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What changed in Bristol Myers Squibb's 10-K — 2023 vs 2024

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Paragraph-level year-over-year comparison of Bristol Myers Squibb's 2023 and 2024 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2024 report.

+556 added−541 removedSource: 10-K (2025-02-12) vs 10-K (2024-02-13)

Top changes in Bristol Myers Squibb's 2024 10-K

556 paragraphs added · 541 removed · 372 edited across 9 sections

Item 1. Business

Business — how the company describes what it does

115 edited+29 added−56 removed132 unchanged
Biggest changeAt this stage of development, we cannot determine all intellectual property issues or all the patent protection that may, or may not, be available for these investigational compounds. 8 HEMATOLOGY PHASE I PHASE II PHASE III APPROVED INDICATIONS Investigational Compounds alnuctamab+mezigdomide --Relapsed/Refractory Multiple Myeloma Anti-SIRPα -- Hematologic Malignancies BCL6 LDD --Lymphoma BCMA NKE --Relapsed/Refractory Multiple Myeloma BET Inhibitor (BMS-986378)^ --Relapsed/Refractory Non-Hodgkin's Lymphoma CD33-GSPT1 ADC --Acute Myeloid Leukemia CD33 NKE --Acute Myeloid Leukemia CK1α Degrader --Hematologic Malignancies Dual Targeting BCMAxGPRC5D CAR T --Relapsed/Refractory Multiple Myeloma golcadomide^ --1L Diffuse Large B-cell Lymphoma GPRC5D CAR T --Relapsed/Refractory Multiple Myeloma Additional Indications BREYANZI --3L+ Chronic Lymphocytic Leukemia --Relapsed/Refractory Follicular Lymphoma --Relapsed/Refractory Marginal Zone Lymphoma --Relapsed/Refractory Mantle Cell Lymphoma REBLOZYL ª --A-Thalassemia Investigational Compounds BET Inhibitor (BMS-986158) -- 1L Myelofibrosis golcadomide --Relapsed/Refractory Non-Hodgkin's Lymphoma Additional Indications ABECMA ª --Newly Diagnosed Multiple Myeloma with Suboptimal Response post-ASCT REBLOZYL ª --1L NTD MDS Associated Anemia --1L TD MF Associated Anemia Investigational Compounds alnuctamab --Relapsed/Refractory Multiple Myeloma iberdomide --2L+ Multiple Myeloma --Post-Autologous Stem Cell Therapy Maintenance Newly Diagnosed Multiple Myeloma mezigdomide --2L+ Multiple Myeloma Kd --2L+ Multiple Myeloma Vd ABECMA --5L+ Multiple Myeloma --4L+ Multiple Myeloma --3L+ Multiple Myeloma BREYANZI --2L Large B-cell Lymphoma --3L+ Large B-cell Lymphoma EMPLICITI ª + POMALYST/IMNOVID --Relapsed/Refractory Multiple Myeloma EMPLICITI ª + REVLIMID --Relapsed/Refractory Multiple Myeloma IDHIFA -- Relapsed/Refractory Acute Myeloid Leukemia INREBIC --Myelofibrosis ONUREG --Post-Induction Acute Myeloid Leukemia Maintenance OPDIVO ª --Advanced Hodgkin Lymphoma POMALYST/IMNOVID --Multiple Myeloma --Relapsed/Refractory Multiple Myeloma --AIDS related Kaposi Sarcoma --HIV-negative Kaposi Sarcoma REBLOZYL ª --Transfusion-Dependent Beta-Thalassemia --MDS Previously treated with ESA --1L Transfusion-Dependent MDS-Associated Anemia REVLIMID --1L Multiple Myeloma --Mantle Cell Lymphoma --MDS --Multiple Myeloma --Previously treated Follicular Lymphoma --Relapsed/Refractory Adult T-cell Leukemia/Lymphoma SPRYCEL --1L CML --Pediatric ALL --Refractory CML 9 ONCOLOGY PHASE I PHASE II PHASE III APPROVED INDICATIONS Investigational Compounds Anti-CCR8^ --Solid Tumors Anti-ILT4^ --Solid Tumors AR LDD --1L, 2L+ Metastatic Castration-Resistant Prostate Cancer DGK Inhibitor --Solid Tumors Helios CELMoD -- Solid Tumors JNK Inhibitor --Solid Tumors MAGE A4/8 TCER ª # --Solid Tumors NME 1 --Prostate Cancer PRMT5 Inhibitor -- Solid Tumors SHP2 Inhibitor ª ^ --Solid Tumors TGFβ Inhibitor^ --Solid Tumors TIGIT Bispecific ª --Gastric Cancer Additional Indications AUGTYRO (repotrectinib) --NTRK Pan Tumor KRAZATI -- 1L NSCLC --3L+ Colorectal cancer nivolumab + relatlimab --1L Stage IV NSCLC --1L Hepatocellular Carcinoma Investigational Compounds Anti-CTLA-4 NF Probody Therapeutic --Lung Cancer --Colorectal Cancer Anti-Fucosyl GM1^ --Relapsed/Refractory Small Cell Lung Cancer Anti-IL8^ --Solid Tumors Anti-NGK2A^ --Non-Small Cell Lung Cancer BET Inhibitor (BMS-986378)^ --Solid Tumors farletuzumab-ecteribulin ª --Ovarian Cancer --Non-Small Cell Lung Cancer Additional Indications KRAZATI --1L NSCLC --2L Colorectal Cancer OPDIVO ª --Peri-adjuvant Muscle Invasive Urothelial Carcinoma --Adjuvant HCC --Peri-adjuvant NSCLC --Stage IB-IIIA Adjuvant NSCLC# OPDIVO ª + YERVOY ª --1L Muscle Invasive Urothelial Carcinoma --1L HCC --1L+ MSI-High CRC --Stage III Unresectable NSCLC OPDUALAG ª --Adjuvant Melanoma Investigational Compounds subcutaneous nivolumab + relatlimab + rHuPH20 ª --1L Melanoma subcutaneous nivolumab + rHuPH20 (multi-indications) ª --2L RCC ABRAXANE --Breast --Gastric --Locally Advanced or Metastatic NSCLC --Metastatic Breast Cancer --NSCLC --Pancreatic --Unresectable Pancreatic AUGTYRO (repotrectinib) --ROS1 NSCLC KRAZATI --Advanced NSCLC with KRAS G12C mutation OPDIVO ª --1L Metastatic Melanoma --1L Gastric --Esophageal Squamous Cell Carcinoma --1L Esophageal --Adjuvant Melanoma --Adjuvant Bladder --Adjuvant Esophageal/Gastroesophageal --Adjuvant Melanoma Stage IIB/C --Mesothelioma --Previously treated advanced RCC --Previously treated Gastric cancer (Japan, China) --Previously treated Metastatic Head & Neck --Previously treated Metastatic Melanoma --Previously treated Metastatic MSI-High CRC --Previously treated Metastatic Non-squamous NSCLC --Previously treated Metastatic Squamous NSCLC --Previously treated Metastatic Urothelial Cancer --Previously treated Esophageal Cancer --Neoadjuvant NSCLC OPDIVO ª + c abozantinib ª --Metastatic RCC OPDIVO ª + YERVOY ª --1L Metastatic Melanoma --1L Mesothelioma --1L NSCLC --1L RCC --Previously treated Metastatic MSI-High CRC --Previously treated HCC --1L Esophageal --1L Gastric OPDUALAG --1L Melanoma YERVOY ª --Adjuvant Melanoma --Metastatic Melanoma 10 IMMUNOLOGY PHASE I PHASE II PHASE III APPROVED INDICATIONS Investigational Compounds Anti-CD40 --Autoimmune Disease CD19 NEX T --Severe Refractory Systemic Lupus Erythematosus IL2-CD25 --Autoimmune Disease NME 2 --Autoimmune Disease PKCθ Inhibitor --Autoimmune Disease Additional Indications SOTYKTU --Alopecia Areata --Discoid Lupus Erythematosus Investigational Compounds afimetoran --Systemic Lupus Erythematosus TYK2 Inhibitor (BMS-986322) --Moderate-to-Severe Psoriasis Additional Indications SOTYKTU --Psoriatic Arthritis --Systemic Lupus Erythematosus --Sjögren's Syndrome ZEPOSIA --Crohn’s Disease Investigational Compounds cendakimab --Eosinophilic Esophagitis --Eosinophilic Gastroenteritis* LPA1 Antagonist --Idiopathic Pulmonary Fibrosis --Progressive Pulmonary Fibrosis obexelimab # --IgG4-Related Disease ORENCIA --Active Polyarticular JIA --Early Rheumatoid Arthritis --JIA Intravenous --JIA Subcutaneous --Psoriatic Arthritis --RA Auto injector --RA Intravenous --RA Subcutaneous --Acute Graft versus Host Disease SOTYKTU --Moderate-to-Severe Psoriasis ZEPOSIA --Relapsing Multiple Sclerosis --Moderate-to-Severe Ulcerative Colitis CARDIOVASCULAR PHASE I PHASE II PHASE III APPROVED INDICATIONS Investigational Compounds FXIa Inhibitor --Thrombotic Disorders Additional Indications CAMZYOS --Heart Failure with Preserved Ejection Fraction (HFpEF) Investigational Compounds danicamtiv --Genetic Dilated Cardiomyopathy MYK-224 --Obstructive Hypertrophic Cardiomyopathy --Heart Failure with Preserved Ejection Fraction (HFpEF) Additional Indications CAMZYOS --Non-obstructive Hypertrophic Cardiomyopathy Investigational Compounds milvexian ª --Acute Coronary Syndrome# --Atrial Fibrillation# --Secondary Stroke Prevention (SSP) # CAMZYOS --Symptomatic Obstructive Hypertrophic Cardiomyopathy ELIQUIS ª --Stroke Prevention in Atrial Fibrillation --Venous Thromboembolism Prevention --Orthopedic Surgery --Venous Thromboembolism Treatment 11 NEUROSCIENCE PHASE I Investigational Compounds Anti-MTBR-Tau --Alzheimer's Disease CD19 NEX T --Multiple Sclerosis eIF2b Activator ª --Neuroscience FAAH/MGLL Dual Inhibitor --Neuroscience TYK2 Inhibitor (BMS-986465) --Neuroinflammation Disorders Note: Above pipeline excludes clinical collaborations ª Development Partnerships: ABECMA : 2seventy bio; farletuzumab ecteribulin: Eisai; rHuPH20: Halozyme; MAGEA4/8 TCER: Immatics; milvexian: Janssen Pharmaceuticals Inc., a Johnson & Johnson company ; OPDIVO , YERVOY , OPDUALAG in Japan: Ono; PKCθ Inhibitor: Exscientia; REBLOZYL : Merck; SHP2 Inhibitor: BridgeBio Pharma; TIGIT Bispecific: Agenus; obexelimab: Zenas BioPharma in Japan, South Korea, Taiwan, HK, Singapore, and Australia ^ Trial(s) exploring various combinations # Partner-run study * Japan only The following are our registrational study readouts anticipated through 2024/2025: Oncology Immunology Asset Tumor Trial Asset Disease Trial Krazati 1L NSCLC TPS KRYSTAL-17 cendakimab EoE IM042-P04 Krazati 2L CRC KRYSTAL-10 Sotyktu PsA POETYK-PsA-1 Krazati 2L+ Mutated NSCLC KRYSTAL-12* Sotyktu PsA POETYK-PsA-2 Opdivo Adjuvant HCC CM-9DX Zeposia Crohn's Disease YELLOWSTONE (Induction -1) Opdivo Peri-adjuvant MIUC CM-078 Zeposia Crohn's Disease YELLOWSTONE (Induction-2) Hematology CV Asset Disease Trial Asset Disease Trial Breyanzi Relapsed/Refractory MZL TRANSCEND Camzyos nHCM ODYSSEY-HCM Reblozyl 1L TD MF Associated Anemia INDEPENDENCE * Confirmatory trial 12 Alliances We enter into alliance arrangements with third parties for the development and commercialization of specific products or drug candidates in our therapeutic areas of focus.
Biggest changeAt this stage of development, we cannot determine all intellectual property issues or all the patent protection that may, or may not, be available for these investigational compounds. 9 HEMATOLOGY PHASE I PHASE II PHASE III APPROVED INDICATIONS Investigational Compounds BCL6 LDD --Lymphoma CD33-GSPT1 ADC --Acute Myeloid Leukemia CK1α Degrader --Hematologic Malignancies Dual Targeting BCMAxGPRC5D CAR T --Relapsed/Refractory Multiple Myeloma HbF Activating CELMoD --Sickle Cell Disease Additional Indications BREYANZI --Relapsed/Refractory Marginal Zone Lymphoma REBLOZYL ª --A-Thalassemia Investigational Compounds arlo-cel (GPRC5D CAR T) --Relapsed/Refractory Multiple Myeloma golcadomide --Relapsed/Refractory Follicular Lymphoma Additional Indications REBLOZYL ª --1L NTD Myelodysplastic Syndrome Associated Anemia --1L TD Myelofibrosis Associated Anemia Investigational Compounds arlo-cel (GPRC5D CAR T) --2-4L Multiple Myeloma golcadomide --High Risk 1L Large B-cell Lymphoma iberdomide --2L+ Multiple Myeloma --Post-Autologous Stem Cell Therapy Maintenance Newly Diagnosed Multiple Myeloma mezigdomide --2L+ Multiple Myeloma Kd --2L+ Multiple Myeloma Vd ABECMA --3L+ Triple-Class Exposed Relapsed/Refractory Multiple Myeloma BREYANZI --2L+ Large B-cell Lymphoma --3L+ CLL/SLL --3L+ FL --3L+ MCL EMPLICITI + POMALYST/IMNOVID --Relapsed/Refractory Multiple Myeloma EMPLICITI + REVLIMID --Relapsed/Refractory Multiple Myeloma IDHIFA -- Relapsed/Refractory Acute Myeloid Leukemia INREBIC --Myelofibrosis ONUREG --Post-Induction Acute Myeloid Leukemia Continued Treatment/Maintenance OPDIVO ª --Relapsed/Refractory Classical Hodgkin Lymphoma POMALYST/IMNOVID --Relapsed/Refractory Multiple Myeloma --AIDS related Kaposi Sarcoma --HIV-negative Kaposi Sarcoma REBLOZYL ª --Transfusion-Dependent Beta-Thalassemia Associated Anemia --MDS RS or MDS/MPN-RS-T Adult Patients and Previously Treated with ESA --MDS Associated Anemia in ESA naïve patients who may require RBC Transfusion REVLIMID --Mantle Cell Lymphoma --MDS --Multiple Myeloma --Follicular Lymphoma --Marginal Zone Lymphoma SPRYCEL --1L CML --Acute Lymphoblastic Leukemia with Resistance or Intolerance to Prior Therapy --Refractory CML 10 ONCOLOGY PHASE I PHASE II PHASE III APPROVED INDICATIONS Investigational Compounds Anti-CCR8 --Solid Tumors BMS-986460 --Prostate Cancer BMS-986463 --Solid Tumors BMS-986482 --Solid Tumors BMS-986484 --Solid Tumors BMS-986488 --Solid Tumors BMS-986490 --Solid Tumors HELIOS CELMoD -- Solid Tumors iza-bren (EGFRxHER3 ADC) ª --1L NSCLC# --Metastatic NSCLC --Solid Tumors# PRMT5 Inhibitor -- Solid Tumors RYZ101 --Extensive Stage SCLC --HR+/HER2- Unresectable Metastatic Breast Cancer RYZ801 --Hepatocellular Carcinoma SOS1 Inhibitor --Solid Tumors Additional Indications KRAZATI ª -- 1L NSCLC PD-L1 Additional Indications KRAZATI ª --1L NSCLC PD-L1≥50% --2L Colorectal Cancer OPDIVO ª --Adjuvant Hepatocellular Carcinoma --Peri-adjuvant Muscle Invasive Urothelial Carcinoma OPDIVO ª + YERVOY ª --1L Hepatocellular Carcinoma OPDUALAG ª --Adjuvant Stage III/IV Melanoma Investigational Compounds AR LDD --Metastatic Castration-Resistant Prostate Cancer atigotatug (Anti-Fucosyl GM1) + nivolumab --1L Extensive Stage SCLC nivolumab + relatlimab HD ª --1L NSCLC PD-L1≥1% RYZ101 --2L+ SSTR2+ Gastroenteropancreatic Neuroendocrine Tumors subcutaneous nivolumab + relatlimab + rHuPH20 ª --1L Melanoma ABRAXANE --Gastric (Japan Only) --Locally Advanced or Metastatic NSCLC --Metastatic Breast Cancer AUGTYRO ª -- ROS1+ NSCLC --NTRK-Positive Locally Advanced or Metastatic Solid Tumors KRAZATI ª -- 2L+ KRASG12C-mutated Advanced NSCLC --KRASG12C-mutated CRC after prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy OPDIVO ª - - Metastatic Melanoma --1L Metastatic Gastric, Gastroesophageal Junction, and Esophageal Adenocarcinoma --1L Metastatic Esophageal --1L MIUC cis-eligible --Adjuvant Melanoma --Adjuvant Urothelial Carcinoma --Adjuvant Esophageal/Gastroesophageal --Neoadjuvant NSCLC --Perioperative NSCLC --Previously treated advanced RCC --Previously treated Gastric cancer (Japan) --Previously treated Metastatic Head & Neck --Previously treated Metastatic MSI-High CRC --Previously treated Metastatic NSCLC --Previously treated Metastatic Urothelial Cancer --Previously treated Metastatic Esophageal Cancer OPDIVO QVANTIG --Indicated for subcutaneous use in most previously approved adult, solid tumor Opdivo indications OPDIVO ª + c abozantinib ª - -1L Advanced RCC OPDIVO ª + YERVOY ª --1L Metastatic Melanoma --1L Mesothelioma --1L Metastatic NSCLC --1L Advanced RCC --1L+ MSI-High CRC --Previously treated Metastatic MSI-High CRC --Previously treated HCC --1L Esophageal OPDUALAG - -1L Melanoma YERVOY ª - -Adjuvant Melanoma --Metastatic Melanoma 11 IMMUNOLOGY PHASE I PHASE II PHASE III APPROVED INDICATIONS Investigational Compounds BMS-986454 --Autoimmune Disease CD19 NEX T --Autoimmune Diseases --Severe Refractory Systemic Lupus Erythematosus IL2-CD25 --Autoimmune Disease PKCθ Inhibitor ª --Autoimmune Disease Additional Indications SOTYKTU --Discoid Lupus Erythematosus Investigational Compounds afimetoran --Systemic Lupus Erythematosus BMS-986322 (TYK2 Inhibitor) --Moderate-to-Severe Psoriasis Additional Indications SOTYKTU --Psoriatic Arthritis --Systemic Lupus Erythematosus --Sjögren's Syndrome Investigational Compounds admilparant (LPA1 Antagonist) --Idiopathic Pulmonary Fibrosis --Progressive Pulmonary Fibrosis obexelimab ª --IgG4-Related Disease ORENCIA --Moderate-to-Severe JIA Intravenous --Moderate-to-Severe JIA Subcutaneous --Psoriatic Arthritis --Moderate-to-Severe RA Auto injector --Moderate-to-Severe RA Intravenous --Moderate-to-Severe RA Subcutaneous --Prophylaxis of Acute Graft versus Host Disease SOTYKTU --Adults with Moderate-to-Severe Plaque Psoriasis ZEPOSIA --Relapsing forms of Multiple Sclerosis --Moderate-to-Severe UC CARDIOVASCULAR PHASE II PHASE III APPROVED INDICATIONS Investigational Compounds MYK-224 --Heart Failure with Preserved Ejection Fraction Additional Indications CAMZYOS --Non-Obstructive Hypertrophic Cardiomyopathy Investigational Compounds milvexian ª --Acute Coronary Syndrome# --Atrial Fibrillation# --Secondary Stroke Prevention# CAMZYOS --Symptomatic NHYA Class II-III Obstructive Hypertrophic Cardiomyopathy ELIQUIS --Stroke Risk Reduction in Non-Valvular Atrial Fibrillation --Treatment of Venous Thromboembolism and Risk Reduction after Initial Therapy --Prophylaxis of Deep Vein Thrombosis after Hip or Knee Replacement Surgery 12 NEUROSCIENCE PHASE I PHASE II PHASE III APPROVED INDICATIONS Investigational Compounds BMS-986495 ª -- Neurodegenerative Diseases CD19 NEX T --Multiple Sclerosis --Myasthenia Gravis eIF2B Activator --Alzheimer's Disease TRPC4/5 Inhibitor --Mood and Anxiety Disorders Investigational Compounds Anti-MTBR Tau --Alzheimer's Disease FAAH/MGLL Dual Inhibitor --Alzheimer's Disease Agitation --Multiple Sclerosis Spasticity Additional Indications COBENFY --Adjunctive Schizophrenia --Psychosis in Alzheimer's Disease COBENFY --Adults with Schizophrenia Note: Above pipeline excludes clinical collaborations ª Development Partnerships: AUGTYRO: Zai Lab; BMS-986495: Prothena; COBENFY : Zai Lab; iza-bren (EGFRxHER3 ADC): SystImmune; KRAZATI : Zai Lab; milvexian: Johnson & Johnson; obexelimab: Zenas BioPharma; OPDIVO , YERVOY , OPDUALAG, nivolumab + relatlimab HD, Anti-CCR8 + nivolumab: Ono; PKCθ Inhibitor: Exscientia; REBLOZYL : Merck; rHuPH20: Halozyme # Partner-run study The following are our registrational study readouts anticipated through 2025/2026: Oncology Immunology Asset Tumor Trial Asset Disease Trial Opdivo Adjuvant HCC CheckMate -9DX Sotyktu SLE POETYK SLE-1 Opdivo Peri-adjuvant MIUC CA017-078 Sotyktu SLE POETYK SLE-2 Opdualag Adjuvant Stage III/IV Melanoma RELATIVITY-098 admilparant IPF ALOFT-IPF Opdualag 1L Melanoma SC RELATIVITY-127 obexelimab IgG4-Related Disease INDIGO Krazati 2L CRC KRYSTAL-10 Krazati 2L+ Mutated NSCLC KRYSTAL-12* Cardiovascular RYZ101 2L+ SSTR2+ GEP-NETs ACTION-1 Asset Disease Trial Camzyos nHCM ODYSSEY-HCM Hematology milvexian SSP LIBREXIA-STROKE Asset Disease Trial milvexian ACS LIBREXIA-ACS Breyanzi Relapsed/Refractory MZL TRANSCEND arlo-cel RRMM QUINTESSENTIAL Neuroscience iberdomide 2L+ MM EXCALIBER Asset Disease Trial mezigdomide 2L+ MM Vd SUCCESSOR-1 Cobenfy Adjunctive Schizophrenia ARISE mezigdomide 2L+ MM Kd SUCCESSOR-2 Cobenfy Psychosis in Alzheimer's Disease ADEPT-1 Reblozyl TD & NTD A-Thalassemia CA056-015# Cobenfy Psychosis in Alzheimer's Disease ADEPT-2 Reblozyl 1L TD MF Associated Anemia INDEPENDENCE Cobenfy Psychosis in Alzheimer's Disease ADEPT-4 * Confirmatory Trial # Ex-U.S.
For further discussion on the IRA, refer to “Item 1. Business—Government Regulation.” We are also now required to comply with state laws that seek additional transparency into the cost of prescription drugs. We are monitoring efforts by states to seek additional rebates and limit state spending on drugs in light of budget pressures.
For further discussion on the IRA, refer to “Item 1. Business—Government Regulation.” We are also required to comply with state laws that seek additional transparency into the cost of prescription drugs. We are monitoring efforts by states to seek additional rebates and limit state spending on drugs in light of budget pressures.
The possible extension to 11 years is available if the innovator, during the first eight years of the marketing authorization, obtains an additional indication that is of significant clinical benefit in comparison with existing treatments. In contrast to the U.S., patents in the EU are not listed with regulatory authorities.
The possible extension to 11 years is available if the innovator, during the first eight years of the marketing authorization, obtains an additional indication that is of significant clinical benefit in comparison with existing treatments. 5 In contrast to the U.S., patents in the EU are not listed with regulatory authorities.
Management’s Discussion and Analysis of Financial Condition and Results of Operations—GTN Adjustments” and “—Critical Accounting Policies.” Sources and Availability of Raw Materials In general, we purchase our raw materials, components and supplies required for the manufacturing of our products in the open market.
Management’s Discussion and Analysis of Financial Condition and Results of Operations—GTN Adjustments” and “—Critical Accounting Policies.” 19 Sources and Availability of Raw Materials In general, we purchase our raw materials, components and supplies required for the manufacturing of our products in the open market.
We maintain records to demonstrate the quality and integrity of data, technical information and production processes. Control of production processes involves established specifications and standards for raw materials, components, ingredients, equipment and facilities, manufacturing methods and operations, packaging materials and labeling.
We maintain records to demonstrate the quality and integrity of data, technical information and production processes. 20 Control of production processes involves established specifications and standards for raw materials, components, ingredients, equipment and facilities, manufacturing methods and operations, packaging materials and labeling.
Under Project Orbis, earlier approvals from the Australian Therapeutic Goods Administration (“TGA”), Health Canada and the United Kingdom’s Medicines and Healthcare products Regulatory Agency were received on the combination of Opdivo given with three cycles of platinum-doublet chemotherapy in 2022. 16 The FDA mandates that drugs be manufactured, packaged and labeled in conformity with cGMP established by the FDA.
Under Project Orbis, earlier approvals from the Australian Therapeutic Goods Administration (“TGA”), Health Canada and the United Kingdom’s Medicines and Healthcare products Regulatory Agency were received on the combination of Opdivo given with three cycles of platinum-doublet chemotherapy in 2022. 17 The FDA mandates that drugs be manufactured, packaged and labeled in conformity with cGMP established by the FDA.
Such actions may result in the imposition of civil and criminal sanctions, which may include fines, penalties and injunctive or administrative remedies. 17 The U.S. healthcare industry is subject to various government-imposed laws and regulations authorizing prices or price controls that have and will continue to have an impact on our total revenues.
Such actions may result in the imposition of civil and criminal sanctions, which may include fines, penalties and injunctive or administrative remedies. 18 The U.S. healthcare industry is subject to various government-imposed laws and regulations authorizing prices or price controls that have and will continue to have an impact on our total revenues.
Specific aspects of the law governing market patent protection and RDP for pharmaceuticals vary from country to country. The following summarizes key exclusivity rules in markets representing significant sales: United States In the U.S., most of our key products are protected by patents with varying terms depending on the type of patent and the filing date.
Specific aspects of the law governing market patent protection and regulatory exclusivity for pharmaceuticals vary from country to country. The following summarizes key exclusivity rules in markets representing significant sales: United States In the U.S., most of our key products are protected by patents with varying terms depending on the type of patent and the filing date.
The DSAs, including those with our three largest wholesalers, expire in June 2024 subject to certain termination provisions. Our non-U.S. businesses have significantly more direct customers. Information on available direct customer product level inventory and corresponding out-movement information and the reliability of third-party demand information varies widely.
The DSAs, including those with our three largest wholesalers, expire in June 2027 subject to certain termination provisions. Our non-U.S. businesses have significantly more direct customers. Information on available direct customer product level inventory and corresponding out-movement information and the reliability of third-party demand information varies widely.
Drugs that are more complex to manufacture (e.g., sterile injectable products) usually experience a slower decline than those that are simpler to manufacture. 14 In certain countries outside the U.S., patent protection is weak or nonexistent and we are challenged by generic versions shortly after we launch our innovative products.
Drugs that are more complex to manufacture (e.g., sterile injectable products) usually experience a slower decline than those that are simpler to manufacture. 15 In certain countries outside the U.S., patent protection is weak or nonexistent and we are challenged by generic versions shortly after we launch our innovative products.
For example, we manufacture for clinical and commercial use several sterile products, biologic products and CAR-T products, all of which are particularly complex and involve highly specialized manufacturing technologies. As a result, even slight deviations at any point in their production process may lead to production failures or recalls.
For example, we manufacture for clinical and commercial use several sterile products, biologic products and CAR-T cell therapy products, all of which are particularly complex and involve highly specialized manufacturing technologies. As a result, even slight deviations at any point in their production process may lead to production failures or recalls.
In situations where there is only data exclusivity without patent protection, a competitor could seek regulatory approval by submitting its own clinical study data to obtain marketing approval prior to the expiration of RDP. We estimate the minimum market exclusivity date for each of our products for the purpose of business planning only.
In situations where there is only regulatory exclusivity without patent protection, a competitor could seek regulatory approval by submitting its own clinical study data to obtain marketing approval prior to the expiration of regulatory exclusivity. 6 We estimate the minimum market exclusivity date for each of our products for the purpose of business planning only.
Refer to the Summary of Abbreviated Terms at the end of this 2023 Form 10-K for definitions of capitalized terms used throughout the document. 1 Acquisitions, Divestitures, Licensing and Other Arrangements Acquisitions, divestitures, licensing and other arrangements allow us to focus our resources on growth opportunities that drive the greatest long-term value.
Refer to the Summary of Abbreviated Terms at the end of this 2024 Form 10-K for definitions of capitalized terms used throughout the document. 1 Acquisitions, Divestitures, Licensing and Other Arrangements Acquisitions, divestitures, licensing and other arrangements allow us to focus our resources on growth opportunities that drive the greatest long-term value.
Alliances” for further information on our most significant alliance agreements as well as other alliance agreements. Marketing, Distribution and Customers We promote the appropriate use of our products directly to healthcare professionals and organizations such as doctors, nurse practitioners, physician assistants, pharmacists, technologists, hospitals, PBMs and Managed Care Organizations ("MCOs").
Alliances” for further information on our most significant alliance agreements as well as other alliance agreements. Marketing, Distribution and Customers We promote the appropriate use of our products directly to healthcare professionals and organizations such as doctors, nurse practitioners, physician assistants, pharmacists, technologists, hospitals, PBMs and MCOs.
We also participate in federal government programs that specify discounts to certain federal government entities; the most significant of which are the U.S. Department of Defense and the U.S. Department of Veterans Affairs. These entities receive minimum discounts based off a defined “non-federal average manufacturer price” for purchases.
We also participate in federal government programs that specify discounts to certain federal government entities; the most significant of which are the U.S. Department of Defense and the U.S. Department of Veterans Affairs. These entities receive statutory discounts based off a defined “non-federal average manufacturer price” for purchases.
Currently, we are involved in investigation and remediation at 15 current or former facilities. We have also been identified as a PRP under applicable laws for environmental conditions at approximately 19 former waste disposal or reprocessing facilities operated by third parties at which investigation and/or remediation activities are ongoing.
Currently, we are involved in investigation and remediation at 15 current or former facilities. We have also been identified as a PRP under applicable laws for environmental conditions at approximately 20 former waste disposal or reprocessing facilities operated by third parties at which investigation and/or remediation activities are ongoing.
We are also subject to the jurisdiction of various other Federal and state regulatory and enforcement departments and agencies, such as the Federal Trade Commission, the Department of Justice and the Department of Health and Human Services in the U.S. We are also licensed by the U.S. Drug Enforcement Administration to procure and produce controlled substances.
We are also subject to the jurisdiction of various other Federal and state regulatory and enforcement departments and agencies, such as the Federal Trade Commission, the Department of Justice and the U.S. Department of Health and Human Services (the "HHS"). We are also licensed by the U.S. Drug Enforcement Administration to procure and produce controlled substances.
We have been generally, although not universally, successful in having our major products included on MCO and PBM formularies. 15 In many markets outside the U.S., we operate in an environment of government-mandated, cost-containment programs.
We have been generally, although not universally, successful in having our major products included on MCO and PBM formularies. 16 In many markets outside the U.S., we operate in an environment of government-mandated, cost-containment programs.
The following chart shows our key products together with the year in which the earliest basic exclusivity loss (patent rights or RDP exclusivity) is currently estimated to occur in the U.S., the EU and Japan (the “estimated minimum market exclusivity date”).
The following chart shows our key products together with the year in which the earliest basic exclusivity loss (patent rights or regulatory exclusivity) is currently estimated to occur in the U.S., the EU and Japan (the “estimated minimum market exclusivity date”).
The OIG has issued a series of guidances to segments of the healthcare industry, including the 2003 Compliance Program Guidance for Pharmaceutical Manufacturers, which includes a recommendation that pharmaceutical manufacturers, at a minimum, adhere to the PhRMA Code, a voluntary industry code of marketing practices.
The OIG has issued a series of guidelines to segments of the healthcare industry, including the 2003 Compliance Program Guidance for Pharmaceutical Manufacturers, which includes a recommendation that pharmaceutical manufacturers, at a minimum, adhere to the PhRMA Code, a voluntary industry code of marketing practices.
We also incur operating and capital costs for such matters on an ongoing basis, which were not material for 2023, 2022 and 2021. In addition, we invested in projects that reduce resource use of energy and water.
We also incur operating and capital costs for such matters on an ongoing basis, which were not material for 2024, 2023 and 2022. In addition, we invested in projects that reduce resource use of energy and water.
Our sales forces focus on communicating information about new approved products or uses, as well as approved uses of established products, and promotion to physicians is increasingly targeted at physician specialists who treat the patients in need of our medicines. 13 Our products are sold principally to wholesalers, specialty distributors, specialty pharmacies, and to a lesser extent, directly to distributors, retailers, hospitals, clinics and government agencies.
Our sales forces focus on communicating information about new approved products or uses, as well as approved uses of established products, and promotion to physicians is increasingly targeted at physician specialists who treat the patients in need of our medicines. 14 Our products are sold principally to contracted wholesalers, specialty distributors, specialty pharmacies, and to a lesser extent, retailers, hospitals, clinics and government agencies.
Acquired IPRD include upfront payments, contingent milestone payments in connection with asset acquisitions or in-license arrangements of third-party intellectual property rights, as well as any upfront and contingent milestones payable by BMS to alliance partners prior to regulatory approval. Our R&D expenses were $9.3 billion in 2023, $9.5 billion in 2022 and $10.2 billion in 2021.
Acquired IPRD include upfront payments, contingent milestone payments in connection with asset acquisitions or in-license arrangements of third-party intellectual property rights, as well as any upfront and contingent milestones payable by BMS to alliance partners prior to regulatory approval. Our R&D expenses were $11.2 billion in 2024, $9.3 billion in 2023 and $9.5 billion in 2022.
The pricing and reimbursement procedure can take months and sometimes years to complete. Throughout the EU, all products for which marketing authorizations have been filed after October and November 2005 are subject to an “8+2+1” RDP regime.
The pricing and reimbursement procedure can take months and sometimes years to complete. Throughout the EU, all products for which marketing authorizations have been filed after October and November 2005 are subject to an “8+2+1” regulatory exclusivity regime.
Recent LOE Products Revlimid ® Revlimid (lenalidomide) is an oral immunomodulatory drug that in combination with dexamethasone is indicated for the treatment of patients with multiple myeloma. Revlimid as a single agent is also indicated as a maintenance therapy in patients with multiple myeloma following autologous hematopoietic stem cell transplant.
Revlimid ® Revlimid (lenalidomide) is an oral immunomodulatory drug that in combination with dexamethasone is indicated for the treatment of patients with multiple myeloma. Revlimid as a single agent is also indicated as a maintenance therapy in patients with multiple myeloma following autologous hematopoietic stem cell transplant.
Revlimid and Pomalyst are distributed in the U.S. primarily through contracted pharmacies under the Lenalidomide Risk Evaluation and Mitigation Strategy ("REMS") ( Revlimid ) and Pomalyst REMS programs, respectively. These are proprietary, mandatory risk-management distribution programs tailored specifically to provide for the safe and appropriate distribution and use of Revlimid and Pomalyst .
Revlimid and Pomalyst are distributed in the U.S. primarily through contracted pharmacies under the Lenalidomide REMS ( Revlimid ) and Pomalyst REMS programs, respectively. These are proprietary, mandatory risk-management distribution programs tailored specifically to provide for the safe and appropriate distribution and use of Revlimid and Pomalyst .
In addition to our own manufacturing sites, we rely on third parties to manufacture or supply us with all or a portion of the active product ingredient or drug substance necessary for us to manufacture various products, including Eliquis, Opdivo , Pomalyst/Imnovid, Yervoy, Sprycel , Reblozyl, Abraxane, Zeposia, Camzyos, Sotyktu and Inrebic.
In addition to our own manufacturing sites, we rely on third parties to manufacture or supply us with all or a portion of the active product ingredient or drug substance necessary for us to manufacture various products, including Eliquis, Opdivo , Pomalyst/Imnovid, Yervoy, Sprycel , Reblozyl, Abraxane, Zeposia, Camzyos, Sotyktu, Augtyro, Krazati and Cobenfy.
Opdivo ® Opdivo (nivolumab) is a biological product and a fully human monoclonal antibody that binds to the PD-1 on T and NKT cells. It has been approved for several anti-cancer indications including bladder, blood, CRC, head and neck, RCC, HCC, lung, melanoma, MPM, stomach and esophageal cancer.
Alliances.” Growth Portfolio Opdivo ® Opdivo (nivolumab) is a biological product and a fully human monoclonal antibody that binds to the PD-1 on T and NKT cells. It has been approved for several anti-cancer indications including bladder, blood, CRC, head and neck, RCC, HCC, lung, melanoma, MPM, stomach and esophageal cancer.
