Eli Lilly and Company (LLY) SEC Filings & Earnings Calls

Litigation risk from pricing practices

“We have been subject to various investigations and received subpoenas, civil investigative demands, information requests, interrogatories, and other inquiries from various governmental entities related to the pricing and sale of our medications” · word for word

Patent litigation risk

“In July 2026, Lilly received notice that multiple generic companies had filed ANDAs seeking approval to market generic versions of Mounjaro and/or Zepbound before the expiration of some or all of the patents listed for those products in the FDA’s Orange Book.” · word for word

Acquisition integration risk

“Asset impairment, restructuring, and other special charges recognized during the three and six months ended June 30, 2026 were $703 million and $982 million, respectively, primarily related to the accelerated vesting of employee equity awards and other acquisition and integration costs associated with the closing of our acquisitions of business combinations.” · word for word

Acquired IPR&D charges of $3.03 per share in Q2 2026, significantly higher than $0.14 in prior year, reflecting aggressive business development spend.

“Q2 2026 reported and non-GAAP EPS included $3.03 of acquired IPR&D charges compared to $0.14 in Q2 2025” · word for word

Realized prices declined 13% globally (9% in US ex adjustments), driven by Zepbound/Mounjaro and NRDL inclusion in China, indicating pricing pressure.

“13% decrease in realized prices; U.S. price would have declined by approximately 9% excluding adjustments”

If Centessa Acquisition not consummated by outside date, mandatory redemption of certain notes at 101% of principal.

“Centessa Special Mandatory Redemption triggered if acquisition not completed by March 31, 2027 or later agreed outside date.”

Patent litigation risk for Emgality

“In April 2026, the U.S. Court of Appeals for the Federal Circuit issued an opinion reversing the trial court's finding that the patents are invalid and remanding to the district court, and we recognized a charge related to the matter during the three months ended March 31, 2026.” · word for word

Pricing and reimbursement pressure

“We have been subject to various investigations and received subpoenas, civil investigative demands, information requests, interrogatories, and other inquiries from various governmental entities related to pricing issues, including the pricing and sale of insulin medications.” · word for word

Product liability litigation for incretin medicines

“Since August 2023, various plaintiffs have filed lawsuits against us, Novo Nordisk A/S, and other related entities, alleging various injuries following purported use of incretin medicines, including Mounjaro, Trulicity, and Zepbound.” · word for word

Lower realized prices due to NRDL in China and competitive pricing pressure on Zepbound and Taltz.

“Lower realized prices outside the U.S. driven primarily by addition of Mounjaro to NRDL in China... decline in realized prices was primarily driven by Zepbound and Taltz.” · word for word

Gross margin contraction of 0.6pp due to pricing pressure.

“Gross margin as a percent of revenue was 81.9%, a decrease of 0.6 percentage points... lower realized prices.” · word for word

Acquired IPR&D charges of $584M in Q1 2026, though lower than prior year.

“Acquired IPR&D charges of $584 million compared with $1.6 billion in Q1 2025.”

Litigation-related charges of $279M in Q1 2026.

“Asset impairment, restructuring and other special charges of $279 million in Q1 2026 were primarily related to litigation matters.” · word for word

Litigation and regulatory risk from commercial practices

“In August of 2025, the state of Texas sued for allegedly bribing and inducing medical providers to prescribe its most profitable drugs, including the high-demand GLP-1 medications” · word for word

Pricing and access pressure on insulin

“An ongoing battle between Michigan and the company continues. The state is trying to investigate Eli Lilly's pricing practices around insulin” · word for word

Antitrust/price-fixing litigation

“Eli Lilly is one of three pharmaceutical companies named as defendants in a lawsuit filed July of this year on behalf of the University of Pennsylvania and its health system. The suit alleges 20 years of price fixing on drugs that treat diabetes, like insulin” · word for word

IRA price setting risk

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

Tariff cost risk

“While pharmaceuticals are exempt from certain of these tariffs, such exemptions may be terminated... we may not be able to share the burden of increased costs from tariffs and related impacts to any meaningful degree.” · word for word

Counterfeit incretin risk

“We continue to see the production, marketing, and sale of counterfeit, misbranded, adulterated, and mass-compounded incretins.” · word for word

R&D failure risk

“Pharmaceutical research and development is very costly and highly uncertain; we may not succeed in developing, licensing, or acquiring commercially successful products.” · word for word

Dependence on Mounjaro and Zepbound for growth; any competitive or regulatory pressure could impact revenue.

“Revenue in Q4 2025 increased 43% to $19.3 billion driven by volume growth from Mounjaro and Zepbound.” · word for word

Lower realized prices partially offset volume growth, indicating pricing pressure.

“partially offset by a 5% decrease due to lower realized prices.” · word for word

No material risk; board appointment is routine.

“Dr. Bertozzi is independent under applicable standards.” · word for word

Lower realized prices due to rebates and discounts, though partially offset by volume.

“Price was negatively impacted by a favorable one-time adjustment to estimates for rebates and discounts in Q3 2024.” · word for word

Acquired IPR&D charges and litigation costs impacting reported earnings.

“acquired in-process research and development (IPR&D) charges of $655.7 million; Asset impairment, restructuring and other special charges of $364.9 million” · word for word

Pricing and reimbursement pressure

“continued pricing pressures and the impact of actions of governmental and private actors affecting pricing of, reimbursement for, and patient access to pharmaceuticals” · word for word

Intellectual property expiration

“the expiration of intellectual property protection for certain of our products and competition from generic and biosimilar products” · word for word

Manufacturing and supply chain risk

“issues with product supply and regulatory approvals stemming from manufacturing difficulties, disruptions, or shortages” · word for word