Day One Biopharmaceuticals (DAWN) Q4 2024 earnings summary

Executive summary

• Achieved FDA approval and commercial launch of OJEMDA (tovorafenib) for relapsed/refractory pediatric low-grade glioma in April 2024, marking a landmark year with significant pipeline and financial progress.

• OJEMDA generated $29.0M in Q4 2024 net product revenue and $57.2M for the full year, with cumulative prescriptions exceeding 1,600 and strong compounded quarterly growth.

• Ended 2024 with $531.7M in cash, cash equivalents, and short-term investments, supporting ongoing operations and pipeline investments.

• Advanced clinical pipeline with FIREFLY II/2 phase III trial enrollment expected to complete in 1H 2026 and progress in the DAY301 ADC program.

• Established ex-U.S. partnership for OJEMDA with Ipsen and in-licensed DAY301, a clinical-stage ADC targeting PTK7.

Financial highlights

• Total 2024 revenue reached $131.2M, including $57.2M in OJEMDA net product revenue, $73.9M in license revenue, and $108.0M from sale of a Priority Review Voucher.

• Q4 net product revenue was $29.0M, up 44% from Q3, with total Q4 revenue at $29.2M including $200,000 in license revenue.

• R&D expenses rose to $227.7M in 2024, up from $130.5M in 2023, mainly due to DAY301 license and milestone payments.

• SG&A expenses increased to $115.5M in 2024 from $75.6M in 2023, driven by launch-related costs.

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

Outlook and guidance

• Priorities for 2025 include driving OJEMDA revenue growth, expanding prescriber base, and advancing pipeline enrollment.

• Guidance for OJEMDA will be provided once there is more consistency in revenue growth and treatment duration data.

• FIREFLY II/2 trial expected to complete enrollment in the first half of 2026.

• Strong cash position expected to fund operations and pipeline advancement.