Eli Lilly (LLY) 10-K risk factor changes: FY2024 vs FY2023

Failure can occur at any point in the process, including in later stages after substantial [removed: investment.][added: investment and following meaningful cost for manufacturing capabilities and inventory to prepare for launch.]

As a result, [removed: most] [added: a significant portion of] funds invested in research and development programs will not generate [added: direct] financial returns.

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 organizations that are commensurate with clinical data, 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 [removed: reaching] [added: connecting with] healthcare professionals, including digitally [removed: given the increase in] [added: 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 [added: or future] products and indications, which in some cases leads to difficulty meeting product demand or, on the other hand, [added: lower volume growth,] excess inventory and related financial charges.

We cannot state with certainty when or whether our products and indications now under development will be approved or launched; whether, if initially granted, such approval will be maintained; whether we will be able to develop, license, or otherwise acquire additional product candidates, [removed: indications] [added: indications,] or products; or whether our products and indications, once launched, will be commercially successful.

Through internal innovation and business development we must maintain a [removed: continuous] flow of successful [removed: new] 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, or are displaced by competing products or therapies.

Our dependence on, or focus in, one or more key products or product classes [removed: may exacerbate] [added: exacerbates] this risk.

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

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

[removed: Increased] [added: 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 of our business development activities.

[removed: Accordingly, business] [added: 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 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.

See Item 1, "Business—Research and Development—Phases of New Drug [removed: Development" and] [added: Development,"] Item 7, "Management's Discussion and Analysis—Executive [removed: Overview—Late-Stage Pipeline,"] [added: Overview—Clinical Development Pipeline" and Item 8, "Financial Statements and Supplementary Data—Note 6: Inventories,"] for more details about our current product pipeline.

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

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

Our product revenues and prospects are adversely affected by [added: patient access issues,] the introduction by competitors of branded products that are first to market, have better marketplace access, have greater brand recognition or are perceived as superior by the marketplace, 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.

Our revenues are also adversely affected by treatment innovations, including new or superior modalities, that eliminate or minimize the need for treatment with our [removed: drugs.][added: existing products, and our existing products could be subject to decreased sales volumes, realized price reductions, or both.]

To continue to commercialize our products, and advance the research, development, and commercialization of additional modalities, indications, and product candidates, we have expanded, and will likely need to further expand, our workforce, [removed: including in the areas of manufacturing, clinical trials management, regulatory affairs, and sales and marketing,] both in and outside the U.S. We continue to face intense competition for qualified individuals from numerous multinational pharmaceutical companies, biotechnology companies, academic and other research institutions, as well as employers near our manufacturing and other facilities, which has and may continue to increase our labor costs.

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

We [removed: have experienced increased] [added: continue to experience] scrutiny on the pricing of current and potential diabetes, obesity, and Alzheimer's [added: disease] products due to payer concern over projected growth in these markets 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. [removed: presidential administration] [added: executive branch] 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 [added: in Medicare] effective in 2026.

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

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

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

We continue to experience additional pricing pressures, rebates, clawbacks, and other changes in reimbursement policies and programs resulting from [removed: the financial strain of the COVID-19 pandemic,] periods of uneven economic growth or downturns or uncertainty, and the emergence or escalation of, and responses to, international tension and conflicts.

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 [removed: Access,"] [added: Access] and [added: Certain Other Regulatory Developments" and] Item 8, "Financial Statements and Supplementary Data—Note 16: Contingencies."

[removed: from both market surveillance and post-marketing clinical studies of our products] [added: New safety] or [removed: those of our competitors] [added: efficacy data] may result in product label changes, or other measures that could reduce the product's market acceptance and result in declining sales.

Relatedly, safety or efficacy concerns raised about a product in the same [removed: class] [added: class, compounded] or [added: counterfeit versions of our products, or products] with the same mechanism of action as one of our products or product candidates could be imputed and have an adverse impact on the availability or commercial viability of our products or approval of product candidates.

- We derive a significant percentage of our total revenue from relatively few products and sell our products through [removed: increasingly] consolidated supply chain entities, which [removed: may subject] [added: subjects] us [removed: to, or exacerbate,] [added: to] various risks.

We derived direct product and/or [removed: alliance] [added: collaboration and other] revenues of more than [removed: $2] [added: $3] billion for each of [removed: Trulicity,] Mounjaro, Verzenio, [removed: Taltz and] [added: Trulicity, Zepbound,] Jardiance (including Glyxambi, Synjardy, and Trijardy [removed: XR)] [added: XR), and Taltz] that collectively accounted for [removed: 63] [added: 75] percent of our total revenues in [removed: 2023.][added: 2024.]

In particular, [removed: Trulicity] [added: Mounjaro, Trulicity,] and [removed: Mounjaro] [added: Zepbound] accounted for [removed: 36] [added: 48] percent of our total revenues in [removed: 2023] [added: 2024] and we expect [added: cardiometabolic health] products [removed: with GLP-1 receptor agonist activity, including the recently launched Zepbound,] to represent a significant and growing portion of our business, revenues, and prospects.

Loss of patent protection, changes in prescription rates, material product liability or pricing litigation, unexpected side effects or safety concerns, significant changes [added: or fluctuations] in demand, regulatory proceedings and investigations, negative publicity affecting doctor or patient confidence, pressure from existing or new competitive products, [added: pipeline developments by us or our competitors,] counterfeit and illegally compounded drugs, changes in labeling, pricing, and insufficient access, or [added: reimbursement, or actual or perceived] supply shortages or disruptions for these products or any of our other major products could materially impact our results of [removed: operations.][added: operations or result in significant and sudden declines or volatility in the trading price of our common stock and market capitalization.]

[removed: In addition, in the U.S., most of our products are distributed through wholesalers and if] [added: If] one of these significant wholesalers [removed: should encounter] [added: encounters] financial or other [removed: difficulties, it might decrease the amount] [added: difficulties or otherwise is unable to support distribution] of [removed: business the wholesaler does with us] [added: our products, it could cause disruption to our supply chain] or we might be unable to timely collect the amounts that the wholesaler owes us, which could negatively impact our results of operations.

Such stakeholders have also increasingly imposed utilization management tools to [removed: favor the use of generic products or otherwise] limit access to our products.

For non-biologic products, loss of exclusivity [removed: (whether by expiration of legal rights or by termination thereof as a consequence of litigation)] typically results in the entry of one or more generic competitors, leading to a rapid and severe decline in revenues, especially in the U.S. Generic pharmaceutical companies have in some cases introduced a generic product before resolution of any related patent litigation.

Moreover, patents relating to particular products, uses, formulations, or processes [removed: do] [added: may] not preclude other manufacturers from employing alternative processes or marketing alternative products or formulations that compete with our patented products.

See Item 7, "Management's Discussion and Analysis—Executive Overview—Other Matters—Patent [removed: Matters,"] [added: Matters"] and Item 1, "Business—Patents, Trademarks, and Other Intellectual Property Rights," for more details.

Given the limited duration of patent and data [removed: protection,] [added: protections,] the speed with which we develop products, complete clinical testing, receive regulatory [removed: approval,] [added: approvals,] supply commercial [removed: product] [added: products] to the market, and obtain public and private payer access are important factors in recouping our development costs and generating financial returns, particularly given regulatory and market dynamics that have and may continue to put pressure on pricing, exclusivity periods, and competition.

Delays in achieving these milestones in some cases [removed: limits] [added: may limit] our ability to capitalize on the innovative medicines that we develop or acquire.

Without strong intellectual property protection, we would be unable to generate the returns necessary to support our significant investments in research and development, as well as the other expenditures required to bring new [removed: drugs] [added: medicines] and indications to the market.

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

In some cases, the introduction of our own innovative products results in these adverse impacts for our preexisting products.

Our success depends on a market that is observant of intellectual property rights and regulatory requirements.

Developments that undermine that landscape can significantly impact our business and reputation.

For example, we have seen an increase in the production, marketing, and sale of counterfeit, misbranded, adulterated, and compounded incretins that could materially impact us.

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

If inadequately regulated, e-

commerce may increase the prevalence of dangerous counterfeit or diverted products and scams, potentially exposing patients to significant risks.

Our reputation and business could suffer harm as a result of counterfeit or diverted drugs sold under our brand name, which may also impact our business and financial results.

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.

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

In addition, in the U.S., most of our products are distributed through a limited number of wholesalers.

For example, Trulicity will lose significant patent and remaining data protections in the next few years.

Our success depends in part on our ability to obtain and defend patent rights and other intellectual property rights that are important to the commercialization of our products and product candidates.

The patent positions of pharmaceutical and biotechnology companies can be highly uncertain and often involve complex legal, scientific and factual questions.

Third parties may challenge, invalidate, or circumvent our patents and patent applications relating to our products, product candidates, and technologies.

In addition, our patent positions might not protect us against competitors with similar products or technologies because competing products or technologies may not be deemed to infringe our patents.

In recent years, U.S. government officials have proposed the exercise of "march-in-rights" and various other measures that, if enacted, could have a negative impact on our patent rights.

If any such proposals are adopted, our business and results of operations could be adversely affected.

A cybersecurity incident could also impose business costs through lost productivity, disruption to manufacturing, and costs to remediate and recover from the incident.

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

Many jurisdictions, including the U.S., the EU, and China have passed, or expect to pass, restrictions on international data transfers.

Compliance with current and future laws and regulations requires implementing potentially costly new controls and processes and may restrict certain core activities, including impacting our ability to carry out research and clinical studies across multiple geographies.

Further, cost inflation and global transportation and logistics

See, Item 1A, "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 Doing Business Internationally—Uneven economic growth or downturns or international trade and other global disruptions, geopolitical tensions, or disputes could adversely affect our business and operating results" for more details.

Supply and channel dynamics in some cases also contribute to variability in financial results for our products from period to period.

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.

To support anticipated demand for our current and prospective products, we have expanded relationships with contract manufacturing organizations and other third parties in recent periods.

Among other third-party providers, we, and the pharmaceutical industry generally, depend on China-based suppliers for portions of our supply chain.

U.S. officials are increasingly considering legislation or other actions that are intended to limit supply chain reliance on China, including the BIOSECURE Act.

In February 2025, the U.S. presidential administration imposed new tariffs on Chinese goods and China responded with tariffs on select U.S. goods.

If enacted, additional measures could result in supply disruptions or delays, increase costs more significantly, or invite further retaliatory measures, any of which could negatively impact our business.

See, Item 1A, "Risk Factors—Risks Related to Doing Business Internationally—Uneven economic growth or downturns or international trade and other global disruptions, geopolitical tensions, or disputes could adversely affect our business and operating results" for additional information.

Our use of AI or other emerging technologies could also exacerbate regulatory, cybersecurity and other significant risks.

Among other risks, the use of tariffs and other trade restrictions increase costs and may impact clinical trials or sales of our products, or otherwise complicate aspects of our business.

In February 2025, the U.S. presidential administration imposed new tariffs on Chinese goods and China responded with tariffs on select U.S. goods.

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

See Item 1A, "Risk Factors—Risks Related to Our Operations—Reliance on third-party relationships and outsourcing arrangements could adversely affect our business," for additional information.

