UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-Q
(Mark
One)
☒
QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the quarterly period ended March 31, 2022
OR
☐
TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the Transition Period from
to
Commission
File Number: 001-39796
Vivos
Therapeutics, Inc.
(Exact
Name of Registrant as Specified in its Charter)
Delaware
81-3224056
(State
or other jurisdiction
of incorporation or organization)
(I.R.S.
Employer
Identification No.)
9137
Ridgeline Boulevard , Suite 135 ,
Highlands Ranch , CO
80129
(Address
of principal executive offices)
(Zip
Code)
Registrant’s
telephone number, including area code:
(844)
672-4357
Securities
registered pursuant to Section 12(b) of the Act:
Title
of each class
Trading
symbol(s)
Name
of exchange on which registered
Common
stock, par value $0.0001 per share
VVOS
Nasdaq
Capital Market
Indicate
by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange
Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2)
has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐
Indicate
by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule
405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant
was required to submit such files). Yes ☒ No ☐
Indicate
by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting
company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,”
“smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large
accelerated filer ☐
Accelerated
filer ☐
Non-accelerated
filer ☒
Smaller
reporting company ☒
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. ☐
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒
As
of May 16, 2022, the registrant had 23,012,119 shares of common stock, $0.0001 par value per share, outstanding.
TABLE
OF CONTENTS
Page
Cautionary Note Regarding Forward-Looking Statements
3
PART
I.
FINANCIAL INFORMATION
4
Item
1.
Consolidated Financial Statements (Unaudited)
4
Balance Sheets as of March 31, 2022 and December 31, 2021
4
Statements of Operations for the three months ended March 31, 2022 and 2021
5
Statements of Stockholder’s Equity as of March 31, 2022 and 2021
6
Statements of Cash Flows for the three months ended March 31, 2022 and 2021
7
Notes to Consolidated Financial Statements
8
Item
2.
Management’s Discussion and Analysis of Financial Condition and Results of Operations
26
Item
3.
Quantitative and Qualitative Disclosures About Market Risk
33
Item
4.
Controls and Procedures
33
PART
II.
OTHER INFORMATION
34
Item
1.
Legal Proceedings
34
Item
1A.
Risk Factors
35
Item
2.
Unregistered Sales of Equity Securities and Use of Proceeds
35
Item
3.
Defaults Upon Senior Securities
35
Item
4.
Mine Safety Disclosures
35
Item
5.
Other Information
35
Item
6.
Exhibits, Financial Statement Schedules
36
Signatures
37
2
CAUTIONARY
NOTE REGARDING FORWARD-LOOKING STATEMENTS
This
Quarterly Report on Form 10-Q contains forward-looking statements that reflect our current expectations and views of future events. The
forward-looking statements are contained principally in the sections entitled “Risk Factors” and “Management’s
Discussion and Analysis of Financial Condition and Results of Operations.” Readers are cautioned that known and unknown risks,
uncertainties and other factors, including those over which we may have no control and others listed in the “Risk Factors”
section of this Quarterly Report on Form 10-Q, may cause our actual results, performance or achievements to be materially different from
those expressed or implied by the forward-looking statements.
You
can identify some of these forward-looking statements by words or phrases such as “may,” “will,” “expect,”
“anticipate,” “aim,” “estimate,” “intend,” “plan,” “believe,”
“is/are likely to,” “potential,” “continue” or other similar expressions. We have based these forward-looking
statements largely on our current expectations and projections about future events that we believe may affect our financial condition,
results of operations, business strategy and financial needs.
These
forward-looking statements include statements relating to:
●
our
ability to continue to refine and execute our business plan, including the recruitment of dentists to enroll in our Vivos Integrated
Practice (VIP) program and utilize The Vivos Method;
●
the
understanding and adoption by dentists and other healthcare professionals of The Vivos Method as a treatment for dentofacial abnormalities
and/or mild to moderate obstructive sleep apnea (OSA) and snoring in adults;
●
our
expectations concerning the effectiveness of treatment using The Vivos Method and patient relapse after completion of treatment;
●
the
potential financial benefits to VIP dentists from treating patients with The Vivos Method;
●
our
potential profit margin from the enrollment of VIPs, VIP service fees, sales of The Vivos Method treatments and appliances and leases
of SleepImage home sleep testing rings as part of the VivoScore Program;
●
our
ability to properly train VIPs in the use of The Vivos Method inclusive of the services we offer independent dentist for use in treating
their patients in their dental practices;
●
our
ability to formulate, implement and modify as necessary effective sales, marketing and strategic initiatives to drive revenue growth
(including, for example, our Medical Integration Division and SleepImage ® home sleep apnea test);
●
the
viability of our current intellectual property and intellectual property created in the future;
●
acceptance
by the marketplace of the products and services that we market;
●
government
regulations and our ability to obtain applicable regulatory approvals and comply with government regulations including under healthcare
laws and the rules and regulations of the U.S. Food and Drug Administration;
●
our
ability to retain key employees;
●
adverse
changes in general market conditions for medical devices and the products and services we offer;
●
our
ability to generate cash flow and profitability and continue as a going concern;
●
our
future financing plans; and
●
our
ability to adapt to changes in market conditions (including as a result of the COVID-19 pandemic) which could impair our operations
and financial performance.
These
forward-looking statements involve numerous risks and uncertainties. Although we believe that our expectations expressed in these forward-looking
statements are reasonable, our expectations may later be found to be incorrect. Our actual results of operations or the results of other
matters that we anticipate herein could be materially different from our expectations. Important risks and factors that could cause our
actual results to be materially different from our expectations are generally set forth in “Risk Factors,” “Management’s
Discussion and Analysis of Financial Condition and Results of Operations,” “Business,” “Regulation” and
other sections in this Quarterly Report on Form 10-Q. You should thoroughly read this Quarterly Report on Form 10-Q and the documents
that we refer to with the understanding that our actual future results may be materially different from and worse than what we expect.
We qualify all of our forward-looking statements by these cautionary statements.
The
forward-looking statements made in this Quarterly Report on Form 10-Q relate only to events or information as of the date on which the
statements are made in this Quarterly Report on Form 10-Q. Except as required by law, we undertake no obligation to update or revise
publicly any forward-looking statements, whether as a result of new information, future events or otherwise, after the date on which
the statements are made or to reflect the occurrence of unanticipated events. You should read this Quarterly Report on Form 10-Q and
the documents that we refer to in this Quarterly Report on Form 10-Q and have filed as exhibits to this Quarterly Report on Form 10-Q,
completely and with the understanding that our actual future results may be materially different from what we expect.
3
PART
I – FINANCIAL INFORMATION
Item
1. Financial Statements.
VIVOS
THERAPEUTICS INC.
Unaudited
Consolidated Balance Sheets
(In
Thousands, Except Per Share Amounts)
March 31, 2022
December 31, 2021
ASSETS
Current assets
Cash and cash equivalents
$ 17,828
$ 24,030
Accounts receivable, net of allowance of $ 181 and $ 180 , respectively
1,002
1,203
Tenant improvement allowance receivable
516
516
Prepaid expenses and other current assets
2,255
1,575
Total current assets
21,601
27,324
Long-term assets
Goodwill
2,843
2,843
Property and equipment, net
2,913
2,825
Operating lease right-of-use asset
1,514
-
Intangible assets, net
331
341
Deposits and other
354
356
Total assets
$ 29,556
$ 33,689
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities
Accounts payable
$ 877
$ 920
Accrued expenses
3,172
2,853
Contract liabilities
2,344
2,399
Current portion of long-term debt
-
1,265
Current portion of operating lease liability
357
72
Other current liabilities
101
-
Total current liabilities
6,851
7,509
Long-term liabilities
Operating lease liability, net of current portion
1,850
641
Total liabilities
8,701
8,150
Commitments and contingencies (Note 13)
-
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 23,012,119 shares as of March 31, 2022 and December 31, 2021
2
2
Additional paid-in capital
81,991
81,160
Accumulated deficit
( 61,138 )
( 55,623 )
Total stockholders’ deficit Total stockholders’ equity
20,855
25,539
Total liabilities and stockholders’ deficit Total liabilities and stockholders’ equity
$ 29,556
$ 33,689
The
accompanying notes are an integral part of these unaudited consolidated financial statements.
4
VIVOS
THERAPEUTICS INC.
Unaudited
Consolidated Statements of Operations
(In
Thousands, Except Per Share Amounts)
2022
2021
Three Months Ended March 31,
2022
2021
Revenue
Product revenue
$ 1,722
$ 1,387
Service revenue
1,738
2,061
Total revenue
3,460
3,448
Cost of sales (exclusive of depreciation and amortization shown separately below)
1,093
758
Gross profit
2,367
2,690
Operating expenses
General and administrative
8,275
5,059
Sales and marketing
753
860
Depreciation and amortization
162
177
Total operating expenses
9,190
6,096
Operating loss
( 6,823 )
( 3,406 )
Non-operating income (expense)
Other expense
( 38 )
( 1 )
PPP loan forgiveness
1,287
-
Other income
59
8
Loss before income taxes
( 5,515 )
( 3,399 )
Income tax expense
-
-
Net loss
$ ( 5,515 )
$ ( 3,399 )
Net loss attributable to common stockholders
$ ( 5,515 )
$ ( 3,399 )
Net loss per share attributable to common stockholders (basic and diluted)
$ ( 0.26 )
$ ( 0.19 )
Weighted average number of shares of Common Stock outstanding (basic and diluted)
21,233
18,211
The
accompanying notes are an integral part of these unaudited consolidated financial statements.
5
VIVOS
THERAPEUTICS INC.
Unaudited
Consolidated Statements of Stockholders’ Equity (Deficit)
(In
Thousands)
Shares
Amount
Capital
Deficit
Total
Three Months Ended March 31, 2022 and 2021
Additional
Common Stock
Paid-in
Accumulated
Shares
Amount
Capital
Deficit
Total
Balances, December 31, 2020
18,209,452
2
52,250
( 35,335 )
25,575
Issuance of Common Stock:
To consultants for services
2,667
-
20
-
20
Fair value of warrants issued:
To consultants for services
-
-
232
-
232
For purchase of assets
-
-
136
-
136
Stock-based compensation expense
-
-
434
-
434
Net loss
-
-
-
( 3,399 )
( 3,399 )
Balances, March 31, 2021
18,212,119
$ 2
$ 53,072
$ ( 38,734 )
$ 22,998
Balances, December 31, 2021
23,012,119
2
81,160
( 55,623 )
25,539
Fair value of warrants issued:
To consultants for services
-
-
222
-
222
Stock-based compensation expense
-
-
609
-
609
Net loss
-
-
-
( 5,515 )
( 5,515 )
Balances, March 31, 2022
23,012,119
$ 2
$ 81,991
$ ( 61,138 )
$ 20,855
The
accompanying notes are an integral part of these unaudited consolidated financial statements.
6
VIVOS
THERAPEUTICS INC.
Unaudited
Consolidated Statements of Cash Flows
(In
Thousands)
2022
2021
Three Months Ended March 31,
2022
2021
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss
$ ( 5,515 )
$ ( 3,399 )
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation expense
609
434
Depreciation and amortization
41
177
Fair value of warrants issued for services
222
232
Common stock issued for services
-
20
Accretion of discount on note receivable
-
( 6 )
Forgiveness of indebtness income
( 1,265 )
-
Changes in operating assets and liabilities:
Accounts receivable
201
( 234 )
Operating lease assets and liabilities, net
( 19 )
48
Prepaid expenses and other current assets
( 680 )
( 255 )
Deposits
3
( 61 )
Accounts payable
( 42 )
( 1,409 )
Accrued expenses
419
728
Contract liability
( 56 )
( 136 )
Net cash used in operating activities
( 6,082 )
( 3,861 )
CASH FLOWS FROM INVESTING ACTIVITIES:
Acquisitions of property and equipment
( 120 )
( 262 )
Net cash used in investing activities
( 120 )
( 262 )
CASH FLOWS FROM FINANCING ACTIVITIES:
Principal payments on debt
-
( 25 )
Net cash provided by financing activities
-
( 25 )
Net decrease in cash and cash equivalents
( 6,202 )
( 4,148 )
Cash and cash equivalents at beginning of year
24,030
18,206
Cash and cash equivalents at end of year
$ 17,828
$ 14,058
SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION:
Cash paid for interest
$ 2
$ 5
Cash paid for income taxes
$ -
$ -
SUPPLEMENTAL DISCLOSURE OF NON-CASH INVESTING AND FINANCING ACTIVITIES:
Fair value of warrants issued in asset purchase
$ -
$ 136
The
accompanying notes are an integral part of these unaudited consolidated financial statements.
