Management's Discussion and Analysis of Results of Operations and Financial Condition
(Tables present dollars in millions, except per-share data, and numbers may not add due to rounding)
General
Management's discussion and analysis of results of operations and financial condition is intended to assist the reader in understanding and assessing significant changes and trends related to our results of operations and financial position. This discussion and analysis should be read in conjunction with the consolidated condensed financial statements and accompanying footnotes in Part I, Item 1 of this Quarterly Report on Form 10-Q. Certain statements in this Part I, Item 2 of this Quarterly Report on Form 10-Q constitute forward-looking statements. Various risks and uncertainties, including those discussed in "Forward-Looking Statements" in this Quarterly Report on Form 10-Q and "Risk Factors" in Part I, Item 1A of our Annual Report on Form 10-Kfor the year ended December 31, 2024, may cause our actual results, financial position, and cash generated from operations to differ from these forward-looking statements.
EXECUTIVE OVERVIEW
This section provides an overview of our financial results, updates to our clinical development pipeline, and other matters affecting our company and industry.
Financial Results
The following table summarizes certain financial information:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30,
|
|
Percent Change
|
|
Nine Months Ended September 30,
|
|
Percent Change
|
|
|
2025
|
|
2024
|
|
|
2025
|
|
2024
|
|
|
Revenue
|
$
|
17,600.8
|
|
|
$
|
11,439.1
|
|
|
54
|
|
$
|
45,887.0
|
|
|
$
|
31,509.9
|
|
|
46
|
|
Net income
|
5,582.5
|
|
|
970.3
|
|
|
NM
|
|
14,002.3
|
|
|
6,180.2
|
|
|
127
|
|
Earnings per share - diluted
|
6.21
|
|
|
1.07
|
|
|
NM
|
|
15.56
|
|
|
6.83
|
|
|
128
|
NM - not meaningful
Revenue increased for the three and nine months ended September 30, 2025, driven by increased volume, partially offset by lower realized prices. The increased volume and lower realized prices during the three and nine months ended September 30, 2025 were primarily driven by Mounjaro and Zepbound.
Net income and earnings per share for the three and nine months ended September 30, 2025 increased primarily due to higher gross margin, partially offset by increased marketing, selling, and administrative expenses and research and development expenses.
See "Results of Operations" for additional information.
Clinical Development Pipeline Updates
Our long-term success depends on our ability to continually discover or acquire, develop, and commercialize innovative new medicines. See "Management's Discussion and Analysis of Results of Operations and Financial Condition-Executive Overview-Clinical Development Pipeline" in Part II, Item 7 of our Annual Report on Form 10-Kfor the year ended December 31, 2024 for select new molecular entities (NMEs) and new indication line extension (NILEX) products in Phase 2 or Phase 3 clinical trials or that were submitted for regulatory review or received regulatory approval in the U.S., European Union (EU), or Japan. The following reflects certain developments since our Annual Report on Form 10-Kfor the year ended December 31, 2024:
|
|
|
|
|
|
|
|
Compound
|
Development
|
|
Tirzepatide
|
Submitted our application for tirzepatide for pediatric and adolescent type 2 diabetes to the U.S. Food and Drug Administration (FDA) and European Commission (EC) for approval.
|
|
Announced that a Phase 3 trial for tirzepatide for cardiovascular outcomes in type 2 diabetes met the primary endpoint.
|
|
A Phase 3 trial was initiated for tirzepatide for type 1 diabetes.
|
|
Withdrew our U.S. application for tirzepatide for heart failure with preserved ejection fraction.
|
|
Insulin Efsitora Alfa
|
Submitted our application for insulin efsitora alfa for type 2 diabetes to the FDA and EC for approval.
|
|
Muvalaplin
|
A Phase 3 trial was initiated for muvalaplin for atherosclerotic cardiovascular disease.
|
|
Orforglipron
|
Announced that Phase 3 trials for orforglipron for obesity met their primary and all key secondary endpoints.
|
|
Announced that Phase 3 trials for orforglipron for type 2 diabetes met their primary and all key secondary endpoints.
|
|
A Phase 3 trial was initiated for orforglipron for hypertension and overweight or obesity.
|
|
A Phase 3 trial was initiated for orforglipron for osteoarthritis pain of the knee and overweight or obesity.