There are

Our ability to attract and retain talent in our increasingly competitive environment is further complicated by evolving employment trends.

New safety or efficacy data

In addition, in December 2023, the U.S. presidential administration released a proposed framework that would permit the federal government to consider the price of a drug developed using federal funds as a factor in determining whether it may exercise "march-in rights" and license it to a third party to manufacture.

A comment period on the proposal runs through February 6, 2024, and we are not able to predict whether a final rule will be adopted in accordance with the proposed framework.

We also face challenges from the distribution of counterfeit and illegally compounded versions of our genuine drugs, including as related to our products with GLP-1 receptor agonist activity.

Counterfeits, and in some cases illegally compounded drugs, fraudulently claim to be, or claim to contain, genuine branded medicines.

Counterfeit and illegally compounded drugs may not have the same safety, quality, and effectiveness as approved drugs, and may pose serious health risks to patients.

undetected for significant periods of time.

In February 2024, we completed the implementation of a new global enterprise resource planning (ERP) system, which replaced our operating and financial systems, and we recently began our post-implementation activities.

We cannot assure that the ERP system and our post-implementation activities will be free of significant operating failures, service interruptions, or creation of additional vulnerabilities.

noncompliance.

For example, we have experienced challenges

in meeting demand for our incretin products in recent periods, partially due to the limited availability of competitor therapies, and expect tight supply to persist while additional manufacturing capacity is operationalized.

For example, in September 2023, the FDA issued a complete response letter for our lebrikizumab BLA for the treatment of moderate to severe atopic dermatitis.

In the letter, the FDA cited findings that arose during a multi-sponsor inspection of a third-party, contract manufacturing organization that included the monoclonal antibody drug substance for lebrikizumab.

These factors may undermine

adversely impacted when the U.S. dollar is strong compared to foreign currencies.

other parties.

These investigations, litigation, and claims have resulted in substantial expense and other significant consequences.

See Item 1, "Business—Government Regulation of Our Operations," for more details.

This section provides an overview of our financial results, [removed: late-stage pipeline developments,] [added: our clinical development pipeline,] and other matters affecting our company and [removed: the pharmaceutical] industry.

| Revenue | | | $ | [removed: 34,124.1] [added: 45,042.7] | | | | | $ | [removed: 28,541.4] [added: 34,124.1] | | | | | [removed: 20] [added: 32] | | |

| Net income | | | [removed: 5,240.4] [added: 10,590.0] | | | | | | [removed: 6,244.8] [added: 5,240.4] | | | | | | [removed: (16)] [added: 102] | | |

| Earnings per share - diluted | | | [removed: 5.80] [added: 11.71] | | | | | | [removed: 6.90] [added: 5.80] | | | | | | [removed: (16)] [added: 102] | | |

Revenue increased in [removed: 2023] [added: 2024] driven by increased volume [removed: and] [added: and, to a lesser extent,] higher realized prices.

Net income and earnings per share [removed: decreased] [added: increased] in [removed: 2023, driven] [added: 2024,] primarily [removed: by] [added: due to] higher [removed: acquired in-process research and development (IPR&D) charges and] [added: gross margin, partially offset by] increased research and development expenses, marketing, selling, and administrative expenses, and [removed: income taxes, partially offset by increased revenue.][added: asset impairment, restructuring, and other special charges.]

We currently have approximately [removed: 50] [added: 55] new medicine candidates in clinical development or under regulatory review, and a larger number of projects in the discovery phase.

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

| Tirzepatide (Mounjaro, [removed: Zepbound®)] [added: Zepbound)] | | | Obesity | | | Approved | | | Approved in the U.S. and the EU in [removed: 2023.] [added: 2023 and in Japan in 2024.] Phase [removed: III] [added: 3] trials are ongoing. | | | | | |

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

| Heart failure with preserved ejection fraction | | | [removed: Phase III] [added: Submitted] | | | [removed: Phase III trial is ongoing.] [added: Submitted in the U.S. and the EU in 2024.] | | | | | | | | |

| Morbidity and mortality in obesity | | | Phase [removed: III] [added: 3] | | | Phase [removed: III] [added: 3] trial is ongoing. | | | | | | | | |

| [removed: Obstructive sleep apnea (OSA)] [added: Parkinson's disease] | | | Phase [removed: III] [added: 2] | | | Granted U.S. Food and Drug Administration (FDA) Fast Track designation(2). Phase [removed: III] [added: 2] trial is ongoing. | | | | | | | | |

| Higher doses | | | Phase [removed: II] [added: 2] | | | Phase [removed: II] [added: 2] trial [removed: initiated in 2023.] [added: is ongoing.] | | | | | | | | |

| [removed: Nonalcoholic] [added: Metabolic dysfunction-associated] steatohepatitis | | | Phase [removed: II] [added: 2] | | | Announced in 2024 that a Phase [removed: II] [added: 2] trial met [removed: its] [added: the] primary endpoint. | | | | | | | | |

| [removed: Insulin Efsitora Alfa | | |] Type [removed: 1 and type] 2 diabetes | | | Phase [removed: III] [added: 3] | | | Phase [removed: III] [added: 3] trials are ongoing. | | | | | | [added: | | |]

| Orforglipron | | | Obesity | | | Phase [removed: III] [added: 3] | | | Phase [removed: III] [added: 3] trials [removed: initiated in 2023.] [added: are ongoing.] | | | | | |

| Type 2 diabetes | | | Phase [removed: III] [added: 3] | | | Phase [removed: III] [added: 3] trials initiated in [removed: 2023.] [added: 2024.] | | | | | | | | |

| [removed: Retatrutide | | |] Obesity, osteoarthritis, OSA | | | Phase [removed: III] [added: 3] | | | Phase [removed: III] [added: 3] trials [removed: initiated in 2023.] [added: are ongoing.] | | | | | | [added: | | |]

| Bimagrumab | | | Obesity | | | Phase [removed: II] [added: 2] | | | [removed: Acquired in the acquisition of Versanis Bio, Inc. (Versanis) in 2023.] Phase [removed: II] [added: 2] trial is ongoing. | | | | | |

| [removed: Lepodisiran] [added: Solbinsiran] | | | Cardiovascular disease | | | Phase [removed: II] [added: 2] | | | Phase [removed: II] [added: 2] trial is ongoing. | | | | | |

| Mazdutide | | | Obesity | | | Phase [removed: II] [added: 2] | | | Phase [removed: II] [added: 2] trial [removed: initiated in 2023.] [added: is ongoing.] | | | | | |

| [removed: Muvalaplin | | | Cardiovascular] [added: Pre-clinical Alzheimer's] disease | | | Phase [removed: II] [added: 3] | | | Phase [removed: II] [added: 3] trial is ongoing. | | | | | | [added: | | |]

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

| Eltrekibart | | | Hidradenitis suppurativa | | | Phase [removed: II] [added: 2] | | | Phase [removed: II] [added: 2] trial is ongoing. | | | | | |

| KV1.3 Antagonist | | | Psoriasis | | | Phase [removed: II] [added: 2] | | | Phase [removed: II] [added: 2] trial initiated in 2024. | | | | | |

| Ocadusertib [removed: (RIPK1 inhibitor)] | | | Rheumatoid arthritis | | | Phase [removed: II] [added: 2] | | | Phase [removed: II] [added: 2] trial [removed: initiated in 2023.] [added: is ongoing.] | | | | | |

| Donanemab [added: (Kisunla)] | | | Early Alzheimer's disease | | | [removed: Submitted] [added: Approved] | | | [removed: Submitted for approval] [added: Approved] in the [removed: U.S., the EU,] [added: U.S.] and Japan in [added: 2024. Submitted in the EU in] 2023. [removed: Granted FDA Breakthrough Therapy designation(4).] Phase [removed: III] [added: 3] trials are ongoing. | | | | | |

| Remternetug | | | Early Alzheimer's disease | | | Phase [removed: III] [added: 3] | | | Phase [removed: III trial is] [added: 3 trials are] ongoing. | | | | | |

| GBA1 Gene Therapy | | | Gaucher disease Type 1 | | | Phase [removed: II] [added: 2] | | | Phase [removed: II] [added: 2] trial [removed: initiated in 2023.] [added: is ongoing.] | | | | | |

| [removed: Parkinson's disease] [added: GRN Gene Therapy] | | | [added: Frontotemporal dementia | | |] Phase [removed: II] [added: 2] | | | Granted FDA Fast Track designation(2). Phase [removed: II] [added: 2] trial is ongoing. | | | | | | [removed: | | |]

| O-GlcNAcase Inh | | | Alzheimer's disease | | | [removed: Phase II] [added: Discontinued] | | | [added: In 2024,] Phase [removed: II] [added: 2] trial [removed: is ongoing.] [added: was discontinued based on clinical data readout.] | | | | | |

| OTOF Gene Therapy | | | Hearing loss | | | Phase [removed: II] [added: 2] | | | Phase [removed: II] [added: 2] trial initiated in 2024. | | | | | |

| P2X7 Inhibitor | | | Pain | | | Phase [removed: II] [added: 2] | | | Phase [removed: II] [added: 2] trials were [removed: completed.] [added: completed in 2023.] | | | | | |

| [removed: SSTR4 Agonist] [added: Mazisotine] | | | Pain | | | Phase [removed: II] [added: 2] | | | Phase [removed: II] [added: 2] trials are ongoing. | | | | | |

| Pirtobrutinib [removed: (Jaypirca®)] [added: (Jaypirca)] | | | Chronic lymphocytic leukemia | | | [removed: Approved(5)] [added: Approved(3)] | | | FDA granted accelerated [removed: approval(5)] [added: approval(3)] in the U.S. in 2023. [added: Submitted in the EU and Japan in 2024.] Phase [removed: III] [added: 3] trials are ongoing. | | | | | |

| Mantle cell lymphoma | | | [removed: Approved(5)] [added: Approved(3)] | | | FDA granted accelerated [removed: approval(5)] [added: approval(3)] in the U.S. in 2023. Approved in the EU in [removed: 2023. Submitted] [added: 2023 and] in Japan in [removed: 2023.] [added: 2024.] Phase [removed: III] [added: 3] trial is ongoing. | | | | | | | | |

| [removed: Imlunestrant | | |] Adjuvant breast cancer | | | Phase [removed: III] [added: 3] | | | Phase [removed: III] [added: 3] trial is ongoing. | | | | | | [added: | | |]

| Olomorasib | | | [added: 1L] KRAS [removed: G12C-mutant] [added: G12C+] NSCLC | | | Phase [removed: II] [added: 3] | | | Phase [removed: II] [added: 3] trial initiated in [removed: 2023.] [added: 2024.] | | | | | |

[removed: (3)] [added: (1)] In collaboration with Almirall, S.A. in Europe.

