0001493152-23-020595.txt : 20230608 0001493152-23-020595.hdr.sgml : 20230608 20230608170038 ACCESSION NUMBER: 0001493152-23-020595 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 13 CONFORMED PERIOD OF REPORT: 20230608 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20230608 DATE AS OF CHANGE: 20230608 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Vivos Therapeutics, Inc. CENTRAL INDEX KEY: 0001716166 STANDARD INDUSTRIAL CLASSIFICATION: SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841] IRS NUMBER: 813224056 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-39796 FILM NUMBER: 231002739 BUSINESS ADDRESS: STREET 1: 7921 SOUTHPARK PLAZA, STREET 2: SUITE 210 CITY: LITTLETON STATE: CO ZIP: 80120 BUSINESS PHONE: (866)908-4867 MAIL ADDRESS: STREET 1: 7921 SOUTHPARK PLAZA, STREET 2: SUITE 210 CITY: LITTLETON STATE: CO ZIP: 80120 FORMER COMPANY: FORMER CONFORMED NAME: Vivos BioTechnologies, Inc. DATE OF NAME CHANGE: 20170901 8-K 1 form8-k.htm
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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

 

Pursuant to Section 13 OR 15(d) of the

Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported): June 8, 2023

 

Vivos Therapeutics, Inc.

(Exact name of registrant as specified in its charter)

 

Delaware   001-39796   81-3224056
(State or other jurisdiction   (Commission   (I.R.S. Employer
of incorporation)   File Number)   Identification No.)

 

7921 Southpark Plaza, Suite 210

Littleton, Colorado 80120

(Address of principal executive offices) (Zip Code)

 

(866) 908-4867

(Registrant’s telephone number, including area code)

 

N/A

(Former name or former address, if changed since last report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
   
☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
   
☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
   
☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class   Trading Symbol(s)   Name of each exchange on which registered
Common Stock, par value $0.0001 per share   VVOS   The NASDAQ Stock Market LLC

 

Indicate by check mark whether the registrant is an emerging growth company as defined in as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

Emerging growth company ☒

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

 

 

 

 

 

Item 2.02. Results of Operations and Financial Condition.

 

On June 8, 2023, Vivos Therapeutics, Inc. (the “Company”) issued a press release announcing its financial results for the first quarter ended March 31, 2023. The full text of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

 

The information in this Current Report on Form 8-K (including Exhibit 99.1) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, nor shall it be deemed to be incorporated by reference into any filing of the Company under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.

 

Item 9.01. Financial Statements and Exhibits.

 

(d) Exhibits

 

Exhibit No.   Description
99.1   Press Release of the Company, dated June 8, 2023, announcing its financial results for the first quarter ended March 31, 2023.
104   Cover Page Interactive Data File (embedded within the Inline XBRL document). 

 

 

 

 

SIGNATURE

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

  VIVOS THERAPEUTICS, INC.
     
Dated: June 8, 2023 By: /s/ Bradford Amman
  Name: Bradford Amman
  Title: Chief Financial Officer

 

 

 EX-99.1 2 ex99-1.htm

 

Exhibit 99.1

 

Vivos Therapeutics Reports First Quarter 2023 Financial Results and Provides Operational Update

 

Revenue increased 6% Year-Over-Year; Operating Expenses Decreased 20%
as Cost Cutting Initiatives Take Hold

 

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

 

LITTLETON, Colo., June 8, 2023 – Vivos Therapeutics, Inc. (“Vivos” or the “Company’’) (NASDAQ: VVOS), a medical technology company focused on developing and commercializing innovative diagnostic and treatment methods for patients suffering from a variety of health conditions, many of which are associated with breathing related sleep issues arising from certain dentofacial abnormalities, today reported financial results and operating highlights for the first quarter ended March 31, 2023.

 

First Quarter 2023 Financial Highlights

 

  ● Revenue was $3.9 million for the first quarter of 2023, compared to $3.6 million for the first quarter of 2022, mainly due to higher Vivos Integrated Provider (“VIP”) enrollments as well as increased revenue from seminars conducted at the Vivos Institute (readers should note that Vivos’ reported financial results for the three months ended March 31, 2023 and 2022 reflect the application of Vivos’ previously announced updated ASC 606 revenue recognition policies, including deferral of a portion of revenue into future periods);
     
  ● During the first quarter of 2023, Vivos enrolled 38 VIPs and recognized VIP revenue of approximately $1.3 million, an increase of 42% in enrollment revenue, compared to 32 VIPs and approximately $0.9 million for the first quarter of 2022;
     
