Tulisokibart

Merck & Co., Inc. (MRK) Q3 2025 Earnings Call October 30, 2025 9:00 AM EDT Company Participants Peter Dannenbaum - Vice President of Investor RelationsRobert Davis - Chairman, President & CEOCaroline Litchfield - Executive VP & CFODean Li - Executive VP & President of Merck Research Laboratories Conference Call Participants Asad Haider - Goldman Sachs Group, Inc., Research DivisionGeoffrey Meacham - Citigroup Inc., Research DivisionAkash Tewari - Jefferies LLC, Research DivisionEvan Seigerman - BMO Capital Markets Equity ResearchDaina Graybosch - Leerink Partners LLC, Research DivisionChristopher Schott - JPMorgan Chase & Co, Research DivisionCarter Gould - Cantor Fitzgerald & Co., Research DivisionTerence Flynn - Morgan Stanley, Research DivisionUmer Raffat - Evercore ISI Institutional Equities, Research DivisionCourtney Breen - Sanford C. Bernstein & Co., LLC., Research DivisionVamil Divan - Guggenheim Securities, LLC, Research DivisionLuisa Hector - Joh. Berenberg, Gossler & Co. KG, Research DivisionAlexandria Hammond - Wolfe Research, LLC 主持人 欢迎参加来自美国新泽西州拉威（Rahway, New Jersey, U.S.A.）的默沙东公司（Merck & Co., Inc.）2025年第三季度销售与财报电话会议。[操作提示略] 本次电话会议正在录音。如果您有任何异议，现在可以挂断。 我现在把电话交给默沙东公司投资者关系高级副总裁彼得·丹嫩鲍姆先生。先生，请开始。 Peter Dannenbaum投资者关系副总裁 谢谢你，Julie，早上好，大家好。欢迎参加默沙东公司2025年第三季度财报电话会议。今天的发言人包括：董事长兼首席执行官罗伯特·戴维斯（Rob Davis）；首席财务官卡罗琳·利奇菲尔德（Caroline Litchfield）；以及默沙东研究实验室总裁李德恩博士（Dr. Dean Li）。 在开始之前，我想指出，我们的美国通用会计准则（GAAP）业绩中包含一些项目，例如并购相关费用、重组成本以及其他特定项目，我们已在非GAAP业绩中将其剔除。详细的调节表见我们的新闻稿。 同时提醒大家，今天我们可能会做出某些前瞻性声明（forward-looking statements），这些声明属于1995年《美国私人证券诉讼改革法案》（U.S. Private Securities Litigation Reform Act of 1995）中的安全港条款（safe harbor provision）范围。此类声明基于公司管理层当前的信念，并受到重大风险与不确定性影响。如果我们的基础假设被证明不准确，或不确定性发生，实际结果可能与这些声明存在重大差异。 我们的美国证券交易委员会（SEC）文件（包括2024年Form 10-K的Item 1A部分）中列示了可能导致实际结果与前瞻性声明不同的风险因素与警示说明。默沙东公司无义务公开更新任何前瞻性声明。 今天的会议将配合幻灯片展示。幻灯片、财报新闻稿、准备好的讲话稿及SEC文件均已发布在公司投资者关系网站上。 现在，请Rob发言。 Robert Davis董事长、总裁兼首席执行官 谢谢你，Peter。早上好，感谢大家参加今天的会议。我们继续通过领先科学的力量在全球范围内拯救和改善生命，取得了有意义的进展。我们正在通过创新药物与疫苗组合为患者和客户创造价值，同时也在为未来打下坚实基础，我们当前的研发管线是近年来最强、最深的之一。目前我们约有80项Ⅲ期临床试验正在进行，覆盖心肺疾病、免疫学、HIV、眼科以及肿瘤等多种治疗领域，未来一年将迎来重要数据读出。 我们正在投资20多个极具潜力的新产品上市机会，其中一些已启动。这些项目将重塑我们的商业组合，为2030年代中期带来超过500亿美元的收入潜力。我们仍将坚持以科学与价值为导向的审慎并购策略，以进一步强化我们庞大的研发管线。 第三季度中，我们持续成功执行战略，在研发管线推进、重大审批获批以及新产品上市方面取得显著成果。此外，10月我们完成了对维罗纳制药公司（Verona Pharma）的战略收购，这将为我们在下一个十年再添一项具有数十亿美元商业潜力的重要增长引擎。 公司各业务进展顺利，我对我们进一步扩大患者覆盖面、实现长期增长并为股东创造价值充满信心。 关于美国医疗政策，我此前已强调，我们与政府部门共享同一目标——降低美国患者在购买药品时的自付费用，同时促使那些尚未为我们的创新支付合理价值的国家提高药品支付水平。我们正积极与政府合作，努力找到一条既能实现这些目标，又能保障我们未来创新投资能力及公司长期可持续性的路径。对此我们持乐观态度。 我们也在美国本土制造方面进行重大投资。上周我们在弗吉尼亚州埃尔克顿（Elkton, Virginia）举行了奠基仪式，这是公司更广泛计划的一部分，将在未来投资超过700亿美元用于扩大本土制造与研发。这些投资将支持我们的长期增长计划，并巩固美国在全球生物制药创新中的领导地位。 来看第三季度业绩：公司整体表现稳健，肿瘤学与动物保健业务持续强劲，同时新产品WINREVAIR、CAPVAXIVE以及最新推出的ENFLONSIA贡献不断提升。 在研发方面，有几项值得注意的进展：在心血管领域，我们宣布了CORALreef Lipids试验的积极Ⅲ期顶线结果。这是评估口服PCSK9抑制剂enlicitide治疗高脂血症的第三项、也是规模最大的一项研究。我们将在下周美国心脏协会（AHA）会议上公布详细数据，并提交监管申报。 在肺动脉高压（PAH）方面，HYPERION研究的完整结果强化了我们对WINREVAIR临床改变潜力的信心。我们还获得了FDA批准的补充生物制品许可申请（sBLA），基于ZENITH试验的强劲结果。 在肿瘤学方面，我们很高兴FDA批准了皮下注射型帕博利珠单抗（pembrolizumab）即KEYTRUDA QLEX，欧洲药品管理局人用药品委员会（CHMP）也给予积极意见。KEYTRUDA QLEX可在一分钟内完成注射，为患者与医生提供重要新选择。我们持续不懈地推动更多肿瘤治疗方案的开发与交付。在ESMO会议上，我们展示了涵盖广泛肿瘤药物与候选药物的数据，包括获得突破性疗法认定的抗体偶联药物（ADC）的重要结果。 此外，我们持续扩大在免疫学领域的努力，其中另一款重要后期候选药物tulisokibart已在三种免疫介导炎症疾病中启动Ⅱb期试验。这些试验补充了其在系统性硬化症相关间质性肺病（SSc-ILD）的Ⅱ期研究，以及正在进行的溃疡性结肠炎（UC）和克罗恩病（CD）Ⅲ期试验。 我们欢迎来自维罗纳制药的新同事，并期待利用我们的商业能力与规模加速OHTUVAYRE的上市。这是一种创新的首创（first-in-class）慢性阻塞性肺疾病（COPD）维持治疗药物。 战略性业务开发依旧是首要任务。我们正紧迫评估潜在目标，希望在科学与价值契合时迅速出手。 总之，我们专注于在临床与商业上进一步巩固季度取得的强劲进展。我们为推进与扩展研发管线所做的投资，正不断转化为积极的临床结果与成功的新产品上市。这让我们更清晰地看到公司组合正向更具多元增长驱动的结构转型。每实现一个里程碑，包括具有战略意义的并购，我对公司开启下一阶段成功的信念便更为坚定。 我要感谢全球团队的奉献与努力。我相信我们将实现长期增长，并为患者与股东创造可持续价值。 现在交给Caroline。 Caroline Litchfield执行副总裁兼首席财务官 谢谢你，Rob。早上好。正如Rob所述，公司本季度表现稳健，增长动力来自肿瘤学与动物保健业务的持续强劲，以及多款新产品贡献的增加。这些结果再次证明我们以科学为导向的战略以及未来增长前景的坚实基础。我们有信心在短期内继续交出良好成绩，并将通过审慎投资于有潜力的科学项目，为患者、客户和股东创造长期价值。 现在来看第三季度财务表现：公司总营收为173亿美元，同比增长4%，按固定汇率（ex-FX）计算增长3%。以下收入评论均为不含汇率影响的口径。 在肿瘤领域，KEYTRUDA销售额增长8%至81亿美元，全球增长主要由转移性适应症的强劲需求与早期癌症中的强势渗透推动。尤其是女性相关肿瘤（宫颈癌、乳腺癌、子宫内膜癌）的使用增长显著。此外，KEYTRUDA与Padcev在局部晚期或转移性尿路上皮癌一线联合治疗的应用也有所上升。在美国，增长约有1亿美元来自发货日历多出一个星期二的因素，部分被渠道波动抵消。我们也对刚于季度末获得批准并上市的KEYTRUDA QLEX感到兴奋。 我们的更广义肿瘤组合同样保持强劲增长，WELIREG销售额增长41%至1.96亿美元，主要由其在美国用于既往治疗的晚期肾细胞癌患者中的使用增加，以及部分国际市场持续推广带动。 疫苗方面，GARDASIL销售额为17亿美元，同比下降25%。若不计中国，下降幅度为3%，主要因日本“追补接种”报销政策到期所致，部分被美国市场13%的增长所抵消，美国增长得益于提价与美国疾控中心（CDC）采购节奏变化。 肺炎球菌疫苗CAPVAXIVE销售额为2.44亿美元，主要由零售药房与非零售客户需求增长及季节性库存积累推动。我们期待进一步扩大该产品覆盖的成人人群。 VAXNEUVANCE销售下降7%，因日本市场出现竞争性推荐（competitive preferential recommendation），抵消了部分国际市场的增长。美国销售基本持平，竞争压力被CDC库存采购所抵消。 在RSV领域，ENFLONSIA销售额为7900万美元，反映了预期需求前的初步备货。我们期待帮助更多婴儿在其第一个RSV季节获得保护。 心血管领域，WINREVAIR继续保持强劲势头，全球销售额达3.6亿美元。在美国，约有1500名新患者获得处方，季度内共发放超过2.4万份处方，显示出对该疗法的持续强劲需求。本季度约有4000万美元的分销时序影响，但在10月已完全逆转。 正在进行的研究数据进一步强化了我们对稳步新增患者的预期。长期来看，我们预计不合并前列环素（prostacyclin）背景治疗的患者比例将逐步上升。 美国以外市场，我们也在积极推进审批与报销进程，包括日本的上市启动，目前开局良好。总体而言，我们期待为更多肺动脉高压患者带来积极影响。 动物保健业务同样表现强劲，销售增长7%。家畜业务增长14%，得益于所有物种需求增加以及销售时序因素；宠物业务下降3%，主要由于兽医就诊次数减少与寄生虫药竞争加剧，但部分被价格、供应改善及新品上市抵消。 下面我将介绍利润表（P&L）的其余部分，以下均为非GAAP口径。 毛利率为81.9%，同比上升1.4个百分点，主要得益于产品结构改善。运营费用为66亿美元。季度内包含3亿美元的并购相关支出，而去年同期为22亿美元。若剔除这些支出，运营费用保持稳定，反映了我们在早期与后期研发管线及关键增长驱动因素上的投入增加，被费用时序所抵消。其他费用为1.06亿美元。税率为13.4%，受益于若干一次性项目。综合下来，每股收益（EPS）为2.58美元。 现在看2025年非GAAP指引（包括维罗纳收购与Koselugo协议重组的影响）：我们预计全年营收在645亿至650亿美元之间，同比增长1%至2%，不计汇率约0.5%的负面影响（按10月中旬汇率）。 毛利率假设维持约82%，其中包含不到1亿美元的关税相关成本。运营费用预计在259亿至264亿美元之间。该指引未包含额外重大并购交易。其他费用预计在4亿至5亿美元之间。全年税率预期为14%至15%。 流通股数约25.1亿股。综合后，每股收益预期区间为8.93至8.98美元。与2024年相比，中值包含约0.15美元的汇率负面影响。此前指引中值为8.92美元，当前8.96美元的中值反映Koselugo协议重组带来0.09美元正面贡献，部分被维罗纳收购约0.04美元的负面影响抵消。 供建模参考：KEYTRUDA在美国第四季度的同比增长预计将受到约2亿美元的发货时序负面影响。ENFLONSIA在美国的初始采购符合预期，但大部分属于RSV季节前的库存备货。 最后，正如Rob所述，我们拥有近年来最强的研发管线。所有主要项目都在推进，我们对未来机会感到兴奋。如先前所言，我们将全力投资这些机会。展望2026年，预计运营费用增长将加速，主要因研发（R&D）与销售管理费用（SG&A）增加，以支持管线与新品上市，其中包括超过5亿美元的投资，用以最大化OHTUVAYRE的潜力。这将帮助我们持续推出创新药物与疫苗，改善患者生活，并推动公司增长。 资本分配方面，我们的策略保持不变。首要任务是投资业务以驱动短期与长期增长。我们将继续投资关键增长引擎与广泛的创新候选管线，这些项目都有潜力解决重大未满足医疗需求。我们将坚持分红政策并力争逐步提高分红。业务发展仍是高优先级，我们具备充足财务实力来推进科学驱动、增值性的并购。我们保持较高的股票回购节奏，预计全年约50亿美元。 总而言之，随着年末临近，我们对公司前景保持信心。全球市场对我们创新产品的需求强劲，多款新品上市进展令人鼓舞，研发管线表现出色。凭借持续创新投资与执行力，我们有能力在当下及未来持续为患者、客户与股东创造价值。 现在交给Dean。 Dean Li执行副总裁兼Merck研究实验室总裁 谢谢你，Caroline。大家早上好。第三季度我们在临床与监管方面取得了若干重要里程碑。我将先从肿瘤学更新开始，随后是疫苗与传染病、免疫学、眼科，最后介绍我们在心血管与呼吸系统项目的进展。结尾我会重点提示直到2026年上半年即将到来的关键事件。 我们的多元肿瘤产品组合持续推进。上个月，我们获得了FDA对KEYTRUDA QLEX注射剂用于帕博利珠单抗（pembrolizumab）皮下注射（subcutaneous administration）的批准。与静脉输注型KEYTRUDA相比，KEYTRUDA QLEX的给药时间显著缩短，在每3周给药一次的情况下，医疗服务提供者皮下注射最快可在1分钟内完成。它有望在医疗场景上提供灵活性，同时提升医疗系统的效率与可及性。我们也看到其在某些早期疾病患者中的使用机会。迄今为止，基于KEYTRUDA的治疗方案在早期治疗（earlier setting）已获得FDA对10项适应症的批准。 上个月，欧洲药品管理局（EMA）人用药品委员会（CHMP）也对KEYTRUDA皮下注射给药给出了积极意见。欧盟委员会已批准将KEYTRUDA作为围手术期（perioperative）方案的一部分，用于治疗某些可手术切除的、局部晚期头颈部鳞状细胞癌成年患者，此批准基于Ⅲ期KEYNOTE-689试验。 我们持续在多项适应症上、覆盖早期与转移性阶段，为KEYTRUDA构建广泛而扎实的证据体系。在欧洲肿瘤内科学会（ESMO）年会上，KEYTRUDA项目的数据在两个主席专题（Presidential Symposium）上展示。其中包括KEYNOTE-B96在某些铂类耐药复发性卵巢癌患者中的无进展生存期（PFS, progression-free survival）与总生存期（OS, overall survival）结果。FDA已受理我们的补充生物制品许可申请（sBLA）并纳入优先审评（priority review），处方药使用者付费法案（PDUFA）日期为2月20日。 同样在ESMO上，我们展示了KEYNOTE-905的无事件生存（EFS, event-free survival）与总生存数据。该研究纳入了因顺铂方案（cisplatin-based chemotherapy）不适用的肌层浸润性膀胱癌（MIBC, muscle-invasive bladder cancer）患者，并与安斯泰来与辉瑞（Astellas and Pfizer）合作开展。