Q3 2024 Day One Biopharmaceuticals Inc Earnings Call
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Speaker Change: Hello ladies and gentlemen and welcome to the day one by our pharmaceuticals third quarter of 2024 financial and operating results conference call.
Speaker Change: At this time, all participants are in listen only mode. Later, we will conduct a question on succession.
Speaker Change: Please be advised that this conference call is being recorded.
Speaker Change: I would now like to turn the conference call over to Joey Pironi. Senior Vice President of Finance and Investor Relations. Please go ahead, sir.
Joey Pironi: Thank you. Hello everyone and good afternoon. Welcome to day one third quarter, 2024, financial and operating results conference call. For earlier today, we issued a press release, which outlines the topics we plan to discuss today.
Speaker Change: You can access the press release and the slide to accompany this conference call on the investors and media section of our website at www.a1bio.com An audio webcast with the corresponding slides is also available on the website.
Speaker Change: Before we get started, I'll show you some of the statements we make on this call. An information presented in a slide deck will close forward looking statements as outweighed on slide 2.
Speaker Change: Actually, events and results could differ materially from those expressed or implied by any foreign-looking statements.
We encourage you to review the various risks, uncertainties, and other factors, including our most recent filings with the SEC. In any other feature filings that we may make with the SEC.
These four looking statements are based on our current estimates, in various assumptions and reflect management's intentions, beliefs, and expectations about future events, strategies, competition, products, and product candidates, operating plans, and performance.
Your caution not to place any undurilized only for looking statements, and acceptives required by law, they will undisturne any obligation to update such statements.
Speaker Change: Today I am joined by Dr. Jeremy Bender, Chief Executive Officer, Laura Mandito, Chief Commercial Officer, Charles York, Chief Operating and Financial Officer and Dr. Samuel Blackman, co-founder and head of our team. I will now turn the call over to Jeremy.
Thank you Joey and good afternoon everyone. I'm pleased to share our third quarter earnings results with you today.
Speaker Change: I will also provide an update on the three priorities we've emphasized for 2024. First, the successful launch and commercialization of agenda. Second, progress advancing our pipeline and third, the expansion of our portfolio.
Speaker Change: Day one had a remarkable third quarter. How Jim Debt, net product revenue for Q3, was $2.1 million, more than double what we reported last quarter.
Our early commercial experience is laying around the work for the company's future growth. We see a gem that, in real-time, is a foundation for day one.
Our commercial execution following approval and April of this year has driven persistent and steady growth of OGMD sales.
Speaker Change: We believe that growth reflects the significant on-met need for new treatment options in the real-after fractured or pediatric low-grably on-the-space.
Speaker Change: We've previously disclosed that the median duration of treatment observed for patients in R1 and Firefly 1 is 23.7 months.
Speaker Change: As we work towards a more complete analysis of the follow-up data from our registration of Firefly 1 trial, the median duration of response for patients in our 1 has now extended from 13.8 months to 18 months, which we believe speaks to the value of gender-is-brain
Given that on Metany, we remain confident in continuing future growth in our gender sales, and in the opportunity to increase the breadth and depth of our gender prescribers.
As we look ahead to 2025, we remain focused on enrollment in firefly to our global phase through frontline P.O.G. trial and the opportunity it provides to demonstrate the clinical benefit of total wrath in the best standard of care in the frontline setting.
You may also recall that we established the next U.S. partnership for agenda with Ipson earlier this year.
Speaker Change: We are working closely with our partners there to support successful registration and commercialization of OGMDA in EU and additional territories.
Speaker Change: We are also on track and on plan to dose the first patients in Q4 this year or early Q1 next year in the phase one trial of day 301.
Day 301 is the PKK 7 targeted ADC. We in-licensed mid-year following clearance of the IND by the US FDA for that program.
In day three or one, we have an opportunity to establish a first and or best in class program with potential across a broad set of adult and pediatric solid tumors.
Finally, as always, we continue to seek opportunities to drive value for our shareholders.
Our business development team continues to actively look for differentiated high quality clinical stage programs that sit our portfolio criteria and provide opportunities to improve patients' lives and build value.
