Day One Reports Fourth Quarter and Full Year 2025 Financial Results and Reaffirms 2026 Outlook and Revenue Guidance

Core Insights - Day One Biopharmaceuticals reported significant growth in net product revenues for OJEMDA, achieving $52.8 million in Q4 and $155.4 million for the full year 2025, representing a 172% year-over-year increase [7][16] - The company projects U.S. net product revenue for OJEMDA to reach between $225 million and $250 million in 2026 [7][3] - The CEO highlighted 2025 as a pivotal year for the company, emphasizing strong commercial execution and advancements in their pipeline, which positions them for continued growth [3][2] Financial Performance - OJEMDA's prescription volumes increased to 1,394 in Q4 2025, with total prescriptions for the year reaching 4,635, marking an 181% growth compared to 2024 [7] - Research and development expenses for 2025 were $148.1 million, down from $227.7 million in 2024, while selling, general, and administrative expenses increased to $120.6 million from $115.5 million [14][16] - The net loss for the company was $107.3 million for the full year 2025, compared to a net loss of $95.5 million in 2024 [14][16] Pipeline Developments - The company is advancing its clinical pipeline, with the pivotal Phase 3 FIREFLY-2 trial for OJEMDA in frontline pLGG on track for full enrollment in the first half of 2026 [7][5] - Updated clinical data for Emi-Le, a new ADC targeting adenoid cystic carcinoma, is expected to be available by mid-2026 [7][11] - The Phase 1a clinical trial of DAY301 is progressing, with initial data anticipated in the second half of 2026 [7][11] Cash Position - As of December 31, 2025, the company reported cash, cash equivalents, and short-term investments totaling $441.1 million, down from $531.7 million in 2024 [17]