Day One Biopharmaceuticals, Inc. Q1 FY2025 earnings call

Key Points:

• OJEMDA achieved $30.5 million in net product revenue in Q1 2025, with 11% quarter-over-quarter growth in US net product revenue despite January seasonality.
• Cumulative US OJEMDA prescriptions reached over 2,500 since launch, with a high percentage of on-label patients continuing therapy.
• Enrollment progress in the global FIREFLY-2 confirmatory trial, expecting full enrollment in the first half of 2026 to expand OJEMDA's use into frontline pLGG.
• Ipsen's tovorafenib application accepted by the EMA for review. DAY301 is in the dose escalation phase of the Phase Ia trial.
• Company has a cash balance of $473 million with no debt, maintaining a disciplined financial strategy.

In the first quarter of 2025, OJEMDA contributed significantly to the company's revenue. OJEMDA's net product revenue was $30.5 million. Quarterly scripts increased to over 900, representing 16% growth over the prior quarter. OJEMDA is the primary product segment driving revenue, with its growth attributed to increasing prescriber adoption, on-label patient demand, and longer treatment periods.

Forward-Looking Statements:

• OJEMDA revenue growth is expected to continue due to increasing prescriber adoption, on-label patient demand, and longer treatment periods.
• FIREFLY-2 trial is expected to be fully enrolled in the first half of 2026.
• Based on current operating plans, the company does not project the need for additional financing in the future.

Risks Identified:

• Macroeconomic factors posing existential challenges and uncertainties for biotech companies.
• Seasonality impact on revenue, though programs in place to mitigate effects.
• Uncertainties regarding the duration of therapy and long-term physician adoption of OJEMDA.

Q: What are you seeing in terms of duration of therapy in the marketplace and how docs plan to use the drug long-term?

A: Lauren Merendino noted it's early to comment on duration but mentioned a very high percentage of patients continuing on therapy month after month, similar to FIREFLY-1 study trends.

Q: Could you give a rough percentage of revenue that's accounted for from new patients versus ongoing patients? Any headwinds in Q1 regarding gross to net and reimbursement?

A: Jeremy Bender and Lauren Merendino discussed that the rough percentage of on versus off-label remains around 10% off-label, 90% on label. Charles York commented on gross to net ranges of approximately 12% to 15%, with Q1 closer to the higher edge due to price increase in January and modest co-pay assistance needs.

Q: How should we be thinking about new patient starts from here and inventory levels?

A: Jeremy Bender stated new patient starts are gradual akin to a rare disease launch due to infrequent treatment decisions and disease course. Charles York mentioned channel stock is kept within a 2 to 4-week days on hand range to meet patient demand.

Q: Talk about penetration within priority centers and increasing penetration in lower accounts?

A: Lauren Merendino discussed focus on breadth and depth of prescribing, with priority one and two accounts having substantial opportunity to accelerate adoption. Elly Barry added on the conservative nature of pediatric oncologists considering long-term effects of treatments.

Q: Details on DAY301 development pipeline?

A: Jeremy Bender said DAY301 is in dose escalation in Phase 1 trial with patients in specific tumor types expressing PTK7. It's in dose escalation, with no specific timing for data but plan to move to dose expansion once safe and efficacious doses are identified.

Q: Market in Europe for tovorafenib compared to US and prescribing behavior?

A: Jeremy Bender noted similar patient populations in Europe and US, but less off-label use in Europe. Response rate is considered in evaluating efficacy in Europe similar to US.

Q: OJEMDA's positioning long-term and business development appetite?

A: Jeremy Bender discussed OJEMDA's goal to be second-line standard of care in pLGG, addressing market dynamics and entrenched use of other therapies. Charles York mentioned active business development process with high bar for evaluating opportunities to grow the business