UroGen Pharma Ltd.

Good morning, ladies and gentlemen, and thank you for standing by. Welcome to the Eurogen Farmer 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, Vincent Perrone, head of investor relations. Please go ahead.

Thank you, operator. Good morning, everyone. and welcome to Eurogen Pharma's 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 31st, 2024. The press release can be accessed on the investors portion of our website at investors.eurogen.com. Joining me on the call today are Liz Barrett, President and Chief Executive Officer Dr. Mark Schoenberg, Chief Medical Officer, David Lin, Chief Commercial Officer, and Chris Degnan, Chief Financial Officer. During today's call, we will be making certain forward-looking statements. These may include statements regarding our ongoing commercialization activities related to Gelmyo, our ongoing and planned clinical trials, commercial and clinical milestones, market and revenue opportunities, our commercialization strategy and expectations, as well as potential future commercialization activities for UGN 102, if approved. Anticipated data, regulatory filings and decisions, UGN 102 being the primary growth driver for Eurogen, if approved, future R&D efforts, our corporate goals, and 2025 financial guidance, among other things. 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. You are cautioned not to place undue reliance on these forward-looking statements, and your agent disclaims any obligation to update these statements. I'll now turn the call over to Liz.

Thank you, Vincent, and thank you for joining us this morning. 2024 was a year of progress for URGEN as we continue to advance our mission of pioneering new therapies that meet the unique needs of patients with urothelial and specialty cancers. We achieved a major milestone by submitting a new drug application for UGM-102, our investigational product for intermediate risk, low-grade, non-muscle invasive bladder cancer, ahead of schedule. With FDA review underway in a PDUFA target date of June 13th, we are well-positioned to bring this innovative therapy to patients. At the same time, we continue to generate compelling clinical data that reinforces UGN 102's safety, efficacy, and paradigm-changing potential. Our commercial product, Gelmito, continues to grow, and we have made meaningful progress advancing our early-stage pipeline. Additionally, We strengthened our leadership team, ensuring we have the expertise Envision to drive URGEN's next phase of success. I will begin with an important clinical update on the pivotal Envision phase three trial that serves as a foundation for the UGM-102 NDA submission. 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-month duration of response was an unprecedented 82.3% by Kappenmeier analysis. 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-month duration of response data from Envision, and note that these results remain consistent with our previous Kaplan-Meier estimates. With 101 patients now followed for at least 18 months following CR, or 21 months post-therapy start, the updated duration of response is 80.6% by Kaplan-Meier analysis. The median follow-up time for these patients has now extended to 18.7 months after three months CR, up from 13.8 months at the previous data cut, and the median duration of response is still not reached. We have provided these data to the FDA in 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 rates. By extending disease-free periods, UGM-102 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 ODAC. They previously indicated the meeting will take place in May, and we are awaiting official publication of the meeting date in the Federal Registry. We aligned with the agency that the advisory committee presentation and materials were focused on the recurrent patient population studied in the Envision trial. Therefore, we believe that UGM-102, if approved, will be indicated in the recurrent patient population. It's important to highlight that our data in this population is highly supportive, and this group represents the vast majority of the overall revenue opportunity. While these meetings are confidential and there's 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 UGM-102 to address the significant unmet need for patients. We remain fully focused on preparing for our ODAC and look forward to the opportunity to present our compelling data to the advisory committee and engage with the broader medical community. if approved, UGM-102 will become the first medicine for this patient population, introducing a potentially paradigm-shifting solution for this disease. An approval of UGM-102 will be transformative for urogen, as it represents a significant market opportunity, a population nearly 10 times larger than the market for gel mito. This translates to a total addressable market of more than $5 billion. Importantly, our ability to identify and target physicians and their patients for UGM-102 will be easier. Unlike low-grade upper tracheothelial carcinoma, which is a dispersed rare disease, low-grade intermediate-risk non-multi-invasive bladder cancer is widespread and managed by nearly all urologists. UGM-102 is designed for seamless integration into outpatient practice workflows. The ease of use creates the opportunity for physicians to expand their practices and enhance patient care. Gelmito generated net product revenues of $90.4 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 Gelmito. partially offset by a decrease in creates X cells and an increase in 340B chargebacks. If we focus on actual underlying product demand, sales grew by approximately 12% year over year. Our commercial team recognizes 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 2024, we saw our highest ever number of demand units. David Lim 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 ICBB 1042 from Econobier. This next-generation investigational oncolytic virus represents an exciting opportunity in cancer care. With its unique mechanism, ICVB 1042 is designed to selectively target and destroy tumor cells without compromising its lytic activity. 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. URGEN 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 the anticipated launch of UGM-102 later this year. I will now turn the call over to Mark Schomburg, our Chief Medical Officer, for a clinical update. Mark?

