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, 2024
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.)
7921
Southpark Plaza , Suite 210 ,
Littleton ,
CO
80120
(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”, or “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 ☒
The
registrant had 3,227,270 shares
of its common stock, $0.0001 par value per share, outstanding as of May 13, 2024.
TABLE
OF CONTENTS
Page
Cautionary Note Regarding Forward-Looking Statements
3
PART
I.
FINANCIAL INFORMATION
4
Item
1.
Condensed Consolidated Financial Statements (Unaudited)
4
Condensed Consolidated Balance Sheets as of March 31, 2024 and December 31, 2023
4
Condensed Consolidated Statements of Operations for the three months ended March 31, 2024 and 2023
5
Condensed Consolidated Statements of Stockholder’s Equity as of March 31, 2024 and 2023
6
Condensed Consolidated Statements of Cash Flows for the three months ended March 31, 2024 and 2023
7
Notes to the Condensed Consolidated Financial Statements
8
Item
2.
Management’s Discussion and Analysis of Financial Condition and Results of Operations
31
Item
3.
Quantitative and Qualitative Disclosures About Market Risk
40
Item
4.
Controls and Procedures
41
PART
II.
OTHER INFORMATION
42
Item
1.
Legal Proceedings
42
Item
1A.
Risk Factors
43
Item
2.
Unregistered Sales of Equity Securities and Use of Proceeds
43
Item
3.
Defaults Upon Senior Securities
44
Item
4.
Mine Safety Disclosures
44
Item
5.
Other Information
44
Item
6.
Exhibits, Financial Statement Schedules
44
Signatures
45
2
CAUTIONARY
NOTE REGARDING FORWARD-LOOKING STATEMENTS
This
Quarterly Report on Form 10-Q (this “Report”) contains “forward-looking statements” (as defined in Section
27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended) that reflect our
current expectations and views of future events. The forward-looking statements are contained principally in the section entitled “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 this Report and our other public filings, 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, including our proprietary oral appliances,
as a treatment for dentofacial abnormalities and/or mild to severe 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;
●
our
ability to properly train VIPs in the use of The Vivos Method inclusive of the services we offer independent dentists 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, SleepImage ® home sleep apnea test, arrangements
with durable medical equipment companies (“DMEs”) and other third-party collaborations;
●
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 (“FDA”) and non-U.S. equivalent regulatory
bodies as well as laws, rules and regulations related to the practice of medicine or dentistry;
●
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 outbreaks of disease such as COVID-19, inflation and
volatile geopolitical and capital markets) which could impair our operations, financial performance and ability to raise new capital.
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 “Management’s
Discussion and Analysis of Financial Condition and Results of Operations” “Business” and other sections in this Report as well as the “Risk Factors” section of our Annual Report
on Form 10-K for the fiscal year ended December 31, 2023 and our other public filings. You should thoroughly read this Report 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 Report relate only to events or information as of the date on which the
statements are made in this Report. 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 Report and
the documents that we refer to in this Report and have filed as exhibits to this Report and our other public filings,
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
Condensed Consolidated Balance Sheets
(In
Thousands, Except Per Share Amounts)
March 31, 2024
December 31, 2023
Current assets
Cash and cash equivalents
$ 2,611
$ 1,643
Accounts receivable, net of allowance of $ 252 and $ 250 , respectively
525
202
Prepaid expenses and other current assets
475
616
Total current assets
3,611
2,461
Long-term assets
Goodwill
2,843
2,843
Property and equipment, net
3,332
3,314
Operating lease right-of-use asset
1,302
1,385
Intangible assets, net
408
420
Deposits and other
308
307
Total assets
$ 11,804
$ 10,730
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities
Accounts payable
$ 2,499
$ 2,145
Accrued expenses
2,466
2,334
Current portion of contract liabilities
2,398
2,138
Current portion of operating lease liability
483
474
Other current liabilities
224
198
Total current liabilities
8,070
7,289
Long-term liabilities
Contract liabilities, net of current portion
533
289
Employee retention credit liability
1,220
1,220
Operating lease liability, net of current portion
1,399
1,521
Total liabilities
11,222
10,319
Commitments and contingencies (Note 12)
-
-
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 2,731,270
shares as of March 31, 2024 and 1,833,877
shares as of December 31, 2023
-
-
Additional paid-in capital
97,396
93,462
Accumulated deficit
( 96,814 )
( 93,051 )
Total stockholders’ equity
582
411
Total liabilities and stockholders’ equity
$ 11,804
$ 10,730
The
accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
4
VIVOS
THERAPEUTICS INC.
Unaudited
Condensed Consolidated Statements of Operations
(In
Thousands, Except Per Share Amounts)
2024
2023
Three Months Ended March 31,
2024
2023
Revenue
Product revenue
$ 1,674
$ 1,772
Service revenue
1,745
2,085
Total revenue
3,419
3,857
Cost of sales (exclusive of depreciation and amortization shown separately below)
1,482
1,520
Gross profit
1,937
2,337
Operating expenses
General and administrative
4,921
6,537
Sales and marketing
655
630
Depreciation and amortization
146
175
Total operating expenses
5,722
7,342
Operating loss
( 3,785 )
( 5,005 )
Non-operating income (expense)
Other expense
( 1 )
51
Excess warrant fair value
-
( 6,453 )
Change in fair value of warrant liability, net of issuance costs of $ 645
-
9,628
Other income
23
76
Loss before income taxes
( 3,763 )
( 1,703 )
Net loss
$ ( 3,763 )
$ ( 1,703 )
Net loss per share (basic and diluted)
$ ( 1.63 )
$ ( 1.72 )
Weighted average number of shares of Common Stock outstanding (basic and diluted)
2,308,154
990,669
The
accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
5
VIVOS
THERAPEUTICS INC.
Unaudited
Condensed Consolidated Statements of Stockholders’ Equity (Deficit)
(In
Thousands, Except Common Stock Amounts)
Shares
Amount
Capital
Deficit
Total
Three Months Ended March 31, 2023 and 2024
Additional
Common Stock
Paid-in
Accumulated
Shares
Amount
Capital
Deficit
Total
Balances, December 31, 2022
920,592
$ -
$ 84,269
$ ( 79,468 )
$ 4,801
Issuance of common stock in private placement, net of issuance costs
80,000
-
-
-
-
Issuance of common stock for purchase of assets
10,000
-
116
-
116
Issuance of commons stock upon exercise of warrants
186,666
-
2,848
-
2,848
Issuance of warrants to consultants for services
-
-
625
-
625
Stock-based compensation expense
-
-
306
-
306
Net loss
-
-
-
( 1,703 )
( 1,703 )
Balances, March 31, 2023
1,197,258
$ -
$ 88,164
$ ( 81,171 )
$ 6,993
Balances, December 31, 2023
1,833,877
$ -
$ 93,462
$ ( 93,051 )
$ 411
Balance
1,833,877
$ -
$ 93,462
$ ( 93,051 )
$ 411
Issuance of commons stock upon exercise of warrants, net of issuance costs
897,393
-
3,635
-
3,635
Issuance of warrants to consultants for services
-
-
6
-
6
Stock-based compensation expense
-
-
293
-
293
Net loss
-
-
-
( 3,763 )
( 3,763 )
Balances, March 31, 2024
2,731,270
$ -
$ 97,396
$ ( 96,814 )
$ 582
Balance
$ 2,731,270
$ -
$ 97,396
$ ( 96,814 )
$ 582
The
accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
6
VIVOS
THERAPEUTICS INC.
Unaudited
Condensed Consolidated Statements of Cash Flows
(In
Thousands)
2024
2023
Three Months Ended March 31,
2024
2023
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss
$ ( 3,763 )
$ ( 1,703 )
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation expense
293
306
Depreciation and amortization
146
175
Fair value of warrants issued for services
6
625
Change in fair value of warrant liability, net of issuance costs of $ 645
-
( 9,628 )
Excess warrant fair value
-
6,453
Changes in operating assets and liabilities:
Accounts receivable
( 324 )
136
Prepaid expenses and other current assets
141
102
Operating lease liabilities, net
( 30 )
( 25 )
Deposits
4
79
Accounts payable
354
84
Accrued expenses
132
28
Other liabilities
21
( 31 )
Contract liability
504
( 140 )
Net cash used in operating activities
( 2,516 )
( 3,539 )
CASH FLOWS FROM INVESTING ACTIVITIES:
Acquisitions of property and equipment
( 151 )
( 239 )
Payment for asset purchase
-
( 50 )
Net cash used in investing activities
( 151 )
( 289 )
CASH FLOWS FROM FINANCING ACTIVITIES:
Proceeds from exercise of pre-funded warrants
3,941
8,000
Payments for issuance costs
( 306 )
( 645 )
Net cash provided by financing activities
3,635
7,355
Net increase in cash and cash equivalents
968
3,527
Cash and cash equivalents at beginning of year
1,643
3,519
Cash and cash equivalents at end of year
$ 2,611
$ 7,046
SUPPLEMENTAL DISCLOSURE OF NON-CASH INVESTING AND FINANCING
ACTIVITIES:
Fair value of warrants issued in asset purchase
$ -
$ 116
The
accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
7
VIVOS
THERAPEUTICS INC.
Notes
to Unaudited Condensed Consolidated Financial Statements
For
the Three Months Ended March 31, 2024 and 2023
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., a Texas corporation (“First Vivos”), and Vivos Therapeutics, Inc., a Wyoming corporation
(“Vivos”), which was established on July 7, 2016 to facilitate SEA transaction. Pursuant to the SEA, all of the outstanding shares of common stock and warrants of BioModeling and all of the
shares of common stock of First Vivos were exchanged for newly issued shares of 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.
Reverse
Stock Split
On
October 25, 2023, the Company effected a reverse stock split of its outstanding shares of common stock at a ratio of 1-for-25 (the
“Reverse Stock Split”). The Reverse Stock Split, which was approved by the Company’s Board of Directors under
authority granted by the Company’s stockholders at the Company’s 2023 Annual Meeting of Stockholders held on September
22, 2023, was consummated pursuant to a Certificate of Amendment filed with the Secretary of State of Delaware on October 25, 2023
(the “Certificate of Amendment”). Unless the context otherwise requires, all references in the accompanying financial
statements, these footnotes to the financial statements in general to shares of the Company’s common stock, including prices
per share of the common stock, reflect the Reverse Stock Split. Fractional shares were not issued, and the final number of shares
were rounded up to the next whole share.
Description
of Business
We
are a medical technology and services company that features a comprehensive suite of proprietary oral appliances and therapeutic
treatments. Our products non-surgically treat certain maxillofacial and developmental abnormalities of the mouth and jaws that are
closely associated with breathing and sleep disorders such as mild to severe obstructive sleep apnea (“OSA”) and snoring
in adults. The Company offers three separate clinical pathways or programs to providers—Guided Growth and Development,
Lifeline, and Complete Airway Repositioning and Expansion (“CARE”). Each program features certain oral appliances
coupled with specific therapeutic treatments, and each clinical pathway is intended to address the specific needs of a diverse
patient population with different patient needs. For example, the Guided Growth and Development program features the Vivos Guide and
PE x appliances along with adjunctive, non-Company therapies used by a dentist (such as CO 2 laser treatments
and other therapies) designed for treating palatal growth (growth of the mouth roof) and expansion in pediatric patients as they
grow. The mid-range priced Lifeline program features a selection of mandibular advancement devices (“MADs”) such as the
Versa and Vida Sleep which are FDA 510(k) cleared for mild-to-moderate OSA in adults, along with the patented Vida appliance, which
is FDA 510(k) cleared as unspecified classification for the alleviation of Temporomandibular Joint Dysfunction (“TMD”)
symptoms, bruxism, migraine headaches, and nasal dilation.
