Financial Performance - Total revenue for 2024 was $15,031,000, representing a 8.9% increase from $13,801,000 in 2023[432]. - Product revenue increased to $7,874,000 in 2024, up 25.6% from $6,270,000 in 2023[432]. - Service revenue decreased to $7,157,000 in 2024, down 5% from $7,531,000 in 2023[432]. - Gross profit for 2024 was $9,019,000, compared to $8,271,000 in 2023, reflecting a gross margin improvement[432]. - Operating loss narrowed to $11,171,000 in 2024 from $17,296,000 in 2023[432]. - Net loss for 2024 was $11,136,000, 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, compared to $11.14 in 2023, showing a substantial improvement[564]. Cash and Assets - Cash and cash equivalents increased to $6,260,000 at the end of 2024, up from $1,643,000 at the end of 2023[438]. - Total assets grew to $15,284,000 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 $7,954,000 in 2024 from $411,000 in 2023, reflecting improved financial health[430]. - As of December 31, 2024, the company had approximately $6.3 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 $0.5 million[518]. - The December 2024 Offering raised approximately $3.5 million, with offering expenses of about $0.5 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 $0.1 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 $0.8 million, down from $1.1 million in 2023[544].

Year over year product revenue increased 26% Operating expenses declined 21% and year over year operating loss decreased 35% Management to Host Conference Call today at 5:00 pm ET Revenue increased approximately $1.2 million, or 9%, to $15.0 million for the full year ended December 31, 2024, compared to $13.8 million for the year ended December 31, 2023. The increase in revenue was mainly due to higher product revenue offset by decreased revenue from fewer Vivos Integrated Practice (VIP) enrollments, which ...

Core Viewpoint - Vivos Therapeutics, Inc. is set to release its full year 2024 financial results on March 31, 2025, and will hold a conference call to discuss these results and recent developments [1] Company Overview - Vivos Therapeutics, Inc. specializes in medical devices and technology for treating sleep-related breathing disorders, including obstructive sleep apnea (OSA) and snoring in adults, as well as moderate to severe OSA in children aged 6 to 17 [1][4] - The Vivos Method is a clinically effective, nonsurgical, noninvasive, and cost-effective solution for treating OSA, having been proven effective in approximately 58,000 patients treated worldwide by over 2,000 trained dentists [4][5] Treatment Methodology - The Vivos Method employs proprietary CARE appliance therapy and other modalities to alter the size, shape, and position of the jaw and soft tissues in the upper airway, significantly reducing symptoms associated with OSA [5] - Vivos also markets SleepImage diagnostic technology for home sleep testing under its VivoScore program, and offers training and services to dentists through its Vivos Integrated Practice (VIP) program [5] Conference Call Details - The conference call to discuss the financial results will take place at 5:00 p.m. (Eastern Time) on March 31, 2025, with access available via phone and a live webcast on the company's website [1][2][3]

Core Insights - Vivos Therapeutics is expanding its alliance model into two additional locations in Colorado, driven by patient preference for Vivos CARE treatment over CPAP by nearly 2 to 1 [1][3] - The company is actively seeking further alliances or acquisitions of sleep medicine practices to support its national expansion goals [1][10] Group 1: Expansion and Strategic Alliances - Vivos has announced the expansion of its strategic marketing and distribution alliance with Rebis Health into two new facilities in the greater Denver area, with plans for further nationwide expansion [2] - The company is exploring alliances or acquisitions of over 2,500 accredited sleep medicine and testing groups across major U.S. cities to enhance revenue growth and reduce cash burn [10] Group 2: Patient Preference and Treatment Efficacy - Initial data from the alliance indicates a Vivos treatment case acceptance rate of 64%, significantly higher than the acceptance of CPAP [3] - Vivos CARE treatment offers advantages over CPAP, including the potential for rehabilitation of airway functionality and symptom reduction, with many patients not requiring further intervention after treatment [5] Group 3: Financial Performance and Revenue Potential - The average revenue per case for Vivos is over $4,700, with gross margins around 70%, indicating a potential for significantly higher profitability compared to previous distribution models [7] - The company anticipates that revenue growth will accelerate starting in 2025 as patient acceptance of Vivos treatment options continues to rise [9]

Core Insights - Vivos Therapeutics, Inc. is a medical device and technology company focused on developing proprietary treatments for sleep-related breathing disorders, particularly obstructive sleep apnea (OSA) and snoring in both adults and children [1][3] - The company is transitioning to a medical-based business model and is actively seeking partnerships with physician-based sleep groups to enhance its market presence [2][4] Company Overview - Vivos Therapeutics specializes in innovative diagnostic and treatment methods for breathing and sleep issues caused by dentofacial abnormalities, with a focus on the Vivos Method, which is a non-surgical and non-invasive solution for OSA [3][4] - The Vivos Method has been clinically effective for over 47,000 patients treated globally by more than 2,000 trained dentists [3] Product and Treatment Details - The Vivos Method employs proprietary CARE appliance therapy to modify the jaw and soft tissues of the upper airway, significantly reducing symptoms associated with OSA [4] - Vivos also offers SleepImage diagnostic technology for home sleep testing and provides training and services to dentists through its Vivos Integrated Practice (VIP) program [4] Upcoming Events - CEO Kirk Huntsman will participate in a fireside chat to discuss the company's strategies, market dynamics, and the role of Vivos CARE devices in OSA treatment [1][2]

