UroGen Pharma Reports $126.8 Million Net Loss for 2024, Revenue Increases to $90.4 Million

UroGen Pharma Ltd. reported a net loss of $126.8 million for the year ended December 31, 2024, compared to a net loss of $102.2 million in 2023. Revenue increased by $7.7 million to $90.4 million in 2024, primarily driven by increased Jelmyto sales, partially offset by a decrease in CREATES Act sales. Cost of revenue decreased by $0.5 million to $8.9 million due to lower shipping, warehousing costs, and a decrease in Jelmyto unit cost. Research and development expenses increased by $11.5 million to $57.1 million, primarily due to higher manufacturing costs and regulatory expenses related to UGN-102.

Selling and marketing expenses rose significantly by $20.5 million to $75.2 million, largely attributed to UGN-102 commercial preparation activities and increased operational costs. General and administrative expenses increased by $7.3 million to $45.9 million, primarily due to higher compensation and UGN-102-related costs. The company's cash and cash equivalents and marketable securities totaled $241.7 million as of December 31, 2024. Significant financing activities included proceeds from ordinary share sales under the ATM Sales Agreement and a public offering, as well as debt financing.

Key operational developments included the completion of the Phase 3 ENVISION trial for UGN-102, which met its primary endpoint, showing a 79.6% complete response rate at three months. Updated 18-month data showed an 80.6% durable response rate. The company also completed a Phase 3b study demonstrating the feasibility of home administration of UGN-102. In October 2024, the FDA accepted the NDA for UGN-102, assigning a PDUFA goal date of June 13, 2025. The company also initiated a Phase 3 trial for UGN-103 and plans to initiate a Phase 3 trial for UGN-104 in the first half of 2025. A Phase 1 trial for UGN-301 is ongoing. The company's customer-facing team comprises approximately 100 representatives.

The company's Jelmyto product, approved in April 2020, saw new product exclusivity expire in April 2023, but orphan drug exclusivity extends until April 2027. A Paragraph IV Certification Notice Letter was received from Teva Pharmaceuticals in February 2024, leading to a lawsuit alleging patent infringement. The company has 235 employees worldwide as of January 31, 2025. The company's outlook includes continued efforts to establish Jelmyto as standard of care, advance UGN-102 towards approval, and expand its uro-oncology pipeline. The company anticipates continued losses for the foreseeable future and plans to finance operations through a combination of product sales, equity and debt financings, and collaborations. The company's financial statements include a discussion of critical accounting estimates, including revenue recognition, share-based compensation, and income taxes.