Romiplostim

AI翻译和专业人士校准，让您像巴菲特一样读财报。 会议时间：2026年2月3日 会议摘要 公司概况： 安进公司在全球范围内发现、开发、生产和销售人类治疗药物。公司专注于炎症、肿瘤/血液学、骨骼健康、心血管疾病、肾脏病和神经科学领域。公司的产品包括：恩利（Enbrel），用于治疗斑块状银屑病、类风湿性关节炎和银屑病关节炎；纽拉司亭（Neulasta），用于降低癌症患者因白细胞计数低而感染的几率；普罗力（Prolia），用于治疗患有骨质疏松症的绝经后妇女；Xgeva，用于预防骨骼相关事件；Otezla，用于治疗患有斑块状银屑病、银屑病关节炎和与白塞病相关的口腔溃疡的成年患者；阿法达（Aranesp），用于治疗低于正常水平的红细胞和贫血；KYPROLIS，用于治疗复发性或难治性多发性骨髓瘤患者；以及瑞百安（Repatha），用于降低心肌梗死、中风和冠状动脉血运重建的风险。公司还销售Nplate、Vectibix、MVASI、Parsabiv、EPOGEN、KANJINTI、BLINCYTO、Aimovig、EVENITY、AMGEVITATM、Sensipar/Mimpara、NEUPOGEN、IMLYGIC、Corlanor和AVSOLA。安进公司为医疗保健提供者提供服务，包括医生或其诊所、透析中心、医院和药房。公司通过药品批发分销商以及直接面向消费者的渠道分销其产品。公司与诺华制药公司（Novartis Pharma AG）、优时比公司（UCB）、拜耳医疗保健有限公司（Bayer HealthCare LLC）、百济神州有限公司（BeiGene, Ltd.）、礼来公司（Eli Lilly and Company）、Datos Health和Verastem, Inc. 签订了合作协议，以评估VS-6766与lumakrastm (Sotorasib)联合用于治疗KRAS G12C突变非小细胞肺癌患者。公司与协和麒麟株式会社（Kyowa Kirin Co., Ltd.）达成协议，共同开发和商业化KHK4083，这是一种已进入3期临床的抗OX40全人单克隆抗体，用于治疗特应性皮炎和其他自身免疫性疾病；并与Neumora Therapeutics, Inc. 和 Plexium, Inc. 开展研发合作。安进公司成立于1980年，总部位于加利福尼亚州千橡市。 介绍： 投资者关系副总裁Casey Capparelli介绍了电话会议并概述了问答环节的规则。 Bob Bradway主持了收益电话会议，随后Jay Bradner、Murdo Gordon和Peter Griffith进行了业绩回顾。 使用非公认会计准则（GAAP）财务措施讨论业绩，并在附带材料中提供了调整信息。 做出了前瞻性陈述，这些陈述可能会发生变化，并受到安全港声明的保护。 运营表现： 安进公司在2025年报告了强劲的运营表现，拥有14种重磅产品，其中13种实现了两位数的销售额增长，18种创下了记录结果。 2026年的关键增长领域包括Repatha、Evenity和Tezspire，以及强大的罕见病产品组合和创新的肿瘤学产品线。 Repatha，一种PCSK9抑制剂，由于其在管理LDL胆固醇和降低心血管风险方面的有效性，销售额增加了36%，超过30亿美元。 Evenity，用于治疗绝经后骨质疏松症，销售额达到21亿美元，增长了34%，市场份额为60%。 罕见病产品组合增长了14%，接近52亿美元，由Uplizna和Tepezza引领。 创新的肿瘤学产品组合和生物类似药产品组合显示了强劲的增长，对整体销售额做出了重大贡献。 财务亮点： 2025年非GAAP运营利润率为46%。 记录显示非GAAP研发支出达72亿美元。 产生了81亿美元的自由现金流，并偿还了60亿美元的债务。 计划通过股息向股东返还资本。 对2026年的预测包括总收入在370亿至384亿美元之间，非GAAP每股收益在21.60至23美元之间。 预期保持非GAAP运营利润率在45%-46%左右。 计划投入26亿美元的资本支出主要用于扩大制造能力。 研究与开发： 在2025年获得了5项关键监管批准。 推进了多个后期项目，包括MariTide用于肥胖及相关疾病，Repatha用于心血管健康，以及Uplizna用于罕见疾病。 根据临床试验结果停止了Bemarituzumab的研发。 开发了多种专注于基于肠促胰岛素和非肠促胰岛素药物的临床前项目。 对MariTide作为每月给药疗法治疗2型糖尿病和慢性体重管理的潜力充满信心。 Uplizna的作用机制针对CD19病理B细胞，在治疗其他自身免疫性疾病如CIDP方面显示出前景。 Tepezza在国际上表现出色，特别是在日本，预计今年将推动增长。 AMG 732，一种IGF-1R靶向单克隆抗体，正在进行二期研究，用于甲状腺眼病。 市场定位与竞争： MariTide被视为管理2型糖尿病和慢性体重的范式转变，提供每月、每两个月和每三个月的给药选项。 Tepezza正在将其治疗范围扩展到低临床活动评分患者，使内分泌科医生也能参与处方。 公司准备应对新兴的生物类似药的竞争，并维持其领导地位。 预计Repatha的势头将继续，VASILIS数据促进了其在一级预防患者中的使用。 Uplizna是唯一获得FDA批准用于IgG4相关疾病的治疗方法，新患者和从其他疗法转换过来的患者都对其有良好的接受度。 关键信息： 强劲的运营和财务表现：  安进公司报告了销售和利润的显著增长，重点在于保持利润率并投资于研发。 管线实力：  公司强调了其强大的研发管线，特别是在肥胖、罕见疾病和肿瘤学等领域，为安进公司的长期持续增长奠定了基础。 市场领导地位：  安进公司强调了其在治疗慢性疾病方面的领导地位，并准备应对新进入者和生物类似药的竞争。 未来增长前景：  公司对2026年的前景表示乐观，主要由Repatha、Evenity和Tezspire等关键产品及其创新的研发管线驱动。 结论 电话会议以邀请进一步的问题向Casey Capparelli和他的团队提出而结束。安进公司旨在增强其在2026年进展的信心，并激发对未来增长机会的期待。 会议原文 大家好，我是Julianne，今天由我主持安进公司2025年第四季度财报电话会议。为了避免背景噪音，所有线路都已静音。在最后一位发言人结束准备好的发言后，我们将进入问答环节。为了确保每位参会者都有机会提问，请大家在问答环节中仅提一个问题。现在，我谨代表大家欢迎投资者关系副总裁Casey Capparelli先生。Capparelli先生，请开始吧。 谢谢 Julianne。各位下午好，欢迎参加我们2025年第四季度财报电话会议。今天由 Bob Bradway 主持会议，之后 James E. Bradner、Murdo Gordon 和 Peter H. Griffith 将详细解读公司整体业绩。在今天的讨论中，我们将使用非 GAAP 财务指标来阐述公司业绩，相关调节信息已在本次会议的材料中提供。我们还会做出一些前瞻性声明，这些声明受“安全港”条款的约束。请注意，实际结果可能与前瞻性声明存在重大差异。下面请 Bob 发言。 好的，谢谢凯西。各位下午好，感谢今天拨冗参会。今天，我们将回顾安进公司2025年全年业绩，并展望2026年的发展。2025年，安进公司整体运营表现强劲，这体现在我们广泛的业务布局上。值得关注的是，我们有14款产品销售额突破10亿美元，成为重磅炸弹药物；13款产品实现了两位数的销售增长；更有18款产品创下历史新高。凭借多元化产品组合的强大实力，公司在2025年实现了营收和每股收益的双位数增长。展望2026年，我想重点介绍六个增长动力。其中，瑞百安 (Repatha)、依万奇 (Evenity) 和 TestSpire 这三款产品在2025年均实现了超过30%的同比增长。这些药物有几个共同点：首先，它们都是高效创新的疗法，能够解决重要的公共卫生需求；其次，它们在各自领域都处于领先地位；第三，尽管这些产品已是数十亿美元的全球性产品，但它们所针对的领域仍存在大量未被满足的医疗需求，数百万患者尚未得到治疗。因此，它们不仅是2026年的增长引擎，更是未来十年的增长动力。在罕见病领域，我们的产品组合在2025年创造了超过50亿美元的销售额。同样，我们许多罕见病药物仍处于生命周期的早期阶段，并在各自领域占据领先地位。增长主要得益于我们覆盖了更多患者，拓展了新的地域市场，并获批了新的适应症。随着我们持续扩大这些疗法的应用，未来还有更大的发展机遇。Uplisna就是一个例证，它在2025年获批用于治疗IgG4相关疾病和全身型重症肌无力。2025年，我们的创新肿瘤产品组合实现了11%的同比增长，这主要得益于我们的BiTE（双特异性T细胞衔接器）药物。我们对Imdeltra尤其感到兴奋，凭借其显著的生存获益，它已迅速成为二线及以上小细胞肺癌患者的标准疗法。在生物类似药领域，我们是行业领导者。自2018年首款生物类似药上市以来，我们的生物类似药产品组合已累计贡献了超过130亿美元的销售额。2025年，该业务创造了30亿美元的销售额，已成为公司重要的业绩贡献者，并有望随着下一批生物类似药的上市实现进一步增长。通过我们的研发活动，您也能体会到公司业务的深度。2026年将是严谨推进数据产出的一年，多个令人期待的二期和三期临床项目将为安进的长期增长铺平道路。我们对Meritide作为肥胖症、2型糖尿病以及肥胖相关疾病的差异化疗法，信心持续增强。在目前有众多潜在的每日口服和每周注射药物的竞争领域中，Meritide作为唯一一款处于后期开发阶段的疗法脱颖而出，有望带来变革，提供强大的疗效和良好的耐受性，且只需每月、隔月甚至每季度给药一次。除了Meritide，我们对opaziran也充满期待，它有望为脂蛋白(a)升高（一种心血管疾病的遗传性风险因素）的患者带来新的治疗选择。我们认为opaziran是巩固和拓展公司在心血管代谢疾病领域领先地位的重要机会。值得一提的是，瑞百安 (Repatha)、opaziran和Meritide将共同构成一个极具竞争力的心血管代谢药物组合，有望在未来十年乃至更长时间内，进一步扩大我们在严重慢性病治疗领域的领先优势。除了丰富的产品管线，我们对技术与生命科学的融合也充满热情。基于安进的实践，我们相信这种对融合创新的热情是恰如其分的，它将对我们药物的发现、开发和商业化方式产生深远影响。最后，我衷心感谢全球安进同事们为服务患者所做出的贡献。接下来，请杰伊介绍研发方面的最新进展。 感谢Bob，各位下午好。第四季度为我们全年的研发工作画上了一个圆满的句号，这一年我们以严谨高效的执行力，稳步推进。2025年，我们推进了多个后期阶段的项目，获得了五项重要的监管批准，并进一步充实了已上市药物的证据基础。这些成果充分体现了我们严谨的科研精神，也预示着公司未来发展的广阔前景。首先，我想谈谈Meritide，它的发展态势喜人，令人鼓舞。Maritime III期临床项目正在快速推进，研究者和受试者的参与热情都很高。我们针对慢性体重管理的两个III期研究已经完成全部患者入组，而针对动脉粥样硬化性心血管疾病（ASCVD）和心力衰竭的结局研究也进展顺利。与此同时，我们也在不断拓展Meritide在肥胖相关疾病领域的临床应用。我们已经启动了两项针对成人睡眠呼吸暂停的III期研究，涵盖了使用和未使用气道正压通气治疗的患者。总的来说，我们目前有六项Meritide的全球III期研究正在进行中，旨在构建一个全面的证据基础。此外，正如我们上个月分享的，VERITIDE II期慢性体重管理研究的第二部分已经完成。同时，我们完成了为期24周的II期II型糖尿病研究，该研究纳入了伴有和不伴有肥胖的患者。这两项研究的结果进一步增强了我们的信心，Meritide有望为肥胖、II型糖尿病以及其他肥胖相关疾病的治疗带来新的突破。我们相信Meritide有潜力为患者提供更多的治疗选择，例如每月一次或更低频率的给药方案。Meritide的显著疗效、低给药频率以及在目标剂量下的良好耐受性，有望进一步改善患者的用药体验，提高治疗的依从性，而这正是目前该领域尚未被满足的重要需求。除了肥胖和普内科领域，第四季度，Repatha在心血管健康方面也取得了重要的里程碑式进展。11月，Repatha的III期VESALIUS CV试验的完整结果在美国心脏协会科学年会上公布，并同步发表在《新英格兰医学杂志》上。这项研究纳入了超过12000名没有既往心梗或卒中病史的患者，旨在评估在优化降脂治疗（主要是他汀类药物）的基础上，使用Repatha降低低密度脂蛋白胆固醇（LDL-C）的效果。中位随访时间约为4.5年。VESALIUS CV研究表明，Repatha能够使冠心病死亡、心梗或缺血性卒中复合终点的相对风险降低25%，心梗风险降低36%，且未观察到新的安全信号。这些数据清晰地表明，使用Repatha强化降低LDL-C能够显著降低首次发生心血管事件的风险，进一步巩固了其在心血管风险全程管理中的作用。接下来，我们来谈谈olpasiran，这是一款有潜力成为同类最佳的靶向Lp(a)的小干扰RNA药物。已完成患者招募的OCEAN(a)结局研究正在持续推进。正如之前讨论的，这是一项事件驱动型研究，复合终点事件的累积速度低于最初的预期。随着研究的进展，我们将酌情更新主要分析的时间。尽管如此，我们仍然坚信olpasiran能够降低由Lp(a)升高引起的心血管风险。这种信心来自于可靠的遗传学和流行病学证据，这些证据表明Lp(a)升高是心脏病的一个独立风险因素。在罕见病领域，第四季度APLISMA在监管方面取得了重要进展。11月，欧盟委员会批准APLISMA用于治疗活动性IgG4相关疾病的成人患者。12月，美国FDA批准APLISMA用于治疗乙酰胆碱受体抗体阳性或MuSK抗体阳性的全身型重症肌无力成人患者。这些批准是基于强大的III期临床数据，这些数据表明该药具有持久的疗效，并且每六个月给药一次可以减少类固醇的使用。这项研究进一步扩展了CD19靶向B细胞清除疗法在严重自身免疫性疾病中的应用。在更广泛的B细胞清除领域，我们正在进行多项概念验证研究，并预计今年启动两项关键性研究。第一项研究针对自身免疫性肝炎患者，这是一种严重的疾病，其特征是持续的肝脏炎症，可能导致进行性瘢痕形成、肝功能丧失，最终导致肝衰竭。第二项研究针对慢性炎症性脱髓鞘性多发性神经病（CIDP），这是一种致残性免疫介导的神经病，会损害周围神经髓鞘，导致肌力下降、感觉减退，并严重影响许多患者的日常生活。APLISMA通过清除分泌自身抗体、驱动疾病的致病性B细胞，从根本上治疗这些疾病。鉴于APLISMA在其他疾病中的显著疗效，我们很高兴它能为这两种毁灭性疾病的患者带来一种有意义的新选择。此外，我们还在推进靶向CD40配体的生物疗法desodolimab，其针对干燥综合征的两项III期研究已经完成患者招募，预计将于2026年完成研究。今天，我们很高兴地宣布daxdilimab的II期临床数据取得了积极的结果。Daxdilimab是一种同类首创的浆细胞样树突状细胞清除单克隆抗体，靶向免疫球蛋白样转录本7蛋白（ILT7）。这项针对原发性盘状红斑狼疮患者的研究达到了主要终点和关键次要终点，并显示出良好的安全性。这些数据令人鼓舞，我们正在努力推进daxdilimab在该领域的后续开发。在炎症领域，我们的III期项目也在继续推进，目前正在进行慢性阻塞性肺疾病和嗜酸性粒细胞性食管炎的研究。 预计相关研究将于今年下半年完成。我们最近宣布，已决定终止与协和麒麟制药（Kewa Kirin）关于 rocotinlimab 的开发和商业化合作。 考虑到我们在四大治疗领域均有深厚的积累和广泛的布局，我们从整体产品组合的角度出发，决定将资源集中于其他后期阶段的项目。 Rocotinlimab 将交还给我们的合作伙伴协和麒麟制药，他们将全权负责该项目。接下来谈谈肿瘤领域。 去年 11 月，美国 FDA 已完全批准 IMDELTRA 用于治疗接受过铂类化疗后疾病进展或复发的广泛期小细胞肺癌成人患者。 对于这种几十年来创新寥寥的疾病，这项批准代表着一个重要的进步。 为了扩大 IMDELTRA 的影响，我们目前正在将该药物作为一线广泛期小细胞肺癌的联合疗法进行推进，在早期临床试验中，我们观察到了前所未有的生存获益。 此外，我们还在一项正在进行的 III 期研究中推进 INVELTRA 用于局限期小细胞肺癌的治疗。 看到 IMDELTRA 像 BLINCYTO 一样，逐渐成为晚期癌症治疗的标准方案，我们感到非常高兴。我们首创的 STEAP1 靶向双特异性 T 细胞衔接器 zalaritamab 在前列腺癌领域的 III 期开发工作正持续推进。 除了前列腺癌，我们最近还启动了一项针对复发或难治性尤文氏肉瘤的 Ib 期研究。 尤文氏肉瘤是一种罕见恶性肿瘤，具有高 STEAP1 表达，患者迫切需要靶向治疗。 从 IMDELTRA、BLINCYTO 到 zalaritamab，我们的双特异性 T 细胞衔接器平台持续展现出显著的长期影响。 我们仍然致力于将这些具有变革性和创新性的疗法带给癌症患者。关于肿瘤领域的最后一点： 鉴于此前公布的 FORTITUDE-101 和 FORTITUDE-102 研究结果，我们已决定不再寻求 bimirtuzumab（我们针对一线胃癌的 FGFR2b 靶向单克隆抗体）的监管批准。 尽管总体疗效未达到我们的预期，但我们在一个生物标志物定义的患者亚群中观察到了潜在的生存获益信号。 我们计划在未来与科学界分享这些发现。 与 rocotinlimab 类似，我们做出这一产品组合决策是为了将资源集中于其他后期项目。在生物类似药方面，我们分别是 Opdivo 和 Keytruda 的生物类似药候选药物 ABP-206 和 ABP-234 均已完成各自的比较临床研究的患者入组。 这为我们下一波生物类似药产品组合的持续进展提供了支持。在结束之前，正如我们在新闻稿中所述，我们正在与 FDA 就 TABNIO（我们用于治疗罕见且严重的 ANCA 相关血管炎的药物）进行持续对话。 我们将在必要时向大家更新这些讨论的进展。最后，我想说 2025 年是执行稳定、科学进展显著和决策严谨的一年。 