Core Insights - Vivos Therapeutics has received approval from the Centers for Medicare & Medicaid Services (CMS) for its VidaSleep™ oral appliance, which is designed to treat mild to moderate obstructive sleep apnea (OSA) and snoring in adults [1][4][5] - The approval allows Vivos to significantly expand its market presence, as it now has two Medicare-covered oral appliances, enhancing its competitive position in the sleep therapy market [5][6] Company Overview - Vivos Therapeutics, Inc. is a medical technology company focused on innovative treatments for OSA and snoring, with its products cleared by the FDA for various severity levels of OSA [10][12] - The company aims to address the structural root causes of OSA through its proprietary oral appliances, which are non-invasive and non-pharmaceutical [13] Market Opportunity - With over 80% of OSA cases in the U.S. undiagnosed and an estimated 80 million Americans affected, Vivos is positioned to capture a significant share of the underpenetrated sleep therapy market [4][11] - The dual-PDAC approval of VidaSleep™ and mmRNA® appliances allows Vivos to serve a broader range of patients, from Medicare beneficiaries to those covered by commercial payers, tapping into the estimated $36 billion sleep therapy market [6][8] Clinical and Commercial Advantages - The VidaSleep™ device is designed to be a standalone therapy or an adjunct to CPAP, providing flexibility for both providers and patients [7][8] - The streamlined design and efficient manufacturing process of VidaSleep™ enable Vivos to offer high-impact therapy at a cost-effective price, increasing adoption across Medicare and commercial insurance networks [8] Health Implications - OSA is linked to severe comorbidities such as heart disease, stroke, and dementia, yet remains largely underdiagnosed [9][11] - Vivos' oral appliances have shown significant improvements in airway patency and symptom resolution, as evidenced by peer-reviewed studies [9]

Core Insights - Vivos Therapeutics has announced a significant study published in the European Journal of Pediatrics, demonstrating the safety and efficacy of its Daytime-Nighttime Appliance (DNA) for treating obstructive sleep apnea (OSA) in children [1][2] - The study indicates that 79% of participants showed improvement in OSA symptoms, with 61.7% improving by 50% or more, and 17% experiencing complete resolution of their OSA [3] - The findings support Vivos' FDA 510(k) clearance for the DNA device, reinforcing its position as a non-surgical alternative to traditional adenotonsillectomy surgery [2][7] Company Overview - Vivos Therapeutics, Inc. is focused on developing non-invasive treatments for OSA, with its DNA device being a key product cleared for use in children aged 6 to 17 [9][12] - The company aims to address the significant number of undiagnosed OSA cases among children, estimated at 10 million in the U.S., with many linked to various health issues [5][10] - Vivos is actively pursuing collaborations and acquisitions to expand access to its treatments, including the recent acquisition of the Sleep Center of Nevada [9][11] Industry Context - The current standard treatment for pediatric OSA is adenotonsillectomy, with over 500,000 surgeries performed annually in the U.S., but with a high relapse rate of 68% within three years [6][7] - The study highlights the need for safer, evidence-based alternatives to invasive procedures, aligning with recent reports warning against overtreatment in pediatric healthcare [7][8] - Vivos' approach offers a non-invasive solution that promotes natural jaw development, potentially reducing the need for costly and traumatic surgeries [7][8]

Core Insights - Vivos Therapeutics has completed the acquisition of The Sleep Center of Nevada (SCN), enhancing its diagnostic revenue and expanding its treatment options for obstructive sleep apnea (OSA) patients in the Las Vegas area [1][2] - The acquisition marks a strategic pivot in Vivos' business model, shifting focus from dental providers to collaborations with medical sleep practices, allowing for immediate revenue capture from OSA diagnostics and consultations [3][6] - Vivos has secured over $11 million in financing, including a senior secured loan and an equity private placement, to support the integration of SCN and future growth initiatives [9][11] Acquisition Details - The SCN transaction is Vivos' first major acquisition of a sleep testing center, expected to generate higher-margin revenue from both diagnostics and sales of Vivos' OSA treatment devices [2][5] - SCN serves approximately 3,000 new patients monthly and has generated annual net revenues in the high seven-figure range, making it the largest sleep testing center in Nevada [5][6] - Vivos will manage SCN's operations and capture diagnostic