Day One Biopharmaceuticals, Inc. Q2 FY2025 earnings call

• OJEMDA has exceeded expectations since its approval one year ago, with $113.1 million in cumulative net revenue over the most recent 12 months, showing strong commercial momentum, physician adoption, and patient demand.
• In Q2, OJEMDA's net product revenue was $33.6 million, and total volume exceeded 1,000 scripts for the first time. Payer coverage for OJEMDA is over 95%, and about 90% of patients receive approval upon initial submission.
• The company recently discontinued its investment in the VRK1 program, advanced the PTK7-targeted ADC DAY301 through the dose escalation portion of its Phase Ia trial, and is actively evaluating new portfolio expansion opportunities.
• Financially, the company ended Q2 with $453 million in cash and no debt, and Q2 operating expenses decreased by approximately 5% quarter-over-quarter.

In the second quarter, OJEMDA generated $33.6 million in net product revenue, which is a 10% increase over the first quarter. The trailing 12-month net revenue for OJEMDA is $113.1 million. OJEMDA contributes significantly to the company's revenue, with its strong commercial performance being the key driver.

• Day One provides full-year 2025 net product revenue guidance of between $140 million and $150 million. This guidance is based on strong and persistent demand, deepening prescriber adoption, and consistent payer coverage.
• The key variables determining where the company lands in this range are patient persistence on therapy and the pace of new patient starts.

Q: Looking at the newly provided 2025 guidance, seems second half is estimated to be around $76 million to $86 million. First half, of course, was $64 million. So what couple of levers in particular will you focus on to increase the growth rate?

A: Jeremy Bender stated that the two key variables critical to defining the revenue range for fiscal year 2025 are continued adoption in the form of new patient starts and persistence on therapy.

Q: Seeing 1,000-plus scripts in Q2, it's really great to see. So I'm wondering if you could maybe tell us what proportion of those are new versus continuing patients. And mostly, I'm asking because you mentioned the increase in new patient scripts in the latter part of Q2. So I'm wondering to what extent maybe the ASCO data might have contributed to the rash management and reversibility of the growth impacts?

A: Jeremy Bender had Lauren Merendino comment that the 2-year data has been positively received by customers, confirming efficacy and building confidence, and the growth velocity data has been reassuring, leading to an uptick in starting new patients.

Q: Jeremy or maybe, Lauren, I was just wondering if you might be willing to speak to what you're seeing with respect to durability or persistence now that you are 1 year into launch and have greater clarity there. What are you hearing from physicians regarding their intentions for how long they'd like to keep their patient on drug? And to what extent do you think the 3-year follow-up will meaningfully change their view versus the 2-year data that they've seen already?

A: Jeremy Bender had Lauren Merendino comment that many physicians intend to keep a patient on treatment for 2 years if possible, and the 3-year data will have more evidence on what happens after patients stop therapy or continue beyond 2 years, which will be informative.

Q: Continuing on previous questions, could you provide additional color on what you're modeling in your guidance in terms of new additions versus discontinuations? I'm just curious, how is your gross to net for this quarter? And separately, for the ADC DAY301, just wanted to get some understanding on how the development is progressing, what phase it is in, in terms of dose escalation? And what's the benchmark that you're looking at?

A: Charles N. York commented on the guidance assumptions including continued persistence, new patient starts, channel stock, and gross to net range remaining in 12%-15%. Michael Vasconcelles stated that DAY301 is progressing nicely through Phase I dose escalation, with an engaged group of investigators, and they'll keep an eye on benchmarks related to the PTK7 target