Q1 2026 UroGen Pharma Ltd Earnings Call

May 6, 2026

Operator: Good day. Thank you for standing by. Welcome to the UroGen Pharma Q1 2026 results earning call. I would now like to hand the conference over to your first speaker today, Vincent Perrone, Senior Director of IR.

Speaker #1: After the speaker's presentation, there will be a question-and-answer session. To ask a question during the session, you will need to press star 11 on your telephone.

Speaker #1: You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 11 again. Please be advised that today's conference call is being recorded.

Speaker #1: I would now like to hand the conference over to your first speaker today, Vincent Perrone, Senior Director of IR.

Speaker #2: 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.

Vincent Perrone: Thank you. Good morning, everyone, welcome to UroGen Pharma's Q1 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 31 March 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.

Speaker #2: The release can be accessed on the investor's 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.

Speaker #2: On today's call, we will be making certain forward-looking statements. These may include statements regarding our ongoing commercialization activities related to Zesturi and Gelmido, our ongoing and planned clinical trials and non-clinical trials, commercial and clinical development milestones, market and revenue opportunities, our commercialization strategy and expectations, as well as anticipated data regulatory filings and decisions, the importance of Zesturi'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.

Vincent Perrone: These may include statements regarding our ongoing commercialization activities related to ZUSDURI and JELMYTO, our ongoing and planned clinical trials and non-clinical trials, commercial and clinical development milestones, market and revenue opportunities, our commercialization strategy and expectations, as well as anticipated data, regulatory filings and decisions, the importance of ZUSDURI's growth for UroGen's long-term strategy, the potential benefits of our products and product candidates, future R&D efforts and milestones, our corporate goals, and 2026 financial guidance, among other things. These forward-looking statements are based on current information, assumptions, and expectations that are subject to change. A description of potential risks can be found in our earnings press release and latest SEC disclosure documents. You are cautioned not to place undue reliance on these forward-looking statements, and UroGen disclaims any obligation to update these statements. I'll now turn the call over to Liz.

Speaker #2: 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.

Speaker #2: 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 #3: 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 Zesturi launch, the board and I made the decision a few months ago that I would assume direct oversight of the commercial organization.

Liz Barrett: 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. 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 Q1, highlighted by $29.2 million in ZUSDURI revenue. This represents more than 100% quarter-over-quarter growth.

Speaker #3: 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.

Speaker #3: Now turning to our results, we are very pleased by our performance in the first quarter. Highlighted by 29.2 million dollars in Zesturi revenue. This represents more than 100% quarter-over-quarter growth.

Speaker #3: 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.

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

Speaker #3: 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.

Speaker #3: This progress reflects the differentiated value Zesturi brings to patients and physicians. As the first and only FDA-approved medicine for adults with recurrent low-grade intermediate risk non-muscle invasive bladder cancer, Zesturi offers a non-surgical treatment in a disease historically managed through repeated surgical intervention.

Speaker #3: Zesturi'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.

Speaker #3: 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.

Liz Barrett: 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 Q1, we had 256 unique prescribers, up from 102 at year-end, and 103 repeat prescribers, up from 32. This is the most important indicators we track as it reflects growing HCP confidence and successful integration of ZUSDURI into routine urology practice. Importantly, these growth trends were consistent throughout the quarter and not limited to the immediate period following the implementation of the J-code. This gives us confidence in the durability of the launch and supports our expectation for continued growth as we move through Q2 and the rest of the year.

Speaker #3: And 103 repeat prescribers, up from 32. This is the most important indicators we track as it reflects growing HCP confidence and successful integration of Zesturi into routine urology practice.

Speaker #3: 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.

Speaker #3: 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.

Liz Barrett: Patient enrollment forms, or PEFs, remain an important early indicator of demand, providing visibility into activity at the top of the funnel before it is reflected in new patient starts and revenue. In Q1, we saw continued sequential growth in PEF volume, which we believe reflects strong and expanded healthcare provider engagement. As we've shared, PEFs, new patient starts, and doses all significantly outpaced JELMYTO in Q1, and we expect continued growth across all measures over the course of the year. In terms of conversion, the cycle time from PEFs 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 continue 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.

Speaker #3: In Q1, we saw continued sequential growth in PEF volume, which we believe reflects strong and expanded healthcare provider engagement. As we've shared, PEFs, new patient starts, and doses all significantly outpaced Gelmido in Q1.

Speaker #3: And we expect continued growth across all measures over the course of the year. In terms of conversion, the cycle time from PEFs to treatment initiation was approximately 45 to 60 days in Q4, which was expected as sites worked through onboarding and workflow integration.

Speaker #3: In Q1, we continue to see improvement and expect this to continue over the course of the year, moving toward the two to three-week range.

Speaker #3: We see today with Gelmido. We also see a continued shift toward greater utilization in community practices. In Q4, the mix was approximately 60% hospital and 40% community.

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

Speaker #3: 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 Zestori.

Speaker #3: From an access and reimbursement perspective, we have open access across more than 95% of covered lives, and reimbursement confidence has significantly improved amongst practices, with a permanent J-code for Zesturi becoming effective on January 1st, 2026.

Speaker #3: 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.

Speaker #3: Our focus remains on expanding adoption in the community setting, driving depth of utilization in accounts who have used Zestori, and continuing to improve patient conversion timelines.

Liz Barrett: Our focus remains on expanding adoption in the community setting, driving depth of utilization in accounts who have used ZUSDURI, and continue to improve patient conversion timelines. In parallel, we are beginning to expand our commercial approach to more directly engage patients, including targeted awareness efforts, as we believe patients can be a key catalyst to drive adoption, and ZUSDURI is in a unique position of providing both recurrence and treatment-free living. ZUSDURI addresses an estimated $5 billion annual market opportunity in recurrent low-grade intermediate-risk non-muscle invasive bladder cancer, and we believe its differentiated clinical profile positions it to capturing 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.

