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What changed in Amgen's 10-K — 2024 vs 2025

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Paragraph-level year-over-year comparison of Amgen's 2024 and 2025 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 2025 report.

+665 added−641 removedSource: 10-K (2026-02-13) vs 10-K (2025-02-14)

Top changes in Amgen's 2025 10-K

665 paragraphs added · 641 removed · 497 edited across 8 sections

Item 1. Business

Business — how the company describes what it does

149 edited+55 added−44 removed127 unchanged
Biggest changeInvestigational indications (programs) Phase 3 AMJEVITA Interchangeability Bemarituzumab Gastric and gastroesophageal junction cancer BLINCYTO Ph-negative B-ALL 17 Investigational indications (programs) Dazodalibep Sjögren’s disease EVENITY Male osteoporosis IMDELLTRA Small cell lung cancer LUMAKRAS/LUMYKRAS Advanced colorectal cancer Non-small cell lung cancer Nplate Chemotherapy-induced thrombocytopenia Olpasiran Cardiovascular disease Otezla Palmoplantar pustulosis Repatha Cardiovascular disease Rocatinlimab Moderate-to-severe atopic dermatitis Prurigo nodularis TEPEZZA Subcutaneous administration for TED Chronic/low clinical activity score TED in Japan TEZSPIRE Chronic rhinosinusitis with nasal polyps Eosinophilic esophagitis Severe asthma UPLIZNA Generalized myasthenia gravis IgG4-related disease Xaluritamig Metastatic castrate resistant prostate cancer ABP 206 Investigational biosimilar to OPDIVO (nivolumab) ABP 234 Investigational biosimilar to KEYTRUDA (pembrolizumab) ABP 692 Investigational biosimilar to OCREVUS (ocrelizumab) Phase 2 Bemarituzumab Other tumors Blinatumomab Systemic lupus erythematosus with nephritis Daxdilimab Dermatomyositis and anti-synthetase inflammatory myositis Discoid lupus erythematosus Inebilizumab Systemic lupus erythematosus with nephritis LUMAKRAS/LUMYKRAS Other tumors Maridebart cafraglutide Obesity Type 2 diabetes Ordesekimab Celiac disease Rocatinlimab Moderate-to-severe asthma TEZSPIRE Chronic obstructive pulmonary disease AMG 104 Asthma AMG 193 Non-small cell lung cancer AMG 329 Sjögren’s disease Phase 1 IMDELLTRA Neuroendocrine prostate cancer Xaluritamig Prostate cancer AMG 193 Solid tumors AMG 305 Solid tumors AMG 355 Solid tumors AMG 513 Obesity AMG 651 Solid tumors 18 Investigational indications (programs) AMG 691 Asthma AMG 732 TED Phase 3 Clinical trials investigate the short- and long-term safety and efficacy of our product candidates, compared to commonly used treatments, in a large number of patients who have the disease or condition under study.
Biggest changeInvestigational indications (programs) Phase 3 BLINCYTO Ph-negative B-ALL Dazodalibep Sjögren’s disease IMDELLTRA/IMDYLLTRA Small cell lung cancer LUMAKRAS/LUMYKRAS Metastatic colorectal cancer Non-small cell lung cancer MariTide Chronic weight management Cardiovascular disease Heart failure Obstructive sleep apnea Nplate Chemotherapy-induced thrombocytopenia Olpasiran Cardiovascular disease Pegloticase Subcutaneous administration for uncontrolled gout Repatha Cardiovascular disease Rocatinlimab (1) Moderate-to-severe atopic dermatitis Prurigo nodularis TEPEZZA Subcutaneous administration for TED Chronic/low clinical activity score TED in Japan TEZSPIRE Chronic obstructive pulmonary disease Eosinophilic esophagitis Xaluritamig Metastatic castrate resistant prostate cancer ABP 206 Investigational biosimilar to OPDIVO ® (nivolumab) ABP 234 Investigational biosimilar to KEYTRUDA ® (pembrolizumab) ABP 692 Investigational biosimilar to OCREVUS ® (ocrelizumab) 19 Investigational indications (programs) Phase 2 Blinatumomab Refractory rheumatoid arthritis Systemic lupus erythematosus with and without nephritis Daxdilimab Dermatomyositis and anti-synthetase inflammatory myositis Discoid lupus erythematosus Inebilizumab Systemic lupus erythematosus with nephritis MariTide Type 2 diabetes Rocatinlimab (1) Moderate-to-severe asthma AMG 104 Asthma AMG 193 Non-small cell lung cancer AMG 329 Sjögren’s disease AMG 732 TED Phase 1 Xaluritamig Ewing Sarcoma AMG 193 Other tumors AMG 305 Solid tumors AMG 355 Solid tumors AMG 410 Solid tumors AMG 513 Obesity AMG 691 Asthma (1) See Significant Developments for additional information regarding the termination of our collaboration agreement with Kyowa Kirin.
We perform various procedures to help authenticate the sources of raw materials, including intermediary materials used in the manufacture of our products; the procedures include verification of country of origin and are incorporated into the manufacturing processes we and our third-party contract manufacturers perform.
We perform various procedures to help authenticate the sources of raw materials, including intermediary materials used in the manufacture of our products; the procedures are incorporated into the manufacturing processes we and our third-party contract manufacturers perform and include verification of country of origin.
Bradway has been a director of The Boeing Company, an aerospace company and manufacturer of commercial airplanes and defense, space, and securities systems, since 2016. He has served on the board of trustees of the University of Southern California since 2014. Dr. James E.
Bradway has been a director of The Boeing Company, an aerospace company and manufacturer of commercial airplanes, defense, space and securities systems, since 2016. He has served on the board of trustees of the University of Southern California since 2014. Dr. James E.
Typically, we undertake an FDA-designated three-phase human clinical testing program. 13 • In phase 1, we conduct small clinical trials to investigate the safety and proper dose ranges of our product candidates in a small number of human subjects. • In phase 2, we conduct clinical trials to investigate side-effect profiles and the efficacy of our product candidates in a patient population larger than phase 1 but still relatively small, who have the disease or condition under study. • In phase 3, we conduct clinical trials to investigate the short- and long-term safety and efficacy of our product candidates, compared to commonly used treatments, in a large number of patients who have the disease or condition under study.
Typically, we undertake an FDA-designated three-phase human clinical testing program. • In Phase 1, we conduct small clinical trials to investigate the safety and proper dose ranges of our product candidates in a small number of human subjects. • In Phase 2, we conduct clinical trials to investigate side-effect profiles and the efficacy of our product candidates in a patient population larger than Phase 1 but still relatively small, who have the disease or condition under study. • In Phase 3, we conduct clinical trials to investigate the short- and long-term safety and efficacy of our product candidates, compared to commonly used treatments, in a large number of patients who have the disease or condition under study.
For example, our facility in North Carolina and our FDA-approved facility in Ohio contain many examples of environmental commitments, including on-site photovoltaic renewable energy generation at both sites. We expect our North Carolina facility’s carbon footprint, water usage and waste disposed to be substantially lower than that of a traditional drug substance manufacturing plant.
For example, our facility in North Carolina and our FDA-approved facility in Ohio contain many examples of environmental commitments, including on-site photovoltaic renewable energy generation at both sites. We expect our North Carolina facility’s carbon footprint, water usage and waste disposed to be substantially lower than that of a traditional drug substance manufacturing facility.
In highly competitive treatment markets such as the markets for ENBREL, Otezla, Repatha and Aimovig, PBMs are also able to exert negotiating leverage by requiring incremental rebates from manufacturers in order for them to gain and/or maintain their formulary position.
In highly competitive treatment markets such as the markets for ENBREL, Otezla, Repatha and 11 Aimovig, PBMs are also able to exert negotiating leverage by requiring incremental rebates from manufacturers in order for them to gain and/or maintain their formulary position.
We provide job-specific safety training tailored to each role, and to foster our safety culture, we implement a comprehensive safety program and reinforce desired safety behaviors, driving to understand and mitigate the root cause of 24 safety incidents and manage and control variability.
We provide job-specific safety training tailored to each role, and to foster our safety culture, we implement a comprehensive safety program and reinforce desired safety behaviors, driving to understand and mitigate the root cause of safety incidents and manage and control variability.
Our new state-of-the-art biomanufacturing plants, including our facility in North Carolina and FDA-approved facility in Ohio, have been constructed at a lower cost and with greater speed as compared to traditional facilities.
Our new state-of-the-art biomanufacturing facilities, including our facility in North Carolina and FDA-approved facility in Ohio, have been constructed at a lower cost and with greater speed as compared to traditional facilities.
Violations of fraud and abuse laws may be punishable by criminal and/or civil sanctions, including fines and civil monetary penalties, as well as by the possibility of exclusion from federal healthcare programs (including Medicare and Medicaid).
Violations of fraud and abuse laws may be punishable by criminal and/or civil sanctions, including fines and civil monetary penalties, as well as by the possibility 17 of exclusion from federal healthcare programs (including Medicare and Medicaid).
Risk Factors— We currently face competition from biosimilars and generics and expect to face increasing competition from biosimilars and generics in the future . Regulation of Product Marketing and Promotion . The FDA regulates the marketing and promotion of drug products.
Risk Factors— We currently face competition from biosimilars and generics and expect to face increasing competition from biosimilars and generics in the future . 15 Regulation of Product Marketing and Promotion . The FDA regulates the marketing and promotion of drug products.
Outside of the United States, some of our employees are represented by unions or works councils. We consider our staff relations to be good, supported by regular assessments of staff engagement surveys on a wide range of topics (including flexible work environments, career development, and maintaining a culture of compliance). Our engagement scores were above general market benchmarks in 2024.
Outside of the United States, some of our employees are represented by unions or works councils. We consider our staff relations to be good, supported by regular assessments of staff engagement surveys on a wide range of topics (including flexible work environments, career development, and maintaining a culture of compliance). Our engagement scores were above general market benchmarks in 2025.
See Government Regulation— Clinical Development and Product Approval section above. Our discovery research programs may therefore yield targets that lead to the development of human therapeutics delivered as large molecules, small molecules, other combination modalities or new modalities. We have reshaped our portfolio and have increasingly focused our efforts on human genetics when possible to enhance the likelihood of success.
See Government Regulation— Clinical Development and Product Approval section above. Our discovery research programs may therefore yield targets that lead to the development of human therapeutics delivered as large molecules, small molecules, other combination modalities or new modalities. We have increasingly focused our efforts on human genetics when possible to enhance the likelihood of success.
We focus on areas of high unmet medical need and leverage our expertise to strive for solutions that dramatically improve people’s lives, while also reducing the social and economic burden of disease. We helped launch the biotechnology industry more than 40 years ago and have grown to be one of the world’s leading independent biotechnology companies.
We focus on areas of high unmet medical need and leverage our expertise to strive for solutions that dramatically improve people’s lives, while also reducing the social and economic burden of disease. We helped launch the biotechnology industry more than 45 years ago and have grown to be one of the world’s leading independent biotechnology companies.
Together with our collaborators, we market our products to healthcare providers, including physicians or their clinics, dialysis centers, hospitals and pharmacies. In the United States, substantially all of our sales are to pharmaceutical wholesale distributors, which is the principal means of distributing our products to healthcare providers. We market certain products through direct-to-consumer channels, including print, television and online media.
Together with our collaborators, we market our products to healthcare providers, including physicians or their clinics, dialysis centers, hospitals and pharmacies. In the United States, substantially all of our sales are to pharmaceutical wholesale distributors, which is the principal means of distributing our products to healthcare providers. We market certain products through direct-to-patient channels, including print, television and online media.
Vectibix was launched in 2006 and is indicated for the treatment of patients with wild-type RAS metastatic colorectal cancer (mCRC, cancer that has spread outside the colon and rectum) and in the United States, in combination with LUMAKRAS, for the treatment of adult patients with KRAS G12C-mutated mCRC, who have received prior fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy.
Vectibix was launched in 2006 and is indicated for the treatment of patients with wild-type RAS metastatic colorectal cancer (mCRC, which is a cancer that has spread outside the colon and rectum) and in the United States, in combination with LUMAKRAS, for the treatment of adult patients with KRAS G12C-mutated mCRC, who have received prior fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy.
Our business has been and will continue to be subject to various other U.S. and foreign laws, rules and regulations, including provisions of the IRA. See Reimbursement section above. 16 Research and Development and Selected Product Candidates We focus our R&D on novel human therapeutics for the treatment of serious illness.
Our business has been and will continue to be subject to various other U.S. and foreign laws, rules and regulations, including provisions of the IRA and OB3. See Reimbursement section above. Research and Development and Selected Product Candidates We focus our R&D on novel human therapeutics for the treatment of serious illness.
Our goal is to have a world class safety record through safety leadership, engaged staff, risk management practices and integrating safety throughout our business processes.
Our goal is to have a world class safety record through safety leadership, engaged staff, risk management practices and integrating safety throughout our 25 business processes.
Our product promotions for approved product indications must comply with the statutory standards of the FDCA and the FDA’s implemented regulations and guidance. The FDA’s review of marketing and promotional activities encompasses but is not limited to direct-to-consumer advertising, healthcare-provider-directed advertising and promotion, sales representative communications to healthcare professionals, promotional programming and promotional activities involving electronic media.
Our product promotions for approved product indications must comply with the statutory standards of the FDCA and the FDA’s implemented regulations and guidance. The FDA’s review of marketing and promotional activities encompasses but is not limited to direct-to-patient advertising, healthcare-provider-directed advertising and promotion, sales representative communications to healthcare professionals, promotional programming and promotional activities involving electronic media.
See Research and Development and Selected Product Candidates section above. 23 Human Capital Resources Overview Amgen’s approach to human capital resource management starts with our mission to serve patients. We strive to serve patients by transforming the promise of science and biotechnology into therapies that have the power to restore health or save lives.
See Research and Development and Selected Product Candidates section above. 24 Human Capital Resources Overview Amgen’s approach to human capital resource management starts with our mission to serve patients. We strive to serve patients by transforming the promise of science and biotechnology into therapies that have the power to restore health or save lives.
(2) Consists of product sales of our non-principal products. 3 Prolia We market Prolia in many countries around the world. Prolia and XGEVA contain the same active ingredient but are approved for different indications, patient populations, dose and frequency of administration. Prolia was launched in the United States and Europe in 2010.
(2) Consists of product sales of our non-principal products. 4 Prolia We market Prolia in many countries around the world. Prolia and XGEVA contain the same active ingredient but are approved for different indications, patient populations, dose and frequency of administration. Prolia was launched in the United States and Europe in 2010.
For product sales outside China, Amgen also pays royalties to BeiGene. For financial information about our significant collaborative arrangements, see Part IV—Note 9, Collaborations, to the Consolidated Financial Statements. 1 We are also in a collaboration with AstraZeneca for the development of AMG 104.
For product sales outside China, Amgen also pays royalties to BeOne. For financial information about our significant collaborative arrangements, see Part IV—Note 9, Collaborations, to the Consolidated Financial Statements. 1 We are also in a collaboration with AstraZeneca for the development of AMG 104.
We monitor the financial condition of our larger customers and limit our credit exposure by setting credit limits and, in certain circumstances, by requiring letters of credit or obtaining credit insurance. 2 Our products are marketed around the world, with the United States as our largest market.
We monitor the financial condition of our larger customers and limit our credit exposure by setting credit limits and, in certain circumstances, by requiring letters of credit or obtaining credit insurance. 3 Our products are marketed around the world, with the United States as our largest market.
We believe that our Apprenticeship Program and other skills-based approaches to hiring provide us with access to a larger pool of highly motivated and productive talent while also providing underrepresented groups greater access to jobs in innovative sectors of the economy.
We believe that our Apprenticeship Program and other skills-based approaches to hiring provide us with access to a larger pool of highly motivated and productive talent while also providing greater access to jobs in innovative sectors of the economy.
The use of such measures by PBMs and insurers has continued to intensify and has thereby limited Amgen product usage and sales. Furthermore, in the United States, the top six integrated health plans and PBMs controlled about 94% of all pharmacy prescriptions.
The use of such measures by PBMs and insurers has continued to intensify and has thereby limited Amgen product usage and sales. Furthermore, in the United States, the top six integrated health plans and PBMs controlled about 89% of all pharmacy prescriptions.
Raw Materials and Medical Devices Certain raw materials, medical devices (including companion diagnostics) and components necessary for the commercial and/or clinical manufacturing of our products are provided by and are the proprietary products of unaffiliated third-party suppliers, certain of which may be our only sources for such materials.
Raw Materials and Medical Devices Certain raw materials, medical devices (including companion diagnostics) and components necessary for the commercial and/or clinical manufacturing of our products are provided by and are the proprietary products of unaffiliated third-party suppliers, certain of which may be our only source for such materials.
For example, in the EU, with limited exceptions, medical devices placed on the market must bear the Conformité Européenne marking to indicate their conformity with legal requirements. 15 Postapproval Phase After approval, we continue to monitor adverse events and product complaints reported following the use of our products through routine postmarketing surveillance and studies when applicable.
For example, in the EU, with limited exceptions, medical devices placed on the market must bear the Conformité Européenne marking to indicate their conformity with legal requirements. Post-approval Phase After approval, we continue to monitor adverse events and product complaints reported following the use of our products through routine postmarketing surveillance and studies when applicable.
Upon regulatory approval, BeiGene will assume commercialization rights in China for a specified period, and Amgen and BeiGene will share profits and losses equally until certain of these product rights revert to Amgen. Upon return of the product rights, Amgen will pay royalties to BeiGene on sales in China for a specified period.
Upon regulatory approval, BeOne will assume commercialization rights in China for a specified period, and Amgen and BeOne will share profits and losses equally until certain of these product rights revert to Amgen. Upon return of the product rights, Amgen will pay royalties to BeOne on sales in China for a specified period.
KRYSTEXXA We market KRYSTEXXA in the United States. KRYSTEXXA was acquired through our Horizon acquisition in October 2023. KRYSTEXXA is the first and only FDA-approved medicine for the treatment of chronic refractory gout. Vectibix We market Vectibix in many countries around the world.
KRYSTEXXA was acquired through our Horizon acquisition in October 2023. KRYSTEXXA is the first and only FDA-approved medicine for the treatment of chronic refractory gout. Vectibix We market Vectibix in many countries around the world.
Significant Developments Following is a summary of significant developments affecting our business that have occurred and that we have reported since the filing of our Annual Report on Form 10-K for the year ended December 31, 2023.
Significant Developments Following is a summary of significant developments affecting our business that have occurred and that we have reported since the filing of our Annual Report on Form 10-K for the year ended December 31, 2024.
To better ensure supply, Amgen has a risk mitigation strategy that uses a combination of methods, including multiple sources or backup inventory of critical raw materials. As part of our ongoing business continuity efforts, we continue to closely monitor our inventory levels and have taken additional measures to mitigate against raw material supply interruption. See Item 1A.
To better ensure supply, Amgen has a risk mitigation strategy that uses a combination of methods, including multiple sources or backup inventory of critical raw materials. As part of our ongoing business continuity efforts, we continue to closely monitor our inventory levels and have taken additional measures to mitigate against raw material supply interruption.
Bradway, age 62, has served as a director of the Company since 2011 and Chairman of the Board of Directors since 2013. Mr. Bradway has been the Company’s President since 2010 and Chief Executive Officer since 2012. From 2010 to 2012, Mr. Bradway served as the Company’s President and Chief Operating Officer. Mr.
Bradway, age 63, has served as a director of the Company since 2011 and Chairman of the Board of Directors since 2013. Mr. Bradway has been the Company’s President since 2010 and Chief Executive Officer since 2012. From 2010 to 2012, Mr. Bradway served as the Company’s President and Chief Operating Officer. Mr.
These activities are performed within the United States and its territory, including in our Puerto Rico, Rhode Island, Ohio and California facilities, as well as internationally in our Ireland, Netherlands and Singapore facilities. In addition, we use third-party contract manufacturers to supplement the capacity or capability of our commercial manufacturing network.
These activities are performed within the United States, including in the U.S. territory of Puerto Rico, Rhode Island, Ohio and California facilities, as well as internationally in our Ireland, Netherlands and Singapore facilities. In addition, we use third-party contract manufacturers to supplement the capacity or capability of our commercial manufacturing network.
Our product sales to three large wholesalers, McKesson Corporation, Cencora, Inc. and Cardinal Health, Inc., each individually accounted for more than 10% of total revenues for each of the years 2024, 2023 and 2022. On a combined basis, these wholesalers accounted for 77%, 79% and 82% of worldwide gross revenues for 2024, 2023 and 2022, respectively.
Our product sales to three large wholesalers, McKesson Corporation, Cencora, Inc. and Cardinal Health, Inc., each individually accounted for more than 10% of total revenues for each of the years 2025, 2024 and 2023. On a combined basis, these wholesalers accounted for 77%, 77% and 79% of worldwide gross revenues for 2025, 2024 and 2023, respectively.
For example, in 2022, the IRA was enacted and includes provisions requiring that beginning in 2026, mandatory price setting be introduced in Medicare for certain drugs paid for under Parts B and D, whereby manufacturers must accept a price established by the government or face penalties on all U.S. sales (starting with 10 drugs in 2026, adding 15 in 2027 and 2028, and adding 20 in 2029 and subsequent years such that by 2031 approximately 100 drugs could be subject to such set prices).
For example, in 2022, the IRA was enacted and includes provisions requiring that beginning in 2026, mandatory price setting be introduced in Medicare for certain drugs paid for under Parts B and D, whereby manufacturers must accept a price established by the government or face penalties on all U.S. sales (starting with 10 drugs effective January 1, 2026, adding 15 in 2027 and 2028, and adding 20 in 2029 and subsequent years such that by 2031 approximately 100 drugs would be subject to such set prices).
(These website addresses are not intended to function as hyperlinks, and the information contained in our website and in the SEC’s website is not intended to be a part of this filing.) 27
(These website addresses are not intended to function as hyperlinks, and the information contained in our website and in the SEC’s website is not intended to be a part of this filing.) 28
In the Asia Pacific region, we also sell our products in partnership with other companies, including Astellas Pharma Inc., BeiGene, Daiichi Sankyo Co., Ltd., Takeda Pharmaceutical Co., Ltd., Kyowa Kirin and Mitsubishi Tanabe Pharma Corporation. This international footprint allows us to deliver our medicines to more patients globally. See Business Relationships for our significant alliances.
In the Asia Pacific region, we also sell our products in partnership with other companies, including Astellas Pharma Inc., BeOne, Mitsubishi Tanabe Pharma Corporation, Takeda Pharmaceutical Co., Ltd. and Kyowa Kirin. This international footprint allows us to deliver our medicines to more patients globally. See Business Relationships for our significant alliances.
Global development costs and commercialization profits and losses related to the collaboration are shared equally. Amgen manufactures and supplies EVENITY worldwide. BeiGene, Ltd. In January 2020, we acquired an equity stake in BeiGene for approximately $2.8 billion in cash as part of a collaboration to expand our oncology presence in China.
Global development costs and commercialization profits and losses related to the collaboration are shared equally. Amgen manufactures and supplies EVENITY worldwide. BeOne Medicines Ltd. In January 2020, we acquired an equity stake in BeOne for approximately $2.8 billion in cash as part of a collaboration agreement to expand our oncology presence in China.
Reese, age 62, became the Company’s inaugural Executive Vice President and Chief Technology Officer in December 2023, responsible for accelerating the use of technology and artificial intelligence across the organization. From 2018 to December 2023, Dr. Reese served as Executive Vice President, Research and Development. Dr.
Reese, age 63, became the Company’s inaugural Executive Vice President and Chief Technology Officer in 2023, responsible for accelerating the use of technology and artificial intelligence across the organization. From 2018 to 2023, Dr. Reese served as Executive Vice President, Research and Development. Dr.