8
The
Company’s flagship CARE program, which is part of The Vivos Method, features the Company’s patented DNA, mRNA and mmRNA appliances,
which are also FDA 510(k) cleared for mild-to-severe OSA and snoring in adults. The Vivos Method may also include adjunctive myofunctional,
chiropractic/physical therapy, and laser treatments that, when properly used with the CARE appliances, constitute a powerful non-invasive
and cost-effective means of reducing or eliminating OSA symptoms. In a small subset of a study, the data has actually shown that The
Vivos Method can reverse OSA symptoms in a large portion (up to 80 %) of patients. The primary competitive advantage of The Vivos Method
over other OSA therapies is that The Vivos Method’s typical course of treatment is limited in most cases to 12 to 15 months, and
it is possible not to need lifetime intervention, unlike CPAP and neuro-stimulation implants. Additionally, out of over 42,600 patients
treated to date worldwide with the Company’s entire current suite of products, there have been very few instances of relapse.
The
Company also offers a suite of diagnostic and support products and services to dental and medical providers and distributors who
treat patients with OSA or related conditions. Such products and services include (i) VivoScore home sleep screenings and tests
(powered by SleepImage ® technology), (ii) AireO2 (an electronic health record program designed specifically for use
by dentists treating sleep patients), (iii) Treatment Navigator (a concierge service to assist a provider in educating and
supporting the doctors as they navigate insurance coverage, diagnostic indications and treatment options), (iv) Billing Intelligence
Services (“BIS”) (which optimizes medical and dental reimbursement), (v) advanced training and continuing education
courses at the Company’s Vivos Institute in Denver, Colorado, (vi) MyoCorrect, a service through which Vivos-trained providers
can provide orofacial myofunctional therapy (“OMT”) to patients via a telemedicine platform, and (vii) the
Company’s Medical Integration Division (“MID”), which manages independent medical practices under management and
development agreements which pays the Company from six ( 6 %)
to eight ( 8 %)
percent of all net revenue from sleep-related services as well as development fees.
The
Company’s business model is to teach, train, and support dentists, medical doctors, and distributors in the use of the Company’s
products and services. Dentists who use the Company’s products and services typically enroll in a variety of live or online training
and educational programs offered through the Company’s Vivos Institute—an 18,000 sq. ft. facility located near the Denver
International Airport. Dentists are able to select the specific program or clinical pathway that they want to focus on, such as Guided
Growth and Development or Lifeline or both. Dentists may also enroll in the VIP program for the complete set training, educational, and support
services available in all three clinical pathway programs. Dentists enrolled in the VIP Program are referred to as “VIPs.”
The Company charges upfront enrollment fees to educate and train new providers. The Company also charges for the ancillary support services
listed above and views each product and service as a revenue/profit center.
Basis
of Presentation and Consolidation
The
Company’s unaudited condensed consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting
principles (“GAAP”). Any reference in these notes to applicable guidance is meant to refer to the authoritative GAAP as found
in the Accounting Standards Codification (“ASC”) and Accounting Standards Updates (“ASU”) of the Financial Accounting
Standards Board (“FASB”).
In
the opinion of management, the accompanying unaudited condensed consolidated financial statements include all adjustments, consisting
of normal recurring adjustments, which are necessary to present fairly the Company’s financial position, results of operations,
and cash flows. The condensed consolidated balance sheet at December 31, 2023 has been derived from audited financial statements at that
date. The interim results of operations are not necessarily indicative of the results that may occur for the full fiscal year. Certain
information and footnote disclosure normally included in the financial statements prepared in accordance with GAAP have been condensed
or omitted pursuant to instructions, rules, and regulations prescribed by the United States Securities and Exchange Commission (“SEC”).
The
Company believes that the disclosures provided herein are adequate to make the information presented not misleading when these unaudited
condensed consolidated financial statements are read in conjunction with the December 31, 2023 audited consolidated financial statements
contained in the Company’s 2023 Annual Report on Form 10-K, which was filed with the Securities and Exchange Commission on March
28, 2024.
9
Emerging
Growth Company Status
The
Company is an “emerging growth company” (an “EGC”), 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 as a result, the Company may take advantage of certain
exemptions from various reporting requirements that are applicable to other public companies that are not EGCs. These include, but are
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.
Further,
Section 102(b)(1) of the JOBS Act exempts EGCs 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-EGC but any such election to opt out is irrevocable. The Company currently
expects to retain its status as an EGC 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. A significant majority of the Company’s revenues are generated
from enrolling dentists as either (i) Guided Growth and Development VIPs; (ii) Lifeline VIPs; (iii) combined Guided Growth and Development
and Lifeline VIPs; or Premier Vivos Integrated Providers (“Premier VIPs”). Prior to the second quarter of 2023, the majority of VIP enrollments
were Premier VIPs. The other, lower priced enrollments were piloted in prior fiscal quarters on a limited basis. They were officially
adopted during the second quarter of 2023. For each VIP program, revenue is recognized when control of the products or services is transferred
to customers (i.e., VIP dentists ordering such products or services for their patients) in a manner that reflects the consideration the
Company expects to be entitled to in exchange for those products and services.
Following
the guidance of ASC Topic 606, Revenue from Contracts with Customers (“ASC 606”) and the applicable provisions of
ASC Topic 842 , Leases (“ASC 842”), 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
VIP
Enrollment Revenue
The
Company reviews its VIP enrollment contracts from a revenue recognition perspective using the 5-step method outlined above. All program
enrollees, irrespective of their level of enrollment, are commonly referred to as VIPs, unless it is necessary to specify their particular
program. Once it is determined that a contract exists (i.e., a VIP enrollment agreement is executed and payment is received), service
revenue related to VIP enrollments is recognized when the underlying services are performed. The price of the Premier VIP enrollment
that the VIP pays upon execution of the contract is significant, running at approximately $ 26,200 , with different entry levels for the
various programs described above. Unearned revenue reported on the balance sheet as contract liability represents the portion of fees
paid by VIP 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. Accordingly, the contract liability for unearned revenue is a
significant liability for the Company. Provisions for discounts are provided in the same period that the related revenue from the products
and/or services is recorded.
10
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 (now known as the Premier VIP Program) which includes training in a highly personalized,
deep immersion workshop format which provides the Premier VIP dentist access to a team who is dedicated to creating a successful integrated
practice.
VIP
enrollment fees include multiple performance obligations which vary on a contract-by-contract basis. The performance obligations included
with enrollments may include sleep apnea rings, a six or twelve month BIS subscription, a marketing package, lab credits and the right
to sell our appliances. The Company allocates the transaction price of a VIP enrollment contract to each performance obligation under
such contract using the relative standalone selling price method. The relative standalone price method is based on the proportion of
the standalone selling price of each performance obligation to the sum of the total standalone selling prices of all the performance
obligations in the contract.
The
right to sell is similar to a license of intellectual property because without it the VIP cannot purchase appliances from the Company.
The right to sell performance obligation includes the Vivos training and enrollment materials which prepare dentists for treating their
patients using The Vivos Method.
Because
the right to sell is never sold outside of VIP contracts, and VIP contracts are sold for varying prices, the Company believes that it
is appropriate to estimate the standalone selling price of this performance obligation using the residual method. As such, the observable
prices of other performance obligations under a VIP contract will be deducted from the contract price, with the residual being allocated
to the right to sell performance obligation.
The
Company uses significant judgements in revenue recognition including an estimation of customer life over which it recognizes the right
to sell. The Company has determined that Premier VIPs who do not complete sessions 1 and 2 of training rarely complete training at all
and fail to participate in the Premier VIP program long term. Since the beginning of the Premier VIP program, just under one-third of
new VIP members fall into this category, and the revenue allocated to the right to sell for those VIPs is accelerated at the time in
which it becomes remote that a VIP will continue in the program. Revenue is recognized in accordance with each individual performance
obligation unless it becomes remote the VIP will continue, at which time the remainder of revenue is accelerated and recognized in the
following month. Those VIPs who complete training typically remain active for a much longer period, and revenue from the right to sell
for those VIPs is recognized over the estimated period of which those VIPs will remain active. Because of various factors occurring year
to year, the Company has estimated customer life for each year a contract is initiated. The estimated customer lives are calculated separately
for each year and have been estimated at 15 months for 2020, 14 months for 2021, 18 months for 2022, 23 months for 2023, and 27 months
in 2024, as a result of customers staying active for longer periods of time. The right to sell is recognized on a sum of the years’
digits method over the estimated customer life for each year as this approximates the rate of decline in VIPs purchasing behaviors we
have observed.
Other
Service Revenue
In
addition to VIP enrollment service revenue, in 2020 the Company launched BIS, an additional service on a monthly subscription basis,
which includes the Company’s AireO2 medical billing and practice management software. Revenue for these services is recognized
monthly during the month the services are rendered.
The
Company also offers its VIPs the ability to provide MyoCorrect to the VIP’s patients as part of treatment with The Vivos Method.
The program includes packages of treatment sessions that are sold to the VIPs and resold to their patients. Revenue for MyoCorrect services
is recognized over the 12-month performance period as therapy sessions occur.
11
Allocation
of Revenue to Performance Obligations
The
Company identifies all goods and services that are delivered separately under a sales arrangement and allocates revenue to each performance
obligation based on relative fair values. These fair values approximate the prices for the relevant performance obligation that would
be charged if those services were sold separately, and are recognized over the relevant service period of each performance obligation.
After allocation to the performance obligations, any remainder is allocated to the right to sell under the residual method and is recognized
over the estimated customer life. In general, revenues are separated between durable medical equipment (product revenue) and education
and training services (service revenue).
Treatment
of Discounts and Promotions
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 SleepImage ® home sleep test program, or a free
trial period for the SleepImage ® 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 line of oral devices and preformed guides
(known as appliances or systems) to its customers, the VIP dentists. These include the DNA appliance ® , mRNA
appliance ® , the mmRNA appliance, the Versa, the Vida, the Vida Sleep and others. The Company expanded its product
offerings in the first quarter of 2023 via the acquisition of certain U.S. and international patents, product rights, and other
miscellaneous intellectual property from Advanced Facialdontics, LLC, a New York limited liability company (“AFD”).
Revenue from appliance sales is recognized when the control of a product is transferred to the VIP in an amount that reflects the
consideration it expects to be entitled to in exchange for those products. The VIP in turn charges the VIP’s patient and or
patient’s insurance a fee for the appliance and for his or her professional services in measuring, fitting, and installing the
appliance and educating the patient as to its use. The Company contracts with VIPs for the sale of the appliance and is not involved
in the sale of the products and services from the VIP to the VIP’s patient.
The
Company’s appliances are similar to a retainer that is worn in the mouth after braces are removed. Each appliance is unique
and is fitted to the patient. The Company utilizes its network of certified VIPs throughout the United States and in some non-U.S.
jurisdictions (notably Canada and Australia) to sell the appliances to their customers as well as in two dental centers that the
Company operates. The Company utilizes third party contract manufacturers or labs to produce its patient-customized, patented appliances and
its preformed guides. The manufacturer designated by the Company produces the appliance in strict adherence to the Company’s
patents, design files, treatments, processes and procedures and under the direction and specific instruction of the Company, ships
the appliance to the VIP 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 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 VIP the contracted price for the appliance which is recorded
as product revenue. Product revenue is recognized once the appliance ships to the VIP under the direction of the Company.