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

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

Clinical Development Pipeline

| Cardiometabolic Health | | | | | | | | | | | | | | |

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

| 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. | | | | | | | | |

| Retatrutide | | | Cardiovascular / renal outcomes | | | Phase 3 | | | Phase 3 trials initiated in 2024. | | | | | |

| Eloralintide | | | Obesity | | | Phase 2 | | | Phase 2 trial initiated in 2024. | | | | | |

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

| 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. | | | | | |

| Mirikizumab (Omvoh) | | | Crohn's disease | | | Approved | | | Approved in the U.S. and the EU in 2025. Submitted in Japan in 2024. | | | | | |

| Lebrikizumab(1) | | | AR (perennial allergens) | | | Phase 3 | | | Phase 3 trial initiated in 2024. | | | | | |

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

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

| Ulcerative colitis | | | 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 | | | | | | | | | | | |

| 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. | | | | | |

| Imlunestrant | | | ER+HER2- metastatic breast cancer | | | Submitted | | | Submitted in the U.S., the EU, and Japan in 2024. | | | | | |

See Item 1A, "Risk Factors—Risks Related to Our Business and Industry—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," for additional information.

The Medicare price HHS determines may impact the product's best price determination under the Medicaid Drug Rebate Program and the 340B Drug Pricing Program, potentially leading to a negative impact on both Medicaid and 340B prices.

In August 2024, HHS announced the government-set prices for these 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.

For example, the U.S. House of Representatives recently passed the BIOSECURE Act, which is under consideration in the U.S. Senate.

This legislation, if passed, could affect elements of the pharmaceutical supply chain; although as currently drafted we do not anticipate the bill would have a material impact on our business.

*Incretin Medicines*

At various times during 2024, demand for our incretin medicines exceeded production.

Supply and channel dynamics have also contributed to variability in quarter-over-quarter revenue growth rates for tirzepatide.

Tirzepatide supply currently exceeds demand in the U.S. Demand in launched markets remains dynamic, and increases or changes in demand, by dose or overall, as well as the complex supply chain, may result in periodic unavailability of certain presentations and dose levels at certain locations even when total tirzepatide supply can meet demand.

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

Production increases will continue, and additional capacity is expected to be operational over the next several years.

We have seen an increase in the production, marketing, and sale of counterfeit, misbranded, adulterated, and compounded incretins.

These practices may impact patient safety and undermine regulatory drug approval processes.

Lilly will continue to consider all options, including filing lawsuits where appropriate, to address unlawful practices and the patient safety risks of unapproved, untested, and manipulated drugs.

See Item 1, "Business—Government Regulation of Our Operations and Products” and Item 1A, "Risk —Risks Related to Our Business and Industry—We and our products face intense competition, including from multinational pharmaceutical companies, biotechnology companies, and lower-cost generic and biosimilar manufacturers, and such competition could have a material adverse effect on our business," for additional information.

Effective January 1, 2024, several EU and non-EU countries enacted legislation (known as "Pillar Two") that provided for a minimum level of taxation of multinational companies.

Continued regulatory focus on business combinations in our industry, including by the Federal Trade Commission and competition authorities in Europe and other jurisdictions, could continue to delay, jeopardize, or increase the costs of our business development activities and may negatively impact our consolidated financial position or results of operations.

| | | | 2023 | | | | | | 2022 | | | | | | | | |

The increase in revenue in 2023 was primarily driven by sales of Mounjaro®, Verzenio®, and Jardiance®, as well as the sales of the rights for the olanzapine portfolio, including Zyprexa®, and for Baqsimi®, partially offset by the absence of revenue from COVID-19 antibodies and lower sales of Alimta® following the entry of multiple generics in the first half of 2022.

Late-Stage Pipeline

| Diabetes, Obesity, and Other Cardiometabolic Diseases | | | | | | | | | | | | | | |

| Empagliflozin (Jardiance)(1) | | | Chronic kidney disease | | | Approved | | | Approved in the U.S. and the EU in 2023. Submitted in Japan in 2022. | | | | | |

| Type 2 diabetes | | | Phase II | | | Phase II trial was completed. | | | | | | | | |

| Volenrelaxin | | | Heart failure | | | Phase II | | | Phase II trial initiated in 2023. | | | | | |

| Lebrikizumab(3) (Ebglyss®) | | | Atopic dermatitis | | | Approved | | | Approved in the EU in 2023 and in Japan in 2024. Submitted in the U.S. in 2022. We received a complete response letter from the FDA in 2023. We anticipate regulatory action by the end of 2024. Phase III trials are ongoing. | | | | | |

| Mirikizumab | | | Crohn's Disease | | | Phase III | | | Announced in 2023 that a Phase III trial met the co-primary and all major secondary endpoints compared to placebo. Phase III trials are ongoing. | | | | | |

| DC-806 | | | Psoriasis | | | Phase II | | | Acquired in the acquisition of DICE Therapeutics, Inc. (DICE) in 2023. Phase II trial is ongoing. | | | | | |

| Peresolimab | | | Rheumatoid arthritis | | | Phase II | | | Phase II trial is ongoing. | | | | | |

| Ucenprubart | | | Atopic dermatitis | | | Phase II | | | Phase II trial initiated in 2023. | | | | | |

| Preclinical Alzheimer's disease | | | Phase III | | | Phase III trial is ongoing. | | | | | | | | |

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

| ER+HER2- metastatic breast cancer | | | Phase III | | | Phase III trial is ongoing. | | | | | | | | |

| Abemaciclib | | | Prostate cancer | | | Discontinued | | | In 2024, Phase III trials did not meet primary endpoints or were terminated for futility. | | | | | |

(1) In collaboration with Boehringer Ingelheim.

(4) Breakthrough Therapy designation is designed to expedite the development and review of potential medicines that are intended to treat a serious condition where preliminary clinical evidence indicates that the treatment may demonstrate substantial improvement over available therapy on a clinically significant endpoint.

Failure can occur at any point in the process, including in later stages after substantial investment.

As a result, most funds invested in research and development programs will not generate financial returns.

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 organizations that are commensurate with clinical data, 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 reaching healthcare professionals, including digitally given the increase in virtual engagements, or infringement of the patents or intellectual property rights of others.

We may also fail to allocate research and development resources efficiently, fail to pursue or invest sufficiently in product candidates or indications that may have been successful, or fail to optimally balance trial design, conduct, and speed to accomplish desired outcomes.

Regulatory agencies establish high hurdles for the efficacy and safety of new products and indications.

Delay, uncertainty, unpredictability, and inconsistency in drug approval processes across markets and agencies can result in delays in product launches, lost market opportunities, impairment of inventories, and other negative impacts.

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

Moreover, increased focus on business combinations across industries and jurisdictions can lead to impediments to the completion of business combinations.

*Product Supply*

We have faced challenges, and expect to continue to face challenges, meeting strong demand for our incretin products.

In the U.S., given the strong uptake of Mounjaro, the recent launch of Zepbound, and continuing demand for Trulicity®, we have experienced intermittent delays in fulfilling certain orders for incretin products.

Outside the U.S., we have implemented actions to manage demand amid tight supply, including measures to minimize impact to existing Trulicity patients.

We expect to continue to experience disruptions in our supply of incretin products and for demand and supply considerations to influence the timing of tirzepatide launches in new markets, if approved.

We anticipate tight supplies of our incretin products will persist while additional manufacturing capacity is operationalized.

We expect additional internal and contracted manufacturing capacity will become fully operational around the world in the next several years as part of our ongoing efforts to meet the significant demand for our incretin medicines.

For example, in 2023 we began production at our Research Triangle Park site in North Carolina and expect to continue significant capacity expansion over time as we increase production at this site and others.

In response to the OECD/G20 Inclusive Framework on Base Erosion and Profit Shifting (Framework), which set forth a two-pillar solution to reform the international tax framework, and the EU's adoption of Directive 2022/2523 (known as "Pillar Two") (Directive) within the EU to implement the Framework, multiple countries, both within and outside of the EU, have enacted legislation that provides for a minimum level of taxation of multinational companies.

The Directive required EU member states to enact legislation effective for years beginning on or after December 31, 2023.

For certain provisions within the Framework, the OECD published guidance during 2023 that extends the effective dates for enactment.

A bipartisan tax bill, the Tax Relief for American Families and Workers Act, was passed by the U.S. House of Representatives in January 2024.

The bill contains certain business tax provisions including the retroactive repeal for 2022 and 2023 and deferral of the requirement to capitalize U.S. research and development expenses for tax purposes that was a provision enacted in the 2017 Tax Act.

Uncertainty exists as to whether the bill will be enacted into law; however, if the bill is enacted as currently drafted, we would expect our effective tax rate for 2024 to be moderately higher, and a net discrete tax detriment in the quarter of enactment related to 2022 and 2023.

[removed: Most of the products that we sell today were discovered or developed by our own scientists, and our] [added: Our] long-term success depends on our ability to continually discover or acquire, develop, and commercialize innovative medicines.

Our products are sold in approximately [removed: 105] [added: 95] countries.

| [removed: Diabetes, Obesity and Other] Cardiometabolic [added: Health] products | | | [removed: *Basaglar®*] [added: *Basaglar*] | | | In collaboration with Boehringer Ingelheim, a long-acting human insulin analog for the treatment of diabetes. | | |

| [removed: *Humalog®,] [added: *Humalog,] Humalog Mix 75/25, Humalog U-100, Humalog U-200, Humalog Mix 50/50, insulin lispro, insulin lispro protamine, and insulin lispro mix 75/25* | | | Human insulin analogs for the treatment of diabetes. | | | | | |

| [removed: *Humulin*®,] [added: *Humulin*,] *Humulin 70/30, Humulin N, Humulin R,* and *Humulin U-500* | | | Human insulins of recombinant DNA origin for the treatment of diabetes. | | | | | |

| [removed: *Jardiance*®] [added: *Jardiance*] | | | In collaboration with Boehringer Ingelheim, for the treatment of type 2 diabetes; to reduce the risk of cardiovascular death in adult patients with type 2 diabetes and established cardiovascular disease; to reduce the risk of cardiovascular death and hospitalizations for heart failure in adults; and to reduce the risk of sustained decline in estimated glomerular filtration rate (eGFR), end-stage kidney disease, cardiovascular death and hospitalization in adults with chronic kidney disease (CKD) at risk of progression. | | | | | |

| [removed: *Mounjaro*®] [added: *Mounjaro*] | | | A glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1 receptor agonist, for the treatment of adults with type 2 diabetes in combination with diet and exercise to improve glycemic control. | | | | | |

| [removed: *Trulicit*y®] [added: *Trulicit*y] | | | For the treatment of type 2 diabetes in adults and pediatric patients 10 years of age and older; and to reduce the risk of major adverse cardiovascular events in adult patients with type 2 diabetes and established cardiovascular disease or multiple cardiovascular risk factors. | | | | | |

| [removed: *Zepbound*®] [added: *Zepbound*] | | | For the treatment of adults with obesity or overweight with [added: at least one] weight-related [removed: comorbidities as an adjunct] [added: comorbid condition in combination with a reduced-calorie diet and increased physical activity; and for the treatment of moderate] to [added: severe obstructive sleep apnea in adults with obesity in combination with] a reduced-calorie diet and increased physical activity [removed: (marketed] [added: (relevant indications marketed] under Mounjaro in [removed: the European Union (EU) and in] various [removed: other] markets outside the U.S.). | | | | | |

| [removed: *Cyramza*®] [added: Oncology products] | | | [added: *Cyramza* | | |] For use as monotherapy or in combination with another agent as a second-line treatment of advanced or metastatic gastric cancer or gastro-esophageal junction adenocarcinoma; in combination with another agent as a second-line treatment of metastatic [removed: NSCLC;] [added: non-small cell lung cancer (NSCLC);] in combination with another agent as a second-line treatment of metastatic colorectal cancer; as a monotherapy as a second-line treatment of hepatocellular carcinoma; and in combination with another agent as a first-line treatment of adult patients with metastatic NSCLC with activating epidermal growth factor receptor [added: (EGFR)] mutations. | | | [removed: | | |]

| [removed: *Erbitux*®] [added: *Erbitux*] | | | Indicated both as monotherapy and in combination with another agent for the treatment of certain types of colorectal cancers; and as monotherapy, in combination with chemotherapy, or in combination with radiation therapy for the treatment of certain types of head and neck cancers. | | | | | |

