and other written reports and oral statements made from time to time by the Company may contain so-called “forward-looking statements,” all of which are based on management’s current expectations and are subject to risks and uncertainties which may cause results to differ materially from those set forth in the statements. One can identify these forward-looking statements by their use of words such as “anticipates,” “expects,” “plans,” “will,” “estimates,” “forecasts,” “projects” and other words of similar meaning, or negative variations of any of the foregoing. One can also identify them by the fact that they do not relate strictly to historical or current facts. These statements are likely to address the Company’s growth strategy, financial results, product approvals, product potential, or development programs. One must carefully consider any such statement and should understand that many factors could cause actual results to differ materially from the Company’s forward-looking statements. These factors include inaccurate assumptions and a broad variety of other risks and uncertainties, including some that are known and some that are not. No forward-looking statement can be guaranteed and actual future results may vary materially.

The Company does not assume the obligation to update any forward-looking statement. One should carefully evaluate such statements in light of factors, including risk factors, described in the Company’s filings with the Securities and

  • 42 -

Exchange Commission, especially on Forms 10-K, 10-Q and 8-K. In Item 1A. “Risk Factors” of the Company’s Annual Report on Form 10‑K for the year ended December 31, 2025, filed on February 24, 2026, the Company discusses in more detail various important risk factors that could cause actual results to differ from expected or historic results. The Company notes these factors for investors as permitted by the Private Securities Litigation Reform Act of 1995. One should understand that it is not possible to predict or identify all such factors. Consequently, the reader should not consider any such list to be a complete statement of all potential risks or uncertainties.

PART II - Other Information

Item 1. Legal Proceedings

The information called for by this Item is incorporated herein by reference to Note 8 included in Part I, Item 1, Financial Statements (unaudited) — Notes to Condensed Consolidated Financial Statements.

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds

Issuer purchases of equity securities for the three months ended March 31, 2026 were as follows:

ISSUER PURCHASES OF EQUITY SECURITIES

($ in millions)

Period Total Number

of Shares

Purchased (1)

Average Price

Paid Per

Share Total Number of Shares

Purchased as Part of

Publicly Announced Plans or

Programs

Approximate Dollar Value of Shares

That May Yet Be Purchased

Under the Plans or Programs (1)

January 1 - January 31

3,283,324  $108.62 3,283,324  $6,964

February 1 - February 28

2,254,286  $119.10 2,254,286  $6,696

March 1 - March 31

2,121,980  $117.17 2,121,980  $6,447

Total 7,659,590  $114.07 7,659,590

(1) Shares purchased during the period were made as part of a plan approved by the Board of Directors in January 2025 to purchase up to $10 billion of Merck’s common stock for its treasury.

Item 5. Other Information

Insider Trading Arrangements

During the three months ended March 31, 2026, none of the Company’s directors or executive officers adopted or terminated a “Rule 10b5-1 trading arrangement” or “non-Rule 10b5-1 trading arrangement,” as each item is defined in Item 408 of Regulation S-K.

  • 43 -

Item 6. Exhibits

Number    Description

3.1 — Restated Certificate of Incorporation of Merck & Co., Inc. (November 3, 2009) – Incorporated by reference to Merck & Co., Inc.'s Current Report on Form 8-K filed on November 4, 2009 (No. 1-6571)

3.2 — By-Laws of Merck & Co., Inc. (effective November 19. 2024) – Incorporated by reference to Merck & Co., Inc.'s Current Report on Form 8-K filed on November 22, 2024 (No. 1-6571)

31.1  — Rule 13a – 14(a)/15d – 14(a) Certification of Chief Executive Officer

31.2  — Rule 13a – 14(a)/15d – 14(a) Certification of Chief Financial Officer

32.1  — Section 1350 Certification of Chief Executive Officer

32.2  — Section 1350 Certification of Chief Financial Officer

101.INS — XBRL Instance Document - The instance document does not appear in the interactive data file because its XBRL tags are embedded within the Inline XBRL document.

101.SCH — XBRL Taxonomy Extension Schema Document.

101.CAL — XBRL Taxonomy Extension Calculation Linkbase Document.

101.DEF — XBRL Taxonomy Extension Definition Linkbase Document.

101.LAB — XBRL Taxonomy Extension Label Linkbase Document.

101.PRE — XBRL Taxonomy Extension Presentation Linkbase Document.

104  — Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101).

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Signatures

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

MERCK & CO., INC.

Date: May 4, 2026   /s/ Jennifer Zachary

JENNIFER ZACHARY

Executive Vice President and General Counsel

Date: May 4, 2026   /s/ Dalton Smart

DALTON SMART

Senior Vice President Finance - Global Controller

  • 45 -
打开原文

安进增长组合对冲专利压力

重要性3/5 中

AMGN 官方财报直接覆盖标的的收入结构、现金流和重点管线,但发布已超过两个月,主要提供日报背景。

中文摘要

核心结论

安进(Amgen,股票代码 AMGN)2026 年第一季度收入同比增长 6% 至 86 亿美元,16 个品牌实现两位数增长;Repatha、UPLIZNA、IMDELLTRA 等增长产品正在填补 Prolia、Enbrel 与 XGEVA 面临仿制药和定价压力后的收入缺口。公司维持全年收入 371 亿至 385 亿美元指引,同时继续投入 MariTide 肥胖症项目的三期临床,增长质量仍需接受价格、库存和后续临床数据检验。

重要性评级

评级:3/5(中)

这是 AMGN 的官方一季报,财务、产品销售和临床管线信息密度高,且与标的直接相关;但发布日期为 04/30,距 07/11 日报已有滞后,适合作为公司基本面背景。

关键事实

  • 2026 年第一季度总收入为 86 亿美元,同比增长 6%;产品销售增长 4%,其中销量增长 9%,净售价下降 2%,库存水平变化拖累 2%。
  • 美国通用会计准则(GAAP)每股收益为 3.34 美元,同比增长 4%;调整后每股收益为 5.15 美元,同比增长 5%。GAAP 营业利润率升至 32.4%,调整后营业利润率降 0.4 个百分点至 45.3%。
  • Repatha(降脂单抗产品)销售额 8.76 亿美元,同比增长 34%;UPLIZNA(罕见病抗体药物)销售额 2.62 亿美元,同比增长 188%;IMDELLTRA(小细胞肺癌疗法)销售额 2.58 亿美元,同比增长 219%。
  • Prolia(骨质疏松症药物)销售额同比下降 34% 至 7.27 亿美元,XGEVA(肿瘤骨相关治疗药物)下降 27% 至 4.11 亿美元;公司预计多款生物类似药上市将加速这两项产品在 2026 年的销售流失。Enbrel(炎症治疗药物)下降 37% 至 3.20 亿美元,公告归因于医保 D 部分价格设定和 340B 药品折扣计划渠道结构变化等因素。
  • 第一季度自由现金流为 15 亿美元,上年同期为 10 亿美元;截至 03/31,现金及等价物为 120 亿美元,未偿债务为 573 亿美元。
  • 全年指引为收入 371 亿至 385 亿美元、GAAP 每股收益 15.62 至 17.10 美元、调整后每股收益 21.70 至 23.10 美元,资本开支约 26 亿美元,回购上限 30 亿美元。
  • MariTide(每月或更低频给药的肥胖症候选药物)多项三期研究正在进行或招募,包括体重管理、心血管结局、心力衰竭、睡眠呼吸暂停及换药方案;公司计划在 2026 年启动 3 项糖尿病人群三期研究。

作者观点与证据

公司管理层将业绩描述为增长品牌足以穿越专利到期与竞争加剧的阶段。支持材料包括收入、销量、单品销售、现金流和三期管线进展;该表述来自公司新闻稿,产品前景、全年指引和临床时间表属于管理层预期,未包含独立市场份额、处方数据或临床终点结果。

与相关标的的关系

AMGN 的收入结构正由 Repatha、罕见病和新肿瘤产品支撑,同时承受 denosumab 系列产品及 Enbrel 下滑。MariTide 的三期项目覆盖范围扩大,构成中长期研发变量;其疗效、安全性、完成时间和商业化结果尚未在本公告中给出。

时效性与限制

公告发布于 04/30(未给出具体时刻),由安进发布,属于一手财务和管线披露;截至 07/11 已不是新近业绩事件。原文提取供受保护的内部报告阅读,公告未提供竞争产品的可比数据,也未验证全年指引和临床计划能否实现。

后续跟踪

  • Repatha、UPLIZNA、IMDELLTRA 的销量、净售价与库存变化。
  • Prolia、XGEVA 生物类似药竞争下的季度销售流失速度。
  • MariTide 各项三期研究的入组、数据读出和安全性披露。
  • 全年收入与利润率相对指引的执行情况,以及债务与自由现金流变化。
原文
Amgen Reports First Quarter 2026 Financial Results

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Press Releases

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AMGEN REPORTS FIRST QUARTER 2026 FINANCIAL RESULTS

THOUSAND OAKS, Calif. , April 30, 2026 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced financial results for the first quarter of 2026.

"Our first quarter results demonstrate the strength of our business, with 16 brands achieving double-digit growth, enabling us to grow through expected patent expirations and increased competition. With a new wave of molecules progressing in Phase 3 clinical development, we're confident in our ability to deliver attractive long-term growth," said Robert A. Bradway , chairman and chief executive officer.

Key results include:

  • For the first quarter, total revenues increased 6% to $8.6 billion in comparison to the first quarter of 2025.
  • Product sales grew 4%, driven by 9% volume growth, partially offset by 2% lower net selling price and 2% from lower inventory levels.
  • Sixteen products delivered at least double-digit sales growth in the first quarter.
  • Seventeen products annualizing at more than $1 billion based on first quarter sales.
  • GAAP earnings per share (EPS) increased 4% from $3.20 to $3.34 for the first quarter, driven by higher operating income, partially offset by net unrealized losses on equity investments in the current-year period compared to net unrealized gains in the prior-year period.
  • For the first quarter, GAAP operating income increased from $1.2 billion to $2.7 billion , and GAAP operating margin increased 17.4 percentage points to 32.4%.
  • Non-GAAP EPS increased 5% from $4.90 to $5.15 for the first quarter, driven by higher revenues, partially offset by higher operating expenses.
  • For the first quarter, non-GAAP operating income increased from $3.6 billion to $3.7 billion , and non-GAAP operating margin decreased 0.4 percentage points to 45.3%.
  • The Company generated $1.5 billion of free cash flow for the first quarter of 2026 versus $1.0 billion for the first quarter of 2025, driven by business performance and timing of working capital, partially offset by higher capital expenditures.

References in this release to "non-GAAP" measures, measures presented "on a non-GAAP basis," and "free cash flow" (computed by subtracting capital expenditures from operating cash flow) refer to non-GAAP financial measures. Adjustments to the most directly comparable GAAP financial measures and other items are presented on the attached reconciliations. Refer to Non-GAAP Financial Measures below for further discussion.

Product Sales Performance

General Medicine

  • Repatha ® (evolocumab) sales increased 34% year-over-year to $876 million in the first quarter, driven by 35% volume growth and 8% favorable changes to estimated sales deductions, partially offset by 7% lower net selling price.
  • EVENITY ® (romosozumab-aqqg) sales increased 27% year-over-year to $562 million in the first quarter, driven by volume growth.
  • Prolia ® (denosumab) sales decreased 34% year-over-year to $727 million in the first quarter, primarily driven by 17% lower volume, 10% lower net selling price, and 4% from lower inventory levels. For 2026, we continue to expect accelerated sales erosion driven by increased competition, as multiple biosimilars have launched globally.

Rare Disease

  • TEPEZZA ® (teprotumumab-trbw) sales increased 29% year-over-year to $490 million in the first quarter, driven by a 22% impact from higher inventory levels and higher net selling price.
  • KRYSTEXXA ® (pegloticase) sales increased 8% year-over-year to $255 million in the first quarter, primarily driven by 20% higher net selling price, partially offset by 8% from lower inventory levels and unfavorable changes to estimated sales deductions.
  • UPLIZNA ® (inebilizumab-cdon) sales increased 188% year-over-year to $262 million in the first quarter, primarily driven by volume growth.
  • TAVNEOS ® (avacopan) sales increased 32% year-over-year to $119 million in the first quarter, driven by 55% volume growth, partially offset by 15% from lower inventory levels.

Inflammation

  • TEZSPIRE ® (tezepelumab-ekko) sales increased 20% year-over-year to $343 million in the first quarter, driven by 32% volume growth, partially offset by 8% from lower inventory levels.
  • Otezla ® (apremilast) sales decreased 1% year-over-year to $431 million in the first quarter, as 8% lower net selling price and 2% lower volume were offset by favorable changes to estimated sales deductions.
  • Enbrel ® (etanercept) sales decreased 37% year-over-year to $320 million in the first quarter, primarily driven by unfavorable changes to estimated sales deductions of 18% and 15% lower net selling price. The decline in net selling price reflects the impact of U.S. Medicare Part D price setting under the Inflation Reduction Act, effective January 1, 2026 , as well as an increased 340B Program mix.
  • AMJEVITA ® (adalimumab-atto)/AMGEVITA™ (adalimumab) sales increased 27% year-over-year to $173 million in the first quarter, primarily driven by 18% higher net selling price and 8% favorable foreign exchange impact.
  • PAVBLU ® (aflibercept-ayyh) generated $280 million in the first quarter. Sales increased 9% quarter-over-quarter, driven by 16% volume growth, partially offset by 9% from lower inventory levels.

Oncology

  • BLINCYTO ® (blinatumomab) sales increased 12% year-over-year to $415 million in the first quarter, driven by 19% volume growth, partially offset by unfavorable changes to estimated sales deductions.
  • IMDELLTRA ® (tarlatamab-dlle)/IMDYLLTRA™ (tarlatamab) sales increased 219% year-over-year to $258 million in the first quarter, driven by volume growth.

Vectibix ® (panitumumab) sales increased 7% year-over-year to $287 million in the first quarter, driven by 11% volume growth, partially offset by lower inventory levels.

  • KYPROLIS ® (carfilzomib) sales increased 2% year-over-year to $330 million in the first quarter, primarily driven by higher net selling price.
  • LUMAKRAS ® /LUMYKRAS™ (sotorasib) sales increased 11% year-over-year to $94 million in the first quarter, driven by volume growth.
  • Nplate ® (romiplostim) sales increased 32% year-over-year to $412 million in the first quarter. Excluding the U.S. government order of $60 million in the first quarter of 2026, Nplate sales increased 12%, driven by 8% volume growth and higher net selling price.
  • XGEVA ® (denosumab) sales decreased 27% year-over-year to $411 million in the first quarter, driven by 19% lower volume and lower net selling price. For 2026, we continue to expect accelerated sales erosion driven by increased competition, as multiple biosimilars have launched globally.
  • MVASI ® (bevacizumab-awwb) sales decreased 16% year-over-year to $150 million in the first quarter, driven by 8% lower net selling price and 7% unfavorable changes to estimated sales deductions.

Established Products

  • Our established products, which consist of Aranesp ® (darbepoetin alfa) , Neulasta ® (pegfilgrastim) and Parsabiv ® (etelcalcetide) , generated $563 million of sales in the first quarter. Sales increased 1% year-over-year, driven by 10% higher net selling price, partially offset by 4% lower volume and 4% unfavorable changes to estimated sales deductions.

Product Sales Detail by Product and Geographic Region

$Millions, except percentages

Q1 '26

Q1 '25

YOY Δ

U.S

ROW

TOTAL

TOTAL

TOTAL

Repatha ®

$ 465

$ 411

$ 876

$ 656

34 %

EVENITY ®

431

131

562

442

27 %

Prolia ®

461

266

727

1,099

(34 %)

TEPEZZA ®

424

66

490

381

29 %

KRYSTEXXA ®

255

255

236

8 %

UPLIZNA ®

246

16

262

91

*

TAVNEOS ®

114

5

119

90

32 %

Ultra-Rare products (1)

96

2

98

179

(45 %)

TEZSPIRE ®

343

343

285

20 %

Otezla ®

352

79

431

437

(1 %)

Enbrel ®

314

6

320

510

(37 %)

AMJEVITA ® /AMGEVITA ™

41

132

173

136

27 %

PAVBLU ®

276

4

280

99

*

WEZLANA ® /WEZENLA ™

4

43

47

150

(69 %)

BLINCYTO ®

221

194

415

370

12 %

IMDELLTRA ® /IMDYLLTRA ™

188

70

258

81

*

Vectibix ®

136

151

287

267

7 %

KYPROLIS ®

218

112

330

324

2 %

LUMAKRAS ® /LUMYKRAS ™

49

45

94

85

11 %

Nplate ®

283

129

412

313

32 %

XGEVA ®

228

183

411

566

(27 %)

MVASI ®

96

54

150

179

(16 %)

Aranesp ®

77

234

311

340

(9 %)

Neulasta ®

149

16

165

129

28 %

Parsabiv ®

43

44

87

88

(1 %)

Other products (2)

263

52

315

340

(7 %)

Total product sales

$ 5,773

$ 2,445

$ 8,218

$ 7,873

4 %

* Change in excess of 100%

(1) Ultra-Rare products consist of PROCYSBI ® , RAVICTI ® , ACTIMMUNE ® , BUPHENYL ® and QUINSAIR ® .

(2) Other products consist of Aimovig ® , KANJINTI ® , AVSOLA ® , BKEMV ® /BEKEMV ™ , RIABNI ® , EPOGEN ® , NEUPOGEN ® , IMLYGIC ® , Sensipar ® /Mimpara ™ , RAYOS ® , DUEXIS ® , Corlanor ® , and PENNSAID ® . Biosimilars total $185 million in Q1 '26 and $171 million in Q1 '25. Rare Disease total ($3) million in Q1 '26 and ($1) million in Q1 '25.

Operating Expense, Operating Margin and Tax Rate Analysis

On a GAAP basis:

  • Total Operating Expenses decreased 15% year-over-year for the first quarter. Cost of Sales as a percentage of product sales decreased 4.3 percentage points, driven by lower amortization expense from acquisition-related assets, partially offset by higher profit share and royalty expense and changes in our sales mix. Research & Development (R&D) expenses increased 16% driven by higher spend in Later-Stage Clinical Programs, including those related to MariTide. Selling, General & Administrative (SG&A) expenses decreased 5% driven by lower general and administrative expenses, partially offset by higher commercial product-related expenses. Other operating income for the first quarter included litigation settlements.
  • Operating Margin as a percentage of product sales increased 17.4 percentage points to 32.4%.
  • Tax Rate increased 0.4 percentage points for the first quarter primarily driven by the change in earnings mix, including lower amortization expense from acquisition-related assets, partially offset by the net unrealized losses on our equity investments in the current-year period compared to net unrealized gains in the prior-year period.

On a non-GAAP basis:

  • Total Operating Expenses increased 8% year-over-year for the first quarter. Cost of Sales as a percentage of product sales increased 1.5 percentage points, driven by higher profit share and royalty expense and changes in our sales mix. R&D expenses increased 16% driven by higher spend in Later-Stage Clinical Programs, including those related to MariTide. SG&A expenses decreased 4% driven by lower general and administrative expenses, partially offset by higher commercial product-related expenses.
  • Operating Margin as a percentage of product sales decreased 0.4 percentage points for the first quarter to 45.3%.
  • Tax Rate decreased 1.0 percentage points for the first quarter primarily driven by net favorable items in the current-year period, partially offset by the change in earnings mix.

$Millions, except percentages

GAAP

Non-GAAP

Q1 '26

Q1 '25

YOY Δ

Q1 '26

Q1 '25

YOY Δ

Cost of Sales

$ 2,744

$ 2,968

(8 %)

$ 1,603

$ 1,420

13 %

% of product sales

33.4 %

37.7 %

(4.3) pts

19.5 %

18.0 %

1.5 pts

Research & Development

$ 1,719

$ 1,486

16 %

$ 1,711

$ 1,475

16 %

% of product sales

20.9 %

18.9 %

2.0 pts

20.8 %

18.7 %

2.1 pts

Selling, General & Administrative

$ 1,602

$ 1,687

(5 %)

$ 1,583

$ 1,655

(4 %)

% of product sales

19.5 %

21.4 %

(1.9) pts

19.3 %

21.0 %

(1.7) pts

Other

$ (113)

$ 830

*

$ —

$ —

N/A

Total Operating Expenses

$ 5,952

$ 6,971

(15 %)

$ 4,897

$ 4,550

8 %

Operating Margin

Operating income as % of product sales

32.4 %

15.0 %

17.4 pts

45.3 %

45.7 %

(0.4) pts

Tax Rate

12.7 %

12.3 %

0.4 pts

13.6 %

14.6 %

(1.0) pts

pts: percentage points

* = Change in excess of 100%

N/A = not applicable

Cash Flow and Balance Sheet

  • The Company generated $1.5 billion of free cash flow in the first quarter of 2026 versus $1.0 billion in the first quarter of 2025, driven by business performance and timing of working capital, partially offset by higher capital expenditures.
  • The Company declared a first quarter 2026 dividend on December 9, 2025 of $2.52 per share that was paid on March 6, 2026 to all stockholders of record as of February 13, 2026 , representing a 6% increase from the same period in 2025.
  • During the first quarter of 2026, there were no repurchases of shares of common stock under our stock repurchase program.
  • Cash and cash equivalents totaled $12.0 billion and debt outstanding totaled $57.3 billion as of March 31, 2026 .

$Billions, except shares

Q1 '26

Q1 '25

YOY Δ

Operating Cash Flow

$ 2.2

$ 1.4

$ 0.8

Capital Expenditures

$ 0.7

$ 0.4

$ 0.3

Free Cash Flow

$ 1.5

$ 1.0

$ 0.5

Dividends Paid

$ 1.4

$ 1.3

$ 0.1

Share Repurchases

$ 0.0

$ 0.0

$ 0.0

Average Diluted Shares (millions)

544

541

3

Note: Numbers may not add due to rounding

$Billions

3/31/26

12/31/25

YTD Δ

Cash and Cash Equivalents

$ 12.0

$ 9.1

$ 2.9

Debt Outstanding

$ 57.3

$ 54.6

$ 2.7

Note: Numbers may not add due to rounding

2026 Guidance

For the full year 2026, the Company expects:

  • Total revenues in the range of $37 .1 billion to $38 .5 billion.
  • On a GAAP basis, EPS in the range of $15.62 to $17.10 , and a tax rate in the range of 14.5% to 16.0%.
  • On a non-GAAP basis, EPS in the range of $21.70 to $23.10 , and a tax rate in the range of 15.0% to 16.5%.
  • Capital expenditures to be approximately $2 .6 billion.
  • Share repurchases not to exceed $3 .0 billion.

First Quarter Product and Pipeline Update

The Company provided the following updates on selected product and pipeline programs:

General Medicine

MariTide (maridebart cafraglutide, AMG 133)

  • MariTide is a differentiated antibody-peptide conjugate that activates the glucagon-like peptide-1 ( GLP-1 ) receptor and antagonizes the glucose-dependent insulinotropic polypeptide receptor (GIPR) featuring monthly or less frequent dosing.
  • MARITIME-1, a Phase 3 study of MariTide for chronic weight management, is ongoing in adults living with obesity or overweight, without Type 2 diabetes (T2D).
  • MARITIME-2, a Phase 3 study of MariTide for chronic weight management, is ongoing in adults living with obesity or overweight, with T2D.
  • MARITIME-CV, a Phase 3 study of MariTide on cardiovascular (CV) outcomes, is enrolling adults living with established atherosclerotic cardiovascular disease and obesity or overweight.
  • MARITIME-HF, a Phase 3 study of MariTide on reduction of heart failure events and cardiovascular risk, is enrolling adults living with heart failure with preserved or mildly reduced ejection fraction and obesity.
  • MARITIME-OSA-1, a Phase 3 study of MariTide, is enrolling adults living with obstructive sleep apnea on positive airway pressure therapy and living with obesity or overweight.
  • MARITIME-OSA-2, a Phase 3 study of MariTide, is enrolling adults living with obstructive sleep apnea not on positive airway pressure therapy and living with obesity or overweight.
  • MARITIME-SWITCH, a Phase 3 study of MariTide, was initiated in adults living with obesity or overweight who will be switching from weekly tirzepatide or weekly semaglutide to MariTide on an every eight-week or quarterly dosing schedule.
  • MARITIME-1 EXTENSION, a Phase 3 long-term extension study of MariTide, was initiated to evaluate the maintenance of weight loss with monthly, every eight-week or quarterly dosing in adults living with obesity or overweight without T2D who completed the MARITIME-1 study.
  • MARITIME-2 EXTENSION, a Phase 3 long-term extension study of MariTide, was initiated to evaluate the maintenance of weight loss with monthly and every eight-week dosing in adults living with obesity or overweight with T2D who completed the MARITIME-2 study.
  • Three Phase 3 studies of MariTide in people living with T2D will be initiated in 2026.
  • A Phase 2b study of MariTide to assess the effect of MariTide on liver fat reduction and weight loss was initiated and is enrolling adults living with obesity or overweight with elevated liver fat.

AMG 513

  • A Phase 1 study of AMG 513 is enrolling adults living with obesity.

Repatha

  • In March, results from a new subgroup analysis of the Phase 3 VESALIUS-CV clinical trial were presented at the American College of Cardiology Annual Scientific Session and simultaneously published in the Journal of the American Medical Association . In this subset of 3,655 high-risk patients with diabetes without known significant atherosclerosis, Repatha:
  • demonstrated a 31% relative reduction in the risk of a composite of coronary heart disease death, heart attack or ischemic stroke (3-P MACE).
  • demonstrated a 31% reduction in a broader composite that also included ischemia-driven revascularization (4-P MACE).
  • reduced the risk of heart attack also by 31%.
  • was associated with a nominal 32% decreased risk of cardiovascular death and a 24% decreased risk of all-cause death.
  • Further subgroup analysis from VESALIUS-CV in patients who had a prior percutaneous coronary intervention will be presented at the upcoming European Course on Percutaneous Cardiovascular Interventions in May.
  • Further subgroup analysis from VESALIUS-CV in patients with high-risk of diabetes with and without known atherosclerosis will be presented at the upcoming American Diabetes Association Scientific Sessions in June.
  • EVOLVE-MI, a Phase 4 study of Repatha initiated within 10 days of an acute myocardial infarction to reduce the risk of cardiovascular events, is ongoing.

Olpasiran (AMG 890)

  • Olpasiran is a potentially best-in-class small interfering ribonucleic acid (siRNA) molecule that reduces lipoprotein(a) (Lp(a)) synthesis in the liver.
  • The OCEAN(a)-Outcomes trial, a Phase 3 secondary prevention CV outcomes study, is ongoing in patients with established atherosclerotic CV disease and elevated Lp(a).
  • The OCEAN(a)-PreEvent trial, a Phase 3 primary prevention CV outcomes study, is enrolling patients with elevated Lp(a) at high risk for a first major CV event.
  • The OCEAN(a)-Coronary Computed Tomography Angiography (CCTA), a Phase 3 coronary artery plaque study, was initiated and is enrolling patients with atherosclerotic CV disease and elevated Lp(a).

Rare Disease

UPLIZNA

  • In February, the European Commission approved UPLIZNA as an add-on to standard therapy for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) or anti-muscle specific tyrosine kinase (MuSK) antibody positive.
  • Phase 3 studies of UPLIZNA in patients with autoimmune hepatitis and in patients with chronic inflammatory demyelinating polyneuropathy will be initiated H2 2026.

TEPEZZA

  • In April, the Company announced positive topline results from a Phase 3 trial of TEPEZZA administered by subcutaneous injection via an on-body injector (OBI) in adults with moderate-to-severe active Thyroid Eye Disease (TED). In this study, TEPEZZA OBI:
  • showed comparable efficacy to intravenous (IV) TEPEZZA.
  • achieved the primary endpoint with a 77% proptosis response rate at week 24 compared to 19.6% for placebo (p<0.0001).
  • demonstrated a clinically meaningful mean reduction in proptosis of -3.17 mm at week 24 compared to -0.80 mm for placebo (p<0.0001).
  • showed statistically significant and clinically meaningful improvements across the following additional secondary endpoints: overall responder rate; percentage of patients achieving a Clinical Activity Score (CAS) of 0 or 1; change in diplopia as ordinal response categories; diplopia response rate; complete diplopia responder rate; and mean change from baseline in week 24 in the Graves' Ophthalmopathy Quality of Life (GO-QoL) appearance subscale.
  • demonstrated overall safety results that were generally consistent with the known safety profile of TEPEZZA IV. Mild-to-moderate injection site reactions were observed with subcutaneous administration in some patients, which did not result in treatment interruption or discontinuation. The most common adverse events (≥10%) were muscle spasms, tinnitus, weight decrease, ear discomfort, nausea and diarrhea. Full results from the study will be presented at an upcoming medical congress.
  • A separate Phase 3b/4 trial, conducted to fulfill a U.S. Food and Drug Administration (FDA) postmarketing requirement for TEPEZZA IV, has been completed. The primary objective of the study was to evaluate the safety and tolerability of three treatment durations (four, eight and 16 infusions) of TEPEZZA IV given once every 3 weeks in adult TED patients and assess the need for retreatment. The study was descriptive in nature. The observed risk profile was consistent with the known profile of TEPEZZA IV. The postmarketing data will be submitted to regulatory authorities and presented at an upcoming medical congress.

TAVNEOS

  • TAVNEOS (avacopan), a product the Company acquired in connection with its acquisition of ChemoCentryx, Inc in 2022, was approved by the FDA in October 2021 . TAVNEOS is indicated for the adjunctive treatment of adult patients with severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (AAV) in combination with standard therapy including glucocorticoids.
  • On April 27, 2026 , FDA's Center for Drug Evaluation and Research (CDER) issued a proposal to withdraw approval of TAVNEOS, asserting that there is new information indicating lack of substantial evidence of effectiveness for the drug and that ChemoCentryx's application that resulted in FDA approval contained untrue statements of material facts.
  • On April 30, 2026 , the FDA posted a notice in the Federal Register that proposes to withdraw approval of TAVNEOS and announced an opportunity for ChemoCentryx , as the U.S. marketing authorization holder, to request a hearing on this proposal.
  • As such, ChemoCentryx may request a hearing on this proposal, after which the FDA will determine whether there is a genuine and substantial issue of fact that requires a hearing. If a hearing is not granted, the FDA may enter summary judgment and ultimately withdraw approval.
  • The Company intends to engage with the FDA, continues to believe that TAVNEOS demonstrates effectiveness and a favorable benefit–risk profile, and intends to follow the appropriate process to support its position. As the FDA's statement reporting its proposal indicates, TAVNEOS will remain on the market during the pendency of this process.
  • Hepatotoxicity is a known risk of TAVNEOS treatment for AAV and has been a subject of ongoing dialogue with the FDA. In 2024, the Company provided an analysis of serious post-marketing cases of hepatotoxicity to the FDA. On March 31, 2026 , the FDA issued a Drug Safety Communication notifying patients and health care professionals about serious postmarketing cases including fatal cases of drug induced liver injury associated with TAVNEOS.
  • The current U.S. label includes a warning about hepatotoxicity and guidance for monitoring patients. The Drug Safety Communication provides additional information about drug-induced liver injury and vanishing bile duct syndrome (VBDS) associated with TAVNEOS.
  • Since approval in 2021, cases of VBDS have been reported, largely from Japan and none from the United States . Most patients who had VBDS were aged 65 years and older, and most cases occurred within 90 days of starting TAVNEOS. VBDS has been fatal in some of these patients. The Company remains committed to keeping patient safety, needs, and support at the forefront.
  • On April 29, 2026 , the Company submitted a Changes Being Effected (CBE-30) supplement to the FDA. The CBE-30 filing amends the hepatotoxicity warning language in the label to provide more information on cases of VBDS that have been observed in the post-marketing setting, including that cases with fatal outcomes have been reported, and modifies language regarding liver panel testing and treatment discontinuation rules.
  • A Phase 3, open-label study of TAVNEOS in combination with rituximab or a cyclophosphamide-containing regimen is enrolling patients from 6 years to < 18 years of age with active ANCA-associated vasculitis (Granulomatosis with Polyangiitis (GPA)/Microscopic Polyangiitis (MPA)).

Dazodalibep

  • Dazodalibep is a fusion protein that inhibits CD40L.
  • Two Phase 3 studies of dazodalibep in Sjögren's disease are underway. The first study is ongoing in patients with moderate-to-severe systemic disease activity. The second study is ongoing in patients with moderate to high symptom burden with low systemic disease activity. Completion of both studies is expected in H2 2026.

Daxdilimab

  • Daxdilimab is a first-in-class plasmacytoid dendritic cell (pDC) depleting monoclonal antibody targeting immunoglobulin-like transcript 7 (ILT7).
  • The Company is taking steps to advance daxdilimab to a registrational phase of development.

AMG 329

  • AMG 329 is a fully human monoclonal antibody targeting FMS-like tyrosine kinase 3 (FLT3) ligand.
  • A Phase 2 study of AMG 329 in patients with Sjögren's disease met pre-defined criteria for futility and was stopped.

AMG 732

  • AMG 732 is an insulin-like growth factor-1 receptor (IGF-1R) targeting monoclonal antibody.
  • A Phase 2 study of AMG 732 is enrolling patients with moderate-to-severe active TED.

Inflammation

TEZSPIRE

  • Two Phase 3 studies of TEZSPIRE are enrolling adults with moderate to very severe chronic obstructive pulmonary disease (COPD) and a BEC ≥ 150 cells/µl.
  • A Phase 3 study of TEZSPIRE is ongoing in patients with eosinophilic esophagitis. Study completion is expected in H2 2026.

Blinatumomab

  • Blinatumomab is a bispecific T-cell engager (BiTE ® ) molecule targeting CD19.
  • A Phase 2 study of blinatumomab in autoimmune disease is enrolling adults with refractory rheumatoid arthritis.
  • A Phase 2 study of blinatumomab in adults with systemic lupus erythematosus (SLE), with and without nephritis, has stopped enrollment. The Company is determining next steps in this setting.

Inebilizumab

  • Inebilizumab is a B-cell depleting monoclonal antibody targeting CD19.
  • A Phase 2 study of inebilizumab in autoimmune disease is enrolling adults with SLE with nephritis.

AMG 104 (AZD8630)

  • AMG 104 is an inhaled anti-thymic stromal lymphopoietin (TSLP) fragment antigen-binding (Fab) protein.
  • A Phase 2 study is ongoing in patients with asthma. Study completion is expected in H1 2026.

Oncology

BLINCYTO / blinatumomab

  • Golden Gate, a Phase 3 study of BLINCYTO alternating with low-intensity chemotherapy, is enrolling older adult patients with newly diagnosed CD19-positive Ph-negative B-cell precursor acute lymphoblastic leukemia (B-ALL).
  • A potentially registration-enabling Phase 2 study of subcutaneous blinatumomab has paused enrollment of both adults and adolescents with relapsed or refractory CD19-positive Philadelphia chromosome (Ph) negative B-ALL.
  • A Phase 1b/2 study of subcutaneous blinatumomab has paused enrollment of pediatric patients with relapsed / refractory and minimal residual disease positive (MRD+) B-ALL.

IMDELLTRA / tarlatamab

  • IMDELLTRA is the first and only FDA-approved delta-like ligand 3 (DLL3) targeting BiTE molecule.
  • In April, China National Medical Products Administration (NMPA) granted a conditional approval to IMDELLTRA for the treatment of third-line extensive stage small cell lung cancer (SCLC).
  • The Company is advancing a comprehensive, global clinical development program across extensive-stage (ES) and limited-stage (LS) SCLC:
  • DeLLphi-303, a Phase 1b study of IMDELLTRA in combination with a programmed cell death protein ligand-1 (PD-L1) inhibitor, carboplatin and etoposide or separately in combination with a PD-L1 inhibitor alone, is ongoing in patients with first-line ES-SCLC.
  • DeLLphi-305, a Phase 3 study of IMDELLTRA and durvalumab is ongoing in first-line ES-SCLC in the maintenance setting.
  • DeLLphi-306, a Phase 3 study of IMDELLTRA following concurrent chemoradiation therapy, has completed enrollment of patients with LS-SCLC.
  • DeLLphi-308, a Phase 1b study evaluating subcutaneous tarlatamab, is enrolling patients with second line or later ES-SCLC.
  • DeLLphi-309, a Phase 2 study evaluating alternative intravenous dosing regimens of IMDELLTRA in second-line ES-SCLC has completed enrollment.
  • DeLLphi-310, a Phase 1b study of IMDELLTRA in combination with YL201, a B7-H3 targeting antibody-drug conjugate, with or without a PD-L1 inhibitor, has paused enrollment of patients with ES-SCLC.
  • DeLLphi-311, a Phase 1b study of IMDELLTRA in combination with etakafusp alfa (AB248), a novel CD8+ T-cell selective interleukin-2 (IL-2), is enrolling patients with second-line or later ES-SCLC.
  • DeLLphi-312, a Phase 3 study of IMDELLTRA in combination with carboplatin, etoposide and durvalumab, is enrolling patients with first-line ES-SCLC.
  • DeLLphi-313, a Phase 1b study of IMDELLTRA in combination with zocilurtatug pelitecan, a DLL3 targeting antibody drug conjugate, with and without a PD-L1 inhibitor was initiated and is enrolling patients with ES-SCLC.

Xaluritamig (AMG 509)

  • Xaluritamig is a first-in-class bispecific T-cell engager targeting six-transmembrane epithelial antigen of prostate 1 (STEAP1).
  • XALute, a Phase 3 study of xaluritamig, is enrolling patients with metastatic castration-resistant prostate cancer (mCRPC) who have previously been treated with taxane-based chemotherapy.
  • XALience, a Phase 3 study of xaluritamig in combination with abiraterone is enrolling patients with chemotherapy-naïve mCRPC.
  • A Phase 1 study of xaluritamig monotherapy and xaluritamig in combination with abiraterone is ongoing in patients with mCRPC who have not yet received taxane-based chemotherapy. This study is also ongoing in patients with mCRPC who have previously received taxane-based chemotherapy in a fully outpatient treatment setting to further improve administration convenience.
  • A Phase 1b study of neoadjuvant xaluritamig therapy prior to radical prostatectomy is enrolling patients with newly diagnosed localized intermediate or high‐risk prostate cancer.
  • A Phase 1b study of xaluritamig is ongoing with high-risk biochemically recurrent prostate cancer after definitive therapy.
  • A Phase 1b study of xaluritamig in combination with androgen receptor pathway inhibitors is enrolling patients with metastatic hormone-sensitive prostate cancer.
  • A Phase 1b study of xaluritamig was initiated in adults with mCRPC to evaluate an additional dosing regimen.
  • A Phase 1b study of xaluritamig is enrolling adult, adolescent and pediatric patients with relapsed or refractory Ewing sarcoma.

AMG 193

  • AMG 193 is a first-in-class small molecule methylthioadenosine (MTA)-cooperative protein arginine methyltransferase 5 (PRMT5) inhibitor.
  • Following a comprehensive review of the oncology portfolio and emerging AMG 193 clinical data, the Company will discontinue further development of AMG 193.
  • As such, the following studies will be discontinued:
  • a Phase 2 study of AMG 193 in patients with methylthioadenosine phosphorylase (MTAP)-null previously treated advanced non-small cell lung cancer (NSCLC).
  • a Phase 1/1b/2 study of AMG 193 in patients with advanced MTAP-null solid tumors in the dose-expansion portion of the study.
  • a Phase 1b study of AMG 193 alone or in combination with other therapies in patients with advanced MTAP-null thoracic malignancies.
  • a Phase 1b study of AMG 193 in combination with other therapies in patients with advanced MTAP-null gastrointestinal, biliary tract or pancreatic cancers.

LUMAKRAS/LUMYKRAS

  • CodeBreaK 301, a Phase 3 study of LUMAKRAS in combination with Vectibix and FOLFIRI vs. FOLFIRI with or without bevacizumab-awwb, is enrolling patients with first-line KRAS G12C–mutated metastatic colorectal cancer.
  • CodeBreaK 202, a Phase 3 study of LUMAKRAS plus platinum doublet chemotherapy vs. pembrolizumab plus chemotherapy, is enrolling patients with first-line KRAS G12C–mutated and PD-L1 negative advanced NSCLC.

Nplate

  • PROCLAIM, a Phase 3 study of Nplate for the treatment of chemotherapy-induced thrombocytopenia, is ongoing in patients with NSCLC, ovarian cancer, or breast cancer.

Biosimilars

  • A randomized, double-blind comparative clinical study of ABP 206 compared with OPDIVO ® (nivolumab) is ongoing in patients with treatment-naïve unresectable or metastatic melanoma.
  • A randomized, double-blind pharmacokinetic similarity study of ABP 234 compared with KEYTRUDA ® (pembrolizumab) has completed enrollment of patients with early-stage non-squamous NSCLC as adjuvant treatment.
  • A randomized, double-blind combined pharmacokinetic/comparative clinical study of ABP 234 compared to KEYTRUDA ® is ongoing in patients with advanced or metastatic non-squamous NSCLC.
  • A randomized, double-blind, pharmacokinetic similarity/comparative clinical study of ABP 692 compared to OCREVUS ® (ocrelizumab) is enrolling patients with relapsing-remitting multiple sclerosis.

TEZSPIRE is being developed in collaboration with AstraZeneca.

AMG 104 is being developed in collaboration with AstraZeneca.

Xaluritamig, formerly AMG 509, is being developed pursuant to a research collaboration with Xencor, Inc.

YL201 is an investigational B7-H3 targeting antibody-drug conjugate being developed by MediLink.

Zocilurtatug pelitecan is an investigational DLL-3 targeting antibody-drug conjugate being developed by Zai Lab Limited.

Etakafusp alfa (AB248) is a novel CD8+ T cell selective interleukin-2 (IL-2) being developed by Asher Biotherapeutics.

OPDIVO is a registered trademark of Bristol-Myers Squibb Company.

KEYTRUDA is a registered trademark of Merck & Co., Inc.

OCREVUS is a registered trademark of Genentech, Inc.

Non-GAAP Financial Measures

In this news release, management has presented its operating results for the first quarters of 2026 and 2025, in accordance with U.S. Generally Accepted Accounting Principles (GAAP) and on a non-GAAP basis. In addition, management has presented its full year 2026 EPS and tax guidance in accordance with GAAP and on a non-GAAP basis. These non-GAAP financial measures are computed by excluding certain items related to acquisitions, restructuring and certain other items from the related GAAP financial measures. Management has presented Free Cash Flow (FCF), which is a non-GAAP financial measure, for the first quarters of 2026 and 2025. FCF is computed by subtracting capital expenditures from operating cash flow, each as determined in accordance with GAAP.

The Company believes that its presentation of non-GAAP financial measures provides useful supplementary information to and facilitates additional analysis by investors. The Company uses certain non-GAAP financial measures to enhance an investor's overall understanding of the financial performance and prospects for the future of the Company's normal and recurring business activities by facilitating comparisons of results of normal and recurring business operations among current, past and future periods. The Company believes that FCF provides a further measure of the Company's liquidity.

The Company uses the non-GAAP financial measures set forth in the news release in connection with its own budgeting and financial planning internally to evaluate the performance of the business, including to allocate resources and to evaluate results relative to incentive compensation targets. The non-GAAP financial measures are in addition to, not a substitute for, or superior to, measures of financial performance prepared in accordance with GAAP.

About Amgen

Amgen discovers, develops, manufactures and delivers innovative medicines to fight some of the world's toughest diseases. Harnessing the best of biology and technology, Amgen reaches millions of patients with its medicines.

More than 45 years ago, Amgen helped establish the biotechnology industry at its U.S. headquarters in Thousand Oaks, California , and it remains at the cutting edge of innovation, using technology and human genetic data to push beyond what is known today. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat cancer, inflammatory conditions, rare diseases, heart disease and obesity and obesity-related conditions.

Amgen has been consistently recognized for innovation and workplace culture, including honors from Fast Company and Forbes. Amgen is one of the 30 companies that comprise the Dow Jones Industrial Average ® , and it is also part of the Nasdaq-100 Index ® , which includes the largest and most innovative non-financial companies listed on the Nasdaq Stock Market based on market capitalization.

For more information, visit Amgen.com and follow Amgen on X , LinkedIn , Instagram , YouTube , Facebook , TikTok and Threads .

Forward-Looking Statements

This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including any statements on the outcome, benefits and synergies of collaborations, or potential collaborations, with any other company (including BeOne Medicines Ltd.), the performance of Otezla ® (apremilast), our acquisitions of ChemoCentryx, Inc. , Dark Blue Therapeutics, Ltd. or Horizon Therapeutics plc (including the prospective performance and outlook of Horizon's business, performance and opportunities, and any potential strategic benefits, synergies or opportunities expected as a result of such acquisition), as well as estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes, effects of pandemics or other widespread health problems on our business, outcomes, progress, and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission reports filed by Amgen , including our most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and current reports on Form 8-K. Unless otherwise noted, Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.

No forward-looking statement can be guaranteed and actual results may differ materially from those we project. Our results may be affected by our ability to successfully market both new and existing products domestically and internationally, clinical and regulatory developments involving current and future products, sales growth of recently launched products, competition from other products including biosimilars, difficulties or delays in manufacturing our products and global economic conditions, including those resulting from geopolitical relations and government actions. In addition, sales of our products are affected by pricing pressure, political and public scrutiny and reimbursement policies imposed by third-party payers, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment. Furthermore, our research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. We or others could identify safety, side effects or manufacturing problems with our products, including our devices, after they are on the market. Our business may be impacted by government investigations, litigation and product liability claims. In addition, our business may be impacted by the adoption of new tax legislation or exposure to additional tax liabilities. Further, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors, or we may fail to prevail in present and future intellectual property litigation. We perform a substantial amount of our commercial manufacturing activities at a few key facilities, including in Puerto Rico , and also depend on third parties for a portion of our manufacturing activities, and limits on supply may constrain sales of certain of our current products and product candidate development. An outbreak of disease or similar public health threat, and the public and governmental effort to mitigate against the spread of such disease, could have a significant adverse effect on the supply of materials for our manufacturing activities, the distribution of our products, the commercialization of our product candidates, and our clinical trial operations, and any such events may have a material adverse effect on our product development, product sales, business and results of operations. We rely on collaborations with third parties for the development of some of our product candidates and for the commercialization and sales of some of our commercial products. In addition, we compete with other companies with respect to many of our marketed products as well as for the discovery and development of new products. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, some raw materials, medical devices and component parts for our products are supplied by sole third-party suppliers. Certain of our distributors, customers and payers have substantial purchasing leverage in their dealings with us. The discovery of significant problems with a product similar to one of our products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on our business and results of operations. Our efforts to collaborate with or acquire other companies, products or technology, and to integrate the operations of companies or to support the products or technology we have acquired, may not be successful, and may result in unanticipated costs, delays or failures to realize the benefits of the transactions. A breakdown, cyberattack or information security breach of our information technology systems could compromise the confidentiality, integrity and availability of our systems and our data. Our stock price is volatile and may be affected by a number of events. Our business and operations may be negatively affected by the failure, or perceived failure, of achieving our sustainability objectives. The effects of global climate change and related natural disasters could negatively affect our business and operations. Global economic conditions may magnify certain risks that affect our business. Our business performance could affect or limit the ability of our Board of Directors to declare a dividend or our ability to pay a dividend or repurchase our common stock. We may not be able to access the capital and credit markets on terms that are favorable to us, or at all.

CONTACT: Amgen , Thousand Oaks

Elissa Snook , 609-251-1407 (media)

Annik Allen , 917-288-9136 (media)

Casey Capparelli , 805-447-1746 (investors)

Amgen Inc.

Consolidated Statements of Income - GAAP

(In millions, except per-share data)

(Unaudited)

Three months ended

March 31 ,

2026

2025

Revenues:

Product sales

$ 8,218

$ 7,873

Other revenues

400

276

Total revenues

8,618

8,149

Operating expenses:

Cost of sales

2,744

2,968

Research and development

1,719

1,486

Selling, general and administrative

1,602

1,687

Other

(113)

830

Total operating expenses

5,952

6,971

Operating income

2,666

1,178

Other income (expense):

Interest expense, net

(657)

(723)

Other income, net

75

1,518

Income before income taxes

2,084

1,973

Provision for income taxes

265

243

Net income

$ 1,819

$ 1,730

Earnings per share:

Basic

$ 3.37

$ 3.22

Diluted

$ 3.34

$ 3.20

Weighted-average shares used in calculation of earnings per share:

Basic

540

538

Diluted

544

541

Amgen Inc.

Consolidated Balance Sheets - GAAP

(In millions)

March 31 ,

December 31 ,

2026

2025

(Unaudited)

Assets

Current assets:

Cash and cash equivalents

$ 12,038

$ 9,129

Trade receivables, net

9,138

9,570

Inventories

6,186

6,225

Other current assets

4,113

4,133

Total current assets

31,475

29,057

Property, plant and equipment, net

8,216

7,913

Intangible assets, net

21,379

22,276

Goodwill

18,674

18,680

Other noncurrent assets

12,760

12,660

Total assets

$ 92,504

$ 90,586

Liabilities and Stockholders' Equity

Current liabilities:

Accounts payable and accrued liabilities

$ 19,518

$ 20,890

Current portion of long-term debt

5,437

4,599

Total current liabilities

24,955

25,489

Long-term debt

51,886

50,005

Long-term deferred tax liabilities

1,344

1,366

Long-term tax liabilities

2,764

2,690

Other noncurrent liabilities

2,365

2,378

Total stockholders' equity

9,190

8,658

Total liabilities and stockholders' equity

$ 92,504

$ 90,586

Shares outstanding

540

539

Amgen Inc.

GAAP to Non-GAAP Reconciliations

(Dollars in millions)

(Unaudited)

Three months ended

March 31 ,

2026

2025

GAAP cost of sales

$ 2,744

$ 2,968

Adjustments to cost of sales:

Acquisition-related expenses (a)

(1,141)

(1,548)

Non-GAAP cost of sales

$ 1,603

$ 1,420

GAAP cost of sales as a percentage of product sales

33.4 %

37.7 %

Acquisition-related expenses (a)

(13.9)

(19.7)

Non-GAAP cost of sales as a percentage of product sales

19.5 %

18.0 %

GAAP research and development expenses

$ 1,719

$ 1,486

Adjustments to research and development expenses:

Acquisition-related expenses (b)

(8)

(11)

Non-GAAP research and development expenses

$ 1,711

$ 1,475

GAAP research and development expenses as a percentage of product sales

20.9 %

18.9 %

Acquisition-related expenses (b)

(0.1)

(0.2)

Non-GAAP research and development expenses as a percentage of product sales

20.8 %

18.7 %

GAAP selling, general and administrative expenses

$ 1,602

$ 1,687

Adjustments to selling, general and administrative expenses:

Acquisition-related expenses (c)

(6)

(32)

Certain net charges pursuant to our restructuring and cost-savings initiatives

(13)

Total adjustments to selling, general and administrative expenses

(19)

(32)

Non-GAAP selling, general and administrative expenses

$ 1,583

$ 1,655

GAAP selling, general and administrative expenses as a percentage of product sales

19.5 %

21.4 %

Acquisition-related expenses (c)

(0.1)

(0.4)

Certain net charges pursuant to our restructuring and cost-savings initiatives

(0.1)

0.0

Non-GAAP selling, general and administrative expenses as a percentage of product sales

19.3 %

21.0 %

GAAP operating expenses

$ 5,952

$ 6,971

Adjustments to operating expenses:

Adjustments to cost of sales

(1,141)

(1,548)

Adjustments to research and development expenses

(8)

(11)

Adjustments to selling, general and administrative expenses

(19)

(32)

Impairment of intangible assets (d)

(800)

Certain net charges pursuant to our restructuring and cost-savings initiatives

(20)

1

Certain other expenses (e)

133

(31)

Total adjustments to operating expenses

(1,055)

(2,421)

Non-GAAP operating expenses

$ 4,897

$ 4,550

Three months ended

March 31 ,

2026

2025

GAAP operating income

$ 2,666

$ 1,178

Adjustments to operating expenses

1,055

2,421

Non-GAAP operating income

$ 3,721

$ 3,599

GAAP operating income as a percentage of product sales

32.4 %

15.0 %

Adjustments to cost of sales

13.9

19.7

Adjustments to research and development expenses

0.1

0.2

Adjustments to selling, general and administrative expenses

0.1

0.4

Impairment of intangible assets (d)

0.0

10.1

Certain net charges pursuant to our restructuring and cost-savings initiatives

0.3

0.0

Certain other expenses (e)

(1.5)

0.3

Non-GAAP operating income as a percentage of product sales

45.3 %

45.7 %

GAAP other income, net

$ 75

$ 1,518

Adjustments to other income, net:

Net losses (gains) from equity investments (f)

102

(1,291)

Non-GAAP other income, net

$ 177

$ 227

GAAP income before income taxes

$ 2,084

$ 1,973

Adjustments to income before income taxes:

Adjustments to operating expenses

1,055

2,421

Adjustments to other income, net

102

(1,291)

Total adjustments to income before income taxes

1,157

1,130

Non-GAAP income before income taxes

$ 3,241

$ 3,103

GAAP provision for income taxes

$ 265

$ 243

Adjustments to provision for income taxes:

Income tax effect of the above adjustments (g)

176

217

Other income tax adjustments (h)

1

(6)

Total adjustments to provision for income taxes

177

211

Non-GAAP provision for income taxes

$ 442

$ 454

GAAP tax as a percentage of income before taxes

12.7 %

12.3 %

Adjustments to provision for income taxes:

Income tax effect of the above adjustments (g)

0.9

2.5

Other income tax adjustments (h)

0.0

(0.2)

Total adjustments to provision for income taxes

0.9

2.3

Non-GAAP tax as a percentage of income before taxes

13.6 %

14.6 %

GAAP net income

$ 1,819

$ 1,730

Adjustments to net income:

Adjustments to income before income taxes, net of the income tax effect

981

913

Other income tax adjustments (h)

(1)

6

Total adjustments to net income

980

919

Non-GAAP net income

$ 2,799

$ 2,649

Note: Numbers may not add due to rounding

Amgen Inc.

GAAP to Non-GAAP Reconciliations

(In millions, except per-share data)

(Unaudited)

The following table presents the computations for GAAP and non-GAAP diluted earnings per share:

Three months ended

March 31, 2026

Three months ended

March 31, 2025

GAAP

Non-GAAP

GAAP

Non-GAAP

Net income

$ 1,819

$ 2,799

$ 1,730

$ 2,649

Shares (Denominator):

Weighted-average shares for diluted EPS

544

544

541

541

Diluted EPS

$ 3.34

$ 5.15

$ 3.20

$ 4.90

(a)

The adjustments related primarily to noncash amortization of intangible assets and fair value step-up of inventory acquired from business combinations.

(b)

For the three months ended March 31, 2026 and 2025, the adjustments related primarily to noncash amortization of intangible assets acquired from business combinations.

(c)

For the three months ended March 31, 2026 and 2025, the adjustments related primarily to acquisition-related costs related to our Horizon acquisition.

(d)

For the three months ended March 31, 2025 , the adjustment related to an intangible asset impairment charge for Otezla ® .

(e)

For the three months ended March 31, 2026 , the adjustment included litigation settlements.

(f)

For the three months ended March 31, 2026 and 2025, the adjustments related primarily to our BeOne Medicines Ltd. equity fair value adjustment.

(g)

The tax effect of the adjustments between our GAAP and non-GAAP results takes into account the tax treatment and related tax rate(s) that apply to each adjustment in the applicable tax jurisdiction(s). Generally, the tax impact of adjustments, including the amortization and impairments of intangible assets and acquired inventory, gains and losses on our investments in equity securities and expenses related to restructuring and cost-savings initiatives, depends on whether the amounts are deductible in the respective tax jurisdictions and the applicable tax rate(s) in those jurisdictions. Due to these factors, the effective tax rate for the adjustments to our GAAP income before income taxes for the three months ended March 31, 2026 , was 15.2% compared to 19.2% for the corresponding period of the prior year.

(h)

The adjustments related to certain acquisition-related, prior-period and other items excluded from GAAP earnings.

Amgen Inc.

Reconciliations of Cash Flows

(In millions)

(Unaudited)

Three months ended

March 31 ,

2026

2025

Net cash provided by operating activities

$ 2,189

$ 1,391

Net cash used in investing activities

(716)

(447)

Net cash provided by (used in) financing activities

1,436

(4,107)

Increase (decrease) in cash and cash equivalents

2,909

(3,163)

Cash and cash equivalents at beginning of period

9,129

11,973

Cash and cash equivalents at end of period

$ 12,038

$ 8,810

Three months ended

March 31 ,

2026

2025

Net cash provided by operating activities

$ 2,189

$ 1,391

Capital expenditures

(712)

(411)

Free cash flow

$ 1,477

$ 980

Amgen Inc.

Reconciliation of GAAP EPS Guidance to Non-GAAP

EPS Guidance for the Year Ending December 31, 2026

(Unaudited)

GAAP diluted EPS guidance

$ 15.62

$ 17.10

Known adjustments to arrive at non-GAAP*:

Acquisition-related expenses (a)

6.02

6.10

Net losses from equity investments

0.15

Other

(0.17)

Non-GAAP diluted EPS guidance

$ 21.70

$ 23.10

*

The known adjustments are presented net of their related tax impact, which amount to approximately $1.09 per share.

(a)

The adjustment primarily includes noncash amortization of intangible assets and fair value step-up of inventory acquired in business combinations.

Our GAAP diluted EPS guidance does not include the effect of GAAP adjustments triggered by events that may occur subsequent to this press release such as acquisitions, asset impairments, litigation, changes in fair value of our contingent consideration obligations and changes in fair value of our equity investments.

Reconciliation of GAAP Tax Rate Guidance to Non-GAAP

Tax Rate Guidance for the Year Ending December 31, 2026

(Unaudited)

GAAP tax rate guidance

14.5 %

16.0 %

Tax rate of known adjustments discussed above

0.5 %

Non-GAAP tax rate guidance

15.0 %

16.5 %

View original content to download multimedia: https://www.prnewswire.com/news-releases/amgen-reports-first-quarter-2026-financial-results-302759393.html

SOURCE Amgen

打开原文

莫德纳收入回升与现金消耗

重要性3/5 中

MRNA 一手财报直接涉及收入、现金消耗、和解付款与关键监管节点,但发布时间早于当前日报,前瞻性目标需后续事件验证。

中文摘要

核心结论

莫德纳(Moderna,股票代码 MRNA)2026 年第一季度收入升至 3.89 亿美元,国际市场贡献约 80%,但仍录得 13.43 亿美元净亏损,其中 9 亿美元为诉讼和解相关的非经常性费用。公司维持 2026 年收入最多增长 10% 及费用下降目标,现金与投资余额由年末 81 亿美元降至 75 亿美元,商业化进展和后期临床读出将共同决定该目标的可验证性。

重要性评级

评级:3/5(中)

这是 MRNA 的官方一季报及向美国证券交易委员会提交的材料,直接披露收入来源、亏损、现金和关键临床节点;发布于 05/01,当前更适合作为公司档案与后续事件的基准。

关键事实

  • 2026 年第一季度总收入为 3.89 亿美元,较上年同期增加 2.81 亿美元;美国收入 7800 万美元,国际收入 3.11 亿美元,国际市场约占收入 80%。公司称增长主要来自政府长期战略合作下的国际新冠疫苗交付。
  • 第一季度净亏损为 13.43 亿美元,每股亏损 3.40 美元;诉讼和解相关费用使净亏损增加约 9 亿美元、每股亏损增加 2.22 美元。
  • 销售成本为 9.55 亿美元,其中第三方特许权使用费 8.95 亿美元,包含 8.78 亿美元诉讼和解相关费用;研发费用同比下降 24% 至 6.49 亿美元,销售、一般及管理费用同比下降 18% 至 1.73 亿美元。
  • 截至 03/31,现金、现金等价物和投资合计为 75 亿美元,低于 12/31 的 81 亿美元;公司预计 9.5 亿美元和解付款将在第三季度支付。
  • 公司目标是 2026 年收入较 2025 年最多增长 10%,预计全年销售成本约 18 亿美元、研发约 30 亿美元、销售及管理约 10 亿美元,年末现金和投资预计为 45 亿至 50 亿美元,未计入剩余 9 亿美元信贷额度可能的提款。
  • 欧洲委员会已批准 mNEXSPIKE(新冠疫苗)和 mCOMBRIAX(流感与新冠联合疫苗);mRNA-1010(季节性流感疫苗)的美国处方药使用者付费法案审评目标日为 08/05(未给出具体时刻)。
  • 肿瘤候选疗法 intismeran autogene(个体化癌症疫苗)与默克合作,已有 9 项二期和三期试验;高风险一期非小细胞肺癌单药及联用 KEYTRUDA QLEX 的三期试验已启动。公告称其黑色素瘤辅助治疗二期 b 期五年数据中,相对单用 KEYTRUDA 的复发或死亡风险降低 49%。

作者观点与证据

管理层将收入增长、欧洲批准和成本压缩描述为 2026 年恢复销售增长的开端。财务数字、监管状态与试验启动来自公司披露;收入增长目标、年末现金预测、审批预期和潜在数据读出均属前瞻性陈述,受病例累积、监管决定、研发结果及付款时点影响。

与相关标的的关系

MRNA 的近期收入仍主要受国际新冠疫苗合同交付影响,收入地域结构与季节性疫苗审批进展直接关联。现金余额、第三季度 9.5 亿美元和解付款及后期项目读出共同影响其研发持续性;公告未提供产品级毛利、订单可见度或独立销售预测。

时效性与限制

文件发布于 05/01(未给出具体时刻),来源为莫德纳及美国证券交易委员会披露;截至 07/11,部分监管节点和临床计划可能已有新信息。原文提取供受保护的内部报告阅读,疗效数字来自公司描述的单项研究更新,不能替代完整试验资料和监管审评结果。

后续跟踪

  • 08/05(未给出具体时刻)美国流感疫苗审评目标及流感新冠联合疫苗的重新申报进展。
  • 第三季度 9.5 亿美元和解付款对现金余额和全年现金预测的影响。
  • 诺如病毒、黑色素瘤和丙酸血症项目在 2026 年的读出时间与结果。
  • 国际疫苗合同交付、美国与国际收入占比及费用压缩执行情况。
原文
Moderna Reports First Quarter 2026 Financial Results and Provides Business Updates

Exhibit 99.1

Moderna Reports First Quarter 2026 Financial Results and Provides Business Updates

Reports first quarter revenue of $0.4 billion, with approximately 80% of revenue from international markets

Reports first quarter GAAP net loss of $(1.3) billion and GAAP EPS of $(3.40), including $0.9 billion non-recurring litigation settlement charge

Reiterates plan to deliver up to 10% revenue growth and GAAP operating expense reductions in 2026, excluding the non-recurring litigation settlement charge

Advanced infectious disease portfolio with key regulatory milestones in the EU, including approval of mNEXSPIKE and mCOMBRIAX, Moderna’s flu plus COVID combination vaccine

Initiated Phase 3 clinical study evaluating intismeran autogene as monotherapy and in combination with KEYTRUDA QLEX for treatment of high-risk Stage 1 non-small cell lung cancer

CAMBRIDGE, MA / ACCESSWIRE / May 1, 2026 / Moderna, Inc. (NASDAQ:MRNA) today reported financial results and provided business updates for the first quarter of 2026.

“The Moderna team delivered a great start to the year, driving significant revenue growth and substantial cost reductions building on actions taken in 2025. We received two product approvals in Europe, including the world’s first flu plus COVID combination vaccine, mCOMBRIAX. We also started a new pivotal trial for intismeran—our first Phase 3 monotherapy study for high-risk Stage 1 non-small cell lung cancer patients,” said Stéphane Bancel, Chief Executive Officer of Moderna. “Building on this strong first quarter momentum, we are excited to return to sales growth in 2026 and expect several additional approvals around the world, including for our seasonal flu vaccine, which would be Moderna’s fifth approved product. We also look forward to important pivotal readouts this year for our norovirus, intismeran in melanoma, and propionic acidemia programs."

Commercial Updates

During the first quarter, Moderna continued to advance its multi-year revenue growth strategy by executing on strategic partnerships and key approvals. In the UK, t he Company delivered the first shipment under its long-term strategic partnership. Moderna also received regulatory approval in Europe for mNEXSPIKE® and its flu plus COVID combination vaccine, mCOMBRIAX®, as well as mRESVIA® for all individuals aged 18 and older.

First Quarter 2026 Financial Results

Revenue : Total revenue for the first quarter of 2026 was $389 million, an increase of $281 million compared to the same period in 2025. Revenue was $78 million in the U.S. and $311 million in international markets. Net product sales increased due to higher COVID vaccine sales, primarily in international markets, as a result of deliveries under long-term strategic partnerships with government entities.

1

Cost of Sales: Cost of sales for the first quarter of 2026 was $955 million, including third-party royalties of $895 million and inventory write-downs of $38 million. Cost of sales increased by $865 million, compared to the same period in 2025, primarily driven by litigation settlement-related expenses of $878 million recognized in the first quarter of 2026 within third-party royalties. Excluding these expenses, cost of sales decreased compared to the same period in 2025, primarily due to lower unutilized manufacturing capacity costs, losses on firm purchase commitments and inventory write-downs, partially offset by higher sales volume.

Research and Development Expenses: Research and development expenses for the first quarter of 2026 were $649 million, a 24% decrease compared to the same period in 2025. The decrease was primarily driven by lower clinical development and manufacturing costs, reflecting the wind-down of large Phase 3 respiratory programs and congenital CMV studies, as well as the timing of clinical trial activities, partially offset by higher costs related to postmarketing commitments for the Company's COVID products.

Selling, General and Administrative Expenses: Selling, general and administrative expenses for the first quarter of 2026 were $173 million, an 18% decrease compared to the same period in 2025. The decrease was primarily driven by lower employee-related expenses, as well as reduced marketing costs and lower consulting and external services across multiple functions, reflecting continued discipline across the organization.

Income Taxes: Income tax provisions for both periods were not material, as the Company continues to maintain a global valuation allowance against most of its deferred tax assets.

Net Loss: Net loss was $(1.3) billion for the first quarter of 2026, compared to net loss of $(1.0) billion for the first quarter of 2025. Litigation settlement-related expenses had an unfavorable impact of $(0.9) billion on net loss for the first quarter of 2026.

Loss Per Share: Loss per share was $(3.40) for the first quarter of 2026, compared to loss per share of $(2.52) for the first quarter of 2025. Litigation settlement-related expenses had an unfavorable impact of $(2.22) on loss per share for the first quarter of 2026.

Cash Position: Cash, cash equivalents and investments as of March 31, 2026, were $7.5 billion, compared to $8.1 billion as of December 31, 2025. The decrease was primarily driven by operating losses associated with continued investment in research and development and advancement of the Company’s pipeline. Litigation settlement-related expenses recognized in the first quarter of 2026 did not impact cash during the period, as the related payment of $950 million is expected to be made in the third quarter of 2026.

2026 Financial Framework

Revenue: The Company is targeting up to 10% growth from 2025 revenue and expects 2026 revenue split to be approximately 50% U.S. and approximately 50% international.

Cost of Sales: Cost of sales for 2026 is now expected to be approximately $1.8 billion, including the $0.9 billion non-recurring litigation settlement charge.

2

Research and Development Expenses: Research and development expenses for 2026 are anticipated to be approximately $3.0 billion.

Selling, General and Administrative Expenses: Selling, general and administrative expenses for 2026 are projected to be approximately $1.0 billion.

Income Taxes: The Company expects its full-year tax expense to be negligible.

Capital Expenditures: Capital expenditures for 2026 are expected to be $0.2 to $0.3 billion.

Cash and Investments: Year-end cash and investments for 2026 are now projected to be $4.5 to $5.0 billion, which excludes any further drawdowns from the Company's remaining $0.9 billion available under its credit facility.

Recent Progress and Upcoming Late-Stage Pipeline Milestones

Infectious disease vaccines:

• Seasonal flu + COVID vaccine : Moderna recently presented mRNA-1083 data from a Japanese cohort at the 2026 European Society of Clinical Microbiology and Infectious Diseases (ESCMID) Global Congress. The Company has received European Commission marketing authorization for mCOMBRIAX in the EU and its mRNA-1083 regulatory filings are under review in Canada and Australia. Moderna is awaiting further guidance from the U.S. FDA on refiling the submission for its flu plus COVID combination vaccine.

• Seasonal flu vaccine : Moderna recently presented mRNA-1010 revaccination data at the 2026 ESCMID Global Congress. The Company's mRNA-1010 regulatory filings are under review in Europe, Canada and Australia and potential approvals are expected to begin in 2026. The U.S. FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date for mRNA-1010 of August 5, 2026.

• Norovirus vaccine : Moderna's ongoing Phase 3 safety and efficacy study of mRNA-1403 is fully enrolled in a second Northern Hemisphere season (2025-2026) with data expected in 2026, subject to case accruals.

Oncology therapeutics:

• Intismeran autogene : The Company is advancing mRNA-4157 in collaboration with Merck, with nine total Phase 2 and Phase 3 clinical trials underway across multiple tumor types including melanoma, non-small cell lung cancer (NSCLC), bladder cancer and renal cell carcinoma. This includes the recent initiation of a Phase 3 study of intismeran as monotherapy and in combination with KEYTRUDA QLEX for the treatment of high-risk Stage 1 NSCLC.

Fully enrolled studies include a Phase 3 adjuvant melanoma, a Phase 2 adjuvant renal cell carcinoma, and a Phase 2 adjuvant muscle invasive bladder cancer. Moderna expects Phase 3 adjuvant melanoma data potentially in 2026.

3

The Company recently announced an upcoming oral presentation on June 1 at 8 a.m. to 11 a.m. CT at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting highlighting positive five-year Phase 2b adjuvant melanoma data, which showed a sustained benefit with intismeran in combination with KEYTRUDA, reducing the risk of recurrence or death by 49% compared to KEYTRUDA alone.

• mRNA-4359 : Moderna's Phase 1/2 study of mRNA-4359, an investigational wholly-owned cancer antigen therapy, is ongoing. The Company recently presented mRNA-4359 data at the American Association for Cancer Research (AACR) 2026 Annual Meeting. The Phase 2 portion of the study includes cohorts in first-line metastatic melanoma, second-line+ metastatic melanoma and first-line metastatic NSCLC, and the Company expects a potential Phase 2 data readout in 2026.

Rare disease therapeutics:

• Propionic acidemia (PA) therapeutic : The Company's PA candidate, mRNA-3927, is in a registrational study and target enrollment has been reached. Moderna expects potential data in 2026.

• Methylmalonic acidemia (MMA) therapeutic : The Company is deferring its decision on a pivotal trial for mRNA-3705 until PA registrational data readout.

Moderna Corporate Updates

• Entered into a settlement agreement with Arbutus Biopharma Corporation and Genevant Sciences GmbH resolving all litigation worldwide

• Announced the initiation of Phase 3 study of mRNA-1018, Moderna's investigational pandemic influenza vaccine in collaboration with the Coalition for Epidemic Preparedness Innovations (CEPI)

Key 2026 Investor and Analyst Event Dates

• ASCO Investor Event: June 1 at 7:15 a.m. ET

• Science Day: June 25

• Analyst Day: November 12

Investor Call and Webcast Information

Moderna will host a live conference call and webcast at 8:00 a.m. ET on May 1, 2026. To access the live conference call via telephone, please register at the link below. Once registered, dial-in numbers and a unique pin number will be provided. A live webcast of the call will also be available under "Events and Presentations" in the Investors section of the Moderna website.

• Telephone: https://register-conf.media-server.com/register/BI367363edc35a45ecbc7dd27b7741ea34

• Webcast: https://investors.modernatx.com

The archived webcast will be available on Moderna's website approximately two hours after the conference call and will be available for one year following the call.

4

About Moderna

Moderna is a pioneer and leader in the field of mRNA medicine. Through the advancement of its technology platform, Moderna is reimagining how medicines are made to transform how we treat and prevent diseases. Since its founding, Moderna's mRNA platform has enabled the development of vaccines and therapeutics across infectious diseases, cancer, rare diseases and more.

With a global team and a unique culture, driven by the company's values and mindsets, Moderna's mission is to deliver the greatest possible impact to people through mRNA medicines. For more information about Moderna, please visit modernatx.com and connect with us on X, Facebook, Instagram, YouTube and LinkedIn.

MODERNA, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited, in millions, except per share data)

Three Months Ended March 31,

2026 2025

Revenue:

Net product sales $ 352  $ 86

Other revenue 1

37  22

Total revenue 389  108

Operating expenses:

Cost of sales 955  90

Research and development 649  856

Selling, general and administrative 173  212

Total operating expenses 1,777  1,158

Loss from operations (1,388) (1,050)

Interest income 72  90

Other expense, net (18) (4)

Loss before income taxes (1,334) (964)

Provision for income taxes 9  7

Net loss $ (1,343) $ (971)

Net loss per share

Basic and Diluted $ (3.40) $ (2.52)

Weighted average common shares used in calculation of net loss per share

Basic and Diluted 395  386

_______

1 Includes grant, collaboration, licensing and royalty, and stand-ready manufacturing revenue.

5

MODERNA, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(Unaudited, in millions)

March 31, December 31,

2026 2025

Assets

Current assets:

Cash and cash equivalents $ 1,908  $ 2,595

Investments 3,297  3,204

Accounts receivable, net 71  184

Inventory 146  153

Prepaid expenses and other current assets 348  408

Total current assets 5,770  6,544

Investments, non-current 2,251  2,336

Property, plant and equipment, net 2,086  2,134

Right-of-use assets, operating leases 706  719

Other non-current assets 675  605

Total assets $ 11,488  $ 12,338

Liabilities and Stockholders’ Equity

Current liabilities:

Accounts payable $ 161  $ 317

Accrued liabilities 1,912  1,386

Deferred revenue 102  99

Other current liabilities 220  185

Total current liabilities 2,395  1,987

Deferred revenue, non-current 154  153

Operating lease liabilities, non-current 645  653

Financing lease liabilities, non-current 13  20

Long-term debt 590  590

Other non-current liabilities 283  285

Total liabilities 4,080  3,688

Stockholders’ equity:

Additional paid-in capital 1,503  1,382

Accumulated other comprehensive income 25  45

Retained earnings 5,880  7,223

Total stockholders’ equity 7,408  8,650

Total liabilities and stockholders’ equity $ 11,488  $ 12,338

6

MODERNA, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited, in millions)

Three Months Ended March 31,

2026 2025

Operating activities

Net loss

$ (1,343) $ (971)

Adjustments to reconcile net loss to net cash used in operating activities:

Stock-based compensation 104  115

Depreciation and amortization 59  39

Amortization/accretion of investments (11) (19)

Loss on equity investments, net 2  8

Other non-cash items 6  2

Changes in assets and liabilities:

Accounts receivable, net 114  280

Prepaid expenses and other assets 54  46

Inventory 6  (8)

Right-of-use assets, operating leases 11  9

Accounts payable (120) (156)

Accrued liabilities 464  (381)

Deferred revenue 5  (29)

Operating lease liabilities (7) (5)

Other liabilities 26  33

Net cash used in operating activities

(630) (1,037)

Investing activities

Purchases of marketable securities (1,348) (1,764)

Proceeds from maturities of marketable securities 732  1,933

Proceeds from sales of marketable securities 602  688

Purchases of property, plant and equipment (62) (117)

Purchase of intangible asset —  (10)

Net cash (used in) provided by investing activities

(76) 730

Financing activities

Proceeds from issuance of common stock through equity plans 19  3

Tax payments related to net share settlements on equity awards (2) (1)

Changes in financing lease liabilities —  2

Net cash provided by financing activities

17  4

Effect of changes in exchange rates on cash and cash equivalents 1  —

Net decrease in cash, cash equivalents and restricted cash (688) (303)

Cash, cash equivalents and restricted cash, beginning of year 2,597  1,929

Cash, cash equivalents and restricted cash, end of period $ 1,909  $ 1,626

7

Spikevax®, mRESVIA®, mNEXSPIKE® and mCOMBRIAX® are registered trademarks of Moderna.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding: Moderna's 2026 financial framework, including its plan to deliver up to 10% revenue growth and GAAP operating expense reductions, and its projected year-end cash balance; Moderna’s multi-year revenue growth strategy, including geographic expansion and new product launches; Moderna's continued cost discipline; Moderna’s international strategic partnerships; expectations regarding mRNA-4157 Phase 3 adjuvant melanoma data in 2026; the potential of intismeran as monotherapy and in combination with KEYTRUDA QLEX; the potential of Moderna’s expanded oncology portfolio; pending and anticipated regulatory filings and potential approvals, including timing of approvals; Moderna's PDUFA date in the U.S. for mRNA-1010; and anticipated progress and milestones for Moderna's pipeline programs, including potential near-term data and other catalysts. In some cases, forward-looking statements can be identified by terminology such as "will," "may," "should," "could," "expects," "intends," "plans," "aims," "anticipates," "believes," "estimates," "predicts," "potential," "continue," or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna's control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include, among others, those risks and uncertainties described under the heading "Risk Factors" in Moderna's Annual Report on Form 10-K for the fiscal year ended December 31, 2025, filed with the U.S. Securities and Exchange Commission (SEC), and in subsequent filings made by Moderna with the SEC, which are available on the SEC's website at www.sec.gov. Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna's current expectations and speak only as of the date of this press release.

###

Moderna Contacts

Media:

Chris Ridley

Vice President, Head of Global Communications

+1 617-800-3651

Chris.Ridley@modernatx.com

8

Investors:

Lavina Talukdar

Senior Vice President & Head of Investor Relations

+1 617-209-5834

Lavina.Talukdar@modernatx.com

SOURCE: Moderna, Inc.

