Day One Biopharmaceuticals (DAWN) Q3 2024 earnings summary

Executive summary

• Achieved $20.1M in OJEMDA net product revenue in Q3 2024, more than doubling from the previous quarter, with 159% prescription growth and strong payer coverage rates.

• OJEMDA (tovorafenib) received FDA accelerated approval in April 2024 for relapsed/refractory pediatric low-grade glioma (pLGG) with BRAF alterations, marking the first commercial product launch.

• Entered exclusive ex-U.S. licensing agreement with Ipsen in July 2024, securing $70.8M upfront, $40M equity investment, and potential for up to $350M in milestones and royalties.

• Net income of $37.0M for Q3 2024, compared to a net loss of $46.2M in Q3 2023.

• Strong financial position with $558.4M in cash, cash equivalents, and short-term investments at quarter end.

Financial highlights

• Q3 2024 total revenue: $93.8M, including $20.1M in OJEMDA net product revenue and $73.7M in license revenue from Ipsen.

• Operating expenses for Q3 2024 were $64.1M, up from $51.4M in Q3 2023, mainly due to commercial and R&D investments.

• R&D expenses for Q3 2024: $33.6M; SG&A expenses: $29.0M.

• Net income per share (basic and diluted) was $0.38 in Q3 2024, compared to $(0.54) in Q3 2023.

• Non-operating income for nine months ended 9/30/24 includes $108M from sale of Priority Review Voucher.

Outlook and guidance

• Focused on expanding OJEMDA's prescriber base, payer coverage, and establishing it as standard of care in 2nd line pLGG.

• Pivotal Phase 3 FIREFLY-2 trial for tovorafenib as front-line pLGG therapy continues global enrollment at over 100 sites.

• DAY301 (PTK7-targeted ADC) Phase 1 trial expected to begin dosing in Q4 2024 or early Q1 2025.

• Cash position expected to fund operations for at least twelve months from the filing date.

• No specific guidance on timing of DAY301 data release in 2025.