Q4 2025 UroGen Pharma Ltd Earnings Call

March 2, 2026

Operator: Good day. Thank you for standing by. Welcome to UroGen Pharma's Q4 2025 Earnings Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question-and-answer session. To ask a question during the session, you'll need to press star one one on your telephone. You will hear an automated message advising your hand is raised. To withdraw your question, please press star one one again. Please be advised that today's conference is being recorded. I'd now like to hand the conference over to Vincent Perrone, Senior Director of Investor Relations. Please go ahead.

Speaker #1: Good day, and thank you for standing by. Welcome to UroGen Pharma's fourth quarter 2025 earnings call. At this time, all participants are in a listen-only mode.

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

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

Speaker #1: I'd now like to hand the conference over to Vincent Perrone, Senior Director of Investor Relations. Please go ahead.

Speaker #2: Thank you. Good morning, everyone, and welcome to UroGen Pharma's full year 2025 financial results and business update conference call. Earlier this morning, we issued two press releases.

Vincent Perrone: Thank you. Good morning, everyone, and welcome to UroGen Pharma's full year 2025 financial results and business update Conference Call. Earlier this morning, we issued two press releases. The first providing an overview of the refinancing of our debt facility with Pharmakon Advisors, and the second providing an overview of our recent corporate highlights and financial results for the Q4 and year-ended 31 December 2025. Both releases 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, David Lin, Chief Commercial Officer, and Chris Degnan, Chief Financial Officer. On today's call, we will be making certain forward-looking statements.

Speaker #2: The first is providing an overview of the refinancing of our debt facility with Pharmakon Advisors, and the second is providing an overview of our recent corporate highlights and financial results for the fourth quarter and year ended December 31, 2025.

Speaker #2: Both releases 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; David Lin, Chief Commercial 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 Gelmido and Zesturi, our ongoing and planned clinical trials and non-clinical studies, the commercial and clinical development milestones, market and revenue opportunities, our commercialization and long-term growth strategy and expectations, as well as anticipated data, regulatory filings and decisions, 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 Jelmyto and ZUSDURI, our ongoing and planned clinical trials and non-clinical studies, the commercial and clinical development milestones, market and revenue opportunities, our commercialization and long-term growth strategy and expectations, as well as anticipated data, regulatory filings and decisions, 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 Barrett, Chief Executive Officer.

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: Your caution 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 Barrett, Chief Executive Officer.

Speaker #3: Thanks, Vincent. Good morning, and thank you for joining us today. Our top priority is the commercial launch of Zesturi, and recurrent low-grade intermediate-risk non-multi-invasive bladder cancer, a pivotal step in advancing our long-term growth strategy.

Liz Barrett: Thanks, Vincent. Good morning, and thank you for joining us today. Our top priority is the commercial launch of ZUSDURI in recurrent low-grade intermediate-risk non-muscle invasive bladder cancer, a pivotal step in advancing our long-term growth strategy. As we outlined in our earnings release this morning, we are encouraged by the early 2026 trajectory following the permanent J-code becoming effective 1 January. ZUSDURI revenue in 2025 was $15.8 million, reflecting early launch dynamics as we work through typical reimbursement and operational steps necessary to build the foundation for broader adoption. With a permanent J-code now in place, a key barrier to adoption has been removed, facilitating more predictable patient access. Since that milestone, as expected, we have seen a clear acceleration across key launch indicators, including the number of new and repeat prescribers, patient enrollment forms, and new patient starts.

Speaker #3: As we outlined in our earnings release this morning, we are encouraged by the early 2026 trajectory following the permanent J code becoming effective January 1st.

Speaker #3: Zesturi revenue in 2025 was $15.8 million, reflecting early launch dynamics as we work through typical reimbursement and operational steps. This is necessary to build the foundation for broader adoption.

Speaker #3: With a permanent J code now in place, a key barrier to adoption has been removed. Facilitating more predictable patient access. Since that milestone, as expected, we have seen a clear acceleration across key launch indicators.

Speaker #3: Including the number of new and repeat prescribers, patient enrollment forms, and new patient starts. Overall, we are pleased with how the launch has unfolded in early 2026, and we are on track with the assumptions we've made around its trajectory.

Liz Barrett: Overall, we are pleased with how the launch is unfolding in early 2026, we are on track with the assumptions we've made around its trajectory. ZUSDURI addresses a large and underserved market, based on our assumptions regarding market penetration, pricing, and physician adoption, we believe ZUSDURI has the potential to achieve greater than $1 billion in peak revenue. Importantly, ZUSDURI provides the first and only medication approved by the FDA that can provide patients with a primary office-based therapy that can result in extended recurrence and treatment-free living. Turning to the rest of the business, Jelmyto generated net rep product revenue of $94 million for the full year 2025, reflecting continued underlying demand growth. We are also advancing our pipeline in a disciplined manner.

Speaker #3: Zesturi addresses a large and underserved market, and based on our assumptions regarding market penetration, pricing, and position adoption, we believe Zesturi has the potential to achieve greater than 1 billion dollars in peak revenue.

Speaker #3: Importantly, Zesturi provides the first and only medication approved by the FDA that can provide patients with a primary office-based therapy that can result in extended recurrence and treatment-free living.

Speaker #3: Turning to the rest of the business, Gelmido generated net rep product revenue of 94 million dollars for the full year 2025, reflecting continued underlying demand growth.

Speaker #3: We are also advancing our pipeline in a disciplined manner, UGN 103, our next-generation formulation of Zesturi, demonstrating compelling complete response results in the phase three utopia trial, consistent with the envisioned study.

Liz Barrett: UGN-103, our next-generation formulation of ZUSDURI, demonstrated compelling complete response results in the phase III ENVISION study. We remain on track to submit an NDA in recurrent low-grade intermediate-risk non-muscle invasive bladder cancer in the second half of 2026, with potential FDA approval in 2027. With a clear regulatory pathway established for UGN-103 in low-grade IR non-muscle invasive bladder cancer, we are evaluating its potential in additional bladder cancer settings, including as an adjuvant in intermediate and high risk non-muscle invasive bladder cancer as part of our broader life cycle strategy. UGN-104, our next-generation formulation of Jelmyto, continues to progress through phase III, with enrollment expected to complete by the end of 2026. Finally, following the refinancing of our term loan with Pharmakon, we have further strengthened our balance sheet and enhanced our financial flexibility.

Speaker #3: We remain on track to submit an NDA and recurrent low-grade intermediate-risk non-multi-invasive bladder cancer in the second half of 2026. With potential FDA approval in 2027.

Speaker #3: With a clear regulatory pathway established for UGN 103 and low-grade IR non-multi-invasive bladder cancer, we are evaluating its potential in additional bladder cancer settings, including as an adjuvant and intermediate and high-risk non-multi-invasive bladder cancer, as part of our broader lifecycle strategy.

Speaker #3: UGN 104, our next-generation formulation of Gelmido, continues to progress through phase three, with enrollment expected to complete by the end of 2026. Finally, following the refinancing of our term loan with pharmacon, we have further strengthened our balance sheet and enhanced our financial flexibility.

Speaker #3: Together with our existing cash on hand, this refinancing provides additional non-dilutive capital that supports our operating plan and allows us to continue executing our strategy in a disciplined manner.

Liz Barrett: Together with our existing cash on hand, this refinancing provides additional non-dilutive capital that supports our operating plan and allows us to continue executing our strategy in a disciplined manner. Importantly, our fortified balance sheet enables us to fully support the ongoing ZUSDURI launch, advance our next-generation pipeline, and thoughtfully pursue life cycle management opportunities over time. We believe this approach positions us well to allocate capital responsibly and create long-term value for patients and shareholders. I will now turn the call over to Mark for a clinical update. Mark?

Speaker #3: Importantly, our fortified balance sheet enables us to fully support the ongoing Zesturi launch, advance our next-generation pipeline, and thoughtfully pursue lifecycle management opportunities over time.

Speaker #3: We believe this approach positions us well to allocate capital responsibly and create long-term value for patients and shareholders. I will now turn the call over to Mark for a clinical update.

