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Good day. Thank you for standing by. Welcome to the UroGen Pharma Q1 2026 results earnings call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question-and-answer session. To ask a question during the session, you will need to press star one one on your telephone. You will hear an automated message advising your hand is raised. To withdraw your question, please press star one one again. Please be advised that today's conference call is being recorded. I would now like to hand the conference over to your first speaker today, Vincent Perrone, Senior Director of IR.

Thank you. Good morning, everyone, and welcome to UroGen Pharma's 1st quarter 2026 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 quarter ended March 31, 2026. The release can be accessed on the investors portion of our website at investors.urogen.com. Joining me today are Liz Barrett, President and Chief Executive Officer; Dr. Mark Schoenberg, Chief Medical Officer; and Chris Degnan, Chief Financial Officer. On today's call, we will be making certain forward-looking statements.

These may include statements regarding our ongoing commercialization activities related to ZUSDURI and JELMYTO, our ongoing and planned clinical trials and non-clinical trials, commercial and clinical development milestones, market and revenue opportunities, our commercialization strategy and expectations, as well as anticipated data, regulatory filings and decisions, the importance of ZUSDURI's growth for UroGen's long-term strategy, the potential benefits of our products and product candidates, future R&D efforts and milestones, our corporate goals and 2026 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 UroGen disclaims any obligation to update these statements. I'll now turn the call over to Liz.

Thanks, Vincent. Good morning, thank you for joining us today. Before I provide our business update, I wanted to share that given the critical importance of a successful ZUSDURI launch, the board and I made the decision a few months ago that I would assume direct oversight of the commercial organization, resulting in the departure of David Lynn. For the past several months, I have engaged directly with our commercial team and key external stakeholders, and this change has enhanced our ability to remain agile, promote efficient decision-making, and leverage the expertise of our executive team. Now turning to our results. We are very pleased by our performance in the first quarter, highlighted by $29.2 million in ZUSDURI revenue. This represents more than 100% quarter-over-quarter growth.

As expected, the implementation of the permanent J-code in January marked a major inflection point. We are now seeing clear acceleration across key commercial metrics. The early momentum we discussed in the initial phase of the launch is now translating into expanded utilization and meaningful growth. Overall, the trends we are seeing are in line with our expectations and provide early validation of our commercial model. This progress reflects the differentiated value ZUSDURI brings to patients and physicians. As the first and only FDA-approved medicine for adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer, ZUSDURI offers a non-surgical treatment in a disease historically managed through repeated surgical intervention. ZUSDURI's profile as a primary chemoablative therapy represent a fundamentally different approach to treating these patients. Importantly, our clinical data has demonstrated unprecedented complete response and durability of response, offering patients meaningful recurrence-free periods and treatment-free living.

Let me provide more detail on the metrics we are tracking. We continue to see strong growth in both unique and repeat prescribers. By the end of the first quarter, we had 256 unique prescribers, up from 102 at year-end, and 103 repeat prescribers, up from 32. This is the most important indicators we track as it reflects growing HCP confidence and successful integration of ZUSDURI into routine urology practice. Importantly, these growth trends were consistent throughout the quarter and not limited to the immediate period following the implementation of the J-code. This gives us confidence in the durability of the launch and supports our expectation for continued growth as we move through Q2 and the rest of the year.

Patient enrollment forms, or PEFs, remain an important early indicator of demand, providing visibility into activity at the top of the funnel before it is reflected in new patient starts and revenue. In Q1, we saw continued sequential growth in PEF volume, which we believe reflects strong and expanded healthcare provider engagement. As we've shared, PEFs, new patient starts, and doses all significantly outpaced JELMYTO in Q1, and we expect continued growth across all measures over the course of the year. In terms of conversion, the cycle time from PEF to treatment initiation was approximately 45-60 days in Q4, which was expected as sites work through onboarding and workflow integration. In Q1, we continue to see improvement and expect this to continue over the course of the year, moving toward the 2-3-week range we see today with JELMYTO.

We also see a continued shift toward greater utilization in community practices. In Q4, the mix was approximately 60% hospital and 40% community, and we are now approaching a more balanced mix, closer to 50/50 at quarter end. Given that approximately 70% of the overall market opportunity resides in the community setting, we expect this shift towards community practices will continue and will be an important driver of long-term growth for ZUSDURI. From an access and reimbursement perspective, we have open access across more than 95% of covered lives, and reimbursement confidence has significantly improved amongst practices with a permanent J-code versus ZUSDURI becoming effective on January 1st, 2026. The J-code has been a key catalyst for broader utilization in 2026, especially in the community setting. Looking ahead, we expect continued strong growth throughout 2026.

Our focus remains on expanding adoption in the community setting, driving depth of utilization in accounts who have used ZUSDURI, and continue to improve patient conversion timelines. In parallel, we are beginning to expand our commercial approach to more directly engage patients, including targeted awareness efforts, as we believe patients can be a key catalyst to drive adoption, and ZUSDURI is in a unique position of providing both recurrence and treatment-free living. ZUSDURI addresses an estimated $5 billion annual market opportunity in recurrent low-grade intermediate-risk non-muscle invasive bladder cancer, and we believe its differentiated clinical profile positions it to capture a meaningful share of that market. As adoption continues to build, we see ZUSDURI as a foundational treatment for adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer patients with the potential to evolve into a blockbuster therapy with peak annual revenues exceeding $1 billion.

Turning to JELMYTO, we reported revenue of $21.7 million in the first quarter and continue to see a stable, predictable demand profile. We are also continuing to add new users, reflecting sustained confidence among urologists and remain on track to achieve our 2026 sales guidance of $97 million-$101 million. We continue to advance our pipeline, including UGN-103, our next-generation mitomycin-based intravesical therapy, where we will have established a clear regulatory pathway for adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer. We remain on track for our NDA submission in the second half of 2026, with potential approval in 2027. We also plan to expand this product into additional bladder cancer settings as part of our broader lifecycle strategy.

More broadly, as leaders in urooncology, we believe that non-muscle invasive bladder cancer patients need options, and we are committed to developing multiple modalities to address the significant unmet need in this space. Mark will provide more detail on our pipeline in a few moments. Finally, we have a strong balance sheet with approximately $140 million in cash equivalents, and marketable securities as of March 31st, supported by the refinancing of our term loan with Pharmakon Advisors during the quarter. This provides us with the flexibility to fully support the ongoing launch of ZUSDURI while continuing to invest in our next-generation pipeline with cash runway to and through profitability. Overall, we believe we are well-positioned to execute on our strategy, build on our current momentum, and deliver meaningful outcomes for our patients while generating long-term shareholder value.

I will now turn the call over to Mark for a clinical update. Mark?

Thank you, Liz. The American Urological Association annual meeting will take place May 15th to 18th in Washington, D.C. UroGen will have a significant presence there, and we believe this is an important opportunity to engage with both community and academic urologists and further discuss the clinical value of ZUSDURI and JELMYTO. For UroGen, the national AUA meeting represents a highly relevant and meaningful forum to continue building awareness and healthcare provider engagement. Bladder cancer will be a central focus of this year's meeting, and it's important to clearly define where ZUSDURI fits within the evolving treatment landscape for NMIBC. In intermediate-risk disease, the primary clinical challenge is the management of recurrence rather than progression. Patients commonly experience multiple recurrences, requiring repeated TURBT procedures under general anesthesia over time, which contributes to a significant cumulative treatment burden.

Accordingly, both patients and physicians are focused on strategies that reduce the frequency of interventions and enable a more rapid return to normal daily activities. ZUSDURI was specifically designed to address this need. Its clinical benefit is driven by both its efficacy and mode of administration. In the phase III ENVISION trial, which supported its FDA approval, ZUSDURI demonstrated a robust complete response rate of approximately 80% at 3 months, and importantly, durable outcomes over time. At 24 months, the probability of remaining event-free following complete response was approximately 72% based on Kaplan-Meier analysis. These data were recently published in The Journal of Urology and will be featured in a podium presentation at the upcoming AUA Congress. Importantly, median duration of response has not been reached in the ENVISION study at a median follow-up of 23.7 months after a 3-month complete response.

