Eli Lilly (LLY) 10-K risk factor changes: FY2025 vs FY2024

[removed: -] 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.

Failure [added: or results that misalign with expectations] can occur at any point in the process, including in later stages after substantial [removed: investment and] [added: investment,] following meaningful cost for manufacturing capabilities and inventory to prepare for [removed: launch.][added: launch, and after we and others may have attributed significant value for these potential products.]

New product candidates that appear promising in development or prior to being acquired may fail to reach the market or may have only limited commercial success because of efficacy or safety concerns, inability to obtain or maintain necessary regulatory approvals or payer reimbursement or coverage, failure to obtain placement on guidelines or recommendations published by third-party [removed: organizations that are commensurate with clinical data,] [added: organizations,] the application of pricing controls, limited scope of approved uses, label changes, changes in the relevant treatment standards or the availability of newer, better, or more cost-effective competitive products, difficulty or excessive costs to manufacture, insufficient infrastructure to support detection, diagnostic or other requisites for treatment, ineffectiveness in connecting with healthcare professionals, including digitally through virtual engagements, or infringement of the patents or intellectual property rights of others.

In addition, it can be very difficult to predict revenue growth rates of, or variability in demand for, new or future products and indications, which in some cases leads to difficulty meeting product demand or, on the other hand, lower volume growth, excess [removed: inventory] [added: inventory,] and related financial charges.

Through internal innovation and business development we must maintain a flow of successful products and indications or line extensions sufficient both to cover our substantial research and development costs and investments and to replace revenues that are lost as profitable products become subject to pricing controls, lose intellectual property exclusivity, [removed: or] are displaced by competing [removed: products] [added: products,] or [removed: therapies.][added: therapies, or experience a reduction in patient access.]

Failure to [removed: timely] replenish our product portfolio and pipeline [added: in a timely manner] would have a material adverse effect on our business, results of operations, cash flows, and financial position.

We engage in various forms of business development activities to enhance or refine our product [removed: pipeline,] [added: pipeline and development capabilities,] including licensing arrangements, co-development agreements, co-promotion arrangements, distribution [added: and promotion agreements, joint ventures, acquisitions, equity investments, and divestitures.]

There are substantial risks associated with identifying [added: and competing for] successful business development targets and consummating related transactions.

Continued regulatory focus on business combinations in our industry, including by the Federal Trade Commission and competition authorities in Europe and other jurisdictions, and heightened competition for attractive targets has and could continue to delay, jeopardize, or increase the costs [added: or risks] of our business development activities.

In addition, failures or difficulties in integrating or retaining new personnel or the operations of the businesses, products, or assets we acquire (including related technology, commercial operations, compliance programs, information security, manufacturing, distribution, and general business operations and procedures) may affect our ability to realize the [removed: expected] [added: potential] benefits of business development transactions and may result in our incurrence of substantial asset impairment or restructuring charges.

We also may fail to generate the expected revenue and pipeline enhancement from business development activities due to [removed: limited] diligence [removed: opportunities,] [added: that fails to identify risks or adequately anticipate their magnitude,] unsuccessful clinical trials, issues related to the quality, integrity, or broad applicability of data, regulatory impediments, and manufacturing or commercialization challenges.

Additionally, business development activity focused on new modalities may entail additional risks and [removed: costs.][added: costs given the high levels of scientific uncertainty inherent in novel technologies.]

Business development transactions may not be completed in a timely manner (if at all), may not result in successful development outcomes or successful commercialization of any product, may [added: require additional unanticipated investments to achieve potential benefits, may] give rise to legal proceedings or regulatory scrutiny, and may result in charges that negatively impact our financial position or results of operations in any given period.

[removed: - We] [added: We] and our products face intense competition, [removed: including from multinational pharmaceutical companies, biotechnology companies,] and [removed: lower-cost generic and biosimilar manufacturers, and] such competition could have a material adverse effect on our business.

[removed: We compete with a large number of multinational pharmaceutical companies, biotechnology companies, and generic pharmaceutical companies and, in] [added: In] many cases, our products compete against the leading products of one or more of our competitors.

To compete [removed: successfully,] [added: successfully in a highly competitive and increasingly fast-paced global environment,] we must [removed: continue to] deliver innovative, cost-effective products through internal innovation or business development that meet important medical needs, provide improved outcomes and a positive consumer experience for patients, and deliver value to payers.

Our product revenues and prospects are adversely affected by patient access issues, the introduction by competitors of branded products that are first to market, have better marketplace access, have greater brand [removed: recognition] [added: recognition,] or are perceived as superior by the marketplace, by [added: price competition, by] generic or biosimilar versions of our branded products, and by generic or biosimilar versions of other products in the same therapeutic class as our branded products.

Particularly for biosimilars, health authority guidelines and legislative actions could [added: continue to] make it less burdensome for competitor products to enter the market and further incentivize uptake of biosimilars.

For example, we [removed: have seen an increase in] [added: continue to see] the production, marketing, and sale of counterfeit, misbranded, adulterated, and [removed: compounded] [added: mass-compounded] incretins [added: in the U.S. and other markets] that could materially impact us.

Our actions intended to stop or prevent illegal sales of such medicines [added: are costly and] may be [removed: costly or] ineffective.

See Item 1, "Business—Government Regulation of Our Operations and Products," for additional information on market risks related to counterfeit, misbranded, adulterated, and [removed: compounded] [added: mass-compounded] medicines.

[removed: commerce] [added: If inadequately regulated, e-commerce] may increase the prevalence of dangerous counterfeit or [removed: diverted] [added: mass-compounded] products and scams, potentially exposing patients to significant risks.

Our reputation and business could suffer harm as a result of counterfeit or [removed: diverted] [added: mass-compounded] drugs sold under our brand name, which may also impact our business and financial results.

In addition, we rely on our ability to [removed: attract, engage,] [added: attract] and retain highly qualified and skilled scientific, technical, management, and other personnel in order to compete effectively.

To [removed: continue to commercialize our products, and advance] [added: capitalize on] the [removed: research, development, and commercialization] [added: rapid development] of [removed: additional modalities, indications,] [added: next-generation technologies] and [removed: product candidates,] [added: otherwise effectively compete,] we [removed: have expanded, and will likely need] [added: must continue] to [removed: further expand,] [added: enhance skill sets and develop] our workforce, both in and outside the U.S. We [removed: continue to] face intense competition for qualified individuals from numerous multinational [removed: pharmaceutical] companies, [removed: biotechnology companies,] academic and other research institutions, as well as employers near our manufacturing and other facilities, which has [added: increased] and may continue to increase our labor costs.

Our failure to compete effectively for talent could negatively affect [removed: sales of] our [removed: current and any future approved products and indications,] [added: ability to discover, develop, manufacture,] and [removed: could result] [added: sell our medicines, resulting] in material financial, legal, commercial, or reputational harm to our business.

[removed: -] Our business is subject to [removed: increasing] 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, [removed: reputation] [added: reputation,] or business.

Public and private [removed: payers] [added: actors] continue to take aggressive steps to control [removed: their] expenditures for pharmaceuticals by placing restrictions on pricing and reimbursement for, and patient access to, our medicines.

These pressures have negatively [removed: affected,] [added: affected] and we expect will continue to negatively [removed: affect,] [added: affect] our consolidated results of operations.

Governments and private [removed: payers] [added: actors] worldwide [removed: have intensified their scrutiny of, and actions intended to address, pricing, reimbursement, and access to pharmaceutical products and] are demanding greater commercial and clinical value from pharmaceutical companies in the form of strong product differentiation and demonstrated value.

We continue to experience scrutiny on the pricing of current and potential [removed: diabetes, obesity, and Alzheimer's disease] products due [removed: to] [added: to, among other factors,] payer concern over projected growth in [removed: these markets] [added: demand] and, for certain of these drugs, the anticipated duration of treatment.

Additional policies, regulations, legislation, or enforcement, including because of the regulatory priorities of the U.S. executive [removed: branch] [added: branch, state attorneys general,] and regulatory authorities worldwide, could adversely impact our business and consolidated results of operations.

For example, 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 in Medicare [removed: effective] [added: (effective beginning] in [removed: 2026.][added: 2026) at a significant discount compared to the list price.]

The effect of reducing prices and reimbursement for certain of our products [removed: could significantly impact] [added: impacts] our business and consolidated results of operations.

Within the U.S., state level transparency initiatives, importation rules, reporting requirements, and mandated programs, including the establishment of drug affordability boards with the power to set upper payment limits on certain [removed: drugs in state-regulated plans,] [added: drugs,] have also increased administrative costs, in some cases, compromised confidential business practices and otherwise detrimentally impacted our business.

For more details, see Item 1, "Business—Regulations and Private Payer Actions Affecting Pharmaceutical Pricing, Reimbursement, and [removed: Access."][added: Access," Item 7, "Management's Discussion and Analysis—Executive Overview—Other Matters—Trends Affecting Pharmaceutical Pricing, Reimbursement, and Access and Certain Other Regulatory Developments," and Item 8, "Financial Statements and Supplementary Data—Note 16: Contingencies."]

Further, restrictive or unfavorable pricing, coverage, or reimbursement determinations for our medicines or product candidates by governments, regulatory agencies, courts, or private [removed: payers,] [added: actors,] including in relation to the [removed: implementation of the] IRA, reference pricing, [removed: and] [added: or] compulsory licensing, may adversely impact our business and financial results.

Calculation methodologies are inherently subjective and [removed: are] subject to review and challenge by government [removed: agencies.][added: agencies and, in some cases, by private actors.]

If [removed: agencies disagree] [added: there is disagreement] with our calculations, or the methodologies and assumptions underlying them, we may need to restate previously reported data and could be subject to financial and legal liability, which may be significant.

[removed: - Pharmaceutical] [added: Pharmaceutical] products can develop safety or efficacy concerns, which could have a material adverse effect on our revenues, income, and reputation.

We regularly submit new product candidates and indications to regulatory agencies for approval, including highly anticipated candidates such as orforglipron.

We compete with a large number of multinational pharmaceutical companies, biotechnology companies, and generic pharmaceutical companies and face intensifying competition worldwide, including from China and other markets where research and development capabilities have expanded and accelerated significantly.

Technological innovation has amplified and we expect will continue to amplify competitive aspects of our business, including by enabling additional participation in and breadth of drug discovery and new healthcare delivery models.

Business practices or commercial capabilities that we deploy in light of these or other market dynamics may not prove sufficient.

In addition to patient safety concerns, improper commercialization and dispensation practices by these actors may inappropriately condition consumer expectations or otherwise disadvantage compliant market participants.

In November 2025, we announced preliminary voluntary agreements with the U.S. government in which, among other arrangements, we agreed to implement measures to lower Medicaid and certain other drug prices for U.S. patients and to launch new medicines with a more balanced pricing approach across developed nations.

We face risks and uncertainty associated with these arrangements and negotiating the definitive agreements, including potential delays and the possibility of unfavorable terms related to pricing, access, and other key objectives.

Among other risks, we may fail to adequately capitalize on the additional U.S. access to our obesity medicines resulting from these agreements, particularly if the revenues generated from such expanded access are insufficient to offset pricing concessions.

Moreover, the outcome of these arrangements and broader U.S. policy efforts to align domestic pharmaceutical pricing with international benchmarks from countries with competing healthcare cost containment priorities is uncertain and could negatively impact our pricing strategies, product demand or access, or competitive positioning across global markets, and may result in reduced revenue in certain markets.

In general, securing and growing access for our obesity medicines is an important factor in the success of our business.

Among other considerations, payers in various international markets do not currently provide coverage for obesity medicines for weight loss indications, requiring patient self-pay.

In addition, patient self-pay sales through LillyDirect represented a growing portion of our business in 2025, and we have launched, and continue to explore, new partnerships and tools, including through LillyDirect, to further expand access to our medicines.

Our financial results and prospects are subject to risks related to the level and pace of patient participation in cash-pay markets, which may be influenced by pricing, economic conditions, and competitive offerings, as well as regulatory or other actions that could restrict our ability to benefit from such markets, and uncertainty regarding our ability to secure reimbursement coverage in such markets over time.

In January 2026, HHS selected Trulicity and Verzenio as additional medicines subject to government-set prices to be effective in 2028.

Continued expansion of the 340B program and growth of entities claiming entitlement to 340B pricing, including in ways that may be inconsistent with the statutory scheme and through state laws that purport to mandate 340B sales to contract pharmacies, impact our revenue on an increasing percentage of sales.

Changes to the calculation of rebates under the Medicaid program could also increase our Medicaid rebate obligations and decrease the prices charged to 340B covered entities, which could have a significant impact on our business.

For example, in July 2025, CVS Caremark, the pharmacy benefit management division of CVS Health, stopped covering Zepbound as a preferred obesity management medicine on some insurance plans, which has negatively impacted access for patients covered under these plans.

Patent expirations of competitive products may also shift market conditions for our products by contracting the market for branded products, impacting product access, or otherwise intensifying pricing pressures across similar treatments.

The USPTO issued procedures regarding the discretionary denial by the Director of institution of IPR proceedings based on the agency's workload and priorities.

The USPTO's ability to apply these

procedures is being challenged, and it is not clear how these procedures will affect the ability of our competitors to institute IPR proceedings.

Intellectual property threats across international markets include policies which favor domestic competitors or are otherwise disadvantageous to our products, challenges to our patents’ validity in foreign courts, and government policies that force technology transfer or undermine or nullify patent protections under the guise of health emergencies or other public interests.

Breaches

Third-party access to our proprietary data may also enable such party's development of competing products or enhancement of services sold to competitors, thereby eroding our competitive advantage.

We continue to implement measures in an effort to protect, detect, respond to, remediate, and minimize or prevent these

Supply chain difficulties, disruptions or shortages may arise from our or contracted supply chain activity as well as from external environmental factors.

Variability in demand and supply for our products can also challenge supply capacity and resiliency.

Relevant external environmental factors include (i) tariffs, (ii) cost inflation and global transportation and logistics challenges; (iii) labor market dynamics; (iv) natural disasters (including increased instances or severity of natural disasters or other events that may be due to climate change); (v) public health outbreaks, epidemics, or pandemics; (vi) periods of uneven economic growth or downturns; and (vii) the emergence or escalation of, or responses to international tension and conflicts.

future demand will be realized as expected or that we will meet demand in launched markets in the future.

