Q4 2024 UroGen Pharma Ltd Earnings Call
Thank you for watching!
Dr. Raghuram Selvaraju, Dr. Raghuram Selvaraju
By Kaplan Meier analysis. The median follow up time for these patients has now extended to $18 seven months. After three months CR up from $13 eight months at the previous data cut and the median duration of response is still not reached.
We have provided these data to the FDA and our 120 day update and they will be part of the submission.
The durability of response is critical for a disease with historically high recurrence rate by extending disease free periods, usually in one or two has the potential to increase disease and treatment free intervals, which are associated with morbidity and quality of life challenges in this population.
We engaged with the FDA in a productive mid cycle review meeting this past week. The agency confirmed they will be referring the NDA to oded.
Previously indicated the meeting will take place in May and we are awaiting official publication of the meeting date in the federal registry.
We are aligned with the agency that the Advisory Committee presentations and materials were focused on the recurrent patient population.
<unk> in the envision trial, therefore, we believe that Eugene and one or two if approved will be indicated in the recurrent patient population. It is important to highlight that our data in this population is highly supportive and this group represents the vast majority of the overall revenue opportunity.
These meetings are confidential and theres a limit to what we can share today I want to take this opportunity to reaffirm our confidence in the strength of the data package, we have submitted and in the potential of <unk> in one or two to address the significant unmet need for patients.
We remain fully focused on preparing for <unk> and look forward to the opportunity to present, our compelling data to the advisory committee and engage with the broader medical community if approved new GM, one or two will become the first medicine for this patient population introducing a potentially paradigm shifting solution for this.
Disease.
And a profile and museum, one or two will be transformative for <unk> as it represents a significant market opportunity a population nearly 10 times larger than the market for John <unk>.
This translates to a total addressable market of more than $5 billion.
Accordingly, our ability to identify and target physicians and their patients for UGI and one or two will be easier.
Unlike low grade upper tract, <unk> carcinoma, which is a dispersed rare disease low grade intermediate risk non muscle invasive bladder cancer is widespread and managed by nearly all urologists.
Eugene and one or two is designed for seamless integration into outpatient practice workflows.
He is abused creates the opportunity for physicians to expand their practices and enhance patient care.
<unk> generated net product revenues of $94 million for the full year 2024, compared to $82 7 million for the prior year the increase of $7 $7 million year over year was primarily driven by increased underlying demand for job might have partially all.
Offset by a decrease in creates act cells and an increase in 340 <unk> charge backs, if we focus on actual underlying product demand.
<unk> grew by approximately 12% year over year.
Our commercial team recognized that this is a high touch product. So we have been focused on increasing our reach and frequency with key accounts.
This has resulted in consistent improvement across several key metrics, including overall volume patient enrollment forms and new patient starts new script writers and new sites of care.
In Q4 of 2024, we saw our highest ever number of demand units, David Lamb will provide more details in his update.
We have also made great progress in advancing our long term growth strategy with the recent acquisition of ICB 10, 42 from iconic beer. This next generation investigational oncologic virus represents an exciting opportunity in cancer care.
With its unique mechanism ICB $10 42 is designed to selectively target and destroy tumor cells without compromising its lytic activity is.
It's designed to enter a broad spectrum of tumor cells, allowing it to potentially treat a wide range of tumor types.
This acquisition aligns with our vision and strategic focus to develop innovative therapies to address critical gaps in cancer care.
For those interested a replay of our investor webinar announcing the acquisition is available on our website.
Your June ended 2024, with a strong balance sheet holding $241 $7 million in cash cash equivalents and marketable securities we remain well capitalized to execute our operating plan and advance the company to and through profitability with anticipated law.
Speaker Change: Launch of new GM, one or two later this year I will now turn the call over to Mark Schoenberg, Chief Medical Officer for a clinical update Mark.
Mark Schoenberg: Thank you Liz beginning with the NDA for <unk> 102, our clinical and regulatory teams are fully engaged in preparing for the <unk> meeting, where Eugene one or two will be reviewed as a potential paradigm shift in the treatment of low grade intermediate risk non muscle invasive bladder cancer.
Mark Schoenberg: We believe a key consideration for the FDA is that Eugene and one or two represents a fundamental change in how we approach this disease moving away from repetitive surgical procedures that have been the standard for decades, we feel confident heading into this discussion urologists appreciate the need for alternative treatment options that could potentially.
Mark Schoenberg: We provide a longer treatment and recurrence free survival in Eugene and one or two has the potential to fill this gap offering office space administration that aligns with the way urologist practice.
Mark Schoenberg: Body of clinical evidence supporting new Gen, one or two continues to grow.
Mark Schoenberg: <unk> highlighted the latest duration of response data from envision showing an impressive 88, 6% duration of response at 18 months for those patients who had achieved a complete response at three months.
Mark Schoenberg: We will continue to follow these patients.
Mark Schoenberg: Current data represent a potentially significant advance for patients as we have not reached the median duration of response, we continue to appropriately engage with the broader medical community to share our clinical findings from envision.
Mark Schoenberg: The envision trial results were recently published in the February print edition of the journal of Urology and were also presented at the society of Urologic oncology or <unk> annual meeting, which took place in Dallas in December.
Speaker Change: I'd suo, we also had the opportunity to present long term follow up data from the Olympus trial, which demonstrated a median duration of response of approximately four years in patients who had achieved a complete response with <unk>.
Speaker Change: These data further reinforced <unk> role as a primary treatment for low grade upper tract, <unk> cancer, providing patients with a meaningful alternative to surgery.
Speaker Change: In January previously announced results from the real World Post commercialization study of <unk> were published in Urologic oncology. This long term study evaluated 56 patients from 15 high volume centers, we achieved complete responses with <unk>, demonstrating a recurrence free survival rate of 68.
Speaker Change: Percent of three years.
Speaker Change: Notably recurrence free survival was consistent irrespective of tumor size location number of tumors and routed administration with no difference between primary chemo ablation and as adjuvant therapy post endoscopic ablation. These findings further support the use of <unk> in a broad pay.
Speaker Change: <unk> population.
Speaker Change: Turning now to the pipeline, we have a comprehensive lifecycle management plan for <unk> and <unk> 102 enrollment continues in the phase III Utopia trial, which is evaluating <unk> 103, our next generation product for low grade intermediate risk and <unk> <unk>.
Speaker Change: Utopia as a single arm Multicenter study with the protocol similar to the envision trial.
Speaker Change: Low grade intermediate risk disease patients with recurrent disease are receiving <unk> 103 via intra vesicle installation once a week for six weeks efficacy will be assessed based on the complete response rate at the three month, Mark and patients will be followed to evaluate durability of response.
Speaker Change: We expect to complete enrollment this year.
Speaker Change: Despite reporting topline data in 2026.
Speaker Change: A similar development plan for <unk> 104, our next generation formulation of <unk> and expect to commence a single arm phase III study in the first half of 2025.
Speaker Change: In February we were pleased to announce the acquisition of ICD $10 42, a next generation oncologic virus developed by icon of you. This addition, meaningfully enhances <unk> pipeline by introducing a highly innovative approach to selectively targeting and destroy cancer cells, while simultaneously activating a.
<unk> anti tumor immune response, $10 42 was thoughtfully engineered to achieve efficient cell entry strong selectivity for malignant cells and rapid replication within the tumor microenvironment features that drive both direct tumor cell lysis and the induction of a durable tumor specific immune response, our development plan.
Speaker Change: And for $10 42 is advancing with IND, enabling studies expected to begin this year, we intend to evaluate several modes of administration, including delivery using our proprietary <unk> technology.
Speaker Change: While our initial focus will be on bladder cancer, we anticipate exploring $10 40 twos potential to address a broader range of malignancies beyond the genital urinary space finally, Eurasia and will have a significant presence at this year's American Urology Association meeting to take place April 26 to 29 in Las Vegas, Nevada.
Speaker Change: This is an important conference for us and I'm pleased to say that we have six abstracts accepted. This year. These include a podium presentation of the envision trial results by Dr. Sandeep facade, the principal investigator of the Eugene and one or two trial.
David Lim: Now over to David Lim for a commercial update.
David Lim: Thank you Mark.
Speaker Change: Morning, everyone.
Speaker Change: I am pleased to provide an update on our commercial initiatives as we move closer to the <unk> target action date for UGI and 102.
Speaker Change: The upcoming launch with market pivotal moment in <unk> evolution from a rare disease focused company to a multi product specialty driven team.
Speaker Change: Our goal is to deliver a seamless and successful launch ensuring that our efforts translate into patient access to this potentially groundbreaking therapeutic option.
Speaker Change: Our immediate priority is continuing to execute our comprehensive pre commercial strategy that we believe will lay a strong foundation for widespread access and adoption of <unk> 102.
