UroGen Pharma Ltd. Q2 FY2025 Earnings Call

Good day, and thank you for standing by. Welcome to the UroGen Pharma Second Quarter 2025 Earnings Call. 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.

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 ZUSDURI, 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, ZUSDURI being the primary growth driver for UroGen, the potential benefits of our products 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.

Thank you, Vincent. On June 12, we achieved a defining milestone for UroGen with the FDA approval of ZUSDURI 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 recurrent and repeat surgeries year after year with no approved alternatives. ZUSDURI 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 recurrent and treatment-free living. We are proud to be leading that shift. ZUSDURI is UroGen's second commercial product and marks our transition from a rare disease-focused company to a scaled multiproduct 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 ZUSDURI, 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 1, 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 ZUSDURI. Our commercial organization has a deep understanding of how care is delivered in neurology 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 ZUSDURI, 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 the 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. UGN-301, 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 UGN-103 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 UGN-104, 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 30. We believe we have the necessary capital to fund the ZUSDURI 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 medicines, we could not do it without you. With two commercial products and an advancing pipeline and the 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?

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 ZUSDURI as a meaningful advancement in how we care for this population. And for the first time, we can offer patients and their health care 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. ZUSDURI offers a new nonsurgical treatment approach. ZUSDURI is administered as an intravesical installation 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 ZUSDURI are both robust and continue 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 a 24-month duration of response of 72.2% by Kaplan-Meier estimate for patients who achieved a complete response of three months after the first installation of ZUSDURI. 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 remained 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 ZUSDURI 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 ZUSDURI. I'll now briefly update you on the clinical pipeline. UGN-301 is our investigational anti-CTLA4 antibody delivered via RTGel. It is currently being evaluated in the Phase I trial both as monotherapy and in combination with UGN-201, our TLR7 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 ZUSDURI and JELMYTO. The Phase III UTOPIA trial is evaluating UGN-103, the successor to ZUSDURI, 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 UGN-104, our next-generation formulation of JELMYTO. We recently initiated a single-arm Phase III trial and patient screening is underway. UGN-501, 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.

Thank you, Mark. As my colleagues have shared, we believe ZUSDURI 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 ZUSDURI 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 health care 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 health care 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 ZUSDURI will benefit appropriate patients. Even at this early stage, we are encouraged by the level of interest we're seeing. Awareness around ZUSDURI is strong and health care providers are eager to learn about the profile of ZUSDURI and engage on appropriate patient types. Customer questions focus on the clinical, operational, and financial considerations to begin treating with ZUSDURI. 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 ZUSDURI. 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 ZUSDURI 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 ZUSDURI 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 noncash share-based compensation expense of $0.4 million. This compares to $15.4 million, including noncash 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 ZUSDURI and costs associated with the Phase III UTOPIA trial for UGN-103, partially offset by lower clinical trial costs and regulatory expenses in connection with ZUSDURI. Selling, general and administrative expenses for the second quarter of 2025 were $43.2 million, including noncash share-based compensation expense of $2.3 million. This compares to $30.1 million, including noncash 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 ZUSDURI commercial preparation activities as well as an increase in overall commercial costs. We reported noncash 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 Pharmakon 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 to 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 million 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 CREATES Act sales reported in 2024. Guidance on full-year 2025 operating expenses is also unchanged and is expected to be in the range of $215 million to $225 million, including noncash share-based compensation expense of $11 million to $14 million. We anticipate operating expenses to decrease modestly over the remainder of the year, reflecting the impact of several nonrecurring costs incurred during the first half of 2025, partially offset by the sales force expansion in the second half of the year. These nonrecurring costs totaled approximately $15 million and included expenses related to the acquisition of UGN-501, preparations for the ZUSDURI ODAC, our national launch meeting for ZUSDURI and manufacturing expenses for ZUSDURI, 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?

Our first question comes from Tara Bancroft with TD Cowen.

So 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, 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 ZUSDURI, if any, things like that?

Yes. A great question, Tara. It's Liz. And I'm going to ask David to comment, and then I'll probably add some color as well. So David?