9

打开原文

施罗丁格季度收入结构变化

重要性3/5 中

法定季度披露直接对应SDGR,财务、合作和临床信息密集且可核对;发布时间较早,适合作为日报背景更新而非当日催化材料。

中文摘要

核心结论

Schrödinger(施罗丁格,SDGR)2026年第一季度总收入同比下降2%至5,859万美元,软件收入下滑被药物发现收入增长部分抵消;净亏损仍为6,003万美元。公司以合作里程碑、软件合同及合作方股权变现支撑资金与研发,正收缩自主临床扩张并为两项一期项目寻找合作伙伴。

重要性评级

评级:3/5(中)

这是SDGR的美国证券交易委员会Form 10-Q(美国季度报告),财务、合作和临床披露的证据强度高;但披露日为05/05(未给出具体时刻),距日报日期已有约两个月,主要用于更新基本面底稿。

关键事实

  • 2026年第一季度收入5,859万美元,2025年同期为5,955万美元;软件产品与服务收入从4,497万美元降至3,556万美元,药物发现收入从1,024万美元升至2,288万美元。
  • 当季净亏损6,003万美元,去年同期为5,981万美元;经营活动现金流流出1,483万美元。截至03/31,现金、现金等价物、受限现金及有价证券合计4.064亿美元。
  • 年度合同价值ACV(年度合同价值)为2,840万美元,高于去年同期的2,540万美元;公司说明该指标受合同起止、续约和收入确认影响,不能替代美国通用会计准则收入或预测收入。
  • 诺华于2025年1月支付1.5亿美元首付款;截至03/31,相关合作尚未确认里程碑收入,初始项目潜在里程碑总额最高22.72亿美元。
  • 百时美施贵宝合作仅剩一个神经系统靶点,SDGR截至03/31已确认3,200万美元里程碑收入,未来潜在里程碑最高4.82亿美元。
  • 公司在04/27宣布礼来拟收购其共同创立的Ajax Therapeutics;SDGR截至2025年末持有Ajax已发行股份的5.8%,交易尚待惯常交割条件满足。
  • SGR-3515一期初步数据截至01/30:40名患者完成安全性评估,100毫克及以上剂量的17名可评估患者中11名疾病稳定;3级及以上治疗相关不良事件占32.5%。
  • 公司计划完成SGR-1505和SGR-3515的一期剂量递增试验,但不再独立推进其他临床或临床前项目;与2025年5月重组结合后,预计完全落实可节省约7,000万美元。

作者观点与证据

该文件为公司向美国证券交易委员会提交的法定披露,重点呈现经营结果、合同权利、现金资源和风险因素。收入、亏损、现金及已确认收入可由财务报表核对;潜在里程碑、版税、成本节约、合作推进和临床前景均含条件,依赖合作方决定、研发结果及管理层预期。

与相关标的的关系

SDGR的软件收入下降、药物发现收入增长、现金储备和持续亏损共同决定其短期财务轮廓。诺华、百时美施贵宝和礼来相关安排提供潜在付款、版税或股权回报路径,但尚未构成确定收入;自主管线后续发展对外部合作的依赖上升。

时效性与限制

报告发布于05/05(未给出具体时刻),覆盖截至03/31的季度,适合作为SDGR历史财务与合作状态的高质量来源,不足以替代07/11当日的价格、最新临床更新或交易进展。原文为公司披露,临床结果为早期、小样本数据;合作里程碑与交易完成均存在不确定性。

后续跟踪

  • 软件收入、ACV与托管合同转换后的收入确认节奏。
  • 诺华、百时美施贵宝及礼来合作的项目进度、里程碑确认和Ajax交易交割。
  • SGR-1505与SGR-3515一期后续安全性、疗效及合作安排。
  • 经营现金流、现金储备和约7,000万美元成本节约的实际兑现情况。
原文
Schrodinger Quarterly Report for the Quarter Ended March 31, 2026

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

________________________________________

FORM 10-Q

________________________________________

(Mark One)

x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended March 31, 2026

OR

o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from          to

Commission File Number: 001-39206

________________________________________

Schrodinger, Inc.

(Exact Name of Registrant as Specified in its Charter)

________________________________________

Delaware 95-4284541

(State or other jurisdiction of

incorporation or organization) (I.R.S. Employer

Identification No.)

1540 Broadway , 24 th Floor

New York , NY

10036

(Address of principal executive offices) (Zip Code)

Registrant’s telephone number, including area code: ( 212 ) 295-5800

________________________________________

Securities registered pursuant to Section 12(b) of the Act:

Title of each class Trading

Symbol(s) Name of each exchange on which registered

Common stock, par value $0.01 per share SDGR The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes x No o

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes x No o

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer x

Accelerated filer o

Non-accelerated filer o Smaller reporting company o

Emerging growth company o

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. o

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes o No x

As of April 23, 2026, the registrant had 65,556,531 shares of common stock, $0.01 par value per share, and 9,164,193 shares of limited common stock, $0.01 par value per share, outstanding.

Table of Contents

Page

PART I.

FINANCIAL INFORMATION

Item 1.

Financial Statements

6

Condensed Consolidated Balance Sheets as of March 31, 2026 and December 31, 2025 (Unaudited)

6

Condensed Consolidated Statements of Operations for the thre e months ended March 31, 2026 and 2025 (Unaudited)

7

Condensed Consolidated Statements of Comprehensive Loss for the three months ended March 31, 2026 and 2025 (Unaudited)

8

Consolidated Statements of Stockholders’ Equity for the three months ended March 31, 2026 and 2025 (Unaudited)

9

Condensed Consolidated Statements of Cash Flows for the three months ended March 31, 2026 and 2025 (Unaudited)

10

Notes to Condensed Consolidated Financial Statements (Unaudited)

11

Item 2.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

31

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

44

Item 4.

Controls and Procedures

44

PART II.

OTHER INFORMATION

45

Item 1.

Legal Proceedings

45

Item 1A.

Risk Factors

45

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

103

Item 3.

Defaults Upon Senior Securities

103

Item 4.

Mine Safety Disclosures

103

Item 5.

Other Information

103

Item 6.

Exhibits

104

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CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q, or this Quarterly Report, contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act and Section 21E of the Securities Exchange Act of 1934, as amended, that involve substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this Quarterly Report, including statements regarding our strategy, future operations, future financial position, future revenue, projected costs, prospects, plans and objectives of management, are forward-looking statements. The words “aim,” “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “goal,” “intend,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” or the negative of these words or other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

The forward-looking statements in this Quarterly Report include, among other things, statements about:

• the potential advantages of our physics-based computational platform;

• our strategic plans to accelerate the growth of our software business and acquire new customers;

• our research and development efforts for our proprietary drug discovery programs and our computational platform, including the initiative to expand our computational platform to predict toxicology risk in early drug discovery;

• our drug discovery collaborations, including the initiation, timing, progress and results of such collaborations;

• our estimates or expectations regarding any milestone or other payments we may receive from drug discovery collaborations, including pursuant to our collaboration agreement with Novartis Pharma AG;

• our proprietary drug discovery programs, including the initiation, timing, progress, and results of our preclinical studies and clinical trials;

• our plans to discover and develop product candidates and to maximize their commercial potential by advancing such product candidates ourselves or in collaboration with others;

• our plans to leverage the synergies between our businesses;

• the timing of, the ability to submit applications for, and the ability to obtain and maintain regulatory approvals for any product candidates we or one of our collaborators may develop;

• the potential advantages of our drug discovery collaborations and our proprietary drug discovery programs;

• the rate and degree of market acceptance of our software solutions;

• the rate and degree of market acceptance and clinical utility of any product we or any of our collaborators may develop;

• our estimates regarding the potential market opportunity for our software solutions and any product candidate we or any of our collaborators may develop;

• our sales and marketing capabilities and strategy;

• our intellectual property position;

• our ability to identify technologies with significant commercial potential that are consistent with our commercial objectives;

• our expectations regarding our ability to fund our operating expenses and capital expenditure requirements with our cash, cash equivalents, and marketable securities;

• our expectations related to the use of our cash, cash equivalents, and marketable securities;

• our estimated costs and reduction in operating expenses resulting from the restructuring of our operations;

• our expectations related to the key drivers of our performance;

• the impact of government laws and regulations;

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• our competitive position and expectations regarding developments and projections relating to our competitors and any competing products, technologies, or therapies that are or become available;

• our ability to maintain and establish collaborations or obtain additional funding;

• our reliance on key personnel and our ability to identify, recruit, and retain skilled personnel; and

• the potential impact of geopolitical and global economic developments, including tariffs, trade restrictions, regulatory pricing requirements, and public health epidemics or pandemics.

We may not actually achieve the plans, intentions, or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions, and expectations disclosed in the forward-looking statements we make. We have included important factors in the cautionary statements included in this Quarterly Report, particularly in “Risk Factor Summary” and Part II, Item 1A. “Risk Factors” below, that we believe could cause actual results or events to differ materially from the forward-looking statements that we make. Moreover, we operate in a competitive and rapidly changing environment. New risks and uncertainties emerge from time to time, and it is not possible for us to predict all risks and uncertainties that could have an impact on the forward-looking statements contained in this Quarterly Report. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, collaborations, in-licensing arrangements, joint ventures, or investments we may make or enter into.

You should read this Quarterly Report and the documents that we file with the Securities and Exchange Commission with the understanding that our actual future results may be materially different from what we expect. The forward-looking statements contained in this Quarterly Report are made as of the date of this Quarterly Report, and we do not assume any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.

In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this Quarterly Report, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete. Our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain and investors are cautioned not to unduly rely upon these statements.

Unless the context otherwise requires, we use the terms “company,” “we,” “us,” and “our” in this Quarterly Report to refer to Schrödinger, Inc. and its consolidated subsidiaries.

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RISK FACTOR SUMMARY

Our business is subject to a number of risks of which you should be aware before making an investment decision. Below we summarize what we believe are the principal risk factors but these risks are not the only ones we face, and you should carefully review and consider the full discussion of our risk factors in the section titled “Risk Factors”, together with the other information in this Quarterly Report.

• We have a history of significant operating losses, and we expect to incur losses over the next several years.

• If we are unable to increase sales of our software, increase revenue from our drug discovery collaborations, or if we and our current and future collaborators are unable to successfully develop and commercialize drug products, our revenues may be insufficient for us to achieve or maintain profitability.

• Our quarterly and annual results may fluctuate significantly, which could adversely impact the value of our common stock.

• If our existing customers do not renew their licenses, do not buy additional solutions from us, or renew at lower prices, our business and operating results will suffer.

• A significant portion of our revenues are generated by sales to life sciences industry customers, and factors that adversely affect this industry could adversely affect our software sales.

• The markets in which we participate are highly competitive, and if we do not compete effectively, our business and operating results could be adversely affected.

• We may never realize a return on our investment of resources and cash in our drug discovery collaborations.

• Although we believe that our computational platform has the potential to identify more promising molecules than traditional methods and to accelerate drug discovery, our efforts in using our platform technology to discover and design molecules with therapeutic potential may not result in the discovery and development of commercially viable products for us or our collaborators.

• We may not be successful in our efforts to identify, discover or develop product candidates and may fail to capitalize on programs, collaborations, or product candidates that may present a greater commercial opportunity or for which there is a greater likelihood of success.

• As a company, we have very limited experience in clinical development, which may adversely impact the likelihood that we will be successful in advancing our programs.

• We will likely require additional capital to fund our operations. If we are unable to raise additional capital on terms acceptable to us or at all or generate cash flows necessary to maintain or expand our operations, we may not be able to compete successfully, which would harm our business, operations, and financial condition.

• Conducting successful clinical trials requires the enrollment of a sufficient number of patients, and suitable patients may be difficult to identify and recruit.

• We rely on, and plan to continue to rely on, third parties to conduct our clinical trials, and those third parties may not perform satisfactorily, including failing to meet deadlines for the completion of such trials, which may prevent or delay our ability to seek or obtain marketing approval for or commercialize our product candidates or otherwise harm our business.

• The outcome of preclinical studies and early clinical trials may not be predictive of the success of later clinical trials, and the results of our clinical trials may not satisfy the requirements of the U.S. Food and Drug Administration or other comparable foreign regulatory authorities.

• If we fail to comply with our obligations under our existing license agreements with Columbia University, under any of our other intellectual property licenses, or under any future intellectual property licenses, or otherwise experience disruptions to our business relationships with our current or any future licensors, we could lose intellectual property rights that are important to our business.

• If we are unable to obtain, maintain, enforce, and protect patent protection for our technology and product candidates or if the scope of the patent protection obtained is not sufficiently broad, our competitors could develop and commercialize technology and products similar or identical to ours, and

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our ability to successfully develop and commercialize our technology and product candidates may be adversely affected.

• Our internal information technology systems, or those of our third-party vendors, contractors, or consultants, may fail or suffer security breaches, loss or leakage of data, and other disruptions, which could result in a material disruption of our services, compromise sensitive information related to our business, or prevent us from accessing critical information, potentially exposing us to liability or otherwise adversely affecting our business.

• Our future success depends on our ability to retain key executives and to attract, retain, and motivate qualified personnel.

• We are pursuing multiple business strategies and may expand our development and regulatory capabilities, and as a result, we may encounter difficulties in managing our multiple business units and our growth, which could disrupt our operations.

• Our executive officers, directors, and principal stockholders, if they choose to act together, have the ability to influence all matters submitted to stockholders for approval.

• Our actual operating results may differ significantly from our guidance.

5

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PART I—FINANCIAL INFORMATION

Item 1. Financial Statements.

SCHRÖDINGER, INC. AND SUBSIDIARIES

Condensed Consolidated Balance Sheets (Unaudited)

(in thousands, except for share and per share amounts)

Assets March 31, 2026 December 31, 2025

Current assets:

Cash and cash equivalents $ 260,255   $ 230,517

Restricted cash (includes related party amounts of $ 0 and $ 72 , respectively)

7,464   6,868

Marketable securities 138,704   164,947

Accounts receivable, net of allowance for doubtful accounts of $ 440 and $ 440 (includes related party amounts of $ 0 and $ 100 , respectively)

27,253   83,041

Unbilled and other receivables, net of allowance for unbilled receivables of $ 140 and $ 140

20,930   21,352

Prepaid expenses 9,353   12,540

Total current assets 463,959   519,265

Property and equipment, net 20,447   19,456

Equity investments 39,826   73,647

Goodwill 4,791   4,791

Right of use assets - operating leases 100,198   102,736

Other assets 4,966   6,265

Total assets $ 634,187   $ 726,160

Liabilities and Stockholders' Equity:

Current liabilities:

Accounts payable $ 11,945   $ 11,452

Accrued payroll, taxes, and benefits 24,776   39,264

Deferred revenue 103,111   112,853

Lease liabilities - operating leases 16,013   16,412

Other accrued liabilities 13,697   9,155

Total current liabilities 169,542   189,136

Deferred revenue, long-term 59,019   78,877

Lease liabilities - operating leases, long-term 90,943   92,816

Other liabilities, long-term 1,135   1,278

Total liabilities 320,639   362,107

Commitments and contingencies (Note 5)

Stockholders' equity:

Preferred stock, $ 0.01 par value. Authorized 10,000,000 shares; zero shares issued and outstanding at March 31, 2026 and December 31, 2025, respectively

—   —

Common stock, $ 0.01 par value. Authorized 500,000,000 shares; 65,383,310 and 64,515,380 shares issued and outstanding at March 31, 2026 and December 31, 2025, respectively

654   645

Limited common stock, $ 0.01 par value. Authorized 100,000,000 shares; 9,164,193 shares issued and outstanding at March 31, 2026 and December 31, 2025, respectively

92   92

Additional paid-in capital 1,001,662   992,015

Accumulated deficit ( 688,832 ) ( 628,806 )

Accumulated other comprehensive (loss) income ( 28 ) 107

Total stockholders' equity 313,548   364,053

Total liabilities and stockholders' equity $ 634,187   $ 726,160

See accompanying notes to unaudited condensed consolidated financial statements.

6

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SCHRÖDINGER, INC. AND SUBSIDIARIES

Condensed Consolidated Statements of Operations (Unaudited)

(in thousands, except for share and per share amounts)

Three Months Ended March 31,

2026 2025

Revenues:

Software products and services (includes related party revenue of $ 3 and $ 9 , respectively)

$ 35,560   $ 44,972

Drug discovery 22,879   10,236

Contribution (includes related party revenue of $ 72 and $ 4,343 , respectively)

148   4,343

Total revenues 58,587   59,551

Cost of revenues:

Software products and services 10,863   9,112

Drug discovery 16,310   14,452

Contribution 1,867   4,863

Total cost of revenues 29,040   28,427

Gross profit 29,547   31,124

Operating expenses:

Research and development 43,824   45,844

Sales and marketing 11,603   10,367

General and administrative (includes related party expense of $ 165 and $ 109 , respectively)

22,914   25,802

Total operating expenses 78,341   82,013

Loss from operations ( 48,794 ) ( 50,889 )

Other (expense) income:

Change in fair value of equity investments ( 13,487 ) ( 13,095 )

Other income 2,663   4,204

Total other expense ( 10,824 ) ( 8,891 )

Loss before income taxes ( 59,618 ) ( 59,780 )

Income tax expense 408   28

Net loss $ ( 60,026 ) $ ( 59,808 )

Net loss per share of common and limited common stockholders, basic and diluted: $ ( 0.81 ) $ ( 0.82 )

Weighted average shares used to compute net loss per share of common and limited common stockholders, basic and diluted: 73,989,137 73,057,916

See accompanying notes to unaudited condensed consolidated financial statements.

7

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SCHRÖDINGER, INC. AND SUBSIDIARIES

Condensed Consolidated Statements of Comprehensive Loss (Unaudited)

(in thousands)

Three Months Ended March 31,

2026 2025

Net loss $ ( 60,026 ) $ ( 59,808 )

Changes in market value of investments, net of tax:

Unrealized loss on marketable securities ( 135 ) ( 130 )

Comprehensive loss $ ( 60,161 ) $ ( 59,938 )

See accompanying notes to unaudited condensed consolidated financial statements.

8

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SCHRÖDINGER, INC. AND SUBSIDIARIES

Condensed Consolidated Statements of Stockholders’ Equity (Unaudited)

(in thousands, except for share amounts)

Common stock Limited common

stock Additional

paid-in

capital Accumulated

deficit Accumulated other comprehensive income (loss) Total stockholders’

equity

Shares Amount Shares Amount

Balance at December 31, 2025 64,515,380   $ 645   9,164,193   $ 92   $ 992,015   $ ( 628,806 ) $ 107   $ 364,053

Unrealized loss on marketable securities —  —  —  —  —  —  ( 135 ) ( 135 )

Issuances of common stock upon stock option exercises 185,915   2  —  —  581   —  —  583

Issuance of common stock upon vesting of RSUs and PRSUs 682,015   7   —  —  ( 7 ) —  —  —

Stock-based compensation —  —  —  —  9,073   —  —  9,073

Net loss —  —  —  —  —  ( 60,026 ) —  ( 60,026 )

Balance at March 31, 2026 65,383,310   $ 654   9,164,193   $ 92   $ 1,001,662   $ ( 688,832 ) $ ( 28 ) $ 313,548

Balance at December 31, 2024 63,710,409   $ 637   9,164,193   $ 92   $ 946,037   $ ( 525,541 ) $ 220   $ 421,445

Unrealized loss on marketable securities —  —  —  —  —  —  ( 130 ) ( 130 )

Issuances of common stock upon stock option exercises 48,198   1   —  —  422   —  —  423

Issuance of common stock upon vesting of RSUs and PRSUs 420,395   4   —  —  ( 4 ) —  —  —

Stock-based compensation —  —  —  —  11,574   —  —  11,574

Net loss —  —  —  —  —  ( 59,808 ) —  ( 59,808 )

Balance at March 31, 2025 64,179,002   $ 642   9,164,193   $ 92   $ 958,029   $ ( 585,349 ) $ 90   $ 373,504

See accompanying notes to unaudited condensed consolidated financial statements.

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SCHRÖDINGER, INC. AND SUBSIDIARIES

Condensed Consolidated Statements of Cash Flows (Unaudited)

(in thousands)

Three Months Ended March 31,

2026 2025

Cash flows from operating activities:

Net loss $ ( 60,026 ) $ ( 59,808 )

Adjustments to reconcile net loss to net cash (used in) provided by operating activities:

Change in fair value of equity investments 13,487   13,095

Depreciation and amortization 1,476   1,589

Stock-based compensation 9,073   11,574

Noncash investment accretion ( 664 ) ( 861 )

Loss on disposal of property and equipment 11   —

Decrease (increase) in assets:

Accounts receivable, net (includes related party amounts of $ 100 and $ 0 , respectively)

55,788   215,345

Unbilled and other receivables 422   ( 6,332 )

Reduction in the carrying amount of right of use assets - operating leases 2,538   2,222

Prepaid expenses and other assets 4,486   ( 788 )

Increase (decrease) in liabilities:

Accounts payable 455   1,344

Accrued payroll, taxes, and benefits ( 14,488 ) ( 20,616 )

Deferred revenue ( 29,600 ) ( 10,804 )

Lease liabilities - operating leases ( 2,272 ) ( 1,669 )

Other accrued liabilities 4,480   ( 228 )

Net cash (used in) provided by operating activities ( 14,834 ) 144,063

Cash flows from investing activities:

Purchases of property and equipment ( 2,507 ) ( 596 )

Proceeds from disposition and sale of equity investments, net 20,334   —

Purchases of marketable securities ( 34,055 ) ( 27,556 )

Proceeds from maturity of marketable securities 60,827   58,784

Net cash provided by investing activities 44,599   30,632

Cash flows from financing activities:

Proceeds from issuances of common stock upon stock option exercises 583   423

Principal payments on finance leases ( 14 ) ( 14 )

Net cash provided by financing activities 569   409

Net increase in cash and cash equivalents and restricted cash 30,334   175,104

Cash and cash equivalents and restricted cash, beginning of period 237,385   162,657

Cash and cash equivalents and restricted cash, end of period $ 267,719   $ 337,761

Supplemental disclosure of cash flow and noncash information

Cash paid for income taxes $ 266   $ 139

Supplemental disclosure of non-cash investing and financing activities

Purchases of property and equipment in accounts payable 78   13

Purchases of property and equipment in accrued liabilities —   25

See accompanying notes to unaudited condensed consolidated financial statements.

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SCHRÖDINGER, INC. AND SUBSIDIARIES

Notes to Condensed Consolidated Financial Statements (Unaudited)

For the three months ended March 31, 2026 and 2025

(in thousands, except for share and per share amounts and note 3(d))

(1)     Description of Business

Schrödinger, Inc. (the "Company") has developed a differentiated, physics-based computational platform that enables discovery of high-quality, novel molecules for drug development and materials applications more rapidly and at a lower cost, compared to traditional methods. The Company's software platform is licensed by biopharmaceutical and industrial companies, academic institutions, and government laboratories around the world. The Company is also applying its computational platform to advance a broad pipeline of drug discovery programs in collaboration with leading biopharmaceutical companies. In addition, the Company uses its computational platform to discover novel molecules for its pipeline of proprietary drug discovery programs, which the Company is advancing through preclinical and clinical development.

Liquidity, Capital Resources and Funding Requirements

The Company has funded its operations to date from the sale of equity securities, from sales of software solutions and from upfront payments, research funding and milestone payments from drug discovery collaborations, and from distributions on account of, or proceeds from the sale of, the Company's equity stakes in its collaborators. The Company's operating cash flows are impacted by the magnitude and timing of its software sales and by the magnitude and timing of its drug discovery milestone achievements and research funding fees.

On February 28, 2024, the Company filed a universal shelf registration statement on Form S-3 which allows for the offering and selling of an indeterminate number of shares of common stock, preferred stock, depositary shares or warrants, or an indeterminate principal amount of debt securities, from time to time pursuant to one or more offerings at prices and terms to be determined at the time of the sale.

As of March 31, 2026, the Company had cash, cash equivalents, restricted cash, and marketable securities of $ 406.4 million.

(2)     Significant Accounting Policies

(a) Recently Issued Accounting Pronouncements

In November 2024, the Financial Accounting Standards Board (the "FASB") issued Accounting Standards Update ("ASU") No. 2024-03, Income Statement — Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40) — Disaggregation of Income Statement Expenses, which requires disclosure in the notes to the financial statements of specified information about certain costs and expenses. This standard is effective for annual periods beginning after December 15, 2026, and interim periods within annual periods beginning after December 15, 2027, on a prospective basis, with early adoption and retrospective application permitted. The Company has not yet adopted ASU 2024-03 and is still evaluating the impact of the adoption on its consolidated financial statements.

Recently Adopted Accounting Pronouncements

In July 2025, the FASB issued ASU No. 2025-05, Financial Instruments—Credit Losses (Topic 326) — Measurement of Credit Losses for Accounts Receivable and Contract Assets , which provides a practical expedient for estimating expected credit losses. The amendments are effective for annual reporting periods beginning after December 15, 2025, including interim periods within those annual periods, on a prospective basis, with early adoption permitted. The Company adopted this new standard effective January 1, 2026, with no material impact on its consolidated financial statements.

In September 2025, the FASB issued ASU No. 2025-07, Derivatives and Hedging (Topic 815) and Revenue from Contracts with Customers (Topic 606) — Derivatives Scope Refinements and Scope Clarification for Share-Based Noncash Consideration from a Customer in a Revenue Contract , which refines the scope of the guidance on derivatives by adding a new scope exception for certain non-exchange-traded contracts that have an underlying based on operations or activities specific to one of the parties to the contract, and clarifies the interaction between the guidance on revenue from contracts with customers and the guidance on derivatives and equity investments for share-based noncash consideration

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from a customer for the transfer of goods or services. The amendments are effective for annual reporting periods beginning after December 15, 2026, including interim periods within those annual periods, with early adoption permitted. The Company adopted this new standard effective January 1, 2026, with no material impact on its consolidated financial statements.

(b) Basis of Presentation and Use of Estimates

The accompanying unaudited condensed consolidated financial statements and the related interim disclosures have been prepared in accordance with U.S. generally accepted accounting principles ("U.S. GAAP") and pursuant to the rules and regulations of the Securities and Exchange Commission ("SEC") for the interim financial information. These unaudited condensed consolidated financial statements include all adjustments necessary, consisting of only normal recurring adjustments, to fairly state the financial position and the results of the Company’s operations and cash flows for interim periods in accordance with U.S. GAAP. Certain information and footnote disclosures normally included in financial statements prepared in accordance with U.S. GAAP have been condensed or omitted as permitted by the SEC’s rules and regulations for interim reporting. Interim period results are not necessarily indicative of results of operations or cash flows for a full year or any subsequent interim period. The accompanying unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, which was filed with the SEC on February 25, 2026.

The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities at the date of the consolidated financial statements, and the reported amounts of revenues and expenses during the reporting period. Significant estimates include the assumptions used in the allocation of revenue and estimates regarding the progress of completing performance obligations under collaboration agreements. Actual results could differ from those estimates, and such differences may be material to the unaudited condensed consolidated financial statements.

(c) Reclassifications of Prior Year Presentation

Certain prior period amounts have been reclassified to conform to the current period presentation. In connection with the preparation of the Company's unaudited condensed consolidated financial statements, the Company combined software contribution revenue with drug discovery contribution revenue and now presents these revenues collectively as contribution revenue. In addition, the Company combined software contribution cost of revenues with drug discovery contribution cost of revenues and now presents contribution cost of revenues separately from software cost of revenues and drug discovery cost of revenues.

These changes were made to better reflect the varying nature of revenue recognition. The reclassifications had no impact on total revenue, gross profit, operating loss, net loss, or cash flows for any period presented in this Quarterly Report.

(d) Principles of Consolidation

The Company’s unaudited condensed consolidated financial statements include the accounts of Schrödinger, Inc. and its wholly owned subsidiaries. All intercompany balances and transactions have been eliminated in consolidation. The functional currency for foreign entities is the U.S. dollar. The Company accounts for investments over which it has significant influence, but not a controlling financial interest, using the equity method.

(e) Restricted Cash

Restricted cash consists of letters of credit held with the Company’s financial institution related to facility leases, certificates of deposit held as collateral for its credit card facility, and funds received from certain grants which are restricted to their use. These items are classified as current in the Company’s balance sheets based on their maturity or the term of the grant.

(f) Concentrations

Financial instruments that potentially subject the Company to concentrations of credit risk consist primarily of trade receivables and contract assets, which represent contracted unbilled receivables.

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The Company does not require customers to provide collateral to support accounts receivable. If deemed necessary, credit reviews of significant new customers may be performed prior to extending credit. The determination of a customer’s ability to pay requires judgment, and failure to collect from a customer can adversely affect revenue, cash flows, and results of operations.

As of March 31, 2026, three customers accounted for 21 %, 18 %, and 11 % of total accounts receivable, respectively. As of December 31, 2025, one customer accounted for 10 % of total accounts receivable. As of March 31, 2026, two customers accounted for 24 % and 13 % of total contract assets, respectively. As of December 31, 2025, three customers accounted for 21 %, 12 %, and 10 % of total contract assets, respectively.

For the three months ended March 31, 2026, two customers accounted for 22 % and 18 % of total revenue, respectively. For the three months ended March 31, 2025, one customer accounted for 21 % of total revenue.

(g) Income Taxes

The Company records deferred tax assets and liabilities for the expected future tax consequences of temporary differences between the financial statement carrying amounts and the tax basis of the assets and liabilities. Deferred tax assets are reduced by a valuation allowance when it is estimated to become more likely than not that a portion of the deferred tax assets will not be realized. Accordingly, the Company currently maintains a full valuation allowance against U.S. federal and state net deferred tax assets.

The Company recognizes the benefit of a tax position in the consolidated financial statements in the period during which, based on all available evidence, management believes it is more likely than not that the position will be sustained upon examination, including the resolution of appeals or litigation processes, if any. Interest and penalties accrued on unrecognized tax benefits are included within income tax expense in the consolidated financial statements.

(h) Equity Investments

In the normal course of business, the Company has entered, and may continue to enter, into collaboration agreements with companies to perform drug and materials design services for such companies in exchange for equity ownership stakes in such companies. If it is determined that the Company has control over the investee, the investee is consolidated in the financial statements. If the investee is consolidated with the Company and less than 100% of the equity is owned by the Company, the Company will present non-controlling interest to represent the portion of the investee owned by other investors. If it is determined that the Company does not have control over the investee, the Company evaluates the investment for the ability to exercise significant influence.

Equity investments over which the Company has significant influence may be accounted for under equity method accounting in accordance with Accounting Standards Codification ("ASC") Topic 323, Equity Method and Joint Ventures . If it is determined that the Company does not have significant influence over the investee, and there is no readily determinable fair value for the investment, the equity investment may be accounted for at cost less impairment, in accordance with ASC Topic 321, Investments - Equity Securities.

For further information regarding the Company’s equity investments, see Note 4, Fair Value Measurements and Note 10, Equity Investments.

(i) Net Loss per Share Attributable to Common and Limited Common Stockholders

The outstanding equity of the Company consists of common stock and limited common stock. The Company considers all limited common stock to be participating securities as the holders are entitled to the same dividend rights as holders of common stock and therefore net income (loss) attributable to common and limited common stockholders is identical for both classes.

Undistributed earnings allocated to the participating securities are subtracted from net income in determining net income (loss) attributable to common and limited common stockholders. Basic net income (loss) per share is computed by dividing net income (loss) attributable to common and limited common stockholders by the weighted-average number of shares of common and limited common stock outstanding during the period.

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For the calculation of diluted net income, net income attributable to common and limited common stockholders for basic net income is adjusted by the effect of dilutive securities, including awards under the Company’s equity compensation plans. Diluted net income per share attributable to common and limited common stockholders is computed by dividing the resulting net income attributable to common and limited common stockholders by the weighted-average number of fully diluted shares of common and limited common stock outstanding.

(3)     Revenue Recognition

Revenue is recognized upon transfer of control of promised products or services to customers in an amount that reflects the consideration to which the Company expects to be entitled in exchange for promised goods or services. The Company’s performance obligations are satisfied either over time or at a point in time, which can result in different revenue recognition patterns.

The following table illustrates the timing of the Company’s revenue recognition patterns:

Three Months Ended March 31,

2026 2025

Software products and services – point in time 24.2   % 43.0   %

Software products and services – over time 36.5   32.5

Drug Discovery – point in time —   2.1

Drug Discovery – over time 39.1   15.1

Contribution – point in time —   —

Contribution – over time 0.2   7.3

(a) Software Products and Services

The Company enters into contracts that can include various combinations of licenses, products and services, most of which are distinct and are accounted for as separate performance obligations. For contracts with multiple performance obligations, the Company allocates the transaction price of the contract to each performance obligation on a relative standalone selling price ("SSP") basis. Revenue is recognized net of any sales and value-added taxes collected from customers and subsequently remitted to governmental authorities.

The Company's software business derives revenue from four sources: (i) on-premise software license fees, (ii) hosted software subscription fees, (iii) software maintenance fees, and (iv) professional services fees.

On-premise software. The Company's on-premise software license arrangements grant customers the right to use its software on their own in-house servers or their own cloud instances for a specified term, typically for one year , though in recent years, the Company has entered into a small number of large multi-year on-premise software license agreements. The Company recognizes revenue for on-premise software license fees upfront, either upon transfer of control of the license or the effective date of the agreement, whichever is later. In instances where the timing of the transfer of control differs from the timing of invoicing, the Company considers whether a significant financing component exists. The Company has elected the practical expedient to not assess for significant financing where the term is less than one year. The Company's updates and upgrades are not integral to maintaining the utility of the software licenses. Payments typically are received upfront or annually.

Hosted software. Hosted software revenue consists primarily of fees to provide the Company's customers with hosted licenses, which allows these customers to access the Company's cloud-based software solution on their own hardware without taking control of the licenses, and is recognized ratably over the term of the arrangement, which is typically one year , though in recent years, the Company has entered into a small number of large multi-year hosted software license agreements. When a customer enters into a hosted arrangement for which revenue is recognized over time, the amount paid upfront that is not recognized in the current period is included in deferred revenue in the Company's statement of financial position until the period in which it is recognized.

Software maintenance . Software maintenance includes technical support, updates, and upgrades related to the Company's on-premise software licenses. Software maintenance revenue is recognized ratably over the term of the

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arrangement. Software maintenance activities are performed in connection with the use of the Company's on-premise software.

Professional services . Professional services include training, technical setup, installation or assisting customers with modeling services, where the Company uses its software to perform tasks such as virtual screening on behalf of the Company’s customers. These services are generally not related to the core functionality of the Company's software and are recognized as revenue when resources are consumed.

The following table presents the revenue recognized from the sources of software products and services revenue:

Three Months Ended March 31,

2026 2025

On-premise software $ 14,180   $ 25,423

Hosted software 12,080   10,872

Software maintenance 6,662   6,796

Professional services 2,638   1,881

Total software revenue $ 35,560   $ 44,972

(b) Drug Discovery

Revenue from drug discovery and collaboration services contracts includes revenue from research services and the achievement of milestones.

Research services revenue is generally recognized over time, typically by measuring the progress toward complete satisfaction of the relevant performance obligation using an appropriate input method based on the services promised to the customer, such as costs incurred and hours expended. This method of recognizing revenue requires the Company to make estimates of the work required to complete the performance obligation in order to determine the progress towards completion. Payments for research services are generally due upfront at the start of a contract or periodically through the contract term.

In addition, the Company is generally entitled to receive variable consideration as certain milestones are achieved. The Company estimates the amount of variable consideration using the most likely amount method at contract inception and at the end of each reporting period. The Company evaluates milestones on a case-by-case basis, including whether there are factors outside the Company’s control that could result in a significant reversal of revenue, and the likelihood and magnitude of a potential reversal. If achievement of a milestone is not considered probable or the event is outside of the Company's control, the Company constrains variable consideration to exclude the milestone payment until it is deemed probable of achievement and that a significant reversal in revenue would not occur. Upon removal of the constraint on variable consideration, revenue may be recognized at a point in time or over time by applying the allocation guidance of ASC Topic 606, Revenue from Contracts with Customers ("Topic 606").

As of March 31, 2026, there were no milestones not yet achieved that were determined to be probable of achievement, and no corresponding drug discovery milestone revenue was recognized for the three months ended March 31, 2026. As of March 31, 2025, milestones not yet achieved that were determined to be probable of achievement totaled $ 2,000 , of which $ 487 was recognized as drug discovery milestone revenue for the three months ended March 31, 2025.

(c) Contribution

Software contribution revenue. Software contribution revenue consists of funds received under non-reciprocal agreements, as amended, with Gates Ventures, LLC and the Bill & Melinda Gates Foundation. The agreements are an unconditional non-exchange contribution without restrictions. Revenue is recognized annually, when invoiced or as costs are incurred and conditions are met, in accordance with ASC Topic 958, Not-for-Profit Entities ("Topic 958"), as the agreements are not an exchange transaction.

The agreement, as amended, with Gates Ventures, LLC was originally entered into in June 2020, and further extended through August 13, 2026, and provides for total additional consideration of up to $ 9,000 . Revenue is recognized

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annually, when invoiced, in accordance with Topic 958. No revenue was recognized on this agreement during the three months ended March 31, 2026 and 2025. As of both March 31, 2026 and December 31, 2025, the Company had no deferred revenue balance related to this agreement. As of both March 31, 2026 and December 31, 2025, the Company had no accounts receivable related to this agreement.

The agreement, as amended, with the Bill & Melinda Gates Foundation was originally entered into in July 2024, and subsequently extended through April 2026, to fund the initiative to accelerate the expansion of the Company's computational platform to predict toxicity associated with binding to off-target proteins. Revenue is recognized as costs are incurred and conditions are met in accordance with Topic 958. The Compan y recognized revenue of zero and $ 3,844 related to these agreements during the three months ended March 31, 2026 and 2025, respectively. As of both March 31, 2026 and December 31, 2025, the Company had no deferred revenue balances related to these agreements. As of March 31, 2026 and December 31, 2025, the Company had no accounts receivable related to these agreements.

Drug discovery contribution revenue. Drug discovery contribution revenue primarily consists of funds received under agreements with the Bill & Melinda Gates Foundation on a cost reimbursement basis to perform services aimed at accelerating drug discovery in women's health. The agreement began in November 2021 and the Company currently performs services aimed at accelerating drug discovery in women's health under an agreement with the Bill & Melinda Gates Foundation that extends through July 2026. Revenue is recognized as costs are incurred and conditions are met in accordance with Topic 958 . The Company recognized revenue of $ 72 and $ 499 related to these agreements during the three months ended March 31, 2026 and 2025, respectively. As of March 31, 2026 and December 31, 2025, the Company had deferred revenue balances related to these agreements of zero and $ 72 , respectively.

The following table presents the revenue recognized from the sources of contribution revenue:

Three Months Ended March 31,

2026 2025

Software contribution $ —   $ 3,844

Drug discovery contribution 148   499

Total contribution revenue $ 148   $ 4,343

(d) Collaboration and License Agreements

Bristol Myers-Squibb. On November 22, 2020, the Company entered into an exclusive, worldwide collaboration and license agreement with Bristol-Myers Squibb Company ("BMS"), pursuant to which the Company and BMS agreed to collaborate in the discovery, research and preclinical development of new small molecule compounds for disease indications in oncology, neurology, and immunology therapeutics areas. Under the agreement, the Company was initially responsible, at its own cost and expense, for the discovery of small molecule compounds directed to five specified biological targets pursuant to a mutually agreed research plan for each such target. In December 2022, the Company and BMS entered into an amendment to the agreement to include an additional target in neurology on terms similar to the original agreement. As a result of BMS electing not to proceed with further development of certain targets, there is one remaining neurology target under the agreement, as amended, as of March 31, 2026.

Once a development candidate meeting specified criteria for a target under the agreement has been identified by the Company, BMS will be solely responsible for the further development, manufacturing and commercialization of such development candidate at its own cost and expense. The Company, at its discretion, can further advance the development of any programs that have been returned by BMS .

Under the terms of the agreement, as amended, BMS paid the Company an initial upfront payment of $ 55.0 million in November 2020, an additional upfront payment in December 2022, and a program fee in December 2024. As of March 31, 2026, the Company is eligible to receive up to $ 482.0 million in total milestone payments related to the one remaining neurology target currently subject to the collaboration, consisting of up to $ 257.0 million in the aggregate for the achievement of certain specified research, development, and regulatory milestones and $ 225.0 million in the aggregate for the achievement of certain specified commercial milestones. As of March 31, 2026, the Company has recognized $ 32.0 million in revenue related to milestones under this agreement.

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The Company is also entitled to a tiered percentage royalty on annual net sales ranging from mid-single digits to low-double digits, subject to certain specified reductions. Royalties are payable by BMS on a licensed product-by-licensed product and country-by-country basis until the later of the expiration of the last valid claim covering the licensed product in such country, expiration of all applicable regulatory exclusivities in such country for such licensed product and the tenth anniversary of the first commercial sale of such licensed product in such country.

The Company assessed the collaboration and license agreement in accordance with Topic 606 and concluded that BMS is a customer based on the agreement structure. At inception, the Company identified one performance obligation for each of the five programs initially covered under the agreement, which includes research activities for each program and a license grant for the underlying intellectual property. The Company determined that the license grant for intellectual property is not separable from the research activities, as the research activities are expected to significantly modify or enhance the license grant over the period of service, and therefore are not distinct in the context of the contract.

The Company determined that the transaction price at the onset of the agreement was $ 55.0 million. Additional consideration to be paid to the Company upon the achievement of future milestone payments was excluded from the transaction price as it represents milestone payments that were not considered probable as of the inception date such that there is not a significant risk of revenue reversal.

The Company has allocated the transaction price of $ 55.0 million to each performance obligation based on the relative SSP of each performance obligation at inception. The Company determined the estimated SSP at contract inception of the research activities based on internal estimates of the costs to perform the services, inclusive of a reasonable profit margin. Significant inputs used to determine the total costs to perform the research activities included the length of time required, the internal hours expected to be incurred on the services and the number and costs of various studies that will be performed to complete the research plan.

During the three months ended March 31, 2026 and 2025, the Company recognized $ 0.7 million and $ 0.6 million, respectively, of revenue associated with the agreement based on the research activities performed and milestones achieved. As of March 31, 2026 and December 31, 2025, there was $ 2.5 million and $ 3.2 million, respectively, of deferred revenue related to the agreement, which was classified as either current or non-current in the condensed consolidated balance sheet based on the period the services are expected to be performed. As of both March 31, 2026 and December 31, 2025, the Company had no outstanding receivables for this collaboration.

Novartis. On November 11, 2024, the Company entered into a research collaboration and license agreement with Novartis Pharma AG ("Novartis"), pursuant to which the Company and Novartis agreed to collaborate on the discovery, research and preclinical development of small molecule compounds for targets in certain specified therapeutic areas. The agreement is intended to advance multiple development candidates for development and commercialization by Novartis. The Company also entered into an expanded three-year software agreement with Novartis that substantially increases Novartis' access to the Company’s computational predictive modeling technology and enterprise informatics platform. Under Topic 606, the research collaboration and license agreement as well as the three-year software agreement ("the agreements") are collectively accounted for as a single contract.

Under the terms of the research collaboration and license agreement, once a development candidate has been identified, Novartis will be solely responsible for the further development, manufacturing and commercialization of such development candidate.

Novartis agreed to pay the Company an initial upfront payment of $ 150.0 million under the terms of the research collaboration and license agreement, and the Company is eligible to receive up to $ 2.272 billion in total milestone payments across the initial programs. Such milestones consist of up to $ 892.0  million in discovery and development milestones and up to $ 1.38  billion in commercial milestones. The Company is also entitled to a tiered percentage royalty ranging from mid-single-digits to low double-digits on products commercialized by Novartis under the agreement, subject to certain specified reductions. For the three months ended March 31, 2026 and 2025, no revenue was recognized related to milestones under this agreement.

The Company assessed the research collaboration and license agreement in accordance with Topic 606 and concluded that Novartis is a customer based on the agreement structure. The promises identified by the Company include research activities for each program under the agreement, a license grant for the underlying intellectual property, and software licenses and services. The Company determined that the license grant for intellectual property is not separable from the research activities, as the research activities are expected to significantly modify or enhance the license grant over

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the period of service, and therefore are not distinct in the context of the contract. Software licenses and services provided under the agreement are considered distinct and are accounted for as separate performance obligations in accordance with Topic 606.

The Company has allocated the transaction price for the agreements to each performance obligation based on the relative SSP of each performance obligation at inception. The Company determined the estimated SSP of the research activities at contract inception based on internal estimates of the costs to perform the services, inclusive of a reasonable profit margin. Significant inputs used to determine the total costs to perform the research activities included the length of time required, the internal hours expected to be incurred on the services and the number and costs of various studies that will be performed to complete the research plan.

During the three months ended March 31, 2026 and 2025, the Company recognized $ 11.7 million and $ 5.7 million of revenue, respectively, associated with the research collaboration and license agreement. As of March 31, 2026 and December 31, 2025, there was $ 88.8 million and $ 100.5 million of deferred revenue, net of contract assets, respectively, related to the agreements, which was classified as either current or non-current in the condensed consolidated balance sheets based on the period the services are expected to be performed. As of both March 31, 2026 and December 31, 2025, the Company had no outstanding receivables for this collaboration.

(e) Significant Judgments

Significant judgments and estimates are required under Topic 606. Due to the complexity of certain contracts, the actual revenue recognition treatment required under Topic 606 for the Company’s arrangements may be dependent on contract-specific terms and may vary in some instances.

The Company's contracts with customers often include but are not limited to promises to transfer multiple software products and services, including training, professional services, technical support services, and rights to unspecified updates, as well as collaborative research services, licenses to intellectual properties, and customer options. Determining whether licenses and services are distinct performance obligations that should be accounted for separately, or are not distinct and therefore should be accounted for together, requires significant judgment. Some arrangements, such as most of the Company's term-based software license arrangements, may include multiple software licenses, a right to updates or upgrades to the licensed software products, and technical support. The Company has concluded that such promised licenses and services are separate distinct performance obligations. In other arrangements, including collaboration services arrangements, the licenses and certain services may not be distinct from each other.

The Company is required to estimate the total consideration expected to be received from contracts with customers, including any variable consideration. For collaborative arrangements, under which the Company is eligible to receive variable consideration in the form of milestones payments, judgment is required to evaluate whether the milestones are considered probable of being achieved. If it is probable that a significant revenue reversal would not occur, the constraint is removed and value of the associated milestone is included in the estimated transaction price using the most likely amount method based on contractual requirements and historical experience. Once the estimated transaction price is established, amounts are allocated to the performance obligations that have been identified. The transaction price is allocated to each separate performance obligation on a relative SSP basis consistent with the allocation objectives of Topic 606.

Judgment is required to determine the SSP for each distinct performance obligation. The Company rarely licenses or sells products on a standalone basis, so the Company is required to estimate the SSP for each performance obligation. In instances where the SSP is not directly observable because the Company does not sell the license, product, or service separately, the Company determines the SSP using information that includes historical discounting practices, market conditions, cost-plus analysis, and other observable inputs. The Company typically has more than one SSP for individual software license performance obligations due to the stratification of those items by volume of sales, classes of customers and other relevant circumstances. In these instances, the Company may use information such as the size and geographic region of the customer in determining the SSP. Professional service revenue is recognized as costs and hours are incurred, and judgment is required in estimating both the project status and the costs incurred or hours expended.

If a group of agreements are so closely related to each other that they are, in effect, part of a single arrangement, such agreements are deemed to be one arrangement for revenue recognition purposes. The Company exercises significant judgment to evaluate the relevant facts and circumstances in determining whether the separate agreements should be accounted for separately or as, in substance, a single arrangement. The Company's judgments about whether a group of

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contracts comprises a single arrangement can affect the allocation of consideration to the distinct performance obligations, which could have an effect on results of operations for the periods involved.

Judgment is required to determine the total costs to perform research activities, which include the length of time required, the internal hours expected to be incurred on the services, and the number and costs of various studies that may be performed by third parties to complete the research plan.

Generally, the Company has not experienced significant returns or refunds to customers.

The Company's estimates related to revenue recognition may require significant judgment and a change in these estimates could have an effect on the Company's results of operations during the periods involved.

(f) Contract Balances

The timing of revenue recognition may differ from the timing of invoicing to customers and these timing differences result in receivables, contract assets, or contract liabilities (deferred revenue) on the condensed consolidated balance sheets. The Company records a contract asset when revenue is recognized prior to invoicing. A deferred revenue liability is recorded when revenue is expected to be recognized subsequent to invoicing. For the Company's time-based software agreements, customers are generally invoiced at the beginning of the arrangement for the entire term, though when the term spans multiple years the customers may be invoiced on an annual basis. For certain drug discovery agreements where the milestones are deemed probable in a period prior to when the milestone is achieved, the Company records a contract asset for the full value of the milestone.

For the three months ended March 31, 2026 and 2025, the Company recognized $ 24,804 and $ 29,493 , of revenue, respectively, that was included in software deferred revenue at the end of the respective preceding periods. For the three months ended March 31, 2026 and 2025, the Company recognized $ 22,397 and $ 7,755 , of revenue, respectively, that was included in drug discovery deferred revenue at the end of the respective preceding periods. For the three months ended March 31, 2026 and 2025, the Company recognized $ 131 and $ 4,471 , of revenue, respectively, that was included in contribution deferred revenue at the end of the respective preceding periods. All other deferred revenue activity is due to the timing of invoices in relation to the timing of revenue, as described above.

Contract assets are included in unbilled and other receivables within the condensed consolidated balance sheets and are transferred to receivables when the Company invoices the customer.

Contract balances were as follows:

As of March 31, 2026 As of December 31, 2025

Contract assets $ 19,196   $ 19,698

Deferred revenue, short-term:

Software products and services 60,755   66,695

Drug discovery 42,356   46,027

Contribution —   131

Deferred revenue, long-term:

Software products and services 6,202   7,333

Drug discovery 52,817   71,544

Contribution —   —

Backlog represents contracted but unsatisfied performance obligations that had not yet been billed to the customer or included in deferred revenue. Remaining performance obligations represent total backlog and deferred revenue.

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Remaining performance obligations were as follows:

As of March 31, 2026 As of December 31, 2025

Deferred revenue Total Total

Software products and services $ 66,957   $ 74,028

Drug discovery 95,173   117,571

Contribution —   131

Total deferred revenue 162,130   191,730

Backlog

Software products and services 31,630   31,036

Drug discovery 17,206   17,100

Contribution —   —

Total backlog 48,836   48,136

Remaining performance obligations

Software products and services 98,587   105,064

Drug discovery 112,379   134,671

Contribution —   131

Total remaining performance obligations $ 210,966   $ 239,866

The Company expects to recognize as revenue approximately 55 % of its March 31, 2026 remaining performance obligations in the next 12 months and the remainder thereafter. The Company expects to recognize as revenue approximately 74 % of its March 31, 2026 remaining software performance obligation in the next 12 months and the remainder thereafter. The Company expects to recognize as revenue approximately 39 % of its March 31, 2026 remaining drug discovery performance obligation in the next 12 months and the remainder thereafter.

Payment terms and conditions vary by contract type, although terms typically require payment within 30 to 60 days. In instances where the timing of revenue recognition differs from that of invoicing, the Company has determined that its contracts generally do not include a significant financing component. The primary purpose of invoicing terms is to provide customers with simplified and predictable ways of purchasing the Company's products and services, not to facilitate financing arrangements.

(g) Deferred Sales Commissions

The Company has applied the practical expedient for sales commission expense, as any material compensation paid to sales representatives to obtain a contract relates to a period of one year or less. The Company has not capitalized any costs related to sales commissions.

(4)     Fair Value Measurements

Various inputs are used in determining the fair value of the Company’s financial assets and liabilities. These inputs are summarized into the following three broad categories:

Level 1 – quoted prices in active markets for identical securities

Level 2 – other significant observable inputs, including quoted prices for similar securities, interest rates, credit risk, etc.

Level 3 – significant unobservable inputs, including the Company’s own assumptions in determining fair value

The inputs or methodology used for valuing securities are not necessarily an indication of the risk associated with investing in those securities. Marketable securities, which consist primarily of corporate and U.S. government agency bonds, are classified as available for sale and fair value did not differ significantly from carrying value as of March 31, 2026 and December 31, 2025.

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The following table presents information about the Company’s assets measured at fair value as of March 31, 2026:

Level 1 Level 2 Level 3 Total

Assets:

Cash and cash equivalents and restricted cash $ 267,719   $ —   $ —   $ 267,719

Marketable securities —   138,704   —   138,704

Equity investments 32,820   —   —   32,820

Total $ 300,539   $ 138,704   $ —   $ 439,243

The following table presents information about the Company’s assets measured at fair value as of December 31, 2025:

Level 1 Level 2 Level 3 Total

Assets:

Cash and cash equivalents and restricted cash $ 237,385   $ —   $ —   $ 237,385

Marketable securities —   164,947   —   164,947

Equity investments 66,641   —   —   66,641

Total $ 304,026   $ 164,947   $ —   $ 468,973

Unrealized gains and losses arising from changes in fair value of the Company’s equity investments are classified within change in fair value of equity investments in the condensed consolidated statements of operations.

For further information regarding the Company’s equity investments, see Note 10, Equity Investments.

(5)     Commitments and Contingencies

(a)    Leases

The Company has multiple operating leases for office space and a finance lease for equipment that expire at various dates through 2037. The Company has elected the package of practical expedients under the transition guidance of ASC Topic 842, Leases , to exclude short-term leases from the balance sheet and to combine lease and non-lease components. The Company classifies finance lease right of use assets under property and equipment, net and finance short-term and long-term lease liabilities under other accrued liabilities and other liabilities, long-term, respectively.

Upon inception of a lease, the Company determines if an arrangement is a lease, if it is classified as an operating or finance lease, if it includes options to extend or terminate the lease, and if it is reasonably certain that the Company will exercise the options. Lease cost, representing lease payments over the term of the lease and any capitalizable direct costs less any incentives received, is recognized on a straight-line basis over the lease term as lease expense.

In determining the present value of lease payments, the Company uses its incremental borrowing rate based on the information available at the lease commencement date if the rate implicit in the lease is not readily determinable. Upon execution of a new lease, the Company performs an analysis to determine its incremental borrowing rate using its current borrowing rate, adjusted for various factors including level of collateralization and lease term. As of March 31, 2026, the remaining weighted average lease term for operating and finance leases was 10 years.

Variable and short-term lease costs for the Company's operating and finance leases were immaterial for the three months ended March 31, 2026 and 2025. Additional details of the Company's operating and finance leases are presented in the following table:

Three Months Ended March 31,

2026 2025

Lease costs $ 4,497   $ 4,508

Cash paid for leases 4,212   4,186

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Maturities of operating and finance lease liabilities as of March 31, 2026 under noncancelable leases were as follows:

Year ending December 31:

Remainder of 2026 $ 12,899

2027 15,928

2028 14,931

2029 14,520

2030 14,624

Thereafter 82,884

Total future minimum lease payments 155,786

Less: imputed interest ( 48,778 )

Present value of future minimum lease payments 107,008

Less: current portion of lease payments ( 16,065 )

Lease liabilities, long-term $ 90,943

(b)    Legal Matters

From time to time, the Company may become involved in routine litigation arising in the ordinary course of business. While the results of such litigation cannot be predicted with certainty, management believes that the final outcome of such matters is not likely to have a material adverse effect on the Company’s financial position or results of operations or cash flows.

(6)     Income Taxes

The Company estimates an annual effective income tax rate based on projected results for the year and applies this rate to income before taxes to calculate income tax expense. Any refinements made due to subsequent information that affects the estimated annual effective income tax rate are reflected as adjustments in the current period.

For the three months ended March 31, 2026 and 2025, the Company’s income tax expense was $ 408 and $ 28 , respectively. For the three months ended March 31, 2026 and 2025, the difference between the effective rate and the statutory rate was primarily attributed to the application of research and development credits and the change in the valuation allowance against net deferred tax assets.

The Company recognizes the effect of income tax positions only if those positions are "more likely than not" of being sustained. As of March 31, 2026, the Company had $ 9,750 of unrecognized tax benefits. Interest and penalties accrued on unrecognized tax benefits are recorded as tax expense within the unaudited condensed consolidated financial statements.

The Company and its subsidiaries file U.S. federal income tax returns and various state, local and foreign income tax returns. As of March 31, 2026, the Company’s statutes of limitations are open for all federal and state tax returns filed after the years ended December 31, 2022 and 2021, respectively. Net operating loss ("NOL") and credit carryforwards for all years are subject to examination and adjustments for the three years following the year in which the carryforwards are utilized. The Company is not currently under Internal Revenue Service or state examination.

Pursuant to Internal Revenue Code Sections 382 and 383, the utilization of NOLs and other tax attributes may be substantially limited due to cumulative changes in ownership greater than 50% that may have occurred or could occur during applicable testing periods. The Company has performed an analysis through December 31, 2025 and determined no such ownership change had occurred. If such an ownership change were to occur subsequent to December 2025, the Company's ability to use its NOLs and research and development tax credit carryforwards may be materially limited.

On July 4, 2025, the One Big Beautiful Bill Act (“OBBBA”) was signed into law enacting significant changes to U.S. tax and related laws. Some of the provisions of the new tax law affecting corporations include but are not limited to expensing of domestic research expenses, increasing the limit of the business interest expense deduction to thirty percent of EBITDA, and permitting one hundred percent bonus depreciation on eligible property acquired after January 19, 2025. The

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impact of the tax law changes from the OBBBA is included in the Company's financial statements for the fiscal quarter ended March 31, 2026. There has been no material change to the Company's effective income tax rate or its net deferred federal income tax assets as a result of the OBBBA as the Company maintains a full valuation allowance for all U.S. deferred tax assets.

(7)     Stockholders’ Equity

(a)    Common Stock

As of March 31, 2026, the Company had authorized 500,000,000 shares of common stock with a par value of $ 0.01 per share. Holders of common stock are entitled to one vote per share, to receive dividends, if and when declared by the board of directors, and upon liquidation or dissolution, to receive a portion of the assets available for distributions to stockholders, subject to preferential amounts owed to holders of the Company’s preferred stock, if any.

Common stockholders have no preemptive or other subscription rights and there are no redemption or sinking fund provisions with respect to such shares. The rights, preferences and privileges of holders of the common stock are subject to and may be adversely affected by the right of the holders of shares of any series of preferred stock that the Company may designate and issue in the future.

In February 2024, the Company entered into an amended and restated sales agreement with Leerink Partners LLC ("Leerink Partners"), as sales agent, with respect to an at-the-market offering program (the "ATM") under which the Company could offer and sell, from time to time pursuant to its Registration Statement on Form S-3, shares of common stock, having an aggregate offering price of up to $ 250,000 , through Leerink Partners. The amended and restated sales agreement amends and restates the original sales agreement that the Company entered into with Leerink Partners with respect to the ATM in May 2023. No shares of common stock were sold under the ATM during the three months ended March 31, 2026 and 2025. As of March 31, 2026, the Company had $ 241,132 of common stock remaining available for sale under the ATM.

(b)    Limited Common Stock

As of March 31, 2026, the Company had authorized 100,000,000 shares of limited common stock with a par value of $ 0.01 per share. Holders of limited common stock are entitled to one vote per share, however, the holders of limited common stock shall not be entitled to vote such shares in any election of directors or on the removal of directors. Holders of limited common stock are entitled to the same dividend rights as holders of common stock, if and when declared by the board of directors, and upon liquidation or dissolution, to receive a portion of the assets available for distributions to stockholders, subject to preferential amounts owed to holders of the Company's preferred stock, if any. Holders of the Company's limited common stock have the right to convert each share of limited common stock into one share of the Company's common stock.

Limited common stockholders have no preemptive or other subscription rights and there are no redemption or sinking fund provisions with respect to such shares. The rights, preferences and privileges of holders of the limited common stock are subject to and may be adversely affected by the right of the holders of shares of any series of preferred stock that the Company may designate and issue in the future.

(c)    Preferred Stock

As of March 31, 2026, the Company had authorized 10,000,000 shares of undesignated preferred stock with a par value of $ 0.01 per share. The Company's board of directors has the discretion to determine the rights, preferences, privileges, and restrictions, including voting rights, dividend rights, conversion rights, redemption privileges, and liquidation preferences, of each series of preferred stock .

(8)     Stock-Based Compensation

Stock Incentive Plans

As of March 31, 2026, the Company's stock incentive plans included the 2010 Stock Plan (the "2010 Plan"), the 2020 Equity Incentive Plan (the "2020 Plan"), the 2021 Inducement Equity Incentive Plan, as amended (the "2021 Plan"), and the 2022 Equity Incentive Plan, as amended (the "2022 Plan") (together, the "Plans").

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The 2022 Plan provides for the award of incentive stock options, nonstatutory stock options, stock appreciation rights, restricted stock awards, restricted stock units, other stock-based awards, and cash-based awards to employees, directors, consultants or advisors. Shares of common stock subject to outstanding awards granted under the 2020 Plan and the 2010 Plan that expire, terminate, or are otherwise surrendered, cancelled, forfeited, or repurchased by the Company are available for issuance under the 2022 Plan.

The 2021 Plan provides for the award of incentive stock options, nonstatutory stock options, stock appreciation rights, restricted stock awards, restricted stock units, and other stock-based awards to persons who were not previously an employee or director of the Company or who are commencing employment with the Company following a bona fide period of non-employment, in either case, as an inducement material to such person’s entry into employment with the Company and in accordance with the requirements of the Nasdaq Stock Market Rule 5635(c)(4). Neither consultants nor advisors are eligible to participate in the 2021 Plan.

The 2020 Plan provided for the award of incentive stock options, nonstatutory stock options, stock appreciation rights, restricted stock awards, restricted stock units, and other stock-based awards to employees, directors, consultants or advisors. As of June 15, 2022, the effective date of the 2022 Plan, no further awards will be made under the 2020 Plan. Any options or awards outstanding under the 2020 Plan are governed by the terms of the 2020 Plan.

The 2010 Plan provided for the granting of incentive stock options and nonstatutory stock options to employees, directors, consultants or advisors. As of the effective date of the 2020 Plan, no further awards will be made under the 2010 Plan. Any options or awards outstanding under the 2010 Plan are governed by the terms of the 2010 Plan.

As of March 31, 2026 and December 31, 2025, there were 2,364,521 and 4,841,655 shares available for grant under the Plans, respectively. The following table presents classification of stock-based compensation expense within the unaudited condensed consolidated statements of operations:

Three Months Ended March 31,

2026 2025

Cost of sales $ 1,210   $ 1,403

Research and development 2,740   3,507

Sales and marketing 764   920

General and administrative 4,359   5,744

Total stock-based compensation $ 9,073   $ 11,574

Restricted Stock Units

Each restricted stock unit ("RSU") represents the right to receive one share of the Company's common stock upon vesting. The fair value of RSUs granted by the Company was calculated based upon the Company's closing stock price on the date of the grant, and the stock-based compensation expense is recognized over the vesting period. RSUs generally vest over four years with 25 % of the grants vesting at the end of the first year and the remaining vesting annually over the following three years.

There were 1,494,482 and 1,294,694 RSUs granted during the three months ended March 31, 2026 and 2025, respectively. The weighted average grant date fair value for each RSU granted during the three months ended March 31, 2026 and 2025 was $ 12.14 and $ 21.25 , respectively.

As of March 31, 2026, there was $ 52,413 of unrecognized compensation cost related to RSUs granted under the Plans, which is expected to be recognized over a weighted average period of 2.92 years. During the three months ended March 31, 2026 and 2025, 662,334 and 405,545 RSUs vested, respectively. The fair value of RSUs vested during the three months ended March 31, 2026 and 2025 was $ 8,604 and $ 9,212 , respectively.

Performance-Based Restricted Stock Units

In March 2026, March 2025, March 2024, and February 2023, the Company awarded performance-based restricted stock units ("PRSUs") under the 2022 Plan. Each PRSU represents a contingent right to receive one share of common stock upon the achievement of specified performance goals. The fair value of PRSUs granted by the Company

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was calculated based upon the Company's closing stock price on the date of the grant, and the stock-based compensation expense is recognized when the grant date is determined and performance conditions are probable of achievement. At the point when performance conditions are considered probable of achievement, the Company records stock-based compensation expense with a cumulative catch-up expense in the period first recognized and on a straight-line basis over the remaining period for which the performance criteria are expected to be completed.

In March 2026, the Company awarded to all executive officers PRSUs for a maximum of 498,375 shares (based on 150 % achievement of the applicable performance conditions outlined in the awards), with a target award of 332,250 PRSUs (based on 100 % achievement of the applicable performance conditions), and a threshold award of 166,125 PRSUs (based on 50 % achievement of the applicable performance conditions) (the "2026 PRSUs"). The 2026 PRSUs were considered granted under ASC 718, Compensation—Stock Compensation ("Topic 718") in March 2026. The 2026 PRSUs are scheduled to vest, if at all, upon the certification by the Company's compensation committee of the achievement of the applicable performance conditions following the filing of the Company's Annual Report on Form 10-K for the fiscal year ending December 31, 2028.

In March 2025, the Company awarded to all executive officers PRSUs for a maximum of 173,438 shares (based on 150 % achievement of the applicable performance conditions outlined in the awards), with a target award of 115,625 PRSUs (based on 100 % achievement of the applicable performance conditions), and a threshold award of 57,813 PRSUs (based on 50 % achievement of the applicable performance conditions) (the "2025 PRSUs"). The 2025 PRSUs were considered granted under Topic 718 in March 2025. 18,750 2025 PRSUs were forfeited in June 2025, representing the number of shares that would have vested at the maximum level for the applicable milestones. The remaining 2025 PRSUs are scheduled to vest, if at all, upon the certification by the Company's compensation committee of the achievement of the applicable performance conditions following the filing of the Company's Annual Report on Form 10-K for the fiscal year ending December 31, 2027.

In March 2024, the Company awarded to all executive officers PRSUs for a maximum of 180,000 shares (based on 150 % achievement of the applicable performance conditions outlined in the awards), with a target award of 120,000 PRSUs (based on 100 % achievement of the applicable performance conditions), and a threshold award of 60,000 PRSUs (based on 50 % achievement of the applicable performance conditions) (the "2024 PRSUs"). The 2024 PRSUs were considered granted under Topic 718 in March 2024. 22,500 2024 PRSUs were forfeited in June 2025, representing the number of shares that would have vested at the maximum level for the applicable milestones. In March 2026, the Company's compensation committee determined the achievement of the PRSUs set to vest upon the certification by the Company's compensation committee following the filing of the Company's Annual Report on Form 10-K for the fiscal year ending December 31, 2026, subject to the continued provision of services by the holder to the Company through such vesting date. The Company's compensation committee determined that the applicable performance conditions had been met between target and maximum level for 50,275 of the PRSUs and at the maximum level for 94,500 of the PRSUs.

In February 2023, the Company awarded to certain executive officers PRSUs for a maximum of 62,693 shares (based on 150 % achievement of the applicable performance conditions outlined in the awards), with a target award of 41,795 PRSUs (based on 100 % achievement of the applicable performance conditions), and a threshold award of 20,898 PRSUs (based on 50 % achievement of the applicable performance conditions) (the "2023 PRSUs"). The 2023 PRSUs were considered granted under Topic 718 in February 2023. 13,215 2023 PRSUs were forfeited in June 2025, representing the number of shares that would have vested at the maximum level for the applicable milestones. In March 2026, the Company's compensation committee determined the achievement of the PRSUs set to vest upon the certification by the Company's compensation committee following the filing of the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2025. Of the PRSUs that were eligible to vest, the Company's compensation committee determined that the applicable performance conditions had been met at the target level for 10,994 of the PRSUs and between the threshold and target level for 8,687 of the PRSUs, all of which vested in March 2026, and that the applicable performance conditions had not been met for 16,496 PRSUs, representing the number of shares that would have vested at the maximum level for the applicable milestones, which were forfeited in March 2026.

In August 2022, the Company awarded 90,000 PRSUs to an executive officer, all of which are considered granted under Topic 718. In March 2025, the Company's compensation committee determined the achievement of the awards set to vest upon the certification by the Company's compensation committee following the filing of the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2024. Of the 27,000 PRSUs that were eligible to vest following the filing of the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2024, the Company's compensation committee determined that the applicable performance conditions had been met for 14,850 of the PRSUs, which vested in March 2025, and that the applicable performance conditions had not been met for 12,150 PRSUs,

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which were forfeited in March 2025. The Company's compensation committee also determined that the applicable performance conditions for 27,000 PRSUs that were eligible to vest following the filing of the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2025 could not be met and these awards were forfeited in March 2025.

The weighted average grant date fair value for each PRSU granted during the three months ended March 31, 2026 and 2025 was $ 12.15 and $ 21.24 , respectively. During the three months ended March 31, 2026 and 2025, 19,681 and 14,850 PRSUs vested, respectively.

Stock Options

Stock options must be granted at an exercise price not less than 100 % of the fair market value per share at the grant date. The board of directors or compensation committee determines the exercise price of the Company’s stock options based on the closing price of the common stock as reported on the Nasdaq Global Select Market on the date of the grant. The maximum contractual term of options granted under the Plans is typically 10 years, options generally vest over four years with 25 % of the shares underlying the option vesting at the end of the first year and the remaining vesting monthly over the following three years. In March 2025, March 2024, and February 2023, the Company granted the chief executive officer premium priced options to purchase 90,000 , 87,271 and 65,525 shares of common stock, respectively, with exercise prices equal to 110 % of the closing price of the Company's common stock on the date of grant.

During the three months ended March 31, 2026 and 2025, 185,915 and 48,198 options under the Plans were exercised for total proceeds of $ 583 and $ 423 , respectively.

The fair value of each option award is determined on the date of grant using the Black Scholes Merton option-pricing model. The calculation of fair value included several assumptions that require management’s judgment. The expected terms of options granted to employees during 2026 and 2025 were calculated using an average of historical exercises. The estimated volatility for the three months ended March 31, 2026 and 2025 incorporated a calculated volatility derived from a 50/50 blended approach using the Company's own historical closing prices of its shares of common stock for the expected term of the option with the historical closing prices of shares of common stock of similar entities whose share prices were publicly available for the expected term of the option. The risk-free interest rate was based on the U.S. Treasury constant maturities in effect at the time of grant for the expected term of the option. The Company accounts for forfeitures as they occur; as such, the Company does not estimate forfeitures at the time of grant.

Following are the weighted average valuation assumptions used for option awards during the periods presented:

Three Months Ended March 31,

2026 2025

Valuation assumptions

Expected dividend yield —   % —   %

Expected volatility 65   % 69   %

Expected term (years) 5.71 5.55

Risk-free interest rate 3.68   % 3.99   %

The weighted average grant date fair value per share of options granted during the three months ended March 31, 2026 and 2025 was $ 7.38 and $ 13.32 , respectively. The intrinsic value of options exercised during the three months ended March 31, 2026 and 2025 was $ 1,683 and $ 637 , respectively.

As of March 31, 2026, there was $ 24,531 of unrecognized compensation cost related to unvested stock options granted under the Plans, which is expected to be recognized over a weighted average period of 2.53 years. The fair value of shares vested during the three months ended March 31, 2026 and 2025 was $ 6,454 and $ 11,080 , respectively.

(9)     Net Loss per Share Attributable to Common and Limited Common Stockholders

The following table presents the calculation of basic and diluted net loss per share attributable to common and limited common stockholders for the periods presented (in thousands, except for share and per share data):

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Three Months Ended March 31,

2026 2025

Numerator:

Net loss attributable to Schrödinger common and limited common stockholders $ ( 60,026 ) $ ( 59,808 )

Denominator:

Weighted average shares used to compute net loss per share of common and limited common stockholders, basic and diluted: 73,989,137 73,057,916

Net loss per share of common and limited common stockholders, basic and diluted: $ ( 0.81 ) $ ( 0.82 )

For periods in which the Company reports net losses, basic net loss per share is the same as diluted net loss per share as the inclusion of all potential common shares and limited common shares outstanding would have been anti-dilutive. Potentially dilutive securities that were not included in the diluted per share calculations because they would be anti-dilutive were as follows:

Three Months Ended March 31,

2026 2025

Shares subject to outstanding common stock options 12,395,566 12,696,887

Shares subject to outstanding unvested RSUs and PRSUs 3,262,221 2,554,539

Total shares subject to outstanding common stock options and unvested RSUs and PRSUs 15,657,787 15,251,426

(10)     Equity Investments

(a)    Nimbus

The Company has no significant influence over Nimbus and accounts for its investment in Nimbus Therapeutics, LLC ("Nimbus") as a non-marketable security. As of both March 31, 2026 and December 31, 2025, the carrying value of the Nimbus investment was $ 2,436 . The Company has no obligation to fund Nimbus' losses in excess of its initial investment.

(b)    Ajax

In May 2021, the Company purchased 631,377 shares of Series B preferred stock of Ajax Therapeutics, Inc. ("Ajax") for $ 1,700 in cash. In April 2024, the Company purchased 1,416,450 shares of Series C preferred stock of Ajax for $ 3,000 in cash. The Company has concluded that its equity investment in Ajax should be valued as a non-marketable equity security as the Company does not exercise significant influence over Ajax.

As of both March 31, 2026 and December 31, 2025, the carrying value of the Company’s investment in Ajax was $ 4,498 .

(c)    Structure Therapeutics

In July 2021, the Company purchased 494,035 shares of Series B preferred stock of Structure Therapeutics Inc. ("Structure Therapeutics") for $ 2,000 in cash. In April 2022, the Company purchased an additional 148,210 shares of Series B preferred stock for $ 600 in cash. On February 7, 2023, Structure Therapeutics completed its initial public offering ("IPO"). Immediately upon the closing of Structure Therapeutics' IPO, all of the outstanding Series B preferred stock automatically converted into ordinary shares on a one -for-one basis. The Company purchased 275,000 American Depository Shares ("ADSs") at $ 15.00 per ADS in the IPO. Each ADS represents three ordinary shares. The Company accounts for its investment in Structure Therapeutics at fair value based on the closing price of Structure Therapeutics' ADSs as of the reporting date.

During the three months ended March 31, 2026, the Company sold a portion of its equity stake in Structure Therapeutics for net proceeds of $ 20,334 . The Company recorded a mark-to-market gain of $ 1,050 on the portion of the investment sold during the three months ended March 31, 2026. The Company recorded a mark-to-market loss of $ 14,537

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on the portion of the investment held during the three months ended March 31, 2026. During the three months ended March 31, 2025, the Company reported a mark-to-market loss of $ 13,095 on the Structure Therapeutics investment.

As of March 31, 2026 and December 31, 2025, the carrying value of the Company's investment in Structure Therapeutics was $ 32,820 and $ 66,641 , respectively.

(11)     Related Party Transactions

(a)    Board Member

For the three months ended March 31, 2026 and 2025, the Company paid consulting fees of $ 165 and $ 109 , respectively, to a member of its board of directors.

(b)    Bill & Melinda Gates Foundation

The Bill & Melinda Gates Foundation, an entity under common control with Bill & Melinda Gates Foundation Trust, a stockholder of the Company, issued a grant under which it agreed to pay the Company directly for certain licenses and services provided to a specified group of third-party organizations. Revenue recognized for services provided by the Company under this grant was zero and $ 9 for the three months ended March 31, 2026 and 2025, respectively.

For the three months ended March 31, 2026 and 2025, the Company recognized $ 72 and $ 499 , respectively, in contribution revenue related to funds received under an agreement with the Bill & Melinda Gates Foundation, aimed at accelerating drug discovery in women's health. As of March 31, 2026 and December 31, 2025, restricted cash on hand related to the arrangement was zero and $ 72 , respectively.

For the three months ended March 31, 2026 and 2025, the Company recognized zero and $ 3,844 in contribution revenue related to funds received under agreements with the Bill & Melinda Gates Foundation to fund the initiative to accelerate the expansion of the Company's computational platform to predict toxicity associated with binding to off-target proteins. There was no restricted cash on hand related to the arrangement as of March 31, 2026 and December 31, 2025.

As of March 31, 2026 and December 31, 2025, the Company had no receivables due from the Bill & Melinda Gates Foundation related to any of these agreements.

Gates Ventures, LLC is an entity under the control of William H. Gates III, who may be deemed to be the beneficial owner of more than 5 % of the Company’s voting securities. The agreement with Gates Ventures, LLC currently extends through August 13, 2026 and provides for total additional consideration of up to $ 9,000 . No revenue was recognized on this agreement for the three months ended March 31, 2026 and 2025. As of March 31, 2026 and December 31, 2025, the Company had no net receivables due from Gates Ventures, LLC.

(c)    Columbia University and Richard Friesner

During the year ended December 31, 2025, the Company entered into certain license agreements with the Trustees of Columbia University ("Columbia University"), separate from the licenses discussed in "Item 1. Business—License Agreements with Columbia University" in our Annual Report on Form 10-K for the fiscal year ended December 31, 2025. Dr. Richard Friesner, the William P. Schweitzer Professor of Chemistry at Columbia University and the principal investigator of the Friesner Research Group, a research laboratory within the Department of Chemistry at Columbia University, was the inventor of certain of the technologies licensed to the Company pursuant to certain of the Company's license agreements with Columbia University and is one of the Company's co-founders and a member of the Company's board of directors.

Revenue recognized for these additional licenses for the three months ended March 31, 2026 and 2025 was $ 3 and zero , respectively. As of March 31, 2026 and December 31, 2025, the Company had zero and $ 100 in outstanding receivables due from Columbia University related to these licenses.

(12)     Segment Reporting

The Company has determined that its chief executive officer ("CEO") is its chief operating decision maker ("CODM"). The Company’s CEO evaluates the financial performance of the Company based on two reportable segments: Software and Drug Discovery. The Software segment is focused on licensing the Company’s software to transform

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molecular discovery. The Drug Discovery segment is focused on building a portfolio of preclinical and clinical drug programs, internally and through collaborations.

The CODM reviews segment performance and allocates resources based upon segment revenue and segment gross profit of the Software and Drug Discovery reportable segments. Segment gross profit is derived by deducting cost of sales from U.S. GAAP revenue. Cost of sales are expenditures made that are directly attributable to the reportable segment. These expenditures are allocated to the segments based on headcount or by expenses directly incurred to support the Software or Drug Discovery segments. The reportable segment expenditures include compensation, supplies, and services from contract research organizations.

Certain cost items are not allocated to the Company’s reportable segments. These cost items primarily consist of non-drug discovery program related compensation and general operational expenses associated with the Company’s research and development, sales and marketing, and general and administrative activities. These costs are incurred by both segments and due to the integrated nature of the Company’s Software and Drug Discovery segments, any allocation methodology would be subjective and may not provide meaningful analysis.

Segment revenue is primarily earned in the United States and there are no intersegment revenues. Additionally, the Company reports assets on a consolidated basis and does not allocate assets to its reportable segments for purposes of assessing segment performance or allocating resources.

Presented below is financial information with respect to the Company’s reportable segments for the periods presented:

Three Months Ended March 31,

2026 2025

Segment revenues (1) :

Software $ 35,560   $ 48,816

Drug discovery 23,027   10,735

Total segment revenues 58,587   59,551

Segment cost of revenues (1) :

Software 12,300   13,522

Drug discovery 16,740   14,905

Total segment cost of revenues 29,040   28,427

Segment gross profit:

Software 23,260   35,294

Drug discovery 6,287   ( 4,170 )

Total segment gross profit 29,547   31,124

Unallocated (expense) income:

Research and development ( 43,824 ) ( 45,844 )

Sales and marketing ( 11,603 ) ( 10,367 )

General and administrative ( 22,914 ) ( 25,802 )

Change in fair value of equity investments ( 13,487 ) ( 13,095 )

Other income 2,663   4,204

Income tax expense ( 408 ) ( 28 )

Consolidated net loss $ ( 60,026 ) $ ( 59,808 )

(1)    Contribution activity is included within the segments to which the contribution activity relates as software contribution activity and drug discovery contribution activity share similar economic characteristics, respectively, with the software and drug discovery segments.

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Revenues by geographic area are determined based on the address provided by the Company's customers and partners. The following table sets forth revenues by geographic area for the three months ended March 31, 2026 and 2025:

Three Months Ended March 31,

2026 2025

United States $ 31,408   $ 29,663

EMEA 20,173   23,083

APAC 6,673   6,074

Rest of World 333   731

$ 58,587   $ 59,551

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Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.

