URGN · UroGen Pharma Ltd.

UroGen Pharma Ltd. delivered a robust Q1 2026 performance, with total revenue surging 152% year-over-year to $51.0 million, primarily propelled by the commercial launch of ZUSDURI, which posted $29.2 million in net product revenue—more than doubling from the prior quarter amid broader adoption following the permanent J Code effective January 1, 2026. This reflects accelerating prescriber trends, with 972 activated sites, 256 unique prescribers, and 103 repeat prescribers as of March 31, 2026, signaling growing clinical confidence in ZUSDURI as a non-surgical option for recurrent LG-IR-NMIBC. JELMYTO contributed $21.7 million, up 7% from Q1 2025's $20.3 million, underscoring steady demand in LG-UTUC. Gross profit expanded to $46.8 million from $17.9 million, though SG&A expenses rose to $51.5 million from $35.0 million due to ZUSDURI commercialization, sales force expansion, and debt refinancing costs, while R&D declined to $15.6 million from $19.9 million post-FDA approval efficiencies. Operating loss narrowed to $20.3 million from $36.9 million, and net loss improved to $23.6 million ($0.47 per share) from $43.8 million ($0.92 per share), aided by a $4.8 million income tax benefit. Balance sheet strengthened with cash at $140.3 million versus $120.5 million at year-end 2025, bolstered by a $200 million first-tranche debt facility from Pharmakon Advisors at 8.25% interest, refinancing prior debt and providing non-dilutive capital. Guidance reaffirms JELMYTO at $97-101 million for 2026 (3-7% growth over 2025's $94 million) and operating expenses at $240-250 million. Pipeline progress includes UGN-103 NDA submission planned for H2 2026, six-month durability data mid-2026, ongoing UGN-104 Phase 3 enrollment by year-end, and UGN-501 IND in Q2 2026. CEO Liz Barrett highlighted launch momentum validating the commercial model and blockbuster potential, positioning UroGen for uro-oncology leadership.