Our People Strategy is designed to foster an inclusive and engaging work experience to attract, develop, and retain the most talented workforce which reflects the diverse cultures, backgrounds, and experiences of our patients and communities around the world.
People Strategy and Culture : Our People Strategy is designed to foster an inclusive and engaging work experience to attract, develop, and retain the most talented workforce that reflects the diverse cultures, backgrounds, and experiences of our patients and communities around the world.
The SEC allows us to disclose important information by referring to it in that manner. Please refer to such information. Our 2024 Proxy Statement will be available on our website under the “Investors—Financial Reporting—SEC Filings” caption within 120 days after the end of our fiscal year. 22
The SEC allows us to disclose important information by referring to it in that manner. Please refer to such information. Our 2025 Proxy Statement will be available on our website under the “Investors—Financial Reporting—SEC Filings” caption within 120 days after the end of our fiscal year. 23
Zeposia ® Zeposia (ozanimod) is an oral immunomodulatory drug used to treat relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults and to treat moderately to severely active UC in adults.
Zeposia ® Zeposia (ozanimod) is an oral immunomodulatory drug used to treat relapsing forms of MS, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults and to treat moderately to severely active UC in adults.
Federal government officials and legislators continue to face intense pressure from the public to manage the perceived high cost of pharmaceuticals and have responded by pursuing legislation, such as the Inflation Reduction Act of 2022 ("IRA") and other rules that claim to potentially further reduce the cost of drugs for the federal government and other stakeholders.
Federal government officials and legislators continue to face intense pressure from the public to manage the perceived high cost of pharmaceuticals and have responded by pursuing legislation, such as the IRA and other rules that claim to potentially further reduce the cost of drugs for the federal government and other stakeholders.
The information contained in or connected to our website is not deemed to be incorporated by reference in this 2023 Form 10-K or filed with the SEC. We incorporate by reference certain information from parts of our definitive proxy statement for our 2024 Annual Meeting of Shareholders (“2024 Proxy Statement”).
The information contained in or connected to our website is not deemed to be incorporated by reference in this 2024 Form 10-K or filed with the SEC. 22 We incorporate by reference certain information from parts of our definitive proxy statement for our 2025 Annual Meeting of Shareholders (“2025 Proxy Statement”).
The marketing practices of all U.S. pharmaceutical manufacturers are subject to Federal and state healthcare laws that are used to protect the integrity of government healthcare programs. The Office of Inspector General (“OIG”) oversees compliance with applicable Federal laws, in connection with the payment for products by government funded programs, primarily Medicaid and Medicare.
The marketing practices of all U.S. pharmaceutical manufacturers are subject to Federal and state healthcare laws that are used to protect the integrity of government healthcare programs. The OIG oversees compliance with applicable Federal laws, in connection with the payment for products by government funded programs, primarily Medicaid and Medicare.
Employee Health & Safety : We are committed to protecting our workforce, communities, and patients, thereby ensuring the continued supply of life-saving medicines. Our goal is to ensure that all employees, contractors, and visitors to our sites, can work or conduct their visit safely.
Employee Health & Safety : We are committed to protecting our workforce, communities, and patients, thereby ensuring the continued supply of life-saving medicines. We have comprehensive policies that ensure all employees, contractors, and visitors to our sites, can work or conduct their visit safely.
For example, in recent years the FDA Oncology Center of Excellence (“OCE”) established two projects to test novel approaches for more efficient regulatory review of oncology drugs: the Real-Time Oncology Review pilot program and the Assessment Aid.
For example, in recent years the FDA OCE established two projects to test novel approaches for more efficient regulatory review of oncology drugs: the Real-Time Oncology Review pilot program and the Assessment Aid.
In general, Japanese law treats chemically-synthesized and biologically-derived drugs the same with respect to intellectual property and market exclusivity. Rest of the World In countries outside of the U.S., the EU and Japan, there is a wide variety of legal systems with respect to intellectual property and market exclusivity of pharmaceuticals.
In general, Japanese law treats chemically synthesized and biologically derived drugs the same with respect to intellectual property and regulatory exclusivity. Rest of the World In countries outside of the U.S., the EU and Japan, there are a variety of legal systems with respect to intellectual property and regulatory exclusivity of pharmaceuticals.
For our cell therapy product candidates and marketed products, including Breyanzi and Abecma , we have invested in our own manufacturing network, including facilities in Bothell, Washington; Summit, New Jersey; Devens, Massachusetts; Leiden; the Netherlands; and Libertyville, Illinois; as well as the use of third-party manufacturers.
We continue to make capital investments in our Devens, Massachusetts manufacturing facility. For our cell therapy product candidates and marketed products, including Breyanzi and Abecma , we have invested in our own manufacturing network, including facilities in Bothell, Washington; Summit, New Jersey; Devens, Massachusetts; Libertyville, Illinois; and Leiden, the Netherlands; as well as the use of third-party manufacturers.
Orencia ® Orencia (abatacept) is a biological product, is a fusion protein indicated for adult patients with moderate to severe active RA and PsA and is also indicated for reducing signs and symptoms in certain pediatric patients with moderately to severely active polyarticular JIA and for the treatment of aGVHD, in combination with a calcineurin inhibitor and methotrexate.
Orencia ® Orencia (abatacept) is a biological product and a fusion protein indicated for adult patients with moderate to severe active RA and PsA. It has indications for (i) reducing signs and symptoms in certain pediatric patients with moderately to severely active polyarticular JIA and (ii) for the treatment of aGVHD, in combination with a calcineurin inhibitor and methotrexate.
(j) For Pomalyst in the U.S., we currently do not expect generic entry prior to the first quarter of 2026. For Europe, the estimated minimum market exclusivity date is August 2024 based on RDP exclusivity. For Japan, the estimated minimum market exclusivity date is 2026 based on a method of use patent.
(j) For Pomalyst in the U.S., we currently do not expect generic entry prior to the first quarter of 2026. In Europe, generics have entered the market. In Japan, the estimated minimum market exclusivity date is 2026 based on a method of use patent.
Biologics are typically administered to patients through injections or by intravenous infusion. CAR-T therapies are administered to patients by intravenous infusion. Below is a summary of our significant products, including approved indications. For information about our alliance arrangements for certain of the products below, refer to “—Alliances” below and “Item 8. Financial Statements and Supplementary Data—Note 3.
CAR-T cell therapies are administered by intravenous infusion. Below is a summary of our significant products, including approved indications. For information about our alliance arrangements for certain of the products below, refer to “—Alliances” below and “Item 8. Financial Statements and Supplementary Data—Note 3.
Our focus as a biopharmaceutical company is on discovering, developing and delivering transformational medicines for patients facing serious diseases in areas where we believe that we have an opportunity to make a meaningful difference: oncology, hematology, immunology, cardiovascular and neuroscience.
Our focus as a biopharmaceutical company is on discovering, developing and delivering transformational medicines for patients facing serious diseases in areas where we believe that we have an opportunity to make a meaningful difference: oncology, hematology, immunology, cardiovascular, neuroscience and other areas where we can also deliver attractive returns for shareholders.
Phase II clinical studies involve a larger patient population to investigate side effects, efficacy and optimal dosage of the drug candidate. Phase III clinical studies are conducted to confirm Phase II results in a significantly larger patient population over a longer term and to provide reliable and conclusive data regarding the safety and efficacy of a drug candidate.
Phase III clinical studies are conducted to confirm Phase II results in a significantly larger patient population over a longer term and to provide reliable and conclusive data regarding the safety and efficacy of a drug candidate.
Pomalyst/Imnovid is indicated for patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy. Yervoy ® Yervoy (ipilimumab) is a biological product and is a CTLA4 immune checkpoint inhibitor.
Pomalyst/Imnovid is indicated for patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy.
As a result, our products may face restricted access, higher out of pocket expenses for patients, and pricing pressures by both public and private payers and may be subject to assessments of comparative value and effectiveness against existing standard of care.
As a result, our products may face restricted access and pricing pressures by both public and private payers and may be subject to assessments of comparative value and effectiveness against existing standard of care.
EU (p) Japan Abecma (idecabtagene vicleucel) 2036 2035 2035 Abraxane (paclitaxel) (a) ^^ ^^ ^^ Augtyro (repotrectinib) (b) 2035 ++ ++ Breyanzi (lisocabtagene maraleucel) (c) 2033 2033 2033 Camzyos (mavacamten) (d) 2034 2034 ++ Eliquis (apixaban) (e) 2026 ^^ 2026 Inrebic (fedratinib) (f) 2031 2031 ++ Onureg (azacitidine) (g) 2027 ^^ ++ Opdivo (nivolumab) 2028 2030 2031 Opdualag (nivolumab and relatlimab-rmbw) (h) 2034 2033 ++ Orencia (abatacept) (i) ^^ ^^ ^^ Pomalyst/Imnovid (pomalidomide) (j) ^^ 2024 ^^ Reblozyl (luspatercept-aamt) (k) 2031 2030 ++ Revlimid (lenalidomide) (l) ^^ ^^ ^^ Sotyktu (deucravacitinib) (m) 2033 2033 2033 Sprycel (dasatinib) (n) ^^ ^^ ^^ Yervoy (ipilimumab) 2025 2026 2025 Zeposia (ozanimod) (o) 2029 2034 ++ 6 ^^ See product footnote for more information. ++ We do not currently market the product in the country or region indicated.
EU (p) Japan Abecma (idecabtagene vicleucel) 2036 2035 2037 Abraxane (paclitaxel) (a) ^^ ^^ ^^ Augtyro (repotrectinib) (b) 2035 ++ ++ Breyanzi (lisocabtagene maraleucel) (c) 2033 2033 2033 Camzyos (mavacamten) (d) 2034 2034 ++ Cobenfy (xanomeline and trospium chloride) (e) ^^ ++ ++ Eliquis (apixaban) (f) 2028 ^^ 2026 Krazati (adagrasib) 2037 2038 ++ Opdivo (nivolumab) 2028 2030 2031 Opdivo Qvantig (nivolumab and hyaluronidase-nvhy) (g) ^^ ++ ++ Opdualag (nivolumab and relatlimab-rmbw) (h) 2034 2033 ++ Orencia (abatacept) (i) ^^ ^^ ^^ Pomalyst/Imnovid (pomalidomide) (j) ^^ ^^ ^^ Reblozyl (luspatercept-aamt) (k) 2031 2030 ++ Revlimid (lenalidomide) (l) ^^ ^^ ^^ Sotyktu (deucravacitinib) (m) 2033 2033 2033 Sprycel (dasatinib) (n) ^^ ^^ ^^ Yervoy (ipilimumab) 2025 2026 2025 Zeposia (ozanimod) (o) 2029 2034 ++ ^^ See product footnote for more information. ++ We do not currently market the product in the country or region indicated.
Alliances.” In-Line Products Eliquis ® Eliquis (apixaban) is an oral Factor Xa inhibitor indicated for the reduction in risk of stroke/systemic embolism in NVAF and for the treatment of DVT/PE and reduction in risk of recurrence following initial therapy.
Legacy Portfolio Eliquis ® Eliquis (apixaban) is an oral Factor Xa inhibitor indicated for the reduction in risk of stroke/systemic embolism in NVAF and for the treatment of DVT/PE and reduction in risk of recurrence following initial therapy.
Yervoy is a monoclonal antibody for the treatment of patients with unresectable or metastatic melanoma. The Opdivo + Yervoy regimen is approved in multiple markets for the treatment of NSCLC, melanoma, MPM, RCC, CRC and esophageal cancer.
Yervoy ® Yervoy (ipilimumab) is a biological product and is a CTLA4 immune checkpoint inhibitor. Yervoy is a monoclonal antibody for the treatment of patients with unresectable or metastatic melanoma. The Opdivo + Yervoy regimen is approved in multiple markets for the treatment of NSCLC, melanoma, MPM, RCC, CRC and esophageal cancer.
In order to address production constraints for CAR-T cell therapy manufacturing, we continue to partner with third party manufacturers to expand supply of vector and are investing in new facilities for drug product manufacturing. Longer-term, we are accelerating our plans to transition to new vector technologies with a dual sourcing strategy.
In order to support supply continuity, we continue to partner with third party manufacturers to expand supply of vector and are investing in new facilities for drug product manufacturing. Longer-term, we are accelerating our plans to transition to new vector technologies with a dual sourcing strategy.
A company seeking to market an innovative pharmaceutical in the U.S. must submit a complete set of safety and efficacy data to the FDA. If the innovative pharmaceutical is a chemical product, the company files an NDA. If the medicine is a biological product, a BLA is filed. Both types of applications can receive certain periods of regulatory exclusivity.
A company seeking to market an innovative pharmaceutical in the U.S. must submit a complete set of safety and efficacy data to the FDA. If the innovative pharmaceutical is a chemical product, the company files an NDA. If the medicine is a biological product, a BLA is filed.
(b) For Augtyro in the U.S., a PTR application is pending and, if granted, the estimated patent expiry will be 2037. (c) For Breyanzi in the U.S., a PTR application is pending and, if granted, the estimated patent expiry will be 2034.
(a) For Abraxane in the U.S., EU, and Japan, generics have entered the market. (b) For Augtyro in the U.S., a PTR application is pending and, if granted, the estimated patent expiry will be 2037. (c) For Breyanzi in the U.S., a PTR application is pending and, if granted, the estimated patent expiry will be 2034.
For example, on August 16, 2022, President Biden signed the Inflation Reduction Act of 2022 (“IRA”) into law which provides for (i) the government to set or “negotiate” prices for select high-cost Medicare Part D (beginning in 2026) and Medicare Part B drugs (beginning in 2028) that are more than nine years (for small-molecule drugs) or 13 years (for biological products) from their initial FDA approval, (ii) manufacturers to pay a rebate for Medicare Part B and Part D drugs when prices increase faster than inflation beginning in 2022 for Medicare Part D and 2023 for Medicare Part B drugs, and (iii) Medicare Part D redesign which replaces the current Part D Coverage Gap Discount Program (“CGDP”) and establishes a $2,000 cap for out-of-pocket limits costs for Medicare beneficiaries beginning in 2025, with manufacturers being responsible for 10% of costs up to the $2,000 cap and 20% after that cap is reached.
For example, on August 16, 2022, President Biden signed the IRA into law which provides for (i) the federal government to “negotiate” prices for select high-cost Medicare Part D (beginning in 2026) and Part B (beginning in 2028) drugs that are more than nine years (for small-molecule drugs) or 13 years (for biological products) from their initial FDA approval, (ii) manufacturers to pay a rebate for Medicare Part B and Part D drugs when prices increase faster than inflation, and (iii) the formation of the Part D Manufacturer Program which replaced the Part D CGDP and established a $2,000 cap for out-of-pocket costs for Medicare beneficiaries as of January 2025, with manufacturers being responsible for 10% of costs up to the $2,000 cap and 20% after that cap is reached.
Alliances may be structured as co-development, co-commercialization, licensing or joint venture arrangements. These arrangements may include upfront payments; option payments to develop or commercialize a specific asset or technology; payments for various developmental, regulatory and sales-based performance milestones; royalties; cost reimbursements; profit sharing; and equity investments.
These arrangements may include upfront payments; option payments to develop or commercialize a specific asset or technology; payments for various developmental, regulatory and sales-based performance milestones; royalties; cost reimbursements; profit sharing; and equity investments.
In the EU, SPC applications are pending and, if granted, the estimated patent expiry will be 2037. (i) BMS is not aware of an Orencia biosimilar on the market in the U.S., EU or Japan. Formulation and additional patents expire in 2026 and beyond.
In France, Italy and Spain, SPC and PED are granted and the estimated patent expiry is 2038. (i) BMS is not aware of an Orencia biosimilar on the market in the U.S., EU or Japan. Formulation and additional patents expire in 2026 and beyond.
The innovator then must decide whether to file a patent infringement suit against the generic manufacturer. From time to time, ANDAs including Paragraph IV certifications are filed with respect to certain of our products.
The innovator then must decide whether to file a patent infringement suit against the generic manufacturer. From time to time, ANDAs including Paragraph IV certifications are filed with respect to certain of our products. We evaluate these ANDAs on a case-by-case basis and, where warranted, file suit against the generic manufacturer to protect our patent rights.
(k) For Reblozyl in the U.S. and Europe, the estimated minimum market exclusivity date is based on RDP exclusivity. In the U.S., a PTR application on a method of treatment patent is pending and if granted, the estimated patent expiry will be 2033.
(k) For Reblozyl in the U.S. and Europe, the estimated minimum market exclusivity date is based on regulatory exclusivity. In the U.S., PTR on a method of treatment patent was granted, and the estimated patent expiry is 2033. In the EU, SPC on a method of treatment patent is granted, and the estimated patent expiry is 2034.
Our marketed biologic products include Opdivo , Orencia, Yervoy , Reblozyl, Abecma, Opdualag and Breyanzi. The increased likelihood of generic and biosimilar challenges to innovators’ intellectual property has increased the risk of loss of innovators’ market exclusivity. First, generic companies have increasingly sought to challenge innovators’ basic patents covering major pharmaceutical products.
The increased likelihood of generic and biosimilar challenges to innovators’ intellectual property has increased the risk of loss of innovators’ market exclusivity. First, generic companies have increasingly sought to challenge innovators’ patents covering major pharmaceutical products.
Camzyos ® Camzyos (mavacamten) is a cardiac myosin inhibitor indicated for the treatment of adults with symptomatic obstructive HCM to improve functional capacity and symptoms. Sotyktu ® Sotyktu (deucravacitinib) is an oral, selective, allosteric tyrosine kinase 2 inhibitor indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
Sotyktu ® Sotyktu (deucravacitinib) is an oral, selective, allosteric tyrosine kinase 2 inhibitor indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
The clinical development of a potential new drug typically includes Phase I, Phase II and Phase III clinical studies that have been designed specifically to support an application for regulatory approval for a particular indication, assuming the studies are successful. 7 Phase I clinical studies involve a small number of healthy volunteers or patients suffering from the indicated disease to test for safety and proper dosing.
The clinical development of a potential new drug typically includes Phase I, Phase II and Phase III clinical studies that have been designed specifically to support an application for regulatory approval for a particular indication, assuming the studies are successful.
In addition, in support of a continued investment in our cell therapy portfolio, we continue expanding our manufacturing capabilities through the construction of new state-of-the-art cell therapy manufacturing facilities in Devens, Massachusetts, which was completed in 2023, as well as Leiden, Netherlands and Libertyville, Illinois which are currently ongoing.
In addition, in support of a continued investment in our cell therapy portfolio, we continue expanding our manufacturing capabilities through the construction of new state-of-the-art cell therapy manufacturing facilities in Devens, Massachusetts, which was completed in 2023, as well as in Leiden, Netherlands and Libertyville, Illinois which are currently ongoing. 8 We supplement our internal drug discovery and development programs with acquisitions, alliances and collaborative agreements which help us bring new molecular agents, capabilities and platforms into our pipeline.
Quality assurance groups routinely monitor manufacturing procedures and systems used by us, our subsidiaries and third-party suppliers to help ensure quality and compliance requirements are met. 19 Environmental Regulation Our facilities and operations are subject to extensive U.S. and foreign laws and regulations relating to environmental protection and human health and safety, including those governing discharges of pollutants into the air and water; the use, management and disposal of hazardous, radioactive and biological materials and wastes; and the cleanup of contamination.
Environmental Regulation Our facilities and operations are subject to extensive U.S. and foreign laws and regulations relating to environmental protection and human health and safety, including those governing discharges of pollutants into the air and water; the use, management and disposal of hazardous, radioactive and biological materials and wastes; and the cleanup of contamination.
Protection for individual products extends for varying periods in accordance with the expiration dates of patents in the various countries. The protection afforded, which may also vary from country to country, depends upon the type of patent, its scope of coverage and the availability of meaningful legal remedies in the country.
The protection afforded, which may also vary from country to country, depends upon the type of patent, its scope of coverage and the availability of meaningful legal remedies in the country.
By encouraging employees around the world—across diverse cultures, backgrounds and experiences—to be their authentic selves at work, to speak up and think boldly, we create an energized environment of co-collaboration and co-design where bold ideas and solutions can lead to improved patient outcomes. Our patients, communities, colleagues and industry deserve nothing less.
By encouraging employees around the world to be their authentic selves at work, to ask questions, voice concerns, and think boldly, we create an energized environment of co-collaboration and co-design where bold ideas and solutions can lead to improved patient outcomes.
Market exclusivity is also sometimes provided by RDP, a period of time after the approval of a new drug during which the regulatory agency may not rely upon the innovator’s data to approve a competitor’s generic copy. Many developed countries provide certain non-patent incentives for the development of medicines.
Market exclusivity is also sometimes provided by regulatory exclusivity, a period of time after the approval of a new drug during which the regulatory agency may not rely upon the innovator’s data to approve a competitor’s generic or biosimilar copy. Regulatory exclusivity can provide a market exclusivity period on a product that expires beyond the patent term.
We attempt, if possible, to mitigate our potential risk associated with our raw materials, components and supplies through inventory management and alternative sourcing strategies.
We attempt, if possible, to mitigate our potential risk associated with our raw materials, components and supplies through inventory management and alternative sourcing strategies. For further discussion of sourcing, refer to “—Manufacturing and Quality Assurance” below and discussions of particular products.
Pharmaceutical manufacturing processes are complex, highly regulated and vary widely from product to product. Given that shifting or adding manufacturing capacity can be a lengthy process requiring significant capital and other expenditures as well as regulatory approvals, we manage and operate a flexible manufacturing network that minimizes unnecessary product transfers and inefficient uses of manufacturing capacity.
Given that shifting or adding manufacturing capacity can be a lengthy process requiring significant capital and other expenditures as well as regulatory approvals, we manage and operate a flexible manufacturing network that minimizes unnecessary product transfers and inefficient uses of manufacturing capacity. For further discussion of the regulatory impact on our manufacturing, refer to “—Government Regulation” above.
We own or license a number of patents in the U.S. and foreign countries primarily covering our products. We have also developed many brand names and trademarks for our products.
We own or license a number of patents in the U.S. and foreign countries primarily covering our products. We have also developed many brand names and trademarks for our products. We consider the overall protection of our patents, trademarks, licenses and other intellectual property rights to be of material value and act to protect these rights from infringement.
Our pipeline was built by coupling internal research and development programs with a distributed research and development model, which focused on identifying and supporting the development of disruptive and innovative therapies outside the company through a broad network of external partnerships. Management continues to emphasize leadership, innovation, productivity and quality as strategies for success in our R&D activities.
We have a broad pipeline with over 40 unique assets in development. Our pipeline was built by coupling internal research and development programs with a distributed research and development model, which focused on identifying and supporting the development of disruptive and innovative therapies outside the company through a broad network of external partnerships.
We also sell our pharmaceutical products in other countries; however, data is not provided on a country-by-country basis because individual country revenues are not significant outside the U.S., the EU and Japan. Generally, the estimated minimum market exclusivity date in the table below pertains to the end of RDP, COM patent expiration for the respective products and PTR if granted.
We also sell our pharmaceutical products in other countries; however, data is not provided on a country-by-country basis because individual country revenues are not significant outside the U.S., the EU and Japan.
Pomalyst ® /Imnovid ® Pomalyst/Imnovid (pomalidomide) is a small molecule that is administered orally and modulates the immune system and other biologically important targets.
Revlimid has received approvals for several indications in the hematological malignancies including lymphoma and MDS. Pomalyst ® /Imnovid ® Pomalyst/Imnovid (pomalidomide) is a small molecule that is administered orally and modulates the immune system and other biologically important targets.
Legal Proceedings and Contingencies.” Human Capital Management and Resources We believe that our employees around the world embody our mission to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. Together, their unyielding focus on patients defines our culture. Demographics: As of December 31, 2023, we had approximately 34,100 employees in 43 countries.
Legal Proceedings and Contingencies.” Human Capital Management and Resources We believe that our employees around the world are compassionate, purpose-driven professionals who embody our mission of discovering and delivering innovative medicines that help patients prevail over serious diseases. Together, their unyielding focus on patients defines our culture.
Natco and certain other generics have begun marketing generic lenalidomide products in the U.S. pursuant to those volume-limited licenses. In addition, Natco and other generic companies have been granted licenses to sell generic lenalidomide in the U.S. without volume limitation beginning on January 31, 2026. In the EU and Japan generics have entered the market.
(l) For Revlimid, in the U.S., certain generic companies have begun marketing generic lenalidomide products pursuant to volume-limited licenses granted as part of litigation settlements. The licenses will no longer be volume-limited beginning on January 31, 2026. In the EU and Japan, generics have entered the market.
Sprycel ® Sprycel (dasatinib) is an oral inhibitor of multiple tyrosine kinase indicated for the first-line treatment of patients with Philadelphia chromosome-positive CML in chronic phase and the treatment of adults with chronic, accelerated, or myeloid or lymphoid blast phase CML with resistance or intolerance to prior therapy, including Gleevec* (imatinib mesylate) and the treatment of children and adolescents aged 1 year to 18 years with chronic phase Philadelphia chromosome-positive CML. 2 New Product Portfolio Reblozyl ® Reblozyl (luspatercept-aamt) is a biological product, and is an erythroid maturation agent indicated for the treatment of anemia in i) adult patients with transfusion dependent and non-transfusion dependent beta thalassemia who require regular red blood cell transfusions, ii) adult patients with very low- to intermediate-risk MDS who have ring sideroblasts and require red blood cell transfusions, as well as iii) adult patients without previous erythropoiesis stimulating agent use (ESA-naïve) with very low- to intermediate-risk MDS who may require regular red blood cell transfusions, regardless of ring sideroblast status.
Reblozyl ® Reblozyl (luspatercept-aamt) is a biological product, and is an erythroid maturation agent indicated for the treatment of anemia in (i) adult patients with transfusion dependent and non-transfusion dependent beta thalassemia who require regular red blood cell transfusions, (ii) adult patients with very low- to intermediate-risk MDS who have ring sideroblasts and require red blood cell transfusions, as well as (iii) adult patients without previous erythropoiesis stimulating agent use (ESA-naïve) with very low- to intermediate-risk MDS who may require regular red blood cell transfusions, regardless of RS status.
Management's Discussion and Analysis of Financial Condition and Results of Operations—Strategy.” We compete with other worldwide research-based drug companies, smaller research companies and generic drug manufacturers. Our products are sold worldwide, primarily to wholesalers, distributors, specialty pharmacies, and to a lesser extent, directly to retailers, hospitals, clinics and government agencies.
We compete with other global research-based biopharmaceutical companies, smaller research companies and generic drug manufacturers. Our products are sold worldwide, primarily to wholesalers, distributors, specialty pharmacies, and to a lesser extent, directly to retailers, hospitals, clinics and government agencies. We have significant manufacturing operations in the U.S., Puerto Rico, Switzerland, Ireland, and the Netherlands.
Patents provide the innovator with the right to exclude others from practicing an invention related to the medicine. Patents may cover, among other things, the active ingredient(s), various uses of a drug product, pharmaceutical formulations, drug delivery mechanisms and processes for (or intermediates useful in) the manufacture of products.
Patents may cover, among other things, the active ingredient(s), various uses of a drug product, pharmaceutical formulations, drug delivery mechanisms and processes for (or intermediates useful in) the manufacture of products. Protection for individual products extends for varying periods in accordance with the expiration dates of patents in the various countries.
In August 2023, the U.S. Department of Health and Human Services selected Eliquis as one of the first 10 medicines subject to government-set prices beginning in 2026. It is possible that more of our products could be selected in future years, which could, among other things, accelerate revenue erosion prior to expiry of intellectual property protections.
In January 2025, the HHS selected Pomalyst as a medicine subject to "negotiation" for government-set prices beginning in 2027. It is possible that more of our products could be selected in future years, which could, among other things, accelerate revenue erosion prior to expiry of intellectual property protections.
However, if enacted, these changes could modify or decrease access, coverage, or reimbursement of our products, impact our rebates, or shift costs to us, which could in turn have a material impact on our business and results of operations.
However, such measures could modify or decrease access, coverage, or reimbursement of our products, or result in significant changes to our sales or pricing practices, which could have a material impact on our revenues and results of operations.
For further discussion of the regulatory impact on our manufacturing, refer to “—Government Regulation” above. Our significant biologics, cell therapy and pharmaceutical manufacturing facilities are located in the U.S., Puerto Rico, Ireland and Switzerland and require significant ongoing capital investment for both maintenance and compliance with increasing regulatory requirements.
Our significant biologics, cell therapy and pharmaceutical manufacturing facilities are located in the U.S., Puerto Rico, the Netherlands, Ireland and Switzerland and require significant ongoing capital investment for both maintenance and compliance with increasing regulatory requirements. For example, the FDA approved our Devens, Massachusetts commercial facility for CAR-T cell therapy manufacturing in June 2023.
Products, Intellectual Property and Product Exclusivity Our pharmaceutical products include chemically-synthesized or small molecule drugs, products produced from biological processes, called “biologics” and chimeric antigen receptor (CAR-T) cell therapies. Small molecule drugs are typically administered orally in the form of a tablet or capsule, although other drug delivery mechanisms are used as well.
Our platforms are comprised of chemically-synthesized or small molecule drugs including protein degraders; drugs produced from biological processes, called “biologics”; ADCs, CAR-T cell therapies, and radiopharmaceutical therapeutics. Small molecule drugs are typically administered orally in the form of a tablet or capsule, although other drug delivery mechanisms are also used. Biologics are typically administered through injections or by intravenous infusion.
We operate in one segment engaged in the discovery, development, licensing, manufacturing, marketing, distribution and sale of biopharmaceutical products on a global basis.
We operate in one segment engaged in the discovery, development, licensing, manufacturing, marketing, distribution and sale of biopharmaceutical products on a global basis. Our principal strategy is to combine the resources, scale and capability of a pharmaceutical company with the speed and focus on innovation of the biotech industry.

