Eton Pharmaceuticals, Inc. Q2 FY2025 earnings call

• Record second quarter with $18.9M revenue, 108% YoY growth.
• 3 product launches planned in 2025, with ET-600 NDA accepted and assigned a February 2026 PDUFA date.
• Increlex relaunch led to record sales, reaching 100 active patients 5 months ahead of schedule.
• Khindivi FDA approved on May 28th, launched soon after, part of the adrenal insufficiency franchise.
• Galzin access issues addressed with a patient support program, aiming for 200 active patients by year-end.
• ET-600 NDA submitted, with potential Q1 2026 launch.
• Generated $8 million of cash flow from operations and $3.1 million of adjusted EBITDA, highlighting profitability.

Revenue for the second quarter was $18.9 million, a remarkable 108% increase over the prior year period. Key product segments: Increlex saw over 100% year-over-year revenue growth, with 100 active patients reached 5 months ahead of the end-2025 goal. Alkindi Sprinkle continues robust growth, and Khindivi was FDA approved and launched soon after. Galzin has improved access issues with its patient support program. Revenue contribution from Alkindi Sprinkle, Increlex, and Khindivi was significant, driving the overall growth.

• Originally expected to exit 2025 at an $80 million revenue run rate, now expects to reach this in the third quarter of 2025, 3 months ahead of schedule.
• Adjusted gross margin expected to be approximately 70% for full year 2025 and reach 75% by 2028.
• Adjusted G&A spending expected to remain flat or slightly decline in the second half of 2025 as 2025 marketing spend was weighted in the first half.

• Khindivi label currently restricted to patients 5 years and older; a follow-on study is needed to expand to younger patients, with timing and cost uncertain.
• EU vs US definitions for Increlex may require a follow-on clinical study to harmonize definitions, timing and cost of such a study are unclear.
• Dependence on successful product launches and acquisitions for continued growth, with uncertainties around execution of these initiatives.

Q: Thoughts on Khindivi and Alkindi momentum, patient growth?

A: Some physicians have converted patients 5 and above to Khindivi, and the launch is moving along. The combined franchise is on track to exceed $50 million, with the real opportunity when Khindivi's label is expanded to include younger patients.

Q: Increlex trial design with FDA?

A: Plan to initiate an open-label IND to enroll patients with IGF levels between -2 and -3 standard deviations, working on protocol design to submit to the FDA.

Q: Beat source and second half driver?

A: The beat is heavily weighted toward Increlex, with growth also from Alkindi and Galzin. SG&A spending is expected to ramp down in the second half of 2025 as 2025 marketing spend for product launches is mostly completed.

Q: Khindivi label expansion study details?

A: A revised formulation with reduced excipient concentration is being submitted in the first quarter of 2026, with the aim of obtaining a wider label by the end of 2026, which would open up a larger patient population for Khindivi.