12
In
support of the VIPs using the Company’s appliances for their patients, the Company utilizes a team of trained technicians 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 Company owned centers than for revenue from
VIPs. 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 certain dentists (known as Clinical Advisors) discounts to standard VIP pricing. This is done to help encourage
Clinical Advisors, who help the VIPs with technical aspects of the Company’s products, to purchase Company products for their
own practices. In addition, from time to time, the Company offers credits to incentivize VIPs to adopt the Company’s products
and increase case volume within their practices. These incentives are recorded as a liability at issuance and are deducted from the
related product sale at the time the credit is used.
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, the determination of customer life and breakage related to recognizing revenue for VIP
contracts, impairment of goodwill and long-lived assets; valuation assumptions for assets acquired in asset acquisitions; valuation
assumptions for stock options, warrants, warrant liabilities and equity instruments issued for goods or services; deferred income taxes and the related
valuation allowances; and the evaluation and measurement of contingencies. 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
Accounts
receivable represent amounts due from customers in the ordinary course of business and are recorded at the invoiced amount and do not
bear interest. Accounts receivable are stated at the net amount expected to be collected, using an expected credit loss methodology to
determine the allowance for expected credit losses. The Company evaluates the collectability of its accounts receivable and determines
the appropriate allowance for expected credit losses based on a combination of factors, including the aging of the receivables, historical
collection trends, and charge-offs. When the Company is aware of a customer’s inability to meet its financial obligation, the Company
may individually evaluate the related receivable to determine the allowance for expected credit losses. The Company uses specific criteria
to determine uncollectible receivables to be charged-off, including bankruptcy filings, the referral of customer accounts to outside
parties for collection, and the length that accounts remain past due.
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 3 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 assets are placed in service.
13
Intangible
Assets, Net
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 as of December 31. There were no quantitative or qualitative indicators
of impairment that occurred for the year ended December 31, 2023, and for the three months ended March 31, 2024, accordingly no impairment
was required.
Intangible
assets consist of assets acquired from First Vivos and costs paid to (i) MyoCorrect, from whom the Company acquired certain assets related
to its OMT service in March 2021, (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 and (iii) AFD,
from whom the Company acquired certain U.S. and international patents, trademarks, product rights, and other miscellaneous intellectual
property in March 2023. 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,
Lyon Dental and AFD for patents and intellectual property are amortized over the life of the underlying patents, which approximates 15
years.
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. There were no quantitative or qualitative
indicators of impairment that occurred for the year ended December 31, 2023, and for the three months ended March 31, 2024, accordingly
no impairment was required.
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 an expense in the period when it is determined that an offering is unsuccessful.
14
Employee
Retention Tax Credit
The
employee retention tax credit (“ERTC”) for 2020 was established under the Coronavirus Aid, Relief, and Economic Security
Act of 2020 (the “CARES Act”) and amended by the Taxpayer Certainty and Disaster Tax Relief Act of 2020 (the “Relief
Act”). The ERTC provided for changes in the employee retention credit for 2020 and provided an additional credit for the first,
second and third calendar quarters of 2021. Employers are eligible for the credit if they experienced either a full or partial suspension
of operations during any calendar quarter because of governmental orders due to the COVID-19 pandemic or if they experienced a significant
decline in gross receipts based on a comparison of quarterly revenue results for 2020 and/or 2021 and the corresponding quarters in 2019.
The ERTC is a refundable credit that employers can claim on qualified wages paid to employees, including certain health insurance costs.
According
to the Internal Revenue Service (“IRS”) Notice 2021-20, “Guidance on the Employee Retention Credit under Section 2301
of the Coronavirus Aid, Relief, and Economic Security Act,” the period during which there is a significant decline in gross receipts
is determined by identifying the first quarter in 2020 in which the gross receipts are less than 50 % of its gross receipts for the same
period in 2019. The employee retention credit is available only to eligible employers. Section 2301(c)(2)(A) of the CARES Act defines
the term “eligible employer” as any employer carrying on a trade or business during calendar year 2020, and, with respect
to any calendar quarter, for which (1) the operation of the trade or business carried on during calendar year 2020 is fully or partially
suspended due to orders from an appropriate governmental authority limiting commerce, travel, or group meetings (for commercial, social,
religious, or other purposes) due to COVID-19, or (2) such calendar quarter is within the period in which the employer had a significant
decline in gross receipts, as described in section 2301(c)(2)(B) of the CARES Act. VIP dentists and potential VIPs were forced to close
their offices during 2020 as a result of COVID-19. Therefore, the Company qualifies as an eligible employer under this under the CARES
Act.
Section
2301(c)(3)(A)(ii) of the CARES Act also provides that if an eligible employer averaged 100 or fewer employees in 2019 (a “small
eligible employer”), qualified wages are those wages paid by the eligible employer with respect to an employee during any period
described in section 2301(c)(2)(A)(ii)(I) of the CARES Act (relating to a calendar quarter for which the operation of a trade or business
is fully or partially suspended due to a governmental order) or during a calendar quarter within the period described in section 2301(c)(2)(A)(ii)(II)
of the CARES Act (relating to a significant decline in gross receipts). The Company averaged fewer than 80 employees in 2019 and is therefore
considered a small eligible employer under the CARES Act.
Healthcare
plan expenses were not included in the analysis, although they are eligible if an employee has paid health insurance through their paycheck.
Section 2301(c)(5)(B) of the CARES Act provides that “wages” include amounts paid by an eligible employer to provide and
maintain a group health plan (as defined in section 5000(b)(1) of the Code), but only to the extent that the amounts are excluded from
the gross income of employees by reason of section 106(a) of the Code. The Company pays the first $500 of healthcare insurance for each
employee, which generally covers the monthly cost of their insurance. Because of this, the Company conservatively did not include any
of the cost of insurance in its analysis. Additionally, PPP loan amounts were deducted from the amount of total wages paid before calculating
the qualified ERTC wages. The Company applied for the ERTC using Vivos Therapeutics Inc.’s payroll, which covers 95% of its employees .
As
indicated above, for 2020, companies were eligible for a credit equal to 50 percent of the first ten thousand of qualified wages paid
per employee in the aggregate of each eligible quarter. Therefore, the maximum ERTC for the Company for 2020 is five thousand ($5,000)
per employee. For the second and fourth quarters of 2020, the total eligible credit was limited to approximately $0.5 million .
15
For
2021, the ERTC was 70 %
of the first ten thousand qualified wages paid per employee each quarter. Accordingly, the credit was limited to approximately $ 0.7
million. As there is no authoritative guidance
under U.S. GAAP on accounting for government assistance to for-profit business entities, the Company accounted for the ERTC by analogy
to ASC 450, Contingencies . Accordingly, under ASC 450, entities would treat the ERTCs (whether received in cash or as an
offset to current or future payroll taxes) as if they were gain contingencies. When applying ASC 450-30, entities would not consider
the probability of complying with the terms of the ERC program but, rather, would defer any recognition in the income statement until
all uncertainties are resolved and the income is “realized” or “realizable” (i.e., upon receipt of the funds
or formal notice by the IRS that the company is entitled to such funds). In our case, the Company elected to follow a more conservative
approach and instead of recognizing a receivable for amounts to be received when the amended tax forms were filed in 2022, it was decided
to wait for the notice from IRS and cash was received. As for financial statement presentation, it is believed that either classifying
the amounts as a reduction to payroll tax expense (expense off-set is however contrary to U.S. GAAP) or as other income to be acceptable
with appropriate disclosure of the election made by the company. However, the IRS issued a renewed warning regarding the ERTC on March
7, 2023 urging taxpayers to carefully review the ERTC guidelines. The Company continues to evaluate additional information from the IRS,
and elected to disclose the funds received as a separate line item under long-term liabilities on the balance sheet, until more information
becomes available from the IRS. As a result, as of March 31, 2024, and December 31, 2023, approximately $ 1.2
million is reflected under long-term liabilities.
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 expenses 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
and cancellations in the period that the forfeiture or cancellation occurs, rather than estimating the number of awards that are not
expected to vest in accounting for stock-based compensation.
Research
and Development
Costs
related to research and development are expensed as incurred and include costs associated with the research and development of new
products and enhancements to existing products. Research and development costs incurred were less than $ 0.1
million for the three months ended March 31, 2024 and 2023, respectively. These are recorded on the statement of operations under
general and administrative expense.
16
Leases
Operating
leases are included in operating lease right-of-use (“ROU”) assets, 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.
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 the same are
dilutive.
Warrant
Accounting
The
Company accounts for its warrants and financial instruments as either equity or liabilities based upon the characteristics and provisions
of each instrument, in accordance with ASC 815, Derivatives and Hedging . Warrants classified as equity are recorded at fair value
as of the date of issuance on the Company’s consolidated balance sheets and no further adjustments to their valuation are made.
Warrants classified as liabilities and other financial instruments that require separate accounting as liabilities are recorded on the
Company’s consolidated balance sheets at their fair value on the date of issuance and will be revalued on each subsequent balance
sheet date until such instruments are exercised or expire, with any changes in the fair value between reporting periods recorded as other
income or expense. Management estimates the fair value of these liabilities using the Black-Scholes model and assumptions that are based
on the individual characteristics of the warrants or instruments on the valuation date, as well as assumptions for future financings,
expected volatility, expected life, yield, and risk-free interest rate.
17
Segment
Information
We
manage our business within one reportable segment. The Company’s Chief Executive Officer, who is considered to be the chief operating
decision maker (“CODM”), reviews financial information presented on a consolidated basis, accompanied by information about operations for
purposes of making operating decisions and assessing financial performance.
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.
In
November 2023, the FASB issued ASU No. 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures
(“ASU 2023-07”). The standard requires disclosure of significant segment expenses that are regularly provided to the
CODM and included within each reported measure of segment profit or loss, an amount and description of its composition for other
segment items to reconcile to segment profit or loss, and the title and position of the entity’s CODM. The amendments in this
update also expand the interim segment disclosure requirements. This authoritative guidance will be effective for us in fiscal 2025
for annual periods and in the first quarter of fiscal 2026 for interim periods, with early adoption permitted. We are currently
evaluating the effect of this new guidance on our consolidated financial statements and disclosures.
We
have reviewed and considered all other recent accounting pronouncements that have not yet been adopted and believe there are none that
could potentially have a material impact on our business practices, financial condition, results of operations, or disclosures.
NOTE
2 - LIQUIDITY AND ABILITY TO CONTINUE AS A GOING CONCERN
The
financial statements have been prepared in conformity with generally accepted accounting principles, which contemplate continuation of
the Company as a going concern. The Company has incurred losses since inception, including $ 3.8 and $ 1.7 million for the three months
ended March 31, 2024 and 2023, respectively, resulting in an accumulated deficit of approximately $ 96.8 million as of March 31, 2024.
Net
cash used in operating activities amounted to approximately $ 2.5 and $ 3.5 million for the three months ended March 31, 2024 and 2023,
respectively. As of March 31, 2024, the Company had total liabilities of approximately $ 11.2 million.
As
of March 31, 2024, the Company had approximately $ 2.6
million in cash and cash equivalents, which will not be sufficient to fund operations and strategic objectives over the next twelve
months from the date of the issuance of these financial statements. Without additional financing, these factors raise substantial
doubt regarding the Company’s ability to continue as a going concern.
