UroGen Pharma (NASDAQ:URGN) reported first-quarter financial results on Wednesday. The transcript from the company's first-quarter earnings call has been provided below.

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Summary

UroGen Pharma reported $29.2 million in Zasturi revenue for Q1 2026, marking over 100% quarter-over-quarter growth due to the successful implementation of the permanent J Code.

The company is focused on expanding Zasturi adoption, particularly in community practices, aiming for a balance between hospital and community utilization.

UroGen Pharma expects continued strong growth in 2026, driven by expanded healthcare provider engagement and patient awareness efforts.

Jalmito generated $21.7 million in Q1, with anticipated full-year sales between $97 million to $101 million.

The company's pipeline includes UGN103 with an NDA submission planned for the second half of 2026 and potential approval in 2027.

UroGen Pharma maintains a strong balance sheet with approximately $140 million in cash, cash equivalents, and marketable securities.

Management highlighted the strategic importance of reducing time from patient enrollment forms to treatment initiation, aiming to achieve a 2-3 week timeframe.

The company sees significant market potential for Zasturi as a non-surgical treatment in bladder cancer, targeting a $5 billion annual market opportunity.

Full Transcript

OPERATOR

Good day and thank you for standing by. Welcome to UroGen Pharma Q1 2026 results earning 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 11 on your telephone. You will then hear an automated message advising your hand is raised to withdraw your question. Please press star 11 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.

Vincent Perrone (Senior Director of Investor Relations)

Thank you. Good morning everyone and welcome to UroGen Pharma's first 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@investors.eurogen.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 Zysduri 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 Zysduri's growth for Urogen's long term strategy, the potential benefits of our products and product candidates, future R and 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 Pharma disclaims any obligation to update these statements. I'll now turn the call over to Liz.

Liz Barrett (President and Chief Executive Officer)

Thanks Vincent. Good morning and thank you for joining us today. Before I provide our business update, I wanted to share that given the critical importance of a successful Zysduri 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 Zysduri 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 and 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 values the story 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, zesturi offers a non surgical treatment in a disease historically managed through repeated surgical intervention. Zysduri'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 Zysduri 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 (Patient Enrollment Forms) 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 PEP volume and which we believe reflects strong and expanded healthcare provider engagement as we've shared PEFs, new patient starts and doses all significantly outpaced Jalmido 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 to 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 two to three 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 5050 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 Zysduri. 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 Duri becoming effective on January 1, 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 ASTRU 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 Zysduria is in a unique position of providing both recurrence and treatment. Free living Zysduria addresses an estimated $5 billion annual market opportunity and 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 Zysduri 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 to 101 million. We continue to advance our pipeline including UGM 103, our next generation mitomycin based intravascular 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 URO oncology 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, cash equivalents and marketable securities as of March 31, supported by the refinancing of our term loan with Pharmaicon Advisors during the quarter. This provides us with the flexibility to fully support the ongoing launch of SSTURI 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 Schoenberg