From a clinical perspective, this level of durability is meaningful as it has the potential to interrupt the cycle of recurrences and decreases patients' treatment burden. In practical terms, it translates into longer recurrence-free intervals and extended periods without treatment. Equally important is how ZUSDURI is delivered. It is administered as a finite 6-dose chemoablative regimen in the outpatient setting without the need for surgery or ongoing maintenance therapy. In our experience, this allows for straightforward integration into routine clinical practice without significant changes to workflow or infrastructure. This approach is distinct from many therapies currently in development, which are typically evaluated in the adjuvant setting and administered following TURBT. These regimens often involve induction and maintenance therapy over extended periods, in some cases up to 1 year. ZUSDURI, by contrast, is designed as a primary nonsurgical therapy with a total treatment duration of 6 weeks.

Taken together, this approach represents a meaningful shift in how this disease can be managed, offering durable disease control with a finite course of therapy while reducing treatment burden and enabling extended recurrence-free and treatment-free living. As we continue to gain real-world experience, understanding how these clinical benefits translate into routine practice is increasingly important. At the upcoming AUA annual meeting, UroGen will host a KOL panel focused on real-world experience with ZUSDURI, including patient selection, workflow integration, treatment patterns, and patient outcomes. This event will be webcast and accessible through the company's website, and we believe it will provide important clinical perspective on how ZUSDURI is being incorporated into routine practice. Turning now to the pipeline. UGN-103 is our next-generation mitomycin-based formulation for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer, developed to build on the foundation established by ZUSDURI.

It is designed to improve upon the current formulation with a shorter manufacturing process and a more streamlined reconstitution procedure, while also having intellectual property coverage into December of 2041. We plan to submit an NDA for UGN-103 in the second half of this year based on results from the phase III UTOPIA trial, which demonstrated a 77.8% complete response rate at 3 months, consistent with what we observed with ZUSDURI. We are aligned with the FDA that the NDA can be submitted with 6-month durability data, with plans to update the filing as 12-month durability data become available. 6-month durability data are expected mid-year, and if we receive FDA approval in 2027, we expect the permanent J-code could become effective as early as the beginning of 2028. We also see significant opportunity to expand UGN-103 beyond its initial planned indication.

We are actively pursuing development in high-grade NMIBC, as well as in the adjuvant setting for intermediate-risk disease, both of which represent meaningful opportunities to broaden the impact of this program. We plan to hold Type C meetings with the FDA in the second quarter of 2026 to align on the development plans for both studies, with the goal of initiating a phase III trial in high-grade disease before year-end and in the adjuvant intermediate-risk setting thereafter. UGN-104, our next-generation program for low-grade upper tract urothelial cancer, continues to progress in a phase III trial as planned, with enrollment expected to complete by the end of 2026. Finally, UGN-501 is our investigational next-generation oncolytic virus therapy being developed as a locally administered treatment for cancer.

UGN-501 was specifically designed and genetically engineered to act like chemotherapy initially, producing widespread tumor cell lysis with a subsequent immunomodulatory benefit, which we believe differentiates UGN-501 from other oncolytic viruses in development. We plan to submit an IND in the second quarter of 2026 and initiate a phase I clinical trial in NMIBC by year-end. Our nonclinical data support the potential for UGN-501 to be a differentiated oncolytic virus, demonstrating broad and consistent cytotoxic activity across a large panel of bladder cancer cell lines representing a range of tumor stages and grades. These findings reinforce our belief that UGN-501 has the potential to be best-in-class, highly active, locally delivered therapeutic approach in this setting.

The phase I trial will initially evaluate UGN-501 via aqueous intravesical administration. In parallel, we plan to explore additional modes of delivery, including an administration with our proprietary RTGel technology, which may enable prolonged dwell time and enhanced local activity. While our initial focus is bladder cancer, we believe this platform has the potential to extend beyond the genitourinary setting into additional tumor types over time. I will now hand it over to Chris to discuss our financial results.

Thank you, Mark. Q1 represents an important step forward as we begin to see the early commercial momentum of the story translate into meaningful revenue growth while continuing to manage our cost structure in a disciplined manner. At the same time, we remain focused on supporting the ongoing launch of ZUSDURI, advancing our pipeline, and maintaining the financial flexibility needed to execute on our long-term strategy. Now to our financial results. Total revenue was $51 million in the first quarter ended March 31, 2026, compared with $20.3 million in the first quarter of 2025. The 152% year-over-year increase was primarily driven by the commercial launch of ZUSDURI, and JELMYTO revenue growth also contributed to the increase.

Research and development expenses were $15.6 million in the first quarter of 2026, compared with $19.9 million in the same period in 2025. The decrease in R&D expenses was primarily attributable to the acquisition of UGN-501 in the first quarter of 2025 and ZUSDURI manufacturing costs, which we recognized as R&D expense in the first quarter of 2025 prior to receiving FDA approval. Selling, general and administrative expenses were $51.5 million in the first quarter of 2026, compared with $35 million in the first quarter of 2025. The increase in SG&A expenses was primarily attributable to ZUSDURI commercial activities, including the sales force expansion following ZUSDURI approval and higher brand marketing expenses, an increase in overall commercial operation costs and higher advisory costs, including fees associated with the Pharmakon debt refinancing.

We expect Q1 to be the high point of SG&A expense in the year based on phasing of activities and the one-time costs associated with the debt refinancing in the period. Financing expense related to the prepaid forward obligation to RTW Investments was $4.5 million for the first quarter of 2026, compared with $4.6 million in the prior year. Interest expense related to long-term debt was $4.2 million in the first quarter of 2026, compared to $4.1 million in the same period in 2025. The slight increase in interest expense was primarily attributable to the additional borrowings of $75 million in the first quarter of 2026 in connection with the Pharmakon debt refinancing, offset by the lower interest rate.

The company reported a net loss of $23.6 million, or $0.47 per basic and diluted share in the quarter ended March 31, 2026, compared with a net loss of $43.8 million, or $0.92 per basic and diluted share in the first quarter of 2025. As of March 31, 2026, cash equivalents and marketable securities totaled $140.3 million. Finally, turning to guidance. The guidance that we provided on the year-end call in March is unchanged. For the full year 2026, net product revenues for JELMYTO are expected to be in the range of $97 million-$101 million. This implies a year-over-year growth rate of approximately 3%-7% over 2025.

We are not providing formal sales guidance for ZUSDURI in 2026 at this time, given that the product is still in the early stages of its launch. Full year 2026 operating expenses are expected to be in the range of $240 million-$250 million, including non-cash share-based compensation expense of $20 million-$24 million. That concludes our prepared remarks. We will now open the call to questions.

Thank you. At this time, we will conduct the question and answer session. As a reminder, to ask a question, you will need to press star 11 on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. Please stand by while we compile the Q&A roster. Our first question comes from Tara Bancroft from TD Cowen. Tara, the line is open.

Hi. Good morning. Congrats on the great quarter. Love to see it. You know, with this quarter, it appears that you'll pretty significantly exceed the ADSTILADRIN's demand-driven growth that you previously pointed to as a solid analog for, you know, those six months post the permanent J-code. I'm wondering if you have any updated thoughts on how we should think about growth for the rest of the year from here. Maybe is there any other analog that we should look to instead from here? Thanks.

Hi, Tara. Thank you. I'm gonna ask Chris to comment, and then I'll add any other commentary.

Yeah, Tara, thanks for the question. To your point, I mean, we pointed to ADSTILADRIN, just to reground folks, where we looked at the first 6 months with the permanent J-code. You know, they saw a 220% step-up in their revenue. To your point, you know, given the performance in Q1, you know, we're tracking ahead of that analog.