7
VIVOS
THERAPEUTICS INC.
Notes
to Unaudited Consolidated Financial Statements
NOTE
1 - ORGANIZATION, DESCRIPTION AND SIGNIFICANT ACCOUNTING POLICIES
Organization
BioModeling
Solutions, Inc. (“BioModeling”) was organized on March 20, 2007 as an Oregon limited liability company, and subsequently
incorporated in 2013. On August 16, 2016, BioModeling entered into a share exchange agreement (the “SEA”) with First Vivos,
Inc. (“First Vivos”), and Vivos Therapeutics, Inc. (“Vivos”), a Wyoming corporation established on July 7, 2016
to facilitate this share exchange combination transaction. Vivos was formerly named Corrective BioTechnologies, Inc. until its
name changed on September 6, 2016 to Vivos Biotechnologies and on March 2, 2018 to Vivos Therapeutics, Inc. and had no substantial pre-combination
business activities. First Vivos was incorporated in Texas on November 10, 2015. Pursuant to the SEA, all of the outstanding shares of
common stock and warrants of BioModeling and all of the shares of commons stock of First Vivos were exchanged for newly issued shares
of Class A common stock and warrants of Vivos, the legal acquirer.
The
transaction was accounted for as a reverse acquisition and recapitalization, with BioModeling as the acquirer for financial reporting
and accounting purposes. Upon the consummation of the merger, the historical financial statements of BioModeling became the Company’s
historical financial statements and recorded at their historical carrying amounts.
On
August 12, 2020, Vivos reincorporated from Wyoming to become a domestic Delaware corporation under Delaware General Corporate Law. Accordingly,
as used herein, the term “the Company,” “we,” “us.” “our” and similar terminology refer
to Vivos Therapeutics, Inc., a Delaware corporation and its consolidated subsidiaries. As used herein, the term “Common Stock”
refers to the common stock, $0.0001 par value per share, of Vivos Therapeutics, Inc., a Delaware corporation.
Description
of Business
The
Company is a medical technology company focused on the development and commercialization to dental practices of a patented oral appliance
technology and related treatments and training called The Vivos Method. The Company believes The Vivos Method represents the first non-surgical,
non-invasive and cost-effective treatment for people with dentofacial abnormalities and/or mild to moderate OSA and snoring in adults.
The Company’s business model is focused around dentists, and the Company’s program to train dentists and offer them other
value-added services in connection with their ordering and use of The Vivos Method for patients is called the Vivos Integrated Practice
(“VIP”) program.
Basis
of Presentation and Consolidation
The
accompanying unaudited consolidated financial statements, which include the accounts of the Company and its wholly owned subsidiaries
(BioModeling, First Vivos, Vivos Therapeutics (Canada) Inc., Vivos Management and Development, LLC and Vivos Del Mar Management, LLC),
are prepared in conformity with generally accepted accounting principles in the United States of America (“U.S. GAAP”). All
significant intercompany balances and transactions have been eliminated in consolidation.
Emerging
Growth Company
The
Company is an “emerging growth company,” as defined in Section 2(a) of the Securities Act, as modified by the Jumpstart Our
Business Startups Act of 2012 (the “JOBS Act”), and it may take advantage of certain exemptions from various reporting requirements
that are applicable to other public companies that are not emerging growth companies including, but not limited to, not being required
to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act of 2002 (the “Sarbanes-Oxley Act”),
reduced disclosure obligations regarding executive compensation, and exemptions from the requirements of holding a nonbinding advisory
vote on executive compensation and shareholder approval of any golden parachute payments not previously approved.
8
Further,
Section 102(b)(1) of the JOBS Act exempts emerging growth companies from being required to comply with new or revised financial accounting
standards until private companies (that is, those that have not had a Securities Act registration statement declared effective or do
not have a class of securities registered under the Securities Exchange Act of 1934, as amended (the “Exchange Act”)) are
required to comply with the new or revised financial accounting standards. The JOBS Act provides that a company can elect to opt out
of the extended transition period and comply with the requirements that apply to non-emerging growth companies but any such election
to opt out is irrevocable. The Company currently expects to retain its status as an emerging growth company until the year ending December
31, 2026, but this status could end sooner under certain circumstances.
Revenue
Recognition
The
Company generates revenue from the sale of products and services. Revenue is recognized when control of the products or services is transferred
to our customers in a way that reflects the consideration we expect to be entitled to in exchange for those products and services.
The
Company determines revenue recognition through the following five-step model, which entails:
1)
identification
of the promised goods or services in the contract;
2)
determination
of whether the promised goods or services are performance obligations, including whether they are distinct in the context of the
contract;
3)
measurement
of the transaction price, including the constraint on variable consideration;
4)
allocation
of the transaction price to the performance obligations; and
5)
recognition
of revenue when, or as the Company satisfies each performance obligation.
Service
revenue
The
Company reviews its VIP contracts using the 5-step method outlined above. Once it is determined that a contract exists, service revenue
is recognized when the underlying training or other services are performed. Unearned revenue reported on the balance sheet as contract
liabilities represents the portion of fees paid by customers for services that have not yet been performed as of the reporting
date and are recorded as the service is rendered. The Company recognizes this revenue as performance obligations are met, which is
typically over the twelve-month life of the contract. Provisions for discounts are provided in the same period that the related revenue
from the products and/or services is recorded.
The
Company enters into programs that may provide for multiple performance obligations. Commencing in 2018, the Company began enrolling
medical and dental professionals in a one-year program which includes training in a highly personalized, deep immersion workshop format
which provides the dentist access to a global team who is dedicated to creating a successful integrated practice. The key topics covered
in training include case selection, clinical diagnosis, appliance design, adjunctive therapies, instructions on ordering the Company’s
products, guidance on pricing, instruction on insurance reimbursement protocols and interacting with our proprietary software system
and the many features on the Company’s website. The initial training and educational workshop is typically provided within the
first 30 to 45 days that a Vivos Integrated Provider (“VIP” or “Provider”) enrolls. Ongoing support and additional
training is provided throughout the year and includes access to the Company’s proprietary Airway Intelligence Service (“AIS”)
which provides the Provider with resources to help simplify the diagnostic and treatment planning process. AIS is provided as part of
the price of each appliance and is not a separate revenue stream. Following the year of training and support, the Provider may pay for
seminars and training courses that meet the Provider’s needs on a subscription or a course-by-course basis.
In
addition to enrollment service revenue, in 2020 the Company launched an additional service on a monthly subscription basis, its Billing
Intelligence Service (“BIS”), which includes the Company’s the
AireO2 medical billing and practice management software . Revenue for these services is recognized monthly during the month
the services are rendered.
Also,
the Company offers its VIPs the ability to provide an orofacial myofunctional therapy service (“OMT”) to the VIP’s
patients as part of treatment with The Vivos Method. Revenue for OMT services is recognized at the time training is booked and payment
is collected.
9
The
Company identifies all goods and services that are delivered separately under a sales arrangement and allocates revenue to each performance
obligations based on relative fair values. Fair values approximates the prices for relevant training that would be charged if those
services were sold separately, and are recognized over the relevant service period. In general, revenues are separated between
durable medical equipment (product revenue) and education and training services (service revenue). The allocated revenue for each deliverable
is then recognized ratably based on relative fair values of the components of the sale. Revenue from training is recognized over the
relevant service period, i.e., as the Company satisfies its performance obligations and creates value for the Provider. The Company also
evaluates the impact of undelivered items on the functionality of delivered items for each sales transaction and, where appropriate,
defers revenue on delivered items when that functionality has been affected. Functionality is determined to be met if the delivered products
or services represent a separate earnings process.
From
time to time, the Company offers various discounts to its customers. These include the following:
1)
Discount for cash paid in full
2)
Conference or trade show incentives, such as subscription
enrollment into the VivoScore program, or free trial period for the VivoScore lease program
3)
Negotiated concessions on annual enrollment fee
4)
Credits/rebates to be
used towards future product orders such as lab rebates
The
amount of the discount is determined up front prior to the sale. Accordingly, measurement is determined before the sale occurs and revenue
is recognized based on the terms agreed upon between the Company and the customer over the performance period. In rare circumstances,
a discount has been given after the sale during a conference which is offering a discount to full price. In this situation revenue is
measured and the change in transaction price is allocated over the remaining performance obligation.
The
amount of consideration can vary by customer due to promotions and discounts authorized to incentivize a sale. Prior to the sale, the
customer and the Company agree upon the amount of consideration that the customer will pay in exchange for the services the Company provides.
The net consideration that the customer has agreed to pay is the expected value that is recognized as revenue over the service period. At the end of each reporting period,
the Company updates the transaction price to represent the circumstances present at the end of the reporting period and any changes in
circumstances during the reporting period.
Product
revenue
In
addition to revenue from services, the Company also generates revenue from the sale of its patented oral devices and preformed guides,
known as appliances or systems to its customer, the Provider. Revenue from the appliance sale is recognized when control of product is
transferred to the Provider in an amount that reflects the consideration it expects to be entitled to in exchange for those products.
The Provider in turn charges the Provider’s patient and or patient’s insurance a fee for the appliance and for his or her
professional services in measuring, fitting, installing the appliance and educating the patient as to its use. The Company is contracted
with the Provider for the sale of the appliance and is not involved in the sale of the products and services from the Provider to the
Provider’s patient.
The
appliance is similar to a retainer that is worn after braces are removed. Each appliance is unique and is fitted to the patient. The
Company utilizes its network of certified dental Providers throughout the country to sell the appliances to their customers as well as
in two centers that the Company operates. The Company utilizes third party contract manufacturers or labs to produce its unique, patented
appliances and preformed guides. The manufacturer designated by the Company produces the appliance in strict adherence to the Company’s
patents, design files, protocols, processes and procedures and under the direction and specific instruction of the Company, ships the
appliance to the Provider who ordered the appliance from the Company. All of the Company’s contract manufacturers are required
to follow the Company’s master design files in production of appliances or the lab will be in violation of the FDA’s rules
and regulations. The Company performed an analysis under ASC Topic 606-10-55-36 through 55-40 and concluded it is the principal in the
transaction and is reporting revenue gross. The Company bills the Provider the contracted price for the appliance which is recorded as
product revenue. Product revenue is recognized once the appliance ships to the Provider under the direction of the Company.
10
Within
each center, the Company utilizes a team of medical professionals to measure, order and fit each appliance. Upon scheduling the patient
(which is the Company’s customer in this case), the center takes a deposit and reviews the patient’s insurance coverage.
Revenue is recognized differently for our Company owned centers than for its Providers. The Company recognizes revenue in the centers
after the appliance is received from the manufacturer and once the appliance is fitted and provided to the patient.
The
Company offers its Clinical Advisors discounts from our standard Provider pricing. This is done to help encourage our Clinical Advisors,
who help the Provider with technical aspects of our products, to purchase our products for their own practices. In addition, from time
to time, we offer credits to incentivize our Providers to embrace our products and increase volume within their practices,
these are recorded as a liability for use in future periods.
Use
of Estimates
The
preparation of financial statements and related disclosures in conformity with U.S. GAAP requires the Company to make judgments, assumptions,
and estimates that affect the amounts reported in its consolidated financial statements and accompanying notes. The Company bases its
estimates and assumptions on existing facts, historical experience, and various other factors that it believes are reasonable under the
circumstances, to determine the carrying values of assets and liabilities that are not readily apparent from other sources. The Company’s
significant accounting estimates include, but are not necessarily limited to, assessing collectability on accounts receivable and notes
receivable, impairment of goodwill and long-lived assets; valuation assumptions for assets acquired in business combinations; valuation
assumptions for stock options, warrants and equity instruments issued for goods or services; deferred income taxes and the related valuation
allowances; and the evaluation and measurement of contingencies. Additionally, the full impact of COVID-19 is unknown and cannot be reasonably
estimated. However, the Company has made appropriate accounting estimates based on the facts and circumstances available as of the reporting
date. To the extent there are material differences between the Company’s estimates and the actual results, the Company’s
future consolidated results of operations will be affected.
Cash
and Cash Equivalents
All
highly liquid investments purchased with an original maturity of three months or less that are freely available for the Company’s
immediate and general business use are classified as cash and cash equivalents.
