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Biofrontera(BFRI) - 2023 Q1 - Quarterly Report

Financial Performance - Product revenues for Q1 2023 were 8.7million,adecreaseof8.7 million, a decrease of 1.02 million or 10.5% compared to 9.8millioninQ12022,attributedtoalackofcustomerbuyinpriortoapriceincrease[234].Thecompanyreportedanetlossof9.8 million in Q1 2022, attributed to a lack of customer buy-in prior to a price increase [234]. - The company reported a net loss of 7.478 million for Q1 2023, compared to a net income of 5.561millioninQ12022,representingachangeof5.561 million in Q1 2022, representing a change of 13.039 million [209]. - Adjusted EBITDA for Q1 2023 was (3.990)million,adecreasefrom(3.990) million, a decrease from (2.439) million in Q1 2022, with the adjusted EBITDA margin dropping from -25.0% to -45.7% [218]. - Operating expenses for Q1 2023 totaled 14.225million,anincreaseof14.225 million, an increase of 1.364 million or 10.6% from 12.861millioninQ12022[209].ForthethreemonthsendedMarch31,2023,thecompanyincurredalossfromoperationsof12.861 million in Q1 2022 [209]. - For the three months ended March 31, 2023, the company incurred a loss from operations of 5.5 million, compared to a loss of 3.1millionforthesameperiodin2022[243].Thecompanyexperiencednetcashoutflowsfromoperationsof3.1 million for the same period in 2022 [243]. - The company experienced net cash outflows from operations of 3.7 million for the three months ended March 31, 2023, compared to 2.1millionforthesameperiodin2022[243].Thecompanyreportednetcashusedinoperatingactivitiesof2.1 million for the same period in 2022 [243]. - The company reported net cash used in operating activities of 3.7 million for the three months ended March 31, 2023, compared to 2.1millionforthesameperiodin2022[249].AsofMarch31,2023,thecompanyhadanaccumulateddeficitof2.1 million for the same period in 2022 [249]. - As of March 31, 2023, the company had an accumulated deficit of 87.0 million [243]. Cash and Financing - Cash and cash equivalents as of March 31, 2023, were 13.5million,downfrom13.5 million, down from 17.2 million as of December 31, 2022 [219]. - The company anticipates needing additional equity or debt financing to support long-term growth and mitigate operational cost risks [221]. - The company is expecting to collect a receivable of 3.7millionfromBiofronteraAGforreimbursementoflegalsettlementpayments[246].CostManagementThecostofrevenuesrelatedtoproductswas3.7 million from Biofrontera AG for reimbursement of legal settlement payments [246]. Cost Management - The cost of revenues related to products was 4.547 million in Q1 2023, down 8.6% from 4.975millioninQ12022,drivenbydecreasedAmeluzproductrevenue[211].ThecompanyexpectstocontinueincurringoperatinglossesduetosignificantdiscretionarysalesandmarketingeffortsasitseekstoexpandthecommercializationofitslicensedproductsintheU.S.[244].Thecompanyanticipatesadditionalexpensestoimproveoperational,financial,andinformationsystems,aswellastosupportproductcommercializationefforts[244].MarketandOperationalOutlookThecompanyplanstoexpandsalesofAmeluzintheU.S.andaimstopositionitasthestandardofcarefortreatingactinickeratoses[199].ThecompanycontinuestomonitortheimpactoftheCOVID19pandemiconitsoperations,withoptimismforrecoveryfollowingtheendofthePublicHealthEmergencyonMay11,2023[200].FairValueAdjustmentsThefairvalueofcontingentconsiderationrelatedtotheacquisitionofCutaneaproductswasdeterminedtobe4.975 million in Q1 2022, driven by decreased Ameluz product revenue [211]. - The company expects to continue incurring operating losses due to significant discretionary sales and marketing efforts as it seeks to expand the commercialization of its licensed products in the U.S. [244]. - The company anticipates additional expenses to improve operational, financial, and information systems, as well as to support product commercialization efforts [244]. Market and Operational Outlook - The company plans to expand sales of Ameluz in the U.S. and aims to position it as the standard of care for treating actinic keratoses [199]. - The company continues to monitor the impact of the COVID-19 pandemic on its operations, with optimism for recovery following the end of the Public Health Emergency on May 11, 2023 [200]. Fair Value Adjustments - The fair value of contingent consideration related to the acquisition of Cutanea products was determined to be 6.5 million at acquisition and is re-measured at each reporting date [213]. - The change in fair value of warrant liabilities decreased by 7.7millionforthethreemonthsendedMarch31,2023,drivenbychangesintheunderlyingvalueofthecommonstock[236].Thechangeinfairvalueofinvestmentsinequitysecuritiesdecreasedby7.7 million for the three months ended March 31, 2023, driven by changes in the underlying value of the common stock [236]. - The change in fair value of investments in equity securities decreased by 2.9 million, influenced by changes in the quoted market price of Biofrontera AG's common stock [237]. Definitions - The adjusted EBITDA margin is defined as adjusted EBITDA expressed as a percentage of revenues for the period [242].