Olpasiran

Amgen 上调 2025 财年营收指引至 358 亿–366 亿美元，推出 AmgenNow 平台 管理层观点 CEO Robert Bradway 表示：“Amgen 又度过了一个强劲的季度，业绩得益于药品需求增长和管线项目的实质性进展。在全行业销售价格下降的环境中，销量增长再次成为推动我们前进的核心动力。” 他强调，公司营收同比增长 12%，销量增长 14%，其中 16 款产品实现两位数增长。Bradway 宣布在美国推出 AmgenNow —— 一款面向患者的 Repatha 直达平台，并称之为“帮助更多人受益于像 Repatha 这样创新成果的重要一步”。他指出公司在四大治疗领域均实现扩张，并强调生物列斯药收入同比增长逾 50%，年化销售额已达约 30 亿美元。 Bradway 确认，今年计划在美国投资超过 30 亿美元用于制造扩产，自 2017年以来的累计投资已超过400亿美元。他强调对MariTide和 Olpasiran 等即将上市产品的强劲势头充满信心，并重申 Amgen 有能力保持长期增长。他表示：“我们对业务势头感到振奋，并对在未来十年持续实现创新与增长充满信心。” CFO Peter Griffith 表示：“第三季度公司营收同比增长 12% 至 96 亿美元，反映了包括 Repatha、EVENITY、TEZSPIRE 以及创新肿瘤、罕见病与生物仿制药组合在内的六大关键增长引擎的持续强劲表现。” Griffith 提到，美国销售抵扣项目带来 2.5 亿美元 的有利影响，并获得 9000 万美元 的 Nplate 政府订单。他指出，非 GAAP 营业利润率为 47%，研发投入同比增长 31%，并表示：“我们很高兴地报告，公司已提前恢复至收购 Horizon 之前的资本结构，并将在 2025 年实现超过 5 亿美元的税前成本协同效应。” 公司将 2025 财年总营收指引上调至 358 亿–366 亿美元，非 GAAP 每股收益（EPS）上调至 20.60–21.40 美元。 执行副总裁 Murdo Gordon 报告称，销售额同比增长 12%，由 14% 的销量增长推动。他特别强调 Repatha 销售增长 40%，并宣布 AmgenNow 计划的推出，其月度定价为 239 美元。EVENITY 销售同比增长 36%，TEZSPIRE 销售同比增长 40%。罕见病组合收入增长 13% 至 14 亿美元，生物仿制药销售增长 52% 至 7.75 亿美元。 展望 Amgen 上调 2025 财年营收指引至 358 亿–366 亿美元，非 GAAP 每股收益上调至 20.60–21.40 美元。Griffith 表示：“该指引已计入已实施的关税的预计影响，但未考虑已宣布但尚未实施的关税或定价措施。” 公司预计研发（R&D）投资将继续上升，2025 财年非 GAAP 研发费用预计同比增长中 20% 区间。非 GAAP 其他收入及支出（OI&E）预计为 21 亿–22 亿美元，非 GAAP 税率预计为 15.0%–16.5%。2025 财年资本支出预计为 22 亿–23 亿美元。第四季度不预期 WEZLANA 有任何销售。公司继续预计全年非 GAAP 营业利润率约为 45%。 财务业绩 公司营收同比增长 12% 至 96 亿美元，非 GAAP 营业利润率 47%。第三季度自由现金流（Free Cash Flow）为 42 亿美元。报告显示 RAVICTI 销售额 1.05 亿美元，并提及 2.5 亿美元 的美国销售抵扣利好与 9000 万美元 的 Nplate 政府订单。股息支付为 每股 2.38 美元，同比增长 6%。 产品亮点包括： Repatha 季度销售额 7.94 亿美元，EVENITY5.41 亿美元，Prolia11 亿美元，UPLIZNA1.55 亿美元，TEPEZZA5.60 亿美元，TAVNEOS1.07 亿美元，TEZSPIRE3.77 亿美元，IMDELLTRA1.78 亿美元。生物仿制药组合销售额达 7.75 亿美元。 以下为财报电话会全文： Amgen Inc. (AMGN) Q3 2025 Earnings Call November 4, 2025 4:30 PM EST Company Participants Casey CapparelliRobert Bradway - Chairman, CEO & PresidentPeter Griffith - Executive VP & CFOMurdo Gordon - Executive Vice President of Global Commercial OperationsJames Bradner - Executive Vice President of Research & Development Conference Call Participants Salveen Richter - Goldman Sachs Group, Inc., Research DivisionTerence Flynn - Morgan Stanley, Research DivisionJay Olson - Oppenheimer & Co. Inc., Research DivisionMatthew Phipps - William Blair & Company L.L.C., Research DivisionYaron Werber - TD Cowen, Research DivisionChristopher Schott - JPMorgan Chase & Co, Research DivisionEvan Seigerman - BMO Capital Markets Equity ResearchMichael DiFiore - Evercore ISI Institutional Equities, Research DivisionDavid Amsellem - Piper Sandler & Co., Research DivisionDavid Risinger - Leerink Partners LLC, Research Division Operator 我叫 Julianne，今天将担任本次安进公司2025 年第三季度财报电话会议的主持人。（按照会议指令进行操作）现在请允许我介绍安进公司投资者关系副总裁 Casey Capparelli。Capparelli 先生，请开始您的发言。 Casey Capparelli 谢谢你，Julianne，下午好，大家好。欢迎参加我们 2025 年第三季度财报电话会。接下来将由 Bob Bradway 主持会议，随后 Peter Griffith、Murdo Gordon 和 Jay Bradner 将分别从各自领域对公司业绩进行全面回顾。 在今天的讨论过程中，我们将使用非 GAAP 财务指标来描述公司的业绩表现，并在随附材料中提供了相应的调节说明。我们还会发表一些前瞻性声明，这些声明受到安全港条款的约束，请注意实际结果可能会与声明存在重大差异。 Robert Bradway董事长、首席执行官兼总裁 下午好，感谢大家今天的参与。Amgen 本季度再次取得了强劲表现，受益于药品需求的持续增长以及管线项目的显著进展。在整个行业销售价格下行的环境下，我们的业绩依然由销量增长推动。这种增长反映了我们产品组合的实力以及药物为患者与医生带来的价值。本季度我们在四大治疗领域均实现增长。收入同比上升 12%，销量增长 14%。其中 16 个产品实现了两位数增速，14 个产品年化销售额已超过 10 亿美元。我们广泛的创新药物阵列正在形成强大动能，让我们有信心维持长期增长。 我们也在持续扩大药物可及性。近期推出了 AmgenNow 这一全新的直达患者平台，使符合条件的美国患者能够以全球最低价格之一获取 Repatha。这是让更多人从 Repatha 这类创新药中受益的重要一步。 我要特别强调一下生物制剂生产的规模与复杂性——这既是科学也是艺术。Amgen 在大分子药物生产方面拥有世界领先的能力，受益于 45 年的经验积累，以及主要布局于美国的制造网络，自创立以来始终为美国及全球患者服务。我们继续加大制造投资，仅 2025 年在美国的投资计划就超过 30 亿美元。自 2017 年《减税与就业法案》通过以来，公司已在制造与研发领域累计投入 400 多亿美元。这一基础为我们满足全球日益增长的产品需求奠定了坚实根基。 接下来简要谈谈四大治疗领域。在普通医学方面，我们在未被充分服务的疾病领域持续扩大影响力。心血管疾病依然是全球首要公共健康挑战，数千万患者存在心梗与中风风险。在即将召开的美国心脏学会（AHA）年会上，我们将公布 Repatha 关于预防首次心梗或中风的关键数据，这是 Repatha 在一级预防领域潜在影响的重要信号。 在骨健康方面，EVENITY 正在重塑高骨折风险绝经后女性的治疗格局。它是首个也是唯一能同时促进骨生成并抑制骨吸收的骨形成药物。EVENITY 表现持续强劲，鉴于高危女性的治疗率仍然偏低，我们认为其仍具显著增长空间，有望贯穿整个生命周期成为增长引擎。 展望未来，MariTide 与 Olpasiran 将在肥胖症与心血管疾病两大领域提供新的增长路径——这也是全球最紧迫的健康挑战之一。 在罕见病领域，我们的增长型产品群都处于生命周期早期。这些产品目前表现良好，并预期将持续成长。例如，随着 UPLIZNA 即将在 IgG4 相关疾病及重症肌无力（gMG）等新适应症上拓展，我们对其能惠及更广泛患者群体感到振奋。同时，UPLIZNA 在多种疾病中展现的进展，也进一步验证了 CD19 靶向疗法在多类罕见自身免疫病中的潜力。 在炎症领域，我们深耕多年，对 TEZSPIRE 的表现非常鼓舞。医生们越来越熟悉其特征，认可其良好的耐受性与广谱疗效。TEZSPIRE 能够在炎症级联反应上游进行干预，我们对其长期前景保持高度信心。 在肿瘤学方面，我们持续确立新的治疗标准。IMDELLTRA 在小细胞肺癌中引发了强烈的临床关注。BLINCYTO 已稳固确立为 B 细胞急性淋巴细胞白血病（B-ALL）一线巩固治疗的标准疗法；而 xaluritamig 在前列腺癌 III 期试验中也取得令人鼓舞的进展。 与此同时，我们的生物类似药策略亦持续奏效。本季度该业务收入同比增长超 50%，年化销售额已约 30 亿美元。 最后，我想说，公司持续与华盛顿及全球政策制定者合作，推动改善药物可及性、保护创新并强化生物制造生态体系的政策，尤其在美国。我们已为 2026 年打下坚实跳板。下一波增长的核心产品已在手中，数据支持充分，今年还将迎来多项关键读出，并且大多处于生命周期早期。我们对业务动能充满信心，也坚信能在未来十年持续交付创新与增长。 感谢全球同事为患者所作出的努力。接下来交给 Peter 介绍财务情况。 Peter Griffith执行副总裁兼首席财务官 谢谢，Bob。我们对第三季度的强劲表现感到满意，并保持 2025 全年目标及长期规划的稳步推进。财务结果详见 Slide 6 和 7。本季度收入同比增长 12%，达到 96 亿美元，反映出 6 大增长驱动品种的持续强势，包括 Repatha、EVENITY、TEZSPIRE 及我们创新肿瘤、罕见病与生物类似药组合。本季度还受若干一次性项目提振，包括 2.5 亿美元来自美国销售扣减估算调整，以及 9000 万美元的 Nplate 政府订单。同时，季度中 RAVICTI 销售额 1.05 亿美元，该罕见病小分子药物自 10 月起已有仿制药竞争者上市。 非 GAAP 营业利润率为 47%，反映出全业务线的显著投入，其中非 GAAP 研发支出同比增长 31%，约 2 亿美元源于多项业务开发交易。若剔除这些交易，三季度非 GAAP 运营费用同比上升 14%，非 GAAP 研发支出增长 19%，主要用于后期管线项目。 持续投资的项目包括 MariTide、Olpasiran、xaluritamig 以及多项罕见病项目，将推动公司长期可持续增长并强化创新领导力。 非 GAAP 其他收入与费用为 5.68 亿美元支出。我们持续优化资产负债表，2024 年已偿债 45 亿美元，2025 年再偿 60 亿美元。欣然报告，公司已提前恢复至 Horizon 收购前的资本结构，并将在 2025 年实现超过 5 亿美元税前成本协同。非 GAAP 税率同比上升 4.8 个百分点至 18.2%，主要因盈利结构变化所致。 第三季度自由现金流 42 亿美元，反映出业务稳健增长与营运资金管理严格，同时持续加码创新投入。除 31% 的 R&D 提升外，我们也在研发、生产与商业环节全面推进人工智能（AI）与数据化。包括临床试验入组、制造优化、客户互动等领域，都在利用 AI 加速提升效率。同时，在分子设计及早期研究方面，现代化 AI 与数据平台也显著提速创新。 2025 年资本开支预计 22 亿至 23 亿美元，用于扩充产品及管线（含 MariTide）产能。投资主要分布在美国 Ohio、North Carolina、Puerto Rico、Rhode Island、California 及 Massachusetts，各项目均按预算、按进度推进。此外，公司通过分红向股东回报资本，每股 2.38 美元，同比增 6%。 展望 2025 （见 Slide 8），凭借产品组合的实力与业务动能，我们上调全年收入与非 GAAP 每股收益指引。预计 2025 总收入 358 亿至 366 亿美元，非 GAAP EPS 为 20.60–21.40 美元。该指引已考虑已实施关税影响，未包含尚未执行的关税或价格政策。 此外，全年其他收入预计约 15 亿美元。非 GAAP 研发费用预计同比增长 20 % 中段，主要来自后期项目投入与三季度 BD 交易。非 GAAP OI&E 预计 21–22 亿美元。非 GAAP 税率预计 15.0–16.5%。美国市场 WEZLANA 季度销售仍将波动，预计 Q4 无销售。 其他保持不变：全年非 GAAP 营业利润率约 45%。展望继续反映对关键后期项目（MariTide、Olpasiran、罕见病、xaluritamig）及 AI 技术应用的投入。利润率预期亦计入新品上市与商业推广费用。我们专注于执行力，致力于在高未满足医疗需求领域驱动创新，同时保持财务纪律，为患者与股东创造长期价值。感谢全球同仁的奉献。这就是财务更新的全部内容。 现在交给 Murdo 介绍本季度的商业进展。 Murdo Gordon全球商业运营执行副总裁 谢谢你，Peter。第三季度销售额同比增长12%，主要由14%的销量增长推动。共有16款产品实现了两位数或更高的增长，充分体现了我们产品组合的实力，以及全球团队高效且有纪律的执行力。 首先从普通医学开始。Repatha 在第三季度实现销售额7.94亿美元，同比增长40%，年化销售额现已接近30亿美元。