Speaker #3: In parallel, we are beginning to expand our commercial approach to more directly engage patients including targeted awareness efforts as we believe patients could be a key catalyst to drive adoption in Zesturi is in a unique position of providing both recurrence and treatment-free living.

Speaker #3: Zesturi 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.

Speaker #3: As adoption continues to build, we see Zesturi as a foundational treatment for adults with recurrent low-grade intermediate risk non-muscle invasive bladder cancer patients with a potential to evolve into a blockbuster therapy with peak annual revenues exceeding $1 billion.

Liz Barrett: Turning to JELMYTO, we reported revenue of $21.7 million in Q1 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 H2 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.

Speaker #3: Turning to Gelmido, 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.

Speaker #3: We continue to advance our pipeline, including UGN 103, our next generation mitomycin-based intravascular therapy, where we will have established a clear regulatory pathway for adults with recurrent low-grade intermediate risk non-muscle invasive bladder cancer, we remain on track for our NDA submission in the second half of 2026, with potential approval in 2027.

Speaker #3: We also plan to expand this product into additional bladder cancer settings as part of our broader lifecycle strategy. More broadly, as leaders in neurooncology, we believe that non-muscle invasive bladder cancer patients need options.

Liz Barrett: 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. We have a strong balance sheet with approximately $140 million in cash equivalents, and marketable securities as of 31 March, 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. 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.

Speaker #3: 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.

Speaker #3: Finally, we have a strong balance sheet with approximately $140 million in cash, cash equivalents, and marketable securities as of March 31st. Supported by the refinancing of our term loan with Pharmacon Advisors during the quarter.

Speaker #3: This provides us with the flexibility to fully support the ongoing launch of Zesturi while continuing to invest in our next generation pipeline with cash runway two and three profitability.

Speaker #3: 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.

Speaker #3: I will now turn the call over to Mark for a clinical update. Mark?

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

Speaker #1: Thank you, Liz. The American Urologic Association annual meeting will take place May 15th to 18th in Washington, DC. UroGen will have a significant presence there and we believe this is an important opportunity to engage with both community and academic urologists and further discuss the clinical value of Zesturi and Gelmido.

Mark Schoenberg: Thank you, Liz. The American Urological Association annual meeting will take place 15 May to 18 May in Washington, DC. UroGen will have a significant presence there. We believe this is an important opportunity to engage with both community and academic urologists and further discuss the clinical value of ZUSDURI and JELMYTO. For UroGen, the national AUA meeting represents a highly relevant and meaningful forum to continue building awareness and healthcare provider engagement. Bladder cancer will be a central focus of this year's meeting. 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.

Speaker #1: For UroGen, the National AUA meeting represents a highly relevant and meaningful forum to continue building awareness and healthcare provider engagement. Bladder cancer will be a central focus of this year's meeting and it's important to clearly within the evolving treatment landscape for NMIBC.

Speaker #1: 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.

Speaker #1: 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.

Mark Schoenberg: 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 3 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.

Speaker #1: Zesturi was specifically designed to address this need. Its clinical benefit is driven by both its efficacy and mode of administration. In the phase three envision trial, which supported its FDA approval, Zesturi demonstrated a robust complete response rate of approximately 80% at three months, an importantly durable outcomes over time.

Speaker #1: 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.

Mark Schoenberg: Importantly, median duration of response has not been reached in the ENVISION study at a median follow-up of 23.7 months after a 3-month complete response. From a clinical perspective, this level of durability is meaningful, as it has the potential to interrupt the cycle of recurrences and decreases patients' treatment burden. In practical terms, it translates into longer recurrence-free intervals and extended periods without treatment. Equally important is how ZUSDURI is delivered. It is administered as a finite 6-dose chemoablative regimen in the outpatient setting without the need for surgery or ongoing maintenance therapy. In our experience, this allows for straightforward integration into routine clinical practice without significant changes to workflow or infrastructure. This approach is distinct from many therapies currently in development, which are typically evaluated in the adjuvant setting and administered following TURBT.

Speaker #1: Importantly, median duration of response has not been reached in the envision study at a median follow-up of 23.7 months after three-month complete response. From a clinical perspective, this level of durability is meaningful as it has the potential to interrupt the cycle of recurrences and decreases patients' treatment burden.

Speaker #1: In practical terms, it translates into longer recurrence-free intervals and extended periods without treatment. Equally important is how Zesturi is delivered. It is administered as a finite, six-dose chemoablative regimen in the outpatient setting, without the need for surgery or ongoing maintenance therapy.

Speaker #1: 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.

Speaker #1: And administered following TURBT. These regimens often involve induction and maintenance therapy over extended periods, in some cases up to one year. Zesturi, by contrast, is designed as a primary nonsurgical therapy with a total treatment duration of six weeks.

Mark Schoenberg: These regimens often involve induction and maintenance therapy over extended periods, in some cases up to 1 year. ZUSDURI, by contrast, is designed as a primary non-surgical therapy with a total treatment duration of 6 weeks. Taken together, this approach represents a meaningful shift in how this disease can be managed, offering durable disease control with a finite course of therapy while reducing treatment burden and enabling extended recurrence-free and treatment-free living. As we continue to gain real-world experience, understanding how these clinical benefits translate into routine practice is increasingly important. At the upcoming AUA annual meeting, UroGen will host a KOL panel focused on real-world experience with ZUSDURI, including patient selection, workflow integration, treatment patterns, and patient outcomes. This event will be webcast and accessible through the company's website, and we believe it will provide important clinical perspective on how ZUSDURI is being incorporated into routine practice.

