UroGen Pharma(URGN) - 2025 Q2 - Quarterly Report

PART I. FINANCIAL INFORMATION Financial Statements (Unaudited) Unaudited financial statements for June 30, 2025, show increased revenue, a wider net loss, decreased cash, and a growing shareholders' deficit, with ongoing losses anticipated Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Assets | | | | Cash and cash equivalents | $92,904 | $171,987 | | Total current assets | $196,868 | $276,135 | | Total Assets | $208,717 | $285,711 | | Liabilities & Shareholders' Deficit | | | | Total current liabilities | $47,548 | $45,949 | | Total Liabilities | $302,093 | $294,514 | | Total Shareholders' Deficit | ($93,376) | ($8,803) | Condensed Consolidated Statements of Operations Highlights (in thousands) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | Revenue | $24,215 | $21,848 | $44,469 | $40,629 | | Gross profit | $20,665 | $19,619 | $38,589 | $36,672 | | 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) | Condensed Consolidated Statements of Cash Flow Highlights (Six Months Ended June 30, in thousands) | Cash Flow Activity | 2025 | 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | ($81,849) | ($55,483) | | Net cash provided by investing activities | $2,443 | $25,516 | | Net cash provided by financing activities | $330 | $154,942 | | Increase (Decrease) in Cash | ($79,076) | $124,975 | - The company has a history of net losses, with an accumulated deficit of $900.0 million as of June 30, 2025. Management expects losses to continue due to the commercial launch of Zusduri and ongoing R&D activities[29] - Management believes that its cash, cash equivalents, and marketable securities as of June 30, 2025, are sufficient to fund operations for more than one year from the financial statement issuance date[31] Management's Discussion and Analysis of Financial Condition and Results of Operations Management discusses financial condition and operations, highlighting Zusduri's FDA approval and commercial launch, increased Jelmyto revenue, rising operating expenses, and sufficient liquidity for the next year Overview and Key Developments UroGen, a biotechnology company, achieved FDA approval for Zusduri on June 12, 2025, for NMIBC, and is commercially launching it while advancing its pipeline candidates - The FDA approved the New Drug Application (NDA) for Zusduri on June 12, 2025, for the treatment of adults with recurrent low-grade intermediate risk NMIBC[146][158] - The company estimates the annual treatable population for Zusduri's indication in the U.S. is approximately 82,000 patients, representing a potential market opportunity of over $5.0 billion[146] - The company's immuno-uro-oncology pipeline includes UGN-301 (anti-CTLA-4 antibody) and UGN-501 (oncolytic virus), with a Phase 1 study of UGN-501 planned for 2026[145][178] Results of Operations Jelmyto revenues increased for the three and six months ended June 30, 2025, but net loss widened significantly due to higher operating, selling, marketing, and R&D expenses Comparison of Results for the Three Months Ended June 30 (in thousands) | Item | 2025 | 2024 | Change | Reason for Change | | :--- | :--- | :--- | :--- | :--- | | Revenue | $24,215 | $21,848 | $2,367 | Increased volume and price of Jelmyto sales | | R&D Expenses | $18,914 | $15,402 | $3,512 | Higher manufacturing costs for Zusduri and UGN-103 trial costs | | Selling & Marketing | $27,859 | $18,872 | $8,987 | Zusduri commercial preparation and sales force expansion | | Operating Loss | ($41,448) | ($25,839) | ($15,609) | Increased operating expenses outpaced revenue growth | | Net Loss | ($49,940) | ($33,403) | ($16,537) | Higher operating loss | Comparison of Results for the Six Months Ended June 30 (in thousands) | Item | 2025 | 2024 | Change | Reason for Change | | :--- | :--- | :--- | :--- | :--- | | Revenue | $44,469 | $40,629 | $3,840 | Increased volume of Jelmyto sales | | R&D Expenses | $38,785 | $30,896 | $7,889 | Higher manufacturing costs for Zusduri, UGN-103 trial, and IconOVir asset acquisition | | Selling & Marketing | $49,981 | $35,972 | $14,009 | Zusduri commercial preparation activities | | Operating Loss | ($78,362) | ($51,579) | ($26,783) | Increased operating expenses outpaced revenue growth | | Net Loss | ($93,783) | ($65,689) | ($28,094) | Higher operating loss | Liquidity and Capital Resources As of June 30, 2025, the company held $161.6 million