我们预计 2026 年将是又一个执行有力、数据生成严谨和科学进步显著的一年，我们将继续推进我们强大的产品管线。 我要感谢安进公司的全体同事，感谢他们始终关注患者，并致力于推进针对严重疾病的创新药物的研发。 凭借广泛而深入的产品管线，我们已做好充分准备，实现可持续的长期增长。现在，我将把时间交给 Murdo，请他介绍商业方面的最新情况。 Murdo Gordon：非常感谢，Jay。2025年，我们实现了10%的销售增长，其中13款产品的业绩达到了两位数或更高的增长。14款产品的年销售额超过10亿美元，18款产品创下历史新高。这些成绩充分体现了我们产品组合的实力和增长潜力，也证明了我们团队在全球范围内服务患者时所展现出的卓越执行力。首先来看普通药物。瑞百安（Repatha）在2025年的销售额同比增长36%，突破30亿美元。这一优异表现主要得益于在二级和一级预防方面，患者对治疗的需求日益增长。目前，全球仍有超过1亿人需要有效的低密度脂蛋白胆固醇（LDL-C）管理。瑞百安是首个也是目前唯一一个拥有针对高风险一级和二级预防患者的临床结果数据的PCSK9抑制剂。正如Jay所提到的，具有里程碑意义的VACILIA CV试验表明，瑞百安可使高风险患者的首次主要心血管事件风险降低25%。这些数据进一步巩固了瑞百安作为PCSK9抑制剂领域循证医学证据最充分的疗法地位，并支持其在更早期、更积极的LDL-C管理中发挥关键作用。鉴于这些结果以及我们在该领域的领先地位，我们认为现在是更新临床指南和质量指标的绝佳机会。我们预计这些改变将鼓励心脏科医生和初级保健医生更积极地管理患者的LDL-C水平，并结合生活方式的改善，从而在一级和二级预防中降低心血管风险。在美国，我们通过广泛的处方药报销覆盖以及推出新的直接面向患者的项目“安进直达 (Amgen Now)”，不断提高瑞百安的可及性。“安进直达”为患者提供了一种简化的、低成本的现金支付选择，方便他们获得瑞百安。在成功推出后，我们宣布计划将该项目扩展到更多药物，并且很高兴能够通过Trump Rx提供我们的疗法，从而帮助提高美国患者的支付能力。安加维（Evenity）在2025年的销售额增长了34%，达到21亿美元。安加维仍然是唯一一种能够同时促进新骨形成并减少骨吸收的治疗方法，这种双重机制已被证明可以快速降低绝经后妇女的骨折风险。在美国，安加维的销售额增长了41%，这主要得益于现有和新处方医生用药量的增加。安加维在骨骼构建剂领域处于领先地位，市场份额超过60%，并且现在的增长速度超过了整个类别。迄今为止，大约有30万美国患者接受了安加维的治疗，仅一年内新患者就增加了33%。我们增加了投资，以加速这一增长，并预计这一趋势将持续下去。尽管取得了显著进展，但仍有近90%（约200万）患有骨折高风险的女性未得到治疗。这为安加维带来了明显的增长机会和影响。普罗力（Prolia）在2025年的销售额为44亿美元，同比增长1%。由于多种生物类似药已在全球上市，竞争加剧，我们预计2026年普罗力的销售额将加速下滑。我们的罕见病产品组合全年同比增长14%，达到近52亿美元，本季度增长19%，整个产品组合表现强劲。优普立斯（Uplizna）的销售额同比增长73%，达到6.55亿美元，反映出所有三个已批准适应症的患者需求都在增长。去年12月，优普立斯获得FDA批准用于治疗全身型重症肌无力，这对患有这种慢性衰弱性疾病的患者来说是一个重要的里程碑。无论是初治患者还是转换治疗方案的患者，早期医生的反馈都非常积极。处方医生特别指出，优普立斯针对疾病根源的上游B细胞机制、已证实的安全性以及每年两次给药的便利性都具有优势。优普立斯在IgG4相关疾病中的应用也在持续增长。自该药在美国上市以来，包括风湿病学家和胃肠病学家在内的近500名专家已经开出了优普立斯的处方。此外，优普立斯在视神经脊髓炎谱系疾病（NMOSD）领域仍然保持领先地位，并且仍然是美国治疗该疾病处方量最多的FDA批准疗法，这得益于持续的新患者增长以及治疗周期内患者的高度依从性。泰泽普（TEPEZZA）在2025年的销售额增长了3%，达到19亿美元，这主要得益于净售价的提高。自该药在美国上市以来，已有超过25,000名患者接受了治疗，并且越来越多的新老处方医生对此药表现出兴趣。我们看到内分泌科医生的处方量不断增加，并且开具该药的专家群体也在不断扩大。在日本，自上市以来，大约有1,200名患者接受了治疗，这反映出患者和处方医生对甲状腺眼病负担的认识日益提高。我们计划在2026年将泰泽普推广到更多市场，从而在全球范围内扩大这种重要疗法的可及性。他米奥（Tavneos）在2025年的销售额为4.59亿美元，同比增长62%，这主要得益于销量的强劲增长。自2021年上市以来，已有超过7,000名ANCA相关血管炎患者接受了他米奥的治疗，超过4,000名医疗专业人员开出了该疗法的处方。ANCA相关血管炎是一种严重的、可能危及生命的疾病，如果控制不当，可能导致严重的器官损害，并且目前的治疗选择有限。基于临床数据、真实世界证据及其良好的获益-风险比，我们仍然相信他米奥是一种重要且有效的药物。在炎症领域，泰泽普（Tezspire）全年销售额同比增长52%，接近15亿美元。由于其差异化的TSLP机制能够靶向驱动严重未控制哮喘的多种炎症通路，泰泽普在美国市场占据有利地位，能够惠及更多患者。 尤其是在伴有鼻息肉的慢性鼻窦炎患者中，TestBiR显著降低了手术需求，进一步验证了其在嗜酸性粒细胞疾病治疗中的价值。在重度未控制哮喘领域，TESSPIRE已成为过敏专科医生为新患者选择的首选疗法，这得益于医生对其的高度信任以及在呼吸科的持续渗透。Otezla在2026年的销售额同比增长7%，接近230亿美元。但我们预计，受美国市场不利定价以及欧盟市场仿制药上市的影响，其销售额将有所下滑。我们的创新肿瘤产品组合，包括BLINCYTO、INVELTRA、LUMICRAZ、VECTOBIX、KYPROLIS、ENDLATE和XGEVA，全年销售额达87亿美元，同比增长11%。Imdeltro全年销售额达6.27亿美元，这归功于其确凿的临床疗效以及在各类医疗机构中的快速应用。目前，美国已有超过1600家医疗机构使用Imdeltra，且主要在社区医疗中心进行给药。Imdeltra于第四季度获得美国FDA完全批准，这一批准是基于III期DELPHY-304试验的有力数据。美国国家综合癌症网络（NCCN）指南也将Imdeltra列为最高级别推荐疗法，使其成为二线治疗的标准方案，并进一步巩固了其在小细胞肺癌领域的领先地位。BLINCYTO全年销售额超过15亿美元，同比增长28%，这主要得益于其在学术和社区医疗机构的广泛应用。BLINCYTO与多药化疗联合方案已被广泛认可为治疗费城染色体阴性B细胞急性淋巴细胞白血病患者的标准疗法。我们的生物类似药产品组合再次迎来强劲增长，销售额增长37%至30亿美元。 不断扩大的生物类似药产品组合为我们带来了显著的营收增长和稳定的现金流，同时也让更多患者能够以更经济的方式获得高质量的生物制剂。作为安进安维汀（EYLEA）的生物类似药，PAV Blue继续保持增长势头，2025年销售额达到7亿美元。视网膜专家对其的接受度不断提高，他们认可该产品即用型预充式注射器的便捷性以及安进在生产和供应链方面的可靠性。2025年，我们取得了优异的成绩，重点增长品牌保持了良好的发展势头。我们期待在2026年通过安进的产品惠及更多患者。下面，有请Peter发言。 谢谢默多。我们对公司在2025年第四季度和全年的执行和业绩表现感到满意，并正按计划实现我们的长期目标。具体的财务结果请参考幻灯片34至36页。正如默多提到的，我们在整个产品组合中都实现了强劲的营收增长。2025年全年，我们的非GAAP运营利润率达到46%。我们持续投入研发管线，全年非GAAP研发支出同比增长22%，达到创纪录的72亿美元。这主要得益于我们在后期研发管线中，对众多项目加大了投入，包括对米拉替德、奥帕西兰、扎鲁胺以及罕见病领域的持续投资。此外，我们在第三和第四季度完成的多项业务发展交易，带来了约3亿美元的额外研发支出。全年非GAAP其他收入和支出为21亿美元。我们持续优化资产负债表，在2025年偿还了60亿美元的债务。我们的非GAAP税率全年同比增长1.4个百分点，达到15.9%，这主要是由于盈利结构的变化。全年我们创造了81亿美元的自由现金流，这体现了公司业务运营的良好势头以及对营运资金的严格管理，同时也保证了我们在创新方面的投入。我们正在整个价值链中利用人工智能（AI），以加速治疗药物的发现和后期开发，优化生产流程，并提升客户参与度，从而快速、大规模地提高生产效率。2025年，我们的资本支出为22亿美元，主要用于在美国各地，包括俄亥俄州、北卡罗来纳州、波多黎各、罗德岛和加利福尼亚州进行的重大投资，旨在支持我们商业化品牌的持续销量增长，并为包括米拉替德在内的管线产品上市做好准备。此外，我们通过具有竞争力的股息支付向股东回馈资本，第四季度每股派息2.38美元，比2024年增长了6%。接下来，请看幻灯片37页，我们来展望一下2026年。我们预计2026年总收入将在370亿至384亿美元之间，非GAAP每股收益将在21.6美元至23美元之间。我们的营收预期区间，反映了来自六大关键增长引擎的持续强劲表现，包括瑞百安、恩蒂蒂、特司匹尔、我们的罕见病产品组合、创新肿瘤产品以及生物类似药产品组合，这将使2026年成为公司未来增长的跳板。我们预计2026年的增长将足以抵消因地舒单抗生物类似药竞争加剧而带来的预期下降，以及2026年某些其他产品的价格下降，和340B项目利用率的持续上升所带来的影响。在预测2026年业绩时，请注意，与历史趋势一致，鉴于美国年度医疗保险周期的影响，我们预计销售额将面临季节性不利因素，这主要源于福利计划变更、保险重新验证以及患者自付费用增加。我们预计奥特兹拉和恩利在第一季度的销售额将延续其历史模式，低于后续季度。同时，第一季度还将受到地舒单抗生物类似药竞争的额外影响。此外，请注意，2025年我们库存增加了约2.5亿美元，这可能会对第一季度的销售额造成潜在影响。就公司总收入而言，我们预计第一季度将实现较低的个位数同比增长。展望全年，我们预计其他收入将在16亿至18亿美元之间，这反映了我们致力于投资最佳创新，同时在整个组织内推动卓越运营、提高效率并明确优先事项。我们预计全年非GAAP运营利润率占产品销售额的比例约为45%至46%。此项指引不包含全年可能发生的任何潜在业务发展交易。剔除2025年约3亿美元的业务发展支出，我们预计非GAAP研发费用将实现较低的个位数增长。我们将继续推进米拉替德的六项全球III期临床试验，发展其他后期资产，并投资于最前沿的创新，同时保持严格的资源配置。鉴于第一季度产品销售额的下降，我们预计第一季度的非GAAP运营利润率将是全年最低点，并与2025年大致持平。我们预计2026年非GAAP其他收入和支出约为23亿至24亿美元。我们预计非GAAP税率将在16%至17.5%之间。2026年，我们预计股票回购金额将不超过30亿美元。2026年资本支出预计约为26亿美元，这与我们优先进行资本配置，投资于公司业务并扩大生产能力以支持销量增长的策略保持一致，其中包括为米拉替德的上市做准备。我们将一如既往地专注于实现可持续的长期增长，并通过践行承诺，为患者和股东创造价值，推进在高度未满足医疗需求领域的创新，并保持严格的财务纪律。我非常感谢能与全球所有同事一道，共同服务患者。我的财务更新就到这里。接下来，我将把时间交给鲍勃，进入问答环节。 好的，谢谢彼得。我想大家现在都清楚，2025年我们保持了一贯的优良业绩，实现了年初设定的各项指标。我们有决心在2026年再创佳绩。新的一年，我们开局势头良好，对未来充满信心。朱利安，现在开始进入问答环节吧。我们非常乐意回答各位的问题。 谢谢。如果您想撤回您的问题，请按星号键加1。再次提醒，提问请按星号键加1。下面我们来听取来自瑞银金融的Michael Yee的问题。请开始。 各位好，下午好。感谢提供如此详尽的信息。尽管面临生物类似药的挑战，但公司全年业绩指引依然显示增长，这非常好。显然，生物类似药是目前大家最关心的问题。最近你们也披露了一些关于Meritide的信息。我想请教一下，考虑到目前一些公司正在公布月度给药方案，甚至是联合疗法，你们如何看待公司在肥胖症领域的整体产品组合？特别是，鉴于你们似乎非常关注Meritide，那么对于该产品组合中的其他产品，公司有何规划？谢谢。 罗伯特·A·布拉德韦：好的，谢谢你，迈克尔。我们尽力回答您的问题。刚才信号不太好，但我认为我们基本听清了您的问题。Jay，你先来吧。 好的，我很乐意。谢谢你，迈克尔。安进公司可以说是为此而生的。我们一直在多个适应症上开发Meritide，而且安进本身就是领先的心血管和呼吸系统疾病公司，Meritide在这里有诸多机会。正如大家所知，我们在肥胖症领域深耕已久，最早可以追溯到瘦素的研究阶段。自那时起，我们的新药研发领导团队一直保持稳定。在公司内部，我们还有另一款处于临床阶段的药物，名为AMG 513。该药物正在进行一期临床研究，其作用机制我们尚未对外披露。在临床前研究方面，我们还有一系列令人振奋、极具潜力的项目，包括基于肠促胰素和非肠促胰素的疗法，剂型涵盖注射剂和口服药。我们始终对外部创新持开放态度。迈克尔，我认为大家可以期待我们在这个领域展开全面竞争。好的，我们继续，下一个问题。 朱莉安：谢谢迈克尔。下面请TD Cowen的亚伦·韦伯提问，请讲。 好的，非常感谢。我有一个关于dasodilumab治疗原发性干燥综合征的问题。目前看来，研究已经完成全部入组，你们也提到下半年会完成。基于二期临床数据，你们是唯一一家同时进行系统性和症状性三期临床研究的公司。我们今年能看到数据吗？考虑到原发性干燥综合征比较复杂，二期临床数据对三期临床的预测性如何？您能否详细谈谈？谢谢。 感谢亚伦，也感谢您对tesotali的关注。这是我们产品组合中一款非常令人期待的药物，它是一种靶向CD40配体的生物疗法。长期以来，人们认为CD40通路是驱动干燥综合征炎症级联反应的关键。但难点在于，其生物学机制尚不完全明确，因此，我们针对多系统疾病采取了一种非常精准且深入的方法。正如您所提到的，我们正在进行的两个干燥综合征三期临床试验，目标人群一是中重度症状活跃的患者，目标人群二是症状负担非常重的患者。干燥综合征的药物研发一直极具挑战，但我们对这一假设非常有信心。第二项研究已经完成了患者招募，该研究针对的是症状负担为中度至重度，但全身性疾病活动度较低的患者。我们预计这些临床试验将于今年晚些时候完成，届时我们将公布信息发布计划。至于二期临床结果能否在三期临床中得到验证，这确实存在历史挑战。但这款药物在SI评分上的表现——SI评分是临床和监管机构普遍接受的审批标准——是首批能够改善该疾病领域SI评分的药物之一。因此，我们对进入三期临床试验充满信心，并期待看到最终结果。 谢谢Yaron。下面请Piper Sandler的David Amsellem提问，请讲。 大卫·阿姆塞尔姆：谢谢。我有几个关于PlozNet的问题想请教。首先，能否请您详细谈谈，IgG相关疾病的潜在患者群体是否比既往文献显示的规模更大？如果确实如此，这对PlozNet的潜在市场机会意味着什么？其次，我知道PlozNet在治疗重症肌无力(gMG)方面还处于早期阶段，能否请您介绍一下目前该产品的使用情况，以及您认为它将在竞争日益激烈的治疗方案中发挥怎样的作用？谢谢。 我分两部分来回答这个问题。Jay，你先回答第一部分，然后Murdo你补充第二部分。请开始。在医学上，有一种现象：当某种靶向疗法，一种非常有效的疗法出现后，由于对疾病的认知度提高，反而可能导致疾病的诊断率上升。如果没有有效的治疗手段，谁又会主动去诊断呢？长期来看，我们现在讨论的也可能面临类似的情况。之所以难以精确描述过去五到十年间的流行病学特征，是因为我们缺乏连贯的注册登记数据，以及合适的编码，而这些都是从电子病历数据进行分析的必要条件。所以，这个问题提得很好，但情况在不断变化，就像一个移动的靶子。未来几年，我们在这方面的认识会更加准确。Murdo，你有什么补充吗？ 穆尔多·戈登：杰伊，我觉得你描述得非常清楚。正如你所说，ICD-10编码的应用已经有大约三年时间。目前我们估计，已确诊患者人数在3.5万左右，而且正如你所说，这个数字还有增长空间。虽然文献中有提到更高的数字，但我们目前主要关注的是那些已经确诊并接受治疗的患者，并努力提高大家对这种疾病的认知度。詹姆斯，目前一切进展顺利。在IgG4相关疾病方面，Plasma的市场表现非常好。由于这种炎症会影响多个器官，因此我们看到很多不同专科的医生都在开具Plasma的处方。我们会继续努力，提高疾病认知度和诊断率。这类患者的就医过程非常复杂，因为这种疾病的症状容易与其他疾病混淆。但总的来说，进展不错，我们很高兴能帮助这些患者获得治疗，这是目前唯一一款获得FDA批准的疗法，可以有效缓解症状，并改善患者的长期健康状况，特别是对受累器官而言。关于Neplizumab和gMG（全身型重症肌无力），我们对上市初期的市场表现感到满意。戴夫，正如你所说，现在还处于上市初期，但我们很高兴的是（我在开场白中也提到过），大约一半的患者是首次使用生物制剂，另一半是从其他疗法转换过来的。正如我们之前所说，这是一个市场潜力巨大，但患者满意度仍然不高的领域，因为现有疗法存在局限性，比如给药不便、疗效持续时间不足，以及可能出现的疗效减退等问题。到目前为止，我们看到市场对Plasma的作用机制及其为患者带来的便利性表现出浓厚的兴趣。总而言之，一切顺利。我们对Aplisna以及整个罕见病产品组合都感到非常兴奋。好的，谢谢。请问下一个问题。 谢谢，David。下一个问题来自高盛的Salveen Richter。请提问，您的线路已接通。我想继续追问一下Neplinza。是什么让您对推进Neplinza在CIDP（慢性炎症性脱髓鞘性多发性神经病）的三期临床研究如此有信心？您如何看待这个适应症的市场潜力？另外，请您也谈谈Repatha。您认为默沙东的口服PCSK9抑制剂上市会对Repatha产生什么影响？你们将如何调整商业策略来应对？