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UroGen Pharma Ltd. Q1 FY2026 Earnings Call

UroGen Pharma Ltd. (URGN)

Earnings Call FY2026 Q1 Call date: 2026-05-06 Concluded

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Speaker-labelled transcript of the call.

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8-K earnings release

Item 2.02 release filed around the call (2026-05-06).

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10-Q filing

The quarterly report covering this quarter (filed 2026-05-06).

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Guidance

from the 8-K filed May 6, 2026
Metric Period Guided Actual
net product revenue for JELMYTO full-year 2026 $97M – $101M
operating expenses full-year 2026 $240M – $250M
non-cash share-based compensation expense full-year 2026 $20M – $24M

Transcript

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Operator

Good day, and thank you for standing by. Welcome to the UroGen Pharma Q1 2026 Results Earnings Call. 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 Head 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 at investors.urogen.com. Joining me today are Liz Barrett, President and Chief Executive Officer; Dr. Mark Schoenberg, Chief Medical Officer; and Chris Degnan, Chief Financial Officer. On today's call, we will be making certain forward-looking statements. These may include statements regarding our ongoing commercialization activities related to ZUSDURI and JELMYTO, our ongoing and planned clinical trials and nonclinical trials, commercial and clinical development milestones, market and revenue opportunities, our commercialization strategy and expectations as well as anticipated data, regulatory filings and decisions, the importance of ZUSDURI's growth for UroGen's long-term strategy, the potential benefits of our products and product candidates, future R&D efforts and milestones, our corporate goals and 2026 financial guidance, among other things. These forward-looking statements are based on current information, assumptions and expectations that are subject to change. A description of potential risks can be found in our earnings press release and latest SEC disclosure documents. You are cautioned not to place undue reliance on these forward-looking statements, and UroGen disclaims any obligation to update these statements. I'll now turn the call over to Liz.

Thanks, Vincent. Good morning, 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 ZUSDURI launch, the Board and I made the decision a few months ago that I would assume direct oversight of the commercial organization, resulting in the departure of David Lin. For the past several months, I have engaged directly with our commercial team and key external stakeholders, and this change has enhanced our ability to remain agile, promote efficient decision-making and leverage the expertise of our executive team. Now turning to our results. We are very pleased by our performance in the first quarter, highlighted by $29.2 million in ZUSDURI revenue. This represents more than 100% quarter-over-quarter growth. As expected, the implementation of the permanent J-code in January marked a major inflection point, 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 value ZUSDURI brings to patients and physicians. As the first and only FDA-approved medicine for adults with recurrent low-grade intermediate risk non-muscle invasive bladder cancer, ZUSDURI offers a nonsurgical treatment in a disease historically managed through repeated surgical intervention. ZUSDURI's profile as a primary chemoablative therapy represents 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. These are the most important indicators we track as they reflect growing HCP confidence and successful integration of ZUSDURI into routine urology practice. Importantly, these growth trends were consistent throughout the quarter and not limited to the immediate period following the