Speaker Change: We are confident in the strength of our clinical data and the potential it holds for patients with low grade intermediate risk non muscle invasive bladder cancer.
Speaker Change: We are focused on three key priorities and our preapproval preparation.
Speaker Change: First we are actively working to raise awareness about the unmet needs in low grade intermediate risk non muscle invasive bladder cancer through a variety of educational programs.
Speaker Change: Our medical affairs team is engaging in scientific exchange activities involving the clinical data supporting <unk> and 102.
Speaker Change: Next we continue to gather insights across key stakeholders, such as prescribers payers and patients in order to refine our launch plans of course, we'll leverage learnings we have gained through our experience with <unk>.
Speaker Change: And finally, we are scaling our commercial infrastructure and capabilities to ensure we're appropriately sized to fully address the opportunity for UGI and one or two if approved.
Speaker Change: We are significantly expanding our sales force from 52 reps today to approximately 83 at our anticipated launch.
Speaker Change: We are also building out our customer support capabilities to support a broader portfolio, particularly in our ability to provide comprehensive training and support for health care professionals and their staff.
Speaker Change: To ensure a seamless integration of <unk> into treatment protocols.
Speaker Change: Additionally, we are preparing our engagement initiatives to inform both clinical practices and patients about <unk> coverage options and reimbursement.
Speaker Change: While <unk> 102 will initially be assigned a miscellaneous J code for billing.
Speaker Change: We expect to secure a permanent J code by January 2026, which will be particularly important in the community setting.
Speaker Change: In the interim we are fully committed to offering strong reimbursement support to help providers navigate the coating process, helping to ensure the integration of <unk> and 102 is as smooth as possible.
Speaker Change: We are in the cusp of a truly exciting launch and we are energized by the opportunity to bring this investigational treatment to patients and continue making strides in the fight against bladder cancer.
Speaker Change: Turning to gem, Idaho, as Liz mentioned, the product delivered $87 $4 million in underlying demand revenue in 2024.
Speaker Change: An increase of 12% versus the prior year.
Speaker Change: Fourth quarter underlying demand revenues increased 15% year over year, and we saw consistent improvement across multiple key metrics.
Speaker Change: Demand units in Q4 were our highest ever up 15.
Speaker Change: Compared to Q4 of last year.
Speaker Change: New prescribers and new patient starts increased 33% and 13% respectively in 2024 compared to 2023.
Speaker Change: The recent clinical data and publications that mark referenced including the long term follow up from Olympus and positive results from the real World study.
Speaker Change: Further underscore the impressive durability of Joe might have these.
Speaker Change: These results continue to reinforce its important role in treating low grade upper tract European cancer.
Speaker Change: We are continuing our high tech strategy with a focused effort on key accounts.
Speaker Change: <unk> remains a key part of our commercial portfolio.
Speaker Change: As we expand our sales force in preparation for the <unk> in 100 to launch the new Representatives will also be promoting <unk>.
Speaker Change: This strategic increase in our sales team is designed to drive growth for both products enhancing our ability to support key accounts and maximize market impact.
Speaker Change: I will now turn the call over to Chris Degner to discuss our financials.
Chris Degner: Thank you David.
Speaker Change: Before I turn to our financial results I am pleased to report <unk> enter 2025 from a position of financial strength at.
At the close of 2024 cash cash equivalents and marketable securities totaled $241 $7 million.
Speaker Change: Providing a solid foundation to continue executing on our strategic initiatives with.
Speaker Change: With the anticipated launch of Eugene on one or two later this year, we are well equipped to drive our company towards profitability and create long term value for our shareholders.
Speaker Change: Turning now to our financial results.
Speaker Change: <unk> net product revenues.
Speaker Change: Were $24 6 million in the fourth quarter of 2024 compared to $23 5 million for the same period in 2023.
Speaker Change: Underlying demand revenue increased by 15%, partially offset by a decrease in creates act sales, which totaled <unk> $2 million in the fourth quarter of 2024 compared to $2 4 million for the same period in 2023.
Speaker Change: Joe <unk> net product revenues for the full year ended December 31, 2024 were $94 million compared with $82 $7 million of revenue in 2023.
Speaker Change: Research and development expenses for the fourth quarter of 2024 were $14 $9 million as compared to $11 3 million for the same period in 2023.
Speaker Change: R&D expenses for the full year 2024 were $57 1 million compared with $45 6 million for 2023.
Speaker Change: Year over year increase was primarily driven by manufacturing expenses for our product candidates regulatory expenses related to you Jan one or two and costs associated with the Eugene 103 Utopia trial.
Speaker Change: SG&A expenses for the fourth quarter of 2024 were $34 9 million compared to $24 6 million in the same period in 2023.
Speaker Change: For the full year 2020 for SG&A expenses were $121 $2 million compared with $93 $3 million in 2023.
Speaker Change: The year over year increase was primarily driven by Eugene one or two commercial preparation activities.
Speaker Change: We reported non cash financing expense related to the prepaid forward obligation to RTW investments of $6 1 million in the fourth quarter of 2024 compared to $5 $5 million in the same period in 2023.
Speaker Change: Non cash financing expense related to RTW investments was $23 $4 million in the full year 2024, compared with $21 $6 million in 2023.
Speaker Change: Interest expense related to the outstanding $125 million term loan facility with Pharmacon advisors was $3 9 million and $12 $5 million, respectively for the fourth quarter and full year 2024, compared with $3 6 million and $14 $7 million respectively.
Speaker Change: <unk> for the fourth quarter and full year 2023.
Speaker Change: Net loss was $37 5 million or <unk> 80 per basic and diluted share in the fourth quarter of 2024, compared with a net loss of $26 million or <unk> 72 per basic and diluted share in the same period in 2023.
Speaker Change: For the full year 2024, net loss was $126 9 million or $2 96 per basic and diluted share compared with a net loss of $102 2 million or $3 55 per basic and diluted share in 2023.
Speaker Change: Turning to forward guidance for 2025.
Speaker Change: The company expects full year 2025, Jo Mira revenues to be in the range of $94 million to $98 million.
Speaker Change: This implies a year over year growth rate of approximately 8% to 12% over the $87 $4 million and demand driven Jo Mira revenues in 2024, which excludes the $3 million and creates act sales reported in 2024.
Speaker Change: Full year 2025 operating expenses are expected to be in the range of $215 million to $225 million <unk>.
Speaker Change: Including noncash share based compensation expense of 11% to $14 million.
Speaker Change: The anticipated increase in full year operating expenses is primarily driven by the planned sales force expansion and additional commercial and medical activities to support the Eugene I wanted to launch as well as the investment of our huge yen one of three and Eugene one or four clinical programs.
Speaker Change: We are now ready to open the call for questions.
Speaker Change: Operator.
Speaker Change: Thank you to ask a question at this time. Please press star one on your telephone and wait for your name to be announced to withdraw. Your question. Please press star one again, one moment for our first question.
Karen Bancroft: And our first question is going to come from the line of Karen Bancroft with TD Cowen. Your line is open. Please go ahead.
Nick: Great. Thanks, This is Nick on for Tayo.
Nick: You noted on the call that you anticipate approval in the recurrent setting do you anticipate that your gen. One or two could still be used in about 10% of patients or so that are in eligible for surgery, which would be at the frontline setting and with this then required to be used off label. Thanks.
Nick: Hi, Nick.
Liz: It's Liz.
Speaker Change: I think that would be considered off label. So clearly we wouldn't be able to promote there and I think it would be up to the physician to work with their insurance company because thats really when it comes down to is really more of a.
Speaker Change: A situation of making sure that they can get paid for it so as we've talked about before we thought we actually thought they might go there. They did in the meeting and it was really driven by the fact that they always viewed that as being the unmet need.
Speaker Change: And it doesn't change our revenue projections that would be really clear about that so we still believe.
Speaker Change: Then the medicine.
Speaker Change: <unk> will be over $1 billion revenue.
Speaker Change: <unk>.
Speaker Change: And that doesn't change that and never data is more about exactly what you're talking about like we want physicians to have the ability for those few patients that they really don't want to put under because we all know that the newly diagnosed patients almost all of them get it <unk> for diagnostic purposes, but there are a handful of patients that.
Speaker Change: <unk> would just prefer not to put under Mark can comment I think about what would happen. They usually do it anyway, right and it's a little bit more risky, but and physicians have told us they would like they would like to be able to make that choice and not and not the FDA, but.
It was clear in the conversation that we had with them.
Speaker Change: We had discussed it internally and knew that if they did go there it's better for US frankly to go into the <unk> aligned with them on that so that we don't spend time in the <unk>.
Speaker Change: Going back and forth on that and that we also don't risk.
Speaker Change: Vote, because negative vote because.
Speaker Change: Panelists say, well I don't want that newly diagnosed.