and consulting revenues, with plans to expand treatment offerings across additional SCN locations over the next 12 to 18 months [7][11] Financial Aspects - The acquisition involved a cash payment of $6 million and $1.5 million in Vivos common stock, with potential future stock payments based on financial milestones [8] - Vivos financed the acquisition through an $8.225 million senior secured loan, which includes a $675,000 original issuance discount, and an additional $3.755 million equity investment from New Seneca Partners [9][10] - The financing will provide essential cash resources for Vivos to integrate SCN and pursue further growth opportunities [11] Strategic Outlook - Vivos is actively seeking additional collaborations or acquisitions to further expand its business in 2025 and beyond [4] - The company anticipates significant benefits from the SCN acquisition, including reduced cash burn and a move towards cash flow positivity as patient volumes increase [12]

Company Performance - Vivos Therapeutics, Inc. reported a quarterly loss of $0.45 per share, slightly worse than the Zacks Consensus Estimate of a loss of $0.44, and an improvement from a loss of $1.63 per share a year ago [1] - The company posted revenues of $3.02 million for the quarter, missing the Zacks Consensus Estimate by 18.49%, and down from $3.42 million in the same quarter last year [2] - Over the last four quarters, Vivos Therapeutics has surpassed consensus EPS estimates two times, but has not beaten consensus revenue estimates [2] Stock Performance - Vivos Therapeutics shares have declined approximately 29.1% since the beginning of the year, contrasting with the S&P 500's gain of 0.2% [3] - The current Zacks Rank for Vivos Therapeutics is 5 (Strong Sell), indicating expectations for the stock to underperform the market in the near future [6] Earnings Outlook - The current consensus EPS estimate for the upcoming quarter is -$0.39 on revenues of $4.2 million, and for the current fiscal year, it is -$1.54 on revenues of $16.6 million [7] - The trend for estimate revisions ahead of the earnings release has been unfavorable, which may impact future stock performance [6] Industry Context - The Medical - Drugs industry, to which Vivos Therapeutics belongs, is currently ranked in the top 26% of over 250 Zacks industries, suggesting a relatively strong industry performance [8]

Financial Data and Key Metrics Changes - Total revenue for Q1 2025 was $3 million, down from $3.4 million in Q1 2024, primarily due to lower service revenue from VIP enrollments [20] - Product sales increased by approximately $100,000, while sponsorship, conference, and training revenue rose by $200,000 [20] - Gross profit decreased to $1.5 million in Q1 2025 from $1.9 million in Q1 2024, with gross margin dropping to 50% from 57% [21][22] - Operating loss for Q1 2025 was approximately $3.9 million, slightly higher than the $3.8 million loss in Q1 2024 [24] Business Line Data and Key Metrics Changes - Service revenues declined as the company eliminated its VIP enrollment sales team, while product sales, particularly in pediatric guide appliances, grew significantly, with total arches shipped increasing by 87% [8][20] - The billing intelligence service and myofunctional therapy service revenue remained unchanged at $200,000 for both Q1 2024 and Q1 2025 [20] Market Data and Key Metrics Changes - The company is expecting to close the acquisition of Sleep Center of Nevada (SCN) soon, which sees approximately 3,000 sleep patients monthly, with a significant percentage testing positive for obstructive sleep apnea (OSA) [9][12] - The acquisition is anticipated to be accretive to revenue and gross profit shortly after closing [9] Company Strategy and Development Direction - The company is pivoting to create strategic alliances or acquisitions of sleep medical providers to drive sales of OSA treatment appliances and diversify revenue streams [7][8] - The management believes that the SCN acquisition will be transformational, providing a fast track to increase patient treatment and revenue [10][11] - The company is actively exploring additional acquisition opportunities in the sleep medicine sector, with positive reception from the sleep medicine community [16][17] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the new business model and its potential for growth, emphasizing the importance of the SCN acquisition [7][10] - The management team has learned valuable lessons from previous partnerships, which will inform future negotiations and operational strategies [36] Other Important Information - The company has signed a non-binding term sheet for a $7.5 million senior loan to facilitate the SCN acquisition and working capital [9] - Cash used in operations for Q1 2025 was $3.8 million, an