UroGen Pharma(URGN) - 2025 Q3 - Quarterly Results

Financial Performance - UroGen reported total revenues of $27.5 million for Q3 2025, with JELMYTO generating $25.7 million, reflecting a year-over-year growth of approximately 13%[12][8] - ZUSDURI achieved net product revenue of $1.8 million in its first quarter on the market, with preliminary demand revenue for October 2025 estimated at $4.5 million, indicating accelerating growth[12][6] - UroGen reported a net loss of $33.3 million or ($0.69) per share in Q3 2025, compared to a net loss of $23.7 million or ($0.51) per share in Q3 2024[18][26] - The company expects full-year 2025 net product revenues for JELMYTO to be in the range of $94 to $98 million, implying a growth rate of approximately 8% to 12% over 2024[21] Research and Development - R&D expenses for Q3 2025 were $14.0 million, an increase from $11.4 million in Q3 2024, primarily due to costs associated with the UTOPIA trial[13] - The three-month complete response rate for UGN-103 was reported at 77.8% in the Phase 3 UTOPIA trial, consistent with previous results, and the FDA agreed to the NDA submission plan[16][6] - UroGen has made the strategic decision to discontinue the development of UGN-301 after its Phase 1 study, as it did not meet internal benchmarks for advancement[16] - UroGen plans to submit a New Drug Application (NDA) for UGN-103 and is conducting ongoing clinical trials for UGN-104 and UGN-501[46] Commercial Activities - SG&A expenses rose to $37.6 million in Q3 2025, compared to $28.9 million in the same period in 2024, driven by ZUSDURI commercial launch activities[14] - As of October 31, 2025, UroGen reported 592 activated sites of care and 54 unique prescribers for ZUSDURI since its launch on July 1, 2025[7] - Preliminary demand revenue estimate for ZUSDURI in October indicates accelerating commercial uptake and growing physician adoption[46] Product Information - ZUSDURI (mitomycin) is approved for treating adults with recurrent low-grade intermediate risk non-muscle invasive bladder cancer (LG-IR-NMIBC) after ineffective prior surgery[28] - JELMYTO (mitomycin) is indicated for adult patients with low-grade upper tract urothelial cancer (LG-UTUC) and is administered via a ureteral catheter or nephrostomy tube[37] - UroGen's proprietary RTGel technology allows for sustained release of medication, improving therapeutic profiles and potentially enhancing treatment effectiveness[45] - UroGen's sustained release technology aims to improve local delivery of complex immunotherapies, enhancing treatment options[46] Safety and Side Effects - The most common side effects of ZUSDURI include increased blood creatinine levels and urinary tract infections[35] - JELMYTO may cause serious side effects, including ureteric obstruction and bone marrow problems, necessitating blood tests prior to treatment[47] Company Overview - UroGen is headquartered in Princeton, NJ, with operations in Israel, focusing on innovative solutions for urothelial and specialty cancers[45]