•~~Cyramza is protected by a compound patent and biologics data protection (2026).~~

•~~Emgality is protected by a compound patent (2033) and biologics data protection (2030).~~

•

Therapeutic Area

Product

Protection

Territory

Expiry Date

Immunology products

Ebglyss

compound patent

major European countries

2024

Japan

2024

data protection

major European countries

2033

Japan

2034

Olumiant

compound patent

U.S.

2032

major European countries

2032

Japan

2033

data protection

major European countries

2027

Japan

2025

Omvoh

compound patent

U.S.

2037

major European countries

2038

Japan

2039

biologics data protection

U.S.

2035

data protection

major European countries

2033

Japan

2031

Taltz

compound patent

U.S.

2030

major European countries

2031

Japan

2030

biologics data protection

U.S.

2028

data protection

major European countries

2027

Japan

2024

Neuroscience products

Emgality

compound patent

U.S.

2033

major European countries

2033

Japan

2035

biologics data protection

U.S.

2030

data protection

major European countries

2028

Japan

2029

Reyvow®

compound patent

U.S.

2030

Japan

2028

data protection

major European countries

2032

Japan

2032

* Jardiance and the related combination product, ~~Glyxambi, is protected by a compound patent (2028).~~

•~~Jaypirca is protected by a compound patent (2037) and by data protection (2028).~~

•~~Mounjaro is protected by a compound patent (2036) and by data protection (2027).~~

•~~Olumiant is protected by a compound patent (2032).~~

•~~Retevmo is protected by a compound patent (2037) and by data protection (2025).~~

•~~Reyvow~~® ~~is protected by a compound patent (2030).~~

•~~Taltz is protected by a compound patent (2030) and by biologics data protection (2028).~~

•~~Trulicity is protected by a compound patent (2027) and by biologics data protection (2027).~~

•~~Verzenio is protected by a compound patent (2031).~~

~~Outside the U.S., important patent protection or data protection includes:~~

•~~Baqsimi~~® ~~is protected by data protection in Japan (2026).~~

•~~Cyramza is protected by a compound patent (2028) and by data protection (2024) in major European countries, and by a compound patent (2026) and by data protection (2023) in Japan.~~

•~~Emgality is protected by a compound patent (2033) and by data protection (2028) in major European countries, and by a compound patent (2035) and by data protection (2029) in Japan.~~

•~~Jardiance is protected by a compound patent in major European countries (2029) and Japan (2030).~~

•~~Mounjaro is protected by a compound patent in major European countries (2037) and Japan (2040).~~

•~~Olumiant is protected by a compound patent (2032) and by data protection (2027) in major European countries, and by a compound patent (2033) and by data protection (2025) in Japan.~~

•~~Retevmo is protected by a compound patent (2037) and by data protection (2031) in major European countries, and by a compound patent (2038) and by data protection (2029) in Japan.~~

•~~Reyvow is protected by data protection (2032) in major European countries, and a compound patent (2028) and by data protection (2032) in Japan.~~

•~~Taltz is protected by a compound patent (2031) and data protection (2027) in major European countries and a compound patent (2030) and data protection (2024) in Japan.~~

•~~Trulicity is protected by a compound patent (2029) and by data protection (2024) in major European countries and by a compound patent (2029) and by data protection (2023) in Japan.~~

•~~Verzenio is protected by a compound patent (2033) and data protection (2028) in major European countries and by a compound patent (2034) and data protection (2026) in Japan.~~Glyxambi.

The following product candidates are the most relevant that are currently under regulatory review. Upon approval, we expect relevant compound patent and data protections to apply:

•Donanemab has been submitted for regulatory review in the U.S., the EU and Japan for the treatment of early Alzheimer's disease. ~~In January 2023, the FDA issued a complete response letter for our accelerated approval submission. Phase III trials are ongoing.~~

•Lebrikizumab has been submitted for regulatory review in the U.S. ~~and Europe~~ for the treatment of moderate to severe atopic dermatitis.

•~~Mirikizumab~~Pirtobrutinib has been submitted for regulatory review in ~~the U.S., Europe, and~~ Japan for the treatment of ~~ulcerative colitis.~~certain patients with relapsed or refractory mantle cell lymphoma.

Worldwide, we sell all of our major products under trademarks consisting of our product names, logos, and unique ~~product~~product appearances ~~(e.g., the appearance of our Trulicity autoinjector)~~ that we consider in the aggregate to be important to our operations. Trademark protection varies throughout the ~~world, with protection continuing in some countries as long as the mark is used, and in other countries as long as it is registered. Registrations are normally for fixed but renewable terms.~~world. Trademark protection typically extends beyond the patent and data protection for a product.

We also rely in some circumstances on trade secrets and other unpatented know-how. We seek to protect our confidential information in part through confidentiality agreements with our employees, corporate partners, collaborators, and vendors. These agreements may be breached, and we cannot be certain that we have adequate remedies. If our trade secrets or confidential information become known or are independently discovered by competitors, or if we enter into disputes over ownership of inventions, our business and results of operations could be adversely affected.

Patent Licenses and Collaborations

~~Most~~Some of our ~~major~~ products are ~~not~~ subject to significant license and collaboration agreements. For information on our license and collaboration agreements, see Item 8, "Financial Statements and Supplementary Data—Note 4: Collaborations and Other Arrangements."

Patent Challenges

In the U.S., the Drug Price Competition and Patent Term Restoration Act of 1984, commonly known as the Hatch-Waxman Act, authorizes the FDA to approve generic versions of innovative pharmaceuticals (other than ~~biologics, which are discussed below in more detail)~~biologics) when the generic manufacturer ~~has not conducted safety and efficacy studies but~~ files an Abbreviated New Drug Application (ANDA). In an ANDA, the generic manufacturer must demonstrate only "pharmaceutical equivalence" and "bioequivalence" between the generic version and the New Drug Application (NDA)-approved-drug, not safety and efficacy. Establishing pharmaceutical equivalence and bioequivalence is generally straightforward and inexpensive for the generic company.

Absent a patent challenge, the FDA cannot approve an ANDA until after certain of the innovator's patents expire. However, after the innovator has marketed its product for four years, a generic manufacturer may file an ANDA alleging that ~~one or more of~~ the ~~patents~~patent(s) listed in the innovator's ~~NDA~~New Drug Application (NDA) are invalid, unenforceable or not infringed. This allegation is commonly known as a "Paragraph IV certification." If the innovator responds by filing suit against the generic manufacturer, the FDA is then prohibited from approving the generic company's application for a 30-month period (which can be shortened or extended by the trial court judge hearing the patent challenge). If one or more of the NDA-listed patents are challenged, the first filer(s) of a Paragraph IV certification may be entitled to a 180-day period of market exclusivity over all other generic manufacturers.

Generic manufacturers use ~~Paragraph IV certifications~~this process extensively to challenge patents on innovative pharmaceuticals. In addition, generic companies have shown willingness to launch "at risk," i.e., after receiving ANDA approval but before final resolution of their patent challenge.

Under the BPCIA, the FDA cannot approve an application for a biosimilar product until data protection expires, 12 years after initial marketing approval of the innovator biologic, and an application may not be submitted until four years following the date the innovator biologic was first approved. However, the BPCIA does provide a mechanism for a prospective biosimilar competitor to challenge the validity of an innovator's patents as early as four years after initial marketing approval of the innovator biologic.

The patent litigation scheme under the BPCIA, and the BPCIA itself, is complex and continues to be interpreted and implemented by the FDA, as well as by courts. Courts have held that biosimilar applicants are not required to engage in the BPCIA patent litigation scheme and patent holders retain the right to bring suit under normal patent law procedures if a biosimilar applicant attempts to commercialize a product prior to patent expiration. Further, in the U.S., the increased likelihood of generic and biosimilar challenges to innovators' intellectual property has increased the risk of loss of innovators' market exclusivity. See also "—Competition—Biosimilars." In addition, there is a procedure in U.S. patent law, known as inter partes review (IPR), which allows any member of the public to file a petition with the USPTO seeking the review of any issued U.S. patent for validity. IPRs are conducted before Administrative Patent Judges in the USPTO using a lower standard of proof than used in federal district ~~court. In addition, the~~court and challenged patents are not accorded the presumption of ~~validity as they are in federal district court.~~validity. Generic drug companies and even some investment firms have engaged in the IPR process in attempts to invalidate our patents. ~~The use of IPR proceedings after~~In addition, in December 2023, the ~~institution of litigation pursuant~~U.S. presidential administration released a proposed framework that would permit the federal government to consider the BPCIA or Hatch-Waxman Act is currently a topic of debate among legislators. We have also observed, and may continue to observe, changes at the Patent Trial and Appeal Board (PTAB), including with respect to the PTAB's policy to discretionarily deny an otherwise meritorious petition for IPR in lightprice of a ~~concurrent district court proceeding. See Item 1A, "Risk Factors—Risks Related~~drug developed using federal funds as a factor in determining whether it may exercise "march-in rights" and license it to ~~Our Business—Our long-term success depends~~a third party to manufacture. A comment period on ~~intellectual property protection; if our intellectual property rights~~the proposal runs through February 6, 2024, and we are ~~invalidated, circumvented, or weakened, our business~~not able to predict whether a final rule will be ~~adversely affected."~~

adopted in accordance with the proposed framework.

Outside the U.S., the legal doctrines and processes by which pharmaceutical patents can be challenged vary widely. In recent years, we have experienced an increase in patent challenges from generic manufacturers in many countries outside the U.S.

For more information on ~~administrative~~patent challenges and litigation involving our intellectual property rights, see Item 1A, "Risk Factors—Risks Related to Our Business—Our long-term success depends on intellectual property protection; if our intellectual property rights are invalidated, circumvented, or weakened, our business will be adversely affected." and Item 8, "Financial Statements and Supplementary Data—Note 16: Contingencies."

Government Regulation of Our Operations

Our operations are regulated extensively by numerous ~~national, state, and local~~government agencies.

Regulation of Products

The lengthy process of laboratory and clinical testing, data analysis, manufacturing development, and regulatory review necessary for governmental approvals of our products is extremely costly and can significantly delay product introductions and revenue generation. In addition, our operations are subject to complex federal, state, local, and foreign laws and regulations concerning relationships with healthcare providers and suppliers, pricing and reimbursement for our products, the environment, occupational health and safety, data privacy and security, and other matters. Evolving regulatory priorities have intensified governmental scrutiny of our operations and those of other healthcare intermediaries, including with respect to current Good Manufacturing Practices (cGMP), quality assurance, and similar regulations. Regulatory oversight of the pharmaceutical industry entails judgment and interpretation, which can result in inconsistent administration of laws and regulations by health authorities. Compliance with the laws and regulations affecting the manufacture and sale of current products and the discovery, development, and introduction of new products and uses has and will continue to require substantial effort, expense, and capital investment.

Of particular importance to our business is regulation by the FDA in the U.S. Pursuant to laws and regulations that include the Federal Food, Drug, and Cosmetic Act (FDCA), the FDA has jurisdiction over all of our products and devices in the U.S. and administers requirements covering the testing, safety, effectiveness, manufacturing, quality control, distribution, labeling, marketing, promotion, advertising, dissemination of information, and post-marketing surveillance of those products and devices. The FDA holds broad discretion under the FDCA and other statutes to interpret the conditions and evidence necessary for timely approval of our drugs and devices.

Following approval, our products remain subject to regulation by various government and regulatory agencies in connection with labeling, import, export, sale, storage, recordkeeping, advertising, promotion, and safety reporting. We conduct extensive post-marketing surveillance of the safety of the products we ~~sell.~~sell and comply with notification requirements related to safety and efficacy, product supply, and other aspects of our products and operations. The FDA may withdraw approval of a product if compliance with regulatory requirements and standards is not maintained or if problems occur after a product reaches the ~~market.~~market, including as may be identified through market surveillance or third-party studies involving our products. The FDA may also mandate labeling changes to products at any point in a product's life cycle based on new safety information or as part of a labeling change to a particular class of products. In addition, the FDA strictly regulates marketing, labeling, advertising, and promotion of products ~~that are placed on the market.~~to prescribers and patients. Pharmaceutical products may be promoted only for approved indications and in accordance with the provisions of the approved label. The FDA and other agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses.

Outside the U.S., our products and operations are subject to similar regulatory requirements, notably by the EMA in Europe, the Ministry of Health, Labor and Welfare in Japan, and the National Medical Products Administration in China. Specific regulatory requirements vary from country to country. Regulatory and compliance requirements, as well as approval processes outside the U.S., may differ from those in the U.S. and may involve additional costs, uncertainties, and risks.

The FDA and other regulatory agencies outside the U.S. extensively regulate all aspects of manufacturing quality for pharmaceuticals under their cGMP regulations. Regulators assess compliance with these regulations by inspecting the equipment, facilities, laboratories, and processes used in the manufacturing and testing of our products prior to marketing approval with periodic reinspection thereafter; this may include inspection of our third-party business partners. We make substantial investments of capital and operating expenses to implement comprehensive, company-wide quality systems and controls in our manufacturing, product development, and process development operations in an effort to maintain sustained compliance with cGMP and other regulations. ~~However,~~Nonetheless, manufacturing quality and other aspects of pharmaceutical regulatory compliance is heavily scrutinized and results in ~~the event we fail to adhere to these requirements, we become subject to potential~~ government investigations, regulatory and legal actions, product recalls and seizures, fines and penalties, interruption of production leading to product shortages, import bans or denials of import certifications, delays or denials in new product approvals or line extensions or supplemental approvals of current products pending resolution of ~~the~~any issues, ~~and reputational harm,~~ any of which ~~would~~have and could adversely affect our ~~business.~~business and reputation. Certain of our products, devices and components are manufactured by third parties, and their failure to comply with these regulations has and could in the future adversely affect us, including through failure to supply product to us or delays in approvals of new products or indications. 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.

Any determination by the FDA or other regulatory authorities of manufacturing or other deficiencies could adversely affect our business and reputation.

~~We are also subject~~ For more information on product regulation challenges, see Item 1A, "Risk Factors—Risks Related to ~~a variety of federal, state, local,~~Our Operations—Reliance on third-party relationships and ~~foreign environmental, health and safety, and other laws and regulations that may~~outsourcing arrangements could adversely affect our ~~research, development or production efforts.~~

business."

Emergency Use Authorizations

The Secretary of Health and Human Services may issue an ~~EUA~~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.

The COVID-19 pandemic has been designated as a national emergency in the U.S. On the basis of such determination, the FDA granted EUAs for bamlanivimab and etesevimab administered together, certain COVID-19-related uses of baricitinib, and bebtelovimab, and similar actions have been taken by other regulators in certain jurisdictions outside the U.S. However, the FDA has revised, and may in the future further revise, these EUAs in response to the changing conditions of the COVID-19 pandemic, such as the prevalence of variants against which our antibodies have varying degrees of efficacy. In May and November 2022, respectively, the FDA announced that bamlanivimab and etesevimab are, and bebtelovimab is, not currently authorized for emergency use for any U.S. region.

Other Laws and Regulations

The marketing, promotional, and pricing practices of pharmaceutical manufacturers, as well as the manner in which manufacturers interact with purchasers, prescribers, and patients, are subject to various other U.S. federal and state laws, as well as analogous foreign laws and regulations, including the federal anti-kickback statute, the False Claims Act, antitrust laws, and state laws governing kickbacks, false claims, unfair trade practices, and consumer protection. These laws are administered by, among others, the Department of Justice, the Office of Inspector General of the U.S. Department of Health and Human Services (HHS), the Federal Trade Commission, the Office of Personnel Management, and state attorneys general. State, federal, and foreign governments, agencies, and other regulatory bodies are active in their oversight, enforcement activities, and coordination with respect to pharmaceutical companies, which has resulted in intensified scrutiny, litigation costs, corporate criminal sanctions, and substantial civil settlements in the pharmaceutical industry.

The U.S. Foreign Corrupt Practices Act of 1977 (FCPA) prohibits certain individuals and entities, including U.S. publicly traded companies, from promising, offering, or giving anything of value to foreign officials with the corrupt intent of influencing the foreign official for the purpose of helping the company obtain or retain business or gain any improper advantage. The FCPA also imposes specific recordkeeping and internal controls requirements on U.S. publicly traded companies. As noted above, our business is heavily regulated and therefore involves significant interaction with officials outside the U.S. Additionally, in many countries outside the U.S., healthcare providers who prescribe pharmaceuticals are employed by the government and purchasers of pharmaceuticals are government entities; therefore, our interactions with these prescribers and purchasers are subject to regulation under the FCPA.

In addition to the U.S. application and enforcement of the FCPA, the various jurisdictions in which we operate and supply our products have laws and regulations aimed at preventing and penalizing corrupt and anticompetitive behavior. 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.

We are, and could in the future become, subject to administrative and legal proceedings and actions, which could include claims for civil penalties (including treble ~~damages under the False Claims Act)~~damages), criminal sanctions, and administrative remedies, including exclusion from U.S. federal and other healthcare programs. It is possible that an adverse outcome in future actions could have a material adverse impact on our consolidated results of operations, liquidity, and financial position in any given period.

We are also subject to a variety of federal, state, local, and foreign environmental, health and safety, and other laws and regulations that may affect our research, development, or production efforts.

1415

Regulations and Private Payer Actions Affecting Pharmaceutical Pricing, Reimbursement, and Access

U.S.

There continues to be considerable public and government scrutiny of pharmaceutical pricing. In addition, U.S. government actions to reduce federal spending on entitlement programs, including Medicare and Medicaid, may affect payment for our products or services associated with the provision of our products.

In August 2022, the U.S. government enacted the Inflation Reduction Act of 2022 (IRA). Among other measures, the IRA ~~will require the U.S. Department of Health and Human Services~~requires HHS to effectively set prices for certain single-source drugs and biologics reimbursed under Medicare Part B and Part D. Generally, these government prices apply nine ~~(medicines~~years (for medicines approved under an NDA) or thirteen ~~(medicines~~years (for medicines approved under a Biologics License ~~Application) years~~Application (BLA)) following initial FDA approval and will be ~~capped~~set at a ~~statutory ceiling~~ price that is likely to represent a significant discount from existing average prices to wholesalers and direct purchasers. ~~It is too soon to tell how the U.S. government will set these prices as~~While the law specifies a ceiling price, ~~but~~it does not set a minimum or floor price. ~~One or more~~In August 2023, HHS selected Jardiance, which is part of our collaboration with Boehringer Ingelheim, as one of the first ten medicines subject to government-set prices effective in 2026. Given our product portfolio, we expect additional significant products ~~may~~will be selected in future years, which would have the effect of accelerating revenue erosion prior to ~~patent expiry.~~expiry of exclusivities. The effect of reducing prices and reimbursement for certain of our products would significantly impact our business and consolidated results of operations. ~~The establishment of payment limits or other restrictions by drug affordability review boards and other state level actors would similarly impact us.~~

Other IRA provisions ~~provide for rebate obligations on~~require drug manufacturers ~~that increase prices of~~to provide rebates for Medicare Part B and Part D medicines ~~at a rate greater than~~under certain circumstances. Also, the ~~rate of inflation and~~ Part D benefit redesign ~~that includes replacing~~will replace the Part D ~~coverage gap discount program~~Coverage Gap Discount Program (CGDP) with a new manufacturer ~~discounting~~discount program. Beginning in January 2025, the 70 percent CGDP discount will be replaced by a 10 percent manufacturer discount for all Medicare Part D beneficiaries that have met their deductible and incurred out of pocket drug costs below a $2,000 threshold and a 20 percent discount for beneficiaries that have incurred out of pocket drug costs above the $2,000 threshold under the Part D benefit redesign. Manufacturers that fail to comply with the IRA may be subject to various penalties, including civil monetary penalties, which could be significant.

