UroGen Pharma (NasdaqGM:URGN) FY Conference Transcript

UroGen Pharma FY Conference Summary Company Overview - Company: UroGen Pharma (NasdaqGM:URGN) - Technology: RTGel technology, a unique polymer combination that forms a soft gel at body temperature, facilitating drug delivery to the bladder and upper urinary tract [2][3] Core Product Insights - Product: Jelmyto, approved for bladder cancer treatment - Market Opportunity: Approximately 60,000 patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (NMIBC) [4] - Unmet Medical Need: High recurrence rates among patients, with 23% experiencing five or more recurrences and 68% having two or more [4] Market Dynamics - Patient Population: Focus on low-grade disease, which is highly recurrent but not life-threatening [6][7] - Surgical Failures: Current treatments often lead to repetitive surgeries, highlighting the need for effective non-surgical options [4][6] Launch and Sales Strategy - Sales Force Expansion: Increased from 40 to 82 representatives to support the launch of UGN-102, with a focus on clinical nurse educators [10][11] - Reimbursement Challenges: Identified as the biggest barrier to adoption; efforts are in place to address this with field reimbursement teams [10][11][19] Early Launch Metrics - Revenue Performance: $1.8 million in Q3 and $4.5 million in October, indicating strong early adoption [14][15] - Patient Enrollment Forms: Early indicators of demand are on par with Jelmyto's performance after five years, suggesting a strong market interest [15][16] Future Growth Potential - J Code Impact: Anticipated positive effects on revenue post-J code implementation in January 2026, with expectations of increased physician confidence and reimbursement facilitation [18][19] - Market Penetration: Projected peak market penetration of over $1 billion, with a conservative estimate of 20% market share [22] Competitive Landscape - First-Mover Advantage: UroGen Pharma is positioned as a primary therapy for low-grade intermediate-risk bladder cancer, differentiating from competitors that require surgery [24][25] - Future Products: Competitors like J&J and CG are developing adjuvant therapies, which may follow surgical interventions, contrasting with UroGen's non-surgical approach [25][26] Pipeline Developments - UGN-103: A new formulation of mitomycin with improved production efficiency, expected to file for NDA in the second half of 2026 [30][31] - UGN-104: Successor product for Jelmyto, anticipated to follow UGN-103 by about a year [34] - Oncolytic Virus (501): Currently in IND enabling studies, with potential applications beyond bladder cancer [35][36] Commercial Synergies - Cross-Promotion: Increased commercial efforts around UGN-102 are expected to drive growth for Jelmyto, as physicians become more familiar with both products [38] Conclusion UroGen Pharma is strategically positioned in the bladder cancer treatment market with innovative technology and a strong pipeline. The company is addressing significant unmet needs in patient care while navigating challenges related to reimbursement and market adoption. The anticipated impact of the J code and the first-mover advantage in the low-grade intermediate-risk segment are expected to drive future growth.