Speaker Change: This obviously makes it.
Speaker Change: While our patient population, but not really smaller.
Speaker Change: Our business opportunity, but to your point it would be up to the position to work with the payer and the patient for them to get reimbursed and we're obviously all we also.
Speaker Change: Think about whether we should do some some clinical work in this space or not but it's a very small financial opportunity again, just a matter of being able to help physicians make it easier for them to use.
Speaker Change: That's very clear thank you very much.
Speaker Change: Thank you and one moment for our next question.
Speaker Change: Our next question will be coming from the line of Michael Schmidt with Guggenheim. Your line is open. Please go ahead.
Michael Schmidt: Hey, good morning, Thanks for taking our questions.
Michael Schmidt: On Jan one or two as you think about the potential FDA approval later this summer in June.
Michael Schmidt: How should investors think about the initial launch trajectory.
Michael Schmidt: Perhaps relative to <unk> or other potential benchmarks.
Michael Schmidt: Are there any any analogs that we should look at.
Michael Schmidt: And then how should we think about pricing again of one or two relative to John Mito and would you expect any meaningful channel inventory built earlier this.
Michael Schmidt: Each year.
Michael Schmidt: Alright, Thanks for the question I'll turn it over to David <unk>, Our Chief commercial officer to answer those questions David.
Michael Schmidt: Yes. Thanks for the question in terms of launch trajectory.
Michael Schmidt: We intend to.
Michael Schmidt: Mentioned, we're going to continue educating our physician provider universe.
Michael Schmidt: Obviously, maintaining a lot of support so the way we're thinking about the overall shape of the curve is very akin to how we thought about Joe might go wild.
Michael Schmidt: While the numbers the absolute numbers would be larger because of the patient patient population.
Michael Schmidt: Overall shape.
Michael Schmidt: Modeling very similar to that of Jo mill, because theres a lot of similarities in terms of the operational considerations.
Michael Schmidt: On your question with regard to pricing I think we've been we continue to think of pricing in the 18 to $19000 per dose.
Michael Schmidt: However, we continue to do research with payers to refine our assumptions.
Michael Schmidt: That's how we're thinking about it for right now.
Michael Schmidt: Great. Thank you. Thank you.
Speaker Change: Thank you one moment as we move on to the next question.
Speaker Change: Our next question is going to come from the line of Gregory.
Gregory Silver: Silver <unk> with C. H H C. Wainwright. Your line is open. Please go ahead.
Gregory Silver: Thanks, so much for taking our questions firstly with respect to Eugene on one or two and the projected reimbursement environment. I was just wondering if you could maybe provide us with additional granularity regarding the difference in reimbursement level and degree of market access that you expect to have during the period immediately after the <unk>.
Gregory Silver: Launch when Youll have the generic J code and once you actually have a specific J code in January of 2020, just kind of spell out for us how the environment is going to change when you shift from one J code to another and then secondly, with regard to the pipeline development activities can you give us some update on how enrollment kinetics.
Gregory Silver: So appear to be progressing in the <unk> 103 program and if you still expect to be in a position.
Speaker Change: To report data from that trial, either next year or in 2027. Thank you.
Speaker Change: Yes, great question, So I'll ask David to answer the first question around reimbursement and then moved to Mark to give you an update on <unk> three and timing so David.
David: Yes. Thanks again for the question there from a reimbursement perspective as we stated in the initial six months assuming the June 13th.
Action date, we do anticipate a miscellaneous J code being used essentially what this means from an assumption standpoint is that the overall reimbursement process. We believe takes a little bit longer so somewhere around the 50 days to 60 days for a provider to be.
David: Reimbursed and that number does cut down by about half when we have a unique permanent miscellaneous J code, which we assume will be in the January 2026 timeframe. So our real focus is going to be making sure that we are with our accounts supporting them in the coding and reimbursement process to guide them through that initial pick.
David: <unk>.
David: And so we will continue to provide the same level of support as we are now just to a broader audience.
Speaker Change: Well, let me I just wanted to add a couple of things.
David: We all have services.
David: To get physicians through that time period. So like we did with John <unk> will have a longer dating so they don't have to put the money out before they get reimbursed as well as the hub and the other thing that I'll comment on is we also expect like we saw with <unk> that the initial uptake from our site of care perspective will be.
David: More in the hospital and the institutions.
David: The pharmacy takes the risk at that point in time and not.
David: The private practice so.
David: The J code.
David: More challenging as really the private practices, who are concerned about putting out that kind of money in taking the risk of not being reimbursed. So we expect those physicians, but just take their patient to the hospital or the institution in which they are affiliated in they would they would conduct the.
David: The therapy at that place so again as we.
David: We mentioned earlier as David mentioned earlier I think you can look at John <unk> in the initial couple of first 18 months I would not look at Yamato post those 18 months, because we do believe that that.
David: The opportunity is far greater for <unk> 102, and we should see an acceleration that's greater than that.
David: Then we see with <unk>, but the first couple of years, if John <unk> see in our first year, we sold 15 mill Brown the same six months.
David: Almost $15 million in revenue and then it went up to almost $50 million in the second and the full year following so.
David: Could you use that as a good analog for the first 18 months, so hopefully that helps.
David: Well, what I would also mention of course is for those who remember you launched Jo Mira in the middle of a pandemic would not be the case with 102.
David: Xactly, absolutely, but if you just take into consideration and I'm not suggesting the same amount of revenue but.
David: David's point earlier, it's a much bigger patient population the price may be a little bit less but but you can you can see at 10 times the size, even if Joe might award.
David: Analog or will it still be a very positive for the first few months.
<unk> of the launch, but Youre, absolutely right, we launched into a pandemic and hopefully knock on wood, everybody, we won't be having a pandemic in 'twenty.
Mark Schoenberg: 2025, and 2026, so thanks for the question and the comment as well and then I'll turn it over to Mark to answer the question I wanted to remark.
Mark Schoenberg: Thanks Louis.
Mark Schoenberg: With respect to one of three and the trial is the Utopia trial.
Mark Schoenberg: We are anticipating complete enrollment this year data in 2006 that approval in 2007. So it is sort of a lock step progression, but things are going well and we're very optimistic that we're going be able to keep at that timeline.
Mark Schoenberg: Thank you very much.
Thank you and one moment as we move on to the next question.
Speaker Change: And our next question is going to come from the line of Lee Linger Shaw with Oppenheimer. Your line is open. Please go ahead.
Speaker Change: Good morning, and thanks for the update and taking our questions just to.
Speaker Change: One from us.
Speaker Change: Just just keying off the earlier question about examining.
Speaker Change: <unk> been naive patients with low grade.
Speaker Change: Just wondering if you could given the ongoing trial with 103, if you would look to possibly amend that or if you would look to do further study.
Speaker Change: In treatment naive for the benefit of under three eventual label. Thank you.
Speaker Change: Yes, it's a great question Leland and to be honest with you. This has happened last week. So we havent spent a lot of time thinking about it I think at the end of the day.
Speaker Change: It would more likely be around generating data and real world use maybe like a registry or through an IR.
Speaker Change: But because as I mentioned the opportunity it's fairly small although the good news with <unk> III is that we would be moving to.
Speaker Change: Yes.
Speaker Change: Our patent protection on that that medicine will be until through 2041. So we have a lot of time. So I think we would take a look at it but no we would not amend the current 103 and the reason we would not in mens.
Speaker Change: 103 is because we need to keep that study is close to <unk> as possible. So that because that's what they'll be using as a comparison right. So to get that drug approved and approved quickly they'll be using <unk> in one or two so you want to keep that study as quickly as possible, but we will evaluate Eugene one of three.
Speaker Change: Just like we've been talking about.
Three into high grade disease, we will look at other areas, where we can study <unk> three there may be other populations and it may be not just in the newly diagnosed intermediate risk, but there may be a population the unwilling and unable population, which is actually broader than just the intermediate risk and that's something that I've been.
Speaker Change: Wanting to do for the last few years. So maybe we take an opportunity to do that and that would include newly diagnosed across a broader spectrum of patients.
Speaker Change: Yes, physicians just don't want to our patients don't want to go to surgery, but it's a great question will have to give it some more thought from that perspective.
Speaker Change: Thanks Scott.
Speaker Change: Slip in a quick second just in terms of the pipeline.
Speaker Change: Following the recent update on ICD would be.
Speaker Change: 100, 242, and other collaborative agreement I'm, just wondering if you have any plans to share more.
Speaker Change: They're either data or more and more about the collaborations in 2025 and also 301, you might see more reveal from that ongoing development. Thank you yeah. Great question on the collaborations I think we will wait till we see some data some feasibility data. These early studies.
