Amgen (AMGN) risk factors, FY2024 10-K

RISKS RELATED TO GOVERNMENT REGULATIONS AND THIRD-PARTY POLICIES

1. 01Our 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
2. 02Ultimately, 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
3. 03Guidelines and recommendations published by various organizations can reduce the use of our products
4. 04See 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
5. 05Our business may be affected by litigation and government investigations

RISKS RELATED TO ECONOMIC CONDITIONS AND OPERATING A GLOBAL BUSINESS

1. 06Our 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
2. 07We 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)
3. 08Our sales and operations are subject to the risks of doing business internationally, including in emerging markets
4. 09We may not be able to access the capital and credit markets on terms that are favorable to us, or at all

RISKS RELATED TO COMPETITION

1. 10Our products face substantial competition and our product candidates are also likely to face substantial competition
2. 11Our intellectual property positions may be challenged, invalidated or circumvented, or we may fail to prevail in current and future intellectual property litigation
3. 12and 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
4. 13We currently face competition from biosimilars and generics and expect to face increasing competition from biosimilars and generics in the future
5. 14Concentration 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

1. 15We may not be able to develop commercial products despite significant investments in R&D
2. 16We must conduct clinical trials in humans before we commercialize and sell any of our product candidates or existing products for new indications
3. 17Our current products and products in development cannot be sold without regulatory approval
4. 18Regulatory 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
5. 19Some of our products are used with drug delivery or companion diagnostic devices that have their own regulatory, manufacturing and other risks
6. 20Some 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

1. 21We rely on third-party suppliers for certain of our raw materials, medical devices and components
2. 22Manufacturing difficulties, disruptions or delays could limit supply of our products and limit our product sales
3. 23therapeutics instead of our products, which could have a material adverse effect on our product sales, business and results of operations
4. 24Our business and operations may be negatively affected by the failure, or perceived failure, of achieving our environmental, social and governance objectives
5. 25The effects of global climate change and related natural disasters could negatively affect our business and operations
6. 26Global economic conditions may negatively affect us and may magnify certain risks that affect our business
7. 27Our stock price is volatile