increase from $2.5 million in Q1 2024 [24][25] Q&A Session Summary Question: Can you expand on the experience with the Rebus Alliance? - The partnership has progressed slower than expected due to internal issues at Rebus, but the company has proven its thesis that a significant percentage of patients prefer VIVOS treatments over CPAP [28][30] Question: What can be learned from the Rebus experience for future partnerships? - The management has learned to optimize revenue and services in a medical insurance-oriented environment, which will be applied to future partnerships [36] Question: What is the expected impact of the SCN acquisition on the P&L? - The acquisition is expected to add significant revenue and become accretive by Q3 2025, with immediate revenue generation from diagnostic services [44][49] Question: How was the acquisition price of $9 million determined? - The valuation was based on a quality of earnings report and the potential patient volume from SCN, with a fair price offered to the current owners [53][56]

Financial Data and Key Metrics Changes - Total revenue for Q1 2025 was $3 million, down from $3.4 million in Q1 2024, primarily due to lower service revenue from VIP enrollments [20] - Gross profit decreased to $1.5 million in Q1 2025 from $1.9 million in Q1 2024, with a gross margin of 50% compared to 57% in the prior year [21][22] - Net loss for Q1 2025 was $3.9 million, slightly higher than the $3.8 million loss in Q1 2024 [24] Business Line Data and Key Metrics Changes - Service revenues declined as the company eliminated its VIP enrollment sales team, while product sales increased by 8% due to higher volume in pediatric guide appliances [9][20] - The number of oral appliance arches shipped increased by 87%, from 1,996 in Q1 2024 to 3,736 in Q1 2025 [9] Market Data and Key Metrics Changes - The company is expecting to close the acquisition of Sleep Center of Nevada (SCN), which sees approximately 3,000 sleep patients a month, in the next month or two [10][12] - The acquisition is anticipated to be accretive to revenue and gross profit, with a projected net contribution margin of 50% or better from SCN [14] Company Strategy and Development Direction - The company is pivoting to create strategic alliances or acquisitions of sleep medical providers to drive sales of OSA treatment appliances and diversify revenue streams [8][12] - The management believes that the SCN acquisition will be transformational, providing a fast path to increase patient treatment and revenue [12][16] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the new business model and the potential for significant cash flow and profitability by the end of 2025 [15][47] - The management team has extensive experience in acquiring and integrating professional practices, which they believe will facilitate successful future acquisitions [17][36] Other Important Information - The company has signed a non-binding term sheet for a $7.5 million senior loan to finance the SCN acquisition and working capital [10] - Cash used in operations for Q1 2025 was $3.8 million, an increase from $2.5 million in Q1 2024 [24][25] Q&A Session Summary Question: Can you expand on the experience with the Rebus Alliance and its contribution? - The experience with Rebus has been slower than expected due to internal challenges, but the company proved its thesis that a significant percentage of patients would choose VIVOS treatments over CPAP [28][30] Question: What can be learned from the Rebus experience for future partnerships? - The management has learned to optimize revenues and services in a medical insurance environment and has modified deal structures to ensure a steady patient flow [34][36] Question: What is the expected impact of the SCN acquisition on the P&L? - The SCN acquisition is expected to add legacy revenue and expenses, with the potential for significant revenue generation starting in Q3 2025 [43][47] Question: Will operating expenses increase in Q3 and Q4 due to the acquisition? - Yes, there will be an uptick in operating expenses due to hiring and training new staff, but revenues are expected to quickly outpace these costs [49][50] Question: How was the acquisition price of $9 million determined? - The valuation was based on a quality of earnings report and the potential patient volume from SCN, with a combination of cash and equity as part of the deal [51][56]

