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AEON Biopharma(AEON) - 2024 Q3 - Quarterly Results
AEONAEON Biopharma(AEON)2024-11-13 21:06

Financial Performance - AEON Biopharma reported total assets of 4,004,000asofSeptember30,2024,downfrom4,004,000 as of September 30, 2024, down from 6,845,000 at the end of 2023, indicating a decrease of approximately 41%[8] - Cash and cash equivalents decreased significantly to 537,000from537,000 from 5,158,000, representing a decline of about 90%[8] - Total current liabilities were reported at 10,726,000,adecreasefrom10,726,000, a decrease from 13,049,000, reflecting a reduction of approximately 18%[8] - The company has a stockholders' deficit of 32,090,000asofSeptember30,2024,comparedtoadeficitof32,090,000 as of September 30, 2024, compared to a deficit of 153,044,000 at the end of 2023, showing an improvement of about 79%[8] - AEON's accumulated deficit decreased to 433,679,000from433,679,000 from 473,602,000, indicating a reduction of approximately 8%[8] - For the three months ended September 30, 2024, total operating expenses were 4,016,000,comparedto4,016,000, compared to 283,714,000 for the same period in 2023, reflecting a significant decrease[9] - The net loss for the three months ended September 30, 2024, was 6,171,000,or6,171,000, or 0.16 per share, compared to a net loss of 297,711,000,or297,711,000, or 8.01 per share, for the same period in 2023[9] - The company reported a change in the fair value of contingent consideration amounting to 348,000forthethreemonthsendedSeptember30,2024,comparedtoalossof348,000 for the three months ended September 30, 2024, compared to a loss of 75,939,000 in 2023[9] - Total operating costs and expenses for the nine months ended September 30, 2024, were 283,714,000,comparedto283,714,000, compared to 29,644,000 for the same period in 2023[9] - The company experienced a loss from operations of 4,016,000forthethreemonthsendedSeptember30,2024,comparedtoalossof4,016,000 for the three months ended September 30, 2024, compared to a loss of 283,714,000 in 2023[9] - The change in fair value of convertible notes resulted in a loss of 1,878,000forthethreemonthsendedSeptember30,2024[9]RegulatoryandDevelopmentPlans−AEONplanstoinitiateprimarycomparativeanalyticalstudiesforABP−450inQ42024,contingentonsecuringcapitalresources[2]−ThecompanyaimstoholdaBiosimilarBiologicalProductDevelopmentType2meetingwiththeFDAin2025todiscussoutcomesfromtheplannedstudies[4]−AEONisalignedwiththeFDAontheinitialkeyrequirementsforthe351(k)regulatorypathwayforABP−450,whichutilizesBOTOXasthereferenceproduct[3]−ThecompanyisevaluatingallavailableoptionstosecurecapitalresourcesnecessaryforexecutingitsregulatorystrategyforABP−450[2]MergerImpact−AEONcompletedamergerwithAEONBiopharmaSub,Inc.onJuly21,2023,whichhasimpactedthecomparabilityoffinancialresultsbetweenperiods[11]−Thecompany’sfinancialstatementsreflectthehistoricaloperatingresultsofAEONBiopharmaSub,Inc.priortothemergerandthecombinedresultsfollowingthemerger[11]DevelopmentRights−ThecompanyhasexclusivedevelopmentanddistributionrightsforABP−450intheU.S.,Canada,theEU,theUK,andotherterritories[6]ResearchandDevelopment−ResearchanddevelopmentexpensesfortheninemonthsendedSeptember30,2024,were1,878,000 for the three months ended September 30, 2024[9] Regulatory and Development Plans - AEON plans to initiate primary comparative analytical studies for ABP-450 in Q4 2024, contingent on securing capital resources[2] - The company aims to hold a Biosimilar Biological Product Development Type 2 meeting with the FDA in 2025 to discuss outcomes from the planned studies[4] - AEON is aligned with the FDA on the initial key requirements for the 351(k) regulatory pathway for ABP-450, which utilizes BOTOX as the reference product[3] - The company is evaluating all available options to secure capital resources necessary for executing its regulatory strategy for ABP-450[2] Merger Impact - AEON completed a merger with AEON Biopharma Sub, Inc. on July 21, 2023, which has impacted the comparability of financial results between periods[11] - The company’s financial statements reflect the historical operating results of AEON Biopharma Sub, Inc. prior to the merger and the combined results following the merger[11] Development Rights - The company has exclusive development and distribution rights for ABP-450 in the U.S., Canada, the EU, the UK, and other territories[6] Research and Development - Research and development expenses for the nine months ended September 30, 2024, were 11,144,000, down from $19,803,000 in 2023, indicating a reduction in R&D spending[9] - The weighted average shares of common stock outstanding for the three months ended September 30, 2024, were 39,515,292, compared to 37,159,600 for the same period in 2023[10]