Culture We believe that an inclusive culture helps attract and retain a strong and engaged workforce informed by the varied backgrounds and experiences represented, which fosters innovation, collaboration and productivity as we execute on our mission to serve patients.
Culture We believe that our culture helps attract and retain a strong and engaged workforce informed by the varied experiences represented, which fosters innovation, collaboration and productivity as we execute on our mission to serve patients.
Patents for products already approved for one or more indications in the United States or the EU but that are currently undergoing phase 3 clinical trials for additional indications have been previously described. See Marketing, Distribution and Selected Marketed Products—Patents. Molecule Territory General subject matter Estimated expiration (1) Bemarituzumab U.S. Polypeptides 2029 Europe Polypeptides 2029 Dazodalibep U.S.
Patents for products already approved for one or more indications in the United States or the EU but that are currently undergoing Phase 3 clinical trials for additional indications have been previously described. See Marketing, Distribution and Selected Marketed Products— Patents . Molecule Territory General subject matter Estimated expiration (1) Dazodalibep U.S. Polypeptides 2034 Europe Polypeptides 2032 MariTide U.S.
We currently attempt to manage the risk associated with such suppliers by means of inventory management, relationship management and evaluation of alternative sources when feasible. We also monitor the financial condition and manufacturing quality and compliance of key suppliers and their ability to supply our needs. See Item 1A.
We work to manage the risk associated with such sole suppliers by means of inventory management, relationship management and evaluation of alternative sources when feasible. We also monitor the financial condition and manufacturing quality and compliance of key suppliers and their ability to supply our needs. See Item 1A.
Prior to joining the Company, Mr. Santos served as Site General Manager of Johnson & Johnson’s (J&J) Cordis operation in Puerto Rico. Prior to J&J, Mr. Santos held several management positions in GE’s industrial and transportation businesses.
Santos served as Site General Manager of Johnson & Johnson’s (J&J) Cordis operation in Puerto Rico. Prior to J&J, Mr. Santos held several management positions in GE’s industrial and transportation businesses.
Other Marketed Products We also market a number of other products in various markets worldwide, including but not limited to AMJEVITA/AMGEVITA, MVASI, Neulasta, RAVICTI, UPLIZNA, Parsabiv, LUMAKRAS/LUMYKRAS, Aimovig, TAVNEOS, PROCYSBI, EPOGEN and IMDELLTRA. Patents The following table lists our outstanding material patents for the indicated product by territory, general subject matter and latest expiry date.
Other Marketed Products We also market a number of other products in various markets worldwide, including but not limited to MVASI, PAVBLU, UPLIZNA, IMDELLTRA/IMDYLLTRA, AMJEVITA/AMGEVITA, TAVNEOS, Neulasta, LUMAKRAS/LUMYKRAS, RAVICTI, Parsabiv, Aimovig, WEZLANA/WEZENLA and PROCYSBI. 6 Patents The following table lists our outstanding material patents for the indicated product by territory, general subject matter and latest expiry date.
See Item 1A. Risk Factors— Our sales depend on coverage and reimbursement from government and commercial third-party payers, and pricing and reimbursement pressures have affected, and are likely to continue to affect, our profitability and Item 1A.
Risk Factors— Our sales depend on coverage and reimbursement from government and commercial third-party payers, and pricing and reimbursement pressures have affected, and are likely to continue to affect, our profitability .
In the EU, Regulation (EC) No 141/2000, as implemented by Regulation (EC) No. 847/2000, provides that a medicine can be designated as an orphan medicinal product by the EC if its sponsor can establish that: (i) the product is intended for the diagnosis, prevention or treatment of life-threatening or chronically debilitating conditions; (ii) either (a) such conditions affect not more than 5 in 10,000 persons in the EU when the application is made, or (b) the product without the benefits derived from orphan status, would not generate sufficient return in the EU to justify the necessary investment in developing the medicinal product; and (iii) there exists no satisfactory authorized method of diagnosis, prevention, or treatment of the condition that has been authorized in the EU, or even if such method exists, the product will be of significant benefit to those affected by that condition.
Risk Factors— We currently face competition from biosimilars and generics and expect to face increasing competition from biosimilars and generics in the future . 16 In the EU, Regulation (EC) No 141/2000, as implemented by Regulation (EC) No. 847/2000, provides that a medicine can be designated as an orphan medicinal product by the EC if its sponsor can establish that: (i) the product is intended for the diagnosis, prevention or treatment of life-threatening or chronically debilitating conditions; (ii) either (a) such conditions affect not more than 5 in 10,000 persons in the EU when the application is made, or (b) the product without the benefits derived from orphan status, would not generate sufficient return in the EU to justify the necessary investment in developing the medicinal product; and (iii) there exists no satisfactory authorized method of diagnosis, prevention, or treatment of the condition that has been authorized in the EU, or even if such method exists, the product will be of significant benefit to those affected by that condition.
We currently have orphan medicinal product designation for BLINCYTO in the EU and intend to seek medicinal product designation for a number of our products in the future.
We currently have orphan medicinal product designation for BLINCYTO in the EU and may seek medicinal product designation for a number of our products in the future.
Further, in 2024, the EU Artificial Intelligence (AI) Act, formally known as Regulation (EU) 2024/1689, was passed into law. Certain provisions of this regulation, such as transparency obligations and governance structures, will take effect in February and August 2025, with the regulation becoming fully effective on August 2, 2026.
Further, in 2024, the EU Artificial Intelligence (AI) Act, formally known as Regulation (EU) 2024/1689, was passed into law. Certain provisions of this regulation, such as transparency obligations and governance structures, became effective in February and August 2025, and the regulation will become fully effective on August 2, 2026.
In the United States, it is used in the indication for the treatment of osteoporosis in postmenopausal women at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy.
EVENITY was launched in the United States and Japan in 2019. In the United States, it is used in the indication for the treatment of osteoporosis in postmenopausal women at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy.
Furthermore, such state-of-the-art plants incorporate multiple innovative technologies, automation solutions and environmental sustainability into a single facility, thus requiring smaller manufacturing footprints and offering greater environmental benefits, including reduced consumption of water and energy and lower levels of carbon emissions.
Furthermore, such state-of-the-art facilities incorporate multiple innovative technologies, automation solutions and environmental sustainability, thus requiring smaller manufacturing footprints and offering greater environmental benefits, including reduced consumption of water and energy and lower levels of carbon emissions.
It is being investigated for the treatment of Sjögren’s disease. 22 Business Relationships From time to time, we enter into business relationships, including joint ventures and collaborative arrangements, for the R&D, manufacture and/or commercialization of products and/or product candidates.
It is being investigated for the treatment of TED. 23 Business Relationships From time to time, we enter into business relationships, including joint ventures and collaborative arrangements, for the R&D, manufacture and/or commercialization of products and/or product candidates.
We do this by: • investing billions of dollars annually in R&D; • pricing our medicines to reflect the value they provide; • developing more affordable therapeutic choices in the form of high-quality and reliably supplied biosimilars; • partnering with payers to share risk and accountability for health outcomes; • providing patient support and education programs; • helping patients in financial need access our medicines; and • working with policy makers, patients and other stakeholders to establish a sustainable healthcare system with access to affordable care and in which patients and their healthcare professionals are the primary decision makers.
We do this by: • investing billions of dollars annually in R&D; 12 • pricing our medicines to reflect the value they provide; • developing more affordable therapeutic choices in the form of high-quality and reliably supplied biosimilars; • partnering with payers to share risk and accountability for health outcomes; • providing patient support and education programs; • expanding patient access to our medicines, including through direct-to-patient channels; • continuing to deliver a reliable supply of medicines through our additional investments in U.S. manufacturing; • helping patients in financial need access our medicines; and • working with policy makers, patients and other stakeholders to establish a sustainable healthcare system with access to affordable care and in which patients and their healthcare professionals are the primary decision makers.
(3) A subsidiary of Johnson & Johnson. 9 (4) A subsidiary of Bristol-Myers Squibb Company. (5) REVLIMID also includes generics. (6) A subsidiary of Takeda Pharmaceutical Co., Ltd. (7) PROCRIT competes with Aranesp in supportive cancer care and predialysis settings. TEPEZZA and KRYSTEXXA currently do not face any direct competitors in the United States or Europe.
(2) Approved biosimilars for HUMIRA ® available. (3) A subsidiary of Bristol-Myers Squibb Company. (4) REVLIMID ® also includes generics. (5) A subsidiary of Takeda Pharmaceutical Co., Ltd. (6) PROCRIT ® competes with Aranesp in supportive cancer care and predialysis settings. TEPEZZA and KRYSTEXXA currently do not face any direct competitors in the United States, Europe or Japan.
The following chart shows our product sales by principal product, and the table below (dollar amounts in millions) shows product sales by geography for the years 2024, 2023 and 2022. 2024 2023 2022 Product Sales by Geography: U.S. $ 23,301 73 % $ 19,272 72 % $ 17,743 72 % ROW 8,725 27 % 7,638 28 % 7,058 28 % Total $ 32,026 100 % $ 26,910 100 % $ 24,801 100 % ____________ (1) TEPEZZA and KRYSTEXXA were acquired from our Horizon acquisition on October 6, 2023, and include product sales in the periods after the acquisition date.
The following chart shows our product sales by principal product, and the table below (dollar amounts in millions) shows product sales by geography for the years 2025, 2024 and 2023. 2025 2024 2023 Product Sales by Geography: U.S. $ 25,656 73 % $ 23,301 73 % $ 19,272 72 % ROW 9,492 27 % 8,725 27 % 7,638 28 % Total $ 35,148 100 % $ 32,026 100 % $ 26,910 100 % ____________ (1) TEPEZZA and KRYSTEXXA were acquired from our Horizon acquisition on October 6, 2023, and include product sales in the periods after the acquisition date.
Our Compensation and Management Development Committee oversees our labor and employment policies, programs and initiatives, including those relating to our talent strategy and culture of inclusion and belonging. 25 Information about Our Executive Officers The executive officers of the Company as of February 14, 2025, are set forth below. Mr. Robert A.
Our Compensation and Management Development Committee oversees our labor and employment policies, programs and initiatives, including those relating to our talent strategy and culture. 26 Information about Our Executive Officers The executive officers of the Company as of February 13, 2026, are set forth below. Mr. Robert A.
Polypeptides 2034 Europe Polypeptides 2032 Olpasiran U.S. Compounds 2036 Europe Compounds 2036 Rocatinlimab U.S. Polypeptides 2028 Europe Polypeptides 2026 Xaluritamig U.S. Polypeptides 2039 (1) Patent expiration estimates are based on issued patents, which may be challenged, invalidated or circumvented by competitors.
Antibody-peptide conjugates 2038 Europe Antibody-peptide conjugates 2038 Olpasiran U.S. Compounds 2036 Europe Compounds 2036 Rocatinlimab (2) U.S. Polypeptides 2028 Europe Polypeptides 2026 Xaluritamig U.S. Polypeptides 2039 (1) Patent expiration estimates are based on issued patents, which may be challenged, invalidated or circumvented by competitors.
Otezla We market Otezla, a small molecule that inhibits phosphodiesterase 4 (PDE4), in many countries around the world. Otezla was acquired from Bristol-Myers Squibb Company in November 2019 after its acquisition of Celgene Corporation.
See Significant Developments for additional information regarding regulatory developments. Otezla We market Otezla, a small molecule that inhibits phosphodiesterase 4 (PDE4), in many countries around the world. Otezla was acquired from Bristol Myers Squibb Company in November 2019 after its acquisition of Celgene Corporation.
Phase 2 Clinical trials investigate side-effect profiles and efficacy of product candidates in a larger patient population than phase 1, but still relatively small, who have the disease or condition under study. Phase 1 Clinical trials investigate the safety and proper dose ranges of product candidates usually in a small number of human subjects.
Phase 2 Clinical trials investigate side-effect profiles and efficacy of product candidates in a larger patient population than Phase 1, but still relatively small, who have the disease or condition under study.
Amgen manufactures and supplies the collaboration products to BeiGene. In addition, we jointly develop a portion of our oncology portfolio with BeiGene, which shares in global R&D costs by providing cash and development services of up to $1.25 billion.
In addition, we jointly develop a portion of our oncology portfolio with BeOne, which shares in global R&D costs by providing cash and development services of up to $1.25 billion.
BLINCYTO BLINCYTO is an anti-CD19 x anti-CD3 BiTE ® molecule. It is being investigated for the treatment of newly diagnosed adults with B-ALL. Daxdilimab Daxdilimab is a fully human monoclonal antibody against ILT7 that depletes certain dendritic cells.
It is being investigated for the treatment of both refractory rheumatoid arthritis and systemic lupus erythematosus with and without nephritis. BLINCYTO BLINCYTO is an anti-CD19 x anti-CD3 BiTE ® molecule. It is being investigated for the treatment of newly diagnosed adults with B-ALL. Daxdilimab Daxdilimab is a fully human monoclonal antibody against ILT7 that depletes certain dendritic cells.
BLINCYTO was launched in 2014 and has proven efficacy in a wide range of patients with CD19-positive B-ALL, including those who are MRD(–) or MRD(+) in frontline consolidation, and those with relapsed or refractory (R/R) disease. Acute lymphoblastic leukemia (ALL) is a cancer of the blood in which a particular kind of white blood cell is growing out of control.
BLINCYTO was launched in 2014 and has proven efficacy in a wide range of patients with CD19-positive B-cell acute lymphoblastic leukemia (B-ALL), including those who are MRD(–) or MRD(+) in frontline consolidation, and those with relapsed or refractory (R/R) disease.
Once multiple biosimilar versions of one of our originator products have launched, competition intensifies rapidly, resulting in accelerated net price declines for both the reference and the biosimilar products. See also Government Regulation—Regulation in the United States—Approval of Biosimilars.
Once multiple biosimilar versions of one of our originator products have launched, competition intensifies rapidly, resulting in accelerated net price declines for both the reference and the biosimilar products.
Consumer privacy laws were also passed in other states, including Iowa, Delaware, New Hampshire, Nebraska, New Jersey, Tennessee, Minnesota, Maryland, Indiana, Kentucky and Rhode Island and will be effective beginning in 2025 through 2026.
Consumer privacy laws were also passed in other states, including Iowa, Delaware, New Hampshire, Nebraska, New Jersey, Tennessee, Minnesota, Maryland, Indiana, Kentucky and Rhode Island, and became effective or are scheduled to become effective in 2025 through 2026.
ABP 206 ABP 206, a biosimilar candidate to OPDIVO, is a monoclonal antibody that binds to the receptor protein called programmed death protein 1 (PD-1). ABP 234 ABP 234, a biosimilar candidate to KEYTRUDA, is a monoclonal antibody that binds to the receptor protein (PD-1). It is being investigated in a phase 3 study for biosimilarity to KEYTRUDA.
It is being investigated for the treatment of prostate cancer. ABP 206 ABP 206, a biosimilar candidate to OPDIVO ® , is a monoclonal antibody that binds to the receptor protein called programmed death protein 1 (PD-1). ABP 234 ABP 234, a biosimilar candidate to KEYTRUDA ® , is a monoclonal antibody that binds to the receptor protein PD-1.
In our effort to attract and retain the best talent, we seek out and support talent across the globe. As part of our multidimensional hiring and talent development strategy, our Apprenticeship Program launched in 2023 in our Manufacturing and ATMOS functions and expanded to include another cohort of apprentices at our North Carolina site in January 2025.
As part of our multidimensional hiring and talent development strategy, our Apprenticeship Program launched in 2023 in our Manufacturing and ATMOS functions and expanded to include another cohort of apprentices at our North Carolina site in January 2025.
Risk Factors for a discussion of the factors that could adversely impact our manufacturing operations and the global supply of our products. Distribution We operate distribution centers in Puerto Rico, Kentucky, California and the Netherlands for worldwide distribution of the majority of our commercial and clinical products. We also use third-party distributors to supplement distribution of our products worldwide.
Risk Factors for a discussion of the factors that could adversely impact our manufacturing expansion operations and the global supply of our products. 13 Distribution We operate distribution centers in the U.S. territory of Puerto Rico, Kentucky, California and the Netherlands for worldwide distribution of the majority of our commercial and clinical products.
Esteban Santos, age 57, became Executive Vice President, Operations, in 2016. Mr. Santos joined the Company in 2007 as Executive Director, Manufacturing Technologies. From 2013 to 2016, Mr. Santos was Senior Vice President, Manufacturing. From 2008 to 2013, Mr. Santos held a number of Vice President roles at the Company in engineering, manufacturing, site operations and drug product.
Esteban Santos, age 58, became Executive Vice President, Operations, in 2016. Mr. Santos joined the Company in 2007 and has held a number of leadership roles at the Company in engineering, manufacturing, site operations and drug product, including Senior Vice President, Manufacturing, from 2013 to 2016. Prior to joining the Company, Mr.
Grygiel held several management positions at Mylan Pharmaceuticals, Inc. Ms. Rachna Khosla, age 52, became Senior Vice President, Business Development, in 2021. Ms. Khosla joined the Company in 2013 as Corporate Development Director. From 2018 to 2021, Ms. Khosla was Vice President, Business Development, and from 2016 to 2018, was Executive Director, Business Development. Prior to joining the Company, Ms.
Grygiel held several management positions at Mylan Pharmaceuticals, Inc. Ms. Rachna Khosla, age 53, became Senior Vice President, Business Development, in 2021. Ms. Khosla joined the Company in 2013 and has held leadership roles in corporate development, licensing, and mergers and acquisitions, including as Vice President Business Development, from 2018 to 2021. Prior to joining the Company, Ms.
In addition, we are required to (i) provide rebates or discounts on our products that are reimbursed through certain government programs, including Medicare and Medicaid, and (ii) provide discounts to qualifying healthcare providers under the 340B Program. Further, inappropriate expanded utilization of the 340B Program has had a negative impact on the Company’s financial performance.
In addition, we are required to (i) provide rebates or discounts on our products that are reimbursed through certain government programs, including Medicare and Medicaid, and (ii) provide discounts to qualifying healthcare providers under the 340B Program.
The reference-product primary condition is NSCLC. ABP 692 ABP 692 is an investigational biosimilar to OCREVUS, which is a monoclonal antibody that binds to CD20, which is a protein found on the surface of B-cells. AMG 104 AMG 104 is a human anti-TSLP Fab.
It is being investigated in a Phase 3 study for biosimilarity to KEYTRUDA ® . The reference-product primary condition is NSCLC. ABP 692 ABP 692, a biosimilar candidate to OCREVUS ® , is a monoclonal antibody that binds to CD20, which is a protein found on the surface of B-cells. AMG 104 AMG 104 is a human anti-TSLP Fab.
It is being investigated for the treatment of both dermatomyositis and anti-synthetase inflammatory myositis and discoid lupus erythematosus. 20 Dazodalibep Dazodalibep is a fusion protein binding CD40L on T cells, blocking their interaction with CD40-expressing B cells. It is being investigated for the treatment of Sjögren’s disease. EVENITY EVENITY is a monoclonal antibody that inhibits the action of sclerostin.
It is being investigated for the treatment of both dermatomyositis and anti-synthetase inflammatory myositis and discoid lupus erythematosus. Dazodalibep Dazodalibep is a fusion protein binding CD40L on T cells, blocking their interaction with CD40-expressing B cells. It is being investigated for the treatment of Sjögren’s disease. IMDELLTRA/IMDYLLTRA IMDELLTRA/IMDYLLTRA is an anti-DLL3 x anti-CD3 BiTE ® molecule.
In Europe, Prolia is used primarily for the treatment of osteoporosis in men and postmenopausal women at increased risk of fracture. Our patents for RANKL antibodies, including sequences, for Prolia expire in February 2025 in the United States and November 2025 in select countries in Europe. See Patents table below.
In Europe, Prolia is used primarily for the treatment of osteoporosis in men and postmenopausal women at increased risk of fracture. Our patents for RANKL antibodies, including sequences, for Prolia expired in February 2025 in the United States and in November 2025 in select countries in Europe. Repatha We market Repatha, a PCSK9 inhibitor, in many countries around the world.
(The website address is not intended to function as a hyperlink, and the information contained on our website is not intended to be a part of this filing.) The information in this section does not include, among other things, other, nonregistrational clinical trials that we may conduct for purposes other than for submission to regulatory agencies for their approval of a new product indication.
The information in this section does not include, among other things, other, nonregistrational clinical trials that we may conduct for purposes other than for submission to regulatory agencies for their approval of a new product indication.
It is also approved as a single agent for patients with relapsed or refractory multiple myeloma who have received one or more previous therapies. 4 Nplate We market Nplate in many countries around the world.
It is also approved as a single agent for patients with relapsed or refractory multiple myeloma who have received one or more previous therapies. Aranesp We market Aranesp primarily in the United States and Europe.
Our patents for RANKL antibodies, including sequences, for Prolia and XGEVA expire in February 2025 in the United States and November 2025 in select countries in Europe, and we expect sales erosion driven by biosimilar competition.
For example, our patents for RANKL antibodies, including sequences, for Prolia and XGEVA expired in February 2025 in the United States and in November 2025 in select countries in Europe, and we expect accelerated sales erosion driven by increased competition, as multiple biosimilars have launched in the United States and ROW.
Risk Factors— Guidelines and recommendations published by various organizations can reduce the use of our products. 11 Manufacturing, Distribution and Raw Materials Manufacturing We believe we are a leader in the manufacture of biologics and that our manufacturing capabilities represent a competitive advantage. The products we manufacture consist of both biologics and small molecule drugs.
Manufacturing, Distribution and Raw Materials Manufacturing We believe we are a leader in the manufacture of biologics and that our manufacturing capabilities represent a competitive advantage. The products we manufacture consist of both biologics and small molecule drugs.
ENBREL We market ENBREL, a tumor necrosis factor blocker, in the United States and Canada. ENBREL was launched in 1998 and is used primarily in indications for the treatment of adult patients with moderately to severely active rheumatoid arthritis, patients with chronic moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy and patients with active psoriatic arthritis.
ENBREL was launched in 1998 and is used primarily in indications for the treatment of adult patients with moderately-to-severely active rheumatoid arthritis, patients with chronic moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy and patients with active psoriatic arthritis. EVENITY Together with our collaboration partners, we market EVENITY in many countries around the world.
In most of the Asian markets, registration timelines depend on marketing approval in the United States or the EU. In some markets in Asia, such as China, Indonesia and Thailand, regulatory timelines can be less predictable. The regulatory process may also include manufacturing/testing facility inspections, testing of drug product upon importation and other domestic requirements.
In many Asian markets, registration timelines may be influenced by prior marketing approvals in reference jurisdictions (e.g. the United States or the EU). In some markets in Asia, such as China, Indonesia and Thailand, regulatory timelines can be more variable. The regulatory process may also include manufacturing/testing facility inspections, testing of drug product upon importation and other domestic requirements.
We expect additional biosimilar competition against both our branded and biosimilar products in the future across markets. Although biosimilars compete on price, we believe many patients, providers and payers will continue to place high value on the reputation, supply reliability and safety of our products.
Although biosimilars compete on price, we believe many patients, providers and payers will continue to place high value on the reputation, supply reliability and safety of our products. As additional biosimilar competitors come to market, we will continue to leverage our global experience to distinguish against both branded and biosimilar competitors.
TEZSPIRE is a first-in-class human monoclonal antibody that works on the primary source of inflammation: the airway epithelium, which is the first point of contact for viruses, allergens, pollutants and other environmental insults.
TEZSPIRE is a first-in-class human monoclonal antibody that works on the primary source of inflammation: the airway epithelium, which is the first point of contact for viruses, allergens, pollutants and other environmental insults. See Significant Developments for additional information regarding regulatory developments. KYPROLIS We market KYPROLIS primarily in the United States and Europe.
Methods of making 8/9/2035 Europe Compound and pharmaceutical composition (1) 7/29/2030 Europe Formulation 6/27/2034 Europe Methods of making 4/3/2035 LUMAKRAS ® /LUMYKRAS™ (sotorasib) U.S. Compounds and pharmaceutical compositions 5/21/2038 U.S. Crystalline form, pharmaceutical compositions and methods of treatment 5/20/2040 U.S. Methods of treatment 9/15/2040 Europe Compounds, pharmaceutical compositions and methods of treatment 5/21/2038 Aimovig ® (erenumab-aooe) U.S.
Methods of treatment 9/15/2040 Europe Compounds, pharmaceutical compositions and methods of treatment 5/21/2038 7 Product Territory General subject matter Expiration Parsabiv ® (etelcalcetide) U.S. Compound and pharmaceutical composition 2/7/2031 U.S. Formulation 6/27/2034 U.S. Methods of making 8/9/2035 Europe Compound and pharmaceutical composition (1) 7/29/2030 Europe Formulation 6/27/2034 Europe Methods of making 4/3/2035 Aimovig ® (erenumab-aooe) U.S.

