UroGen Pharma(URGN) - 2025 Q4 - Annual Report

Market Opportunity - 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.[511] Clinical Trial Results - The CR rate for Zusduri in the ENVISION trial was 79.6% at three months, with 60.8% of all enrolled patients in CR at 12 months[526] - Jelmyto achieved a CR rate of 58% in the Olympus trial, with a durability of response estimated at 81.8% at 12 months[518] - The ENVISION trial demonstrated a 72.2% DOR at 24 months for patients who achieved CR at three months[528] - In the Phase 3 ENVISION trial, 78% of patients achieved complete response (CR) at three months, with 79% of those maintaining CR at 12 months[531] - The Phase 3b study showed that 75% of patients achieved CR after home administration of Zusduri, with six out of eight patients completing all six instillations[530] - The median duration of response for patients achieving CR with Jelmyto was not reached, with a median follow-up of 28.1 months[519] - The median duration of response (DOR) for patients in the OPTIMA II trial was 24.2 months, with a median follow-up of 35.8 months[529] - The UTOPIA trial for UGN-103 enrolled 99 patients globally, with a three-month CR rate of 77.8%[536] Regulatory Approvals - The FDA approved Zusduri on June 12, 2025, for the treatment of adults with recurrent low-grade intermediate risk NMIBC[523] - The FDA approved Zusduri on June 12, 2025, based on data from 223 patients in the ENVISION trial[531] - Jelmyto's new product exclusivity expired on April 15, 2023, but Orphan Drug exclusivity extends until April 15, 2027[515] - Medicare has established a permanent J-code for Jelmyto effective January 1, 2021, and granted it a New Technology APC effective October 1, 2023[522] Financial Performance - The company recognized $109.8 million in revenue for the year ended December 31, 2025, compared to $90.4 million in 2024, reflecting a 21.5% increase[551] - Revenue for the year ended December 31, 2025, was $109.8 million, an increase of $19.4 million from $90.4 million in 2024, primarily driven by sales of Zusduri and increased sales of Jelmyto[574] - Net cash used in operating activities increased to $162.4 million for the year ended December 31, 2025, compared to $96.8 million in 2024, primarily due to higher operating expenses[600] - The net loss for the year ended December 31, 2025, was $153.5 million, compared to a net loss of $126.9 million in 2024, reflecting an increase of $26.6 million[573] Research and Development - Research and development expenses totaled $67.1 million in 2025, up from $57.1 million in 2024, indicating a 17.5% increase[555] - The company anticipates continued increases in research and development expenses as clinical programs progress and additional product candidates are developed[558] - Research and development expenses rose to $67.1 million in 2025 from $57.1 million in 2024, an increase of $10.0 million attributed to higher manufacturing costs for Zusduri and costs associated with clinical trials[576] Marketing and Sales - Selling and marketing expenses increased to $99.1 million in 2025 from $75.2 million in 2024, reflecting a rise of $23.9 million due to commercial activities for Zusduri and expanded sales operations[577] - The company initiated a strategic promotion of Zusduri in the U.S. in late June 2025, achieving open access for over 95% of covered lives[533] Cash and Financing - As of December 31, 2025, the company had $120.5 million in cash and cash equivalents and marketable securities[582] - Financing activities provided net cash of $39.9 million in 2025, a decrease of $154.7 million from $194.6 million in 2024, mainly due to reduced proceeds from share issuances[602] - The company expects to finance future cash needs through a combination of equity offerings, debt financings, and collaborations, with no assurance of securing additional financing on favorable terms[605][606] - UroGen Pharma, Inc. entered into a Securities Purchase Agreement on July 26, 2023, resulting in gross proceeds of $120.0 million from the sale of 12,579,156 ordinary shares[593] - The company completed a public offering on June 20, 2024, raising gross proceeds of $107.5 million from the sale of 5,000,000 ordinary shares[594] Tax and Accounting - The company has approximately $626.7 million in carry forward tax losses as of December 31, 2025, and does not expect to pay taxes in Israel until taxable income is generated[571] - Deferred income tax assets and liabilities are determined based on differences between financial reporting and tax bases, using currently enacted tax rates[625] - The company follows a two-step approach in recognizing uncertain tax positions, measuring benefits based on cumulative probability[626] Currency and Inflation - The company experienced a 12.5% depreciation of the U.S. dollar against the NIS during 2025, which could adversely affect dollar-denominated results of operations[629] - Inflation did not have a material effect on the company's business or financial condition during the year ended December 31, 2025[628] - The company does not currently engage in currency hedging activities but may consider using foreign currency forward and swap contracts in the future to manage currency risks[630] Share-Based Compensation - The company recognizes share-based compensation costs over the requisite service period, with performance-based awards expensed when achievement of performance criteria is probable[622] Long-Term Liabilities - The company has a long-term liability recognized under the RTW Transaction, which supports the launch of Jelmyto and development of Zusduri, with future cash payments based on net sales[624] Lease Obligations - The company has a total obligation for future minimum lease payments of $4.1 million and $5.9 million under operating and finance leases, respectively, as of December 31, 2025[611]