The IRA ~~takes effect progressively starting in 2023, with the first government-set prices effective in 2026. The IRA may~~has and will meaningfully influence our business strategies and those of our competitors. In particular, the nine-year timeline to set prices for medicines approved under an NDA ~~may reduce~~reduces the attractiveness of investment in small molecule innovation. The ~~implications~~IRA can cause changes to ~~us of a competitor’s product being selected for price setting are also uncertain. Provisions of the IRA may be subject to legal challenges or other reformation,~~development approach, and ~~the~~timing and investments at-risk. The full impact of the IRA on our business and the pharmaceutical industry, including the implications to us of a competitor's product being selected for price setting, remains uncertain.

Heightened governmental scrutiny over the manner in which drug manufacturers price their marketed products and the practices of pharmacy benefit managers and other supply chain entities has also resulted in several U.S. Congressional inquiries and proposed and enacted federal and state legislation designed to, among other things, bring more transparency to product pricing, review the relationship between pricing and manufacturer patient programs, require advance notice of list price increases, establish upper payment limits or other restrictions by drug affordability review boards, allow the importation of drugs from other countries, address pharmacy benefit manager practices, and reform government program reimbursement methodologies for drug products. Restrictive or unfavorable pricing, coverage, or reimbursement determinations for our medicines or product candidates by governments, regulatory agencies, courts, or private payers could also adversely impact our business and financial results. For example, in April 2022, the Centers for Medicare & Medicaid Services issued the Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease national coverage determination (the Alzheimer's Monoclonal Antibody NCD) limiting coverage of FDA-approved monoclonal antibodies that target amyloid for the treatment of Alzheimer's disease for people with Medicare only if they are enrolled in qualifying clinical trials. In its current form, the Alzheimer’s Monoclonal Antibody NCD would result in significantly reduced coverage for, and negatively impact, our product candidate donanemab, and may negatively impact our business and financial results. Additional policies, regulations, legislation, or enforcement, including those proposed or pursued by the U.S. Congress, the ~~current~~ U.S. ~~presidential administration,~~executive branch and regulatory authorities worldwide, could intensify these efforts and adversely impact our business and consolidated results of operations.

In the U.S., we are required to provide rebates to the federal government and state governments on their purchases of our pharmaceuticals under various federal and state healthcare programs, including state Medicaid and Medicaid Managed Care programs ~~(minimum~~(a minimum of 23.1 percent plus adjustments for price increases above the consumer price index over time) and discounts to private entities who treat patients in certain types of healthcare facilities intended to serve low-income and uninsured patients (known as 340B covered entities). Additionally, an annual fee is imposed on pharmaceutical manufacturers and importers that sell branded prescription drugs to specified government programs. ~~Since 2019,~~

Changes to the ~~Bipartisan Budget Act has required manufacturers of brand-name drugs, biologics, and biosimilars to provide~~340B program or the Medicaid programs could have a ~~discount of 70 percent~~material adverse impact on our business. For example, continued expansion of the ~~cost~~340B program and growth of ~~branded prescription drugs for Medicare Part D participants who are~~entities claiming entitlement to 340B pricing, including in ways that may be inconsistent with the ~~"doughnut hole" (the coverage gap in Medicare prescription drug coverage). Beginning in October 2024,~~statutory scheme, impacts our revenue on an increasing percentage of sales. Changes to the calculation of rebates under the ~~IRA~~Medicaid program could also increase our Medicaid rebate obligations and decrease the ~~70 percent discount will be replaced~~prices charged to 340B covered entities.

We have implemented a Contract Pharmacy Limited Distribution System applicable to sales through the 340B program, which generally limits distribution of 340B-priced product to: (i) covered entities and their child sites; (ii) contract pharmacies wholly owned by the covered entity; or (iii) if a covered entity lacks an in-house outpatient pharmacy, a single contract pharmacy designated by a ~~10 percent discount~~covered entity to establish a 340B bill to/ship to arrangement. Our Contract Pharmacy Limited Distribution System contains certain exceptions that permit broader contract pharmacy usage, including for "penny priced" insulin products, provided that the covered entity passes through all ~~Medicare Part D beneficiaries~~discounts to eligible patients at the point of sale and meets other conditions. We believe our Contract Pharmacy Limited Distribution System complies with the 340B statute, but it remains subject to ongoing inquiries and litigation that could have ~~met their deductible~~a material impact on our business, as discussed in Item 8, "Financial Statements and ~~incurred out~~Supplementary Data—Note 16: Contingencies." Other aspects of ~~pocket drug costs below a $2,000 threshold~~the 340B program, including the proper definitions of "patient" and ~~a 20 percent discount for beneficiaries that have incurred out~~"child site" under the 340B statute, are also subject to ongoing litigation by other parties, the resolution of ~~pocket drug costs above~~which could impact the ~~$2,000 threshold.~~growth and scope of the 340B program.

Rebates are also negotiated in the private sector. We pay rebates to private payers that provide prescription drug benefits to seniors covered by Medicare and to private payers that provide prescription drug benefits to their customers. These rebates are affected by the introduction of competitive products and generics in the same class. 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 ~~currently~~ been stayed until at least January 1, 2032.

For a discussion of risks related to how we price our products, see Item 1A, "Risk Factors—Risks Related to Our Business—We face litigation and investigations related to our products, how we price or commercialize our products, and ~~how we commercialize~~other aspects of our ~~products; we could face large numbers of claims in the future,~~business, which could adversely affect our business, and we are self-insured for such matters."

Outside the U.S.

Globally, public and private payers are increasingly restricting access to pharmaceuticals based on assessments of comparative effectiveness and value, including through the establishment of formal health technology assessment processes. In addition, third-party organizations, including professional associations, academic institutions, and non-profit entities associated with payers, conduct and publish comparative effectiveness and cost/benefit analyses on medicines, the impact of which ~~are uncertain.~~can influence pharmaceutical access and pricing.

In most international markets, we operate in an environment of government-mandated cost-containment programs, which may include price controls, international reference pricing (to other countries' prices), discounts and rebates, therapeutic reference pricing (to other, often generic, pharmaceutical choices), regulatory hurdles, restrictions on physician prescription levels, and mandatory generic substitution. In ~~October 2022,~~these markets, healthcare services and the ~~German Parliament passed~~determination of pricing and reimbursement for pharmaceutical products are impacted by government control at the point of care or as the primary payer.

The European Commission published its draft General Pharmaceutical Legislation in April 2023. While certain elements in the European Commission draft could expedite regulatory timelines, we anticipate that the overall market and patient impact would be negative if the legislation is approved as drafted. Implementation timing is unknown at this time. Health care cost ~~cutting reforms and these reforms were followed~~containment remains a focus in the EU, among other jurisdictions. Most countries in the EU attempt to contain drug costs by ~~activation~~engaging in some form of reference pricing in which authorities examine pre-determined internal or external markets for published prices of a ~~clawback mechanism~~product or national class of drugs. Member states also have the power to restrict the range of pharmaceutical products for which their national health insurance systems provide reimbursement and may condition access on agreement of a reimbursement price or completion of cost-effectiveness or other gating studies.

In Japan, our products generally are subject to government-mandated annual price reductions. The government may also order re-pricings for specific products or classes of products if certain criteria are met, including exceeding product use thresholds.

China has introduced and implemented reforms to accelerate access to innovative products and reduce costs. To drive patient access, we seek inclusion of many of our branded products on China's National Reimbursement Drug List, a list of drugs fully or partially reimbursed by China’s national basic health insurance. In exchange for broad access, these products are generally subject to negotiation of significant price concessions. China also utilizes a value-based procurement program process for products that have generic substitutes. Products that we choose to tender through this process are similarly subject to price reductions. Our performance in ~~France and implementation of increased mandatory rebates in the United Kingdom. These changes~~China may be ~~followed~~significantly impacted by the country's evolving pharmaceutical regulatory environment, including access, intellectual property protection, regulatory enforcement and compliance, and trade policies.

Governments in ~~2023 by biopharmaceutical-focused austerity~~many emerging markets are also focused on limiting health care costs and have enacted price controls and measures impacting intellectual property. Reforms in ~~more countries in Europe and in other markets. Reforms,~~our product markets, including those that may stem from periods of uneven economic ~~downturn~~growth or downturns or uncertainty, or as a result of high inflation, emergence, or escalation of, and responses to, ~~war or unrest (including the Russia-Ukraine war),~~international tension and conflicts, or government budgeting priorities, ~~(including as exacerbated by the COVID-19 pandemic),~~ may continue to result in added pressure on pricing and reimbursement for our products.

We cannot predict the extent to which our business may be affected by ~~these~~current or ~~other~~ potential future legislative, regulatory, or payer developments. However, in general we expect to see continued focus on regulating pricing, resulting in additional state, federal, and international legislative and regulatory developments that could have further negative effects on pricing and reimbursement for our ~~products.~~products as well as overall operations.

See Item 7, "Management's Discussion and Analysis—Executive Overview—Other Matters—Trends Affecting Pharmaceutical Pricing, Reimbursement, and Access" for additional information regarding recent legislative, administrative, and other pricing initiatives and their impact on our results.

Research and Development

Our commitment to research and development dates back more than 140 years. We invest heavily in research and development because we believe it is critical to our long-term competitiveness. At the end of ~~2022,~~2023, we employed approximately ~~9,000~~10,000 people in pharmaceutical research and development activities, including a substantial number of physicians, scientists holding graduate or postgraduate degrees, and highly skilled technical personnel.

Our internal pharmaceutical research focuses primarily on the areas of metabolism (including diabetes, obesity ~~& diabetes,~~and cardiovascular), immunology, neuroscience, and oncology. ~~At the outset of the COVID-19 pandemic, we also focused on researching and developing potential treatments for COVID-19.~~ In addition to discovering and developing new medicines, we seek to expand the value of existing products through new uses, formulations, and therapeutic approaches, including complementary delivery devices or diagnostic tools, that can provide additional value to patients.

To supplement our internal efforts, we collaborate with others, including academic institutions and research-based pharmaceutical and biotechnology companies. We use the services of physicians, hospitals, medical schools, and other research organizations worldwide to conduct clinical trials to establish the safety and effectiveness of our medicines. We also invest in external research and technologies that we believe complement and strengthen our own efforts. These investments can take many forms, including, among others, licensing arrangements, co-development agreements, co-promotion arrangements, joint ventures, acquisitions, and equity investments.

Pharmaceutical development is time-consuming, expensive, and risky. Very few of the candidates discovered by researchers ultimately become approved medicines. The process from discovery to regulatory approval can take over a decade. Candidates can fail at any stage of the process, and even late-stage candidates sometimes fail to receive regulatory approval or achieve commercial success. In addition, novel modalities can present more challenging or lengthy development timelines. The following describes in more detail the research and development process for pharmaceutical products:

Phases of New Drug Development

•Discovery Phase

In the discovery phase, scientists identify, design, and synthesize promising candidates by analyzing their effect on biological targets thought to play a role in disease. Targets are often unproven and only candidates that have the desired effect on the target and meet other design criteria move to the next phase of development, which includes the initiation of studies in animals to support regulatory and safety requirements for clinical research in humans. The discovery phase can take years and the probability of any one candidate becoming a medicine is extremely low.

•Early Development Phase

Early development includes initial testing for safety and efficacy and early analyses of manufacturing requirements. Safety testing is initially performed in laboratory tests and animals, as necessary. In general, the first human tests (often referred to as Phase I) are conducted in small groups of subjects to assess safety and evaluate the potential dosing range. Subsequently, larger populations of patients are studied (Phase II) to identify ~~initial~~ signs of efficacy while continuing to assess safety. In parallel, scientists work to identify safe, effective, and economical manufacturing processes. Long-term animal studies continue to test for potential safety issues. Of the candidates that enter the early development phase, approximately 10 percent move to the late development phase. The early development phase varies but can take several years to complete.

•Late Development Phase

Late phase development projects (typically Phase III) have met initial safety requirements and shown initial evidence of efficacy in earlier studies. As a result, these candidates generally have a higher likelihood of success and trials include larger patient populations to demonstrate safety and efficacy in the disease. These studies are designed to demonstrate the benefit and risk of the potential new medicine and may be compared to competitive therapies, placebo, or both. Phase III studies are generally conducted globally, are costly, and are designed to support regulatory filings for marketing approval. The duration of Phase III testing varies by disease and may take ~~two to four~~ years.

•Submission Phase

Once a potential new medicine is submitted to regulatory agencies, the time to final marketing approval can vary from several months to several years, depending on the disease state, the strength and complexity of available data, the degree of unmet need, and the time required for the regulatory agency(ies) to evaluate the submission, which can depend on prioritization by regulators and other factors. There is no guarantee that a potential medicine will receive marketing approval, or that decisions on marketing approvals or indications will be consistent across geographic areas.

We believe our investments in research, both internally and in collaboration with others, have resulted in a robust pipeline of potential new medicines and new treatment indications in all stages of development. We have a number of ~~new medicine~~ ~~candidates in clinical development or under regulatory review, and we have a larger number of projects in the discovery phase.~~ See Item 7, "Management's Discussion and Analysis—Executive Overview—Late-Stage Pipeline," for more information on our late-stage product candidates.

Raw Materials and Product Supply

Most of the principal materials we use in our manufacturing operations are available from more than one source. However, ~~we obtain~~ certain raw or intermediate materials ~~primarily~~are procured from ~~only one~~a single source. We ~~generally~~ seek to maintain sufficient inventory to provide reliability of production and manage unforeseen supply ~~the market until an alternative source of supply can be implemented, in the event one of these suppliers becomes unable to provide the materials or product.~~variability. However, various developments have led, and may in the future lead, to interruption or shortages in supply until we establish new sources, implement alternative processes, bring new manufacturing facilities online, or pause or discontinue product sales in one or more markets.

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. Finishing operations, including formulation, filling, assembling, delivery device manufacturing, and packaging, take place at a number of sites throughout the world. To support anticipated demand for our current and prospective products, we have undertaken significant manufacturing expansion initiatives. During 2023, commercial production commenced at our Research Triangle Park manufacturing site in Durham, North Carolina. Further investments to increase our manufacturing capacity include planned sites in Concord, North Carolina, Limerick, Ireland, Alzey, Rhineland-Palatinate, Germany, and two in Lebanon, Indiana. We also utilize and are expanding arrangements with third parties for certain active ingredient manufacturing, filling, finishing operations, and ~~finishing operations.~~for device or component production and assembly.

We manage our supply chain (including our own facilities, contracted arrangements, and inventory) in a way that is intended to allow us to meet ~~substantially all expected~~ product demand while maintaining flexibility to reallocate manufacturing capacity to improve efficiency and respond to changes in supply and demand. To maintain supply of our products, we use a variety of techniques, including comprehensive quality systems, inventory management, and back-up sites.

However, pharmaceutical production processes are complex, highly regulated, and vary widely from product to product. Shifting or adding manufacturing capacity ~~can be~~is a very lengthy process requiring significant capital expenditures, process modifications, and regulatory approvals. Accordingly, developments such as unanticipated demand, unplanned plant shutdowns, manufacturing or quality assurance difficulties at one of our facilities or contracted facilities, failure or refusal of a supplier or contract manufacturer to supply contracted quantities, increases in demand on a supplier, or difficulties in predicting or variability in demand for our products and those of our competitors have led, and may in the future lead, to interruption or higher costs in the supply of certain products, product shortages, or pauses or discontinuations of product sales in one or more markets. 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. Further, cost and wage inflation, availability of adequate capacity in global transportation, supply chain complexities, including consolidation therein, labor market issues, international tension and ~~logistics challenges, cost inflation,~~conflicts, uneven economic growth or downturns, an increase in overall demand in our industry for certain products and ~~tight labor markets,~~materials, and public health outbreaks, epidemics, or pandemics, such as the COVID-19 pandemic, have caused, and in the future may cause, delays or disruptions in and/or increased costs related to distribution of our medicines, the construction or acquisition of manufacturing capacity, procurement activity, and supplier or contract manufacturer ~~arrangements.~~arrangements, as well as other general business impacts. For more information on the additional risks we face in connection with any difficulties, disruptions, and shortages in the manufacturing, distribution, and sale of our products, see Item 1A, "Risk Factors—Risks Related to Our Business—Manufacturing, quality, or supply chain difficulties, disruptions, or shortages could lead to product supply problems."

In addition, cost inflation, the strain on global transportation, logistics, and labor markets (including as exacerbated by the COVID-19 pandemic and the emergence or escalation of, and responses to, war or unrest, including the Russia-Ukraine war), global economic downturns or uncertainty, and an increase in overall demand in our industry for certain products and materials have had, and may continue to have, a number of impacts on our business, including increased costs and disruptions in the supply of our medicines. For more information, see Item 1A, "Risk Factors—Risks Related to Our Business—Public health outbreaks, epidemics, or pandemics, such as the COVID-19 pandemic, have adversely impacted and may in the future adversely impact our business and operations." and Item 7, "Management's Discussion and Analysis—Executive Overview—Other Matters—COVID-19 Pandemic."

Quality Assurance

Our success depends in great measure on customer confidence in the quality of our products and in the integrity of the data that support their safety and effectiveness. Product quality requires a total commitment to quality in all parts of our operations, including research and development, purchasing, facilities planning, manufacturing, distribution, and dissemination of information about our medicines.

Quality of production processes involves strict control of ingredients, equipment, facilities, manufacturing methods, packaging materials, and labeling. We perform tests at various stages of production processes and on the final product in an effort to ensure that the product meets all applicable regulatory requirements and our internal standards. These tests may involve chemical and physical chemical analyses, microbiological testing, testing in animals, or a combination thereof. Additional assurance of quality is provided by quality assurance groups that audit and monitor all aspects of quality related to pharmaceutical manufacturing procedures and systems in company operations and at third-party suppliers.

Executive Officers of the Company

The following table sets forth certain information regarding our current executive officers.

The term of office for each executive officer expires on the date of the annual meeting of the board of directors, to be held on May ~~1, 2023~~6, 2024 in connection with the company's annual meeting of shareholders, or on the date his or her successor is chosen and qualified. No director or executive officer has a "family relationship" with any other director or executive officer of the company, as that term is defined for purposes of this disclosure requirement. There is no understanding between any executive officer or director and any other person pursuant to which the executive officer was selected.

