UroGen Pharma (NasdaqGM:URGN) FY Conference Transcript

UroGen Pharma FY Conference Summary Company Overview - UroGen Pharma Ltd. is a leading biotech company focused on urothelial cancer, traded on NASDAQ under the ticker URGN [7][9] - The company was founded in 2004, based on research from Israel, and developed RTGel technology for drug delivery in the urinary tract [8][9] Key Products and Market Opportunities - Jelmyto (mitomycin): Launched in 2020 for low-grade urothelial cancer, targeting a patient population of approximately 6,000-7,000 annually in the U.S. [9][13] - Zosduri (UGN-102, mitomycin): Approved by the FDA on June 12, 2025, for recurrent low-grade intermediate risk non-muscle invasive bladder cancer, targeting about 60,000 patients annually in the U.S. [10][11][13] - The market opportunity for Zosduri is estimated to exceed $5 billion, assuming a treatment cost of $100,000 per patient [13] Launch and Sales Strategy - UroGen has expanded its sales force from 52 to 82 representatives to target 8,500 physicians, covering 90% of the Zosduri opportunity [14][15] - The company provides comprehensive support for physicians, including reimbursement assistance and training for product administration [15][16] - Initial enthusiasm from the physician community is high, with 90% of patients preferring outpatient treatment over traditional surgical procedures [21][22] Clinical Data and Patient Outcomes - Zosduri has shown promising clinical results, with 80% of patients achieving complete response at three months and 72% maintaining this response at 24 months [16][17] - The product is the first FDA-approved non-surgical therapy for this patient population, representing a significant shift in treatment paradigms [21][22] Pipeline and Future Developments - UroGen is advancing its pipeline with UGN-103 and UGN-104, both in phase 3 trials, with UGN-103 expected to submit an NDA by the end of 2026 [27][29][32] - The company is also exploring a multi-drug immunotherapy program and an oncolytic virus (UGN-501) for potential use in bladder cancer and other cancers [32][33] Financial Position - UroGen reported cash reserves of $162 million as of June, sufficient to fund the Zosduri launch and support a path to profitability [34] Conclusion - UroGen Pharma is positioned for growth with its innovative therapies in the urothelial cancer space, a strong pipeline, and a solid financial foundation to support its strategic initiatives [34]