Item 8. Financial Statements and Supplementary Data
Item
8. Financial Statements and Supplementary Data.
TABLE
OF CONTENTS
Page
Reports of Independent Registered Public Accounting Firm (PCAOBID No. 659 )
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Financial
Statements:
Consolidated balance sheets as of December 31, 2024 and 2023
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Consolidated statements of operations for the years ended December 31, 2024 and 2023
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Consolidated statements of stockholders’ equity for the years ended December 31, 2024 and 2023
-75-
Consolidated statements of cash flows for the years ended December 31, 2024 and 2023
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Notes to consolidated financial statements
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- 71 -
Report
of Independent Registered Public Accounting Firm
To the Shareholders and the Board of Directors of
Vivos Therapeutics, Inc.
and subsidiaries
Opinion on the Financial Statements
We have audited the accompanying consolidated
balance sheets of Vivos Therapeutics, Inc. and subsidiaries (the Company) as of December 31, 2024 and 2023, the related consolidated statements
of operations, stockholders’ equity and cash flows for the years then ended, and the related notes (collectively referred to as
the consolidated financial statements). In our opinion, the consolidated financial statements present fairly, in all material respects,
the consolidated financial position of the Company as of December 31, 2024 and 2023, and the consolidated results of its operations and
its cash flows for the years then ended, in conformity with accounting principles generally accepted in the United States of America.
Going Concern Uncertainty
The accompanying consolidated financial
statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note 2 to the consolidated financial
statements, the Company has suffered recurring losses from operations that raise substantial doubt about its ability to continue as a
going concern. Management’s plans in regard to these matters are also described in Note 2. The consolidated financial statements
do not include any adjustments that might result from the outcome of this uncertainty.
Basis for Opinion
These consolidated financial statements are the responsibility
of the Company’s management. Our responsibility is to express an opinion on the Company’s consolidated financial statements
based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (“PCAOB”)
and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable
rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with
the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the
consolidated financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have,
nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audit, we are required to obtain
an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of
the Company’s internal control over financial reporting. Accordingly, we express no such opinion.
/s/
Moss Adams, LLP
Denver,
Colorado
March
31 st , 2025
We
have served as the Company’s auditor since 2023.
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VIVOS
THERAPEUTICS, INC.
Consolidated
Balance Sheets
December
31, 2024 and 2023
(In
Thousands, Except Per Share Amounts)
2024
2023
Current assets
Cash and cash equivalents
$ 6,260
$ 1,643
Accounts receivable, net of allowance of $ 390 and $ 268 , respectively
430
202
Prepaid expenses and other current assets
783
616
Total current assets
7,473
2,461
Long-term assets
Goodwill
2,843
2,843
Property and equipment, net
3,350
3,314
Operating lease right-of-use asset
1,032
1,385
Intangible assets, net
370
420
Deposits and other
216
307
Total assets
$ 15,284
$ 10,730
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities
Accounts payable
$ 1,098
$ 2,145
Accrued expenses
2,234
2,334
Current portion of contract liabilities
896
2,138
Current portion of operating lease liability
477
474
Other current liabilities
273
198
Total current liabilities
4,978
7,289
Long-term liabilities
Contract liabilities, net of current portion
97
289
Employee retention credit liability
1,220
1,220
Operating lease liability, net of current portion
1,035
1,521
Total liabilities
7,330
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 5,889,520 shares as of December 31, 2024 and 1,833,877 shares as December 31, 2023
-
-
Additional paid-in capital
112,141
93,462
Accumulated deficit
( 104,187 )
( 93,051 )
Total stockholders’ equity
7,954
411
Total liabilities and stockholders’ equity
$ 15,284
$ 10,730
The
accompanying notes are an integral part of these consolidated financial statements.
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VIVOS
THERAPEUTICS, INC.
Consolidated
Statements of Operations
Years
Ended December 31, 2024 and 2023
(In
Thousands, Except Per Share Amounts)
2024
2023
Revenue
Product revenue
$ 7,874
$ 6,270
Service revenue
7,157
7,531
Total revenue
15,031
13,801
Cost of sales (exclusive of depreciation and amortization shown separately below)
6,012
5,530
Gross profit
9,019
8,271
Operating expenses
General and administrative
17,878
22,479
Sales and marketing
1,731
2,467
Depreciation and amortization
581
621
Total operating expenses
20,190
25,567
Operating loss
( 11,171 )
( 17,296 )
Non-operating income (expense)
Other expense
( 110 )
( 212 )
Excess warrant fair value
-
( 6,453 )
Change in fair value of warrant liability, net of issuance costs of $ 645
-
10,231
Other income
145
147
Loss before income taxes
( 11,136 )
( 13,583 )
Net loss
$ ( 11,136 )
$ ( 13,583 )
Net loss per share (basic and diluted)
$ ( 2.22 )
$ ( 11.14 )
Weighted average number of shares of Common Stock outstanding (basic and diluted)
5,019,886
1,219,381
The
accompanying notes are an integral part of these consolidated financial statements.
