UroGen Pharma (URGN) Goldman Sachs 45th Annual Global Healthcare Conference summary

Company overview and technology platform

• Focused on addressing unmet needs in urothelial cancers with RTGel technology, enabling longer dwell time for medicines in the urinary tract.

• RTGel can be combined with various therapies, offering potential expansion beyond urothelial cancers to other urological and adjacent cancers.

• Jelmyto, the first commercial product, targets low-grade upper tract urothelial carcinoma, helping patients avoid kidney loss.

• UGN-102 is in late-stage development for low-grade intermediate-risk non-muscle invasive bladder cancer.

Commercial performance and market dynamics

• Jelmyto launched in 2020, achieving about 12% market penetration with steady double-digit annual growth.

• Market is fragmented, making patient identification challenging, but patient enrollment forms hit record highs in Q1.

• Peak revenue guidance for Jelmyto is $200M–$300M, with growth expected to continue as new care sites are introduced.

• Data generation and real-world evidence have improved adoption, with maintenance therapy showing long-term benefits.

Clinical development and upcoming milestones

• ENVISION trial for UGN-102 is pivotal, with NDA submission planned for September and potential launch at end of Q1 next year.

• ENVISION focuses on recurrent low-grade intermediate-risk bladder cancer, with a prior complete response rate of ~80%.

• Durability data at 12 months is expected to mirror ATLAS trial results, where 66% durability was observed.

• Patient and physician feedback highlight strong preference for UGN-102 over surgery due to convenience and reduced morbidity.