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UroGen Pharma (URGN.US)2Q24 Recap: Jelmyto sales flat; operating expenses edge higher ahead of NDA completion

Investment Rating - The report maintains a Neutral rating on UroGen Pharma (URGN) with a 12-month price target of 22,indicatingapotentialupsideof51.622, indicating a potential upside of 51.6% from the current price of 14.51 [42][43]. Core Insights - UroGen Pharma's Jelmyto sales remained flat year-over-year at 21.8million,slightlybelowestimates,withchallengesrelatedtoMedicaid/MedicarediscountingimpactingrevenueguidanceforFY24[2][42].ThecompanyisfocusedoncompletingtherollingNDAsubmissionforUGN102,withexpectationsforpriorityreviewandpotentialcommercializationinearly2025[2][42].ManagementexpressedconfidenceinthecompanyscapitalizationtoreachprofitabilityasitlaunchesUGN102andadvancesitspipeline,despitecautionregardingUGN102sabilitytoreplaceTURBTsurgeryinthenearterm[2][42].FinancialSummaryUroGenPharmareportedtotaloperatingexpensesof21.8 million, slightly below estimates, with challenges related to Medicaid/Medicare discounting impacting revenue guidance for FY24 [2][42]. - The company is focused on completing the rolling NDA submission for UGN-102, with expectations for priority review and potential commercialization in early 2025 [2][42]. - Management expressed confidence in the company's capitalization to reach profitability as it launches UGN-102 and advances its pipeline, despite caution regarding UGN-102's ability to replace TURBT surgery in the near term [2][42]. Financial Summary - UroGen Pharma reported total operating expenses of 184.9 million for 2Q24, slightly above expectations, driven by pre-commercial manufacturing costs for UGN-102 and increased R&D expenses for UGN-103 [2][42]. - The gross margin improved to 90.1%, while R&D expenses increased by 7.1% year-over-year [15][42]. - The company anticipates revenue growth, with projections of 95millionto95 million to 102 million for FY24, contingent on the uptake of Jelmyto and the successful launch of UGN-102 [2][42]. Model Adjustments - The report updates its model to reflect actuals from 2Q24 and adjusts near-term operating expense assumptions based on recent trends [2][42].