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更新于：2025-02-10
Repotrectinib
瑞普替尼
更新于：2025-02-10
概要
基本信息
药物类型 小分子化药 |
别名 Repotrectinib (USAN)、Ropotrectinib、洛普替尼 + [11] |
作用机制 ROS1抑制剂(原癌基因酪氨酸蛋白激酶ROS抑制剂)、TrkA 拮抗剂(神经生长因子受体Trk-A 拮抗剂)、TrkB抑制剂(神经营养性酪氨酸激酶受体-2型抑制剂) |
在研适应症 |
非在研机构- |
最高研发阶段批准上市 |
首次获批日期 美国 (2023-11-15), |
最高研发阶段(中国)批准上市 |
特殊审评优先审评 (美国)、突破性疗法 (美国)、快速通道 (美国)、加速批准 (美国)、孤儿药 (美国)、优先审评 (中国)、突破性疗法 (中国)、附条件批准 (中国) |
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结构/序列
分子式C18H18FN5O2 |
InChIKeyFIKPXCOQUIZNHB-UHFFFAOYSA-N |
CAS号1802220-02-5 |
关联
18
项与 瑞普替尼 相关的临床试验NCT06315010
A Phase II Study Assessing Safety and Efficacy of REPotrectinib in ROS1-positive Non-small Cell Lung Cancer Patients With Active Brain mEtastasis (REPOSE Study)
REPOSE is a phase II clinical trial exploring the safety and efficacy of repotrectinib in patients with non-small cell lung cancer (NSCLC) characterized by the presence of brain metastasis (BM) and whose tumors have mutated ROS proto-oncogene 1, receptor tyrosine kinase (ROS1) gene.
开始日期2025-02-01 |
申办/合作机构 |
NCT05828303
A Phase 1, Open-Label, Fixed-Sequence Study to Evaluate the Potential Drug Interactions Between Repotrectinib and Metformin, Digoxin, and Rosuvastatin in Patients With Advanced Solid Tumors Harboring ROS1 or NTRK1-3 Rearrangements
This is a Phase 1 study to evaluate the potential drug-drug interaction (DDI) effect of repotrectinib on certain drug transporters in patients with advanced cancer.
开始日期2024-11-15 |
CTRI/2024/10/075224
Randomized, Open-label, Multicenter,Phase 3 Trial of Repotrectinib VersusCrizotinib in Participants with Locally Advanced or Metastatic Tyrosine Kinase Inhibitor (TKI)-naïve ROS1-positive Non-Small Cell Lung Cancer (NSCLC) (TRIDENT-3) - NIL
开始日期2024-11-01 |
100 项与 瑞普替尼 相关的临床结果
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100 项与 瑞普替尼 相关的转化医学
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100 项与 瑞普替尼 相关的专利（医药）
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93
项与 瑞普替尼 相关的文献（医药）2025-03-01·BIOORGANIC CHEMISTRY
A perspective on the application of macrocyclic design strategies in antitumor drugs
Review
作者: Zou, Zhong-Kai ; Li, Yan-Hong ; Lin, Yu-Kang ; Cai, Jian-Fan ; Zhao, Pei-Liang
The macrocyclization of inhibitors has become gradually favored as a new approach for drug design in the field of anticancer agents, since the recent approvals of lorlatinib, pacritinib, and repotrectinib, and feasibility of macrocyclic modification to improve inhibitor drug-like properties has also been confirmed. Macrocycles are receiving increasing attention due to their enhanced binding affinity, target selectivity, and pharmacokinetic properties through conformational constraints. Therefore, this review summarizes various strategies for improving drug-like properties in macrocyclization and structural optimization, and reveals that macrocyclization is a new favorable strategy for drug design, aiming to provide insights for the drug discovery in different targets.
2025-01-01·Med
If it is a solid tumor target, then it may be a hematologic cancer target: Bridging the great divide
Review
作者: Adashek, Jacob J ; Munoz, Javier L ; Kurzrock, Razelle
Tumor-agnostic US Food and Drug Administration approvals are transforming oncology. They include larotrectinib/entrectinib/repotrectinib (NTRK fusions), selpercatinib (RET fusions), dabrafenib/trametinib (BRAFV600E mutations), pembrolizumab/dostarlimab (microsatellite instability), pembrolizumab (high tumor mutational burden), and trastuzumab deruxtecan (HER2 3+ expression) (all solid cancers). Pemigatinib is approved for FGFR1-rearranged myeloid/lymphoid neoplasms. The genomically driven tissue-agnostic approach has a strong biological rationale (cancer is a disease of the genome), yields remarkably high response rates, and provides drug access to patients with an unmet need (rare/ultra-rare malignancies). Despite the solid tumor focus, both solid and hematologic cancers can harbor identical driver molecular abnormalities and respond to cognate therapies. For example, BRAFV600E and IDH1/2 mutations; ALK, FGFR, and NTRK fusions; PD-L1 amplification; and CD70 antigens are druggable in both solid and blood malignancies by gene-/immune-targeted therapies/chimeric antigen receptor T cells. Future biomarker-based tissue-agnostic basket studies/approvals should bridge the great divide and include both solid and hematologic cancers.
2024-12-20·JOURNAL OF BIOMOLECULAR STRUCTURE & DYNAMICS
The promising impact of Bemcentinib and Repotrectinib on sleep impairment in Alzheimer’s disease
Article
作者: Ramezani, Fatemeh ; Ariaei, Armin
Alzheimer's disease (AD), the most prevalent neurodegenerative disease, demands effective medication to alleviate symptoms. This study focused on sleep impairment as an overt clinical symptom and tauopathy as a prominent molecular symptom of this disease. Multiple compounds from three biomolecule libraries (719 compounds; ChemDiv:366 - ChEMBL:180 - PubChem:173) were evaluated for potential binding affinity and safety using AutoDock Vina and pkCSM, respectively, resulting in the selection of four candidate compounds (Lestaurtinib, Repotrectinib, Bemcentinib, and Zotiraciclib). Due to the similarity of Repotrectinib and Bemcentinib binding sites to ATP, 300 ns Martini 3 coarse-grained molecular dynamics (MD) was performed on these two molecules and ATP by NAMD. The stability of tau protein in the presence of drugs was assessed using a 200 ns Martini 3 MD simulation. Binding site analysis discloses Bemcentinib and Repotrectinib as two inhibitors occupying most amino acids in binding with ATP. The RMSD and RMS average correlation results revealed protein containing Bemcentinib and Repotrectinib to have a more stable state compared to ATP in the first 220 ns simulation. There was only a single detachment of Bemcentinib, while Repotrictinib detached twice at the end of the simulation. Eventually, adding Bemcentinib and Repotrectinib to the enzyme-tau complex significantly increased the number of tau detachments during the 200 ns simulation. We report Bemcentinib and Repotrectinib, formerly prescribed for cancer, as potential inhibitors of the CK1 δ. Besides their high binding affinity compared to ATP, they can inhibit all ATP-binding sites and alter the tau binding stability.Communicated by Ramaswamy H. Sarma.
388
项与 瑞普替尼 相关的新闻（医药）2025-02-09
·今日头条
近年来，靶向和免疫药物势如破竹的研发和上市，让肺癌的治疗步入了黄金时代，在刚刚过去的2024年，22款肺癌明星药物纷纷获批，其中中国上市16款肺癌新药，美国上市7款，这意味着一些幸运的病友等来了新的选择和希望！
好消息是，目前国外上市的以及中国自主研发的几款针对肺癌EGFR,ALK,ROS1,RET,MET,NTRK靶点的抗肿瘤新药，开始招募国内患者了！这意味着，国内的患者也终于有机会免费用上这些效果更好，堪称天价的抗癌新疗法！全球肿瘤医生网将2025年肺癌病友们可以申请的17款新药临床试验信息整理如下，想申请的患者可以提交病历至全球肿瘤医生网将医学部进行初步评估！
2025非小细胞肺癌17款“续命”新药
01
EGFR
EGFR(epidermal growth factor receptor，ErbB-1或HER1)表皮生长因子受体主要在肺腺癌、亚裔、非吸烟及女性患者中，大约有 15% 的白种人和 30-50% 的亚洲人中有 EGFR 基因突变。无吸烟史者，比例高达 50-60%，常见的突变位点是外显子19和21，占90%，称为经典型突变，其余10%为外显子18和20的突变。目前多款国内和国际的明星新药正在招募。
01
Ifebemtinib（IN10018）
药品名称：
甲磺酸哆希替尼片
作用靶点：
EGFR
研发公司：
应世生物
药物介绍：
是一种高效、高选择性的FAK抑制剂。IN10018早期临床数据显示了其良好的安全性和多癌种有效性。最新研究成果表明IN10018有望通过克服肿瘤基质纤维化屏障和调节肿瘤免疫抑制性微环境，实现突破肿瘤防御机制，有效克服耐药和转移，成为多种治疗方案的基石分子。
适应症：
EGFR突变肺癌
入组条件（部分）：
1.有EGFR-TKI敏感性相关的EGFR突变，包括Ex19del或L858R。除外EGFR-TKI敏感突变，可合并其他EGFR突变类型如T790M等。
2.既往经三代EGFR-TKI治疗进展，并接受过1-2线化疗（需至少包括 1线含铂化疗），且化疗进展或不耐受的NSCLC受试者.