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

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Biggest changeSuch actual or perceived safety problems or concerns can lead to: • revised or restrictive labeling for our products, or the potential for restrictive labeling that has resulted, and may in the future result, in our decision not to commercialize a product candidate; • requirement of risk management or minimization activities or other regulatory agency compliance actions related to the promotion and sale of our products; • post-marketing commitments, mandated post-marketing requirements or pharmacovigilance programs for our approved products; • product recalls of our approved products; 46 • required changes to the processes used in the manufacture of our products, which could increase our manufacturing costs and affect the availability of contract manufacturers we may utilize to assist in such manufacturing; • revocation of approval for our products from the market completely, or within particular therapeutic areas or patient types; • increased timelines or delays in being approved by the FDA or other regulatory bodies; and/or • treatments or product candidates not being approved by regulatory bodies.
Biggest changeSuch actual or perceived safety problems or concerns can lead to: • revised or restrictive labeling for our products, or the potential for restrictive labeling that has resulted, and may in the future result, in our decision not to commercialize a product candidate; • requirement of risk management or minimization activities or other regulatory agency compliance actions related to the promotion and sale of our products; • post-marketing commitments, mandated post-marketing requirements or pharmacovigilance programs for our approved products; • product recalls of our approved products; • required changes to the processes used in the manufacture of our products, which could increase our manufacturing costs and affect the availability of contract manufacturers we may utilize to assist in such manufacturing; • revocation of approval for our products from the market completely, or within particular therapeutic areas or patient types; • increased timelines or delays in being approved by the FDA or other regulatory bodies; and/or • treatments or product candidates not being approved by regulatory bodies. 47 For example, after an imbalance in positively adjudicated cardiovascular serious adverse events was observed in one of the phase 3 clinical trials for EVENITY but not in another, larger phase 3 study, in April 2019 the FDA approved EVENITY for the treatment of osteoporosis in postmenopausal women at high risk for fracture, along with a post-marketing requirement.
Product candidates, including biosimilar product candidates, or new indications for existing products (collectively, product candidates) that appear promising in the early phases of development have failed to reach the market for a number of reasons, such as: • the product candidate did not demonstrate acceptable clinical trial results even though it achieved its primary endpoints and/or demonstrated positive preclinical or early clinical trial results, for reasons that could include changes in the standard of care of medicine or expectations of health authorities; • the product candidate was not effective or not more effective than currently available or potentially competitive therapies in treating a specified condition or illness; • the product candidate was not cost effective in light of existing or potentially competitive therapeutics; • the product candidate had harmful side effects in animals or humans; • the necessary regulatory bodies, such as the FDA or EMA, did not approve the product candidate for an intended use; • reimbursement for the product candidate is limited despite regulatory approval; • the product candidate was not economical for us to manufacture and commercialize; • the patient population size is smaller than anticipated; • other parties had or may have had proprietary rights relating to our product candidate, such as patent rights, and did not let us sell it on reasonable terms, or at all; • we and certain of our licensees, partners, contracted organizations or independent investigators failed to effectively conduct clinical development or clinical manufacturing activities; • the pathway to regulatory approval or reimbursement for product candidates was uncertain or not well-defined; • the biosimilar product candidate failed to demonstrate the requisite biosimilarity to the applicable reference product, or was otherwise determined by a regulatory authority to not meet applicable standards for approval; and • a companion diagnostic device that is required with the use of a product candidate is not approved by the necessary regulatory authority.
Product candidates, including biosimilar product candidates, or new indications for existing products (collectively, product candidates) that appear promising in the early phases of development have failed to reach the market for a number of reasons, such as: • the product candidate did not demonstrate acceptable clinical trial results even though it achieved its primary endpoints and/or demonstrated positive preclinical or early clinical trial results, for reasons that could include changes in the standard of care of medicine or expectations of health authorities; • the product candidate was not effective or not more effective than currently available or potentially competitive therapies in treating a specified condition or illness; • the product candidate was not cost effective in light of existing or potentially competitive therapeutics; • the product candidate had harmful side effects in animals or humans; • the necessary regulatory bodies, such as the FDA or EMA, did not approve the product candidate for an intended use; 43 • reimbursement for the product candidate is limited despite regulatory approval; • the product candidate was not economical for us to manufacture and/or commercialize; • the patient population size is smaller than anticipated; • other parties had or may have had proprietary rights relating to our product candidate, such as patent rights, and did not let us sell it on reasonable terms, or at all; • we and certain of our licensees, partners, contracted organizations or independent investigators failed to effectively conduct clinical development or clinical manufacturing activities; • the pathway to regulatory approval or reimbursement for product candidates was uncertain or not well-defined; • the biosimilar product candidate failed to demonstrate the requisite biosimilarity to the applicable reference product, or was otherwise determined by a regulatory authority to not meet applicable standards for approval; and • a companion diagnostic device that is required with the use of a product candidate is not approved by the necessary regulatory authority.
Risks Related to Economic Conditions and Operating a Global Business • Our efforts to collaborate with or acquire other companies, products, or technology, and to integrate the operations of companies or to support the products or technology we have acquired, may not be successful, and may result in unanticipated costs, delays or failures to realize the benefits of the transactions. • A breakdown of our information technology systems, cyberattack or information security breach could significantly compromise the confidentiality, integrity and availability of our information technology systems, network-connected control systems and/or our data, interrupt the operation of our business and/or affect our reputation. • Our sales and operations are subject to the risks of doing business internationally, including in emerging markets. • We may not be able to access the capital and credit markets on terms that are favorable to us, or at all.
Risks Related to Economic Conditions and Operating a Global Business • Our efforts to collaborate with or acquire other companies, products, or technology, and to integrate the operations of companies or to support the products or technology we have acquired, may not be successful, and may result in unanticipated costs, delays or failures to realize the benefits of the transactions. • A breakdown of our information technology systems, cyberattack or information security breach could significantly compromise the confidentiality, integrity and availability of our information technology systems, network-connected control systems and/or our data, interrupt the operation of our business and/or affect our reputation. • Our sales and operations are subject to the risks of doing business internationally, including in new or emerging markets. • We may not be able to access the capital and credit markets on terms that are favorable to us, or at all.
If we fail to adequately manage the design, execution and diverse regulatory aspects of our clinical trials or to manage the production or distribution of our clinical supply, or such sites experience disruptions as a result of a natural/man-made disaster, health emergency or geopolitical conflict, corresponding regulatory approvals may be delayed or we may fail to gain approval for our product candidates or could lose our ability to market existing products in certain therapeutic areas or altogether.
If we fail to adequately manage the design, execution and diverse regulatory aspects of our clinical trials or to manage the production or distribution of our clinical supply, or such sites experience disruptions as a result of a natural/man-made disaster, health emergency or geopolitical conflict, corresponding 44 regulatory approvals may be delayed or we may fail to gain approval for our product candidates or could lose our ability to market existing products in certain therapeutic areas or altogether.
If regulatory authorities determine that we or our third-party contract manufacturers or certain of our third-party service providers have violated regulations, they may mandate corrective actions and/or issue warning letters, or even restrict, suspend or revoke our prior approvals, prohibiting us from manufacturing our products or conducting clinical trials or selling our marketed products until we or the affected third-party contract manufacturers or third-party service providers comply, or indefinitely.
If regulatory authorities determine that we or our third-party contract manufacturers or certain of our third-party service providers have violated regulations, they may mandate corrective actions and/or issue warning letters, or even restrict, suspend or revoke our prior approvals, prohibiting us from manufacturing our products or conducting clinical trials or selling our marketed products, either until we or the affected third-party contract manufacturers or third-party service providers comply, or indefinitely.
In addition, if one of our significant wholesale distributors becomes insolvent or otherwise unable to 42 continue its commercial relationship with us in its present form, it could significantly disrupt our business and adversely affect our product sales, our business and results of operations unless suitable alternatives are timely found or lost sales are absorbed by another distributor.
In addition, if one of our significant wholesale distributors becomes insolvent or otherwise unable to continue its commercial relationship with us in its present form, it could significantly disrupt our business and adversely affect our product sales, our business and results of operations unless suitable alternatives are timely found or lost sales are absorbed by another distributor.
See We perform a substantial majority of our commercial manufacturing activities at our facility in the U.S. territory of Puerto Rico and a substantial majority of our clinical manufacturing activities at our facility in Thousand Oaks, California; significant disruptions or production failures at these facilities could significantly impair our ability to supply 52 our products or continue our clinical trials and Manufacturing difficulties, disruptions or delays could limit supply of our products and limit our product sales.
See We perform a substantial majority of our commercial manufacturing activities at our facility in the U.S. territory of Puerto Rico and a substantial majority of our clinical manufacturing activities at our facility in Thousand Oaks, California; significant disruptions or production failures at these facilities could significantly impair our ability to supply our products or continue our clinical trials and Manufacturing difficulties, disruptions or delays could limit supply of our products and limit our product sales.
In April 2024, the EU also revised its Cybersecurity Directive NIS2 rules that create new cybersecurity risk management and reporting obligations. 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.
In 2024, the EU also revised its Cybersecurity Directive NIS2 rules that create new cybersecurity risk management and reporting obligations. 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.
As a result, such quality or supply problems could adversely affect our ability to timely file for, gain or maintain regulatory approvals worldwide. 44 Clinical trials must generally be designed based on the current standard of medical care. However, in certain diseases, such as cancer, the standard of care is evolving rapidly.
As a result, such quality or supply problems could adversely affect our ability to timely file for, gain or maintain regulatory approvals worldwide. Clinical trials must generally be designed based on the current standard of medical care. However, in certain diseases, such as cancer, the standard of care is evolving rapidly.
The imposition of additional requirements or our inability to meet them in a timely fashion, or at all, has delayed, and may in the future delay, our clinical development and regulatory filing efforts, delay or prevent us from obtaining regulatory approval for new product candidates or new indications for existing products, or prevent us from maintaining our current product labels.
The imposition of additional requirements or our inability to meet them in a timely fashion, or at all, has delayed, and may in the future delay, our clinical development and 46 regulatory filing efforts, delay or prevent us from obtaining regulatory approval for new product candidates or new indications for existing products, or prevent us from maintaining our current product labels.
Failure to successfully develop, modify, or supply the devices, delays in or failures of the Amgen or third-party studies, or failure by us or the third-party companies to obtain or maintain regulatory approval or clearance of the devices could result in increased 47 development costs; delays in, or failure to obtain or maintain, regulatory approval; and/or associated delays in a product candidate reaching the market or in the addition of new indications for existing products.
Failure to successfully develop, modify, or supply the devices, delays in or failures of the Amgen or third-party studies, or failure by us or the third-party companies to obtain or maintain regulatory approval or clearance of the devices could result in increased development costs; delays in, or failure to obtain or maintain, regulatory approval; and/or associated delays in a product candidate reaching the market or in the addition of new indications for existing products.
These include the IRA law that enables the U.S. government to set prices for certain drugs in Medicare, redesigns Medicare Part D benefits to shift a greater proportion of the costs to manufacturers and health plans, and enables the U.S. government to impose penalties if drug prices are increased at a rate faster than inflation (IRA Inflation Penalties).
These include the IRA that enables the U.S. government to set prices for certain drugs in Medicare, redesigns Medicare Part D benefits to shift a greater proportion of the costs to manufacturers and health plans, and enables the U.S. government to impose penalties if drug prices are increased at a rate faster than inflation (IRA Inflation Penalties).
We seek innovation through significant investment in both internal R&D and external transactions, including collaborations, partnerships, alliances, licenses, joint ventures, mergers and acquisitions (collectively, acquisition activity). 34 Acquisition activities may be subject to regulatory approvals or other requirements that are not within our control.
We seek innovation through significant investment in both internal R&D and external transactions, including collaborations, partnerships, alliances, licenses, joint ventures, mergers and acquisitions (collectively, acquisition activity). Acquisition activities may be subject to regulatory approvals or other requirements that are not within our control.
In addition, we may have difficulty finding a sufficient number of clinical trial sites and/or patients to participate in our clinical trials, 43 particularly if competitors are conducting clinical trials in similar patient populations and/or in rare disease therapy clinical trials due to the inherently small patient population potentially served by such therapies.
In addition, we may have difficulty finding a sufficient number of clinical trial sites and/or patients to participate in our clinical trials, particularly if competitors are conducting clinical trials in similar patient populations and/or in rare disease therapy clinical trials due to the inherently small patient population potentially served by such therapies.
In addition, some of our products or product candidates, including many of our oncology product candidates and products, including LUMAKRAS/LUMYKRAS and bemarituzumab, may also require the use of a companion or other diagnostic device such as a device that determines whether the patient is eligible to use our drug or that helps ensure its safe and effective use.
In addition, some of our products or product candidates, including many of our oncology product candidates and products, including LUMAKRAS/LUMYKRAS, may also require the use of a companion or other diagnostic device such as a device that determines whether the patient is eligible to use our drug or that helps ensure its safe and effective use.
If we are unable to compete effectively, this could reduce our sales, which could have a material adverse effect on our business and results of operations. Our intellectual property positions may be challenged, invalidated or circumvented, or we may fail to prevail in current and future intellectual property litigation.
If we are unable to compete effectively, this could reduce our sales, which could have a material adverse effect on our business and results of operations. 40 Our intellectual property positions may be challenged, invalidated or circumvented, or we may fail to prevail in current and future intellectual property litigation.
A number of states have adopted, and many other states are considering, PDABs, drug importation programs, reference pricing schemes, and other drug pricing actions, including proposals designed to require biopharmaceutical manufacturers to report to the state proprietary pricing information or provide advance notice of certain price increases.
A number of states have adopted, and many other states are considering, PDABs, drug importation programs, reference pricing schemes and 31 other drug pricing actions, including proposals designed to require biopharmaceutical manufacturers to report to the state proprietary pricing information or provide advance notice of certain price increases.
While we are unable to predict the precise effects of biosimilars and generics on our products, we are currently facing and expect to face greater competition in the United States, Europe and elsewhere as a result of biosimilar and generic competition and, in turn, downward pressure on our product prices and sales.
While we are unable to predict the precise effects and timing of biosimilars and generics on our products, we are currently facing and expect to face greater competition in the United States, Europe and elsewhere as a result of biosimilar and generic competition and, in turn, downward pressure on our product prices and sales.
If we are at any time unable to provide an uninterrupted supply of our products to patients, we may lose patients and physicians may elect to prescribe competing 50 therapeutics instead of our products, which could have a material adverse effect on our product sales, business and results of operations.
If we are at any time unable to provide an uninterrupted supply of our products to patients, we may lose patients and physicians may elect to prescribe competing therapeutics instead of our products, which could have a material adverse effect on our product sales, business and results of operations.
Although we monitor our distributors’, customers’ and suppliers’ financial condition and their liquidity to mitigate our business risks, some of our distributors, customers and suppliers may become insolvent, which could have a material adverse effect on our product sales, business and results of operations.
Although we monitor our distributors’, customers’ and suppliers’ financial condition and their liquidity to mitigate our business risks, some of our distributors, customers and suppliers may become insolvent, which could have a material adverse effect on 53 our product sales, business and results of operations.
Risks Related to Research and Development • We may not be able to develop commercial products despite significant investments in R&D. • We must conduct clinical trials in humans before we commercialize and sell any of our product candidates or existing products for new indications. • Our current products and products in development cannot be sold without regulatory approval. • Some of our products are used with drug delivery or companion diagnostic devices that have their own regulatory, manufacturing and other risks. 28 • Some of our pharmaceutical pipeline and our commercial product sales rely on collaborations with third parties, which may adversely affect the development and sales of our products.
Risks Related to Research and Development • We may not be able to develop commercial products despite significant investments in R&D. • We must conduct clinical trials in humans before we commercialize and sell any of our product candidates or existing products for new indications. • Our current products and products in development cannot be sold without regulatory approval. 29 • Some of our products are used with drug delivery or companion diagnostic devices that have their own regulatory, manufacturing and other risks. • Some of our pharmaceutical pipeline and our commercial product sales rely on collaborations with third parties, which may adversely affect the development and sales of our products.
Value assessments may come from private organizations that publish their findings and offer recommendations relating to the products’ reimbursement by government and private payers. Some companies and payers have announced pricing and payment decisions based in part on the assessments of private organizations.
Value assessments may come from private organizations that publish their findings and offer recommendations relating to the products’ reimbursement by government and 33 private payers. Some companies and payers have announced pricing and payment decisions based in part on the assessments of private organizations.
We continuously monitor complaints and adverse events and implement additional enhancements as needed. Loss of regulatory approval or clearance of a device that is used with our product may also result in the removal of our product from the market.
We continuously monitor complaints and adverse events and implement additional enhancements as needed. Loss of regulatory approval or clearance of a device that is used with our product may also result in 48 the removal of our product from the market.
While we have achieved most of our goals set in prior years, whether we can achieve our current and future ESG goals continues to be uncertain and remains subject to numerous risks, including evolving regulatory requirements and social expectations affecting ESG practices, our ability to recruit, develop and retain a diverse workforce, the availability of suppliers and collaboration partners that can meet our environmental goals, the effects of the organic growth of our business and potential acquisitions of other businesses on our ESG performance, and the availability and cost of technologies or resources, such as carbon credits, that support our goals.
While we have achieved most of our goals set in prior years, whether we can achieve our current and future sustainability goals continues to be uncertain and remains subject to numerous risks, including evolving regulatory requirements and social expectations affecting sustainability practices, our ability to recruit, develop and retain a diverse workforce, the availability of suppliers and collaboration partners that can meet our environmental goals, the effects of the organic growth of our business and potential acquisitions of other businesses on our sustainability performance, and the availability and cost of technologies or resources, such as carbon credits, that support our goals.
Ultimately, additional discounts, rebates, fees, coverage changes, plan changes, restrictions or exclusions imposed by these commercial payers could have a material adverse 31 effect on our product sales, business and results of operations.
Ultimately, additional discounts, rebates, fees, coverage changes, plan changes, restrictions or exclusions imposed by these commercial payers could have a material adverse effect on our product sales, business and results of operations.
Additionally, any negative results from such trials could materially affect the extent of approvals, the use, reimbursement and sales of our products, our business and results of operations. Our current products and products in development cannot be sold without regulatory approval.
Additionally, any negative results from such trials could materially affect the extent of approvals, the use, reimbursement and sales of our products, our business and results of operations. 45 Our current products and products in development cannot be sold without regulatory approval.
Further, inappropriate expanded utilization of the 340B Program from broadened application of the 340B discounts has had, and is 30 expected to continue to have, a negative impact on the Company’s product sales, business and results of operations.
Further, inappropriate expanded utilization of the 340B Program from broadened application of the 340B discounts has had, and is expected to continue to have, a negative impact on the Company’s product sales, business and results of operations.
Also, certain of the raw materials required in the commercial and clinical manufacturing of our products are sourced from other countries and/or derived from biological sources, including mammalian tissues, bovine serum and human serum albumin.
Also, certain of the raw 49 materials required in the commercial and clinical manufacturing of our products are sourced from other countries and/or derived from biological sources, including mammalian tissues, bovine serum and human serum albumin.
Even though we continue to invest in the monitoring, protection and resilience of our critical and/or sensitive data and systems, there can be no assurances that our efforts will detect, prevent or fully recover systems or data from all breakdowns, service interruptions, attacks and/or breaches of our systems that could adversely affect our business and operations and/or result in the loss or exposure of critical, proprietary, private, confidential or otherwise sensitive data, which could result in material financial, legal business or reputational harm to us or negatively affect our stock price.
Even though we continue to invest in the monitoring, protection and resilience of our critical and/or sensitive data and systems, there can be no assurance that our efforts will detect, prevent or fully recover systems or data from all breakdowns, service interruptions, attacks and/or breaches of our systems that could adversely affect our business and operations and/or result in the loss or exposure of critical, proprietary, private, confidential or otherwise sensitive data, which could result in material financial, legal business or reputational harm to us or negatively affect our stock price.
Although this breach did not have a significant effect on our business, there can be no assurance that a similar future breach would not result in a material adverse effect on our business or results of operations.
Although that breach did not have a significant effect on our business, there can be no assurance that a similar future breach would not result in a material adverse effect on our business or results of operations.
In February 2024, Change Healthcare, a large U.S. insurance claim and co-pay card processing clearinghouse, experienced a ransomware attack that has caused significant disruptions to healthcare provider and pharmacy operations.
In 2024, Change Healthcare, a large U.S. insurance claim and co-pay card processing clearinghouse, experienced a ransomware attack that has caused significant disruptions to healthcare provider and pharmacy operations.
Regulatory authorities could also add new requirements, such as the completion of enrollment in a confirmatory study or the completion of an outcomes study or a meaningful portion of an 45 outcomes study, as conditions for obtaining approval or obtaining an indication.
Regulatory authorities could also add new requirements, such as the completion of enrollment in a confirmatory study or the completion of an outcomes study or a meaningful portion of an outcomes study, as conditions for obtaining approval or obtaining an indication.
Payers, including PBMs, have sought, and continue to seek, price discounts or rebates in connection with the placement of our products on their formularies or those they manage, and to also impose restrictions on access to, or usage of, our products (such as Step Therapy), require that patients receive the payer’s prior authorization before covering the product, and/or chosen to exclude certain indications for which our products are approved.
Payers, including PBMs, have sought, and continue to seek, price discounts or rebates in connection with the placement of our products on their formularies or those they 32 manage, and to also impose restrictions on access to, or usage of, our products (such as Step Therapy), require that patients receive the payer’s prior authorization before covering the product, and/or to exclude certain indications for which our products are approved.
See Our sales depend on 32 coverage and reimbursement from government and commercial third-party payers, and pricing and reimbursement pressures have affected, and are likely to continue to affect, our profitability.
See Our sales depend on coverage and reimbursement from government and commercial third-party payers, and pricing and reimbursement pressures have affected, and are likely to continue to affect, our profitability.
Concentration of sales at certain of our wholesaler distributors, and consolidation of private payers, such as insurers, and PBMs has negatively affected, and may continue to negatively affect, our business.
See —Concentration of sales at certain of our wholesaler distributors, and consolidation of private payers, such as insurers, and PBMs has negatively affected, and may continue to negatively affect, our business.