implementation of the J-code. This gives us confidence in the durability of the launch and supports our expectation for continued growth as we move through Q2 and the rest of the year. Patient enrollment forms, or PEFs, remain an important early indicator of demand, providing visibility into activity at the top of the funnel before it is reflected in new patient starts and revenue. In Q1, we saw continued sequential growth in PEF volume, which we believe reflects strong and expanded health care provider engagement. As we've shared, PEFs, new patient starts and doses all significantly outpaced JELMYTO in Q1, and we expect continued growth across all measures over the course of the year. In terms of conversion, the cycle time from PEF to treatment initiation was approximately 45 to 60 days in Q4, which was expected as sites worked through onboarding and workflow integration. In Q1, we continued to see improvement and expect this to continue over the course of the year, moving toward the 2- to 3-week range we see today with JELMYTO. We also see a continued shift toward greater utilization in community practices. In Q4, the mix was approximately 60% hospital and 40% community, and we are now approaching a more balanced mix, closer to 50-50 at quarter end. Given that approximately 70% of the overall market opportunity resides in the community setting, we expect this shift towards community practices will continue and will be an important driver of long-term growth for ZUSDURI. From an access and reimbursement perspective, we have open access across more than 95% of covered lives and reimbursement confidence has significantly improved among practices with a permanent J-code for ZUSDURI 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 ZUSDURI and continuing to improve patient conversion timelines. In parallel, we are beginning to expand our commercial approach to more directly engage patients, including targeted awareness efforts as we believe patients can be a key catalyst to drive adoption and ZUSDURI is in a unique position of providing both recurrence and treatment-free living. ZUSDURI addresses an estimated $5 billion annual market opportunity in recurrent low-grade intermediate risk non-muscle invasive bladder cancer, and we believe its differentiated clinical profile positions it to capture a meaningful share of that market. As adoption continues to build, we see ZUSDURI as a foundational treatment for adults with recurrent low-grade intermediate risk non-muscle invasive bladder cancer patients with the potential to evolve into a blockbuster therapy with peak annual revenues exceeding $1 billion. Turning to JELMYTO. We reported revenue of $21.7 million in the first quarter and continue to see a stable, predictable demand profile. We are also continuing to add new users, reflecting sustained confidence among urologists and remain on track to achieve our 2026 sales guidance of $97 million to $101 million. We continue to advance our pipeline, including UGN-103, our next-generation mitomycin-based intravesical therapy, where we will have established a clear regulatory pathway for adults with recurrent low-grade intermediate risk non-muscle invasive bladder cancer. We remain on track for our NDA submission in the second half of 2026 with potential approval in 2027. We also plan to expand this product into additional bladder cancer settings as part of our broader life cycle 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 Pharmakon Advisors during the quarter. This provides us with the flexibility to fully support the ongoing launch of ZUSDURI while continuing to invest in our next-generation pipeline with cash runway to and through profitability. Overall, we believe we are well positioned to execute on our strategy, build on our current momentum and deliver meaningful outcomes for our patients while generating long-term shareholder value. I will now turn the call over to Mark for a clinical update. Mark?

