UroGen Pharma Ltd. Q1 FY2026 earnings call

Liz assumed direct oversight of the commercial organization due to the critical importance of Zesturi's relaunch. Zesturi showed strong growth in unique and repeat prescribers, with 256 unique prescribers and 103 repeat prescribers by end of Q1. PEF volume continued to grow. Gelmito has a stable demand profile and is on track for 2026 sales guidance. Pipeline includes UGN-103 with NDA submission planned in second half of 2026, EGN-104 in phase three trial, and UGN501 with IND submission planned in Q2 2026.

In the first quarter of 2026, Zesturi generated $29.2 million in revenue, representing over 100% quarter-over-quarter growth. Gelmito reported revenue of $21.7 million. Zesturi's revenue contribution is approximately 57.25% of the total $51 million revenue, while Gelmito's is approximately 42.35%.

For full year 2026, Gelmito net product revenues are expected to be in the range of $97 to $101 million. No formal sales guidance for Zesturi in 2026. Full-year 2026 operating expenses are expected to be in the range of $240 to $250 million, including non-cash share-based compensation expense of $20 to $24 million.

No specific discussion of risks in detail provided in the transcript

Q: Congrats on the great quarter, with Zesturi exceeding ANCTIVA's demand-driven growth, any updated thoughts on growth for rest of year and analogs?

A: Chris commented they're tracking ahead of ANCTIVA analog, trends consistent, expect continued growth in Q2 and year, no other great analog to share.

Q: Color on TURBTs patients receive prior to Zesturi, reimbursement cost sensitivity?

A: Anecdotally, most initial patients had at least two or three TURBTs, seeing adoption across patient types. Zesturi price is $130K, significantly less than high-priced drugs, with duration of therapy as differentiator.

Q: 2Q demand trends vs 1Q, mix of new prescribers community vs academic?

A: Early Q2 shows continued demand growth, mix shifted to over 50% community setting, academic centers also coming on board.

Q: Change in patients choosing Zesturi over TURBT, long term future of Gelmito?

A: Seeing patients requesting Zesturi, gelmito has low single-digit growth with continued new users.

Q: Timing between PEF and reimbursement for Zesturi, community vs academic receptivity, gelmito future?

A: Time to conversion expected to compress, community to be bigger part of revenue base, gelmito has low single-digit growth with continued new users.

Q: Overlap of Zesturi users with gelmito, UGN 103 development plans?

A: Over 50% of Zesturi users are gelmito users, UGN-103 has NDA submission planned, working on adjuvant trials.

Q: Progress on rollout plan metrics?

A: Very early stages, target 8,500 doctors, currently at early numbers with long way to go