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VIVOS
THERAPEUTICS, INC.
Consolidated
Statements of Stockholders’ Equity
Years
Ended December 31, 2024 and 2023
(In
Thousands)
Shares
Amount
Capital
Deficit
Total
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 and warrants in private placement, net of issuance costs
210,000
-
2,764
-
2,764
Issuance of common stock and warrants to consultants for services
30,000
-
824
-
824
Issuance of common stock for purchase of assets
10,000
116
-
116
Issuance of commons stock upon exercise of warrants,
net of issuance costs
624,059
-
3,652
-
3,652
Shares added for fractional shares pursuant to reverse stock split
39,226
-
-
-
-
Reclassification of liabilities-classified warrants to equity
-
-
731
-
731
Stock-based compensation expense
-
-
1,106
-
1,106
Net loss
-
-
-
( 13,583 )
( 13,583 )
Balances, December 31, 2023
1,833,877
$ -
$ 93,462
$ ( 93,051 )
$ 411
Balances
1,833,877
$ -
$ 93,462
$ ( 93,051 )
$ 411
Issuance of common stock and warrants in private placement, net of issuance costs
2,312,530
-
14,240
-
14,240
Issuance of commons stock upon exercise of warrants,
net of issuance costs
1,738,393
-
3,635
-
3,635
Issuance of common stock to consultants for services
4,720
-
11
11
Issuance of warrants to consultants for services
-
-
31
-
31
Stock-based compensation expense
-
-
762
-
762
Net loss
-
-
-
( 11,136 )
( 11,136 )
Balances, December 31, 2024
5,889,520
$ -
$ 112,141
$ ( 104,187 )
$ 7,954
Balances
5,889,520
$ -
$ 112,141
$ ( 104,187 )
$ 7,954
The
accompanying notes are an integral part of these consolidated financial statements.
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VIVOS
THERAPEUTICS, INC.
Consolidated
Statements of Cash Flows
Years
Ended December 31, 2024 and 2023
(In
Thousands)
2024
2023
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss
$ ( 11,136 )
$ ( 13,583 )
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation expense
762
1,106
Depreciation and amortization
581
621
Fair value of common stock issued for services
11
87
Fair value of warrants issued for services
31
737
Change in fair value of warrant liability, net of issuance costs of $ 645
-
( 10,231 )
Excess warrant fair value
-
6,453
Changes in operating assets and liabilities:
Accounts receivable
( 228 )
255
Operating lease liabilities, net
( 129 )
( 109 )
Prepaid expenses and other current assets
( 167 )
832
Deposits
105
80
Accounts payable
( 1,048 )
734
Accrued expenses
( 39 )
422
Employee retention credit liability
-
1,220
Other liabilities
-
41
Contract liability
( 1,434 )
( 611 )
Net cash used in operating activities
( 12,691 )
( 11,946 )
CASH FLOWS FROM INVESTING ACTIVITIES:
Acquisitions of property and equipment
( 568 )
( 803 )
Payment for asset purchase
-
( 50 )
Net cash used in investing activities
( 568 )
( 853 )
CASH FLOWS FROM FINANCING ACTIVITIES:
Proceeds from issuance of common stock
7,796
4,000
Proceeds from exercise of warrants
7,500
-
Proceeds from exercise of pre-funded warrants
3,941
8,000
Payments for issuance costs
( 1,361 )
( 1,077 )
Net cash provided by financing activities
17,876
10,923
Net increase (decrease) in cash and cash equivalents
4,617
( 1,876 )
Cash and cash equivalents at beginning of year
1,643
3,519
Cash and cash equivalents at end of year
$ 6,260
$ 1,643
2024
2023
SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION:
Cash paid for interest
$ 9
$ -
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 consolidated financial statements.
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VIVOS
THERAPEUTICS, INC.
Notes to the Consolidated Financial Statements
NOTE
1 - ORGANIZATION, DESCRIPTION AND SIGNIFICANT ACCOUNTING POLICIES
Organization
BioModeling
Solutions, Inc. (“BioModeling”) was organized on March 20, 2007 as an Oregon limited liability company, and subsequently
incorporated in 2013. On August 16, 2016, BioModeling entered into a share exchange agreement (the “SEA”) with First Vivos,
Inc. (“First Vivos”), and Vivos Therapeutics, Inc. (“Vivos”), a Wyoming corporation established on July 7, 2016
to facilitate this share exchange combination transaction. Vivos was formerly named Corrective BioTechnologies, Inc. until its name changed
on September 6, 2016 to Vivos Biotechnologies and on March 2, 2018 to Vivos Therapeutics, Inc. and had no substantial pre-combination
business activities. First Vivos was incorporated in Texas on November 10, 2015. Pursuant to the SEA, all of the outstanding shares of
common stock and warrants of BioModeling and all of the shares of 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, we 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 our Board of Directors under authority granted by the our stockholders
at our 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. We offer
three separate clinical pathways or programs to providers—Guided Growth and Development, Lifeline, and Complete Airway Repositioning
and Expansion (“C.A.R.E.”). 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 journeys. For
example, the Guided Growth and Development program features the Vivos Guide and PE x appliances along with CO 2 laser
treatments and other adjunctive therapies designed for treating palatal growth 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.