Again, we're not guiding for the year, I mean, I think it's important to reiterate a few points from the call. One, that we're seeing, you know, consistent growth across all our commercial indicators. This wasn't a one-time step up with the J-code that we saw in January. These trends that we're seeing are progressing consistently throughout the quarter and into Q2, which gives us confidence that, you know, the underlying demand is building in a sustainable way. As Liz mentioned on the call, we do expect, you know, continued growth in Q2 and throughout the year, given the early stages of the launch.

Yeah. Unfortunately, Tara, we don't have a great analog, to be honest with you know, that we could, we could share with you. I think, you know, as Chris stated, you know, I think we feel good about, you know, where we are. You know, we expect to continue to grow. We do wanna caution everybody that, you know, quarter-over-quarter growth is not likely to be the same, you know, as we go forward as it was in the Q1 versus Q4 because of the J-code dynamics. We do expect to continue to see quarter-over-quarter growth. I wish we could give you an analog. I think, you know, we're happy with where we are. We'll continue to see growth and, you know, think we're in a good place.

Right now we're just not in a good position to provide any additional guidance beyond that.

Okay, great. Yeah, understand completely. Thanks so much for that.

Thanks. Appreciate it.

Thank you. One moment for our next question. Our next question comes from Kelsey Goodwin from Piper Sandler. Kelsey, the line is now open.

Perfect. Hey, thanks so much for taking our questions, and congrats on the really strong quarter. That's wonderful news. Two questions from us. First, could you provide more color on how many TURBTs these patients are receiving prior to getting ZUSDURI? You know, what kind of patients are getting ZUSDURI now and when patients recur? How do you get ZUSDURI to kind of be that first product that physicians reach for? Secondly, on reimbursement, now that physicians are getting more comfortable post-permanent J-code, I guess maybe could you provide some color on, you know, what kind of cost sensitivity you're seeing given ZUSDURI's priced, you know, relatively lower than some of the high-risk programs at about a $130K price range? Thanks so much.

Yeah. Hi, Kelsey. Great questions. You know, one, I can give you anecdotally, but we don't track obviously how many TURBTs. That information just isn't available. You know, what we're hearing in the beginning is most of the patients that are getting treated in the beginning are those that have had at least 2 or 3 TURBTs. Having said that, we do have physicians that have already adopted ZUSDURI as sort of their standard of care, for a recurrent patient. What I mean by that is they're looking, you know, we do have physicians who have treated several patients, you know, into the high teens. They are really adopting it across the entire paradigm of patients.

You know, I think we will get there and we wanna be very careful. That's one of the things we also were very careful with our sales team, is that we don't niche ourselves into those that have had multiple TURBTs. Keeping in mind that, you know, 23% have had 5 or more and 68% have had 2 or more. Even if we did have those patients, it's still a large number of patients, but we wanna make sure that everybody understands. Particularly if you look at our clinical study, a lot of those patients only had 1 or 2, we are seeing again. Initially it's the expectation, and this happens across all of oncology.

You typically start with your later line of patients and then move up after they see good results. That, that's kind of where we are with that. On the cost sensitivity, it's kind of an interesting position for us to be in because obviously the ones that you're talking about are all high-grade. We do get lumped in unfortunately with the-- when they talk about a high-priced drug, they are lumping us in there, so we have to continuously remind everybody, to your point, that our price is significantly less. We also want to bring, you know, that awareness as those high-priced drugs start to move into the low-grade space. You know, when we developed our pricing, it was specifically for the low-grade patients.

Also, you know, take into consideration the duration of therapy. Because one of the reasons that ours is $130,000 is because you only have 6 doses and you're done. You don't need to continue maintenance. Whereas you look at the other players in the market, both for high-grade and those coming into IR, they have maintenance therapy. You're talking about 6 doses versus 14+ doses. That also increases the price. You know, we hope that, you know, not only that physicians, payers see the value and the value price that we have, and I think we've been very responsible from that standpoint for the patient population that we're talking about.

Perfect. Super helpful. Thanks so much, and congrats again.

Thanks. Appreciate it, Kelsey.

Thank you. One moment for our next question. Our next question comes from Ami Fadia from Jefferies.

Hi. Thank you for taking our questions, and congrats on the quarter. Two from us. First, just following up on a prior question. Can you comment on 2Q demand trends versus 1Q so far, what you're seeing on the field? Whether you're seeing any acceleration early in this quarter. The second one, within the new prescribers, how does the mix break down between community versus academic? Are you seeing a meaningful differences in demand across these groups already early in this launch?

Yeah. Chris, you wanna comment and then I'll-

Sure. I mean, thanks for the question. In terms of Q2, I mean, obviously early stages of Q2, but I would say, you know, not necessarily acceleration, but just continued demand growth. As I said, you know, we saw continued growth month-over-month through Q1, I would say that trend continues into the early stages of Q2. In terms of mix, you know, as Liz mentioned on the call, you know, 60% of our business was in the hospital setting last year, and we've already now exceeded 50% mix in the community setting in Q1. That is a big part of our growth. We expect that to continue to shift more and more towards the community practices throughout the course of the year.

Just a reminder, you know, 65%, 70% of these patients are treated in the community setting. That's a big piece with the J-code being in place and opening up those practices for us.

I think it's also just important to note that community, very important, but also a lot of the academic centers who do have a lot of these patients, they also continue to come on board. We have some large academic centers that we've just received in the last month, the formulary, positive formulary decision. You'll see some new academic centers coming on board as well. It's a continuous thing, but, you know, obviously, most of these patients, low-grade patients do get treated in a community. As we grow community, but also important that we also support the institutions as they are big drivers also of the adoption. Thanks for your questions.

Thanks.

Thank you. One moment for our next question. Our next question comes from Michael Schmidt from Guggenheim. Michael, the line is now open.

Oh, hey guys. Good morning. Thanks for taking my question. Congrats on a great first quarter. Yeah, maybe just another follow-up on ZUSDURI. Could you just comment if you're seeing a change perhaps in the type of patients that are choosing ZUSDURI now over TURBT? I think initially you spoke about sort of preference by patients who are of high risk, surgery high risk or, you know, elderly type patients. I'm just curious if that's shifting a bit now that the product's been on the market longer. You know, maybe bigger picture, how do you think about the intermediate risk market evolving longer term with the potential entry of adjuvant therapies in the future post-TURBT? You know, how could that, you know, impact the landscape as you think about ZUSDURI use long term? Thank you.

Yeah. No, great. Michael, I love the word when you said, quote-unquote, "patients choosing." I will say that, yes, we are seeing across the board, different types of patients getting, being able to get ZUSDURI. I think your comment about that, I will also answer as part of your second question. What we are finding and what we're hearing, and this is anecdotal, right? I just wanna be very careful about that, is we are starting to see and hear about patients requesting ZUSDURI.

You know, we're hearing things like, "Oh, I want that gel stuff." Patients, as they're starting to hear more about that, one of the ways that we believe we can clearly differentiate ourselves versus the market as the market evolves, is given that we are the treatment that does not have surgery, yet we have very meaningful clinical results. When you talk to patients, they don't want another surgery. At the adjuvant setting, I believe that you'll always have those physicians who want to do surgery because they, you know, it's just, it's in their nature to cut it out and then come back with another therapy.

I think you're gonna see that patients are gonna be opposed to that, patients are gonna want to say, "Hey, let me see how this one works without surgery," because you can, you know, go back and have surgery. I'll give you an example. We just heard about a patient who had multiple recurrences and very close together, used ZUSDURI, and she did have two small lesions, which were able to be fulgurated in the office. I think more and more as you start to hear about that, then I think our drug will get used less in adjuvant. It does get used. We do know of physicians that are even using ZUSDURI right now after surgery.

