Milvexian

1 整体表现 JNJ在Ustekinumab专利悬崖的巨大冲击下，业绩持续保持坚挺，给予了市场巨大信心，市值已经创下新高最高达$580b。 医药板块看起来比器械还是更快走出低迷，收入同比增速持续回暖、本季度增长11.2%，利润也维持一定的成长，而器械还处于收入增速10%以下、利润波动的泥潭，这也解释了股价的大幅新高。 自从确定专利悬崖冲击基本上扛过去之后，公司的信心与日俱增，看到一季度持续走稳，2026年指引则继续加码，收入的中位预期增长6.1%、全年收入绝对值正式突破$100b大关，EPS的中位预期增长7.1%。 2 已上市产品 JNJ确实创造了医药史上难得一见的奇迹，在公司第一大品种在专利悬崖中遭受暴击的情况下，仍能稳住阵脚，业绩还在持续增长。凭借11个产品两位数增速和28个产品年销售过$1b的强势驱动，一季度医药板块收入同比增长7.4%，而事实上如果不考虑Ustekinumab单季带来将近$1b缺口和540bp增速逆风，同比增速将是恐怖的16.6%，从下图除Ustekinumab以外的产品梯队完整均衡也能看得出来。手握这样的增长引擎，CEO Duato也自豪地许下“公司史上最强产品管线”“正在迈向全年千亿目标”“2030年前维持两位数增速”一系列豪言壮语。 肿瘤板块自从发下了“2030年成为销售额$50b的第一大肿瘤药企”的宏愿之后，确实走出了六亲不认的步伐：Daratumumab上市已过十年，却仍维持着单调增长，特别是在四联治疗1L TE-NDMM获批后的份额迅速达到12%，整体爬坡再次加速，单季接近$4b、LTM累计已突破$15b，在如此大基数下还保持着接近20%增速；Cilta-cel在解决产能瓶颈之后，环比增速并没有如愿起飞，单季刚接近$600m、LTM累计$2.1b，距离曾经反复拍胸脯的$5b峰值还有不小距离；刚获批一年多的Amivantamab+Lazertinib组合，在1L NSCLC优效数据的巨大加持下，单季迅速突破$250m；此外，Teclistamab和Talquetamab两个双抗单季分别$202m和$152m，在与Daratumumab联用获批前线治疗后，爬坡速度有所提升。 自免板块彻底翻过了Ustekinumab这一页，进入Guselkumab+Icotrokinra的组合时代，公司不仅坚定了前者峰值超过$10b的信心，更是给后者吹出了“largest product ever”的牛。不过从现实来看，Guselkumab这个季度环比有所放缓，单季刚过$1.6b、LTM累计在$5.8b。 神经板块在同样领了“2030年成为神经领域第一大厂”的军令状后，近期的表现也有点阴晴不定：Paliperidone在经历去年Part D redesign冲击后，重新回到稳步成长的轨道，单季再次回到$1b以上；鼻喷抑郁症药物Esketamine在连续几个季度强劲表现之后终于回落，单季$468m；当然，肩负未来最大希望的还得是重金收购ITCI得到的Lumateperone，在收购后连续几个季度增长十分平缓，即使重头适应症MDD在去年底获批，似乎也并没有带来增速拐点，虽然公司声称起步新患者数达到有史以来最高，目前单季度仅$270m、LTM累计还不到$1b。 心血管板块自从被排除在公司医药板块的三大支柱（肿瘤+自免+神经）以外，就彻底陷入了低潮期：Rivaroxaban在衰退通道中还在回光返照，后面就坐等公司心目中又一个$5b峰值预期的爆款Milvexian，这成了心血管板块唯一能拿出手的故事；Macitentan和Selexipag两个PAH产品则在美国医保谈判（Part D redesign）的压制下停步不前，始终徘徊在单季$1b出头，然而Macitentan在2026年就面临LoE，似乎想要配得上当初$30b收购Actelion的价码只存在理论上的可能性，甚至公司近期的季报和电话会里都开始不配拥有画面了。 3 在研管线 这个季度最最头等的大事，毋庸置疑是自免板块乃至全公司的未来之星（毕竟都钦定了largest product ever）口服多肽Icotrokinra获得FDA批准，此外还在AAD上公布了治疗银屑病ADVANCE1&2试验的52周维持期结果。至业绩发布的一个月左右就已经有1,500名新患，公司对此次launch的信心和自豪都溢于言表。Icotrokinra当然是口服多肽modality的巨大里程碑式胜利，但是否能兑现JNJ给市场立起的这么大flag，笔者个人还持相当大的观望态度。（参见【药海听涛】小无相功与少林绝技：从JNJ-2113看银屑病竞争格局和【药海听涛】软柿子还是硬茬子：口服多肽JNJ-2113的阶段性胜利）。 自免板块除了Icotrokinra，另一个潜力新秀Nipocalimab也有进展，在最受关注的治疗SLE的二期临床JASMINE试验中，Nipocalimab达到主要临床终点24周SRI-4响应，成为首个对SLE有积极结果的FcRn抑制剂，开启三期临床的同时也获得FDA在这个适应症的FTD，看看能否借此跟argenx掰掰手腕。 肿瘤板块比较重要的进展是Teclistamab联合Daratumumab皮下剂型获批治疗二线r/r MM，总算从末线往前挪了一步，本次批准基于MajesTEC-3试验的惊艳结果，OS的HR达到0.46。此外，还公布了Teclistamab单药在MajesTEC-9试验中治疗CD38+Lenalidomide双重难治患者的积极结果。 另一个相对早期的肿瘤管线进展，是JNJ的心头好KLK2靶点，TCE分子Pasritamig在ASCO GU上亮相。在联用多西他赛治疗末线mCRPC的Ph1b临床试验中，PSA50和PSA90分别为64.7%和39.2%，其中紫杉醇未经治的患者则分别为75.0%和53.6%，而且要考虑到患者基线相当重（1-9线）、还有20%接受过Pluvicto；最大的惊喜其实在安全性，没有任何级别的CRS，≥G3 TRAE仅27.5%，这远好于此前其他TCE，诸如Janux的JANX-007和Amgen的AMG-509，意味着后续有更大的探索空间。 在季报之后，公司没头没尾地单独发了条公告，终止了曾以2.45亿美元首付款从西比曼引进的两款CAR-T资产，最戏谑之处在于仅半年以前，JNJ管理层还在MS的会上兴致勃勃地将这俩标榜为Best-in-class（这里绝对要鸣谢AI，靠我自己不可能找到这么犄角旮旯的script证据）。 除此以外，值得关注的进展还包括：Guselkumab+Golimumab组合疗法JNJ-4804从Royalty Pharma拿了$500m进行co-funding合作项目，OX2R拮抗剂Seltorexant更新治疗MDD的三期临床数据，膀胱内给药系统的又一个管线TAR-210（Erdafitinib）公布NMIBC一期临床积极数据，等等。 强生JNJ往期季报分析： 【医苑观畴】主流技术方向谁说了算：2022年上半年全球大药企核心产品管线进展总览 【医苑观畴】主流技术方向谁说了算：2022年下半年全球大药企核心产品管线进展总览 【医苑观畴】2023年上半年全球大药企核心进展总览 【医苑观畴】2024年一季度海外药企进展更新：强生JNJ 【医苑观畴】2024年二季度海外药企进展更新：强生JNJ 【医苑观畴】2024年三季度海外药企进展更新：强生JNJ 【医苑观畴】2024年全年及四季度海外药企进展更新：强生JNJ 【医苑观畴】2025年一季度海外药企进展更新：强生JNJ 【医苑观畴】2025年二季度海外药企进展更新：强生JNJ 【医苑观畴】2025年三季度海外药企进展更新：强生JNJ

Bristol-Myers Squibb held its BMY Q1 2026 earnings conference call on April 30, 2026, with management highlighting a late-stage pipeline approaching a cluster of pivotal readouts across cardiovascular disease, fibrotic lung disease, neuroscience, and hematology. The key near-term catalysts include milvexian in AFib and secondary stroke prevention, admilparant in IPF, Cobenfy in Alzheimer’s disease psychosis, and the company’s CELMoD protein degradation platform in relapsed or refractory multiple myeloma. Management framed these readouts as central to defining BMS’s growth profile into the next