Accounts
Receivable, Net
The
accounts receivable in the accompanying financial statements are stated at the amounts management expects to collect. The Company performs
credit evaluations of its customers’ financial condition and may require a prepayment for a portion of the services to be performed.
The Company reduces accounts receivable by estimating an allowance that may become uncollectible in the future. Management determines
the estimated allowance for uncollectible amounts based on its judgements in evaluating the aging of the receivables and the financial
condition of our clients.
Property
and Equipment, Net
Property
and equipment are stated at historical cost less accumulated depreciation. Depreciation is computed using the straight-line method over
the estimated useful lives of the assets, which ranges from 4 to 5 years. Amortization of leasehold improvements is recognized using
the straight-line method over the shorter of the life of the improvement or the term of the respective leases which range between 5 and
7 years. The Company does not begin depreciating assets until they are placed in service.
Intangible
Assets, Net
Intangible
assets consist of assets acquired from First Vivos and costs paid to (i) MyoCorrect, LLC (“MyoCorrect”), from whom the Company
acquired certain assets related to its OMT service in March 2021 and (ii) Lyon Management and Consulting, LLC and its affiliates (“Lyon
Dental”), from whom the Company acquired certain medical billing and practice management software, licenses and contracts in April
2021 (including the software underlying AireO2) for work related to the Company’s acquired patents, intellectual property and customer
contracts. The identifiable intangible assets acquired from First Vivos and Lyon Dental for customer contracts are amortized using the
straight-line method over the estimated life of the assets, which approximates 5 years (See Note 5). The costs paid to MyoCorrect and
Lyon Dental for patents and intellectual property are amortized over the life of the underlying patents, which approximates 15 years.
11
Goodwill
Goodwill
is the excess of acquisition cost of an acquired entity over the fair value of the identifiable net assets acquired. Goodwill is not
amortized but tested for impairment annually or whenever indicators of impairment exist. These indicators may include a significant change
in the business climate, legal factors, operating performance indicators, competition, sale or disposition of a significant portion of
the business or other factors. We test for impairment annually after the close of the year. There was no impairment of goodwill recognized
at December 31, 2021. There were no indicators of impairment that occurred for the three months ended March 31, 2022 and accordingly, no impairment
was required.
Impairment
of Long-lived Assets
We
review and evaluate the recoverability of long-lived assets whenever events or changes in circumstances indicate that an asset’s
carrying amount may not be recoverable. Such circumstances could include, but are not limited to, (1) a significant decrease in the market
value of an asset, (2) a significant adverse change in the extent or manner in which an asset is used, or (3) an adverse action or assessment
by a regulator. We measure the carrying amount of the asset against the estimated undiscounted future cash flows associated with it.
Should the sum of the expected future net cash flows be less than the carrying value of the asset being evaluated, an impairment loss
would be recognized. The impairment loss would be calculated as the amount by which the carrying value of the asset exceeds its fair
value. The fair value is measured based on quoted market prices, if available. If quoted market prices are not available, the estimate
of fair value is based on various valuation techniques, including the discounted value of estimated future cash flows. The evaluation
of asset impairment requires us to make assumptions about future cash flows over the life of the asset being evaluated. These assumptions
require significant judgment and actual results may differ from assumed and estimated amounts. Our evaluation of long-lived assets completed
for the years ended December 31, 2021 resulted in no impairment loss. No triggering events indicating potential impairment were identified
for the three months ended March 31, 2022.
Equity
Offering Costs
Commissions,
legal fees and other costs that are directly associated with equity offerings are capitalized as deferred offering costs, pending a determination
of the success of the offering. Deferred offering costs related to successful offerings are charged to additional paid-in capital in
the period it is determined that the offering was successful. Deferred offering costs related to unsuccessful equity offerings are recorded
as expense in the period when it is determined that an offering is unsuccessful.
Accounting
for Payroll Protection Program Loan
The
Company is accounting for its U.S. Small Business Administration’s (“SBA”) Payroll Protection Program (“PPP”)
loan as a debt instrument under ASC 470, Debt . The Company recognized the original principal balance as a financial liability
with interest accrued at the contractual rate over the term of the loan. On January 21, 2022 the PPP loan received by the Company on
May 8, 2020 was forgiven by the SBA in its entirety, which includes approximately $ 1.3
million in principal. As a result, the Company
recorded a gain on the forgiveness of the loan in the quarter ended March 31, 2022 under non-operating income (expense).
12
Loss
and Gain Contingencies
The
Company is subject to the possibility of various loss contingencies arising in the ordinary course of business. An estimated loss contingency
is accrued when it is probable that an asset has been impaired, or a liability has been incurred, and the amount of loss can be reasonably
estimated. If some amount within a range of loss appears to be a better estimate than any other amount within the range, the Company
accrues that amount. Alternatively, when no amount within a range of loss appears to be a better estimate than any other amount, the
Company accrues the lowest amount in the range. If the Company determines that a loss is reasonably possible and the range of the loss
is estimable, then the Company discloses the range of the possible loss. If the Company cannot estimate the range of loss, it will disclose
the reason why it cannot estimate the range of loss. The Company regularly evaluates current information available to it to determine
whether an accrual is required, an accrual should be adjusted and if a range of possible loss should be disclosed. Legal fees related
to contingencies are charged to general and administrative expense as incurred. Contingencies that may result in gains are not recognized
until realization is assured, which typically requires collection in cash.
Share-Based
Compensation
The
Company measures the cost of employee and director services received in exchange for all equity awards granted, including stock options,
based on the fair market value of the award as of the grant date. The Company computes the fair value of stock options using the Black-Scholes-Merton
(“BSM”) option pricing model. The Company estimates the expected term using the simplified method which is the average of
the vesting term and the contractual term of the respective options. The Company determines the expected price volatility based on the
historical volatilities of shares of the Company’s peer group as the Company does not have a sufficient trading history for its
Common Stock. Industry peers consist of several public companies in the bio-tech industry similar to the Company in size, stage of life
cycle and financial leverage. The Company intends to continue to consistently apply this process using the same or similar public companies
until a sufficient amount of historical information regarding the volatility of the Company’s own stock price becomes available,
or unless circumstances change such that the identified companies are no longer similar to the Company, in which case, more suitable
companies whose share prices are publicly available would be utilized in the calculation. The Company recognizes the cost of the equity
awards over the period that services are provided to earn the award, usually the vesting period. For awards granted which contain a graded
vesting schedule, and the only condition for vesting is a service condition, compensation cost is recognized as an expense on a straight-line
basis over the requisite service period as if the award were, in substance, a single award. The Company recognizes the impact of forfeitures
in the period that the forfeiture occurs, rather than estimating the number of awards that are not expected to vest in accounting for
stock-based compensation. Prior to public trading of the Company’s shares which commenced in December 2020, the Company estimated
fair value of its shares based on the most recent sales to third parties.
Research
and Development
Costs
related to research and development are expensed as incurred and include costs associated with research and development of new products
and enhancements to existing products. Research and development costs incurred were approximately $ 0.1 million for the three months ended
March 31, 2022 and less than $ 0.1 million for the three months ended March 31, 2021.
Leases
Operating
leases are included in operating lease right-of-use (“ROU”) asset, accrued expenses, and operating lease liability –
current and non-current portion in our balance sheets. ROU assets represent our right to use an underlying asset for the lease term and
lease liabilities represent our obligation to make lease payments arising from the lease. Operating lease ROU assets and liabilities
are recognized at the lease commencement date based on the present value of lease payments over the lease term. In determining the present
value of lease payments, we use our incremental borrowing rate based on the information available at the lease commencement date as the
rate implicit in the lease is not readily determinable. The determination of our incremental borrowing rate requires management judgment
based on information available at lease commencement. The operating lease ROU assets also include adjustments for prepayments, accrued
lease payments and exclude lease incentives. Our lease terms may include options to extend or terminate the lease when it is reasonably
certain that we will exercise such options. Operating lease cost is recognized on a straight-line basis over the expected lease term.
Lease agreements entered into after the adoption of ASC 842 that include lease and non-lease components are accounted for as a single
lease component. Lease agreements with a noncancelable term of less than 12 months are not recorded on our balance sheets.
13
Income
Taxes
The
Company accounts for income taxes in accordance with Accounting Standards Codification (“ASC”) 740, Income Taxes, under which
deferred income taxes are recognized based on the estimated future tax effects of differences between the financial statement and tax
bases of assets and liabilities given the provisions of enacted tax laws. Deferred income tax provisions and benefits are based on changes
to the assets or liabilities from year to year. In providing for deferred taxes, the Company considers tax regulations of the jurisdictions
in which the Company operates, estimates of future taxable income, and available tax planning strategies. If tax regulations, operating
results, or the ability to implement tax-planning strategies vary, adjustments to the carrying value of deferred tax assets and liabilities
may be required. A valuation allowance is recorded when it is more likely than not that a deferred tax asset will not be realized. The
recorded valuation allowance is based on significant estimates and judgments and if the facts and circumstances change, the valuation
allowance could materially change. In accounting for uncertainty in income taxes, the Company recognizes the financial statement benefit
of a tax position only after determining that the relevant tax authority would more likely than not sustain the position following an
audit. For tax positions meeting the more likely than not threshold, the amount recognized in the financial statements is the largest
benefit that has a greater than 50 percent likelihood of being realized upon ultimate settlement with the relevant tax authority. The
Company recognizes interest and penalties accrued on any unrecognized tax benefits as a component of income tax expense.
Basic
and Diluted Net Loss Per Share
Basic
net loss per common share is computed by dividing the net loss applicable to common stockholders by the weighted average number of common
shares outstanding for each period presented. Diluted net loss per common share is computed by giving effect to all potential shares
of Common Stock, including stock options, convertible debt, Preferred Stock, and warrants, to the extent dilutive.
Recent
Accounting Pronouncements
Presented
below is a discussion of new accounting standards including deadlines for adoption assuming that the Company retains its designation
as an EGC.
Standards
Required to be Adopted in Future Years. The following accounting standards are not yet effective as of March 31, 2022.
In
June 2016, the FASB issued ASU 2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial
Instruments. ASU 2016-13 amends the guidance on the impairment of financial instruments. This guidance requires use of an impairment
model (known as the “current expected credit losses”, or CECL model) that is based on expected losses rather than incurred
losses. Under the new guidance, an entity recognizes, as an allowance, its estimate of expected credit losses. ASU 2016-13 is effective
for the Company beginning in the first quarter of 2023. The Company is still evaluating the impact the adoption of ASU 2016-13 will have
on its results of operations or financial position.
Other
accounting standards that have been issued or proposed by the FASB or other standards-setting bodies that do not require adoption until
a future date are not currently expected to have a material impact on the Company’s financial statements upon adoption.
Recently
Adopted Standards. The following recently issued accounting standards were adopted by the Company during the year ended March 31,
2022:
In
February 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2016-02,
Leases (Topic 842). This ASU requires the Company to recognize lease assets and lease liabilities on the balance sheet and also
disclose key information about leasing arrangements. In July 2018, the FASB issued ASU No. 2018-11 Targeted Improvements , which
provides lessees the option to adopt either (i) retrospectively to each prior reporting period presented upon initial adoption, or (ii)
apply the new leasing standard to all open leases as of the adoption date by recognizing a cumulative-effect adjustment to accumulated
deficit in the period of adoption without restating prior periods. The Company adopted the new accounting standard on January 1, 2022,
this adoption required the company to recognize a current and long-term lease liability of approximately of $ 2.3 million and a right-of-use
(ROU) asset of approximately $ 1.6 million. We applied the new lease standard to all open leases as of the adoption date, with no retrospective
adjustments to prior comparative periods.
14
In
December 2019, the FASB issued ASU 2019-12 , Income Taxes (Topic 740), Simplifying the Accounting for Income Taxes , which is intended
to simplify various aspects related to accounting for income taxes. ASU 2019-12 removes certain exceptions to the general principles
in Topic 740 and clarifies and amends existing guidance to improve consistent application. ASU 2019-12 was effective for the Company
beginning in the first quarter of 2022. The adoption of this standard did not have a material impact on the Company’s consolidated
financial statements.
