UroGen Pharma Ltd. Price & Performance (URGN)

Thank you, operator. Good morning, everyone, and welcome to UroGen Pharma's fourth quarter and full year twenty twenty four 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 12/31/2024. The press release can be accessed on the Investors portion of our website at uragen.com. Joining me on the call today are Liz Barrett, President and Chief Executive Officer Doctor. 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-one hundred and two, if approved. Anticipated data, regulatory filings and decisions UGN-one hundred and two being the primary growth driver for UroGen, if approved, future R and 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 UroGen 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 UroGen 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 for UGN-one hundred and two our investigational product for intermediate risk low grade non muscle invasive bladder cancer. Ahead of schedule. With FDA review underway and a PDUFA target date, of June 13, 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-one hundred and two's safety, efficacy and paradigm changing potential. Our commercial product, JOMYTO, continues to grow Additionally, we strengthened our leadership team ensuring we have the expertise and vision to drive UroGen'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-one hundred and two NDA submission. [indiscernible] Envision demonstrated a compelling complete response rate and unprecedented durability. As a reminder, the CR rate at three months stood as an and the twelve month duration of response was an unprecedented eighty two point three percent by CAPA Myer 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 eighteen month duration of response data from Envision and note that these results remain consistent with our previous Kaplan Meier and estimates. With one hundred and one patients now followed for at least eighteen months following CR, or twenty one months post therapy start.

The updated duration of response is eighty point six percent. By Kaplan Meier analysis. The median follow-up time for these patients has now extended to eighteen point seven months after three months CR, up from thirteen point 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 in our one hundred and twenty day update and they will be part of the submission. The durability of response is critical for a disease with a historically high recurrence rate.

By extending disease free periods, UGM-one hundred and 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 ODAC.

They previously indicated the meeting will take place in May and we are waiting 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-one hundred and two is 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 then the potential of UGM-one hundred and two to address a 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 a broader medical community.

If approved, UGM-one hundred and two will become the first medicine for this patient population introducing a potentially paradigm shifting solution for this disease. An approval of UGM-one hundred and two will be transformative for UroGen as it represents a significant market opportunity. A population nearly 10 times larger than the market for JALMAYDO. This translates to a total addressable market of more than $5,000,000,000 Importantly, our ability to identify and target physicians and their patients for UGM-one hundred and two will be easier. Unlike low grade upper tract urothelial carcinoma, which is a dispersed rare disease, low grade intermediate risk non muscle invasive bladder cancer is widespread spread and managed by nearly all urologists. UGM-one hundred and two is designed for seamless integration and to out The ease of use creates the opportunity for physicians to expand their practices and enhance patient care. JAMAITO generated net product revenues of $90,400,000 for the full year 2024. Compared to $82,700,000 for the prior year. The increase of $7,700,000 year over year was primarily driven by increased underlying demand for JALMITO. Partially offset by a decrease in creates ax cells and an increase in 340B charge backs.

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 region 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 twenty twenty four, 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 ten forty two from Econavier, This next generation investigational oncolytic virus represents an exciting opportunity in cancer care.

With its unique mechanism ICBB1042 is designed to selectively target and destroy tumors [indiscernible] 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.

UroGen ended 2024 with a strong balance sheet. Holding $241,700,000 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-one hundred and two later this year. I will now turn the call over to Mark Schoenberg, our Chief Medical Officer a clinical update. Mark? Thank you, Liz. Beginning with the NDA for UGN-one hundred and two, Our clinical and regulatory teams are fully engaged in preparing for the ODAC meeting where UGN-one hundred and two 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 UGN-one hundred and two represents a fundamental change in how we approach this disease. Moving away from repetitive surgical procedures, have been the standard for decades. We feel confident heading into this discussion. Urologists appreciate the need for alternative treatment options that could potentially provide a longer treatment and recurrence free survival In UGN-one hundred and two, 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-one hundred and two continues to grow. Liz highlighted the latest duration of response data from Envision showing an impressive eighty eight point six percent duration of response at eighteen months for those patients who had achieved a complete response of 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. Envision trial results were recently published in the February print edition of the Journal of Urology. And we're also presented at the Society of Urologic Oncology or SUO Annual Meeting, which took place in Dallas in December. At SEO, we also had the opportunity to present long term follow-up data from the OLYMPUS trial, which of approximately four years in patients who had achieved a complete response with GelMyto These data further reinforce GelMyto'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 JL Mito were published in urologic oncology.