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

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Biggest changeSome of the difficulties, delays and disruptions include: (i) product seizures or recalls or forced closings of manufacturing plants; (ii) our failure, or the failure of any of our vendors or suppliers, to comply with cGMP and other applicable regulations or quality assurance guidelines that could lead to manufacturing shutdowns, product shortages or delays in product manufacturing; (iii) manufacturing, quality assurance/quality control, supply problems or governmental approval delays; (iv) the failure of a supplier, including sole source or single source suppliers, to provide us with the necessary raw materials, supplies or finished goods within a reasonable timeframe and with required quality; (v) the failure of a third-party manufacturer to supply us with bulk active or finished product on time; (vi) construction or regulatory approval delays for new facilities or the expansion of existing facilities, including those intended to support future demand for our biologics products, such as Opdivo; (vii) the failure to meet new and emerging regulations requiring products to be tracked throughout the distribution channels using unique identifiers to verify their authenticity in the supply chain; (viii) other manufacturing or distribution issues, including limits to manufacturing capacity and changes in the types of products produced, such as biologics, physical limitations, labor disputes or shortages, or other business interruptions; and (ix) disruptions in supply chain continuity, including from market forces (such as the recent stress on global logistics), natural disasters, global disease outbreaks or pandemics (including COVID-19), acts of war or terrorism or other unforeseeable or unavoidable events that materially impact one or more of our facilities or a critical supplier.
Biggest changeSome of the difficulties, delays and disruptions include: (i) product seizures or recalls or forced closings of manufacturing plants; (ii) our failure, or the failure of any of our vendors or suppliers, to comply with cGMP and other applicable regulations or quality assurance guidelines that could lead to manufacturing shutdowns, product shortages or delays in product manufacturing; (iii) manufacturing, quality assurance/quality control, supply problems or governmental approval delays; (iv) the failure of a supplier, including sole source or single source suppliers, to provide us with the necessary raw materials, supplies or finished goods within a reasonable timeframe and with required quality; (v) the failure of a third-party manufacturer to supply us with bulk active or finished product on time; (vi) construction or regulatory approval delays for new facilities or the expansion of existing facilities, including those intended to support future demand for our biologics products; (vii) the failure to meet new and emerging regulations requiring products to be tracked throughout the distribution channels using unique identifiers to verify their authenticity in the supply chain; (viii) other manufacturing or distribution issues, including limits to manufacturing capacity and changes in the types of products produced, such as biologics, physical limitations, labor disputes or shortages, or other business interruptions; (ix) geopolitical factors in a specific country or region, including any new, or changes in or interpretations of existing, trade regulations, including for example, any new tariffs imposed in the jurisdictions in which we operate, or compliance requirements of other legislation; and (x) disruptions in supply chain continuity, including from market forces, natural disasters, global disease outbreaks or pandemics (including COVID-19), acts of war or terrorism or other unforeseeable or unavoidable events that materially impact one or more of our facilities or a critical supplier. 27 In addition, manufacturing processes for novel cell-based therapies, such as CAR-T cell therapies, are still evolving, and our processes may be more complicated or more expensive than the approaches taken by our current and future competitors.
Foreign Corrupt Practices Act or UK Bribery Act, including compliance with ongoing reporting obligations to the government resulting from any settlements; (iv) recalls or withdrawals of pharmaceutical products or forced closings of manufacturing plants; (v) the alleged failure to fulfill obligations under supply contracts with the government and other customers or under other agreements relating to our business; (vi) product pricing and promotional matters; (vii) lawsuits and claims asserting, or investigations into, violations of securities, antitrust, Federal and state pricing, consumer protection, data privacy and other laws and regulations; (viii) environmental, health, safety and sustainability matters, including regulatory actions in response to climate change; and (ix) tax liabilities resulting from assessments from tax authorities.
Foreign Corrupt Practices Act or the UK Bribery Act, including compliance with ongoing reporting obligations to the government resulting from any settlements; (iv) recalls or withdrawals of pharmaceutical products or forced closings of manufacturing plants; (v) the alleged failure to fulfill obligations under supply contracts with the government and other customers or under other agreements relating to our business; (vi) product pricing and promotional matters; (vii) lawsuits and claims asserting, or investigations into, violations of securities, antitrust, Federal and state pricing, consumer protection, data privacy and other laws and regulations; (viii) environmental, health, safety and sustainability matters, including regulatory actions in response to climate change; and (ix) tax liabilities resulting from assessments from tax authorities.
The failure of any critical third party to satisfactorily meet its obligations, including for future royalty and milestone payments; to adequately deploy business continuity plans in the event of a crisis; and/or to satisfactorily resolve significant disagreements with us or address other factors, could have a material adverse impact on our operations and results.
The failure of any critical third party to satisfactorily meet its obligations, including for future royalty and milestone payments; to adequately deploy business continuity plans in the event of a crisis; and/or to satisfactorily resolve significant disagreements with us or address other factors, could have a material adverse impact on our business and results of operations.
Our amended bylaws provide that, unless we consent in writing to the selection of an alternative forum, the Court of Chancery of the State of Delaware will be, to the fullest extent permitted by law, the sole and exclusive forum for any (i) derivative action or proceeding brought on our behalf, (ii) action asserting a claim of breach of a fiduciary duty owed by any of our directors, officers or other employees to us or our stockholders, creditors or other constituents, (iii) action asserting a claim arising pursuant to any provision of the General Corporation Law of the State of Delaware, our amended and restated certificate of incorporation or our amended bylaws or (iv) action asserting a claim against us or any of our directors, officers or other employees governed by the internal affairs doctrine; provided, however, that, in the event that the Court of Chancery of the State of Delaware lacks jurisdiction over any such action or proceeding, the sole and exclusive forum for such action or proceeding will be another state or federal court of the State of Delaware.
Our amended bylaws provide that, unless we consent in writing to the selection of an alternative forum, the Court of Chancery of the State of Delaware will be, to the fullest extent permitted by law, the sole and exclusive forum for any (i) derivative action or proceeding brought on our behalf, (ii) action asserting a claim of breach of a fiduciary duty owed by any of our directors, officers or other employees to us or our stockholders, creditors or other constituents, (iii) action asserting a claim arising pursuant to any 33 provision of the General Corporation Law of the State of Delaware, our amended and restated certificate of incorporation or our amended bylaws or (iv) action asserting a claim against us or any of our directors, officers or other employees governed by the internal affairs doctrine; provided, however, that, in the event that the Court of Chancery of the State of Delaware lacks jurisdiction over any such action or proceeding, the sole and exclusive forum for such action or proceeding will be another state or federal court of the State of Delaware.
These laws and regulations control and regulate key aspects of our business including but not limited to (i) market access, pricing controls and discounting; (ii) tax liabilities, returns and payments; (iii) imports and other trade restrictions; (iv) intellectual property protection and enforcement; (v) good practice guidelines and regulations; (vi) accounting standards; (vii) data storage and privacy, particularly in the EU and the U.S.; (viii) requirements for reporting payments and other value transfers to healthcare professionals (such as those provided under the Federal Anti-Kickback Statute); and (ix) compliance with anti-bribery and anti-corruption practices of the U.S. and other countries.
These laws and regulations control and regulate key aspects of our business, including, but not limited to: (i) market access, pricing controls and discounting; (ii) tax liabilities, returns and payments; (iii) imports and other trade restrictions; (iv) intellectual property protection and enforcement; (v) good practice guidelines and regulations; (vi) accounting standards; (vii) cybersecurity and data protection, storage and privacy, particularly in the EU and the U.S.; (viii) requirements for reporting payments and other value transfers to healthcare professionals (such as those provided under the Federal Anti-Kickback Statute); and (ix) compliance with anti-bribery and anti-corruption practices of the U.S. and other countries.
Developing and commercializing new compounds and products involve inherent risks and uncertainties, including (i) efficacy and safety concerns or findings of superior safety or efficacy of competing products; (ii) delayed or denied regulatory approvals, including as a result of difficulties in enrolling patients and completing clinical trials in a timely manner; (iii) delays or challenges with producing products on a commercial scale or excessive costs to manufacture products; (iv) failure to enter into or implement optimal alliances for the development and/or commercialization of new products; (v) changes in regulatory approval processes and policies which may cause delays or denials of new product approvals; (vi) preclusion from commercialization due to intellectual property issues or disputes with third parties; (vii) failure in certain markets to obtain reimbursement commensurate with the level of innovation and clinical benefit presented by the product; and (viii) changing clinical preferences, changing industry standards, laws and regulations, or competitors’ innovations, each of which may render new products or enhancements to existing products obsolete.
Developing and commercializing new compounds and products involves inherent risks and uncertainties, including (i) efficacy and safety concerns or findings of superior safety or efficacy of competing products; (ii) delayed or denied regulatory approvals, including as a result of difficulties in enrolling patients and completing clinical trials in a timely manner; (iii) delays or challenges with producing products on a commercial scale or excessive costs to manufacture products; (iv) failure to enter into or implement optimal alliances for the development and/or commercialization of new products; (v) changes in regulatory approval processes and policies which may cause delays or denials of new product approvals; (vi) preclusion from commercialization due to intellectual property issues or disputes with third parties; (vii) failure in certain markets to obtain reimbursement commensurate with the level of innovation and clinical benefit presented by the product; and (viii) changing clinical preferences, changing industry standards, laws and regulations, or competitors’ innovations, each of which may render new products or enhancements to existing products obsolete.
If we are unable to consistently maintain an adequate pipeline, whether through internal R&D programs or transactions with third parties or if we are unable to support and grow our marketed products, successfully execute the launches of newly approved products, advance our late-stage pipeline, manage change from our operating model evolution or manage our costs effectively, our operating results and financial condition could be negatively impacted.
If we are unable to consistently maintain an adequate pipeline, whether through internal R&D programs or transactions with third parties or if we are unable to support and grow our marketed products, successfully execute the launches of newly approved products, advance our late- 31 stage pipeline, manage change from our operating model evolution or manage our costs effectively, our operating results and financial condition could be negatively impacted.
There is an increased focus by foreign, federal, state, and local regulatory and legislative bodies investors and other stakeholders regarding environmental policies relating to climate change, regulating greenhouse gas emissions, carbon taxes, emissions trading schemes, sustainability, human rights and diversity, inclusion and equity matters, and disclosure regarding the foregoing, many of which may be ambiguous, inconsistent, dynamic or conflicting.
There is an increased focus by foreign, federal, state, and local regulatory and legislative bodies investors and other stakeholders regarding environmental policies relating to climate change, regulating greenhouse gas emissions, carbon taxes, emissions trading schemes, sustainability, human rights, inclusion and diversity matters, and disclosure regarding the foregoing, many of which may be ambiguous, inconsistent, dynamic or conflicting.
If the development of any of our key late-stage product candidates is delayed or discontinued or a clinical study does 24 not meet one or more of its primary endpoints, our stock price could decline significantly and there may be an adverse impact on our business, financial condition or results of operations.
If the development of any of our key late-stage product candidates is delayed or discontinued or a clinical study does not meet one or more of its primary endpoints, our stock price could decline significantly and there may be an adverse impact on our business, financial condition or results of operations.
Although we are committed to reducing our debt, pursuing strategic transaction opportunities in future may require us to obtain additional equity or debt financing, and could result in increased leverage and/or a downgrade of our credit ratings. Failure to attract and retain highly qualified workforce could affect our ability to successfully develop and commercialize products.
Although we are committed to reducing our debt, pursuing strategic transaction opportunities in the future may require us to obtain additional equity or debt financing, and could result in increased leverage and/or a downgrade of our credit ratings. Failure to attract and retain a highly qualified workforce could affect our ability to successfully develop and commercialize products.
FDA have taken steps to promote the development and approval of generic drugs and biosimilar biologics, including by providing generic and biosimilar developers a private right of action to obtain sufficient quantities of drug samples from the reference product’s manufacturer in order to conduct testing necessary to obtain approval for generic or biosimilar products.
Congress and the FDA have taken steps to promote the development and approval of generic drugs and biosimilar biologics, including by providing generic and biosimilar developers a private right of action to obtain sufficient quantities of drug samples from the reference product’s manufacturer in order to conduct testing necessary to obtain approval for generic or biosimilar products.
In addition, some countries are allowing manufacturers to manufacture and sell generic products, which negatively impacts the protections afforded the Company. Lower-priced generics or biosimilars for BMS biologic products or competing biologics could negatively impact our volumes and prices. In addition, both the U.S. Congress and the U.S.
In addition, some countries are allowing manufacturers to manufacture and sell generic products, which negatively impacts the protections afforded the Company. Lower-priced generics or biosimilars for BMS biologic products or competing biologics could negatively impact our volumes and prices. In addition, both the U.S.
In addition, we may still be subject to penalties or potential litigation if such laws and regulations are interpreted or applied in a manner inconsistent with our practices. Moreover, from time to time we establish and publicly announce environmental, social and governance goals and commitments.
In addition, we may still be subject to penalties or potential litigation if such laws and regulations are interpreted or applied in a manner inconsistent with our practices. Moreover, from time to time we establish and publicly announce environmental, social and governance aspirational goals and commitments.
As the cyber-threat landscape evolves, these attacks are growing in frequency, sophistication and intensity, and due to the nature of some of these attacks, there is also a risk that they may remain undetected for a period of time.
As the cyber-threat landscape evolves, these attacks are growing in frequency, sophistication and intensity, and due 30 to the nature of some of these attacks, there is also a risk that they may remain undetected for a period of time.
We have faced, and will continue to face, risks of incidents, whether through cyber attacks or cyber intrusions through the Cloud, the Internet, phishing attempts, ransomware and other forms of malware, computer viruses, email attachments, extortion, and other scams.
We have faced, and will continue to face, risks of incidents, whether through cyber attacks or cyber intrusions through the Cloud, the Internet, phishing attempts, ransomware and other forms of malware, computer viruses, email attachments, extortion, exfiltration and other scams.
In addition, uncertainty in the credit and capital markets could impact our growth strategy. Our revenues, earnings and cash flow are also exposed to risk from a strengthening U.S. dollar and global inflation, including in the U.S.
In addition, uncertainty in the credit and capital 32 markets could impact our growth strategy. Our revenues, earnings and cash flow are also exposed to risk from a strengthening U.S. dollar and global inflation, including in the U.S.
Although we make efforts to maintain the security and integrity of our information technology systems, these systems and the proprietary, confidential and personal information that resides on or is transmitted through them, are subject to the risk of a cybersecurity incident or disruption, and there can be no assurance that our security efforts and measures, and those of our third-party vendors, will prevent breakdowns or incidents to our or our third-party vendors’ systems that could adversely affect our business strategy, results of operations, or financial condition.
Although we make efforts to maintain the security and integrity of our information technology systems and data, these systems and the proprietary, confidential and personal information that resides on or is transmitted through them, are subject to the risk of a cybersecurity incident or disruption, and there can be no assurance that our security efforts and measures, and those of our third-party vendors, will prevent breakdowns or incidents to our or our third-party vendors’ systems, which could adversely affect our business strategy, results of operations, or financial condition.
While we believe the risk of a court declining to enforce the forum selection provision contained in our amended bylaws is low, if a court were to find the provision inapplicable to, or unenforceable in respect of, one or more of the specified types of actions or proceedings, we may incur additional costs associated with resolving such action in other jurisdictions, which could harm our business, operating results and financial condition. 32 Item 1B.
While we believe the risk of a court declining to enforce the forum selection provision contained in our amended bylaws is low, if a court were to find the provision inapplicable to, or unenforceable in respect of, one or more of the specified types of actions or proceedings, we may incur additional costs associated with resolving such action in other jurisdictions, which could harm our business, operating results and financial condition. 34 Item 1B.
Our future revenues and profit margins could be negatively affected, including as a result of (i) changes in laws and regulations relating to the pricing and reimbursement of pharmaceutical products (including potential penalties for increasing prices over the rate of inflation, new discounts to fund a redesign of the Medicare Part D benefit, and government negotiations/price controls that may change the determination of the "best price" and establish a maximum allowed price/reimbursement rate), as well as other changes relating to federal healthcare programs, such as modifying the federal Anti-Kickback statute discount safe harbor and the IRA, which includes a number of provisions intended to lower the costs of some drugs covered under Medicare Part D and Medicare Part B and to limit Medicare beneficiaries’ out-of-pocket spending under the Medicare Part D benefit, (ii) cost-cutting measures by federal healthcare programs, such as Medicare and Medicaid, MCOs and other institutional and governmental purchasers, (iii) the grant of additional authority to governmental agencies to manage drug utilization and negotiate drug prices (including the implementation of the 2020 regulation issued by the U.S. federal government authorizing states and private parties to develop and implement programs to import certain prescription drugs from Canada and sell them in the U.S., and the American Rescue Plan Act of 2021, which eliminated the Medicaid Prescription Drug Rebate cap starting January 1, 2024), (iv) expanded utilization under the 340B Drug Pricing Program ("340B program"), (v) competition related to placements on applicable commercial and Medicare Part D formularies; (vi) changes to U.S. federal pharmaceutical coverage and reimbursement policies and practices, (vii) the increased scrutiny of drug manufacturers (including any additional review of BMS or Celgene by the House Oversight and Reform Committee), (viii) reimbursement delays, (ix) government price erosion mechanisms across Europe and in other countries resulting in deflation for pharmaceutical product pricing, (x) the increased purchasing power of entities that negotiate on behalf of Medicare, Medicaid and private sector beneficiaries, (xi) collection delays or failures to pay in government-funded public hospitals outside the U.S., (xii) developments in technology and/or industry practices that could impact the reimbursement policies and practices of third-party payers, and (xiii) inhibited market access due to real or perceived differences in value propositions for our products compared to competing products.
Our future revenues and profit margins could be negatively affected, including as a result of (i) changes in laws and regulations relating to the pricing and reimbursement of pharmaceutical products (including potential penalties for increasing prices over the rate of inflation and government negotiations/price controls that may change the determination of the "best price" and establish a maximum allowed price/reimbursement rate), as well as other changes relating to federal healthcare programs, such as modifying the federal Anti-Kickback statute discount safe harbor and the IRA, which includes a number of provisions intended to lower the costs of some drugs covered under Medicare Part D and Medicare Part B and to limit Medicare beneficiaries’ out-of-pocket spending under the Medicare Part D benefit, (ii) cost-cutting measures by federal healthcare programs, such as Medicare and Medicaid, MCOs and other institutional and governmental purchasers, (iii) the grant of additional authority to governmental agencies to manage drug utilization and negotiate drug prices (including the implementation of the 2020 regulation issued by the U.S. federal government authorizing states and private parties to develop and implement programs to import certain prescription drugs from Canada and sell them in the U.S., and the American Rescue Plan Act of 2021, which eliminated the Medicaid Prescription Drug Rebate cap as of January 1, 2024), (iv) expanded utilization and pharmaceutical company restrictions under the 340B Drug Pricing Program ("340B program"), (v) competition related to placements on applicable commercial and Medicare Part D formularies; (vi) changes to U.S. federal pharmaceutical coverage and reimbursement policies and practices, (vii) the increased purchasing power of entities that negotiate on behalf of Medicare, Medicaid and private sector beneficiaries, (viii) the increased scrutiny of drug manufacturers (including any additional review of BMS or Celgene by the House Oversight and Reform Committee), (ix) reimbursement delays, (x) government price erosion mechanisms across Europe, Japan and in other countries resulting in deflation for pharmaceutical product pricing, (xi) collection delays or failures to pay in government-funded public hospitals outside the U.S., (xii) developments in technology and/or industry practices that could impact the reimbursement policies and practices of third-party payers, and (xiii) inhibited market access due to real or perceived differences in value propositions for our products compared to competing products.
Additionally, manufacturers who are found to have knowingly and intentionally overcharged 340B program covered entities could be subject to significant monetary penalties. Over the course of the past few years, Celgene had received inquiries from Human Resources and Services Administration regarding the limited distribution networks for Revlimid, Pomalyst, and Thalomid and compliance with the 340B program.
Additionally, manufacturers who are found to have knowingly and intentionally overcharged 340B program covered entities could be subject to significant monetary penalties. Over the course of the past few years, Celgene had received inquiries from the Health Resources and Services Administration regarding the limited distribution networks for Revlimid, Pomalyst, and Thalomid and compliance with the 340B program.
A successful claim of patent or other intellectual property infringement could subject us to significant damages and/or an injunction preventing the manufacture, sale, or use of the affected product or products. Any of these events could have a material adverse effect on our profitability and financial condition. Adverse outcomes in legal matters could negatively affect our business.
A successful claim of patent or other intellectual property infringement could subject us to significant damages and/or an injunction preventing the manufacture, sale, or use of the affected product or products. Any of these events could have a material adverse effect on our profitability and financial condition. Legal matters could negatively affect our business.
The costs of compliance with such laws and regulations, or the negative results of non-compliance, could adversely affect our business, our operating results and the financial condition of our Company.
The costs of compliance with such laws and regulations, or the negative results of non-compliance, could adversely affect our business, our operating results and our financial condition.
We have faced, and may continue to face, audit challenges on how we apply a tax law or regulation. The ultimate resolution of any tax matters may result in payments greater or less than amounts accrued, which could have a negative impact on our provision for income taxes.
We have faced, and may continue to face, audit challenges on how we apply a tax law or regulation. The ultimate resolution of any tax matter may result in payments greater or less than amounts accrued, which could have a negative impact on our provision for income taxes.
As part of our broader integration strategy and alignment of our distribution model (post our acquisition of Celgene Corporation) we had announced that beginning March 1, 2022, we would recognize up to two designated 340B program contract pharmacy locations per 340B program hospital that lacks an entity-owned pharmacy.
As part of our broader integration strategy and alignment of our distribution model (post our acquisition of Celgene) we had announced that beginning March 1, 2022, we would generally recognize up to two designated 340B program contract pharmacy locations per 340B program hospital that lacks an entity-owned pharmacy.
Implementation of our environmental, social and governance goals and initiatives involves risks and uncertainties, 27 requires investments, and depends in part on third-party performance or data that is outside of our control. In addition, some stakeholders may disagree with the Company’s environmental, social and governance goals, targets or objectives.
Implementation of our environmental, social and governance aspirational goals and initiatives involves risks and uncertainties, requires investments, and depends in part on third-party performance or data that is outside of our control. In addition, some stakeholders may disagree with the Company’s environmental, social and governance aspirational goals, targets or objectives.
Our pretax income could be adversely affected if the royalty streams decline in future periods. For example, royalties related to Keytruda* decreased from 6.5% to 2.5% on January 1, 2024 and are expected to terminate on December 31, 2026, and royalties related to Tecentriq* are expected to terminate on December 31, 2026.
Our pretax income could be adversely affected as the royalty streams decline in future periods. For example, royalties related to Keytruda* decreased from 6.5% to 2.5% on January 1, 2024 and are expected to terminate on December 31, 2026, and royalties related to Tecentriq* are expected to terminate on December 31, 2026.
Using these third parties poses a number of risks, such as: (i) they may not perform to our standards or legal requirements, for example, in relation to the outsourcing of significant clinical development activities for innovative medicines to some contract research organizations; (ii) they may not produce reliable results; (iii) they may not perform in a timely manner; (iv) they may not maintain confidentiality of our proprietary information; (v) they may incur a significant cyberattack or business disruption; (vi) they may be subject to government orders or mandates that require them to give priority to the government and set aside pre-existing commercial orders; (vii) disputes may arise with respect to ownership of rights to technology developed with our partners; and (viii) disagreements could cause delays in, or termination of, the research, development or commercialization of the product or result in litigation or arbitration.
Using these third parties poses a number of risks, such as: (i) they may not perform to our standards or legal requirements, for example, in relation to the outsourcing of significant clinical development activities for innovative medicines to some contract research organizations; (ii) they may not produce reliable results; (iii) they may not perform in a timely manner; (iv) they may not maintain confidentiality of our proprietary information; (v) they may experience a cyber attack or business disruption; (vi) they may be subject to government orders or mandates that require them to give priority to the government and set aside pre-existing commercial orders; (vii) disputes may arise with respect to ownership of rights to technology developed with our partners; and (viii) disagreements could cause delays in, or termination of, the research, development or commercialization of the product or result in litigation or arbitration.
Further, the disclosure of non-public Company-sensitive information by our workforce or others, whether intentional or unintentional, through external media channels could lead to loss of trade secrets or other intellectual property, as well as the Company’s commercially sensitive information.
Further, the disclosure of non-public Company-sensitive information by our workforce or others, whether intentional or unintentional, through social media channels could lead to loss of trade secrets or other intellectual property, as well as the Company’s commercially sensitive information.
In addition, our future earnings could be negatively impacted by further changes in tax legislation, including changes in tax rates and tax base such as limiting, phasing-out or eliminating deductions or tax credits, increase taxing of certain excess income from intellectual property, revising tax law interpretations in domestic or foreign jurisdictions, changes in rules for earnings repatriations and changes in other tax laws in the U.S. or other countries.
In addition, our future earnings could be negatively impacted if our tax strategies are ineffective or by further changes in tax legislation, including changes in tax rates and tax base such as limiting, phasing-out or eliminating deductions or tax credits, increase taxing of certain excess income from intellectual property, revising tax law interpretations in domestic or foreign jurisdictions, changes in rules for earnings repatriations and changes in other tax laws in the U.S. or other countries.
There is no assurance that a particular product will enjoy market exclusivity for the full time period that appears in the estimates disclosed in this 2023 Form 10-K or that we assume when we provide our financial guidance. We face intense competition from other manufacturers and expect to see increasing market penetration of lower-priced generic products.
There is no assurance that a particular product will enjoy market exclusivity for the full time period that appears in the estimates disclosed in this 2024 Form 10-K or that we assume when we provide our financial guidance. We face intense competition from other biopharmaceutical companies and manufacturers and expect to see increasing market penetration of lower-priced generic products.
Additional clinical trials, head-to-head studies, adverse events reports following the use of our products over longer periods of time and studies that identify biomarkers (objective characteristics that can indicate a particular response to a product or therapy) that are conducted after obtaining marketing approval for our products, and regulatory changes to standards regarding safety, efficacy or labeling, may result in product label changes or other measures that could reduce the product's market acceptance and result in declining revenues.
Additional clinical trials, head-to-head studies, real-world data analyses, adverse events reports following the use of our products 29 over longer periods of time and studies that identify biomarkers (objective characteristics that can indicate a particular response to a product or therapy) that are conducted after obtaining marketing approval for our products, and regulatory changes to standards regarding safety, efficacy or labeling, may result in product label changes or other measures that could reduce the product's market acceptance and result in declining revenues.
Royalties have continued to represent a significant percentage of our pretax income, including royalties related to the divestiture of our diabetes business (including the transfer of certain future royalty rights pertaining to Amylin, Onglyza* and Farxiga* product sales), out-licensed intellectual property and the Merck patent infringement settlement. Pretax income generated from royalties was approximately $2.6 billion in 2023.
Royalties have continued to represent a significant percentage of our pretax income, including royalties related to the divestiture of our diabetes business (including the transfer of certain future royalty rights pertaining to Amylin, Onglyza* and Farxiga* product sales), out-licensed intellectual property and the Merck patent infringement settlement. Pretax income generated from royalties was approximately $2.4 billion in 2024.
Generic challenges to our products can also arise at any time, and our patents may not prevent the emergence of generic competition for our products.
Generic or biosimilar challenges to our products can also arise at any time, and our patents may not prevent the emergence of generic or biosimilar competition for our products.
For example, following certain adverse judicial decisions in the UK and the Netherlands, generic manufacturers have begun marketing generic versions of Eliquis in the UK and Netherlands, and may seek to market generic versions of Eliquis in additional countries in Europe, prior to the expiration of our patents, which may lead to additional infringement and invalidity actions involving Eliquis patents being filed in various countries in Europe.
For example, following certain adverse judicial decisions in the UK, Finland and Slovakia, generic manufacturers have begun marketing generic versions of Eliquis in these countries, and may seek to market generic versions of Eliquis in additional countries in Europe, prior to the expiration of our patents, which may lead to additional infringement and invalidity actions involving Eliquis patents being filed in various countries in Europe.
Risk Factors—We could lose market exclusivity of a product earlier than expected.” 29 Also, if one of our major products were to become subject to issues such as loss of patent protection, significant changes in demand, formulary access changes, material product liability, unexpected side effects, regulatory proceedings, negative publicity, supply disruption from our manufacturing operations or third-party supplier or a significant advancement of competing products, we may incur an adverse impact on our business, financial condition, results of operations or the trading price of our stock.
For additional information, see “—We could lose market exclusivity of a product earlier than expected.” Also, if one of our major products were to become subject to issues, such as loss of patent protection, significant changes in demand, formulary access changes, material product liability, unexpected side effects, regulatory proceedings, negative publicity, supply disruption from our manufacturing operations or third-party supplier or a significant advancement of competing products, we may incur an adverse impact on our business, financial condition, results of operations or the trading price of our stock.
Global economic and political risks pose significant challenges to a company’s growth and profitability and are difficult to mitigate. We generated approximately 30% of our revenues outside of the U.S. in 2023. As such, a global economic downturn could create or amplify a variety of risks to our business and could negatively affect our growth.
Global economic and political risks pose significant challenges to a company’s growth and profitability and are difficult to mitigate. We generated approximately 29% of our revenues outside of the U.S. in 2024. As such, a global economic downturn could create or amplify a variety of risks to our business and could negatively affect our growth.
Consequently, our future success is highly dependent on our pipeline of new products. There is a high rate of failure inherent in the research and development process for new drugs. As a result, there is a high risk that funds we invest in research programs will not generate financial returns.
Consequently, our future success is highly dependent on our pipeline of new products. There is a high rate of failure inherent in the research and development process for new drugs. As a result, there is a high risk that our investments in research programs will not generate financial returns.
Any such delays or difficulties in clinical development could also potentially lead to a material impairment of our intangible assets, including the $27.1 billion of other intangible assets as of December 31, 2023. We cannot predict or reasonably estimate the impact of any potential long-term changes to the healthcare industry from global economic and political events, including any future pandemics.
Any such delays or difficulties in clinical development could also potentially lead to a material impairment of our intangible assets, including the $23.3 billion of other intangible assets as of December 31, 2024. We cannot predict or reasonably estimate the impact of any potential long-term changes to the healthcare industry from global economic and political events, including any future pandemics.
Such legal matters include (i) intellectual property disputes; (ii) adverse decisions in litigation, including product safety and liability, consumer protection and commercial cases; (iii) anti-bribery regulations, such as the U.S.
Such legal matters include (i) intellectual property disputes; (ii) adverse decisions in litigation, including product safety and liability, consumer protection and commercial cases; (iii) matters related to anti-corruption or anti-bribery regulations, such as the U.S.
If we do not meet, are perceived not to meet, or if stakeholders disagree with, our environmental, social and governance goals, targets or objectives, we risk negative stakeholder reaction, including from proxy advisory services, as well as damage to our brand and reputation, reduced demand for our products or other negative impacts on our business and operations.
If we do not meet, are perceived not to meet, or if stakeholders disagree with, our environmental, social and governance aspirational goals, targets or objectives, we risk negative stakeholder reaction, including from proxy advisory services, as well as damage to our brand and reputation, reduced demand for our products, inability to attract and retain employee talent or other negative impacts on our business and operations.
Moreover, due to the substantial amount of debt that we incurred to finance the cash portion of the Celgene, MyoKardia and Mirati acquisitions, and intend to incur in connection with the Karuna and RayzeBio acquisitions, there can be no assurance of when we will be able to expand our business development capacity.
Moreover, due to the substantial amount of debt that we incurred to finance the cash portion of the Celgene, MyoKardia, Mirati, Karuna and RayzeBio acquisitions, there can be no assurance of when we will be able to expand our business development capacity.
Generally, these government prices apply nine years (for small molecule drugs) or 13 years (for biological products) following FDA approval and will be capped at a statutory ceiling price that is likely to represent a significant discount from average prices to wholesalers and direct purchasers. In August 2023, the U.S.
Generally, these government prices apply nine years (for small molecule drugs) or 13 years (for biological products) following FDA approval and will be capped at a statutory ceiling price that is likely to represent a significant discount from average prices to wholesalers and direct purchasers.
Generic and biosimilar product manufacturers as well as other groups seeking financial gain are also increasingly seeking to challenge patents before they expire, and we could face earlier-than-expected competition for any products at any time.
Generic and biosimilar product manufacturers as well as other groups seeking financial gain are also increasingly seeking to challenge patents before they expire, and we have faced and may continue to face earlier-than-expected competition for any products at any time.
The prevalence of counterfeit medicines is an industry-wide issue due to a variety of factors, including the adoption of e-commerce, which increased during the COVID-19 pandemic, greatly enhancing consumers’ ability to obtain prescriptions and other medical treatments via the internet in lieu of traditional brick and mortar pharmacies.
The prevalence of counterfeit medicines is an industry-wide issue due to a variety of factors, including the adoption of e-commerce, greatly enhancing consumers’ ability to obtain prescriptions and other medical treatments via the internet in lieu of traditional brick and mortar pharmacies.
Beginning in January 2025, under the IRA, the 70 percent CGDP discount will be replaced by a 10 percent manufacturer discount for all Medicare Part D beneficiaries that have met their deductible and incurred out of pocket drug costs below a $2,000 threshold and a 20 percent discount for beneficiaries that have incurred out of pocket drug costs above the $2,000 threshold under the new Part D benefit redesign.
As of January 2025, under the IRA, the Part D benefit redesign replaced the 70 percent CGDP discount with a 10 percent manufacturer discount for all Medicare Part D beneficiaries that have met their deductible and incurred out of pocket drug costs below a $2,000 threshold and a 20 percent discount for beneficiaries that have incurred out of pocket drug costs above the $2,000 threshold under the new Part D benefit redesign.
In addition, diversion of products from their authorized market into other channels may result in reduced revenues and negatively affect our profitability. Increased use of social media platforms presents risks and challenges. We are increasing our use of social media to communicate Company news and events.
In addition, diversion of products from their authorized market into other channels may result in reduced revenues and negatively affect our profitability. Use of social media platforms can present risks and challenges. We use social media to communicate Company news and events.
It is also possible that changes in the 31 healthcare system could impose additional burdens on clinical trials, which could increase the costs of sponsoring clinical trials or lead to additional delays or difficulties with completing clinical trials. We may also experience additional pricing pressures and/or increased governmental regulation.
It is possible that changes in the healthcare system could impose additional burdens on clinical trials, which could increase the costs of sponsoring clinical trials or lead to additional delays or difficulties with completing clinical trials. We may also experience additional pricing pressures, shifts in the U.S. payer channel mix and/or increased governmental regulation.
Regulators are imposing new data privacy and security requirements, including new and greater monetary fines or penalties for privacy violations, and jurisdictions where we operate have passed, or continue to propose, data privacy legislation and or regulations.
Regulators are imposing new cybersecurity and data 28 protection, storage and privacy requirements, including new and greater monetary fines or penalties for privacy violations, and jurisdictions where we operate have passed, or continue to propose, data privacy legislation and or regulations.
In some countries, patent protection is significantly weaker than in the U.S. or in the EU; political and social pressure has also pushed legislation and other measures that promote the use of generic and biosimilar products. For additional information, see “Item 1A.
In some countries, patent protection is significantly weaker than in the U.S. or in the EU; political and social pressure has also pushed legislation and other measures that promote the use of generic and biosimilar products.
Information Technology and Cybersecurity Risks We are dependent on information technology systems and face risk of cybersecurity incidents that could disrupt our business and result in theft of proprietary and confidential information.
Information Technology and Cybersecurity Risks We are dependent on information technology systems, including artificial intelligence programs, and face risk of cybersecurity incidents that could disrupt our business and result in theft of proprietary, confidential and personal information.
We expect that Revlimid, Eliquis, and Opdivo will represent a significant percentage of our revenue, earnings and cash flows during the next few years. A reduction in revenue from any of these products due to loss of market exclusivity or other factors could adversely impact our earnings and cash flows. For additional information, see “Item 1A.
We expect that Eliquis, Opdivo, Orencia and Yervoy will represent a significant percentage of our revenue, earnings and cash flows during the next few years. A reduction in revenue from any of these products due to loss of market exclusivity or other factors could adversely impact our earnings and cash flows.
Our ability to replace revenue from products that lose patent protection is directly dependent on our ability to successfully commercialize new products in a timely manner. As is common in the pharmaceutical industry, BMS expects that sales of its key brand products like Eliquis, Revlimid, Pomalyst, Sprycel and Abraxane will decline after the loss of market exclusivity for such products.
Our ability to replace revenue from products that lose patent protection is directly dependent on our ability to successfully develop and commercialize new products in a timely manner. As is common in the pharmaceutical industry, BMS expects that sales of its branded products like Orencia, Eliquis and Opdivo will decline after the loss of market exclusivity for such products.
Business—Government Regulation,” “Item 1. Business—Pricing, Price Constraints and Market Access” and “—Adverse outcomes in legal matters could negatively affect our business.” Similarly, the legislative and regulatory environment regarding privacy and data protection is continuously evolving and the subject of significant attention by regulators and private parties globally.
Business—Pricing, Price Constraints and Market Access” and “—Legal matters could negatively affect our business.” Similarly, the legislative and regulatory environment regarding cybersecurity, data protection, storage and privacy is continuously evolving and the subject of significant attention by regulators and private parties globally.
We could also face potential other negative consequences stemming from future pandemics or global events, including but not limited to increased cyber threats to us and our partners such as cyber attacks and outages.
We could also face other potential negative consequences stemming from future pandemics or global events, including but not limited to increased cyber threats to us and our partners such as cyber attacks and outages, and challenges related to the safety of our employees and safe occupancy.
In particular, the IRA will have the effect of reducing prices and reimbursements for certain of our products, which could significantly impact our business. Under the IRA, the U.S Department of Health and Human Services can effectively set prices for certain single-source drugs and biologics reimbursed under Medicare Part B and Part D.
In particular, the IRA will have the effect of reducing prices and reimbursements for certain of our products, which could significantly impact our business. Under the IRA, the HHS can effectively set prices for units of certain single-source drugs and biologics reimbursed under Medicare Part B, Medicare Advantage and Part D.
We are also unable to predict if and when any changes to laws or regulatory policies will occur and how they will affect our business and particularly our pipeline of new products. Regulatory approval delays are especially common when a product is expected to have a REMS program, as required by the U.S.
We are also unable to predict if and when any changes to laws or regulatory policies will occur and how they will affect our business and particularly our pipeline of new products. Commercialization launch delays are especially common when a product is expected to have a REMS program, as required by the FDA to address significant risk/benefit issues.
Although we believe that we have complied with, and continue to comply with, all applicable legal requirements, additional legal or legislative changes with respect to the 340B program may cause us to update our approach.
Whether or how such laws may impact our business remains uncertain. Although we believe that we have complied with, and continue to comply with, all applicable legal requirements, additional legal or legislative changes with respect to the 340B program may cause us to update our approach.
As a result, even slight deviations at any point in the production process for our CAR-T cell therapies or in material used in our CAR-T cell therapies could result in loss of product or regulatory remedial action, which could adversely affect our future anticipated revenues and/or profitability related to our CAR-T cell therapies. 26 Regulatory, Intellectual Property, Litigation, Tax and Legal Compliance Risks Litigation claiming infringement of intellectual property may adversely affect our future revenues and operating earnings.
As a result, even slight deviations at any point in the production process for our CAR-T cell therapies or in material used in our CAR-T cell therapies could result in loss of product or regulatory remedial action, which could adversely affect our future anticipated revenues and/or profitability related to our CAR-T cell therapies.
In some cases, manufacturers may seek regulatory approval by submitting their own clinical study data to obtain marketing approval or choose to launch a generic product “at risk” before the expiration of the applicable patent(s) and/or before the final resolution of related patent litigation.
The licenses will no longer be volume-limited beginning on January 31, 2026. 26 In some cases, manufacturers may seek regulatory approval by submitting their own clinical study data to obtain marketing approval or choose to launch a generic product “at risk” before the expiration of the applicable patent(s) and/or before the final resolution of related patent litigation.
FDA to address significant risk/benefit issues, and we expect that certain of our future key products will be distributed in the U.S. primarily through a REMS program. The inability to bring a product to market or a significant delay in the expected regulatory approval and related launch date of a new product could negatively impact our revenues and earnings.
Certain of our future key products may be required to be distributed in the U.S. through 25 a REMS program. The inability to bring a product to market or a significant delay in the expected regulatory approval and related launch date of a new product could negatively impact our revenues and earnings.
Failure to comply with these current and future laws could result in significant penalties and reputational harm and could have a material adverse effect on our business and results of operations.
Failure to comply with these laws could result in significant penalties, including potential exclusion from federal healthcare programs, and reputational harm and could have a material adverse effect on our business and results of operations.
Risk Factors—We could lose market exclusivity of a product earlier than expected.” In addition, we face competition from new products entering the market, particularly in IO.
For additional information, see “—We could lose market exclusivity of a product earlier than expected.” In addition, we face competition from new products entering the market.
In the pharmaceutical and biotechnology industries, the majority of an innovative product’s commercial value is realized during its market exclusivity period.
We could lose market exclusivity of a product earlier than expected. In the pharmaceutical and biotechnology industries, the majority of an innovative product’s commercial value is realized during its market exclusivity period.
For example, as a result of patent settlements, generic entry for Revlimid in the United Kingdom began on January 18, 2022, and in various other European countries on February 18, 2022. Similarly, in the U.S., following patent settlements, certain companies were granted volume-limited licenses to sell generic lenalidomide in the U.S. commencing in March 2022 or thereafter.
For example, as a result of patent settlements, generic entry for Revlimid in the UK began on January 18, 2022, and in various other European countries on February 18, 2022. Similarly, in the U.S., following patent settlements, certain companies have begun marketing generic lenalidomide pursuant to volume-limited licenses.
The imposition of the excise tax on repurchases of our shares may increase the cost to us of making repurchases and may cause our Board to reduce the number of shares repurchased pursuant to our share repurchase program.
The IRA imposes a non-deductible 1% excise tax on our net repurchases of shares after December 31, 2022. The imposition of the excise tax on repurchases of our shares may increase the cost to us of making repurchases and may cause our Board to reduce the number of shares repurchased pursuant to our share repurchase program.
Strategic, Business Development and Employee Attraction and Retention Risks We depend on several key products for most of our revenues, cash flows and earnings. We derive a majority of our revenue and earnings from several key products.
These risks may result in an adverse impact on our business, financial condition or results of operations. Strategic, Business Development and Employee Attraction and Retention Risks We depend on several key products for most of our revenues, cash flows and earnings. We derive a majority of our revenue and earnings from several key products.
Additionally, certain study results, especially from head-to-head studies, could affect a product’s formulary listing, which could also adversely affect revenues. 28 In addition, if safety or efficacy concerns are raised about a third party's product in the same class as one of our products, those concerns could implicate the entire class and this, in turn, could have an adverse impact on the availability or commercial viability of our product(s) as well as other products in the class.
In addition, if safety or efficacy concerns are raised about a third party's product in the same class as one of our products, those concerns could implicate the entire class and this, in turn, could have an adverse impact on the availability or commercial viability of our product(s) as well as other products in the class.
This could reduce our financial flexibility to continue capital investments, develop new products and declare future dividends. For example, following the announcements of recent acquisitions, Standard & Poor’s downgraded BMS’s long term-credit rating from A+ to A (with a stable long-term credit outlook). Adverse changes in U.S. and global economic and political conditions could adversely affect our operations and profitability.
For example, following the December 2023 announcements of previous acquisitions, Standard & Poor’s downgraded BMS’s long term-credit rating from A+ to A (with a stable long-term credit outlook). Adverse changes in U.S. and global economic and political conditions could adversely affect our operations and profitability.
We may also experience delays in the initiation and enrollment of patients in our clinical trials as a consequence of any future pandemic. We may not be able to fully mitigate these delays, which could negatively impact the timing of our pipeline development programs and expected future revenues and/or cash flows.
We may not be able to fully mitigate these delays, which could negatively impact the timing of our pipeline development programs and expected future revenues and/or cash flows.
In addition, we could, at any time, decide not to buy back any more shares in the market, or reduce the number of shares repurchased under our share repurchase program, which could also adversely affect our stock price. The IRA imposes a 1% excise tax on our net repurchases of shares after December 31, 2022.
A reduction or elimination of our dividend payments or dividend program could adversely affect our stock price. In addition, we could, at any time, decide not to buy back any more shares in the market, or reduce the number of shares repurchased under our share repurchase program, which could also adversely affect our stock price.
It is possible that global economic and political events, including any future pandemic, could exacerbate any of the other risks described in this 2023 Form 10-K as well. There can be no guarantee that we will pay dividends or repurchase stock. The declaration, amount and timing of any dividends fall within the discretion of our Board.
It is possible that global economic and political events, including changes to the geopolitical relationship between the U.S. and China, other geopolitical events and conflicts, and any future pandemic, could exacerbate any of the other risks described in this 2024 Form 10-K as well. There can be no guarantee that we will pay dividends or repurchase stock.
In addition, the U.S. healthcare industry is highly regulated and subject to frequent and substantial changes, including as a result of new judicial or governmental decisions. For example, Congress passed the Food and Drug Omnibus Reform Act in December 2022, which gave the U.S.
In addition, the U.S. healthcare industry is highly regulated and subject to frequent and substantial changes, including as a result of new judicial or governmental decisions.
We are facing increasing competition for a limited pool of qualified individuals from numerous pharmaceutical and biotechnology companies, universities, government entities, research institutions, companies seeking to enter the healthcare space, and companies in other industries. We cannot be sure that we will be able to retain quality talent or that the costs of doing so will not materially increase.
We are facing increasing competition for a limited pool of qualified individuals from numerous pharmaceutical and biotechnology companies, universities, government entities, research institutions, companies seeking to enter the healthcare space, and companies in other industries.
We have significant operations in Europe, including for manufacturing and distribution. The results of our operations could be negatively impacted by any member country exiting the eurozone monetary union or EU.
We have significant operations in Europe, including for manufacturing and distribution. The results of our operations could be negatively impacted by any member country exiting the eurozone monetary union or EU. Additionally, our business and operations may be adversely affected by political volatility, conflicts or crises in individual countries or regions, including terrorist activities or war and pandemics or epidemics.
There can be no assurance that our key product candidates would prove to be safe and effective or as safe and effective as other competing products, or that, even if approved, any such products will become commercially successful for all approved indications. We could lose market exclusivity of a product earlier than expected.
This may result in further uncertainty as to when potential new products will be approved and commercialized. There can be no assurance that our key product candidates would prove to be safe and effective or as safe and effective as other competing products, or that, even if approved, any such products will become commercially successful for all approved indications.
New or revised accounting standards, rules and interpretations could result in changes to the recognition of income and expense that may materially and adversely affect our financial results. 30 If the execution or implementation of acquisitions, divestitures, alliances, joint ventures and other portfolio actions is not successful, it could adversely impact our financial condition, cash flows and results of operations.
If the execution or implementation of acquisitions, divestitures, alliances, joint ventures and other portfolio actions is not successful, it could adversely impact our financial condition, cash flows and results of operations.
Furthermore, a future epidemic or pandemic could create material staffing shortages at our manufacturing sites which could disrupt the supply of our products. It is also possible that we may experience supply chain interruptions as a result of quarantines, shelter-in-place and other governmental orders and policies, travel restrictions, airline and cargo capacity and route reductions.
It is also possible that we may experience supply chain interruptions as a result of quarantines, shelter-in-place and other governmental orders and policies, travel restrictions, airline and cargo capacity and route reductions. We may also experience delays in the initiation and enrollment of patients in our clinical trials as a consequence of any future pandemic.
The Board’s decision will depend on many factors, including our financial condition, earnings, capital requirements, debt service obligations, industry practice, legal requirements, regulatory constraints and other factors that our Board may deem relevant. A reduction or elimination of our dividend payments or dividend program could adversely affect our stock price.
The declaration, amount and timing of any dividends fall within the discretion of our Board. The Board’s decision will depend on many factors, including our financial condition, earnings, capital requirements, debt service obligations, industry practice, legal requirements, regulatory constraints and other factors that our Board may deem relevant.
Failure to do so in the short-term or long-term can have a material adverse effect on our business, results of operations, cash flow, financial condition and prospects.
Failure to do so in the short-term or long-term can have a material adverse effect on our business, results of operations, cash flow, financial condition and prospects. We may also choose to no longer pursue certain programs from time to time as we periodically review our research and development programs and seek to prioritize our pipeline investments.
For example, if any of our third-party providers suffer from limited solvency because of global economic conditions, it could negatively impact our operating model and our business. Similarly, global events such as the Ukraine-Russia conflict can increase the volatility of the financial markets, foreign currency exchanges and interest rates.
For example, if any of our third-party providers suffer from limited solvency because of global economic conditions, it could negatively impact our operating model and our business.