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Our
flagship C.A.R.E. program, which is part of The Vivos Method, features our 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 C.A.R.E. 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 approximately 58,000 patients treated to date
worldwide with our entire current suite of products, there have been very few instances of relapse.
We
offer a suite of diagnostic and support products and services to dental and medical providers and distributors who service 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
(which optimizes medical and dental reimbursement), (v) advanced training and continuing education courses at our 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) our Medical Integration Division (“MID”), which
historically has managed independent medical practices under management and development agreements which paid us from six ( 6 %)
to eight ( 8 %)
percent of all net revenue from sleep-related services as well as development fees. With the shift in focus to the alliance-based
marketing and distribution model described below, the MID will be pursuing strategic alliances with sleep centers to provide better options using
Vivos products for patients who have been diagnosed with OSA.
Our
business model has historically been to teach, train, and support dentists, medical doctors, and distributors in the use of our products
and services. Dentists who use our products and services typically enroll in a variety of live or online training and educational programs
offered through our Vivos Institute; a 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. They
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.” We charge up front enrollment fees to educate and
train new providers. We also charge for the ancillary support services listed above and view each product and service as a revenue/profit
center.
Over the course of 2024, we worked to pivot our business strategy and began
to steadily decrease our prior dependence on dentists to sell our products and our dependence on VIP enrollment revenue. This new business
strategy is focused on contractual alliances with (and, in the future, potential outright acquisitions by us of) OSA healthcare providers,
including dentists, sleep centers and others and is based on a profit-sharing model between us and the provider which aligns our revenue
generation more directly to sales of our novel appliances.
Basis
of Presentation and Consolidation
The
accompanying consolidated financial statements, which include the accounts of the Company and its wholly owned subsidiaries (BioModeling,
First Vivos, Vivos Therapeutics (Canada) Inc., Vivos Management and Development, LLC, Vivos Del Mar Management, LLC, Vivos Modesto Management,
LLC, Vivos Therapeutics DSO LLC, a Colorado limited liability company, and Vivos Airway Alliances, LLC, a Colorado limited liability
company), are prepared in conformity with generally accepted accounting principles in the United States of America (“U.S. GAAP”).
All significant intercompany balances and transactions have been eliminated in consolidation.
Emerging
Growth Company 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, we 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.
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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. We currently expect to
retain our status as an EGC until the year ending December 31, 2025, but this status could end sooner under certain circumstances.
Revenue
Recognition
We
generate revenue from the sale of products and services. A significant majority of the our 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 fiscal quarters prior to second quarter of 2023, and 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 we expect 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”), we determine 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
We
review our 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 $ 23,200 , 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. We
recognize this revenue as performance obligations are met. Accordingly, the contract liability for unearned revenue is a significant
liability for us. Provisions for discounts are provided in the same period that the related revenue from the products and/or services
is recorded.
We
enter into programs that may provide for multiple performance obligations. Commencing in 2018, we 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. We allocate 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.
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The
right to sell is similar to a license of intellectual property because without it the VIP cannot purchase appliances from us. 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, we believe 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.
We
use significant judgements in revenue recognition including an estimation of customer life over which it recognizes the right to sell.
We have 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, we have estimated
customer life for each year a contract is initiated. Estimated customer lives have been calculated separately for each year and were
estimated between 14 months and 27 months for the years 2020 through 2024, depending upon the length of time customers stayed active
each year. 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.
Given that our alliance-based marketing and distribution model is very new and has yet to generate significant revenues,
we are in the process of developing and implementing our revenue recognition plan for revenues derived from this model.
Other
Service Revenue
In
addition to VIP enrollment service revenue, in 2020 we launched BIS, an additional service on a monthly subscription basis, which includes
our AireO2 medical billing and practice management software. Revenue for these services is recognized monthly during the month the services
are rendered.
We
also offer our 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.
Allocation
of Revenue to Performance Obligations
We
identify all goods and services that are delivered separately under a sales arrangement and allocate 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, we offer 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
- 80 -
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 us 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 us agree upon the amount of consideration that the customer will pay in exchange for the we provide. 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, we update 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, we also generate revenue from the sale of our line of oral devices and preformed guides (known as
appliances or systems) to our customers, the VIP dentists or OSA patients directly in the case of our strategic alliance model. These include the DNA appliance ® , mRNA
appliance ® , the mmRNA appliance, the Versa, the Vida, the Vida Sleep and others. We expanded our 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. We contract with VIPs for the sale of the appliance, and we are not involved in the sale of the
products and services from the VIP to the VIP’s patient.