Mark Schoenberg: They're really the first question is can you put the drug in the gel does it work does it does it provide the benefit and we think it does so we will do some some preclinical work there, but absolutely if that moves forward, we will share that and then Mark do you just want to give an update on what we expect that we'll see this year for <unk> hundred one and $2 42.
Speaker Change: Two.
Mark Schoenberg: Yes. Thanks, so with respect to 10 42 this year as IND, enabling studies. So we will be focused on that formulation et cetera.
Speaker Change: Obviously, we have notable.
Speaker Change: Output from that we would share that.
Speaker Change: That it will probably be next year before we have substance of data this year and it's early in that program with respect to 301, we did announce the monotherapy data yes, you over this past year, we actually as everyone knows have combination arms in that trial, which is a phase <unk> trial, combining 301 with our telos $7.
Speaker Change: It is 201 as well as with Gemcitabine, we have seen some interesting data with respect to responses again, it's a phase one trial, but we are following those patients for the durability of those responses and anticipate reporting that later this year.
Speaker Change: Super Thanks very much.
Speaker Change: Thank you and one moment as we move on to the next question.
Speaker Change: Our next question is going to come from the line of Paul Choi with Goldman Sachs. Your line is open. Please go ahead.
Paul Choi: Hi, Thank you good morning, and thanks for taking our questions.
Paul Choi: I wanted to revisit pricing for one or two for a moment and just wanted to ask given the.
Paul Choi: Impressive durability that envision data has shown relative to the total all in cost for repeat terabytes.
Paul Choi: Have you sort of stress test, maybe potentially higher pricing just sort of your thoughts payer reactions on this four for one or two here just again, given the durability and potential longer term rate reduction in costs any color there would be great.
Paul Choi: And second with one to three potentially launching as early as 2027 can you comment on how youre thinking about.
Paul Choi: Positioning 102 versus 103 would there be a switch strategy or would you just sort of sort.
Paul Choi: Fade out one or two in favor 103, given the longer IP considerations, there and just how youre thinking about the potential.
Paul Choi: Potential return on one or two if you do think about a switch strategy. Thank you very much.
Paul Choi: Great questions, Paul and I can tell you that we are revisiting we had already there's there is research underway because their pricing research. We had done was before that impressive.
Paul Choi: Data to you or to your point durability data. So we are looking at that and we do believe that there is an opportunity.
Paul Choi: To increase that slightly so we will definitely be looking at that and I'm sorry. Your second question remind me again.
Les: Yes sure Les.
Les: How youre thinking about positioning 103 versus one two apart from IP and just are you going to fade out one or two out.
Les: Just how do you think about the potential return profile for one or two if you do switch to one out of three yes, no absolutely sorry, but yes. We would do is we would as soon as one of the three is approved we would likely wait for the J code right ticket. So theres no concern about reimbursement, but then after that we would actually fade out Eugene.
Les: On our Q and we would take your GM, one or two off the market and shift all of that.
The <unk>.
Les: The business <unk>, three and that would that provides US is there is that one or two won't be on the market. So there won't be any automatic substitution or there won't be an interchange ability. So if generic or someone came in a post 2031.
Les: Would actually have to promote the product and the doctor would actually have to write for their specific products. So it wouldn't be a one or two for them to write in.
Les: Again it be interchange helpful. In addition to that I don't know if anyone saw but we had the product specific guidance came out in November around Yamato.
Les: The guidance says that they have to demonstrate that it is identical not equivalent but identical and I think that raises the bar for anyone to come in regardless of whether 100 twos on the market or not and we're obviously just shifting the information that we have <unk> because <unk> is the only one.
Les: Now that the generics have obviously since <unk> been on the market, but again why don't you would not be.
Les: But would not be on the market for the generic companies to be able to compare it to.
Les: So I hope that helps.
Les: Got it okay. Thank you very much.
Speaker Change: Thanks, Thanks, Paul.
Les: One moment for our next question.
Speaker Change: Our next question comes from the line of <unk> <unk> with Ladenburg. Your line is open. Please go ahead.
Speaker Change: Hi, good morning, everyone and thank you for taking questions.
Speaker Change: Congrats on the progress this quarter a question I have is regarding the preparedness commercial preparedness on infrastructure. So I think you mentioned the increase of reps from 50 to 283 and two contracts. Obviously, so I think Joe might have thank.
Speaker Change: <unk> hundred mainland.
Speaker Change: Potentially Eugene and one or two I think.
Speaker Change: Your guidance for building buildings.
Speaker Change: And the peak sales. So can you help us understand the sort of economies of scale, both increasing from 52% to 83, given that the actual 10 times more potential peak sales. So maybe you can.
Speaker Change: Help us understand this from commercial credits perspective sure absolutely David do you want to comment on that and why we feel like the 83 is an appropriate number even despite the fact that it's obviously a much.
Speaker Change: The bigger opportunity.
Speaker Change: Yes, that's a great question.
So our <unk>.
Speaker Change: Analysis to increase the size of our commercial footprint from about 52 territories to around 83 territories is really hinged on the patient epidemiology.
Speaker Change: And one important thing to note is that with Joe <unk> in the.
Speaker Change: Low grade <unk>.
Speaker Change: With something like 6000 patients in a year that might present, the likelihood of any one neurologist seeing more than one of these is fairly uncommon in the case of low grade intermediate risk <unk>, what we hear from customers is that they are seeing they know who these patients are in the vast majority of urology.
Speaker Change: Practices do you see these patients and so the sizing of 83 territories allows us to get to the vast majority of treating physicians and practices. So its something like 80, roughly 85% of the markets covered.
Speaker Change: So we are really hitting a sweet spot in learning from our experiences with Yamato net the frequency of our visits does make a difference. So we are we're increasing that and importantly, the patients are in these practices. So we feel very good about the size of our <unk>.
Speaker Change: Commercial footprint going forward and it will allow us to see and provide the comprehensive service that we know is required to help them get these patients started and through therapy.
Speaker Change: Yeah, and the only thing I'll add is that in addition to the 83 reps as David talked about we have nurse educators, we have medical science liaisons for peer to peer we have.
Speaker Change: Operations managers to help with the operational lift and logistics pieces of it and we've got account directors and field reimbursement managers. So it's not just the 83 at six other roles that we have found to be very critical.
Speaker Change: Comprehensive support system for physician offices, so again, given the entire field organization is much greater than 83, we feel really good about about the number and where we are.
Speaker Change: Thank you thanks, so much.
Speaker Change: Thank you. Thank you and I am showing no further questions at this time I would like to hand, the conference back to Liz Barrett for any further remarks.
Speaker Change: Great. Thanks to everybody just wanted to say, thank you and it's been a very busy year in 2024, we've already turned the page in 2025.
Speaker Change: Will be the most transformational year for our company. We're excited about the opportunity for <unk> in one or two to bring that to patients and then we look forward to providing more updates as some as things happen throughout the year. So I appreciate everyone. Joining you can disconnect now thank you.
Speaker Change: This concludes today's conference call. Thank you for participating and you may now disconnect everyone have a great day.
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Speaker Change: Good morning, ladies and gentlemen, and thank you for standing by welcome to the Euro Gen Pharma fourth quarter and full year 2024 earnings call. Please be advised that today's conference is being recorded I would now like to hand, the conference over to your Speaker today Center around head of Investor Relations. Please go ahead.
Speaker Change: Thank you operator, good morning, everyone and welcome to European Pharma fourth quarter, and full year 2024 financial results and business update conference call.
Earlier. This morning, we issued a press release, providing an overview of our recent corporate highlights and financial results for the fourth quarter and year ended December 31 2024.
Speaker Change: The press release can be accessed on the investors portion of our website at investors thought Youre adjourn dot com.
Liz Barrett: Joining me on the call today are Liz Barrett, President and Chief Executive Officer, Dr. Mark Schoenberg, Chief Medical Officer, David <unk>, Chief Commercial Officer, and Christopher <unk>, Chief Financial Officer.
Liz Barrett: During today's call, we will be making certain forward looking statements. These may include statements regarding our ongoing commercialization activities related to <unk>, our ongoing and planned clinical trials commercial and clinical milestones market and revenue opportunities, our commercialization strategy and expectations as well as potential future <unk>.
Liz Barrett: <unk> activities for <unk> in one or two if approved anticipated data regulatory filings and decisions <unk> being the primary growth driver for European approved future R&D efforts, our corporate goals in 2025 financial guidance among other things.
Liz Barrett: These forward looking statements are based on current information assumptions and expectations that are subject to change a description of potential risks can be found in our earnings press release and latest SEC disclosure documents.
Speaker Change: Cautioned not to place undue reliance on these forward looking statements and <unk> disclaims any obligation to update these statements I'll now turn the call over to Linzess.
Speaker Change: Thank you Vincent and thank you for joining US. This morning, 2024 with a year of progress for <unk> as we continue to advance our mission of pioneering new therapies that meet the unique needs of patients with euro failure and specialty cancers.