1920


Name	Age	Titles and Business Experience
David Ricks	5556	Chair, President, and Chief Executive Officer (CEO) (since 2017). Previously, Mr. Ricks held various leadership roles with Lilly, including senior vice president and president, Lilly Bio-Medicines. Mr. Ricks has 2627 years of service with Lilly.
Anat Ashkenazi	5051	Executive Vice President and Chief Financial Officer (since 2021). Previously, Ms. Ashkenazi held various leadership roles with Lilly, including senior vice president, controller and chief financial officer, Lilly Research Laboratories, and vice president, finance and chief financial officer, Lilly Diabetes and Lilly global manufacturing and quality. Ms. Ashkenazi has 2122 years of service with Lilly.
Eric Dozier	5657	Executive Vice President, Human Resources and Diversity (since 2022). Previously, Mr. Dozier held various leadership roles with Lilly, including senior vice president, chief commercial officer for Loxo@Lilly, and vice president, global ethics and compliance officer. Mr. Dozier has 2526 years of service with Lilly.
Anat Hakim	5354	Executive Vice President, General Counsel and Secretary (since 2020). Prior to joining Lilly, Ms. Hakim was senior vice president, general counsel and secretary of WellCare Health Plans, Inc. (WellCare) from 2016 to 2018, and executive vice president, general counsel and secretary of WellCare from 2018 to 2020. Prior to joining WellCare, she served as divisional vice president and associate general counsel of intellectual property litigation at Abbott Laboratories from 2010 to 2013 and divisional vice president and associate general counsel of litigation from 2013 to 2016. Ms. Hakim has ~~three~~four years of service with Lilly.
Edgardo Hernandez	4849	Executive Vice President and President, Manufacturing Operations (since 2021). Previously, Mr. Hernandez held various leadership roles with Lilly, including senior vice president, global parenteral drug product, delivery devices and regional manufacturing, and vice president, Fegersheim operations. Mr. Hernandez has 1819 years of service with Lilly.
Patrik Jonsson	5657	Executive Vice President and President, Lilly ~~Immunology,~~Diabetes and Obesity and President, Lilly USA ~~and Chief Customer Officer~~ (since ~~2021)~~2024). ~~Previously,~~ Mr. Jonsson has held various leadership roles with Lilly, including, ~~senior vice president~~most recently, as Executive Vice President and ~~president,~~President, Lilly Immunology and Lilly USA, and ~~chief customer officer,~~Chief Customer Officer. Previously, he served as senior vice president and president, Lilly Bio-Medicines and president and general manager, Lilly Japan. Mr. Jonsson has ~~32 years of service with Lilly.~~
~~Michael Mason~~	56	Executive Vice President and President, Lilly Diabetes (since 2020). Previously, Mr. Mason held various leadership roles with Lilly, including senior vice president, connected care and insulins and vice president of U.S. Diabetes. Mr. Mason has 33 years of service with Lilly.
Johna Norton	5657	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 ~~32 years of service with Lilly.~~
~~Leigh Ann Pusey~~	60	Executive Vice President, Corporate Affairs and Communications (since 2017). Prior to joining Lilly, Ms. Pusey was president and chief executive officer of the American Insurance Association from 2009 to 2017. Ms. Pusey has five33 years of service with Lilly.
Diogo Rau	4849	Executive Vice President and Chief Information and Digital Officer (since 2021). Prior to joining Lilly, Mr. Rau was senior director of information systems and technology for retail and online stores of Apple Inc. from 2011 to 2021. Prior to his tenure at Apple, he served as a partner at McKinsey & Company. Mr. Rau has ~~two~~three years of service with Lilly.
Daniel Skovronsky, M.D., Ph.D.	4950	Executive Vice President, Chief Scientific Officer and President, Lilly Research Laboratories and Lilly Immunology (since 2024). Prior to assuming his current role, Dr. Skovronsky served as Executive Vice President, Chief Scientific and Medical Officer, and President, Lilly Research Laboratories ~~(since 2021). Previously,~~since 2018. Dr. Skovronsky has held ~~various~~other leadership roles with Lilly, including ~~senior vice president, chief scientific officer, and president, Lilly Research Laboratories, and~~as senior vice president, clinical and product ~~development.~~development and vice president, diabetes research. Dr. Skovronsky has 1213 years of service with Lilly.
Jacob Van Naarden	3839	Executive Vice President ~~CEO, Loxo@Lilly,~~ and President, ~~Lilly Oncology~~Loxo@Lilly (since 2021). Previously, Mr. Van Naarden served as ~~Chief Executive Officer-Loxo~~chief executive officer-Loxo Oncology at Lilly, and ~~Chief Operating Officer-Loxo~~chief operating officer-Loxo Oncology at Lilly. Mr. Van Naarden joined Lilly in 2019 when the company acquired Loxo Oncology, Inc., where he was the chief operating officer. In previous roles, Mr. Van Naarden worked in various biotechnology investing, operating, and advisory capacities, including positions with HealthCor Management, Aisling Capital, and Goldman Sachs. Mr. Van Naarden has ~~four~~five years of service with Lilly.
Alonzo Weems	5253	Executive Vice President, Enterprise Risk Management, and Chief Ethics and Compliance Officer (since 2021). Previously, Mr. Weems held various leadership roles with Lilly, including vice president and deputy general counsel for corporate legal functions, general counsel for Lilly USA, and general counsel for biomedicines and diabetes. Mr. Weems has 2526 years of service with Lilly.
Anne White	5455	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 2728 years of service with Lilly.
Ilya Yuffa	4849	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 2627 years of service with Lilly.

2021

Human Capital Management

Our core values—integrity, excellence, and respect for people—shape our approach to attracting, retaining, engaging, and developing a diverse and highly skilled and ethical workforce, which is critical to executing our strategy. 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. For instance, most of the products we sell today were discovered or developed by our own scientists, and our long-term success depends on our ability to continually discover or acquire, develop, and commercialize innovative medicines. We believe that fostering a positive culture that values the contributions of our talented colleagues helps drive our success.

We are committed to creating a safe, supportive, ethical, and rewarding work environment through strategic focus on our human capital management process, fairness and nondiscrimination in our employment practices, robust training and development opportunities, and competitive pay and benefits. We believe our dedication to promoting diversity, equity, and inclusion ~~(DEI)~~ within our company reflects our values and is a key driver of business success and growth.

We regularly conduct ~~anonymous~~confidential employee surveys to seek feedback from our workforce on a variety of topics. These results are reviewed and analyzed by our leaders to identify opportunities to adjust our policies and benefits to improve our employees' experience. As a result of our efforts, we believe that we have a highly performing, cohesive workforce and that our employee relations are good.

At the end of ~~2022,~~2023, we employed approximately ~~39,000~~43,000 people, including approximately ~~21,000~~23,000 employees outside the U.S. Our employees include approximately ~~9,000~~10,000 people engaged in research and development activities.

Strategy and Oversight

~~In order~~We are committed to ~~build~~fairness and nondiscrimination in our employment practices, and we deeply value diverse backgrounds, skills, and ~~inclusive teams, our CEO and executive committee set expectations for inclusive leadership and hold leaders accountable for achieving results.~~global perspectives. Because dedication to human capital management is also a core component of our corporate governance, our board of directors regularly engages with management and facilitates a system of reporting designed to monitor human capital management initiatives and progress as part of the overarching framework that guides how we attract, retain, engage, and develop a workforce that aligns with our values and mission.

~~Diversity, Equity, and Inclusion~~

We are committed to fairness and nondiscrimination in our employment practices, and we deeply value diverse backgrounds, skills, and global perspectives. To fulfill our purpose, we believe we must look at challenges from multiple viewpoints and understand the diverse experiences of the patients who depend on us.

~~We believe that fostering DEI begins with understanding. For example, our~~ ~~Employee Journeys~~ research has yielded important insights about the experiences of women, Black/African American, Latinx, Asian, and LGBTQ+ employees at Lilly. The results of this research are reviewed by our senior leadership, and we deploy actions and activities in response to these insights to improve our workplace and corporate culture.

In 2020, as part of our DEI and community initiatives, Lilly and the Lilly Foundation launched the Racial Justice Commitment, with Lilly pledging 25,000 volunteer hours and the Lilly Foundation committing $25 million over five years to help decrease the burden of racial injustice and its effects on communities of color. The Racial Justice Commitment aims to drive change across five areas: internal people development, health equity, social impact, diversity partners, and family sustaining jobs, through the use of financial and people resources. From 2020 through 2022, we have made progress in these efforts, including nearly tripling our spending with Black-owned businesses, committing over $98 million in minority-led venture capital firms, serving over 30,000 volunteer hours to advance racial justice initiatives, and expanding our Skills First Program at Lilly for individuals without four-year college degrees.

Since 2017, we have committed to increasing women, Black/African American, Latinx, and Asian representation in leadership roles, and we actively monitor our progress. From the end of 2018 through the end of 2022, we increased the percentage of women in management globally from 42 percent to 49 percent. For minority group members (MGM) in the U.S. over the same period, we increased management representation from 19 percent to 25 percent. Across all levels of our workforce, from the end of ~~2018~~2019 through the end of ~~2022,~~2023, we have seen ~~increased~~positive changes in representation for ~~MGMs~~minority group members (MGM) in the ~~U.S.~~United States and women globally. ~~Our focus on DEI is also evident at our executive committee and board~~In addition, 4 of ~~directors. Five of 15~~13 current members (approximately 3331 percent) of our executive committee (which includes our CEO) are women and ~~three~~3 are MGMs. In addition, as of the filing of this ~~report,~~Annual Report on Form 10-K, the company's ~~13-member~~12-member board of directors includes five women and ~~six~~five members who are MGMs.

Our efforts in DEI and workplace benefits have garnered numerous recognitions, including, in 2022, Top 50 Companies for Diversity by DiversityInc., Top Companies for Board of Directors by DiversityInc., Top Companies for Supplier Diversity by DiversityInc., Top Companies for ESG by DiversityInc., America's Best Employers for Women by Forbes, Perfect Scorerecruitment strategy focuses on ~~the Human Rights Campaign Foundation Corporate Equality Index, World's Most Ethical Companies by Ethisphere, Perfect Score on Disability Equity Index Best Places~~opportunities to Work by Disability:IN, Pharmaceutical Innovation Index, Zero Project Award for Access Lilly, and Top Companies for Executive Women, Best Companies for Multicultural Women, Best Companies for Dads, 70 percent and Higher Inclusion Index by Seramount.

~~Employee Development~~

~~We believe attracting and retaining the best, diverse talent begins with the hiring process. We therefore require hiring managers to consider a diverse~~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 weexperience. We also strive to provide a diverse panel of interviewers for open positions. We believe that ~~hiring~~recruiting in this way helps ensure that ~~people from all backgrounds~~everyone will have an equal opportunity to advance their careers.

~~In early 2022, we launched~~ ~~Discover~~, a 12-month new employee onboarding program with multiple touchpoints designed to foster integration into Lilly, to accelerate learning in their new roles and to create connections to further a sense of belonging at Lilly. ~~Discover~~ ~~was shaped in part by external benchmarking, feedback from employees, and learnings from onboarding remotely during the COVID-19 pandemic.~~

We offer training to enable our employees to perform their duties in our highly regulated industry. We also strive to cultivate a culture that promotes ongoing learning by encouraging employees to seek further education and growth experiences, helping them build rewarding careers. We have introduced online programming to facilitate access to our learning and development offerings in addition to our in-person programs. Many training courses are designed to improve accessibility for people with disabilities and other unique needs. Across Lilly, we are continuously working to design learning experiences to be more inclusive and effective. In addition, we have implemented development tools and resources for all employees, improved our talent programs and processes to provide broader access to information, and increased transparency regarding career development and advancement at Lilly.

Employee resource groups (ERGs) are another important component of developing talent at Lilly. We currently have 11 ERGs representing groups including women, MGMs, LGBTQ+ individuals, veterans, and people with disabilities. ERGs offer our diverse workforce opportunities to build relationships, engage with senior leaders, advance our caring community, and offer unique insights and perspectives to improve our business.

We have continued our efforts to create an inclusive workplace with the goal of ensuring that all employees feel safe to speak up and share their ideas at work. Our Make it Safe to Thrive education and awareness program is designed to help employees and leaders understand how individual psychological safety can be created and enhanced and includes live and online training. In late 2022, we introduced a new version of Make it Safe to Thrive for leaders that continues to focus on psychological safety and creating an inclusive environment. Leaders are provided the opportunity to work through challenging conversations and situations currently being navigated in the workplace.

Lilly is committed to fostering a culture of diversity and respect in the workplace—an environment free of discrimination, harassment, or retaliation of any kind. In 2022, as part of our annual review of The Red Book and related policies and procedures, we revised the Global Conduct in the Workplace procedure to continue to help ensure that we maintain a respectful, safe, inclusive, and professional workplace.

Employee Health and Safety

We strive to foster a healthy, vibrant work environment, which includes keeping our employees safe. We seek to create a companywide culture where best-in-class safety practices are consistently followed. To do this, we assess and continuously attempt to improve our companywide safety performance to promote the well-being of employees and to help safeguard communities where we operate. ~~As the COVID-19 pandemic has evolved, we have continued to take various measures (as necessary) to protect and support the health and safety of our employees globally.~~ We believe a holistic approach and dedication to safety helps us be our best as we deliver on our company purpose to improve lives around the world.

Information Available on Our Website

Our company website is www.lilly.com. None of the information accessible on or through our website is incorporated into this Annual Report on Form 10-K. We make available through the website, free of charge, our company filings with the ~~SEC~~Securities and Exchange Commission (SEC) as soon as reasonably practicable after we electronically file them with, or furnish them to, the SEC. These include our Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, proxy statements, registration statements, and any amendments to those documents. The link to our SEC filings is investor.lilly.com/financial-information/sec-filings.

Paper copies of the company's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q that are filed with the SEC are available without charge upon written request to:

ELI LILLY AND COMPANY

c/o General Counsel and Secretary

Lilly Corporate Center

Indianapolis, Indiana 46285

In addition, the "Governance" section of our website includes our corporate governance guidelines, board of directors and committee information (including committee charters), and our articles of incorporation and bylaws. The link to our corporate governance information is lilly.com/leadership/governance.

We routinely post important information for investors in the “Investors” section of our website, www.lilly.com. We may use our website as a means of disclosing material, non-public information and for complying with our disclosure obligations under Regulation FD. Accordingly, investors should monitor the “Investors” section of our website, in addition to following our press releases, filings with the SEC, public conference calls, presentations, and webcasts. We may also use social media channels to communicate with investors and the public about our business, products and other matters, and those communications could be deemed to be material information. The information contained on, or that may be accessed through, our website or social media channels, is not incorporated by reference into, and is not a part of, this Annual Report on Form 10-K.

Item 1A.Risk Factors

In addition to the other information contained in this Annual Report on Form 10-K, the following risk factors should be considered carefully in evaluating our company. It is possible that our business, financial condition, liquidity, cash flows, or results of operations, reputation, and prospects could be materially adversely affected by any of these risks. ~~Certain of these risks could also adversely affect the company's reputation.~~ Additional risks and uncertainties not presently known to us or that we currently believe to be immaterial could also adversely affect our business, financial condition, liquidity, cash flows, results of operations, reputation, and ~~reputation.~~prospects.

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.

There are many difficulties and uncertainties inherent in pharmaceutical research and development, the introduction of new products and indications, business development activities to enhance or refine our product ~~pipeline.~~pipeline, and commercialization of our products.

There is a high rate of failure inherent in ~~new~~ drug discovery and development. To bring a ~~drug~~product from the discovery phase to market ~~can take over a decade~~takes considerable time and ~~often costs in excess of $2 billion.~~entails significant cost. 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 ~~new~~newer, better, or ~~better~~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. ~~Delays, uncertainties, unpredictabilities,~~Delay, uncertainty, unpredictability, and ~~inconsistencies~~inconsistency in drug approval processes across markets and agencies can result in delays in product launches, lost market ~~opportunity, potential~~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.~~indications, which in some cases leads to difficulty meeting product demand or, on the other hand, 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, indications or products; or whether our products and indications, once launched, will be commercially successful.

WeThrough internal innovation and business development we must maintain a continuous flow of successful new products and ~~successful new~~ indications or line extensions ~~for existing products, both through our internal efforts and our business development activities,~~ 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. Failure to ~~do so in the short-term or long-term~~timely replenish our product portfolio and pipeline would have a material adverse effect on our business, results of operations, cash flows, and financial position. Our dependence on, or focus in, one or more key products or product classes may exacerbate this risk. In addition, the growth of our business and revenue base increases the risk that products developed or acquired by us may not provide adequate value to sustain further long-term growth.

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 and promotion agreements, joint ventures, acquisitions, equity investments, and ~~equity investments.~~divestitures. There are

substantial risks associated with identifying successful business development targets and consummating related transactions. Increased 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. In addition, failures or difficulties in integrating or retaining new personnel or the operations of the businesses, products, or assets we acquire (including related technology, commercial operations, compliance programs, information security, manufacturing, distribution, and general business operations and procedures) may affect our ability to realize the expected benefits of business development transactions and may result in our incurrence of substantial asset impairment or restructuring charges. We also may fail to generate the expected revenue and pipeline enhancement from business development activities due to ~~developments outside our control, including~~limited diligence opportunities, unsuccessful clinical trials, issues related to the quality, integrity, or broad applicability of data, regulatory impediments, and manufacturing or commercialization challenges. Additionally, business development activity focused on new modalities may entail additional risks and costs. Accordingly, 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, ~~and~~ may give rise to legal proceedings or regulatory ~~scrutiny.~~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 Development" and Item 7, "Management's Discussion and Analysis—Executive Overview—Late-Stage Pipeline," for more details about our current product pipeline.

•We and our products face intense competition 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.

We compete with a large number of multinational pharmaceutical companies, biotechnology companies, and generic pharmaceutical companies and, in many cases, our products compete against the leading products of one or more of our competitors. To compete successfully, we must continue to deliver to the market innovative, cost-effective products through internal innovation or business development that meet important medical needs, provide improved outcomes for patients, and deliver value to payers. Our product revenues and prospects are adversely affected by 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 drugs.

Regulation of generic and biosimilar products varies around the world and such regulation is complex and subject to ongoing interpretation and implementation by regulatory agencies and courts. Particularly for biosimilars, health authority guidelines and legislative actions could make it less burdensome for competitor products to enter the market and further incentivize uptake of biosimilars. Given the importance to us of marketed biologic products and those in our clinical-stage pipeline, such regulation could have a material adverse effect on our business. See Item 1, "Business—Competition" and "Business—Research and Development," for more details. Alternatively, actual or perceived failure of robust generic and biosimilar competition could propel governments to adopt additional policies and legislation that threaten our intellectual property, pricing of our products, or other aspects of our business.

In addition, we rely on our ability to attract, engage, and retain highly qualified and skilled scientific, technical, management, and other personnel in order to compete effectively. 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, 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. Our ability to attract and retain talent in our increasingly competitive environment is further complicated by evolving employment trends. Our failure to compete effectively for talent could negatively affect sales of our current and any future approved products and indications, and could result in material financial, legal, commercial, or reputational harm to our business.

•Our business is subject to increasing government price controls and other public and private restrictions on pricing, reimbursement, and access for our drugs, which could have a material adverse effect on our results of operations, reputation or business.

Public and private payers continue to take aggressive steps to control their expenditures for pharmaceuticals by placing restrictions on pricing and reimbursement for, and patient access to, our medicines. These pressures have negatively affected, and could continue to negatively affect, our consolidated results of operations. Governments and private payers worldwide have intensified their scrutiny of, and actions intended to address, pricing, reimbursement, and access to pharmaceutical products and are demanding greater commercial and clinical value from pharmaceutical companies in the form of strong product differentiation and demonstrated value. We have experienced increased scrutiny on the pricing of current and potential diabetes, obesity, and Alzheimer's products due to payer concern over projected growth in these markets and, for certain of these drugs, the anticipated duration of treatment. We have also observed scrutiny of pricing and access disparities across jurisdictions.

