Eli Lilly (LLY) GLP-1 business: Mounjaro, Zepbound, Foundayo

Key points

• In the nine months ended 30 September 2026, Lilly reported $29.3 billion of Mounjaro and $14.4 billion of Zepbound revenue out of $67.2 billion in total [1][2]. Lilly says Mounjaro, Zepbound and Foundayo together were 66 percent of revenue [1].
• Foundayo (orforglipron), an oral GLP-1 pill, was approved by the FDA for obesity on 1 April 2026 [4]. Retatrutide is not approved anywhere we could verify; bimagrumab is still Phase 2 [1][3][9][10].
• Lilly’s own filings list supply, pricing and reimbursement, compounding, safety and patents among the risks to these products [3].
• This article reports what filings, regulators and registries say. It makes no forecast and no recommendation.

What this article uses

The latest earnings release available on 2026-11-08 is Lilly’s third-quarter 2026 press release, dated 29 October 2026 (Exhibit 99.1 to a Form 8-K) [2]. The matching Form 10-Q was filed the same day [1]. The latest annual report is the 10-K for 2025, filed 12 February 2026 [3]. Lilly’s investor website blocked our automated requests, so we used SEC copies and did not read other Lilly press releases directly.

How much revenue comes from the incretin drugs

Lilly reported third-quarter 2026 revenue of $24,397 million, up 39 percent from $17,601 million a year earlier. It attributed the rise to a 53 percent increase in volume, partly offset by a 15 percent fall in realized prices [2]. The quarter included about $900 million of benefits, mainly $410 million of Jardiance milestones and favorable rebate and discount adjustments [2].

Revenue by product, in millions of US dollars, as Lilly reported it [1][2]:

Product	Q3 2026	Nine months 2026	Share of nine-month revenue (our arithmetic)
Mounjaro (tirzepatide)	10,723	29,328	43.7%
Zepbound (tirzepatide)	5,352	14,440	21.5%
Foundayo (orforglipron)	184	281	0.4%
Verzenio	1,511	4,286	6.4%
Jardiance family	1,578	3,924	5.8%
Trulicity	904	3,042	4.5%
Taltz	856	2,444	3.6%
Total revenue	24,397	67,170	100%

Jardiance revenue is Lilly’s share of sales under a collaboration with Boehringer Ingelheim and includes milestones [1]. Mounjaro revenue outside the US was $15.3 billion of the $29.3 billion nine-month figure; Lilly tied lower realized prices abroad mainly to Mounjaro’s listing on China’s National Reimbursement Drug List [1][2].

For 2025, the 10-K reports Mounjaro at $22,965 million and Zepbound at $13,542 million of $65,179 million total, which Lilly states was 56 percent of revenue. Six products, including those two, made up 82 percent [3]. Lilly’s 2026 revenue guidance is $91 billion to $92 billion, raised from $85 billion to $87 billion [2]. That is the company’s forecast, not a result.

Approval status

Product	Status as of 2026-11-08	Source
Zepbound (tirzepatide)	FDA label: weight reduction and long-term maintenance in adults with obesity, or overweight with at least one weight-related condition; moderate to severe obstructive sleep apnea in adults with obesity	[5]
Mounjaro (tirzepatide)	FDA label: type 2 diabetes in adults and in children aged 10 and older; reducing major cardiovascular events in adults with type 2 diabetes at high risk	[6]
Foundayo (orforglipron)	FDA approved 1 April 2026 for obesity, or overweight with a weight-related condition. Submitted for type 2 diabetes in the US and Japan	[1][4][7]
Foundayo, EU	EMA’s CHMP adopted a positive opinion on 15 October 2026 for weight management and type 2 diabetes. We found no European Commission decision	[8]
Retatrutide	Phase 3. Lilly’s 10-Q does not report a regulatory submission	[1]
Bimagrumab	Phase 2	[3][10]

The 10-Q lists the Mounjaro cardiovascular approval as a development since the 10-K [1]. The 10-K also reports EU approval of tirzepatide for heart failure with preserved ejection fraction, US and EU approval for pediatric type 2 diabetes, and Phase 3 programs in metabolic liver disease, obesity morbidity and mortality, and type 1 diabetes [3]. Both tirzepatide labels carry a boxed warning about thyroid C-cell tumors seen in rats [5][6].

For orforglipron, the FDA said approval rested on two randomized, double-blind, placebo-controlled 72-week trials and called it the first new molecular entity approved under its Commissioner’s National Priority Voucher pilot [4]. The FDA page gave no trial sizes. Lilly says it launched Foundayo in the US in the second quarter of 2026 [1].

