Financial Performance - Revenue for the three months ended September 30, 2025, was $17,600.8 million, a 54% increase from $11,439.1 million in 2024[133] - Net income for the same period increased to $5,582.5 million, compared to $970.3 million in 2024, representing a significant increase[133] - Earnings per share (diluted) rose to $6.21 for the three months ended September 30, 2025, up from $1.07 in 2024, marking a 128% increase[133] - U.S. revenue increased by 45% to $11.30 billion for the three months ended September 30, 2025, compared to $7.81 billion in 2024[153] - Revenue outside the U.S. rose 74% to $6.30 billion for the three months ended September 30, 2025, up from $3.63 billion in 2024[153] - Mounjaro revenue increased by 109% to $6.52 billion for the three months ended September 30, 2025, compared to $3.11 billion in 2024[155] - Gross margin for the three months ended September 30, 2025, was $14.59 billion, a 57% increase from $9.27 billion in 2024[159] Research and Development - The company submitted applications for tirzepatide for pediatric and adolescent type 2 diabetes to the FDA and EC for approval[135] - A Phase 3 trial for tirzepatide for cardiovascular outcomes in type 2 diabetes met its primary endpoint[135] - Research and development expenses rose by 27% to $3.47 billion for the three months ended September 30, 2025, compared to $2.73 billion in 2024[161] Regulatory and Legislative Impact - The Inflation Reduction Act of 2022 requires HHS to set prices for certain drugs, which may significantly impact the company's business strategies[139] - Regulatory focus on business combinations may delay or increase costs of business development activities, impacting the company's financial position[149] - The OBBBA enacted in July 2025 modified U.S. tax laws, affecting the company's income tax expense, which was $350.3 million for the three months ended September 30, 2025[146] Financial Position - Cash and cash equivalents increased to $9.79 billion as of September 30, 2025, from $3.27 billion as of December 31, 2024[169] - Total debt increased to $42.51 billion as of September 30, 2025, up from $33.64 billion as of December 31, 2024[172] - During the nine months ended September 30, 2025, the company repurchased $2.60 billion of shares under its $15.00 billion share repurchase program[174] - The company declared a fourth-quarter dividend of $1.50 per share, totaling approximately $1.34 billion, payable on December 10, 2025[175] Currency and Market Risks - The company continues to face foreign currency exchange rate risks, primarily against the euro, Japanese yen, Chinese yuan, and British pound sterling[150] - The company has foreign currency risk exposure primarily against the U.S. dollar, with fluctuations involving the euro, Japanese yen, Chinese yuan, and British pound sterling[177] - As of September 30, 2025, a hypothetical 10 percent change in currency exchange rates would not have a material impact on earnings, cash flows, or financial position over a one-year period[177] Investor Communication - The company provides access to its SEC filings, including annual reports on Form 10-K and quarterly reports on Form 10-Q, through its website[179] - Important information for investors is routinely posted in the "Investors" section of the company's website, which may include material, non-public information[181] - The company utilizes social media channels to communicate with investors and the public about its business and products, which could be deemed material information[181] - For a detailed discussion of market risk, refer to the "Quantitative and Qualitative Disclosures About Market Risk" in the Annual Report on Form 10-K for the year ended December 31, 2024[182] Accounting and Estimates - There have been no material changes to the company's critical accounting estimates since the Annual Report on Form 10-K for the year ended December 31, 2024[178]
Lilly(LLY) - 2025 Q3 - Quarterly Report