Eton Pharmaceuticals, Inc. Q3 FY2025 earnings call

• Record quarter with triple-digit year-over-year revenue growth, $22.5M in Q3 product revenue.
• Generated $12 million of cash from operations, reduced adjusted SG&A sequentially.
• INCRELEX revenue and patient count tracking ahead of projections, focus on education and awareness to grow patient count.
• ALKINDI's growth due to sales force focus on pediatric endocrinology, working on KHINDIVI label expansion with revised formulation.
• GALZIN with over 200 active patients, work on ET-700 extended-release version and awareness campaigns.
• ET-600 NDA accepted, PDUFA in Feb 2026, prelaunch activities underway.
• Potential for additional business development transactions to accelerate growth.

Third quarter product revenue was $22.5 million, an increase of 129% year-over-year and up 19% compared to the second quarter. INCRELEX was the largest revenue contributor this year, tracking ahead of original projections. ALKINDI SPRINKLE had strong year-over-year growth, driven by a focused sales force. GALZIN had over 200 active patients, exceeding original targets. Carglumic Acid saw new patient adds. KHINDIVI is working on a label expansion for younger patients. ET-600 NDA was accepted by the FDA with a PDUFA date of February 25, 2026. Revenue contribution: INCRELEX was a major contributor, followed by ALKINDI, GALZIN, and Carglumic Acid.

• Expect strong revenue growth from ALKINDI, INCRELEX, GALZIN, and KHINDIVI.
• Anticipate increased profitability and operating margin expansion.
• ET-600 expected to launch shortly after Feb 25, 2026 PDUFA date.
• Submit KHINDIVI revised formulation supplement in Q2 2026, FDA review expected to take 10 months.
• Complete ET-700 pilot study in mid-2026 and INCRELEX label harmonization study in 2026.
• Potential for additional business development transactions to accelerate growth.

• Dependence on successful label expansions and regulatory approvals for products like KHINDIVI and ET-600.
• Uncertainties in business development transactions and their impact on growth.
• Impact of payer mix on revenue per patient for INCRELEX.
• Competition in the rare disease market affecting market share.

Q: Back out OUS related revenue and costs, what's pro forma gross margins for core U.S. business?

A: Adjusted GAAP gross margins with ex U.S. INCRELEX activity were 35%, adjusted was 45%, and removing ex-U.S. activity is north of 70%.

Q: What's the driver for ALKINDI's reacceleration?

A: Focus of the PDENO sales force, physicians' comfort with the product, and late adopters now believing in it.

Q: INCRELEX gross adds number and trial design timeline?

A: Roughly where last call was, new scripts seen, waiting for FDA feedback on INCRELEX label harmonization study, expect to start study in 2026 if approved.

Q: INCRELEX discontinuation reasons?

A: Primarily patients aging out around age 18, with little traditional discontinuations due to lack of alternatives.

Q: Gross margin cadence beyond 2025?

A: Expect to get to north of 75% by 2028 as product mix shifts to higher-margin products.

Q: Pricing power and pressures?

A: Company prides on appropriate pricing, no significant government or private payer pressures on orphan drug products with few patients.