Speaker #3: Mark?

Speaker #2: Thank you, Liz. As a reminder, the envisioned trial, which is supported approval of Zesturi, demonstrated an approximately 80% complete response rate at three months.

Mark Schoenberg: Thank you, Liz. As a reminder, the ENVISION trial, which supported approval of ZUSDURI, demonstrated an approximately 80% complete response rate at 3 months. Importantly, among those patients who achieved a complete response, the probability of remaining event-free at 12 months was approximately 80% by Kaplan-Meier estimate, and at 24 months was approximately 72% by Kaplan-Meier estimate. In practical terms, that translates to a substantial proportion of patients expected to remain disease-free 2 years following treatment. ZUSDURI is delivered as a convenient 6-dose regimen in the outpatient setting and does not require surgery or maintenance therapy. Taken together, these clinical and practical advantages support ZUSDURI's growing role for adults with recurrent low-grade intermediate risk NMIBC and position it competitively within an evolving treatment landscape.

Speaker #2: Importantly, among those patients who achieved a complete response, the probability of remaining event-free at 12 months was approximately 80% by Kaplan-Meier estimate, and at 24 months was approximately 72% by Kaplan-Meier estimate.

Speaker #2: In practical terms, that translates to a substantial proportion of patients expected to remain disease-free two years following treatment. Zesturi has delivered as a convenient six-dose regimen in the outpatient setting and does not require surgery or maintenance therapy.

Speaker #2: Taken together, these clinical and practical advantages support Zesturi's growing role for adults with recurrent low-grade intermediate-risk and MIBC, and position it competitively within an evolving treatment landscape.

Speaker #2: Beyond the clinical data, I would note that what I'm about to share reflects anecdotal feedback from early adopters and patient conversations rather than formal study outcomes.

Mark Schoenberg: Beyond the clinical data, I would note that what I'm about to share reflects anecdotal feedback from early adopters and patient conversations rather than formal study outcomes. From those discussions, we are hearing that ZUSDURI is integrating smoothly into routine practice. Physicians have commented on the simplicity of administration and the ability to incorporate the six-dose regimen into existing patient workflows without requiring procedural changes or additional infrastructure. Several urologists have shared that following their first experience with ZUSDURI, the process becomes predictable and manageable within the normal flow of their clinic. We are also hearing encouraging feedback from the patient perspective. For individuals who have undergone multiple TURBT procedures, having a non-surgical treatment option delivered in the outpatient setting has been meaningful. Physicians have described patients as being receptive to, and in some cases enthusiastic about, the opportunity to avoid additional surgery under general anesthesia while maintaining disease control.

Speaker #2: From those discussions, we are hearing that Zesturi is integrating smoothly into routine practice. Physicians have commented on the simplicity of administration and the ability to incorporate the six-dose regimen into existing patient workflows without requiring procedural changes or additional infrastructure.

Speaker #2: Several urologists have shared that following their first experience with Zesturi, the process becomes predictable and manageable within the normal flow of their clinic. We are also hearing encouraging feedback from the patient perspective.

Speaker #2: For individuals who have undergone multiple TURBT procedures, having a nonsurgical treatment option delivered in the outpatient setting has been meaningful. Physicians have described patients as being receptive to and, in some cases, enthusiastic about the opportunity to avoid additional surgery under general anesthesia while maintaining disease control.

Speaker #2: Taken together, while anecdotal, this early feedback reinforces our confidence in how Zesturi’s clinical durability and practical ease of use are translating into real-world adoption.

Mark Schoenberg: Taken together, while anecdotal, this early feedback reinforces our confidence in how ZUSDURI's clinical durability and practical ease of use are translating into real-world adoption. Turning now to the pipeline. UGN-103 is our next-generation mitomycin-based formulation for adults with recurrent low-grade intermediate risk non-muscle invasive bladder cancer. We are developing UGN-103 to build on the foundation established by ZUSDURI. UGN-103 is designed to improve upon the current formulation with a shorter manufacturing process and a more streamlined reconstitution procedure. Results from the ongoing UTOPIA phase III trial demonstrated a 77.8% complete response rate at 3 months. We have aligned with the FDA that the data from this trial can support an NDA submission in this indication. We are planning to submit in second half of 2026, which would position us for potential FDA approval in 2027.

Speaker #2: Turning now to the pipeline. UGN 103 is our next-generation mitomycin-based formulation for adults with recurrent low-grade intermediate-risk non-muscle-invasive bladder cancer. We are developing UGN 103 to build on the foundation established by Zesturi.

Speaker #2: UGN 103 is designed to improve upon the current formulation with a shorter manufacturing process and a more streamlined reconstitution procedure. Results from the ongoing utopia phase three trial demonstrated a 77.8% complete response rate at three months.

Speaker #2: We have aligned with the FDA that the data from this trial can support an NDA submission in this indication and we are planning to submit in the second half of 2026, which would position us for potential FDA approval in 2027.

Speaker #2: As Liz mentioned, we are evaluating lifecycle management and pipeline expansion opportunities for UGN-103 beyond low-grade, intermediate-risk disease. This includes exploration of its potential in high-grade and MIBC, as well as an adjuvant setting for intermediate-risk patients.

Mark Schoenberg: As Liz mentioned, we are evaluating life cycle management and pipeline expansion opportunities for UGN-103 beyond low-grade intermediate risk disease. This includes exploration of its potential in high-grade NMIBC, as well as an adjuvant setting for intermediate risk patients. We anticipate holding Type C meeting with the FDA in Q2 or Q3 to align on the development plans for these programs. We expect both studies to be randomized, controlled, and event-driven trials. Subject to regulatory alignment with the FDA, we intend to initiate the high-grade NMIBC study in the second half of 2026. We look forward to providing additional details as those plans are finalized. UGN-104, our next-generation program for low-grade upper tract urothelial cancer, continues to progress in phase III, with enrollment expected to complete by the end of 2026.

Speaker #2: We anticipate holding type C meetings with the FDA in the second or third quarter to align on the development plans for these programs. We expect both studies to be randomized, controlled, and event-driven trials.

Speaker #2: Subject to regulatory alignment with the FDA, we intend to initiate the high-grade and MIBC study in the second half of 2026. We look forward to providing additional details as those plans are finalized.

Speaker #2: UGN 104, our next-generation program for low-grade upper tract urothelial cancer, continues to progress in phase three, with enrollment expected to complete by the end of 2026.

Speaker #2: UGN 501 is our investigational next-generation oncolytic virus and development for high-risk non-muscle-invasive bladder cancer. IND enabling studies are well underway and our goal is to submit the IND and initiate a phase one clinical trial in 2026.

Chris Degnan: UGN-501 is our investigational next generation oncolytic virus in development for high-risk non-muscle invasive bladder cancer. IND enabling studies are well underway, and our goal is to submit the IND and initiate a phase I clinical trial in 2026. While our initial focus remains bladder cancer, we see potential to explore this platform more broadly beyond the genitourinary system. Overall, we believe the recent progress made across our programs positions us well over the coming year with multiple clinical and regulatory milestones ahead. I will now turn the call over to David for the commercial update.

Speaker #2: While our initial focus remains bladder cancer, we see potential to explore this platform more broadly beyond the genitourinary system. Overall, we believe the recent progress made across our program's physicians as well, over the coming year with multiple clinical and regulatory milestones ahead.

Speaker #2: I will now turn the call over to David for the commercial update.

Speaker #3: Thank you, Mark. I want to reinforce what Liz shared earlier. We are very encouraged by how the Zesturi launch is developing, and it continues in line with our expectations.

David Lin: Thank you, Mark. I want to reinforce what Liz shared earlier. We are very encouraged by how the ZUSDURI launch is developing, and it continues in line with our expectations. The commercial execution we're seeing reflects the significant groundwork laid throughout 2025 as we are beginning to see that preparation translate into broader engagement across the urology community. From FDA approval through year-end 2025, our focus was on intentionally building the commercial foundation required for long-term success. We expanded and trained the commercial organization, established reimbursement pathways, and worked closely with urology practices to support operational readiness ahead of broader adoption. ZUSDURI generated $1.8 million in net product revenue in Q3 and $14 million in Q4, bringing full year 2025 revenue to $15.8 million. As discussed, these early quarters reflected the foundational launch phase during the miscellaneous J-code period.