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Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

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Biggest changeThe information security team responsible for managing and implementing the Company’s cybersecurity and data privacy programs has many years of valuable business experience managing risks from cybersecurity threats and data privacy breaches and developing and implementing cybersecurity and data privacy policies and procedures.
Biggest changeOur CISO has led our enterprise-wide cybersecurity risk management, strategy, policy, standards and processes since 2018, and the information security team responsible for managing and implementing the Company’s cybersecurity and data privacy programs has many years of valuable business experience effectively addressing cybersecurity risks and developing related robust policies and procedures.
For a discussion of these risks, see “Item 1A—Risk Factors— Information Technology and Cybersecurity Risks —We are dependent on information technology and our systems and infrastructure face certain risks, including from cybersecurity incidents and data leakage.” 33 Governance The Company’s cybersecurity and data privacy programs are implemented and overseen by the Company’s Chief Information Security Officer (“CISO”), the Executive Vice President, Chief Digital and Technology Officer, and senior management.
For a discussion of these risks, see “Item 1A—Risk Factors— Information Technology and Cybersecurity Risks —We are dependent on information technology and our systems and infrastructure face certain risks, including from cybersecurity incidents and data leakage.” Governance The Company’s cybersecurity and data privacy programs are implemented and overseen by the Company’s Chief Information Security Officer (“CISO”), the Executive Vice President, Chief Digital and Technology Officer, and senior management.
Our Audit Committee, which consists solely of independent directors, oversees the Company’s overall enterprise risk assessment and risk management policies and guidelines, including risks related to cybersecurity matters. Our Audit Committee reviews, discusses with management and oversees the Company’s information security and data protection programs.
Our Audit Committee, which consists solely of independent directors, oversees the Company’s overall enterprise risk assessment and risk management policies and guidelines, including risks related to cybersecurity matters. Our Audit Committee reviews, discusses with management at least annually and oversees the Company’s information security and data protection programs.
The assessment methodology is based on risk and relies on the data, access, connectivity, and criticality of the services that the third-party offers. As noted, we also conduct tabletop exercises to identify gaps in our supply chain resilience so we can implement improvements.
The assessment methodology is based on risk and relies on the data, access, connectivity, and criticality of the services that the third-party offers. As noted, we also conduct tabletop exercises to identify improvement opportunities in our supply chain resilience.
We maintain relationships with law enforcement, government agencies, forensic investigators, and legal counsel to inform our cybersecurity and data privacy programs. As of December 31, 2023, and through the date of this filing, we are not aware of any material cybersecurity incidents that have impacted the Company.
We maintain relationships with law enforcement, government agencies, forensic investigators, and legal counsel to inform our cybersecurity and data privacy programs. 35 While we and our third-party vendors are regularly subject to cybersecurity attacks and incidents, as of December 31, 2024 and through the date of this filing, we are not aware of any material cybersecurity incidents that have impacted the Company in the last three years.
Item 1C. CYBERSECURITY Risk Management and Strategy The Company manages cybersecurity risk as part of our overall enterprise risk management strategy, which is overseen by the Audit Committee and the Board. The Company employs robust cybersecurity and data privacy programs that are largely aligned to, among others, the U.S.
Item 1C. CYBERSECURITY Risk Management and Strategy The Company manages cybersecurity risk as part of our overall enterprise risk management strategy, which is overseen by the Audit Committee and the Board. The Company employs robust cybersecurity and data privacy programs that are designed to assess, identify and manage material risks from cybersecurity threats.
Our employees are exposed to data-driven cybersecurity awareness campaigns and training in order to keep pace with industry standards, evolving challenges and innovative solutions with respect to information security, data privacy, and cybersecurity risks to the organization.
Our employees are exposed to data-driven cybersecurity awareness campaigns and annual training in order to keep pace with industry standards, evolving challenges and innovative solutions with respect to information security, data privacy, and cybersecurity risks to the organization. In many regions, our employees receive a monthly snapshot of their cyber behaviors and are given a rating for their cyber vigilance.
National Institute of Standards and Technology Cybersecurity Framework to assess, identify and manage material risks from cybersecurity threats. We are constantly evolving our cyber defenses to minimize impacts from cyber threats by using a multi-pronged approach that helps safeguard our assets and data.
These programs are independently assessed every three years against the U.S. National Institute of Standards and Technology Cybersecurity Framework ("NIST"). We are constantly evolving our cyber defenses to minimize impacts from cyber threats by using a multi-pronged approach that helps safeguard our assets and data.
We perform periodic tabletop exercises annually to test our incident response procedures, identify gaps and improvement opportunities and exercise team preparedness. We engage with third parties to separately conduct cyber assessments on a recurring basis and assist with containment and remediation efforts. In addition, third-party technology and analytics are utilized to identify potential vulnerabilities.
These tabletop exercises focus on various aspects of cybersecurity events, including patient and employee impact, operational resilience and effectiveness and communication coordination. We engage with third parties to separately conduct cyber assessments on a recurring basis and assist with containment and remediation efforts. In addition, third-party technology and analytics are utilized to identify potential vulnerabilities.
Added
We perform multiple tabletop exercises across various levels of the Company each year to test our incident response procedures, enhance our resiliency by seeking to ensure business continuity during potential extended digital outages, identify improvement opportunities and increase employee awareness and preparedness.
Added
The CISO reports to the Chief Digital & Technology Officer, who in turn reports to the CEO. Collectively, our CISO and senior management team have extensive experience in information security and information technology risk management, including cybersecurity.

Item 2. Properties

Properties — owned and leased real estate

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Biggest changeBusiness—Manufacturing and Quality Assurance.” Our significant manufacturing and R&D locations by geographic area were as follows at December 31, 2023: Manufacturing R&D United States 6 8 Europe 1 1 Total 7 9
Biggest changeBusiness—Manufacturing and Quality Assurance.” Our significant manufacturing and R&D locations by geographic area were as follows at December 31, 2024: Manufacturing R&D United States 4 8 International 2 2 Total 6 10
We also believe that none of our properties is subject to any material encumbrance, easement or other restriction that would detract materially from its value or impair its use in the operation of the business. For further information about our manufacturing properties, refer to “Item 1.
We also believe that none of our properties are subject to any material encumbrance, easement or other restriction that would detract materially from their value or impair their use in the operation of the business. For further information about our manufacturing properties, refer to “Item 1.

