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Vivos Therapeutics Reports Third Quarter 2024 Financial Results and Provides Operational Update

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Vivos Therapeutics (NASDAQ: VVOS) reported strong Q3 2024 financial results with revenue increasing 17% to $3.9 million compared to Q3 2023. Gross profit reached $2.3 million with margins improving to 60%. Operating expenses decreased by 8%, marking the ninth consecutive quarter of year-over-year reductions. The company achieved significant milestones including FDA clearance for treating moderate to severe OSA in children ages 6-17 and new AMA CPT codes for their devices effective January 2024. Patient treatments increased to over 47,000 worldwide, with more than 2,000 trained dentists. The company projects achieving positive cash flow from operations by mid-2025.

Vivos Therapeutics (NASDAQ: VVOS) ha riportato risultati finanziari forti per il terzo trimestre del 2024, con un aumento del fatturato del 17% a 3,9 milioni di dollari rispetto al terzo trimestre del 2023. L'utile lordo ha raggiunto 2,3 milioni di dollari, con margini che sono migliorati al 60%. Le spese operative sono diminuite dell'8%, segnando il nono trimestre consecutivo di riduzioni anno su anno. L'azienda ha conseguito traguardi significativi, tra cui l'approvazione della FDA per il trattamento dell'OSA moderata a grave nei bambini di età compresa tra 6 e 17 anni e nuovi codici CPT AMA per i loro dispositivi, in vigore a gennaio 2024. I trattamenti per i pazienti sono aumentati a oltre 47.000 in tutto il mondo, con più di 2.000 dentisti formati. L'azienda prevede di raggiungere un cash flow positivo dalle operazioni entro metà del 2025.

Vivos Therapeutics (NASDAQ: VVOS) informó resultados financieros sólidos para el tercer trimestre de 2024, con un aumento del 17% en los ingresos, alcanzando 3,9 millones de dólares en comparación con el tercer trimestre de 2023. La ganancia bruta llegó a 2,3 millones de dólares, con márgenes mejorando al 60%. Los gastos operativos disminuyeron en un 8%, marcando el noveno trimestre consecutivo de reducciones interanuales. La empresa logró hitos significativos, incluyendo la autorización de la FDA para tratar la OSA moderada a severa en niños de 6 a 17 años y nuevos códigos CPT de la AMA para sus dispositivos, que entrarán en vigor en enero de 2024. Los tratamientos para pacientes aumentaron a más de 47,000 en todo el mundo, con más de 2,000 dentistas capacitados. La empresa prevé alcanzar flujo de efectivo positivo de las operaciones para mediados de 2025.

Vivos Therapeutics (NASDAQ: VVOS)는 2024년 3분기 강력한 재무 결과를 보고하며, 수익은 2023년 3분기 대비 17% 증가한 390만 달러에 달하고 있습니다. 총 이익은 230만 달러에 도달하며, 마진은 60%로 개선되었습니다. 운영 비용은 8% 감소하여, 전년 대비 연속적으로 아홉 번째 분기 감소를 기록했습니다. 회사는 6세에서 17세 아동의 중증도의 수면 무호흡증(OSA) 치료를 위한 FDA 허가 및 2024년 1월부터 시행되는 장치에 대한 새로운 AMA CPT 코드를 포함하여 중요한 이정표를 달성했습니다. 전 세계에서 환자 치료가 47,000건 이상 증가했으며, 2,000명 이상의 치과 의사가 교육을 받았습니다. 회사는 2025년 중반까지 운영에서 긍정적인 현금 흐름을 달성할 것으로 예상하고 있습니다.

Vivos Therapeutics (NASDAQ: VVOS) a annoncé de solides résultats financiers pour le troisième trimestre 2024, avec des revenus en hausse de 17% à 3,9 millions de dollars par rapport au troisième trimestre 2023. Le bénéfice brut a atteint 2,3 millions de dollars, avec des marges améliorées à 60%. Les dépenses d'exploitation ont diminué de 8%, marquant le neuvième trimestre consécutif de réductions d'une année sur l'autre. L'entreprise a atteint des jalons significatifs, notamment l'approbation par la FDA pour le traitement de l'OSA modéré à sévère chez les enfants âgés de 6 à 17 ans et de nouveaux codes CPT AMA pour leurs dispositifs, entrant en vigueur en janvier 2024. Les traitements des patients ont augmenté à plus de 47 000 dans le monde, avec plus de 2 000 dentistes formés. L'entreprise prévoit d'atteindre un flux de trésorerie positif provenant des opérations d'ici la mi-2025.

