Merck & Co. (MRK) risk factors: FY2025 10-K

1. The Company is dependent on its patent rights, and if its patent rights are invalidated or circumvented, its business could be materially adversely affected.
2. As the Company’s products lose market exclusivity, the Company generally experiences a significant and rapid loss of sales from those products.
3. 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.reworded
4. The 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.
5. The Company’s success is dependent on the successful development and marketing of new products, which are subject to substantial risks.
6. The Company faces continued pricing pressure with respect to its products in the public and private sectors.reworded
7. Unfavorable 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.reworded
8. The Company faces intense competition from both lower cost generic and biosimilar products and competitors’ products.
9. 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.reworded
10. 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.reworded
11. Environmental, social and governance matters may impact the Company’s business and reputation.
12. Failure to attract and retain highly qualified personnel could affect the Company’s ability to successfully develop and commercialize products.
13. The Company may experience difficulties and delays in manufacturing certain of its products, including vaccines.
14. The Company’s business in China experienced significantly lower sales of Gardasil/Gardasil 9 in 2025 and the Company expects that sales of Gardasil/Gardasil 9 in China will not materially increase in 2026. As a consequence of the reduced sales of Gardasil/Gardasil 9, the Company’s business in China declined significantly.newChina
15. The Company may not be able to realize the expected benefits of its investments in emerging markets.
16. The Company is exposed to market risk from fluctuations in currency exchange rates and interest rates.Interest rates
17. Pharmaceutical products can develop unexpected safety or efficacy concerns.
18. Reliance on third-party relationships and outsourcing arrangements could materially adversely affect the Company’s business.
19. Negative 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.
20. Biologics 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.reworded

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1. The health care industry in the U.S. has been, and will continue to be, subject to increasing regulation and political action.
2. The Company’s products, including products in development, cannot be marketed unless the Company obtains and maintains regulatory approval or authorization.reworded
3. Developments following regulatory approval or authorization may adversely affect sales of the Company’s products.reworded
4. The Company is subject to a variety of U.S. and international laws and regulations.
5. The Company is subject to evolving and complex tax laws, which may result in additional liabilities that may affect results of operations and financial condition.
6. Adverse outcomes in current or future legal matters could negatively affect the Company’s business.reworded
7. Product liability insurance for products may be limited, cost prohibitive or unavailable.

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1. The Company is increasingly dependent on sophisticated software applications and computing infrastructure, including the use of cloud-based applications and environments. The Company continues to be a target of cyber-attacks that could lead to a disruption of its worldwide operations, including manufacturing, research and sales operations.Cybersecurity
2. The Company is increasing its use of artificial intelligence (AI) systems to automate processes, analyze data, and support decision-making, which poses inherent risks.AI
3. Social media and mobile messaging platforms present risks and challenges.
4. Cautionary Factors that May Affect Future Results

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Headings in the FY2024 10-K with no match this year.

1. The Company’s business in China has grown in the past few years, and the importance of China to the Company’s overall pharmaceutical and vaccines business has increased accordingly. In 2024, the Company experienced lower sales of Gardasil/Gardasil 9 in China and expects that sales of Gardasil/Gardasil 9 in China will decline significantly in 2025.