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What changed in Bristol Myers Squibb's 10-K — 2022 vs 2023

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Paragraph-level year-over-year comparison of Bristol Myers Squibb's 2022 and 2023 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 2023 report.

+485 added−473 removedSource: 10-K (2024-02-13) vs 10-K (2023-02-14)

Top changes in Bristol Myers Squibb's 2023 10-K

485 paragraphs added · 473 removed · 326 edited across 8 sections

Item 1. Business

Business — how the company describes what it does

131 edited+23 added−26 removed149 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 Additional Indications OPDIVO --Hematologic Malignancies Investigational Compounds alnuctamab BCMA TCE --Relapsed/Refractory Multiple Myeloma Anti-SIRPα -- Hematologic Malignancies BCMA ADC^ --Relapsed/Refractory Multiple Myeloma BCMA NKE --Relapsed/Refractory Multiple Myeloma BET Inhibitor (CC-90010)^ --Hematologic Malignancies CD33 NKE --Relapsed/Refractory Multiple Myeloma CD47xCD20 --Non-Hodgkin's Lymphoma CK1α Degrader --Hematologic Malignancies GPRC5D CAR-T --Relapsed/Refractory Multiple Myeloma GSPT1 CELMoD (CC-90009)^ --Relapsed/Refractory Acute Myeloid Leukemia iberdomide^ --1L Diffuse Large B-cell Lymphoma --3L+ Follicular Lymphoma --Relapsed/Refractory Non-Hodgkin Lymphoma --Large B-cell Lymphoma Additional Indications ABECMA ª --1-4L+ Multiple Myeloma BREYANZI --3L+ Chronic Lymphocytic Leukemia --3L+ Follicular Lymphoma --3L+ Marginal Zone Lymphoma --3L+ Mantle Cell Lymphoma ONUREG --Low-to-Intermediate risk MDS OPDIVO ª + EMPLICITI ª --Relapsed/Refractory Multiple Myeloma REBLOZYL ª --A-Thalassemia SubQ IDHIFA --1L Acute Myeloid Leukemia Investigational Compounds A/I CELMoD (CC-99282)^ --Relapsed/Refractory Non-Hodgkin Lymphoma BET Inhibitor (BMS-986158) --Hematologic Malignancies iberdomide --Newly-Diagnosed Multiple Myeloma Additional Indications ABECMA ª --3-5L Multiple Myeloma INREBIC --MF Previously treated with Ruxolitinib REBLOZYL ª --1L TD MDS Associated Anemia --1L TD MF Associated Anemia Investigational Compounds iberdomide --2L+ Multiple Myeloma mezigdomide (CC-92480) --2L+ Multiple Myeloma ABECMA --5L+ Relapsed/Refractory Multiple Myeloma --4L+ Relapsed/Refractory 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 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 Additional Indications OPDIVO ª --Solid Tumors OPDIVO ª + YERVOY ª --Solid Tumors Investigational Compounds AHR Antagonist^ --Solid Tumors Anti-CCR8^ --Solid Tumors Anti-ILT4^ ª --Solid Tumors AR-LDD^ --Solid Tumors Anti-NKG2A^ --Solid Tumors Claudin 18.2 ADC ª --Advance Solid Tumors CD3xPSCA Bispecific --Solid Tumors DGK Inhibitor --Solid Tumors JNK Inhibitor --Solid Tumors LSD1 Inhibitor^ --Solid Tumors MAGE A4/8 TCER ª --Solid Tumors SHP2 Inhibitor ª ^ --Solid Tumors TGFβ Inhibitor^ --Solid Tumors TIGIT Bispecific ª --Solid Tumors Additional Indications OPDIVO ª --Solid Tumors --2L CRC --Pan Tumor TMB High OPDIVO ª + YERVOY ª --Solid Tumors --2L Metastatic Castration-Resistant Prostate Cancer OPDIVO ª + CDK4/6 Inhibitor --Neoadjuvant ER+/HER2- Breast nivolumab + relatlimab --1L Stage IV NSCLC --1L/2L Hepatocellular carcinoma Investigational Compounds Anti-CTLA-4 NF Probody Therapeutic --Solid Tumors Anti-Fucosyl GM1^ --Solid Tumors Anti-IL8^ --Solid Tumors Anti-TIGIT^ --Solid Tumors BET Inhibitor (CC-90010)^ --Solid Tumors farletuzumab-ecteribulin ª --Solid Tumors repotrectinib --ROS1 NSCLC --NTRK Pan Tumor Additional Indications OPDIVO ª --Peri-adjuvant Muscle Invasive Urothelial Carcinoma --Adjuvant Gastric Cancer --Adjuvant HCC --Adjuvant Melanoma --1L Metastatic Castration-Resistant Prostate Cancer --Peri-adjuvant NSCLC Stage IB-IIIA Adjuvant NSCLC # OPDIVO ª + YERVOY ª --1L Bladder Cancer --1L HCC --1L+ MSI-High CRC h --Adjuvant RCC --Stage III Unresectable NSCLC OPDUALAG (fixed dose nivolumab + relatlimab) ª --Adjuvant Melanoma --2L+ Microsatellite Stable Metastatic CRC --1L Melanoma SubQ Investigational Compounds subcutaneous nivolumab + rHuPH20 ª --2L RCC --Adjuvant Melanoma ABRAXANE --Breast --Gastric --Locally Advanced or Metastatic NSCLC --Metastatic Breast Cancer --NSCLC --Pancreatic --Unresectable Pancreatic OPDIVO ª --1L Metastatic Melanoma --1L Gastric --Esophageal Squamous Cell Carcinoma --1L Esophageal --Adjuvant Melanoma --Adjuvant Bladder --Adjuvant Esophageal/Gastroesophageal --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 (fixed dose nivolumab + relatlimab) --1L Melanoma YERVOY ª --Adjuvant Melanoma --Metastatic Melanoma 10 IMMUNOLOGY PHASE I PHASE II PHASE III APPROVED INDICATIONS Investigational Compounds afimetoran (TLR7/8 Inhibitor) --Cutaneous Lupus Erythematosus Anti-CD40 --Autoimmune Disease RIPK1 Inhibitor --Autoimmune Disease IL2-CD25 --Autoimmune Disease PKCθ Inhibitor --Autoimmune Disease TYK2 Inhibitor --Autoimmune Disease Additional Indications SOTYKTU (deucravacitinib) --Crohn's Disease --Alopecia Areata --Ulcerative Colitis --Discoid Lupus Erythematosus Investigational Compounds Afimetoran --Systemic Lupus Erythematosus Additional Indications SOTYKTU (deucravacitinib) --Psoriatic Arthritis --Systemic Lupus Erythematosus ZEPOSIA --Crohn’s Disease Investigational Compounds cendakimab --Eosinophilic Esophagitis 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 (deucravacitinib) --Moderate-to-Severe Psoriasis ZEPOSIA --Relapsing Multiple Sclerosis --Moderate-to-Severe Ulcerative Colitis CARDIOVASCULAR PHASE I PHASE II PHASE III APPROVED INDICATIONS Investigational Compounds Factor XIa Inhibitor ª --Thrombotic Disorders Additional Indications CAMZYOS (mavacamten) --Heart Failure with Preserved Ejection Fraction (HFpEF) Investigational Compounds Cardiac Myosin Inhibitor (MYK-224) --Obstructive Hypertrophic Cardiomyopathy danicamtiv --Genetic Dilated Cardiomyopathy Additional Indications CAMZYOS (mavacamten) --Non-obstructive Hypertrophic Cardiomyopathy milvexian ª --Secondary Stroke Prevention (SSP) # CAMZYOS (mavacamten) --Symptomatic Obstructive Hypertrophic Cardiomyopathy ELIQUIS ª --Stroke Prevention in Atrial Fibrillation --Venous Thromboembolism Prevention --Orthopedic Surgery --Venous Thromboembolism Treatment 11 FIBROTIC DISEASES PHASE II Investigational Compounds HSP47 ª --Non-Alcoholic Steatohepatitis LPA 1 Antagonist --Pulmonary Fibrosis NEUROSCIENCE PHASE I Investigational Compounds Anti-Tau ª --Neuroscience BTK Inhibitor --Neuroscience eIF2b Activator ª --Neuroscience FAAH/MGLL Dual Inhibitor --Neuroscience Note: Above pipeline excludes clinical collaborations ª Development Partnerships: ABECMA (ide-cel): 2seventy bio; AHR: Ikena Oncology; Anti-Tau: Prothena; CAMZYOS in China, Singapore, Thailand, Macau, HK, Taiwan: LianBio; Claudin 18.2 ADC: LaNova Medicines; CD3xPSCA: Avencell; eIF2b Activator: Evotec; ELIQUIS : Pfizer; EMPLICITI : AbbVie; farletuzumab ecteribulin: Eisai; HSP47: Nitto Denko Corporation; rHuPH20: Halozyme; IDHIFA : Servier; MAGEA4/8 TCER: Immatics; milvexian: Janssen Pharmaceuticals, Inc.; OPDIVO , YERVOY , OPDUALAG : Ono; REBLOZYL : Merck; SHP2 Inhibitor: BridgeBio Pharma; TIGIT Bispecific: Agenus; PKCθ Inhibitor: Exscientia ^ Trial(s) exploring various combinations # Partner-run study The following are our registrational study readouts anticipated through 2023/2025: Oncology Hematology Asset Tumor Trial Timing Asset Disease Trial Timing Opdivo + Yervoy 1L HCC CM-9DW 2024/25 Breyanzi 3L+ CLL TRANSCEND-CLL 2023 Opdivo + Yervoy 1L+ MSI High CRC CM-8HW 2024/25 3L+ Follicular Lymphoma TRANSCEND-FL 2023 Opdivo + Yervoy Adj.
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.
Zeposia ® Zeposia (ozanimod) is an oral immunomodulatory drug used to treat moderately to severely active UC and relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
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.
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/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” RDP regime.
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 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. 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.
Specific aspects of the law governing market exclusivity 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 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.
Also, the European patent system has an opposition procedure in which generic manufacturers may challenge the validity of patents covering innovator products within nine months of grant. In general, EU law treats chemically-synthesized drugs and biologically-derived drugs the same with respect to intellectual property and RDP.
Also, the European patent system has an opposition procedure in which generic manufacturers may challenge the validity of patents covering innovator products within nine months of grant. 5 In general, EU law treats chemically-synthesized drugs and biologically-derived drugs the same with respect to intellectual property and RDP.
For further discussion of the regulatory impact on our manufacturing, refer to “—Government Regulation” above. 18 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.
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.
Pollution controls and permits are required for many of our operations, and these permits are subject to modification, renewal or revocation by the issuing authorities. 19 Our environment, occupational health, safety and sustainability group monitors our operations around the world, providing us with an overview of regulatory requirements and overseeing the implementation of our standards for compliance.
Pollution controls and permits are required for many of our operations, and these permits are subject to modification, renewal or revocation by the issuing authorities. Our environment, occupational health, safety and sustainability group monitors our operations around the world, providing us with an overview of regulatory requirements and overseeing the implementation of our standards for compliance.
We have significant manufacturing operations in the U.S., Puerto Rico, Ireland and Switzerland. Most of our revenues come from products in the following therapeutic classes: hematology, oncology, cardiovascular and immunology.
We have significant manufacturing operations in the U.S., Puerto Rico, Switzerland, Ireland, and the Netherlands. Most of our revenues come from products in the following therapeutic classes: hematology, oncology, cardiovascular and immunology.
Breyanzi ® Breyanzi (lisocabtagene maraleucel) is a CD19-directed genetically modified autologous CAR-T cell therapy indicated for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after one or more lines of systemic therapy, including diffuse large B-cell lymphoma not otherwise specified, high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B.
Breyanzi ® Breyanzi (lisocabtagene maraleucel) is a CD19-directed genetically modified autologous CAR-T cell therapy indicated for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after one or more lines of systemic therapy, including diffuse large B-cell lymphoma not otherwise specified, high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and FL grade 3B.
Our operations include several marketing and sales organizations. Each product marketing organization is supported by a sales force, which may be responsible for selling one or more products. We also have marketing organizations that focus on certain classes of customers such as managed care entities or certain types of marketing tools, such as digital or consumer communications.
Our operations include several marketing and sales organizations. Each product marketing organization is supported by a sales force, which is responsible for selling one or more products. We also have marketing organizations that focus on certain classes of customers such as managed care entities or certain types of marketing tools, such as digital or consumer communications.
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 recently enacted 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 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.
The SEC allows us to disclose important information by referring to it in that manner. Please refer to such information. Our 2023 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 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
(m) For Sprycel, in the U.S., BMS entered into settlement agreements with Apotex Inc. and certain other generic companies regarding patents covering certain polymorphic forms of dasatinib whereby the generic companies can launch their generic dasatinib ANDA products in September 2024, or earlier in certain circumstances.
(n) For Sprycel, in the U.S., BMS entered into settlement agreements with Apotex Inc. and certain other companies regarding patents covering certain polymorphic forms of dasatinib whereby the generic companies can launch their generic dasatinib ANDA products in September 2024, or earlier in certain circumstances.
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. We have a broad early-to-mid stage pipeline with over 50 unique assets in clinical development.
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. We have a broad early-to-mid stage pipeline with over 40 unique assets in clinical development.
Survey results are reviewed by our executive officers and board of directors, who analyze areas of progress or opportunity both at a company level as well as at a function level. Individual managers use survey results to implement actions and activities intended to increase the well-being of our employees.
Survey results are reviewed by our executive officers and board of directors, who analyze areas of progress or opportunity both at a company level as well as at a function level. Individual managers use survey results to implement actions and activities intended to increase the wellbeing of our employees.
EU (o) Japan Abecma (idecabtagene vicleucel) 2036 2035 2035 Abraxane (paclitaxel) (a) ^^ ^^ ^^ Breyanzi (lisocabtagene maraleucel) (b) 2033 2033 2033 Camzyos (mavacamten) (c) 2034 ++ ++ Eliquis (apixaban) (d) 2026 ^^ 2026 Empliciti (elotuzumab) 2029 2029 2029 Inrebic (fedratinib) (e) 2026 2031 ++ Onureg (azacitidine) (f) 2027 ^^ ++ Opdivo (nivolumab) 2028 2030 2031 Opdualag (nivolumab and relatlimab-rmbw) (g) 2034 2033 ++ Orencia (abatacept) (h) ^^ ^^ ^^ Pomalyst/Imnovid (pomalidomide) (i) ^^ 2024 ^^ Reblozyl (luspatercept-aamt) (j) 2031 2030 ++ Revlimid (lenalidomide) (k) ^^ ^^ ^^ Sotyktu (deucravacitinib) (l) 2033 ++ 2033 Sprycel (dasatinib) (m) ^^ ^^ ^^ Yervoy (ipilimumab) 2025 2026 2025 Zeposia (ozanimod) (n) 2029 2030 ++ 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 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.
