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]

Company Overview - Vivos Therapeutics, Inc. (VVOS) is expected to report a quarterly loss of $0.44 per share, reflecting a year-over-year change of +73% [3] - Revenues are anticipated to be $3.7 million, which is an increase of 8.2% from the same quarter last year [3] Earnings Estimates and Revisions - The consensus EPS estimate has been revised 14.71% lower in the last 30 days, indicating a reassessment by analysts [4] - The Most Accurate Estimate for Vivos is the same as the Zacks Consensus Estimate, resulting in an Earnings ESP of 0% [10][11] Earnings Surprise Prediction - The Zacks Earnings ESP model suggests that a positive or negative reading indicates the likely deviation of actual earnings from the consensus estimate, but its predictive power is significant mainly for positive readings [7] - Vivos currently holds a Zacks Rank of 4, making it challenging to predict an earnings beat [11] Historical Performance - In the last reported quarter, Vivos was expected to post a loss of $0.43 per share but actually reported a loss of $0.28, resulting in a surprise of +34.88% [12] - Over the past four quarters, Vivos has beaten consensus EPS estimates two times [13] Industry Comparison - Ironwood Pharmaceuticals (IRWD), another player in the Zacks Medical - Drugs industry, is expected to report a loss of $0.05 per share, indicating a year-over-year change of -150% [17] - Ironwood's revenues are projected to be $59.45 million, down 20.6% from the previous year [17] - The consensus EPS estimate for Ironwood has been revised 28.6% lower in the last 30 days, with an Earnings ESP of -121.05% [18]

Core Viewpoint - Vivos Therapeutics, Inc. is acquiring The Sleep Center of Nevada to expand its obstructive sleep apnea (OSA) treatment offerings in the Las Vegas area, enhancing its market position and patient access to its FDA-cleared oral appliance treatments [1][3][6]. Company Overview - Vivos Therapeutics, Inc. is a medical technology company focused on developing non-invasive treatments for OSA and related sleep disorders, with FDA-cleared devices for both adults and children [8][10]. - The Sleep Center of Nevada, founded in 2008, is the largest operator of medical sleep centers in Nevada, serving approximately 3,000 new patients monthly and generating high seven-figure annual revenues [4][8]. Acquisition Details - Vivos will pay up to $9 million for SCN's operating assets, including $6 million in cash and $1.5 million in Vivos common stock at closing, with an additional $1.5 million contingent on future financial milestones [5][6]. - The acquisition is expected to close later this quarter or in the third quarter, subject to customary conditions [2][5]. Strategic Implications - The acquisition aligns with Vivos' mission to provide accessible, clinically proven OSA treatments, leveraging SCN's infrastructure to enhance service offerings and patient acceptance [3][6]. - Vivos anticipates that SCN patients will prefer its treatment options over traditional CPAP devices, as evidenced by a previous strategic alliance where two-thirds of OSA patients chose Vivos treatments [6][7]. Market Context - OSA affects over 1 billion people globally, with a significant portion undiagnosed, indicating a substantial market opportunity for effective treatment alternatives [9]. - The acquisition is part of Vivos' broader strategy to create collaborations with key players in the sleep clinic sector, aiming to reach a larger patient volume and improve cash flow [7][9].

Financial Data and Key Metrics Changes - Total revenue for 2024 was $15 million, a 9% increase from $13.8 million in 2023, driven by higher product revenue from appliance sales, partially offset by a decrease in service revenue from fewer VIP enrollments [29][30] - Product revenue increased by 26% to approximately $7.9 million, with 16,182 oral appliance arches and guides sold, compared to 8,240 units for $6.3 million in 2023 [30] - Operating loss decreased by 35% to approximately $11.2 million in 2024 from $17.3 million in 2023, attributed to higher revenue and lower operating expenses [35] Business Line Data and Key Metrics Changes - The company successfully reduced operating expenses by 21%, leading to a significant reduction in operating loss [10] - Sales and marketing expenses decreased to approximately $1.7 million in 2024 from $2.5 million in 2023, reflecting lower sales commissions and expenses [32] - General and administrative expenses decreased by approximately $4.6 million, or 20%, to $17.9 million in 2024, driven by cost-cutting measures [33] Market Data and Key Metrics Changes - The company expanded into the Middle East, gaining regulatory approvals in key markets such as Dubai, Jordan, and Qatar, with demand exceeding forecasts [12] - The new marketing and distribution model aims to capture a significant share of the 125,000 newly diagnosed OSA patients per month in the U.S. [14] Company Strategy and Development Direction - The company is pivoting from a reliance on VIP enrollment revenue to a new model focusing on contractual profit-sharing alliances and acquisitions of sleep testing clinics [14][15] - The strategic alliance with Rebus Healthcare is expected to enhance the company's market presence and drive sales of its appliances [15][16] - The new model aims to present Vivos treatment options to more patients, increasing the likelihood of selecting Vivos over traditional CPAP treatments [20][21] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the future, expecting 2025 to be materially better in terms of top-line revenue and net profits compared to 2024 [70] - The company anticipates that the new marketing model will lead to higher revenue per case and increased profitability as it fully implements adjunctive diagnostic and therapeutic services [19][21] - Management highlighted the importance of training dentists and establishing partnerships with sleep centers to facilitate patient conversions [97][100] Other Important Information - The company raised approximately $17.9 million through equity transactions in 2024, strengthening its liquidity position [13][38] - As of December 31, 2024, the company had approximately $6.3 million in cash equivalents, up from $1.6 million in 2023 [38] Q&A Session Summary Question: What is the incentive for Rebus in the collaboration? - Management explained that Rebus sees an improvement in care quality and a new profit stream by offering Vivos treatments, differentiating themselves from competitors [44][49] Question: Can you elaborate on the transition of the medical integration division to an M&A team? - Management noted that the transition allows for direct engagement with medical sleep testing centers, enhancing the implementation of the new model [55][60] Question: How should investors view 2025 relative to 2024 in terms of revenue? - Management indicated that revenue from the Rebus affiliation will begin to show in 2025, with expectations for substantial growth throughout the year [70] Question: How does the $4,500 revenue from a patient work through the income statement? - Management clarified that this revenue will be categorized under product revenue, with adjustments to COGS for any profit-sharing arrangements [72][74] Question: What factors might affect the speed of converting potential customers into Vivos customers? - Management highlighted the importance of having trained dentists available and noted that they have a ready pool of interested providers [97][100] Question: What is the scale of potential acquisitions of sleep centers? - Management stated that sleep centers are typically profitable but operate on a high volume, low margin basis, indicating a strategic interest in acquiring such centers [114]