Speaker #1: Taken together, this approach represents a meaningful shift in how this disease can be managed offering durable disease control with a finite course of therapy while reducing treatment burden and enabling extended recurrence-free and treatment-free living.

Speaker #1: 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 the KOL panel focused on real-world experience with Zesturi.

Speaker #1: 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 Zesturi is being incorporated into routine practice.

Speaker #1: 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 Zesturi.

Mark Schoenberg: 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 2041. We plan to submit an NDA for UGN-103 in the H2 of this year based on results from the Phase 3 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.

Speaker #1: 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.

Speaker #1: We plan to submit an NDA for UGN 103 in the second half of this year based on results from the phase three Utopia trial.

Speaker #1: Which demonstrated a 77.8% complete response rate at three months, consistent with what we observed with Zesturi. We are aligned with the FDA that the NDA can be submitted with six months' durability data, with plans to update the filing as 12-month durability data become available.

Mark Schoenberg: Six-month durability data are expected mid-year, and if we receive FDA approval in 2027, we expect the permanent J-code could become effective as early as the beginning of 2028. We also see significant opportunity to expand UGN-103 beyond its initial planned indication. We are actively pursuing development in high-grade NMIBC, as well as in the adjuvant setting for intermediate-risk disease, both of which represent meaningful opportunities to broaden the impact of this program. We plan to hold Type C meetings with the FDA in Q2 2026 to align on the development plans for both studies, with the goal of initiating a Phase 3 trial in high-grade disease before year-end, and in the adjuvant intermediate-risk setting thereafter.

Speaker #1: Six-month durability data are expected mid-year. And if we receive FDA approval in 2027, we expect the permanent J code could become effective as early as the beginning of 2028.

Speaker #1: 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.

Speaker #1: Both of which represent meaningful opportunities to broaden the impact of this program. We plan to hold type C meetings with the FDA in the second quarter of 2026 to align on the development plans for both studies with the goal of initiating a phase three trial in high-grade disease before year-end and in the adjuvant intermediate risk setting thereafter.

Speaker #1: UGN-104, our next-generation program for low-grade upper tract urothelial cancer, continues to progress in a Phase 3 trial as planned, with enrollment expected to complete by the end of 2026.

Mark Schoenberg: UGN-104, our next-generation program for low-grade Upper Tract Urothelial Cancer, continues to progress in a Phase 3 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 Q2 2026 and initiate a Phase 1 clinical trial in NMIBC by year-end. Our non-clinical 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.

Speaker #1: 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.

Speaker #1: 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 one clinical trial in NMIBC by year-end.

Speaker #1: Our non-clinical 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.

Speaker #1: These findings reinforce our belief that UGN 501 has the potential to be best in class, highly active, locally delivered therapeutic approach in this setting.

Mark Schoenberg: These findings reinforce our belief that UGN-501 has the potential to be best-in-class, highly active, locally delivered therapeutic approach in this setting. The Phase I trial will initially evaluate UGN-501 via aqueous intravesical administration. In parallel, we plan to explore additional modes of delivery, including an administration with our proprietary RTGel technology, which may enable prolonged dwell time and enhanced local activity. While our initial focus is bladder cancer, we believe this platform has the potential to extend beyond the genitourinary setting into additional tumor types over time. I will now hand it over to Chris to discuss our financial results.

Speaker #1: The phase one 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 RT gel technology.

Speaker #1: Which may enable prolonged dwell time and enhanced local activity. While our initial focus is bladder cancer, we believe this platform has the potential to extend beyond the genitourinary setting into additional tumor types over time.

Speaker #1: I will now hand it over to Chris to discuss our financial results.

Speaker #2: Thank you, Mark. Q1 represents an important step forward. As we begin to see the early commercial momentum of Zesturi, translate into meaningful revenue growth while continuing to manage our cost structure in a disciplined manner.

Chris Degnan: 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 Q1 ended 31 March 2026, compared with $20.3 million in Q1 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.

Speaker #2: At the same time, we remain focused on supporting the ongoing launch of Zesturi, advancing our pipeline, and maintaining the financial flexibility needed to execute on our long-term strategy.

Speaker #2: Now to our financial results. Total revenue was $51 million, in the first quarter ended March 31st, 2026. Compared with $20.3 million, in the first quarter of 2025.

Speaker #2: The $152% year-over-year increase was primarily driven by the commercial launch of Zesturi. Angel Mito revenue growth also contributed to the increase. Research and development expenses were $15.6 million, in the first quarter of 2026.

Chris Degnan: Research and development expenses were $15.6 million in Q1 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 Q1 2025 and ZUSDURI manufacturing costs, which we recognized as R&D expense in Q1 2025 prior to receiving FDA approval. Selling, general, and administrative expenses were $51.5 million in Q1 2026, compared with $35 million in Q1 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.

Speaker #2: 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.

Speaker #2: And Zesturi 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.

Speaker #2: Compared with $35 million, in the first quarter of 2025. The increase in SGNA expenses was primarily attributable to Zesturi commercial activities. Including the Salesforce expansion following Zesturi approval and higher brand marketing expenses, an increase in overall commercial operation costs, and higher advisory costs, including fees associated with the pharmacon debt refinancing.

Speaker #2: We expect Q1 to be the high point of SGNA expense in the year, based on phasing of activities, and the one-time costs associated with the debt refinancing in the period.

Chris Degnan: 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 Q1 2026, compared with $4.6 million in the prior year. Interest expense related to long-term debt was $4.2 million in Q1 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 Q1 2026 in connection with the Pharmakon debt refinancing, offset by the lower interest rate.

Speaker #2: 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.

Speaker #2: 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.