Additional policies, regulations, legislation, or enforcement, including because of the regulatory priorities of the U.S. presidential administration 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 effective in 2026. Given our product portfolio, we expect additional significant products will be selected in future years, which would have the effect of accelerating revenue erosion prior to exclusivity expiry. The effect of reducing prices and reimbursement for certain of our products would significantly impact our business and consolidated results of operations. Within the U.S., state level transparency initiatives, importation rules, reporting requirements, and mandated programs, including the establishment of drug affordability boards with the power to set upper payment limits on certain drugs in state-regulated plans, have also increased administrative costs, in some cases, compromised confidential business practices and otherwise detrimentally impacted our business. Certain states have also undertaken efforts to codify 340B contract pharmacies into statute which would increase the cost of 340B programs. For more details, see Item 1, "Business—Regulations and Private Payer Actions Affecting Pharmaceutical Pricing, Reimbursement, and Access."

Further, restrictive or unfavorable pricing, coverage, or reimbursement determinations for our medicines or product candidates by governments, regulatory agencies, courts, or private payers, including in relation to the implementation of the IRA, reference pricing, and compulsory licensing, may adversely impact our business and financial results. We continue to experience additional pricing pressures, rebates, clawbacks, and other changes in reimbursement policies and programs resulting from 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.

In addition, government price reporting and payment regulations are complex, and require ongoing assessment of the methods by which we calculate and report pricing. Calculation methodologies are inherently subjective and are subject to review and challenge by government agencies. If agencies disagree with our calculations, or the methodologies and assumptions underlying them, we may need to restate previously reported data and could be subject to financial and legal liability, which may be significant. In addition, changes to calculation methodologies could adversely affect our financial position or consolidated results of operations in any given period.

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

•Pharmaceutical products can develop safety or efficacy concerns, which could have a material adverse effect on our revenues, income, and reputation.

Pharmaceutical products receive regulatory approval based on data obtained in controlled clinical trials of fixed duration and defined populations. After approval and launch, the products are used for longer periods of time by much larger numbers of patients, which may lead to identifying new safety or efficacy concerns. We and others (including regulatory agencies and private payers) collect extensive information on the efficacy and safety of our marketed products by continuously monitoring the use of our products in the marketplace. In addition, we or others (including our competitors, in some cases) may conduct post-marketing clinical studies on efficacy and safety of our marketed products. New safety or efficacy data

from both market surveillance and post-marketing clinical studies of our products or those of our competitors 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 class or 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. Serious safety or efficacy issues that arise after product approval have, and could in the future, result in voluntary or mandatory product recalls or withdrawals from the market. Safety issues have, and could in the future, result in costly product liability claims. Any of these outcomes could result in material financial, legal, commercial, or reputational harm to our business.

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

We derived direct product and/or alliance revenues of more than $2 billion for each of Trulicity, Mounjaro, Verzenio, Taltz and Jardiance (including Glyxambi, Synjardy, and Trijardy XR) that collectively accounted for 63 percent of our total revenues in 2023. In particular, Trulicity and Mounjaro accounted for 36 percent of our total revenues in 2023 and we expect products 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 in demand, regulatory proceedings and investigations, negative publicity affecting doctor or patient confidence, pressure from existing or new competitive products, counterfeit and illegally compounded drugs, changes in labeling, pricing, and insufficient access, or supply shortages or disruptions for these products or any of our other major products could materially impact our results of operations.

In addition, in the U.S., most of our products are distributed through wholesalers and if one of these significant wholesalers should encounter financial or other difficulties, it might decrease the amount of business the wholesaler does with us or we might be unable to timely collect the amounts that the wholesaler owes us, which could negatively impact our results of operations. See Item 1, "Business—Marketing and Distribution," for more details. Challenges to U.S. retail pharmacies due to pharmacy benefit manager reimbursement pressures, among other things, have resulted in financial difficulties for some pharmacies that may impact patient experiences, lead to determinations by certain pharmacies to not carry one or more of our significant products or threaten the viability of these pharmacies, which could negatively impact our business and results of operations.

Moreover, the negotiating power of health plans, managed care organizations, pharmacy benefit managers, and other supply chain entities has increased due to consolidation, regulatory, and other market impacts, and they, along with governments, increasingly employ formularies to control costs and encourage utilization of certain drugs, including through the use of formulary inclusion, or favorable formulary placement. Such stakeholders have also increasingly imposed utilization management tools to favor the use of generic products or otherwise limit access to our products. As these practices expand, including due to potential further consolidation of U.S. private third-party payers, we may face difficulty in obtaining or maintaining timely or adequate pricing or formulary placement of our products. We expect that consolidation of supply chain entities will continue to increase competitive and pricing pressures on pharmaceutical manufacturers.

Pharmacy benefit manager practices have come under increased scrutiny from U.S. policymakers at the federal and state level who have proposed legislation intended to address concerns regarding the impact that these intermediaries have on drug pricing and patients’ out of pocket costs. If promulgated, such legislation could have resultant implications, costs, or consequences for our business and how we interact with these entities. For additional information on pricing and reimbursement for our pharmaceutical products, see Item 1, "Business—U.S. Private Sector Dynamics" and "Regulations and Private Payer Actions Affecting Pharmaceutical Pricing, Reimbursement, and Access—U.S."

Risks Related to Our Intellectual Property

•We depend on products with intellectual property protection for most of our revenues, cash flows, and earnings; the loss of effective intellectual property protection for certain of our products has resulted, and in the future is likely to continue to result, in rapid and severe declines in revenues for those products.

In the ordinary course of their lifecycles, our products lose significant patent protection and/or data protection in the U.S., as well as in key jurisdictions outside the U.S., after a specified period of time. Some products also lose patent protection as a result of successful third-party challenges. We have faced, and remain exposed to, generic competition following the expiration or loss of such intellectual property protection. For example, following the expiration of patent exclusivity for Alimta in Europe and Japan in June 2021, we have faced generic competition that has rapidly and severely eroded revenue from prior levels, and we expect such competition will continue to erode revenue from current levels in these markets. In addition, as a result of the entry of multiple generics in the U.S. following the expiration of patent and pediatric exclusivity for Alimta in in the first half of 2022, we began facing, and expect to continue to face, generic competition that has rapidly and severely eroded revenue from prior levels, and we expect will continue to erode revenue from current levels.

~~Certain other significant products no longer have effective exclusivity through patent protection or data protection.~~ For non-biologic products, loss of exclusivity (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. For biologics, ~~(such as Humalog, Humulin, Erbitux, Cyramza, Trulicity, Taltz, and Emgality),~~ loss of exclusivity may or may not result in the near-term entry of competitor versions (i.e., biosimilars) due to many factors, including development timelines, manufacturing challenges, and/or uncertainties regarding the regulatory ~~pathways for~~ approval ~~of the competitor versions. Generic pharmaceutical companies could also introduce a generic product before resolution of any related patent litigation.~~pathways.

There is no assurance that the patents we are seeking will be granted or that the patents we hold will be found valid and enforceable if challenged. Moreover, patents relating to particular products, uses, formulations, or processes do not preclude other manufacturers from employing alternative processes or marketing alternative products or formulations that compete with our patented products. Patents held by third-parties have also contributed, and may in the future contribute, to a decision by us to not pursue all potential indications for a product candidate. In addition, competitors or other third parties may assert claims that our activities infringe patents or other intellectual property rights held by them, or allege a third-party right of ownership in our existing intellectual property. See Item 7, "Management's Discussion and Analysis—Executive Overview—Other Matters—Patent Matters," and Item 1, "Business—Patents, Trademarks, and Other Intellectual Property Rights," for more details.

Patents relating to pharmaceutical products are often obtained early in the development process. Given the limited duration of patent and data protection, the speed with which we develop products, complete clinical testing, receive regulatory approval, supply commercial product 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 limits our ability to capitalize on the innovative medicines that we develop or acquire.

•Our long-term success depends on intellectual property protection; if our intellectual property rights are invalidated, circumvented, or weakened, our business will be adversely affected.

Our long-term success depends on our ability to continually discover or acquire, develop, and commercialize innovative medicines. 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 drugs and indications to the market. Intellectual property protection varies throughout the world and is subject to change over time, depending on local laws and regulations. Changes to such laws, regulations, and enforcement practices could reduce protections for our innovative products and indications. For example, ~~potential reforms~~a proposal by the European Commission to revise the EU's general pharmaceutical legislation ~~in the European Union may threaten~~threatens the predictability and length of certain pharmaceutical intellectual property ~~incentives.~~incentives, including by a two-year reduction of data package protection. Changes proposed by the USPTO and by certain bills in Congress to limit the number of, and differences between, patents obtained could also affect the scope of patent protection for our products in the U.S.

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.

Also in the U.S., in addition to the process for challenging patents set forth in the BPCIA, which applies to biologic products, the Hatch-Waxman Act provides generic companies substantial incentives to seek to invalidate our patents covering small molecule pharmaceutical products. As a result, we expect that our U.S. patents on major pharmaceutical products, including biologics, will continue to be routinely challenged in litigation

and may not be upheld. In addition, a separate IPR process currently allows competitors to seek invalidation of patents at the USPTO without the protections of the BPCIA or Hatch-Waxman Act. The use of IPR proceedings after the institution of litigation pursuant to the BPCIA or Hatch-Waxman Act is currently a topic of debate among legislators and the future ability of our competitors to use IPR proceedings as an alternative to Hatch-Waxman Act or BPCIA litigation procedures to challenge our patents remains uncertain. ~~Recently, the~~The USPTO issued an interim procedure regarding the use of discretionary denials of IPR proceedings when there is parallel district court litigation. However, it is not clear how this interim procedure could affect the ability of our competitors to institute IPR proceedings after institution of litigation. If our patents are challenged through this expedited review process, even if we prevail in demonstrating the validity of our patent, our win provides limited precedential value at the PTAB and no precedential value in federal district court, meaning the same patent can be challenged by other competitors.

We face many generic manufacturer challenges to our patents outside the U.S. as well. The entry of generic competitors typically results in rapid and severe declines in revenues. In addition, competitors or other third parties may claim that our activities infringe patents or other intellectual property rights held by them. If successful, such claims could result in our being unable to market a product in a particular territory or being required to pay significant damages for past infringement or royalties on future sales. In addition, intellectual property protection in certain jurisdictions outside the U.S. is weak and we face ~~additional~~heightened risks to our intellectual property rights in these jurisdictions, including competition with generic or counterfeit versions of our products at or relatively shortly after launch. See Item 1, "Business—Patents, Trademarks, and Other Intellectual Property Rights," and Item 8, "Financial Statements and Supplementary Data—Note 16: Contingencies," for more details.

•We also face challenges from the distribution of counterfeit and our products face intense competition 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.

We compete with a large number of multinational pharmaceutical companies, biotechnology companies, and generic pharmaceutical companies and, in many cases, our products compete against the leading products of one or more of our competitors. To compete successfully, we must continue to deliver to the market innovative, cost-effective products that meet important medical needs. Our product revenues can be adversely affected by the introduction by competitors of branded products that are perceived as superior by the marketplace, by generic or biosimilarillegally compounded 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 can also be adversely affected by treatment innovations, including new modalities, that eliminate or minimize the need for treatment with our drugs.

Regulation of generic and biosimilar products varies around the world and such regulation is complex and subject to ongoing interpretation and implementation by regulatory agencies and courts. Particularly for biosimilars, health authority guidelines and legislative actions could make it less burdensome for competitor products to enter the market and further incentivize uptake of biosimilars. In the U.S., the FDA has issued several "interchangeability" designations for biosimilar products, and is expected to continue doing so in the future. These designations could – subject to state law requirements – enable pharmacies to substitute biosimilars for innovator biological products. Given the importance of biologic products to our clinical-stage pipeline, such regulation could have a material adverse effect on our business. See Item 1, "Business—Competition" and "Business—Research and Development," for more details.

In addition, we rely on our ability to attract, engage, and retain highly qualified and skilled personnel in order to compete effectively. 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, 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. Our ability to attract and retain talent in our increasingly competitive environment may be further complicated by evolving employment trends,genuine drugs, including as related to ~~increased preferences for remote~~our products with GLP-1 receptor agonist activity. Counterfeits, and in some cases illegally compounded drugs, fraudulently claim to be, or ~~flexible work arrangements; public~~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 ~~outbreaks, epidemics,~~risks to patients. Our reputation and business could suffer harm from counterfeit or ~~pandemics, such as the COVID-19 pandemic; political, social, civil,~~illegally compounded drugs and our actions to stop or cultural unrest; emergence or escalation of, and responses to, war and unrest; or the threat of or perceived potential for any of the foregoing events. Our failure to compete effectively for talent could negatively affectprevent illegal sales of ~~our current and any future~~such drugs may be costly or ineffective.

~~approved products, and could result in material financial, legal, commercial, or reputational harm~~Risks Related to ~~our business.~~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.

~~A great deal of~~Important confidential information owned by us, or our business partners, or other third parties is stored in our information systems, networks, and facilities or those of third parties. This includes valuable trade secrets and intellectual property, clinical trial information, corporate strategic plans, marketing plans, customer information, and personally identifiable information, such as employee and patient information (collectively, confidential information). We also rely, to a large extent, on the efficient and uninterrupted operation of complex information technology systems, infrastructure, cloud technologies, and hardware (together, IT systems), some of which are within our control and some of which are within the control of third parties, to accumulate, process, store, and transmit large amounts of confidential information and other data. We are subject to a variety of ~~continuously~~ evolving and developing laws and regulations around the world related to privacy, data protection, and data security. Maintaining the security, confidentiality, integrity, and availability of our IT systems and confidential information is vital to our business. Our failure, or the failure of our third-party service providers, to protect and maintain the security, confidentiality, integrity, and availability of our (or their) IT systems and ~~our~~ confidential information and other data could significantly harm our reputation as well as result in significant costs, including those related to fines, penalties, litigation, and obligations to comply with applicable data breach laws.

IT systems are inherently vulnerable to system inadequacies, inadequate controls or procedures, operating failures, unauthorized access, service interruptions or failures, security breaches, malicious intrusions, theft, exfiltration, ransomware, or cyber-attacks from a variety of sources, which may remain

undetected for significant periods of time. ~~Such vulnerabilities,~~From time to time, we update, transition, acquire, or expand use of our and third-party IT systems, which may result in heightened vulnerability. Some third-party IT systems that are necessary for the operation of our business processes are maintained outside of our control but would impact business operations if compromised as a result of a cyber-attack. 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. See Item 9A, "Controls and Procedures" for more details. Vulnerabilities, inadequacies, or failures are in many cases more acute for IT systems associated with recently acquired businesses, and we may be unable to entirely address such vulnerabilities, inadequacies, or failures immediately after acquiring a ~~business.~~business or ever. As a result, our newly acquired businesses ~~could be~~are in some cases more vulnerable to ~~potential~~failures, interruptions, breaches, intrusions, theft, exfiltration, or attacks.

Cyber-attacks are growing in their frequency, sophistication, and intensity, and are becoming increasingly difficult to detect, mitigate, or prevent. Cyber-attacks come in many forms, including the deployment of harmful malware, exploitation of vulnerabilities (including those of third-party software or systems), denial-of-service attacks, the use of social engineering, and other means to compromise the confidentiality, integrity, and availability of ~~our~~ IT systems, confidential information, and other data. Breaches resulting in the compromise, disruption, degradation, manipulation, loss, theft, exfiltration, destruction, or unauthorized disclosure or use of confidential information, or the unauthorized access to, disruption of, or interference with, or attack of, our IT systems, products and services, can occur in a variety of ways, including negligent or wrongful conduct by employees or others with permitted access to our systems and information, or wrongful conduct by hackers, competitors, ~~certain~~ governments, nation-states, state-sponsored or ~~nation-states, or other~~affiliated groups, current or former company ~~personnel.~~personnel, and other actors. Our third-party partners, including third-party providers of data hosting or cloud services, as well as suppliers, distributors, alliances, and other third parties with whom we may share data, face similar risks, which could affect us directly or indirectly. Unassociated third parties present further risks, including by propagating misinformation related to our products, business, and ~~industry. The~~industry, including through social media. We and others in the healthcare industry ~~has~~have been and ~~continues~~continue to be ~~a target~~targets for cyber-attacks, and the number of threats has increased over time. Numerous federal agencies that monitor and regulate internet and cyber-crime have issued guidance, alerts and directives warning of software vulnerabilities that require immediate patching, malicious actors targeting healthcare-related systems and nation-state sponsored hacking designed to steal valuable information.

The failure, inadequacy, or breach of our IT systems or business processes, 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 our ability to secure and maintain intellectual property rights; result in a product manufacturing interruption or failure, or in the interruption or failure of products or services that rely on IT systems or business processes; damage our operations, ~~customer~~patient and other relationships, or reputation; undermine integration activities or otherwise delay or prevent the launch of acquired products; result in unfavorable clinical trial results by virtue of incorrect or unreliable data; expose us to ransom payment, other demands, or paralyze our operations; give rise to legal liability and regulatory action under data protection and privacy laws; require disclosure to government authorities and/or regulators; expose us to civil and criminal investigations; and/or cause us to lose trade secrets or other competitive ~~advantages.~~advantages, which effects could endure for a long period of time. Unauthorized disclosure of personally identifiable information could further expose us to significant sanctions for violations of data privacy laws and

regulations around the world, subject us to litigation, and ~~could~~ damage public trust in our company. In addition, IT system security in jurisdictions outside the U.S. is weaker and may result in additional costs, uncertainties, and risks.

We are subject to various laws and regulations globally regarding privacy and data protection, including laws and regulations relating to the collection, storage, handling, use, disclosure, transfer, and security of personal information. The legislative and regulatory environment regarding privacy and data protection is continuously evolving and the subject of significant attention by regulators and private parties globally. Regulators are imposing new data privacy and security requirements, including new and greater monetary fines or penalties for privacy violations, and jurisdictions where we operate have passed, or continue to propose, data privacy legislation and/or regulations. For example, we are subject to existing laws in the EU, United Kingdom, China, and U.S., all of which provide for substantial penalties for

noncompliance. Other jurisdictions where we operate have passed, or continue to propose, similar legislation and regulations. Failure to comply with these current and future laws could result in significant penalties and reputational harm and could have a material adverse effect on our business and results of operations.

To date, system inadequacies, inadequate controls or procedures, operating failures, unauthorized access, service interruptions or failures, security breaches, malicious intrusions, theft, exfiltration, ransomware, cyber-attacks, and the compromise, disruption, degradation, manipulation, loss, theft, exfiltration, destruction, or unauthorized disclosure or use of confidential information, or the unauthorized access to, disruption of, interference with, or attack of, our IT systems, products and services have not had a material impact on our ~~consolidated~~business strategy, results of ~~operations.~~operations or financial condition. We maintain cyber liability insurance; however, this insurance may not be sufficient to cover the financial, operational, legal, business, or reputational losses that may result from an interruption or breach of our IT systems. We continue to implement measures in an effort to protect, detect, respond to, and minimize or prevent these risks and to enhance the resiliency of our IT systems; however, these measures may not be successful, and we may fail to detect or remediate system inadequacies, inadequate controls or procedures, operating failures, unauthorized access, service interruptions or failures, security breaches, malicious intrusions, theft, exfiltration, ransomware, cyber-attacks, or other compromises of our systems. Any of these events could result in material financial, operational, legal, ~~commercial,~~business, or reputational harm to our business.

•~~Economic downturns or international trade and other global disruptions or disputes could adversely affect our business and operating results.~~

~~Economic slowdowns could lead to decreased utilization~~ For a discussion of our products, affecting our sales. Declining tax revenues and increased government spending on other programs attributable to economic downturns increase the pressure on governments to reduce healthcare spending, leading to increased controlmanagement of drug prices or lower utilization. Additionally, some customers, including governments or other entities reliant upon government funding, may be unable to pay for our products fully or in a timely manner. Also, if our customers, suppliers, or collaboration partners experience financial difficulties, we could experience slower customer collections, greater bad debt expense, and performance defaults by suppliers or collaboration partners. Similarly significant economic downturns could limit our ability to access capital markets.