We are in a strong financial position with over half a billion dollars in cash to fund our operating plan and to expand our portfolio in 2025.
We've made great early strides toward delivering on our mission in 2024 to develop new medicines for people of all ages with life-threatening diseases. And we're looking forward to continuing that work ahead.
Speaker Change: I'll now turn the call over to Lauren to discuss our commercial progress in greater detail.
Thank you Jeremy and hello everyone.
Today, we are thrilled to provide an update on our launch of OGEMDA with remarkable progress in Q3 on multiple fronts.
Lauren: In the five months since our approval, we have delivered a total of $28.3 million in net revenues, driven by over 850 total prescriptions and high-payor approval rates.
The momentum is encouraging and we believe there is continued opportunity for the brand. There are many more eligible PLGG patients who can benefit from OGenda and we have laid a solid foundation for future growth as we continue to further penetrate this market.
This quarter, we delivered $20.1 million in net product revenue for OGMDA, which represents an impressive 145% increase over last quarter.
There are two primary factors driving this growth.
First, we can take you to drive a strong flow of new patient starts.
We are expanding our prescriber base and increasing use by existing prescribers, resulting in a steady influx of new patients.
Secondly, we've seen a high percentage of patients continuing on therapy each month. This high-continuation rate for PLGG patients is consistent with what we saw on Firefly 1, where patients remain on OGMDF for a median duration of about 24 months.
In addition to these two demand drivers, OJUM has continued to see high-payer approval rates. So the large majority of our patients are on paid drug with low utilization of our free drug programs.
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Our valuing 23 grew by almost 160%. Reaching over 600 total prescriptions.
Speaker Change: This reflects both the growing pool of patients on OGMDAS and the high percentage of patients continuing on therapy.
Speaker Change: We've also been able to nearly double our prescribed-rebase in Q3 and about 80% of OGND subscribers have no experience with OGND prior to launch.
Additionally, we're seeing increased prescribed or comfort with OGEMDA with the number of HCPs with two or more patients on our drug continuing to increase.
The breath of patience receiving Ojanda is also notable.
Since launch, we've had significant uptake in treating both patients with BRF fusions and mutations, and with patients who have tumors that span the spectrum of locations for PLGG.
Speaker Change: We believe this broad applicability reinforces the value proposition of OGEMDA in the treatment of relapse refractory PLGG patient.
As we analyze our data, we're seeing early signs of increasing use in second and third line therapy.
This is consistent with our expectations that as physicians gain greater confidence with Ojanda, they will move it earlier in their treatment paradigm.
Feedback from customers has been overwhelmingly positive regarding OGMDIS product profile, our patient support programs, and the overall ease of access to the medicine.
However, we recognize that it will take time to fully penetrate this market, due to the slower progression rate of this disease and the relative infrequency of treatment decision.
Through our efforts we continue to build momentum for OGMDUF and we see evidence of this in our market research as well as our sales result.
In a recent survey of 24 PLGG treatars, 100% of them were aware of OGMDA and over 90% of them intended to prescribe it.
This is up from 64% from a larger survey done around March.
Additionally, when we look at the top tier of accounts that treat the highest volume of PLGG patients, over 80% have started one or more patients on OGMDU.
On the right, we've included a few quotes from our customers highlighting their belief in our product profile, and how they are evolving their treatment paradigm to incorporate OGMDA.
In addition to making progress with physicians, in Q3, we also made substantial progress establishing published payer coverage.
Since early in our launch, we've seen high-payer approval rates, which are now about 80% across all payers.
This has enabled us to have a high percentage of patients on paved drug.
Speaker Change: It's also important that we establish published coverage, because that will reduce the number of patients who need to navigate and appeals process with their payer.
We made a tremendous amount of progress on this front-to-scorer, increasing Medicaid coverage by 17% and commercial coverage by 48%.
We can now say that the majority of patients have established coverage for OGMDUF with 62% of commercial and 67% of Medicaid patients having published coverage.
As we look ahead to two four, we continue to focus on the fundamental level drive our business.
We must continue to grow the breath and depths of our prescribed base.