Speaker Change: We achieved a major milestone by submitting a new drug application for <unk> 102, our investigational product for intermediate risk low grade non muscle invasive bladder cancer ahead of schedule.
Speaker Change: With FDA review underway and a <unk> target date of June 13th we are well positioned to bring this innovative therapy to patients.
Speaker Change: At the same time, we continued to generate compelling clinical data that reinforces Eugene 100, two's safety efficacy and paradigm changing potential of <unk>.
Speaker Change: Commercial product <unk> continues to grow and we have made meaningful progress advancing our early stage pipeline.
Speaker Change: Additionally, we strengthened our leadership team, ensuring we have the expertise and vision to drive <unk> next phase of success.
Speaker Change: I will begin with an important clinical update on the pivotal envision phase III trial that serves as the foundation for the new GM wanted to NDA submission.
Speaker Change: Envision demonstrated a compelling complete response rate and unprecedented durability as a reminder, the CR rate at three months stood at an impressive 79, 6% and the 12 months' duration of response was an unprecedented 82, 3% by Kaplan Meier analysis.
Speaker Change: As the data continue to mature we are highly encouraged by the disease free status of many patients in follow up.
Today, we are reporting updated 18 months duration of response data from envision and note that these results remain consistent with our previous Kaplan Meier estimate.
Speaker Change: 101 patients now followed for at least 18 months. Following CR are 21 months post therapy start the update of duration of response is 86% by.
Speaker Change: By Kaplan Meier analysis.
Speaker Change: The median follow up time for these patients has now extended to $18 seven months. After three months CR up from $13 eight months at the previous data cut and the median duration of response is still not reached.
Speaker Change: We have provided these data to the FDA and our 120 day update and they will be part of the submission.
Speaker Change: The durability of response is critical for a disease with historically high recurrence rate by extending disease free periods using in one or two has the potential to increase disease and treatment free intervals, which are associated with morbidity and quality of life challenges in this population.
Speaker Change: We engaged with the FDA in a productive mid cycle review meeting this past week. The agency confirmed they will be referring the NDA to odette.
Speaker Change: Previously indicated the meeting will take place in May and we are awaiting official publication of the meeting date in the federal registry.
Speaker Change: We are aligned with the agency that the Advisory Committee presentations and materials were focused on the recurrent patient population.
Speaker Change: <unk> in the envision trial, therefore, we believe that Eugene and one or two if approved will be indicated in the recurrent patient population. It is important to highlight that our data in this population is highly supportive and this group represents the vast majority of the overall revenue opportunity.
Speaker Change: While these meetings are confidential and theres a limit to what we can share today I want to take this opportunity to reaffirm our confidence in the strength of the data package, we have submitted and in the potential of <unk> in one or two to address the significant unmet need for patients.
Speaker Change: We remain fully focused on preparing for <unk> and look forward to the opportunity to present, our compelling data to the advisory committee and engage with the broader medical community. If approved <unk> will become the first medicine for this patient population introducing a potentially paradigm shifting solution for.
Speaker Change: This disease.
Speaker Change: And a profile of Eugene one or two will be transformative for <unk> as it represents a significant market opportunity.
Speaker Change: Population nearly 10 times larger than the market for John might have.
Speaker Change: This translates to a total addressable market of more than $5 billion <unk>.
Speaker Change: Importantly, our ability to identify and target physicians and their patients for UGI and one or two will be easier.
Speaker Change: <unk> low grade upper tract, <unk> carcinoma, which is a dispersed rare disease low grade intermediate risk non muscle invasive bladder cancer, it's widespread and managed by nearly all urologists.
Speaker Change: UGI and wanted to is design for seamless integration into outpatient practice workflows.
Speaker Change: The ease of use creates the opportunity for physicians to expand their practices and enhance patient care.
Speaker Change: <unk> generated net product revenues of $94 million for the full year 2024, compared to $82 7 million for the prior year the increase of $7 $7 million year over year was primarily driven by increased underlying demand for job might have partially.
Speaker Change: All set by a decrease in creates AG sales and an increase in 340 <unk> charge backs, if we focus on actual underlying product demand.
Speaker Change: Sales grew by approximately 12% year over year at.
Speaker Change: Our commercial team recognized that this is a high touch product. So we have been focused on increasing our reach and frequency with key accounts.
Speaker Change: This has resulted in consistent improvement across several key metrics, including overall volume patient enrollment forms and new patient starts new script writers and new sites of care.
Speaker Change: In Q4 of 2024, we saw our highest ever number of demand units, David Lamb will provide more details in his update.
Speaker Change: We have also made great progress in advancing our long term growth strategy with the recent acquisition of ICB 10, 42 from iconic beer. This next generation investigational <unk> <unk> represents an exciting opportunity in cancer care with.
Speaker Change: With its unique mechanism ICB $10 42 is designed to selectively target and destroy tumor cells without compromising its lytic activity.
Speaker Change: It's designed to enter a broad spectrum of tumor cells, allowing it to potentially treat a wide range of tumor types.
Speaker Change: This acquisition aligns with our vision and strategic focus to develop innovative therapies to address critical gaps in cancer care.
Speaker Change: For those interested a replay of our investor webinar announcing the acquisition is available on our website.
Speaker Change: <unk> ended 2024 with a strong balance sheet holding $241 7 million in cash cash equivalents and marketable securities we remain well capitalized to execute our operating plan and advance the company to <unk> profitability with the anticipated <unk>.
Speaker Change: Launched a new GM, one or two later this year I will now turn the call over to Mark Schoenberg, Chief Medical Officer for a clinical update Mark.
Mark Schoenberg: Thank you Liz beginning with the NDA for <unk> 102, our clinical and regulatory teams are fully engaged in preparing for the <unk> meeting, where Eugene one or two will be reviewed as a potential paradigm shift in the treatment of low grade intermediate risk non muscle invasive bladder cancer.
Mark Schoenberg: We believe a key consideration for the FDA is that Eugene and one or two represents a fundamental change in how we approach this disease moving away from repetitive surgical procedures that have been the standard for decades, we feel confident heading into this discussion.
Mark Schoenberg: Just appreciate the need for alternative treatment options that could potentially provide longer treatment and recurrence free survival in Eugene and one or two has the potential to fill this gap offering office space administration that aligns with the way urologist practice.
Mark Schoenberg: Body of clinical evidence supporting new Gen, one or two continues to grow.
Mark Schoenberg: As highlighted the latest duration of response data from envision showing an impressive 88, 6% duration of response at 18 months for those patients who had achieved a complete response at three months.
Mark Schoenberg: We will continue to follow these patients, but the current data represent a potentially significant advance for patients as we have not reached the median duration of response, we continue to appropriately engage with the broader medical community to share our clinical findings from envision.
Mark Schoenberg: The envision trial results were recently published in the February print edition of the journal of Urology and were also presented at the society of Urologic oncology or <unk> annual meeting, which took place in Dallas in December.
Mark Schoenberg: It suo, we also had the opportunity to present long term follow up data from the Olympus trial, which demonstrated a median duration of response of approximately four years in patients who had achieved a complete response with gel midol. These.
Mark Schoenberg: These data further reinforced <unk> role as a primary treatment for low grade upper tract Youre appeal, youll cancer, providing patients with a meaningful alternative to surgery and <unk>.
Mark Schoenberg: January previously announced results from the real World Post commercialization study of <unk> were published in Urologic oncology. This long term study evaluated 56 patients from 15 high volume centers, we achieved complete responses with Joe Mundo, demonstrating a recurrence free survival rate of 68%.
Mark Schoenberg: At three years, notably recurrence free survival was consistent irrespective of tumor size location number of tumors and alluded in administration with no difference between primary chemo ablation and as adjuvant therapy post endoscopic ablation. These findings further support the use of Joe.
Mark Schoenberg: <unk> in a broad patient population.
Mark Schoenberg: Turning now to the pipeline, we have a comprehensive lifecycle management plan for <unk> and <unk> 102 enrollment continues in the phase III Utopia trial, which is evaluating <unk> 103, our next generation product for low grade intermediate risk <unk> Utopia as a single arm multicenter.
Mark Schoenberg: Study with a protocol similar to the envision trial.
Mark Schoenberg: Low grade intermediate risk disease patients with recurrent disease are receiving <unk> 103 via intra vesicle installation once a week for six weeks.
Mark Schoenberg: Efficacy will be assessed based on the complete response rate at the three month, Mark and patients will be followed to evaluate durability of response, we expect to complete enrollment this year and anticipate reporting topline data in 2026, we have a similar development plan for <unk> 104, our next generation formulation of <unk>.
Mark Schoenberg: And expect to commence a single arm phase III study in the first half of 2025 and.