decade. Key Strategic Signals CELMoD Platform: The iberdomide new drug application was accepted by the US FDA with Breakthrough Therapy Designation and Priority Review, carrying a PDUFA date of August 17, 2026. Separately, mezigdomide hit a positive interim progression-free survival endpoint in the SUCCESSOR-2 Phase III trial ahead of schedule, with full data to be presented at ASCO. Chief Medical Officer Cristian Massacesi said the company intends to position both iberdomide and mezigdomide as replacements for Revlimid (lenalidomide) and Pomalyst (pomalidomide) in second-line relapsed or refractory multiple myeloma (RRMM), with longer-term ambitions to pair them with T-cell redirecting therapies and cell therapy. Admilparant: The company’s LPA1 inhibitor admilparant is advancing through Phase III trials in idiopathic pulmonary fibrosis (IPF), with a readout guided for the second half of 2026, and progressive pulmonary fibrosis (PPF), with data expected in early 2027. Massacesi cited Phase II results showing greater than 60% improvement versus placebo in lung function decline at the 60 milligram twice-daily dose, a clear dose-response relationship across tested doses, and ongoing Data Monitoring Committee reviews recommending continuation without safety flags. The company is running both Phase III studies with two doses — 60 milligram and 120 milligram — providing two shots at demonstrating efficacy. Management described admilparant as first-in-class for both indications with a tolerability profile meaningfully differentiated from current antifibrotics, where approximately 50% to 60% of patients discontinue therapy within 12 months. Non-Obstructive HCM: Massacesi announced that BMS is planning a new, more focused Phase III study in non-obstructive hypertrophic cardiomyopathy (HCM) for Camzyos (mavacamten), informed by learnings from the ODYSSEY trial. He said the company now has a clearer understanding of which patient subpopulations and disease subtypes are most likely to benefit from myosin inhibition, and that trial details would be registered on ClinicalTrials.gov. This represents a strategic attempt to recover a previously failed indication through refined patient selection. Analyst Pressure Points Milvexian Trial Design and Subgroup Risk: Analysts from Wolfe Research and UBS pressed management on whether the milvexian AFib trial — the Librexia program — could produce a partial or ambiguous result, and whether historically lower stroke event rates in contemporary AFib trials could delay the readout into 2027. Massacesi acknowledged the study is event-driven and that the company remains blinded, but said the predefined event count for both efficacy and safety is accruing as planned and that a year-end readout remains the base case. He declined to specify a bleeding reduction threshold required for commercial success, and analysts noted the non-inferiority margins of 0.84 to 1.3 on efficacy leave meaningful room for interpretation if the efficacy result lands close to the boundary. Cobenfy ADEPT Program Heterogeneity: Analysts at Jefferies questioned why BMS added mandatory biomarker confirmation of Alzheimer’s diagnosis to the ADEPT-4 trial design — requiring plasma or imaging confirmation — when ADEPT-2 was already enrolling without that requirement. Massacesi said the decision was made to reduce patient population heterogeneity and increase confidence that enrolled patients have confirmed Alzheimer’s disease, while acknowledging that the biomarker screening requirement increases operational complexity and screening failures. He framed ADEPT-2 and ADEPT-4 as parallel shots on goal, with the company requiring at least two positive studies for a regulatory filing. BMS has since added ADEPT-5 to the program, giving it four trials in Alzheimer’s