Position Ojenda as the standard of care in second line treatment.
And if you're a pair coverage policy for the remaining patients who do not have coverage today.
Speaker Change: We're excited about the progress we've been able to make in the first five months of launch, but this is just the beginning.
Speaker Change: We continue to see considerable potential in this market, and we are highly motivated by the continued interest and excitement from our customers.
Now, for more details on our financials, I'll turn it over to Charles.
Hello everyone.
Earlier today we reported detailed third quarter 2024 financial results in our earnings release. These results highlight our continued focus and value creation.
As Lauren mentioned, we have experienced strong patient demand for a gym distance launch, resulting in day one recording $20.1 million of a gym to net product revenue in the third quarter, our first full quarter of revenue.
Our Q3 results bring our year to date in that product revenue to $28.3 million for 2024.
Additionally, we close two transactions, a license that are at XUS commercial rights for Tova Raffinib and an equity financing. Both of which resulted in over $280 million of incremental capital for day one's future development.
As we announced in July, we licensed our X-US commercial rights to overreaffinive to ifst and for up front cash.
Speaker Change: Future milestone in royalty payments, as well as an equity investment made at a market premium. As a result of that transaction, we recorded $73.7 million of the license revenue in the third quarter of 2024.
Speaker Change: It is important to note that an incremental $4.5 million of licensed revenue will be recorded over the coming years.
In a partnership such as ours of Bipsen, US GAF requires deferral and subsequent recognition of the allocated transaction price for the future R&D services day one is contractually obligated to perform.
1 minor variability is expected. We believe the recognized license revenue will be approximately $3 to $500,000 per quarter.
Cost of sales for the current quarter includes intangible amortization of sales based royalties.
As stated last quarter, we expect cost of sales to increase to 9-12% of net product revenue. Early next year, as the sale of post-approval cost of inventory commences.
Our total operating expenses were $64.1 million for the current border compared to $51.4 million in the same quarter last year.
This increased relative to the third quarter of 2023, with driven primarily by commercial investments supported the U.S. Law on to agenda.
At day one, we continue to approach capital allocation in a discipline manner.
We have a clear and focused operating plan, and when paired with our strong cash position of 558.4 million dollars, we are well funded for measured investment in expanding our pipeline and for continued investment in clinical development, for our multiple programs.
Speaker Change: Thank you, closing. Our chief and student is 3rd quarter of 2024 represented important steps in day once path to transformation to a commercially sustainable company, with a gem that's serving as a foundation of value and grip.
These events included in role-making our frontline PLGG trial for Ruge Mda.
Day 3-1, our PTK 7-target at ADC is nearing the clinic in the US. And we took multiple steps to successfully strengthen our balance sheet.
We will finish the year strong with continued urgency and continued focus on delivering new medicines.
Now, we'll turn it over to the operator for Q&A.
Speaker Change: Thank you.
For the Q&A section of the call, we ask that all participants limit their question to one with an opportunity to have one follow-up question.
We will now open the line for questions.
If you would like to ask a question, please press star and then one now.
A confirmation tone will indicate your line is in the question q. You may press star and then two, if you would like to remove yourself from the question q. Again, if you would like to ask a question, please press star and then one now.
The first question that we have comes from unopalmerama of JP Morgan. Please go ahead.
Speaker Change: Hey guys, thanks so much for taking the question and congrats on the quarter. Just a quick logistical question. I think you noted around 2 million of inventory and 2Q. Maybe you can comment on what you're seeing in terms of inventory levels in 3Q and how we should think about that going forward. Thanks so much.
Thanks on a promise to Jeremy. I appreciate your joining and the question. Let me ask Charles to comment on the inventory topic.
So, Anapom from our perspective
As we look forward, it was, as we look back, rather, it was important for us to provide the level of Channel stock in the first quarter of revenue for us, so in Q2 of 2024, given the fact that there is stocking inventory as as commensurate our distribution model.
Speaker Change: In that quarter and going forward, what we will discuss is that the similar guidance that we provided, which is approximately two to four weeks of Channel Stock on Hand.
And when we look at that, that really...
