Day One Biopharmaceuticals Q3 2025 Earnings Report

Day One Biopharmaceuticals EPS Results

• Actual EPS: -$0.19
• Consensus EPS: -$0.28
• Beat/Miss: Beat by +$0.09
• One Year Ago EPS: $0.38

Day One Biopharmaceuticals Revenue Results

• Actual Revenue: $39.80 million
• Expected Revenue: $38.20 million
• Beat/Miss: Beat by +$1.59 million
• YoY Revenue Growth: -57.60%

Day One Biopharmaceuticals Announcement Details

• Quarter: Q3 2025
• Date: 11/4/2025
• Time: After Market Closes
• Conference Call Date: Tuesday, November 4, 2025
• Conference Call Time: 4:30PM ET

Day One Biopharmaceuticals (NASDAQ:DAWN) (NASDAQ: DAWN) is a clinical-stage biopharmaceutical company focused on the discovery and development of targeted therapies for oncology. The company employs a precision medicine approach, leveraging biomarker-driven strategies to identify patient populations most likely to respond to its investigational compounds. By concentrating on well-validated molecular drivers of cancer, Day One seeks to deliver first-in-class or best-in-class therapies with the potential for meaningful clinical benefit.

The company’s pipeline includes several small-molecule candidates in various stages of development. The lead program, D1-B701, is a selective FGFR4 inhibitor designed to treat FGF19-driven hepatocellular carcinoma and other solid tumors. Additional programs include D1-H201, a selective HDAC6 inhibitor for certain hematologic malignancies, and D1-R199, a RET kinase inhibitor targeting RET fusion-positive cancers. Each program is supported by companion diagnostic strategies aimed at enriching patient populations and optimizing clinical outcomes.

Founded in 2017, Day One Biopharmaceuticals is headquartered in San Diego, California, and maintains research and development operations in both the United States and Asia. The company’s leadership team comprises professionals with extensive experience in oncology drug discovery, clinical development, regulatory affairs and commercial strategy. Day One collaborates with academic and industry partners to advance its pipeline and remains committed to addressing significant unmet needs in cancer therapeutics through scientifically rigorous and patient-focused innovation.

Day One Biopharmaceuticals Q3 2025 Earnings Call Transcript

Key Takeaways

• Positive Sentiment: Q3 commercial momentum was strong: $38.5M net product revenue (up 15% Q/Q), total prescriptions +18% and new patient starts ~20%, leading Day One to raise full‑year 2025 guidance to $145–$150M.
• Positive Sentiment: Regulatory/clinical profile strengthened as the FIREFLY‑1 two‑year data were added to the OJEMDA label — showing manageable safety, reversible growth‑velocity decreases and an increased median duration of response — with three‑year data to be presented at SNO later this month.
• Positive Sentiment: Commercial durability and access look supportive of recurring revenue: U.S. EAP patients show a median treatment duration of ~20 months (75% continued past 24 months) and ~90% of PLGG patients receive payer approval on first submission.
• Positive Sentiment: Financial discipline visible — Q3 revenue exceeded the combined cost of sales and SG&A for the first time, operating expenses fell ~9% Q/Q, and the company ended the quarter with $451.6M cash and no debt, though management is not yet guiding to profitability.
• Neutral Sentiment: Pipeline and market risks: Ipsen expects an EMA decision mid‑2026, FIREFLY‑2 remains on track for full enrollment H1‑2026 and DAY‑301 dose escalation continues, but non‑EAP commercial persistence data are still maturing and a July price increase temporarily pushed gross‑to‑net toward the high end of guidance.

Presentation

[Operator]

Hello, ladies and gentlemen, and welcome to Day One Biopharmaceuticals' third quarter 2025 financial and operating results conference call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session. Please be advised that this conference call is being recorded. I would now like to turn the call over to your host, Joey Perrone, Senior Vice President of Finance and Investor Relations. Thank you. You may begin.

[Joey Perrone, SVP of Finance and Investor Relations at Day One Biopharmaceuticals]

Thank you. Hello, everyone, and good afternoon. Welcome to Day One's third quarter financial and operating results conference call. Earlier today, we issued a press release that outlines the topics we plan to discuss today. You can access the press release and the slides to accompany this conference call on the Investors and Media section of our website at www.dayonebio.com. An audio webcast with the corresponding slides is also available on the website. Before we get started, I'd like to remind everyone that some of the statements that we make on this call and information presented in the slide deck include forward-looking statements as outlined on slide two. Actual events and results could differ materially from those expressed or implied by any forward-looking statements.

[Joey Perrone, SVP of Finance and Investor Relations at Day One Biopharmaceuticals]

We encourage you to review the various risks, uncertainties, and other factors included in our most recent filings with the SEC and any other future filings that we make with the SEC. These forward-looking statements are based on our current estimates and various assumptions and reflect management's intentions, beliefs, and expectations about future events, strategies, competition, products and product candidates, operating plans, and performance. You are cautioned not to place any undue reliance on these forward-looking statements, and except as required by law, Day One Biopharmaceuticals disclaims any obligation to update such statements. Today, I'm joined by Dr. Jeremy Bender, Chief Executive Officer, Lauren Merendino, Chief Commercial Officer, Charles York, Chief Operating and Financial Officer, and Michael Vasconcelles, Head of Research and Development. I will now turn the call over to Jeremy.

