Foundayo (orforglipron) received FDA approval for obesity and was launched in the U.S. during Q2 2026; Lilly simultaneously submitted orforglipron for type 2 diabetes in the U.S., EU, and Japan. In the same period, the CHMP issued a positive opinion recommending insulin efsitora alfa for type 2 diabetes in the EU.
Lilly completed three business-combination acquisitions in H1 2026—Ventyx Biosciences (March, ~$1.2B fair value, oral anti-inflammatory), Centessa Pharmaceuticals (June 24, ~$6.6B, orexin-2 agonists for sleep-wake disorders), and Kelonia Therapeutics (June 25, ~$4.9B, in vivo CAR-T)—plus asset acquisitions of Orna Therapeutics (~$1.2B IPR&D, in vivo CAR-T for autoimmune) and Ajax Therapeutics (~$0.9B IPR&D, JAK2 inhibitor). In July 2026 (subsequent event), Lilly acquired three companies for an infectious-disease portfolio for up to $3.9B and signed a ~$2.8B agreement to acquire AtaiBeckley Inc.
Pipeline milestones in Q2 2026: Phase 3 retatrutide trials for obesity and type 2 diabetes each met their primary endpoints; Phase 3 initiations for eloralintide (obesity as incretin add-on, obstructive sleep apnea, and osteoarthritis pain), baricitinib (type 1 diabetes), brenipatide (major depressive disorder), and sofetabart mipitecan (platinum-sensitive ovarian cancer, which also received FDA Breakthrough Therapy designation for platinum-resistant ovarian cancer).
Mounjaro and Zepbound generated $14.9B combined Q2 2026 revenue (Mounjaro $9.9B, +91% YoY; Zepbound $4.9B, +46% YoY) and accounted for 65% of total H1 2026 revenue. U.S. volume growth on both products was partially offset by lower realized prices; outside the U.S., Mounjaro pricing was pressured by its addition to China's National Reimbursement Drug List.
Under voluntary U.S. government drug-pricing agreements finalized in Q1 2026, the Medicare GLP-1 Bridge Program provides Medicare beneficiaries discounted access to Lilly obesity medicines effective July 1, 2026 through December 31, 2027; Lilly states it continues engaging with CMS on long-term Medicare access and notes uptake from the expanded access is unknown. Lilly also undertook significant manufacturing expansion to support anticipated incretin demand, with additional capacity expected to come online over the next several years.
On patent defense: Lilly filed a patent-infringement suit against Cipla in the District of Delaware in June 2026 following Cipla's April 2026 ANDA filing for generic Verzenio. In July 2026 (subsequent event), multiple generic companies filed ANDAs for Mounjaro and/or Zepbound, and Lilly stated it intends to file patent-infringement suits. The Federal Circuit reversed the district court's invalidity finding in the Emgality patent case in April 2026; Lilly filed a petition for rehearing en banc in June 2026.
(Filed on April 30, 2026)
+55.5%
81.9%
$5.3B
The FDA approved orforglipron (Foundayo) for the treatment of obesity (completed in April 2026, disclosed in Q1 10-Q); Lilly also announced a Phase 3 trial for orforglipron in type 2 diabetes met its primary endpoint, and international regulatory submissions for obesity are in progress. In parallel, Lilly initiated Phase 3 trials for eloralintide in three obesity/OSA/OA-pain indications, baricitinib in type 1 diabetes, brenipatide in major depressive disorder, and sofetabart mipitecan in platinum-sensitive ovarian cancer; retatrutide's Phase 3 type 2 diabetes trial met its primary endpoint, and the FDA granted Breakthrough Therapy designation for sofetabart mipitecan in platinum-resistant ovarian cancer.
Lilly completed the acquisition of Ventyx Biosciences in March 2026 for $14.00 per share in cash (approximately $1.1 billion, net of cash acquired), gaining access to oral therapies for inflammatory-mediated diseases, primarily the VTX3232 program. Separately, as of March 31, 2026, Lilly had entered into pending acquisition agreements (subject to closing conditions) with potential aggregate payments of up to approximately $12 billion.
In Q1 2026, Lilly finalized voluntary drug-pricing agreements with the U.S. government, including lower Medicaid and certain other drug prices and a more balanced pricing approach for new medicines across developed nations. Under the Medicare GLP-1 Bridge Program, Medicare beneficiaries will receive discounted Lilly obesity medicines from July 1, 2026 through December 31, 2027, and individual state Medicaid programs may elect to expand access; Lilly is continuing engagement with CMS on longer-term Medicare access to obesity medicines.
Mounjaro and Zepbound together accounted for 65% of total Q1 2026 revenue ($19.8 billion). Mounjaro was launched in all major international markets during the quarter, and Mounjaro's addition to China's National Reimbursed Drug List drove lower realized prices outside the U.S. (outside-U.S. revenue up 81% y/y to $7.7 billion, partially offset by the China NRDL price impact). Lilly noted it has undertaken significant manufacturing expansion with additional capacity expected to become operational over the next several years.
Lilly recognized a charge during Q1 2026 related to the Emgality patent litigation, in which the U.S. Court of Appeals for the Federal Circuit issued an April 2026 opinion reversing the trial court's finding that Teva's patents were invalid and remanding the case; Lilly is assessing next steps. The company also reported that the Ninth Circuit reversed a 2021 summary judgment in Lilly's favor on the Research Corporation Technologies royalty dispute (February 2026), ending that matter with no further payments owed.