Speaker #3: The commercial execution, we're seeing, reflects the significant groundwork laid throughout 2025. As we are beginning to see that preparation translate into broader engagement across the urology community.

Speaker #3: From FDA approval through year-end 2025, our focus was on intentionally building the commercial foundation required for long-term success. We expanded and trained the commercial organization, established reimbursement pathways, and worked closely with urology practices to support operational readiness ahead of broader adoption.

Speaker #3: Zesturi generated $1.8 million in net product revenue in Q3, and $14 million in Q4. Bringing full-year 2025 revenue to $15.8 million. As discussed, these early quarters reflected the foundational launch phase during the miscellaneous J code period.

Speaker #3: As of December 31st, 2025, we had 838 activated sites of care, with 102 unique prescribers and 32 repeat prescribers. Payer execution continued to support access, with over 95% of covered lives having open access to Zesturi by year-end.

David Lin: As of 31 December 2025, we had 838 activated sites of care with 102 unique prescribers and 32 repeat prescribers. Payer execution continued to support access, with over 95% of covered lives having open access to ZUSDURI by year-end. The permanent product-specific J-code became effective on 1 January 2026. Since that time, we have seen a noticeable step up in adoption and utilization trends through January and February. It's still early days. However, the directional indicators are consistent with our expectations that reimbursement clarity would support broader uptake. Importantly, we are not seeing any material friction points in reimbursement, logistics, or treatment delivery. Just as important, we are beginning to see greater engagement from community-based urologists.

Speaker #3: The permanent product-specific J code became effective on January 1st, 2026, and since that time, we have seen noticeable step-up in adoption and utilization trends through January and February.

Speaker #3: It's still early days. However, the directional indicators are consistent with our expectations that reimbursement clarity would support broader uptake. Importantly, we are not seeing any material friction points in reimbursement, logistics, or treatment delivery.

Speaker #3: Just as important, we are beginning to see greater engagement from community-based urologists. As expected, many community practices were more cautious prior to the permanent J code going into effect, and we are now seeing growing participation as reimbursement processes normalize and confidence builds.

David Lin: As expected, many community practices were more cautious prior to the permanent J-code going into effect, and we are now seeing growing participation as reimbursement processes normalize and confidence builds. We believe this shift toward increased community adoption will be an important contributor to growth as we move through 2026. We are also tracking the conversion timeline from patient enrollment form, or PEF, to dosing. We've previously said that conversion cycle was in the 45 to 60-day range, reflecting the onboarding and workflow integration typical of a new product launch. Over the course of 2026, we expect conversion time to narrow as sites gain familiarity and operational efficiencies improve, ultimately moving closer to the 2 to 3-week time frame we see today with JELMYTO.

Speaker #3: We believe this shift toward increased community adoption will be an important contributor to growth as we move through 2026. We are also tracking the conversion timeline from patient enrollment form, or PEF, to dosing.

Speaker #3: We've previously said that conversion cycle was in the 45 to 60-day range, reflecting the onboarding and workflow integration typical of a new product launch.

Speaker #3: Over the course of 2026, we expect conversion time to narrow as sites gain familiarity and operational efficiencies improve, ultimately moving closer to the two- to three-week timeframe we see today with Gelmido.

Speaker #3: As we continue through 2026, our commercial organization is scaled to support the 8,500 urologists in our target universe who treat approximately 90% of the low-grade intermediate-risk non-muscle-invasive bladder cancer patients in the US.

David Lin: As we continue through 2026, our commercial organization is scaled to support the 8,500 urologists in our target universe, who treat approximately 90% of the low-grade intermediate-risk non-muscle invasive bladder cancer patients in the US. Our focus remains on disciplined execution, expanding peer-to-peer education, supporting appropriate patient identification, and ensuring practices have the tools they need as adoption continues to build in a measured and sustainable way. We have also begun to increase our investment in patient awareness initiatives to complement our physician-focused efforts, ensuring that patients are informed about their treatment options. Turning to Jelmyto, it generated net product revenue of $94 million in 2025. While growth has moderated for a more mature product, we continue to drive consistent engagement and steady demand across the treating community based in part on compelling, durable, complete response data.

Speaker #3: Our focus remains on disciplined execution expanding peer-to-peer education, supporting appropriate patient identification, and ensuring practices have the tools they need as adoption continues to build in a measured and sustainable way.

Speaker #3: We have also begun to increase our investment in patient awareness initiatives to complement our physician-focused efforts ensuring that patients are informed about their treatment options.

Speaker #3: Turning to Gelmido, it generated net product revenue of $94 million in 2025. While growth has moderated for a more mature product, we continue to drive consistent engagement and steady demand across the treating community.

Speaker #3: Based in part on compelling durable complete response data. Importantly, the expansion of our commercial organization in support of Zesturi also enhances our overall urology presence, which we believe can provide incremental support to the Gelmido franchise over time.

David Lin: Importantly, the expansion of our commercial organization in support of ZUSDURI also enhances our overall urology presence, which we believe can provide incremental support to the Jelmyto franchise over time. I will now hand it over to Chris to discuss financials.

Speaker #3: I will now hand it over to Chris to discuss financials.

Speaker #4: Thank you, David. Revenues were $109.8 million for the year-end in December 31st, 2025, compared with $90.4 million in 2024. The 21% year-over-year increase was driven by the commercial launch of Zesturi in 2025, as well as increased sales of Gelmido.

Chris Degnan: Thank you, David. Revenues were $109.8 million for the year ended 31 December 2025, compared with $90.4 million in 2024. The 21% year-over-year increase was driven by the commercial launch of ZUSDURI in 2025, as well as increased sales of Jelmyto. Research and development expenses for the year ended 31 December 2025, were $67.1 million, compared with $57.1 million in 2024. The year-over-year increase was primarily driven by higher manufacturing costs for ZUSDURI, which are recognized as R&D expenses prior to receiving FDA approval. Costs associated with the Phase 3 trials for UGN-103 and UGN-104 and the acquisition of UGN-501, partially offset by lower clinical trial costs and regulatory expenses in connection with ZUSDURI.

Speaker #4: Research and development expenses for the year-end in December 31st, 2025, were $67.1 million. Compared with $57.1 million in 2024. The year-over-year increase was primarily driven by higher manufacturing costs for Zesturi which are recognized as R&D expenses prior to receiving FDA approval.

Speaker #4: Costs associated with the phase three trials for UGN-103 and UGN-104 and the acquisition of UGN-501, partially offset by lower clinical trial costs and regulatory expenses in connection with Zestori.

Speaker #4: Selling, general, and administrative expenses were $155.1 million for the full year ended December 31, 2025, compared to $121.2 million for the full year 2024. The year-over-year increase in SG&A expenses was primarily driven by Zesturi commercial activities, including the sales force expansion following Zesturi approval in 2025, as well as an increase in overall commercial operation costs.

Chris Degnan: Selling, general and administrative expenses were $155.1 million for the full year ended 31 December 2025, compared to $121.2 million from the full year 2024. The year-over-year increase in SG&A expenses was primarily driven by ZUSDURI commercial activities, including the sales force expansion following ZUSDURI approval in 2025, as well as an increase in overall commercial operation costs. Financial expense related to the prepaid forward obligation to RTW Investments was $18.5 million for the year ended 31 December 2025, compared with $23.4 million in the prior year. The decrease was driven primarily by changes in underlying assumptions for remeasuring the effective interest rate.

Speaker #4: Financing expense related to the prepaid forward obligation to RTW investments was $18.5 million for the year-end in December 31st, 2025, compared with $23.4 million in the prior year.

Speaker #4: The decrease was driven primarily by changes in underlying assumptions for re-measuring the effective interest rate. Interest expense on our prior $125 million term loan facility with Pharmacon advisors was $15.3 million in 2025, compared with $12.5 million in 2024.