[Financial & Operational Highlights](index=1&type=section&id=First%20Quarter%202025%20Financial%20and%20Operating%20Summary) Vivos Therapeutics reported decreased total revenue but increased product revenue in Q1 2025, with reduced operating expenses Q1 2025 Key Financial Metrics (vs. Q1 2024) | Metric | Q1 2025 | Q1 2024 | Change | | :--- | :--- | :--- | :--- | | **Total Revenue** | $3.0 million | $3.4 million | -11.8% | | *Product Revenue* | *$1.8 million* | *$1.7 million* | *+8%* | | *Service Revenue* | *$1.2 million* | *$1.7 million* | *-29.5%* | | **Gross Profit** | $1.5 million | $1.9 million | -21.1% | | **Gross Margin** | 50% | 57% | -7 p.p. | | **Operating Expenses** | $5.4 million | $5.7 million | -5% | | **Net Loss** | $3.9 million | $3.8 million | +3% | - The decline in total revenue was expected and is attributed to the company's strategic pivot away from Vivos Integrated Provider (VIP) service revenue towards a new marketing and sales strategy[3](index=3&type=chunk)[4](index=4&type=chunk) Q1 2025 Operational & Balance Sheet Highlights | Metric | As of/For Q1 2025 | As of/For Q1 2024 | | :--- | :--- | :--- | | Oral Appliance Arches Sold | 3,736 | 1,996 | | Revenue from Arches | ~$1.8 million | $1.7 million | | Cash and Cash Equivalents | $2.3 million | N/A | | Stockholders' Equity | $4.4 million | N/A | [Management Commentary](index=2&type=section&id=Management%20Commentary) Management emphasizes operational streamlining, the SCN acquisition, and new CPT codes as key drivers for future growth - The acquisition and integration of SCN are expected to showcase Vivos' transformation and provide access to thousands of OSA patients[5](index=5&type=chunk) - The implementation of CPT medical codes in January 2025 is a significant achievement that simplifies reimbursement and billing for providers and patients[5](index=5&type=chunk) - Vivos is actively engaging with potential partners for profit-sharing alliances and acquisitions of sleep medical practices to expand patient access and diversify revenue streams[5](index=5&type=chunk) [Strategic Initiatives](index=1&type=section&id=Strategic%20Initiatives) Vivos pivots from its legacy VIP model to direct sales and acquisitions, with the SCN acquisition central to expanding patient access - The company is shifting from its legacy VIP fee revenue model to a new marketing and distribution model focused on direct sales and provider partnerships[3](index=3&type=chunk) - On April 15, 2025, Vivos entered a definitive agreement to acquire the operating assets of The Sleep Center of Nevada (SCN) for up to **$9 million** in cash and stock[8](index=8&type=chunk) - The SCN acquisition is a key part of the new strategy, as SCN sees thousands of potential OSA patients monthly who could be candidates for Vivos' treatments, with the transaction expected to close within two months of the announcement[8](index=8&type=chunk) [Financial Statements](index=5&type=section&id=Financial%20Statements) The financial statements detail the company's balance sheet and operational performance for the first quarter of 2025 [Unaudited Condensed Consolidated Balance Sheets](index=5&type=section&id=Unaudited%20Condensed%20Consolidated%20Balance%20Sheets) The balance sheet reflects decreased total assets and stockholders' equity as of March 31, 2025, primarily from reduced cash Condensed Consolidated Balance Sheets (In Thousands) | | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **ASSETS** | | | | Cash and cash equivalents | $2,342 | $6,260 | | Total current assets | $3,607 | $7,473 | | Total assets | **$11,282** | **$15,284** | | **LIABILITIES & EQUITY** | | | | Total current liabilities | $4,701 | $4,978 | | Total liabilities | $6,875 | $7,330 | | Total stockholders' equity | $4,407 | $7,954 | | **Total liabilities and stockholders' equity** | **$11,282** | **$15,284** | [Unaudited Condensed Consolidated Statements of Operations](index=6&type=section&id=Unaudited%20Condensed%20Consolidated%20Statements%20of%20Operations) The statement of operations shows decreased total revenue, a shifted revenue mix, reduced operating expenses, and a slight net loss increase Condensed Consolidated Statements of Operations (In Thousands, Except Per Share Amounts) | | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Product revenue | $1,813 | $1,674 | | Service revenue | $1,203 | $1,745 | | **Total revenue** | **$3,016** | **$3,419** | | Gross profit | $1,509 | $1,937 | | Total operating expenses | $5,427 | $5,722 | | Operating loss | $(3,918) | $(3,785) | | **Net loss** | **$(3,864)** | **$(3,763)** | | Net loss per share (basic and diluted) | $(0.45) | $(1.63) | [About Vivos Therapeutics, Inc.](index=3&type=section&id=About%20Vivos%20Therapeutics%2C%20Inc.) Vivos Therapeutics is a medical technology company specializing in non-surgical, FDA-cleared treatments for obstructive sleep apnea - Vivos is a medical technology company specializing in diagnostics and treatments for sleep issues like obstructive sleep apnea (OSA)[10](index=10&type=chunk) - The company's CARE devices are the only FDA 510(k) cleared technology for treating severe OSA in adults and the first oral device cleared for moderate to severe OSA in children[10](index=10&type=chunk) - The Vivos Method provides a nonsurgical, noninvasive, and nonpharmaceutical solution for patients[13](index=13&type=chunk) [Conference Call Information](index=3&type=section&id=Conference%20Call) Details for the investor conference call held on May 15, 2025, including replay and webcast archive availability - An investor conference call was held at 5:00 p.m. Eastern time on the day of the release[9](index=9&type=chunk) - A telephone replay is available until May 29, 2025, and a webcast is archived on the company's website[9](index=9&type=chunk)

