Day One Biopharmaceuticals, Inc. Q4 FY2024 earnings call

• The FDA approved OJEMDA in 2024 for relapsed/refractory pediatric low-grade glioma, with its launch driving value creation. Full year 2024 net product revenues from OJEMDA were over $57 million.
• Advanced enrollment in the FIREFLY-2 clinical trial of tovorafenib in pediatric low-grade glioma, with the trial open at over 110 sites globally and expected to be fully enrolled in the first half of 2026.
• Established an ex-U.S. partnership for OJEMDA with Ipsen and in-licensed DAY301.
• Ended 2024 with over $500 million in cash, strengthening financial position.

For the full year 2024, net product revenues totaled more than $57 million, representing approximately eight months of sales following OJEMDA's April approval. Fourth quarter net product revenues were $29 million, which represents 44% growth versus Q3. Total revenue for the fourth quarter of 2024 was $29.2 million, comprised of $29 million in net product revenue and $200,000 of license revenue. For the full year, total revenue was $131.2 million, including $57.2 million in net product revenue from sales of OJEMDA and $73.9 million in license revenue.

• Jeremy Bender stated that guidance for OJEMDA will be determined when there's consistency in revenue growth and treatment duration, as it's still early post-launch.
• FIREFLY-2 trial is expected to be fully enrolled in the first half of 2026.

Q: When might you be in position to give guidance for OJEMDA?

A: Jeremy Bender said at this stage, the focus is on when there's consistency in revenue growth and treatment duration, as it's still quite proximal to launch.

Q: Could you speak a little bit more on the actions currently underway to drive increased depth of prescribing?

A: Lauren Merendino said focus is on physicians gaining further experience with OJEMDA, educating them on the full range of patients that can benefit, and sales team will continue to focus on Priorities 1 through 3 accounts with individualized approaches.

Q: How should we be thinking about the cadence of new patient starts this year?

A: Lauren Merendino said they've seen steady growth in new patient starts and anticipate continuing to see steady growth as the pace of the disease is different from other oncology tumor types.

Q: Wondering if you think about more second-line usage as providing a near-term benefit and creating a larger addressable pool of patients who could be on OJEMDA?

A: Lauren Merendino said it's a little of both, as earlier patients tend to be healthier with improved duration of treatment and more patients reaching that point.

Q: Any expectations around sort of what would be the gating factor to sharing any initial clinical data for DAY301?

A: Jeremy Bender said the plan is to ensure a sufficient data set is available for external understanding, and they need additional time and data from the Phase Ia portion or dose escalation portion of the trial.

Q: Could you provide an overview of DAY301 and how the product is differentiated from the other PTK7 targeting ADCs?

A: Jeremy Bender said DAY301 is a PTK7 targeted ADC with a polysarcosine linker with exatecan as a payload, drug antibody ratio of eight, and they believe it's a first and best-in-class opportunity compared to others with different payloads.

Q: On the guidance for the FIREFLY-2 enrollment, could you provide some color on what assumptions you took into account regarding the percentage of prescribers that are potentially using OJEMDA in the frontline?

A: Jeremy Bender said the projection to complete enrollment in FIREFLY-2 in the first half of 2026 is based on sites opened and enrollment rate, not influenced by off-label use in the frontline setting in the U.S.

Q: Given that this ADC targets a very unique pseudokinase, PTK7, what gives you the best conviction that using an ADC for this target is the best approach over different types of modality?

A: Jeremy Bender said conviction comes from cofetuzumab pelidotin, an auristatin-containing ADC that established proof of principle for PTK7, and DAY301's properties, including the antibody and polysarcosine exatecan payload, are expected to lead to a better therapeutic index.