|
|
A Phase 3 trial was initiated for orforglipron for stress urinary incontinence and overweight or obesity.
|
|
Retatrutide
|
A Phase 3 trial was initiated for retatrutide for chronic low back pain and overweight or obesity.
|
|
Mirikizumab (Omvoh)
|
Japan's Ministry of Health, Labour and Welfare approved mirikizumab for treatment of Crohn's disease.
|
|
Donanemab (Kisunla)
|
The EC approved donanemab for the treatment of early symptomatic Alzheimer's disease.
|
|
Imlunestrant (Inluriyo)
|
The FDA approved imlunestrant for treatment of ER+, HER2-, ESR1-mutated advanced or metastatic breast cancer.
|
|
Pirtobrutinib (Jaypirca)
|
The EC approved pirtobrutinib for treatment of chronic lymphocytic leukemia.
|
|
Announced that Phase 3 trials for pirtobrutinib for chronic lymphocytic leukemia or small lymphocytic leukemia met their primary endpoints.
|
|
Olomorasib(1)
|
A Phase 3 trial was initiated for olomorasib for resected adjuvant non-small cell lung cancer.
|
|
A Phase 3 trial was initiated for olomorasib for unresected adjuvant non-small cell lung cancer.
|
(1)The FDA granted Breakthrough Therapy designation for the treatment of certain newly diagnosed metastatic KRAS G12C-mutant lung cancers. Breakthrough Therapy designation is designed to expedite the development and review of potential medicines that are intended to treat a serious condition when preliminary clinical evidence indicates that the treatment may demonstrate substantial improvement on a clinically significant endpoint(s) over already available therapies.
Other Matters
Trends Affecting Pharmaceutical Pricing, Reimbursement, and Access and Certain Other Regulatory Developments
Global concern over access to, and affordability of, pharmaceutical products continues to drive debate and action, as well as cost containment efforts by governmental authorities and scrutiny of pricing and access disparities. Cost containment measures include the use of mandated discounts, price reporting requirements, mandated reference prices, restrictive formularies, changes to available intellectual property protections, as well as other efforts.
Reforms, initiatives, and other actions, including those that may stem from political initiatives, periods of uneven economic growth or downturns, or as a result of inflation or deflation, trade and other global disputes and interruptions including related to tariffs, trade protection measures, and similar restrictions, the emergence or escalation of, and responses to, international tension and conflicts, or government budgeting priorities, are expected to continue to result in added pressure on cost, pricing, reimbursement, and access for our products.
For example, in May 2025, the U.S. presidential administration issued an executive order intended, in part, to encourage or impose the use of most-favored-nation pricing to tie U.S. prescription drug prices with prices in selected comparably developed nations. In July 2025, we and other pharmaceutical companies received letters from the U.S. presidential administration reiterating certain drug pricing objectives. We and other pharmaceutical manufacturers face uncertainty on the implementation of these objectives, which could result in reduced prices and reimbursement for certain of our or competing products and may significantly impact our business and results of operations. Additionally, in July 2025, the OBBBA was enacted into law. In addition to tax impacts, the OBBBA implements spending cuts to certain federal healthcare programs, including Medicaid and the Affordable Care Act.
The Inflation Reduction Act of 2022 (IRA) requires HHS to effectively set prices for certain single-source drugs and biologics reimbursed under Medicare Part B and Part D. Currently, these government prices generally apply beginning at nine years (for medicines approved under a New Drug Application) or thirteen years (for medicines approved under a Biologics License Application) following FDA approval or licensure for the molecule. In August 2023, HHS selected Jardiance, which is part of our collaboration with Boehringer Ingelheim, as one of the first ten medicines subject to government-set prices effective in 2026 and we expect additional of our significant products will be selected in future years. The IRA has, and will continue to, meaningfully influence our business strategies and those of our competitors and could significantly impact our business and consolidated results of operations.
Other policies, regulations, legislation, or enforcement, including those proposed or pursued by lawmakers, regulators, and other authorities in the U.S. and worldwide, have and may continue to adversely impact our business and consolidated results of operations. For example, the U.S. and other countries have recently imposed or reached alignment on new tariffs. In some cases, imposed tariffs have been paused but may come into effect quickly and unpredictably. While pharmaceuticals are exempt from certain of these tariffs, such exemptions may be terminated or may not apply to any future tariffs. The precise impact of tariffs, trade protection measures, and other restrictions depend on their ultimate scope, timing, and other factors. If enacted, additional restrictions could result in supply disruptions or delays, further increase costs, or otherwise have a negative impact on our business. Given the nature of pharmaceutical regulation and commercialization, we may not be able to share the burden of increased costs from tariffs and related impacts to any meaningful degree.