Yes, thank you for the question. We're really excited about the positive response from both the healthcare providers we've engaged and the payer community. Before the launch, they expressed eagerness for a new treatment option and received the ZUSDURI product profile with enthusiasm. We are pleased with the feedback we've been getting. During the launch phase, we are actively engaging physicians and assisting them in identifying care sites. Importantly, we have also ensured that we have established market access so that all patients can access the product according to its label. Thank you for the question, and we look forward to sharing more results in the future.

Yes, Tara, I can provide more insight on that. We're not ready to share specific metrics yet, as it's still quite early for us. However, we've been actively engaging with doctors in the field, and there is a lot of enthusiasm. Doctors are eager to treat their patients, and it's worth noting that when we launched JELMYTO, doctors were talking about individual patients, but now they are discussing multiple patients. The main challenge we face is reimbursement, which we anticipated. At a recent event with community practices, doctors expressed that they are ready to proceed as soon as we have a permanent J-code. We've always expected a gradual increase in patient numbers. Nonetheless, our patient enrollment forms are coming in, and we feel positive about our progress in that area. Our team is diligently working on care sites and ensuring patients are getting treated. Overall, we're quite optimistic about our current position. We believe we are still aligned with our yearly expectations, and we see potential for significant growth in the coming months. David mentioned in his prepared remarks that we expect to see an uptick after the new year when the J-code becomes available. We have hospitals, institutions, and several large practices ready to proceed. They're willing to continue using the miscellaneous code in the meantime, but there's a noticeable difference in attitude before and after a J-code. The encouraging news is that every doctor I've spoken to sees value in our product and none of them indicate that they plan to restrict its use. There is considerable excitement about utilizing this for multiple patients in their practices. I hope this provides the additional context you were looking for without delving into specific numbers. Additionally, as David mentioned, we've established numerous care sites, and we are on track with our goals for the year in that regard. I hope this information is helpful.

Our next question comes from Michael Schmidt with Guggenheim.

Perhaps a follow-up just on the early launch. Yes, we've certainly had some very positive feedback from urologists as well that we spoke with in terms of intent to prescribe the therapy. But just curious what you're seeing so far around the reimbursement process early on using the miscellaneous codes. 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. And then I had a follow-up.

Yes, sure. Go ahead, David.

Yes. I'll comment on the initial process of educating accounts. We are focused on a group of about 2,000 providers who are willing to adopt the product during this period. This interest is what we are observing. Similar to what we did with JELMYTO at launch, we spend significant time educating them on the claims, billing, and reimbursement processes. We provide a white glove service, which gives them reassurance that when they enroll a patient, they understand the patient's co-pay and coverage, making the office feel more confident in how the process will work. With the miscellaneous J-code period, the process is a bit different since it's manual. However, when we engage the practices, they feel assured that they are setting themselves up for a positive experience.

It's still too early to provide any specific details, so we haven't received any paid claims yet. As we begin to see these claims come in, we'll be able to offer more insight on the timeline. However, right now, it's too early to determine that.

Right. If you compare the initial experience of the ZUSDURI launch to your experience with JELMYTO five years ago, how much commercial synergy is in place today considering your commercial footprint around the JELMYTO product? Are there any key learnings as you launch ZUSDURI into a very similar market?

Yes. Since Mark and I were the only two here when we launched JELMYTO, I'll provide some comments and ask Mark to add anything. It's similar in many ways concerning the J-code, reimbursement, patient identification, and setting up the office with the distributor. The good news is that many of these offices are already established, so we just need to integrate ZUSDURI into their existing setup. There will be some paperwork involved. Many of the first physicians prescribing ZUSDURI are also writers of JELMYTO, which is logical. We've noticed that, overall, people appreciate the support we provided with JELMYTO and are satisfied with the support they are receiving now. The physicians I've interacted with have praised our reimbursement team, as that is the top priority for them right now, highlighting their expertise and assistance. Now, I will let Mark discuss the numbers, as I believe there is a significant difference between what we experienced during the JELMYTO launch and what we are observing now. So Mark?

