Eton Pharmaceuticals(US:ETON)2025-11-06 21:25Financial Performance - Eton reported Q3 2025 product sales of $22.5 million, representing a 129% increase year-over-year and marking the 19th consecutive quarter of sequential growth[6] - The net loss for Q3 2025 was $1.9 million, or $0.07 per diluted share, compared to net income of $0.6 million, or $0.02 per diluted share in the prior year[23] - Adjusted EBITDA for Q3 2025 was $2.9 million, up from $2.0 million in the prior year period, despite being negatively impacted by INCRELEX ex-U.S. related costs[22] - Total net revenues for the three months ended September 30, 2025, were $22,459,000, compared to $10,324,000 for the same period in 2024, representing a 117% increase[35] - Product sales and royalties, net, increased to $22,459,000 for the three months ended September 30, 2025, from $9,824,000 in the prior year, a growth of 128%[35] - Gross profit for the nine months ended September 30, 2025, was $29,640,000, up from $16,935,000 in 2024, reflecting a 75% increase[35] - For Q3 2025, GAAP net loss was $1.927 million compared to a net income of $0.627 million in Q3 2024[41] - Adjusted EBITDA for Q3 2025 was $2.872 million, up from $1.988 million in Q3 2024, reflecting a significant increase[41] - Total net revenues for Q3 2025 were $22.459 million, with product sales and royalties contributing the entire amount[46] - Gross profit for Q3 2025 was $7.855 million, with a cost of sales of $14.604 million[46] - Non-GAAP net income for the nine months ended September 30, 2025, was $5.418 million, compared to $0.197 million for the same period in 2024[41] Revenue Contributors - INCRELEX was the largest revenue contributor in Q3 2025, with significant progress in raising awareness and expanding access to treatment[7] - ALKINDI SPRINKLE and Carglumic Acid also showed strong year-over-year growth, contributing to overall revenue increases[3] Expenses - R&D expenses increased to $1.1 million in Q3 2025, primarily due to activities related to ET-700 and ET-800 development[19] - G&A expenses rose to $8.1 million in Q3 2025, driven by increased advertising and promotional expenses[20] - The company recognized $1.324 million in inventory step-up expense during Q3 2025, primarily related to INCRELEX®[42] - Research and development expenses for Q3 2025 were $1.112 million, while general and administrative expenses were $8.106 million[46] - The company incurred $1.092 million in stock-based compensation expenses during Q3 2025[43] Cash and Assets - Eton generated $12.0 million in cash from operations during the quarter, with cash and cash equivalents totaling $37.1 million as of September 30, 2025[25] - Cash and cash equivalents increased to $37,121,000 as of September 30, 2025, from $14,936,000 at the end of 2024, a growth of 148%[37] - Total current assets rose to $72,000,000 as of September 30, 2025, compared to $41,021,000 at the end of 2024, representing a 75% increase[37] Liabilities - Total liabilities increased to $81,384,000 as of September 30, 2025, from $51,695,000 at the end of 2024, a rise of 57%[37] - The company recorded stock-based compensation of $4,388,000 for the nine months ended September 30, 2025, compared to $2,383,000 in 2024, an increase of 84%[39] Future Outlook - The NDA for ET-600 was accepted for review by the FDA with a PDUFA date set for February 25, 2026, and launch preparations are underway[4] - The company expects to initiate a bioequivalence study for the revised KHINDIVI formulation by January 2026, aiming for a potential early 2027 approval[13] - Future outlook includes a focus on enhancing product offerings and exploring market expansion opportunities[48]