Mark thank you Liz. The American Urologic Association Annual Meeting will take place May 15th to 18th in Washington, DC. 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 Zysduri and Gelmyta. 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 zosturia 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. Zysduri was specifically designed to address this need. Its clinical benefit is driven by both its efficacy and mode of administration. In the Phase 3 ENVISION trial, which supported its FDA approval, Zysduri demonstrated a robust complete response rate of approximately 80% at three 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 would be featured in a PODIUM presentation at the upcoming AUA Congress. Importantly, median duration of response has not been reached in the envisioned study at a median follow up of 23.7 months after 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 Zysduri is delivered. It is administered as a finite six 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 one year. Zysduria, by contrast, is designed as a primary non surgical therapy with a total treatment duration of six 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 Zysduri, 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 Zysduri is being incorporated into routine practice. Turning now to the pipeline, UGN103 is our next generation mitamycin based formulation for recurrent low grade intermediate risk non muscle invasive bladder cancer. Developed to build on the foundation established by Zysduri, 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 3 Utopia trial which demonstrated a 77.8% complete response rate at three months consistent with what we observed with Zysduria. We are aligned with the FDA that the NDA can be submitted with 6 months 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 UGN103 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 three trial in high grade disease before year end and in the adjuvant intermediate risk setting thereafter. EGN104, our next generation program for low grade upper tract urothelial cancer, continues to progress in a phase three trial as planned with enrollment expected to complete by the end of 2026. Finally, UGN501 is our investigational next generation oncolytic virus therapy being developed as a locally administered treatment for cancer. UGN501 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 UGN501 from other oncolytic viruses in development. IND enabling studies are nearing completion and we plan to submit an IND in the second quarter of 2026 and initiate a phase 1 clinical trial in NMIBC by year end. Our non clinical data support the potential for UGN501 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 UGM501 has the potential to be best in class highly active, locally delivered therapeutic approach in this setting. The phase 1 trial will initially evaluate UGN501 via aqueous intravesical administration. In parallel, we plan to explore additional modes of delivery including administration with our proprietary RT gel 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.

Chris Degnan (Chief Financial Officer)

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 Zostori, 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 launches of Zysduri 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 and D expenses was primarily attributable to the acquisition of UGN501 in the first quarter of 2025. Zysduri manufacturing costs, which we recognized as R and 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 SGA expenses was primarily attributable to Zestori commercial activities including the Salesforce expansion following Zysduri approval and higher brand marketing expenses, an increase in overall commercial operation costs and higher advisory costs including fees associated with the Pharmakon Advisors debt refinancing. We expect Q1 to be the high point of SG and 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 & Co. 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 pharmacon 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 and the quarter ended March 31, 2026 compare 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, 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 to 101 million dollars. This implies a year over year growth rate of approximately 3 to 7% over 2025. We are not providing formal sales guidance for Zosturia 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 to 250 million dollars, including non cash share based compensation expense of 20 to 24 million dollars. That concludes our prepared remarks. We will now open the call to questions.

OPERATOR

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 11 again. Please stand by while we compile the Q and A roster. Our first question comes from Tara Bancroft from TD Cohen. Tara, the line is open.

Tara Bancroft (Equity Analyst)

Hi, good morning. So congrats on the great quarter. Love to see it. And you know, with this quarter, it appears that you'll pretty significantly exceed the Anktiva (an analogous product) demand driven growth that you previously pointed to as a solid analog for, you know, those six months post the permanent J code. So I'm wondering if you have any updated thoughts on how we should think about growth for the rest of the year from here and maybe is there any other analog that we should look to instead from here.

Chris Degnan (Chief Financial Officer)

Hi Tara. Thank you. I'm going to 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 Aniva just to re ground folks. When we looked at the first six months with the permanent J code, you know, they saw a 220% step up in their revenue. And 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. But I mean I think it's important for reiterate a few points from the call. One, that we're seeing consistent growth across all our commercial indicators. This wasn't a one time step up with the J code that we saw in January. So these trends that we're seeing are progressing consistently throughout the quarter and into Q2, which gives us confidence that the underlying demand is building in a sustainable way. And as Liz mentioned on the call, we do expect continued growth in Q2 and throughout the year given the early stages of the launch.

Liz Barrett (President and Chief Executive Officer)

Yeah, so unfortunately we don't have a great analog, to be honest with you, that we could share with you. I think as Chris stated, I think we feel good about where we are. We expect to Continue to grow. We do want to caution everybody that quarter over quarter growth is not likely to be the same as we go forward as it was in the Q1 versus Q4 because of the J code dynamics. But we do expect to continue to see quarter over quarter growth. So 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 and. But right now we're just not in a good position to provide any additional guidance beyond that.

Tara Bancroft (Equity Analyst)

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

Liz Barrett (President and Chief Executive Officer)

Thanks. Appreciate it.