Item 4. Mine Safety Disclosures

Mine Safety Disclosures — required of mining issuers

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Biggest changeExecutive Vice President, Chief Medical Officer, Head of Development Member of the Leadership Team 55 2017 to 2019 – Executive Vice President, Head of Oncology Development, Novartis 2019 to 2023 – Executive Vice President, Chief Medical Officer, Global Drug Development 2023 to present – Executive Vice President, Chief Medical Officer, Head of Development Lynelle Hoch President, Cell Therapy Organization Member of the Leadership Team 51 2016 to 2019– Vice President, Immuno-Oncology Marketing 2019 to 2021 – General Manager, Ireland & UK, Major Markets 2021 to 2023 – Senior Vice President, Global Cell Therapy Franchise Lead 2023 to present – President, Cell Therapy Organization Adam Lenkowsky Executive Vice President, Chief Commercialization Officer Member of the Leadership Team 52 2016 to 2019 – Head of US Oncology 2019 to 2022 – Senior Vice President, General Manager of U.S.
Biggest changeExecutive Vice President, Chief Medical Officer, Head of Development Member of the Leadership Team 56 2017 to 2019 – Executive Vice President, Head of Oncology Development, Novartis 2019 to 2023 – Executive Vice President, Chief Medical Officer, Global Drug Development 2023 to present – Executive Vice President, Chief Medical Officer, Head of Development Lynelle Hoch President, Cell Therapy Organization Member of the Leadership Team 52 2016 to 2019– Vice President, Immuno-Oncology Marketing 2019 to 2021 – General Manager, Ireland & UK, Major Markets 2021 to 2023 – Senior Vice President, Global Cell Therapy Franchise Lead 2023 to present – President, Cell Therapy Organization Phil Holzer Senior Vice President & Controller 49 2015 to 2018 – Chief Audit Officer 2018 to 2019 – Vice President & Head of Finance, Research & Development 2019 to 2021 – Senior Vice President, Enterprise Integration Management 2021 to 2024 – Senior Vice President, Finance, Tax & Treasury 2024 to present – Senior Vice President & Controller Adam Lenkowsky Executive Vice President, Chief Commercialization Officer Member of the Leadership Team 53 2016 to 2019 – Head of US Oncology 2019 to 2022 – Senior Vice President, General Manager of U.S.
Oncology, Immunology & Cardiovascular 2022 to 2023 Senior Vice President, Head of Major Markets 2023 to present – Executive Vice President, Chief Commercialization Officer Sandra Leung Executive Vice President, General Counsel Member of the Leadership Team 63 2015 to present – Executive Vice President, General Counsel Greg Meyers Executive Vice President, Chief Digital and Technology Officer Member of the Leadership Team 51 2014 to 2018 – Corporate Vice President and Chief Information Officer, Motorola Solutions 2018 to 2022 – Group Chief Information and Digital Officer, Syngenta Group 2022 to present – Executive Vice President, Chief Digital and Technology Officer Robert Plenge, M.D., Ph.D.
Oncology, Immunology & Cardiovascular 2022 to 2023 Senior Vice President, Head of Major Markets 2023 to present – Executive Vice President, Chief Commercialization Officer Sandra Leung Executive Vice President, General Counsel Member of the Leadership Team 64 2015 to present – Executive Vice President, General Counsel Greg Meyers Executive Vice President, Chief Digital and Technology Officer Member of the Leadership Team 52 2014 to 2018 – Corporate Vice President and Chief Information Officer, Motorola Solutions 2018 to 2022 – Group Chief Information and Digital Officer, Syngenta Group 2022 to present – Executive Vice President, Chief Digital and Technology Officer Robert Plenge, M.D., Ph.D.
Executive Vice President, Chief Research Officer, Head of Research Member of the Leadership Team 53 2017 to 2019 – Vice President Inflammation and Immunology, Thematic Center of Excellence Unit, Celgene Corporation 2019 to 2021 – Senior Vice President, Immunology, Cardiovascular & Fibrosis, Thematic Research Center 2021 to 2023 – Senior Vice President, Immunology, Cardiovascular & Fibrosis, Thematic Research Center, and Head of Translational Medicine 2023 to 2023 – Senior Vice President and Head of Discovery and Translational Sciences 2023 to present – Executive Vice President, Chief Research Officer, Head of Research Amanda Poole Executive Vice President, Chief Human Resources Officer Member of the Leadership Team 49 2017 to 2019 – Vice President, Head of Human Resources, Global Product Development & Supply 2019 to 2020 – Vice President, Head of BMS/Celgene Integration 2020 to 2022 – Senior Vice President, Head of Human Resources, Commercialization 2022 to 2024 – Senior Vice President, People Strategy, Solutions & Services 2024 to present – Executive Vice President, Chief Human Resources Officer Karin Shanahan Executive Vice President, Global Product Development & Supply Member of the Leadership Team 59 2013 to 2018 – Senior Vice President and Chief Operating Officer, Global Operations, Teva Pharmaceuticals 2018 to 2022 – Senior Vice President, Global Biologics & Sterile Operations, Merck 2022 to present – Executive Vice President, Global Product Development & Supply 35 PART II
Executive Vice President, Chief Research Officer, Head of Research Member of the Leadership Team 54 2017 to 2019 – Vice President Inflammation and Immunology, Thematic Center of Excellence Unit, Celgene Corporation 2019 to 2021 – Senior Vice President, Immunology, Cardiovascular & Fibrosis, Thematic Research Center 2021 to 2023 – Senior Vice President, Immunology, Cardiovascular & Fibrosis, Thematic Research Center, and Head of Translational Medicine 2023 to 2023 – Senior Vice President and Head of Discovery and Translational Sciences 2023 to present – Executive Vice President, Chief Research Officer, Head of Research Amanda Poole Executive Vice President, Chief People Officer Member of the Leadership Team 50 2017 to 2019 – Vice President, Head of Human Resources, Global Product Development & Supply 2019 to 2020 – Vice President, Head of BMS/Celgene Integration 2020 to 2022 – Senior Vice President, Head of Human Resources, Commercialization 2022 to 2024 – Senior Vice President, People Strategy, Solutions & Services 2024 to present – Executive Vice President, Chief People Officer Karin Shanahan Executive Vice President, Global Product Development & Supply Member of the Leadership Team 60 2013 to 2018 – Senior Vice President and Chief Operating Officer, Global Operations, Teva Pharmaceuticals 2018 to 2022 – Senior Vice President, Global Biologics & Sterile Operations, Merck 2022 to present – Executive Vice President, Global Product Development & Supply 37 PART II
Item 4. MINE SAFETY DISCLOSURES. Not applicable. 34 PART IA Information about our Executive Officers Listed below is information on our executive officers as of February 13, 2024.
Item 4. MINE SAFETY DISCLOSURES. Not applicable. 36 PART IA Information about our Executive Officers Listed below is information on our executive officers as of February 12, 2025.
Name and Current Position Age Employment History for the Past 5 Years Christopher Boerner, Ph.D. Chief Executive Officer Member of the Leadership Team 53 2015 to 2017 – President and Head of U.S.
Name and Current Position Age Employment History Christopher Boerner, Ph.D. Chair of the Board and Chief Executive Officer Member of the Leadership Team 54 2015 to 2017 – President and Head of U.S.
Commercial 2017 to 2018 – President and Head, International Markets 2018 to 2023 – Executive Vice President, Chief Commercialization Officer 2023 to 2023 – Executive Vice President, Chief Operating Officer 2023 to present – Chief Executive Officer Giovanni Caforio, M.D.
Commercial 2017 to 2018 – President and Head, International Markets 2018 to 2023 – Executive Vice President, Chief Commercialization Officer 2023 to 2023 – Executive Vice President, Chief Operating Officer 2023 to 2024 – Chief Executive Officer 2024 to present – Chair of the Board and Chief Executive Officer David V.
Elkins Executive Vice President and Chief Financial Officer Member of the Leadership Team 55 2014 to 2017 – Group Vice President and Chief Financial Officer, Consumer and Consumer Medicines, Johnson & Johnson 2017 to 2018 – Worldwide Vice President and Chief Financial Officer, Consumer Products, Medical Development and Corporate Functions, Johnson & Johnson 2018 to 2019 – Chief Financial Officer, Celgene Corporation 2019 to present – Executive Vice President and Chief Financial Officer Cari Gallman Executive Vice President, Corporate Affairs Member of the Leadership Team 44 2015 to 2018 – Senior Counsel, US Legal 2018 to 2019 – Assistant General Counsel, Oncology Legal 2019 to 2021 – Vice President, Assistant General Counsel, Worldwide Oncology 2021 to 2023 – Senior Vice President, Chief Compliance Officer 2023 to present – Executive Vice President, Corporate Affairs Sharon Greenlees Senior Vice President, Corporate Controller 52 2016 to 2018 – Vice President of Investor Relations, AbbVie Inc. 2018 to 2020 – Head of Pricing, U.S.
Elkins Executive Vice President and Chief Financial Officer Member of the Leadership Team 56 2014 to 2017 – Group Vice President and Chief Financial Officer, Consumer and Consumer Medicines, Johnson & Johnson 2017 to 2018 – Worldwide Vice President and Chief Financial Officer, Consumer Products, Medical Development and Corporate Functions, Johnson & Johnson 2018 to 2019 – Chief Financial Officer, Celgene Corporation 2019 to present – Executive Vice President and Chief Financial Officer Cari Gallman Executive Vice President, Corporate Affairs Member of the Leadership Team 45 2015 to 2018 – Senior Counsel, US Legal 2018 to 2019 – Assistant General Counsel, Oncology Legal 2019 to 2021 – Vice President, Assistant General Counsel, Worldwide Oncology 2021 to 2023 – Senior Vice President, Chief Compliance Officer 2023 to present – Executive Vice President, Corporate Affairs Benjamin Hickey President, RayzeBio Organization Member of the Leadership Team 50 2014 to 2016 – Vice President, Commercial, Immuno-Oncology 2016 to 2018 – General Manager, UK & Ireland 2018 to 2020 – Senior Vice President, Chief Commercial Officer, Halozyme Therapeutics 2020 to 2024 – Chief Commercial Officer, Head of Business Development, Mirati Therapeutics 2024 to present – President, RayzeBio Organization, Bristol-Myers Squibb Company Samit Hirawat, M.D.
Removed
Executive Chairman of the Board Member of the Leadership Team 59 2015 to 2017 – Chief Executive Officer and Director of the Company 2017 to 2023 – Chairman of the Board and Chief Executive Officer 2023 to present – Executive Chairman of the Board David V.
Removed
Commercial, AbbVie Inc. 2020 to 2021 – Head of Supply Chain Finance, AbbVie Inc. 2021 to 2022 – Vice President and Controller, R&D Finance and Operations, AbbVie Inc. 2022 to present – Senior Vice President, Corporate Controller Samit Hirawat, M.D.

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

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Biggest changeThe stock price performance on the following graph is not necessarily indicative of future stock price performance. 2019 2020 2021 2022 2023 Bristol Myers Squibb $ 127.74 $ 128.26 $ 131.95 $ 157.00 $ 115.95 S&P 500 131.49 155.68 200.37 164.08 207.21 Peer Group 117.27 119.64 147.25 163.08 166.38 36 Issuer Purchases of Equity Securities The following table summarizes the surrenders of our equity securities during the three months ended December 31, 2023: Period Total Number of Shares Purchased (a) Average Price Paid per Share (a) Total Number of Shares Purchased as Part of Publicly Announced Programs (b) Approximate Dollar Value of Shares that May Yet Be Purchased Under the Programs (b) Dollars in millions, except per share data October 1 to 31, 2023 68,146 $ 57.26 — $ 2,014 November 1 to 30, 2023 (c) 13,875,165 13,853,518 2,014 December 1 to 31, 2023 36,099 50.36 — 5,014 Three months ended December 31, 2023 13,979,410 13,853,518 (a) Includes shares repurchased as part of publicly announced programs and shares of common stock surrendered to the Company to satisfy tax withholding obligations in connection with the vesting of awards under our long-term incentive program.
Biggest changeThe stock price performance on the following graph is not necessarily indicative of future stock price performance. 2020 2021 2022 2023 2024 Bristol Myers Squibb $ 100.41 $ 103.30 $ 122.91 $ 90.77 $ 105.12 S&P 500 118.40 152.39 124.79 157.59 197.02 Peer Group 102.02 125.57 139.06 141.88 153.64 38 Issuer Purchases of Equity Securities The following table summarizes the surrenders of our equity securities during the three months ended December 31, 2024: Period Total Number of Shares Purchased (a) Average Price Paid per Share (a) Total Number of Shares Purchased as Part of Publicly Announced Programs (b) Approximate Dollar Value of Shares that May Yet Be Purchased Under the Programs (b) Dollars in millions, except per share data October 1 to 31, 2024 79,154 $ 53.57 — $ 5,014 November 1 to 30, 2024 28,401 54.41 — 5,014 December 1 to 31, 2024 27,385 58.28 — 5,014 Three months ended December 31, 2024 134,940 — (a) Includes shares of common stock surrendered to the Company to satisfy tax withholding obligations in connection with the vesting of awards under our long-term incentive program.
Equity Compensation Plan Information Information required by this item will be contained in our 2024 Proxy Statement under the heading “Items to be Voted Upon—Item 2—Advisory Vote to Approve the Compensation of our Named Executive Officers—Equity Compensation Plan Information,” which information is incorporated herein by reference.
Equity Compensation Plan Information Information required by this item will be contained in our 2025 Proxy Statement under the heading “Items to be Voted Upon—Item 2—Advisory Vote to Approve the Compensation of our Named Executive Officers—Equity Compensation Plan Information,” which information is incorporated herein by reference.
The graph assumes $100 investment on December 31, 2018 in each of our common shares, the S&P 500 Index and the stock of our peer group companies, including reinvestment of dividends, for the years ended December 31, 2019, 2020, 2021, 2022 and 2023.
The graph assumes $100 investment on December 31, 2019 in each of our common shares, the S&P 500 Index and the stock of our peer group companies, including reinvestment of dividends, for the years ended December 31, 2020, 2021, 2022, 2023 and 2024.
Item 5. MARKET FOR THE REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES. Bristol Myers Squibb common stock is traded on the New York Stock Exchange (Symbol: BMY). Holders of Common Stock The number of record holders of our common stock at January 31, 2024 was 31,207.
Item 5. MARKET FOR THE REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES. Bristol Myers Squibb common stock is traded on the New York Stock Exchange (Symbol: BMY). Holders of Common Stock The number of record holders of our common stock at January 31, 2025 was 29,685.
The remaining share repurchase capacity under the program was $5.0 billion as of December 31, 2023. Refer to “Item 8. Financial Statements and Supplementary Data—Note 17. Equity” for information on the share repurchase program. (c) Represents approximately 14 million of shares, under the ASR, settled and transferred into treasury stock.
The remaining share repurchase capacity under the program was $5.0 billion as of December 31, 2024. Refer to “Item 8. Financial Statements and Supplementary Data—Note 17. Equity” for information on the share repurchase program. Item 6. [RESERVED] 39
Removed
The completed repurchases pursuant to the ASR had an average repurchase price of $57.19. Refer to “Item 8. Financial Statements and Supplementary Data—Note 17. Equity” for further information. Item 6. [RESERVED] 37

Item 6. [Reserved]

Selected Financial Data — reserved (removed by SEC in 2021)

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Biggest changeItem 6. [Reserved] 37 Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations 38 Item 7A. Quantitative and Qualitative Disclosures About Market Risk 69 Item 8. Financial Statements and Supplementary Data 71 Consolidated Statements of Earnings and Comprehensive Income 71 Consolidated Balance Sheets 72 Consolidated Statements of Cash Flows 73 Notes to the Financial Statements 74
Biggest changeItem 6. [Reserved] 39 Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations 40 Item 7A. Quantitative and Qualitative Disclosures About Market Risk 73 Item 8. Financial Statements and Supplementary Data 75 Consolidated Statements of Earnings and Comprehensive (Loss)/Income 75 Consolidated Balance Sheets 76 Consolidated Statements of Cash Flows 77 Notes to the Financial Statements 78