Private payers and pharmacy benefit managers in the U.S. continue to significantly impact the market for pharmaceuticals through negotiation of access, manufacturer price or rebate concessions and pharmacy reimbursement rates. Restrictive or unfavorable pricing, coverage, or reimbursement determinations for our medicines or product candidates by governments, regulatory agencies, courts, or private actors have and may continue to adversely impact our business and consolidated results of operations. In addition, we are engaged in litigation and investigations related to the 340B program, access to insulin, pricing, product safety, and other matters that, if resolved adversely to us, could negatively impact our business and consolidated results of operations. It is not currently possible to predict the overall potential adverse impact to us or the general pharmaceutical industry of continued cost containment efforts worldwide.
In addition, regulatory issues concerning compliance with current Good Manufacturing Practices, quality assurance, safety signals, evolving standards, and increased scrutiny around excipients and potential impurities such as nitrosamines, and similar regulations and standards (and comparable foreign regulations and standards) for our products in some cases lead to regulatory and legal actions, product recalls and seizures, fines and penalties, interruption of production leading to product shortages, import bans or denials of import certifications, inability to realize the benefit of capital expenditures, or delays or denials in new product approvals, line extensions or supplemental approvals of current products pending resolution of the issues, or other negative impacts, any of which result in reputational harm or adversely affect our business.
Incretin Medicines
At various times during 2024, demand for our incretin medicines exceeded production. Tirzepatide supply currently exceeds demand in the U.S. Demand in launched markets remains dynamic, and increases or changes in demand, by dose or overall, as well as the complex supply chain, may result in periodic unavailability of certain presentations and dose levels at certain locations even when total tirzepatide supply can meet demand. Production increases and delivery presentation initiatives are ongoing, and additional capacity is expected to be operational over the next several years.
We continue to see the production, marketing, and sale of counterfeit, misbranded, adulterated, and compounded incretins. These practices may impact patient safety and undermine regulatory drug approval processes. While the FDA has confirmed that the previous shortage of tirzepatide has ended and that compounding pharmacies are required to cease mass production, we cannot guarantee adequate regulation or compliance. Lilly will continue to consider all options, including filing lawsuits where appropriate, to address unlawful practices and the patient safety risks of unapproved, untested, and manipulated drugs.
Tax Matters
We are subject to income taxes and various other taxes in the U.S. and in many foreign jurisdictions; therefore, changes in both domestic and international tax laws or regulations have affected and may affect our effective tax rate, results of operations, and cash flows. The U.S. and countries around the world are actively proposing and enacting tax law changes. Further, actions taken with respect to tax-related matters by associations such as the Organisation for Economic Co-operation and Development (OECD) and the European Commission could influence tax laws in countries in which we operate. Tax authorities in the U.S. and other jurisdictions in which we do business routinely examine our tax returns and are expected to increase their scrutiny of cross-border tax issues. Changes to existing U.S. and foreign tax laws and increased scrutiny by tax authorities in the U.S. and other jurisdictions could have a material adverse impact on our future consolidated results of operations and cash flows.
In July 2025, the OBBBA, which implemented certain U.S. tax law changes, was enacted into law. The OBBBA modified and made permanent several provisions of the Tax Cuts and Jobs Act, including reductions in scheduled increases for the rate of taxation of foreign income, immediate deductibility of U.S. research and development expenses, and reinstatement of 100% bonus depreciation for capital assets. For the three months ended September 30, 2025, we recorded income tax expense of $350.3 million related to adjusting our income tax provision for prior periods of 2025 and remeasuring our deferred tax assets and liabilities in connection with the enactment of OBBBA.
Effective January 1, 2024, several EU and non-EU countries enacted legislation (known as "Pillar Two") that provided for a minimum level of taxation of multinational companies. The increase to income tax expense as a result of the global minimum tax is not expected to be material in current and future years. Our assessment of the impact for 2025 and subsequent years could be affected by legislative guidance and future enactment of additional provisions.
