DAWN — Day One Biopharmaceuticals, Inc.

Summary of Day One Biopharmaceuticals, Inc. Q4 2025 Earnings Call

1. Key Financial Results and Metrics

• Q4 2025 Net Product Revenue: $52.8 million, a 37% sequential increase from Q3.
• Full Year 2025 Net Product Revenue: $155.4 million, up 172% year-over-year, with double-digit sequential growth throughout the year.
• Total Prescriptions: Over 4,600 for the year, representing more than 180% growth compared to 2024.
• Cash Position: Ended 2025 with over $440 million in cash and no debt.
• Cost and Operating Expenses: $81 million in Q4 and $286 million for the full year, down from $348 million in 2024, primarily due to the absence of one-time expenses.

2. Strategic Updates and Business Highlights

• Ojemda Launch: Continued strong uptake in pediatric low-grade glioma (pLGG), with efforts to establish it as the standard of care in second-line therapy.
• Clinical Data: Three-year follow-up data from the FIREFLY-1 trial reinforced Ojemda's efficacy and safety, showing a 53% objective response rate and a median time to next treatment of 42.6 months.
• Pipeline Expansion: Acquisition of Mersana Therapeutics, integrating the EMILY program targeting adenoid cystic carcinoma (ACC), and ongoing development of DAY301.
• Market Dynamics: 95% coverage rates for Ojemda, with over 90% of patients approved on the first request, indicating favorable payer dynamics.

3. Forward Guidance and Outlook

• 2026 Revenue Guidance: Reiterated expectation of $225 million to $250 million in net product revenue for Ojemda, implying over 50% growth year-over-year.
• Clinical Trials: Anticipation of completing enrollment in the FIREFLY-2 trial in the first half of 2026, with top-line results expected in mid-2027.

4. Bad News, Challenges, or Points of Concern

• Market Education: The impact of the three-year FIREFLY data on sales is expected to be gradual, as broader physician awareness is still needed, pending a peer-reviewed publication.
• Competition and Adoption: While Ojemda is gaining traction, establishing it as the standard of care in the second-line setting remains a challenge, requiring ongoing education and confidence-building among healthcare providers.

5. Notable Q&A Insights

• Persistence on Therapy: Management discussed strategies to improve patient persistency on Ojemda, including targeting earlier-line relapsed patients and enhancing physician training on dose adjustments.
• EMILY Program: Questions regarding the EMILY program's data release and potential registrational trials highlighted the urgency for new therapies in ACC, with management optimistic about the upcoming data.
• Market Trends: Early 2026 trends appear strong, with management confident in maintaining growth momentum, although specific quarterly performance details were not disclosed.

Overall, Day One Biopharmaceuticals demonstrated significant financial growth in 2025, with strong prospects for continued expansion in 2026, despite challenges in market education and competition.