Thank you, Liz. Beginning with the NDA for UGM-102, our clinical and regulatory teams are fully engaged in preparing for the ODAC meeting, where UGM-102 will be reviewed as a potential paradigm shift in the treatment of low-grade intermediate-risk non-muscle invasive bladder cancer. We believe a key consideration for the FDA is that UGM-102 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. Neurologists appreciate the need for alternative treatment options that could potentially provide a longer treatment and recurrence-free survival. And UGN 102 has the potential to fill this gap, offering office-based administration that aligns with the way urologists practice. The body of clinical evidence supporting UGN 102 continues to grow. Liz highlighted the latest duration of response data from Envision, showing an impressive 80.6% duration of response at 18 months for those patients who had achieved a complete response at three months. We will continue to follow these patients, but the current data represent a potentially significant advance for patients as we have not reached a median duration of response. We continue to appropriately engage with the broader medical community to share our clinical findings from Envision. 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 SUO, annual meeting, which took place in Dallas in December. At 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 mito. These data further reinforced gel mito's role as a primary treatment for low-grade upper tract urothelial cancer, providing patients with a meaningful alternative to surgery. In January, previously announced results from the real-world post-commercialization study of gel mito were published in Urologic Oncology. This long-term study evaluated 56 patients from 15 high-volume centers who achieved complete responses with gel mito, demonstrating a recurrence-free survival rate of 68% at three years. Notably, recurrence-free survival was consistent irrespective of tumor size, location, number of tumors, and route of administration, with no difference between primary chemoablation and as adjuvant therapy post-endoscopic ablation. These findings further support the use of gel mito in a broad patient population. Turning now to the pipeline, we have a comprehensive life cycle management plan for gel mito and UGN-102. Enrollment continues in the phase three utopia trial, which is evaluating UGN-103 our next-generation product for low-grade intermediate-risk NMIBC. DUTOPIA is a single-arm, multi-center study with a protocol similar to the ENVISION trial. Low-grade intermediate-risk disease patients with recurrent disease are receiving UGN-103 via intravesical 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. We expect to complete enrollment this year and anticipate reporting top line data in 2026. We have a similar development plan for Eugene 104, our next generation formulation of gel mito, and expect to commence a single arm phase three study in the first half of 2025. In February, we were pleased to announce the acquisition of ICVB 1042, a next-generation oncolytic virus developed by Iconovir. This addition meaningfully enhances Urigin's pipeline by introducing a highly innovative approach to selectively targeting and destroying cancer cells while simultaneously activating a robust anti-tumor immune response. 1042 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 for 1042 is advancing, with IND-enabling studies expected to begin this year. We intend to evaluate several modes of administration, including delivery using our proprietary RT-gel technology. While our initial focus will be on bladder cancer, we anticipate exploring 1042's potential to address a broader range of malignancies beyond the genitourinary space. Finally, UroGen will have a significant presence at this year's American Urology Association meeting to take place April 26 to 29 in Las Vegas, Nevada. 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 Prasad, the principal investigator of the UGN-102 trial. Now over to Dave and Lynn for a commercial update.