Translate into continued inventory, a continue channel stock at the special pharmacies, but something that is not contributing materially to our overall revenue. We will not provide the individual number any further would just provide some guidance if we're off that two to four week of channel stock on hand.
Thank you so much for taking that question.
Thank you. The next question we have comes from Joe, Catherine Zaro, Oct. Piper Sandlow. Please go ahead.
Hey everybody, I'm appreciate you taking my question and correct that the night's court here. Just wondering, maybe if you could.
Sort of elaborate a little bit more on the cadence of new patient starts, whether what you saw in 3-2 was sort of in line with what you observed in may or June, whether there are maybe still.
Speaker Change: sort of early launch factors that play here, or you believe what you're saw on 3Q, we'll continue for the foreseeable future moving forward. Thanks.
Speaker Change: Thanks, Joe, for the question. Let me comment then I'll ask Lauren to add any detail. What we saw in the third quarter is a very consistent with what we did in the second quarter and that is continued and consistent.
Adds in terms of new patients and that is the pattern that we expect going forward. We did not see any substantive change in that pattern in the third quarter relative to our launch quarter, which was the second.
Speaker Change: Yes, we continue to hear from physicians that there are
Speaker Change: patients.
They're treating today that have potential to go on a gym in the future. So we do believe there continues to be a lot of potential for the product to be used in more patients in the future.
Okay, got it. That's helpful. And then if I could just ask one quick follow up, I get a technical question. So the TRX number that you're mentioning here is it fair to assume that each TRX is one month of drug supplier. They're script-speanwritten for longer terms of
Let me ask Warren to answer that.
Warren: Yes, a TRX is roughly 28 days supply. The only exception would be for a quick start patient getting a second shipment. It's only two weeks and that would count as a TRX. But we have very few patients leveraging our quick start program at this point since we have such high pay or approval rates.
Okay, great. That's helpful. Thanks again for taking my question.
Thank you.
The next question we have, come from Andrea Newcock of Goldman Sachs. Please go ahead.
Hi everyone. Thanks for taking the question. More in could you just clarify the number of patients that you do have on drug currently I think as of QQ is 157 and maybe the breakdown there for EAP versus Dinovo.
And then just really quickly what person education from that to to cohort did continue on treatment and three to. Thank you so much.
Thank you for the question.
So we're not providing specific numbers. What I can say is that we provided the breakdown in Q2 between EAP and new patient starts. So that is the same.
There were an additional 3 EAP patients that we transitioned in Q3 and now EAP transition is completed. So all the other new patients starts are Dinovo, new patients starts.
in Q3 and the TRX numbers represent the refill prescriptions from patients continuing from Q2 as well as any prescriptions from the patients starting in Q3, both their initial script and any resills.
Speaker Change: And so TRX will be what we plan to provide moving forward.
Speaker Change: Okay, thank you. And then just, you mentioned the high continuation rate. Are you giving a, maybe a number to that? If possible.
Yes, we've been really pleased with the continuation rate for PLGG patients. So we see the discontinuations, you know, five months into launch is in the low single digits.
Speaker Change: Yeah, Andrew, let me add to that.
That we're observing in the commercial setting, what we very much would expect to, based on the data that have been generated in Firefly 1, where you saw persistent treatment and long durations of treatment, it at least so far in the launch. And nothing has really diverged from that expected pattern at the stage.
Speaker Change: The World
Thank you.
Ladies and gentlemen, just your reminder, if you would like to ask a question, please first, star, and then one now.
The next question that we have, come to a submit right or Jones research. Please go ahead.
Congratulations everyone on the great solid quarter. What question if you are seeing any, getting any comments on the community setting positions, what kind of traction you are getting there or any resistance in terms of they want to see a longer duration on drug before getting in?
I'm sure I'm at thanks for the question, Lauren, if you could answer that one.
Yes, we've seen significant uptake both in academic as well as community physicians.
Lauren: And, you know...
Some physicians had experienced prior to launch through clinical trials in EAP. But when we look at our total prescribed report, 80% of them had no experience prior to longs and large numbers, those are in the community setting.