Vivos Therapeutics (NASDAQ: VVOS) berichtete von starken finanziellen Ergebnissen für das dritte Quartal 2024, mit einem Umsatzanstieg von 17% auf 3,9 Millionen Dollar im Vergleich zum dritten Quartal 2023. Der Bruttogewinn erreichte 2,3 Millionen Dollar, wobei sich die Gewinnmargen auf 60% verbesserten. Die Betriebskosten sanken um 8%, was das neunte aufeinanderfolgende Quartal mit einem Rückgang im Jahresvergleich markiert. Das Unternehmen erreichte bedeutende Meilensteine, darunter die FDA-Zulassung zur Behandlung von moderater bis schwerer OSA bei Kindern im Alter von 6 bis 17 Jahren sowie neue AMA CPT-Codes für ihre Geräte, die ab Januar 2024 in Kraft treten. Die Patientenbehandlungen stiegen auf über 47.000 weltweit, mit mehr als 2.000 ausgebildeten Zahnärzten. Das Unternehmen plant, bis Mitte 2025 einen positiven Cashflow aus den Betrieben zu erzielen.

Positive
  • Revenue increased 17% to $3.9 million in Q3 2024
  • Gross margin improved to 60% from 53% year-over-year
  • Operating expenses decreased 8% versus Q3 2023
  • Operating loss reduced by 27% year-over-year
  • Secured $4.3 million through equity offering
  • Obtained FDA clearance for pediatric OSA treatment
  • Received new AMA CPT medical codes for devices
Negative
  • Still operating at a loss
  • Positive cash flow not expected until mid-2025
  • Lower myofunctional therapy revenues reported

Insights

The Q3 2024 results show encouraging signs of operational improvement. $3.9 million revenue represents a 17% YoY growth, while the 27% reduction in operating loss demonstrates effective cost management. Key financial highlights include:

  • Improved gross margin at 60% vs 53% in Q3 2023
  • Ninth consecutive quarter of reduced operating expenses
  • Strong cash position of $6.3 million following $4.3 million equity offering

The FDA clearance for pediatric OSA treatment and new AMA CPT codes effective January 2024 create significant revenue growth opportunities. However, the $13.8 million market cap suggests investors remain cautious about the path to profitability, despite management's projection of positive cash flow by mid-2025.

The expansion from 40,000 to 47,000 patients treated worldwide demonstrates growing clinical adoption of Vivos' technology. The FDA clearance for treating moderate to severe OSA in children ages 6-17 is particularly significant, as it opens an underserved market with treatment options. The company's strategic pivot toward medical sleep specialists and healthcare practitioner collaborations could accelerate market penetration. The increase in trained dentists from 1,850 to 2,000 indicates sustained professional interest in the treatment protocol.

Revenue Increased 17% Quarter over Quarter

Operating Loss Decreased 27%

Management to Host Conference Call Today at 5:00 pm ET

LITTLETON, Colo., Nov. 14, 2024 (GLOBE NEWSWIRE) -- Vivos Therapeutics, Inc. (“Vivos” or the “Company”) (NASDAQ: VVOS), a leading medical device and technology company specializing in the development and commercialization of highly effective proprietary treatments for sleep-related breathing disorders (including all severities of obstructive sleep apnea (OSA) and snoring in adults and moderate to severe OSA in children ages 6 – 17), today reported financial results and operating highlights for the third quarter and nine months ended September 30, 2024.

