Day One Biopharmaceuticals, Inc. Q4 FY2025 earnings call

• 2025 was the first full year as a commercial company with Ojemda's launch and uptake in pLGG. - Achieved seminal commercial and clinical milestones. - Reiterated 2026 Ojemda net product revenue guidance of $225 million to $250 million. - FIREFLY-2 trial expected to complete enrollment in first half of 2026 with top-line readout in mid-2027. - Closed acquisition of Mersana in January 2026, integrating EMILY into pipeline. - DAY301 is a promising antibody-drug conjugate in development. - Ended 2025 with over $440 million in cash and no debt.

Ojemda was the primary revenue and growth driver. In 2025, net product revenue was $155.4 million, up 172% year over year. Fourth quarter net product revenue reached $52.8 million, 37% sequential growth over Q3. Full year prescriptions were over 4,600, a more than 180% growth from 2024. Ojemda contributes significantly with its efficacy and safety profile in pediatric low-grade glioma (pLGG).

• Reiterated 2026 Ojemda net product revenue guidance of $225 million to $250 million. - Expect FIREFLY-2 to complete enrollment in first half of 2026 and have top-line readout in mid-2027. - Anticipate global expansion for Ojemda in 2026 with partner Ipsen preparing for ex-U.S. regulatory approvals.

Q: How do you maintain persistency on Ojemda?

A: Identified groups like earlier-line relapsed/refractory patients, physicians with more Ojemda experience, dose-adjusted patients, and those in patient support programs as areas to focus on to drive longer persistency.

Q: With updated EMILY data coming midyear, are you looking for that to support moving into a registrational trial?

A: Will share midyear data and use it to discuss with FDA for accelerated clinical development in ACC.

Q: Early 2026 trends for Ojemda?

A: Demand strong in Q1, reiterating 2026 guidance of $225 million to $250 million.

Q: Details on TTNT analysis?

A: Analyses show Ojemda extends time to next treatment, with median TTNT 42.6 months vs median PFS 16.6 months.

Q: DAY301 data update in 2026?

A: Program in dose escalation, data update later in year with details on dose cohorts, DLTs, MTDs when available.

Q: Patient buckets for Ojemda treatment?

A: Expect persistence and durations of treatment, with potential retreatment for patients with stable tumors.

Q: EMILY response magnitude and durability in ACC?

A: Expect robust single-arm data set with sufficient objective response rate and durability for accelerated approval in ACC.