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UroGen Pharma - Earnings Call - Q2 2025

August 7, 2025

Executive Summary

  • Q2 delivered a clean top-line beat and bottom-line miss: revenue was $24.22M vs. S&P Global consensus $23.13M, while EPS was ($1.05) vs. ($0.83) consensus; the miss was driven by higher SG&A tied to the ZUSDURI launch and elevated R&D, including UGN‑103 costs. Revenue Consensus and EPS Consensus from S&P Global marked with “*” below. Values retrieved from S&P Global.
  • FDA approval and launch of ZUSDURI (UGN‑102) transforms UroGen into a multi‑product uro‑oncology company; management emphasized strong physician interest but reiterated that reimbursement frictions (miscellaneous J‑code) will constrain near‑term velocity until a permanent J‑code expected January 1, 2026.
  • JELMYTO net product sales grew 11% YoY to $24.2M, supported by 7% underlying demand growth and price favorability; FY25 JELMYTO sales guidance ($94–$98M) and OpEx guidance ($215–$225M) were maintained, framing a disciplined but investment‑heavy launch year.
  • Balance sheet remains solid to fund the launch and pipeline: cash, cash equivalents and marketable securities were $161.6M at quarter‑end; management highlighted ~84% payer coverage for ZUSDURI already, a positive early‑launch signal.
  • Near‑term stock catalysts: traction metrics post‑launch (sites activated, first paid claims), progress on payer coverage/formularies, and clarity on ZUSDURI adoption ramp vs. J‑code timing; medium‑term catalysts include initial UGN‑103 readouts and continued durability updates for ZUSDURI.

What Went Well and What Went Wrong

  • What Went Well

    • ZUSDURI FDA approval and commercial launch; CEO: “truly transformative milestone…marking our evolution into a multi‑product uro‑oncology company”.
    • JELMYTO performance: $24.2M in Q2 (+11% YoY), with 7% demand growth; gross‑to‑net has stabilized, supporting revenue quality.
    • Early launch infrastructure strong: sales force expanded to 82 territories, ~84% payer coverage already, and an initial focus on ~2,000 likely early adopters to overcome miscellaneous J‑code frictions.

  • What Went Wrong

    • Profitability pressure intensified: net loss widened to ($49.9M) vs. ($33.4M) YoY; EPS ($1.05) missed consensus as SG&A stepped up for the ZUSDURI launch and R&D rose with UGN‑103 manufacturing and trial costs.
    • Reimbursement friction near‑term: management declined to provide early script/paid‑claim metrics and underscored that the biggest hurdle is reimbursement until a permanent J‑code arrives in Jan‑26, delaying broader community uptake.
    • Higher financing/interest burden: interest expense rose to $4.1M (term loan) and prepaid forward obligation expense was $4.6M; OpEx remains elevated with ~$15M in non‑recurring costs during Q2 (ODAC/launch/manufacturing).
View the full earnings report

Transcript

Speaker 5

Okay, and thank you for standing by. Welcome to the UroGen Pharma second quarter 2025 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 *11 on your telephone. You will then hear an automated message advising you your hand is raised. To withdraw your question, please press *11 again. Please be advised that today's conference is being recorded. I'd now like to go ahead and hand the conference over to your first speaker today, Vincent Perrone, Investor Relations. Vincent, you have the floor.

Speaker 1

Thank you, operator. Good morning, everyone, and welcome to UroGen Pharma's second quarter 2025 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 June 30, 2025. The press release can be accessed on the Investors portion of our website at investors.urogen.com. Joining me on the call today are Liz Barrett, President and Chief Executive Officer, Dr. Mark Schoenberg, Chief Medical Officer, David Lin, Chief Commercial Officer, and Chris Degnan, Chief Financial Officer. During today's call, we will be making certain forward-looking statements.

These may include statements regarding our ongoing commercialization activities related to Jelmyto and Zesturi, our ongoing and planned clinical trials, commercial and clinical milestones, market and revenue opportunities, our commercialization strategy and expectations, as well as anticipated data, regulatory filings, and decisions, Zesturi being the primary growth driver for UroGen, the potential benefits of our product and product candidates, future R&D development efforts, our corporate goals, and 2025 financial guidance, among other things. These forward-looking statements are based on current information, assumptions, and expectations that are subject to change. A description of potential risks can be found in our earnings press release and latest SEC disclosure documents. You are cautioned not to place undue reliance on these forward-looking statements, and UroGen disclaims any obligation to update these statements. I'll now turn the call over to Liz.

