Eli Lilly Raises 2026 Revenue Guide to $85-87 Billion as Foundayo Shows Late-July Inflection and Retatrutide Filing Hinges on a BLA Dispute with the FDA
Second-quarter 2026 earnings call, August 5, 2026
Eli Lilly reported second-quarter revenue growth of 48% and lifted its full-year revenue guidance by $3 billion at the low end and $2 billion at the high end, to a range of $85 billion to $87 billion. Non-GAAP EPS guidance now stands at $35.50 to $36.50, up $2.78 at the midpoint before the $3.03 of acquired IPR&D charges booked in the quarter. Non-GAAP performance margin guidance rose by 2 percentage points at both ends, to 49% to 50.5%. Q2 non-GAAP EPS was $8.38, against $6.31 a year earlier, with the current period absorbing the larger IPR&D charge. Gross margin reached 86.3%, up roughly 1.3 percentage points, on mix and lower production costs.
Foundayo: Management Claims an Inflection, but the U.S. Launch Has Been Slower Than Expected
The most scrutinized issue on the call was the U.S. launch of Foundayo (orforglipron), Lilly's oral GLP-1. Goldman Sachs' Asad Haider said directly that the launch curve "has been somewhat slower than anticipated." Lilly did not dispute the framing. It pointed instead to recent changes: CVS added the drug in June, completing access across all three major PBMs, the Medicare GLP-1 Bridge started July 1, and broad direct-to-consumer advertising began.
Ilya Yuffa, President of Lilly USA, said the company saw an inflection in the last week of July. "We're almost doubling the volume that we had just a month ago," he said, adding that nearly 1 in 4 new starts are now on Foundayo. The prescriber base has grown to 36,000 from 8,000 at the last earnings call. Yuffa said Lilly is using "every lever" on promotion, including 30-day first-dose sampling similar to a typical retail oral small molecule. Terence Flynn of Morgan Stanley asked whether sampling depresses the IQVIA script data watched each Friday. Management did not quantify an effect.
The disclosed numbers show how early this is. Foundayo generated $67 million in U.S. sales in the quarter. The weekly inflection is a claim about trajectory, not yet visible in reported revenue, so investors will need subsequent quarters to judge it. Lilly also completed its U.S. submission for type 2 diabetes and expects regulatory action later this year.
Ex-U.S., the first full quarter in the UAE produced $31 million in sales, close to half the U.S. figure, which Leerink's Dave Risinger called a sign of "explosive potential." Patrik Jonsson, President of Lilly International, was more measured. He cautioned that the data are early and noisy and that initial sell-in includes inventory build. He said most patients are naive to incretin therapy and that Lilly's combined incretin share held steady even after Novo Nordisk's oral entered the UAE. Haider noted that Novo said that morning it had reached 50% share within three weeks of launch in that market. Lilly's reply was about total incretin share, not oral share, which leaves the head-to-head oral picture there unresolved. Approvals have come in the UAE, Saudi Arabia and Mexico, more than 40 additional countries are under review, and Jonsson said the major rollout will come in early 2027 with no supply gating. Reimbursement for type 2 diabetes will take time, so launch focus will be on chronic weight management.
Retatrutide: Efficacy Is Settled, the Regulatory Pathway Is Not
Lilly reported positive results from three Phase 3 trials, TRIUMPH-1, TRIUMPH-2 and TRIUMPH-3, and said it now has the clinical package to support filings in obesity, obstructive sleep apnea and knee osteoarthritis pain. Chief Scientific Officer Dan Skovronsky said TRIUMPH-1 showed weight loss "approaching bariatric surgery levels" at the highest doses, and that in patients with type 2 diabetes and obesity retatrutide delivered "a magnitude of weight loss not previously seen with incretin therapy." Lilly plans a U.S. submission in the first quarter of 2027.
The filing carries a notable regulatory risk. Lilly intends to file under the BLA pathway, and Bernstein's Courtney Breen asked about the dispute with the FDA over whether retatrutide qualifies as a biologic. CEO Dave Ricks acknowledged the issue is in active litigation, and that the first court decision was "mixed." Lilly argues retatrutide is a biologic under the amino acid count rule and is analogous to a protein. Ricks said Lilly hopes "to come to a conclusion with the FDA" and that it still needs to gather more CMC data. He promised updates on filing status but offered no timeline for resolving the classification. The first-quarter 2027 target therefore depends on a resolution that is not within Lilly's control.
Ken Custer, President of Lilly Cardiometabolic Health, said retatrutide reduced knee pain by 75%, an unprecedented amount. Beyond obesity, Lilly is studying the drug in MASH/MASLD, where the glucagon mechanism may offer an edge, and in chronic lower back pain, which will read out next year. Asked about unauthorized retatrutide already available in the market, Custer said he expects people "will vote with their feet" for the authentic product once approved. That is a reasonable expectation, but it is not a commercial strategy.
