UroGen Pharma FY Conference Summary Company Overview - UroGen Pharma focuses on delivering local medicine to the urothelium, addressing unmet needs in treating urothelial cancers with its innovative RT Gel technology, which transforms from liquid to gel at body temperature [6][7] Key Product: ZUSDURI - ZUSDURI is the first FDA-approved non-surgical option for intermediate-risk non-muscle-invasive bladder cancer (NMIBC) [8] - The product addresses a significant unmet need in treating low-grade, intermediate-risk NMIBC, which has a high recurrence rate [9][10] - Historical treatment involved TURBT procedures, which are invasive and not comprehensive [10][11] Commercial Launch Insights - The commercialization of ZUSDURI is complex, akin to a drug-device combination, requiring operational logistics and physician education [12][13] - The transition from patient enrollment to actual dosing can take up to 60 days, presenting a challenge in revenue recognition [15][17] - Initial sales figures indicated a slower start, but there is optimism about future growth as logistical hurdles are addressed [23][25] Reimbursement Dynamics - Revenue is recognized upon shipment, with a just-in-time inventory model [17][18] - The introduction of a permanent J-code in January is expected to enhance reimbursement confidence among physicians [19][21] - A service warranty is offered to assist physicians with reimbursement processes, although actual usage is anticipated to be low due to positive reimbursement experiences [20] Market Expectations - Approximately 70% of physicians are reportedly waiting for the J-code before using ZUSDURI [21] - Anticipated revenue growth post-J-code is expected to mirror previous experiences with similar products, with a projected 220% increase in revenue within six months [26][27] Competitive Landscape - The entry of competitors into the intermediate-risk space is viewed positively, as it can drive innovation and provide more options for patients [33][34] - UroGen's treatment offers a significant advantage with an 80% complete response rate without the need for surgery, compared to competitors that require surgical intervention [35] Future Developments - UGN-103 and UGN-104 are next-generation formulations with patent protection until 2041, aimed at replacing UGN-102 post-J-code [40][42] - The company is confident in its ability to transition from UGN-102 to UGN-103 without regulatory issues [48][50] Long-term Outlook - The company anticipates continued growth for Jelmyto, its first approved product, as awareness increases with the launch of UGN-102 [51] - 2026 is expected to be a pivotal year for UroGen, with the first two quarters crucial for demonstrating market potential [53]

Core Insights - UroGen Pharma Ltd. reported financial results for Q3 2025, highlighting the launch momentum of ZUSDURI, the first FDA-approved treatment for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer [1][2] - The company expressed optimism about the commercial potential of ZUSDURI, supported by strong physician engagement and broad reimbursement coverage [2][5] Financial Performance - Total revenues for Q3 2025 were $27.5 million, with JELMYTO generating $25.7 million, reflecting a year-over-year growth of approximately 13% [11][7] - ZUSDURI achieved net product revenue of $1.8 million in its first quarter, with preliminary estimates for October 2025 indicating $4.5 million, suggesting accelerating growth [11][6] - As of September 30, 2025, UroGen had $127.4 million in cash, cash equivalents, and marketable securities [17] Product Developments - ZUSDURI received a unique J-Code (J9282) effective January 1, 2026, enhancing patient access through various insurance programs [6] - The Phase 3 UTOPIA trial for UGN-103 reported a complete response rate of 77.8%, with plans to submit an NDA in the second half of 2026 [12][5] - UroGen discontinued the development of UGN-301 due to not meeting internal benchmarks, while continuing with UGN-103 and UGN-104 [12] Research and Development - R&D expenses for Q3 2025 were $14.0 million, driven by costs associated with the UTOPIA trial [13] - The company is focused on next-generation formulations to improve manufacturing efficiencies and extend product lifecycles [2][12] Operational Highlights - UroGen activated 592 sites of care and had 54 unique prescribers for ZUSDURI since its launch [6] - The company anticipates full-year 2025 net product revenues for JELMYTO to be between $94 million and $98 million, indicating an 8% to 12% growth from 2024 [18]

Core Insights - UroGen Pharma Ltd. announced preliminary results from the Phase 3 UTOPIA trial, showing a 77.8% three-month complete response (CR) rate for UGN-103 in patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC) [1][2] - The FDA has agreed that the results from the UTOPIA trial can support a New Drug Application (NDA) submission for UGN-103, marking a significant regulatory milestone for the company [2] Company Overview - UroGen Pharma is focused on developing innovative solutions for urothelial and specialty cancers, utilizing proprietary technologies like RTGel for sustained drug release [7] - The company has developed UGN-103, an improved formulation of mitomycin, which aims to enhance manufacturing and reconstitution processes while providing intellectual property protection until December 2041 [4][2] Clinical Trial Details - The UTOPIA trial is a single-arm, multicenter study involving 99 patients, with a primary endpoint of complete response rate at three months [3] - Patients received 75 mg of UGN-103 via intravesical instillation once weekly for six weeks, with responders entering a follow-up phase to assess durability of response [3] Competitive Landscape - UGN-103 is designed to offer key improvements over ZUSDURI, the first FDA-approved treatment for recurrent LG-IR-NMIBC, including a shorter manufacturing process and simplified reconstitution [2][4] - The U.S. market for LG-IR-NMIBC includes approximately 82,000 new cases annually, with around 59,000 being recurrent cases, indicating a significant patient population for UroGen's products [6]

Core Insights - UroGen Pharma Ltd. has completed patient enrollment in its Phase 3 UTOPIA clinical trial for UGN-103, a next-generation formulation for treating recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC) [1][3] Company Overview - UroGen Pharma is focused on developing innovative solutions for urothelial and specialty cancers, utilizing proprietary technologies like RTGel for sustained drug release [8] - The company aims to provide non-surgical treatment options for bladder cancer patients, with UGN-103 representing a significant advancement in its pipeline [3][5] Clinical Trial Details - The UTOPIA trial enrolled 99 patients globally and is a single-arm, multicenter study evaluating the efficacy and safety of UGN-103 [2][3] - Patients receive 75 mg of UGN-103 via intravesical instillation once weekly for six weeks, with the primary endpoint being the complete response rate at three months [3] Product Information - UGN-103 is designed to improve upon ZUSDURI (mitomycin) by offering a shorter manufacturing process and simplified reconstitution [2][5] - UroGen has received a Notice of Allowance for patent protection of UGN-103, expected to last until December 2041 [4] Market Context - LG-IR-NMIBC affects approximately 82,000 people annually in the U.S., with around 59,000 cases being recurrent [7] - The median age of diagnosis for bladder cancer is 73 years, and up to 70% of NMIBC patients experience at least one recurrence [7]