UroGen Pharma Holdings Inc. reported second-quarter Zusduri revenue of $50.4 million, a 73% increase from the prior quarter, during its appearance at the H.C. Wainwright biotech conference.
Management attributed the growth entirely to demand rather than pricing changes or channel inventory buildup, noting that gross-to-net pricing remained consistent.
The drug's permanent J-code, effective January 1, has become a key adoption trigger by giving physicians confidence in reimbursement. About 60% of the business came from hospital and academic settings in 2023, but community practices accounted for 55% in the second quarter. Community practices are expected to represent roughly 65% of business at peak, where about 70% of eligible patients are treated.
Physician adoption remains early. Of an estimated 6,500 core target urologists, only 450 have prescribed Zusduri to date. Approximately 60,000 patients annually are eligible for treatment. Of those who prescribed the drug, 45%—204 physicians—are repeat prescribers. Among physicians who used Zusduri in the ATU study, 100% said they would use it again.
Clinical durability data showed a 36-month response duration with no median recurrence reached, management said. About half of these patients would typically have recurred within the first year following surgery.
Jelmyto, UroGen's earlier product, is expected to post low single-digit year-over-year growth. Clinical trial competition is estimated to divert $2 million to $3 million in revenue from Jelmyto.
UroGen did not set formal revenue guidance, saying it will wait until 2027 after seeing a full year of permanent J-code data. The stock traded at $42.07, up 136% over the past year, with a market capitalization of $2.06 billion. Analyst consensus rate is 1.38, with price targets ranging from $48 to $75.
In the pipeline, UroGen expects a PDUFA date of June 2025 for UGN-103, an improved formulation of Zusduri. The company received a notice of allowance for a new patent extending protection to 2044. Twelve-month durability data for UGN-103 is expected late 2024 or early 2025, and management reiterated the drug will not launch without a permanent J-code.
UGN-104 for intermediate-risk non-muscle invasive bladder cancer is expected to reach full patient enrollment in 2024, with an FDA filing targeted for early 2029 and approval by year-end, following a six-month data filing pathway permitted by regulators.
UroGen also outlined plans for a basket study of oncolytic virus candidate UGN-501 across multiple solid tumors, slated to begin in 2025. A new frontline study for Zusduri following transurethral resection of bladder tumor is planned for early 2025, supported by ATLAS trial data. The products are built on the RTGel reverse-thermal hydrogel platform, originally developed by Israeli chemists.