Our
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. We utilize our 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 we operate. We utilize third party contract
manufacturers or labs to produce our patient-customized, patented appliances and our preformed guides. The manufacturer designated by
us produces the appliance in strict adherence to our patents, design files, treatments, processes and procedures and under the direction
and specific instructions from us, ships the appliance to the VIP who ordered the appliance from us. All of our contract manufacturers
are required to follow our master design files in the production of appliances, or the lab will be in violation of the FDA’s rules
and regulations. We have performed an analysis and concluded we are the principal in the transaction since we have control of the product
and we reporting revenue gross. We bill 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 our direction.
In
support of the VIPs using our appliances for their patients, we utilize a team of trained technicians to measure, order and fit each
appliance. Revenue is recognized differently for Company owned centers and distribution alliances with third party sleep centers than
it does for revenue from VIPs. Upon scheduling the patient (which is our customer in this case), the center takes a deposit and reviews
the patient’s insurance coverage. We recognize revenue in the centers after the appliance is received from the manufacturer and
once the appliance is fitted and provided to the patient.
We
offer 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 our products, to purchase our products for their own practices. In addition, from time to
time, we offer credits to incentivize VIPs to adopt the our 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.
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Use
of Estimates
The
preparation of financial statements and related disclosures in conformity with U.S. GAAP requires us to make judgments, assumptions,
and estimates that affect the amounts reported in its consolidated financial statements and accompanying notes. We base our estimates
and assumptions on existing facts, historical experience, and various other factors that we believe are reasonable under the circumstances,
to determine the carrying values of assets and liabilities that are not readily apparent from other sources. Our significant accounting
estimates include, but are not necessarily limited to, assessing collectability on accounts receivable, determining 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.
We believe we have made appropriate accounting estimates based on the facts and circumstances available as of the reporting date. To
the extent there are material differences between our estimates and the actual results, our 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 our 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. We evaluate the collectability of its accounts receivable and determine 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 we are aware of a customer’s inability to meet its financial obligation, we may individually evaluate
the related receivable to determine the allowance for expected credit losses. We use 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. We do not begin depreciating assets until assets are placed in service.
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, 2024. Accordingly no impairment was required.
Intangible
assets consist of assets acquired from First Vivos and costs paid to (i) MyoCorrect, from whom we acquired certain assets related to
its OMT service in March 2021, (ii) Lyon Management and Consulting, LLC and its affiliates (“Lyon Dental”), from whom we
acquired certain medical billing and practice management software, licenses and contracts in April 2021 (including the software underlying
AireO2) for work related to our acquired patents, intellectual property and customer contracts and (iii) AFD, from whom we 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.
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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, 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.
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 were 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.
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, we 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 we are entitled to such funds). In our case, we 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 us. However, the IRS issued a renewed warning regarding the ERTC
on March 7, 2023 urging taxpayers to carefully review the ERTC guidelines. We continue 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 the years ended December 31, 2024 and 2023, approximately $ 1.2 million is reflected
under long-term liabilities.
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Loss
and Gain Contingencies
We
are 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, we accrue that
amount. Alternatively, when no amount within a range of loss appears to be a better estimate than any other amount, we accrue the lowest
amount in the range. If we determine that a loss is reasonably possible and the range of the loss is estimable, then we disclose the
range of the possible loss. If we cannot estimate the range of loss, we will disclose the reason why it cannot estimate the range of
loss. We regularly evaluate current information available to us to determine whether an accrual is required, an accrual should be adjusted
and if a range of possible loss should be disclosed. Legal fees related to contingencies are charged to general and administrative expense
as incurred. Contingencies that may result in gains are not recognized until realization is assured, which typically requires collection
in cash.
Share-Based
Compensation
We
measure 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. We compute the fair value of stock options using the Black-Scholes-Merton
(“BSM”) option pricing model. We estimate the expected term using the simplified method which is the average of the vesting
term and the contractual term of the respective options. We determine the expected price volatility based on the historical volatilities
of shares of our peer group as we do not have sufficient trading history for our Common Stock. Industry peers consist of several public
companies in the bio-tech industry similar to us in size, stage of life cycle and financial leverage. We 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 our own stock price becomes available, or unless circumstances change such that the identified companies are no longer similar to
us, in which case, more suitable companies whose share prices are publicly available would be utilized in the calculation. We recognize
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. We recognize
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 research and development of new products
and enhancements to existing products. Research and development costs incurred were approximately $ 0.1 million during each of the years
ended December 31, 2024 and 2023. These are recorded on the statement of operations under sales and marketing expense.
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.
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Income
Taxes
We
account 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, we consider tax regulations of the jurisdictions in which
we operate, 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, we recognize 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. We recognize 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
We
account for our 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 and ASC 480, Distinguishing Liabilities from Equity . Warrants
classified as equity are recorded at fair value as of the date of issuance on our 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 our 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, expected volatility,
expected life, yield, and risk-free interest rate.