Chris Degnan: Interest expense on our prior $125 million term loan facility with Pharmakon Advisors was $15.3 million in 2025, compared with $12.5 million in 2024. The increase was primarily attributed to the interest expense on the $25 million third tranche of the loan that was funded in September 2024. We reported net loss of $153.5 million, or $3.19 per basic and diluted share for the year ended 31 December 2025, compared with a net loss of $126.9 million or $2.96 per basic and diluted share in 2024. As of 31 December 2025, our cash equivalents, and marketable securities totaled $120.5 million.

Speaker #4: The increase was primarily attributed to the interest expense on the $25 million third tranche of the loan that was funded in September 2024. We reported a net loss of $153.5 million, or $3.19 per basic and diluted share, for the year ended December 31, 2025, compared with a net loss of $126.9 million, or $2.96 per basic and diluted share, in 2024.

Speaker #4: As of December 31st, 2025, our cash, cash equivalents, and marketable securities totaled $120.5 million. As Liz mentioned, today we announced that we have entered into a second amended and restated loan agreement with Pharmacon advisors providing for a senior secured term loan facility of up to $250 million.

Chris Degnan: As Liz mentioned, today we announced that we have entered into a second amended and restated loan agreement with Pharmakon Advisors, providing for a senior secured term loan facility of up to $250 million, consisting of two tranches. The initial tranche of $200 million was funded at closing and was used to refinance our existing $125 million term loan facility and provide additional non-dilutive capital. The agreement also includes a second tranche of $50 million, which may be drawn at our discretion through 30 June 2027, subject to customary conditions. All outstanding loans with Pharmakon will accrue interest at a fixed rate of 8.25% and will be repaid with four equal quarterly principal payments beginning in Q1 2030. The facility includes customary prepayment provisions, including applicable premiums and make-whole amounts.

Speaker #4: Consisting of two tranches. The initial tranche of $200 million was funded at closing and was used to refinance our existing $125 million term loan facility and provide additional non-diluted capital.

Speaker #4: The agreement also includes a second tranche of $50 million, which may be drawn at our discretion through June 30, 2027, subject to customary conditions.

Speaker #4: All outstanding loans with Pharmacon will accrue interest at a fixed rate of 8.25% and will be repaid with four equal quarterly principal payments beginning in the first quarter of 2030.

Speaker #4: The facility includes customary prepayment provisions, including applicable premiums and make-whole amounts. We believe this refinancing enhances our financial flexibility and provides additional non-dilutive capital to support continued investment in the Zesturi launch, lifecycle management initiatives, and advancement of our pipeline, while maintaining a disciplined approach to capital allocation.

Chris Degnan: We believe this refinancing enhances our financial flexibility and provides additional non-dilutive capital to support continued investment in the ZUSDURI launch, lifecycle management initiatives, and advancement of our pipeline while maintaining a disciplined approach to capital allocation. Finally, turning to guidance. We are providing 2026 guidance for Jelmyto net product revenue and total company operating expenses. Given that ZUSDURI remains in the early stages of its launch, we are not providing formal sales guidance for 2026 at this time. 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 #4: Finally, turning to guidance, we are providing 2026 guidance for Gelmido net product revenue and total company operating expenses. Given that Zesturi remains in the early stages of its launch, we are not providing formal sales guidance for 2026 at this time.

Speaker #4: For the full year 2026, net product revenues for Gelmido 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 #4: 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.

Chris Degnan: 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. The anticipated year-over-year increase in company operating expenses is primarily driven by three factors. An increase in non-cash share-based compensation expense attributable to a higher stock price at the 2026 grant date and an overall increase in employee grants. The annualization of costs associated with our sales force expansion following ZUSDURI approval in 2025, and our lifecycle management plans for UGN-103. That concludes our prepared remarks. We will now open up the call to questions. Operator?

Speaker #4: The anticipated year-over-year increase in company operating expenses is primarily driven by three factors. An increase in non-cash share-based compensation expense attributable to a higher stock price at the 2026 grant date and an overall increase in employee grants, the annualization of costs associated with our sales force expansion following Zesturi approval in 2025, and our lifecycle management plans for UGN 103.

Speaker #4: That concludes our prepared remarks. We will now open up the call to questions. Operator?

Speaker #3: As a reminder, if you'd like to ask a question at this time, please press star 11 on your telephone. And wait for your name to be announced.

Operator: As a reminder, if you'd like to ask a question at this time, please press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. Our first question comes from Kelsey Goodwin with Piper Sandler.

Speaker #3: To withdraw your question, please press star 11 again. Our first question comes from Kelsey Goodwin with Piper Sandler.

Speaker #4: Hey, good morning, and thanks for taking our questions. And congrats on the quarter. Maybe first, I know you're not providing anything on the patient enrollment forms, but do you have any color or commentary you can provide there, and maybe a way we could benchmark it to what you're seeing with Gelmido, or what you saw on their launch?

Kelsey Goodwin: Hey, good morning, thanks for taking our questions, congrats on the quarter. Maybe first, I know you're not providing anything on the patient enrollment forms, but do you have any color or commentary you can provide there? Maybe a way we could benchmark it to what you're seeing with Jelmyto or what you saw in their launch. In terms of the potential guidance for ZUSDURI, I guess, when might you be able to provide that? Would that be maybe a 2027 thing? Thank you.

Speaker #4: And then, in terms of the potential guidance for Zestori, I guess, when might you be able to provide that? Or would that be maybe a 2027 thing?

Speaker #4: Thank you.

Speaker #5: Yeah, I'll ask Chris to answer the second question, and then David can answer the first question. So.

Chris Degnan: Yeah. I'll ask Chris to answer the second question. David can answer the first question.

Speaker #6: Yeah, so Kelsey, thanks for the question. It is early in the launch, as we said, and there are certain variables that can affect the near-term uptake.

Chris Degnan: Yeah. Kelsey, thanks for the question. You know, it is early in the launch, as we said, and there are certain variables that can affect the near-term uptake. You know, once we get the better visibility to steady state demand, I would say at least 2 quarters post the permanent J-code, then we could consider providing formal guidance for ZUSDURI.

Speaker #6: So once we get better visibility to steady-state demand—I would say at least two quarters post the permanent J-code—then we could consider providing formal guidance for Zestori.

Speaker #5: Yeah, David, I'll pass.

Chris Degnan: Yeah. David, I'll pass.

Speaker #1: Yeah, hi Kelsey, it's David. With regard to patient enrollments, as expected, since the permanent J code became effective at the beginning of the year, we are seeing a step-up in a number of key indicators.

David Lin: Yeah. Hi, Kelsey. It's David. With regard to patient enrollments, as expected, since the permanent J-code became effective at the beginning of the year, we are seeing step up in a number of key indicators. PEPS being one of them, and that's really in large part due to the fact that we have new writers as well as growing repeat writers. Thanks for the question.

Speaker #1: So, PEST being one of them—and that's really in large part due to the fact that we have new writers, as well as growing repeat writers.

Speaker #1: Thanks for the question.

Speaker #5: Hey, Kelsey, just to put a little bit of a finer point on that—to your point about how's it doing versus Gelmido—I will tell you that, and cautiously tell you, because all of our indicators in the month of February surpassed Gelmido.

Chris Degnan: Hey, Kelsey, just to put a little bit of a finer point on that, to your point about how's it doing versus Jelmyto. I will tell you that, you know, and cautiously tell you 'cause I that all of our indicators in the month of February surpassed

Liz Barrett: Jelmyto. If you think about patient enrollment forms, you think about new patient starts and doses, we are now tracking ahead of where Jelmyto is. Take that into consideration when you think about the number for the year that we've said we're comfortable with where guidance is. If you think about it versus where Jelmyto is, I think that will show you that we are on track for, you know, to hit that number. That's a little bit more color. I know everybody's wanting specific numbers. I think that's the best we're gonna be able to do. I think that should give everybody confidence in kind of where we are right now.

Speaker #5: So, if you think about patient enrollment forms, you think about new patient starts and doses, we are now tracking ahead of where Gelmido is.