Speaker #2: The slight increase in interest expense was primarily attributable to the additional borrowings of $75 million, in the first quarter of 2026. In connection with the pharmacon debt refinancing, offset by the lower interest rate.

Speaker #2: The company reported a net loss of $23.6 million, for $47 cents per basic and diluted share, in the quarter ended March 31st, 2026. Compared with a net loss of $43.8 million, for $92 cents per basic and diluted share, in the first quarter of 2025.

Chris Degnan: The company reported a net loss of $23.6 million, or $0.47 per basic and diluted share in the quarter ended 31 March 2026, compared with a net loss of $43.8 million, or $0.92 per basic and diluted share in Q1 2025. As of 31 March 2026, cash equivalents, and marketable securities totaled $140.3 million. Finally, turning to guidance. The guidance that we provided on the year-end call in March is unchanged. For the full year 2026, net product revenues for JELMYTO are expected to be in the range of $97 to 101 million. This implies a year-over-year growth rate of approximately 3% to 7% over 2025.

Speaker #2: As of March 31st, 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.

Speaker #2: For the full year 2026, net product revenues for Joe Mito are expected to be in the range of $97 to $101 million. This implies a year-over-year growth rate of approximately 3 to 7 percent over 2025.

Speaker #2: We are not providing formal sales guidance for Zesturi in 2026 at this time, given that the product is still in the early stages of its launch.

Chris Degnan: 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 to 250 million, including non-cash share-based compensation expense of $20 to 24 million. That concludes our prepared remarks. We will now open the call to questions.

Speaker #2: Full year 2026 operating expenses are expected to be in the range of $240 to $250 million. Including non-cash, share-based compensation expense, of $20 to $24 million.

Speaker #2: That concludes our prepared remarks. We will now open the call to questions.

Speaker #3: Thank you. At this time, we will conduct the question-and-answer session. As a reminder, to ask a question, you will need to press star 1-1 on your telephone and wait for your name to be announced.

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

Speaker #3: To withdraw your question, please press star 11 again. Please stand by while we compile the Q&A roster. Our first question comes from Tara Bancroft, from TD Cohen.

Speaker #3: Tara, the line is open.

Tara Bancroft: Hi. Good morning. Congrats on the great quarter. Love to see it. You know, with this quarter, it appears that you'll pretty significantly exceed the ANKTIVA's demand-driven growth that you previously pointed to as a solid analog for, you know, those 6 months post the permanent J-code. I'm wondering if you have any updated thoughts on how we should think about growth for the rest of the year from here, and maybe is there any other analog that we should look to instead from here? Thanks.

Speaker #4: Hi, good morning. So congrats on the great quarter. Love to see it. And with this quarter, it appears that you'll pretty significantly exceed the Antiva's demand-driven growth that you previously pointed to as a solid analog for those six months post the permanent J code.

Speaker #4: 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?

Speaker #4: Thanks.

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

Speaker #5: Hi, Tara. Thank you. I'm going to ask Chris to comment, and then I'll add any other commentary.

Speaker #2: Yeah, Tara, thanks for the question. To your point, I mean, we pointed to Antiva just to reground folks when we looked at the first six months with the permanent J code.

Chris Degnan: Yeah, Tara, thanks for the question. To your point, I mean, we pointed to ANKTIVA, just to reground folks, when we looked at the first 6 months with the permanent J-code. You know, they saw a 220% step-up in their revenue. To your point, you know, given the performance in Q1, you know, we're tracking ahead of that analog. Again, we're not guiding for the year, I mean, I think it's important to reiterate a few points from the call. One, that we're seeing, you know, consistent growth across all our commercial indicators. This wasn't a one-time step-up with the J-code that we saw in January.

Speaker #2: 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.

Speaker #2: One that we're seeing consistent growth across all our commercial indicators. This wasn't a one-time step up with the J code that we saw in January.

Speaker #2: So these trends that we're seeing are progressing consistently throughout the quarter and into Q2, which gives us confidence that the underlying demand is building in a sustainable way.

Chris Degnan: These trends that we're seeing are progressing consistently throughout the quarter and into Q2, which gives us confidence that, you know, the underlying demand is building in a sustainable way. And as Liz mentioned on the call, we do expect, you know, continued growth in Q2 and throughout the year, given the early stages of the launch.

Speaker #2: 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.

Speaker #5: Yeah, so unfortunately, Tara, we don't have a great analog, to be honest with you. That we could share with you. I think as Chris stated, I think we feel good about where we are.

Liz Barrett: Yeah. Unfortunately, Tara, we don't have a great analog, to be honest with you know, that we could share with you. I think, you know, as Chris stated, you know, I think we feel good about, you know, where we are

Liz Barrett: You know, we expect to continue to grow. We do want to caution everybody that, you know, quarter-over-quarter growth is not likely to be the same, you know, as we go forward as it was in the Q1 versus Q4 because of the J-code dynamics. We do expect to continue to see quarter-over-quarter growth. I wish we could give you an analog. I think, you know, we're happy with where we are. We'll continue to see growth and, you know, think we're in a good place. Right now we're just not in a good position to provide any additional guidance beyond that.

Speaker #5: We expect to continue to grow, do want to caution everybody that quarter over quarter growth is not likely to be the same as we go forward as it was in the Q1 versus Q4, because of the J code dynamics.

Speaker #5: But we do expect to continue to see quarter over quarter growth. So I wish we could give you an analog. I think we're happy with where we are.

Speaker #5: We'll continue to see growth, and think we're in a good place. But right now, we're just not in a good position to provide any additional guidance beyond that.

Speaker #4: Okay, great. Yeah, understand completely. Thanks so much for that.

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

Speaker #5: Thanks. Appreciate it.

Liz Barrett: Thanks. Appreciate it.

