UroGen Pharma Ltd. Q3 FY2025 earnings call

Management Statement and Operational Highlights

• ZUSDURI Launch: Encouraging physician enthusiasm and broad market access, but faced logistical/operational challenges. Anticipate acceleration in adoption once the permanent product-specific J-code goes into effect on January 1, 2026. PEFs are growing, and there's high intent to prescribe from physicians.
• JELMYTO: Delivered solid quarter with $25.7M net product revenue, 13% underlying demand growth. Expanded field team offers opportunities for further growth. Next-generation mitomycin program (UGN-103) is on track for NDA submission in the second half of 2026 and potential approval in 2027.
• Clinical Trials and Programs: UGN-103 Phase III UTOPIA study shows 3-month complete response rate consistent with ENVISION trial. UGN-104 Phase III trial initiated. UGN-301 program discontinued, but RTGel platform validated. UGN-501 oncolytic virus IND-enabling studies ongoing, with Phase I trial planned in 2026.
• Commercial Update: ZUSDURI commercial infrastructure operational with ~130 customer-facing professionals. Site readiness expanding, but 45-60 day lag between PEF and patient dosing due to administrative approvals. JELMYTO sees continued demand growth with expanded sales force.

Segment Performance

• JELMYTO: Delivered net product revenue of $25.7 million in Q3 2025, representing a 13% increase in underlying demand revenue compared to the same period in 2024. Contributes significantly to total revenues.
• ZUSDURI: Generated $1.8 million in Q3 2025 revenue. Preliminary demand revenue for October was $4.5 million, more than double the previous 3 months. Patient enrollment forms (PEFs) in Q3 were on track with initial expectations, but conversion to patient dosing was delayed due to logistical/operational challenges and reimbursement concerns with a miscellaneous J-code. PEFs are currently on pace with JELMYTO after 4 months on the market.

Guidance

• Revenue: Expect 2025 JELMYTO net product revenues to be in the range of $94 million to $98 million, representing year-over-year growth of approximately 8% to 12%.
• Operating Expenses: Full year 2025 operating expenses are expected to be in the range of $215 million to $225 million, including noncash share-based compensation expense of $11 million to $14 million.

Risks

• Logistical/Operational Challenges: Delays in converting PEFs to patient dosing due to administrative approvals, reimbursement issues with a miscellaneous J-code.
• Regulatory Uncertainties: Uncertainties around FDA review and approval processes for UGN-103 and other pipeline candidates.
• Market Adoption Hurdles: Slow uptake of ZUSDURI despite positive clinical profile, requiring time to overcome operational and administrative barriers.

Question and Answer

• Q: Specifics on revenue recording timing, 45-60 day lag, outlook for Q4 and beyond A: David Lin explained delays due to benefit investigation, prior authorizations, and site setup. Anticipate improvement in 2026 as practices gain experience.
• Q: Visibility on physicians waiting for permanent J-code, pent-up demand A: David Lin and Elizabeth Barrett noted many physicians and practices waiting for permanent J-code, with patient enrollment forms identified and readiness efforts ongoing for 2026.
• Q: Granular impact of J-code on lag time, UGN-103 FDA requirements A: David Lin discussed improvement in lag time with permanent J-code, but gradual. Mark Schoenberg mentioned FDA will likely require additional longitudinal data, including 12-month sustained response.
• Q: Time to revenue recognition alignment with JELMYTO, cash position and capital needs A: David Lin expects convergence in time to revenue recognition with JELMYTO over 2026. Chris Degnan noted cash position (~$127.4M) supports current plans with confidence in cash to profitability.
• Q: TURBT scheduling, financial incentives, UGN-501 competitive landscape A: David Lin discussed TURBT scheduling (4-6 weeks) and financial economics of ZUSDURI. Mark Schoenberg compared UGN-501 to CG Oncology asset, highlighting similar class and promising mechanism.