自十年前 Repatha 上市以来，PCSK9抑制剂这一药物类别仍未被充分利用，目前仅覆盖不到5%的潜在降脂治疗患者。全球约有1亿人仍需要有效的 LDL-C（低密度脂蛋白胆固醇）降低治疗，因此 Repatha 在应对全球第一大公共健康危机——心血管疾病方面，仍拥有巨大的增长空间。 正如你稍后将从 Jay 那里听到的，我们近期公布了 VESALIUS-CV 结局研究的重要数据，该研究在无既往心梗或中风史、但具有高心血管风险的患者中，达成了双主要不良心血管事件（MACE，major adverse cardiovascular events）终点。我在血脂管理领域工作了30多年，见证了许多里程碑式的他汀类研究，这些研究证明强化降低 LDL 胆固醇可以显著减少心血管风险。而 VESALIUS-CV 的结果显示，Repatha 在他汀治疗基础上还能进一步降低心血管事件风险，为高危人群的一级预防带来额外获益。 目前，美国超过95%的投保患者可获得 Repatha 报销，大多数患者每月自付费用低于50美元。许多患者的事前授权要求已被取消或大幅放宽。在美国，我们正在采取大胆措施提升可及性，包括推出 AmgenNow，这是一项全新的直达患者计划。Repatha 是首款通过 AmgenNow 平台提供的药物，月售价239美元，折合每日约8美元，比当前美国标价低近60%，而该标价已是全球最低之一。该计划的推出，是提升 Repatha 在美国患者可负担性与可及性的重要一步。 EVENITY 第三季度销售额5.41亿美元，同比增长36%。在美国市场，销售额增长44%，主要受益于老客户与新启动医生处方量的提升。EVENITY 是唯一能同时促进骨生成并抑制骨吸收的药物，这一独特机制可帮助绝经后女性降低骨折风险。在美国，EVENITY 继续在骨形成药物细分市场中保持领先，市占率超过60%，至今约27万名患者接受治疗。然而，仍有大量高危患者未被充分治疗，约200万高危患者中有近90%尚未接受合适的疗法。在日本，自上市以来已有约80万名患者使用 EVENITY，使其在骨形成药物领域的市占率超过50%。EVENITY 在日本的成功证明了美国市场仍有巨大潜力——通过改进筛查与诊断、提升治疗率，可显著扩大患者覆盖并推动持续增长。 Prolia 销售额达11亿美元，同比增长9%。目前美国市场已有3款生物类似药上市，竞争格局正按预期演进。未来几个季度，我们预计竞争加剧将对 Prolia 销售造成负面影响。 我们的罕见病产品组合同比增长13%，达到14亿美元，年化销售额超过50亿美元，各品类均表现强劲。UPLIZNA 销售额同比增长46%，达1.55亿美元。UPLIZNA 在 IgG4 相关疾病中的上市表现良好，风湿病学医生及主要学术医疗中心的采用速度可观。虽然 IgG4 相关疾病是近年来才被定义的疾病，我们的教育推广正迅速提升医生认知与诊断率。 自上市以来，我们已看到超过300位独立医生在多学科领域开具 UPLIZNA，显示其在该适应症中的广泛应用。UPLIZNA 是获 FDA 批准的神经视神经脊髓炎谱系障碍（NMOSD）领先疗法，增长主要由新患者需求增加及治疗启动和依从性提升推动。此外，我们正在为 UPLIZNA 在全身性重症肌无力（generalized myasthenia gravis, gMG）的预期批准做上市准备。这是一种由致病性 B 细胞介导的慢性自身免疫性神经肌肉疾病。我们期待未来能让更多患者受益于 UPLIZNA 的差异化特性，包括持久疗效与便利的给药方式。 TEPEZZA 本季度销售额增长15%，达5.6亿美元，主要受库存与价格提升推动。我们对其在日本的上市表现感到鼓舞，自去年12月以来，已有超过800名患者接受 TEPEZZA 治疗。在美国，自上市以来约有2.5万名患者接受该药。为了让更多可受益的患者获得治疗，我们持续扩大医生覆盖面，并观察到医生开具意愿的上升。 TAVNEOS 第三季度销售额1.07亿美元，同比增长34%，由强劲的销量增长驱动。至今，美国已有超过6700名 ANCA 相关血管炎患者接受 TAVNEOS 治疗。超过3800位医疗专业人员已开具该药，较年初增长31%，显示处方基础持续扩大。 在炎症领域，TEZSPIRE 再度录得强劲季度表现，销售额同比增长40%，达到3.77亿美元，年内累计销售已超过10亿美元。TEZSPIRE 具有差异化且广谱的药理特性，能针对多种严重难治性哮喘的诱因与驱动因素，为美国更多患者带来治疗机会。此外，TEZSPIRE 近期在美国获批用于12岁及以上成人及青少年慢性鼻窦炎合并鼻息肉（chronic rhinosinusitis with nasal polyps, CRSwNP）的联合维持治疗。该疾病与嗜酸性粒细胞升高有关，约见于20%的严重哮喘患者。此批准进一步强化了 TEZSPIRE 在嗜酸性粒细胞相关疾病中的确证疗效。值得注意的是，在该注册性试验中，TEZSPIRE 还显示出显著减少手术需求的效果，进一步提升其临床价值及潜在患者覆盖范围。 我们的创新肿瘤产品组合包括 BLINCYTO、IMDELLTRA、LUMAKRAS、Vectibix、KYPROLIS、Nplate 和 XGEVA，本季度合计销售额23亿美元，同比增长9%。 肿瘤业务增长动力来自我们行业领先的双特异性T细胞连接器平台，它构成了 IMDELLTRA 和 BLINCYTO 的技术基础。这些药物正在重新定义难治性癌症的治疗标准，并延长全球更多患者的生存期。IMDELLTRA 第三季度销售额1.78亿美元，受强烈的临床信心与快速采用推动。IMDELLTRA 被广泛视为广泛期小细胞肺癌在化疗失败或进展后的标准治疗。美国已有超过1400个治疗点可提供 IMDELLTRA，其中超过一半的剂量在社区医疗机构完成。基于 III 期 DeLLphi-304 研究的优异临床结果，NCCN 指南已更新，将 IMDELLTRA 作为二线治疗的最高推荐方案。我们期待该药在今年晚些时候获得正式的完全确认性批准。 BLINCYTO 销售额同比增长20%，达3.92亿美元，受学术机构与社区医生的广泛处方推动。BLINCYTO 作为费城染色体阴性 B 细胞急性淋巴细胞白血病（Philadelphia chromosome-negative B-cell ALL）的标准治疗，与多药化疗联合使用，在成人与儿童患者中均表现出坚实的临床共识。 我们的生物类似药组合本季度表现同样强劲，销售额同比增长52%，达7.75亿美元，年化销售额约30亿美元。自2018年首个产品获批以来，生物类似药累计创造近130亿美元销售额。新产品上市为公司带来了显著的营收增长与持续现金流。EYLEA 的生物类似药 PAVBLU 继续取得进展，第三季度销售额达2.13亿美元。视网膜专科医生对 PAVBLU 的反响非常积极，认为其预充注射器形式方便实用，而安进在高质量生物类似药制造方面的声誉也是关键竞争优势。 我对本季度的业绩表现感到非常满意，这一成果来自全球安进员工始终如一的承诺——践行公司的使命，为患者服务。 现在，我将把发言权交给 Jay。 James Bradner执行副总裁，研发部 谢谢你，Murdo。下午好，大家好。第三季度是我们研发部门执行力强劲且纪律严明的一个季度。我们推动了多个后期临床项目的进展，并进一步巩固了已上市药物的循证基础。 首先谈 MariTide。我们的两项Ⅲ期慢性体重管理研究已全部完成入组，在大约6个月的时间里共招募约5000名成年人，显示出极高的关注度。我们也迅速进入了另外两项Ⅲ期研究：MARITIME-CV 与 MARITIME-HF，分别用于研究动脉粥样硬化性心血管疾病与心力衰竭，且入组势头强劲。回顾我们的Ⅱ期慢性体重管理研究，我们观察到收缩压、甘油三酯以及高敏C反应蛋白（hs-CRP，血管炎症关键标志物）均显著下降，这些经验证的心血管风险因子得到统计学显著改善，突显了 MariTide 在减重之外的潜在心血管获益。 我们还启动了两项阻塞性睡眠呼吸暂停的Ⅲ期研究。至此，MariTide 已有6项全球Ⅲ期临床正在进行，正在建立坚实的循证基础。除 MariTide 外，我们也在推进早期肥胖及肥胖相关疾病项目组合，其中包括处于Ⅰ期的 AMG 513 以及多个处于临床前阶段的候选药物，覆盖 incretin 与非 incretin 靶点，并包含口服与注射两种给药途径。 在肥胖以外的普通医学领域，正如 Murdo 所提到的，Repatha 的Ⅲ期临床研究 VESALIUS-CV 达到了双主要终点，显示在无既往心梗或中风史的高危人群中，可显著降低主要不良心血管事件（MACE）风险。VESALIUS-CV 提出了一个临床关键问题：对于尚未发生过心梗或中风但风险较高的人群，在优化降脂治疗基础上加用 Repatha 是否能进一步获益。 这项里程碑式的研究共纳入超过12,000名患者，其中约85%在基线时已接受中度至强化他汀类降脂治疗。中位随访约4.5年后，两项主要 MACE 终点均达标，且未发现新的安全性信号。我们非常期待在11月8日的美国心脏学会科学年会上（AHA Scientific Sessions）公布完整结果，届时欢迎大家详细阅读数据。 除了 VESALIUS-CV 数据外，我们还将展示若干真实世界研究，内容涵盖当前血脂管理现状、Repatha 在临床实践中的疗效，以及来自 FOURIER 开放标签延伸研究的新数据。这些结果共同强化了 Repatha 的长期疗效与既有安全性，同时为动脉粥样硬化性心血管疾病风险管理提供新的洞见。我们心血管研究项目的规模、广度与雄心，结合临床试验的疗效数据与真实世界的有效性结果，体现了安进在心血管疾病领域坚定的承诺，以及像 Repatha 这样可负担的变革性药物对患者护理所能产生的深远影响。 接下来是 Olpasiran。这是一款我们极具潜力的同类最佳小干扰RNA（siRNA, small interfering RNA）药物，靶向脂蛋白(a)〔Lp(a)〕。我们很高兴看到事件驱动型Ⅲ期心血管结局研究 OCEAN(a) 的顺利推进与良好执行。我们持续监测主要复合终点事件累积速率，目前略低于最初预测。随着研究成熟，我们将适时更新主要分析的时间节点。我们对降低 Lp(a) 能减少心血管事件这一科学假设保持高度信心，这一信念源自强有力的遗传学与流行病学数据，它们清晰地将 Lp(a) 升高与心血管疾病风险联系起来。 在罕见病方面，关于 UPLIZNA，我们近期公布了Ⅲ期 MITIGATE 研究在 IgG4 相关疾病中的进一步数据，包括按基线特征与受累器官（如胰腺、肾脏、胆管）分层的亚组分析。这些数据表明，各亚组疗效与整体研究人群相当，进一步支持 UPLIZNA 在 IgG4 相关疾病患者群体中的广泛潜力。针对全身性重症肌无力，我们正期待12月14日的 PDUFA 审评节点，并持续收到医生积极反馈，反映市场对高活性、持久有效且便捷治疗方案的强烈需求与期待。 在炎症领域，我们对 TEZSPIRE 获得美国 FDA 与欧盟委员会批准用于12岁及以上患者的不充分控制的慢性鼻窦炎伴鼻息肉的联合维持治疗感到振奋。支持该批准的Ⅲ期数据表明，TEZSPIRE 可带来快速且持久的症状改善，并显著减少系统性糖皮质激素（systemic steroid）使用。尤其值得注意的是，在接受 TEZSPIRE 治疗的患者中，我们几乎未观察到手术干预需求。此外，我们的两项 TEZSPIRE Ⅲ期慢性阻塞性肺疾病（chronic obstructive pulmonary disease, COPD）研究正在入组血液嗜酸性粒细胞计数≥150个/μL的中度至极重度 COPD 患者。 我们针对嗜酸性食管炎（eosinophilic esophagitis）的Ⅲ期研究也在稳步推进。TEZSPIRE 通过靶向胸腺基质淋巴细胞生成素（TSLP, thymic stromal lymphopoietin），即炎症级联反应顶端的报警因子，从而针对以 Th2 炎症驱动的严重炎症疾病的根源进行干预。 接下来是肿瘤学。我们的双特异性 T 细胞连接子平台正为晚期癌症患者带来卓越的临床结果。IMDELLTRA，这款靶向 DLL3 的 BiTE 分子，现已确立为小细胞肺癌二线治疗的标准疗法，并在联合治疗及更早治疗线中产生令人信服的数据。在9月和10月，我们公布了 IMDELLTRA 在小细胞肺癌患者中，与 PD-L1 抑制剂联合一线维持治疗的 DeLLphi-303 Ⅰb期研究（Phase Ib）多个研究队列结果。IMDELLTRA 实现了25.3个月的总生存期，大约是现有标准疗法生存期的两倍。 在 DeLLphi-303 的其他研究队列中，IMDELLTRA 作为一线方案，与含铂化疗药及 PD-L1 抑制剂联合使用，12个月总生存率达81%，中位生存期尚未达到。两种治疗方案的安全性均可控，且与各药物已知安全性一致。我们现正于关键Ⅲ期研究 DeLLphi-305（一线维持）与 DeLLphi-312（一线诱导与维持）中评估这些联合方案。 此前我们已公布 DeLLphi-304 的卓越结果，该研究比较 IMDELLTRA 与标准治疗在经含铂一线化疗后复发的广泛期小细胞肺癌患者中的疗效。美国 FDA 已受理监管申报，PDUFA 审评日期为2025年12月18日。多个国家与地区的审评也在进行中。我们正在拓展 IMDELLTRA 在小细胞肺癌及其他 DLL3 阳性肿瘤中的适应症，包括Ⅰb期研究评估创新药物组合、更低给药频率及皮下注射形式。 作为一名肿瘤学医生，我必须说，IMDELLTRA 给小细胞肺癌患者带来的改变令人深受触动。这种疾病几十年来几乎没有创新，而 IMDELLTRA 如今让许多患者重新看到希望。 对于我们的 CD19 靶向 BiTE 药物 BLINCYTO，我们持续改进并优化 B 细胞急性淋巴细胞白血病患者的标准治疗方案。近期我们启动了一项潜在注册性研究，评估皮下给药的 blinatumomab 在复发或难治性B-ALL 成人及青少年患者中的疗效。我们的首创STEAP1×CD3 双特异性 T 细胞连接药物 xaluritamig 正在Ⅲ期临床开发阶段，目前有两项研究正在进行。 第一项研究 XALute 入组既往接受过紫杉烷类化疗的转移性去势抵抗性前列腺癌（metastatic castrate-resistant prostate cancer, mCRPC）患者，比较 xaluritamig 单药与研究者选择的标准治疗。第二项研究 XALience 评估 xaluritamig 联合阿比特龙（abiraterone）与研究者选择标准治疗在未接受化疗的 mCRPC 患者中的疗效。我们也在多项Ⅰb期研究中探索 xaluritamig 在其他联合方案及前列腺癌早期阶段的应用。 总体来看，在 IMDELLTRA、BLINCYTO 与 xaluritamig 这三款药物上，我们看到双特异性 T 细胞连接平台所蕴含的长期潜力，并将持续致力于将此类创新疗法带给癌症患者。 