UroGen Pharma(US:URGN)2025-11-06 13:02Market Opportunity and Product Approval - Zusduri has an estimated total addressable market opportunity of over $5.0 billion for recurrent low-grade intermediate risk NMIBC, with an annual treatable population of approximately 82,000 in the U.S.[151] - The FDA approved Zusduri on June 12, 2025, as the first and only FDA-approved non-surgical treatment for recurrent low-grade intermediate risk NMIBC[151][164] - Jelmyto, approved on April 15, 2020, is designed for the treatment of low-grade UTUC and has a median duration of response (DOR) of 47.8 months in patients who achieved a complete response[159] Clinical Trial Results - The ATLAS trial showed Zusduri reduced the risk of recurrence, progression, or death by 55% compared to TURBT alone, with a complete response (CR) rate of 64.8% at three months[166] - The ENVISION trial demonstrated a 79.6% CR rate at three months following the initial instillation of Zusduri, meeting its primary endpoint[166] - In the Phase 3 ENVISION trial, Zusduri achieved a 79.6% complete response (CR) rate at three months and 60.8% maintained CR at 12 months among 240 patients[167] - The 18-month duration of response (DOR) for patients who achieved CR at three months was 80.6%, consistent with the 12-month DOR of 82.3%[168] - At 24 months, the DOR for patients who achieved CR at three months was 72.2%[169] - The FDA approved Zusduri on June 12, 2025, based on a CR rate of 78% at three months and 79% maintaining CR at 12 months[173] - The company initiated the Phase 3 UTOPIA trial for UGN-103, enrolling 99 patients globally, with a reported CR rate of 77.8% at three months[178] Financial Performance - Revenue for the three months ended September 30, 2025, was $27.5 million, and for the nine months, it was $72.0 million[190] - Revenue for the three months ended September 30, 2025, was $27.5 million, an increase of $2.3 million from $25.2 million in 2024, primarily due to higher sales volume of Jelmyto and the launch of Zusduri[212] - For the nine months ended September 30, 2025, revenue was $72.0 million, an increase of $6.2 million from $65.8 million in 2024, attributed to increased sales of Jelmyto and the launch of Zusduri[222] Expenses and Losses - Research and development expenses for the nine months ended September 30, 2025, totaled $52.8 million, up from $42.3 million in 2024[193] - Selling and marketing expenses increased to $23.7 million for the three months ended September 30, 2025, from $17.8 million in 2024, reflecting costs related to Zusduri commercial activities and expanded sales force[215] - General and administrative expenses rose to $13.9 million for the three months ended September 30, 2025, compared to $11.2 million in 2024, driven by higher compensation and commercialization support for Zusduri[216] - The net loss for the three months ended September 30, 2025, was $33.3 million, compared to a net loss of $23.7 million in 2024, reflecting an increase in operating loss[210] - Total operating expenses for the three months ended September 30, 2025, were $51.6 million, an increase of $11.3 million from $40.3 million in 2024[210] Cash Flow and Financing - As of September 30, 2025, the company had $127.4 million in cash and cash equivalents and marketable securities, indicating a strong liquidity position[231] - The company reported an accumulated deficit of $933.4 million as of September 30, 2025, and expects to continue incurring losses as it executes its strategy for the commercialization of Zusduri and Jelmyto[243] - The company raised approximately $120.0 million through a Securities Purchase Agreement in July 2023, selling 12,579,156 ordinary shares at a price of $9.54 per share[240] - The company has incurred negative cash flows from operations and expects to finance its cash needs through a combination of equity or debt financings and collaboration arrangements[245] - Future funding requirements will depend on various factors, including clinical trial progress and commercialization activities for Jelmyto and Zusduri[246] Debt and Obligations - The company entered into a loan agreement with Pharmakon for a senior secured term loan of up to $100.0 million, with the first tranche of $75.0 million funded in March 2022 and the second tranche of $25.0 million funded in December 2022[256] - The obligations under the loan agreement are guaranteed by UroGen Pharma Ltd. and secured by substantially all tangible and intangible assets[259] - The company received a one-year extension on the repayment period for all outstanding loans following FDA approval of the NDA for Zusduri, with repayments commencing in Q2 2027[258] Market Coverage and Exclusivity - Medicare patients with supplemental coverage are covered for Jelmyto, with over 150 million lives covered by commercial plans[161] - Jelmyto's new product exclusivity expired on April 15, 2023, but orphan drug exclusivity extends until April 15, 2027[157] - Zusduri is now accessible to over 296 million eligible patients in the U.S., with more than 95% of covered lives having open access[175] Other Financial Metrics - Interest expense on long-term debt increased to $3.4 million for the three months ended September 30, 2025, from $2.7 million in 2024, primarily due to the Pharmakon loan[218] - Interest expense on long-term debt increased to $11.6 million for the nine months ended September 30, 2025, up from $8.6 million in 2024, attributed to the $25.0 million third tranche under the Pharmakon loan funded in September 2024[229] - Net cash provided by investing activities was $33.8 million during the nine months ended September 30, 2025, compared to net cash used of $81.2 million in the same period of 2024, reflecting a net change of $115 million[262] - Net cash provided by financing activities decreased to $8.6 million in the nine months ended September 30, 2025, from $194.5 million in the same period of 2024, a decrease of $185.9 million[263] Currency and Inflation - The company does not currently engage in currency hedging activities to reduce currency exposure but may consider it in the future[267] - The company experienced a 1.2% appreciation of the U.S. dollar against the New Israeli Shekel during 2024, which could affect dollar-denominated results of operations[266] - Inflation has not had a material effect on the company's business or financial condition during the nine months ended September 30, 2025 or 2024[265]