Mark Schoenberg: In February we were pleased to announce the acquisition of ICD $10 42, a next generation oncologic virus developed by icon of you. This addition, meaningfully enhances <unk> pipeline by introducing a highly innovative approach to selectively targeting and destroy cancer cells, while simultaneously activating a robust.
Mark Schoenberg: Anti tumor immune response.
Mark Schoenberg: <unk> 42 was thoughtfully engineered to achieve efficient cell entry strong selectivity for malignant cells and rapid replication within the tumor microenvironment features that drive both direct tumor cell license and the induction of a durable tumor specific immune response, our development plan for $10 42 is advancing with <unk>.
Mark Schoenberg: IND, enabling studies expected to begin this year, we intend to evaluate several modes of administration, including delivery using our proprietary <unk> technology.
Mark Schoenberg: While our initial focus will be on bladder cancer, we anticipate exploring $10 40 twos potential to address a broader range of malignancies beyond the genital urinary space finally, Eurasia and will have a significant presence at this year's American Urology Association meeting to take place April 26 to 29 in Las Vegas, Nevada.
Mark Schoenberg: This is an important conference for us and I'm pleased to say that we have six abstracts accepted. This year. These include a podium presentation of the envision trial results by Dr. Sandeep facade. The principal investigator of the <unk> 102 trial now.
David Lim: Now over to David Lim for a commercial update.
David Lim: Thank you Mark.
Morning, everyone.
David Lim: I am pleased to provide an update on our commercial initiatives as we move closer to the <unk> target action date for UGI and 102.
David Lim: The upcoming launch with market pivotal moment in <unk> evolution from a rare disease focused company to a multi product specialty driven team.
David Lim: Our goal is to deliver a seamless and successful launch ensuring that our efforts translate into patient access to this potentially groundbreaking therapeutic option.
David Lim: Our immediate priority is continuing to execute our comprehensive pre commercial strategy that we believe will lay a strong foundation for widespread access and adoption of <unk> 102.
David Lim: We are confident in the strength of our clinical data and the potential it holds for patients with low grade intermediate risk non muscle invasive bladder cancer.
David Lim: We are focused on three key priorities and our preapproval preparation.
David Lim: First we are actively working to raise awareness about the unmet needs in low grade intermediate risk non muscle invasive bladder cancer through a variety of educational programs.
David Lim: Our medical affairs team is engaging in scientific exchange activities involving the clinical data supporting <unk> and 102.
David Lim: Next we continue to gather insights across key stakeholders, such as prescribers payers and patients in order to refine our launch plans of course, we'll leverage learnings we have gained through our experience with <unk>.
David Lim: And finally, we are scaling our commercial infrastructure and capabilities to ensure we're appropriately sized to fully address the opportunity for UGI on one or two if approved.
David Lim: We are significantly expanding our sales force from 52 reps today to approximately 83 at our anticipated launch.
David Lim: We are also building out our customer support capabilities to support a broader portfolio, particularly in our ability to provide comprehensive training and support for health care professionals and their staff.
David Lim: To ensure a seamless integration of <unk> into treatment protocols.
David Lim: Additionally, we are preparing our engagement initiatives to inform both clinical practices and patients about <unk> 100, twos coverage options and reimbursement.
David Lim: While <unk> 102 will initially be assigned a miscellaneous J code for billing.
David Lim: We expect to secure a permanent J code by January 2026, which will be particularly important in the community setting.
David Lim: In the interim we are fully committed to offering strong reimbursement support to help providers navigate the coating process, helping to ensure the integration of <unk> and 102 is as smooth as possible.
David Lim: We are on the cusp of a truly exciting launch and we are energized by the opportunity to bring this investigational treatment to patients and continue making strides in the fight against bladder cancer.
Liz Barrett: Turning to Jim Idaho, as Liz mentioned, the product delivered $87 $4 million in underlying demand revenue in 2024.
Liz Barrett: An increase of 12% versus the prior year.
Liz Barrett: Fourth quarter underlying demand revenues increased 15% year over year, and we saw consistent improvement across multiple key metrics.
Liz Barrett: Demand units in Q4 were our highest ever up 15% compared to Q4 of last year.
New prescribers and new patient starts increased 33% and 13% respectively in 2024 compared to 2023.
Mark Schoenberg: The recent clinical data and publications that mark referenced including the long term follow up from Olympus and positive results from the real World study further underscore the impressive durability of <unk>.
Mark Schoenberg: These results continue to reinforce its important role in treating low grade upper tract Europe yoyo cancer.
Mark Schoenberg: We are continuing our high tech strategy with a focused effort on key accounts, ensuring Jo Mira remains a key part of our commercial portfolio.
Mark Schoenberg: As we expand our sales force in preparation for the <unk> in 100 to launch the New Representatives will also be promoting Jim Idaho.
Mark Schoenberg: This strategic increase in our sales team is designed to drive growth for both products enhancing our ability to support key accounts and maximize market impact.
Chris Degner: I'll now turn the call over to Chris <unk> to discuss our financials.
Speaker Change: Thank you David before I turn to our financial results I am pleased to report <unk> enter 2025 from a position of financial strength.
Speaker Change: At the close of 2024 cash cash equivalents and marketable securities totaled $241 7 million.
Speaker Change: Providing a solid foundation to continue executing on our strategic initiatives with.
With the anticipated launch of Eugene on one or two later this year, we are well equipped to drive our company towards profitability and create long term value for our shareholders.
Speaker Change: Turning now to our financial results.
Speaker Change: <unk> net product revenues were $24 6 million in the fourth quarter of 2024 compared to $23 5 million for the same period in 2023.
Speaker Change: Underlying demand revenue increased by 15%, partially offset by a decrease in creates act sales, which totaled <unk> $2 million in the fourth quarter of 2024 compared to $2 4 million for the same period in 2023.
Joe Mundo: Joe <unk> net product revenues for the full year ended December 31, 2024 were $94 million compared with $82 $7 million of revenue in 2023.
Joe Mundo: Research and development expenses for the fourth quarter of 2024 were $14 $9 million as compared to $11 3 million for the same period in 2023.
Joe Mundo: <unk> expenses for the full year of 2024 were $57 $1 million compared with $45 $6 million for 2023.
Joe Mundo: The year over year increase was primarily driven by manufacturing expenses for our product candidates regulatory expenses related to you Jan one or two and costs associated with the Eugene 103 Utopia trial.
Joe Mundo: SG&A expenses for the fourth quarter of 2024 were $34 9 million.
Joe Mundo: Compared to $24 6 million in the same period in 2023.
Joe Mundo: For the full year 2020 for SG&A expenses were $121 $2 million compared with $93 $3 million in 2023.
Joe Mundo: The year over year increase was primarily driven by Eugene one or two commercial preparation activities.
Joe Mundo: We reported non cash financing expense related to the prepaid forward obligation to RTW investments of $6 $1 million in the fourth quarter of 2024 compared to $5 $5 million in the same period in 2023.
Joe Mundo: Non cash financing expense related to RTW investments was $23 $4 million in the full year 2024, compared with $21 $6 million in 2023.
Joe Mundo: Interest expense related to the outstanding $125 million term loan facility with Pharmacon advisors was $3 9 million and $12 $5 million, respectively for the fourth quarter and full year 2024, compared with $3 6 million and $14 7 million respective.
Joe Mundo: <unk> for the fourth quarter and full year 2023.
Joe Mundo: Net loss was 37 $5 million or <unk> 80 per basic and diluted share in the fourth quarter of 2024, compared with a net loss of $26 million or <unk> 72 per basic and diluted share in the same period in 2023.
Joe Mundo: For the full year 2024, net loss was $126 9 million or $2 96 per basic and diluted share compared with a net loss of $102 2 million or $3 55 per basic and diluted share in 2023.
Joe Mundo: Turning to forward guidance for 2025.
Joe Mundo: The company expects full year 2025, Jo Mira revenues to be in the range of $94 million to $98 million.
Joe Mundo: This implies a year over year growth rate of approximately 8% to 12% over the $87 $4 million and demand driven Jo Mira revenues in 2024, which excludes the $3 million and creates act sales reported in 2024.
Joe Mundo: Full year 2025 operating expenses are expected to be in the range of $215 million to $225 million <unk>.
Joe Mundo: Including noncash share based compensation expense of 11% to $14 million.
Joe Mundo: The anticipated increase in full year operating expenses is primarily driven by the planned sales force expansion and additional commercial and medical activities to support the Eugene I wanted to launch as well as the investment of our Eugene one of three new Gen 104 clinical programs.
Joe Mundo: We are now ready to open the call for questions.
Joe Mundo: Operator.
Speaker Change: Thank you to ask a question at this time. Please press star one on your telephone and wait for your name to be announced to withdraw. Your question. Please press star one again, one moment for our first question.