NOTE
2 – LIQUIDITY
As
of March 31, 2022, the Company had an accumulated deficit of $ 61.1
million. For the three months ended March
31, 2022 and 2021, the Company incurred a net loss of $ 5.5
and $ 3.4
million, respectively. Net cash used in operating
activities amounted to $ 6.1
million and $ 3.9
million for the three months ended March 31,
2022 and 2021, respectively. Since March 2020, the Company’s business has been negatively impacted as a result of the COVID-19
pandemic. Revenue growth and collections in 2021 were impacted by significant headwinds throughout the Company’s core customer
base, mostly driven by COVID-19 Delta and Omicron variant resurgences in the middle and latter part of the year as discussed in Note
13.
As
of March 31, 2022, the Company has cash and cash equivalents of $ 17.8 million and total liabilities of $ 8.7 million.
Management
believes the Company’s existing cash resources will be sufficient to fund the Company’s contractual obligations and working
capital requirements at least through a year from the date of this filing.
NOTE
3 – REVENUE, CONTRACT ASSETS AND CONTRACT LIABILITIES
Net
Revenue
For
the three months ended March 31, 2022 and 2021, the components of revenue from contracts with customers and the related timing of revenue
recognition is set forth in the table below (in thousands):
SCHEDULE
OF REVENUE FROM CONTRACT WITH CUSTOMERS
Three Months Ended March 31,
2022
2021
Product revenue:
Appliance sales to VIPs
$ 1,536 (1)
$ 1,295 (1)
Center revenue
186
92
Total product revenue
1,722
1,387
Service revenue
VIP
1,237
1,753
Billing intelligence services
216 (2)
203 (2)
Management service revenue (includes MID)
24
59
Sponsorship/seminar/other
261
46
Total service revenue
1,738
2,061
Total revenue
$ 3,460
$ 3,448
(1)
Revenue
from the sale of products is typically fixed at inception of the contract and is recognized at the point in time when shipment of
the related products occurs.
(2)
Revenue
from maintenance and subscription contracts is typically fixed at inception of the contract and is recognized ratably over time as
the services are performed and the performance obligations completed.
15
Changes
in Contract Liabilities
The
key components of changes in contract liabilities for the three months ended March 31, 2022 and 2021 are as follows (in thousands):
SCHEDULE
OF CONTRACT LIABILITY
March 31,
2022
2021
Balance at beginning of year
$ 2,399
$ 2,938
New contracts, net of cancellations
1,182
1,617
Revenue recognized
( 1,237 )
( 1,753 )
Balance at end of year
$ 2,344
$ 2,802
Deferred
revenue is expected to be recognized over the next 12 months from the date of enrollment .
Shipping
Costs
Shipping
costs for product deliveries to customers are expensed as incurred and totaled approximately $ 0.1 million for the three months ended
March 31, 2022 and 2021. Shipping costs for product deliveries to customers are included in cost of goods sold in the accompanying unaudited
consolidated statement of operations.
NOTE
4 - PROPERTY AND EQUIPMENT, NET
As
of March 31, 2022 and December 31, 2021, property and equipment consist of the following (in thousands):
SCHEDULE
OF PROPERTY AND EQUIPMENT
March 31,
December 31,
2022
2021
Furniture and equipment
$ 1,272
$ 1,394
Leasehold improvements
2,397
2,387
Construction in progress
444
212
Molds
75
75
Gross property and equipment
4,188
4,068
Less accumulated depreciation
( 1,275 )
( 1,243 )
Net Property and equipment
$ 2,913
$ 2,825
Leasehold
improvements relate to the Vivos Institute (the Company’s 15,000 square foot facility where the Company provides advanced post-graduate
education and certification to dentists, dental teams, and other healthcare professionals in a live and hands-on setting) and the two
Company-owned dental centers in Colorado. Total depreciation and amortization expense was $ 0.2 million and $ 0.1 million for the three
months ended March 31, 2022 and 2021, respectively
NOTE
5 – GOODWILL AND INTANGIBLE ASSETS
Goodwill
Goodwill
by reporting unit consisted of the following as of March 31, 2022 and December 31, 2021 (in thousands):
SCHEDULE
OF GOODWILL
March 31,
December 31,
Reporting Unit
2022
2021
BioModeling
$ 2,619
$ 2,619
Empowered Dental
52
52
Lyon Dental
172
172
Total goodwill
$ 2,843
$ 2,843
16
In August 16,
2016, BioModeling entered into a share exchange agreement (the “SEA”) with First Vivos, Inc. (“First Vivos”), and
Vivos Therapeutics, Inc. (“Vivos”). The transaction was accounted for as a reverse acquisition and recapitalization, with
BioModeling as the acquirer for financial reporting and accounting purposes. As a result of the transaction we
identified intangible assets of $ 2.1 million and goodwill (including the acquired workforce) of $ 2.6 million was recorded in accounting
for the reverse acquisition.
In November 2018,
the Company entered into an asset purchase agreement with Empowered Dental Lab, LLC, a Utah limited liability company (“Empowered
Dental”), under which the Company agreed to purchase certain inventory and assets from Empowered Dental in exchange for total consideration
of $ 75,000 . As a result of the transaction, goodwill of $ 52,000 was recognized in accounting for this transaction
as a business combination.
On
April 14, 2021, the Company acquired certain assets of Lyon Dental. The business acquisition allowed the Company to expand and
enhance its current medical billing practice services under the name AireO2, which services are provided through the Company’s
BIS offering. The consideration transferred includes $ 0.2
million in cash and a warrant to purchase
25,000
shares of Common Stock
at a price of $ 8.90
per share fair valued using a Black-Scholes Model
as of April 14, 2021 for a total of $ 0.2
million, when combined the total consideration
exchanged is $ 0.4
million, the excess of the consideration transferred
over the fair value of the acquired assets was allocated to goodwill.
Intangible
Assets
As
of March 31, 2022 and December 31, 2021, identifiable intangible assets were as follows (in thousands):
SCHEDULE
OF IDENTIFIABLE INTANGIBLES
March 31,
December 31,
2022
2021
Patents and developed technology
$ 2,136
$ 2,136
Trade name
330
330
Other
27
27
Total intangible assets
2,493
2,493
Less accumulated amortization
( 2,162 )
( 2,152 )
Net intangible assets
$ 331
$ 341
Amortization
expense of identifiable intangible assets was less than $ 0.1 million and $ 0.1 million for the years ended March 31, 2022 and 2021. The
estimated future amortization of identifiable intangible assets is as follows (in thousands):
SCHEDULE
OF ESTIMATED FUTURE AMORTIZATION OF IDENTIFIABLE INTANGIBLE ASSETS
Three Months Ending March 31,
2022 (remaining nine months)
$ 29
2023
39
2024
39
2025
39
2026
23
Thereafter
162
Total
$ 331
NOTE
6 – OTHER FINANCIAL INFORMATION
Accrued
Expenses
Accrued
expenses consist of the following (in thousands):
SCHEDULE
OF ACCRUED EXPENSES
March 31,
December 31,
2022
2021
Accrued payroll
$ 1,503
$ 1,397
Accrued legal and other
1,235
990
Lab rebate liabilities
434
466
Total accrued liabilities
$ 3,172
$ 2,853
17
NOTE
7 - DEBT
PPP
Loan
On
May 8, 2020, the Company received approximately $ 1.3 million in loan funding through the PPP that was part of the Coronavirus Aid, Relief,
and Economic Security Act (the “CARES Act”) signed into law in March 2020. The interest rate on the loan is 1.00 % per year
and was scheduled to mature on May 5, 2022 . The Company used these funds to assist with payroll, rent and utilities. On January 21, 2022
the PPP loan was forgiven by the SBA in its entirety. As a result, the Company recorded other income on the forgiveness of the loan in
the first quarter of 2022.
NOTE
8 – PREFERRED STOCK
The
Company’s Board of Directors has authority to issue up to 50,000,000 shares
of Preferred Stock. At December 31, 2020, all previously issued shares of Preferred Stock had been redeemed or converted to shares
of Common Stock. As of March 31, 2022, the Company’s Board of Directors has authority to designate up to an additional 47.8 million
shares of Preferred Stock in various series that provide for liquidation preferences, and voting, dividend, conversion, and
redemption rights as determined at the discretion of the Board of Directors.
NOTE
9 – COMMON STOCK
The
Company is authorized to issue 200,000,000 shares of Common Stock. Holders of Common Stock are entitled to one vote for each share held.
The Company’s Board of Directors may declare dividends payable to the holders of Common Stock.
NOTE
10 – STOCK OPTIONS AND WARRANTS
Stock
Options
In
2017, the Company’s shareholders approved the adoption of a stock and option award plan (the “2017 Plan”), under which
shares were reserved for future issuance for Common Stock options, restricted stock awards and other equity awards. The 2017 Plan permits
grants of equity awards to employees, directors, consultants and other independent contractors. The Company’s shareholders have
approved a total reserve of 1,333,333 million shares of Common Stock for issuance under the 2017 Plan.
In
April 2019, the Company’s shareholders approved the adoption of a stock and option award plan (the “2019 Plan”), under
which shares were reserved for future issuance for Common Stock options, restricted stock awards and other equity awards. The 2019 Plan
permits grants of equity awards to employees, directors, consultants and other independent contractors. The Company’s shareholders
originally approved a total reserve of 333,334 shares of Common Stock for issuance under the 2019 Plan. At each of the Company’s
annual meeting of stockholders held in 2020 and 2021, the Company’s stockholders approved amendments to the 2019 Plan to increase
the number of shares of Common Stock available for issuance thereunder by an aggregate of 2,033,333 shares of Common Stock such that,
after such amendments, and prior to any grants, 2,366,667 shares of Common Stock were available for issuance.
18
During
the three months ended March 31, 2022 and 2021, the Company issued stock options to purchase 290,000
and 145,000
shares of Common Stock at a weighted average
exercise price of $ 3.27
and $ 7.50
per share, respectively, to certain members of
the Board of Directors, employees and consultants. The stock options allow the holders to purchase shares of Common Stock at prices between
$ 1.50
and $ 7.50
per share. Options for the purchase of 203,335
shares of Common Stock expired as of March 31,
2022. The following table summarizes all stock options as of March 31, 2022 and 2021 (shares in thousands):
SCHEDULE
OF STOCK OPTIONS
2022
Shares
Price (1)
Term (2)
Outstanding, beginning of year
2,851
$ 5.00
1.1
Grants
290
5.23
Forfeited
( 203 )
-
Exercised
-
-
Outstanding, at March 31
2,938
(3)
4.86
2.9
Exercisable, at March 31
1,950 (4)
4.50
4.42
(1)
Represents
the weighted average exercise price.
(2)
Represents
the weighted average remaining contractual term until the stock options expire.
(3)
As
of March 31, 2022, the aggregate intrinsic value of stock options outstanding was $ 0.8 million.
(4)
As
of March 31, 2022, the aggregate intrinsic value of exercisable stock options was $ 0.8 million.
For
the three months ended March 31, 2022 and 2021, the valuation assumptions for stock options granted under the 2017 Plan and the 2019
Plan were estimated on the date of grant using the BSM option-pricing model with the following weighted-average assumptions:
SCHEDULE
OF WEIGHTED AVERAGE ASSUMPTIONS USED IN THE FAIR VALUE
2022
Grant date closing price of Common Stock
$ 3.27
Expected term (years)
3.5
Risk-free interest rate
1.9 %
Volatility
135 %
Dividend yield
0 %
Based
on the assumptions set forth above, the weighted-average grant date fair value per share for stock options granted for the three months
ended March 31, 2022 and 2021 was $ 2.61
and $ 5.00 ,
respectively.
For
the three months ended March 31, 2022 and 2021, the Company recognized approximately $ 0.6 million and $ 0.4 million, respectively, of
share-based compensation expense relating to the vesting of stock options. Unrecognized expense relating to these awards as of March
31, 2022 was approximately $ 5.4 million, which will be recognized over the weighted average remaining term of 2.9 years as of March 31,
2022.
19
Warrants
The
following table sets forth activity with respect to the Company’s warrants to purchase Common Stock for the three months ended
March 31, 2022 and 2021 (shares in thousands):
SCHEDULE
OF WARRANT OUTSTANDING
2022
Shares
Price (1)
Term (2)
Outstanding, beginning of year
2,556
$ 7.44
2.6
Grants of warrants:
Consultants for services
80 (3)
2.44
Acquisition of assets
-
-
Outstanding, March 31
2,636 (4)
7.31
2.5
Exercisable, March 31
2,369 (5)
7.36
2.5
(1)
Represents
the weighted average exercise price.
(2)
Represents
the weighted average remaining contractual term until the warrants expire.