FDA也已将此项sBLA纳入优先审评，PDUFA日期为4月7日。 KEYTRUDA的成功使我们得以构建一个多元化的肿瘤研发管线。在ESMO上，我们还展示了不断扩大的抗体偶联药物（ADC, antibody-drug conjugate）候选组合的数据，包括：由合作方科伦（Kelun）开展的Ⅲ期OptiTROP-Lung04研究中，针对EGFR突变型非小细胞肺癌患者的TROP2靶向ADC——sac-TMT的结果。 此外，还有科伦开展的Ⅲ期OptiTROP-Breast02研究，评估sac-TMT在局部晚期或转移性激素受体阳性（HR-positive）、HER2阴性（HER2-negative）乳腺癌中的表现；以及我们与第一三共（Daiichi Sankyo）合作的Ⅱ/Ⅲ期REJOICE-Ovarian01研究，评估靶向CDH6的ADC——R-DXd在某些铂类耐药的卵巢癌、原发性腹膜癌或输卵管癌患者中的结果。 另外，本周早些时候，我们很高兴宣布首创（first-in-class）口服HIF-2α抑制剂（HIF-2 alpha inhibitor）WELIREG在辅助治疗与晚期肾细胞癌两方面取得积极结果，基于两项Ⅲ期试验：与KEYTRUDA联合的LITESPARK-022，以及与乐伐替尼（Lenvima）联合的LITESPARK-011（与卫材Eisai合作）。 接下来是疫苗与传染病。先说CAPVAXIVE，我们的21价肺炎球菌结合疫苗（21-valent pneumococcal conjugate vaccine）。在先前已获美国与欧盟批准的基础上，8月日本厚生劳动省（MHLW）也批准了CAPVAXIVE用于老年人与高风险成年群体的肺炎球菌感染预防。我们也在评估CAPVAXIVE在更多患者类型中的潜力。在欧洲临床微生物与传染病学会（ESCMID）疫苗会议上，我们展示了Ⅲ期STRIDE-13试验的结果，评估该疫苗在2至17岁、肺炎球菌疾病高风险的儿童与青少年中的安全性、耐受性与免疫原性（immunogenicity）。FDA已受理相关sBLA并设定PDUFA日期为6月18日。 关于RSV，自6月获批后，我们用于预防婴儿在进入或处于其第一个RSV季节时发生RSV疾病的长效单克隆抗体（long-acting monoclonal antibody）ENFLONSIA现已上市。本月早些时候，我们收到了来自EMA的CHMP积极意见。 转至HIV。我们在治疗与暴露前预防（PrEP）领域均有研发项目，核心是我们的研究性核苷（酸）逆转录酶转位抑制剂（NRTTI, nucleoside/nucleotide reverse transcriptase translocation inhibitor）islatravir与MK-8527。本月早些时候，在欧洲艾滋病大会（EACS）上公布了新的研究发现，包括：将多拉韦林（doravirine）与islatravir作为每日一次口服的双药方案，治疗病毒学已抑制且正在接受抗逆转录病毒治疗（ART）的成人HIV-1感染者的48周Ⅲ期数据；以及与吉利德（Gilead）合作进行的、将islatravir与来那卡帕韦（lenacapavir）作为每周一次口服联合治疗、用于病毒学已抑制成人HIV-1感染者的96周Ⅱ期结局数据。 接着是免疫学与眼科。Tulisokibart是一款人源化单克隆抗体，靶向与炎症与纤维化相关的TNF样细胞因子1A（tumor necrosis factor like cytokine 1A）。溃疡性结肠炎（UC）的Ⅲ期ATLAS试验近日完成入组；克罗恩病（CD）的Ⅲ期ARES试验进展顺利。在此基础上，我们近期宣布扩大tulisokibart在皮肤科与风湿科适应症的开发计划，已启动3项Ⅱb期试验。 自去年收购EyeBio以来，我们在推进MK-3000的Ⅲ期临床开发项目方面取得显著进展。MK-3000是一款针对特定视网膜疾病、靶向Wnt通路（Wnt pathways）的创新候选药物。糖尿病黄斑水肿（DME, diabetic macular edema）患者的Ⅲ期BRUNELLO研究已完成入组，研究的主要完成日期被提前至2026年9月。评估MK-3000用于新生血管性年龄相关性黄斑变性（nAMD, neovascular age-related macular degeneration）以及视网膜静脉阻塞（RVO, retinal vein occlusion）的Ⅱ期SUPER TUSCAN研究正在入组中。 此外，本月早些时候，在美国眼科学会（AAO）主办的Eyecelerator活动上，我们首次公布了RIOJA研究的Ⅰ期鼓舞性数据，评估我们的四价双特异性抗体（tetravalent bi-specific antibody）MK-8748，其同时靶向Tie2与VEGF，用于分支视网膜静脉阻塞继发性黄斑水肿与新生血管性AMD患者。基于这些数据，我们计划于2026年启动后期临床试验。 接下来是心血管与呼吸系统项目。WINREVAIR是首个也是唯一一个用于治疗成人肺动脉高压（PAH）的激活素信号通路抑制剂（activin signaling inhibitor），持续在广泛的PAH患者谱系中生成其获益证据。 在欧洲呼吸学会年会上展示了Ⅲ期HYPERION研究的结果，该研究纳入新近确诊的成年PAH患者。在背景治疗基础上加用WINREVAIR，与单纯背景治疗相比，可显著将临床恶化事件（clinical worsening events）的风险降低76%，尽管由于失去临床均衡（clinical equipoise）而提前终止研究。该结果亦已发表于《新英格兰医学杂志》（New England Journal of Medicine）。 FDA近期也基于Ⅲ期ZENITH试验结果，批准更新WINREVAIR的产品标签。随着适应症扩展，WINREVAIR成为首个在适应症描述中包含临床恶化事件构成要素——PAH住院、肺移植与死亡——的PAH治疗药物。 随着对Verona Pharma收购的完成，我们欢迎新的同事加入团队。共同努力下，我们有望在OHTUVAYRE的成功基础上再接再厉。OHTUVAYRE是一款首创的双重磷酸二酯酶3与4（PDE3/4）抑制剂（dual phosphodiesterase 3 and 4 inhibitor），用于慢性阻塞性肺疾病（COPD）的维持治疗。我们计划推进其在支气管扩张（bronchiectasis）中的在研工作，并评估其在更多适应症、联合疗法与替代剂型中的潜在用途。 尽管筛查与治疗不断进步，全球仍处在心血管疾病流行之中，动脉粥样硬化性心血管疾病（ASCVD）依旧是全球首要死亡原因。 今年9月，我们宣布研究性口服PCSK9抑制剂enlicitide在CORALreef Lipids研究中达到所有主要与关键次要终点，显示出在中高强度他汀治疗的成人高胆固醇血症患者，或已记录他汀不耐受（statin intolerance）的患者中，能实现统计学显著且具有临床意义的低密度脂蛋白胆固醇（LDL cholesterol）降低。这是enlicitide第三个阳性的Ⅲ期试验。我们期待在下周新奥尔良举行的美国心脏协会科学年会（AHA Scientific Sessions）上，报告CORALreef Lipids研究的详细结果，以及聚焦杂合子家族性高胆固醇血症（家族性杂合子高胆固醇血症，heterozygous familial hypercholesterolemia）的CORALreef研究结果。 请在日程上标注：AHA会议期间，我们将在11月9日星期天晚上举办一场投资者活动，届时将重点解读这些结果，并概览我们的心血管与呼吸系统项目。 我们的管线在各方面都保持强劲势头。正如Rob提到的，我们目前在多个治疗领域约有80项Ⅲ期试验正在开展。我们今年已启动超过15项Ⅲ期研究，并预计2026年会有更多。 展望到2026年上半年，我们预计将在多个治疗领域迎来一系列有节奏的里程碑，包括：在肿瘤学方面，基于KEYNOTE-B96针对某些铂类耐药复发性卵巢癌患者的PDUFA日期为2月20日；基于KEYNOTE-905针对某些更早期MIBC患者的PDUFA日期为4月7日。 在HIV方面：每日一次口服治疗方案——多拉韦林与islatravir联合的PDUFA日期为4月28日；以及ISLEND-1与-2这两项Ⅲ期试验的数据，评估islatravir与来那卡帕韦的每周一次口服联合治疗方案。 在免疫学方面：来自ATHENA研究的tulisokibart在系统性硬化症相关间质性肺病（SSc-ILD）中的Ⅱ期数据；在心肺领域：WINREVAIR用于左心疾病导致的肺高压（pulmonary hypertension due to left heart disease）的Ⅱ期CADENCE研究数据；enlicitide方面：来自CORALreef开发项目三项Ⅲ期试验的详细结果展示。 我们在多个治疗领域的多元化管线持续取得进展，期待在2026年为大家带来更多项目更新。 现在我把话筒交还给Peter。 Peter Dannenbaum投资者关系副总裁 谢谢你，Dean。Julie，我们现在进入答疑环节。[操作提示略] 谢谢。 问答环节 主持人 [操作提示略] 我们的第一个问题来自Goldman Sachs的Asad Haider。 Asad HaiderGoldman Sachs Group, Inc., Research Division 或许这个问题请Rob从BD（业务发展，business development）角度回答。你在准备稿中提到你们正在以紧迫感评估潜在标的，这让我感到放心。显然，你们对Verona的交易似乎获得了良好反馈，市场也希望看到你们进行更多类似的交易。所以，若能提供你们当前在“寻找什么”的最新框架会很有帮助。然后相关地，考虑到外部环境，业内关于可能重新出现具有变革性的更大型交易的讨论也在增加。能否分享你在这方面的最新看法？ Robert Davis董事长、总裁兼首席执行官 非常好，Asad，谢谢你的提问。谈到业务发展，正如你指出的，我们对与Verona的交易顺利完成感到非常兴奋。正如你所知，我们持续认为OHTUVAYRE具备数十亿美元级的机会，所以我们对这点感到振奋。但正如我们也说过的，这不是终点，我们确实还需要做更多。 我们持续在所有治疗领域中寻找机会。我会说，显然我们关注的领域与公司业务层面上的关键治疗领域保持一致。肿瘤学仍然存在大量机会，免疫学、心代谢（cardiometabolic）等也是我们持续关注的方向。像以往一样，科学会引领我们。当我们看到一个科学机会、存在未被满足的需求，且与我们的战略路径一致，只要我们认为有价值，我们就会行动。因此，我们的方法没有改变。 关于交易规模，我们仍将10亿美元到150亿美元区间作为主要关注范围。但正如我们此前明确表示的，我们也愿意做更大的交易，但始终以科学为核心，并始终明确，如果我们看到合适的机会，我们会基于那一未被满足的需求去做。 至于你更宏观的问题，即更大规模交易可能重新出现，我们的观点没有变化。我们不认为需要进行那种“变革性收购”、以协同效应为驱动的交易；这既不是我们必须做的，也不符合我们的未来方向，因为正如你所知，我们拥有公司历史上最强之一的研发管线，而我们认为大型、以协同为驱动的交易会干扰这项工作。因此，我们的重点将是引入管线资产，而不是这类交易。但在这之下，正如我们过去所说，我们对Ⅰ期到Ⅲ期任何阶段都持开放态度，如果能找到商业化机会（commercial opportunities）也会考虑。所以我们会在整个谱系范围内寻找。 Operator 我们的下一个问题来自花旗银行的Geoff Meacham。 Geoffrey MeachamCitigroup Inc., Research Division 我有一个关于管线的问题要问Dean。关于你们在TL1A免疫学（TL1A immunology）项目上的扩展开发，我的理解是围绕Prometheus交易，你们已经建立了一个广泛的开发计划。能否从作用机制（mechanism）角度谈谈你们刚刚宣布的适应症选择？另外，在免疫与炎症（I&I, immunology & inflammation）领域，你们还看好哪些额外的开发机会？ Dean Li执行副总裁兼Merck研究实验室总裁 非常感谢你的问题。我们最初的重点在胃肠（GI）领域，我们的目标是做第一个且最好的TL1A（first and best-in-class TL1A）。我们一直在谈论扩展，也一直在思考扩展，而这种扩展最近已通过在风湿病学与皮肤病学中的Ⅱb期研究得到“勾勒”。 问题在于，我们是否还能看到更多？我会一直保持开放态度。我认为，溃疡性结肠炎（ulcerative colitis）的Ⅲ期，尤其是克罗恩病（Crohn’s disease）的Ⅲ期，对我非常重要，不仅因为它们在GI领域，更因为在克罗恩病中有纤维化（fibrosis）的因素。另一个是系统性硬化症相关间质性肺病（SSc-ILD）的Ⅱ期。我需要看到这些数据，因为如果我在克罗恩病中看到了信号，那么你就会从“类似其他抗细胞因子（anti-cytokines）抑制炎症”这一层面，转而拥有针对纤维化的发力点（leverage）。这会引导我们下一步要做什么。 Operator 我们的下一个问题来自Jefferies的Akash Tewari。 Akash TewariJefferies LLC, Research Division 你们团队谈到过实体瘤的1.0与2.0策略，1.0是sac-TM3——抱歉，sac-TMT；2.0是将ADC与PD-1/VEGF联合。在ESMO上看起来，你们的TROP2在二线至少在趋势上给出了6–12个月的总生存（OS, overall survival）获益，这是PD-1/VEGF所见的三倍。那么，什么让你们更兴奋？是你们在TROP2上看到的信号，还是PD-1/VEGF这一类？此外，这对你们是否愿意用LaNova资产再开展一轮Ⅲ期联合试验的意愿有何影响？ Dean Li执行副总裁兼Merck研究实验室总裁 我应该先校准一下。我不认为我们曾按你提到的各“阶段”来表述。我们对TROP2、对sac-TMT极其兴奋，并且与科伦（Kelun）的合作非常高效。 我想强调的一点是，人们很容易说“这是个TROP2 ADC”，然后把所有TROP2 ADC都放在一个篮子里，仿佛它们没有差别。我认为最新数据提示这些药物之间可能存在差异。我们非常感兴趣地推进着15项Ⅲ期研究，其中有10项实际是在其他TROP2药物未曾涉足的领域。因此我们非常希望将sac-TMT在恰当的场景中推进，与免疫治疗（IO）或其他精准靶向（precision targeted）方案进行联合或并行。 关于PD-1/VEGF，我们同样有兴趣推进，观察数据如何演进，不仅是我们自己的数据，也包括外部世界的证据。这将帮助我们确定PD-1/VEGF相对PD-1应处于何处。但我还是要强调，我们对sac-TMT非常兴奋。我们展示了数据，科伦也展示了数据。你也指出了它的差异性。我们相信并渴望看到那些能够驱动结果的试验——不仅在中国患者人群，也在美国与全球范围内。 Operator 我们的下一个问题来自BMO Capital Markets的Evan Seigerman。 Evan SeigermanBMO Capital Markets Equity Research 我想谈谈ENFLONSIA在美国的上市。RSV季节将至，你们能否谈谈与竞争产品相比的初期反馈，以及在潜在渗透方面你们目前看到的情况？ Robert Davis董事长、总裁兼首席执行官 我先说几句，如果Caroline有补充也可以加入。总体而言，我们对ENFLONSIA目前的进展感觉良好。回顾上市进程，我要指出，尽管我们拿到了所有完整的批准，但确实比最初预期晚了几周。这确实带来影响，因为这让我们进入季节的时间点稍晚。正如Caroline在准备稿中指出的，有7500万——或者说7900万美元的初始备货，这主要来自“为儿童接种计划”（VFC, Vaccines for Children）的播种订单（seeding order），以及其他批发分销渠道的备货。 因此，站在当下、结合本季与明年的展望，我们仍然看到机会。我想强调ENFLONSIA的优势：无需按体重给药（no weight-based dosing），以及我们可以统筹考虑的整体疫苗合同组合（total contracted portfolio of vaccines）。这些我们已谈过的因素，让我们相信这将是一款非常重要的疫苗。展望2026年及以后，我们仍持同样观点。至于2025年余下时间的表现，我们拭目以待，但总体而言，考虑到我们启动的时间点，我们感觉不错。 Caroline Litchfield执行副总裁兼首席财务官 补充Rob的观点：第三季度我们完成了播种订单，预期会在第四季度被实际使用。