We have been generally, although not universally, successful in having our major products included on MCO or 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. 15 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 data 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 RDP exclusivity) is currently estimated to occur in the U.S., the EU and Japan (the “estimated minimum market exclusivity date”).
From on-demand, open-enrollment learning journeys to customized, nomination-based experiences, we aim to unlock personal potential through exceptional learning experiences. Our extensive library of resources, available in multiple languages to our 30,000+ employees, covers a wide range of specialized subjects. In 2022, over 6,800 employees enrolled into our professional, manager, and leadership development programs.
From on-demand, open-enrollment learning journeys to customized, nomination-based experiences, we aim to unlock personal potential through exceptional learning experiences. Our extensive library of resources, available in multiple languages to our 30,000+ employees, covers a wide range of specialized subjects. In 2023, over 6,800 employees were enrolled into our professional, manager, and leadership development programs.
(d) For Eliquis , in the U.S., two patents listed in the FDA Orange Book, the composition of matter patent claiming apixaban specifically (expiring 2026) and a formulation patent (expiring 2031), were challenged by numerous generic companies.
(e) For Eliquis , in the U.S., two patents listed in the FDA Orange Book, the composition of matter patent claiming apixaban specifically (expiring 2026) and a formulation patent (expiring 2031), were challenged by numerous generic companies.
We also incur operating and capital costs for such matters on an ongoing basis, which were not material for 2022, 2021 and 2020. 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 2023, 2022 and 2021. In addition, we invested in projects that reduce resource use of energy and water.
For additional information relating to our acquisitions, divestitures, licensing and other arrangements refer to “Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations—Acquisitions, Divestitures, Licensing and Other Arrangements” and “Item 8. Financial Statements and Supplementary Data—Note 4.
For additional information relating to our acquisitions, divestitures, licensing and other arrangements refer to “Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations—Acquisitions, Divestitures, Licensing and Other Arrangements”, “Item 8. Financial Statements and Supplementary Data—Note 3. Alliances”, and “Item 8. Financial Statements and Supplementary Data—Note 4. Acquisitions, Divestitures, Licensing and Other Arrangements”.
(f) For Onureg in the U.S., the estimated minimum market exclusivity date of 2027 is based on seven years of orphan drug exclusivity. Formulation patents covering Onureg expire in 2030 in the U.S., and in 2029 in the EU and Japan.
(f) In the EU, the estimated minimum market exclusivity date is based on RDP exclusivity. (g) For Onureg in the U.S., the estimated minimum market exclusivity date of 2027 is based on seven years of orphan drug exclusivity. Formulation patents covering Onureg expire in 2029 and 2030 in the U.S., and in 2029 in the EU and Japan.
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 Opdivo , Eliquis, Sprycel , Yervoy, Reblozyl, Inrebic, Abraxane, and Pomalyst/Imnovid.
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.
A significant portion of a product’s patent life, however, is lost during the time it takes an innovative company to develop and obtain regulatory approval of a new drug.
A significant portion of a product’s patent life, however, is lost during the time it takes an innovator company to develop and obtain regulatory approval of a new drug.
(“Natco”) and its partners and affiliates, Natco was granted a volume-limited license to sell generic lenalidomide in the U.S. commencing in March 2022. Certain other generic companies have been granted volume-limited licenses to sell generic lenalidomide in the U.S. beginning on confidential dates that are sometime after the March 2022 volume-limited license date provided to Natco.
(“Natco”) and its partners and affiliates, Natco was granted a volume-limited license to sell generic lenalidomide in the U.S. commencing in March 2022. Certain other generic companies were granted volume-limited licenses to sell generic lenalidomide in the U.S. beginning on confidential dates that are sometime after the March 2022 volume-limited license date provided to Natco.
The EPO Opposition Division found two of these formulation patents invalid, and the decisions are being or will be appealed. Refer to “Item 8. Financial Statements and Supplementary Data—Note 20. Legal Proceedings and Contingencies” for more information. (g) For Opdualag in the U.S., a PTR application is pending and, if granted, the estimated patent expiry will be 2036.
The EPO Opposition Division found three of these formulation patents invalid, and the decisions are being or will be appealed. Refer to “Item 8. Financial Statements and Supplementary Data—Note 20. Legal Proceedings and Contingencies” for more information. (h) For Opdualag in the U.S., a PTR application is pending and, if granted, the estimated patent expiry will be 2036.
Orencia ® Orencia (abatacept), a biological product, is a fusion protein indicated for adult patients with moderately to severely active RA and PsA, 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, 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.
We continue to 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.
In these markets, a significant portion of funding for healthcare services and the determination of pricing and reimbursement for pharmaceutical products are subject to either direct government control at the point of care or governments having significant power as the primary payer.
In these markets, a significant portion of funding for healthcare services and the determination of pricing and reimbursement for pharmaceutical products are subject to either direct government control at the point of care or governments serving as the primary payer.
Listed below are our clinical studies and approved indications for our marketed products in the related therapeutic area as of February 2, 2023.
Listed below are our clinical studies and approved indications for our marketed products in the related therapeutic area as of February 2, 2024.
Refer to the Summary of Abbreviated Terms at the end of this 2022 Form 10-K for definitions of capitalized terms used throughout the document. 1 Acquisitions, Divestitures, Licensing and Other Arrangements Acquisitions, divestitures and other licensing arrangements allow us to focus our resources behind growth opportunities that drive the greatest long-term value.
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.
The information contained in or connected to our website is not deemed to be incorporated by reference in this 2022 Form 10-K or filed with the SEC. We incorporate by reference certain information from parts of our definitive proxy statement for our 2023 Annual Meeting of Shareholders (“2023 Proxy Statement”).
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”).
Acquisitions, Divestitures, Licensing and Other Arrangements.” 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.
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.
Currently, we are involved in investigation and remediation at 16 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.
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.
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. R&D expenses were $9.5 billion in 2022, $10.2 billion in 2021 and $10.0 billion in 2020.
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.
Revlimid and Pomalyst are distributed in the United States 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 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 .
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.
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.
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, 2022, we had approximately 34,300 employees in 44 countries.
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.
In the EU, the apixaban composition of matter patents and related Supplementary Protection Certificates (“SPCs”) expire in 2026. Generics have challenged the composition of matter patents and related SPCs in various jurisdictions and trials have taken place, or are scheduled to take place, in certain European countries.
In the EU, the apixaban composition of matter patents and related SPCs expire in 2026. Generics have challenged the composition of matter patents and related SPCs in various jurisdictions and trials have taken place, or are scheduled to take place, in certain European countries.
Several governments have placed restrictions on physician prescription levels and patient reimbursements, emphasized greater use of generic drugs and/or enacted across-the-board price cuts or rebate schemes as methods of cost control.
Several governments have placed restrictions on physician prescription levels and patient reimbursements, emphasized greater use of generic drugs and/or enacted mandated price cuts or rebate schemes as methods of cost control.
We concentrate our R&D efforts in the following disease areas with significant unmet medical needs: oncology, including lung, bladder, renal, gastric and esophageal, head and neck, colorectal, melanoma tumor types; hematology and cell therapy, including multiple myeloma, lymphoma, and chronic lymphocytic leukemia; immunology including relapsing multiple sclerosis, psoriasis, lupus, rheumatoid arthritis and inflammatory bowel disease; cardiovascular, including cardiomyopathy, heart failure and thrombotic disorders; and fibrotic disease, specifically lung and liver.
We concentrate our R&D efforts in the following disease areas with significant unmet medical needs: oncology, including lung, bladder, renal, gastric and esophageal, head and neck, colorectal, melanoma tumor types; hematology and cell therapy, including multiple myeloma, lymphoma, and chronic lymphocytic leukemia; immunology including relapsing multiple sclerosis, psoriasis, lupus, RA and inflammatory bowel disease; cardiovascular, including cardiomyopathy, heart failure and thrombotic disorders; fibrotic disease, specifically lung and liver; and neuroscience conditions, including neuroinflammation, neurodegeneration and neuropsychiatry.
In the EU, an SPC application is pending and, if granted, the estimated patent expiry will be 2037. (h) 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 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.
Our PBRGs include the Black Organization for Leadership and Development, the BMS Network of Women, the Cultivating Leadership and Innovation for Millennials and Beyond, the Disability Advancement Workplace Network, the PRIDE Alliance, the Organization for Latino Achievement, the Pan Asian Network and the Veterans Community Network.
Our PBRGs include the Black Organization for Leadership and Development, the BMS Network of Women, the Cultivating Leadership and Innovation for Multigenerational and Belonging, the Disability Advancement Workplace Network, the PRIDE Alliance, the Organization for Latino Achievement, the Pan Asian Network and the Veterans Community Network.
For biologics, the failure rate is approximately 87% from Phase I development, approximately 71% from Phase II development and approximately 29% from Phase III. R&D expenses include the costs of discovery research, preclinical development, early-stage and late-stage clinical development, drug formulation, post-commercialization and medical support of marketed products, and proportionate allocations of enterprise-wide costs.
For biologics, the failure rate is approximately 89% from Phase I development, approximately 73% from Phase II development and approximately 26% from Phase III. R&D expenses include the costs of discovery research, preclinical development, early-stage and late-stage clinical development, drug formulation, post-commercialization and medical support of marketed products, and proportionate allocations of enterprise-wide costs.
For Japan, the estimated minimum market exclusivity date is 2026 based on a method of use patent. (j) 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 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.
On August 16, 2022, President Biden signed the IRA 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 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 coverage gap provisions 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 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.
In most EU countries, for example, the government regulates pricing of a new product at launch often through direct price controls, international price comparisons, controlling profits and/or reference pricing and prices are often reevaluated and further restricted throughout the life of the medicine.
In most EU countries, for example, the government regulates pricing of a new product at launch often through direct price controls, international price comparisons, and/or reference pricing to the current standard of care. Prices are often reevaluated and further restricted throughout the life of the medicine.
(b) For Breyanzi in the U.S., a PTR application is pending and, if granted, the estimated patent expiry will be 2034. (c) For Camzyos in the U.S., a PTR application is pending and, if granted, the estimated patent expiry will be 2036.
(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.
These trends have been accelerating in recent years. For example, in 2022, Germany reformed its pricing and reimbursement system to further restrain pharmaceutical spending by reducing its “free pricing” period and introducing new cost-containment measures on medicines based on their value assessment results, and use in combination with other medicines, and more.
For example, in 2022, Germany reformed its pricing and reimbursement system to further restrain pharmaceutical spending by reducing its “free pricing” period and introducing new cost-containment measures on medicines based on their value assessment results, and use in combination with other medicines, and more.
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.
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.
The percentage of revenues by significant region/country were as follows: Year Ended December 31, Dollars in Millions 2022 2021 2020 United States 69 % 63 % 63 % International 29 % 35 % 36 % Other (a) 2 % 2 % 1 % Total Revenues $ 46,159 $ 46,385 $ 42,518 (a) Other revenues include royalties and alliance-related revenues for products not sold by BMS ’ s regional commercial organizations.
The percentage of revenues by significant region/country were as follows: Year Ended December 31, Dollars in millions 2023 2022 2021 United States 70 % 69 % 63 % International 28 % 29 % 35 % Other (a) 2 % 2 % 2 % Total Revenues $ 45,006 $ 46,159 $ 46,385 (a) Other revenues include royalties and alliance-related revenues for products not sold by BMS ’ s regional commercial organizations.
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.
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.
Our priorities are to continue to renew and diversify our portfolio through launching our new product portfolio, advancing our early, mid and late-stage pipeline, and executing disciplined business development. We remain committed to strengthening our balance sheet and returning capital to shareholders. For a further discussion of our strategy initiatives, refer to “Item 7.
Our priorities are to continue renewing and diversifying our portfolio, advancing our early, mid and late-stage pipeline, and executing disciplined business development. We remain committed to strengthening our balance sheet and returning capital to shareholders. For a further discussion of our strategy initiatives, refer to “Item 7.
While these legal proceedings are pending, generic manufacturers have begun marketing generic versions of Eliquis in the UK and the Netherlands and may seek to market generic versions of Eliquis in other European countries prior to the expiration date of apixaban patents and related SPCs. Refer to “Item 8. Financial Statements and Supplementary Data—Note 20.
While these legal proceedings are pending, generic manufacturers have begun marketing generic versions of Eliquis in certain EU countries and may seek to market generic versions of Eliquis in other EU countries prior to the expiration date of apixaban patents and related SPCs. Refer to “Item 8. Financial Statements and Supplementary Data—Note 20. Legal Proceedings and Contingencies” for more information.
In the EU, an SPC application on a method of treatment patent is pending and if granted, the estimated patent expiry will be 2034. (k) For Revlimid, in the U.S., as part of the settlement with Natco Pharma Ltd.
In the EU, SPC applications on a method of treatment patent are pending and if granted, the estimated patent expiry will be 2034. (l) For Revlimid, in the U.S., as part of the settlement with Natco Pharma Ltd.
To successfully compete for formulary position with MCOs and PBMs, we must often demonstrate that our products offer not only medical benefits but also cost advantages as compared with other forms of care. Exclusion of a product from a formulary can lead to its sharply reduced usage in patient populations. Consequently, pharmaceutical companies compete aggressively to have their products included.
To successfully compete for formulary position with MCOs and PBMs, we must often demonstrate that our products offer not only medical benefits but also cost advantages as compared with other forms of care. Exclusion of a product from a formulary can lead to its sharply reduced usage in patient populations due to higher out-of-pocket costs to patients.
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.
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.
Additionally, countries outside of the U.S. have regularly imposed new or additional cost containment measures for pharmaceuticals such as volume discounts, cost caps, cost sharing for increases in excess of prior year costs for individual products or aggregated market level spending, clawbacks and free products for a portion of the expected therapy period.
Additionally, countries outside of the U.S. have regularly imposed new or additional cost containment measures for pharmaceuticals such as volume discounts, cost caps, cost sharing for increases in excess of prior year costs for individual products or aggregated market level spending and clawbacks. These trends have been accelerating in recent years.
Lawsuits filed by BMS are pending against other companies that filed 505(b)(2) NDA applications containing paragraph IV certifications seeking approval of dasatinib products in the U.S.
Lawsuits filed by BMS are pending against other generic companies containing paragraph IV certifications seeking approval of dasatinib products in the U.S.
According to the KMR Group, based on industry success rates from 2017-2021, approximately 89% of small molecules that enter Phase I development fail to achieve regulatory approval. Small molecules that enter Phase II development have a failure rate of approximately 75% while approximately 24% of Phase III small molecules fail to achieve approval.
According to the KMR Group, based on industry success rates from 2018-2022, approximately 92% of small molecules that enter Phase I development fail to achieve regulatory approval. Small molecules that enter Phase II development have a failure rate of approximately 80% while approximately 31% of Phase III small molecules fail to achieve approval.
In Japan, the composition of matter patent has been extended to 2024 for the treatment of non-imatinib-resistant CML, but generics have been approved for other indications. Refer to “Item 8. Financial Statements and Supplementary Data—Note 20. Legal Proceedings and Contingencies” for more information.
In Japan, the composition of matter patent has been extended to 2024 for the treatment of non-imatinib-resistant CML, however, a generic dasatinib product has already launched for all approved indications. Refer to “Item 8. Financial Statements and Supplementary Data—Note 20. Legal Proceedings and Contingencies” for more information.
Among developing countries, some have adopted patent laws and/or regulatory exclusivity laws, while others have not. Some developing countries have formally adopted laws in order to comply with WTO commitments, but have not taken steps to implement these laws in a meaningful way.
Most other developed countries utilize systems similar to either the U.S. or the EU. Among developing countries, some have adopted patent laws and/or regulatory exclusivity laws, while others have not. Some developing countries have formally adopted laws in order to comply with WTO commitments, but have not taken steps to implement these laws in a meaningful way.
Under Project Orbis, earlier approvals from the Australian, Therapeutic Goods Administration (“TGA”), Health Canada and Singapore Health Sciences Authority were received on the combination of Opdivo + Yervoy given with two cycles of platinum-doublet chemotherapy in 2020. 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. 16 The FDA mandates that drugs be manufactured, packaged and labeled in conformity with cGMP established by the FDA.
Management’s Discussion and Analysis of Financial Condition and Results of Operations—Executive Summary.” Our activities outside the U.S. are also subject to regulatory requirements governing the testing, approval, safety, effectiveness, manufacturing, labeling and marketing of our products. These regulatory requirements vary from country to country.
Our activities outside the U.S. are also subject to regulatory requirements governing the testing, approval, safety, effectiveness, manufacturing, labeling and marketing of our products. These regulatory requirements vary from country to country.
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.
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.
We also participate in the Public Health Service’s 340B program, under which we must charge statutorily defined covered entities no more than the 340B program “ceiling price” for our covered outpatient drugs, with that price calculated based on MDRP-reported data.
We also participate in the Health Resources and Services Administration's 340B program, under which we must offer covered outpatient drugs to statutorily defined covered entities at no more than the 340B program “ceiling price”, with that price calculated based on MDRP-reported data.
We are also now required to comply with recently enacted 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 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.
Our Global Inclusion & Diversity strategy leads with our Value of Inclusion, one of our six core values, is regionally and locally relevant, and strengthens the human connection we bring to work every day to discover, develop and deliver medicines that help patients prevail over serious diseases.
Our Global I&D strategy leads with our Value of Inclusion, one of our six core values, is regionally and locally relevant, and strengthens the human connection we bring to work every day to discover, develop and deliver medicines that help patients prevail over serious diseases. 20 We thrive on a culture of belonging which cultivates and encourages inclusive engagement and innovation.
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.
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.
In the U.S., Accord Healthcare Inc. has challenged the formulation patent, which is listed in the FDA Orange Book, and litigation is ongoing. In the EU, three formulation patents (EP 2,299,984; EP 2,695,609; and EP 3,692,983) cover Onureg and they are in pending opposition proceedings.
In the U.S., generic companies have challenged the formulation patents, which are listed in the FDA Orange Book, and litigation is ongoing. In the EU, we have four formulation patents (EP 2,299,984; EP 2,695,609; EP 3,692,983; and EP 3,782,611) that cover Onureg and they are in pending opposition proceedings.
Acquired IPRD expenses were $815 million, $1.2 billion and $12.5 billion in 2022, 2021 and 2020, respectively. In 2020, Acquired IPRD included an $11.4 billion charge resulting from the MyoKardia acquisition. We manage our R&D programs on a product portfolio basis, investing resources in each stage of R&D from early discovery through late-stage development.
Acquired IPRD expenses were $913 million in 2023, $815 million in 2022 and $1.2 billion in 2021. We manage our R&D programs on a product portfolio basis, investing resources in each stage of R&D from early discovery through late-stage development.
Internationally, Revlimid and Imnovid are distributed under mandatory risk-management distribution programs tailored to meet local authorities’ specifications to provide for the product’s safe and appropriate distribution and use. Camzyos is only available through a restricted program called the Camzyos REMS Program.
Internationally, Revlimid and Imnovid are distributed under mandatory risk-management distribution programs tailored to meet local authorities’ specifications to provide for the product’s safe and appropriate distribution and use. Camzyos is only available through the Camzyos REMS Program. Product distribution is limited to REMS certified pharmacies, and enrolled pharmacies must only dispense to patients who are authorized to receive Camzyos .
As a result of all of these developments, among others, it is not possible to predict the length of market exclusivity for a particular product with certainty based solely on the expiration of the relevant patent(s) or the current forms of regulatory exclusivity. Our marketed biologic products include Opdivo , Orencia, Yervoy , Empliciti, Reblozyl, Abecma, Opdualag and Breyanzi.
As a result of these developments, among others, it is not possible to predict the length of market exclusivity for a particular product with certainty based solely on the expiration of the relevant patent(s) or the current forms of regulatory exclusivity.
In addition, in support of our continued investment in our cell therapy portfolio, we are expanding our manufacturing capabilities through the construction of new state-of-the-art cell therapy manufacturing facilities in Devens, Massachusetts and Leiden, Netherlands.
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 to the relevant legislation and annexes related to biologic medicinal products, the EMA has issued guidelines that outline the additional information to be provided for biosimilar products, also known as generic biologics, in order to review an application for marketing approval. 5 Japan In Japan, medicines of new chemical entities are generally afforded eight years of RDP for approved indications and dosage.
In addition to the relevant legislation and annexes related to biologic medicinal products, the EMA has issued guidelines that outline the additional information to be provided for biosimilar products, also known as generic biologics, in order to review an application for marketing approval.
We continually evaluate our portfolio of R&D assets to ensure that there is an appropriate balance of early-stage and late-stage programs to support the future growth of the Company. Spending on our late-stage development programs represented approximately 45% of our annual R&D expenses in 2022.
We continually evaluate our portfolio of R&D assets to ensure that there is an appropriate balance of early-stage and late-stage programs to support the future growth of the Company. Spending on our late-stage development programs represented approximately 42% of our annual R&D expenses in 2023. Our drug discovery and development work takes place across a network of state-of-the-art facilities worldwide.
We thrive on a culture of belonging which cultivates and encourages inclusive engagement and innovation. 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.
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.
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, Netherlands, as well as third-party manufacturers. Beyond regulatory requirements, many of our products involve technically sophisticated manufacturing processes or require specialized raw materials.
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.

