Organon (OGN) risk factors, FY2024 10-K

Risks Related to Our Business

1. 01Key products generate a significant amount of our profits and cash flows, and any events that adversely affect the markets for our leading products could adversely affect our results of operations and financial condition
2. 02Changes to the health care system due to health care reform in the United States, as well as increased purchasing power of entities that negotiate on behalf of Medicare, Medicaid, and private sector beneficiaries, could result in further pricing pressures
3. 03We face intense competition from competitors’ products
4. 04Our growth could be limited by the scope of our intellectual property licenses for certain women’s health care products
5. 05We rely on third parties for activities related to preclinical and clinical testing
6. 06We may experience difficulties identifying future acquisition opportunities or completing such transactions. Even if we complete such transactions, we may have difficulty integrating or otherwise realizing the benefits of such acquisitions
7. 07We may be unable to market our pharmaceutical products or medical devices if we do not obtain and maintain required regulatory approvals or marketing authorizations
8. 08Developments following regulatory approval or marketing authorization may adversely affect sales of our pharmaceutical products or medical devices
9. 09Issues with product quality could have an adverse effect on our business or cause a loss of customer confidence in us or our products, among other negative consequences
10. 10Patent protections are important to the marketing and sale of certain of our products, particularly certain of our women’s health products, as such protection provides market exclusivity
11. 11Additionally, court decisions relating to other companies’ patents, potential legislation in both the United States and certain other markets relating to patents, as well as regulatory initiatives, may result in a more general weakening of intellectual property protection
12. 12We have incurred substantial indebtedness, which could adversely affect our financial condition and results of operations
13. 13We are subject to minimum purchase obligations under certain supply agreements, and if we fail to meet those minimum purchase requirements, our financial results may be unfavorably impacted
14. 14The health care industry in the United States has been, and will continue to be, subject to judicial decisions and increasing laws, regulation, executive orders and political action
15. 15We are subject to a variety of laws and regulations, and we may face serious consequences for violations if we fail to meet the applicable legal and regulatory requirements
16. 16We have significant global operations, which expose us to additional risks, and any adverse event could adversely affect our results of operations and financial condition
17. 17The legislative and regulatory landscape for privacy, data protection and artificial intelligence (“AI”) continues to evolve
18. 18We depend on sophisticated software applications and computing infrastructure. Cyberattacks affecting our IT systems could result in exposure of confidential information, the modification of critical data or the disruption of our worldwide operations, including manufacturing and sales operations
19. 19We may experience difficulties or delays or incur unforeseen expenses in connection with the manufacturing certain of our products
20. 20We may be unable to obtain sufficient components or raw materials on a timely basis or for a cost-effective price, or we may experience other supply difficulties that could adversely affect both our ability to deliver our products and our results of operations and financial condition
21. 21We may not realize benefits from our investments in China and emerging markets
22. 22Adverse developments in the global economy or in one or more of our local markets could impact our ability to grow our business
23. 23Our reputation and promising pipeline render our products prime targets for counterfeiters
24. 24Inflation could materially adversely affect our business and operations
25. 25We are exposed to market risk from fluctuations in currency exchange rates and interest rates
26. 26Reliance on third-party relationships and outsourcing arrangements could materially adversely affect our business
27. 27The markets for our products, including the women’s health market, may not develop as expected
28. 28Our business and operations are subject to risks related to climate change and natural disasters
29. 29Our business could be negatively impacted by corporate citizenship and sustainability matters
30. 30Biosimilars carry unique regulatory risks and uncertainties, which could adversely affect our results of operations and financial condition
31. 31We rely on our collaboration with Samsung Bioepis and Henlius for the successful development and manufacture of our biosimilars products and expect to do so for the foreseeable future
32. 32We are subject to a number of restrictive covenants under our indebtedness, including customary operating restrictions and financial covenants, which could restrict our ability to pay dividends or adversely affect our financing options and liquidity position
33. 33Changes in tax laws or other tax guidance could adversely affect our effective tax rates, financial condition and results of operations
34. 34Social media and mobile messaging platforms present risks and challenges
35. 35Our corporate restructuring and the associated headcount reduction may not result in anticipated savings, could result in total costs and expenses that are greater than expected and could disrupt our business

Risks Related to Our Common Stock

1. 36The price and trading volume of our Common Stock may be volatile, and stockholders could lose all or part of their investment in us
2. 37We cannot guarantee the timing, amount or payment of any dividends on our Common Stock
3. 38Certain provisions in our amended and restated certificate of incorporation and bylaws, and of Delaware law, may prevent or delay an acquisition of us, which could decrease the trading price of our Common Stock