UroGen Pharma (URGN) investor relations material

Company overview and technology

• Developed RTGel, a reverse thermal gel that enables sustained drug delivery in the urinary tract, addressing the challenge of rapid drug voiding in urothelial cancers.

• Two commercial products use mitomycin with RTGel: Jelmyto for upper tract and ZUSDURI for bladder cancer.

• ZUSDURI recently approved for low-grade, intermediate-risk non-muscle invasive bladder cancer, targeting a much larger patient population than Jelmyto.

Market opportunity and launch dynamics

• The addressable market for ZUSDURI is about 60,000 patients annually in the U.S., roughly ten times the size of Jelmyto's market.

• Early launch saw revenue grow from $1.8M in Q3 to $4.5M in October, with similar performance expected in November and December.

• Permanent J-code implemented in January, streamlining reimbursement and accelerating adoption.

• About a third of patients are high unmet need, including those with multiple recurrences, rapid recurrence, or comorbidities.

Clinical data and physician feedback

• ZUSDURI achieved an 80% complete response rate, with 80% of those maintaining response at 12 months and 72% at two years.

• 90% of patients in studies preferred ZUSDURI over surgery (TURBT).

• Physicians and patients express strong enthusiasm for a non-surgical, chemoablative option.

• Most patients receive all six doses, and clinical benefit is widely recognized.