02
SKB264
药品名称：
SKB264
作用靶点：
EGFR
研发公司：
科伦博泰生物
药物介绍：
注射用SKB264是靶向人滋养层细胞表面抗原2（TROP-2，在多种上皮来源肿瘤中高表达）的抗体偶联药物（ADC）药物，其偶联方式和毒素小分子具有自主知识产权，拟用于恶性实体瘤的治疗。早期临床研究结果显示了SKB264在转移性实体瘤患者中良好的耐受性、安全性和令人鼓舞的抗肿瘤活性。
适应症：
EGFR突变肺癌
入组条件（部分）：
1.经肿瘤组织学或细胞学或血液学证实存在EGFR敏感突变；2.既往接受过EGFR-TKI治疗且治疗失败；3.既往接受过针对局部晚期或转移性NSCLC的至少一种含铂化疗失败。
03
JMT-101
药品名称：
JMT-101
作用靶点：
EGFR20 ins
研发公司：
津曼特
药物介绍：
JMT101为人源化抗EGFR单克隆抗体，具有自主知识产权，该产品相较于国内外已上市同类产品西妥昔单抗、帕尼单抗等具有亲和力更高、免疫原性低、药效更优的特点。该产品已于2016年5月获得CFDA临床批件，现已进入I期临床研究，拟用于治疗非小细胞肺癌，结直肠癌等实体瘤。疾病控制率100%，我国自主研发广谱新药重磅登场！临床招募进行中
适应症：
一线或二线治疗EGFR突变20ins阳性肺癌
招募信息（部分）：
ⅢB或Ⅳ期非小细胞肺癌，不适合进行根治性手术或放疗，且证实具有EGFR 20号外显子插入突变（包括重复突变），初治或一线治疗失败后的患者。
04
伏美替尼
药品名称：
伏美替尼 (AST2818，艾弗沙)
作用靶点：
EGFR 20ins
研发公司：
艾力斯
药物介绍：
第三代EGFR抑制剂。2021年3月在国内获批上市，治疗EGFR T790M突变型非小细胞肺癌。国研第三代EGFR抑制剂，上市！新适应症临床试验开启！
适应症：
EGFR突变20ins阳性肺癌
招募信息（部分）：
ⅢB或Ⅳ期非小细胞肺癌，不适合进行根治性手术或放疗，且证实具有EGFR 20号外显子插入突变（包括重复突变）。
05
PLB1004
药品名称：
安达替尼（PLB1004）
作用靶点：
EGFR 20ins
研发公司：
鞍石生物
适应症：
EGFR突变20ins阳性肺癌
药物介绍：
中国原研、具有全球知识产权的新型单苯胺基嘧啶小分子EGFR抑制剂，可有效且不可逆地靶向外显子20插入突变，同时还有效针对经典 EGFR 突变 ExDel19、L858R 和 T790M，与野生型 EGFR 相比具有高度选择性。这款药物是在保持第三代EGFR TKI药效优势的前提下，针对EGFR Ex20插入设计的全新一代EGFR TKI。
招募信息（部分）：
ⅢB或Ⅳ期非小细胞肺癌，且证实具有EGFR 20号外显子插入突变（包括重复突变）。
02
ALK
对于确定为ALK阳性的患者是幸运的，因为针对ALK的靶向药有效率超高，副作用不大，一不注意肿瘤就给“吃没了”。因此，ALK突变被称为“钻石突变”，虽然仅有5%，但可用的靶向药却很多，显着增加了治疗机会，ALK最常见的融合伴侣是ALK-EML4（棘皮类微管相关样蛋白4）。它更容易出现在既往少量 / 无吸烟史和年轻的患者身上。
01
TL139
作用靶点：
ALK/ROS1/NTRK融合
研发公司：
苏州韬略
药物介绍：
TL139是一款新一代NTRK/ROS1/ALK多靶点抑制剂。
适应症：
二线治疗ALK/ROS1/NTRK阳性实体瘤
招募信息（部分）：
ALK阳性，既往接受过≤2种ALK抑制剂的治疗（用过化疗没用过ALK抑制剂的也可以）
ROS1阳性，既往接受过≤1种ROS1抑制剂的治疗
NTRK阳性，接受一代NTRK抑制剂后进展（拉罗，恩曲，TL118）
03
ROS1
ROS1 全称 c-ros 原癌基因，是一种跨膜的受体酪氨酸激酶基因。出现ROS1突变的患者，更多的是年轻的、非吸烟的肺癌患者，其中肺腺癌居多。突变者约占 NSCLC 总数的 3%。
01
瑞普替尼
药品名称：
TPX-0005（Repotrectinib，瑞普替尼）
作用靶点：
ALK/ROS1/NTRK突变
研发公司：
TurningPoint/再鼎医药
药物介绍：
第二代ALK/ROS1/NTRK抑制剂。这款全新一代的ROS1，pan-TRK和ALK抑制剂，是一种经过特殊设计的低分子量大环TKI，具有高度选择性，对ROS1，TRKA-C和ALK具有很高的效力。临床证实其抗ROS1能力可以达到克唑替尼和恩曲替尼（Entrectinib，Etreso）的90倍以上！在ROS1融合的患者中，接受克唑替尼治疗后三分之一的患者出现现
ROS1 G2032R
，还有5%的患者会出现
ROS1 D2033N
。TPX-0005
能够克服临床中出现的所有已知ALK,ROS1和NTRK耐药问题。
适应症：
ROS1突变阳性肺癌
招募信息（部分）：
1、年龄：18~75，男性或女性;
2、ECOG评分0~1分，预期寿命≥3个月;
3、未经治疗的ROS1阳性肺癌
02
他雷替尼
药品名称：
Taletrectinib（DS-6051b / AB-106）
作用靶点：
ROS1/NTRK突变
研发公司：
TurningPoint/再鼎医药
药物介绍：
第二代ROS1/NTRK抑制剂。Talectrectinib代号为DS-6051b/AB-106，是一款新型、有效、选择性高的下一代ROS1和NTRK双靶点小分子抑制剂，可穿越血脑屏障。
适应症：
二线治疗ROS1突变阳性肺癌
招募信息（部分）：
1、年龄：18~75，男性或女性;
2、ECOG评分0~1分，预期寿命≥3个月;
3、标准治疗失败的ROS1+非小细胞肺癌患者
03
ICP-723
药品名称：
ICP-723
作用靶点：
ROS1突变
研发公司：
诺诚建华
药物介绍：
ICP-723是一种国内研发的第二代泛酪氨酸受体激酶（泛TRK）小分子抑制剂，用于治疗不同肿瘤类型的神经营养性酪氨酸激酶（NTRK）阳性的肿瘤患者以及由于抗性TRK基因突变而对第一代酪氨酸激酶（TRK）抑制剂产生耐药性的患者。2021年8 月 31 日，获得美国食品药品监督管理局（FDA）的研究性新药批准在美国开始 I 期临床试验。
适应症：
1.ROS1阳性非小细胞肺癌；
2.克唑替尼或化疗后进展。
04
TL139
药品名称：
TL139
作用靶点：
ALK/ROS1/NTRK融合
研发公司：
苏州韬略
药物介绍：
TL139是一款新一代NTRK/ROS1/ALK多靶点抑制剂。
适应症：
二线治疗ALK/ROS1/NTRK阳性实体瘤
招募信息（部分）：
ALK阳性，既往接受过≤2种ALK抑制剂的治疗（用过化疗没用过ALK抑制剂的也可以）
ROS1阳性，既往接受过≤1种ROS1抑制剂的治疗
NTRK阳性，接受一代NTRK抑制剂后进展（拉罗，恩曲，TL118）
05
HG030
药品名称：
HG030
作用靶点：
ALK/ROS1重排
研发公司：
成都先导
药物介绍：
HG030是新一代NTRK /ROS1双靶点酪氨酸激酶抑制剂。
适应症：
治疗NTRK/ROS1重排非小细胞肺癌
招募信息（部分）：
Ⅲ期或Ⅳ期非小细胞肺癌，存在ROS1重排；
04
RET
RET激酶的基因组改变包括融合和点突变，从而导致RET信号过度活细胞生长不受控制。RET融合和突变发生在多种肿瘤类型中，且发生频率不同。据统计，在非小细胞肺癌里面，大约1%-2%的患者有RET基因融合，在甲状腺髓样癌中超过60%的患者有RET基因突变，在乳头状甲状腺癌中10%的患者有RET基因融合.
01
HS-10365
药品名称：
HS-10365
作用靶点：
RET
研发公司：
豪森药业
药物介绍：
HS-10365是具有自主知识产权的1类创新药，它专门针对RET基因改变的实体瘤进行治疗。这款药物通过抑制RET酪氨酸激酶的活性，阻断肿瘤细胞的信号传导通路，从而有效抑制肿瘤细胞的生长和增殖，为患者带来新的治疗选择和希望。
适应症：
二线治疗RET融合阳性肺癌
招募信息（部分）：
经组织病理学或细胞学证实的复发、不可切除的局部晚期或转移的RET阳性非小细胞肺癌。
05
MET
MET 是一种络氨酸激酶受体，它的过度激活与肿瘤发生、发展、预后与转归密切相关。它在肺腺癌中发生率为3%，其最常见的变异类型是外显子14的供体位点剪接突变。近年来，MET抑制剂的研究层出不穷，其中沃利替尼、Tepotinib和Capmatinib（卡马替尼，又名INC280）是目前研究数据相对较多的3个药物。
01
伯瑞替尼
药品名称：
安达替尼（PLB1004）+伯瑞替尼
作用靶点：
c-Met过表达
研发公司：
鞍石生物
适应症：
EGFR-TKI治疗失败后伴c-Met过表达或c-Met扩增
招募信息（部分）：
经组织学或细胞学确诊的，经临床诊断为不能手术治疗且不能接受根治性同步放化疗的局部晚期（ⅢB/ⅢC期）、转移性或复发性（IV期）NSCLC的患者；
既往未接受过针对晚期/转移性疾病的任何系统性抗肿瘤治疗；
携带与EGFR-TKI敏感性相关的EGFR突变（包括外显子19缺失和外显子21 L858R突变）；
经中心实验室确认c-Met过表达：通过IHC检测，组织样本≥50%肿瘤细胞的染色强度3+；
02
谷美替尼
药品名称：
谷美替尼
作用靶点：
MET蛋白过表达
研发公司：
海和
药物介绍：谷美替尼（SCC244）
是一种国研高选择性 MET 抑制剂，够选择性抑制c-Met激酶活性，进而抑制肿瘤细胞的增殖、迁移和侵袭。在携带 MET 外显子 14 跳跃突变的非小细胞肺癌患者中表现出持久疗效。这款药物的上市为具有间质-上皮转化因子（MET）外显子14跳变的局部晚期或转移性非小细胞肺癌患者提供了新的治疗选择。
适应症：
一线治疗MET蛋白过表达的非小细胞肺癌。
招募信息（部分）：
c-Met+ NSCLC或是存在已证实的MET 基因过表达。
06
KRAS
RAS家族中的NRAS，HRAS和KRAS突变引起的癌症占所有人类癌症的近四分之一，使其成为与癌症相关的最常见基因突变之一。其中，KRAS是最常见的致癌基因（所有RAS突变的85％），存在于
90%的胰腺癌中，30-40%的结肠癌中，15-20%的肺癌中
（大多为非小细胞肺癌）。遗憾的是从发现这一靶点至今的30年里，没有任何一款直接针对KRAS突变的靶向药物获批。因此，人们一直认为KRAS是一种“坚不可摧”蛋白质。
01
GH21
药品名称：
GH21
作用靶点：
Kras G12c突变
研发公司：
勤浩医药
药物介绍：
GH21具有低脱靶风险、口服生物利用率高，并展现出较大的安全性窗口，是一种具有广阔开发前景的小分子抗肿瘤药物。临床前的数据表明，GH21与D-1553的联合使用在携带KRASG12C突变的肿瘤动物模型中展现出强大的药物效果，并且动物的耐受性良好，没有观察到增加的毒性。
适应症：
二线治疗KRAS突变阳性非小细胞肺癌
招募信息（部分）：
1、年龄≥18岁，男性或女性;
2、ECOG评分0~1分，预期寿命≥3个月;
3、标准治疗失败的KRAS+实体瘤
02
HRS-4642
药品名称：
HRS-4642
作用靶点：
Kras G12d突变
研发公司：
恒瑞医药
药物介绍：
HRS-4642是第一个具有良好临床疗效的KRASG12D抑制剂且耐受性良好，没有新的安全性信号。
适应症：
二线治疗KRAS阳性实体瘤
招募信息（部分）：
1、年龄：18~75，男性或女性;
2、ECOG评分0~1分，预期寿命≥3个月;
3、标准治疗失败的KRASG12D实体瘤
07
BRAF
BRAF突变是人类致癌的关键驱动因素之一。据报道， BRAF突变存在于多种常见类型癌症中，包括
黑色素瘤（40-50%）
、
甲状腺癌（29-83%）
、
结直肠癌 (CRC；10-20%)
和
非小细胞肺癌 (NSCLC；2-4%) ，
最常见的BRAF突变亚型是BRAF V600。
01
HL-085
药品名称：
HL-085胶囊联合维莫非尼
作用靶点：
BRAF V600E
研发公司：
科州生物
适应症：BRAF V600E
阳性肺癌
药物介绍：
科露平（妥拉美替尼/HL-085）是我国自主研发的首款高选择性的MEK抑制剂，2024年3月获批上市，成为全球首个且唯一获批针对NRAS突变晚期黑色素瘤适应症的MEK抑制剂，可与RAS-RAF-MEK-ERK信号通路中的MEK1/2结合，阻断下游信号通路的传导，从而抑制肿瘤的生长。
招募信息（部分）：
1.经病理组织学/细胞学确认的手术无法切除，局部晚期或转移性的 IIIb、IIIc、IV 期 NSCLC；
2.未经系统治疗或经过系统治疗的人群均可纳入；
3.基线时能够提供 BRAF V600E 突变的基因检测报告
未完待续！期待更多新药开花结果
过去十年，肺癌的靶向免疫治疗已经取得了长足的进展，逆转了晚期患者的生存期，除了上面正在招募的药物，还有更多的新药正在研发中，下一期我们将为病友们系统整理肺癌各靶点的全球研发进展，想接受治疗的患者可以申请专家会诊评估用药方案或参加方舟计划获得免费用药的机会。让我们拭目以待，期待更多新药早日上市，造福大众！
本文为全球肿瘤医生网原创，未经授权严禁转载
免疫疗法临床结果抗体药物偶联物临床研究申请上市
2025-02-06
PRINCETON, N.J.--(
BUSINESS WIRE
)--
Bristol Myers Squibb
(NYSE: BMY) today reports results for the fourth quarter and full year of 2024.