[Jeremy Bender, CEO at Day One Biopharmaceuticals]

Thank you, Joey. Good afternoon, and thank you all for joining us. Q3 was an outstanding quarter for Day One Biopharmaceuticals. We accelerated growth across every key dimension of OJEMDA's performance: new patient starts, total prescriptions, and net product revenue. Our early launch momentum and execution have led to steady and sustainable gains quarter-over-quarter, reflecting continued performance across the organization and growing confidence in OJEMDA's differentiated profile among the members of the pLGG prescribing community. In Q3, we delivered $38.5 million in net product revenue, representing a 15% quarter-over-quarter increase, our strongest quarter for both total revenue and sequential growth so far in 2025. This performance reflects not only increased adoption but also significant and durable treatment persistence, which we'll elaborate on further in a moment. The two-year FIREFLY-1 data, which are now included in the OJEMDA label, continue to demonstrate a manageable safety profile and durable clinical benefit.

[Jeremy Bender, CEO at Day One Biopharmaceuticals]

The two-year analysis demonstrated that growth velocity decreases resulting from OJEMDA treatment are reversible, with nearly all patients demonstrating catch-up growth post-treatment. The median duration of response to OJEMDA in this two-year analysis also increased from 13 to 18 months. Three-year FIREFLY-1 data will be presented later this month at an oral presentation at the Society for Neuro-Oncology annual meeting, followed by a full manuscript we expect will be published in the first half of next year. With durable demand, expanding physician experience, and disciplined execution, OJEMDA is well-positioned to build on its strong trajectory. With the strength we've seen across key performance drivers and improved visibility into year-end, we're raising the low end of our full-year revenue guidance to a new range of $145-$150 million for 2025. This new guidance underscores our confidence in the trajectory of OJEMDA's launch and the durability of its growth story.

[Jeremy Bender, CEO at Day One Biopharmaceuticals]

Our pipeline also continues to advance. Our partner, Ipsen, anticipates a mid-2026 EMA approval decision, marking a key step toward bringing OJEMDA to patients in Europe. FIREFLY-2, our global phase III trial, remains on track for full enrollment in the first half of 2026, positioning OJEMDA to potentially move into frontline pLGG in the U.S. And Day 301, our PTK7-directed ADC, continues to advance, with dose escalation ongoing in the phase I-A trial. Separately, Tovorafenib was added to the National Comprehensive Cancer Network adult glioma treatment guidelines as a Category 2A recommended treatment option for patients with recurrent or progressive BRAF-altered disease. Altogether, these milestones highlight both depth and momentum across our portfolio and reinforce Day One Biopharmaceuticals' value creation trajectory. As we look to the end of 2025, our priorities are clear. First, drive adoption of OJEMDA as standard of care in second-line pLGG. Second, continue to advance our pipeline.

[Jeremy Bender, CEO at Day One Biopharmaceuticals]

And third, maintain disciplined expense management to keep us firmly on the path to profitability. Our results this quarter strengthen our confidence in Day One Biopharmaceuticals' near-term and long-term financial and pipeline performance. The team remains energized by our progress and focused on continuing to deliver meaningful value for patients, providers, and shareholders. With that, I'll now hand it over to Lauren, who will provide further insight into our commercial performance.

[Lauren Merendino, Chief Commercial Officer at Day One Biopharmaceuticals]

Thanks, Jeremy, and good afternoon, everyone. Q3 was our strongest quarter since launch, with impressive double-digit acceleration across all key parameters of our business. Net product revenue rose 15% to $38.5 million for the quarter. Total prescriptions grew by 18%, with over 1,200 total prescriptions. And new patient starts accelerated by almost 20% quarter-over-quarter. These results underscore the continuing momentum with this brand. Let's take a closer look at what drove our business this quarter. We've driven double-digit growth quarter-over-quarter for the five consecutive quarters since launch. In the first three quarters of this year, we delivered over $102 million in net product revenue, reflecting an 89% increase over full year 2024. This is driven by underlying patient demand reflected in our prescription trends, which you can see on the next slide. Since launch, we have continued to drive an increase in total prescriptions each quarter.

[Lauren Merendino, Chief Commercial Officer at Day One Biopharmaceuticals]

In Q3, this accelerated to 18% with over 1,200 total prescriptions and was fueled by three main drivers. First, an acceleration in new patient starts. The release of the two-year follow-up data from FIREFLY-1 meaningfully enhanced physician confidence in OJEMDA's durable efficacy. We have also demonstrated that the large majority of growth velocity delays are reversible following treatment. Physician feedback on the data has been strongly positive, and we believe these data contributed to achieving our highest-ever new patient starts this quarter. We've also seen increased adoption in the second line, confirming the increasing confidence in our brand. The second important driver is persistency. A high percentage of pLGG patients stay on therapy each month, building our active patient pool over time. The experience of our EAP patients is an important leading indicator here, and we have some learnings on their persistence that I'll share in a moment.