You should read the following discussion and analysis of our financial condition and results of operations together with our unaudited condensed consolidated financial statements and related notes appearing elsewhere in this Quarterly Report. Some of the information contained in this discussion and analysis or set forth elsewhere in this Quarterly Report, including information with respect to our plans and strategy for our business and related financing, includes forward-looking statements that involve risks and uncertainties. As a result of many factors, including those factors set forth in Part II, Item 1A. “Risk Factors” of this Quarterly Report, our actual results could differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis. For further information regarding our forward-looking statements, see “Cautionary Note Regarding Forward-Looking Statements” in this Quarterly Report.

Overview

We are transforming the way therapeutics and materials are discovered. Our differentiated, physics-based computational platform enables discovery of high-quality, novel molecules for drug development and materials applications more rapidly and at a lower cost, compared to traditional methods. Our software platform is licensed by biopharmaceutical and industrial companies, academic institutions, and government laboratories around the world. We are applying our computational platform to advance a broad pipeline of drug discovery programs in collaboration with leading biopharmaceutical companies. In addition, we use our computational platform to discover novel molecules for our pipeline of proprietary drug discovery programs, which we are advancing through preclinical and clinical development.

We offer our customers a variety of software solutions that accelerate all stages of molecule discovery, design, and optimization. Since our founding, we have been primarily focused on developing our computational platform, which is capable of predicting critical properties of molecules with a high degree of accuracy, as well as advancing drug discovery programs both with our collaborators and on our own. We have devoted substantially all of our resources to introducing new capabilities and refining our software, conducting research and development activities, recruiting skilled personnel, and providing general and administrative support for these operations.

Over the last decade, we have entered into a number of collaborations with leading biopharmaceutical companies that have provided us with significant revenue and have the potential to produce additional milestone payments, option fees, and future royalties. In 2018, we began to develop a pipeline of proprietary drug discovery programs with the goal of using our platform to produce a portfolio of novel, high value therapeutics.

Financial Overview; Software Revenue and Collaborations

We have funded our operations to date from the sale of our equity securities, including our initial public offering and our follow-on public offering, from sales of our software solutions and from upfront payments, research funding and milestone payments from our drug discovery collaborations, and from distributions on account of, or proceeds from the sale of, our equity stakes in our collaborators.

On April 27, 2026, Eli Lilly and Company, or Lilly, and Ajax Therapeutics, Inc., or Ajax, a company co-founded by us, jointly announced Lilly's planned acquisition of Ajax. Under the terms of the agreement, Ajax shareholders could receive up to $2.3 billion in cash, inclusive of an upfront payment and subsequent payments upon the achievement of certain clinical and regulatory milestones. The transaction is subject to customary closing conditions. As of December 31, 2025, we held a 5.8% equity position in Ajax on an issued and outstanding basis.

We currently conduct our operations through two reportable segments: software and drug discovery. The software segment is focused on selling our software to transform drug discovery across the life sciences industry, as well as to customers in materials science industries. The drug discovery segment is focused on generating revenue from a diverse portfolio of preclinical and clinical programs, internally and through collaborations, that have advanced to various stages of discovery and development.

Our software segment generates revenue from software product licenses, hosted software subscriptions, software maintenance, professional services, and contributions. The revenue we generate through our software solutions from each of our customers varies largely depending on the type and number of software licenses our customers purchase from us. The licenses that our customers purchase from us provide them the ability to perform a certain number of calculations used in the design of molecules for drug discovery or materials science. The amount we charge per license depends on the specific software products our customers purchase from us, and the number of licenses needed to perform calculations per

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software product varies. With the exception of certain limited products, the number of licenses a customer requires is typically based on the scale at which they are running our software products and is not based on how many users have access to the software. As customers increase the number of licenses they purchase from us, they will typically be able to run a greater number of simultaneous instances of our products, thereby increasing the number of calculations they will be able to perform in parallel, subject to having enough computational capacity. We deliver our software through either (i) a product license that permits our customers to install the software solution directly on their own in-house hardware and use it for a specified term, or (ii) a subscription that allows our customers to access our cloud-based software solution on their own hardware without taking control of licenses.

Our collaboration agreements typically include upfront consideration, discovery, development, commercial and regulatory milestones, and royalties from future sales of commercialized products. We generate drug discovery revenue through the performance of specified research and development activities under our collaboration agreements and upon the achievement of specified discovery and development milestones, and we have the potential to generate drug discovery revenue from commercial and regulatory milestones, option fees, and royalties under our collaboration agreements. In the future, we may also derive drug discovery revenue from our collaborations from option fees, the achievement of regulatory and commercial milestones, and royalties on commercial drug sales. In addition to revenue from our collaborations, we may also derive drug discovery revenue from collaborating on or out-licensing our proprietary drug discovery programs when we believe it will help maximize the clinical and commercial opportunities for the program.

We are party to an exclusive, worldwide collaboration and license agreement with Bristol-Myers Squibb Company, or BMS, pursuant to which we and BMS agreed to collaborate in the discovery, research and development of small molecule compounds for biological targets in the oncology, neurology and immunology therapeutic areas. After mutual agreement on the targets(s) of interest, we are responsible for the discovery of development candidates. Once a development candidate meeting specified criteria for a target has been identified, BMS will be solely responsible for the development, manufacturing and commercialization of such development candidate. We are eligible to receive up to $482.0 million in total milestone payments for the one remaining neurology target currently subject to the collaboration, of which we have recognized $32.0 million as of March 31, 2026, as well as a tiered percentage royalty on net sales of each product commercialized by BMS ranging from mid-single digits to low-double digits, subject to certain specified reductions. See "Collaboration and License Agreements" in Note 3 to our unaudited condensed consolidated financial statements for additional information relating to this agreement.

In September 2022, we entered into a collaboration with Lilly under which we are responsible for the discovery and optimization of small molecule compounds addressing an immunology target. Lilly is responsible for the completion of preclinical development, clinical development and commercialization. Under the terms of the agreement, we received an upfront payment and we are eligible to receive up to $420.0 million in discovery, development and commercial milestone payments for the target. We are also eligible to receive low single- to low double-digit royalties on net sales of any products emerging from the collaboration in all markets. In February 2025, we expanded our research collaboration with Lilly to add an undisclosed target to the collaboration, which was subsequently terminated by Lilly in March 2026 for strategic reasons. The collaboration remains active with respect to the initial target.

In November 2024, we entered into a research collaboration and license agreement with Novartis Pharma AG, or Novartis, pursuant to which we and Novartis agreed to collaborate on the discovery, research and preclinical development of small molecule compounds for targets in certain specified therapeutic areas. The agreement is intended to advance multiple development candidates for development and commercialization by Novartis. Under the terms of the research collaboration and license agreement, Novartis paid us an initial upfront fee of $150.0 million in January 2025 and we are eligible to receive up to $2.272 billion in total milestone payments across the initial programs. Such milestones consist of up to $892.0 million in discovery and development milestones and up to $1.38 billion in commercial milestones. We are also entitled to a tiered percentage royalty on net sales of each product commercialized by Novartis ranging from mid single-digits to low double-digits on products commercialized by Novartis under the agreement, subject to certain specified reductions. No milestone revenue has been recognized as of March 31, 2026. In November 2024, we also entered into an expanded three-year software agreement with Novartis that substantially increases Novartis' access to our computational predictive modeling technology and enterprise informatics platform. See "Collaboration and License Agreements" in Note 3 to our unaudited condensed consolidated financial statements for additional information relating to the research collaboration and license agreement.

We generated revenue of $58.6 million and $59.6 million during the three months ended March 31, 2026 and 2025, respectively, representing a year-over-year decrease of 2%. Our net loss for the three months ended March 31, 2026 and 2025 was $60.0 million and $59.8 million, respectively.

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Our annual contract value, or ACV, was $28.4 million for the three months ended March 31, 2026, compared to $25.4 million for the three months ended March 31, 2025. With respect to contracts that have a duration of one year or less, or contracts of more than one year in duration that are billed annually, we define ACV as the contract value billed during the applicable period. For contracts with a duration of more than one year that are billed upfront, ACV in each period represents the total billed contract value divided by the term.

We present ACV as a supplemental operating metric because it provides a consistent measure of the underlying performance of our software business that is not affected by differences in revenue recognition timing across contract types, delivery models, or billing structures. ACV is particularly useful during our ongoing transition of customers from on-premise software arrangements to hosted software contracts. ACV should be viewed independently of revenue and does not represent revenue calculated in accordance with U.S. GAAP on an annualized basis, as it is an operating metric that can be impacted by contract execution start and end dates and renewal rates. ACV is not intended to be a replacement for, or forecast of, revenue.

Initiative with Bill & Melinda Gates Foundation

In July 2024, we launched an initiative to expand our computational platform to predict toxicity associated with binding to off-target proteins. The goal of this initiative is to develop a computational solution designed to improve the properties of drug development candidates and reduce the risk of development failure associated with binding to off-target proteins, which can be associated with serious side effects. The project is being funded initially by $19.5 million in grants from the Bill & Melinda Gates Foundation. We continue to advance our predictive toxicology initiative, which encompasses approximately 50 representative kinases in addition to multiple key anti-targets. We recently launched our predictive toxicology solution commercially and expect to make it available more broadly to our customers during 2026.

Proprietary Drug Discovery Programs

In June 2022, the U.S. Food and Drug Administration, or FDA, cleared our first investigational new drug application, or IND, for our MALT1 inhibitor, which we refer to as SGR-1505. Our ongoing Phase 1 clinical trial of SGR-1505 is designed as an open-label, multi-center dose escalation trial in patients with relapsed or refractory B-cell malignancies. The trial is designed to evaluate the safety, pharmacokinetics, pharmacodynamics, maximum tolerated dose, maximum administered dose and/or recommended dose of SGR-1505. Backfill cohorts evaluate additional pharmacokinetics, pharmacodynamics, preliminary anti-tumor activity, and safety to support the recommended dose.

In April 2024, the FDA cleared the IND we submitted for our novel Wee1/Myt1 inhibitor, which we refer to as SGR-3515. In July 2024, we initiated dosing in a Phase 1 clinical trial of SGR-3515 in patients with advanced solid tumors. The trial is a dose-escalation trial designed to evaluate the safety, tolerability and recommended Phase 2 dose of SGR-3515. Secondary and exploratory objectives of the trial include evaluating the pharmacokinetics and preliminary anti-tumor activity of SGR-3515.

In April 2026, we reported initial clinical data from our ongoing Phase 1 clinical trial of SGR-3515 in patients with advanced solid tumors. As of January 30, 2026, the data cut-off date, 40 patients were enrolled and evaluable for safety across eight dose levels of SGR-3515 (ranging from 15 mg to 225 mg). Based on the initial data, SGR-3515 was observed to be generally well tolerated on an intermittent dosing schedule. Treatment-related adverse events, or TRAEs, of any grade were reported in 72.5% of patients, with the most common (≥ 10%) being neutrophil count decreased (30%), nausea (25%), fatigue (25%), diarrhea (20%), and vomiting (10%). TRAEs of grade 3 or higher were reported in 32.5% of patients, with the most common (≥ 10%) being neutrophil count decreased (20%). Neutropenia, a mechanism-based hematological adverse event was transient, non-symptomatic, non-febrile and not leading to treatment discontinuation. Drug-related serious adverse events were reported in 4 participants, all of which were grade 3. One dose-limiting toxicity was observed (grade 3 AST increase) and there were two drug-related treatment discontinuations (grade 3 transaminitis). There were no cases of Hy's law observed and no deaths due to adverse events. Preliminary anti-tumor activity was observed with 64.7% of evaluable patients (11 of 17) achieving stable disease at dose levels of 100 mg and above, and pharmacodynamic data from paired tumor biopsies showed target inhibition of both Wee1 and Myt1.

Beyond our planned investments to complete our ongoing Phase 1 dose-escalation clinical trials of SGR-1505 and SGR-3515, we do not intend to initiate additional clinical trials or advance our other proprietary preclinical programs into clinical trials independently. We plan to explore strategic partnerships for the SGR-1505 and SGR-3515 programs to advance the development of these programs beyond our ongoing Phase 1 clinical trials. The phasing out of independent clinical development activities and associated cost reductions, together with the restructuring of our operations we

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announced in May 2025 are expected to result in savings of approximately $70 million, when fully completed and further improve and enhance our operational efficiency.

Components of Results of Operations

Software Products and Services Revenue

Our software business generates revenue from four sources: (i) on-premise software license fees, (ii) hosted software subscription fees, (iii) software maintenance fees, and (iv) professional services fees.

On-premise software. Our on-premise software license arrangements grant customers the right to use our software on their own in-house servers or their own cloud instances for a specified term, typically for one year, though in recent years, we have entered into a small number of large multi-year on-premise software license agreements. We recognize revenue for on-premise software license fees upfront, either upon transfer of control of the license or the effective date of the agreement, whichever is later.

Hosted software. Hosted software revenue consists primarily of fees to provide our customers with hosted licenses, which allows these customers to access our cloud-based software solution on their own hardware without taking control of the licenses, and is recognized ratably over the term of the arrangement, which is typically one year, though in recent years, we have entered into a small number of large multi-year hosted software license agreements. When a customer enters into a hosted arrangement for which revenue is recognized over time, the amount paid upfront that is not recognized in the current period is included in deferred revenue in our statement of financial position until the period in which it is recognized.

We have accelerated our efforts to transition customers from on-premise software arrangements to hosted software contracts. As a result of this transition, we expect future quarterly and annual revenue trends to be impacted, as revenue associated with hosted software arrangements is generally recognized over the term of the contract, rather than at a point in time, and may differ in timing and pattern from revenue recognized under on-premise software arrangements. While this transition has not had a material impact on our historical results to date, it is expected to affect the timing and mix of revenue recognition in future periods and as a result, we expect revenue to decline in the near-term as the transition progresses.

Software maintenance. Software maintenance includes technical support, updates, and upgrades related to our on-premise software licenses. Software maintenance revenue is recognized ratably over the term of the arrangement. Software maintenance activities are performed in connection with the use of our on-premise software, and may fluctuate from period to period.

Professional services. Professional services include training, technical setup, installation or assisting customers with modeling services, where we use our software to perform tasks such as virtual screening on behalf of our customers. These services are generally not related to the core functionality of our software and are recognized as revenue when resources are consumed. Since each professional services agreement represents a unique, ad hoc engagement, professional services revenue may fluctuate from period to period.

Drug Discovery Revenue

We generate drug discovery revenue through the performance of specified research and development activities under our collaboration agreements and upon the achievement of discovery and development milestones, and we have the potential to generate drug discovery revenue from commercial and regulatory milestones, option fees, and royalties under our collaboration agreements. The majority of our current collaborations are in the discovery and preclinical development stages. Milestone payments typically increase in magnitude as a program advances. In addition to revenue from our collaborations, we may also derive drug discovery revenue from out-licensing our proprietary drug discovery programs when we believe it will help maximize the development, clinical and commercial potential of the program. Beyond our planned investments to complete our ongoing Phase 1 dose-escalation clinical trials of SGR-1505 and SGR-3515, we do not intend to initiate additional clinical trials or advance our other proprietary preclinical programs into clinical trials independently. Overall, we expect that our drug discovery revenue will fluctuate from period to period due to the inherently uncertain nature of the timing of milestone achievements and our dependence on the program decisions of our collaborators.

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Contribution Revenue

Software contribution revenue. Software contribution revenue consists of funds received under non-reciprocal agreements, as amended, with Gates Ventures, LLC and the Bill & Melinda Gates Foundation. The agreement with Gates Ventures, LLC was originally entered into in June 2020 and further extended through August 13, 2026. The agreement is an unconditional non-exchange contribution without restrictions. Revenue is recognized annually, when invoiced, in accordance with Accounting Standard Codification, or ASC, Topic 958, Not-for-Profit Entities, or Topic 958, as the agreement is not an exchange transaction.

In July 2024, we entered into a one-year agreement with the Bill & Melinda Gates Foundation, which was subsequently extended through April 2026, to initially fund our initiative to accelerate the expansion of our computational platform to predict toxicity associated with binding to off-target proteins. Revenue is recognized as costs are incurred and conditions are met in accordance with Topic 958.

Drug discovery contribution revenue. Contribution revenue primarily consists of funds received under agreements with the Bill & Melinda Gates Foundation on a cost reimbursement basis, to perform services aimed at accelerating drug discovery in women’s health. Revenue is recognized as costs are incurred and conditions are met in accordance with Topic 958.

Cost of Revenues

Software products and services. Cost of revenues for software includes personnel-related expenses (comprised of salaries, benefits, and stock-based compensation) for employees directly involved in the delivery of software solutions, maintenance and professional services, royalties paid for products sold and services performed using third-party licensed software functionality, and allocated overhead (facilities and information technology support) costs. Pursuant to various third-party arrangements, we license technology that is used in our software. These arrangements require us to pay royalties based on sales volume.

Drug discovery. Cost of revenues for drug discovery includes personnel-related expenses and costs of third-party contract research organizations, or CROs, that support discovery activities in our collaborations, royalties paid for services performed using third-party licensed software functionality, allocated compute capacity and overhead costs. While we have incurred costs associated with discovery efforts since late 2017, we have recognized and expect to continue to recognize revenues in the future if and when milestones are considered probable of achievement and there is not a risk of significant revenue reversal, or when they are achieved. Generally, drug discovery cost of revenues for collaborations are incurred in advance of the revenue milestone achievement. We expect our drug discovery cost of revenues to fluctuate from period to period depending on the number and mix of collaborative and proprietary programs and their respective stages of development.

Contribution. Cost of revenues for contribution includes personnel-related expenses, costs of third-party contract research organizations that support software development and drug discovery activities under our non-reciprocal agreements with the Bill & Melinda Gates Foundation, and allocated compute capacity. Contribution cost of revenues are recorded as costs are incurred under the agreements. We expect our contribution cost of revenues to fluctuate from period to period depending on the timing and progress of work completed.

Gross Profit and Gross Margin

Gross profit represents revenue less cost of revenues. Gross margin is gross profit expressed as a percentage of revenue. Our software products and services gross margin may fluctuate from period to period as our revenue fluctuates, and as a result of changes in sales mix between on-premise and hosted software solutions due to timing of recognition. For example, the cost of royalties due for sales of our hosted software arrangements are recognized upfront, whereas the associated hosted software revenue for these arrangements is recognized over the term of the underlying agreement.

While the gross margin of our drug discovery business will fluctuate significantly from period to period depending on factors such as the timing of recognition of milestones, the number and mix of collaborative programs, and their respective stages of development, we expect the gross margins to generally trend higher over time as more programs advance to later stages of development, the milestones increase in size and our ongoing research and development obligations to such programs decline in cost.

We expect contribution gross margin to approximate breakeven over time as revenue is recognized as costs are incurred and conditions are met.

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Research and Development Expense

Research and development expense accounts for a significant portion of our operating expenses. We recognize research and development expense as incurred. Research and development expense consists of drug discovery and development program costs and costs incurred for continuous development of the technology and science that supports our computational platform, primarily:

• personnel-related expenses, including salaries, benefits, bonuses, and stock-based compensation for employees engaged in research and development functions;

• expenses incurred under agreements with third-party CROs and consultants involved in our proprietary drug discovery programs; and

• allocated compute capacity on our proprietary drug discovery programs and overhead (facilities and information technology support) costs.

We expect our research and development expense to stabilize in regards to our investment in activities related to discovery and development of our proprietary drug discovery programs, in advancing our computational platform, and in hiring additional personnel directly involved in such efforts. The amount to which our research and development expense may fluctuate in the future will also be dependent on our development plans for our proprietary drug discovery programs, including the timing of any partnering, collaboration or out-licensing decisions. At this time, we do not know, nor can we reasonably estimate, the nature, timing, or costs of the efforts that will be necessary to complete the development of any of our proprietary drug discovery programs.

Sales and Marketing Expense

Sales and marketing expense consists primarily of personnel-related costs for our sales and marketing staff and application scientists supporting our sales efforts, including salaries, benefits, bonuses, and stock-based compensation. Other sales and marketing costs include promotional events that promote and expand knowledge of our company and platform, including industry conferences and events and our annual user group meetings in the United States and Europe, advertising, and allocated overhead costs. Due to the inherent scientific complexity of our software solutions, a high level of scientific expertise is needed to support our sales and marketing efforts. We plan to make focused investments in sales and marketing over the foreseeable future to foster the growth of our business as we aim to expand software sales to existing customers and increase our customer base.

General and Administrative Expense

General and administrative expense consists of personnel-related expenses associated with our executive, legal, finance, human resources, information technology, and other administrative functions, including salaries, benefits, bonuses, and stock-based compensation. General and administrative expense also includes professional fees for external legal, accounting and other consulting services, allocated overhead costs, and other general operating expenses.

We expect to continue to incur additional expenses as a result of operating as a public company, including costs to comply with the rules and regulations applicable to companies listed on a U.S. securities exchange and costs related to compliance and reporting obligations pursuant to the rules and regulations of the Securities and Exchange Commission, or SEC. In addition, as a public company, we expect to continue to incur increased expenses such as insurance and professional services. As a result, we expect the dollar amount of our general and administrative expense to increase for the foreseeable future.

Change in Fair Value of Equity Investments

Fair value gains and losses consist of adjustments to the fair value of our equity investments, which may include Nimbus and Structure Therapeutics. We remeasure our investments at each period end.

Fair value gains and losses may fluctuate significantly in future periods.

Other Income

Other income consists of interest earned on our cash equivalents and marketable securities, interest expense, and transactional foreign exchange gains and losses.

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Income Tax Expense

Income tax expense consists of U.S. federal and state income taxes and income taxes in certain foreign jurisdictions in which we conduct business. We maintain a full valuation allowance on our federal and state deferred tax assets as we have concluded that it is not more likely than not that the deferred tax assets will be realized.

Results of Operations

Comparison of the Three Months Ended March 31, 2026 and 2025

The following table summarizes our unaudited results of operations data for the three months ended March 31, 2026 and 2025:

Three Months Ended March 31, Change

2026 2025 $ %

(in thousands)

Revenues:

Software products and services $ 35,560  $ 44,972  $ (9,412) (21)%

Drug discovery 22,879  10,236  12,643  124%

Contribution 148  4,343  (4,195) (97)%

Total revenues 58,587  59,551  (964) (2)%

Cost of revenues:

Software products and services 10,863  9,112  1,751  19%

Drug discovery 16,310  14,452  1,858  13%

Contribution 1,867  4,863  (2,996) (62)%

Total cost of revenues 29,040  28,427  613  2%

Gross profit 29,547  31,124  (1,577) (5)%

Operating expenses:

Research and development 43,824  45,844  (2,020) (4)%

Sales and marketing 11,603  10,367  1,236  12%

General and administrative 22,914  25,802  (2,888) (11)%

Total operating expenses 78,341  82,013  (3,672) (4)%

Loss from operations (48,794) (50,889) 2,095  (4)%

Other (expense) income:

Change in fair value of equity investments (13,487) (13,095) (392) N/M

Other income 2,663  4,204  (1,541) N/M

Total other expense (10,824) (8,891) (1,933) N/M

Loss before income taxes (59,618) (59,780) 162  N/M

Income tax expense 408  28  380  N/M

Net loss $ (60,026) $ (59,808) $ (218) N/M

N/M – not meaningful

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Revenues

Three Months Ended March 31, Change

2026 2025 $ %

(in thousands)

Revenues:

Software

On-premise software $ 14,180  $ 25,423  $ (11,243) (44)%

Hosted software 12,080  10,872  1,208  11%

Software maintenance 6,662  6,796  (134) (2)%

Professional services 2,638  1,881  757  40%

Total software revenue 35,560  44,972  (9,412) (21)%

Drug discovery 22,879  10,236  12,643  124%

Contribution

Software contribution —  3,844  (3,844) (100)%

Drug discovery contribution 148  499  (351) (70)%

Total contribution revenue 148  4,343  (4,195) (97)%

Total revenues $ 58,587  $ 59,551  $ (964) (2)%

Software Products and Services Revenue

On-premise software. The decrease in revenues for on-premise software for the three months ended March 31, 2026 as compared to the three months ended March 31, 2025 was primarily attributable to the timing and size of multi-year customer contracts with upfront revenue recognition in the comparable period versus the current period, as well as customers switching from on-premise to hosted software purchases.

Hosted software. The increase in revenues for hosted software for the three months ended March 31, 2026 as compared to the three months ended March 31, 2025 was primarily due to customers switching from on-premise to hosted software purchases, as well as increased spend from existing hosted customers and growth in new customers purchasing hosted software subscriptions, for which revenue is recognized ratably over the period of the contract.

Software maintenance. The decrease in revenues for software maintenance for the three months ended March 31, 2026 as compared to the three months ended March 31, 2025 was primarily due to customers switching from on premise to hosted software purchases.

Professional services. The increase in revenues from professional services for the three months ended March 31, 2026 as compared to the three months ended March 31, 2025 was primarily related to fluctuations in the timing of progress and completion of technology and modeling service projects.

Drug Discovery Revenue

The increase in revenues for drug discovery services for the three months ended March 31, 2026 as compared to the three months ended March 31, 2025 was primarily due to Lilly's election not to proceed with further development for one program under the collaboration, which resulted in increased revenue recognition due to the accelerated completion of our obligations related to such program, and the progress of existing collaborations.

Contribution Revenue

Software contribution revenue. The decrease in revenues from software contribution during the three months ended March 31, 2026 as compared to the three months ended March 31, 2025 was due to a decrease in funds spent during the period as a result of depletion of allocated funds under the agreements with the Bill & Melinda Gates Foundation aimed at accelerating the expansion of our computational software platform during 2025.

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Drug discovery contribution revenue. The decrease in drug discovery contribution revenue for the three months ended March 31, 2026 as compared to the three months ended March 31, 2025 was primarily due to a decrease in funds spent during the period as a result of depletion of allocated funds under an agreement with the Bill & Melinda Gates Foundation, aimed at accelerating drug discovery in women’s health.

Cost of Revenues

Three Months Ended March 31, Change

2026 2025 $ %

(in thousands)

Cost of revenues:

Software products and services $ 10,863  $ 9,112  $ 1,751  19%

Gross margin 69  % 80  %

Drug discovery 16,310  14,452  1,858  13%

Contribution 1,867  4,863  (2,996) (62)%

Software products and services. The increase in cost of revenues for software products and services during the three months ended March 31, 2026 compared to the three months ended March 31, 2025 was attributable to increases of approximately $1.4 million in cloud computing expense, approximately $0.3 million in personnel-related expense, and approximately $0.1 million in other expenses.

Software products and services gross margin. Software gross margin decreased during the three months ended March 31, 2026 compared to the three months ended March 31, 2025 primarily due to a decrease in software revenue and an increase in expenses.

Drug discovery. The increase in cost of revenues for drug discovery during the three months ended March 31, 2026 compared to the three months ended March 31, 2025 was attributable to increases of approximately $2.6 million in CRO expense and approximately $0.2 million in royalty expense, partially offset by decreases of approximately $0.6 million in cloud computing expense and approximately $0.3 million in other expenses.

Contribution. The decrease in cost of revenues for contribution during the three months ended March 31, 2026 compared to the three months ended March 31, 2025 was attributable to decreases of approximately $1.9 million in personnel-related expense and approximately $1.3 million in cloud computing expense, partially offset by an increase of approximately $0.2 million in CRO expense.

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Research and Development Expense

A significant portion of our research and development costs have been external preclinical and clinical CRO costs, which we track on a program-by-program basis related to a product candidate, once the candidate has been identified. Our internal research and development costs are primarily personnel-related costs, rent expense, and other indirect costs and are not tracked on a program-by-program basis. All other research and development costs are related to non-program related costs. The following table summarizes our research and development expense for the three months ended March 31, 2026 and 2025:

Three Months Ended March 31, Change

2026 2025 $ %

(in thousands)

External costs by program:

SGR-1505 $ 1,761  $ 3,820  $ (2,059) (54)%

SGR-2921 (1)

68  2,379  (2,311) (97)%

SGR-3515 1,497  1,649  (152) (9)%

Other early development candidates and unallocated costs 6,385  4,861  1,524  31%

Total external costs for programs in preclinical and clinical development 9,711 12,709 (2,998) (24)%

Internal costs for discovery, preclinical and clinical development:

Employee compensation and benefits 8,655 8,773 (118) (1)%

Facility and other 496 532 (36) (7)%

Total internal costs 9,151 9,305 (154) (2)%

All other research and development 24,962 23,830 1,132  5%

Total research and development expense $ 43,824  $ 45,844  $ (2,020) (4)%

(1) The development of SGR-2921 was discontinued in August 2025.

The decrease in external costs of $3.0 million during the three months ended March 31, 2026 as compared to the three months ended March 31, 2025 was primarily attributable to a decrease in external research costs related to the discontinuation of the clinical development program for SGR-2921, as well as decreases in external research costs for SGR-1505 and SGR-3515 due to the timing of work performed, partially offset by higher costs for our early-stage product candidates.

The decrease in internal costs for programs in discovery, preclinical and clinical development of $0.2 million during the three months ended March 31, 2026 as compared to the three months ended March 31, 2025 was primarily attributable to a decrease in personnel-related expense.

The increase in all other research and development expense of $1.1 million during the three months ended March 31, 2026 as compared to the three months ended March 31, 2025 was attributable to increases of approximately $1.0 million in personnel-related expense and approximately $0.5 million in cloud computing expense, partially offset by decreases of approximately $0.2 million related to professional services, approximately $0.1 million related to office facilities, and approximately $0.1 million in travel and entertainment expenses.

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Sales and Marketing Expense

Three Months Ended March 31, Change

2026 2025 $ %

(in thousands)

Sales and marketing $ 11,603  $ 10,367  $ 1,236  12%

The increase in sales and marketing expense during the three months ended March 31, 2026 compared to the three months ended March 31, 2025 was primarily attributable to increases of approximately $0.5 million in travel and entertainment expense, approximately $0.5 million in personnel-related expense, approximately $0.1 million in cloud computing expense, and approximately $0.1 million in other expenses.

General and Administrative Expense

Three Months Ended March 31, Change

2026 2025 $ %

(in thousands)

General and administrative $ 22,914  $ 25,802  $ (2,888) (11)%

The decrease in general and administrative expense during the three months ended March 31, 2026 compared to the three months ended March 31, 2025 was attributable to decreases of approximately $1.8 million in personnel-related expense, approximately $0.5 million in professional services expense, approximately $0.4 million in other expenses, and approximately $0.2 million in travel and entertainment expense.

Change in Fair Value of Equity Investments

Three Months Ended March 31,

2026 2025 Change

(in thousands)

Change in fair value of equity investments $ (13,487) $ (13,095) $ (392)

The change in fair value of equity investments during the three months ended March 31, 2026 was due to an unrealized loss on our investment in Structure Therapeutics of $13.5 million. This consisted of a mark-to-market loss of approximately $14.5 million on the portion of the investment held as of March 31, 2026, partially offset by a mark-to-market gain of approximately $1.1 million on the portion of the investment sold during the period. The change in fair value of equity investments during the three months ended March 31, 2025 was due to an unrealized loss of $13.1 million on our investment in Structure Therapeutics.

Other Income

Three Months Ended March 31,

2026 2025 Change

(in thousands)

Other income $ 2,663  $ 4,204  $ (1,541)

The decrease in other income during the three months ended March 31, 2026 compared to the three months ended March 31, 2025 was attributable to unfavorable currency fluctuations of approximately $1.0 million and a decrease of approximately $0.5 million of interest income related to our investment portfolio.

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Income Tax Expense

Three Months Ended March 31,

2026 2025 Change

(in thousands)

Income tax expense $ 408  $ 28  $ 380

During the three months ended March 31, 2026 and 2025, we continued to recognize a full valuation allowance on our U.S. federal and state tax assets. Our income tax expense primarily represents our income tax obligations in certain states and taxes in foreign jurisdictions in which we conduct business.

Critical Accounting Estimates

Detailed information about our critical accounting estimates is set forth in Part II, Item 7 of our Annual Report on Form 10-K for the year ended December 31, 2025, which was filed with the SEC on February 25, 2026. There were no material changes to our critical accounting estimates during the three months ended March 31, 2026.

Liquidity, Capital Resources and Funding Requirements

We have a history of significant operating losses and have primarily incurred negative cash flows from operations from inception through the three months ended March 31, 2026. As of March 31, 2026, we had an accumulated deficit of $688.8 million.

We have funded our operations to date from the sale of our equity securities, including our initial public offering and our follow-on public offering, from sales of our software solutions and from upfront payments, research funding and milestone payments from our drug discovery collaborations, and from distributions on account of, or proceeds from the sale of, our equity stakes in our collaborators. Our operating cash flows are impacted by the magnitude and timing of our software sales and by the magnitude and timing of our drug discovery milestone achievements and research funding fees.

On February 28, 2024, we filed a universal shelf registration statement on Form S-3 which allows us to offer and sell an indeterminate number of shares of common stock, preferred stock, depositary shares or warrants, or an indeterminate principal amount of debt securities, from time to time pursuant to one or more offerings at prices and terms to be determined at the time of the sale.

In February 2024, we entered into an amended and restated sales agreement with Leerink Partners LLC, or Leerink Partners, as sales agent, with respect to an at-the-market offering program, or the ATM, under which we could offer and sell, from time to time pursuant to our Registration Statement on Form S-3, shares of common stock, having an aggregate offering price of up to $250.0 million through Leerink Partners. The amended and restated sales agreement amends and restates the original sales agreement that we entered into with Leerink Partners with respect to the ATM in May 2023, which is no longer in effect. No shares of common stock were sold under the ATM during the three months ended March 31, 2026 and 2025. As of March 31, 2026, we had $241.1 million of common stock remaining available for sale under the ATM.

As of March 31, 2026, we had cash, cash equivalents, restricted cash, and marketable securities of $406.4 million.

We believe our existing cash, cash equivalents, and marketable securities as of March 31, 2026 will be sufficient to fund our operating expenses and capital expenditure requirements through at least the next 24 months. Our future capital requirements will depend on many factors, including the growth of our software revenue, the timing and extent of spending to support research and development efforts, the continued expansion of software sales and marketing activities, the timing and receipt of milestone payments from our collaborations, as well as spending to support, advance, and broaden our proprietary drug discovery programs, including the impact of tariffs and trade restrictions on such spending. Furthermore, our capital requirements will also change depending on the timing and receipt of any distributions we may receive from our equity stakes in our drug discovery collaborators. The potential for these distributions, and the amounts which we may be entitled to receive, are difficult to predict due to the inherent uncertainty of the events which may trigger such distributions.

We plan to utilize the existing cash, cash equivalents, and marketable securities on hand primarily to fund our software and drug discovery activities. With respect to our proprietary drug discovery programs, we plan to strategically

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evaluate on a program-by-program basis advancing them into and through preclinical development ourselves, entering into collaborations to co-develop them with leading industry partners, or out-licensing them to maximize their development, clinical and commercial potential. Beyond our planned investments to complete our ongoing Phase 1 dose-escalation clinical trials of SGR-1505 and SGR-3515, we do not intend to initiate additional clinical trials or advance our other proprietary preclinical programs into clinical trials independently. We plan to explore strategic partnerships for the SGR-1505 and SGR-3515 programs to advance the development of these programs beyond our ongoing Phase 1 clinical trials.

We may be required to seek additional equity or debt financing. In the event that we require additional financing, we may not be able to raise such financing on terms acceptable to us or at all. If we are unable to raise additional capital or generate cash flows necessary to maintain or expand our operations and invest in our platform, we may not be able to compete successfully, which would harm our business, operations and financial condition. In addition, we may seek additional capital due to favorable market conditions or strategic considerations, even if we believe we have sufficient funds for our current or future operating plans.

Our contractual obligations as of March 31, 2026 include lease obligations of $155.8 million, consisting of our continuing rent obligations through December 2037, primarily for our office located in New York, New York for $124.1 million, which expires in December 2037. In addition, see Note 5, “Commitments and Contingencies” to our unaudited condensed consolidated financial statements for information relating to our operating lease obligations.

In December 2022, we entered into an agreement with a third-party to establish an exclusive integrated drug discovery dedicated facility in Hyderabad, India. The agreement contains a minimum payment obligation, which totals $21.8 million over five years after the date of first occupancy.

In December 2025, we entered into a three-year agreement with a third-party cloud provider for compute power. The agreement contains a minimum payment obligation, which totals $82.0 million over the three years after the date we entered into the agreement.

We also enter into agreements in the normal course of business with CRO vendors for research, preclinical studies, and clinical trials, professional consultants for expert advice, and other vendors for various products and services. These contracts do not contain any minimum purchase commitments and are cancellable at any time by us, generally upon 30 days prior written notice, and therefore we believe that our non-cancelable obligations under these agreements are not material. We have also agreed to pay volume-based royalties to third-parties for use of software functionality under various licensing and related agreements. See Note 2, "Significant Accounting Policies" to our audited consolidated financial statements appearing in Item 8 of our Annual Report on Form 10-K for the year ended December 31, 2025 for more information relating to our royalty obligations.

Cash Flows

The following table presents a summary of our cash flows for the periods shown:

Three Months Ended March 31,

2026 2025

(in thousands)

Net cash (used in) provided by operating activities $ (14,834) $ 144,063

Net cash provided by investing activities 44,599  30,632

Net cash provided by financing activities 569  409

Net increase in cash and cash equivalents and restricted cash $ 30,334  $ 175,104

Operating activities

During the three months ended March 31, 2026, operating activities used approximately $14.8 million of cash, primarily due to a net loss of $60.0 million. This net loss was partially offset by changes to our operating assets and liabilities of $21.8 million, $13.5 million of non-cash loss on change in fair value of equity investments, $9.1 million of stock-based compensation, and $0.8 million of non-cash operating expenses, depreciation, and investment accretion costs.

During the three months ended March 31, 2025, operating activities provided approximately $144.1 million of cash, primarily due to changes to our operating assets and liabilities of $178.5 million, a $13.1 million non-cash loss on

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change in fair value of equity investments, $11.6 million of stock-based compensation, and $0.7 million of non-cash operating expenses, depreciation and investment accretion costs. These items were partially offset by a net loss of $59.8 million.

Investing activities

During the three months ended March 31, 2026, investing activities provided approximately $44.6 million of cash, consisting of $26.8 million from marketable securities maturities, net of purchases, and $20.3 million from the sale of equity investments. These items were partially offset by $2.5 million in cash used for purchases of property and equipment.

During the three months ended March 31, 2025, investing activities provided approximately $30.6 million of cash, consisting of $31.2 million provided by marketable securities maturities, net of purchases. These items were partially offset by $0.6 million in cash used for purchases of property and equipment.

Financing activities

During the three months ended March 31, 2026, financing activities provided approximately $0.6 million of cash, primarily attributable to proceeds received upon stock option exercises.

During the three months ended March 31, 2025, financing activities provided approximately $ 0.4 million of cash, primarily attributable to proceeds received upon stock option exercises.

Item 3. Quantitative and Qualitative Disclosures About Market Risk.

There have been no material changes in our reported market risks or risk management policies since the filing of our Annual Report on Form 10-K for the fiscal year ended December 31, 2025, which was filed with the Securities and Exchange Commission on February 25, 2026.

Item 4. Controls and Procedures.

Evaluation of Disclosure Controls and Procedures

Our management, with the participation of our principal executive officer and principal financial officer, has evaluated the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended, or the Exchange Act), as of March 31, 2026. The term “disclosure controls and procedures,” means controls and other procedures of a company that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the Securities and Exchange Commission’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the company’s management, including its principal executive and principal financial officers, or persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure. Management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Based on such evaluation of our disclosure controls and procedures as of March 31, 2026, our principal executive officer and principal financial officer have concluded that as of such date, our disclosure controls and procedures were effective at the reasonable assurance level.

Changes in Internal Control Over Financial Reporting

There has been no change in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) that occurred during the period covered by this report that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

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PART II—OTHER INFORMATION

Item 1. Legal Proceedings.

We are not currently subject to any material legal proceedings.

Item 1A. Risk Factors.

You should carefully consider the risks and uncertainties described below together with all of the other information contained in this Quarterly Report and our other public filings with the SEC. The risks described below are not the only risks facing our company. The occurrence of any of the following risks, or of additional risks and uncertainties not presently known to us or that we currently believe to be immaterial, could cause our business, prospects, operating results, and financial condition to suffer materially.

Risks Related to Our Financial Position and Need for Additional Capital

We have a history of significant operating losses, and we expect to incur losses over the next several years.

We have a history of significant operating losses. Our net loss for the three months ended March 31, 2026 and 2025 was $60.0 million and $59.8 million, respectively. Our net loss for the years ended December 31, 2025 and 2024 was $103.3 million and $187.1 million, respectively. As of March 31, 2026, we had an accumulated deficit of $688.8 million.

Our operating expenses may increase as we continue to invest in our computational platform, sales and marketing infrastructure, and proprietary drug discovery programs. We are still in the early stages of development of our own proprietary drug discovery programs. We have no drug products approved or licensed for commercial sale, and as such, have not generated any revenue from our own drug product sales to date. We expect to continue to incur significant expenses and operating losses over the next several years. Our operating expenses and net income or loss may fluctuate significantly from quarter to quarter and year to year and you should not rely upon the results of any quarterly or annual periods as indications of future results. Our expenses could increase if and as we:

• continue to invest in and develop our computational platform and software solutions;

• continue our research and development efforts for our proprietary drug discovery programs;

• conduct preclinical studies for any of our product candidates and complete our ongoing Phase 1 dose-escalation clinical trials for SGR-1505 and SGR-3515;

• prepare and make regulatory submissions for any of our product candidates;

• maintain, expand, enforce, defend, and protect our intellectual property;

• hire additional software engineers, programmers, sales and marketing, and other personnel to support our software business and other commercial operations;

• hire additional scientific personnel; and

• add operational, financial, and management information systems and personnel to support our operations as a public company.

If we are unable to increase sales of our software, increase revenue from our drug discovery collaborations, or if we and our current and future collaborators are unable to successfully develop and commercialize drug products, our revenues may be insufficient for us to achieve or maintain profitability.

To achieve and maintain profitability, we must succeed in significantly increasing our software sales and increasing revenue from our drug discovery collaborations, or we and our current or future collaborators must succeed in developing, and eventually commercializing, a drug product or drug products that generate significant revenue. We currently generate revenues from the sales of our software solutions and from achieving milestones under our collaborative drug discovery programs, and we expect to continue to derive most of our revenue from sales of our software and from achieving such milestones until such time as our or our collaborators’ drug development and commercialization efforts are successful, if ever. As such, increasing sales of our software to existing customers, successfully marketing our software to new customers, and achieving milestones under our drug discovery collaborations are critical to our success. Demand for our software solutions may be affected by a number of factors, including continued market acceptance by the biopharmaceutical industry, market adoption of our software solutions beyond the biopharmaceutical industry including for

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materials science applications, the ability of our platform to identify more promising molecules and accelerate and lower the costs of discovery as compared to traditional methods, timing of development and release of new offerings by our competitors, technological change, and the rate of growth in our target markets. If we are unable to continue to meet the demands of our customers, our business operations, financial results, and growth prospects will be adversely affected.

Achieving success in drug development will require us or our current or future collaborators to be effective in a range of challenging activities, including completing preclinical testing and clinical trials of product candidates, obtaining regulatory approval for these product candidates and manufacturing, marketing, and selling any products for which we or they may obtain regulatory approval. We are only in the early stages of most of these activities, and none of our current drug discovery collaborators have completed clinical development of any product candidate. We and our drug discovery collaborators may never succeed in these activities and, even if we do, we may never generate revenues that are significant enough to achieve and sustain profitability, or even if our collaborators do, we may not receive option fees, milestone payments, or royalties from them that are significant enough for us to achieve and sustain profitability. Because of the intense competition in the market for our software solutions and the numerous risks and uncertainties associated with biopharmaceutical product development, we are unable to accurately predict when, or if, we will be able to achieve or sustain profitability.

Even if we achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis. Our failure to become and remain profitable would depress the value of our company and could impair our ability to raise capital, expand our business, maintain our research and development efforts, increase sales of our software, develop a pipeline of product candidates, enter into collaborations, or even continue our operations. A decline in the value of our company could also cause our stockholders to lose all or part of their investment.

Our revenue has and may continue to fluctuate from quarter-to-quarter and year-to-year. For example, our total revenues decreased by 2% from $59.6 million in the three months ended March 31, 2025 to $58.6 million in the three months ended March 31, 2026, and increased by 23% from $207.5 million in the fiscal year ended December 31, 2024 to $255.9 million in the fiscal year ended December 31, 2025. Although we have experienced revenue growth in certain periods, we have also experienced a decline in revenue in certain periods, and we may not be able to sustain revenue growth and we may experience certain periods of revenue decline. In addition, we have accelerated our efforts to transition customers from on-premise software arrangements to hosted software contracts. As a result of this transition, we expect future quarterly and annual revenue trends to be impacted, as revenue associated with hosted software arrangements is generally recognized over the term of the contract, rather than at a point in time, and may differ in timing and pattern from revenue recognized under on-premise software arrangements. This transition is expected to affect the timing and mix of revenue recognition in future periods and as a result, we expect revenue to decline in the near-term as the transition progresses. You should not consider our revenue growth in prior periods as indicative of our future performance. As we grow our business, our revenue growth rates may slow in future periods.

Our quarterly and annual results may fluctuate significantly, which could adversely impact the value of our common stock.

Our results of operations, including our revenues, gross margin, profitability, and cash flows, have historically varied from period to period, and we expect that they will continue to do so. As a result, period-to-period comparisons of our operating results may not be meaningful, and our quarterly and annual results should not be relied upon as an indication of future performance. Our quarterly and annual financial results may fluctuate as a result of a variety of factors, many of which are outside of our control. Factors that may cause fluctuations in our quarterly and annual financial results include, without limitation, those listed elsewhere in this "Risk Factors" section and those listed below:

• customer renewal rates and the timing and terms of customer renewals, including the seasonality of customer renewals of our on-premise software arrangements, for which revenue historically has been recognized at a single point in time in the first and fourth quarter of each fiscal year;

• our ability to attract new customers for our software;

• the addition or loss of large customers, including through acquisitions or consolidations of such customers;

• the amount and timing of operating expenses related to the maintenance and expansion of our business, operations, and infrastructure;

• network outages or security breaches;

• industry and market conditions, including within the life sciences industry;

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• general economic conditions, including the impact of increasing or decreasing inflation and interest rates and the impact of tariffs and trade restrictions;

• our ability to collect receivables from our customers;

• the amount of software purchased by our customers, including the mix of on-premise and hosted software sold during a period;

• variations in the timing of the sales of our software, which may be difficult to predict;

• changes in the pricing of our solutions and in our pricing policies or those of our competitors;

• the timing and success of the introduction of new software solutions by us or our competitors or any other change in the competitive dynamics of our industry, including consolidation among competitors, customers, or strategic collaborators;

• changes in the fair value of or receipt of distributions or proceeds on account of the equity interests we hold in our drug discovery collaborators, such as Structure Therapeutics and Nimbus;

• the success of our drug discovery collaborators in developing and commercializing drug products for which we are entitled to receive milestone payments or royalties;

• the timing of the recognition of milestones achieved under our collaborative programs;

• variations in the number and size of milestones achieved under our collaborative programs;

• the timing of recognition of revenue from any payments from entering into collaborations or out-licensing our proprietary drug discovery programs, such as under our collaboration agreement with Novartis Pharma AG, or Novartis; and

• the timing of expenses related to our drug discovery programs, the development or acquisition of technologies or businesses and potential future charges for impairment of goodwill from acquired companies.

In addition, because we recognize revenues from our hosted software solutions ratably over the term of the agreement, a significant upturn or downturn in sales of our hosted software solutions may not be reflected immediately in our operating results. As a result of these factors, we believe that period-to-period comparisons of our operating results are not a good indication of our future performance and that our interim financial results are not necessarily indicative of results for a full year or for any subsequent interim period.

We will likely require additional capital to fund our operations. If we are unable to raise additional capital on terms acceptable to us or at all or generate cash flows necessary to maintain or expand our operations, we may not be able to compete successfully, which would harm our business, operations, and financial condition.

We expect to devote substantial financial resources to our ongoing and planned activities, including the development of drug discovery programs and continued investment in our computational platform. We expect our expenses to increase in connection with our ongoing and planned activities, particularly as we advance our proprietary drug discovery programs, initiate or progress preclinical and Investigational New Drug, or IND,-enabling studies, progress clinical trials and invest in the further development of our computational platform. In addition, though not our current strategy, if we decide to complete clinical development and seek regulatory approval on our own, we expect to incur significant additional expenses. Furthermore, we incur additional costs associated with operating as a public company, as compared to when we were a private company.

Our current drug discovery collaborators, from whom we are entitled to receive milestone payments upon achievement of various development, regulatory, and commercial milestones as well as royalties on commercial sales, if any, under the collaboration agreements that we have entered into with them, face numerous risks in the development of drugs, including the conduct of preclinical and clinical testing, obtaining regulatory approval, and achieving product sales. In addition, the amounts we are entitled to receive upon the achievement of such milestones tend to be smaller for near-term development milestones and increase if and as a collaborative product candidate advances through regulatory development to commercialization and will vary depending on the level of commercial success achieved, if any. We do not anticipate receiving significant milestone payments from many of our drug discovery collaborators for several years, if at all, and our drug discovery collaborators may never achieve milestones that would result in significant cash payments to us. In addition, while we have equity stakes in a number of our collaborators, the value of these equity stakes can vary significantly based on a number of factors beyond our control, and there can be no assurance that we can rely on such

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equity as capital to fund our operations. For these reasons we may need, or choose, to obtain additional capital to fund our continuing operations.

As of March 31, 2026, we had cash, cash equivalents, restricted cash, and marketable securities of $406.4 million. We believe that our existing cash, cash equivalents, and marketable securities as of March 31, 2026 will be sufficient to fund our operating expenses and capital expenditure requirements through at least the next 24 months. However, we have based this estimate on assumptions that may prove to be wrong, and our operating plans may change as a result of many factors currently unknown to us. As a result, we could deplete our capital resources sooner than we currently expect.

Our future capital requirements will depend on many factors, including:

• the growth of our software revenue;

• the timing and extent of spending to support research and development efforts;

• the continued expansion of software sales and marketing activities;

• the timing and receipt of payments from our drug discovery collaborations;

• spending to support, advance, and broaden our proprietary drug discovery programs, including the impact of tariffs and trade restrictions on such spending; and

• the timing and receipt of any distributions or proceeds we may receive from our equity stakes in our drug discovery collaborators.

In the event that we require additional financing, we may not be able to raise such financing on terms acceptable to us or at all. In addition, we may seek additional capital due to favorable market conditions or strategic considerations, even if we believe we have sufficient funds for our current or future operating plans. If we are unable to raise additional capital on terms acceptable to us or at all or generate cash flows necessary to maintain or expand our operations and invest in our computational platform, we may not be able to compete successfully, which would harm our business, operations, and financial condition.

Raising additional capital may cause dilution to our stockholders, restrict our operations, or require us to relinquish rights to our technologies or drug programs.

To the extent that we raise additional capital through the sale of equity or convertible debt securities, our stockholders’ ownership interests will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect our stockholders’ rights as common stockholders. Debt financing and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, selling or licensing our assets, making product acquisitions, making capital expenditures, or declaring dividends.

If we raise additional funds through collaborations, strategic alliances or marketing, distribution, or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs, or product candidates or grant licenses on terms that may not be favorable to us or agree to exploit a drug development target exclusively for one of our collaborators when we may prefer to pursue the drug development target for ourselves.

If our estimates, judgments or assumptions relating to our critical accounting policies prove to be incorrect or financial reporting standards or interpretations change, our results of operations could be adversely affected.

The preparation of financial statements in conformity with generally accepted accounting principles in the United States requires management to make judgments, estimates and assumptions that affect the amounts reported in the consolidated financial statements and accompanying notes. We base our estimates on historical experience, known trends and events, our beliefs of what could occur in the future considering available information and various other factors that we believe to be reasonable under the circumstances, as provided in Part II, Item 7. "Management’s Discussion and Analysis of Financial Condition and Results of Operations—Critical Accounting Policies and Estimates" of our Annual Report on Form 10-K for the year ended December 31, 2025. The results of these estimates form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Significant judgment, assumptions and estimates used in preparing our consolidated financial statements include, with respect to revenue, determining the allocation of the transaction price and measurement of progress, including (1) the constraint on variable

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consideration, (2) the identification of performance obligations and the allocation of the transaction price to the performance obligations using their standalone selling price basis, and (3) the appropriate input or output based method to recognize collaboration revenue and the extent of progress to date.

Our results of operations may be adversely affected if our assumptions change or if actual circumstances differ from those in our assumptions, which could cause our results of operations to fall below the expectations of securities analysts and investors, resulting in a decline in the trading price of our common stock.

Additionally, we regularly monitor our compliance with applicable financial reporting standards and review new pronouncements and drafts thereof that are relevant to us. As a result of new standards, changes to existing standards and changes in their interpretation, we might be required to change our accounting policies, alter our operational policies, and implement new or enhance existing systems so that they reflect new or amended financial reporting standards, or we may be required to restate our published financial statements. Such changes to existing standards or changes in their interpretation may have an adverse effect on our reputation, business, financial position, and profit.

Risks Related to Our Software

If our existing customers do not renew their licenses, do not buy additional solutions from us, or renew at lower prices, our business and operating results will suffer.

We expect to continue to derive a significant portion of our software revenues from renewal of existing license agreements. As a result, maintaining the renewal rate of our existing customers and selling additional software solutions to them is critical to our future operating results. Factors that may affect the renewal rate for our customers and our ability to sell additional solutions to them include:

• the price, performance, and functionality of our software solutions;

• the availability, price, performance, and functionality of competing software solutions;

• the effectiveness of our professional services;

• our ability to develop or acquire complementary software solutions, applications, and services;

• the success of competitive products or technologies;

• the stability, performance, and security of our technological infrastructure;

• the business environment of our customers;

• the willingness of our customers to continue to adopt computational approaches to drug discovery, which can be impacted by changes in our customer’s management and/or scientific personnel; and

• the decisions of our customers to discontinue or reduce the amount of drug discovery they undertake internally.

We deliver our software through either (i) a product license that permits our customers to install the software solution directly on their own in-house hardware and use it for a specified term, or (ii) a subscription that allows our customers to access the cloud-based software solution on their own hardware without taking control of the licenses. Our customers have no obligation to renew their product licenses or subscriptions for our software solutions after the license term expires, which is typically after one year, and many of our contracts may be terminated or reduced in scope either immediately or upon notice. In addition, our customers may negotiate terms less advantageous to us upon renewal, which may reduce our revenues from these customers. Factors that are not within our control may contribute to a reduction in our software revenues. For instance, our customers may reduce the number of their employees who are engaged in research and who would have use of our software, which would result in a corresponding reduction in the number of user licenses needed for some of our solutions and thus a lower aggregate renewal fee. The loss, reduction in scope, or delay of a large contract, or the loss or delay of multiple contracts, could materially adversely affect our business.

Our future operating results also depend, in part, on our ability to sell new software solutions and licenses to our existing customers. For example, the willingness of existing customers to license our software will depend on our ability to scale and adapt our existing software solutions to meet the performance and other requirements of our customers, which we may not do successfully. If our customers fail to renew their agreements, renew their agreements upon less favorable terms or at lower fee levels, or fail to purchase new software solutions and licenses from us, our revenues may decline and our future revenues may be negatively impacted.

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Our software sales cycle can vary and be long and unpredictable.

The timing of sales of our software solutions is difficult to forecast because of the length and unpredictability of our sales cycle. We sell our solutions primarily to biopharmaceutical companies, and our sales cycles can be as long as nine to twelve months or longer. Further, the length of time that potential customers devote to their testing and evaluation, contract negotiation, and budgeting processes varies significantly, depending on the size of the organization and the nature of their needs. In addition, we might devote substantial time and effort to a particular unsuccessful sales effort, and as a result, we could lose other sales opportunities or incur expenses that are not offset by an increase in revenue, which could harm our business.

A significant portion of our revenues are generated by sales to life sciences industry customers, and factors that adversely affect this industry could adversely affect our software sales.

A significant portion of our current software sales are to customers in the life sciences industry, in particular the biopharmaceutical industry. Demand for our software solutions could be affected by factors that adversely affect the life sciences industry. The life sciences industry is highly regulated and competitive and has experienced periods of considerable consolidation. Consolidation among our customers could cause us to lose customers, decrease the available market for our solutions, and adversely affect our business. In addition, changes in regulations that make investment in the life sciences industry less attractive or drug development more expensive could adversely impact the demand for our software solutions. For these reasons and others, selling software to life sciences companies can be competitive, expensive, and time consuming, often requiring significant upfront time and expense without any assurance that we will successfully complete a software sale. Accordingly, our operating results and our ability to efficiently provide our solutions to life sciences companies and to grow or maintain our customer base could be adversely affected as a result of factors that affect the life sciences industry generally.

We also intend to continue leveraging our solutions for broad application to industrial challenges in molecule design, including in the fields of aerospace, energy, semiconductors, electronic displays and chemicals. However, we believe the materials science industry is in the very early stages of recognizing the potential of computational methods for molecular discovery, and there can be no assurance that the industry will adopt computational methods such as our platform. Any factor adversely affecting our ability to market our software solutions to customers outside of the life sciences industry, including in these new fields, could increase our dependence on the life sciences industry and adversely affect the growth rate of our revenues, operating results, and business.

The markets in which we participate are highly competitive, and if we do not compete effectively, our business and operating results could be adversely affected.

The overall market for molecular discovery and design software is global, rapidly evolving, competitive, and subject to changing technology and shifting customer interests and priorities. Our software solutions face competition from competitors in the business of selling or providing simulation and modeling software to biopharmaceutical companies. These competitors include BIOVIA, a brand of Dassault Systèmes SE, or BIOVIA, Chemical Computing Group (US) Inc., Cresset Biomolecular Discovery Limited, Cadence Design Systems, Inc., Optibrium Limited, Cyrus Biotechnology, Inc., Molsoft LLC, Insilico Medicine, Inc., Iktos, XtalPi Inc., AbCellera, Inductive Bio, Inc., Chemaxon, Revvity, Inc., and Simulations Plus, Inc.

We also have competitors in materials science, such as BIOVIA and Materials Design, Inc., and in enterprise software for the life sciences, such as BIOVIA, Certara USA, Inc., Chemaxon, Revvity, Inc., and Dotmatics, Inc. In some cases, these competitors are well-established providers of these solutions and have long-standing relationships with many of our current and potential customers, including large biopharmaceutical companies. In addition, there are academic consortia that develop physics-based simulation programs for life sciences and materials applications. In the life sciences industry, the most prominent academic simulation packages include AMBER, CHARMm, GROMACS, GROMOS, OpenMM, and OpenFF. These packages are primarily maintained and developed by graduate students and post-doctoral researchers, often without the intent of commercialization.

We also face competition from solutions that biopharmaceutical companies develop internally and from smaller companies that offer products and services directed at more specific markets than we target, enabling these smaller competitors to focus a greater proportion of their efforts and resources on these markets, as well as a large number of companies that have been founded with the goal of applying machine learning technologies to drug discovery.

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Many of our competitors are able to devote greater resources to the development, promotion, and sale of their software solutions and services. It is possible that our efforts in proprietary drug discovery will result in loss of management focus and resources relating to our software business, thereby resulting in decreasing revenues from our software business. Furthermore, third parties with greater available resources and the ability to initiate or withstand substantial price competition could acquire our current or potential competitors. Our competitors may also establish cooperative relationships among themselves or with third parties that may further enhance their product offerings or resources. If our competitors’ products, services, or technologies become more accepted than our solutions, if our competitors are successful in bringing their products or services to market earlier than ours, if our competitors are able to respond more quickly and effectively to new or changing opportunities, technologies, or customer requirements, or if their products or services are more technologically capable than ours, then our software revenues could be adversely affected.

In addition, we are facing increasing competition from companies utilizing artificial intelligence, or AI, and other computational approaches for drug discovery. Some of these competitors are involved in drug discovery themselves and/or with partners, and others develop software or other tools utilizing AI which can be used, directly or indirectly, in drug discovery. To the extent these other AI approaches to drug discovery prove to be successful, or more successful, than our approach, the demand for our platform could be adversely affected, which could affect our software demand as well as reduce the demand for us as a collaborator in drug discovery.

We may be required to decrease our prices or modify our pricing practices in order to attract new customers or retain existing customers due to increased competition. Pricing pressures and increased competition could result in reduced sales, reduced margins, losses, or a failure to maintain or improve our competitive market position, any of which could adversely affect our business.

We have invested and expect to continue to invest in research and development efforts that further enhance our computational platform. Such investments may affect our operating results, and, if the return on these investments is lower or develops more slowly than we expect, our revenue and operating results may suffer.

We have invested and expect to continue to invest in research and development efforts that further enhance our computational platform, often in response to our customers’ requirements. These investments may involve significant time, risks, and uncertainties, including the risk that the expenses associated with these investments may affect our margins and operating results and that such investments may not generate sufficient revenues to offset liabilities assumed and expenses associated with these new investments. The software industry changes rapidly as a result of technological and product developments, which may render our solutions less desirable. For example, in recent years, a number of companies have entered the drug discovery industry utilizing different AI approaches. While we believe we compete favorably and are meaningfully differentiated from such approaches with the combination of our physics-based computational platform and machine learning capabilities, the success of other such AI approaches to drug discovery could impact the demand for our solutions. We believe that we must continue to invest a significant amount of time and resources in our platform and software solutions to maintain and improve our competitive position. If we do not achieve the benefits anticipated from these investments, if the achievement of these benefits is delayed, if technological developments render our solutions less desirable, or if a slowdown in general computing power impacts the rate at which we expect our physics-based simulations to increase in power and domain applicability, our revenue and operating results may be adversely affected.

If we are unable to collect receivables from our customers, our operating results may be adversely affected.

While the majority of our current customers are well-established, large companies and universities, we also provide software solutions to smaller companies. Our financial success depends upon the creditworthiness and ultimate collection of amounts due from our customers, including our smaller customers with fewer financial resources. If we are not able to collect amounts due from our customers, we may be required to write-off significant accounts receivable and recognize bad debt expenses, which could materially and adversely affect our operating results.

Defects or disruptions in our solutions could result in diminishing demand for our solutions, a reduction in our revenues, and subject us to substantial liability.

Our software business and the level of customer acceptance of our software depend upon the continuous, effective, and reliable operation of our software and related tools and functions. Our software solutions are inherently complex and may contain defects or errors. Errors may result from our own technology or from the interface of our software solutions with legacy systems and data, which we did not develop. The risk of errors is particularly significant when a new software solution is first introduced or when new versions or enhancements of existing software solutions are

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released. We have from time to time found defects in our software, and new errors in our existing software may be detected in the future. Any errors, defects, disruptions, or other performance problems with our software could hurt our reputation and may damage our customers’ businesses. If that occurs, our customers may delay or withhold payment to us, cancel their agreements with us, elect not to renew, make service credit claims, warranty claims, or other claims against us, and as a result, we could lose future sales. The occurrence of any of these events could result in diminishing demand for our software, a reduction of our revenue, an increase in collection cycles for accounts receivable, require us to increase our warranty provisions, or incur the expense of litigation or substantial liability.

We rely upon third-party providers of cloud-based infrastructure to host our software solutions. Any disruption in the operations of these third-party providers, limitations on capacity, or interference with our use could adversely affect our business, financial condition, and results of operations.

We outsource substantially all of the infrastructure relating to our hosted software solutions to third-party hosting services. Customers of our hosted software solutions need to be able to access our computational platform at any time, without interruption or degradation of performance, and we provide them with service-level commitments with respect to uptime. Our hosted software solutions depend on protecting the virtual cloud infrastructure hosted by third-party hosting services by maintaining its configuration, architecture, features, and interconnection specifications, as well as the information stored in these virtual data centers, which is transmitted by third-party internet service providers. Any limitation on the capacity of our third-party hosting services could impede our ability to onboard new customers or expand the usage of our existing customers, which could adversely affect our business, financial condition, and results of operations. In addition, any incident affecting our third-party hosting services’ infrastructure that may be caused by cyber-attacks, natural disasters, fire, flood, severe storm, earthquake, power loss, telecommunications failures, terrorist or other attacks, and other similar events beyond our control could negatively affect our cloud-based solutions. A prolonged service disruption affecting our cloud-based solutions for any of the foregoing reasons would negatively impact our ability to serve our customers and could damage our reputation with current and potential customers, expose us to liability, cause us to lose customers, or otherwise harm our business. We may also incur significant costs for using alternative equipment or taking other actions in preparation for, or in reaction to, events that damage the third-party hosting services we use.

In the event that our service agreements with our third-party hosting services are terminated, or there is a lapse of service, elimination of services or features that we utilize, interruption of internet service provider connectivity, or damage to such facilities, we could experience interruptions in access to our platform as well as significant delays and additional expense in arranging or creating new facilities and services and/or re-architecting our hosted software solutions for deployment on a different cloud infrastructure service provider, which could adversely affect our business, financial condition, and results of operations.

If our security measures are breached or unauthorized access to customer data is otherwise obtained, our solutions may be perceived as not being secure, customers may reduce the use of or stop using our solutions, and we may incur significant liabilities.

Our solutions involve the collection, analysis, and storage of our customers’ proprietary information and sensitive proprietary data related to the discovery efforts of our customers. As a result, unauthorized access or security breaches, as a result of third-party action, employee error, malfeasance, or otherwise could result in the loss of information, litigation, indemnity obligations, damage to our reputation, and other liability. Because the techniques used to obtain unauthorized access or sabotage systems change frequently and generally are not identified until they are launched against a target, we may be unable to anticipate these techniques or to implement adequate preventative measures. In addition, if our employees fail to adhere to practices we have established to maintain a firewall between our drug discovery group, which we refer to as the Schrödinger therapeutics group, and our teams that work with software customers, or if the technical solutions we have adopted to maintain the firewall malfunction, our customers and collaborators may lose confidence in our ability to maintain the confidentiality of their intellectual property, we may have trouble attracting new customers and collaborators, we may be subject to breach of contract claims by our customers and collaborators, and we may suffer reputational and other harm as a result. Any or all of these issues could adversely affect our ability to attract new customers, cause existing customers to elect not to renew their licenses, result in reputational damage or subject us to third-party lawsuits or other action or liability, which could adversely affect our operating results. Our insurance may not be adequate to cover losses associated with such events, and in any case, such insurance may not cover all of the types of costs, expenses, and losses we could incur to respond to and remediate a security breach.

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Any failure to offer high-quality technical support services could adversely affect our relationships with our customers and our operating results.

Our customers depend on our support organization to resolve technical issues relating to our solutions, as our software requires expert usage to fully exploit its capabilities. Certain of our customers also rely on us to troubleshoot problems with the performance of the software, introduce new features requested for specific customer projects, inform them about the best way to set up and analyze various types of simulations and illustrate our techniques for drug discovery using examples from publicly available data sets. We may be unable to respond quickly enough to accommodate short-term increases in customer demand for these support services. Increased customer demand for our services, without corresponding revenues, could increase costs and adversely affect our operating results. In addition, our sales process is highly dependent on the reputation of our solutions and business and on positive recommendations from our existing customers. Any failure to offer high-quality technical support, or a market perception that we do not offer high-quality support, could adversely affect our reputation, our ability to sell our solutions to existing and prospective customers and our business and operating results.

Our solutions utilize third-party open-source software, and any failure to comply with the terms of one or more of these open-source software licenses could adversely affect our business or our ability to sell our software solutions, subject us to litigation, or create potential liability.

Our solutions include software licensed by third parties under any one or more open-source licenses, including the GNU General Public License, the GNU Lesser General Public License, the GNU Affero General Public License, the BSD License, the MIT License, the Apache License, and others, and we expect to continue to incorporate open-source software in our solutions in the future. Moreover, we cannot ensure that we have effectively monitored our use of open-source software or that we are in compliance with the terms of the applicable open-source licenses or our current policies and procedures. There have been claims against companies that use open-source software in their products and services asserting that the use of such open-source software infringes the claimants’ intellectual property rights. As a result, we and our customers could be subject to suits by third parties claiming that what we believe to be licensed open-source software infringes such third parties’ intellectual property rights, and we may be required to indemnify our customers against such claims. Additionally, if an author or other third party that distributes such open-source software were to allege that we had not complied with the conditions of one or more of these licenses, we or our customers could be required to incur significant legal expenses defending against such allegations and could be subject to significant damages, enjoined from the sale of our solutions that contain the open-source software and required to comply with onerous conditions or restrictions on these solutions, which could disrupt the distribution and sale of these solutions. Litigation could be costly for us to defend, have a negative effect on our business, financial condition, and results of operations, or require us to devote additional research and development resources to change our solutions.

Use of open-source software may entail greater risks than use of third-party commercial software, as open-source licensors generally do not provide warranties or other contractual protections regarding infringement claims or the quality of the code, including with respect to security vulnerabilities. In addition, certain open-source licenses require that source code for software programs that interact with such open-source software be made available to the public at no cost and that any modifications or derivative works to such open-source software continue to be licensed under the same terms as the open-source software license. The terms of various open-source licenses have not been interpreted by courts in the relevant jurisdictions, and there is a risk that such licenses could be construed in a manner that imposes unanticipated conditions or restrictions on our ability to market our solutions. By the terms of certain open-source licenses, we could be required to release the source code of our proprietary software, and to make our proprietary software available under open-source licenses, if we combine our proprietary software with open-source software in a certain manner. In the event that portions of our proprietary software are determined to be subject to an open-source license, we could be required to publicly release the affected portions of our source code, re-engineer all or a portion of our solutions, or otherwise be limited in the licensing of our solutions, each of which could reduce or eliminate the value of our solutions. Disclosing our proprietary source code could allow our competitors to create similar products with lower development effort and time and ultimately could result in a loss of sales. Any of these events could create liability for us and damage our reputation, which could have a material adverse effect on our revenue, business, results of operations, and financial condition and the market price of our shares.

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Risks Related to Drug Discovery

We may never realize a return on our investment of resources and cash in our drug discovery collaborations.

We use our computational platform to provide drug discovery services to collaborators who are engaged in drug discovery and development. These collaborators include start-up companies, pre-commercial biotechnology companies, and large-scale pharmaceutical companies. When we engage in drug discovery with these collaborators, we typically provide access to our platform and platform experts who assist the drug discovery collaborator in identifying molecules that have activity against one or more specified protein targets. We historically have not received significant initial cash consideration for these services, except for the upfront payment of $55.0 million we received from Bristol-Myers Squibb Company, or BMS, upon entry into our collaboration agreement with BMS and the upfront payment of $150.0 million that we received in January 2025 from Novartis in connection with our entry into the research collaboration and license agreement with Novartis. However, we have received equity consideration in certain of our collaborators and/or the right to receive option fees, cash milestone payments upon the achievement of specified development, regulatory, and commercial sales milestones for the drug discovery targets, and potential royalties. From time to time, we have also made additional equity investments in our drug discovery collaborators.

We may never realize a return on our investment of resources and cash in our drug discovery collaborations. Clinical drug development involves a lengthy and expensive process, with an uncertain outcome. Our drug discovery collaborators may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of any product candidates. In addition, our ability to realize return from our drug discovery collaborations is subject to the following risks:

• drug discovery collaborators have significant discretion in determining the amount and timing of efforts and resources that they will apply to our collaborations and may not perform their obligations as expected;

• drug discovery collaborators may not pursue development or commercialization of any product candidates for which we are entitled to option fees, milestone payments, or royalties or may elect not to continue or renew development or commercialization programs based on results of clinical trials or other studies, changes in the collaborator’s strategic focus or available funding, or external factors, such as an acquisition, that divert resources or create competing priorities;

• drug discovery collaborators may delay clinical trials for which we are entitled to milestone payments;

• we may not have access to, or may be restricted from disclosing, certain information regarding our collaborators’ product candidates being developed or commercialized and, consequently, may have limited ability to inform our stockholders about the status of, and likelihood of achieving, milestone payments or royalties under such collaborations;

• drug discovery collaborators could independently develop, or develop with third parties, products that compete directly or indirectly with any product candidates and products for which we are entitled to milestone payments or royalties if the collaborator believes that the competitive products are more likely to be successfully developed or can be commercialized under terms that are more economically attractive;

• product candidates discovered in drug discovery collaborations with us may be viewed by our collaborators as competitive with their own product candidates or products, which may cause our collaborators to cease to devote resources to the commercialization of any such product candidates;

• existing drug discovery collaborators and potential future drug discovery collaborators may begin to perceive us to be a competitor more generally, particularly as we advance our proprietary drug discovery programs, and therefore may be unwilling to continue existing collaborations with us or to enter into new collaborations with us;

• a drug discovery collaborator may fail to comply with applicable regulatory requirements regarding the development, manufacture, distribution, or marketing of a product candidate or product, which may impact our ability to receive milestone payments;

• disagreements with drug discovery collaborators, including disagreements over intellectual property or proprietary rights, contract interpretation, or the preferred course of development, might cause delays or terminations of the research, development, or commercialization of product candidates for which we are eligible to receive milestone payments, or might result in litigation or arbitration;

• drug discovery collaborators may not properly obtain, maintain, enforce, defend or protect our intellectual property or proprietary rights or may use our proprietary information in such a way as to potentially lead to

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disputes or legal proceedings that could jeopardize or invalidate our or their intellectual property or proprietary information or expose us and them to potential litigation;

• drug discovery collaborators may infringe, misappropriate, or otherwise violate the intellectual property or proprietary rights of third parties, which may expose us to litigation and potential liability;

• drug discovery collaborators could suffer from operational delays as a result of global health impacts, such as the COVID-19 pandemic; and

• drug discovery collaborations may be terminated prior to our receipt of any significant value from the collaboration, which has happened to us in the past and may happen to us again in the future.

Our drug discovery collaborations may not lead to development or commercialization of product candidates that results in our receipt of option fees, milestone payments, or royalties in a timely manner, or at all. If any drug discovery collaborations that we enter into do not result in the successful development and commercialization of drug products that result in option fees, milestone payments, or royalties to us, we may not receive return on the resources we have invested in the drug discovery collaboration. Moreover, even if a drug discovery collaboration initially leads to the achievement of milestones that result in payments to us, it may not continue to do so.

We also rely on collaborators for the development and potential commercialization of product candidates we discover internally when we believe it will help maximize clinical and commercial opportunities for the product candidate. For example, under our research collaboration and license agreement with Novartis, we are responsible, together with Novartis, for the discovery of small molecule compounds directed against specified targets pursuant to mutually agreed research plans. After the identification of a development candidate in any project plan, Novartis will be solely responsible for the further preclinical and clinical development, manufacturing and commercialization of products containing all compounds resulting from such project plan. We cannot be certain that we will successfully identify development candidates for Novartis to develop and commercialize under our research collaboration and license agreement. Further, Novartis may not achieve the discovery, development, and commercial milestones for those development candidates that would result in additional payments to us.

We may not realize returns on our equity investments in our drug discovery collaborators.

We may not realize returns on our equity investments in our drug discovery collaborators. None of the drug discovery collaborators in which we hold equity generate revenue from commercial sales of drug products. They are therefore dependent on the availability of capital on favorable terms to continue their operations. In addition, if the drug discovery collaborators in which we hold equity raise additional capital, our ownership interest in and degree of control over these drug discovery collaborators will be diluted, unless we have sufficient resources and choose to invest in the drug discovery collaborator further or successfully negotiate contractual anti-dilution protections for our equity investment. The financial success of our equity investment in any collaborator will likely be dependent on a liquidity event, such as a public offering, acquisition, or other favorable market event reflecting appreciation in the value of the equity we hold. The capital markets for public offerings and acquisitions are dynamic, and the likelihood of liquidity events for the companies in which we hold equity interests could significantly worsen. Further, valuations of privately held companies are inherently complex due to the lack of readily available market data. If we determine that any of our investments in such companies have experienced a decline in value, we may be required to record an impairment, which could negatively impact our financial results. The fair value of our equity interests in public companies, such as Structure Therapeutics, may fluctuate significantly in future periods since we determine the fair value of such equity interests based on the market value of such companies’ common stock as of a given reporting date. All of the equity we hold in our drug discovery collaborators is subject to risk of partial or total loss of our investment.

Our drug discovery collaborators have significant discretion in determining when to make announcements, if any, about the status of our collaborations, including about clinical developments and timelines for advancing collaborative programs, and the price of our common stock may decline as a result of announcements of unexpected results or developments.

Our drug discovery collaborators have significant discretion in determining when to make announcements about the status of our collaborations, including about preclinical and clinical developments and timelines for advancing the collaborative programs. While as a general matter we intend to periodically report on the status of our collaborations, our drug discovery collaborators, and in particular, our privately-held collaborators, may wish to report such information more or less frequently than we intend to or may not wish to report such information at all. The price of our common stock may

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decline as a result of the public announcement of unexpected results or developments in our collaborations, or as a result of our collaborators withholding such information.

Although we believe that our computational platform has the potential to identify more promising molecules than traditional methods and to accelerate drug discovery, our efforts in using our platform technology to discover and design molecules with therapeutic potential may not result in the discovery and development of commercially viable products for us or our collaborators.

Our scientific approach focuses on using our platform technology to conduct "computational assays" that leverage our deep understanding of physics-based modeling and theoretical chemistry to design molecules and predict their key properties without conducting time-consuming and expensive physical experiments. Our computational platform underpins our software solutions, our drug discovery collaborations and our own proprietary drug discovery programs.

While the results of certain of our drug discovery collaborators suggest that our platform is capable of accelerating drug discovery and identifying high quality product candidates, these results do not assure future success for our drug discovery collaborators or for us with our proprietary drug discovery programs.

Even if we or our drug discovery collaborators are able to develop product candidates that demonstrate potential in preclinical studies, we or they may not succeed in demonstrating safety and efficacy of product candidates in human clinical trials. For example, in collaboration with us, Nimbus was able to identify a unique series of acetyl-CoA carboxylase, or ACC, allosteric protein-protein interaction inhibitors with favorable pharmaceutical properties that inhibit the activity of the ACC enzyme. Nimbus achieved proof of concept in a Phase 1b clinical trial of its ACC inhibitor, firsocostat, and later sold the program to Gilead Sciences, Inc., or Gilead Sciences, in a transaction valued at approximately $1.2 billion, comprised of an upfront payment and earn outs. Of this amount, $601.3 million has been paid to Nimbus to date, and we received a total of $46.0 million in cash distributions in 2016 and 2017. In December 2019, Gilead Sciences announced topline results from its Phase 2 clinical trial which included firsocostat, both as a monotherapy and in combination with other investigational therapies for advanced fibrosis due to nonalcoholic steatohepatitis, in which the primary endpoint was not met. Gilead Sciences completed a Phase 2b clinical trial evaluating firsocostat in combination with Novo Nordisk A/S’s semaglutide, a GLP-1 receptor agonist, for compensated cirrhosis due to nonalcoholic steatohepatitis. Moreover, preclinical and clinical data are often susceptible to varying interpretations and analyses, and many companies that have believed their product candidates performed satisfactorily in preclinical studies and clinical trials have nonetheless failed to obtain marketing approval of their product candidates.

