Release Date: August 07, 2025

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

UroGen Pharma Ltd (NASDAQ:URGN) achieved FDA approval for Zourri, marking a significant milestone for the company and offering a new treatment option for patients with recurrent, low-grade, intermediate-risk, non-muscle invasive bladder cancer.

The company reported strong second-quarter net product revenues of $24.2 million for Gelmio, representing an 11% increase over the same period in 2024.

UroGen Pharma Ltd (NASDAQ:URGN) has expanded its sales force from 50 to 82 representatives, positioning the company to reach 8,500 healthcare providers who treat approximately 90% of the addressable patient population.

The company has a strong balance sheet with $161.6 million in cash equivalents and marketable securities, providing the necessary capital to fund the Zourri launch and support pipeline advancements.

UroGen Pharma Ltd (NASDAQ:URGN) is advancing its clinical pipeline with the fully enrolled phase 3 Utopia trial for UGN 103 and the initiation of a phase 3 trial for UGM 104, indicating progress in their next-generation formulations.

The company faces challenges with reimbursement logistics, particularly before the assignment of a permanent J code, which is crucial for broader adoption of Zourri.

UroGen Pharma Ltd (NASDAQ:URGN) reported a net loss of $49.9 million for the second quarter of 2025, compared to a net loss of $33.4 million in the same period in 2024.

R&D expenses increased by $3.5 million, driven by higher manufacturing costs for Zourri and costs associated with the Phase 3 Utopia trial.

Selling, general, and administrative expenses rose by $13.1 million, primarily due to commercial preparation activities for Zourri.

The company has not yet provided specific metrics or guidance for Zourri’s early launch phase, making it difficult to assess short-term performance and market penetration.

Q: Can you provide any metrics or qualitative insights on the early launch of Zourri, such as script rates or perceived demand? A: Liz Barrett, CEO, and David Lynn, Chief Commercial Officer, noted that while it’s too early to provide specific metrics, there is significant excitement among healthcare providers and payers. The main hurdle is reimbursement, but there is a strong interest from doctors who have multiple patients ready for treatment once reimbursement logistics are resolved. The team is optimistic about the uptake and expects acceleration post-J code assignment in 2026.

Story Continues

Q: How is the reimbursement process going for Zourri using the miscellaneous code, and how does it compare to the launch of Jelmyto? A: David Lynn explained that they are focusing on educating around 2000 providers on the claims and billing process, similar to the Jelmyto launch. While it’s too early to see paid claims, the practices feel assured about the process. Liz Barrett added that the main barrier is reimbursement, not clinical use, and they expect significant uptake once reimbursement is streamlined.

Q: With the Utopia trial for UGN 103 fully enrolled, have there been any discussions with regulators about its potential approval? A: Liz Barrett stated that they have not yet interacted with the FDA due to insufficient data but plan to do so by the end of the year. The goal is to replicate the Envision study to avoid introducing biases, and they expect the FDA to accept the study based on previous communications.

Q: How does the early adoption strategy for Zourri differ between community and academic settings? A: David Lynn mentioned that the majority of early adopters are in the community setting, with some in institutional settings. They are helping practices identify sites of care, often in hospital outpatient settings, to gain initial experience with Zourri.

Q: Are there any expected advantages of UGN 103 over Zourri in terms of safety, tolerability, or administration? A: Dr. Mark Schoenberg, Chief Medical Officer, indicated that they do not expect any significant changes in the clinical profile of UGN 103 compared to Zourri. The formulation changes are related to solubility and reconstitution, and they will share data later in the year.

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

This article first appeared on GuruFocus.