Thank you, Mark. Good morning, everyone. I'm pleased to provide an update on our commercial initiatives as we move closer to the PDUFA target action date for UGN 102. The upcoming launch would mark a pivotal moment in Urigin's evolution from a rare disease-focused company to a multi-product specialty-driven team. Our goal is to deliver a seamless and successful launch ensuring that our efforts translate into patient access to this potentially groundbreaking therapeutic option. 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 UGN-102. 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. we're focused on three key priorities in our pre-approval preparation. First, we're 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. Our medical affairs team is engaging in scientific exchange activities involving the clinical data supporting UGN 102. 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 Joe Mito. And finally, we are scaling our commercial infrastructure and capabilities to ensure we're appropriately sized to fully address the opportunity for UGN 102, if approved. We are significantly expanding our sales force from 52 reps today to approximately 83 at our anticipated launch. 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 healthcare professionals and their staff to ensure seamless integration of UGN-102 into treatment protocols. Additionally, we are preparing our engagement initiatives to inform both clinical practices and patients about UGN-102's coverage options and reimbursement. While UGN 102 will initially be assigned a miscellaneous J code for billing, we expect to secure a permanent J code by January 2026, which will be particularly important in the community setting. In the interim, we are fully committed to offering strong reimbursement support to help providers navigate the coding process, helping to ensure the integration of UGN 102 is as smooth as possible. 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. Turning to Gelmito, as Liz mentioned, the product delivered $87.4 million in underlying demand revenue in 2024, an increase of 12% versus the prior year. Fourth quarter underlying demand revenues increased 15% year over year, and we saw consistent improvement across multiple key metrics. 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. 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 gel mito. These results continue to reinforce its important role in treating low-grade upper-track urothelial cancer. We are continuing our high-tech strategy with a focused effort on key accounts, ensuring gel mito remains a key part of our commercial portfolio. As we expand our sales force in preparation for the UGN-102 launch, The new representatives will also be promoting Gemido. 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. I will now turn the call over to Chris Degnan to discuss our financials.

Thank you, David. Before I turn to our financial results, I'm pleased to report Eurogen entered 2025 from a position of financial strength. At the close of 2024, cash, cash equivalents, and marketable securities totaled $241.7 million, providing a solid foundation to continue executing on our strategic initiatives. With the anticipated launch of UGN 102 later this year, we are well-equipped to drive our company towards profitability and create long-term value for our shareholders. Turning now to our financial results, Gelmito net product revenues were $24.6 million in the fourth quarter of 2024, compared to $23.5 million for the same period in 2023. Underlying demand revenue increased by 15%, partially offset by decrease in Creates Act sales, which totaled $0.2 million in the fourth quarter of 2024, compared to $2.4 million for the same period in 2023. Net product revenues for the full year ended December 31, 2024 were $90.4 million compared with $82.7 million of revenue in 2023. 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. R&D expenses for the full year of 2024 were $57.1 million compared with $45.6 million for 2023. The year-over-year increase was primarily driven by manufacturing expenses for our product candidates, regulatory expenses related to UGN-102, and costs associated with the UGN-103 utopia trial. SG&A expenses for the fourth quarter of 2024 were $34.9 million compared to $24.6 million in the same period in 2023. For the full year 2024, SG&A expenses were $121.2 million compared with $93.3 million in 2023. The year-over-year increase was primarily driven by UGN 102 commercial preparation activities. 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. Non-cash financing expense related to RTW investments was $23.4 million in the full year 2024 compared with $21.6 million in 2023. 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 for the fourth quarter and full year 2023. Net loss was $37.5 million or 80 cents per basic and diluted share in the fourth quarter of 2024 compared with a net loss of $26 million or 72 cents per basic and diluted share in the same period in 2023. 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. Turning to forward guidance for 2025, the company expects full-year 2025 Gelmito revenues to be in the range of $94 to $98 million. This implies a year-over-year growth rate of approximately 8 to 12% over the $87.4 million in demand-driven Gelmito revenues in 2024, which excludes the $3 million in Creates Act sales reported in 2024. Full-year 2025 operating expenses are expected to be in the range of $215 to $225 million, including non-cash, share-based compensation expense of $11 to $14 million. The anticipated increase in full-year operating expenses is primarily driven by the planned Salesforce expansion and additional commercial and medical activities to support the UGM-102 as well as the advancement of our UGN 103 and UGN 104 clinical programs. We are now ready to open the call for questions. Operator?

