UroGen Pharma(URGN) - 2025 Q1 - Quarterly Results

Business and Financial Highlights UroGen is approaching a pivotal period with the anticipated FDA approval of its lead product, UGN-102, in June 2025, targeting a potential $5 billion market for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer - The company is entering a pivotal period with the anticipated FDA approval of its lead pipeline product, UGN-102, in June 2025, representing a significant commercial opportunity with a total addressable market of over $5 billion[3] Q1 2025 Key Highlights | Metric | Value | Note | | :--- | :--- | :--- | | UGN-102 PDUFA Date | June 13, 2025 | FDA target action date | | JELMYTO® Net Sales | $20.3 million | Q1 2025 | | JELMYTO® Underlying Demand Growth | 12% | Year-over-year | | Cash and Equivalents | $200.4 million | As of March 31, 2025 | Pipeline and Product Updates UroGen provided significant updates across its portfolio, with UGN-102 on track for its PDUFA date, JELMYTO showing steady demand growth, and the early-stage pipeline expanding with UGN-501 and UGN-301 advancements UGN-102 (mitomycin) for intravesical solution The New Drug Application (NDA) for UGN-102 is under FDA review with a PDUFA target date of June 13, 2025, supported by positive 18-month data from the Phase 3 ENVISION trial - The FDA has set a PDUFA target action date of June 13, 2025, for UGN-102 and scheduled an ODAC meeting for May 21, 2025[7] - Updated 18-month data from the ENVISION trial showed the probability of remaining in complete response was 80.6%, consistent with prior 12-month estimates[7] - Patient-reported outcomes from three studies (OPTIMA II, ATLAS, ENVISION) showed that UGN-102 did not have a negative impact on symptom burden, patient function, or quality of life[7] JELMYTO (mitomycin) for pyelocalyceal solution JELMYTO generated $20.3 million in net product revenue in Q1 2025, an 8% increase over Q1 2024, driven by 12% underlying demand growth, with long-term data showing a median duration of response of 47.8 months JELMYTO Q1 Performance | Metric | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Net Product Revenue | $20.3M | $18.8M | - Year-over-year revenue growth of 8% was driven by underlying demand growth of 12%, partially offset by higher 340B chargebacks[11] - Long-term follow-up from the JELMYTO Phase 3 study showed a median Duration of Response (DOR) of 47.8 months for all patients achieving complete response[18] Other Pipeline Developments UroGen is actively advancing its broader pipeline, with enrollment complete for the Phase 1 study of UGN-301, the acquisition of UGN-501, and expected completion of UGN-103 Phase 3 enrollment by mid-2025 - Enrollment is complete in the Phase 1 study of UGN-301 (zalifrelimab) in high-grade NMIBC, with the investigational treatment demonstrating an acceptable safety profile[8] - In February 2025, UroGen acquired UGN-501 (ICVB-1042), a next-generation oncolytic virus, from IconOVir Bio to expand its nonclinical oncology portfolio[9] - Enrollment in the Phase 3 UTOPIA trial of UGN-103 is expected to be completed by mid-2025, and a Phase 3 trial for UGN-104 is planned to initiate by mid-2025[19] Q1 2025 Financial Performance UroGen reported a net loss of $43.84 million for Q1 2025, compared to a $32.29 million loss in Q1 2024, primarily due to higher operating expenses for UGN-102 commercial preparations and R&D increases, ending the quarter with $200.41 million in cash and marketable securities Key Financial Metrics In Q1 2025, UroGen's revenue grew to $20.25 million from $18.78 million year-over-year, but increased operating expenses led to a higher net loss of $43.84 million, or ($0.92) per share Condensed Consolidated Statements of Operations (in millions USD, except per share data) | Metric | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Revenue | $20.25M | $18.78M | | Gross Profit | $17.92M | $17.05M | | R&D Expenses | $19.87M | $15.49M | | SG&A Expenses | $34.97M | $27.30M | | Operating Loss | $(36.91)M | $(25.74)M | | Net Loss | $(43.84)M | $(32.29)M | | Net Loss per Share | $(0.92) | $(0.87) | - The $4.4 million increase in R&D expenses was primarily driven by the acquisition of UGN-501, higher manufacturing costs, and costs for the Phase 3 UTOPIA trial[12] - The $7.7 million increase in SG&A expenses was primarily driven by UGN-102 commercial preparation activities[13] Financial Position As of March 31, 2025, UroGen held $200.41 million in cash, cash equivalents, and marketable securities, a decrease from $241.71 million at the end of 2024, resulting in a total shareholders' deficit of $46.46 million Selected Consolidated Balance Sheet Data (in millions USD) | Metric | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash, cash equivalents and marketable securities | $200.41M | $241.71M | | Total assets | $247.62M | $285.71M | | Total liabilities | $294.08M | $294.51M | | Total shareholders' deficit | $(46.46)M | $(8.80)M | 2025 Financial Guidance UroGen reaffirmed its full-year 2025 financial guidance, expecting JELMYTO net product revenues between $94 million and $98 million, and total operating expenses between $215 million and $225 million - Guidance for full-year 2025 net product revenues for JELMYTO remains unchanged at $94 million to $98 million[21] - Full-year 2025 operating expenses are expected to be in the range of $215 million to $225 million, including $11 million to $14 million in non-cash share-based compensation[21] Product and Disease Information This section provides background on UroGen's approved product JELMYTO, its lead investigational candidate UGN-102, and the disease they target, Upper Tract Urothelial Cancer (UTUC), all based on the proprietary RTGel® technology About JELMYTO JELMYTO (mitomycin) is a prescription medicine for adult patients with low-grade Upper Tract Urothelial Cancer (LG-UTUC), utilizing a reverse thermal gel for prolonged chemoablative therapy, with key safety warnings including ureteric obstruction and bone marrow problems - JELMYTO is a mitomycin-containing reverse thermal gel indicated for the treatment of adult patients with LG-UTUC[28] - Important safety information includes a contraindication for patients with a hole or tear (perforation) of the bladder or upper urinary tract[30] - Serious side effects may include swelling and narrowing of the ureter (ureteric obstruction) and bone marrow problems causing a decrease in blood cell counts[36] About UGN-102 UGN-102 is an investigational formulation of mitomycin using UroGen's proprietary RTGel® technology, in Phase 3 development for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC), with an FDA PDUFA goal date of June 13, 2025 - UGN-102 is an innovative drug formulation of mitomycin in Phase 3 development for recurrent LG-IR-NMIBC, utilizing UroGen's proprietary RTGel® technology[35] - The FDA accepted the NDA for UGN-102 and assigned a PDUFA goal date of June 13, 2025[37] About Upper Tract Urothelial Cancer (UTUC) Upper Tract Urothelial Cancer (UTUC) accounts for 5-10% of all urothelial cancers, with an estimated 6,000-7,000 new or recurrent low-grade cases annually in the U.S., predominantly affecting patients over 70 years old - UTUC accounts for five to ten percent of primary urothelial cancers, with approximately 6,000 - 7,000 new or recurrent LG-UTUC patients annually in the U.S[34] Forward-Looking Statements This section provides a standard legal disclaimer regarding forward-looking statements, cautioning that actual results could differ materially from expectations due to numerous risks and uncertainties, including regulatory approvals, clinical trial success, and commercialization challenges - The press release contains forward-looking statements regarding the UGN-102 regulatory timeline, market opportunities, clinical trial progress, and financial guidance[39] - These statements are subject to significant risks, including uncertain outcomes of the ODAC meeting and FDA review, potential clinical trial delays, commercialization complications, and competition[39]