So we haven't heard any resistance in the community setting. Although then obviously many of them are managing a smaller population of patients so they may have less frequent opportunities to make a treatment decision. But other than that we've seen uptake in both academic and community.
Thank you for that. And one quick question on the front line some trials. Are you getting patients if you can comment? Are you getting patients any?
Post-Macon Hiviter after surgery are you are seeing physicians equally easier and enrollment hindrance coming from physicians putting Macon Hiviter's post-surgery and before or to overachnome.
Let me hand to Sam for that one. Thanks for the question. The frontline trial is for patients who need their first systemic therapy. So it's not possible for patients to get a mechanic inhibitor or a total of than to be in the frontline trial.
There will be patients who are enrolled after surgery and then there will be patients who are surgically and elderly who enrolled as their first treatment.
Speaker Change: Thank you so much.
The next question we have comes from Alex Strattonahan of Bank of America. Please go ahead.
Hey guys, thanks for taking my questions to from me as well. Maybe first, just to quick follow up on the cadence of new patients, starts in 3Q. Curious weather, patients that as were fairly linear during the quarter, maybe.
Speaker Change: I'm using all lumpiness during this summer, any additional color you can add on the cadence of new patient ad.
Speaker Change: Alex, thanks for the question. The cadence, what we can say is that the cadence was.
A very consistent, we didn't observe any significant seasonality. So it was really very straightforward. And that's been true for both the second quarter, the post-launch quarter, as well as this first full quarter.
Okay, thanks, Jeremy. Make sense. And maybe just to follow up, you know, given the new duration of response today, you've shown from Firefly 1.
Speaker Change: I'm wondering how you're thinking about this 18-month translating to the real world, maybe anything you can say on, types of patients are treating currently versus the clinical study in any feedback you've been getting from the field would be great. Thanks.
So first, let me comment on the new data that we did provide. You know, the first is that
We've seen duration of treatment data that we disclosed in the second quarter results of just under 24 months. And then the new data point that we disclosed in our release today is a duration of response.
data sets. And let me ask Sam to comment first and then in the other team.
Yeah, thanks Alex, just a comment from the clinical side. I think that the updated duration of response data.
You know, ultimately, you know, it's going to give confidence to prescribers that the responses that we're seeing are increasingly durable.
At the end of the day, the duration of treatment is not necessarily linked to
The radiographic response, and I think as we've discussed multiple times
You know, small changes in the size of the tumor which may on a clinical trial.
to lineate or be indicative of radiographic progression by standardized response, the Cestran criteria.
Speaker Change: isn't necessarily a trigger or physicians to stop or change treatment. And as we've said multiple times before, pediatric neurologist's treat patients, they don't treat scans.
So, at the end of the day, I don't think that this changes the duration of treatment, but what it does do, or the decision around duration of treatment, but what it does do is give, I think, a great deal of confidence that the response that we're seeing are really remarkably remarkably durable.
Great, thank you and congrats on the progress.
Speaker Change: Thanks Alex.
Speaker Change: Next question we have come from Almyh Fadiak of Needem and Company. Please go ahead.
I'm Greg Ling, thanks for taking my question.
It would be helpful if you could give us some color on.
The number of patients that are on treatment, the way I was sort of doing the math based on.
The 600 descriptions, you know, assuming that all of the 150 seven from last quarter had a three-square speech, that gives us to 471 leaving 129 scripts and if you use the human average of one and a half months, that's...
Bring us to about 86 patients added in the quarter.
Does that match roughly kind of a line with what you guys are saying?
I'm going to ask you a question. As Lauren noted, we're not focused on the disclosure of specific patient numbers quarter by quarter.
So I will comment specifically on the numbers that you arrive at.
Our focus really is on driving.
Overall, commercial performance and what I would reiterate is that the pattern that we observed in terms of the addition of new patients in the third quarter was very consistent.
Throughout that quarter and indicates, you know, continued demand at a steady pace.
Speaker Change: And then maybe just a quick one on day 301. You're getting ready to start those in patients or actually just start those in patients.
Can you just give us a high level sense of what type of data could we expect to see next year? Thank you.
