Merck (MRK) risk factors, FY2024 10-K

Risks Related to the Company’s Business

1. 01The Company is dependent on its patent rights, and if its patent rights are invalidated or circumvented, its business could be materially adversely affected
2. 02As the Company’s products lose market exclusivity, the Company generally experiences a significant and rapid loss of sales from those products
3. 03Key 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
4. 04The 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. 05The Company’s success is dependent on the successful development and marketing of new products, which are subject to substantial risks
6. 06The Company faces continued pricing pressure with respect to its products
7. 07Unfavorable or uncertain economic conditions, together with cost-reduction measures being taken by certain governments, could negatively affect the Company’s operating results
8. 08The Company faces intense competition from both lower cost generic and biosimilar products and competitors’ products
9. 09The 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
10. 10Climate 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
11. 11Environmental, social and governance matters may impact the Company’s business and reputation
12. 12Failure to attract and retain highly qualified personnel could affect the Company’s ability to successfully develop and commercialize products
13. 13The Company may experience difficulties and delays in manufacturing certain of its products, including vaccines
14. 14The Company may not be able to realize the expected benefits of its investments in emerging markets
15. 15The Company is exposed to market risk from fluctuations in currency exchange rates and interest rates
16. 16Pharmaceutical products can develop unexpected safety or efficacy concerns
17. 17Reliance on third-party relationships and outsourcing arrangements could materially adversely affect the Company’s business
18. 18Negative 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
19. 19Biologics and vaccines carry unique risks and uncertainties, which could have a material adverse effect on the Company’s future results of operations and financial condition

Risks Relating to Government Regulation and Legal Proceedings

1. 20The health care industry in the U.S. has been, and will continue to be, subject to increasing regulation and political action
2. 21The Company’s products, including products in development, cannot be marketed unless the Company obtains and maintains regulatory approval
3. 22Developments following regulatory approval may adversely affect sales of the Company’s products
4. 23The Company is subject to a variety of U.S. and international laws and regulations
5. 24The 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. 25Adverse outcomes in current or future legal matters could negatively affect Merck’s business
7. 26Product liability insurance for products may be limited, cost prohibitive or unavailable

Risks Related to Technology

1. 27The Company is increasing its use of artificial intelligence (AI) systems to automate processes, analyze data, and support decision-making which poses inherent risks
2. 28Social media and mobile messaging platforms present risks and challenges
3. 29(Cautionary Statements Under the Private Securities Litigation Reform Act of 1995)