谢谢。这两个药物分别代表了罕见病和常见病，覆盖了市场两端。 好的，那我们先请Jay提第一个问题，然后请Murdo接上。 好的，Salveen。正如Murdo所说，我们非常看好aplisna。特别是它独特的机制，能够靶向并清除CD19阳性的致病性B细胞。大家知道，CD19这个B细胞区室，不仅在成熟B细胞上表达，就像利妥昔单抗等药物靶向的CD20一样，也在前B细胞，也就是那些更幼稚、能够扩增并产生大量自身抗体的B细胞上表达。目前，我们已经观察到aplisna在多种免疫球蛋白相关疾病中的疗效，例如IgG4相关疾病、重症肌无力等。这为我们提供了一个绝佳的机会，将它应用于更多自身抗体介导的免疫疾病，从而帮助这些重症患者。在某些情况下，CD20靶向药物已经显示出一些信号，我们计划用覆盖面更广、活性更强，且更方便的aplisna进行进一步研究。我之前提到的自身免疫性肝炎也与自身抗体相关，例如ANA、抗平滑肌抗体、抗肌动蛋白抗体和抗LC1抗体。同样，在慢性炎症性脱髓鞘性多发性神经病（CIDP）中，虽然比例较低，约5%到10%的患者也存在针对旁结蛋白的自身抗体，例如NF155、CNTM1等等。这样的例子还有很多。因此，aplisna所靶向的B细胞区室驱动的这种生物学机制，为我们提供了一个很好的机会，将B细胞靶向疗法的益处扩展到这两种疾病。Murdo？ Murdo Gordon：是的，这个市场的潜力非常可观。据估计，美国现有患者大约3万5千人，每年新增确诊病例在7千到1万人之间。我们希望能成功开发出这款药物，为这些患者带来福音。这又是一种需要大量使用类固醇的疾病，我们相信能提供更优的治疗方案。所以，我们期待临床试验能取得最佳结果。关于瑞百安（Repatha），我在开场白中已简要介绍了我们的策略。去年11月在美国心脏协会上公布的里程碑式数据，让我们备受鼓舞。现在，我们可以明确地推广瑞百安用于高风险患者以及高风险一级预防人群，以预防首次心脏病发作或首次中风。这是我们目前的工作重点，而且我们是唯一一个在药品标签上同时拥有二级预防和一级预防数据的PCSK9抑制剂。Vesalius研究的数据受到了心脏科医生和基层医生的积极评价，特别是参与试验并获得良好疗效的糖尿病患者，尤其受到基层医生的关注。因此，我们正专注于提高这些数据的认知度。瑞百安的市场准入情况良好，已被全国乃至全球的药品福利管理机构（PBM）和各大医保计划广泛列为首选药物。当然，我们也清楚，医生们对瑞百安的特性和疗效已经建立了高度信任。数百万接受过瑞百安治疗的患者，对每两周一次的注射方案接受度很高，该方案能将胆固醇降至Vesalius研究中瑞百安组达到的45毫克/分升的目标水平，从而有效降低心血管疾病风险。所以，我们有很多可以讨论的内容。我们始终认为，这个市场有足够的空间容纳其他疗法，但它们不会拥有瑞百安已经建立的数据和特性优势，我们将继续向医生和其他相关方强调这一点。好的，请问下一个问题。 谢谢 Salveen。接下来请富国银行的 Mohit Bansal 提问，请讲。 Mohit Bansal：好的，非常感谢您解答我的提问，也祝贺贵公司取得的良好进展。我想再次请教关于PCSK9的问题，特别是目前的情况。Murdo，能否请您告知，目前有多少比例的处方来自初级保健医生？结合Vesilius的数据，您认为初级保健市场的未来发展趋势如何？谢谢。 好的，谢谢 Mohit。在 Vesalius 数据推广之前，我们公布过一个数据：大约 40% 的处方来自一级预防患者，也就是尚未发生过心血管事件的患者。医生希望通过药物来降低这些患者的低密度脂蛋白胆固醇。我预计这个比例会随着时间推移而增长。坦率地说，心脏科医生也对此表现出极大的兴趣，他们对 Vesalius 数据感到非常兴奋，因为主要终点、次要终点，甚至心肌梗死亚组的结果都显示出高度一致性。而且，试验中总死亡率的表现也同样吸引了专科医生的注意。因此，心脏科医生认为这进一步肯定了他们积极治疗低密度脂蛋白胆固醇的策略。正如我之前提到的，全科医生也更倾向于在患者现有的优化他汀治疗方案中加入瑞百安（Repatha）。关于具体销售额，我们不提供产品层面的业绩指引。但我希望大家能感受到，我对瑞百安目前的发展势头感到非常振奋。我对全球团队的执行力非常满意。我们已经提前为 Vesalius 数据的推广机会增加了投资，并且预计这种势头会持续下去。好的，谢谢。下一个问题。 谢谢 Mohit。下面请 ScotiaBank 的 Louise Chen 提问，请讲。 您好，感谢您接受我的提问。我想请教一下关于TEPEZZA的问题，以及您如何看待未来潜在的竞争对手进入市场。另外，请问AMG 732在治疗TED（甲状腺眼病）方面的进展如何？谢谢。 好的，很好。我们这次还是分成两部分来讲吧。Jay，你先谈谈临床方面，然后Mirko谈谈商业方面，可以吗？ 谢谢，Louise。TEPEZZA 已经证明是一种非常重要的甲状腺眼病治疗药物。无论是在临床活动评分较高还是较低的患者群体中，我们都建立了非常强大的证据基础。我们对这些数据成果感到非常自豪，同时也看到了它对目前接受治疗的患者产生的显著积极影响。我们正在进行一项针对中重度活动性甲状腺眼病的皮下注射三期临床研究，正如之前所说，该研究已经完成全部患者招募，预计将在今年下半年完成。总而言之，TEPEZZA 是一种非常优秀的药物，并且日益成为标准疗法，帮助了大量患者，并有强大的数据作为支撑。在交给 Myrtle 之前，我简单提一下 AMG 732。感谢大家的关注。这是一种靶向 IGF-1R 的单克隆抗体，同样可以进行皮下注射。二期临床研究正在招募患者，初期主要针对中重度活动性甲状腺眼病患者。未来我们将公布更多相关信息。 好的，谢谢Jay。正如Jay所说，我们正在扩大甲状腺眼病（TED）的治疗范围，将临床活动评分（CAS）较低的患者群体纳入其中。这类患者通常由与高CAS患者不同的专科医生管理。过去，我们在眼整形外科医生和普通眼科医生中实现了非常高的渗透率。现在，我们正积极拓展处方医生群体，将内分泌科医生也纳入进来。我们于去年初进行了相关投资，目前已开始看到回报，越来越多的内分泌科医生开始开具我们的药物处方，尤其是在美国市场。我们预计，在保持高临床活动评分患者市场份额的同时，将继续扩大对低临床活动评分患者的治疗覆盖。另外，我们的国际市场拓展进展顺利，尤其是在日本的上市非常成功，产品接受度很高，高临床活动评分患者对我们的产品反响热烈。目前，我们正在全球多个市场陆续推出产品。总而言之，TEPEZZA今年将成为我们重要的增长动力。谢谢。我们进入下一个问题。 Julianne：谢谢路易丝。下面请摩根士丹利的Terence Flynn提问。 谢谢您提供提问机会。我有一个关于Miratide三期项目的问题。感谢今天提供的详细信息。我想了解一下，关于二型糖尿病心血管结局试验(CVOT)的设计，目前有什么新的进展或考虑吗？特别是对照组的设计，我知道在看到一些竞争对手的数据后，公司内部可能一直在讨论。想了解一下，目前你们对对照组有什么想法？谢谢。 好的，杰伊，你来说吧。 好的，Terrence，很高兴能和大家分享。我们对于有机会开发Miratide来治疗二型糖尿病患者感到非常激动。我们认为这款药物有望彻底改变二型糖尿病的治疗模式。回顾我的从医经历，过去我们常常使用胰岛素，但口服药物效果不佳，而且剂量调整非常繁琐。现在，我们有了一种可以每月给药一次的药物。研究显示，每两个月给药一次，在长期体重管理方面效果显著。最近，我们还提出了每季度给药一次的维持治疗方案。这确实是糖尿病管理的一个新模式。在摩根大通的会议上，我们已经分享了正在进行的二期二型糖尿病研究的主要发现。这项试验还在进行中，更重要的是，它让我们积累了低BMI患者的经验，并观察到不同剂量下的糖化血红蛋白（A1c）水平。这项试验的可靠数据为我们启动三期临床研究奠定了坚实的基础。关于这些研究的具体设计、对照组以及患者招募等细节，我们将在后续再做详细沟通。好的，谢谢。我们来看下一个问题。 谢谢Terrence。下面请摩根大通的Chris Schott提问。请讲。 好的，非常感谢。再问一个重要的问题，关于给药频率低于每月一次的情况。更长的给药间隔无疑会带来巨大优势，即使体重减轻效果略有降低，这其中可能存在某种权衡。那么，在考虑将给药周期延长至超过每月一次时，您认为需要达到怎样的疗效水平，才能确保产品在市场上具有竞争力？是否有最低疗效标准？总的来说，您对实现更长给药周期的产品有多大信心？非常感谢。 好的，这个问题很有意思。Murdo，你是否愿意谈谈你对市场的看法，以及我们为什么认为Meritide有潜力满足这一领域中日益增长的巨大未满足需求？ 好的，Bob，我来补充几句。感谢提供这次机会。目前市场上的情况很明显，大家对每周一次的GLP-1药物存在不满。口服司美格鲁肽的快速普及就充分说明了这一点，表明患者和医生都在寻求其他治疗方案。我们非常有希望提供一种能够改变现有治疗模式的疗法，正如本次会议多次提到的。具体而言，我们有机会进入目前以每周用药为主的市场，并推出每月一次的疗法，在实现相似减重效果的同时，保持良好的患者耐受性。更重要的是，对于达到理想体重的患者，可以转换为每八周或每十二周一次的给药方案，以维持体重和/或治疗带来的代谢获益。我认为这是一个非常有竞争力的方案。我们正朝着这个方向努力，并将通过多种方式收集相关数据来证实其有效性。 克里斯，不如我们请Jay也简单谈谈这方面的情况？ Chris，谢谢你的提问。不过，我想先稍微纠正一下你问题的前提。你提到降低给药频率一定会牺牲疗效，对此我们并不确定。我们观察到，绝大多数患者即使在低剂量或每季度给药的情况下，也能维持体重。在肥胖症领域，这被称为“防御性脂肪量”。避免体重反弹，表明体重重置已经成功。到目前为止，所有药物在减重方面都存在剂量范围效应，而在这里，我们可能会看到给药周期对减重产生影响，并且会根据患者的具体情况进行个体化调整。因此，我不认为降低miratide的给药频率一定会显著影响疗效。好的，谢谢。我们看下一个问题。 Julianne：谢谢Chris。下一个问题来自Evercore ISI的Umer Raffat，请提问。 各位好，感谢解答我的问题。我今天实在是很困惑，想弄清楚到底发生了什么。FDA为什么突然要求你们撤回ChemoCentryx的药物？是不是有什么诉讼或者事先的沟通？究竟是什么促使他们做出这个决定的？更具体地问，他们说有九名患者需要重新裁定，指的是26周的主要终点缓解率，还是52周的持续缓解率？我问的原因是，26周的终点本来就显示非劣效。即使重新裁定这些患者，结果应该仍然是非劣效。说实话，我今天完全摸不着头脑。 罗伯特·A·布拉德韦：好的，杰伊，你来回答这个问题。你可以先从宏观层面介绍一下 Tavneos 是什么，以及它针对的疾病。相对于我们其他的在研项目，Tavneos 目前的规模还很小，可能很多参会者对这款药不太熟悉。 好的，谢谢Umer。我先简单介绍一下背景情况。ANCA相关性血管炎是一类非常严重、罕见且具有破坏性的炎症性疾病，它主要侵犯血管，从而损害肾脏、肺、皮肤、神经甚至心脏等重要器官。在Tavneos（通用名：avacopan）上市之前，ANCA相关性血管炎的传统治疗方案毒性较大，通常采用环磷酰胺化疗，联合硫唑嘌呤和利妥昔单抗，并长期使用类固醇。长期使用类固醇非常普遍，但也带来诸多挑战，例如高血糖、肌营养不良、骨骼健康问题、情绪障碍和免疫抑制等副作用。Tavneos（avacopan）是一种口服补体C5a受体抑制剂，通过阻断补体介导的组织破坏发挥作用。我们在2022年从ChemoCentryx收购了Tavneos，当时该药已上市一年，其获批上市是基于发表在《新英格兰医学杂志》上的ADVOCATE III期临床研究结果，这项研究表明，在当时的标准化诱导治疗方案（利妥昔单抗和环磷酰胺）基础上，联合使用Tavneos，与泼尼松逐渐减量方案相比，能更有效地实现长达52周的持续缓解。正如我们之前披露的，FDA于1月16日要求我们主动撤回该药，对此我们感到非常意外。FDA的担忧主要集中在ChemoCentryx对331名患者中9名患者的主要终点结果进行重新评估的流程上。目前我们正在与FDA进行沟通，并将积极解答他们提出的问题。好的，我们进入下一个问题。 谢谢，Umer。下面请Wolfe Research的Alex Hammond提问。请讲。 各位好，感谢提问。Pav Lu本季度表现强劲。下半年其他厂商将推出生物类似药，公司打算如何保持领先地位？能否请就今年的增长预期给出更明确的指引？ 罗伯特·A·布拉德韦：好的，亚历山大，显然我们不会针对单一产品提供指引。默多，请你介绍一下我们帕妥珠单抗生物类似药目前为止的强劲表现。 Murdo Gordon：是的。我认为到目前为止，我们做得不错的一点是，已经与最大的几家全国性视网膜专科医生集团建立了良好的合作关系。我想说的是，他们通常倾向于选择能够帮助他们有效管理患者的产品。我们相信我们的设备在这方面做得很好。显然，我们目前正在有效地与原研产品竞争。而且，鉴于我们在生物类似药方面拥有丰富的经验，无论何时有其他竞争者进入市场，我们都有信心能够有效应对。好的。时间差不多到了，已经接近三十分钟了。我们再提最后一个问题。和往常一样，如果这次电话会议中还有问题没有解答，Casey和他的团队会随时为大家提供后续支持。Julian，最后一个问题。 朱丽安：谢谢亚历克斯。最后一个问题来自伯恩斯坦的考特尼·布林。请提问。 好的，Courtney。太棒了，非常感谢您抽出时间。我们回到Maritide的话题，考虑到维持治疗以及减少给药频率的可能性，您认为这款产品在市场中应该扮演什么角色？它是否只适用于Maritide治疗后的体重维持？或者，我们应该如何看待转换用药的市场机会？未来，您会提供哪些数据来支持该产品的市场定位？谢谢。 Robert A. Bradway：嗯，我想大家可能对这个很感兴趣。Murdo，你现在有什么想法要分享吗？ 谢谢 Courtney。很明显，正如我们多次强调的，我再重申一遍，我们的产品将彻底改变体重管理、糖尿病、动脉粥样硬化性心血管疾病和心力衰竭的治疗模式，是颠覆性的。我们认为，无论是帮助患者达到初期体重目标，还是为需要长期治疗的患者，这款产品都能提供有效的解决方案。Maritide 的独特之处在于，它能提供一种便捷、耐受性良好、疗效显著的治疗方案，给药周期灵活，可以是每月一次、每八周一次，甚至每季度一次。我们认为这非常令人振奋。当然，正如您所暗示的，可能还有一些正在接受其他疗法的患者，他们会希望转用像 Maritide 这样更便捷、耐受性更好的产品。所以，答案是以上所有情况都有可能。好的。再次感谢各位的关注，也感谢大家参加本次电话会议。我再次强调，如果本次会议未能解答您的问题，请直接联系 Casey 和他的团队。同时，我希望今天的会议能让大家对我们迈向 2026 年的势头充满信心。我再次重申，我们对即将到来的这一年充满期待。正如 Peter 所描述的，我们视今年为安进公司未来增长的跳板。我们对目前所拥有的优势充满信心，并期待在今年与大家分享更多进展。谢谢大家。 安进公司2025年第四季度财报电话会议到此结束。请各位挂断。 2026年1月美股公司电话会议和其他会议: Visa（V）股价大涨3.73%，稳定币结算规模已达到约 46 亿美元的年化水平 怡安保险（AON）第四季度盈利超出预期，连续三个季度表现优异 苹果（AAPL）业绩创新高却遇芯片困局：产能受限成本涨，下季增长或放缓 Meta（META）电话会：推荐系统正在被大模型重写，没有智能眼镜的未来“难以想象” 特斯拉（TSLA）Q4盈利高于预期，史上首次年度营收下滑，开始局部真正无人驾驶，投资xAI 20亿，Cybecab和机器人待量产 微软（MSFT）甩出3nm自研AI芯片！算力超10PFLOPS，干翻AWS谷歌 联合健康集团（UNH）是医保费率风暴中“最强生存者”，但行业整体风险加剧 瑞安航空（RYAAY）Q3净利降22%，燃料套保与强劲现金储备支撑未来发展及回购计划 英特尔（INTC）四季度财报后股价暴跌17%，业绩指引疲软与供应短缺成主因 台积电（TSM）变成美积电！转移40%产能，半导体市场预测现分歧 领航增长：GE航空（GE）2025年订单激增74%，2026年EPS指引近15%增长 第一西方金融公司（MYFW）：四季度盈利提升，设定1%资产回报率（ROA）新目标 创纪录业绩叠加百亿增长蓝图，金德摩根（KMI）股价应声涨近4%领跑天然气赛道 S&T Bancorp（STBA）股价现涨2.93%，财报电话会议亮点：利润与信贷清理 奈飞（NFLX）移动版 2026 年将拥抱 TikTok 模式：垂直视频流抢占每一秒注意力 Progress Software（PRGS）一度涨13.08%，第四季度盈利超预期，2026年业绩指引强劲 PNC金融服务集团（PNC）股价上涨3.79%，报告2025年营收和盈利创历史新高 美国制商银行（MTB）2025年财报电话会议：创纪录盈利、股息提升11%及2026年增长战略展望 道富银行（STT）预计，随着人工智能和数字化转型的加速，2026年费用收入将增长4-6%，营业杠杆将增加100个基点以上 Bank7（BSVN）股价上涨2.45%，公司对来年的前景感到乐观，这得益于强劲的本地市场势头和严谨的业务实践 安进（AMGN）摩根大通会议展望：聚焦六大增长引擎与肥胖症、心血管重磅管线新突破 摩根大通（JPM）组建新量化团队，迎战非银行巨头并发力电子交易 一文明晰 AMD CES 2026 布局：演讲全文与重点解读 CES 2026：9亿美元！英特尔旗下Mobileye（MBLY）宣布收购人形机器人公司，加码物理AI 财报表现强劲，应用数字公司（APLD）周四大涨12%，带动加密矿企板块普涨 AZZ（AZZ）股价大涨6.56%，受Q3业绩和展望推动 英伟达（NVDA）展望CES 2026：三大计算转型驱动未来，数据中心需求激增 英伟达（NVDA）CES 财务分析师问答会 Penguin Solutions（PENG）盘后大涨6.68%，公司正专注于企业级AI应用 盘后暴涨62.59%！礼来拟超10亿美元收购Ventyx（VTYX），重磅交易点燃市场 新年伊始，燃气轮机供应商 GE Vernova（GEV）拿下重大风电合同，股价上涨3.98% 半导体行业领涨，科磊（KLAC）股价单日飙升4.89%，AI与高性能计算需求持续强劲 更多想追踪的公司电话会议请在下方留言：） 美股投资交流群开放申请！ 获取美股公司财报&电话会议翻译。 与高手一起挖掘美股机会、交流投资心得！ 立即添加OBO小助手，审核入群 为确保群质量，请向小助手提供您的美股交易凭证 （可打码遮盖敏感信息） 或说明您想了解的美股相关信息 点击下方阅读原文， 浏览各大上市公司电话会议和焦点新闻内容 *如加载缓慢请用默认浏览器打开