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

| [removed: *Retevmo*®] [added: *Retevmo*] | | | For the treatment of metastatic NSCLC with a rearranged during transfection (RET) gene fusion in adult patients; for the treatment of advanced metastatic medullary thyroid cancer with a RET mutation who require systemic therapy in adult and pediatric patients; for the treatment of advanced or metastatic thyroid cancer with a RET gene fusion in adult and pediatric patients who require systemic therapy and are radioactive iodine-refractory; and for the treatment of adult patients with locally advanced or metastatic solid tumors with a RET gene fusion who have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options. | | | | | |

| [removed: *Tyvyt*®] [added: *Tyvyt*] | | | In collaboration with Innovent Biologics, Inc., for the treatment of relapsed or refractory classic Hodgkin's lymphoma; for the first-line treatment of non-squamous NSCLC in combination with Alimta and another agent; for the first-line treatment of squamous NSCLC in combination with two other agents; for the first-line treatment of hepatocellular carcinoma in combination with another agent; for the first-line treatment of esophageal squamous cell carcinoma in combination with certain other agents; for the first-line treatment of gastric cancer in combination with two other agents; and, in combination with two other agents, for patients with [removed: epidermal growth factor receptor (EGFR)-mutated] [added: EGFR-mutated] non-squamous NSCLC that progressed after EGFR-tyrosine kinase inhibitor therapy, each in China. | | | | | |

| [removed: *Verzenio*®] [added: *Verzenio*] | | | For use as monotherapy or in combination with endocrine therapy for the treatment of HR+, HER2- metastatic breast [removed: cancer] [added: cancer,] and in combination with endocrine therapy for treatment of HR+, HER2-, node positive, early breast cancer at high risk of recurrence. | | | | | |

| Immunology products | | | [removed: *Ebglyss*®] [added: *Ebglyss*] | | | For the treatment of adult and adolescent patients 12 years or older with moderate to severe atopic dermatitis [removed: in Japan and,] [added: (in Europe,] in collaboration with Almirall [removed: S.A., in Europe.] [added: S.A.).] | | |

| [removed: *Olumiant*®] [added: *Olumiant*] | | | In collaboration with Incyte Corporation, for the treatment of adults with moderately to severely active rheumatoid arthritis after treatment with one or more tumor necrosis factor (TNF) blockers that did not work well enough or could not be tolerated; moderate to severe atopic dermatitis; severe alopecia areata; and for the treatment of hospitalized adults with COVID-19 who require supplemental oxygen, mechanical ventilation, or extracorporeal membrane oxygenation. | | | | | |

| [removed: *OmvohTM*] [added: *Omvoh*] | | | For the treatment of [removed: adults with] moderately to severely active ulcerative [removed: colitis.] [added: colitis in adults and for the treatment of moderately to severely active Crohn's disease in adults.] | | | | | |

| [removed: *Taltz*®] [added: *Taltz*] | | | For the treatment of adults and pediatric patients aged 6 years or older with moderate to severe plaque psoriasis; adults with active psoriatic arthritis; adults with ankylosing spondylitis; and adults with active non-radiographic axial spondyloarthritis. | | | | | |

| [removed: *Emgality®*] [added: Neuroscience products] | | | [added: *Emgality* | | |] For migraine prevention and the treatment of episodic cluster headache in adults. | | | [removed: | | |]

[removed: We promote] [added: Promotion of] our major products in the U.S. [removed: through] [added: includes engagement by employee or contracted] sales representatives [removed: who engage] with physicians and other healthcare professionals.

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

In [added: 2024,] 2023, [removed: 2022,] and [removed: 2021,] [added: 2022,] three wholesale distributors in the U.S.—McKesson Corporation, Cencora, [removed: Inc. (formerly AmerisourceBergen Corporation),] [added: Inc.,] and Cardinal Health, Inc.—each accounted for a significant percentage of our consolidated revenue.

For example, we and Boehringer Ingelheim have a global agreement to develop and commercialize a portfolio of diabetes products, including [removed: Trajenta®, Jentadueto®,] Jardiance, [removed: Glyxambi®, Synjardy®, Trijardy® XR, Basaglar,] [added: Glyxambi, Synjardy,] and [removed: Rezvoglar®.][added: Trijardy XR.]

Important competitive factors include effectiveness, safety, [removed: and] [added: availability,] ease of [removed: use;] [added: use, and overall 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, [added: indications,] and uses.

Most new products or uses that we introduce must compete with other branded, biosimilar, or generic products already on the market or that are later [removed: developed by competitors.][added: developed.]

When [removed: competitors introduce] new products, uses, or delivery systems with [removed: therapeutic] [added: therapeutic, convenience,] or cost [removed: advantages,] [added: advantages are introduced,] including by developing new modalities, our [added: existing] products become subject to decreased sales volumes, progressive price reductions, or both.

We believe our long-term competitive success depends on discovering and developing [removed: (either alone] or [removed: in collaboration with others) or] acquiring 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 environment.

There can be no assurance that our efforts will result in commercially successful products, and it is possible that our products [added: or indications] will be, or will become, uncompetitive from time to [removed: time as a result of products or uses developed by our competitors.][added: time.]

Globally, most governments have developed abbreviated regulatory pathways to approve biosimilars as follow-ons to innovator biologics, including the Biologics Price Competition and Innovation Act of 2009 (the BPCIA) in [added: the U.S. A number of biosimilars have been licensed under the BPCIA, as well as in Europe and Japan.]

Health plans, managed care organizations, pharmacy benefit managers, wholesalers, pharmacies, and other supply chain entities have [removed: been consolidating] [added: consolidated] into fewer, larger entities, thus enhancing their market power and importance.

The patent protection [added: generally] anticipated to be of most relevance to pharmaceuticals is provided by patents claiming the active ingredient (the compound patent) for our products, particularly those in major markets such as the U.S., major European countries, and Japan.

There is a five-year cap on any restoration, and no patent's [added: expiration date may be extended beyond 14 years from initial FDA approval.]

- Data package protection generally prohibits [removed: other manufacturers from submitting] regulatory [added: approval of other manufacturers'] applications for marketing approval [removed: in reliance] [added: if they rely] on the innovator company's regulatory submission data for the drug.

The base period is generally five years in the U.S. (12 years for new biologics under the BPCIA, subject to certain conditions), effectively 10 years in Europe, and eight years in [removed: Japan.][added: Japan, which can be extended to 10 years with qualifying pediatric studies.]

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

In addition to the patents and data protection identified below, we may hold patents on manufacturing processes, formulations, devices, or uses that [removed: extend exclusivity] [added: provide protection] beyond the [added: estimated] dates shown below.

For approved products, [added: estimated] dates include, where applicable, pending or granted patent term extensions.

| Therapeutic Area | | | Product | | | Protection | | | Territory | | | [removed: Expiry] [added: Estimated Expiry] Date | | |

| [removed: Diabetes, Obesity and] Cardiometabolic [added: Health] products | | | Jardiance | | | compound patent | | | U.S.* | | | [removed: 2028] [added: 2029] | | |

| *Kisunla* | | | For adults with early symptomatic Alzheimer's disease with confirmed amyloid pathology and with mild cognitive impairment or mild dementia stage of disease. | | | | | |

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.

We have launched, and continue to explore, new partnerships and tools, including through LillyDirect, to expand access to our medicines.

New initiatives may expose us to new risks or exacerbate existing risks.

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 each result in material harm to our

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

We maintain our own sales organizations in many countries.

We also often utilize third parties for commercial sales operations, some of which are engaged through distribution and promotion arrangements.

Barriers to reimbursable patient access in some cases include default payer coverage restrictions for our medicines.

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

Self-insured employers must opt in for coverage of these medicines.

Medicare and payers in various international markets also have not covered anti-obesity medicines for weight loss.

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

See also "—Competition—U.S. Private Sector Dynamics."

Generic Pharmaceuticals, Biosimilars, and Compounding

Compounding

In recent periods, we have seen an increase in the production, marketing, and sale of counterfeit, misbranded, adulterated, and compounded incretins.

These practices may impact patient safety, undermine regulatory drug approval processes, and present market risks.

If inadequately regulated, these practices could materially impact our business and reputation, including by creating consumer confusion or misperceptions about the safety and efficacy of our genuine products, diversion of potential sales, and potential net price erosion for our products.

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

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.

Where granted, estimated dates for approved products also reflect pediatric or orphan drug exclusivity.

The length of market exclusivity for our products can be difficult to predict with certainty because of the complex interaction between patent and regulatory forms of exclusivity and the inherent uncertainties regarding patent litigation.

There can be no assurance that a particular product will maintain market exclusivity for the duration of the estimated expiry or that exclusivity will be limited to that time frame.

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

| Therapeutic Area | | | Product | | | Protection | | | Territory | | | Estimated Expiry Date | | |

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

| major European countries | | | 2024 | | | | | | | | | | | |

| biologics data protection | | | U.S. | | | 2036 | | | | | | | | |

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

| Japan | | | 2030 | | | | | | | | | | | |

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

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

| Therapeutic Area | | | Product | | | Protection | | | Territory | | | Estimated Expiry Date | | |

| Japan | | | 2029 | | | | | | | | | | | |

| Kisunla | | | compound patent | | | U.S. | | | 2036 | | | | | |

| Japan | | | 2036 | | | | | | | | | | | |

| biologics data protection | | | U.S. | | | 2036 | | | | | | | | |

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

| Oncology products | | | *Alimta*® | | | For the first-line treatment, in combination with two other agents, of advanced non-small cell lung cancer (NSCLC) for patients with non-squamous cell histology and no epidermal growth factor receptor or anaplastic lymphoma kinase genomic tumor aberrations; for the first-line treatment, in combination with another agent, of advanced non-squamous NSCLC; for the second-line treatment of advanced non-squamous NSCLC; as monotherapy for the maintenance treatment of advanced non-squamous NSCLC in patients whose disease has not progressed immediately following chemotherapy treatment; and in combination with another agent for the treatment of malignant pleural mesothelioma. | | |

| Neuroscience products | | | *Cymbalta*® | | | For the treatment of major depressive disorder; diabetic peripheral neuropathic pain; generalized anxiety disorder; fibromyalgia; and chronic musculoskeletal pain due to chronic low back pain or chronic pain due to osteoarthritis. | | |

| Other products and therapies | | | *Cialis*® | | | For the treatment of erectile dysfunction and benign prostatic hyperplasia. | | |

| *Forteo*® | | | For the treatment of osteoporosis in men and postmenopausal women at high risk for broken bones or fracture and for glucocorticoid-induced osteoporosis in men and women. | | | | | |

We supplement our employee sales force with contract sales organizations to leverage our resources and reach additional patients in need.