Thank you, Liz. It's clear to many on the call that we're addressing a significantly different demographic opportunity. Upper tract urothelial carcinoma, which is the target for JELMYTO, represents a very small patient population. On average, most urologists encounter only one or two patients each year, making it challenging to identify individuals to treat with JELMYTO. This likely accounts for the slow ramp-up we’ve seen. In contrast, with the ZUSDURI launch, there are many patients who meet the criteria established for the drug, and physicians are very familiar with this patient group. These are individuals we see regularly in the office. While there are some mechanical aspects of introducing the drug into practice that are similar to those experienced with JELMYTO, the opportunity and ease of administering ZUSDURI will significantly enhance the patient experience. It can be administered in an office setting with minimal physician involvement, even by a nurse, which will markedly differ from our previous experience with the JELMYTO launch.

Let's squeeze one more question in, and this one is about UGN-103. Now that the UTOPIA study is fully enrolled, I am curious if you have had any additional discussions with the regulators regarding whether the study supports potential approval. From a clinical standpoint, is the aim to essentially replicate the ENVISION data, or is there a chance to differentiate clinically with 103?

Yes, that's a great question. We haven't interacted yet, as we don't have enough data. We are waiting for more data before engaging with the FDA, but we will definitely do so and will provide feedback before the end of this year. Our goal is to replicate the ENVISION study closely. We aimed to avoid introducing any potential issues that might complicate the data. Unfortunately, there’s no differentiation, but we're working to avoid any biases. We expect the FDA to accept the study as they previously indicated, especially since this is a new formulation and UGN-102, ZUSDURI, serves as a historical control. We will interact again with the FDA and will have feedback for you by year-end. Moreover, we want to continue expanding the use of UGN-103. We are planning additional life cycle management studies for UGN-103 that we intend to start fairly soon, regardless of the FDA feedback, and we have other studies lined up for different populations that we will initiate as quickly as possible.

Our next question comes from Leland Gershell with Oppenheimer.

With regard to the first phase of the launch before the J-code assignment, I'm curious about how the 2,000 doctors you've identified as early adopters break down between community and academic practices. Should we assume that those in academic settings may have easier access to the medication? Is the miscellaneous J-code more manageable in hospitals or through that process? Are there any dynamics from the P&T committee that we should consider for ZUSDURI in hospital settings? Any insights you could share would be helpful as we think about 2025 sales ahead of the J-code implementation.

Yes, absolutely. David?

Yes. Most of the 2,000 early adopters we have identified are in community settings, although some are in institutional environments, and some have hospital privileges. When we consider their access to ZUSDURI, it's a diverse scenario. In private practice, as we've noted, there has historically been some reluctance. Therefore, we aim to assist them in finding a care site where they can administer ZUSDURI for the first time and gain experience, which often takes place in a hospital outpatient setting. If it's a specific hospital account, the process may differ, but generally, they will have formal pharmacy and therapeutics reviews. Immediately after the launch, we engaged key accounts to start providing them with the necessary clinical, operational, and financial information needed for a successful review.

Okay. Great. And then 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?

Yes, we expect it to be similar to what we presented for ENVISION. We plan to discuss the FDA's expectations with them. However, we anticipate that it will have similar requirements to ENVISION, primarily focusing on complete response with a reasonable amount of durability data. This will obviously need to be discussed with the agency.

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

Congratulations on all the progress so far. I wanted to ask, first of all, about clarification of a couple of commercial things. Firstly, you alluded to once the formal J-code designation 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? And then also, I wanted to ask if you are seeing any evidence that the commercial availability of ZUSDURI 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 reacceleration of momentum in JELMYTO because ZUSDURI is now available?

Yes. David?