OPERATOR

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

Kelsey Goodwin (Equity Analyst)

Oh, perfect. Hey, thanks so much for taking our questions and congrats on the really strong quarter. That's wonderful. Liz, two questions from us. First, could you provide more color on how many TURBTs these patients are receiving prior to getting zusturi? What kind of patients are getting zesturi now? And when patients recur, how do you get Zysduri to kind of be that first product that physicians reach for? And then secondly, on reimbursement, now that physicians are getting more comfortable post permanent J code, I guess maybe could you provide some color on what kind of cost sensitivity you're seeing given Zysduri's priced, you know, relatively lower than some of the high risk programs at about 130k price range. Thanks so much.

Liz Barrett (President and Chief Executive Officer)

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 two or three TURBTs. Having said that, we do have physicians that have already adopted Zysduri as sort of their standard of care. And so for a recurrent patient, and what I mean by that is they're looking, you know, we do have, you know, physicians who have treated several patients, you know, into the high teens. And so they are really adopting it across the entire paradigm of patients. So I think we will get there and we want to be very careful. And that's one of the things we also are very careful with our sales team is that we don't niche ourselves into those that have had multiple TURBTs. Keeping in mind that 23% have had five or more and 68% have had two or more. So Even if we did have those patients, there's still a large number of patients. But we want to make sure that everybody understands. And particularly if you look at our clinical study, a lot of those patients only had one or two. And so we are seeing again, but 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. So 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 and so it's hard to. But we do get lumped in. Unfortunately, when they talk about high priced drugs, they are lumping us in there. So we have to continuously remind everybody to your point that our price is significantly less. And we also want to bring that awareness as those high priced drugs start to move into the low grade space. When we developed our pricing, it was specifically for the low grade patient. And also take into consideration the duration of therapy because one of the reasons that ours is $130,000 is because you only have six 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. So you're talking about six doses versus 14 plus doses. That also increases the price. So we hope that 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.

Kelsey Goodwin (Equity Analyst)

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

Liz Barrett (President and Chief Executive Officer)

Thanks. Appreciate it.

OPERATOR

Kelsey, thank you. One moment for our next question. Our next question comes from Amin Makarim from Jeffries. 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 and whether you're seeing any acceleration early in this quarter

Amin Makarim (Equity Analyst)

and the second one within the new prescribers. How does the mix break down between community versus academics and are you seeing a meaningful differences in demand across these groups already early in this launch?

Chris Degnan (Chief Financial Officer)

Yeah. Chris, you want to comment and then I'll. Sure. I mean, thanks for the question. So 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. And I would say that trend continues in the early stages of Q2. And in terms of mix, as Liz mentioned on the call, 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. And so that is a big part of our growth and we expect that to continue to shift more and more towards the community practices throughout the course of the year. And just a reminder, 65, 70% of these patients are treated in the community setting. So that's a big piece with the JCO being in place and opening up those practices for us.

Liz Barrett (President and Chief Executive Officer)

Yeah, I think it's also just important to note 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. So we have some large academic centers that we just received in the last month, the formulary, positive formulary, just so you'll see some new academic centers coming on board as well. So it's a continuous thing. But obviously most of those patients, low grade patients, do get treated in the community. So as we grow community, but also important that we also support the institutions as they are big drivers also of the adoption. But thanks for your questions.

OPERATOR

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

Michael Schmidt (Equity Analyst)

Hey guys, good morning. Thanks for taking my question and congrats on a great first quarter. Yeah, maybe just another follow up on cisduri. Could you just comment if you're seeing a change perhaps in the type of patients that are choosing cisduri now over turbt. I think initially you spoke about preference by patients who are high risk surgery, high risk or elderly type patients. I'm just curious if that's shifting a bit now that the prostitution been on the market longer and then 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 your BT and how could that impact the landscape as you think about story use long term? Thank you.