Speaker 5

Thank you, Vincent. On June 12th, we achieved a defining milestone for UroGen with the FDA approval of Zesturi for adults with recurrent, low-grade, intermediate-risk non-muscle invasive bladder cancer. This was truly a landmark moment for our company, and importantly, for the 59,000 annual patients in the U.S. who face recurrence and repeat surgeries year after year with no approved alternative. Zesturi is the first and only FDA-approved pharmacologic treatment for adults with this disease and has the potential to fundamentally change the treatment paradigm and offer patients durable, long-term recurrence and treatment-free living. We are proud to be leading that shift. Zesturi is UroGen's second commercial product and marks our transition from a rare disease-focused company to a scaled multi-product organization. Five years ago, we launched Jelmyto for the treatment of low-grade upper tract urothelial cancer. That experience laid the foundation for everything we're doing today.

With Zesturi, we are entering a larger but less complex market. The total available market exceeds $5 billion annually, and we are well positioned to penetrate the opportunity with our expanded sales team of 82 territories as of August 1st, up from 50 previously. We have an experienced team with strong knowledge and relationships that will allow us to accelerate and guide the launch of Zesturi. Our commercial organization has a deep understanding of how care is delivered in urology, from academic centers to high-volume community practices. Their established relationships and field insights position us well for a strong and disciplined launch. Regarding the commercial launch of Zesturi, the initial focus is on setting up sites of care and driving clinical conviction. The team is focused on driving early adoption among urologists who previously prescribed Jelmyto and those willing to initiate treatment before a permanent J-code is assigned.

This is a disciplined, strategic launch built on learnings from our first product. As we move to 2026 with broader reimbursement anticipated, we expect our reach to expand significantly. David will provide more details on the launch in a few minutes. Turning to Jelmyto, I'm pleased to report a strong second quarter with net product revenues of $24.2 million, representing an 11% increase over the same period in 2024. Jelmyto continues to grow with strong underlying demand in the second quarter, demonstrating continued adoption and usage of this important therapy for patients. The value proposition of Jelmyto remains clear: durable responses backed by long-term data and real-world use. We are pleased with results and acceptance received by urologists. UroGen's long-term goal is to develop and commercialize a differentiated portfolio of treatments that address meaningful unmet needs across urothelial and specialty cancers.

UGN301, our anti-CTLA4 monoclonal antibody, continues to progress in both monotherapy and combination studies for high-grade non-muscle invasive bladder cancer. Meanwhile, our next-generation pipeline is advancing. The Phase III Utopia trial of UGN103 for recurrent low-grade, intermediate-risk non-muscle invasive bladder cancer is now fully enrolled, and we expect initial complete response data by the end of 2025. We will share this data with the FDA and gain agreement on the path forward to approval. If the trial is successful, we expect to file an NDA for this product in 2026. We've also initiated a Phase III trial in June of 2025 for UGN104, our next-generation mitomycin-based formulation for low-grade UTUC. Our balance sheet remains strong with $161.6 million in cash, cash equivalents, and marketable securities as of June 30th.

We believe we have the necessary capital to fund the Zesturi launch while supporting the advancement of our pipeline and other strategic priorities. We will be thoughtful about potential opportunities to expand our portfolio for the long term while driving commercial success and profitability goals. The team at UroGen has demonstrated their dedication and resilience while striving to make a meaningful impact for patients. To the urology community, particularly those participating in research, as well as those publicly advocating support for our medicine, we could not do it without you. With two commercial products, an advancing pipeline, and a commercial infrastructure to scale, UroGen is well positioned for sustainable growth. We are executing with discipline and purpose, and we remain deeply committed to delivering meaningful innovation for patients and generating value for our shareholders. I will now turn the call over to Mark Schoenberg. Mark.

Speaker 7

Thank you, Liz. As a practicing urologist, I've spent years managing patients with recurrent low-grade, intermediate-risk non-muscle invasive bladder cancer. We see the approval of Zesturi as a meaningful advancement in how we care for this population. For the first time, we can offer patients and their healthcare providers an effective pharmacologic treatment that targets the underlying disease and offers a convenient office-based outpatient alternative to repeated surgeries. We view this as a significant shift in the standard of care. Historically, transurethral resection of bladder tumor, or TURBT, has been the only real option for patients with low-grade, intermediate-risk disease. TURBT is an invasive surgical procedure. It requires general anesthesia and access to an operating room, and it carries risks, especially in an older population.

Patients are typically diagnosed with bladder cancer in their mid-70s, and many of these patients have comorbidities that make surgery under general anesthesia less than ideal. We also know this is a highly recurrent disease. Approximately 68% of patients experience at least two recurrences, and 23% will have five or more. That means multiple surgeries under general anesthesia and an ongoing burden that takes a toll on both physical health and quality of life, not to mention the burden placed on partners, family, and other caregivers. In addition, repeated TURBT procedures may be associated with an increased risk of mortality. Zesturi offers a new non-surgical treatment approach. Zesturi is administered as an intravesical instillation via urinary catheter once a week for six weeks in a physician's office. No operating room, no general anesthesia, and minimal recovery time.

