UroGen Pharma Ltd. (Nasdaq: URGN) reported its financial results for the year ended December 31, 2025, showcasing a revenue increase driven by its approved products, Jelmyto and Zusduri. The company's total revenue reached $109.8 million, compared to $90.4 million in 2024, reflecting a growth of $19.4 million. This increase was primarily attributed to the sales volume of Zusduri, which was launched in the second quarter of 2025, and increased sales of Jelmyto. Despite the revenue growth, UroGen Pharma reported a net loss of $153.5 million for 2025, compared to a net loss of $126.9 million in the previous year.
The company's cost of revenue also increased to $12.4 million in 2025 from $8.9 million in 2024, primarily due to the increased sales volume of Jelmyto, a higher unit cost for Jelmyto, increased shipping and warehousing expenses, and an inventory write-off. Research and development expenses rose to $67.1 million in 2025 from $57.1 million in 2024, driven by higher manufacturing costs for Zusduri, costs associated with the Phase 3 UTOPIA trial for UGN-103 and the Phase 3 trial for UGN-104, and the acquisition of assets from IconOVir. Selling and marketing expenses increased to $99.1 million in 2025 from $75.2 million in 2024, primarily due to Zusduri commercial activities and an expansion of the sales force.
Key operational developments for UroGen Pharma in 2025 included the FDA approval and subsequent commercial launch of Zusduri for recurrent low-grade intermediate risk NMIBC. The company also completed patient enrollment in the Phase 3 UTOPIA trial for UGN-103 and initiated a Phase 3 trial for UGN-104. In February 2025, UroGen acquired ICVB-1042 (now known as UGN-501), a next-generation investigational oncolytic virus, to enhance its immuno-uro-oncology pipeline. The company discontinued development of UGN-301 based on strategic priorities.
Looking ahead, UroGen Pharma anticipates submitting an NDA for UGN-103 in the second half of 2026, with potential FDA approval in 2027. The company expects to complete enrollment in the Phase 3 trial of UGN-104 by the end of 2026 and plans to initiate a Phase 1 clinical study for UGN-501 by the end of 2026. As of December 31, 2025, UroGen Pharma had cash, cash equivalents, and marketable securities totaling $120.5 million. The company believes these resources, along with projected cash inflows, will be sufficient to fund operations beyond one year from the issuance of the financial statements.
About UroGen Pharma Ltd.
UroGen Pharma develops innovative, proprietary drug delivery solutions for uro-oncology and urological cancers. Its core technology, RTGel, enables sustained, targeted release of existing and investigational drugs like mitomycin, aiming to improve efficacy and reduce invasiveness of treatments for conditions such as UTUC and bladder cancer. The company focuses on minimally invasive therapies, leveraging its strong IP portfolio and regulatory expertise to address unmet medical needs in the urinary tract.
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