Third Quarter 2024 Financial and Operating Summary

  • Revenue was $3.9 million for the third quarter of 2024 and $11.3 million for the nine months ended September 30, 2024, compared to $3.3 million and $10.6 million for the three and nine months ended September 30, 2023, respectively, mainly due to increased revenue from higher product sales and lower discounts of Vivos appliances coupled with higher service revenue primarily from early recognition of deferred enrollment revenue, sponsorships and seminars, offset by lower myofunctional therapy revenues.
  • Gross profit was $2.3 million for the third quarter of 2024 and $6.9 million for the nine months ended September 30, 2024, compared to $1.7 million and $6.2 million for the comparable periods in 2023, primarily attributable to the increase in revenue.
  • Gross margin increased to 60% for the third quarter of 2024, compared to 53% for the third quarter of 2023 due primarily to the revenue increase. Gross margin for the nine months ended September 30, 2024 was 61%, compared with 59% during the same period in 2023.
  • Operating expenses for the third quarter of 2024 decreased by $0.4 million, or 8% versus the third quarter of 2023, reflecting the success of Vivos’ continuing cost-cutting initiatives, resulting in the ninth consecutive quarter of year over year reductions in operating expenditures. For the nine months ended September 30, 2024 operating expenses decreased by $4.1 million or 21%, compared to the same period in 2023.
  • Vivos’ cost-cutting initiatives also led to a $1 million or 27% year-over-year reduction in operating loss, versus the third quarter of 2023. For the nine months ended September 30, 2024 operating loss decreased by $4.8 million or 36%, compared to the same period in 2023. Vivos anticipates attaining positive cash flow from operations by mid-2025.
  • In September, Vivos announced the closing of a $4.3 million registered direct equity offering, improving cash on hand, working capital and stockholders’ equity. As of September 30, 2024, cash and cash equivalents were $6.3 million while stockholders’ equity was $7.7 million.
  • As of September 30, 2024, patients treated with Vivos’ patented oral appliances totaled over 47,000 worldwide, compared to over 40,000 as of September 30, 2023. Vivos has also trained more than 2,000 dentists in the use of The Vivos Method and Vivos’ related value-added services, compared to approximately 1,850 as of September 30, 2023.
  • In September, Vivos announced receipt of the first ever U.S. Food and Drug Administration (FDA) 510(k) clearance to treat moderate to severe OSA and snoring in children ages 6 to 17 using Vivos’ proprietary flagship oral medical device. This milestone creates the potential to address this important market and increase revenue.
  • In October 2024, the American Medical Association (AMA) issued new CPT® medical codes applicable to all Vivos CARE oral medical devices, which will become effective January 1, 2024. This achievement creates the potential for wider adoption of Vivos devices and the resulting potential for increased revenue.

Kirk Huntsman, Vivos’ Chairman and Chief Executive Officer, stated, “Today, we reported a 17% increase in third-quarter topline revenue as we leverage our proprietary technology and treatment protocols, which offer highly effective treatment alternatives for OSA patients. Our third-quarter results mark the ninth consecutive quarter of year-over-year decreases in operating expenses as we continue to focus on costs as we seek to grow revenue. During the quarter and more recently, we also achieved important milestones to strengthen the foundation for future growth, notably a key FDA clearance for use of our devices in children and the issuance of new insurance codes covering our devices.”

“Our new marketing and distribution model announced in June, which leverages contractual alliances with medical sleep specialists, continues to show promise in its early stages. As we previously anticipated, revenues from this new model were not material in the third quarter, although we have seen enough to date to warrant expanding the program to two additional locations in Colorado, which we expect to have operational by the end of 2024 or very early in 2025. We are also in discussions to expand the model through similar alliances with other medical sleep providers, and we expect to continue to refine the model as it rolls out based on our experiences. As we continue to move more directly and vertically into affiliations and collaborations with medical specialists, functional medicine doctors, and other sleep-related healthcare practitioners, we expect this to positively impact our new case starts, revenue growth and gross profit in 2025”, Mr. Huntsman concluded.

Vivos encourages investors and other interested parties to join its conference call today at 5:00 p.m. Eastern time (details below), where management will further discuss the financial and operating results of the third quarter of 2024.

In addition, further information on Vivos’ financial results is included in the attached unaudited condensed consolidated balance sheets and statements of operations. Additional explanations of Vivos’ financial performance are provided in the Vivos’ Quarterly Report on Form 10-Q for the three and nine months ended September 30, 2024, which will be filed with the Securities and Exchange Commission (“SEC”). The full 10-Q report will be available on the SEC Filings section of the Investor Relations section of Vivos’ website at https://vivos.com/investor-relations.