最后，我们遗憾地宣布，FORTITUDE-102 研究——评估 bemarituzumab 联合化疗及 nivolumab 用于胃癌（gastric cancer）一线治疗的Ⅰb/Ⅲ期研究——在数据监测委员会请求的临时分析后因疗效不足被终止。我们深深感谢所有参与研究的患者、研究者与合作伙伴。我们仍然致力于在胃癌等重大未满足医疗需求领域研发创新药物。然而，本次观察到的疗效幅度未达到安进药物的标准。 除这些创新药物外，我们下一代生物类似药管线也在推进Ⅲ期临床开发，包括针对 OPDIVO、KEYTRUDA 与 OCREVUS 的生物类似药。 凭借在四大治疗领域的广度与深度，我们对未来为患者带来更多成果充满信心，也具备实现长期可持续增长的有利条件。 最后，感谢安进团队以患者为中心的思维与高效执行，使这一切进展成为可能。 我现在将时间交还给 Bob 进入问答环节。 Robert Bradway董事长、首席执行官兼总裁 好的，谢谢。现在请提醒各位电话会议参与者提问的流程，我们会尽力回答尽可能多的问题。我知道现在已过整点几分钟，我们会尽量覆盖所有提问。如果未能在电话会议中解答的，我们会在会后继续与您联系，回答剩余问题。让我们开始吧。 Question-and-Answer Session Operator 我们的第一个问题来自高盛的 Salveen Richter。 Salveen RichterGoldman Sachs Group, Inc., Research Division 关于 Olpasiran，你们在竞争格局的背景下提到了同类最佳。你们也指出 OCEAN(a) 结局研究的事件发生率低于预期。请问你们对该项目的信心如何？事件率意味着基线读出时间会推后吗？是否会从此前预计的 2026 年底延后到 2027 年？ 另外，从 BD的角度看，你们提到公司杠杆率已回到收购 Horizon 之前的水平。这将如何影响你们进入 2026 年的 BD 策略？ James BradnerExecutive Vice President of Research & Development 非常感谢你，Salveen。关于 Olpasiran 的第一个问题由我来回答。正如我刚才所说，我们的信念依然非常坚定。关于 Lp(a) 与心血管疾病的遗传学关联在人类遗传学与流行病学数据中都清晰无比。Lp(a) 从根本上说是一种炎症性脂蛋白颗粒（inflammatory lipoprotein particle），我们对其在血管床中的生物学理解很多，可以类比 LDL-C。Olpasiran 拥有真正的同类最佳属性：给药频率更优、对 Lp(a) 的抑制深度更好，并且安全性谱非常干净。 OCEAN(a) 是一项事件驱动型研究。我们对开展此类全球性研究已非常熟练——看看 VESALIUS-CV 就知道。我们对研究执行非常满意，也期待在读出时看到 Olpasiran 的影响。我们今天不会给出具体日期的指引，但随着时间节点逐步明朗，我们会及时向各方更新。 Robert BradwayChairman, CEO & President Salveen，我不会认为回到 Horizon 收购前的杠杆水平会在很大程度上改变我们对业务开发的看法。正如你所了解的，我们在 BD 上一直在积极寻找机会。我们尤其聚焦于你熟悉的、与我们战略兴趣一致的治疗领域。 考虑到我们目前在后期临床阶段有相当多的项目，我们主要聚焦于更早期的机会。好消息是，这类早期机会本来就多于后期项目。所以我们的立场是：聚焦、开放、持续在做，而且一直在做。谢谢你的提问。 Operator 下一个问题来自摩根士丹利的 Terence Flynn。 Terence FlynnMorgan Stanley, Research Division Peter，我想从高层面请教一下。我知道你们现在不会给出 2026 年的指引，但能否带我们梳理一下进入 2026 年时，我们需要考虑的利多与利空因素？ 另外，Jay，关于 ROCKET ASTRO 我有个澄清。我注意到你们完成了那项试验，并表示安全性与既往一致。我想确认一下该研究中是否出现了胃肠道溃疡（gastrointestinal ulcerations）？我记得你们在之前的一些研究中观察到过这类事件。 Peter GriffithExecutive VP & CFO 好的，Terence，非常感谢你的问题。谈到公司前景与收入端（top line），我会首先指向我们的关键增长驱动：我们刚刚度过了非常出色的一个季度，销量增长 14%；Repatha、EVENITY、TEZSPIRE 表现强劲；创新肿瘤与罕见病年化已超过 50 亿美元；生物类似药年化接近 30 亿美元。我们就是这样看待业务走向的。 顺着损益表（P&L）往下，也许我最容易做的是花一点时间谈谈大家可能都在思考的营业利润率。过去几年我们已经说得很清楚：当有机会获得超过门槛回报率的现金回报，我们就会为股东去抓住这些机会。这一点没有变化。2024 年我们的运营利润率约 47%，同时我们继续加速在研发，特别是后期管线上的开发投资。 到 2025 年，我们仍将持续投资，重点仍在研发。我们会坚持有纪律的资本配置，这一点没有变化。正如 Bob 刚才所说，外部与内部最好的创新始终处在我们资本配置层级的最顶端。这一点也没有变化，所以我们会继续这么做。我们尚未提供更长期的利润率目标，因此 2026 年也没有。但我想强调，我们会继续致力于在持续投资顶级创新的同时，实现行业领先的利润率。 所以在展望业务时，给你几点思路。第一，我们聚焦早期管线，正如 Bob 再次提到的，我们要通过投资最好的创新进一步夯实该部分管线。关于研发费用，我想说明：过去一年我们经历了一个我称之为“台阶式跳升”的上涨，但我们不预计未来还会有额外的台阶式上升。 至于研发费用的“利多与利空”，需要综合看待。提醒一下，2025 年我们完成了多项Ⅲ期研究，包括 Repatha 的 VESALIUS、IMDELLTRA 的确认性研究，以及若干 rocatinlimab、bemarituzumab 的研究。同时，我们也新增了 MariTide、Olpasiran 与 xaluritamig 的研究，它们会延续到 2026 年。还要提醒你，Terence，我们 2025 年全年约 45% 的非 GAAP 营业利润率指引，包含了第三季度 2 亿美元的 BD 活动，以及第四季度的一些新增上市与商业化投入。 总之，希望这些能回答你的问题，也能帮你了解我们今年的情况以及迈入 2026 年的思路。我们会继续在全公司范围内推动卓越执行、提高生产率，并进行“冷酷优先级排序”。多年来我们一直努力把公司打造成行业利润率领先者之一，并且我们预期未来仍将保持这一位置。谢谢你，Terence。 Robert BradwayChairman, CEO & President Jay，你来回应一下 ASTRO？ James BradnerExecutive Vice President of Research & Development 非常乐意。谢谢你，Terence。向在座各位说明一下，ASTRO 是一项为期 52 周的 rocatinlimab 研究，这是一款靶向 OX40 的 T 细胞再平衡（T cell rebalancing）药物。本研究入组的是中重度特应性皮炎（atopic dermatitis）青少年患者，评估了 150 mg 与 300 mg 两个剂量。我们同时评估了单药治疗以及与低剂量激素或钙调神经磷酸酶（calcineurin）调节的联合治疗。 研究在第 24 周达到了共同主要终点。安全性与其他研究非常一致。我们确实观察到胃肠道（GI）不良反应，但大多为轻度，且发生率并不高。随着我们收官 ROCKET 项目下的 8 项研究，我们也开始回顾并完善目标产品特征，很快会就此分享更多信息。 Robert BradwayChairman, CEO & President 好的。我们进入下一个问题，请大家尽量只提一个问题，这样我们就能覆盖更多的人。下一位是谁？ Operator 下一个问题来自 Oppenheimer 的 Jay Olson。 Jay OlsonOppenheimer & Co. Inc., Research Division 祝贺你们本季度的成绩。我们对 VESALIUS-CV 的结果很感兴趣，也想请教你们预计这些结果会如何影响 Repatha 的整体市场空间？另外，在 AHA 的详细披露中我们应该重点关注哪些要点？此外，是否有任何可应用于 Olpasiran 的经验教训？ Robert BradwayChairman, CEO & President Jay，我们很高兴你对 VESALIUS 研究感兴趣并感到兴奋，我们也是——期待尽快有机会向你详细介绍。也许分成两部分：Jay，你先开始，随后请 Murdo 补充。 James BradnerExecutive Vice President of Research & Development 好的，谢谢你，Jay。心血管疾病依然是头号杀手——在美国几乎每 40 秒就有一次心梗（heart attack）。全世界几乎人人都知道“坏胆固醇”也就是 LDL-C，而 Repatha 对其有显著的降低作用。我们知道“越低越好”，但全球的血脂管理依然非常不到位，全球仍有约 1 亿人需要更好的控制。Repatha 已在复发性心血管事件的预防中被扎实地确立为一种可及、可负担且高效的疗法；而在 VESALIUS-CV 中，我们提出了一个至关重要的问题：我们是否能够预防首次事件？事实证明，这是首个、也是唯一一个 PCSK9 抑制剂（PCSK9）显示出此类效应的研究。要知道，75% 的心肌梗死（MI）都是首次事件，因此这是一个极其重要的问题。我们迫不及待想在即将到来的 AHA 上分享这些数据。 尤为重要的是，正如 Murdo 在开场提到的，这项研究是在优化的降脂治疗基础上的增益。因此，对于已经使用他汀但 LDL-C 控制不足的患者与医生而言，这是一次重大的进步。我们非常期待分享完整结果。 你问到经验教训。我想说，与优秀的伙伴合作。TIMI Study Group 的表现非常出色。我们把如何开展这样规模与跨度的全球性研究的所有经验都带在身上——这次纳入了超过 12,000 名全球患者。我也认为，同时命中两个主要终点，强调了一个事实：针对炎症性脂蛋白颗粒（inflammatory lipoparticles）改善心血管照护，我们仍有很大的提升空间。Murdo？ Murdo GordonExecutive Vice President of Global Commercial Operations 我觉得你已经覆盖了大部分，Jay。我想补充的是，如果你这个周末没别的安排又很好奇，那就去新奥尔良或线上收看吧。我知道“里程碑”这个词在描述临床研究时经常被用滥，但把这个词用在这项研究上并不为过。我认为这在理解如何预防首次心梗与中风方面是一次实质性的进步。 这对全体基层全科医生来说是一声“动员令”。我们会确保在数据公布后第一时间，我们的医学团队、销售团队与患者支持组织会全面铺开，让全科医生尽快了解这些数据，同时也让患者像 Jay 所说的那样，从一种负担得起且能在所有既有降脂治疗之上提供额外风险降低的方案中受益——这就是 Repatha。 这是令人振奋的时刻。我们一直系统性地告诉各位，我们在为 Repatha 打开可及性，并且我们也在号召全科医生在心脏科之外承担更多角色。而这批数据又一次给了我们继续推进这项重要工作的机会。谢谢。 Robert BradwayChairman, CEO & President Jay，正如我们在本次电话会多次提到的，AmgenNow 显然是这里的重要一环。我们不希望任何人因为价格问题错过这种相对其获益而言极具吸引力的治疗。所以，感谢你的问题。我们继续下一位来电者。 Operator 我们的下一个问题来自 William Blair 的 Matt Phipps。 Matthew PhippsWilliam Blair & Company L.L.C., Research Division FDA 最近发布了新的生物类似药（biosimilar）指南，可能会取消对比性疗效研究的要求。我想知道这是否会改变你们对该业务的看法，比如进入壁垒，以及哪些生物制剂值得去做生物类似药的“投入产出”计算？ Murdo GordonExecutive Vice President of Global Commercial Operations 谢谢你，Matt。就我看来，这并不会改变我们在生物类似药领域的战略聚焦。这一直是安进非常好的增长型业务，我们仍然这样看待它。显然，我们会密切关注新指南，我们的研发与注册团队也会非常专注，确保随时可以按需调整。 我还想说，无论指南如何要求——是强调大量临床试验，还是强调技术可比性——安进在所有技术职能上都具备有效竞争的能力。我们的工艺开发团队在制造运营组织中持续做着非常创新的工作，例如帮助我们成为市场上唯一商业化可得的 EYLEA 生物类似药。 所以我们认为自己处在一个良好位置，我们会保持竞争力。无论最终指南如何，我们都会像我刚才说的那样仔细研读，并理解它们将如何影响未来产品的开发。 Robert BradwayChairman, CEO & President 再补充一句，Matt。从战略层面看，我注意到在一些地方，尤其是华盛顿，存在一种潜在疑问：美国的生物类似药市场是否真的运转良好。作为领先竞争者，我们的观点是——这个市场目前运行得非常好。我们认为，环境已经为其在美国继续繁荣打下了良好基础；在专利到期后，患者能够获得重要药物的替代供应。我们会密切关注，确保不会出现把这个市场引向仿制药行业（generic drug industry）模式的政策——显然，仿制药领域过去出现过相当多的乱象，引发了对该市场及其对患者影响的担忧。 相较之下，我们认为生物类似药市场目前是良性运作的。我们相信当下的监管与相关政策能够让这一态势延续。我们会继续倡导对“现行机制有效”的认可。 Operator 下一个问题来自 TD Cowen 的 Yaron Werber。 Yaron WerberTD Cowen, Research Division 很好。我有一个给 Jay 的问题。MariTide 的第二年数据预计在年底公布。我们知道你们在观察三件事情：相同剂量、更低剂量、转为安慰剂，并且你们在这项研究里测试的是每12周一次，没有每8周一次。能否透露这会不会在某个医学会议上发布？也请你们大致说说应该如何解读，把它放在怎样的背景下？ James BradnerExecutive Vice President of Research & Development 好的，谢谢你，Yaron。Ⅱ期慢性体重管理研究的第二部分（Part 2）确实非常有意思。