Speaker #5: So take that into consideration when you think about the number for the year, that we've said we're comfortable with where guidance is, and if you think about it versus where Gelmido is, I think that will show you that we are on track for to hit that number.

Speaker #5: So just want to add a little bit more color. I know everybody's wanting specific numbers, but I think that's the best we're going to be able to do.

Speaker #5: But I think that should give everybody confidence in kind of where we are right now.

Speaker #4: That's great. Thank you so much.

Kelsey Goodwin: That's great. Thank you so much.

Speaker #3: Our next question comes from Ragharam Selvarajju with HC Wainwright.

Operator: Our next question comes from Raghuram Selvaraju with H.C. Wainwright.

Speaker #7: Thanks so much for taking my questions, and congratulations on all the progress this quarter. I just wanted to drill down on the prescribers and repeat prescribers for a second.

Raghuram Selvaraju: Thanks so much for taking my questions, and congratulations on all the progress this quarter. I just wanted to drill down on the prescribers and repeat prescribers for a second. Two questions here. Firstly, among the repeat prescribers, can you comment on the trend in this number and if you're seeing it steadily ticking up, month-over-month, quarter-over-quarter? Secondly, with respect to those prescribers who have deployed ZUSDURI but are not yet repeat prescribers, have you received any feedback from this group indicating how likely they would be to become repeat prescribers? Are there any specific considerations that are emerging that would prevent them from becoming repeat prescribers?

Speaker #7: So, two questions here. Firstly, among the repeat prescribers, can you comment on the trend in this number, and if you're seeing it steadily ticking up month over month, quarter over quarter?

Speaker #7: And secondly, with respect to those prescribers who have deployed Zestori, but are not yet repeat prescribers, have you received any feedback from this group indicating how likely they would be to become repeat prescribers?

Speaker #7: And are there any specific considerations that are emerging that would prevent them from becoming repeat prescribers?

Speaker #5: Yeah, David?

Liz Barrett: Yeah, David.

Speaker #6: Hi there. Thanks for the question. In terms of repeat prescribers, we are seeing steady growth in I'll just comment in both new and repeat prescribers.

David Lin: Hi there. Thanks for the question. In terms of repeat prescribers, we are seeing steady growth in, I'll just comment, in both new and repeat prescribers. To your point around repeat prescribers, what we see with them is that once they have a very positive experience with a patient and the workflow becomes incorporated into their practice, and they have the confidence around reimbursement, which is now reinforced with the effectiveness of a permanent J-code, that's really what enables them to become repeat prescribers. With many of the new prescribers, what they're really waiting to see is they typically wanna make sure that they have a clean claim submission, and they get reimbursed. As their practices become more familiar with the medicine, implementing it into their workflows, they are very likely to become repeat prescribers.

Speaker #6: So, to your point around repeat prescribers, what we see with them is that once they have a very positive experience with a patient, and the workflow becomes incorporated into their practice, and they have the confidence around reimbursement—which is now reinforced with the effectiveness of a permanent J code—that's really what enables them to become repeat prescribers.

Speaker #6: With many of the new prescribers, what they're really waiting to see is, they typically want to make sure that they have a clean claim submission and they get reimbursed.

Speaker #6: And as their practices become more familiar with the medicine, implementing it into their workflows, they are very likely to become repeat prescribers. And so what we've heard from the prescriber base is that it's a steady growth in, as they become more familiar, they tackle more patients.

David Lin: What we've heard from the prescriber base is that it's a steady growth in as they become more familiar, they tackle more patients.

Speaker #7: Very helpful. And then, just quickly on lifecycle management, I was wondering if you have a sense—assuming timely submission of UGN-103—approximately when you might potentially be in position to introduce it into the market in the United States?

Raghuram Selvaraju: Very helpful. Just quickly on lifecycle management. I was wondering if you have a sense, assuming timely submission of UGN-103, approximately when you might potentially be in position to introduce it into the market in the United States. Secondly, if you could comment at all at this juncture on what you expect the dynamics to be between UGN-103 and ZUSDURI and how you're thinking about 103 relative to ZUSDURI from a commercial positioning standpoint. Thank you.

Speaker #7: And secondly, if you could comment at all at this juncture on what you expect the dynamics to be between UGN-103 and Zestori, and how you're thinking about 103 relative to Zestori from a commercial positioning standpoint.

Speaker #7: Thank you.

Speaker #5: Yeah, so the plan would be to not introduce it into the market until after we get a permanent J code. So what we've discussed is that we would file this year; you'll get approval in 2027.

Liz Barrett: Yeah. The plan would be to not introduce it into the market until after we get a permanent J-code. What, you know, we've discussed is that we would file this year. You'll get approval in 2027, it would likely be the beginning of 2028 when we would be in a position to launch it. What we would do is the goal would be to transition to UGN-103 as quickly as possible. You know, because there's gonna be a lot of confusion, so we have to make sure that we handle that very quickly, so to avoid any of that.

Speaker #5: And so then it would likely be the beginning of 2028 when we would be in a position to launch it. And what we would do is the goal would be to transition to UGN 103 as quickly as possible.

Speaker #5: But because there's going to be a lot of confusion, so we have to make sure that we handle that very quickly. So to avoid any of that, and then at the point in time where we feel confident that we're not going to lose physicians and patients with Zostori and that they'll switch to 103, then we'll make that switch.

Liz Barrett: At the point in time where we feel confident that we're not gonna lose, you know, physicians and patients with ZUSDURI and that they'll switch to one oh three, then we'll make that switch. We will be very purposeful about that and then pull ZUSDURI as quickly as possible. There won't be a lot of the, to your point, the dynamic of one oh three and ZUSDURI being on the market at the same time. That will happen, obviously. There'll be a transition period, but we wanna make that transition period as quick as possible.

Speaker #5: So, we will be very purposeful about that, and then pull Zostori as quickly as possible. So, there won't be a lot of, to your point, the dynamic of 103 and Zostori being on the market at the same time.

Speaker #5: That will happen, obviously. There will be a transition period, but we want to make that transition period as quick as possible.

Speaker #7: Thank you.

Raghuram Selvaraju: Thank you.

Speaker #3: Our next question comes from Michael Schmidt with Guggenheim.

Operator: Our next question comes from Michael Schmidt with Guggenheim.

Speaker #8: Oh, hey. Good morning. Thanks for taking my questions. On Zostori as we could you just provide some more comment on current use? Especially as we think about what types of patients are leveraging Zostori at this point in time?

Michael Schmidt: Oh, hey, good morning. Thanks for taking my questions. On ZUSDURI, you know, could you just provide some more comment on current use, especially as we think about, you know, what types of patients are leveraging ZUSDURI at this point in time? What percentage of patients are, you know, considered unfit for TURBT surgery as opposed to patients that are fit and are just seeking alternatives to surgery? How do you expect that use pattern to shift over the rest of this year? That's question number one. Question number two, I think you did mention some potential lifecycle management opportunities, especially for UGN-103, including evaluation as an adjutant therapy.

Speaker #8: What percentage of patients are considered unfit for TRBT surgery as opposed to patients that are fit and are just seeking an alternative to surgery?

Speaker #8: And how do you expect that use pattern to shift over the rest of this year? So that's question number one. And then, question number two, I think you did mention some potential lifecycle management opportunities, especially for UGN-103, including evaluation as an adjuvant therapy.

Speaker #8: And I'm just curious, based on your market research, how well does the concept of adjuvant therapy in general resonate with patients as opposed to just using therapy as a replacement for surgery?

Michael Schmidt: I'm just curious, based on your market research, how well does the concept of adjuvant therapy in general resonate with patients, as opposed to, you know, just using therapy as a replacement of surgery, you know, instead of as an add-on? How do you think about that? Thank you so much.

Speaker #8: Instead of as an add-on, how do you think about that? Thank you so much.

Speaker #5: Yeah, sure. David can answer the first, and then Mark, please be prepared to answer the question around lifecycle management.

Liz Barrett: Yeah, sure. David can answer the first, and then Mark, be prepared to answer the question around lifecycle management.