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

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Biggest changeIn addition, the patent environment can be unpredictable and the validity and enforceability of patents cannot be predicted with certainty. In addition, manufacturers of innovative drugs as well as generic drug manufacturers may be able to design their products around our owned or licensed patents and compete with us using the resulting alternative technology.
Biggest changeFurthermore, manufacturers of innovative drugs as well as generic drug manufacturers may be able to design their products around our owned or licensed patents and compete with us using the resulting alternative technology. Absent relevant patent protection for a product, once the data exclusivity period expires, generic or alternative versions can be approved and marketed.
Risk Factors—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.
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.
Global economic conditions or events such as wars or pandemics also create additional risks from their impact on our suppliers, vendors, outsourcing partners, alliance partners and other third parties that we rely on to research, develop, manufacture, commercialize, co-promote and sell our products, manage certain marketing, selling, human resource, finance, IT and other business 30 unit and functional services.
Global economic conditions or events such as wars or pandemics also create additional risks from their impact on our suppliers, vendors, outsourcing partners, alliance partners and other third parties that we rely on to research, develop, manufacture, commercialize, co-promote and sell our products, manage certain marketing, selling, human resource, finance, IT and other business unit and functional services.
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 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 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.
Some 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 25 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 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.
Some 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.
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 approval and related launch date of a new product could negatively impact our revenues and earnings.
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.
We rely extensively on information technology systems, networks and services, including internet sites, data hosting and processing facilities and tools, physical security systems and other hardware, software and technical applications and platforms, some of which are managed, hosted, provided and/or used for third-parties or their vendors, to assist in conducting our business.
We rely extensively on information technology systems, networks and services, including internet sites, data hosting and processing facilities and tools, physical security systems and other hardware, software and technical applications and platforms, some of which are managed, hosted, provided by and/or used for third parties or their vendors, to assist in conducting our business.
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.
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.
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, government negotiations/price controls that may 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 eliminates 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, 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.
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 23 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 funds we invest in research programs will not generate financial returns.
It is also 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 and/or increased governmental regulation.
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.
Additionally, certain study results, especially from head-to-head studies, could affect a product’s formulary listing, which could also adversely affect revenues. 27 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.
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.
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. 31 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. 32 Item 1B.
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 2022 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 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.
It is possible that global economic and political events, including any future pandemic, could exacerbate any of the other risks described in this 2022 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 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.
Notably, in July and October 2021 OECD/G20 Inclusive Framework agreed on the general rules for redefined jurisdictional taxation rights and a global minimum tax. In December 2022, the EU member states voted unanimously to adopt a Directive implementing the Pillar 2 (global minimum tax) rules giving member states until December 31, 2023 to implement the Directive into national legislation.
Notably, in July and October 2021 OECD/G20 Inclusive Framework agreed on the general rules for redefined jurisdictional taxation rights and a global minimum tax. 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.
Resolving an intellectual property infringement claim can be costly and time consuming and may require us to enter into license agreements, which may not be available on commercially reasonable terms.
Resolving an intellectual property infringement or other claim can be costly and time consuming and may require us to enter into license agreements, which may not be available on commercially reasonable terms.
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 $2.5 billion in 2022.
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.
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 Risk Evaluation and Mitigation Strategy ("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. Regulatory approval delays are especially common when a product is expected to have a REMS program, as required by the U.S.
In some countries, patent protection is significantly weaker than in the United States 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. For additional information, see “Item 1A.
Any such delays or difficulties in clinical development could also potentially lead to a material impairment of our intangible assets, including the $35.9 billion of intangible assets as of December 31, 2022. 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 $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.
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 phishing, social engineering and malware attacks.
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.
Moreover, due to the substantial amount of debt that we incurred to finance the cash portion of the Celgene and MyoKardia acquisitions, there can be no assurance of when we will be 29 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 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.
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.
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 such, a global economic downturn could create or amplify a variety of risks to our business and could negatively affect our growth. 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 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.
A reduction in revenue from any 28 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 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.
Adverse changes in U.S. and global economic and political conditions could adversely affect our operations and profitability. 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 2022.
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.
Absent relevant patent protection for a product, once the data exclusivity period expires, generic or alternative versions can be approved and marketed. 24 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 could face earlier-than-expected competition for any products at any time.
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.
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.
Market, Liquidity and Credit Risks We have significant indebtedness that could have negative consequences . Our acquisitions of Celgene and MyoKardia increased the amount of our debt resulting in additional interest expense. This could reduce our financial flexibility to continue capital investments, develop new products and declare future dividends.
Market, Liquidity and Credit Risks We have significant indebtedness that could have negative consequences . Our acquisitions of Celgene, MyoKardia and Mirati increased the amount of our debt resulting in additional interest expense, and we intend to incur more debt to finance future acquisitions, including the Karuna and RayzeBio acquisitions.
Business—Pricing, Price Constraints and Market Access.” Changes to tax regulations could negatively impact our earnings. We are subject to income taxes in the U.S. and various other countries globally. Changes in tax laws and regulations can and do occur.
Changes to tax regulations could negatively impact our earnings. We are subject to income taxes in the U.S. and various other countries globally. Changes in tax laws and regulations can and do occur. Significant judgment is required for determining the Company’s tax liabilities, and the Company’s tax returns are periodically examined by various tax authorities.
Our pretax income could be adversely affected if the royalty streams decline in future periods. Failure to execute our business strategy or to identify and effectively manage acquisitions, divestitures, alliances, joint ventures and other portfolio actions could adversely impact our growth and profitability and our future results.
In addition, our royalties from our divested diabetes business, specifically Amylin, Farxiga and Onglyza, terminate on December 31, 2025. Failure to execute our business strategy or to identify and effectively manage acquisitions, divestitures, alliances, joint ventures and other portfolio actions could adversely impact our growth and profitability and our future results.
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, the U.S. FDA has indicated it is undertaking an industry-wide review of indications that received accelerated approval and for which the confirmatory studies did not meet their primary endpoints.
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.
The value allocated to certain of our assets could be substantially impaired due to a number of factors beyond our control. 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.
The value allocated to certain of our assets could be substantially impaired due to a number of factors beyond our control.
There can be no assurance that our continuing efforts will prevent breakdowns or breaches to our or our third-party providers’ databases or systems that could adversely affect our business. Strategic, Business Development and Employee Attraction and Retention Risks We depend on several key products for most of our revenues, cash flows and earnings.
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.
Any future replacement, modification or repeal of the ACA may adversely affect our business and financial results, particularly if the legislation reduces incentives for employer-sponsored insurance coverage. We cannot predict how other future federal or state legislative or administrative changes relating to healthcare reform will affect our business. For additional information, refer to “Item 1. Business—Government Regulation” and “Item 1.
FDA additional authority to require confirmatory trials to be underway at the time of approval and offered an additional enforcement mechanism if sponsors do not complete such studies with due diligence. We cannot predict how other future federal or state legislative or administrative changes relating to healthcare reform will affect our business. For additional information, refer to “Item 1.
Further details regarding implementation of these rules are expected and if implemented could have a material impact on our tax provision and results of operations. The failure of third parties to meet their contractual, regulatory and other obligations could adversely affect our business.
The implementation of Pillar Two is currently expected to increase our effective tax rate excluding specified items by approximately 1% in 2024. The failure of third parties to meet their contractual, regulatory and other obligations could adversely affect our business.
Information Technology and Cybersecurity Risks We are dependent on information technology and our systems and infrastructure face certain risks, including from cybersecurity breaches and data leakage.
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.
A significant breakdown, invasion, corruption, destruction or interruption of critical information technology systems or infrastructure, by our workforce, others with authorized access to our systems or unauthorized persons could negatively impact operations.
A significant breakdown, invasion, corruption, destruction or interruption of critical information technology systems or leak or theft of proprietary, confidential or personal information could negatively impact operations. There can be no assurance that our continuing efforts will prevent breakdowns or incidents to our or our third-party providers’ systems or databases that could adversely affect our business.
Removed
Regulatory, Intellectual Property, Litigation, Tax and Legal Compliance Risks Litigation claiming infringement of intellectual property may adversely affect our future revenues and operating earnings.
Added
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.
Removed
Also, we anticipate continued U.S. congressional interest in modifying provisions of the Patient Protection and Affordable Care Act (the “ACA”), particularly given its numerous legal challenges (such as the California v. Texas case) and polarized public support.
Added
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.
Removed
The 26 revenues that we generate by the health insurance exchanges and Medicaid expansion under the ACA are not material, so the impact of the change in law and similar recent administration actions is expected to be limited.
Added
Department of Health and Human Services selected Eliquis as one of the first 10 medicines subject to government-set prices beginning in 2026. The Medicare price setting process began in February 2024 and will conclude by August 1, 2024.
Removed
For example, the Tax Cuts and Jobs Act of 2017 (the "TCJA") reduced the U.S. tax rate to 21% and introduced broad and complex changes resulting in numerous new regulations and interpretations. Significant judgment is required for determining the Company’s tax liabilities, and the Company’s tax returns are periodically examined by various tax authorities.
Added
On September 1, 2024, CMS will publish prices that will be applicable to the ten drugs in the Medicare program beginning January 1, 2026. It is possible that more of our products will be selected in future years, which could, among other things, accelerate revenue erosion prior to expiry of intellectual property protections.
Removed
The ever-increasing use and evolution of technology, including cloud-based computing, creates opportunities for the unintentional dissemination or intentional destruction or modification of confidential information stored in our, or our third-party providers’ systems, portable media or storage devices.
Added
The IRA also requires drug manufacturers to provide rebates for Medicare Part B and Part D medicines under certain circumstances. The Part D benefit redesign will replace the Part D CGDP with a new manufacturer discount program.
Removed
We could also experience a business interruption, theft of confidential information or reputational damage from industrial espionage attacks, malware or other cyber-attacks, which may compromise our system infrastructure or lead to data leakage, either internally or at our third-party providers.
Added
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.
Removed
As the COVID-19 pandemic progressed, we observed an increase in cybersecurity incidents across the industry, predominantly ransomware and social engineering attacks. Further, government entities have also been the subject of cyberattacks.
Added
Manufacturers that fail to comply with the IRA may be subject to various penalties, including civil monetary penalties, which could be significant. The IRA has and will continue to meaningfully impact our business strategies and those of others in the pharmaceutical industry.
Removed
Although the aggregate impact of cybersecurity breaches and data leakage on our operations and financial condition have not been material to date, we have been the target of cyber-attacks and expect them to continue as cybersecurity threats have been rapidly evolving in sophistication and becoming more prevalent in the industry.
Added
The full impact of the IRA on our business and the pharmaceutical industry, including the implications to us of our or a competitor's product being selected for price setting, remains uncertain. 23 At the state level, multiple states are pursuing government actions and ballot initiatives to address or limit drug pricing and reimbursement for their Medicaid programs.
Removed
We have invested in industry-appropriate protections and monitoring practices of our data and IT to reduce these risks and continue to monitor our systems on an ongoing basis for any current or potential threats.
Added
These initiatives include attempts to use the IRA's referenced drug price at the state level. Some of these state-level proposals may also influence federal policy and legislation. Given the uncertainty surrounding the adoption and timing of these potential legislative, policy, or administrative changes, we are unable to predict their impact on our business.
Removed
While we maintain cyber insurance, this insurance may not, however, be sufficient to cover the financial, legal, business or reputational losses that may result from an interruption or breach of our systems.
Added
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.
Removed
We derive a majority of our revenue and earnings from several key products. We expect that Revlimid, Eliquis, and Opdivo will represent a significant percentage of our revenue, earnings and cash flows during the next few years.
Added
In addition, the patent environment can be unpredictable and the validity and enforceability of patents cannot be predicted with certainty. For example, for Eliquis, generics have challenged the composition of matter patents and related SPCs in various jurisdictions and trials have taken place, or are scheduled to take place, in certain European countries.
Added
While these legal proceedings are pending, generic manufacturers have begun marketing generic versions of Eliquis in certain EU countries and may seek to market generic versions of Eliquis in other EU countries prior to the expiration date of applicable patents and related SPCs.
Added
In addition, in December 2023, the Biden Administration released a proposed framework that for the first time proposed that a drug’s price can be a factor in determining that the drug is not accessible to the public and therefore that the government could exercise “march-in rights” and license it to a third party to manufacture.
Added
A comment period on the proposal ran through February 6, 2024, 25 and we are not able to predict whether a final rule will be adopted along the lines proposed and, if adopted, whether the government would seek to exercise march-in rights for any of our products.
Added
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.
Added
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.
Added
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.
Added
Expectations relating to environmental, social and governance considerations and related reporting obligations expose the Company to potential liabilities, increased costs, reputational harm, and other adverse effects on the Company’s business.
Added
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.
Added
We expect to experience increased restrictions and compliance costs, legal costs, and expenses related to such new or changing legal or regulatory requirements. Moreover, compliance with any such legal or regulatory requirements would require us to devote substantial time and attention to these matters.
Added
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.
Added
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.
Added
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.
Added
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.
Added
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.
Added
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.
Added
Cybersecurity risks continue to develop, including as a result of threat actors increasingly targeting employees and supply chains and geopolitical tensions leading to an increase in sabotage, espionage and cyber attacks .
Added
Under certain circumstances, such incidents when detected could require disclosure to government authorities and/or regulators and could require notification to impacted individuals and any such incident could result in material financial, legal, business and reputational harm to us.
Added
In addition, in the U.S., most of our products are distributed through wholesalers, and if one of these wholesalers should encounter financial or other difficulties, we might be unable to timely collect the amounts that the wholesaler owes us, which could negatively impact our results of operations.
Added
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.

