UroGen Pharma (NasdaqGM:URGN) 2026 Conference Transcript

UroGen Pharma Conference Call Summary Company Overview - Company: UroGen Pharma (NasdaqGM:URGN) - Founded: In Israel, addressing unmet needs in treating urothelial cancers - Technology: RTGel platform, a reverse thermal gel that allows sustained release of medications in the bladder [5][6] Core Products - Commercial Assets: - Jelmyto: Approved for low-grade upper tract urothelial carcinoma (6,000 patients in the U.S.) - ZUSDURI: Recently approved for low-grade intermediate-risk bladder cancer (60,000 patients in the U.S.) [7][8] Market Opportunity - Patient Demographics: - 60,000 newly diagnosed recurrent patients annually, with 68% having two or more recurrences [16] - 20,000 recurrent newly diagnosed patients, with a significant prevalent pool of low-grade intermediate-risk patients [16] - Unmet Medical Need: Historically, treatment was limited to surgical intervention (TURBT), leading to high recurrence rates [13][14] Product Launch and Performance - ZUSDURI Launch: - Initial revenue of $1.8 million, with October revenue reaching $4.5 million, indicating strong early performance [19] - Permanent J-code introduced in January, expected to accelerate uptake [36] - Market Penetration: - Estimated peak sales potential for ZUSDURI is over $1 billion, requiring only 20% market share to achieve this [37] Clinical Data and Feedback - Efficacy: - ZUSDURI demonstrated an 80% complete response rate, with 80% of those patients maintaining response at 12 months [25] - 90% of patients preferred ZUSDURI over TURBT based on patient-reported outcomes [25] - Physician Feedback: Positive reception from physicians, with many expressing enthusiasm for a non-surgical treatment option [22][25] Competitive Landscape - Positioning: UroGen believes ZUSDURI is the best treatment option due to its non-surgical nature and compelling clinical data [45] - Market Growth: The entry of additional treatments is seen as beneficial for overall market growth, with UroGen confident in its unique offering [44] Future Developments - Next Generation Products: - UGN-103 and UGN-104 are in development for broader applications in bladder cancer [48][51] - UGN-501, an oncolytic virus, is being explored for potential use in other cancers beyond urothelial [52] - Long-term Strategy: UroGen aims to diversify its portfolio while maintaining a focus on urothelial and specialty cancers [52] Financial Guidance - Revenue Guidance: UroGen is not providing specific revenue guidance for the upcoming year but is confident in continued growth based on current trends [39][63] Summary of Key Metrics - ZUSDURI Market Size: 60,000 patients, with a potential peak sales of $1.2 billion at 20% market share [37] - Jelmyto Growth: Continued single-digit growth, with increased physician engagement [55] This summary encapsulates the key points discussed during the UroGen Pharma conference call, highlighting the company's innovative approach to treating urothelial cancers and its strategic market positioning.