THOUSAND OAKS, Calif., Feb. 3, 2026 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced financial results for the fourth quarter and full year of 2025 versus the comparable periods in 2024. "Amgen delivered strong performance in 2025, with double-digit growth in revenues and earnings per share. We enter 2026 with momentum across a broad portfolio of medicines and a clear path towards advancing innovative therapies to deliver sustained long-term growth," said Robert A. Bradway, chairman and chief executive officer. Key results include: For the fourth quarter, total revenues increased 9% to $9.9 billion in comparison to the fourth quarter of 2024. Product sales grew 7%, driven by 10% volume growth, partially offset by 4% lower net selling price. For the full year, total revenues increased 10% to $36.8 billion in comparison to the full year of 2024. Product sales grew 10%, driven by 13% volume growth, partially offset by 3% lower net selling price. Eighteen products achieved record sales for the full year. Fourteen products exceeded one billion dollars in annual sales. Thirteen products delivered at least double-digit sales growth for the full year. GAAP earnings per share (EPS) increased 111% from $1.16 to $2.45 for the fourth quarter, driven by higher revenues and lower net unrealized losses on equity investments, partially offset by higher operating expenses. For the full year, GAAP EPS increased 88% from $7.56 to $14.23, driven by higher revenues and net unrealized gains on our BeOne Medicines Ltd. (BeOne) equity investment, partially offset by higher operating expenses, including Otezla® (apremilast) intangible asset impairment charges of $1.2 billion recorded in 2025, following the selection of Otezla® for Medicare price setting, as part of the Inflation Reduction Act (IRA). For the fourth quarter, GAAP operating income increased from $2.3 billion to $2.7 billion, and GAAP operating margin increased 2.5 percentage points to 29.0%. For the full year, GAAP operating income increased from $7.3 billion to $9.1 billion, and GAAP operating margin increased 3.1 percentage points to 25.8%. Non-GAAP EPS remained relatively unchanged from $5.31 to $5.29 for the fourth quarter as higher operating expenses were partially offset by higher revenues. For the full year, non-GAAP EPS increased 10% from $19.84 to $21.84, driven by higher revenues, partially offset by higher operating expenses. For the fourth quarter, non-GAAP operating income remained relatively unchanged at $4.0 billion, and non-GAAP operating margin decreased 3.5 percentage points to 42.8%. For the full year, non-GAAP operating income increased from $15.0 billion to $16.2 billion, and non-GAAP operating margin decreased 0.8 percentage points to 46.1%. The Company generated $8.1 billion of free cash flow for the full year of 2025 versus $10.4 billion for the full year of 2024, driven by timing of working capital, primarily collections and higher capital expenditures, partially offset by business performance and lower interest payments. References in this release to "non-GAAP" measures, measures presented "on a non-GAAP basis," "free cash flow" (computed by subtracting capital expenditures from operating cash flow), "EBITDA, or earnings before interest, taxes, depreciation and amortization" (computed by adding interest expense, provision for income taxes, and depreciation and amortization expense to GAAP net income) and "debt leverage ratio" (calculated as the ratio of GAAP total debt to EBITDA) refer to non-GAAP financial measures. Adjustments to the most directly comparable GAAP financial measures and other items are presented on the attached reconciliations. Refer to Non-GAAP Financial Measures below for further discussion. Product Sales Performance General Medicine Repatha® (evolocumab) sales increased 44% year-over-year to $870 million in the fourth quarter, driven by 31% volume growth, 8% higher net selling price, and higher inventory levels. Sales increased 36% for the full year, driven by volume growth. For 2026, we expect net selling price to decline by roughly mid-single-digits. EVENITY® (romosozumab-aqqg) sales increased 39% year-over-year to $599 million in the fourth quarter and 34% for the full year, primarily driven by volume growth. Prolia® (denosumab) sales decreased 10% year-over-year to $1.1 billion in the fourth quarter, driven by 8% lower net selling price and decreased volume. Sales increased 1% for the full year, primarily driven by 2% volume growth and 2% favorable changes to estimated sales deductions, partially offset by lower net selling price. For 2026, we expect accelerated sales erosion driven by increased competition, as multiple biosimilars have launched globally. Rare Disease TEPEZZA® (teprotumumab-trbw) sales decreased 1% year-over-year to $457 million in the fourth quarter, primarily driven by 13% lower inventory levels and unfavorable changes to estimated sales deductions, partially offset by 11% volume growth and higher net selling price. Sales increased 3% for the full year, primarily driven by higher net selling price. KRYSTEXXA® (pegloticase) sales increased 26% year-over-year to $435 million in the fourth quarter, driven by higher inventory levels, higher net selling price, and volume growth. Sales increased 13% for the full year, driven by volume growth and higher net selling price. UPLIZNA® (inebilizumab-cdon) sales increased 131% year-over-year to $233 million in the fourth quarter and 73% for the full year, primarily driven by volume growth. TAVNEOS® (avacopan) sales increased 88% year-over-year to $152 million in the fourth quarter, primarily driven by 69% volume growth and 18% higher inventory levels. Sales increased 62% for the full year, driven by volume growth, partially offset by lower net selling price. Ultra-Rare products generated $157 million of sales in the fourth quarter. Sales decreased 27% year-over-year for the fourth quarter and 5% for the full year, primarily driven by generic competition for RAVICTI. For 2026, we expect continued RAVICTI sales erosion driven by generic competition. Inflammation TEZSPIRE® (tezepelumab-ekko) sales increased 60% year-over-year to $474 million in the fourth quarter, primarily driven by 51% volume growth, and to a lesser degree, higher inventory levels and favorable changes to estimated sales deductions. Sales increased 52% for the full year, driven by volume growth. Otezla® (apremilast) sales were flat year-over-year at $625 million in the fourth quarter. Sales increased 7% for the full year, primarily driven by 3% volume growth and 2% favorable changes to estimated sales deductions. Enbrel® (etanercept) sales decreased 48% year-over-year to $532 million in the fourth quarter, primarily driven by 35% lower net selling price resulting from the impact of the U.S. Medicare Part D redesign and increased 340B Program mix, and 17% unfavorable changes to estimated sales deductions. Sales decreased 33% for the full year, primarily driven by 36% lower net selling price resulting from increased 340B Program mix, the impact of the U.S. Medicare Part D redesign and higher commercial discounts, partially offset by 4% higher volume. We expect Enbrel and Otezla, and to a lesser extent KRYSTEXXA, TEZSPIRE and Repatha, to follow the historical pattern of lower sales in the first quarter