Retatrutide and bimagrumab

Retatrutide is a triple-agonist injection candidate. ClinicalTrials.gov lists 14 Phase 3 records that name it, as of 2026-11-08: five completed and nine active or recruiting [9]. The largest is a cardiovascular and kidney outcomes trial (NCT06383390), planned at 10,000 participants, with a primary completion date of February 2029 [9]. A head-to-head trial against tirzepatide (NCT06662383, 800 participants) lists a primary completion date of November 2026 [9].

Lilly’s 10-Q says Phase 3 trials in obesity and in type 2 diabetes met their primary endpoints, and its release headlines a head-to-head trial against Ozempic in type 2 diabetes [1][2]. The registry has a Phase 3 comparison with semaglutide (NCT06260722, 1,250 participants) that may be that trial; the release does not give the identifier [2][9]. We do not summarize results here; see what is public about the retatrutide Phase 3 program and the retatrutide compound page.

Retatrutide has no approval we could verify, so retatrutide sold online is an unapproved product, and “research use only” labeling does not change that. The Q3 release lists an announcement in which Lilly calls on platforms, payment companies and regulators to shut down “the illegal retatrutide black market” [2]. We did not open that announcement itself.

Bimagrumab is an antibody that Lilly acquired with Versanis Bio in August 2023, booked as a Phase 2 asset with a $604 million acquired in-process R&D charge [3]. The registry’s obesity-related bimagrumab trials are all Phase 2: with semaglutide (NCT05616013, 507 participants, completed) and with tirzepatide (NCT06643728, 252 participants, active not recruiting; NCT05933499, 63 participants, recruiting) [10]. We found no Phase 3 obesity trial. Older Phase 3 and Phase 2/3 records under the earlier code BYM338 concern inclusion body myositis [10].

Manufacturing investments

Lilly’s 10-K lists new manufacturing sites in North Carolina, Wisconsin, Indiana, Virginia, Texas, Alabama, Pennsylvania, Ireland, Germany and the Netherlands [3]. Capital expenditures were $7.8 billion in 2025 against $5.1 billion in 2024, and Lilly expects them to be “meaningfully higher” [3]. Purchases of property and equipment were $8,437 million in the first nine months of 2026 against $5,294 million a year earlier [1]. Supply and contract-manufacturing agreements could require payments of up to about $10 billion if Lilly does not buy specified amounts [3]. The Q3 release mentions groundbreakings in Houston and Richmond and describes Houston as one of ten US sites announced since 2020 [2]. Per-site dollar amounts were in Lilly releases we could not read, so we do not state them.

Direct-to-consumer sales and pricing

The 10-K describes LillyDirect as a direct-to-patient platform in which third-party pharmacies dispense and deliver select Lilly medicines. It says self-pay sales through LillyDirect “represented a growing portion” of the business in 2025 [3]. Lilly gave no dollar figure in the filings we searched.

LillyDirect’s own pages, read on 2026-11-08, state self-pay prices [11][12]:

• Zepbound KwikPen and single-dose vial prices start at $299 a month for the lowest strength; higher strengths are listed between $399 and $449 a month with a refill-timing program, and $499 to $699 otherwise [11].
• Foundayo starts at $149 a month for the lowest strengths, with the two lowest strengths “temporarily reduced” through 31 December 2026, and $299 for the highest strengths [12].
• For commercially insured patients, both pages say “as low as $25” a month, subject to terms [11][12].

These are list prices from the company’s pages on one date, and Lilly can change them. The 10-Q says Medicare beneficiaries have access to discounted Lilly obesity medicines from 1 July 2026 through 31 December 2027 under the Medicare GLP-1 Bridge program, with long-term access still under discussion with CMS [1].

Competition

Lilly’s filings describe competition in general terms: effectiveness, safety, ease of use, formulary placement and price, plus growing competition from China. In the US, self-insured employers generally must opt in to cover anti-obesity medicines, and many international payers do not cover them, which leaves patients to self-pay [3]. For share data and a comparison with Novo Nordisk, see Lilly vs Novo Nordisk: GLP-1 market share. We did not use third-party market-share figures here.

Risks and unknowns

The risk factors below are Lilly’s own, from the 10-K and 10-Q [1][3].