[Lauren Merendino, Chief Commercial Officer at Day One Biopharmaceuticals]

The third driver of our success has been OJEMDA's excellent payer access. About 90% of pLGG patients are receiving payer approval on their first request, enabling rapid initiation post-prescription for most patients. Let's look a little deeper at some of these dynamics. Over time, as physicians have gained experience with OJEMDA, we've seen increased adoption in the second line. Second-line adoption grew more than 60% over the past 12 months based on physicians' self-reported prescribing behavior. Additionally, through our engagements, we are hearing more and more physicians reporting that OJEMDA is their treatment of choice in the second line. Here you can see a couple of quotes from our physicians who attended a recent advisory board.

[Lauren Merendino, Chief Commercial Officer at Day One Biopharmaceuticals]

One stating that OJEMDA is their treatment of choice in the second line, and the other stating they recently changed their treatment paradigm to use OJEMDA in the second line as the first targeted therapy after a patient fails chemotherapy. Though this is encouraging progress, considerable opportunity remains for continued adoption of OJEMDA as it becomes the standard of care in second line. While the persistency data for our commercial new patient starts is still maturing, our EAP cohort is a helpful leading indicator, as you can see on the right-hand side of this slide. These patients are further along in their treatment, offering a longer-term view. U.S. EAP patients had a median duration of treatment of 20 months, which is consistent with what we expected based on our FIREFLY-1 trial results.

[Lauren Merendino, Chief Commercial Officer at Day One Biopharmaceuticals]

Additionally, we've seen that for those EAP patients who have completed 24 months on OJEMDA, three-quarters of them received treatment beyond 24 months. While EAP patients have provided valuable insights, they currently represent a small fraction of our business today. In fact, commercial new patient starts now account for roughly 90% of our active patients at the end of Q3. Another pillar of our growth has been expanding both breadth and depth of our prescribing base. The graph on this slide demonstrates the increase we've seen in both breadth and depth over time based on commercial new patient starts only, excluding EAP patients. The upper line of the graph represents breadth and shows a continuing growth trajectory in the number of accounts prescribing OJEMDA.

[Lauren Merendino, Chief Commercial Officer at Day One Biopharmaceuticals]

While all of our priority one accounts and the large majority of our priority two accounts have already prescribed, we continue to drive breadth by gaining new prescribing accounts in our priority three group. The layers of the graph show depth. Over 60% of prescribing accounts have treated multiple patients with OJEMDA. Notably, the number of accounts treating four or more patients grew 28% quarter-over-quarter, and over 80% of our priority one accounts have now treated four or more patients. You'll also notice that we've added a new layer since last quarter to represent those accounts with nine or more patients. This, combined with the other insights from this graph, continue to show the progress we're making in the depth of prescribing and establishing OJEMDA as a trusted treatment for relapsed or refractory pLGG patients. We are excited about the substantial opportunity which remains for OJEMDA.

[Lauren Merendino, Chief Commercial Officer at Day One Biopharmaceuticals]

Our commercial team continues to focus on two principal levers. Driving new patient starts and optimizing persistence. Through disciplined execution against these priorities, we are confident that we will continue to yield double-digit growth over time. I'm incredibly proud of what the commercial team has delivered since launch, and especially this quarter. It shows that we execute with excellence across all facets of commercial and continue to deliver for our customers and, most importantly, for pLGG patients. To better reflect this momentum, we are raising our guidance range to $145-$150 million for 2025. Our clinical and medical teams continue to deliver compelling data and analyses that enhance the OJEMDA product profile, providing new insights to physicians on what to expect with OJEMDA.

[Lauren Merendino, Chief Commercial Officer at Day One Biopharmaceuticals]

This quarter, the FIREFLY-1 two-year follow-up data was an accelerator for our brand, leading to increases in confidence from prescribers with a meaningful step-up in new patient starts and overall growth for the quarter. This is an important step forward in building our product profile with long-term data. Later this month, the three-year follow-up data for FIREFLY-1 will be an oral presentation at the Society for Neuro-Oncology annual meeting with a peer-reviewed journal publication planned for next year. These data will provide a longer-term view of safety and efficacy with OJEMDA and also highlight patients' journeys after completing their initial course of therapy. Data reporting time to next treatment and treatment-free interval will be important potential differentiators for physicians in the care of their patients.

[Lauren Merendino, Chief Commercial Officer at Day One Biopharmaceuticals]

Through continuing to build OJEMDA's clinical profile and excellence in commercial execution, we are confident that we will establish OJEMDA as the new standard of care in second-line BRAF-altered pLGG. I'll now hand it over to Charles to provide an update on our financial performance.