Thank you. To ask a question at this time, please press star 11 on your telephone and wait for your name to be announced. To withdraw your question, please press star 11 again. One moment for our first question. And our first question is going to come from the line of Tara Bancroft with TD Cal, and your line is open. Please go ahead.

Great. Thanks. This is Nick on for Tara. You noted on the call that you anticipate approval in the recurrent setting. Do you anticipate that UGN-102 could still be used in the about 10% of patients or so that are ineligible for surgery, which would be the frontline setting? And would this then require it to be used off-label? Thanks.

Yeah. Hi, Nick. It's Liz. Yeah, 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. Cause that's really what it comes down to is really more of a situation of making sure that they can get paid for it. So, you know, as we've talked about before, we thought, you know, 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. And it doesn't change our revenue projections and be really clear about that. So we still believe that the medicine 102 will be over a billion dollars revenue. And that doesn't change that. And it never did. It was more of exactly what you're talking about. Like we wanted 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 a TRBT for diagnostic purposes, but there are a handful of patients that physicians 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, and physicians have told us they would like to be able to make that choice and not the FDA. it was clear in the conversation that we had with them. And we had discussed it internally and knew that if they did go there, it's better for us, frankly, to go into the ODAC aligned with them on that so that we don't spend time in the ODAC, you know, going back and forth on that. And that we also don't risk, you know, a vote because, a negative vote because, you know, panelists say, well, I don't want the newly diagnosed. So, this obviously makes it a smaller patient population, but not really smaller from a business opportunity. But to your point, it would be up to the physician to work with the payer and the patient for them to get reimbursed. And, you know, we were obviously also, you know, think about whether we should do some clinical work in this space or not, but it's a very small a financial opportunity, again, just a matter of being able to help physicians make it easier for them to use.

It's very clear. Thank you very much. Thanks, Nick.

Thank you, and one moment for our next question. Our next question will be coming from the line of Michael Schmidt with Guggenheim. Your line is open. Please go ahead.

Hey, good morning. Thanks for taking our questions. On UGN 102, as you think about the potential FAA approval later this summer in June, how should investors think about the initial launch trajectory, perhaps relative to Gelmido or other potential benchmarks? Are there any analogs that we should look at? Yeah, how should we think about pricing, again, of one or two relative to Joe Mito, and would you expect any meaningful channel inventory builds early this year?

Thanks for the question. I'll turn it over to David Lin, our chief commercial officer, to answer those questions. David.

Yeah, thanks for the question. In terms of launch trajectory, we intend to, like we mentioned, we're going to continue educating our physician provider universe and 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 gel mito. While the absolute numbers would be larger because of the patient population, the overall shape we are modeling very similar to that of gel mito because there's a lot of similarities in terms of the operational considerations. On your question with regard to pricing, I think we continue to think of pricing in the $18,000 to $19,000 per dose. However, we continue to do research with payers to refine our assumptions, but that's how we're thinking about it for right now.

Great. Thank you.

Thank you. Thank you. One moment as we move on to the next question. Our next question is going to come from the line of Regaram Silvarahu with HC RainRite. Your line is open. Please go ahead.

Thanks so much for taking our questions. Firstly, with respect to UGN 102 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 launch when you will have the generic j code and once you actually have the specific j code in january of 2026 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 appear to be progressing in the ugn 103 program and if you still expect to be in a position to report data from that trial either next year or in 2027. Thank you.

Yeah, 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 UGM-103 and timing. So, David.

Yeah, 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-day to 60-days for a provider to be reimbursed. And that number does cut down by about half when we have a unique, permanent, miscellaneous JCODE, 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 period. And so we would continue to provide the same level of support as we are now, just to a broader audience.