“
We made good progress in 2024, which was capped by a fourth quarter of strong topline growth driven by key products and important pipeline advancements. We also achieved the landmark U.S. approval of
Cobenfy
last year for the treatment of schizophrenia in adults, and we expect this medicine to have a meaningful impact on patients and the company as a new growth driver,” said
Christopher Boerner, Ph.D.
, board chair and chief executive officer, Bristol Myers Squibb. “
Our collective focus on execution has established a solid foundation to navigate the multi-year journey toward achieving top-tier sustainable growth and long-term shareholder returns.”
Fourth Quarter
$ in millions, except per share amounts
2024
2023
Change
Change
Excl. F/X**
Total Revenues
$12,342
$11,477
8%
9%
Earnings Per Share - GAAP*
0.04
0.87
(95)%
N/A
Earnings Per Share - Non-GAAP*
1.67
1.70
(2)%
N/A
Acquired IPRD Charge and Licensing Income Net Impact on Earnings Per Share
0.01
(0.20
)
N/A
N/A
*GAAP and Non-GAAP earnings per share include the net impact of Acquired IPRD charges and licensing income.
**See "Use of Non-GAAP Financial Information".
Full Year
$ in millions, except per share amounts
2024
2023
Change
Change
Excl. F/X**
Total Revenues
$48,300
$45,006
7%
9%
(Loss)/Earnings Per Share - GAAP*
(4.41
)
3.86
N/A
N/A
Earnings Per Share - Non-GAAP*
1.15
7.51
(85)%
N/A
Acquired IPRD Charge and Licensing Income Net Impact on Earnings Per Share
(6.39
)
(0.28
)
N/A
N/A
*GAAP and Non-GAAP earnings per share include the net impact of Acquired IPRD charges and licensing income.
**See "Use of Non-GAAP Financial Information".
FOURTH QUARTER RESULTS
All comparisons are made versus the same period in 2023 unless otherwise stated.
Bristol Myers Squibb posted fourth quarter revenues of $12.3 billion, an increase of 8%, or 9% when adjusted for foreign exchange impacts, primarily driven by the Growth Portfolio and higher demand for
Eliquis
, partially offset by the impact of generics on
Sprycel, Revlimid, Abraxane
and
Pomalyst
.
U.S. revenues increased 9% to $8.6 billion, primarily driven by higher demand for the Growth Portfolio and
Eliquis
, partially offset by the impact of generics within the Legacy Portfolio.
International revenues increased 5% to $3.7 billion, or 9% when adjusted for foreign exchange impacts, primarily driven by higher demand for the Growth Portfolio, partially offset by the impact of generics within the Legacy Portfolio.
On a GAAP basis, gross margin decreased from 76.1% to 61.0%, primarily driven by intangible asset impairment charges and product mix. On a non-GAAP basis, gross margin decreased from 76.4% to 74.0%, primarily due to product mix.
On a GAAP and non-GAAP basis, marketing, selling and administrative expenses remained relatively flat at $2.1 billion.
On a GAAP basis, research and development expenses increased 29% to $3.2 billion, primarily due to the impact of recent acquisitions and IPRD impairment charges. On a non-GAAP basis, research and development expenses increased 13% to $2.8 billion, primarily due to the impact of recent acquisitions.
On a GAAP and non-GAAP basis, Acquired IPRD decreased to $30 million from $600 million. On a GAAP and non-GAAP basis, licensing income was $48 million compared to $67 million.
On a GAAP basis, amortization of acquired intangible assets decreased 26% to $1.7 billion, primarily due to lower amortization expense related to
Revlimid
, partially offset by the RayzeBio acquisition in 2024.
On a GAAP basis, the effective tax rate was 56.6%, primarily due to the impact of intangible asset impairments and amortization of acquired intangible assets. In 2023, the income tax benefit was $88 million despite pre-tax earnings of $1.7 billion, primarily due to a valuation allowance reversal and foreign currency. On a non-GAAP basis, the effective tax rate changed from 14.9% to 19.9%, primarily due to jurisdictional earnings mix.
On a GAAP basis, the company reported net income attributable to Bristol Myers Squibb of $72 million, or $0.04 per share, during the fourth quarter of 2024 compared to net earnings of $1.8 billion, or $0.87 per share, for the same period a year ago. The company reported non-GAAP net earnings attributable to Bristol Myers Squibb of $3.4 billion, or $1.67 per share, during the fourth quarter of 2024 compared to $3.5 billion, or $1.70 per share, for the same period a year ago.
FOURTH QUARTER PRODUCT REVENUE HIGHLIGHTS
($ amounts in millions)
Quarter Ended December
31, 2024
% Change from Quarter
Ended December 31,
2023
% Change from
Quarter Ended
December 31,
2023 Ex-F/X**
U.S.
Int'l
(c)
WW
(d)
U.S.
Int'l
(c)
WW
(d)
Int'l
(c)
WW
(d)
Growth Portfolio
Opdivo
$
1,423
$
1,056
$
2,479
2%
7%
4%
15%
7%
Orencia
750
250
1,000
(1)%
9%
2%
15%
3%
Yervoy
428
247
675
26%
9%
19%
15%
22%
Reblozyl
445
102
547
65%
104%
71%
110%
72%
Opdualag
233
21
254
25%
>200%
34%
>200%
34%
Breyanzi
209
54
263
146%
>200%
160%
>200%
162%
Camzyos
201
22
223
142%
>200%
153%
>200%
153%
Zeposia
115
43
158
15%
30%
19%
33%
20%
Abecma
59
46
105
5%
5%
5%
5%
5%
Sotyktu
64
19
83
14%
171%
32%
171%
32%
Krazati
36
3
39
N/A
N/A
N/A
N/A
N/A
Augtyro
13
2
15
>200%
N/A
>200%
N/A
>200%
Cobenfy
10
—
10
N/A
N/A
N/A
N/A
N/A
Other Growth Products
(a)
186
326
512
13%
104%
58%
106%
59%
Total Growth Portfolio
4,172
2,191
6,363
19%
24%
21%
31%
23%
Legacy Portfolio
Eliquis
2,221
974
3,195
19%
(3)%
11%
(2)%
11%
Revlimid
1,169
170
1,339
(6)%
(17)%
(8)%
(15)%
(7)%
Pomalyst/Imnovid
685
138
823
9%
(48)%
(8)%
(47)%
(7)%
Sprycel
135
63
198
(67)%
(45)%
(62)%
(41)%
(61)%
Abraxane
91
83
174
(48)%
17%
(30)%
28%
(26)%
Other Legacy Products
(b)
123
127
250
46%
(14)%
8%
(15)%
7%
Total Legacy Portfolio
4,424
1,555
5,979
—%
(14)%
(4)%
(12)%
(3)%
Total Revenues
$
8,596
$
3,746
$
12,342
9%
5%
8%
9%
9%
**
See "Use of Non-GAAP Financial Information".
(a)
Includes
Nulojix, Onureg, Inrebic, Empliciti
and royalty revenue.
(b)
Includes other mature brands.
(c)
Beginning in 2024, Puerto Rico revenues are included in International revenues. Prior period amounts have been reclassified to conform to the current presentation.
(d)
Worldwide (WW) includes U.S. and International (Int'l).
FOURTH QUARTER PRODUCT REVENUE HIGHLIGHTS
Growth Portfolio
Growth Portfolio worldwide revenues increased to $6.4 billion compared to $5.3 billion in the prior year period, representing growth of 21% on a reported basis, or 23% when adjusted for foreign exchange impacts. Growth Portfolio revenues were primarily due to higher demand for
Reblozyl,
Breyanzi
,
Camzyos
,
Yervoy
and
Opdualag.
Legacy Portfolio
Revenues for the Legacy Portfolio in the fourth quarter were $6.0 billion compared to $6.2 billion in the prior year period, representing a decline of 4% on a reported basis and 3% when adjusted for foreign exchange impacts. Legacy Portfolio revenues were lower primarily due to the impact of generics on
Sprycel, Revlimid, Abraxane
and
Pomalyst
, partially offset by higher demand for
Eliquis
.
PRODUCT AND PIPELINE UPDATE
Neuroscience
Category
Asset
Milestone
Clinical &
Research
Cobenfy
TM
(xanomeline and trospium chloride)
Long-term data from the
Phase 3 EMERGENT-4 and EMERGENT-5
trials evaluating
Cobenfy
in adults with schizophrenia showed that
Cobenfy
was generally well tolerated over 52 weeks, with continued improvements in symptoms and a side effect profile consistent with prior trials of the treatment in this indication.
Oncology
Category
Asset
Milestone
Regulatory
Opdivo
®
(nivolumab)
+
Yervoy
®
(ipilimumab)
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA)
recommended
approval of
Opdivo
+
Yervoy
for the first-line treatment of adult patients with unresectable or advanced hepatocellular carcinoma. The recommendation is based on results of the Phase 3 CheckMate -9DW trial. The CHMP opinion will now be reviewed by the European Commission (EC), which has the authority to approve medicines for the European Union.
Augtyro
TM
(repotrectinib)*
The EC approved
Augtyro
, a next-generation tyrosine kinase inhibitor (TKI), as a treatment for adult patients with ROS1-positive advanced non-small cell lung cancer and for the treatment of adult and pediatric patients 12 years of age and older with advanced solid tumors expressing a NTRK gene fusion, and who have received a prior NTRK inhibitor, or have not received a prior NTRK inhibitor and treatment options not targeting NTRK provide limited clinical benefit, or have been exhausted. The approval is based on results from the TRIDENT-1 and CARE trials.
*Approval received on January 13, 2025, and announced today by the company.
Opdivo Qvantig
TM
(nivolumab and hydaluronidase-nyhy)
The U.S. Food and Drug Administration (FDA)
approved
Opdivo Qvantig
injection for subcutaneous use in most previously approved adult, solid tumor
Opdivo
indications as monotherapy, monotherapy maintenance after completion of
Opdivo
plus
Yervoy
combination therapy, or in combination with chemotherapy or cabozantinib. The approval is based on results from the Phase 3 randomized, open-label CheckMate -67T trial.
Opdivo
+
Yervoy
The EC
approved
Opdivo
plus
Yervoy
for the first-line treatment of adult patients with microsatellite instability-high or mismatch repair deficient unresectable or metastatic colorectal cancer (mCRC). The approval is based on results from the CheckMate -8HW trial.
Clinical &
Research
Opdivo
+
Yervoy
Results from an analysis of the
Phase 3 CheckMate -8HW
trial evaluating
Opdivo
plus
Yervoy
versus
Opdivo
monotherapy across all lines of therapy for microsatellite instability-high/mismatch repair-deficient mCRC demonstrated a statistically significant and clinically meaningful improvement at a median follow up of 47 months in the dual primary endpoint of progression-free survival as assessed by Blinded Independent Central Review.
Hematology
Category
Asset
Milestone
Clinical &
Research
Breyanzi
®
(lisocabtagene maraleucel)
Five-year overall survival data from the
Phase 1 TRANSCEND NHL 001
study supported deep and durable responses of
Breyanzi
in patients with relapsed or refractory large B-cell lymphoma (LBCL) with median overall survival (OS) of 27.5 months and an estimated OS rate at five years of 38 percent.
Breyanzi
continued to demonstrate an established safety profile with no new safety signals.