Speaker 3

Thank you, Liz. The American Urologic Association Annual Meeting will take place May 15 to 18 in Washington, D.C. UroGen will have a significant presence there, and we believe this is an important opportunity to engage with both community and academic urologists and further discuss the clinical value of ZUSDURI and JELMYTO. For UroGen, the national AUA meeting represents a highly relevant and meaningful forum to continue building awareness and health care provider engagement. Bladder cancer will be a central focus of this year's meeting, and it's important to clearly define where ZUSDURI fits within the evolving treatment landscape for NMIBC. In intermediate risk disease, the primary clinical challenge is the management of recurrence rather than progression. Patients commonly experience multiple recurrences, requiring repeated TURBT procedures under general anesthesia over time, which contributes to a significant cumulative treatment burden. Accordingly, both patients and physicians are focused on strategies that reduce the frequency of interventions and enable a more rapid return to normal daily activities. ZUSDURI was specifically designed to address this need. Its clinical benefit is driven by both its efficacy and mode of administration. In the Phase III ENVISION trial, which supported its FDA approval, ZUSDURI demonstrated a robust complete response rate of approximately 80% at 3 months and, importantly, durable outcomes over time. At 24 months, the probability of remaining event-free following complete response was approximately 72% based on Kaplan-Meier analysis. These data were recently published in the Journal of Urology and will be featured in a podium presentation at the upcoming AUA Congress. Importantly, median duration of response has not been reached in the ENVISION study at a median follow-up of 23.7 months after 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 decrease patients' treatment burden. In practical terms, it translates into longer recurrence-free intervals and extended periods without treatment. Equally important is how ZUSDURI is delivered. It is administered as a finite 6-dose chemoablative regimen in the outpatient setting without the need for surgery or ongoing maintenance therapy. In our experience, this allows for straightforward integration into routine clinical practice without significant changes to workflow or infrastructure. This approach is distinct from many therapies currently in development, which are typically evaluated in the adjuvant setting and administered following TURBT. These regimens often involve induction and maintenance therapy over extended periods, in some cases up to one year. ZUSDURI, by contrast, is designed as a primary nonsurgical therapy with a total treatment duration of 6 weeks. Taken together, this approach represents a meaningful shift in how this disease can be managed, offering durable disease control for a finite course of therapy while reducing treatment burden and enabling extended recurrence-free and treatment-free living. As we continue to gain real-world experience, understanding how these clinical benefits translate into routine practice is increasingly important. At the upcoming AUA Annual Meeting, UroGen will host a KOL panel focused on real-world experience with ZUSDURI, including patient selection, workflow integration, treatment patterns and patient outcomes. This event will be webcast and accessible through the company's website, and we believe it will provide important clinical perspective on how ZUSDURI is being incorporated into routine practice. Turning now to the pipeline. UGN-103 is our next-generation mitomycin-based formulation for recurrent low-grade intermediate risk non-muscle invasive bladder cancer, developed to build on the foundation established by ZUSDURI. It is designed to improve upon the current formulation with a shorter manufacturing process and a more streamlined reconstitution procedure while also having intellectual property coverage into December of 2041. We plan to submit an NDA for UGN-103 in the second half of this year based on results from the Phase III UTOPIA trial, which demonstrated a 77.8% complete response rate at 3 months, consistent with what we observed with ZUSDURI. We are aligned with the FDA that the NDA can be submitted with 6-month durability data with plans to update the filing as 12-month durability data become available. Six-month durability data are expected midyear. And if we receive FDA approval in 2027, we expect the permanent J-code could become effective as early as the beginning of 2028. We also see significant opportunity to expand UGN-103 beyond its initial planned indication. We are actively pursuing development in high-grade NMIBC as well as in the adjuvant setting for intermediate risk disease, both of which represent meaningful opportunities to broaden the impact of this program. We plan to hold Type C meetings with the FDA in the second quarter of 2026 to align on the development plans for both studies with the goal of initiating a Phase III trial in high-grade disease before year-end and in the adjuvant intermediate risk setting thereafter. UGN-104, our next-generation program for low-grade upper tract urothelial cancer, continues to progress in a Phase III trial as planned with enrollment expected to complete by the end of 2026. Finally, UGN-501 is our investigational next-generation oncolytic virus therapy being developed as a locally administered treatment for cancer. UGN-501 was specifically designed and genetically engineered to act like chemotherapy initially, producing widespread tumor cell lysis with a subsequent immunomodulatory benefit, which we believe differentiates UGN-501 from other oncolytic viruses in development. IND-enabling studies are nearing completion, and we plan to submit an IND in the second quarter of 2026 and initiate a Phase I clinical trial in NMIBC by year-end. Our nonclinical data support the potential for UGN-501 to be a differentiated oncolytic virus, demonstrating broad and consistent cytotoxic activity across a large panel of bladder cancer cell lines representing a range of tumor stages and grades. These findings reinforce our belief that UGN-501 has the potential to be best-in-class, a highly active, locally delivered therapeutic approach in this setting. The Phase I trial will initially evaluate UGN-501 via aqueous intravesical administration. In parallel, we plan to explore additional modes of delivery, including administration with our proprietary RTGel technology, which may enable prolonged dwell time and enhance local activity. While our initial focus is bladder cancer, we believe this platform has the potential to extend beyond the genitourinary setting into additional tumor types over time. I will now hand it over to Chris to discuss our financial results.