我们在第一部分（Part 1）的 52 周已经取得了强劲的疗效，第二部分将贡献首次的维持治疗体验。提醒一下试验设计——正如你提到的——我们在测试按季度给药的全剂量方案，测试按月给药的低剂量方案，并把这些与安慰剂以及继续治疗进行比较。这些数据对我们非常关键：它将用于指导我们的维持策略，并为进一步的Ⅲ期设计提供指引。关于披露方式，我们会在合适的时候再做介绍。 Operator 下一个问题来自摩根大通的 Chris Schott。 Christopher SchottJPMorgan Chase & Co, Research Division 想问一个更宏观的肥胖（obesity）问题。最近这个领域有不少进展：比如 Metsera 的头条新闻、关于肥胖药物更低的 Medicare 定价讨论等等。我想听听安进对肥胖市场的最新看法，以及公司凭借 MariTide 与更广泛管线在该市场中的定位。想了解你们的最新全景视角。 Robert BradwayChairman, CEO & President 谢谢你，Chris。我们的答案是——我们对肥胖领域的机会依然非常乐观。正如你所知，我们坚信自己在这个市场上的方法与当前竞争者不同且差异化明显，也不同于我们观察到其他公司在其产品组合中推进的路径。因此，基于我们对自身分子的认知以及对市场的观察，我们的态度仍然非常积极。 我请 Jay 和 Murdo 也补充一下——Jay，你先来？ James BradnerExecutive Vice President of Research & Development 好的，谢谢邀请。肥胖是一个重大的公共健康危机。在美国，太多人每天都在面对它——可能有40% 的成年人BMI 超过 30，儿童里也有五分之一。它对美国医疗体系的成本也极其高昂，CDC 估算每年超过1700 亿美元。而从市场角度看——这一点 Murdo 会谈——市场仍极度渗透不足，说明医疗水平还有很大提升空间。但要改善，我们认为需要真正差异化的资产，而不只是又一个每周注射的肽类。事实也证明，让患者长期坚持这类用药非常困难——有 55% 的患者无法持续使用到年底。当然，肥胖及其相关疾病本身需要更持久、慢性的治疗。 因此我们认为 MariTide 具备极佳且差异化的特征，能在这里发挥作用。至于更广的管线：我们在肥胖与代谢医学的发现研究上已经深耕20 多年。这条管线中我们还有一个Ⅰ期资产 AMG 513，同时在 incretin 与非 incretin 通路上推进多个临床前项目，其中有口服也有注射。我们的目标是对这一重大公共健康危机产生巨大影响。Murdo？ Murdo GordonExecutive Vice President of Global Commercial Operations 谢谢，Jay。我想强调给所有听众的是：与市面上的可选方案相比，我们始终认为 MariTide 具备真正的差异化。很有意思的是——现在两家公司在竞价争夺一个通过某种脂质技术有望实现“按月给药”的 GLP-1。 而我们拥有的是一个明确按月，甚至可能更低频给药的产品。正如 Jay 所说，市场巨大且远未被满足。我们希望进入这个市场，不仅帮助肥胖患者减重，更要在长期体重管理的医疗获益上兑现承诺。我也迫不及待想看到我们Ⅲ期项目的结果，对团队的执行表现非常满意，期待那一天的到来。谢谢。 Operator 下一个问题来自 BMO Capital 的 Evan Seigerman。 Evan SeigermanBMO Capital Markets Equity Research Bob，你刚才关于生物类似药板块的评论让我印象很深。我想请你指出，从政策角度看，需要发生哪些变化才能进一步促进生物类似药的使用？举例来说，阿达木单抗市场上销量第一的仍是 HUMIRA，而不是 AMJEVITA。作为生物类似药领导者，你们如何真正推动这类产品的更广泛使用？ Robert BradwayChairman, CEO & President 是的。再次强调，在美国，B 部分（Part B）药物与D 部分（Part D）药物——也就是零售药与医生给药之间是有区别的。我认为这两个领域的市场动态在各自演化。 显然，付款方在 Part D 中非常关键，回扣机制很重要，但这会随着时间推移而减弱，我们现在就看到了这种变化。我非常有信心，从一个完整时间周期回头看，AMJEVITA（我们的阿达木单抗生物类似药）会被证明是一款非常成功的产品。我们在国际市场上已经看到了这一点，它持续表现强劲；在美国，我也认为像我们这样安全、可靠、真正等效的生物类似药，从长期来看同样会表现良好。 Operator 下一个问题来自 Evercore 的 Umer Raffat。 Michael DiFioreEvercore ISI Institutional Equities, Research Division 我是 Mike DiFiore，替 Umer 提问。我想回到 MariTide 的Ⅱ期试验。关于即将公布的 Part 2 读出，是否会有两年期的减重数据，外界有些困惑。你们能否澄清一下设计，尤其是第 52 周之后的洗脱安排？而且既然大多数患者在第一年已经减重了，是不是可以合理假设第二年（Part 2）的减重会远小于第一年（Part 1）？ Robert BradwayChairman, CEO & President 好的，Jay，你来说。 James BradnerExecutive Vice President of Research & Development 很高兴回答。正如我刚才分享的，这本质上是一项维持研究，测试低剂量月给与全剂量季给，并与安慰剂及继续以目标剂量使用 MariTide进行比较。 由于该研究的统计把握度主要是为了指导Ⅲ期设计，我们已经从 Part 1 中获得了大量指引，因此 Part 2 的某些方面会更偏描述性。你可能知道，进入 Part 2 的前提是患者在 Part 1 中需要实现超过 15% 的体重下降，然后再被随机分配到多个队列。因此，就不同队列之间的减重得出显著结论的统计把握度并不强，但会有患者按既定目标剂量继续治疗。而且由于 Part 1 中患者并未出现减重平台期，我们很感兴趣去观察这些患者在第二个自然年中的后续情况。 Robert BradwayChairman, CEO & President 为明确起见，Jay，当你说“把握度不强”时，是指研究在数值上并非为此目的而设计。 James BradnerExecutive Vice President of Research & Development 没错。正如我所说，这项研究旨在指导我们的 MariTide 维持策略以及后续Ⅲ期项目规划。我们完全预计能从 Part 2 中获得这些目的所需的全部信息。 Robert BradwayChairman, CEO & President 很好。继续下一个问题。提醒一下，现在快接近半点了，我们再接两个问题，其他各位请见谅；今天稍晚我们仍然可以接听电话。下一位请。 Operator 下一个问题来自 Piper Sandler 的 David Amsellem。 David AmsellemPiper Sandler & Co., Research Division 关于 UPLIZNA 的一个具体问题。自从IgG4 相关疾病的标签扩展以来，你们的表现相当强劲。你们能否谈谈这里是否存在累积需求的释放？也请给出对这块业务机会的最新看法。此外，关于gMG（全身性重症肌无力，generalized myasthenia gravis）的标签扩展，考虑到那是一个更竞争激烈的环境且存在一些竞品动态，你们如何看待在该适应症上的采纳速度？ Robert Bradway董事长、首席执行官兼总裁 我们来尽量高效地回答这个问题。Murdo，我想你一定也想谈谈我们在 UPLIZNA 上看到的令人振奋的动态。 Murdo Gordon全球商业运营执行副总裁 谢谢你的提问，David。显然，我们目前仍处于 IgG4 适应症上市的早期阶段。正如我提到的，目前大约有 300 位独立医生已为 IgG4 相关疾病开具了 UPLIZNA。我不太会称之为“积压需求”，因为 IgG4 是一种直到 2023 年才拥有自己 ICD-10 诊断代码的疾病。因此，患者往往不会以一个明确诊断呈现给医生。所以，我们实际上看到的是——通过教育推广与认知提升，加上 UPLIZNA 是目前唯一获得 FDA 批准用于 IgG4 的治疗药物——这一组合正在成为推动进一步增长的重要催化剂。 估计美国大约有 2 万名 IgG4 患者，但正如我所说，由于诊断编码刚刚确立，实际市场规模可能远超这一数字。我们已经展示了压倒性的疗效：在患者群体中可将疾病复发减少高达 87%，显著减少激素使用，使许多病情严重的患者实现疾病缓解与复发减少。这是一种非常重要的疗法，对我们帮助极大。Jay 会进一步展开。 在把话交给他之前，我想补充一点。在 gMG（全身性重症肌无力）方面，我们预计将在该市场建立强劲存在。根据 MINT 试验展示的疗效特征，我们拥有一个非常便利的给药方案：初始负荷剂量后，仅需每年两次给药，且疗效持久——可能比现有一些药物更为持久。由于相关数据已公开，治疗 gMG 患者的医生群体对此表现出浓厚兴趣。 关于 gMG，还要考虑到该领域存在大量治疗切换与治疗类别更替。通常，患者使用某个主要治疗的时间不会超过 1 至 1.5 年，他们平均会接触至少 2 种药物，有时甚至 3 种，直到病情稳定。所以，尽管竞争者众多，这个市场仍是一个未被完全满足的市场。Jay？ James Bradner执行副总裁，研发部 谢谢你，Murdo。我认为，正如他所说，我们的差异化非常显著，这主要归功于对疾病核心生物学机制的靶向。靶向 CD19 阳性细胞意味着覆盖整个 B 细胞群体——不仅包括成熟 B 细胞，也包括开始产生自身抗体（autoantibodies）的未成熟细胞。正因如此，尽管跨研究比较一向要谨慎，我们在 MG-ADL（Myasthenia Gravis Activities of Daily Living）这一标准指标上看到了数值上更高的疗效；同时在激素节省（steroid sparing）方面优于 FcRn（新生儿 Fc 受体）抑制类药物。 正如 Murdo 所说，我们观察到极其持久的疗效，在随机对照期内表现出显著稳定性。同时，凭借负荷剂量后每 6 个月一次给药的显著给药优势，UPLIZNA 在 gMG 以及其他由致病性自身抗体驱动的疾病中都展现出长期且持续的疗效。 正如你可能知道的，我们目前也在开展 inebilizumab 与 blinatumomab 的自身免疫性疾病研究，这些项目正在积极入组，属于一个非常动态且令人振奋的领域，多个 CD19 类药物在严重与晚期自身免疫病中展示出深远疗效。而我们拥有两款已上市品牌，因此完全有条件抓住这一机会，为患者带来帮助。 Operator 今天的最后一个问题来自 Leerink Partners 的 Dave Risinger。 David RisingerLeerink Partners LLC, Research Division 感谢你们带来的更新。我想请问，你们能否指出在未来 6 到 12 个月内最值得关注、对安进最具影响力的两到三个管线项目？ Robert BradwayChairman, CEO & President Jay，你来谈谈你重点关注的几个项目吧？ James Bradner执行副总裁，研发部 当然。目前我显然对即将发布的 VESALIUS-CV 结果最为兴奋——我们将在一周后公布。我强烈建议大家密切关注。此外，IMDELLTRA 和 tarlatamab 的进一步开发同样令人振奋。我们从临床病例中收到的反馈极具冲击力：患者在极度危重的情况下被救回来，这种效果令人动容。 正如我们从blinatumomab 的经验所见，将 tarlatamab 与 IMDELLTRA 推进到联合治疗、一线治疗以及肿瘤负荷较低的场景中，都展现出巨大潜力。正如在世界肺癌大会与 ESMO 上展示的 DeLLphi-303 研究所示，它们在Ⅲ期一线研究中呈现出极具意义的疗效。David，这就是那种让人恨不得时间快点过去、早点看到Ⅲ期读出结果的时刻。 Robert Bradway董事长、首席执行官兼总裁 在这次电话会前，我们看到了一个患者的 PET 扫描数据，这位病人病情非常严重，但正经历显著的治疗反应。我们对这款药物非常兴奋。正如有人在 ESMO 上形容的那样——“wow 的平方”。请持续关注，我们对未来一段时间内 IMDELLTRA 平台（IMDELLTRA platform）的数据充满期待。 好了，非常感谢大家今天的关注与参与。Casey 及其团队将在今天下午与晚上保持联络，若有未能提出的问题，可继续沟通。我们期待下个季度再与各位相见。谢谢。 Operator 本次安进公司 2025 年第三季度财报电话会议到此结束。您现在可以挂断电话。