Acquisitions
We invest in external research and technologies and manufacturing capabilities that we believe complement and strengthen our own efforts. These investments can take many forms, including acquisitions, collaborations, investments, and licensing arrangements. We view our business development activity as a way to enhance or refine our pipeline and strengthen our business.
See Note 3 to the consolidated condensed financial statements for further discussion regarding our recent acquisitions.
Continued regulatory focus on business combinations in our industry, including by the Federal Trade Commission and competition authorities in Europe and other jurisdictions, could continue to delay, jeopardize, or increase the costs of our business development activities and may negatively impact our consolidated financial position or results of operations.
Foreign Currency Exchange Rates
As a global company, we face foreign currency risk exposure from fluctuating currency exchange rates, primarily the U.S. dollar against the euro, Japanese yen, Chinese yuan and British pound sterling. While we seek to manage a portion of these exposures through hedging and other risk management techniques, significant fluctuations in currency rates can have a material impact, either positive or negative, on our consolidated results of operations in any given period. There is uncertainty in the future movements in foreign currency exchange rates, and fluctuations in these rates have and could adversely impact our consolidated results of operations and cash flows.
Other Factors
Other factors have had, and may continue to have, an impact on our consolidated results of operations. These factors include cost and wage inflation, supply chain and labor market complexities, international tension and conflicts, uneven economic growth, downturns or uncertainty, risks related to engaging in business globally, including legislation and regulatory action in or regarding foreign jurisdictions, and fluctuations due to channel dynamics or demand for certain products.
See "Business" in Part 1, Item 1 and "Risk Factors" in Part I, Item 1A of our Annual Report on Form 10-Kfor the year ended December 31, 2024 and Note 10 to the consolidated condensed financial statements for additional information and risks and uncertainties that could impact our business and operations, including the matters described within this Executive Overview.
RESULTS OF OPERATIONS
Revenue
The following table summarizes our revenue activity by region:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30,
|
|
Percent Change
|
Nine Months Ended September 30,
|
|
Percent Change
|
|
|
2025
|
|
2024
|
|
2025
|
|
2024
|
|
|
U.S.
|
$
|
11,300.0
|
|
|
$
|
7,813.6
|
|
|
45
|
$
|
30,603.6
|
|
|
$
|
21,343.2
|
|
|
43
|
|
Outside U.S.
|
6,300.8
|
|
|
3,625.5
|
|
|
74
|
15,283.4
|
|
|
10,166.7
|
|
|
50
|
|
Revenue
|
$
|
17,600.8
|
|
|
$
|
11,439.1
|
|
|
54
|
$
|
45,887.0
|
|
|
$
|
31,509.9
|
|
|
46
|
The following are components of the change in revenue compared with the prior year:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
|
|
2025 vs. 2024
|
|
2025 vs. 2024
|
|
|
U.S.
|
Outside U.S.
|
Consolidated
|
|
U.S.
|
Outside U.S.
|
Consolidated
|
|
Volume
|
60
|
%
|
66
|
%
|
62
|
%
|
|
54
|
%
|
49
|
%
|
52
|
%
|
|
Price
|
(15)
|
|
3
|
|
(10)
|
|
|
(11)
|
|
-
|
|
(7)
|
|
|
Foreign exchange rates
|
-
|
|
6
|
|
2
|
|
|
-
|
|
1
|
|
-
|
|
|
Percent change
|
45
|
%
|
74
|
%
|
54
|
%
|
|
43
|
%
|
50
|
%
|
46
|
%
|
In the U.S. for the three and nine months ended September 30, 2025, the volume increase and the lower realized prices were driven by Zepbound and Mounjaro.
Outside the U.S. for the three and nine months ended September 30, 2025, the volume increase was primarily driven by Mounjaro. The volume increase outside the U.S. for the three and nine months ended September 30, 2025 was also driven by $200.0 million and $570.0 million, respectively, in one-time benefits for Jardiance. See Note 4 to the consolidated condensed financial statements for additional information.