(3)
In
February, 2022, the Company granted warrants to consultants in exchange for services. Warrants issued in February 2022 provide for
the purchase of an aggregate of 80,000 shares of Common Stock and are exercisable at $ 3.27 per share. The aggregate fair value of
the February warrants amounted to $ 0.1 million which is being recognized over the period that the services are provided. For the
three month ended March 31, 2022, the Company recognized expense of $ 0.2 million.
(4)
As
of March 31, 2022, the aggregate intrinsic value of warrants outstanding was $ 0 .
(5)
As
of March 31, 2022, the aggregate intrinsic value of vested warrants was $ 0 .
For
the three months ended March 31, 2022 and 2021, the valuation assumptions for warrants issued were estimated on the measurement
date using the BSM option-pricing model with the following weighted-average assumptions:
SCHEDULE
OF WEIGHTED AVERAGE ASSUMPTIONS USED IN THE FAIR VALUE
2022
Measurement date closing price of Common Stock (1)
$ 3.27
Contractual term (years) (2)
5.0
Risk-free interest rate
1.9 %
Volatility
135 %
Dividend yield
0 %
(1)
Weighted
average grant price.
(2)
The
valuation of warrants is based on the contractual term of the warrant rather than the expected term.
20
NOTE
11 - RELATED PARTY TRANSACTIONS
For
the three months ended March 31, 2022 and 2021, options for the purchase of 290,000 and 145,000 , respectively, of common stock were granted
to the Company’s directors, officers, employees and consultants.
NOTE
12 - INCOME TAXES
Income
tax expense during interim periods is based on applying an estimated annual effective income tax rate to year-to-date income, plus any
significant unusual or infrequently occurring items which are recorded in the interim period. The provision for income taxes for the
three months ended March 31, 2022 and 2021 differs from the amount that would be provided by applying the statutory U.S. federal income
tax rate of 21 % to pre-tax income primarily due to permanent differences, state taxes and change in valuation allowance. A full valuation
allowance was in effect, which resulted in the Company’s zero tax expense.
Management
assesses the available positive and negative evidence to estimate if sufficient future taxable income will be generated to use the existing
deferred tax assets. A significant piece of objective negative evidence evaluated was the cumulative loss incurred since inception. Such
objective evidence limits the ability to consider other subjective evidence such as the Company’s projections for future growth.
On the basis of this evaluation, a full valuation allowance has been recorded at March 31, 2022 and December 31, 2021 to record the deferred
tax asset that is not likely to be realized.
The
computation of the annual estimated effective tax rate at each interim period requires certain estimates and significant judgement including,
but not limited to, the expected operating income for the year, projections of the proportion of income earned and taxed in various jurisdictions,
permanent and temporary differences, and the likelihood of recovering deferred tax assets generated in the current year. The accounting
estimates used to compute the provision for income taxes may change as new events occur, more experience is obtained, additional information
becomes known or as the tax environment changes.
NOTE
13 – COMMITMENTS AND CONTINGENCIES
COVID-19
Pandemic
In
December 2019, a novel strain of coronavirus known as COVID-19 was reported to have surfaced in China, and by March 2020 the spread of
the virus resulted in a world-wide pandemic. By March 2020, the U.S. economy had been largely shut down by mass quarantines and government
mandated stay-in-place orders (the “Orders”) to halt the spread of the virus. Many of these Orders have been relaxed or lifted
in jurisdictions where large portions of the population have been vaccinated, but there is considerable uncertainty about whether the
Orders will need to be reinstated due to the ongoing spread of new variants of COVID-19. A significant portion of the worldwide population
remains unvaccinated, and uncertainty also exists about whether existing vaccines will be effective as new variants of COVID-19 emerge.
Accordingly, the overall impact of COVID-19 continues to have an adverse impact on global business activities.
21
Many
of our VIPs and potential VIPs closed their offices during 2020 as a result of COVID-19, although some remained open to specifically
provide patients our products as our appliances and VIPs were deemed an essential business for health considerations in many jurisdictions.
In the face of the pandemic and the results potential for revenue reduction, we worked diligently to reduce expenses and maintain revenues
during 2020. While revenue growth flattened in March and April 2020, expenses were reduced and we aggressively expanded our network of
healthcare providers familiar with our products by offering online continuing education courses which introduced many in the medical
and dental communities to our product line. As businesses continued to reopen through 2021, the impact of COVID-19 on our company began
to diminish, although we continue to closely monitor the potential impact of COVID-19 variants on our business. Of note, during the second
half of 2021, many of our Canadian VIPs have not traveled to the U.S. for training in light of travel restrictions. As of August 9, 2021,
the Government of Canada imposed further restrictions on unvaccinated travelers, which has caused delays with some of our Canadian VIPs
receiving required training and commencing Vivos Method cases.
In
addition, our fourth quarter 2021 revenue growth was impacted by lower VIP enrollments due largely to the COVID-19 Omicron variant resurgence.
We achieved sales growth despite seeing significant headwinds throughout our core customer base, mostly driven by COVID-19 Delta and
Omicron variant resurgences in the middle and latter part of the year. In December 2021, the American Dental Association reported that
just 60% of dental practices were open and operating with business as usual. Another industry source reported 92% of dental practices
were struggling to hire or replace hygienists, and 77% reported difficulty hiring front desk positions. These challenges across the dental
community have impacted both VIP enrollments and patient case starts, as replacement dental personnel must be trained in the proper use
of The Vivos Method. The world-wide response to the pandemic resulted in a significant downturn in economic activity, which continued
into 2022 as a new variant (called B.A.2) has emerged and there remains is a risk that new variant outbreaks will cause additional
disruptions and slowdowns in the economy.
As
such, the long-term financial impact on our business of COVID-19 as well as these other matters cannot reasonably be fully estimated
at this time.
Inflation
and War in Ukraine
The Company believes the U.S.
has entered a period of inflation which has increased (and may continue to increase) the Company and its suppliers’ costs as well
as the end cost of the Company’s products to consumers. To date, the Company been able to manage inflation risk without a material
adverse impact on its business or results of operations. However, inflationary pressures (including increases in the price of raw material
components of the Company’s appliances) made it necessary for the Company to adjust its standard pricing for its appliance products
effective May 1, 2022. The full impact of such price adjustments on sales or demand for the Company’s products is not fully known
at this time and may require the Company to adjust other aspects of its business as it seek to grow revenue and, ultimately, achieve
profitability and positive cash flow from operations.
In
addition, worldwide supply chain constraints due in part to Russia’s invasion of Ukraine in February 2022, have emerged
as new barriers to long-term economic recovery.
These
conditions could cause an economic recession or
depression to commence, and if such recession or depression is sustained, it could have a material adverse effect on the
Company business as demand for its products could decrease. Such conditions have also had, and may continue to have, an
adverse effect on the capital markets, with public stock price decreases and volatility, which could make it more difficult for the Company
to raise needed capital at the appropriate time.
Operating
Leases
The
Company has entered into various operating lease agreements for certain offices, medical facilities and training facilities. These leases
have original lease periods expiring between 2022 and 2029. Most leases include an option to renew and the exercise of a lease renewal
option typically occurs at the discretion of both parties. For purposes of calculating operating lease liabilities, lease terms are deemed
not to include options to extend the lease until it is reasonably certain that the Company will exercise that option.
In
January 2017, the Company entered into a commercial lease agreement for 2,220
square feet of office in Johnstown, CO that was
to commence on March 1, 2018 and end February 28, 2025. As of January 1, 2022, the Company recorded an operating lease right
of use asset and lease liabilities of $ 0.4
million in the consolidated balance sheet representing
the present value of minimum lease payments using the Company’s incremental borrowing rate of 6.9 %.
In
May 2018, the Company entered into a commercial lease agreement for 3,643
square feet of office in Highlands Ranch, CO
that was to commence on November 1, 2018 and end on January 1, 2029. As of January 1, 2022, the Company recorded an operating
lease right of use asset and lease liabilities of $ 1.4
million in the consolidated balance sheet representing
the present value of minimum lease payments using the Company’s incremental borrowing rate of 6.8 %.
22
In
October 2020, the Company entered into a commercial lease agreement for 4,800
square feet of office in Orem, Utah that was
to commence on January 1, 2021 and end on December 1, 2025. As of January 1, 2022, the Company recorded an operating lease right
of use asset and lease liabilities of $ 0.6
million in the consolidated balance sheet representing
the present value of minimum lease payments using the Company’s incremental borrowing rate of 6.9 %.
In
April 2019, the Company entered into a commercial lease agreement for 3,231
square feet of office in Highlands Ranch, CO
that was to commence on May 1, 2019 and end on May 31, 2022. As of January 1, 2022, the Company recorded an operating lease right
of use asset and lease liabilities of less than $ 0.1
million in the consolidated balance sheet representing
the present value of minimum lease payments using the Company’s incremental borrowing rate of 6.7 %.
In
April 2019, the Company entered into a commercial lease agreement for 14,732
square feet of office in Denver, CO that was
to commence on October 23, 2020 and end on March 22, 2028. As of January 1, 2022, the Company recorded an operating lease right
of use asset and lease liabilities of less than $ 1.4
million in the consolidated balance sheet representing
the present value of minimum lease payments using the Company’s incremental borrowing rate of 6.8 %.
For
the three months ended March 31, 2022 and 2021. the components of lease expense are as follows:
SCHEDULE
OF LEASE EXPENSE
Lease cost:
2022
Operating lease cost
$ 2,665
Total net lease cost
$ 2,665
Rent
expense, including real estate taxes and related costs, for the three months ended March 31, 2022 and 2021 aggregated approximately $ 0.2
million and $ 0.1
million, respectively. This is included under
general and administrative expense.
For
the three months ended March 31, 2022 and 2021, the remaining lease terms and discount rate used are as follows:
SCHEDULE
OF REMAINING LEASE TERMS AND DISCOUNT RATE
2022
Weighted-average remaining lease term (years)
5.64
Weighted-average discount rate
6.9 %
As
of March 31, 2022, the maturities of the Company’s future minimum lease payments were as follows:
SCHEDULE
OF FUTURE RENTAL PAYMENTS OF LEASES
Twelve Months Ending March 31,
2022 (remaining nine months)
$ 361
2023
480
2024
496
2025
441
2026
346
Thereafter
541
Total
$ 2,665
401(k)
Plan
The
Company has a defined contribution employee benefit plan under section 401(k) of the Code (the “401(k) Plan”). The 401(k)
Plan covers all eligible U.S. employees that are entitled to participate at the beginning of the first full quarter following commencement
of employment. The Company matches the entire amount of the employee contributions up to 3% of the participating employee’s compensation, and then 50 %
of employee contributions between 4% and 5% of the participating employee’s compensation.
These matching contributions vest for 100 %
when the matching contributions are made. Total contributions to the 401(k) Plan amounted to $ 0.1
million for the three months ended March
31, 2022 and 2021.
23
NOTE
14 – NET LOSS PER SHARE OF COMMON STOCK
Basic
and diluted net loss per share of Common Stock (“EPS”) is computed by dividing (i) net loss (the “Numerator”),
by (ii) the weighted average number of shares of Common Stock outstanding during the period (the “Denominator”).
The
calculation of diluted EPS is also required to include the dilutive effect, if any, of stock options, unvested restricted stock awards,
convertible debt and Preferred Stock, and other Common Stock equivalents computed using the treasury stock method, in order to compute
the weighted average number of shares outstanding. For the three months ended March 31, 2022 and 2021, all Common Stock equivalents were
antidilutive.
