Dazodalibep

2月3日，安进（Amgen）公布2025年第四季度及全年业绩，营收和盈利均超预期，降胆固醇药物依洛尤单抗成为主要增长引擎。 公司管理层在财报电话会上反复强调其每月一次用药的减重与代谢疾病管线的差异性优势潜力，定位2026年为“未来增长的跳板年”。 因疗效未达预期，公司终止了FGFR2b 的单抗 bemarituzumab的开发。 2 月 3 日，生物制药巨头安进（Amgen）发布 2025 年第四季度及全年财报，一系列亮眼数据勾勒出这家企业在全球医药市场的稳健身姿。营收与非 GAAP 每股收益（EPS）双双实现 10% 的同比增长，18 款产品创下年度销售纪录，14 款产品年销售额突破 10 亿美元，13 款产品达成双位数增长 —— 这组沉甸甸的数字背后，是安进在研发投入、管线布局与商业化运营上的多维深耕。 财务表现：稳健增长与结构优化并行 2025 年，安进全年总营收达 367.51 亿美元，同比增长 10%；产品销售额同比攀升 10% 至 351.48 亿美元，占总营收的九成以上，核心业务的增长韧性尽显。第四季度表现同样可圈可点，总营收 98.66 亿美元，同比增长 9%，产品销售贡献 93.67 亿美元，同比增长 7%，其他营收则以 35% 的同比增幅成为意外亮点。 盈利端，公司展现出强大的成本控制能力。尽管全年研发投入同比激增 22% 至 71.83 亿美元，占产品销售额的 20.4%，但非 GAAP 运营利润率仍稳定在 46.1%。值得一提的是，销售、一般及管理费用（SG&A）同比仅增长 2%，占产品销售额的比例从 21.2% 降至 19.8%，效率提升成效显著。第四季度非 GAAP 每股收益 5.29 美元，虽较上年同期微降 0.4%，但全年非 GAAP 每股收益达 21.84 美元，同比增长 10%，与营收增速完美匹配。 现金流与资产结构上，安进全年自由现金流 81 亿美元，虽较上年有所回落，但仍足以支撑其研发投入与股东回报 —— 全年股息每股增长 6% 至 2.38 美元，展现出对投资者的持续回馈。截至 2025 年末，公司现金及现金等价物为 91.29 亿美元，债务总额降至 546.04 亿美元，债务杠杆率 3.2 倍，财务状况趋于稳健。 研发管线：四大治疗领域构筑增长护城河 安进 2025 年在研发上的 70 亿美元投入，正转化为管线中源源不断的创新动力。公司围绕一般医学、罕见病、炎症、肿瘤四大治疗领域，构建了兼具广度与深度的 Phase 3 管线矩阵，5 项 FDA 批准、Repatha® 的里程碑式临床数据、6 项 MariTide 全球 Phase 3 研究的启动，共同勾勒出未来增长的清晰路径。 一般医学领域，MariTide（maridebart cafraglutide, AMG 133）无疑是最耀眼的明星。这款针对肥胖、2 型糖尿病（T2D）及相关并发症的候选药物，已启动 6 项全球 Phase 3 研究，覆盖慢性体重管理、心血管结局、心力衰竭、阻塞性睡眠呼吸暂停等多个适应症。Phase 2 研究数据显示，多数患者在低剂量维持治疗下仍能保持 15% 以上的体重降幅，且安全性良好，胃肠道不良反应发生率极低；针对 T2D 的 Phase 2 研究更实现了血红蛋白 A1c（HbA1c）与体重的双重显著下降，公司计划 2026 年启动其 T2D 适应症的 Phase 3 研究。 MariTide 的多适应症布局，使其有望成为横跨代谢与心血管领域的超级重磅产品。 Repatha® 的 Phase 3 VESALIUS-CV 临床试验则为心血管领域再添重磅证据。在超过 1.2 万名无既往心梗或中风史的动脉粥样硬化或糖尿病患者中，Repatha® 使 3-P MACE（冠心病死亡、心梗或缺血性中风复合终点）风险相对降低 25%，心梗风险更是大幅下降 36%，研究结果同步发表于《新英格兰医学杂志》，为其市场拓展注入强劲动力。此外，针对Lp (a) 相关心血管风险的 Olpasiran，其两项 Phase 3 预防研究正在推进，有望填补该领域的治疗空白。 罕见病领域，安进持续收获监管突破与销售增长。UPLIZNA® 年内斩获欧盟与 FDA 的两项新适应症批准，年销售额同比暴涨 73% 至 6.55 亿美元；TAVNEOS® 销售额同比增长 62% 至 4.59 亿美元，针对 6 至 18 岁 ANCA 相关性血管炎患者的 Phase 3 研究正在招募。TEPEZZA® 在甲状腺眼病（TED）领域的皮下给药 Phase 3 研究预计 2026 年下半年完成，有望进一步提升用药便利性与患者依从性。而 dazodalibep 针对干燥综合征的两项 Phase 3 研究、daxdilimab 在盘状红斑狼疮中的阳性 Phase 2 数据，也彰显了公司在罕见自身免疫性疾病领域的深度布局。 