UroGen Pharma
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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.
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Q3 2026 earnings summary4 Nov, 2026

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.

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Frequently asked questions

UroGen Pharma Ltd. is a biotechnology company focused on developing and commercializing innovative treatments for urothelial and specialty cancers. The company utilizes its proprietary RTGel technology, a reverse-thermal hydrogel that enhances the therapeutic profiles of existing drugs by providing longer exposure to the urinary tract tissue, making local therapy more effective. The company is headquartered in Princeton, NJ, with operations in Israel, and its shares are listed on the Nasdaq.