Tara Bancroft: And our first question is going to come from the line of Tara Bancroft with TD Cowen. Your line is open. Please go ahead.
Nick: Great. Thanks, This is Nick on for Tayo.
Nick: You noted on the call that you anticipate approval in the recurrent setting do you anticipate that you Jan one or two you could still be used in about 10% of patients or so that are in eligible for surgery, which would be at the frontline setting and with this then required to be used off label. Thanks.
Speaker Change: Hi, Nick.
Liz Barrett: It's Liz.
Speaker Change: I think that would be considered off label. So clearly we wouldn't be able to promote there and I think it would be up to the physician to work with their insurance company because thats really what it comes down to is really more of a.
Speaker Change: A situation of making sure that they can get paid for it so as we've talked about before we thought we actually thought they might go there. They did in the meeting and it was really driven by the fact that they always viewed that as being the unmet need.
Speaker Change: And it doesn't change our revenue projections that would be really clear about that so we still believe.
Speaker Change: That the medicine.
Speaker Change: 102 will be over $1 billion revenue.
Speaker Change: <unk>.
Speaker Change: And that doesn't change that and never data is more about exactly what you're talking about like we want physicians to have the ability for those few patients that they really don't want to put under because we all know that the newly diagnosed patients they're almost all of them get it <unk> for diagnostic purposes, but there are a handful of patients that pause.
Speaker Change: Patients would just prefer not to put under Mark can comment I think about what would happen. They usually do it anyway, right and it's a little bit more risky, but and physicians have told us they would like they would like to be able to make that choice and not and not the FDA, but.
Speaker Change: It was clear in the conversation that we had with them.
Speaker Change: We had discussed it internally and knew that if they did go there it's better for US frankly to go into the <unk> aligned with them on that so that we don't spend time in the <unk>.
Speaker Change: Going back and forth on that and that we also don't risk.
Speaker Change: Vote, because negative vote because.
Speaker Change: Panelists say, well I don't want that newly diagnosed.
Speaker Change: This obviously makes it a <unk>.
Speaker Change: While our patient population, but not really smaller from a pump.
Speaker Change: Our business opportunity, but to your point it would be up to the position to work with the payer and the patient for them to get reimbursed and we're obviously also.
Speaker Change: Think about whether we should do some some clinical work in this space or not but it's a very small financial opportunity again, just a matter of being able to help physicians make it easier for them to use.
Speaker Change: That's very clear thank you very much.
Speaker Change: <unk>.
Speaker Change: One moment for our next question.
Michael Schmidt: Our next question will be coming from the line of Michael Schmidt with Guggenheim. Your line is open. Please go ahead.
Michael Schmidt: Hey, good morning, Thanks for taking our questions.
Michael Schmidt: On new Gen, one or two as you think about the potential FDA approval later this summer in June.
Michael Schmidt: How should investors think about the initial launch trajectory.
Michael Schmidt: Perhaps relative to <unk> or other potential benchmarks.
Michael Schmidt: Are there any any analogs that you should look at.
Michael Schmidt: And then how should we think about pricing again of one or two relative to Joe Mito and would you expect any meaningful channel inventory built earlier this year.
Michael Schmidt: Alright, Thanks for the question I'll turn it over to David <unk>, Our Chief commercial officer to answer those questions David.
David: Yes. Thanks for the question in terms of launch trajectory.
Michael Schmidt: We intend to.
Michael Schmidt: Mentioned, we're going to continue educating our physician provider universe.
Michael Schmidt: Obviously, maintaining a lot of support so the way we're thinking about the overall shape of the curve is very akin to how we thought about Joe Idaho Wild.
Michael Schmidt: While the numbers the absolute numbers would be larger because of the patient patient population.
Michael Schmidt: Overall shape.
Michael Schmidt: Modeling very similar to that of Joe Michael because theres a lot of similarities in terms of the operational considerations.
Michael Schmidt: On your question with regard to pricing I think we've been we continue to think of pricing in the 18 to $19000 per dose.
Michael Schmidt: However, we continue to do research with payers to refine our assumptions.
Michael Schmidt: That's how we're thinking about it for right now.
Michael Schmidt: Great. Thank you. Thank you.
Michael Schmidt: Thank you one moment as we move on to the next question.
Speaker Change: Our next question comes from the line of Gregory.
Gregory Silver: Silver <unk> with C. H H C. Wainwright. Your line is open. Please go ahead.
Gregory Silver: Thanks, so much for taking our questions firstly with respect to your Jan one or two and the projected reimbursement environment. I was just wondering if you could maybe provide us with additional gloriane hilarity regarding the difference in reimbursement level and degree of market access that you expect to have during the period immediately after the <unk>.
Gregory Silver: Launch when you will have the generic J code and once you actually have a specific J code in January of 2020, just kind of spell out for us how the environment is going to change when you shift from one J code to another and then secondly, with regard to the pipeline development activities can you give us some update on how enrollment kinetics.
Gregory Silver: So appear to be progressing in the <unk> 103 program and if you still expect to be in a position.
Gregory Silver: To report data from that trial, either next year or in 2027. Thank you.
Speaker Change: Yes, great question, So I'll ask David to answer the first question around reimbursement and then move to Mark to give you an update on <unk> three and timing so David.
Speaker Change: Yes. Thanks again for the question there from a reimbursement perspective as we stated in the initial six months assuming the June 13th.
Speaker Change: We do anticipate a miscellaneous J code being used essentially what this means from an assumption standpoint is that the overall reimbursement process. We believe takes a little bit longer so somewhere around the 50 days to 60 days for a provider to be.
Speaker Change: Reimbursed and that number does cut down by about half when we have a unique permanent miscellaneous J code, which we assume will be in the January 2026 timeframe. So our real focus is going to be making sure that we are with our accounts supporting them in the coding and reimbursement process to guide them through that initial pick.
Speaker Change: <unk>.
Speaker Change: And so we will continue to provide the same level of support as we are now just to a broader audience.
Speaker Change: Well, let me I just wanted to add a couple of things.
Speaker Change: We will have services.
Speaker Change: To get physicians through that time period. So like we did with <unk>, we will have a longer dating so they don't have to put the money out before they get reimbursed as well as the hub and the other thing that I'll comment on is we also expect like we saw with the initial uptake from our site of care perspective will be.
Speaker Change: More in the hospital and the institutions.
Speaker Change: The pharmacy takes the risk at that point in time and not.
Speaker Change: The private practice so.
Speaker Change: The J code.
Speaker Change: More challenging as really the private practices, who are concerned about putting out that kind of money in taking the risk of not being reimbursed. So we expect those physicians would just take their patient to the hospital or the institution in which they are affiliated in they would they would conduct the.
Speaker Change: The therapy at that place so again as we.
Speaker Change: We mentioned earlier as David mentioned earlier I think you can look at John Mito in the initial couple of first 18 months I would not look at Yamato post those 18 months, because we do believe that that.
Speaker Change: The opportunity is far greater for <unk>, two and we should see an acceleration that's greater than that.
Speaker Change: Then we see with <unk>, but the first couple of years of John <unk> and our first year, we sold 15 mill Brown the same six months.
Speaker Change: Almost $15 million in revenue and then it went up to almost $50 million in the second full year following so.
Speaker Change: Could you use that as a good analog for the first 18 months, so hopefully that helps.
Speaker Change: Well, what I would also mention of course is for those who remember you launched Jo Mira in the middle of a pandemic cannot be paid for with one or two.
Speaker Change: Xactly, absolutely, but if you just take into consideration and I'm not suggesting the same amount of revenue but.
Speaker Change: David's point earlier, it's a much bigger patient population the price may be a little bit left but but you can you can see at 10 times the size, even if Joe might award.
Analog or will it still be a very positive for the first few months.
Speaker Change: <unk> of the launch, but Youre, absolutely right, we launched into a pandemic and hopefully knock on wood, everybody, we won't be having a pandemic in 'twenty.
Mark Schoenberg: 2025, and 2026, so thanks for the question and the comment as well and then I'll turn it over to Mark to answer the question I wanted to remark.
Mark Schoenberg: Thanks Louis.
Speaker Change: With respect to one of three and the trial is the Utopia trial.
Speaker Change: We're anticipating complete enrollment this year data in 2006 that approval in 2007, so it's sort of a lock step progression, but things are going well and we're very optimistic that we're going be able to keep it at that timeline.
Speaker Change: Thank you very much.
Speaker Change: Thank you and one moment as we move on to the next question.
Speaker Change: And our next question is going to come from the line of Lee Linker Shaw with Oppenheimer. Your line is open. Please go ahead.
Speaker Change: Good morning, and thanks for the update and taking our questions just to.
Speaker Change: One from us.
Speaker Change: Just just taking off the earlier question about examining.
Speaker Change: <unk> been naive patients with low grade.