In many cases, a trained nurse can perform the procedure right in the urologist's office. For patients, this means a much less disruptive experience. For medical practices, it means increased OR availability for more complex procedures and an efficient in-office option that can streamline treatment delivery. The clinical data supporting Zesturi are both robust and continuing to mature. In our ongoing pivotal Phase III Envision trial, 79% of patients achieved a complete response at three months following the completion of treatment. Equally important, however, is the durability of that response. In bladder cancer, long-term disease control is what truly improves outcomes and quality of life for patients. In our most recent update from Envision, which we shared earlier this week, we announced the 24-month duration of response of 72.2% by Kaplan-Meier estimate for patients who achieved a complete response at three months after the first instillation of Zesturi.

The sustained response observed offers real value to both patients and practices, allowing management of recurrence with greater confidence and extending the time between recurrences. Importantly, the median duration of response has not been reached, and the event rate has not accelerated and remains steady over time. According to the published literature, the median duration of response for TURBT in this population is approximately six to nine months, with a substantial proportion of patients recurring within the first year. These results are further supported by the five-year follow-up data from Phase II OPTIMA II study in both newly diagnosed and recurrent disease, which was published in the Journal of Clinical Genitourinary Cancer this past June. In that trial, of the 41 patients who achieved a complete response, the median duration of response was approximately two years by Kaplan-Meier estimate.

Among the 17 patients who entered the five-year extension study, the median duration of response was 3.5 years. These data contribute to the growing and consistent body of evidence demonstrating that Zesturi is not only effective in achieving a complete response, but also offers durable disease control over time. We are very optimistic about the emerging long-term durability profile of Zesturi. I'll now briefly update you on the clinical pipeline. UGN301 is our investigational anti-CTLA4 antibody delivered via RTGel. It is currently being evaluated in a Phase I trial, both as monotherapy and in combination with UGN201, our PLR7 agonist, and with gemcitabine. We shared the latest data at the AUA meeting in April, and the safety profile continues to be favorable across both the monotherapy and combination arms.

We observed clinical responses in both monotherapy and combination arms, with follow-up on the combination arms ongoing to evaluate the durability of response. We expect to share updated data later this year, and we'll use those results to guide a potential decision to move into Phase II development. As Liz mentioned earlier, we're also advancing our next-generation formulations of Zesturi and Jelmyto. The Phase III Utopia trial is evaluating UGN103, the successor to Zesturi, in patients with recurrent low-grade, intermediate-risk disease and has completed enrollment. This study is modeled closely on Envision. Efficacy will be measured by the complete response rate at three months, with follow-up focused on assessing durability. We expect top-line complete response data by the end of this year, and we plan to share those results with the FDA to help inform the regulatory path forward.

We are also taking a similar approach with UGN104, our next-generation formulation of Jelmyto. We recently initiated a single-arm Phase III trial, and patient screening is underway. UGN501, our recently acquired next-generation oncolytic virus candidate, is progressing through IND-enabling studies with a Phase I trial anticipated to begin next year. I will now turn the call over to David for the commercial update.

Speaker 1

Thank you, Mark. As my colleagues have shared, we believe Zesturi represents a true shift in how recurrent low-grade, intermediate-risk non-muscle invasive bladder cancer is treated. Our focus now is on ensuring that all appropriate patients have access to Zesturi in an accelerated and successful launch. We have completed the expansion of our sales force, having increased the total number of reps from 50 to 82. With this footprint, we believe we are well positioned to reach the 8,500 healthcare providers who treat approximately 90% of the addressable patient population. We view the launch in two distinct phases. The first phase covers the period from July through the end of this year. The second begins on January 1, 2026, when we expect to receive a permanent product-specific J-code.

That milestone will be an important catalyst for broadening adoption, particularly in the community setting where reimbursement logistics play a critical role in treatment decisions. During the initial phase, our commercial priorities fall into three areas: engaging with healthcare providers, activating treatment sites, and advancing market access. First, our field team is focused on building awareness, establishing clinical conviction, and ensuring providers and staff are educated on how Zesturi will benefit appropriate patients. Even at this early stage, we are encouraged by the level of interest we're seeing. Awareness around Zesturi is strong, and healthcare providers are eager to learn about the profile of Zesturi and engage on appropriate patient types. Customer questions focus on the clinical, operational, and financial considerations to begin treating with Zesturi.

