Day One Biopharmaceuticals pany(DAWN) - 2024 Q4 - Earnings Call Transcript

Financial Data and Key Metrics Changes - For the full year 2024, net product revenues totaled more than $57 million, representing approximately eight months of sales following OJEMDA's April approval [10] - Fourth quarter net product revenues were$29 million, which represents a 44% growth compared to Q3 [11] - Total revenue for the fourth quarter of 2024 was $29.2 million, including$29 million in net product revenue and $200,000 from license revenue [37] - Operating expenses were$91.6 million for Q4 2024, compared to $59.5 million for Q4 2023, driven primarily by commercial investments and a one-time charge of$20 million in R&D expense [40] Business Line Data and Key Metrics Changes - OJEMDA's launch performance in 2024 showed consistent growth in quarterly net revenues, with Q4 nearly doubling the number of prescriptions in Q2 and Q3 combined [21] - The company achieved over 1,600 cumulative total prescriptions, with Q4 contributing approximately 800 new prescriptions [20][75] - The gross to net deductions improved in Q4 due to CMS granting OJEMDA an exclusively pediatric designation, reducing the Medicaid and 340B minimum rebate percentage from 23.1% to 17.1% [39] Market Data and Key Metrics Changes - OJEMDA has broad coverage, with over 75% of covered lives having published policies and about 95% of on-label patients receiving coverage [30] - The company reported that over 80% of pLGG patients received coverage approval for OJEMDA on their initial request in Q4 [31] Company Strategy and Development Direction - The company aims to continue driving OJEMDA revenue growth, advancing its pipeline, and expanding with programs that have potential to become important new medicines [16] - The focus is on acquiring and in-licensing programs that have the potential to be first or best-in-class, supported by a strong financial position [17] - The company plans to establish OJEMDA as the standard of care in treating relapsed or refractory BRAF-altered pLGG [33] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth trajectory of OJEMDA, emphasizing the importance of increasing the prescriber base and patient usage [32] - The company anticipates steady growth in new patient starts, with no singular inflection point expected [61] - Management highlighted the strong cash position of over $500 million, which provides the ability to operate and invest in growth opportunities [15] Other Important Information - The company ended 2024 with a cash balance of$531.7 million, allowing for continued investment in growth opportunities [41] - The company will no longer book revenue for its named patient program starting in 2025, which previously contributed approximately $3 million in 2024 [38] Q&A Session Summary Question: When might guidance for OJEMDA be provided? - Management indicated that guidance will depend on consistency in revenue growth and treatment duration, which will take time to understand [47] Question: What actions are underway to drive increased depth of prescribing? - The focus is on helping physicians gain experience with OJEMDA and understanding the full range of patients that can benefit from it [51] Question: How should the cadence of new patient starts be viewed this year? - Steady growth is expected, with no singular inflection point anticipated [61] Question: What is the breakdown of prescriptions in Q4? - Approximately 800 prescriptions were written in Q4, with a noted increase in channel stock due to growing demand [75][80] Question: What is the differentiation of DAY301 from other PTK7 targeting ADCs? - DAY301 is believed to be a first and best-in-class opportunity, utilizing a unique payload and linker that may provide a better therapeutic index [87][101]