Thank you, Mark. Q1 represents an important step forward as we begin to see the early commercial momentum of ZUSDURI translate into meaningful revenue growth while continuing to manage our cost structure in a disciplined manner. At the same time, we remain focused on supporting the ongoing launch of ZUSDURI, advancing our pipeline and maintaining the financial flexibility needed to execute on our long-term strategy. Now to our financial results. Total revenue was $51 million in the first quarter ended March 31, 2026, compared with $20.3 million in the first quarter of 2025. The 152% year-over-year increase was primarily driven by the commercial launch of ZUSDURI. JELMYTO revenue growth also contributed to the increase. Research and development expenses were $15.6 million in the first quarter of 2026 compared with $19.9 million in the same period in 2025. The decrease in R&D expenses was primarily attributable to the acquisition of UGN-501 in the first quarter of 2025 and ZUSDURI manufacturing costs, which we recognized as R&D expense in the first quarter of 2025 prior to receiving FDA approval. Selling, general and administrative expenses were $51.5 million in the first quarter of 2026 compared with $35 million in the first quarter of 2025. The increase in SG&A expenses was primarily attributable to ZUSDURI commercial activities, including the sales force expansion following ZUSDURI approval and higher brand marketing expenses, an increase in overall commercial operation costs and higher advisory costs, including fees associated with the Pharmakon debt refinancing. We expect Q1 to be the high point of SG&A expense in the year based on phasing of activities and the one-time costs associated with the debt refinancing in the period. Financing expense related to the prepaid forward obligation to RTW Investments was $4.5 million for the first quarter of 2026 compared with $4.6 million in the prior year. Interest expense related to long-term debt was $4.2 million in the first quarter of 2026 compared to $4.1 million in the same period in 2025. The slight increase in interest expense was primarily attributable to the additional borrowings of $75 million in the first quarter of 2026 in connection with the Pharmakon debt refinancing, offset by the lower interest rate. The company reported a net loss of $23.6 million or $0.47 per basic and diluted share in the quarter ended March 31, 2026, compared with a net loss of $43.8 million or $0.92 per basic and diluted share in the first quarter of 2025. As of March 31, 2026, cash, cash equivalents and marketable securities totaled $140.3 million. Finally, turning to guidance. The guidance that we provided on the year-end call in March is unchanged. For the full year 2026, net product revenues for JELMYTO are expected to be in the range of $97 million to $101 million. This implies a year-over-year growth rate of approximately 3% to 7% over 2025. We are not providing formal sales guidance for ZUSDURI in 2026 at this time, given that the product is still in the early stages of its launch. Full year 2026 operating expenses are expected to be in the range of $240 million to $250 million, including noncash share-based compensation expense of $20 million to $24 million. That concludes our prepared remarks. We will now open the call to questions.

Operator

Our first question comes from Tara Bancroft from TD Cowen.

Speaker 5

So congrats on the great quarter. I love to see it. And with this quarter, it appears that you'll pretty significantly exceed the ANKTIVA's demand-driven growth that you previously pointed to as a solid analog for the 6 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?

Tara, thank you. I'm going to ask Chris to comment, and then I'll add any other commentary.

Yes, Tara, thanks for the question. To your point, we pointed to ANKTIVA just to remind folks, when we looked at the first six months with the permanent J-code, they saw a 220% step-up in their revenue. And to your point, given the performance in Q1, we're tracking ahead of that analog. Again, we're not guiding for the year, but I think it's important to reiterate a few points from the call. One, 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. These trends that we're seeing progressed 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.

Yes. Unfortunately, Tara, we don't have a great analog, to be honest. I think as Chris stated, 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 it was in Q1 versus Q4 because of the J-code dynamics, but we do expect to continue to see quarter-over-quarter growth. I wish we could give you an analog. I think we're happy with where we are. We'll continue to see growth and think we're in a good place. But right now, we're not in a good position to provide any additional guidance beyond that.

Operator

Our next question comes from Kelsey Goodwin from Piper Sandler.

Speaker 6

Congrats on the really strong quarter. That's wonderful. Two questions from us. First, could you provide more color on how many TURBTs these patients are receiving prior to getting ZUSDURI? What kind of patients are getting ZUSDURI now? And when patients recur, how do you get ZUSDURI to kind of be that first product that physicians reach for? And then secondly, on reimbursement. Now that the physicians are getting more comfortable post permanent J-code, could you provide some color on what kind of cost sensitivity you're seeing given ZUSDURI is priced relatively lower than some of the high-risk programs at about the $130,000 price range?

Kelsey, great questions. One, I can give you anecdotal information, but we don't track exactly how many TURBTs each patient has had. That information just isn't available. What we're hearing initially is most of the patients treated in the beginning had at least two or three TURBTs. Having said that, we do have physicians that have already adopted ZUSDURI as their standard of care for recurrent patients. We have physicians who have treated several patients into the high teens. So they are really adopting it across the entire paradigm of patients. We will get there, and we want to be very careful — that's one of the things we emphasize with our sales team — that we don't niche ourselves only to those who have had multiple TURBTs. Keeping in mind that 23% have had five or more and 68% have had two or more, even if initial use skewed later line, it's still a large number of patients. Also, recall that in our clinical study many patients had only one or two TURBTs, and we are seeing similar results in clinical practice. Typically in oncology you start with later-line patients and then move up after strong results, and that's where we are. On cost sensitivity, it's an interesting position for us because many comparisons are being made to high-grade therapies, and unfortunately we get lumped in when those discussions occur. We have to continuously remind stakeholders that our price is significantly lower. When we developed our pricing, it was specifically for the low-grade patients and took into consideration the duration of therapy — one reason our price reflects the finite course: six doses and you're done, no maintenance therapy. By contrast, some other therapies involve induction plus ongoing maintenance, in some cases 14-plus doses, which increases the overall cost. We hope that physicians and payers see the value we offer at our price point, and we believe our pricing has been responsible and appropriate for the patient population we're addressing.