Conference Call

To access Vivos’ investor conference call, please dial (800) 717-1738 or (646) 307-1865 for international callers. Participants can use the Guest dial-in numbers above and be answered by an operator, or they can click the Call me™ link https://emportal.ink/3NzntGx for instant telephone access to the event. Call me™ link will be made active 15 minutes prior to the scheduled start time. A replay will be available shortly after the call and can be accessed by dialing (844) 512-2921 or (412) 317-6671 for international callers. The passcode for the replay is 1196680. The replay will be available until November 29, 2024.

The live conference call webcast can be accessed on Vivos’ website at https://vivos.com/investor-relations. The company will also post an online archive of the webcast on its website for 30 days after the call.

About Vivos Therapeutics, Inc.
Vivos Therapeutics, Inc. (NASDAQ: VVOS) is a medical technology company focused on developing and commercializing innovative diagnostic and treatment methods for patients suffering from breathing and sleep issues arising from certain dentofacial abnormalities such as obstructive sleep apnea (OSA) and snoring in adults and children. The Vivos Method represents the first clinically effective nonsurgical, noninvasive, nonpharmaceutical, and cost-effective solution for treating mild to severe OSA in adults and moderate to severe OSA in children. It has proven effective in over 47,000 patients treated worldwide by more than 2,000 trained dentists.

The Vivos Method includes treatment regimens that employ proprietary CARE appliance therapy and other modalities that alter the size, shape, and position of the jaw and soft tissues that comprise a patient’s upper airway and/or palate. The Vivos Method opens airway space and may significantly reduce symptoms and conditions associated with mild-to-severe OSA in adults and moderate-to-severe OSA in children ages 6 to 17, such as lowering Apnea Hypopnea Index scores. Vivos also markets and distributes SleepImage diagnostic technology under its VivoScore program for home sleep testing in adults and children. The Vivos Integrated Practice (VIP) program offers dentists training and other value-added services in connection with using The Vivos Method. Vivos also employs a marketing and distribution model where it collaborates with sleep-treatment providers to offer patients OSA treatment options and help promote sales of its appliances.

For more information, visit www.vivos.com.

Cautionary Note Regarding Forward-Looking Statements

This press release, the conference call referred to herein, and statements of the Company’s management made in connection therewith contain “forward-looking statements” (as defined in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended) concerning future events. Words such as “may”, “should”, “expects”, “projects,” “intends”, “plans”, “believes”, “anticipates”, “hopes”, “estimates”, “goal” and variations of such words and similar expressions are intended to identify forward-looking statements. These statements involve significant known and unknown risks and are based upon several assumptions and estimates, which are inherently subject to significant uncertainties and contingencies, many of which are beyond Vivos’ control. Actual results (including the actual future impact of the initiatives and corporate achievements described herein on Vivos’ future revenues and results of operations and the anticipated benefits of the Company’s new marketing and distribution model described herein) may differ materially and adversely from those expressed or implied by such forward-looking statements. Factors that could cause actual results to differ materially include, but are not limited to: (i) the risk that Vivos may be unable to implement revenue, sales and marketing strategies that increase revenues, (ii) the risk that some patients may not achieve the desired results from using Vivos’ products, (iii) risks associated with regulatory scrutiny of and adverse publicity in the sleep apnea treatment sector; (iv) the risk that Vivos may be unable to secure additional financings on reasonable terms when needed, if at all or maintain its Nasdaq listing and (v) other risk factors described in Vivos’ filings with the Securities and Exchange Commission (“SEC”). Vivos’ filings can be obtained free of charge on the SEC’s website at www.sec.gov. Except to the extent required by law, Vivos expressly disclaims any obligations or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Vivos’ expectations with respect thereto or any change in events, conditions, or circumstances on which any statement is based.