We are initially focused on a group of roughly 2,000 physicians out of our total 8,500 target universe, whom we've identified as likely early adopters. These are physicians who have demonstrated a willingness to introduce new therapies during a miscellaneous J-code period. Our goal is to engage with the majority of accounts within the first six to eight weeks of launch, and we are making strong progress toward that target. Our discussions with physicians are focused on identifying patients who stand to benefit most from treatment with Zesturi. This typically involves those with multiple prior recurrences and a history of repeated TURBTs, patients experiencing early recurrences after surgery, and patients who may be poor surgical candidates due to comorbidities or other risk factors. The second area of focus is site activation. We are working closely with practices and hospitals to ensure operational readiness.

This includes everything from distributor onboarding to clinical training and pharmacy processes. As we have noted previously, many providers prefer to initiate the use of new therapies like Zesturi in the hospital outpatient setting, where hospital pharmacy budgets are often managed at separate cost centers. We are supporting this process, including working with P&T committees to ensure formulary placement as quickly as possible. On the market access front, our team is actively engaged with major payers nationwide. At this stage, we have secured open access for approximately 84% of covered lives. These efforts are central to the launch and reflect our commitment to ensuring patients can access Zesturi without unnecessary administrative or financial barriers. Looking ahead to 2026, the assignment of a permanent J-code should significantly simplify the reimbursement process.

At that point, we intend to broaden our commercial focus to include a broader segment of the urology market, including many more community-based practices. Turning to Jelmyto, we continue to drive strong year-over-year unit growth, which reflects growing comfort and conviction among urologists. We see steady growth in both the number of sites of care and the number of new prescribers, and we are encouraged by the positive trends in patient identification. The message around durability of response remains central and continues to resonate, and our team is maintaining high-frequency engagement with top-performing accounts to sustain momentum and drive further growth. I will now turn the call over to Chris Degnan for a financial update. Thank you, David. As Liz mentioned earlier, Jelmyto net product revenues were $24.2 million for the three months ended June 30, 2025, compared with $21.8 million in the same period in 2024.

Year-over-year revenue growth of 11% was driven by underlying demand growth of 7% and price favorability, as the gross-to-net rate for Jelmyto has stabilized in recent quarters. R&D expenses for the second quarter of 2025 were $18.9 million, including non-cash share-based compensation expense of $0.4 million. This compares to $15.4 million, including non-cash share-based compensation expense of $0.6 million for the same period in 2024. The increase in R&D expenses of $3.5 million was primarily driven by higher manufacturing costs for Zesturi and costs associated with the Phase III Utopia trial for UGN103, partially offset by lower clinical trial costs and regulatory expenses in connection with Zesturi. Selling, general, and administrative expenses for the second quarter of 2025 were $43.2 million, including non-cash share-based compensation expense of $2.3 million. This compares to $30.1 million, including non-cash share-based compensation expense of $3 million for the same period in 2024.

The year-over-year increase of $13.1 million was primarily driven by Zesturi commercial preparation activities, as well as an increase in overall commercial costs. We reported non-cash financing expense related to the prepaid forward obligation to RTW Investments of $4.6 million in the second quarter of 2025, compared to $5.8 million in the same period in 2024. Interest expense related to the term loan facility with funds managed by Pharmacon Advisors was $4.1 million in the second quarter of 2025, compared to $3.5 million in the same period in 2024. The increase was primarily driven by interest expense related to the third tranche of the loan that was funded in September 2024. We do not intend to draw down the fourth and final tranche of $75 million that is available to us at our discretion until August 29, 2025.

Net loss was $49.9 million, or $1.05 per basic and diluted share in the second quarter of 2025, compared with a net loss of $33.4 million, or $0.82 per basic and diluted share in the same period in 2024. As of June 30, 2025, cash, cash equivalents, and marketable securities totaled $161.6 million. Turning now to guidance, our full-year guidance for Jelmyto remains unchanged. We continue to expect full-year 2025 net product revenues from Jelmyto to be in the range of $94 to $98 million, and this implies year-over-year growth of approximately 8% to 12% over the $87.4 million in demand-driven Jelmyto sales in 2024. This excludes the $3 million in createx sales reported in 2024. Guidance on full-year 2025 operating expenses is also unchanged and is expected to be in the range of $215 to $225 million, including non-cash share-based compensation expense of $11 to $14 million.

We anticipate operating expenses to decrease modestly over the remainder of the year, reflecting the impact of several non-recurring costs incurred during the first half of 2024, partially offset by the sales force expansion in the second half of the year. These non-recurring costs totaled approximately $15 million and included expenses related to the acquisition of UGN103, preparations for the Zesturi ODAC, our national launch meeting for Zesturi, and manufacturing expenses for Zesturi, which were accounted for as R&D expense prior to FDA approval. That concludes our prepared remarks. We are now ready to open the call for questions. Operator?