In response to your question about how we plan to engage the entire market, we are concentrating on the 2,000 key prescribers that are vital for the early launch phase. This doesn't exclude encountering additional prescribers within the same offices. Looking ahead to 2026, we intend to broaden our outreach beyond those 2,000 and will quickly expand our engagement to include a larger group. By the middle of next year, we expect to be reaching out to everyone in that wider market. It's important to note that this market also encompasses physician assistants and nurses in each office, so our initiatives will extend beyond just healthcare professionals. Regarding JELMYTO, it's still early to draw conclusions. However, we have observed that those who have utilized JELMYTO clearly grasp the technology associated with ZUSDURI. As we move forward and increase our presence in the market for low-grade intermediate risk non-muscle invasive bladder cancer and ZUSDURI, we anticipate that this expanded reach will contribute to the ongoing steady growth of JELMYTO.

Great. And then just one follow-up with respect to UGN-103. 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 ZUSDURI itself?

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. But we don't expect a change in terms of the clinical profile, and it's premature for us to talk further about that, and we will be happy to share those data when we have them later in the year.

Our next question comes from Paul Choi with Goldman Sachs.

I also want to follow up on UTOPIA and maybe ask, 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 tap with ZUSDURI? And just sort of would there be any sort of incremental subset of patients that might be better candidates for that product? And my second question on ZUSDURI 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 nonphysicians such as licensed nurses practitioners as a percentage of the mix? And are there other requirements for non-urologists to use the product?

Go ahead, Mark. Do you want to answer the UTOPIA question? Are there any...

Yes, sure. So the answer to the first question is no. As Liz mentioned, we are really formatting the evaluation of 103 in the UTOPIA trial in exactly the same manner as we did ZUSDURI and ENVISION. So 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. But currently, the plan is for the same group of patients with that drug when it becomes available and is approved.

Yes. However, as I mentioned earlier, we do expect to extend UGN-103 to other patient populations, not because it is clinically different from ZUSDURI, but because it aligns better with our plans for UGN-102. This approach makes sense for UGN-103, assuming the data remains consistent as we move forward. Our expectation is to expand into other patient populations, but this isn’t driven by any observed differences. David, would you like to address the question regarding ZUSDURI?

Yes. So on the question of ZUSDURI 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. But we do expect and we've heard this consistently that as practices get more experience, that it will really fall on the shoulders of someone specifically who does intravesical therapies, likely a nurse. And so that's pretty much what we're hearing right now, consistent with what we learned before launch.

And we are engaging all people in the practice, right, everybody from physicians to your PAs to the reimbursement team. So from that perspective, included in the 8,500 targets are other targets outside of physicians. So we'll continue to do that. This is a full –- a comprehensive account sell. It needs to be. But in the beginning, clearly, the physicians' conviction around wanting to use it is going to drive the early adoption.

Our next question comes from Aydin Huseynov with Ladenburg.

Congrats on the quarter. A good couple of questions I want to ask. So 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? So the reason I'm asking because ENVISION trial enrolled very quickly, I think, 220 patients, 10 months across 90 sites. I was trying to understand if we did not have reimbursement issues at this point, so how many patients would it be possible to dose in 2025?

That's a great question, but we're not going to speculate on it. It's clear that there are a significant number of patients, and the main barrier we face is reimbursement, not a lack of interest in clinical use. That's positive because it means we can work on the reimbursement issue. It may take some time, but once we start getting explanations of benefits, more practices will be willing to try it with at least one patient. They often prefer starting with a Medicare fee-for-service patient, as they feel most confident with that. If they see positive reimbursement from that experience, they'll be more inclined to expand to other patients. While I won't speculate on the exact number, it would certainly be much higher. The encouraging part is that discussions with doctors center around reimbursement rather than clinical usage or the necessity of this drug, which puts us in a good position.

When do you think you would be able to provide both short-term and long-term guidance for ZUSDURI? I understand that we are discussing a target market of $5 billion, but we also want to gain insight into what the peak sales might be. I would like to know your level of comfort in providing that short-term and long-term guidance for the drug.

Yes. Aydin, this is Chris. I mean I think we've been pretty clear in terms of peak potential. We view ZUSDURI as over $1 billion 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.

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

Yes. 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 head to be. And we'll keep you guys posted as things play out. So 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.