Operator

Our next question comes from Amin Makarem from Jefferies.

Speaker 7

Congrats on the quarter. Two from us. First, just following up on the prior question. Can you comment on Q2 demand trends versus Q1 so far, what you're seeing on the field? And whether you're seeing any acceleration early in this quarter? And then the second one, within the new prescribers, how does the mix break down between community versus academic? And are you seeing any meaningful differences in demand across these groups already early in this launch?

Yes. Chris, do you want to comment and then I'll add a few points?

Sure. Thanks for the question. In terms of Q2, it's still early in the quarter, but I would say we are seeing continued demand growth, not necessarily an acceleration, but the trend of month-over-month growth we saw through Q1 has continued into early Q2. In terms of mix, as Liz mentioned on the call, last year roughly 60% of our business was in the hospital setting, and in Q1 we approached a more balanced mix with over 50% in the community setting. That shift toward community is a big part of our growth, and we expect it to continue to move more toward community practices throughout the year. As a reminder, approximately 65% to 70% of these patients are treated in the community setting, so with the J-code in place, opening up those practices is a key driver.

I think it's also important to note that while community is very important, many academic centers that treat a lot of these patients continue to come on board as well. We have some large academic centers that recently had positive formulary decisions. So you'll see new academic centers coming on board as well. It's a continuous process. While most low-grade patients are treated in the community, institutions also drive adoption and are important, particularly for higher-volume accounts and for patients who have had multiple prior treatments.

Operator

Our next question comes from Michael Schmidt from Guggenheim.

Michael Schmidt Analyst — Guggenheim

Congrats on a great first quarter. Maybe just another follow-up on ZUSDURI. Could you comment if you're seeing a change perhaps in the type of patients that are choosing ZUSDURI now over TURBT? I think initially, you spoke about the 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 product has been on the market longer. And then bigger picture, how do you think about the intermediate risk market evolving longer term with the potential entry of adjuvant therapies in the future post TURBT? And how could that impact the landscape as you think about ZUSDURI use long term?

Yes. Michael, I like the phrasing 'patients choosing.' Yes, we are seeing a broader range of patients getting ZUSDURI. Initially, there was a focus on patients who were higher surgical risk or older, but we are starting to see patients request ZUSDURI as awareness grows — comments like 'I want that gel therapy.' One clear differentiator for us versus therapies in the adjuvant setting is that ZUSDURI provides a meaningful clinical result without requiring surgery. Many physicians traditionally favor TURBT followed by adjuvant therapy because of their comfort with surgery, but patients increasingly prefer avoiding another surgery if possible. For example, we recently heard about a patient with multiple close recurrences who received ZUSDURI and had two small lesions fulgurated in the office, avoiding major surgery. As more patients and physicians see those outcomes, we expect ZUSDURI use to expand beyond late-line patients. While adjuvant therapies will exist and some physicians will continue the surgical-first approach, we believe patient preference for nonsurgical options, combined with our clinical durability and finite six-week regimen without maintenance, will drive adoption in the low-grade intermediate risk population. We also believe the market can grow with more entrants and broader awareness, and even with less than 20% penetration, we forecast potential for ZUSDURI to exceed $1 billion in annual revenue given the size of the opportunity.

Operator

Our next question comes from the line of Raghuram Selvaraju from H.C. Wainwright & Co.

Speaker 9

Just three quick ones from us. Firstly, can you give a sense of where you expect the timing between receipt of a patient enrollment form and finalization of reimbursement for ZUSDURI to be by the end of 2026, given the impact of the J-code? Secondly, could you talk a bit further about the community hospital contribution at steady state to the ZUSDURI revenue base on a percentage basis? Any specific nuances between receptivity at the community setting relative to the academic setting? And lastly, could you provide a few words on JELMYTO and what you see as the long-term future for that product and the life cycle management initiative with UGN-104? Can we expect some reacceleration of JELMYTO uptake? Do you think there is incremental gain to be made there? And are you seeing renewed interest in JELMYTO given the receptivity you've seen so far with ZUSDURI among prescribing physicians?

