UroGen Pharma (URGN -7.90%), a uro-oncology company, reported second quarter 2025 earnings on August 7, 2025. The highlight was the FDA approval and launch of ZUSDURI (mitomycin) for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer, a major expansion beyond its existing JELMYTO (mitomycin) product. Net product revenue (GAAP) reached $24.2 million, beating the Street’s $23.1 million GAAP target. However, the company posted a net loss per share of ($1.05) under GAAP, mainly due to higher selling, general and administrative expenses as the ZUSDURI commercialization effort scaled up. The quarter marked strong commercial execution and pipeline progress, though near-term profitability and cash flow remain pressured by elevated investment in growth initiatives and a rapid cash burn rate.
| Metric | Q2 2025 | Q2 2025 Estimate | Q2 2024 | Y/Y Change |
|---|---|---|---|---|
| EPS (GAAP) | ($1.05) | ($0.83) | ($0.82) | (28.0 %) |
| Revenue (GAAP) | $24.2 million | $23.1 million | $21.8 million | 11.0 % |
| Research & Development Expenses | $18.9 million | $15.4 million | 22.7 % | |
| Selling, General & Administrative Expenses | $43.2 million | $30.1 million | 43.5 % | |
| Cash, Cash Equivalents & Marketable Securities | $161.6 million(as of June 30, 2025) | N/A |
Source: Analyst estimates provided by FactSet. Management expectations based on management's guidance, as provided in Q1 2025 earnings report.
Company Overview and Recent Priorities
UroGen Pharma develops and commercializes therapies for urologic cancers using its proprietary RTGel technology. RTGel is a hydrogel that transforms from liquid to gel at body temperature, enabling long-lasting delivery of drugs directly to the urinary tract. With JELMYTO (mitomycin) already approved for treatment of low-grade upper tract urothelial carcinoma (a rare, non-invasive urinary tract cancer) and now ZUSDURI for bladder cancer, the company’s focus is expanding to address larger patient populations.
Recently, the company has concentrated on commercial launches, regulatory milestones, and advancing clinical pipeline programs. Its most important growth factors are successful market penetration of new products (especially ZUSDURI), continued advancement of RTGel-based therapies, diligent pipeline execution, robust payer reimbursement, and securing intellectual property protection to maintain exclusivity for approved drugs.
Quarterly Review: Key Developments and Financial Performance
Revenue (GAAP) exceeded estimates, driven by positive momentum for JELMYTO, the company’s mitomycin therapy for low-grade upper tract urothelial carcinoma. Net product sales grew 11% year over year, reflecting both a 7% increase in demand and more favorable pricing. This registry collects data on treatment, outcomes, and safety from routine use of JELMYTO.
An important milestone was the FDA approval of ZUSDURI (mitomycin) for intravesical solution on June 12, 2025, which became the first and only medicine approved for adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer. The drug secured approval on June 12, 2025, following positive results in pivotal trials. The phase 3 ENVISION study showed a 72.2% probability of remaining in complete response at 24 months after achieving a complete response at three months, according to Kaplan-Meier estimates, and the median duration of response in a separate study surpassed three years (median DOR was approximately 3.5 years by Kaplan-Meier estimate in the long-term extension of the Phase 2b OPTIMA II trial). ZUSDURI’s commercial launch is underway, targeting a market opportunity of over $5 billion, nearly 10 times larger than the JELMYTO market.
To support the larger opportunity presented by ZUSDURI, the company expanded commercial operations, including hiring sales representatives and engaging major payers to support future reimbursement. This drove a sharp increase in operating expenses, with selling, general, and administrative (SG&A) costs rising 43.5% compared to Q2 2024, to $43.2 million. Research and development (R&D) expenses also jumped to $18.9 million, a 22.7% increase from Q2 2024, as the company invested further in next-generation products and ongoing clinical trials.
Profitability metrics were pressured by these investments. Net loss (GAAP) widened to $49.9 million—about 50% larger than Q2 2024.—resulting in a net loss per share of ($1.05) (GAAP). The company’s balance sheet also saw a notable decline in cash and marketable securities to $161.6 million as of June 30, 2025, down by more than $80 million in cash reserves over the six months from December 31, 2024, to June 30, 2025. Shareholders’ deficit deepened, and total liabilities rose slightly. The company now operates with less than two years of cash on hand at the current rate of spending, absent revenue acceleration or additional funding.
Pipeline programs continued to move forward. The UGN-103 phase 3 UTOPIA trial for a next-generation mitomycin product in bladder cancer completed enrollment as of August 2025, and the UGN-104 phase 3 trial for an expanded JELMYTO-like product has started. The immuno-oncology candidate UGN-301 (zalifrelimab), an antibody targeting CTLA4, completed dose escalation studies, with updated data expected later in 2025 to determine further clinical development. No dividend was paid or adjusted in the period.
Looking Ahead: Guidance and Investor Focus
Management maintained its full-year 2025 net product revenue guidance for JELMYTO at $94–98 million, projecting 8–12% year-over-year growth in JELMYTO net product revenue compared to $87.4 million in 2024, excluding $3.0 million in CREATES Act sales. The company also maintained its operating expense outlook at $215–225 million for full-year 2025, including non-cash expenses. UroGen expects continued high investment in ZUSDURI’s commercial rollout and further clinical activities for its pipeline candidates. Leadership did not provide forward guidance for ZUSDURI sales yet, reflecting early launch timing and the need for several quarters of data.
Investors will likely pay close attention to prescription trends for ZUSDURI and JELMYTO, gross-to-net revenue rates as payer and channel mix evolve, and the pace of cash usage. Product adoption—especially in community settings—payer coverage, and any additional data supporting ZUSDURI’s efficacy or safety will serve as key markers for the company’s execution in the quarters ahead. URGN does not currently pay a dividend.
Revenue and net income presented using U.S. generally accepted accounting principles (GAAP) unless otherwise noted.