This long term study evaluated fifty six patients from 15 high volume centers who achieved complete responses with GelMyto, demonstrating a recurrence free survival rate of sixty eight percent 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 GelMyto in a broad patient population. Turning now to the pipeline. We have a comprehensive lifecycle management plan for GelMyto and UGN-one hundred and two. Enrollment continues in the Phase three Utopia trial, which is evaluating UGN-one and our next generation product for low grade intermediate risk NMIDC. EUTOPIA is a single arm multicenter study with a protocol similar to the ENVISION trial. Low grade intermediate risk disease patients with recurrent disease are receiving UGN-one hundred and three 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 UGN-one hundred and four our next generation formulation of GelMida, and expect to commence a single arm Phase three study in the first half of twenty twenty five.

In February, we were pleased to announce the acquisition of ICBB ten forty two, a next generation oncolytic virus developed by Iconovir. This addition meaningfully enhances UroGen's pipeline by introducing a highly innovative approach to selectively targeting and destroying cancer cells while simultaneously activating a robust antitumor immune response.

Ten forty two 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 ten forty two is advancing. With IND enabling studies expected to begin this year. We intend to evaluate several modes of administration. Including delivery using our proprietary RTGEL technology. While our initial focus will be on bladder cancer, we anticipate exploring ten forty two'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 '29 in Las Vegas, Nevada. [indiscernible] 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 Doctor. Sandeep Prasad the Principal Investigator of the UGN-one hundred and two trial. Now over to David Lin 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-one hundred and two. The upcoming launch would mark a pivotal moment UroGen'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 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-one hundred and two.

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 are focused on three key priorities in our preapproval 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-one hundred and two. 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 JALMIDO. And finally, are scaling our commercial infrastructure and capabilities to ensure we're appropriately sized to fully address the opportunity for UGN-one hundred and two. 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 [indiscernible] for healthcare professionals and their staff to ensure seamless integration of UGN-one hundred and two into treatment protocols. Additionally, we are preparing our engagement initiatives to inform both clinical practices and patients about UGN-one hundred and two's coverage options and reimbursement. While UGN-one hundred and two will initially be assigned a miscellaneous J 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-one hundred and two is as smooth as possible. 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. [indiscernible] Turning to JALMINDO, as Liz mentioned, the product delivered $87,400,000 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 3313% respectively. In 2024, compared to 2023. [indiscernible] 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 JOMYTO. These results continue to reinforce its important role in treating low grade upper tract urothelial cancer. We are continuing our high touch strategy with a focused effort on key accounts ensuring JALMAYDO remains a key part of our commercial portfolio. [indiscernible] we expand our sales force in preparation for the UGN-one hundred and two launch, the new representatives will also be promoting JumIDO, 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 UroGen entered 2025 from a position of financial strength.

At the close of 2024, cash, cash equivalents and marketable securities totaled $241,700,000 providing a solid foundation on our strategic initiatives. With the anticipated launch of UGN-one hundred and two later this year, we are well equipped to drive our company Turning now to our financial results. Jumayto net product revenues were $24,600,000 in the fourth quarter of twenty twenty four, compared to $23,500,000 for the same period in 2023. Underlying demand revenue increased by 15% partially offset by decrease in creates act sales which totaled $200,000 in the fourth quarter of twenty twenty four, compared to $2,400,000 for the same period in 2023. Jomitel net product revenues for the full year ended 12/31/2024 were $90,400,000 compared with $82,700,000 of revenue in 2023. Research and development expenses for the fourth quarter of twenty twenty four were $14,900,000 as compared to $11,300,000 for the same period in 2023. R and D expenses for the full year 2024 were $57,100,000 compared with $45,600,000 for 2023. The year over year increase was primarily driven by manufacturing expenses for our product candidates, regulatory expenses related to UGN-one hundred and two, and costs associated with the UGN-one hundred and three Utopia trial.