Well, let me, I just want to add a couple of things that we will have services to get physicians through that time period. So like we did with John Mito, we'll have a longer dating, so they don't have to put the money out before they get reimbursed as well as a hub. And the other thing that I'll comment on is we also expect, like we saw with John Mito, that the initial uptake from a site of care perspective will be more in the hospital and the institutions. because the pharmacy takes the risk at that point in time and not the private practice. So where the JCO becomes more challenging is really the private practices who are concerned about putting out that kind of money and 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're affiliated, and they would conduct the therapy at that place. So again, as we mentioned earlier, as David mentioned earlier, I think you can look at Jalmaito in the initial couple of first 18 months. I would not look at Jalmaito post those 18 months because we do believe that the opportunity is far greater for UGM-102 and we should see an acceleration that's greater than we see with Jalmaito. But the first couple of years of Jalmaito, if you see, In our first year, we sold around the same six months, almost $15 million in revenue, and then it went up to almost $50 million in the full year following. So I would use that as a good analog for the first 18 months. So hopefully that helps.

Well, what I would also mention, of course, is for those who remember, you launched Gelmido in the middle of a pandemic, and that will clearly not be the case with 102.

Exactly. Absolutely. But, you know, like if you just take into consideration, and I'm not suggesting the same amount of revenue, but to David's point earlier, it's a much bigger patient population. The price may be, you know, a little bit less, but you can see at 10 times the size, even if gel mito were the analog, it would still be a very positive for the first few months, you know, of our of the launch, but you're absolutely right. We launched into a pandemic and hopefully, knock on wood, everybody, we won't be having a pandemic in 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 on 103. Mark?

Yeah, thanks, Liz. With respect to 103 and that the trial is the utopia trial, we're anticipating complete enrollment this year, data in 26 and approval in 27. So it's sort of a lockstep progression, but things are going well, and we're very optimistic that we're going to be able to keep to that timeline. Thank you very much.

Thank you. And one moment as we move on to the next question. And our next question is going to come from the line of Leland Gershall with Oppenheimer. Your line is open. Please go ahead.

Good morning, and thanks for the update and taking our questions. Just one from us. Just teeing off the earlier question about examining treatment-naive patients with low-grade, just wondering if you get in the ongoing trial with 103, if you would look to possibly amend that or if you would look to do further study in treatment-naive for the benefit of 103's eventual label. Thank you.

Yeah, it's a great question, Leland. And to be honest with you, this just happened last week, so we haven't spent a lot of time thinking about it. I think at the end of the day, it would more likely be around generating data in real-world use, maybe like a registry or through an IIR. But because, as I mentioned, the opportunity is fairly small, although the good news with UGM-103 is that we would be moving to our patent protection on that medicine will be 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 as close to UGM-102 as possible, 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 UGM-102. So you want to keep that study as quickly as possible, but we'll evaluate UGM-103, just like we've been talking about, we'll move 103 into high-grade disease. We'll look at other areas where we can study UGM-103. 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 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 that, you know, physicians just don't, you know, want to or patients don't want to go to surgery. But it's a great question. We'll have to give it some more thought from that perspective.

Thanks. And I'll just actually slip in a quick second. Just in terms of the pipeline, following the recent update on ICDB1042 and other collaborative agreements, just wondering if you have any plans to share more there, either data or more about the collaborations in 2025 and also 301, if we 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 are early studies. They're really The first question is, can you put the drug in the gel? Does it work? Does it, you know, does it provide the benefit that we think it does? So, we'll do 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 UGN 301 and 1042?

Yeah, thanks. So, with respect to 1042, this year is IND-enabling studies, so we'll be focused on that formulation, et cetera, and Obviously, if we have notable output from that, we would share that. But as Liz points out, it'll probably be next year before we have substantive data to share. And it's early in that program. With respect to 301, we did announce the monotherapy data at the SUO this past year. We actually, as everyone knows, have combination arms in that trial, which is a phase one trial combining 301 with our TLR7 agonist 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.

Super.

Thanks very much.

Thank you. And one moment as we move on to the next question. Our next question is going to come from the line of Paul Choi with Goldman Sachs. Your line is open. Please go ahead.