In addition, historically, geopolitical tensions between the U.S. and China have led to the imposition of tariffs, sanctions, and certain other business restrictions between the U.S. and China.

Tariffs have been imposed or proposed on a variety of other geographies in which we have third-party suppliers.

We have also entered into, and may continue to enter into, partnerships and collaborations relating to the use of AI technology to aid in drug discovery and other efforts.

analyses, or recommendations we utilize could be inadequate, or that our competitors may more quickly or effectively adopt AI capabilities.

There are significant risks involved in developing and deploying AI, and there can be no assurance that our usage of AI or our significant investments in AI will enhance our products or services or be beneficial to our business, including our efficiency or profitability.

AI may enable new competitors in drug discovery and enhance the capabilities of existing competitors, thereby broadening and intensifying competitive dynamics.

Our global operations and complex supply chain expose us to legislation and regulatory action in or regarding foreign jurisdictions as well as geopolitical and other cross-border risks.

In 2025, the U.S. and other countries 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 may depend on their ultimate scope, timing, and other factors.

and promotion agreements, joint ventures, acquisitions, equity investments, and divestitures.

If inadequately regulated, e-

In August 2024, HHS announced the government-set prices for these first ten medicines with Jardiance subject to a 66% discount compared to the 2023 U.S. calendar year list price for a 30-day supply and discounts for the other nine medicines ranging from approximately 38% to 79% below list price.

Certain states have also undertaken efforts to codify 340B contract pharmacies into statute or impose other state law mandates, which increase the cost of 340B programs.

To date, several states have passed contract pharmacy legislation, which have been subject to various legal challenges.

For more details, see Item 1, "Business—Regulations and Private Payer Actions Affecting Pharmaceutical Pricing, Reimbursement, and Access," Item 7, "Management's Discussion and Analysis—Executive Overview—Other Matters—Trends Affecting Pharmaceutical Pricing, Reimbursement, and Access and Certain Other Regulatory Developments" and Item 8, "Financial Statements and Supplementary Data—Note 16: Contingencies."

The USPTO issued an interim procedure regarding the use of discretionary denials of IPR proceedings when there is parallel district court litigation.

However, it is not clear how this interim procedure could affect the ability of our competitors to institute IPR proceedings after institution of litigation.

The failure, inadequacy, or breach of our IT systems or business processes or controls or procedures, the compromise, disruption, degradation, manipulation, loss, theft, exfiltration, destruction, or unauthorized access to, disclosure or use of, confidential information, or the unauthorized access to, disruption of, or interference with our products and services that rely on IT systems or business processes, could impair

Further, cost inflation and global transportation and logistics

For example, at various times during 2024 demand for our incretin medicines exceeded production.

While tirzepatide supply currently exceeds demand in the U.S., demand remains dynamic and could be impacted by a variety of factors.

Supply considerations will continue to influence the timing and approach (including available presentations) of tirzepatide launches in new markets.

Additionally, tariffs were proposed or threatened with respect to other jurisdictions, including Mexico, Canada and Europe.

If geopolitical tensions were to increase and disrupt our operations in, or related to, China or other major international geographies, such disruption would significantly impact our business.

In recent periods, significant fluctuations in currency rates and inflation have impacted our results of operations.

In addition, regulatory issues and evolving standards concerning compliance with cGMP and quality assurance, including increased scrutiny

In addition, changing political leadership, including the new presidential administration and regulatory leadership in the U.S., may propose, enact, or pursue policy, regulatory, and enforcement changes that create additional uncertainty for our business.

(Tables present dollars in millions, except per-share [removed: data)][added: data, and numbers may not add due to rounding)]

| Earnings per share - diluted | | | [removed: 11.71] [added: 22.95] | | | | | | [removed: 5.80] [added: 11.71] | | | | | | [removed: 102] [added: 96] | | |

Net income and earnings per share increased in [removed: 2024,] [added: 2025,] primarily due to higher gross margin, partially offset by increased [removed: research and development expenses,] marketing, selling, and administrative [removed: expenses,] [added: expenses] and [removed: asset impairment, restructuring,] [added: research] and [removed: other special charges.][added: development expenses.]

The following select new molecular entities (NMEs) and new indication line extension (NILEX) products are currently in [removed: Phase 2 or Phase 3] clinical trials or have been submitted for regulatory review or have recently received regulatory approval in the [removed: United States (U.S.),] [added: U.S.,] European Union (EU), or Japan.

The table reflects the status of these NMEs and NILEX products, [removed: including certain other developments,] up to the time of the filing of this Annual Report on Form 10-K:

| [added: Tirzepatide (Mounjaro, Zepbound) | | |] Heart failure with preserved ejection fraction | | | [removed: Submitted] [added: Approved] | | | [removed: Submitted] [added: Approved] in the [removed: U.S. and the EU in 2024. | | |] [added: EU.] | | | | | |

| Cardiovascular outcomes [removed: in type 2 diabetes] | | | Phase 3 | | | Phase 3 trial [removed: is ongoing.] [added: was initiated.] | | | | | | | | |

| [removed: Higher doses] [added: CRSwNP] | | | Phase [removed: 2] [added: 3] | | | Phase [removed: 2] [added: 3] trial is ongoing. | | | | | | | | |

| Lepodisiran | | | Atherosclerotic cardiovascular disease | | | Phase 3 | | | Phase 3 trial [removed: initiated in 2024.] [added: is ongoing.] | | | | | |

| [removed: Orforglipron | | | Obesity] [added: Obstructive Sleep Apnea (OSA)] | | | Phase 3 | | | Phase 3 trials are ongoing. | | | | | | [added: | | |]

| Retatrutide | | | Cardiovascular / renal outcomes | | | Phase 3 | | | Phase 3 trials [removed: initiated in 2024.] [added: are ongoing.] | | | | | |

| Obesity, osteoarthritis, OSA | | | Phase 3 | | | Phase 3 [added: trial met all primary and key secondary endpoints. Phase 3] trials are ongoing. | | | | | | | | |

| Type [removed: 2] [added: 1] diabetes | | | Phase 3 | | | Phase 3 trials [removed: initiated in 2024.] [added: were initiated.] | | | | | | | | |

| Eloralintide | | | Obesity | | | Phase [removed: 2] [added: 3] | | | Phase [removed: 2] [added: 3] trial [removed: initiated in 2024.] [added: was initiated.] | | | | | |

| [removed: Solbinsiran] [added: Muvalaplin] | | | [removed: Cardiovascular] [added: Atherosclerotic cardiovascular] disease | | | Phase [removed: 2] [added: 3] | | | Phase [removed: 2] [added: 3] trial [removed: is ongoing.] [added: was initiated.] | | | | | |

| Mirikizumab (Omvoh) | | | Crohn's disease | | | Approved | | | Approved in the [removed: U.S. and] [added: U.S.,] the [removed: EU in 2025. Submitted in Japan in 2024.] [added: EU, and Japan.] | | | | | |

| [removed: Lebrikizumab(1)] [added: Lebrikizumab(2)] | | | AR (perennial allergens) | | | Phase 3 | | | Phase 3 trial [removed: initiated in 2024.] [added: is ongoing.] | | | | | |

| Donanemab (Kisunla) | | | Early Alzheimer's disease | | | Approved | | | Approved in the [removed: U.S. and Japan in 2024. Submitted in] [added: U.S.,] the [removed: EU in 2023. Phase 3 trials are ongoing.] [added: EU, and Japan.] | | | | | |

| Remternetug | | | [removed: Early] [added: Pre-clinical/MCI] Alzheimer's disease | | | Phase 3 | | | Phase 3 trials are ongoing. | | | | | |

| Pirtobrutinib (Jaypirca) | | | Chronic lymphocytic leukemia | | | [removed: Approved(3)] [added: Approved] | | | [removed: FDA granted accelerated approval(3)] [added: Full approval] in the [removed: U.S. in 2023. Submitted in] [added: U.S.,] the [removed: EU] [added: EU,] and [removed: Japan in 2024. Phase 3 trials are ongoing.] [added: Japan.] | | | | | |

| Imlunestrant [added: (Inluriyo)] | | | [removed: ER+HER2-] [added: ER+, HER2-, ESR1-mutated advanced or] metastatic breast cancer | | | [removed: Submitted] [added: Approved] | | | [removed: Submitted] [added: Approved] in the U.S., the EU, and [removed: Japan in 2024.] [added: Japan.] | | | | | |

| [removed: Olomorasib] [added: Olomorasib(3)] | | | 1L KRAS G12C+ NSCLC | | | Phase 3 | | | Phase 3 trial [removed: initiated in 2024.] [added: is ongoing.] | | | | | |

[removed: (1)] [added: (2)] In collaboration with Almirall, S.A. in Europe.

Reforms, [added: 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, [added: 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 [removed: pricing] [added: cost, pricing, reimbursement,] and [removed: reimbursement] [added: access] for our products.

Global concern over access to, and affordability of, pharmaceutical products continues to drive [removed: regulatory and legislative] debate and action, as well as cost containment efforts by governmental [removed: authorities.][added: authorities and scrutiny of pricing and access disparities.]

[removed: Such] [added: 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.

[removed: Among other measures, the] [added: The] IRA requires [removed: the U.S. Department of Health and Human Services (HHS)] [added: HHS] to effectively set prices for certain single-source drugs and biologics reimbursed under Medicare Part B and Part D.

[removed: Generally,] [added: Currently,] these government prices [added: 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 [removed: molecule and are set at a price that generally represents a significant discount from existing prices to wholesalers and direct purchasers.][added: molecule.]

Given our product portfolio, we expect [removed: additional] [added: other] significant products will be selected in future [removed: years, which would have the effect of accelerating revenue erosion prior to expiry of exclusivities.][added: years.]

The IRA has, and will continue to, meaningfully influence our business strategies and those of our [removed: competitors.][added: competitors and could significantly impact our business and consolidated results of operations.]

[removed: Additional] [added: Other] policies, regulations, legislation, or enforcement, including those proposed or pursued by lawmakers, regulators, and other authorities in the U.S. and worldwide, [removed: could] [added: have and may continue to] adversely impact our business and consolidated results of operations.

[removed: Consolidation and integration of private] [added: Private] payers and pharmacy benefit managers in the U.S. [removed: has also] [added: continue to] significantly [removed: impacted] [added: impact] the market for pharmaceuticals [removed: by increasing payer leverage in negotiating] [added: through negotiation of access,] manufacturer price or rebate concessions and pharmacy reimbursement rates.

[removed: Furthermore, restrictive] [added: Restrictive] or unfavorable pricing, coverage, or reimbursement determinations for our medicines or product candidates by governments, regulatory agencies, courts, or private [removed: payers] [added: actors have and] may [added: continue to] adversely impact our business and consolidated results of operations.

[removed: Production increases will continue, and additional] [added: Additional] capacity is expected to [removed: be] [added: become] operational over the next several years.

We [removed: have seen an increase in] [added: continue to see] the production, marketing, and sale of counterfeit, misbranded, adulterated, and [removed: compounded] [added: mass-compounded] incretins.

Further, actions taken with respect to tax-related matters by associations such as the [removed: Organisation for Economic Co-operation and Development (OECD)] [added: OECD] and the European Commission could influence tax laws in countries in which we operate.

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 [added: on] our future consolidated results of operations and cash flows.

See Note [removed: 3] [added: 4] to the consolidated financial statements for [removed: further discussion regarding our recent acquisitions.][added: additional information.]

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, [removed: and] Chinese [removed: yuan.][added: yuan, and British pound sterling.]

These factors include cost and wage inflation, supply chain and labor market complexities, international tension and conflicts, uneven economic [removed: growth or] [added: growth,] downturns or uncertainty, [added: risks related to engaging in business globally, including legislation] and [removed: an increase] [added: regulatory action] in [removed: overall] [added: or regarding foreign jurisdictions, and fluctuations due to channel dynamics or] demand [removed: in our industry] for certain [removed: products and materials.][added: products.]

| | | | 2025 | | | | | | 2024 | | | | | | | | |

| Revenue | | | $ | 65,179 | | | | | $ | 45,043 | | | | | 45 | | |

| Net income | | | 20,640 | | | | | | 10,590 | | | | | | 95 | | |

Revenue increased in 2025 driven primarily by increased volume, partially offset by lower realized prices.

The increased volume and lower realized prices in 2025 were primarily driven by Mounjaro and Zepbound.

| Pediatric and adolescent type 2 diabetes | | | Approved | | | Approved in the U.S. and the EU. | | | | | | | | |

| Cardiovascular outcomes in type 2 diabetes | | | Submitted | | | Submitted in the U.S. | | | | | | | | |

| Metabolic dysfunction-associated steatotic liver disease | | | Phase 3 | | | Phase 3 trial was initiated. | | | | | | | | |

| Insulin efsitora alfa | | | Type 2 diabetes | | | Submitted | | | Submitted in the U.S., the EU, and Japan. | | | | | |

| Orforglipron | | | Obesity(1) | | | Submitted | | | Submitted in the U.S., the EU, and Japan. | | | | | |

| Type 2 diabetes | | | Submitted | | | Submitted in the EU. Phase 3 trials are ongoing. | | | | | | | | |

| Hypertension | | | Phase 3 | | | Phase 3 trial was initiated. | | | | | | | | |

| Osteoarthritis pain | | | Phase 3 | | | Phase 3 trial was initiated. | | | | | | | | |

| Peripheral artery disease | | | Phase 3 | | | Phase 3 trial was initiated. | | | | | | | | |

| Stress urinary incontinence | | | Phase 3 | | | Phase 3 trial was initiated. | | | | | | | | |

| Chronic low back pain | | | Phase 3 | | | Phase 3 trial was initiated. | | | | | | | | |

| Metabolic dysfunction-associated steatotic liver disease | | | Phase 3 | | | Phase 3 trial was initiated. | | | | | | | | |

| Brenipatide | | | Alcohol use disorder | | | Phase 3 | | | Phase 3 trial was initiated. | | | | | |

| Ixo-vec | | | Wet age‑related macular degeneration | | | Phase 3 | | | Acquired in the acquisition of Adverum Biotechnologies, Inc. Phase 3 trial is ongoing. | | | | | |

| Resected adjuvant NSCLC | | | Phase 3 | | | Phase 3 trial was initiated. | | | | | | | | |

| Unresected adjuvant NSCLC | | | Phase 3 | | | Phase 3 trial was initiated. | | | | | | | | |

| Sofetabart mipitecan (FRα ADC)(3) | | | Platinum-resistant ovarian cancer | | | Phase 3 | | | Phase 3 trial was initiated. | | | | | |

(1) Granted a Commissioner's National Priority Voucher from the FDA.

