UroGen Pharma (URGN) Update / Briefing June 13, 2025 08:30 AM ET Speaker0 Good day, and thank you for standing by. Welcome to the UroGen Pharma Zasturi Approval Investor Call. At this time, all participants are in a listen only mode. After the speakers' presentation, there will be a question and answer session. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Vincent Perrone, Head of Investor Relations. Please go ahead. Speaker1 ...

Core Viewpoint - UroGen Pharma Ltd. has been downgraded from Buy to Neutral by HC Wainwright & Co. analyst Raghuram Selvaraju due to the FDA's Oncologic Drugs Advisory Committee voting 5-4 against the benefit-risk profile of its investigational therapy UGN-102 for bladder cancer [1][2]. Financial Position - UroGen concluded Q1 2025 with approximately $200 million in cash, cash equivalents, and marketable securities, which is expected to sustain operations through late 2026 even if UGN-102 fails to secure regulatory approval [4]. - The analyst forecasts a net loss of $2.14 per share for 2026, a significant change from the previous projection of earnings of 27 cents [4]. Development Pipeline - UroGen is advancing the development of UGN-103 and UGN-104, next-generation mitomycin-based formulations, which utilize the RTGel delivery platform combined with a novel mitomycin formulation licensed from medac GmbH [5]. - The Phase 3 UTOPIA trial for UGN-103 is currently enrolling patients, with enrollment expected to conclude by mid-2025 and top-line data anticipated shortly thereafter [5][6]. - If the results from UGN-103 are positive, a regulatory submission could occur in 2026, potentially leading to FDA approval by 2027 [6].

UroGen Pharma (URGN) Q1 2025 Earnings Call May 12, 2025 10:00 AM ET Company Participants Vincent Perrone - Senior Director of Investor RelationsLiz Barrett - President & CEOMark Schoenberg - Chief Medical OfficerDavid Lin - Chief Commercial OfficerChris Degnan - CFOKelsey Goodwin - Vice PresidentGeorge Farmer - Managing Director Conference Call Participants Tara Bancroft - Director, Senior Analyst, Biotech Equity ResearchLeland Gershell - MD & Senior Biotechnology AnalystRaghuram Selvaraju - Managing Direct ...

Financial Data and Key Metrics Changes - UroGen reported net product revenues of $20.3 million for Q1 2025, an 8% year-over-year increase from $18.8 million in Q1 2024, driven by a 12% underlying demand growth [28][30] - The net loss for Q1 2025 was $43.8 million, or $0.92 per share, compared to a net loss of $32.3 million, or $0.87 per share, in the same period in 2024 [30] - Cash, cash equivalents, and marketable securities totaled $200.4 million as of March 31, 2025 [12][30] Business Line Data and Key Metrics Changes - Jelmyto sales for Q1 2025 were $20.3 million, reflecting an 8% year-over-year growth, supported by a 12% increase in underlying demand [11][28] - UGN-102 is expected to target an addressable population of approximately 60,000 patients annually, translating to a market opportunity exceeding $5 billion, significantly larger than the Jelmyto market [10][11] Market Data and Key Metrics Changes - The company anticipates that approximately 70% of UGN-102's business will come from the Medicare population, consistent with the demographics of low-grade intermediate-risk NMIBC patients [34] - The market for UGN-102 is expected to be more accessible than the fragmented UTUC setting, as NMIBC patients are primarily managed by community urologists [10][11] Company Strategy and Development Direction - UroGen aims to transition from a rare disease-focused company to a multi-product organization, with UGN-102 as a primary growth driver alongside Jelmyto [5][9] - The company is expanding its sales force from approximately 50 to over 80 representatives in preparation for the potential launch of UGN-102 [9][24] - UroGen is committed to advancing its pipeline, including next-generation programs and immuno-oncology initiatives, while maintaining a strong balance sheet [12][29] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming ODAC meeting and the PDUFA target date, highlighting the strength of clinical data supporting UGN-102 [6][14] - The company is focused on ensuring timely access for patients and driving reimbursement confidence among providers [22][24] - Management emphasized the importance of UGN-102 as a transformative therapy for patients with recurrent low-grade intermediate-risk NMIBC [22][24] Other Important Information - The FDA has scheduled an ODAC meeting for UGN-102 on May 21, 2025, which is seen as a critical opportunity to present clinical data [6][10] - UroGen has engaged in extensive market research with physicians, indicating strong interest and demand for UGN-102 [55] Q&A Session Summary Question: Breakdown of Medicare and Medicaid exposure for UGN-102 and Jelmyto - Management anticipates that the Medicare population will comprise about 70% of UGN-102's business, aligning with the patient demographic for NMIBC [34] Question: Preparation for the ODAC meeting and expected pushback - Management has conducted mock ODAC panels and feels confident about presenting the clinical data, particularly addressing the single-arm study design of ENVISION [38][40] Question: Current status of the UGN-103 clinical development program - Enrollment for the UGN-103 trial is ongoing, with completion expected by mid-2025 and top-line data anticipated in 2026 [20][69] Question: Expectations regarding the gross-to-net for UGN-102 - Management expects the gross-to-net profile for UGN-102 to be more favorable than Jelmyto, primarily due to a higher proportion of community-based business [100]