Vivos Investor Relations and Media Contact:
Bradford Amman, CFO
investors@vivoslife.com

-Tables Follow-

 
VIVOS THERAPEUTICS INC.
Unaudited Condensed Consolidated Balance Sheets
(In Thousands, Except Per Share Amounts)
 
  September 30, 2024  December 31, 2023 
       
Current assets        
Cash and cash equivalents $6,311  $1,643 
Accounts receivable, net of allowance of $262 and $250, respectively  454   202 
Prepaid expenses and other current assets  634   616 
         
Total current assets  7,399   2,461 
         
Long-term assets        
Goodwill  2,843   2,843 
Property and equipment, net  3,317   3,314 
Operating lease right-of-use asset  1,129   1,385 
Intangible assets, net  383   420 
Deposits and other  276   307 
         
Total assets $15,347  $10,730 
         
LIABILITIES AND STOCKHOLDERS’ EQUITY        
Current liabilities        
Accounts payable $1,075  $2,145 
Accrued expenses  2,054   2,334 
Current portion of contract liabilities  1,313   2,138 
Current portion of operating lease liability  485   474 
Other current liabilities  199   198 
         
Total current liabilities  5,126   7,289 
         
Long-term liabilities        
Contract liabilities, net of current portion  178   289 
Employee retention credit liability  1,220   1,220 
Operating lease liability, net of current portion  1,158   1,521 
         
Total liabilities  7,682   10,319 
         
Commitments and contingencies   --     --  
         
Stockholders’ equity        
Preferred Stock, $0.0001 par value per share. Authorized 50,000,000 shares; no shares issued and outstanding  -   - 
Common Stock, $0.0001 par value per share. Authorized 200,000,000 shares; issued and outstanding 4,765,300 shares as of September 30, 2024 and 1,833,877 shares as December 31, 2023  -   - 
Additional paid-in capital  109,025   93,462 
Accumulated deficit  (101,360)  (93,051)
Total stockholders’ equity  7,665   411 
Total liabilities and stockholders’ equity $15,347  $10,730 


VIVOS THERAPEUTICS INC.
Unaudited Condensed Consolidated Statements of Operations
(In Thousands, Except Per Share Amounts)
 
  Three Months Ended
September 30,
  Nine Months Ended
September 30,
 
  2024  2023  2024  2023 
Revenue                
Product revenue $1,958  $1,466  $5,608  $4,783 
Service revenue  1,902   1,835   5,725   5,770 
Total revenue  3,860   3,301   11,333   10,553 
                 
Cost of sales (exclusive of depreciation and amortization shown separately below)  1,526   1,554   4,411   4,371 
                 
Gross profit  2,334   1,747   6,922   6,182 
                 
Operating expenses                
General and administrative  4,487   4,596   13,531   17,012 
Sales and marketing  346   641   1,319   1,861 
Depreciation and amortization  146   150   437   472 
                 
Total operating expenses  4,979   5,387   15,287   19,345 
                 
Operating loss  (2,645)  (3,640)  (8,365)  (13,163)
                 
Non-operating income (expense)                
Other expense  (18)  (53)  (42)  (198)
Excess warrant fair value  -   -   -   (6,453)
Change in fair value of warrant liability, net of issuance costs of $645  -   1,600   -   10,362 
Other income  47   -   98   128 
Loss before income taxes  (2,616)  (2,093)  (8,309)  (9,324)
                 
Net loss $(2,616) $(2,093) $(8,309) $(9,324)
                 
Net loss per share (basic and diluted) $(0.40) $(1.75) $(1.94) $(8.09)
Weighted average number of shares of Common Stock outstanding (basic and diluted)  6,615,320   1,197,258   4,282,210   1,152,607 

FAQ

What was Vivos Therapeutics (VVOS) revenue in Q3 2024?

Vivos Therapeutics reported revenue of $3.9 million in Q3 2024, representing a 17% increase compared to Q3 2023.

When does Vivos Therapeutics (VVOS) expect to achieve positive cash flow?

Vivos Therapeutics anticipates achieving positive cash flow from operations by mid-2025.

What was the significant FDA clearance received by Vivos (VVOS) in September 2024?

Vivos received FDA 510(k) clearance to treat moderate to severe OSA and snoring in children ages 6 to 17 using their proprietary flagship oral medical device.

How many patients have been treated with Vivos (VVOS) oral appliances as of Q3 2024?

As of September 30, 2024, over 47,000 patients worldwide have been treated with Vivos' patented oral appliances.

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