relative to subsequent quarters, in part due to the impact of benefit plan changes, insurance reverification and increased co-pay expenses as U.S. patients work through deductibles. AMJEVITA® (adalimumab-atto)/AMGEVITA™ (adalimumab) sales decreased 41% year-over-year to $174 million in the fourth quarter, primarily driven by lower volume. Sales decreased 22% for the full year, driven by lower volume and lower net selling price. PAVBLU® (aflibercept-ayyh) generated $258 million of sales in the fourth quarter and $700 million for the full year. Sales increased 21% quarter-over-quarter, primarily driven by volume growth. WEZLANA® (ustekinumab-auub)/WEZENLA™ (ustekinumab) generated $44 million of sales in the fourth quarter and $273 million for the full year. Oncology BLINCYTO® (blinatumomab) sales increased 8% year-over-year to $413 million in the fourth quarter, driven by 5% higher inventory levels and higher net selling price. Sales increased 28% for the full year, driven by volume growth. Vectibix® (panitumumab) sales increased 30% year-over-year to $319 million in the fourth quarter, driven by 23% volume growth, and to a lesser degree, higher net selling price and higher inventory levels. Sales increased 12% for the full year, primarily driven by volume growth. KYPROLIS® (carfilzomib) sales decreased 6% year-over-year to $351 million in the fourth quarter and 6% for the full year, primarily driven by lower volume. LUMAKRAS®/LUMYKRAS™ (sotorasib) sales increased 8% year-over-year to $92 million in the fourth quarter, primarily driven by 22% volume growth, partially offset by 9% lower net selling price and 6% lower inventory levels. Sales increased 4% for the full year, driven by 13% volume growth, partially offset by lower net selling price. XGEVA® (denosumab) sales decreased 20% year-over-year to $447 million in the fourth quarter and 6% for the full year, primarily driven by lower volume. For 2026, we expect accelerated sales erosion driven by increased competition, as multiple biosimilars have launched globally. Nplate® (romiplostim) sales increased 14% year-over-year to $385 million in the fourth quarter, primarily driven by 9% volume growth and 4% higher inventory levels. Sales increased 5% for the full year, driven by volume growth. U.S. government orders were $90 million in 2025 compared to $128 million in 2024. Excluding these U.S. government orders, Nplate sales increased 8% for the full year, driven by volume growth. IMDELLTRA® (tarlatamab-dlle)/IMDYLLTRA™ (tarlatamab) generated $234 million of sales in the fourth quarter and $627 million for the full year. Sales increased 31% quarter-over-quarter, driven by volume growth. MVASI® (bevacizumab-awwb) sales increased 9% year-over-year to $188 million in the fourth quarter, primarily driven by 15% favorable changes to estimated sales deductions, and to a lesser degree, higher net selling price and higher inventory levels, partially offset by lower volume. Sales increased 6% for the full year, driven by favorable changes to estimated sales deductions and higher net selling price, partially offset by lower volume. Established Products Our established products, which consist of Aranesp® (darbepoetin alfa), Parsabiv® (etelcalcetide), and Neulasta® (pegfilgrastim), generated $554 million of sales in the fourth quarter. Sales increased 15% year-over-year for the fourth quarter, driven by higher net selling price and favorable changes to estimated sales deductions. Sales increased 2% for the full year, driven by 7% favorable changes to estimated sales deductions, 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 5% year-over-year for the fourth quarter and increased 6% for the full year. Cost of Sales as a percentage of product sales decreased 3.9 percentage points for the fourth quarter and decreased 5.9 percentage points for the full year, driven by lower amortization expense from acquisition-related assets, including Horizon-acquired inventory, and lower manufacturing costs, partially offset by higher profit share expense and changes in our sales mix. Research & Development (R&D) expenses increased 24% for the fourth quarter primarily driven by higher spend in the later-stage clinical programs, including MariTide, and in the research and early pipeline, including business development activities in the fourth quarter of 2025. R&D expenses increased 22% for the full year driven by higher spend in the later-stage clinical programs, including MariTide, and in the research and early pipeline, partially offset by lower spend in marketed product support. This increase includes the impact of business development activities in 2025. Selling, General & Administrative (SG&A) expenses increased 4% for the fourth quarter driven by higher commercial product-related expenses, partially offset by lower Horizon acquisition-related expenses and lower general and administrative expenses. SG&A expenses decreased 1% for the full year driven by lower Horizon acquisition-related expenses and lower amortization expense from acquisition-related assets, partially offset by higher general and administrative expenses, including technology-related spend. Other operating expenses for the full year included Otezla® intangible asset impairment charges of $1.2 billion, following the selection of Otezla® for Medicare price setting, as part of the Inflation Reduction Act (IRA). Operating Margin as a percentage of product sales increased 2.5 percentage points to 29.0% for the fourth quarter and increased 3.1 percentage points to 25.8% for the full year. Tax Rate decreased 7.8 percentage points for the fourth quarter and increased 2.8 percentage points for the full year. The fourth quarter tax rate decrease was due to the prior-year deferred tax adjustments associated with the U.S. tax on the earnings of our foreign subsidiaries, partially offset by the change in earnings mix, including lower amortization expense from the fair value step-up of inventory acquired from Horizon as compared to the prior year. The full year tax rate increase was due to the change in earnings mix, including the net unrealized gains on our equity investments compared to net unrealized losses on equity investments in the prior year, partially offset by the prior-year deferred tax adjustments associated with U.S. tax on the earnings of our foreign subsidiaries and the current year Otezla® intangible asset impairment charges and related tax impacts. On a non-GAAP basis: Total Operating Expenses increased 16% year-over-year for the fourth quarter and increased 12% for the full year. Cost of Sales as a percentage of product sales increased 1.5 percentage points for the fourth quarter and increased 0.4 percentage points for the full year, driven by higher profit share expense and changes in our sales mix, partially offset by lower manufacturing costs. R&D expenses increased 26% for the fourth quarter driven by higher spend in the later-stage clinical programs, including MariTide, and in the research and early pipeline, including business development activities in the fourth quarter of 2025. R&D expenses increased 22% for the full year driven by higher spend in the later-stage clinical programs, including MariTide, and in the research and early pipeline, partially offset by lower spend in marketed product support. This increase includes the impact of business development activities in 2025. SG&A expenses increased 6% for the fourth quarter driven by higher commercial product-related expenses, partially offset by lower general and administrative expenses. SG&A expenses increased 2% for the full year driven by higher general