Eton Pharmaceuticals (ETON) Earnings Call Presentation

Financial Performance and Growth Strategy - Eton achieved 16 straight quarters of sequential revenue growth, driven by Alkindi Sprinkle and Carglumic Acid [14] - The company projects a clear path to over $100 million in near-term revenue with the additions of Increlex, Galzin, and ET-400 [23] - Eton expects to exit 2025 with an approximate $80 million revenue run rate [81] - The company anticipates a favorable product mix shift, expecting approximately 70% adjusted gross margin in 2025 and over 75% by 2028 [83] Product Portfolio and Pipeline - Eton has built one of the broadest ultra-rare disease portfolios in the industry, including 13 products and programs [10, 11] - The company acquired two high-value commercial products, Increlex and Galzin, and added three pipeline assets, Amglidia, ET-700, and ET-800 [19, 20] - A return of Increlex to 185 active US patients would produce estimated US revenue of approximately $50 million [28] - The company estimates that harmonizing the US definition of SPIGFD to match the EU would expand the US patient population by approximately 5x to around 1,000 patients [29] - Eton remains highly confident that sales of Alkindi Sprinkle and ET-400 will exceed $50 million annually [43] Upcoming Launches and Milestones - ET-400 has a PDUFA date of May 28, 2025, with a commercial launch planned within 1 week of PDUFA [43] - NDA submission for ET-600 is expected in April 2025 [63] - Potential NDA filing for ET-700 is estimated in 2027, with a clear path to over $100 million of peak sales after approval [54, 56]