The following table summarizes our revenue, including net product revenue and collaboration and other revenue, by product for the three months ended September 30, 2025 and 2024:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30,
|
|
Percent Change
|
|
|
2025
|
|
2024
|
|
|
U.S.
|
|
Outside U.S.
|
|
Total
|
|
Total
|
|
Mounjaro
|
$
|
3,550.1
|
|
|
$
|
2,965.0
|
|
|
$
|
6,515.1
|
|
|
$
|
3,112.7
|
|
|
109
|
|
Zepbound
|
3,568.3
|
|
|
19.8
|
|
|
3,588.1
|
|
|
1,257.8
|
|
|
185
|
|
Verzenio
|
880.3
|
|
|
589.8
|
|
|
1,470.2
|
|
|
1,369.3
|
|
|
7
|
|
Other products
|
3,301.3
|
|
|
2,726.2
|
|
|
6,027.4
|
|
|
5,699.3
|
|
|
6
|
|
Revenue
|
$
|
11,300.0
|
|
|
$
|
6,300.8
|
|
|
$
|
17,600.8
|
|
|
$
|
11,439.1
|
|
|
54
|
The following table summarizes our revenue, including net product revenue and collaboration and other revenue, by product for the nine months ended September 30, 2025 and 2024:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended September 30,
|
|
Percent Change
|
|
|
2025
|
|
2024
|
|
|
U.S.
|
|
Outside U.S.
|
|
Total
|
|
Total
|
|
Mounjaro
|
$
|
9,507.8
|
|
|
$
|
6,048.0
|
|
|
$
|
15,555.8
|
|
|
$
|
8,010.0
|
|
|
94
|
|
Zepbound
|
9,253.6
|
|
|
27.7
|
|
|
9,281.3
|
|
|
3,018.4
|
|
|
NM
|
|
Verzenio
|
2,467.0
|
|
|
1,651.4
|
|
|
4,118.3
|
|
|
3,751.5
|
|
|
10
|
|
Other products
|
9,375.2
|
|
|
7,556.3
|
|
|
16,931.6
|
|
|
16,730.0
|
|
|
1
|
|
Revenue
|
$
|
30,603.6
|
|
|
$
|
15,283.4
|
|
|
$
|
45,887.0
|
|
|
$
|
31,509.9
|
|
|
46
|
NM - not meaningful
Revenue of Mounjaro increased 49 percent and 50 percent in the U.S. during the three and nine months ended September 30, 2025, respectively, reflecting strong demand, partially offset by lower realized prices. Revenue outside the U.S. during the three and nine months ended September 30, 2025 was $2.97 billion and $6.05 billion, respectively, compared to $728.0 million and $1.69 billion during the three and nine months ended September 30, 2024, respectively, primarily driven by volume growth.
Revenue of Zepbound in the U.S. during the three and nine months ended September 30, 2025 was $3.57 billion and $9.25 billion, respectively, compared to $1.26 billion and $3.02 billion during the three and nine months ended September 30, 2024, respectively, primarily driven by increased demand, partially offset by lower realized prices.
Revenue of Verzenio was relatively flat in the U.S. during the three months ended September 30, 2025, reflecting an increase in volume which was offset by lower realized prices. Revenue of Verzenio increased 4 percent in the U.S. during the nine months ended September 30, 2025 reflecting an increase in volume, partially offset by lower realized prices. Revenue outside the U.S. increased 20 percent during the three and nine months ended September 30, 2025, primarily driven by volume growth and, to a lesser extent, favorable impact on foreign exchange rates.
Gross Margin, Costs, and Expenses
The following table summarizes our gross margin, costs, and expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30,
|
|
Percent Change
|
|
Nine Months Ended September 30,
|
|
Percent Change
|
|
|
2025
|
|
2024
|
|
|
2025
|
|
2024
|
|
|
Gross margin
|
$
|
14,592.5
|
|
|
$
|
9,268.3
|
|
|
57
|
|
$
|
38,206.7
|
|
|
$
|
25,495.4
|
|
|
50
|
|
Gross margin as a percent of revenue
|
82.9
|
%
|
|
81.0
|
%
|
|
|
|
83.3
|
%
|
|
80.9
|
%
|
|
|
|
Research and development
|
$
|
3,465.7
|
|
|
$
|
2,734.1
|
|
|
27
|
|
$
|
9,535.5
|
|
|
$
|
7,968.1
|
|
|
20
|
|
Marketing, selling, and administrative
|
2,740.7
|
|
|
2,099.8
|
|
|
31
|
|
7,962.6
|
|
|
6,169.3
|
|
|
29
|
|
Acquired IPR&D
|
655.7
|
|
|
2,826.4
|
|
|
(77)
|
|
2,381.2
|
|
|
3,091.2
|
|
|
(23)
|
|
Asset impairment, restructuring, and other special charges
|
364.9
|
|
|
81.6
|
|
|
NM
|
|
399.9
|
|
|
516.6
|
|
|
(23)
|
|
Other-net, (income) expense
|
133.1
|
|
|
(62.0)
|
|
|
NM
|
|
462.7
|
|
|
108.5
|
|
|
NM
|
|
Income taxes
|
1,649.9
|
|
|
618.1
|
|
|
167
|
|
3,462.5
|
|
|
1,461.5
|
|
|
137
|
|
Effective tax rate
|
22.8
|
%
|
|
38.9
|
%
|
|
|
|
19.8
|
%
|
|
19.1
|
%
|
|
|
NM - not meaningful
Gross margin as a percent of revenue for the three months ended September 30, 2025 increased 1.9 percentage points, primarily driven by favorable product mix, partially offset by lower realized prices. Gross margin as a percent of revenue for the nine months ended September 30, 2025 increased 2.4 percentage points, primarily driven by favorable product mix and improved cost of production, partially offset by lower realized prices.
