UroGen Pharma (URGN) Q4 2025 earnings summary

Executive summary

• ZUSDURI launched for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer, generating $15.8 million in 2025 revenue, with accelerated adoption following permanent J-code implementation in January 2026.

• JELMYTO net product revenue reached $94 million in 2025, reflecting steady demand and 7% year-over-year growth in a mature market.

• Pipeline progress includes UGN-103 (next-gen ZUSDURI) with strong phase III results and NDA submission planned for 2H 2026, and UGN-104 advancing in phase III.

• Refinancing of debt facility with Pharmakon Advisors provides up to $250 million at a fixed 8.25% rate, enhancing financial flexibility and supporting ongoing operations.

Financial highlights

• Total 2025 revenues were $109.8 million, up 21% year-over-year from $90.4 million in 2024, driven by ZUSDURI launch and JELMYTO growth.

• R&D expenses rose to $67.1 million in 2025, mainly due to ZUSDURI manufacturing and pipeline development.

• SG&A expenses increased to $155.1 million, reflecting commercial expansion for ZUSDURI.

• Net loss widened to $153.5 million ($3.19/share) from $126.9 million ($2.96/share) in 2024.

• Cash, equivalents, and marketable securities totaled $120.5 million at year-end 2025.

Outlook and guidance

• JELMYTO 2026 net product revenue expected between $97 million and $101 million, implying 3%-7% growth.

• 2026 operating expenses projected at $240-$250 million, including $20-$24 million in non-cash share-based compensation.

• No formal 2026 sales guidance for ZUSDURI due to early launch phase; guidance may be provided after two quarters of steady-state demand.

• ZUSDURI peak sales potential estimated at over $1 billion, with a four-year ramp to peak expected.

• NDA submission for UGN-103 planned for the second half of 2026, with potential FDA approval in 2027.