We may not be successful in our efforts to identify, discover or develop product candidates and may fail to capitalize on programs, collaborations, or product candidates that may present a greater commercial opportunity or for which there is a greater likelihood of success.

Research programs to identify new product candidates require substantial technical, financial, and human resources. As an organization, we are advancing SGR-1505, our clinical-stage MALT1 inhibitor, and SGR-3515, our clinical-stage Wee1/Myt1 inhibitor, and we may fail to identify additional product candidates for development. Similarly, a key element of our business plan is to expand the use of our computational platform through an increase in software sales and drug discovery collaborations. A failure to demonstrate the utility of our platform by successfully using it ourselves to discover internal product candidates could harm our business prospects.

Because we have limited resources, we focus our research programs on protein targets where we believe our computational assays are a good substitute for experimental assays, where we believe it is theoretically possible to discover a molecule with properties that are required for the molecule to become a drug and where we believe there is a meaningful commercial opportunity, among other factors. The focus of our initial proprietary drug discovery programs was in the area of oncology, and we have only recently begun expanding into other therapeutic areas, including neurology and immunology. We may forego or delay pursuit of opportunities with certain programs, collaborations, or product candidates or for indications that later prove to have greater commercial potential. However, the development of any product candidate we pursue may ultimately prove to be unsuccessful or less successful than another potential product candidate that we might have chosen to pursue on a more aggressive basis with our capital resources. If we do not accurately evaluate the commercial potential for a particular product candidate, we may relinquish valuable rights to that product candidate through strategic collaboration, partnership, licensing, or other arrangements in cases in which it would have been more advantageous for us to retain sole development and commercialization rights to such product candidate. Alternatively, we may allocate internal resources to a product candidate in a therapeutic area in which it would have been more advantageous to enter into a collaboration.

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Our research programs may show initial promise in identifying potential product candidates internally or with collaborators, yet fail to yield product candidates for clinical development for a number of reasons, including:

• our research methodology or that of any collaborator may be unsuccessful in identifying potential product candidates that are successful in clinical development;

• potential product candidates may be shown to have harmful side effects or may have other characteristics that may make the product candidates unmarketable or unlikely to receive marketing approval;

• our current or future collaborators may change their development profiles for potential product candidates or abandon a therapeutic area; or

• new competitive developments may render our product candidates obsolete or noncompetitive.

If any of these events occur, we may be forced to abandon our development efforts for a program or programs, which would have a material adverse effect on our business.

We rely on contract research organizations to synthesize any molecules with therapeutic potential that we discover. If such organizations do not meet our supply requirements, or if such organizations do not otherwise perform satisfactorily, development of any product candidate we may develop may be delayed.

We rely and expect to continue to rely on third parties to synthesize any molecules with therapeutic potential that we discover, including SGR-1505 and SGR-3515. Reliance on third parties may expose us to different risks than if we were to synthesize molecules ourselves. Our reliance on these third parties will reduce our control over these activities but will not relieve us of our responsibilities. If these third parties do not successfully carry out their contractual duties, meet expected deadlines, or synthesize molecules in accordance with regulatory requirements, if there are disagreements between us and such parties or if such parties are unable to expand capacities, we may not be able to fulfill, or may be delayed in producing sufficient product candidates to meet, our supply requirements, and we may not be able to complete, or may be delayed in completing, the necessary preclinical studies or the necessary clinical trials and we will not be able to, or may be delayed in our efforts to, successfully develop and commercialize such product candidates. The facilities of these third parties may also be affected by natural disasters, such as floods or fire, or geopolitical developments, such as tariffs and trade restrictions, or public health pandemics or such facilities could face production issues, such as contamination or regulatory concerns following a regulatory inspection of such facility. In such instances, we may need to locate an appropriate replacement third-party facility and establish a contractual relationship, which may not be readily available or on acceptable terms, which would cause additional delay and increased expense, and may have a material adverse effect on our business.

We or any third party may also encounter shortages in the raw materials or active pharmaceutical ingredient, or API, necessary to synthesize any molecule we may discover in the quantities needed for preclinical studies or clinical trials, as a result of capacity constraints or delays or disruptions in the market for the raw materials or API. Even if raw materials or API are available, we may be unable to obtain sufficient quantities at an acceptable cost or quality. The failure by us or the third parties to obtain the raw materials or API necessary to synthesize sufficient quantities of any molecule we may discover could delay, prevent, or impair our development efforts and may have a material adverse effect on our business.

If we are not able to establish or maintain collaborations to develop and commercialize any of the product candidates we discover internally, we may have to alter our development and commercialization plans for those product candidates and our business could be adversely affected.

We expect to rely on future collaborators for the development and potential commercialization of product candidates we discover internally when we believe it will help maximize the clinical and commercial opportunities of the product candidate. We face significant competition in seeking appropriate collaborators for these activities, and a number of more established companies may also be pursuing such collaborations. These established companies may have a competitive advantage over us due to their size, financial resources, and greater clinical development and commercialization expertise. Whether we reach a definitive agreement for such collaborations will depend, among other things, upon our assessment of the collaborator’s resources and expertise, the terms and conditions of the proposed collaboration, and the proposed collaborator’s evaluation of a number of factors. Those factors may include the design or results of preclinical studies and clinical trials, the likelihood of approval by the FDA or similar regulatory authorities outside the United States, the potential market for the subject product candidate, the costs and complexities of manufacturing and delivering such product candidate to patients, the potential of competing products, the existence of uncertainty with respect to our ownership of technology, which can exist if there is a challenge to such ownership without regard to the merits of the challenge, and industry and market conditions generally. The collaborator may also consider

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alternative product candidates or technologies for similar indications that may be available to collaborate on and whether such a collaboration could be more attractive than the one with us for our product candidate. Collaborations are complex and time-consuming to negotiate and document. In addition, there have been a significant number of recent business combinations among large biopharmaceutical companies that have resulted in a reduced number of potential future collaborators.

If we are unable to reach agreements with suitable collaborators on a timely basis, on acceptable terms or at all, we may have to curtail the development of a product candidate, reduce or delay its development program or one or more of our other development programs, or increase our expenditures and undertake development or commercialization activities at our own expense. If we elect to fund and undertake development or commercialization activities on our own, we may need to obtain additional expertise and additional capital, which may not be available to us on acceptable terms or at all. If we fail to enter into collaborations and do not have sufficient funds or expertise to undertake the necessary development and commercialization activities, we may not be able to further develop any product candidates or bring them to market.

As a company, we have very limited experience in clinical development, which may adversely impact the likelihood that we will be successful in advancing our programs.

As a company, we have very limited experience in clinical development. Our limited experience in designing, conducting and completing clinical development activities may adversely impact the likelihood that we will be successful in advancing our programs. Further, any predictions you make about the future success or viability of our proprietary drug discovery programs may not be as accurate as they could be if we had a history of conducting and completing clinical trials and developing our own product candidates.

Further, if we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies governing clinical trials, our development plans may be impacted. For example, in December 2022, with the passage of Food and Drug Omnibus Reform Act, or FDORA, Congress required sponsors to develop and submit a diversity action plan, or DAP, for each phase 3 clinical trial or any other "pivotal study" of a new drug or biological product. These plans are meant to encourage the enrollment of more diverse patient populations in late-stage clinical trials of FDA-regulated products. The legislation directs the FDA to issue new guidance on DAPs. In June 2024, the FDA issued draft guidance outlining the general requirements for DAPs. Unlike most guidance documents issued by the FDA, the guidance when finalized will have the force of law because FDORA specifically dictates that the form and manner for submission of DAPs are specified in FDA guidance. On January 27, 2025, in response to an executive order issued by President Trump on January 21, 2025, on Diversity, Equity and Inclusion programs, the FDA removed the draft DAP guidance from its website. On July 3, 2025, the U.S. District Court for the District of Columbia ruled that the administration’s actions to remove these webpages, including the draft DAP guidance, is unlawful under the Administrative Procedure Act and ordered the restoration of many of these webpages. In late July 2025, the FDA restored the draft DAP guidance to the FDA’s website with a statement that "information on this page may be modified and/or removed in the future subject to the terms of the court's order and implemented consistent with applicable law." Accordingly, in light of these ongoing actions, there is considerable uncertainty surrounding the draft DAP guidance and how the FDA will consider DAPs in connection with its review of marketing applications.

In addition, the regulatory landscape related to clinical trials in the European Union, or EU, has evolved. The EU Clinical Trials Regulation, or CTR, became applicable on January 31, 2022. While the Clinical Trials Directive required a separate clinical trial application, or CTA, to be submitted in each member state, to both the competent national health authority and an independent ethics committee, the CTR introduces a centralized process and only requires the submission of a single application to all member states concerned. The CTR allows sponsors to make a single submission to both the competent authority and an ethics committee in each member state, leading to a single decision per member state. The assessment procedure of the CTA has been harmonized as well, including a joint assessment by all member states concerned, and a separate assessment by each member state with respect to specific requirements related to its own territory, including ethics rules. Each member state’s decision is communicated to the sponsor via the centralized EU portal. Once the CTA is approved, clinical study development may proceed. The CTR foresees a three-year transition period. The extent to which ongoing and new clinical trials will be governed by the CTR varies. For clinical trials whose CTA was made under the Clinical Trials Directive before January 31, 2022, the Clinical Trials Directive applied until January 31, 2025. Additionally, sponsors were still permitted to choose to submit a CTA under either the Clinical Trials Directive or the CTR until January 31, 2023 and, if authorized, those will be governed by the Clinical Trials Directive until January 31, 2025. Beginning January 31, 2025, all ongoing trials are subject to the provisions of the CTR.

As our proprietary drug discovery business grows, we may encounter unforeseen expenses, difficulties, complications, delays, and other known and unknown factors. Our proprietary drug discovery business will need to

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transition to a business capable of supporting significant clinical development activities. We may not be successful in such a transition.

Conducting successful clinical trials requires the enrollment of a sufficient number of patients, and suitable patients may be difficult to identify and recruit.

Conducting successful clinical trials requires the enrollment of a sufficient number of patients, and suitable patients may be difficult to identify and recruit. Identifying and qualifying patients to participate in future clinical trials for any other product candidate we develop is critical to our success. Patient enrollment in clinical trials and completion of patient participation and follow-up depends on many factors, including the severity of disease; size of the patient population; the nature of the trial protocol; the attractiveness of, or the discomforts and risks associated with, the treatments received by enrolled subjects; the availability of clinical trial investigators with appropriate competencies and experience; support staff; the number of ongoing clinical trials in the same indication that compete for the same patients; proximity of patients to clinical sites; the number and availability of trial sites; the ability to comply with the eligibility and exclusion criteria for participation in the clinical trial; ability to obtain and maintain patient consents; patient compliance; the ability to monitor patients during and after treatment; and the impact of any health pandemic or epidemic. For example, patients may be discouraged from enrolling in our clinical trials if the trial protocol requires them to undergo extensive post-treatment procedures or follow-up to assess the safety and effectiveness of our product candidates. Patients may also not participate in our clinical trials if they choose to participate in contemporaneous clinical trials of competitive products with competitors that have more clinical development experience than we do.

Our inability to locate and enroll a sufficient number of patients for our clinical trials would result in significant delays, could require us to abandon one or more clinical trials altogether and could delay or prevent our receipt of necessary regulatory approvals. Enrollment delays in our clinical trials may result in increased development costs for our product candidates, which would cause the value of our company to decline and limit our ability to obtain additional financing.

We rely on, and plan to continue to rely on, third parties to conduct our clinical trials, and those third parties may not perform satisfactorily, including failing to meet deadlines for the completion of such trials, which may prevent or delay our ability to seek or obtain marketing approval for or commercialize our product candidates or otherwise harm our business.

We rely on, and plan to continue to rely on, third-party contract research organizations, or CROs, in addition to other third parties such as research collaboratives and consortia, clinical data management organizations, medical institutions and clinical investigators, to conduct our ongoing and future clinical trials, including for SGR-1505 and SGR-3515. These contract research organizations and other third parties play a significant role in the conduct and timing of these trials and subsequent collection and analysis of data. These third-party arrangements might terminate for a variety of reasons, including a failure to perform by the third parties. If we need to enter into alternative arrangements, our product development activities might be delayed.

Our reliance on third parties for research and development activities reduces our control over these activities but does not relieve us of our responsibilities. For example, we are responsible for ensuring that each of our trials is conducted in accordance with the applicable protocol, and legal, regulatory and scientific standards, and our reliance on third parties does not relieve us of our responsibility to comply with any such standards. We and these third parties are required to comply with current good clinical practices, or cGCP, which are regulations and guidelines enforced by the FDA for all of our products in clinical development. Regulatory authorities in Europe and other jurisdictions have similar requirements. Regulatory authorities enforce these cGCPs through periodic inspections of trial sponsors, principal investigators and trial sites. If we or any of these third parties fail to comply with applicable cGCPs, the clinical data generated in our clinical trials may be deemed unreliable and the FDA or comparable foreign regulatory authorities may require us to perform additional clinical trials before approving our marketing applications. We cannot assure you that a given regulatory authority will determine that any of our clinical trials comply with cGCP regulations. We also are required to register ongoing clinical trials and post the results of completed clinical trials on a U.S. government-sponsored database, clinicaltrials.gov, within certain timeframes. Failure to do so can result in fines, adverse publicity and civil and criminal sanctions.

Furthermore, third parties on whom we rely may also have relationships with other entities, some of which may be our competitors. In addition, these third parties are not our employees, and except for remedies available to us under our agreements with such third parties, we cannot control whether or not they devote sufficient time and resources to our

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ongoing clinical, nonclinical and preclinical programs. If these third parties do not successfully carry out their contractual duties or obligations or meet expected deadlines, if they need to be replaced or if the quality or accuracy of the clinical data they obtain is compromised, our clinical trials may be extended, delayed or terminated and we may not be able to obtain, or may be delayed in obtaining, marketing approvals for our product candidates and will not be able to, or may be delayed in our efforts to, successfully commercialize our medicines.

In addition, we currently rely on foreign CROs and contract manufacturing organizations, or CMOs, and will likely continue to rely on foreign CROs and CMOs in the future. Foreign CMOs may be subject to U.S. legislation, including sanctions, tariffs and trade restrictions and other foreign regulatory requirements which could increase the cost or reduce the supply of material available to us, delay the procurement or supply of such material or have an adverse effect on our ability to secure significant commitments from governments to purchase our potential therapies.

Our reliance on third parties to manufacture our product candidates increases the risk that we will not have sufficient quantities of our product candidates or products or such quantities at an acceptable cost, which could delay, prevent or impair our development or commercialization efforts.

We do not own or operate manufacturing facilities for the production of any product candidates, nor do we have plans to develop our own manufacturing operations. We rely and expect to continue to rely on third-party contract manufacturers for all of our required raw materials, drug substance, and finished drug product for the preclinical and clinical development of any product candidates we develop ourselves and for any commercial supply of approved products, if any. We have limited personnel with experience in drug manufacturing and lack the resources and the capabilities to manufacture any of our product candidates on a clinical or commercial scale.

In order to conduct preclinical studies and clinical trials of our product candidates, we will need to identify suitable manufacturers with the capabilities to manufacture our compounds in large quantities in a manner consistent with existing regulations. Our third-party manufacturers may be unable to successfully increase the manufacturing capacity for any of our product candidates in a timely or cost-effective manner, or at all. In addition, quality issues may arise during scale-up activities and at any other time. If our manufacturers are unable to successfully scale up the manufacture of our product candidates in sufficient quality and quantity, the development, testing and clinical trials of that product candidate may be delayed or infeasible, and regulatory approval or commercial launch of that product candidate may be delayed or not obtained, which could significantly harm our business.

We do not currently have any agreements with third-party manufacturers for the long-term supply of any of our product candidates. In the future, we may be unable to enter into agreements with third-party manufacturers for commercial supplies of our product candidates, or may be unable to do so on acceptable terms.

Even if we are able to establish and maintain arrangements with third-party manufacturers, reliance on third-party manufacturers entails risks, including reliance on the third party for regulatory compliance and quality assurance; the possible breach of the manufacturing agreement by the third party; the possible misappropriation of our proprietary information, including our trade secrets and know-how; and the possible termination or nonrenewal of the agreement by the third party at a time that is costly or inconvenient for us.

Third-party manufacturers may not be able to comply with cGMP regulations or similar regulatory requirements outside the United States. Our failure, or the failure of our third-party manufacturers, to comply with applicable regulations could result in sanctions being imposed on us, including fines, injunctions, civil penalties, delays, suspension or withdrawal of approvals, license revocation, seizures or recalls of product candidates or products, operating restrictions and criminal prosecutions, any of which could significantly and adversely affect supplies of our product candidates.

Our product candidates and any products that we may develop may compete with other product candidates and products for access to manufacturing facilities. There are a limited number of manufacturers that operate under cGMP regulations and that might be capable of manufacturing for us. If the third parties that we engage to supply any materials or manufacture product for our preclinical tests and clinical trials should cease to continue to do so for any reason, including as a result of tariffs or trade restrictions, we likely would experience delays in advancing these trials while we identify and qualify replacement suppliers, and we may be unable to obtain replacement supplies on terms that are favorable to us. In addition, if we are not able to obtain adequate supplies of our product candidates or the substances used to manufacture them or any approved drug we may use in combination trials, it will be more difficult for us to develop our product candidates and compete effectively.

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Our current and anticipated future dependence upon others for the manufacture of our product candidates may adversely affect our future results of operations and our ability to develop product candidates and commercialize any products that receive marketing approval on a timely and competitive basis.

If serious adverse or unacceptable side effects are identified during the development or commercialization of our product candidates, we may need to abandon or limit our development and/or commercialization efforts for such product candidates.

If serious adverse events or undesirable side effects are observed in any of our clinical trials, we may have difficulty recruiting patients to our clinical trials, patients may drop out of our trials, or we may be required to abandon the trials or our development efforts of one or more product candidates altogether or limit development to certain uses or subpopulations in which the serious adverse events, undesirable side effects or other characteristics are less prevalent, less severe or more acceptable from a risk-benefit perspective. We, the FDA, comparable foreign regulatory authorities or an independent institutional review board may suspend clinical trials of a product candidate at any time for various reasons, including a belief that subjects or patients in such trials are being exposed to unacceptable health risks or adverse side effects. For example, in August 2025, we announced the discontinuation of the clinical development program for SGR-2921, our CDC7 inhibitor, which was being evaluated in a Phase 1 dose-escalation clinical trial in patients with relapsed/refractory acute myeloid leukemia, or AML, or high-risk myelodysplastic syndromes. Despite early evidence of monotherapy activity observed in the Phase 1 clinical trial, based on the profile observed prior to discontinuation, including two emergent events where SGR-2921 was considered to have contributed to two deaths in patients with AML, we determined the path to development as a combination therapy would be difficult to pursue.

Some potential therapeutics developed in the biotechnology industry that initially showed therapeutic promise in early-stage trials have later been found to cause side effects that prevented their further development. Even if the side effects do not preclude the product candidate from obtaining or maintaining marketing approval, undesirable side effects may inhibit market acceptance of the approved product due to its tolerability versus other therapies. In addition, adverse events which had initially been considered unrelated to the study treatment may later, even following approval and/or commercialization, be found to be caused by the study treatment. Any of these developments could materially harm our business, financial condition and prospects.

The outcome of preclinical studies and early clinical trials may not be predictive of the success of later clinical trials, and the results of our clinical trials may not satisfy the requirements of the FDA or other comparable foreign regulatory authorities.

Before obtaining regulatory approvals for the commercial sale of any of our product candidates, we will be required to demonstrate with substantial evidence through well-controlled clinical trials that our product candidates are safe and effective for their intended uses. Clinical testing is expensive and can take many years to complete, and its outcome is inherently uncertain. Failure can occur at any time during the clinical trial process. Success in preclinical studies and early-stage clinical trials does not mean that future clinical trials will be successful. The results of our product candidates in preclinical studies may not be indicative of future results in our ongoing or later stage clinical trials. Product candidates in later-stage clinical trials may fail to demonstrate sufficient safety and efficacy to the satisfaction of the FDA and other comparable foreign regulatory authorities despite having progressed through preclinical studies and early-stage clinical trials.

In some instances, there can be significant variability in safety and efficacy results between different clinical trials of the same product candidate due to numerous factors, including changes in trial protocols, differences in size and type of the patient populations, differences in and adherence to the dosing regimen and other trial protocols and the rate of dropout among clinical trial participants. Patients treated with our product candidates may also be undergoing surgical, radiation and chemotherapy treatments and may be using other approved products or investigational new drugs, which can cause side effects or adverse events that are unrelated to our product candidate. As a result, assessments of efficacy can vary widely for a particular patient, and from patient to patient and site to site within a clinical trial. This subjectivity can increase the uncertainty of, and adversely impact, our clinical trial outcomes. We do not know whether any clinical trials we may conduct will demonstrate consistent or adequate efficacy and safety sufficient to obtain marketing approval to market our product candidates. Most product candidates that begin clinical trials are never approved by regulatory authorities for commercialization.

Moreover, preclinical studies and clinical data are often susceptible to varying interpretations and analyses and many companies that believed their product candidates performed satisfactorily in preclinical studies and clinical trials nonetheless failed to obtain FDA or comparable foreign regulatory authority approval. We cannot guarantee that the FDA

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or comparable foreign regulatory authorities will interpret trial results as we do, and more trials than we anticipated could be required before we are able to submit applications seeking approval of our product candidates. To the extent that the results of the trials are not satisfactory to the FDA or comparable foreign regulatory authorities for support of a marketing application, we may be required to expend significant resources, which may not be available to us, to conduct additional trials in support of potential approval of our product candidates. Even if regulatory approval is secured for any of our product candidates, the terms of such approval may limit the scope and use of our product candidate, which may also limit its commercial potential. Furthermore, the approval policies or regulations of the FDA or comparable foreign regulatory authorities may significantly change in a manner rendering our clinical data insufficient for approval, which may lead to the FDA or comparable foreign regulatory authorities delaying, limiting or denying approval of our product candidates.

Interim, initial, "topline", and preliminary data from our clinical trials that we announce or publish in the future may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data.

From time to time, we may publicly disclose interim, initial, preliminary or topline data from our clinical trials, including our ongoing Phase 1 clinical trial of SGR-1505 and our ongoing Phase 1 clinical trial of SGR-3515, which are based on a preliminary analysis of then-available data, and the results and related findings and conclusions are subject to change following a more comprehensive review of the data related to the particular trial. Interim data from clinical trials that we may complete are subject to the risk that one or more of the clinical outcomes may materially change as patient enrollment continues and more patient data become available or as patients from our clinical trials continue other treatments for their disease. We will also have to make assumptions, estimations, calculations and conclusions as part of our analyses of data, and we may not have received or had the opportunity to fully and carefully evaluate all data. As a result, the interim, initial, topline or preliminary results that we report may differ from future results of the same trials, or different conclusions or considerations may qualify such results, once additional data have been received and fully evaluated. Preliminary or topline data also remain subject to audit and verification procedures that may result in the final data being materially different from the preliminary or topline data we previously published. As a result, interim, initial, topline and preliminary data should be viewed with caution until the final data are available.

Adverse differences between interim data and final data could significantly harm our reputation and business prospects and may cause volatility in the price of our common stock.

We conduct, and we intend to continue to conduct, clinical trials for our product candidates at sites outside the United States. The FDA may not accept data from trials conducted in such locations, and the conduct of trials outside the United States could subject us to additional delays and expense.

We conduct, and we intend to continue to conduct, clinical trials for our product candidates at trial sites that are located outside the United States. Although the FDA may accept data from clinical trials conducted outside the United States, acceptance of these data is subject to certain conditions imposed by the FDA.

In cases where data from foreign clinical trials are intended to serve as the sole basis for marketing approval in the United States, the FDA will generally not approve the application on the basis of foreign data alone unless (i) the data are applicable to the U.S. population and U.S. medical practice; (ii) the trials were performed by clinical investigators of recognized competence and pursuant to cGCP regulations; and (iii) the data may be considered valid without the need for an on-site inspection by the FDA, or if the FDA considers such inspection to be necessary, the FDA is able to validate the data through an on-site inspection or other appropriate means.

In addition, even where the foreign study data are not intended to serve as the sole basis for approval, the FDA will not accept the data as support for an application for marketing approval unless the study satisfies certain conditions. For example, the clinical trial must be well designed and conducted and performed by qualified investigators in accordance with cGCPs. The FDA must be able to validate the data from the trial, including, if necessary, through an onsite inspection. The trial population must also have a similar profile to the U.S. population and the data must be applicable to the U.S. population and U.S. medical practice in ways that the FDA deems clinically meaningful, except to the extent the disease being studied does not typically occur in the United States. In addition, while these clinical trials are subject to the applicable local laws, FDA acceptance of the data will be dependent upon its determination that the trials also complied with all applicable U.S. laws and regulations. There can be no assurance that the FDA will accept data from trials conducted outside of the United States. If the FDA does not accept the data from any trial that we conduct outside the United States, it would likely result in the need for additional trials, which would be costly and time-consuming and delay or permanently halt our development of our product candidates or potential product candidates in the future.

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In addition, the conduct of clinical trials outside the United States could have a significant adverse impact on us. Risks inherent in conducting international clinical trials include: clinical practice patterns and standards of care that vary widely among countries; non-U.S. regulatory authority requirements that could restrict or limit our ability to conduct our clinical trials; administrative burdens of conducting clinical trials under multiple non-U.S. regulatory authority schema; foreign exchange rate fluctuations; and diminished protection of intellectual property in some countries.

If we and any current or future collaborators are unable to successfully complete clinical development, obtain regulatory approval for, or commercialize any product candidates, or experience delays in doing so, our business may be materially harmed.

We are early in our development efforts for our own proprietary drug discovery programs. Our ability to generate product revenues, which we do not expect will occur for many years, if ever, will depend heavily on the successful development and eventual commercialization of our product candidates. The success of our and any current or future collaborators’ development and commercialization programs will depend on several factors, including the following:

• successful completion of necessary preclinical studies to enable the initiation of clinical trials;

• successful enrollment of patients in, and the completion of, the clinical trials;

• acceptance by the FDA or other regulatory agencies of regulatory filings for any product candidates we and our current or future collaborators may develop;

• expanding and maintaining a workforce of experienced scientists and other technical specialists to continue to develop any product candidates;

• obtaining and maintaining intellectual property protection and regulatory exclusivity for any product candidates we and our current or future collaborators may develop;

• making arrangements with third-party manufacturers for, or establishing, clinical and commercial manufacturing capabilities;

• establishing sales, marketing, and distribution capabilities for drug products and successfully launching commercial sales, if and when approved;

• acceptance of any product candidates we and our current or future collaborators may develop, if and when approved, by patients, the medical community, and third-party payors;

• effectively competing with other therapies;

• obtaining and maintaining coverage, adequate pricing, and adequate reimbursement from third-party payors, including government payors;

• patients’ willingness to pay out-of-pocket in the absence of coverage and/or adequate reimbursement from third-party payors;

• any restrictions resulting from a health epidemic or pandemic and its collateral consequences may result in internal and external operational delays and limitations; and

• maintaining a continued acceptable safety profile following receipt of any regulatory approvals.

Many of these factors are beyond our control, including clinical outcomes, the regulatory review process, potential threats to our intellectual property rights, and the manufacturing, marketing, and sales efforts of any current or future collaborator. Clinical drug development involves a lengthy and expensive process, with an uncertain outcome. If we or our current or future collaborators are unable to develop, receive marketing approval for, and successfully commercialize any product candidates, or if we or they experience delays as a result of any of these factors or otherwise, we may need to spend significant additional time and resources, which would adversely affect our business, prospects, financial condition, and results of operations.

Even if any product candidate that we may develop receives marketing approval, it may fail to achieve the degree of market acceptance by physicians, patients, third-party payers and others in the medical community necessary for commercial success.

If any product candidate we may develop receives marketing approval, it may nonetheless fail to gain sufficient market acceptance by physicians, patients, third-party payers and others in the medical community. Sales of medical products depend in part on the willingness of physicians to prescribe the treatment, which is likely to be based on a

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determination by these physicians that the products are safe, therapeutically effective and cost-effective. In addition, the inclusion or exclusion of products from treatment guidelines established by various physician groups and the viewpoints of influential physicians can affect the willingness of other physicians to prescribe the treatment. We cannot predict whether physicians, physicians’ organizations, hospitals, other healthcare providers, government agencies or private insurers will determine that any of our product candidates, if approved for commercial sale, is safe, therapeutically effective and cost-effective as compared with competing treatments. Efforts to educate the medical community and third-party payers on the benefits of any product candidates we may develop may require significant resources and may not be successful. If any product candidates we may develop do not achieve an adequate level of acceptance, we may not generate significant product revenues and we may not become profitable. The degree of market acceptance of any product candidates we may develop, if approved for commercial sale, will depend on a number of factors, including:

•    the efficacy and safety of such product candidates as demonstrated in clinical trials;

•    the potential advantages and limitations compared to alternative treatments;

•    the effectiveness of sales and marketing efforts;

•    the cost of treatment in relation to alternative treatments;

•    the clinical indications for which the product is approved;

•    the convenience and ease of administration compared to alternative treatments;

•    the willingness of the target patient population to try new therapies and of physicians to prescribe these therapies;

•    the strength of marketing and distribution support;

•    the timing of market introduction of competitive products;

•    the availability of third-party coverage and adequate reimbursement;

•    the prevalence and severity of any side effects; and

•    any restrictions on the use of our products, if approved, together with other medications.

Clinical trial and product liability lawsuits against us could divert our resources, could cause us to incur substantial liabilities and could limit commercialization of our product candidates.

We face an inherent risk of clinical trial and product liability exposure related to the testing of our product candidates in clinical trials, and we will face an even greater risk if we commercially sell any products that we may develop. While we currently have no product candidates that have been approved for commercial sale, the use of product candidates by us in clinical trials, and the sale of any approved products in the future, may expose us to liability claims. These claims might be made by patients that use the product, healthcare providers, pharmaceutical companies or others selling such products. If we cannot successfully defend ourselves against claims that our product candidates or products caused injuries, we will incur substantial liabilities. Regardless of merit or eventual outcome, liability claims may result in:

•    decreased demand for any product candidates we may develop;

•    injury to our reputation and significant negative media attention;

•    withdrawal of clinical trial participants;

•    significant costs to defend any related litigation;

•    substantial monetary awards to trial participants or patients;

•    loss of revenue;

•    reduced resources of our management to pursue our business strategy; and

•    the inability to commercialize any product candidates we may develop.

We have insurance coverage in countries in which we conduct clinical trials and will need to increase our insurance coverage if we conduct clinical trials in additional countries or of additional product candidates or if we commence commercialization of any product candidates. Insurance coverage is increasingly expensive. We may not be able to maintain insurance coverage at a reasonable cost or in an amount adequate to satisfy any liability that may arise. If a successful clinical trial or product liability claim or series of claims is brought against us for uninsured liabilities or in

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excess of insured liabilities, our assets may not be sufficient to cover such claims and our business operations could be impaired.

We face substantial competition, which may result in others discovering, developing or commercializing products before or more successfully than we do, thus rendering our products non-competitive, obsolete or reducing the size of our market.

We face competition with respect to our and our collaborators’ product candidates from many biopharmaceutical and biotechnology companies. The biotechnology and pharmaceutical industries are characterized by rapidly advancing technologies, intense competition and a strong emphasis on proprietary and novel products and product candidates. Our competitors have developed, are developing or may develop products, product candidates that are competitive with or superior to our product candidates. Any product candidates that we successfully develop and commercialize, internally or with our collaborators, will compete with existing therapies and new therapies that may become available in the future.

In particular, there is intense competition in the field of oncology, which is a focus of our drug discovery efforts. We have competitors both in the United States and internationally, including major multinational pharmaceutical companies, established biotechnology companies, specialty pharmaceutical companies, emerging and start-up companies, universities and other research institutions. We also compete with these organizations to recruit management, scientists and clinical development personnel, which could negatively affect our level of expertise and our ability to execute our business plan. We also face competition in finding and establishing clinical trial sites, enrolling subjects for clinical trials, assessing combination studies and recruiting credible principal investigators and advisors from key clinical disciplines and academic centers.

For example, with respect to our MALT1 inhibitor, SGR-1505, which we are advancing for the treatment of patients with relapsed or refractory B-cell malignancies, we are aware of several MALT1 inhibitors in clinical development, including by AbbVie Inc., HotSpot Therapeutics, and Recursion Pharmaceuticals, Inc. In addition, we are also aware of other therapeutics, such as bi-specifics and CAR-Ts, both approved and in clinical development, for the treatment of B-cell malignancies.

With respect to our Wee1/Myt1 inhibitor, SGR-3515, which we are advancing for the treatment of advanced solid tumors, we are aware of several Wee1 inhibitors in clinical development, including by Zentalis Pharmaceuticals, Debiopharm International SA, IMPACT Therapeutics, Inc., Shouyao Holdings Co. Ltd., BioCity Biopharma, and Aprea Therapeutics, Inc., as well as a Myt1 inhibitor in clinical development being advanced by Debiopharm International S.A., and a Wee1/Myt1 inhibitor being advanced by Acrivon Therapeutics, Inc.

Large pharmaceutical and biotechnology companies, in particular, have extensive experience in building and accessing networks of expert investigators, designing and conducting clinical trials, obtaining regulatory approvals, and manufacturing and commercializing biotechnology products. These companies also have significantly greater research and development and marketing capabilities than we do and may also have products that have been approved or are in late stages of development, and collaborative arrangements in our target markets with leading companies and research institutions. Established pharmaceutical and biotechnology companies may also invest heavily to accelerate discovery and development of novel compounds or to in-license novel compounds that could make the product candidates that we develop obsolete. Our commercial opportunity could be reduced or eliminated if our competitors develop and commercialize products that are safer, more effective, have fewer or less severe side effects, are more convenient or are less expensive than our products. Smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies, as well as in acquiring technologies complementary to, or necessary for, our programs. As a result of all of these factors, our competitors may succeed in obtaining approval from the FDA or other comparable foreign regulatory authorities or in discovering, developing and commercializing products in our field before we do.

Risks Related to Our Operations

Doing business internationally creates operational and financial risks for our business.

For the three months ended March 31, 2026 and the year ended December 31, 2025, sales to customers outside of the United States accounted for approximately 46% and 40% of our total revenues, respectively. Operating in international markets requires significant resources and management attention and subjects us to regulatory, economic, and political risks that are different from those in the United States. We have limited operating experience in some international markets, and we cannot assure you that our expansion efforts into other international markets will be successful. Our experience in

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the United States and other international markets in which we already have a presence may not be relevant to our ability to expand in other markets. Our international expansion efforts may not be successful in creating further demand for our solutions outside of the United States or in effectively selling our solutions in the international markets we enter. In addition, we face risks in doing business internationally that could adversely affect our business, including:

• the need to localize and adapt our solutions for specific countries, including translation into foreign languages;

• data privacy laws which require that customer data be stored and processed in a designated territory or handled in a manner that differs significantly from how we typically handle customer data;

• difficulties in staffing and managing foreign operations, including employee laws and regulations;

• different pricing environments, longer sales cycles, and longer accounts receivable payment cycles and collections issues;

• differences in healthcare systems, drug regulation and reimbursement, and drug discovery and development practices and technologies;

• new and different sources of competition;

• weaker protection for intellectual property and other legal rights than in the United States and practical difficulties in enforcing intellectual property and other rights outside of the United States;

• laws and business practices favoring local competitors;

• compliance challenges related to the complexity of multiple, conflicting, and changing governmental laws and regulations, including employment, tax, reimbursement and pricing, privacy and data protection, and anti-bribery laws and regulations;

• increased financial accounting and reporting burdens and complexities;

• restrictions on the transfer of funds;

• changes in diplomatic and trade relationships, including new tariffs, trade protection measures, import or export licensing requirements, trade embargoes, and other trade barriers;

• changes in social, political, and economic conditions or in laws, regulations, and policies governing foreign trade, manufacturing, development, and investment both domestically as well as in the other countries and jurisdictions;

• adverse tax consequences, including the potential for required withholding taxes;

• global health pandemics or epidemics, such as the COVID-19 pandemic; and

• unstable regional, economic and political conditions.

Our international agreements may provide for payment denominated in local currencies and our local operating costs are denominated in local currencies. Therefore, fluctuations in the value of the U.S. dollar and foreign currencies may impact our operating results when translated into U.S. dollars.

Furthermore, with respect to our proprietary drug discovery programs, the ongoing war between Russia and Ukraine may impact the ability of our CROs in the region to produce materials we require to conduct certain of our preclinical studies. If we are unable to obtain alternative sources for such materials that we require, the ability for us to timely execute and complete certain of our preclinical studies may be adversely impacted.

If we fail to manage our technical operations infrastructure, our existing customers, and our internal drug discovery team, may experience service outages, and our new customers may experience delays in the deployment of our solutions.

We have experienced significant growth in the number of users and data that our operations infrastructure supports. We seek to maintain sufficient excess capacity in our operations infrastructure to meet the needs of all of our customers and to support our proprietary drug discovery programs. We also seek to maintain excess capacity to facilitate the rapid provision of new customer deployments and the expansion of existing customer deployments. In addition, we need to properly manage our technological operations infrastructure in order to support version control, changes in hardware and software parameters and the evolution of our solutions. However, the provision of new hosting infrastructure

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requires adequate lead-time. We have experienced, and may in the future experience, website disruptions, outages, and other performance problems. These types of problems may be caused by a variety of factors, including infrastructure changes, human or software errors, viruses, security attacks, fraud, spikes in usage, and denial of service issues. In some instances, we may not be able to identify the cause or causes of these performance problems within an acceptable period of time. If we do not accurately predict our infrastructure requirements, our existing customers may experience service outages that may subject us to financial penalties, financial liabilities, and customer losses. If our operations infrastructure fails to keep pace with increased sales and usage, customers and our internal drug discovery team may experience delays in the deployment of our solutions as we seek to obtain additional capacity, which could adversely affect our reputation and adversely affect our revenues.

Changes in tax laws or in their implementation or interpretation could adversely affect our business and financial condition.

Income, sales, use or other tax laws, statutes, rules, or regulations could be enacted or amended at any time, which could affect our business or financial condition, including causing potentially adverse impacts to our effective tax rate, tax liabilities, and cash tax obligations. For example, the Inflation Reduction Act, or IRA, was signed into law in August 2022, and the One Big Beautiful Bill Act, or OBBBA, was signed into law in July 2025. The IRA introduced new tax provisions, including a one percent excise tax imposed on certain stock repurchases by publicly traded companies. The one percent excise tax generally applies to any acquisition of stock by the publicly traded company (or certain of its affiliates) from a stockholder of the company in exchange for money or other property (other than stock of the company itself), subject to certain exceptions. Thus, the excise tax could apply to certain transactions that are not traditional stock repurchases. The OBBBA contains numerous tax provisions that we are currently in the process of evaluating, and which may significantly affect our business or financial condition. The changes under the OBBBA include tax rate extensions and changes to the business interest deduction limitation, the expensing of domestic research and development expenditures (in contrast to the continued capitalization and amortization of foreign research and development expenditures), the bonus depreciation deduction rules, and the international tax framework. Regulatory guidance under the IRA, the OBBBA, and other tax-related legislation is and continues to be forthcoming, and such guidance could ultimately increase or lessen the impact of these laws on our business and financial condition. In addition, it is uncertain if and to what extent various states will conform to the changes to federal tax legislation.

Our ability to use our NOLs and research and development tax credit carryforwards to offset future taxable income may be subject to certain limitations.

As of December 31, 2025, we had federal NOLs of approximately $208.5 million that do not expire and state NOLs of approximately $119.3 million, which, if not utilized, generally began to expire in 2025. As of December 31, 2025, we also had federal orphan drug credits and federal research and development tax credit carryforwards of approximately $44.0 million and various state tax credit carryforwards of approximately $4.7 million. Unused credits begin to expire in 2033 and generally expire over time if they remain unused. Certain of these NOLs, orphan drug credits, research and development, and various state tax credit carryforwards could expire unused and be unavailable to offset future income tax liabilities.

In addition, under Sections 382 and 383 of the Internal Revenue Code of 1986, as amended, and corresponding provisions of state law, a corporation that undergoes an "ownership change," generally defined as a greater than 50 percentage point change (by value) in its equity ownership by certain stockholders over a three-year period, is subject to limitations on its ability to utilize its pre-change NOLs and research and development tax credit carryforwards to offset future taxable income. We have performed an analysis through December 31, 2025 and determined no such ownership change had occurred. If such an ownership change were to occur in the future, our ability to use our NOLs and research and development tax credit carryforwards may be materially limited.

There is also a risk that due to regulatory changes, such as suspension of the use of NOLs, or other unforeseen reasons, our existing NOLs could expire or otherwise become unavailable to offset future income tax liabilities. In addition, state NOLs generated in one state cannot be used to offset income generated in another state. For these reasons, we may be unable to use a material portion of our NOLs and other tax attributes.

Our international operations subject us to potentially adverse tax consequences.

We report our taxable income in various jurisdictions worldwide based upon our business operations in those jurisdictions. These jurisdictions include Germany, United Kingdom, Japan, India and South Korea. The international

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nature and organization of our business activities are subject to complex transfer pricing regulations administered by taxing authorities in various jurisdictions. The relevant taxing authorities may disagree with our determinations as to the income and expenses attributable to specific jurisdictions. If such a disagreement were to occur, and our position were not sustained, we could be required to pay additional taxes, interest, and penalties, which could result in one-time tax charges, higher effective tax rates, reduced cash flows, and lower overall profitability of our operations.

Taxing authorities may successfully assert that we should have collected or in the future should collect sales and use, value added, or similar taxes, and we could be subject to tax liabilities with respect to past or future sales, which could adversely affect our results of operations.

We do not collect sales and use, value added, and similar taxes in all jurisdictions in which we have sales, based on our belief that such taxes are not applicable or that we are not required to collect such taxes with respect to the jurisdiction. Sales and use, value added, and similar tax laws and rates vary greatly by jurisdiction. Certain jurisdictions in which we do not collect such taxes may assert that such taxes are applicable, which could result in tax assessments, penalties, and interest, and we may be required to collect such taxes in the future. Such tax assessments, penalties, and interest or future requirements may adversely affect our results of operations.

Unanticipated changes in our effective tax rate could harm our future results.

We are subject to income taxes in the United States and various foreign jurisdictions, and our domestic and international tax liabilities are subject to the allocation of expenses in differing jurisdictions. Forecasting our estimated annual effective tax rate is complex and subject to uncertainty, and there may be material differences between our forecasted and actual tax rates. Our effective tax rate could be adversely affected by changes in the mix of earnings and losses in countries with differing statutory tax rates, certain non-deductible expenses as a result of acquisitions, the valuation of deferred tax assets and liabilities, and changes in federal, state, or international tax laws and accounting principles. Increases in our effective tax rate would reduce our profitability or in some cases increase our losses.

In addition, we may be subject to income tax audits by many tax jurisdictions throughout the world. Although we believe our income tax liabilities are reasonably estimated and accounted for in accordance with applicable laws and principles, an adverse resolution of one or more uncertain tax positions in any period could have a material impact on the results of operations for that period.

We have acquired, and we may again in the future acquire, companies, businesses, solutions or technologies, which could divert our management’s attention, result in additional dilution to our stockholders, and otherwise disrupt our operations and adversely affect our operating results.

We have acquired, and we may again in the future acquire, businesses, solutions, or technologies that we believe could complement or expand our solutions, enhance our technical capabilities, or otherwise offer growth opportunities. The pursuit of potential acquisitions may divert the attention of management and cause us to incur various expenses in identifying, investigating, and pursuing suitable acquisitions, whether or not they are consummated.

In addition, we have limited experience in acquiring other businesses. If we acquire additional businesses, we may not be able to integrate the acquired personnel, operations, and technologies successfully, effectively manage the combined business following the acquisition or preserve the operational synergies between our business units that we believe currently exist. We cannot assure you that following any acquisition we would achieve the expected synergies to justify the transaction, due to a number of factors, including:

• inability to integrate or benefit from acquired technologies or services in a profitable manner;

• unanticipated costs or liabilities associated with the acquisition;

• acquisition-related costs;

• difficulty integrating the accounting systems, operations, and personnel of the acquired business;

• difficulties and additional expenses associated with supporting legacy products and hosting infrastructure of the acquired business;

• difficulty converting the customers of the acquired business onto our solutions and contract terms, including disparities in the revenues, licensing, support, or professional services model of the acquired company;

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• diversion of management’s attention from other business concerns;

• adverse effects to our existing business relationships with business partners and customers as a result of the acquisition;

• the potential loss of key employees;

• use of resources that are needed in other parts of our business; and

• use of substantial portions of our available cash to consummate the acquisition.

In addition, a significant portion of the purchase price of companies we acquire may be allocated to acquired goodwill and other intangible assets, which must be assessed for impairment at least annually. In the future, if our acquisitions do not yield expected returns, we may be required to take charges to our operating results based on this impairment assessment process, which could adversely affect our results of operations.

Acquisitions could also result in dilutive issuances of equity securities or the incurrence of debt, which could adversely affect our operating results. In addition, if an acquired business fails to meet our expectations, our operating results, business, and financial position may suffer.

Our operations may be interrupted by the occurrence of a natural disaster or other catastrophic event at our primary facilities.

Our operations are primarily conducted at our facilities in New York, New York, Portland, Oregon, and Hyderabad, India, and our internal hosting facility located in Clifton, New Jersey. The occurrence of natural disasters or other catastrophic events could disrupt our operations. Any natural disaster or catastrophic event in our facilities or the areas in which they are located could have a significant negative impact on our operations.

Risks Related to Our Intellectual Property

If we fail to comply with our obligations under our existing license agreements with Columbia University, under any of our other intellectual property licenses, or under any future intellectual property licenses, or otherwise experience disruptions to our business relationships with our current or any future licensors, we could lose intellectual property rights that are important to our business.

We are party to a number of license agreements pursuant to which we have been granted exclusive and non-exclusive worldwide licenses to certain patents, software code, and software programs to, among other things, reproduce, use, execute, copy, operate, sublicense, and distribute the licensed technology in connection with the marketing and sale of our software solutions and to develop improvements thereto. In particular, the technology that we license from Columbia University pursuant to our license agreements with them are used in and incorporated into a number of our software solutions which we market and license to our customers. For further information regarding our license agreements with Columbia University, see "Item 1. Business—License Agreements with Columbia University" in our Annual Report on Form 10-K for the fiscal year ended December 31, 2025. Our license agreements with Columbia University and other licensors impose, and we expect that future licenses will impose, specified royalty and other obligations on us.

In spite of our best efforts, our current or any future licensors might conclude that we have materially breached our license agreements with them and might therefore terminate the license agreements, thereby delaying our ability to market and sell our existing software solutions and develop and commercialize new software solutions that utilize technology covered by these license agreements. If these in-licenses are terminated, or if the underlying intellectual property fails to provide the intended exclusivity, competitors could market products and technologies similar to ours. This could have a material adverse effect on our competitive position, business, financial condition, results of operations, and prospects.

Disputes may arise regarding intellectual property subject to a licensing agreement, including:

• the scope of rights granted under the license agreement and other interpretation related issues;

• the extent to which our technology and processes infringe on intellectual property of the licensor that is not subject to the licensing agreement;

• the sublicensing of patent and other rights under any collaborative development relationships;

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• the inventorship and ownership of inventions and know-how resulting from the joint creation or use of intellectual property by our current or future licensors and us and our collaborators; and

• the priority of invention of patented technology.

In addition, license agreements are complex, and certain provisions in such agreements may be susceptible to multiple interpretations. The resolution of any contract interpretation disagreement that may arise could narrow what we believe to be the scope of our rights to the relevant intellectual property or technology, or increase what we believe to be our financial or other obligations under the relevant agreement. For example, our counterparties have in the past and may in the future dispute the amounts owed to them pursuant to payment obligations. If disputes over intellectual property that we have licensed prevent or impair our ability to maintain our current licensing arrangements on commercially acceptable terms, we may experience delays in the development and commercialization of new software solutions and in our ability to market and sell existing software solutions, which could have a material adverse effect on our business, financial condition, results of operations, and prospects.

Our obligations under our existing or future drug discovery collaboration agreements may limit our intellectual property rights that are important to our business. Further, if we fail to comply with our obligations under our existing or future collaboration agreements, or otherwise experience disruptions to our business relationships with our prior, current, or future collaborators, we could lose intellectual property rights that are important to our business.

We are party to collaboration agreements with biopharmaceutical companies, pursuant to which we provide drug discovery services but have no ownership rights, or only co-ownership rights, to certain intellectual property generated through the collaborations. We are also party to a research collaboration and license agreement with Novartis for the discovery, research and preclinical development of small molecule compounds for targets in certain specified therapeutic areas, which also provides for joint ownership rights to certain intellectual property generated through the collaboration in certain scenarios. We may enter into additional collaboration agreements in the future, pursuant to which we may have no ownership rights, or only co-ownership rights, to certain intellectual property generated through the future collaborations. If we are unable to obtain ownership or license of such intellectual property generated through our prior, current, or future collaborations and overlapping with, or related to, our own proprietary technology or product candidates, then our business, financial condition, results of operations, and prospects could be materially harmed.

Our existing collaboration agreements contain certain exclusivity obligations that require us to design compounds exclusively for our collaborators with respect to certain specific targets over a specified time period. Our future collaboration agreements may grant similar exclusivity rights to future collaborators with respect to target(s) that are the subject of such collaborations. Existing or future collaboration agreements may also impose diligence obligations on us. For example, existing or future collaboration agreements may impose restrictions on us from pursuing the drug development targets for ourselves or for our other current or future collaborators, thereby removing our ability to develop and commercialize, or to jointly develop and commercialize with other current or future collaborators, product candidates, and technology related to the drug development targets. Under our collaboration with Novartis, for example, we are prohibited from researching, developing, manufacturing, modifying, improving or commercializing any small molecule directed against collaboration targets ourselves or with a third party during a specified period and subject to specified exceptions. In spite of our best efforts, our prior, current, or future collaborators might conclude that we have materially breached our collaboration agreements. If these collaboration agreements are terminated, or if the underlying intellectual property, to the extent we have ownership or license of such intellectual property, fails to provide the intended exclusivity, competitors would have the freedom to seek regulatory approval of, and to market, products and technology identical to ours. This could have a material adverse effect on our competitive position, business, financial condition, results of operations, and prospects.

Disputes may arise regarding intellectual property subject to a collaboration agreement, including:

• the scope of ownership or license granted under the collaboration agreement and other interpretation related issues;

• the extent to which our technology and product candidates infringe on intellectual property of the collaborator of which we do not have ownership or license under the collaboration agreement;

• the assignment or sublicense of intellectual property rights and other rights under the collaboration agreement;

• our diligence obligations under the collaboration agreement and what activities satisfy those diligence obligations; and

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• the inventorship and ownership of inventions and know-how resulting from the joint creation or use of intellectual property by us and our current or future collaborators.

In addition, collaboration agreements are complex, and certain provisions in such agreements may be susceptible to multiple interpretations. The resolution of any contract interpretation disagreement that may arise could narrow what we believe to be the scope of our rights to the relevant intellectual property, or increase what we believe to be our obligations under the relevant agreements, either of which could have a material adverse effect on our business, financial condition, results of operations, and prospects. Moreover, if disputes over intellectual property that we have owned, co-owned, or in-licensed under the collaboration agreements prevent or impair our ability to maintain our current collaboration arrangements on commercially acceptable terms, we may be unable to successfully develop and commercialize the affected technology or product candidates, which could have a material adverse effect on our business, financial condition, results of operations, and prospects.

If we are unable to obtain, maintain, enforce, and protect patent protection for our technology and product candidates or if the scope of the patent protection obtained is not sufficiently broad, our competitors could develop and commercialize technology and products similar or identical to ours, and our ability to successfully develop and commercialize our technology and product candidates may be adversely affected.

Our success depends in large part on our ability to obtain and maintain protection of the intellectual property we may own solely and jointly with others or may license from others, particularly patents, in the United States and other countries with respect to any proprietary technology and product candidates we develop, including SGR-1505 and SGR-3515, and any trade secrets and know-how relevant to our product candidates. We seek to protect our proprietary position by filing patent applications in the United States and abroad related to our technology and any product candidates we may develop that are important to our business and by in-licensing intellectual property related to our technology and product candidates. If we are unable to obtain or maintain patent protection with respect to any proprietary technology or product candidate, our business, financial condition, results of operations, and prospects could be materially harmed.

The patent prosecution process is expensive, time-consuming, and complex, and we may not be able to file, prosecute, maintain, defend, or license all necessary or desirable patent applications at a reasonable cost or in a timely manner. It is also possible that we will fail to identify patentable aspects of our research and development output before it is too late to obtain patent protection. Moreover, in some circumstances, we may not have the right to control the preparation, filing, and prosecution of patent applications, or to maintain, enforce, and defend the patents, covering technology that we co-own with third parties or license from third parties. Therefore, these co-owned and in-licensed patents and applications may not be prepared, filed, prosecuted, maintained, defended, and enforced in a manner consistent with the best interests of our business.

The patent position of software and biopharmaceutical companies generally is highly uncertain, involves complex legal and factual questions, and has in recent years been the subject of much litigation. In addition, the scope of patent protection outside of the United States is uncertain, and laws of non-U.S. countries may not protect our rights to the same extent as the laws of the United States or vice versa. With respect to both owned and in-licensed patent rights, we cannot predict whether the patent applications we, our collaborators, and our licensors are currently pursuing will issue as patents in any particular jurisdiction or whether the claims of any issued patents will provide sufficient protection from competitors.

For example, in jurisdictions outside the United States, a license may not be enforceable unless all the owners of the intellectual property agree or consent to the license. Accordingly, any actual or purported co-owner of our patent rights could seek monetary or equitable relief requiring us to pay it compensation for, or refrain from, exploiting these patents due to such co-ownership.

Furthermore, patents have a limited lifespan. In the United States, and most other jurisdictions in which we have undertaken patent filings, the natural expiration of a patent is generally twenty years after it is filed, assuming all maintenance fees are paid. Various extensions may be available, on a jurisdiction-by-jurisdiction basis; however, the life of a patent, and thus the protection it affords, is limited. Given the amount of time required for the development, testing and regulatory review of new product candidates, patents protecting such candidates might expire before or shortly after such candidates are commercialized. As a result, patents we may own or in-license may not provide us with adequate and continuing patent protection sufficient to exclude others from commercializing drugs similar or identical to our current or future product candidates, including generic versions of such drugs.

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Further, we may not be aware of all third-party intellectual property rights or prior art potentially relating to our computational platform, technology, and any product candidates we may develop. In addition, publications of discoveries in the scientific literature often lag behind the actual discoveries, and patent applications in the United States and other jurisdictions are typically not published until 18 months after filing of the priority application, or in some cases not published at all. Therefore, neither we nor our collaborators, or our licensor can know with certainty whether either we, our collaborators, or our licensor were the first to make the inventions claimed in the patents and patent applications we own or in-license now or in the future, or that either we, our collaborators, or our licensor were the first to file for patent protection of such inventions. As a result, the issuance, scope, validity, enforceability, and commercial value of our owned, co-owned, and in-licensed patent rights are highly uncertain. Moreover, our owned, co-owned, and in-licensed pending and future patent applications may not result in patents being issued that protect our technology and product candidates, in whole or in part, or that effectively prevent others from commercializing competitive technologies and products. Changes in either the patent laws or interpretation of the patent laws in the United States and other countries may diminish the value of our owned, co-owned, or in-licensed current or future patents and our ability to obtain, protect, maintain, defend, and enforce our patent rights, narrow the scope of our patent protection and, more generally, could affect the value of, or narrow the scope of, our patent rights. For example, recent Supreme Court decisions have served to curtail the scope of subject matter eligible for patent protection in the United States, and many software patents have since been invalidated on the basis that they are directed to abstract ideas.

In order to pursue protection based on our pending provisional patent applications, we will need to file Patent Cooperation Treaty applications, non-U.S. applications, and/or U.S. non-provisional patent applications prior to applicable deadlines. Even then, as highlighted above, patents may never issue from our patent applications, or the scope of any patent may not be sufficient to provide a competitive advantage.

Moreover, we, our collaborators, or our licensors may be subject to a third-party preissuance submission of prior art to the U.S. Patent and Trademark Office, or USPTO, or become involved in opposition, derivation, revocation, reexamination, inter partes review, post-grant review, or interference proceedings challenging our patent rights or the patent rights of others. An adverse determination in any such submission, proceeding, or litigation could reduce the scope of, or invalidate, our patent rights or allow third parties to commercialize our technology or product candidates and compete directly with us, without payment to us. If the breadth or strength of protection provided by our owned, co-owned, or in-licensed current or future patents and patent applications is threatened, regardless of the outcome, it could dissuade companies from collaborating with us to license, develop, or commercialize current or future technology or product candidates.

Additionally, the coverage claimed in a patent application can be significantly reduced before the patent is issued, and its scope can be reinterpreted after issuance. Even if our owned, co-owned, and in-licensed current and future patent applications issue as patents, they may not issue in a form that will provide us with any meaningful protection, prevent competitors from competing with us, or otherwise provide us with any competitive advantage. The issuance of a patent is not conclusive as to its inventorship, scope, validity, or enforceability, and our owned and in-licensed patents may be challenged in the courts or patent offices in the United States and abroad. Such challenges may result in loss of exclusivity or in patent claims being narrowed, invalidated, or held unenforceable, in whole or in part, which could limit our ability to stop others from using or commercializing similar or identical technology and products, or limit the duration of the patent protection of our technology and product candidates. Such proceedings also may result in substantial cost and require significant time from our management and employees, even if the eventual outcome is favorable to us. In particular, given the amount of time required for the development, testing, and regulatory review of new product candidates, patents protecting such candidates might expire before or shortly after such candidates are commercialized. Furthermore, our competitors may be able to circumvent our owned, co-owned, or in-licensed current or future patents by developing similar or alternative technologies or products in a non-infringing manner. As a result, our owned, co-owned, and in-licensed current or future patent portfolio may not provide us with sufficient rights to exclude others from commercializing technology and products similar or identical to any of our technology and product candidates.

In addition, we may in the future be subject to claims by our former employees or consultants asserting an ownership right in our patents or patent applications, as a result of the work they performed on our behalf. Although we generally require all of our employees, consultants and advisors, and any other third parties who have access to our proprietary know-how, information or technology to assign or grant similar rights to their inventions to us, we cannot be certain that we have executed such agreements with all parties who may have contributed to our intellectual property, nor can we be certain that our agreements with such parties will be upheld in the face of a potential challenge, or that they will not be breached, for which we may not have an adequate remedy.

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Changes to patent laws in the United States and other jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our products.

Changes in either the patent laws or interpretation of patent laws in the United States, including patent reform legislation such as the Leahy-Smith America Invents Act, or the Leahy-Smith Act, could increase the uncertainties and costs surrounding the prosecution of our owned and in-licensed patent applications and the maintenance, enforcement or defense of our owned and in-licensed issued patents. The Leahy-Smith Act includes a number of significant changes to United States patent law. These changes include provisions that affect the way patent applications are prosecuted, redefine prior art, provide more efficient and cost-effective avenues for competitors to challenge the validity of patents, and enable third-party submission of prior art to the USPTO during patent prosecution and additional procedures to attack the validity of a patent at USPTO-administered post-grant proceedings, including post-grant review, inter partes review, and derivation proceedings. Assuming that other requirements for patentability are met, prior to March 2013, in the United States, the first to invent the claimed invention was entitled to the patent, while outside the United States, the first to file a patent application was entitled to the patent. After March 2013, under the Leahy-Smith Act, the United States transitioned to a first-to-file system in which, assuming that the other statutory requirements for patentability are met, the first inventor to file a patent application will be entitled to the patent on an invention regardless of whether a third party was the first to invent the claimed invention. As such, the Leahy-Smith Act and its implementation could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued patents, all of which could have a material adverse effect on our business, financial condition, results of operations and prospects.

In addition, the patent positions of companies in the development and commercialization of software, biologics and pharmaceuticals are particularly uncertain. Recent U.S. Supreme Court rulings have narrowed the scope of patent protection available in certain circumstances and weakened the rights of patent owners in certain situations. This combination of events has created uncertainty with respect to the validity and enforceability of patents once obtained. Depending on future actions by the U.S. Congress, the federal courts, and the USPTO, the laws and regulations governing patents could change in unpredictable ways that could have a material adverse effect on our patent rights and our ability to protect, defend and enforce our patent rights in the future.

A number of cases decided by the U.S. Supreme Court have involved questions of when claims reciting abstract ideas, laws of nature, natural phenomena and/or natural products are eligible for a patent, regardless of whether the claimed subject matter is otherwise novel and inventive. These cases include Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 12-398 (2013) or Myriad; Alice Corp. v. CLS Bank International, 573 U.S. 13-298 (2014); and Mayo Collaborative Services v. Prometheus Laboratories, Inc., or Prometheus, 566 U.S. 10-1150 (2012). In response to these cases, federal courts have held numerous patents invalid as claiming subject matter ineligible for patent protection. Moreover, the USPTO has issued guidance to the examining corps on how to apply these cases during examination. As a result of these decisions, obtaining broad patents in the United States covering software innovations is more challenging than before.

In addition to increasing uncertainty with regard to our ability to obtain future patents, this combination of events has created uncertainty with respect to the value of patents, once obtained. Depending on these and other decisions by Congress, the federal courts and the USPTO, the laws and regulations governing patents could change or be interpreted in unpredictable ways that would weaken our ability to obtain new patents or to enforce any patents that may issue to us in the future. In addition, these events may adversely affect our ability to defend any patents that may issue in procedures in the USPTO or in courts.

Obtaining and maintaining our patent protection depends on compliance with various deadlines and procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated if we fail to comply with these deadlines and requirements. We may miss a filing deadline for patent protection on these inventions.

The USPTO and foreign governmental patent agencies require compliance with a number of procedural, documentary, fee payment and other similar provisions during the patent application process and after issuance of any patent. In addition, periodic maintenance fees, renewal fees, annuity fees and/or various other government fees are required to be paid. While an inadvertent lapse can be cured in some cases by payment of a late fee or by other means in accordance with the applicable rules, there are situations in which noncompliance can result in abandonment or lapse of the patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction. Noncompliance events that could result in abandonment or lapse of a patent include, but are not limited to, failure to respond to official actions within prescribed time limits, non-payment of fees and failure to properly legalize and submit formal documents. In such

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an event, our competitors might be able to enter the market with similar or identical products or platforms, which could have a material adverse effect on our business prospects and financial condition.

Intellectual property rights do not guarantee commercial success of current or future product candidates or other business activities. Numerous factors may limit any potential competitive advantage provided by our intellectual property rights.

The degree of future protection afforded by our intellectual property rights, whether owned or in-licensed, is uncertain because intellectual property rights have limitations, and may not adequately protect our business, provide a barrier to entry against our competitors or potential competitors, or permit us to maintain our competitive advantage. Moreover, if a third-party has intellectual property rights that cover the practice of our technology, we may not be able to fully exercise or extract value from our intellectual property rights. The following examples are illustrative:

• patent applications that we own or may in-license may not lead to issued patents;

• patents, should they issue, that we may own or in-license, may not provide us with any competitive advantages, may be narrowed in scope, or may be challenged and held invalid or unenforceable;

• others may be able to develop and/or practice technology, including compounds that are similar to the chemical compositions of our current or future product candidates, that is similar to our technology or aspects of our technology but that is not covered by the claims of any patents we may own or in-license, should any patents issue;

• third parties may compete with us in jurisdictions where we do not pursue and obtain patent protection;

• we, or our future licensors or collaborators, might not have been the first to make the inventions covered by a patent application that we own or may in-license;

• we, or our future licensors or collaborators, might not have been the first to file patent applications covering a particular invention;

• others may independently develop similar or alternative technologies without infringing, misappropriating or otherwise violating our intellectual property rights;

• our competitors might conduct research and development activities in the United States and other countries that provide a safe harbor from patent infringement claims for certain research and development activities, as well as in countries where we do not have patent rights, and may then use the information learned from such activities to develop competitive products for sale in our major commercial markets;

• we may not be able to obtain and/or maintain necessary licenses on reasonable terms or at all;

• third parties may assert an ownership interest in our intellectual property and, if successful, such disputes may preclude us from exercising exclusive rights, or any rights at all, over that intellectual property;

• we may choose not to file a patent in order to maintain certain trade secrets or know-how, and a third-party may subsequently file a patent covering such trade secrets or know-how;

• we may not be able to maintain the confidentiality of our trade secrets or other proprietary information;

• we may not develop or in-license additional proprietary technologies that are patentable; and

• the patents of others may have an adverse effect on our business.

Should any of these events occur, they could significantly harm our business, financial condition, results of operations and prospects.

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We, our prior, existing, or future collaborators, and our existing or future licensors, may become involved in lawsuits to protect or enforce our patent or other intellectual property rights, which could be expensive, time-consuming and unsuccessful.

Competitors and other third parties may infringe, misappropriate, or otherwise violate our, our prior, current and future collaborators’, or our current and future licensors’ issued patents or other intellectual property. As a result, we, our prior, current, or future collaborators, or our current or future licensor may need to file infringement, misappropriation, or other intellectual property related claims, which can be expensive and time-consuming. Any claims we assert against perceived infringers could provoke such parties to assert counterclaims against us alleging that we infringe, misappropriate, or otherwise violate their intellectual property. In addition, in a patent infringement proceeding, such parties could assert that the patents we, our collaborators, or our licensors have asserted are invalid or unenforceable. In patent litigation in the United States, defenses alleging invalidity or unenforceability are commonplace. Grounds for a validity challenge could be an alleged failure to meet any of several statutory requirements, including lack of novelty, obviousness, or non-enablement. Grounds for an unenforceability assertion could be an allegation that someone connected with prosecution of the patent withheld relevant information from the USPTO, or made a misleading statement, during prosecution. Third parties may institute such claims before administrative bodies in the United States or abroad, even outside the context of litigation. Such mechanisms include re-examination, post-grant review, inter partes review, interference proceedings, derivation proceedings, and equivalent proceedings in non-U.S. jurisdictions (e.g., opposition proceedings). The outcome following legal assertions of invalidity and unenforceability is unpredictable.

An adverse result in any such proceeding could put one or more of our owned, co-owned, or in-licensed current or future patents at risk of being invalidated or interpreted narrowly and could put any of our owned, co-owned, or in-licensed current or future patent applications at risk of not yielding an issued patent. A court may also refuse to stop the third party from using the technology at issue in a proceeding on the grounds that our owned, co-owned, or in-licensed current or future patents do not cover such technology. Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of our confidential information or trade secrets could be compromised by disclosure during this type of litigation. Any of the foregoing could allow such third parties to develop and commercialize competing technologies and products in a non-infringing manner and have a material adverse impact on our business, financial condition, results of operations, and prospects.

Interference or derivation proceedings provoked by third parties, or brought by us or by our collaborators or licensor, or declared by the USPTO may be necessary to determine the priority of inventions with respect to our patents or patent applications. An unfavorable outcome could require us to cease using the related technology or to attempt to license rights to it from the prevailing party. Our business could be harmed if the prevailing party does not offer us a license on commercially reasonable terms or at all, or if a non-exclusive license is offered and our competitors gain access to the same technology. Our defense of litigation or interference or derivation proceedings may fail and, even if successful, may result in substantial costs and distract our management and other employees. In addition, the uncertainties associated with litigation could have a material adverse effect on our ability to raise the funds necessary to conduct clinical trials, continue our research programs, license necessary technology from third parties, or enter into development collaborations that would help us bring any product candidates to market.

Third parties may initiate legal proceedings alleging that we are infringing, misappropriating or otherwise violating their intellectual property rights, the outcome of which would be uncertain and could have a material adverse effect on the success of our business.

Our commercial success depends upon our ability and the ability of our collaborators and licensor to develop, manufacture, market, and sell any product candidates we may develop and for our collaborators, licensor, customers, and partners to use our proprietary technologies without infringing, misappropriating, or otherwise violating the intellectual property and proprietary rights of third parties. There is considerable patent and other intellectual property litigation in the software, pharmaceutical, and biotechnology industries. We may become party to, or threatened with, adversarial proceedings or litigation regarding intellectual property rights with respect to our technology and product candidates, including interference proceedings, post grant review, inter partes review, and derivation proceedings before the USPTO and similar proceedings in non-U.S. jurisdictions such as oppositions before the European Patent Office. Numerous U.S. and non-U.S. issued patents and pending patent applications, which are owned by third parties, exist in the fields in which we are pursuing development candidates. As the biotechnology and pharmaceutical industries expand and more patents are issued, the risk increases that our technologies or product candidates that we may identify may be subject to claims of infringement of the patent rights of third parties.

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The legal threshold for initiating litigation or contested proceedings is low, so that even lawsuits or proceedings with a low probability of success might be initiated and require significant resources to defend. Litigation and contested proceedings can also be expensive and time-consuming, and our adversaries in these proceedings may have the ability to dedicate substantially greater resources to prosecuting these legal actions than we can. The risks of being involved in such litigation and proceedings may increase if and as any product candidates near commercialization and as we gain the greater visibility associated with being a public company. Third parties may assert infringement claims against us based on existing patents or patents that may be granted in the future, regardless of merit. We may not be aware of all such intellectual property rights potentially relating to our technology and product candidates and their uses, or we may incorrectly conclude that third-party intellectual property is invalid or that our activities and product candidates do not infringe such intellectual property. Thus, we do not know with certainty that our technology and product candidates, or our development and commercialization thereof, do not and will not infringe, misappropriate or otherwise violate any third party’s intellectual property.

Third parties may assert that we are employing their proprietary technology without authorization. There may be third-party patents or patent applications with claims to materials, formulations or methods, such as methods of manufacture or methods for treatment, related to the discovery, use or manufacture of the product candidates that we may identify or related to our technologies. Because patent applications can take many years to issue, there may be currently pending patent applications which may later result in issued patents that the product candidates that we may identify may infringe. In addition, third parties may obtain patents in the future and claim that use of our technologies infringes upon these patents. Moreover, as noted above, there may be existing patents that we are not aware of or that we have incorrectly concluded are invalid or not infringed by our activities. If any third-party patents were held by a court of competent jurisdiction to cover, for example, the manufacturing process of the product candidates that we may identify, any molecules formed during the manufacturing process or any final product itself, the holders of any such patents may be able to block our ability to commercialize such product candidate unless we obtained a license under the applicable patents, or until such patents expire.

Parties making claims against us may obtain injunctive or other equitable relief, which could effectively block our ability to further develop and commercialize the product candidates that we may identify. Defense of these claims, regardless of their merit, would involve substantial litigation expense and would be a substantial diversion of employee resources from our business. In the event of a successful claim of infringement against us, we may have to pay substantial damages, including treble damages and attorneys’ fees for willful infringement, pay royalties, redesign our infringing products, be forced to indemnify our customers, licensor, or collaborators or obtain one or more licenses from third parties, which may be impossible or require substantial time and monetary expenditure.

We may choose to take a license or, if we are found to infringe, misappropriate, or otherwise violate a third party’s intellectual property rights, we could also be required to obtain a license from such third party to continue developing, manufacturing and marketing our technology and product candidates. However, we may not be able to obtain any required license on commercially reasonable terms or at all. Even if we were able to obtain a license, it could be non-exclusive, thereby giving our competitors and other third parties access to the same technologies licensed to us and could require us to make substantial licensing and royalty payments. We could be forced, including by court order, to cease developing, manufacturing and commercializing the infringing technology or product. A finding of infringement could prevent us from commercializing any product candidates or force us to cease some of our business operations, which could materially harm our business. In addition, we may be forced to redesign any product candidates, seek new regulatory approvals and indemnify third parties pursuant to contractual agreements. Claims that we have misappropriated the confidential information or trade secrets of third parties could have a similar material adverse effect on our business, financial condition, results of operations, and prospects.

We may be subject to claims by third parties asserting that our employees, consultants, or contractors have wrongfully used or disclosed confidential information of third parties, or we have wrongfully used or disclosed alleged trade secrets of their current or former employers or claims asserting we have misappropriated their intellectual property, or claiming ownership of what we regard as our own intellectual property.

Certain of our employees, consultants, and contractors were previously employed at universities or other software or biopharmaceutical companies, including our competitors or potential competitors. Although we try to ensure that our employees, consultants and contractors do not use the proprietary information or know-how of others in their work for us, we may be subject to claims that these individuals or we have used or disclosed intellectual property, including trade secrets or other proprietary information, of any such individual’s current or former employer. Litigation may be necessary to defend against these claims.

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In addition, while it is our policy to require that our employees, consultants and contractors who may be involved in the development of intellectual property to execute agreements assigning such intellectual property to us, we may be unsuccessful in executing such an agreement with each party who in fact develops intellectual property that we regard as our own. Our intellectual property assignment agreements with them may not be self-executing or may be breached, and we may be forced to bring claims against third parties, or defend claims they may bring against us, to determine the ownership of what we regard as our intellectual property. Such claims could have a material adverse effect on our business, financial condition, results of operations, and prospects.

If we fail in prosecuting or defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights or personnel, which could have a material adverse effect on our competitive business position and prospects. Such intellectual property rights could be awarded to a third party, and we could be required to obtain a license from such third party to commercialize our technology or products, which license may not be available on commercially reasonable terms, or at all, or such license may be non-exclusive. Even if we are successful in prosecuting or defending against such claims, litigation could result in substantial costs and be a distraction to our management and employees.

If we are unable to protect the confidentiality of our trade secrets, our business and competitive position may be harmed.

In addition to seeking patents for any product candidates and technology, we also rely on trade secrets and confidentiality agreements to protect our unpatented know-how, technology, and other proprietary information, to maintain our competitive position. We seek to protect our trade secrets and other proprietary technology, in part, by entering into non-disclosure and confidentiality agreements with parties who have access to them, such as our employees, corporate collaborators, outside scientific collaborators, contract research organizations, contract manufacturers, consultants, advisors, collaborators, and other third parties. We also enter into confidentiality and invention or patent assignment agreements with our employees and consultants, but we cannot guarantee that we have entered into such agreements with each party that may have or has had access to our trade secrets or proprietary technology. Despite these efforts, any of these parties may inadvertently or intentionally breach the agreements and disclose our proprietary information, including our trade secrets, and we may not be able to obtain adequate remedies for such breaches. Detecting the disclosure or misappropriation of a trade secret and enforcing a claim that a party illegally disclosed or misappropriated a trade secret is difficult, expensive, and time-consuming, and the outcome is unpredictable. In addition, some courts inside and outside of the United States are less willing or unwilling to protect trade secrets. If any of our trade secrets were to be lawfully obtained or independently developed by a competitor or other third party, we would have no right to prevent them, or those to whom they communicate it, from using that technology or information to compete with us. If any of our trade secrets were to be disclosed to or independently developed by a competitor or other third party, our competitive position may be materially and adversely harmed.

If our product candidates or any of our future product candidates obtain regulatory approval, additional competitors could enter the market with generic versions of such products, which may result in a material decline in sales of our competing products.

Under the Drug Price Competition and Patent Term Restoration Act of 1984, or the Hatch-Waxman Amendments, to the Federal Food, Drug and Cosmetic Act, or FDCA, a company may file an abbreviated new drug application, or ANDA, seeking approval of a generic version of an approved innovator product. Under the Hatch-Waxman Amendments, a company may also submit a new drug application, or NDA, under section 505(b)(2) of the FDCA that references the FDA’s prior approval of the innovator product or preclinical studies and/or clinical trials that were not conducted by, or for, the sponsor and for which the sponsor has not obtained a right of reference. A 505(b)(2) NDA product may be for a new or improved version of the original innovator product. The Hatch-Waxman Amendments also provide for certain periods of regulatory exclusivity, which preclude FDA approval (or in some circumstances, FDA filing and review) of an ANDA or 505(b)(2) NDA.

In certain circumstances, third parties may file an ANDA or NDA under Section 505(b)(2) as early as the so-called “NCE-1” date that is one year before the expiry of the five-year period of New Chemical Entity exclusivity or more generally four years after NDA approval. The third parties are allowed to rely on the safety and effectiveness data of the innovator’s product, may not need to conduct clinical trials and can market a competing version of a product after the expiration or loss of patent exclusivity or the expiration or loss of regulatory exclusivity and often charge significantly lower prices. Upon the expiration or loss of patent protection or the expiration or loss of regulatory exclusivity for a product, the major portion of revenues for that product may be dramatically reduced in a very short period of time. If we are not successful in defending our patents and regulatory exclusivities, we will not derive the expected benefit from them.

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In addition to the benefits of regulatory exclusivity, an innovator NDA holder may have patents claiming the active ingredient, product formulation or an approved use of the drug, which would be listed with the product in the FDA publication “Approved Drug Products with Therapeutic Equivalence Evaluations,” known as the Orange Book. If there are patents listed in the Orange Book for the applicable, approved innovator product, a generic or 505(b)(2) sponsor that seeks to market its product before expiration of the patents must include in their applications what is known as a “Paragraph IV” certification, challenging the validity or enforceability, or claiming non-infringement, of the listed patent or patents. Notice of the certification must be given to the patent owner and NDA holder and if, within 45 days of receiving notice, either the patent owner or NDA holder sues for patent infringement, approval of the ANDA or 505(b)(2) NDA is stayed for up to 30 months.

Accordingly, if any of our product candidates that are regulated as drugs are approved, competitors could file ANDAs for generic versions of these products or 505(b)(2) NDAs that reference our products. If there are patents listed for such drug products in the Orange Book, those ANDAs and 505(b)(2) NDAs would be required to include a certification as to each listed patent indicating whether the ANDA sponsor does or does not intend to challenge the patent. We cannot predict which, if any, patents in our current portfolio or patents we may obtain in the future will be eligible for listing in the Orange Book, how any generic competitor would address such patents, whether we would sue on any such patents or the outcome of any such suit.

Risks Related to Regulatory and Other Legal Compliance Matters

Even if we complete the necessary preclinical studies and clinical trials, the regulatory approval process is expensive, time consuming and uncertain and may prevent us from obtaining approvals for the commercialization of some or all of our product candidates. As a result, we cannot predict when or if, and in which territories, we will obtain marketing approval to commercialize a product candidate.

The research, testing, manufacturing, labeling, approval, selling, marketing, promotion and distribution of products are subject to extensive regulation by the FDA and comparable foreign regulatory authorities. We are not permitted to market our product candidates in the United States or in other countries until we receive approval of a new drug application from the FDA or marketing approval from applicable regulatory authorities outside the United States. Our product candidates are in various stages of development and are subject to the risks of failure inherent in drug development. We have not submitted an application for or received marketing approval for any of our product candidates in the United States or in any other jurisdiction. We have no experience as a company in filing and supporting the applications necessary to gain marketing approvals and expect to rely on third-party CROs to assist us in this process.