客户反馈非常好，我们期待在本季产生影响，并在迈入2026年时产生更大的影响。 Operator 我们的下一个问题来自Leerink Partners的Daina Graybosch。 Daina GrayboschLeerink Partners LLC, Research Division 能否更新一下KEYTRUDA在早期治疗（early-stage）场景下的销售占比，以及已批准的10种肿瘤类型中，哪些在推动这部分收入？ Robert Davis董事长、总裁兼首席执行官 我先回答，Daina，然后Caroline也可以补充。回顾我们在早期治疗领域的布局，目前我们有10个已批准适应症，其中有5个已拿到总生存（OS）数据，这一点很重要。展望未来，推动因素包括宫颈癌仍然重要；肾细胞癌（RCC）也在推进；我们持续看到三阴乳腺癌（TNBC）和非小细胞肺癌（NSCLC）等同样是重要驱动。我们当然也很兴奋，尽管尚未获批，但你刚才听到，我们还有一个潜在的OS获益即将到来，应该是905，Dean之前谈到过，那是肌层浸润性膀胱癌。 所以有很多进展让我们期待。它正在驱动我们的增长——目前超过一半的增长来自早期适应症。回到之前，我们曾表示2024年早期占比将达到25%；而到了2025年，我们现在已经超过25%。我们没有给出具体目标，但我们看到早期占比还会继续提高，同时它贡献了超过一半的增长。所以它是关键驱动因素，尤其考虑到刚刚启动的QLEX上市。 Operator 我们的下一个问题来自JPMorgan的Chris Schott。 Christopher SchottJPMorgan Chase & Co, Research Division Rob，关于MFN（最惠国价，Most Favored Nation），我理解你们在准备稿中的表述。但考虑到近期政府与辉瑞、阿斯利康的交易，我们是否应该把这种架构视为行业的一个合理框架？以及，关于默沙东与你们在MFN方面与政府沟通的进展，有没有最新情况？ Robert Davis董事长、总裁兼首席执行官 Chris，谢谢你的问题。正如我在准备稿里所说，我们总体上与政府要实现的目标一致：在药房柜台降低患者自付（out-of-pocket）成本，同时推动海外价格上行，确保外国政府为药物创新支付合理份额。就这些总体原则而言，我们是一致的。我们正持续与政府沟通，我不打算给出具体更新，只能说我非常乐观，我们会在这些讨论上取得建设性的结果。至于具体框架，我们会等真正有内容可以公布时，再更明确地阐述我们的看法。 Operator 我们的下一个问题来自Cantor的Carter Gould。 Carter GouldCantor Fitzgerald & Co., Research Division 你们最近发布了两组不错的WELIREG数据。Dean，我想问你关于最终在022研究中拿到OS的信心，以及这对于推动该适应症采纳的重要性。 Dean Li执行副总裁兼Merck研究实验室总裁 我们对WELIREG同样感到兴奋。这是一款首创治疗（first-in-class）。我们已经宣布了二线治疗以及辅助治疗（adjuvant）的Ⅲ期顶线结果。我还认为，在其中一项试验里，HIF-2α（HIF-2 alpha）在VEGF阻断药物基础上的额外作用（do something on top of the VEGF blocking agent）也很重要。 关于OS，我认为OS始终非常重要。它对FDA重要，但最重要的是对患者重要。所以我们正热切期待，看看是否以及何时能跨过那道界限。是的，我们很兴奋，我们在WELIREG上有一个广泛的项目组合，一旦结果出来，我们也会迫不及待地进行分享。 Operator 我们的下一个问题来自Morgan Stanley的Terence Flynn。 Terence FlynnMorgan Stanley, Research Division Caroline，我知道你对2026年的费用做了一些评论。我想听听你对营收端的一些看法，理解你现在可能不想给出指引，但能否帮我们梳理一下可能的拉动与掣肘因素？ Caroline Litchfield执行副总裁兼首席财务官 当然可以，Terence。进入2026年，我们预期公司将实现稳健的营收增长，而这部分增长将越来越多地由我们的一系列新产品上市所驱动。我们预计WINREVAIR会带来持续的患者影响与营收增长；OHTUVAYRE现在也已纳入默沙东组合；CAPVAXIVE开局非常强劲；ENFLONSIA亦在其列。再加上我们的动物保健业务，增长同样将由新产品推动，包括12个月注射剂型的BRAVECTO QUANTUM，以及我们新的皮科产品NUMELVI。 我们同样预期肿瘤学将继续增长。延续上一个问题，WELIREG增长强劲，随着更多成功研究的到来、治疗更广泛患者，其潜力更大。我们也预期KEYTRUDA将继续增长，尽管增速会略低于以往，因为在某些适应症中我们正接近渗透率峰值，同时我们也预期海外市场会有一定价格逆风。 其他逆风将来自专利到期（LOE, loss of exclusivity）与仿制药进入。具体而言，DIFICID在2025年年中已在美国遭遇仿制药进入；BRIDION将在2026年年中面临LOE。此外，我们还预期《通胀削减法案》（IRA, Inflation Reduction Act）价格设定会对JANUVIA系列产生压力，且JANUVIA在明年年中将出现仿制药进入。总体上，我们有信心继续为患者带来积极影响并实现稳健增长。 Operator 我们的下一个问题来自Evercore的Umer Raffat。 Umer RaffatEvercore ISI Institutional Equities, Research Division 我在想是否该问下Organon的情况，不过那已经是多年前、且它已是独立公司，所以你们可能也没太多可说的。所以我转而问CADENCE试验。Dean，我的问题是，该试验在9月底完成。你们表示在2026年上半年。我觉得对一个150例的试验而言，这个时间比我预期的拿到读出要长一些。能否谈谈你们的考虑？ Dean Li执行副总裁兼Merck研究实验室总裁 正如大家所知，我们已有ZENITH、HYPERION这类更早期疾病阶段的数据。这些数据已经出来。CADENCE有一个今年的主要完成日期（primary completion date），我们说过会在一个会议上呈现这些数据。我相信，一旦我们拿到，也会发布顶线（top line）。因此，当我们谈到2026年第一季度或上半年时，我们指的是在医学会议上展示完整数据。 我们非常渴望看到该结果，因为它将告诉我们，在正式PAH人群之外（outside of the patient population that’s formally PAH），我们可以在多大程度上使用WINREVAIR。所以我们也同样期待这些结果。 Operator 我们的下一个问题来自Bernstein的Courtney Breen。 Courtney BreenSanford C. Bernstein & Co., LLC., Research Division 回到白宫价格政策压力以及你们先前的评论。我换个角度问：如果我们看默沙东当前的收入比例，大约是美国与海外各占50%。你们认为5年后会有多大变化？其中有多少是由产品结构（product mix）驱动？又有多少来自价格“趋同”（equalization of price）？ Robert Davis董事长、总裁兼首席执行官 Courtney，谢谢你的问题。我不会给出具体指引。显然，如果你看我们业务的驱动方向，我们对正在带来的多元管线感到兴奋。很多机会会相对更多地来自美国，主要是因为药物的属性、采纳速度以及你能在美国市场实现的价值。因此，结构（mix）将影响我们对未来的展望。至于MFN或其他定价动态的变化，还为时过早，因为我们需要先看到最终方案。因此目前我就先说到这里。 Operator 我们的下一个问题来自Guggenheim Securities的Vamil Divan。 Vamil DivanGuggenheim Securities, LLC, Research Division 感谢你们关于2026年的评论，帮助我们理解部分驱动因素。我有一个关于GARDASIL的问题。也许我们在此次电话会上没怎么谈GARDASIL是一件好事，但对这款产品而言，今年显然是具有挑战性的一年。我好奇你们如何看2026年及以后该产品在美国与海外的表现——美国这边，公众对疫苗的态度在变化，且指南（guidelines）可能会调整；海外则会“年化”冲淡中国与日本（追补人群）影响。市场一致预期认为未来数年该产品会重回强劲增长。你们怎么看？ Caroline Litchfield执行副总裁兼首席财务官 谢谢你的问题，Vamil。GARDASIL仍是一款非常重要的产品，我们也为其在帮助人们预防某些HPV相关癌症方面做出的影响感到自豪。展望未来，在美国，我们目前在9–10岁人群以及中年成人（mid-adult）人群的接种在增长，但这被青少年人群较低的水平所抵消，主要是由于目标人群规模下降，其中也有一些宏观因素。 展望美国，当然我们对增长持希望。但正如你所说，ACIP（免疫实践咨询委员会）关于给药方案（dosing schedule）的推荐将非常大程度上决定我们在美国是否增长。正如我们以往所说，我们会基于我们为社会提供的价值，在美国维持合适的定价水平。 美国以外，你说得对，我们将在2026年“跨过去”中国的影响，以及日本追补接种队列缩减的影响。我们期待在全球范围内保护更多人群。 在一些国家，公共项目已进入成熟期，因此我们预计每年都会为常规队列（routine cohort）进行接种。私营市场（private market）对我们而言是一个很好的增长机会，主要在27–45岁的中年成人人群。我们正在许多国家建立系统，帮助人们实现接种；另外在一些国家，我们也会在更广的年龄队列上发力。我们会逐步激活这些队列。这个过程需要时间，但会推动私营市场增长。总体而言，我们预期GARDASIL在近期实现温和增长。 Operator 我们的下一个问题来自Berenberg的Luisa Hector。 Luisa HectorJoh. Berenberg, Gossler & Co. KG, Research Division 回到KEYTRUDA。能否更新一下你们对从静脉（IV）转向皮下（SC, subcutaneous）的最新预期，以及这种转化的节奏？结合这一点，Caroline，你提到2026年KEYTRUDA增长会放缓——请确认这是指整个产品线，还是仅IV剂型？你们会分别披露销售吗？ Robert Davis董事长、总裁兼首席执行官 Luisa，我先说几句，然后Caroline再回答你最后一部分问题。关于QLEX（皮下剂型）的预期，正如我们所说，目前上市还早，但一切都在轨道上，没有变化。我们仍然预计能实现30%–40%的患者采用率（patient adoption），并且需要18–24个月才能达到这一水平，这一点没有改变。我也要强调，正如我们之前指出的，我们将获得永久J-code（医保结算编码），但可能要等6个月。在最初的6个月内，大家可以预期渗透会慢一些，因为使用临时J-code往往报销周期更长，因此一些机构会等拿到永久J-code后再下单。 我们尽可能从比我们更早推出皮下制剂的产品中吸取经验。我可以告诉你，我们制定并实施了商业合同策略（commercial contracting strategy），以尽量减少转换摩擦，使患者更容易从IV转向SC；对于新增患者，也能顺畅采用。这很重要，因为我们要驱动的是可及性与转化（access and conversion），这就是我们前进的目标。 我让Caroline来谈谈对明年整体增长的评论。 Caroline Litchfield执行副总裁兼首席财务官 是的，Luisa，我的评论是关于整个KEYTRUDA产品线（in its entirety）。我们预计KEYTRUDA将放缓，尽管它仍将是公司增长的重要贡献者。就像Rob所说，我们对QLEX的贡献非常期待。随着明年推进，我们将为越来越多患者提供治疗选择。 Peter Dannenbaum投资者关系副总裁 我们预计会在2026年起分别披露（报告）相关数据。 Operator 我们的最后一个问题来自Wolfe Research的Alex Hammond。 Alexandria HammondWolfe Research, LLC 关于EyeBio，你们能否把Ⅲ期BRUNELLO结果的预期“放在语境中”解读一下？试验成功的门槛是什么？考虑到该适应症竞争激烈，你们计划如何在商业方面执行？ Dean Li执行副总裁兼Merck研究实验室总裁 我先说，我们对推进这款首创（first-in-class）的MK-3000非常兴奋，它是一个靶向Wnt通路（Wnt pathway）的创新候选。我提醒一下，我认为这是第一次有一个新机制（novel mechanism）在具备明确人类遗传学证据（human genetic evidence）的基础上被推进。我们计划不仅在糖尿病黄斑水肿（DME）中评估MK-3000，也将在新生血管性年龄相关性黄斑变性（nAMD）中评估。 至于商业化执行，我会等看到试验数据后再谈。但我们推进得很快、很积极，因为这可能会成为首批新的作用机制之一——有点像WINREVAIR的故事——它是第一个真正新的机制，能够对如此广泛的疾病产生深远影响。 Robert Davis董事长、总裁兼首席执行官 我再补充一点商业机会。以美国为例，目前约有160万糖尿病黄斑水肿患者。这是糖尿病人群视力丧失的首要原因。所以在这类人群中，机会非常大，因为有30%–40%的在治患者对当前抗VEGF（anti-VEGF）并不响应（not responsive）。因此，潜在的“转换”（conversions）空间很可观。这个市场目前约130亿美元，我们相信凭借这一新分子实体（new molecular entity），我们有能力驱动这种转换。 在商业基础设施方面，我们正在结合EyeBio的领导力与我们在眼科的专业能力共同推进。我相当有信心，我们将具备推动这一项目的全球基础设施。我们在这上面投入很大。把这些与Tiespectus结合来看，这对公司而言是一个数十亿美元级机会。我们非常兴奋。我认为这是我们手中有些被低估的领域之一。我也要称赞Dean和团队，他们把这些项目推进的时间线比我们最初完成交易时预期的提前了几年。对我而言，这是一次胜利。 Peter Dannenbaum投资者关系副总裁 很好。谢谢你，Alex。也感谢各位的精彩提问，我们就到这里。若有后续问题，请联系投资者关系团队。 Operator 感谢各位的参与。各位参会者，现在可以挂线了。

