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Vivos Therapeutics(VVOS) - 2024 Q4 - Annual Report

Financial Performance - Total revenue for 2024 was 15,031,000,representinga8.915,031,000, representing a 8.9% increase from 13,801,000 in 2023[432]. - Product revenue increased to 7,874,000in2024,up25.67,874,000 in 2024, up 25.6% from 6,270,000 in 2023[432]. - Service revenue decreased to 7,157,000in2024,down57,157,000 in 2024, down 5% from 7,531,000 in 2023[432]. - Gross profit for 2024 was 9,019,000,comparedto9,019,000, compared to 8,271,000 in 2023, reflecting a gross margin improvement[432]. - Operating loss narrowed to 11,171,000in2024from11,171,000 in 2024 from 17,296,000 in 2023[432]. - Net loss for 2024 was 11,136,000,animprovementfromanetlossof11,136,000, an improvement from a net loss of 13,583,000 in 2023[432]. - The basic and diluted net loss per share for 2024 was 2.22,comparedto2.22, compared to 11.14 in 2023, showing a substantial improvement[564]. Cash and Assets - Cash and cash equivalents increased to 6,260,000attheendof2024,upfrom6,260,000 at the end of 2024, up from 1,643,000 at the end of 2023[438]. - Total assets grew to 15,284,000in2024,comparedto15,284,000 in 2024, compared to 10,730,000 in 2023, indicating a significant increase in the company's asset base[430]. - Total stockholders' equity rose to 7,954,000in2024from7,954,000 in 2024 from 411,000 in 2023, reflecting improved financial health[430]. - As of December 31, 2024, the company had approximately 6.3millionincashandcashequivalents,whichisinsufficienttofundoperationsoverthenexttwelvemonths[499].RevenueSourcesandBusinessModelAsubstantialportionoffuturerevenueisexpectedtoderivefromsalesofappliancesandtreatmentsthroughanewstrategicallianceandacquisitionmodel[17].ThecompanyexpectstoderiveasignificantportionoffuturerevenuefromsalesthroughDentalServiceOrganizations(DSOs)andMedicalServiceOrganizations(MSOs)[17].ThecompanyispivotingitsbusinessstrategytofocusoncontractualallianceswithOSAhealthcareproviders,movingawayfromdependenceondentistsales[448].RevenuefromMyoCorrectservicesisrecognizedovera12monthperformanceperiodastherapysessionsoccur[462].RevenuefromappliancesalesisrecognizedwhencontrolistransferredtotheVIP,withproductrevenuerecordeduponshipmenttotheVIP[468].RegulatoryandOperationalRisksThecompanyfacesrisksrelatedtogovernmentregulationsandtheneedtoobtainregulatoryapprovalsforitsproducts[20].ThecompanyissubjecttoextensivegovernmentalregulationthatcouldpreventitfrommanufacturingorobtainingVivosappliancesorintroducingnewproducts[20].Thecompanyhasidentifiedmaterialweaknessesininternalcontrols,whichmayresultinmaterialmisstatementsofconsolidatedfinancialstatements[17].Thecompanymaynotbeabletoprotectitspatentsandproprietarytechnology,exposingittointellectualpropertyclaimsorlitigation[20].EquityandFinancingTheweightedaveragenumberofsharesoutstandingincreasedto5,019,886in2024from1,219,381in2023,indicatingsignificantequityfinancingactivity[432].Thecompanyraisedequitycapitalinlate2023andthroughout2024toaddresscashneedsandbolsterstockholdersequityforNasdaqcompliance[500].ThecompanyclosedaprivateplacementonNovember2,2023,raising6.3 million in cash and cash equivalents, which is insufficient to fund operations over the next twelve months[499]. Revenue Sources and Business Model - A substantial portion of future revenue is expected to derive from sales of appliances and treatments through a new strategic alliance and acquisition model[17]. - The company expects to derive a significant portion of future revenue from sales through Dental Service Organizations (DSOs) and Medical Service Organizations (MSOs)[17]. - The company is pivoting its business strategy to focus on contractual alliances with OSA healthcare providers, moving away from dependence on dentist sales[448]. - Revenue from MyoCorrect services is recognized over a 12-month performance period as therapy sessions occur[462]. - Revenue from appliance sales is recognized when control is transferred to the VIP, with product revenue recorded upon shipment to the VIP[468]. Regulatory and Operational Risks - The company faces risks related to government regulations and the need to obtain regulatory approvals for its products[20]. - The company is subject to extensive governmental regulation that could prevent it from manufacturing or obtaining Vivos appliances or introducing new products[20]. - The company has identified material weaknesses in internal controls, which may result in material misstatements of consolidated financial statements[17]. - The company may not be able to protect its patents and proprietary technology, exposing it to intellectual property claims or litigation[20]. Equity and Financing - The weighted average number of shares outstanding increased to 5,019,886 in 2024 from 1,219,381 in 2023, indicating significant equity financing activity[432]. - The company raised equity capital in late 2023 and throughout 2024 to address cash needs and bolster stockholders' equity for Nasdaq compliance[500]. - The company closed a private placement on November 2, 2023, raising 4.0 million by selling 130,000 shares and warrants, with issuance costs of approximately 0.5million[518].TheDecember2024Offeringraisedapproximately0.5 million[518]. - The December 2024 Offering raised approximately 3.5 million, with offering expenses of about 0.5million[535].CustomerandSupplierDynamicsThecompanyreliesonfivesuppliersforapproximately570.5 million[535]. Customer and Supplier Dynamics - The company relies on five suppliers for approximately 57% of total purchases, indicating a significant supplier concentration risk[571]. - No single customer accounted for more than 10% of sales or accounts receivable, demonstrating a diversified customer base[570]. Research and Development - Research and development costs incurred were approximately 0.1 million for both years ended December 31, 2024 and 2023[485]. Employee and Compensation - The company entered into an employment agreement with Dr. Scott Simonetti for an annual salary of approximately 0.1millionandafiveyearwarrantfor16,000sharesatanexercisepriceof0.1 million and a five-year warrant for 16,000 shares at an exercise price of 15.25, contingent on achieving specific FDA milestones[516]. - For the year ended December 31, 2024, share-based compensation expense was approximately 0.8million,downfrom0.8 million, down from 1.1 million in 2023[544].