Speaker 5

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 *11 on your telephone and wait for your name to be announced. To withdraw your question, please press *11 again. Please stand by while we compile the Q&A roster. Our first question comes from Tara Bancroft with TD Cowen. Tara, go ahead with your question.

Thanks, and good morning. Thanks for taking the questions. I have to ask the obligatory first question on all of our minds. Is there anything that you can offer on metrics you've hit so far for July, like I mean script rate, number of active accounts or prescribers that you have, or really anything qualitative, like the perceived level of pent-up demand from those who were maybe waiting to get a TURBT to instead receive Zesturi, if any, things like that? Thank you.

Yeah, great question, Tara Heitz, Liz. I'm going to ask David to comment, and then I'll probably add some color as well. David.

Speaker 1

Yeah, thanks for the question. We're really excited by the positive receptivity of not only the healthcare providers that we have engaged, but also the payer community. As we heard prior to launch, they're very eager for a new treatment option, and they took on the Zesturi product profile with great enthusiasm. We are very pleased with how we've heard about it. In the stage of the launch, as we said, we're really actively engaging physicians. We're helping them identify sites of care, and importantly, we're also continuing to make sure that market access, we lay the groundwork for market access so that all the patients have access to the product per label. Thank you for the question, and we'll be looking forward to sharing more results in the future.

Speaker 5

Yeah, Tara, look, I'll give you a little bit more color on that. One, we're not going to give metrics at this point. I'm sure everybody would love to have them, but it's still very early for us. What I will tell you is that we've all been spending a lot of time out in the field and talking to doctors, and to David's point, there's a lot of excitement. What you hear from doctors is they all have patients. I want to sort of put a note on patients because you know when you launch Jelmyto, it's like I have a patient. When we talk to doctors today, they have several patients. The biggest hurdle, frankly, is reimbursement, which we knew.

I can tell you that I went to an event last week with a lot of community practices and doctors, and the first thing they say is, "As soon as you get a permanent J-code, as soon as you get a permanent J-code, I've got patients waiting." We've always said there would not be a bolus of patients. What I can tell you is that our PEFs are coming in, patient enrollment forms, so the top of the funnel. We're very happy with where we're going there. The team, as David said, is working on the sites of care, pulling those through, dosing, really getting patients dosed. I would say at this point, we're very optimistic. We feel really good about where we are.

We think the consensus, as we said, for the year, we are still aligned with that and have the opportunity to see some real uptake over the next few months. I do think David commented this in the prepared remarks that you will see an acceleration after the first of the year when we have the J-code. We have hospitals, we have institutions, and we've got some large practices that are all willing to write. It's not like no one's willing to do it during the miscellaneous code. You do see a big difference in sort of attitude kind of before and after. The good news is that all of the metrics, the feedback we're getting, have not talked to one doctor who said, "No, I don't see a role for this." None of them, frankly, say they're going to really limit it.

Again, a lot of excitement around using this in multiple patients in their practice. Hopefully that extra color helps without giving very specific numbers for you. David also mentioned sites of care. We have set up a lot of sites of care, and we're on track with where we need to be and the number of sites of care that we already have set up so far to deliver what we've stated we would deliver for the year. Hopefully that helps.

Yeah, definitely. That's all very helpful. Thank you so much.

We're going to invite for our next question. Our next question comes from Michael Schmidt with Guggenheim Securities. Michael, go ahead with your question.

Hey, guys. Good morning. Thanks for taking my questions. Perhaps a follow-up just on the early launch here. We've certainly had some very positive feedback from urologists as well that we spoke with in terms of intent to prescribe the therapy. I'm just curious, what are you seeing so far around the reimbursement process early on using the miscellaneous code? I'm just curious if you could comment perhaps how much time it takes in terms of intent to prescribe until sort of conversion to paid prescription or anything along those lines would be helpful. I had a follow-up.

Yeah, sure. Go ahead, David.

Speaker 1

Yes, thank you for the question, Michael. I'll just comment on the initial process in terms of educating accounts. As we discussed in our prepared remarks, we are really focused on a group of around 2,000 providers that have demonstrated a willingness to adopt product during this particular period. That's pretty much what we're seeing in terms of interest right there. One of the things we do, which is very similar to what we did with Jelmyto at that launch, is we spend a good amount of time educating them on the actual process for claims and billing and then reimbursement. We educate them fully on that. It's white-glove service.

With that, they have the reassurance of knowing that when they enroll a patient, they know what that patient's copay is going to be, they know what the coverage is going to be, and the office feels more reaffirmed in terms of how that process is going to work. As you know, with the miscellaneous J-code period, it is a little bit of a different process because it's manual. What we're seeing so far is that when we engage the practices, they feel assured that what they're doing is setting them up for a positive experience.