  ● Gross profit was $2.3 million for the first quarter of 2023, compared to gross profit of $2.6 million for the first quarter of 2022, attributable to higher costs associated with increased VIP training as well as the sale and leasing of SleepImage® home sleep test rings;
     
  ● Gross margin was 61% for the first quarter of 2023, compared to 70% for the first quarter of 2022, reflecting higher costs associated with VIP training and new incentives deployed to increase VIP enrollments;
     
  ● Operating expenses decreased by a significant amount ($1.8 million, or 20%) versus the first quarter of 2022, reflecting Vivos’ previously announced cost-cutting initiatives. These initiatives, when combined with a $3.2 million non-cash derivative gain associated with Vivos’ outstanding warrants, led to a significant year-over-year reduction of net loss for the quarter;
     
  ● In January 2023, Vivos completed a private placement for net proceeds of approximately $7.4 million to augment its liquidity position; and
     
  ● Cash and cash equivalents were $7.0 million at March 31, 2023.

 

 

 

 

First Quarter 2023 and Recent Operating Highlights

 

  ● As of March 31 2023, patients treated with The Vivos Method totaled over 35,000, compared to approximately 28,000 as of the first quarter of 2022. Vivos has also trained over 1,750 dentists in the use of The Vivos Method and Vivos’ related value-added services, compared to more than 1,600 as of the first quarter 2022;
     
  ●

In February 2023, Vivos acquired certain U.S. and international patents, product rights, and other miscellaneous intellectual property from Advanced Facialdontics, LLC (“AFD”), a company holding propriety technology with FDA 510(k) clearances for Temporomandibular Joint Dysfunction (“TMD”) and Bruxism (unconscious teeth grinding and clenching). With this asset purchase transaction, Vivos acquired recently issued U.S. patents, provisional patent applications as well as international patents, Patent Cooperation Treaty patents and patent applications. One of Vivos’ key strategic goals for the remainder of 2023 is to initiate and grow sales of the AFD products, notably the Preventive Oral Device® (known as The POD®); and

     
  ● In May 2023, Vivos announced the results of a clinical observational study on the application of the POD® in the treatment and prevention of migraine headaches. The study demonstrated statistically significant results, with ninety-two percent (92%) of study patients reporting their migraine symptoms were completely resolved following completion of treatment. Migraine headaches affect over 39 million people in the United States alone according to the American Migraine Foundation.

 

“Vivos is evolving into a more scalable and sustainable growth company with a clear path to cash flow positive operations. By broadening and diversifying our core product offerings and giving potential new providers easier and less costly options to enroll and become Vivos-trained, we believe we are positioning ourselves to become the comprehensive go-to source for dental treatments for OSA and other debilitating conditions like TMD and Bruxism. No other company in our market has the evidence-based technologies, or the regulatory clearances, or the clinical and technical expertise, or the full complementary product line, or the strong brand equity that Vivos has with healthcare providers and patients,” stated Kirk Huntsman, Vivos’ Chairman and Chief Executive Officer. “We continue to believe our latest rounds of cost cutting, the impact of which can be seen in our first quarter results, coupled with an intense focus on creating accretive new revenue streams, will allow us to achieve our stated goal of achieving positive cash flow in the first quarter of 2024.”

 

“During the first quarter, we continued to make substantial progress towards realizing our potential. Our focused sales and marketing efforts are gaining traction and our organizational changes have made Vivos a more efficient, streamlined organization. With our expanded products and services offering, we are well positioned to continue attracting more dentists and medical professionals to utilize the Vivos Method, as well as larger organizations, including Durable Medical Equipment (known as DME) companies and Dental Service Organizations (known as DSOs), to market and distribute our products. As we seek to drive revenue growth, Vivos now has new or active pilot programs with eight different DSO organizations, representing over 1,000 dental practices, as well as a new pilot program we will be launching shortly with a nationally regarded DME to distribute our devices. We are pleased with what we have achieved so far in 2023, and look forward to continuing this momentum during the rest of the year and into 2024,” 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 discuss further details on topics including: (i) the acquisition of product rights and patents from AFD and Vivos’ expanded product line and revenue potential, (ii) the potential significant impact of Vivos’ recent discussions with DME companies on Vivos’ near-term growth, (iii) an update on Vivos’ DSO and DME sales and marketing efforts; (iv) additional programs for dentists to enroll with Vivos, and (v) Vivos’ current cash position and actions taken to reduce cash burn.

