Day One Biopharmaceuticals Q2 2025 Earnings Call Transcript

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Provided by Quartr
August 5, 2025

Key Takeaways

  • Positive Sentiment: In Q2, Agenda delivered $33.6 M in net product revenue (up 10% QoQ) and exceeded 1,000 prescriptions, bringing trailing-twelve-month net revenue to $113.1 M. The company issued full-year 2025 net revenue guidance of $140–150 M.
  • Positive Sentiment: Prescription growth remained robust with 15% QoQ increase, over 60% of prescribing accounts treating multiple patients, and high payer coverage driving faster time to treatment.
  • Positive Sentiment: Pipeline advancement includes on-track enrollment for the FIREFLY 2 frontline PLGG trial (completion expected in 2026) and EMA acceptance of Ogenda’s MAA filing via partner Ipsen, targeting approval mid-2026.
  • Negative Sentiment: Day One discontinued its VRK1 program licensed from Sprint Biosciences, narrowing its early-stage oncology pipeline and potentially limiting future R&D optionality.
  • Positive Sentiment: The company closed Q2 with $453 M in cash and no debt, reduced operating expenses by 5% QoQ, and halved net cash used in operating activities, underscoring disciplined capital allocation.
AI Generated. May Contain Errors.
Earnings Conference Call
Day One Biopharmaceuticals Q2 2025
00:00 / 00:00

There are 11 speakers on the call.

Operator

and welcome to the Day one Biopharmaceuticals Q2 twenty twenty five Earnings Conference Call. At this time, all participants are in listen only mode. A question and answer session will follow the formal presentation. As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Joey Peroni, Senior Vice President of Finance and Investor Relations.

Operator

Please go ahead, sir.

Speaker 1

Thank you. Hello, everyone, and good afternoon. Welcome to Day one's second quarter financial and operating results conference call. Earlier today, we issued a press release, which 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.day1bio.com.

Speaker 1

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. 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 may 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.

Speaker 1

You are cautioned not to place any undue reliance on these forward looking statements and except as required by law, Day one disclaims any obligation to update such statements. Today, I am joined by Doctor. Jeremy Bender, Chief Executive Officer Lauren Marandino, 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.

Speaker 2

Thank you, Joey. Good afternoon, and thank you all for joining us. This quarter marks a pivotal moment, one full year since the approval of Agenda. In just twelve months, Agenda has not only met expectations, it has exceeded them. With $113,100,000 in cumulative net revenue for the most recent twelve months, we've demonstrated clear commercial momentum, strong physician adoption, and sustained patient demand.

Speaker 2

With Agenda's approval, we've transformed day one into a commercial organization and laid the groundwork for long term value creation. We've built a high performing focused company with demonstrated execution, a solid financial position and a portfolio that will deliver durable growth. For the second quarter, we again delivered double digit top line revenue growth, generating $33,600,000 in net product revenue, up 10% over our first quarter. Our total volume in Q2 exceeded 1,000 scripts for the first time, underscoring Agenda's continued adoption in the market. Our continued growth and performance highlight the importance of this medicine to the physicians, patients, and caregivers in the PLGG community.

Speaker 2

Today, we're also issuing net product revenue guidance for the first time. We project total net revenues of between $140,000,000 and $150,000,000 for full year 2025. This guidance is grounded in strong and persistent demand, deepening prescriber adoption, and consistent payer coverage. Looking forward, we remain sharply focused on OJEMDA commercialization and expansion. We have a clear opportunity to establish Ogenda as a standard of care in second line plus PLGG.

Speaker 2

We also have opportunities in the near term for significant potential indication expansion for Ogenda. In frontline PLGG here in The U. S. Through our FIREFLY two trial and in second line PLGG in Europe through our partner Ipsen's filing of an MAA. Our global FIREFLY two confirmatory first line trial remains on track for completion of enrollment in the 2026.