• Concentration. Lilly says patent loss, safety concerns, litigation, counterfeit and illegally compounded drugs, pricing and “actual or perceived supply shortages” could materially affect results [3].
• Supply. Manufacturing, quality or supply-chain problems could cause shortages; capacity expansion has long lead times; parts of the supply chain depend on China-based suppliers [3].
• Pricing and reimbursement. Lilly cites government price controls, its voluntary agreements with the US government, Inflation Reduction Act price setting (Trulicity and Verzenio were selected in January 2026, effective 2028), pharmacy benefit managers, and the risk that expanded access does not offset price concessions [1][3]. Q3 realized prices fell 15 percent [2].
• Compounding and counterfeits. Lilly says mass-compounded and counterfeit incretins may harm patients and cause “net price erosion”. It states that the FDA confirmed in late 2024 that the tirzepatide shortage had ended, and that it cannot guarantee compliance [1][3].
• Safety. Post-approval use in larger populations can reveal new concerns, and concerns about compounded products or the drug class could be attributed to Lilly’s products [3]. The 10-Q describes lawsuits since August 2023 against Lilly and Novo Nordisk over incretin medicines, mostly in two federal proceedings in the Eastern District of Pennsylvania, one on gastrointestinal injuries and one on non-arteritic anterior ischemic optic neuropathy [1]. The tirzepatide and orforglipron labels list pancreatitis, severe gastrointestinal reactions, gallbladder disease, kidney injury from volume loss and hypersensitivity among warnings [5][7].
• Patents. Lilly’s estimated expiry for the tirzepatide compound patent is 2036 in the US, 2037 in major European countries and 2040 in Japan, with US data protection to 2027. It expects its US patents to be routinely challenged [3].
• Not verified. LillyDirect’s share of sales, a European Commission decision on Foundayo, and the date of the Mounjaro cardiovascular approval.

Frequently asked questions

How much of Lilly’s revenue is Mounjaro and Zepbound? For the nine months ended 30 September 2026, Mounjaro was $29,328 million and Zepbound $14,440 million of $67,170 million, about 65 percent combined by our arithmetic [1][2]. Lilly reports that these two plus Foundayo made up 66 percent [1]. For 2025, Lilly reported 56 percent for Mounjaro and Zepbound [3].

Is Foundayo the same as orforglipron? Yes. Lilly’s 10-Q states that orforglipron is branded as Foundayo [1]. The FDA approved it for obesity on 1 April 2026 [4]; type 2 diabetes is under review in the US and Japan [1].

Is retatrutide approved? We found no approval in the US, EU or elsewhere. Lilly’s 10-Q describes Phase 3 trials that met primary endpoints, and ClinicalTrials.gov shows further Phase 3 trials ongoing [1][9].

Sources

1. Eli Lilly and Company, Form 10-Q for the quarter ended 30 September 2026 (filed 2026-10-29). https://www.sec.gov/Archives/edgar/data/59478/000005947826000108/lly-20260930.htm
2. Eli Lilly and Company, “Lilly reports third-quarter 2026 financial results, raises full-year guidance and highlights regulatory progress across the portfolio,” Exhibit 99.1 to Form 8-K (2026-10-29). https://www.sec.gov/Archives/edgar/data/59478/000005947826000104/q326lillysalesandearningsp.htm
3. Eli Lilly and Company, Form 10-K for the year ended 31 December 2025 (filed 2026-02-12). https://www.sec.gov/Archives/edgar/data/59478/000005947826000013/lly-20251231.htm
4. U.S. Food and Drug Administration, “FDA Approves First New Molecular Entity Under National Priority Voucher Program” (2026-04-01). https://www.fda.gov/news-events/press-announcements/fda-approves-first-new-molecular-entity-under-national-priority-voucher-program
5. DailyMed (NLM), Zepbound (tirzepatide) prescribing information, label version published 2026-09-02. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=487cd7e7-434c-4925-99fa-aa80b1cc776b
6. DailyMed (NLM), Mounjaro (tirzepatide) prescribing information, label version published 2026-09-02. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=d2d7da5d-ad07-4228-955f-cf7e355c8cc0
7. DailyMed (NLM), Foundayo (orforglipron) prescribing information, label version published 2026-08-13. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=8ac446c5-feba-474f-a103-23facb9b5c62
8. European Medicines Agency, Foundayo (orforglipron) CHMP opinion page, opinion adopted 2026-10-15 (read 2026-11-08). https://www.ema.europa.eu/en/node/288002
9. ClinicalTrials.gov, query for intervention “retatrutide” via API v2 (read 2026-11-08). https://clinicaltrials.gov/api/v2/studies?query.intr=retatrutide
10. ClinicalTrials.gov, query for intervention “bimagrumab” via API v2 (read 2026-11-08). https://clinicaltrials.gov/api/v2/studies?query.intr=bimagrumab
11. Eli Lilly and Company, LillyDirect Zepbound page (read 2026-11-08; page undated). https://www.lilly.com/lillydirect/zepbound
12. Eli Lilly and Company, LillyDirect Foundayo page (read 2026-11-08; footer code dated 09/2026). https://www.lilly.com/lillydirect/foundayo

This article is information, not medical advice.

This is not investment advice.