Segment
Information
Operating
segments are defined as components of an enterprise about which separate financial information is available that is evaluated regularly
by a company’s chief operating decision maker (“CODM”), or a decision-making group, in deciding how to allocate resources
and in assessing financial performance. As of December 31, 2024, the Company’s CODM was the Company’s Chief Executive Officer,
and we concluded that we have one reportable segment. Refer to Note 15, “Segment Information”, for additional disclosures
regarding segment information.
Accounting
Pronouncements
Presented
below is a discussion of new accounting standards including deadlines for adoption assuming that we retain our designation as an EGC.
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Recently
Adopted Accounting Pronouncements
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. Effective December 31, 2024, we adopted
the provisions of this ASU which resulted in the inclusion of additional disclosures within Note 15, “Segment Information”.
Recent
Accounting Pronouncements Yet to be Adopted
In
November 2024, the FASB issued ASU No. 2024-03, Disaggregation of Income Statement Expenses (“ASU 2024-03”). The standard’s
purpose is “to improve the disclosures about a public business entity’s expenses and address requests from investors for
more detailed information about the types of expenses (including purchases of inventory, employee compensation, depreciation, amortization,
and depletion) in commonly presented expense captions (such as cost of sales, SG&A, and research and development).” Public
companies will be required to disclose in the notes to financial statements specified information about certain costs and expenses at
each interim and annual reporting period. Specifically, they will be required to:
1.
Disclose
the amounts of (a) purchases of inventory; (b) employee compensation; (c) depreciation; (d) intangible asset amortization; and (e)
depreciation, depletion, and amortization recognized as part of oil- and gas-producing activities (or other amounts of depletion
expense) included in each relevant expense caption.
2.
Include
certain amounts that are already required to be disclosed under current generally accepted accounting principles (GAAP) in the same
disclosure as the other disaggregation requirements.
3.
Disclose
a qualitative description of the amounts remaining in relevant expense captions that are not separately disaggregated quantitatively.
4.
Disclose
the total amount of selling expenses and, in annual reporting periods, an entity’s definition of selling expenses.
The
amendments in the ASU are effective for annual reporting periods beginning after December 15, 2026, and interim reporting periods beginning
after December 15, 2027. Early adoption is 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. We have incurred losses since inception, including $ 11.1 and $ 13.6 million for the years ended December
31, 2024 and 2023, respectively, resulting in an accumulated deficit of approximately $ 104.2 million as of December 31, 2024.
Net
cash used in operating activities amounted to approximately $ 12.7 and $ 11.9 million for years ended December 31, 2024 and 2023, respectively.
As of December 31, 2024, we had total liabilities of approximately $ 7.3 million.
As
of December 31, 2024, we had approximately $ 6.3 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.
We
have implemented cost savings measures that lead to reduced impact to cash used in operations. However, sales did not grow in 2023 or
2024 as anticipated, as our product offerings and strategies continue to be refined. As such, we have raised equity capital in late 2023
and throughout 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.
- 86 -
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. We expect the Strategic Alliance Agreement (“SAA”) with Rebis to increase patient volume,
drive top line revenue and lower customer acquisition costs and overhead. However, there can be no assurances that adequate additional
funding will be available on favorable terms, or at all. If such funds are not available in the future, or that the SAA agreement will
result in the patient volume and financial results within the expected timeline and 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.
NOTE
3 - REVENUE, CONTRACT ASSETS AND CONTRACT LIABILITIES
Net
Revenue
For
the years ended December 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
2024
2023
Product revenue
Appliances
$ 5,601
$ 6,081
Guides
2,273
189
Total product revenue
7,874 (1)
6,270
Service revenue
VIP
$ 2,485 (2)
$ 3,922
Billing intelligence services
840
887
Sleep testing services
1,282
1,185
Myofunctional therapy services
609
861
Sponsorship/seminar/other
1,941
676
Total service revenue
7,157
7,531
Total revenue
$ 15,031
$ 13,801
(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)
Service
revenue from the sale of VIP enrollments, billing services and therapy 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.
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Changes
in Contract Liabilities
The
key components of changes in contract liabilities for years ended December 31, 2024 and 2023 are as follows (in thousands):
SCHEDULE OF CONTRACT LIABILITY
2024
2023
Beginning balance, January 1
$ 2,427
$ 3,038
New contracts, net of cancellations
2,117
3,730
Revenue recognized
( 3,551 )
( 4,341 )
Ending balance, December 31
$ 993
$ 2,427
The
current portion of deferred revenue is approximately $ 0.9 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 $ 1.7 and $ 0.7 million for
the years ended December 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 $ 0.4 million at December 31,
2024, $ 0.2 million at December 31, 2023 and $ 0.5 million at January 1, 2023. Adjustment to the allowance are recorded in bad debt expense
under general and administrative expenses in the consolidated statement of operations. An allowance of $ 0.4 and $ 0.3 million existed
as of December 31, 2024 and 2023.