(Filed on February 12, 2026)
+42.6%
82.5%
$7.3B
In November 2025, Lilly announced preliminary voluntary agreements with the U.S. government to lower Medicaid and certain other drug prices for U.S. patients, launch new medicines with a more balanced pricing approach across developed nations, and participate in a government direct-to-patient purchasing platform at significant discounts. Under these arrangements, Medicare beneficiaries are expected to have access to discounted Lilly obesity medicines by July 1, 2026, and states will have the option to expand access through Medicaid. The agreements also include a three-year grace period on Section 232 tariffs, contingent on meeting U.S. manufacturing investment commitments. Definitive agreements remained under negotiation as of the filing date (Q4 event; full-year context: Mounjaro and Zepbound together accounted for 56% of total 2025 revenue of $65.2 billion, up 45% year over year).
In December 2025, the European Commission, Council, and Parliament reached an agreement-in-principle on revised EU Pharmaceutical Legislation, which would set a base level of 8 years of data protection with conditional additional incentives while reducing maximum protection available by one year. The implementation timeline and overall market impact were noted as uncertain at the time of the filing (Q4 event; annual context: Lilly's major products such as Mounjaro/Zepbound retain compound patent protection through 2036–2040 across the U.S., Europe, and Japan).
During Q4 2025 (October–December), Lilly repurchased 1.48 million shares totaling approximately $1.5 billion under its $15.0 billion share repurchase program authorized in December 2024, leaving $10.9 billion of remaining authorization as of December 31, 2025. The average price paid per share across the quarter was $1,001.60, with activity concentrated in October and November (472K and 877K shares, respectively) and a smaller December tranche of 130K shares.
Several litigation matters reached milestones in Q4 2025: in November, Lilly and Takeda filed a petition for certiorari to the U.S. Supreme Court in the Actos third-party payer class action (after the Ninth Circuit denied both the class-certification appeal in June and rehearing en banc in August 2025); in December, the Seventh Circuit denied Lilly's petition for rehearing en banc in the Average Manufacturer Price case, where a 2022 jury verdict against Lilly was affirmed in September 2025; and in December, Brazil's superior labor court (TST) significantly reduced the liquidated award in the Cosmopolis facility environmental/employment case, with further appeals possible. (These are Q4 events within a full-year 10-K; the annual filing also discloses ongoing MDL product liability litigation for Mounjaro, Trulicity, and Zepbound, insulin pricing MDLs, and 340B program disputes.)
Annual context (full fiscal year 2025, not Q4-only): Lilly completed the Verve Therapeutics acquisition in July 2025 (cash purchase of ~$549 million plus up to ~$300 million contingent value rights) for genetic medicines in cardiovascular disease; recognized $2.9 billion in acquired in-process R&D charges primarily from the Scorpion Therapeutics PI3Kα inhibitor (STX-478, March 2025) and SiteOne Therapeutics Nav1.8 pain inhibitor (STC-004, July 2025) acquisitions; invested $7.8 billion in capital expenditures for global manufacturing expansion (up from $5.1 billion in 2024), with new sites in North Carolina, Wisconsin, Indiana, Virginia, Texas, Alabama, Pennsylvania, Ireland, Germany, and the Netherlands; and held $1.5 billion in pre-launch inventory at year-end, primarily related to orforglipron. The One Big Beautiful Bill Act, enacted in July 2025, made permanent immediate deductibility of U.S. R&D expenses and 100% bonus depreciation for capital assets. As of the filing date, orforglipron had been submitted for regulatory review in the U.S., EU, and Japan and had received an FDA Commissioner's National Priority Voucher; retatrutide Phase 3 for obesity/osteoarthritis/OSA met all primary and key secondary endpoints.
(Filed on October 30, 2025)
+53.9%
82.9%
$9.8B
Orforglipron Phase 3 trials for obesity and for type 2 diabetes met their primary and all key secondary endpoints; new Phase 3 trials were initiated for hypertension, osteoarthritis knee pain, and stress urinary incontinence (each combined with overweight/obesity). Tirzepatide's Phase 3 cardiovascular outcomes trial in type 2 diabetes met its primary endpoint; a Phase 3 trial for type 1 diabetes was initiated, and the U.S. application for heart failure with preserved ejection fraction was withdrawn.
Regulatory approvals completed: FDA approved imlunestrant (Inluriyo) for ER+, HER2-, ESR1-mutated advanced/metastatic breast cancer; EC approved donanemab (Kisunla) for early symptomatic Alzheimer's disease and pirtobrutinib (Jaypirca) for chronic lymphocytic leukemia; Japan approved mirikizumab (Omvoh) for Crohn's disease. Tirzepatide pediatric/adolescent T2D and insulin efsitora alfa T2D applications were submitted to the FDA and EC.
Completed acquisition of Verve Therapeutics in July 2025 for approximately $549 million net cash plus a contingent value right up to ~$300 million, gaining VERVE-102, a PCSK9 gene-editing medicine in Phase 1b with FDA Fast Track designation for cardiovascular disease. Q3 acquired IPR&D of $655.7 million also included the $494.2 million SiteOne Therapeutics charge for STC-004 (Nav1.8 pain inhibitor, Phase 1).
Tirzepatide supply currently exceeds demand in the U.S. (versus shortage conditions in 2024); the FDA confirmed the previous shortage has ended. Production increases and delivery presentation initiatives are ongoing, with additional manufacturing capacity expected to become operational over the next several years. Pre-launch inventory capitalized as of September 30, 2025 was $952.3 million, primarily related to orforglipron.
Executed contract manufacturing and supply agreements for medicines in development could require up to approximately $9 billion in payments if specified purchase volumes are not met over agreement durations generally up to 8 years. A $200 million sales-based milestone was recognized for the Jardiance product family (Boehringer Ingelheim collaboration) in Q3 2025, with up to $410 million in additional potential milestones in 2026.
