Eli Lilly (LLY) risk factors: FY2025 10-K

1. Pharmaceutical research and development is very costly and highly uncertain; we may not succeed in developing, licensing, or acquiring commercially successful products sufficient in number or value to replace revenues of products that have lost or will lose intellectual property protection or are displaced by competing products or therapies.
2. We and our products face intense competition, and such competition could have a material adverse effect on our business.
3. Our business is subject to government price controls and other public and private restrictions on pricing, reimbursement, and access for our drugs, which could have a material adverse effect on our results of operations, reputation, or business.
4. Pharmaceutical products can develop safety or efficacy concerns, which could have a material adverse effect on our revenues, income, and reputation.
5. We derive a significant percentage of our total revenue from relatively few products and sell our products through consolidated supply chain entities, which subjects us to various risks.

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1. We depend on products with intellectual property protection for most of our revenues, cash flows, and earnings; the loss of effective intellectual property protection for certain of our products has resulted, and in the future is likely to continue to result, in rapid and severe declines in revenues for those products.
2. Our long-term success depends on intellectual property protection; if our intellectual property rights are invalidated, circumvented, or weakened, our business will be adversely affected.

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1. Failure, inadequacy, breach of, or unauthorized access to, our IT systems or those of our third-party service providers, unauthorized access to our confidential information, or violations of data protection laws, could result in material harm to our business and reputation.
2. Manufacturing, quality, or supply chain difficulties, disruptions, or shortages could lead to product supply problems or other negative outcomes.
3. Reliance on third-party relationships and outsourcing arrangements could adversely affect our business.
4. Our use of artificial intelligence (AI) or other emerging technologies could adversely impact us.AI

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1. Our global operations subject us to risks, including as related to uneven economic growth or downturns, international trade, and other global disruptions, geopolitical tensions, or disputes.
2. Changes in foreign currency rates, interest rate risks, and inflation or deflation affect our results of operations.Interest rates

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1. We are party to litigation and investigations, which could adversely affect our business.
2. We are subject to evolving and complex tax laws, which may result in additional liabilities.
3. Regulatory compliance problems could be damaging to the company.

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