In addition, new circulating tumor DNA (ctDNA) from the
Phase 3 TRANSFORM
study supported the superiority of
Breyanzi
to achieve deeper responses over the former standard of care in second-line LBCL.
Regulatory
Breyanzi
The CHMP of the EMA
recommended
approval of
Breyanzi
for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) who have received two or more prior lines of systemic therapy. The recommendation is based on data from the Phase 2 TRANSCEND FL study. The CHMP opinion will now be reviewed by the EC.
Cardiovascular
Category
Asset
Milestone
Clinical & Research
Camzyos
®
(mavacamten)
In Europe, following an opinion from the CHMP of the EMA,
Camzyos
received a label update to reduce the frequency of required echocardiography monitoring once a patient treated for obstructive hypertrophic cardiomyopathy is on a stable dose.
In addition, the company is today announcing the receipt of an April Prescription Drug User Fee Act (PDUFA) goal date from the FDA in the same setting.
Immunology
Category
Asset
Milestone
Clinical & Research
Sotyktu
®
(deucravacitinib)
Results from the
Phase 3 POETYK PsA-1 and POETYK PsA-2
trials evaluating the efficacy and safety of
Sotyktu
in adults with active psoriatic arthritis (PsA) met their primary endpoint, with a significantly greater proportion of
Sotyktu
-treated patients achieving at least a 20 percent improvement in signs and symptoms of disease after 16 weeks of treatment compared with placebo.
In addition, both trials met secondary endpoints across PsA disease activity at Week 16. In both studies,
Sotyktu
was well-tolerated and demonstrated safety consistent with the established safety profile of
Sotyktu
observed in a Phase 2 PsA clinical trial and Phase 3 moderate-to-severe plaque psoriasis clinical trials.
FULL-YEAR FINANCIAL RESULTS
All comparisons are made versus the same period in 2023 unless otherwise stated.
Bristol Myers Squibb posted revenues of $48.3 billion, an increase of 7%, or 9% when adjusted for foreign exchange impacts, primarily driven by the Growth Portfolio and higher demand for
Eliquis
, partially offset by the impact of generics on
Sprycel, Revlimid
and
Abraxane
.
U.S. revenues increased 9%
to
$34.1 billion, primarily due to higher demand for the Growth Portfolio and
Eliquis
, partially offset by the impact of generics on
Sprycel, Revlimid
and
Abraxane
.
International revenues increased 3% to $14.2 billion, or 8.0% when adjusted for foreign exchange impacts, primarily due to demand for Growth Portfolio products, partially offset by the impact of generics within the Legacy Portfolio.
On a GAAP basis, gross margin decreased from 76.2% to 71.1%, primarily driven by intangible asset impairment charges and product mix. On a non-GAAP basis, gross margin decreased from 76.6% to 75.3%, primarily due to product mix.
On a GAAP and non-GAAP basis, marketing, selling and administrative expenses increased 8% to $8.4 billion and 4% to $8.0 billion, respectively. The increase is primarily due to the timing of spend and the impact of recent acquisitions.
On a GAAP basis, research and development expenses increased 20% to $11.2 billion, primarily due to the impact of recent acquisitions and IPRD impairment charges. On a non-GAAP basis, research and development expenses increased 7% to $9.8 billion, primarily due to the impact of recent acquisitions.
On a GAAP and non-GAAP basis, Acquired IPRD increased from $913 million to $13.4 billion driven by a one-time Acquired IPRD charge from the Karuna asset acquisition and SystImmune collaboration. On a GAAP and non-GAAP basis, licensing income was $122 million during the year compared to $142 million in 2023.
On a GAAP basis, amortization of acquired intangible assets decreased 2% to $8.9 billion, primarily due to lower amortization expense related to
Revlimid
, partially offset by the RayzeBio acquisition in 2024.
On a GAAP basis, income tax expense was $554 million despite a pre-tax loss of $8.4 billion, primarily due to a $12.1 billion non-tax deductible charge for the Karuna acquisition. The 2023 GAAP effective tax rate was impacted by a non-U.S. tax ruling on statutory impairment deductibility, changes in tax reserves, valuation allowances, and IRS guidance on non-U.S. R&D expense deductibility. On a non-GAAP basis, the effective tax rate increased from 14.7% to 56.8%, primarily due to the non-tax deductible charge.
The company reported on a GAAP basis net loss attributable to Bristol Myers Squibb of $8.9 billion, or $(4.41) per share, compared to earnings attributable to Bristol Myers Squibb of $8.0 billion, or $3.86 per share for the same period a year ago. On a non-GAAP basis the company reported net earnings attributable to Bristol Myers Squibb of $2.3 billion, or $1.15 per share, compared to earnings attributable to Bristol Myers Squibb of $15.6 billion, or $7.51 per share for the same period a year ago. In addition to the non-GAAP drivers noted above, non-GAAP EPS was impacted by higher interest expense.
FULL-YEAR PRODUCT REVENUE HIGHLIGHTS
($ amounts in millions)
Year Ended December
31, 2024
% Change from Year Ended
December 31, 2023
% Change from
Year Ended
December 31,
2023 Ex-F/X**
U.S.
Int'l
(c)
WW
(d)
U.S.
Int'l
(c)
WW
(d)
Int'l
(c)
WW
(d)
Growth Portfolio
Opdivo
$
5,350
$
3,954
$
9,304
2%
5%
3%
14%
7%
Orencia
2,770
912
3,682
2%
2%
2%
10%
4%
Yervoy
1,599
931
2,530
16%
8%
13%
15%
16%
Reblozyl
1,444
329
1,773
80%
61%
76%
65%
77%
Opdualag
870
58
928
41%
>200%
48%
>200%
48%
Breyanzi
591
156
747
95%
156%
105%
162%
106%
Camzyos
543
59
602
141%
>200%
161%
>200%
161%
Zeposia
403
163
566
26%
42%
30%
42%
30%
Abecma
242
164
406
(32)%
44%
(14)%
47%
(13)%
Sotyktu
190
56
246
21%
>200%
45%
>200%
46%
Krazati
118
8
126
N/A
N/A
N/A
N/A
N/A
Augtyro
36
2
38
>200%
N/A
>200%
N/A
>200%
Cobenfy
10
—
10
N/A
N/A
N/A
N/A
N/A
Other Growth Products
(a)
674
931
1,605
9%
58%
33%
61%
34%
Total Growth Portfolio
14,840
7,723
22,563
17%
16%
17%
24%
19%
Legacy Portfolio
Eliquis
9,631
3,702
13,333
14%
(1)%
9%
—%
9%
Revlimid
4,999
774
5,773
(4)%
(14)%
(5)%
(11)%
(5)%
Pomalyst/Imnovid
2,695
850
3,545
15%
(23)%
3%
(22)%
3%
Sprycel
983
303
1,286
(31)%
(40)%
(33)%
(36)%
(32)%
Abraxane
541
334
875
(23)%
11%
(13)%
25%
(8)%
Other Legacy Products
(b)
416
509
925
25%
(19)%
(4)%
(18)%
(3)%
Total Legacy Portfolio
19,265
6,472
25,737
4%
(10)%
—%
(8)%
1%
Total Revenues
$
34,105
$
14,195
$
48,300
9%
3%
7%
8%
9%
**
See "Use of Non-GAAP Financial Information".
(a)
Includes
Nulojix, Onureg, Inrebic, Empliciti
and royalty revenue.
(b)
Includes other mature brands.
(c)
Beginning in 2024, Puerto Rico revenues are included in International revenues. Prior period amounts have been reclassified to conform to the current presentation.
(d)
Worldwide (WW) includes U.S. and International (Int'l).
FULL-YEAR PRODUCT REVENUE HIGHLIGHTS
Growth Portfolio
Growth Portfolio worldwide revenues increased to $22.6 billion compared to $19.4 billion in the prior year period, representing growth of 17% on a reported basis, or 19% when adjusted for foreign exchange impacts. Growth Portfolio revenues were primarily driven by higher demand for
Reblozyl,
Breyanzi
,
Camzyos
and
Opdualag.
Legacy Portfolio
Revenues for the Legacy Portfolio remained relatively flat at $25.7 billion compared to $25.6 billion in the prior year period, and increased 1% when adjusted for foreign exchange impacts. Legacy Portfolio revenues were primarily driven by higher demand for
Eliquis
, offset by the impact of generics on
Sprycel,
Revlimid, Abraxane
and
Pomalyst
.
Update on Strategic Productivity Initiative
Bristol Myers Squibb is expanding its existing strategic productivity initiative to include approximately $2 billion in additional annualized cost savings by the end of 2027.
Under this expanded initiative, savings will be driven by changes in organizational design and efforts to enhance operational efficiency. These savings will be removed from our cost structure to contribute to a leaner, more efficient company while investing behind growth brands and promising areas of science.
Financial Guidance
Bristol Myers Squibb is providing key 2025 non-GAAP line-item guidance assumptions as outlined below.
We estimate total revenues to be approximately $45.5 billion, reflecting, as previously expected, the near-term impact of generics across
Revlimid
,
Pomalyst
,
Sprycel
and
Abraxane
, which we expect to result in a revenue decline of approximately 18-20% of the Legacy Portfolio. This is expected to be partially offset by the continued strength of our Growth Portfolio. This guidance also reflects an approximate $500 million expected negative impact to revenue due to foreign exchange.
2025 Non-GAAP
1
Line-Item Guidance
Total Revenues
(Reported & Ex-F/X)
~$45.5 billion
Gross Margin %
~72%
Operating Expenses
2
~$16 billion
Other Income/(Expense)
~$30 million
Tax Rate
~18%
Diluted EPS
$6.55-$6.85
1
See "Use of Non-GAAP Financial Information."
2
Operating Expenses = MS&A and R&D, excluding Acquired IPRD and Amortization of acquired intangible assets.
The 2025 financial guidance excludes the impact of any potential future strategic acquisitions, divestitures, specified items that have not yet been identified and quantified, and the impact of future Acquired IPRD charges. To the extent we have quantified the impact of significant R&D charges or other income resulting from upfront or contingent milestone payments in connection with asset acquisitions or licensing of third-party intellectual property rights, we may update this information from time to time on our website
www.bms.com
, in the "Investors" section. Non-GAAP guidance assumes current exchange rates. The financial guidance is subject to risks and uncertainties applicable to all forward-looking statements as described elsewhere in this press release.
A reconciliation of forward-looking non-GAAP measures, including non-GAAP EPS, to the most directly comparable GAAP measures is not provided because comparable GAAP measures for such measures are not reasonably accessible or reliable due to the inherent difficulty in forecasting and quantifying measures that would be necessary for such reconciliation. Namely, we are not, without unreasonable effort, able to reliably predict the impact of accelerated depreciation and impairment charges, legal and other settlements, gains and losses from equity investments and other adjustments. In addition, the company believes such a reconciliation would imply a degree of precision and certainty that could be confusing to investors. These items are uncertain, depend on various factors and may have a material impact on our future GAAP results. See "Cautionary Statement Regarding Forward-Looking Statements" and "Use of Non-GAAP Financial Information."
Conference Call Information
Bristol Myers Squibb will host a conference call today, Thursday, February 6, 2025, at 8:00 a.m. ET, during which company executives will review quarterly and annual financial results and address inquiries from investors and analysts. Investors and the general public are invited to listen to a live webcast of the call at
http://investor.bms.com
.
Investors and the public can register for the live conference call
here
. Those unable to register can access the live conference call by dialing in the U.S. toll-free 1-833-816-1116 or international +1 412-317-0705. Materials related to the call will be available at
http://investor.bms.com
prior to the start of the conference call.
A replay of the webcast will be available at
http://investor.bms.com
approximately three hours after the conference call concludes. A replay of the conference call will be available beginning at 11:30 a.m. ET on February 6, 2025, through 11:30 a.m. ET on February 20, 2025, by dialing in the U.S. toll free 1-877-344-7529 or international +1 412-317-0088, confirmation code: 5943651.
