What the changes say
- Mounjaro and Zepbound drove 56% of 2025 revenue, making cardiometabolic demand, competition, pricing, supply, and safety especially consequential.
- Lilly agreed to lower Medicaid and certain U.S. drug prices and pursue more balanced developed-market pricing.
- Manufacturing expansion and third-party relationships are increasing alongside anticipated product demand and AI adoption.
- Patent challenges and potential EU intellectual-property changes could weaken protection for innovative medicines.
What changed since the prior 10-K
New
- NewRisks Related to Our Business and Industry
We and our products face intense competition, and such competition could have a material adverse effect on our business
Competition is intensifying globally, including from China, requiring innovative, cost-effective medicines that deliver value to patients and payers.
- NewRisks Related to Our Business and Industry
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
Governments and private payers are restricting drug prices, reimbursement, and access; Lilly agreed to lower certain U.S. prices.
- NewRisks Related to Our Business and Industry
Pharmaceutical products can develop safety or efficacy concerns, which could have a material adverse effect on our revenues, income, and reputation
Post-launch evidence from larger, longer-term patient use could reveal safety or efficacy problems that reduce product acceptance and sales.
- NewRisks Related to Our Business and Industry
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
Six products generated over $3 billion each and 82% of 2025 revenue, with Mounjaro and Zepbound alone contributing 56%.
- NewRisks Related to Our Intellectual Property
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
Trulicity is expected to lose significant patent and remaining data protection within the next few years, exposing revenue to generic competition.
- NewRisks Related to Our Intellectual Property
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
Patent-law changes, including proposed EU reforms, could reduce intellectual-property protection and undermine returns on Lilly’s research and development investments.
- NewRisks Related to Our Operations
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
Cyberattacks, IT failures, third-party system breaches, or privacy-law violations could expose trade secrets, clinical data, and employee or patient information.
- NewRisks Related to Our Operations
Manufacturing, quality, or supply chain difficulties, disruptions, or shortages could lead to product supply problems or other negative outcomes
Manufacturing and supply-chain disruptions, demand variability, or shortages could delay sales, raise costs, reduce opportunities, and invite competitors.
- NewRisks Related to Our Operations
Reliance on third-party relationships and outsourcing arrangements could adversely affect our business
Greater reliance on suppliers, contract manufacturers, logistics providers, clinical organizations, AI vendors, and other partners could impair development, production, or distribution.
- NewRisks Related to Our Operations
Our use of artificial intelligence (AI) or other emerging technologies could adversely impact us
Inadequate AI outputs, slower adoption than competitors, or AI-related regulatory and cybersecurity problems could undermine Lilly’s investments and operations.
- NewRisks Related to Doing Business Internationally
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
Global downturns, trade disruptions, geopolitical tensions, and financially stressed governments, customers, suppliers, or partners could reduce demand, collections, or supply performance.
- NewRisks Related to Doing Business Internationally
Changes in foreign currency rates, interest rate risks, and inflation or deflation affect our results of operations
A strong U.S. dollar, interest-rate changes, and inflation could increase costs or reduce international earnings, with extreme currency devaluation threatening local affordability.
- NewRisks Related to Litigation and Government Regulation
We are party to litigation and investigations, which could adversely affect our business
- NewRisks Related to Litigation and Government Regulation
We are subject to evolving and complex tax laws, which may result in additional liabilities
- NewRisks Related to Litigation and Government Regulation
Regulatory compliance problems could be damaging to the company
Dropped
- DroppedRisks Related to Our Business and Industry
See Item 1, "Business—Research and Development—Phases of New Drug Development," Item 7, "Management's Discussion and Analysis—Executive Overview—Clinical Development Pipeline" and Item 8, "Financial Statements and Supplementary Data—Note 6: Inventories," for more details about our current product pipeline
Reworded
- 41% rewrittenRisks Related to Our Intellectual Property
In recent years, U.S. government officials have proposed the exercise of "march-in-rights" and various other measures that, if enacted, could have a negative impact on our patent rights. If any such proposals are adopted, our business and results of operations could be adversely affected
The U.S. patent-challenge risk now covers competitors or other parties seeking USPTO invalidation through IPR, not only competitors.
- 27% rewrittenRisks Related to Our Business and Industry
There are many difficulties and uncertainties inherent in pharmaceutical research and development, the introduction of new products and indications, business development activities to enhance or refine our product pipeline, and commercialization of our products
The research-and-development risk now includes disappointing results after significant value attribution, manufacturing preparation, or inventory investment.
All 17 risk factors
Headings as the filing states them, in filing order.
Risks Related to Our Business and Industry
- 01There are many difficulties and uncertainties inherent in pharmaceutical research and development, the introduction of new products and indications, business development activities to enhance or refine our product pipeline, and commercialization of our products27% rewritten
- 02We and our products face intense competition, and such competition could have a material adverse effect on our businessNew
- 03Our 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 businessNew
- 04Pharmaceutical products can develop safety or efficacy concerns, which could have a material adverse effect on our revenues, income, and reputationNew
- 05We 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 risksNew
Risks Related to Our Intellectual Property
- 06We 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 productsNew
- 07Our long-term success depends on intellectual property protection; if our intellectual property rights are invalidated, circumvented, or weakened, our business will be adversely affectedNew
- 08In recent years, U.S. government officials have proposed the exercise of "march-in-rights" and various other measures that, if enacted, could have a negative impact on our patent rights. If any such proposals are adopted, our business and results of operations could be adversely affected41% rewritten
Risks Related to Our Operations
- 09Failure, 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 reputationNew
- 10Manufacturing, quality, or supply chain difficulties, disruptions, or shortages could lead to product supply problems or other negative outcomesNew
- 11Reliance on third-party relationships and outsourcing arrangements could adversely affect our businessNew
- 12Our use of artificial intelligence (AI) or other emerging technologies could adversely impact usNew
Risks Related to Doing Business Internationally
- 13Our global operations subject us to risks, including as related to uneven economic growth or downturns, international trade, and other global disruptions, geopolitical tensions, or disputesNew
- 14Changes in foreign currency rates, interest rate risks, and inflation or deflation affect our results of operationsNew
Risks Related to Litigation and Government Regulation
- 15We are party to litigation and investigations, which could adversely affect our businessNew
- 16We are subject to evolving and complex tax laws, which may result in additional liabilitiesNew
- 17Regulatory compliance problems could be damaging to the companyNew
About this page
The headings are the filing's own. The one-line readings and the overview are automated and can be wrong: read Item 1A of the 10-K for the exact wording.