Speaker 5

is too early to give. Too early to say we haven't had any paid claims yet. It is too early to sort of say how long it is going to take. As we start to see that coming through, we'll be able to give you more color on that. It is too early to see that.

Right. If you were to compare the initial experience of the Zesturi launch to your experience with Jelmyto five years ago, how much commercial synergies are there in place today, given your commercial footprint around the Jelmyto product, and any key learnings as you launched Zesturi essentially into a very similar market here?

Yeah, since Mark and I were the only two people here when we launched Jelmyto, I'll give you some comment and ask Mark to add anything. I think it's similar in a lot of ways in the sense of what you have to deal with with the J-code, what you have to deal with with reimbursement, what you have to deal with identifying patients, and what you have to deal with, frankly, for an office to get set up, set up with a distributor. The good news is obviously a lot of these offices are already set up. All we have to do is add in Zesturi where they already were. There is a little bit of paperwork that happens there. Absolutely, some of the first physicians that we see that are writing for Zesturi are writers of Jelmyto, which makes a lot of sense.

What we also are seeing is that, for the most part, people are really happy with the support that we gave them with Jelmyto and are happy with the support that they're getting. The physicians that I've personally interacted with have commented about particularly our reimbursement team because that's the number one thing right now and how good they are, how knowledgeable they are, how helpful they are. I'm going to let Mark talk about the numbers because I think that's a big, big difference between what we heard when we launched Jelmyto versus what we're hearing now. Mark.

Speaker 7

Yeah, thanks, Liz. It's, I think, obvious to many on the call that we're dealing with a completely different demographic, so to speak, and a demographic opportunity. Upper tract urothelial carcinoma, the target of Jelmyto use, is a very small population of patients. On average, most practicing urologists will see one or two patients a year. It's hard to find the patients, and it's hard to find individuals treated with Jelmyto, which I think explains a lot of the experience with why the Jelmyto ramp has been what it has been. That's very different than what we're dealing with with the Zesturi launch. There are lots of patients who qualify by the label alone for the use of this drug, and physicians are exceedingly familiar with this population of patients. These are people we're seeing in the office on a very regular basis.

I do think, although as Liz pointed out, many of the sort of mechanical issues related to bringing the drug into the practice are similar and will be familiar to people who have used Jelmyto. The opportunity, the ease of administration, the fact that this can be given in an office with essentially minimal physician involvement, this can be given by a nurse, will really change the way the Zesturi experience looks compared to our experience previously with Jelmyto launch.

Super. Let's just squeeze one more, and this one's on UGN103. Now with the Utopia study fully enrolled, I was just curious if you had the chance to have any additional discussions with the regulators in terms of, you know, sort of coming off of the panel earlier this year in terms of whether the study is, in fact, supportive of potential approval. From a clinical perspective, is the goal to essentially reproduce the Envision data, or is there an opportunity to differentiate clinically with 103? Thanks so much.

Speaker 5

Yeah, no, great question. We have not interacted. We don't have enough data yet, so we're waiting on additional data before we interact with the FDA. We will absolutely do that and have feedback for you prior to the end of this year. I think that's the timing on that. The goal is to replicate, and we actually purposely did that because what we didn't want to do is introduce any potential issues that would muddy the waters as far as the data is concerned. We tried to replicate almost exactly the Envision study. There, unfortunately, there's no differentiation, but fortunately, what we're doing is trying not to introduce any biases. Our expectation is that the FDA will accept the study as they had previously communicated, mainly because this is a new formulation, and they actually have UGN-102, Zesturi, as a historical control now.

We do plan to interact again with them. We'll have feedback for you before the end of the year, that's our expectation, and that's what we're moving forward with. Having said that, we and ourselves want to continue to expand the use of UGN-103. We are in the planning of additional lifecycle management studies that we will start fairly quickly on UGN-103, regardless of the FDA feedback. We have other studies that we want to do in other populations, and we'll be starting those as quickly as possible.

Thank you.

Our next question comes from Leland Gershell with Oppenheimer. Leland, go ahead with your question.

Hi, good morning, and thanks for taking our questions, a few from us. With respect to the first phase of the launch, pre the J-code assignment, I'm wondering, as you're going after those 2,000 docs you've identified, total adopters, can you share how those break down with respect to community versus academic docs? Should we think of the academic, those who practice in an academic setting, as maybe having easier access to the medication? Is the miscellaneous J-code easier in the hospital setting or through that process? Is there a P&T committee dynamic that we should consider for Zesturi in the hospital setting? If you could share any color around that as we think about 2025 sales before the J-code kicks in. Thank you.

