Zasturi Early Commercial Traction and Permanent J‑Code
Zasturi generated $15,800,000 in net product revenue in 2025 (Q3 $1.8M; Q4 $14.0M). Permanent, product‑specific J‑code became effective January 1, 2026, and management reported a clear acceleration in key launch indicators (new/repeat prescribers, patient enrollment forms, new patient starts) since that milestone.
Strong Adoption Metrics
As of 12/31/2025 there were 838 activated sites of care, 102 unique prescribers and 32 repeat prescribers. Payer execution covered >95% of covered lives by year‑end 2025. Management reported a shift toward greater community adoption (approximately 50/50 hospital vs. community as of early 2026).
Jelmyto Revenue and 2026 Guidance
Jelmyto generated $94,000,000 in net product revenue in 2025. Management provided 2026 Jelmyto net product revenue guidance of $97,000,000 to $101,000,000, implying ~3% to ~7% year‑over‑year growth.
Company Revenue Growth
Total company revenues were $109,800,000 for 2025, up from $90,400,000 in 2024 — a ~21% year‑over‑year increase driven by Zasturi launch plus increased Jelmyto sales.
Positive Phase 3 Clinical Data and Near‑Term Regulatory Path
UGN‑103 (next‑generation Cysitore) showed a 77.8% complete response (CR) rate at 3 months in the Utopia Phase 3 trial, consistent with ENVISION (approximately 80% CR at 3 months). ENVISION data also show Kaplan‑Meier estimates of ~80% disease‑free at 12 months and ~72% at 24 months. Management plans an NDA submission for UGN‑103 in 2026 with potential approval in 2027.
Pipeline Progress and Multiple Upcoming Milestones
UGN‑104 Phase 3 enrollment expected to complete by 2026. UGN‑501 IND‑enabling work underway with plan to submit IND and start Phase 1 in 2026. Management expects Type C FDA meetings and intends to pursue additional indications (high‑grade and adjuvant settings) for UGN‑103.
Refinancing Strengthens Balance Sheet and Financial Flexibility
Entered a second amended and restated loan agreement providing a $250,000,000 senior secured term loan facility (two tranches). $200,000,000 initial tranche funded at closing (used to refinance prior loan and provide nondilutive capital); second $50,000,000 tranche drawable through 06/30/2027. Interest fixed at 8.25% with principal repayments beginning in 2030. Management stated this enhances financial flexibility to support launch and pipeline execution.
Operational Feedback and Patient/Physician Reception
Anecdotal feedback from early adopters indicated Zasturi integrates smoothly into routine practice (simple outpatient six‑dose regimen, predictable workflow) and patients appreciate a nonsurgical outpatient option. Management reported February 2026 indicators surpassed Jelmyto early launch metrics.