THOUSAND OAKS, Calif., Nov. 4, 2025 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced financial results for the third quarter of 2025. "We delivered strong volume growth this quarter, reflecting the demand for our medicines and the impact we're having on patients worldwide. With disciplined investment and a pipeline of first-in-class medicines, we're focused on expanding access, advancing innovation, and sustaining long-term growth," said Robert A. Bradway, chairman and chief executive officer. Key results include: For the third quarter, total revenues increased 12% to $9.6 billion in comparison to the third quarter of 2024. Product sales grew 12%, driven by 14% volume growth, partially offset by 4% lower net selling price. Sixteen products delivered at least double-digit sales growth in the third quarter, including Repatha® (evolocumab), EVENITY® (romosozumab-aqqg), IMDELLTRA® (tarlatamab-dlle)/IMDYLLTRA™ (tarlatamab), TEZSPIRE® (tezepelumab-ekko), TEPEZZA® (teprotumumab-trbw), BLINCYTO® (blinatumomab), UPLIZNA® (inebilizumab-cdon) and TAVNEOS® (avacopan). GAAP earnings per share (EPS) increased 14% from $5.22 to $5.93, driven by higher revenues, partially offset by higher operating expenses, including an Otezla® intangible asset impairment charge of $400 million recorded during the third quarter of 2025. GAAP operating income increased from $2.0 billion to $2.5 billion, and GAAP operating margin increased 2.5 percentage points to 27.6%. Non-GAAP EPS increased 1% from $5.58 to $5.64, primarily driven by higher revenues, partially offset by higher operating expenses and a higher effective tax rate. Non-GAAP operating income increased from $4.0 billion to $4.3 billion, and non-GAAP operating margin decreased 2.5 percentage points to 47.1%. The Company generated $4.2 billion of free cash flow in the third quarter of 2025 versus $3.3 billion in the third quarter of 2024, driven by the timing of working capital items and lower interest payments, 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 in the attached reconciliations. Refer to Non-GAAP Financial Measures below for further discussion. Product Sales Performance General Medicine Repatha ® (evolocumab) sales increased 40% year-over-year to $794 million in the third quarter, primarily driven by volume growth. EVENITY ® (romosozumab-aqqg) sales increased 36% year-over-year to $541 million in the third quarter, driven by volume growth. Prolia ® (denosumab) sales increased 9% year-over-year to $1.1 billion in the third quarter, primarily driven by 14% favorable changes to estimated sales deductions, partially offset by lower net selling price. For the remainder of 2025, we expect sales erosion driven by biosimilar competition, as biosimilars have launched in the U.S. market. Rare Disease TEPEZZA ® (teprotumumab-trbw) sales increased 15% year-over-year to $560 million in the third quarter, driven by higher inventory levels and higher net selling price. KRYSTEXXA ® (pegloticase) sales increased 3% year-over-year to $320 million in the third quarter, driven by 9% volume growth and 3% higher net selling price, partially offset by 10% lower inventory levels. UPLIZNA ® (inebilizumab-cdon) sales increased 46% year-over-year to $155 million in the third quarter, primarily driven by volume growth. Year-over-year sales were impacted by the timing of shipments to our ex-U.S. partner, as shipments similar to those that occurred in the third quarter of 2024 occurred in the second quarter of 2025. Excluding these shipments, sales grew by 101% year-over-year in the third quarter. TAVNEOS ® (avacopan) sales increased 34% year-over-year to $107 million in the third quarter, driven by 66% volume growth, partially offset by 16% lower inventory levels and 10% lower net selling price. Ultra-Rare products, which consist of RAVICTI ® (glycerol phenylbutyrate), PROCYSBI ® (cysteamine bitartrate), ACTIMMUNE® (interferon gamma-1b), BUPHENYL ® (sodium phenylbutyrate) and QUINSAIR ® (levofloxacin), generated $200 million of sales in the third quarter. Sales increased 6% year-over-year for the third quarter, primarily driven by higher inventory levels. Inflammation TEZSPIRE ® (tezepelumab-ekko) sales increased 40% year-over-year to $377 million in the third quarter, driven by 48% volume growth, partially offset by lower net selling price. Otezla ® (apremilast) sales increased 4% year-over-year to $585 million in the third quarter, primarily driven by 6% volume growth and 5% favorable changes to estimated sales deductions, partially offset by 5% lower net selling price. Enbrel ® (etanercept) sales decreased 30% year-over-year to $580 million in the third quarter, primarily driven by 38% lower net selling price resulting from the impact of the U.S. Medicare Part D redesign and increased 340B Program mix, partially offset by favorable changes to estimated sales deductions and volume growth. AMJEVITA ® (adalimumab-atto)/AMGEVITA™ (adalimumab) sales decreased 7% year-over-year to $154 million in the third quarter, driven by unfavorable changes to estimated sales deductions. PAVBLU ® (aflibercept-ayyh) generated $213 million of sales in the third quarter. WEZLANA ® (ustekinumab-auub)/WEZENLA™ (ustekinumab) generated $44 million of sales in the third quarter. Oncology BLINCYTO ® (blinatumomab) sales increased 20% year-over-year to $392 million in the third quarter, driven by 31% volume growth, partially offset by lower inventory levels. Vectibix ® (panitumumab) sales increased 1% year-over-year to $284 million in the third quarter. KYPROLIS ® (carfilzomib) sales decreased 5% year-over-year to $359 million in the third quarter, driven by lower volume. LUMAKRAS ® /LUMYKRAS™ (sotorasib) sales decreased 2% year-over-year to $96 million in the third quarter. XGEVA ® (denosumab) sales were flat year-over-year at $539 million in the third quarter, as 6% favorable changes to estimated sales deductions were offset by 3% lower volume and lower inventory levels. For the remainder of 2025, we expect sales erosion driven by biosimilar competition, as biosimilars have launched in the U.S. market. Nplate ® (romiplostim) sales were flat year-over-year at $457 million in the third quarter. U.S. government orders were $90 million in Q3'25 compared to $128 million in Q3'24. Excluding these U.S. government orders, Nplate sales increased 12% year-over-year, driven by volume growth. IMDELLTRA ® (tarlatamab-dlle)/IMDYLLTRA™ (tarlatamab) generated $178 million of sales in the third quarter. Sales increased 33% quarter-over-quarter, primarily driven by volume growth. MVASI ® (bevacizumab-awwb) sales increased 9% year-over-year to $213 million in the third quarter, driven by favorable changes to estimated sales deductions. Established Products Our established products, which consist of Aranesp ® (darbepoetin alfa), Parsabiv ® (etelcalcetide), and Neulasta ® (pegfilgrastim), generated $533 million of sales in the third quarter. Sales increased 3% year-over-year for the third quarter, driven by 9% favorable changes to estimated sales deductions and 5% volume