Total Worldwide Sales Were $17.3 Billion, an Increase of 4% From Third Quarter 2024; Excluding the Impact of Foreign Exchange, Sales Grew 3% KEYTRUDA Sales Grew 10% to $8.1 Billion; Excluding the Impact of Foreign Exchange, Sales Grew 8% WINREVAIR Sales Were $360 Million; Growth of 141% Both Nominally and Excluding the Impact of Foreign Exchange CAPVAXIVE Sales Were $244 Million GARDASIL/GARDASIL 9 Sales Declined 24% to $1.7 Billion; Excluding the Impact of Foreign Exchange, Sales Declined 25% Animal Health Sales Grew 9% to $1.6 Billion; Excluding the Impact of Foreign Exchange, Sales Grew 7% KEYTRUDA Sales Grew 10% to $8.1 Billion; Excluding the Impact of Foreign Exchange, Sales Grew 8% WINREVAIR Sales Were $360 Million; Growth of 141% Both Nominally and Excluding the Impact of Foreign Exchange CAPVAXIVE Sales Were $244 Million GARDASIL/GARDASIL 9 Sales Declined 24% to $1.7 Billion; Excluding the Impact of Foreign Exchange, Sales Declined 25% Animal Health Sales Grew 9% to $1.6 Billion; Excluding the Impact of Foreign Exchange, Sales Grew 7% GAAP EPS Was $2.32; Non-GAAP EPS Was $2.58; GAAP and Non-GAAP EPS Include a Charge of $0.10 per Share for Milestone Payment to LaNova for Technology Transfer for MK-2010 Received FDA Approval of KEYTRUDA QLEX Injection for Subcutaneous Use Across All Solid Tumor Indications for KEYTRUDA Presented New Research Across More Than 20 Types of Cancer and Multiple Treatment Settings at ESMO Congress 2025, Including Positive Survival Data From KEYNOTE-905 and KEYNOTE-B96 Announced Positive Topline Results From Third Phase 3 CORALreef Lipids Trial of Enlicitide Decanoate for Treatment of Adults With Hypercholesterolemia Completed Acquisition of Verona Pharma and Its First-In-Class COPD Maintenance Treatment for Adults, OHTUVAYRE, in October Full-Year 2025 Financial Outlook Now Expects Worldwide Sales To Be Between $64.5 Billion and $65.0 Billion Raises and Narrows Expected Non-GAAP EPS Range To Be Between $8.93 and $8.98 Now Expects Worldwide Sales To Be Between $64.5 Billion and $65.0 Billion Raises and Narrows Expected Non-GAAP EPS Range To Be Between $8.93 and $8.98 RAHWAY, N.J.--(BUSINESS WIRE)--Merck & Co., Inc., Rahway, N.J., USA (NYSE: MRK), known as MSD outside the United States and Canada, today announced financial results for the third quarter of 2025. “In the third quarter, we continued to execute on our strategy with important pipeline advancements, significant approvals and successful new product launches,” said Robert M. Davis, chairman and chief executive officer. “We’re delivering value to patients and customers through our innovative portfolio of medicines and vaccines, and we’re securing our future by making important investments in our pipeline – including through compelling, strategic business development like our completed acquisition of Verona Pharma and expanded U.S. manufacturing and R&D spending. With each milestone we achieve, my conviction that we’re well-positioned to drive the next chapter of success for our Company increases.” Financial Summary Third Quarter $ in millions, except EPS amounts 2025 2024 Change Change Ex-Exchange Sales $17,276 $16,657 4% 3% GAAP net income1 5,785 3,157 83% 84% Non-GAAP net income that excludes certain items1,2* 6,448 3,985 62% 62% GAAP EPS 2.32 1.24 87% 88% Non-GAAP EPS that excludes certain items2* 2.58 1.57 64% 65% *Refer to table on page 7. For the third quarter of 2025, Generally Accepted Accounting Principles (GAAP) earnings per share (EPS) assuming dilution was $2.32 and non-GAAP EPS was $2.58. GAAP and non-GAAP EPS in the third quarter of 2025 include a charge of $0.10 per share for a milestone payment to LaNova Medicines Ltd. (LaNova, acquired by Sino Biopharmaceutical Limited) associated with the technology transfer for MK-2010. GAAP and non-GAAP EPS in the third quarter of 2024 include a net charge of $0.79 per share in the aggregate for the acquisition of Eyebiotech Limited (EyeBio) and a related development milestone, the acquisition of MK-1045 from Curon Biopharmaceutical (Curon), as well as a payment received from Daiichi Sankyo related to the expansion of the existing development and commercialization agreement to include gocatamig (MK-6070). Non-GAAP EPS in both periods excludes acquisition- and divestiture-related costs, costs related to restructuring programs, and income and losses from investments in equity securities. Non-GAAP EPS in the third quarter of 2025 also excludes tax expense relating to audit reserve adjustments. Year-to-date results can be found in the attached tables. Third-Quarter Sales Performance The following table reflects sales of the Company’s top products and significant performance drivers. Third Quarter $ in millions 2025 2024 Change Change Ex-Exchange Commentary Total Sales $17,276 $16,657 4% 3% Pharmaceutical 15,611 14,943 4% 3% Increase primarily driven by growth in oncology, cardiovascular and diabetes, partially offset by declines in vaccines, virology and immunology. KEYTRUDA 8,142 7,429 10% 8% Growth driven by continued strong global demand from metastatic indications, including urothelial, endometrial and gastric cancers, as well as robust global uptake in earlier-stage indications including triple-negative breast cancer, cervical cancer, renal cell carcinoma (RCC) and non-small cell lung cancer (NSCLC). Sales also benefitted from timing of wholesaler purchases in the U.S., partially offset by other channel movements. GARDASIL/GARDASIL 9 1,749 2,306 -24% -25% Decline primarily due to lower demand in China. Excluding China, sales declined 2%, or 3% excluding impact of foreign exchange, reflecting lower demand in Japan following a national catch-up immunization program, partially offset by higher sales in the U.S. due to higher net pricing and favorable public-sector purchasing patterns. PROQUAD, M-M-R II and VARIVAX 684 703 -3% -3% Decline primarily due to lower demand, partially offset by higher net pricing in the U.S. JANUVIA/JANUMET 624 482 29% 29% Growth driven by higher net pricing in the U.S., partially offset by lower demand in China as well as in most other international markets due to generic competition. BRIDION 439 420 5% 4% Growth primarily due to higher demand in the U.S., partially offset by lower demand in most international markets due to ongoing generic competition. Lynparza* 379 337 12% 12% Growth primarily due to higher demand in the U.S. and certain international markets. WINREVAIR 360 149 141% 141% Growth largely reflects continued uptake in the U.S., partially offset by timing of distributor purchases and lower net pricing in the U.S. largely due to Medicare Part D redesign. PREVYMIS 266 208 28% 25% Increase primarily due to higher demand in the U.S. and launch of new indications in certain international markets, partially offset by lower demand in China due to generic competition. Lenvima* 258 251 3% 2% Increase primarily due to higher sales in the U.S. reflecting higher demand, partially offset by lower net pricing. CAPVAXIVE 244 47 N/M N/M Represents continued uptake since third-quarter 2024 launch in the U.S., as well as expected seasonal inventory build. VAXNEUVANCE 226 239 -6% -7% Decline primarily due to lower demand in certain international markets, particularly in Japan due to competitive pressure, partially offset by higher demand in certain European markets. WELIREG 196 139 42% 41% Growth primarily driven by higher demand in the U.S. and continued launch uptake in certain European markets, partially offset by lower net pricing in the U.S. LAGEVRIO 138 383 -64% -65% Decline primarily due to lower demand in the Asia Pacific region, particularly in Japan, as well as in the U.S. SIMPONI - 189 -100% -100% Marketing rights in former territories of the Company reverted to Johnson & Johnson on Oct. 1, 2024. Animal Health 1,615 1,487 9% 7% Growth primarily due to performance of livestock products. Livestock 1,023 886 16% 14% Growth primarily driven by higher demand across