While we have attempted, 40 and expect to continue to attempt, to challenge the patents held by other companies, our efforts may be unsuccessful. For examples of and information related to our patent litigation, see Part IV—Note 20, Contingencies and commitments, to the Consolidated Financial Statements. Certain of the existing patents on our products have expired or will soon expire.
While we have attempted, and expect to continue to attempt, to challenge the patents held by other companies, our efforts may be unsuccessful. For 41 examples of and information related to our patent litigation, see Part IV—Note 20, Contingencies and commitments, to the Consolidated Financial Statements. Certain of the existing patents on our products have expired or will soon expire.
Significant disputes can and have arisen with tax authorities involving issues regarding the timing and amount of deductions, the use of tax credits and allocations of income and expenses among various tax jurisdictions because of differing interpretations of tax laws, regulations and relevant facts, and such tax authorities (including the IRS) are becoming more aggressive in their audits and are particularly focused on such matters.
Significant disputes can and have arisen with tax authorities involving issues regarding the timing and amount of deductions, the use of tax credits and allocations of income and expenses among various tax jurisdictions because of differing interpretations of tax laws, regulations and relevant facts, and such tax authorities (including the IRS) are becoming more aggressive in its audits and are particularly focused on such matters.
See Part II, Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations—Results of Operations, Income Taxes, and Part IV—Note 7, Income taxes, to the Consolidated Financial Statements.
See Part II, Item 7. 34 Management’s Discussion and Analysis of Financial Condition and Results of Operations—Results of Operations— Income Taxes , and Part IV—Note 7, Income taxes, to the Consolidated Financial Statements.
In addition, delays or failures to develop diagnostic tests for our clinical trials can affect the timely enrollment of such trials and lead to delays or inability to obtain marketing approval. If we were unable to market and sell our products or product candidates, our business and results of operations could be materially and adversely affected.
In addition, delays or failures to develop diagnostic tests or delivery devices for our clinical trials can affect the timely enrollment of such trials and lead to delays or inability to obtain marketing approval. If we were unable to market and sell our products or product candidates, our business and results of operations could be materially and adversely affected.
Although services have been rerouted and restored, and the impact on our business has been immaterial, similar disruptions may occur in the future stemming from the interconnectedness of the U.S. healthcare ecosystem and industry reliance on centralized claims processing systems and networks, and such future disruptions may have a material adverse effect on our business or results of operations.
Although services have been rerouted and restored, and the impact on our business was immaterial, similar disruptions may occur in the future stemming from the interconnectedness of the U.S. healthcare ecosystem and industry reliance on centralized claims processing systems and networks, and such future disruptions may have a material adverse effect on our business or results of operations.
Achieving our ESG goals requires long-term investments and broad, coordinated activity, and we may be required to incur additional costs or allocate additional resources towards monitoring, reporting and implementing our ESG programs. Further, we may fail to accurately assess our stakeholders’ ESG priorities and concerns, as such priorities and concerns have been rapidly changing.
Achieving our sustainability goals requires long-term investments and broad, coordinated activity, and we may be required to incur additional costs or allocate additional resources towards monitoring, reporting and implementing our sustainability programs. Further, we may fail to accurately assess our stakeholders’ sustainability priorities and concerns, as such priorities and concerns have been rapidly changing.
Policymakers, regulators and investors globally have increased their focus on ESG matters, resulting in rapidly evolving and diverging expectations and standards. For example, California recently enacted the Climate Corporate Data Accountability Act that requires, among other things, disclosure of greenhouse gas emissions.
Policymakers, regulators and investors globally have increased their focus on sustainability matters, resulting in rapidly evolving and diverging expectations and standards. For example, California recently enacted the Climate Corporate Data Accountability Act that requires, among other things, disclosure of greenhouse gas emissions.
Ultimately, as with U.S. federal government actions, existing or future state government actions or ballot initiatives may also have a material adverse effect on our product sales, business and results of operations. —U.S. commercial payer actions have affected, and may continue to affect, access to and sales of our products Payers, including healthcare insurers, PBMs, integrated healthcare delivery systems (vertically-integrated organizations built from consolidations of healthcare insurers and PBMs) and group purchasing organizations, are continuing to seek ways to further reduce their costs.
Ultimately, existing or future state government actions or ballot initiatives may also have a material adverse effect on our product sales, business and results of operations. —U.S. commercial payer actions have affected, and may continue to affect, access to and sales of our products Payers, including healthcare insurers, PBMs, integrated healthcare delivery systems (vertically-integrated organizations built from consolidations of healthcare insurers and PBMs) and group purchasing organizations, are continuing to seek ways to further reduce their costs.
Risks Related to Operations • We perform a substantial majority of our commercial manufacturing activities at our facility in the U.S. territory of Puerto Rico and a substantial majority of our clinical manufacturing activities at our facility in Thousand Oaks, California; significant disruptions or production failures at these facilities could significantly impair our ability to supply our products or continue our clinical trials. • We rely on third-party suppliers for certain of our raw materials, medical devices and components. • Manufacturing difficulties, disruptions or delays could limit supply of our products and limit our product sales. • Our business and operations may be negatively affected by the failure, or perceived failure, of achieving our environmental, social and governance objectives. • The effects of global climate change and related natural disasters could negatively affect our business and operations.
Risks Related to Operations • We perform a substantial majority of our commercial manufacturing activities at our facility in the U.S. territory of Puerto Rico and a substantial majority of our clinical manufacturing activities at our facility in Thousand Oaks, California; significant disruptions or production failures at these facilities could significantly impair our ability to supply our products or continue our clinical trials. • We rely on third-party suppliers for certain of our raw materials, medical devices and components. • Manufacturing difficulties, disruptions or delays could limit supply of our products and limit our product sales. • Our business and operations may be negatively affected by the failure, or perceived failure, of achieving our sustainability objectives. • The effects of global climate change and related natural disasters could negatively affect our business and operations.
In July 2024, Canada (through Environment and Climate Change Canada) issued a notice requiring reporting on PFAS manufacture, import, and use in Canada.
In 2024, Canada (through Environment and Climate Change Canada) issued a notice requiring reporting on PFAS manufacture, import, and use in Canada.
Similarly, actual or 53 perceived safety issues with our products or similar products or unexpected clinical trial results can have an immediate and rapid effect on our stock price, whether or not our operating results are materially affected. Item 1B. UNRESOLVED STAFF COMMENTS None.
Similarly, actual or perceived safety issues with our products or similar products or unexpected clinical trial results can have an immediate and rapid effect on our stock price, whether or not our operating results are materially affected. 54 Item 1B. UNRESOLVED STAFF COMMENTS None.
Remote and hybrid working arrangements, including those of many third-party providers, can increase cybersecurity risks due to the challenges associated 35 with managing remote computing assets and security vulnerabilities that are present in many non-corporate and home networks.
Remote and hybrid working arrangements, including those of many third-party providers, can increase cybersecurity risks due to the challenges associated with managing remote computing assets and security vulnerabilities that are 36 present in many non-corporate and home networks.
As we continue our expansion efforts in emerging markets around the world, through acquisitions and licensing transactions as well as through the development and introduction, both independently and through collaborations such as our collaboration with BeiGene, of our products in new markets, we face numerous risks to our business.
As we continue our expansion efforts in emerging markets around the world, through acquisitions and licensing transactions as well as through the development and introduction, both independently and through collaborations such as our collaboration with BeOne, of our products in new markets, we face numerous risks to our business.
Any failure or perceived failure to meet our ESG program priorities could result in a material adverse effect on our reputation, business and stock price. The effects of global climate change and related natural disasters could negatively affect our business and operations.
Any failure or perceived failure to meet our sustainability program priorities could result in a material adverse effect on our reputation, business and stock price. The effects of global climate change and related natural disasters could negatively affect our business and operations.
Our ESG report is made available on our website and describes our current ESG goals and the progress we have made on the ESG issues that we believe our external and internal stakeholders consider to be important, based on surveys, interviews and certain frameworks for corporate responsibility.
Our sustainability report is made available on our website and describes our current sustainability goals and the progress we have made on the sustainability issues that we believe our external and internal stakeholders consider to be important, based on surveys, interviews and certain frameworks for corporate responsibility.
In the United States, the BPCIA provided for such a pathway. Discussions within the FDA and other regulatory authorities, and between regulatory authorities and sponsors, continue as to the evidence needed to demonstrate biosimilarity or interchangeability for specific products.
In the United States, the BPCIA provides for such a pathway. Discussions within the FDA and other regulatory authorities, and between regulatory authorities and sponsors, continue as to the evidence needed to demonstrate biosimilarity or interchangeability for specific products.
The IRA’s Medicare price setting and Medicare redesign are likely to have a material adverse effect on our sales, our business and our results of operations, and such impact is expected to increase through the end of the decade and will depend on factors including the extent of our portfolio’s exposure to Medicare reimbursement, the rate of inflation over time, the number of our products selected for Medicare price setting and the timing of market entry of generic or biosimilar competition.
The IRA’s Medicare price setting and Medicare redesign have had, and are likely to have, an adverse effect on our sales, our business and our results of operations, and such impact is expected to increase through the end of the decade and will depend on factors including the extent of our portfolio’s exposure to Medicare reimbursement, the rate of inflation over time, the number of our products selected for Medicare price setting and the timing of market entry of generic or biosimilar competition.
As a result, our products have been competing and may continue to compete, and our product candidates may compete, against products or product candidates that offer higher rebates or discounts, lower prices, equivalent or superior efficacy, better safety profiles, easier administration, earlier market availability or other competitive 39 features.
As a result, our products have been competing and may continue to compete, and our product candidates may compete, against products or product candidates that offer higher rebates or discounts, lower prices, equivalent or superior efficacy, better safety profiles, easier administration, earlier market availability, established market position or other competitive features.
Additionally, regional disruptions, including natural and man-made disasters, health emergencies (such as novel viruses or pandemics, including the COVID-19 pandemic), or geopolitical conflicts (such as the ongoing armed conflicts in Ukraine and the Middle East) have significantly disrupted the timing of clinical trials, and in the future could disrupt the timing, execution and outcome of clinical trials.
Additionally, regional disruptions, including natural and man-made disasters, health emergencies (such as novel viruses or pandemics), or geopolitical conflicts (such as the ongoing armed conflicts in Ukraine and the Middle East) have significantly disrupted the timing of clinical trials, and in the future could disrupt the timing, execution and outcome of clinical trials.
Changes in laws or regulations with respect to the use and/or presence of certain chemicals in our products or the components used in the research, development, manufacture and/or packaging of our products could also disrupt or restrict our ability to develop, produce or sell our products in the affected jurisdictions. For example, the EU, the U.S. Congress, the U.S.
Changes in laws or regulations with respect to the use and/or presence of certain chemicals in our products or the components used in the research, development, manufacture and/or packaging of our products could also disrupt or restrict our ability to develop, produce or sell our products. For example, the EU, Canada, the U.S. Congress, the U.S.
While the individual was detected and terminated before any data was extracted or malware installed, there can be no assurance that future attempts by similar actors will be unsuccessful. System vulnerabilities and/or cybersecurity breaches experienced by our third-party service providers have constituted a substantial share of the information security risks that have affected us.
While these individuals were detected and terminated before any data was extracted or malware installed, there can be no assurance that future attempts by similar actors will be unsuccessful. System vulnerabilities and/or cybersecurity breaches experienced by our third-party service providers have constituted a substantial share of the information security risks that have affected us.
As the cyber-threat landscape evolves, these attacks are growing in frequency, sophistication, and intensity, and are becoming increasingly difficult to detect and increasingly sophisticated in using techniques and tools—including artificial intelligence—that circumvent security controls, evade detection and remove forensic evidence.
As the cyber-threat landscape evolves, these attacks are growing in frequency, sophistication, and intensity, and are becoming increasingly difficult to detect and increasingly sophisticated in using techniques and tools, including AI, that circumvent security controls, evade detection and remove forensic evidence.
See Part I, Item 1. Business—Reimbursement. Our business has been, and will continue to be, affected by legislative actions changing U.S. federal reimbursement policy.
See Item 1. Business—Reimbursement. Our business has been, and will continue to be, affected by legislative actions changing U.S. federal reimbursement policy.
Our expansion efforts in China and emerging markets around the world are dependent upon the establishment of an environment that is predictable, navigable and supportive of biopharmaceutical innovation, sustained access for our products and predictable pricing controls.
Our expansion efforts in China and new and emerging markets around the world are dependent upon the existence or establishment of an environment that is predictable, navigable and supportive of biopharmaceutical innovation, sustained access for our products and predictable pricing controls.
Additionally, the views of regulatory agencies relating to the requirements for accelerated approval may change over time, and trial designs that were sufficient to support accelerated approvals for some oncology products may not be considered sufficient for later candidates.
Additionally, the views of regulatory agencies relating to the requirements for accelerated approval have evolved over time, and trial designs that were sufficient to support accelerated approvals for some oncology products may not be considered sufficient for later candidates.
Regulatory agencies periodically perform inspections of our pharmacovigilance processes, including our adverse event reporting. In the United States, for our products with approved Risk Evaluation and Mitigation Strategies (REMS, see Part I, Item 1. Business—Government Regulation—Postapproval Phase), we are required to submit periodic assessment reports to the FDA to demonstrate that the goals of the REMS are being met.
Regulatory agencies periodically perform inspections of our pharmacovigilance processes, including our adverse event reporting. In the United States, for our products with approved Risk Evaluation and Mitigation Strategies (REMS, see Item 1. Business—Government Regulation— Post-approval Phase ), we are required to submit periodic assessment reports to the FDA to demonstrate that the goals of the REMS are being met.
With the proliferation of companies pursuing biopharmaceuticals, several of our biosimilar products have entered, and a number of our product candidates may enter, markets with one or more competitors or with competitors soon to arrive.
With the proliferation of companies pursuing biopharmaceuticals, several of our biosimilar products have entered, and a number of our product candidates are expected to enter, markets with one or more competitors or with competitors soon to arrive.
To achieve our business objectives, we rely on sophisticated information technology systems, including hardware, software, technology infrastructure, online sites and networks for both internal and external operations, mobile applications, cloud services and network-connected control systems, some of which are managed, hosted, provided or serviced by third parties.
To achieve our business objectives, we rely on sophisticated information technology systems, including hardware, software, technology infrastructure, online sites and networks for both internal and external operations, mobile applications, cloud services, artificial intelligence (AI)-enabled tools and systems, and network-connected control systems, some of which are managed, hosted, provided or serviced by third parties.
Among the reasons we may be unable to obtain these raw materials, medical devices and components include: • regulatory requirements or action by regulatory agencies or others; • adverse financial or other strategic developments at or affecting the supplier, including bankruptcy; • unexpected demand for or shortage of raw materials, medical devices or components; • failure to comply with our quality standards which results in quality and product failures, complaints, product contamination and/or recall; • a material shortage, contamination, recall and/or restrictions on the use of certain biologically derived substances or other raw materials; • discovery of previously unknown or undetected imperfections in raw materials, medical devices or components; • cyberattacks on supplier systems; • natural or other disasters, including hurricanes, earthquakes, volcanoes or fires; • labor disputes (such as strikes) or shortages, including from the effects of health emergencies (such as novel viruses or pandemics) or natural disasters; and • geopolitical conflicts (such as the ongoing conflicts in Ukraine and the Middle East).
Among the reasons we may be unable to obtain these raw materials, medical devices and components include: • regulatory requirements or action by regulatory agencies or others; • adverse financial or other strategic developments at, or affecting, the supplier, including bankruptcy; • unexpected demand for, or shortage of, raw materials, medical devices or components; • failure to comply with our quality standards which results in quality and product failures, complaints, product contamination and/or recall; • a material shortage, contamination, recall and/or restrictions on the use of certain biologically derived substances or other raw materials; • discovery of previously unknown or undetected imperfections in raw materials, medical devices or components; • cyberattacks on supplier systems; • natural or other disasters, including hurricanes, earthquakes, volcanoes or fires; • labor disputes (such as strikes) or shortages, including from the effects of health emergencies (such as novel viruses or pandemics) or natural disasters; • tariffs or other trade barriers that increase costs, limit availability, or disrupt the flow of goods; and • geopolitical conflicts (such as the ongoing conflicts in Ukraine and the Middle East).
Our sales and operations are subject to the risks of doing business internationally, including in emerging markets.
Our sales and operations are subject to the risks of doing business internationally, including in new or emerging markets.
There is no guarantee that our efforts and strategies to expand sales in emerging markets will succeed.
There is no guarantee that our efforts and strategies to expand sales in new or emerging markets will succeed.
The number of third-party contract manufacturers that we use has increased with our acquisition of Horizon, as Horizon required such contract manufacturers for all of its products. See Part I, Item 1.
The number of third-party contract manufacturers that we use has increased with our acquisition of Horizon, as Horizon required contract manufacturers for all of its products. See Item 1.
In the United States, the FDA has approved numerous biosimilars, including biosimilar versions of Neulasta, EPOGEN, ENBREL, Prolia and XGEVA, and a growing number of companies have announced that they are also developing biosimilar versions of our products.
Business—Government Regulation— Regulation in the United States — Approval of Biosimilars . In the United States, the FDA has approved numerous biosimilars, including biosimilar versions of Neulasta, EPOGEN, ENBREL, Prolia and XGEVA, and a growing number of companies have announced that they are also developing biosimilar versions of our products.
Further, we rely on commercial transportation, including air and sea freight, for the distribution of our products to our customers, which has been negatively affected by the COVID-19 pandemic, labor unrest, natural disasters and geopolitical security threats.
Further, we rely on commercial transportation, including air and sea freight, for the distribution of our products to our customers, which has been negatively affected by pandemics, labor unrest, natural disasters and geopolitical security threats.
If our ESG practices fail to meet our stakeholders’ expectations and standards, or if we fail to comply with ESG-related regulations across our global business, there could be a material adverse effect on our reputation, business and, ultimately, our stock price.
If our sustainability practices fail to meet stakeholders’ expectations and applicable standards, or if we fail to comply with 52 sustainability-related regulations across our global business, there could be a material adverse effect on our reputation, business and, ultimately, our stock price.
Further, following the enactment of the IRA, the environment remains dynamic and U.S. policymakers continue to demonstrate interest in health care and drug pricing changes. For example, in April 2024, CMS finalized policy changes that will give Part D plans more flexibility to substitute biosimilars for innovator products on formularies in 2025.
Further, following the enactment of the IRA, the environment remains dynamic, and U.S. policymakers continue to demonstrate interest in health care and drug pricing changes as well as potential changes affecting intellectual property. For example, in April 2024, CMS finalized policy changes that will give Part D plans more flexibility to substitute biosimilars for innovator products on formularies in 2025.
Acquisition activities are complex, time consuming and expensive and may result in unanticipated costs, delays or other operational or financial problems related to integrating the acquired company and business with our company, which may divert our management’s attention from other business issues and opportunities and restrict the full realization of the anticipated benefits of such transactions within the expected timeframe or at all.
Acquisition activities are complex, time consuming and expensive and may result in unanticipated costs, delays, or other operational or financial problems related to integrating the acquired company and business with our company, which may divert our management’s attention from other business issues and opportunities may prevent us from realizing the anticipated benefits of such transactions within the expected timeframe or at all.
These bills vary, but typically include provisions on restricting a manufacturer’s ability to direct drugs in 340B channels, recognizing 340B contract pharmacies and a prohibition on requiring the inclusion of 340B claims modifiers. In March 2024, the U.S.
These bills vary, but typically include provisions restricting a manufacturer’s ability to direct drugs in 340B channels, recognizing 340B contract pharmacies and a prohibition on requiring the inclusion of 340B claims modifiers.
Failure to successfully fully integrate the Horizon business into ours and/or achieve its anticipated strategic benefits may result in our incurring significant asset impairment or restructuring charges, and could have a material adverse effect on our business, results of operations and stock price.
Failure to successfully fully integrate acquired businesses into ours and/or achieve anticipated strategic benefits may result in our incurring significant asset impairment or restructuring charges, and could have a material adverse effect on our business, results of operations and stock price.
These and other challenges may arise in connection with our acquisitions, including our acquisitions of ChemoCentryx and Horizon and/or our collaborations with BeiGene and Kyowa Kirin, or with other acquisition activities, which could have a material adverse effect on our business, results of operations and stock price.
These and other challenges may arise in connection with our acquisitions, including our acquisitions of ChemoCentryx, Horizon and Dark Blue Therapeutics and/or our collaborations with BeOne and Kyowa Kirin, or with other acquisition activities, which could have a material adverse effect on our business, results of operations and stock price.
Further, failures or difficulties in integrating or retaining new personnel or in integrating the operations of the businesses, products or assets we acquire (including related technology, research, development and commercial operations, compliance programs, manufacturing, distribution and general business operations and procedures and ESG activities) may affect our ability to realize the benefits of the transaction and grow our business and may result in us incurring asset impairment or restructuring charges.
Further, failures or difficulties in integrating or retaining key personnel, or in integrating the operations of the businesses, products or assets we acquire (including related technology, research, development and commercial operations, compliance programs, manufacturing, distribution and general business operations and procedures and sustainability activities) may adversely affect our ability to realize the benefits of the transaction or grow our business, and may result in asset impairment or restructuring charges.
Business—Manufacturing, Distribution and Raw Materials—Manufacturing; and Part I, Item 1A, Risk Factors— Our efforts to collaborate with or acquire other companies, products, or technology, and to integrate the operations of companies or to support the products or technology we have acquired, may not be successful, and may result in unanticipated costs, delays or failures to realize the benefits of the transactions .
Business—Manufacturing, Distribution and Raw Materials— Manufacturing ; and Our efforts to collaborate with or acquire other companies, products, or technology, and to integrate the operations of companies or to support the products or technology we have acquired, may not be successful, and may result in unanticipated costs, delays or failures to realize the benefits of the transactions .
Additionally, on January 5, 2024, the FDA authorized Florida to move forward with its importation program proposal, though the state has not completed any significant steps towards importation within the one-year authorization window. Colorado, Maine, New Hampshire, New Mexico, Texas and Vermont have also enacted state importation laws, and some have submitted plans for approval to the FDA.
Additionally, in 2024, the FDA authorized Florida to move forward with its importation program proposal, though the state has not yet completed any significant steps towards importation within the two-year authorization window. Colorado, Maine, New Hampshire, New Mexico, Texas and Vermont have also enacted state importation laws, and some have submitted plans for approval to the FDA.
Although this vulnerability has not resulted in any significant adverse effects on us, there can be no assurances that a similar future vulnerability in the software and services that we use would not result in a material adverse effect on our business or results of operations.
Although these vulnerabilities did not result in any significant adverse effects on us, there can be no assurances that a similar future vulnerability in the software and services that we use would not result in a material adverse effect on our business or results of operations.
For example, Horizon adds more than 30 contract manufacturing organizations (CMOs) to our operations, many of which are single source suppliers (including the CMO that produces TEPEZZA drug substance and the CMO that produces all of our KRYSTEXXA drug substance in Israel that is affected by the current conflict in Israel and Gaza).
For example, our acquisition of Horizon resulted in the addition of more than 30 contract manufacturing organizations (CMOs) to our operations, many of which are single-source suppliers, including the CMO that produces TEPEZZA drug substance and the CMO that produces all of our KRYSTEXXA drug substance in Israel, which is affected by the current conflict in the Middle East.

