Day One Biopharmaceuticals pany(DAWN) - 2025 Q1 - Earnings Call Transcript

Financial Data and Key Metrics Changes - In Q1 2025, DayOne Biopharmaceuticals reported net product revenue of $30.5 million, reflecting an 11% increase compared to the previous quarter, driven by a 16% growth in quarterly prescriptions [7][22]. - Operating expenses, excluding cost of sales, were $68.9 million, which included $12.9 million in non-cash stock-based compensation. This represented approximately a 4% decline in operating expenses compared to the previous quarter when excluding a one-time charge of $20 million [23]. Business Line Data and Key Metrics Changes - Ogemda's quarterly prescriptions increased to over 900, marking a 16% growth over the prior quarter, contributing to the overall revenue growth [7][12]. - Cumulative U.S. Ogemda prescriptions reached over 2,500 since launch, indicating growing physician confidence and the drug's critical role in treating pediatric low-grade glioma [12][15]. Market Data and Key Metrics Changes - The estimated prevalent pool of approximately 26,000 relapsed or refractory BRAF altered PLGG patients in the U.S. suggests significant growth potential for Ogemda, with about half of these patients likely in long-term remission [16][20]. - The company noted that prescriber adoption continues to increase, with high payer approval rates and patients experiencing longer treatment periods on Ogemda [8][11]. Company Strategy and Development Direction - The company aims to establish Ogemda as the standard of care in second-line plus pediatric low-grade glioma and to drive revenue growth through clinical development and portfolio expansion [6][10]. - DayOne is focused on advancing its clinical development pipeline, particularly the FIREFLY two and DAY three zero one programs, while also exploring business development opportunities to expand its multi-program clinical stage portfolio [10][11]. Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the steady increase in Ogemda revenue, citing strong market dynamics and a solid financial foundation that allows for strategic investments despite macroeconomic challenges [11][24]. - The company does not project the need for additional financing in the future, emphasizing disciplined financial management alongside growth opportunities [24]. Other Important Information - The company reported a cash balance of $473 million and no debt at the end of Q1 2025, positioning it well for future growth [23][24]. - Management highlighted the importance of educating physicians on the long-term effects and benefits of Ogemda to enhance adoption rates [55][58]. Q&A Session Summary Question: What are you seeing in terms of duration of therapy in the marketplace and how docs plan to use the drug long term? - Management noted that it is early to comment on duration but observed a high percentage of patients continuing therapy month after month, consistent with expectations from the FIREFLY one study [27][29]. Question: Can you provide a rough percentage of revenue from new patients versus ongoing patients? - Management indicated that the dynamics of new patient starts and ongoing patients remain similar to previous discussions, with approximately 90% on-label and 10% off-label usage [33][34]. Question: What headwinds did you see in Q1 regarding gross to net and reimbursement? - Management acknowledged seasonality in January due to delays in scans and appointments but noted a strong rebound in new patient starts in April [35][36]. Question: How should we think about new patient starts from here? - Management expects a consistent and steady ramp of new patients over time, emphasizing that this is akin to a rare disease launch rather than typical oncology trajectories [44][45]. Question: Can you talk about penetration within each of the priority centers? - Management reported that 100% of priority one accounts have tried Ogemda, with ongoing efforts to deepen prescribing and expand usage among physicians [51][52].