all species, as well as timing of sales. Companion Animal 592 601 -2% -3% Decline primarily due to lower demand, reflecting a reduction in veterinary visits and competitive pressure for parasiticides, partially offset by higher pricing, improved supply and new product launches. Sales of BRAVECTO were $262 million and $266 million in current and prior-year quarters, respectively, which represents a decline of 1%, or 3% excluding impact of foreign exchange. Other Revenues** 50 227 -78% -27% Decline primarily due to unfavorable impact of revenue-hedging activities and lower revenue from third-party manufacturing arrangements. *Alliance revenue for this product represents the Company’s share of profits, which are product sales net of cost of sales and commercialization costs. **Other revenues are comprised primarily of revenues from third-party manufacturing arrangements and miscellaneous corporate revenues, including revenue-hedging activities. N/M- Not meaningful. In addition, Koselugo alliance revenue was $214 million in the third quarter of 2025 compared with $39 million in the third quarter of 2024. The increase was due to an amendment to the collaboration agreement with AstraZeneca, which discontinued the provisions whereby the Company shared revenue and costs with AstraZeneca, and revised the payment structure, resulting in the Company’s recognition of a $150 million upfront payment and a $50 million regulatory milestone. Third-Quarter Expense, EPS and Related Information The table below presents selected expense information. $ in millions GAAP Acquisition- and Divestiture- Related Costs3 Restructuring Costs (Income) Loss From Investments in Equity Securities Non-GAAP2 Third Quarter 2025 Cost of sales $3,855 $621 $110 $- $3,124 Selling, general and administrative 2,633 34 - - 2,599 Research and development 4,234 4 233 - 3,997 Restructuring costs 47 - 47 - - Other (income) expense, net (238) - - (344) 106 Third Quarter 2024 Cost of sales $4,080 $639 $192 $- $3,249 Selling, general and administrative 2,731 43 31 - 2,657 Research and development 5,862 24 - - 5,838 Restructuring costs 56 - 56 - - Other (income) expense, net (162) (27) - 58 (193) GAAP Expense, EPS and Related Information Gross margin was 77.7% for the third quarter of 2025 compared with 75.5% for the third quarter of 2024. The increase was primarily due to the favorable impact of product mix and lower restructuring costs, partially offset by higher inventory write-offs and the unfavorable impact of foreign exchange. Selling, general and administrative (SG&A) expenses were $2.6 billion in the third quarter of 2025, a decrease of 4% compared with the third quarter of 2024. The decrease was primarily due to lower administrative, restructuring and selling costs, partially offset by the unfavorable impact of foreign exchange. Research and development (R&D) expenses were $4.2 billion in the third quarter of 2025, a decrease of 28% compared with the third quarter of 2024. The decrease was primarily due to lower charges for business development activity, including charges of $2.2 billion in the aggregate related to the acquisitions of EyeBio and MK-1045 in the third quarter of 2024, compared with a charge of $300 million in the third quarter of 2025 related to a milestone payment to LaNova for the completion of the technology transfer for MK-2010. Excluding these charges, R&D expenses increased primarily due to higher restructuring costs and clinical development spending. Other (income) expense, net, was $238 million of income in the third quarter of 2025 compared with $162 million of income in the third quarter of 2024. The favorability was primarily due to net income from investments in equity securities in 2025 compared with net losses from investments in equity securities in 2024, partially offset by $170 million of income recognized in 2024 related to a payment received from Daiichi Sankyo associated with the expansion of an existing development and commercialization agreement to include gocatamig (MK-6070). The effective tax rate was 14.2% for the third quarter of 2025. GAAP EPS was $2.32 for the third quarter of 2025 compared with $1.24 for the third quarter of 2024. The increase was primarily driven by a net charge of $0.79 per share in the aggregate in 2024 for the EyeBio, Curon and Daiichi Sankyo transactions, partially offset by a charge of $0.10 per share in 2025 related to the LaNova technology transfer milestone payment. Non-GAAP Expense, EPS and Related Information Non-GAAP gross margin was 81.9% for the third quarter of 2025 compared with 80.5% for the third quarter of 2024. The increase was primarily due to the favorable impact of product mix, partially offset by higher inventory write-offs and the unfavorable impact of foreign exchange. Non-GAAP SG&A expenses were $2.6 billion in the third quarter of 2025, a decrease of 2% compared with the third quarter of 2024. The decrease was primarily due to lower administrative and selling costs, partially offset by the unfavorable impact of foreign exchange. Non-GAAP R&D expenses were $4.0 billion in the third quarter of 2025, a decrease of 32% compared with the third quarter of 2024. The decrease was primarily due to lower charges for business development activity, including charges of $2.2 billion in the aggregate related to the acquisitions of EyeBio and MK-1045 in the third quarter of 2024, compared with a charge of $300 million in the third quarter of 2025 related to a milestone payment to LaNova for the completion of the technology transfer for MK-2010. Excluding these charges, R&D expenses increased primarily due to higher clinical development spending. Non-GAAP other (income) expense, net, was $106 million of expense in the third quarter of 2025 compared with $193 million of income in the third quarter of 2024. The unfavorability was primarily due to $170 million of income recognized in 2024 related to a payment received from Daiichi Sankyo associated with the expansion of an existing development and commercialization agreement to include gocatamig (MK-6070). The non-GAAP effective tax rate was 13.4% for the third quarter of 2025. Non-GAAP EPS was $2.58 for the third quarter of 2025 compared with $1.57 for the third quarter of 2024. The increase was primarily driven by a net charge of $0.79 per share in the aggregate in 2024 for the EyeBio, Curon and Daiichi Sankyo transactions, partially offset by a charge of $0.10 per share in 2025 related to the LaNova technology transfer milestone payment. A reconciliation of GAAP to non-GAAP net income and EPS is provided in the table that follows. Third Quarter $ in millions, except EPS amounts 2025 2024 EPS GAAP EPS $2.32 $1.24 Difference 0.26 0.33 Non-GAAP EPS that excludes items listed below2 $2.58 $1.57 Net Income GAAP net income1 $5,785 $3,157 Difference 663 828 Non-GAAP net income that excludes items listed below1,2 $6,448 $3,985 Excluded Items: Acquisition- and divestiture-related costs3 $659 $679 Restructuring costs 390 279 (Income) loss from investments in equity securities (344) 58 Decrease to net income before taxes 705 1,016 