Core Viewpoint - Vivos Therapeutics, Inc. has announced a registered direct offering of 709,220 shares of common stock at a price of $4.935 per share, along with a concurrent private placement of short-term warrants to purchase the same number of shares at an exercise price of $4.81 per share [1][2]. Group 1: Offering Details - The gross proceeds from the offering are expected to be approximately $3.5 million before deducting fees and expenses [2]. - If fully exercised, the short-term warrants could provide an additional gross proceeds of approximately $3.4 million [2]. - The closing of the offering is anticipated to occur on or about December 24, 2024, pending customary closing conditions [1]. Group 2: Company Background - Vivos Therapeutics specializes in developing and commercializing treatments for sleep-related breathing disorders, including obstructive sleep apnea (OSA) and snoring in both adults and children [1][10]. - The Vivos Method is a clinically effective, non-surgical, non-invasive, and cost-effective solution for treating OSA, having been proven effective in over 47,000 patients worldwide [10][11]. - The company also markets SleepImage diagnostic technology for home sleep testing and offers training and services to dentists through its Vivos Integrated Practice (VIP) program [12].

Core Viewpoint - Vivos Therapeutics, Inc. (VVOS) has been upgraded to a Zacks Rank 2 (Buy), indicating a positive outlook based on rising earnings estimates, which significantly influence stock prices [1][3]. Earnings Estimates and Stock Performance - The Zacks rating system tracks the Zacks Consensus Estimate, which reflects EPS estimates from sell-side analysts for the current and following years, highlighting the importance of earnings revisions in stock valuation [1][4]. - A strong correlation exists between changes in earnings estimates and near-term stock price movements, driven by institutional investors who adjust their valuations based on these estimates [4][5]. Recent Developments for Vivos Therapeutics - For the fiscal year ending December 2024, Vivos Therapeutics is expected to earn -$1.79 per share, representing an 86.3% change from the previous year's reported figure [8]. - Over the past three months, the Zacks Consensus Estimate for Vivos Therapeutics has increased by 42.8%, reflecting a positive trend in earnings expectations [8]. Zacks Rank System - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with Zacks Rank 1 (Strong Buy) stocks historically generating an average annual return of +25% since 1988 [7]. - The upgrade of Vivos Therapeutics to a Zacks Rank 2 places it in the top 20% of Zacks-covered stocks, indicating a strong potential for market-beating returns in the near term [10][11].

Financial Data and Key Metrics Changes - Total revenue for Q3 2024 was $3.9 million, a 17% increase from $3.3 million in Q3 2023, driven by higher sales of Vivos appliances and lower discounts [14][40] - Gross profit increased to $2.3 million, a 34% rise compared to Q3 2023, with gross margin improving to 60% from 53% [24][40] - Net loss for Q3 2024 increased by 25% to $2.6 million, primarily due to a change in the fair value of a warrant liability [31] Business Line Data and Key Metrics Changes - Product revenue increased by 34% in Q3 2024, with 1,954 oral appliance arches sold, compared to 1,809 in Q3 2023 [20][40] - VIP enrollment revenue decreased by 6% to $900,000 in Q3 2024, with only five VIPs enrolled compared to 29 in Q3 2023 [16][40] - Billing Intelligence Service revenue remained relatively unchanged, with a noted shift in marketing and distribution strategy impacting future VIP enrollment revenue [15][40] Market Data and Key Metrics Changes - The company is focusing on expanding its market presence through strategic alliances with sleep and breathing disorder treatment providers, which is expected to broaden access to Vivos products [22][40] - The new marketing model is anticipated to increase patient access and revenue, with expectations of nearly $8 million in annual revenue for every 100 OSA patients treated [49][50] Company Strategy and Development Direction - The company is transitioning to a new sales and distribution model that emphasizes collaborations with sleep centers, aiming to enhance revenue per clinical case and overall profitability [47][40] - Recent FDA clearances for treating severe OSA in both adults and children are expected to enhance product credibility and broaden market opportunities [43][55] - The company is actively hiring marketing firms to expand outreach and awareness of its FDA-cleared technology [44][40] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the new strategic model's potential to drive revenue growth, with expectations for significant improvements in Q1 2025 [42][106] - The transition quarter is expected to show slight growth, with a more substantial increase anticipated in the following quarters as the new model gains traction [80][106] - Management highlighted the importance of educating healthcare professionals about sleep apnea to increase referrals and patient engagement [68][70] Other Important Information - Cash and cash equivalents increased to approximately $6.3 million as of September 30, 2024, compared to $1.6 million at the end of 2023 [37] - The company has reduced operating expenses for nine consecutive quarters, with a 21% decrease in operating expenses year-over-year [30][41] Q&A Session Summary Question: Insights on the new marketing model at the sleep clinic - Management noted high levels of patient interest and provider enthusiasm, indicating confidence in expanding to additional locations [58][60] Question: Integration of pediatric population into marketing - Management explained that there is a natural cross-pollination effect where parents inquire about treatments for their children, and efforts are underway to educate professionals about sleep issues in children [66][68] Question: Path to positive cash flow from operations - Management indicated that revenue growth will be the primary driver for reaching positive cash flow, with the new model expected to generate higher revenue per patient [73][76] Question: Expectations for Q4 sequentially from Q3 - Management described Q4 as a transition quarter, with a blend of revenue sources as the new model is implemented [80][106] Question: Future geographic expansion plans - Management confirmed active engagement in laying groundwork for national rollout leveraging telemedicine opportunities [90] Question: Clarification on the number of active sleep centers - Management confirmed one active location in Colorado with two additional locations opening soon, with ongoing discussions for further expansions [93]