Presented
below are the calculations of the Numerators and the Denominators for basic and diluted EPS (dollars in thousands, except per share amounts):
SCHEDULE OF COMPUTATION OF ANTI-DILUTIVE WEIGHTED-AVERAGE SHARES OUTSTANDING
2022
2021
Calculation of Numerator:
Net loss
$ ( 5,515 )
( 3,399 )
Loss applicable to common stockholders
$ ( 5,515 )
$ ( 3,399 )
Calculation of Denominator:
Weighted average number of shares of Common Stock outstanding
21,233
18,211
Net loss per share of Common Stock (basic and diluted)
$ ( 0.26 )
$ ( 0.19 )
As
of March 31, 2022 and December 31, 2021, the following potential Common Stock equivalents were excluded from the computation of diluted
net loss per share of Common Stock since the impact of inclusion was antidilutive (in thousands):
SCHEDULE OF OUTSTANDING COMMON STOCK SECURITIES NOT INCLUDED IN THE COMPUTATION OF DILUTED NET LOSS PER SHARE
March 31,
December 31,
2022
2021
Common stock warrants
2,636
2,556
Common stock options
2,938
2,851
Total
5,574
5,407
NOTE
15 - FINANCIAL INSTRUMENTS AND SIGNIFICANT CONCENTRATIONS
Fair
Value Measurements
Fair
value is defined as the price that would be received upon sale of an asset or paid to transfer a liability in an orderly transaction
between market participants on the measurement date. When determining fair value, the Company considers the principal or most advantageous
market in which it transacts and considers assumptions that market participants would use when pricing the asset or liability. The Company
applies the following fair value hierarchy, which prioritizes the inputs used to measure fair value into three levels and bases the categorization
within the hierarchy upon the lowest level of input that is available and significant to the measurement of fair value:
Level
1—Quoted prices in active markets for identical assets or liabilities accessible to the reporting entity at the measurement date
Level
2—Other than quoted prices included in Level 1 that are observable for the asset and liability, either directly or indirectly through
market collaboration, for substantially the full term of the asset or liability
24
Level
3—Unobservable inputs for the asset or liability used to measure fair value to the extent that observable inputs are not available,
thereby allowing for situations in which there is little, if any market activity for the asset or liability at measurement date
As
of March 31, 2022 and December, 31 2021, the fair value of the Company’s cash and cash equivalents, accounts receivable, accounts
payable, and accrued liabilities approximated their carrying values due to the short-term nature of these instruments.
Recurring
Fair Value Measurements
For
the three months ended March 31, 2022 and 2021, the Company did not have any recurring measurements for the fair value of assets and
liabilities.
The
Company’s policy is to recognize asset or liability transfers among Level 1, Level 2 and Level 3 as of the actual date of the events
or change in circumstances that caused the transfer. During the three months ended March 31, 2022 and 2021, the Company had no transfers
of its assets or liabilities between levels of the fair value hierarchy.
Significant
Concentrations
Financial
instruments that subject the Company to concentrations of credit risk consist primarily of cash, cash equivalents, restricted cash, and
accounts receivable. The Company maintains its cash, cash equivalents and restricted cash at high-quality financial institutions. Cash
deposits, including those held in foreign branches of global banks, may exceed the amount of insurance provided on such deposits. As
of March 31, 2022, the Company had cash and cash equivalents with two financial institutions in the United States with an aggregate balance
of $ 17.8 million. As of March 31, 2021, the Company had cash and cash equivalents with two financial institutions in the United States
with an aggregate balance of $ 14.1 million. The Company has never experienced any losses related to its investments in cash, cash equivalents
and restricted cash.
Generally,
credit risk with respect to accounts receivable is diversified due to the number of entities comprising the Company’s customer
base and their dispersion across different geographies and industries. The Company performs ongoing credit evaluations on certain customers
and generally does not require collateral on accounts receivable. The Company maintains reserves for potential bad debts.
NOTE 16 – SUBSEQUENT EVENTS
On May 9, 2022, the Company collected a tenant
improvement allowance receivable shown on the accompanying balance sheet in full for $ 0.5
million. This allowance was associated with the build out of the Company’s Vivos Institute facility in Denver, Colorado
and was provided by the landlord of such facility.
25
Item
2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
The
following discussion and analysis of our financial condition and results of operations should be read in conjunction with our financial
statements and the related notes to those statements included elsewhere in this Quarterly Report on Form 10-Q. In addition to historical
financial information, the following discussion and analysis contains forward-looking statements that involve risks, uncertainties, and
assumptions. Some of the numbers included herein have been rounded for the convenience of presentation. Our actual results may differ
materially from those anticipated in these forward-looking statements as a result of many factors. See “Cautionary Note Regarding
Forward-Looking Statements.”
Overview
We
are a revenue stage medical technology company focused on the development and commercialization of innovative treatment alternatives
for patients with dentofacial abnormalities and/or patients diagnosed with mild to moderate obstructive sleep apnea (OSA) and snoring
in adults. We believe our technologies and conventions represent a significant improvement in the treatment of mild to moderate OSA versus
other treatments such as continuous positive airway pressure (or CPAP) or palliative oral appliance therapies. Our alternative treatments
are part of The Vivos Method .
The
Vivos Method is an advanced therapeutic protocol, which often combines the use of customized oral appliance specifications and proprietary
clinical treatments developed by our company and prescribed by specially trained dentists in cooperation with their medical colleagues.
Published studies have shown that using our customized appliances and clinical protocols led to significantly lower Apnea Hypopnea Index
scores and improve other conditions associated with OSA. Our patented oral appliances have proven effective (within the scope of the
U.S. Food and Drug Administration (or FDA) cleared uses) in approximately 27,000 patients treated worldwide by more than 1,500 trained
dentists.
Our
business model is focused around dentists, and our program to train independent dentists and offer them other value-added services in
connection with their ordering and use of The Vivos Method for patients is called the Vivos Integrated Practice
(“VIP”) program.
Impact
of COVID-19
In
December 2019, a novel strain of coronavirus known as COVID-19 was reported to have surfaced in China, and by March 2020 the spread of
the virus resulted in a world-wide pandemic. By March 2020, the U.S. economy had been largely shut down by mass quarantines and government
mandated stay-in-place orders (the “Orders”) to halt the spread of the virus. Many of these Orders have been relaxed or lifted
in jurisdictions where large portions of the population have been vaccinated, but there is considerable uncertainty about whether the
Orders will need to be reinstated due to the ongoing spread of new variants of COVID-19. A significant portion of the worldwide population
remains unvaccinated, and uncertainty also exists about whether existing vaccines will be effective as new variants of COVID-19 emerge.
Accordingly, the overall impact of COVID-19 continues to have an adverse impact on global business activities.
Many
of our VIPs and potential VIPs closed their offices during 2020 as a result of COVID-19, although some remained open to specifically
provide patients our products as our appliances and VIPs were deemed an essential business for health considerations in many jurisdictions.
In the face of the pandemic and the results potential for revenue reduction, we worked diligently to reduce expenses and maintain revenues
during 2020. While revenue growth flattened in March and April 2020, expenses were reduced and we aggressively expanded our network of
healthcare providers familiar with our products by offering online continuing education courses which introduced many in the medical
and dental communities to our product line. As businesses continued to reopen through 2021, the impact of COVID-19 on our company began
to diminish, although we continue to closely monitor the potential impact of COVID-19 variants on our business. Of note, during the second
half of 2021, many of our Canadian VIPs have not traveled to the U.S. for training in light of travel restrictions. As of August 9, 2021,
the Government of Canada imposed further restrictions on unvaccinated travelers, which has caused delays with some of our Canadian VIPs
receiving required training and commencing Vivos Method cases.
26
In
addition, our fourth quarter 2021 revenue growth was impacted by lower VIP enrollments due largely to the COVID-19 Omicron variant resurgence.
We achieved sales growth despite seeing significant headwinds throughout our core customer base, mostly driven by COVID-19 Delta and
Omicron variant resurgences in the middle and latter part of the year. In December 2021, the American Dental Association reported that
just 60% of dental practices were open and operating with business as usual. Another industry source reported 92% of dental practices
were struggling to hire or replace hygienists, and 77% reported difficulty hiring front desk positions. These challenges across the dental
community have impacted both VIP enrollments and patient case starts, as replacement dental personnel must be trained in the proper use
of The Vivos Method. The world-wide response to the pandemic resulted in a significant downturn in economic activity, which continued
into 2022 as a new variant (called B.A.2) has emerged, and there remains a risk that new variant outbreaks will cause additional
disruptions and slowdowns in the economy.
As
such, the long-term financial impact on our business of COVID-19 as well as these other matters cannot reasonably be fully estimated
at this time.
Material
Items, Trends and Risks Impacting Our Business
We
believe that the following items and trends may be useful in better understanding our results of operations.
New
VIP Enrollments (Service Revenue). Enrolling denta1 practices as VIPs is the first step in our ability to generate new revenue. As
part of the VIP enrollment fee, we enter into a service contract with VIPs under which they receive training on the use of the Vivos
treatment protocol. VIPs have the ability to start generating revenue for us and themselves after this training. To entice dentists to
enroll as VIPs, we have worked with different marketing programs (which we generally call a “discovery track”) with respect
to the payment of VIPs enrollment fee, including discounts and payment plans. Once VIPs execute their VIP enrollment agreement, the discovery
track allows the VIP 45 to 60 days to obtain financing and pay the enrollment fee. Ongoing support and additional training is provided
throughout the year under the services contract, which includes access to our proprietary Airway Intelligence Services, which provides
the VIP with resources to help simplify the sleep apnea diagnostic and Vivos treatment planning process.
In
addition to enrollment service revenue, we offer additional services, such as our Billing Intelligence Services offering, and MyoCorrect
orofacial myofunctional therapy services, which was introduced in April 2021. Revenue for these services is recognized monthly during
the month the services are rendered.
We
are also engaging in strategic collaborations to market the benefits of the Vivos treatment protocol and VIP enrollment to dentists,
including our cooperative relationships with various medical providers to deliver diagnostic and medical consultation
services to people across North America who suffer from OSA and our October 2021 cross marketing collaboration with Candid Care, the
maker of the CandidPro clear aligner for straightening teeth.
Historically,
we commenced the recognition of VIP enrollment revenue once the contract was signed. Due to some dentists not fulfilling their
obligation, we are now recognizing revenue on VIP enrollments once the contract is executed and payment is received in full.
27
New
VIP Case Starts (Product Revenue). Enrolling new VIPs is key to our ability to generate revenue, but equally as important is the
number of Vivos treatment case starts that our VIPs commence, as these lead to appliance orders and related revenue. Once a VIP is fully
trained, we encourage them to start cases. However, our experience has been that VIPs typically start slowly as they introduce The Vivos
Method into their practices. While we work with VIPs to screen their patients for OSA with our SleepImage home sleep apnea ring test
(which we expect will encourage Vivos Method case starts), not all VIPs incorporate our The Vivos Method into their practices at the
same rate. We utilize Practice Advisors to help VIPs with onboarding and starting and increasing case starts over time. We believe VIPs
can recoup their investment in VIP enrollment with approximately eight Vivos Method case starts, but as noted above, many VIPs start
and also maintain their case starts at a significantly slower rate. We presently have a concentration of active VIPs who regularly start
new Vivos Method treatment cases, with approximately thirty-six percent (36%) of VIPs accounting for all new case starts
during the quarter ended March 31, 2022. We are working not only to increase the number of VIPs overall, but the number
of active VIPs in terms of case starts. More active VIPs are also more likely to take advantage of our other service revenue generating
offerings such as MyoCorrect orofacial myofunctional therapy and medical Billing Intelligence Services.
Marketing
to DSOs . During the second half of 2021, we increased our efforts to market The Vivos Method and related products and services to
larger dental support organizations (“DSOs”). Marketing to DSOs creates an opportunity to enroll and onboard multiple
dental practices as VIPs under one common ownership structure. This would allow us to leverage training and support across multiple VIP
practices and gain economies of scale with the goal of faster growth, both in VIP enrollments and in Vivos case starts. Our other dentist
enrollment program, which we refer to as the Airway Alliance Program (“AAP”), was also established in the fourth quarter
of 2021 and launched in the first quarter of 2022. This program is designed to attract the vast majority of the estimated 200,000 U.S.
and Canadian dentists who are being strongly encouraged by the American Dental Association to screen their patients for sleep apnea.
The AAP gives these dentists the simple yet profitable way to screen their patients for mild to moderate OSA using the SleepImage home
sleep test. Patients with mild to moderate OSA can be referred to a fully trained local VIP dentist for treatment.
Inflation .
We believe the U.S. has entered a period of inflation which has increased (and may continue to increase) our and our
suppliers’ costs as well as the end cost of our products to consumers. To date, we have been able to manage inflation risk
without a material adverse impact on our business or results of operations. However, inflationary pressures (including increases
in the price of raw material components of our appliances) made it necessary for us to adjust our standard pricing for our
appliance products effective May 1, 2022. The full impact of such price adjustments on sales or demand for our products is
not fully known at this time and may require us to adjust other aspects of our business as we seek to grow revenue and, ultimately,
achieve profitability and positive cash flow from operations.
Supply
Chain. From time to time, we may experience supply chain challenges due to forces beyond our control. For example, the Suez Canal
blockage earlier in 2021 caused some delay in shipments of SleepImage rings from China. Overall, however, as our appliances are made
in the U.S., we have not experienced significant supply chain issues as a result of COVID-19 or otherwise, although this may change in
future periods.