Estimated income tax (benefit) expense4 (42) (188) Decrease to net income $663 $828 Pipeline and Portfolio Highlights In the third quarter, the Company continued to demonstrate pipeline progress with the achievement of key regulatory and clinical milestones. In oncology, in September 2025, the U.S. Food and Drug Administration (FDA) approved KEYTRUDA QLEX injection for subcutaneous (SC) administration for use in adults across most solid tumor indications for KEYTRUDA, based on results from the Phase 3 MK-3475A-D77 trial. In October 2025, the FDA subsequently approved KEYTRUDA QLEX for the treatment of certain adult patients with resectable locally advanced head and neck squamous cell carcinoma (LA-HNSCC), based on results from the Phase 3 KEYNOTE-689 trial. KEYTRUDA QLEX is now approved for use in adults across all solid tumor indications approved for KEYTRUDA and is the first and only subcutaneously administered immune checkpoint inhibitor that can be given by a health care provider in as little as one minute. In addition, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending approval for SC administration of KEYTRUDA for all adult indications; a final decision is expected in the fourth quarter of 2025. The European Commission (EC) also approved KEYTRUDA as part of a perioperative regimen for the treatment of PD-L1+ resectable LA-HNSCC. At the European Society for Medical Oncology (ESMO) Congress 2025, the Company announced new research from its broad and differentiated portfolio and pipeline, highlighting progress in new tumor types and earlier stages of disease. This included positive results from the Phase 3 KEYNOTE-905 trial (also known as EV-303) in cisplatin-ineligible patients with muscle-invasive bladder cancer (MIBC), the Phase 3 KEYNOTE-B96 trial in platinum-resistant recurrent ovarian cancer and the Phase 2/3 REJOICE-Ovarian01 trial in collaboration with Daiichi Sankyo in certain types of platinum-resistant ovarian cancer, long-term follow-up data from the Phase 3 KEYNOTE-775 trial in advanced endometrial cancer, as well as long-term data for KEYTRUDA in both earlier-stage and metastatic NSCLC. In vaccines and infectious diseases, in August 2025, the Company received two approvals in Japan: its nine-valent HPV vaccine for use in males ages 9 and older that will be marketed under the trademark SILGARD 9, and CAPVAXIVE for use in the elderly or adults who are at an increased risk of pneumococcal disease. At the European AIDS Clinical Society 2025 conference, the Company also presented new data from Phase 3 trials evaluating the once-daily, oral, two-drug regimen of doravirine/islatravir in adults with virologically suppressed HIV-1 infection, which showed minimal changes in weight and body composition and no clinically meaningful effect on fasting lipids and the homeostatic model assessment of insulin resistance across both clinical trials. In cardiovascular disease, the Company announced positive topline results from the Phase 3 CORALreef Lipids trial evaluating the safety and efficacy of enlicitide decanoate, an investigational, once-daily oral proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor being evaluated for the treatment of adults with hypercholesterolemia. The trial met all primary and key secondary endpoints. Enlicitide has the potential to be the first approved oral PCSK9 inhibitor. In addition, the FDA approved an update to the U.S. product label for WINREVAIR, based on results from the Phase 3 ZENITH trial, expanding the indication to include components of the clinical worsening events: hospitalization for pulmonary arterial hypertension (PAH), lung transplantation and death. Further, at the 2025 European Respiratory Society Congress, the Company presented positive results from the Phase 3 HYPERION trial evaluating WINREVAIR versus placebo (both in combination with background therapy) in adults recently diagnosed with PAH (Group 1 pulmonary hypertension) with World Health Organization (WHO) functional class II or III at intermediate or high risk of disease progression. Results showed that adding WINREVAIR within the first year after PAH diagnosis significantly reduced the risk of clinical worsening events compared to placebo. The Company also completed its acquisition of Verona Pharma plc (Verona Pharma) in October 2025, strengthening its cardio-pulmonary portfolio with the addition of OHTUVAYRE, an FDA-approved, first-in-class maintenance treatment for chronic obstructive pulmonary disease (COPD) in adult patients. Notable recent news releases on the Company’s pipeline and portfolio are provided in the table that follows. Visit the News Releases section of the Company’s website to read the releases.* Oncology FDA Approved KEYTRUDA QLEX Injection for SC Use in Adults Across Most Solid Tumor Indications for KEYTRUDA; Based on Results From Phase 3 MK-3475A-D77 Trial FDA Granted Breakthrough Therapy Designation for Raludotatug Deruxtecan (R-DXd) for Patients With CDH6 Expressing Platinum-Resistant Ovarian, Primary Peritoneal, or Fallopian Tube Cancers Previously Treated With Bevacizumab; Based on Results From Phase 1 Trial and REJOICE-Ovarian01 Phase 2/3 Trial FDA Granted Breakthrough Therapy Designation for Ifinatamab Deruxtecan (I-DXd) for Patients With Pretreated Extensive-Stage Small Cell Lung Cancer; Based on Results From Phase 2 IDeate-Lung01 Trial FDA Granted Priority Review for KEYTRUDA and KEYTRUDA QLEX, Each in Combination With Padcev, for Certain Patients With MIBC; FDA Set Prescription Drug User Fee Act (PDUFA) Date of April 7, 2026 EC Approved KEYTRUDA as Part of a Treatment Regimen for Adults With Resectable LA-HNSCC Expressing PD-L1 (CPS≥1); Based on Results From Phase 3 KEYNOTE-689 Trial EU CHMP Adopted Two Positive Opinions for KEYTRUDA, for SC Administration and for New Indication for Earlier-Stage Head and Neck Cancer; Latter Based on Results From Phase 3 KEYNOTE-689 Trial KEYTRUDA Plus Padcev Reduced Risk of Event-Free Survival Events by 60% and Risk of Death by 50% for Certain Patients With MIBC When Given Before and After Surgery; Based on Results From Phase 3 KEYNOTE-905 Trial KEYTRUDA Plus Chemotherapy, With or Without Bevacizumab, Reduced Risk of Disease Progression or Death Versus Chemotherapy, With or Without Bevacizumab, in Certain Patients With Platinum-Resistant Recurrent Ovarian Cancer; Based on Results From Phase 3 KEYNOTE-B96 Trial; FDA Set PDUFA Date of Feb. 20, 2026 Phase 3 KEYNOTE-B96 Trial Met Secondary Endpoint of Overall Survival in All Comers Population of Patients With Platinum-Resistant Recurrent Ovarian Cancer R-DXd Demonstrated Clinically Meaningful Response Rates in Patients With Recurrent Platinum-Resistant Ovarian, Primary Peritoneal or Fallopian Tube Cancer in Phase 2 Part of REJOICE-Ovarian01 Phase 2/3 Trial KEYTRUDA Demonstrated Long-Term Survival Benefit in Certain Patients With Earlier or Advanced Stages of NSCLC; Based on Exploratory Five-Year Analyses of Phase 3 KEYNOTE-671 Trial, Eight-Year Analyses of Phase 3 KEYNOTE-024 and KEYNOTE-042 Trials, and 10-Year Analyses of Phase 1b KEYNOTE-001 and Phase 2/3 KEYNOTE-010 Trials