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

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Biggest changeWe encourage investors to review our financial statements and publicly-filed reports in their entirety and not to rely on any single financial measure. 55 Specified items were as follows: Year Ended December 31, Dollars in millions 2023 2022 Inventory purchase price accounting adjustments $ 84 $ 293 Intangible asset impairment 27 — Site exit and other costs 64 63 Cost of products sold 175 356 Employee compensation charges — 73 Site exit and other costs 94 6 Marketing, selling and administrative 94 79 IPRD impairments 80 98 Priority review voucher 95 — Inventory purchase price accounting adjustments — 130 Employee compensation charges — 80 Site exit and other costs 12 — Research and development 187 308 Amortization of acquired intangible assets 9,047 9,595 Interest expense (a) (52) (83) Equity investment losses/(gains), net 152 799 Integration expenses 242 440 Loss on debt redemption — 266 Divestiture gains — (211) Litigation and other settlements (397) 140 Provision for restructuring 365 75 Other 55 71 Other (income)/expense, net 365 1,497 Increase to pretax income 9,868 11,835 Income taxes on items above (1,639) (1,332) Income taxes attributed to internal transfer of intangible and other assets — (72) Income tax reserve release attributed to Mead Johnson — (225) Income taxes attributed to non-U.S. tax ruling (656) — Income taxes (2,295) (1,629) Increase to net earnings $ 7,573 $ 10,206 (a) Includes amortization of purchase price adjustments to Celgene debt. 56 The reconciliations from GAAP to Non-GAAP were as follows: Year Ended December 31, Dollars in millions, except per share data 2023 2022 Net earnings attributable to BMS GAAP $ 8,025 $ 6,327 Specified Items 7,573 10,206 Non-GAAP $ 15,598 $ 16,533 Weighted-average common shares outstanding – diluted 2,078 2,146 Diluted earnings per share attributable to BMS GAAP $ 3.86 $ 2.95 Specified items 3.65 4.75 Non-GAAP $ 7.51 $ 7.70 57 Financial Position, Liquidity and Capital Resources Our net debt position was as follows: December 31, Dollars in millions 2023 2022 Cash and cash equivalents $ 11,464 $ 9,123 Marketable debt securities – current 816 130 Marketable debt securities – non-current 364 — Total cash, cash equivalents and marketable debt securities 12,644 9,253 Short-term debt obligations (3,119) (4,264) Long-term debt (36,653) (35,056) Net debt position $ (27,128) $ (30,067) Liquidity and Capital Resources We regularly assess our anticipated working capital needs, debt and leverage ratio levels, debt maturities, capital expenditure requirements, dividend payouts, potential share repurchases and future investments or acquisitions in order to maximize shareholder return, efficiently finance our ongoing operations and maintain flexibility for future strategic transactions.
Biggest change(b) Includes amortization of purchase price adjustments to Celgene debt. 59 The reconciliations from GAAP to Non-GAAP were as follows: Year Ended December 31, Dollars in millions, except per share data 2024 2023 Net (loss)/earnings attributable to BMS GAAP $ (8,948) $ 8,025 Specified Items 11,288 7,573 Non-GAAP $ 2,340 $ 15,598 Weighted-average common shares outstanding – diluted – GAAP 2,027 2,078 Incremental shares attributable to share-based compensation plans 5 — Weighted-average common shares outstanding – diluted – Non-GAAP 2,032 2,078 Diluted (loss)/earnings per share attributable to BMS GAAP $ (4.41) $ 3.86 Specified items 5.56 3.65 Non-GAAP $ 1.15 $ 7.51 60 Financial Position, Liquidity and Capital Resources Our net debt position was as follows: December 31, Dollars in millions 2024 2023 Cash and cash equivalents $ 10,346 $ 11,464 Marketable debt securities – current 513 816 Marketable debt securities – non-current 320 364 Total 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) Liquidity and Capital Resources We regularly assess our anticipated working capital needs, debt and leverage ratio levels, debt maturities, capital expenditure requirements, dividend payouts, potential share repurchases and future investments or acquisitions in order to maximize shareholder return, efficiently finance our ongoing operations and maintain flexibility for future strategic transactions.
Metastatic Colorectal Cancer January 2024 Announced that the Phase III CheckMate -8HW trial evaluating Opdivo plus Yervoy compared to investigator’s choice of chemotherapy as a first-line treatment for patients with microsatellite instability-high or mismatch repair deficient metastatic colorectal cancer met the dual primary endpoint of progression-free survival (PFS) as assessed by Blinded Independent Central Review (BICR) at a pre-specific interim analysis.
January 2024 Announced that the Phase III CheckMate -8HW trial evaluating Opdivo plus Yervoy compared to investigator’s choice of chemotherapy as a first-line treatment for patients with microsatellite instability-high or mismatch repair deficient metastatic colorectal cancer met the dual primary endpoint of progression-free survival (PFS) as assessed by Blinded Independent Central Review (BICR) at a pre-specific interim analysis.
These models required the use of the following significant estimates and assumptions among others: • Identification of product candidates with sufficient substance requiring separate recognition; • Estimates of revenues and operating profits related to commercial products or product candidates; • Eligible patients, pricing and market share used in estimating future revenues; • Probability of success for unapproved product candidates and additional indications for commercial products; • Resources required to complete the development and approval of product candidates; • Timing of regulatory approvals and exclusivity; • Appropriate discount rate by products; • Market participant income tax rates; and • Allocation of expected synergies to products.
These models required the use of the following significant estimates and assumptions among others: 65 • Identification of product candidates with sufficient substance requiring separate recognition; • Estimates of revenues and operating profits related to commercial products or product candidates; • Eligible patients, pricing and market share used in estimating future revenues; • Probability of success for unapproved product candidates and additional indications for commercial products; • Resources required to complete the development and approval of product candidates; • Timing of regulatory approvals and exclusivity; • Appropriate discount rate by products; • Market participant income tax rates; and • Allocation of expected synergies to products.
The estimated amount of unpaid or unbilled rebates and discounts is presented as a liability. Other rebates, returns, discounts and adjustments Other GTN sales adjustments include sales returns and all other programs based on applicable laws and regulations for individual non-U.S. countries as well as rebates offered to managed healthcare organizations in the U.S. to a lesser extent.
The estimated amount of unpaid or unbilled rebates and discounts is presented as a liability. 64 Other rebates, returns, discounts and adjustments Other GTN sales adjustments include sales returns and all other programs based on applicable laws and regulations for individual non-U.S. countries as well as rebates offered to managed healthcare organizations in the U.S. to a lesser extent.
Income Taxes.” Contingencies In the normal course of business, we are subject to contingencies, such as legal proceedings and claims arising out of our business, that cover a wide range of matters, including, among others, government investigations, shareholder lawsuits, product and environmental liability, contractual claims and tax matters.
Income Taxes.” 66 Contingencies In the normal course of business, we are subject to contingencies, such as legal proceedings and claims arising out of our business, that cover a wide range of matters, including, among others, government investigations, shareholder lawsuits, product and environmental liability, contractual claims and tax matters.
Similar charges or gains were recognized in prior periods and will likely reoccur in future periods, including (i) 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, (ii) unwind of inventory purchase price adjustments, (iii) acquisition and integration expenses, (iv) restructuring costs, (v) accelerated depreciation and impairment of property, plant and equipment and intangible assets, (vi) costs of acquiring a priority review voucher, (vii) divestiture gains or losses, (viii) stock compensation resulting from acquisition-related equity awards, (ix) pension, legal and other contractual settlement charges, (x) equity investment and contingent value rights fair value adjustments (including fair value adjustments attributed to limited partnership equity method investments), (xi) income resulting from the change in control of the Nimbus Therapeutics TYK2 Program and (xii) amortization of fair value adjustments of debt acquired from Celgene in our 2019 exchange offer, among other items.
Similar charges or gains were recognized in prior periods and will likely reoccur in future periods, including (i) 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, (ii) unwinding of inventory purchase price adjustments, (iii) acquisition and integration expenses, (iv) restructuring costs, (v) accelerated depreciation and impairment of property, plant and equipment and intangible assets, (vi) costs of acquiring a priority review voucher, (vii) divestiture gains or losses, (viii) stock compensation resulting from acquisition-related equity awards, (ix) pension, legal and other contractual settlement charges, (x) equity investment and contingent value rights fair value adjustments (including fair value adjustments attributed to limited partnership equity method investments), (xi) income resulting from the change in control of the Nimbus TYK2 Program and (xii) amortization of fair value adjustments of debt acquired from Celgene in our 2019 exchange offer, among other items.
We continue to evaluate the impact of the IRA legislation on our results of operations and it is possible that these changes may result in a material impact on our business and results of operations.
We continue to evaluate the impact of the IRA on our results of operations, and it is possible that these changes may result in a material impact on our business and results of operations.
EXECUTIVE SUMMARY Bristol-Myers Squibb Company is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. Refer to the Summary of Abbreviated Terms at the end of this 2023 Form 10-K for definitions of capitalized terms used throughout the document.
EXECUTIVE SUMMARY Bristol-Myers Squibb Company is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. Refer to the Summary of Abbreviated Terms at the end of this 2024 Form 10-K for definitions of capitalized terms used throughout the document.
Refer to “Item 8. Financial Statements and Supplementary Data—Note 7. Income Taxes” for additional information. In December 2022, the EU member states voted unanimously to adopt a Directive implementing the Pillar Two (global minimum tax) rules giving member states until December 31, 2023 to implement the Directive into national legislation.
Federal income tax return. Refer to “Item 8. Financial Statements and Supplementary Data—Note 7. Income Taxes” for additional information. In December 2022, the EU member states unanimously voted to adopt a Directive implementing the Pillar Two (global minimum tax) rules giving member states until December 31, 2023 to implement the Directive into national legislation.
In the U.S., we generally determine our months on hand estimates using inventory levels of product on hand and the amount of out-movement provided by our three largest wholesalers, which account for approximately 85% of total gross sales of U.S. products for the year ended December 31, 2023.
In the U.S., we generally determine our months on hand estimates using inventory levels of product on hand and the amount of out-movement provided by our three largest wholesalers, which account for approximately 85% of total gross sales of U.S. products for the year ended December 31, 2024.
Management’s discussion and analysis of financial condition and results of operations is provided as a supplement to and should be read in conjunction with the consolidated financial statements and related notes included elsewhere in this 2023 Form 10-K to enhance the understanding of our results of operations, financial condition and cash flows.
Management’s discussion and analysis of financial condition and results of operations is provided as a supplement to and should be read in conjunction with the consolidated financial statements and related notes included elsewhere in this 2024 Form 10-K to enhance the understanding of our results of operations, financial condition and cash flows.
We disclose products with levels of inventory in excess of one month on hand or expected demand, subject to certain limited exceptions. There were none as of December 31, 2023, for our U.S. distribution channels, and September 30, 2023, for our non-U.S. distribution channels.
We disclose products with levels of inventory in excess of one month on hand or expected demand, subject to certain limited exceptions. There were none as of December 31, 2024, for our U.S. distribution channels, and September 30, 2024, for our non-U.S. distribution channels.
No forward-looking statement can be guaranteed. We have included important factors in the cautionary statements included in this 2023 Form 10-K, particularly under “Item 1A. Risk Factors,” that we believe could cause actual results to differ materially from any forward-looking statement.
No forward-looking statement can be guaranteed. We have included important factors in the cautionary statements included in this 2024 Form 10-K, particularly under “Item 1A. Risk Factors,” that we believe could cause actual results to differ materially from any forward-looking statement.
Except as otherwise required by applicable law, we undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise after the date of this 2023 Form 10-K.
Except as otherwise required by applicable law, we undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise after the date of this 2024 Form 10-K.
As such, all of the information required to estimate months on hand in the direct customer distribution channel for non-U.S. business for the year ended December 31, 2023 is not available prior to the filing of this 2023 Form 10-K.
As such, all of the information required to estimate months on hand in the direct customer distribution channel for non-U.S. business for the year ended December 31, 2024 is not available prior to the filing of this 2024 Form 10-K.
Impairment and Amortization of Long-lived Assets, including Intangible Assets Long-lived assets include intangible assets and property, plant and equipment and are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of the assets may not be recoverable or at least annually for IPRD.
Impairment and Amortization of Long-lived Assets, including Goodwill and Other Intangible Assets Long-lived assets include intangible assets and property, plant and equipment and are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of the assets may not be recoverable or at least annually for Goodwill and IPRD.
January 2024 Announced four-year follow-up results from the CheckMate -9ER trial evaluating Opdivo in combination with Cabometyx* (cabozantinib) vs. sunitinib in patients with previously untreated advanced or metastatic RCC continued to show superior progression-free survival and objective response rates in patients treated with Opdivo plus Cabometyx* over sunitinib, regardless of risk classification based on IMDC scores.
Renal Cell Carcinoma January 2024 Announced four-year follow-up results from the CheckMate -9ER trial evaluating Opdivo in combination with Cabometyx * (cabozantinib) vs. sunitinib in patients with previously untreated advanced or metastatic RCC continued to show superior progression-free survival and objective response rates in patients treated with Opdivo plus Cabometyx * over sunitinib, regardless of risk classification based on IMDC scores.
In addition, data from the Phase III CheckMate -8HW trial showed that the combination of Opdivo plus Yervoy reduced the risk of disease progression or death by 79% versus chemotherapy as a first-line treatment for patients with microsatellite instability–high or mismatch repair deficient metastatic colorectal cancer (MSI-H/dMMR mCRC) compared to chemotherapy.
In addition, data from the Phase III CheckMate -8HW trial showed that the combination of Opdivo plus Yervoy reduced the risk of disease progression or death by 79% versus chemotherapy as a first-line treatment for patients with microsatellite instability–high or mismatch repair deficient metastatic colorectal cancer (MSIH/dMMR mCRC) compared to chemotherapy.
We believe that driving long-term business value is at the heart of living our purpose, enabling us to be leaders and difference-makers for generations to come. Acquisitions, Divestitures, Licensing and Other Arrangements For detailed information on significant acquisitions, divestitures, collaborations, licensing and other arrangements during 2023 refer to “Item 8. Financial Statements and Supplementary Data —Note 3.
We believe that driving long-term business value is at the heart of living our purpose, enabling us to be leaders and difference-makers for generations to come. 44 Acquisitions, Divestitures, Licensing and Other Arrangements For detailed information on significant acquisitions, divestitures, collaborations, licensing and other arrangements during 2024 refer to “Item 8. Financial Statements and Supplementary Data —Note 3.
Additional risks that we may currently deem immaterial or that are not presently known to us could also cause the forward-looking events discussed in this 2023 Form 10-K not to occur.
Additional risks that we may currently deem immaterial or that are not presently known to us could also cause the forward-looking events discussed in this 2024 Form 10-K not to occur.
Expectations of future cash flows are subject to change based upon the near and long-term production volumes and margins generated by the asset as well as any potential alternative future use. The estimated useful lives of long-lived assets is subjective and requires significant judgment regarding patent lives, future plans and external market factors.
Expectations of future cash flows are subject to change based upon the near and long-term production volumes and margins generated by the asset as well as any potential alternative future use. The estimated useful lives of long-lived assets are subjective and require significant judgment regarding patent lives, future plans and external market factors.
Cost of products sold also includes royalties and profit sharing, foreign currency hedge settlement gains and losses and impairment charges, as well as proportionate allocations of enterprise-wide costs. The allocations include facilities, information technology, employee stock compensation costs and other appropriate costs. Cost of products sold excludes amortization from acquired intangible assets.
Cost of products sold also includes royalties and profit sharing, foreign currency hedge settlement gains and losses and impairment charges, as well as proportionate allocations of enterprise-wide costs. The allocations include facilities, information technology and other appropriate costs. Cost of products sold excludes amortization from acquired intangible assets.
The reductions to provisions in 2022 driven by the non-U.S. revisions in clawback amounts driven by the VAT recoverable estimates. GTN adjustments are primarily a function of product sales volume, regional and payer channel mix, contractual or legislative discounts and rebates. U.S. GTN adjustments percentage increased primarily due to higher government channel mix, which has higher GTN adjustment percentages. Non-U.S.
The reductions to provisions in both years were driven by the non-U.S. revisions in clawback amounts driven by VAT recoverable estimates. GTN adjustments are primarily a function of product sales volume, regional and payer channel mix, contractual or legislative discounts and rebates. U.S. GTN adjustments percentage increased primarily due to higher government channel mix, which has higher GTN adjustment percentages.
Marketing, selling and administrative Marketing, selling and administrative expenses primarily include salary and benefit costs, third-party professional and marketing fees, outsourcing fees, shipping and handling costs, advertising and product promotion costs, as well as proportionate allocations of enterprise-wide costs. The allocations include facilities, information technology, employee stock compensation costs and other appropriate costs.
Marketing, selling and administrative Marketing, selling and administrative expenses primarily include salary and benefit costs, third-party professional and marketing fees, outsourcing fees, shipping and handling costs, advertising and product promotion costs, as well as proportionate allocations of enterprise-wide costs. The allocations include facilities, information technology, and other appropriate costs.
We believe that our existing cash, cash equivalents and marketable debt securities together with cash generated from operations in the next few years, and, if required, from the issuance of commercial paper, will be sufficient to satisfy our anticipated cash needs for at least the next few years, including dividends, capital expenditures, milestone payments, working capital, income taxes, restructuring initiatives, repurchase of common stock, and debt maturities of approximately $10.3 billion through 2028, as well as any debt repurchases through redemptions or tender offers.
We believe that our existing cash, cash equivalents and marketable debt securities together with cash generated from operations in the next few years, and, if required, from the issuance of commercial paper, will be sufficient to satisfy our anticipated cash needs for at least the next few years, including dividends, capital expenditures, milestone payments, working capital, income taxes, restructuring initiatives, repurchase of common stock, and debt maturities of approximately $14.0 billion through 2029, as well as any debt repurchases through redemptions or tender offers.
Refer to “—Product and Pipeline Developments” for all of the developments in our marketed products and late-stage pipeline in 2023 and in early 2024. 40 Strategy Our principal strategy is to combine the resources, scale and capability of a large pharmaceutical company with the speed, agility and focus on innovation typically found in the biotech industry.
Refer to “—Product and Pipeline Developments” for all of the developments in our marketed products and late-stage pipeline in 2024 and in early 2025. 43 Strategy Our principal strategy is to combine the resources, scale and capability of a large pharmaceutical company with the speed, agility and focus on innovation typically found in the biotech industry.
Payments generally are due and payable only upon achievement of certain developmental and regulatory milestones for which the specific timing cannot be predicted. Certain agreements also provide for sales-based milestones aggregating to $14.6 billion that we would be obligated to pay upon achievement of certain sales levels in addition to royalties.
Payments generally are due and payable only upon achievement of certain developmental and regulatory milestones for which the specific timing cannot be predicted. Certain agreements also provide for sales-based milestones aggregating to $16.2 billion that we would be obligated to pay upon achievement of certain sales levels in addition to royalties.
The comparison of 2022 to 2021 results has been omitted from this Form 10-K and is incorporated by reference from our Form 10-K for the year ended December 31, 2022 “Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations” filed on February 14, 2023.
The comparison of 2023 to 2022 results has been omitted from this Form 10-K and is incorporated by reference from our Form 10-K for the year ended December 31, 2023 “Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations” filed on February 13, 2024.
Non-GAAP information is intended to portray the results of our baseline performance, supplement or enhance management, analysts and investors’ overall understanding of our underlying financial performance and facilitate comparisons among current, past and future periods.
Non-GAAP information is intended to portray the results of our baseline performance, supplement or enhance management's, analysts' and investors’ overall understanding of our underlying financial performance and facilitate comparisons among current, past and future periods.
Additionally, in connection with the IRA the following changes have been made to U.S. tax laws, including (i) a 15% minimum tax that generally applies to U.S. corporations on adjusted financial statement income beginning in 2023 and (ii) a non-deductible 1% excise tax provision on net stock repurchases, to be applied to repurchases beginning in 2023.
Additionally, in connection with the IRA, the following changes have been made to U.S. tax laws, including (i) a 15% minimum tax that generally applies to U.S. corporations on adjusted financial statement income beginning in 2023 and (ii) a non-deductible 1% excise tax provision on net stock repurchases after December 31, 2022.
The allocations include facilities, information technology, employee stock compensation costs and other appropriate costs. Certain expenses are shared with alliance partners based upon contractual agreements.
The allocations include facilities, information technology, and other appropriate costs. Certain expenses are shared with alliance partners based upon contractual agreements.
Long-lived assets are also periodically reviewed for changes in facts or circumstances resulting in a reduction to the estimated useful life of the asset, requiring the acceleration of depreciation or amortization. Impairment charges included in Cost of products sold and Research and development expense were $136 million in 2023, $101 million in 2022 and $1.2 billion in 2021.
Long-lived assets are also periodically reviewed for changes in facts or circumstances resulting in a reduction to the estimated useful life of the asset, requiring the acceleration of depreciation or amortization. Impairment charges included in Cost of products sold, Research and development, and Other (income)/expense, net were $2.9 billion in 2024, $136 million in 2023 and $101 million in 2022.
These carryforwards were acquired as a result of certain acquisitions and are subject to limitations under Section 382 of the Internal Revenue Code. The net operating loss carryforwards expire in varying amounts beginning in 2024.
These carryforwards were acquired as a result of certain acquisitions and are subject to limitations under Section 382 of the Internal Revenue Code. The net operating loss carryforwards expire in varying amounts beginning in 2024. The foreign and state net operating loss carryforwards expire in varying amounts beginning in 2024 (certain amounts have unlimited lives).
Capital Expenditures Annual capital expenditures were approximately $1.1 billion in 2023 and 2022, $970 million in 2021 and are expected to be approximately $1.4 billion in 2024 and 2025. We continue to make capital expenditures in connection with the expansion of our cell therapy and other manufacturing capabilities, research and development and other facility-related activities.
Capital Expenditures Annual capital expenditures were approximately $1.2 billion in 2024, $1.1 billion in 2023 and 2022 and are expected to be approximately $1.5 billion in 2025. We continue to make capital expenditures in connection with the expansion of our cell therapy and other manufacturing capabilities, research and development and other facility-related activities.
Reconciliations of these non-GAAP measures to the most comparable GAAP measures are included in Exhibit 99.1 to our Form 8-K filed on February 2, 2024 and are incorporated herein by reference.
Reconciliations of these non-GAAP financial measures to the most comparable GAAP measures are included in Exhibit 99.1 to our Form 8-K filed on February 6, 2025 and are incorporated herein by reference.
In December 2023, the Board of Directors approved an increase of $3.0 billion to the share repurchase authorization for BMS's common stock. The remaining share repurchase capacity under the BMS share repurchase program was $5.0 billion as of December 31, 2023. Refer to “Item 8. Financial Statements and Supplementary Data—Note 17. Equity” for additional information.
In December 2023, the Board of Directors approved an increase of $3.0 billion to the share repurchase authorization for BMS's common stock. The remaining share repurchase capacity under the BMS share repurchase program was $5.0 billion as of December 31, 2024. There were no share repurchases in 2024. Refer to “Item 8. Financial Statements and Supplementary Data—Note 17.
We account for business combinations using the acquisition method of accounting, which requires that assets acquired and liabilities assumed generally be recorded at their fair values as of the acquisition date. Excess of consideration over the fair value of net assets acquired is recorded as goodwill.
We account for business combinations using the acquisition method of accounting, which requires that assets acquired and liabilities assumed generally be recorded at their fair values as of the acquisition date. Excess of consideration over the fair value of net assets acquired is recorded as goodwill. Estimating fair value requires us to make significant judgments and assumptions.
Pomalyst/Imnovid is indicated for patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy. • U.S. revenues decreased 3% in 2023 due to an increase in the number of patients receiving free drug product from the Bristol Myers Squibb Patient Assistance Foundation, a separate and independent 501(c)(3) entity to which BMS donates products, partially offset by higher average net selling prices. • International revenues increased 2% in 2023 due to higher demand, partially offset by lower average net selling prices and foreign exchange impacts of 1%.
Pomalyst/Imnovid is indicated for patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy. • U.S. revenues increased 15% in 2024 primarily due to the prior year impact of patients receiving free drug product from the Bristol Myers Squibb Patient Assistance Foundation, a separate and independent 501(c)(3) entity to which BMS donates products, and higher demand. • International revenues decreased 23% in 2024 primarily due to lower demand driven by generic erosion, lower average net selling prices and foreign exchange impacts of 1%.
The Opdivo + Yervoy regimen is approved in multiple markets for the treatment of NSCLC, melanoma, MPM, RCC, CRC and esophageal cancer. • U.S. revenues increased 6% in 2023 due to higher average net selling prices and demand. • International revenues increased 3% in 2023 due to higher demand as a result of additional indication launches and core indications, partially offset by lower average net selling prices and foreign exchange impacts of 2%.
The Opdivo + Yervoy regimen is approved in multiple markets for the treatment of NSCLC, melanoma, MPM, RCC, CRC and esophageal cancer. • U.S. revenues increased 16% in 2024 primarily due to higher demand and higher average net selling prices. • International revenues increased 8% in 2024 primarily due to higher demand as a result of additional indication launches and core indications, partially offset by foreign exchange impacts of 7%.
Sprycel (dasatinib) — an oral inhibitor of multiple tyrosine kinase indicated for the first-line treatment of patients with Philadelphia chromosome-positive CML in chronic phase and the treatment of adults with chronic, accelerated, or myeloid or lymphoid blast phase CML with resistance or intolerance to prior therapy, including Gleevec* (imatinib mesylate) and the treatment of children and adolescents aged 1 year to 18 years with chronic phase Philadelphia chromosome-positive CML. • U.S. revenues decreased 3% in 2023 due to lower average net selling prices driven by unfavorable GTN adjustments. • International revenues decreased 28% in 2023 due to lower demand as a result of generic erosion, lower average net selling price and foreign exchange impact of 3%.