(3) The FDA granted Breakthrough Therapy designation for olomorasib for the treatment of certain newly diagnosed metastatic KRAS G12C-mutant lung cancers and for sofetabart mipitecan for the treatment of certain patients with platinum-resistant ovarian cancer.

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.

In November 2025, we announced preliminary voluntary agreements with the U.S. government in which, among other arrangements, we agreed to lower Medicaid and certain other drug prices for U.S. patients and to launch new medicines with a more balanced pricing approach across developed nations.

We face risks and uncertainty associated with these arrangements and negotiating the definitive agreements, including potential delays and the possibility of unfavorable terms related to pricing, access, and other key objectives.

Among other risks, we may fail to adequately capitalize on the additional U.S. access to our obesity medicines resulting from these agreements, particularly if the revenues generated from such expanded access are insufficient to offset pricing concessions.

Moreover, the outcome of these arrangements and broader U.S. policy efforts to align domestic pharmaceutical pricing with international benchmarks from countries with competing healthcare cost containment priorities is uncertain and could negatively impact our pricing strategies, product demand or access, or competitive positioning across global markets, and may result in reduced revenue in certain markets.

In January 2026, HHS selected Trulicity and Verzenio as additional medicines subject to government-set prices to be effective in 2028.

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.

Mounjaro and Zepbound accounted for 56 percent of our total revenues in 2025 and we expect cardiometabolic health products will continue to represent a significant and growing portion of our business, revenues, and prospects.

In 2025, we reached preliminary drug pricing agreements with the U.S. government.

As part of these agreements, Medicare beneficiaries will have access to discounted Lilly obesity medicines by July 1, 2026 and individual state Medicaid programs will have the option to expand access to these medicines.

Also in 2025, we received a U.S. Commissioner’s National Priority Voucher for our product candidate orforglipron for the treatment of obesity, and we submitted to the FDA under that expedited review pathway.

| | | | 2024 | | | | | | 2023 | | | | | | | | |

| Revenue | | | $ | 45,042.7 | | | | | $ | 34,124.1 | | | | | 32 | | |

| Net income | | | 10,590.0 | | | | | | 5,240.4 | | | | | | 102 | | |

Revenue increased in 2024 driven by increased volume and, to a lesser extent, higher realized prices.

The increase in revenue in 2024 was primarily driven by Mounjaro, Zepbound, and Verzenio, partially offset by Trulicity.

We currently have approximately 55 new medicine candidates in clinical development or under regulatory review, and a larger number of projects in the discovery phase.

| | | | | | | | | | | | | | | |

| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |

| Compound | | | Indication/Study | | | Status | | | Developments | | | | | |

| Tirzepatide (Mounjaro, Zepbound) | | | Obesity | | | Approved | | | Approved in the U.S. and the EU in 2023 and in Japan in 2024. Phase 3 trials are ongoing. | | | | | |

| Obstructive sleep apnea (OSA) | | | Approved | | | Approved in the U.S. and the EU in 2024. | | | | | | | | |

| Metabolic dysfunction-associated steatohepatitis | | | Phase 2 | | | Announced in 2024 that a Phase 2 trial met the primary endpoint. | | | | | | | | |

| Insulin Efsitora Alfa | | | Type 1 and type 2 diabetes | | | Phase 3 | | | Announced in 2024 that five Phase 3 trials met the primary endpoints. | | | | | |

| OSA | | | Phase 3 | | | Phase 3 trials initiated in 2024. | | | | | | | | |

| Bimagrumab | | | Obesity | | | Phase 2 | | | Phase 2 trial is ongoing. | | | | | |

| GLP-1R NPA II | | | Obesity | | | Phase 2 | | | Phase 2 trial initiated in 2024. | | | | | |

| Mazdutide | | | Obesity | | | Phase 2 | | | Phase 2 trial is ongoing. | | | | | |

| Muvalaplin | | | Cardiovascular disease | | | Phase 2 | | | Announced in 2024 that a Phase 2 trial met the primary and secondary endpoints. | | | | | |

| Volenrelaxin | | | Heart failure | | | Discontinued | | | In 2025, Phase 2 trial was discontinued based on clinical data readout. | | | | | |

| CRSwNP | | | Phase 3 | | | Phase 3 trial initiated in 2024. | | | | | | | | |

| CD19 Antibody | | | Multiple sclerosis | | | Phase 2 | | | Phase 2 trial initiated in 2024. | | | | | |

| Eltrekibart | | | Hidradenitis suppurativa | | | Phase 2 | | | Phase 2 trial is ongoing. | | | | | |

| Ulcerative colitis | | | Phase 2 | | | Phase 2 trial initiated in 2024. | | | | | | | | |

| KV1.3 Antagonist | | | Psoriasis | | | Phase 2 | | | Phase 2 trial initiated in 2024. | | | | | |

| MORF-057 | | | Crohn's disease | | | Phase 2 | | | Acquired in the acquisition of Morphic Holding, Inc. (Morphic) in 2024. Phase 2 trials are ongoing. | | | | | |

| Ulcerative colitis | | | Phase 2 | | | | | | | | | | | |

| Ocadusertib | | | Rheumatoid arthritis | | | Phase 2 | | | Phase 2 trial is ongoing. | | | | | |

| Simepdekinra (DC-853) | | | Psoriasis | | | Phase 2 | | | Phase 2 trial initiated in 2024. | | | | | |

| Ucenprubart | | | Atopic dermatitis | | | Discontinued | | | In 2024, Phase 2 trial was discontinued based on clinical data readout. | | | | | |

| Epiregulin Ab | | | Pain | | | Phase 2 | | | Phase 2 trial initiated in 2024. | | | | | |

| GBA1 Gene Therapy | | | Gaucher disease Type 1 | | | Phase 2 | | | Phase 2 trial is ongoing. | | | | | |

| Parkinson's disease | | | Phase 2 | | | Granted U.S. Food and Drug Administration (FDA) Fast Track designation(2). Phase 2 trial is ongoing. | | | | | | | | |

| GRN Gene Therapy | | | Frontotemporal dementia | | | Phase 2 | | | Granted FDA Fast Track designation(2). Phase 2 trial is ongoing. | | | | | |

| Mazisotine | | | Pain | | | Phase 2 | | | Phase 2 trials are ongoing. | | | | | |

| OTOF Gene Therapy | | | Hearing loss | | | Phase 2 | | | Phase 2 trial initiated in 2024. | | | | | |

| P2X7 Inhibitor | | | Pain | | | Phase 2 | | | Phase 2 trials were completed in 2023. | | | | | |

| O-GlcNAcase Inh | | | Alzheimer's disease | | | Discontinued | | | In 2024, Phase 2 trial was discontinued based on clinical data readout. | | | | | |

| Mantle cell lymphoma | | | Approved(3) | | | FDA granted accelerated approval(3) in the U.S. in 2023. Approved in the EU in 2023 and in Japan in 2024. Phase 3 trial is ongoing. | | | | | | | | |

(2) Fast Track designation is designed to facilitate the development and expedite the review of medicines to treat serious conditions and fill an unmet medical need.

(3) Continued approval may be contingent on verification and description of clinical benefit in confirmatory Phase 3 trials.

Our products are sold in approximately [removed: 95] [added: 90] countries.

| *Jaypirca* | | | For the treatment of adult patients with relapsed or refractory [removed: mantle cell] [added: chronic lymphocytic leukemia or small lymphocytic] lymphoma [removed: (MCL) after at least two lines of systemic therapy, including] [added: (CLL/SLL) who have previously been treated with] a [added: covalent] BTK inhibitor; and for the treatment of adult patients with [removed: chronic lymphocytic leukemia] [added: relapsed] or [removed: small lymphocytic] [added: refractory mantle cell] lymphoma [removed: who have received] [added: (MCL) after] at least two [removed: prior] lines of [added: systemic] therapy, including a BTK [removed: inhibitor and a BCL-2] inhibitor. | | | | | |

[removed: We] [added: As applicable, we] educate healthcare providers about our products in various ways, including [removed: promoting] [added: via promotion] in online [added: and other] channels, distributing [removed: literature] [added: information] and samples of certain products to physicians, and exhibiting at medical meetings.

Our account managers service wholesalers, pharmacy benefit managers, [added: insurers, plan sponsors, employers,] managed care organizations, group purchasing organizations, government and long-term care institutions, hospitals, and certain retail pharmacies.

[removed: We enter into] [added: Our] arrangements with these organizations [removed: to provide] [added: often include] discounts or rebates on our products.

In [added: 2025,] 2024, [removed: 2023,] and [removed: 2022,] [added: 2023,] three wholesale distributors in the U.S.—McKesson Corporation, Cencora, Inc., and Cardinal Health, Inc.—each accounted for a significant percentage of our consolidated revenue.

[removed: We] [added: Sales through LillyDirect represented a growing portion of our business in 2025 and we] have launched, and continue to explore, new partnerships and tools, including through LillyDirect, to [added: further] expand access to our medicines.

See, for examples, Item 1A, "Risk Factors—Risks 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 [removed: each] result in material harm to our [added: business and reputation" and "Risk Factors—Risks Related to Litigation and Government Regulation—Regulatory compliance problems could be damaging to the company."]

The products we market and their distribution vary from country to [removed: country.][added: country depending on the market and applicable regulations.]

For additional information, see Item 8, "Financial Statements and Supplementary Data—Note [removed: 4:] [added: 3:] Collaborations and Other Arrangements."

Important competitive factors include effectiveness, safety, availability, ease of use, [added: patient preference,] and overall [removed: patient] experience; formulary placement, price, payer coverage and reimbursement rates, and demonstrated cost-effectiveness; regulatory approvals; marketing effectiveness; and research and development of new products, processes, modalities, indications, and uses.

[removed: Self-insured] [added: For example, in the U.S. self-insured] employers must [added: generally] opt in for coverage of [removed: these] [added: anti-obesity] medicines.

[removed: Medicare and payers] [added: Payers] in various international markets also [removed: have] [added: do] not [removed: covered] [added: cover] anti-obesity medicines for weight loss.

Our anti-obesity medicines comprise a significant portion of our revenues, and barriers to reimbursable patient access [removed: may] impact our sales volumes, business, and results of operations.

We believe our long-term competitive success depends on discovering and developing or acquiring [added: and further developing] innovative, cost-effective products that provide improved outcomes for patients and deliver value to payers, and continuously improving the productivity of our operations in a highly competitive [added: and global] environment.

As a result, generic manufacturers generally invest far fewer resources [added: in research and development] than we do for our branded products [removed: in research] and [removed: development and] can price their products significantly lower than [removed: our] branded products.

[removed: Regulatory interpretation of important aspects of the laws regulating biosimilars continues to evolve, and therefore the] [added: The] impact of these laws [added: and guidance] on our business remains subject to substantial uncertainty.

[removed: In recent periods, we have seen an increase in] [added: We continue to see] the production, marketing, and sale of counterfeit, misbranded, adulterated, and [removed: compounded incretins.][added: mass-compounded incretins in the U.S. and other markets.]

See [removed: Item 1, "Business—Government] [added: "—Government] Regulation of Our Operations and Products," for additional information on market risks related to counterfeit, misbranded, adulterated, and [removed: compounded] [added: mass-compounded] medicines.

In the U.S. private sector, [removed: consolidation] [added: consolidated] and [removed: integration among] [added: integrated] healthcare organizations significantly [removed: affects] [added: affect] the competitive marketplace for pharmaceuticals.

[removed: Formulary] [added: Unfavorable formulary] placement can lead to reduced usage of a product for the relevant patient population due to coverage restrictions, such as prior authorizations and formulary exclusions, or due to reimbursement limitations that result in higher consumer out-of-pocket cost, such as non-preferred co-pay tiers, increased co-insurance levels, and higher deductibles.

As payers and pharmaceutical companies continue to negotiate formulary placement and rebates, value-based agreements, where rebates may be based on achievement (or not) of specified outcomes, are another [removed: increasingly] prevalent tool.

Rebates and net cost are [removed: increasingly] important factors in formulary decisions, particularly in treatment areas in which the payer has taken the position that multiple branded products are therapeutically comparable.

Loss of effective patent protection for [removed: pharmaceuticals, especially for non-biologic products, typically results] [added: pharmaceuticals can result] in the loss of effective market exclusivity for the product, often leading to a severe and rapid decline in revenues for the product.

- Patent term [removed: restoration] [added: extension] for a single patent for a pharmaceutical product is provided to U.S. patent holders to compensate for a portion of the time invested in clinical trials and the [removed: U.S. Food and Drug Administration (FDA)] [added: FDA] review process.

In some cases, the innovator company may retain exclusivity despite approval of the generic, biosimilar, or other follow-on versions of a new medicine beyond the expiration of the compound patent through market dynamics and challenges, later-expiring patents [removed: on] [added: on, for example,] manufacturing processes, methods of use or formulations, or data protection that may be available under pharmaceutical regulatory laws.

If granted, this "pediatric exclusivity" provides an additional six months of exclusivity, which is added to the [removed: term] [added: end] of [removed: data protection, orphan drug] [added: any other unexpired] exclusivity and, for products other than biologics, [removed: pediatric exclusivity is also added] to the [removed: term] [added: end] of [removed: any relevant and non-expired] [added: certain unexpired] patents.

The [removed: most] relevant patent protection or data protection and associated expiry dates for our major or recently launched patent-protected marketed products are as follows:

| Cardiometabolic Health products | | | [removed: Jardiance] [added: Jardiance*] | | | compound patent | | | [removed: U.S.*] [added: U.S.] | | | 2029 | | |

| data protection | | | major European countries | | | [removed: 2024] [added: 2035] | | | | | | | | |

| [added: Oncology products | | |] Retevmo | | | compound patent | | | U.S. | | | [removed: 2037 | | |] [added: 2038] | | |

| major European countries | | | [removed: 2024] [added: 2039] | | | | | | | | | | | |

| [removed: Reyvow] [added: Inluriyo] | | | compound patent | | | U.S. | | | [removed: 2028] [added: 2039] | | | | | |

| [removed: data protection | | |] major European countries | | | [removed: 2032] [added: 2036] | | | | | | | | | [added: | | |]

[removed: *] [added: In the U.S.,] Jardiance [removed: and] [added: includes] the related combination product, Glyxambi.