In most countries in which we operate, we maintain our own sales organizations, but in some countries we market our products through third parties, some of which we have engaged through distribution and promotion arrangements.

the U.S. A number of biosimilars have been licensed under the BPCIA, as well as in Europe and Japan.

expiration date may be extended beyond 14 years from FDA approval.

| Japan | | | 2023 | | | | | | | | | | | |

| Japan | | | 2031 | | | | | | | | | | | |

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

- Lebrikizumab has been submitted for regulatory review in the U.S. for the treatment of moderate to severe atopic dermatitis.

- Pirtobrutinib has been submitted for regulatory review in Japan for the treatment of certain patients with relapsed or refractory mantle cell lymphoma.

In addition, in December 2023, the U.S. presidential administration released a proposed framework that would permit the federal government to consider the price of a drug developed using federal funds as a factor in determining whether it may exercise "march-in rights" and license it to a third party to manufacture.

A comment period on the proposal runs through February 6, 2024, and we are not able to predict whether a final rule will be adopted in accordance with the proposed framework.

Regulation of Products

For example, in 2023 we received complete response letters based on FDA observations made during inspections of manufacturing facilities rather than any issues related to efficacy or safety.

These resulted in certain delays in the approval of new products.

Emergency Use Authorizations

The Secretary of Health and Human Services may issue an Emergency Use Authorization (EUA) to authorize unapproved medical products, or unapproved uses of approved medical products, to be manufactured, marketed, and sold in the context of an actual or potential emergency that has been designated by the government.

For example, certain of our products were previously made available for the treatment of COVID-19 under respective EUAs.

An EUA terminates when the emergency determination underlying the EUA terminates, and EUAs can be revoked under other circumstances, the timing of which may occur unexpectedly or be difficult to predict.

Outside the U.S., the emergency use of medical products is subject to regulatory processes and requirements that vary and differ from those in the U.S.

In recent years, several jurisdictions have enhanced their laws and regulations in this area, increased their enforcement activities, and/or increased the level of cross-border coordination and information sharing.

Our approach to the rebates we offer to private payers that provide prescription drug benefits to seniors covered by Medicare may be impacted by the 2020 regulatory amendments to the anti-kickback statute's discount safe harbor, which have been stayed until at least January 1, 2032.

The majority of our revenue comes from products produced predominantly in our own facilities.

Our principal active ingredient manufacturing occurs at sites we own in the U.S., including Puerto Rico, and Ireland.

During 2023, commercial production commenced at our Research Triangle Park manufacturing site in Durham, North Carolina.

For example, we have experienced challenges in meeting strong demand for our incretin products in recent periods, partially due to the limited availability of competitor therapies, and expect tight supply to persist while additional manufacturing capacity is operationalized.

| Johna Norton | | | 57 | | | Executive Vice President, Global Quality (since 2017). Previously, Ms. Norton held various leadership roles with Lilly, including vice president, global quality assurance API manufacturing and product research and development. Ms. Norton has 33 years of service with Lilly. | | |

| Anne White | | | 55 | | | Executive Vice President and President, Lilly Neuroscience (since 2021). Previously, Ms. White held various leadership roles with Lilly, including senior vice president and president, Lilly Oncology, vice president of Portfolio Management, Chorus, and Next Generation Research and Development. Ms. White has 28 years of service with Lilly. | | |

| Ilya Yuffa | | | 49 | | | Executive Vice President and President, Lilly International (since 2021). Previously, Mr. Yuffa held various leadership roles with Lilly, including senior vice president and president, Lilly Bio-Medicines, vice president of U.S. Diabetes, general manager of Italy Hub, and vice president, global ethics and compliance officer since 2014. Mr. Yuffa has 27 years of service with Lilly. | | |

We believe the strength of our workforce significantly contributes to our financial performance and enables us to make life better for people around the world.

We believe our dedication to promoting diversity, equity, and inclusion within our company reflects our values and is a key driver of business success and growth.

Across all levels of our workforce, from the end of 2019 through the end of 2023, we have seen positive changes in representation for minority group members (MGM) in the United States and women globally.

In addition, 4 of 13 current members (approximately 31 percent) of our executive committee (which includes our CEO) are women and 3 are MGMs.

In addition, as of the filing of this Annual Report on Form 10-K, the company's 12-member board of directors includes five women and five members who are MGMs.

Our recruitment strategy focuses on opportunities to expand our pool of candidates to reach more candidates across a variety of dimensions, including but not limited to race, religion, sexual orientation, gender identity, national origin, veteran status, disability status, education, and experience.

We also strive to provide a diverse panel of interviewers for open positions.

We believe that recruiting in this way helps ensure that everyone will have an equal opportunity to advance their careers.

for the fiscal year ended December 31, [removed: 2023][added: 2024]

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: $398,291,000,000.][added: $769,792,000,000.]

Number of shares of common stock outstanding as of February [removed: 16, 2024: 950,164,452][added: 14, 2025: 948,169,999]

Portions of the Registrant's Proxy Statement for the [removed: 2024] [added: 2025] 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: 2023][added: 2024]

[removed: | [Part I](#i5830aedbd27d42838f753cdea13ed5a1_13) | | | | | | | | | | | | | | |][added: Part I]

| [Item [removed: 1.](#i5830aedbd27d42838f753cdea13ed5a1_16)] [added: 1.](#i34e43bfda1e54e63806263d62104c693_16)] | | | | | | [removed: [Business](#i5830aedbd27d42838f753cdea13ed5a1_16)] [added: [Business](#i34e43bfda1e54e63806263d62104c693_16)] | | | | | | [removed: [5](#i5830aedbd27d42838f753cdea13ed5a1_16)] [added: [5](#i34e43bfda1e54e63806263d62104c693_16)] | | |

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[removed: Forward-Looking Statements][added: *Forward-Looking Statements*]

- intense competition affecting our products, [removed: pipeline] [added: pipeline,] or industry;

- safety or efficacy concerns associated with our [added: or competitive] products;

- dependence on relatively few products or product classes for a significant percentage of our total revenue and [removed: an increasingly] [added: a] consolidated supply chain;

- the expiration of intellectual property protection for certain of our products and competition from generic and biosimilar [removed: products, and risks from the proliferation of counterfeit or illegally compounded] products;

- the use of artificial intelligence or other emerging technologies in various facets of our operations may exacerbate competitive, regulatory, litigation, [removed: cybersecurity] [added: cybersecurity,] and other risks;

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

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

- regulatory [added: oversight and] actions regarding our operations and products;

[removed: Part I][added: | [Part I](#i34e43bfda1e54e63806263d62104c693_13) | | | | | | | | | | | | | | |]

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

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

- significant and sudden declines or volatility in the trading price of our common stock and market capitalization;

- risks from the proliferation of counterfeit, misbranded, adulterated, or illegally compounded products;

Trademarks and Trade Names

All trademarks or trade names referred to in this Annual Report on Form 10-K are the property of the company, or, to the extent trademarks or trade names belonging to other companies are referenced in this Annual Report on Form 10-K, the property of their respective owners.

Solely for convenience, the trademarks and trade names in this Annual Report on Form 10-K are referred to without the ® and ™ symbols, but such references should not be construed as any indicator that the company or, to the extent applicable, their respective owners will not assert, to the fullest extent under applicable law, the company’s or their rights thereto.

We do not intend the use or display of other companies’ trademarks and trade names to imply a relationship with, or endorsement or sponsorship of us by, any other companies.

| [Part II](#i5830aedbd27d42838f753cdea13ed5a1_34) | | | | | | | | | | | | | | |

| [Part III](#i5830aedbd27d42838f753cdea13ed5a1_169) | | | | | | | | | | | | | | |

We have based our cybersecurity program on industry [removed: frameworks] [added: frameworks, including, among others, the U.S. National Institute of Standards and Technology Cybersecurity Framework,] with the goal of building enterprise resilience against an evolving landscape of cybersecurity threats and [removed: to respond] [added: responding] to cybersecurity threats as they materialize.

Our program includes monitoring, identification, assessment, and management components, as well as information [added: sharing] and escalation components designed to inform management and the board of directors of prospective risks and developments.

We describe risks faced by us from identified cybersecurity threats in Item 1A, "Risk Factors—Risks Related to Our [removed: Operations— Failure,] [added: 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 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" and] [added: problems",] "Risk Factors—Risks Related to Our Operations—Reliance on third-party relationships and outsourcing arrangements could adversely affect our [removed: business."][added: business", and "Risk Factors—Risks Related to Our Operations—Our use of artificial intelligence (AI) or other emerging technologies could adversely impact our business and financial results."]

In addition to providing regular updates to the CIDO and his staff, the CISO is a member of our Executive Information Security Governance function (EISG), which meets regularly and is [removed: also] composed of executive and senior leadership from a variety of functions, including information security, legal, finance, audit, and ethics and compliance to assess and manage cybersecurity developments and risks and our internal programs.

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

[removed: At December 31, 2023, we owned eleven] [added: We own several] production, distribution, and corporate administrative sites in the United States (U.S.), including Puerto Rico.

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

Major production sites include facilities in Ireland, France, Spain, Italy, [added: China,] and [removed: China.][added: Japan.]

In the U.S., our research and development facilities [removed: contain an aggregate of approximately 4.9 million square feet of floor area,] primarily [removed: consisting] [added: consist] of owned facilities located in [removed: Indianapolis] [added: Indiana] and [removed: smaller] leased sites [removed: primarily] in [removed: Boston, Massachusetts; San Diego, California; San Francisco, California; and] [added: California, Massachusetts,] New York, [removed: New York.][added: and Colorado.]

We own several production and distribution sites in Europe and Asia.

These facilities contain an aggregate of approximately 9.0 million square feet of floor area dedicated to production, distribution, and administration.

We also own production and distribution sites in Europe and Asia, containing an aggregate of approximately 4.7 million square feet of floor area.

[removed: Part II][added: Part II]

As of February [removed: 16, 2024,] [added: 14, 2025,] there were approximately [removed: 18,871] [added: 17,903] 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 [removed: fourth quarter] [added: three months] ended December 31, [removed: 2023:][added: 2024:]

During the three months ended December 31, [removed: 2023,] [added: 2024,] we [removed: did not repurchase any] [added: repurchased the remaining $1.98 billion of] shares under our $5.00 billion share repurchase program [added: that our board] authorized in May 2021.

The following graph compares the return on Lilly stock with that of the Standard & Poor's (S&P) 500 Stock Index and our peer group for the years [removed: 2019] [added: 2020] through [removed: 2023.][added: 2024.]