Speaker 2

And our partner Ipsen announced EMA acceptance of the Ogenda filing in Q1 and potential EMA approval mid-twenty twenty six. We share Ipsen's commitment to patients and will continue to support their filings to help more patients and physicians gain access to Agenda. In Q2, we also welcomed Mike Baskinsells to the company as Head of Research and Development. Mike brings decades of experience and success in oncology development and will play a pivotal role in driving the next phase of day one's growth. We are also prosecuting our broader portfolio beyond agenda.

Speaker 2

We recently discontinued our investment in the VRK1 program we had in licensed from Sprint Biosciences. Importantly, we are advancing our PTK7 targeted ADC day three zero one through the dose escalation portion of our Phase 1a trial, and we continue to actively evaluate new opportunities for portfolio expansion. Our strong financial position remains a strategic advantage. We closed Q2 with a strong balance sheet and growing product revenue, giving us the flexibility to execute our plans without reliance on the capital markets. We are focused, well capitalized, and committed to delivering meaningful value for patients and shareholders through our strategy to develop and commercialize new medicines.

Speaker 2

I'll now turn the call over to Lauren to discuss our commercial progress in greater detail.

Speaker 3

Thanks, Jeremy. Ogenda continued to demonstrate strong commercial performance in the second quarter, delivering $33,600,000 in net product revenue. This reflects double digit growth over the prior quarter and marks the first time that we've surpassed 1,000 total prescriptions in a quarter. The 15% quarter over quarter growth in prescriptions was driven by steady expansion across both the number of prescribing accounts, or breadth, and the number of patients per account, or depth. More details on this in a moment.

Speaker 3

On a trailing twelve month basis, Agenda has now generated over $113,000,000 in net revenue, well beyond initial expectations of where this brand would be at this point in our launch. In addition to strong demand, a high rate of payer coverage continues to be a key contributor to our strong financial performance. Over ninety five percent of patients on Agenda are paid patients with less than 5% receiving free drug. Additionally, about ninety percent of patients receive approval upon initial submission, helping to reduce the administrative burden on HCPs and leading to faster time to treatment for patients. Looking at revenue over the past twelve months, we've seen significant and consistent growth with a compound quarterly growth rate of 22.

Speaker 3

Even with this growth, considerable opportunity remains. Many eligible patients have yet to receive Ogenda, and we are just beginning to realize the potential of this brand. In order to fully deliver on Ogenda's potential and establish a new standard of care in second line PLGG, we must continue to build the clinical evidence and at the same time encourage physicians to gain further experience with the brand. Our medical team continues to publish updated data and additional analyses, building a more robust case for Ogenda and creating opportunity for the commercial team to keep providing valuable information to our customers. We recently introduced two year follow-up data from FIREFLY one patients, and at ASCO in June, we published additional data characterizing growth velocity recovery and effective rash management.

Speaker 3

These data provide important long term insights that reinforce the robust efficacy we reported previously, as well as offering new evidence of catch up growth in patients after therapy is completed. Physicians have consistently told us that these longer term data strengthen their confidence in Ogenda and further validate its broad use in appropriate relapsedrefractory patients in the real world. Prescription growth has remained strong with total prescriptions increasing by 15% quarter over quarter. This growth continues to be driven by a steady flow of new patient starts and strong persistence among patients already on therapy. We're also seeing an evolution in prescribing patterns.

Speaker 3

With increased familiarity and confidence, physicians are initiating OJEMDA earlier in the treatment journey. Based on recent market research conducted in June, second line Ogenda share has grown significantly in both BRAF fusion and mutation patient populations. Our field team has been instrumental in driving this momentum, consistently emphasizing Ogenda's differentiated efficacy, safety and dosing profile, and why we believe it should become the new standard of care in relapsedrefractory BRAF altered PLGG. The two year FIREFLY one data have further strengthened this positioning by speaking to both the durability of response and addressing the growth velocity questions. Following the release of these data, we saw a meaningful ramp up in new patient scripts in the latter half of Q2, and that trend has continued into July.

Speaker 3

These data have also helped us to continue to expand breadth and depth of prescribing. So let's take a closer look. This graph shows updated breadth and depth metrics for Ogenda prescribing. The top line reflects the total number of unique accounts that have initiated new patients, while the layered segments illustrate the number of new patient starts per account. These data reflect commercial patients only and exclude any patients treated through our early access program.

Speaker 3

We're pleased to report that over sixty percent of prescribing accounts have now started multiple patients on Ogenda, with nearly twenty percent of accounts initiating treatment in five or more patients. We believe this strong depth of prescribing is a positive indicator of growing physician confidence and satisfaction with this product. As we look to the second half of the year, our commercial priorities remain clear. Drive continued growth through increased breadth and depth of prescribing, expand second line use, and optimize treatment duration. While these focus areas remain consistent, our approach continues to evolve.

Speaker 3

We are leveraging the latest prescriber insights, exploring alternate data sources, and leveraging innovative approaches such as AI to strategically target our resources and identify emerging opportunities. At the same time, our clinical and med affairs teams are generating additional data and publications that enhance the Ogenda value proposition. We're looking forward to the three year follow-up data for FIREFLY one, including additional efficacy and safety analyses that we expect to release in the fourth quarter of this year. As the body of evidence grows, we see increasing opportunities to solidify Ogenda as the new standard of care in relapsedrefractory PLGG. With that, I'll turn it over to Charles who will walk through the financials in more detail.

Speaker 4

Good afternoon, everyone. Earlier today we reported detailed second quarter twenty twenty five financial results in our earnings release. And for today's call, I'll highlight a few key points. As we pass the one year point since launch, we see Ogemda revenue continue its steady upward growth trajectory. In the second quarter, U.

Speaker 4

Ogemda net product revenue was $33,600,000 which grew 10% compared to the first quarter. Our Q2 results bring our year to date net product revenue to $64,100,000 and our trailing twelve month revenue to $113,100,000 a fantastic start to our launch. As Jeremy highlighted earlier, we are providing full year 2025 Ogenda net product revenue guidance of 140,000,000 to $150,000,000 The midpoint of the guidance range implies approximately 150% year over year growth, which builds on the strong launch results delivered to date. It also reflects continued momentum in the launch trajectory and in achieving our goal of establishing Ogemda as a standard of care in the relapsedrefractory setting. Where we land in this range will be determined by two critical variables.

Speaker 4

First, persistence on therapy for patients continuing on Ogemda, And second, the pace of new patient starts. For the second quarter, total costs and operating expenses were $68,900,000 which includes $10,900,000 in non cash stock based compensation. This represents approximately 5% decrease quarter over quarter. Additionally, net cash used in operating activities decreased significantly quarter over quarter, approximately 50%, reflecting our continued focus on disciplined execution while advancing our investment opportunities. Given today's challenging markets, we see prioritizing a balanced approach to delivering top line expansion paired with thoughtful cost control as a responsible capital allocation strategy.

Speaker 4

Finally, we remain in a strong financial position ending the quarter with $453,000,000 in cash and no debt. Looking forward, our robust balance sheet positions us to advance our priorities and capitalize on the opportunities ahead, including completion of the frontline FIREFLY two trial for Agenda and advancing day three zero one. I'll now hand back to Jeremy for his final thoughts.

Speaker 2

Thank you, Charles. To close, I'd like to share a story that captures the essence of what motivates all of us at day one. The story is of a four year old living with PLGG. Late last year, this child was experiencing vision loss due to his BRAF altered optic pathway glioma. He was nearly color blind and was also struggling with walking due to his vision loss.

Speaker 2

This past January, his care team decided to treat his tumor with Agenda. His vision, including color clarity, improved after only a month on therapy. It's now seven months later, and this brave young four year old remains on therapy. His family reports that their son is now having a more typical childhood. He's coloring, playing with friends, and walking without assistance.

Speaker 2

All of us at day one, myself included, are here because we are inspired by stories like this young boy's. We are committed not only to enabling as much patient impact as we can with Ogenda, but also to developing new medicines that bring hope to more children and adults living with cancer. I'll now turn the call over to the operator for Q and A.

Speaker 5

Thank you,

Operator

A confirmation tone will indicate your line is in the question queue. You may press star and then 2 if you would like to remove your question from the queue. Again, if you would like to ask a question, First question that we have comes from Anupam Rama of JPMorgan. Please go ahead.

Speaker 6

Hi, guys. This is Priyanka on for upam. Congrats on the quarter. Just a quick question from us. So looking at the newly provided 2025 guidance, seems second half is estimated to be around 76,000,000 to $86,000,000 First half, of course, was 64,000,000 What couple of levers in particular will you focus on to increase the growth rate?

Speaker 6

Thanks.

Speaker 2

Hi, Priyanka. This is Jeremy. Thanks so much for joining and for the question. There's really two key variables that are critical to defining range that we provided for guidance for revenue for fiscal year twenty twenty five, and they're really continued adoption the form of new patient starts and persistence on therapy. And we've reached a point in the launch at this stage where we feel that those two variables are more predictable than they had been given that we're about a year away from launch and the trends we're seeing have led to that range.

Speaker 7

Thanks so much.

Operator

Thank you. Next question we have comes from Tara Bancroft of TD Cowen. Please go ahead.

Speaker 5

Hi, good afternoon guys. Seeing a thousand 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. 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, the rash management and reversibility of the growth impacts? Thanks.

Speaker 5

That's it.

Speaker 2

Thanks for the question, Tara. So yes, we were excited to hit a milestone, of course. But I think more importantly, as you note, really focused on the trajectory of what we're seeing in terms of growth that really does, was impacted by the two year data that you referenced. Why don't I ask Lauren to comment on what she and her team are seeing in the field to give you a sense of that, at least qualitatively?

Speaker 3

Yeah, thank you for the question. So the two year data has been received very positively by our customers, as I mentioned, and they're both confirming the efficacy and building confidence in our efficacy with additional follow-up. And then also, as you mentioned, the growth velocity data is reassuring to have additional volume of patients where we have evidence of catch up growth after stopping treatment. So those two things have been compelling for physicians and we have seen, as I mentioned, an uptick in starting new patients, and we're eager to continue that with continued promotion of these data.

Operator

Great. Thanks so much.

Speaker 2

Thank you.

Operator

Thank you. The next question we have comes from Andrea Newcock of Goldman Sachs. Please go ahead.

Speaker 8

Hey guys, good afternoon. Thanks for taking the question. 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 one 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 three year follow-up will meaningfully change their view versus the two year data that they've seen already? Thanks so much.

Speaker 2

Andrew, for the question. Let me start and I'll ask Lauren to comment on those last elements. What we're seeing in terms of persistence is very consistent with what you've heard me describe previously, and that is for on label patients, what we're seeing for persistence or the flip side of that potential for median duration of treatment is consistent with what we expected based on the FIREFLY one trial. We have not provided any estimate of what that median duration of treatment will be or what specific persistence values are, but what I can tell you is we still have not yet reached a median duration of treatment for patients since we've launched and been approved. So we're really confident that we're seeing fairly lengthy durations.

Speaker 2

Let me ask Lauren to now comment on both the two year data as it relates to persistence and intent and the three year data.

Speaker 3

Yes, so you mentioned you asked about intent. So as we've discussed previously, many physicians, their intent is to keep a patient on treatment for two years, if possible, as long as that patient does not progress. And we continue to hear that from physicians, many of them are still anchored to this two year concept. As we think about the two year data versus the three year data, the three year data will have more evidence of what happens after patients either stop therapy or if they continue on therapy beyond those two years. And so I think that will be very informative and additive to the data that we have now.

Operator

Thank you. Thank you. The next question we have comes from Alex Stramahan of Bank of America. Please go ahead.

Speaker 9

Hey, guys. This is Matthew on for Alex. Appreciate you taking our questions. Maybe just double clicking on a previous point. Is the distribution of total scripts attributed to repeat versus new prescriptions holding relatively constant between Q1 and Q2?

