Risk Sleuth
LLY · 10-K filed 12 Feb 2026 · year to 31 Dec 2025

Eli Lilly

29 named things its latest annual report says its results depend on, each in the company's own words. 20 of them are also named by other companies we've read.

Customers

McKesson Corporation

earns fromnamed as a risk
In 2025, 2024, and 2023, three wholesale distributors in the U.S.—McKesson Corporation, Cencora, Inc., and Cardinal Health, Inc.—each accounted for a significant percentage of our consolidated revenue.Business (Item 1)

Also named by ABBV, AMGN, CAH, COR, GILD, HALO, HROW, HSIC and 1 more

Cardinal Health, Inc.

earns fromnamed as a risk
In 2025, 2024, and 2023, three wholesale distributors in the U.S.—McKesson Corporation, Cencora, Inc., and Cardinal Health, Inc.—each accounted for a significant percentage of our consolidated revenue.Business (Item 1)

Also named by ABBV, AMGN, BAX, COR, CVS, GILD, HROW, MCK and 1 more

Cencora, Inc.

earns fromnamed as a risk
In 2025, 2024, and 2023, three wholesale distributors in the U.S.—McKesson Corporation, Cencora, Inc., and Cardinal Health, Inc.—each accounted for a significant percentage of our consolidated revenue.Business (Item 1)

Also named by ABBV, AMGN, CAH, GILD, HROW, MCK

CVS Caremark

earns fromnamed as a risk
For example, in July 2025, CVS Caremark, the pharmacy benefit management division of CVS Health, stopped covering Zepbound as a preferred obesity management medicine on some insurance plans, which has negatively impacted access for patients covered under these plans.Risk factors (Item 1A)

Also named by MOH, OSCR

Partners and platforms

Boehringer Ingelheim

depends onnamed as a risk
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.Business (Item 1)

LillyDirect

earns fromnamed as a risk
In addition, patient self-pay sales through LillyDirect represented a growing portion of our business in 2025, and we have launched, and continue to explore, new partnerships and tools, including through LillyDirect, to further expand access to our medicines.Risk factors (Item 1A)

Incyte Corporation

depends on
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.Business (Item 1)

Innovent Biologics, Inc.

depends on
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 EGFR-mutated non-squamous NSCLC that progressed after EGFR-tyrosine kinase inhibitor therapy, each in China.Business (Item 1)

Other companies

Mounjaro and Zepbound (tirzepatide)

concentrated in · 56 percent of our total revenues in 2025named as a risk
In particular, Mounjaro and Zepbound accounted for 56 percent of our total revenues in 2025, and we expect cardiometabolic health products will continue to represent a significant and growing portion of our business, revenues, and prospects.Risk factors (Item 1A)

Trulicity

concentrated innamed as a risk
For example, Trulicity will lose significant patent and remaining data protections in the next few years.Risk factors (Item 1A)

Competitors

Compounded incretins

competes withnamed as a risk
If inadequately regulated, these practices could materially impact our business and reputation, including by creating consumer confusion or misperceptions about the safety and efficacy of our genuine products, diversion of potential sales and potential net price erosion for our products.Business (Item 1)

Places

China

depends onnamed as a risk
For example, we, and the pharmaceutical industry generally, depend on China-based suppliers for portions of our supply chain, including integral chemical synthesis, reagents, starting materials, and ingredients.Risk factors (Item 1A)

Also named by A, AA, AAOI, AAP, AAPL, AB, ADI, AEHR and 261 more

Japan

subject tonamed as a risk
In Japan, our products can be subject to government-mandated annual price reductions.Business (Item 1)

Also named by A, AAPL, AFL, AMKR, ANET, BMY, BSX, CAT and 25 more

Ireland

operates in
Our active ingredient manufacturing and finishing operations, including formulation, filling, assembling, delivery device manufacturing, and packaging, take place at sites in the U.S., including Puerto Rico, Ireland and a number of other sites throughout the world.Business (Item 1)

Also named by AAPL, ACN, ADI, AGX, BEN, CDNS, CELH, COR and 13 more

Puerto Rico

operates in
Our active ingredient manufacturing and finishing operations, including formulation, filling, assembling, delivery device manufacturing, and packaging, take place at sites in the U.S., including Puerto Rico, Ireland and a number of other sites throughout the world.Business (Item 1)

