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UroGen Pharma(URGN) - 2024 Q3 - Quarterly Report
URGNUroGen Pharma(URGN)2024-11-06 13:04
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Market Potential - UGN-102, if approved, could address a treatable population of approximately 82,000 low-grade intermediate risk NMIBC patients, with a total addressable market exceeding 5.0billion[142].−Approximately685.0 billion[142]. - Approximately 68% of low-grade intermediate risk NMIBC patients experience two or more recurrences, highlighting the need for effective non-surgical treatments[143]. Product Performance - Jelmyto achieved a complete response rate of 58% in the Phase 3 OLYMPUS trial, with a durability of response estimated at 81.8% at 12 months[150][151]. - The median duration of response for patients in a follow-up study of Jelmyto was reported at 28.9 months, with 75% of patients showing no disease recurrence at the four-year data cutoff[154][156]. - In the Phase 2b OPTIMA II trial, 65.1% (41 out of 63) of patients treated with UGN-102 achieved a complete response (CR) three months after therapy initiation[162]. - The Phase 3 ENVISION trial demonstrated a CR rate of 79.6% at three months for patients treated with UGN-102[165]. - The ATLAS trial showed a 64.8% CR rate at three months for patients receiving only UGN-102, compared to 63.6% for TURBT alone[165]. - The median duration of response (DOR) for UGN-102 in a follow-up study was reported as 24.4 months for patients who achieved CR[163]. - The ENVISION trial reported that 60.8% of all enrolled patients were in CR at 12 months[169]. - UGN-102 was found suitable for at-home administration, with 75% of patients achieving CR three months after treatment[167]. Regulatory Approvals - The FDA approved Jelmyto on April 15, 2020, for the treatment of low-grade UTUC, with Orphan Drug exclusivity extending until April 15, 2027[148]. - The FDA accepted the NDA for UGN-102 with a PDUFA goal date of June 13, 2025, potentially making it the first FDA-approved treatment for low-grade intermediate-risk NMIBC[170]. Financial Performance - Revenue for the three months ended September 30, 2024, was 25.2 million, an increase of 4.3millionfrom4.3 million from 20.9 million in the same period of 2023, primarily due to increased sales volume of Jelmyto[200]. - Revenue for the nine months ended September 30, 2024, was 65.8million,up65.8 million, up 6.6 million from 59.2millionin2023,attributedtoincreasedsalesvolumeofJelmyto[210].−ThenetlossforthethreemonthsendedSeptember30,2024,was59.2 million in 2023, attributed to increased sales volume of Jelmyto[210]. - The net loss for the three months ended September 30, 2024, was 23.7 million, compared to a net loss of 21.9millioninthesameperiodof2023[199].−TheoperatinglossfortheninemonthsendedSeptember30,2024,was21.9 million in the same period of 2023[199]. - The operating loss for the nine months ended September 30, 2024, was 69.1 million, an increase of 18.2millionfrom18.2 million from 50.9 million in 2023[209]. Expenses - Research and development expenses for the three months ended September 30, 2024, were 11.4million,up11.4 million, up 1.2 million from 10.2millionin2023,mainlyduetocostsassociatedwiththePhase3UTOPIAtrialforUGN−103[202].−Sellingandmarketingexpensesincreasedto10.2 million in 2023, mainly due to costs associated with the Phase 3 UTOPIA trial for UGN-103[202]. - Selling and marketing expenses increased to 17.8 million for the three months ended September 30, 2024, from 12.6millionin2023,reflectinghigherUGN−102brandmarketingcostsandexpansionofthesalesforce[203].−Generalandadministrativeexpensesroseto12.6 million in 2023, reflecting higher UGN-102 brand marketing costs and expansion of the sales force[203]. - General and administrative expenses rose to 11.2 million for the three months ended September 30, 2024, compared to 9.2millionin2023,drivenbyhighercompensationandpre−commercializationreadinesssupportforUGN−102[204].−Researchanddevelopmentexpensesincreasedby9.2 million in 2023, driven by higher compensation and pre-commercialization readiness support for UGN-102[204]. - Research and development expenses increased by 8.0 million to 42.3millionfortheninemonthsendedSeptember30,2024,comparedto42.3 million for the nine months ended September 30, 2024, compared to 34.3 million in 2023, primarily due to higher manufacturing costs and regulatory expenses[212]. - Selling and marketing expenses rose by 13.1millionto13.1 million to 53.8 million for the nine months ended September 30, 2024, compared to 40.7millionin2023,mainlydrivenbyUGN−102brandmarketingcosts[213].−Generalandadministrativeexpensesincreasedby40.7 million in 2023, mainly driven by UGN-102 brand marketing costs[213]. - General and administrative expenses increased by 4.4 million to 32.5millionfortheninemonthsendedSeptember30,2024,comparedto32.5 million for the nine months ended September 30, 2024, compared to 28.1 million in 2023, primarily due to higher compensation and communication expenses related to UGN-102[214]. Cash Flow and Liquidity - As of September 30, 2024, the company had 254.2millionincashandcashequivalentsandmarketablesecurities,indicatingastrongliquidityposition[217].−Netcashusedinoperatingactivitieswas254.2 million in cash and cash equivalents and marketable securities, indicating a strong liquidity position[217]. - Net cash used in operating activities was 83.1 million for the nine months ended September 30, 2024, compared to 63.4millionforthesameperiodin2023,reflectinga63.4 million for the same period in 2023, reflecting a 19.7 million increase due to higher operating expenses[246]. - Net cash used in investing activities was 81.2millionfortheninemonthsendedSeptember30,2024,adecreaseof81.2 million for the nine months ended September 30, 2024, a decrease of 91.6 million compared to net cash provided of 10.4millioninthesameperiodof2023,primarilyduetoincreasedinvestmentsinmarketablesecurities[247].−Netcashprovidedbyfinancingactivitieswas10.4 million in the same period of 2023, primarily due to increased investments in marketable securities[247]. - Net cash provided by financing activities was 194.5 million for the nine months ended September 30, 2024, an increase of 77.6millionfrom77.6 million from 116.9 million in the same period of 2023, mainly due to proceeds from share issuance and debt related to the Pharmakon loan[248]. Future Outlook - The company expects research and development expenses to increase over the next several years as clinical programs progress and additional product candidates are developed[185]. - The company may need to raise additional capital in the future to fund operations and product development, with no assurances that sufficient financing will be secured[228]. Legal and Regulatory Matters - The company is currently involved in a lawsuit against Teva Pharmaceuticals for patent infringement, seeking to prevent market entry of a generic product prior to patent expiry[259]. - The company reported no material changes in internal control over financial reporting during the quarter ended September 30, 2024[257]. Miscellaneous - Inflation has not materially affected the company's business or financial condition during the nine months ended September 30, 2024[251]. - The company does not currently engage in currency hedging activities but may consider it in the future to manage foreign currency exposure[253]. - A 10% change in interest rates or NIS-to-Dollar exchange rates would not have had a material effect on the company's cash and cash equivalents or operating expenses as of September 30, 2024[249][252].