The graph assumes that, on the last business day of [removed: 2018,] [added: 2019,] a person invested $100 each in Lilly stock, the S&P 500 Stock Index, and the peer group's collective common stock.

Value of $100 Invested on Last Business Day of [removed: 2018] [added: 2019] Comparison of Five-Year Cumulative Total Shareholder Return Among Lilly, S&P 500 Stock Index, and Peer Group(1)

[removed: ][added: ]

| [removed: Dec-18] [added: Dec-19] | | | | | | $ | 100.00 | | | | | $ | 100.00 | | | | | $ | 100.00 | |

The peer group used for performance benchmarking aligns with the peer group used for executive compensation purposes for [removed: 2023.][added: 2024.]

| 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.

| 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 | | |

| October 2023 | | | — | | | $ | — | | — | | | $ | 2,500.0 | |

| November 2023 | | | — | | | — | | | — | | | 2,500.0 | | |

| December 2023 | | | — | | | — | | | — | | | 2,500.0 | | |

| Total | | | — | | | — | | | — | | | | | |

| Dec-19 | | | | | | 116.15 | | | | | | 118.31 | | | | | | 131.49 | | |

| Dec-20 | | | | | | 152.23 | | | | | | 121.00 | | | | | | 155.68 | | |

| Dec-21 | | | | | | 252.82 | | | | | | 145.23 | | | | | | 200.37 | | |

| Dec-22 | | | | | | 339.38 | | | | | | 158.70 | | | | | | 164.08 | | |

| Dec-23 | | | | | | 546.08 | | | | | | 158.45 | | | | | | 207.21 | | |

[removed: *Consolidated] [added: Consolidated] Statements of [removed: Operations*][added: Operations]

[removed: | ELI LILLY AND COMPANY AND SUBSIDIARIES] (Dollars in millions, except per-share data, and shares in thousands) [removed: | | | | | | Year Ended December 31 | | | | | | 2023 | | | | | | 2022 | | | | | | 2021 | | |]

| Revenue (Note 2) | | | | | | | | | | | | $ | [removed: 34,124.1] [added: 45,042.7] | | | | | $ | [removed: 28,541.4] [added: 34,124.1] | | | | | $ | [removed: 28,318.4] [added: 28,541.4] | |

| Cost of sales | | | | | | | | | | | | [removed: 7,082.2] [added: 8,418.3] | | | | | | [removed: 6,629.8] [added: 7,082.2] | | | | | | [removed: 7,312.8] [added: 6,629.8] | | |

| Research and development | | | | | | | | | | | | [removed: 9,313.4] [added: 10,990.6] | | | | | | [removed: 7,190.8] [added: 9,313.4] | | | | | | [removed: 6,930.7] [added: 7,190.8] | | |

| Marketing, selling, and administrative | | | | | | | | | | | | [removed: 7,403.1] [added: 8,593.8] | | | | | | [removed: 6,440.4] [added: 7,403.1] | | | | | | [removed: 6,431.6] [added: 6,440.4] | | |

| Acquired in-process research and development (Note 3) | | | | | | | | | | | | [removed: 3,799.8] [added: 3,280.4] | | | | | | [removed: 908.5] [added: 3,799.8] | | | | | | [removed: 970.1] [added: 908.5] | | |

| Asset impairment, restructuring, and other special charges (Note 5) | | | | | | | | | | | | [removed: 67.7] [added: 860.6] | | | | | | [removed: 244.6] [added: 67.7] | | | | | | [removed: 316.1] [added: 244.6] | | |

| Other—net, (income) expense (Note 18) | | | | | | | | | | | | [removed: (96.7)] [added: 218.6] | | | | | | [removed: 320.9] [added: (96.7)] | | | | | | [removed: 201.6] [added: 320.9] | | |

| | | | | | | | | | | | | [removed: 27,569.5] [added: 32,362.3] | | | | | | [removed: 21,735.0] [added: 27,569.5] | | | | | | [removed: 22,162.9] [added: 21,735.0] | | |

| Income before income taxes | | | | | | | | | | | | [removed: 6,554.6] [added: 12,680.4] | | | | | | [removed: 6,806.4] [added: 6,554.6] | | | | | | [removed: 6,155.5] [added: 6,806.4] | | |

| Income taxes (Note 14) | | | | | | | | | | | | [removed: 1,314.2] [added: 2,090.4] | | | | | | [removed: 561.6] [added: 1,314.2] | | | | | | [removed: 573.8] [added: 561.6] | | |

| Net income | | | | | | | | | | | | $ | [removed: 5,240.4] [added: 10,590.0] | | | | | $ | [removed: 6,244.8] [added: 5,240.4] | | | | | $ | [removed: 5,581.7] [added: 6,244.8] | |

| Basic | | | | | | | | | | | | $ | [removed: 5.82] [added: 11.76] | | | | | $ | [removed: 6.93] [added: 5.82] | | | | | $ | [removed: 6.15] [added: 6.93] | |

| Diluted | | | | | | | | | | | | $ | [removed: 5.80] [added: 11.71] | | | | | $ | [removed: 6.90] [added: 5.80] | | | | | $ | [removed: 6.12] [added: 6.90] | |

| Basic | | | | | | | | | | | | [removed: 900,181] [added: 900,605] | | | | | | [removed: 901,736] [added: 900,181] | | | | | | [removed: 906,963] [added: 901,736] | | |

| Diluted | | | | | | | | | | | | [removed: 903,284] [added: 904,059] | | | | | | [removed: 904,619] [added: 903,284] | | | | | | [removed: 911,681] [added: 904,619] | | |

[removed: *Consolidated] [added: Consolidated] Statements of Comprehensive [removed: Income (Loss)*][added: Income]

| Change in foreign currency translation gains (losses) | | | | | | | | | | | | [removed: (25.8)] [added: (424.2)] | | | | | | [removed: (248.1)] [added: (25.8)] | | | | | | [removed: 13.5] [added: (248.1)] | | |

| Change in net unrealized gains (losses) on available-for-sale securities | | | | | | | | | | | | [removed: 14.1] [added: (7.1)] | | | | | | [removed: (53.2)] [added: 14.1] | | | | | | [removed: (15.9)] [added: (53.2)] | | |

| Change in retirement benefit plans (Note 15) | | | | | | | | | | | | [removed: (776.5)] [added: 651.8] | | | | | | [removed: 616.9] [added: (776.5)] | | | | | | [removed: 2,699.4] [added: 616.9] | | |

| Change in net unrealized gains (losses) on cash flow hedges | | | | | | | | | | | | [removed: 109.5] [added: 79.3] | | | | | | [removed: 432.9] [added: 109.5] | | | | | | [removed: 151.6] [added: 432.9] | | |

| Other comprehensive income (loss) before income taxes | | | | | | | | | | | | [removed: (678.7)] [added: 299.8] | | | | | | [removed: 748.5] [added: (678.7)] | | | | | | [removed: 2,848.6] [added: 748.5] | | |

| Benefit (expense) for income taxes related to other comprehensive income (loss) | | | | | | | | | | | | [removed: 196.3] [added: (294.7)] | | | | | | [removed: (250.0)] [added: 196.3] | | | | | | [removed: (695.3)] [added: (250.0)] | | |

| Other comprehensive income (loss), net of tax (Note 17) | | | | | | | | | | | | [removed: (482.4)] [added: 5.1] | | | | | | [removed: 498.5] [added: (482.4)] | | | | | | [removed: 2,153.3] [added: 498.5] | | |

| Comprehensive income | | | | | | | | | | | | $ | [removed: 4,758.0] [added: 10,595.1] | | | | | $ | [removed: 6,743.3] [added: 4,758.0] | | | | | $ | [removed: 7,735.0] [added: 6,743.3] | |

[removed: *Consolidated] [added: Consolidated] Balance [removed: Sheets*][added: Sheets]

[removed: |] ELI LILLY AND COMPANY AND [removed: SUBSIDIARIES (Dollars in millions, shares in thousands) | | | | | | December 31 | | | | | | 2023 | | | | | | 2022 | | |][added: SUBSIDIARIES]

| Cash and cash equivalents (Note 7) | | | | | | | | | | | | $ | [removed: 2,818.6] [added: 3,268.4] | | | | | $ | [removed: 2,067.0] [added: 2,818.6] | |

| Short-term investments (Note 7) | | | | | | | | | | | | [removed: 109.1] [added: 154.8] | | | | | | [removed: 144.8] [added: 109.1] | | |

| Accounts receivable, net of allowances of [removed: $14.8 (2023)] [added: $14.9 (2024)] and [removed: $16.0 (2022)] [added: $14.8 (2023)] | | | | | | | | | | | | [removed: 9,090.5] [added: 11,005.7] | | | | | | [removed: 6,896.0] [added: 9,090.5] | | |

| Other receivables | | | | | | | | | | | | [removed: 2,245.7] [added: 2,269.7] | | | | | | [removed: 1,662.9] [added: 2,245.7] | | |

| Inventories (Note 6) | | | | | | | | | | | | [removed: 5,772.8] [added: 7,589.2] | | | | | | [removed: 4,309.7] [added: 5,772.8] | | |

| Prepaid expenses | | | | | | | | | | | | [removed: 5,540.8] [added: 8,340.5] | | | | | | [removed: 2,946.8] [added: 5,540.8] | | |

| Other current assets | | | | | | | | | | | | [removed: 149.5] [added: 111.4] | | | | | | [removed: 7.3] [added: 149.5] | | |

| Total current assets | | | | | | | | | | | | [removed: 25,727.0] [added: 32,739.7] | | | | | | [removed: 18,034.5] [added: 25,727.0] | | |

| Investments (Note 7) | | | | | | | | | | | | [removed: 3,052.2] [added: 3,215.9] | | | | | | [removed: 2,901.8] [added: 3,052.2] | | |

| Goodwill (Note 8) | | | | | | | | | | | | [removed: 4,939.7] [added: 5,770.3] | | | | | | [removed: 4,073.0] [added: 4,939.7] | | |

| Other intangibles, net (Note 8) | | | | | | | | | | | | [removed: 6,906.6] [added: 6,166.3] | | | | | | [removed: 7,206.6] [added: 6,906.6] | | |

| Deferred tax assets (Note 14) | | | | | | | | | | | | [removed: 5,477.3] [added: 8,000.6] | | | | | | [removed: 2,792.9] [added: 5,477.3] | | |

| | | | | | | | | | | | | Year Ended December 31, | | | | | | | | | | | | | | |

(Dollars in millions)

| | | | | | | | | | | | | Year Ended December 31, | | | | | | | | | | | | | | |

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

ELI LILLY AND COMPANY AND SUBSIDIARIES

(Dollars in millions, shares in thousands)

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

ELI LILLY AND COMPANY AND SUBSIDIARIES

| Net income (loss) | | | | | | | | | | | | | | | | | | | | | 10,590.0 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | (6.0) | | |

| Retirement of treasury shares | | | (2,964) | | | | | | (1.8) | | | | | | | | | | | | (2,498.2) | | | | | | | | | | | | | | | | | | (2,964) | | | | | | 2,500.0 | | | | | | | | |

| Other | | | | | | | | | | | | | | | | | | | | | (1.6) | | | | | | | | | | | | | | | | | | | | | | | | (16.8) | | | | | | (6.3) | | |

| Balance at December 31, 2024 | | | 947,903 | | | | | | $ | 592.4 | | | | | $ | 7,439.3 | | | | | $ | 13,545.0 | | | | | $ | (3,013.2) | | | | | $ | (4,321.9) | | | | | 365 | | | | | | $ | (49.5) | | | | | $ | 79.5 | |

ELI LILLY AND COMPANY AND SUBSIDIARIES

(Dollars in millions)

| | | | | | | | | | | | | Year Ended December 31, | | | | | | | | | | | | | | |

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

| Acquired in-process research and development | | | | | | | | | | | | 3,280.4 | | | | | | 3,799.8 | | | | | | 908.5 | | |

ELI LILLY AND COMPANY AND SUBSIDIARIES

See Note 19 for the segment disclosures as required by Topic 280, as amended by ASU 2023-07.