and administrative expenses, including technology-related spend. Operating Margin as a percentage of product sales decreased 3.5 percentage points for the fourth quarter to 42.8% and decreased 0.8 percentage points to 46.1% for the full year. Tax Rate increased 1.6 percentage points for the fourth quarter and increased 1.4 percentage points for the full year. The fourth quarter tax rate increase was primarily due to prior year net favorable items as compared to the current year. The full year tax rate increase was due to the change in earnings mix and prior year net favorable items as compared to the current year. Cash Flow and Balance Sheet The Company generated $1.0 billion of free cash flow in the fourth quarter of 2025 versus $4.4 billion in the fourth quarter of 2024, driven by timing of working capital, primarily collections, timing of tax payments and higher capital expenditures, partially offset by business performance. The Company generated $8.1 billion of free cash flow for the full year of 2025 versus $10.4 billion in 2024. The Company declared a fourth quarter 2025 dividend on October 31, 2025 of $2.38 per share that was paid on December 12, 2025 to all stockholders of record as of November 21, 2025, representing a 6% increase from the same period in 2024. The Company retired $6.0 billion of debt for the full year of 2025. During the fourth quarter and full year of 2025, there were no repurchases of shares of common stock under our stock repurchase program. Cash and cash equivalents totaled $9.1 billion and debt outstanding totaled $54.6 billion as of December 31, 2025. Debt leverage was approximately 3.2 times EBITDA as of December 31, 2025. 2026 Guidance For the full year 2026, the Company expects: Total revenues in the range of $37.0 billion to $38.4 billion. On a GAAP basis, EPS in the range of $15.45 to $16.94, and a tax rate in the range of 15.5% to 17.0%. On a non-GAAP basis, EPS in the range of $21.60 to $23.00, and a tax rate in the range of 16.0% to 17.5%. Capital expenditures to be approximately $2.6 billion. Share repurchases not to exceed $3 billion. Fourth 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, is ongoing in adults living with obesity or overweight, without Type 2 diabetes (T2D). MARITIME-2, a Phase 3 study of MariTide for chronic weight management, is ongoing in adults living with obesity or overweight, with T2D. MARITIME-CV, a Phase 3 study of MariTide on cardiovascular (CV) outcomes, is enrolling adults living with established atherosclerotic cardiovascular disease and obesity or overweight. MARITIME-HF, a Phase 3 study of MariTide on reduction of heart failure events and cardiovascular risk, is enrolling adults living with heart failure with preserved or mildly reduced ejection fraction and obesity. MARITIME-OSA-1, a Phase 3 study of MariTide, is enrolling adults living with obstructive sleep apnea on positive airway pressure therapy and living with obesity or overweight. MARITIME-OSA-2, a Phase 3 study of MariTide, is enrolling adults living with obstructive sleep apnea not on positive airway pressure therapy and living with obesity or overweight. Part 2 of the Phase 2 chronic weight management study, an exploratory evaluation of MariTide treatment for an additional 52 weeks in people who lost at least 15% of their body weight in the 52-week Part 1 of the Phase 2 chronic weight management study is complete. Key findings include: The large majority of participants maintained the weight loss achieved in Part 1 for an additional 52 weeks on a lower monthly dose or quarterly dose of MariTide. The second year of MariTide treatment was very well tolerated, including at quarterly doses, with a very low incidence of nausea and vomiting and no new safety signals observed. Improvements in cardiometabolic parameters were sustained with MariTide at effective maintenance doses for a full second year. A Phase 2 study of MariTide for the treatment of T2D in adults living with and without obesity has completed the 24-week timepoint. Key findings include: Robust and clinically meaningful reduction in both hemoglobin A1c (HbA1c) and weight with monthly MariTide at 24 weeks. In line with results seen in the T2D population in Part 1 of the Phase 2 chronic weight management study, at 24 weeks. Safety and tolerability profile consistent with the GLP-1 class. The most common side effects were gastrointestinal-related, predominantly mild-to-moderate in nature, and occurred primarily during dose escalation. Favorable improvement in cardiometabolic parameters. The Company expects to initiate Phase 3 studies of MariTide in people living with T2D in 2026. AMG 513 A Phase 1 study of AMG 513 is enrolling adults living with obesity. Repatha In November 2025, results from the landmark Phase 3 VESALIUS-CV clinical trial of more than 12,000 patients with atherosclerosis or diabetes without a prior heart attack or stroke were presented at the American Heart Association Scientific Sessions and simultaneously published in the New England Journal of Medicine. In this study, Repatha: Demonstrated a 25% relative reduction in the risk of a composite of coronary heart disease death, heart attack or ischemic stroke (3-P MACE). Demonstrated a 19% reduction in a broader composite that also included any ischemia-driven arterial revascularization (4-P MACE). Reduced the risk of heart attack by 36%. Further analysis from VESALIUS-CV will be presented on the subgroup of patients without significant atherosclerosis at the upcoming American College of Cardiology in March 2026. EVOLVE-MI, a Phase 4 study of Repatha initiated 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 is enrolling patients with elevated Lp(a) at risk for a first major CV event. Rare Disease UPLIZNA In November, the European Commission approved UPLIZNA for the treatment of adults with active immunoglobulin G4-related disease (IgG4-RD). In December, the U.S. Food and Drug Administration (FDA) approved UPLIZNA for the treatment of generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) and anti-muscle specific tyrosine kinase (MuSK) antibody positive. The Company expects to initiate Phase 3 studies of UPLIZNA in patients with autoimmune hepatitis and in patients with chronic inflammatory demyelinating polyneuropathy in 2026. TEPEZZA A Phase 3 study of TEPEZZA in Japan is ongoing in 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. Study completion is expected in H2 2026. TAVNEOS TAVNEOS (avacopan) was approved by the FDA in October 2021 for the adjunctive treatment of adult patients with severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (AAV) in combination with standard therapy including glucocorticoids. TAVNEOS was developed by ChemoCentryx, Inc. Amgen acquired ChemoCentryx in October 2022, after TAVNEOS had been on the market for a year. On January 16, 2026, the U.S. Food and Drug Administration (FDA) requested that ChemoCentryx voluntarily withdraw TAVNEOS from the U.S. market. The FDA raised concerns about the process followed by ChemoCentryx to re-adjudicate primary endpoint results for 9 of the 331 patients in its pivotal clinical trial. Hepatotoxicity, which is a known infrequent risk of TAVNEOS treatment for AAV, was also raised in the context of the benefit-risk profile of the medicine. Amgen is not aware of any issue with the underlying patient data from the ChemoCentryx clinical trial. And after review of the relevant clinical data and years of real-world evidence, Amgen is confident that TAVNEOS demonstrates effectiveness and a favorable benefit–risk profile. On January 28, 2026, following FDA regulatory process, Amgen informed the Agency that it did not intend to withdraw TAVNEOS from the market. Amgen is evaluating next steps with the FDA to determine a path forward, while keeping patient safety, needs and support at the forefront. 