growth, partially offset by lower net selling price. Product Sales Detail by Product and Geographic Region Operating Expense, Operating Margin and Tax Rate Analysis On a GAAP basis: Total Operating Expenses increased 9% year-over-year for the third quarter. Cost of Sales as a percentage of product sales decreased 6.9 percentage points driven by lower amortization expense from the fair value step-up of inventory acquired from Horizon and lower manufacturing costs, partially offset by higher profit share expense and changes in our sales mix. Research & Development (R&D) expenses increased 31% driven by higher spend in later-stage clinical programs, including those related to MariTide, for which six global Phase 3 studies are underway. Selling, General & Administrative (SG&A) expenses increased 6% driven by higher general and administrative expenses, partially offset by lower Horizon acquisition-related expenses. Other operating expenses included the Otezla® intangible asset impairment charge of $400 million. Operating Margin as a percentage of product sales increased 2.5 percentage points in the third quarter to 27.6%. Tax Rate increased 9.3 percentage points in the third quarter due to the change in earnings mix, including lower amortization expense from the fair value step-up of inventory acquired from Horizon. On a non-GAAP basis: Total Operating Expenses increased 18% year-over-year for the third quarter. Cost of Sales as a percentage of product sales increased 0.4 percentage points driven by higher profit share expense and changes in our sales mix, partially offset by lower manufacturing costs. R&D expenses increased 31% driven by higher spend in later-stage clinical programs, including those related to MariTide, for which six global Phase 3 studies are underway. SG&A expenses increased 9% driven by higher general and administrative expenses. Operating Margin as a percentage of product sales decreased 2.5 percentage points in the third quarter to 47.1%. Tax Rate increased 4.8 percentage points in the third quarter due to the change in earnings mix. Cash Flow and Balance Sheet The Company generated $4.2 billion of free cash flow in the third quarter of 2025 versus $3.3 billion in the third quarter of 2024, driven by the timing of working capital items and lower interest payments, partially offset by higher capital expenditures. The Company declared a third quarter 2025 dividend on August 1, 2025 of $2.38 per share that was paid on September 12, 2025 to all stockholders of record as of August 22, 2025, representing a 6% increase from the same period in 2024. The Company retired $1.6 billion of debt during the third quarter of 2025 and $6.0 billion year to date. During the third quarter of 2025, there were no repurchases of shares of common stock under our stock repurchase program. Cash and cash equivalents totaled $9.4 billion and debt outstanding totaled $54.6 billion as of September 30, 2025. 2025 Guidance For the full year 2025, the Company expects: Total revenues in the range of $35.8 billion to $36.6 billion. On a GAAP basis, EPS in the range of $13.76 to $14.60, and a tax rate in the range of 14.5% to 16.0%. On a non-GAAP basis, EPS in the range of $20.60 to $21.40, and a tax rate in the range of 15.0% to 16.5%. Capital expenditures in the range of $2.2 billion to $2.3 billion. Share repurchases not to exceed $500 million. This guidance includes the estimated impact of implemented tariffs, but does not account for any tariffs or potential pricing actions announced or described but not implemented as well as any tariffs, sector specific tariffs, or pricing actions that could be implemented in the future. Third 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). MARITIME-1, a Phase 3 study of MariTide for chronic weight management, has completed enrollment of adults living with obesity or overweight, without Type 2 Diabetes (T2D). MARITIME-2, a Phase 3 study of MariTide for chronic weight management, has completed enrollment of 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, was recently initiated in 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, was recently initiated in adults living with obstructive sleep apnea not on positive airway pressure therapy and living with obesity or overweight. Part 2 of the Phase 2 chronic weight management study is ongoing in adults living with obesity or overweight, with or without T2D. Data readout is anticipated in Q4 2025. A Phase 2 study investigating MariTide for the treatment of T2D is ongoing in adults living with and without obesity. Data readout is anticipated in Q4 2025. AMG 513 A Phase 1 study of AMG 513 is enrolling adults living with obesity. Repatha In October, the Company announced that the Phase 3 VESALIUS-CV clinical trial met its dual primary endpoints demonstrating that Repatha significantly reduced the risk of major adverse CV events (MACE) in individuals without a prior history of heart attack or stroke. The landmark Phase 3 VESALIUS-CV trial enrolled over 12,000 high-risk patients, approximately 85% of whom were maintained on a high or moderate intensity low-density lipoprotein cholesterol (LDL-C) reducing therapy. Patients were followed for a median of approximately 4.5 years. The VESALIUS-CV primary endpoints were time to first occurrence of a composite of coronary heart disease (CHD) death, heart attack or ischemic stroke as well as time to first occurrence of a composite of CHD death, heart attack, ischemic stroke or any ischemia-driven arterial revascularization. The results show that the primary endpoints were both statistically and clinically significant. No new safety signals were observed. Full results from the trial will be presented at the American Heart Association Scientific Sessions (AHA) on November 8th and will be submitted for publication in a peer-reviewed journal. Results from a real-world study of patients with established atherosclerotic CV disease treated with Repatha in clinical practice will also be presented at AHA. These data will offer new insights into the effectiveness of Repatha in secondary prevention to reduce the incidence of MACE in these patients. The primary endpoint of this study was the composite of heart attack, stroke and coronary revascularization, and the secondary