UroGen Pharma Expands Commercial Portfolio with Launch of ZUSDURI™ and Reports Second Quarter 2025 Financial Results

Core Insights - UroGen Pharma has achieved a significant milestone with the FDA approval of ZUSDURI for treating adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC), marking its transition into a multi-product uro-oncology company [2][7] - The company is targeting a market opportunity exceeding $5 billion and is actively executing the launch plan for ZUSDURI while continuing to grow its existing product, JELMYTO [2][6] - UroGen's financial results for Q2 2025 show a net product revenue of $24.2 million for JELMYTO, reflecting an 11% year-over-year growth driven by underlying demand and price favorability [6][10] Financial Performance - JELMYTO net product revenues for Q2 2025 were $24.2 million, up from $21.8 million in Q2 2024, indicating an 11% increase [10] - Research and Development (R&D) expenses for Q2 2025 were $18.9 million, an increase from $15.4 million in Q2 2024, primarily due to higher manufacturing costs and expenses related to the Phase 3 UTOPIA trial [11] - Selling, General and Administrative (SG&A) expenses rose to $43.2 million in Q2 2025 from $30.1 million in Q2 2024, driven by commercial preparation activities for ZUSDURI [12] - The company reported a net loss of $49.9 million in Q2 2025, compared to a net loss of $33.4 million in the same period in 2024 [15][20] Product Development and Pipeline - Enrollment is complete for the Phase 3 UTOPIA trial of UGN-103, a next-generation mitomycin formulation aimed at improving treatment for recurrent LG-IR-NMIBC [5][8] - UroGen is also advancing its immuno-oncology candidates, with ongoing studies for UGN-301, an anti-CTLA4 antibody for high-grade non-muscle invasive bladder cancer [9] - The company is collecting real-world data through the uTRACT Registry to evaluate JELMYTO's use and outcomes in adult patients with upper tract urothelial carcinoma [7] Market Outlook - UroGen maintains its guidance for full-year 2025 net product revenues for JELMYTO in the range of $94 to $98 million, reflecting an expected growth rate of approximately 8% to 12% over 2024 [16] - The company is well-positioned to support the launch of ZUSDURI and advance its strategic initiatives for sustained growth and innovation [2][6]