UroGen Reports Third Quarter 2025 Financial Results as ZUSDURI™ Launch Gains Momentum

Core Insights - UroGen Pharma Ltd. reported financial results for Q3 2025, highlighting the launch momentum of ZUSDURI, the first FDA-approved treatment for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer [1][2] - The company expressed optimism about the commercial potential of ZUSDURI, supported by strong physician engagement and broad reimbursement coverage [2][5] Financial Performance - Total revenues for Q3 2025 were $27.5 million, with JELMYTO generating $25.7 million, reflecting a year-over-year growth of approximately 13% [11][7] - ZUSDURI achieved net product revenue of $1.8 million in its first quarter, with preliminary estimates for October 2025 indicating $4.5 million, suggesting accelerating growth [11][6] - As of September 30, 2025, UroGen had $127.4 million in cash, cash equivalents, and marketable securities [17] Product Developments - ZUSDURI received a unique J-Code (J9282) effective January 1, 2026, enhancing patient access through various insurance programs [6] - The Phase 3 UTOPIA trial for UGN-103 reported a complete response rate of 77.8%, with plans to submit an NDA in the second half of 2026 [12][5] - UroGen discontinued the development of UGN-301 due to not meeting internal benchmarks, while continuing with UGN-103 and UGN-104 [12] Research and Development - R&D expenses for Q3 2025 were $14.0 million, driven by costs associated with the UTOPIA trial [13] - The company is focused on next-generation formulations to improve manufacturing efficiencies and extend product lifecycles [2][12] Operational Highlights - UroGen activated 592 sites of care and had 54 unique prescribers for ZUSDURI since its launch [6] - The company anticipates full-year 2025 net product revenues for JELMYTO to be between $94 million and $98 million, indicating an 8% to 12% growth from 2024 [18]