The process of obtaining marketing approvals, both in the United States and abroad, is lengthy, expensive and uncertain. It may take many years, if approval is obtained at all, and can vary substantially based upon a variety of factors, including the type, complexity and novelty of the product candidates involved. Securing marketing approval requires the submission of extensive preclinical and clinical data and supporting information, including manufacturing information, to regulatory authorities for each therapeutic indication to establish the product candidate’s safety and efficacy. The FDA or other regulatory authorities may determine that our product candidates are not safe and effective, only moderately effective or have undesirable or unintended side effects, toxicities or other characteristics that preclude our obtaining marketing approval or prevent or limit commercial use.

In addition, under the Pediatric Research Equity Act, or PREA, applications and certain types of supplements to applications must contain data to assess the safety and effectiveness of the product in all relevant pediatric subpopulations and to support dosing and administration for each pediatric subpopulation for which the product is safe and effective, unless the sponsor receives a deferral or waiver from the FDA. A deferral may be granted for several reasons, including a finding that the product or therapeutic candidate is ready for approval for use in adults before pediatric trials are complete or that additional safety or effectiveness data needs to be collected before the pediatric trials begin. The applicable legislation in the European Union also requires sponsors to either conduct clinical trials in a pediatric population in accordance with a Pediatric Investigation Plan approved by the Pediatric Committee of EMA, or to obtain a waiver or deferral from the conduct of these studies by this Committee. For any of our product candidates for which we are seeking regulatory approval in the United States or the European Union, we cannot guarantee that we will be able to obtain a waiver or alternatively complete any required studies and other requirements in a timely manner, or at all, which could result in associated reputational harm and subject us to enforcement action.

The FDA may determine that we must provide additional evidence and data before approving a BLA or NDA for our product candidates. For example, the FDA reviews an application to determine whether there is “substantial evidence” to support a finding of effectiveness for the proposed product for its intended use(s), The FDA has interpreted this

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evidentiary standard to generally require at least two adequate and well-controlled clinical trials to establish effectiveness of a new product. Under certain circumstances, however, the FDA has indicated that a single trial with certain characteristics and additional confirmatory evidence may satisfy this standard. The FDA issued draft guidance in September 2023 that outlines considerations for relying on confirmatory evidence in lieu of a second clinical trial to demonstrate effectiveness. In the event that we submit a BLA or NDA on the basis of one clinical trial and confirmatory evidence, the FDA could determine that such information is not sufficient to support approval of the application and the agency could require us to conduct an additional trial in support of a BLA or NDA.

In addition, changes in marketing approval policies during the development period, changes in or the enactment or promulgation of additional statutes, regulations or guidance or changes in regulatory review for each submitted product application, may cause delays in the approval or rejection of an application. Regulatory authorities have substantial discretion in the approval process and varying interpretations of the data obtained from preclinical and clinical testing could delay, limit or prevent marketing approval of a product candidate. Any marketing approval we ultimately obtain may be limited or subject to restrictions or post-approval commitments that render the approved product not commercially viable.

Moreover, principal investigators for our clinical trials may serve as scientific advisors or consultants to us and receive compensation in connection with such services. Under certain circumstances, we may be required to report some of these relationships to the FDA or comparable foreign regulatory authorities. The FDA or a comparable foreign regulatory authority may conclude that a financial relationship between us and a principal investigator has created a conflict of interest or otherwise affected interpretation of the study. The FDA or comparable foreign regulatory authority may therefore question the integrity of the data generated at the applicable clinical trial site and the utility of the clinical trial itself may be jeopardized. This could result in a delay in approval, or rejection, of our marketing applications by the FDA or comparable foreign regulatory authority, as the case may be, and may ultimately lead to the denial of marketing approval of one or more of our product candidates.

Finally, we could be adversely affected by several significant administrative law cases decided by the U.S. Supreme Court in 2024. In Loper Bright Enterprises v. Raimondo , for example, the court overruled Chevron U.S.A., Inc. v. Natural Resources Defense Council, Inc. , which for 40 years required federal courts to defer to permissible agency interpretations of statutes that are silent or ambiguous on a particular topic. The U.S. Supreme Court stripped federal agencies of this presumptive deference and held that courts must exercise their independent judgment when deciding whether an agency such as the FDA acted within its statutory authority under the Administrative Procedure Act, or the APA. Additionally, in Corner Post, Inc. v. Board of Governors of the Federal Reserve System , the court held that actions to challenge a federal regulation under the APA can be initiated within six years of the date of injury to the plaintiff, rather than the date the rule is finalized. The decision appears to give prospective plaintiffs a personal statute of limitations to challenge longstanding agency regulations. Another decision, Securities and Exchange Commission v. Jarkesy , overturned regulatory agencies’ ability to impose civil penalties in administrative proceedings. These decisions could introduce additional uncertainty into the regulatory process and may result in additional legal challenges to actions taken by federal regulatory agencies, including the FDA and CMS. In addition to potential changes to regulations as a result of legal challenges, these decisions may result in increased regulatory uncertainty and delays and other impacts, any of which could adversely impact our business and operations.

Failure to obtain marketing approval in foreign jurisdictions would prevent any product candidates we may develop from being marketed in such jurisdictions, which, in turn, would materially impair our ability to generate revenue.

In order to market and sell any product candidate we may develop in the European Union and many other foreign jurisdictions, we or our collaborators must obtain separate marketing approvals and comply with numerous and varying local regulatory requirements. The approval procedure varies among countries and can involve additional testing. The time required to obtain approval may differ substantially from that required to obtain FDA approval. The regulatory approval process outside the United States generally includes all of the risks associated with obtaining FDA approval. In addition, in many countries outside the United States, it is required that the product be approved for reimbursement before the product can be approved for sale in that country. We or these third parties may not obtain approvals from regulatory authorities outside the United States on a timely basis, if at all. Approval by the FDA does not ensure approval by regulatory authorities in other countries or jurisdictions, and approval by one regulatory authority outside the United States does not ensure approval by regulatory authorities in other countries or jurisdictions or by the FDA. We may not be able to file for marketing approvals and we may not receive necessary approvals to commercialize our product candidates in any jurisdiction, which would materially impair our ability to generate revenue.

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Additionally, we could face heightened risks with respect to obtaining marketing authorization in the UK as a result of the withdrawal of the UK from the European Union, commonly referred to as Brexit. The UK is no longer part of the European Single Market and EU Customs Union. As of January 1, 2025, the Medicines and Healthcare Products Regulatory Agency, or MHRA, is responsible for approving all medicinal products destined for the United Kingdom market (i.e., Great Britain and Northern Ireland). On April 28, 2025, the UK Parliament adopted amendments to improve and strengthen the UK’s clinical trials regulatory regime, which will take effect on April 28, 2026. In anticipation of these new requirements, on October 1, 2025, the MHRA updated its guidance for clinical trials to address, among other things, research transparency requirements for clinical trials, the approvals process, Research Ethics Committee review of clinical trials, simplified arrangements for consent in clinical trials and pharmacovigilance. Since the UK left the European Union prior to the date on which the EU CTR took effect, the UK legal framework did not benefit from the same revisions as occurred at EU level.

At the same time, a new international recognition procedure, or IRP, will apply, which intends to facilitate approval of pharmaceutical products in the UK. The IRP is open to applicants that have already received an authorization for the same product from one of the MHRA’s specified Reference Regulators, or RRs. The RRs notably include EMA and regulators in the EU/European Economic Area member states for approvals in the EU centralized procedure and mutual recognition procedure as well as the FDA (for product approvals granted in the U.S.). However, the concrete functioning of the IRP is currently unclear. Any delay in obtaining, or an inability to obtain, any marketing approvals may force us or our collaborators to restrict or delay efforts to seek regulatory approval in the UK for our product candidates, which could significantly and materially harm our business.

In addition, foreign regulatory authorities may change their approval policies and new regulations may be enacted. For instance, the European Union pharmaceutical legislation is currently undergoing a complete review process, in the context of the Pharmaceutical Strategy for Europe initiative, launched by the European Commission in November 2020. The European Commission’s proposal for revision of several legislative instruments related to medicinal products (potentially reducing the duration of regulatory data protection, revising the eligibility for expedited pathways, etc.) was published on April 26, 2023. The proposed revisions remain to be agreed and adopted by the European Parliament and European Council and the proposals may therefore be substantially revised before adoption, which is not anticipated before early 2026. The revisions may, however, have a significant impact on the pharmaceutical industry and our business in the long term. On June 4, 2025, after almost two years of negotiations among the EU member states, the Council of the European Union adopted its position on the proposed overhaul of the EU general pharmaceutical legislative framework, which is known as the new Pharma Package. This proposal will now be the subject of additional negotiations and technical meetings, with the objective of reaching agreement on issues such as the regulatory data protection framework and the access and supply obligations. At this point, it appears that the period of market exclusivity for innovator products may be reduced from two years to one, exclusions from patent infringement for studies and trials will likely expand, and there will be a new obligation to ensure sufficient supply of medicines.

We expect that we will be subject to additional risks in commercializing any of our product candidates that receive marketing approval outside the United States, including tariffs, trade barriers and regulatory requirements; economic weakness, including inflation, or political instability in particular foreign economies and markets; compliance with tax, employment, immigration and labor laws for employees living or traveling abroad; foreign currency fluctuations, which could result in increased operating expenses and reduced revenue, and other obligations incident to doing business in another country; and workforce uncertainty in countries where labor unrest is more common than in the United States.

We, or our collaborators, may seek approval from the FDA or comparable foreign regulatory authorities to use accelerated development pathways for our product candidates. If we, or our collaborators, are not able to use such pathways, we, or they, may be required to conduct additional clinical trials beyond those that are contemplated, which would increase the expense of obtaining, and delay the receipt of, necessary marketing approvals, if we, or they, receive them at all. In addition, even if an accelerated approval pathway is available to us, or our collaborators, it may not lead to expedited approval of our product candidates, or approval at all.

Under the Federal Food, Drug and Cosmetic Act, or FDCA, and implementing regulations, the FDA may grant accelerated approval to a product candidate to treat a serious or life-threatening condition that provides meaningful therapeutic benefit over available therapies, upon a determination that the product has an effect on a surrogate endpoint or intermediate clinical endpoint that is reasonably likely to predict clinical benefit. The FDA considers a clinical benefit to be a positive therapeutic effect that is clinically meaningful in the context of a given disease, such as irreversible morbidity or mortality. For the purposes of accelerated approval, a surrogate endpoint is a marker, such as a laboratory measurement, radiographic image, physical sign, or other measure that is thought to predict clinical benefit, but is not itself a measure of clinical benefit. An intermediate clinical endpoint is a clinical endpoint that can be measured earlier than an effect on irreversible morbidity or mortality that is reasonably likely to predict an effect on irreversible morbidity or mortality or

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other clinical benefit measurement of a therapeutic effect that is considered reasonably likely to predict the clinical benefit of a drug. The accelerated approval pathway may be used in cases in which the advantage of a new drug over available therapy may not be a direct therapeutic advantage, but is a clinically important improvement from a patient and public health perspective. Similar risks to those described above are also applicable to any application that we, or our collaborators, may submit in other jurisdictions outside of the United States.

There can be no assurance that the FDA or foreign regulatory agencies will agree with our, or our collaborators’, surrogate endpoints or intermediate clinical endpoints in any of our, or their, clinical trials, or that we, or our collaborators, will decide to pursue or submit any NDA for accelerated approval or any other form of expedited development, review or approval. Similarly, there can be no assurance that, after feedback from the FDA or comparable foreign regulatory agencies, we, or our collaborators, will continue to pursue or apply for accelerated approval or any other form of expedited development, review or approval. Furthermore, for any submission of an application for accelerated approval or application under another expedited regulatory designation, there can be no assurance that such submission or application will be accepted for filing or that any expedited development, review or approval will be granted on a timely basis, or at all.

Finally, there can be no assurance that we will satisfy all FDA requirements, including new provisions, that govern accelerated approval. For example, with passage of the FDORA in December 2022, Congress modified certain provisions governing accelerated approval of drug and biologic products. Specifically, the new legislation authorized the FDA to require a sponsor to have its confirmatory clinical trial underway before accelerated approval is awarded and to submit progress reports on its post-approval studies to FDA every six months until the study is completed. Moreover, FDORA established expedited procedures authorizing FDA to withdraw an accelerated approval if certain conditions are met, including where a required confirmatory study fails to verify and describe the predicted clinical benefit or where evidence demonstrates the product is not shown to be safe or effective under the conditions of use. The FDA may also use such procedures to withdraw an accelerated approval if a sponsor fails to conduct any required post-approval study of the product with due diligence, including with respect to “conditions specified by the Secretary.” The new procedures include the provision of due notice and an explanation for a proposed withdrawal, and opportunities for a meeting with the FDA Commissioner or the FDA Commissioner’s designee and a written appeal, among other things. We will need to fully comply with these and other requirements in connection with the development and approval of any product candidate that qualifies for accelerated approval.

In March 2023, the FDA issued draft guidance that outlines its thinking and approach to accelerated approval. The FDA indicated that the accelerated approval pathway is commonly used for approval of oncology drugs due to the serious and life-threatening nature of cancer. Although single-arm trials have been commonly used to support accelerated approval, a randomized controlled trial is the preferred approach as it provides a more robust efficacy and safety assessment and allows for direct comparisons to an available therapy. To that end, the FDA outlined considerations for designing, conducting, and analyzing data for trials intended to support accelerated approvals of oncology therapeutics. Subsequently, in December 2024 and January 2025, the FDA issued additional draft guidances relating to accelerated approval. These guidances describe FDA’s views on what it means to conduct a confirmatory trial with due diligence and how the FDA plans to interpret whether such a study needs to be underway at the time of approval. While these guidances are currently only in draft form and will ultimately not be legally binding even when finalized, sponsors typically observe the FDA’s guidance closely to ensure that their investigational products qualify for accelerated approval.

Accordingly, a failure to obtain and maintain accelerated approval or any other form of expedited development, review or approval for our product candidates, or withdrawal of a product candidate, would result in a longer time period until commercialization of such product candidate, could increase the cost of development of such product candidate and could harm our competitive position in the marketplace.

We have and may continue to seek certain designations for our product candidates, including Breakthrough Therapy, Fast Track and Priority Review designations in the United States, and PRIME Designation in the European Union, but we might not receive such designations, and even if we do, such designations may not lead to a faster development or regulatory review or approval process.

We have and may continue to seek certain designations for one or more of our product candidates that could expedite review and approval by the FDA. A Breakthrough Therapy product is defined as a product that is intended, alone or in combination with one or more other products, to treat a serious condition, and preliminary clinical evidence indicates that the product may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development. For products that have been designated as Breakthrough Therapies, interaction and communication between the FDA and the sponsor of the trial can help to identify the most efficient path for clinical development while minimizing the number of patients placed in ineffective control regimens.

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The FDA may also designate a product for Fast Track review if it is intended, whether alone or in combination with one or more other products, for the treatment of a serious or life-threatening disease or condition, and it demonstrates the potential to address unmet medical needs for such a disease or condition. For Fast Track products, sponsors may have greater interactions with the FDA and the FDA may initiate review of sections of a Fast Track product’s application before the application is complete. This rolling review may be available if the FDA determines, after preliminary evaluation of clinical data submitted by the sponsor, that a Fast Track product may be effective. In June 2025, the FDA granted Fast Track designation for SGR-1505 for the treatment of adult patients with Waldenström macroglobulinemia that have failed at least two lines of therapy, including a BTK inhibitor.

We may also seek a priority review designation for one or more of our product candidates. If the FDA determines that a product candidate is intended to treat a serious condition, and if approved, offers a significant improvement in safety or effectiveness, the FDA may designate the product candidate for priority review. Significant improvement may be illustrated by evidence of increased effectiveness in the treatment of a condition, elimination or substantial reduction of a treatment-limiting product reaction, documented enhancement of patient compliance that may lead to improvement in serious outcomes, and evidence of safety and effectiveness in a new subpopulation. A priority review designation means that the goal for the FDA to review an application is six months, rather than the standard review period of ten months.

These designations are within the discretion of the FDA. Accordingly, even if we believe that one of our product candidates meets the criteria for these designations, the FDA may disagree and instead determine not to make such designation. Further, even if we receive a designation, the receipt of such designation for a product candidate may not result in a faster development or regulatory review or approval process compared to products considered for approval under conventional FDA procedures and does not assure ultimate approval by the FDA. In addition, even if one or more of our product candidates qualifies for these designations, the FDA may later decide that the product candidates no longer meet the conditions for qualification or decide that the time period for FDA review or approval will not be shortened.

In the European Union, we may seek PRIME designation for our product candidates in the future. PRIME is a voluntary program aimed at enhancing the EMA’s role to reinforce scientific and regulatory support in order to optimize development and enable accelerated assessment of new medicines that are of major public health interest with the potential to address unmet medical needs. The program focuses on medicines that target conditions for which there exists no satisfactory method of treatment in the European Union or even if such a method exists, it may offer a major therapeutic advantage over existing treatments. PRIME is limited to medicines under development and not authorized in the European Union and the applicant intends to apply for an initial marketing authorization application through the centralized procedure. To be accepted for PRIME, a product candidate must meet the eligibility criteria in respect of its major public health interest and therapeutic innovation based on information that is capable of substantiating the claims. The benefits of a PRIME designation include the appointment of a Committee for Medicinal Products for Human Use rapporteur to provide continued support and help to build knowledge ahead of a marketing authorization application, early dialogue and scientific advice at key development milestones, and the potential to qualify products for accelerated review, meaning reduction in the review time for an opinion on approvability to be issued earlier in the application process. PRIME enables an applicant to request parallel EMA scientific advice and health technology assessment advice to facilitate timely market access. Even if we receive PRIME designation for any of our product candidates, the designation may not result in a materially faster development process, review or approval compared to conventional EMA procedures. Further, obtaining PRIME designation does not assure or increase the likelihood of EMA’s grant of a marketing authorization.

We may not be able to obtain orphan drug exclusivity for any product candidates we may develop, and even if we do, that exclusivity may not prevent the FDA or the EMA from approving other competing products.

Under the Orphan Drug Act, the FDA may designate a product as an orphan drug if it is a drug or biologic intended to treat a rare disease or condition. A similar regulatory scheme governs approval of orphan products by the EMA in the European Union. Generally, if a product candidate with an orphan drug designation subsequently receives the first marketing approval for the indication for which it has such designation, the product is entitled to a period of marketing exclusivity, which precludes the FDA or the EMA from approving another marketing application for the same product for the same therapeutic indication for that time period. The applicable period is seven years in the United States and ten years in the European Union. The exclusivity period in the European Union can be reduced to six years if a product no longer meets the criteria for orphan drug designation, in particular if the product is sufficiently profitable so that market exclusivity is no longer justified.

In order for the FDA to grant orphan drug exclusivity to one of our products, the FDA must find that the product is indicated for the treatment of a condition or disease with a patient population of fewer than 200,000 individuals annually in the United States. The FDA may conclude that the condition or disease for which we seek orphan drug exclusivity does

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not meet this standard. Even if we obtain orphan drug exclusivity for a product, that exclusivity may not effectively protect the product from competition because different products can be approved for the same condition. In addition, even after an orphan drug is approved, the FDA can subsequently approve the same product for the same condition if the FDA concludes that the later product is clinically superior in that it is shown to be safer, more effective or makes a major contribution to patient care. Orphan drug exclusivity may also be lost if the FDA or EMA determines that the request for designation was materially defective or if the manufacturer is unable to assure sufficient quantity of the product to meet the needs of the patients with the rare disease or condition.

In 2017, the Congress passed the FDA Reauthorization Act of 2017, or FDARA, which, among other things, codified the FDA’s pre-existing regulatory interpretation, to require that a drug sponsor demonstrate the clinical superiority of an orphan drug that is otherwise the same as a previously approved drug for the same rare disease in order to receive orphan drug exclusivity. Under Omnibus legislation signed by President Trump on December 27, 2020, the requirement for a product to show clinical superiority applies to drugs and biologics that received orphan drug designation before enactment of FDARA in 2017, but have not yet been approved or licensed by the FDA.

The FDA and Congress may further reevaluate the Orphan Drug Act and its regulations and policies. This may be particularly true in light of a decision from the Court of Appeals for the 11th Circuit in September 2021 ( Catalyst Pharms., Inc. v. Becerra ) finding that, for the purpose of determining the scope of exclusivity, the term “same disease or condition” means the designated “rare disease or condition” and could not be interpreted by the FDA to mean the “indication or use.” Thus, the court concluded, orphan drug exclusivity applies to the entire designated disease or condition rather than the “indication or use.” Although there have been legislative proposals to overrule this decision, they have not been enacted into law. On January 23, 2023, the FDA announced that, in matters beyond the scope of that court order, the FDA will continue to apply its existing regulations tying orphan-drug exclusivity to the uses or indications for which the orphan drug was approved. More recently, however, in February 2025, a federal district court fully embraced the reasoning of the Catalyst decision in another decision challenging the scope of orphan drug exclusivity. On April 17, 2025, the FDA appealed this decision to the U.S. Court of Appeals for the D.C. Circuit. We do not know if, when, or how the FDA may change the orphan drug regulations and policies in the future, and it is uncertain how any changes might affect our business. Depending on what changes the FDA may make to its orphan drug regulations and policies, our business could be adversely impacted.

In addition, to obtain orphan drug designation in the European Union, we would need to demonstrate that there exists no satisfactory method of diagnosis, prevention or treatment of the condition in question that has been authorized in the European Union or, if such method exists, the medicinal product will be of significant benefit to those affected by that condition. There is no assurance that we would be able to meet that standard for any of our product candidates. Further, if we do obtain orphan drug designation for a candidate product in the EU, we will not be able to maintain that designation if we are not able to show, to the satisfaction of the EU regulatory authorities, that the product candidate is of significant benefit to patients over available commercial products for the indication in the EU and any additional products that are ahead of our product candidate in clinical development for the indication.

Even if we, or any collaborators we may have, obtain marketing approvals for any product candidates we may develop, the terms of approvals and ongoing regulation of our products could require the substantial expenditure of resources and may limit how we, or they, manufacture and market such products, which could materially impair our ability to generate revenue.

Any product candidate for which we obtain marketing approval, along with the manufacturing processes, post-approval clinical data, labeling, advertising and promotional activities for such medicine, will be subject to continual requirements of and review by the FDA and other regulatory authorities. These requirements include submissions of safety and other post-marketing information and reports, registration and listing requirements, cGMP requirements relating to quality control, quality assurance and corresponding maintenance of records and documents, and requirements regarding the distribution of samples to physicians and recordkeeping. For example, the holder of an approved NDA is obligated to monitor and report adverse events and any failure of a product to meet the specifications in the NDA. The holder of an approved NDA must also submit new or supplemental applications and obtain FDA approval for certain changes to the approved product, product labeling or manufacturing process. Even if marketing approval of a product candidate is granted, the approval may be subject to limitations on the indicated uses for which the medicine may be marketed or to the conditions of approval, or contain requirements for costly post-marketing testing and surveillance to monitor the safety or efficacy of the medicine.

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Accordingly, assuming we, or any collaborators we may have, receive marketing approval for one or more product candidates we may develop, we, and such collaborators, and our and their contract manufacturers will continue to expend time, money and effort in all areas of regulatory compliance, including manufacturing, production, product surveillance and quality control. If we and such collaborators are not able to comply with post-approval regulatory requirements, we and such collaborators could have the marketing approvals for our products withdrawn by regulatory authorities and our, or such collaborators’, ability to market any future products could be limited, which could adversely affect our ability to achieve or sustain profitability. Further, the cost of compliance with post-approval regulations may have a negative effect on our business, operating results, financial condition and prospects. Any government investigation of alleged violations of law could require us to expend significant time and resources in response and could generate negative publicity. The occurrence of any event or penalty described above may inhibit our ability to commercialize any product candidates we may develop and generate revenues.

In addition, later discovery of previously unknown problems with our medicines, manufacturers or manufacturing processes, or failure to comply with regulatory requirements, may yield various results, including:

• restrictions on such medicines, manufacturers or manufacturing processes;

• restrictions on the labeling or marketing of a medicine;

• restrictions on the distribution or use of a medicine;

• requirements to conduct post-marketing clinical trials;

• receipt of warning or untitled letters;

• withdrawal of the medicines from the market;

• refusal to approve pending applications or supplements to approved applications that we submit;

• recall of medicines;

• fines, restitution or disgorgement of profits or revenue;

• suspension or withdrawal of marketing approvals;

• suspension of any ongoing clinical trials;

• refusal to permit the import or export of our medicines;

• product seizure; and

• injunctions or the imposition of civil or criminal penalties.

Additionally, if any product candidates we may develop receive marketing approval, the FDA could require us to adopt risk evaluation and mitigation strategies, or REMS, to ensure that the benefits outweigh its risks, which may include, among other things, a medication guide outlining the risks of the product for distribution to patients and a communication plan to healthcare practitioners. Furthermore, if we or others later identify undesirable side effects caused by our product candidate, several potentially significant negative consequences could result, including:

• regulatory authorities may suspend or withdraw approvals of such product candidate;

• regulatory authorities may require additional warnings on the label;

• we may be required to change the way a product candidate is administered or conduct additional clinical trials;

• we could be sued and held liable for harm caused to patients; and

• our reputation may suffer.

Finally, our ability to develop and market new drug products may be impacted by litigation challenging the FDA’s approval of another company’s drug product. In April 2023, the U.S. District Court for the Northern District of Texas invalidated the approval by the FDA of mifepristone, a drug product which was originally approved in 2000 and whose distribution is governed by various measures adopted under a REMS. The Court of Appeals for the Fifth Circuit declined to order the removal of mifepristone from the market but did hold that plaintiffs were likely to prevail in their claim that changes allowing for expanded access of mifepristone, which the FDA authorized in 2016 and 2021, were arbitrary and capricious. In June 2024, the Supreme Court reversed that decision after unanimously finding that the plaintiffs (anti-abortion doctors and organizations) did not have standing to bring this legal action against the FDA. On October 11, 2024,

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the Attorneys General of three states (Missouri, Idaho and Kansas) filed an amended complaint in the district court in Texas challenging FDA’s actions. On January 16, 2025, the district court agreed to allow these states to file an amended complaint and continue to pursue this challenge. Thereafter, on September 30, 2025, the district court declined to dismiss the case and, instead, transferred it to federal district court in the Eastern District of Missouri. Depending on the outcome of this litigation, our ability to develop new drug product candidates and to maintain approval of existing drug products could be delayed, undermined or subject to protracted litigation.

Disruptions at the FDA and other government agencies from funding cuts, personnel losses, regulatory reform, government shutdowns and other developments could hinder our ability to obtain guidance from the FDA regarding our programs and develop and secure approval of our product candidates in a timely manner, which would negatively impact our business.

The FDA and comparable regulatory agencies in foreign jurisdictions, play an important role in the development of our product candidates by providing guidance on our programs and reviewing our regulatory submissions. If these oversight and review activities are disrupted, then correspondingly our ability to develop and secure timely approval of our product candidates could be impacted in a negative manner.

For example, the loss of FDA leadership and personnel could lead to disruptions and delays in FDA guidance, review and approval of our product candidates. Pursuant to President Trump's E.O. 14210, “Implementing the President’s ‘Department of Government Efficiency’ Workforce Optimization Initiative,” the Secretary of Department of Health and Human Services, or HHS, announced on March 27, 2025, a reorganization and reduction in force across the Department of approximately 20,000 employees (82,000 to 62,000), with FDA’s workforce to decrease by 3,500 full-time employees. Shortly thereafter, thousands of employees at the FDA were fired on April 1, 2025. On July 14, 2025, following litigation reaching the U.S. Supreme Court, the administration began to carry out these layoffs across HHS, including the FDA.

Further, while the FDA’s review of marketing applications and other activities for new drugs and biologics is largely funded through the user fee program established under the Prescription Drug User Fee Act, or PDUFA, it remains unclear how the administration’s reduction in force and budget cuts will impact this program and the ability of the FDA to provide guidance and review our product candidates in a timely manner. For example, while the FDA reduction in force did not reportedly specifically target FDA reviewers, many operations, administrative and policy staff that help support such reviews were affected and those losses could lead to delays in PDUFA reviews and related activities. As of July 15, 2025, there has been at least one report in which the FDA failed to meet a PDUFA goal date for approval of an NDA due to heavy workload and limited resources. In addition, while currently unclear, there is a risk that the reduction in force and budget cutbacks could threaten the integrity of the PDUFA program itself. That is because, for the FDA to obligate user fees collected under PDUFA in the first place, a certain amount of non-user fee appropriations must be spent on the process for the review of applications plus certain other costs during the same fiscal year.

There is also substantial uncertainty as to how regulatory reform measures being implemented by the Trump Administration across the government will impact the FDA and other federal agencies with jurisdiction over our activities. For example, since taking office, President Trump has issued a number of executive orders that could have a significant impact on the manner in which the FDA conducts its operations and engages in regulatory and oversight activities. These include E.O. 14192, “Unleashing Prosperity Through Deregulation,” January 31, 2025; E.O. 14212, “Establishing the President’s Make America Healthy Again Commission,” February 13, 2025; and E.O. 14219, “Ensuring Lawful Governance and Implementing the President’s ‘Department of Government Efficiency’ Deregulatory Initiative,” February 21, 2025. If these or other orders or executive actions impose constraints on the FDA’s ability to engage in oversight and implementation activities in the normal course, our business may be negatively impacted.

Similarly, actions by the U.S. government have significantly disrupted the operations of U.S. government agencies such as the National Institutes of Health, National Science Foundation, Centers for Disease Control and Prevention, and FDA, which have traditionally provided funding for basic research, research and development, and clinical testing. These U.S. government actions have included, among other things, suspending, terminating and withholding of disbursements of funds owed under ongoing contracts, grants, and other financial assistance agreements; declining to continue multi-year research projects for additional annual budget periods; canceling or delaying solicitations for new contract, grant and other financial assistance awards; canceling or delaying proposal evaluation processes and issuance of such new awards; substantially reducing federal agency staff responsible for managing contract and financial assistance programs; eliminating agency information and resources for facilitating research activity; delaying or terminating federal agency procedures for authorizing international transactions; initiating aggressive enforcement actions that may disrupt the operations of major research universities that are significant contributors to life sciences research in the United States, and

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threatening access to federal agency contracts and other funding awards based on companies’ otherwise lawful corporate policies and choice of counsel. These U.S. government actions could, directly or indirectly, significantly disrupt, delay, prevent, or increase the costs of our research and product commercialization programs, including our ability to develop new product candidates, conduct clinical trials, implement research collaborations with other companies or institutions, and obtain approvals to market and sell new products.

In addition, government funding of the SEC and other government agencies on which our operations may rely, including those that fund research and development activities, is subject to the political process, which is inherently fluid and unpredictable. For example, over the last several years, the U.S. government has shut down several times and certain regulatory agencies, such as the FDA and the SEC, have had to furlough critical FDA, SEC and other government employees and stop critical activities. If a prolonged government shutdown occurs, it could significantly impact the ability of the FDA to timely review and process our regulatory submissions and could impact our ability to access the public markets and obtain necessary capital in order to properly capitalize and continue our operations.

Accordingly, if any of the foregoing developments and others impact the ability of the FDA to provide us with guidance regarding our programs or delay the agency’s review and processing of our regulatory submissions, our business would be negatively impacted. Further, any future government shutdown could impact our ability to access the public markets and obtain necessary capital in order to properly capitalize and continue our operations.

Current and future legislation may increase the difficulty and cost for us to obtain reimbursement for any of our product candidates that do receive marketing approval.

In the United States and foreign jurisdictions, there have been a number of legislative and regulatory changes and proposed changes regarding the healthcare system that could prevent or delay marketing approval of our product candidates, restrict or regulate post-approval activities and affect our ability to profitably sell any product candidates for which we obtain marketing approval. We expect that current laws, as well as other healthcare reform measures that may be adopted in the future, may result in more rigorous coverage criteria and in additional downward pressure on the price that we may receive for any approved products. If reimbursement of our products is unavailable or limited in scope, our business could be materially harmed.

In March 2010, President Obama signed into law the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Affordability Reconciliation Act, or collectively the ACA. In addition, other legislative changes have been proposed and adopted since the ACA was enacted. In August 2011, the Budget Control Act of 2011, among other things, created measures for spending reductions by Congress. A Joint Select Committee on Deficit Reduction, tasked with recommending a targeted deficit reduction of at least $1.2 trillion for the years 2013 through 2021, was unable to reach required goals, thereby triggering the legislation’s automatic reduction to several government programs. These changes included aggregate reductions to Medicare payments to providers of up to 2% per fiscal year, which went into effect in April 2013 and will remain in effect through the first half of 2032 under the Coronavirus Aid, Relief, and Economic Security Act, or the CARES Act.

The American Taxpayer Relief Act of 2012, among other things, reduced Medicare payments to several providers and increased the statute of limitations period for the government to recover overpayments to providers from three to five years. These laws may result in additional reductions in Medicare and other healthcare funding and otherwise affect the prices we may obtain for any of our product candidates for which we may obtain regulatory approval or the frequency with which any such product candidate is prescribed or used.

Since enactment of the ACA, there have been, and continue to be, numerous legal challenges and Congressional actions to repeal and replace provisions of the law. For example, with enactment of the Tax Cuts and Jobs Act in 2017, Congress repealed the "individual mandate." The repeal of this provision, which requires most Americans to carry a minimal level of health insurance, became effective in 2019. In June 2021, the U.S. Supreme Court dismissed the judicial challenge to the ACA brought by several states without specifically ruling on the constitutionality of the statute.

Litigation and legislation over the ACA are likely to continue, with unpredictable and uncertain results. During the first Trump Administration, the Congress and administration sought to overturn the ACA and related measures. Shortly after taking office in January 2025, President Trump revoked numerous executive orders issued by President Biden, including at least two executive orders that were designed to further implement the ACA. We anticipate similar efforts to undermine the ACA, and the accompanying uncertainty, for the foreseeable future.

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In the European Union, on December 13, 2021, Regulation No 2021/2282 on Health Technology Assessment, or HTA, amending Directive 2011/24/EU, was adopted. While the HTA entered into force in January 2022, it only began to apply from January 2025 onwards, with a phased implementation depending on the concerned products. The HTA intends to boost cooperation among European Union member states in assessing health technologies, including new medicinal products as well as certain high-risk medical devices, and provide the basis for cooperation at the European Union level for joint clinical assessments in these areas. It will permit European Union member states to use common HTA tools, methodologies, and procedures across the European Union, working together in four main areas, including joint clinical assessment of the innovative health technologies with the highest potential impact for patients, joint scientific consultations whereby developers can seek advice from HTA authorities, identification of emerging health technologies to identify promising technologies early, and continuing voluntary cooperation in other areas. Individual European Union member states will continue to be responsible for assessing non-clinical (e.g., economic, social, ethical) aspects of health technology, and making decisions on pricing and reimbursement.

We expect that these healthcare reforms, as well as other healthcare reform measures that may be adopted in the future, may result in additional reductions in Medicare and other healthcare funding, more rigorous coverage criteria, new payment methodologies and additional downward pressure on the price that we receive for any approved product and/or the level of reimbursement physicians receive for administering any approved product we might bring to market. Reductions in reimbursement levels may negatively impact the prices we receive or the frequency with which our products are prescribed or administered. Any reduction in reimbursement from Medicare or other government programs may result in a similar reduction in payments from private payors. Accordingly, such reforms, if enacted, could have an adverse effect on anticipated revenue from product candidates that we may successfully develop and for which we may obtain marketing approval and may affect our overall financial condition and ability to develop or commercialize product candidates.

The prices of prescription pharmaceuticals in the United States and foreign jurisdictions are subject to considerable legislative and executive actions and could impact the prices we obtain for our products, if and when licensed, as well as impact our ability to find collaborators for our drug discovery programs on commercially acceptable terms.

The prices of prescription pharmaceuticals have been the subject of considerable discussion in the United States. There have been several Congressional inquiries, as well as proposed and enacted state and federal legislation designed to, among other things, bring more transparency to pharmaceutical pricing, review the relationship between pricing and manufacturer patient programs, and reduce the costs of pharmaceuticals under Medicare and Medicaid.

In addition, in October 2020, HHS and the FDA published a final rule allowing states and other entities to develop a Section 804 Importation Program, or SIP, to import certain prescription drugs from Canada into the United States. That regulation was challenged in a lawsuit by the Pharmaceutical Research and Manufacturers of America, or PhRMA, but the case was dismissed by a federal district court in February 2023 after the court found that PhRMA did not have standing to sue HHS. Several states have passed laws allowing for the importation of drugs from Canada and a few states have passed legislation establishing working groups to examine the impact of a state importation program. Several of these states have submitted Section 804 Importation Program proposals to the FDA. In January 2024, the FDA approved Florida's plan for Canadian drug importation. Florida now has authority to import certain drugs for a period of two years once certain conditions are met. Florida will first need to submit a pre-import request for each drug selected for importation, which must be approved by the FDA. Florida will also need to relabel the drugs and perform quality testing of the products to meet FDA standards. On May 21, 2025, the FDA announced that it would offer individual states the opportunity to submit a draft proposal for pre-review and meet with the agency to obtain initial feedback from FDA prior to formally submitting their SIP proposal. The intent of these meetings is to assist states in developing their proposals by further clarifying requirements, enhancing the quality of proposals submitted to the agency and ultimately shortening the review timeline.

Further, on November 20, 2020, HHS finalized a regulation that would eliminate the current safe harbor for Medicare drug rebates and create new safe harbors for beneficiary point-of-sale discounts and pharmacy benefit manager service fees. It originally was set to go into effect on January 1, 2022, but with passage of the IRA has been delayed by Congress until January 1, 2032.

The IRA has implications for Medicare Part D, which is a program available to individuals who are entitled to Medicare Part A or enrolled in Medicare Part B to give them the option of paying a monthly premium for outpatient prescription drug coverage. Among other things, the IRA requires manufacturers of certain drugs to engage in price negotiations with Medicare (beginning in 2026), with prices that can be negotiated subject to a cap; imposes rebates under Medicare Part B and Medicare Part D to penalize price increases that outpace inflation; and replaced the Part D coverage

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gap discount program with a new discounting program in 2025. The IRA permits the Secretary of the HHS to implement many of these provisions through guidance, as opposed to regulation, for the initial years.

Specifically, with respect to price negotiations, Congress authorized Medicare to negotiate lower prices for certain costly single-source drug and biologic products that do not have competing generics or biosimilars and are reimbursed under Medicare Part B and Part D. CMS may negotiate prices for ten high-cost drugs paid for by Medicare Part D starting in 2026, followed by 15 Part D drugs in 2027, 15 Part B or Part D drugs in 2028, and 20 Part B or Part D drugs in 2029 and beyond. This provision applies to drug products that have been approved for at least nine years and biologics that have been licensed for 13 years. Drugs and biologics that have been approved for a single rare disease or condition were originally categorically excluded from price negotiation. With passage of the OBBBA in July 2025, Congress extended this exemption to drugs and biologics with multiple orphan drug designations. With passage of the OBBBA in July 2025, Congress extended this exemption to drugs and biologics with multiple orphan drug designations.

The first cycle of negotiations for the Medicare Drug Price Negotiation Program commenced in the summer of 2023. On August 15, 2024, the HHS published the results of the first Medicare drug price negotiations for ten selected drugs that treat a range of conditions, including diabetes, chronic kidney disease, and rheumatoid arthritis. The prices of these ten drugs became effective January 1, 2026. On January 17, 2025, CMS announced its selection of 15 additional drugs covered by Part D for the second cycle of negotiations. Thereafter, following the change in administrations, CMS issued a public statement on January 29, 2025, declaring that lowering the cost of prescription drugs is a top priority of the new administration and CMS is committed to considering opportunities to bring greater transparency in the negotiation program. The second cycle of negotiations with participating drug companies occurred during 2025, and any negotiated prices for this second set of drugs will be effective starting January 1, 2027.

We would be fully at risk of government action if our products or those of our partners are the subject of Medicare price negotiations. Moreover, given the risk that could be the case, these provisions of the IRA may also further heighten the risk that we would not be able to achieve the expected return on our drug products or full value of our patents protecting our products if prices are set after such products have been on the market for nine years.

Furthermore, these provisions of the IRA may cause some companies to shift their research portfolio and priorities more towards large molecules ( i.e. , biologics such as antibodies) rather than small molecules. Although we do have applications of our technology to biologics, we do not yet have the same validation or value for large molecule discovery as we do for small molecule discovery. Accordingly, if the IRA causes the pharmaceutical industry to pivot investment and portfolio strategy away from small molecule drug discovery and towards biologics, it could have a material adverse effect on the expected value of our drug discovery programs and also on the perceived value of using our software to develop product candidates. In addition, if investment levels and development interest in small molecule therapeutics decreased, it may become more difficult for us to enter into collaborations on commercially acceptable terms, or at all, for our proprietary drug discovery programs. If we are unable to find suitable collaborators and/or partners for our programs, we may be forced to fund and undertake development or commercialization activities on our own for more programs than we would otherwise expect to, or plan for, which could adversely affect our business and financial condition.

On June 6, 2023, Merck & Co., Inc., filed a lawsuit against HHS and CMS asserting that, among other things, the IRA’s Drug Price Negotiation Program for Medicare constitutes an uncompensated taking in violation of the Fifth Amendment of the U.S. Constitution. Subsequently, other parties, including the U.S. Chamber of Commerce and other pharmaceutical companies also filed lawsuits in various courts with similar constitutional claims against HHS and CMS. HHS has generally won substantive disputes in these cases, and various federal district court judges have expressed skepticism regarding the merits of the legal arguments being pursued by the pharmaceutical industry. Certain of these cases are now on appeal, and on October 30, 2024, the Court of Appeals for the Third Circuit heard oral argument in three of these cases. On May 8, 2025, the Third Circuit rejected AstraZeneca’s challenge to the Medicare price negotiation program, finding that the program did not violate the company’s due process rights under the constitution since there is no protected property interest in selling goods to Medicare beneficiaries at a price higher than what the government is willing to pay in reimbursement. We expect that litigation involving these and other provisions of the IRA will continue, with unpredictable and uncertain results.

Further, the legislation subjects drug manufacturers to civil monetary penalties and a potential excise tax for failing to comply with the legislation by offering a price that is not equal to or less than the negotiated “maximum fair price” under the law or for taking price increases that exceed inflation. In addition to the drug price negotiation program, the IRA established inflation rebate programs under Medicare Part B and Part D. These programs require manufacturers to pay rebates to Medicare if they raise their prices for certain Part B and Part D drugs faster than the rate of inflation. On

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December 9, 2024, with issuance of its 2025 Physician Fee Schedule final regulation, CMS finalized its rules governing the IRA inflation rebate programs. The new law also caps Medicare out-of-pocket drug costs at an estimated $2,000 beginning in 2025.

Accordingly, while it is currently unclear how the IRA will be effectuated, we cannot predict with certainty what impact any federal or state health reforms will have on us, but such changes could impose new or more stringent regulatory requirements on our activities or result in reduced reimbursement for approved products, any of which could adversely affect our business, results of operations and financial condition.

More recently, on April 15, 2025, President Trump issued an executive order which directs HHS to take steps to reduce the prices of pharmaceutical products. The new Order repeats many of the proposals advanced during the first Trump Administration, including directing the FDA to streamline and improve its existing drug importation program so as to make it easier for states to obtain approval without sacrificing the safety or quality of drug products. Other provisions of the Order relate to the 340B program. Specifically, one provision calls on the Secretary of HHS to determine the hospital acquisition cost for covered outpatient drugs at hospital outpatient departments and to consider and propose any appropriate adjustments for Medicare payment. The other provision directs HHS to condition grant funding to certain health centers on those centers passing through the 340B discounts they receive on insulin and injectable epinephrine products to patients who meet certain requirements. With respect to the IRA’s Medicare drug pricing program, the Order, among other things, calls for alignment in “the treatment of small molecule prescription drugs with that of biological products, ending the distortion that undermines relative investment in small molecule prescription drugs, coupled with other reforms to prevent any increase in overall costs to Medicare and its beneficiaries.”

Further, on May 12, 2025, President Trump issued an additional executive order calling on pharmaceutical manufacturers to voluntarily reduce the prices of medicines in the United States. The executive order directs the Secretary of HHS to communicate most-favored-nation, or MFN, price targets to pharmaceutical manufacturers to bring prices in line with comparably developed nations. The executive order further provides that if such actions do not lower the costs of pharmaceuticals, the Secretary of HHS would pursue other actions, including proposing a rulemaking that imposes MFN pricing in the United States. Subsequently, on May 20, 2025, HHS indicated that the proposed MFN pricing will apply only to brand products without generic or biosimilar competition and the reference foreign countries will include only those in which the branded product similarly does not have generic or biosimilar competition. Second, HHS indicated that the MFN target price will be the lowest price in a country that is a member of the Organization for Economic Co-operation and Development, or OECD, with a gross domestic product, or GDP, per capita of at least 60% of the U.S. GDP per capita. Based on previous estimates, there are likely at least 22 OECD countries that would satisfy this criterion. The implications of these actions remain unclear and are likely to result in litigation if the administration pursues an MFN regulatory pricing requirement.

On July 31, 2025, the President issued letters to 17 pharmaceutical companies reiterating the requirements of the May 12, 2025 executive order and demanding that such companies extend MFN pricing to Medicaid patients, guarantee MFN pricing for newly-launched drug products, return increased revenues abroad to American patients and provide for direct purchasing at MFN pricing. The letters also urged these companies to stipulate that they will not offer other developed nations better prices for new drugs than the prices offered for such products in the United States. The letters called for engagement with the FDA and CMS within 60 days to implement these changes and threatened to use “every tool in our arsenal” to address what the letter characterized as “abusive drug pricing practices.” Subsequently, the Trump administration has announced deals with nearly all such pharmaceutical companies to reduce the costs of drugs. On February 5, 2026, President Trump launched TrumpRx.gov, a website that directs individuals to pharmaceutical manufacturer websites that are offering price discounts based on the administration’s pricing agreements with pharmaceutical manufacturers.

In December 2025, CMS, through its Center for Medicare and Medicaid Innovation, proposed two five-year pilot programs to implement a “reference pricing” regime for drugs paid for under Medicare for 25% of covered beneficiaries. The programs are referred to as the Global Benchmark for Efficient Drug Pricing Model for Medicare Part B drugs, referred to as GLOBE, which is proposed to go into effect beginning October 1, 2026, and the Guarding U.S. Medicare Against Rising Drug Costs for Medicare Part D drugs, referred to as GUARD, which is proposed to go into effect beginning January 1, 2027. Under the proposed pilot programs, a manufacturer would owe rebates to Medicare if prices for their drugs exceeded the prices paid by other economically comparable reference countries, defined in the proposed regulations as OECD countries with a GDP of $400 billion and a per capita GDP that is at least 60% of the US per capita GDP (an initial list of 19 reference countries is included in the proposed rule).

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The implications and consequences of these actions and subsequent actions by the Trump administration to compel an MFN regulatory pricing requirement in the United States continue to remain unclear and uncertain and could ultimately result in litigation.

At the state level, individual states are increasingly aggressive in passing legislation and implementing regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing. In addition, regional healthcare organizations and individual hospitals are increasingly using bidding procedures to determine what pharmaceutical products and which suppliers will be included in their prescription drug and other healthcare programs. These measures could reduce the ultimate demand for our products, once approved, or put pressure on our product pricing. We expect that additional state and federal healthcare reform measures will be adopted in the future, any of which could limit the amounts that federal and state governments will pay for healthcare products and services, which could result in reduced demand for our product candidates or additional pricing pressures. This may be increasingly true with respect to products approved pursuant to the accelerated approval pathway. State Medicaid programs and other payers are developing strategies and implementing significant coverage barriers, or refusing to cover these products outright, arguing that accelerated approval drugs have insufficient or limited evidence despite meeting the FDA’s standards for accelerated approval.

In the European Union, similar political, economic and regulatory developments may affect our ability to profitably commercialize our product candidates, if approved. In markets outside of the United States and the European Union, reimbursement and healthcare payment systems vary significantly by country, and many countries have instituted price ceilings on specific products and therapies. In many countries, including those of the European Union, the pricing of prescription pharmaceuticals is subject to governmental control and access. In these countries, pricing negotiations with governmental authorities can take considerable time after the receipt of marketing approval for a product. To obtain reimbursement or pricing approval in some countries, we or our collaborators may be required to conduct a clinical trial that compares the cost-effectiveness of our product to other available therapies. If reimbursement is unavailable or limited in scope or amount, or if pricing is set at unsatisfactory levels, our business could be materially harmed.

Compliance with global privacy and data security requirements could result in additional costs and liabilities to us or inhibit our ability to collect and process data globally, and the failure to comply with such requirements could subject us to significant fines and penalties, which may have a material adverse effect on our business, financial condition, or results of operations.

The regulatory framework for the collection, use, safeguarding, sharing, transfer, and other processing of information worldwide is rapidly evolving and is likely to remain uncertain for the foreseeable future. Globally, virtually every jurisdiction in which we operate has established its own data security and privacy frameworks with which we must comply. For example, the collection, use, disclosure, transfer, or other processing of personal data regarding individuals in the European Union, including personal health data and employee data, is subject to the European Union General Data Protection Regulation, or the GDPR, which took effect across all member states of the European Economic Area, or EEA, in May 2018. The GDPR is wide-ranging in scope and imposes numerous requirements on companies that process personal data, including requirements relating to processing health and other sensitive data, obtaining consent of the individuals to whom the personal data relates, providing information to individuals regarding data processing activities, implementing safeguards to protect the security and confidentiality of personal data, providing notification of data breaches, and taking certain measures when engaging third-party processors. The GDPR increases our obligations with respect to any clinical trials conducted in the EEA by expanding the definition of personal data to include coded data and requiring changes to informed consent practices and more detailed notices for clinical trial subjects and investigators. In addition, the GDPR also imposes strict rules on the transfer of personal data to countries outside the European Union, including the United States and, as a result, increases the scrutiny that such rules should apply to transfers of personal data from any clinical trial sites located in the EEA to the United States. In October 2022, President Biden signed an executive order to implement the EU-U.S. Data Privacy Framework, which serves as a replacement to the EU-U.S. Privacy Shield. The European Commission initiated the process to adopt an adequacy decision for the EU-U.S. Data Privacy Framework in December 2022, and the European Commission adopted the adequacy decision on July 10, 2023. The adequacy decision permits companies in the United States who self-certify to the EU-U.S. Data Privacy Framework to rely on it as a valid data transfer mechanism for data transfers from the European Union to the United States. However, some privacy advocacy groups have already suggested that they will be challenging the EU-U.S. Data Privacy Framework. If these challenges are successful, they may not only impact the EU-U.S. Data Privacy Framework, but also further limit the viability of the standard contractual clauses and other data transfer mechanisms. The uncertainty around this issue has the potential to impact our business internationally.

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Following the withdrawal of the United Kingdom from the European Union, the United Kingdom’s Data Protection Act 2018 applies to the processing of personal data that takes place in the United Kingdom and includes parallel obligations to those set forth by GDPR. In relation to data transfers, both the United Kingdom and the European Union have determined, through separate "adequacy" decisions, that data transfers between the two jurisdictions are in compliance with the United Kingdom’s Data Protection Act 2018 and the GDPR, respectively. In October 2023, the United Kingdom and the United States implemented a U.S.-U.K. "data bridge," which functions similarly to the EU-U.S. Data Privacy Framework and provides an additional legal mechanism for companies to transfer data from the United Kingdom to the United States. Any changes or updates to these developments have the potential to impact our business.

The GDPR also permits data protection authorities to require destruction of improperly gathered or used personal information and/or impose substantial fines for violations of the GDPR, which can be up to four percent of global revenues or 20 million Euros, whichever is greater, and confers a private right of action on data subjects and consumer associations to lodge complaints with supervisory authorities, seek judicial remedies, and obtain compensation for damages resulting from violations of the GDPR. In addition, the GDPR provides that European Union member states may make their own further laws and regulations limiting the processing of personal data, including genetic, biometric, or health data.

Given the breadth and depth of changes in data protection obligations, preparing for and complying with the GDPR’s requirements is rigorous and time intensive and requires significant resources and a review of our technologies, systems and practices, as well as those of any third-party collaborators, service providers, contractors, or consultants that process or transfer personal data collected in the European Union. The GDPR and other changes in laws or regulations associated with the enhanced protection of certain types of sensitive data, such as healthcare data or other personal information, could require us to change our business practices and put in place additional compliance mechanisms, may interrupt or delay our development, regulatory and commercialization activities and increase our cost of doing business, and could lead to government enforcement actions, private litigation, and significant fines and penalties against us, and could have a material adverse effect on our business, financial condition, or results of operations.

In addition, the EU Data Act, which became effective on September 12, 2025, imposes certain data and cloud service interoperability and switching obligations to enable users to switch between cloud service providers without undue delay or cost, as well as certain requirements concerning cross-border international transfers of, and governmental access to, non-personal data outside the EEA. We may be required to provide more flexible termination rights to certain software subscription customers in the European Union, including on multi-year contracts, which could have an adverse effect on our results of operations if we have to account for the increased flexibility in such contracts. We may also incur costs to comply with the EU Data Act, and we may become subject to substantial fines or civil litigation for noncompliance. Depending on how the EU Data Act and any similar laws are implemented and interpreted, we may have to further adapt our business practices, services and contractual arrangements to comply with such obligations.

Similar privacy and data security requirements are either in place or underway in the United States. There are a broad variety of data protection laws that may be applicable to our activities, and a range of enforcement agencies at both the state and federal levels that can review companies for privacy and data security concerns. The Federal Trade Commission, or FTC, and state Attorneys General are aggressive in reviewing privacy and data security protections for consumers. For example, the FTC has been particularly focused on the unpermitted processing of health and genetic data through its enforcement actions and is expanding the types of privacy violations that it interprets to be “unfair” under Section 5 of the Federal Trade Commission Act, as well as the types of activities it views to trigger the Health Breach Notification Rule (which the FTC also has the authority to enforce). The agency is also in the process of developing rules related to commercial surveillance and data security that may impact our business. We will need to account for the FTC’s evolving rules and guidance for proper privacy and data security practices in order to mitigate our risk for a potential enforcement action, which may be costly. If we are subject to a potential FTC enforcement action, we may be subject to a settlement order that requires us to adhere to very specific privacy and data security practices, which may impact our business. We may also be required to pay fines as part of a settlement (depending on the nature of the alleged violations). If we violate any consent order that we reach with the FTC, we may be subject to additional fines and compliance requirements.

States are also active in creating specific rules relating to the processing of personal information. For example, the California Consumer Privacy Act, or CCPA, which went into effect on January 1, 2020, is creating similar risks and obligations as those created by GDPR. Because of this, we may need to engage in additional activities (e.g., data mapping) to identify the personal information we are collecting and the purposes for which such information is collected. In addition, we will need to ensure that our policies recognize the rights granted to consumers (as that phrase is broadly defined in the CCPA and can include business contact information), including granting consumers the right to opt-out of the sale of their

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personal information. Many other states are considering similar legislation. The California Privacy Rights Act, or the CPRA, which went into effect on January 1, 2023, significantly expanded the CCPA to incorporate additional GDPR-like provisions including requiring that the use, retention, and sharing of personal information of California residents be reasonably necessary and proportionate to the purposes of collection or processing, granting additional protections for sensitive personal information, and requiring greater disclosures related to notice to residents regarding retention of information.

In addition to California, a number of other states have passed comprehensive privacy laws similar to the CCPA and CPRA. These laws are either in effect or will go into effect sometime before the end of 2026. Like the CCPA and CPRA, these laws create obligations related to the processing of personal information, as well as special obligations for the processing of “sensitive” data (which includes health data in some cases). Some of the provisions of these laws may apply to our business activities. There are also states that are considering or have already passed comprehensive privacy laws that will go into effect in the near future. There are also states that are specifically regulating health information that may affect our business. For example, Washington state passed a health privacy law that will regulate the collection and sharing of health information, and the law also has a private right of action, which further increases the relevant compliance risk. These laws may impact our business activities, including our identification of research subjects, relationships with business partners and ultimately the marketing and distribution of our products.

Plaintiffs’ lawyers are also increasingly using privacy-related statutes at both the state and federal level to bring lawsuits against companies for their data-related practices. In particular, there have been a significant number of cases filed against companies for their use of pixels and other web trackers. These cases often allege violations of the California Invasion of Privacy Act and other state laws regulating wiretapping, as well as the federal Video Privacy Protection Act. The rise in these types of lawsuits creates potential risk for our business.

Even if we are not determined to have violated these laws, investigations into these issues typically require the expenditure of significant resources and generate negative publicity, which could harm our reputation and our business.

We, and the collaborators who use our computational platform, may be subject to applicable anti-kickback, fraud and abuse, false claims, transparency, health information privacy and security, and other healthcare laws and regulations. Failure to comply with such laws and regulations, may result in substantial penalties.

We, and the collaborators who use our computational platform, may be subject to broadly applicable healthcare laws and regulations that may constrain the business or financial arrangements and relationships through which we market, sell, and distribute our software solutions and any products for which we obtain marketing approval. Such healthcare laws and regulations include, but are not limited to, the federal health care Anti-Kickback Statute; federal civil and criminal false claims laws, such as the federal False Claims Act; the federal Health Insurance Portability and Accountability Act of 1996, or HIPAA; the Federal Food, Drug, and Cosmetic Act; the federal Physician Payments Sunshine Act; and analogous state and foreign laws and regulations, such as state anti-kickback and false claims laws and transparency laws.

Efforts to ensure that our business arrangements with third parties will comply with applicable healthcare laws and regulations will involve substantial costs. It is possible that governmental authorities will conclude that our business practices may not comply with current or future statutes, regulations, or case law involving applicable fraud and abuse or other healthcare laws and regulations. Violations of applicable healthcare laws and regulations may result in significant civil, criminal, and administrative penalties, damages, disgorgement, fines, imprisonment, exclusion of products from government funded healthcare programs, such as Medicare and Medicaid, additional reporting requirements, and/or oversight if a corporate integrity agreement or similar agreement is executed to resolve allegations of non-compliance with these laws and the curtailment or restructuring of operations. In addition, violations may also result in reputational harm, diminished profits, and future earnings.

We are subject to anti-corruption laws, as well as export control laws, customs laws, sanctions laws, and other laws governing our operations. If we fail to comply with these laws, we could be subject to civil or criminal penalties, other remedial measures, and legal expenses, be precluded from developing, manufacturing, and selling certain products outside the United States or be required to develop and implement costly compliance programs, which could adversely affect our business, results of operations and financial condition.

Our operations are subject to anti-corruption laws, including the U.K. Bribery Act 2010, or Bribery Act, the U.S. Foreign Corrupt Practices Act, or FCPA, and other anti-corruption laws that apply in countries where we do business and may do business in the future. The Bribery Act, FCPA, and these other laws generally prohibit us, our officers, and our

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employees and intermediaries from bribing, being bribed, or making other prohibited payments to government officials or other persons to obtain or retain business or gain some other business advantage. Compliance with the FCPA, in particular, is expensive and difficult, particularly in countries in which corruption is a recognized problem. In addition, the FCPA presents particular challenges in the biopharmaceutical industry, because, in many countries, hospitals are operated by the government, and doctors and other hospital employees are considered foreign officials. Certain payments to hospitals in connection with clinical trials and other work have been deemed to be improper payments to government officials and have led to FCPA enforcement actions.

We may in the future operate in jurisdictions that pose a high risk of potential Bribery Act or FCPA violations, and we may participate in collaborations and relationships with third parties whose actions could potentially subject us to liability under the Bribery Act, FCPA, or local anti-corruption laws. In addition, we cannot predict the nature, scope or effect of future regulatory requirements to which our international operations might be subject or the manner in which existing laws might be administered or interpreted. If we further expand our operations outside of the United States, we will need to dedicate additional resources to comply with numerous laws and regulations in each jurisdiction in which we plan to operate.

We are also subject to other laws and regulations governing our international operations, including regulations administered by the governments of the United Kingdom and the United States, and authorities in the European Union, including applicable export control regulations, economic sanctions on countries and persons, customs requirements, and currency exchange regulations, collectively referred to as the Trade Control laws. In addition, various laws, regulations, and executive orders also restrict the use and dissemination outside of the United States, or the sharing with certain non-U.S. nationals, of information classified for national security purposes, as well as certain products and technical data relating to those products. If we expand our presence outside of the United States, it will require us to dedicate additional resources to comply with these laws, and these laws may preclude us from developing, manufacturing, or selling certain products and product candidates outside of the United States, which could limit our growth potential and increase our development costs.

We will also need to carefully navigate the current administration’s implementation of the FCPA and related statutes. On February 10, 2025, President Trump issued an executive order directing the Attorney General to review the guidelines and policies governing FCPA investigations and enforcement actions. Per the executive order, this review will result in new Department of Justice FCPA guidelines intended to enhance American economic competitiveness and to safeguard national security interests. During the 180-day review period, any new FCPA investigations and enforcement actions are to be suspended absent authorization from the Attorney General, and all existing FCPA investigations and enforcement actions will be reviewed. Additionally, after the Attorney General issues revised guidelines, the executive order directs her to assess whether “remedial measures” related to past FCPA actions are warranted.

There is no assurance that we will be completely effective in ensuring our compliance with all applicable anti-corruption laws, including the Bribery Act, the FCPA, or other legal requirements, including Trade Control laws. If we are not in compliance with the Bribery Act, the FCPA, and other anti-corruption laws or Trade Control laws, we may be subject to criminal and civil penalties, disgorgement and other sanctions and remedial measures, and legal expenses, which could have an adverse impact on our business, financial condition, results of operations, and liquidity. The U.S. Securities and Exchange Commission, or SEC, also may suspend or bar issuers from trading securities on U.S. exchanges for violations of the FCPA’s accounting provisions. Any investigation of any potential violations of the Bribery Act, the FCPA, other anti-corruption laws or Trade Control laws by the United Kingdom, U.S., or other authorities could also have an adverse impact on our reputation, our business, results of operations, and financial condition.

Changes in and uncertainty surrounding U.S. and international trade policies, particularly with respect to China, may adversely impact our business and operating results.

In the spring of 2025, the U.S. government initiated a series of tariff-related actions against U.S. trading partners. On April 2, 2025, President Trump issued an executive order announcing a “baseline” reciprocal tariff of 10% on all U.S. trading partners effective April 5, 2025, and higher individualized reciprocal tariffs on 57 countries (with certain product exemptions for pharmaceutical-related products, among others). Previously, the Trump administration had imposed a 25% tariff on Canada and Mexico for goods not covered by the United States-Mexico-Canada Agreement and tariffs due to drug trafficking equaling 20% on imports from China. In response, several countries threatened retaliatory measures, including Canada and China, which then imposed retaliatory tariffs. Prior to when the country-specific reciprocal tariffs were scheduled to take effect, the Trump administration delayed the effective date of such tariffs for all countries except China to August 1, 2025. Later, the U.S. and China reached a framework agreement that ultimately resulted in the suspension of

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the higher reciprocal tariffs on China until November 10, 2025. Shortly before that expiration date, the U.S. and China reached a one-year agreement with an expiration of November 10, 2026, that includes the continued suspension of the heightened reciprocal tariffs on China and delayed enforcement of new U.S. export rules targeting affiliates of blacklisted firms.

Since the April 2025 reciprocal tariffs announcement, the European Union, Japan, South Korea, Switzerland and the United Kingdom, among others, have reached deals with the U.S. that include reduced tariff rates to varying levels and other measures. On July 31, 2025, President Trump issued an executive order detailing new reciprocal tariff rates for individual countries that took effect on August 7, 2025. The deals with the European Union, Japan, South Korea, Switzerland (and Liechtenstein), the United Kingdom and others cap pharmaceutical tariffs at 15%. In addition, an agreement with Malaysia provides a zero percent tariff exemption for pharmaceutical products that are not patented in the U.S. and are used in pharmaceutical applications, and an agreement with Switzerland and Liechtenstein caps tariffs on pharmaceuticals imported from those two countries at 15%. Finally, an agreement with Taiwan concluded on January 15, 2026, eliminates tariffs on generic pharmaceuticals and their active ingredients imported from Taiwan.

The reciprocal tariffs and the fentanyl tariffs were imposed pursuant to the International Emergency Economic Powers Act, or the IEEPA. These tariffs were found to be unconstitutional by multiple federal courts in the spring and summer of 2025. On February 20, 2026, the U.S. Supreme Court held that the IEEPA does not authorize the U.S. President to impose tariffs, invalidating both the reciprocal tariffs and the drug trafficking tariffs. Shortly thereafter, President Trump issued a new executive order revoking the IEEPA tariffs and Customs and Border Protection ceased collecting the tariffs on February 24, 2026. At the same time, however, the Trump administration imposed a new 10% global tariff under Section 122 of the Trade Act of 1974, effective February 24, 2026. Pursuant to the statute, absent an extension by Congress, these tariffs will expire in 150 days on July 24, 2026. For those countries that have concluded trade deals with the U.S., the tariff rates agreed to, including with regard to pharmaceuticals and pharmaceutical ingredients, have now reverted to 10% until July 24, 2026. Like the IEEPA tariffs, pharmaceuticals and pharmaceutical ingredients are exempt from the Section 122 tariffs along with a list of other products. The Trump administration has announced that it also plans to initiate new investigations on “most major trading partners” under Section 301 of the same act, which will likely lead to additional tariffs.

Neither the U.S. Supreme Court’s decision nor the Executive Order revoking the IEEPA tariffs addressed refunds, leaving the issue to renewed proceedings before the U.S. Court of International Trade, where importers may need to pursue administrative remedies and/or litigation amid continued uncertainty. Sustained uncertainty about, or the further escalation of, trade and political tensions between the United States and China could result in a disadvantageous research and manufacturing environment in China, particularly for U.S. based companies, including retaliatory restrictions that hinder or potentially inhibit our ability to rely on CMOs and other service providers that operate in China.

Separately, in April 2025, the U.S. Department of Commerce initiated an investigation under Section 232 of the Trade Expansion Act of 1962 into the impact on U.S. national security of the imports of pharmaceuticals and pharmaceutical ingredients, including finished drug products, medical countermeasures, critical inputs such as active pharmaceutical ingredients, and key starting materials, and derivative products of those items. On September 25, 2025, via a post on Truth Social, President Trump announced that, beginning October 1, 2025, all branded or patented drugs imported in the U.S. would face a 100% tariff. At the same time, Trump indicated that these tariffs could be avoided by building pharmaceutical manufacturing facilities in the U.S. Thereafter, Trump delayed the October 1, 2025 effective date of the tariffs on branded or patented pharmaceutical products announcing that the Trump administration had now “begun preparing” tariffs on manufacturers that do not build in the U.S. or enter into a most-favored-nation drug pricing agreement with the Trump administration. A host of other U.S. tariff actions remain possible, including an additional 25% tariff on products from countries that do business with Iran or Cuba.

As a result of changes in tariffs that have been announced and/or implemented, and the underlying uncertainty currently surrounding international trade, we could experience a negative impact to our costs of materials and production processes, and supply chain disruptions and delays as a result of any new tariff policies or trade restrictions. If we are unable to obtain necessary raw materials or product components in sufficient quantity and in a timely manner due to disruptions in the global supply chain caused by macroeconomic events and conditions, the development, testing and clinical trials of our product candidates may be delayed or infeasible, and regulatory approval or commercial launch of any resulting product may be delayed or not obtained, which could significantly harm our business. We cannot yet predict the effect of the recently imposed U.S. tariffs on imports, or the extent to which other countries will impose quotas, duties, tariffs, taxes or other similar restrictions upon imports or exports in the future, nor can we predict future trade policy or the terms of any renegotiated trade agreements and their impact on our business.

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Further, some of our manufacturers and suppliers are located in China. Trade tensions and conflicts between the United States and China have been escalated in recent years and, as such, we are exposed to the possibility of product supply disruption and increased costs and expenses in the event of changes to the laws, rules, regulations and policies of the governments of the United States or China, or due to geopolitical unrest and unstable economic conditions. Certain Chinese biotechnology companies may become subject to trade restrictions, sanctions, other regulatory requirements or proposed legislation by the U.S. government, which could restrict or even prohibit our ability to work with such entities, thereby potentially disrupting their supply of material to us. For example, in February 2024, U.S. lawmakers called for investigations into and the imposition of possible economic sanctions against Chinese biotechnology companies WuXi AppTec and WuXi Biologics, or collectively WuXi, over alleged ties to the Chinese military.

In December 2025, as part of the National Defense Authorization Act for FY 2026, President Trump signed into law the BIOSECURE Act, which prohibits, subject to limited exceptions, the direct or indirect use of U.S. federal government contract, grant, and loan funds for purchasing biotechnology equipment and services from certain Chinese biotechnology companies of concern, or BCCs. Under the BIOSECURE Act, U.S. government agencies cannot (i) buy or obtain biotechnology equipment or services provided by a BCC, (ii) enter into, extend, or renew a contract with any entity using biotechnology equipment or services provided by a BCC to perform a government contract, or (iii) expend loan or grant funds for biotechnology equipment or services provided by a BCC, whether directly or through a loan or grant recipient. Instead of specifying particular Chinese entities as BCCs, the BIOSECURE Act treats any biotechnology companies that have been identified on the so-called 1260H List by the U.S. Department of Defense as Chinese Military Companies Operating in the United States as BCCs. The legislation allows for other biotechnology companies to be added to the federal funding prohibitions at a later time. On December 18, 2025, the Chairs of multiple Senate and House committees, including the House Select Committee on China, sent a letter to the Department of Defense recommending that WuXi be added to the 1260H list, which would make it a BCC. The 1260H list was updated by the Department of Defense in January 2024 and January 2025. On February 13, 2026, the Department published an updated list, which included WuXi, but then abruptly withdrew the list. The implications of this action remain unclear.

Any unfavorable government policies on international trade, such as export controls, capital controls or tariffs, may increase the cost of manufacturing our product candidates, affect the demand for our product candidates (if and when approved), the competitive position of our product candidates, and import or export of raw materials and finished product candidates used in our preclinical studies and clinical trials, particularly with respect to any product candidates and materials that we import from China. We cannot yet predict the effect of the U.S. tariffs on imports, or the extent to which other countries, in particular, China, will impose and maintain quotas, duties, tariffs, taxes or other similar restrictions upon imports or exports in the future, nor can we predict future trade policy or the terms of any renegotiated trade agreements and their impact on our business.

Our employees, independent contractors, consultants, and vendors may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements and insider trading laws, which could cause significant liability for us and harm our reputation.

We are exposed to the risk of fraud or other misconduct by our employees, independent contractors, consultants, and vendors. Misconduct by these partners could include intentional failures to comply with FDA regulations or similar regulations of comparable foreign regulatory authorities, provide accurate information to the FDA or comparable foreign regulatory authorities, comply with manufacturing standards, comply with federal and state healthcare fraud and abuse laws and regulations and similar laws and regulations established and enforced by comparable foreign regulatory authorities, report financial information or data accurately, or disclose unauthorized activities to us. Employee misconduct could also involve the improper use of information obtained in the course of clinical trials, which could result in regulatory sanctions and serious harm to our reputation. This could include violations of HIPAA, other U.S. federal and state law, and requirements of non-U.S. jurisdictions, including the European Union Data Protection Directive. We are also exposed to risks in connection with any insider trading violations by employees or others affiliated with us. It is not always possible to identify and deter employee misconduct, and the precautions we take to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to be in compliance with such laws, standards, regulations, guidance, or codes of conduct. Furthermore, our employees may, from time to time, bring lawsuits against us for employment issues, including injury, discrimination, wage and hour disputes, sexual harassment, hostile work environment, or other employment issues. If any such actions are instituted against us, and we are not successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business and results of operations, including the imposition of significant fines or other sanctions.

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Our internal information technology systems, or those of our third-party vendors, contractors, or consultants, may fail or suffer security breaches, loss or leakage of data, and other disruptions, which could result in a material disruption of our services, compromise sensitive information related to our business, or prevent us from accessing critical information, potentially exposing us to liability or otherwise adversely affecting our business.

We are increasingly dependent upon information technology systems, infrastructure, and data to operate our business. In the ordinary course of business, we collect, store, and transmit confidential information (including but not limited to intellectual property, proprietary business information, and personal information). It is critical that we do so in a secure manner to maintain the confidentiality and integrity of such confidential information. We also have outsourced elements of our operations to third parties, and as a result we manage a number of third-party vendors and other contractors and consultants who have access to our confidential information.

Despite the implementation of security measures, given the size and complexity of our internal information technology systems and those of our third-party vendors and other contractors and consultants, and the increasing amounts of confidential information that they maintain, our information technology systems are potentially vulnerable to breakdown or other damage or interruption from service interruptions, system malfunction, natural disasters, terrorism, war, and telecommunication and electrical failures, as well as security breaches from inadvertent or intentional actions by our employees, third-party vendors, contractors, consultants, business partners, and/or other third parties, or from cyber-attacks by malicious third parties (including the deployment of harmful malware, ransomware, denial-of-service attacks, social engineering, and other means to affect service reliability and threaten the confidentiality, integrity, and availability of information), which may compromise our system infrastructure, or that of our third-party vendors and other contractors and consultants or lead to data leakage. The risk of a security breach or disruption, particularly through cyber-attacks or cyber intrusion, including by computer hackers, foreign governments, and cyber terrorists, has generally increased as the number, intensity, and sophistication of attempted attacks and intrusions from around the world have increased. We may not be able to anticipate all types of security threats, and we may not be able to implement preventive measures that are effective against all such security threats. For example, third parties have in the past and may in the future illegally pirate our software and make that software publicly available on peer-to-peer file sharing networks or otherwise. The techniques used by cyber criminals change frequently, may not be recognized until launched, and can originate from a wide variety of sources, including outside groups such as external service providers, organized crime affiliates, terrorist organizations, or hostile foreign governments or agencies. To the extent that any disruption or security breach were to result in a loss of, or damage to, our data or applications, or those of our third-party vendors and other contractors and consultants, or inappropriate disclosure of confidential or proprietary information, we could incur liability and reputational damage and the further development and commercialization of our software could be delayed. The costs related to significant security breaches or disruptions could be material and exceed the limits of the cybersecurity insurance we maintain against such risks. If the information technology systems of our third-party vendors and other contractors and consultants become subject to disruptions or security breaches, we may have insufficient recourse against such third parties and we may have to expend significant resources to mitigate the impact of such an event, and to develop and implement protections to prevent future events of this nature from occurring.

While we have not experienced any significant system failure, accident, or security breach to date, and believe that our data protection efforts and our investment in information technology reduce the likelihood of such incidents in the future, we cannot assure you that our data protection efforts and our investment in information technology will prevent significant breakdowns, data leakages, breaches in our systems, or those of our third-party vendors and other contractors and consultants, or other cyber incidents that could have a material adverse effect upon our reputation, business, operations, or financial condition. For example, if such an event were to occur and cause interruptions in our operations, or those of our third-party vendors and other contractors and consultants, it could result in a material disruption of our programs and the development of our services and technologies could be delayed. Furthermore, significant disruptions of our internal information technology systems or those of our third-party vendors and other contractors and consultants, or security breaches could result in the loss, misappropriation, and/or unauthorized access, use, or disclosure of, or the prevention of access to, confidential information (including trade secrets or other intellectual property, proprietary business information, and personal information), which could result in financial, legal, business, and reputational harm to us. For example, any such event that leads to unauthorized access, use, or disclosure of personal information, including personal information regarding our customers or employees, could harm our reputation directly, compel us to comply with federal and/or state breach notification laws and foreign law equivalents, subject us to mandatory corrective action, and otherwise subject us to liability under laws and regulations that protect the privacy and security of personal information, which could result in significant legal and financial exposure and reputational damages that could potentially have an adverse effect on our business. Further, sophisticated cyber attackers (including foreign adversaries engaged in industrial espionage) are skilled at adapting to existing security technology and developing new methods of gaining access to organizations’ sensitive business data, which could result in the loss of sensitive information, including trade secrets. For example, attackers have

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used artificial intelligence and machine learning to launch more automated, targeted and coordinated attacks against targets. Additionally, actual, potential, or anticipated attacks may cause us to incur increasing costs, including costs to deploy additional personnel and protection technologies, train employees, and engage third-party experts and consultants.

Climate change-related risks and uncertainties and legal or regulatory responses to climate change could negatively impact our business, financial condition, results of operations, prospects and reputation.

We are subject to increasing climate-related risks and uncertainties, many of which are outside of our control. Climate change may result in more frequent severe weather events, potential changes in precipitation patterns, and extreme variability in weather patterns, which can disrupt our operations as well as those of our vendors, suppliers, and collaborators.

Climate-related macroeconomic trends, including the transition to a lower carbon economy, the effects of carbon pricing, changes in public sentiment, and the potential enactment of climate-related rules and regulations, continue to evolve and may increase our legal, compliance and business costs. Further, increases in climate-related litigation instituted against companies, the cost of climate-related insurance premiums, and the implementation of a more robust business continuity plan and a disaster recovery plan could increase the costs necessary to maintain our operations or achieve any sustainability commitments we may make, which could harm our business.

We annually assess the impacts of our operations and of our customers on the climate. The execution and achievement of any future commitments that we may make or of any goals that we may set relating to climate change are subject to risks and uncertainties. Given the focus on sustainable investing and corporate sustainability, if we fail to adopt policies and practices to enhance environmental initiatives, our reputation and our customer and stakeholder relationships could be negatively impacted, which may make it more difficult for us to compete effectively or to gain access to financing on acceptable terms when needed, which would negatively affect our business, financial condition, results of operations, prospects, and reputation.

Risks Related to Employee Matters and Managing Growth

Our future success depends on our ability to retain key executives and to attract, retain, and motivate qualified personnel.

We are highly dependent on the research and development, clinical, financial, operational, scientific, software engineering, and other business expertise of our executive officers, as well as the other principal members of our management, scientific, clinical, and software engineering teams. Although we have entered into employment agreements with our executive officers, each of them may terminate their employment with us at any time. We do not maintain “key person” insurance for any of our executives or other employees.

The loss of the services of our executive officers or other key employees could impede the achievement of our development and sales goals in our software business and the achievement of our research, development, and commercialization objectives in our drug discovery business. In either case, the loss of the services of our executive officers or other key employees could seriously harm our ability to successfully implement our business strategy. Furthermore, replacing executive officers and key employees may be difficult and may take an extended period of time because of the limited number of individuals with the breadth of skills and experience required to successfully develop, gain regulatory approval of, and commercialize products in the life sciences industry.