Liz Barrett (President and Chief Executive Officer)

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 being able to get Zysduri. I think in your comment about that I will also say also answers part of your second question. What we are finding and what we're hearing and this is so I just want to be very careful about that is we are starting to see and hear about patients requesting the stirring. We're hearing things like, oh, I want that gel stuff. And so 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. And so when you talk to patients, they don't want another surgery. So while at the adjuvant setting, I believe that you'll always have those physicians who want to do surgery because it's in their nature to cut it out and then come back with another therapy. I think you're going to see that patients are going to be opposed to that and patients are going to want to say, hey, let me see how this one works without surgery, because you can 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 a stiri and she did have two small lesions which were able to be fulgrated in the office. So 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 physicians that are even using Zosturi right now after surgery. But 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. So it's a clear differentiator for us. And given the results, you have to look at the complete response and the durability that we have without surgery. So to your point, I think it will continue to evolve. I think there will be opportunity for others in this space. I think more companies and more drugs being introduced will help to grow the market. And as we've talked about before, even given the pricing of our medicine and the use of only six weekly doses, we still believe that we'll have over a billion dollar revenue drug with only less than a 20% market penetration. So I 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. And especially even today, there's no one coming in in the near future. So it's going to be a couple years before there's others coming in. But our ability to offer patients an opportunity to not go through surgery but still get Very meaningful results is very critical.

OPERATOR

Thank you. One moment for our next question. Our next question comes from the line of Roguram Selvuraju from HC Wainwright and co.

Roguram Selvuraju (Equity Analyst)

Thanks so much for taking our questions. Just three 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 Zasturi to be by the end of 2026, 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 Zasturi revenue base, just on a percentage 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. And then lastly, I was wondering if you could just provide us with a few words on Gelmido and what you see as the long term future for that product as well as the lifecycle management initiative with 104. Can we expect some reacceleration of Gel Mito uptake? Do you think that there is some incremental gain to be made on that front with that product? And perhaps most importantly, are you seeing some renewed interest in Gel Mito given the receptivity you've seen so far with Zosturi among prescribing physicians? Thank you.

Liz Barrett (President and Chief Executive Officer)

Yeah, I'm going to 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 Jaumito. We expect, as I mentioned in the remarks, to continue to see this sort of predictable growth where we are. So we will continue to see low single digit growth. That's what we've been talking about. The good news is that we do continue to see new users of Jelmyto. The issue for Jammido always comes around finding the patients. So as we go out and talk about Zosturi, even before Zosturi may be on formulary, they're hearing about Jelmyto. We're getting new users using Jelmyto. So every quarter we have new physicians using Jelmyto. So we expect that to continue. And again, the challenge there is really where the patient presents. So you may have a doctor this quarter and that doctor won't see another jalmido patient for 2, 3, 4 quarters and so a lot of that. So 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 Zasturi will help that. And we've talked about that before with UGN104 coming in. It will be interesting to see the data with UGN104. And 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 required that we characterize that. We had some physicians who see that and get a little bit worried about that. But now that the nephrostomy tube is at least half of the usage and the clinical study, we'll have to see how that comes out in the clinical study. And also given the long term durability of Jelmyto and we're seeing very similar results with Zosturi. I think all of those things point to our ability to continue to grow the low single digits for Jelmyto and the fact that we'll continue to grow the number of doctors that we're calling on with Sisteri and that will also help Jamito on the community versus the hospital where we end up, my guess is going to be more of a 6040 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 treated multiple times, they tend to be sent to an institution, academic institution and we also know that they tend to be high volume accounts. And so while we expect ultimately the community bigger, the institutions will always be a major part of the story. And we have some, some institution physicians who have already become real champions and advocates of Zosturi and as I mentioned before, using it on most of their patients. And they're seeing, and I'm sure you heard last week with Dr. Chamy, he's seeing more patients than he frankly thought he would that are appropriate for Zasturi. And I think we're hearing that more and more. So I think that's where we'll end up in the Then 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 Degnan (Chief Financial Officer)

