Strong Full-Year Revenue Growth Driven by Ojemda
Net product revenue of $155.4 million for FY2025, representing a 172% year-over-year increase and double-digit sequential quarterly growth throughout 2025; revenue exceeded combined cost of sales and SG&A within ~20 months of approval.
Robust Q4 Performance
Q4 2025 U.S. Ojemda net product revenue of $52.8 million, a 37% sequential increase over Q3; Q4 prescriptions exceeded 1,300, up 11% quarter-over-quarter despite typical holiday seasonality.
Rapid Adoption and Prescription Volume Growth
More than 4,600 total prescriptions in 2025, representing over 180% growth versus 2024; new patient starts in the second half of 2025 increased ~25% versus the first half.
Confident 2026 Revenue Guidance
Re-iterated 2026 Ojemda net product revenue guidance of $225 million to $250 million (midpoint implies greater than 50% year-over-year growth versus 2025).
Favorable Payer Coverage and Access
High payer dynamics with ~95% coverage, >90% of patients approved on first request, and over 95% of pLGG patients receiving paid drug — minimizing reliance on free drug programs and enabling quick therapy starts.
Strong Balance Sheet and Capital Position
Ended 2025 with approximately $441 million in net cash and no debt, providing financial flexibility to support commercial growth and pipeline advancement; acquisition of Mersana closed in January 2026 to add the EMILY program.
Compelling FIREFLY-1 Three-Year Efficacy Data
FIREFLY-1 three-year data showed a 53% objective response rate (vs 51% at approval), median response duration of 19.4 months, median time to response 5.4 months, median PFS 16.6 months and median time-to-next-treatment (TTNT) of 42.6 months; 45% of patients who progressed on therapy later demonstrated further tumor reduction after continuing treatment.
Pipeline Progress — EMILY and DAY301
Acquired EMILY (a B7-H4 ADC) with monotherapy antitumor activity in adenoid cystic carcinoma (ACC); additional EMILY data and expanded safety set expected mid-2026. DAY301 (PTK7 ADC) is in dose escalation with early signs of antitumor activity and a planned program update in 2026.
Improving Cost Efficiency
Total cost and operating expenses declined year-over-year to $286 million for FY2025 from $348 million in FY2024, and Q4 operating expenses were $81 million versus $95 million in Q4 2024, largely due to absence of one-time 2024 in-licensing expenses.