Speaker #3: Thank you. One moment for our next question. Our next question comes from Kelsey Goodwin from Piper Sandler. Kelsey, the line is now open.

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

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

Speaker #4: Oh, perfect. Hey, thanks so much for taking our questions and congrats on the really strong quarter. That's wonderful, Liz. Two questions from us. First, could you provide more color on how many TURBTs these patients are receiving prior to getting Zesturi?

Speaker #4: What kind of patients are getting Zesturi now, and when patients recur? How do you get Zesturi to kind of be that first product that physicians reach for?

Speaker #4: And then secondly, on reimbursement. Now that physicians are getting more comfortable post-permanent J code, I guess maybe could you provide some color on what kind of cost sensitivity you're seeing, given Zesturi's priced relatively lower than some of the high-risk programs at about $130K price range?

Speaker #4: Thanks so much.

Speaker #5: Yeah, hi, Kelsey. Great but we don't track, obviously, how many TURBTs. That information just isn't available. What we're hearing in the beginning is most of the patients that are getting treated in the beginning are those that have had at least two or three TURBTs.

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

Speaker #5: Having said that, we do have physicians that have already adopted Zesturi as sort of their standard of care. And so for a recurrent patient.

Speaker #5: And what I mean by that is they're looking we do have physicians who have treated several patients into the high teens. And so they are really adopting it across the entire paradigm of patients.

Speaker #5: So I think we will get there, and we want to be very careful. And that's one of the things we also are very careful with ourselves team is that we don't niche ourselves into those that have had multiple TURBTs.

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

Speaker #5: Keeping in mind that 23% have had five or more, and 68% have had two or more. So even if we did have those patients, it's still a large number of patients, but we want to make sure that everybody understands and particularly if you look at our clinical study, a lot of those patients only had one or two.

Speaker #5: And so we are seeing, again, but initially, it's the expectation, and this happens across all of oncology. You typically start with your later-line patients, and then move up after they see good results.

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

Speaker #5: So that's kind of where we are with that. On the cost sensitivity, it's kind of an interesting position for us to be in because, obviously, the ones that you're talking about are all high grade.

Speaker #5: And so it’s hard to, but we do get lumped in, unfortunately, with it when they talk about a high-priced drug. They are lumping us in there.

Speaker #5: So we have to continuously remind everybody to your point that our price is significantly less. And we also want to bring that awareness as those high-priced drugs start to move into the low-grade space.

Speaker #5: When we developed our pricing, it was specifically for the low-grade patient. And also, take into consideration the duration of therapy. Because one of the reasons that ours is $130,000 is because you only have six doses, and you're done.

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

Speaker #5: You don't need to continue maintenance. Whereas you look at the other players in the market, both for high-grade and those coming into IR, they have maintenance therapy.

Speaker #5: So you're talking about six doses versus 14-plus doses. That also increases the price. So we hope that not only that physicians, payers, see the value and the value price that we have.

Speaker #5: And I think we've been very responsible from that standpoint for the patient population that we're talking about.

Kelsey Goodwin: Perfect. Super helpful. Thanks so much, and congrats again.

Speaker #4: Perfect. Super helpful. Thanks so much. And congrats again.

Speaker #5: Thanks. Appreciate it, Kelsey.

Liz Barrett: Thanks. Appreciate it, Kelsey.

Speaker #3: Thank you. One moment for our next question. Our next question comes from Amin Mokadrim from Jefferies.

Operator: Thank you. One moment for our next question. Our next question comes from Amin Makarem from Jefferies.

Amin Makarem: Hi. Thank you for taking our questions. Congrats on the quarter. Two from us. First, just following up on a 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 earlier, early in this quarter? Then the second one, within the new prescribers, how does the mix break down between community versus academics? Are you seeing a meaningful differences in demand across these groups already early in this launch?

Speaker #6: Hi. Thank you for taking our questions. And congrats on the quarter. Two from us. First, just following up on the prior question, can you comment on two acute demand trends versus one acute so far, what you're seeing on the field?

Speaker #6: And whether you're seeing any acceleration, earlier in this quarter, and the second one, within the new prescribers, how does the mix break down between community versus academics and are you seeing a meaningful differences in demand across these groups already early in this launch?

Liz Barrett: Yeah. Chris, you wanna comment and then.

Speaker #5: Yeah, Chris, you want to comment, and then I'll.

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

Speaker #7: Sure. I mean, thanks for the question. So, in terms of Q2—I mean, obviously, early stages of Q2—but I would say, not necessarily acceleration, but just continued demand growth.

Speaker #7: As I said, we saw continued growth month over month through Q1. And I would say that trend continues in the early stages of Q2.

Speaker #7: And in terms of mix, as Liz mentioned on the call, 60% of our business was in the hospital setting last year. And we've already now exceeded 50% mix in the community setting.

Speaker #7: In Q1. And so that is a big part of our growth. And we expect that to continue to shift more and more towards the community practices throughout the course of the year.

Speaker #7: And just a reminder, 65, 70 percent of these patients are treated in the community setting. So that's a big piece with the J code being in place and opening up those practices for us.

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

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

Speaker #5: Yeah, I think it's also just important to note that community is very important, but also a lot of the academic centers who do have a lot of these patients, they also continue to come on board.

Speaker #5: So we have some large academic centers that we've just received in the last month. The formulary positive formulary decision. So you'll see some new academic centers coming on board as well.

Speaker #5: So it's a continuous thing, but obviously, most of those patients low-grade patients do get treated in a community. So as we grow community, but also important that we also support the institutions as they are a big driver also of the adoption.

Speaker #5: But thanks for your questions.

Chris Degnan: Thanks.

Amin Makarem: Thanks.

Speaker #6: Thanks.