Until
a state of cash flow positivity is reached, management is reviewing all options to obtain additional financing to fund operations.
This financing is expected to come primarily from the issuance of equity securities in order to sustain operations until the Company
can achieve profitability and positive cash flows, if ever. There can be no assurances, however, that adequate additional funding
will be available on favorable terms, or at all. If such funds are not available in the future, the Company may be required to
delay, significantly modify or terminate some or all of its operations, all of which could have a material adverse effect on the
Company and its stockholders.
The
Company does 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.
18
NOTE
3 - REVENUE, CONTRACT ASSETS AND CONTRACT LIABILITIES
Net
Revenue
For
the three months ended March 31, 2024 and 2023, 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,
2024
2023
Product revenue
Appliances
1,145
1,314
Guides
529
458
Total product revenue
1,674 (1)
1,772
Service revenue
VIP
907
1,294
Billing intelligence services
225 (2)
214
Sleep testing services
307
262
Myofunctional therapy services
184
217
Sponsorship/seminar/other
122
98
Total service revenue
1,745
2,085
Total revenue
$ 3,419
$ 3,857
(1)
Product
revenue from the sale of appliances and guides is typically fixed at the inception of the contract and is recognized at the point in
time when shipment of the related products occurs.
(2)
BIS
revenue from subscription contracts is typically fixed at the inception of the contract and is recognized ratably over time as the
services are performed and the performance obligations completed.
Changes
in Contract Liabilities
The
key components of changes in contract liabilities for the three months ended March 31, 2024 and 2023 are as follows (in thousands):
SCHEDULE
OF CONTRACT LIABILITY
2024
2023
Beginning balance, January 1
$ 3,038
$ 3,038
New contracts, net of cancellations
855
1,225
Revenue recognized
( 962 )
( 1,396 )
Ending balance, March 31
$ 2,931
$ 2,867
Current
portion of deferred revenue is approximately $ 2.4 million, which is expected to be recognized over the next 12 months from the date of
the period presented. Additionally, revenue from breakage on contract liabilities was approximately $ 0.4 and $ 0.3 million for the three
months ended March 31, 2024 and 2023, respectively.
Changes
in Accounts Receivable
Our
customers are billed based on fees agreed upon in each customer contract. Receivables from customers were $ 0.2 million at December 31.
2023, and $ 0.5 million at March 31, 2024. An allowance is maintained for accounts receivable which is generally based on a combination
of factors, including the aging of the receivables, historical collection trends, and charge-offs. Adjustments to the allowance are recorded
in bad debt expense under general and administrative expenses in the consolidated statement of operations. An allowance of $ 0.2 million
existed as of March 31, 2024 and December 31, 2023.
19
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, 2024, and 2023. Shipping costs for product deliveries to customers are included in cost of goods sold in the accompanying consolidated
statement of operations.
NOTE
4 - PROPERTY AND EQUIPMENT, NET
As
of March 31, 2024 and December 31, 2023, property and equipment consist of the following (in thousands):
SCHEDULE
OF PROPERTY AND EQUIPMENT
March 31, 2024
December 31, 2023
Furniture and equipment
$ 1,321
$ 1,321
Leasehold improvements
2,479
2,479
Construction in progress
1,469
1,435
Software
117
-
Molds
405
405
Gross property and equipment
5,791
5,640
Less accumulated depreciation
( 2,459 )
( 2,326 )
Net Property and equipment
$ 3,332
$ 3,314
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. Construction in progress relates to the development of software for internal use expected to be placed in service
in 2024. Total
depreciation and amortization expense was $ 0.1 million and $ 0.2
million for the three months ended March 31, 2024 and 2023, respectively.
NOTE
5 - GOODWILL AND INTANGIBLE ASSETS
Goodwill
Goodwill
of $ 2.8 million as of March 31, 2024 and December 31, 2023, consist of the following acquisitions (in thousands):
SCHEDULE
OF GOODWILL
Acquisitions
March 31, 2024
December 31, 2023
BioModeling
$ 2,619
$ 2,619
Empowered Dental
52
52
Lyon Dental
172
172
Total goodwill
$ 2,843
$ 2,843
20
Intangible
Assets
As
of March 31, 2024 and December 31, 2023, identifiable intangible assets were as follows (in thousands):
SCHEDULE
OF IDENTIFIABLE INTANGIBLES
March 31, 2024
December 31, 2023
Patents and developed technology
$ 2,302
$ 2,302
Trade name
330
330
Other
27
27
Total intangible assets
2,659
2,659
Less accumulated amortization
( 2,251 )
( 2,239 )
Net intangible assets
$ 408
$ 420
Amortization
expense of identifiable intangible assets was less than $ 0.1 million for the three months ended March 31, 2024. 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,
2024 (remaining nine months)
38
2025
50
2026
35
2027
29
2028
29
Thereafter
227
Total
$ 408
NOTE
6 – OTHER FINANCIAL INFORMATION
Accrued
Expenses
As
of March 31, 2024 and December 31, 2023, accrued expenses consist of the following (in thousands):
SCHEDULE OF ACCRUED EXPENSES
March 31, 2024
December 31, 2023
Accrued payroll
$ 1,328
$ 1,498
Accrued legal and other
1,098
798
Lab rebate liabilities and gift cards
40
38
Total accrued liabilities
$ 2,466
$ 2,334
NOTE
7 – PREFERRED STOCK
The
Company’s Board of Directors has the 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, 2024, the Company’s Board of Directors continues to have the authority to designate up
to 50,000,000
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
8 – 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.
21
Common Stock Transactions During the Periods Presented
On
January 9, 2023, the Company closed a private placement (the “January 2023 Private Placement”) pursuant to which the Company
agreed to issue and sell 80,000 shares of Common Stock, Pre-Funded Warrants to purchase up to an aggregate of 186,667 shares of Common
Stock and Common Stock Purchase Warrants to purchase up to an aggregate of 266,667 shares of Common Stock for net proceeds of approximately
$ 7.4 million. Issuance costs associated with the January 2023 Private Placement were approximately $ 0.6 million.
On
February 28, 2023, the Company acquired certain U.S. and international patents, patent applications, trademarks, product rights, and
other miscellaneous intellectual property from AFD. Pursuant to the asset acquisition, the Company agreed to issue 10,000
shares of Common Stock in addition to cash consideration of $ 50,000 .
As a result of this transaction the Company recorded intangible assets of approximately $ 0.2
million. As part of the associated Asset Purchase Agreement, the Company agreed to a future earnout payment consideration based on a
sliding-scale percentage on the volume of future sales, as well as a cash payment of $ 0.2
million upon the achievement of specified milestones. Per the Company’s accounting policy, the contingent consideration
obligation will be recorded as the contingency is resolved and the consideration is paid or becomes payable.
In
addition, the Company entered into an employment agreement with Dr. Scott Simonetti, DDS, the founder and Chief Executive Officer of
AFD, as part-time Senior Director of Research and Development for an annual salary of approximately $ 0.1 million and a five-year warrant
to purchase up to 16,000 shares of Common Stock with an exercise price of $ 15.25 per share; provided, however, that the shares of Common
Stock underlying such warrant are subject to vesting only upon the achievement of specified milestones related to new FDA authorizations
for the intangible assets acquired.
As
disclosed above, on October 25, 2023 (the “Effective Date”), the Company effected a Reverse Stock Split of its
outstanding shares of common stock at a ratio of 1-for-25 .
As of the Effective Date, every twenty-five shares of the Company’s issued and outstanding Common Stock was combined into one
share of Common Stock. As a result, the Company’s issued and outstanding Common Stock on the Effective Date was proportionally
reduced from approximately 29,928,786
shares to approximately 1,197,258 shares.
The ownership percentage of each of the Company’s stockholders remained unchanged, other than as a result of fractional
shares. No fractional shares of Common Stock were issued in connection with the Reverse Stock Split, and stockholders that would
hold a fractional share of Common Stock as a result of the Reverse Stock Split had such fractional shares of Common Stock rounded up
to the nearest whole share of Common Stock. The number of shares of Common Stock available for issuance under the Company’s
equity incentive plans and the Common Stock issuable pursuant to outstanding equity awards and common stock purchase warrants immediately
prior to the Reverse Stock Split were proportionately adjusted by the ratio of the Reverse Stock Split. The exercise prices of such outstanding
options and warrants were also adjusted in accordance with their respective terms. The number of authorized shares of common stock was
not affected by the Reverse Stock Split.
On
November 2, 2023, the Company closed a private placement (the “November 2023 Private Placement”) with an institutional
investor pursuant to which the Company sold an aggregate of $ 4.0
million of securities in a private placement consisting of (i) 130,000
shares of Common Stock, (ii) a pre-funded warrant to purchase 850,393
shares of Common Stock at an exercise price of $ 0.0001
per share, (iii) a five-year Series A Common Stock Purchase Warrant to purchase up to 980,393
shares of Common Stock with an exercise price of $ 3.83
per share and (iii) an 18-month Series B Common Stock Purchase Warrant (the “Series B Warrant”) to purchase up to 980,393
shares of Common Stock with an exercise price of $ 3.83
per share. Issuance costs associated with the November 2023 Private Placement were approximately $ 0.5
million.
In
December 2023, 437,393 of the 850,393 pre-funded warrants granted on November 2, 2023 were exercised. In January 2024, the remaining
413,000 pre-funded warrants were exercised.
On
February 14, 2024, the Company entered into a warrant inducement letter agreement (the “Inducement Agreement”) with the same
institutional investor in the November 2023 Private Placement pursuant to which the investor agreed to exercise for cash the entirety
of the Series B Warrant at an exercise price of $ 4.02 per share (with such exercise price being established for purposes of compliance
with the listing rules of the Nasdaq Stock Market), resulting in gross proceeds to the Company of approximately $ 4.0 million. Pursuant
to the Inducement Agreement, in consideration for the immediate exercise of the Series B Warrant in full, the Company agreed to issue
to the investor, in a new private placement transaction (the “Inducement Transaction”): (i) a 5-year, Series B-1 Common Stock
Purchase Warrant to purchase 735,296 shares of the Company’s common stock at an exercise price of $ 5.05 per share, and (ii) an
18-month, Series B-2 common stock purchase warrant to purchase 735,296 shares of our common stock at an exercise price of $ 5.05 per share
(collectively, the “Inducement Warrants” and such aggregate 1,470,592 shares of the Company’s common stock underlying
the Inducement Warrants, the “Inducement Warrant Shares”). The Inducement Warrants are identical to each other, other than
their dates of expiration, and are substantially identical to the Series B Warrant. Issuance costs associated with the February inducement were approximately $ 0.3 million.
22
NOTE
9 – 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 53,333 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 13,333 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 81,334 shares of Common Stock such that, after
such amendments, and prior to any grants, 94,667 shares of Common Stock were available for issuance.
On
September 22, 2023, stockholders approved an amendment to the Company’s 2019 Plan to increase the number of shares of Company common
stock authorized to be issued pursuant to the 2019 Plan by 80,000 shares from an aggregate of 94,667 shares to an aggregate of 174,667
shares.
During
the three months ended March 31, 2024, and 2023 the Company did not grant stock options to purchase shares of Common Stock. Options
for the purchase of 500
and 500
shares of common stock expired as of March 31, 2024, and 2023. The following table summarizes all stock options from December 31,
2023 to Mach 31, 2024 (shares in thousands):
SCHEDULE OF STOCK OPTIONS
2024
Shares
Price (1)
Term (2)
Outstanding, at December 31, 2023
127
$ 62.45
3.4
Granted
-
-
Forfeited
-
-
Exercised
-
-
Outstanding, at March 31
127 (3)
62.45
3.4
Exercisable, at March 31
93 (4)
70.65
2.7
(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, 2024, the aggregate intrinsic value of stock options outstanding was $ 0 .