Core Insights - Vivos Therapeutics reported an 8% year-over-year increase in product revenue and a 5% decrease in operating expenses, indicating a strategic shift towards a new marketing and distribution model [1][6][3] - The company is in the process of acquiring The Sleep Center of Nevada, which is expected to enhance its market presence and patient access to its products [3][6][5] Financial Performance - Total revenue for Q1 2025 was $3.0 million, down from $3.4 million in Q1 2024, primarily due to a decline in service revenue as the company pivots away from its legacy VIP model [6][21] - Product revenue increased to $1.8 million from $1.7 million year-over-year, with a total of 3,736 oral appliance arches sold in Q1 2025 compared to 1,996 in Q1 2024 [6][21] - Gross profit for Q1 2025 was $1.5 million, down from $1.9 million in the same period last year, leading to a gross margin decrease from 57% to 50% [6][21] - Operating expenses decreased to $5.4 million from $5.7 million year-over-year, reflecting cost-cutting measures [6][21] Strategic Initiatives - The company is focusing on direct sales of its FDA-cleared OSA treatments and is pursuing strategic alliances and acquisitions of sleep-focused medical practices [3][5] - The implementation of CPT medical codes for its CARE oral medical devices is expected to simplify reimbursement processes, potentially increasing adoption among providers [5] - Vivos is engaging in discussions with several potential provider partners to expand its reach and diversify revenue streams [5][6] Market Position - Vivos aims to lead the industry in innovative treatments for obstructive sleep apnea (OSA), leveraging cutting-edge technology and strategic partnerships [7] - The acquisition of The Sleep Center of Nevada is anticipated to provide access to thousands of OSA patients monthly, significantly enhancing the company's market potential [6][3]

[Cautionary Note Regarding Forward-Looking Statements](index=3&type=section&id=Cautionary%20Note%20Regarding%20Forward-Looking%20Statements) This section highlights forward-looking statements, primarily in the MD&A, cautioning that actual results may differ due to risks related to business model execution, product adoption, financial viability, and market conditions - The company's forward-looking statements cover critical aspects of its strategy and operations, including[8](index=8&type=chunk) - **Business Model Execution**: Ability to establish and grow its new marketing and distribution model, including acquiring or forming alliances with sleep treatment centers, such as the pending acquisition of The Sleep Center of Nevada[9](index=9&type=chunk) - **Product Adoption**: Acceptance of its proprietary oral appliances by healthcare professionals for treating OSA and other conditions[9](index=9&type=chunk) - **Financial Viability**: Ability to generate cash flow, achieve profitability, and continue as a going concern, along with future financing plans[12](index=12&type=chunk) - **Market Conditions**: Capacity to adapt to changing market conditions, including volatile capital markets[12](index=12&type=chunk) [PART I. FINANCIAL INFORMATION](index=5&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Condensed Consolidated Financial Statements (Unaudited)](index=5&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements%20(Unaudited)) The unaudited condensed consolidated financial statements for Q1 2025 reveal a net loss of $3.9 million and reduced cash to $2.3 million, indicating a weakened financial position and raising substantial doubt about the company's going concern [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of March 31, 2025, total assets decreased to $11.3 million from $15.3 million, mainly due to reduced cash, while total liabilities slightly decreased to $6.9 million and stockholders' equity fell to $4.4 million Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $2,342 | $6,260 | | Total current assets | $3,607 | $7,473 | | Total assets | $11,282 | $15,284 | | **Liabilities & Equity** | | | | Total current liabilities | $4,701 | $4,978 | | Total liabilities | $6,875 | $7,330 | | Accumulated deficit | $(108,051) | $(104,187) | | Total stockholders' equity | $4,407 | $7,954 | [Condensed Consolidated Statements of Operations](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) For Q1 2025, total revenues decreased to $3.0 million from $3.4 million in Q1 2024, resulting in a net loss of $3.9 million, slightly higher than the $3.8 million loss in the prior year Consolidated Statements of Operations (in thousands, except per share data) | Metric | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Product revenue | $1,813 | $1,674 | | Service revenue | $1,203 | $1,745 | | **Total revenue** | **$3,016** | **$3,419** | | Gross profit | $1,509 | $1,937 | | Operating loss | $(3,918) | $(3,785) | | **Net loss** | **$(3,864)** | **$(3,763)** | | Net loss per share (basic and diluted) | $(0.45) | $(1.63) | [Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities significantly increased to $3.8 million in Q1 2025, with no financing activities, leading to a $3.9 million decrease in cash and equivalents, ending at $2.3 million Consolidated Statements of Cash Flows Highlights (in thousands) | Activity | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(3,796) | $(2,516) | | Net cash used in investing activities | $(122) | $(151) | | Net cash provided by financing activities | $- | $3,635 | | **Net (decrease) increase in cash** | **$(3,918)** | **$968** | | Cash and cash equivalents at end of period | $2,342 | $2,611 | [Notes to the Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20the%20Condensed%20Consolidated%20Financial%20Statements) Key notes detail a strategic pivot from the VIP enrollment model to sleep center acquisitions, highlight a significant going concern risk due to recurring losses, and disclose the planned $9.0 million acquisition of The Sleep Center of Nevada - The company is pivoting its business strategy away from its prior dependence on enrolling dentists (VIPs) towards a model focused on contractual alliances with and acquisitions of sleep specialty providers and centers[33](index=33&type=chunk) - There is substantial doubt about the company's ability to continue as a going concern, as its **$2.3 million cash** balance as of March 31, 2025, is insufficient to fund operations for the next twelve months without additional financing[76](index=76&type=chunk)[73](index=73&type=chunk) - Subsequent to quarter-end, on April 15, 2025, the company agreed to acquire The Sleep Center of Nevada (SCN) for **$6.0 million in cash**, **$1.5 million in restricted stock**, and **$1.5 million in contingent earn-out stock**[129](index=129&type=chunk) Revenue Breakdown (in thousands) | Revenue Source | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | **Product Revenue** | | | | Appliances | $1,273 | $1,145 | | Guides | $540 | $529 | | **Service Revenue** | | | | VIP | $223 | $907 | | Billing intelligence services | $181 | $225 | | Sleep testing services | $323 | $307 | | **Total Revenue** | **$3,016** | **$3,419** | [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=26&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the strategic pivot from the VIP enrollment model to acquiring sleep medicine centers, exemplified by the pending SCN acquisition, noting a 12% revenue decrease in Q1 2025 due to reduced VIP recruitment, and acknowledging significant liquidity challenges and going concern risks requiring additional financing - The company has strategically pivoted away from its VIP model, ceasing new VIP dentist recruitment, which is expected to lead to a substantial decline in future VIP enrollment revenue[138](index=138&type=chunk) - A definitive agreement was signed on April 15, 2025, to acquire the assets of Sleep Center of Nevada (SCN), an acquisition expected to drive revenue growth and potential profitability[140](index=140&type=chunk) - The company faces potential Nasdaq delisting risk due to minimum stockholders' equity requirements, despite regaining compliance in July 2024, and maintaining compliance remains a risk[149](index=149&type=chunk)[152](index=152&type=chunk)[153](index=153&type=chunk) Q1 2025 vs Q1 2024 Operations Summary (in thousands) | Metric | Q1 2025 | Q1 2024 | Change | | :--- | :--- | :--- | :--- | | Total Revenue | $3,016 | $3,419 | $(403) | | Gross Profit | $1,509 | $1,937 | $(428) | | Gross Profit % | 50% | 57% | -7% | | Operating Loss | $(3,918) | $(3,785) | $(133) | | Net Loss | $(3,864) | $(3,763) | $(101) | - Revenue decreased by **12%** primarily due to a **$0.7 million (75%) drop** in VIP enrollment revenue, reflecting the strategic shift, partially offset by a small increase in product revenue[159](index=159&type=chunk)[160](index=160&type=chunk) - The company's **$2.3 million cash** as of March 31, 2025, is insufficient to fund operations and strategic objectives, including the **$6 million cash portion** for the SCN acquisition, for the