- [removed: Donanemab] [added: Insulin efsitora alfa] has been submitted for regulatory review in the [removed: EU] [added: U.S., the EU, and Japan] for the treatment of [removed: early Alzheimer's disease.][added: type 2 diabetes.]

For information on our license and collaboration agreements, see Item 8, "Financial Statements and Supplementary Data—Note [removed: 4:] [added: 3:] Collaborations and Other Arrangements."

However, after the innovator has marketed its product for four years, a generic manufacturer may file an ANDA alleging that the patent(s) listed in the innovator's New Drug Application (NDA) are invalid, [removed: unenforceable] [added: unenforceable,] or not infringed.

In addition, generic companies have shown willingness to launch "at [removed: risk," i.e.,] [added: risk" (i.e.,] after receiving ANDA [removed: approval] [added: approval)] but before final resolution of their patent challenge.

For more information on patent challenges and litigation involving our intellectual property rights, see Item 1A, "Risk Factors—Risks Related to Our [removed: Business—Our] [added: 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" and Item 8, "Financial Statements and Supplementary Data—Note 16: Contingencies."

| *Inluriyo* | | | For the treatment of adults with ER-positive HER2-negative, ESR1-mutated advanced or metastatic breast cancer whose disease progressed after at least one line of endocrine therapy. | | | | | |

In certain jurisdictions, we utilize LillyDirect, our direct-to-patient digital health care platform, to provide delivery of select Lilly medicines dispensed by third-party pharmacies to patients.

Tools to help patients access care from independent healthcare providers and programs to assist patients in adhering to treatment plans are also available on the platform where applicable.

We provide disease-state information directly to consumers via websites, social channels, and local activations.

We face intensifying competition worldwide, including from China and other markets that have significantly expanded and accelerated research and development capabilities.

Companies in these markets are increasingly licensing products to multinational pharmaceutical companies, entering into strategic partnerships, and competing directly in major markets.

Our ability to compete effectively depends on our capacity to innovate at the pace of global scientific advancement, to access innovation through strategic partnerships and licensing arrangements across geographies, and to efficiently bring differentiated products to market.

Loss of market exclusivity for competitive products may also shift market conditions for other branded products in the same therapeutic class.

Regulatory interpretation of important aspects of the laws regulating biosimilars continues to evolve.

In the U.S., for example, the U.S. Food and Drug Administration (FDA) has proposed changes in policy that could streamline the process of, and accelerate the timeline for, biosimilar development, including potentially minimizing the requirement for comparative clinical efficacy studies.

In response to these issues, we are developing and deploying alternative product access strategies, including through direct-to-patient channels (such as LillyDirect) and direct-to-employer channels.

These strategies may not adequately mitigate unfavorable private sector dynamics.

An agreement-in-principle, announced in December 2025 between the European Commission, Council, and Parliament, would set a base level of 8 years of data protection, with additional incentives conditional on certain requirements, while overall reducing the maximum protection available by one year.

For more information on risks to the adequacy and effectiveness of our intellectual property, see Item 1A, "Risk Factors—Risks 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."

| data protection | | | U.S. | | | 2030 | | | | | | | | |

| Japan | | | 2039 | | | | | | | | | | | |

| Japan | | | 2033 | | | | | | | | | | | |

| major European countries | | | 2036 | | | | | | | | | | | |

* Jardiance is part of our Boehringer Ingelheim collaboration.

See Item 8, "Financial Statements and Supplementary Data—Note 3: Collaborations and Other Arrangements".

- Orforglipron has been submitted for regulatory review in the U.S., the EU, and Japan for the treatment of obesity or overweight with at least one weight-related medical problem and in the EU for the treatment of type 2 diabetes.

Orforglipron was granted a Commissioner’s National Priority Voucher from the FDA, which could accelerate potential U.S. approval timing.

U.S. and other authorities are actively proposing, enacting, and pursuing numerous policy, regulatory, and enforcement changes that impact our business.

These changes create additional uncertainty for our business, while in some cases presenting new opportunities for our business.

In November 2025, we announced preliminary voluntary agreements with the U.S. government in which, among other arrangements, we agreed to implement measures to lower Medicaid and certain other drug prices for U.S. patients and to launch new medicines with a more balanced pricing approach across developed nations.

As part of these agreements, we expect Medicare beneficiaries will have access to discounted Lilly obesity medicines by July 1, 2026, and States will have the option to expand access to these discounted medicines through Medicaid.

We will also participate in a government direct-to-patient purchasing platform that will direct people in the U.S. to offerings to purchase certain medicines from us at significant discounts to current list prices.

The preliminary agreements also provide a three-year grace period during which time our products under a Section 232 investigation will not face tariffs, provided that we meet U.S. manufacturing investment commitments.

We are currently in the process of negotiating definitive agreements to implement these arrangements.

under the 340B Drug Pricing Program, potentially leading to a negative impact on both Medicaid and 340B prices.

In January 2026, HHS selected Trulicity and Verzenio as additional medicines subject to government-set prices to be effective in 2028.

Other aspects of the 340B program, including the manner in which manufacturers can offer 340B pricing, and proper definitions of "patient" and "child site" under the 340B statute, are subject to inquiries and ongoing litigation by Lilly and/or other parties, the resolution of which could impact the growth and scope of the 340B program.

The U.S. District Court for the District of Columbia agreed with HRSA in May 2025 that the government must preapprove Lilly’s cash replenishment model, which HRSA has not done.

Lilly appealed that decision to the U.S. Court of Appeals for the District of Columbia.

Furthermore, states continue to adopt laws that, among other things, expand the 340B program by purporting to compel manufacturers to sell their medicines at 340B prices to an unlimited number of contract pharmacies.

Other manufacturers and trade associations continue to litigate the constitutionality of these laws in various federal courts.

Some courts have concluded that such laws are unconstitutional and have preliminarily enjoined them while others have rejected those challenges.

In December 2025 the European Commission, Council, and Parliament reached an agreement-in-principle on EU Pharmaceutical Legislation.

The implementation timeline and eventual impact on patients and the overall market is currently uncertain.

The impact of the U.S. government’s efforts to use trade or other measures to increase spending by developed countries on innovative medicines to reduce U.S. prices remains unclear.

U.S.

We recently launched LillyDirect, a direct-to-consumer digital health care platform designed to, among other things, provide patients in the U.S. living with obesity, migraine and diabetes with tools to help them access care from independent healthcare providers, as well as the option for home delivery of select prescribed Lilly medicines through third-party pharmacies.

Programs to assist patients in adhering to treatment plans are also available for use.

business and reputation" and "Risk Factors—Risks Related to Litigation and Government Regulation—Regulatory compliance problems could be damaging to the company."

Outside the U.S.

Marketing Collaborations

For example, we and Boehringer Ingelheim have a global agreement to develop and commercialize a portfolio of diabetes products, including Jardiance, Glyxambi, Synjardy, and Trijardy XR.

For example, in the U.S., anti-obesity medicines are often excluded from commercial benefit plans.

Generic Pharmaceuticals, Biosimilars, and Compounding

For example, the extent to which a biosimilar, once approved, will be substituted for the innovator biologic in a way that is similar to traditional generic substitution for non-biologic products will depend on a number of regulatory and marketplace factors that are still developing.

Biosimilars may present both competitive challenges and opportunities.

While competitors have developed biosimilars that compete with our products, we have developed our own biosimilar and may develop others in the future.

Legislative bodies in the European Union (EU) are discussing proposed reductions in data protection periods but it remains uncertain if, or when, these proposals might be adopted.

| | | | | | | | | | | | | | | |

| Japan | | | 2024 | | | | | | | | | | | |

| data protection | | | Japan | | | 2032 | | | | | | | | |

| Japan | | | 2028 | | | | | | | | | | | |

- Imlunestrant has been submitted for regulatory review in the U.S., the EU, and Japan for the treatment of ER-positive HER2-negative metastatic breast cancer.

In addition, changing political leadership, including the new presidential administration and regulatory authorities in the U.S., may propose, enact, or pursue policy, regulatory, and enforcement changes that create additional uncertainty for our business.

respect to pharmaceutical companies, which has resulted in intensified scrutiny, litigation costs, corporate criminal sanctions, and substantial civil settlements in the pharmaceutical industry.

Also, on January 1, 2025 the Part D benefit redesign replaced the Part D Coverage Gap Discount Program (CGDP) with the new Manufacturer Discount Program (MDP).

The 70 percent CGDP discount was replaced by a 10 percent MDP discount for all Medicare Part D beneficiaries that have met their deductible and incurred out of pocket drug costs below a $2,000 threshold and a 20 percent MDP discount for beneficiaries that have incurred out of pocket drug costs above the $2,000 threshold under the new Part D benefit redesign.

Manufacturers that fail to comply with the IRA may be subject to various penalties, including civil monetary penalties, which could be significant.

Pharmacy benefit manager reform could be pursued or enacted in 2025.

The European Commission published its draft General Pharmaceutical Legislation in April 2023.

While certain elements in the European Commission draft could expedite regulatory timelines, we anticipate that the overall market and patient impact would be negative if the legislation is approved as drafted.

Implementation timing is unknown at this time.

China has introduced and implemented reforms to accelerate access to innovative products and reduce costs.

For example, in periods of 2024, demand for our incretin medicines exceeded production.

We believe our dedication to promoting inclusion within our company makes Lilly a stronger and more innovative company.

At all times, we seek to hire the most qualified candidate for each open position.

Strategy and Oversight

We are committed to fairness and nondiscrimination in our employment practices, and we deeply value diverse backgrounds, skills, and global perspectives.

Because dedication to human capital management is also a core component of our corporate governance, our board of directors regularly engages with management to monitor human capital management initiatives and progress as part of the overarching framework that guides how we attract, retain, engage, and develop a workforce that aligns with our values and mission.

Employee Health and Safety

We strive to foster a healthy, vibrant work environment, which includes keeping our employees safe.

We seek to create a companywide culture where best-in-class safety practices are consistently followed.

To do this, we assess and continuously attempt to improve our companywide safety performance to promote the well-being of employees and to help safeguard communities where we operate.

We believe a holistic approach and dedication to safety helps us be our best as we deliver on our company purpose to improve lives around the world.

Information pertaining to legal proceedings is described in Item 8, "Financial Statements and Supplementary [removed: Data - Note] [added: Data—Note] 16: Contingencies," and incorporated by reference herein.

for the fiscal year ended December 31, [removed: 2024][added: 2025]

Aggregate market value of the common equity held by non-affiliates computed by reference to the price at which the common equity was last sold as of the last business day of the Registrant's most recently completed second fiscal quarter: approximately [removed: $769,792,000,000.][added: $807,887,000,000.]

Number of shares of common stock outstanding as of February [removed: 14, 2025: 948,169,999][added: 9, 2026: 943,357,420]

Portions of the Registrant's Proxy Statement for the [removed: 2025] [added: 2026] Annual Meeting of Shareholders have been incorporated by reference into Part III of this Annual Report on Form 10-K.

For the Year Ended December 31, [removed: 2024][added: 2025]

| [Item [removed: 1.](#i34e43bfda1e54e63806263d62104c693_16)] [added: 1.](#ie29e2ff1768b405fafd5fdbb3e5057f6_16)] | | | | | | [removed: [Business](#i34e43bfda1e54e63806263d62104c693_16)] [added: [Business](#ie29e2ff1768b405fafd5fdbb3e5057f6_16)] | | | | | | [removed: [5](#i34e43bfda1e54e63806263d62104c693_16)] [added: [5](#ie29e2ff1768b405fafd5fdbb3e5057f6_16)] | | |

| [Item [removed: 1A.](#i34e43bfda1e54e63806263d62104c693_19)] [added: 1A.](#ie29e2ff1768b405fafd5fdbb3e5057f6_19)] | | | | | | [Risk [removed: Factors](#i34e43bfda1e54e63806263d62104c693_19)] [added: Factors](#ie29e2ff1768b405fafd5fdbb3e5057f6_19)] | | | | | | [removed: [24](#i34e43bfda1e54e63806263d62104c693_19)] [added: [25](#ie29e2ff1768b405fafd5fdbb3e5057f6_19)] | | |

| [Item [removed: 1B.](#i34e43bfda1e54e63806263d62104c693_22)] [added: 1B.](#ie29e2ff1768b405fafd5fdbb3e5057f6_22)] | | | | | | [Unresolved Staff [removed: Comments](#i34e43bfda1e54e63806263d62104c693_22)] [added: Comments](#ie29e2ff1768b405fafd5fdbb3e5057f6_22)] | | | | | | [removed: [37](#i34e43bfda1e54e63806263d62104c693_22)] [added: [38](#ie29e2ff1768b405fafd5fdbb3e5057f6_22)] | | |

| [Item [removed: 1C.](#i34e43bfda1e54e63806263d62104c693_25)] [added: 1C.](#ie29e2ff1768b405fafd5fdbb3e5057f6_25)] | | | | | | [removed: [Cybersecurity](#i34e43bfda1e54e63806263d62104c693_25)] [added: [Cybersecurity](#ie29e2ff1768b405fafd5fdbb3e5057f6_25)] | | | | | | [removed: [37](#i34e43bfda1e54e63806263d62104c693_25)] [added: [39](#ie29e2ff1768b405fafd5fdbb3e5057f6_25)] | | |

| [Item [removed: 2.](#i34e43bfda1e54e63806263d62104c693_28)] [added: 2.](#ie29e2ff1768b405fafd5fdbb3e5057f6_28)] | | | | | | [removed: [Properties](#i34e43bfda1e54e63806263d62104c693_28)] [added: [Properties](#ie29e2ff1768b405fafd5fdbb3e5057f6_28)] | | | | | | [removed: [38](#i34e43bfda1e54e63806263d62104c693_28)] [added: [40](#ie29e2ff1768b405fafd5fdbb3e5057f6_28)] | | |