So Chris. Thanks Rahm. So from PEF to new patient start as we talked about last year was roughly 45 to 60 days and a lot of that less. So the benefit verification which only takes a few days once it's submitted to the hub, it was more the operational pieces and also as more use was in the hospital last year just getting on hospital formulary. So we do expect as this gets adopted into clinical workflows, that our time to conversion is going to compress. And we did see that already in Q1. So average time to conversion in Q1 was 30 to 35 days. So we're starting to see that walk down and we expect ultimately in steady state to be closer to where we are today for gel mito, which is two to three weeks from PEP to new patient start.

Roguram Selvuraju (Equity Analyst)

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

Liz Barrett (President and Chief Executive Officer)

Thanks, Ram.

OPERATOR

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

Paul Choi (Equity Analyst)

Thank you. Thanks for taking our questions and let me add my congratulations on the good results. Liz, I was wondering if you could maybe provide some color on where the Zusturi update is happening. Specifically, what is the sort of percentage of overlap with existing gel mito users versus prescribers who are just new and outside your current commercial base or prior commercial base? And my second question from Mark is I was wondering if you could expand a little bit more on UGN103 development plans and potentially an adjuvant trial that seems to be the direction of travel for some of your competitors and, and just what that kind of trial in your mind might look like for UGN103. Thank you.

Liz Barrett (President and Chief Executive Officer)

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

Mark Schoenberg

Yeah, sure. Thanks, Liz. Thank you, Paul. So, yes, we are excited about UGN103's NDA submission this year and expected approval for the successor molecule for Zysturi 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. And 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.

Liz Barrett (President and Chief Executive Officer)

Yeah, I think the only additional comment I'll make about that is 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, because some physicians want to, it's probably in our best interest to at least generate some data of using Zosturi in the adjuvant setting. So it's one of the reasons we're doing what Mark was talking about. To go to your first question around Jalmido overlap. Absolutely. And some of our initial users were our Jalmido users. And we see today over 50% of the Zosturi users are Jalmido users. That's not surprising, Obviously, because the 95% of Jamaido users are as a stirre, you know, potential as a story. It doesn't. The flip side is not necessarily the case given the rare nature of the upper tract urothelial carcinoma. But so we're seeing again now. In the beginning, I would say it was even higher. We started out some of our initial users were Jalmido users, so probably 80%, but now it's a little over 50%. So we're seeing both the Jammido and non Jamido users using Zosturi. So I hope that helps, Paul?

Paul Choi (Equity Analyst)

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

Liz Barrett (President and Chief Executive Officer)

Thank you.

OPERATOR

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

Leland Gershel (Equity Analyst)

Great. Thanks for taking our questions and terrific to see Zesturi 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 rollout plan with respect to goals of those various metrics. Thanks very much.

Liz Barrett (President and Chief Executive Officer)

Thanks, Leland, and thanks for the support. Very, very early. So we're nowhere near where we want to be. We have a target of 8,500 doctors, healthcare providers, and as we talked about today, we've only got 300 unique prescribers. So we have a long way to go. But I think that's great news. 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. And part of our, 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. But, you know, absolutely, we have a long way to go. So we're just in the very, very early stages of where we want to be with penetration among docs. So long way to go. Very, very early. In the early stages.

Leland Gershel (Equity Analyst)

Great. Thanks very much.

Liz Barrett (President and Chief Executive Officer)

Thanks, Leland.

OPERATOR

Thank you. I am showing no further questions. This concludes the question session. I would now like to turn it back to Liz Barrett for closing remarks.

Liz Barrett (President and Chief Executive Officer)

Thanks. I'm 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. So thanks for all the support. Happy to continue to share progress as we get into Q2 and beyond. So thanks again for everybody's support, and we will talk to you guys soon. You can disconnect now. Operator.

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