I'll address JELMYTO first. We expect, as I mentioned earlier, continued stable, predictable demand and low single-digit growth for JELMYTO in 2026. We continue to add new users, which reflects sustained confidence among urologists. The challenge for JELMYTO historically is finding the patients — a physician may use it and then not see another eligible patient for several quarters. We expect continued new users of JELMYTO, and ZUSDURI's broader outreach will help raise overall awareness, which can indirectly support JELMYTO adoption. Regarding UGN-104, it will be important to see the data, particularly around stricture rates, given prior perceptions tied to how those were characterized. The nephrostomy tube usage in some clinical contexts may affect that discussion. Given JELMYTO's long-term durability and the similarity of durable results we are seeing with ZUSDURI, we expect JELMYTO to maintain its role and continue modest growth. On community versus hospital, I expect a steady-state split more in the neighborhood of 60% community and 40% hospital, since most low-grade patients are treated in the community. That said, academic institutions remain important as they see higher volumes of complex or multiply recurrent patients and are often early adopters and champions. We have institution physicians who are strong advocates and use ZUSDURI broadly, and they will continue to be a major part of uptake.

Thanks, Ram. From PEF to new patient starts, as we discussed, last year the average was roughly 45 to 60 days. Much of that was driven by operational onboarding and hospital formulary processes rather than benefit verification, which takes only a few days once submitted to the hub. We expect that time to conversion will compress as ZUSDURI is integrated into clinical workflows. We saw that improvement in Q1 — average time to conversion in Q1 was about 30 to 35 days — and we expect ultimately in steady state to be closer to where we are today with JELMYTO, which is about two to three weeks from PEF to new patient start.

Operator

Our last question comes from Paul Choi from Goldman Sachs.

Speaker 10

Let me add my congratulations on the good results. Liz, can you provide some color on where the ZUSDURI uptake is happening? Specifically, what percentage of overlap is there with existing JELMYTO users versus prescribers who are just new and outside your current commercial base or prior commercial base? And my second question for Mark: could you expand on UGN-103 development plans and potentially an adjuvant trial, which seems to be the direction of travel for some competitors? What might that kind of trial look like for UGN-103?

Speaker 3

Thanks, Paul. We are excited about UGN-103's NDA submission this year and an expected approval for the successor molecule to ZUSDURI. In terms of expanding the label into other disease settings, we are finalizing conversations about trial designs for adjuvant therapy in newly diagnosed intermediate risk disease and for trials in high-grade disease. These trial designs anticipate prospective randomized adjuvant therapy with a control arm, and we are finalizing details. We anticipate initiating the high-grade trial this year as currently planned.

On the overlap with JELMYTO users, absolutely we see overlap. Some of our initial ZUSDURI users were JELMYTO users. Today, over 50% of ZUSDURI prescribers are JELMYTO users, which is not surprising given the clinical overlap. Early in the launch that percentage was even higher, approaching 80% among initial adopters, but as we've expanded outreach, the mix now includes more non-JELMYTO prescribers as well. So we're seeing both groups use ZUSDURI.

Operator

We have one last question from Leland Gershell from Oppenheimer.

Leland Gershell Analyst — Oppenheimer

Terrific to see ZUSDURI hitting its stride here. I appreciate the additional launch metrics you provided. It looks like you're making solid progress on activated sites and prescribers. If you could, where are you in the context of your overall rollout plan with respect to goals for those various metrics?

Thanks, Leland. Very early. We are nowhere near where we want to be. Our target is to reach 8,500 doctors and health care providers, and as of now we have around 300 unique prescribers. So we have a long way to go. That's actually good news because it means a large opportunity ahead. We're pleased with the early feedback from physicians who have used ZUSDURI, but we need to continue to add new users. Our strategy focuses on both breadth and depth: adding new prescribers while encouraging deeper utilization among those who already use ZUSDURI. We're still in the very early stages of penetration among physicians.

Operator

I'm showing no further questions. This concludes the question-and-answer session. I would now like to turn it back to Liz Barrett for closing remarks.

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

Operator

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