Recruiting and retaining qualified scientific, clinical, manufacturing, accounting, legal, and sales and marketing personnel, as well as software engineers and computational chemists, will also be critical to our success. In the technology industry, there is substantial and continuous competition for engineers with high levels of expertise in designing, developing, and managing software and related services, as well as competition for sales executives, data scientists, and operations personnel. Competition to hire these individuals is intense, and we may be unable to hire, train, retain, or motivate these key personnel on acceptable terms given the competition among numerous biopharmaceutical and technology companies for similar personnel. We also experience competition for the hiring of scientific and clinical personnel from universities and research institutions. In addition, we rely on consultants and advisors to assist us in formulating our research and development and commercialization strategy and advancing our computational platform. Our consultants and advisors may be employed by employers other than us and may have commitments under consulting or advisory contracts with other entities that may limit their availability to us. Our reduction in workforce could impact our ability to recruit and retain highly qualified personnel. If we are unable to continue to attract and retain highly qualified personnel, our ability to pursue our growth strategy will be limited and our business would be adversely affected.

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We are pursuing multiple business strategies and may expand our development and regulatory capabilities, and as a result, we may encounter difficulties in managing our multiple business units and our growth, which could disrupt our operations.

Currently, we are pursuing multiple business strategies simultaneously, including activities in research and development, software sales, and collaborative and proprietary drug discovery. We believe pursuing these multiple business strategies offers financial and operational synergies, but these diversified operations place increased demands on our limited resources. Furthermore, we have recently experienced, and we expect to continue to experience, significant growth in the scope of our operations. To manage our multiple business units and our ongoing and anticipated future growth, we must continue to implement and improve our managerial, operational and financial systems, expand our facilities, and continue to recruit and train additional qualified personnel. Due to our limited financial resources and our management team’s limited attention and limited experience in managing a company with such ongoing and anticipated growth, we may not be able to effectively manage our multiple business units and the expansion of our operations or recruit and train additional qualified personnel. The expansion of our operations has led to and may continue to lead to significant costs and may divert our management and business development resources. Our management, personnel, and systems may not be adequate to support this future growth. Any inability to manage our multiple business units and growth could delay the execution of our business plans or disrupt our operations and the synergies we believe currently exist between our business units. In addition, adverse developments in one of these business units may disrupt these synergies.

Risks Related to Ownership of Our Common Stock

Our executive officers, directors, and principal stockholders, if they choose to act together, have the ability to influence all matters submitted to stockholders for approval.

As of April 23, 2026, our executive officers and directors and our stockholders who beneficially owned more than 5% of our outstanding common stock, in the aggregate, beneficially owned shares representing approximately 39.2% of our common stock and all of our limited common stock, or, if the holder of our limited common stock exercised its right to convert each share of its limited common stock for one share of our common stock, approximately 46.7% of our common stock. As a result, if these stockholders were to choose to act together, they would be able to influence all matters submitted to our stockholders for approval, as well as our management and affairs. For example, these persons, if they choose to act together, would influence the election of directors and approval of any merger, consolidation, or sale of all or substantially all of our assets.

This concentration of ownership control may:

• delay, defer, or prevent a change in control;

• entrench our management and board of directors; or

• delay or prevent a merger, consolidation, takeover, or other business combination involving us that other stockholders may desire.

This concentration of ownership may also adversely affect the market price of our common stock.

The price of our common stock is volatile and fluctuates substantially, which could result in substantial losses for our stockholders.

Our stock price has been, and is likely to continue to be, volatile. Since our initial public offering in February 2020 and through April 23, 2026, the intraday price of our common stock has fluctuated from a low of $10.94 to a high of $117.00. As a result of volatility, our stockholders may not be able to sell their common stock at or above the price paid for the shares. The market price for our common stock may be influenced by many factors, including:

• our investment in, and the success of, our software solutions;

• the success of our research and development efforts for our proprietary drug discovery programs;

• initiation and progress of preclinical studies and clinical trials for any product candidates that we may develop;

• results of or developments in preclinical studies and clinical trials of any product candidates we may develop or those of our competitors or potential collaborators;

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• the success of our drug discovery collaborators and any milestone or other payments we receive from such collaborators;

• the success of competitive products or technologies;

• regulatory or legal developments in the United States and other countries;

• the recruitment or departure of key personnel;

• variations in our financial results or the financial results of companies that are perceived to be similar to us;

• guidance or announcements by us with respect to our anticipated financial or operational performance;

• sales of common stock by us, our executive officers, directors or principal stockholders, or others, or the anticipation of such sales;

• equity or debt financing;

• market conditions in the biopharmaceutical sector;

• general economic, industry, and market conditions;

• the societal and economic impact of public health epidemics; and

• the other factors described in this "Risk Factors" section.

In the past, following periods of volatility in the market price of a company’s securities, securities class-action litigation has often been instituted against that company. Any lawsuit to which we are a party, with or without merit, may result in an unfavorable judgment. We also may decide to settle lawsuits on unfavorable terms. Any such negative outcome could result in payments of substantial damages or fines, damage to our reputation, or adverse changes to our offerings or business practices. Such litigation may also cause us to incur other substantial costs to defend such claims and divert management’s attention and resources.

Our actual operating results may differ significantly from our guidance.

We have released, and may in the future release, guidance in our annual or quarterly earnings conference calls or releases, or otherwise, regarding our future performance that represents our management’s estimates as of the date of such guidance. Our guidance, which includes forward-looking statements, has been and will be based on projections prepared by our management. Neither our registered public accountants nor any other independent expert or outside party compiles or examines the projections. Accordingly, no such person expresses any opinion or any other form of assurance with respect to the projections.

Projections are based upon a number of assumptions and estimates that, while presented with numerical specificity, are inherently subject to significant business, economic, and competitive uncertainties and contingencies, many of which are beyond our control and are based upon specific assumptions with respect to future business decisions, some of which will change. The principal reason that we have released, and would continue to release, guidance is to provide a basis for our management to discuss our business outlook with analysts and investors. We do not accept any responsibility for any projections or reports published by any such third parties.

Guidance is necessarily speculative in nature, and it can be expected that some or all of the assumptions underlying any guidance furnished by us will not materialize or will vary significantly from actual results. Accordingly, our guidance is only an estimate of what management believes is realizable as of the date of release. Our actual results have, and may in the future, vary from our guidance and the variations may be material.

We and our collaborators may not achieve projected discovery and development milestones and other anticipated key events in the time frames that we or they announce, which could have an adverse impact on our business and could cause our stock price to decline.

From time to time, we expect that we will make public statements regarding the expected timing of certain milestones and key events, such as the commencement and completion of preclinical and IND-enabling studies and clinical trials in our proprietary drug discovery programs as well as developments and milestones under our collaborations. For example, Structure Therapeutics has also made public statements regarding its expectations for the development of programs under collaboration with us, and Structure Therapeutics and other collaborators may in the future make additional

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statements about their goals and expectations related to collaborations with us. The actual timing of these events can vary dramatically due to a number of factors such as delays or failures in our or our current and future collaborators’ drug discovery and development programs, the amount of time, effort, and resources committed by us and our current and future collaborators, and the numerous uncertainties inherent in the development of drugs. As a result, there can be no assurance that our or our current and future collaborators’ programs will advance or be completed in the time frames we or they announce or expect. If we or any collaborators fail to achieve one or more of these milestones or other key events as planned, our business could be materially adversely affected and the price of our common stock could decline.

If securities analysts do not publish or cease publishing research or reports or publish misleading, inaccurate or unfavorable research about our business or if they publish negative evaluations of our stock, the price and trading volume of our stock could decline.

The market price and trading volume for our common stock relies, in part, on the research and reports that industry or financial analysts publish about us or our business. We do not have control over these analysts. There can be no assurance that existing analysts will continue to cover us or that new analysts will begin to cover us. There is also no assurance that any covering analyst will provide favorable coverage. Although we have obtained analyst coverage, if one or more of the analysts covering our business downgrade their evaluations of our stock or publish inaccurate or unfavorable research about our business, or provides more favorable relative recommendations about our competitors, the price of our stock could decline. If one or more of these analysts cease to cover our stock, we could lose visibility in the market for our stock, which in turn could cause our stock price and trading volume to decline.

We have broad discretion in the use of our cash, cash equivalents, and marketable securities and may not use them effectively.

Our management has broad discretion in the deployment and use of our cash, cash equivalents, and marketable securities and could use such funds in ways that do not improve our results of operations or enhance the value of our common stock or in ways that our stockholders may not agree with. The failure by our management to apply these funds effectively could harm our business, financial condition, results of operations, and prospects and could cause the price of our common stock to decline.

Because we do not anticipate paying any cash dividends on our common stock in the foreseeable future, capital appreciation, if any, will be the sole source of gain for our stockholders.

We have never declared or paid cash dividends on our common stock. We currently intend to retain all of our future earnings to fund the development and expansion of our business. Any determination to pay dividends in the future will be at the discretion of our board of directors. As a result, capital appreciation of our common stock, if any, will be the sole source of gain for our stockholders for the foreseeable future.

Sales of a substantial number of shares of our common stock in the public market could cause the market price of our common stock to drop significantly, even if our business is doing well.

Sales of a substantial number of shares of our common stock in the public market, or the perception in the market that the holders of a large number of shares intend to sell shares, could reduce the market price of our common stock, impair our ability to raise capital through the sale of additional equity securities, and make it more difficult for our stockholders to sell their common stock at a time and price that they deem appropriate. As of April 23, 2026, we had outstanding 65,556,531 shares of common stock and 9,164,193 shares of limited common stock. All of our outstanding shares of common stock, including shares of common stock issuable upon the conversion of shares of our limited common stock, are available for sale in the public market, subject only to the restrictions of Rule 144 under the Securities Act of 1933, as amended, in the case of our affiliates. In addition, certain of our executive officers, directors and affiliated stockholders have entered or may enter into Rule 10b5-1 plans providing for sales of shares of our common stock from time to time. Under a Rule 10b5-1 plan, a broker executes trades pursuant to parameters established by the executive officer, director or affiliated stockholder when entering into the plan, without further direction from the executive officer, director or affiliated stockholder. A Rule 10b5-1 plan may be amended or terminated in some circumstances. Our executive officers, directors and affiliated stockholders also may buy or sell additional shares outside of a Rule 10b5-1 plan when they are not in possession of material, nonpublic information.

We have also filed a universal shelf registration statement on Form S-3 which allows us to offer and sell an indeterminate number of shares of common stock, preferred stock, depositary shares or warrants, or an indeterminate

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principal amount of debt securities, from time to time pursuant to one or more offerings at prices and terms to be determined at the time of the sale. Moreover, certain holders of our common stock and our limited common stock have rights, subject to specified conditions, to include their shares in registration statements that we may file for ourselves or other stockholders and may require us to file Form S-3 registration statements covering their shares.

We are party to an amended and restated sales agreement with Leerink Partners LLC, or Leerink Partners, as sales agent, with respect to an "at the market" offering program, or the ATM, under which we could offer and sell, from time to time pursuant to our Form S-3, shares of our common stock having an aggregate offering price of up to $250.0 million, through Leerink Partners. The number of shares that are sold by Leerink Partners after we request that sales be made will fluctuate based on the market price of our common stock during the sales period and limits we set with Leerink Partners. Therefore, it is not possible to predict the number of shares that will be ultimately issued by us, if any, pursuant to the amended and restated sales agreement. As of March 31, 2026, we have sold 323,085 shares of common stock for total net proceeds of $8.7 million, and have $241.1 million of common stock remaining available for sale under the ATM.

We also have filed registration statements on Form S-8 to register shares of common stock that we may issue under our equity compensation plans. Shares registered under such registration statements are available for sale in the public market upon issuance, subject to volume limitations applicable to affiliates, vesting arrangements and exercise of options.

We have incurred and will continue to incur increased costs as a result of operating as a public company, and our management has devoted and will continue to be required to devote substantial time to new compliance initiatives and corporate governance practices.

As a public company, we have incurred and will continue to incur significant legal, accounting, and other expenses that we did not incur as a private company. The Securities Exchange Act of 1934, as amended, or the Exchange Act, Sarbanes-Oxley Act of 2002, the Dodd-Frank Wall Street Reform and Consumer Protection Act, the listing requirements of Nasdaq, and other applicable securities rules and regulations impose various requirements on public companies, including establishment and maintenance of effective disclosure and financial controls and corporate governance practices. Our management and other personnel devote and will need to continue to devote a substantial amount of time and resources to these compliance initiatives, potentially at the expense of other business concerns, which could harm our business, financial condition, results of operations, and prospects. Moreover, these rules and regulations have increased and will continue to increase our legal and financial compliance costs, and have made and will continue to make some activities more time-consuming and costly compared to when we were a private company.

We frequently evaluate our compliance with these rules and regulations, and cannot predict or estimate the amount of additional costs we may incur or the timing of such costs. These rules and regulations are often subject to varying interpretations, in many cases due to their lack of specificity, and, as a result, their application in practice may evolve over time as new guidance is provided by regulatory and governing bodies. This could result in continuing uncertainty regarding compliance matters and higher costs necessitated by ongoing revisions to disclosure and governance practices.

As a public company, we are obligated to develop and maintain proper and effective internal control over financial reporting. Any failure to maintain the adequacy of these internal controls may adversely affect investor confidence in our company and, as a result, the value of our common stock.

Pursuant to Section 404 of the Sarbanes-Oxley Act, we are required to furnish a report by our management on our internal control over financial reporting on an annual basis. This assessment needs to include disclosure of any material weaknesses identified by our management in our internal control over financial reporting. Pursuant to Section 404, we are also required to have our independent registered public accounting firm issue an opinion on the effectiveness of our internal control over financial reporting on an annual basis.

During our evaluation of our internal control, if we identify one or more material weaknesses in our internal control over financial reporting, we will be unable to assert that our internal control over financial reporting is effective. In addition, if we have an unremediated material weakness, we would receive an adverse opinion regarding our internal control over financial reporting from our independent registered public accounting firm. For example, in connection with the audit of our consolidated financial statements for the year ended December 31, 2022, we and our independent registered public accounting firm identified a material weakness in our internal control over financial reporting. While we remediated this material weakness as of December 31, 2023, we cannot assure you that there will not be material weaknesses or

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significant deficiencies in our internal control over financial reporting in the future. If in the future we again identify a material weakness, we cannot assure you that any measures we may take in the future will be sufficient to remediate such material weakness or avoid the identification of additional material weaknesses in the future. If the steps we take do not remediate a future material weakness in a timely manner, there could be a reasonable possibility that this control deficiency or others could result in a material misstatement of our annual or interim financial statements that would not be prevented or detected on a timely basis.

Any failure to maintain internal control over financial reporting could severely inhibit our ability to accurately report our financial condition, or results of operations. If we are unable to conclude in the future that our internal control over financial reporting is effective, or if we or our independent registered public accounting firm determines we have a material weakness in our internal control over financial reporting, we could lose investor confidence in the accuracy and completeness of our financial reports, we may be unable to maintain compliance with securities law requirements regarding timely filing of periodic reports in addition to applicable stock exchange listing requirements, the market price of shares of our common stock could decline, and we could be subject to sanctions or investigations by Nasdaq, the SEC, or other regulatory authorities. Failure to remedy any material weakness in our internal control over financial reporting, or to implement or maintain other effective control systems required of public companies, could also restrict our future access to the capital markets.

Our disclosure controls and procedures may not prevent or detect all errors or acts of fraud.

As a public company, we are subject to certain reporting requirements of the Exchange Act. Our disclosure controls and procedures are designed to reasonably assure that information required to be disclosed by us in reports we file or submit under the Exchange Act is accumulated and communicated to management, recorded, processed, summarized, and reported within the time periods specified in the rules and forms of the SEC. We believe that any disclosure controls and procedures or internal controls and procedures, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. These inherent limitations include the realities that judgments in decision-making can be faulty, and that breakdowns can occur because of simple error or mistake. Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two or more people or by an unauthorized override of the controls. Accordingly, because of the inherent limitations in our control system, misstatements or insufficient disclosures due to error or fraud may occur and not be detected.

Provisions in our corporate charter documents and under Delaware law could make an acquisition of our company, which may be beneficial to our stockholders, more difficult and may prevent attempts by our stockholders to replace or remove our current directors and members of management.

Provisions in our certificate of incorporation and our bylaws may discourage, delay, or prevent a merger, acquisition, or other change in control of our company that stockholders may consider favorable, including transactions in which stockholders might otherwise receive a premium for their shares. These provisions could also limit the price that investors might be willing to pay in the future for shares of our common stock, thereby depressing the market price of our common stock. In addition, because our board of directors is responsible for appointing the members of our management team, these provisions may frustrate or prevent any attempts by our stockholders to replace or remove our current management by making it more difficult for stockholders to replace members of our board of directors. Among other things, these provisions:

• establish a classified board of directors such that only one of three classes of directors is elected each year;

• allow the authorized number of our directors to be changed only by resolution of our board of directors;

• limit the manner in which stockholders can remove directors from our board of directors;

• establish advance notice requirements for stockholder proposals that can be acted on at stockholder meetings and nominations to our board of directors;

• require that stockholder actions must be effected at a duly called stockholder meeting and prohibit actions by our stockholders by written consent;

• limit who may call stockholder meetings to the board of directors or to the secretary at the request of the holders of at least 25% of the outstanding shares of our common stock and limited common stock; and

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• authorize our board of directors to issue preferred stock without stockholder approval, which could be used to institute a “poison pill” that would work to dilute the stock ownership of a potential hostile acquirer, effectively preventing acquisitions that have not been approved by our board of directors.

Moreover, because we are incorporated in Delaware, we are governed by the provisions of Section 203 of the Delaware General Corporation Law, or the DGCL, which prohibits a person who owns in excess of 15% of our outstanding voting stock from merging or combining with us for a period of three years after the date of the transaction in which the person acquired in excess of 15% of our outstanding voting stock, unless the merger or combination is approved in a prescribed manner.

Our certificate of incorporation designates the state courts in the State of Delaware as the sole and exclusive forum for certain types of actions and proceedings that may be initiated by our stockholders, which could discourage lawsuits against the company and our directors, officers, and employees.

Our certificate of incorporation provides that, unless we consent in writing to the selection of an alternative forum, the Court of Chancery of the State of Delaware (or, if the Court of Chancery of the State of Delaware does not have jurisdiction, the federal district court for the District of Delaware) will be the sole and exclusive forum for: (1) any derivative action or proceeding brought on our behalf, (2) any action asserting a claim of breach of a fiduciary duty owed by any of our directors, officers, employees or stockholders to our company or our stockholders, (3) any action asserting a claim arising pursuant to any provision of the DGCL or as to which the DGCL confers jurisdiction on the Court of Chancery of the State of Delaware or (4) any action asserting a claim arising pursuant to any provision of our certificate of incorporation or bylaws (in each case, as they may be amended from time to time) or governed by the internal affairs doctrine. These choice of forum provisions will not apply to suits brought to enforce a duty or liability created by the Securities Act of 1933, as amended, the Exchange Act or any other claim for which federal courts have exclusive jurisdiction.

This exclusive forum provision may limit the ability of our stockholders to bring a claim in a judicial forum that such stockholders find favorable for disputes with us or our directors, officers, or employees, which may discourage such lawsuits against us and our directors, officers, and employees. Alternatively, if a court were to find the choice of forum provision contained in our certificate of incorporation to be inapplicable or unenforceable in an action, we may incur additional costs associated with resolving such action in other jurisdictions, which could materially adversely affect our business, financial condition, and operating results.

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.

None.

Item 3. Defaults Upon Senior Securities.

Not applicable.

Item 4. Mine Safety Disclosures.

Not applicable.

Item 5. Other Information.

(c) Director and Officer Trading Arrangements

None of our directors or officers adopted or terminated a Rule 10b5-1 trading arrangement or a non-Rule 10b5-1 trading arrangement (as defined in Item 408(c) of Regulation S-K) during the quarterly period covered by this report.

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Item 6. Exhibits.

Exhibit

Number Description Form File No. Exhibit Filing Date Filed

Herewith

10.1 Eighth Amended and Restated Director Compensation Policy

X

10.2 Amendment No. 1 to the Master License Agreement, dated March 24 , 2026, between the Registrant and The Trustees of Columbia University in the City of New York

X

10.3 Consultant Agreement, dated July 1, 1999, between the Registrant and Richard A. Friesner, as amended

10-K

001-39206

10.24 2/25/2026

31.1 Certification of Principal Executive Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

X

31.2 Certification of Principal Financial Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

X

32.1* Certification of Principal Executive Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

X

32.2* Certification of Principal Financial Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

X

101.INS Inline XBRL Instance Document – the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document. X

101.SCH Inline XBRL Taxonomy Extension Schema Document X

101.CAL Inline XBRL Taxonomy Extension Calculation Linkbase Document X

101.DEF Inline XBRL Taxonomy Extension Definition Linkbase Document X

101.LAB Inline XBRL Taxonomy Extension Label Linkbase Document X

101.PRE Inline XBRL Taxonomy Extension Presentation Linkbase Document X

104 The cover page for the Company’s Quarterly Report on Form 10-Q has been formatted in Inline XBRL and contained in Exhibit 101 X

_____________________

* The certifications attached as Exhibits 32.1 and 32.2 that accompany this Quarterly Report, are deemed furnished and not filed with the Securities and Exchange Commission and are not to be incorporated by reference into any filing of Schrödinger, Inc. under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, whether made before or after the date of this Quarterly Report, irrespective of any general incorporation language contained in such filing.

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

Schrödinger, Inc.

Date: May 5, 2026

By: /s/ Ramy Farid, Ph.D.

President and Chief Executive Officer

(Principal Executive Officer)

Date: May 5, 2026

By: /s/ Richie Jain

Executive Vice President and Chief Financial Officer

( Principal Financial Officer)

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临床进展与现金跑道更新

重要性3/5 中

公司一手季度业绩与临床更新直接关联RXRX,包含可核对的临床、现金和财务数据;但发布时间距日报已有约两个月,且多项结论仍属早期或前瞻性信息。

中文摘要

核心结论

Recursion(递归制药,RXRX)披露2026年第一季度业绩:REC-1245早期安全性和药代数据、REC-4881二期疗效信号及REC-4539首例给药构成管线进展;公司维持2026年运营现金消耗低于3.90亿美元、现金可支持至2028年初的指引。业绩材料主要来自公司新闻稿,疗效、注册路径和未来里程碑仍有临床及监管不确定性。

重要性评级

评级:3/5(中)

这是RXRX直接发布的季度财务与临床更新,事实密度高且覆盖多个近期读数;发布时间为5月,对7月11日日报属于仍需核验后续进展的阶段性材料。

关键事实

  • 公司于05/06(未给出具体时刻)发布截至03/31的2026年第一季度结果;页面显示发布时间为美东时间 05/06 06:30(UTC+8 05/06 18:30),并安排美东时间 05/06 08:00(UTC+8 05/06 20:00)的业绩电话会。
  • REC-1245(RBM39降解剂)在实体瘤一期/二期DAHLIA研究的16名可评患者中未观察到剂量限制性毒性;62.5%出现治疗相关不良事件,绝大部分为1—2级,剂量递增仍在进行。
  • REC-4881(MEK1/2抑制剂)在家族性腺瘤性息肉病二期研究中,第13周息肉负担中位数下降43%,第25周为53%;40%患者的Spigelman分期改善。公司已与FDA(美国食品药品监督管理局)启动潜在注册研究设计沟通,预计2026年下半年更新。
  • REC-4539(LSD1抑制剂)于4月完成一期ENLYGHT研究首例患者给药,覆盖实体瘤及小细胞肺癌;公司称其可逆机制和较短预测半衰期旨在缓解同类药物常见的血小板毒性。
  • 截至03/31,现金、现金等价物及受限现金为6.652亿美元,低于2025年末的7.539亿美元;一季度经营活动现金流出8110万美元,去年同期为1.320亿美元。
  • 一季度营收647万美元,去年同期1475万美元;研发费用8790万美元、管理费用3460万美元,均低于去年同期;净亏损1.175亿美元,去年同期为2.025亿美元。
  • 公司重申2026年运营现金消耗低于3.90亿美元,并称在不额外融资的假设下,现金跑道可延续至2028年初。
  • 自研管线中,REC-1245补充剂量递增数据、REC-7735和REC-102是否启动一期的决定均预计在2026年下半年;REC-4881更多一期b/二期数据预计在2027年上半年。

作者观点与证据

新闻稿立场积极,将早期临床读数、AI(人工智能)研发平台和合作项目表述为平台转化能力的验证。财务报表、现金余额和临床样本数提供了可核对依据;REC-1245仍处于早期剂量递增,REC-4881的注册路径尚待监管沟通,平台效率、合作里程碑及未来现金跑道均含管理层前瞻性假设。

与相关标的的关系

RXRX的直接关联来自自研肿瘤及罕见病管线、与FDA的沟通进度和流动性。REC-4881的监管设计更新、REC-1245的后续剂量数据,以及现金消耗是否符合指引,均会改变对研发推进速度和融资需求的事实判断。

时效性与限制

文章发布于05/06,页面给出美东时间 05/06 06:30(UTC+8 05/06 18:30);相对07/11已有约两个月滞后,适合作为季度基线,需结合其后临床、监管及现金信息更新。来源为公司投资者关系新闻稿,存在宣传性;REC-1245样本仅16人,REC-4881的详细研究设计、对照信息和长期随访未在文中完整呈现。

后续跟踪

  • REC-4881在2026年下半年披露的FDA沟通及注册研究设计信息。
  • REC-1245剂量递增后的安全性、推荐二期剂量和初步疗效数据。
  • REC-7735与REC-102的临床启动决定及其支持数据。
  • 季度现金消耗、合作收入和现金跑道指引是否与后续财报一致。
原文
Recursion Reports First Quarter 2026 Financial Results and Provides Business Updates

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Recursion Reports First Quarter Financial Results and Provides Business Update

May 6, 2026 at 6:30 AM EDT

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  • Multiple milestones achieved or on track across wholly owned and partnered programs
  • REC-1245 (RBM39 degrader): Early clinical data in solid tumors demonstrate a well-tolerated safety profile and predictable, dose-dependent pharmacokinetics; no DLTs observed to date, supporting ongoing dose escalation
  • REC-4881 (FAP / MEK1/2): Strong Phase 2 efficacy signals with FDA engagement initiated to define potential registrational pathway; update expected in 2H26
  • REC-4539 (LSD1 inhibitor): First patient dosed in Phase 1; platform-derived, selective, brain-penetrant profile, designed to have a reversible mechanism to reduce on-target platelet toxicity, supporting differentiation in solid tumors and AML
  • Disciplined capital execution: Reiterate 2026 guidance of < $390 million operational cash burn, supporting runway into early 2028 without additional financing

SALT LAKE CITY , May 06, 2026 (GLOBE NEWSWIRE) -- Recursion (Nasdaq: RXRX) a leading clinical stage TechBio company decoding biology to radically improve lives, today reported business updates highlighting strong continued pipeline execution, clinical progress and platform advancement, as well as financial results for its first quarter ended March 31, 2026 .

Recursion will host an Earnings Call on May 6, 2026 at 8:00 am ET / 6:00 am MT / 1:00 pm BST from Recursion’s X , LinkedIn , and YouTube accounts giving analysts, investors, and the public the opportunity to ask questions of the Company by submitting questions here: https://forms.gle/TQ4vgUTLKsFmikcu6 .

“We are seeing strong momentum and execution across our portfolio, with increasing evidence that our full stack platform can translate biological and chemical insights into differentiated clinical programs,” said Najat Khan , Ph.D., Chief Executive Officer and President of Recursion. “Recent progress, including encouraging initial safety and PK data in REC-1245 and the first patient dosed in REC-4539, represents a growing set of proof points that demonstrate our ability to translate platform insights into clinical programs. This momentum reflects the strength of our end-to-end AI platform, with multiple differentiated internal and partnered programs advancing into and through the clinic.”

Business Highlights

Wholly Owned Pipeline Updates

Translating insight into proof

Favorable Safety and PK Data for REC-1245 (RBM39):

Preliminary safety and pharmacokinetic (PK) data from REC-1245, a potential first-in-class RBM39 degrader discovered and developed using Recursion’s platform, highlight early clinical progress for a novel approach to targeting cancer vulnerabilities linked to replication stress and DNA repair.

REC-1245 advanced from biological discovery to development candidate in 18 months, more than twice as fast as the industry average, demonstrating Recursion’s ability to identify novel targets and design differentiated molecules using its integrated AI-enabled platform.

Early data from the ongoing Phase 1/2 DAHLIA study show:

  • REC-1245 was well-tolerated across select solid tumors (n=16)
  • No dose-limiting toxicities (DLTs) have been observed to date, and the maximum tolerated dose has not yet been reached
  • The majority of TRAEs were Grade 1 or 2, most common GI-related events were constipation, nausea, and vomiting
  • Pharmacokinetic analysis demonstrates predictable, dose-dependent exposure across evaluated patients
  • Pharmacodynamic assessments demonstrate target engagement
  • Dose escalation is ongoing to determine the recommended Phase 2 dose for monotherapy expansion cohorts

Treatment-Related Adverse Event (TRAE)

Patients (n=16)

Patients with any TRAE 10 (62.5%)

Grade 1-2 9 (56.3%)

Grade 3 1 (6.2%)

Grade 4-5 0 (0.0%)

Continued Momentum for REC-4881 (MEK1/2):

REC-4881 is an allosteric MEK1/2 inhibitor being developed for familial adenomatous polyposis (FAP), a genetically defined disease driven by APC loss. Based on platform insights into MAPK pathway modulation in APC-deficient systems, REC-4881 represents a targeted approach to addressing the underlying biology of disease progression:

  • Phase 2 positive proof-of-concept clinical data showed a median 43% reduction in polyp burden at Week 13, deepening to 53% at Week 25 following a treatment break, with 40% of patients demonstrating improvement in Spigelman stage, supporting a differentiated and durable profile in FAP.
  • Safety was consistent with MEK1/2 inhibition, with mostly Grade 1-2 TRAEs, Grade 3 events in 15.8% of patients, no Grade ≥4 TRAEs, and commonly including dermatitis acneiform/rash and increased CPK.

Recursion has initiated FDA engagement to align on a potential registrational study design, with an update expected in the second half of 2026. Expansion of TUPELO to include patients aged 18+ to support a broader development strategy is also ongoing.

First Patient Dosed in REC-4539 (LSD1 inhibitor):

REC-4539, an AI-designed, LSD1 inhibitor, highlights early progress for a differentiated approach to targeting epigenetic drivers in cancer. In April, the first patient was dosed in the ENLYGHT Phase 1 clinical study for solid tumors, including small cell lung cancer (SCLC).

REC-4539 was precision designed to have a reversible mechanism and shorter predicted human half-life to address treatment-limiting platelet toxicity observed with other LSD1 inhibitors, enabling a potentially differentiated profile across solid tumors and hematologic malignancies.

The differentiated, CNS-penetrant development candidate was delivered in approximately 20 months through Recursion’s AI-native design platform, demonstrating the Company’s ability to rapidly translate platform insights into optimized clinical candidates.

For the rest of the portfolio, programs continue to progress as planned.

Expected upcoming milestones across Recursion’s wholly-owned pipeline:

  • REC-4881 (MEK1/2):
  • Regulatory update expected in 2H26
  • Additional Phase 1b/2 clinical data expected in 1H27
  • REC-1245 (RBM39): Additional Phase 1 dose escalation data expected in 2H26
  • REC-7735 (PI3Kα H1047R) and REC-102 (ENPP1): IND-enabling studies ongoing; data-driven go/no-go decision on Phase 1 initiation expected in 2H26
  • REC-617 (CDK7): Early Phase 1 safety and PK combination data expected in 1H27
  • REC-3565 (MALT1): Early Phase 1 safety and PK monotherapy data expected in 1H27
  • REC-4539 (LSD1): Early Phase 1 safety and PK monotherapy data expected in 2H27

Advancing partnered discovery, with over $500 million in milestone and upfront payments achieved to date:

Advancing partnered discovery with meaningful upcoming milestones

Meaningful upcoming milestones across partnered discovery:

Recursion continues to advance partnered programs that leverage complementary strengths of the Recursion OS.

In AI-enabled chemistry, Sanofi and Recursion joint programs continue progressing toward development candidate designation and earlier-stage milestones over the next 12 months, including programs designed against challenging targets in immunology and oncology.

In AI-enabled biology, Recursion expects to continue jointly translating insights from its large-scale maps of biology delivered to Roche and Genentech into potential target validation milestones over the next 12 months. The maps, jointly built by Recursion, Roche and Genentech are disease-relevant high-content maps built at large scale, including a Neuron map generated from a subset of 1 trillion internally manufactured iPSC-derived neuronal cells and a Microglia map generated from more than 100 billion internally manufactured iPSC-derived microglial cells. Additionally, we are combining our phenomics dataset with Roche and Genentech’s proprietary transcriptomics data to build multi-modal maps designed to explore potential novel targets and pathways by systematically linking gene perturbations to cellular phenotypes.

Recursion OS Advances: Driving platform innovations, grounded in impact

Full Stack AI-powered Platform: The Recursion Operating System (OS) is continuing to drive program development by integrating AI across multimodal biology, precision design, and next-generation clinical development—enabling faster, more efficient, and more innovative drug discovery and development from biology to insight, insight to molecule, and molecule to patient.

State of the Art Transcriptomics Models: Built to better connect Recursion’s proprietary perturbational biology with patient biology to find novel insights and medicines, the integration of these models help bridge the translation gap between what we see in the lab and what matters in disease:

  • TxPert, recently featured in Nature Biotechnology , is a proof-of-principle model for predicting transcriptomic responses to perturbations. The model can generalize beyond its training data, including predicting responses to unseen single-gene perturbations, novel combinations, and known perturbations in new cell types—enabling more efficient hypothesis generation and experimental prioritization, and laying the foundation for Recursion's Virtual Cell.
  • TxFM , presented at the ICLR Workshop on Foundation Models for Science, is a transcriptomics foundation model designed to connect lab perturbations with patient biology within the Recursion OS. Trained on a large, curated dataset of public and proprietary data, it outperforms 16 leading foundation models and baselines, including models trained on datasets 10–100x larger. Beyond enabling target identification, mechanistic understanding, and patient stratification, TxFM's superior batch correction and denoising drive operational efficiency—reducing experimental re-runs, enabling cross-experiment comparisons, and increasing the value of every sequencing dollar spent.

First Quarter 2026 Financial Results

  • Cash Position: Cash, cash equivalents and restricted cash were $665.2 million as of March 31, 2026 compared to $753.9 million as of December 31, 2025 . Based on current operating plans and with no additional financing, the Company continues to expect its cash runway to extend into early 2028 .
  • Revenue: Total revenue, consisting primarily of revenue from collaboration agreements, was $6.5 million for the first quarter of 2026, compared to $14.7 million for the first quarter of 2025. Roche revenue recognized was less in the current period due to the successful completion of certain project phases in the prior period.
  • Research and Development Expenses: Research and development expenses decreased to $87.9 million for the first quarter of 2026, from $129.6 million for the first quarter of 2025. The decrease was primarily due to lower platform costs resulting from the timing of Tempus record purchases as well as lower costs due to improved operating efficiency. Specifically, the first quarter of 2025 included $27.1 million in non-cash expenses for the use of patient-centric multimodal oncology data within the Company’s R&D pipeline.
  • General and Administrative Expenses: General and administrative expenses were $34.6 million for the first quarter of 2026 compared to $54.7 million for the first quarter of 2025. The decrease of $20.1 million relative to the three months ended March 31, 2025 , was primarily driven by a decrease in salaries and one-time transaction costs incurred in the prior year.
  • Net Loss: Net loss was $117.5 million for the first quarter of 2026, compared to a net loss of $202.5 million for the first quarter of 2025.
  • Operational Cash Flows: Net cash used in operating activities was $81.1 million for the three months ended March 31, 2026 , compared to net cash used in operating activities of $132.0 million for the three months ended March 31, 2025 . The decrease in cash used in operating activities was primarily driven by operating efficiencies across the company and the strategic reprioritization of our clinical portfolio.
  • Cash Operating Expense : Cash operating expense, excluding partnership inflows and transaction costs, for the three months ended March 31, 2026 was $85.1 million compared to $120.2 million for the three months ended March 31, 2025 .

About Recursion

Recursion (NASDAQ: RXRX) is a clinical stage TechBio company decoding biology to radically improve lives. Recursion is advancing a portfolio of differentiated investigational medicines across its wholly owned and partnered pipeline in oncology, rare disease, neuroscience, immunology, and other therapeutic areas with significant unmet need. Enabling its mission is the Recursion OS, an AI-native, end-to-end drug discovery and development platform integrating biology, chemistry, and clinical development into a unified intelligence system. Powered by proprietary multimodal data, purpose-built AI models, and bilingual teams fluent in both science and AI, the Recursion OS is designed to translate complex science into medicines that matter — faster, better, and at scale — for patients who are waiting.

Recursion’s platform infrastructure is anchored in Salt Lake City, Utah and Milton Park , Oxfordshire , where its automated biology and chemistry laboratories generate proprietary data at industrial scale. Recursion also maintains offices in New York , Montréal , and London , three global hubs for talent and leadership at the intersection of AI and scientific innovation. Learn more at www.recursion.com , or connect on X and LinkedIn .

Media Contact

media@recursion.com

Investor Contact

investor@recursion.com

Recursion Pharmaceuticals Inc

Consolidated Statements of Operations (unaudited)

(in thousands, except share and per share amounts)

Three months ended March 31 ,

2026

2025

Revenue

Operating revenue $ 6,301 $ 14,818

Grant revenue 171 (73 )

Total revenue 6,472 14,745

Operating costs and expenses

Cost of revenue 12,490 21,829

Research and development 87,896 129,634

General and administrative 34,591 54,650

Total operating costs and expenses 134,977 206,113

Loss from operations (128,505 ) (191,368 )

Other income (loss), net 6,397 (11,277 )

Loss before income tax benefit (122,108 ) (202,645 )

Income tax benefit 4,604 158

Net loss $ (117,504 ) $ (202,487 )

Per share data

Net loss per share of Class A, B and Exchangeable common stock, basic and diluted $ (0.22 ) $ (0.50 )

Weighted-average shares (Class A, B and Exchangeable) outstanding, basic and diluted 529,303,984 402,771,972

Recursion Pharmaceuticals Inc

Consolidated Balance Sheets (unaudited)

(in thousands)

March 31 ,

December 31 ,

2026

2025

Assets

Current assets

Cash and cash equivalents $ 654,473 $ 743,294

Restricted cash 5,511 4,594

Other receivables 13,585 24,649

Prepaid data assets 11,742 11,742

Other current assets 24,246 28,566

Total current assets 709,557 812,845

Restricted cash, non-current 5,196 6,033

Property and equipment, net 95,811 103,931

Operating lease right-of-use assets 42,816 45,339

Financing lease right-of-use assets 18,694 20,210

Intangible assets, net 294,073 309,903

Goodwill 160,170 162,158

Deferred tax assets 957 957

Other assets, non-current 12,248 12,754

Total assets $ 1,339,522 $ 1,474,130

Liabilities and stockholders’ equity

Current liabilities

Accounts payable $ 20,348 $ 18,118

Accrued expenses and other liabilities 54,205 70,230

Unearned revenue 32,794 37,605

Operating lease liabilities 13,087 12,663

Notes payable and financing lease liabilities 9,265 9,091

Total current liabilities 129,699 147,707

Unearned revenue, non-current 114,723 114,012

Operating lease liabilities, non-current 42,842 46,647

Notes payable and financing lease liabilities, non-current 7,181 9,564

Deferred tax liabilities 18,283 23,255

Other liabilities, non-current 2,025 2,080

Total liabilities 314,753 343,265

Stockholders’ equity

Common stock (Class A, B and Exchangeable) 5 5

Additional paid-in capital 3,191,608 3,170,145

Accumulated deficit (2,193,506 ) (2,076,002 )

Accumulated other comprehensive income (loss) 26,662 36,717

Total stockholders’ equity 1,024,769 1,130,865

Total liabilities and stockholders’ equity $ 1,339,522 $ 1,474,130

Recursion Pharmaceuticals Inc

Selected Cash Flow Information (unaudited)

(in thousands)

Three months ended March 31 ,

2026

2025

Net cash used in operating activities $ (81,101 ) $ (131,957 )

Net cash used in investing activities (338 ) (7,270 )

Net cash provided by (used in) financing activities (3,470 ) 40,527

Effect of exchange rate changes on cash, cash equivalents and restricted cash (3,832 ) 4,833

Cash, cash equivalents and restricted cash, beginning of period 753,921 603,024

Cash, cash equivalents and restricted cash, end of period $ 665,180 $ 509,157

Non-GAAP Financial Measure

The reconciliation of operating cash expense to net cash used in operating activities is provided in the following tables:

Cash Operating Expense - Q1 2026 (in millions)

Net cash used in operating activities $ 81.1 *

Add: partnership inflows 4.0

Cash Operating Expense - Q1 2026 $ 85.1

*This is from the Recursion Inc Consolidated Statement of Cash Flows for the three months ended March 31, 2026 (see above)

Cash Operating Expense - Q1 2025 (in millions)

Net cash used in operating activities $ 132.0 *

Subtract: transaction costs (11.8 )

Cash Operating Expense - Q1 2025 $ 120.2

*This is from the Recursion Inc Consolidated Statement of Cash Flows for the three months ended March 31, 2025 (see above)

To supplement our financial statements prepared in accordance with U.S. GAAP, we monitor and consider operating cash expense, which is a non-GAAP financial measure. We define operating cash expense as the net cash used in operating activities, excluding non-ordinary course transaction costs and partnership cash inflows. This non-GAAP financial measure is not based on any standardized methodology prescribed by U.S. GAAP and is not necessarily comparable to similarly-titled measures presented by other companies. We believe operating cash expense to be a liquidity measure that provides useful information to management and investors about the amount of cash consumed by the operations of the business. A limitation of using this non- U.S. GAAP measure is that operating cash expense does not represent the total change in cash and cash equivalents for the period because it excludes cash provided by or used for other investing and financing activities. We account for this limitation by providing information about our capital expenditures and other investing and financing activities in the statements of cash flows in our financial statements. Additionally, we reconciled operating cash expense above to net cash used in operating activities, the most directly comparable U.S. GAAP financial measure. In addition, it is important to note that other companies, including companies in our industry, may not use operating cash expense, may calculate operating cash expense in a different manner than we do or may use other financial measures to evaluate their performance, all of which could reduce the usefulness of operating cash expense as a comparative measure. Because of these limitations, operating cash expense should not be considered in isolation from, or as a substitute for, financial information prepared in accordance with U.S. GAAP.

Forward-Looking Statements

This document contains information that includes or is based upon “forward-looking statements” within the meaning of the Securities Litigation Reform Act of 1995, including, without limitation, those regarding the occurrence or realization of potential milestones; the timing of data readouts and other milestones; the impact of initial safety and PK data from the REC-1245 trial on the future success of the trial; the timing and outcome of anticipated engagement with the FDA; financial position, cash runway, and cash burn; Recursion’s ability to translate platform insights into tangible proof; the impact of preclinical data on trial outcomes; Recursion's future as a leader in TechBio and ability to deliver better treatments to patients faster; expectations relating to early and late stage discovery, preclinical, and clinical programs, including timelines for commencement of and enrollment in studies, data readouts, meetings with regulators, and progression toward IND-enabling studies; expectations and developments with respect to licenses and collaborations, including option exercises by partners and the amount and timing of potential milestone payments, and the acceleration of progress across multiple partnered programs; prospective products and their potential future indications and market opportunities; developments with Recursion OS, including achieving future returns on investment in the platform and the ability to discover and develop new medicines and provide insights into patient populations; and all other statements that are not historical facts. Forward-looking statements may or may not include identifying words such as “plan,” “will,” “expect,” “anticipate,” “intend,” “believe,” “potential,” “continue,” and similar terms. These statements are subject to known or unknown risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements, including but not limited to: challenges inherent in pharmaceutical research and development, including the timing and results of preclinical and clinical programs, where the risk of failure is high and failure can occur at any stage prior to or after regulatory approval due to lack of sufficient efficacy, safety considerations, or other factors; our ability to leverage and enhance our drug discovery platform; our ability to obtain financing for development activities and other corporate purposes; the success of our collaboration activities; our ability to obtain regulatory approval of, and ultimately commercialize, drug candidates; our ability to obtain, maintain, and enforce intellectual property protections; cyberattacks or other disruptions to our technology systems; our ability to attract, motivate, and retain key employees and manage our growth; inflation and other macroeconomic issues; and other risks and uncertainties such as those described under the heading “Risk Factors” in our filings with the U.S. Securities and Exchange Commission, including our Annual Report on Form 10- K. All forward-looking statements are based on management’s current estimates, projections, and assumptions, and Recursion undertakes no obligation to correct or update any such statements, whether as a result of new information, future developments, or otherwise, except to the extent required by applicable law.

Photos accompanying this announcement are available at:

https://www.globenewswire.com/NewsRoom/AttachmentNg/d2751ce2-f602-4ebf-b6b6-8acff83456f5

https://www.globenewswire.com/NewsRoom/AttachmentNg/4ce21071-12a0-4234-b8c1-b5c0fd1d0e99

Recursion’s wholly owned pipeline:

Translating insight into proof

Partners

Advancing partnered discovery with meaningful upcoming milestones

Source: Recursion Pharmaceuticals

打开原文

莫德纳一季度收入回升与和解成本

重要性4/5 高

SEC 一手季报直接覆盖 MRNA 的收入构成、亏损、流动性、产品审批和专利和解,事实密度高且与标的直接相关;但财务截止日为 03/31,时效性已有滞后。

中文摘要

核心结论

Moderna(莫德纳,代码 MRNA)2026 年第一季度产品销售升至 3.52 亿美元、同比增逾三倍,但 9.50 亿美元 Arbutus/Genevant 专利和解相关成本推高成本费用,净亏损扩大至 13.43 亿美元。公司在呼吸道疫苗销售回升、组合疫苗获欧盟批准和研发管线推进之间,仍面临现金消耗、销售季节性及后续专利诉讼的不确定性。

重要性评级

评级:4/5(高)

这是 MRNA 的美国证券交易委员会 SEC(美国证券交易委员会)一手季度申报文件,直接披露收入、亏损、现金流、产品进展和诉讼敞口。文件发布于 05/07(未给出具体时刻),对 07/11 日报属于较新的基本面材料,但已不能替代后续季度更新或实时经营信息。

关键事实

  • 截至 03/31 的三个月,总收入为 3.89 亿美元,上年同期为 1.08 亿美元;净产品销售为 3.52 亿美元,上年同期为 0.86 亿美元。
  • 新冠疫苗 Spikevax 与 mNEXSPIKE 销售为 3.45 亿美元;呼吸道合胞病毒 RSV(呼吸道合胞病毒)疫苗 mRESVIA 销售为 0.07 亿美元。欧洲销售为 2.39 亿美元,美国为 0.73 亿美元,销售地域集中度较高。
  • 当季净亏损 13.43 亿美元、每股亏损 3.40 美元;上年同期净亏损为 9.71 亿美元。销售成本为 9.55 亿美元,其中包含与 Arbutus 和 Genevant 和解相关的约 8.78 亿美元特许权使用费费用。
  • 03/03,Moderna 与 Arbutus/Genevant 达成全球专利诉讼和解,约定于 2026 年第三季度支付 9.50 亿美元一次性款项;针对美国法典第 1498 条判决的上诉结果,可能另有最高 13 亿美元付款,公司截至 03/31 未对此确认负债。
  • 经营活动现金流出 6.30 亿美元,低于上年同期的 10.37 亿美元;期末现金及现金等价物为 19.08 亿美元,流动及非流动投资合计为 55.48 亿美元。
  • 04 月,mCOMBRIAX(流感与新冠组合疫苗)获欧盟委员会批准用于 50 岁及以上人群;该批准仍须经历各国准入和商业化环节。
  • 公司披露 mRNA-3927(丙酸血症候选疗法)与 Recordati 的合作已于 03/16 完成,Recordati 支付 5,000 万美元预付款;该候选药注册性研究已达目标入组,潜在数据预计在 2026 年公布。

作者观点与证据

文件是公司向 SEC 提交的 10-Q(季度报告),财务报表、产品销售拆分、资产负债表和现金流属于可核验的一手披露。管理层称预计 2026 年销售恢复增长,并预期继续提升成本效率;这些表述属于前瞻性预期,依赖呼吸道疫苗市场、监管准入、临床进展和商业执行,尚非已实现结果。

与相关标的的关系

MRNA 的收入端目前主要由新冠疫苗支撑:当季 3.52 亿美元产品销售中 3.45 亿美元来自新冠产品。和解费用显著影响本季亏损和销售成本,9.50 亿美元第三季度现金付款及最高 13 亿美元潜在追加付款是资金与法律风险的直接变量。组合疫苗欧盟获批、罕见病候选药合作和临床数据则关系到收入来源扩展的验证进度。

时效性与限制

报告发布于 05/07(未给出具体时刻),财务观察截止于 03/31,距 07/11 已超过两个月。该文件未经审计的季度财务报表可用于基本面核对,但没有提供第二季度销售、实际付款、后续诉讼进展或欧盟各国商业准入结果;疫苗销售还存在秋冬旺季特征,单季数据不代表全年表现。

后续跟踪

  • 2026 年第三季度 9.50 亿美元和解款的支付与现金余额变化。
  • 第 1498 条上诉结果及最高 13 亿美元潜在额外付款的进展。
  • mCOMBRIAX 在欧盟成员国的准入、定价和实际销售数据。
  • 新冠、RSV 疫苗的秋冬季订单、地域销售构成与 mRNA-3927 临床数据。
原文
Moderna Quarterly Report for the Quarter Ended March 31, 2026

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 20549

FORM 10-Q

(Mark One)

☒      QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended March 31, 2026

OR

☐     TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from _ to _

Commission File Number: 001-38753

Moderna, Inc.

(Exact Name of Registrant as Specified in Its Charter)

Delaware 81-3467528

(State or Other Jurisdiction of Incorporation or Organization) (IRS Employer Identification No.)

325 Binney Street

Cambridge, Massachusetts 02142

(Address of Principal Executive Offices) (Zip Code)

( 617 ) 714-6500

(Registrant’s Telephone Number, Including Area Code)

Securities registered pursuant to Section 12(b) of the Act:

Title of each class Trading symbol(s) Name of each exchange on which registered

Common stock, par value $0.0001 per share MRNA The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒      No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer”, “accelerated filer”, “smaller reporting company”, and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer ☒ Accelerated filer o

Non-accelerated filer o

Smaller reporting company ☐

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes ☐ No ☒

As of April 24, 2026, there were 396,786,259 shares of the registrant’s common stock, par value $0.0001 per share, outstanding.

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q (Form 10-Q) contains express or implied forward-looking statements. All statements other than those of historical facts contained in this Form 10-Q are based on our management’s beliefs and assumptions and on information currently available to our management. Forward-looking statements in this Form 10-Q include, but are not limited to, statements about:

• our ability to drive use of our commercial products and expectations regarding a return to sales growth in 2026;

• our ability to execute on our prioritized research and development portfolio;

• our ability to deliver cost efficiency across our business;

• our expectations regarding the size and durability of the respiratory vaccine market;

• the availability of mCOMBRIAX across the EU, subject to national regulatory and access procedures;

• our long-term strategic partnerships with government entities;

• anticipated near-term regulatory actions for our product candidates, including potential filings, reviews and approvals;

• anticipated milestones for our pipeline programs, including potential data readouts and other near-term catalysts;

• our ability to obtain and maintain regulatory approval of our product candidates across our portfolio;

• our ability to successfully launch and commercialize our products and the timing of launches;

• the potential of our oncology portfolio;

• our ability and the ability of third parties with whom we contract to successfully manufacture, supply and distribute our commercial products and any future commercial products at scale, as well as drug substances, delivery vehicles, development candidates, and investigational medicines for preclinical and clinical use;

• financing and funding options we may consider as part of our research and development strategy;

• our ability to successfully contract with third-party suppliers, distributors and manufacturers;

• internal and external costs associated with manufacturing our products and the impact on our cost of sales, and our anticipated cost of sales as a percentage of net product sales;

• the scope of protection we are able to establish and maintain for intellectual property rights, including those covering our commercial products, product candidates and technology, and our expectations regarding pending legal proceedings related to our intellectual property;

• the timing of initiation, progress, completion, results and cost of our clinical trials, preclinical studies and research and development programs, as well as those of our collaborators;

• participant enrollment in our clinical trials, including timing;

• potential advantages of mRNA as compared to traditional medicine;

• the implementation of our business model and strategic plans for our business, products, product candidates and technology;

• the pricing and reimbursement of our products, if approved;

• the build out of our manufacturing and commercial operations;

• estimates of our future expenses, revenues and capital requirements;

• our operation and funding requirements, including our forecast of the period of time through which our financial resources will be adequate to support our operations;

• the potential benefits of strategic collaboration agreements and our ability to enter into strategic collaborations or other agreements with collaborators with development, regulatory and commercialization expertise;

• our financial performance;

• our tax positions and related tax liabilities;

• legal and regulatory developments in the United States and foreign countries;

• our ability to produce our products or product candidates with advantages in turnaround times or manufacturing cost; and

• developments relating to our competitors and our industry.

Forward-looking statements often contain words such as “will,” “may,” “should,” “could,” “expects,” “intends,” “plans,” “aims,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. Although we believe that the expectations reflected in these forward-looking statements are reasonable, these statements relate to future events or our operational or financial performance, and involve risks, uncertainties, and other factors that may cause our actual results to differ materially from any future results expressed or implied by these forward-looking statements. Accordingly, you should not place undue reliance on these forward-looking statements. Factors that may cause actual results to differ materially from current expectations include, among other things, those listed under the section entitled “Risk Factors” and elsewhere in this Form 10-Q and under Part I, Item 1A. “Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended December 31, 2025. If one or more of these risks or uncertainties occur, or if our underlying assumptions prove to be incorrect, actual results could differ materially from those expressed or implied by the forward-looking statements.

The forward-looking statements in this Form 10-Q represent our views as of the date of this Form 10-Q. We undertake no obligation to update any forward-looking statements, except as required by applicable securities law. You should therefore not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this Form 10-Q. However, any further disclosures made on related subjects in our subsequent reports filed with the Securities and Exchange Commission should be consulted.

TRADEMARKS

This Form 10-Q contains references to our trademarks and to trademarks belonging to other entities. Solely for convenience, trademarks and trade names referred to may appear without the ® or ™ symbols, but such references are not intended to indicate that their respective owners will not assert, to the fullest extent under applicable law, their rights thereto. We do not intend our reference to other companies’ trade names or trademarks to imply a relationship with, or endorsement or sponsorship of us by, any other companies.

NOTE REGARDING COMPANY REFERENCES

Unless the context otherwise requires, the terms “Moderna,” the “Company,” “we,” “us” and “our” in this Form 10-Q refer to Moderna, Inc. and its consolidated subsidiaries.

ADDITIONAL INFORMATION

Our website, www.modernatx.com, including the Investor Relations section, www.investors.modernatx.com; and corporate blog www.modernatx.com/moderna-blog, and our Statements and Perspectives webpage, https://investors.modernatx.com/Statements--Perspectives/default.aspx; as well as our social media channels: Facebook, www.facebook.com/modernatx; X, www.x.com/moderna_tx (@moderna_tx); LinkedIn, www.linkedin.com/company/modernatx; Instagram (@moderna_tx); and Threads (@moderna_tx) contain a significant amount of information about us, including financial and other information for investors. We encourage investors to visit these websites and social media channels as information is frequently updated and new information is shared. Information contained on our website, corporate blog and social media channels shall not be deemed incorporated into, or be a part of, this Form 10-Q.

Table of Contents

PART I.

Page

Item 1. Financial Statements (Unaudited)

5

Condensed Consolidated Balance Sheets as of March 31 , 202 6 and December 31, 2025

5

Condensed Consolidated Statements of Operations for the three months ended March 31 , 202 6 and 2025

6

Condensed Consolidated Statements of Comprehensive Income (Loss) for the three months ended Ma rch 31, 202 6 and 2025

7

Condensed Consolidated Statements of Stockholders' Equity for the three months ended March 31 , 202 6 and 2025

8

Condensed Consolidated Statements of Cash Flows for the three months ended Marc h 31 , 202 6 and 2025

9

Notes to Condensed Consolidated Financial Statements

10

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

28

Item 3. Quantitative and Qualitative Disclosures about Market Risk

37

Item 4. Controls and Procedures

37

PART II.

Item 1.

Legal Proceedings

38

Item 1A.

Risk Factors

38

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

39

Item 5.

Other Information

39

Item 6. Exhibits

39

SIGNATURES

40

Table of Contents

Item 1. Financial Statements

MODERNA, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(Unaudited, in millions, except per share data)

March 31, December 31,

2026 2025

Assets

Current assets:

Cash and cash equivalents $ 1,908   $ 2,595

Investments 3,297   3,204

Accounts receivable, net 71   184

Inventory 146   153

Prepaid expenses and other current assets 348   408

Total current assets 5,770   6,544

Investments, non-current 2,251   2,336

Property, plant and equipment, net 2,086   2,134

Right-of-use assets, operating leases 706   719

Other non-current assets 675   605

Total assets $ 11,488   $ 12,338

Liabilities and Stockholders’ Equity

Current liabilities:

Accounts payable $ 161   $ 317

Accrued liabilities 1,912   1,386

Deferred revenue 102   99

Other current liabilities 220   185

Total current liabilities 2,395   1,987

Deferred revenue, non-current 154   153

Operating lease liabilities, non-current 645   653

Financing lease liabilities, non-current 13   20

Long-term debt 590   590

Other non-current liabilities 283   285

Total liabilities 4,080   3,688

Commitments and contingencies ( Note 1 2 )

Stockholders’ equity:

Preferred stock, par value $ 0.0001 ; 162  shares authorized as of March 31, 2026 and December 31, 2025; no shares issued or outstanding at March 31, 2026 and December 31, 2025

—   —

Common stock, par value $ 0.0001 ; 1,600 shares authorized as of March 31, 2026 and December 31, 2025; 397 and 394 shares issued and outstanding as of March 31, 2026 and December 31, 2025, respectively

—   —

Additional paid-in capital 1,503   1,382

Accumulated other comprehensive income 25   45

Retained earnings 5,880   7,223

Total stockholders’ equity 7,408   8,650

Total liabilities and stockholders’ equity $ 11,488   $ 12,338

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

5

Table of Contents

MODERNA, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited, in millions, except per share data)

Three Months Ended March 31,

2026 2025

Revenue:

Net product sales $ 352   $ 86

Other revenue 37   22

Total revenue 389   108

Operating expenses:

Cost of sales 955   90

Research and development 649   856

Selling, general and administrative 173   212

Total operating expenses 1,777   1,158

Loss from operations ( 1,388 ) ( 1,050 )

Interest income 72   90

Other expense, net ( 18 ) ( 4 )

Loss before income taxes ( 1,334 ) ( 964 )

Provision for income taxes 9   7

Net loss $ ( 1,343 ) $ ( 971 )

Net loss per share

Basic and diluted

$ ( 3.40 ) $ ( 2.52 )

Weighted average common shares used in calculation of net loss per share

Basic and diluted

395   386

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

6

Table of Contents

MODERNA, INC.

CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS)

(Unaudited, in millions)

Three Months Ended March 31,

2026 2025

Net loss $ ( 1,343 ) $ ( 971 )

Other comprehensive income, net of tax:

Available-for-sale securities:

Unrealized (losses) gains on available-for-sale securities ( 17 ) 16

Less: net realized gains on available-for-sale securities reclassified in net loss —   ( 1 )

Net (decrease) increase from available-for-sale securities ( 17 ) 15

Pension and postretirement obligation adjustments —   2

(Losses) gains on foreign currency translation ( 3 ) 3

Total other comprehensive (loss) income ( 20 ) 20

Comprehensive loss $ ( 1,363 ) $ ( 951 )

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

7

Table of Contents

MODERNA, INC.

CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY

(Unaudited, in millions)

Common Stock Additional

Paid-In

Capital Accumulated

Other

Comprehensive Income Retained Earnings Total

Stockholders’

Equity

Shares Amount

Balance at December 31, 2025 394   $ —   $ 1,382   $ 45   $ 7,223   $ 8,650

Vesting of restricted common stock units 2   —  —  —  —  —

Exercise of options to purchase common stock 1   —  19   —  —  19

Tax payments related to net share settlements on equity awards —  —  ( 2 ) —  —  ( 2 )

Stock-based compensation —  —  104   —  —  104

Other comprehensive loss, net of tax —  —  —  ( 20 ) —  ( 20 )

Net loss —  —  —  —  ( 1,343 ) ( 1,343 )

Balance at March 31, 2026 397   $ —   $ 1,503   $ 25   $ 5,880   $ 7,408

Common Stock Additional

Paid-In

Capital Accumulated

Other

Comprehensive

(Loss) Income Retained Earnings Total

Stockholders’

Equity

Shares Amount

Balance at December 31, 2024 386   $ —   $ 866   $ ( 10 ) $ 10,045   $ 10,901

Vesting of restricted common stock 1   —  —  —  —  —

Exercise of options to purchase common stock —  —  2   —  —  2

Tax payments related to net share settlements on equity awards —  —  ( 1 ) —  —  ( 1 )

Stock-based compensation —  —  115   —  —  115

Other comprehensive income, net of tax —  —  —  20   —  20

Net loss —  —  —  —  ( 971 ) ( 971 )

Balance at March 31, 2025 387   $ —   $ 982   $ 10   $ 9,074   $ 10,066

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

8

Table of Contents

MODERNA, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited, in millions)

Three Months Ended March 31,

2026 2025

Operating activities

Net loss $ ( 1,343 ) $ ( 971 )

Adjustments to reconcile net loss to net cash used in operating activities:

Stock-based compensation 104   115

Depreciation and amortization 59   39

Amortization/accretion of investments ( 11 ) ( 19 )

Loss on equity investments, net 2   8

Other non-cash items 6   2

Changes in assets and liabilities:

Accounts receivable, net 114   280

Prepaid expenses and other assets 54   46

Inventory 6   ( 8 )

Right-of-use assets, operating leases 11   9

Accounts payable ( 120 ) ( 156 )

Accrued liabilities 464   ( 381 )

Deferred revenue 5   ( 29 )

Operating lease liabilities ( 7 ) ( 5 )

Other liabilities 26   33

Net cash used in operating activities ( 630 ) ( 1,037 )

Investing activities

Purchases of marketable securities ( 1,348 ) ( 1,764 )

Proceeds from maturities of marketable securities 732   1,933

Proceeds from sales of marketable securities 602   688

Purchases of property, plant and equipment ( 62 ) ( 117 )

Purchase of intangible asset —   ( 10 )

Net cash (used in) provided by investing activities ( 76 ) 730

Financing activities

Proceeds from issuance of common stock through equity plans 19   3

Tax payments related to net share settlements on equity awards ( 2 ) ( 1 )

Changes in financing lease liabilities —   2

Net cash provided by financing activities 17   4

Effect of changes in exchange rates on cash and cash equivalents 1   —

Net decrease in cash, cash equivalents and restricted cash ( 688 ) ( 303 )

Cash, cash equivalents and restricted cash, beginning of year 2,597   1,929

Cash, cash equivalents and restricted cash, end of period $ 1,909   $ 1,626

Non-cash investing and financing activities

Purchases of property and equipment included in accounts payable and accrued liabilities $ 35   $ 50

Purchases of intangible asset included in accounts payable and accrued liabilities

74   —

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

9

Table of Contents

MODERNA, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(Unaudited)

1. Description of the Business

Moderna, Inc. (collectively, with its consolidated subsidiaries, any of Moderna, we, us, our or the Company) is a biotechnology company advancing a new class of medicines made of messenger RNA (mRNA). mRNA medicines are designed to direct the body’s cells to produce intracellular, membrane or secreted proteins that have a therapeutic or preventive benefit with the potential to address a broad spectrum of diseases. Our platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, providing us the capability to pursue in parallel a robust pipeline of new development candidates. We are developing medicines across infectious disease vaccines, oncology therapeutics and rare disease therapeutics.

Since our founding in 2010, we have transformed from a research-stage company advancing programs in the field of mRNA to a commercial enterprise with a diverse clinical portfolio of vaccines and therapeutics across several modalities, a broad intellectual property portfolio and integrated manufacturing capabilities that allow for rapid clinical and commercial production at scale. As of March 31, 2026, we had three commercial products—Spikevax ® and mNEXSPIKE®, our COVID vaccines, and mRESVIA ® , our vaccine against respiratory syncytial virus (RSV). Additionally, we have a diverse development pipeline of 25 development candidates across our 35 development programs currently in clinical studies.

2. Summary of Basis of Presentation and Recent Accounting Standards

Basis of Presentation and Principles of Consolidation

The accompanying unaudited condensed consolidated financial statements that accompany these notes have been prepared in accordance with U.S. generally accepted accounting principles (GAAP) and applicable rules and regulations of the Securities and Exchange Commission (SEC) for interim financial reporting, consistent in all material respects with those applied in our Annual Report on Form 10-K for the year ended December 31, 2025 (2025 Form 10-K). Any reference in these notes to applicable guidance is meant to refer to the authoritative accounting principles generally accepted in the United States as found in the Accounting Standards Codification (ASC) and Accounting Standards Update (ASU) of the Financial Accounting Standards Board (FASB). This report should be read in conjunction with the audited consolidated financial statements in our 2025 Form 10-K.

The condensed consolidated financial statements include Moderna, Inc. and its subsidiaries. All intercompany transactions and balances have been eliminated in consolidation. The significant accounting policies used in the preparation of these condensed consolidated financial statements for the three months ended March 31, 2026 are consistent with those described in our 2025 Form 10-K. The results of operations for the three months ended March 31, 2026 are not necessarily indicative of the operating results to be expected for the full fiscal year or future operating periods. We anticipate seasonal fluctuations in demand for our COVID and RSV vaccines, with higher sales expected during the fall and winter seasons.

Use of Estimates

We have made estimates and judgments affecting the amounts reported in our condensed consolidated financial statements and the accompanying notes. We base our estimates on historical experience and various relevant assumptions that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting periods that are not readily apparent from other sources. Changes in our estimates are recorded in the financial results of the period in which the new information becomes available. The actual results that we experience may differ materially from our estimates.

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Comprehensive Income (Loss)

Comprehensive income (loss) includes net income (loss) and other comprehensive income/loss for the period. Other comprehensive income/loss consists of unrealized gains/losses on our investments, derivatives designated as hedging instruments, foreign currency translation, and pension and postretirement obligation adjustments. Total comprehensive income (loss) for all periods presented has been disclosed in the condensed consolidated statements of comprehensive income (loss).

The components of accumulated other comprehensive income (loss) for the three months ended March 31, 2026 were as follows (in millions):

Unrealized Gains (losses) on Available-for-Sale Debt Securities

Pension and Postretirement Obligation Adjustments

Gains (Losses) on Foreign Currency Translation Total

Accumulated other comprehensive income, balance at December 31, 2025 $ 38   $ 4   $ 3   $ 45

Other comprehensive loss ( 17 ) —   ( 3 ) ( 20 )

Accumulated other comprehensive income, balance at March 31, 2026 $ 21   $ 4   $ —   $ 25

Restricted Cash

We include our restricted cash balance in the cash, cash equivalents and restricted cash reconciliation of operating, investing and financing activities in the condensed consolidated statements of cash flows.

The following table provides a reconciliation of cash, cash equivalents and restricted cash in the condensed consolidated balance sheets that sum to the total of the same such amounts shown in the condensed consolidated statements of cash flows (in millions):

March 31,

2026 2025

Cash and cash equivalents $ 1,908   $ 1,623

Restricted cash (1)

—   1

Restricted cash, non-current (2)

1   2

Total cash, cash equivalents and restricted cash shown in the condensed consolidated

statements of cash flows

$ 1,909   $ 1,626

_______

(1) Included in prepaid expenses and other current assets in the condensed consolidated balance sheets.

(2) Included in other non-current assets in the condensed consolidated balance sheets.

Recently Issued Accounting Standards

From time to time, new accounting pronouncements are issued by the FASB or other standard setting bodies and adopted by us as of the specified effective date. Except as noted below, we believe that the impact of recently issued standards that are not yet effective will not have a material impact on our condensed consolidated financial statements and disclosures.

In November 2024, the FASB issued ASU 2024-03, Income Statement - Reporting Comprehensive Income - Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses. This ASU requires entities to disclose, on an annual and interim basis, disaggregated information in the footnotes related to certain expense categories included in income statement line items. Specifically, entities are expected to provide tabular disclosures for prescribed categories such as inventory purchases, employee compensation, depreciation, and intangible asset amortization for each relevant expense caption. The standard also requires disclosure of total selling expenses and a definition of those expenses in annual filings. Any remaining amounts not quantitatively disclosed are expected to be described qualitatively. This ASU is effective for fiscal years beginning after December 15, 2026 and interim periods beginning after December 15, 2027. Early adoption permitted, and the standard may be applied on a prospective or retrospective basis. We are currently assessing the impact that this new accounting standard will have on our consolidated financial statement disclosures.

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In September 2025, the FASB issued ASU No. 2025-06, Intangibles - Goodwill and Other - Internal-Use Software (Subtopic 350-40): Targeted Improvements to the Accounting for Internal-Use Software. This ASU makes targeted amendments to the accounting for and disclosure of software costs under ASC 350-40. The amendments modernize the guidance to reflect current software development practices, including nonlinear development approaches, and remove references to “development stages.” Under the ASU, the following two criteria must be met for entities to begin capitalizing software costs: (1) management, with the relevant authority, implicitly or explicitly authorizes and commits to funding a computer software project, and (2) it is probable that the project will be completed and the software will be used to perform the function intended (referred to as the “probable-to-complete recognition threshold”). The ASU clarifies that this threshold would not be met when there is “significant uncertainty associated with the development activities of the software (referred to as ‘significant development uncertainty’).” The new standard is effective for all entities for annual reporting periods beginning after December 15, 2027, and for interim reporting periods within those fiscal years. Early adoption is permitted, and entities may apply the amendments prospectively, retrospectively, or using a modified prospective transition approach. We are currently evaluating the impact that this new accounting standard will have on our consolidated financial statements and disclosures.

In September 2025, the FASB issued ASU No. 2025-07, Derivatives and Hedging (Topic 815) and Revenue from Contracts with Customers (Topic 606): Derivatives Scope Refinements and Scope Clarification for Share-Based Noncash Consideration From a Customer in a Revenue Contract. This ASU expands the scope exceptions in the derivatives guidance to exclude certain non-exchange-traded contracts with underlyings based on the operations or activities of one of the parties to the contract, including the occurrence or nonoccurrence of an event specific to those operations or activities. The ASU also clarifies that share-based noncash consideration received from a customer in exchange for goods or services should be accounted for as noncash consideration under ASC 606 unless and until the entity’s right to receive or retain such consideration becomes unconditional. The ASU is effective for annual reporting periods beginning after December 15, 2026, including interim periods within those annual reporting periods. Early adoption is permitted. We are currently evaluating the impact that adoption of this new accounting standard will have on our consolidated financial statements and disclosures.

In December 2025, the FASB issued ASU No. 2025-10, Government Grants (Topic 832): Accounting for Government Grants Received by Business Entities. This ASU establishes guidance on the recognition, measurement, presentation, and disclosure of government grants received by business entities. The guidance defines a government grant as a transfer of a monetary asset or a tangible nonmonetary asset from a government to a business entity other than in an exchange transaction and excludes transactions within the scope of other U.S. GAAP. Under the ASU, government grants are classified as either grants related to an asset or grants related to income, and recognition is permitted only when it is probable that the entity will comply with the conditions attached to the grant and that the grant will be received. The ASU permits alternative presentation approaches depending on the nature of the grant and requires disclosures regarding the nature of the grant, affected financial statement line items, and significant terms and conditions. The ASU is effective for public business entities for annual reporting periods beginning after December 15, 2028, including interim periods within those annual reporting periods. Early adoption is permitted, and the standard may be applied on a modified prospective, modified retrospective, or full retrospective basis. We are currently evaluating the impact of this new accounting standard and do not expect its adoption to have a material impact on our consolidated financial statements and disclosures.

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3. Net Product Sales

Net product sales by customer geographic location were as follows (in millions):

Three Months Ended March 31,

2026 2025

United States $ 73   $ 31

Europe 239   —

Rest of world 40   55

Total $ 352   $ 86

Net product sales by product type were as follows (in millions):

Three Months Ended March 31,

2026 2025

COVID (1)

$ 345   $ 84

RSV

7   2

Total $ 352   $ 86

_______

(1) Includes sales of Spikevax and mNEXSPIKE.

As of March 31, 2026, we have three commercial products, our COVID vaccines, Spikevax and mNEXSPIKE, and our RSV vaccine, mRESVIA. mRESVIA was approved by the FDA in May 2024 for adults aged 60 years and older, and in June 2025, the approved use was expanded to include adults aged 18 through 59 years who are at increased risk for lower respiratory tract disease caused by RSV. In May 2025, mNEXSPIKE was approved for use in adults aged 65 years and older, as well as individuals aged 12 through 64 years with at least one underlying risk factor. We launched commercial sales of mNEXSPIKE in the third quarter of 2025.

We sell our COVID and RSV vaccines to the commercial market as well as to foreign governments and international organizations. In the U.S., our COVID and RSV vaccines are sold primarily to wholesalers and distributors, and to a lesser extent, directly to retailers and healthcare providers. Wholesalers and distributors typically do not make upfront payments to us. Net product sales are recognized net of estimated wholesaler chargebacks, invoice discounts for prompt payments and pre-orders, provisions for sales returns and government rebates, and other related deductions.

The following table summarizes product sales provision adjustments for the periods presented (in millions):

Three Months Ended March 31,

2026 2025

Gross product sales $ 350   $ 105

Product sales provision:

Wholesaler chargebacks, discounts and fees

11   ( 22 )

Returns, rebates and other fees

( 9 ) 3

Total product sales provision adjustments

$ 2   $ ( 19 )

Net product sales $ 352   $ 86

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The following table summarizes the activities related to product sales provision recorded as accrued liabilities for the three months ended March 31, 2026 (in millions):

Returns and other fees

Balance at December 31, 2025 $ ( 509 )

Provision related to sales made in current period

( 9 )

Provision related to sales made in prior periods

Payments and returns related to sales made in current period —

Payments and returns related to sales made in prior year

48

Balance at March 31, 2026 $ ( 470 )

4. Other Revenue

The following table summarizes other revenue for the periods presented (in millions):

Three Months Ended March 31,

2026 2025

Stand-ready manufacturing revenue

$ 32   $ 12

Collaboration revenue ( Note 5 )

5   1

Grant revenue —   1

Licensing and royalty revenue

—   8

Total other revenue $ 37   $ 22

5. Collaboration Agreements and Research and Development Funding Arrangement

Merck – Individualized Neoantigen Therapy (Intismeran Autogene)

In June 2016, we entered into a Collaboration and License Agreement, which was subsequently amended in 2018, with Merck & Co., Inc. (Merck) for the development and commercialization of individualized neoantigen therapy (INT), which has been assigned the generic name intismeran autogene.

In September 2022, Merck exercised its option for intismeran, including mRNA-4157, pursuant to the terms of the agreement and in October 2022 paid us an option exercise fee of $ 250  million. Following this exercise, the Merck Participation Term commenced. Pursuant to the agreement, we and Merck have agreed to collaborate on development and potential commercialization of intismeran, with costs and any profits or losses generally shared equally on a worldwide basis, subject to certain exceptions as outlined in the agreement. During the development phase, we are primarily responsible for process development and the manufacture of intismeran materials, while Merck generally leads clinical trials. We concluded that the collaboration arrangement under the Merck Participation Term is within the scope of ASC 808. For the three months ended March 31, 2026 and 2025, we recognized expenses, net of Merck's reimbursements, of $ 101  million and $ 104  million, respectively, related to the INT collaboration under the Merck Participation Term. Additionally, for the three months ended March 31, 2026 and 2025, the net cost recovery for capital expenditures was $ 1  million and $ 12  million, respectively. These amounts were applied to reduce the capitalized cost of the assets.

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Recordati –Propionic Acidemia Therapeutic

In January 2026, we entered into a collaboration agreement with Recordati S.p.A. (Recordati) to advance the development and commercialization of our investigational propionic acidemia therapeutic, mRNA-3927. Under the terms of the agreement, we granted Recordati an exclusive, royalty-bearing license to develop and commercialize the licensed product (mRNA-3927) worldwide, we will perform and continue to lead clinical development activities through approval, and Recordati will lead global commercialization upon approval. The transaction closed on March 16, 2026, and we are entitled to receive a $ 50  million upfront payment. As of March 31, 2026, we recorded a receivable and deferred revenue for this amount, which is expected to be recognized as collaboration revenue over time. In addition, we are eligible to receive up to $ 110  million in development and regulatory milestones, as well as additional commercial and sales milestones and tiered royalties on net sales.

We have other collaborative and licensing arrangements that we do not consider to be individually significant to our business at this time. Pursuant to these agreements, we may be required to make upfront payments and payments upon achievement of various development, regulatory and commercial milestones, which in the aggregate could be significant. Future milestone payments, if any, will be reflected in our consolidated financial statements when the corresponding events have occurred. In addition, we may be required to pay significant royalties on future sales if products related to these arrangements are commercialized.

Development and Commercialization Funding Arrangement with Blackstone Life Sciences (Blackstone)

In March 2024, we entered into a development and commercialization funding arrangement with Blackstone, under which Blackstone has committed to providing up to $ 750  million in funding to us. This funding supports the development of our investigational mRNA-based influenza vaccine. Contingent upon regulatory approval in the U.S. and only if the approval is dependent on data from the funded activities, Blackstone will be entitled to receive low single-digit percentage royalties and up to $ 750  million in sales milestone payments. These payments are based on net sales of our future influenza and combination vaccines, with sales milestone payments contingent upon achieving specified cumulative net sales targets.

Given the substantive transfer of financial risk to Blackstone, we account for this arrangement as an obligation to conduct research and development activities. The funding is recognized as a reduction to the expenses of our mRNA-based influenza program. This reduction is recognized proportionally as the related costs are incurred, based on an input method. For the three months ended March 31, 2026 and 2025, we recorded expense reductions of $ 50  million and $ 90  million, respectively.