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Item 2. Properties

Properties — owned and leased real estate

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Biggest changeItem 2. PROPERTIES. Our principal executive offices are located at 430 East 29th Street, 14 th Floor, New York, NY. We own or lease manufacturing, R&D, administration, storage and distribution facilities at approximately 190 sites worldwide.
Biggest changeItem 2. PROPERTIES. Our principal executive offices are located at Route 206 & Province Line Road, Princeton, NJ. We own or lease manufacturing, R&D, administration, storage and distribution facilities at approximately 130 sites worldwide.
Business—Manufacturing and Quality Assurance.” Our significant manufacturing and R&D locations by geographic area were as follows at December 31, 2022: Manufacturing R&D United States 7 9 Europe 1 1 Total 8 10
Business—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

Item 4. Mine Safety Disclosures

Mine Safety Disclosures — required of mining issuers

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Biggest changePowell Executive Vice President, Chief Human Resources Officer Member of the Leadership Team 57 2016 to 2019 – Senior Vice President, Chief Human Resources Officer 2019 to present – Executive Vice President, Chief Human Resources Officer Karin Shanahan Executive Vice President, Global Product Development & Supply Member of the Leadership Team 58 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 Rupert Vessey, M.A., B.M., B.Ch., F.R.C.P., D.Phil.
Biggest changeExecutive 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
Item 4. MINE SAFETY DISCLOSURES. Not applicable. 32 PART IA Information about our Executive Officers Listed below is information on our executive officers as of February 14, 2023.
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.
Elkins Executive Vice President and Chief Financial Officer Member of the Leadership Team 54 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 Sharon Greenlees Senior Vice President, Corporate Controller 51 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 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.
Name and Current Position Age Employment History for the Past 5 Years Giovanni Caforio, M.D. Chairman of the Board and Chief Executive Officer Member of the Leadership Team 58 2015 to 2017 – Chief Executive Officer and Director of the Company 2017 to present – Chairman of the Board and Chief Executive Officer Christopher Boerner, Ph.D.
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.
Executive Vice President, Chief Medical Officer, Global Drug Development Member of the Leadership Team 54 2017 to 2019 – Executive Vice President, Head of Oncology Development, Novartis 2019 to present – Executive Vice President, Chief Medical Officer, Global Drug Development Sandra Leung Executive Vice President, General Counsel Member of the Leadership Team 62 2015 to present – Executive Vice President, General Counsel Greg Meyers Executive Vice President, Chief Digital and Technology Officer Member of the Leadership Team 50 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 Elizabeth A.
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.
Executive Vice President, Chief Commercialization Officer Member of the Leadership Team 52 2015 to 2017 – President and Head of U.S. Commercial 2017 to 2018 – President and Head, International Markets 2018 to present – Executive Vice President, Chief Commercialization Officer David V.
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.
Removed
Mily Executive Vice President, Strategy & Business Development Member of the Leadership Team 55 2010 to 2020 – Managing Director, Barclays Investment Bank 2020 to present – Executive Vice President, Strategy & Business Development Ann M.
Added
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
Executive Vice President and President, Research Member of the Leadership Team 58 2015 to 2019 – President of Research and Early Development, Celgene Corporation 2019 to 2022 – Executive Vice President and President, Research and Early Development 2022 to present – Executive Vice President and President, Research Michelle Weese Executive Vice President, Corporate Affairs Member of the Leadership Team 52 2009 to 2018 – Founder/Chief Executive Officer, Strat-igence, Inc. 2018 to 2021 – General Secretary, North America, Danone 2021 to present – Executive Vice President, Corporate Affairs 33 PART II
Added
Executive 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.

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. 2017 2018 2019 2020 2021 2022 Bristol Myers Squibb $ 100.00 $ 87.10 $ 111.27 $ 111.72 $ 114.94 $ 136.75 S&P 500 100.00 95.62 125.72 148.85 191.58 156.88 Peer Group 100.00 110.03 129.02 131.63 162.01 179.43 34 Issuer Purchases of Equity Securities The following table summarizes the surrenders of our equity securities during the three months ended December 31, 2022: 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, 2022 11,337,688 $ 70.51 11,329,164 $ 8,669 November 1 to 30, 2022 13,988,212 78.23 13,963,667 7,577 December 1 to 31, 2022 5,150,025 79.98 5,095,948 7,169 Three months ended December 31, 2022 30,475,925 30,388,779 (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. 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.
(b) In May 2010, the Board of Directors authorized the repurchase of up to $3.0 billion of our common stock. Following this authorization, the Board subsequently approved additional authorizations, including most recently, in February 2020, January 2021 and December 2021, in the amount $5.0 billion, $2.0 billion and $15.0 billion, respectively, to the share repurchase authorization.
(b) In May 2010, the Board of Directors authorized the repurchase of up to $3.0 billion of our common stock. Following this authorization, the Board subsequently approved additional authorizations, including most recently, in February 2020, January and December 2021 and December 2023, in the amount $5.0 billion, $2.0 billion, $15.0 billion and $3.0 billion, respectively, to the share repurchase authorization.
Equity Compensation Plan Information Information required by this item will be contained in our 2023 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 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.
The graph assumes $100 investment on December 31, 2017 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, 2018, 2019, 2020, 2021 and 2022.
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.
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, 2023 was 32,895.
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.
The remaining share repurchase capacity under the program was approximately $7.2 billion as of December 31, 2022. Refer to “Item 1. Financial Statements—Note 17. Equity” for information on the share repurchase program. Item 6. [RESERVED] 35
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.
Added
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] 35 Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations 36 Item 7A. Quantitative and Qualitative Disclosures About Market Risk 64 Item 8. Financial Statements and Supplementary Data 66 Consolidated Statements of Earnings and Comprehensive (Loss)/Income 66 Consolidated Balance Sheets 67 Consolidated Statements of Cash Flows 68 Notes to the Financial Statements 69
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