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 has completed enrollment of patients with moderate to high symptom burden with low systemic disease activity. Completion of both studies is expected in H2 2026. Daxdilimab Daxdilimab is a first-in-class plasmacytoid dendritic cell (pDC) depleting monoclonal antibody targeting immunoglobulin-like transcript 7 (ILT7). A Phase 2 study of daxdilimab in adult patients with moderate-to-severe primary discoid lupus erythematosus (DLE) is complete. The study met the primary endpoint of mean change in the Cutaneous Lupus Erythematosus Disease Area and Severity Index - Activity (CLASI-A) score from baseline to week 24, demonstrating statistically significant improvements in disease activity with both doses tested. The study met the key secondary endpoint of clinical response by CLASI-A 50 and by the Cutaneous Lupus Activity Investigator's Global Assessment CLA-IGA 0/1, at week 24 with both doses tested. Daxdilimab showed an acceptable safety and tolerability profile. A Phase 2 study of daxdilimab in 12 patients with dermatomyositis (DM) and antisynthetase inflammatory myositis (ASIM) is complete. Total Improvement Score (TIS) and Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) showed positive trends, but the sample size was too limited to assess efficacy. Daxdilimab showed an acceptable safety and tolerability profile. 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 Two Phase 3 studies of TEZSPIRE are enrolling adults with moderate to very severe chronic obstructive pulmonary disease (COPD) and a BEC ≥ 150 cells/µl. A Phase 3 study of TEZSPIRE is ongoing in patients with eosinophilic esophagitis. Study completion is expected in H2 2026. Rocatinlimab (AMG 451/KHK4083) Rocatinlimab is a first-in-class T-cell rebalancing monoclonal antibody that inhibits and reduces OX40-positive pathogenic T-cells. As part of ongoing portfolio prioritization, the Company will terminate the rocatinlimab development and commercialization collaboration with Kyowa Kirin, subject to Hart-Scott-Rodino review. Kyowa Kirin will assume ownership of and responsibility for the program. The Company will provide certain transition services to Kyowa Kirin. 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 is ongoing in patients with asthma. Study completion is expected in H1 2026. Oncology BLINCYTO / blinatumomab A potentially registration-enabling Phase 2 study of subcutaneous blinatumomab is enrolling both adults and adolescents with relapsed or refractory CD19-positive Philadelphia chromosome (Ph) negative B-cell precursor acute lymphoblastic leukemia (B-ALL). 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. A Phase 1b/2 study of subcutaneous blinatumomab was initiated and is enrolling pediatric patients with relapsed / refractory and minimal residual disease positive (MRD+) B-ALL. IMDELLTRA / tarlatamab IMDELLTRA is the first and only FDA-approved delta-like ligand 3 (DLL3) targeting BiTE molecule. In November, the FDA granted full approval to IMDELLTRA for the treatment of adult patients with extensive stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy. Additional Regulatory reviews are underway in multiple additional geographies including the European Union, China, and Japan. The Company is advancing a comprehensive, global clinical development program across extensive-stage (ES) and limited-stage (LS) SCLC: DeLLphi-303, a Phase 1b study of IMDELLTRA in combination with a programmed cell death protein ligand-1 (PD-L1) inhibitor, carboplatin and etoposide or separately in combination with a PD-L1 inhibitor alone, is ongoing in patients with first-line ES-SCLC. DeLLphi-305, a Phase 3 study of IMDELLTRA and durvalumab is ongoing in first-line ES-SCLC in the maintenance setting. DeLLphi-306, a Phase 3 study of IMDELLTRA following concurrent chemoradiation therapy, 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 second-line or later ES-SCLC. DeLLphi-312, a Phase 3 study of IMDELLTRA in combination with carboplatin, etoposide and durvalumab, is enrolling patients with first-line ES-SCLC. 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 is enrolling patients with chemotherapy-naïve mCRPC. A Phase 1 study of xaluritamig monotherapy and xaluritamig in combination with abiraterone is ongoing in patients with mCRPC who have not yet received taxane-based chemotherapy. This study is also ongoing in patients with mCRPC who have previously received taxane-based chemotherapy in a fully outpatient treatment setting to further improve administration convenience. A Phase 1b study of neoadjuvant xaluritamig therapy prior to radical prostatectomy is enrolling patients with newly diagnosed localized intermediate or high‐risk prostate cancer. A Phase 1b study of xaluritamig is ongoing with high-risk biochemically recurrent prostate cancer after definitive therapy. A Phase 1b study of xaluritamig in combination with androgen receptor pathway inhibitors is enrolling patients with metastatic hormone-sensitive prostate cancer. A Phase 1b study of xaluritamig was initiated in adult, adolescent and pediatric patients with relapsed or refractory Ewing sarcoma. Bemarituzumab Bemarituzumab is a first-in-class fibroblast growth factor receptor 2b (FGFR2b) targeting monoclonal antibody. Based upon data from the FORTITUDE-101 and FORTITUDE-102 Phase 3 studies, the Company does not intend to pursue regulatory approval in first-line gastric cancer. FORTITUDE-103, a Phase 1b/2 study of bemarituzumab plus oral chemotherapy regimens with or without nivolumab in patients with first-line gastric cancer was stopped. FORTITUDE-301, a Phase 1b/2 basket study of bemarituzumab monotherapy in patients with solid tumors with FGFR2b overexpression was completed. 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 ongoing patients with methylthioadenosine phosphorylase (MTAP)-null previously treated advanced non-small cell lung cancer (NSCLC). A Phase 1/1b/2 study of AMG 193 has completed enrollment of 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 ongoing in patients with NSCLC, ovarian cancer or breast cancer. Biosimilars A randomized, double-blind comparative clinical study of ABP 206 compared with OPDIVO® has completed enrollment in 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 has completed enrollment patients with advanced or metastatic non-squamous NSCLC. A randomized, double-blind, pharmacokinetic similarity/comparative clinical study of ABP 692 compared to OCREVUS® (ocrelizumab) is enrolling patients with relapsing-remitting multiple sclerosis. TEZSPIRE is being developed in collaboration with AstraZeneca. AMG 104 is being developed in collaboration with AstraZeneca. Xaluritamig, formerly AMG 509, is being developed pursuant to a research collaboration with Xencor, Inc. YL201 is an investigational B7-H3 targeting antibody-drug conjugate being developed by MediLink. 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 fourth quarters and full years 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 2026 EPS and tax guidance in accordance with GAAP and on a non-GAAP basis. These non-GAAP financial measures are computed by excluding certain items related to acquisitions, 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 fourth quarters and full years of 2025 and 2024. FCF is computed by subtracting capital expenditures from operating cash flow, each as determined in accordance with GAAP. Management has also presented Earnings Before Interest, Taxes, Depreciation and Amortization (EBITDA) and debt leverage ratio for 2025, both of which are non-GAAP financial measures. EBITDA is computed by adding interest expense, provision for income taxes, and depreciation and amortization expense to GAAP net income. Debt leverage ratio is calculated as the ratio of GAAP total debt to EBITDA. 