Yeah, absolutely, David.

Speaker 1

Yeah, thanks, Leland. The majority of that 2,000 physician, I'll say, early adopter list that we've identified reside in the community, and there are some in institutional settings. As you know, some have privileges in hospitals as well. When we think about them gaining access to Zesturi, there is a spectrum. In private practice, as we've mentioned, there's historically some hesitation there. What we try to do is help them identify a site of care where they can administer Zesturi for the first time and gain experience. That often is in a hospital outpatient setting. If it is a specific hospital account, I think that process varies, but generally speaking, you'll see that they have formal P&T reviews.

One of the things we did immediately upon launch was engage the major accounts so that we could begin working with them to provide the clinical, the operational, and financial information to support a successful P&T review.

Okay, great. Just another question with respect to the Utopia trial. Do you think the FDA would ask for longer durability data or anything that may be incremental to what was shown with Envision, or do you think it truly would be kind of a replicate of the Envision data set that could get 103 approved? Thank you.

Speaker 7

Thanks, Leland. Yeah, we're expecting it to be similar to what we presented for Envision. We're going to talk to the FDA about their expectations, but our expectation is that it would mirror similar types of requirements as Envision, namely concentrating on CR with some reasonable amount of durability data. That would obviously be something that we'd have to talk to the agency about.

Okay, thank you.

Speaker 5

Our next question comes from Rahajuram Vallahu with H.C. Wainwright & Company. Go ahead with your question.

Thanks very much for taking our questions, and congratulations on all the progress so far. I wanted to ask, first of all, about clarification of a couple of commercial things. Firstly, you know, you alluded to once the formal J-code assignation is complete at the beginning of next year, that there would be outreach facilitated by this to a broader group of prescribers. Can you maybe quantify for us how many more prescribers are likely to be targetable beyond the initial 2,000? I also wanted to ask if you are seeing any evidence that the commercial availability of Zesturi and the increased visibility of the company overall is having any potential beneficial spillover effects on Jelmyto itself, and if you're seeing any noteworthy re-acceleration of momentum in Jelmyto because Zesturi is now available.

Yeah, thanks, Rom. David.

Speaker 1

Hey, Rom, thanks for the question. On your question around how we're going to engage the total universe, as we said, we are focused on the 2,000 that we think are very important to the early stages of a launch. It doesn't mean that we won't see others in the universe if they're in the same office. Broadly speaking, as we turn the corner into 2026, we will expand our efforts beyond that 2,000, and we'll begin very rapidly then expanding our reach to a greater number of them. I would say by the middle of next year, we're going to see we're going to be broadly engaging everyone in that total universe. Keep in mind that universe also includes in each office, there's physician assistants, there's nurses, so our efforts go well beyond just the HCP.

With regard to your question on Jelmyto, it's too early to say that, but what I can tell you, what we've observed so far is that, as Liz mentioned, those who've used Jelmyto definitely understand the technology behind Zesturi. What I would say as we move forward in time, as we penetrate the overall market for low-grade, intermediate-risk non-muscle invasive bladder cancer and Zesturi, we will see that that increased reach and frequency through the universe will support the continued steady growth of Jelmyto.

Great. Just one follow-up with respect to UGN103. I was wondering if at this juncture you have any reason to believe that because of the characteristics of the new formulation, 103 might have advantages in safety, tolerability, or ease of administration relative to Zesturi itself.

Speaker 7

Thank you. The answer is we don't, and we didn't expect any real changes. For the audience, just to remind you, the principal issues related to this formulation relate to solubility, ease of reconstitution, related to a change in the excipients of the preparation. We don't expect a change in terms of the clinical profile, and it's premature for us to talk further about that. We will be happy to share those data when we have them later in the year.

Thank you.

Speaker 5

As a reminder, to ask a question, you will need to press *11 on your telephone and wait for your name to be announced. To withdraw your question, please press *11 again. Our next question comes from Paul Choi with Goldman Sachs. Paul, go ahead with your question.

Hi, thank you. Good morning, and thanks for taking our questions. I also want to follow up on Utopia, maybe ask, you know, is there anything in terms of either the data or product profile that you might call out that would allow you to address additional segments of the low-grade, intermediate-risk population that you feel like you can't currently tackle with Zesturi? Would there be any sort of incremental subset of patients that might be better candidates for that product? My second question on Zesturi is just, I guess, as you think about sort of the product procedural flow in doctors' offices, can you maybe just comment on how you're thinking about non-physicians, such as licensed nurse practitioners, as a percentage of the mix? Are there any other requirements for non-urologists to use the product? Thanks for taking our questions.

Go ahead, Mark. You want to answer the Utopia question? Are there any?