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Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

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Biggest changeFurther, in support of our internal controls, our CISO also reviews cybersecurity matters and trends with our Accounting and Law functions at least on a quarterly basis. 55 Information Systems Acquired from Horizon Therapeutics plc On October 6, 2023, we completed our acquisition of Horizon. Certain Horizon legacy information systems are maintained separately from Amgen’s preexisting information system infrastructure.
Biggest changeFurther, in support of our internal controls, our CISO also reviews cybersecurity matters and trends with our Accounting and Law functions at least on a quarterly basis. In 2025, we substantially transitioned or decommissioned the technology systems from the legacy Horizon environment to the Amgen environment.
The CDT team also conducts reviews and evaluations of our cybersecurity resilience program with Amgen’s Cybersecurity & Digital Trust Governance Council (which includes leaders from CDT, Worldwide Compliance and Business Ethics, Regulatory Affairs, Operations, R&D, Global Commercial Operations, Corporate Audit, Law and Business Development functions).
The CDT team also conducts reviews and evaluations of our cybersecurity resilience program with Amgen’s Cybersecurity & Digital Trust Governance Council (which includes leaders from CDT, Worldwide Compliance and Business Ethics, Regulatory Affairs, Operations, R&D, Global Commercial Operations, Corporate Audit, Finance, Law and Business Development functions).
Our CISO is overseen by our CIO, who has 27 years of experience in information systems (including over 14 years at the Company and more than 6 years as a senior technology executive outside of Amgen), and holds a Computer Information Systems B.S. and an Information Technology Management MBA.
Our CISO is overseen by our CIO, who has 28 years of experience in information systems (including over 15 years at the Company and more than 6 years as a senior technology executive outside of Amgen), and holds a Computer Information Systems B.S. and an Information Technology Management MBA.
The AI Governance Council is co-sponsored by our Chief Compliance Officer and Senior Vice President, Artificial Intelligence & Data. 54 Despite our layered controls and cybersecurity efforts, the Company and its third-party vendors have experienced cyberattacks and information security vulnerabilities, and while such incidents have not had a material adverse effect on the Company, there can be no assurance that future cybersecurity attacks or incidents would not result in a material adverse effect on our business strategy, results of operations or financial condition.
Despite our layered controls and cybersecurity efforts, the Company and its third-party vendors have experienced cyberattacks and information security vulnerabilities, and while such incidents have not had a material adverse effect on the Company, there can be no assurance that future cybersecurity attacks or incidents would not result in a material adverse effect 55 on our business strategy, results of operations or financial condition.
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We are continuing to operationally integrate and transition the legacy Horizon systems into our own, with the integrated systems becoming subject to Amgen’s cybersecurity risk management structure and strategy.
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The AI Governance Council is co-sponsored by our Chief Compliance Officer and Senior Vice President, Artificial Intelligence & Data.
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While we are integrating these systems, our CISO and CDT function are engaging in cybersecurity risk management activities, and any cybersecurity incidents detected on the legacy Horizon information systems are assessed, mitigated and remediated by our CDT function’s Operations, Incident Response and Cyber Threat Intelligence teams and reported in accordance with the governance processes detailed above. See Item 1A.
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The remaining systems are being monitored by the Amgen cybersecurity team in accordance with the governance processes detailed above. 56
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Risk Factors— Our efforts to collaborate with or acquire other companies, products, or technology, and to integrate the operations of companies or to support the products or technology we have acquired, may not be successful, and may result in unanticipated costs, delays or failures to realize the benefits of the transactions and Item 1A.
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Risk Factors— A breakdown of our information technology systems, cyberattack or information security breach could significantly compromise the confidentiality, integrity and availability of our information technology systems, network-connected control systems and/or our data, interrupt the operation of our business and/or affect our reputation. 56

Item 2. Properties

Properties — owned and leased real estate

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Biggest changeLocation: Manufacturing Administrative R&D Sales & marketing Warehouse Distribution center Thousand Oaks, CA (1) x x x x x x Juncos, Puerto Rico x x x x West Greenwich, RI x x x Deerfield, IL x x x Cambridge, MA x New Albany, OH x x x San Francisco, CA x Tampa, FL x x Louisville, KY x x Other U.S. cities (2) x x x ROW Location: Manufacturing Administrative R&D Sales & marketing Warehouse Distribution center Brazil x x Canada x x x China x x Denmark x x x Germany x x x Iceland x x India x Ireland x x x x x Netherlands x x x x x Singapore x x x x United Kingdom x x x Other countries (2) x x x x ____________ (1) Corporate headquarters (2) Includes smaller properties in other U.S. and ROW locations, primarily for administrative and sales & marketing Excluded from the information above are (i) undeveloped land and leased properties that have been abandoned and (ii) certain buildings we still own but that are no longer used in our business.
Biggest changeLocation: Manufacturing Administrative R&D Sales and marketing Warehouse Distribution center Thousand Oaks, CA (1) x x x x x x Juncos, Puerto Rico x x x x West Greenwich, RI x x x Deerfield, IL x x x Cambridge, MA x New Albany, OH x x x San Francisco, CA x Tampa, FL x x Louisville, KY x x Other U.S. cities (2) x x x ROW Location: Manufacturing Administrative R&D Sales and marketing Warehouse Distribution center Canada x x x China x x Denmark x x x Germany x x x Iceland x x India x Ireland x x x x x Netherlands x x x x x Singapore x x x x Other countries (2) x x x x ____________ (1) Corporate headquarters.
Item 2. PROPERTIES As of December 31, 2024, we owned or leased approximately 160 properties. The locations and primary functions of significant properties are summarized in the following tables: U.S.
Item 2. PROPERTIES As of December 31, 2025, we owned or leased approximately 160 properties. The locations and primary functions of significant properties are summarized in the following tables: U.S.
See Item 1A. Risk Factors for a discussion of the factors that could adversely impact our manufacturing operations and the global supply of our products. See Item 1. Business—Manufacturing, Distribution and Raw Materials. 57
Risk Factors for a discussion of the factors that could adversely impact our manufacturing operations and the global supply of our products. See Item 1. Business—Manufacturing, Distribution and Raw Materials.
Furthermore, in January 2025, we broke ground on our second drug substance manufacturing facility in Holly Springs, North Carolina. There are no material encumbrances on our owned properties. We believe our facilities are suitable for their intended uses and, in conjunction with our third-party contract manufacturing agreements, provide adequate capacity and are sufficient to meet our expected needs.
There are no material encumbrances on our owned properties. We believe our facilities are suitable for their intended uses and, in conjunction with our third-party contract manufacturing agreements, provide adequate capacity and are sufficient to meet our expected needs. See Item 1A.
Additionally, in 2024 we received FDA licensure of our manufacturing facility in New Albany, Ohio; opened a new technology and innovation site in India; and continued to progress on the construction of our first drug substance manufacturing facility in Holly Springs, North Carolina.
Additionally, in 2025 we broke ground on our second drug substance manufacturing facility in Holly Springs, North Carolina; announced expansions of our manufacturing network in Ohio and the U.S. territory of Puerto Rico; and broke ground on a new, state-of-the-art science and innovation center at our corporate headquarters in Thousand Oaks, California.
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(2) Includes smaller properties in other U.S. and ROW locations, primarily for administrative and sales and marketing. Excluded from the information above are (i) undeveloped land and leased properties that have been abandoned and (ii) certain buildings we still own but that are no longer used in our business.

Item 3. Legal Proceedings

Legal Proceedings — active lawsuits and investigations

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Biggest changeItem 3. LEGAL PROCEEDINGS Certain of the legal proceedings in which we are involved are discussed in Part IV—Note 20, Contingencies and commitments, to the Consolidated Financial Statements and are hereby incorporated by reference. Item 4. MINE SAFETY DISCLOSURES Not applicable. 58 PART II
Biggest changeItem 3. LEGAL PROCEEDINGS Certain of the legal proceedings in which we are involved are discussed in Part IV—Note 20, Contingencies and commitments, to the Consolidated Financial Statements and are hereby incorporated by reference. 57 Item 4. MINE SAFETY DISCLOSURES Not applicable. 58 PART II

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

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Biggest changeThe historical stock price performance of the Company’s common stock shown in the performance graph is not necessarily indicative of future stock price performance. 12/31/2019 12/31/2020 12/31/2021 12/31/2022 12/31/2023 12/31/2024 Amgen (AMGN) $100.00 $98.00 $98.86 $119.11 $135.21 $126.14 Amex Biotech (BTK) $100.00 $113.57 $109.57 $105.18 $108.20 $114.95 Amex Pharmaceutical (DRG) $100.00 $108.73 $134.15 $144.55 $155.72 $163.62 Standard & Poor’s 500 (SPX) $100.00 $118.39 $152.34 $124.66 $157.49 $196.50 The material in the above performance graph is not soliciting material, is not deemed filed with the SEC and is not incorporated by reference in any filing of the Company under the Securities Act or the Exchange Act, whether made on, before or after the date of this filing and irrespective of any general incorporation language in such filing. 59 Stock repurchase program During the year ended December 31, 2024, we had one outstanding stock repurchase program, under which repurchase activity was as follows: Total number of shares purchased Average price paid per share Total number of shares purchased as part of publicly announced program Maximum dollar value that may yet be purchased under the program October 1–October 31 — — $ 6,979,263,848 November 1–November 30 — — $ 6,979,263,848 December 1–December 31 718,799 $ 278.26 718,799 $ 6,779,253,902 718,799 718,799 January 1–December 31 (1) 718,799 $ 278.26 718,799 ____________ (1) During the year ended December 31, 2024, the Company purchased an additional 1,225 shares at an average price paid of $323.34 per share from staff members to satisfy federal law compliance obligations.
Biggest changeThe historical stock price performance of the Company’s common stock shown in the performance graph is not necessarily indicative of future stock price performance. 12/31/2020 12/31/2021 12/31/2022 12/31/2023 12/31/2024 12/31/2025 Amgen (AMGN) $100.00 $100.87 $121.54 $137.97 $128.71 $166.88 Amex Biotech (BTK) $100.00 $96.48 $92.61 $95.27 $101.21 $126.28 Amex Pharmaceutical (DRG) $100.00 $123.37 $132.94 $143.21 $150.48 $186.40 Standard & Poor’s 500 (SPX) $100.00 $128.68 $105.29 $133.03 $165.98 $195.62 The material in the above performance graph is not soliciting material, is not deemed filed with the SEC and is not incorporated by reference in any filing of the Company under the Securities Act or the Exchange Act, whether made on, before or after the date of this filing and irrespective of any general incorporation language in such filing. 59 Stock repurchase program During the year ended December 31, 2025, we had one outstanding stock repurchase program, under which repurchase activity was as follows: Total number of shares purchased Average price paid per share Total number of shares purchased as part of publicly announced program Maximum dollar value that may yet be purchased under the program October 1–October 31 — $ — — $ 6,779,253,902 November 1–November 30 — $ — — $ 6,779,253,902 December 1–December 31 — $ — — $ 6,779,253,902 — — January 1–December 31 (1) — $ — — ____________ (1) During the year ended December 31, 2025, the Company purchased 1,700 shares at an average price paid of $284.67 per share from staff members to satisfy federal law compliance obligations.
These shares were not repurchased under our stock repurchase program. Dividends For the years ended December 31, 2024 and 2023, we paid quarterly dividends. We expect to continue to pay quarterly dividends, although the amount and timing of any future dividends are subject to approval by our Board of Directors.
These shares were not repurchased under our stock repurchase program. Dividends For the years ended December 31, 2025 and 2024, we paid quarterly dividends. We expect to continue to pay quarterly dividends, although the amount and timing of any future dividends are subject to approval by our Board of Directors.
Performance graph The following graph shows the value of an investment of $100 on December 31, 2019, in each of Amgen common stock, the Amex Biotech Index, the Amex Pharmaceutical Index and Standard & Poor’s 500 Index. All values assume reinvestment of the pretax value of dividends and are calculated as of December 31 of each year.
Performance graph The following graph shows the value of an investment of $100 on December 31, 2020, in each of Amgen common stock, the Amex Biotech Index, the Amex Pharmaceutical Index and Standard & Poor’s 500 Index. All values assume reinvestment of the pretax value of dividends and are calculated as of December 31 of each year.
Item 5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES Common stock Our common stock trades on the Nasdaq Global Select Market under the symbol AMGN. As of February 11, 2025, there were approximately 4,047 holders of record of our common stock.
Item 5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES Common stock Our common stock trades on the Nasdaq Global Select Market under the symbol AMGN. As of February 10, 2026, there were approximately 3,824 holders of record of our common stock.