In addition, significant portions of our business are conducted in Europe (including the United Kingdom), Asia (including China), and other international geographies. Trade and other global disputes and interruptions in international relationships, including related to tariffs, trade protection measures, import or export licensing requirements, the imposition of trade sanctions or similar restrictions by the U.S. or other governments, unrest or war, as well as public health outbreaks, epidemics, or pandemics, such as the COVID-19 pandemic, affect our ability to do business. For example, tensions between the U.S. and China have led to a series of tariffs and sanctions being imposed by the U.S. on imports from China mainland, as well as other business restrictions. As a further example, the financial impact of higher energy prices, defense spending, and inflation due, in part, to the Russia-Ukraine war and resulting geopolitical and economic disruptions, particularly following the COVID-19 pandemic, has further exacerbated financial pressures on governments with single-payer or government funded healthcare systems, leading to increased impetus for increases in rebates, clawbacks, and other reforms to reimbursement systems, particularly in Europe. These and similar events have adversely affected, and may continue to adversely affect, us, our business partners, and our customers. For more details,cybersecurity risks, see Item ~~1, "Business—Regulations~~1C, "Cybersecurity—Risk Management and ~~Private Payer Actions Affecting Pharmaceutical Pricing, Reimbursement,~~Strategy" and ~~Access.~~"—Governance."

•~~Pharmaceutical products can develop unexpected safety or efficacy concerns, which could have a material adverse effect on our revenues, income, and reputation.~~

Pharmaceutical products receive regulatory approval based on data obtained in controlled clinical trials of limited duration. After approval, the products are used for longer periods of time by much larger numbers of patients. Accordingly, we and others (including regulatory agencies and private payers) collect extensive information on the efficacy and safety of our marketed products by continuously monitoring the use of our products in the marketplace. In addition, we or others may conduct post-marketing clinical studies on efficacy and safety of our marketed products. New safety or efficacy data from both market surveillance and post-marketing clinical studies may result in product label changes or other measures that could reduce the product's market acceptance and result in declining sales. Serious safety or efficacy issues that arise after product approval have, and could in the future, result in voluntary or mandatory product recalls or withdrawals from the market. Safety issues have, and could in the future, result in costly product liability claims.

•We face litigation and investigations related to our products, how we price our products, and how we commercialize our products; we could face large numbers of claims in the future, which could adversely affect our business, and we are self-insured for such matters.

We are subject to a substantial number of claims involving various current and historical products, litigation and investigations. These claims relate to how we commercialize and/or how we price our products, including relating to our 340B drug pricing program, as well as contractual matters and other disputes. See Item 8, "Financial Statements and Supplementary Data—Note 16: Contingencies" for more information on our current product liability litigation, as well as pricing and other litigation, investigations, and inquiries. Because of the nature of pharmaceutical products, we are, and could in the future become, subject to large numbers of product liability claims for our previous, current, or future products, or to further litigation or investigations, including related to pricing or other commercial practices. Such matters could affect our results of operations or require us to recognize substantial charges to resolve and, if involving marketed products, could adversely affect sales of the product and our consolidated results of operations in any given period. Due to a very restrictive market for liability insurance, we are self-insured for litigation liability losses for all of our currently marketed products, as well as for litigation or investigations related to our pricing practices or other similar matters.

•Manufacturing, quality, or supply chain difficulties, disruptions, or shortages could lead to product supply problems.

We are in the midst of a significant expansion of our manufacturing capabilities and substantial investment in long-term supply agreements to support current and anticipated demand for our products. Pharmaceutical manufacturing is complex and highly regulated. Manufacturing or quality assurance difficulties at our facilities or those of our contractors and suppliers, the failure or refusal of a supplier or contract manufacturer to supply contracted quantities, or increases in demand on a supplier with constrained capacity could result in delays and disruptions in the manufacturing, distribution, and sale of our products and/or product shortages, leading to lost ~~revenue.~~revenue or reduced marked opportunities. In select cases, supply constraints may also lead to pauses, discontinuations, or other product availability issues in one or more markets, which could have a material adverse effect on our consolidated results of operations, cash flows, and ~~cash flows.~~reputation. Further, cost inflation and global transportation and logistics challenges, as well as tight labor markets, have caused, and in the future may cause, delays in, and/or increase costs related to, distribution of our medicines, the construction or other acquisition of additional manufacturing capacity, procurement activity, and supplier or contract manufacturer arrangements. ~~Such difficulties,~~These disruptions orand challenges could result from actual or perceived quality, oversight, or regulatory compliance problems; natural disasters (including increased instances or severity of natural disasters or other events that may be due to climate change), public health outbreaks, epidemics, or ~~pandemics (such as the COVID-19 pandemic);~~pandemics; periods of ~~global~~uneven economic ~~downturn~~growth or ~~uncertainty;~~downturns; emergence or escalation of, and responses to ~~war or unrest (including the Russia-Ukraine war);~~international tension and conflicts; equipment, mechanical, data, or IT system vulnerabilities, such as system inadequacies, inadequate controls or procedures, operating failures, unauthorized access, service interruptions or failures, security breaches, malicious intrusions, theft, exfiltration, ransomware or other cyber-attacks from a variety of sources; labor shortages; challenges and complexities in manufacturing new drug modalities; contractual disputes with our suppliers and contract manufacturers; vertical integration by competitors within our supply chain; or inability to obtain single-source or other raw or intermediate materials. Regional or single source dependencies may in some cases accentuate risks related to manufacturing and supply. For example, we, and the pharmaceutical industry generally, depend on China-based partners for integral chemical synthesis, reagents, starting materials, and ingredients. Finding alternative suppliers if and as necessary due to geopolitical developments or otherwise may not be feasible or could take a significant amount of time and involve significant expense due to the nature of our products and the need to obtain regulatory approvals which would cause disruptions to patients and detrimentally impact our business.

Difficulties in predicting or variability in demand for our products and those of our competitors and the very long lead times necessary for the expansion and regulatory qualification of pharmaceutical manufacturing capacity have resulted, and in the future may result, in difficulty meeting demand, ~~for,~~ or disruptions, shortages, and higher costs in the supply of, our products. 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.~~therapies, and expect tight supply to persist while additional manufacturing capacity is operationalized. Despite our ongoing efforts to meet significant expected demand by obtaining additional internal and contracted manufacturing capacity, there can be no assurances that such capacity increases will be realized as expected. Delays or challenges in operationalizing additional manufacturing capacity would limit our ability to capitalize on ~~expected demand.~~demand for our products. Conversely, unexpected ~~contingencies~~events that limit demand for our ~~incretin~~ products would undermine our ability to realize the full benefit of significant capital expenditures that we have incurred, and expect to continue to incur, to augment manufacturing capacity and may also subject us to contractual payment ~~obligations.~~obligations, which may be significant. The foregoing risks and uncertainties could negatively impact our consolidated results of operations and reputation. See Item 1, "Business—Raw Materials and Product Supply," and Item 7, "Management's Discussion and Analysis—Financial Condition and Liquidity" for more details.

•We derive a significant percentage of our total revenue from relatively few products and sell our products through increasingly consolidated supply chain stakeholders, which may subject us to, or exacerbate, various risks.

We derived direct product and/or alliance revenues of more than $1 billion for each of Trulicity, Verzenio, Taltz, Jardiance (including Glyxambi, Synjardy, and Trijardy XR), Humalog (including Insulin Lispro), our COVID-19 antibodies, and Humulin that collectively accounted for 69 percent of our total revenues in 2022. In particular, Trulicity accounted for 26 percent of our total revenues in 2022 and we expect GLP-1s, including Mounjaro, which we launched in 2022, to represent a significant and growing portion of our business. Loss of patent protection, changes in prescription rates, material product liability litigation, unexpected side effects or safety concerns, significant changes in demand, regulatory proceedings, negative publicity affecting doctor or patient confidence, pressure from existing or new competitive products, changes in labeling, pricing, and access pressures, or supply shortages or disruptions for these products or any of our other major products could materially impact our results of operations.

Moreover, the negotiating power of health plans, managed care organizations, pharmacy benefit managers, and other supply chain stakeholders has increased due to consolidation, regulatory, and other market impacts, and they, along with governments, increasingly employ formularies to control costs and encourage utilization of certain drugs, including through the use of formulary inclusion, or favorable formulary placement. Such stakeholders have also increasingly imposed utilization management tools favoring the use of generic products. As these practices expand, including due to potential further consolidation of U.S. private third-party payers, we may face difficulty in obtaining or maintaining timely or adequate pricing or formulary placement of our products. We expect that consolidation of supply chain stakeholders will continue to increase competitive and pricing pressures on pharmaceutical manufacturers. For additional information on pricing and reimbursement for our pharmaceutical products, see "U.S. Private Sector Dynamics" and "Regulations and Private Payer Actions Affecting Pharmaceutical Pricing, Reimbursement, and Access—U.S."

•Reliance on third-party relationships and outsourcing arrangements could adversely affect our business.

We rely on third parties, including suppliers, distributors, alliances, and collaborations with other pharmaceutical and biotechnology companies, and third-party service providers, for selected aspects of product and clinical development, manufacturing, commercialization, hosting of, and support for, IT systems, product distribution, and certain financial transactional processes. As examples, we outsource the day-to-day management and oversight of some of our clinical trials to contract research organizations, certain active ingredient manufacturing, finishing operations, and device or component production and assembly to contract manufacturing organizations, and the distribution of our products through logistics providers. In some cases, product or indication approvals depend on the outcome of regulatory inspections of third parties on which we rely. 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. We may encounter similar difficulties in the future, which could delay or prevent product launches and otherwise negatively affect our business, results, and reputation.

Outsourcing involves many risks, including the risk that ~~the~~ third parties may not perform to our standards or legal requirements, including applicable requirements for diversity in clinical trials; may not produce reliable results; may not perform in a timely manner; may not maintain the confidentiality, integrity, and availability of confidential and proprietary information relating to us, our clinical trial subjects, or patients; may experience disruption or fail to perform due to IT system vulnerabilities, ~~breaches, cyber-attacks, or~~such as inadequacies, inadequate controls or ~~procedures;~~procedures, operating failures, unauthorized access, service interruptions or failures, security breaches, malicious intrusions, theft, exfiltration, ransomware or other cyber-attacks; may be unable to satisfy their commitments to us in which case we may not be able to achieve acceptable alternative sourcing; or may fail to perform at all. The foregoing risks may be heightened in jurisdictions outside the U.S., where we may have fewer alternative providers as well as face additional costs, uncertainties, and risks. Failure of third parties to meet their contractual, regulatory, confidentiality, privacy, security, or other obligations to us, our clinical trial subjects, and our patients could have a material adverse effect on our business.

•~~Public health outbreaks, epidemics,~~Our use of artificial intelligence (AI) or ~~pandemics, such as the COVID-19 pandemic, have adversely impacted and may in the future~~other emerging technologies could adversely impact our business and ~~operations.~~financial results.

~~Actual~~We have begun to deploy AI and other emerging technologies in various facets of our operations and we continue to explore further use cases for AI. The rapid advancement of these technologies presents opportunities for us in research, manufacturing, commercialization, and other business endeavors but also entails risks, including that AI-generated content, analyses, or ~~threatened~~recommendations we utilize could be deficient, that our competitors may more quickly or effectively adopt AI capabilities, or that our use of AI or other emerging technologies exacerbates regulatory, cybersecurity and other significant risks.

Effective development, management, and use of AI technologies is novel and complex, and there are technical challenges associated with achieving desired levels of accuracy, efficiency, and reliability. The algorithms and models utilized in AI systems may have limitations, including biases, errors, or inability to handle certain data types or scenarios or to render explainable outputs. Furthermore, there are risks associated with the fact that the platforms providing AI models are in many cases owned and operated by emerging companies with less contractual and compliance sophistication. These factors may undermine

our ability to effectively utilize AI or create competitive disadvantages should our competitors more skillfully make use of AI capabilities. Further, if we are unable to effectively manage the use of AI technologies by our employees, our confidential information, intellectual property, or reputation could be put at risk.

The emergence of AI and other technologies, particularly generative AI, may exacerbate other risks, including those related to regulation, litigation, compliance issues, ethical concerns, confidentiality, and data privacy or security. For example, regulatory uncertainty related to AI or other emerging technologies may require significant resources to adjust business practices to comply with developing laws. Several governmental authorities have already proposed or enacted laws and other guidance governing AI, such as the proposed EU Artificial Intelligence Act. These and other developing obligations may prevent or make it harder for us to conduct or enhance our business using AI, or lead to regulatory fines, penalties, or other liability. Further, use of AI technologies could lead to unintended consequences, such as cybersecurity risks or unintended biases, impact our ability to protect our confidential data and intellectual property, and expose us to intellectual property infringement claims by third parties.

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.

Economic slowdowns could lead to decreased utilization of our products, affecting our sales. Declining tax revenues and increased government spending on other programs attributable to uneven economic growth or downturns increase the pressure on governments to reduce healthcare spending, leading to increased control of drug prices or lower utilization. Additionally, some customers, including governments or other entities reliant upon government funding and cash-pay patients, may be unable to pay for our products fully or in a timely manner. Also, if our customers, suppliers, or collaboration partners experience financial difficulties, we could experience slower customer collections, greater bad debt expense, and performance defaults by suppliers or collaboration partners. Similarly, uneven economic growth or downturns could limit our ability to access capital markets.

In addition, significant portions of our business are conducted in Europe, Asia, and other international geographies. Trade and other global disputes and interruptions, including related to tariffs, trade protection measures, import or export licensing requirements, the imposition of trade sanctions or similar restrictions by the U.S. or other governments, international tension and conflicts, as well as cost inflation, strains on global transportation, manufacturing, and labor markets, and public health outbreaks, epidemics, or pandemics, such as the COVID-19 pandemic, affect our ability to do business. For example, tensions between the U.S. and China have led to a series of tariffs and sanctions being imposed by the U.S. on imports from China mainland, as well as other business restrictions. If geopolitical tensions were to increase and disrupt our operations in, or related to, China, such disruption would significantly impact our business. As a further example, the financial impact of higher energy prices, defense spending, and inflation due, in part, to geopolitical and economic disruptions, has further exacerbated financial pressures on governments with single-payer or government funded healthcare systems, leading to increased impetus for increases in rebates, clawbacks, and other reforms to reimbursement systems, particularly in Europe. These and similar events have adversely ~~impacted and may in the future adversely impact our business and operations. The~~

~~COVID-19 pandemic has adversely impacted~~affected, and may continue to adversely ~~impact~~affect, us, our business ~~and operations across markets to varying and fluctuating degrees, including as a result of:~~

•Cost inflation and strain on global transportation, manufacturing, and labor markets, which have negatively impacted development, manufacturing, supply, distribution, and sales of our medicines, including through increased costs to provide, and in some cases disruptions in supply or shortages of, our medicines.

•~~Fewer in-person interactions among patients and healthcare providers~~partners, and our ~~employees with healthcare professionals in certain markets.~~

•Pricing pressures, rebates, clawbacks, and other changes in reimbursement policies and programs resulting, in part, from the financial strain of the COVID-19 pandemic on government-funded healthcare systems around the world.

•Risks related to our COVID-19 therapies, including heightened regulatory scrutiny of our manufacturing practices, quality assurance, and similar regulations; restrictions on administration that limit widespread and timely access to our therapies, and risks related to handling, return, and/or refund of product after delivery by us; concerns related to expedited authorization of restricted distribution of products with less than typical safety and efficacy data; and fluctuations in, or elimination of, demand for our COVID-19 therapies, including based on the availability of superior or competitive therapies, preventative measures such as vaccines and antiviral medicines, mutations of the virus impacting effectiveness, revocations or restrictions on EUAs, reaching endemic status in different jurisdictions, reduced government and payer funding for COVID-19 therapies, the unpredictable nature of pandemics, and other developments.

These and other risks related to the COVID-19 pandemic and other actual or threatened public health outbreaks, epidemics, or pandemics could affect other aspects of our business or intensify other risks inherent in our business. The degree to which the COVID-19 pandemic could continue to affect us and other actual or threatened public health outbreaks, epidemics, or pandemics could affect us, will depend on developments that are highly uncertain and beyond our knowledge or control, including the duration and severity of the public health threat, the actions taken to reduce its transmission, the introduction and spread of new variants, the degree and extent of government restrictions on economic activity, government spending, and access to healthcare, and the speed with which, and extent to which, economic and operating conditions recover. Should the COVID-19 pandemic, or any other actual or threatened public health outbreak, epidemic, or pandemic, as well as any associated or resulting cost of inflation, supply chain disruption, labor market impact, recession, depression, or other negative contingency, continue for a prolonged period, these risks could be exacerbated, causing further impact on our business and operations.

~~Risks Related to Government Regulation~~

Public and private payers continue to take aggressive steps to control their expenditures for pharmaceuticals by placing restrictions on pricing and reimbursement for, and patient access to, our medicines. These pressures have negatively affected, and could continue to negatively affect, our consolidated results of operations. Governments and private payers worldwide have intensified their scrutiny of, and actions intended to address, pricing, reimbursement, and access to pharmaceutical products. Additional policies, regulations, legislation, or enforcement, including as a result of the regulatory priorities of the current U.S. presidential administration and regulatory authorities worldwide, could adversely impact our business and consolidated results of operations. In particular, if one or more of our significant products are selected under the IRA, the resulting price reduction and reimbursement could negatively impact our business and consolidated results of operations.customers. For more details, see Item 1, "Business—Regulations and Private Payer Actions Affecting Pharmaceutical Pricing, Reimbursement, and Access."

Further, restrictive or unfavorable pricing, coverage, or reimbursement determinations for our medicines or product candidates by governments, regulatory agencies, courts, or private payers, such as the Alzheimer’s Monoclonal Antibody NCD, may adversely impactIn addition to developments related to our business or financial results, or those of our competitors, uneven economic growth, downturns, or other negative global developments, could also undermine our growth or result in significant and ~~financial results. We~~

~~continue to experience additional pricing pressures, rebates, clawbacks,~~sudden declines in the trading price of our common stock and other changes in reimbursement policies and programs resulting from the financial strain of the COVID-19 pandemic, periods of global economic downturn or uncertainty, and the emergence or escalation of, and responses to, war or unrest (including the Russia-Ukraine war).

•Changes in foreign currency rates, interest rate risks, orand inflation affect our results of operations.

As a global company, we face foreign currency risk exposure from fluctuating currency exchange rates, interest rate risk from our exposure to floating and variable interest rates, and inflation risk from existing and expected rates of inflation in the U.S. and other jurisdictions, each of which impacts our results of operations. In recent periods, significant fluctuations in currency rates and inflation have ~~had a significant negative impact on~~impacted our results of operations. We are a net receiver of foreign currencies, and our results of operations ~~may continue to be~~ are

adversely impacted ifwhen the U.S. dollar ~~remains~~is strong compared to foreign currencies. Further, in the event of an extreme devaluation of local currency in a particular market in which we operate, the price of our products could become unsustainable in the relevant market. Inflationary pressures in recent periods have also negatively impacted us and may continue to negatively impact us in various ways, including cost inflation, higher labor costs, and other higher expenses, with some of these higher expenses due in part to policy actions intended to curb inflation. See Item 7, "Management's Discussion and Analysis—Financial Condition and Liquidity" and Item 8, "Financial Statements and Supplementary Data—Note 1: Summary of Significant Accounting Policies and Implementation of New Financial Accounting Standards," for more details.