(4)
As
of March 31, 2024, the aggregate intrinsic value of exercisable stock options was $ 0 .
23
There
were no stock options granted for the three months ended March 31, 2024. For each of the three months ended March 31, 2024, and 2023
the Company recognized approximately $ 0.3 million of share-based compensation expense relating to the vesting of stock options. Unrecognized
expense relating to these awards as of March 31, 2024 was approximately $ 1.3 million, which will be recognized over the weighted average
remaining term of 3.4 years.
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, 2024 (shares in thousands):
SCHEDULE OF WARRANT OUTSTANDING
2024
Shares
Price
(1)
Term
(2)
Outstanding, at December 31, 2023
2,821
$ 13.15
4.6
Grants of warrants:
Warrant inducement
1,471 (3)
Exercised
( 1,394 ) (4)
Forfeited
( 11 )
Outstanding, at March 31
2,887 (5)
$ 7.83
3.8
Exercisable, at March 31
2,833 (6)
$ 7.60
3.8
(1)
Represents
the weighted average exercise price.
(2)
Represents
the weighted average remaining contractual term until the warrants expire.
(3)
In
February 2024, the Company granted warrants in connection with a warrant inducement consisting of warrants to purchase up to an aggregate
of 1,470,592 shares of common stock at an exercise price of $ 5.05 per share, with a relative fair value of approximately $ 3.9 million
which was recorded to additional paid-in capital at the time of issuance.
(4)
During
the first quarter of 2024, the Company issued an aggregate of 1,393,393 shares of common stock from the exercise of warrants previously
issued in November 2023.
(5)
As
of March 31, 2024, the aggregate intrinsic value of warrants outstanding was $ 0 million.
(6)
As
of March 31, 2024, the aggregate intrinsic value of warrants exercisable was $ 0 million.
For
the three months ended March 31, 2024, 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
2024
Measurement date closing price of Common Stock (1)
$ 5.05
Contractual term (years) (2)
3.1
Risk-free interest rate
4.4 %
Volatility
130 %
Dividend yield
0 %
(1)
Weighted
average grant price.
(2)
The
valuation of warrants is based on the expected term.
24
NOTE
10 - RELATED PARTY TRANSACTIONS
For
the three months ended March 31, 2024 and 2023, no options were granted to the Company’s directors, officers, employees and consultants, and no other related-party transactions occurred.
NOTE
11 - 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, 2024 and 2023 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, 2024 and December 31, 2023 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
12 - COMMITMENTS AND CONTINGENCIES
COVID-19
Pandemic
Our
business was materially impacted by COVID-19 in 2020 and to some extent thereafter and through the early part of 2023 due to the actions
of governmental bodies that mandated quarantines and lockdowns that resulted in many of our VIPs and potential VIPs having to close their
offices. The impact of COVID-19 on our business diminished somewhat as 2023 progressed. However, the residual effects of the pandemic
on dental workforce availability as well as patient precautionary measures continued to negatively impact our VIP dental practices and
our revenue across the U.S. and Canada during 2022 and into 2023. We believe new enrollments during at least the first half of 2023 continued
to be negatively impacted by the ongoing overall workforce uncertainties in the dental market. Thus far in 2024, we do not believe COVID-19
issues are impacting our business in any material way. We continue to monitor the overall landscape of potential viral or other diseases
which may pose a threat, and we will respond appropriately should any such threats materialize.
Inflation,
the War in Ukraine and Middle East Hostilities
The
Company believes that as the U.S. experiences a persistent and protracted 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 may
also increase. In the early part of 2024, there is considerable economic and capital markets uncertainty arising out of several
global factors, including but not limited to, Russia’s ongoing war in Ukraine, the Hamas attacks on Israel in October of 2023,
Israel’s response to those attacks, and social unrest and protests on university campuses have emerged as
new barriers to both near and long-term economic recovery.
25
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. To date, the Company has 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, and we may have to do so again in 2024. 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 seeks to grow revenue and, ultimately, achieve profitability and positive cash flow from operations.
An
additional inflation-related risk is the Federal Reserve’s response, which up to this point has been mainly to raise interest
rates. Such actions have, in times past, created unintended consequences in terms of the impact on housing starts, overall
manufacturing, capital markets, and banking. If such disruptions become systemic, like in the recession of 2008, then the impact on
the Company’s revenue, earnings potential and access to capital of both inflation and inflation-fighting responses would be
impossible to know or calculate.
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’s 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 the purpose 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, Colorado 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 $ 0.3 million in the consolidated balance sheet representing the present value of minimum lease payments using
the Company’s incremental borrowing rate of 6.0 %.
In
May 2018, the Company entered into a commercial lease agreement for 3,643 square feet of office in Highlands Ranch, Colorado 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 $ 0.8 million in the consolidated balance sheet representing the present value of minimum lease payments
using the Company’s incremental borrowing rate of 7.3 %.
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 6.6 %.
In
April 2019, the Company entered into a commercial lease agreement for 3,231 square feet of office in Highlands Ranch, Colorado 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 %.
26
In
April 2019, the Company entered into a commercial lease agreement for 14,732 square feet of office space for its former corporate headquarters
in Denver, Colorado that was to commence on September 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 7.1 %.
In
April 2022, the Company entered into a commercial lease agreement for 8,253 square feet of office space for its corporate headquarters
in Littleton, Colorado that commenced May 16, 2022 and ends on November 15, 2027. As of May 16, 2022, the Company recorded an operating
lease right of use asset and lease liabilities of less than $ 1.5 million in the consolidated balance sheet representing the present value
of minimum lease payments using the Company’s incremental borrowing rate of 10.6 %.
For the three months ended March 31, 2024 and 2023, the components of lease expense are as follows (in thousands):
SCHEDULE OF LEASE EXPENSE
Lease cost:
2024
2023
Operating lease cost
$ 123
$ 130
Total net lease cost
$ 123
$ 130
Rent
expense is recognized on a straight-line basis over the lease term. Lease expense, including real estate taxes and related costs for
the three months ended March 31, 2024 and 2023 aggregated approximately $ 0.1 million in each period. This is included under general and
administrative expense.
As
of March 31, 2024, the remaining lease terms and discount rate used are as follows (in thousands):
SCHEDULE
OF REMAINING LEASE TERMS AND DISCOUNT RATE
2024
Weighted-average remaining lease term (years)
3.5
Weighted-average discount rate
8.4 %
Supplemental
cash flow information related to leases as of March 31, 2024 is as follows (in thousands):
SCHEDULE OF
RELATED TO LEASES
2024
Cash flow classification of lease payments:
Operating cash flows from operating leases
153
As
of March 31, 2024, the maturities of the Company’s future minimum lease payments were as follows (in thousands):
SCHEDULE OF FUTURE MINIMUM LEASE PAYMENTS
As of March 31,
2024 (remaining nine months)
468
2025
594
2026
507
2027
493
2028
133
Thereafter
7
Total lease payments
2,202
Less: Imputed interest
( 320 )
Total
$ 1,882
27
NOTE
13 - 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. As of March 31, 2024 and 2023, 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
2024
2023
For The Three Months Ended March 31,
2024
2023
Calculation of Numerator:
Net loss
$ ( 3,763 )
( 1,703 )
Loss applicable to common stockholders
$ ( 3,763 )
$ ( 1,703 )
Calculation of Denominator:
Weighted average number of shares of Common Stock outstanding
2,308,154
990,669
Net loss per share of Common Stock (basic and diluted)
$ ( 1.63 )
$ ( 1.72 )
As
of March 31, 2024 and 2023, 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, 2024
March 31, 2023
Common stock warrants
2,887
495
Common stock options
127
125
Total
3,014
620
NOTE
14 - 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
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
28
As
of March 31, 2024 and 2023, the fair value of the Company’s cash and cash equivalents, accounts receivable, accounts payable, and
other accrued liabilities approximated their carrying values due to the short-term nature of these instruments.
As
discussed in Note 8, on January 9, 2023, the Company closed on the November 2023 Private Placement for the sale by the Company of
shares of the Company’s common stock and the issuance of pre-funded warrant to purchase up to an aggregate of 186,667
shares of common stock at an exercise price of $ 0.0001
per share, and the issuance of warrant to purchase up to an aggregate of 266,667
shares of common stock at an exercise price of $ 30
per share. The warrants are initially exercisable commencing January 9, 2023 through their expiration date of July 9, 2028. In
addition, as part of the November 2023 Private Placement, we agreed to amend the existing outstanding common stock purchase warrant
held by the purchaser and issued in January 2023 to purchase up to an aggregate of 266,667
shares of Common Stock at an exercise price of $ 30.00
per share with an expiration date of July 5, 2028. Such amendment, which became effective upon the closing of the November 2023
Private Placement, reduced the exercise price of the January warrant to $ 3.83 per
share and extended the expiration date of such warrant to
November 2, 2028 . The amendment also restated in its entirety the definition of “Black Scholes Value” contained
in the January warrant which resulted in the classification of the warrant from liability to equity. The liability associated with
those warrants was initially recorded at fair value in the Company’s consolidated balance sheet upon issuance, and
subsequently re-measured as of March 31, 2023, June 30, 2023, September 30, 2023, and November 2, 2023 when the November 2023
Private Placement closed. The changes in the fair value between issuance, the March 31, 2023 measurement date, the June 30, 2023
measurement date, the September 30, 2023, and the November 2, 2023 measurement date are recorded as a component of other income
(expense), in the consolidated statement of operations.
Recurring
Fair Value Measurements
For
the three months ended March 31, 2024, the Company did not have any assets and liabilities classified as Level 1, Level 2 or Level 3.
The Company concluded that the warrants issued in connection with the private placement, met the definition of a liability under ASC
480, Distinguishing Liabilities from Equity and classified the liability as Level 3. For the three months ended March 31, 2023, the
Company did not have any assets and liabilities classified as Level 1 or Level 2, and had a warranty liability measured at fair value
using significant unobservable inputs (Level 3) of approximately $ 1.3 million.
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, 2024, and 2023 the Company had no transfers
of its assets or liabilities between levels of the fair value hierarchy.
29
Significant
Concentrations
Credit
Risk
Financial
instruments that potentially expose the Company to concentrations of credit risk consist principally of cash and cash equivalents on
deposit with financial institutions, the balances of which frequently exceed federally insured limits. Management monitors the soundness
of these financial institutions and believes the Company’s risk is negligible. The Company has not experienced any losses in such
accounts. If any of the financial institutions with whom the Company does business was to be placed into receivership, the Company may
be unable to access the cash they have on deposit with such institutions. If the Company were unable to access cash and cash equivalents
as needed, the financial position and ability to operate the business could be adversely affected. As of March 31, 2024, the Company
had cash and cash equivalents with three financial institutions in the United States with an aggregate balance of $ 2.6 million.
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. No single customer represented more than 10% of our accounts receivable
as of March 31, 2024. The Company maintains reserves for potential bad debts.
Supplier
Concentration
As
previously disclosed, the Company relies on third-party suppliers and contract manufacturers for the raw materials and components used
in our appliances and to manufacture and assemble our products. As of March 31, 2024, the Company had five suppliers that accounted for
approximately 80 % of the Company’s total purchases during the year. The Company expects to maintain existing relationships with
these vendors.