Also named by AMGN, BMY, BPOP, CCI, COO, GMED, HPE, PWR and 2 more

Regulators

U.S. Food and Drug Administration (FDA)

subject tonamed as a risk
The centrality to our business of the FDA and corresponding international regulators exposes us to risks of oversight, administrative, and enforcement changes, delays, inconsistencies, lapses, or failures, including as may derive from inadequate agency staffing levels, expertise, or resources.Business (Item 1)

Also named by A, ABBV, ABT, AMGN, ARE, ARWR, ATR, AXGN and 112 more

Health Resources and Services Administration (HRSA)

subject tonamed as a risk
For example, in November 2024, Lilly sued the Health Resources and Services Administration (HRSA) over its purported rejection of Lilly’s plan to implement a cash replenishment model to make 340B pricing available to 340B covered entities, in place of the current product replenishment model.Business (Item 1)

Also named by EXEL, UTHR

Laws and programs

Medicaid

subject to · a minimum of 23.1 percent plus adjustments for price increases above the consumer price index over timenamed as a risk
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 the Medicaid and Medicaid Managed Care programs (a minimum of 23.1 percent plus adjustments for price increases above the consumer price index over time) and reduced prices 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).Business (Item 1)

Also named by ABBV, ABT, ARE, ARWR, BAX, BMY, BSX, CHE and 39 more

Inflation Reduction Act of 2022 (IRA)

subject to · 66 percent discountnamed as a risk
In August 2024, HHS announced the government-set prices for these medicines with Jardiance subject to a 66 percent discount compared to the 2023 U.S. calendar year list price for a 30-day supply.Business (Item 1)

Also named by ABBV, APD, ARE, BKH, DD, DHR, ELV, ENPH and 30 more

U.S. Section 232 pharmaceutical tariffs

subject to · three-year grace periodnamed as a risk
The preliminary agreements also provide a three-year grace period during which time our products under a Section 232 investigation will not face tariffs, provided that we meet U.S. manufacturing investment commitments.Business (Item 1)

Also named by COR, GILD, MRK, PFE, REGN

Medicare

subject tonamed as a risk
In January 2026, HHS selected Trulicity and Verzenio as additional medicines subject to government-set prices to be effective in 2028.Business (Item 1)

Also named by ABT, ARWR, AXGN, BAX, BDX, BMY, BSX, CAH and 48 more

340B Drug Pricing Program

subject tonamed as a risk
Changes to the 340B program or the Medicaid programs could have a material adverse impact on our business.Business (Item 1)

Also named by ABBV, BAX, BIIB, BMY, CAH, COR, CVS, EXEL and 13 more

U.S.-China tariffs

subject tonamed as a risk
In 2025, the U.S. government imposed new tariffs on Chinese goods and China responded with tariffs on select U.S. goods.Risk factors (Item 1A)

Also named by ALB, AXGN, MXL, QXO, UCTT, WAT

BIOSECURE Act

subject tonamed as a risk
U.S. officials have enacted and continue to consider legislation or other actions that are intended to limit supply chain reliance on China, including the BIOSECURE Act.Risk factors (Item 1A)

Also named by AMGN, GILD, IONS, REGN

Hatch-Waxman Act

subject tonamed as a risk
Also in the U.S., in addition to the process for challenging patents set forth in the BPCIA, which applies to biological products, the Hatch-Waxman Act provides generic companies substantial incentives to seek to invalidate our patents covering small molecule pharmaceutical products.Risk factors (Item 1A)

Also named by ABBV, INCY, LNTH, VTRS

China National Reimbursement Drug List

subject tonamed as a risk
To facilitate patient access in China, we seek and have secured inclusion of Mounjaro and other 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.Business (Item 1)

Also named by GEHC, MRK

Biologics Price Competition and Innovation Act of 2009 (BPCIA)

subject tonamed as a risk
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.Business (Item 1)

Also named by LGND

U.S. government pricing agreements (November 2025)

subject tonamed as a risk
In November 2025, we announced preliminary voluntary agreements with the U.S. government in which, among other arrangements, we agreed to implement measures to lower Medicaid and certain other drug prices for U.S. patients and to launch new medicines with a more balanced pricing approach across developed nations.Risk factors (Item 1A)

EU Pharmaceutical Legislation

subject tonamed as a risk
For example, an agreement-in-principle announced in December 2025 between the European Commission, Council and Parliament to revise the EU's general pharmaceutical legislation would make conditional the length of certain pharmaceutical intellectual property incentives, including by reductions in maximum data protection periods.Risk factors (Item 1A)