Sprycel (dasatinib) — an oral inhibitor of multiple tyrosine kinase indicated for the first-line treatment of patients with Philadelphia chromosome-positive CML in chronic phase and the treatment of adults with chronic, accelerated, or myeloid or lymphoid blast phase CML with resistance or intolerance to prior therapy, including Gleevec* (imatinib mesylate) and the treatment of children and adolescents aged 1 year to 18 years with chronic phase Philadelphia chromosome-positive CML. • U.S. revenues decreased 31% in 2024 primarily due to lower average net selling prices and lower demand driven by generic erosion. • International revenues decreased 40% in 2024 primarily due to lower demand driven by generic erosion, lower average net selling prices and foreign exchange impact of 4%.
Excluding the impact of specified items, the effective tax rate decreased from 15.3% to 14.7% primarily due to (i) revised guidance regarding deductibility of certain research and development expenses which reduced income taxes attributable to 2023 pre-tax income by approximately $160 million and was the primary reason for a $240 million reduction to previously estimated income taxes for 2022 upon finalization of the U.S.
Excluding the impact of specified items, the effective tax rate was impacted by revised guidance regarding deductibility of certain research and development expenses which reduced income taxes attributable to 2023 pre-tax income by approximately $160 million and was the primary reason for a $240 million reduction to previously estimated income taxes for 2022 upon finalization of the U.S.
(a) Excludes amortization of acquired intangible assets. Cost of products sold Cost of products sold include material, internal labor and overhead costs from our owned manufacturing sites, third-party product supply costs and other supply chain costs managed by our global manufacturing and supply organization.
Cost of products sold Cost of products sold include material, internal labor and overhead costs from our owned manufacturing sites, third-party product supply costs and other supply chain costs managed by our global manufacturing and supply organization.
Reblozyl (luspatercept-aamt) — an erythroid maturation agent indicated for the treatment of anemia in i) adult patients with transfusion dependent and non-transfusion dependent beta thalassemia who require regular red blood cell transfusions, ii) adult patients with very low- to intermediate-risk MDS who have ring sideroblasts and require red blood cell transfusions, as well as iii) adult patients without previous erythropoiesis stimulating agent use (ESA-naïve) with very low- to intermediate-risk MDS who may require regular red blood cell transfusions, regardless of ring sideroblast status. • U.S. revenues increased 37% in 2023 primarily due to higher demand.
Reblozyl (luspatercept-aamt) — an erythroid maturation agent indicated for the treatment of anemia in (i) adult patients with transfusion dependent and non-transfusion dependent beta thalassemia who require regular red blood cell transfusions, (ii) adult patients with very low- to intermediate-risk MDS who have ring sideroblasts and require red blood cell transfusions, as well as (iii) adult patients without previous erythropoiesis stimulating agent use (ESA-naïve) with very low- to intermediate-risk MDS who may require regular red blood cell transfusions, regardless of RS status. • U.S. revenues increased 80% in 2024 primarily due to higher demand. • International revenues increased 61% in 2024 primarily due to higher demand, partially offset by foreign exchange impacts of 4%.
We are committed to an aggregate $20.0 billion of potential contingent future research and development milestone payments to third parties for in-licensing, asset acquisitions and development programs including early-stage milestones of $6.5 billion (milestones achieved through Phase III clinical studies) and late-stage milestones of $13.5 billion (milestones achieved post Phase III clinical studies).
We are committed to an aggregate $17.2 billion of potential contingent future research and development milestone payments to third parties for in-licensing, asset acquisitions and development programs including early-stage milestones of $5.8 billion (milestones achieved through Phase III clinical studies) and late-stage milestones of $11.4 billion (milestones achieved post Phase III clinical studies).
Revlimid has received approvals for several indications in the hematological malignancies including lymphoma and MDS. • U.S. revenues decreased 37% in 2023 primarily due to generic erosion and an increase in the number of patients receiving free drug product from the Bristol Myers Squibb Patient Assistance Foundation, a separate and independent 501(c)(3) entity to which BMS donates products, and to a lesser extent lower average net selling prices. • International revenues decreased 49% in 2023 primarily due to generic erosion across several European countries and foreign exchange impacts of 2%.
Revlimid has received approvals for several indications in the hematological malignancies including lymphoma and MDS. • U.S. revenues decreased 4% in 2024 primarily due to generic erosion and lower average net selling prices partially offset by the prior year impact of patients receiving free drug product from the Bristol Myers Squibb Patient Assistance Foundation, a separate and independent 501(c)(3) entity to which BMS donates products. • International revenues decreased 14% in 2024 primarily due to generic erosion across several European countries and foreign exchange impacts of 3%.
Together with our proven track record, rapidly advancing pipeline and growth with marketed products, we increased and sustained our R&D productivity enabling us to identify more high-quality candidates and increase their probability of reaching patients in need.
Together with our proven track record, rapidly advancing pipeline and increasing use of artificial intelligence, we are increasing our R&D productivity, enabling us to identify more high-quality candidates and increase their probability of reaching patients in need.
Dividend payments were $4.7 billion in 2023 and $4.6 billion in 2022. Dividend paid per common share was $0.57 during each quarter of 2023. Dividends are authorized on a quarterly basis by our Board of Directors.
Equity” for additional information. Dividend payments were $4.9 billion in 2024 and $4.7 billion in 2023. Dividend paid per common share was $0.60 during each quarter of 2024. Dividends are authorized on a quarterly basis by our Board of Directors.
Recently Issued Accounting Standards For recently issued accounting standards, refer to “Item 8. Financial Statements and Supplementary Data—Note 1. Accounting Policies and Recently Issued Accounting Standards.” SEC Consent Order As previously disclosed, on August 4, 2004, we entered into a final settlement with the SEC, concluding an investigation concerning certain wholesaler inventory and accounting matters.
Accounting Policies and Recently Issued Accounting Standards.” SEC Consent Order As previously disclosed, on August 4, 2004, we entered into a final settlement with the SEC, concluding an investigation concerning certain wholesaler inventory and accounting matters.
Our deferred tax assets were $7.3 billion at December 31, 2023 (net of valuation allowance of $764 million) and $4.1 billion at December 31, 2022 (net of valuation allowance of $873 million). The U.S. federal net operating loss carryforwards were $420 million at December 31, 2023.
Our deferred tax assets were $8.4 billion at December 31, 2024 (net of valuation allowance of $929 million) and $7.3 billion at December 31, 2023 (net of valuation allowance of $764 million). The U.S. federal net operating loss carryforwards were $2.0 billion at December 31, 2024.
Abecma (idecabtagene vicleucel) — is a BCMA genetically modified autologous CAR–T cell therapy indicated for the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-cyclic ADP ribose hydrolase monoclonal antibody. • U.S. revenues increased 21% in 2023 primarily due to higher demand enabled by additional manufacturing capacity.
Abecma (idecabtagene vicleucel) — is a BCMA genetically modified autologous CAR-T cell therapy indicated for the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-cyclic ADP ribose hydrolase monoclonal antibody. • U.S. revenues decreased 32% in 2024 primarily due to increased competition in BCMA targeted therapies. • International revenues increased 44% in 2024 due to higher demand partially offset by foreign exchange of 3%.
Furthermore, countries are expected to make changes to their tax laws and updates to international tax treaties to implement the agreement by the OECD to establish a global minimum tax. See risk factors on these items included under “Part I—Item 1A.
Furthermore, countries are in the process of enacting changes to their tax laws to implement the agreement by the OECD to establish a global minimum tax. See risk factors on these items included under “Part I—Item 1A.
Legal Proceedings and Contingencies—Intellectual Property” for further information. Opdivo (nivolumab) — a fully human monoclonal antibody that binds to the PD-1 on T and NKT cells. It has been approved for several anti-cancer indications including bladder, blood, CRC, head and neck, RCC, HCC, lung, melanoma, MPM, stomach and esophageal cancer.
(b) Includes other mature brands. 49 Growth Portfolio Opdivo (nivolumab) — a fully human monoclonal antibody that binds to the PD-1 on T and NKT cells. It has been approved for several anti-cancer indications including bladder, blood, CRC, head and neck, RCC, HCC, lung, melanoma, MPM, stomach and esophageal cancer.
There were no commercial paper borrowings outstanding as of December 31, 2023. 58 As of December 31, 2023, we had a five-year $5.0 billion revolving credit facility expiring in January 2028, which is extendable annually by one year with the consent of the lenders. In January 2024, we extended the credit facility to January 2029.
As of December 31, 2024, we had a five-year $5.0 billion revolving credit facility expiring in January 2029, which is extendable annually by one year with the consent of the lenders. In January 2025, we extended the credit facility to January 2030.
Excluding foreign exchange impacts, revenues decreased by 47%. • In the U.S., certain third parties have been granted volume-limited licenses to sell generic lenalidomide beginning in March 2022 or thereafter. Pursuant to these licenses, several generics have entered or are expected to enter the U.S. market with volume-limited quantities of generic lenalidomide.
Excluding foreign exchange impacts, revenues decreased 11%. • In the U.S., certain third parties have been granted volume-limited licenses to sell generic lenalidomide. Pursuant to these licenses, several generics have entered or are expected to enter the U.S. market with volume-limited quantities of generic lenalidomide. These licenses will no longer be volume limited beginning on January 31, 2026.
The settlement was reached through a Consent, a copy of which was attached as Exhibit 10 to our quarterly report on Form 10-Q for the period ended September 30, 2004. 60 Under the terms of the Consent, we agreed, subject to certain defined exceptions, to limit sales of all products sold to our direct customers (including wholesalers, distributors, hospitals, retail outlets, pharmacies and government purchasers) based on expected demand or on amounts that do not exceed approximately one month of inventory on hand, without making a timely public disclosure of any change in practice.
Under the terms of the Consent, we agreed, subject to certain defined exceptions, to limit sales of all products sold to our direct customers (including wholesalers, distributors, hospitals, retail outlets, pharmacies and government purchasers) based on expected demand or on amounts that do not exceed approximately one month of inventory on hand, without making a timely public disclosure of any change in practice.
Additionally, in February 2024, we entered into a $2.0 billion 364-day revolving credit facility. The facilities provide for customary terms and conditions with no financial covenants and may be used to provide backup liquidity for our commercial paper borrowings. No borrowings were outstanding under any revolving credit facility as of December 31, 2023 or 2022.
Additionally, in February 2024, we entered into a $2.0 billion 364-day revolving credit facility which expired in January 2025. The facilities provide for customary terms and conditions with no financial covenants and may be used to provide backup liquidity for our commercial paper borrowings.
We also provide international revenues for our priority products excluding the impact of foreign exchange. 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.
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.
Stable background use of antifibrotics in the IPF cohort and/or select immunosuppressives in the PPF cohort were allowed. 68 Special Note Regarding Forward-Looking Statements This 2023 Form 10-K (including documents incorporated by reference) and other written and oral statements we make from time to time contain certain “forward-looking” statements within the meaning of Section 27A of the Securities Act, and Section 21E of the Exchange Act.
Special Note Regarding Forward-Looking Statements This 2024 Form 10-K (including documents incorporated by reference) and other written and oral statements we make from time to time contain certain “forward-looking” statements within the meaning of Section 27A of the Securities Act, and Section 21E of the Exchange Act.
Abraxane (paclitaxel albumin-bound particles for injectable suspension) — a solvent-free protein-bound chemotherapy product that combines paclitaxel with albumin using our proprietary Nab ® technology platform, and is used to treat breast cancer, NSCLC and pancreatic cancer, among others. • U.S. revenues increased 22% in 2023 primarily due to higher branded sales resulting from lower authorized generic sales. 50 Estimated End-User Demand Pursuant to the SEC Consent Order described under “—SEC Consent Order”, we monitor inventory levels on hand in the U.S. wholesaler distribution channel and outside of the U.S. in the direct customer distribution channel.
In Japan, the composition of matter patent for the treatment of non-imatinib-resistant CML has expired. 52 Abraxane (paclitaxel albumin-bound particles for injectable suspension) — a solvent-free protein-bound chemotherapy product that combines paclitaxel with albumin using our proprietary Nab ® technology platform, and is used to treat breast cancer, NSCLC and pancreatic cancer, among others. • U.S. revenues decreased 23% in 2024 primarily due to lower demand driven by generic erosion. 53 Estimated End-User Demand Pursuant to the SEC Consent Order described under “—SEC Consent Order”, we monitor inventory levels on hand in the U.S. wholesaler distribution channel and outside of the U.S. in the direct customer distribution channel.
We will disclose any product with levels of inventory in excess of one month on hand or expected demand for the current quarter, subject to certain limited exceptions, in our next quarterly report on Form 10-Q. 51 Expenses Year Ended December 31, Dollar in Millions 2023 2022 % Change Cost of products sold (a) $ 10,693 $ 10,137 5 % Marketing, selling and administrative 7,772 7,814 (1) % Research and development 9,299 9,509 (2) % Acquired IPRD 913 815 12 % Amortization of acquired intangible assets 9,047 9,595 (6) % Other (income)/expense, net (1,158) 576 * Total Expenses $ 36,566 $ 38,446 (5) % * Change in excess of 100%.
We will disclose any product with levels of inventory in excess of one month on hand or expected demand for the current quarter, subject to certain limited exceptions, in our next quarterly report on Form 10-Q. 54 Expenses Year Ended December 31, Dollar in Millions 2024 2023 % Change Cost of products sold (a) $ 13,968 $ 10,693 31 % Marketing, selling and administrative 8,414 7,772 8 % Research and development 11,159 9,299 20 % Acquired IPRD 13,373 913 >200% Amortization of acquired intangible assets 8,872 9,047 (2) % Other (income)/expense, net 893 (1,158) (177) % Total Expenses $ 56,679 $ 36,566 55 % (a) Excludes amortization of acquired intangible assets.
Certain jurisdictions in which we operate, under the OECD/G20 Inclusive Framework, have enacted legislation that adopts a subset of such rules effective January 1, 2024, with the remaining rules becoming effective January 1, 2025. These rules and associated legislative changes may significantly impact our tax provision and results of operations.
Certain jurisdictions in which we operate, under the OECD/G20 Inclusive Framework, have enacted legislation that adopts a subset of such rules effective January 1, 2024, with the remaining rules becoming effective January 1, 2025.
For example, on August 16, 2022, President Biden signed the IRA into law which provides for (i) the government to negotiate prices for select high-cost Medicare Part D (beginning in 2026) and Part B drugs (beginning in 2028) that are more than nine years (for small-molecule drugs) or 13 years (for biological products) from their FDA approval, (ii) manufacturers to pay a rebate for Medicare Part B and Part D drugs when prices increase faster than inflation beginning in 2022 for Part D and 2023 for Part B, and (iii) Medicare Part D redesign which replaces the current Part D CGDP and establishes a $2,000 cap for out-of-pocket limits costs for Medicare beneficiaries beginning in 2025, with manufacturers being responsible for 10% of costs up to the $2,000 cap and 20% after that cap is reached.
The IRA directs (i) the federal government to “negotiate” prices for select high-cost Medicare Part D (beginning in 2026) and Part B (beginning in 2028) drugs that are more than nine years (for small-molecule drugs) or 13 years (for biological products) from their initial FDA approval, (ii) manufacturers to pay a rebate for Medicare Part B and Part D drugs when prices increase faster than inflation and (iii) the formation of the Part D Manufacturer Program which replaced the Part D CGDP and established a $2,000 cap for out-of-pocket costs for Medicare beneficiaries as of January 2025, with manufacturers being responsible for 10% of costs up to the $2,000 cap and 20% after that cap is reached.
June 2023 Announced four-year follow-up results from the Phase III CheckMate -9LA trial demonstrating durable, long-term survival benefits with Opdivo plus Yervoy with two cycles of chemotherapy compared to four cycles of chemotherapy alone in previously untreated patients with metastatic NSCLC.
NSCLC June 2024 Announced that the five-year follow-up results from the Phase III CheckMate -9LA trial showed durable, long-term survival benefits with Opdivo plus Yervoy combined with two cycles of chemotherapy compared to chemotherapy alone as a first-line treatment in patients with metastatic NSCLC.
Risk Factors—Product, Industry and Operational Risks—Increased pricing pressure and other restrictions in the U.S. and abroad continue to negatively affect our revenues and profit margins”, “—We could lose market exclusivity of a product earlier than expected” and “—Changes to tax regulations could negatively impact our earnings.” Significant Product Approvals The following is a summary of the significant approvals received in 2023: Product Date Approval Augtyro (repotrectinib) November 2023 FDA approval of Augtyro for the treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC. 39 Opdivo October 2023 FDA approval of Opdivo for the adjuvant treatment of adult and pediatric patients 12 years and older with completely resected stage IIB or IIC melanoma.
Risk Factors—Product, Industry and Operational Risks—Increased pricing pressure and other restrictions in the U.S. and abroad continue to negatively affect our revenues and profit margins”, “—We could lose market exclusivity of a product earlier than expected” and “—Changes to tax regulations could negatively impact our earnings.” 41 Significant Product Approvals The following is a summary of the significant approvals received: Product Date Approval Augtyro January 2025 EC approval for Augtyro as a treatment for adult patients with ROS1-positive NSCL and for adult and pediatric patients 12 years of age and older with NTRK-positive solid tumors.
The approval is based on the results of the global Phase III COMMANDS trial and the Phase III MEDALIST study, as well as a Japanese Phase II study (Study MDS-003) in red blood cell transfusion-independent low-risk MDS patients.
January 2024 Announced that Japan's Ministry of Health, Labour and Welfare granted manufacturing and marketing approval for Reblozyl for MDS-related anemia. The approval is based on the results of the global Phase III COMMANDS trial and the Phase III MEDALIST study, as well as a Japanese Phase II study (Study MDS-003) in red blood cell transfusion-independent low-risk MDS patients.
GTN Adjustments We recognize revenue net of GTN adjustments that are further described in “—Critical Accounting Policies.” The activities and ending reserve balances for each significant category of GTN adjustments were as follows: Dollars in millions Charge-Backs and Cash Discounts Medicaid and Medicare Rebates Other Rebates, Returns, Discounts and Adjustments Total Balance at January 1, 2023 $ 675 $ 3,822 $ 2,880 $ 7,377 Provision related to sales made in: Current period 9,155 13,400 7,480 30,035 Prior period (11) 11 (134) (134) Payments and returns (9,172) (12,788) (7,065) (29,025) Foreign currency translation and other (1) — 76 75 Balance at December 31, 2023 $ 646 $ 4,445 $ 3,237 $ 8,328 43 The reconciliation of gross product sales to net product sales by each significant category of GTN adjustments was as follows: Year Ended December 31, % Change Dollars in millions 2023 2022 2023 vs. 2022 Gross product sales $ 73,679 $ 69,633 6 % GTN Adjustments Charge-backs and cash discounts (9,144) (7,469) 22 % Medicaid and Medicare rebates (13,411) (11,362) 18 % Other rebates, returns, discounts and adjustments (7,346) (6,131) 20 % Total GTN Adjustments (29,901) (24,962) 20 % Net product sales $ 43,778 $ 44,671 (2) % GTN adjustments percentage 40 % 36 % 4 % U.S. 46 % 41 % 5 % Non-U.S. 19 % 17 % 2 % Reductions to provisions for product sales made in prior periods resulting from changes in estimates were $134 million for 2023 and $229 million for 2022, respectively.
GTN Adjustments We recognize revenue net of GTN adjustments that are further described in “—Critical Accounting Policies.” The activities and ending reserve balances for each significant category of GTN adjustments were as follows: Dollars in millions Charge-Backs and Cash Discounts Medicaid and Medicare Rebates Other Rebates, Returns, Discounts and Adjustments Total Balance at January 1, 2024 $ 646 $ 4,445 $ 3,237 $ 8,328 Provision related to sales made in: Current period 11,518 16,642 8,892 37,052 Prior period (8) (91) (60) (159) Payments and returns (11,254) (15,612) (8,287) (35,153) Foreign currency translation and other (2) 1 (146) (147) Balance at December 31, 2024 $ 900 $ 5,385 $ 3,636 $ 9,921 46 The reconciliation of gross product sales to net product sales by each significant category of GTN adjustments was as follows: Year Ended December 31, Dollars in millions 2024 2023 % Change Gross product sales $ 83,671 $ 73,679 14 % GTN Adjustments Charge-backs and cash discounts (11,510) (9,144) 26 % Medicaid and Medicare rebates (16,551) (13,411) 23 % Other rebates, returns, discounts and adjustments (8,832) (7,346) 20 % Total GTN Adjustments (36,893) (29,901) 23 % Net product sales $ 46,778 $ 43,778 7 % GTN adjustments percentage 44 % 40 % 4 % U.S. 49 % 46 % 3 % Non-U.S. 20 % 19 % 1 % Reductions to provisions for product sales made in prior periods resulting from changes in estimates were $159 million for 2024 and $134 million for 2023.
Collectively, the current long-term credit ratings reflect the agencies’ opinion that we have a low default risk but are somewhat susceptible to adverse effects of changes in circumstances and economic conditions. The short-term credit ratings reflect the agencies’ opinion that we have good to extremely strong capacity for timely repayment.
Our current long-term and short-term credit ratings assigned by Standard & Poor’s are A and A-1, respectively, with a stable long-term credit outlook. The long-term ratings reflect the agencies’ opinion that we have a low default risk but are somewhat susceptible to adverse effects of changes in circumstances and economic conditions.
The application is based on the results from the sub-study of the Phase III CheckMate -901 trial. December 2023 Announced that the FDA accepted the sBLA for Opdivo in combination with cisplatin-based chemotherapy as a first-line treatment for adult patients with unresectable or metastatic urothelial carcinoma. The application is based on results from the Phase III CheckMate -901 trial.
The approval is based on the results from the Phase III CheckMate -901 trial. May 2024 Announced EC approval of Opdivo in combination with cisplatin and gemcitabine for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma. The approval is based on the results from the Phase III CheckMate -901 trial.
Accounts receivable is reduced for the estimated amount of unprocessed charge-back claims attributable to a sale (typically within a two to four week time lag). 61 In the U.S. and certain other countries, customers are offered cash discounts as an incentive for prompt payment, generally approximating 2% of the invoiced sales price.
In the U.S. and some other countries, customers are offered cash discounts as an incentive for prompt payment on certain products, approximating 2% of the invoiced sales price. Accounts receivable is reduced for the estimated amount of cash discount at the time of sale and the discount is typically taken by the customer within one month.
Refer to “Item 8. Financial Statements and Supplementary Data—Note 10. Financing Arrangements” for further information. • Royalties increased in 2023 primarily due to higher Keytruda * royalties. Refer to “Item 8. Financial Statements and Supplementary Data—Note 4.
Refer to “Item 8. Financial Statements and Supplementary Data—Note 10. Financing Arrangements” for further information. • Royalty income decreased in 2024 primarily due to lower royalty rates for Keytruda * starting in 2024, partially offset by higher royalties from diabetes business divestitures in 2024. Refer to “Item 8. Financial Statements and Supplementary Data—Note 4.
Orencia (abatacept) — a fusion protein indicated for adult patients with moderate to severe active RA and PsA and is also indicated for reducing signs and symptoms in certain pediatric patients with moderately to severely active polyarticular JIA and for the treatment of aGVHD, in combination with a calcineurin inhibitor and methotrexate. • U.S. revenues increased 4% in 2023 primarily due to higher demand. • International revenues increased 3% in 2023 due to higher demand partially offset by foreign exchange impact of 3%.
It has indications for (i) reducing signs and symptoms in certain pediatric patients with moderately to severely active polyarticular JIA and (ii) for the treatment of aGVHD, in combination with a calcineurin inhibitor and methotrexate. • U.S. revenues increased 2% in 2024 primarily due to higher demand, partially offset by lower average net selling prices. • International revenues increased 2% in 2024 primarily due to higher demand, partially offset by foreign exchange impact of 8%.
Opdivo was the only investigational compound or marketed product that represented approximately 10% of our R&D expenses in the last three years. Our late-stage development programs could potentially have an impact on our revenue and earnings within the next few years if regulatory approvals are obtained and products are successfully commercialized.
Our late-stage development programs could potentially have an impact on our revenue and earnings within the next few years if regulatory approvals are obtained and products are successfully commercialized.
In August 2023, the U.S. Department of Health and Human Services selected Eliquis as one of the first 10 medicines subject to government-set prices beginning in 2026. It is possible that more of our products could be selected in future years, which could, among other things, accelerate revenue erosion prior to expiry of intellectual property protections.
In January 2025, the HHS selected Pomalyst as a medicine subject to "negotiation" for government-set prices beginning in 2027. It is possible that more of our products could be selected in future years, which could, among other things, accelerate revenue erosion prior to expiry of intellectual property protections.
Estimating fair value requires us to make significant judgments and assumptions. 62 In transactions accounted for as acquisitions of assets, no goodwill is recorded and contingent consideration, such as payments upon achievement of various developmental, regulatory and commercial milestones, generally is not recognized at the acquisition date.
In transactions accounted for as acquisitions of assets, no goodwill is recorded and contingent consideration, such as payments upon achievement of various developmental, regulatory and commercial milestones, generally is not recognized at the acquisition date. In an asset acquisition, upfront payments allocated to IPRD projects at the acquisition date are expensed unless there is an alternative future use.
The approval is based on the interim analysis from the Phase III KarMMa-3 study. April 2023 Announced with our alliance partner, 2seventy bio, that the FDA accepted the sBLA for Abecma for the treatment of adult patients with relapsed and refractory multiple myeloma who have received an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.
April 2024 Announced the FDA approval of Abecma for the treatment of adult patients with relapsed or refractory multiple myeloma after two or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody. The approval is based on results from the Phase III KarMMa-3 trial.
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, release of income tax reserves related to the Mead Johnson split-off transaction and internal transfers of intangible and other assets to streamline our legal entity structure subsequent to the Celgene acquisition.
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. We also provide international revenues for our priority products excluding the impact of foreign exchange.
Acquired IPRD charges are detailed in the table below. 52 Year Ended December 31, Dollars in millions 2023 2022 Mavacamten rights buy-out (Note 4) $ 445 $ — Orum upfront payment (Note 4) 100 — Mavacamten royalty extinguishment (Note 4) — 295 Dragonfly milestone and opt-in license fee — 200 Evotec designation and opt-in license fees 90 — BridgeBio upfront collaboration fee — 90 Prothena opt-in license fee 55 Zenas upfront license fee 50 — Immatics upfront license and opt-in fee (Note 4) 15 150 Other 158 80 Acquired IPRD $ 913 $ 815 Refer to “Item 8.
Acquired IPRD charges are detailed in the table below. 55 Year Ended December 31, Dollars in millions 2024 2023 Karuna asset acquisition (Note 4) $ 12,122 $ — SystImmune upfront fee (Note 3) 800 — LianBio mavacamten rights buy-out (Note 4) — 445 Evotec designation and opt-in license fees 170 90 Orum upfront payment (Note 4) — 100 RayzeBio rights buy-out 92 — Prothena opt-in license fee 80 55 Other 109 223 Acquired IPRD $ 13,373 $ 913 Refer to “Item 8.
We do not have any off-balance sheet arrangements that are material or reasonably likely to become material to our financial condition or results of operations. Credit Ratings In December 2023, following our announcements to acquire Karuna and RayzeBio, Standard & Poor's downgraded BMS's long-term credit rating to A from A+ (with a stable long-term credit outlook).
We do not have any off-balance sheet arrangements that are material or reasonably likely to become material to our financial condition or results of operations. Credit Ratings Our current long-term and short-term credit ratings assigned by Moody’s Investors Service are A2 and Prime-1, respectively, with a stable long-term credit outlook.
No single country outside the U.S. contributed more than 10% of total revenues in 2023 and 2022. Our business is typically not seasonal.
No single country outside the U.S. contributed more than 10% of total revenues in 2024 and 2023. Our business is typically not seasonal; however, in the first quarter we typically see an unwinding of sales channel inventory build-up from the fourth quarter of the prior year.
In an asset acquisition, upfront payments allocated to IPRD projects at the acquisition date are expensed unless there is an alternative future use. In addition, product development milestones are expensed upon achievement. We have identifiable intangible assets that are measured at their respective fair values as of the acquisition date.
In addition, product development milestones are expensed upon achievement. We have identifiable intangible assets that are measured at their respective fair values as of the acquisition date. Generally, we engage an independent third-party valuation firm to assist in determining the fair values of these assets as of the acquisition date.

