UroGen Pharma(URGN) - 2025 Q2 - Quarterly Results

Overview and Business Highlights UroGen Pharma achieved a transformative milestone with ZUSDURI™ FDA approval and launch, complementing JELMYTO®'s continued growth and advancing its pipeline Executive Summary UroGen Pharma's Q2 2025 results highlight the transformative FDA approval and commercial launch of ZUSDURI™, establishing the company as a multi-product uro-oncology entity alongside JELMYTO®'s continued growth - The FDA approval of ZUSDURI™ for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC) is a transformative milestone, establishing UroGen as a multi-product company[3][8] - The company is executing the commercial launch of ZUSDURI™ to address an estimated market opportunity of over $5 billion[3] Q2 2025 Key Metrics Snapshot | Metric | Value | Growth (YoY) | | :--- | :--- | :--- | | JELMYTO® Net Sales | $24.2 million | 11% | | Cash & Marketable Securities | $161.6 million | N/A | Product Portfolio and Pipeline Update UroGen's commercial portfolio expanded with ZUSDURI™'s launch, complementing JELMYTO®'s growth, while the pipeline advances with next-generation formulations and an immuno-oncology candidate ZUSDURI™ (mitomycin) for intravesical solution ZUSDURI™ received FDA approval as the first and only medication for recurrent LG-IR-NMIBC, supported by strong Phase 3 and Phase 2b clinical data - On June 12, 2025, ZUSDURI™ (formerly UGN-102) was approved by the FDA, becoming the first and only approved medication for adults with recurrent LG-IR-NMIBC[8] - Updated data from the Phase 3 ENVISION trial demonstrated a 72.2% probability of patients remaining in complete response at 24 months[8] - Five-year results from the Phase 2b OPTIMA II trial showed a median duration of response of approximately 3.5 years[8] JELMYTO® (mitomycin) for pyelocalyceal solution JELMYTO® demonstrated 11% year-over-year revenue growth in Q2 2025, driven by increased demand and price favorability, with ongoing real-world data collection JELMYTO® Q2 2025 Performance | Metric | Q2 2025 | Q2 2024 | YoY Growth | | :--- | :--- | :--- | :--- | | Net Product Revenue | $24.2 million | $21.8 million | 11% | - The 11% year-over-year revenue growth was driven by a 7% increase in underlying demand and price favorability[8][11] - The uTRACT Registry, a real-world study of JELMYTO®, is ongoing to provide insights into treatment patterns, long-term outcomes, and patient safety[8] Pipeline Development UroGen's pipeline advanced with completed enrollment for UGN-103's Phase 3 trial, initiation of UGN-104's Phase 3 study, and completed dose escalation for UGN-301 - UGN-103 (Next-gen ZUSDURI): Enrollment is complete in the Phase 3 UTOPIA clinical trial for patients with recurrent LG-IR-NMIBC[6] - UGN-104 (Next-gen JELMYTO): A Phase 3 study to evaluate the safety and efficacy of this next-generation product for LG-UTUC has been initiated[9] - UGN-301 (zalifrelimab): Enrollment is complete in the dose escalation phase for this anti-CTLA4 antibody, showing an acceptable safety profile and observed responses[10] Financial Performance UroGen's Q2 2025 financial performance reflects increased net loss due to ZUSDURI™ launch preparations and R&D investments, alongside JELMYTO® revenue growth and reaffirmed full-year guidance Second Quarter 2025 Financial Results UroGen reported a wider Q2 2025 net loss of $49.9 million, primarily driven by increased SG&A for ZUSDURI™ launch and higher R&D expenses, despite JELMYTO® revenue growth Q2 2025 Financial Summary (vs. Q2 2024) | Metric | Q2 2025 | Q2 2024 | | :--- | :--- | :--- | | JELMYTO Revenue | $24.2 million | $21.8 million | | R&D Expenses | $18.9 million | $15.4 million | | SG&A Expenses | $43.2 million | $30.1 million | | Net Loss | $49.9 million | $33.4 million | | Net Loss per Share | ($1.05) | ($0.82) | | Cash & Equivalents (End of Period) | $161.6 million | N/A | - The increase in SG&A expenses was primarily driven by commercial preparation activities for the ZUSDURI™ launch[13] - Higher R&D expenses were mainly due to increased manufacturing costs and costs associated with the Phase 3 UTOPIA trial for UGN-103[12] Financial Statements The condensed consolidated financial statements present detailed financial position and operational results for the three and six months ended June 30, 2025, compared to 2024 Condensed Consolidated Statements of Operations This statement details the company's revenues, expenses, and net loss for the three and six months ended June 30, 2025, and 2024 Condensed Consolidated Statements of Operations (in thousands, except per share data) | | Three months