[Charles York, COO and CFO at Day One Biopharmaceuticals]

Earlier today, we reported our Q3 2025 financial results. For today's call, I'll highlight a few key takeaways that demonstrate the strong commercial execution and durable growth trajectory of OJEMDA, along with our continued focus on financial discipline and operational excellence. We're very pleased with the progress we've made this year. Following OJEMDA's April 2024 approval, momentum continues to build, fueled by growing physician confidence and compelling longer-term follow-up data from our FIREFLY-1 study. These results are translating directly into performance, with double-digit growth across revenue, prescriptions, and new patient starts this quarter. These are all great indicators for continued momentum ahead. For Q3, U.S. OJEMDA net product revenue was $38.5 million, which grew 15% compared to the second quarter. Our Q3 results bring our year-to-date net product revenue to $102.6 million.

[Charles York, COO and CFO at Day One Biopharmaceuticals]

Additionally, revenue from OJEMDA exceeded the combined cost of sales and SG&A for the first time this quarter, highlighting both its growing contribution to the enterprise and the scalability of our operating model. Based on the continued strength of underlying demand and improved visibility into Q4, we are raising our full year 2025 revenue guidance to a new range of $145-$150 million. This revised range reflects our confidence in the trajectory of the launch and assumes continued double-digit sequential growth in the fourth quarter. Turning now to expenses, we continue to manage operating costs effectively, with total operating expenses of $59.6 million, which includes $9.6 million of non-cash stock-based compensation. This is the second consecutive quarter with declining expenses, approximately 9% compared to Q2. This continued trend reflects our data-driven approach to capital allocation.

[Charles York, COO and CFO at Day One Biopharmaceuticals]

We prioritize investment in the areas with the highest potential return and intentionally scale back where we don't see a clear path to value creation. That said, we do expect Q4 expenses to increase modestly, reflecting the timing of planned commercial and clinical activities. We believe these are the right investments to support sustained growth in 2026 and beyond. We also continue to closely manage channel stock levels to align with demand. Historically, we've guided to maintaining approximately two to four weeks of product on hand. In this quarter, we finished at the lower end of the range. This reflects timing of orders and growing demand for OJEMDA rather than any supply constraints, and we'll continue to actively monitor channel stock to ensure unconstrained product availability for our patients. On gross-to-net, we continue to guide to a range of 12%-15% for the year.

[Charles York, COO and CFO at Day One Biopharmaceuticals]

Due to the price increase we implemented in July, we're at the high end of that range for this quarter, which reflects short-term increases in Medicaid rebates that occur after a price change. We ended the quarter with $451.6 million in cash and no debt, reflecting only a slight decrease from the prior quarter as we continue to invest in advancing our commercial and pipeline priorities. With strong revenue growth translating into higher cash flows and expenses holding relatively steady, we are seeing continued improvement in quarterly net cash burn. While we are not guiding to profitability, maintaining financial discipline and advancing long-term value creation remain top priorities for the organization. Finally, business development remains a key strategic priority for future growth. We continue to actively evaluate opportunities that complement our commercial capabilities and our long-term strategy.

[Charles York, COO and CFO at Day One Biopharmaceuticals]

Our approach remains focused on identifying assets where we can create meaningful value through development or commercialization expertise. Overall, Q3 represents another strong step forward. Both commercially and operationally. With accelerating demand, expanding prescriber depth, and important upcoming data disclosures, we believe the foundation we've built positions us well for advancing our long-term objectives. I'll now hand it back to the operator for Q&A.

[Operator]

Thank you. At this time, we'll be conducting a question-and-answer session. If you'd like to ask a question, please press Star One on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press Star Two if you'd like to remove your question from the queue. We ask that you please limit to one question and one follow-up. One moment, please, while we poll for questions. Our first question comes from Tara Bancroft with TD Cowen. Please proceed with your question.

[Tara Bancroft, Director of Biotech Equity Research and Senior Analyst at TD Securities]

So I guess I'm curious to what extent you could possibly describe, even qualitatively, what impact you're seeing on both the rate of discontinuations and duration of therapy, especially in non-EAP patients, now that physicians have had a good amount of exposure this year to various data sets. I know previously you had mentioned that some proportion of discontinuations were driven by off-label use and settings with lower duration and also improper treatment of rash. So just curious to get an update here, considering that you saw a really great level of increased demand this quarter that was driven mostly by that data.

[Jeremy Bender, CEO at Day One Biopharmaceuticals]

Hi, Tara. Thanks for the question. This is Jeremy. So first off, it was a great quarter. I think you captured it appropriately. And that was really on both the new patient start dimension, but also the persistence, as noted. So let me ask Lauren to comment on the sort of non-EAP commercial use group.

[Lauren Merendino, Chief Commercial Officer at Day One Biopharmaceuticals]

Yeah. Thanks, Tara, for the question. At this point, the data is still maturing on our commercial patients. So what I can say is it's consistent with our expectations, but I really can't give any details beyond that. But I do think that the median duration of therapy in the EAP patients of 20 months is significant and is a leading indicator for us. That data is not final. There still are a number of patients who remain on therapy who have not yet reached the point of receiving OJEMDA for 24 months yet. So that number may evolve, but the median will likely stay the same, but the additional duration beyond 24 months is an evolving data point.