About Bristol Myers Squibb
Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at
BMS.com
or follow us on
LinkedIn
,
X
,
YouTube
,
Facebook
, and
Instagram
.
corporatefinancial-news
Use of Non-GAAP Financial Information
In discussing financial results and guidance, the company refers to financial measures that are not in accordance with U.S. Generally Accepted Accounting Principles (GAAP). The non-GAAP financial measures are provided as supplemental information to the financial measures presented in this press release that are calculated and presented in accordance with GAAP and are presented because management has evaluated the company’s financial results both including and excluding the adjusted items or the effects of foreign currency translation, as applicable, and believes that the non-GAAP financial measures presented portray the results of the company's baseline performance, supplement or enhance management's, analysts' and investors' overall understanding of the company’s underlying financial performance and trends and facilitate comparisons among current, past and future periods. In addition, non-GAAP gross margin, which is gross profit excluding certain specified items, as a percentage of revenues, non-GAAP operating margin, which is gross profit less marketing, selling and administrative expenses and research and development expenses excluding certain specified items as a percentage of revenues, non-GAAP operating expenses, which is marketing, selling and administrative and research and development expenses excluding certain specified items, non-GAAP marketing, selling and administrative expenses, which is marketing, selling and administrative expenses excluding certain specified items, and non-GAAP research and development expenses, which is research and development expenses excluding certain specified items, are relevant and useful for investors because they allow investors to view performance in a manner similar to the method used by our management and make it easier for investors, analysts and peers to compare our operating performance to other companies in our industry and to compare our year-over-year results.
This earnings release and the accompanying tables also provide certain revenues and expenses, as well as non-GAAP measures, excluding the impact of foreign exchange ("Ex-Fx"). We calculate foreign exchange impacts by converting our current-period local currency financial results using the prior period average currency rates and comparing these adjusted amounts to our current-period results. Ex-Fx financial measures are not accounted for according to GAAP because they remove the effects of currency movements from GAAP results.
Non-GAAP financial measures such as non-GAAP earnings and related EPS information are adjusted to exclude certain costs, expenses, gains and losses and other specified items that are evaluated on an individual basis after considering their quantitative and qualitative aspects and typically have one or more of the following characteristics, such as being highly variable, difficult to project, unusual in nature, significant to the results of a particular period or not indicative of past or future operating results. These items are excluded from non-GAAP earnings and related EPS information because the company believes they neither relate to the ordinary course of the company’s business nor reflect the company’s underlying business performance. Similar charges or gains were recognized in prior periods and will likely reoccur in future periods, including amortization of acquired intangible assets, including product rights that generate a significant portion of our ongoing revenue and will recur until the intangible assets are fully amortized, unwinding of inventory purchase price adjustments, acquisition and integration expenses, restructuring costs, accelerated depreciation and impairment of property, plant and equipment and intangible assets, costs of acquiring a priority review voucher, divestiture gains or losses, stock compensation resulting from acquisition-related equity awards, pension, legal and other contractual settlement charges, equity investment and contingent value rights fair value adjustments (including fair value adjustments attributed to limited partnership equity method investments), income resulting from the change in control of the Nimbus Therapeutics TYK2 Program and amortization of fair value adjustments of debt acquired from Celgene in our 2019 exchange offer, among other items. Deferred and current income taxes attributed to these items are also adjusted for considering their individual impact to the overall tax expense, deductibility and jurisdictional tax rates. Certain other significant tax items are also excluded such as the impact resulting from a non-U.S. tax ruling regarding the deductibility of a statutory impairment of subsidiary investments and release of income tax reserves relating to the Celgene acquisition.
Because the non-GAAP financial measures are not calculated in accordance with GAAP, they should not be considered superior to and are not intended to be considered in isolation or as a substitute for the related financial measures presented in the press release that are prepared in accordance with GAAP and may not be the same as or comparable to similarly titled measures presented by other companies due to possible differences in method and in the items being adjusted. We encourage investors to review our financial statements and publicly-filed reports in their entirety and not to rely on any single financial measure.
Reconciliations of the non-GAAP financial measures to the most comparable GAAP measures are provided in the accompanying financial tables and will also be available on the company’s website at
www.bms.com
. Within the accompanying financial tables presented, certain columns and rows may not add due to the use of rounded numbers. Percentages and EPS amounts presented are calculated from the underlying amounts.
A reconciliation of forward-looking non-GAAP measures, including non-GAAP EPS, to the most directly comparable GAAP measures is not provided because comparable GAAP measures for such measures are not reasonably accessible or reliable due to the inherent difficulty in forecasting and quantifying measures that would be necessary for such reconciliation. Namely, we are not, without unreasonable effort, able to reliably predict the impact of accelerated depreciation and impairment charges, legal and other settlements, gains and losses from equity investments and other adjustments. In addition, the company believes such a reconciliation would imply a degree of precision and certainty that could be confusing to investors. These items are uncertain, depend on various factors and may have a material impact on our future GAAP results.
Website Information
We routinely post important information for investors on our website, BMS.com, in the “Investors” section. We may use this website as a means of disclosing material, non-public information and for complying with our disclosure obligations under Regulation FD. Accordingly, investors should monitor the Investors section of our website, in addition to following our press releases, Securities and Exchange Commission (SEC) filings, public conference calls, presentations and webcasts. We may also use social media channels to communicate with our investors and the public about our company, our products and other matters, and those communications could be deemed to be material information. The information contained on, or that may be accessed through, our website or social media channels are not incorporated by reference into, and are not a part of, this document.
Cautionary Statement Regarding Forward-Looking Statements
This earnings release and the related attachments (as well as the oral statements made with respect to information contained in this release and the attachments) contain certain “forward-looking” statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, regarding, among other things, the company’s 2025 financial guidance, its Strategic Productivity Initiative, its business development and capital allocation strategy, anticipated developments in the company’s pipeline, expectations with respect to the company’s future market position and the projected benefits of the company’s alliances and other business development activities. These statements may be identified by the fact that they use words such as “should,” “could,” “expect,” “anticipate,” “estimate,” “target,” “may,” “project,” “guidance,” “intend,” “plan,” “believe,” “will” and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance, although not all forward-looking statements contain such terms. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements. No forward-looking statement can be guaranteed, and there is no assurance that the company will achieve its financial guidance and long-term targets, that the company’s future clinical studies will support the data described in this release, that the company’s product candidates will receive necessary clinical and manufacturing regulatory approvals, that the company’s pipeline products will prove to be commercially successful, that clinical and manufacturing regulatory approvals will be sought or obtained within currently expected timeframes, or that contractual milestones will be achieved.
Forward-looking statements are based on current expectations and projections about the company’s future financial results, goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, that are difficult to predict, may be beyond the company’s control and could cause the company’s future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. Such risks, uncertainties and other matters include, but are not limited to: increasing pricing pressures from market access, pharmaceutical pricing controls and discounting; market actions taken by private and government payers to manage drug utilization and contain costs; the company’s ability to retain patent and market exclusivity for certain products; regulatory changes that result in lower prices, lower reimbursement rates and smaller populations for whom payers will reimburse; changes under the 340B Drug Pricing Program; the company’s ability to obtain and maintain regulatory approval for its product candidates; the possibility of difficulties and delays in product introduction and commercialization; increasing industry competition; potential difficulties, delays and disruptions in manufacturing, distribution or sale of products; the company’s ability to identify potential strategic acquisitions, licensing opportunities or other beneficial transactions; failure to complete, or delays in completing, collaborations, acquisitions, divestitures, alliances and other portfolio actions and the failure to achieve anticipated benefits from such transactions and actions; exposure to litigation and/or regulatory actions or investigations; the impact of any healthcare reform and legislation or regulatory action in the United States and international markets; increasing market penetration of lower-priced generic products; the failure of the company’s suppliers, vendors, outsourcing partners, alliance partners and other third parties to meet their contractual, regulatory and other obligations; the impact of counterfeit or unregistered versions of the company’s products and from stolen products; product label changes or other measures that could result in declining sales; safety or efficacy concerns regarding the company’s products or any product in the same class as the company’s products; the risk of cyber-attacks and unauthorized disclosure of trade secrets or other confidential data; the company’s ability to execute its financial, strategic and operational plans; the company’s ability to attract and retain key personnel; the impact of the company’s significant indebtedness; political and financial instability of international economies and sovereign risk; interest rate and currency exchange rate fluctuations, credit and foreign exchange risk management; risks relating to the use of social media platforms; issuance of new or revised accounting standards; and risks relating to public health outbreaks, epidemics and pandemics.
Forward-looking statements in this earnings release should be evaluated together with the many risks and uncertainties that affect the company’s business and market, particularly those identified in the cautionary statement and risk factors discussion in the company’s Annual Report on Form 10-K for the year ended December 31, 2023, as updated by the company’s subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the SEC. The forward-looking statements included in this document are made only as of the date of this document and except as otherwise required by applicable law, the company undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise.
BRISTOL-MYERS SQUIBB COMPANY
CONSOLIDATED STATEMENTS OF EARNINGS
(Unaudited, dollars and shares in millions except per share data)
Three Months Ended
December 31,
Twelve Months Ended
December 31,
2024
2023
2024
2023
Net product sales
$
11,811
$
11,168
$
46,778
$
43,778
Alliance and other revenues
531
309
1,522
1,228
Total Revenues
12,342
11,477
48,300
45,006
Cost of products sold
(a)
4,812
2,745
13,968
10,693
Marketing, selling and administrative
2,136
2,073
8,414
7,772
Research and development
3,191
2,478
11,159
9,299
Acquired IPRD
30
600
13,373
913
Amortization of acquired intangible assets
1,693
2,278
8,872
9,047
Other (income)/expense, net
305
(371
)
893
(1,158
)
Total Expenses
12,167
9,803
56,679
36,566
(Loss)/Earnings Before Income Taxes
175
1,674
(8,379
)
8,440
Provision for Income Taxes
99
(88
)
554
400
Net (Loss)/Earnings
76
1,762
(8,933
)
8,040
Noncontrolling Interest
4
—
15
15
Net (Loss)/Earnings Attributable to BMS
$
72
$
1,762
$
(8,948
)
$
8,025
Weighted-Average Common Shares Outstanding:
Basic
2,029
2,027
2,027
2,069
Diluted
2,037
2,033
2,027
2,078
(Loss)/Earnings per Common Share:
Basic
$
0.04
$
0.87
$
(4.41
)
$
3.88
Diluted
0.04
0.87
(4.41
)
3.86
Other (income)/expense, net
Interest expense
(b)
$
496
$
316
$
1,947
$
1,166
Royalty income - divestitures
(284
)
(239
)
(1,104
)
(862
)
Royalty and licensing income
(204
)
(420
)
(736
)
(1,488
)
Provision for restructuring
77
44
635
365
Investment income
(114
)
(145
)
(478
)
(449
)
Integration expenses
70
62
284
242
Litigation and other settlements
13
3
84
(390
)
Acquisition expense
—
32
50
32
Intangible asset impairments
—
—
47
29
Equity investment (gains)/losses
205
(53
)
(16
)
160
Divestiture losses
10
—
15
—
Other
36
29
165
37
Other (income)/expense, net
$
305
$
(371
)
$
893
$
(1,158
)
(a) Excludes amortization of acquired intangible assets.
(b) Includes amortization of purchase price adjustments to Celgene debt.
BRISTOL-MYERS SQUIBB COMPANY
PRODUCT REVENUES
FOR THE THREE MONTHS ENDED DECEMBER 31, 2024 AND 2023
(Unaudited, dollars in millions)
Change vs. 2023
2024
2023
GAAP
Excl. F/X**
U.S.