Again, one of the biggest benefits we can provide and why we believe we will be the patient's choice for a treatment is because not only do you not have to have surgery, but you also don't have to have maintenance therapy. It's a clear differentiator for us. Given the results, you have to look at the complete response and the durability that we have without surgery. You know, to your point, I think it will continue to evolve. I think there'll be opportunity for others in this space. I think more companies and more drugs being introduced will help to grow the market.

You know, as we've talked about before, even given our, you know, the pricing of our medicine and the use of only 6 weekly doses, we still believe that we'll have over a billion-dollar revenue drug with only less than a 20% market penetration. Think there's plenty of room for the category and for the area to evolve, but I also believe that we have a clear differentiator versus anyone coming in. Especially even today when there's no one coming in in the near future. It's gonna be a couple of years before there's others coming in. Our ability to offer patients an opportunity to not go through surgery but still get very meaningful results is very critical.

Thank you. One moment for our next question. Our next question comes from the line of Raghuram Selvaraju from H.C. Wainwright & Co.

Thanks so much for taking my questions. Just 3 quick ones from us. Firstly, I was wondering if you could give us a sense of where you expect the timing between receipt of a patient enrollment form and finalization of reimbursement for ZUSDURI to be by the end of 2026, you know, given the impact of the J-code. Secondly, I was wondering if you could talk a little bit further about the community hospital contribution at steady state to the ZUSDURI revenue base, you know, just on a % basis, and also if there are any specific nuances between what you see as the receptivity at the community setting relative to the academic setting.

Lastly, I was wondering if you could just provide us with a few words on JELMYTO and what you see as the long-term future for that product, as well as the lifecycle management initiative with UGN-104. Can we expect, you know, some re-acceleration of JELMYTO uptake? Do you think that there is some incremental gain to be made on that front with that product? Perhaps most importantly, are you seeing some renewed interest in JELMYTO given the receptivity you've seen so far with ZUSDURI among prescribing physicians? Thank you.

I'm gonna actually go backwards if that's okay, Ram, and then I'll leave the last question for which is your first question, and I'll turn it over to Chris. On JELMYTO, what we expect is, as I mentioned in the remarks, to continue to see this sort of you know, predictable growth where we are. We will continue to see low single-digit growth. That's what we've been talking about. The good news is that we do see, continue to see new users of JELMYTO. The issue for JELMYTO always comes around finding the patients. As we go out and talk about ZUSDURI, when even before ZUSDURI may be on formulary, that they're under hearing about JELMYTO, we're getting new users using JELMYTO. Every quarter, we have new physicians using JELMYTO. We expect that to continue.

Again, the challenge there is really where the patient presents. You may have a doctor this quarter, and that doctor won't see another Jelmyto patient for 2, 3, 4 quarters. While we expect to continue this low single-digit growth, we also do expect there to be continued new users of Jelmyto, and I think ZUSDURI will help that, and we've talked about that before. With UGN-104 coming in, it will be interesting to see the data with UGN-104. The only reason I say that is because if you recall, the stricter rate for Jelmyto was high because of the way that the FDA re-required that we characterize that. We had some, you know, some physicians who see that and get a little bit worried about that.

Now that the nephrostomy tube is at least half of the usage and the clinical study, you know, we'll have to see how that comes out, you know, in the clinical study. Also given the long-term durability of JELMYTO, and we're seeing, you know, very similar results with ZUSDURI. I think all of those things, you know, point to our ability to continue to grow the low single digits for JELMYTO. You know, the fact that we'll continue to grow the number of doctors that we're calling on with ZUSDURI, and that will also help JELMYTO. On the community versus the hospital, where we end up, you know, my guess is gonna be more of a 60/40 situation where most of it's coming from the community because that's just where the patients get seen.

I mean, that's reality. Having said that, I don't want to negate the fact that the institutions are very important, and that's a lot of that is because once these patients have been, you know, treated multiple times, they tend to be sent to, you know, an institution or an academic institution. We also know that they tend to be high volume, you know, high volume accounts. While we expect ultimately, you know, the community bigger, we the institutions will always be a major part of ZUSDURI. We have some, you know, some institution physicians who have already become real champions and advocates of ZUSDURI, and as I mentioned before, using it on most of their patients.

They're seeing, I'm sure you heard last week with Dr. Chamy, you know, he's seeing more patients than he frankly thought he would that are appropriate for ZUSDURI. I think we're hearing that more and more. I think that's where we'll end up. I'll just ask Chris to talk a little bit about the conversion timing and where we expect it to be by end of 2026. Chris.

Yeah. Thanks, Ram. You from path to new patient start, as we talked about, you know, last year was roughly 45 to 60 days, and a lot of that.

Less so the benefit verification, which only takes, you know, a few days once it's submitted to the hub. It was more the operational pieces and also as, you know, more use was in the hospital last year, just getting on hospital formulary, et cetera. We do expect, you know, as this gets adopted into clinical workflows that our time to conversion is going to compress. We did see that already in Q1. Average time to conversion in Q1 was 30-35 days. We're starting to see that walk down, and we expect ultimately in steady state to be closer to where we are today for JELMYTO, which is 2-3 weeks from path to new patient start.

Great. Thank you so much, and congrats on all the recent progress.

Thanks, Ram.

Thank you. Our last question comes from Paul Choi from Goldman Sachs. Paul, the line is now open.

Thank you. Thanks for taking our questions. Let me add my congratulations on the good results. Liz, I was wondering if you could maybe provide some color on where the ZUSDURI update is happening. Specifically, what is the sort of percentage of overlap with existing Gemcito users versus prescribers who are just new and outside your current commercial base or prior commercial base? My second question for Mark is, I was wondering if you could expand a little bit more on UGN-103 development plans and potentially an adjuvant trial that seems to be the direction of travel for, you know, some of your competitors, and just what that kind of trial in your mind might look like for UGN-103. Thank you.

Yeah, sure, Paul. Mark, would you like to start there?

Yeah, sure. Thanks, Liz. Thank you, Paul. Yes, we are excited about UGN-103's NDA submission this year and expect expected approval for the successor molecule for ZUSDURI. In terms of expanding the label or the indication into other aspects of the disease spectrum, we certainly are in the process of finalizing conversations about what trials would look like as adjuvant therapy for newly diagnosed intermediate risk disease and also for high grade, high risk disease. Both of those trial designs anticipate prospective randomized adjuvant therapy with a control arm. We are in the process of finalizing the details of those trials, and we anticipate initiating the high grade trial this year. That's our current plan.

Yeah. I think the only additional comment I'll make about that is, you know, I still hold to what I said earlier in the IR space, is that I think doing it without having to do surgery is a real benefit. Having said that, you know, because some physicians want to, it's probably in our best interest to at least generate some data of using ZUSDURI in the adjuvant setting. You know, it's one of the reasons we're doing, you know, what Mark was talking about. To go to your first question around Gemcito overlap, absolutely. You know, some of our initial users are Gemcito users, and we see today over 50% of the ZUSDURI users are Gemcito users.

That's not surprising, obviously, because, you know, the 95% of gemcito users are ZUSDURI, you know, Are potential ZUSDURI. The, you know, flip side isn't not necessarily the case given the rare nature of the, of upper tract, urothelial carcinoma. We're seeing again now, you know, in the beginning, I would say it was even higher. You know, we started out, some of our initial users were gemcito users, so probably 80%. Now it's, you know, a little over 50%. We're seeing both the gemcito and non-gemcito users using ZUSDURI. I hope that helps, Paul.

Yes, it does. Thank you very much, Liz.

Okay. Thank you.

Thank you. We have one last question. The last question will be from Leland Gershell from Oppenheimer. Leland, the line is open.

Great. Thanks for taking our questions, terrific to see ZUSDURI hitting its stride here. Just, Liz and team, wanted to ask, appreciate the additional launch metrics that you provided. Looks like you're making solid progress there on activated sites and prescribers. If you would, wondering if you could share with us where you may be sort of in the context of your overall, you know, rollout plan with respect to goals of, you know, of those various metrics. Thanks very much.