Item 7. Management's Discussion & Analysis

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

132 edited+102 added−107 removed63 unchanged
Biggest changeGTN adjustments percentage increased primarily due to higher government channel mix, which has higher GTN adjustment percentages. 41 Product Revenues Year Ended December 31, Dollars in Millions 2022 2021 % Change In-Line Products Eliquis $ 11,789 $ 10,762 10 % U.S. 7,786 6,456 21 % Non-U.S. 4,003 4,306 (7) % Opdivo 8,249 7,523 10 % U.S. 4,812 4,202 15 % Non-U.S. 3,437 3,321 3 % Pomalyst/Imnovid 3,497 3,332 5 % U.S. 2,438 2,249 8 % Non-U.S. 1,059 1,083 (2) % Orencia 3,464 3,306 5 % U.S. 2,638 2,410 9 % Non-U.S. 826 896 (8) % Sprycel 2,165 2,117 2 % U.S. 1,497 1,297 15 % Non-U.S. 668 820 (19) % Yervoy 2,131 2,026 5 % U.S. 1,304 1,265 3 % Non-U.S. 827 761 9 % Empliciti 296 334 (11) % U.S. 185 200 (8) % Non-U.S. 111 134 (17) % Mature and other products 1,749 1,900 (8) % U.S. 565 580 (3) % Non-U.S. 1,184 1,320 (10) % New Product Portfolio Reblozyl 717 551 30 % U.S. 591 485 22 % Non-U.S. 126 66 91 % Abecma 388 164 ** U.S. 297 158 88 % Non-U.S. 91 6 ** Opdualag 252 — N/A U.S. 252 — N/A Non-U.S. — — N/A Zeposia 250 134 87 % U.S. 177 99 79 % Non-U.S. 73 35 ** 42 Year Ended December 31, % Change Dollars in Millions 2022 2021 2022 vs. 2021 Breyanzi 182 87 ** U.S. 151 84 80 % Non-U.S. 31 3 ** Onureg 124 73 70 % U.S. 95 69 38 % Non-U.S. 29 4 ** Inrebic 85 74 15 % U.S. 69 67 3 % Non-U.S. 16 7 ** Camzyos 24 — N/A U.S. 24 — N/A Non-U.S. — — N/A Sotyktu 8 — N/A U.S. 8 — N/A Non-U.S. — — N/A Recent LOE Products (a) Revlimid 9,978 12,821 (22) % U.S. 8,359 8,695 (4) % Non-U.S. 1,619 4,126 (61) % Abraxane 811 1,181 (31) % U.S. 580 898 (35) % Non-U.S. 231 283 (18) % Total Revenues 46,159 46,385 — U.S. 31,828 29,214 9 % Non-U.S. 14,331 17,171 (17) % ** Change in excess of 100%.
Biggest changeGTN adjustments percentage increased primarily due to continued pricing pressures. 44 Product Revenues Year Ended December 31, Dollars in millions 2023 2022 % Change In-Line Products Eliquis 12,206 $ 11,789 4 % U.S. 8,592 7,786 10 % Non-U.S. 3,614 4,003 (10) % Opdivo 9,009 8,249 9 % U.S. 5,283 4,812 10 % Non-U.S. 3,726 3,437 8 % Orencia 3,601 3,464 4 % U.S. 2,754 2,638 4 % Non-U.S. 847 826 3 % Pomalyst/Imnovid 3,441 3,497 (2) % U.S. 2,357 2,438 (3) % Non-U.S. 1,084 1,059 2 % Yervoy 2,238 2,131 5 % U.S. 1,388 1,304 6 % Non-U.S. 850 827 3 % Sprycel 1,930 2,165 (11) % U.S. 1,446 1,497 (3) % Non-U.S. 484 668 (28) % Mature and other products 1,895 2,045 (7) % U.S. 772 750 3 % Non-U.S. 1,123 1,295 (13) % Total In-Line Products 34,320 33,340 3 % U.S. 22,592 21,225 6 % Non-U.S. 11,728 12,115 (3) % 45 Year Ended December 31, Dollars in millions 2023 2022 % Change New Product Portfolio Reblozyl 1,008 717 41 % U.S. 811 591 37 % Non-U.S. 197 126 56 % Opdualag 627 252 * U.S. 617 252 * Non-U.S. 10 — N/A Abecma 472 388 22 % U.S. 358 297 21 % Non-U.S. 114 91 25 % Zeposia 434 250 74 % U.S. 324 177 83 % Non-U.S. 110 73 51 % Breyanzi 364 182 100 % U.S. 303 151 * Non-U.S. 61 31 97 % Camzyos 231 24 * U.S. 226 24 * Non-U.S. 5 — N/A Sotyktu 170 8 * U.S. 157 8 * Non-U.S. 13 — N/A Onureg 168 124 35 % U.S. 117 95 23 % Non-U.S. 51 29 76 % Inrebic 110 85 29 % U.S. 74 69 7 % Non-U.S. 36 16 * Augtyro 1 — N/A U.S. 1 — N/A Non-U.S. — — N/A Total New Product Portfolio 3,585 2,030 77 % U.S. 2,988 1,664 80 % Non-U.S. 597 366 63 % Total In-Line Products and New Product Portfolio 37,905 35,370 7 % U.S. 25,580 22,889 12 % Non-U.S. 12,325 12,481 (1) % 46 Year Ended December 31, Dollars in millions 2023 2022 % Change Recent LOE Products (a) Revlimid 6,097 9,978 (39) % U.S. 5,266 8,359 (37) % Non-U.S. 831 1,619 (49) % Abraxane 1,004 811 24 % U.S. 709 580 22 % Non-U.S. 295 231 28 % Total Recent LOE Products 7,101 10,789 (34) % U.S. 5,975 8,939 (33) % Non-U.S. 1,126 1,850 (39) % Total Revenues 45,006 46,159 (2) % U.S. 31,555 31,828 (1) % Non-U.S. 13,451 14,331 (6) % * Change in excess of 100%.
For a detailed listing of all specified items and further information, reconciliations and changes to our non-GAAP financial measures refer to “—Non-GAAP Financial Measures.” 36 Economic and Market Factors Governmental Actions Our products continue to be subject to increasing pressures across the portfolio from pharmaceutical market access and pricing controls and discounting, changes to tax and importation laws and other restrictions in the U.S., the EU and other regions around the world that result in lower prices, lower reimbursement rates and smaller populations for whom payers will reimburse, which can negatively impact our results of operations (including intangible asset impairment charges), operating cash flow, liquidity and financial flexibility.
For a detailed listing of all specified items and further information, reconciliations and changes to our non-GAAP financial measures refer to “—Non-GAAP Financial Measures.” Economic and Market Factors Governmental Actions Our products continue to be subject to increasing pressures across the portfolio from pharmaceutical market access and pricing controls and discounting, changes to tax and importation laws and other restrictions in the U.S., the EU and other regions around the world that result in lower prices, lower reimbursement rates and smaller populations for whom payers will reimburse, which can negatively impact our results of operations (including intangible asset impairment charges), operating cash flow, liquidity and financial flexibility.
These models required the use of the following significant estimates and assumptions among others: 56 • 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: • 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 procedures include a governance process to escalate to appropriate management levels potential questions or concerns regarding compliance with the policy and timely resolution of such questions or concerns. In addition, compliance with the policy is monitored on a regular basis. 54 We maintain DSAs with our U.S. pharmaceutical wholesalers, which account for nearly 100% of our gross U.S. revenues.
These procedures include a governance process to escalate to appropriate management levels potential questions or concerns regarding compliance with the policy and timely resolution of such questions or concerns. In addition, compliance with the policy is monitored on a regular basis. We maintain DSAs with our U.S. pharmaceutical wholesalers, which account for nearly 100% of our gross U.S. revenues.
Financial Statements and Supplementary Data—Note 1. Accounting Policies and Recently Issued Accounting Standards—Contingencies,” “—Note 7. Income Taxes” and “—Note 20. Legal Proceedings and Contingencies.” 58 Product and Pipeline Developments Our R&D programs are managed on a portfolio basis from early discovery through late-stage development and include a balance of early-stage and late-stage programs to support future growth.
Financial Statements and Supplementary Data—Note 1. Accounting Policies and Recently Issued Accounting Standards—Contingencies,” “—Note 7. Income Taxes” and “—Note 20. Legal Proceedings and Contingencies.” Product and Pipeline Developments Our R&D programs are managed on a portfolio basis from early discovery through late-stage development and include a balance of early-stage and late-stage programs to support future growth.
Legal Proceedings and Contingencies—Intellectual Property” for further information. 43 Opdivo (nivolumab) — a fully human monoclonal antibody that binds to the PD-1 on T and NKT cells that has been approved for several anti-cancer indications including bladder, blood, CRC, head and neck, RCC, HCC, lung, melanoma, MPM, stomach and esophageal cancer.
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.
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 2022 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 2023 Form 10-K for definitions of capitalized terms used throughout the document.
Excluding foreign exchange impacts, revenues decreased by 57%. • 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 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.
Under the current terms of the DSAs, our wholesaler customers provide us with weekly information with respect to months on hand product-level inventories and the amount of out-movement of products. The three largest wholesalers currently account for approximately 78% of our gross U.S. revenues.
Under the current terms of the DSAs, our wholesaler customers provide us with weekly information with respect to months on hand product-level inventories and the amount of out-movement of products. The three largest wholesalers currently account for approximately 85% of our gross U.S. revenues.
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 2022 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 2023 Form 10-K to enhance the understanding of our results of operations, financial condition and cash flows.
No forward-looking statement can be guaranteed. We have included important factors in the cautionary statements included in this 2022 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 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.
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 2022 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 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, 2022 is not available prior to the filing of this 2022 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.
Our late stage R&D programs in Phase III development include both investigational compounds for initial indications and additional indications or formulations for marketed products. Spending on these programs represents approximately 40% of our annual R&D expenses in the last three years.
Our late stage R&D programs in Phase III development include both investigational compounds for initial indications and additional indications or formulations for marketed products. Spending on these programs represents approximately 46% of our annual R&D expenses in the last three years.
The policy also requires that investments are only entered into with corporate and financial institutions that meet high credit quality standards. Refer to “Item 8. Financial Statements and Supplementary Data—Note 10. Financing Arrangements for further information.
The policy also requires that investments are only entered into with corporate and financial institutions that meet high credit quality standards. Refer to “Item 8. Financial Statements and Supplementary Data—Note 10. Financing Arrangements” for further information.
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 $101 million in 2022, $1.2 billion in 2021 and $1.1 billion in 2020.
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.
Opdivo was the only investigational compound or marketed product that represented greater than 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.
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.
We are able to leverage our leading capabilities in hematological malignancies and our robust pipeline to provide opportunities for long-term growth to offset the impact of current and future patent expires for Revlimid and Pomalyst .
We are able to leverage our leading capabilities in hematological malignancies and our robust pipeline to provide opportunities for long-term growth to offset the impact of current and future patent expiries for Revlimid and Pomalyst .
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 2022 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 2023 Form 10-K not to occur.
For example, on August 16, 2022, President Biden signed the IRA 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 coverage gap provisions 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 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 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 short-term ratings reflect the agencies’ opinion that we have good to extremely strong capacity for timely repayment.
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.
Refer to “—Product and Pipeline Developments” for all of the developments in our marketed products and late-stage pipeline in 2022 and in early 2023. 38 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 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.
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 $17.5 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 $14.6 billion that we would be obligated to pay upon achievement of certain sales levels in addition to royalties.
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 78% of total gross sales of U.S. products for the year ended December 31, 2022.
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.
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, business development and acquisitions, repurchase of common stock, debt maturities of approximately $10.6 billion through 2026, 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 $10.3 billion through 2028, as well as any debt repurchases through redemptions or tender offers.
The comparison of 2021 to 2020 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, 2021 “Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations” filed on February 10, 2021.
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.
These statements are likely to relate to, among other things, our goals, plans and objectives regarding our financial position, results of operations, cash flows, market position, product development, product approvals, sales efforts, expenses, performance or results of current and anticipated products, our business development strategy and in relation to our ability to realize the projected benefits of our acquisitions of Celgene, MyoKardia, and Turning Point, the impact of the COVID-19 pandemic on our operations and the development and commercialization of our products, potential laws and regulations to lower drug prices, market actions taken by private and government payers to manage drug utilization and contain costs, the expiration of patents or data protection on certain products, including assumptions about our ability to retain marketing exclusivity of certain products, and the outcome of contingencies such as legal proceedings and financial results.
These statements are likely to relate to, among other things, our goals, plans and objectives regarding our financial position, results of operations, cash flows, market position, product development, product approvals, sales efforts, expenses, performance or results of current and anticipated products, our business development strategy and in relation to our ability to realize the projected benefits of our acquisitions, alliances and other business development activities, the impact of any pandemic or epidemic on our operations and the development and commercialization of our products, potential laws and regulations to lower drug prices, market actions taken by private and government payers to manage drug utilization and contain costs, the expiration of patents or data protection on certain products, including assumptions about our ability to retain marketing exclusivity of certain products, and the outcome of contingencies such as legal proceedings and financial results.
Capital Expenditures Annual capital expenditures were approximately $1.1 billion in 2022, $970 million in 2021 and $750 million in 2020 and are expected to be approximately $1.2 billion in 2023 and 2024. 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 $1.1 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.
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) divestiture gains or losses, (vii) stock compensation resulting from acquisition-related equity awards, (viii) pension, legal and other contractual settlement charges, (ix) equity investment and contingent value rights fair value adjustments (including fair value adjustments attributed to limited partnership equity method investments) and (x) 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) 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.
The Opdivo + Yervoy regimen also is approved in multiple markets for the treatment of NSCLC, melanoma, MPM, RCC, CRC and esophageal cancer. • U.S. revenues increased 3% in 2022 due to higher average net selling prices. • International revenues increased 9% in 2022 due to higher demand as a result of additional indication launches and core indications, partially offset by foreign exchange impacts of 12% and lower average net selling prices.
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%.
We are committed to an aggregate $22.0 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 $7.5 billion (milestones achieved through Phase III clinical studies) and late-stage milestones of $14.5 billion (milestones achieved post Phase III clinical studies).
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 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.
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.
Furthermore, countries are expected to make changes to their tax laws and updates to international tax treaties to implement the agreement by the Organization for Economic Co-operation and Development to establish a global minimum tax. See risk factors on these items included under “Part I—Item 1A.
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.
Refer to “Item 8. Financial Statements and Supplementary Data—Note 10. "Financing Arrangements” for further information. • Royalties increased in 2022 primarily due to higher Keytruda * and diabetes business divestiture 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. • Royalties increased in 2023 primarily due to higher Keytruda * royalties. Refer to “Item 8. Financial Statements and Supplementary Data—Note 4.
The share repurchase program does not obligate us to repurchase any specific number of shares nor does it have a specific expiration date and may be suspended or discontinued at any time. In 2022, we repurchased approximately 109 million shares of our common stock for $8.0 billion, including approximately 69 million shares for $5.0 billion through our ASR program.
The share repurchase program does not obligate us to repurchase any specific number of shares nor does it have a specific expiration date and may be suspended or discontinued at any time. In 2023, we repurchased approximately 87 million shares of our common stock for $5.2 billion, including approximately 70 million shares for $4.0 billion through our ASR agreements.
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 2023. The foreign and state net operating loss carryforwards expire in varying amounts beginning in 2023 (certain amounts have unlimited lives).
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.
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 increased 15% in 2022 due to higher average net selling prices and higher demand. • International revenues decreased 19% in 2022 due to foreign exchange impacts of 11% and lower demand as a result of generic erosion.
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%.
Our deferred tax assets were $4.1 billion at December 31, 2022 (net of valuation allowance of $873 million) and $2.7 billion at December 31, 2021 (net of valuation allowance of $1.1 billion). The U.S. federal net operating loss carryforwards were $709 million at December 31, 2022.
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.
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. 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.
June 2022 Announced three-year follow up results from the Phase III CheckMate -9LA trial demonstrating long-term, durable survival benefits with Opdivo plus Yervoy with two cycles of chemotherapy compared to four cycles of chemotherapy in patients with previously untreated metastatic NSCLC regardless of PD-L1 expression and histology.
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.
Excluding foreign exchange impacts, revenues increased by 8%.
Excluding foreign exchange impacts, revenues increased by 5%.
Excluding foreign exchange impacts, revenues decreased by 5%.
Excluding foreign exchange impacts, revenues decreased by 11%.
Onureg (azacitidine) — an oral hypomethylating agent that incorporates into DNA and RNA, indicated for continued treatment of adult patients with AML who achieved first complete remission or complete remission with incomplete blood count recovery following intensive induction chemotherapy and are not able to complete intensive curative therapy. Onureg was launched in September 2020.
Onureg (azacitidine) — an oral hypomethylating agent that incorporates into DNA and RNA, indicated for continued treatment of adult patients with AML who achieved first complete remission or complete remission with incomplete blood count recovery following intensive induction chemotherapy and are not able to complete intensive curative therapy. • U.S. revenues increased 23% in 2023 primarily due to higher demand.
Camzyos was launched in April 2022. Sotyktu (deucravacitinib) — 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 was launched in September 2022.