Speaker #3: Thank you. One moment for our next question. Our next question comes from Michael Schmidt from Guggenheim. Michael, the line is now open.

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

Speaker #8: Oh, hey, guys. Good morning. Thanks for taking my question and congrats on a great first quarter. Yeah, maybe just another follow-up on Zesduri. Could you just comment if you're seeing a change perhaps in the type of patients that are choosing Zesduri now over TURBT?

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

Speaker #8: I think initially you spoke about preference by patients who are high-risk surgery, high-risk, or elderly-type patients. I'm just curious if that's shifting a bit now that the product has been on the market longer.

Speaker #8: And then maybe bigger picture, how do you think about the intermediate risk market evolving longer term with the potential entry of adjuvant therapies in the future, post-TURBT?

Speaker #8: And how could that impact the landscape as you think about Zesduri use long term? Thank you.

Speaker #5: Yeah, no, great, Michael. I loved the word when you said, quote-unquote, 'patients choosing.' I will say that, yes, we are seeing across the board different types of patients being able to get Zesduri.

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

Speaker #5: I think you’re— and your comment about that, I will also say, I’ll also answer as part of your second question. What we are finding and what we're hearing— and this is anecdotal, right?

Speaker #5: So I just want to be very careful about that, is we are starting to see and hear about patients requesting Zesduri. We're hearing things like, "Oh, I want that gel stuff." And so patients, as they're starting to hear more about that, one of the ways that we believe we can clearly differentiate ourselves versus the market as the market evolves, is given that we are the treatment that does not have surgery, yet we have very meaningful clinical results.

Liz Barrett: You know, we're hearing things like, Oh, I want that gel stuff. Patients, as they're starting to hear more about that, one of the ways that we believe we can clearly differentiate ourselves versus the market as the market evolves, is given that we are the treatment that does not have surgery, yet we have very meaningful clinical results. When you talk to patients, they don't want another surgery.

Speaker #5: And so when you talk to patients, they don't want another surgery. So while the adjuvant setting, I believe that you'll always have those physicians who want to do surgery because it's in their nature to cut it out.

Liz Barrett: While at the adjuvant setting, I believe that you'll always have those physicians who want to do surgery because they, you know, it's just, it's in their nature to cut it out and then come back with another therapy. I think you're gonna see that patients are gonna be opposed to that, and patients are gonna want to say, Hey, let me see how this one works without surgery, because you can, you know, go back and have surgery. I'll give you an example. We just heard about a patient who had multiple recurrences and very close together, used ZUSDURI, and she did have two small lesions, which were able to be fulgurated in the office.

Speaker #5: And then come back with another therapy. I think you're going to see that patients are going to be opposed to that. And patients are going to want to say, "Hey, let me see how this one works without surgery," because you can go back and have surgery.

Speaker #5: I'll give you an example. We just heard about a patient who had multiple recurrences, and very close together, used Zesduri and she did have two small lesions which were able to be fulgurated in the office.

Speaker #5: So I think more and more as you start to hear about that, then I think our drug will get used less in adjuvant. It does get used.

Liz Barrett: I think more and more as you start to hear about that, then I think the our drug will get used less in adjuvant. It does get used. We do know of physicians that are even using ZUSDURI right now after surgery. Again, one of the biggest benefits we can provide and why we believe we will be the patient's choice for a treatment is because not only do you not have to have surgery, but you also don't have to have maintenance therapy. That it's a clear differentiator for us. Given the results, you have to look at the complete response and the durability that we have without surgery. You know, to your point, I think it will continue to evolve. I think there'll be opportunity for others in this space.

Speaker #5: We do know a physicians that are even using Zesduri right now after surgery. But again, one of the biggest benefits we can provide and why we believe we will be the patient's choice for treatment is because not only do you not have to have surgery, but you also don't have to have maintenance therapy.

Speaker #5: So it's a clear differentiator for us. And given the results, you have to look at the complete response and the durability that we have without surgery.

Speaker #5: So, to your point, I think it will continue to evolve. I think there'll be opportunity for others in the space. I think more companies and more drugs being introduced will help to grow the market.

Liz Barrett: I think more companies and more drugs being introduced will help to grow the market. You know, as we've talked about before, even given our, you know, the pricing of our medicine and the use of only 6 weekly doses, we still believe that we'll have over a billion-dollar revenue drug with only less than a 20% market penetration. Think there's plenty of room for the category and for the area to evolve, but I also believe that we have a clear differentiator versus anyone coming in. Especially even today when there's no one coming in the, you know, in the near future. It's gonna be a couple of years before there's others coming in.

Speaker #5: And as we've talked about before, even given our the pricing of our medicine and the use of only six-weekly doses, we still believe that we'll have over a billion dollar revenue drug with only less than a 20% market penetration.

Speaker #5: So I think there's plenty of room for the category and for the area to evolve. But I also believe that we have a clear differentiator versus anyone coming in, and especially even today, there's no one coming in in the near future.

Speaker #5: So it's going to be a couple of years before there's others coming in. But our ability to offer patients an opportunity to not go through surgery but still get very meaningful results is very critical.

Liz Barrett: Our ability to offer patients an opportunity to not go through surgery but still get very meaningful results is very critical.

Speaker #3: Thank you. One moment for our next question. Our next question comes from the line of Roguram Selvuraju. From HC Wainwright & Co.

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

Speaker #6: Thanks very much for taking my questions just three quick ones from us. Firstly, I was wondering if you could give us a sense of where you expect the timing between receipt of a patient enrollment form and finalization of reimbursement for Zesduri to be by the end of 2026, given the impact of the J code.

