Amgen (AMGN) risk factors: FY2025 10-K

1. 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.
2. —Changing U.S. federal coverage and reimbursement policies and practices have affected, and are likely to continue to affect, access to, pricing of, and sales of our products
3. —Changing reimbursement and pricing actions in various states have negatively affected, and may continue to negatively affect, access to, and have affected, and may continue to affect, sales of our products
4. —U.S. commercial payer actions have affected, and may continue to affect, access to and sales of our products
5. —Government and commercial payer actions outside the United States have affected and will continue to affect access to and sales of our products
6. Guidelines and recommendations published by various organizations can reduce the use of our products.
7. 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.new
8. Our business may be affected by litigation and government investigations.

Read these in Item 1A · See the changes

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

Read these in Item 1A · See the changes

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

Read these in Item 1A · See the changes

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

Read these in Item 1A · See the changes

1. 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.
2. We rely on third-party suppliers for certain of our raw materials, medical devices and components.
3. Manufacturing difficulties, disruptions or delays could limit supply of our products and limit our product sales.
4. Our business and operations may be negatively affected by the failure, or perceived failure, of achieving our sustainability objectives.reworded
5. The effects of global climate change and related natural disasters could negatively affect our business and operations.

Read these in Item 1A · See the changes

1. Global economic conditions may negatively affect us and may magnify certain risks that affect our business.
2. Our stock price is volatile.

Read these in Item 1A · See the changes