Day One Biopharmaceuticals, Inc.

Reported Q4 2025 U.S. Ojemda net product revenue was $52.8 million, up 37% sequentially versus Q3. Full-year 2025 net product revenue was $155.4 million, up 172% year over year, with more than 4,600 total prescriptions, up over 180% versus 2024. In FIREFLY-1 three-year data, management cited a 53% objective response rate, median response duration of 19.4 months, median time to response of 5.4 months, median progression-free survival of 16.6 months, and median time to next treatment of 42.6 months. Total cost and operating expenses were $81 million in Q4 2025 and $286 million for full-year 2025, versus $95 million and $348 million, respectively, in 2024. Cash finished 2025 at approximately $441 million net cash, with no debt. Forward guidance: 2026 Ojemda net product revenue is guided to $225 million to $250 million, gross-to-net is expected in the 16% to 19% range, and management expects full enrollment in FIREFLY-2 in the first half of 2026 with a mid-2027 top-line readout.

Jeremy Bender framed 2025 as Day One’s first full year as a commercial company and said the team proved it can both launch Ojemda and begin building a broader pipeline. He emphasized that Ojemda is moving toward second-line standard of care in pLGG, while FIREFLY-2 in frontline pLGG and the newly added EMILY program are the key next growth drivers. His tone was upbeat and confident, repeatedly pointing to strong momentum entering 2026 and the company’s “disciplined” capital base.

Charles York highlighted the company’s financial progress around Ojemda’s scale-up, noting Q4 revenue of $52.8 million, full-year revenue of $155.4 million, and double-digit sequential quarterly growth throughout 2025. He said gross-to-net stayed within the 12% to 15% range in 2025 and that total cost and operating expenses fell to $81 million in Q4 and $286 million for the year, down from $95 million and $348 million in 2024, mainly because 2024 included one-time DAY301 in-licensing expenses. He also said revenue has now exceeded the combined cost of sales and SG&A for the full year, and that the company ended 2025 with approximately $441 million in net cash and no debt, enough to fund current plans without additional financing.

Analysts focused on Ojemda persistency, the impact of the FIREFLY-1 three-year data on prescribing behavior, and how the TTNT analysis should be interpreted relative to progression and retreatment. Management said persistency is already strong, with commercial median duration of therapy trending toward 19 months, but identified opportunities to improve it further through earlier-line use, more physician experience, dose adjustment education, and greater patient support-program enrollment. On EMILY, management said the mid-year data update is intended to strengthen the evidence package for FDA discussions and a potential accelerated path in ACC, while also allowing a broader safety and efficacy update; they did not commit to specific non-ACC disclosure plans. On DAY301, management said the program is still in dose escalation and that a more comprehensive data update is expected later in 2026, but they have not yet defined the exact cohorts or expansion plan to be disclosed.