[Jeremy Bender, CEO at Day One Biopharmaceuticals]

Yeah. And Tara, I would really emphasize that latter point because it's very much what we expected and hoped we would see for patients. And that is that for those patients that have tumors where small changes in the growth can impact function. It makes sense to keep them on therapy. And we're seeing that in the real world through the EAP program to date. For the non-EAP commercial group, it really is just too early to say at this stage.

[Tara Bancroft, Director of Biotech Equity Research and Senior Analyst at TD Securities]

Okay. That makes so much sense. Very helpful. Thanks so much.

[Jeremy Bender, CEO at Day One Biopharmaceuticals]

Thank you.

[Operator]

Our next question comes from Anupam Rama with JPMorgan. Please proceed with your question.

[Anupam Rama, Stock Analyst at JPMorgan]

Hey, guys. Thanks so much for taking the question. I just wanted to focus a little bit on the three-year data for pivotal FIREFLY-1 study that's coming out at SNO later this month. Can you just expand a little bit more on what you're looking for in that data that could inform how we think about treatment duration or other commercial levers for OJEMDA moving forward? Thanks so much.

[Jeremy Bender, CEO at Day One Biopharmaceuticals]

Thanks for the question, Anupam. Mike will answer that one for you. Mike?

[Michael Vasconcelles, Head of Research and Development at Day One Biopharmaceuticals]

Thanks, Jeremy. Hi, everyone. Mike Vasconcelles here. Yeah. We're really excited about these data coming up at SNO. I think given the nature of the disease, the long-term follow-up data in our clinical development program is going to be important for a variety of reasons for the foreseeable future. So of course, in addition to an update on safety and duration of response, I think what's going to be important to keep an eye out for are the time-to-event analyses that will be shared specifically around the time to next treatment and the treatment-free interval as well as progression.

[Michael Vasconcelles, Head of Research and Development at Day One Biopharmaceuticals]

The reason that's important is because it'll be important in second and subsequent lines of therapy to really understand that in the context of other available therapies where we know there may be some biologic sort of events that occur when patients come off therapy that we'll want to see if are going to be distinguishable for OJEMDA. I think we'll also get a sense of perhaps early retreatment information that could be meaningful for clinicians and patients.

[Jeremy Bender, CEO at Day One Biopharmaceuticals]

Thanks. And what I would focus on within the category of events that happen off treatment for other therapies is really that there is, to kind of add to Mike's answer, some rebound growth that physicians observe with use of MEK inhibitors in particular when patients come off therapy. That's rebound tumor growth. So we'll be looking at that as part of the three-year analysis as well as those time-to-event points that Mike mentioned.

[Anupam Rama, Stock Analyst at JPMorgan]

Thanks so much for taking the question.

[Jeremy Bender, CEO at Day One Biopharmaceuticals]

Thanks, Anupam.

[Operator]

Our next question comes from Andrea Newkirk with Goldman Sachs. Please proceed with your question.

[Morgan Lamberti, Equity Research Associate at Goldman Sachs]

Hi. This is Morgan on for Andrea Newkirk. Thank you for taking our question. Can you speak to how the addition of the FIREFLY data to the label has impacted rates of off-label MEK inhibitor usage? And then on the payer side, you noted 90%-plus rates of coverage approval on first submission. Is there a reason to think that favorable coverage could impact the rates of off-label MEK inhibitor usage as well? Thank you.

[Jeremy Bender, CEO at Day One Biopharmaceuticals]

f

[Morgan Lamberti, Equity Research Associate at Goldman Sachs]

Yeah.

[Jeremy Bender, CEO at Day One Biopharmaceuticals]

Okay. Yeah. I'd say, first off, we weren't aware that that was a listing that was going to occur. And of course, we're interested. We think there's some potential utility there based on data that we've seen in the past for OJEMDA. It's a little early to say whether or not it will have any material impact on off-label use, but it certainly could, given that, in particular, in adult settings, those NCCN listings can be influential as far as physicians electing to try treatments that are not necessarily approved for a specific tumor. So I think it's a stay-tuned story. And Lauren can comment on your question around reimbursement.

[Lauren Merendino, Chief Commercial Officer at Day One Biopharmaceuticals]

Yeah. So just remember that. NCCN is an independent organization. And so although they've made their recommendation, that is not reflected in our label in any way. And so the commercial team must remain strictly within our label. So we have no ability to engage with physicians on that topic at all. But I will say that payers do sometimes leverage NCCN guidelines to inform their policies. But again, this is nothing that we can participate in, and that would be completely up to those payers.

[Jeremy Bender, CEO at Day One Biopharmaceuticals]

Yeah. And I would add that our rates of reimbursement for both on-label and off-label have been so high already that I'm not sure that reimbursement has been a barrier to use. So it's probably more likely to be a circumstance where the recommendation itself could lead to use based on physician decision-making that's really outside of our control.