Yeah. Thanks, Leland, and thanks for the support. very, very early, you know, so we're nowhere near where we wanna be. you know, we have a target of 8,500 doctors, healthcare providers, and, you know, we're, as we talked about today, we've only got, you know, 300 unique prescribers, so we have a long way to go. I think that's great news, right?

It's good news for us because that means the opportunity, since we're already seeing the great results so far in Q1, we believe that those that have used it, we're getting very positive feedback, but we have a long way to go with new users, and we'll continue to add new users. I mean, our strategy is both breadth and depth because we also do know that those physicians who have already used it have more patients that they could use it on. You know, absolutely we have a long way to go. We're just in the very early stages of where we wanna be with penetration among docs. Long way to go. Very early in the early stages.

Great. Thanks very much.

All right. Thanks, Leland.

Thank you. I am showing no further questions.

Okay, great.

This concludes.

Yeah.

This concludes the question and answer session. I would now like to turn it back to Liz Barrett for closing remarks.

Thanks, and sorry about that. Just wanted to say thank you to everybody who have been supportive of us for a long time. I think we're finally starting to see the results that we've always known that we could bring. I think the most important thing that we really like to focus on is the impact that we're having on patients, because we really do believe if you do the right thing for the patients, the business and our shareholders will be rewarded for that. Thanks for all the support. Happy to continue to share progress as we, you know, get into Q2 and beyond. Thanks again for everybody's support, and we will talk to you guys soon. You can disconnect now, operator.

Thank you for your participation in today's conference. This concludes the program. You may now disconnect.

Good day, and thank you for standing by. Welcome to UroGen Pharma Ltd.'s fourth quarter 2025 earnings call. At this time, all participants are in a listen-only mode. After the speakers' presentation, there will be a question-and-answer session. To ask a question during the session, you will need to press 11 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press 11 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to Vincent I. Perrone, Senior Director of Investor Relations. Please go ahead.

Thank you. Good morning, everyone. Welcome to UroGen Pharma Ltd.'s full-year 2025 Financial Results and Business Update Conference Call. Earlier this morning, we issued two press releases, the first providing an overview of the refinancing of our debt facility with Pharma Advisors, and the second providing an overview of our recent corporate highlights and financial results for the fourth quarter and year ended 12/31/2025. Both releases can be accessed on the Investors portion of our website at investors.urogen.com. Joining me today are Elizabeth A. Barrett, President and Chief Executive Officer; Mark P. Schoenberg, Chief Medical Officer; David Lin, Chief Commercial Officer; and Christopher Degnan, Chief Financial Officer. On today's call, we will be making certain forward-looking statements. These may include statements regarding our ongoing commercialization activities related to Jelmyto and Zasturi, our ongoing and planned clinical trials and nonclinical studies, the commercial and clinical development milestones, market and revenue opportunities, our commercialization and long-term growth strategy and expectations, as well as anticipated data, regulatory filings and decisions, the potential benefits of our products and product candidates, future R&D efforts and milestones, our corporate goals, and 2026 financial guidance, among other things. These forward-looking statements are based on current information 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 UroGen Pharma Ltd. disclaims any obligation to update these statements. I will now turn the call over to Elizabeth A. Barrett, Chief Executive Officer.

Thanks, Vincent. Good morning, and thank you for joining us today. Our top priority is the commercial launch of Zysturi in recurrent, low-grade, intermediate-risk, non–muscle invasive bladder cancer, a pivotal step in advancing our long-term growth strategy. As we outlined in our earnings release this morning, we are encouraged by the early 2026 trajectory following the permanent J code becoming effective January 1. Zasturi revenue in 2025 was $15,800,000, reflecting early launch dynamics as we work through typical reimbursement and operations steps necessary to build the foundation for broader adoption. With a permanent J code now in place, a key barrier to adoption has been removed, facilitating more predictable patient access. Since that milestone, as expected, we have seen a clear acceleration across key launch indicators including the number of new and repeat prescribers, patient enrollment forms, and new patient starts. Overall, we are pleased with how the launch is unfolding in early 2026 and we are on track with the assumptions we have made around its trajectory. Zesturi addresses a large and underserved market, and based on our assumptions regarding market penetration, pricing, and physician adoption, we believe Zesturi has the potential to achieve greater than $1,000,000,000 in peak revenue. Importantly, Zasturi provides the first and only medication approved by the FDA that can provide patients with a primary office-based therapy that can result in extended recurrence- and treatment-free living. Turning to the rest of the business, Jelmyto generated net product revenue of $94,000,000 for the full year 2025, reflecting continued underlying demand growth. We are also advancing our pipeline in a disciplined manner. UGN-103, our next-generation formulation of Cisteri, demonstrated compelling complete response results in the Phase 3 Utopia trial, consistent with the ENVISION study. We remain on track to submit an NDA in recurrent low-grade, intermediate-risk, non–muscle invasive bladder cancer in 2026, with potential FDA approval in 2027. With a clear regulatory pathway established for UGN-103, and low-grade IR non–muscle invasive bladder cancer, we are evaluating its potential in additional bladder cancer settings including as an adjuvant in intermediate- and high-risk bladder cancer as part of our broader life cycle strategy. UGN-104, our next-generation formulation of Jelmyto, continues to progress through Phase 3 with enrollment expected to complete by 2026. Finally, following the refinancing of our term loan with Pharmacon, we have further strengthened our balance sheet and enhanced our financial flexibility. Together with our existing cash on hand, this refinancing provides additional nondilutive capital that supports our operating plan and allows us to continue executing our strategy in a disciplined manner. Importantly, our fortified balance sheet enables us to fully support the ongoing Zistory launch, advance our next-generation pipeline, and thoughtfully pursue life cycle management opportunities over time. We believe this approach positions us well to allocate capital responsibly and create long-term value for patients and shareholders. I will now turn the call over to Mark for a clinical update. Mark?

Thank you, Liz. As a reminder, the ENVISION trial, which supported approval of assessed duty, demonstrated an approximately 80% complete response rate at three months. Importantly, among those patients who achieved a complete response, the probability of remaining free at 12 months was approximately 80% by Kaplan-Meier estimate, and at 24 months was approximately 72% by Kaplan-Meier estimate. In practical terms, that translates to a substantial proportion of patients expected to remain disease free two years following treatment. Zesturia is delivered as a convenient six-dose regimen in the outpatient setting and does not require surgery or maintenance therapy. Taken together, these clinical and practical advantages support Cystoree's growing role for adults with recurrent, low-grade, intermediate-risk NMIBC and position it competitively within an evolving treatment landscape. I would note that what I am about to share reflects anecdotal feedback from early adopters and patient conversations rather than formal study outcomes. From those discussions, we are hearing that Zasuri is integrating smoothly into routine practice. Physicians have commented on the simplicity of administration and the ability to incorporate the six-dose regimen into existing patient workflows without requiring procedural changes or additional infrastructure. Several urologists have shared that following their first experience with Cisteri, the process becomes predictable and manageable within the normal flow of their clinic. We are also hearing encouraging feedback from the patient perspective. For individuals who have undergone multiple TURBT procedures, having a nonsurgical treatment option delivered in the outpatient setting has been meaningful. Physicians have described patients as being receptive to, and in some cases enthusiastic about, the opportunity to avoid additional surgery under general anesthesia while maintaining disease control. Taken together, while anecdotal, this early feedback reinforces our confidence in how Story's clinical durability and practical ease of use are translating into real-world adoption. Turning now to the pipeline, UGN-103 is our next-generation mitomycin-based formulation for adults with recurrent, low-grade, intermediate-risk non–muscle invasive bladder cancer. We are developing UGN-103 to build on the foundation established by Zasduri. UGN-103 is designed to improve upon the current formulation with a shorter manufacturing process and a more streamlined reconstitution procedure. Results from the ongoing Utopia Phase 3 trial demonstrated a 77.8% complete response rate at three months. We have aligned with the FDA that the data from this trial can support an NDA submission in this indication. We are planning to submit in 2026, which would position us for potential FDA approval in 2027. As Liz mentioned, we are evaluating life cycle management and pipeline expansion opportunities for UGN-103 beyond low-grade intermediate-risk disease. This includes exploration of its potential in high-grade NMIBC, as well as an adjuvant setting for intermediate-risk patients. We anticipate holding Type C meetings with the FDA in the second or third quarter to align on the development plans for these programs. We expect both studies to be randomized, controlled, and event-driven trials. Subject to regulatory alignment with the FDA, we intend to initiate the high-grade NMIBC study in 2026. We look forward to providing additional details as those plans are finalized. UGN-104, our next-generation program for low-grade upper tract urothelial cancer, continues to progress in Phase 3, with enrollment expected to complete by 2026. UGN-501 is our investigational next-generation oncolytic virus in development for high-risk non–muscle invasive bladder cancer. IND-enabling studies are well underway, and our goal is to submit the IND and initiate a Phase 1 clinical trial in 2026. While our initial focus remains bladder cancer, we see potential to explore this platform more broadly beyond the genitourinary system. Overall, we believe the recent progress made across our programs positions us well over the coming year with multiple clinical and regulatory milestones ahead. I will now turn the call over to David for the commercial update.