disease psychosis (ADP). Forward-Looking Catalysts H2 2026 — Milvexian Phase III Readouts (AFib and SSP): Both the Librexia AFib trial, enrolling 20,500 patients in a head-to-head comparison against apixaban, and the secondary stroke prevention (SSP) trial are on track for year-end readouts. The AFib study is powered to demonstrate non-inferiority on stroke prevention and superiority on bleeding, with the bleeding endpoint split between measured bleeds and clinically relevant non-major bleeds. Chief Commercialization Officer Adam Lenkowsky said payers are not anchored to a specific percentage bleeding reduction threshold but are seeking a clinically meaningful and statistically credible reduction in major bleeds that translates into fewer hospitalizations. BMS would be the only company with a Factor XIa inhibitor approved in both AFib and SSP if successful. H2 2026 — Admilparant IPF Phase III Readout: The IPF data readout is the catalyst Massacesi described as among the most critical of the year. Both Phase III studies stratify patients by prior antifibrotic use — pirfenidone or nintedanib — allowing for analysis as an add-on or monotherapy, and the DMC has continued both studies without modification. Management said the Phase III population was designed to closely mirror the Phase II population to maximize translation of the earlier efficacy signal. Pipeline Context: Pumitamig and the CELMoD Depth During the Bristol-Myers Squibb Q1 earnings transcript, analysts also asked about pumitamig, BMS’s PD-1 x VEGF bispecific antibody developed in partnership with BioNTech. Massacesi said the company is presenting Phase II non-small cell lung cancer (NSCLC) data as an oral presentation at ASCO — the first global dataset following earlier China-specific data — and that seven pivotal Phase III studies across indications are all actively recruiting. He framed pumitamig’s strategy as “replace and expand,” targeting replacement of PD-1 and PD-L1 inhibitors while extending into novel combinations. BMS has initiated combination studies pairing pumitamig with Iza-bren (izalontamab brengitecan), its EGFR-HER3 antibody-drug conjugate (ADC), and with navlimetostat, a PRMT5 inhibitor, reflecting a deliberate effort to build pumitamig as a combinability backbone across tumor types. On the CELMoD platform, CEO Christopher Boerner highlighted golcadomide as an underappreciated asset, citing high-quality data accruing ahead of ASCO presentations. He also noted that earlier-stage degraders — BCL6-LDD and AR-LDD — are advancing behind the lead programs, indicating a platform depth that extends well beyond the two assets closest to approval. During the Bristol-Myers Squibb earnings call, Massacesi also confirmed that Arlo-cel, a GPRC5D-targeted CAR-T in RRMM, is expected to produce a pivotal readout later in 2026. In autoimmune disease cell therapy, BMS outlined a three-modality immune reset strategy: zola-cel, an autologous CD19 CAR-T in pivotal studies for lupus and scleroderma; an allogeneic CAR-T now in the clinic; and an mRNA-based in vivo CAR-T platform acquired through Orbital, which could improve scalability by enabling patients to generate CAR-T cells in vivo. Across the BMY Q1 2026 earnings discussion, Christopher Boerner framed the company’s R\&D productivity agenda around two quantified targets: a 50% reduction in lead molecule identification time and a 30% reduction in late-stage development cycle times versus a few years ago, supported by AI partnerships with Faro and Evinova. He said business development remains a capital allocation priority and that BMS is size-agnostic in evaluating opportunities, with a preference for assets in therapeutic areas where the company can add clinical and commercial value. 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