earnings
confidence high
sentiment positive
materiality 0.65
UroGen Q3: ZUSDURI rev $1.8M, Oct estimate $4.5M; JELMYTO +13% YoY; net loss $33.3M
UroGen Pharma Ltd.
- ZUSDURI achieved net product revenue of $1.8M in Q3; October 2025 preliminary demand revenue estimate of $4.5M, with 592 activated sites and 54 prescribers since July launch.
- JELMYTO net revenue $25.7M (+13% YoY underlying demand growth); full-year JELMYTO guidance unchanged at $94-98M, op expenses $215-225M.
- Net loss of $33.3M ($0.69/share) vs $23.7M ($0.51) in Q3 2024; cash $127.4M as of Sept 30, 2025.
- UGN-103 Phase 3 UTOPIA shows 77.8% CRR; FDA agrees to NDA submission plan; NDA expected H2 2026 with potential approval 2027.
- UGN-301 (zalifrelimab) development discontinued; UroGen terminates license with Agenus.