[Morgan Lamberti, Equity Research Associate at Goldman Sachs]

Okay. That's helpful. Thank you.

[Jeremy Bender, CEO at Day One Biopharmaceuticals]

Thank you, Morgan.

[Operator]

Our next question comes from Alec Stranahan with Bank of America. Please proceed with your question.

[Alec Stranahan, VP of Equity Research at Bank of America]

Hey, guys. Thanks for taking our questions and congrats on the strong quarter. Two from us. Curious if you saw any gross-to-net changes in 3Q. Just trying to pair the different growth rates that you mentioned, both on revenues and scripts. And then second, on DAY 301, I guess, how has enrollment been going? Is it sort of proceeding as you would have expected? And any updated thoughts on PTK7 as a target, given the shifting development landscape for ADCs against the target? Thank you.

[Jeremy Bender, CEO at Day One Biopharmaceuticals]

Alec, thanks for the question and comment. Let me ask Charles to comment on gross-to-nets and then Mike regarding 301 and PTK7.

[Charles York, COO and CFO at Day One Biopharmaceuticals]

Hey, Alec. This is Charles. So on the gross-to-nets, you should hear from us that we were definitely at the high end of our 12%-15% range that we've guided on. That's consistent with what we expected going into the quarter. As you recall from previous conversations, we did take a price increase as of July 1st, and the result of that is a CPIU penalty, which does drive up our gross-to-net rates. We would expect in Q4 to get some relief on that CPIU. That's pretty consistent with what we've seen in previous quarters, but we were definitely at the high end for this quarter.

[Michael Vasconcelles, Head of Research and Development at Day One Biopharmaceuticals]

Hi again. This is Mike. With respect to the DAY 301 program, we have a great group of investigators, and the DAY 301 program continues to move along nicely through not just dose escalation, but also the beginning of dose optimization and backfill cohorts. Really no issues whatsoever there. With respect to your broader question, I think I'd reframe it just a bit. I'm not so certain there's an issue at all with the target. In fact, I think the target is a really sound target for oncology development. There are distinctions between some of the other therapeutics against the target, especially with respect to payload, but we're focused, obviously, on our own program, which continues to progress nicely through its paces in early development.

[Alec Stranahan, VP of Equity Research at Bank of America]

Okay. Thank you very much.

[Charles York, COO and CFO at Day One Biopharmaceuticals]

Hey, Alec, one more statement too, as I was reflecting on the greater portion of your question. One of the key things to remember too, in addition to the gross-to-net and trying to get to where I believe you're getting in your calculation, is where we are with channel stock on hand during the quarter as well. For this quarter, we were at the low end of our channel stock range. That was really a result of the timing of when shipments occur and where the calendar fell, to be fair. But it was really driven by a high level of demand this quarter, given the high level of NPS and the strong duration that we have. But when you're thinking through your calculation, definitely consider the low end of that range being there. We'll continue that two to four weeks of days on hand going forward.

[Charles York, COO and CFO at Day One Biopharmaceuticals]

We are continuing that with the guidance and internally working on that. But note that we are at the low end.

[Alec Stranahan, VP of Equity Research at Bank of America]

Okay. Very helpful, caller. Thank you.

[Jeremy Bender, CEO at Day One Biopharmaceuticals]

Thanks, Alec.

[Operator]

Our next question is from Kelsey Goodwin with Piper Sandler. Please proceed with your question.

[Kelsey Goodwin, Senior Research Analyst at Piper Sandler]

Oh, hey. Thanks for taking our question and congrats on the quarter. Two from me. First, maybe just any commentary that you could provide in terms of how the patient population breaks down in terms of line of therapy. I know you had some commentary on increases in second line specifically, but any color there? And then second question, in terms of gaining uptake with a particular physician, how impactful do you think having the longer-term data is, for example, the ASCO data sets versus the prescriber just gaining that firsthand experience? Thanks so much.

[Jeremy Bender, CEO at Day One Biopharmaceuticals]

Thanks for the questions, Kelsey. Good ones that I'll ask Lauren to respond to.

[Lauren Merendino, Chief Commercial Officer at Day One Biopharmaceuticals]

Yes. Thank you for the questions. So from a line of therapy perspective, first, let me just say that from a primary data perspective, our view is limited. So we don't have a comprehensive data set to look at line of therapy. It's just the nature of our data. So we have to get it from other angles. And the way that we do that is through market research with physicians. So the data that I reported today was from self-reported physician prescribing behavior. And we have seen this over time, so over the past 12 months, increase significantly in what they are reporting as far as using OJEMDA in the second line. So we've seen about 60% growth in their reporting of that. But that's the best data that we have at this point. And so that's the lens that we look at line of therapy through.

[Lauren Merendino, Chief Commercial Officer at Day One Biopharmaceuticals]

To your question about uptake, it's very hard to split kind of physician behavior into the why they did that. So you were asking what's long-term data versus firsthand experience. I think it's always a combination of both. But when we're talking about the latest data that came out, the one that I wanted to mention, not to underestimate, is the ASCO data that was reported on growth velocity. So I do think that some physicians, although they may have believed in the efficacy, and I don't think that most of them were surprised by our efficacy update, it was consistent with what they expected, I do think that some of them may have been more cautious in using OJEMDA than even they would admit. Because they had unanswered questions about growth velocity. That ASCO data set answered those questions. So it showed reversibility in the large majority of patients.