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

Speaker #6: Secondly, I was wondering if you could talk a little bit further about the community hospital contribution at steady state to the Zesduri revenue base, just on a percentage basis, and also if there are any specific nuances between what you see as the receptivity at the community setting relative to the academic setting, and then lastly, I was wondering if you could just provide us with a few words on Gelmido and what you see as the long-term future for that product as well as the life cycle management initiative with 104.

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

Speaker #6: Can we expect some re-acceleration of Gelmido uptake? Do you think that there is some incremental gain to be made on that front with that product?

Speaker #6: And perhaps most importantly, are you seeing some renewed interest in Gelmido, given the receptivity you've seen so far with Zesduri among prescribing physicians? Thank you.

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

Speaker #5: Yeah, I'm going to actually go backwards if that's okay, Ram. And then I'll leave the last question for which is your first question, and I'll turn it over to Chris.

Speaker #5: On Gelmido, we expect as I mentioned in the remarks to continue to see this sort of predictable growth where we are. So we will continue to see low single-digit growth.

Speaker #5: That's what we've been talking about. The good news is that we do see continue to see new users of Gelmido. The issue for Gelmido always comes around finding the patients.

Speaker #5: So as we go out and talk about Zesduri, even before Zesduri may be on formulary, there are hearing about Gelmido we're getting new users using Gelmido.

Speaker #5: So every quarter, we have new physicians using Gelmido. So we expect that to continue. And again, the challenge there is really where the patient presents.

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

Speaker #5: So you may have a doctor this quarter, and that doctor won't see another Gelmido patient for two, three, four quarters. And so a lot of that so while we expect to continue the slow single-digit growth, we also do expect there to be continued new users of Gelmido.

Speaker #5: And I think Zesduri will help with that. And we've talked about that before. With UGN-104 coming in, it will be interesting to see the data with UGN-104.

Speaker #5: And the only reason I say that is because if you recall, the stricter rate for Gelmido was high because of the way that the FDA required that we characterize that.

Speaker #5: And so we had some physicians who see that and get a little bit worried about that. But now that the nephrostomy tube is at least half of the usage and the clinical study we'll have to see how that comes out in the clinical study.

Liz Barrett: We had some, you know, some physicians who see that and get a little bit worried about that. Now that the nephrostomy tube is at least half of the usage and the clinical study, you know, we'll have to see how that comes out, you know, in the clinical study. Also given the long-term durability of JELMYTO, and we're seeing, you know, very similar results with ZUSDURI. I think all of those things, you know, point to our ability to continue to grow the low single digits for JELMYTO. So, you know, and the fact that we'll continue to grow the number of doctors that we're calling on with ZUSDURI, and that will also help JELMYTO.

Speaker #5: And also, given the long-term durability of Gelmido, and we're seeing very similar results with Zesduri, I think all of those things point to our ability to continue to grow in the low single digits for Gelmido.

Speaker #5: So and the fact that we'll continue to grow the number of doctors that we're calling on with Zesduri, and that will also help Gelmido.

Speaker #5: On the community end up, my guess is going to be more of a 60/40 situation where most of it's coming from the community because that's just where the patients get seen.

Liz Barrett: On the community versus a hospital, where we end up, you know, my guess is gonna be more of a 60/40 situation where most of it's coming from the community because that's just where the patients get seen. I mean, that's reality. Having said that, I don't want to negate the fact that the institutions are very important, and that's a lot of that is because once these patients have been, you know, treated multiple times, they tend to be sent to, you know, an institution or an academic institution. We also know that they tend to be high volume, you know, high volume accounts. While we expect ultimately, you know, the community bigger, the institutions will always be a major part of ZUSDURI.

Speaker #5: I mean, that's reality. Having said that, I don't want to negate the fact that the institutions are very important. And that's a lot of that is because once these patients have been treated multiple times, they tend to be sent to an institution or an academic institution.

Speaker #5: And we also know that they tend to be high-volume accounts. And so while we expect ultimately the community to be bigger, we the institutions will always be a major part of Zesduri.

Liz Barrett: We have some, you know, some institution physicians who have already become real champions and advocates of ZUSDURI, and as I mentioned before, using it on most of their patients. They're seeing, and I'm sure you heard last week with Dr. Chamie, you know, he's seeing more patients than he frankly thought he would that are appropriate for ZUSDURI. I think we're hearing that more and more. I think that's where we'll end up. Then I'll just ask Chris to talk a little bit about the conversion timing and where we expect it to be by end of 2026. Chris.

Speaker #5: And we have some institution physicians who have already become real champions and advocates of Zesduri. And as I mentioned before, using it on most of their patients.

Speaker #5: And they're seeing and I'm sure you heard last week with Dr. Chamey, he's seeing more patients than he frankly thought he would in this that are appropriate for Zesduri.

Speaker #5: And I think we're hearing that more and more. So I think that's where we'll end up. And then I'll just ask Chris to talk a little bit about the conversion timing and where we expect it to be by end of 2026.

Speaker #5: So, Chris.

Chris Degnan: Yeah. Thanks, Ram. You from path to new patient start, as we talked about, you know, last year was roughly 45 to 60 days. A lot of that, less so the benefit verification, which only takes, you know, a few days once it's submitted to the hub. It was more the operational pieces and also as, you know, more use was in the hospital last year, just getting on hospital formulary, et cetera. We do expect, you know, as this gets adopted into clinical workflows, that our time to conversion is going to compress. We did see that already in Q1. Average time to conversion in Q1 was 30 to 35 days.

Speaker #1: Yeah. Thanks, Ram. So you're from path to new patient star, as we talked about, last year was roughly 45 to 60 days. And a lot of that less so the benefit verification, which only takes a few days once it's submitted to the hub.

Speaker #1: It was more the operational pieces, and also, as more use was in the hospital last year, just getting on hospital formulary, etc. So we do expect, as this gets adopted into clinical workflows, that our time to conversion is going to compress.