ASU 2024-03, *Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses,* requires disaggregation of specific expense categories in the notes to the financial statements and a qualitative description of the remaining expense amounts not separately disaggregated.

This standard is effective for annual reporting periods beginning after December 15, 2026, and requires prospective application with the option to apply it retrospectively.

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

| Cardiometabolic Health: | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| *Other cardiometabolic health* | | | | | | | | | 159.6 | | | | | | 175.0 | | | | | | 158.0 | | | | | | 353.1 | | | | | | 355.2 | | | | | | 338.9 | | |

| Total cardiometabolic health | | | | | | | | | 21,850.4 | | | | | | 14,780.8 | | | | | | 9,911.1 | | | | | | 7,670.5 | | | | | | 4,886.8 | | | | | | 4,553.7 | | |

| *Other oncology* | | | | | | | | | 610.9 | | | | | | 356.8 | | | | | | 713.4 | | | | | | 708.3 | | | | | | 473.6 | | | | | | 638.1 | | |

| *Other* | | | | | | | | | 251.4 | | | | | | 459.3 | | | | | | 546.8 | | | | | | 651.6 | | | | | | 662.9 | | | | | | 949.3 | | |

| Rest of world | | | | | | | | | | | | 4,271.4 | | | | | | 2,946.2 | | | | | | 2,852.0 | | |

We account for each arrangement as either a business combination or an asset acquisition in accordance with GAAP.

Business Combinations

*Manufacturing Facility Acquisition*

In May 2024, we acquired all outstanding membership interests of NexPharm Parent HoldCo, LLC and Isopro Holdings, LLC, which together own the assets of a manufacturing site in Wisconsin, for a purchase price of $924.7 million, net of cash acquired.

The facility is intended to further expand our global parenteral (injectable) product manufacturing network.

| Cash | | | $ | 2.3 | |

| Goodwill(1) | | | 816.5 | | |

| Property and equipment | | | 108.5 | | |

The results of operations attributable to this acquisition for the year ended December 31, 2024 were not material.

| Goodwill(1) | | | 853.9 | | |

| Morphic Holding, Inc. (Morphic) | | | MORF-057, inhibitor of α4β7 integrin for the treatment of inflammatory bowel disease | | | August 2024 | | | | | | Phase 2 | | | | | | $ | 2,548.5 | | | | | | | |

(2) In 2024, we discontinued development of this molecule in favor of another molecule in development.

| ELI LILLY AND COMPANY AND SUBSIDIARIES (Dollars in millions) | | | | | | Year Ended December 31 | | | | | | 2023 | | | | | | 2022 | | | | | | 2021 | | |

| Balance at January 1, 2021 | | | 957,077 | | | | | | $ | 598.2 | | | | | $ | 6,778.5 | | | | | $ | 7,830.2 | | | | | $ | (3,013.2) | | | | | $ | (6,496.4) | | | | | 487 | | | | | | $ | (55.7) | | | | | $ | 183.6 | |

| Net income | | | | | | | | | | | | | | | | | | | | | 5,581.7 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 3.4 | | |

| Retirement of treasury shares | | | (5,412) | | | | | | (3.4) | | | | | | | | | | | | (1,246.6) | | | | | | | | | | | | | | | | | | (5,412) | | | | | | 1,250.0 | | | | | | | | |

| Other | | | | | | | | | | | | | | | | | | | | | (5.1) | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | (11.4) | | |

| Debt extinguishment loss (Note 11) | | | | | | | | | | | | — | | | | | | — | | | | | | 405.2 | | |

Development milestone payments related to externally developed IPR&D projects, acquired directly in a transaction other than a business combination, were previously included in cash flows from operating activities in the consolidated statements of cash flows and are now included in purchases of IPR&D in cash flows from investing activities.

The reclassification resulted in an increase to net cash provided by operating activities and net cash used in investing activities of $501.3 million and $105.2 million in 2022 and 2021, respectively.

Early adoption is permitted.

This standard is effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024.

Early adoption is permitted, and the amendments should be applied retrospectively for all prior periods presented in the consolidated financial statements.

| Diabetes and obesity: | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| *Other diabetes and obesity* | | | | | | | | | 175.0 | | | | | | 158.0 | | | | | | 159.3 | | | | | | 355.2 | | | | | | 338.9 | | | | | | 384.8 | | |

| Total diabetes and obesity | | | | | | | | | 14,780.8 | | | | | | 9,911.1 | | | | | | 8,719.3 | | | | | | 4,886.8 | | | | | | 4,553.7 | | | | | | 4,468.8 | | |

| *Alimta®* | | | | | | | | | 72.9 | | | | | | 543.7 | | | | | | 1,233.9 | | | | | | 144.6 | | | | | | 384.0 | | | | | | 827.5 | | |

| *Other oncology* | | | | | | | | | 283.9 | | | | | | 169.7 | | | | | | 120.1 | | | | | | 329.0 | | | | | | 254.1 | | | | | | 210.7 | | |

| *Forteo®* | | | | | | | | | 335.5 | | | | | | 367.3 | | | | | | 441.6 | | | | | | 197.7 | | | | | | 245.8 | | | | | | 360.3 | | |

| *Cialis®* | | | | | | | | | 26.1 | | | | | | 35.2 | | | | | | 10.6 | | | | | | 355.3 | | | | | | 552.1 | | | | | | 707.9 | | |

| *Other* | | | | | | | | | 97.7 | | | | | | 144.2 | | | | | | 136.1 | | | | | | 109.9 | | | | | | 151.3 | | | | | | 233.9 | | |

| Other foreign countries | | | | | | | | | | | | 2,946.2 | | | | | | 2,852.0 | | | | | | 2,702.2 | | |

In December 2023, December 2022, and January 2021, we completed the acquisitions of POINT Biopharma Global Inc. (POINT), Akouos, Inc. (Akouos), and Prevail Therapeutics Inc. (Prevail), respectively.

These transactions, as further discussed below in Acquisitions of Businesses, were accounted for as business combinations under the acquisition method of accounting.

We also acquired assets in development in 2023, 2022, and 2021, which are further discussed below in Asset Acquisitions.

Acquisitions of Businesses

Our access to POINT information was limited prior to the acquisition.

As a consequence, we are in the process of determining fair values and tax bases of a significant portion of the assets acquired and liabilities assumed, including the identification and valuation of intangible assets and tax exposures.

The final determination of these amounts will be completed as soon as possible but no later than one year from the acquisition date.

The final determination may result in asset and liability fair values and tax bases that differ from the preliminary estimates and require changes to the preliminary amounts recognized.

| Goodwill(1) | | | 859.1 | | |

(3) See Note 7 for a discussion on the estimation of the CVR liability.

*Prevail Acquisition*

In January 2021, we acquired all shares of Prevail for a purchase price that included $22.50 per share in cash (or an aggregate of $747.4 million, net of cash acquired) plus one non-tradable CVR per share.

The CVR entitles Prevail stockholders up to an additional $4.00 per share in cash (or an aggregate of approximately $160 million) payable, subject to certain terms and conditions, upon the first regulatory approval of a Prevail product in one of the following countries: U.S., Japan, United Kingdom, Germany, France, Italy, or Spain.

To achieve the full value of the CVR, such regulatory approval must occur by December 31, 2024.

If such regulatory approval occurs after December 31, 2024, the value of the CVR will be reduced by approximately 8.3 cents per month until December 1, 2028, at which point the CVR will expire without payment.

Under the terms of the agreement, we acquired potentially disease-modifying AAV9-based gene therapies for patients with neurodegenerative diseases.

The acquisition established a new modality for drug discovery and development, extending our research efforts through the creation of a gene therapy program that is being anchored by Prevail's portfolio of assets.

The lead gene therapies in clinical development that we acquired were PR001 (GBA1 Gene Therapy) for patients with Parkinson's disease with GBA1 mutations and neuronopathic Gaucher disease and PR006 for patients with frontotemporal dementia with GRN mutations.

Both PR001 and PR006 were granted Fast Track designation from the U.S. Food and Drug Administration.

| Cash | | | $ | 90.5 | |

Our management, with the participation of David Ricks, president and chief executive officer, and [removed: Anat Ashkenazi,] [added: 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: 2023,] [added: 2024,] and concluded that they were effective.

Mr. Ricks and [removed: Ms. Ashkenazi] [added: 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: 2023] [added: 2024] 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: 2023.][added: 2024.]

[removed: You can find] [added: See Item 8 for] the full text of management's report and Ernst & Young's attestation [removed: report in Item 8.][added: report.]

During the fourth quarter of [removed: 2023,] [added: 2024,] 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.

We rely extensively on information systems and technology to manage our business, including integrated supply chain operations, and global consolidated financial results.

In February 2024, we completed the implementation of a new global enterprise resource planning (ERP) system, which replaced our operating and financial systems.

We recently began our post-implementation activities.

The ERP system is designed to accurately maintain our financial records, support integrated supply chain and other operational functionality, and provide timely information to our management team related to the operation of the business.

During the implementation and post-implementation activities, we have made, and will have to make, changes to certain of our processes and procedures, and we will evaluate quarterly whether the changes materially affect our internal control over financial reporting.

On November [removed: 16, 2023,] [added: 20, 2024,] Donald Zakrowski, senior vice president, finance, and chief accounting officer, adopted a sales plan (Plan).

The Plan calls for the sale of up to [removed: 3,150] [added: 4,000] shares of company common stock between March [removed: 11, 2024] [added: 13, 2025] and November [removed: 14, 2024] [added: 19, 2025] subject to the terms and conditions of the Plan.

[removed: Part III][added: Part III]

Information relating to our board of directors is found in our Definitive Proxy Statement, to be dated on or about March [removed: 22, 2024] [added: 21, 2025] (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 procedure 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.

Information on director compensation, executive compensation, and talent and compensation committee matters can be found in the Proxy Statement under "Governance - How We [removed: Operate] [added: Build] an Effective Board - [removed: Board Alignment -] Director Compensation," "- How We Operate an Effective Board - Board Structure - Meetings of the Board and Its Committees - Committees of the Board - Talent and Compensation Committee," "Compensation - Compensation Discussion and Analysis," "- Talent and Compensation Committee Matters," and "- Executive Compensation." Such information is incorporated in this Annual Report on Form 10-K by reference.

