Viatris (VTRS) risk factors, FY2025 10-K

Other

1. 01Below is a summary of some of the more significant risks and uncertainties we face. This summary is not exhaustive and is qualified by reference to the full set of risk factors set forth in this Part I, Item 1A89% rewritten
2. 02with respect to such actions, could have a material adverse effect on our business, financial condition, results of operations, cash flows, ability to pay dividends or repurchase shares, and/or stock priceNew

Strategic Risks

1. 03We may not realize the intended benefits of, or achieve the intended goals or outlooks with respect to, our strategic initiatives and priorities, including our enterprise-wide strategic review and other potential corporate transactions60% rewritten
2. 04Viatris’ restructuring activities may not achieve their intended goals and may present significant challenges, which could have a material adverse effect on our business, financial condition, results of operations, cash flows, ability to pay dividends or repurchase shares, and/or stock priceNew
3. 05There are risks and uncertainties associated with divestitures, product rationalizations and asset sales, one or more of which could have a material adverse effect on our business, financial condition, results of operations, cash flows, ability to pay dividends or repurchase shares, and/or stock price93% rewritten
4. 06The integration of acquired businesses has presented and may in the future present significant challenges, which could have a material adverse effect on our business, financial condition, results of operations, cash flows, ability to pay dividends or repurchase shares, and/or stock priceNew
5. 07We have and may continue to experience pressure on the pricing of and reimbursements for certain of our products due to pricing controls, social or government pressure to lower the cost of drugs, and consolidation across the supply chain
6. 08additional changes in legislative or regulatory priorities and personnel may transpire at the state or federal level, or what the ultimate impact may beNew
7. 09Healthcare reform legislation could have a material adverse effect on our business34% rewritten
8. 10We have significant operations globally, which exposes us to the risks inherent in conducting our business internationally
9. 11Charges to earnings resulting from acquisitions could have a material adverse effect on our business, financial condition, results of operations, cash flows, ability to pay dividends or repurchase shares, and/or stock price
10. 12A significant portion of these adjustments could be accounted for as expenses that will decrease our net income and earnings per share for the periods in which those costs are incurred
11. 13The pharmaceutical drug supply is vulnerable to illegal counterfeiting and the presence of counterfeit or IP-infringing products in a growing number of markets, including widespread sales over the internet
12. 14We face vigorous competition that threatens the commercial acceptance and pricing of our products
13. 15A relatively small group of products may represent a significant portion of our revenues, net sales, gross profit, or net earnings from time to time36% rewritten

Operational Risks

1. 16Current and changing economic conditions, including inflation, may adversely affect our industry, business, partners and suppliers
2. 17Failure to comply with applicable environmental and occupational health and safety laws and regulations worldwide could adversely impact our business, financial condition, results of operations, cash flows, ability to pay dividends or repurchase shares, and/or stock price56% rewritten
3. 18procedures or other risk management efforts are not effective, our facilities may be adversely affected, and operations would experience significant impact or disruptionNew
4. 19The pharmaceutical industry is heavily regulated, and we face significant costs and uncertainties associated with our efforts to comply with applicable laws and regulations
5. 20The occurrence of any of the above risks could have a material adverse effect on our business, financial condition, results of operations, cash flows, ability to pay dividends or repurchase shares, and/or stock price
6. 21If we are unable to successfully introduce new products in a timely manner, our future revenue and profitability may be adversely affected
7. 22In the EU and other countries and regions, there is no exclusivity period for the first generic product. The European Commission or national regulatory agencies may grant marketing authorizations to any number of generics
8. 23We expend a significant amount of resources on R&D efforts that may not lead to successful product introductions53% rewritten
9. 24Even if our products in development receive regulatory approval, such products may not achieve expected levels of market acceptance
10. 25Our business is highly dependent upon market perceptions of us, our products and brands, and the safety and quality of our products and brands, as well as the effectiveness of our sales and marketing activities, and we may be adversely impacted by negative publicity or findings
11. 26A significant portion of our revenues is derived from sales to a limited number of customers
12. 27We have a limited number of manufacturing facilities and certain third-party suppliers produce a substantial portion of our API and products, some of which require a highly exacting and complex manufacturing process
13. 28Our future success is highly dependent on our ability to attract, motivate and retain key personnel
14. 29We rely on the effectiveness of our patents, trademarks, confidentiality agreements and other measures to protect our intellectual property rights
15. 30We are involved in various legal proceedings and certain government inquiries and may experience unfavorable outcomes of such proceedings or inquiries
16. 31We are increasingly dependent on IT and information systems and our systems and infrastructure face certain risks, including cybersecurity and data leakage risks
17. 32We are subject to data privacy and security laws and regulations in many different jurisdictions and countries where we do business, and our or our vendors’ inability to comply could result in fines, penalties, or reputational damage, and could impact the way we operate our business49% rewritten
18. 33Similar initiatives could increase the cost of developing, implementing or maintaining our IT systems, require us to allocate more resources to compliance initiatives or increase our costs75% rewritten
19. 34Incorporating ML, AI and other emerging technologies into our products, services and operations may result in legal and regulatory risks, reputational harm or have other adverse consequences to our business, financial condition or results of operationsNew
20. 35Increasing scrutiny and evolving expectations from customers, regulators, governments, investors, lenders, employees, and other stakeholders with respect to our environmental, social and governance practices may impose additional costs on us or expose us to new or additional risks
21. 36Our business and operations are subject to risks related to climate change
22. 37There can be no guarantee that we will continue to pay dividends or repurchase shares under our share repurchase program
23. 38If tax authorities determine that the intercompany pricing applied to our cross-border arrangements is inconsistent with the arms’ length standard or otherwise ineffective, our tax liabilities could increaseNew
24. 39We may not be able to maintain competitive financial flexibility and our corporate tax rate which could adversely affect us and our shareholders24% rewritten
25. 40Unanticipated changes in our tax provisions or exposure to additional income tax liabilities and changes in income tax laws and tax rulings may have a significant adverse impact on our effective tax rate and income tax expense
26. 41Viatris may be subject to significant U.S. tax liabilities or be obligated to indemnify Pfizer for any such tax liability imposed on Pfizer in connection with the Combination
27. 42Currency fluctuations and changes in exchange rates have impacted and could continue to adversely affect our business, financial condition, results of operations, cash flows, ability to pay dividends or repurchase shares, and/or stock price
28. 43We have significant indebtedness, which could lead to adverse consequences or adversely affect our financial position and prevent us from fulfilling our obligations under such indebtedness, and any refinancing of this debt could be at significantly higher interest rates
29. 44We must maintain adequate internal controls and be able to provide an assertion as to the effectiveness of such controls on an annual basis
30. 45Viatris has suffered and in the future could suffer additional losses due to impairment charges
31. 46Viatris may be adversely affected by disruptions in the credit markets, including disruptions that reduce customers’ access to credit and increase the costs to customers of obtaining credit32% rewritten
32. 47Viatris has certain material obligations relating to defined benefit pension and termination benefit programs21% rewritten

General Risks

1. 48The market price of our common stock has been and may continue to be volatile, and the value of your investment could materially decline
2. 49The expansion of social media platforms presents new risks and challenges
3. 50Provisions in the Viatris Charter and Viatris Bylaws and of applicable law may prevent or delay an acquisition of Viatris, which could decrease the trading price of Viatris common stock
4. 51The exclusive forum provisions in the Viatris Charter could discourage lawsuits against Viatris and its directors and officers