Speaker #6: Hey, Michael. This is David. In terms of your question, I think the first thing I'll say is that physician customers have been very enthusiastic about the compelling—about, and as we've gained more experience in the market.

David Lin: Hey, Michael, this is David. In terms of your question, I think the first thing I'll say is that physician customers have been very enthusiastic about the compelling data surrounding ZUSDURI. As we've talked about, as we've gained more experience in the market, that complete response and durability of response really does resonate, and they do see it as a paradigm change. In terms of the patient types that they are giving ZUSDURI, while not a precise science, I will say they're using as we expected. The first would be people who recur early. Second would be those who have frequent recurrences. Third, those who they feel just shouldn't go through another surgery. We're hearing patients across the board, and that's what gives us a lot of confidence that the value proposition is getting across to them.

Speaker #6: That complete response and durability of response really does resonate, and they do see it as a paradigm change. In terms of the patient types that they are giving Zostori while not a precise science, I will say they're using as we expected.

Speaker #6: So the first would be people who recur early. Second would be those who have frequent recurrences. And third, those who they feel just shouldn't go through another surgery.

Speaker #6: So, we're hearing patients across the board, and that's what gives us a lot of confidence that the value proposition is getting across to them.

Speaker #6: That's supported by the fact that we have a permanent J code now in 2026. It has opened up utilization as we discussed in more community practices.

David Lin: That's supported by the fact that we have a permanent J-code now in 2026, has opened up utilization as we discussed in more community practices, and it's really consistent with how we thought about the launch at this point in time.

Speaker #6: And it's really consistent with what we how we thought about the launch at this point in time.

Speaker #8: Michael, thanks. And with respect to the lifecycle management question, the expansion of the use of 103 in the adjuvant setting would be in the setting of treating patients where we currently believe TURBT would be obligatory.

Mark Schoenberg: Michael, thanks. With respect to the life cycle management question, the expansion in the use of 103 in the adjuvant setting would be in the setting of treating patients where we currently believe TURBT would be obligatory. That would be in patients with a new diagnosis where the patient would have had a transurethral resection to make a diagnosis, likely for new onset intermediate-risk disease, as well as new onset high-grade disease, where primary therapy would not be the standard of care, but adjuvant therapy would. We think there would be enthusiasm for it in both settings, and it would expand markedly, the opportunities for patients to take advantage of the benefits of 103 in both settings.

Speaker #8: So that would be in patients with a new diagnosis where the patient would have had a transurethral resection to make a diagnosis. Likely for new onset intermediate risk disease as well as new onset high-grade disease, where primary therapy would not be the standard of care, but would adjuvant therapy would.

Speaker #8: So we think there would be enthusiasm for it in both settings, and it would expand markedly the opportunities for patients to take advantage of the benefits of 103 in both settings.

Speaker #8: So, adjuvant for new diagnosis, intermediate-risk disease, as well as adjuvant therapy for patients with high-risk disease.

Mark Schoenberg: Adjuvant for new diagnosis, intermediate-risk disease, as well as adjuvant therapy for patients with high-risk disease.

Speaker #7: Great. Thanks so much.

Leland Gershell: Great. Thanks so much.

Michael Schmidt: Great. Thanks so much.

Speaker #5: Yeah. And just to add a little bit more color on the patient dynamics—from the adjuvant side of how it's being used today—we don't really know, obviously.

Liz Barrett: Yeah. Just to answer the, you know, add a little bit more color on the patient dynamics with the, you know, from the adjuvant of how it's being used today, we don't really know. Obviously, we don't track that. We do know some physicians today are using it in the adjuvant setting for the recurrence. We don't promote that, right? Because our data is clearly without surgery. I think that that's very important because the idea of not having to go through surgery, while physicians don't love that, may not love that idea, some of them patients really do. The reality of it is that the 80% complete response and the durability that we've shown, keep in mind that that is without surgery.

Speaker #5: We don't track that. We do know some physicians today are using it in the adjuvant setting for the recurrence, but we don't promote that, right?

Speaker #5: Because our data is clearly without surgery. And I think that that's very important because the idea of not having to go through surgery while physicians don't love that may not love that idea.

Speaker #5: Some of them patients really do. And the reality of it is that the 80% complete response and the durability that we've shown—keep in mind that that is without surgery.

Speaker #5: And so we do want to while we do recognize that some physicians may be less comfortable and they'll do it in the adjuvant setting even today, we do want ultimately for them to use it without surgery because we think that's in the best interest of the patient, frankly.

Liz Barrett: We do want to, while we do recognize that some physicians may be less comfortable and they'll do it in the adjuvant setting even today, we do want ultimately for them to use it without surgery because we think that's in the best interest of the patient, frankly. We think that that also differentiates us versus all of our competitors. Anybody coming in, you know, as they're coming in, they're in the adjuvant setting. Right now, we're the only ones that are showing it as a primary. I think that that's gonna be really important as we go forward.

Speaker #5: And we think that that also differentiates us versus all of our competitors. So anybody coming in, as they're coming in, they're in the adjuvant setting, and right now we're the only ones that are showing it as a primary.

Speaker #5: And I think that that's going to be really important as we go forward.

Speaker #3: Our next question comes from Leland Gershel with Oppenheimer.

Operator: Our next question comes from Leland Gershell with Oppenheimer.

Speaker #8: Good morning, and glad to hear the favorable update. Thanks for taking our questions. We have two; one just on the commercial side with the Zostori as you develop that market.

Leland Gershell: Good morning, glad to hear the favorable update. Thanks for taking our questions. We have 2. 1, just on the commercial side with ZUSDURI, as you develop that market. Wanted to ask what you're seeing in terms of the community versus academic centers that are kind of buying into it. Is it different than how JELMYTO proceeded in its early launch?

Speaker #8: Wanted to ask what you're seeing in terms of the community versus academic centers that are kind of buying into it. Is it different than how Gelmito proceeded in its early launch?

Speaker #5: No.

Liz Barrett: Yeah.

Speaker #7: Hey, Leland. So your question around channel mix, it is a little bit different. I think, as you saw with Jelmyto, it is very heavily concentrated with hospitals, particularly in the beginning.

David Lin: Hey, Leland. Your question around channel mix, it is a little bit different. I think as you saw with Jelmyto is very heavily concentrated with hospitals, particularly in the beginning. What we saw in 2025 with ZUSDURI is that we saw about 60% utilization in a hospital-type setting. Obviously, with the effectiveness of a permanent J-code, we expected that that would actually bring on more community users. Since the beginning of the year, we have started to see that happen. As we sit here at the end of February, I can tell you that the mix of settings has started to pivot toward the community setting. We're looking at about 50/50 right now for ZUSDURI.

Speaker #7: What we saw in 2025 with Zostori is that we saw about 60% utilization in a hospital-type setting. And obviously, with the effectiveness of a permanent J code, we expected that that would actually bring on more community users.

Speaker #7: And since the beginning of the year, we have started to see that happen. And as we sit here at the end of February, I can tell you that the mix of settings has started to pivot toward the community setting.

Speaker #7: So we're looking at about 50/50 right now for Zostori and what we do continue to we would expect to see is that as these community settings come on board, they get experience with the using the product, filing claims, and getting reimbursed, we will continue to see continued growth in the community setting over time.

David Lin: What we do expect to see is that as these community settings come on board, they get experience with the using the product, filing claims and getting reimbursed. We will continue to see continued growth in the community setting over time.

Speaker #7: Okay. Great. And then development question, you'd mentioned looking at Zostori in the adjuvant setting and high-risk. Just wondering, if you could share more detail on that and perhaps other expansion opportunities in high-risk, would you be looking at Zostori in combination with others?

Leland Gershell: Okay, great. Development question, you'd mentioned looking at ZUSDURI in the adjuvant setting in high risk. Just wondering if you could share more detail on that and perhaps other expansion opportunities in high risk. Could you be looking at ZUSDURI in combination with others? In the adjuvant setting, would that be in BCG-naive with TURP? Would there be an opportunity in BCG unresponsive? Just curious if you can share any more detail there. Thank you.