Risks Related to Government Regulation and Litigation

•We face litigation and investigations related to our products, how we price or commercialize our products, and other aspects of our business, which could adversely affect our business, and we are self-insured for such matters.

We are subject to a substantial number of claims involving various current and historical products, litigation, and investigations. These claims relate to how we commercialize and/or how we price our products, including relating to our 340B drug pricing program, product safety, as well as contractual matters and other disputes. See Item 8, "Financial Statements and Supplementary Data—Note 16: Contingencies" for more information on our current product liability litigation, as well as pricing and other litigation, investigations, and inquiries. Like many companies in our industry, from time to time investigations into aspects of our business include inquiries, subpoenas, and other types of information demands from government and regulatory authorities. There continues to be a significant volume of government and regulatory investigations and litigation against companies operating in our industry, as well as increasingly robust regulatory enforcement. Because of the nature of pharmaceutical products, we are, and could in the future become, subject to large numbers of product liability claims for our previous, current, or future products, or to further litigation or investigations, including related to product safety and pricing or other commercial practices. Some of these matters involve numerous plaintiffs and parties seeking large or indeterminate financial claims and may remain unresolved for several years. Such matters could negatively impact our reputation, affect our results of operations or require us to recognize substantial charges to resolve and, if involving marketed products, could adversely affect sales of the product and our consolidated results of operations in any given period. Due to a very restrictive market for liability insurance, we are predominately self-insured for litigation liability losses for all of our currently marketed products, as well as for litigation or investigations related to our pricing practices or other similar matters.

•We are subject to evolving and complex tax laws, which may result in additional liabilities and affect our results of operations.

We are subject to income taxes in the U.S. and numerous other jurisdictions, and in the course of our business, we make judgments about the expected tax treatment of various transactions and events. Changes in tax laws, regulations, administrative practices, principles, disclosure obligations, and interpretations, as well as events that differ from our expectations, have affected and may adversely affect our effective tax rates, cash flows, and/or results of operations. Significant uncertainty currently exists regarding tax proposals introduced by the current U.S. administration and Congress, including modifications to certain aspects of the Tax Cuts and Jobs Act of 2017, such as the potential repeal or deferral of the provision requiring capitalization of research and development expenses. In addition, tax authorities in the U.S. and other jurisdictions in which we do business routinely examine our tax returns and are intensifying their scrutiny and examinations of ~~profit allocations among jurisdictions,~~cross-border tax issues, which could unfavorably impact our results of operations. Further, actions taken with respect to tax-related matters by associations such as the Organisation for Economic Co-operation and Development and the European Commission could influence tax laws in countries in which we ~~operate.~~operate, such as the recent enactments by both the EU and non-EU countries of a global minimum tax. Modifications to key elements of the ~~current~~ U.S. or international tax framework could have a significant impact on our effective tax rate, results of operations, and cash flows. See Item 7, "Management's Discussion and Analysis—Executive Overview—Other Matters—Tax Matters" and Item 8, "Financial Statements and Supplementary Data—Note 14: Income Taxes," for more details.

•Regulatory compliance problems could be damaging to the company.

The marketing, promotional, and pricing practices of pharmaceutical manufacturers, as well as the manner in which manufacturers interact with purchasers, prescribers, and patients, are subject to extensive scrutiny and regulation. Many companies, including us, are and have been subject to investigations, litigation, and claims related to these practices asserted by ~~federal, state, and foreign~~ governmental authorities ~~private payers,~~ and ~~consumers.~~

other parties. These investigations, litigation, and claims have resulted in substantial expense and other significant ~~consequences to us. We are, and could in the future become, subject to~~consequences. The final outcomes of such investigations, litigation, and claims ~~the outcomes of which~~ include criminal charges and fines, penalties, or other monetary or non-monetary remedies, including exclusion from U.S. federal and other healthcare programs. Such investigations, litigation, and claims have intensified and may continue to intensify as a result of ~~the~~evolving U.S. and foreign regulatory ~~priorities of each particular U.S. presidential administration~~priorities. New business practices or commercial capabilities may subject us to additional scrutiny over compliance with applicable regulatory schemes and ~~other~~compliance obligations or expose us to new regulatory ~~authorities worldwide.~~schemes and compliance obligations entirely. In addition, regulatory issues concerning compliance with cGMP, quality assurance, evolving standards, and increased scrutiny around excipients and potential impurities such as nitrosamines, and

similar regulations and standards (and comparable foreign regulations and standards) for our products ~~can~~in some cases lead to regulatory and legal actions, product recalls and seizures, fines and penalties, interruption of production leading to product shortages, import bans or denials of import certifications, delays or denials in new product approvals or line extensions or supplemental approvals of current products pending resolution of the issues, and reputational harm, any of which ~~would~~ adversely ~~affect~~affects our business. Regulatory oversight of the pharmaceutical industry entails judgment and interpretation, which can result in inconsistent administration of laws and regulations by health authorities. Regulatory compliance and processes in jurisdictions outside the U.S. may ~~also~~ be ~~less predictable~~particularly unpredictable and result in additional costs, uncertainties, and ~~risks.~~risks.U.S. and foreign governmental authorities are actively promulgating additional regulations that impact many aspects of our operations. These regulations are in some cases advanced with short notice. New regulations may undermine our ability to achieve business objectives, may be costly to implement, may provide only limited time for compliance, may change accounting and reporting standards, and may carry significant penalties for non-compliance. See Item 1, "Business—Government Regulation of Our Operations," for more details.

Furthermore, there is an increased focus by foreign, federal, state, and local regulatory and legislative bodies regarding environmental policies relating to climate change, regulating greenhouse gas emissions, carbon taxes, emissions trading schemes, ~~sustainable manufacturing,~~sustainability, human rights and equity matters, and disclosure regarding the foregoing, many of which may be ambiguous, inconsistent, dynamic or conflicting. We expect to experience increased restrictions and compliance costs, legal costs, and expenses related to such new or changing legal or regulatory requirements. Moreover, compliance with any such legal or regulatory requirements would require us to devote substantial time and attention to these matters. In addition, we may still be subject to penalties or potential litigation if such laws and regulations are interpreted or applied in a manner inconsistent with our practices.

Additionally, we are subject to increased negative attention from the media, stockholders, activists, and other stakeholders on climate change, social, and sustainability matters. The perception that we have failed to act in a socially responsible manner, whether or not valid, results in adverse publicity that can negatively affect our business, brand, and reputation, as well as result in increased scrutiny from legislators and regulatory authorities. Moreover, from time to time we establish and publicly announce goals and commitments, including to reduce our impact on the environment. Our ability to achieve any stated environmental, social or governance goal, target or objective is subject to numerous factors and conditions, many of which are outside our control. Examples of such factors include evolving regulatory requirements affecting sustainability standards or disclosures or imposing different requirements, the availability of requisite financing, and the availability of suppliers that can meet our sustainability and other goals. If we fail to achieve, are perceived to have failed or been delayed in achieving, or improperly report our progress toward achieving these goals and commitments, it could negatively affect our reputation, brand, or investor confidence, and expose us to enforcement actions and litigation.

3335

Item 1B.Unresolved Staff Comments

None.

Item 1C.Cybersecurity

Risk Management and Strategy

We manage cybersecurity threats as part of our oversight, evaluation, and mitigation of enterprise-level risks. We have based our cybersecurity program on industry frameworks with the goal of building enterprise resilience against an evolving landscape of cybersecurity threats and to respond to cybersecurity threats as they materialize. Our program includes monitoring, identification, assessment, and management components, as well as information and escalation components designed to inform management and the board of directors of prospective risks and developments.

Our information security program encompasses functions dedicated to both proactive and reactive management of cybersecurity threats. We implement our cybersecurity program internally through established policies, standards, reference architectures, and the use of enterprise security services that focus on emerging and ongoing cybersecurity risks. Our proactive management of cybersecurity risks entails many actions, including the maintenance of system access restrictions, utilization of data security technology, employee education and training initiatives, and retention of cyber liability insurance, among other measures. We regularly engage third-party auditors and consultants and leverage our internal audit function to assess various facets of our cybersecurity program. These engagements include completion of industry-standard assessments or certifications, maturity model reviews, threat simulations, as well as internal reviews to assess the effectiveness of our cybersecurity processes. We also maintain enterprise-wide processes to oversee and identify risks from cybersecurity threats associated with our use of third-party service providers. As examples, we generally review current and prospective third-party service providers for unacceptable cybersecurity risks, negotiate contractual provisions that require the establishment of third-party cybersecurity controls, and deploy communications security measures to protect third-party communications.

We assess cybersecurity contingencies within our overall business continuity risk management planning process. Our Information Security team utilizes various tools to prevent, detect, monitor, and react to cybersecurity threats. Our Incident Response Playbook outlines processes, roles, responsibilities, engagements, escalations, notifications, and other communications applicable to the assessment, mitigation, and remediation of realized cybersecurity events. The nature and assessed risk of a realized cybersecurity event dictates the pace and extent of relevant processes, escalations, and communications, including an evaluation of any necessary or required disclosure. Roles and escalation paths range from within the Information Security team up to the Executive Committee, and the board of directors and its committees, as appropriate.

We describe risks faced by us from identified cybersecurity threats in Item 1A, "Risk Factors—Risks Related to Our Operations— Failure, inadequacy, breach of, or unauthorized access to, our IT systems or those of our third-party service providers, unauthorized access to our confidential information, or violations of data protection laws, could 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 problems" and "Risk Factors—Risks Related to Our Operations—Reliance on third-party relationships and outsourcing arrangements could adversely affect our business."

Governance

Management, under the supervision of our Chief Information Security Officer (CISO), is directly responsible for assessing and managing cybersecurity risks and otherwise implementing our cybersecurity program, which includes our Incident Response Playbook. The CISO reports directly to our Chief Information and Digital Officer (CIDO), who is a member of our Executive Committee and leads our information technology, cybersecurity, digital health, and advanced analytics and data science functions. Our CIDO in turn regularly updates our Executive Committee on cybersecurity matters. Our CISO and CIDO have significant experience managing global cybersecurity threats across the pharmaceutical, technology, entertainment, and defense industries. 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 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. Each of the CIDO, the CISO and the EISG may call upon business and legal stakeholders across our company to manage cybersecurity threats and incidents.

The audit committee of our board of directors is responsible for oversight of the company's programs, policies, procedures, and risk management activities related to information security and data protection. The audit committee meets regularly with our CIDO and CISO to discuss threats, risks, and ongoing efforts to enhance cyber resiliency, as well as changes to the broader cybersecurity landscape. In addition, the ethics and compliance committee supports the audit committee and board in oversight of legal and regulatory compliance. Our board of directors also regularly participates in presentations on cybersecurity and information technology. In addition to regular presentations, management promptly updates our board of directors regarding significant threats and incidents as they arise.

Item 2.Properties

Our principal domestic and international executive offices are located in Indianapolis. At December 31, ~~2022,~~2023, we owned ~~nine~~eleven production, distribution, and corporate administrative sites in the United States (U.S.), including Puerto Rico. These facilities contain an aggregate of approximately ~~8.1~~9.0 million square feet of floor area dedicated to production, distribution, and administration. Major production sites include Indianapolis, Indiana; Carolina, Puerto Rico; Durham, North Carolina; and Branchburg, New Jersey. In 2023, we expect production to commence at an additional approximately 0.4 million square foot facility in Durham, North Carolina, with other production facilities and expansions of production facilities expected to come online in future periods.

We also own production and distribution sites in ~~seven countries outside the U.S.,~~Europe and Asia, containing an aggregate of approximately ~~4.6~~4.7 million square feet of floor area. Major production sites include facilities in Ireland, France, Spain, Italy, and China. Additional U.S. and international production facilities and expansions of production facilities are expected to come online in future periods.

In the U.S., our research and development facilities contain an aggregate of approximately ~~4.5~~4.9 million square feet of floor area, primarily consisting of owned facilities located in Indianapolis and smaller leased sites primarily in Boston, Massachusetts; San Diego, California; San Francisco, California; and New York, New York. Outside the U.S., we own a small research and development facility in Spain and lease a small site in Singapore.

We believe that none of our properties is subject to any encumbrance, easement, or other restriction that would detract materially from its value or impair its use in the operation of the business. The buildings we own are of varying ages and in good condition.

Item 3.Legal Proceedings

We are a party to various currently pending legal actions, government investigations, and environmental proceedings. Information pertaining to legal proceedings is described in Item 8, "Financial Statements and Supplementary Data - Note 16: Contingencies," and incorporated by reference herein.

Item 4.Mine Safety Disclosures

Not applicable.

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Part II

Item 5.Market for the Registrant's Common Equity, Related Stockholder Matters, and Issuer Purchases of Equity Securities

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

As of February ~~17, 2023,~~16, 2024, there were approximately ~~19,868~~18,871 holders of record of our common stock based on information provided by EQ Shareowner Services, our transfer agent. Our common stock is listed under the ticker symbol LLY on the New York Stock Exchange (NYSE).

The following table summarizes the activity related to repurchases of our equity securities during the fourth quarter ended December 31, ~~2022:~~2023:

Period Total Number of
Shares Purchased
(in thousands) Average Price Paid
per Share Total Number of Shares
Purchased as Part of
Publicly Announced
Plans or Programs
(in thousands) Approximate Dollar Value
of Shares that May Yet Be
Purchased Under the
Plans or Programs
(dollars in millions)
October 2022 — $ — — $ 3,250.0
November 2022 — — — 3,250.0
December 2022 — — — 3,250.0
Total — — —


Period	Total Number of Shares Purchased (in thousands)	Average Price Paid per Share		Total Number of Shares Purchased as Part of Publicly Announced Plans or Programs (in thousands)	Approximate Dollar Value of Shares that May Yet Be Purchased Under the Plans or Programs (dollars in millions)
October 2023	—	$	—	—	$	2,500.0
November 2023	—	—		—	2,500.0
December 2023	—	—		—	2,500.0
Total	—	—		—

During the three months ended December 31, ~~2022,~~2023, we did not repurchase any shares under our $5.00 billion share repurchase program authorized in May 2021.

3538

PERFORMANCE GRAPH

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 ~~2018~~2019 through ~~2022.~~2023. The graph assumes that, on the last business day of ~~2017,~~2018, a person invested $100 each in Lilly stock, the S&P 500 Stock Index, and the peer group's collective common stock. The graph measures total shareholder return, which takes into account both stock price and dividends. It assumes that dividends paid by a company are immediately reinvested in that company's stock.

Value of $100 Invested on Last Business Day of ~~2017~~2018 Comparison of Five-Year Cumulative Total Shareholder Return Among Lilly, S&P 500 Stock Index, and Peer Group(1)


			Lilly		Peer Group		S&P 500
Dec-17			$	100.00	$	100.00	$	100.00
		Lilly							Lilly	Peer Group	S&P 500
Dec-18	Dec-18		140.45		104.95		95.62
Dec-19	Dec-19		163.13		124.15		125.72
Dec-20	Dec-20		213.80		126.98		148.85
Dec-21	Dec-21		355.08		152.56		191.58
Dec-22	Dec-22		476.65		167.09		156.88
Dec-23


Title of Each Class	Trading Symbol(s)	Name of Each Exchange On Which Registered
Common Stock (no par value)	LLY	New York Stock Exchange
7 1/8% Notes due 2025	LLY25	New York Stock Exchange
1.625% Notes due 2026	LLY26	New York Stock Exchange
2.125% Notes due 2030	LLY30	New York Stock Exchange
0.625% Notes due 2031	LLY31	New York Stock Exchange
0.500% Notes due 2033	LLY33	New York Stock Exchange
6.77% Notes due 2036	LLY36	New York Stock Exchange
1.625% Notes due 2043	LLY43	New York Stock Exchange
1.700% Notes due 2049	LLY49A	New York Stock Exchange
1.125% Notes due 2051	LLY51	New York Stock Exchange
1.375% Notes due 2061	LLY61	New York Stock Exchange


Therapeutic area	Products	Certain Indications
Diabetes, Obesity and Other Cardiometabolic products	•Basaglar®~~, in collaboration with Boehringer Ingelheim, a long-acting human insulin analog for the treatment of diabetes.~~ •~~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.~~ •~~Humulin~~®, ~~Humulin 70/30, Humulin N, Humulin R,~~ ~~and~~ ~~Humulin U-500~~,~~human insulins of recombinant DNA origin for the treatment of diabetes.~~ •~~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; and to reduce the risk of cardiovascular death and hospitalizations for heart failure in adults. •~~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. •~~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. ~~Oncology products, including:~~ •~~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. •~~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 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 mutations. •~~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.®	In collaboration with Boehringer Ingelheim, a long-acting human insulin analog for the treatment of diabetes.
	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.
	Humulin®, Humulin 70/30, Humulin N, Humulin R, and Humulin U-500	Human insulins of recombinant DNA origin for the treatment of diabetes.
	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.
	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.
	Trulicity®	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.
	Zepbound®	For the treatment of adults with obesity or overweight with weight-related comorbidities as an adjunct to a reduced-calorie diet and increased physical activity (marketed under Mounjaro in the European Union (EU) and in various other markets outside the U.S.).


Therapeutic area	Products	Certain Indications
Oncology products	•~~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 that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options. •~~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; and for the first-line treatment of gastric cancer in combination with two other agents, each in China. •~~Verzenio~~®, for use as monotherapy or in combination with endocrine therapy for the treatment of HR+, HER2- metastatic breast cancer and in combination with endocrine therapy for treatment of HR+, HER2-, node positive, early breast cancer at high risk of recurrence and a Ki-67 score at least 20 percent, as determined by a U.S. Food and Drug Administration (FDA) approved test. ~~Immunology products, including:~~ •~~Olumiant~~®, in collaboration with Incyte Corporation, for the treatment of adults with moderately-to-severely active rheumatoid arthritis, moderate to severe atopic dermatitis, and severe alopecia areata, and for the treatment of hospitalized adults with COVID-19 who require supplemental oxygen, mechanical ventilation, or extracorporeal membrane oxygenation. •~~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. ~~Neuroscience products, including:~~ •~~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. •~~Emgality~~®~~, for migraine prevention and the treatment of episodic cluster headache in adults.~~ •~~Zyprexa~~®~~, for the treatment of schizophrenia, acute mixed or manic episodes associated with bipolar I disorder, and bipolar maintenance.~~ ~~Other products and therapies, including:~~ •~~Bamlanivimab~~ ~~and~~ ~~etesevimab, administered together, for the treatment of mild-to-moderate COVID-19~~ in adults and pediatric patients from birth to 12 years old with positive results of direct SARS-CoV-2 viral testing and who are at high risk for progression to severe COVID-19, including hospitalization or death (Emergency Use Authorization (EUA) granted in 2021). In May 2022, the FDA announced that bamlanivimab and etesevimab are not currently authorized for emergency use for any U.S. region. •~~Bebtelovimab~~, for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older and weighing at least 40 kilograms) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death, and for whom alternative COVID-19 treatment options approved or authorized by the FDA are not accessible or clinically appropriate (EUA granted in 2022). In November 2022, the FDA announced that bebtelovimab is not currently authorized for emergency use for any U.S. region. •~~Cialis~~®~~, for the treatment of erectile dysfunction and benign prostatic hyperplasia.~~ •~~Forteo~~®~~, for the treatment of osteoporosis in postmenopausal women and men at high risk for fracture and for glucocorticoid-induced osteoporosis in men and postmenopausal women.~~®	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.
	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 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 mutations.
	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.
	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.
	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.
	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 epidermal growth factor receptor (EGFR)-mutated non-squamous NSCLC that progressed after EGFR-tyrosine kinase inhibitor therapy, each in China.
	Verzenio®	For use as monotherapy or in combination with endocrine therapy for the treatment of HR+, HER2- metastatic breast cancer and in combination with endocrine therapy for treatment of HR+, HER2-, node positive, early breast cancer at high risk of recurrence.