[Lauren Merendino, Chief Commercial Officer at Day One Biopharmaceuticals]

And many of the physicians who saw that data reported to us that that was meaningful to them and that that really made them more confident in using OJEMDA in their patients. Did that answer your question?

[Kelsey Goodwin, Senior Research Analyst at Piper Sandler]

Yep. That's perfect. Thank you so much.

[Jeremy Bender, CEO at Day One Biopharmaceuticals]

Thanks, Kelsey.

[Operator]

Our next question comes from Ami Fadia with Needham & Company. Please proceed with your question.

[Ami Fadia, Senior Analyst at Needham & Company]

Hi. Good afternoon. Thanks for taking my question and congrats on the nice quarter. My question is about the three-year update that's coming up. And I heard sort of your remarks about at least in the EAP patients, you're seeing sort of a median of about 20 months of duration of use. With the three-year update coming up, do you think are you expecting to see some patients sort of that median go up in that study? Or is it more meant to inform when to restart treatment and inform growth velocity while the patient is sort of off treatment? So help us understand sort of what we should be focusing on when we see that data. And then separately, if I may. I can stop and ask a second question later.

[Jeremy Bender, CEO at Day One Biopharmaceuticals]

No problem, Ami. Thanks for the question. So let me walk you through what we know today already from the FIREFLY-1 study and then what we're expecting from the three-year data. And I'll ask Mike to add anything to my comments. So in the trial FIREFLY-1, we know already that the median duration of treatment was just under 24 months. And we've known that for some time. And that's an important data point that actually informed our expectation around what we may see as a median in the commercial setting. We're not there yet in the commercial setting, but we are for that EAP component. And that's why we reported out that 20-month median for the EAP cohort. And that's highly consistent with our expectations and benchmarks. So really encouraging.

[Jeremy Bender, CEO at Day One Biopharmaceuticals]

For the three-year data set, we're really focused on what happens as you follow patients out for longer periods of time. In particular, what we're focused on, as Mike noted earlier, are these time-to-event kind of endpoints. But to make it really simple, what we're really laser-pointed on is what physicians have been asking us, which is, what happens after you give patients 24 months of therapy of OJEMDA once they come off treatment? And they can come off for a bunch of reasons. It can be they simply want a break. It could be some focus on releasing that growth velocity delay. But regardless, in this physician community and in this patient population, there's always a desire to limit treatment if it's at all possible.

[Jeremy Bender, CEO at Day One Biopharmaceuticals]

And their specific question for us, there really are two, has been, one, do you see tumor rebound growth, meaning short-term increases in the tumor growth right after you stop that therapy after 24 months? And the reason they're focused on that question is because of their observations reported to us. This is not published, but their own observations around what happens with MEK inhibitor treatment when you stop MEK inhibitor treatments. That's the first question that they're interested in. The second is independent of that growth rebound, do you also see stability of the tumor for a significant period of time after that 24-month treatment period? And the way they think about that is what do you see one year after you stop treatment? So a patient is treated for 24 months and then followed for another year.

[Jeremy Bender, CEO at Day One Biopharmaceuticals]

What portion of those patients that have that three-year time horizon have required another therapy, and what patients have not required another therapy? And what they report to us is that any percentage greater than about 50% not requiring therapy in that one-year period is very encouraging. So that's what we're really focused on, Ami, at the three-year data cut that you'll see at SNO. And I think that frames the two big things that we're looking at. I don't want to minimize the substance of what Mike also mentioned, which is the. More detailed assessments of time to next therapy as well as treatment-free interval. Let me pause there. I know that's a lot. Mike, anything you want to add?

[Michael Vasconcelles, Head of Research and Development at Day One Biopharmaceuticals]

Thanks, Jeremy. Now, the only thing I'd add is just please keep in mind that any measure of rebound growth of tumor or progression is really sort of an early clinical surrogate for needing to intervene in some way in a disease where, as Jeremy mentioned, the balance of intervening with therapy versus managing the chronicity of the disease is very important. And so that's why this rebound question is clinically important, but really in the context of what's even more important, which is how long are patients off therapy and what's the interval before their next therapy?

[Ami Fadia, Senior Analyst at Needham & Company]

Thank you. That was very helpful. My second question is just sort of around the commercial landscape, and that slide number 11 is quite helpful with understanding kind of the depth of prescribing. Can you give us a sense of what is sort of the concentration of patients in physician offices? When you're at, say, 90+ patients, does that mean that you've sort of exhausted a big percentage of the number of patients that that physician might be treating, or is that still? Does that still mean that there's sort of a long way to go in terms of deepening that prescribing at that particular physician? Thank you.