NOTE
15 – SUBSEQUENT EVENTS
As
previously reported, the Company fell out of compliance with Nasdaq’s $2.5 million minimum stockholders’ equity
requirement (the “Equity Rule”). On November 9, 2023, we presented a plan to Nasdaq outlining our intention to raise
additional equity capital as part of our efforts to regain compliance with the Equity Rule. Subsequently, on November 30, 2023, the
Company received a letter from the Nasdaq hearings panel (the “Hearings Panel”) informing us that the panel had granted
the Company’s request to remain listed on Nasdaq, subject to certain conditions. Such conditions included providing an update
on our compliance plan and demonstrating compliance with the Equity Rule by March 19, 2024.
On
February 23, 2024, we presented our plan of compliance to the Hearings Committee , and on May 6, 2024, Nasdaq confirmed that
the Company had successfully regained compliance with the Equity Rule. Nasdaq will continue to monitor the Company’s ongoing
compliance with the Equity Rule for a one-year period. Failure to demonstrate continued compliance would again subject the Company
to delisting.
30
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 severe obstructive sleep apnea (“OSA”)
and snoring in adults. We believe our technologies and conventions represent a significant improvement in the treatment of mild to severe
OSA versus other treatments such as continuous positive airway pressure (“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 treatments led to significantly lower Apnea Hypopnea Index
scores and have improved other conditions associated with OSA. Over 42,600 patients have been treated to date, worldwide, with our entire
current suite of products by more than 1,950 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.
See
Note 1 to the accompanying financial statements for additional background information on our Company and current product and service
offerings.
Impact
of COVID-19
Our
business was materially impacted by COVID-19 in 2020 and to some extent thereafter and through the early part of 2023 due to the actions
of governmental bodies that mandated quarantines and lockdowns that resulted in many of our VIPs and potential VIPs having to close their
offices. The impact of COVID-19 on our business diminished somewhat as 2023 progressed. However, the residual effects of the pandemic
on dental workforce availability as well as patient precautionary measures continued to negatively impact our VIP dental practices and
our revenue across the U.S. and Canada during 2022 and into 2023. We believe new enrollments during at least the first half of 2023 continued
to be negatively impacted by the ongoing overall workforce uncertainties in the dental market. Thus far in 2024, we do not believe COVID-19
issues are impacting our business in any material way. We continue to monitor the overall landscape of potential viral or other diseases
which may pose a threat, and we will respond appropriately should any such threats materialize.
31
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 dental 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 modalities. 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 as the Company’s
performance obligations are satisfied in accordance with ASC 606.
We
are also engaging in strategic collaborations to market the benefits of the Vivos treatment modalities 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.
We
recognize revenue on VIP enrollments once the contract is executed, payment is received, and as the Company’s performance obligations
are satisfied in accordance with ASC 606.
Product
Sales Revenue. Throughout the latter part of 2023 and into the first quarter of 2024, the Company experienced a decline in Product
Sales Revenue. As previously noted, we believe this decline was due in part to certain adverse events in the larger sleep apnea oral
appliance market, and not specific to Vivos. Another factor contributing to the decline was our Reductions In Force (RIF) which we undertook
during 2022 and 2023. However, those product sales revenue declines only began to reverse somewhat after the end of the first quarter
of 2024. Enrolling new VIPs is key to our ability to generate revenue from product sales, and lower VIP enrollments during 2023 and into
the first quarter of 2024 also dampened product sales revenue. Equally as important, however, is the number of Vivos treatment case starts
that our existing 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 starts 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. Approximately 40% of our VIPs initiated a new case as of March 31, 2024. 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.
32
In
addition, an important aspect of our strategy to increase product revenues relates to the products and related intellectual property
we acquired in March 2023 from Advanced Facialdontics, LLC (“AFD”), including a custom single arch device with an FDA 510(k)
clearance for treating TMD and/or Bruxism (teeth grinding or clenching). We have rebranded the AFD products as Vivos Vida and Vivos Vida
Sleep. During the first quarter of 2024, certain of those products were among the fastest growing segment of our entire product line,
and we fully expect to continue to increase sales of these acquired products throughout the remainder of 2024 and beyond. As described
further below, during 2023 we entered into a distribution agreement with Lincare, a leading durable medical equipment (“DME”),
to distribute certain of our products, including those we acquired from AFD.
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. As of March 31, 2024, we
believe we have made important progress in penetrating this market, but as we cautioned previously, DSOs tend to move slowly when adopting
new technologies or programs, and we do not expect DSO training or product sales to materially impact overall revenue in 2024. 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 a simple yet profitable way to screen their patients for OSA using the SleepImage ® home sleep
test. Patients with OSA can be referred to a fully trained local VIP dentist for treatment. The AAP program did not contribute meaningfully
to revenue in the first quarter of 2024.
Clinical
Trial Work . Our efforts to engage in research to demonstrate the clinical efficacy of our products and obtain additional regulatory
clearances for the use of our products is an important aspect of our overall strategy. In this regard, on May 29, 2023, we and Stanford
University executed an agreement to commence a sponsored clinical research study to evaluate the efficacy of our FDA-cleared DNA appliance
compared to the standard of care, CPAP for treatment of sleep apnea. Our DNA device is currently indicated for the treatment of mild
to severe sleep apnea and jaw repositioning in adults (and in the case of severe OSA, along with positive airway pressure (PAP) and/or
myofunctional therapy, as needed). Enrollment of 150 patients with moderate to severe sleep apnea (apnea-hypopnea index score of 15 or
greater) will be randomly assigned to either treatment with our FDA-cleared DNA appliance or CPAP. The protocol has been finalized and
enrollment began in 2024. This trial may not meet its designated endpoints, and therefore additional FDA clearances for the DNA device
may not be obtained.
Distribution
Agreements. During 2023, we entered into distribution collaborations with third parties to expand access of our products to potential
patients. We hope that these strategic initiatives will lead to revenue growth opportunities for us in 2024 and beyond, and our ability
to capitalize on these initiatives is expected to be a material aspect of our sales and marketing program going forward.
For
example, on June 1, 2023, we entered into a non-exclusive distribution agreement with Lincare, a leading supplier in the United States
of respiratory products, such as CPAP equipment. Lincare currently provides respiratory products to approximately 1.8 million patients
nationwide. Pursuant to this agreement, Lincare began to distribute certain of our products in the United States, including the Vida™,
VidaSleep™, and Versa®. The distribution agreement was subject to a 90-day pilot program in Colorado and Florida. Within weeks
of starting the pilot program, Lincare reported an initial 36% positive patient response to our products subject to the agreement.
33
On
October 24, 2023, we announced the conclusion of this pilot program and an amendment to our Lincare agreement to appoint Lincare as our
exclusive DME distributor in the U.S. for a period of 6-months to distribute the products described above. Since completion of the pilot,
the Lincare roll out has progressed much slower than anticipated, and it is unclear to the Company just what to expect from this relationship
going forward. We no longer expect the Lincare program to materially impact revenue in the near term.
Also,
in October 2023, we announced an exclusive distribution agreement with NOUM DMCC, a Dubai-based company focused on diagnostic testing
and treatment product distribution for healthcare providers and hospital networks treating obstructive sleep apnea patients throughout
the Middle East-North Africa region. Subject to regulatory approvals, which are pending in several countries under the agreement, we
could see revenue from this collaboration in the latter part of 2024.
Impact
on Sales from Unregistered Oral Appliance Publicity. On or about March 1, 2023, CBS News reported the tragic case of a woman with
a malocclusion and breathing problem who had received treatment via a fixed oral appliance known as the AGGA (Anterior Growth Guidance
Appliance). The AGGA is a non-FDA cleared oral appliance developed by Dr. Steve Galella, a dentist from Tennessee. According to the televised
CBS report, the device created serious issues with her dentition and jaws, resulting in the loss of several anterior teeth. The patient
filed a $10 million lawsuit against the treating dentist.
Vivos
was not named in the lawsuit, nor was our device implicated in creating the tooth displacement and other concerns that gave rise to the
lawsuit. Vivos has never had any association or affiliation with the AGGA device or its promoters, nor has the Company ever endorsed
these kind of counterfeit fixed oral appliances that make unproven and unsubstantiated claims.
The
FDA regulates and categorizes all medical devices claiming to treat obstructive sleep apnea (OSA) and/or TMD disorders as Class II devices
and requires that they have a 510(k) clearance in order to be used with patients. The AGGA device does not have any such FDA clearance,
nor are there any known peer-reviewed and published studies validating the safety and efficacy of this device. In stark contrast, all
Vivos oral appliances are duly registered or cleared by the FDA according to strict FDA guidelines. Our appliances and attending protocols
for proper use are also backed by extensive peer reviewed published research. Moreover, Vivos appliances operate on a completely different
mechanism of action than that of the AGGA and similar devices on the market. Vivos has always maintained that such appliances tend to
create inflammation and pose other risks that are unacceptable. The AGGA is a fixed appliance, whereas Vivos appliances are removable
devices.
Unfortunately,
and despite our best efforts to distance ourselves and our products from the AGGA device, the entire matter generated a certain
amount of confusion and fear amongst both existing VIP dentists and other non-affiliated dentist prospects. Thus, new provider
enrollments and sales of Vivos appliances in the first quarter 2023 decreased as word spread. By the latter part of June 2023, we
began to see a partial rebound in new enrollments. Nevertheless, certain Vivos-trained providers remain
very cautious and are being far more selective in their cases, which has continued to impact appliance sales through the end of 2023
and into 2024.
Our
core product is The Vivos Method, not any one single device. We believe this is a key distinguishing factor for our approach. The Vivos
Method involves far more than just our oral appliances. It begins with proper and thorough diagnosis and ends with a customized multidisciplinary
treatment plan that likely incorporates one or more of several treatment modalities, including oral myofunctional therapy, SOT chiropractic,
physical therapy, laser therapy, nutritional counseling, CPAP, mandibular advancement, CARE device therapy, and more. The Vivos Method
is thus a fully integrated end-to-end diagnostic, training, and treatment platform that can adapt to the needs of virtually any and every
breathing disordered sleep patient.
Inflation .
The U.S. has been experiencing 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. In addition, future price adjustments may be required as we seek to grow revenue and, ultimately, achieve profitability
and positive cash flow from operations.
34
An
additional inflation-related risk is the Federal Reserve’s response, which up to this point has been to raise interest rates. Such
actions have, in times past, created unintended consequences in terms of the impact on housing starts, overall manufacturing, capital
markets, and banking. If such disruptions become systemic, as occurred in the recession of 2008, then the impact on our revenue, earnings
and access to capital of both inflation and inflation-fighting responses would be impossible to know or calculate.
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, the fourth quarter tends to be one where we see higher enrollment levels for new VIP dentists, however, as previously mentioned
reported, in the fourth quarter of 2023 we did not see that same pattern emerge. The first and second quarters of each year tend to be
our weakest quarter of the year for new enrollments, and to a certain extent, appliance sales as well. This was the case in the first
half of 2023 and in the first quarter of 2024. 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 in the future depending on these and other factors.
War
in Ukraine and Middle East Hostilities. In addition, worldwide supply chain constraints and
economic and capital markets uncertainty arising out of Russia’s invasion of Ukraine in February 2022 and the attacks by Hamas
on Israel in October of 2023 and Israel’s responses have created much social unrest and protests, disrupted commercial and
capital markets, and 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 capital when
needed.
