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Vivos Therapeutics(VVOS) - 2024 Q3 - Quarterly Report

Financial Performance - Total revenue for September 2024 was 3,860,000,anincreaseof16.93,860,000, an increase of 16.9% compared to 3,301,000 in September 2023[12] - Product revenue reached 1,958,000inSeptember2024,up33.51,958,000 in September 2024, up 33.5% from 1,466,000 in the same period last year[12] - Service revenue was 1,902,000forSeptember2024,slightlyupfrom1,902,000 for September 2024, slightly up from 1,835,000 in September 2023[12] - Gross profit for the quarter was 2,334,000,representingagrossmarginof60.52,334,000, representing a gross margin of 60.5%, compared to 1,747,000 and a margin of 52.9% in the prior year[12] - Operating loss narrowed to 2,645,000inSeptember2024from2,645,000 in September 2024 from 3,640,000 in September 2023[12] - Net loss for the quarter was 2,616,000,comparedtoanetlossof2,616,000, compared to a net loss of 2,093,000 in the same quarter last year[12] - Total revenue for the nine months ended September 30, 2024, was 11.333million,anincreasefrom11.333 million, an increase from 10.553 million for the same period in 2023, representing a growth of approximately 7.4%[85] - Product revenue for the three months ended September 30, 2024, was 1.958million,upfrom1.958 million, up from 1.466 million in the same period of 2023, reflecting a growth of approximately 33.5%[85] - Service revenue for the three months ended September 30, 2024, was 1.902million,comparedto1.902 million, compared to 1.835 million for the same period in 2023, indicating a slight increase of approximately 3.7%[85] Cash and Assets - Cash and cash equivalents increased significantly to 6,311,000asofSeptember30,2024,from6,311,000 as of September 30, 2024, from 1,643,000 at the end of 2023[10] - Total assets grew to 15,347,000asofSeptember30,2024,comparedto15,347,000 as of September 30, 2024, compared to 10,730,000 at the end of 2023[11] - Total liabilities decreased to 7,682,000from7,682,000 from 10,319,000 at the end of 2023, indicating improved financial health[11] - Stockholders' equity increased to 7,665,000asofSeptember30,2024,upfrom7,665,000 as of September 30, 2024, up from 411,000 at the end of 2023[11] Losses and Expenses - Net loss for the nine months ended September 30, 2024, was 8,309,000,comparedtoanetlossof8,309,000, compared to a net loss of 9,324,000 for the same period in 2023, representing a 10.9% improvement[15] - The company reported a net cash used in operating activities of 9,751,000fortheninemonthsendedSeptember30,2024,comparedto9,751,000 for the nine months ended September 30, 2024, compared to 9,198,000 for the same period in 2023[15] - The company recognized approximately 0.7millionand0.7 million and 1.0 million of share-based compensation expense for the nine months ended September 30, 2024 and 2023, respectively[116] Revenue Recognition and Accounting - The Company utilizes a five-step model for revenue recognition, ensuring compliance with ASC Topic 606[32] - Revenue from appliance sales is recognized when control is transferred to the VIP, reflecting the expected consideration for those products[45] - The Company recognizes service revenue related to VIP enrollments when the underlying services are performed, with unearned revenue recorded as a contract liability[34] - Contract liabilities decreased from 2.613millionasofSeptember30,2023,to2.613 million as of September 30, 2023, to 1.491 million as of September 30, 2024, representing a decline of approximately 43%[87] - Revenue recognized from contract liabilities for the nine months ended September 30, 2024, was 1.5million,comparedto1.5 million, compared to 1.4 million for the same period in 2023, indicating a slight increase of about 7%[87] Strategic Initiatives - The Company entered a strategic marketing and distribution alliance in June 2024 to enhance revenue generation by offering comprehensive solutions to OSA patients[24] - A strategic pivot announced in June 2024 aims to drive revenue through contractual alliances with dentists and healthcare providers, moving away from solely relying on enrollments in the VIP program[153] - The company secured a 7.5millionequitygrowthinvestmentfromVCOInvestorsLLC,whichhasstrengtheneditscashpositionandfacilitatedthelaunchofnewstrategicalliances[155]MarketandOperationalChallengesThecompanycontinuestomonitortheimpactofCOVID19andinflationonitsbusiness,withongoinguncertaintiesaffectingnewenrollmentsinthedentalmarket[130][131]Thecompanyhasadjusteditsstandardpricingforapplianceproductsduetoinflationarypressures,effectiveMay1,2022,andmayneedtodosoagainin2024[131]Thecompanyexperiencedadeclineinproductsalesrevenueinlate2023,butthistrendbegantoreverseinQ22024,withapproximately327.5 million equity growth investment from V-CO Investors LLC, which has strengthened its cash position and facilitated the launch of new strategic alliances[155] Market and Operational Challenges - The company continues to monitor the impact of COVID-19 and inflation on its business, with ongoing uncertainties affecting new enrollments in the dental market[130][131] - The company has adjusted its standard pricing for appliance products due to inflationary pressures, effective May 1, 2022, and may need to do so again in 2024[131] - The company experienced a decline in product sales revenue in late 2023, but this trend began to reverse in Q2 2024, with approximately 32% of VIPs initiating new treatment cases as of September 30, 2024[172] Financing Activities - Proceeds from the issuance of common stock amounted to 4,296,000 during the nine months ended September 30, 2024[15] - The company raised approximately 7.4millionfromaprivateplacementinJanuary2023and7.4 million from a private placement in January 2023 and 4.0 million from another private placement in November 2023[95][99] - The Company intends to use net proceeds from the Private Placement and Offering for general working capital and corporate purposes[102][108] Clinical and Product Development - The Company offers three clinical pathways for treating obstructive sleep apnea (OSA) and related conditions, including Guided Growth and Development, Lifeline, and Complete Airway Repositioning and Expansion (CARE)[20] - The CARE program features patented appliances that have shown to reverse OSA symptoms in up to 80% of patients in a small study subset[21] - The company is conducting a clinical trial with Stanford University to evaluate the efficacy of its FDA-cleared DNA appliance compared to CPAP for treating sleep apnea, enrolling 150 patients[175]