Amgen (AMGN) FY2025 10-K Risk Factors: 15 New, 2 Dropped

What the changes say

Amgen details extensive regulatory oversight and clinical trial processes across global markets.
State-level price control laws and PBM consolidation create severe pricing pressure.
R&D spending rose to $7.3 billion in 2025 to support 23 Phase 3 programs.

What changed since the prior 10-K

New

New
Regulation in the United States
Our research, clinical testing, manufacturing, and commercial distribution of products are heavily regulated by the FDA under the Public Health Service Act and the FDCA.
New
After laboratory analysis and preclinical testing in animals, we file an IND with the FDA to begin human testing. Typically, we undertake an FDA-designated three-phase human clinical testing program
The FDA monitors our three-phase human clinical testing programs under an IND and can reevaluate, alter, suspend, or terminate trials at its discretion.
New
In EU countries as well as in the United Kingdom, Switzerland, Canada, Australia and Japan, regulatory requirements and approval processes are similar in principle to those in the United States
Seeking marketing approval in EU countries, the UK, Switzerland, Canada, Australia, and Japan requires navigating complex decentralized or centralized regulatory procedures.
New
Research and Development and Selected Product Candidates
We focus our R&D on novel human therapeutics using human genetics and protein engineering, maintaining major research centers in Thousand Oaks, San Francisco, Iceland, and the UK.
New
For the years ended December 31, 2025, 2024 and 2023, our R&D expenses were $7.3 billion, $6.0 billion and $4.8 billion, respectively. We expect to continue allocating significant resources to our R&D activities
Our R&D expenses were $7.3 billion, $6.0 billion, and $4.8 billion for 2025, 2024, and 2023, respectively, and we face intense competition for eligible clinical trial patients.
New
(1) See Significant Developments for additional information regarding the termination of our collaboration agreement with Kyowa Kirin
Clinical trial phases test safety and efficacy across varying patient group sizes, and our collaboration agreement with Kyowa Kirin was terminated.
New
Phase 3 Product Candidate Program Changes
As of February 2026, we had 23 Phase 3 programs after six new initiations, five approvals, one stoppage, one discontinued program, and one conclusion.
New
Phase 3 Product Candidate Patent Information
We hold composition-of-matter patents for unapproved Phase 3 product candidates such as Olpasiran with a 2036 expiration and Rocatinlimab with a 2028 U.S. expiration.
New
Compensation, Benefits and Development
We design our employee compensation, base pay, and annual incentive programs to attract and retain talent in the biotechnology and pharmaceutical industries.
New
The executive officers of the Company as of February 13, 2026, are set forth below
Our executive leadership team includes CEO Robert A. Bradway and EVP of R&D Dr. James E. Bradner.
NewRISKS RELATED TO GOVERNMENT REGULATIONS AND THIRD-PARTY POLICIES
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
States are pursuing price controls and Prescription Drug Affordability Boards, with Maryland expanding its PDAB law to cover the commercial market in 2025.
NewRISKS RELATED TO GOVERNMENT REGULATIONS AND THIRD-PARTY POLICIES
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
Consolidation among health insurers and PBMs increases their negotiating leverage, resulting in greater price discounts, rebates, and service fees.
NewRISKS RELATED TO RESEARCH AND DEVELOPMENT
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
NewRISKS RELATED TO OPERATIONS
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
NewRISKS RELATED TO OPERATIONS
sustainability-related regulations across our global business, there could be a material adverse effect on our reputation, business and, ultimately, our stock price

Dropped

DroppedRISKS RELATED TO ECONOMIC CONDITIONS AND OPERATING A GLOBAL BUSINESS
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)
DroppedRISKS RELATED TO OPERATIONS
therapeutics instead of our products, which could have a material adverse effect on our product sales, business and results of operations

Reworded

100% rewrittenRISKS 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
Expanded discussion on how antitrust scrutiny and regulatory approvals for acquisitions, collaborations, and partnerships could impede execution of business strategy.
89% rewrittenRISKS RELATED TO GOVERNMENT REGULATIONS AND THIRD-PARTY POLICIES
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
Added heading specifying that existing or future state government actions or ballot initiatives may adversely affect product sales and business.
Was: 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
86% rewrittenRISKS RELATED TO OPERATIONS
Our business and operations may be negatively affected by the failure, or perceived failure, of achieving our sustainability objectives
Replaced references to ESG practices with sustainability practices and noted laws restricting non-financial factors in business decisions.
Was: Our business and operations may be negatively affected by the failure, or perceived failure, of achieving our environmental, social and governance objectives
81% rewrittenRISKS RELATED TO OPERATIONS
We rely on third-party suppliers for certain of our raw materials, medical devices and components
Updated single-source supplier examples, removing the Pushtronex automated mini doser and noting reliance on single-source SureClick autoinjectors for Repatha and ENBREL.
75% rewrittenRISKS RELATED TO GOVERNMENT REGULATIONS AND THIRD-PARTY POLICIES
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
Added that intense public scrutiny of drug prices and payer dynamics have limited our ability to set or adjust prices based on product value.
70% rewrittenRISKS RELATED TO OPERATIONS
Manufacturing difficulties, disruptions or delays could limit supply of our products and limit our product sales
Updated cross-reference regarding Horizon contract manufacturers from Part I, Item 1 to Item 1.
70% rewrittenRISKS RELATED TO OPERATIONS
Global economic conditions may negatively affect us and may magnify certain risks that affect our business
Updated macroeconomic risk factors to include geopolitical and trade policy tensions, market volatility, and government budgetary pressures.
66% rewrittenRISKS RELATED TO GOVERNMENT REGULATIONS AND THIRD-PARTY POLICIES
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
Retained tax risk disclosures regarding the 2017 Tax Act, audit challenges, and the OECD global minimum corporate tax agreement.
Was: 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
64% rewrittenRISKS RELATED TO COMPETITION
We currently face competition from biosimilars and generics and expect to face increasing competition from biosimilars and generics in the future
56% rewrittenRISKS RELATED TO ECONOMIC CONDITIONS AND OPERATING A GLOBAL BUSINESS
We may not be able to access the capital and credit markets on terms that are favorable to us, or at all
44% rewrittenRISKS RELATED TO RESEARCH AND DEVELOPMENT
Our current products and products in development cannot be sold without regulatory approval
38% rewrittenRISKS RELATED TO ECONOMIC CONDITIONS AND OPERATING A GLOBAL BUSINESS
Our sales and operations are subject to the risks of doing business internationally, including in new or emerging markets
Was: Our sales and operations are subject to the risks of doing business internationally, including in emerging markets
32% rewrittenRISKS RELATED TO GOVERNMENT REGULATIONS AND THIRD-PARTY POLICIES
Guidelines and recommendations published by various organizations can reduce the use of our products