Speaker Change: Just wondering if you could given the ongoing trial with 103, if you would look to possibly amend that or if you would look to do further study.
Speaker Change: In treatment naive for the benefit of three eventual label. Thank you.
Leland: Yes, it's a great question Leland and to be honest with you. This has happened last week. So we havent spent a lot of time thinking about it I think at the end of the day.
Leland: It would more likely be around generating data and real world use maybe like a registry or through an IR.
Leland: But because as I mentioned the opportunity it's fairly small although the good news with <unk> III is that we would be moving to.
Leland: Our patent protection on that that medicine will be until through 2041. So we have a lot of time. So I think we would take a look at it but no we would not amend the current 103 and the reason we would not amend the 103 is because we need to keep that study is close.
Leland: <unk> as possible so that because that's what they will be using as a comparison right. So to get that drug approved and approved quickly that we use in <unk> and <unk>. So you want to keep that study as quickly as possible, but we will evaluate Eugene one of three just like we've been talking about.
Leland: Three into high grade disease, we will look at other areas, where we can study <unk> three there may be other populations and it may be not just in the newly diagnosed intermediate risk, but there may be a population the unwilling and unable population, which is actually broader than just the intermediate risk and that's something that I've been.
Leland: Wanting to do for the last few years. So maybe we take an opportunity to do that and that would include newly diagnosed across a broader spectrum of patients.
Leland: Yes, physicians just don't want to our patients don't want to go to surgery, but it's a great question will have to give it some more thought from that perspective.
Speaker Change: Thanks Scott.
Leland: Slip in a quick second just in terms of the pipeline.
Speaker Change: Following the recent update on ICD would be 100 to 104, two and other collaborative agreement I'm. Just wondering if you have any plans to share more.
Speaker Change: They're either data or for more and more about the collaborations in 2025 and also 301, you might see more reveal from that ongoing development. Thank you yeah. Great question on the collaborations I think we will wait till we see some data some feasibility data. These early studies there.
Speaker Change: Really the first question is can you put the drug in the gel does it work does it does it provide the benefit and we think it does so we will do some some preclinical work there, but absolutely if that moves forward, we will share that and then Mark do you just want to give an update on what we expect that we'll see this year for <unk> 301, and $2 42.
Mark Schoenberg: Yes, thanks, so with respect to <unk> 42, this year as IND, enabling studies. So we will be focused on that formulation et cetera.
Speaker Change: Obviously, we have notable output.
Speaker Change: Output from that we would share that was points out it will probably be next year before we have substance of data this year and it's early in that program with respect to 301, we did announce the monotherapy data yes, you over this past year, we actually as everyone knows have combination arms in that trial, which is a phase one trial combining.
Speaker Change: 301, with our <unk> agonist, <unk> 201, as well as with Gemcitabine, we have seen some interesting data with respect to responses again, it's a phase one trial, but we are following those patients for the durability of those responses and anticipate reporting that later this year.
Speaker Change: Super Thanks very much.
Speaker Change: Thank you and one moment as we move on to the next question.
Speaker Change: Our next question is going to come from the line of Paul Choi with Goldman Sachs. Your line is open. Please go ahead.
Paul Choi: Hi, Thank you good morning, and thanks for taking our questions.
Paul Choi: Wanted to revisit pricing for one or two for a moment and just wanted to ask given the.
Paul Choi: Price of durability that envision data has shown relative to the total all in cost for repeat terabytes.
Paul Choi: Have you sort of stress test, maybe potentially higher pricing just sort of your thoughts payer reactions on this four for one or two here just again, given the durability and potential longer term rate reduction in cost any color there would be great.
And second.
Paul Choi: With one to three potentially launching as early as 2027 can you comment on how youre thinking about.
Paul Choi: <unk> 102 versus 103 would there be a switch strategy or would you just sort of.
Paul Choi: Sort of fade out one or two in favor 100, III given the longer IP considerations, there and just how youre thinking about the potential.
Paul Choi: Potential return on one or two if you do think about a switch strategy. Thank you very much.
Speaker Change: Yes, great questions, Paul and I can tell you that we are revisiting we had already.
Speaker Change: Research underway because their pricing research we had done was before the impressive.
Speaker Change: Data to you or to your point durability data. So we are looking at that and we do believe that there is an opportunity.
Speaker Change: To increase that slightly so we will definitely be looking at that and I'm sorry. Your second question remind me again.
Les: Yes sure Les.
Les: How youre thinking about positioning 103 versus one two apart from IP and just are you going to fade out one or two out.
Les: Just how do you think about the potential return profile for one or two if you do switch to one out of three yes, no absolutely sorry, but yes, what we would do is we would as soon as one of the three is approved we would likely wait for the J code right ticket. So theres no concern about reimbursement, but then after that we would actually fade out Eugene.
Les: I know too and we would take your GM, one or two off the market and shift all of that.
Les: The <unk>.
Les: The business to AGM, one of three and that would that provides US is there is that one or two won't be on the market. So there won't be any automatic substitution or there won't be an interchange ability. So if generic or someone came in at post 2031.
Les: Would actually have to promote the product and the doctor would actually have to write for their specific product. So it wouldn't be a one or two for them to write.
Again it be interchangeable in addition to that I don't know if anyone saw but we had the product specific guidance came out in November around Yamato and.
Les: The guidance says that they have to demonstrate that it is identical not equivalent but identical and I think that raises the bar for anyone to come in regardless of whether one or two is on the market or not and we're obviously just shifting the information that we have <unk> because <unk> is the only one.
Les: Now that the generics have obviously since <unk> been on the market, but again as you would not be.
Les: But it would not be on the market for the generic companies to be able to compare to.
Les: So I hope that helps.
Les: Got it okay. Thank you very much.
Paul Choi: Thanks, Thanks, Paul.
Speaker Change: One moment for our next question.
Speaker Change: Our next question comes from the line of Adam <unk> with Ladenburg. Your line is open. Please go ahead.
Speaker Change: Hi, Good morning, everyone and thank you for taking questions and congrats on the progress. This quarter. A question I have is regarding the preparedness commercial preparedness on infrastructure. So I think you mentioned the increase of reps from 50 to 283 and your contracts, obviously select <unk>.
Speaker Change: <unk> Zealand.
Speaker Change: And.
Speaker Change: Potentially Eugene and one or two I think your guidance for building feeling in.
Speaker Change: And the peak sales. So can you help us understand the sort of economies of scale of increasing from 52% to Asia III given that this actual 10 times more potential peak sales. So maybe you can.
Speaker Change: Help us understand this from commercial credits perspective sure absolutely David do you want to comment on that and why we feel like the 83 is is an appropriate number even despite the fact that it's a it's obviously a much.
Speaker Change: Bigger opportunity.
David: Yes, that's a great question so our.
David: Analysis to increase the size of our commercial footprint from about 52 territories to around 83 territories is really hinged on the patient epidemiology.
Speaker Change: And one important thing to note is that with Joe <unk> in the low.
David: Low grade <unk>.
David: With something like 6000 patients in a year that might present, the likelihood of any one neurologist seeing more than one of these is fairly uncommon in the case of low grade intermediate risk <unk>, what we hear from customers is that they are seeing they know who these patients are and the vast majority of urology.
David: Practices do you see these patients and so the the sizing of 83 territories allows us to get to the vast majority of treating physicians and practices. So something like 80, roughly 85% of the markets covered.
David: So we are really hitting a sweet spot in learning from our experiences with Zohydro net the frequency of our visits does make a difference. So we are we're increasing that and importantly, the patients are in these practices. So we feel very good about the size of our <unk>.
David: Commercial footprint going forward and it will allow us to see and provide the comprehensive service that we know is required to help them get these patients started and through therapy.
David: Yeah, and the only thing I'll add is that in addition to the 83 reps as David talked about we have nurse educators, we have medical science liaisons for peer to peer we have.
David: Operations managers to help with the operational lift and logistics pieces of it and we've got account directors and field reimbursement managers. So it's not just the 83 as these other roles that we have found to be very critical.
David: They're really comprehensive support system for physician offices, so giving given the entire field organization is much greater than 83, we feel really good about about the number and where we are.
David: Thank you thanks, so much.
Speaker Change: Thank you. Thank you and I am showing no further questions at this time I would like to hand, the conference back to Liz Barrett for any further remarks.
Speaker Change: Great. Thanks to everybody just wanted to say, thank you and it's been a very busy year in 2024, we've already turned the page in 2025.
Speaker Change: Will be the most transformational year for our company. We're excited about the opportunity for <unk> in one or two to bring that to patients and then we look forward to providing more more updated.
Speaker Change: Things happen throughout the year. So I appreciate everyone. Joining you can disconnect now thank you.
Speaker Change: This concludes today's conference call. Thank you for participating and you may now disconnect everyone have a great day.