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Day One Biopharmaceuticals (DAWN) investor relations material
Day One Biopharmaceuticals Q2 2025 earnings summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.
Executive summary
OJEMDA net product revenue reached $33.6M in Q2 2025, up 310% year-over-year and 10% sequentially, with over 1,000 prescriptions and strong commercial momentum.
FDA approved OJEMDA in April 2024 for relapsed/refractory pLGG; commercial launch underway in the U.S.
Cumulative net revenue for the trailing twelve months reached $113.1M, surpassing initial launch expectations.
Entered Ipsen License Agreement for ex-U.S. commercialization, with $70.8M upfront, $40M equity investment, and EMA submission planned for Q1 2025.
Ended Q2 2025 with $453.1M in cash, cash equivalents, and short-term investments, and no debt.
Financial highlights
Q2 2025 net product revenue was $33.6M, up 10% sequentially and 310% year-over-year.
Year-to-date net product revenue reached $64.1M; trailing twelve-month revenue totaled $113.1M.
Q2 2025 total operating expenses were $68.9M, including $36.1M R&D and $29.0M SG&A, both down year-over-year.
Net loss for Q2 2025 was $30.3M, compared to $4.4M in Q2 2024, which included a $108M gain from a priority voucher sale.
Cash, cash equivalents, and short-term investments totaled $453.1M as of June 30, 2025.
Outlook and guidance
Full-year 2025 OJEMDA net product revenue is projected at $140M–$150M, implying about 150% year-over-year growth at the midpoint.
Patient enrollment for the pivotal Phase 3 FIREFLY-2 trial is on track for completion in H1 2026; three-year follow-up data from FIREFLY-1 expected in Q4 2025.
Guidance assumes steady increase in new patient starts and persistence on therapy; gross-to-net range expected at 12%–15%.
EMA regulatory submission for OJEMDA expected in Q1 2025; eligible for up to $380M in milestones and double-digit royalties from Ipsen.
Cash position expected to fund operations for at least 12 months from filing date.
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