ended June 30, | Six months ended June 30, | | :--- | :--- | :--- | | | 2025 | 2024 | 2025 | 2024 | | Revenue | $ 24,215 | $ 21,848 | $ 44,469 | $ 40,629 | | Gross profit | 20,665 | 19,619 | 38,589 | 36,672 | | Total operating expenses | 62,113 | 45,458 | 116,951 | 88,251 | | Operating loss | (41,448) | (25,839) | (78,362) | (51,579) | | Net loss | $ (49,940) | $ (33,403) | $ (93,783) | $ (65,689) | | Net loss per share | $ (1.05) | $ (0.82) | $ (1.97) | $ (1.69) | Selected Consolidated Balance Sheets This statement provides a snapshot of the company's assets, liabilities, and equity as of June 30, 2025, and December 31, 2024 Selected Consolidated Balance Sheet Data (in thousands) | | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash, cash equivalents and marketable securities | $ 161,586 | $ 241,707 | | Total assets | $ 208,717 | $ 285,711 | | Total liabilities | $ 302,093 | $ 294,514 | Full-Year 2025 Guidance UroGen reaffirmed its full-year 2025 guidance, projecting JELMYTO® net product revenues between $94 million and $98 million and total operating expenses from $215 million to $225 million Full-Year 2025 Financial Guidance | Metric | Guidance Range | | :--- | :--- | | JELMYTO Net Product Revenues | $94 - $98 million | | Total Operating Expenses | $215 - $225 million | | Non-cash Share-based Compensation | $11 - $14 million | - The revenue guidance implies an 8% to 12% year-over-year growth rate for JELMYTO® over 2024 demand-driven sales[19] Product and Company Information This section provides detailed information on UroGen's commercial products, ZUSDURI™ and JELMYTO®, including their uses, mechanisms, and safety profiles, along with company overview About ZUSDURI™ ZUSDURI™ is an FDA-approved, mitomycin-based intravesical solution utilizing RTGel® technology for recurrent LG-IR-NMIBC, with detailed information on its use and safety - ZUSDURI™ is a prescription medicine for adults with recurrent LG-IR-NMIBC whose previous bladder surgery was not effective[25] - It utilizes UroGen's proprietary RTGel® technology, a sustained-release hydrogel, to enable non-surgical treatment of tumors in an outpatient setting[24] - Important safety information includes contraindication for patients with a perforated bladder and the need for effective contraception for both females and males during and after treatment[26][27][29] About JELMYTO® JELMYTO® is a mitomycin-containing reverse thermal gel approved for LG-UTUC, with details on its mechanism, approved use, and important safety information - JELMYTO® is a prescription medicine for the treatment of adult patients with low-grade Upper Tract Urothelial Cancer (LG-UTUC)[34] - Its reverse thermal gel technology becomes a semi-solid at body temperature, allowing the drug to remain in the collecting system for four to six hours for sustained chemoablative therapy[33] - Serious side effects can include swelling and narrowing of the ureter (ureteric obstruction) and bone marrow problems leading to decreased blood cell counts[44] About UroGen Pharma Ltd. UroGen is a biotech company focused on developing and commercializing innovative solutions for urothelial and specialty cancers using its proprietary RTGel® platform, with two approved products - UroGen is a biotech company dedicated to developing and commercializing innovative solutions for urothelial and specialty cancers[42] - The company's proprietary RTGel® platform is a sustained-release, hydrogel-based technology designed to improve the therapeutic profiles of existing drugs for local therapy[42] Other Information This section provides details on the conference call for Q2 results and includes cautionary forward-looking statements regarding potential risks and uncertainties Conference Call & Webcast Information UroGen management hosted a conference call and webcast on August 7, 2025, to discuss financial results and provide a business update - A live conference call and webcast were held on the day of the earnings release to review financial results and provide a general business update[20] Forward-Looking Statements This section contains cautionary forward-looking statements, highlighting various risks and uncertainties that could cause actual results to differ materially from projections - The press release includes forward-looking statements regarding the market opportunity for ZUSDURI, pipeline progress, financial guidance, and the potential of its RTGel technology[43] - These statements are subject to numerous risks and uncertainties, including clinical results, regulatory approval, commercialization challenges, competition, and market acceptance[43]