Camzyos (mavacamten) — a cardiac myosin inhibitor indicated for the treatment of adults with symptomatic obstructive HCM to improve functional capacity and symptoms. Camzyos was launched in April 2022. Sotyktu (deucravacitinib) — 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 reductions to provisions in 2022 primarily related to Non-U.S. revisions in clawback amounts primarily driven by the VAT recoverable estimates in 2022 and Eliquis coverage gap discounts in 2021. GTN adjustments are primarily a function of product sales volume, regional and payer channel mix, contractual or legislative discounts and rebates. U.S.
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.
Acquisitions, Divestitures, Licensing and Other Arrangements.” RESULTS OF OPERATIONS Regional Revenues The composition of the changes in revenues was as follows: Year Ended December 31, 2022 vs. 2021 Dollars in Millions 2022 2021 % Change Foreign Exchange (b) United States $ 31,828 $ 29,214 9 % — International 13,497 16,319 (17) % (9) % Other (a) 834 852 (2) % — Total $ 46,159 $ 46,385 — (3) % (a) Other revenues include royalties and alliance-related revenues for products not sold by our regional commercial organizations.
Acquisitions, Divestitures, Licensing and Other Arrangements.” 42 RESULTS OF OPERATIONS Regional Revenues The composition of the changes in revenues was as follows: Year Ended December 31, Dollars in millions 2023 2022 % Change Foreign Exchange (b) United States $ 31,555 $ 31,828 (1) % N/A International 12,752 13,497 (6) % (1) % Other (a) 699 834 (16) % N/A Total $ 45,006 $ 46,159 (2) % — % (a) Other revenues include royalties and alliance-related revenues for products not sold by our regional commercial organizations.
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.
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.
Income Taxes Year Ended December 31, Dollars in Millions 2022 2021 Earnings Before Income Taxes $ 7,713 $ 8,098 Provision for Income Taxes 1,368 1,084 Effective Tax Rate 17.7 % 13.4 % Impact of Specified Items (2.4) % 2.6 % Effective Tax Rate Excluding Specified Items 15.3 % 16.0 % The income tax impact attributed to the GAAP effective tax rate includes the impact from specified items summarized in the following “—Non-GAAP Financial Measures” section.
Restructuring.” Income Taxes Year Ended December 31, Dollars in millions 2023 2022 Earnings Before Income Taxes $ 8,440 $ 7,713 Provision for Income Taxes 400 1,368 Effective Tax Rate 4.7 % 17.7 % Impact of Specified Items 10.0 % (2.4) % Effective Tax Rate Excluding Specified Items 14.7 % 15.3 % The effective tax rate decreased from 17.7% to 4.7% primarily due to the impact of specified items summarized in the following “—Non-GAAP Financial Measures” section.
No borrowings were outstanding under any revolving credit facility at December 31, 2022 or 2021. 52 Our investment portfolio includes marketable debt securities, which are subject to changes in fair value as a result of interest rate fluctuations and other market factors. Our investment policy establishes limits on the amount and time to maturity of investments with any institution.
Our investment portfolio includes marketable debt securities, which are subject to changes in fair value as a result of interest rate fluctuations and other market factors. Our investment policy establishes limits on the amount and time to maturity of investments with any institution.
Empliciti (elotuzumab) — a humanized monoclonal antibody for the treatment of multiple myeloma. 44 Mature and other products — includes all other products, including those which have lost exclusivity in major markets, OTC products and royalty revenue and mature products. • International revenues for mature and other products decreased 10% due to lower demand as a result of a continued generic erosion and foreign exchange impacts of 5%.
Mature and other products — includes all other products, including those which have lost exclusivity in major markets, OTC products and royalty revenue and mature products. • International revenues for mature and other products decreased 13% primarily due to lower demand as a result of continued generic erosion and foreign exchange impacts of 2%.
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. • U.S. revenues increased 9% in 2022 due to higher demand. • International revenues decreased 8% in 2022 due to foreign exchange impacts of 11%, partially offset by higher demand.
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%.
If the assets in a transaction include an input and a substantive process that together significantly contribute to the ability to create outputs, the transaction is treated as an acquisition of a business. Our assessments concluded that the Turning Point transaction was a business combination in 2022 and the MyoKardia transaction in 2020 was an asset acquisition.
If the assets in a transaction include an input and a substantive process that together significantly contribute to the ability to create outputs, the transaction is treated as an acquisition of a business.
For purposes of comparability, the non-GAAP financial measures for the year ended December 31, 2021, have been updated to reflect this change. 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, analysts and investors’ overall understanding of our underlying financial performance and facilitate comparisons among current, past and future periods.
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 8% in 2022 due to higher average net selling prices and higher demand. • International revenues decreased 2% in 2022 due to foreign exchange impacts of 10% and lower average net selling prices, partially offset by higher demand.
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%.
We will disclose any product with levels of inventory in excess of one month on hand or expected demand, subject to a de minimis exception, in the next quarterly report on Form 10-Q. 46 Expenses Year Ended December 31, % Change Dollar in Millions 2022 2021 2022 vs 2021 Cost of products sold (a) $ 10,137 $ 9,940 2 % Marketing, selling and administrative 7,814 7,690 2 % Research and development 9,509 10,195 (7) % Acquired IPRD 815 1,159 (30) % Amortization of acquired intangible assets 9,595 10,023 (4) % Other (income)/expense, net 576 (720) ** Total Expenses $ 38,446 $ 38,287 — ** 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. 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%.
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. 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.
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.
The evolution in our operating model, which focuses on maintaining a disciplined approach in marketing, selling and administrative expenses, will enable us to deliver the necessary strategic, financial and operational flexibility to invest in the highest priority opportunities within our portfolio.
The evolution in our operating model, which focuses on maintaining a disciplined approach in marketing, selling and administrative expenses, will enable us to deliver the necessary strategic, financial and operational flexibility to invest in the highest priority opportunities within our portfolio. 41 Our strategy extends well beyond the discovery, development and delivery of transformative medicines that help patients prevail over serious diseases.
Other (income)/expense, net Other (income)/expense, net changed by $1.3 billion in 2022, primarily due to equity investments, contingent value rights and other items discussed below.
Other (income)/expense, net Other (income)/expense, net changed by $1.7 billion primarily due to litigation and other settlements, equity investments and other items discussed below.
Excluding foreign exchange impacts, revenues increased by 4%. • Following the May 2021 expiration of regulatory exclusivity for Eliquis in Europe, and court decisions in (i) the United Kingdom finding the UK apixaban composition of matter patent and related SPC invalid and (ii) the Netherlands denying a BMS request for a preliminary injunction that would have prevented an at-risk generic launch, generic manufacturers have begun marketing generic versions of Eliquis in the UK and the 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 our Eliquis patents being filed in various countries in Europe.
Excluding foreign exchange impacts, revenues decreased by 10%. • Following the May 2021 expiration of regulatory exclusivity for Eliquis in Europe and the court decision in the UK finding the UK apixaban composition-of-matter patent and related SPC invalid, generic manufacturers have begun marketing generic versions of Eliquis in the UK and in Portugal, and may seek to market generic versions of Eliquis in additional countries in Europe, prior to the expiration of our patents, which has led to additional infringement and invalidity actions involving our Eliquis patents being filed in various countries in Europe.
Certain other significant tax items are also excluded such as the impact resulting from 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. We also provide international revenues for our priority products excluding the impact of foreign exchange.
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.
Reblozyl (luspatercept-aamt) — an erythroid maturation agent indicated for the treatment of anemia in adult patients with beta thalassemia who require regular red blood cell transfusions and for the treatment of anemia failing an ESA in adult patients with very low- to intermediate-risk MDS who have ring sideroblasts and require RBC transfusions. • U.S. revenues increased 22% in 2022 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 ring sideroblast status. • U.S. revenues increased 37% in 2023 primarily due to higher demand.
Components of Other (income)/expense, net were as follows: Year Ended December 31, Dollars in Millions 2022 2021 Interest expense $ 1,232 $ 1,334 Royalty and licensing income (1,283) (1,067) Royalty income - divestitures (832) (666) Equity investment losses/(income), net 801 (745) Integration expenses 440 564 Loss on debt redemption 266 281 Divestiture gains (211) (9) Litigation and other settlements 178 82 Investment income (171) (39) Provision for restructuring 75 169 Contingent consideration (9) (542) Other 90 (82) Other (income)/expense, net $ 576 $ (720) 48 • Interest expense decreased in 2022 due to additional debt maturities.
Year Ended December 31, Dollars in millions 2023 2022 Interest expense $ 1,166 $ 1,232 Royalty and licensing income (1,488) (1,283) Royalty income - divestitures (862) (832) Equity investment losses/(income), net 160 801 Integration expenses 242 440 Loss on debt redemption — 266 Divestiture gains — (211) Litigation and other settlements (390) 178 Investment income (449) (171) Provision for restructuring 365 75 Contingent consideration (8) (9) Other 106 90 Other (income)/expense, net $ (1,158) $ 576 • Interest expense decreased in 2023 due to additional debt maturities.
The approval is based on the results from the Phase III POETYK PSO-1 trial. September 2022 Announced FDA approval of Sotyktu for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. The approval is based on results from the Phase III POETYK PSO-1 and POETYK PSO-2 clinical trials.
March 2023 Announced EC approval of Sotyktu for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy. The approval was based on Phase III POETYK PSO-1 and POETYK PSO-2 clinical trials as well as additional data from the POETYK PSO long-term extension trial.
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. Expenses typically vary between periods for a number of reasons, including the timing of IPRD impairment charges.
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.
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: Year Ended December 31, 2022 Dollars in Millions Charge-Backs and Cash Discounts Medicaid and Medicare Rebates Other Rebates, Returns, Discounts and Adjustments Total Balance at January 1, 2022 $ 723 $ 3,206 $ 3,193 $ 7,122 Provision related to sales made in: Current period 7,483 11,364 6,344 25,191 Prior period (14) (2) (213) (229) Payments and returns (7,511) (10,746) (6,319) (24,576) Foreign currency translation and other (6) — (125) (131) Balance at December 31, 2022 $ 675 $ 3,822 $ 2,880 $ 7,377 40 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 2022 2021 2022 vs. 2021 Gross product sales $ 69,633 $ 67,897 3 % GTN Adjustments Charge-backs and cash discounts (7,469) (7,253) 3 % Medicaid and Medicare rebates (11,362) (9,374) 21 % Other rebates, returns, discounts and adjustments (6,131) (6,215) (1) % Total GTN Adjustments (24,962) (22,842) 9 % Net product sales $ 44,671 $ 45,055 (1) % GTN adjustments percentage 36 % 33 % 3 % U.S. 41 % 40 % 1 % Non-U.S. 17 % 17 % — Reductions to provisions for product sales made in prior periods resulting from changes in estimates were $229 million and $319 million for 2022 and 2021, 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, 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.
We believe in the innovative science behind Eliquis and the strength of our intellectual property, which we will defend against infringement. Refer to “Item 1. Financial Statements—Note 20.
Most recently, in France, Norway and Sweden, courts held in BMS's favor, confirming the validity of the composition of matter patent and related SPCs in those countries. We believe in the innovative science behind Eliquis and the strength of our intellectual property, which we will defend against infringement. Refer to “Item 1. Financial Statements—Note 20.
Acquired IPRD charges are detailed in the table below. 47 Year Ended December 31, Dollars in Millions 2022 2021 Mavacamten royalty extinguishment $ 295 $ — Dragonfly milestone and opt-in license fee 200 — Immatics upfront license fee 150 — BridgeBio upfront collaboration fee 90 — Eisai upfront collaboration fee — 650 Agenus upfront license fee and milestone — 220 Prothena opt-in license fee — 80 Evotec opt-in license fee — 58 Other 80 151 Acquired IPRD $ 815 $ 1,159 Refer to “Item 8.
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.
Our priorities are to continue to renew and diversify our portfolio through launching new medicines, advancing our early, mid and late-stage pipeline, and executing disciplined business development. We remain committed to maintaining a strong investment grade credit rating and returning capital to shareholders.
Our priorities are (i) to continue to renew and diversify our portfolio through launching new medicines, (ii) advancing our early, mid and late-stage pipeline and (iii) executing disciplined business development.
Financial Instruments and Fair Value Measurements” for more information. • Integration expenses decreased in 2022 due to lower consulting fees to implement Celgene integration initiatives related to processes and systems. • Loss on debt redemption resulted from the early redemption of long-term debt of $6.0 billion in 2022 and $3.5 billion in 2021. • Divestiture gains resulted from certain mature product rights divested in 2022. • Investment income increased in 2022 primarily due to higher interest rates. • Litigation and other settlements includes amounts related to commercial disputes regarding licensing and supply obligation matters, intellectual property and promotional practice matters.
Financial Instruments and Fair Value Measurements” for more information. • Integration expenses decreased in 2023 due to lower consulting fees to implement Celgene integration initiatives related to processes and systems. • Loss on debt redemption resulted from the early redemption of long-term debt of $6.0 billion in 2022. • Divestiture gains resulted from certain mature product rights divested in 2022. • Investment income increased in 2023 primarily due to higher interest rates. 53 • Litigation and other settlements in 2023 include $384 million of income related to the AZ settlement and $400 million of income related to the Nimbus' TYK2 program change of control provision, partially offset by $322 million expense recorded in connection with the BeiGene settlement.
The $524 million change in cash flow from investing activities compared to 2021 was primarily due to the acquisition of Turning Point ($3.2 billion, net of cash acquired), lower proceeds from the sale of equity investments ($2.4 billion), partially offset by the changes in the amount of marketable debt securities held ($4.1 billion), lower Acquired IPRD payments ($646 million) and higher proceeds from divestitures ($557 million).
The $1.2 billion increase in cash flow used in investing activities compared to 2022 resulted from $3.9 billion of changes in the amount of marketable debt securities held and $396 million of lower divestiture proceeds, partially offset by the acquisition of Turning Point ($3.2 billion net of cash acquired) in 2022.
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.
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.
Abecma (idecabtagene vicleucel) — is a B-cell maturation antigen-directed 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-CD38 monoclonal antibody. Abecma was launched in May 2021.
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.
Data demonstrated favorable risk-benefit profile supportive of progressing into Phase III. 63 Special Note Regarding Forward-Looking Statements This 2022 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.
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.
The application is based on results from the Phase III CheckMate-816 trial. March 2022 Announced FDA approval of Opdivo in combination with platinum-doublet chemotherapy for the treatment of adult patients with resectable NSCLC in the neoadjuvant setting. The approval is based on the Phase III CheckMate-816 trial.
NSCLC June 2023 Announced EC approval of Opdivo in combination with platinum-based chemotherapy for the neoadjuvant treatment of resectable NSCLC at a high risk of recurrence in adult patients with tumor cell PD-L1 expression > 1%. The approval is based on results from the Phase III CheckMate -816 trial.
January 2022 Announced Japan's Ministry of Health, Labour and Welfare approval of Abecma for the treatment of adult patients with relapsed or refractory multiple myeloma, who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody, and have either experienced disease progression on the last therapy or relapse after the last therapy.
December 2023 Announced that Japan's Ministry of Health, Labour and Welfare granted manufacturing and marketing approval of the supplemental New Drug Application for an additional indication for Abecma for patients with relapsed or refractory multiple myeloma who have received at least two prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody.
The safety profile was consistent with previously reported studies of the Opdivo plus Yervoy combination in solid tumors. NSCLC June 2022 Announced five-year follow up results from Part I of the Phase III CheckMate -227 trial demonstrating long-term, durable survival outcomes with Opdivo plus Yervoy in first-line treatment of patients with metastatic NSCLC regardless of PD-L1 expression levels.
NSCLC September 2023 Announced six-year results from the Phase III CheckMate -227 trial demonstrating long-term, durable survival benefits of Opdivo plus Yervoy compared to chemotherapy in the first-line treatment of patients with metastatic NSCLC, regardless of PD-L1 expression levels.
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. Reconciliations of these non-GAAP measures to the most comparable GAAP measures are included in Exhibit 99.2 to our Form 8-K filed on February 2, 2023 and are incorporated herein by reference.
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.
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.
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.
June 2022 Announced FDA approval of Breyanzi for the second-line treatment of adult patients with large B-cell lymphoma, including diffuse large B-cell lymphoma not otherwise specified high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma and follicular lymphoma grade 3B who have: refractory disease to first line chemoimmunotherapy or relapsed within 12 months of first-line chemoimmunotherapy; or refractory disease to first-line chemoimmunotherapy or relapse after first-line chemoimmunotherapy and are not eligible for hematopoietic stem cell transplant due to comorbidities or age.
May 2023 Announced EC approval of Breyanzi for the treatment of adult patients with diffuse large B-cell lymphoma, high grade B-cell lymphoma, primary mediastinal large B-cell lymphoma and FL grade 3B, who relapsed within 12 months from completion of, or are refractory to, first-line chemoimmunotherapy.
As of December 31, 2022, we had a five-year $5.0 billion revolving credit facility expiring in January 2027, which is extendable annually by one year with the consent of the lenders. This facility provides for customary terms and conditions with no financial covenants and may be used to provide backup liquidity for our commercial paper borrowings.
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.

