Viatris (VTRS) risk factors: FY2025 10-K

Item 1A of the 10-K for the period ending 2025-12-31, filed 2026-02-26. 45 risk factor headings as filed. Read Item 1A in full · The whole 10-K · What changed since FY2024

5new since FY2024
2reworded
2removed
38unchanged

Headings mentioning a theme: Tariffs 1 · AI 1 · Cybersecurity 1 · China 1 · Interest rates 0. Compare across the S&P 500.

Strategic Risks

10
  1. We 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 transactions.reworded
  2. Viatris’ 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 price.new
  3. There 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 price.reworded
  4. The 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 price.new
  5. The imposition of tariffs on, or other trade restrictions or domestic sourcing requirements in, the territories and countries where we, our partners, suppliers, or customers do business, as well as any retaliatory actions with 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 price.newTariffs
  6. We 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.
  7. Healthcare reform legislation could have a material adverse effect on our business.
  8. We have significant operations globally, which exposes us to the risks inherent in conducting our business internationally.
  9. The illegal distribution and sale by third parties of counterfeit or IP-infringing versions of our products or of diverted or stolen products could have a negative impact on our reputation and our business.
  10. A relatively small group of products may represent a significant portion of our revenues, net sales, gross profit, or net earnings from time to time.

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Operational Risks

9
  1. Current and changing economic conditions, including inflation, may adversely affect our industry, business, partners and suppliers.
  2. Failure 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 price.
  3. The pharmaceutical industry is heavily regulated, and we face significant costs and uncertainties associated with our efforts to comply with applicable laws and regulations.
  4. If we are unable to successfully introduce new products in a timely manner, our future revenue and profitability may be adversely affected.
  5. We expend a significant amount of resources on R&D efforts that may not lead to successful product introductions.
  6. Our 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.
  7. A significant portion of our revenues is derived from sales to a limited number of customers.
  8. We 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.
  9. Our future success is highly dependent on our ability to attract, motivate and retain key personnel.

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Compliance Risks

10
  1. We are subject to the U.S. Foreign Corrupt Practices Act, U.S. Foreign Extortion Prevention Act, the U.K. Bribery Act, Chinese anti-corruption laws and similar worldwide anti-corruption laws, which impose restrictions on certain conduct and may carry substantial fines and penalties.China
  2. Our competitors, including branded pharmaceutical companies, and/or other third parties, may allege that we or our suppliers are infringing upon their intellectual property, including in an “at risk launch” situation, which could result in substantial monetary damages, impact our ability to launch a product and/or our ability to continue marketing a product, and/or force us to expend substantial resources in resulting litigation, the outcome of which is uncertain.
  3. We rely on the effectiveness of our patents, trademarks, confidentiality agreements and other measures to protect our intellectual property rights.
  4. Our reporting and payment obligations related to our participation in U.S. federal healthcare programs, including Medicare, Medicaid and the VA, are complex and often involve subjective decisions that could change as a result of new business circumstances, new laws, regulations or agency guidance, or advice of legal counsel. Any failure to comply with those obligations could subject us to investigation, penalties, and sanctions.
  5. We are involved in various legal proceedings and certain government inquiries and may experience unfavorable outcomes of such proceedings or inquiries.
  6. We are increasingly dependent on IT and information systems and our systems and infrastructure face certain risks, including cybersecurity and data leakage risks.Cybersecurity
  7. We 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 business.
  8. Incorporating 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 operations.newAI
  9. Increasing 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.
  10. Our business and operations are subject to risks related to climate change.

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Finance Risks

11
  1. There can be no guarantee that we will continue to pay dividends or repurchase shares under our share repurchase program.
  2. If 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 increase.new
  3. We may not be able to maintain competitive financial flexibility and our corporate tax rate which could adversely affect us and our shareholders.
  4. Unanticipated 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.
  5. Viatris 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.
  6. Currency 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.
  7. There are inherent uncertainties involved in estimates, judgments and assumptions used in the preparation of financial statements in accordance with U.S. GAAP. Any future changes in estimates, judgments and assumptions used or necessary revisions to prior estimates, judgments or assumptions or changes in accounting standards could lead to a restatement or revision to previously issued financial statements.
  8. We must maintain adequate internal controls and be able to provide an assertion as to the effectiveness of such controls on an annual basis.
  9. Viatris has suffered and in the future could suffer additional losses due to impairment charges.
  10. Viatris 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 credit.
  11. Viatris has certain material obligations relating to defined benefit pension and termination benefit programs.

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General Risks

5
  1. The market price of our common stock has been and may continue to be volatile, and the value of your investment could materially decline.
  2. The expansion of social media platforms presents new risks and challenges.
  3. Provisions 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. The exclusive forum provisions in the Viatris Charter could discourage lawsuits against Viatris and its directors and officers.
  5. Our business and operations could be negatively affected by pressures from outside of the control of the company, including, but not limited to, shareholder actions, government regulations and disclosure requirements, and other market dynamics, which could cause us to incur significant expenses, hinder execution of our business strategy and negatively impact our share price.

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No longer in Item 1A

2

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

  1. The integration of acquired businesses as well as restructuring programs have presented and may in the future present significant challenges.
  2. If the intercompany terms of cross border arrangements that we have among our subsidiaries are determined to be inappropriate or ineffective, our tax liability may increase.

Headings are the lines of Item 1A set wholly in bold or italics, as the parser reads them, without the introductory paragraph that opens the section. A heading is new when no heading in the prior 10-K matches it after ignoring case and punctuation, and reworded when it shares at least 60 percent of its words with one that went away. Source: the filing on sec.gov.