in cash and equivalents, funded operations through equity and debt, and believes current liquidity is sufficient for over one year - The company held $161.6 million in cash, cash equivalents, and marketable securities as of June 30, 2025[223] - The company has a loan agreement with Pharmakon, with an additional $75.0 million fourth tranche available upon Zusduri's FDA approval, which the company does not intend to draw down[230][231] - Management believes existing cash is sufficient to fund operations beyond one year from the report's issuance date[236] Quantitative and Qualitative Disclosures About Market Risk The company faces market risks from interest rate fluctuations on its investment portfolio and foreign currency exchange rates, particularly for NIS-denominated operating expenses, without current hedging - The company's primary market risks are interest rate fluctuations on its $161.6 million in cash and marketable securities and foreign currency exchange risk[256] - A significant portion of operating expenses are incurred in New Israeli Shekels (NIS), creating exposure to currency fluctuations against the U.S. dollar; a 10% change in the NIS-to-Dollar exchange rate would not have had a material effect on operating expenses for the six months ended June 30, 2025[258] Controls and Procedures Management concluded that disclosure controls and procedures were effective as of June 30, 2025, with no material changes to internal control over financial reporting during the quarter - Based on an evaluation as of June 30, 2025, the principal executive officer and principal financial officer concluded that the company's disclosure controls and procedures were effective[261] - No changes in internal control over financial reporting occurred during the quarter ended June 30, 2025, that have materially affected, or are reasonably likely to materially affect, internal controls[262] PART II. OTHER INFORMATION Legal Proceedings UroGen is engaged in patent infringement litigation against Teva Pharmaceuticals, seeking to prevent the market entry of Teva's generic Jelmyto before patent expiration, with a trial set for October 2026 - The company filed a lawsuit against Teva Pharmaceuticals on April 2, 2024, for patent infringement related to Teva's application to market a generic version of Jelmyto[264] - The lawsuit alleges infringement of U.S. Patent Numbers 9,040,074, 9,950,069, and 12,268,745, and seeks to prevent market entry of Teva's generic product; a bench trial is scheduled for October 2026[264] Risk Factors The company faces material risks including historical losses, financing needs, dependence on product commercialization, clinical development challenges, competition, supply chain reliance, intellectual property protection, and geopolitical instability - The company has a history of significant losses ($900.0 million accumulated deficit as of June 30, 2025) and may require additional financing, which may not be available on acceptable terms[266][270] - The business is highly dependent on the successful commercialization of its two approved products, Jelmyto and Zusduri, and faces risks related to market adoption, competition, and reimbursement[266][296] - The company relies on third-party, single-source suppliers for key components of its products, creating risks of supply chain disruption that could impair development and commercialization[267][361] - Significant operations in Israel expose the company to risks from political, economic, and military instability in the region[267][553] Unregistered Sales of Equity Securities and Use of Proceeds There were no unregistered sales of equity securities during the period - The company reported no unregistered sales of equity securities[581] Defaults Upon Senior Securities There were no defaults upon senior securities during the period - The company reported no defaults upon senior securities[582] Mine Safety Disclosures This item is not applicable to the company - Not applicable[582] Other Information There was no other information to report during the period - The company reported no other information[583] Exhibits This section lists exhibits filed with the Form 10-Q, including corporate documents and Sarbanes-Oxley certifications from the CEO and CFO - Exhibits filed include CEO and CFO certifications pursuant to Sarbanes-Oxley Sections 302 and 906, and the company's 2019 Inducement Plan[584]