Therapeutic area	Products	Certain Indications
Immunology products	Ebglyss®	For the treatment of adult and adolescent patients 12 years or older with moderate to severe atopic dermatitis in Japan and, in collaboration with Almirall S.A., in Europe.
	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.
	OmvohTM	For the treatment of adults with moderately to severely active ulcerative colitis.
	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.
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.
	Emgality®	For migraine prevention and the treatment of episodic cluster headache in adults.
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.


	Year Ended December 31						Percent Change
	2022			2021
Revenue	$	28,541.4		$	28,318.4		1
Gross margin	21,911.6			21,005.6			4
Gross margin as a percent of revenue	76.8		%	74.2		%

Research and development	$	7,190.8		$	6,930.7		4
Marketing, selling, and administrative	6,440.4			6,431.6			—
Acquired in-process research and development (IPR&D) and development milestones	908.5			970.1			(6)
Asset impairment, restructuring, and other special charges	244.6			316.1			(23)
Other—net, (income) expense	320.9			201.6			59




Net income	6,244.8			5,581.7			12


Earnings per share - diluted	6.90			6.12			13


	Year Ended December 31,				Percent Change
	2023		2022
Revenue	$	34,124.1	$	28,541.4	20
Net income	5,240.4		6,244.8		(16)
Earnings per share - diluted	5.80		6.90		(16)


~~Compound~~	~~Indication~~	~~Status~~	~~Developments~~
~~Diabetes~~

~~Empagliflozin (Jardiance~~®)~~(1)~~	~~Chronic kidney disease~~	~~Submitted~~	~~Granted FDA Fast Track designation(2). Submitted in the U.S. and Europe in January 2023.~~
~~Tirzepatide (Mounjaro~~®)	~~Obesity~~	~~Submission initiated~~	~~Granted FDA Fast Track designation(2)~~ ~~in 2022. Initiated a rolling submission in the U.S. in 2022. Phase III trials are ongoing.~~
	~~Heart failure with preserved ejection fraction~~	~~Phase III~~	~~Phase III trials are ongoing.~~
	~~Obstructive sleep apnea~~	~~Phase III~~	~~Phase III trial initiated in 2022. Granted FDA Fast Track designation(2)~~ ~~in 2022.~~
	~~Nonalcoholic steatohepatitis~~	~~Phase II~~	~~Phase II trial is ongoing.~~



~~Oncology~~
~~Abemaciclib (Verzenio~~®)	~~Prostate cancer~~	~~Phase III~~	~~Phase III trials are ongoing.~~


		2022 vs. 2021
		U.S.		Outside U.S.		Consolidated
	2023 vs. 2022														2023 vs. 2022
	U.S.											U.S.		Outside U.S.	Consolidated
Volume	Volume	11	%	9	%	10	%	Volume	11	%	25	%	16	%
Price	Price	(3)	%	(10)	%	(6)	%	Price	9	%	(4)	%	4	%
Foreign exchange rates	Foreign exchange rates	—	%	(8)	%	(3)	%	Foreign exchange rates	—	%	(1)	%	—	%
Percent change	Percent change	8	%	(10)	%	1	%	Percent change	20	%	19	%	20	%


(Dollars in millions)		2022		2021
						2023	2022
Sales return, rebate, and discount liabilities, beginning of year	Sales return, rebate, and discount liabilities, beginning of year	$	6,161.6	$	5,400.0
Reduction of net sales(1)	Reduction of net sales(1)	28,398.4		20,106.3
Cash payments	Cash payments	(26,345.9)		(19,344.7)
Sales return, rebate, and discount liabilities, end of year	Sales return, rebate, and discount liabilities, end of year	$	8,214.1	$	6,161.6


ELI LILLY AND COMPANY AND SUBSIDIARIES (Dollars in millions and shares in thousands, except per-share data)	Year Ended December 31	2022		2021		2020
Revenue (Note 2)		$	28,541.4	$	28,318.4	$	24,539.8
Costs, expenses, and other:
Cost of sales		6,629.8		7,312.8		5,483.3
Research and development		7,190.8		6,930.7		5,976.3
Marketing, selling, and administrative		6,440.4		6,431.6		6,121.2
Acquired in-process research and development and development milestones (Note 3)		908.5		970.1		769.8
Asset impairment, restructuring, and other special charges (Note 5)		244.6		316.1		131.2
Other—net, (income) expense (Note 18)		320.9		201.6		(1,171.9)
		21,735.0		22,162.9		17,309.9
Income before income taxes		6,806.4		6,155.5		7,229.9
Income taxes (Note 14)		561.6		573.8		1,036.2


Net income		$	6,244.8	$	5,581.7	$	6,193.7

Earnings per share:


Basic		$	6.93	$	6.15	$	6.82



Diluted		$	6.90	$	6.12	$	6.79

Shares used in calculation of earnings per share:
Basic		901,736		906,963		907,634
Diluted		904,619		911,681		912,505


ELI LILLY AND COMPANY AND SUBSIDIARIES (Dollars in millions, shares in thousands)	December 31	2022		2021
Assets
Current Assets
Cash and cash equivalents (Note 7)		$	2,067.0	$	3,818.5
Short-term investments (Note 7)		144.8		90.1
Accounts receivable, net of allowances of $16.0 (2022) and $22.5 (2021)		6,896.0		6,672.8
Other receivables		1,662.9		1,454.4
Inventories (Note 6)		4,309.7		3,886.0
Prepaid expenses and other current assets		2,954.1		2,530.6

Total current assets		18,034.5		18,452.4
Investments (Note 7)		2,901.8		3,212.6
Goodwill (Note 8)		4,073.0		3,892.0
Other intangibles, net (Note 8)		7,206.6		7,691.9
Deferred tax assets (Note 14)		2,792.9		2,489.3
Property and equipment, net (Note 9)		10,144.0		8,985.1

Other noncurrent assets		4,337.0		4,082.7

Total assets		$	49,489.8	$	48,806.0
Liabilities and Equity
Current Liabilities
Short-term borrowings and current maturities of long-term debt (Note 11)		$	1,501.1	$	1,538.3
Accounts payable		1,930.6		1,670.6
Employee compensation		1,059.8		958.1
Sales rebates and discounts		8,784.1		6,845.8
Dividends payable		1,017.2		885.5
Income taxes payable (Note 14)		475.1		126.9
Other current liabilities		2,370.3		3,027.5

Total current liabilities		17,138.2		15,052.7
Other Liabilities
Long-term debt (Note 11)		14,737.5		15,346.4
Accrued retirement benefits (Note 15)		1,305.1		1,954.1
Long-term income taxes payable (Note 14)		3,709.6		3,920.0
Deferred tax liabilities (Note 14)		87.3		1,733.7
Other noncurrent liabilities		1,736.7		1,644.3

Total other liabilities		21,576.2		24,598.5
Commitments and Contingencies (Note 16)
Eli Lilly and Company Shareholders' Equity (Notes 12 and 13)
Common stock—no par value Authorized shares: 3,200,000 Issued shares: 950,632 (2022) and 954,116 (2021)		594.1		596.3
Additional paid-in capital		6,921.4		6,833.4
Retained earnings		10,042.6		8,958.5
Employee benefit trust		(3,013.2)		(3,013.2)
Accumulated other comprehensive loss (Note 17)		(3,844.6)		(4,343.1)
Cost of common stock in treasury		(50.5)		(52.7)
Total Eli Lilly and Company shareholders' equity		10,649.8		8,979.2
Noncontrolling interests		125.6		175.6
Total equity		10,775.4		9,154.8
Total liabilities and equity		$	49,489.8	$	48,806.0


	Equity of Eli Lilly and Company Shareholders
ELI LILLY AND COMPANY AND SUBSIDIARIES (Dollars in millions, except per-share data, and shares in thousands)	Common Stock			Additional Paid-in Capital		Retained Earnings		Employee Benefit Trust		Accumulated Other Comprehensive Loss		Common Stock in Treasury			Noncontrolling Interest
	Shares	Amount										Shares	Amount
Balance at January 1, 2020	958,056	$	598.8	$	6,685.3	$	4,920.4	$	(3,013.2)	$	(6,523.6)	530	$	(60.8)	$	92.2
Net income						6,193.7									126.6
Other comprehensive income, net of tax										27.2
Cash dividends declared per share: $3.07						(2,786.2)
Retirement of treasury shares	(3,627)	(2.3)				(497.7)						(3,627)	500.0
Purchase of treasury shares												3,627	(500.0)
Issuance of stock under employee stock plans, net	2,648	1.7		(212.7)								(43)	5.1
Stock-based compensation				308.1


Other				(2.2)											(35.2)
Balance at December 31, 2020	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
Other comprehensive income, net of tax										2,153.3
Cash dividends declared per share: $3.53						(3,201.7)
Retirement of treasury shares	(5,412)	(3.4)				(1,246.6)						(5,412)	1,250.0
Purchase of treasury shares												5,412	(1,250.0)
Issuance of stock under employee stock plans, net	2,451	1.5		(287.9)								(24)	3.0
Stock-based compensation				342.8


Other						(5.1)									(11.4)
Balance at December 31, 2021	954,116	596.3		6,833.4		8,958.5		(3,013.2)		(4,343.1)		463	(52.7)		175.6
Net income (loss)						6,244.8									(20.9)
Other comprehensive income, net of tax										498.5
Cash dividends declared per share: $4.07						(3,667.5)
Retirement of treasury shares	(5,607)	(3.5)				(1,496.5)						(5,607)	1,500.0
Purchase of treasury shares												5,607	(1,500.0)
Issuance of stock under employee stock plans, net	2,123	1.3		(283.1)								(13)	2.2
Stock-based compensation				371.1


Other						3.3									(29.1)
Balance at December 31, 2022	950,632	$	594.1	$	6,921.4	$	10,042.6	$	(3,013.2)	$	(3,844.6)	450	$	(50.5)	$	125.6


Estimated Fair Value at December 27, 2023
Cash	$	302.7
Acquired IPR&D	196.0
Goodwill(1)	859.1

Other assets and liabilities, net	(19.3)
Acquisition date fair value of consideration transferred	1,338.5
Less:
Cash acquired	(302.7)
Cash paid, net of cash acquired	$	1,035.8


Estimated Fair Value at December 1, 2022
Cash	$	153.2
Acquired IPR&D(1)	184.0
Goodwill(2)	~~181.2~~185.6

Other assets and liabilities, net	~~28.9~~24.5
Acquisition date fair value of consideration transferred	547.3
Less:
Cash acquired	(153.2)
Fair value of CVR liability(3)	(66.9)
Cash paid, net of cash acquired	$	327.2


Estimated Fair Value at January 22, 2021
Cash	$	90.5
Acquired IPR&D(1)	824.0
Goodwill(2)	126.8
Deferred tax liabilities	(106.0)
Other assets and liabilities, net	(31.5)
Acquisition date fair value of consideration transferred	903.8
Less:
Cash acquired	(90.5)
Fair value of CVR liability(3)	(65.9)
Cash paid, net of cash acquired	$	747.4


	Year Ended December 31,

		Year Ended December 31,
		2022						2021		Percent Change	2023									2022					Percent Change
Product	Product	U.S.		Outside U.S.		Total		Total			Product	U.S.			Outside U.S.				Total									Total				Percent Change
Trulicity	Trulicity	$	5,688.8	$	1,750.9	$	7,439.7	$	6,471.9	15	Trulicity	$	5,433.3	$	$	1,699.2	$		$	7,132.6				$		$								(4)
Mounjaro											Mounjaro	4,834.2			328.9				5,163.1					482.5						NM
Verzenio	Verzenio	1,653.2		830.3		2,483.5		1,349.9		84	Verzenio	2,509.0		1,354.3		1,354.3		3,863.4			3,863.4		2,483.5				2,483.5		56				56
Taltz	Taltz	1,724.6		757.4		2,482.0		2,212.8		12	Taltz	1,831.6		928.0		928.0		2,759.6			2,759.6		2,482.0				2,482.0		11				11
Jardiance(1)	Jardiance(1)	1,194.5		871.5		2,066.0		1,490.8		39	Jardiance(1)	1,600.4		1,144.2		1,144.2		2,744.7			2,744.7		2,066.0				2,066.0		33				33
Humalog(2)		1,191.9		868.7		2,060.6		2,453.0		(16)
COVID-19 antibodies(3)		2,008.9		14.7		2,023.5		2,239.3		(10)
Zyprexa(2)											Zyprexa(2)	79.4			1,615.4				1,694.8					336.9						NM
Humalog(3)											Humalog(3)	863.2			800.2				1,663.3					2,060.6						(19)
Cyramza®											Cyramza®	402.3			572.4				974.7					971.4						—
Olumiant® (4)											Olumiant® (4)	225.5			697.2				922.6					830.5						11
Humulin®	Humulin®	730.2		289.2		1,019.4		1,222.6		(17)	Humulin®	610.1		242.0		242.0		852.1			852.1		1,019.4				1,019.4		(16)				(16)
Cyramza®		351.4		620.0		971.4		1,033.0		(6)
Alimta		543.7		384.0		927.7		2,061.4		(55)
Olumiant®(4)		148.2		682.3		830.5		1,115.1		(26)
Basaglar		470.7		289.7		760.4		892.5		(15)
Basaglar® (5)											Basaglar® (5)	443.1			285.2				728.3					760.4						(4)
Emgality®	Emgality®	462.8		188.1		650.9		577.2		13	Emgality®	482.2		196.0		196.0		678.3			678.3		650.9				650.9		4				4
Baqsimi											Baqsimi	645.7			31.9				677.6					139.3						NM
Erbitux®											Erbitux®	528.9			67.6				596.5					566.5						5
Forteo®	Forteo®	367.3		245.8		613.1		801.9		(24)	Forteo®	335.5		197.7		197.7		533.2			533.2		613.1				613.1		(13)				(13)
Cialis®	Cialis®	35.2		552.1		587.3		718.4		(18)	Cialis®	26.1		355.3		355.3		381.5			381.5		587.3				587.3		(35)				(35)
Erbitux®		500.1		66.4		566.5		548.3		3
Mounjaro		366.6		115.9		482.5		—		NM
Zyprexa®		30.4		306.5		336.9		430.3		(22)
Tyvyt		—		293.3		293.3		418.1		(30)
Cymbalta		33.7		249.6		283.3		581.5		(51)
Alimta											Alimta	72.9			144.6				217.5					927.7						(77)
Zepbound											Zepbound	175.8			—				175.8					—						NM
COVID-19 antibodies(6)											COVID-19 antibodies(6)	—			—				—					2,023.5						NM
Other products	Other products	687.8		974.9		1,662.9		1,700.4		(2)	Other products	691.8		1,673.0		1,673.0		2,364.5			2,364.5		2,100.2				2,100.2		13				13
Revenue	Revenue	$	18,190.0	$	10,351.3	$	28,541.4	$	28,318.4	1	Revenue	$	21,791.0	$	$	12,333.1	$		$	34,124.1		$		$	28,541.4			20			20


	Net Milestones Capitalized (Deferred)(1)
	2022		2021
Jardiance	$	116.2	$	136.1
Trajenta	63.5		88.5
Basaglar	(130.6)		(149.3)


	Maturities by Period
	Total		Less Than 1 Year		1-5 Years		6-10 Years		More Than 10 Years
Fair value of debt securities	$	646.3	$	86.2	$	242.0	$	104.0	$	214.1


						Fair Value Measurements Using										Fair Value Measurements Using
		Carrying Amount		Cost (1)		Quoted Prices in Active Markets for Identical Assets (Level 1)		Significant Other Observable Inputs (Level 2)		Significant Unobservable Inputs (Level 3)		Fair Value
December 31, 2022
	Carrying Amount													Carrying Amount	Cost (1)		Quoted Prices in Active Markets for Identical Assets (Level 1)	Significant Other Observable Inputs (Level 2)	Significant Unobservable Inputs (Level 3)	Fair Value
December 31, 2023
Cash equivalents(2)
Cash equivalents(2)
Cash equivalents(2)	Cash equivalents(2)	$	657.4	$	657.4	$	650.4	$	7.0	$	—	$	657.4
Short-term investments:	Short-term investments:
U.S. government and agency securities	U.S. government and agency securities	$	30.8	$	31.1	$	30.8	$	—	$	—	$	30.8
U.S. government and agency securities
U.S. government and agency securities
Corporate debt securities	Corporate debt securities	53.4		53.5		—		53.4		—		53.4

Asset-backed securities		2.0		2.0		—		2.0		—		2.0

Other securities

Other securities

Other securities	Other securities	58.6		58.6		—		39.1		19.5		58.6

Short-term investments	Short-term investments	$	144.8
Short-term investments
Short-term investments
Noncurrent investments:
Noncurrent investments:
Noncurrent investments:
U.S. government and agency securities	U.S. government and agency securities	$	146.4	$	163.2	$	146.4	$	—	$	—	$	146.4
Corporate debt securities	Corporate debt securities	213.9		235.8		—		213.9		—		213.9
Mortgage-backed securities	Mortgage-backed securities	149.2		161.5		—		149.2		—		149.2
Asset-backed securities	Asset-backed securities	50.6		52.5		—		50.6		—		50.6
Other securities	Other securities	398.6		34.5		—		311.0		87.6		398.6
Marketable equity securities	Marketable equity securities	683.6		484.7		683.6		—		—		683.6
Equity investments without readily determinable fair values(3)	Equity investments without readily determinable fair values(3)	478.4
Equity method investments(3)	Equity method investments(3)	781.1
Equity method investments(3)
Equity method investments(3)
Noncurrent investments
Noncurrent investments
Noncurrent investments	Noncurrent investments	$	2,901.8

December 31, 2021
December 31, 2022

December 31, 2022

December 31, 2022
Cash equivalents(2)
Cash equivalents(2)
Cash equivalents(2)	Cash equivalents(2)	$	2,379.5	$	2,379.5	$	2,361.0	$	18.5	$	—	$	2,379.5
Short-term investments:	Short-term investments:
U.S. government and agency securities	U.S. government and agency securities	$	25.7	$	25.6	$	25.7	$	—	$	—	$	25.7
U.S. government and agency securities
U.S. government and agency securities
Corporate debt securities	Corporate debt securities	43.7		43.7		—		43.7		—		43.7
Mortgage-backed securities		0.2		0.2		—		0.2		—		0.2

Asset-backed securities
Asset-backed securities
Asset-backed securities	Asset-backed securities	6.2		6.2		—		6.2		—		6.2
Other securities	Other securities	14.3		14.3		—		—		14.3		14.3

