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UroGen Pharma (URGN) investor relations material
UroGen Pharma Q3 2026 earnings summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Executive summary
ZUSDURI generated $68.0M in Q3 net product revenue, up 35% QoQ, driving total revenue of $89.0M.
Operating income was $8.3M and net loss narrowed to $1.5M; management expects Q4 profitability and positive cash flow.
FDA accepted the UGN-103 NDA with a June 14, 2027 PDUFA date; UGN-501 dosed its first Phase 1 patient.
Financial highlights
Q3 revenue was $89.0M vs. $27.5M a year earlier; gross profit was $81.5M and operating income was $8.3M vs. a $27.4M loss.
Q3 net loss was $1.5M, or $0.03 per share, vs. $33.3M, or $0.69 per share, in Q3 2025.
Q3 R&D expense was $26.0M vs. $14.0M; SG&A was $47.2M vs. $37.6M, reflecting pipeline development and ZUSDURI launch spending.
Nine-month revenue was $212.4M vs. $72.0M; net loss narrowed to $39.4M from $127.1M.
Nine-month operating cash use was $93.5M vs. $124.1M; cash, cash equivalents and marketable securities totaled $90.5M at September 30, 2026.
Outlook and guidance
FY 2026 JELMYTO net product revenue guidance was reduced to ~$90M from $97M-$101M, reflecting a CMS discard-drug provision true-up and trial-related competition affecting starts.
FY 2026 operating expense guidance remains $260M-$270M, expected toward the upper end, including $20M-$24M of non-cash share-based compensation.
Management expects Q4 QoQ ZUSDURI revenue growth despite holiday seasonality; no full-year ZUSDURI guidance was issued.
Profitability and positive cash flow are anticipated in Q4 2026; management expects available capital resources to fund operations through profitability.
UGN-103 NDA review has a June 14, 2027 PDUFA target; LONGVIEW-HR is planned to start in Q4 2026 and UGN-104 Phase 3 enrollment is expected to finish by year-end 2026 or early 2027.
- Strong demand for Zusduri and advancing pipeline programs signal robust growth prospects.URGN
H.C. Wainwright 28th Annual Global Investment Conference - Zusduri's strong launch and next-gen pipeline position the company for growth and innovation.URGN
12th Annual Cantor Fitzgerald Global Healthcare Conference - ZUSDURI's rapid adoption and robust pipeline position the company for sustained growth.URGN
Wells Fargo 21st Annual Healthcare Conference - First-in-class non-surgical therapies and strong pipeline drive innovation in urothelial cancer care.URGN
Corporate presentation - ZUSDURI revenue rose 73% QoQ as Q2 revenue reached $72.5 million and net loss narrowed.URGN
Q2 2026 - ZUSDURI's rapid uptake and strong clinical data position it for billion-dollar peak sales.URGN
Guggenheim Securities Emerging Outlook: Biotech Summit 2026 - UGN-102 achieved 79.6% CR at 3 months and 82.3% 12-month durability in NMIBC, with low toxicity.URGN
Study Update - All board proposals passed, with strong product progress and no shareholder questions.URGN
AGM 2026 - UGN-102 NDA accepted for June 2025 PDUFA; Jelmyto Q3 sales up, but full-year revenue to miss guidance.URGN
Q3 2024
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