Research and development expenses increased 27 percent and 20 percent for the three and nine months ended September 30, 2025, respectively, driven by continued investments in our early and late-stage portfolio.
Marketing, selling, and administrative expenses increased 31 percent and 29 percent for the three and nine months ended September 30, 2025, respectively, primarily driven by promotional efforts supporting ongoing and future launches.
Acquired IPR&D charges for the three months ended September 30, 2025 were primarily related to the acquisition of SiteOne. Acquired IPR&D charges for the nine months ended September 30, 2025 were primarily related to the acquisitions of Scorpion's PI3Kα inhibitor program STX-478 and of SiteOne. Acquired IPR&D charges for the three and nine months ended September 30, 2024 were primarily related to the acquisition of Morphic. See Note 3 to the consolidated condensed financial statements for additional information.
Asset impairment, restructuring, and other special charges for the three and nine months ended September 30, 2025 were primarily related to a litigation charge, as well as acquisition and integration costs associated with the closing of our acquisition of Verve. Asset impairment, restructuring, and other special charges for the nine months ended September 30, 2024 were primarily related to a litigation charge. See Notes 5 and 10 to the consolidated condensed financial statements for additional information.
The effective tax rates were 22.8 percent and 19.8 percent for the three and nine months ended September 30, 2025, respectively, compared to 38.9 percent and 19.1 percent for the three and nine months ended September 30, 2024, respectively, primarily driven by unfavorable tax impacts of non-deductible acquired IPR&D charges, with a larger impact occurring in 2024. As a result of the OBBBA, the effective tax rates for the three and nine months ended September 30, 2025 were unfavorably impacted by incremental tax expense recognized in these periods. See Note 8 to the consolidated condensed financial statements for additional information.
For additional information for other-net, (income) expense, see Note 12 to the consolidated condensed financial statements.
FINANCIAL CONDITION AND LIQUIDITY
We believe our available cash and cash equivalents, together with our ability to generate operating cash flow and our access to short-term and long-term borrowings, are sufficient to fund our existing and planned capital requirements. For a discussion of our capital requirements, see "Management's Discussion and Analysis of Results of Operations and Financial Condition" in Part II, Item 7 of our Annual Report on Form 10-Kfor the year ended December 31, 2024.
We are making investments in global facilities to manufacture existing and future products. These investments, and other capital investments that support our operations, have increased our capital expenditures and will result in meaningfully higher capital expenditures over the next several years.
As we expand our manufacturing capacity in order to meet existing and expected demand of our medicines, we have entered, and expect to continue to enter, into various agreements for contract manufacturing and for supply of materials. Executed agreements related to our medicines in development could, under certain circumstances, require us to pay up to approximately $9 billion if we do not purchase specified amounts of goods or services over the durations of the agreements, which are generally up to 8 years.
Cash and cash equivalents increased to $9.79 billion as of September 30, 2025, compared with $3.27 billion as of December 31, 2024. Refer to the consolidated condensed statements of cash flows for additional information on the significant sources and uses of cash for the nine months ended September 30, 2025 and 2024.
In addition to our cash and cash equivalents, we held total investments of $2.93 billion and $3.37 billion as of September 30, 2025 and December 31, 2024, respectively. See Note 7 to the consolidated condensed financial statements for additional information.