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6. Financial Instruments

Cash and Cash Equivalents and Investments

The following tables summarize our cash, cash equivalents, and available-for-sale securities by significant investment category as of March 31, 2026 and December 31, 2025 (in millions):

March 31, 2026

Amortized

Cost Unrealized

Gains Unrealized

Losses Estimated Fair Value Cash and

Cash

Equivalents Current

Marketable

Securities Non-

Current

Marketable

Securities

Cash and cash equivalents $ 1,908   $ —   $ —   $ 1,908   $ 1,908   $ —   $ —

Available-for-sale:

Certificates of deposit 61   —   —   61   —   61   —

U.S. treasury bills 610   —   —   610   —   610   —

U.S. treasury notes 2,230   1   ( 5 ) 2,226   —   1,233   993

Corporate debt securities 2,599   2   ( 6 ) 2,595   —   1,391   1,204

Government debt securities 56   —   —   56   —   2   54

Total $ 7,464   $ 3   $ ( 11 ) $ 7,456   $ 1,908   $ 3,297   $ 2,251

December 31, 2025

Amortized

Cost Unrealized

Gains Unrealized

Losses Estimated Fair Value Cash and

Cash

Equivalents Current

Marketable

Securities Non-

Current

Marketable

Securities

Cash and cash equivalents $ 2,595   $ —   $ —   $ 2,595   $ 2,595   $ —   $ —

Available-for-sale:

Certificates of deposit 91   —   —   91   —   86   5

U.S. treasury bills 653   —   —   653   —   653   —

U.S. treasury notes 2,188   5   ( 3 ) 2,190   —   1,185   1,005

Corporate debt securities 2,535   6   ( 1 ) 2,540   —   1,250   1,290

Government debt securities 66   —   —   66   —   30   36

Total $ 8,128   $ 11   $ ( 4 ) $ 8,135   $ 2,595   $ 3,204   $ 2,336

The amortized cost and estimated fair value of available-for-sale securities by contractual maturity as of March 31, 2026 and December 31, 2025 were as follows (in millions):

March 31, 2026

Amortized

Cost Estimated

Fair Value

Due in one year or less $ 3,297   $ 3,297

Due after one year through five years 2,259   2,251

Total $ 5,556   $ 5,548

December 31, 2025

Amortized

Cost Estimated

Fair Value

Due in one year or less $ 3,199   $ 3,204

Due after one year through five years 2,334   2,336

Total $ 5,533   $ 5,540

In accordance with our investment policy, we place investments in investment grade securities with high credit quality issuers, and generally limit the amount of credit exposure to any one issuer. We evaluate securities for impairment at the end of each reporting period. Impairment is evaluated considering numerous factors, and their relative significance varies depending on the situation.

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Factors considered include whether a decline in fair value below the amortized cost basis is due to credit-related factors or non-credit-related factors, the financial condition and near-term prospects of the issuer, and our intent and ability to hold the investment to allow for an anticipated recovery in fair value. Any impairment that is not credit related is recognized in other comprehensive loss, net of applicable taxes. A credit-related impairment is recognized as an allowance on the balance sheet with a corresponding adjustment to earnings. We did no t recognize any impairment charges related to available-for-sale securities for the three months ended March 31, 2026 and 2025. We did no t record any credit-related allowance for available-for-sale securities as of March 31, 2026 and December 31, 2025.

The following table summarizes the amount of gross unrealized losses and the estimated fair value for our available-for-sale securities in an unrealized loss position by the length of time the securities have been in an unrealized loss position as of March 31, 2026 and December 31, 2025 (in millions):

Less than 12 Months 12 Months or More Total

Gross Unrealized Losses Estimated Fair Value Gross Unrealized Losses Estimated Fair Value Gross Unrealized Losses Estimated Fair Value

As of March 31, 2026:

U.S. treasury bills $ —   $ 1,023   $ —   $ —   $ —   $ 1,023

U.S. treasury notes ( 3 ) 960   ( 2 ) 236   ( 5 ) 1,196

Corporate debt securities ( 6 ) 1,562   —   35   ( 6 ) 1,597

Government debt securities —   56   —   —   —   56

Total $ ( 9 ) $ 3,601   $ ( 2 ) $ 271   $ ( 11 ) $ 3,872

As of December 31, 2025:

U.S. treasury bills $ —   $ 111   $ —   $ —   $ —   $ 111

U.S. treasury notes ( 1 ) 176   ( 2 ) 235   ( 3 ) 411

Corporate debt securities —   608   ( 1 ) 40   ( 1 ) 648

Government debt securities —   36   —   8   —   44

Total $ ( 1 ) $ 931   $ ( 3 ) $ 283   $ ( 4 ) $ 1,214

As of March 31, 2026 and December 31, 2025, we held 292 and 108 available-for-sale securities, respectively, out of our total investment portfolio that were in a continuous unrealized loss position. We neither intend to sell these investments, nor do we believe that we are more-likely-than-not to conclude we will have to sell them before recovery of their carrying values. We also believe that we will be able to collect both principal and interest amounts due to us at maturity.

Assets and Liabilities Measured at Fair Value on a Recurring Basis

The following fair value hierarchy is used to classify assets and liabilities based on the observable inputs and unobservable inputs used to value the assets and liabilities:

• Level 1: Unadjusted quoted prices in active markets that are accessible at the measurement date for identical, unrestricted assets or liabilities;

• Level 2: Quoted prices for similar assets and liabilities in active markets, quoted prices in markets that are not active, or inputs which are observable, either directly or indirectly, for substantially the full term of the asset or liability; or

• Level 3: Prices or valuation techniques that require inputs that are both significant to the fair value measurement and unobservable (i.e., supported by little or no market activity).

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The following tables summarize our financial assets and liabilities measured at fair value on a recurring basis as of March 31, 2026 and December 31, 2025 (in millions):

Fair value at March 31, 2026 Fair Value Measurement Using

Level 1 Level 2

Assets:

Money market funds $ 595   $ 595   $ —

Certificates of deposit 61   —   61

U.S. treasury bills 1,141   —   1,141

U.S. treasury notes 2,226   —   2,226

Corporate debt securities 2,978   —   2,978

Government debt securities 56   —   56

Equity investments (1)

2   2   —

Derivative instruments

8   —   8

Total $ 7,067   $ 597   $ 6,470

Fair value at December 31, 2025 Fair Value Measurement Using

Level 1 Level 2

Assets:

Money market funds $ 963   $ 963   $ —

Certificates of deposit 91   —   91

U.S. treasury bills 1,445   —   1,445

U.S. treasury notes 2,190   —   2,190

Corporate debt securities 3,163   —   3,163

Government debt securities 66   —   66

Equity Investments (1)

6   6   —

Derivative instruments

1   —   1

Total $ 7,925   $ 969   $ 6,956

Liabilities:

Derivative instruments

$ 4   $ —   $ 4

_______

(1) Investments in publicly traded equity securities with readily determinable fair values are recorded at quoted market prices for identical securities, with changes in fair value recorded in other expense, net, in our condensed consolidated statements of operations.

As of March 31, 2026 and December 31, 2025, we did not have non-financial assets or liabilities measured at fair value on a recurring basis and did not have any Level 3 financial assets or financial liabilities.

For the three months ended March 31, 2026 and 2025, we recognized net losses of $ 2  million and $ 8  million, respectively, on equity investments from changes in fair value of the securities.

Fair Value of Other Financial Instruments

We estimate the fair value of our term loan using Level 2 inputs. The fair value of the term loan approximates its carrying value as of March 31, 2026 and December 31, 2025, as the instrument bears interest at a variable rate that reflects current market rates. See Note 11 for additional information.

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7. Inventory

Inventory as of March 31, 2026 and December 31, 2025 consisted of the following (in millions):

March 31, December 31,

2026 2025

Raw materials $ 94   $ 91

Work in progress 38   29

Finished goods 14   33

Total inventory $ 146   $ 153

Inventory, non-current (1)

$ 117   $ 114

_______

(1) Consisted of raw materials with an anticipated consumption beyond one year. Inventory, non-current is included in other non-current assets in the condensed consolidated balance sheets.

Inventory write-downs as a result of excess, obsolescence, scrap or other reasons, and losses on firm purchase commitments are recorded as a component of cost of sales in our condensed consolidated statements of operations. For the three months ended March 31, 2026 and 2025, inventory write-downs were $ 38  million and $ 42  million, respectively. For the three months ended March 31, 2026, there were no losses on firm purchase commitments. For the three months ended March 31, 2025, losses on firm purchase commitments was $ 10  million.

Inventory write-downs were mainly related to inventory in excess of expected demand, shelf-life expiration and other inventory adjustments. Losses on firm purchase commitments were primarily related to excess raw material purchase commitments that will expire before the anticipated consumption of those raw materials.

As of March 31, 2026 and December 31, 2025, we had inventory on hand of $ 263  million and $ 267  million, respectively, inclusive of inventory for our COVID and RSV vaccines. Our raw materials and work-in-progress inventory have variable shelf lives. We expect that the majority of this inventory will be consumed over the next three years . The shelf life of Spikevax is nine to twelve months . mNEXSPIKE has a shelf life of twelve months . The shelf life of mRESVIA, our RSV vaccine, is eighteen months .

8. Property, Plant and Equipment, Net

Property, plant and equipment, net, as of March 31, 2026 and December 31, 2025 consisted of the following (in millions):

March 31, December 31,

2026 2025

Land and land improvements

$ 77   $ 78

Building and building improvements

1,216   1,183

Manufacturing and laboratory equipment 543   542

Leasehold improvements

408   403

Furniture, fixtures and other 40   39

Computer equipment and software

196   196

Construction in progress

268   298

Right-of-use assets, financing ( Note 10 )

132   132

Total 2,880   2,871

Less: Accumulated depreciation

( 794 ) ( 737 )

Property, plant and equipment, net $ 2,086   $ 2,134

Depreciation and amortization expense related to property, plant and equipment for the three months ended March 31, 2026 and 2025 was $ 56  million and $ 38  million, respectively.

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9. Other Balance Sheet Components

Accounts Receivable, net

Accounts receivable, net, as of March 31, 2026 and December 31, 2025 consisted of the following (in millions):

March 31, December 31,

2026 2025

Accounts receivable $ 203   $ 368

Less: Wholesalers chargebacks, discounts and fees

( 126 ) ( 181 )

Less: Allowance for doubtful accounts

( 6 ) ( 3 )

Accounts receivable, net $ 71   $ 184

Prepaid Expenses and Other Current Assets

Prepaid expenses and other current assets, as of March 31, 2026 and December 31, 2025 consisted of the following (in millions):

March 31, December 31,

2026 2025

Prepaid services $ 131   $ 169

Down payments and prepayments related to manufacturing and materials

55   61

Interest receivable 39   42

Prepaid income tax and income tax receivable

35   41

Value added tax receivable 29   37

Research and development funding receivable ( Note 5 )

7   —

Collaboration receivable 1   13

Other current assets 51   45

Prepaid expenses and other current assets $ 348   $ 408

Other Non-Current Assets

Other non-current assets, as of March 31, 2026 and December 31, 2025 consisted of the following (in millions):

March 31, December 31,

2026 2025

Income tax receivable, non-current

$ 161   $ 161

Inventory, non-current (1)

117   114

Finite-lived intangible assets, net (2)

116   45

Down payments and prepayments, non-current

97   100

Deferred tax assets

82   81

Goodwill

52   52

Other 50   52

Other non-current assets $ 675   $ 605

_______

(1) Consisted of raw materials with an anticipated consumption beyond one year.

(2) Includes a $ 72  million intangible asset related to a license recognized in connection with the settlement agreement with Arbutus and Genevant. See Note 12 for additional details.

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Accrued Liabilities

Accrued liabilities, as of March 31, 2026 and December 31, 2025 consisted of the following (in millions):

March 31, December 31,

2026 2025

Royalties (1)

$ 967   $ 31

Provisions related to product sales ( Note 3 )

470   509

Compensation-related 108   420

Other external goods and services 82   57

Development operations 81   106

Manufacturing 79   140

Clinical trials 46   20

Property, plant and equipment 31   45

Raw materials 27   30

Commercial

16   23

Loss on future firm purchase commitments (2)

5   5

Accrued liabilities $ 1,912   $ 1,386

______

(1) Includes $ 950  million related to the litigation settlement with Arbutus and Genevant ( Note 12 ).

(2) Related to losses that are expected to arise from firm, non-cancellable, commitments for future raw material purchases ( Note 7 ).

Other Current Liabilities

Other current liabilities, as of March 31, 2026 and December 31, 2025 consisted of the following (in millions):

March 31, December 31,

2026 2025

Estimated reimbursements to wholesalers and distributors

$ 111   $ 84

Lease liabilities - financing ( Note 10 )

31   25

Lease liabilities - operating ( Note 10 )

19   17

Research and development funding liability ( Note 5 )

—   43

Other 59   16

Other current liabilities $ 220   $ 185

Other Non-Current Liabilities

Other non-current liabilities, as of March 31, 2026 and December 31, 2025 consisted of the following (in millions):

March 31, December 31,

2026 2025

Tax liabilities

$ 253   $ 249

Other

30   36

Other non-current liabilities

$ 283   $ 285

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Deferred Revenue

The following table summarizes the activities in deferred revenue for the three months ended March 31, 2026 (in millions ):

December 31, 2025 Additions Deductions March 31, 2026

Other revenue $ 145   $ 53   $ ( 37 ) $ 161

Net product sales

107   —   ( 12 ) 95

Total deferred revenue $ 252   $ 53   $ ( 49 ) $ 256

10. Leases

We have entered into various long-term, non-cancelable lease arrangements for our facilities and equipment, expiring at various times through 2039. Certain of these arrangements have free rent periods or escalating rent payment provisions. We recognize lease costs under such arrangements on a straight-line basis over the life of the lease. We lease various parcels of land, office, lab, and manufacturing spaces across the globe for our business operations.

Our primary leased campus is our Moderna Science Center (MSC), located in Cambridge, which serves as our headquarters. The MSC, comprising approximately 462,000 square feet, includes our principal executive office and additional office and laboratory spaces. The MSC lease commenced in the third quarter of 2023 and has a term of 15 years, with options for two additional seven-year extensions.

Operating and financing lease right-of-use assets and lease liabilities as of March 31, 2026 and December 31, 2025 were as follows (in millions):

March 31, December 31,

2026 2025

Assets:

Right-of-use assets, operating, net (1) (2)

$ 706   $ 719

Right-of-use assets, financing, net (3) (4)

36   42

Total $ 742   $ 761

Liabilities:

Current:

Operating lease liabilities (5)

$ 19   $ 17

Financing lease liabilities (5)

31   25

Total current lease liabilities 50   42

Non-current:

Operating lease liabilities, non-current 645   653

Financing lease liabilities, non-current 13   20

Total non-current lease liabilities 658   673

Total $ 708   $ 715

_______

(1) These assets are real estate related assets, which include land, office, manufacturing, and laboratory spaces.

(2) Net of accumulated amortization.

(3) These assets are related to contract manufacturing service agreements.

(4) Included in property, plant and equipment in the condensed consolidated balance sheets, net of accumulated depreciation.

(5) Included in other current liabilities in the condensed consolidated balance sheets.

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Future minimum lease payments under our non-cancelable lease agreements as of March 31, 2026, were as follows (in millions):

Fiscal Year

Operating Leases Financing Leases

2026 (remainder of the year) $ 47   $ 26

2027 78   20

2028 81   —

2029 82   —

2030 80   —

Thereafter 679   —

Total minimum lease payments

1,047   46

Less amounts representing interest or imputed interest ( 383 ) ( 2 )

Present value of lease liabilities

$ 664   $ 44

11. Credit Agreement

In November 2025, we entered into a Credit and Guaranty Agreement (the Credit Agreement) with lenders led by Ares Capital Corporation, as administrative agent. The Credit Agreement provides for a senior secured term loan facility with aggregate term loan commitments of $ 1.5  billion, consisting of a $ 600 million initial term loan, which was funded at closing, and $ 900 million of delayed draw term loan commitments. The initial term loan matures on November 24, 2030. The delayed draw term loan commitments consist of (1) a $ 400 million delayed draw term loan facility (DDTL-1), which is available, subject to customary conditions, through November 24, 2027, and (2) a $ 500 million delayed draw term loan facility (DDTL-2), which is available, subject to customary conditions and the achievement of specified regulatory approval milestones for certain product candidates, through November 24, 2028.

Borrowings under the Credit Agreement bear interest at a variable rate equal to, at our option, (i) Term SOFR plus a margin of 5.50 % or (ii) a base rate plus a margin of 4.50 %. The base rate is calculated as the highest of (a) the Wall Street Journal prime rate, (b) the federal funds rate plus one half of one percent and (c) Term SOFR plus one percent. We are also required to pay commitment fees on the undrawn portions of DDTL-1 and DDTL-2. The interest rate applicable to the initial term loan was approximately 9.17 % and 9.38 % as of March 31, 2026 and December 31, 2025, respectively.

The obligations under the Credit Agreement are guaranteed by certain of our subsidiaries and are secured by a first-priority lien on substantially all of our assets, in each case subject to customary exceptions and limitations. The Credit Agreement is subject to compliance with customary representations and warranties, affirmative covenants, restrictive covenants and events of default. The restrictive covenants, subject to specified limitations and exceptions, limit, among other things, our ability to incur additional indebtedness and liens, make certain investments, engage in certain fundamental changes, dispose of assets and make restricted payments. Events of default under the Credit Agreement include, among others, nonpayment of principal, interest or other amounts when due, failure to comply with covenants (subject to applicable notice and cure periods), breaches of certain representations and warranties, the occurrence of certain significant adverse events and certain insolvency-related events. The Credit Agreement also includes a financial covenant requiring us to maintain minimum cash and cash equivalents (as defined in the Credit Agreement, which primarily consist of our cash, cash equivalents, and available-for-sale securities) as of the last business day of each week of at least $ 500 million, increasing to $ 750 million if more than $ 1.0  billion is drawn under the Credit Agreement. The financial covenant is not required to be tested at any time that the trailing 30 -day average market capitalization of the Company exceeds $ 5.0  billion and is subject to a customary equity cure. As of March 31, 2026 and December 31, 2025, we were in compliance with the applicable terms and covenants under the Credit Agreement.

As of March 31, 2026 and December 31, 2025, the initial term loan had an outstanding principal balance of $ 600 million and a carrying amount of $ 590 million at each date, net of unamortized original issue discount and debt issuance costs, which was classified as long-term debt in our condensed consolidated balance sheet. No amounts had been drawn under DDTL-1 or DDTL-2. The principal amount of $ 600 million is due in full at maturity, and no principal payments are required prior to that date.

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12. Commitments and Contingencies

Legal Proceedings

We are a party to various legal proceedings and claims. Accruals are recognized for legal matters when a loss is both probable and reasonably estimable. As of March 31, 2026, no material contingent liabilities have been recognized. If a material loss is reasonably possible and we can estimate the amount or range of the loss, we disclose such information. Unless otherwise noted, either the outcome of these matters is not expected to be material, or the potential loss cannot be reasonably estimated.

From time to time, we may be a party to litigation, arbitration, or other legal proceedings in the course of our business. The outcome of such matters is inherently uncertain and often involves significant judgment in assessing risk and estimating potential exposure. While we do not currently expect any pending proceedings to have a material adverse effect on our financial position, results of operations, or cash flows, there can be no assurance that future developments will not have a material impact.

On March 3, 2026, we entered into a settlement agreement with Arbutus Biopharma Corporation (Arbutus) and Genevant Sciences GmbH (Genevant, and with Arbutus, Arbutus/Genevant) resolving all litigation worldwide, including between the parties in the U.S. District Court for the District of Delaware. The settlement resolves all worldwide Arbutus/Genevant litigation related to Spikevax and mRESVIA and provides certainty going forward for our full infectious disease portfolio, including mNEXSPIKE, mCOMBRIAX and our future vaccine pipeline, with no future royalties owed. Under the terms of the agreement, we agreed to make a lump sum payment of $ 950  million, which is payable in the third quarter of 2026. In the three months ended March 31, 2026, we recorded $ 876  million in cost of sales and capitalized $ 74  million as an intangible asset on the settlement date, representing the estimated value attributed to a license to certain intellectual property rights, which is being amortized on a straight-line basis over an estimated useful life of approximately three years . As of March 31, 2026, the carrying value of the intangible asset was $ 72  million. Consistent with the terms of the settlement agreement, we have appealed the District Court’s decision related to 28 U.S.C. § 1498 to the Federal Circuit Court of Appeals and could be required to make an additional payment of up to $ 1.3  billion pending on the outcome. As of March 31, 2026, no accrual has been recorded for this amount as a loss is not considered probable.

The following summarizes our other significant legal proceedings and matters outstanding as of March 31, 2026.

We have brought patent-infringement actions against Pfizer Inc. (Pfizer), BioNTech SE (BioNTech) and related entities in the U.S., Germany, the Netherlands, the UK, Ireland and Belgium concerning our mRNA platform technology and disease-specific vaccine designs. Pfizer and BioNTech have commenced actions or asserted defenses seeking to revoke our patents in these jurisdictions.

GlaxoSmithKline Biologicals SA (GSK) has filed two complaints against us in the U.S. District Court for the District of Delaware asserting certain patents owned by GSK. GSK has also filed two patent-infringement lawsuits against us in the UPC concerning liposomes and modified liposomes for RNA delivery.

Northwestern University has filed a complaint against us in the U.S. District Court for the District of Delaware asserting U.S. patents concerning lipid nanoparticle technology.

Bayer CropSciences LLC, Monsanto Company, and Monsanto Technology, LLC have filed a complaint against us in the U.S. District Court for the District of Delaware asserting a U.S. patent directed to methods of modifying gene sequences.

mNG Bio, LLC has filed a complaint against us in the U.S District Court for the District of Massachusetts asserting a U.S. patent directed to a yellow-green fluorescent protein.

BioNTech SE has filed a complaint against us in the U.S. District Court for the District of Delaware asserting a U.S. patent directed to modified mRNA compositions encoding a spike protein fragment.

CureVac SE and CureVac Manufacturing GmbH have filed a complaint against us in the U.S. District Court for the District of Delaware asserting U.S. patents directed to RNA production methods and compositions with RNA encoding modified SARS-CoV-2 spike protein.

We are subject to shareholder class action and shareholder derivative litigation pending in the U.S. District Court for the District of Massachusetts related to statements about our RSV vaccine (mRNA-1345).

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Indemnification Obligations

As permitted under Delaware law, we indemnify our officers, directors, and employees for certain events, occurrences while the officer, or director is, or was, serving at our request in such capacity. The term of the indemnification is for the officer’s or director’s lifetime.

We have standard indemnification arrangements in our leases for laboratory and office space that require us to indemnify the landlord against any liability for injury, loss, accident, or damage from any claims, actions, proceedings, or costs resulting from certain acts, breaches, violations, or non-performance under our leases.

We enter into indemnification provisions under our agreements with counterparties in the ordinary course of business, typically with business partners, contractors, clinical sites and customers. Under these provisions, we generally indemnify and hold harmless the indemnified party for losses suffered or incurred by the indemnified party as a result of our activities. These indemnification provisions generally survive termination of the underlying agreement. The maximum potential amount of future payments we could be required to make under these indemnification provisions is unlimited.

Through the three months ended March 31, 2026 and the year ended December 31, 2025, we had no t experienced any material losses related to these indemnification obligations, and no material claims were outstanding. We do not expect significant claims related to these indemnification obligations and, consequently, concluded that the fair value of these obligations is negligible, and no related reserves were established.

Licenses to Patented Technology

We have patent license agreements with Cellscript, LLC and its affiliate, mRNA RiboTherapeutics, Inc., and the National Institute of Allergy and Infectious Diseases (NIAID), an Institute of the National Institutes of Health (NIH). Under these agreements, we are required to pay royalties and certain milestone payments. For further information on our licensing and royalty payments, please refer to our 2025 Form 10-K under the heading “Business—Intellectual Property—In-licensed intellectual property” and Note 12 to our consolidated financial statements contained therein.

In January 2025, we entered into a non-exclusive patent license agreement with NIAID to license certain patent rights related to the development of mRNA-based vaccines for the prevention or treatment of RSV infection. Upon execution of the agreement, we made a total payment of $ 10  million, which was capitalized as an intangible asset and is amortized to cost of sales on a straight-line basis over the estimated useful life of the licensed patents. In addition, we are obligated to pay low single-digit royalties on future net sales of licensed products.

For the three months ended March 31, 2026 and 2025, we recognized $ 895  million and $ 5  million, respectively, of royalty expenses, including amortization of certain intangible assets. Royalty expenses for the three months ended March 31, 2026 include $ 878  million related to the litigation settlement with Arbutus and Genevant. These royalty expenses were recorded to cost of sales in our condensed consolidated statements of operations.

Additionally, we have other in-license agreements with third parties which require us to make future development, regulatory and commercial milestone payments and sales-based royalties for specified products associated with the agreements. The achievement of these milestones have not yet occurred as of March 31, 2026.

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13. Stock-Based Compensation and Share Repurchase Programs

Stock-Based Compensation

The following table presents the components and classification of stock-based compensation expense for the three months ended March 31, 2026 and 2025 as follows (in millions):

Three Months Ended March 31,

2026 2025

Options

$ 24   $ 39

Restricted Stock Units (RSUs)

75   71

Performance Stock Units (PSUs)

3   1

Employee Stock Purchase Plan (ESPP) 2   4

Total

$ 104   $ 115

Cost of sales $ 3   $ 7

Research and development 64   69

Selling, general and administrative 37   39

Total

$ 104   $ 115

As of March 31, 2026, there was $ 978  million of total unrecognized compensation cost related to unvested stock-based compensation with respect to options, RSUs and PSUs granted. That cost is expected to be recognized over a weighted-average period of 2.9 years as of March 31, 2026.

Share Repurchase Programs

As of March 31, 2026, $ 1.7  billion of our Board of Directors’ authorization for repurchases of our common stock (the 2022 Repurchase Programs) remains outstanding, with no expiration date. There were no shares repurchased during the three months ended March 31, 2026 or 2025.

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14. Income Taxes

The following table summarizes our income tax expense for the periods presented (in millions, except for percentages):

Three Months Ended March 31,

2026 2025

Loss before income taxes $ ( 1,334 ) $ ( 964 )

Provision for income taxes $ 9   $ 7

Effective tax rate ( 0.7 ) % ( 0.7 ) %

The effective tax rate for the three months ended March 31, 2026 was higher than the statutory rate, primarily due to our global valuation allowance, which limits our ability to recognize tax benefits from the loss. The higher effective tax rate was also impacted by certain of our foreign subsidiaries that have taxable income, while we incurred a net loss before income taxes in other jurisdictions. The effective tax rate for the three months ended March 31, 2026 was consistent with the same period in 2025, primarily due to the continued maintenance of global valuation allowance. For additional details regarding our deferred tax assets and the policies governing our valuation allowance, please refer to Note 14 to our consolidated financial statements in our 2025 Form 10-K.

We periodically reassess the need for valuation allowances on our deferred tax assets, considering both positive and negative evidence to evaluate whether it is more likely than not that all or a portion of such assets will not be realized. Significant management judgment is required in assessing the realizability of our deferred tax assets. In the event that actual results differ from our estimates, we adjust our estimates in future periods and we may need to modify our valuation allowance, which could materially impact our financial position and results of operations.

We file income tax returns in the U.S. and various state, local and foreign jurisdictions. The income tax returns of all material taxing jurisdictions remain open to tax examination for all tax years since our date of incorporation in those jurisdictions. As of March 31, 2026, we are under audit in various U.S. and foreign jurisdictions. No adjustments to our tax positions have been proposed at this time.

15. Net loss per Share

The computation of basic earnings (loss) per share (EPS) is based on the weighted-average number of our common shares outstanding. The computation of diluted EPS is based on the weighted-average number of our common shares outstanding and potential dilutive common shares during the period as determined by using the treasury stock method.

Basic and diluted EPS for the three months ended March 31, 2026 and 2025 were calculated as follows (in millions, except per share data):

Three Months Ended March 31,

2026 2025

Numerator:

Net loss $ ( 1,343 ) $ ( 971 )

Denominator:

Basic and diluted weighted-average common shares outstanding

395   386

Basic and diluted EPS

$ ( 3.40 ) $ ( 2.52 )

Common stock equivalents excluded from the EPS computation above because their inclusion would have been anti-dilutive

45   49

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2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

You should read the following discussion and analysis of our financial condition and results of operations together with our unaudited financial information and related notes included in this Form 10-Q and our consolidated financial statements and related notes and other financial information in our Annual Report on Form 10-K for the fiscal year ended December 31, 2025, which was filed with the Securities and Exchange Commission (the SEC) on February 20, 2026 (the 2025 Form 10-K).

Overview

We are a biotechnology company advancing a new class of medicines made of messenger RNA (mRNA). mRNA medicines are designed to direct the body’s cells to produce intracellular, membrane or secreted proteins that have a therapeutic or preventive benefit with the potential to address a broad spectrum of diseases. Our platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, providing us the capability to pursue in parallel a robust pipeline of new development candidates. We are developing medicines across infectious disease vaccines, oncology therapeutics and rare disease therapeutics.

Since our founding in 2010, we have transformed from a research-stage company advancing programs in the field of mRNA to a commercial enterprise with a diverse clinical portfolio of vaccines and therapeutics across several modalities, a broad intellectual property portfolio and integrated manufacturing capabilities that allow for rapid clinical and commercial production at scale. We currently have four approved products—Spikevax ® and mNEXSPIKE ® , our COVID vaccines; mRESVIA ® , our vaccine against respiratory syncytial virus (RSV); and mCOMBRIAX ® , our flu plus COVID combination vaccine, which was recently approved in Europe for individuals 50 years of age and older. We also have a diverse development pipeline of 25 development candidates across our 35 development programs currently in clinical studies.

Business Highlights

Strategic Collaboration with Recordati

In January 2026, we announced a strategic collaboration with Recordati S.p.A. (Recordati) to advance our investigational propionic acidemia (PA) therapeutic, mRNA-3927, through the final stages of clinical development and, upon approval, global commercialization. The transaction closed on March 16, 2026. Under the agreement, we will continue to lead clinical development of mRNA-3927 through approval, and Recordati will lead commercialization. Recordati has an established global commercial infrastructure and expertise in rare diseases, including PA, which is expected to support commercialization upon approval. mRNA-3927 targets a serious rare metabolic disease with significant unmet medical need and is currently being evaluated in a registrational study that has reached target enrollment, with potential data expected in 2026. Under the terms of the agreement, Recordati agreed to make an upfront payment of $50 million and are we are eligible to receive up to an additional $110 million in development and regulatory milestone payments, in addition to commercial and sales milestones and tiered royalties on net sales.

Strategic Agreement with the Government of Mexico

In February 2026, we signed a memorandum of understanding for a long-term strategic agreement with the Government of Mexico, Laboratorios de Biológicos y Reactivos de Mexico (BIRMEX), and Laboratorios Liomont (Liomont) to support the development of local mRNA manufacturing capabilities and strengthen pandemic preparedness. The agreement includes the supply of our respiratory vaccine portfolio and a technology transfer to Liomont to enable domestic manufacturing of our COVID vaccine, mRNA-1273. In addition, the collaboration is expected to support local clinical research and development activities aligned with Mexico’s public health priorities.

Settlement with Arbutus and Genevant

On March 3, 2026, we entered into a settlement agreement with Arbutus Biopharma Corporation (Arbutus) and Genevant Sciences GmbH (Genevant, and with Arbutus, Arbutus/Genevant) resolving all litigation worldwide, including between the parties in the U.S. District Court for the District of Delaware. The settlement resolves all worldwide Arbutus/Genevant litigation related to Spikevax and mRESVIA and provides certainty going forward for our full infectious disease portfolio, including mNEXSPIKE, mCOMBRIAX and our future vaccine pipeline, with no future royalties owed. Under the terms of the agreement, we agreed to make a lump sum payment of $950 million, which is payable in the third quarter of 2026. Consistent with the terms of the settlement agreement, we have appealed the District Court’s decision related to 28 U.S.C. § 1498 to the Federal Circuit Court of Appeals and could be required to make an additional payment of up to $1.3 billion depending on the outcome.

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European Commission Marketing Authorization for mCOMBRIAX

In April 2026, we received marketing authorization from the European Commission (EC) for mCOMBRIAX (mRNA-1083), our mRNA combination vaccine for the prevention of influenza disease and COVID-19 in individuals 50 years of age and older. The marketing authorization follows a positive opinion from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) and is valid in all 27 European Union member states, as well as Iceland, Liechtenstein and Norway. mCOMBRIAX is our fourth authorized product and further strengthens our respiratory portfolio and commitment to the European Union. The vaccine builds on advances from the clinical development of mNEXSPIKE and mRNA-1010, our investigational seasonal influenza vaccine. mCOMBRIAX will be made available across the European Union, subject to national regulatory and access procedures, and we are working with national authorities to support local access and implementation.

Total Revenue and Net Loss Per Share

For the first quarter of 2026, we recognized total revenue of $389 million, compared to $108 million for the first quarter of 2025. Net loss per share was $(3.40) for the first quarter of 2026, compared to net loss per share of $(2.52) for the first quarter of 2025.

Recent Program Developments

Infectious Disease Vaccines

• Seasonal flu + COVID vaccine: We received EC marketing authorization for mCOMBRIAX in the EU and our mRNA-1083 regulatory filings are under review in Canada and Australia. We are awaiting further guidance from the U.S. Food and Drug Administration (FDA) on refiling the submission for mRNA-1083. In addition, we recently presented mRNA-1083 data from a Japanese cohort at the 2026 European Society of Clinical Microbiology and Infectious Diseases (ESCMID) Global Congress.

• Seasonal flu vaccine: The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date for mRNA-1010 of August 5, 2026. Our mRNA-1010 regulatory filings are also under review in Europe, Canada and Australia, and potential approvals are expected to begin in 2026. We recently presented mRNA-1010 revaccination data at the 2026 ESCMID Global Congress.

• Norovirus vaccine: Our ongoing Phase 3 safety and efficacy study of our trivalent vaccine candidate against norovirus (mRNA-1403) is fully enrolled in a second Northern Hemisphere season (2025-2026) with data expected in 2026, subject to case accruals.

Oncology Therapeutics

• Intismeran autogene: We are advancing mRNA-4157 in collaboration with Merck, with nine total Phase 2 and Phase 3 clinical trials underway across multiple tumor types, including melanoma, non-small cell lung cancer (NSCLC), bladder cancer and renal cell carcinoma. This includes the recent initiation of a Phase 3 study of intismeran as monotherapy and in combination with KEYTRUDA QLEX for the treatment of high-risk Stage 1 NSCLC.

Fully enrolled studies include a Phase 3 adjuvant melanoma, a Phase 2 adjuvant renal cell carcinoma, and a Phase 2 adjuvant muscle invasive bladder cancer. We expect Phase 3 adjuvant melanoma data potentially in 2026.

We recently announced an upcoming oral presentation at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting highlighting positive five-year Phase 2b adjuvant melanoma data, which showed a sustained benefit with intismeran in combination with KEYTRUDA, reducing the risk of recurrence or death by 49% compared to KEYTRUDA alone.

• mRNA-4359. Our Phase 1/2 study of mRNA-4359, an investigational wholly-owned cancer antigen therapy, is ongoing. We recently presented mRNA-4359 data at the American Association for Cancer Research (AACR) 2026 Annual Meeting. The Phase 2 portion of the study includes cohorts in first-line metastatic melanoma, second-line+ metastatic melanoma and first-line metastatic NSCLC, and we expect a potential Phase 2 data readout in 2026.

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Rare Disease Therapeutics

• Propionic acidemia (PA) therapeutic: Our investigational therapeutic for PA (mRNA-3927) is in a registrational study and target enrollment has been reached.

• Methylmalonic acidemia (MMA) therapeutic: We are deferring our decision on a pivotal trial for mRNA-3705 until PA registrational data readout.

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Our Pipeline

The following chart shows our current pipeline of 35 development programs across our several modalities.

Abbreviations: CMV, cytomegalovirus; EBV, Epstein-Barr virus; HIV, human immunodeficiency virus; hMPV, human metapneumovirus; MIBC, muscle invasive bladder cancer; NMIBC, non-muscle invasive bladder cancer; NSCLC, non-small cell lung cancer; pCR, pathological complete response; RCC, renal cell carcinoma; RSV, respiratory syncytial virus.

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Results of operations

The following table summarizes our condensed consolidated statements of operations for the periods presented (in millions):

Three Months Ended March 31, Change 2026 vs. 2025

2026 2025 $ %

Revenue:

Net product sales $ 352  $ 86  $ 266  309%

Other revenue 37  22  15  68%

Total revenue 389  108  281  260%

Operating expenses:

Cost of sales 955  90  865  961%

Research and development 649  856  (207) (24)%

Selling, general and administrative 173  212  (39) (18)%

Total operating expenses 1,777  1,158  619  53%

Loss from operations (1,388) (1,050) (338) 32%

Interest income 72  90  (18) (20)%

Other expense, net (18) (4) (14) 350%

Loss before income taxes (1,334) (964) (370) 38%

Provision for income taxes 9  7  2  29%

Net loss $ (1,343) $ (971) $ (372) 38%

Revenue

Net product sales

Net product sales by customer geographic location were as follows (in millions):

Three Months Ended March 31,

2026 2025

United States $ 73  $ 31

Europe 239  —

Rest of world

40  55

Total $ 352  $ 86

Net product sales by product were as follows (in millions):

Three Months Ended March 31,

2026 2025

COVID (1)

$ 345  $ 84

RSV 7  2

Total $ 352  $ 86

_______

(1) Includes sales of Spikevax and mNEXSPIKE.

As of March 31, 2026, we have three commercial products, our COVID vaccines, Spikevax and mNEXSPIKE, and our RSV vaccine, mRESVIA. We launched commercial sales of mNEXSPIKE in the third quarter of 2025.

We sell our COVID vaccines, Spikevax and mNEXSPIKE, to the commercial market as well as to foreign governments and international organizations. In the U.S., our COVID and RSV vaccines are sold primarily to wholesalers and distributors, and to a lesser extent, directly to retailers and healthcare providers. Net product sales are recognized net of estimated wholesaler chargebacks, invoice discounts for prompt payments and pre-orders, provisions for sales returns and government rebates, and other related deductions.

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The following table summarizes product sales provision adjustments for the periods presented (in millions):

Three Months Ended March 31,

2026 2025

Gross product sales $ 350  $ 105

Product sales provision:

Wholesaler chargebacks, discounts and fees

11  (22)

Returns, rebates and other fees

(9) 3

Total product sales provision adjustments

$ 2  $ (19)

Net product sales $ 352  $ 86

Certain agreements may include upfront payments for our vaccine supply, initially recorded as deferred revenue. As of March 31, 2026, we had deferred revenue of $95 million related to product sales, of which $37 million is expected to be realized in less than one year.

Other revenue

Other revenue comprises grant revenue, collaboration revenue, licensing and royalty revenue, and stand-ready manufacturing revenue.

For the three months ended March 31, 2026, total revenue increased by $281 million, or 260%, compared to the same period in 2025, primarily driven by an increase in net product sales. Net product sales increased by $266 million, or 309%, mainly due to higher COVID vaccine sales in international markets, driven by deliveries under long-term strategic partnerships with government entities. Other revenue also increased compared to the same period in 2025, reflecting higher stand-ready manufacturing revenue from facilities under these partnerships, including those that became operational later in 2025.

Product sales are expected to return to growth in 2026, supported by the full-year impact of long-term strategic partnerships with government entities.

Operating expenses

Cost of sales

Cost of sales for the three months ended March 31, 2026 was $955 million, which included third-party royalties of $895 million, inventory write-downs of $38 million, primarily related to our finished and semi-finished COVID vaccine inventory and raw materials relative to updated demand forecasts, as well as shelf-life expiration and other adjustments. Third-party royalties included $878 million related to the litigation settlement with Arbutus and Genevant, as well as amortization of the associated intangible asset. Please refer to Note 12 , Commitments and Contingencies, to our condensed consolidated financial statements for additional information. Inventory write-downs in 2026 reflected a combination of factors, including changes in demand expectations, expiration, scrap and other adjustments. Please refer to Note 7 to our condensed consolidated financial statements for inventory related charges.

Cost of sales for the three months ended March 31, 2026 increased by $865 million, or 961%, compared to the same period in 2025. Cost of sales as a percentage of net product sales and stand-ready manufacturing revenue was 249% for the three months ended March 31, 2026, compared to 92% for the corresponding period in 2025. The increase was primarily driven by litigation settlement-related expenses recognized in the first quarter of 2026. Excluding these expenses, cost of sales and cost of sales as a percentage of net product sales and stand-ready manufacturing revenue decreased by 14% and 72 percentage points, respectively, compared to the same period in 2025, primarily due to lower unutilized manufacturing capacity costs, losses on firm purchase commitments and inventory write-downs, partially offset by higher sales volume.

In 2026, we anticipate that cost of sales will remain at a relatively consistent level compared to 2025, reflecting continued manufacturing productivity improvements and operational efficiencies. This expectation excludes the impact of the settlement with Arbutus and Genevant, for which we recorded a charge of $878 million in cost of sales in the first quarter of 2026 and expect additional amortization expense in the remainder of the year. Excluding this impact, to the extent net product sales increase, cost of sales as a percentage of net product sales and stand-ready revenue may decrease modestly.

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Research and development expenses

Research and development expenses decreased by $207 million, or 24%, for the three months ended March 31, 2026, compared to the same period in 2025. The decrease was mainly driven by a $48 million reduction in clinical manufacturing costs, driven by higher research and development funding from Blackstone for our seasonal flu program, a $48 million decrease in consulting and outside service costs, consistent with the lower level of clinical and manufacturing activities, and a $43 million reduction in personnel-related expenses due to lower headcount. Clinical trial expenses decreased by $42 million, reflecting lower activity in our seasonal flu, CMV, Norovirus, and RSV programs due to trial wind-downs, as well as the timing of clinical trial activities, partially offset by higher costs related to postmarketing commitments for our COVID products.

We anticipate a modest reduction in research and development expenses in 2026 compared to 2025, driven by continued portfolio prioritization, disciplined cost management, and a focused approach to pipeline execution. These reductions are expected to be partially offset by certain clinical trial activities shifting from 2025 into 2026 and additional costs related to post-marketing commitments. We remain committed to advancing our pipeline and late-stage programs, including intismeran autogene and norovirus vaccine programs, while continuing to manage research and development investment levels in line with our long-term objectives.

Selling, general and administrative expenses

For the three months ended March 31, 2026, selling, general and administrative expenses decreased by $39 million, or 18%, compared to the same period in 2025. The decrease was mainly driven by a $19 million decrease in personnel-related expenses, a $9 million decrease in marketing expenses, and an $8 million broad-based reduction in consulting and outside services. The decrease in the period largely reflects continued cost discipline and efforts to streamline operations.

We expect selling, general and administrative expenses in 2026 to remain at a level relatively consistent with 2025, reflecting an efficient and scalable operating structure. While we will continue to make selective investments to support our key priorities, including our global commercial and regulatory activities, we expect these investments to be largely offset by ongoing efficiency initiatives and disciplined resource allocation.

Interest income

For the three months ended March 31, 2026, interest income decreased by $18 million, or 20%, compared to the same period in 2025. The decrease was primarily due to lower average investment balances and interest rates.

Other expense, net

The following tables summarize other expense, net for the periods presented (in millions):

Three Months Ended March 31, Change 2026 vs. 2025

2026 2025 $ %

Loss on investments $ (1) $ (7) $ 6  (86)%

Interest expense (17) (1) (16) 1,600%

Other income, net

—  4  (4) (100)%

Total other expense, net

$ (18) $ (4) $ (14) 350%

For the three months ended March 31, 2026, total other expense, net increased by $14 million, or 350%, compared to the same period in 2025. The increase was largely driven by higher interest expense. Interest expense is primarily related to our finance leases related to certain contract manufacturing service agreements and, beginning in November 2025, interest associated with our long-term debt. Please refer to Note 10 and Note 11 to our condensed consolidated financial statements for additional information.

Income taxes

Provision for income taxes for the three months ended March 31, 2026, remained immaterial and consistent with the same periods in 2025. The effective tax rate continues to reflect the maintenance of our global valuation allowance, which limits our ability to recognize tax benefits from the losses. Please refer to Note 14 to our condensed consolidated financial statements for additional details.

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Liquidity and capital resources

The following table summarizes our cash, cash equivalents, investments and working capital as of March 31, 2026 and December 31, 2025 (in millions):

March 31, December 31,

2026 2025

Financial assets:

Cash and cash equivalents $ 1,908  $ 2,595

Investments 3,297  3,204

Investments, non-current 2,251  2,336

Total $ 7,456  $ 8,135

Working capital:

Current assets $ 5,770  $ 6,544

Current liabilities 2,395  1,987

Total $ 3,375  $ 4,557

Our cash, cash equivalents and investments are invested in accordance with our investment policy, primarily with a view to liquidity and capital preservation. Investments, consisting primarily of government and corporate debt securities, are stated at fair value. Cash, cash equivalents and investments as of March 31, 2026 decreased by $679 million, or 8%, compared to December 31, 2025. The decrease in cash, cash equivalents and investments was primarily due to a net cash outflow from operating activities of $630 million and purchases of property and equipment of $62 million during the three months ended March 31, 2026.

Working capital, defined as current assets less current liabilities, decreased by $1.2 billion, or 26%, as of March 31, 2026, compared to December 31, 2025. This was primarily driven by a decrease in cash, cash equivalents and current investments of $594 million to fund operations, an increase in accrued liabilities and accounts payable of $370 million, including $950 million related to the litigation settlement, partially offset by lower spend during the period, and a decrease in accounts receivable of $113 million primarily driven by timing of collections.

As of March 31, 2026, we did not have any off-balance sheet arrangements. For a discussion of our contractual obligations and commitments, refer to our 2025 Form 10-K.

Cash flow

The following table summarizes the primary sources and uses of cash for each period presented (in millions):

Three Months Ended March 31,

2026 2025

Net cash (used in) provided by:

Operating activities

$ (630) $ (1,037)

Investing activities

(76) 730

Financing activities

17  4

Operating activities

We derive cash flows from operations primarily from cash collected from customer advance payments and accounts receivable related to our product sales, as well as other revenue and funding arrangements. Our cash flows from operating activities are significantly affected by our use of cash for operating expenses and working capital to support the business. We sell our COVID and RSV vaccines to the commercial market as well as to foreign governments and international organizations. Certain supply agreements include upfront payments, which are initially recorded as deferred revenue. In the U.S., our COVID and RSV vaccines are sold primarily to wholesalers and distributors, and to a lesser extent, directly to retailers and healthcare providers. Wholesalers and distributors typically do not make upfront payments to us. In addition, we receive customer advance payments related to certain other revenue arrangements. As of March 31, 2026, we had $256 million in deferred revenue related to customer advance payments received or billable.

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Net cash used in operating activities for the three months ended March 31, 2026 was $630 million and consisted of net loss of $1.3 billion, non-cash adjustments of $160 million and a net change in assets and liabilities of $553 million. Non-cash items primarily included stock-based compensation of $104 million, and depreciation and amortization of $59 million. The net change in assets and liabilities was mainly due to an increase in accrued liabilities and accounts payable of $344 million, including $950 million related to the litigation settlement, partially offset by lower spend during the period, a decrease in accounts receivables, net of $114 million due to timing of collections, and a decrease in prepaid and other assets of $54 million, driven by a decrease in vendor prepayments.

Net cash used in operating activities decreased by $407 million, or 39%, during the three months ended March 31, 2026, compared to the same period in 2025, primarily attributable to a change in accrued liabilities and accounts payable of $881 million, including $950 million related to the litigation settlement. This decrease was partially offset by an increase in net loss of $372 million and a decrease in accounts receivable, net of $166 million, driven by timing of collections.

Investing activities

Our primary investing activities consist of purchases, sales, and maturities of our investments, capital expenditures for facilities, manufacturing and laboratory equipment, and computer equipment and software, as well as business development activities.

Net cash used in investing activities for the three months ended March 31, 2026 was $76 million, driven primarily by purchases of marketable securities of $1.3 billion, and purchases of property and equipment of $62 million, partially offset by proceeds from maturities and sales of marketable securities of $1.3 billion.

Net investing cash flows decreased by $806 million, or 110%, during the three months ended March 31, 2026, compared to the same period in 2025, primarily due to a decrease in proceeds from maturities and sales of marketable securities of $1.3 billion, partially offset by a decrease in purchases of marketable securities of $416 million, and a decrease in purchases of plant, property and equipment of $55 million.

Financing activities

Net cash provided by financing activities for the three months ended March 31, 2026 was $17 million, primarily related to proceeds from issuance of common stock through equity plans.

Net cash provided by financing activities increased by $13 million, or 325%, during the three months ended March 31, 2026, compared to the same period in 2025, mainly due to an increase in proceeds from issuance of common stock through equity plans of $16 million.

Operation and funding requirements

Our principal sources of funding as of March 31, 2026 consisted of cash and cash equivalents, investments, and cash we may generate from operations. We reported a net loss of $1.3 billion for the three months ended March 31, 2026 and net losses of $2.8 billion and $3.6 billion for the years 2025 and 2024, respectively. Historically, from our inception to the end of 2020, we incurred significant losses from operations due to our significant research and development expenses. Following the authorization of our first commercial product in December 2020, we generated significant net income in both 2022 and 2021. We have retained earnings of $5.9 billion as of March 31, 2026.

We have significant future capital requirements including expected operating expenses to conduct research and development activities, operate our organization, and meet capital expenditure needs. We anticipate maintaining substantial expenses across all areas of our ongoing activities, particularly as we continue research and development of our development candidates and clinical activities for our investigational medicines. This also extends to our manufacturing costs, including our arrangements with our supply and manufacturing partners. Our ongoing work on our intismeran autogene, norovirus, and flu+COVID combination vaccine candidates, our other oncology programs, development of any new COVID vaccines against variants of SARS-CoV-2, late-stage clinical development, investments in digital capabilities and artificial intelligence technologies, and buildout of global commercial, regulatory, sales and marketing infrastructure and manufacturing facilities will require significant cash outflows in future periods, most of which will not be reimbursed or otherwise paid for by our collaborators or alliances. We may also incur additional costs related to postmarketing commitments, though the timing and scope of such commitments remain uncertain. In addition, we have substantial facility, lease and purchase obligations. We have entered into various collaboration and licensing agreements, as well as research and development funding arrangements with third parties. These arrangements collectively encompass the funding of specific research and development activities, with the distinction that under the research and development funding arrangement, we receive funding. However, for all these arrangements, we may be obligated to make potential future milestone and royalty payments.

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In November 2025, we entered into a Credit and Guaranty Agreement (Credit Agreement) with lenders led by Ares Capital Corporation, as administrative agent, providing for a term loan facility with aggregate commitments of $1.5 billion. As of December 31, 2025, we had drawn $600 million under the initial term loan. The Credit Agreement also provides for $900 million of delayed draw term loan commitments, consisting of $400 million available, subject to applicable conditions, through November 2027 and $500 million available, subject to applicable conditions and specified regulatory approval milestones, through November 2028. Borrowings under the Credit Agreement bear interest at a variable rate based on Term SOFR or a base rate, at our option, plus an applicable margin, with interest payable periodically and the principal amount due in full at maturity in November 2030. The Credit Agreement includes customary affirmative and negative covenants, with which we were in compliance as of March 31, 2026. See Note 11 to our condensed consolidated financial statements for additional information.

We believe that our cash, cash equivalents, and investments as of March 31, 2026, together with cash expected to be generated from product sales and available borrowings under our credit facility, will be sufficient to enable us to fund our projected operations and capital expenditures through at least the next 12 months from the issuance of these financial statements included in this Form 10-Q. We are subject to all the risks related to the development and commercialization of novel medicines, and we may encounter unforeseen expenses, difficulties, complications, delays, and other unknown factors, which may adversely affect our business. For example, we experienced a decline in customer demand for our COVID vaccine in 2023 and 2024, and this trend continued in 2025 as the market transitions to a more competitive and commercially driven environment, with broader external factors continuing to affect market dynamics. We foresee that our commitment to investing in our business for future product launches may lead to continued negative cash flows from operations in upcoming periods. Our forecast of the period of time through which our financial resources will be adequate to support our operations is a forward-looking statement and involves risks and uncertainties, and actual results could vary as a result of a number of factors. We have based this estimate on assumptions that may prove to be wrong, and we could utilize our available capital resources sooner than we currently expect.

Critical accounting policies and significant judgments and estimates

There have been no material changes in our critical accounting policies and estimates in the preparation of our condensed consolidated financial statements during the three months ended March 31, 2026 compared to those disclosed in our 2025 Form 10-K.

Contractual Obligations

As of March 31, 2026, there have been no material changes to our contractual obligations and commitments from those described under “Management’s Discussion and Analysis of Financial Condition and Results of Operations” included in our 2025 Form 10-K.

Item 3. Quantitative and Qualitative Disclosures about Market Risk

Our market risks, and the way we manage them, are summarized in Part II, Item 7A., “Quantitative and Qualitative Disclosures About Market Risk” of our 2025 Form 10-K. There have been no material changes to our market risk or to our management of such risks for the three months ended March 31, 2026.

Item 4. Controls and Procedures

Disclosure Controls and Procedures

Our management, with the participation of our Chief Executive Officer and our Chief Financial Officer, evaluated the effectiveness of our disclosure controls and procedures as of March 31, 2026. The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act means controls and other procedures of a company that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the company’s management, including its principal executive and principal financial officers, as appropriate to allow timely decisions regarding required disclosure. Management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Based on the evaluation of our disclosure controls and procedures as of March 31, 2026, our Chief Executive Officer and Chief Financial Officer concluded that, as of such date, our disclosure controls and procedures were effective at the reasonable assurance level.

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Changes in Internal Control over Financial Reporting

There were no changes in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) during the three months ended March 31, 2026 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

Inherent Limitations on Effectiveness of Controls

Our management, including our Chief Executive Officer and Chief Financial Officer, believes that our disclosure controls and procedures and internal control over financial reporting are designed to provide reasonable assurance of achieving their objectives and are effective at the reasonable assurance level. However, our management does not expect that our disclosure controls and procedures or our internal control over financial reporting will prevent all errors and all fraud. A control system, no matter how well-conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, have been detected. These inherent limitations include the realities that judgments in decision making can be faulty, and that breakdowns can occur because of a simple error or mistake. Additionally, controls can be circumvented by the individual acts of some persons, by the collusion of two or more people or by a management override of the controls. The design of any system of controls also is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions; over time, controls may become inadequate because of changes in conditions, or the degree of compliance with policies or procedures may deteriorate. Because of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be detected.

PART II

Item 1. Legal Proceedings

We are involved in various claims and legal proceedings of a nature considered ordinary course in our business, including those described in our 2025 Form 10-K under the heading “Legal Proceedings.” Most of the issues raised by these claims are highly complex and subject to substantial uncertainties. For a description of risks relating to these and other legal proceedings we face, see Part I, Item 1A., “Risk Factors,” of our 2025 Form 10-K, including the discussion under the headings entitled “Risks related to our intellectual property” and “Risks related to the manufacturing of our commercial products and product candidates.” The outcome of any such proceedings, regardless of the merits, is inherently uncertain; therefore, assessing the likelihood of loss and any estimated damages is difficult and subject to considerable judgment.

Arbutus Patent Litigation

As more fully described in our 2025 Form 10-K, Arbutus Biopharma Corporation (Arbutus) and Genevant Sciences GmbH (Genevant) brought patent infringement actions against us in various jurisdictions, including in the U.S. District Court for the District of Delaware. On March 3, 2026, we entered into a settlement agreement with Arbutus and Genevant to resolve all patent infringement litigation pending worldwide. For more information, please see “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Settlement with Arbutus and Genevant.”

CureVac Patent Litigation

In April 2026, CureVac SE and CureVac Manufacturing GmbH filed a complaint against us in the U.S. District Court for the District of Delaware asserting that our manufacture and sale of Spikevax willfully infringes U.S. patents directed to RNA production methods and compositions with RNA encoding modified SARS-CoV-2 spike protein. The complaint seeks a judgment of infringement of the asserted patent and unspecified damages.

Item 1A. Risk Factors

Information regarding risk and uncertainties related to our business appears in Part I, Item 1A. “Risk Factors” of our 2025 Form 10-K. There have been no material changes from the risk factors previously disclosed in the 2025 Form 10-K.

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Item 2. Unregistered Sales of Equity Securities and Use of Proceeds

Issuer Purchases of Equity Securities

On August 1, 2022, our Board of Directors authorized a share repurchase program for our common stock of up to $3.0 billion, with no expiration date. During the three months ended March 31, 2026, there were no shares repurchased. As of March 31, 2026, $1.7 billion of our Board of Directors’ authorization for repurchases of our common stock remains outstanding, with no expiration date.

For details about our share repurchase programs, please refer to Note 12 to our consolidated financial statements, as set forth in our 2025 Form 10-K.

Item 5. Other Information

None of our directors or officers (as defined in Rule 16a-1(f) of the Securities Exchange Act of 1934, as amended) adopted or terminated a Rule 10b5-1 trading plan or arrangement or a non-Rule 10b5-1 trading plan or arrangement, as defined in Item 408(c) of Regulation S-K, during the fiscal quarter covered by this report.

Item 6. Exhibits

The Exhibits listed below are filed or incorporated by reference as part of this Form 10-Q.

Exhibit No. Exhibit Index

10.1*†#

Settle ment Agreement, d ated Marc h 3, 2026, by and between Arbutus Biopharma Corp. , Genevant Sciences GmbH , Genevant Sciences Ltd., Moderna, Inc. and Moderna TX, Inc.

31.1* Certification of Principal Executive Officer pursuant to Rule 13a-14(a) and Rule 15d-14(a) of the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

31.2* Certification of Principal Financial Officer pursuant to Rule 13a-14(a) and Rule 15d-14(a) of the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

32.1+ Certification pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

101.INS* XBRL Instance Document - The instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document

101.SCH* XBRL Taxonomy Extension Schema Document

101.CAL* XBRL Taxonomy Extension Calculation Document

101.DEF* XBRL Taxonomy Extension Definition Linkbase Document

101.LAB* XBRL Taxonomy Extension Label Linkbase Document

101.PRE* XBRL Taxonomy Extension Presentation Link Document

104* Cover Page Interactive Data File (formatted as Inline XBRL with applicable taxonomy extension information contained in Exhibits 101.)

* Filed herewith

+

The certification furnished in Exhibit 32.1 hereto is deemed to accompany this Form 10-Q and will not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended. Such certification will not be deemed to be incorporated by reference into any filings under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, except to the extent that the Registrant specifically incorporates it by reference.

Certain portions of this exhibit (indicated by [***]) have been omitted pursuant to Item 601(b)(10)(iv) of Regulation S-K.

#

Annexes, schedules and/or exhibits have been omitted pursuant to Item 601(a)(5) of Regulation S-K. The Company undertakes to furnish supplemental copies of any of the omitted schedules or similar attachments upon request by the SEC.

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SIGNATURES

Pursuant to the requirements of the Section 13 or 15(d) of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

MODERNA, INC.

Date: By: /s/ Stéphane Bancel

May 1, 2026

Stéphane Bancel

Chief Executive Officer and Director

( Principal Executive Officer)

Date: By: /s/ James M. Mock

May 1, 2026

James M. Mock

Chief Financial Officer

( Principal Financial Officer)

40

打开原文

莫德纳三层管线布局

重要性3/5 中

公司一手材料直接覆盖MRNA管线、潜在上市和现金目标,但以战略展望为主,缺乏新结果与独立验证。

中文摘要

核心结论

莫德纳(Moderna,MRNA)在科学日材料中把增长路径分为已商业化和后期项目、临床概念验证项目、即将进入临床的新技术三层,并把2026年后期数据、2027—2028年疫苗上市预期及2028年现金盈亏平衡列为关键节点。材料属于公司首席执行官的战略叙事,临床、上市和财务目标均含前瞻性假设。

重要性评级

评级:3/5(中)。文章直接涉及MRNA的产品组合、研发进度与现金盈亏平衡目标,且信息来自公司一把手;但发布日期距07/11已有一段时间,未提供新临床结果或财务实绩。

关键事实

  • 正文标注为06/25发布,元数据标注06/11(未给出具体时刻),两处日期不一致。
  • 公司称传染病疫苗已有4款获批产品,预计在2027—2028年最多推出3款新产品:流感与新冠联苗、季节性流感疫苗及诺如病毒疫苗。
  • 2026年预期出现个体化新抗原疗法intismeran autogene及丙酸血症疗法的关键性数据读出;公司称这些数据可能支持其首个肿瘤和罕见病产品上市。
  • 处于第二层的mRNA-2808为多发性骨髓瘤项目,处在Phase 1/2(一期/二期临床),公司称其为首个在单一药物中整合3个靶点的多重T细胞衔接剂;卵巢癌候选药mRNA-2151仍在临床前阶段。
  • 第三层的mRNA-6007拟用于系统性红斑狼疮,采用体内CAR-T(嵌合抗原受体T细胞)思路和靶向脂质纳米颗粒递送,目标是实现深度B细胞清除及短暂CAR表达。
  • 公司提出以数据、人工智能、机器学习、自动化和机器人构建“科学智能引擎”,并计划以已上市产品和预期疫苗上市带来的现金支持后续研发。
  • 管理层称公司目标是在2028年实现现金盈亏平衡,并把2026年定义为销售增长、后期临床数据和新技术推进的重要年份。

作者观点与证据

首席执行官将莫德纳描述为可重复产出药物的平台型生物技术公司,主张三层项目可形成持续增长循环。可核验事实包括已获批产品数量、候选药名称、研发阶段和目标时间表;“早期临床信号令人鼓舞”、平台壁垒、未来上市与现金盈亏平衡均为公司预期。文末明确提示实际结果可能因研发、监管、商业化及其他风险而与陈述存在重大差异。

与相关标的的关系

MRNA的直接关联较强:材料覆盖其传染病疫苗收入延展、肿瘤与罕见病后期数据,以及自身免疫领域的早期技术。2026年数据读出和2027—2028年潜在产品上市是公司所列的验证节点,尚未构成已实现收入或获批事实。

时效性与限制

截至07/11,材料为6月的公司科学日战略更新,适合用作管线框架和管理层目标的背景资料。原文缺少具体披露时刻,且正文与元数据日期不一致;未给出试验详细数据、监管结论、销售金额或独立第三方评估,来源也带有公司宣传和前瞻性陈述属性。

后续跟踪

  • intismeran autogene和丙酸血症项目在2026年的关键性数据及完整试验设计。
  • 流感、新冠联苗和诺如病毒疫苗的监管进展与实际上市时间。
  • mRNA-2808及mRNA-6007的安全性、有效性和临床推进情况。
  • 现金盈亏平衡目标对应的销售、成本和研发投入披露。
原文
Moderna Science Day 2026

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/ Building Moderna's Next Decade of Grow... 25 June 2026

Building Moderna's Next Decade of Growth: Executing on Our Commercial Opportunities Today While Inventing New Modalities for Tomorrow

Stéphane Bancel, CEO of Moderna

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A question I hear frequently from investors is: What does Moderna look like in 10 years?

The answer begins with a simple idea that has guided our company from the beginning. We are building a platform capable of repeatedly creating new medicines. Over the last decade, we have transformed mRNA from a scientific concept into approved medicines used around the world. Now, we are entering the next chapter of that journey.

At our 2026 Science Day event today, we shared how we think about Moderna's future through three horizons. Together, these horizons represent a balanced strategy designed to deliver near-term growth, expand our impact for patients and create long-term value.

Importantly, the horizons framework is also how we think about building a durable biotechnology company. It provides a disciplined approach to allocating capital, managing risk and translating platform innovation into future growth opportunities.

Horizon 1 focuses on established modalities that are already driving commercialization and late-stage development. Horizons 2 and 3, led by Moderna Research and Early Development (mRED), focus on expanding our platform into emerging and future modalities that have the potential to become the next generation of growth drivers.

Working across three horizons, we are applying our mRNA platform expertise to validate, scale and expand our modalities. At the same time, we are driving innovation by harnessing data, AI and machine learning, and robotics to accelerate discovery and continuously improve how we deliver the next generation of mRNA medicines for patients around the world.

A Platform Built for Repeatable Innovation

Our platform is built on three integrated pillars: mRNA science, delivery science and advanced manufacturing processes. By combining these capabilities, we create modalities—groups of potential medicines that share similar mRNA technologies, delivery technologies and manufacturing processes to achieve common product characteristics.

As modalities advance, sentinel programs generate proof-of-concept data that help validate the underlying science, de-risk development and accelerate future programs. This creates a repeatable model for innovation that allows us to apply lessons learned across multiple medicines and disease areas.

Horizon 1: Scaling Proven Modalities

The first horizon consists of the modalities we have already established through clinical development and commercialization. Horizon 1 includes three modalities: infectious disease vaccines, intismeran autogene, and rare disease therapeutics. These programs represent years of scientific investment and are now moving into a period defined by execution as we broaden our portfolio, expand our geographic reach, and build multiple sustainable growth engines powered by our mRNA platform.

Building on strong momentum in our infectious disease vaccine business with four approved products, we are anticipating the potential launch of up to three new products in 2027 and 2028, including flu plus COVID combination, seasonal flu and norovirus vaccines. At the same time, we expect important clinical milestones this year, including potential pivotal data readouts for our investigational individualized neoantigen therapy (intismeran autogene) and rare genetic disease propionic acidemia therapeutic, which could support the possible launch of our first oncology and rare disease products.

As our business evolves to support our three franchises, multiple potential product launches and important late-stage clinical milestones, our operating model must evolve as well. Recently, we announced an expansion of Stephen Hoge's role as President and welcomed Ester Banque to Moderna as our new Chief Commercial Officer. These leadership changes reflect the next phase of our growth strategy.

Horizon 2: Advancing New Modalities in the Clinic to Establish Human Proof-of-Concept

Horizon 2 is focused on extending the reach of our platform into new areas where we believe mRNA can create meaningful advances for patients. Emerging oncology is one of the most important examples.

Our oncology strategy is increasingly focused on intervening earlier in the cancer journey—not only treating advanced disease, but potentially reducing recurrence after surgery and one day helping prevent certain cancers before they develop. We are currently exploring opportunities across solid tumors, metastatic disease and hematologic cancers.

Our goal in Horizon 2 is to advance high-potential programs toward clinical proof-of-concept, creating new modalities that can eventually become future growth pillars for Moderna. One example is our T-cell engager modality. Our sentinel program, mRNA-2808 for multiple myeloma, is currently in Phase 1/2 development and is the first multiplex T-cell engager in the clinic to combine three targets in a single medicine. Based on an encouraging early clinical signal with mRNA-2808, we are advancing mRNA-2151, a preclinical T-cell engager program for ovarian cancer, toward early clinical development.

Horizon 3: Preparing New Modalities to Enter the Clinic

Horizon 3 includes the modalities and technologies that have the potential to become the next wave of innovation for Moderna. Scientific innovation has always required long-term thinking and the medicines that drive growth ten years from now are often the research programs being conceived today.

The purpose of Horizon 3 is not simply to create more programs. It is to create entirely new categories of medicines that can expand the reach of our platform and address diseases that currently have limited treatment options. These Horizon 3 modalities are gearing up to be in the clinic soon.

An example is our in vivo CAR-T modality. Our investigational mRNA-6007 program is designed to enable deep B-cell depletion for autoimmune conditions using a multiplexed mRNA approach with targeted lipid nanoparticles. The program aims to deliver mRNA into immune cells in vivo , enabling transient CAR expression and potential immune reset, with the initial clinical focus in systemic lupus erythematosus (SLE). Beyond this first indication, we see the potential to apply the underlying technology across multiple autoimmune diseases. We are also exploring follow-on concepts that leverage the same delivery technology and could extend into oncology applications.

The Engine Connecting All Three Horizons

There is another element that connects these horizons together: data. Across Moderna, we are building what we call our Scientific Intelligence Engine—a system that combines data, AI and machine learning, automation, and robotics to accelerate discovery and improve how we work. Every experiment, every manufacturing run, and every clinical study contributes to a growing body of knowledge that can inform future medicines.

The faster we learn, the more we can expand our leadership in mRNA medicines and improve our moat. Given the scale of preclinical and clinical data we have, this is a unique advantage in a world where learning the fastest is key to long-term success.

The result is a virtuous cycle. Data generated in Horizon 1 helps advance Horizons 2 and 3. Discoveries from Horizons 2 and 3 ultimately graduate to become the next generation of Horizon 1 opportunities. This ability to learn across programs, modalities and therapeutic areas is one of the defining strengths of our platform.

Looking Ahead

When I look at Moderna today, I see a company that is executing on near-term opportunities while continuing to invest in long-term innovation. We are building a large infectious disease vaccine franchise focused on protecting at-risk populations and driving our path to cash breakeven by 2028. We expect to reinvest cash generated from our marketed products as well as anticipated launches of influenza, flu plus COVID combination and norovirus vaccines, into the next phases of growth for Moderna.

Those investments are helping advance our late-stage oncology and rare disease programs, which we believe can become important growth drivers in 2027 and 2028. At the same time, we are continuing to invest in our early-stage pipeline, with the goal of creating future modalities and franchises that can contribute to growth in 2029 and beyond.

I have never been as excited about Moderna’s future as I am now. 2026 is going to be a pivotal year for Moderna: sales growth, new late-stage clinical data, new modalities to fuel growth of many medicines, and investing in basic science and AI to keep learning and expanding what we can do to help patients for decades to come.

Forward-Looking Statements

This post and accompanying video contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding: the potential of Moderna’s mRNA platform and promise as a multi-modality biotechnology company; anticipated 2026 sales growth and future growth; Moderna’s potential three commercial franchises; Moderna’s path to cash breakeven by 2028; Moderna’s Scientific Intelligence Engine; anticipated infectious disease launches in 2027 and 2028; anticipated geographic expansion; potential pivotal data readouts in 2026 for intismeran and propionic acidemia, which could support possible launches; growth drivers in 2027 and 2028; Moderna’s emerging oncology programs; the potential to reduce recurrence after surgery and prevent certain cancers before they develop; the encouraging early clinical signal with mRNA-2808; Moderna’s ongoing and planned clinical studies; and anticipated progress and milestones for Moderna’s programs, including anticipated timing. In some cases, forward-looking statements can be identified by terminology such as "will," "may," "should," "could," "expects," "intends," "plans," "aims," "anticipates," "believes," "estimates," "predicts," "potential," "continue," or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. The forward-looking statements in this post are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna's control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include, among others, those risks and uncertainties described under the heading "Risk Factors" in Moderna's Annual Report on Form 10-K for the fiscal year ended December 31, 2025, filed with the U.S. Securities and Exchange Commission (SEC), and in subsequent filings made by Moderna with the SEC, which are available on the SEC's website at www.sec.gov. Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this post in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna's current expectations and speak only as of the date of this post.

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莫德纳流感疫苗审议安排

重要性2/5 中低

FDA一手程序信息与MRNA直接相关,但会议已结束且原文未含投票、审批或临床结论。

中文摘要

核心结论

FDA(美国食品药品监督管理局)于06/18召开疫苗及相关生物制品咨询委员会会议,讨论莫德纳(MRNA)mFlusiva(mRNA-1010流感疫苗)面向50岁及以上人群预防甲型和乙型流感的生物制品许可申请。该页面只公告会议安排和材料,未披露委员会投票、FDA最终决定或产品获批结果。

重要性评级

评级:2/5(中低)。来源为FDA官方页面,且监管事项直接关联MRNA;不过会议已在06/18举行,截至07/11页面仍只是会前安排,缺少结果信息,日报增量有限。

关键事实

  • 会议日期为06/18(未给出具体时刻),公开会议时段为美东时间 06/18 08:30(UTC+8 06/18 20:30)至美东时间 06/18 16:00(UTC+8 06/19 04:00)。
  • 审议对象为莫德纳TX公司生产的mFlusiva,即mRNA-1010流感疫苗;申请编号为STN 125869/0。
  • 申请适用人群为50岁及以上,拟预防疫苗所涵盖的甲型和乙型流感病毒亚型引起的流感疾病。
  • 咨询委员会向FDA提供独立专家建议,建议不具法律约束力,FDA通常会参考但不必采纳。
  • 公众口头发言安排在美东时间 06/18 13:00(UTC+8 06/19 01:00)至美东时间 06/18 14:00(UTC+8 06/19 02:00)之间;案卷号为FDA-2026-N-4162。
  • 公共意见截止于06/17;电子提交系统截止为美东时间 06/17 23:59(UTC+8 06/18 11:59)。
  • 页面列有FDA和莫德纳的简报、勘误、投票问题及mRNA-1010安全性、免疫原性和有效性审查材料,但正文未摘录这些材料的实质结论。

作者观点与证据

页面为监管机构的程序性公告,没有提出产品有效性或安全性的正负判断。可确认的证据是会议议程、申请产品、目标人群、案卷和公开材料清单;产品是否获批、委员会如何表决及监管机构是否采纳建议均不能从本文推出。

与相关标的的关系

MRNA直接相关,因为mFlusiva是莫德纳拟扩大流感疫苗组合的候选产品,咨询委员会审议属于许可流程节点。页面没有给出临床数据细节或审议结果,无法据此判断该产品的监管概率、上市时间或收入影响。

时效性与限制

公告发布于06/16(未给出具体时刻),会议已于06/18举行,截至07/11属于已过期的会前信息。FDA为高质量一手来源,但本文仅覆盖程序安排;后续引用需要补充会议记录、投票结果、FDA行动日期及正式标签或批准文件。

后续跟踪

  • 咨询委员会投票问题、投票结果和会议纪要。
  • FDA对STN 125869/0的正式行动及日期。
  • mFlusiva的获批标签、适用年龄和安全性说明。
  • FDA与莫德纳公开简报中关于有效性、免疫原性和安全性的具体数据。
原文
Vaccines and Related Biological Products Advisory Committee June 18, 2026 Meeting Announcement
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Vaccines and Related Biological Products Advisory Committee June 18, 2026 Meeting Announcement - 06/18/2026

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Advisory Committee Calendar

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Date:

June 18, 2026

Time:

8:30 a.m.

  • 4:00 p.m.

ET

What is an advisory committee?

Advisory committees provide independent expert advice to the FDA on broad scientific topics or on certain products to help the agency make sound decisions based on the available science. Advisory committees make non-binding recommendations to the FDA, which generally follows the recommendations but is not legally bound to do so. Please see, " Advisory Committees Give FDA Critical Advice and the Public a Voice ," for more information.

Please note that all meeting participants will be joining this advisory committee meeting through an online teleconferencing and/or video conferencing platform.

How to Attend

  • 06/18/2026
  • https://youtube.com/live/9W18lwG7vD8

CBER plans to provide a free of charge live webcast of the Vaccines and Related Biological Products Advisory Committee Meeting. If there are instances where the webcast transmission is not successful, staff will work to re-establish the transmission as soon as possible.

Agenda

The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing and/or video conferencing platform. On June 18, 2026, the Committee will meet in open session to discuss and make recommendations on the safety and effectiveness of MFLUSIVA (Influenza Vaccine, mRNA), manufactured by Moderna TX Inc., with a requested indication in Biologics License Application STN 125869/0 for the prevention of influenza disease caused by influenza virus subtypes A and type B represented in the vaccine, in persons 50 years of age and older.

Meeting Materials

FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its website prior to the meeting, the background material will be made publicly available at the time of the advisory committee meeting, and the background material will be posted on FDA’s website after the meeting. Background material is available at the Advisory Committee Calendar . Scroll down to the appropriate advisory committee meeting link. The meeting will include slide presentations with audio components to allow the presentation of materials in a manner that most closely resembles an in-person advisory committee meeting.

Public Participation Information

Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee.

Oral presentations from the public will be scheduled between approximately 1:00 p.m. and 2:00 p.m. Eastern Time on June 18, 2026.

FDA is establishing a docket for public comment on this meeting.

The docket number is FDA-2026-N-4162.

The docket will close on June17, 2026. Submit either electronic or written comments on this public meeting on or before June 17, 2026. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before June 17, 2026. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of June 17, 2026. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are received on or before that date.

Comments received on or before June 12, 2026, will be provided to the committee. Comments received after that date and on June 17, 2026, will be taken into consideration by FDA. In the event that the meeting is canceled, FDA will continue to evaluate any relevant applications or information, and consider any comments submitted to the docket, as appropriate.

You may submit comments as follows:

Electronic Submissions

Submit electronic comments as follows:

  • Federal eRulemaking Portal: https://www.regulations.gov . Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov .
  • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

Written/Paper Submissions

Submit written/paper submissions as follows:

  • Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
  • For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

Instructions: All submissions received must include the Docket No. FDA-2026-N-4162 for “Vaccines and Related Biological Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments – Safety and Effectiveness of MFLUSIVA (Influenza Vaccine, mRNA) manufactured by Moderna TX Inc.”. Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.

Confidential Submissions: To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” FDA will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov . Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify the information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf .

Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500.

FOR FURTHER INFORMATION, CONTACT: Cicely Reese; Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 3215, Silver Spring, MD 20993-0002, 301-796-9025, email: CBERVRBPAC@fda.hhs.gov, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area).

Oral Presentations

Oral presentations from the public will be scheduled between approximately 1:00 p.m. and 2:00 p.m. Eastern Time on June 18, 2026.

Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before 12 p.m. Eastern Time on June 8, 2026.

Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by 6 p.m. Eastern Time on June 10, 2026.

Webcast Information

CBER plans to provide a free of charge live webcast of the Vaccines and Related Biological Products Advisory Committee meeting:

The online web conference meeting will be available at the following link:

  • 06/18/2026
  • https://youtube.com/live/9W18lwG7vD8

If there are instances where the webcast transmission is not successful, staff will work to re-establish the transmission as soon as possible.

Contact Information

  • Cicely Reese: CBERVRBPAC@fda.hhs.gov
  • FDA Advisory Committee Information Line:

1-800-741-8138 (301-443-0572 in the Washington, DC area). Please call the Information Line for up-to-date information on this meeting.

  • For press inquiries, please contact the HHS Press Room at www.hhs.gov/press-room/index.html or 202-690-6343.

Official FR Notice

A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the agency’s website or call the committee’s Designated Federal Officer (see Contact Information) to learn about possible modifications before coming to the meeting.

Persons attending FDA’s advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact the committee’s Designated Federal Officer (see Contact Information) at least 7 days in advance of the meeting.

Answers to commonly asked questions including information regarding special accommodations due to a disability may be accessed at: Common Questions and Answers about FDA Advisory Committee Meetings .

FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at Public Conduct During FDA Advisory Committee Meetings for procedures on public conduct during advisory committee meetings.

Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app.2).