KEYTRUDA Plus Lenvima Demonstrated Durable Five-Year Survival Benefit Versus Chemotherapy for Patients With Advanced Endometrial Carcinoma Following One Prior Platinum-Based Regimen; Based on Results From Phase 3 KEYNOTE-775 Trial WELIREG Plus Lenvima Met Primary Endpoint of Progression-Free Survival in Certain Previously Treated Patients With Advanced RCC; Based on Results From Phase 3 LITESPARK-011 Trial KEYTRUDA Plus WELIREG Met Primary Endpoint of Disease-Free Survival in Certain Patients With Clear Cell RCC Following Nephrectomy; Based on Results From Phase 3 LITESPARK-022 Trial I-DXd Demonstrated Clinically Meaningful Response Rates in Patients With Extensive-Stage Small Cell Lung Cancer in IDeate-Lung01 Phase 2 Trial HERTHENA-Breast04 Phase 3 Trial of Patritumab Deruxtecan (HER3-DXd) Initiated in Patients With Metastatic Hormone Receptor-Positive, HER2-Negative Breast Cancer Previously Treated With Endocrine Therapy Vaccines and Infectious Diseases CAPVAXIVE Demonstrated Positive Immune Responses in Children and Adolescents at Increased Risk of Pneumococcal Disease; Based on Results From Phase 3 STRIDE-13 Trial The Company Announced New Data From Phase 3 Trials Evaluating the Investigational, Once-Daily, Oral, Two-Drug Regimen of Doravirine/Islatravir in Adults With Suppressed HIV-1 Infection; Based on Results From Phase 3 MK-8591A-051 and MK-8591A-052 Trials Systematic Review of 15 Studies Focused on Epidemiology and Antimicrobial Resistance of Pneumococcal Serotypes Covered by CAPVAXIVE in U.S. Adults Cardiovascular FDA Approved Updated Indication for WINREVAIR in Adults With PAH Based on Phase 3 ZENITH Study WINREVAIR Reduced the Risk of Clinical Worsening Events by 76% Compared to Placebo in Patients Recently Diagnosed With PAH on Background Therapy in Phase 3 HYPERION Trial Oral PCSK9 Inhibitor Enlicitide Decanoate Met All Primary and Key Secondary Endpoints in Adults With Hypercholesterolemia in Pivotal Phase 3 CORALreef Lipids Study Immunology The Company Expanded Tulisokibart Clinical Development Program With Initiation of Phase 2b Trials in Three Additional Immune-Mediated Inflammatory Diseases *References to the Company’s name in the above news release titles have been modified for the purpose of this announcement. Manufacturing and R&D Investment The Company continued to make long-term investments in its U.S. manufacturing and R&D capabilities and broke ground on a new $3 billion Center of Excellence for Pharmaceutical Manufacturing at its Elkton, Virginia site. The 400,000-square-foot facility will include both active pharmaceutical ingredient and drug product investment to support small molecule manufacturing and testing, creating more than 500 full-time jobs. This investment is part of the Company’s commitment to dedicate more than $70 billion beginning in 2025 to expand domestic manufacturing and R&D — not including any future business development in R&D — to drive its long-term growth and strengthen the U.S. as a global leader in biopharmaceutical innovation. Upcoming Investor Event The Company also plans to present new data from its innovative cardiovascular pipeline and portfolio at the American Heart Association (AHA) Scientific Sessions 2025 from Nov. 7-10. The Company will host an Investor Event to coincide with the AHA Scientific Sessions 2025 on Sunday, Nov. 9 at 6 p.m. CT. The event will take place in New Orleans and will be accessible via live audio webcast at this weblink. Sustainability Highlights The Company’s 2024/2025 Purpose for Progress Impact Report provided a comprehensive view of how it is pursuing innovative science for the health of people and animals and ensuring its efforts drive significant and sustainable value. The report noted that the Company’s medicines and vaccines reached more than 450 million people around the world in 2024. Full-Year 2025 Financial Outlook The following table summarizes the Company’s full-year financial outlook. Full Year 2025 Updated Prior Sales* $64.5 billion to $65.0 billion $64.3 billion to $65.3 billion Non-GAAP Gross margin2 Approximately 82% Approximately 82% Non-GAAP Operating expenses2(a) $25.9 billion to $26.4 billion $25.6 billion to $26.4 billion Non-GAAP Other (income) expenses, net2 $400 million to $500 million expense $300 million to $400 million expense Non-GAAP Effective tax rate2 14.0% to 15.0% 15.0% to 16.0% Non-GAAP EPS2(b)(c) $8.93 to $8.98 $8.87 to $8.97 Share count (assuming dilution) Approximately 2.51 billion Approximately 2.51 billion *The Company does not have any non-GAAP adjustments to sales. (a)Includes one-time R&D charges of $300 million for a milestone payment to LaNova associated with the technology transfer for MK-2010 and $200 million for an upfront payment for a license agreement with Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Hengrui Pharma). Outlook does not assume any additional significant potential business development transactions. (b)Includes one-time charges totaling $0.16 per share associated with the payment for the LaNova technology transfer for MK-2010 and the upfront payment to Hengrui Pharma. (c)Updated full-year 2025 outlook reflects a benefit of approximately $0.09 per share resulting from an amendment to the collaboration agreement with AstraZeneca related to Koselugo, and an estimated negative impact of $0.04 per share related to the acquisition of Verona Pharma. The Company has not provided a reconciliation of forward-looking non-GAAP gross margin, non-GAAP operating expenses, non-GAAP other (income) expense, net, non-GAAP effective tax rate and non-GAAP EPS to the most directly comparable GAAP measures, given it cannot predict with reasonable certainty the amounts necessary for such a reconciliation, including intangible asset impairment charges, legal settlements, and income and losses from investments in equity securities either owned directly or through ownership interests in investment funds, without unreasonable effort. These items are inherently difficult to forecast and could have a significant impact on the Company’s future GAAP results. The Company now expects full-year 2025 sales to be between $64.5 billion and $65.0 billion, including a negative impact of foreign exchange of approximately 0.5% at mid-October 2025 exchange rates. The Company now expects its full-year non-GAAP effective income tax rate to be between 14.0% and 15.0%. The Company now expects its full-year non-GAAP EPS to be between $8.93 and $8.98, including a negative impact of foreign exchange of approximately $0.15 per share. This revised non-GAAP EPS outlook reflects several items not previously included, such as a benefit from an amended collaboration agreement with AstraZeneca related to Koselugo, and operational improvements, including a more favorable estimated tax rate and lower estimated costs related to the impact of tariffs, partially offset by an estimated negative impact related to the acquisition of Verona Pharma and an incremental negative impact from foreign exchange. The midpoint of this revised non-GAAP EPS range reflects a net improvement of $0.04 per share compared to the