DAWN — Day One Biopharmaceuticals, Inc.

Summary of Day One Biopharmaceuticals Q3 2025 Earnings Call

1. Key Financial Results and Metrics

• Net Product Revenue: $38.5 million for Q3 2025, a 15% increase from Q2, marking the strongest quarter for revenue and growth in 2025.
• Year-to-Date Revenue: Total of $102.6 million, an 89% increase compared to full year 2024.
• Operating Expenses: $59.6 million, including $9.6 million in noncash stock-based compensation; expenses decreased by approximately 9% compared to Q2.
• Cash Position: $451.6 million in cash with no debt, reflecting a slight decrease from the previous quarter.
• Gross to Net Guidance: Expected to remain between 12% to 15%, currently at the high end due to a price increase and associated Medicaid rebates.

2. Strategic Updates and Business Highlights

• Product Performance: OJEMDA is gaining traction with a significant increase in total prescriptions (18% growth) and new patient starts (almost 20% growth) in Q3.
• Clinical Data: The 2-year FIREFLY-1 data included in the OJEMDA label has bolstered physician confidence, leading to increased adoption, particularly in second-line therapy.
• Pipeline Progress: The company is advancing its pipeline with a mid-2026 EMA approval decision anticipated for OJEMDA in Europe and ongoing enrollment in the FIREFLY-2 Phase III trial.
• Payer Access: Approximately 90% of patients receive payer approval on their first request, facilitating rapid treatment initiation.

3. Forward Guidance and Outlook

• Revenue Guidance: Full-year revenue guidance raised to a range of $145 million to $150 million for 2025, reflecting confidence in continued growth.
• Strategic Priorities: Focus on driving OJEMDA adoption as the standard of care in second-line pLGG, advancing the pipeline, and maintaining disciplined expense management.

4. Bad News, Challenges, or Points of Concern

• Commercial Data Limitations: The data on non-EAP (Expanded Access Program) patients is still maturing, making it difficult to provide detailed insights on persistence and treatment duration.
• Expense Management: While expenses have decreased, a modest increase is expected in Q4 due to planned commercial and clinical activities.
• Market Competition: Concerns regarding off-label MEK inhibitor usage and how the NCCN listing for adult gliomas may influence physician prescribing behavior remain.

5. Notable Q&A Insights

• Patient Persistence: The median duration of treatment for EAP patients is 20 months, which is a positive leading indicator, but data for commercial patients is still developing.
• Impact of Clinical Data: Upcoming 3-year FIREFLY-1 data is anticipated to provide insights on treatment duration and the potential for tumor rebound growth after therapy cessation.
• Physician Adoption: The combination of long-term data and firsthand experience is crucial for increasing physician confidence in prescribing OJEMDA, particularly in the second-line setting.
• Commercial Strategy: The company views new patient starts as critical for long-term revenue growth, with a focus on second-line therapy being more desirable due to a larger patient pool and less complexity.

Overall, Day One Biopharmaceuticals demonstrated strong financial performance and strategic momentum in Q3 2025, with positive outlooks for revenue growth and product adoption, despite some uncertainties in patient data and market competition.