next twelve months, raising substantial doubt about its going concern ability[170](index=170&type=chunk)[171](index=171&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=33&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section is not applicable as the company qualifies as a smaller reporting company - Not applicable to smaller reporting companies[179](index=179&type=chunk) [Controls and Procedures](index=33&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the CEO and CFO, concluded that the company's disclosure controls and procedures were effective as of the period end, with no material changes to internal control over financial reporting during the quarter - The Chief Executive Officer and Chief Financial Officer concluded that the company's disclosure controls and procedures were effective as of March 31, 2025[180](index=180&type=chunk) - No changes in internal control over financial reporting occurred during the quarter that materially affected, or are reasonably likely to materially affect, internal controls[181](index=181&type=chunk) [PART II. OTHER INFORMATION](index=34&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Legal Proceedings](index=34&type=section&id=Item%201.%20Legal%20Proceedings) The company is engaged in ongoing litigation with Ortho-Tain, Inc., involving a suit filed by Vivos in Colorado for false statements and a countersuit by Ortho-Tain in Illinois alleging Lanham Act violations and breach of contract, with both cases proceeding through the legal system - Vivos filed a suit against Ortho-Tain, Inc. in Colorado in June 2020, alleging false statements and interference with a business relationship, with the case currently in the appeals process after a denied motion to dismiss[184](index=184&type=chunk)[185](index=185&type=chunk) - Ortho-Tain, Inc. filed a complaint against Vivos and its CEO in Illinois in July 2020, alleging Lanham Act violations and breach of contract; this case, previously stayed, had its stay lifted in March 2023, and parties are now in the discovery phase[186](index=186&type=chunk)[188](index=188&type=chunk)[190](index=190&type=chunk) [Risk Factors](index=35&type=page&id=Item%201A.%20Risk%20Factors) This section is not applicable as the company qualifies as a smaller reporting company - Not applicable to smaller reporting companies[191](index=191&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=35&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered sales of equity securities or use of proceeds were reported for the period - None[192](index=192&type=chunk) [Other Information](index=35&type=section&id=Item%205.%20Other%20Information) No other information was reported for the period - None[195](index=195&type=chunk) [Exhibits, Financial Statement Schedules](index=36&type=section&id=Item%206.%20Exhibits%2C%20Financial%20Statement%20Schedules) This section lists the exhibits filed with the Quarterly Report on Form 10-Q, including CEO and CFO certifications and Inline XBRL data files

Company Overview - Vivos Therapeutics, Inc. is a medical technology company focused on developing and commercializing innovative diagnostic and treatment methods for sleep-related breathing disorders, particularly obstructive sleep apnea (OSA) and snoring in adults, as well as moderate to severe OSA in children aged 6 to 17 [4] - The company's devices have received FDA clearance for treating all severity levels of OSA in adults and moderate to severe OSA in children [4] - Vivos' CARE devices are the only FDA 510(k) cleared technology for treating severe OSA in adults and the first to receive clearance for treating moderate to severe OSA in children [4] Industry Context - OSA affects over 1 billion people globally, with 90% remaining undiagnosed [5] - The disorder is linked to various serious chronic health conditions, indicating a significant unmet need in the market for effective treatment solutions [5] - Current solutions often fail to address the root causes of OSA, highlighting the importance of innovative approaches like those offered by Vivos [5] Upcoming Events - Vivos plans to release its first quarter 2025 financial results after market close on May 15, 2025, followed by a conference call at 5:00 p.m. ET to discuss the results and recent developments [1] - The conference call can be accessed via a dedicated phone line and will also be available as a live webcast on the company's website [2][3] Innovative Approach - The Vivos Method provides a proprietary, clinically effective solution that is nonsurgical, noninvasive, and nonpharmaceutical, aiming to improve patient outcomes in sleep health [7] - The company collaborates with healthcare providers, including dentists and sleep specialists, to address the complex needs of patients suffering from sleep-related disorders [6]