SG and A expenses for the fourth quarter of twenty twenty four were $34,900,000 compared to $24,600,000 in the same period in 2023. For the full year 2024, SG and A expenses were $121,200,000 compared with $93,300,000 2023. The year over year increase was primarily driven by UGN-one hundred and two commercial preparation activities. We reported non cash financing expense related to the prepaid forward obligation to RTW investments of $6,100,000 in the fourth quarter of twenty twenty four compared to $5,500,000 in the same period in 2023. Non cash financing expense related to RTW investments was $23,400,000 in the full year 2024 compared with $21,600,000 in 2023. Interest expense related to the outstanding $125,000,000 term loan facility with Pharmacon Advisors was $3,900,000 and $12,500,000 respectively for the fourth quarter and full year 2024 compared with $3,600,000 and $14,700,000 respectively for the fourth quarter and full year 2023. [indiscernible] Net loss was $37,500,000 or $0.8 per basic and diluted share in the fourth quarter of twenty twenty four compared with a net loss of $26,000,000 or $0.72 per basic and diluted share in the same period in 2023.

For the full year 2024, net loss was $126,900,000 or $2.96 per basic and diluted share compared with a net loss of $102,200,000 or $3.55 per basic and diluted share in 2023. Turning to forward guidance for 2025. [indiscernible] The company expects full year 2025 GelMyto revenues to be in the range of $94,000,000 This implies a year over year growth rate of approximately 8% to 12% over the $87,400,000 in demand driven GelMyto revenues in 2020 which excludes the $3,000,000 in Creatax sales reported in 2024.

Full year 2025 operating expenses are expected to be in the range of $215,000,000 to $225,000,000 including non cash share based compensation expense of $11,000,000 to $14,000,000 The anticipated increase in full year operating expenses is primarily driven by the planned sales force expansion additional commercial and medical activities to support the UGM-one hundred and two launch as well as the advancement of our UGN-one hundred and three and UGN-one hundred and four clinical programs. We are now ready to open the call for questions. Operator?

And our 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-one hundred and two could still be used in the about ten percent of patients or so that are ineligible for surgery, which would be at the frontline setting? And would this then require to be used off label?

Thanks.

Yes. Hi, Nick.

It's Liz. Yes, 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 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 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 un And we've it doesn't change our revenue projections, that would be really clear about that. So we still believe that the medicine 102 will be over $1,000,000,000 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 [indiscernible] for those few patients that they really don't want to put under because we all know that newly diagnosed patients they almost all of them get a TRBT for diagnostic purpose.

But 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 to be able make that choice and not the FDA. But 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 going back and forth on that and that we also don't risk a vote because negative vote because panelists say, well, I don't want to newly diagnosed. So this obviously makes it a smaller patient population, but not really [indiscernible] 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 we're obviously also think about whether we should do 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.

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

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.

Good morning. Thanks for taking our questions.

On UGN-one hundred and two, as we think about the potential FDA approval later this summer in June, How should investors think about the initial launch to JAK trajectory perhaps relative to Jell O Mito or other potential benchmarks? Are there any analog that we should look at? And then how should we think about pricing again of one or two relative to JELD MYITO 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?

Yes. 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 GelMyto. While the absolute numbers would be larger because of the patient patient population, The overall shape we we are modeling very similar to that of GelMyto because there's a lot of similarities in terms of the operational considerations. On your question with regard to pricing, I think we've been we continue to think 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.

Thank you. One moment as we move on to the next question. Our next question is going to come from the line of Regoram Silverahu with CHC Rainwright. Your line is open. Please go ahead.

Thanks so much for taking our questions. Firstly, with respect to UGN-one 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 launch when you will have the generic J code? And once you actually have the specific J code, in January of twenty twenty six? Just kind of spell out for us how the environment is going to change when you shift from one J code to another? 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-one hundred and three 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.

Yes, great question. So I'll ask David to the first question around reimbursement and then move to Mark to give you an update on UGM-one hundred and three and timing. So David, Yes.

Thanks again for the question there.

From a reimbursement perspective, as we stated in the initial six months, assuming the June 13 action date. 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 fifty day to sixty days for a provider to be reimbursed. And that number does cut down by about half 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 period. And so we 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. We will have services to get physicians through that time period. So like we did with JALMAYTA, we'll 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 JAMAIO 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 the private practice. So where the J code 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 the therapy at that place. So again, as as we mentioned earlier, as David mentioned earlier, I think you can look at JALMAYTO in the initial couple of first eighteen months. I would not look at JALMAYDO post those eighteen months. Because we do believe that that the opportunity is far greater for UGM-one hundred and two and we should see an acceleration that's greater than than we see with Jomitra. But the first couple of years of Jomitra, if you see in our first year, we sold 15 mill around the same six months almost $15,000,000 in revenue and then it went up to almost $50,000,000 in the second in the full year following. So I would use that as a good analog for the first eighteen months. So hopefully that helps.