The following table presents information as of December 31, [removed: 2023] [added: 2024] 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: 49,082,012] [added: 48,827,102] | | |

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

(1) 2,396,006 shares are underlying outstanding equity awards.

| Total | | | — | | | — | | | 49,082,012 | | |

(1) 3,599,883 shares are underlying outstanding equity awards other than options.

- Consolidated Statements of Operations—Years Ended December 31, [added: 2024,] 2023, [removed: 2022,] and [removed: 2021][added: 2022]

- Consolidated Statements of Comprehensive [removed: Income (Loss)—Years] [added: Income—Years] Ended December 31, [added: 2024,] 2023, [removed: 2022,] and [removed: 2021][added: 2022]

- Consolidated Balance Sheets—December 31, [removed: 2023] [added: 2024] and [removed: 2022][added: 2023]

- Consolidated Statements of Shareholders' Equity—Years Ended December 31, [added: 2024,] 2023, [removed: 2022,] and [removed: 2021][added: 2022]

- Consolidated Statements of Cash Flows—Years Ended December 31, [added: 2024,] 2023, [removed: 2022,] and [removed: 2021][added: 2022]

| 4.1 | | | | | | [Indenture, dated February 1, 1991, between the Company and Deutsche Bank Trust Company Americas, as successor trustee to Citibank, N.A., as Trustee, incorporated by reference to Exhibit 4.1 to the Company's Registration Statement on Form S-3, Registration No. [removed: 333-186979](http://www.sec.gov/Archives/edgar/data/59478/000005947813000010/exhibit41-indenturedatedfe.htm)] [added: 333-186979](https://www.sec.gov/Archives/edgar/data/59478/000005947813000010/exhibit41-indenturedatedfe.htm)] | | |

| 4.2 | | | | | | [Tripartite Agreement, dated September 13, 2007, appointing Deutsche Bank Trust Company Americas as Successor Trustee under the Indenture listed in Exhibit 4.1, incorporated by reference to Exhibit 4.2 to the Company's Annual Report on Form 10-K for the year ended December 31, [removed: 2008](http://www.sec.gov/Archives/edgar/data/59478/000095015209001897/c49534exv4w2.htm)] [added: 2008](https://www.sec.gov/Archives/edgar/data/59478/000095015209001897/c49534exv4w2.htm)] | | |

| 4.3 | | | | | | [Description of the Company's Common [removed: Stock*](https://www.sec.gov/Archives/edgar/data/59478/000005947824000065/lly-20231231x10kexhibit43.htm)] [added: Stock](https://www.sec.gov/Archives/edgar/data/59478/000005947824000065/lly-20231231x10kexhibit43.htm)[, 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)] | | |

| 10.1 | | | | | | [Amended and Restated 2002 Lilly Stock [removed: Plan](http://www.sec.gov/Archives/edgar/data/59478/000005947818000188/lly-6302018x10qxexhibit101.htm)[(1)](http://www.sec.gov/Archives/edgar/data/59478/000005947818000188/lly-6302018x10qxexhibit101.htm)[,] [added: Plan(1),] incorporated by reference to Exhibit 10.1 to the Company's Quarterly Report on Form 10-Q for the quarter ended June 30, [removed: 2018](http://www.sec.gov/Archives/edgar/data/59478/000005947818000188/lly-6302018x10qxexhibit101.htm)] [added: 2024](https://www.sec.gov/Archives/edgar/data/59478/000005947824000187/lly-06302024x10qxexhibit101.htm)] | | |

| 10.3 | | | | | | [Form of Shareholder Value Award under the 2002 Lilly Stock [removed: Plan](https://www.sec.gov/Archives/edgar/data/59478/000005947824000065/lly-20231231x10kexhibit103.htm)[(1)](https://www.sec.gov/Archives/edgar/data/59478/000005947824000065/lly-20231231x10kexhibit103.htm)[*](https://www.sec.gov/Archives/edgar/data/59478/000005947824000065/lly-20231231x10kexhibit103.htm)] [added: 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)] | | |

| 10.4 | | | | | | [Form of Relative Value Award under the 2002 Lilly Stock [removed: Plan](https://www.sec.gov/Archives/edgar/data/59478/000005947824000065/lly-20231231x10kexhibit104.htm)[(1)](https://www.sec.gov/Archives/edgar/data/59478/000005947824000065/lly-20231231x10kexhibit104.htm)[*](https://www.sec.gov/Archives/edgar/data/59478/000005947824000065/lly-20231231x10kexhibit104.htm)] [added: 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)] | | |

| 10.5 | | | | | | [Form of Restricted Stock Unit Award under the 2002 Lilly Stock [removed: Plan](https://www.sec.gov/Archives/edgar/data/59478/000005947824000065/lly-20231231x10kexhibit105.htm)[(1)](https://www.sec.gov/Archives/edgar/data/59478/000005947824000065/lly-20231231x10kexhibit105.htm)[*](https://www.sec.gov/Archives/edgar/data/59478/000005947824000065/lly-20231231x10kexhibit105.htm)] [added: 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)] | | |

| [removed: 10.7] [added: 97] | | | | | | [removed: [The Lilly Deferred] [added: [Executive] Compensation [removed: Plan, as amended](https://www.sec.gov/Archives/edgar/data/59478/000005947814000078/lly-20131231x10kexhibit105.htm)[(1)](https://www.sec.gov/Archives/edgar/data/59478/000005947814000078/lly-20131231x10kexhibit105.htm)[,] [added: Recovery Policy](https://www.sec.gov/Archives/edgar/data/59478/000005947824000065/lly-20231231x10kexhibit97.htm)[,] incorporated by reference to Exhibit [removed: 10.5] [added: 97] to the [removed: Company's] [added: Company’s] Annual Report on Form 10-K for the year ended December 31, [removed: 2013](https://www.sec.gov/Archives/edgar/data/59478/000005947814000078/lly-20131231x10kexhibit105.htm)] [added: 2023](https://www.sec.gov/Archives/edgar/data/59478/000005947824000065/lly-20231231x10kexhibit97.htm)] | | |

| 10.8 | | | | | | [The Lilly Directors' Deferral Plan, as [removed: amended](https://www.sec.gov/Archives/edgar/data/59478/000005947817000183/lly-6302017x10qxexhibit10.htm)[(1)](https://www.sec.gov/Archives/edgar/data/59478/000005947817000183/lly-6302017x10qxexhibit10.htm)[, incorporated by reference to Exhibit 10 to the Company's Quarterly Report on Form 10-Q for the quarter ended June 30, 2017](https://www.sec.gov/Archives/edgar/data/59478/000005947817000183/lly-6302017x10qxexhibit10.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)[)](https://www.sec.gov/Archives/edgar/data/59478/000005947825000067/lly-20241231x10kexhibit108.htm)[*](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)] [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)[,](https://www.sec.gov/Archives/edgar/data/59478/000005947824000065/lly-20231231x10kexhibit1010.htm) [incorporated by reference](https://www.sec.gov/Archives/edgar/data/59478/000005947824000065/lly-20231231x10kexhibit1010.htm) [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)] | | |

| 21 | | | | | | [List of [removed: Subsidiaries*](https://www.sec.gov/Archives/edgar/data/59478/000005947824000065/lly-20231231x10kexhibit21.htm)] [added: Subsidiaries*](https://www.sec.gov/Archives/edgar/data/59478/000005947825000067/lly-20241231x10kexhibit21.htm)] | | |

| 23 | | | | | | [Consent of Independent Registered Public Accounting [removed: Firm*](https://www.sec.gov/Archives/edgar/data/59478/000005947824000065/lly-20231231x10kexhibit23.htm)] [added: Firm*](https://www.sec.gov/Archives/edgar/data/59478/000005947825000067/lly-20241231x10kexhibit23.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/59478/000005947824000065/lly-20231231x10kexhibit311.htm)] [added: Officer*](https://www.sec.gov/Archives/edgar/data/59478/000005947825000067/lly-20241231x10kexhibit311.htm)] | | |

| 31.2 | | | | | | [Rule 13a-14(a) Certification [removed: of Anat Ashkenazi,] [added: 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)[,] Executive Vice President and Chief Financial [removed: Officer*](https://www.sec.gov/Archives/edgar/data/59478/000005947824000065/lly-20231231x10kexhibit312.htm)] [added: Officer*](https://www.sec.gov/Archives/edgar/data/59478/000005947825000067/lly-20241231x10kexhibit312.htm)] | | |

| 32 | | | | | | [Section 1350 [removed: Certification*](https://www.sec.gov/Archives/edgar/data/59478/000005947824000065/lly-20231231x10kexhibit32.htm)] [added: Certification*](https://www.sec.gov/Archives/edgar/data/59478/000005947825000067/lly-20241231x10kexhibit32.htm)] | | |

Long-term debt instruments under which the total amount of securities authorized does not exceed 10 percent of our consolidated [added: assets are not filed as exhibits to this Annual Report.]

We will furnish a copy of these agreements to the Securities and Exchange [added: Commission upon request.]

| 10.7 | | | | | | [The Lilly Deferred Compensation Plan, as 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) | | |

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

| | | | | | | | | |

| 97 | | | | | | [Executive Compensation Recovery Policy*](https://www.sec.gov/Archives/edgar/data/59478/000005947824000065/lly-20231231x10kexhibit97.htm) | | |

assets are not filed as exhibits to this Annual Report.

Commission upon request.

Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below on February [removed: 21, 2024] [added: 19, 2025] by the following persons on behalf of the Registrant and in the capacities indicated.

| /s/ [removed: Anat Ashkenazi] [added: Lucas Montarce] | | | | | | Executive Vice President and Chief Financial Officer (principal financial officer) | | |

February 19, 2025

| LUCAS MONTARCE | | | | | | | | |

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

| JON MOELLER | | | | | | | | |

| | | | | | | | | |

| | | | | | | | | |

February 21, 2024

| ANAT ASHKENAZI | | | | | | | | |

| /s/ Marschall Runge, M.D., Ph.D. | | | | | | Director | | |

| MARSCHALL RUNGE, M.D., Ph.D. | | | | | | | | |

| /s/ Karen Walker | | | | | | Director | | |

| KAREN WALKER | | | | | | | | |

Trademarks Used In this Annual Report on Form 10-K

Trademarks or service marks owned by Eli Lilly and Company or its affiliates, when first used in each item of this Annual Report on Form 10-K, appear with an initial capital and are followed by the symbol ® or ™, as applicable.

In subsequent uses of the marks in the item, the symbols may be omitted.

Actos® is a registered trademark of Takeda Pharmaceutical Company Limited.

Baqsimi® is a registered trademark of Amphastar Pharmaceuticals, Inc.

Glyxambi®, Jardiance®, Jentadueto®, Synjardy®, Trajenta®, and Trijardy® are trademarks of Boehringer Ingelheim International GmbH.

Tyvyt® is a registered trademark of Innovent Biologics (Suzhou) Co., Ltd.

Qbrexza® is a registered trademark of Journey Medical Corporation.

Zyprexa® is a registered trademark of Cheplapharm Arzneimittel GmbH.