Hi. Thank you. Good morning, and thanks for taking our questions. I want to revisit pricing for 102 for a moment, and I just want to ask, given the impressive durability that the InVision data has shown relative to the total all-in cost for repeat turbots, have you sort of stress tested maybe potentially higher pricing and just sort of your pair reactions on this for 102 here? Just again, given the durability and potential longer-term reduction in cost, any color there would be great. And second, with 103 potentially launching as early as 2027, can you comment on how you're thinking about positioning 102 versus 103? Would there be a switch strategy, or would you just sort of fade out 102 in favor of 103 given the longer IP considerations there and just how you're thinking about the potential return on 102 if you do think about a switch strategy? Thank you very much.

Yeah, great questions, Paul. And I can tell you that we are revisiting. We had already, there's research underway because the pricing research we had done was before the impressive data to your point, durability data. So we are looking at that. We do believe that there's an opportunity to increase that slightly. So we will definitely be looking at that. And I'm sorry, your second question, remind me again.

Yes, sure, Liz. Just how you're thinking about positioning 103 versus 102, apart from IP, and just, you know, are you going to fade it out, 102 out? And, you know, just how you're thinking about the potential return profile for 102 if you do switch to 103?

Yeah, no, absolutely. Sorry. But yes, what we would do is we would, as soon as 103 is approved, we would likely wait for the J code, right, to get, so there's no concern about reimbursement. But then after that, we would actually fade out UGM-102 and we would take UGM-102 off the market and shift all of the business to UGM-103. And what that provides us is that 102 won't be on the market, so there won't be any automatic substitution or there won't be interchangeability. So if a generic or someone came in at post-2031, they 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 102 for them to write. And again, it'd 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 Jaumato. And 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 102 is on the market or not. And we're obviously just shifting the information that we have for Jalmido to UGM-102 because Jalmido is the only one right now that, you know, that generics have, you know, obviously since 102 isn't on the market. But again, 102 would not be, you know, would not be on the market for the generic companies to be able to compare to. So I hope that helps.

Got it. Okay. Thank you very much. Thanks. Thanks, Paul.

Thank you, and one moment for our next question. Our next question comes from the line of Aiden Husanov with Lattenberg. Your line is open. Please go ahead.

Hi, good morning, everyone. Thank you for taking questions, and congrats with the progress this quarter. A question I have is regarding the preparedness, commercial preparedness and infrastructure. So I think you mentioned the increase of reps from 52 to 83. And your current reps, obviously, like Joe Mito, it's making $100 million. And potentially, Eugene, 102, I think your guidance is building billion dollars in the peak sales. So can you help us understand the sort of economies of scale of increasing from 52 to 83, given that it's actually 10 times more potential peak sales? So maybe you can help us understand this from commercial preparedness perspectives.

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 bigger opportunity?

Yeah, that's a great question. So our analysis to increase the size of our commercial footprint from about 52 territories to around 83 territories is really hinged on the patient epidemiology And, you know, one important thing to note is that with gel mito and the low-grade UTUC, you know, with something like 6,000 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 NMIBC, what we hear from customers is that they are seeing, they know who these patients are, and the vast majority of urology practices do see these patients. And so the sizing of 83 territories allows us to get to the vast majority of treating physicians and practices. So it's something like roughly 85% of the market's covered. So we are really hitting the sweet spot in learning from our experiences with gel mito, and that the frequency of our visits does make a difference. And so we're increasing that. And importantly, the patients are in these practices. So we feel very good about the size of our 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.

Yeah, and the only thing I'll add is that in addition to the 83 reps, you know, as David talked about, we have nurse educators, we have medical science liaisons for peer-to-peer, we have operations managers that 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, it's these other roles that we have found to be very critical in the really comprehensive support system for physician offices. So given the entire field organization is much greater than 83, we feel really good about the number and where we are. Thank you. Thanks so much. Thank you.

Thank you. And I'm showing no further questions at this time, and I would like to hand the conference back to Liz Barrett for any further remarks.

Great. Thanks, everybody. Just want to say thank you. It's been a very busy year in 2024. We've already turned the page in 2025. You know, will be the most transformational year for our company. We're excited about the opportunity for UTM 102. to bring that to patients. And we look forward to providing more updates as things happen throughout the year. So I appreciate everyone joining. We can disconnect now. Thank you.

This concludes today's conference call. Thank you for participating and you may now disconnect. Everyone have a great day.