Seasonality .
We believe that the patient volumes of our VIPs will be sensitive to seasonal fluctuations in urgent care and primary care activity.
Typically, winter months see a higher occurrence of influenza, bronchitis, pneumonia and similar illnesses; however, the timing and severity
of these outbreaks vary dramatically. Additionally, as consumers shift toward high deductible insurance plans, they are responsible for
a greater percentage of their bill, particularly in the early months of the year before other healthcare spending has occurred, which
may lead to lower than expected patient volume or an increase in bad debt expense during that period. Our quarterly operating results
may fluctuate significantly in the future depending on these and other factors.
Cybersecurity .
We have established procedures to escalate enterprise level issues, including cybersecurity matters, to the appropriate management levels
within our organization and our board of directors, or members or committees thereof, as appropriate. Under our framework, cybersecurity
issues, including those involving vulnerabilities introduced by our use of third-party software, are analyzed by subject matter experts
for potential financial, operational, and reputational risks, based on, among other factors, the nature of the matter and breadth of
impact. Matters determined to present potential material impacts to our financial results, operations, and/or reputation are immediately
reported by management to the board of directors, or individual members of committees thereof, as appropriate, in accordance with our
escalation framework. In addition, we have established procedures to ensure that members of management responsible for overseeing the
effectiveness of disclosure controls are informed in a timely manner of known cybersecurity risks and incidents that may materially impact
our operations and that timely public disclosure is made, as appropriate.
28
War
in Ukraine. In addition, worldwide supply chain constraints and economic and capital markets uncertainty arising out of Russia’s
invasion of Ukraine in February 2022 have emerged as new barriers to long-term economic recovery. If an economic recession or depression
commences and is sustained, it could have a material adverse effect on our business as demand for our products could decrease. Capital
markets uncertainty, with public stock price decreases and volatility, could make it more difficult for us to raise needed capital at
the appropriate time.
Key
Components of Consolidated Statements of Operations
Net
revenue. We recognize revenue when we satisfy our performance obligations over time as our customer receive the benefit of training
and/or we transfer control of the promised products to our customers, which generally occurs over a very short period of time. Performance
obligations are typically satisfied by shipping or delivering products to customers, or customers receiving training, which is also the
point when title transfers and/or training occurs. Revenue consists of the gross sales price, net of estimated allowances, discounts,
and personal rebates that are accounted for as a reduction from the gross sale price.
Cost
of sales. Cost of goods sold primarily consists of direct costs attributable to the purchase from third party suppliers and related
products. It also includes freight costs, fulfillment, distribution, and warehousing costs related to products sold.
Sales
and marketing. Sales and marketing costs primarily consist of personnel costs for employees engaged in sales and marketing activities,
commissions, advertising and marketing costs, website enhancements, and conferences for our sales
and marketing staff.
General
and administrative expenses. General and administrative (“G&A”) expenses consist primarily of personnel costs
for our administrative, human resources, finance and accounting employees, and executives. General and administrative expenses also include
contract labor and consulting costs, travel - related expenses, legal, auditing and other professional fees, rent and facilities
costs, repairs and maintenance, and general corporate expenses.
Depreciation
and amortization expense. Depreciation and amortization expense is comprised of depreciation expense related to property and
equipment, amortization expense related to leasehold improvements, and amortization expense related to identifiable intangible assets.
Other
income. Other income relates to the PPP loan forgiven in January 2022 by the SBA.
29
Results
of Operations
Comparison
of the three months ended March 31, 2022 and 2021
Our
unaudited consolidated statements of operations for the three months ended March 31, 2022 and 2021 are presented below (dollars in thousands):
2022
2021
Change
Revenue
Product revenue
$ 1,722
$ 1,387
$ 335
Service revenue
1,738
2,061
(323 )
Total revenue
3,460
3,448
12
Cost of sales (exclusive of depreciation and amortization shown
separately below)
1,093
758
350
Gross profit
2,367
2,690
(338 )
Gross profit %
68 %
78 %
Operating expenses
General and administrative
8,275
5,059
3,215
Sales and marketing
753
860
(107 )
Depreciation and amortization
162
177
(15 )
Operating loss
(6,823 )
(3,406 )
(3,431 )
Non-operating income (expense)
Other expense
(38 )
(1 )
(37 )
PPP loan forgiveness
1,287
-
1,287
Other income
59
8
51
Net loss
$ (5,515 )
$ (3,399 )
$ (2,130 )
Revenue
Revenue
increased by less than $0.1 million, to $3.5 million for the three months ended March 31, 2022 compared to $3.4 million for the
three months ended March 31, 2021. Revenue during the first quarter of the year remained constant due to an increase of approximately
$0.2 million attributable to higher appliance sales to VIPs, (ii) an increase of approximately $0.1 million in revenue from our two company-owned
dental centers, (iii) and an increase of approximately $0.3 million in BIS revenue and myofunctional therapy service revenue, offset
by a decrease of approximately $0.5 million in VIP enrollment revenue.
During
the three months ended March 31, 2022, we enrolled 32 VIPs and recognized VIP revenue of approximately $1.2 million,
a decrease of 29% compared to the three months ended March 31, 2021, when we enrolled 53 VIPs for a total of approximately
$1.7 million. R evenue growth was impacted by the COVID-19
Delta and Omicron variant resurgences towards the end of 2021 and through the first quarter of 2022. In December 2021, the American
Dental Association reported that just 60% of dental practices were open and operating with business as usual. Another industry source
reported 92% of dental practices were struggling to hire or replace hygienists, and 77% reported difficulty hiring front desk positions.
These challenges across the dental community have impacted both doctor enrollments and patient case starts, as replacement dental personnel
must be trained in The Vivos Method.
For
the three months ended March 31, 2022, we sold 2,965 oral appliance arches for a total of approximately $1.5 million, a 19% increase
from the three months ended March 31, 2021 when we sold 2,570 total oral appliance arches for a total of approximately $1.3 million.
Lastly, for the three months ended March 31, 2022 we had approximately $0.2 million in center revenue, compared to approximately $0.1
million for the three months ended March 31, 2021, and approximately $0.2 million in our orofacial myofunctional therapy revenue, compared
to almost none for the three months ended March 31, 2021 due to the introduction of these services late in the first quarter of 2021.
Cost
of Sales and Gross Profit
Cost
of sales increased by approximately $0.3 million to approximately $1.1 million for the three months ended March 31, 2022 compared to
approximately $0.8 million for the three months ended March 31, 2021. This increase was primarily due to product and services costs associated
with higher sales volume of our appliances, additional costs associated with VIP enrollments, and billing and myofunctional therapy revenue.
Cost of sales includes approximately $0.2 million related to costs associated with appliances and approximately $0.1 million increase
related to our new program (started in 2022) related to the sale and leasing of SleepImage rings.
30
For
the three months ended March 31, 2022, gross profit decreased by approximately $0.3 million to $2.4 million. This decrease was attributable
to an increase in cost of sales of $0.3 million. Gross margin decreased to 68% for the three months ended March 31, 2022 compared to
78% for the three months ended March 31, 2021, primarily driven by the higher costs associated with appliances due to increase in
cost of raw materials and VIP enrollments due to new incentives deployed to increase VIP enrollments.
General
and Administrative Expenses
General
and administrative expenses increased approximately $3.2 million, or approximately 64%, to approximately $8.3 million for the three months
ended March 31, 2022, as compared to $5.1 million for the three months ended March 31, 2021. The primary driver of this increase was
an increase in personnel and related compensation of approximately $1.3 million, including salaries, bonuses, paid time off, stock-based
compensation, and other employee-related expenses. The increase in payroll related costs were mainly a result of increased headcount
(from 110 employees at March 31, 2021 to 165 employees at March 31, 2022). Other drivers of the increase in general and administrative
expenses included an increase of approximately $0.8 million to general corporate costs such as director and officer insurance premiums
and professional fees, an increase of approximately $0.5 million for information and technology supplies and equipment, as well as corporate
expenses such as filing fees, subscriptions, and office expenses. These increases were due to the growth of the company combined with
higher headcount and expenses associated with being a public company.
Sales
and Marketing
Sales
and marketing expense decreased by $0.1 million to $0.8 million for the three months ended March 31, 2022, compared to $0.9 million for
the three months ended March 31, 2021. This decrease was primarily due to a decrease in sales commissions of approximately $0.3 million,
offset by an increase of approximately $0.2 million in new marketing campaigns, updating marketing materials for investors and consumers,
improving the Vivos website. The main driver to the decrease in commissions is due to the decrease in VIP enrollments.
Depreciation
and Amortization
Depreciation
and amortization expense was approximately $0.2 million for the three months ended March 31, 2022 and 2021. The insignificant change
in depreciation expense is related to new assets placed into service which was offset by lower depreciation expense related to legacy
assets that were retired during the year.
PPP
Loan Forgiveness
PPP
loan forgiveness is approximately $1.3 million for the three months ended March 31, 2022 when compared to none for the three months ended
March 31, 2021. The increase is due to the PPP loan being forgiven by the SBA in its entirety.
Liquidity
and Capital Resources
As
of March 31, 2022, we had cash and cash equivalents of $17.8 million compared to cash and cash equivalents of $14.1 million as of March
31, 2021. This increase was primarily driven by the net proceeds from our May 2021 underwritten follow-on offering, partially offset
by increased spending during 2021 and first quarter of 2022.
While
we have incurred losses and negative operating cash flows since inception, we believe that our existing cash resources following our
May 2021 follow-on offering will be sufficient to meet our capital requirements and fund our planned operations through at least the
first quarter of 2023, although this estimation assumes we do not face unexpected events, costs, or contingencies, any of which could
affect our liquidity and cash requirements. Available resources may be consumed more rapidly than anticipated, resulting in the need
for additional funding if we do not generate positive cash flows from operations. If and when required, we anticipate funding our liquidity
requirements from cash generated from operations and potentially from:
●
proceeds
from public and private financings (including equity (such as an “at the market offering” program), debt or equity-linked
financings or commercial debt facilities);
31
●
proceeds
from the exercise of outstanding options or warrants; and
●
strategic
commercial transactions with third parties.
There
is a risk that none of these plans will be implemented if and when necessary or on commercially reasonable terms, if at all, which could
leave us without required cash resources and could adversely impact our results of operations and impair the viability of our company.
We
do not have any off-balance sheet arrangements, as defined by applicable regulations of the SEC, that are reasonably likely to have a
current or future material effect on our financial condition, results of operations, liquidity, capital expenditures or capital resources.
Cash
Flows
The
following table presents a summary of our cash flow for the three months ended March 31, 2022 and 2021 (in thousands):
2022
2021
Net cash provided by (used in):
Operating activities
$ (6,082 )
$ (3,861 )
Investing activities
(120 )
(262 )
Financing activities
-
(25 )
Net
cash used in operating activities of approximately $6.1 million for the three months ended March 31, 2022 is an increase of more than
$2.2 million compared to net cash used in operating activities of approximately $3.9 million for the three months ended March 31, 2021.
This increase is due primarily to the increase in our net loss of approximately $3.0 million, offset by a decrease of approximately $1.4
million in accounts payable, an increase of approximately $0.4 million in accounts receivable related to a decrease in VIP enrollments,
and a decrease of approximately $0.3 million in accrued expenses due to increase in consulting fees, legal fees, third party lab fees
associated with the production of our appliances, an increase of approximately $0.1 million in prepaid expenses and current assets primarily
driven by annual renewals of subscriptions and other paid services, and an increase of approximately $1.3 attributable to PPP loan forgiveness
on January 21, 2022.
For
the three months ended March 31, 2022, net cash used in investing activities consisted of capital expenditures for property and equipment
of $0.1 million. Capital expenditures for property and equipment were primarily attributable to leasehold improvements for The Vivos
Institute that opened in August 2021.
For
the three months ended March 31, 2022, there was no cash used in financing activities.
Critical
Accounting Policies Involving Management Estimates and Assumptions
Our
critical accounting policies and estimates are described in “Management’s Discussion and Analysis of Financial Condition
and Results of Operations—Critical Accounting Policies and Estimates” in our Annual Report on Form 10-K for the fiscal year
ended December 31, 2021. We have reviewed and determined that those critical accounting policies and estimates remain our critical accounting
policies and estimates as of and for the three months ended March 31, 2022.