Item 7. Management's Discussion & Analysis

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

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Biggest changeOperating expenses increased for 2024, driven by higher amortization expense from Horizon acquisition-related assets, higher R&D and SG&A expenses, including expenses from the acquired Horizon business, and higher profit share and royalty expense. 63 Results of Operations Product sales Worldwide product sales were as follows (dollar amounts in millions): Year ended December 31, 2024 Change Year ended December 31, 2023 Change Year ended December 31, 2022 Prolia $ 4,374 8 % $ 4,048 12 % $ 3,628 ENBREL 3,316 (10) % 3,697 (10) % 4,117 XGEVA 2,225 5 % 2,112 5 % 2,014 Repatha 2,222 36 % 1,635 26 % 1,296 Otezla 2,126 (3) % 2,188 (4) % 2,288 TEPEZZA (1) 1,851 * 448 N/A — EVENITY 1,563 35 % 1,160 47 % 787 KYPROLIS 1,503 7 % 1,403 13 % 1,247 Nplate 1,456 (1) % 1,477 13 % 1,307 Aranesp 1,342 (1) % 1,362 (4) % 1,421 BLINCYTO 1,216 41 % 861 48 % 583 KRYSTEXXA (1) 1,185 * 272 N/A — Vectibix 1,045 6 % 984 10 % 893 TEZSPIRE 972 71 % 567 * 170 Other products (2) 5,630 20 % 4,696 (7) % 5,050 Total product sales $ 32,026 19 % $ 26,910 9 % $ 24,801 Total U.S. $ 23,301 21 % $ 19,272 9 % $ 17,743 Total ROW 8,725 14 % 7,638 8 % 7,058 Total product sales $ 32,026 19 % $ 26,910 9 % $ 24,801 * Change in excess of 100% N/A = not applicable ____________ (1) TEPEZZA and KRYSTEXXA were acquired from our Horizon acquisition on October 6, 2023, and include product sales in the periods after the acquisition date.
Biggest changeRisk Factors, of this Annual Report on Form 10-K. 63 Results of operations Product sales Worldwide product sales were as follows (dollar amounts in millions): Year ended December 31, 2025 Change Year ended December 31, 2024 Change Year ended December 31, 2023 Prolia $ 4,414 1 % $ 4,374 8 % $ 4,048 Repatha 3,016 36 % 2,222 36 % 1,635 Otezla 2,265 7 % 2,126 (3) % 2,188 ENBREL 2,226 (33) % 3,316 (10) % 3,697 EVENITY 2,100 34 % 1,563 35 % 1,160 XGEVA 2,084 (6) % 2,225 5 % 2,112 TEPEZZA (1) 1,903 3 % 1,851 * 448 BLINCYTO 1,559 28 % 1,216 41 % 861 Nplate 1,524 5 % 1,456 (1) % 1,477 TEZSPIRE (2) 1,478 52 % 972 71 % 567 KYPROLIS 1,412 (6) % 1,503 7 % 1,403 Aranesp 1,389 4 % 1,342 (1) % 1,362 KRYSTEXXA (1) 1,340 13 % 1,185 * 272 Vectibix 1,175 12 % 1,045 6 % 984 Other products (3) 7,263 29 % 5,630 20 % 4,696 Total product sales $ 35,148 10 % $ 32,026 19 % $ 26,910 Total U.S. $ 25,656 10 % $ 23,301 21 % $ 19,272 Total ROW 9,492 9 % 8,725 14 % 7,638 Total product sales $ 35,148 10 % $ 32,026 19 % $ 26,910 * Change in excess of 100% ____________ (1) TEPEZZA and KRYSTEXXA were acquired from our Horizon acquisition on October 6, 2023, and include product sales in the periods after the acquisition date.
These categories are described below: Category Description Research and early pipeline R&D expenses incurred in activities substantially in support of early research through the completion of phase 1 clinical trials, including drug discovery, toxicology, pharmacokinetics and drug metabolism and process development Later-stage clinical programs R&D expenses incurred in or related to phase 2 and phase 3 clinical programs intended to result in registration of a new product or a new indication for an existing product primarily in the United States or the EU Marketed products R&D expenses incurred in support of the Company’s marketed products that are authorized to be sold primarily in the United States or the EU.
These categories are described below: Category Description Research and Early Pipeline R&D expenses incurred in activities substantially in support of early research through the completion of Phase 1 clinical trials, including drug discovery, toxicology, pharmacokinetics and drug metabolism and process development Later-Stage Clinical Programs R&D expenses incurred in or related to Phase 2 and Phase 3 clinical programs intended to result in registration of a new product or a new indication for an existing product primarily in the United States or the EU Marketed Product Support R&D expenses incurred in support of the Company’s marketed products that are authorized to be sold primarily in the United States or the EU.
Cash provided by operating activities increased in 2024 as compared to 2023 due to higher net income after adjustments for noncash items and timing of working capital items primarily driven by higher collections in the fourth quarter.
Cash provided by operating activities increased in 2024 as compared to 2023 due to higher net income after adjustments for noncash items and the timing of working capital items primarily driven by higher collections in the fourth quarter of 2024.
We believe our estimations of future cash flows used for assessing impairment of long-lived assets are based on reasonable assumptions given the facts and circumstances as of the related dates of the assessments. 80 Recently Issued Accounting Standards See Part IV—Note 1, Summary of significant accounting policies, to the Consolidated Financial Statements for a discussion of recently issued accounting pronouncements.
We believe our estimations of future cash flows used for assessing impairment of long-lived assets are based on reasonable assumptions given the facts and circumstances as of the related dates of the assessments. Recently issued accounting standards See Part IV—Note 1, Summary of significant accounting policies, to the Consolidated Financial Statements for a discussion of recently issued accounting pronouncements. 80
These models require the use of significant estimates and assumptions, including but not limited to: • determining the timing and expected costs to complete in-process projects, taking into account the stage of completion at the acquisition date; • projecting the probability and timing of obtaining marketing approval from the FDA and other regulatory agencies for product candidates; • estimating the timing of and future net cash flows from product sales resulting from completed products and in-process projects; and • developing appropriate discount rates to calculate the present values of the cash flows.
These models require the use of significant estimates and assumptions, including but not limited to: 79 • determining the timing and expected costs to complete in-process projects, taking into account the stage of completion at the acquisition date; • projecting the probability and timing of obtaining marketing approval from the FDA and other regulatory agencies for product candidates; • estimating the timing of and future net cash flows from product sales resulting from completed products and in-process projects; and • developing appropriate discount rates to calculate the present values of the cash flows.
See Part IV—Note 10, Investments; Note 16, Financing arrangements; and Note 17, Stockholders’ equity, to the Consolidated Financial Statements. 75 Capital requirements We have material cash requirements to pay third parties under various contractual obligations discussed below.
See Part IV—Note 10, Investments; Note 16, Financing arrangements; and Note 17, Stockholders’ equity, to the Consolidated Financial Statements. Capital requirements We have material cash requirements to pay third parties under various contractual obligations discussed below.
We helped launch the biotechnology industry more than 40 years ago and have grown to be one of the world’s leading independent biotechnology companies. Our robust pipeline includes potential first-in-class medicines at all stages of development. Our principal products are Prolia, ENBREL, XGEVA, Repatha, Otezla, TEPEZZA, EVENITY, KYPROLIS, Nplate, Aranesp, BLINCYTO, KRYSTEXXA, Vectibix and TEZSPIRE.
We helped launch the biotechnology industry more than 45 years ago and have grown to be one of the world’s leading independent biotechnology companies. Our robust pipeline includes potential first-in-class medicines at all stages of development. Our principal products are Prolia, Repatha, Otezla, ENBREL, EVENITY, XGEVA, TEPEZZA, BLINCYTO, Nplate, TEZSPIRE, KYPROLIS, Aranesp, KRYSTEXXA and Vectibix.
We must grow sales from existing and new products to achieve revenue growth and to offset revenue losses caused by products’ loss of their exclusivity or launches of competing products. For example, our patents for RANKL antibodies, including sequences, for Prolia and XGEVA expire in February 2025 in the United States and in November 2025 in select countries in Europe.
We must grow sales from existing and new products to achieve revenue growth and to offset revenue losses caused by products’ loss of their exclusivity or launches of competing products. For example, our patents for RANKL antibodies, including sequences, for Prolia and XGEVA expired in February 2025 in the United States and in November 2025 in select countries in Europe.
For information on scheduled debt maturities and payments under derivative contracts associated with our long-term debt obligations, see Part IV—Note 16, Financing arrangements, and Note 19, Derivative instruments, to the Consolidated Financial Statements. We are obligated to make payments for operating leases, including rental commitments on abandoned leases and leases that have not yet commenced.
For information on scheduled debt maturities and payments under derivative contracts associated with our long-term debt obligations, see Part IV—Note 16, Financing arrangements, and Note 19, Derivative instruments, to the Consolidated Financial Statements. We are obligated to make payments for operating leases, including rental commitments on unoccupied leases and leases that have not yet commenced.
The carrying values of our long-term borrowings are net of fair value adjustments for interest rate swaps and unamortized discounts, premiums and offering costs. As of December 31, 2024, S&P, Moody’s and Fitch assigned credit ratings to our outstanding senior notes of BBB+, Baa1 and BBB, respectively, which are considered investment grade.
The carrying values of our long-term borrowings are net of fair value adjustments for interest rate swaps and unamortized discounts, premiums and offering costs. As of December 31, 2025, S&P, Moody’s and Fitch assigned credit ratings to our outstanding senior notes of BBB+, Baa1 and BBB+, respectively, which are considered investment grade.
Annual commitment fees for this agreement are 0.09% of the unused portion of the facility based on our current credit rating.
Annual commitment fees for this agreement are 0.09% of the 74 unused portion of the facility based on our current credit rating.
We were in compliance with all applicable covenants under these arrangements as of December 31, 2024. These financing arrangements are more fully discussed in Part IV—Note 16, Financing arrangements, and Note 19, Derivative instruments, to the Consolidated Financial Statements.
We were in compliance with all applicable covenants under these arrangements as of December 31, 2025. These financing arrangements are more fully discussed in Part IV—Note 16, Financing arrangements, and Note 19, Derivative instruments, to the Consolidated Financial Statements.
During 2024, 2023 and 2022, we did not issue any commercial paper. No commercial paper was outstanding as of December 31, 2024 and 2023. In 2023, we amended and restated our syndicated, unsecured, revolving credit agreement, under which we may borrow up to $4.0 billion for general corporate purposes, including as a liquidity backstop for our commercial paper program.
We did not issue any commercial paper during 2025, 2024 or 2023, and no commercial paper was outstanding as of December 31, 2025 and 2024. In 2023, we amended and restated our syndicated, unsecured, revolving credit agreement, under which we may borrow up to $4.0 billion for general corporate purposes, including as a liquidity backstop for our commercial paper program.
We intend to continue investing in our business while reducing our debt and returning capital to stockholders through the payment of cash dividends and stock repurchases. This reflects our desire to optimize our cost of capital and our confidence in the future cash flows of our business.
We intend to continue investing in our business while returning capital to stockholders through the payment of cash dividends and stock repurchases. This reflects our desire to optimize our cost of capital and our confidence in the future cash flows of our business.
Additionally, with public and private healthcare-provider focus, the industry continues to be subject to cost containment measures and significant pricing pressures, resulting in net price declines. Moreover, provisions of the IRA, as well as the 340B Program, have affected, and are likely to continue to affect, our business.
Additionally, with public and private healthcare-provider focus, the industry continues to be subject to cost containment measures and significant pricing pressures, resulting in net price declines. Moreover, provisions of the IRA, as well as the expanded utilization of the 340B Program, have negatively affected, and are likely to continue to negatively affect, our business.
In addition, the timing and amount of stock repurchases may also be affected by our overall level of cash, stock price and blackout periods, during which we are restricted from repurchasing stock. The manner of stock repurchases may include block purchases, tender offers, ASRs and market transactions.
In addition, the timing and amount of stock repurchases may also be affected by our overall level of cash, stock price and blackout periods, during which we are restricted from repurchasing stock. The manner of stock repurchases may include block purchases, tender offers, accelerated share repurchases and market transactions.
The 2023 net unrealized gains on our strategic equity investments were principally composed of amounts recognized on our BeiGene investment in the first quarter of 2023 as a result of a change from the equity method of accounting to recording this investment at fair value with changes in fair value recognized in earnings.
The 2023 net unrealized gains on equity investments were principally composed of amounts recognized on our BeOne investment in the first quarter of 2023 as a result of a change from the equity method of accounting to recording this investment at fair value with changes in fair value recognized in earnings.
As of both December 31, 2024 and 2023, we had interest rate swap contracts with an aggregate notional amount of $6.7 billion.
As of both December 31, 2025 and 2024, we had interest rate swap contracts with an aggregate notional amount of $6.7 billion.
As KRYSTEXXA was acquired on October 6, 2023, there were no recorded product sales in the periods prior to the acquisition date.
As KRYSTEXXA was acquired on October 6, 2023, there were no recorded product sales in the period prior to the acquisition date.
We continue to believe our accrual for income tax liabilities is appropriate based on past experience, interpretations of tax law, application of the tax law to our facts and judgments about potential actions by tax authorities; however, due to the complexity of the provision for income taxes and uncertain resolution of these matters, the ultimate outcome of any tax matters may result in payments substantially greater than amounts accrued and could have a material adverse impact on our consolidated financial statements. 72 See Part I, Item 1A.
We continue to believe our accrual for income tax liabilities is appropriate based on past experience, interpretations of tax law, application of the tax law to our facts and judgments about potential actions by tax authorities; however, due to the complexity of the provision for income taxes and uncertain resolution of these matters, the ultimate outcome of any tax matters may result in payments substantially greater than amounts accrued and could have a material adverse impact on our consolidated financial statements.
Research and development The Company groups all of its R&D activities and related expenditures into three categories: (i) research and early pipeline, (ii) later-stage clinical programs and (iii) marketed products.
Research and development The Company groups all of its R&D activities and related expenditures into three categories: (i) Research and Early Pipeline, (ii) Later-Stage Clinical Programs and (iii) Marketed Product Support.
Any additional tax that could be imposed for the years 2013–2015 would be reduced by up to approximately $2.2 billion of repatriation tax previously accrued on our foreign earnings. We firmly believe that the IRS positions set forth in the 2010–2012 and 2013–2015 Notices are without merit. We are contesting the 2010–2012 and 2013–2015 Notices through the judicial process.
Any additional tax that could be imposed for the years 2013–2015 would be reduced by up to approximately $2.2 billion of repatriation tax previously accrued and paid on our foreign earnings. We firmly believe that the IRS positions set forth in the 2010–2012 and 2013–2015 Notices are without merit.
Any additional tax that could be imposed for the years 2013–2015 would be reduced by up to approximately $2.2 billion of repatriation tax previously accrued on our foreign earnings. We firmly believe that the IRS positions set forth in the 2010–2012 and 2013–2015 Notices are without merit. We are contesting the 2010–2012 and 2013–2015 Notices through the judicial process.
Any additional tax that could be imposed for the years 2013–2015 would be reduced by up to approximately $2.2 billion of repatriation tax previously accrued and paid on our foreign earnings. We firmly believe that the IRS positions set forth in the 2010–2012 and 2013–2015 Notices are without merit.
We also market a number of other products, including but not limited to AMJEVITA/AMGEVITA, MVASI, Neulasta, RAVICTI, UPLIZNA, Parsabiv, LUMAKRAS/LUMYKRAS, Aimovig, TAVNEOS, PROCYSBI, EPOGEN and IMDELLTRA. For additional information about our products, see Part I, Item 1. Business—Marketing, Distribution and Selected Marketed Products.
We also market a number of other products, including but not limited to MVASI, PAVBLU, UPLIZNA, IMDELLTRA/IMDYLLTRA, AMJEVITA/AMGEVITA, TAVNEOS, Neulasta, LUMAKRAS/LUMYKRAS, RAVICTI, Parsabiv, Aimovig, WEZLANA/WEZENLA and PROCYSBI. For additional information about our products, see Part I, Item 1. Business—Marketing, Distribution and Selected Marketed Products.
Risk Factors— Global economic conditions may negatively affect us and may magnify certain risks that affect our business . Financing arrangements To help meet our liquidity requirements, we have entered into various financing arrangements. The noncurrent portions of our long-term borrowings as of December 31, 2024 and 2023, were $56.5 billion and $63.2 billion, respectively.
Risk Factors— Global economic conditions may negatively affect us and may magnify certain risks that affect our business . Financing arrangements To help meet our liquidity requirements, we have entered into various financing arrangements. The noncurrent portions of our long-term borrowings as of December 31, 2025 and 2024, were $50.0 billion and $56.5 billion, respectively.
As of December 31, 2024 and 2023, no amounts were outstanding under this facility.
As of December 31, 2025 and 2024, no amounts were outstanding under this facility.
As of December 31, 2024, we have purchase obligations of $5.7 billion primarily related to (i) R&D commitments (including those related to clinical trials) for new and existing products, (ii) capital expenditures and (iii) open purchase orders for the acquisition of goods and services in the ordinary course of business.
As of December 31, 2025, we have purchase obligations of approximately $6.9 billion primarily related to (i) R&D commitments (including those related to clinical trials) for new and existing products, (ii) capital expenditures and (iii) open purchase orders for the acquisition of goods and services in the ordinary course of business.
Except with respect to the fair value of the contingent consideration of approximately $106 million as of December 31, 2024, these obligations are not recorded on our Consolidated Balance Sheets. As of December 31, 2024, the maximum amount that may be payable in the future for agreements we have entered into with third parties is $5.6 billion.
Except with respect to the fair value of the contingent consideration of approximately $161 million as of December 31, 2025, these obligations are not recorded on our Consolidated Balance Sheets. As of December 31, 2025, the maximum amount that may be payable in the future for agreements we have entered into with third parties is approximately $7.2 billion.
Further, the first quarter of a year historically represents the lowest product sales quarter for the year, in part due to plan changes, insurance reverifications and higher co-pay expenses as U.S. patients work through deductibles, particularly for products acquired through pharmacy benefit programs.
Further, the first quarter of a year historically represents the lowest product sales quarter for the year, in part due to plan changes, insurance reverifications and higher co-pay expenses as U.S. patients work through deductibles, including for ENBREL and Otezla, and to a lesser extent for KRYSTEXXA, TEZSPIRE and Repatha, particularly for products acquired through pharmacy benefit programs.
These are ongoing adjustments that are likely to occur in the future. We are a vertically integrated enterprise with operations in the United States and various foreign jurisdictions. In the jurisdictions where we conduct operations, we are subject to income tax based on the tax laws and principles of such jurisdictions and on the functions, risks and activities performed therein.
We are a vertically integrated enterprise with operations in the United States and various foreign jurisdictions. In the jurisdictions where we conduct operations, we are subject to income tax based on the tax laws and principles of such jurisdictions and on the functions, risks and activities performed therein.
Financing Cash used in financing activities during 2024 was primarily due to the payment of dividends of $4.8 billion, the repayment and extinguishment of debt of $3.6 billion and $659 million, respectively, and payments to repurchase our common stock of $200 million.
Financing Cash used in financing activities during 2025 was primarily due to the repayment and extinguishment of debt of $5.0 billion and $683 million, respectively, and the payment of dividends of $5.1 billion. 75 Cash used in financing activities during 2024 was primarily due to the payment of dividends of $4.8 billion, the repayment and extinguishment of debt of $3.6 billion and $659 million, respectively, and payments to repurchase common stock of $200 million.
Cash flows Our summarized cash flow activity was as follows (in millions): Years ended December 31, 2024 2023 2022 Net cash provided by operating activities $ 11,490 $ 8,471 $ 9,721 Net cash used in investing activities $ (1,046) $ (26,204) $ (6,044) Net cash (used in) provided by financing activities $ (9,415) $ 21,048 $ (4,037) Operating Cash provided by operating activities has been and is expected to continue to be our primary recurring source of funds.
Cash flows Our summarized cash flow activity was as follows (in millions): Years ended December 31, 2025 2024 2023 Net cash provided by operating activities $ 9,958 $ 11,490 $ 8,471 Net cash used in investing activities $ (1,943) $ (1,046) $ (26,204) Net cash (used in) provided by financing activities $ (10,859) $ (9,415) $ 21,048 Operating Cash provided by operating activities has been and is expected to continue to be our primary recurring source of funds.
In December 2024, the Board of Directors declared a cash dividend of $2.38 per share of common stock for the first quarter of 2025, an increase of 6% over the same period in the prior year, to be paid in March 2025. We also returned capital to stockholders through our stock repurchase program.
In December 2025, the Board of Directors declared a cash dividend of $2.52 per share of common stock for the first quarter of 2026, an increase of 6% over the same period in the prior year, which will be paid in March 2026. 73 We also return capital to stockholders through our stock repurchase program.
Vectibix Total Vectibix sales by geographic region were as follows (dollar amounts in millions): Year ended December 31, 2024 Change Year ended December 31, 2023 Change Year ended December 31, 2022 Vectibix — U.S. $ 519 13 % $ 461 16 % $ 396 Vectibix — ROW 526 1 % 523 5 % 497 Total Vectibix $ 1,045 6 % $ 984 10 % $ 893 The increase in global Vectibix sales for 2024 was driven by higher net selling price of 8% and volume growth of 4%, partially offset by unfavorable changes to foreign currency exchange rates.
Vectibix Total Vectibix sales by geographic region were as follows (dollar amounts in millions): Year ended December 31, 2025 Change Year ended December 31, 2024 Change Year ended December 31, 2023 Vectibix — U.S. $ 604 16 % $ 519 13 % $ 461 Vectibix — ROW 571 9 % 526 1 % 523 Total Vectibix $ 1,175 12 % $ 1,045 6 % $ 984 The increase in global Vectibix sales for 2025 was primarily driven by volume growth. 68 The increase in global Vectibix sales for 2024 was driven by higher net selling price of 8% and volume growth of 4%, partially offset by unfavorable changes to foreign currency exchange rates.
In 2017, we received an RAR and a modified RAR from the IRS for the years 2010–2012, proposing significant adjustments that primarily relate to the allocation of profits between certain of our entities in the United States and the U.S. territory of Puerto Rico.
The legislation has multiple effective dates, with certain provisions effective in 2026 and beyond. In 2017, we received an RAR and a modified RAR from the IRS for the years 2010–2012, proposing significant adjustments that primarily relate to the allocation of profits between certain of our entities in the United States and the U.S. territory of Puerto Rico.
The increase in global Prolia sales for 2023 was primarily driven by volume growth and higher net selling price. 64 As disclosed in Part I, Item 1. Business—Marketing, Distribution and Selected Marketed Products—Patents, our patents for RANKL antibodies, including sequences, for Prolia expire in February 2025 in the United States and in November 2025 in select countries in Europe.
The increase in global XGEVA sales for 2024 was driven by higher net selling price. As disclosed in Part I, Item 1. Business—Marketing, Distribution and Selected Marketed Products, our patents for RANKL antibodies, including sequences, for XGEVA expired in February 2025 in the United States and in November 2025 in select countries in Europe.
The Board of Directors declared quarterly cash dividends of $2.25, $2.13 and $1.94 per share of common stock paid in 2024, 2023 and 2022, respectively, reflecting year-over-year increases of 6% and 10% for 2024 and 2023, respectively.
The Board of Directors declared quarterly cash dividends of $2.38, $2.25 and $2.13 per share of common stock paid in 2025, 2024 and 2023, respectively, reflecting year-over-year increases of 6% for both 2025 and 2024.
Includes clinical trials designed to gather information on product safety (certain of which may be required by regulatory authorities) and their product characteristics after regulatory approval has been obtained, as well as the costs of obtaining regulatory approval of a product in a new market after approval in either the United States or the EU has been obtained 70 R&D expense by category was as follows (in millions): Years ended December 31, 2024 2023 2022 Research and early pipeline $ 1,534 $ 1,584 $ 1,611 Later-stage clinical programs 2,830 1,898 1,627 Marketed products 1,600 1,302 1,196 Total R&D expense $ 5,964 $ 4,784 $ 4,434 The increase in R&D expense for 2024 was driven by higher spend in later-stage clinical programs and marketed product support, including Horizon-acquired programs.
Includes clinical trials designed to gather information on product safety (certain of which may be required by regulatory authorities) and their product characteristics after regulatory approval has been obtained, as well as the costs of obtaining regulatory approval of a product in a new market after approval in either the United States or the EU has been obtained 70 R&D expense by category was as follows (in millions): Years ended December 31, 2025 2024 2023 Research and Early Pipeline $ 1,732 $ 1,534 $ 1,584 Later-Stage Clinical Programs 4,281 2,830 1,898 Marketed Product Support 1,259 1,600 1,302 Total R&D expense $ 7,272 $ 5,964 $ 4,784 The increase in R&D expense for 2025 was driven by investments in Later-Stage Clinical Programs, including those related to MariTide, and in Research and Early Pipeline, partially offset by lower spend in Marketed Product Support.
For the years ended December 31, 2024, 2023 and 2022, total sales deductions were 52%, 53% and 51% of gross product sales, respectively. The increase in the total sales deductions balance as of December 31, 2024, compared with December 31, 2023, was primarily driven by higher gross sales.
For the years ended December 31, 2025, 2024 and 2023, total sales deductions were 54%, 52% and 53% of gross product sales, respectively. The increase in the total sales deductions balance as of December 31, 2025, compared with December 31, 2024, was primarily driven by an increase in gross sales and timing of payments.
The increase in global Repatha sales for 2023 was driven by volume growth, partially offset by lower net selling price. 65 For 2025, we expect lower declines in net selling price. For a discussion of ongoing litigation related to Repatha, see Part IV—Note 20, Contingencies and commitments, to the Consolidated Financial Statements.
The increase in global Repatha sales for 2024 was primarily driven by volume growth of 43%, partially offset by lower net selling price of 10%. For a discussion of ongoing litigation related to Repatha, see Part IV—Note 20, Contingencies and commitments, to the Consolidated Financial Statements.
A majority of the increase in expenditures relates to expansion of manufacturing capacity to enable supply of products and product candidates.