NOTE
4 - PROPERTY AND EQUIPMENT, NET
As
of December 31, 2024 and 2023, property and equipment consist of the following (in thousands):
SCHEDULE OF PROPERTY AND EQUIPMENT
2024
2023
Furniture and equipment
$ 1,349
$ 1,321
Leasehold improvements
2,479
2,479
Construction in progress
1,857
1,435
Molds and other
523
405
Gross property and equipment
6,208
5,640
Less accumulated depreciation
( 2,858 )
( 2,326 )
Net Property and equipment
$ 3,350
$ 3,314
Leasehold
improvements relate to the Vivos Institute (a 15,000 square foot facility where we provide advanced post-graduate education and certification
to dentists, dental teams, and other healthcare professionals in a live and hands-on setting) and the two Company-owned dental centers
in Colorado. Total depreciation and amortization expense was $ 0.6 million for the years ended December 31, 2024 and 2023.
NOTE
5 - GOODWILL AND INTANGIBLE ASSETS
Goodwill
Goodwill
of $ 2.8 million as of December 31, 2024 and 2023, consist of the following acquisitions (in thousands):
SCHEDULE OF GOODWILL
Acquisitions
2024
2023
BioModeling
$ 2,619
$ 2,619
Empowered Dental
52
52
Lyon Dental
172
172
Total goodwill
$ 2,843
$ 2,843
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Intangible
Assets
As
of December 31, 2024 and 2023, identifiable intangible assets were as follows (in thousands):
SCHEDULE OF IDENTIFIABLE INTANGIBLES
2024
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
( 2,289 )
( 2,239 )
Net intangible assets
$ 370
$ 420
Amortization
expense of identifiable intangible assets was less than $ 0.1 million for the years ended December 31, 2024 and 2023. The estimated future
amortization of identifiable intangible assets is as follows (in thousands):
SCHEDULE OF ESTIMATED FUTURE AMORTIZATION OF IDENTIFIABLE ASSETS
As of December 31,
2025
50
2026
35
2027
29
2028
29
2029
29
Thereafter
198
Total
$ 370
NOTE
6 - OTHER FINANCIAL INFORMATION
Accrued
Expenses
As
of December 31, 2024 and 2023, accrued expenses consist of the following (in thousands):
SCHEDULE OF ACCRUED EXPENSES
2024
2023
Accrued payroll
$ 1,001
$ 1,498
Accrued legal and other
752
509
Accrued sales tax
481
327
Total accrued liabilities
$ 2,234
$ 2,334
NOTE
7 – PREFERRED STOCK
As
of December 31, 2024, our 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.
- 89 -
NOTE
8 – COMMON STOCK
We
are authorized to issue 200,000,000 shares of Common Stock. Holders of Common Stock are entitled to one vote for each share held. Our
Board of Directors may declare dividends payable to the holders of Common Stock.
Common
Stock Transactions During the Periods Presented
On
January 9, 2023, we closed a private placement (the “January 2023 Private Placement”) pursuant to which we 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, we acquired certain U.S. and international patents, patent applications, trademarks, product rights, and other miscellaneous
intellectual property from AFD. Pursuant to the asset acquisition, we agreed to issue 10,000 shares of Common Stock in addition to cash
consideration of $ 50,000 . As a result of this transaction, we recorded intangible assets of approximately $ 0.2 million. As part of the
associated Asset Purchase Agreement, we 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 our accounting policy, the
contingent consideration obligation will be recorded as the contingency is resolved and the consideration is paid or becomes payable.
In
addition, we 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”), we 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 our issued and outstanding Common Stock
was combined into one share of Common Stock. As a result, our 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 our 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 our 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, we closed a private placement (the “November 2023 Private Placement”) with an institutional investor pursuant
to which we 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, 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 us 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 our 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.
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On
June 10, 2024 we, entered into a securities purchase agreement (the “SPA”) with V-CO Investors LLC, a Wyoming limited liability
company (“V-CO”). V-CO is an affiliate of New Seneca Partners Inc., a Michigan corporation (“Seneca”), an independent
private equity firm. Pursuant to the SPA, we sold to V-CO in a private placement offering (the “Private Placement”): (i)
169,498 shares (the “Shares”) of our Common Stock, (ii) a pre-funded warrant to purchase 3,050,768 shares of Common Stock
(the “Pre-Funded Warrant”, with the shares of Common Stock underlying the Pre-Funded Warrant being referred to as the “PFW
Shares”), and (iii) a Common Stock Purchase Warrant to purchase up to 3,220,266 shares of Common Stock (the “Common Stock
Purchase Warrant, and together with the Pre-Funded Warrant, the “Warrants”, and with the shares of Common Stock underlying
the Common Stock Purchase Warrant being referred to as the “Warrant Shares”).
