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- **ZUSDURI Early Momentum**: $1.8M Q3 sales, $4.5M October demand revenue, with 45-60 day PEF-to-treatment lag. 
- **JELMYTO Growth**: 13% YoY revenue increase, solidifying as standard of care. 
- **Pipeline Progress**: UGN-103 NDA submission planned for H2 2026, UGN-501 Phase I in 2026. 
- **Financial Health**: $127M cash, 2025 JELMYTO guidance of $94-98M, no immediate capital needs. 
- **Strategic Focus**: Permanent J-code launch in January 2026 to accelerate ZUSDURI adoption.

**【CEO Summary Section】**
- ZUSDURI generated $1.8 million in Q3 2025 sales, with preliminary October demand revenue of $4.5 million, reflecting early momentum. 
- Conversion of patient enrollment forms (PEFs) to actual treatments is delayed due to administrative challenges, averaging 45-60 days post-PEF submission. 
- JELMYTO revenue grew 13% YoY to $25.7 million, driven by price and volume growth. 
- The permanent J-code for ZUSDURI will be effective January 1, 2026, expected to accelerate adoption in community settings. 
- UGN-103 Phase III UTOPIA trial showed a 77.8% complete response rate, consistent with ENVISION data, with NDA submission planned for H2 2026. 

**【CFO Financial Commentary】**
- Total Q3 2025 revenue: $27.5 million (JELMYTO: $25.7 million, ZUSDURI: $1.8 million). 
- R&D expenses: $14 million (up $2.6 million YoY due to UTOPIA trial costs). 
- SG&A expenses: $37.6 million (up $8.7 million YoY due to ZUSDURI commercialization). 
- Net loss: $33.3 million, with cash reserves of $127.4 million. 
- 2025 JELMYTO revenue guidance: $94-98 million (8-12% YoY growth). 
- Full-year 2025 operating expenses: $215-225 million. 

**【Q&A Highlights】**
- **J-code Impact**: Community practices are waiting for the permanent J-code, with ~35-40% of ZUSDURI treatments in community settings vs. 60-65% in hospitals. 
- **PEF Conversion**: Weekly PEF volumes match or exceed JELMYTO levels, but 45-60 day lag persists due to formulary approvals. 
- **Pipeline Progress**: UGN-501 oncolytic virus IND-enabling studies underway, with Phase I planned for 2026. 
- **Cash Position**: Sufficient liquidity to support current operations, but no immediate capital needs anticipated. 
- **Long-Term Outlook**: ZUSDURI peak revenue potential of $1 billion, driven by $5 billion addressable market for low-grade NMIBC.

UroGen Pharma Ltd. (URGN) Q3 2025 Earnings Call Transcript

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