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 believes its debt leverage ratio provides a supplemental operating metric for the full year period as it compares the amount of cash generated by our operations for the year. The Company uses the non-GAAP financial measures set forth in the news release in connection with its own budgeting and financial planning internally to evaluate the performance of the business, including to allocate resources and to evaluate results relative to incentive compensation targets. The non-GAAP financial measures are in addition to, not a substitute for, or superior to, measures of financial performance prepared in accordance with GAAP. About Amgen Amgen discovers, develops, manufactures and delivers innovative medicines to fight some of the world's toughest diseases. Harnessing the best of biology and technology, Amgen reaches millions of patients with its medicines. More than 45 years ago, Amgen helped establish the biotechnology industry at its U.S. headquarters in Thousand Oaks, California, and it remains at the cutting edge of innovation, using technology and human genetic data to push beyond what is known today. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases and obesity and obesity-related conditions. Amgen has been consistently recognized for innovation and workplace culture, including honors from Fast Company and Forbes. Amgen is one of the 30 companies that comprise the Dow Jones Industrial Average®, and it is also part of the Nasdaq-100 Index®, which includes the largest and most innovative non-financial companies listed on the Nasdaq Stock Market based on market capitalization. For more information, visit Amgen.com and follow Amgen on X, LinkedIn, Instagram, YouTube, Facebook, TikTok and Threads. Forward-Looking Statements This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including any statements on the outcome, benefits and synergies of collaborations, or potential collaborations, with any other company (including BeOne Medicines Ltd. or Kyowa Kirin Co., Ltd.), the performance of Otezla® (apremilast), our acquisitions of ChemoCentryx, Inc., Dark Blue Therapeutics, Ltd. or Horizon Therapeutics plc (including the prospective performance and outlook of Horizon's business, performance and opportunities, and any potential strategic benefits, synergies or opportunities expected as a result of such acquisition), as well as estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes, effects of pandemics or other widespread health problems on our business, outcomes, progress, and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission reports filed by Amgen, including our most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and current reports on Form 8-K. Unless otherwise noted, Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise. No forward-looking statement can be guaranteed and actual results may differ materially from those we project. Our results may be affected by our ability to successfully market both new and existing products domestically and internationally, clinical and regulatory developments involving current and future products, sales growth of recently launched products, competition from other products including biosimilars, difficulties or delays in manufacturing our products and global economic conditions, including those resulting from geopolitical relations and government actions. In addition, sales of our products are affected by pricing pressure, political and public scrutiny and reimbursement policies imposed by third-party payers, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment. Furthermore, our research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. We or others could identify safety, side effects or manufacturing problems with our products, including our devices, after they are on the market. Our business may be impacted by government investigations, litigation and product liability claims. In addition, our business may be impacted by the adoption of new tax legislation or exposure to additional tax liabilities. Further, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors, or we may fail to prevail in present and future intellectual property litigation. We perform a substantial amount of our commercial manufacturing activities at a few key facilities, including in Puerto Rico, and also depend on third parties for a portion of our manufacturing activities, and limits on supply may constrain sales of certain of our current products and product candidate development. An outbreak of disease or similar public health threat, and the public and governmental effort to mitigate against the spread of such disease, could have a significant adverse effect on the supply of materials for our manufacturing activities, the distribution of our products, the commercialization of our product candidates, and our clinical trial operations, and any such events may have a material adverse effect on our product development, product sales, business and results of operations. We rely on collaborations with third parties for the development of some of our product candidates and for the commercialization and sales of some of our commercial products. In addition, we compete with other companies with respect to many of our marketed products as well as for the discovery and development of new products. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, some raw materials, medical devices and component parts for our products are supplied by sole third-party suppliers. Certain of our distributors, customers and payers have substantial purchasing leverage in their dealings with us. The discovery of significant problems with a product similar to one of our products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on our business and results of operations. Our efforts to collaborate with or acquire other companies, products or technology, and to integrate the operations of companies or to support the products or technology we have acquired, may not be successful, and may result in unanticipated costs, delays or failures to realize the benefits of the transactions. A breakdown, cyberattack or information security breach of our information technology systems could compromise the confidentiality, integrity and availability of our systems and our data. Our stock price is volatile and may be affected by a number of events. Our business and operations may be negatively affected by the failure, or perceived failure, of achieving our sustainability objectives. The effects of global climate change and related natural disasters could negatively affect our business and operations. Global economic conditions may magnify certain risks that affect our business. Our business performance could affect or limit the ability of our Board of Directors to declare a dividend or our ability to pay a dividend or repurchase our common stock. We may not be able to access the capital and credit markets on terms that are favorable to us, or at all. CONTACT: Amgen, Thousand Oaks Elissa Snook, 609-251-1407 (media) 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. SOURCE Amgen 21% more press release views with Request a Demo