[Jeremy Bender, CEO at Day One Biopharmaceuticals]

Sure. I mean, I'll let Lauren answer, but the short answer from my perspective is no. We're just scratching the surface, and this greater depth is fabulous, but there's a long way to go. But Lauren, maybe you can talk in more detail.

[Lauren Merendino, Chief Commercial Officer at Day One Biopharmaceuticals]

Yeah. I absolutely agree. So. Remember, there is variability as in any market with how many patients are at each account. That's why we have different priorities of accounts. So you've heard us in past calls, we didn't really talk about it much in this one, but in past calls that we have priority one, two, and three accounts. A significant number of those nine patient accounts are our priority one accounts. They have a considerable volume of patients and have a lot more potential to prescribe. So we're not worried at all at this point of kind of capping out. Physicians report to us many more patients. And so we continue to see opportunity.

[Ami Fadia, Senior Analyst at Needham & Company]

Thank you.

[Jeremy Bender, CEO at Day One Biopharmaceuticals]

Thanks, Ami.

[Operator]

Our next question comes from Andres Maldonado with H.C. Wainwright. Please proceed with your question.

[Andres Maldonado, Senior Biotechnology Analyst at H.C. Wainwright]

Hi, guys. Thanks for taking my question and congrats on all the progress so far. Two quick ones from us. Kind of dig into a little bit. The new patient starts as a key revenue driver. Obviously, the question is, do you guys view all new patient starts as equal? And are you seeing differences in persistence or dose modification needs based on particularly the reason for switching, elective switch, toxicity, or progression? And then the second question. On the FIREFLY-2 study, given that it includes recurrent and crossover, curious how you're framing expectations on efficacy if the crossover leads to a potential compression of the perceived delta versus standard of care for that study. Thank you very much for taking my questions.

[Jeremy Bender, CEO at Day One Biopharmaceuticals]

Thanks, Andres. Let me ask Mike to start with your FIREFLY-2 question, and then we'll come back to the question about the commercial setting, and Lauren can address.

[Michael Vasconcelles, Head of Research and Development at Day One Biopharmaceuticals]

Thanks, Jeremy. Yeah, just a couple of key points to keep in mind with FIREFLY-2. The primary initial efficacy endpoint is objective response rate between the two study arms. And the primary time-to-event endpoint is a measure of progression. And the third point I'd make is that the opportunity to crossover to receive tovorafenib is very tightly managed within both the study design and the operationalization of the study. So it's our expectation that that component of the study, first of all, it'll be really helpful and meaningful data, clinical data that we'll generate with respect to the subset of patients that do receive tovorafenib after first-line treatment in that construct. But for the primary endpoints of the study, we don't really see any concern given the way that we've designed the study and operationalized its oversight.

[Jeremy Bender, CEO at Day One Biopharmaceuticals]

Thanks, Mike.

[Lauren Merendino, Chief Commercial Officer at Day One Biopharmaceuticals]

And then back to your MPS question. So first of all, MPS is a key revenue driver for us beyond the quarter, right? Because obviously, these patients stay on for long periods of time. So although they may start in this quarter, they actually have a greater impact in future quarters because they'll get three refills in a quarter as opposed to if they came on in the later half of the quarter, they don't get three this quarter, right? So, MPS is important for our long-term trajectory. Your question about whether they're all equal in dose modification. I would say we look at patients by line. And so we do think that second line is a more desirable place to be, number one, because the patient is likely less complicated from a health perspective. But secondly, because it's a larger pool of patients than the later lines, right?

[Lauren Merendino, Chief Commercial Officer at Day One Biopharmaceuticals]

And so I would say that's how we're looking at patients. We're not really categorizing them in other ways. But to your point about dose modification, I just wanted to point out that our price is the same regardless of dose. So actually, dose modification is an important part of AE management. And we see that patients that get dose modification actually do better. So, we think that's an important thing for physicians to be comfortable doing, and it doesn't in any way impact our bottom line or top line.

[Andres Maldonado, Senior Biotechnology Analyst at H.C. Wainwright]

Thank you very much.

[Jeremy Bender, CEO at Day One Biopharmaceuticals]

Great. Thanks. Thanks, Andres.

[Operator]

We have reached the end of the question and answer session, and this concludes today's conference. You may disconnect your lines at this time, and we thank you for your participation.

Participants

Executives

• Michael Vasconcelles, Head of Research and Development
• Charles York, COO and CFO
• Jeremy Bender, CEO
• Joey Perrone, SVP of Finance and Investor Relations
• Lauren Merendino, Chief Commercial Officer

Analysts

• Ami Fadia, Senior Analyst at Needham & Company
• Morgan Lamberti, Equity Research Associate at Goldman Sachs
• Kelsey Goodwin, Senior Research Analyst at Piper Sandler
• Anupam Rama, Stock Analyst at JPMorgan
• Alec Stranahan, VP of Equity Research at Bank of America
• Tara Bancroft, Director of Biotech Equity Research and Senior Analyst at TD Securities
• Andres Maldonado, Senior Biotechnology Analyst at H.C. Wainwright