Pricing and Guidance: One-Offs Flatter the Quarter
Lilly's headline U.S. price decline of 3% was flattered by changes to estimates for rebates and discounts. Excluding those adjustments, U.S. price fell 9%. Jefferies' Akash Tewari noted that the guide implies a deceleration in revenue growth in the second half. CFO Lucas Montarce said the favorable rebate adjustments and other one-offs of recent quarters will not repeat. He also noted the tough comparison, since the second half of 2025 included a "bolus" of Mounjaro launches in new international markets. He cited seasonality, with Q3 vacations in Europe and a typical Q4 softening in U.S. type 2 diabetes. The guide is therefore best read as conservative on the Medicare and Foundayo ramps, though management did not state this.
Evercore's Umer Raffat pressed on Zepbound net price. By his estimate it is about $580 per prescription, above both the cash price and Wegovy's roughly $380. Montarce confirmed that medical exceptions are a driver and described them as likely "a short-term thing." With CVS access returning starting in Q4, he said: "Expect that price will actually go down for sure because of this, but it's very much embedded in our guide... And of course, we are going to more than offset that with volume growth." Investors should treat this as a direct statement that Zepbound net price has further to fall.
Volume Remains Exceptional, and the Mix Is Shifting to Self-Pay and Abroad
Mounjaro and Zepbound combined for $14.9 billion in revenue, up $6.3 billion year over year. U.S. incretin prescriptions grew 31%, and obesity prescriptions grew 78%. Lilly accounted for about 6 in 10 total obesity prescriptions and about 7 in 10 injectable ones. Self-pay was about 45% of Zepbound total prescriptions and about 55% of new prescriptions, which underscores how much of the growth is now outside traditional insurance channels.
The Medicare GLP-1 Bridge, which gives 20 million eligible Americans coverage at $50 per month out of pocket, adds about 35% more people with coverage for Lilly's obesity medicines. Yuffa said about 80% of Bridge patients are on injectables, and 60% to 70% are new to treatment. That favors Zepbound over the oral, at least initially.
International revenue is accelerating. Europe grew 55% in constant currency, helped by a $250 million Jardiance milestone. China grew 93% and the rest of the world 136%. Lilly's share of the international incretin market rose to about 55%. Montarce acknowledged that with leadership established, "market expansion will be key to driving sustainable growth." On generic semaglutide, Jonsson said Mounjaro prescriptions continue to grow in India and Brazil after generic launches, and that generic producers face supply constraints. Tirzepatide prescriptions in Canada are growing in line with the overall market. Lilly attributes this to its head-to-head superiority data, which it called "the first line of defense." The test will be whether this holds as generic supply improves.
Business Development Broadens into Psychiatry and Vaccines
Lilly announced acquisitions of Curevo, LimmaTech Biologics and the Vaccine Company, which together form a vaccine platform. It also agreed to acquire AtaiBeckley, whose lead asset BPL-003 is a neuroplastogen for treatment-resistant depression with encouraging Phase 2b results. Curevo's amezosvatein is a next-generation shingles vaccine that showed a comparable immune response to the standard of care with better tolerability in Phase 2. LimmaTech's lead program targets surgical site infections. The Vaccine Company is developing an Epstein-Barr virus vaccine with potential relevance to multiple sclerosis.
Bank of America's Jason Gerberry asked whether these are scalable franchises or one-offs. Jake Van Naarden, who heads oncology and business development, declined to commit, saying Lilly will be "opportunistic" and that the common thread is "the immense unmet need." He described the prices paid as allowing Lilly to "remain disciplined." The deals are small relative to Lilly's cash generation but signal a deliberate diversification beyond incretins, with long-dated payoffs. The $3.03 per share IPR&D charge in the quarter shows these deals are not free to earnings.
Oncology, Immunology and Neuroscience Continue to Scale
Lilly said its oncology, immunology and neuroscience medicines grew 121% collectively. Jaypirca grew 56%, and the BRUIN CLL-322 trial showed a 45% reduction in the risk of progression or death when pirtobrutinib was added to venetoclax and rituximab. The reduction was 68% in patients previously treated with a covalent BTK inhibitor. Lilly noted this is the first Phase 3 CLL trial to beat a venetoclax-containing control arm. Inluriyo holds more than 50% of new prescriptions in the U.S. oral SERD market after two full quarters, with the adjuvant EMBER-4 readout due next year. Van Naarden said Lilly plans an all-oral breast cancer combination of imlunestrant, tersolisib (PI3K alpha) and a CDK4/6 inhibitor, as the company manages the post-Verzenio period. Selpercatinib cut the risk of recurrence or death by 83% in the adjuvant RET-positive lung cancer trial LIBRETTO-432.
Ebglyss sales more than doubled, and U.S. share in specialty dermatology rose about 4 percentage points. The FDA approved an every-8-week maintenance option, and every-12-week data are expected in 2027. Kisunla expanded its lead in the anti-amyloid market, with P-tau217 blood tests more than doubling. In earlier-stage work, the VERVE-102 gene-editing program reduced PCSK9 by 88% and LDL cholesterol by 62% at the highest dose in a Phase 1b study. Lilly also started Phase 2 trials of brenipatide in irritable bowel syndrome.
The company said it has more than 40 active Phase 3 programs. Skovronsky described the oncology readout calendar as "probably the richest period" in Lilly's history. Asked what the Street should watch beyond obesity, he said the pipeline would be "really strong and large" even with incretins stripped out.