On February 25, 2025 Day One Biopharmaceuticals, Inc. (Nasdaq: DAWN) ("Day One" or the "Company"), a biopharmaceutical company dedicated to developing and commercializing targeted therapies for people of all ages with life-threatening diseases, reported its fourth quarter and full year 2024 financial results and highlighted recent corporate achievements (Press release, Day One, FEB 25, 2025, View Source [SID1234650523]).
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"The approval of OJEMDA was the catalyst for our next stage of growth and I am proud that our team was able to offer OJEMDA to so many relapsed or refractory pediatric low-grade glioma (pLGG) patients in our first months of launch," said Jeremy Bender, Ph.D., chief executive officer of Day One. "With OJEMDA as our foundation and a strong balance sheet, we believe we are on a path to long-term, durable growth and to the realization of Day One’s mission."
Program Highlights
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OJEMDA net product revenues were $29.0 million and $57.2 million for the fourth quarter and full year ended December 31, 2024, respectively.
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OJEMDA net product revenues increased 44% from the third to fourth quarter of 2024.
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In approximately eight months since launch in April 2024, more than 1,600 OJEMDA prescriptions have been written.
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OJEMDA received the Exclusively Pediatric designation by the Centers for Medicare & Medicaid Services in the fourth quarter ended December 31, 2024, reducing its Medicaid and 340B minimum rebate percentage from 23.1% to 17.1%.
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DAY301, our PTK7-targeted ADC, cleared the first dose cohort (a single-patient accelerated titration cohort) in the Phase 1a portion of the Phase 1a/b clinical trial.
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Day One advanced enrollment in the global, pivotal Phase 3 FIREFLY-2 clinical trial, with full enrollment expected in the first half of 2026.
Corporate Highlights
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Chief executive officer Dr. Jeremy Bender presented preliminary 2024 OJEMDA net product revenue and 2025 corporate priorities at the 43rd Annual J.P. Morgan Healthcare Conference. An archived audio webcast of the discussion is available by visiting the Events Presentations section of the Company’s website.
Fourth Quarter and Full Year 2024 Financial Highlights
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Product Revenue, Net: OJEMDA net product revenues were $29.0 million and $57.2 million for the fourth quarter and full year ended December 31, 2024, respectively.
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License Revenue: License revenue from the sale of ex-U.S. commercial rights for tovorafenib were $0.2 million and $73.9 million for the fourth quarter and full year ended December 31, 2024, respectively.
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R&D Expenses: Research and development expenses were $61.8 million and $227.7 million for the fourth quarter and full year ended December 31, 2024, respectively, as compared to $37.3 million and $130.5 million for the same periods in 2023. The increase was primarily due to the DAY301 upfront license payment of $55.0 million in the third quarter 2024 and initiation of the DAY301 dose escalation study milestone of $20.0 million in the fourth quarter 2024.
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SG&A Expenses: Selling, general and administrative expenses were $29.8 million and $115.5 million for the fourth quarter and full year ended December 31, 2024, respectively, as compared to $22.2 million and $75.6 million for the same periods in 2023. The increase was primarily due to employee compensation costs and professional service expenses to support the launch of OJEMDA.
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Net Loss: Net loss totaled $65.7 million and $95.5 million for the fourth quarter and full year ended December 31, 2024, respectively, with non-cash stock-based compensation expense of $11.0 million and $48.3 million for the same periods. Net loss totaled $54.5 million and $188.9 million for the fourth quarter and full year ended December 31, 2023, respectively, with non-cash stock-based compensation expense of $10.8 million and $39.3 million for the same periods.
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Cash Position: The Company’s cash, cash equivalents and short-term investments totaled $531.7 million on December 31, 2024.
Upcoming Events
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44th Annual TD Cowen Health Care Conference
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Management will participate in a fireside chat on Tuesday, March 4 at 1:10 p.m. ET. A live and archived audio webcast of the discussion will be available by visiting the Events Presentations section of the Company’s website.
Conference Call
Day One will host a conference call and webcast today, February 25 at 4:30 p.m. Eastern Time. To access the live conference call by phone, dial 877-704-4453 (domestic) or 201-389-0920 (international), and provide the access code 13745150. Live audio webcast will be accessible from the Day One Media & Investors page. To ensure a timely connection to the webcast, it is recommended that participants register at least 15 minutes prior to the scheduled start time. An archived version of the webcast will be available for replay on the Events & Presentations section of the Day One Investors & Media page for 30 days following the event.
About OJEMDA
OJEMDA (tovorafenib) is a Type II RAF kinase inhibitor of mutant BRAF V600, wild-type BRAF, and wild-type CRAF kinases.
OJEMDA is indicated for the treatment of patients 6 months of age and older with relapsed or refractory pediatric low-grade glioma (LGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation. This indication is approved under accelerated approval based on response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
Tovorafenib was granted Breakthrough Therapy and Rare Pediatric Disease designations by the FDA for the treatment of patients with pLGG harboring an activating RAF alteration, and it was evaluated by the FDA under priority review. Tovorafenib has also received Orphan Drug designation from the FDA for the treatment of malignant glioma and from the European Commission for the treatment of glioma.
For more information, please visit www.ojemda.com.