A majority of the increase in expenditures relates to construction costs for new plants and expansion of manufacturing capacity to enable supply of products and product candidates.
Risk Factors— We could be subject to additional tax liabilities, including from an adverse outcome in our ongoing tax dispute with the IRS and other tax examinations, enactment of the OECD minimum corporate tax rate agreement and the adoption and interpretation of new tax legislation, and we anticipate additional tax liabilities from certain provisions of the 2017 Tax Act that will go into effect in 2026; such tax liabilities could adversely affect our profitability and results of operations.
Risk Factors— We could be subject to additional tax liabilities, including from an adverse outcome in our ongoing tax dispute with the IRS and other tax examinations, enactment of the OECD minimum corporate tax rate agreement and the adoption and interpretation of new tax legislation, including OB3. Such tax liabilities could adversely affect our profitability and results of operations.
To hedge our exposure to foreign currency exchange rate risk associated with certain of our long-term notes denominated in foreign currencies, we entered into cross-currency swap contracts, which effectively convert the interest payments and principal repayment of the respective notes from euros, pounds sterling and Swiss francs to U.S. dollars.
To hedge our exposure to foreign currency exchange rate risk associated with certain of our long-term notes denominated in foreign currencies, we entered into cross-currency swap contracts, which effectively converted the interest payments and principal repayment of the respective notes from euros and pounds sterling to U.S. dollars. These cross-currency swap contracts qualify and are designated as cash flow hedges.
To continue on our path to greater environmental sustainability, in January 2021 we announced a new set of long-term environmental targets to achieve by 2027, including achieving carbon neutrality, reducing water consumption by 40% and reducing waste disposed by 75%. 2,3 Our long-term success depends, to a great extent, on our ability to continue to discover, develop and commercialize innovative products and acquire or collaborate on therapies currently in development by other companies.
As part of our environmental sustainability efforts, we have established long-term targets to meet by 2027, including achieving carbon neutrality, reducing water consumption by 40% and reducing waste disposed by 75%. 2,3 Our long-term success depends, to a great extent, on our ability to continue to discover, develop and commercialize innovative products and acquire or collaborate on therapies currently in development by other companies.
Cash used in investing activities during 2023 was primarily due to $27.0 billion of net cash used for the purchase of Horizon and $1.1 billion of capital expenditures, partially offset by net cash inflows related to marketable securities of $1.7 billion.
Cash used in investing activities during 2023 was primarily due to $27.0 billion of net cash used for the purchase of Horizon and $1.1 billion of capital expenditures, partially offset by net cash inflows related to marketable securities of $1.7 billion. We currently estimate 2026 investments in capital projects to be approximately $2.6 billion.
Tax Court to contest a Notice for the years 2013–2015 that we previously reported receiving in April 2022 that seeks to increase our U.S. taxable income for the years 2013–2015 by an amount that would result in additional federal tax of approximately $5.1 billion, plus interest. In addition, the Notice asserts penalties of approximately $2.0 billion.
The Notice seeks to increase our U.S. taxable income for the years 2013–2015 by an amount that would result in additional federal tax of approximately $5.1 billion, plus interest, and asserts penalties of approximately $2.0 billion.
Tax Court to contest a Notice for the years 2013–2015 that we previously reported receiving in April 2022 that seeks to increase our U.S. taxable income for the years 2013–2015 by an amount that would result in additional federal tax of approximately $5.1 billion, plus interest. In addition, the Notice asserts penalties of approximately $2.0 billion.
The Notice seeks to increase our U.S. taxable income for the years 2013–2015 by an amount that would result in additional federal tax of approximately $5.1 billion, plus interest, and asserts penalties of approximately $2.0 billion.
Excluding the U.S. government orders from this comparison, global Nplate sales increased 12% for 2024, driven by volume growth of 8% and higher net selling price of 6%. The increase in global Nplate sales for 2023 was primarily driven by volume growth, including U.S. government orders totaling $286 million.
Excluding the U.S. government orders from this comparison, global Nplate sales increased 12% for 2024, driven by volume growth of 8% and higher net selling price of 6%.
Amounts recorded in Accrued liabilities in the Consolidated Balance Sheets for sales deductions were as follows (in millions): Rebates Chargebacks Other deductions Total Balance as of December 31, 2021 $ 4,147 $ 797 $ 230 $ 5,174 Amounts charged against product sales 12,500 10,630 2,288 25,418 Payments (11,768) (10,578) (2,260) (24,606) Balance as of December 31, 2022 4,879 849 258 5,986 Additions (1) 263 24 39 326 Amounts charged against product sales 14,328 13,349 2,533 30,210 Payments (13,634) (13,125) (2,492) (29,251) Balance as of December 31, 2023 5,836 1,097 338 7,271 Amounts charged against product sales 17,404 14,882 3,060 35,346 Payments (16,423) (14,817) (2,972) (34,212) Balance as of December 31, 2024 $ 6,817 $ 1,162 $ 426 $ 8,405 ____________ (1) Represents sales deductions assumed from the Horizon acquisition.
Amounts recorded in Accrued liabilities in the Consolidated Balance Sheets for sales deductions were as follows (in millions): Rebates Chargebacks Other deductions Total Balance as of December 31, 2022 $ 4,879 $ 849 $ 258 $ 5,986 Additions (1) 263 24 39 326 Amounts charged against product sales 14,328 13,349 2,533 30,210 Payments (13,634) (13,125) (2,492) (29,251) Balance as of December 31, 2023 5,836 1,097 338 7,271 Amounts charged against product sales 17,404 14,882 3,060 35,346 Payments (16,423) (14,817) (2,972) (34,212) Balance as of December 31, 2024 6,817 1,162 426 8,405 Amounts charged against product sales 21,697 16,988 3,298 41,983 Payments (19,675) (16,852) (3,255) (39,782) Balance as of December 31, 2025 $ 8,839 $ 1,298 $ 469 $ 10,606 ____________ (1) Represents sales deductions assumed from the Horizon acquisition.
Under this shelf registration statement, all of the securities available for issuance may be offered from time to time, with terms to be determined at the time of issuance. This shelf registration statement expires in February 2026. 74 Certain of our financing arrangements contain nonfinancial covenants.
Under this shelf registration statement, all of the securities available for issuance may be offered from time to time, with terms to be determined at the time of issuance. This shelf registration statement expired in February 2026, and our Board has approved a new shelf registration statement to replace it. Certain of our financing arrangements contain nonfinancial covenants.
For 2024, we increased our quarterly cash dividend by 6% to $2.25 per share of common stock. In December 2024, the Board of Directors declared a cash dividend of 61 $2.38 per share of common stock for the first quarter of 2025, an increase of 6% over the same period in the prior year, to be paid in March 2025.
In December 2025, the Board of Directors declared a cash dividend of $2.52 per share of common stock for the first quarter of 2026, an increase of 6% over the same period in the prior year, to be paid in March 2026.
Other operating expenses for 2023 primarily consisted of a net IPR&D intangible asset impairment charge for AMG 340 and expenses related to our restructuring plan that were both initiated and substantially completed in 2023. Other operating expenses for 2022 primarily consisted of a loss on the divestiture of Gensenta.
Other operating expenses for 2023 included a net IPR&D intangible asset impairment charge for AMG 340 and expenses related to our restructuring plan that were both initiated and substantially completed in 2023.
We expect to continue to grow our spend on later-stage clinical programs as we advance our pipeline. The increase in R&D expense for 2023 was driven by higher spend in later-stage clinical programs and marketed product support, including Horizon-acquired programs.
This increase includes the impact of business development activities in 2025. The increase in R&D expense for 2024 was driven by investments in Later-Stage Clinical Programs and Marketed Product Support, including Horizon-acquired programs. We expect to continue to grow our spend on Later-Stage Clinical Programs as we advance our pipeline.
Nplate Total Nplate sales by geographic region were as follows (dollar amounts in millions): Year ended December 31, 2024 Change Year ended December 31, 2023 Change Year ended December 31, 2022 Nplate — U.S. $ 970 (3) % $ 996 17 % $ 848 Nplate — ROW 486 1 % 481 5 % 459 Total Nplate $ 1,456 (1) % $ 1,477 13 % $ 1,307 Global Nplate sales for 2024 decreased 1% and included U.S. government orders of $128 million and $286 million for 2024 and 2023, respectively.
Nplate Total Nplate sales by geographic region were as follows (dollar amounts in millions): Year ended December 31, 2025 Change Year ended December 31, 2024 Change Year ended December 31, 2023 Nplate — U.S. $ 1,027 6 % $ 970 (3) % $ 996 Nplate — ROW 497 2 % 486 1 % 481 Total Nplate $ 1,524 5 % $ 1,456 (1) % $ 1,477 Global Nplate sales for 2025 increased 5% and included U.S. government orders of $90 million and $128 million for 2025 and 2024, respectively.
Investing Cash used in investing activities during 2024 was primarily due to $1.1 billion of capital expenditures, including construction costs for new plants in North Carolina and Ohio.
Investing Cash used in investing activities during 2025 and 2024 was primarily due to $1.9 billion and $1.1 billion, respectively, of capital expenditures, including construction costs for new plants and expansion of manufacturing capacity.
The increase in global KYPROLIS sales for 2023 was driven by volume growth.
The increase in global KYPROLIS sales for 2024 was driven by volume growth outside the United States.
Tax Court to contest two duplicate Statutory Notices of Deficiency (Notices) for the years 2010–2012 that we received in May and July 2021, which seek to increase our U.S. taxable income for the years 2010–2012 by an amount that would result in additional federal tax of approximately $3.6 billion plus interest.
The Notices seek to increase our U.S. taxable income for the years 2010–2012 by an amount that would result in additional federal tax of approximately $3.6 billion plus interest.
While it is not possible to accurately predict or determine the eventual outcomes of these items, an adverse determination in one or more of these items currently pending could have a material adverse effect on our consolidated results of operations, financial position or cash flows. 79 Valuation of assets and liabilities in connection with acquisitions We have acquired and continue to acquire intangible assets in connection with business combinations and asset acquisitions.
While it is not possible to accurately predict or determine the eventual outcomes of these items, an adverse determination in one or more of these items currently pending could have a material adverse effect on our consolidated results of operations, financial position or cash flows.
In addition, any reference to increases or decreases in inventory refers to changes in inventory held by wholesaler customers and end users (such as pharmacies). Total product sales increased 19% in 2024, primarily driven by volume growth of 23%, partially offset by declines in net selling price of 2%. U.S. volume grew 26% and ROW volume grew 17%.
In addition, any reference to increases or decreases in inventory refers to changes in inventory held by wholesaler customers and end users (such as pharmacies). Total product sales increased 10% in 2025, driven by volume growth of 13%, partially offset by declines in net selling price of 3%.
Management’s Discussion and Analysis or Financial Condition and Results of Operations—Critical Accounting Policies and Estimates, Income taxes; and Part IV—Note 7, Income taxes, to the Consolidated Financial Statements for further discussion.
Such tax liabilities could adversely affect our profitability and results of operations; Part II, Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations—Critical Accounting Policies and Estimates— Income taxes ; and Part IV—Note 7, Income taxes, to the Consolidated Financial Statements for further discussion.
ENBREL Total ENBREL sales by geographic region were as follows (dollar amounts in millions): Year ended December 31, 2024 Change Year ended December 31, 2023 Change Year ended December 31, 2022 ENBREL — U.S. $ 3,288 (10) % $ 3,650 (10) % $ 4,044 ENBREL — Canada 28 (40) % 47 (36) % 73 Total ENBREL $ 3,316 (10) % $ 3,697 (10) % $ 4,117 The decrease in ENBREL sales for 2024 was driven by lower net selling price.
ENBREL Total ENBREL sales by geographic region were as follows (dollar amounts in millions): Year ended December 31, 2025 Change Year ended December 31, 2024 Change Year ended December 31, 2023 ENBREL — U.S. $ 2,199 (33) % $ 3,288 (10) % $ 3,650 ENBREL — Canada 27 (4) % 28 (40) % 47 Total ENBREL $ 2,226 (33) % $ 3,316 (10) % $ 3,697 The decrease in ENBREL sales for 2025 was primarily driven by lower net selling price of 36% resulting from the impact of increased 340B Program mix, U.S.
(2) 916 34 % 685 5 % 650 Other — ROW (2) 217 3 % 210 (31) % 305 Total other product sales $ 5,630 20 % $ 4,696 (7) % $ 5,050 Total U.S. — other products $ 4,037 22 % $ 3,307 (8) % $ 3,606 Total ROW — other products 1,593 15 % 1,389 (4) % 1,444 Total other product sales $ 5,630 20 % $ 4,696 (7) % $ 5,050 N/A = not applicable * Change in excess of 100% ____________ (1) RAVICTI, UPLIZNA and PROCYSBI were acquired from our Horizon acquisition on October 6, 2023, and include product sales in the periods after the acquisition date.
(2) 895 (11) % 1,010 11 % 911 Other — ROW (2) 203 7 % 190 (10) % 210 Total other product sales $ 7,263 29 % $ 5,630 20 % $ 4,696 Total U.S. — other products $ 5,437 35 % $ 4,037 22 % $ 3,307 Total ROW — other products 1,826 15 % 1,593 15 % 1,389 Total other product sales $ 7,263 29 % $ 5,630 20 % $ 4,696 * Change in excess of 100% N/A = not applicable ____________ (1) UPLIZNA, RAVICTI and PROCYSBI were acquired from our Horizon acquisition on October 6, 2023, and include product sales in the periods after the acquisition date.
As disclosed in Part I, Item 1. Business—Marketing, Distribution and Selected Marketed Products—Patents, our patents for RANKL antibodies, including sequences, for XGEVA expire in February 2025 in the United States and in November 2025 in select countries in Europe. For 2025, we expect sales erosion driven by biosimilar competition.
The increase in global Prolia sales for 2024 was driven by volume growth. As disclosed in Part I, Item 1. Business—Marketing, Distribution and Selected Marketed Products, our patents for RANKL antibodies, including sequences, for Prolia expired in February 2025 in the United States and in November 2025 in select countries in Europe.
Nonoperating expenses/income and income taxes Nonoperating expenses/income and income taxes were as follows (dollar amounts in millions): Years ended December 31, 2024 2023 2022 Interest expense, net $ (3,155) $ (2,875) $ (1,406) Other income (expense), net $ 506 $ 2,833 $ (814) Provision for income taxes $ 519 $ 1,138 $ 794 Effective tax rate 11.3 % 14.5 % 10.8 % Interest expense, net The increases in Interest expense, net, in 2024 and 2023 over the respective prior years were primarily due to higher average debt outstanding and higher weighted-average fixed and floating interest rates on the debt.
Nonoperating expenses/income and income taxes Nonoperating expenses/income and income taxes were as follows (dollar amounts in millions): Years ended December 31, 2025 2024 2023 Interest expense, net $ (2,755) $ (3,155) $ (2,875) Other income, net $ 2,651 $ 506 $ 2,833 Provision for income taxes $ 1,265 $ 519 $ 1,138 Effective tax rate 14.1 % 11.3 % 14.5 % Interest expense, net The decrease in Interest expense, net, for 2025 was primarily due to lower average debt outstanding driven by deleveraging and, to a lesser extent, lower weighted-average fixed and floating interest rates on the debt.
These cross-currency swap contracts qualify and are designated as cash flow hedges. As of both December 31, 2024 and 2023, we had cross-currency swap contracts with an aggregate notional amount of $2.7 billion. As of December 31, 2024, our commercial paper program allows us to issue up to $2.5 billion of unsecured commercial paper to fund our working capital needs.
As of both December 31, 2025 and 2024, we had cross-currency swap contracts with an aggregate notional amount of $2.7 billion. In 2025, we increased the capacity of our commercial paper program from $2.5 billion to $4.0 billion, which allows us to issue up to $4.0 billion of unsecured commercial paper to fund working capital needs.
Management’s Discussion and Analysis of Financial Condition and Results of Operations—Results of Operations, Income taxes; and Part IV—Note 7, Income taxes, to the Consolidated Financial Statements for further discussion.
Such tax liabilities could adversely affect our profitability and results of operations; Part II, Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations—Results of Operations—Income taxes; and Part IV—Note 7, Income taxes, to the Consolidated Financial Statements for further discussion.
(2) Consists of product sales of our non-principal products. Future sales of our products will depend in part on the factors discussed in the Overview, Part I, Item 1. Business—Marketing, Distribution and Selected Marketed Products—Competition, Part I, Item 1. Business—Reimbursement, Part I, Item 1A. Risk Factors, and any additional factors discussed in the individual product sections below.
(2) TEZSPIRE is marketed by our collaborator AstraZeneca outside the United States. (3) Consists of product sales of our non-principal products. Future sales of our products will depend in part on the factors discussed in the Overview, Part I, Item 1. Business—Marketing, Distribution and Selected Marketed Products— Competition , Part I, Item 1. Business—Reimbursement, Part I, Item 1A.
In 2020, we received an RAR and a modified RAR from the IRS for the years 2013–2015, also proposing significant adjustments that primarily relate to the allocation of profits between certain of our entities in the United States and the U.S. territory of Puerto Rico similar to those proposed for the years 2010–2012.
Any additional tax that could be imposed for the years 2010–2012 would be reduced by up to approximately $900 million of repatriation tax previously accrued and paid on our foreign earnings. 78 In 2020, we received an RAR and a modified RAR from the IRS for the years 2013–2015, also proposing significant adjustments that primarily relate to the allocation of profits between certain of our entities in the United States and the U.S. territory of Puerto Rico similar to those proposed for the years 2010–2012.
For 2025, we expect sales erosion driven by biosimilar competition. For a discussion of ongoing litigation related to Prolia, see Part IV—Note 20, Contingencies and commitments, to the Consolidated Financial Statements.
For 2026, we expect accelerated sales erosion driven by increased competition, as multiple biosimilars have launched in the United States and ROW. For a discussion of ongoing litigation related to Prolia, see Part IV—Note 20, Contingencies and commitments, to the Consolidated Financial Statements.
These intangible assets consist primarily of technology associated with currently marketed human therapeutic products and IPR&D product candidates. Discounted cash flow models are typically used to determine the fair values of these intangible assets for purposes of allocating consideration paid to the net assets acquired in an acquisition. See Part IV—Note 4, Acquisitions and divestitures, to the Consolidated Financial Statements.
Discounted cash flow models are typically used to determine the fair values of these intangible assets for purposes of allocating consideration paid to the net assets acquired in an acquisition. See Part IV—Note 4, Acquisition, to the Consolidated Financial Statements.
XGEVA Total XGEVA sales by geographic region were as follows (dollar amounts in millions): Year ended December 31, 2024 Change Year ended December 31, 2023 Change Year ended December 31, 2022 XGEVA — U.S. $ 1,507 (1) % $ 1,527 3 % $ 1,480 XGEVA — ROW 718 23 % 585 10 % 534 Total XGEVA $ 2,225 5 % $ 2,112 5 % $ 2,014 The increases in global XGEVA sales for 2024 and 2023 were driven by higher net selling price.
XGEVA Total XGEVA sales by geographic region were as follows (dollar amounts in millions): Year ended December 31, 2025 Change Year ended December 31, 2024 Change Year ended December 31, 2023 XGEVA — U.S. $ 1,355 (10) % $ 1,507 (1) % $ 1,527 XGEVA — ROW 729 2 % 718 23 % 585 Total XGEVA $ 2,084 (6) % $ 2,225 5 % $ 2,112 The decrease in global XGEVA sales for 2025 was driven by lower volume.
Our strategy is the integrated set of actions we take to improve our competitive position in the industry. In 2024, we advanced our innovative pipeline; generated strong sales growth across our product portfolio and regions; and expanded our world-class manufacturing network. We accomplished these objectives while maintaining a strategic and disciplined approach to capital allocation.
Our strategy is the integrated set of actions we take to improve our competitive position in the industry. In 2025, we generated strong sales growth across our product portfolio and regions; advanced our innovative pipeline; and continued to expand and enhance our world-class manufacturing network.
Income taxes The decrease in our effective tax rate for 2024 compared with 2023 was primarily due to a change in earnings mix, including the net unrealized impact of our strategic equity investments, partially offset by the deferred tax adjustments associated with U.S. minimum tax on the earnings of our foreign subsidiaries.
Income taxes The increase in our effective tax rate for 2025 compared with 2024 was primarily due to a change in earnings mix, including the net unrealized gains on equity investments compared to net unrealized losses on equity investments in the prior year, partially offset by the prior-year deferred tax adjustments associated with U.S. tax on the earnings of our foreign subsidiaries and the current year Otezla intangible asset impairment charges and related tax impacts.
Macroeconomic and other challenges Uncertain macroeconomic conditions, including the risk of inflation, tariffs or trade protection measures, higher interest rates and instability in the financial system, as well as rising healthcare costs, continue to pose challenges to our business. Further, ongoing geopolitical conflicts continue to create additional uncertainty in global macroeconomic conditions.
Macroeconomic and other challenges Uncertain macroeconomic conditions, including the risk of inflation, fluctuating interest rates and instability in the financial system, as well as rising healthcare costs, continue to pose challenges to our business.
Selling, general and administrative The increase in SG&A expense for 2024 was primarily driven by expenses from the acquired Horizon business and other commercial expenses, partially offset by lower acquisition-related expenses related to the Horizon acquisition incurred in 2024.
The increase in SG&A expense for 2024 was primarily driven by expenses from the acquired Horizon business and other commercial expenses, partially offset by lower acquisition-related expenses related to the Horizon acquisition incurred in 2024. Other Other operating expenses for 2025 included Otezla intangible asset impairment charges of $1.2 billion.
(2) Consists of product sales from (i) KANJINTI, RIABNI, AVSOLA, NEUPOGEN, Corlanor, IMLYGIC, BEKEMV, PAVBLU, WEZLANA/WEZENLA and Sensipar/Mimpara; and (ii) ACTIMMUNE, RAYOS, BUPHENYL, QUINSAIR, PENNSAID and DUEXIS in the periods after our Horizon acquisition on October 6, 2023. 69 Operating expenses Operating expenses were as follows (dollar amounts in millions): Year ended December 31, 2024 Change Year ended December 31, 2023 Change Year ended December 31, 2022 Cost of sales $ 12,858 52 % $ 8,451 32 % $ 6,406 % of product sales 40.1 % 31.4 % 25.8 % % of total revenues 38.5 % 30.0 % 24.3 % Research and development $ 5,964 25 % $ 4,784 8 % $ 4,434 % of product sales 18.6 % 17.8 % 17.9 % % of total revenues 17.8 % 17.0 % 16.8 % Selling, general and administrative $ 7,096 15 % $ 6,179 14 % $ 5,414 % of product sales 22.2 % 23.0 % 21.8 % % of total revenues 21.2 % 21.9 % 20.6 % Other $ 248 (72) % $ 879 75 % $ 503 Total operating expenses $ 26,166 29 % $ 20,293 21 % $ 16,757 Cost of sales Cost of sales increased to 38.5% of total revenues for 2024, driven by higher amortization expense from Horizon acquisition-related assets and, to a lesser extent, higher profit share and royalty expense, partially offset by the prior year impact of the 2022 Puerto Rico tax law change that replaced an excise tax with an income tax beginning in 2023.
(2) Consists of product sales from (i) AVSOLA, KANJINTI, EPOGEN, RIABNI, BKEMV/BEKEMV, IMLYGIC, NEUPOGEN, Corlanor and Sensipar/Mimpara; and (ii) ACTIMMUNE, BUPHENYL, RAYOS, QUINSAIR, DUEXIS, VIMOVO and PENNSAID in the periods after our Horizon acquisition on October 6, 2023. 69 Operating expenses Operating expenses were as follows (dollar amounts in millions): Year ended December 31, 2025 Change Year ended December 31, 2024 Change Year ended December 31, 2023 Cost of sales $ 12,037 (6) % $ 12,858 52 % $ 8,451 % of product sales 34.2 % 40.1 % 31.4 % % of total revenues 32.8 % 38.5 % 30.0 % Research and development $ 7,272 22 % $ 5,964 25 % $ 4,784 % of product sales 20.7 % 18.6 % 17.8 % % of total revenues 19.8 % 17.8 % 17.0 % Selling, general and administrative $ 7,050 (1) % $ 7,096 15 % $ 6,179 % of product sales 20.1 % 22.2 % 23.0 % % of total revenues 19.2 % 21.2 % 21.9 % Other $ 1,312 * $ 248 (72) % $ 879 Total operating expenses $ 27,671 6 % $ 26,166 29 % $ 20,293 * Change in excess of 100% Cost of sales Cost of sales decreased to 32.8% of total revenues for 2025, driven by lower amortization expense from acquisition-related assets, including the fair value step-up of inventory acquired from Horizon, and lower manufacturing costs, partially offset by higher profit share expense and changes in our sales mix.
Other Other operating expenses for 2024 primarily consisted of impairment charges associated with IPR&D intangible assets related to our Teneobio acquisition in 2021 and expenses related to cost-savings initiatives incurred in 2024.
See Part IV—Note 13, Goodwill and other intangible assets, to the Consolidated Financial Statements. Other operating expenses for 2024 included impairment charges associated with IPR&D intangible assets related to our Teneobio acquisition in 2021 and expenses related to cost-savings initiatives incurred in 2024.
Our accumulated deficit is not anticipated to affect our future ability to operate, repurchase stock, pay dividends or repay our debt given our expected continued profitability and strong financial position. 73 We believe that existing funds, cash generated from operations and existing sources of and access to financing are adequate to satisfy our needs for working capital, capital expenditure and debt service requirements as well as our plans to reduce debt, pay dividends and repurchase stock, and other business initiatives we plan to strategically pursue, including acquisitions and licensing activities.
We believe that existing funds, cash generated from operations and existing sources of and access to financing are adequate to satisfy our needs for working capital, capital expenditure and debt service requirements, pay dividends and repurchase stock, and other business initiatives we plan to strategically pursue, including acquisitions and licensing activities.
Repatha Total Repatha sales by geographic region were as follows (dollar amounts in millions): Year ended December 31, 2024 Change Year ended December 31, 2023 Change Year ended December 31, 2022 Repatha — U.S. $ 1,139 44 % $ 793 30 % $ 608 Repatha — ROW 1,083 29 % 842 22 % 688 Total Repatha $ 2,222 36 % $ 1,635 26 % $ 1,296 The increase in global Repatha sales for 2024 was primarily driven by volume growth of 43%, partially offset by lower net selling price of 10%.
Repatha Total Repatha sales by geographic region were as follows (dollar amounts in millions): Year ended December 31, 2025 Change Year ended December 31, 2024 Change Year ended December 31, 2023 Repatha — U.S. $ 1,663 46 % $ 1,139 44 % $ 793 Repatha — ROW 1,353 25 % 1,083 29 % 842 Total Repatha $ 3,016 36 % $ 2,222 36 % $ 1,635 The increase in global Repatha sales for 2025 was driven by volume growth.
Financial Condition, Liquidity and Capital Resources Selected financial data was as follows (in millions): December 31, 2024 2023 Cash and cash equivalents $ 11,973 $ 10,944 Total assets $ 91,839 $ 97,154 Current portion of long-term debt $ 3,550 $ 1,443 Long-term debt $ 56,549 $ 63,170 Stockholders’ equity $ 5,877 $ 6,232 Cash and cash equivalents Our balance of cash and cash equivalents was $12.0 billion on December 31, 2024.
Financial condition, liquidity and capital resources Selected financial data was as follows (in millions): December 31, 2025 2024 Cash and cash equivalents $ 9,129 $ 11,973 Total assets $ 90,586 $ 91,839 Current portion of long-term debt $ 4,599 $ 3,550 Long-term debt $ 50,005 $ 56,549 Stockholders’ equity $ 8,658 $ 5,877 Cash and cash equivalents Our balance of cash and cash equivalents was $9.1 billion as of December 31, 2025.