Speaker 7

Yeah, sure. Hi, Paul. Thank you for that. The answer to the first question is no. As Liz mentioned, we are really formatting the evaluation of UGN103 in the Utopia trial in exactly the same manner as we did Zesturi and Envision. It would be applicable to the same population of patients, and we wouldn't expect a change in terms of the target population it would be used in initially. What you're anticipating, I think, in your question is the possibility of us doing additional clinical trials, which is something we have to talk about and think about, and Liz will ultimately make a decision about. Currently, the plan is for the same group of patients with that drug when it becomes available and is approved.

Speaker 5

Yeah, as I mentioned earlier, we absolutely expect to expand UGN103 into other patient populations, not because it's different than Zesturi from a clinical perspective, but just because we would be doing that with UGN102. It makes more sense for us to be doing that with UGN103, assuming the data is very similar as the data starts to play out. That's our expectation. We will expand absolutely into other patient populations, not really driven by any differences we see. David, you want to answer the question around Zesturi?

Speaker 1

Yeah, on the question of Zesturi and actually who might be administering this in the office, what we're hearing early on is that obviously the physician will want to be understanding the entire process, the ordering all the way through administration. We do expect, and we've heard this consistently, that as practices get more experience, it will really fall on the shoulders of someone specifically who does intravesical therapies, likely a nurse. That's pretty much what we're hearing right now, consistent with what we learned before launch.

Speaker 5

We are engaging all people in the practice, right? Everybody from physicians to your PAs to your, you know, the reimbursement team. From that perspective, included in the 8,500 target are other targets outside of physicians. We'll continue to do that. This is a full, comprehensive account sell. It needs to be. In the beginning, clearly, the physician's conviction around wanting to use it is going to drive the early adoption. Thanks, Paul. Our next question comes from Aiden Husenoff with Ladenburg. Aiden, go ahead with your question.

Hi, good morning, everyone. Thank you for taking questions, and congrats with the quarter. A good couple of questions I want to ask. First, I wanted to ask that if there were not questions about permanent J-code, if we didn't have issues with J-code this year, permanent J-code this year, how many patients do you think it would be possible for you to dose in 2025? The reason I'm asking is because Envision trial enrolled very quickly. I think 20 patients, 10 months across 90 sites. I was trying to understand if we did not have reimbursement issues at this point, how many patients would it be possible to dose in 2025?

Yeah, look, that's a great question. Not one that we're going to speculate on, but it suffices to say that absolutely, it's a significant number of patients. As I mentioned earlier, the number one, you know, the number one barrier right now is reimbursement. It's not around the desire for clinical use, and that's a good thing. That's a really good thing. I mean, rarely do you roll out where there's not questions, you know, more questions around the clinical data, the clinical use, the patient identification, and we're not hearing that. The only, the only, again, you know, in all the conversations I've had, it's only been around reimbursement. That's actually a good thing because we can solve that, right?

It takes time to solve that, but once we start getting explanation of benefits, EOBs out there, once they start to see, you know, what we're hearing from a lot of the practices is, okay, I'll try it on one patient. They typically want to be a Medicare fee-for-service patient because that's kind of the one that they feel most confident about. Once they get that experience and see a positive reimbursement, then they're more willing to expand beyond to other patients. I think, you know, again, without speculating on the number, it would be significantly more. There's no doubt about it. I think the good news is when you're out there talking to doctors, that's the question. It's really around reimbursement and not around the clinical, you know, usage or utility or need for this drug. I think that's a very good place for us to be.

When do you think you'd be able to provide short-term and long-term guidance for Zesturi? I know that we're talking about Zesturi being overall targeting a $5 billion market, but we're also trying to understand what would be the peak sales. Just wanting to understand the level of comfort to provide both short-term and long-term guidance for the drug.

Speaker 7

Yeah. Aiden, this is Chris. Thanks for the question there. I think we've been pretty clear in terms of the potential. We view Zesturi as over a billion-dollar opportunity by itself. In terms of providing more short-term guidance, I think we'll get through the early initial launch phase this year and look to potentially provide guidance for 2026.

Okay, thanks so much.

Speaker 5

Thank you. Thanks, Aiden. This concludes the question-and-answer session. I would now like to turn it back to Liz Barrett for closing remarks. I just want to take an opportunity to say thank you to everybody. Thanks for hanging in there with us over the years. It's an exciting time for us. We're still in the early days, but things are looking great, and we're very excited about kind of where we are and where we are to be. We'll keep you guys posted as things play out. Thanks a lot. We appreciate it. Operator, you can disconnect at this moment. Thank you. Thank you for your participation in today's conference. This does conclude the program. You may now disconnect.

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