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Item 7A. Quantitative and Qualitative Disclosures About Market Risk

Market Risk — interest-rate, FX, commodity exposure

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Biggest changeWe estimate that a 10% appreciation in the underlying currencies being hedged from their levels against the U.S. dollar (with all other variables held constant) would increase the fair value of cross-currency swap contracts by $46 million as of December 31, 2023 and decrease by $73 million as of December 31, 2022, respectively. For additional information, refer to “Item 8.
Biggest changeWe estimate that a 10% appreciation in the underlying currencies being hedged from their levels against the U.S. dollar (with all other variables held constant) would increase the fair value of cross-currency swap contracts by $49 million as of December 31, 2024 and increase by $46 million as of December 31, 2023, respectively. For additional information, refer to “Item 8.
All of our financial instruments, including derivatives, are subject to counterparty credit risk considered as part of the overall fair value measurement. Derivative financial instruments are not used for trading purposes. Foreign Exchange Risk Significant amounts of our revenues, earnings and cash flow are exposed to changes in foreign currency rates.
All of our financial instruments, including derivatives, are subject to counterparty credit risk considered as part of the overall fair value measurement. Derivative financial instruments are not used for trading purposes. 73 Foreign Exchange Risk Significant amounts of our revenues, earnings and cash flow are exposed to changes in foreign currency rates.
Financial Statements and Supplementary Data—Note 9. Financial Instruments and Fair Value Measurements.” 69 Interest Rate Risk We use fixed-to-floating interest rate swap contracts designated as fair value hedges to provide an appropriate balance of fixed and floating rate debt.
Financial Statements and Supplementary Data—Note 9. Financial Instruments and Fair Value Measurements.” Interest Rate Risk We use fixed-to-floating interest rate swap contracts designated as fair value hedges to provide an appropriate balance of fixed and floating rate debt.
We have a policy of diversifying derivatives with counterparties to mitigate the overall risk of counterparty defaults. For additional information, refer to “Item 8. Financial Statements and Supplementary Data—Note 9. Financial Instruments and Fair Value Measurements.” 70
We have a policy of diversifying derivatives with counterparties to mitigate the overall risk of counterparty defaults. For additional information, refer to “Item 8. Financial Statements and Supplementary Data—Note 9. Financial Instruments and Fair Value Measurements.” 74
In this sensitivity analysis, if there was a 1% increase in short-term or long-term interest rates as of December 31, 2023 and December 31, 2022, the expected adverse impact on our earnings would not be material.
In this sensitivity analysis, if there was a 1% increase in short-term or long-term interest rates as of December 31, 2024 and December 31, 2023, the expected adverse impact on our earnings would not be material.
Our primary net foreign currency translation exposures are the euro and Japanese yen. Foreign currency forward and purchased local currency put option contracts are used to manage risk primarily arising from certain intercompany sales and purchases transactions.
Our primary net foreign currency translation exposures are the euro and Japanese yen. Foreign currency forward and purchased local currency put option contracts are used to manage risk primarily arising from certain intercompany sales, third party sales and purchases transactions.
We estimate that an increase of 1% in long-term interest rates as of December 31, 2023 and December 31, 2022 would decrease the fair value of long-term debt by $3.0 billion and $2.6 billion, respectively. Credit Risk We monitor our investments with counterparties with the objective of minimizing concentrations of credit risk.
We estimate that an increase of 1% in long-term interest rates as of December 31, 2024 and December 31, 2023 would decrease the fair value of long-term debt by $3.6 billion and $3.0 billion, respectively. Credit Risk We monitor our investments with counterparties with the objective of minimizing concentrations of credit risk.
We estimate that a 10% appreciation in the underlying currencies being hedged from their levels against the U.S. dollar (with all other variables held constant) would decrease the fair value of foreign exchange contracts by $409 million and $782 million as of December 31, 2023 and December 31, 2022, respectively, reducing earnings over the remaining life of the contracts.
We estimate that a 10% appreciation in the underlying currencies being hedged from their levels against the U.S. dollar (with all other variables held constant) would decrease the fair value of foreign exchange contracts by $455 million and $409 million as of December 31, 2024 and December 31, 2023, respectively, reducing earnings over the remaining life of the contracts.

Other BMY 10-K year-over-year comparisons