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Item 7A. Quantitative and Qualitative Disclosures About Market Risk

Market Risk — interest-rate, FX, commodity exposure

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Biggest changeIncreases and decreases in our foreign-currency-denominated assets from movements in foreign currency exchange rates are partially 81 offset by corresponding increases or decreases in our foreign-currency-denominated liabilities. To further reduce our net exposure to foreign currency exchange rate fluctuations on our results of operations, we enter into foreign currency forward and cross-currency swap contracts.
Biggest changeTo further reduce our net exposure to foreign currency exchange rate fluctuations on our results of operations, we enter into foreign currency forward and cross-currency swap contracts. 81 As of December 31, 2025, we had outstanding euro- and pound-sterling-denominated debt with both a principal carrying value and a fair value of $2.5 billion.
With regard to foreign currency forward contracts that were open as of December 31, 2024, a hypothetical 20% adverse movement in foreign currency exchange rates compared with the U.S. dollar relative to exchange rates as of December 31, 2024, would have resulted in a reduction in fair value of these contracts of approximately $1.3 billion on this date and in the ensuing year, a reduction in income of approximately $700 million.
With regard to contracts that were open as of December 31, 2024, a hypothetical 20% adverse movement in foreign currency exchange rates compared with the U.S. dollar relative to exchange rates as of December 31, 2024, would have resulted in a reduction in fair value of these contracts of approximately $1.3 billion on this date and in the ensuing year, a reduction in income of $700 million.
A hypothetical 20% adverse movement in foreign currency exchange rates compared with the U.S. dollar relative to exchange rates as of December 31, 2024, would have resulted in an increase in fair value of this debt of approximately $440 million on this date and a reduction in income in the ensuing year of approximately $450 million.
A hypothetical 20% adverse movement in foreign currency exchange rates compared with the U.S. dollar relative to exchange rates as of December 31, 2024, would have resulted in an increase in fair value of this debt of $440 million on this date and a reduction in income in the ensuing year of $450 million.
In addition, we have an investment policy that limits investments to certain types of debt and money market instruments issued by institutions with investment-grade credit ratings and places restriction on maturities and concentrations by asset class and issuer.
In addition, we have an investment policy that limits 82 investments to certain types of debt and money market instruments issued by institutions with investment-grade credit ratings and places restriction on maturities and concentrations by asset class and issuer.
Except as noted below, we also assumed a hypothetical 20% change in foreign currency exchange rates against the U.S. dollar based on its position relative to other currencies as of December 31, 2024 and 2023. Interest-rate-sensitive financial instruments Our portfolio of available-for-sale investments as of December 31, 2024 and 2023, was composed almost entirely of U.S.
Except as noted below, we also assumed a hypothetical 20% change in foreign currency exchange rates against the U.S. dollar based on its position relative to other currencies as of December 31, 2025 and 2024. Interest-rate-sensitive financial instruments Our portfolio of available-for-sale investments as of December 31, 2025 and 2024, was composed almost entirely of U.S.
With regard to these foreign currency forward contracts that were open as of December 31, 2024 and 2023, a hypothetical 5% adverse movement in foreign currency exchange rates compared with the U.S. dollar relative to exchange rates on these dates would not have a material effect on the fair values of these contracts or related income in the respective ensuing years.
With regard to these foreign currency forward contracts that were open as of December 31, 2025 and 2024, a hypothetical 5% adverse movement in foreign currency exchange rates compared with the U.S. dollar relative to exchange rates on these dates would not have a material effect on the fair values of these contracts or related income in the respective ensuing years.
These interest rate swap contracts effectively converted a fixed-rate interest coupon to a floating-rate SOFR-based coupon over the terms of the respective notes. Interest rate swap contracts with an aggregate notional amount of $6.7 billion were outstanding as of both December 31, 2024 and 2023.
These interest rate swap contracts effectively converted a fixed-rate interest coupon to a floating-rate SOFR-based coupon over the terms of the respective notes. Interest rate swap contracts with an aggregate notional amount of $6.7 billion were outstanding as of both December 31, 2025 and 2024.
A hypothetical 20% adverse movement in foreign currency exchange rates compared with the U.S. dollar relative to exchange rates on these dates would have resulted in reductions in the fair values of these contracts of approximately $450 million and $480 million on these dates, respectively.
A hypothetical 20% adverse movement in foreign currency exchange rates compared with the U.S. dollar relative to exchange rates on these dates would have resulted in reductions in the fair values of these contracts of approximately $500 million and $450 million on these dates, respectively.
Market-price-sensitive financial instruments As of December 31, 2024 and 2023, we were exposed to price risk on equity securities included in our portfolio of investments, which were acquired primarily for the promotion of business and strategic objectives.
Market-price-sensitive financial instruments As of December 31, 2025 and 2024, we were exposed to price risk on equity securities included in our portfolio of investments, which were acquired primarily for the promotion of business and strategic objectives.
Applying a duration model, a hypothetical 100 basis point increase in interest rates as of December 31, 2024 and 2023, would not have resulted in a material reduction in the fair values of these securities.
Applying a duration model, a hypothetical 100 basis point increase in interest rates as of December 31, 2025 and 2024, would not have resulted in a material reduction in the fair values of these securities.
Changes in interest rates would, however, affect the fair values of fixed-rate debt. A hypothetical 100 basis point decrease in interest rates relative to interest rates as of December 31, 2024 and 2023, would have resulted in increases of $4.7 billion and $5.4 billion, respectively, in the aggregate fair values of our outstanding debt on these dates.
Changes in interest rates would, however, affect the fair values of fixed-rate debt. A hypothetical 100 basis point decrease in interest rates relative to interest rates as of December 31, 2025 and 2024, would have resulted in increases of $4.4 billion and $4.7 billion, respectively, in the aggregate fair values of our outstanding debt on these dates.
In the discussion that follows, we assumed a hypothetical change in interest rates of 100 basis points from those as of December 31, 2024 and 2023.
In the discussion that follows, we assumed a hypothetical change in interest rates of 100 basis points from those as of December 31, 2025 and 2024.
As of December 31, 2024, we had outstanding euro- and pound-sterling-denominated debt with both a principal carrying value and a fair value of $2.2 billion. As of December 31, 2023, we had outstanding euro- and pound-sterling-denominated debt with both a principal carrying value and a fair value of $2.3 billion.
As of December 31, 2024, we had outstanding euro- and pound-sterling-denominated debt with both a principal carrying value and a fair value of $2.2 billion.
Treasury securities and money market mutual funds. The fair values of our available-for-sale investments were $11.5 billion and $10.4 billion as of December 31, 2024 and 2023, respectively. Duration is a sensitivity measure that can be used to approximate the change in the value of a security that will result from a 100 basis point change in interest rates.
Treasury securities and money market mutual funds. The fair values of our available-for-sale investments were $8.5 billion and $11.5 billion as of December 31, 2025 and 2024, respectively. Duration is a sensitivity measure that can be used to approximate the change in the value of a security that will result from a 100 basis point change in interest rates.
A hypothetical 100 basis point increase in interest rates relative to interest rates as of December 31, 2024 and 2023, would have resulted in reductions in fair values of approximately $220 million and $180 million, respectively, on our interest rate swap contracts on these dates.
A hypothetical 100 basis point increase in interest rates relative to interest rates as of December 31, 2025 and 2024, would have resulted in reductions in fair values of approximately $240 million and $220 million, respectively, on our interest rate swap contracts on these dates.
These contracts had no material net unrealized gains or losses as of December 31, 2024 and 2023.
These contracts had no material net unrealized gains or losses as of December 31, 2025 and 2024.
A hypothetical 20% adverse movement in foreign currency exchange rates compared with the U.S. dollar relative to exchange rates as of December 31, 2023, would have resulted in an increase in fair value of this debt of $460 million on this date and a reduction in income in the ensuing year of $470 million.
A hypothetical 20% adverse movement in foreign currency exchange rates compared with the U.S. dollar relative to exchange rates as of December 31, 2025, would have resulted in an increase in fair value of this debt of approximately $490 million on this date and a reduction in income in the ensuing year of approximately $490 million.
With regard to contracts that were open as of December 31, 2023, a hypothetical 20% adverse movement in foreign currency exchange rates compared with the U.S. dollar relative to exchange rates as of December 31, 2023, would have resulted in a reduction in fair value of these contracts of approximately $1.2 billion on this date and in the ensuing year, a reduction in income of $690 million.
With regard to foreign currency forward contracts that were open as of December 31, 2025, a hypothetical 20% adverse movement in foreign currency exchange rates compared with the U.S. dollar relative to exchange rates as of December 31, 2025, would have resulted in a reduction in fair value of these contracts of approximately $1.5 billion on this date and in the ensuing year, a reduction in income of approximately $800 million.
We have cross-currency swap contracts that are designated as cash flow hedges of our debt denominated in euros and pounds sterling with aggregate notional amounts of $2.7 billion as of both December 31, 2024 and 2023.
We have cross-currency swap contracts that are designated as cash flow hedges of our debt denominated in euros and pounds sterling with an aggregate notional amount of $2.7 billion as of both December 31, 2025 and 2024.
As of December 31, 2024, we had primarily euro-based open foreign currency forward contracts with an aggregate notional amount of $7.2 billion. As of December 31, 2023, we had primarily euro-based open foreign currency forward contracts with an aggregate notional amount of $6.6 billion.
As of December 31, 2025, we had primarily euro-based open foreign currency forward contracts with an aggregate notional amount of $7.8 billion. As of December 31, 2024, we had primarily euro-based open foreign currency forward contracts with an aggregate notional amount of $7.2 billion.
The sensitivity analysis of the notes does not consider the impact that hypothetical changes in interest rates would have on related interest rate swap contracts and cross-currency swap contracts, discussed below. In addition, the analysis above does not include our term loans, which had carrying values of $1.8 billion and $4.0 billion at December 31, 2024 and 2023, respectively.
The sensitivity analysis of the notes does not consider the impact that hypothetical changes in interest rates would have on related interest rate swap contracts and cross-currency swap contracts, discussed below. In addition, the analysis above does not include our term loans, which had a carrying value of $1.8 billion at both December 31, 2025 and 2024.
As of December 31, 2024 and 2023, we had open, short-duration, foreign currency forward contracts that mature in one month or less, that had aggregate notional amounts of $0.1 billion and $0.5 billion, respectively, and that hedged fluctuations of certain assets and liabilities denominated in foreign currencies but were not designated as hedges for accounting purposes.
As of December 31, 2025 and 2024, we had open, short-duration, foreign currency forward contracts that mature in one month or less, that had aggregate notional amounts of $240 million and $148 million, respectively, and that hedged fluctuations of certain assets and liabilities denominated in foreign currencies but were not designated as hedges for accounting purposes.
In addition, a hypothetical 100 basis point decrease in interest rates as of December 31, 2024 and 2023, would not result in a material effect on income in the respective ensuing year. As of December 31, 2024, we had outstanding notes with an aggregate carrying value of $58.3 billion and an aggregate fair value of $54.9 billion.
In addition, a hypothetical 100 basis point decrease in interest rates as of December 31, 2025 and 2024, would not result in a material effect on income in the respective ensuing year. As of December 31, 2025, we had outstanding notes with an aggregate carrying value of $52.8 billion and an aggregate fair value of $51.0 billion.
As of December 31, 2024, the fair values of these contracts were a $420 million asset and an $8 million liability. As of December 31, 2023, the fair values of these contracts were a $145 million asset and a $116 million liability.
As of December 31, 2025, the fair values of these contracts were a $195 million asset and a $213 million liability. As of December 31, 2024, the fair values of these contracts were a $420 million asset and an $8 million liability.
As of December 31, 2023, we had outstanding notes with an aggregate carrying value of $60.6 billion and an aggregate fair value of $59.2 billion. Our outstanding notes were composed of debt with fixed interest rates. Changes in interest rates do not affect interest expense on fixed-rate debt.
As of December 31, 2024, we had outstanding notes with an aggregate carrying value of $58.3 billion and an aggregate fair value of $54.9 billion. Our outstanding notes were composed of debt with fixed interest rates. Changes in interest rates do not affect interest expense on fixed-rate debt.
The fair values of our term loans approximate their carrying values as these debt instruments bear interest at floating rates. To achieve a desired mix of fixed-rate and floating-rate debt, we entered into interest rate swap contracts that qualified and were designated for accounting purposes as fair value hedges for certain of our fixed-rate debt.
The fair value of our term loan is approximated at its carrying value as this debt instrument bears interest at a floating rate. To achieve a desired mix of fixed-rate and floating-rate debt, we entered into interest rate swap contracts that qualified and were designated for accounting purposes as fair value hedges for certain of our fixed-rate debt.
As of both December 31, 2024 and 2023, we had outstanding cross-currency swap contracts with aggregate notional amounts of $2.7 billion that hedge our foreign-currency-denominated debt and related interest payments. These contracts effectively convert interest payments and principal repayment of this debt to U.S. dollars from euros and pounds sterling and are designated for accounting purposes as cash flow hedges.
These contracts effectively convert interest payments and principal repayment of this debt to U.S. dollars from euros and pounds sterling and are designated for accounting purposes as cash flow hedges.
Foreign-currency-sensitive financial instruments Our international operations are affected by fluctuations in the value of the U.S. dollar compared with foreign currencies, predominantly the euro. Increases and decreases in our international product sales from movements in foreign currency exchange rates are partially offset by corresponding increases or decreases in our international operating expenses.
Increases and decreases in our international product sales from movements in foreign currency exchange rates are partially offset by corresponding increases or decreases in our international operating expenses. Increases and decreases in our foreign-currency-denominated assets from movements in foreign currency exchange rates are partially offset by corresponding increases or decreases in our foreign-currency-denominated liabilities.
A 20% decrease in the aggregate value of our equity investment portfolio as of December 31, 2024 and 2023, would result in losses in fair value of approximately $950 million and $1.0 billion, respectively. 82 Counterparty credit risks Our financial instruments, including derivatives, are subject to counterparty credit risk, which we consider as part of the overall fair value measurement.
Counterparty credit risks Our financial instruments, including derivatives, are subject to counterparty credit risk, which we consider as part of the overall fair value measurement.
A hypothetical 100 basis point adverse movement in interest rates relative to interest rates as of December 31, 2024 and 2023, would have resulted in reductions in the fair values of our cross-currency swap contracts of approximately $70 million and $100 million, respectively.
A hypothetical 100 basis point adverse movement in interest rates relative to interest rates as of December 31, 2025 and 2024, would not have a material effect on the fair values of our cross-currency swap contracts. Foreign-currency-sensitive financial instruments Our international operations are affected by fluctuations in the value of the U.S. dollar compared with foreign currencies, predominantly the euro.
These investments include our investments in BeiGene and Neumora, as well as other publicly and privately held small-capitalization stocks and limited partnerships that invest in early-stage biotechnology companies.
These investments include our investment in BeOne, as well as other publicly and privately held small-capitalization stocks and limited partnerships that invest in early-stage biotechnology companies. A 20% decrease in the aggregate value of our equity investment portfolio as of December 31, 2025 and 2024, would result in losses in fair value of approximately $1.4 billion and $950 million, respectively.
Added
As of both December 31, 2025 and 2024, we had outstanding cross-currency swap contracts with an aggregate notional amount of $2.7 billion that hedge our foreign-currency-denominated debt and related interest payments.

Other AMGN 10-K year-over-year comparisons