Well, what I would also mention, of course, is you launched GelMyto in the middle of a pandemic. Yes. This will clearly not be the case with 102. Exactly.

Absolutely. But 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 a little bit less but you can see at 10 times the size even if if Jomida were the analog, it would still be a very positive for the first few months of our of the launch. But you're absolutely right. We launched into a pandemic and hopefully, not to put everybody, we won't be having a pandemic in twenty twenty twenty five 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 want three, Mark.

Yes.

Thanks, Liz. With respect to 103 and the trial is 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 be able to keep to that timeline.

Thank you very much.

And our next question is going to come from the line of Lee Linger Rheal 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 other question about examining treatment naive patients with low grade Just wondering if you give 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 100 and three's eventual label? Thank you.

Yes, 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. 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-one hundred and three is that we would be moving to our patent protection on that medicine will be until through 02/1941. 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-one hundred and two 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 UGN-one hundred and two. So you want to keep that study as quickly as possible. But we'll evaluate UGN-one hundred and three just like where you've been talking about we'll move 103 into high grade disease.

We'll look at other areas where we can study UGN-one hundred and 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 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 physicians just don't want to or patients don't want to go to surgery. But it's a great question. We'll have to give 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 ICBB 102, 142 and other collaborative agreements. Just wondering if you have any plans to share more, their either data or [indiscernible] more and more about the collaborations in 2025 and also 03/2001 if we might see more reveal from that ongoing development? Thank you.

Yes. 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 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-three zero one and ten forty two?

Yes, thanks. So with respect to October, this year is IND enabling studies. So we'll be focused on that formulation, etcetera. And obviously, we have notable output from that, we would share that. But as Liz points out, it will probably be next year before we have substantive data to share. And it's early in that program. Respect to 03/2001, we did announce the monotherapy data at the SCOO this past year. We actually, as everyone knows, have combination arms in that trial is a Phase one trial combining three zero one with our TLR7 agonist two zero one. As well as with gemcitabine. We have seen some interesting data with respect 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 just want to ask, given the impressive durability that the Envision data has shown relative to the total all in cost for repeat turbines. Have you sort of stress tested maybe potentially higher pricing and just sort of your payer reactions on this for 102 here?

Just again given the durability and potential longer term reduction in costs 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? Would you just sort of sort of fade out 102 in favor of 103 given the longer IP considerations there and just how you're thinking about the potential potential return on 102 if you do think about a switch strategy Yes, 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 at that and 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 going to fade it out 102 out and just you're thinking about the potential return profile for 102 if you do switch to 103?

Yes. 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-one hundred and two and we would take UGM-one hundred and two off the market. And shift all of that the business to UGM-one hundred and three. And 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 02/1931, 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 Jomato. 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 JAMAITO to UGM-one hundred and two.

Because JALMAYTO is the only one right now that generic have obviously since 102 isn't on the market. But again, 102 would not be would not be on the market for the generic companies to be able to compare to So 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 Eden Husenov with Ladenburg. Your line is open. Please go ahead.

Hi, good morning, everyone. Thank you for taking questions and congrats for 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 selling John Mito making $100,000,000 and potentially, EUGEN-one hundred and two, I think, your guidance is $1,000,000,000 in the PIK sales. So can you help us understand sort of economies of scale of increasing from 52 to 83 given that it's actually 10x more potential peak cells. So maybe you can help us understand this from commercial preparedness 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 bigger opportunity.

Yes. 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 one important thing to note is that with JAL MYTO and the low grade UTUC, with something like six thousand patients in a year that might present, the likelihood of any one urologist seeing more than one of these is 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 80 roughly 85% of the market is covered So we are really hitting the sweet spot in learning from our experiences with Yelp and that the frequency of our visits does make a difference. 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.

Yes. 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 operations managers help with the operational lift and logistics pieces of it. And we've got account directors and field reimbursement taken 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 about the number and where we are.

Thank you.

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. I just want to say thank you as It's been a very busy year in 2024. We've already turned the page in 2025 will be the most transformational year for our company. We're excited about the opportunity for UGM-one hundred and two to bring that to patients and we look forward to providing more updates as things happen throughout the year. So appreciate everyone joining.

Everyone have a great day.