35
Potential
Nasdaq Delisting. As previously reported, we fell out of compliance with Nasdaq’s $2.5
million minimum stockholders’ equity requirement (the “Equity Rule”) during 2023. On November 9, 2023, we presented
a plan to a Nasdaq Hearings Panel (the “Hearings Panel”) outlining our intention to raise additional equity capital as part
of our efforts to regain compliance with the Equity Rule. Subsequently, on November 30, 2023, we received a letter from the Hearings Panel
informing us that the panel had granted the Company’s request to remain listed on Nasdaq, subject to certain conditions. Such conditions
included providing an update on our compliance plan and demonstrating compliance with the Equity Rule by March 19, 2024.
On February 23, 2024,
we presented an updated plan of compliance to the Hearings Panel, and on May 6, 2024, Nasdaq confirmed that we had successfully regained
compliance with the Equity Rule. Nasdaq will continue to monitor our ongoing compliance with the Equity Rule for a one-year period. Failure
to demonstrate continued compliance would again subject the Company to delisting. This is highly likely given that our stockholder’s
equity as reported in this Report as of March 31, 2024 is less than the $2.5 million required by the Equity Rule. As such, we will likely
receive a delist determination letter from the Nasdaq staff and receive an opportunity to request a new hearing with the Hearings Panel
and present a response. A delisting of our common stock would likely have a significant adverse impact on our stock price, the ability
of our stockholders to trade their common stock, and our overall reputation, thereby posing challenges to the operation of our company.
Key
Components of Consolidated Statements of Operations
Net
revenue. We recognize revenue when we satisfy our performance obligations over time as our customers receive the benefit of the
promised goods and services, which generally occurs over a short period of time. Performance obligations with respect to appliance sales
are typically satisfied by shipping or delivering products to our VIPs or, in the case of enrollment or service revenue, upon our satisfaction
of performance obligations associated with VIP enrollments. 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 interest income in 2024, as well as excess warrant fair value and change in fair value of warrant
liability in 2023.
36
Results
of Operations
Comparison
of the three months ended March 31, 2024 and 2023
Our
consolidated statements of operations for the three months ended March 31, 2024 and 2023 are presented below (dollars in thousands):
Three
Months Ended March 31,
2024
2023
Change
Revenue
Product
revenue
$ 1,674
$ 1,772
$ (98 )
Service
revenue
1,745
2,085
(340 )
Total
revenue
3,419
3,857
(438 )
Cost
of sales (exclusive of depreciation and amortization shown separately below)
1,482
1,520
(38 )
Gross
profit
1,937
2,337
(400 )
Gross
profit %
57 %
61 %
Operating
expenses
General
and administrative
4,921
6,537
(1,616 )
Sales
and marketing
655
630
25
Depreciation
and amortization
146
175
(29 )
Operating
loss
(3,785 )
(5,005 )
1,220
Non-operating
income (expense)
Other
expense
(1 )
51
(52 )
Excess
warrant fair value
-
(6,453 )
6,453
Change
in fair value of warrant liability, net of issuance costs of $645
-
9,628
(9,628 )
Other
income
23
76
(53 )
Net
loss
$ (3,763 )
$ (1,703 )
$ (2,060 )
Revenue
Revenue
decreased approximately $0.4 million, or 11%, to approximately $3.4 million for the three months ended March 31, 2024 compared to
$3.8 million for the three months ended March 31, 2023. Revenue during the first three months of 2024 was impacted by a decrease of
approximately $0.1 million in product revenue due to lower product sales, coupled with a decrease of approximately $0.3 million in
service revenue. The decrease in total revenue is attributable to a decrease of approximately $0.4 million in VIP enrollment revenue
followed by a decrease of approximately $0.2 million in appliance sales to VIPs. This was offset by an increase of approximately
$0.1 million in guides sales to VIPs, and an increase of approximately $0.1 million from sleep testing services and devices. BIS and
Myofunctional therapy revenues remained relatively unchanged at $0.2 million each for the three months ended March 31, 2024 and
2023. Sponsorship and seminar revenue also remained flat at approximately $0.1 million during the same periods.
During
the three months ended March 31, 2024, we enrolled 50 VIPs and recognized VIP enrollment revenue of approximately $0.9 million, a
decrease of 30% in enrollment revenue, compared to the three months ended March 31, 2023, when we enrolled 36 VIPs for a total of
approximately $1.3 million. Revenue growth in the first quarter of 2024 was impacted by updates to key inputs in our revenue
recognition methodology, primarily estimated customer lives. As part of our annual process, the estimated customer lives are
calculated separately for each year and was estimated to be 27 months in 2024, an increase of 17%, compared to 23 months in 2023,
and an even higher increase of 50% when compared to 18 months in 2022. Estimated customer lives impacts the amortization of revenue
to be spread over a longer period of time, thus decreasing the revenue that is recognized over the same period when compared to
2023. Although this negatively impacts our revenue recognition, it is a result of customers staying active for a longer period of
time, thus increasing our customer retention year-over-year. Additionally, our revenue was impacted by new entry levels into the VIP
program, ranging from $2,500 to $50,000 and adding an $8,000 pediatric program, which was received positively by our providers,
however it results in lower revenue per contract. This coupled with lower enrollments during 2023, resulted in lower revenue for
the first quarter of 2024.
37
For
the three months ended March 31, 2024, we sold 1,996 oral appliance arches for a total of approximately $1.7 million, a 6% decrease in
revenue from the three months ended March 31, 2023, when we sold 2,369 oral appliance arches for a total of approximately $1.8 million.
Refer to “Material Items, Trends and Risks Impacting Our Business” section above for events that impacted our product sales.
Cost
of Sales and Gross Profit
Cost
of sales remained relatively constant with a decrease of less than $0.1 million or 3% at approximately $1.5 million for the three months
ended March 31, 2024, compared to slightly over $1.5 million for the three months ended March 31, 2023. This was primarily related to
$0.1 million in lower costs associated with appliances, medical reporting expense, and membership support costs, driven by the lower
sales explained above. This was offset by an increase of approximately less than $0.1 million due to higher costs associated with the
ring lease program and VIP training.
For
the three months ended March 31, 2024, gross profit decreased by approximately $0.4 million to $1.9 million. This decrease was attributable
to a decrease in revenue of approximately $0.4 million offset by a decrease in cost of sales of less than $0.1 million. Gross margin
decreased to 57% for the three months ended March 31, 2024, compared to 61% for the three months ended March 31, 2023 due to the revenue
decrease.
General
and Administrative Expenses
General
and administrative expenses decreased approximately $1.6 million, or approximately 25%, to approximately $4.9 million for the three months
ended March 31, 2024, as compared to $6.5 million for the three months ended March 31, 2023. The primary driver of this decrease was
$0.9 million in professional fees and a change in personnel and related compensation of approximately $0.7 million, including salaries
and benefits, paid time off, stock-based compensation, and other employee-related expenses, as a result of the reduction in force implemented
during the second quarter of 2023. Other drivers of the decrease in general and administrative expenses included a decrease of approximately
$0.2 million related to bad debt expense, and a decrease of approximately $0.1 million related to insurance. This was offset by an increase
of approximately $0.3 million in fees related to being a public company.
Sales
and Marketing
Sales
and marketing expenses remained constant with a slight increase of less than by $0.1 million to $0.7 million for the three months
ended March 31, 2024, compared to slightly over $0.6 million for the three months ended March 31, 2023. This increase was primarily
driven by commissions and digital media and marketing supplies.
Depreciation
and Amortization
Depreciation
and amortization expense was approximately $0.2 million for the three months ended March 31, 2024 and 2023, respectively. Depreciation
and amortization had a slight decrease during the period due to some assets being fully depreciated and an immaterial amount of depreciable
assets placed into service.
Other
Income
Other
income of less than $0.1 million includes immaterial interest income from financial institutions.
Excess
warrant fair value and change in fair value of warrant liability, net of issuance costs
The
liability for the warrants issued in the January 9, 2023 private placement totaled approximately $14.5 million which included 186,667
pre-funded warrants with a fair value of approximately $6.7 million and 266,667 additional common stock purchase warrants with a fair
value of approximately $7.7 million. The difference between the fair value of the $14.5 million liability-classified warrants and the
net proceeds received of approximately $8.0 million, or approximately $6.5 million, was recognized as a day-one non-operating expense.
The change in fair value of the warrant liability was approximately $10.2 million, or $9.6 million of other income net of issuance costs
of $0.6 million, for the three months ended March 31, 2023. The net impact of the private placement warrants for the three months ended
March 31, 2023 was approximately $3.2 million of other income. No warrant liability was recorded in the first quarter of 2024, as such
there is no other income recorded for the three months ended March 31, 2024.
38
Liquidity
and Capital Resources
The
financial statements have been prepared in conformity with generally accepted accounting principles, which contemplate continuation of
the Company as a going concern. The Company has incurred losses since inception, including $3.8 and $1.7 million for the three months
ended March 31, 2024 and 2023, respectively, resulting in an accumulated deficit of approximately $96.8 million as of March 31, 2024.
Net
cash used in operating activities amounted to approximately $2.5 and $3.5 million for the three months ended March 31, 2024 and 2023,
respectively. As of March 31, 2024, the Company had total liabilities of approximately $11.2 million.
As
of March 31, 2024, we had approximately $2.6 million in cash and cash equivalents, which will not be sufficient to fund operations and
strategic objectives over the next twelve months from the date of issuance of these financial statements. Without additional financing,
these factors raise substantial doubt regarding our ability to continue as a going concern. See Note 15 to the financial statements included
in this Report for additional information regarding our financing activity following the three months ended March 31, 2024.
We
previously disclosed that our goal was to decrease costs and increase revenues during 2023 with the aim of becoming cash flow
positive from operations by the first quarter of 2024 without the need for additional financing, if possible. We have successfully
implemented cost savings measures and significantly reduced cash used in operations. However, sales did not grow in 2023 or it the
first quarter of 2024 as anticipated as our product offerings and strategies continue to be refined. As such, we anticipate that we
have raised new financing in late 2023 and early 2024 and will be required to obtain additional financing to satisfy our cash needs
and bolster our stockholders’ equity for Nasdaq compliance purposes, as management continues to work towards increasing revenue to achieve cash flow positive operations in the foreseeable
future.
Until
a state of cash flow positivity is reached, management is reviewing all options to obtain additional financing to fund operations. This
financing is expected to come primarily from the issuance of equity securities in order to sustain operations until we can achieve profitability
and positive cash flows, if ever. There can be no assurances, however, that adequate additional funding will be available on favorable
terms, or at all. If such funds are not available in the future, we may be required to delay, significantly modify or terminate some
or all of our operations, all of which could have a material adverse effect on us and our stockholders.
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, 2024 and 2023 (in thousands):
2024
2023
Net cash provided by (used in):
Operating activities
$ (2,516 )
$ (3,539 )
Investing activities
(151 )
(289 )
Financing activities
3,635
7,355
39
Net
cash used in operating activities of approximately $2.5 million for the three months ended March 31, 2024 is a decrease of approximately
$1.0 million compared to net cash used in operating activities of approximately $3.5 million for the three months ended March 31, 2023.