| [Item [removed: 3.](#i34e43bfda1e54e63806263d62104c693_31)] [added: 3.](#ie29e2ff1768b405fafd5fdbb3e5057f6_31)] | | | | | | [Legal [removed: Proceedings](#i34e43bfda1e54e63806263d62104c693_31)] [added: Proceedings](#ie29e2ff1768b405fafd5fdbb3e5057f6_31)] | | | | | | [removed: [38](#i34e43bfda1e54e63806263d62104c693_31)] [added: [40](#ie29e2ff1768b405fafd5fdbb3e5057f6_31)] | | |

| [Item [removed: 4.](#i34e43bfda1e54e63806263d62104c693_34)] [added: 4.](#ie29e2ff1768b405fafd5fdbb3e5057f6_34)] | | | | | | [Mine Safety [removed: Disclosures](#i34e43bfda1e54e63806263d62104c693_34)] [added: Disclosures](#ie29e2ff1768b405fafd5fdbb3e5057f6_34)] | | | | | | [removed: [38](#i34e43bfda1e54e63806263d62104c693_34)] [added: [40](#ie29e2ff1768b405fafd5fdbb3e5057f6_34)] | | |

| [Item [removed: 5.](#i34e43bfda1e54e63806263d62104c693_40)] [added: 5.](#ie29e2ff1768b405fafd5fdbb3e5057f6_40)] | | | | | | [Market for the Registrant's Common Equity, Related Stockholder Matters, and Issuer Purchases of Equity [removed: Securities](#i34e43bfda1e54e63806263d62104c693_40)] [added: Securities](#ie29e2ff1768b405fafd5fdbb3e5057f6_40)] | | | | | | [removed: [39](#i34e43bfda1e54e63806263d62104c693_40)] [added: [41](#ie29e2ff1768b405fafd5fdbb3e5057f6_40)] | | |

| [Item [removed: 6.](#i34e43bfda1e54e63806263d62104c693_46)] [added: 6.](#ie29e2ff1768b405fafd5fdbb3e5057f6_46)] | | | | | | [removed: [\[Reserved\]](#i34e43bfda1e54e63806263d62104c693_46)] [added: [\[Reserved\]](#ie29e2ff1768b405fafd5fdbb3e5057f6_46)] | | | | | | [removed: [41](#i34e43bfda1e54e63806263d62104c693_46)] [added: [43](#ie29e2ff1768b405fafd5fdbb3e5057f6_46)] | | |

| [Item [removed: 7.](#i34e43bfda1e54e63806263d62104c693_49)] [added: 7.](#ie29e2ff1768b405fafd5fdbb3e5057f6_49)] | | | | | | [Management's Discussion and Analysis of Results of Operations and Financial [removed: Condition](#i34e43bfda1e54e63806263d62104c693_49)] [added: Condition](#ie29e2ff1768b405fafd5fdbb3e5057f6_49)] | | | | | | [removed: [41](#i34e43bfda1e54e63806263d62104c693_49)] [added: [43](#ie29e2ff1768b405fafd5fdbb3e5057f6_49)] | | |

| [Item [removed: 7A.](#i34e43bfda1e54e63806263d62104c693_73)] [added: 7A.](#ie29e2ff1768b405fafd5fdbb3e5057f6_73)] | | | | | | [Quantitative and Qualitative Disclosures About Market [removed: Risk](#i34e43bfda1e54e63806263d62104c693_73)] [added: Risk](#ie29e2ff1768b405fafd5fdbb3e5057f6_73)] | | | | | | [removed: [57](#i34e43bfda1e54e63806263d62104c693_73)] [added: [56](#ie29e2ff1768b405fafd5fdbb3e5057f6_73)] | | |

| [Item [removed: 8.](#i34e43bfda1e54e63806263d62104c693_76)] [added: 8.](#ie29e2ff1768b405fafd5fdbb3e5057f6_76)] | | | | | | [Financial Statements and Supplementary [removed: Data](#i34e43bfda1e54e63806263d62104c693_76)] [added: Data](#ie29e2ff1768b405fafd5fdbb3e5057f6_76)] | | | | | | [removed: [58](#i34e43bfda1e54e63806263d62104c693_76)] [added: [57](#ie29e2ff1768b405fafd5fdbb3e5057f6_76)] | | |

| [Item [removed: 9.](#i34e43bfda1e54e63806263d62104c693_160)] [added: 9.](#ie29e2ff1768b405fafd5fdbb3e5057f6_166)] | | | | | | [Changes in and Disagreements with Accountants on Accounting and Financial [removed: Disclosure](#i34e43bfda1e54e63806263d62104c693_160)] [added: Disclosure](#ie29e2ff1768b405fafd5fdbb3e5057f6_166)] | | | | | | [removed: [114](#i34e43bfda1e54e63806263d62104c693_160)] [added: [98](#ie29e2ff1768b405fafd5fdbb3e5057f6_166)] | | |

| [Item [removed: 9A.](#i34e43bfda1e54e63806263d62104c693_163)] [added: 9A.](#ie29e2ff1768b405fafd5fdbb3e5057f6_169)] | | | | | | [Controls and [removed: Procedures](#i34e43bfda1e54e63806263d62104c693_163)] [added: Procedures](#ie29e2ff1768b405fafd5fdbb3e5057f6_169)] | | | | | | [removed: [114](#i34e43bfda1e54e63806263d62104c693_163)] [added: [98](#ie29e2ff1768b405fafd5fdbb3e5057f6_169)] | | |

| [Item [removed: 9B.](#i34e43bfda1e54e63806263d62104c693_166)] [added: 9B.](#ie29e2ff1768b405fafd5fdbb3e5057f6_172)] | | | | | | [Other [removed: Information](#i34e43bfda1e54e63806263d62104c693_166)] [added: Information](#ie29e2ff1768b405fafd5fdbb3e5057f6_172)] | | | | | | [removed: [114](#i34e43bfda1e54e63806263d62104c693_166)] [added: [98](#ie29e2ff1768b405fafd5fdbb3e5057f6_172)] | | |

| [Item [removed: 9C.](#i34e43bfda1e54e63806263d62104c693_172)] [added: 9C.](#ie29e2ff1768b405fafd5fdbb3e5057f6_178)] | | | | | | [Disclosure Regarding Foreign Jurisdictions that Prevent [removed: Inspections](#i34e43bfda1e54e63806263d62104c693_172)] [added: Inspections](#ie29e2ff1768b405fafd5fdbb3e5057f6_178)] | | | | | | [removed: [114](#i34e43bfda1e54e63806263d62104c693_172)] [added: [98](#ie29e2ff1768b405fafd5fdbb3e5057f6_178)] | | |

| [Item [removed: 10.](#i34e43bfda1e54e63806263d62104c693_178)] [added: 10.](#ie29e2ff1768b405fafd5fdbb3e5057f6_184)] | | | | | | [Directors, Executive Officers, and Corporate [removed: Governance](#i34e43bfda1e54e63806263d62104c693_178)] [added: Governance](#ie29e2ff1768b405fafd5fdbb3e5057f6_184)] | | | | | | [removed: [115](#i34e43bfda1e54e63806263d62104c693_178)] [added: [99](#ie29e2ff1768b405fafd5fdbb3e5057f6_184)] | | |

| [Item [removed: 11.](#i34e43bfda1e54e63806263d62104c693_181)] [added: 11.](#ie29e2ff1768b405fafd5fdbb3e5057f6_187)] | | | | | | [Executive [removed: Compensation](#i34e43bfda1e54e63806263d62104c693_181)] [added: Compensation](#ie29e2ff1768b405fafd5fdbb3e5057f6_187)] | | | | | | [removed: [115](#i34e43bfda1e54e63806263d62104c693_181)] [added: [99](#ie29e2ff1768b405fafd5fdbb3e5057f6_187)] | | |

| [Item [removed: 12.](#i34e43bfda1e54e63806263d62104c693_184)] [added: 12.](#ie29e2ff1768b405fafd5fdbb3e5057f6_190)] | | | | | | [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder [removed: Matters](#i34e43bfda1e54e63806263d62104c693_184)] [added: Matters](#ie29e2ff1768b405fafd5fdbb3e5057f6_190)] | | | | | | [removed: [116](#i34e43bfda1e54e63806263d62104c693_184)] [added: [100](#ie29e2ff1768b405fafd5fdbb3e5057f6_190)] | | |

| [Item [removed: 13.](#i34e43bfda1e54e63806263d62104c693_187)] [added: 13.](#ie29e2ff1768b405fafd5fdbb3e5057f6_193)] | | | | | | [Certain Relationships and Related Transactions, and Director [removed: Independence](#i34e43bfda1e54e63806263d62104c693_187)] [added: Independence](#ie29e2ff1768b405fafd5fdbb3e5057f6_193)] | | | | | | [removed: [116](#i34e43bfda1e54e63806263d62104c693_187)] [added: [100](#ie29e2ff1768b405fafd5fdbb3e5057f6_193)] | | |

| [Item [removed: 14.](#i34e43bfda1e54e63806263d62104c693_190)] [added: 14.](#ie29e2ff1768b405fafd5fdbb3e5057f6_196)] | | | | | | [Principal Accountant Fees and [removed: Services](#i34e43bfda1e54e63806263d62104c693_190)] [added: Services](#ie29e2ff1768b405fafd5fdbb3e5057f6_196)] | | | | | | [removed: [116](#i34e43bfda1e54e63806263d62104c693_190)] [added: [100](#ie29e2ff1768b405fafd5fdbb3e5057f6_196)] | | |

| [Item [removed: 15.](#i34e43bfda1e54e63806263d62104c693_193)] [added: 15.](#ie29e2ff1768b405fafd5fdbb3e5057f6_199)] | | | | | | [Exhibits and Financial Statement [removed: Schedules](#i34e43bfda1e54e63806263d62104c693_193)] [added: Schedules](#ie29e2ff1768b405fafd5fdbb3e5057f6_199)] | | | | | | [removed: [117](#i34e43bfda1e54e63806263d62104c693_193)] [added: [101](#ie29e2ff1768b405fafd5fdbb3e5057f6_199)] | | |

| [Item [removed: 16.](#i34e43bfda1e54e63806263d62104c693_199)] [added: 16.](#ie29e2ff1768b405fafd5fdbb3e5057f6_205)] | | | | | | [Form 10-K [removed: Summary](#i34e43bfda1e54e63806263d62104c693_199)] [added: Summary](#ie29e2ff1768b405fafd5fdbb3e5057f6_205)] | | | | | | [removed: [118](#i34e43bfda1e54e63806263d62104c693_199)] [added: [102](#ie29e2ff1768b405fafd5fdbb3e5057f6_205)] | | |

- the significant costs and uncertainties in the pharmaceutical research and development process, including with respect to the timing and process of obtaining regulatory [removed: approvals;][added: approvals and the ability of the company's clinical trials to meet expectations;]

- continued pricing pressures and the impact of actions of governmental and private [removed: payers] [added: actors] affecting pricing of, reimbursement for, and patient access to pharmaceuticals, or reporting obligations related thereto;

- [removed: safety] [added: developments] or [removed: efficacy concerns associated with] [added: uncertainties related to] our or competitive [removed: products;][added: products, including as may relate to safety or efficacy concerns;]

- issues with product [removed: supply and] [added: supply,] regulatory [removed: approvals] [added: approvals, or other negative outcomes] stemming from manufacturing difficulties, disruptions, or shortages, including as a result of unpredictability and variability in demand, labor shortages, third-party performance, quality, cyber-attacks, or regulatory actions related to our and third-party facilities;

- the use of artificial intelligence or other emerging technologies in various facets of our [removed: operations] [added: operations, including partnerships related to the use of, or the sharing of, such technologies with third parties, which] may exacerbate competitive, regulatory, litigation, cybersecurity, and other risks;

- the impact of global macroeconomic conditions, including uneven economic growth or downturns or uncertainty, trade [removed: disruptions,] [added: and other global disputes and interruptions, including related to tariffs, trade protection measures, and similar restrictions,] international tension, conflicts, regional dependencies, or other costs, uncertainties, and risks related to engaging in business globally;

- [removed: devaluations] [added: fluctuations] in foreign currency exchange rates, changes in interest rates, and inflation or deflation;

- litigation, investigations, or other similar proceedings involving past, current, or future [removed: products] [added: products, activities,] or [removed: activities;][added: intellectual property;]

- regulatory [removed: changes] [added: changes, developments,] and [removed: developments;][added: uncertainty;]

| [Part I](#ie29e2ff1768b405fafd5fdbb3e5057f6_13) | | | | | | | | | | | | | | |

| [Part II](#ie29e2ff1768b405fafd5fdbb3e5057f6_37) | | | | | | | | | | | | | | |

| [Part III](#ie29e2ff1768b405fafd5fdbb3e5057f6_181) | | | | | | | | | | | | | | |

- negotiation and implementation of our voluntary agreement with the U.S. government related to drug pricing and access;

| 7 1/8% Notes due 2025 | | | LLY25 | | | New York Stock Exchange | | |

| [Part I](#i34e43bfda1e54e63806263d62104c693_13) | | | | | | | | | | | | | | |

| [Part II](#i34e43bfda1e54e63806263d62104c693_37) | | | | | | | | | | | | | | |

| [Part III](#i34e43bfda1e54e63806263d62104c693_175) | | | | | | | | | | | | | | |

As examples, we generally review current and prospective third-party service providers for unacceptable cybersecurity risks, negotiate contractual provisions that require the establishment of third-party cybersecurity controls, and deploy [removed: communications] security measures to protect third-party communications.

For companies we acquire, the integration process includes plans for alignment with relevant information security policies and [removed: procedures and timelines for implementation.][added: procedures.]

We describe [added: certain] risks faced by us from identified cybersecurity threats in Item 1A, "Risk Factors—Risks 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 [removed: each] result in material harm to our business and reputation", "Risk Factors—Risks Related to Our Operations—Manufacturing, quality, or supply chain difficulties, disruptions, or shortages could lead to product supply [removed: problems",] [added: problems or other negative outcomes",] "Risk Factors—Risks Related to Our Operations—Reliance on third-party relationships and outsourcing arrangements could adversely affect our business", and "Risk Factors—Risks Related to Our Operations—Our use of artificial intelligence (AI) or other emerging technologies could adversely impact [removed: our business and financial results."][added: us."]

