UroGen Pharma Q2 2025 Earnings Call Transcript

UroGen Pharma reported Q2 2025 earnings, with highlights including ongoing commercialization activities for JELMYTO and ZUSDURI, ongoing and planned clinical trials, and commercial and clinical milestones. The company's President and CEO, Liz Barrett, and other executives discussed market and revenue opportunities, commercialization strategy, and expectations.

UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company focused on innovative solutions for urothelial and specialty cancers, reported its financial results for the second quarter ended June 30, 2025. The company highlighted significant milestones in its commercial portfolio, including the launch of ZUSDURI™, the first and only FDA-approved medication for adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).

Key Financial Highlights:

- Revenue: JELMYTO®, a mitomycin-based treatment for low-grade upper tract urothelial carcinoma (LG-UTUC), generated net product revenue of $24.2 million in Q2 2025, a 11% year-over-year growth driven by underlying demand growth of 7% and price favorability.
- Research & Development Expenses (R&D): R&D expenses increased to $18.9 million, up from $15.4 million in Q2 2024, primarily due to higher manufacturing costs and costs associated with the Phase 3 UTOPIA trial for UGN-103.
- Selling, General and Administrative Expenses (SG&A): SG&A expenses rose to $43.2 million, up from $30.1 million in Q2 2024, driven by ZUSDURI commercial preparation activities and increased commercial operation costs.
- Net Loss: The company reported a net loss of $49.9 million, compared to $33.4 million in Q2 2024.
- Cash and Equivalents: As of June 30, 2025, UroGen reported $161.6 million in cash, cash equivalents, and marketable securities.

Commercial and Clinical Milestones:

- ZUSDURI Launch: On June 12, 2025, the FDA approved ZUSDURI for adults with recurrent LG-IR-NMIBC. The drug demonstrated a probability of remaining in complete response (CR) of 72.2% at 24 months in the Phase 3 ENVISION trial.
- JELMYTO: JELMYTO continues to show strong demand growth, with revenues increasing by 11% year-over-year.
- Pipeline Progress: UroGen reported enrollment completion in the Phase 3 UTOPIA trial for UGN-103, a next-generation mitomycin-based formulation, and initiated a Phase 3 study for UGN-104, another novel mitomycin-based product for LG-UTUC. Additionally, enrollment is complete in the dose escalation phase of UGN-301, an anti-CTLA4 antibody for high-grade non-muscle invasive bladder cancer.

Market and Revenue Opportunities:

UroGen's President and CEO, Liz Barrett, noted that the company is well-positioned to capitalize on the estimated $5 billion+ market opportunity in the uro-oncology space. The commercial team is executing the ZUSDURI launch plan while scaling the organization to address this market.

Conference Call and Webcast:

UroGen will host a live conference call and webcast today at 10:00 AM Eastern Time to review its financial results and provide a general business update. The live webcast can be accessed via the company's website at http://investors.UroGen.com.

References:

[1] https://investors.urogen.com/news-releases/news-release-details/urogen-pharma-expands-commercial-portfolio-launch-zusduritm-and