This decrease is due primarily to the absence of a favorable net change in the fair value of warrant liability of approximately $10.2
million, offset by day-one non-operating warrant expense of approximately $6.5 million, an increase of approximately $0.6 million in
contract liability, an increase of approximately $0.3 million in accounts payable, and an increase of approximately $0.2 million in accrued
expenses and other liabilities. This was offset by an increase in our net loss of approximately $2.0 million, the decrease of approximately
$0.6 million in fair value of warrants issued for services, and an increase of approximately $0.5 million in accounts receivable related
to the DSO clinics and VIP enrollments under payment plans.
For
the three months ended March 31, 2024, net cash used in investing activities consisted of capital expenditures for software of $0.2 million
related to the development of software for internal use expected to be placed in service in 2024. This compares to net cash used in
investing activities for the three months ended March 31, 2023 of $0.3 million due to capital expenditures for internally developed software
and an asset purchase.
Net
cash provided by financing activities of $3.6 million for the three months ended March 31, 2024, is attributable to proceeds of $3.9
million from the issuance of Common Stock, net of approximately $0.3 million of professional fees and other issuance costs, in our February
warrant inducement. This compares to net cash used in investing financing for the three months ended March 31, 2023, of $7.4 million
attributable to proceeds of $8.0 million from the issuance of Common Stock, net of approximately $0.6 million of professional fees and
other issuance costs, from our private placement in January 2023.
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, 2023. 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, 2024.
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 the accompanying condensed consolidated
financial statements included in 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 the accompanying condensed consolidated financial statements included in 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 .
40
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. 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 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, 2023 (the “Form 10-K”).
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 Annual Report on Form 10-K. Our remediation plan, which we implemented in 2023, included: (i) increasing
dedicated personnel and the use of third-party consultants with technical account expertise, (ii) improving our internal reporting processes,
(iii) designing and implementing new controls, and (iv) enhancing our supporting technology. In particular, we believe we have significantly
improved our revenue recognition procedures, our technical accounting capabilities, including with respect to accounting for our outstanding
warrants, and process-level control activities.
As of March 31, 2024, we have taken great strides to complete the full remediation of all of our internal control deficiencies and associated
material weakness by undertaking the plan noted above. We believe that additional review and testing is required in the coming periods
during 2024 before we can affirmatively declare that the material weakness has been fully remediated.
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. We expect to engage in this testing during 2024. However,
we cannot provide assurance that these or other measures will fully remediate our material weaknesses in a timely manner. If our remediation
of these material weaknesses is not effective, it may cause our company to become subject to investigation or sanctions by the SEC. It
may also adversely affect investor confidence in our company and, as a result, the value of our common stock. There can be no assurance
that all existing material weaknesses have been identified, or that additional material weaknesses will not be identified in the future.
Changes
in Internal Control over Financial Reporting
Except
as described above, 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 three months ended March 31, 2024 that has materially affected, or is reasonably likely to materially
affect, our internal control over financial reporting.
41
PART
II – OTHER INFORMATION
Item
1. Legal Proceedings.
From
time to time, we may become involved in various lawsuits and legal proceedings which arise in the ordinary course of business. Below
is a description of our outstanding pending litigation matters. Litigation is subject to inherent uncertainties and an adverse result
in the below described or other matters may arise from time to time that may harm our business.
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 June 21, 2022, the
Tenth Circuit entered an order and judgment. Pursuant to such order, the appeal was terminated, and the case remanded to the U.S.
District Court for the District of Colorado for further proceedings. On July 13, 2022, the Clerk of Court for the Tenth Circuit
transferred jurisdiction back to the District Court. On February 1, 2023, Ortho-Tain filed a motion to re-open the district court
case and set a status conference. On February 22, 2023, Vivos filed a notice of non-opposition joining that request. On July 26,
2023, the District Court reopened the case. On February 14, 2024, the District Court issued an order denying Ortho-Tain’s
motion to dismiss after analyzing the issue of litigation privilege under the standard ordered by the Tenth Circuit. In response,
Ortho-Tain filed a notice of appeal of the District Court’s order on February 14, 2024. The appeal has been docketed in the
Tenth Circuit, and the record has been completed. On March 5, 2024, Vivos filed a motion to dismiss the appeal for lack of
jurisdiction. Ortho-Tain filed its response to the motion to dismiss on March 19, 2024. Vivos’ reply in support of the motion
to dismiss was filed on March 26, 2024. On March 20, 2024, the Court ordered that Vivos’ motion to dismiss for lack of
jurisdiction would be referred to the panel of judges to be assigned to the appeal, and that no ruling on the motion to dismiss
would be issued at that time. Ortho-Tain filed its opening brief on April 29, 2024. Vivos’ Answer Brief is due on or
before May 30, 2024.
On
July 22, 2020 Ortho-Tain filed a Complaint at Law (the “Ortho-Tain Complaint”) in the United States District Court for
the Northern District of Illinois naming Vivos, along with the Company’s Chief Executive Officer, R. Kirk Huntsman, Benco
Dental Supply Co., Dr. Brian Kraft, Dr. Ben Miraglia, and Dr. Mark Musso. The Ortho-Tain Complaint 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 the Company and Benco Dental. Ortho-Tain also alleges that the
actions of the defendants, including the 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 the Company’s Chief Executive Officer, R. Kirk Huntsman. On September 9, 2020, the Company moved to dismiss the
claims against it. On May 14, 2021, the United States District Judge entered an order granting the Company’s motion to stay
this case pending the outcome of a substantially similar, first-filed suit by the Company pending in the United States District
Court for the District of Colorado. In light of the stay, the Court denied, without prejudice, the Company’s pending motion to
dismiss. On September 3, 2021, on December 2, 2021, on April 4, 2022, on July 5, 2022, on September 19, 2022, and on November 22,
2022, the Court extended the stay. On March 2, 2023, the Court lifted the stay.
42
On
April 13, 2023, the Court ordered the parties to exchange Rule 26(a) disclosures by May 1, 2023 and issue initial written discovery by
May 15, 2023. Further, the Court referred the matter to the Magistrate Judge to conduct a settlement conference. On April 28, 2023, the
Court clarified that Dr. Musso’s court ordered participation in settlement and discovery did not waive his objections to personal
jurisdiction and venue, and that Defendants did not need to file a response to the Complaint at this time. On June 2, 2023, the case
was reassigned to the Hon. LaShonda A. Hunt. On July 11, 2023, the Magistrate Judge scheduled a settlement conference for September 1,
2023. On August 1, 2023, Judge Hunt set a deadline to refile motions to dismiss as August 15, 2023, stayed discovery pending resolution
of the motions, and authorized the parties to cancel the settlement conference. The Company filed a motion to dismiss on August 15, 2023,
and a reply brief on October 3, 2023. The Parties are currently awaiting a decision on the motion to dismiss.
On
May 23, 2022, Dr. G. Dave Singh (“Dr. Singh”), the founder and former director and Chief Medical Officer of our company,
through his legal counsel, sent a demand letter (the “Demand Letter”) to us. The Demand Letter asserted certain allegations,
including an assertion that contested our decision to terminate Dr. Singh’s employment for cause in March 2022. As previously disclosed,
on March 1, 2022, with the unanimous approval of our Board of Directors, we provided notice of termination of Dr. Singh’s employment
with our company “for cause” pursuant to the terms Dr. Singh’s amended and restated employment agreement with us (the
“Employment Agreement”). In the Demand Letter, Dr. Singh also asserted certain potential claims against us and/or R. Kirk
Huntsman, our Chairman and Chief Executive Officer, including for breach of contract, breach of fiduciary duty, defamation and other
civil claims and remedies which could include severance payments to Dr. Singh and other money relief if Dr. Singh’s claims are
upheld in arbitration. We believe that Dr. Singh’s assertions completely lack merit in fact or law and further believe that Dr.
Singh will be unable to establish actionable damages. Further, we believe that several provisions of Dr. Singh’s Employment Agreement
limit or restrict claims Dr. Singh is alleging, including a mandatory arbitration clause and exclusive remedy provisions. However, no
assurances can be given that our positions regarding the Demand Letter or the Employment Agreement will be upheld by an arbitrator. The
parties engaged in voluntary mediation, with no resolution reached.
On
November 3, 2022, the Company initiated arbitration with the American Arbitration Association against Dr. Singh. The Company’s
Demand for Arbitration alleged that Dr. Singh’s behaviors and actions constituted a breach of the Employment Agreement as well
as a breach of a fiduciary duty to which he owed the Company, and requests that the Arbitrator declare that Dr. Singh’s sole remedy
or relief against the Company is what was agreed upon in the Employment Agreement. On December 7, 2022, Dr. Singh filed a Cross-Complaint
in the Arbitration alleging claims against the Company for breach of contract, employment discrimination, and violation of the Colorado
Wage Act. On August 18, 2023, the Company filed an Amended Demand for Arbitration to add two claims for breach of contract of the restrictive
covenants for Dr. Singh’s work with Koala Plus and with Stimcore. On January 8, 2024, the Company and Dr. Singh reached a settlement,
and the arbitration has been closed, with the arbitrator maintaining jurisdiction for any issues that may arise from the enforcement
of the settlement agreement.
Item
1A. Risk Factors
Not
applicable to smaller reporting companies.
Item
2. Unregistered Sales of Equity Securities and Use of Proceeds
February
2024 Inducement
On
February 14, 2024, we entered into a warrant inducement letter agreement (the “Inducement Agreement”) with the same institutional
investor in the November 2023 Private Placement pursuant to which the investor agreed to exercise for cash the entirety of the Series
B Warrant at an exercise price of $4.02 per share (with such exercise price being established for purposes of compliance with the listing
rules of the Nasdaq Stock Market), resulting in gross proceeds to the Company of approximately $4.0 million. Pursuant to the Inducement
Agreement, in consideration for the immediate exercise of the Series B Warrant in full, we agreed to issue to the investor, in a new
private placement transaction (the “Inducement Transaction”): (i) a 5-year, Series B-1 Common Stock Purchase Warrant to purchase
735,296 shares of our common stock at an exercise price of $5.05 per share, and (ii) an 18-month, Series B-2 common stock purchase warrant
to purchase 735,296 shares of our common stock at an exercise price of $5.05 per share (collectively, the “Inducement Warrants”
and such aggregate 1,470,592 shares of Common Stock underlying the Inducement Warrants, the “Inducement Warrant Shares”).
The Inducement Warrants are identical to each other, other than their dates of expiration, and are substantially identical to the Series
B Warrant.
43
Item
3. Default Upon Senior Securities
None.
Item
4. Mine Safety Disclosures
Not
applicable.
Item
5. Other Information
None.
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
3.1
Certificate of Incorporation of Vivos Therapeutics, Inc. filed with Delaware Secretary of State on August 12, 2020. (1)
3.2
Amended and Restated Bylaws of Vivos Therapeutics, Inc. (1)
3.3
Certificate of Conversion filed with Delaware Secretary of State on August 12, 2020. (1)
3.4
Certificate of Amendment to the Certificate of Incorporation of Vivos Therapeutics, Inc., dated October 25, 2023. (2)
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.
**
Furnished herewith.
(1)
Incorporated by reference to the Company’s Registration Statement on Form S-1, filed with the SEC on October 9, 2020.
(2)
Incorporated by refence to the Company’s Current Report on Form 8-K, filed with the SEC on October 27, 2023.
44
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 14, 2024
By:
/s/
R. Kirk Huntsman
R.
Kirk Huntsman
Chairman
of the Board and Chief Executive Officer
(principal
executive officer)
Date:
May 14, 2024
By:
/s/
Bradford Amman
Bradford
Amman
Chief
Financial Officer and Secretary
(principal
accounting officer)
45
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.