The audit committee of our board of directors is responsible for oversight of [removed: the company's] [added: our] programs, policies, procedures, and risk management activities related to information [removed: security] [added: security, cybersecurity] and data protection.

The audit committee meets regularly with our [removed: CIDO] [added: CIDO, CISO,] and [removed: CISO] [added: Chief Privacy Officer] to discuss threats, risks, and ongoing efforts to enhance cyber resiliency, as well as changes to the broader cybersecurity landscape.

Our board of directors [removed: also] [added: monitors cybersecurity risks and] regularly participates in presentations on cybersecurity and information technology.

We own several production, distribution, and corporate administrative sites in the [removed: United States (U.S.),] [added: U.S.,] including Puerto Rico.

Major production sites include facilities in Indiana, North Carolina, Puerto Rico, and [removed: New Jersey.][added: Wisconsin.]

[removed: In the U.S., our] [added: Our] research and development facilities [added: are] primarily [added: located in the U.S. and] consist of owned facilities [removed: located] in Indiana and leased sites in California, Massachusetts, [removed: New York,] [added: Colorado,] and [removed: Colorado.][added: New York.]

Outside the U.S., we own a small research and development facility in Spain and lease a small site in Singapore.

Information relating to [removed: the principal market for] our [removed: common stock, dividends,] [added: dividends] and related stockholder matters is described in Item 7, "Management's Discussion and Analysis of Results of Operations and Financial Condition" and Item 12, "Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters." This information is incorporated herein by reference.

As of February [removed: 14, 2025,] [added: 9, 2026,] there were approximately [removed: 17,903] [added: 16,886] holders of record of our common stock based on information provided by EQ Shareowner Services, our transfer agent.

The following table summarizes the activity related to repurchases of our equity securities during the three months ended December 31, [removed: 2024:][added: 2025:]

During the three months ended December 31, [removed: 2024,] [added: 2025,] we repurchased [removed: the remaining $1.98] [added: $1.5] billion of shares under our [removed: $5.00] [added: $15.0] billion share repurchase program that our board authorized in [removed: May 2021.][added: December 2024.]

The following graph compares the return on Lilly stock with that of the Standard & Poor's (S&P) 500 Stock Index and our peer [removed: group] [added: groups] for the years [removed: 2020] [added: 2021] through [removed: 2024.][added: 2025.]

The graph assumes that, on the last business day of [removed: 2019,] [added: 2020,] a person invested $100 each in Lilly stock, the S&P 500 Stock Index, and [added: each of] the peer [removed: group's] [added: groups'] collective common stock.

[removed: ][added: ]

[removed: It is] [added: (2) Prior to 2025, the peer group we used as the industry index for this graph was] comprised of the following companies in the pharmaceutical and biotechnology industries: AbbVie Inc.; Amgen Inc.; AstraZeneca PLC; Biogen Inc.; Bristol-Myers Squibb Company; Gilead Sciences Inc.; GlaxoSmithKline plc; Johnson & Johnson; Merck & Co., Inc.; Novartis AG; Novo Nordisk A/S; Pfizer Inc.; Roche Holding AG; Sanofi S.A.; and Takeda Pharmaceutical Company Limited.

[removed: The] [added: (1) In 2025, we revised the] peer group used [added: as the industry index] for [removed: performance benchmarking aligns] [added: this graph to align] with the peer group used for executive compensation purposes for [removed: 2024.][added: 2025.]

| October 2025 | | | 472 | | | $ | 933.79 | | 472 | | | $ | 11,960 | |

| November 2025 | | | 877 | | | 1,033.47 | | | 877 | | | 11,053 | | |

| December 2025 | | | 130 | | | 1,032.42 | | | 130 | | | 10,919 | | |

| Total | | | 1,479 | | | 1,001.60 | | | 1,479 | | | | | |

Comparison of Five-Year Cumulative Total Shareholder Return

| | | | | | | | | | | | | | | | | | | | | | | | |

| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |

| | | | | | | 2020 | | | 2021 | | | 2022 | | | 2023 | | | 2024 | | | 2025 | | |

| Lilly | | | | | | $ | 100.00 | | $ | 166.08 | | $ | 222.94 | | $ | 358.72 | | $ | 478.17 | | $ | 670.56 | |

| Current Peer Group(1) | | | | | | 100.00 | | | 116.73 | | | 124.87 | | | 118.45 | | | 123.43 | | | 154.11 | | |

| Prior Peer Group(2) | | | | | | 100.00 | | | 120.85 | | | 134.50 | | | 132.73 | | | 134.53 | | | 157.61 | | |

| S&P 500 | | | | | | 100.00 | | | 128.71 | | | 105.40 | | | 133.10 | | | 166.40 | | | 196.16 | | |

The 2025 peer group is comprised of the following companies in the pharmaceutical and biotechnology industries: AbbVie Inc.; Amgen Inc.; AstraZeneca PLC; Bristol-Myers Squibb Company; Gilead Sciences Inc.; GlaxoSmithKline plc; Johnson & Johnson; Medtronic plc; Merck & Co., Inc.; Novartis AG; Pfizer Inc.; Roche Holding AG; Sanofi S.A.; and Stryker Corporation.

| October 2024 | | | 717 | | | $ | 877.48 | | 717 | | | $1,350.0 | | |

| November 2024 | | | 1,665 | | | 810.58 | | | 1,665 | | | — | | |

| December 2024 | | | — | | | — | | | — | | | 15,000.0 | | |

| Total | | | 2,382 | | | 830.70 | | | 2,382 | | | | | |

Our board authorized a $15.00 billion share repurchase program in December 2024.

No shares were repurchased under this new program as of December 31, 2024.

Value of $100 Invested on Last Business Day of 2019 Comparison of Five-Year Cumulative Total Shareholder Return Among Lilly, S&P 500 Stock Index, and Peer Group(1)

| | | | | | | | | | | | | | | | | | | | | |

| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |

| | | | | | | Lilly | | | | | | Peer Group | | | | | | S&P 500 | | |

| Dec-19 | | | | | | $ | 100.00 | | | | | $ | 100.00 | | | | | $ | 100.00 | |

| Dec-20 | | | | | | 131.06 | | | | | | 102.07 | | | | | | 118.40 | | |

| Dec-21 | | | | | | 217.66 | | | | | | 121.90 | | | | | | 152.39 | | |

| Dec-22 | | | | | | 292.18 | | | | | | 133.61 | | | | | | 124.79 | | |

| Dec-23 | | | | | | 470.13 | | | | | | 132.57 | | | | | | 157.59 | | |

| Dec-24 | | | | | | 626.69 | | | | | | 132.19 | | | | | | 197.02 | | |

(1) We constructed the peer group as the industry index for this graph.

(Dollars [added: and shares] in millions, except per-share [removed: data, and shares in thousands)][added: data)]

| | | | | | | | | | [removed: | | |] 2024 | | | | | | 2023 | | | [removed: | | | 2022 | | |]

| Marketing, selling, and administrative | | | | | | | | | | | | [removed: 8,593.8] [added: 11,094] | | | | | | [removed: 7,403.1] [added: 8,594] | | | | | | [removed: 6,440.4] [added: 7,404] | | |

| Acquired in-process research and development [removed: (Note 3)] | | | | | | | | | | | | [removed: 3,280.4] [added: 2,910] | | | | | | [removed: 3,799.8] [added: 3,280] | | | | | | [removed: 908.5] [added: 3,800] | | |

| Asset impairment, restructuring, and other special charges [removed: (Note 5)] | | | | | | | | | | | | [removed: 860.6] [added: 484] | | | | | | [removed: 67.7] [added: 861] | | | | | | [removed: 244.6] [added: 68] | | |

| [removed: Other—net,] [added: Recognized in other–net,] (income) [removed: expense (Note 18) | | | | | | | | |] [added: expense:] | | | [removed: 218.6] | | | | | | [removed: (96.7)] | | | | | | [removed: 320.9] | | |

| Basic | | | | | | | | | | | | $ | [removed: 11.76] [added: 23.00] | | | | | $ | [removed: 5.82] [added: 11.76] | | | | | $ | [removed: 6.93] [added: 5.82] | |

| Diluted | | | | | | | | | | | | $ | [removed: 11.71] [added: 22.95] | | | | | $ | [removed: 5.80] [added: 11.71] | | | | | $ | [removed: 6.90] [added: 5.80] | |

| [removed: Other] [added: Recognized in other] comprehensive income (loss): | | | | | | | | | | | | | | | | | | [removed: | | | | | | | | |]

| Other comprehensive income [removed: (loss) before income taxes] [added: (loss), net of taxes:] | | | | | | | | | | | | [removed: 299.8] | | | | | | [removed: (678.7)] | | | | | | [removed: 748.5] | | |

| Other comprehensive [removed: income (loss),] [added: income,] net of tax [removed: (Note 17)] | | | | | | | | | | | | [removed: 5.1] | | | | | | [removed: (482.4)] | | | | | | [removed: 498.5] | | | [added: | | | | | | 5 | | | | | | | | | | | | | | | | | | | | |]

(Dollars [removed: in millions,] [added: and] shares in [removed: thousands)][added: millions)]

| | | | | | | | | | | | | [added: 2025 | | | | | |] 2024 | | | | | | 2023 | | |

| Cash and cash equivalents [removed: (Note 7)] | | | | | | | | | | | | $ | [removed: 3,268.4] [added: 7,268] | | | | | $ | [removed: 2,818.6] [added: 3,268] | |

| Short-term investments [removed: (Note 7)] | | | [added: $] | [added: 105] | | | | | | | | [removed: 154.8] | | | | | | [removed: 109.1] | | | [added: | | | | | | | | | | | | | | |]

| Other receivables | | | [removed: | | | | | | | | | 2,269.7] [added: 39] | | | | | | [removed: 2,245.7] [added: 40] | | |

| Other current assets | | | | | | | | | | | | [removed: 111.4] [added: 147] | | | | | | [removed: 149.5] [added: 266] | | |

| Total current assets | | | | | | | | | | | | [removed: 32,739.7] [added: 55,629] | | | | | | [removed: 25,727.0] [added: 32,740] | | |

| Property and equipment, net [removed: (Note 9)] | | | | | | | | | | | | [removed: 17,102.4] [added: 24,675] | | | | | | [removed: 12,913.6] [added: 17,102] | | |

| Other noncurrent assets | | | | | | | | | | | | [removed: 5,719.7] [added: 6,992] | | | | | | [removed: 4,989.9] [added: 5,720] | | |

| Short-term borrowings and current maturities of long-term debt [removed: (Note 11)] | | | | | | | | | | | | $ | [removed: 5,117.1] [added: 1,635] | | | | | $ | [removed: 6,904.5] [added: 5,117] | |

| Sales rebates and discounts | | | | | | | | | | | | [removed: 11,539.3] [added: 17,382] | | | | | | [removed: 11,689.0] [added: 11,539] | | |

| Other current liabilities | | | [added: (73)] | | | | | | [added: (71)] | | | [removed: 5,051.4] | | | [added: (9)] | | | [removed: 3,281.3] | | | [added: (8) | | |]

| Total current liabilities | | | | | | | | | | | | [removed: 28,376.6] [added: 35,228] | | | | | | [removed: 27,293.2] [added: 28,376] | | |

| Long-term income taxes payable [removed: (Note 14)] | | | | | | | | | | | | [removed: 4,060.9] [added: 5,875] | | | | | | [removed: 3,849.2] [added: 4,061] | | |

| Other noncurrent liabilities | | | | | | | | | | | | [removed: 2,178.2] [added: 3,970] | | | | | | [removed: 2,240.6] [added: 3,479] | | |

| Total noncurrent liabilities | | | | | | | | | | | | [removed: 36,066.7] [added: 50,713] | | | | | | [removed: 25,849.4] [added: 36,067] | | |

| *Commitments and [removed: Contingencies (Note 16)*] [added: Contingencies*] | | | | | | | | | | | | | | | | | | | | |

[removed: | *Eli] [added: To the Shareholders and the Board of Directors of Eli] Lilly and Company [removed: Shareholders' Equity (Notes 12 and 13)* | | | | | | | | | | | | | | | | | | | | |]

| Additional paid-in capital | | | | | | | | | | | | [removed: 7,439.3] [added: 7,346] | | | | | | [removed: 7,250.4] [added: 7,439] | | |

| Employee benefit trust | | | | | | | | | | | | [removed: (3,013.2)] [added: (3,013)] | | | | | | [removed: (3,013.2)] [added: (3,013)] | | |

| Accumulated other comprehensive loss [removed: (Note 17)] | | | | | | | | | | | | [removed: (4,321.9)] [added: (2,880)] | | | | | | [removed: (4,327.0)] [added: (4,322)] | | |

| Total liabilities and equity | | | | | | | | | | | | $ | [removed: 78,714.9] [added: 112,476] | | | | | $ | [removed: 64,006.3] [added: 78,715] | |

| [removed: (Dollars in millions, except per-share data, and shares in thousands)] | | | Common Stock | | | | | | | | | | | | Additional Paid-in Capital | | | | | | Retained Earnings | | | | | | Employee Benefit Trust | | | | | | Accumulated Other Comprehensive Loss | | | | | | [removed: Common Stock in Treasury] | | | | | | | | | | | | [removed: Noncontrolling Interest] | | |

| Shares | | | | | | Amount | | | [removed: Shares] | | | | | | [removed: Amount] | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| Other comprehensive income, net of tax | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | [removed: 498.5] [added: 1,442] | | | | | | | | | | | | | | | | | | | | |

| Cash dividends declared per share: [removed: $4.07] [added: $4.69] | | | | | | | | | | | | | | | | | | | | | [removed: (3,667.5)] [added: (4,221)] | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| Issuance of stock under employee stock plans, net | | | [removed: 2,123] [added: 1.5] | | | | | | [removed: 1.3] [added: 1] | | | | | | [removed: (283.1)] [added: (300)] | | | | | | | | | | | | | | | | | | | | | | | | [removed: (13)] | | | | | | [removed: 2.2] | | | | | | | | |

| Stock-based compensation | | | | | | | | | | | | | | | [removed: 371.1] [added: 629] | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| Net income | | | | | | | | | | | | | | | | | | | | | [removed: 5,240.4] [added: 5,240] | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | [removed: 11.0] | | |