Financial Performance - Revenue for Q3 2024 was $3.9 million, a 17% increase compared to $3.3 million in Q3 2023[2] - Gross profit for Q3 2024 was $2.3 million, up from $1.7 million in Q3 2023, reflecting the revenue increase[3] - Gross margin improved to 60% in Q3 2024, compared to 53% in Q3 2023[4] - Product revenue for September 2024 reached $1,958,000, an increase of 33.6% compared to $1,466,000 in September 2023[21] - Total revenue for the quarter was $3,860,000, up 17% from $3,301,000 in the same quarter last year[21] - Gross profit for September 2024 was $2,334,000, representing a 33.5% increase from $1,747,000 in September 2023[21] - Net loss for September 2024 was $(2,616,000), compared to $(2,093,000) in September 2023[21] - Net loss per share (basic and diluted) improved to $(0.40) from $(1.75) year-over-year[21] Operating Expenses - Operating expenses decreased by $0.4 million, or 8%, year-over-year in Q3 2024, marking the ninth consecutive quarter of reductions[5] - Total operating expenses decreased to $4,979,000 from $5,387,000 year-over-year, a reduction of 7.6%[21] - The company reported a decrease in general and administrative expenses to $4,487,000 from $4,596,000 year-over-year[21] Operating Loss - Operating loss decreased by $1 million, or 27%, year-over-year in Q3 2024, with a 36% reduction for the nine months ended September 30, 2024[6] - The operating loss for the quarter was $(2,645,000), an improvement from $(3,640,000) in the prior year[21] Market Expansion - As of September 30, 2024, over 47,000 patients have been treated with Vivos' oral appliances, up from over 40,000 a year earlier[8] - Vivos received FDA 510(k) clearance for its oral medical device to treat moderate to severe OSA in children aged 6 to 17, potentially expanding its market[9] - New CPT medical codes applicable to Vivos CARE devices will take effect on January 1, 2025, which may lead to wider adoption and increased revenue[10] Cash and Equity - Cash and cash equivalents as of September 30, 2024, were $6.3 million, significantly up from $1.6 million at the end of 2023[7] - Stockholders' equity increased to $7.7 million as of September 30, 2024, compared to $0.4 million at the end of 2023[20] Share Information - The weighted average number of shares outstanding increased to 6,615,320 from 1,197,258 in the same quarter last year[21] Service Revenue - Service revenue for September 2024 was $1,902,000, slightly up from $1,835,000 in September 2023[21]

Financial Performance - Total revenue for September 2024 was $3,860,000, an increase of 16.9% compared to $3,301,000 in September 2023[12] - Product revenue reached $1,958,000 in September 2024, up 33.5% from $1,466,000 in the same period last year[12] - Service revenue was $1,902,000 for September 2024, slightly up from $1,835,000 in September 2023[12] - Gross profit for the quarter was $2,334,000, 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 $2,645,000 in September 2024 from $3,640,000 in September 2023[12] - Net loss for the quarter was $2,616,000, 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 $11.333 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 $1.958 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 $1.902 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 $6,311,000 as of September 30, 2024, from $1,643,000 at the end of 2023[10] - Total assets grew to $15,347,000 as of September 30, 2024, compared to $10,730,000 at the end of 2023[11] - Total liabilities decreased to $7,682,000 from $10,319,000 at the end of 2023, indicating improved financial health[11] - Stockholders' equity increased to $7,665,000 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, 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 $9,751,000 for the nine months ended September 30, 2024, compared to $9,198,000 for the same period in 2023[15] - The company recognized approximately $0.7 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 $2.613 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 $1.5 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 $7.5 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 $7.4 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]