midpoint of the Company’s prior outlook. As previously communicated, the revised estimated full-year 2025 non-GAAP EPS range reflects the impacts of the one-time charges in connection with a license agreement with Hengrui Pharma and the completion of the technology transfer with LaNova for MK-2010, which impact EPS by approximately $0.16 in the aggregate. In 2024, non-GAAP EPS of $7.65 was negatively impacted by a net charge of $1.28 per share related to certain asset acquisitions, licensing agreements and collaborations. Consistent with past practice, the financial outlook does not assume additional significant potential business development transactions. Earnings Conference Call Investors, journalists and the general public may access a live audio webcast of the call on Thursday, Oct. 30, at 9 a.m. ET via this weblink. A replay of the webcast, along with the sales and earnings news release, supplemental financial disclosures and slides highlighting the results, will be available on the Company’s website. All participants may join the call by dialing (800) 369-3351 (U.S. and Canada Toll-Free) or (517) 308-9448 and using the access code 9818590. About Our Company At Merck & Co., Inc., Rahway, N.J., USA, 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. 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, 2024 and the Company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov). Appendix Generic product names are provided below. Pharmaceutical BRIDION (sugammadex) CAPVAXIVE (Pneumococcal 21-valent Conjugate Vaccine) GARDASIL (Human Papillomavirus Quadrivalent [Types 6, 11, 16 and 18] Vaccine, Recombinant) GARDASIL 9 (Human Papillomavirus 9-valent Vaccine, Recombinant) JANUMET (sitagliptin and metformin HCl) JANUVIA (sitagliptin) KEYTRUDA (pembrolizumab) KEYTRUDA QLEX (pembrolizumab and berahyaluronidase alfa-pmph) Koselugo (selumetinib) LAGEVRIO (molnupiravir) Lenvima (lenvatinib) Lynparza (olaparib) M-M-R II (Measles, Mumps and Rubella Virus Vaccine Live) OHTUVAYRE (ensifentrine) PREVYMIS (letermovir) PROQUAD (Measles, Mumps, Rubella and Varicella Virus Vaccine Live) SIMPONI (golimumab) VARIVAX (Varicella Virus Vaccine Live) VAXNEUVANCE (Pneumococcal 15-valent Conjugate Vaccine) WELIREG (belzutifan) WINREVAIR (sotatercept-csrk) Animal Health BRAVECTO (fluralaner) 1 Net income attributable to the Company. 2 The Company is providing certain 2025 and 2024 non-GAAP information that excludes certain items because of the nature of these items and the impact they have on the analysis of underlying business performance and trends. Management believes that providing this information enhances investors’ understanding of the Company’s results because management uses non-GAAP results to assess performance. 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. This information should be considered in addition to, but not as a substitute for or superior to, information prepared in accordance with GAAP. For a description of the non-GAAP adjustments, see Table 2a attached to this release. 3 Reflects expenses related to business combinations, including the amortization of intangible assets, intangible asset impairment charges, and expense or income related to changes in the estimated fair value measurement of liabilities for contingent consideration. Also includes integration, transaction and certain other costs associated with acquisitions and divestitures, as well as amortization of intangible assets related to collaborations and licensing arrangements. 4 Includes the estimated tax impacts on the reconciling items based on applying the statutory rate of the originating territory of the non-GAAP adjustments for both periods presented. Amount in the third quarter of 2025 also includes $86 million of tax expense relating to audit reserve adjustments. GAAP % Change GAAP % Change 3Q25 3Q24 Sep YTD 2025 Sep YTD 2024 $ 17,276 $ 16,657 4% $ 48,611 $ 48,544 0% 3,855 4,080 -6% 10,831 11,365 -5% 2,633 2,731 -4% 7,835 7,952 -1% 4,234 5,862 -28% 11,903 13,354 -11% 47 56 -16% 676 258 * (238 ) (162 ) 47% (281 ) (151 ) 86% 6,745 4,090 65% 17,647 15,766 12% 958 929 2,346 2,377 5,787 3,161 83% 15,301 13,389 14% 2 4 10 15 $ 5,785 $ 3,157 83% $ 15,291 $ 13,374 14% $ 2.32 $ 1.24 87% $ 6.08 $ 5.26 16% 2,498 2,541 2,514 2,543 14.2 % 22.7 % 13.3 % 15.1 % GAAP Acquisition- and Divestiture-Related Costs (1) Restructuring Costs (2) (Income) Loss from Investments in Equity Securities Certain Other Items Adjustment Subtotal Non-GAAP $ 3,855 621 110 731 $ 3,124 2,633 34 34 2,599 4,234 4 233 237 3,997 47 47 47 – (238 ) (344 ) (344 ) 106 6,745 (659 ) (390 ) 344 (705 ) 7,450 958 (119 ) (3) (82 ) (3) 73 (3) 86 (4) (42 ) 1,000 5,787 (540 ) (308 ) 271 (86 ) (663 ) 6,450 5,785 (540 ) (308 ) 271 (86 ) (663 ) 6,448 $ 2.32 (0.22 ) (0.12 ) 0.11 (0.03 ) (0.26 ) $ 2.58 14.2 % 13.4 % $ 10,831 1,817 311 2,128 $ 8,703 7,835 72 1 73 7,762 11,903 14 286 300 11,603 676 676 676 – (281 ) (3 ) (512 ) (515 ) 234 17,647 (1,900 ) (1,274 ) 512 (2,662 ) 20,309 2,346 (338 ) (3) (239 ) (3) 109 (3) (60 ) (4) (528 ) 2,874 15,301 (1,562 ) (1,035 ) 403 60 (2,134 ) 17,435 15,291 (1,562 ) (1,035 ) 403 60 (2,134 ) 17,425 $ 6.08 (0.62 ) (0.41 ) 0.16 0.02 (0.85 ) $ 6.93 13.3 % 14.2 % 2025 2024 3Q Sep YTD 1Q 2Q 3Q Sep YTD 1Q 2Q 3Q Sep YTD 4Q Full Year Nom % Ex-Exch % Nom % Ex-Exch % $15,529 $15,806 $17,276 $48,611 $15,775 $16,112 $16,657 $48,544 $15,624 $64,168 4 3 0 1 13,638 14,050 15,611 43,299 14,006 14,408 14,943 43,358 14,042 57,400 4 3 0 0 7,205 7,956 8,142 23,303 6,947 7,270 7,429 21,646 7,836 29,482 10 8 8 8 312 370 379 1,061 292 317 337 947 365 1,311 12 12 12 12 258 265 258 781 255 249 251 755 255 1,010 3 2 3 3 137 162 196 496 85 126 139 349 160 509 42 41 42 42 119 107 136 361 71 90 100 261 110 371 36 36 39 39 1,327 1,126 1,749 4,202 2,249 2,478 2,306 7,032 1,550 8,583 -24 -25 -40 -40 539 609 684 1,832 570 617 703 1,891 594 2,485 -3 -3 -3 -3 230 229 226 685 219 189 239 647 161 808 -6 -7 6 6 228 121 204 554 216 163 193 572 139 711 6 5 -3 -3 107 129 244 480 47 47 50 97 * * * * 41 38 45 124 61 59 68 188 74 263 -34 -35 -34 -34 441 461 439 1,341 440 455 420 1,315 449 1,764 5 4 2 2 208 228 266 702 174 188 208 570 215 785 28 25 23 23 70 74 81 225 56 62 64 182 70 252 25 24 24 24 83 96 43 222 73 92 96 261 79 340 -55 -55 -15 -15 280 336 360 976 70 149 219 200 419 141 141 * * 106 123 112 340 98 106 102 306 109 415 9 9 11 11 68 80 82 229 70 72 72 214 73 287 14 7 7 5 102 83 138 323 350 110 383 843 121 964 -64 -65 -62 -62 90 86 82 258 111 89 102 302 92 394 -20 -21 -15 -14 67 83 77 228 56 60 65 180 69 249 19 13 26 24 45 41 43 128 42 39 42 123 40 163 1 -1 4 4 50 40 47 137 46 53 78 177 45 222 -40 -40 -23 -22 184 172 189 545 543 -100 -100 -100 -100 39 35 41 115 114 -100 -100 -100 -100 549 372 382 1,302 419 405 278 1,102 232 1,334 37 37 18 19 247 251 243 741 251 224 204 679 255 935 19 20 9 11 729 584 953 2,268 632 618 638 1,890 699 2,590 50 49 20 21 1,588 1,646 1,615 4,849 1,511 1,482 1,487 4,480 1,397 5,877 9 7 8 10 924 961 1,023 2,909 850 837 886 2,573 889 3,462 16 14 13 15 664 685 592 1,940 661 645 601 1,907 508 2,415 -2 -3 2 2 303 110 50 463 258 222 227 706 185 891 -78 -27 -34 -4