AbbVie (ABBV) risk factors, FY2025 10-K

Risks Related to AbbVie's Business

1. 01The expiration or loss of patent protection and licenses, including the loss of exclusivity for any of our products and increased competition from generics and biosimilars, may adversely affect AbbVie's revenues and operating earnings32% rewritten
2. 02A significant portion of AbbVie's revenues and operating earnings are derived from two major products. Specifically, Skyrizi and Rinvoq each represented greater than 10% of AbbVie's total net revenues and, in aggregate, these products accounted for approximately 42% of total net revenues in 2025New
3. 03AbbVie's major products could lose patent protection earlier than expected, which could adversely affect AbbVie's revenues and operating earnings
4. 04A third party's intellectual property may prevent AbbVie from selling its products or have a material adverse effect on AbbVie's profitability and financial condition
5. 05AbbVie's research and development efforts may not succeed in developing products and technologies that can be successfully commercialized, which may cause its revenues and profitability to decline
6. 06AbbVie is subject to cost-containment efforts and pricing pressures that could cause a reduction in revenues and operating earnings, and changes in the terms of rebate and chargeback programs, which are common in the pharmaceuticals industry, could have a material adverse effect on AbbVie's operations46% rewritten
7. 07Pharmacy benefit managers and other supply chain intermediaries exert significant influence over pricing and patient access to our products, which could adversely affect our revenues and results of operationsNew
8. 08A portion of AbbVie's near-term pharmaceutical pipeline relies on collaborations with third parties, which may adversely affect the development and sale of its products
9. 09Biologics carry unique risks and uncertainties, which could have a negative impact on AbbVie's business and results of operations
10. 10Trade restrictions, tariffs, and other changes in global trade policy could increase costs, disrupt supply chains, and adversely affect AbbVie’s business and results of operationsNew
11. 11New products and technological advances by AbbVie's competitors may negatively affect AbbVie's results of operations
12. 12The manufacture of many of AbbVie's products is a highly exacting and complex process requiring critical environmental controls, and if AbbVie or one of its suppliers encounters problems manufacturing AbbVie's products, AbbVie's business could suffer
13. 13AbbVie uses raw materials and components in its pharmaceutical and biologic manufacturing processes, including those sourced from single suppliers around the world, and an interruption in the supply of those raw materials and components could adversely affect AbbVie's business and results of operations
14. 14Certain aspects of AbbVie’s operations are highly dependent upon third party service providers
15. 15Significant safety or efficacy issues could arise for AbbVie's products, which could have a material adverse effect on AbbVie's revenues and financial condition
16. 16AbbVie is subject to product liability claims and other lawsuits that may adversely affect its business, results of operations and reputation
17. 17AbbVie is subject to governmental regulations, and it can be costly to comply with these regulations and to develop compliant products and processes
18. 18Laws and regulations affecting government benefit programs could impose new obligations on AbbVie, require it to change its business practices, and restrict its operations26% rewritten
19. 19The international nature of AbbVie's business subjects it to additional business risks that may cause its revenue and profitability to decline
20. 20If AbbVie does not effectively and profitably commercialize its products, AbbVie's revenues and financial condition could be adversely affected
21. 21AbbVie may acquire other businesses, license rights to technologies or products, form alliances, or dispose of assets, which could cause it to incur significant expenses and could negatively affect profitability
22. 22AbbVie is dependent on wholesale distributors for distribution of its products in the United States and, accordingly, its business and results of operations could be adversely affected if they encounter financial or other difficulties
23. 23AbbVie has debt obligations that could adversely affect its business and its ability to meet its obligations
24. 24AbbVie may need additional financing in the future to meet its capital needs or to make opportunistic acquisitions, and such financing may not be available on favorable terms, if at all
25. 25AbbVie depends on information technology and a failure of, or significant disruption to, those systems, or a failure to adequately adopt emerging technologies such as artificial intelligence, could have a material adverse effect on AbbVie's business44% rewritten
26. 26A significant amount of AbbVie’s total assets is related to acquired intangibles and goodwill. As of December 31, 2025, the carrying value of AbbVie’s developed product rights and other intangible assets was $52.6 billion and the carrying value of AbbVie’s goodwill was $35.6 billion
27. 27Failure to attract, develop and retain highly qualified personnel could affect AbbVie’s ability to successfully develop and commercialize products
28. 28The illegal distribution and sale by third parties of counterfeit or unregistered versions of AbbVie products could have a material adverse impact on its reputation, business and results of operations
29. 29Other factors can have a material adverse effect on AbbVie's profitability and financial condition

Risks Related to AbbVie's Common Stock

1. 30AbbVie cannot guarantee the timing, amount, or payment of dividends on its common stock or the repurchase of its common stock
2. 31An AbbVie stockholder's percentage of ownership in AbbVie may be diluted in the future
3. 32Certain provisions in AbbVie's amended and restated certificate of incorporation and amended and restated by-laws, and of Delaware law, may prevent or delay an acquisition of AbbVie, which could decrease the trading price of AbbVie's common stock
4. 33CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS