Q2 2025 Day One Biopharmaceuticals Inc Earnings Call
Operator: Greetings, and welcome to the Day One Biopharmaceuticals Q2 2025 earnings conference call. At this time, all participants are in listen-only mode. Question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star then zero on your telephone keypad. As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Joey Perrone, Senior Vice President of Finance and Investor Relations. Please go ahead, sir.
Greetings and welcome to the day 1, biofarma surgical Q2 2025 earnings conference call.
At this time, all participants are in listen-only mode.
Question. Answer session will follow the formal presentation.
If anyone should require operator assistance during the conference, please press star, then zero on your telephone keypad.
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. Please go ahead sir.
Joey Perrone: 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.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.
Thank you. Hello everyone, and good afternoon. Welcome to the Day One Biopharmaceuticals, Inc. Q2 2025 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.dayonebio.com.
An audio webcast with a corresponding slide. This is 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 4 looking statements as outlined on slide 2.
Joey Perrone: 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. 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 Dr. Jeremy Bender, Chief Executive Officer, Lauren Merendino, Chief Commercial Officer, Charles York, Chief Operating and Financial Officer, and Michael Vasconcelos, Head of Research and Development. I will now turn the call over to Jeremy.
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 4 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, 1, disclaims, any obligation to update such statements
today, I am joined by Dr. Jeremy Bender. Chief executive officer Lauren Marino, Chief commercial officer.
Charles York, Chief Operating and Financial Officer, and Michael Vas Gonzalez, Head of Research and Development. I will now turn the call over to Jeremy.
Jeremy Bender: 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 OGENDA. In just 12 months, OGENDA has not only met expectations; it has exceeded them. With $113.1 million in cumulative net revenue for the most recent 12 months, we've demonstrated clear commercial momentum, strong physician adoption, and sustained patient demand. With OGENDA'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 $33.6 million in net product revenue, up 10% over our first quarter. Our total volume in Q2 exceeded 1,000 scripts for the first time, underscoring OGENDA's continued adoption in the market.
Thank you, Joey. Good afternoon, and thank you all for joining us.
This quarter marks a pivotal moment.
1 full year since the approval of ojama in just 12 months, agenda has not only met expectations, it has exceeded them.
With a 113.1 million dollars in cumulative, net revenue for the most recent, 12 months, we've demonstrated, clear, commercial momentum. Strong physician adoption and sustained patient demand.
With agendas approval, we've transformed day, 1 into a commercial organization, and laid the groundwork for long-term value creation.
We 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, Topline, Revenue growth.
Generating $33.6 million in net product revenue, a 10% increase over our first quarter.
our total volume in Q2, exceeded, 1,000 scripts, for the first time,
Underscoring, agendas continued adoption in the markets.
Jeremy Bender: Our continued growth and performance highlight the importance of this medicine to the physicians, patients, and caregivers in the PLGG community. Today, we're also issuing net product revenue guidance for the first time. We project total net revenues of between $140 and $150 million 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 OGENDA commercialization and expansion. We have a clear opportunity to establish OGENDA as the standard of care in second-line plus PLGG. We also have opportunities in the near term for significant potential indication expansion for OGENDA in front-line PLGG here in the US through our Firefly 2 trial and in second-line plus PLGG in Europe through our partner Ipsen's filing of an MAA.
Our continued growth and performance highlight. The importance of this medicine to the positions patients and caregivers in the PGG community.
Today, we're also issuing net product, Revenue guidance for the first time.
We project total net revenues of between 140 and 150 million dollars for fully year 2025.
This guidance is grounded in strong and persistent demand.
Prescriber adoption and consistent payer coverage.
Looking forward we remain sharply focused on ogenda, commercialization and expansion.
We have a clear opportunity to establish agenda as a standard of care in second line, plus PGG.
We also have opportunities in the near term for significant potential indication expansion for agenda.
In Frontline plg here in the US, through our Firefly 2 trial and in second line plus PGG in Europe through our partnered. Ipsen's filing of an MAA
Jeremy Bender: Our global Firefly 2 confirmatory first-line trial remains on track for completion of enrollment in the first half of 2026, and our partner Ipsen announced EMA acceptance of the OGENDA filing in Q1 and potential EMA approval mid-2026. We share Ipsen's commitment to patients and will continue to support their filings to help more patients and physicians gain access to OGENDA. In Q2, we also welcomed Mike Vasconcelos 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 OGENDA. We recently discontinued our investment in the VRK1 program. We had in-licensed Termsprint Biosciences.
our Global Firefly 2 confirmatory, first line trial remains on track for completion of enrollment in the first half of 2026,
And our partner ifen announced EMA acceptance of the oema filing in q1 and potential EMA, approval, mid 2026.
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 welcome, Mike fascin cells 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. 1's growth.
We are also prosecuting our broader portfolio beyond OJA.
We recently discontinued our investment in the vk1 program, we hit in licensed term, Sprint, biosciences.
Jeremy Bender: Importantly, we are advancing our PTK7 targeted ADC, Day 301, 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. I'll now turn the call over to Lauren to discuss our commercial progress in greater detail.
Importantly, we are advancing our PTK 7 targeted ADC, DAY-301, through the dose escalation portion of our Phase 1 trial. We continue to actively evaluate new opportunities for portfolio expansion.
Our strong financial position remains a strategic advantage.
We close 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.
I'll now turn the call over to Lauren to discuss our commercial progress in Greater detail.
Lauren Merendino: Thanks, Jeremy. OGENDA continued to demonstrate strong commercial performance in the second quarter, delivering $33.6 million 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 BREFs, and the number of patients per account, or DEFs. More details on this in a moment. On a trailing 12-month basis, OGENDA has now generated over $113 million 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 95% of patients on OGENDA are paid patients, with less than 5% receiving free drug.
Thanks, Jeremy. Agenda continued to demonstrate strong commercial performance in the second quarter, delivering $33.6 million in net product revenue.
This reflects double-digit growth over the prior quarter.
And marks the first time that we've surpassed a thousand 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 breathe.
And the number of patients per account or depth.
More details on this in a moment.
On a trailing 12-month basis. Ogenda has now generated over 13 million dollars 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 95% of patients on agenda, are paid patients with less than 5%. Receiving free drug.
Lauren Merendino: Additionally, about 90% 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 12 months, we've seen significant and consistent growth, with a compound quarterly growth rate of 22%. 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.
Additionally about 90% 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 12 months, we've seen significant and consistent growth.
With a compound quarterly growth rate of 22%.
Even with this growth, considerable opportunity remains.
Many eligible patients have yet to receive agenda and we are just beginning to realize the potential of this brand.
In order to fully deliver on oem's potential, and establish a new standard of care and second-line plg.
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 aghdas, and creating opportunity for the commercial team to keep providing valuable information to our customers.
Lauren Merendino: We recently introduced two-year follow-up data from Firefly 1 patients, and at ASCO in June, we published additional data characterizing growth velocity recovery and effective rash management. 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 relapse-refractory 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. With increased familiarity and confidence, physicians are initiating OGENDA earlier in the treatment journey.
we recently introduced 2-year, follow-up data, from Firefly, 1, patients,
At the ASCO in June, we published additional data characterizing growth, velocity recovery, and effective rash management.
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 strengthened their confidence in agenda and further validate its broad use in appropriate relapse, refractory 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.
With increased familiarity and confidence, physicians are initiating OJA earlier in the treatment journey.
Lauren Merendino: 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 relapse-refractory BRAF-altered PLGG. The two-year Firefly 1 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. 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.
Based on recent market research conducted in June,
Second line of gender share has grown significantly in both bra fusion and mutation patient populations.
Our field team has been instrumental in driving. This momentum, consistently emphasizing oema, differentiated efficacy, safety, and dosing profile.
And why we believe it should become the new standard of care in relapse refractory brap altered plg.
G the 2-year, Firefly 1 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.
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 agenda. Prescribing
Lauren Merendino: 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. We're pleased to report that over 60% of prescribing accounts have now started multiple patients on OGENDA, with nearly 20% 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.
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
We're pleased to report that over 60% of prescribing accounts have now started multiple patients on Ogenda, with nearly 20% of accounts initiating treatment in 5 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.
Lauren Merendino: 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 1, 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 relapse-refractory PLGG. With that, I'll turn it over to Charles, who will walk through the financials in more detail.
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 metaphors teams are generating additional data and Publications that enhance the Ogemaw value proposition.
We're looking forward to the 3-year follow-up data for Firefly 1, 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 agenda as the new standard of care and relapse refractory plg.
With that, I'll turn it over to Charles who will walk through the financials in more detail.
Jeremy Bender: Good afternoon, everyone. Earlier today, we reported detailed second quarter 2025 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 OGENDA revenue continue its steady upward growth trajectory. In the second quarter, US OGENDA net product revenue was $33.6 million, which grew 10% compared to the first quarter. Our Q2 results bring our year-to-date net product revenue to $64.1 million and our trailing 12-month revenue to $113.1 million, a fantastic start to our launch. As Jeremy highlighted earlier, we are providing full-year 2025 OGENDA net product revenue guidance of $140 to $150 million. The midpoint of the guidance range implies approximately 150% year-over-year growth, which builds on the strong launch results delivered to date.
Good afternoon. Everyone earlier today, we reported detailed second quarter, 2025 Financial results in our earnings release and for today's call, I'll highlight a few key points.
As we pass the 1-year points since launch, we see OEM door Revenue, continue its steady upward growth trajectory in the second quarter us OEM to net product. Revenue was 33.6 Million which grew 10% compared to the first quarter.
Our Q2 results, bring our year-to-date, net product Revenue to 64.1 million and our trailing 12-month Revenue to 113.1 million, a fantastic start to our launch.
The midpoint of the guidance range implies approximately 150% year-over-year growth, which Builds on the strong launch results delivered to date.
Jeremy Bender: It also reflects continued momentum in the launch trajectory and in achieving our goal of establishing OGENDA as a standard of care in the relapse-refractory setting. Where we land in this range will be determined by two critical variables. First, persistence on therapy for patients continuing on OGENDA, and second, the pace of new patient starts. For the second quarter, total costs and operating expenses were $68.9 million, which includes $10.9 million in non-cash stock-based compensation. This represents approximately a 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.
It also reflects continued momentum in the loss trajectory and in achieving our goal of establishing agenda as a standard of care in the relapse refractory setting.
Where we land in this range will be determined by 2 critical verbs, first persistence on therapy for patients continuing on agenda.
And second, the pace of new patients starts.
For the second quarter, total costs and operating expenses were $68.9 million, which includes $10.9 million in non-cash, stock-based compensation.
This represents approximately 5% decreased quarter of a quarter.
Additionally, net cash used in operating activities decreased significantly. Quarter of a 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 Topline expansion paired, with thoughtful cost control as a responsible Capital allocation strategy.
Jeremy Bender: Finally, we remain in a strong financial position, ending the quarter with $453 million 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 front-line Firefly 2 trial for OGENDA and advancing Day 301. I'll now hand back to Jeremy for his final thoughts.
Finally, we remain in a strong financial position, ending the quarter with 453 million 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 and Firefly 2 trial for agenda and advancing Dei 301.
I'll now hand back to Jeremy for his final thoughts.
Joey Perrone: Thank you, Charles. To close, I'd like to share a story that captured 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 colorblind and was also struggling with walking due to his vision loss. This past January, his care team decided to treat his tumor with OGENDA. 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. All of us at Day One, myself included, are here because we're inspired by stories like this young boy's.
Thank you, Charles to close. I'd like to share a story that captures the essence of what motivates all of us at day 1.
The story is of a 4 year old living with PGG.
Late last year, this child was experiencing vision loss due to his B rap altered optic, pathway glioma.
He was nearly colorblind and was also struggling with walking due to his visual loss.
This past, January, his care team decided to treat his tumor with aema.
His vision, including color clarity, improved after only a month on therapy.
it's now 7 months later and this Brave Young 4 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.
Joey Perrone: We're 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&A.
All of us at day. 1 myself included are here because we are inspired by stories, like this young boys.
We're committed not only to enabling as much patient impact as we can with oema. 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&A.
Operator: Thank you, sir. Ladies and gentlemen, we will now begin the question and answer session. If you would like to ask a question, please press star and then one. A confirmation tone will indicate your line is in the question queue. You may press star and then two if you would like to remove your question from the queue. Again, if you would like to ask a question, please press star and then one now. First question that we have comes from Anupam Rama of JP Morgan. Please go ahead.
Thank you. So
ladies and gentlemen, we will now begin the question and answer session.
If you would like to ask a question, please press star and then one.
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, please press star and then 1 now.
First question that we have comes from Anu, Palmer of JD JP Morgan. Please go ahead.
Analyst: Hi, guys. This is Priyanka and Pranapam. Congrats on the quarter. Just a quick question from us. So looking at the newly provided 2025 guidance, the second half is estimated to be around $76 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? Thanks.
Hi, guys, this is Priyanka and vopal. 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, to 86 million, first half of course, was 64 million. So what couple of levers in particular, really focus on to increase the growth rate, thanks.
Jeremy Bender: 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 the range that we've provided for guidance for revenue for fiscal year 2025, and they're really continued adoption in 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.
Hi Priyanka, this is Jeremy. Thanks so much for joining. And for the question, um, there's really 2 key variables that are critical to defining the range that we provided for guidance for, uh, for revenue, for fiscal year 2025 and, and they're really continue to adoption. And, and the form of new patient starts, um, and persistence on therapy. And we've reached a point in the launch at this stage where we feel um, that those uh, 2 variables are are more predictable than they had been given that we're about a year away from launch and and the trends were seeing have led to that range.
Analyst: Thanks so much.
Thanks so much.
Jeremy Bender: Thank you.
Thank you.
Operator: Next question we have comes from Tara Bancroft of TD Cohen. Please go ahead.
Next question, we have comes from Tara brofft of TD Cohen, please go ahead.
Analyst: Hi. Good afternoon, guys. So, you know, 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 know, 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. That's it.
Patients and and mostly I'm I'm asking because you know you mentioned the the increase in new patient scripts and the latter part of Q2. So I'm wondering um to what extent? Maybe the ASCO data might have contributed the rash Management in reversibility of the growth impacts. Um thanks that's it.
Jeremy Bender: Thanks for the question, Tara. So, yeah, 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, you know, really does was impacted by the two-year data that you referenced. Why don't I ask Lauren to comment on what, you know, she and her team are seeing in the field to give you a sense of that, at least qualitatively?
Thanks for the question Tara. So um yeah we were excited to hit a milestone of course but I think more importantly, as you note really focused on uh the trajectory of um what we're seeing in terms of of growth that that I you know it really does uh was impacted by um the the 2-year data that that you referenced. Um, why don't I ask Lauren to comment on what you know, she and her team are seeing in the field to give you a sense of that uh at least qualitatively.
Lauren Merendino: 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.
Yeah, thank you for the question. Um, so the 2-year data has been received very positively by our, our customers uh, as I mentioned and um, they're both. Um,
Confirming the efficacy and building confidence, uh, in our efficacy with additional follow-up. And then also, as you mentioned the, um, the growth philosophy data is reassuring to have, um, additional, um, volume of patients where we have, um, evidence of of catch-up growth, uh, after stopping treatment. So those 2 things have been compelling for Physicians and we have, um, seen as I mentioned and and uptick in uh, starting new patients and um,
Um, we're eager to continue that with continued, uh, promotion of these data.
Analyst: Great. Thanks so much.
Great. Thanks so much.
Jeremy Bender: Thank you.
Thank you.
Analyst: Thank you.
Operator: Ladies and gentlemen, just a reminder, if you would like to ask a question, please press star and then one now. The next question we have comes from Andrea Newkirk of Goldman Sachs. Please go ahead.
Thank you, ladies and gentlemen, just a reminder, if you would like to ask a question, please press star and then 1 now.
Analyst: 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.
The next question we have comes from Andrea Newark of Goldman Sachs. Please go ahead.
Jeremy Bender: Thanks, Andra, 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, you know, persistence or the flip side of that, potential for median duration of treatment is consistent with what we expected based on the Firefly 1 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, you know, confident that we're seeing, you know, fairly lengthy durations.
Hey guys, good afternoon. Thanks for taking the question. Um, Jeremy I or maybe Lauren, I was just wondering if you might be willing to speak um to what you're seeing with respect to durability or persistence now that you are 1 year into launch um and have greater Clarity there. What are you hearing from Physicians? Regarding their intentions for how they 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 um versus the 2-year data that that they've seen already. Thanks so much.
Thanks Andrew for the question. Let me start and, and I'll ask Lauren to comment on on those last elements. Um, we what we're seeing in terms of persistence is very consistent with what you've heard me describe, uh, previously and that is for on-label, uh, patients what we're seeing for, you know, persistence or the flip side of that. Um, uh, potential for, uh, median duration of treatment is consistent with what we expected based on the Firefly 1, Trials of treatment. You know, will be, or what specific persistence values are. Um, but what, what I can tell you is we
Jeremy Bender: 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.
Still have not yet reached a median duration of treatment for for patients. Um, since we've uh, We've launched and been approved. Uh, so we're we're really, you know, confident that we're, we're seeing, you know, fairly lengthy, uh, durations. Let me ask Lauren to now comment on both the, the 2 year data, as it relates to persistence, and intent. And, and the 3 year data,
Lauren Merendino: Yeah, 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, you know, 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.
Yeah, so, um, so you mentioned, you asked about intent. So, uh, as we've discussed previously many Physicians their intent is to keep a patient on treatment for 2 years. Uh, if possible as long as that patient does not progress, and we continue to hear that from Physicians. Many of them are still, um, you know, anchored to this 2-year concept. Um, as we think about the 2-year data, uh, versus the 3-year data, the 3 year data will have more uh, evidence of of what happens after patients either. Stop therapy or if they can continue on therapy Beyond those 2 years. And so, I think that will be very informative and additive to the data that we have now.
Operator: Thank you.
Thank you.
Lauren Merendino: Thank you.
Operator: The next question we have comes from Alex Strammehan of Bank of America. Please go ahead.
Thank you. The next question we have comes from Alex Strahan of Bank of America. Please go ahead.
Charles York: 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? And then second question, curious how dropouts have been trending and whether ASCO updates on skin AEs are helping design your strategy moving forward. Thanks.
Hey guys, this is Matthew on for Alec, 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, hold, like relatively constant between q1 and Q2. Uh, 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.
Joey Perrone: Lauren, do you want to take those?
Lauren, do you want to take those?
Lauren Merendino: 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, you know, we continue to focus on driving new patient starts and 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, you know, consistent with what we've seen previously. And I'm trying to remember if there was more.
Sure. So, um, as far as distribution of TRX and nrx, um, I actually haven't calculated the ratio and looked at them. Comparatively quarter over quarter, so I I can't be too specific there. Um, but what I can tell you is that, um, you know, we we, uh, continue to focus on driving new patient starts and nrx and, uh, the 2-year data does seem to be very compelling to our customers. So, we'll continue to, um, uh, to share that data as we move forward. Um, from a drop off perspective,
Jeremy Bender: Yeah, I think, I think, let me, yeah, I'll just.
Lauren Merendino: Sorry.
Jeremy Bender: No, no, 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, you know, 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 recent ASCO recently occurred. That being said, as we track the sort of overall persistence curves over time, you know, 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.
Um it's been um uh fairly you know consistent with what we've seen previously. Um and um I'm trying to remember if there was more. Yeah. I think I think let me yeah, I'll just no, no, no Matthew. Good question. The um, the the ASCO data that 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, um, to prevent any dropouts that might be premature and and, you know, not give the patient a sufficient time to to achieve a really a good efficacy result. Um, so that is we think valuable I I wouldn't say it's showing up dramatically in the data yet, given just how recent ASCO uh recently ASCO occurred that being said as we track, um, the uh, the the sort of overall, persistence curves over time, you know, we are seeing positive Trends as physician give as Physicians get more experience with
Jeremy Bender: And they're pretty significant investments that we've made in those areas really since launch.
so gender and, um, as all of the tools that we've had available and have made available throughout the launch, um, become better known and understood by by treating, Physicians, by office staff, and by caregivers and, and they're pretty significant, um, uh, Investments that we've made in, in those areas, uh, really since launch
Lauren Merendino: 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, you know, 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.
Yeah, and just just to add to that, rash tends to be 1 of the first AES that is seen early on in treatment. And so it is important that Physicians, not only manage it, but proactive take proactive steps before the child has a rash um, in order to lead to the best outcomes. And so I think, you know, since launch, we have increased the um messaging around that to make sure that Physicians are prepared, um, to to manage that AE proactively for the best success of their patients.
Operator: Thank you. Ladies and gentlemen, just a reminder, if you would like to ask a question, please press star and then one now. Next question we have comes from Amy Fadia of Needham & Co. Please go ahead.
Thank you.
Ladies and gentlemen, just a reminder, if you would like to ask a question, please press star and then 1 now.
Next question, we have comes from army, FIA of nidam and Co please go ahead.
Analyst: Hi, this is Poona on for Amy. 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 growth to net for this quarter? And separately, for the ADC Day 301, I 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? Thank you.
Hi. This is Pune on for Army. Thank you for taking our question. Um I guess continue on from previous questions. Could you provide additional color on what you're modeling in in your guidance? In terms of new additions versus discontinuous?
Um, and just curious, how is your gross to net? Uh, for this quarter, um, and separately, uh, for the ADC day 301. Um, just wanted to get some, uh, understanding on how the development is progressing. What is the what phase it is? Phase. It is in terms of those escalation and uh what's the Benchmark that you're looking at? Thank you.
Joey Perrone: Certainly. So I'm going to ask Charles to comment on your guidance topic and then Mike to comment on Day 301.
Certainly. So, I'm going to ask Charles to comment on your guidance topic, and then Mike to comment on Day 301.
Charles York: Thanks, Jeremy. So for the guidance range itself, very similar assumptions to how we've discussed this launch previously and what Jeremy and Lauren had 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, you know, minimizing the fluctuations on a couple of other items that we have and 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 channel stock on hand still in place. And we expect that growth to net range to still remain at that 12% to 15% that we've talked about previously.
Thanks Jeremy. So
for, uh, for the guidance range itself. Um, it's very similar assumptions to how we've discussed.
Uh, this launched previously, and what Jeremy and Lardat highlighted earlier, uh, in general. Um, in order to meet that, we believe we're going to have to have continued persistence, continued duration for patients, uh, and this steady increase in new patient starts that we've continued to see. Other important factors in there though, um, are, you know, minimizing the fluctuations on a couple of other items that we have. And we've talked about previously, first being channel stock, and in order to meet that range and...
Charles York: Those are the main assumptions associated with this initiative to work to grow scripts.
We'll need to keep the previously guided 2 to 4 weeks of General stock on hand still in place and we expect that gross in that range to still remain in that 12 to 50%. That we've talked about previously, those are the main assumptions associated with this addition to, you know, the work to to to grow Scripts
Joey Perrone: Thanks, Charles. And Mike, can you comment on 301?
Thanks, Charles, and Mike. Can you comment on 301?
Michael Vasconcelos: Sure. Thanks, Jeremy. Thanks for the question, Poona. 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 targets. With respect to the benchmark, I think we'll have to keep an eye on that. We certainly know of some early phase programs against the 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.
With respect to the Benchmark. Um, I think we'll have to keep an eye on that. We certainly, uh, know if some early phase programs against the target, it's been a target of interest for some time, but, um, um, it's really
A Target that.
Michael Vasconcelos: So as we move through phase one and then define our expansion cohorts, we'll look forward to sharing those details with you.
Uh, at least historically has has, uh, been a little bit of a challenge at least with 1 Pryor molecule. We think we've, uh, got a very Innovative, uh, uh, molecule against, um, against ptk 7 and, uh, 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 1, and then, uh, Define our, uh, expansion, cohorts, we'll look forward to sharing those details with you.
Analyst: Thank you so much.
Joey Perrone: Thank you.
So much.
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. We mean to disconnect your lines. Thank you for your participation.
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 need to disconnect your lines. Thank you for your participation.