All 40 risk factors

Headings as the filing states them, in filing order.

Other

01Regulation in the United StatesNew
02After laboratory analysis and preclinical testing in animals, we file an IND with the FDA to begin human testing. Typically, we undertake an FDA-designated three-phase human clinical testing programNew
03In EU countries as well as in the United Kingdom, Switzerland, Canada, Australia and Japan, regulatory requirements and approval processes are similar in principle to those in the United StatesNew
04Research and Development and Selected Product CandidatesNew
05For the years ended December 31, 2025, 2024 and 2023, our R&D expenses were $7.3 billion, $6.0 billion and $4.8 billion, respectively. We expect to continue allocating significant resources to our R&D activitiesNew
06(1) See Significant Developments for additional information regarding the termination of our collaboration agreement with Kyowa KirinNew
07Phase 3 Product Candidate Program ChangesNew
08Phase 3 Product Candidate Patent InformationNew
09Compensation, Benefits and DevelopmentNew
10The executive officers of the Company as of February 13, 2026, are set forth belowNew

RISKS RELATED TO GOVERNMENT REGULATIONS AND THIRD-PARTY POLICIES

11Our 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 profitability75% rewritten
12other 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 increasesNew
13Ultimately, existing or future state government actions or ballot initiatives may also have a material adverse effect on our product sales, business and results of operations89% rewritten
14manage, 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 approvedNew
15Guidelines and recommendations published by various organizations can reduce the use of our products32% rewritten
16Management’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 Statements66% rewritten
17Our business may be affected by litigation and government investigations

RISKS RELATED TO ECONOMIC CONDITIONS AND OPERATING A GLOBAL BUSINESS

18Our 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 transactions100% rewritten
19Our sales and operations are subject to the risks of doing business internationally, including in new or emerging markets38% rewritten
20We may not be able to access the capital and credit markets on terms that are favorable to us, or at all56% rewritten

RISKS RELATED TO COMPETITION

21Our products face substantial competition and our product candidates are also likely to face substantial competition
22Our intellectual property positions may be challenged, invalidated or circumvented, or we may fail to prevail in current and future intellectual property litigation
23examples of and information related to our patent litigation, see Part IV—Note 20, Contingencies and commitments, to the Consolidated Financial Statements
24We currently face competition from biosimilars and generics and expect to face increasing competition from biosimilars and generics in the future64% rewritten
25Concentration 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

RISKS RELATED TO RESEARCH AND DEVELOPMENT

26We may not be able to develop commercial products despite significant investments in R&D
27We must conduct clinical trials in humans before we commercialize and sell any of our product candidates or existing products for new indications
28Our current products and products in development cannot be sold without regulatory approval44% rewritten
29regulatory 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 labelsNew
30Regulatory authorities can also impose post-marketing pediatric study requirements. Failure to fulfill such requirements may result in regulatory or enforcement action, including financial penalties or the invalidation of a product’s marketing authorization
31Some of our products are used with drug delivery or companion diagnostic devices that have their own regulatory, manufacturing and other risks
32Some 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 OPERATIONS

33We rely on third-party suppliers for certain of our raw materials, medical devices and components81% rewritten
34materials 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 albuminNew
35Manufacturing difficulties, disruptions or delays could limit supply of our products and limit our product sales70% rewritten
36Our business and operations may be negatively affected by the failure, or perceived failure, of achieving our sustainability objectives86% rewritten
37sustainability-related regulations across our global business, there could be a material adverse effect on our reputation, business and, ultimately, our stock priceNew
38The effects of global climate change and related natural disasters could negatively affect our business and operations
39Global economic conditions may negatively affect us and may magnify certain risks that affect our business70% rewritten
40Our stock price is volatile

Other Amgen 10-Ks

FY2024 10-K risk factors
27 risks
Amgen faces heavy exposure to pricing pressure and reimbursement restrictions from government and commercial third-party payers like PBMs.
Filed Feb 14, 2025

About this page

The headings are the filing's own. The one-line readings and the overview are automated and can be wrong: read Item 1A of the 10-K for the exact wording.