Event Materials

Title

File Type/Size

Source Organization

Vaccines and Related Biological Products Advisory Committee June 18, 2026 Meeting Waivers for Conflicts of Interest

pdf (99.25 KB)

FDA

Vaccines and Related Biological Products Advisory Committee June 18, 2026 Meeting Briefing Document- FDA

pdf (1.04 MB)

FDA

Vaccines and Related Biological Products Advisory Committee June 18, 2026 Meeting Briefing Document- Moderna

pdf (1.05 MB)

Non-FDA

Vaccines and Related Biological Products Advisory Committee June 18, 2026 Meeting Briefing Document- Moderna- Errata

pdf (312.89 KB)

Non-FDA

Vaccines and Related Biological Products Advisory Committee June 18, 2026 Meeting Draft Agenda

pdf (161.94 KB)

FDA

Vaccines and Related Biological Products Advisory Committee June 18, 2026 Meeting Voting Questions

pdf (98.13 KB)

FDA

Vaccines and Related Biological Products Advisory Committee June 18, 2026 Meeting Draft Roster

pdf (187.44 KB)

FDA

Vaccines and Related Biological Products Advisory Committee June 18, 2026 Meeting Presentation- Biologics License Application for STN 125869-0- FDA

pdf (600.17 KB)

FDA

Vaccines and Related Biological Products Advisory Committee June 18, 2026 Meeting Presentation- Introduction- FDA

pdf (601.31 KB)

FDA

Vaccines and Related Biological Products Advisory Committee June 18, 2026 Meeting Presentation- Investigational Influenza Vaccine mRNA-1010 in Adults 50 Years- Moderna

pdf (2.01 MB)

Non-FDA

Vaccines and Related Biological Products Advisory Committee June 18, 2026 Meeting Presentation- Seasonal Influenza Vaccines- Current Status and Opportunities for Improved Effectiveness- External

pdf (1.25 MB)

Non-FDA

Vaccines and Related Biological Products Advisory Committee June 18, 2026 Meeting Presentation- U.S. Influenza Surveillance and Preliminary End-of-Season Influenza Vaccine Effectiveness Estimates, 2025-26- CDC

pdf (2.18 MB)

Non-FDA

Vaccines and Related Biological Products Advisory Committee June 18, 2026 Meeting Presentation- Review of Efficacy, Immunogenicity, and Safety of mFlusiva (mRNA-1010)- FDA

pdf (3.65 MB)

FDA

Vaccines and Related Biological Products Advisory Committee June 18, 2026 Meeting Final Roster

pdf (186.88 KB)

FDA

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打开原文

个体化癌症疫苗五年随访

重要性4/5 中高

官方长期随机二期临床数据直接涉及MRK与MRNA的肿瘤管线,疗效数字和后续试验进度具备较高信息密度;发布时间已有一个多月,且总生存期与确证性证据仍有限。

中文摘要

核心结论

默沙东(MRK)与莫德纳(MRNA)公布的二期临床五年随访显示,个体化新抗原疗法 intismeran autogene 联合 KEYTRUDA(帕博利珠单抗)较 KEYTRUDA 单药,降低高风险Ⅲ/Ⅳ期黑色素瘤术后复发或死亡风险及远处转移或死亡风险。结果为两家公司肿瘤管线提供长期疗效证据,但仍未构成确证性三期临床结果。

重要性评级

评级:4/5(中高)。这是两家相关公司在肿瘤业务上的官方长期临床更新,包含明确的疗效、安全性和后续试验进度;发布于06/01,至07/11已超过一个月,且试验样本与总生存期数据限制了即时解读力度。

关键事实

  • 美东时间 06/01 08:00(UTC+8 06/01 20:00),默沙东和莫德纳发布 KEYNOTE-942/mRNA-4157-P201 随机、开放标签二期临床的计划五年随访结果,并在2026年美国临床肿瘤学会年会上披露。
  • 研究纳入157名完成切除、复发风险较高的Ⅲ/Ⅳ期黑色素瘤患者,按2:1分配至联合治疗或 KEYTRUDA 单药;中位随访60.3个月,范围50.5至76.4个月。
  • 联合组无复发生存期较单药组改善:复发或死亡风险降低49%,风险比为0.51,95%置信区间为0.294至0.887。
  • 联合组远处转移无生存期改善:远处转移或死亡风险降低59%,风险比为0.411,95%置信区间为0.200至0.843。
  • 探索性总生存期结果的风险比为0.471、95%置信区间为0.165至1.345,事件数仅14例,区间跨越1。
  • 联合治疗最常见归因不良事件为疲劳、注射部位疼痛和寒战,发生率各为59.6%、59.6%和51.0%;最常见三级事件为疲劳4.8%,未报告四级或五级归因事件。
  • 两家公司称共有9项二期或三期项目在多种肿瘤中推进;辅助黑色素瘤三期试验 INTerpath-001 和辅助肾癌二期试验已完成入组,若干非小细胞肺癌、膀胱癌和转移性黑色素瘤试验仍在入组。

作者观点与证据

文章由默沙东和莫德纳联合发布,立场强调疗效持续性、免疫机制支持及个体化疗法在辅助治疗中的潜力。无复发生存期和远处转移无生存期的风险比及置信区间来自随机二期试验,证据较具体;总生存期仅为探索性分析,样本事件数少且置信区间跨越1。安全性和管线描述同样来自公司披露,尚需确证性试验、监管审评和同行独立核验。

与相关标的的关系

  • MRK:KEYTRUDA 是默沙东肿瘤业务的重要产品;该组合方案的长期数据关系到其在术后辅助治疗领域的延展和联合疗法布局。
  • MRNA:intismeran autogene 是莫德纳个体化癌症疫苗平台的重要临床资产;五年结果及多项后续试验进度直接关联该平台的临床验证路径。

时效性与限制

文章发布于美东时间 06/01 08:00(UTC+8 06/01 20:00),检索于美东时间 07/11 10:26(UTC+8 07/11 22:26)。这是公司联合新闻稿,并同步称在学术会议和期刊发布;原始归档文本未附独立审稿内容或完整统计表。试验为157人的二期研究,跨适应症的商业化前景仍取决于三期结果、监管审批、生产交付和竞争产品进展。

后续跟踪

  • INTerpath-001 三期辅助黑色素瘤试验的疗效、安全性和披露时间。
  • 总生存期事件数增加后的更新及置信区间变化。
  • 非小细胞肺癌、肾癌和膀胱癌项目的入组完成、读出与监管沟通。
  • 个体化疗法的生产周期、可及性及真实世界安全性信息。
原文
Moderna and Merck Present 5-Year Data for Intismeran Autogene in Combination With KEYTRUDA

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Moderna and Merck Present 5-Year Data for Intismeran Autogene in Combination With KEYTRUDA&reg; (pembrolizumab) in Patients With High-Risk Stage III/IV Melanoma Following Complete Resection at the 2026 ASCO Annual Meeting

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June 1, 2026 8:00 am EDT

At a median 5-year (60.3 months) planned follow-up of the Phase 2b KEYNOTE-942/mRNA-4157-P201 study, intismeran autogene in combination with KEYTRUDA demonstrated a 49% reduction in the risk of recurrence or death and a 59% reduction in the risk of distant metastasis or death compared to KEYTRUDA alone

Intismeran autogene in combination with KEYTRUDA demonstrated an encouraging trend toward overall survival in an exploratory analysis compared to KEYTRUDA alone (HR=0.471; [95% CI, 0.165–1.345])

CAMBRIDGE, MA and RAHWAY, N.J. / Access Newswire / June 1, 2026 / Moderna, Inc. (NASDAQ: MRNA) and Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced detailed results from a planned five-year follow-up analysis of the Phase 2b randomized KEYNOTE-942/mRNA-4157-P201 study evaluating intismeran autogene (mRNA-4157 or V940), an investigational mRNA-based individualized neoantigen therapy (INT), in combination with KEYTRUDA ® (pembrolizumab), Merck’s anti-PD-1 therapy, in patients with high-risk melanoma (stage III/IV) following complete resection. These data will be presented today at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting (May 29-June 2) and published simultaneously in ASCO’s Journal of Clinical Oncology .

With a median follow-up of 60.3 months (range, 50.5-76.4), adjuvant treatment with intismeran autogene in combination with KEYTRUDA continued to prolong recurrence-free survival (RFS), the study’s primary endpoint, reducing the risk of recurrence or death by 49% (HR=0.51; [95% CI, 0.294-0.887]) compared to KEYTRUDA alone. Intismeran autogene in combination with KEYTRUDA also continued to demonstrate a meaningful improvement in distant metastasis-free survival (DMFS), a key secondary endpoint of the study, reducing the risk of distant metastasis or death by 59% (HR=0.411; [95% CI, 0.200–0.843]) compared to KEYTRUDA alone. The exploratory endpoint of overall survival (OS) also demonstrated an encouraging trend toward improved OS (HR=0.471; [95% CI, 0.165–1.345]; n=14) with intismeran autogene in combination with KEYTRUDA compared to KEYTRUDA alone. Together, these findings indicate a sustained improvement in RFS and DMFS at five years.

“With each year of continued follow-up of our Phase 2b study, we gain a more complete picture of the durability of intismeran autogene in combination with KEYTRUDA. Now, with a median follow-up of five years, the sustained recurrence-free survival and distant metastasis-free survival demonstrate the potential long-term benefit of intismeran autogene in combination with KEYTRUDA in melanoma patients at high risk of recurrence,” said David Berman, M.D., Ph.D., Chief Development Officer of Moderna. “These findings add to our confidence in the potentially transformative impact of this novel, personalized approach to cancer care made possible by mRNA technology.”

“The risk of disease recurrence remains high for patients with stage III/IV melanoma following surgery, so we are encouraged by these long-term findings showing that intismeran autogene in combination with KEYTRUDA provided sustained and durable reductions in the risk of recurrence,” said Dr. Majorie Green, Senior Vice President and Head of Oncology, Global Clinical Development, Merck Research Laboratories. “These data further reinforce the potential of this individualized approach to address critical gaps in the adjuvant setting and reflect our continued commitment to advancing innovative therapies for patients.”

The safety profile of intismeran autogene in combination with KEYTRUDA remained consistent with prior analyses. The most common adverse events attributed to intismeran autogene in combination with KEYTRUDA were fatigue (59.6%), injection site pain (59.6%), and chills (51.0%). The majority of the adverse events attributed to intismeran autogene were Grade 1 (31.7%) and Grade 2 (51.9%), with fatigue being the most common Grade 3 event (4.8%) and no Grade 4-5 events. Immune-related adverse events occurred in 45.2% of patients receiving the combination and 44% receiving KEYTRUDA alone. Intismeran autogene in combination with KEYTRUDA did not result in potentiation of immune-related AEs.

The findings build on the primary analysis and supportive analysis at an approximately three-year follow-up (34.9 months), presented at the 2024 ASCO Annual Meeting , in which intismeran autogene in combination with KEYTRUDA resulted in a 49% RFS risk reduction and 62% DMFS risk reduction compared to KEYTRUDA alone.

Additional subgroup and translational data

Data from an exploratory subgroup analysis continued to indicate that improvement in RFS was maintained with intismeran autogene in combination with KEYTRUDA across subpopulations, including age, sex, disease state (Stage III/IV), programmed death-ligand 1 (PD-L1) status, BRAF status, tumor mutation burden (TMB) or circulating tumor DNA (ctDNA) status, compared to KEYTRUDA alone.

Intismeran autogene plus KEYTRUDA increased T-cell clonal expansion and promoted the emergence of new T-cell clonotypes compared with KEYTRUDA alone. At long-term follow-up, patients receiving the combination demonstrated an approximately two-fold higher proportion of novel expanded T-cell clonotypes versus KEYTRUDA monotherapy (0.030 vs 0.016 median summed frequency). Higher magnitude increases of these novel T-cell clones was associated with remaining recurrence-free; recurrence-free patients in the combination arm had approximately twice the number of unique novel expanded clonotypes at long-term follow-up (median number 42 vs. 20 in recurrence-free vs recurrence patients, respectively). Additional data presented at ASCO (abstract #9564) found that, in a subset of patients receiving adjuvant combination therapy, these novel clonotypes were linked to intismeran-encoded neoantigens, supporting intismeran’s proposed mechanism of action and association with clinical benefit.

Ongoing clinical development programs

Moderna and Merck have nine total Phase 2 and Phase 3 clinical trials underway investigating intismeran autogene in combination with KEYTRUDA across multiple tumor types, including melanoma, non-small cell lung cancer (NSCLC), bladder cancer and renal cell carcinoma. This includes the recent initiation of a Phase 3 study of intismeran autogene as a monotherapy and in combination with KEYTRUDA for the treatment of high-risk Stage I NSCLC (INTerpath-014, NCT07513376 ).

The Phase 3 clinical trial for adjuvant melanoma (INTerpath-001, NCT05933577 ) and a randomized Phase 2 study for adjuvant renal cell carcinoma (INTerpath-004, NCT06307431 ) are fully enrolled. Two NSCLC Phase 3 studies, evaluating adjuvant treatment in patients with completely resected NSCLC (INTerpath-002, NCT06077760 ) and evaluating adjuvant treatment for patients with resectable NSCLC after receiving neoadjuvant KEYTRUDA plus platinum-based chemotherapy (INTerpath-009, NCT06623422 ), are enrolling. Randomized Phase 2 studies for patients with resected muscle invasive bladder cancer (INTerpath-005, NCT06305767 ) and resected non-muscle invasive bladder cancer (INTerpath-011, NCT06833073 ) are enrolling, a Phase 2 study of first-line treatment for patients with metastatic melanoma (INTerpath-012, NCT06961006 ) and a Phase 2 study of first-line treatment for patients with metastatic squamous NSCLC (INTerpath-013, NCT07221474 ) are also enrolling.

About intismeran autogene (mRNA-4157 or V940)

Intismeran autogene is a novel investigational messenger RNA (mRNA)-based individualized neoantigen therapy (INT) consisting of a synthetic mRNA coding for up to 34 neoantigens that is designed and produced based on the unique mutational signature of the DNA sequence of the patient’s tumor. Upon administration into the body, the algorithmically derived and RNA-encoded neoantigen sequences are endogenously translated and undergo natural cellular antigen processing and presentation, a key step in adaptive immunity. Individualized neoantigen therapies are designed to train and activate an antitumor immune response by generating specific T-cell responses based on the unique mutational signature of a patient’s tumor.

About KEYNOTE-942/mRNA-4157-P201 ( NCT03897881 )

KEYNOTE-942 is an ongoing randomized, open-label Phase 2b trial that enrolled 157 patients with high-risk stage III/IV melanoma. Following complete surgical resection, patients were assigned 2:1 (stratified by stage) to receive intismeran autogene (1 mg every three weeks for nine doses) and KEYTRUDA (200 mg every three weeks up to 18 cycles [for approximately one year]) versus KEYTRUDA alone for approximately one year until disease recurrence or unacceptable toxicity. The primary endpoint is RFS, defined as the time from first dose of KEYTRUDA until the date of first recurrence (local, regional or distant metastasis), a new primary melanoma, or death from any cause in the intention-to-treat population. Secondary endpoints include distant metastasis-free survival and safety, and exploratory endpoints include distribution of TMB expression in baseline tumor samples across study arms and their association with the primary RFS endpoint.

Key eligibility criteria for the trial included: patients with resectable cutaneous melanoma metastatic to a lymph node and at high risk of recurrence, patients with complete resection within 13 weeks prior to the first dose of KEYTRUDA, patients were disease free at study entry (after surgery) with no loco-regional relapse or distant metastasis and no clinical evidence of brain metastases, patients had a formalin fixed paraffin embedded (FFPE) tumor sample available suitable for sequencing, Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1 and patients with normal organ and marrow function reported at screening.

About melanoma

Melanoma, the most serious form of skin cancer, is characterized by the uncontrolled growth of pigment-producing cells. The rates of melanoma have been rising over the past few decades, with more than 330,000 new cases diagnosed worldwide in 2022. In the U.S., skin cancer is one of the most common types of cancer diagnosed, and melanoma accounts for a large majority of skin cancer deaths. It is estimated there will be about 112,000 new cases of melanoma diagnosed and over 8,500 deaths resulting from the disease in the U.S. in 2026.

About KEYTRUDA ® (pembrolizumab) injection for intravenous use, 100 mg

KEYTRUDA is an anti-programmed death receptor-1 (PD-1) therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.

Merck has the industry’s largest immuno-oncology clinical research program. There are currently more than 2,800 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient’s likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers.

Selected KEYTRUDA ® (pembrolizumab) Indications in the U.S.

Melanoma

KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic melanoma.

KEYTRUDA is indicated for the adjuvant treatment of adult and pediatric (12 years and older) patients with Stage IIB, IIC, or III melanoma following complete resection.

See additional selected KEYTRUDA indications in the U.S. after the Selected Important Safety Information.

Selected Important Safety Information for KEYTRUDA

Severe and Fatal Immune-Mediated Adverse Reactions

KEYTRUDA is a monoclonal antibody that belongs to a class of drugs that bind to either the programmed death receptor-1 (PD-1) or the programmed death ligand 1 (PD-L1), blocking the PD-1/PD-L1 pathway, thereby removing inhibition of the immune response, potentially breaking peripheral tolerance and inducing immune-mediated adverse reactions. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue, can affect more than one body system simultaneously, and can occur at any time after starting treatment or after discontinuation of treatment. Important immune-mediated adverse reactions listed here may not include all possible severe and fatal immune-mediated adverse reactions.

Monitor patients closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions. Early identification and management are essential to ensure safe use of anti–PD-1/PD-L1 treatments. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. For patients with TNBC treated with KEYTRUDA in the neoadjuvant setting, monitor blood cortisol at baseline, prior to surgery, and as clinically indicated. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate.

Withhold or permanently discontinue KEYTRUDA depending on severity of the immune-mediated adverse reaction. In general, if KEYTRUDA requires interruption or discontinuation, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose adverse reactions are not controlled with corticosteroid therapy.

Immune-Mediated Pneumonitis

KEYTRUDA can cause immune-mediated pneumonitis. The incidence is higher in patients who have received prior thoracic radiation. Immune-mediated pneumonitis occurred in 3.4% (94/2799) of patients receiving KEYTRUDA, including fatal (0.1%), Grade 4 (0.3%), Grade 3 (0.9%), and Grade 2 (1.3%) reactions. Systemic corticosteroids were required in 67% (63/94) of patients. Pneumonitis led to permanent discontinuation of KEYTRUDA in 1.3% (36) and withholding in 0.9% (26) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, 23% had recurrence. Pneumonitis resolved in 59% of the 94 patients.

Pneumonitis occurred in 8% (31/389) of adult patients with cHL receiving KEYTRUDA as a single agent, including Grades 3-4 in 2.3% of patients. Patients received high-dose corticosteroids for a median duration of 10 days (range: 2 days to 53 months). Pneumonitis rates were similar in patients with and without prior thoracic radiation. Pneumonitis led to discontinuation of KEYTRUDA in 5.4% (21) of patients. Of the patients who developed pneumonitis, 42% interrupted KEYTRUDA, 68% discontinued KEYTRUDA, and 77% had resolution.

Pneumonitis occurred in 7% (41/580) of adult patients with resected NSCLC who received KEYTRUDA as a single agent for adjuvant treatment of NSCLC, including fatal (0.2%), Grade 4 (0.3%), and Grade 3 (1%) adverse reactions. Patients received high-dose corticosteroids for a median duration of 10 days (range: 1 day to 2.3 months). Pneumonitis led to discontinuation of KEYTRUDA in 26 (4.5%) of patients. Of the patients who developed pneumonitis, 54% interrupted KEYTRUDA, 63% discontinued KEYTRUDA, and 71% had resolution.

Immune-Mediated Colitis

KEYTRUDA can cause immune-mediated colitis, which may present with diarrhea. Cytomegalovirus infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies. Immune-mediated colitis occurred in 1.7% (48/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (1.1%), and Grade 2 (0.4%) reactions. Systemic corticosteroids were required in 69% (33/48); additional immunosuppressant therapy was required in 4.2% of patients. Colitis led to permanent discontinuation of KEYTRUDA in 0.5% (15) and withholding in 0.5% (13) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, 23% had recurrence. Colitis resolved in 85% of the 48 patients.

Hepatotoxicity and Immune-Mediated Hepatitis

KEYTRUDA as a Single Agent

KEYTRUDA can cause immune-mediated hepatitis. Immune-mediated hepatitis occurred in 0.7% (19/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (0.4%), and Grade 2 (0.1%) reactions. Systemic corticosteroids were required in 68% (13/19) of patients; additional immunosuppressant therapy was required in 11% of patients. Hepatitis led to permanent discontinuation of KEYTRUDA in 0.2% (6) and withholding in 0.3% (9) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, none had recurrence. Hepatitis resolved in 79% of the 19 patients.

KEYTRUDA With Axitinib

KEYTRUDA in combination with axitinib can cause hepatic toxicity. Monitor liver enzymes before initiation of and periodically throughout treatment. Consider monitoring more frequently as compared to when the drugs are administered as single agents. For elevated liver enzymes, interrupt KEYTRUDA and axitinib, and consider administering corticosteroids as needed. With the combination of KEYTRUDA and axitinib, Grades 3 and 4 increased alanine aminotransferase (ALT) (20%) and increased aspartate aminotransferase (AST) (13%) were seen at a higher frequency compared to KEYTRUDA alone. Fifty-nine percent of the patients with increased ALT received systemic corticosteroids. In patients with ALT ≥3 times upper limit of normal (ULN) (Grades 2-4, n=116), ALT resolved to Grades 0-1 in 94%. Among the 92 patients who were rechallenged with either KEYTRUDA (n=3) or axitinib (n=34) administered as a single agent or with both (n=55), recurrence of ALT ≥3 times ULN was observed in 1 patient receiving KEYTRUDA, 16 patients receiving axitinib, and 24 patients receiving both. All patients with a recurrence of ALT ≥3 ULN subsequently recovered from the event.

Immune-Mediated Endocrinopathies

Adrenal Insufficiency

KEYTRUDA can cause primary or secondary adrenal insufficiency. For Grade 2 or higher, initiate symptomatic treatment, including hormone replacement as clinically indicated. Withhold KEYTRUDA depending on severity. Adrenal insufficiency occurred in 0.8% (22/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (0.3%), and Grade 2 (0.3%) reactions. Systemic corticosteroids were required in 77% (17/22) of patients; of these, the majority remained on systemic corticosteroids. Adrenal insufficiency led to permanent discontinuation of KEYTRUDA in <0.1% (1) and withholding in 0.3% (8) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement.

Hypophysitis

KEYTRUDA can cause immune-mediated hypophysitis. Hypophysitis can present with acute symptoms associated with mass effect such as headache, photophobia, or visual field defects. Hypophysitis can cause hypopituitarism. Initiate hormone replacement as indicated. Withhold or permanently discontinue KEYTRUDA depending on severity. Hypophysitis occurred in 0.6% (17/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (0.3%), and Grade 2 (0.2%) reactions. Systemic corticosteroids were required in 94% (16/17) of patients; of these, the majority remained on systemic corticosteroids. Hypophysitis led to permanent discontinuation of KEYTRUDA in 0.1% (4) and withholding in 0.3% (7) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement.

Thyroid Disorders

KEYTRUDA can cause immune-mediated thyroid disorders. Thyroiditis can present with or without endocrinopathy. Hypothyroidism can follow hyperthyroidism. Initiate hormone replacement for hypothyroidism or institute medical management of hyperthyroidism as clinically indicated. Withhold or permanently discontinue KEYTRUDA depending on severity. Thyroiditis occurred in 0.6% (16/2799) of patients receiving KEYTRUDA, including Grade 2 (0.3%). None discontinued, but KEYTRUDA was withheld in <0.1% (1) of patients.

Hyperthyroidism occurred in 3.4% (96/2799) of patients receiving KEYTRUDA, including Grade 3 (0.1%) and Grade 2 (0.8%). It led to permanent discontinuation of KEYTRUDA in <0.1% (2) and withholding in 0.3% (7) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement. Hypothyroidism occurred in 8% (237/2799) of patients receiving KEYTRUDA, including Grade 3 (0.1%) and Grade 2 (6.2%). It led to permanent discontinuation of KEYTRUDA in <0.1% (1) and withholding in 0.5% (14) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement. The majority of patients with hypothyroidism required long-term thyroid hormone replacement. The incidence of new or worsening hypothyroidism was higher in 1185 patients with HNSCC, occurring in 16% of patients receiving KEYTRUDA as a single agent or in combination with platinum and FU, including Grade 3 (0.3%) hypothyroidism. The incidence of new or worsening hypothyroidism was higher in 389 adult patients with cHL (17%) receiving KEYTRUDA as a single agent, including Grade 1 (6.2%) and Grade 2 (10.8%) hypothyroidism. The incidence of new or worsening hyperthyroidism was higher in 580 patients with resected NSCLC, occurring in 11% of patients receiving KEYTRUDA as a single agent as adjuvant treatment, including Grade 3 (0.2%) hyperthyroidism. The incidence of new or worsening hypothyroidism was higher in 580 patients with resected NSCLC, occurring in 22% of patients receiving KEYTRUDA as a single agent as adjuvant treatment (KEYNOTE-091), including Grade 3 (0.3%) hypothyroidism.

Type 1 Diabetes Mellitus (DM), Which Can Present With Diabetic Ketoacidosis

Monitor patients for hyperglycemia or other signs and symptoms of diabetes. Initiate treatment with insulin as clinically indicated. Withhold KEYTRUDA depending on severity. Type 1 DM occurred in 0.2% (6/2799) of patients receiving KEYTRUDA. It led to permanent discontinuation in <0.1% (1) and withholding of KEYTRUDA in <0.1% (1) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement.

Immune-Mediated Nephritis With Renal Dysfunction

KEYTRUDA can cause immune-mediated nephritis. Immune-mediated nephritis occurred in 0.3% (9/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (0.1%), and Grade 2 (0.1%) reactions. Systemic corticosteroids were required in 89% (8/9) of patients. Nephritis led to permanent discontinuation of KEYTRUDA in 0.1% (3) and withholding in 0.1% (3) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, none had recurrence. Nephritis resolved in 56% of the 9 patients.

Immune-Mediated Dermatologic Adverse Reactions

KEYTRUDA can cause immune-mediated rash or dermatitis. Exfoliative dermatitis, including Stevens-Johnson syndrome, drug rash with eosinophilia and systemic symptoms, and toxic epidermal necrolysis, has occurred with anti– PD-1/PD-L1 treatments. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate nonexfoliative rashes. Withhold or permanently discontinue KEYTRUDA depending on severity. Immune-mediated dermatologic adverse reactions occurred in 1.4% (38/2799) of patients receiving KEYTRUDA, including Grade 3 (1%) and Grade 2 (0.1%) reactions. Systemic corticosteroids were required in 40% (15/38) of patients. These reactions led to permanent discontinuation in 0.1% (2) and withholding of KEYTRUDA in 0.6% (16) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, 6% had recurrence. The reactions resolved in 79% of the 38 patients.

Other Immune-Mediated Adverse Reactions

The following clinically significant immune-mediated adverse reactions occurred at an incidence of <1% (unless otherwise noted) in patients who received KEYTRUDA or were reported with the use of other anti–PD-1/PD-L1 treatments. Severe or fatal cases have been reported for some of these adverse reactions. Cardiac/Vascular: Myocarditis, pericarditis, vasculitis; Nervous System: Meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome/myasthenia gravis (including exacerbation), Guillain-Barré syndrome, nerve paresis, autoimmune neuropathy; Ocular: Uveitis, iritis and other ocular inflammatory toxicities can occur. Some cases can be associated with retinal detachment. Various grades of visual impairment, including blindness, can occur. If uveitis occurs in combination with other immune-mediated adverse reactions, consider a Vogt-Koyanagi-Harada-like syndrome, as this may require treatment with systemic steroids to reduce the risk of permanent vision loss; Gastrointestinal: Pancreatitis, to include increases in serum amylase and lipase levels, gastritis, duodenitis; Musculoskeletal and Connective Tissue: Myositis/polymyositis, rhabdomyolysis (and associated sequelae, including renal failure), arthritis (1.5%), polymyalgia rheumatica; Endocrine: Hypoparathyroidism; Hematologic/Immune: Hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis, systemic inflammatory response syndrome, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, immune thrombocytopenic purpura, solid organ transplant rejection, other transplant (including corneal graft) rejection; Other : Myocarditis-Myositis-Myasthenia Gravis (or Myasthenia-Like) Overlap syndrome, reported as the co-occurrence of either two or all three adverse reactions.

Infusion-Related Reactions

KEYTRUDA can cause severe or life-threatening infusion-related reactions, including hypersensitivity and anaphylaxis, which have been reported in 0.2% of 2799 patients receiving KEYTRUDA. Monitor for signs and symptoms of infusion-related reactions. Interrupt or slow the rate of infusion for Grade 1 or Grade 2 reactions. For Grade 3 or Grade 4 reactions, stop infusion and permanently discontinue KEYTRUDA.

Complications of Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)

Fatal and other serious complications can occur in patients who receive allogeneic HSCT before or after anti–PD-1/PD-L1 treatments. Transplant-related complications include hyperacute graft-versus-host disease (GVHD), acute and chronic GVHD, hepatic veno-occlusive disease after reduced intensity conditioning, and steroid-requiring febrile syndrome (without an identified infectious cause). These complications may occur despite intervening therapy between anti–PD-1/PD-L1 treatments and allogeneic HSCT. Follow patients closely for evidence of these complications and intervene promptly. Consider the benefit vs risks of using anti–PD-1/PD-L1 treatments prior to or after an allogeneic HSCT.

Increased Mortality in Patients With Multiple Myeloma

In trials in patients with multiple myeloma, the addition of KEYTRUDA to a thalidomide analogue plus dexamethasone resulted in increased mortality. Treatment of these patients with an anti–PD-1/PD-L1 treatment in this combination is not recommended outside of controlled trials.

Embryofetal Toxicity

Based on its mechanism of action, KEYTRUDA can cause fetal harm when administered to a pregnant woman. Advise women of this potential risk. In females of reproductive potential, verify pregnancy status prior to initiating KEYTRUDA and advise them to use effective contraception during treatment and for 4 months after the last dose.

Adverse Reactions

In KEYNOTE-006, KEYTRUDA was discontinued due to adverse reactions in 9% of 555 patients with advanced melanoma; adverse reactions leading to permanent discontinuation in more than one patient were colitis (1.4%), autoimmune hepatitis (0.7%), allergic reaction (0.4%), polyneuropathy (0.4%), and cardiac failure (0.4%). The most common adverse reactions (≥20%) with KEYTRUDA were fatigue (28%), diarrhea (26%), rash (24%), and nausea (21%).

In KEYNOTE-054, when KEYTRUDA was administered as a single agent to patients with stage III melanoma, KEYTRUDA was permanently discontinued due to adverse reactions in 14% of 509 patients; the most common (≥1%) were pneumonitis (1.4%), colitis (1.2%), and diarrhea (1%). Serious adverse reactions occurred in 25% of patients receiving KEYTRUDA. The most common adverse reaction (≥20%) with KEYTRUDA was diarrhea (28%). In KEYNOTE-716, when KEYTRUDA was administered as a single agent to patients with stage IIB or IIC melanoma, adverse reactions occurring in patients with stage IIB or IIC melanoma were similar to those occurring in 1011 patients with stage III melanoma from KEYNOTE-054.

In KEYNOTE-189, when KEYTRUDA was administered with pemetrexed and platinum chemotherapy in metastatic nonsquamous NSCLC, KEYTRUDA was discontinued due to adverse reactions in 20% of 405 patients. The most common adverse reactions resulting in permanent discontinuation of KEYTRUDA were pneumonitis (3%) and acute kidney injury (2%). The most common adverse reactions (≥20%) with KEYTRUDA were nausea (56%), fatigue (56%), constipation (35%), diarrhea (31%), decreased appetite (28%), rash (25%), vomiting (24%), cough (21%), dyspnea (21%), and pyrexia (20%).

In KEYNOTE-407, when KEYTRUDA was administered with carboplatin and either paclitaxel or paclitaxel protein-bound in metastatic squamous NSCLC, KEYTRUDA was discontinued due to adverse reactions in 15% of 101 patients. The most frequent serious adverse reactions reported in at least 2% of patients were febrile neutropenia, pneumonia, and urinary tract infection. Adverse reactions observed in KEYNOTE-407 were similar to those observed in KEYNOTE-189 with the exception that increased incidences of alopecia (47% vs 36%) and peripheral neuropathy (31% vs 25%) were observed in the KEYTRUDA and chemotherapy arm compared to the placebo and chemotherapy arm in KEYNOTE-407.

In KEYNOTE-042, KEYTRUDA was discontinued due to adverse reactions in 19% of 636 patients with advanced NSCLC; the most common were pneumonitis (3%), death due to unknown cause (1.6%), and pneumonia (1.4%). The most frequent serious adverse reactions reported in at least 2% of patients were pneumonia (7%), pneumonitis (3.9%), pulmonary embolism (2.4%), and pleural effusion (2.2%). The most common adverse reaction (≥20%) was fatigue (25%).

In KEYNOTE-010, KEYTRUDA monotherapy was discontinued due to adverse reactions in 8% of 682 patients with metastatic NSCLC; the most common was pneumonitis (1.8%). The most common adverse reactions (≥20%) were decreased appetite (25%), fatigue (25%), dyspnea (23%), and nausea (20%).

In KEYNOTE-671, adverse reactions occurring in patients with resectable NSCLC receiving KEYTRUDA in combination with platinum-containing chemotherapy, given as neoadjuvant treatment and continued as single-agent adjuvant treatment, were generally similar to those occurring in patients in other clinical trials across tumor types receiving KEYTRUDA in combination with chemotherapy.

The most common adverse reactions (reported in ≥20%) in patients receiving KEYTRUDA in combination with chemotherapy or chemoradiotherapy were fatigue/asthenia, nausea, constipation, diarrhea, decreased appetite, rash, vomiting, cough, dyspnea, pyrexia, alopecia, peripheral neuropathy, mucosal inflammation, stomatitis, headache, weight loss, abdominal pain, arthralgia, myalgia, insomnia, palmar-plantar erythrodysesthesia, urinary tract infection, hypothyroidism, radiation skin injury, dysphagia, dry mouth, and musculoskeletal pain.

In the neoadjuvant phase of KEYNOTE-671, when KEYTRUDA was administered in combination with platinum-containing chemotherapy as neoadjuvant treatment, serious adverse reactions occurred in 34% of 396 patients. The most frequent (≥2%) serious adverse reactions were pneumonia (4.8%), venous thromboembolism (3.3%), and anemia (2%). Fatal adverse reactions occurred in 1.3% of patients, including death due to unknown cause (0.8%), sepsis (0.3%), and immune-mediated lung disease (0.3%). Permanent discontinuation of any study drug due to an adverse reaction occurred in 18% of patients who received KEYTRUDA in combination with platinum-containing chemotherapy; the most frequent adverse reactions (≥1%) that led to permanent discontinuation of any study drug were acute kidney injury (1.8%), interstitial lung disease (1.8%), anemia (1.5%), neutropenia (1.5%), and pneumonia (1.3%).

Of the KEYTRUDA-treated patients who received neoadjuvant treatment, 6% of 396 patients did not receive surgery due to adverse reactions. The most frequent (≥1%) adverse reaction that led to cancellation of surgery in the KEYTRUDA arm was interstitial lung disease (1%).

In the adjuvant phase of KEYNOTE-671, when KEYTRUDA was administered as a single agent as adjuvant treatment, serious adverse reactions occurred in 14% of 290 patients. The most frequent serious adverse reaction was pneumonia (3.4%). One fatal adverse reaction of pulmonary hemorrhage occurred. Permanent discontinuation of KEYTRUDA due to an adverse reaction occurred in 12% of patients who received KEYTRUDA as a single agent, given as adjuvant treatment; the most frequent adverse reactions (≥1%) that led to permanent discontinuation of KEYTRUDA were diarrhea (1.7%), interstitial lung disease (1.4%), increased aspartate aminotransferase (1%), and musculoskeletal pain (1%).

Adverse reactions observed in KEYNOTE-091 were generally similar to those occurring in other patients with NSCLC receiving KEYTRUDA as a single agent, with the exception of hypothyroidism (22%), hyperthyroidism (11%), and pneumonitis (7%). Two fatal adverse reactions of myocarditis occurred.

Adverse reactions observed in KEYNOTE-483 were generally similar to those occurring in other patients receiving KEYTRUDA in combination with pemetrexed and platinum chemotherapy.

In KEYNOTE-689, the most common adverse reactions (≥20%) in patients receiving KEYTRUDA were stomatitis (48%), radiation skin injury (40%), weight loss (36%), fatigue (33%), dysphagia (29%), constipation (27%), hypothyroidism (26%), nausea (24%), rash (22%), dry mouth (22%), diarrhea (22%), and musculoskeletal pain (22%).

In the neoadjuvant phase of KEYNOTE-689, of the 361 patients who received at least one dose of single agent KEYTRUDA, 11% experienced serious adverse reactions. Serious adverse reactions that occurred in more than one patient were pneumonia (1.4%), tumor hemorrhage (0.8%), dysphagia (0.6%), immune-mediated hepatitis (0.6%), cellulitis (0.6%), and dyspnea (0.6%). Fatal adverse reactions occurred in 1.1% of patients, including respiratory failure, clostridium infection, septic shock, and myocardial infarction (one patient each). Permanent discontinuation of KEYTRUDA due to an adverse reaction occurred in 2.8% of patients who received KEYTRUDA as neoadjuvant treatment. The most frequent adverse reaction which resulted in permanent discontinuation of neoadjuvant KEYTRUDA in more than one patient was arthralgia (0.6%).

Of the 361 patients who received KEYTRUDA as neoadjuvant treatment, 11% did not receive surgery. Surgical cancellation on the KEYTRUDA arm was due to disease progression in 4%, patient decision in 3%, adverse reactions in 1.4%, physician’s decision in 1.1%, unresectable tumor in 0.6%, loss of follow-up in 0.3%, and use of non-study anti-cancer therapy in 0.3%.

Of the 323 KEYTRUDA-treated patients who received surgery following the neoadjuvant phase, 1.2% experienced delay of surgery (defined as on-study surgery occurring ≥9 weeks after initiation of neoadjuvant KEYTRUDA) due to adverse reactions, and 2.8% did not receive adjuvant treatment due to adverse reactions.

In the adjuvant phase of KEYNOTE-689, of the 255 patients who received at least one dose of KEYTRUDA, 38% experienced serious adverse reactions. The most frequent serious adverse reactions reported in ≥1% of KEYTRUDA- treated patients were pneumonia (2.7%), pyrexia (2.4%), stomatitis (2.4%), acute kidney injury (2.0%), pneumonitis (1.6%), COVID-19 (1.2%), death not otherwise specified (1.2%), diarrhea (1.2%), dysphagia (1.2%), gastrostomy tube site complication (1.2%), and immune-mediated hepatitis (1.2%). Fatal adverse reactions occurred in 5% of patients, including death not otherwise specified (1.2%), acute renal failure (0.4%), hypercalcemia (0.4%), pulmonary hemorrhage (0.4%), dysphagia/malnutrition (0.4%), mesenteric thrombosis (0.4%), sepsis (0.4%), pneumonia (0.4%), COVID-19 (0.4%), respiratory failure (0.4%), cardiovascular disorder (0.4%), and gastrointestinal hemorrhage (0.4%). Permanent discontinuation of adjuvant KEYTRUDA due to an adverse reaction occurred in 17% of patients. The most frequent (≥1%) adverse reactions that led to permanent discontinuation of adjuvant KEYTRUDA were pneumonitis, colitis, immune-mediated hepatitis, and death not otherwise specified.

In KEYNOTE-048, KEYTRUDA monotherapy was discontinued due to adverse events in 12% of 300 patients with HNSCC; the most common adverse reactions leading to permanent discontinuation were sepsis (1.7%) and pneumonia (1.3%). The most common adverse reactions (≥20%) were fatigue (33%), constipation (20%), and rash (20%).

In KEYNOTE-048, when KEYTRUDA was administered in combination with platinum (cisplatin or carboplatin) and FU chemotherapy, KEYTRUDA was discontinued due to adverse reactions in 16% of 276 patients with HNSCC. The most common adverse reactions resulting in permanent discontinuation of KEYTRUDA were pneumonia (2.5%), pneumonitis (1.8%), and septic shock (1.4%). The most common adverse reactions (≥20%) were nausea (51%), fatigue (49%), constipation (37%), vomiting (32%), mucosal inflammation (31%), diarrhea (29%), decreased appetite (29%), stomatitis (26%), and cough (22%).

In KEYNOTE-012, KEYTRUDA was discontinued due to adverse reactions in 17% of 192 patients with HNSCC. Serious adverse reactions occurred in 45% of patients. The most frequent serious adverse reactions reported in at least 2% of patients were pneumonia, dyspnea, confusional state, vomiting, pleural effusion, and respiratory failure. The most common adverse reactions (≥20%) were fatigue, decreased appetite, and dyspnea. Adverse reactions occurring in patients with HNSCC were generally similar to those occurring in patients with melanoma or NSCLC who received KEYTRUDA as a monotherapy, with the exception of increased incidences of facial edema and new or worsening hypothyroidism.

In KEYNOTE-204, KEYTRUDA was discontinued due to adverse reactions in 14% of 148 patients with cHL. Serious adverse reactions occurred in 30% of patients receiving KEYTRUDA; those ≥1% were pneumonitis, pneumonia, pyrexia, myocarditis, acute kidney injury, febrile neutropenia, and sepsis. Three patients died from causes other than disease progression: 2 from complications after allogeneic HSCT and 1 from unknown cause. The most common adverse reactions (≥20%) were upper respiratory tract infection (41%), musculoskeletal pain (32%), diarrhea (22%), and pyrexia, fatigue, rash, and cough (20% each).

In KEYNOTE-087, KEYTRUDA was discontinued due to adverse reactions in 5% of 210 patients with cHL. Serious adverse reactions occurred in 16% of patients; those ≥1% were pneumonia, pneumonitis, pyrexia, dyspnea, GVHD, and herpes zoster. Two patients died from causes other than disease progression: 1 from GVHD after subsequent allogeneic HSCT and 1 from septic shock. The most common adverse reactions (≥20%) were fatigue (26%), pyrexia (24%), cough (24%), musculoskeletal pain (21%), diarrhea (20%), and rash (20%).

In KEYNOTE-170, KEYTRUDA was discontinued due to adverse reactions in 8% of 53 patients with PMBCL. Serious adverse reactions occurred in 26% of patients and included arrhythmia (4%), cardiac tamponade (2%), myocardial infarction (2%), pericardial effusion (2%), and pericarditis (2%). Six (11%) patients died within 30 days of start of treatment. The most common adverse reactions (≥20%) were musculoskeletal pain (30%), upper respiratory tract infection and pyrexia (28% each), cough (26%), fatigue (23%), and dyspnea (21%).

In KEYNOTE-A39, when KEYTRUDA was administered in combination with enfortumab vedotin to patients with locally advanced or metastatic urothelial cancer (n=440), fatal adverse reactions occurred in 3.9% of patients, including acute respiratory failure (0.7%), pneumonia (0.5%), and pneumonitis/ILD (0.2%). Serious adverse reactions occurred in 50% of patients receiving KEYTRUDA in combination with enfortumab vedotin; the serious adverse reactions in ≥2% of patients were rash (6%), acute kidney injury (5%), pneumonitis/ILD (4.5%), urinary tract infection (3.6%), diarrhea (3.2%), pneumonia (2.3%), pyrexia (2%), and hyperglycemia (2%). Permanent discontinuation of KEYTRUDA occurred in 27% of patients. The most common adverse reactions (≥2%) resulting in permanent discontinuation of KEYTRUDA were pneumonitis/ILD (4.8%) and rash (3.4%). The most common adverse reactions (≥20%) occurring in patients treated with KEYTRUDA in combination with enfortumab vedotin were rash (68%), peripheral neuropathy (67%), fatigue (51%), pruritus (41%), diarrhea (38%), alopecia (35%), weight loss (33%), decreased appetite (33%), nausea (26%), constipation (26%), dry eye (24%), dysgeusia (21%), and urinary tract infection (21%).

In KEYNOTE-052, KEYTRUDA was discontinued due to adverse reactions in 11% of 370 patients with locally advanced or metastatic urothelial carcinoma. Serious adverse reactions occurred in 42% of patients; those ≥2% were urinary tract infection, hematuria, acute kidney injury, pneumonia, and urosepsis. The most common adverse reactions (≥20%) were fatigue (38%), musculoskeletal pain (24%), decreased appetite (22%), constipation (21%), rash (21%), and diarrhea (20%).

In KEYNOTE-045, KEYTRUDA was discontinued due to adverse reactions in 8% of 266 patients with locally advanced or metastatic urothelial carcinoma. The most common adverse reaction resulting in permanent discontinuation of KEYTRUDA was pneumonitis (1.9%). Serious adverse reactions occurred in 39% of KEYTRUDA-treated patients; those ≥2% were urinary tract infection, pneumonia, anemia, and pneumonitis. The most common adverse reactions (≥20%) in patients who received KEYTRUDA were fatigue (38%), musculoskeletal pain (32%), pruritus (23%), decreased appetite (21%), nausea (21%), and rash (20%).

In KEYNOTE-905, the most common adverse reactions (≥20%) occurring in cisplatin-ineligible patients with MIBC treated with KEYTRUDA in combination with enfortumab vedotin (n=167) were rash (54%), pruritus (47%), fatigue (47%), peripheral neuropathy (39%), alopecia (35%), dysgeusia (35%), diarrhea (34%), constipation (28%), decreased appetite (28%), nausea (26%), urinary tract infection (24%), dry eye (21%), and weight loss (20%).

In the neoadjuvant phase of KEYNOTE-905, serious adverse reactions occurred in 27% (n=167) of patients; the most frequent (≥2%) were urinary tract infection (3.6%) and hematuria (2.4%). Fatal adverse reactions occurred in 1.2% of patients, including myasthenia gravis and toxic epidermal necrolysis (0.6% each). Additional fatal adverse reactions were reported in 2.7% of patients in the post-surgery phase before adjuvant treatment started, including sepsis and intestinal obstruction (1.4% each). Permanent discontinuation of KEYTRUDA due to an adverse reaction occurred in 15% of patients; the most frequent (>1%) were rash (2.4%, including generalized exfoliative dermatitis), increased alanine aminotransferase, increased aspartate aminotransferase, diarrhea, dysgeusia, and toxic epidermal necrolysis (1.2% each). Of the 167 patients in the KEYTRUDA in combination with enfortumab vedotin arm who received neoadjuvant treatment, 7 (4.2%) patients did not receive surgery due to adverse reactions. The adverse reactions that led to cancellation of surgery were acute myocardial infarction, bile duct cancer, colon cancer, respiratory distress, urinary tract infection, and the two deaths due to myasthenia gravis and toxic epidermal necrolysis (0.6% each).

Of the 146 patients who received neoadjuvant treatment with KEYTRUDA in combination with enfortumab vedotin and underwent radical cystectomy, 6 (4.1%) patients experienced delay of surgery (defined as time from last neoadjuvant treatment to surgery exceeding 8 weeks) due to adverse reactions.

In the adjuvant phase of KEYNOTE-905, serious adverse reactions occurred in 43% (n=100) of patients; the most frequent (≥2%) were urinary tract infection (8%); acute kidney injury and pyelonephritis (5% each); urosepsis (4%); and hypokalemia, intestinal obstruction, and sepsis (2% each). Fatal adverse reactions occurred in 7% of patients, including urosepsis, intracranial hemorrhage, death, myocardial infarction, multiple organ dysfunction syndrome, and pseudomonal pneumonia (1% each). Permanent discontinuation of KEYTRUDA due to an adverse reaction occurred in 28% of patients; the most frequent (>1%) were diarrhea (5%), peripheral neuropathy, acute kidney injury, and pneumonitis (2% each).

In KEYNOTE-057, KEYTRUDA was discontinued due to adverse reactions in 11% of 148 patients with high-risk NMIBC. The most common adverse reaction resulting in permanent discontinuation of KEYTRUDA was pneumonitis (1.4%). Serious adverse reactions occurred in 28% of patients; those ≥2% were pneumonia (3%), cardiac ischemia (2%), colitis (2%), pulmonary embolism (2%), sepsis (2%), and urinary tract infection (2%). The most common adverse reactions (≥20%) were fatigue (29%), diarrhea (24%), and rash (24%).

Adverse reactions occurring in patients with MSI-H or dMMR CRC were similar to those occurring in patients with melanoma or NSCLC who received KEYTRUDA as a monotherapy.

In KEYNOTE-158 and KEYNOTE-164, adverse reactions occurring in patients with MSI-H or dMMR cancer were similar to those occurring in patients with other solid tumors who received KEYTRUDA as a single agent.

In KEYNOTE-811, fatal adverse reactions occurred in 3 patients who received KEYTRUDA in combination with trastuzumab and CAPOX (capecitabine plus oxaliplatin) or FP (5-FU plus cisplatin) and included pneumonitis in 2 patients and hepatitis in 1 patient. KEYTRUDA was discontinued due to adverse reactions in 13% of 350 patients with locally advanced unresectable or metastatic HER2-positive gastric or GEJ adenocarcinoma. Adverse reactions resulting in permanent discontinuation of KEYTRUDA in ≥1% of patients were pneumonitis (2.0%) and pneumonia (1.1%). In the KEYTRUDA arm vs placebo, there was a difference of ≥5% incidence between patients treated with KEYTRUDA vs standard of care for diarrhea (53% vs 47%), rash (35% vs 28%), hypothyroidism (11% vs 5%), and pneumonia (11% vs 5%).

In KEYNOTE-859, when KEYTRUDA was administered in combination with fluoropyrimidine- and platinum-containing chemotherapy, serious adverse reactions occurred in 45% of 785 patients. Serious adverse reactions in >2% of patients included pneumonia (4.1%), diarrhea (3.9%), hemorrhage (3.9%), and vomiting (2.4%). Fatal adverse reactions occurred in 8% of patients who received KEYTRUDA, including infection (2.3%) and thromboembolism (1.3%). KEYTRUDA was permanently discontinued due to adverse reactions in 15% of patients. The most common adverse reactions resulting in permanent discontinuation of KEYTRUDA (≥1%) were infections (1.8%) and diarrhea (1.0%). The most common adverse reactions (reported in ≥20%) in patients receiving KEYTRUDA in combination with chemotherapy were peripheral neuropathy (47%), nausea (46%), fatigue (40%), diarrhea (36%), vomiting (34%), decreased appetite (29%), abdominal pain (26%), palmar-plantar erythrodysesthesia syndrome (25%), constipation (22%), and weight loss (20%).

In KEYNOTE-590, when KEYTRUDA was administered with cisplatin and fluorouracil to patients with metastatic or locally advanced esophageal or GEJ (tumors with epicenter 1 to 5 centimeters above the GEJ) carcinoma who were not candidates for surgical resection or definitive chemoradiation, KEYTRUDA was discontinued due to adverse reactions in 15% of 370 patients. The most common adverse reactions resulting in permanent discontinuation of KEYTRUDA (≥1%) were pneumonitis (1.6%), acute kidney injury (1.1%), and pneumonia (1.1%). The most common adverse reactions (≥20%) with KEYTRUDA in combination with chemotherapy were nausea (67%), fatigue (57%), decreased appetite (44%), constipation (40%), diarrhea (36%), vomiting (34%), stomatitis (27%), and weight loss (24%).

Adverse reactions occurring in patients with esophageal cancer who received KEYTRUDA as a monotherapy were similar to those occurring in patients with melanoma or NSCLC who received KEYTRUDA as a monotherapy.

In KEYNOTE-A18, when KEYTRUDA was administered with CRT (cisplatin plus external beam radiation therapy [EBRT] followed by brachytherapy [BT]) to patients with FIGO 2014 Stage III-IVA cervical cancer, fatal adverse reactions occurred in 1.4% of 294 patients, including 1 case each (0.3%) of large intestinal perforation, urosepsis, sepsis, and vaginal hemorrhage. Serious adverse reactions occurred in 34% of patients; those ≥1% included urinary tract infection (3.1%), urosepsis (1.4%), and sepsis (1%). KEYTRUDA was discontinued for adverse reactions in 9% of patients. The most common adverse reaction (≥1%) resulting in permanent discontinuation was diarrhea (1%). For patients treated with KEYTRUDA in combination with CRT, the most common adverse reactions (≥10%) were nausea (56%), diarrhea (51%), urinary tract infection (35%), vomiting (34%), fatigue (28%), hypothyroidism (23%), constipation (20%), weight loss (19%), decreased appetite (18%), pyrexia (14%), abdominal pain and hyperthyroidism (13% each), dysuria and rash (12% each), back and pelvic pain (11% each), and COVID-19 (10%).

In KEYNOTE-826, when KEYTRUDA was administered in combination with paclitaxel and cisplatin or paclitaxel and carboplatin, with or without bevacizumab (n=307), to patients with persistent, recurrent, or first-line metastatic cervical cancer regardless of tumor PD-L1 expression who had not been treated with chemotherapy except when used concurrently as a radio-sensitizing agent, fatal adverse reactions occurred in 4.6% of patients, including 3 cases of hemorrhage, 2 cases each of sepsis and due to unknown causes, and 1 case each of acute myocardial infarction, autoimmune encephalitis, cardiac arrest, cerebrovascular accident, femur fracture with perioperative pulmonary embolus, intestinal perforation, and pelvic infection. Serious adverse reactions occurred in 50% of patients receiving KEYTRUDA in combination with chemotherapy with or without bevacizumab; those ≥3% were febrile neutropenia (6.8%), urinary tract infection (5.2%), anemia (4.6%), and acute kidney injury and sepsis (3.3% each).

KEYTRUDA was discontinued in 15% of patients due to adverse reactions. The most common adverse reaction resulting in permanent discontinuation (≥1%) was colitis (1%).

For patients treated with KEYTRUDA, chemotherapy, and bevacizumab (n=196), the most common adverse reactions (≥20%) were peripheral neuropathy (62%), alopecia (58%), anemia (55%), fatigue/asthenia (53%), nausea and neutropenia (41% each), diarrhea (39%), hypertension and thrombocytopenia (35% each), constipation and arthralgia (31% each), vomiting (30%), urinary tract infection (27%), rash (26%), leukopenia (24%), hypothyroidism (22%), and decreased appetite (21%).

For patients treated with KEYTRUDA in combination with chemotherapy with or without bevacizumab, the most common adverse reactions (≥20%) were peripheral neuropathy (58%), alopecia (56%), fatigue (47%), nausea (40%), diarrhea (36%), constipation (28%), arthralgia (27%), vomiting (26%), hypertension and urinary tract infection (24% each), and rash (22%).

In KEYNOTE-158, KEYTRUDA was discontinued due to adverse reactions in 8% of 98 patients with previously treated recurrent or metastatic cervical cancer. Serious adverse reactions occurred in 39% of patients receiving KEYTRUDA; the most frequent included anemia (7%), fistula, hemorrhage, and infections [except urinary tract infections] (4.1% each). The most common adverse reactions (≥20%) were fatigue (43%), musculoskeletal pain (27%), diarrhea (23%), pain and abdominal pain (22% each), and decreased appetite (21%).

In KEYNOTE-394, KEYTRUDA was discontinued due to adverse reactions in 13% of 299 patients with previously treated hepatocellular carcinoma. The most common adverse reaction resulting in permanent discontinuation of KEYTRUDA was ascites (2.3%). The most common adverse reactions in patients receiving KEYTRUDA (≥10%) were pyrexia (18%), rash (18%), diarrhea (16%), decreased appetite (15%), pruritus (12%), upper respiratory tract infection (11%), cough (11%), and hypothyroidism (10%).

In KEYNOTE-966, when KEYTRUDA was administered in combination with gemcitabine and cisplatin, KEYTRUDA was discontinued for adverse reactions in 15% of 529 patients with locally advanced unresectable or metastatic biliary tract cancer. The most common adverse reaction resulting in permanent discontinuation of KEYTRUDA (≥1%) was pneumonitis (1.3%). Adverse reactions leading to the interruption of KEYTRUDA occurred in 55% of patients. The most common adverse reactions or laboratory abnormalities leading to interruption of KEYTRUDA (≥2%) were decreased neutrophil count (18%), decreased platelet count (10%), anemia (6%), decreased white blood cell count (4%), pyrexia (3.8%), fatigue (3.0%), cholangitis (2.8%), increased ALT (2.6%), increased AST (2.5%), and biliary obstruction (2.3%).

In KEYNOTE-017 and KEYNOTE-913, adverse reactions occurring in patients with MCC (n=105) were generally similar to those occurring in patients with melanoma or NSCLC who received KEYTRUDA as a single agent.

In KEYNOTE-426, when KEYTRUDA was administered in combination with axitinib, fatal adverse reactions occurred in 3.3% of 429 patients. Serious adverse reactions occurred in 40% of patients, the most frequent (≥1%) were hepatotoxicity (7%), diarrhea (4.2%), acute kidney injury (2.3%), dehydration (1%), and pneumonitis (1%). Permanent discontinuation due to an adverse reaction occurred in 31% of patients; KEYTRUDA only (13%), axitinib only (13%), and the combination (8%); the most common were hepatotoxicity (13%), diarrhea/colitis (1.9%), acute kidney injury (1.6%), and cerebrovascular accident (1.2%). The most common adverse reactions (≥20%) were diarrhea (56%), fatigue/asthenia (52%), hypertension (48%), hepatotoxicity (39%), hypothyroidism (35%), decreased appetite (30%), palmar-plantar erythrodysesthesia (28%), nausea (28%), stomatitis/mucosal inflammation (27%), dysphonia (25%), rash (25%), cough (21%), and constipation (21%).

In KEYNOTE-564, when KEYTRUDA was administered as a single agent for the adjuvant treatment of renal cell carcinoma, serious adverse reactions occurred in 20% of patients receiving KEYTRUDA; the serious adverse reactions (≥1%) were acute kidney injury, adrenal insufficiency, pneumonia, colitis, and diabetic ketoacidosis (1% each). Fatal adverse reactions occurred in 0.2% including 1 case of pneumonia. Discontinuation of KEYTRUDA due to adverse reactions occurred in 21% of 488 patients; the most common (≥1%) were increased ALT (1.6%), colitis (1%), and adrenal insufficiency (1%). The most common adverse reactions (≥20%) were musculoskeletal pain (41%), fatigue (40%), rash (30%), diarrhea (27%), pruritus (23%), and hypothyroidism (21%).

In KEYNOTE-868, when KEYTRUDA was administered in combination with chemotherapy (paclitaxel and carboplatin) to patients with advanced or recurrent endometrial carcinoma (n=382), serious adverse reactions occurred in 35% of patients receiving KEYTRUDA in combination with chemotherapy, compared to 19% of patients receiving placebo in combination with chemotherapy (n=377). Fatal adverse reactions occurred in 1.6% of patients receiving KEYTRUDA in combination with chemotherapy, including COVID-19 (0.5%) and cardiac arrest (0.3%). KEYTRUDA was discontinued for an adverse reaction in 14% of patients. Adverse reactions occurring in patients treated with KEYTRUDA and chemotherapy were generally similar to those observed with KEYTRUDA alone or chemotherapy alone, with the exception of rash (33% all Grades; 2.9% Grades 3-4).

Adverse reactions occurring in patients with MSI-H or dMMR endometrial carcinoma who received KEYTRUDA as a single agent were similar to those occurring in patients with melanoma or NSCLC who received KEYTRUDA as a single agent.

Adverse reactions occurring in patients with TMB-H cancer were similar to those occurring in patients with other solid tumors who received KEYTRUDA as a single agent.

Adverse reactions occurring in patients with recurrent or metastatic cSCC or locally advanced cSCC were similar to those occurring in patients with melanoma or NSCLC who received KEYTRUDA as a monotherapy.

In KEYNOTE-522, when KEYTRUDA was administered with neoadjuvant chemotherapy (carboplatin and paclitaxel followed by doxorubicin or epirubicin and cyclophosphamide) followed by surgery and continued adjuvant treatment with KEYTRUDA as a single agent (n=778) to patients with newly diagnosed, previously untreated, high-risk early-stage TNBC, fatal adverse reactions occurred in 0.9% of patients, including 1 each of adrenal crisis, autoimmune encephalitis, hepatitis, pneumonia, pneumonitis, pulmonary embolism, and sepsis in association with multiple organ dysfunction syndrome and myocardial infarction. Serious adverse reactions occurred in 44% of patients receiving KEYTRUDA; those ≥2% were febrile neutropenia (15%), pyrexia (3.7%), anemia (2.6%), and neutropenia (2.2%). KEYTRUDA was discontinued in 20% of patients due to adverse reactions. The most common reactions (≥1%) resulting in permanent discontinuation were increased ALT (2.7%), increased AST (1.5%), and rash (1%). The most common adverse reactions (≥20%) in patients receiving KEYTRUDA with chemotherapy followed by KEYTRUDA alone were fatigue (70%), nausea (67%), alopecia (61%), rash (52%), constipation (42%), diarrhea and peripheral neuropathy (41% each), stomatitis (34%), vomiting (31%), headache (30%), arthralgia (29%), pyrexia (28%), cough (26%), abdominal pain (24%), decreased appetite (23%), insomnia (21%), and myalgia (20%).

In KEYNOTE-355, when KEYTRUDA and chemotherapy (paclitaxel, paclitaxel protein-bound, or gemcitabine and carboplatin) were administered to patients with locally recurrent unresectable or metastatic TNBC who had not been previously treated with chemotherapy in the metastatic setting (n=596), fatal adverse reactions occurred in 2.5% of patients, including cardio-respiratory arrest (0.7%) and septic shock (0.3%). Serious adverse reactions occurred in 30% of patients receiving KEYTRUDA in combination with chemotherapy; the serious reactions in ≥2% were pneumonia (2.9%), anemia (2.2%), and thrombocytopenia (2%). KEYTRUDA was discontinued in 11% of patients due to adverse reactions. The most common reactions resulting in permanent discontinuation (≥1%) were increased ALT (2.2%), increased AST (1.5%), and pneumonitis (1.2%). The most common adverse reactions (≥20%) in patients receiving KEYTRUDA in combination with chemotherapy were fatigue (48%), nausea (44%), alopecia (34%), diarrhea and constipation (28% each), vomiting and rash (26% each), cough (23%), decreased appetite (21%), and headache (20%).

In KEYNOTE-B96, when KEYTRUDA was administered in combination with paclitaxel, with or without bevacizumab, serious adverse reactions occurred in 54% of patients. Serious adverse reactions in ≥2% of patients were pneumonia (4.3%), urinary tract infection (3.9%), adrenal insufficiency (3%), hyponatremia (3%), COVID-19, decreased neutrophil count, pulmonary embolism (2.6% each), abdominal pain, anemia, colitis, diarrhea, febrile neutropenia, pyrexia, and vomiting (2.1% each).

Fatal adverse reactions occurred in 3.9% of patients receiving KEYTRUDA and paclitaxel, with or without bevacizumab, including assisted suicide (0.9%), death, intestinal perforation, sepsis, COVID-19, cardio-respiratory arrest, colitis, and embolic stroke (0.4% each).

KEYTRUDA was permanently discontinued for adverse reactions in 16% of patients. The most common adverse reactions resulting in permanent discontinuation of KEYTRUDA (≥1%) were colitis and increased alanine aminotransferase (1.3% each). Adverse reactions leading to the interruption of KEYTRUDA occurred in 44% of patients. The most common adverse reactions leading to interruption of KEYTRUDA in ≥2% were urinary tract infection (3.9%), adrenal insufficiency, pyrexia, pneumonitis, upper respiratory tract infection (2.6% each), neutropenia, diarrhea, and COVID-19 (2.1% each).

The most common adverse reactions (≥20%) for patients treated with KEYTRUDA in combination with paclitaxel, with or without bevacizumab, were diarrhea (45%), fatigue (43%), nausea (41%), alopecia, peripheral neuropathy (38% each), epistaxis (31%), urinary tract infection (27%), constipation (25%), abdominal pain, decreased appetite, vomiting (24% each), hypothyroidism (21%), cough, hypertension, and rash (20% each).

For patients treated with KEYTRUDA in combination with paclitaxel and bevacizumab (N=169), decreased white blood cell count (27%), stomatitis (22%), and pyrexia (21%) were also reported as adverse reactions.

Lactation

Because of the potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment and for 4 months after the last dose.

Pediatric Use

In KEYNOTE-051, 173 pediatric patients (65 pediatric patients aged 6 months to younger than 12 years and 108 pediatric patients aged 12 years to 17 years) were administered KEYTRUDA 2 mg/kg every 3 weeks. The median duration of exposure was 2.1 months (range: 1 day to 25 months).

Adverse reactions that occurred at a ≥10% higher rate in pediatric patients when compared to adults were pyrexia (33%), leukopenia (30%), vomiting (29%), neutropenia (28%), headache (25%), abdominal pain (23%), thrombocytopenia (22%), Grade 3 anemia (17%), decreased lymphocyte count (13%), and decreased white blood cell count (11%).

Geriatric Use

Of the 564 patients with locally advanced or metastatic urothelial cancer treated with KEYTRUDA in combination with enfortumab vedotin, 44% (n=247) were 65-74 years and 26% (n=144) were 75 years or older. No overall differences in effectiveness were observed between patients 65 years of age or older and younger patients. Patients 75 years of age or older treated with KEYTRUDA in combination with enfortumab vedotin experienced a higher incidence of fatal adverse reactions than younger patients. The incidence of fatal adverse reactions was 4% in patients younger than 75 and 7% in patients 75 years or older.

Of the 167 patients with MIBC treated with KEYTRUDA in combination with enfortumab vedotin, 37% (n=61) were 65-74 years and 46% (n=77) were 75 years or older. Patients 75 years of age or older treated with KEYTRUDA in combination with enfortumab vedotin experienced a higher incidence of fatal adverse reactions than younger patients. The incidence of fatal adverse reactions was 4% in patients younger than 75 and 12% in patients 75 years or older.

Additional Selected KEYTRUDA Indications in the U.S.

Non-Small Cell Lung Cancer

KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.

KEYTRUDA, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of patients with metastatic squamous NSCLC.

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with NSCLC expressing PD-L1 [tumor proportion score (TPS) ≥1%] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, and is:

  • Stage III where patients are not candidates for surgical resection or definitive chemoradiation, or
  • metastatic.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS ≥1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA.

KEYTRUDA is indicated for the treatment of patients with resectable (tumors ≥4 cm or node positive) NSCLC in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery.

KEYTRUDA, as a single agent, is indicated as adjuvant treatment following resection and platinum-based chemotherapy for adult patients with Stage IB (T2a ≥4 cm), II, or IIIA NSCLC.

Malignant Pleural Mesothelioma

KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic malignant pleural mesothelioma (MPM).

Head and Neck Squamous Cell Cancer

KEYTRUDA is indicated for the treatment of adult patients with resectable locally advanced head and neck squamous cell carcinoma (HNSCC) whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-approved test, as a single agent as neoadjuvant treatment, continued as adjuvant treatment in combination with radiotherapy (RT) with or without cisplatin and then as a single agent.

KEYTRUDA, in combination with platinum and fluorouracil (FU), is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC.

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy

Classical Hodgkin Lymphoma

KEYTRUDA is indicated for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL).

KEYTRUDA is indicated for the treatment of pediatric patients with refractory cHL, or cHL that has relapsed after 2 or more lines of therapy.

Primary Mediastinal Large B-Cell Lymphoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy. KEYTRUDA is not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy.

Urothelial Cancer

KEYTRUDA, in combination with enfortumab vedotin, is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma:

  • who are not eligible for any platinum-containing chemotherapy, or
  • who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

KEYTRUDA, in combination with enfortumab vedotin, as neoadjuvant treatment and then continued after cystectomy as adjuvant treatment, is indicated for the treatment of adult patients with muscle invasive bladder cancer (MIBC) who are ineligible for cisplatin-containing chemotherapy.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.

Microsatellite Instability-High or Mismatch Repair Deficient Cancer

KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options.

Microsatellite Instability-High or Mismatch Repair Deficient Colorectal Cancer

KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC) as determined by an FDA-approved test.

Gastric Cancer

KEYTRUDA, in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test.

KEYTRUDA, in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS ≥ 1) as determined by an FDA approved test.

Esophageal Cancer

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic esophageal or gastroesophageal junction (GEJ) (tumors with epicenter 1 to 5 centimeters above the GEJ) carcinoma that is not amenable to surgical resection or definitive chemoradiation either:

  • in combination with platinum- and fluoropyrimidine-based chemotherapy for patients with tumors that express PD-L1 (CPS ≥1), or
  • as a single agent after one or more prior lines of systemic therapy for patients with tumors of squamous cell histology that express PD-L1 (CPS ≥10) as determined by an FDA-approved test.

Cervical Cancer

KEYTRUDA, in combination with chemoradiotherapy (CRT), is indicated for the treatment of patients with locally advanced cervical cancer involving the lower third of the vagina, with or without extension to pelvic sidewall, or hydronephrosis/non-functioning kidney, or spread to adjacent pelvic organs (FIGO 2014 Stage III-IVA).

KEYTRUDA, in combination with chemotherapy, with or without bevacizumab, is indicated for the treatment of patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test.

Hepatocellular Carcinoma

KEYTRUDA is indicated for the treatment of patients with hepatocellular carcinoma (HCC) secondary to hepatitis B who have received prior systemic therapy other than a PD-1/PD-L1-containing regimen.

Biliary Tract Cancer

KEYTRUDA, in combination with gemcitabine and cisplatin, is indicated for the treatment of patients with locally advanced unresectable or metastatic biliary tract cancer (BTC).

Merkel Cell Carcinoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC).

Renal Cell Carcinoma

KEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC).

KEYTRUDA is indicated for the adjuvant treatment of patients with RCC at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.

Endometrial Carcinoma

KEYTRUDA, in combination with carboplatin and paclitaxel, followed by KEYTRUDA as a single agent, is indicated for the treatment of adult patients with primary advanced or recurrent endometrial carcinoma.

KEYTRUDA, as a single agent, is indicated for the treatment of adult patients with advanced endometrial carcinoma that is MSI-H or dMMR, as determined by an FDA-approved test, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation.

Tumor Mutational Burden-High Cancer

KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [≥10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with TMB-H central nervous system cancers have not been established.

Cutaneous Squamous Cell Carcinoma

KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) or locally advanced cSCC that is not curable by surgery or radiation.

Triple-Negative Breast Cancer

KEYTRUDA is indicated for the treatment of patients with high-risk early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery.

KEYTRUDA, in combination with chemotherapy, is indicated for the treatment of patients with locally recurrent unresectable or metastatic TNBC whose tumors express PD-L1 (CPS ≥10) as determined by an FDA-approved test.

Ovarian Cancer

KEYTRUDA, in combination with paclitaxel, with or without bevacizumab, is indicated for the treatment of adult patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-authorized test, and who have received 1 or 2 prior systemic treatment regimens.

Merck’s focus on cancer

Every day, we follow the science as we work to discover innovations that can help patients, no matter what stage of cancer they have. As a leading oncology company, we are pursuing research where scientific opportunity and medical need converge, underpinned by our diverse pipeline of more than 25 novel mechanisms. With one of the largest clinical development programs across more than 30 tumor types, we strive to advance breakthrough science that will shape the future of oncology. By addressing barriers to clinical trial participation, screening and treatment, we work with urgency to reduce disparities and help ensure patients have access to high-quality cancer care. Our unwavering commitment is what will bring us closer to our goal of bringing life to more patients with cancer. For more information, visit https://www.merck.com/research/oncology/ .

About Merck’s research in melanoma

Merck is committed to delivering meaningful advances for patients with melanoma and to continuing research in skin cancers through a broad clinical development program across investigational and approved medicines. KEYTRUDA has been established as an important treatment option for the adjuvant treatment of patients with resected Stage IIB, IIC, or III melanoma based on results of KEYNOTE-054 and KEYNOTE-716. KEYTRUDA is also approved worldwide for the treatment of patients with unresectable or metastatic melanoma.

About Merck

At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.merck.com  and connect with us on  X (formerly Twitter) , Facebook , Instagram , YouTube and LinkedIn .

About Moderna

Moderna is a pioneer and leader in the field of mRNA medicine. Through the advancement of its technology platform, Moderna is reimagining how medicines are made to transform how we treat and prevent diseases. Since its founding, Moderna’s mRNA platform has enabled the development of vaccines and therapeutics across infectious diseases, cancer, rare diseases and more.

With a global team and a unique culture, driven by the company’s values and mindsets, Moderna’s mission is to deliver the greatest possible impact to people through mRNA medicines. For more information about Moderna, please visit modernatx.com and connect with us on X, Facebook, Instagram, YouTube and LinkedIn.

Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA

This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2025 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site ( www.sec.gov ).

Moderna Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding: the ability of intismeran autogene in combination with KEYTRUDA to demonstrate sustained improvement in RFS and DMFS compared with KEYTRUDA alone; the encouraging trend in overall survival compared with KEYTRUDA alone; the potential long-term benefit; the tolerability and safety profile for intismeran autogene; the companies’ ongoing Phase 2 and Phase 3 clinical trials, including anticipated milestones; and mRNA’s potential in cancer care. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna’s control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include, among others, those risks and uncertainties described under the heading “Risk Factors” in Moderna’s Annual Report on Form 10-K for the fiscal year ended December 31, 2025, and in subsequent filings made by Moderna with the U.S. Securities and Exchange Commission, which are available on the SEC’s website at www.sec.gov. Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna’s current expectations and speak only as of the date of this press release.

###

Please see Prescribing Information for KEYTRUDA (pembrolizumab) at https://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_pi.pdf and Medication Guide for KEYTRUDA at https://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_mg.pdf .

Merck Media Contacts:

Carly Myar

carly.myar@merck.com

Julie Cunningham

julie.cunningham@merck.com

Merck Investor Contacts:

Peter Dannenbaum

(732) 594-1579

Steven Graziano (732) 594-1583

Moderna Media Contacts:

Chris Ridley

Vice President, Global Head of Media Relations

+1 617-800-3651

Chris.Ridley@modernatx.com

Moderna Investor Contacts:

Lavina Talukdar

Senior Vice President & Head of Investor Relations

+1 617-209-5834

Lavina.Talukdar@modernatx.com

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Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA

This website of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2025 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site ( www.sec.gov ).

No Duty to Update

The information contained in this website was current as of the date presented. The company assumes no duty to update the information to reflect subsequent developments. Consequently, the company will not update the information contained in the website and investors should not rely upon the information as current or accurate after the presentation date.

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打开快讯原页

Jin10:Moderna 创逾一年最大单日跌幅

重要性2/5 低

快讯可确认价格跌幅,但没有给出经核实的单一事件原因,因此只进入事件雷达。

Moderna(MRNA)在 2026-07-10 美股交易日收跌约 11%,为 2025 年 5 月以来最大单日跌幅。

快讯原始事实

Moderna(MRNA)在 2026-07-10 美股交易日收跌约 11%,为 2025 年 5 月以来最大单日跌幅。

技术位置与分批建仓

标的7 月 10 日收盘12 日 RSI近期支持近期阻力当前动作
XLV$160.8468.4$156.99$161.91首轮只完成目标的 40%,不在阻力上方追满
XBI$159.0371.6$150.62$159.99首轮完成目标的 25%;等盘整或支持确认
JNJ$256.9866.3$251.08$259.027 月 15 日财报前只完成目标的一半
GILD$129.8358.7$128.93$130.48先买一半,等并购后资产负债表更新
ABBV$248.0864.5$247.56$252.597 月 31 日财报前只完成目标的一半
MRNA$68.2758.6$67.74;下一层约 $61.25$73.95FDA 决定前只投入 $400;跌破支持不自动补仓
SDGR$16.4961.8$16.30$16.52技术区间过窄,主要按财务和产品节点分批

技术数据使用 Yahoo Finance 日线和由小时线聚合的 4h K 线;本地 IB Gateway/TWS 当时没有开放可用连接,因此本报告明确采用公开图表源。支持、阻力和 RSI 是历史价格计算,不是可成交报价,也不替代基本面失效条件。

阶段合计投入XLVXBIJNJGILDABBVMRNASDGR执行条件
第一轮$36,000$17,600$3,750$5,000$5,000$4,000$400$250当前用 2-3 个交易日限价分散成交,不追突破日
第二轮最多 $25,000$13,200$3,750$2,500$2,500$2,000$600$4508 月 5 日后,财报、FDA 与现金指引没有触发失效条件
第三轮最多 $29,000$13,200$7,500$2,500$2,500$2,000$1,000$300出现支持区回撤并企稳,或下一次季度数据再次确认;按证据执行,不按日期强制买入
保留储备$10,000全程保留,直到组合进入下一次季度再平衡

若第二轮条件没有通过,未投入金额继续留在现金/T-Bill,不把日历到期当成买入信号。MRNA 7 月 10 日收跌约 10.83%,Jin10:Moderna 创逾一年最大单日跌幅确认跌幅,但没有给出经核实的单一原因;截至 7 月 11 日,公司 IR、SEC 与 FDA 未显示当日新的可验证负面事件。获利回吐或技术性波动只能作为待验证解释。

情景、反证与调整动作

情景可观察证据组合动作
基准路径大型药企维持 FCF 与指引;MRNA FDA 决策和现金指引未恶化;XBI 在高位盘整按三轮计划逐步完成目标;季度再平衡回到 72/18/10
技术平台兑现SDGR 披露 Bunsen 定价、付费客户或 ACV 加速;MRNA 后期项目获批并给出可验证商业需求直接 AI 总仓仍先维持 3%;只有新的收入/临床证据足以改变估值分母时才重做上限
高 Beta 失速XBI 跌破约 $150.62 后无法收回;MRNA 跌破约 $67.74并伴随监管或现金指引恶化停止第二、三轮;先判断基本面事件,再决定是否把未投入资金转入 XLV 或继续现金
现金流核心失效GILD 并购后杠杆显著高于预期;ABBV 交易融资压低股息覆盖;JNJ 法律损失或经营指引恶化暂停对应个股加仓,保留 XLV 行业仓;直接仓转回现金,等待正式报表
单股过度集中任一公司穿透权重超过 15%,或直接 AI 总仓超过 3%停止新增;季度再平衡时先减直接仓,不通过增加更多 ETF 掩盖集中度

这套方案最强的反对意见有三项。第一,JNJ、GILD、ABBV 已经在 XLV 中,再买个股会增加集中度。回应是把穿透权重写进上限:JNJ 约 14.7% 已接近天花板,直接仓只为主动提高现金流质量。第二,XBI 过去一年涨幅很高,当前 RSI 也偏热。回应是 15% 目标分三轮投入,首轮只有 3,750 美元。第三,MRNA 是用户点名的高 Beta 公司,但 2% 仓位看起来很小。回应是它一年年化波动约 69%、Q1 净亏损 13.4 亿美元,且 8 月 5 日前存在明确二元事件;2% 已足以让利好产生组合贡献,同时把错误成本限制在可恢复范围。

监控雷达

日期/频率事件或指标需要回答的问题触发动作
2026-07-15JNJ Q2 财报收入、MedTech、FCF、talc 与全年指引是否支持 10% 直接仓未通过则取消 JNJ 第二轮
2026-07-31ABBV 与 MRNA Q2 财报ABBV 交易融资与现金流;MRNA 年末现金 45-50 亿美元指引是否维持对应第二轮延后至数据确认
2026-08-05MRNA mRNA-1010 FDA 目标日期正式结论、标签、商业准入与安全性要求决定 MRNA 后续 $1,600 是否继续投入
2026-08-27GILD BIC/LEN PDUFA周服 HIV 方案的标签和商业化时间表更新 GILD 增长假设,不自动提高权重
每季SDGR software ACV、hosted 转换、Bunsen 采用软件需求是否加速,商业客户留存率是否恢复满足两项以上再讨论从 1%提高至 1.5%
每季RXRX 现金运营支出、股本、随机临床路径现金跑道是否仍到 2028 年初,是否出现更高等级临床证据只在替换 MRNA/SDGR 的 0.5%时考虑直接仓
每月/偏离 2 个百分点72/18/10 桶权重与 15% 单股穿透上限涨幅是否把高 Beta 或单股推过上限停止新增或季度再平衡

来源