V-CO
paid a purchase price of $ 2.329 for each Share and Pre-Funded Warrant Share and associated Common Stock Purchase Warrant, with such price
being established for purposes of compliance with the listing rules of the Nasdaq Stock Market LLC. The Private Placement closed on September
10, 2024. We received gross proceeds of $ 7,500,000 from the Private Placement. We intend to use the net proceeds from the Private Placement
for general working capital and general corporate purposes. No placement agent was used in connection with the Private Placement. The
Common Stock Purchase Warrant has a five year term, an exercise price of $ 2.204 per share and became exercisable immediately as of the
date of issuance. The Pre-Funded Warrant has a term ending on the complete exercise of the Pre-Funded Warrant, an exercise price of $ 0.0001
per share and became exercisable immediately as of the date of issuance. The Warrants also contain customary stock-based (but not price-based)
anti-dilution protection as well as beneficial ownership limitations that may be waived at the option of each holder upon 61 days’
notice to the Company.
The
SPA provides that for a period of three (3) years from the closing of the offering, Seneca shall be entitled to (i) receive notice of
any regular or special meeting of our board of directors (the “Board”) at the time such notice is provided to the members
of the Board, (ii) receive copies of any materials delivered to our directors in connection with such meetings and (iii) allow one Seneca
representative (who shall be an officer or employee of Seneca) to attend and participate (but not vote) in all such meetings of the Board.
The SPA also includes standard representations, warranties, indemnifications, and covenants of the Company and V-CO.
The
terms of the SPA require us to file a registration statement on Form S-3 or other appropriate form (the “Resale Registration Statement”)
registering the Shares, the PFW Shares and the Warrant Shares (collectively, the “Registerable Securities”) for resale. Such
Resale Registration Statement was filed with the SEC on July 30, 2024, and was declared effective by the SEC on August 7, 2024. Pursuant
to the SPA, we must also use its commercially reasonable efforts to keep the Resale Registration Statement continuously effective (including
by filing a post-effective amendment to the Resale Registration Statement or a new registration statement if the Resale Registration
Statement expires) for a period of three (3) years after the date of effectiveness of the Resale Registration Statement or for such shorter
period as such securities no longer constitute Registrable Securities, subject to certain limitations specified in the SPA.
On
September 18, 2024, we entered into a securities purchase agreement (the “Purchase Agreement”) with certain institutional
investors in connection with a registered direct offering (the “Offering”), priced at-the-market under Nasdaq Stock Market
rules, to purchase 1,363,812 shares (the “Shares”) of our common stock, par value $ 0.0001 per share (“Common Stock”)
at a purchase price of $ 3.15 per Share. No common stock purchase warrants were offered or issued to investors in the Offering. Offering
closed on September 20, 2024.
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H.C.
Wainwright & Co., LLC, pursuant to an engagement agreement with us, dated May 2, 2024 and amended on August 2, 2024 (as amended,
the “Engagement Agreement”), acted as the exclusive placement agent (the “Placement Agent”) for the Offering.
Pursuant to the Engagement Agreement, we have paid the Placement Agent (i) a cash fee equal to 7.0% of the aggregate gross proceeds of
the Offering, and (ii) a management fee of 1.0% of the aggregate gross proceeds of the Offering. We have also agreed to reimburse the
Placement Agent for certain expenses and legal fees. In addition, we issued to the Placement Agent, or its designees warrants (the “Placement
Agent Warrants”) to purchase up to 95,467 shares of Common Stock (or 7% of the number of Shares sold in the Offering) at an exercise
price of $ 3.9375 per share of Common Stock, exercisable beginning upon issuance until five years from the commencement of sales in the
Offering.
The
gross proceeds to us from the Offering were approximately $ 4.3 million, before deducting the Placement Agent’s fees and other offering
expenses payable by us. We intend to use the net proceeds from the offering for working capital and general corporate purposes.
The
Shares were issued pursuant to an effective shelf registration statement on Form S-3 that was filed with the SEC (File No. 333-262554)
on February 7, 2022 and declared effective on February 14, 2022. A prospectus supplement relating to the Offering has been filed with
the SEC.
The
Purchase Agreement contains customary representations, warranties and agreements of the Company and the investors and customary indemnification
rights and obligations of the parties. Pursuant to the terms of the Purchase Agreement, we agreed to certain restrictions on the issuance
and sale of our shares of Common Stock and securities convertible into shares of Common Stock for a period of 30 days following the closing
of the Offering. We also agreed not to effect or agree to effect any Variable Rate Transaction (as defined in the Purchase Agreement)
until one year following the closing of the Offering, subject to certain exceptions.
On
December 22, 2024, we entered into a securities purchase agreement (the “December 2024 SPA”) with certain institutional investors
(who are the selling stockholders named herein) in connection with a registered direct offering, priced at-the-market under Nasdaq Stock
Market rules, to purchase 709,220 shares of Common Stock and, in a concurrent private placement (collectively, with the registered direct
offering, the “December 2024 Offering”), warrants (the “December 2024 Warrants”) to purchase up to 709,220 shares
of Common Stock (the shares of Common Stock issuable upon exercise of the December 2024 Warrants, the “December 2024 Warrant Shares”).
