UroGen Pharma (URGN) investor relations material

Technology and product overview

• RTGel platform enables longer drug retention in the bladder, addressing a key challenge in urothelial cancer treatment.

• Two main markets targeted: rare low-grade Upper Tract Urothelial Carcinoma (UTUC, 6,000–7,000 US patients) and larger low-grade intermediate-risk non-muscle invasive bladder cancer (NMIBC, ~60,000 US patients).

• Zusduri is the first and only FDA-approved non-surgical therapy for low-grade intermediate-risk NMIBC, launched commercially in late 2023.

• Jelmyto, approved for UTUC, is a more mature product with modest growth expected.

Commercial performance and adoption

• Zusduri generated nearly $30M in Q1 and $50M in Q2, with a steady linear growth trajectory expected.

• Permanent J-code has improved reimbursement confidence and adoption.

• Over 1,400 sites activated and 450–500 unique prescribers, with significant room for expansion.

• Peer-to-peer education and speaker programs are key marketing strategies.

• Physician and patient feedback has been positive, with patients increasingly requesting the therapy.

Market dynamics and differentiation

• Zusduri is unique as a primary non-surgical therapy, while competitors require prior surgery and longer treatment durations.

• Six-week treatment with no maintenance distinguishes Zusduri from other drugs in development.

• Main adoption barrier is shifting urologists from surgical to ablative approaches, but reimbursement and operational support are strong.