Day One Biopharmaceuticals (DAWN) Q1 2025 earnings summary

Executive summary

• OJEMDA (tovorafenib) net product revenue reached $30.5 million in Q1 2025, up 11% sequentially, with over 2,500 cumulative prescriptions and strong growth driven by new patient starts and high therapy continuation rates.

• OJEMDA is being established as the standard of care in second-line plus pediatric low-grade glioma (pLGG), with FDA accelerated approval in April 2024 and EMA regulatory submission accepted in 2025.

• Ipsen licensed ex-U.S. rights to tovorafenib for $70.8M upfront, $40M equity investment, and up to $350M in milestones plus double-digit royalties.

• Pipeline includes the FIREFLY-2 confirmatory trial, Day 301 program (PTK7-targeted ADC, Phase 1a/b), and a VRK1 inhibitor in preclinical development.

• Cash, cash equivalents, and short-term investments totaled $473 million as of March 31, 2025, with no debt.

Financial highlights

• Q1 2025 net product revenue was $30.5 million, all from OJEMDA U.S. sales, with total revenue of $30.8 million including $0.3 million in license revenue.

• Operating expenses (R&D + SG&A) totaled $68.9 million in Q1 2025, including $12.9 million in non-cash stock-based compensation.

• Net loss for Q1 2025 was $36.0 million, a significant improvement from $62.4 million in Q1 2024.

• Gross margin for Q1 2025 was 91% (cost of product revenue $2.9 million on $30.5 million sales).

• Cash burn (sequential decrease in cash) was $58.7 million from December 31, 2024, to March 31, 2025.

Outlook and guidance

• Expect operating expenses to remain relatively consistent for the rest of 2025, with some quarter-to-quarter variability.

• No additional financing is projected to be needed based on current operating plans and strong cash position.

• FIREFLY-2 Phase 3 trial for front-line pLGG expected to be fully enrolled in the first half of 2026.

• Continued focus on expanding OJEMDA adoption, advancing pipeline programs, and fiscal discipline.