Speaker #7: And then in the adjuvant setting, would that be in BCG naive with TURPS, or would it be would there be an opportunity in BCG unresponsive?

Speaker #7: Just curious if you can share any more detail there. Thank you.

Speaker #5: Yeah. Mark?

Liz Barrett: Yeah. Mark?

Speaker #8: Yeah, thank you, Leland. So I think there are a lot of opportunities in high-risk disease. One area we're particularly interested in is in the BCG-unresponsive papillary high-grade disease, where we think there is a real opportunity.

Mark Schoenberg: Yeah. Thank you, Leland. I think there are a lot of opportunities in high-risk disease. One area we're particularly interested in is in the BCG unresponsive capillary high-grade disease, where we think there is a real opportunity. We are in the process of finalizing a protocol to launch an adjuvant trial in high risk.

Speaker #8: So we are in the process of finalizing a protocol to launch an adjuvant trial in high-risk disease. And obviously, we'll be happy to share details when that protocol is finalized.

Aydin Huseynov: disease. Obviously, we'll be happy to share details when that protocol is finalized. We do think that ZUSDURI all by itself, or in this case it would be 103, as a single agent would be very useful for this particular population, and that's where we would start our investigation. Liz may wanna comment further on the possibility of combining it with other agents, however.

Mark Schoenberg: disease. Obviously, we'll be happy to share details when that protocol is finalized. We do think that ZUSDURI all by itself, or in this case it would be 103, as a single agent would be very useful for this particular population, and that's where we would start our investigation. Liz may wanna comment further on the possibility of combining it with other agents, however.

Speaker #8: But we do think that Zostori all by itself or in this case, it would be 103 as a single agent would be very useful for this particular population and that's where we would start our investigation.

Speaker #8: Liz may want to comment further on the possibility of combining it with other agents, however.

Speaker #5: Yeah. I mean, I think we've definitely considered that, but it would be good we definitely want to see how we do with just monotherapy post-TRBT.

Liz Barrett: Yeah, I mean, I think we've definitely considered that. It would be good. We definitely wanna see how we do with just monotherapy, you know, post TURBT. Absolutely open to and have been looking at potential combinations. We'll do that as well. I mean, it's in. It makes sense for us to be in multiple areas and multiple patient populations. Our ability to quickly launch these incremental clinical studies and broaden the patient utilization is a core strategy for us. That's how we will ensure long-term sustainable growth is by really being able to hit all of the patient populations in non-muscle invasive bladder cancer. There's no reason why it shouldn't work across the board, and that's our intention.

Speaker #5: But absolutely open to and have been looking at potential combinations. So we'll do that as well. I mean, it's in it makes sense for us to be in multiple areas and multiple patient populations and so our ability to quickly launch these incremental clinical studies and broaden the patient utilization is at core strategy for us.

Speaker #5: And that's how we will ensure long-term sustainable growth is by really being able to hit all of the patient populations in non-multi-invasive bladder cancer.

Speaker #5: There's no reason why it shouldn't work across the board, and that's our intention.

Speaker #7: Thank you. It's very helpful.

Aydin Huseynov: Thank you. Very helpful.

Leland Gershell: Thank you. Very helpful.

Speaker #3: Our next question comes from Paul Choi with Goldman Sachs.

Operator: Our next question comes from Paul Choi with Goldman Sachs.

Speaker #9: Hi. Good morning and thank you for taking our questions. My first question is, Liz, can you maybe offer a framework about how you're thinking about the level of investment in promoting the Zostori launch given that you eventually plan to transition to UGN 103 in the future and just sort of what level of investment is needed here to generate a positive return on all the investment you're putting into the product currently and in the past?

Paul Choi: Hi, good morning, and thank you for taking our questions. My first question is, Liz, can you maybe offer a framework about how you're thinking about the level of investment in promoting the ZUSDURI launch, given that you eventually plan to transition to UGN-103 in the future, and just sort of, you know, what level of investment is needed here to generate a positive return on all the investment you're putting into the product currently and in the past? My second question is, I think, in the past you've indicated that you thought you had enough capital to sustain yourself to profitability. I guess, you know, how are you thinking about prioritizing capital allocation with this new loan on the forward here?

Speaker #9: And then my second question is, I think in the past you've indicated that you thought you had enough capital to sustain yourself to profitability.

Speaker #9: And so I guess how are you thinking about prioritizing capital allocation with this new loan on the forward here? And do you feel like now your capital position is finally where you need it to be to get to profitability?

Paul Choi: Do you feel like, you know, now your capital position is finally where you need it to be to get to profitability? Thank you for taking our questions.

Speaker #9: Thank you for taking our questions.

Speaker #5: Sure. I'll answer the first and then I'll ask Chris to talk about the longer-term sustainability of the financials in our investment. I think where we are with investing in Zostori versus 103, we're investing in Zostori like 103 doesn't exist.

Liz Barrett: Sure. I'll answer the first, and then I'll ask Chris to talk about the longer term sustainability of the financials and our investment. You know, I think where we are with investing in ZUSDURI versus UGN-103, we're investing in ZUSDURI like UGN-103 doesn't exist. I mean, we are doing everything we can to ensure the maximum opportunity, and we will continue to do that. You know, I'll give you an example. We just had a new, you know, person join the commercial team that was in another company and said, Hey, what is one thing that I really appreciate? That is we have the resources.

Speaker #5: I mean, we are doing everything we can to ensure the maximum opportunity, and we will continue to do that. And I'll give you an example.

Speaker #5: We just had a new person join the commercial team who was in another company and said, 'Hey, one thing that I've really appreciated is that we have the resources.' So, we have resourced this launch like it needs to be resourced.

Liz Barrett: We have resourced this launch like it needs to be resourced, and there is nothing, no stone that we're leaving unturned, including, you know, engaging in patients. While we're not doing broad-based DTC, we clearly are trying to reach patients in a more targeted manner. I would say, again, absolutely, fulfilling every aspect of the launch. We're not looking at it as this is just temporary, and in 2028 we're gonna have. We're not looking at it like that. We're looking at it because what we build for ZUSDURI will be the foundation for UGN-103. We're going after it aggressively and again, not leaving any stones, you know, unturned for the commercial opportunity. I feel really good about where we are from that standpoint, and we'll continue to do that.

Speaker #5: And there is nothing—no stone—that we're leaving unturned, including engaging in patients. So while we're not doing broad-based DTC, we clearly are trying to reach patients in a more targeted manner.

Speaker #5: So I would say, again, absolutely fulfilling every aspect of the launch. So we're not looking at it as, this is just temporary. And in 2028, we're going to have one—we're not looking at it like that.

Speaker #5: We're looking at it because what we build for Zostori will be the foundation for UGN 103. So we're going after it aggressively and again, not leaving any stone unturned for this.

Speaker #5: Commercial opportunity. So, I feel really good about where we are from that standpoint, and we'll continue to do that. And I'll just ask Chris to sort of comment on the expenses and where we're going from here.

Liz Barrett: I'll just ask Chris to sort of comment on, sort of the expenses and where we're going from here.

Speaker #9: Yeah. And thanks, Paul, for the question. So as we said before, I mean, the path to profitability is really tied to the Zostori launch and the uptake and we're on track there.

Chris Degnan: Yeah. Thanks, Paul, for the question. You know, as we said before, I mean, the path to profitability is really tied to the ZUSDURI launch and the uptake, and we're on track there. You know, the purpose of the refinance really accomplished two things for us. One, it meaningfully reduced our cost of capital. The prior loan had a, you know, 7.5% plus 3 months SOFR variable rate, so call it 12% interest rate, and we've reduced that now down to 8.25%. Two, it gave us financial flexibility. One, it extended the repayment period. You know, it was gonna start Q2 next year, now starts Q1 2030, and did bring in additional non-dilutive capital to further build out the balance sheet.

Speaker #9: The purpose of the refinance really accomplished two things for us. One, it meaningfully reduced our cost of capital. So, the prior loan had a 7.5% plus three months SOFR variable rate, so call it a 12% interest rate.