Int'l
(c)
WW
(d)
U.S.
Int'l
(c)
WW
(d)
U.S.
Int'l
(c)
WW
(d)
U.S.
Int'l
(c)
WW
(d)
Growth Portfolio
Opdivo
$
1,423
$
1,056
$
2,479
$
1,401
$
986
$
2,387
2%
7%
4%
2%
15%
7%
Orencia
750
250
1,000
755
230
985
(1)%
9%
2%
(1)%
15%
3%
Yervoy
428
247
675
340
226
566
26%
9%
19%
26%
15%
22%
Reblozyl
445
102
547
270
50
320
65%
104%
71%
65%
110%
72%
Opdualag
233
21
254
186
4
190
25%
>200%
34%
25%
>200%
34%
Breyanzi
209
54
263
85
16
101
146%
>200%
160%
146%
>200%
162%
Camzyos
201
22
223
83
5
88
142%
>200%
153%
142%
>200%
153%
Zeposia
115
43
158
100
33
133
15%
30%
19%
15%
33%
20%
Abecma
59
46
105
56
44
100
5%
5%
5%
5%
5%
5%
Sotyktu
64
19
83
56
7
63
14%
171%
32%
14%
171%
32%
Krazati
36
3
39
—
—
—
N/A
N/A
N/A
N/A
N/A
N/A
Augtyro
13
2
15
1
—
1
>200%
N/A
>200%
>200%
N/A
>200%
Cobenfy
10
—
10
—
—
—
N/A
N/A
N/A
N/A
N/A
N/A
Other Growth Products
(a)
186
326
512
165
160
325
13%
104%
58%
13%
106%
59%
Total Growth Portfolio
4,172
2,191
6,363
3,498
1,761
5,259
19%
24%
21%
19%
31%
23%
Legacy Portfolio
Eliquis
2,221
974
3,195
1,872
1,002
2,874
19%
(3)%
11%
19%
(2)%
11%
Revlimid
1,169
170
1,339
1,244
206
1,450
(6)%
(17)%
(8)%
(6)%
(15)%
(7)%
Pomalyst/Imnovid
685
138
823
627
263
890
9%
(48)%
(8)%
9%
(47)%
(7)%
Sprycel
135
63
198
411
115
526
(67)%
(45)%
(62)%
(67)%
(41)%
(61)%
Abraxane
91
83
174
176
71
247
(48)%
17%
(30)%
(48)%
28%
(26)%
Other Legacy Products
(b)
123
127
250
84
147
231
46%
(14)%
8%
46%
(15)%
7%
Total Legacy Portfolio
4,424
1,555
5,979
4,414
1,804
6,218
—%
(14)%
(4)%
—%
(12)%
(3)%
Total Revenues
$
8,596
$
3,746
$
12,342
$
7,912
$
3,565
$
11,477
9%
5%
8%
9%
9%
9%
**
See "Use of Non-GAAP Financial Information".
(a)
Includes
Onureg
, Inrebic,
Nulojix
,
Empliciti
and royalty revenues.
(b)
Includes other mature brands.
(c)
Beginning in 2024, Puerto Rico revenues are included in International revenues. Prior period amounts have been reclassified to conform to the current presentation.
(d)
Worldwide (WW) includes U.S. and International (Int'l).
BRISTOL-MYERS SQUIBB COMPANY
PRODUCT REVENUES
FOR THE TWELVE MONTHS ENDED DECEMBER 31, 2024 AND 2023
(Unaudited, dollars in millions)
Change vs. 2023
2024
2023
GAAP
Excl. F/X**
U.S.
Int'l
(c)
WW
(d)
U.S.
Int'l
(c)
WW
(d)
U.S.
Int'l
(c)
WW
(d)
U.S.
Int'l
(c)
WW
(d)
Growth Portfolio
Opdivo
$
5,350
$
3,954
$
9,304
$
5,246
$
3,763
$
9,009
2%
5%
3%
2%
14%
7%
Orencia
2,770
912
3,682
2,709
892
3,601
2%
2%
2%
2%
10%
4%
Yervoy
1,599
931
2,530
1,379
859
2,238
16%
8%
13%
16%
15%
16%
Reblozyl
1,444
329
1,773
804
204
1,008
80%
61%
76%
80%
65%
77%
Opdualag
870
58
928
615
12
627
41%
>200%
48%
41%
>200%
48%
Breyanzi
591
156
747
303
61
364
95%
156%
105%
95%
162%
106%
Camzyos
543
59
602
225
6
231
141%
>200%
161%
141%
>200%
161%
Zeposia
403
163
566
319
115
434
26%
42%
30%
26%
42%
30%
Abecma
242
164
406
358
114
472
(32)%
44%
(14)%
(32)%
47%
(13)%
Sotyktu
190
56
246
157
13
170
21%
>200%
45%
21%
>200%
46%
Krazati
118
8
126
—
—
—
N/A
N/A
N/A
N/A
N/A
N/A
Augtyro
36
2
38
1
—
1
>200%
N/A
>200%
>200%
N/A
>200%
Cobenfy
10
—
10
—
—
—
N/A
N/A
N/A
N/A
N/A
N/A
Other Growth Products
(a)
674
931
1,605
620
591
1,211
9%
58%
33%
9%
61%
34%
Total Growth Portfolio
14,840
7,723
22,563
12,736
6,630
19,366
17%
16%
17%
17%
24%
19%
Legacy Portfolio
Eliquis
9,631
3,702
13,333
8,482
3,724
12,206
14%
(1)%
9%
14%
—%
9%
Revlimid
4,999
774
5,773
5,195
902
6,097
(4)%
(14)%
(5)%
(4)%
(11)%
(5)%
Pomalyst/Imnovid
2,695
850
3,545
2,339
1,102
3,441
15%
(23)%
3%
15%
(22)%
3%
Sprycel
983
303
1,286
1,422
508
1,930
(31)%
(40)%
(33)%
(31)%
(36)%
(32)%
Abraxane
541
334
875
702
302
1,004
(23)%
11%
(13)%
(23)%
25%
(8)%
Other Legacy Products
(b)
416
509
925
334
628
962
25%
(19)%
(4)%
25%
(18)%
(3)%
Total Legacy Portfolio
19,265
6,472
25,737
18,474
7,166
25,640
4%
(10)%
—%
4%
(8)%
1%
Total Revenues
$
34,105
$
14,195
$
48,300
$
31,210
$
13,796
$
45,006
9%
3%
7%
9%
8%
9%
**
See "Use of Non-GAAP Financial Information".
(a)
Includes
Onureg
, Inrebic,
Nulojix
,
Empliciti
and royalty revenues.
(b)
Includes other mature brands.
(c)
Beginning in 2024, Puerto Rico revenues are included in International revenues. Prior period amounts have been reclassified to conform to the current presentation.
(d)
Worldwide (WW) includes U.S. and International (Int'l).
BRISTOL-MYERS SQUIBB COMPANY
INTERNATIONAL REVENUES
(a)
FOREIGN EXCHANGE IMPACT (%)
(Unaudited)
Three Months Ended December 31, 2024
Twelve Months Ended December 31, 2024
Revenue
Change %
F/X %
Favorable/
(Unfavorable)
**
Revenue
Change %
Ex- F/X **
Revenue
Change %
F/X %
Favorable/
(Unfavorable)
**
Revenue
Change %
Ex- F/X **
Growth Portfolio
Opdivo
7%
(8)%
15%
5%
(9)%
14%
Orencia
9%
(6)%
15%
2%
(8)%
10%
Yervoy
9%
(6)%
15%
8%
(7)%
15%
Reblozyl
104%
(6)%
110%
61%
(4)%
65%
Opdualag
>200%
NM
>200%
>200%
NM
>200%
Breyanzi
>200%
NM
>200%
156%
(6)%
162%
Camzyos
>200%
NM
>200%
>200%
NM
>200%
Zeposia
30%
(3)%
33%
42%
—%
42%
Abecma
5%
—%
5%
44%
(3)%
47%
Sotyktu
171%
—%
171%
>200%
NM
>200%
Krazati
N/A
N/A
N/A
N/A
N/A
N/A
Augtyro
N/A
N/A
N/A
N/A
N/A
N/A
Cobenfy
N/A
N/A
N/A
N/A
N/A
N/A
Other Growth Products
(b)
104%
(2)%
106%
58%
(3)%
61%
Total Growth Portfolio
24%
(7)%
31%
16%
(8)%
24%
Legacy Portfolio
Eliquis
(3)%
(1)%
(2)%
(1)%
(1)%
—%
Revlimid
(17)%
(2)%
(15)%
(14)%
(3)%
(11)%
Pomalyst/Imnovid
(48)%
(1)%
(47)%
(23)%
(1)%
(22)%
Sprycel
(45)%
(4)%
(41)%
(40)%
(4)%
(36)%
Abraxane
17%
(11)%
28%
11%
(14)%
25%
Other Legacy Products
(c)
(14)%
1%
(15)%
(19)%
(1)%
(18)%
Total Legacy Portfolio
(14)%
(2)%
(12)%
(10)%
(2)%
(8)%
Total Revenues
5%
(4)%
9%
3%
(5)%
8%
NM
Not meaningful
**
See "Use of Non-GAAP Financial Information".
(a)
Beginning in 2024, Puerto Rico revenues are included in International revenues. Prior period amounts have been reclassified to conform to the current presentation.
(b)
Includes
Onureg
,
Nulojix
,
Empliciti
and royalty revenues.
(c)
Includes other mature brands.
BRISTOL-MYERS SQUIBB COMPANY
WORLDWIDE REVENUES
(a)
FOREIGN EXCHANGE IMPACT (%)
(Unaudited)
Three Months Ended December 31, 2024
Twelve Months Ended December 31, 2024
Revenue
Change %
F/X %
Favorable/
(Unfavorable)
**
Revenue
Change % Ex-
F/X **
Revenue
Change %
F/X %
Favorable/
(Unfavorable)
**
Revenue
Change % Ex-
F/X **
Growth Portfolio
Opdivo
4%
(3)%
7%
3%
(4)%
7%
Orencia
2%
(1)%
3%
2%
(2)%
4%
Yervoy
19%
(3)%
22%
13%
(3)%
16%
Reblozyl
71%
(1)%
72%
76%
(1)%
77%
Opdualag
34%
—%
34%
48%
—%
48%
Breyanzi
160%
(2)%
162%
105%
(1)%
106%
Camzyos
153%
—%
153%
161%
—%
161%
Zeposia
19%
(1)%
20%
30%
—%
30%
Abecma
5%
—%
5%
(14)%
(1)%
(13)%
Sotyktu
32%
—%
32%
45%
(1)%
46%
Krazati
N/A
N/A
N/A
N/A
N/A
N/A
Augtyro
>200%
NM
>200%
>200%
NM
>200%
Cobenfy
N/A
N/A
N/A
N/A
N/A
N/A
Other Growth Products
(b)
58%
(1)%
59%
33%
(1)%
34%
Total Growth Portfolio
21%
(2)%
23%
17%
(2)%
19%
Legacy Portfolio
Eliquis
11%
—%
11%
9%
—%
9%
Revlimid
(8)%
(1)%
(7)%
(5)%
—%
(5)%
Pomalyst/Imnovid
(8)%
(1)%
(7)%
3%
—%
3%
Sprycel
(62)%
(1)%
(61)%
(33)%
(1)%
(32)%
Abraxane
(30)%
(4)%
(26)%
(13)%
(5)%
(8)%
Other Legacy Products
(c)
8%
1%
7%
(4)%
(1)%
(3)%
Total Legacy Portfolio
(4)%
(1)%
(3)%
—%
(1)%
1%
Total Revenues
8%
(1)%
9%
7%
(2)%
9%
NM
Not meaningful
**
See "Use of Non-GAAP Financial Information".
