UroGen Pharma (URGN) Conference Call Summary Company Overview - **Company**: UroGen Pharma Ltd. - **Focus**: Development and commercialization of treatments for urothelial cancers, specifically bladder cancer Key Products - **Jelmyto**: Approved for low-grade upper tract urothelial carcinoma - **Market Size**: 7,000 new patients annually in the U.S., with 3,500 historically undergoing kidney removal - **Sales Projection**: Expected to reach $94 to $98 million in 2025, with a potential peak around $150 million [20][21][22] - **Zosduri (UGN-102)**: Targeting low-grade, intermediate-risk non-muscle invasive bladder cancer (NMIBC) - **Market Size**: 80,000 new bladder cancer patients annually, with 60,000 having recurrent low-grade, intermediate-risk disease - **Revenue Potential**: Estimated at $1 billion plus, with a target of capturing 20% of the market [41][42] Core Technology - **RTGel**: A reverse-thermal hydrogel technology that allows drugs to remain in the bladder for extended periods, enhancing treatment efficacy for urothelial cancers [10][11] Clinical Data - **Jelmyto**: High complete response rates with minimal morbidity, offering a less invasive alternative to kidney removal [12][13] - **Zosduri**: - 80% complete response rate in clinical trials, with durability data showing 72% effectiveness at two years [33][34] - Positioned as a primary therapy, distinct from other adjuvant therapies in development [33] Competitive Landscape - **Current Competitors**: Other companies are developing treatments for high-grade bladder cancer but not yet in the intermediate-risk space [35][36] - **Future Competition**: Anticipated as more products enter the market targeting similar patient populations [36] Commercialization Strategy - **J-Code Importance**: Critical for reimbursement and adoption in urology practices, expected to be established by January 1 [44][45] - **Sales Team Expansion**: Increased from 52 to 82 representatives to enhance market presence and support [62] Financial Position - **Cash Reserves**: Ended Q2 with $162 million, sufficient to reach profitability without immediate capital raising [68][69] - **Debt**: $125 million in debt with Pharmakon, indicating a manageable financial structure [69] Future Outlook - **Growth Potential**: Total addressable market for bladder cancer treatments estimated at over $5 billion, with significant opportunities for both Jelmyto and Zosduri [41][42] - **Long-term Strategy**: Plans to expand into other urothelial cancers and explore additional business development opportunities [64][66] Additional Insights - **Patient Preference**: 90% of patients preferred non-surgical Zosduri treatment over traditional TURBT procedures, indicating strong market demand [38] - **Operational Readiness**: Focus on activating sites and training staff to ensure smooth drug rollout post-J-code [52][53] This summary encapsulates the key points discussed during the UroGen Pharma conference call, highlighting the company's strategic direction, product offerings, and market potential.

Financial Data and Key Metrics Changes - UroGen reported net product revenues of $20.3 million for Q1 2025, an 8% year-over-year increase from $18.8 million in Q1 2024, driven by a 12% underlying demand growth [28][30] - The net loss for Q1 2025 was $43.8 million, or $0.92 per share, compared to a net loss of $32.3 million, or $0.87 per share, in the same period in 2024 [30] - Cash, cash equivalents, and marketable securities totaled $200.4 million as of March 31, 2025 [12][30] Business Line Data and Key Metrics Changes - Jelmyto sales for Q1 2025 were $20.3 million, reflecting an 8% year-over-year growth, supported by a 12% increase in underlying demand [11][28] - UGN-102 is expected to target an addressable population of approximately 60,000 patients annually, translating to a market opportunity exceeding $5 billion, significantly larger than the Jelmyto market [10][11] Market Data and Key Metrics Changes - The company anticipates that approximately 70% of UGN-102's business will come from the Medicare population, consistent with the demographics of low-grade intermediate-risk NMIBC patients [34] - The market for UGN-102 is expected to be more accessible than the fragmented UTUC setting, as NMIBC patients are primarily managed by community urologists [10][11] Company Strategy and Development Direction - UroGen aims to transition from a rare disease-focused company to a multi-product organization, with UGN-102 as a primary growth driver alongside Jelmyto [5][9] - The company is expanding its sales force from approximately 50 to over 80 representatives in preparation for the potential launch of UGN-102 [9][24] - UroGen is committed to advancing its pipeline, including next-generation programs and immuno-oncology initiatives, while maintaining a strong balance sheet [12][29] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming ODAC meeting and the PDUFA target date, highlighting the strength of clinical data supporting UGN-102 [6][14] - The company is focused on ensuring timely access for patients and driving reimbursement confidence among providers [22][24] - Management emphasized the importance of UGN-102 as a transformative therapy for patients with recurrent low-grade intermediate-risk NMIBC [22][24] Other Important Information - The FDA has scheduled an ODAC meeting for UGN-102 on May 21, 2025, which is seen as a critical opportunity to present clinical data [6][10] - UroGen has engaged in extensive market research with physicians, indicating strong interest and demand for UGN-102 [55] Q&A Session Summary Question: Breakdown of Medicare and Medicaid exposure for UGN-102 and Jelmyto - Management anticipates that the Medicare population will comprise about 70% of UGN-102's business, aligning with the patient demographic for NMIBC [34] Question: Preparation for the ODAC meeting and expected pushback - Management has conducted mock ODAC panels and feels confident about presenting the clinical data, particularly addressing the single-arm study design of ENVISION [38][40] Question: Current status of the UGN-103 clinical development program - Enrollment for the UGN-103 trial is ongoing, with completion expected by mid-2025 and top-line data anticipated in 2026 [20][69] Question: Expectations regarding the gross-to-net for UGN-102 - Management expects the gross-to-net profile for UGN-102 to be more favorable than Jelmyto, primarily due to a higher proportion of community-based business [100]