| Revenue | | | | | | | | | | | | $ | 65,179 | | | | | $ | 45,043 | | | | | $ | 34,124 | |

| Cost of sales | | | | | | | | | | | | 11,052 | | | | | | 8,418 | | | | | | 7,082 | | |

| Research and development | | | | | | | | | | | | 13,337 | | | | | | 10,991 | | | | | | 9,313 | | |

| | | | | | | | | | | | | 39,448 | | | | | | 32,363 | | | | | | 27,570 | | |

| Income before income taxes | | | | | | | | | | | | 25,731 | | | | | | 12,680 | | | | | | 6,554 | | |

| Income taxes | | | | | | | | | | | | 5,091 | | | | | | 2,090 | | | | | | 1,314 | | |

| Net income | | | | | | | | | | | | $ | 20,640 | | | | | $ | 10,590 | | | | | $ | 5,240 | |

| Basic | | | | | | | | | | | | 897.3 | | | | | | 900.6 | | | | | | 900.2 | | |

| Diluted | | | | | | | | | | | | 899.3 | | | | | | 904.1 | | | | | | 903.3 | | |

| Net income | | | | | | | | | | | | $ | 20,640 | | | | | $ | 10,590 | | | | | $ | 5,240 | |

| Foreign currency translation | | | | | | | | | | | | 1,241 | | | | | | (571) | | | | | | 55 | | |

| Retirement benefit plans | | | | | | | | | | | | 192 | | | | | | 519 | | | | | | (635) | | |

| Total other comprehensive income (loss) | | | | | | | | | | | | 1,442 | | | | | | 5 | | | | | | (482) | | |

| Comprehensive income | | | | | | | | | | | | $ | 22,082 | | | | | $ | 10,595 | | | | | $ | 4,758 | |

| | | | | | | | | | | | | 2025 | | | | | | 2024 | | |

| Accounts receivable | | | | | | | | | | | | 17,760 | | | | | | 11,006 | | |

| Inventories | | | | | | | | | | | | 13,744 | | | | | | 7,589 | | |

| Prepaid expenses | | | | | | | | | | | | 14,315 | | | | | | 8,341 | | |

| Investments | | | | | | | | | | | | 2,802 | | | | | | 3,216 | | |

| Goodwill | | | | | | | | | | | | 5,898 | | | | | | 5,770 | | |

| Other intangibles, net | | | | | | | | | | | | 6,521 | | | | | | 6,166 | | |

| Deferred tax assets | | | | | | | | | | | | 9,959 | | | | | | 8,001 | | |

| Total assets | | | | | | | | | | | | $ | 112,476 | | | | | $ | 78,715 | |

| Accounts payable | | | | | | | | | | | | 5,379 | | | | | | 3,229 | | |

| Employee compensation | | | | | | | | | | | | 2,375 | | | | | | 2,094 | | |

| *Equity* | | | | | | | | | | | | | | | | | | | | |

| Common stock—no par value Authorized shares: 3,200.0 Issued shares: 944.8 (2025) and 947.9 (2024) | | | | | | | | | | | | 590 | | | | | | 592 | | |

| Retained earnings | | | | | | | | | | | | 24,470 | | | | | | 13,545 | | |

| Other equity | | | | | | | | | | | | 22 | | | | | | 31 | | |

| Total equity | | | | | | | | | | | | 26,535 | | | | | | 14,272 | | |

(Dollars and shares in millions, except per-share data)

| Balance at January 1, 2023 | | | 950.6 | | | | | | $ | 594 | | | | | $ | 6,921 | | | | | $ | 10,043 | | | | | $ | (3,013) | | | | | $ | (3,845) | | | | | | | | | | | | | | | | | | | |

| Other | | | | | | | | | | | | | | | | | | | | | (1) | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| Balance at December 31, 2023 | | | 949.8 | | | | | | 594 | | | | | | 7,250 | | | | | | 10,312 | | | | | | (3,013) | | | | | | (4,327) | | | | | | | | | | | | | | | | | | | | |

| Net income | | | | | | | | | | | | | | | | | | | | | 10,590 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| Purchases of common stock | | | (3.0) | | | | | | (2) | | | | | | | | | | | | (2,498) | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| Other | | | | | | | | | | | | | | | | | | | | | (2) | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| Balance at December 31, 2024 | | | 947.9 | | | | | | 592 | | | | | | 7,439 | | | | | | 13,545 | | | | | | (3,013) | | | | | | (4,322) | | | | | | | | | | | | | | | | | | | | |

| Net income | | | | | | | | | | | | | | | | | | | | | 20,640 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| Purchases of common stock | | | (4.8) | | | | | | (3) | | | | | | | | | | | | (4,105) | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| Revenue (Note 2) | | | | | | | | | | | | $ | 45,042.7 | | | | | $ | 34,124.1 | | | | | $ | 28,541.4 | |

| Cost of sales | | | | | | | | | | | | 8,418.3 | | | | | | 7,082.2 | | | | | | 6,629.8 | | |

| Research and development | | | | | | | | | | | | 10,990.6 | | | | | | 9,313.4 | | | | | | 7,190.8 | | |

| | | | | | | | | | | | | 32,362.3 | | | | | | 27,569.5 | | | | | | 21,735.0 | | |

| Income before income taxes | | | | | | | | | | | | 12,680.4 | | | | | | 6,554.6 | | | | | | 6,806.4 | | |

| Income taxes (Note 14) | | | | | | | | | | | | 2,090.4 | | | | | | 1,314.2 | | | | | | 561.6 | | |

| Net income | | | | | | | | | | | | $ | 10,590.0 | | | | | $ | 5,240.4 | | | | | $ | 6,244.8 | |

| Basic | | | | | | | | | | | | 900,605 | | | | | | 900,181 | | | | | | 901,736 | | |

| Diluted | | | | | | | | | | | | 904,059 | | | | | | 903,284 | | | | | | 904,619 | | |

| Change in foreign currency translation gains (losses) | | | | | | | | | | | | (424.2) | | | | | | (25.8) | | | | | | (248.1) | | |

| Change in net unrealized gains (losses) on available-for-sale securities | | | | | | | | | | | | (7.1) | | | | | | 14.1 | | | | | | (53.2) | | |

| Change in retirement benefit plans (Note 15) | | | | | | | | | | | | 651.8 | | | | | | (776.5) | | | | | | 616.9 | | |

| Change in net unrealized gains (losses) on cash flow hedges | | | | | | | | | | | | 79.3 | | | | | | 109.5 | | | | | | 432.9 | | |

| Benefit (expense) for income taxes related to other comprehensive income (loss) | | | | | | | | | | | | (294.7) | | | | | | 196.3 | | | | | | (250.0) | | |

| Comprehensive income | | | | | | | | | | | | $ | 10,595.1 | | | | | $ | 4,758.0 | | | | | $ | 6,743.3 | |

| | | | | | | | | | | | | | | | | | | | | |

| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |

| Accounts receivable, net of allowances of $14.9 (2024) and $14.8 (2023) | | | | | | | | | | | | 11,005.7 | | | | | | 9,090.5 | | |

| Inventories (Note 6) | | | | | | | | | | | | 7,589.2 | | | | | | 5,772.8 | | |

| Prepaid expenses | | | | | | | | | | | | 8,340.5 | | | | | | 5,540.8 | | |

| Investments (Note 7) | | | | | | | | | | | | 3,215.9 | | | | | | 3,052.2 | | |

| Goodwill (Note 8) | | | | | | | | | | | | 5,770.3 | | | | | | 4,939.7 | | |

| Other intangibles, net (Note 8) | | | | | | | | | | | | 6,166.3 | | | | | | 6,906.6 | | |

| Deferred tax assets (Note 14) | | | | | | | | | | | | 8,000.6 | | | | | | 5,477.3 | | |

| Total assets | | | | | | | | | | | | $ | 78,714.9 | | | | | $ | 64,006.3 | |

| Accounts payable | | | | | | | | | | | | 3,228.6 | | | | | | 2,598.8 | | |

| Employee compensation | | | | | | | | | | | | 2,093.9 | | | | | | 1,650.4 | | |

| Dividends payable | | | | | | | | | | | | 1,346.3 | | | | | | 1,169.2 | | |

| Long-term debt (Note 11) | | | | | | | | | | | | 28,527.1 | | | | | | 18,320.8 | | |

| Accrued retirement benefits (Note 15) | | | | | | | | | | | | 1,300.5 | | | | | | 1,438.8 | | |

| Common stock—no par value Authorized shares: 3,200,000 Issued shares: 947,903 (2024) and 949,781 (2023) | | | | | | | | | | | | 592.4 | | | | | | 593.6 | | |

| Retained earnings | | | | | | | | | | | | 13,545.0 | | | | | | 10,312.3 | | |

| Cost of common stock in treasury | | | | | | | | | | | | (49.5) | | | | | | (44.2) | | |

| Total Eli Lilly and Company shareholders' equity | | | | | | | | | | | | 14,192.1 | | | | | | 10,771.9 | | |

| Noncontrolling interests | | | | | | | | | | | | 79.5 | | | | | | 91.8 | | |

| Total equity | | | | | | | | | | | | 14,271.6 | | | | | | 10,863.7 | | |

| | | | Equity of Eli Lilly and Company Shareholders | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| Balance at January 1, 2022 | | | 954,116 | | | | | | $ | 596.3 | | | | | $ | 6,833.4 | | | | | $ | 8,958.5 | | | | | $ | (3,013.2) | | | | | $ | (4,343.1) | | | | | 463 | | | | | | $ | (52.7) | | | | | $ | 175.6 | |

| Net income (loss) | | | | | | | | | | | | | | | | | | | | | 6,244.8 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | (20.9) | | |

| Retirement of treasury shares | | | (5,607) | | | | | | (3.5) | | | | | | | | | | | | (1,496.5) | | | | | | | | | | | | | | | | | | (5,607) | | | | | | 1,500.0 | | | | | | | | |

Our management, with the participation of David Ricks, president and chief executive officer, and Lucas Montarce, executive vice president and chief financial officer, evaluated our disclosure controls and procedures (as such term is defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934) as of December 31, [removed: 2024,] [added: 2025,] and concluded that they were effective.

Mr. Ricks and Mr. Montarce provided a report on behalf of management on our internal control over financial reporting, in which management concluded that the company's internal control over financial reporting is effective at December 31, [removed: 2024] [added: 2025] based on the framework in "Internal Control—Integrated Framework" (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission.

In addition, Ernst & Young LLP, the company's independent registered public accounting firm, issued an attestation report on the company's internal control over financial reporting as of December 31, [removed: 2024.][added: 2025.]

During the fourth quarter of [removed: 2024,] [added: 2025,] there were no changes in our internal control over financial reporting that materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

During the three months ended December 31, 2025, none of our directors or officers adopted or terminated a "Rule 10b5-1 trading arrangement" or "non-Rule 10b5-1 trading arrangement," as each term is defined in Item 408 of Regulation S-K.

On November 20, 2024, Donald Zakrowski, senior vice president, finance, and chief accounting officer, adopted a sales plan (Plan).

The Plan was entered into during an open trading window and is intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) of the Exchange Act of 1934 and our policies regarding trading in our securities.

The Plan calls for the sale of up to 4,000 shares of company common stock between March 13, 2025 and November 19, 2025 subject to the terms and conditions of the Plan.

Information relating to our board of directors is found in our Definitive Proxy Statement, to be dated on or about March [removed: 21, 2025] [added: 20, 2026] (Proxy Statement), under "Governance - How We Build an Effective Board" and is incorporated in this Annual Report on Form 10-K by reference.

Information relating to our insider trading [removed: procedure] [added: policy] and processes is found in our Proxy Statement under "Ownership of Company Stock - Common Stock Ownership by Directors and Executive Officers" and is incorporated in this Annual Report on Form 10-K by reference.

The following table presents information as of December 31, [removed: 2024] [added: 2025] regarding the company's compensation plans under which shares of the company's common stock have been authorized for issuance.

| Equity compensation plans approved by security holders | | | — | | | $ | — | | [removed: 48,827,102] [added: 42,396,427] | | |

(1) [removed: 2,396,006] [added: 3,484,792] shares are underlying outstanding equity awards.

| Total | | | — | | | — | | | 42,396,427 | | |

| Total | | | — | | | — | | | 48,827,102 | | |

- Consolidated Statements of Operations—Years Ended December 31, [added: 2025,] 2024, [removed: 2023,] and [removed: 2022][added: 2023]

- Consolidated Statements of Comprehensive Income—Years Ended December 31, [added: 2025,] 2024, [removed: 2023,] and [removed: 2022][added: 2023]

- Consolidated Balance Sheets—December 31, [removed: 2024] [added: 2025] and [removed: 2023][added: 2024]

- Consolidated Statements of Shareholders' Equity—Years Ended December 31, [added: 2025,] 2024, [removed: 2023,] and [removed: 2022][added: 2023]