Thank you, Mark. I want to reinforce what Liz shared earlier. We are very encouraged by how the Zestiri launch is developing and it continues in line with our expectations. The commercial execution we are seeing reflects the significant groundwork laid throughout 2025, as we are beginning to see that preparation translate into broader engagement across the urology community. From FDA approval through year-end 2025, our focus was on intentionally building the commercial foundation required for long-term success. We expanded and trained the commercial organization, established reimbursement pathways, and worked closely with urology practices to support operational readiness ahead of broader adoption. Zestiri generated $1,800,000 in net product revenue in Q3 and $14,000,000 in Q4, bringing full-year 2025 revenue to $15,800,000. As discussed, these early quarters reflected the foundational launch during the miscellaneous J code period. As of 12/31/2025, we had 838 activated sites of care, with 102 unique prescribers and 32 repeat prescribers. Payer execution continued to support access, with over 95% of covered lives having open access to Zasturi by year-end. The permanent product-specific J code became effective on January 1, 2026, and since that time, we have seen a noticeable step up in adoption and utilization trends through January and February. It is still early days; however, the directional indicators are consistent with our expectations that reimbursement clarity would support broader uptake. Importantly, we are not seeing any material friction points in reimbursement, logistics, or treatment delivery. Just as important, we are beginning to see greater engagement from community-based urologists. As expected, many community practices were more cautious prior to the permanent J code going into effect, and we are now seeing growing participation as reimbursement processes normalize and confidence builds. We believe this shift toward increased community adoption will be an important contributor to growth as we move through 2026. We are also tracking the conversion timeline from patient enrollment form, or PEF, to dosing. We have previously said that conversion cycle was in the 45- to 60-day range, reflecting the onboarding and workflow integration typical of a new product launch. Over the course of 2026, we expect conversion time to narrow as sites gain familiarity and operational efficiencies improve, ultimately moving closer to the two- to three-week time frame we see today with Jelmyto. As we continue through 2026, our commercial organization is scaled to support the 8,500 in our target universe who treat approximately 90% of the low-grade, intermediate-risk non–muscle invasive bladder cancer patients in the U.S. Our focus remains on disciplined execution, expanding peer-to-peer education, supporting appropriate patient identification, and ensuring practices have the tools they need as adoption continues to build in a measured and sustainable way. We have also begun to increase our investment in patient awareness initiatives to complement our physician-focused efforts, ensuring that patients are informed about their treatment options. Turning to Jelmyto, it generated net product revenue of $94,000,000 in 2025. While growth has moderated for a more mature product, we continue to drive consistent engagement and steady demand across the treating community based in part on compelling, durable, complete response data. Importantly, the expansion of our commercial organization in support of Zasturi also enhances our overall urology presence, which we believe can provide incremental support to the Jelmyto franchise over time. I will now hand it over to Chris to discuss financials.

Thank you, David. Revenues were $109,800,000 for the year ended 12/31/2025, compared with $90,400,000 in 2024. The 21% year-over-year increase was driven by the commercial launch of Zastory in 2025 as well as increased sales of Jelmyto. Research and development expenses for the year ended 12/31/2025 were $67,100,000, compared with $57,100,000 in 2024. The year-over-year increase was primarily driven by higher manufacturing cost for Zasturi, which are recognized as R&D expenses prior to receiving FDA approval, costs associated with the Phase 3 trials for UGN-103 and UGN-104, and the acquisition of UGN-501, partially offset by lower clinical trial costs and regulatory expenses in connection with Sistori. Selling, general, and administrative expenses were $105,100,000 for the full year ended 12/31/2025, compared to $121,200,000 for the full year 2024. The year-over-year increase in SG&A expenses was primarily driven by Story commercial activities, including the sales force expansion following Zastore approval in 2025, as well as an increase in overall commercial operation costs. Financing expense related to the prepaid forward obligation to RTW Investments was $18,500,000 for the year ended 12/31/2025, compared with $23,400,000 in the prior year. The decrease was driven primarily by changes in underlying assumptions for remeasuring the effective interest rate. Interest expense on our prior $125,000,000 term loan facility with Pharmacont Advisors was $15,300,000 in 2025, compared with $12,500,000 in 2024. The increase was primarily attributed to the interest expense on the $25,000,000 third tranche of the loan that was funded in September 2024. We reported a net loss of $153,500,000, or $3.19 per basic and diluted share, for the year ended 12/31/2025, compared with a net loss of $126,900,000, or $2.96 per basic and diluted share, in 2024. As of 12/31/2025, our cash, cash equivalents, and marketable securities totaled $120,500,000. As Liz mentioned, today, we announced that we have entered into a second amended and restated loan agreement with Pharmacont Advisor providing for a senior secured term loan facility of $250,000,000, consisting of two tranches. The initial tranche of $200,000,000 is funded at closing and was used to refinance our existing $125,000,000 term loan facility and provide additional nondilutive capital. The agreement also includes a second tranche of $50,000,000, which may be drawn at our discretion through 06/30/2027, subject to customary conditions. All outstanding loans with Pharmacon will accrue interest at a fixed rate of 8.25% and will be repaid with four equal quarterly principal payments beginning in 2030. The facility includes customary prepayment provisions, including applicable premiums and make-whole amounts. We believe this refinancing enhances our financial flexibility and provides additional nondilutive capital to support continued investment in the Ziptori launch, life cycle management initiatives, and advancement of our pipeline, while maintaining a disciplined approach to capital allocation. Finally, turning to guidance, we are providing 2026 guidance for Jelmyto net product revenue and total company operating expenses. Given that ZESTORIA remains in the early stages of its launch, we are not providing formal sales guidance for 2026 at this time. For the full year 2026, net product revenues for Jelmyto are expected to be in the range of $97,000,000 to $101,000,000. This implies a year-over-year growth rate of approximately 3% to 7% over 2025. Full-year 2026 operating expenses are expected to be in the range of $240,000,000 to $250,000,000, including noncash share-based compensation expense of $20,000,000 to $24,000,000. The anticipated year-over-year increase in company operating expenses is primarily driven by three factors: an increase in noncash share-based compensation expense attributable to a higher stock price at the 2026 grant date and an overall increase in employee grants; the annualization of costs associated with our salesforce expansion following the Story approval in 2025; and our life cycle management plans for UGN-103. That concludes our prepared remarks. We will now open up the call to questions. Operator?

