Urogen Pharma Stock Earnings Reports

Key points for investors:

- ZUSDURI launch: Initial uptake slower than management expected due to operational and reimbursement logistics, including use of a temporary miscellaneous J-code. Q3 ZUSDURI sales were $1.8M; management reports a preliminary October demand revenue estimate of $4.5M (more than double the prior 3 months). Patient enrollment forms (PEFs) are growing and are currently on pace with JELMYTO after four months on market, but there is a 45–60 day average lag from PEF to dosing driven by prior authorizations, site activation and hospital formulary approvals. The company expects meaningful acceleration once the permanent product-specific J-code becomes effective January 1, 2026 and expects conversion times to narrow over 2026 toward JELMYTO-like timelines.

- Market opportunity and commercial execution: Management reiterates ZUSDURI addresses an estimated $5B annual market and targets >$1B peak revenue long-term. Commercial infrastructure is in place (82 reps for ZUSDURI + JELMYTO; ~130 customer-facing staff; ~600 activated sites). Early usage skews hospital-outpatient (~60–65%) vs community (~35–40%), with community adoption expected to increase after the permanent J-code.

- JELMYTO performance: Q3 JELMYTO net product revenue $25.7M (13% underlying growth YoY excluding CREATES sales). Management says JELMYTO adoption remains steady and the expanded sales force should drive additional growth.

- Pipeline progress: UGN-103 (next-generation mitomycin, low-grade intermediate-risk NMIBC): Phase III UTOPIA enrollment complete; 3-month complete response ~77.8% consistent with ENVISION; FDA agreed UTOPIA can support an NDA; planned NDA submission in H2 2026 with potential approval in 2027. UGN-104 (mitomycin UTUC) Phase III initiated. UGN-301 (local anti-CTLA-4) discontinued due to profile not warranting Phase II, but validated RTGel delivery of immunotherapies. UGN-501 (oncolytic virus) IND-enabling activities ongoing; Phase I planned in 2026 for recurrent NMIBC.

- Financials and guidance: Total revenue Q3 2025 $27.5M (JELMYTO $25.7M; ZUSDURI $1.8M). Net loss Q3 $33.3M ($0.69/share). Cash, cash equivalents and marketable securities $127.4M as of 9/30/25. Guidance provided for JELMYTO 2025 net product revenues of $94M–$98M (implies ~8–12% growth YoY on demand basis). Full-year 2025 operating expenses unchanged at $215M–$225M (including $11M–$14M stock comp). Management believes current cash position is sufficient to fund core priorities and the company remains disciplined on capital needs.

- Key operational expectations: Management expects the J-code change to simplify reimbursement (electronic claims) and shorten remittance times, reduce administrative burden, and unlock community practice adoption—leading to accelerating conversion of PEFs to dosed patients across 2026. Management does not expect instantaneous change on Jan 1, 2026 but steady improvement through the first half of 2026.