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Item 7A. Quantitative and Qualitative Disclosures About Market Risk

Market Risk — interest-rate, FX, commodity exposure

9 edited+0 added−1 removed6 unchanged
Biggest changeNon-U.S. dollar borrowings are used to hedge the foreign currency exposures of our net investment in certain international affiliates and are designated as hedges of net investments. The effective portion of foreign exchange gains or losses on these hedges is included in the foreign currency translation component of Accumulated other comprehensive loss.
Biggest changeForeign currency forward contracts are also used to hedge the foreign currency exposures of our net investment in certain international affiliates and are designated as hedges of net investments.
We use cross-currency interest rate swap contracts designated to manage risk arising from long-term debt denominated in euros and to hedge the Company's net investment in its foreign subsidiaries. The fair values of these contracts as well as our marketable debt securities are analyzed at year-end to determine their sensitivity to interest rate changes.
We use cross-currency swap contracts designated to manage risk arising from long-term debt denominated in euros and to hedge the Company's net investment in its foreign subsidiaries. The fair values of these contracts as well as our marketable debt securities are analyzed at year-end to determine their sensitivity to interest rate changes.
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.” 65
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
In this sensitivity analysis, if there was a 1% increase in short-term or long-term interest rates as of December 31, 2022 and December 31, 2021, 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, 2023 and December 31, 2022, the expected adverse impact on our earnings would not be material.
Cross-currency interest rate swap contracts are used to manage risk arising from long-term debt denominated in euros and to hedge the Company's net investment in its foreign subsidiaries.
Cross-currency swap contracts are used to manage risk arising from long-term debt denominated in euros and to hedge the Company's net investment in its foreign subsidiaries.
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 $782 million and $678 million as of December 31, 2022 and December 31, 2021, 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 $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 an increase of 1% in long-term interest rates as of December 31, 2022 and December 31, 2021 would decrease the fair value of long-term debt by $2.6 billion and $3.8 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, 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.
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.
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.
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 cross-currency interest swap contracts by $73 million and $58 million as of December 31, 2022 and December 31, 2021. 64 We are also exposed to translation risk on non-U.S. dollar-denominated net assets.
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 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.
Removed
If our net investment decreases below the equivalent value of the non-U.S. debt borrowings, the change in the remeasurement basis of the debt would be subject to recognition in income as changes occur. For additional information, refer to “Item 8. Financial Statements and Supplementary Data—Note 9.

Other BMY 10-K year-over-year comparisons