endpoint was a composite of heart attack, stroke and CV disease death. EVOLVE-MI, a Phase 4 study of Repatha administered within 10 days of an acute myocardial infarction to reduce the risk of CV 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 atherosclerotic CV disease and elevated Lp(a). The OCEAN(a)-PreEvent trial, a Phase 3 primary prevention CV outcomes study, was initiated and is enrolling patients with elevated LP(a) at risk for a first major CV event. Rare Disease UPLIZNA In October, additional subgroup data from the Phase 3 MITIGATE trial of UPLIZNA in IgG4-related disease (IgG4-RD), grouped by baseline characteristics and organ involvement (e.g., pancreas, kidney, bile ducts), were presented at the American College of Rheumatology Annual Meeting. These analyses showed benefits comparable to those seen in the overall trial population, supporting UPLIZNA's potential across the spectrum of IgG4-RD. U.S. Food and Drug Administration (FDA) review of the MINT Phase 3 data in patients with generalized myasthenia gravis is ongoing, with a PDUFA date of December 14, 2025. TEPEZZA A Phase 3 study of TEPEZZA in Japan has completed enrollment of patients with chronic/low clinical activity score thyroid eye disease (TED). A Phase 3 study evaluating the subcutaneous route of administration of teprotumumab is ongoing in patients with TED. TAVNEOS 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 enrolling patients with moderate-to-severe symptomatic burden and low systemic disease activity. Daxdilimab Daxdilimab is a fully human monoclonal antibody targeting immunoglobulin-like transcript 7 (ILT7). A Phase 2 study of daxdilimab is ongoing in patients with moderate-to-severe active primary discoid lupus erythematosus refractory to standard of care. A Phase 2 study of daxdilimab is ongoing in patients with dermatomyositis and antisynthetase inflammatory myositis. 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 is ongoing in patients with Sjögren's disease. 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 In October, the FDA approved TEZSPIRE for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP). 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. Rocatinlimab (AMG 451/KHK4083) Rocatinlimab is a first-in-class T-cell rebalancing monoclonal antibody that inhibits and reduces OX40-positive pathogenic T-cells. The eight study ROCKET Phase 3 program evaluating rocatinlimab in patients with moderate-to-severe atopic dermatitis (AD) has enrolled over 3,300 patients. Enrollment is now complete across all eight studies. In September, Amgen and Kyowa Kirin Co., Ltd. announced preliminary top-line results from the ASCEND study evaluating long term maintenance use of rocatinlimab with every four week and every eight-week dosing, in adults and adolescents with moderate to severe AD[1]. The ongoing ASCEND study will continue to evaluate the long-term safety profile of rocatinlimab. ROCKET ASTRO a 52-week study of rocatinlimab is complete. This study evaluated two doses of rocatinlimab (150 mg and 300 mg) as monotherapy and in combination with background low-to-medium potency topical corticosteroids and/or topical calcineurin inhibitor therapy in adolescent patients with moderate-to-severe AD. The co-primary and secondary efficacy endpoints were met. These endpoints assessed the efficacy at week 24 of rocatinlimab dosed every four weeks. Overall, safety events were consistent with other trials in the ROCKET program. A Phase 2 study of rocatinlimab is ongoing in patients with moderate-to-severe asthma. A Phase 3 study of rocatinlimab has completed enrollment of patients with prurigo nodularis. 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 systemic lupus erythematosus (SLE), with and without nephritis, and is enrolling adults with refractory rheumatoid arthritis. 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 has completed enrollment of patients with asthma. Oncology BLINCYTO / blinatumomab The dose-expansion and optimization phase of a Phase 1/2 study of subcutaneous blinatumomab in adult patients with relapsed or refractory CD19-positive Philadelphia chromosome (Ph) negative B-cell precursor acute lymphoblastic leukemia (B-ALL) is complete. The potentially registration-enabling Phase 2 portion of this study was initiated and is enrolling both adults and adolescents. 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-ALL. IMDELLTRA / tarlatamab IMDELLTRA is the first and only FDA-approved delta-like ligand 3 (DLL3) targeting BiTE molecule. In September, results from DeLLphi 303 a Phase 1b study of IMDELLTRA in combination with a PD-L1 inhibitor in the first-line maintenance setting of extensive-stage small cell lung cancer (ES-SCLC) were presented at the World Conference on Lung Cancer and simultaneously published in Lancet Oncology. The addition of IMDELLTRA to a PD-L1 inhibitor as first-line maintenance therapy for ES-SCLC demonstrated a manageable safety profile consistent with the known safety of each component, sustained disease control, and promising median overall survival of 25.3 months, supporting further investigation of this combination in the Phase 3 DeLLphi-305 study. In October, additional results from separate arms of the DeLLphi 303 Phase 1b study which evaluated IMDELLTRA in combination with platinum-based chemotherapy and a PD-L1 inhibitor in the first line setting of ES-SCLC were presented at the Annual Congress of the European Society for Medical Oncology (ESMO). IMDELLTRA in combination with first-line chemo-immunotherapy induction followed by IMDELLTRA with PD-L1 inhibitor maintenance therapy demonstrated a manageable safety profile consistent with the known safety of each component and promising initial survival outcomes. In this study median overall survival was not yet reached, the Kaplan-Meier estimate of overall survival at 12 months was 81%. These data support further investigation of this combination in the Phase 3 DeLLphi-312 study. The U.S. regulatory submission of DeLLphi 304 a global Phase 3 confirmatory study evaluating IMDELLTRA vs. standard of care in subjects with relapsed ES-SCLC after platinum-based first-line chemotherapy was accepted with a PDUFA date of December 18, 2025. Regulatory reviews are also underway in a number of additional geographies. 