Short-term investments	Short-term investments	$	90.1
Short-term investments
Short-term investments
Noncurrent investments:	Noncurrent investments:
Noncurrent investments:
Noncurrent investments:
U.S. government and agency securities
U.S. government and agency securities
U.S. government and agency securities	U.S. government and agency securities	$	137.0	$	136.8	$	137.0	$	—	$	—	$	137.0
Corporate debt securities	Corporate debt securities	235.3		232.7		—		235.3		—		235.3
Mortgage-backed securities	Mortgage-backed securities	109.8		108.1		—		109.8		—		109.8
Asset-backed securities	Asset-backed securities	23.1		23.1		—		23.1		—		23.1
Other securities	Other securities	108.1		22.2		—		—		108.1		108.1
Marketable equity securities	Marketable equity securities	1,279.7		487.0		1,279.7		—		—		1,279.7
Equity investments without readily determinable fair values(3)	Equity investments without readily determinable fair values(3)	548.1
Equity method investments(3)	Equity method investments(3)	771.5
Equity method investments(3)
Equity method investments(3)
Noncurrent investments	Noncurrent investments	$	3,212.6
Noncurrent investments
Noncurrent investments


	2024		2025		2026		2027		2028
Estimated amortization expense	$	542.5	$	530.3	$	519.7	$	517.7	$	511.6


2023		$	154.2
2024
2024
2024	2024	131.4
2025	2025	115.1
2026	2026	96.1
2027	2027	76.3
After 2027		250.3
2028
After 2028
Total lease payments	Total lease payments	823.4
Less imputed interest	Less imputed interest	95.2
Total	Total	$	728.2


	Total		Less than 1 Year		1-3 Years
2017 Tax Act Toll Tax	$	1,895.8	$	475.7	$	1,420.1


	Defined Benefit Pension Plans				Retiree Health Benefit Plans
	2022		2021		2022		2021
Change in benefit obligation:
Benefit obligation at beginning of year	$	17,565.0	$	18,225.5	$	1,663.8	$	1,753.7
Service cost	351.7		369.2		46.6		49.2
Interest cost	398.1		337.8		37.8		32.5
Actuarial (gain) loss	(4,158.9)		(564.3)		(395.9)		(86.1)
Benefits paid	(608.9)		(630.1)		(86.8)		(79.3)


Foreign currency exchange rate changes and other adjustments	(325.0)		(173.1)		(6.7)		(6.2)
Benefit obligation at end of year	13,222.0		17,565.0		1,258.8		1,663.8


Change in plan assets:
Fair value of plan assets at beginning of year	16,416.0	14,579.0	3,361.4	3,227.0
Actual return on plan assets	(2,388.1)	2,458.1	(796.0)	202.6
Employer contribution	118.1	131.2	13.9	11.1
Benefits paid	(608.9)	(630.1)	(86.8)	(79.3)
Foreign currency exchange rate changes and other adjustments	(341.3)	(122.2)	—	—
Fair value of plan assets at end of year	13,195.8	16,416.0	2,492.5	3,361.4


Funded status	(26.2)		(1,149.0)		1,233.7		1,697.6
Unrecognized net actuarial (gain) loss	2,687.2		3,908.2		54.5		(497.2)
Unrecognized prior service (benefit) cost	8.4		11.2		(62.2)		(117.6)
Net amount recognized	$	2,669.4	$	2,770.4	$	1,226.0	$	1,082.8


	Defined Benefit Pension Plans						Retiree Health Benefit Plans
(Percents)	2022		2021		2020		2022		2021		2020
Discount rate for benefit obligation	5.1	%	2.8	%	2.4	%	5.2	%	3.0	%	2.6	%
Discount rate for net benefit costs	2.8		2.4		3.0		3.0		2.6		3.3
Rate of compensation increase for benefit obligation	4.3		3.5		3.3
Rate of compensation increase for net benefit costs	3.5		3.3		3.3
Expected return on plan assets for net benefit costs	8.1		6.8		7.3		7.3		5.0		6.0


			Fair Value Measurements Using
Asset Class	Total		Quoted Prices in Active Markets for Identical Assets (Level 1)		Significant Observable Inputs (Level 2)		Significant Unobservable Inputs (Level 3)		Investments Valued at Net Asset Value(1)
Defined Benefit Pension Plans
Public equity securities:
U.S.	$	1,379.7	$	490.5	$	0.3	$	—	$	888.9
International	1,408.9		441.2		333.4		—		634.3
Fixed income:
Developed markets	2,783.9		21.2		2,597.3		0.1		165.3
Developed markets - repurchase agreements	(772.8)		13.2		(786.0)		—		—
Emerging markets	295.6		10.4		35.7		—		249.5
Private alternative investments:
Hedge funds	3,125.9		—		—		—		3,125.9
Equity-like funds	4,093.7		—		—		25.1		4,068.6
Real estate	369.7		261.9		—		—		107.8
Other	1,024.1		170.8		42.6		—		810.7
Total	$	13,708.7	$	1,409.2	$	2,223.3	$	25.2	$	10,051.0

Retiree Health Benefit Plans
Public equity securities:
U.S.	$	127.0	$	44.2	$	—	$	—	$	82.8
International	89.9		38.2		—		—		51.7
Fixed income:
Developed markets	74.9		—		74.9		—		—
Emerging markets	23.4		—		—		—		23.4
Private alternative investments:
Hedge funds	281.2		—		—		—		281.2
Equity-like funds	335.1		—		—		2.4		332.7
Cash value of trust owned insurance contract	1,526.5		—		1,526.5		—		—
Real estate	24.5		24.5		—		—		—
Other	97.8		23.2		2.1		—		72.5
Total	$	2,580.3	$	130.1	$	1,603.5	$	2.4	$	844.3


(Amounts presented net of taxes)	(Amounts presented net of taxes)	Foreign Currency Translation Gains (Losses)		Unrealized Net Gains (Losses) on Securities		Defined Benefit Pension and Retiree Health Benefit Plans		Effective Portion of Cash Flow Hedges		Accumulated Other Comprehensive Loss
Beginning balance at January 1, 2020		$	(1,678.0)	$	4.9	$	(4,638.6)	$	(211.9)	$	(6,523.6)

(Amounts presented net of taxes)

(Amounts presented net of taxes)												Foreign Currency Translation Gains (Losses)	Net Unrealized Gains (Losses) on Available-For-Sale Securities	Retirement Benefit Plans	Net Unrealized Gains (Losses) on Cash Flow Hedges	Accumulated Other Comprehensive Loss
Beginning balance at January 1, 2021

Other comprehensive income (loss) before reclassifications
Other comprehensive income (loss) before reclassifications
Other comprehensive income (loss) before reclassifications	Other comprehensive income (loss) before reclassifications	250.5		6.8		(379.7)		(133.8)		(256.2)
Net amount reclassified from accumulated other comprehensive loss	Net amount reclassified from accumulated other comprehensive loss	—		3.1		267.3		13.0		283.4
Net other comprehensive income (loss)	Net other comprehensive income (loss)	250.5		9.9		(112.4)		(120.8)		27.2

Balance at December 31, 2020		(1,427.5)		14.8		(4,751.0)		(332.7)		(6,496.4)
Balance at December 31, 2021

Balance at December 31, 2021

Balance at December 31, 2021

Other comprehensive income (loss) before reclassifications

Other comprehensive income (loss) before reclassifications

Other comprehensive income (loss) before reclassifications	Other comprehensive income (loss) before reclassifications	(122.7)		(11.9)		1,823.4		106.6		1,795.4
Net amount reclassified from accumulated other comprehensive loss	Net amount reclassified from accumulated other comprehensive loss	—		0.8		344.0		13.1		357.9
Net other comprehensive income (loss)	Net other comprehensive income (loss)	(122.7)		(11.1)		2,167.4		119.7		2,153.3

Balance at December 31, 2021		(1,550.2)		3.7		(2,583.6)		(213.0)		(4,343.1)
Balance at December 31, 2022
Balance at December 31, 2022
Balance at December 31, 2022

Other comprehensive income (loss) before reclassifications
Other comprehensive income (loss) before reclassifications
Other comprehensive income (loss) before reclassifications	Other comprehensive income (loss) before reclassifications	(324.4)		(52.2)		291.5		332.8		247.7
Net amount reclassified from accumulated other comprehensive loss	Net amount reclassified from accumulated other comprehensive loss	0.4		11.4		229.8		9.2		250.8
Net other comprehensive income (loss)	Net other comprehensive income (loss)	(324.0)		(40.8)		521.3		342.0		498.5

Ending balance at December 31, 2022		$	(1,874.2)	$	(37.1)	$	(2,062.3)	$	129.0	$	(3,844.6)
Ending balance at December 31, 2023
Ending balance at December 31, 2023
Ending balance at December 31, 2023


Tax benefit (expense)	2022		2021		2020
Foreign currency translation gains/losses	$	(75.9)	$	(136.2)	$	128.3
Unrealized net gains/losses on securities	12.4		4.7		(4.3)
Defined benefit pension and retiree health benefit plans	(95.6)		(532.0)		44.8
Effective portion of cash flow hedges	(90.9)		(31.8)		32.1
Benefit/(provision) for income taxes allocated to other comprehensive income (loss) items	$	(250.0)	$	(695.3)	$	200.9


Details about Accumulated Other Comprehensive Loss Components		Year Ended December 31,						Affected Line Item in the Consolidated Statements of Operations
		2022		2021		2020
	Year Ended December 31,																				Year Ended December 31,							Affected Line Item in the Consolidated Statements of Operations
									2023					2022							2021
Amortization of retirement benefit items:	Amortization of retirement benefit items:
Prior service benefits, net
Prior service benefits, net
Prior service benefits, net	Prior service benefits, net	$	(52.4)	$	(55.4)	$	(55.0)	Other—net, (income) expense	$	(50.5)		$		$	(52.4)			$		$	(55.4)		Other—net, (income) expense	Other—net, (income) expense
Actuarial losses	Actuarial losses	343.3		490.9		393.3		Other—net, (income) expense	Actuarial losses		116.2		343.3				343.3		490.9					490.9		Other—net, (income) expense	Other—net, (income) expense
Total before tax	Total before tax	290.9		435.5		338.3
Tax benefit	Tax benefit	(61.1)		(91.5)		(71.0)		Income taxes
Tax benefit
Tax benefit											(13.8)					(61.1)						(91.5)			Income taxes
Net of tax	Net of tax	229.8		344.0		267.3

Other, net of tax	Other, net of tax	21.0		13.9		16.1		Other—net, (income) expense

Other, net of tax

Other, net of tax											(16.1)					21.0						13.9			Other—net, (income) expense
Total reclassifications for the period, net of tax	Total reclassifications for the period, net of tax	$	250.8	$	357.9	$	283.4


						Medicaid, Managed Care, and Medicare sales rebate accruals
Description of the Matter						As described in Note 2 to the consolidated financial statements under the caption "Net Product Revenue," the Company establishes provisions for sales rebate and discounts in the same period as the related sales occur. At December 31, ~~2022~~2023, the Company had ~~$8,784.1~~$11,689.0 million in sales rebate and discount accruals. A large portion of these accruals are rebates associated with sales in the United States for which payment for purchase of the product is covered by Medicaid, Managed Care, and Medicare. Auditing the Medicaid, Managed Care, and Medicare sales rebate and discount liabilities is challenging because of the subjectivity of certain assumptions required to estimate the rebate liabilities. In calculating the appropriate accrual amount, the Company considers historical Medicaid, Managed Care, and Medicare rebate payments by product as a percentage of their historical sales as well as any significant changes in sales trends, the lag in payment timing, changes in rebate contracts, an evaluation of the current Medicaid and Medicare laws and interpretations, the percentage of products that are sold via Medicaid, Managed Care, and Medicare, and product pricing. For Medicaid, there is significant complexity associated with calculating the legislated Medicaid rebates. Management utilizes employees with legislative experience and knowledge in developing assumptions used to calculate Medicaid rebates. Similarly, for Managed Care and Medicare, givenGiven variability in prescription drug costs, continued historical year over year increases in enrollees and variability in prescription data, historical rebate information may not be predictive for management to estimate the rebate accrual and thus, management supplements its historical data analysis with qualitative adjustments based upon current ~~utilization.~~expectations, particularly for select products which contribute the largest portion of the Company's revenue.
How We Addressed the Matter in Our Audit						We tested the Company's controls addressing the identified risks of material misstatement related to the valuation of the sales rebate and discount liabilities. This included testing controls over management's review of the significant assumptions used to calculate the Medicaid, Managed Care, and Medicare rebate liabilities, including the significant assumptions discussed above. This testing also included management's control to compare actual activity to forecasted activity and controls to ensure the data used to evaluate the significant assumptions was complete and accurate. Our audit procedures included, among others, evaluating for reasonableness the significant assumptions in light of economic trends, product profiles, and other regulatory factors. Our testing involved assessing the historical accuracy of management's estimates by comparing actual activity to previous estimates and performing analytical procedures, based on internal and external data sources, to evaluate the completeness of the reserves. Additionally, our procedures included reviewing a sample of contracts, testing a sample of rebate payments and testing the underlying data used in management's evaluation. For Medicaid, we involved our professionals with an understanding of the statutory reimbursement requirements to assess the consistency of the Company's calculation methodologies with the applicable government regulations and policy.~~For Medicare we evaluated the reasonableness of assumptions made by management in estimating the Medicare coverage gap liability.~~


						Retirement Benefits - Valuation of Alternative Investments
Description of the Matter						As described in Note 15 to the consolidated financial statements under the caption "Benefit Plan Investments," the Company's benefit plan investment policies are set with specific consideration of return and risk requirements in relationship to the respective liabilities. At December 31, ~~2022~~2023, the Company had ~~$15,688.3~~$16,289.0 million in plan assets related to the defined benefit pension plans and retiree health benefit plans. Approximately 5048 percent of the total pension and retiree health assets are in hedge funds and private equity-like investment funds ("alternative investments"). These alternative investments are valued ~~using significant unobservable inputs or are valued~~primarily at net asset value (NAV) reported by the counterparty, adjusted as necessary. Auditing the fair value of these alternative investments is challenging because of the higher estimation uncertainty of the inputs to the fair value calculations, ~~including~~particularly the underlying determination of net asset values ("NAVs")~~, discounted cash flow valuations, comparable market valuations, and adjustments for currency, credit, liquidity and other risks.~~. Additionally, certain information regarding the fair value of these alternative investments is based on unaudited information available to management at the time of valuation.
How We Addressed the Matter in Our Audit						We tested the Company's controls addressing the risks of material misstatement relating to valuation of alternative investments. This included testing management's ~~review~~ controls over alternative investment valuation, which included a comparison of returns to benchmarks and monitoring of investment firms' valuation policies and procedures, as well as portfolio performance. Our audit procedures included, among others, comparing fund returns to selected relevant benchmarks and understanding variations, and obtaining the latest audited financial statements and comparing to the Company's estimated fair values. We also inquired of management about changes to the investment portfolio and/or related investment strategies and considerations. We assessed the historical accuracy of management's estimates by comparing actual activity to previous estimates. We evaluated for contrary evidence by confirming the fair value of the investments and ownership interest directly with the ~~trustees~~custodian and a sample of fund managers at year end.


Plan category	(a) Number of securities to be issued upon exercise of outstanding options, warrants, and rights (1)	(b) Weighted-average exercise price of outstanding options, warrants, and rights		(c) Number of securities remaining available for future issuance under equity compensation plans (excluding securities reflected in column (a))
Equity compensation plans approved by security holders	—	$	—	~~49,953,648~~49,082,012
Equity compensation plan not approved by security holders	—	—		—
Total	—	—		~~49,953,648~~49,082,012


Exhibit						Description

3.1						Amended Articles of Incorporation, incorporated by reference to Exhibit 3.1 to the Company's Current Report on Form 8-K filed on May 4, 2022

3.2						Bylaws, as amended, incorporated by reference to Exhibit 3.2 to the Company's Current Report on Form 8-K filed on May 4, 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. 333-186979

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, 2008

4.3						Description of the Company's Common ~~Stock, incorporated by reference to Exhibit 4.3 to the Company's Annual Report on Form 10-K for the year ended December 31, 2019~~Stock*

4.4						Description of the Company's 1.625% Notes due 2026 and 2.125% Notes due 2030, incorporated by reference to Exhibit 4.4 to the Company's Annual Report on Form 10-K for the year ended December 31, 2019

4.5						Description of the Company's 6.77% Notes due 2036, incorporated by reference to Exhibit 4.5 to the Company's Annual Report on Form 10-K for the year ended December 31, 2019

4.6						Description of the Company's 7 1/8% Notes due 2025, incorporated by reference to Exhibit 4.6 to the Company's Annual Report on Form 10-K for the year ended December 31, 2019

4.7						Description of the Company's 0.625% Notes due 2031 and 1.700% Notes due 2049, incorporated by reference to Exhibit 4.7 to the Company's Annual Report on Form 10-K for the year ended December 31, 2019


4.8						Description of the Company's 0.500% Notes due 2033, 1.125% Notes due 2051, and 1.375% Notes due 2061, incorporated by reference to Exhibit 4.8 to the Company's Annual Report on Form 10-K for the year ended December 31, 2021

4.9						Description of the Company's 1.625% Notes due 2043, incorporated by reference to Exhibit 4.9 to the Company's Annual Report on Form 10-K for the year ended December 31, 2021

10.1						Amended and Restated 2002 Lilly Stock 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, 2018

10.2						Form of Performance Award under the 2002 Lilly Stock Plan(1)* incorporated by reference to Exhibit 10.2 to the Company's Annual Report on Form 10-K for the year ended December 31, 2022

10.3						Form of Shareholder Value Award under the 2002 Lilly Stock Plan(1)*

10.4						Form of Relative Value Award under the 2002 Lilly Stock Plan(1)*

10.5						Form of Restricted Stock Unit Award under the 2002 Lilly Stock Plan(1)*

10.6						Form of Non-Compete Payment Agreement(1)*, incorporated by reference to Exhibit 10.5 to the Company's Annual Report on Form 10-K for the year ended December 31, 2022

~~10.6~~10.7						The Lilly Deferred Compensation Plan, as amended(1), incorporated by reference to Exhibit 10.5 to the Company's ~~annual report~~Annual Report on Form 10-K for the year ended December 31, 2013

~~10.7~~10.8						The Lilly Directors' Deferral Plan, as amended(1), incorporated by reference to Exhibit 10 to the Company's Quarterly Report on Form 10-Q for the quarter ended June 30, 2017

~~10.8~~10.9						The Eli Lilly and Company Bonus Plan, as amended(1), incorporated by reference to Exhibit 10.14 to the Company's Annual Report on Form 10-K for the year ended December 31, 2020

~~10.9~~						~~The Loxo Oncology, Inc. Bonus Plan(1), incorporated by reference to Exhibit 10.17 to the Company's Annual Report on Form 10-K for the year ended December 31, 2021~~

10.10						2007 Change in Control Severance Pay Plan for Select Employees, as amended(1)~~, incorporated by reference to Exhibit 10.15 to the Company's Annual Report on Form 10-K for the year ended December 31, 2020~~*

21						List of Subsidiaries*

23						Consent of Independent Registered Public Accounting Firm*

31.1						Rule 13a-14(a) Certification of David Ricks, Chair, President, and Chief Executive Officer*

31.2						Rule 13a-14(a) Certification of Anat Ashkenazi, Executive Vice President and Chief Financial Officer*

32						Section 1350 Certification*

97						Executive Compensation Recovery Policy*

101						Interactive Data File*

104						Cover Page Interactive Data File (formatted in Inline XBRL and contained in Exhibit 101)*


By						/s/ David Ricks
David Ricks
Chair, President, and Chief Executive Officer