During the nine months ended September 30, 2025, we paid $2.58 billion for acquired IPR&D primarily related to the acquisitions of Scorpion's PI3Kα inhibitor program STX-478 and of SiteOne. See Note 3 to the consolidated condensed financial statements for additional information.
As of September 30, 2025, total debt was $42.51 billion, an increase of $8.86 billion compared with $33.64 billion as of December 31, 2024. In August 2025, we issued $6.00 billion of fixed-rate notes and $750.0 million of floating-rate notes and have used, or expect to use, the net cash proceeds from this offering for general business purposes, including the repayment of commercial paper. In February 2025, we issued $6.50 billion of fixed-rate notes and used the net cash proceeds to fund the acquisition of Scorpion's PI3Kα inhibitor program STX-478 and related fees and expenses and for general business purposes, including the repayment of commercial paper. See Note 7 to the consolidated condensed financial statements for additional information.
As of September 30, 2025, we had a total of $10.45 billion of unused committed bank credit facilities, $10.00 billion of which is available to support our commercial paper program. See Note 7 to the consolidated condensed financial statements for additional information. We believe that amounts accessible through existing commercial paper markets should be adequate to fund short-term borrowing needs.
During the nine months ended September 30, 2025, we repurchased $2.60 billion of shares under our $15.00 billion share repurchase program authorized in December 2024. As of September 30, 2025, we had $12.40 billion remaining under this program.
During the nine months ended September 30, 2025, we paid dividends of $4.04 billion, or $4.50 per share, to our shareholders. In October 2025, we declared a dividend for the fourth quarter of 2025 of $1.50 per share of outstanding common stock. The dividend of approximately $1.34 billion is payable on December 10, 2025 to shareholders of record at the close of business on November 14, 2025.
Both domestically and abroad, we monitor the potential impacts of the economic environment and international tension and conflicts; the creditworthiness of our wholesalers and other customers, including foreign government-backed agencies and suppliers; the uncertain impact of healthcare legislation; various international government funding levels; and fluctuations in interest rates, foreign currency exchange rates (see "Executive Overview-Other Matters-Foreign Currency Exchange Rates"), and fair values of equity securities.
Our foreign currency risk exposure results from fluctuating currency exchange rates, primarily the U.S. dollar against the euro, Japanese yen, Chinese yuan and British pound sterling. We in some cases enter into foreign currency forward or option derivative contracts to reduce the effect of fluctuating currency exchange rates. As of September 30, 2025 and December 31, 2024, a hypothetical 10 percent change in currency exchange rates (primarily against the U.S. dollar) applied to the fair values of our outstanding foreign currency derivative contracts and the underlying assets and liabilities would not have a material impact on earnings, cash flows, or financial position over a one-year period.
CRITICAL ACCOUNTING ESTIMATES
For a discussion of our critical accounting estimates, refer to "Management's Discussion and Analysis of Results of Operations and Financial Condition" in Part II, Item 7 and the notes to our consolidated financial statements in Part II, Item 8 of our Annual Report on Form 10-Kfor the year ended December 31, 2024. See also Note 1 to the consolidated condensed financial statements. There have been no material changes to our critical accounting estimates since our Annual Report on Form 10-Kfor the year ended December 31, 2024.
AVAILABLE INFORMATION ON OUR WEBSITE
We make available through our company website, free of charge, our company filings with the Securities and Exchange Commission (SEC) as soon as reasonably practicable after we electronically file them with, or furnish them to, the SEC. The reports we make available include annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K, proxy statements, registration statements, and any amendments to those documents.
The website link to our SEC filings is investor.lilly.com/financial-information/sec-filings.
We routinely post important information for investors in the "Investors" section of our website, www.lilly.com. We may use our website as a means of disclosing material, non-public information and for complying with our disclosure obligations under Regulation FD. Accordingly, investors should monitor the "Investors" section of our website, in addition to following our press releases, filings with the SEC, public conference calls, presentations, and webcasts. We and our executive officers may also use social media channels to communicate with investors and the public about our business, products and other matters, and those communications could be deemed to be material information. The information contained on, or that may be accessed through, our website or our or our executive officers' social media channels, is not incorporated by reference into, and is not a part of, this Quarterly Report on Form 10-Q.