炎症领域，TEZSPIRE® 表现抢眼，年销售额同比增长 52% 至 14.78 亿美元，针对慢性阻塞性肺疾病（COPD）与嗜酸性食管炎的 Phase 3 研究正在推进。不过，公司也对管线进行了策略性调整，终止了与 Kyowa Kirin 合作的 rocatinlimab 开发与商业化，将资源聚焦于更具潜力的项目。 肿瘤领域，创新疗法与适应症拓展双线并进。IMDELLTRA®（tarlatamab）获得 FDA 完全批准用于铂类化疗进展后的广泛期小细胞肺癌（ES-SCLC），全年销售额达 6.27 亿美元，全球多区域监管审查正在推进，公司更在布局 ES-SCLC 与局限期 SCLC 的全面临床开发。BLINCYTO® 年销售额同比增长 28% 至 15.59 亿美元，针对老年新诊断 CD19 阳性 Ph 阴性 B 细胞急性淋巴细胞白血病（B-ALL）的 Phase 3 研究正在招募。Xaluritamab 围绕转移性去势抵抗性前列腺癌（mCRPC）开展了多项 Phase 3 与 Phase 1b 研究，覆盖不同治疗阶段与联合用药方案，展现出成为前列腺癌领域核心疗法的潜力。 商业化表现：明星产品引领，多领域协同增长 2025 年，安进四大治疗领域均实现稳健增长，明星产品的引领作用与新兴产品的爆发式增长形成良性互补。 一般医学领域贡献超 110 亿美元收入，Repatha® 以 30.16 亿美元的年销售额同比增长 36%，成为该领域的核心增长引擎；EVENITY® 同比增长 34% 至 21 亿美元，两款产品均受益于 volume 增长与适应症拓展。唯一略显遗憾的是 Prolia®，全年销售额微增 1% 至 44.14 亿美元，公司预计 2026 年其将面临 biosimilar 竞争带来的销售压力。 罕见病领域创收超 50 亿美元，UPLIZNA® 与 TAVNEOS® 的爆发式增长成为最大亮点，KRYSTEXXA® 也以 13% 的同比增幅实现 13.4 亿美元销售额，受益于 volume 增长与净售价提升。Ultra-Rare 产品虽同比下滑 5%，但整体仍贡献 7.19 亿美元收入，构成罕见病业务的稳定基石。 炎症领域合计收入超 70 亿美元，TEZSPIRE® 与 PAVBLU® 的强劲表现对冲了 Enbrel® 与 AMJEVITA®/AMGEVITA 的下滑。Enbrel® 年销售额同比下降 33% 至 22.26 亿美元，AMJEVITA®/AMGEVITA 同比下滑 22%， biosimilar 竞争带来的冲击已显现。 肿瘤领域全年收入约 100 亿美元，BLINCYTO®、Vectibix®、IMDELLTRA® 等产品的增长势头良好，XGEVA® 则因 volume 下滑同比下降 6%，同样面临 2026 年 biosimilar 竞争加剧的挑战。 从区域表现看，美国市场仍是核心支柱，贡献 256.56 亿美元产品销售额，占比超七成；海外市场（ROW）销售额 94.92 亿美元，虽占比较小，但部分产品在海外市场的增长潜力值得期待，如 Repatha® 海外销售额达 13.53 亿美元，同比增长显著。 2026 展望：机遇与挑战并存 安进为 2026 年设定了稳健的增长目标：预计营收区间为 370 亿至 384 亿美元，非 GAAP 每股收益 21.60 至 23.00 美元，非 GAAP 税率 16.0% 至 17.5%，资本支出约 26 亿美元。这一目标既反映了公司对核心产品持续增长的信心，也暗含对 biosimilar 竞争、研发进展不确定性等风险的考量。 未来一年，安进的增长将主要依赖三大驱动力：一是 MariTide、Olpasiran 等重磅候选药物的临床推进与潜在获批；二是 Repatha®、TEZSPIRE®、IMDELLTRA® 等现有明星产品的适应症拓展与市场渗透；三是罕见病领域新兴产品的持续爆发。但挑战同样不容忽视，Prolia® 与 XGEVA® 面临的 biosimilar 竞争、研发投入持续高企带来的成本压力、全球医疗保健成本控制趋势下的定价压力，都将考验公司的运营与应变能力。 从行业视角看，安进的 2025 年业绩与管线布局，印证了生物制药企业 “创新为王、管线为纲” 的生存法则。在全球医药市场竞争日趋激烈的背景下，公司既保持了对核心治疗领域的深耕，又通过策略性并购与合作扩充管线边界，这种 “深度 + 广度” 的布局思路，或许正是其穿越行业周期、实现长期增长的关键。 2026 年，MariTide 的 Phase 3 研究数据、IMDELLTRA® 的全球市场拓展、罕见病与肿瘤领域新适应症的获批进展，将成为衡量安进增长潜力的核心看点。这家生物制药巨头能否在创新与商业化的平衡中持续领跑，值得行业持续关注。 安进电话会议全文 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。

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