I mean, yeah, we are a poise to start that trial and those the first patient. You know, relatively soon, I would reiterate our guidance here that that will occur in Q4 or early Q1. And, you know, we're very much on track for that that starts.
We have not specifically guided to when we'll have any early data from the phase 1 portion of that trial.
Speaker Change: As you can imagine that will depend on a number of factors. We do think there will be a lot of interest in the trial and that will move quickly.
Speaker Change: That being said, it isn't clear yet whether we'll have any specific data that will be
A published or available in 25. So we'll have to come back to that question and provide more detail on when those data may be available in subsequent quarters.
And Mr. Thank you so much
Speaker Change: Thank you, Army.
Ladies and gentlemen, just a final reminder, if you would like to ask a question, please press star and then one now.
Speaker Change: The next question we have, come from address Maldonado of ATWA in right. Please go ahead.
Hi guys from Gretz in the quarter and thank you for taking my questions. Maybe just two quick ones for me. The first one, looking prospectively at the collaboration with Itz, and now what is the impression it is?
Speaker Change: given you on some of the differences of launching a RAP inhibitor in the US versus the EU. And it's there to improve RAP inhibitor in both scenarios where we could use as a reference point to set our expectations there.
Speaker Change: And then the last question on the PT-T7, obviously competitors have generated intriguing signals across a marietta tumor types. Here's some books that's sinking towards.
You know, combination work here and how much pre-clodical work has been done there. That and your strategy moving forward. Thank you very much.
Speaker Change: I'm sorry to say the question. Let me start with your question about it. There are outside of the U.S. and in the U.S. of course.
A number of wrath inhibitors that are type 1 wrath inhibitors that have been approved.
You know, those are really limited to adults with disease driven by, you know, predominantly B600 E mutations in their tumors.
And those have been around for some time. I don't remember the specific initial approval there.
But those are distinct from OGMD as approval here in the U.S. So, GEMD is a type 2, a RAF inhibitor, and a unique mechanism of action for that reason, albeit against.
Speaker Change: A similar target.
In terms of the discussions that we've had with Epson, we can't really talk in detail about the nature of those. What I can tell you is that.
We have very clear alignment on the registration strategy for OGMDA in markets outside of the US and confidence in.
Speaker Change: Ifsen's ability to achieve those approvals and are well on the way towards supporting their efforts for submission.
With respect to your second question about PTK-7 and potential combinations, I'm going to make one comment and then hand to Sam for a little nuance.
You know, from my perspective, one of the features of that specific program.
Is that we can pursue through a phase one, one B and phase two cohort expansion strategy.
You know, clear signal-seeking work that will allow us to understand.
The potential registration paths for that program across
A fairly sizable number of tumors, because we have the potential for single agent. Activity.
Speaker Change: That, of course, does not address the longer-term question of whether those registration paths could involve combinations, which, of course, many of them may. For that, let me hand to Sam to talk to the more detail.
Thank you. Thanks, it's a thought-pull question. Just to build on what Jeremy said, our development plan, and I think I don't want to speak for all my colleagues in drug development who are working on EDC's, but having worked in the space for it, I think all the share of this common belief.
Speaker Change: That, you know, a well-designed, well-targeted ADC is going to be active as monotherapy in our early Phase Development Programis Design to a listen to monotherapy signal and activity. If you look at the history of ADC development,
combination work has taken place and certainly in bladder cancer with important meth video and in combination with the checkpoint inhibitor.
But that was really subsequent to the approval of that as monotherapy. I think for us, the most important thing is for us to be laser-focused on eliciting a monotherapy signal as such.
Designed a very efficient
Speaker Change: phase 1 clinical trial and look forward to bringing the same type of high-quality execution to it that we brought to.
Speaker Change: our work in low-break Lyoma and you know we'll do, you know, I think all due diligence on potential combinations for later stage fumb and should have been necessary but again, this next year is really about highly efficient execution of our Phase 1 trial.
Speaker Change: Thank you very much.
Thanks, Anders.
Thank you. Ladies and gentlemen, we have reached the end of our conference call. Thank you for joining us. You may now disconnect your line.
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