Company Performance - Vivos Therapeutics, Inc. reported a quarterly loss of $0.28 per share, which was better than the Zacks Consensus Estimate of a loss of $0.43, and a significant improvement from a loss of $3.05 per share a year ago, resulting in an earnings surprise of 34.88% [1] - The company posted revenues of $3.7 million for the quarter ended December 2024, missing the Zacks Consensus Estimate by 5.18%, but showing an increase from year-ago revenues of $3.25 million [2] - Over the last four quarters, Vivos Therapeutics has surpassed consensus EPS estimates two times, but has not been able to beat consensus revenue estimates during the same period [2] Stock Performance - Vivos Therapeutics shares have declined approximately 27.5% since the beginning of the year, compared to a decline of 5.1% for the S&P 500 [3] - The current consensus EPS estimate for the upcoming quarter is -$0.41 on revenues of $4.1 million, and for the current fiscal year, it is -$1.43 on revenues of $18.3 million [7] Industry Outlook - The Medical - Drugs industry, to which Vivos Therapeutics belongs, is currently ranked in the top 31% of over 250 Zacks industries, indicating a favorable outlook compared to the bottom 50% [8] - Empirical research suggests a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can impact Vivos Therapeutics' stock performance [5]

Revenue Performance - Product revenue increased by 26% year over year, contributing to a total revenue of approximately $15.0 million for the full year ended December 31, 2024, compared to $13.8 million in 2023[2] - Total revenue increased to $15,031 million in 2024, up from $13,801 million in 2023, representing a growth of 8.9%[18] - Product revenue rose to $7,874 million in 2024, compared to $6,270 million in 2023, reflecting an increase of 25.6%[18] - Service revenue decreased to $7,157 million in 2024, down from $7,531 million in 2023, indicating a decline of 5%[18] Operating Performance - Operating expenses decreased by $5.4 million, or 21%, to $20.2 million for the full year ended December 31, 2024, reflecting ongoing cost-cutting initiatives[2] - Total operating expenses decreased to $20,190 million in 2024, down from $25,567 million in 2023, a reduction of 21%[18] - Operating loss reduced by $6.1 million, or 35%, to $11.2 million in 2024 from $17.3 million in 2023[2] - Operating loss narrowed to $(11,171) million in 2024, compared to $(17,296) million in 2023, showing an improvement of 35%[18] Profitability and Loss - Net loss for 2024 was $(11,136) million, an improvement from $(13,583) million in 2023, reflecting a reduction of 18%[18] - Net loss per share (basic and diluted) improved to $(2.22) in 2024 from $(11.14) in 2023[18] Cash and Liquidity - Cash and cash equivalents increased to $6.3 million as of December 31, 2024, following approximately $17.9 million raised through four equity transactions during the year[2] - The company raised $7.5 million from New Seneca Partners as part of its efforts to strengthen capital structure and improve liquidity[4] - Vivos aims to achieve cash flow positive operations and profitability in the foreseeable future, supported by its new strategic initiatives[4] Patient Treatment and Market Strategy - The number of patients treated with Vivos' patented oral appliances rose to approximately 58,000 worldwide, up from over 42,000 at the end of 2023[2] - Vivos received FDA clearance for the DNA appliance in September 2024, allowing treatment of moderate to severe OSA in children ages 6 to 17, complementing the 2023 clearance for adults[2] - The new marketing and distribution strategy focuses on contractual, profit-sharing alliances with sleep healthcare providers, initiated with Rebis Health Holdings in June 2024[3] - Vivos expects to present treatments to more patients and increase revenue per case, projecting contribution margins of approximately 50% per patient[5] Shareholder Information - Weighted average number of shares outstanding increased significantly to 5,019,886 in 2024 from 1,219,381 in 2023[18] - The company reported a change in fair value of warrant liability, net of issuance costs, which contributed positively in 2023 but was not present in 2024[18]

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 ...