Please press 11 on your telephone and wait for your name to be announced. To withdraw your question, please press 11 again. Our first question comes from Kelsey Goodwin with Piper Sandler.

Hey, good morning, and thanks for taking our questions, and congrats on the quarter. Maybe first, I know you are not providing anything on the enrollment forms, but do you have any color or commentary you can provide there and maybe a way we could benchmark it to what you are seeing with Jelmyto, what you saw in their launch? And then in terms of the potential guidance for Zostery, I guess, when might you be able to provide that, or would that be maybe a 2027 thing? Thank you.

Yeah, I will ask Chris to answer this second question, and then and then David can answer the first question.

So, Kelsey, thanks for the question. You know, it is early in the launch, as we said. And there are certain variables that can affect the near-term uptake. So, you know, once we get a better visibility to steady-state demand, I would say at least two quarters post the permanent J code, then we could consider providing formal guidance for Zastore.

David, I will pass.

Yeah. Hi, Kelsey. It is David. With regard to patient enrollments, as expected, since the permanent J code became effective at the beginning of the year, we are seeing step up in a number of key indicators, so PEFs being one of them, and that is really in large part due to the fact that we have new writers as well as growing repeat writers. Thanks for the question.

Hey, Kelsey. Just to put a little bit of a finer point on that, to your point about how is it doing versus Jelmyto, I will tell you that, you know, and cautiously tell you because I— that all of our indicators in the month of February surpassed Jelmyto. So if you think about patient enrollment forms, you think about new patient starts and doses, we are now tracking ahead of where Jelmyto is. So take that into consideration when you think about the number for the year that we have said we are— with where our guidance is. And if you think about it versus where Jelmyto is, I think that will show you that we are on track for, you know, to hit that number. So just want to— that that is a little bit more color. I know everybody is wanting specific numbers, but I think that is the best we are going to be able to do. But I think that should give everybody confidence in kind of where we are right now.

That is great. Thank you so much.

Our next question comes from Raghuram Selvaraju with H.C. Wainwright.

Thanks so much for taking my questions and congratulations on all the progress this quarter. I just wanted to drill down on the prescribers and repeat prescribers for a second. So two questions here. Firstly, among the repeat prescribers, can you comment on the trend in this number and if you are seeing it steadily ticking up month over month, quarter over quarter? Secondly, with respect to those prescribers who have deployed Zesturi, but are not yet repeat prescribers, have you received any feedback from this group indicating how likely they would be to become repeat prescribers? And are there any specific considerations that are emerging that would prevent them from becoming repeat prescribers?

Yeah. David?

Hi there. Thanks for the question. In terms of repeat prescribers, we are seeing steady growth in— I will just comment, in both new and repeat prescribers. So to your point around repeat prescribers, what we see with them is that once they have a very positive experience with a patient, and the workflow becomes incorporated into their practice, and they have the confidence around reimbursement, which is now reinforced with the effectiveness of a permanent J code, that is really what enables them to become repeat prescribers. With many of the new prescribers, what they are really waiting to see is they typically want to make sure that they have a claim submission and they get reimbursed. And as their practices become more familiar with the medicine, implementing it in their workflows, they are very likely to become repeat prescribers. And so what we have heard from the prescriber base is that it is a steady growth in— as they become more familiar, they tackle more patients.

Very helpful. And then just quickly on life cycle management, I was wondering if you have a sense, assuming timely submission of UGN-103, approximately when you might potentially be in position to introduce it into the market in the United States? And secondly, if you could comment at all at this juncture on what you expect the dynamics to be between UGN-103 and Zasturi, and how you are thinking about 103 relative to Zasturi from a commercial positioning standpoint. Thank you.

Yeah. So the plan would be to not introduce it into the market until after we get a permanent J code. So what— what, you know, we have discussed is that we would file this year, you will get approval in 2027, and so then it would likely be 2028 when we would be in a position to launch it. And what we would do is the goal would be to transition to UGM-103 as quickly as possible, but I— you know, because there is going to be a lot of confusion, so we have to make sure that we handle that very quickly to avoid any of that. And then at the point in time where we feel confident we are not going to lose, you know, physicians and patients with Zosturi, that they will switch to 103, then we will make that switch. So we have a— we will be very purposeful, purposeful about that, and then pull Zosturi as quickly as possible. So there will not be a lot of the— to your point, the dynamic of 103 and Zasturi being on the market at the same time. That will happen, obviously. There will be a transition period. But we want to make that transition period as quick as possible.

Thank you.

Our next question comes from Michael Schmidt with Guggenheim.

Hey, good morning. Thanks for taking my questions. On ZOZURI, could you just provide some more comment on current views, especially as we think about what types of patients are leveraging the Story at this point in time? What percentage of patients are, you know, considered unfit for TURBT surgery as opposed to those that are fit and are just seeking an alternative to surgery? And how do you expect that use pattern to shift over the rest of this year? So that is question number one. Then question number two, I think you did mention some potential life cycle management opportunities, especially for UGN-103, including evaluation as an adjuvant therapy. And I am just curious, based on your market research, how well does the concept of adjuvant therapy in general resonate with patients as opposed to just using therapy as a replacement of surgery, you know, instead of as an add-on? How do you think about that? Thank you so much.

Yeah. Sure. David can answer the first, and then Mark, please be prepared to answer the question around life cycle management.

Hey, Michael. This is David. In terms of your question, I think the first thing I will say is that physician customers have been very enthusiastic about the compelling data surrounding Zasturi. We have talked about— and as we have gained more experience in the market, that complete response and durability of response really does resonate, and they do see it as a paradigm change. In terms of the patient types that they are giving Zasturi, while not a precise science, I will say they are using as we expected. So the first would be people who recur early, second would be those who have frequent recurrences, and third, those who they feel just should not go through another surgery. So we are hearing patients across the board, and that is what gives us a lot of confidence that the value proposition is getting across to them. That is supported by the fact that we have a permanent J code now in 2026. It has opened up utilization, as we discussed, in more community practices, and it is really consistent with how we thought about the launch at this point in time.

Michael, thanks. And with respect to the life cycle management question, the expansion of the use of 103 in the adjuvant setting would have to be in the setting of treating patients where we currently believe TURBT would be obligatory. So that would be in patients with a new diagnosis where a patient would— a transurethral resection to make a diagnosis, likely for new-onset intermediate-risk disease as well as new-onset high-grade disease, primary therapy would not be the standard of care but adjuvant therapy would. So we think there would be enthusiasm for it in both settings, and it would expand markedly the opportunities for patients to take advantage of the benefits of 103 in both settings. So adjuvant for new diagnosis intermediate-risk disease, as well as adjuvant therapy for patients with high-risk disease.

Great. Thanks so much. Yeah. And— and just to answer the— you know, add a little bit more color on the patient dynamics, that, you know, from the adjuvant— of how that is being used today, we do not really know. Obviously, we do not track that. We do know some physicians today are using it in the adjuvant setting for the recurrence, but we do not promote that, right? Because our data is clearly without surgery. And I think that that is very important because the idea of not having to go through surgery— while physicians may not love that idea, some of them— patients really do. And the reality of it is that the 80% complete response and the durability that we have shown— keep in mind that that is without surgery. And so we do want to— while we do recognize that some physicians may be less comfortable and they will do it in the adjuvant setting even today, we do want ultimately for them to use it without surgery because we think that is in the best interest of the patient, frankly. And we think that that also differentiates us versus all of our competitors. So anybody coming in, you know, as they are coming in, they are in the adjuvant setting, and right now, we are the only ones that are showing it as a primary. And I think that that is going to be really important as we go forward.

Our next question comes from Leland Gershell with Oppenheimer.

Good morning, and I am glad to hear the update. Thanks for taking our questions. We have two— one just on the commercial side with Astoria. As you develop that market, wanted to ask what you are seeing in terms of the community versus academic centers that are— that are kind of buying into it. Is it different than how Jelmyto proceeded in its early launch?