 

In addition, further information on Vivos’ financial results is included on the attached condensed consolidated balance sheets and statements of operations, and additional explanations of Vivos’ financial performance are provided in the Vivos’ Quarterly Report on Form 10-Q for the three months ended March 31, 2023, 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 (877) 451-6152, or for international callers, (201) 389-0879. A replay will be available shortly after the call and can be accessed by dialing (844) 512-2921, or for international callers, (412) 317-6671. The passcode for the live call and the replay is 13739119. The replay will be available until June 22, 2023.

 

A live webcast of the conference call can be accessed on Vivos’ website at https://vivos.com/investor-relations. An online archive of the webcast will be available on the Company’s website for 30 days following 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 mild-to-moderate obstructive sleep apnea (OSA) and snoring in adults. The Vivos Method represents the first clinically effective nonsurgical, noninvasive, nonpharmaceutical and cost-effective solution for treating mild to moderate OSA. It has proven effective in over 35,000 patients treated worldwide by more than 1,750 trained dentists.

 

The Vivos Method includes the Vivos Complete Airway Repositioning and/or Expansion (CARE) appliance therapy and associated protocols that alter the size, shape and position of the 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-moderate OSA, 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.

 

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, particularly with respect to the public offering described herein. 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, without limitation, the results of Vivos’ sales, marketing and cost cutting initiatives as described herein) may differ materially 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 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 Contact:

Julie Gannon

Investor Relations Officer

720-442-8113

jgannon@vivoslife.com

 

-Tables Follow-

 

 

 

 

VIVOS THERAPEUTICS INC.

Unaudited Condensed Consolidated Balance Sheets

(In Thousands, Except Per Share Amounts)

 

  

March 31,

2023

  

December 31,

2022

 
         
Current assets          
Cash and cash equivalents  $7,046   $3,519 
Accounts receivable, net of allowance of $672 and $712, respectively   321    457 
Prepaid expenses and other current assets   1,346    1,448 
           
Total current assets   8,713    5,424 
           
Long-term assets          
Goodwill   2,843    2,843 
Property and equipment, net   3,157    3,082 
Operating lease right-of-use asset   1,621    1,695 
Intangible assets, net   458    302 
Deposits and other   308    374 
           
Total assets  $17,100   $13,720 
           
LIABILITIES AND STOCKHOLDERS’ EQUITY          
Current liabilities          
Accounts payable  $1,495   $1,411 
Accrued expenses   1,940    1,912 
Warrant liability   1,333    - 
Current portion of contract liabilities   2,647    2,926 
Current portion of operating lease liability   433    419 
Other current liabilities   127    145 
           
Total current liabilities   7,975    6,813 
           
Long-term liabilities          
Contract liabilities, net of current portion   250    112 
Operating lease liability, net of current portion   1,882    1,994 
           
Total liabilities   10,107    8,919 
           
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 29,928,786 shares as of March 31, 2023 and 23,012,119 shares as December 31, 2022   3    2 
Additional paid-in capital   88,161    84,267 
Accumulated deficit   (81,171)   (79,468)
Total stockholders’ equity   6,993    4,801 
Total liabilities and stockholders’ equity  $17,100   $13,720 

 

 

 

 

VIVOS THERAPEUTICS INC.

Unaudited Condensed Consolidated Statements of Operations

(In Thousands, Except Per Share Amounts)

 

   Three Months Ended March 31, 
   2023   2022 
Revenue          
Product revenue  $1,772   $2,049 
Service revenue   2,085    1,595 
Total revenue   3,857    3,644 
           
Cost of sales (exclusive of depreciation and amortization shown separately below)   1,520    1,093 
           
Gross profit   2,337    2,551 
           
Operating expenses          
General and administrative   6,537    8,275 
Sales and marketing   630    753 
Depreciation and amortization   175    162 
           
Total operating expenses   7,342    9,190 
           
Operating loss   (5,005)   (6,639)
           
Non-operating income (expense)          
Other expense   51    (38)
PPP loan forgiveness   -    1,287 
Excess warrant fair value   (6,453)     
Change in fair value of warrant liability, net of issuance costs of $645   9,628    - 
Other income   76    59 
           
Net loss  $(1,703)  $(5,331)
           
Net loss per share (basic and diluted)  $(0.07)  $(0.25)
           
Weighted average number of shares of Common Stock outstanding (basic and diluted)   24,764,041    21,233,485 

 

 

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