Eton Pharmaceuticals, Inc. Q1 FY2025 earnings call

• Acquired and relaunched Increlex and Galzin; Alkindi continues strong growth. - ET-400 near approval with PDUFA date in 2 weeks. - Pipeline progress: ET-600 submitted NDA after pivotal bioequivalency study; ET-700 in development for Wilson disease; Amglidia and ET-800 in various stages. - Business development: Focus on acquisitions and licensing aligned with ultra-rare disease strategy, disciplined in evaluating opportunities.

Increlex: Added to the portfolio in Q4 2024. Currently has over 90 active patients, aiming for 100 by year-end. International rights out-licensed to Esteve for $4.3M upfront. Alkindi: Has seen 17 straight quarters of sequential growth, with increased referrals in 2025. Galzin: Relaunched in March with $0 co-pay, converting patients to Eton's infrastructure, expected to contribute meaningfully by end of Q3. Metabolic Portfolio: Provides steady revenue but has reduced significance due to growth in high-margin pediatric endocrinology products.

• Expect product sales to continue growing quarter-over-quarter in 2025, aiming for ~$80M annual revenue run rate by end of 2025. - Full-year 2025 adjusted gross margin expected at ~70%, long-term to exceed 75% by 2028. - ET-400 anticipates approval in ~2 weeks, with launch soon after. - Planning FDA meeting for Increlex label expansion in coming weeks, submission in Q3 for label update.

• Tariffs: Minimal impact as majority products made in US, European purchases <5% of forecasted revenue. - Regulatory Delays: Potential delays in FDA reviews for label expansions or product approvals. - Market Adoption: Slow adoption of Galzin or other products due to historical access/affordability issues, though relaunch efforts are addressing this.

Q: Have you had a meeting with FDA to discuss Increlex label expansion?

A: The meeting request has gone in. We'll look forward to having it in the coming weeks, possibly most likely July, with submission in the third quarter of the actual update.

Q: Any additional color on ET-400 FDA interaction?

A: The last step in the review process is labeling discussions. We've received commentary, sent the submission back to the agency, and are on track for approval in 2 weeks or less.

Q: Amglidia FDA feedback?

A: We liked the feedback from the agency, they provided a pathway. We have a few clarifying questions and plan a follow-up meeting, expecting a fairly straightforward PK study for NDA filing.

Q: Increlex patient numbers and ET-400 revenue timing?

A: Increlex has over 90 patients, ET-400 revenue expected in Q3/Q4.

Q: Galzin feedback and patient numbers?

A: Galzin relaunch going well, adding patients weekly, patient numbers to be updated in next report.

Q: Medicaid rebates and receivables?

A: Receivables increase due to Increlex sales and licensing revenue; Medicaid liability increase due to Increlex product relaunch.