UroGen Pharma (URGN) Q3 2026 earnings summary

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.