Day One Biopharmaceuticals (DAWN) Q4 2024 earnings summary

Executive summary

• OJEMDA achieved FDA accelerated approval and commercial launch in April 2024, generating $57.2M in net product revenue for the year and $29.0M in Q4, with over 1,600 cumulative prescriptions and strong compounded revenue growth.

• Ended 2024 with $531.7M in cash, cash equivalents, and short-term investments, providing a strong foundation for continued investment and growth.

• Established an ex-U.S. partnership for OJEMDA with Ipsen and recognized $73.9M in license revenue from ex-U.S. rights.

• Advanced pipeline with FIREFLY-2 trial enrollment ongoing and DAY301 program progressing through initial Phase 1a dose cohort.

• OJEMDA received Exclusively Pediatric, Breakthrough Therapy, Rare Pediatric Disease, and Orphan Drug designations, reducing Medicaid/340B rebate percentages and supporting rapid market uptake.

Financial highlights

• Total revenue for 2024 was $131.2M, including $73.9M in license revenue and $57.2M in net product revenue, up from $29.2M in 2023.

• Net product revenue for OJEMDA grew 44% sequentially from Q3 to Q4 2024, reaching $29.0M in Q4.

• Operating expenses were $343.2M for 2024, with R&D at $227.7M and SG&A at $115.5M, both up year-over-year due to commercial investments and pipeline advancement.

• Net loss narrowed to $95.5M in 2024 from $188.9M in 2023, with $48.3M in non-cash stock-based compensation.

• $108M in non-operating income was generated from the sale of a Priority Review Voucher.

Outlook and guidance

• 2025 priorities include driving OJEMDA revenue growth, advancing FIREFLY-2 and DAY301, and expanding the pipeline with first- or best-in-class opportunities.

• Guidance for OJEMDA will be provided once revenue growth and treatment duration data are more consistent.

• Full enrollment for the Phase 3 FIREFLY-2 trial is expected in the first half of 2026.

• Steady, linear growth in new patient starts is expected, with no anticipated inflection point.