What the changes say
- Keytruda sales concentration rose to 49% of total revenue.
- Gardasil faces severely lower demand in China.
- Bridion faces U.S. patent expiry in July 2026.
- AI governance risks now cite the EU AI Act and NIS2 Directive.
What changed since the prior 10-K
New
- NewRisks Related to the Company’s Business
certain foreign markets relating to patents, as well as regulatory initiatives may result in a more general weakening of intellectual property protection
Foreign regulatory initiatives and patent losses may weaken intellectual property protection and cause significant sales declines for key products.
Reworded
- 69% rewrittenRisks Related to the Company’s Business
As the Company’s products lose market exclusivity, the Company generally experiences a significant and rapid loss of sales from those products
Added that Bridion will lose U.S. market exclusivity in July 2026, leading to a planned U.S. sales discontinuation by the end of 2026, alongside Januvia and Janumet.
- 45% rewrittenRisks Related to the Company’s Business
The Company may experience difficulties and delays in manufacturing certain of its products, including vaccines
Removed specific references to Varivax and ProQuad manufacturing delays and 2025 supply constraints while adding raw material shortages and site change limits.
- 43% rewrittenRisks Related to the Company’s Business
Key products generate a significant amount of the Company’s profits and cash flows, and any events that adversely affect the markets for its leading products could have a material adverse effect on the Company’s results of operations, cash flows, financial condition, and prospects
Updated key product drivers to include Winrevair, noted Keytruda reached 49% of 2025 sales, and described China Gardasil demand as materially lower.
Was: Key products generate a significant amount of the Company’s profits and cash flows, and any events that adversely affect the markets for its leading products could have a material adverse effect on the Company’s results of operations and financial condition
- 40% rewrittenRisks Related to the Company’s Business
The Company faces continued pricing pressure with respect to its products in the public and private sectors
Retained pricing pressure disclosures from mature markets, managed care organizations, and U.S. legislation including Medicare, Medicaid, the ACA, and the IRA.
Was: The Company faces continued pricing pressure with respect to its products
- 38% rewrittenRisks Related to Technology
The Company is increasing its use of artificial intelligence (AI) systems to automate processes, analyze data, and support decision-making, which poses inherent risks
Added specific references to the European Union AI Act, NIS2 Directive, and risks of employee use of open-source or generative AI tools.
- 36% rewrittenRisks Related to the Company’s Business
The Company has significant global operations, which expose it to additional risks, and any adverse event could have a material adverse effect on the Company’s results of operations, cash flows, financial condition, and prospects
Added the explicit risk of tariff imposition by the U.S. or other governments to global operations.
Was: The Company has significant global operations, which expose it to additional risks, and any adverse event could have a material adverse effect on the Company’s results of operations and financial condition
- 34% rewrittenRisks Related to the Company’s Business
Climate change or legal, regulatory or market measures to address climate change may negatively affect the Company’s business, results of operations, cash flows, financial condition, and prospects
Retained physical, transitional, and social risks associated with climate change and extreme weather events without major textual alteration.
Was: Climate change or legal, regulatory or market measures to address climate change may negatively affect the Company’s business, results of operations, cash flows and prospects
- 33% rewrittenRisks Relating to Government Regulation and Legal Proceedings
The health care industry in the U.S. has been, and will continue to be, subject to increasing regulation and political action
Updated verb tense regarding the 2022 passage of the IRA and the 2025 implementation of the Medicare Part D redesign.
- 33% rewrittenRisks Related to the Company’s Business
The Company is dependent on its patent rights, and if its patent rights are invalidated or circumvented, its business could be materially adversely affected
All 30 risk factors
Headings as the filing states them, in filing order.
Risks Related to the Company’s Business
- 01The Company is dependent on its patent rights, and if its patent rights are invalidated or circumvented, its business could be materially adversely affected33% rewritten
- 02certain foreign markets relating to patents, as well as regulatory initiatives may result in a more general weakening of intellectual property protectionNew
- 03As the Company’s products lose market exclusivity, the Company generally experiences a significant and rapid loss of sales from those products69% rewritten
- 04Key products generate a significant amount of the Company’s profits and cash flows, and any events that adversely affect the markets for its leading products could have a material adverse effect on the Company’s results of operations, cash flows, financial condition, and prospects43% rewritten
- 05The Company’s research and development efforts may not succeed in developing commercially successful products and the Company may not be able to acquire commercially successful products in other ways; consequently, the Company may not be able to replace sales of successful products that lose patent protection
- 06The Company’s success is dependent on the successful development and marketing of new products, which are subject to substantial risks
- 07The Company faces continued pricing pressure with respect to its products in the public and private sectors40% rewritten
- 08Unfavorable or uncertain economic conditions, together with cost-reduction measures being taken by the U.S. and other countries, could negatively affect the Company’s operating results
- 09The Company faces intense competition from both lower cost generic and biosimilar products and competitors’ products
- 10The Company has significant global operations, which expose it to additional risks, and any adverse event could have a material adverse effect on the Company’s results of operations, cash flows, financial condition, and prospects36% rewritten
- 11Climate change or legal, regulatory or market measures to address climate change may negatively affect the Company’s business, results of operations, cash flows, financial condition, and prospects34% rewritten
- 12Environmental, social and governance matters may impact the Company’s business and reputation
- 13Failure to attract and retain highly qualified personnel could affect the Company’s ability to successfully develop and commercialize products
- 14The Company may experience difficulties and delays in manufacturing certain of its products, including vaccines45% rewritten
- 15The Company may not be able to realize the expected benefits of its investments in emerging markets
- 16The Company is exposed to market risk from fluctuations in currency exchange rates and interest rates
- 17Pharmaceutical products can develop unexpected safety or efficacy concerns
- 18Reliance on third-party relationships and outsourcing arrangements could materially adversely affect the Company’s business
- 19Negative events in the animal health industry could have a material adverse effect on future results of operations and financial condition of the Company or its Animal Health business
- 20Biologics and vaccines carry unique risks and uncertainties, which could have a material adverse effect on the Company’s future results of operations, cash flows, financial condition, and prospects
Risks Relating to Government Regulation and Legal Proceedings
- 21The health care industry in the U.S. has been, and will continue to be, subject to increasing regulation and political action33% rewritten
- 22The Company’s products, including products in development, cannot be marketed unless the Company obtains and maintains regulatory approval or authorization
- 23Developments following regulatory approval or authorization may adversely affect sales of the Company’s products
- 24The Company is subject to a variety of U.S. and international laws and regulations
- 25The Company is subject to evolving and complex tax laws, which may result in additional liabilities that may affect results of operations and financial condition
- 26Adverse outcomes in current or future legal matters could negatively affect the Company’s business
- 27Product liability insurance for products may be limited, cost prohibitive or unavailable
Risks Related to Technology
- 28The Company is increasing its use of artificial intelligence (AI) systems to automate processes, analyze data, and support decision-making, which poses inherent risks38% rewritten
- 29Social media and mobile messaging platforms present risks and challenges
- 30(Cautionary Statements Under the Private Securities Litigation Reform Act of 1995)
Other Merck 10-Ks
- FY2024 10-K risk factors29 risks
Merck depends heavily on patent exclusivity and its oncology portfolio, led by Keytruda, for revenue growth.
Filed Feb 25, 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.