(a)
Worldwide (WW) includes U.S. and International (Int'l).
(b)
Includes
Onureg
,
Nulojix
,
Empliciti
and royalty revenues.
(c)
Includes other mature brands.
BRISTOL-MYERS SQUIBB COMPANY
RECONCILIATION OF GAAP AND NON-GAAP GROWTH DOLLARS AND PERCENTAGES EXCLUDING FOREIGN EXCHANGE IMPACT
*
(Unaudited, dollars in millions)
THREE MONTHS
2024
2023
Change $
Change %
Favorable /
(Unfavorable)
F/X $ **
2024
Excl. F/X
**
Favorable /
(Unfavorable)
F/X % **
% Change
Excl. F/X
**
Revenues
$
12,342
$
11,477
$
865
8
%
$
(142)
$
12,484
(1)%
9%
Gross profit
7,530
8,732
(1,202
)
(14
)%
N/A
N/A
N/A
N/A
Gross profit excluding specified items
(a)
9,130
8,770
360
4
%
N/A
N/A
N/A
N/A
Gross margin
(b)
61.0
%
76.1
%
Gross margin excluding specified items
74.0
%
76.4
%
Marketing, selling and administrative
2,136
2,073
63
3
%
21
2,157
1%
4%
Marketing, selling and administrative excluding specified items
(a)
2,105
2,064
41
2
%
21
2,126
1%
3%
Research and development
3,191
2,478
713
29
%
8
3,199
—%
29%
Research and development excluding specified items
(a)
2,788
2,476
312
13
%
8
2,796
—%
13%
Operating margin
(c)
17.8
%
36.4
%
Operating margin excluding specified items
34.3
%
36.9
%
TWELVE MONTHS
2024
2023
Change $
Change %
Favorable /
(Unfavorable) F/X $ **
2024
Excl. F/X **
Favorable / (Unfavorable) F/X % **
% Change Excl. F/X
**
Revenues
$
48,300
$
45,006
$
3,294
7
%
$
(654)
$
48,954
(2)%
9%
Gross profit
34,332
34,313
19
—
%
N/A
N/A
N/A
N/A
Gross profit excluding specified items
(a)
36,351
34,488
1,863
5
%
N/A
N/A
N/A
N/A
Gross margin
(b)
71.1
%
76.2
%
Gross margin excluding specified items
75.3
%
76.6
%
Marketing, selling and administrative
8,414
7,772
642
8
%
89
8,503
1%
9%
Marketing, selling and administrative excluding specified items
(a)
7,992
7,678
314
4
%
89
8,081
1%
5%
Research and development
11,159
9,299
1,860
20
%
40
11,199
—%
20%
Research and development excluding specified items
(a)
9,782
9,112
670
7
%
40
9,822
1%
8%
Operating margin
(c)
30.6
%
38.3
%
Operating margin excluding specified items
38.5
%
39.3
%
*
Foreign exchange impacts were derived by converting our current-period local currency financial results using the prior period average currency rates and comparing these adjusted amounts to our current-period results.
**
See "Use of Non-GAAP Financial Information".
(a)
Refer to the Specified Items schedule below for further details.
(b)
Represents gross profit as a percentage of Revenues.
(c)
Operating margin represents gross profit less marketing, selling and administrative expenses and research and development expenses, as a percentage of Revenues.
BRISTOL-MYERS SQUIBB COMPANY
SPECIFIED ITEMS
(Unaudited, dollars in millions)
Three Months Ended
December 31,
Twelve Months
Ended December
31,
2024
2023
2024
2023
Inventory purchase price accounting adjustments
$
13
$
—
$
47
$
84
Intangible asset impairment
1,559
27
1,839
27
Site exit and other costs
28
11
133
64
Cost of products sold
1,600
38
2,019
175
Acquisition related charges
(a)
—
—
372
—
Site exit and other costs
31
9
50
94
Marketing, selling and administrative
31
9
422
94
IPRD impairments
390
—
980
80
Priority review voucher
—
—
—
95
Acquisition related charges
(a)
—
—
348
—
Site exit and other costs
13
2
49
12
Research and development
403
2
1,377
187
Amortization of acquired intangible assets
1,693
2,278
8,872
9,047
Interest expense
(b)
(12
)
(13
)
(49
)
(52
)
Equity investment (gain)/losses
204
(54
)
(18
)
152
Acquisition expenses
—
32
50
32
Integration expenses
70
62
284
242
Divestiture losses
10
—
15
—
Litigation and other settlements
—
—
61
(397
)
Provision for restructuring
77
44
635
365
Intangible asset impairment
—
—
47
29
Other
9
—
120
(6
)
Other (income)/expense, net
358
71
1,145
365
Increase to Earnings before income taxes
4,085
2,398
13,835
9,868
Income taxes on items above
(749
)
(695
)
(2,045
)
(1,639
)
Income tax reserve releases
—
—
(502
)
—
Income taxes attributed to a non-U.S. tax ruling
—
—
—
(656
)
Income taxes
(749
)
(695
)
(2,547
)
(2,295
)
Increase to net earnings
$
3,336
$
1,703
$
11,288
$
7,573
(a)
Includes cash settlement of unvested stock awards, and other related costs incurred in connection with the recent acquisitions of Karuna, RayzeBio and Mirati.
(b)
Includes amortization of purchase price adjustments to Celgene debt.
BRISTOL-MYERS SQUIBB COMPANY
RECONCILIATION OF CERTAIN GAAP LINE ITEMS TO CERTAIN NON-GAAP LINE ITEMS
(Unaudited, dollars and shares in millions except per share data)
Three Months Ended December 31,
2024
Twelve Months Ended December 31,
2024
GAAP
Specified
Items
(a)
Non-GAAP
GAAP
Specified
Items
(a)
Non-GAAP
Gross profit
$
7,530
$
1,600
$
9,130
$
34,332
$
2,019
$
36,351
Marketing, selling and administrative
2,136
(31
)
2,105
8,414
(422
)
7,992
Research and development
3,191
(403
)
2,788
11,159
(1,377
)
9,782
Amortization of acquired intangible assets
1,693
(1,693
)
—
8,872
(8,872
)
—
Other (income)/expense, net
305
(358
)
(53
)
893
(1,145
)
(252
)
Earnings/(Loss) before income taxes
175
4,085
4,260
(8,379
)
13,835
5,456
Provision for income taxes
99
749
848
554
2,547
3,101
Net earnings/(loss) attributable to BMS used for diluted EPS calculation
$
72
$
3,336
$
3,408
$
(8,948
)
$
11,288
$
2,340
Weighted-average common shares outstanding—diluted
2,037
2,037
2,037
2,027
2,032
2,032
Diluted earnings/(loss) per share
$
0.04
$
1.63
$
1.67
$
(4.41
)
$
5.56
$
1.15
Effective tax rate
56.6
%
(36.7
)%
19.9
%
(6.6
)%
63.4
%
56.8
%
Three Months Ended December 31,
2023
Twelve Months Ended December 31,
2023
GAAP
Specified
Items
(a)
Non-GAAP
GAAP
Specified
Items
(a)
Non-GAAP
Gross profit
$
8,732
$
38
$
8,770
$
34,313
$
175
$
34,488
Marketing, selling and administrative
2,073
(9
)
2,064
7,772
(94
)
7,678
Research and development
2,478
(2
)
2,476
9,299
(187
)
9,112
Amortization of acquired intangible assets
2,278
(2,278
)
—
9,047
(9,047
)
—
Other (income)/expense, net
(371
)
(71
)
(442
)
(1,158
)
(365
)
(1,523
)
Earnings before income taxes
1,674
2,398
4,072
8,440
9,868
18,308
Provision for income taxes
(88
)
695
607
400
2,295
2,695
Net earnings attributable to BMS used for diluted EPS calculation
$
1,762
$
1,703
$
3,465
$
8,025
$
7,573
$
15,598
Weighted-average common shares outstanding—diluted
2,033
2,033
2,033
2,078
2,078
2,078
Diluted earnings per share
$
0.87
$
0.83
$
1.70
$
3.86
$
3.65
$
7.51
Effective tax rate
(5.3
)%
20.2
%
14.9
%
4.7
%
10.0
%
14.7
%
(a) Refer to the Specified Items schedule above for further details. Effective tax rate on the Specified Items represents the difference between the GAAP and Non-GAAP effective tax rate.
BRISTOL-MYERS SQUIBB COMPANY
NET DEBT CALCULATION
AS OF DECEMBER 31, 2024 AND DECEMBER 31, 2023
(Unaudited, dollars in millions)
December 31,
2024
December 31,
2023
Cash and cash equivalents
$
10,346
$
11,464
Marketable debt securities - current
513
816
Marketable debt securities - non-current
320
364
Cash, cash equivalents and marketable debt securities
$
11,179
$
12,644
Short-term debt obligations
(2,046
)
(3,119
)
Long-term debt
(47,603
)
(36,653
)
Net debt position
$
(38,470
)
$
(27,128
)
临床结果临床3期上市批准财报临床2期
2025-01-27
2024年10月27日，国家药典委通辅包处张军副处长分享了2025版药典四部的修订和主要内容更新进展。
由于内容较多，本文撷取笔者关注的内容，尤其是会与创新药质量研究相关内容，进行分析，分享给到大家，不足之处，请多多指正。
中国药典2025版四部主要收载的内容包括：通用技术要求，指导原则和药用辅料品种的正文。
通用技术要求包括了药典中收载的通则和总论，规定了药典中收载的通用技术要求同样适用于未收载入药典的药品标准。这一点需要引起创新药质量研究同行的注意。
通则包括制剂通则、其他通则和通用检测方法等。
四部收载内容中的通用技术要求和指导原则对于创新药质量研究的程度水平会有影响和指导意义。辅料包材品种正文修订内容对创新药辅料和包材部分也会有影响，程度较小。
通用技术的修订对比如下，制剂通则未增加，但修订数量最多，达24个。通用检测方法中，光谱分析法、色谱法以及其它的检测方法多数有修订，同时光学分析方法、限量检查法和特性检查法分别新增了3个，这些新增和修订将对创新药质量标准的制定产生影响。
指导原则新增数量最大，达26个，尤其是分析方法验证通则9101，几乎要全面接受ICHQ2和Q14的基本思想，对比于新药质量研究的长远影响重大。
药用辅料的修订情况如下：
药包材的修订情况如下：
通则与指导原则的主要修订内容如下。
关于注射剂内容与ICH Q4B协调的内容，以及软膏剂乳膏剂定义的完善，新增了抑菌效力研究要求、流变学、体外释放、管同均匀度等评估要求。这些修订将对注射剂和软膏相关质量研究产生影响。
在指导原则的主要修订内容中，关注新增了注射剂可见异物控制指导原则，新增了吸入和鼻用制剂喷雾特性评价指导原则。
在指导原则中，修订了0816<残留溶剂>，新增加了0862<元素杂质>，修订了0931<溶出度与释放度测定法>等通则。
残留溶剂的修订内容思想是全面与ICH Q3C接轨，保持一致协调。元素杂质通则为新增，主要与Q3D保持一致协调，这是一个很大的进步，与USP保持了协调。药典中重金属的检测不再具有代表性。溶出方法通则的修订在制剂中非常重要，对于新药和仿制药的评价有着非常重要的影响。
针对微生物的检测，这一次药典的修订是不遗余力，紧跟国外药典技术要求，与国外药典保持协调统一。完善了微生物控制体系，新增了三个关于微生物的指导原则。
大力推动不可接受微生物的控制，如洋葱伯克霍尔德菌的控制，新增其检测方法。
针对药品标准物质，修订的通则，新增了分装和包装的要求。标准物质的管理是核查的常见检查项和高发缺陷项项目。这一次药典更新提出了具体的管理要求，帮助申请人加强标准物质的管理。
同时修订了标准物质研制指南导则。创新药上市申请时，对照品备案是必须要求，这一指南修订，帮助申请人合理地进行标准物质研制，同时参照中检院的注册检验原则，保持协调一致。
2025版药典删除了9011与9012指导原则，避免与CDE的相关指导原则重叠，保持一致的要求。对于9306<遗传毒性杂质控制指导原则>进行了修订，与修订后的M7原则保持一致。
药包材的修订变化非常大。2025版药将不以一品一标准的形式收载药包材标准，主要以指导原则+通用检测方法的形式收载，这将改变药包材以后的质量控制的要求。
结论：
2025版药典四部的修订，整体以完善为主、巩固全面、协调各方和创新提高。紧跟药品标准发展趋势，结合我国制药生产实际，扩大先进技术的应用，重点加强药品安全性和有效性的控制方法的研究与建立，充分发控中国药典的标准规范性和导向性作用。
新版药典紧跟国内外药典微生物和生物检定相关标准和当前监管法规的发展趋势，全面完善基于风险评估的微生物控制体系，强化药品质量全过程的控制要求。
作者精彩原创集锦
1、创新药研发中原料药工艺与沟通交流常见难点
2、创新药研发中「制剂工」常见难点
3、创新药研发中「变更」相关难点
4、创新药研发中「质量分析控制」相关难点（1）
5、创新药研发中「质量分析控制」相关难点（2）
6、创新药研发难点分析与CMC研究策略探讨
7、《已上市化学药品药学变更研究技术指导原则（试行）原料药变更的问答》浅析
8、FDA：原料药中亚硝胺风险评估的最新观点
9、亚硝胺「传奇」：5年来监管和制药界的反思
10、【学习笔记】2023年度CDE审评报告
11、FDA审评：吡托布鲁替尼的药学变更桥接(完)
12、CDE：ICH指南在国内的实施概况
13、「解读」FDA审评：repotrectinib胶囊5次CMC会议内容
14、FDA：IND阶段CMC关注点
15、药品注册检验难点与建议
16、最新 FDA 人用药物亚硝胺杂质指南更新的「底层」参考
17、不同国家地区注册检验差异对比
曾文亮 博士
近20年药物研发经验，擅长新药研发与注册申报，近5年积累了近十个小分子新药中美IND申报成功和两个1类抗肿瘤新药上市申报成功经验。先后任职于某大型CRO医药研发公司、USP大中华区研发中心和港资原料药厂等，主导过MNC质量研究项目、USP各论更新和药厂QC实验室通过国家GMP检查和WHO审计。
受中国医药保健品进出口商会邀请在二十二届世界制药原料药中国展（CPHI）主导策划了“小分子创新药质量研究和注册策略”沙龙并发表主题演讲；同时受专业药学论坛邀请发表了《创新药质量研究要点和案例分析》、《中美新药申报沟通交流常见问题和案例分析》、《亚硝胺杂质的FDA和EMA控制策略》、《分析方法开发，验证和转移的统计学评价》和《FDA483中清洁验证的典型案例分析》等十余次主题演讲。
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| NTRK融合阳性实体瘤 | 美国 | 2024-06-13 | |
| NTRK融合阳性实体瘤 | 美国 | 2024-06-13 | |
| ROS1阳性非小细胞肺癌 | 美国 | 2023-11-15 | |
| ROS1阳性非小细胞肺癌 | 美国 | 2023-11-15 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| HR阳性/HER2阴性小叶癌 | 临床2期 | 美国 | 2024-08-08 | |
| KRAS G12D突变实体瘤 | 临床2期 | 美国 | 2021-09-23 | |
| KRAS突变肿瘤 | 临床2期 | 美国 | 2021-09-23 | |
| NTRK融合阳性非小细胞肺癌 | 临床2期 | 中国 | 2021-05-10 | |
| NTRK融合阳性非小细胞肺癌 | 临床2期 | 中国 | 2021-05-10 | |
| NTRK融合阳性非小细胞肺癌 | 临床2期 | 中国香港 | 2021-05-10 | |
| NTRK融合阳性非小细胞肺癌 | 临床2期 | 中国香港 | 2021-05-10 | |
| NTRK融合阳性非小细胞肺癌 | 临床2期 | 中国台湾 | 2021-05-10 | |
| NTRK融合阳性非小细胞肺癌 | 临床2期 | 中国台湾 | 2021-05-10 | |
| 间变性大细胞淋巴瘤 | 临床2期 | 美国 | 2020-03-12 |
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临床结果
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适应症
分期
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查看全部结果
| 研究 | 分期 | 人群特征 | 评价人数 | 分组 | 结果 | 评价 | 发布日期 |
|---|
临床1/2期 | ROS1阳性非小细胞肺癌 ROS1 Positive | 127 | (ROS1 Inhibitor Naïve Patients) | 壓窪襯襯鏇窪範繭鑰鏇(醖簾範壓繭醖膚窪淵憲) = 蓋顧選鹹鹹簾範糧築衊 鹹選憲衊襯餘蓋憲齋蓋 (鑰顧鏇鹹廠鹹網製顧壓, 68 ~ 88) 更多 | 积极 | 2024-06-13 | |
(ROS1 Inhibitor Pretreated Patients) | 壓窪襯襯鏇窪範繭鑰鏇(醖簾範壓繭醖膚窪淵憲) = 積觸簾鏇鹽網壓願夢壓 鹹選憲衊襯餘蓋憲齋蓋 (鑰顧鏇鹹廠鹹網製顧壓, 25 ~ 52) 更多 | ||||||
临床1/2期 | NTRK融合阳性实体瘤 NTRK gene fusion-positive | 88 | (TKI-Naïve Patients) | 鹽夢簾糧築窪窪鏇衊觸(積醖齋鹽廠壓鏇築選積) = 顧構範憲築艱網鹽膚積 築膚鏇簾積遞夢獵鹹觸 (顧鹽選廠獵夢膚觸艱鏇, 41 ~ 73) 更多 | 积极 | 2024-06-13 | |
(TKI-Pretreated Patients) | 鹽夢簾糧築窪窪鏇衊觸(積醖齋鹽廠壓鏇築選積) = 鏇繭鑰鹹鹹衊醖夢窪壓 築膚鏇簾積遞夢獵鹹觸 (顧鹽選廠獵夢膚觸艱鏇, 35 ~ 65) 更多 | ||||||
临床1/2期 | 565 | Repotrectinib 160 mg QD for 14 days, then 160 mg BID | 憲膚選鏇簾簾鹹齋艱餘(壓夢顧憲夢憲製壓範窪) = 選觸夢廠艱艱製鑰簾願 齋範廠獵鏇願膚蓋餘簾 (鹽簾鹽簾網顧積願醖餘, 68 ~ 88) 更多 | 积极 | 2024-05-24 | ||
临床1/2期 | 9 | (Dose Level 1) | 蓋製醖憲窪壓製窪鏇醖(鹹糧遞淵鑰餘廠壓築襯) = 憲襯繭築淵繭醖衊膚顧 積網顧壓鹹構糧醖鏇蓋 (製夢廠窪憲糧鹽鬱觸願, 艱廠憲淵蓋糧積餘選醖 ~ 鬱簾觸鏇鏇簾鹽鑰鹹積) 更多 | - | 2024-04-02 | ||
(Dose Level 2) | 蓋製醖憲窪壓製窪鏇醖(鹹糧遞淵鑰餘廠壓築襯) = 窪窪淵餘鑰憲顧艱築顧 積網顧壓鹹構糧醖鏇蓋 (製夢廠窪憲糧鹽鬱觸願, 觸艱簾範艱餘積窪醖糧 ~ 夢艱繭齋窪襯積艱製鏇) 更多 | ||||||
临床1/2期 | ROS1阳性非小细胞肺癌 TKI-naïve | 71 | 餘淵繭艱壓鑰蓋製窪願(製願蓋鹹構餘築鏇鏇憲): OR = 1.53 (95% CI, 0.64 ~ 3.67) 更多 | 积极 | 2024-03-22 | ||
临床1/2期 | - | (ROS1+ TKI-naïve NSCLC) | 顧範憲製獵鹹窪蓋觸蓋(憲膚鏇鏇獵衊餘築遞鏇) = 顧艱壓積願艱蓋築製願 鹽網齋衊顧簾憲簾壓醖 (遞鏇壓範艱鑰壓壓願構, 27.4 ~ NR) 更多 | 积极 | 2024-01-08 | ||
(ROS1+ TKI-pretreated NSCLC with 1 prior TKI and 1 prior chemotherapy) | 繭壓網壓繭選網襯簾選(糧鑰顧齋網願製淵鹽夢) = 鑰鏇製製齋窪願蓋簾構 鏇蓋膚鹽鹹衊觸鏇壓膚 (蓋鹽選顧憲窪繭廠製觸 ) 更多 | ||||||
临床1/2期 | ROS1阳性非小细胞肺癌 ROS1+ | 71 | 鏇淵選衊膚鏇築選選壓(鏇淵築構顧衊鹹網獵鏇) = 製廠積繭淵齋襯構遞繭 襯醖獵範蓋壓蓋簾顧積 (齋網範繭遞遞齋願壓艱, 74 ~ 96) | 积极 | 2023-12-02 | ||
鏇淵選衊膚鏇築選選壓(鏇淵築構顧衊鹹網獵鏇) = 衊廠淵齋鏇淵廠膚繭糧 襯醖獵範蓋壓蓋簾顧積 (齋網範繭遞遞齋願壓艱, 16 ~ 57) | |||||||
临床1/2期 | ROS1阳性非小细胞肺癌 ROS1 Positive | 264 | 衊網齋鬱憲鏇齋製鏇獵(築衊選獵壓顧鬱鏇窪獵) = 淵鏇蓋顧餘窪夢鑰鹹繭 糧願鏇廠積艱鹹繭築糧 (範鬱鹹窪餘鏇願簾廠繭 ) | 积极 | 2023-11-15 | ||
(ROS1 Inhibitor Naïve Patient) | 鑰構顧範鹹範糧糧餘獵(醖壓繭遞廠膚艱鑰繭鏇) = 鬱選齋鑰築構鏇壓醖網 夢衊範築選積糧淵襯築 (襯遞壓鹽範艱膚餘範醖, 68 ~ 88) 更多 | ||||||
临床1/2期 | NTRK融合阳性实体瘤 NTRK fusion | 426 | (TKI-naïve cohort) | 簾衊選顧鑰糧襯淵網齋(壓憲獵醖觸鑰窪範網繭) = 選淵簾襯獵齋範選膚鬱 憲鹽襯繭網網網艱積築 (醖網繭齋鑰網齋壓製遞, 41–73) 更多 | 积极 | 2023-10-23 | |
(TKI-pretreated cohort) | 簾衊選顧鑰糧襯淵網齋(壓憲獵醖觸鑰窪範網繭) = 壓鏇遞範餘膚遞齋鹹願 憲鹽襯繭網網網艱積築 (醖網繭齋鑰網齋壓製遞, 35–65) 更多 | ||||||
临床1/2期 | ROS1阳性非小细胞肺癌 ROS1 Positive | 426 | 繭鑰夢齋鑰願齋廠壓壓(壓醖積蓋積繭膚衊憲窪) = 艱鏇憲糧窪廠獵艱憲鬱 鏇齋襯鑰蓋範獵衊築糧 (壓鬱襯製壓膚窪齋選顧 ) 更多 | 积极 | 2023-09-10 | ||
(TKI-naïve cohort) | 築齋繭構衊鏇積顧餘觸(構窪糧製膚壓餘襯鬱蓋) = 構夢範壓蓋網範夢窪鑰 夢艱鬱鑰製鏇遞鑰範膚 (獵繭糧遞網餘餘選觸鏇, 68 ~ 88) 更多 |
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