Speaker #1: And we did see that already in Q1. So, average time to conversion in Q1 was 30 to 35 days. So we're starting to see that walk down.

Chris Degnan: We're starting to see that walk down, and we expect ultimately in steady state to be closer to where we are today for JELMYTO, which is 2 to 3 weeks from path to new patient start.

Speaker #1: And we expect, ultimately, in steady state to be closer to where we are today for Gelmido, which is two to three weeks from path to new patient start.

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

Speaker #3: Great. Thank you so much and congrats on all the recent progress.

Speaker #5: Thanks, Ram.

Liz Barrett: Thanks, Ram.

Speaker #6: Thank you. Our last question comes from Paul Choi. From Goldman Sachs. Paul, the line is now open.

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

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

Speaker #7: Thank you. Thanks for taking our questions. And let me add my congratulations on the good results. Liz, I was wondering if you could maybe provide some color on where the Zesduri uptake is happening, specifically what is the sort of percentage of overlap with existing Gelmido users versus prescribers who are just new and outside your current commercial base or prior commercial base?

Speaker #7: And my second question from Mark is I was wondering if you could expand a little bit more on UGN 103 development plans and potentially a adjuvant trial that seems to be the direction of travel for some of your competitors.

Speaker #7: And just what that kind of trial in your mind might look like for UGN 103. Thank you.

Speaker #5: Yeah. Sure. Paul, Mark, would you like to start there?

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

Speaker #8: Yeah. Sure. Thanks, Liz. Thank you, Paul. So yes, we are excited about UGN 103's NDA submission this year. And expect the approval for the successor molecule for Zesduri.

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

Speaker #8: In terms of expanding the label or the indication into other aspects of the disease spectrum, we certainly are in the process of finalizing conversations about what trials would look like as adjuvant therapy for newly diagnosed intermediate-risk disease and also for high-grade high-risk disease both of those trial designs anticipate prospective randomized adjuvant therapy with a control arm and we are in the process of finalizing the details of those trials.

Speaker #8: And we anticipate initiating the high-grade trial this year. That's our current plan.

Speaker #5: Yeah. I think the only additional comment I'll make about that is I still hold to what I said earlier. In the IR space is that I think doing it without having to do surgery is a real benefit.

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

Speaker #5: Having said that, because some physicians want to, it's probably in our best interest to at least generate some data of using Zesduri in the adjuvant setting.

Speaker #5: So, it's one of the reasons we're doing what Mark was talking about. To go to your first question around Jelmyto overlap, absolutely. And some of our initial users were Jelmyto users.

Speaker #5: And we see today, over 50% of the Zesduri users are Gelmido users. That's not surprising, obviously, because 95% of Gelmido users are Zesduri, could or potential Zesduri.

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

Speaker #5: It doesn't flip side is not necessarily the case given the rare nature of the upper tract urothelial carcinoma. But so we're seeing, again, now in the beginning, I would say it was even higher we started out some of our initial users were Gelmido users.

Speaker #5: So probably 80%. But now it's a little over 50%. So we're seeing both the Gelmido and non-Gelmido users using Zesduri. So I hope that helps, Paul.

Speaker #7: Yes, it does. Thank you very much, Liz.

Paul Choi: Yes, it does. Thank you very much, Liz.

Liz Barrett: Okay. Thank you.

Speaker #5: Okay. Thank you.

Speaker #6: Thank you. We have one last question. The last question will be from Leland Gershel from Oppenheimer. Leland, the line is open.

Operator: Thank you. We have one last question.

Liz Barrett: Okay.

Operator: The last question will be from Leland Gershell from Oppenheimer. Leland, the line is open.

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

Speaker #3: Great. Thanks for taking our questions. And terrific to see Zesduri hitting its stride here. Just Liz and team, wanted to ask appreciate the additional launch metrics that you provided.

Speaker #3: Looks like you're making solid progress there on activated sites and prescribers. I was wondering if you could share with us where you are sort of in the context of your overall rollout plan with respect to the goals of those various metrics.

Speaker #3: Thanks very much.

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

Speaker #5: Yeah. Thanks, Leland. And thanks for the support. Very, very early. So we're nowhere near where we want to be. We have a target of 8,500 doctors, healthcare providers, and as we talked about today, we've only got 300 unique prescribers.

Speaker #5: So we have a long way to go. But I think that's great news, right? It's good news for us because that means the opportunity since we're already seeing the great results so far in Q1, we believe that those that have used it were getting very positive feedback.

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

Speaker #5: But we have a long way to go with new users, and we'll continue to add new users. And part of our—I mean, our strategy is both breadth and depth, because we also do know that those physicians who have already used it have more patients that they could use it on.

Speaker #5: But absolutely, we have a long way to go. So we're just in a very, very early stages of where we want to be with penetration among docs.

Speaker #5: So long way to go. Very, very early in early stages.

Speaker #3: Great. Thanks very much.

Leland Gershell: Great. Thanks so much.

Speaker #7: All right.

Liz Barrett: All right. Thanks, Leland.

Speaker #5: Thanks, Leland.

Speaker #6: Thank you. I am 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.

Operator: Thank you. I am showing no further questions.

Liz Barrett: Okay, great.

Operator: This concludes.

Liz Barrett: Yeah.

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

Speaker #5: Thanks, and sorry about that. 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 known we could bring.

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

Speaker #5: I think the most important thing that we really like to focus on is the impact that we're having on patients because we really do believe if you do the right thing for the patients, the business in our shareholders will be rewarded for that.

Speaker #5: So thanks for all the support. Happy to continue to share progress as we get into Q2 and beyond. So thanks again for everybody's support.

Speaker #5: And we will talk to you guys soon. You can disconnect now, operator.

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