Speaker #9: And we reduced that now down to 8.25%. And then, two, it gave us financial flexibility. So when it extended the repayment period, it was going to start second quarter next year; now it starts first quarter of 2030. And it did bring in additional non-dilutive capital to further build out the balance, disciplined in our approach to capital allocation, balancing path to profitability, and then also making sure that we're investing in the long-term growth strategy.

Chris Degnan: To be clear, we'll remain disciplined in our approach to capital allocation, balancing path to profitability and then also making sure that we're investing in a long-term growth strategy.

Speaker #5: Yeah. And I'll just add that the addition of the $50 million or $75 million does not change what we've said before around path to profitability.

Liz Barrett: I'll just add that the addition of the $50 million or $75 million does not change what we've said before around path to profitability, right? It gives us a cushion and gives us more flexibility, but it doesn't. We're not we didn't do that because we needed, you know, that money to get to profitability, but it definitely gives us flexibility. Just to be really clear, we haven't changed our commentary around path to profitability.

Speaker #5: Right? It gives us a cushion and gives us more flexibility. But it doesn't we didn't do that because we needed that money to get to profitability.

Speaker #5: But it definitely gives us flexibility. So just to be really clear, we haven't changed our commentary around path to profitability.

Speaker #3: As a reminder, if you'd like to ask a question at this time, please press star 11 on your touchstone phone. Our next question comes from Aiden Yusenov with Lattenberg.

Operator: As a reminder, if you'd like to ask a question at this time, please press star one one on your touchtone phone. Our next question comes from Aydin Huseynov with Ladenburg.

Speaker #7: Hi. Good morning. Thanks for taking our questions. I got a couple. One on Zostori, one on UGN 501 for Zostori. Appreciate confirming the long-term guidance for Zostori.

Aydin Huseynov: Hi, good morning. Thanks for taking our questions. I got a couple, one on ZUSDURI, one on UGN-501. For ZUSDURI, appreciate confirming the long-term guidance for ZUSDURI. I just wanted to better understand maybe if you could provide some color in terms of when do you think these peak sales would occur? Is it 2035, 2040? What would happen after you reach those peak sales?

Speaker #7: So I just wanted to better understand maybe if you could provide some color in terms of when do you think this pixels would occur?

Speaker #7: Is it 2035, 2040? And what would happen after you reach those pixels? And for UGN 501, the question is, I just wanted to better understand the RTGL technology and how that would help UGN 501 oncolytic virus to be differentiated from other oncolytic viruses.

[Analyst]: For UGN-501, the question is, I just wanted to better understand the RTGel technology and how that would help UGN-501 oncolytic virus to be differentiated from other oncolytic viruses, whether you'd need a primer to activate the virus? Thank you so much.

Aydin Huseynov: For UGN-501, the question is, I just wanted to better understand the RTGel technology and how that would help UGN-501 oncolytic virus to be differentiated from other oncolytic viruses, whether you'd need a primer to activate the virus? Thank you so much.

Speaker #7: And whether you'd need a primer to activate the virus. Thank you so much.

Speaker #5: Yeah. Thanks. Chris, I'll ask Chris to answer the first question and then we can turn over to Mark to answer around 501.

Liz Barrett: Yeah, thanks. Chris, I'll ask Chris to answer the first question, and then we can turn over to Mark to answer around 501.

Speaker #7: Okay. And thanks. So I mean, path to peak or time to peak, I would assume roughly four years to peak. So now that we have the J code, a four-year ramp to peak is reasonable.

Chris Degnan: Okay. Thanks. I mean, path up, peak or time to peak, you know, I would assume roughly 4 years to peak. Now that we have the J-code, a 4-year ramp to peak is reasonable.

Speaker #5: And Mark, you want to just talk about 501 with and without the gel?

Liz Barrett: Mark, you wanna just talk about 501 with and without the gel?

Speaker #9: Sure. Thank you. So as you as many who are listening know, our current plan to launch phase one study in 501, which we will do this year, in high-grade disease, is an aqueous-based preparation that is preceded by the use of an activating agent that you were alluding to, DDM.

Mark Schoenberg: Sure. Thank you. As you, as many who are listening know, our current plan to launch a phase I study in UGN-501, which we will do this year in high-grade disease, is an aqueous-based preparation that is preceded by the use of an activating agent that you were alluding to, DDM. We are in the process of studying how long dwell time or longer dwell time could potentiate the efficacy of the virus in the setting in which we will initially explore its use, which is obviously intravesical therapy for bladder cancer. We are in the process of doing that currently. Theoretically, again, this is speculation currently, but we are looking into this right now.

Speaker #9: We are in the process of studying how long-dwell time or longer-dwell time could potentiate the efficacy of the virus in the setting in which we will initially explore its use, which is obviously intravesical therapy for bladder cancer.

Speaker #9: So, we are in the process of doing that currently. Theoretically—and again, this is speculation currently—but we are looking into this right now.

Speaker #9: We believe there may be an advantage to a longer dwell time, which may obviate the need for additional interventions prior to introduction of the virus.

Mark Schoenberg: We believe there may be an advantage to a longer dwell time, which may obviate the need for additional interventions prior to introduction of the virus. That's currently under investigation, and we'll obviously share details when we have more to share.

Speaker #9: But that's currently under investigation, and we'll obviously share details when we have more to share.

Speaker #7: Thank you. Thanks so much. Very helpful.

[Analyst]: Thank you. Thanks so much. Very helpful.

Mark Schoenberg: Thank you. Thanks so much. Very helpful.

Speaker #5: Thank you.

Liz Barrett: Thank you.

Speaker #3: That concludes today's question-and-answer session. I'd like to turn the call back to Liz Barrett for closing remarks.

Operator: That concludes today's question and answer session. I'd like to turn the call back to Liz Barrett for closing remarks.

Speaker #5: So, just want to say thank you to everybody for the support, as you heard today. Very excited about how things are going with the launch.

Liz Barrett: Just wanna say thank you to everybody for the support. As you heard today, very excited about how things are going with the launch. you know, we gave information that, you know, hopefully gives you the confidence that you know where we are. We're starting out the year very strong. Obviously, we'll look forward to sharing the, you know, all of the information from the Q1 and the Q1 earnings. Suffice it to say that we're excited about where we are. We think we're in a great position to hit our goals and hit all of the milestones that we expected on ZUSDURI, which Jelmyto doing well as well, and then want to focus in the back half of the year around expansion into other areas.

Speaker #5: We gave information that hopefully gives you the confidence that where we are, we have a we're starting out the year very strong. So we obviously will look forward to sharing the all of the information from the Q1 and the Q1 earnings.

Speaker #5: But suffice it to say that we're excited about where we are. We think we're in a great position. We're to hit our goals and hit all of the milestones that we expected on Zostori, which I might have doing well as well.

Speaker #5: And then we want to focus in the back half of the year around expansion into other areas. So I think from a company perspective, we feel like we're in a great position.

Liz Barrett: I think from a company perspective, we feel like we're in a great position. We're in a great financial position. Things are going really well with the launch. We're executing against our pipeline and expanding so that we actually are in a position where we see the future being long-term sustainable growth and being able to do that. Again, thank you for everybody for hanging in there for all these years. We're finally, I think, at the place where we've all been working towards and appreciate the support. We'll be keeping everybody up to date and look forward to seeing some of you guys at the conference tomorrow. Thanks. Thanks a lot. You can disconnect now, operator.

Speaker #5: We're in a great financial position. Things are going really well with the launch. We're executing against our pipeline and expanding so that we actually are in a position where we see the future being long-term sustainable growth and being able to do that.

Speaker #5: So again, thank you, everybody, for hanging in there for all these years. We're finally, I think, at the place where we've all been working toward.

Speaker #5: And appreciate the support. So we'll be keeping everybody up to date and look forward to seeing some of you guys at the conference tomorrow.

Speaker #5: So, thanks a lot. You can disconnect now, operator.

Operator: This concludes today's conference call. Thank you for participating. You may now disconnect and have a great day.

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