Short answer
Day One Biopharmaceuticals, Inc. (DAWN) filed its fiscal 2025 10-K annual report with the SEC on Feb 24, 2026. It reported revenue of $158M (+20.6% year over year) and net income of −$107M.
- Top risk flagged: Regulatory risk: Dependency on FDA approval and exclusivity for OJEMDA, with increased product revenue $155.4M driven by U.S. sales
FY2025 key financial metrics · XBRL
- Revenue
- $158M
- +20.6% YoY
- Net income
- −$107M
- −12.4% YoY
- Operating margin
- -80.8%
- +84.9 pp YoY
- EPS (diluted)
- −$1.04
- −2.0% YoY
- ROE
- -24.3%
- −5.3 pp YoY
- Operating cash flow
- −$104M
- −32.8% YoY
Source: XBRL data from the Day One Biopharmaceuticals, Inc. (DAWN) FY2025 10-K on SEC EDGAR. USD.
Day One Biopharmaceuticals, Inc. FY2025 10-K analysis
AI summary of each section, grounded in the filing text
Business Overview
- Core business: Development and commercialization of targeted oncologic therapies for pediatric and adult patients with life-threatening diseases, focusing on breakthrough medicines
- New emphasis: Commercial launch of FDA-approved OJEMDA (tovorafenib) for relapsed/refractory pediatric low-grade glioma, only once-weekly systemic pLGG therapy
- Strategic shift: Acquisition and integration of Mersana Therapeutics adding Emi-Le ADC targeting B7-H4 for adenoid cystic carcinoma, expanding oncology portfolio
- Quantitative highlight: FIREFLY-1 trial shows 53% overall response rate with OJEMDA; Phase 3 FIREFLY-2 trial ongoing with ~140 sites in 7 global regions, enrollment completion expected H1 2026
- Noteworthy fact: Ipsen License Agreement generated $70.8M upfront plus $40M equity investment; regulatory submission of tovorafenib to EMA validated, decision anticipated in 2026
Risk Factors
- Regulatory risk: Dependency on FDA approval and exclusivity for OJEMDA, with increased product revenue $155.4M driven by U.S. sales
- Macroeconomic risk: Potential impact from global economic volatility, inflation, trade barriers, and geopolitical conflicts affecting capital raising efforts
- Operational risk: Significant reliance on third-party CROs and CMOs for clinical trials and manufacturing, with $70.3M spent on tovorafenib-related outsourcing in 2025
- Competitive risk: Licensing to Ipsen for tovorafenib commercialization outside U.S. exposes company to market competition and partner execution risk
- Financial risk: Accumulated deficit $661.4M with cash $441.1M, raising capital needed through equity/debt with risk of dilution and restrictive covenants
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