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]

Financial Data and Key Metrics Changes - Total revenue for Q2 2024 was $4.1 million, a 19% increase compared to $3.4 million in Q2 2023 and Q1 2024 [9][20] - Gross profit increased to $2.7 million in Q2 2024 from $2.1 million in Q2 2023, with a gross margin of 65% compared to 62% [13][20] - Net loss decreased by 65% to $1.9 million in Q2 2024 from $5.5 million in Q2 2023 [16][20] Business Line Data and Key Metrics Changes - Product revenue increased by approximately $400,000 due to higher sales and fewer discounts on Vivos appliances [9] - Service revenue rose by $200,000, driven by an increase in Vivos Integrated Provider (VIP) enrollment revenue [9] - Myofunctional Therapy revenues decreased by $100,000 [9] Market Data and Key Metrics Changes - The company enrolled 32 VIPs in Q2 2024, recognizing VIP enrollment revenue of $1.2 million, a 28% increase from Q2 2023 [10] - The number of oral appliance arches sold in Q2 2024 was 2,033, generating $2 million in revenue, a 28% increase from Q2 2023 [11] Company Strategy and Development Direction - The company is pivoting towards a strategic alliance model with medical professionals to enhance revenue per clinical case and gross profit [22][23] - A new strategic alliance with a multicenter sleep clinic in Colorado was launched, expected to broaden access to OSA patients [12][22] - The company aims to reduce reliance on VIP enrollments and increase patient access through collaborations with sleep testing centers [12][26] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about future growth, citing a significant opportunity in the OSA market with many undiagnosed patients [27][28] - The company anticipates achieving positive cash flow from operations in the foreseeable future [20][29] - Management highlighted the importance of the new strategic model in positioning the company for long-term success [22][29] Other Important Information - The company secured a $7.5 million equity investment to bolster liquidity and support the new strategic alliance [19][28] - Cash and cash equivalents increased to approximately $6.9 million as of June 30, 2024, compared to $1.6 million at the end of 2023 [19][20] Q&A Session Summary Question: Importance of the strategic alliance with the sleep clinic - Management emphasized the significance of the strategic pivot towards medical distribution, moving away from a solely dental channel [30][32] Question: Future of VIP doctors or dentists - Management indicated that there is still a large market for VIP doctors, and they will continue to support and train them [37][40] Question: Details on cost-cutting efforts - Management detailed significant reductions in SG&A costs and operational cash flow, achieved through workforce reductions and cuts in non-essential expenditures [41][42] Question: Revenue increase due to lower discounts - Management explained that the reduction in discounts was a conscious decision to uphold the value proposition of their products [44][45] Question: Steady state for operating expenses - Management noted that operating expenses are still in transition as the company pivots to a new model, making it difficult to define a steady state [48][49]

Vivos Therapeutics, Inc. (NASDAQ:VVOS) Q1 2024 Results Conference Call May 14, 2024 5:00 PM ET Company Participants Julie Gannon - Investor Relations Officer Kirk Huntsman - Chairman & Chief Executive Officer Brad Amman - Chief Financial Officer Conference Call Participants Lucas Ward - Ascendiant Capital Markets Operator Good day, everyone, and welcome to the Vivos Therapeutics First Quarter 2024 Earnings Conference Call. At this time, participants are in a listen-only mode. A question-and-answer session w ...

Exhibit 99.1 Kirk Huntsman, Vivos' Chairman and Chief Executive Officer, stated, "We are proud of the prudent way we have managed our costs and our cash resources as well as our successful efforts to expand our product offerings, gain unprecedented regulatory approvals and obtain Medicare reimbursement for our CARE oral devices. That said, we recognize that our revenues have not grown as we would have liked. To that end, we are announcing today the anticipated launch of a new strategic revenue initiative ba ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Securities registered pursuant to Section 12(b) of the Act: | Title of each class | Trading symbol(s) | Name of exchange on which registered | | --- | --- | --- | | Common stock, par value $0.0001 per share | VVOS | Nasdaq Capital Market | Indicate by check mark whether the registrant (1) has filed all reports required to be fi ...

Vivos Therapeutics, Inc. (NASDAQ:VVOS) Q4 2023 Earnings Conference Call March 28, 2024 5:00 PM ET Company Participants Julie Gannon - Investor Relations Officer Kirk Huntsman - Chairman & Chief Executive Officer Brad Amman - Chief Financial Officer Conference Call Participants Scott Henry - AGP Lucas Ward - Ascendiant Operator Good day, everyone, and welcome to Vivos Therapeutics Fourth Quarter and Full Year 2023 Conference Call. At this time, participants are in a listen-only mode. A question-and-answer s ...

Exhibit 99.1 Positive Business Momentum and Sales Pipeline Growth Following FDA 510(k) Clearance of Vivos' Proprietary Oral Medical Devices to Treat Severe Obstructive Sleep Apnea Annual Operating Expenses Declined 27% Due to Success of Cost Cutting Initiatives Management to Host Conference Call Today at 5:00 pm ET LITTLETON, Colo., March 28, 2024 – Vivos Therapeutics, Inc. ("Vivos" or the "Company'') (NASDAQ: VVOS), a leading medical device and technology company specializing in the development and commerc ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Fiscal Year Ended December 31, 2023 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Transition Period from to Commission File Number: 001-39796 Vivos Therapeutics, Inc. (Exact Name of Registrant as Specified in its Charter) | Delaware | 81-3224056 | | --- | --- | | (State ...