Speaker 9

And then second question, curious how dropouts have been trending and whether ASCO updates on skin AEs are helping to sign your strategy moving forward? Thanks.

Speaker 2

Lauren, do you want to take those?

Speaker 3

Sure. So as far as distribution of TRX and NRX, I actually haven't calculated the ratio and looked at them comparatively quarter over quarter, so I can't be too specific there. But what I can tell you is that we continue to focus on driving new patient starts in NRx and the two year data does seem to be very compelling to our customers. So we'll continue to share that data as we move forward. From a drop off perspective, it's been fairly consistent with what we've seen previously.

Speaker 3

And I'm trying to remember if there was more

Speaker 2

Yeah, think, let me, yeah, I'll just Sorry. No, Matthew, good question. The ASCO data that came out with respect to rash management, I do think is important as far as helping us to manage, especially those physicians who don't have prior experience with Ogenda, to prevent any dropouts that might be premature and not give the patient sufficient time to achieve a really good efficacy result. So that is, we think, valuable. I wouldn't say it's showing up dramatically in the data yet given just how recently ASCO occurred.

Speaker 2

That being said, as we track the sort of overall persistence curves over time, we are seeing positive trends as physicians get more experience with Ogenda and as all of the tools that we've had available and have made available throughout the launch become better known and understood by treating physicians, by office staff, and by caregivers. They're pretty significant investments that we've made in those areas really since launch.

Speaker 3

Yeah, and just to add to that, rash tends to be one of the first AEs that is seen early on in treatment, and so it is important that physicians not only manage it but take proactive steps before the child has a rash in order to lead to the best outcomes. And so I think since launch we have increased the messaging around that to make sure that physicians are prepared to manage that AE proactively for the best success of their patients.

Operator

Thank you. Next question we have comes from Ami Fadia of Needham and Co. Please go ahead.

Speaker 7

Hi, this is Puna on for Ami. Thank you for taking our question. I guess continuing on from 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 the gross to net for this quarter? And separately for the ADC Day three zero one, 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?

Speaker 7

Thank you.

Speaker 2

Certainly. So I'm going to ask Charles to comment on your guidance topic and then Mike to comment on day three zero one.

Speaker 4

Thanks, Jeremy. So for the guidance range itself, very similar assumptions to how we've discussed this launch previously and what Jeremy and Lauren highlighted earlier. In general, in order to meet that, we believe we're going to have to have continued persistence, continued duration for patients, and this steady increase in new patient starts that we've continued to see. Other important factors in there though are minimizing the fluctuations on a couple of other items that we have that we've talked about previously. First being channel stock, and in order to meet that range, we'll need to keep the previously guided two to four weeks of general stock on hand still in place.

Speaker 4

And we expect that gross to net range to still remain in that 12% to 50% that we've talked about previously. Those are the main assumptions associated with this in addition to the work to gross scripts.

Speaker 2

Thanks, Charles. And Mike, can you comment on 301?

Speaker 10

Sure, thanks, Jeremy. Thanks for the question, Buna. We're really doing quite nicely through phase one dose escalation. We have a really engaged group of investigators, and things are progressing about as we would expect or anticipate for a molecule of this class and target. With respect to the benchmark, I think we'll have to keep an eye on that.

Speaker 10

We certainly know of some early phase programs against a target. It's been a target of interest for some time, but it's really a target that, at least historically, has been a little bit of a challenge, at least with one prior molecule. We think we've got a very innovative molecule against PTK7, and we'll keep an eye on how others progress. There's a broad opportunity in terms of expression patterns, so as we move through Phase I and then define our expansion cohorts, we'll look forward to sharing those details with you.

Speaker 7

Thank you so much.

Speaker 2

Thank you.

Operator

Thank you. Ladies and gentlemen, we have reached the end of our question and answer session. Thank you for joining us today. Thank you for joining today's conference. You may disconnect your lines.

Operator

Thank you for your participation.

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