Yeah. Hey, Leland. Your question around channel mix, it is a little bit different. I think as you saw with Jelmyto, it was very heavily concentrated with hospitals, particularly in the beginning. What we saw in 2025 with Zasturi is that we saw about 60% utilization in a hospital-type setting. And obviously, with the effectiveness of a permanent J code, we expected that that would actually bring on more community users. And since the beginning of the year, we have started to see that happen. And as we sit here at February, I can tell you that the mix of settings has started to pivot toward the community settings. So we are looking at about 50/50 right now for Zasturi. And we do continue to— we would expect to see is that as these community settings come on board, they get experience with using the product, filing claims, and getting reimbursed, we will continue to see continued growth in the community setting over time.

Okay. Great. And then development question. You had mentioned you are looking at Zystri in the adjuvant setting in high risk. Just wondering if you could share more detail on that and perhaps other expansion opportunities in high risk? Would you be— could you be looking at the Story in combination with others? And then the adjuvant setting, would that be in BCG naïve with TURBTs, or would there be an opportunity in BCG unresponsive? Just curious if you can share any more detail there. Thank you.

Yeah. Thank you, Leland. So I think there are a lot of opportunities in high-risk disease. One area we are particularly interested in is in the BCG-unresponsive papillary high-grade disease, where we think there is a real opportunity. So we are in the process of finalizing a protocol to launch an adjuvant trial at high-risk disease, and, obviously, we will be happy to share details when that protocol is finalized. But we do think that Zosturi all by itself— or in this case, it would be 103— as a single agent would be very useful for this particular population, and that is where we would start our investigation. Liz may want to comment further on possibility of combining with other agents, however.

Yeah. I mean, I think we have definitely considered that. But it would be good— we definitely want to see how we do with just monotherapy, you know, post TURVT. But absolutely open to and have been looking at potential combinations. So we will do that as well. I mean, it makes sense for us to be in multiple areas, multiple patient populations. And so our ability to quickly launch these incremental clinical studies and broaden the patient utilization is a core strategy for us. And that is how we will ensure long-term, sustainable growth, by really being able to hit all of the patient populations in non–muscle invasive bladder cancer. There is no reason why it should not work across the board, and that is our intention.

Thank you. Very helpful.

Our next question comes from Paul Choi with Goldman Sachs.

Hi, good morning, and thank you for taking our questions. My first question is, Liz, can you maybe offer a framework about how you are thinking about the level of investment in promoting the Zasturi launch given that you eventually plan to transition to UGN-103 in the future? And just sort of what level of investment is needed here to generate a positive return on all the investment you are putting into the product currently and in the past? And then my second question is, I think in the past, you have indicated that you thought you had enough capital to sustain yourself to profitability. And so I guess how are you thinking about prioritizing capital allocation with this new loan on the forward here? And do you feel like, you know, now your— your is finally where you need it to be to get to profitability? Thank you for taking our questions.

Sure. I will answer the first, and then I will ask Chris to talk about the longer-term sustainability of the financials and our investment. And, you know, I think that where we are with investing in Zasturi versus 103, we are investing in Zasturi like 103 does not exist. I mean, we are doing everything we can to ensure the maximum opportunity and we will continue to do that. And, you know, I will give you an example. We just had a new person join the commercial team that was— in a couple of weeks— that, hey, what is one thing that I have really appreciated, and that is we have the resources. So we have resourced this launch like it needs to be, and there is nothing— no stone that we are leaving unturned, including, you know, engaging in patients. So while we are not doing broad-based DTC, we clearly are trying to reach patients in a more targeted manner. So I would say, again, absolutely fulfilling every aspect of the launch. So we are not looking at it as this is just temporary and in 2028 we are going to have 1— we are not looking at it like that. We are looking at it because what we build for Zasturi will be the foundation for UGN-103. So we are going after it correctly and, again, not leaving any stone— you know, in time for that commercial opportunity. So I feel really good about where we are from that standpoint, and we will continue to do that. And I will just ask Chris to comment on the expenses and where we are going from—

Yeah. And thanks, Paul, for the question. So, you know, as we said before, the path to profitability is really tied to the Story launch and the uptake, and we are on track there. You know, the purpose of the refinance really accomplished two things for us. One, meaningfully reduced our cost of capital— so the prior loan had a, you know, seven and a half percent plus three-month SOFR variable rate, so call it 12% interest rate— and we reduced that now down to 8.25%. And then two, it gave us financial flexibility. So one, extended the repayment period— you know, it was going to start second quarter next year, now starts 2030— and did bring in additional nondilutive capital to further build out the balance sheet. But to be clear, we will remain disciplined in our approach to capital allocation, balancing path to profitability and then also making sure that we are investing in the long-term growth strategy.

And I will just add that the addition of the $50,000,000 or $75,000,000 does not change what we have said before around path to profitability, right? It gives us some cushion and gives us more flexibility, but it does not— we are not— we did not do that because we needed, you know, that money to get to profitability. But it definitely gives us flexibility. So just to be really clear, we have not changed our commentary around path to profitability.

This time, please press 11 on your touch tone phone. Our next question comes from Aydin Huseynov with Ladenburg.

Hi, good morning. Thanks for taking our questions. I have a couple, one on Zasturi, one on UGN-501. For Zasturi, I appreciate confirming the long-term guidance for Zasturi. So I just wanted to better understand, maybe if you could provide some color in terms of when do you think this peak sales would occur. Is it 2035, 2040? And what would happen after you reach those peak sales? And for UGN-501, the question is, I just wanted to better understand the RTGel technology and how that would help UGN-501 oncolytic virus to be differentiated from other oncolytic viruses, and whether you would need a primer to activate the virus. Thank you so much.

Yeah. Thanks, Chris. I will ask Chris to answer the first question, and then we can turn over to Mark to answer around 05:01. Okay, and thanks. So, let me pass the—

Peak or time to peak, you know, I would assume roughly four years to peak. So now that we have the J code, a four-year ramp to peak is reasonable.

And, Mark, you want to just talk about 05/2001 with and without the gel?

Sure. Thank you. So, as you— as many who are listening know, our current plan to launch a Phase 1 study in 05/2001, which we will do this year in high-grade disease, is an aqueous-based preparation that is preceded by the use of an activating agent that you were alluding to, DDM. We are in the process of studying how long dwell time or longer dwell time could potentiate the efficacy of the virus in the setting in which we will initially explore its use, which is obviously intravesical therapy for bladder cancer. So we are in the process of doing that currently. Theoretically— and, again, this is speculation currently, but we are looking into this right now— we believe there may be an advantage to a longer dwell time, which may obviate the need for additional interventions prior to introduction of the virus. But that is currently under investigation, and we will obviously share details when we have more to share.

Thank you. Thanks so much. Very helpful. Thank you.

That concludes today's question-and-answer session. I would like to turn the call back to Elizabeth A. Barrett for closing remarks.

So just want to say thank you to everybody for the support. As you heard today, very excited about how things are going with the launch. You know, we gave information that hopefully gives you the confidence that, you know, where we are, we are starting out the year very strong. So we obviously will look forward to sharing all of the information from Q1 and the Q1 earnings. But suffice it to say that we are excited about where we are. We think we are in a great position to hit our goals and hit all of the milestones that we expected on the Story, which Jelmyto is doing well as well. And then want to focus the back half of the year around expansion into other areas. So I think from a company perspective, we feel like we are in a great position. We are in a great financial position. Things are going really well with the launch. We are executing against our pipeline, and so that we actually are in a position where we see the future being a long-term sustainable growth and being able to do that. So, again, thank you everybody for hanging in there for all these years. We are finally, I think, at a place where we have all been working toward, and appreciate the support. So we will be keeping everybody up to date. Look forward to seeing some of you at the conference tomorrow. So thanks a lot. You can disconnect now, operator.

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