32
Recent
Accounting Pronouncements
From
time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board or other standard setting bodies that
are adopted by us as of the specified effective date. Unless otherwise discussed in Note 1 to our consolidated financial statements included
in Item 8 of this Report, we believe that the impact of recently issued standards that are not yet effective could have a material impact
on our financial position or results of operations upon adoption. For additional information on recently issued accounting standards
and our plans for adoption of those standards, please refer to the section titled Recent Accounting Pronouncements under Note
1 to our consolidated financial statements included in Item 8 of this Report.
Item
3. Quantitative and Qualitative Disclosures About Market Risk
Trade
Policy Risk. Certain of our products or components are manufactured outside the United States. Most products imported into the United
States is subject to duty and restrictive quotas on the amount of products that can be imported from certain countries into the United
States each year. Because of the duty rates and quotas, changes in U.S. trade policy as reflected in various legislation, trade preference
programs and trade agreements have the potential to materially impact our sourcing strategy and the competitiveness of its contract manufacturers.
We manage this risk by continually monitoring U.S. trade policy, analyzing the impact of changes in such policy and adjusting its manufacturing
and sourcing strategy accordingly.
Foreign
Currency Risk. We receive United States dollars for all of our product sales. Currently, all inventory purchases from our non-U.S.
contract manufacturers are also denominated in United States dollars; however, should we make purchases in foreign currencies in the
future, purchase prices for our products may be impacted by fluctuations in the exchange rate between the United States dollar, which
may have the effect of increasing our cost of goods in the future.
Commodity
Price Risk. We are subject to commodity price risk arising from price fluctuations in the market prices of sourced titanium and steel
products or the various raw materials components of its manufactured products. We are subject to commodity price risk to the extent that
any fluctuations in the market prices of its purchased titanium and steel products and raw materials are not reflected by adjustments
in selling prices of its products or if such adjustments significantly trail changes in these costs. We neither enter into significant
long-term sales contracts nor enter into significant long-term purchase contracts. We do not engage in hedging activities with respect
to such risk .
Credit
Risk. Credit risk relates to the risk of loss resulting from non-performance or non-payment by counterparties pursuant to the terms
of their contractual obligations. Risks surrounding counterparty performance and credit could ultimately impact the amount and timing
of expected cash flows. Certain financial instruments potentially subject our company to a concentration of credit risk. These financial
instruments consist primarily of cash and cash equivalents and accounts and vendor receivables. We place our cash and cash equivalents
with high-credit, quality financial institutions. The balances in these accounts exceed the amounts insured by the Federal Deposit Insurance
Corporation.
Item
4. Controls and Procedures.
Evaluation
of Disclosure Controls and Procedures
Our
disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e)) are designed to ensure that information required to
be disclosed by us in reports we file or submit under the Securities Exchange Act of 1934, as amended, is recorded, processed, summarized
and reported within the appropriate time periods, and that such information is accumulated and communicated to our Chief Executive Officer
and Chief Financial Officer, as appropriate, to allow timely discussions regarding required disclosure. As of the end of the period covered
by this quarterly report, we, under the supervision of and with the participation of our management, including our Chief Executive Officer
and Chief Financial Officer, have evaluated the effectiveness of our disclosure controls and procedures. Based on that evaluation, our
Chief Executive Officer and Chief Financial Officer concluded that the design and operation of our disclosure controls and procedures
were not effective because of our previously reported material weakness in our internal control over financial reporting, which we describe
in Part II, Item 9A of our Annual Report on Form 10-K for the year ended December 31, 2021 (the “2021 Form 10-K”).
33
Remediation
of Material Weakness
We
are committed to maintaining a strong internal control environment and implementing measures designed to help ensure that significant
deficiencies contributing to the material weakness are remediated as soon as possible. We believe we have made progress towards remediation
and continue to implement our remediation plan for the previously reported material weakness in internal control over financial reporting,
described in Part II, Item 9A of our 2021 Form 10-K, which includes steps to increase dedicated personnel, improve reporting processes,
design and implement new controls, and enhance related supporting technology. We will consider the material weakness remediated after
the applicable controls operate for a sufficient period of time, and management has concluded, through testing, that the controls are
operating effectively.
Changes
in Internal Control over Financial Reporting
As
outlined above, due to the identification of the material weakness , we continue to strengthen our internal control structure by
adding accounting staff, adjusting segregation of duties, adding additional levels of review, and adding technical support. We made no
other changes in internal control over financial reporting, as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act, during
the quarter ended March 31, 2022 that has materially affected, or is reasonably likely to materially affect, our internal control over
financial reporting.
PART
II – OTHER INFORMATION
Item
1. Legal Proceedings.
For
a discussion of our legal proceedings, see the information in Part I, “Part I, Item 3. Legal Proceedings” in our Annual Report
on Form 10-K for the fiscal year ended December 31, 2021. There have been no material changes to the legal proceedings disclosed in our
Annual Report on Form 10-K for the fiscal year ended December 31, 2021.
From
time to time, we are involved in various claims and legal actions arising in the ordinary course of business. Other than the items disclosed
in our Annual Report Form 10-K for the fiscal year ended December 31, 2021 in Part I, “Part I, Item 3, Legal Proceedings,”
there are no other legal proceedings currently pending against us, or known to be contemplated by any governmental agency, which we believe
would have a material effect on our business, financial position or results of operations.
On
April 13, 2021, the Washington State Department of Financial Institutions (“WSDFI”) sent a letter and subpoena requesting
that we produce certain documents and records. WSDFI is investigating certain sales of our common stock by a previous employee and independent
contractor in Washington prior to our initial public offering. This subject matter in general (including activities of such previous
employee and independent contractor) had been among the issues previously investigated by a joint committee of our board of directors
and internal and external legal counsel that commenced in February 2020 and, pursuant to the findings and recommendations of the joint
committee, led to the company implementing in April 2020 certain enhanced corporate governance policies (in the form of a formal written
policy on private stock sales requiring prior approval of our internal or external legal counsel and changes to certain organizational
matters). We have cooperated with WSDFI regarding this investigation, but during and subsequent to the year ended December 31, 2021,
we have not been made aware of any developments with the investigation.
On
June 5, 2020, we filed suit against Ortho-Tain, Inc.(“Ortho-Tain”) in the United States District Court for the District of
Colorado seeking relief from certain false, threatening, and defamatory statements to our business affiliate, Benco Dental (“Benco”).
We believe such statements have interfered with our business relationship and contract, causing harm to our reputation, loss of goodwill,
and unspecified monetary damages. On February 12, 2021, we amended our complaint to add claims for false advertising and unfair business
practices, as well as additional variants of the original claims to address Ortho-Tain’s alleged false advertising campaign against
us in the fall of 2020. Our amended complaint seeks permanent injunctive relief to prevent what we believe are defamatory statements
and interference with our business relationships by Ortho-Tain. We further seek declaratory relief to refute the defendant’s false
allegations, as well as monetary damages. Prior to filing suit, we worked collaboratively with legal counsel at Benco to address and
resolve this matter. Such efforts were unsuccessful. On February 26, 2021, Ortho-Tain, Inc. filed a motion to dismiss the amended complaint.
We opposed the motion. On September 3, 2021, the District Court denied the motion to dismiss on all grounds and lifted the stay of discovery.
On September 7, 2021, Ortho-Tain filed a notice of appeal of the District Court’s order to the United States Court of Appeals for
the Tenth Circuit. On September 21, 2021, we filed a motion to dismiss the appeal for lack of jurisdiction. On October 12, 2021, the
Court of Appeals referred the motion to dismiss the appeal to the merits panel for decision along with the merits. The appeal is now
fully briefed and awaiting decision form the Tenth Circuit.
34
On
July 22, 2020 Ortho-Tain, Inc. filed a complaint in the United States District Court for the Northern District of Illinois naming our
company, along with our Chairman and Chief Executive Officer, R. Kirk Huntsman, Benco Dental Supply Co., Dr. Brian Kraft, Dr. Ben Miraglia,
and Dr. Mark Musso (the “Illinois Ortho-Tain Case”). The complaint in the Illinois Ortho-Tain Case addresses the same events
as the suit we filed against Ortho-Tain, Inc. in June 2020 as described above. The complaint in the Illinois Ortho-Tain Case alleges
violation of the Lanham Act and an alleged civil conspiracy among the defendants to violate the Lanham Act by an alleged false designation
of origin related to a presentation given by Dr. Brian Kraft at an event sponsored by us and Benco Dental. Ortho-Tain also alleges that
the actions of the defendants, including our company, diverted sales from Ortho-Tain, deprived Ortho-Tain of advertising value and resulted
in a loss of goodwill to Ortho-Tain. Ortho-Tain also alleges two separate breach of contract actions against Dr. Brian Kraft and Mr.
Huntsman. Ortho-Tain’s allegation of breach of contract against Mr. Huntsman, relates to a Non-Disclosure Agreement entered into
in October 2013 with Mr. Huntsman’s prior entity, Xenith Practices, LLC, which Non-Disclosure Agreement expired pursuant to its
terms in October 2016. We continue to evaluate the allegations, although we believe they lack merit and think Ortho-Tain will be unable
to establish actionable damages. On September 9, 2020, we moved to dismiss the claims against us in the Illinois Ortho-Tain Case. On
October 23, 2020, we filed a motion requesting, in the alternative, that if the case is not dismissed, it be transferred to the Colorado
action described above or stayed. On May 14, 2021, the Court granted our motion to stay the Illinois Ortho-Tain Case, pending resolution
of the Colorado action described above. On September 3, 2021 on December 2, 2021, and on April 4, 2022, the Court extended the
stay. The case remains stayed.
On
May 17, 2021, plaintiff Steven Rospond (“Rospond”) filed a lawsuit against Proceed Finance asserting claims for breach of
contract and violation of the Kansas Consumer Protection Act against Defendants Proceed Finance and Security First Bank regarding a $50,000
loan Rospond took to pay for services provided by our company. Rospond sent us a subpoena seeking various documents relating to the services
provided by us to which it responded and provided documents on December 21, 2021. In an Order dated October 26, 2021, the court granted
Rospond an extension of up to seven days after we delivered documents to Rospond within which to amend his lawsuit, including to assert
claims against us. To date, we have no knowledge of Rospond asserting any claims against us. According to the court’s docket, this
lawsuit is still pending and has not been dismissed.
There
are no other legal proceedings currently pending against us, or known to be contemplated by any governmental agency, which we believe
would have a material effect on our business, financial position or results of operations.
Item
1A. Risk Factors
Not
applicable to smaller reporting companies.
Item
2. Unregistered Sales of Equity Securities and Use of Proceeds
None.
Item
3. Default Upon Senior Securities
None.
Item
4. Mine Safety Disclosures
Not
applicable.
Item
5. Other Information
None.
35
Item
6. Exhibits, Financial Statement Schedules.
The
following documents are filed as exhibits to this Quarterly Report on Form 10-Q.
Exhibit
No.
Exhibit
Description
31.1
Certification of the Chief Executive Officer pursuant to Rule 13a-14(a) under the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. (*)
31.2
Certification of the Chief Financial Officer pursuant to Rule 13a-14(a) under the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. (*)
32.1
Certification of the Chief Executive Officer pursuant to Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. (*)#
32.2
Certification of the Chief Financial Officer pursuant to Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. (*)#
101.INS*
Inline
XBRL Instance Document
101.SCH*
Inline
XBRL Taxonomy Extension Schema
101.CAL*
Inline
XBRL Taxonomy Extension Calculation Linkbase
101.DEF*
Inline
XBRL Taxonomy Extension Definition Linkbase
101.LAB*
Inline
XBRL Taxonomy Extension Label Linkbase
101.PRE*
Inline
XBRL Taxonomy Extension Presentation Linkbase
104
Cover
Page Interactive Data File (embedded within the Inline XBRL document)
*
Filed
herewith
#
A
signed original of this written statement required by Section 906 has been provided to the Company and will be retained by the Company
and furnished to the Securities and Exchange Commission or its staff upon request.
36
SIGNATURES
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, thereunto duly authorized.
Vivos
Therapeutics, Inc.
Date:
May
16, 2022
By:
/s/
R. Kirk Huntsman
R.
Kirk Huntsman
Chairman
of the Board and Chief Executive Officer
(principal
executive officer)
Date:
May
16, 2022
By:
/s/
Bradford Amman
Bradford
Amman
Chief
Financial Officer and Secretary
(principal
accounting officer)
37
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.