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 has completed enrollment of patients with first-line ES-SCLC in the maintenance setting. DeLLphi-306, a Phase 3 study of IMDELLTRA following concurrent chemoradiation therapy, is enrolling 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, is enrolling patients. 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, is enrolling 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 ES-SCLC. DeLLphi-312, a Phase 3 study of first-line IMDELLTRA in combination with carboplatin, etoposide and durvalumab, 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 castrate resistant prostate cancer (mCRPC) who have previously been treated with taxane-based chemotherapy. XALience, a Phase 3 study of xaluritamig in combination with abiraterone versus investigator's choice therapy was initiated in 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 enrolling patients with high-risk biochemically recurrent prostate cancer after definitive therapy. A Phase 1b study of xaluritamig in combination with androgen receptor pathway inhibitors was initiated and is enrolling patients with metastatic hormone-sensitive prostate cancer. Bemarituzumab Bemarituzumab is a first-in-class fibroblast growth factor receptor 2b (FGFR2b) targeting monoclonal antibody. In October, the full results from both the interim analysis and descriptive follow-up analysis of the Phase 3 FORTITUDE-101 clinical trial of bemarituzumab plus chemotherapy (mFOLFOX6) in first-line gastric cancer were presented at ESMO. The results showed: At the primary analysis bemarituzumab plus chemotherapy led to a statistically significant improvement in overall survival (OS) with a median OS of 17.9 months in the bemarituzumab + mFOLFOX6 arm versus 12.5 months in the placebo + mFOLFOX6 arm, Hazard Ratio (HR) (95%): 0.61 (0.43 - 0.86; P = 0.005). At the descriptive follow-up analysis, median OS in the bemarituzumab plus mFOLFOX6 arm was 14.5 months (95% C.I 13.0-17.9 months) while the median OS in the placebo plus mFOLFOX6 arm was 13.2 months (95% CI 10.9-14.7 months), HR (95%): 0.82 (0.62-1.08). FORTITUDE-102, a Phase 1b/3 study of bemarituzumab plus chemotherapy and nivolumab in patients with first-line gastric cancer was stopped. FORTITUDE-103, a Phase 1b/2 study of bemarituzumab plus oral chemotherapy regimens with or without nivolumab, has completed enrollment of patients with first-line gastric cancer. FORTITUDE-301, a Phase 1b/2 basket study of bemarituzumab monotherapy, is ongoing in patients with solid tumors with FGFR2b overexpression. AMG 193 AMG 193 is a first-in-class small molecule methylthioadenosine (MTA)-cooperative protein arginine methyltransferase 5 (PRMT5) inhibitor. A Phase 2 study of AMG 193 is enrolling patients with methylthioadenosine phosphorylase (MTAP)-null previously treated advanced non-small cell lung cancer (NSCLC). A Phase 1/1b/2 study of AMG 193 is enrolling 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 is enrolling patients with advanced MTAP-null thoracic malignancies. A Phase 1b study of AMG 193 in combination with other therapies is enrolling 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 enrolling patients with NSCLC, ovarian cancer, or breast cancer. Biosimilars A randomized, double-blind pharmacokinetic similarity study of ABP 206 compared with OPDIVO® (nivolumab) in patients with resected stage III or stage IV melanoma in the adjuvant setting met the primary endpoint of pharmacokinetic similarity. A randomized, double-blind comparative clinical study of ABP 206 compared with OPDIVO is enrolling patients with treatment-naïve unresectable or metastatic melanoma. A randomized, double-blind pharmacokinetic similarity study of ABP 234 compared with KEYTRUDA® (pembrolizumab) is enrolling 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 enrolling 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. Rocatinlimab, formerly AMG 451/KHK4083, is being developed in collaboration with Kyowa Kirin. 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. 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 third quarters of 2025 and 2024, in accordance with U.S. Generally Accepted Accounting Principles (GAAP) and on a non-GAAP basis. In addition, management has presented its full year 2025 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, divestitures, 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 third quarters of 2025 and 2024. 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 help millions of patients in their fight against some of the world's toughest diseases. More than 40 years ago, Amgen helped to establish the biotechnology industry and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what's known today. Amgen is advancing a broad and deep pipeline that builds on its existing portfolio of medicines to treat cancer, heart disease, osteoporosis, inflammatory diseases and rare diseases. In 2024, Amgen was named one of the "World's Most Innovative Companies" by Fast Company and one of "America's Best Large Employers" by Forbes, among other external recognitions. 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 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. or Kyowa Kirin Co., Ltd.), the performance of Otezla® (apremilast), our acquisitions of ChemoCentryx, Inc. 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. There can be no guarantee that we will be able to realize any of the strategic benefits, synergies or opportunities arising from the Horizon acquisition, and such benefits, synergies or opportunities may take longer to realize than expected. We may not be able to successfully integrate Horizon, and such integration may take longer, be more difficult or cost more than expected. 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) Casey Capparelli, 805-447-1746 (investors) 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. This guidance includes the estimated impact of implemented tariffs, but does not account for any tariffs or potential pricing actions announced or described but not implemented as well as any tariffs, sector specific tariffs, or pricing actions that could be implemented in the future. SOURCE Amgen 21% more press release views with Request a Demo