- Consolidated Statements of Cash Flows—Years Ended December 31, [added: 2025,] 2024, [removed: 2023,] and [removed: 2022][added: 2023]

| 4.3 | | | | | | [Description of the Company's Common [removed: Stock](https://www.sec.gov/Archives/edgar/data/59478/000005947824000065/lly-20231231x10kexhibit43.htm)[,] [added: Stock,] incorporated by reference to Exhibit 4.3 to the Company’s Annual Report on Form 10-K for the year ended December 31, 2023](https://www.sec.gov/Archives/edgar/data/59478/000005947824000065/lly-20231231x10kexhibit43.htm) | | |

| 4.6 | | | | | | [Description of the Company's [removed: 7 1/8%] [added: 0.625%] Notes due [removed: 2025,] [added: 2031 and 1.700% Notes due 2049,] incorporated by reference to Exhibit [removed: 4.6 to] [added: 4.](https://www.sec.gov/Archives/edgar/data/59478/000005947820000057/lly-20191231x10kexhibit47.htm)[7](https://www.sec.gov/Archives/edgar/data/59478/000005947820000057/lly-20191231x10kexhibit47.htm) [to] the Company's Annual Report on Form 10-K for the year ended December 31, [removed: 2019](https://www.sec.gov/Archives/edgar/data/59478/000005947820000057/lly-20191231x10kexhibit46.htm)] [added: 2019](https://www.sec.gov/Archives/edgar/data/59478/000005947820000057/lly-20191231x10kexhibit47.htm)] | | |

| 4.7 | | | | | | [Description of the Company's [removed: 0.625%] [added: 0.500%] Notes due [removed: 2031] [added: 2033, 1.125% Notes due 2051,] and [removed: 1.700%] [added: 1.375%] Notes due [removed: 2049,] [added: 2061,] incorporated by reference to Exhibit [removed: 4.7 to] [added: 4.](https://www.sec.gov/Archives/edgar/data/59478/000005947822000068/lly-20211231x10kexhibit48.htm)[8](https://www.sec.gov/Archives/edgar/data/59478/000005947822000068/lly-20211231x10kexhibit48.htm) [to] the Company's Annual Report on Form 10-K for the year ended December 31, [removed: 2019](https://www.sec.gov/Archives/edgar/data/59478/000005947820000057/lly-20191231x10kexhibit47.htm)] [added: 2021](https://www.sec.gov/Archives/edgar/data/59478/000005947822000068/lly-20211231x10kexhibit48.htm)] | | |

| 4.8 | | | | | | [Description of the Company's [removed: 0.500% Notes due 2033, 1.125% Notes due 2051, and 1.375%] [added: 1.625%] Notes due [removed: 2061,] [added: 2043,] incorporated by reference to Exhibit [removed: 4.8 to] [added: 4.](https://www.sec.gov/Archives/edgar/data/59478/000005947822000068/lly-20211231x10kexhibit49.htm)[9](https://www.sec.gov/Archives/edgar/data/59478/000005947822000068/lly-20211231x10kexhibit49.htm) [to] the Company's Annual Report on Form 10-K for the year ended December 31, [removed: 2021](https://www.sec.gov/Archives/edgar/data/59478/000005947822000068/lly-20211231x10kexhibit48.htm)] [added: 2021](https://www.sec.gov/Archives/edgar/data/59478/000005947822000068/lly-20211231x10kexhibit49.htm)] | | |

| [removed: 4.9] [added: 97] | | | | | | [removed: [Description of the Company's 1.625% Notes due 2043,] [added: [Executive Compensation Recovery Policy,] incorporated by reference to Exhibit [removed: 4.9] [added: 97] to the [removed: Company's] [added: Company’s] Annual Report on Form 10-K for the year ended December 31, [removed: 2021](https://www.sec.gov/Archives/edgar/data/59478/000005947822000068/lly-20211231x10kexhibit49.htm)] [added: 2023](https://www.sec.gov/Archives/edgar/data/59478/000005947824000065/lly-20231231x10kexhibit97.htm)] | | |

| 10.1 | | | | | | [Amended and Restated 2002 Lilly Stock [removed: Plan(1),] [added: Plan](https://www.sec.gov/Archives/edgar/data/59478/000005947824000187/lly-06302024x10qxexhibit101.htm)[(1)](https://www.sec.gov/Archives/edgar/data/59478/000005947824000187/lly-06302024x10qxexhibit101.htm)[,] incorporated by reference to Exhibit 10.1 to the Company's Quarterly Report on Form 10-Q for the quarter ended June 30, 2024](https://www.sec.gov/Archives/edgar/data/59478/000005947824000187/lly-06302024x10qxexhibit101.htm) | | |

| 10.3 | | | | | | [Form [removed: of Shareholder Value Award] [added: of](https://www.sec.gov/Archives/edgar/data/59478/000005947826000013/lly-12312025x10kexhibit103.htm) [Revenue Growth](https://www.sec.gov/Archives/edgar/data/59478/000005947826000013/lly-12312025x10kexhibit103.htm) [Award] under the 2002 Lilly Stock [removed: Plan](https://www.sec.gov/Archives/edgar/data/59478/000005947825000067/lly-20241231x10kexhibit103.htm)[(1)](https://www.sec.gov/Archives/edgar/data/59478/000005947825000067/lly-20241231x10kexhibit103.htm)[*](https://www.sec.gov/Archives/edgar/data/59478/000005947825000067/lly-20241231x10kexhibit103.htm)] [added: Plan](https://www.sec.gov/Archives/edgar/data/59478/000005947826000013/lly-12312025x10kexhibit103.htm)[(1)](https://www.sec.gov/Archives/edgar/data/59478/000005947826000013/lly-12312025x10kexhibit103.htm)[*](https://www.sec.gov/Archives/edgar/data/59478/000005947826000013/lly-12312025x10kexhibit103.htm)] | | |

| 10.4 | | | | | | [Form of Relative Value Award under the 2002 Lilly Stock [removed: Plan](https://www.sec.gov/Archives/edgar/data/59478/000005947825000067/lly-20241231x10kexhibit104.htm)[(1)](https://www.sec.gov/Archives/edgar/data/59478/000005947825000067/lly-20241231x10kexhibit104.htm)[*](https://www.sec.gov/Archives/edgar/data/59478/000005947825000067/lly-20241231x10kexhibit104.htm)] [added: Plan](https://www.sec.gov/Archives/edgar/data/59478/000005947826000013/lly-12312025x10kexhibit104.htm)[(1)](https://www.sec.gov/Archives/edgar/data/59478/000005947826000013/lly-12312025x10kexhibit104.htm)[*](https://www.sec.gov/Archives/edgar/data/59478/000005947826000013/lly-12312025x10kexhibit104.htm)] | | |

| 10.5 | | | | | | [Form of Restricted Stock Unit Award under the 2002 Lilly Stock [removed: Plan](https://www.sec.gov/Archives/edgar/data/59478/000005947825000067/lly-20241231x10kexhibit105.htm)[(1)](https://www.sec.gov/Archives/edgar/data/59478/000005947825000067/lly-20241231x10kexhibit105.htm)[*](https://www.sec.gov/Archives/edgar/data/59478/000005947825000067/lly-20241231x10kexhibit105.htm)] [added: Plan](https://www.sec.gov/Archives/edgar/data/59478/000005947826000013/lly-12312025x10kexhibit105.htm)[(1)](https://www.sec.gov/Archives/edgar/data/59478/000005947826000013/lly-12312025x10kexhibit105.htm)[*](https://www.sec.gov/Archives/edgar/data/59478/000005947826000013/lly-12312025x10kexhibit105.htm)] | | |

| 10.7 | | | | | | [The Lilly Deferred Compensation Plan, as [removed: amended](https://www.sec.gov/Archives/edgar/data/59478/000005947825000067/lly-20241231x10kexhibit107.htm)[(1)](https://www.sec.gov/Archives/edgar/data/59478/000005947825000067/lly-20241231x10kexhibit107.htm)[*](https://www.sec.gov/Archives/edgar/data/59478/000005947825000067/lly-20241231x10kexhibit107.htm)] [added: amended](https://www.sec.gov/Archives/edgar/data/59478/000005947825000067/lly-20241231x10kexhibit107.htm)[(1)](https://www.sec.gov/Archives/edgar/data/59478/000005947825000067/lly-20241231x10kexhibit107.htm)[, incorporated by reference to Exhibit 10.7 to the Company's Annual Report on Form 10-K for the year ended December 31, 2024](https://www.sec.gov/Archives/edgar/data/59478/000005947825000067/lly-20241231x10kexhibit107.htm)] | | |

| 10.8 | | | | | | [The Lilly Directors' Deferral Plan, as [removed: amended](https://www.sec.gov/Archives/edgar/data/59478/000005947825000067/lly-20241231x10kexhibit108.htm)[(1](https://www.sec.gov/Archives/edgar/data/59478/000005947825000067/lly-20241231x10kexhibit108.htm)[)](https://www.sec.gov/Archives/edgar/data/59478/000005947825000067/lly-20241231x10kexhibit108.htm)[*](https://www.sec.gov/Archives/edgar/data/59478/000005947825000067/lly-20241231x10kexhibit108.htm)] [added: amended](https://www.sec.gov/Archives/edgar/data/59478/000005947825000067/lly-20241231x10kexhibit108.htm)[(1)](https://www.sec.gov/Archives/edgar/data/59478/000005947825000067/lly-20241231x10kexhibit108.htm)[, incorporated by reference to Exhibit 10.8 to the Company's Annual Report on Form 10-K for the year ended December 31, 2024](https://www.sec.gov/Archives/edgar/data/59478/000005947825000067/lly-20241231x10kexhibit108.htm)] | | |

| 10.10 | | | | | | [2007 Change in Control Severance Pay Plan for Select Employees, as [removed: amended](https://www.sec.gov/Archives/edgar/data/59478/000005947824000065/lly-20231231x10kexhibit1010.htm)[(1)](https://www.sec.gov/Archives/edgar/data/59478/000005947824000065/lly-20231231x10kexhibit1010.htm)[,](https://www.sec.gov/Archives/edgar/data/59478/000005947824000065/lly-20231231x10kexhibit1010.htm) [incorporated] [added: amended](https://www.sec.gov/Archives/edgar/data/59478/000005947824000065/lly-20231231x10kexhibit1010.htm)[(1)](https://www.sec.gov/Archives/edgar/data/59478/000005947824000065/lly-20231231x10kexhibit1010.htm)[, incorporated] by [removed: reference](https://www.sec.gov/Archives/edgar/data/59478/000005947824000065/lly-20231231x10kexhibit1010.htm) [to] [added: reference to] Exhibit 10.10 to the Company’s Annual Report on Form 10-K for the year ended December 31, 2023](https://www.sec.gov/Archives/edgar/data/59478/000005947824000065/lly-20231231x10kexhibit1010.htm) | | |

| 19 | | | | | | [removed: [Trading] [added: [Eli] Lilly [removed: Securities Global Procedure*](https://www.sec.gov/Archives/edgar/data/59478/000005947825000067/lly-20241231x10kexhibit19.htm)] [added: Insider Trading Policy*](https://www.sec.gov/Archives/edgar/data/59478/000005947826000013/lly-12312025x10kexhibit19.htm)] | | |

| 21 | | | | | | [List of [removed: Subsidiaries*](https://www.sec.gov/Archives/edgar/data/59478/000005947825000067/lly-20241231x10kexhibit21.htm)] [added: Subsidiaries*](https://www.sec.gov/Archives/edgar/data/59478/000005947826000013/lly-12312025x10kexhibit21.htm)] | | |

| 23 | | | | | | [Consent of Independent Registered Public Accounting [removed: Firm*](https://www.sec.gov/Archives/edgar/data/59478/000005947825000067/lly-20241231x10kexhibit23.htm)] [added: Firm*](https://www.sec.gov/Archives/edgar/data/59478/000005947826000013/lly-12312025x10kexhibit23.htm)] | | |

| 31.1 | | | | | | [Rule 13a-14(a) Certification of David Ricks, Chair, President, and Chief Executive [removed: Officer*](https://www.sec.gov/Archives/edgar/data/59478/000005947825000067/lly-20241231x10kexhibit311.htm)] [added: Officer*](https://www.sec.gov/Archives/edgar/data/59478/000005947826000013/lly-12312025x10kexhibit311.htm)] | | |

| 31.2 | | | | | | [Rule 13a-14(a) Certification [removed: of](https://www.sec.gov/Archives/edgar/data/59478/000005947825000067/lly-20241231x10kexhibit312.htm) [Lucas Montarce](https://www.sec.gov/Archives/edgar/data/59478/000005947825000067/lly-20241231x10kexhibit312.htm)[,] [added: of Lucas Montarce,] Executive Vice President and Chief Financial [removed: Officer*](https://www.sec.gov/Archives/edgar/data/59478/000005947825000067/lly-20241231x10kexhibit312.htm)] [added: Officer*](https://www.sec.gov/Archives/edgar/data/59478/000005947826000013/lly-12312025x10kexhibit312.htm)] | | |

| 32 | | | | | | [Section 1350 [removed: Certification*](https://www.sec.gov/Archives/edgar/data/59478/000005947825000067/lly-20241231x10kexhibit32.htm)] [added: Certification*](https://www.sec.gov/Archives/edgar/data/59478/000005947826000013/lly-12312025x10kexhibit32.htm)] | | |

| 24 | | | | | | [Power of Attorney](https://www.sec.gov/Archives/edgar/data/59478/000005947826000013/lly-12312025x10kexhibit24.htm)* | | |

| 97 | | | | | | [Executive Compensation Recovery Policy](https://www.sec.gov/Archives/edgar/data/59478/000005947824000065/lly-20231231x10kexhibit97.htm)[, incorporated by reference to Exhibit 97 to the Company’s Annual Report on Form 10-K for the year ended December 31, 2023](https://www.sec.gov/Archives/edgar/data/59478/000005947824000065/lly-20231231x10kexhibit97.htm) | | |

Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below on February [removed: 19, 2025] [added: 12, 2026] by the following persons on behalf of the Registrant and in the capacities indicated.

| [removed: /s/ Mary Lynne Hedley,] [added: MARY LYNNE HEDLEY,] Ph.D. | | | | | | [removed: Director] | | |

February 12, 2026

| * | | | | | | Director | | |

| * | | | | | | Director | | |

| * | | | | | | Director | | |

| CAROLYN BERTOZZI, Ph.D. | | | | | | | | |

| * | | | | | | Director | | |

| * | | | | | | Director | | |

| * | | | | | | Director | | |

| * | | | | | | Director | | |

| * | | | | | | Director | | |

| * | | | | | | Director | | |

| * | | | | | | Director | | |

| * | | | | | | Director | | |

| | | | | | | | | |

| | | | | | |

| --- | --- | --- | --- | --- | --- |

| *By | | | /s/ Lucas Montarce | | |

| | | | LUCAS MONTARCE As Attorney-in-Fact | | |

February 19, 2025

| /s/ Ralph Alvarez | | | | | | Director | | |

| /s/ Katherine Baicker, Ph.D. | | | | | | Director | | |

| /s/ Erik Fyrwald | | | | | | Director | | |

| MARY LYNNE HEDLEY, Ph. D. | | | | | | | | |

| /s/ Jamere Jackson | | | | | | Director | | |

| /s/ Kimberly Johnson | | | | | | Director | | |

| /s/ William Kaelin, Jr., M.D. | | | | | | Director | | |

| /s/ Juan Luciano | | | | | | Director | | |

| /s/ Jon Moeller | | | | | | Director | | |

| /s/ Gabrielle Sulzberger | | | | | | Director | | |