The combined purchase price per share for the December 2024 Warrants is $ 4.935 . The December 2024 Warrants are immediately exercisable
upon issuance, will expire two years following the issuance date and have an exercise price of $ 4.81 per share.
We
agreed to file a registration statement under the Securities Act of 1933, as amended (the “Securities Act”), with the SEC,
covering the resale of the December 2024 Warrants Shares within 30 calendar days following the date of the December 2024 SPA and to use
commercially reasonable efforts to cause the registration statement to be declared effective by the SEC within 90 days following the
closing of the December 2024 Offering.
Pursuant
to the HCW Engagement Agreement dated May 2, 2024, as amended on August 2, 2024 and December 22, 2024 with us, HCW acted as the Placement
Agent for the December 2024 Offering. Pursuant to the HCW Engagement Agreement, we have (i) paid the Placement Agent a cash fee equal
to 7.0% of the aggregate gross proceeds of the December 2024 Offering, (ii) paid the Placement Agent a management fee of 1.0% of the
aggregate gross proceeds of the December 2024 Offering, and (iii) reimbursed the Placement Agent for certain expenses and legal fees.
In addition, upon the exercise of any December 2024 Warrants for cash, we have agreed to (i) pay the Placement Agent a cash fee equal
to 7.0% of the aggregate exercise price paid in cash, (ii) pay the Placement Agent a management fee of 1.0% of the aggregate exercise
price paid in cash and (iii) issue to the Placement Agent or its designees warrants to purchase shares of Common Stock representing 7%
of the shares of Common Stock underlying the December 2024 Purchase Warrants that have been exercised.
We
have also issued to the Placement Agent or its designees (who are among the selling stockholders named herein) warrants (the “December
2024 PA Warrants”) to purchase up to 95,467 shares of Common Stock (or 7% of the number of shares sold in the December 2024 Offering)
at an exercise price of $ 6.1688 per share of Common Stock, exercisable beginning upon issuance until two years following the issuance
date. We registered the Common Stock underlying the December 2024 PA Warrants for public resale pursuant to the registration statement
filed on January 31, 2025.
- 92 -
The
gross proceeds from the December 2024 Offering were approximately $ 3.5 million, before deducting the Placement Agent’s fees and
other offering expenses payable by us of approximately $ 0.5 million.
As of December 31, 2024 and 2023 all warrants outstanding have been classified as equity and recorded at fair values
of the date of issuance on the Company’s consolidated balance sheets and there have been no further adjustments to their issuance
date valuation, The guidance in this ASC 815, Derivatives and Hedging and ASC 480, Distinguishing Liabilities from Equity, has
been considered in making this assessment.
NOTE
9 – STOCK OPTIONS AND WARRANTS
Stock
Options
In
2017, our 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. Our shareholders have approved a total reserve
of 53,333 shares of Common Stock for issuance under the 2017 Plan.
On
September 22, 2023, our stockholders approved an amendment and restatement of the 2019 Plan to increase the number shares or our Common
Stock available for issuance thereunder by 80,000 shares of Common Stock such that, after amendment and restatement of the 2019 Plan,
126,667 shares of Common Stock are available for issuance under the 2019 Plan. As of December 31, 2024, awards (in the form of options)
for an aggregate of 174,380 shares of Common Stock have been issued under our 2019 Plan. A total of 287 shares remaining for issuance
were retired with the approval and adoption of the 2024 Omnibus Plan (as further described below).
On
November 26, 2024, our shareholders approved and adopted the Vivos Therapeutics, Inc. 2024 Omnibus Equity Incentive Plan (or the “2024
Omnibus Plan”). The 2024 Omnibus Plan automatically replaced and superseded the 2019 Plan. Under the 2024 Omnibus Plan, a total
of 1,600,000 shares are available for future use. No awards are to be granted under the 2019 Plan or any other prior plan on or after
the effective date of the 2024 Omnibus Plan and after the 2024 Omnibus Plan became effective any unused shares left in the 2019 Plan
are to be retired. We anticipate that the 1,600,000 shares will allow the 2024 Omnibus Plan to operate for several years, although this
could change based on other factors, including but not limited to merger and acquisition activity. The purpose of the 2024 Omnibus Plan
is to promote the success and enhance the value of the Company by linking the personal interest of the participants to those of our stockholders
by providing the participants with an incentive for outstanding performance. Any non-employee director, officer, employee or consultant
of the Company or its subsidiaries or affiliates will be eligible to participate in the 2024 Omnibus Plan. As of December 31, 2024, we
had five non-employee directors, two officers, 110 employees and three consultants, although we expect that, based on our current usage,
awards will be generally limited to approximately five non-employee directors, two officers ten employees, and three consultants. The
2024 Omnibus Plan provides for the grant of options to purchase shares of our Common Stock, including stock options intended to qualify
as incentive stock options (“ISOs”) under Section 422 of the Code and nonqualified stock options that are not intended to
so qualify (“NQSOs”), stock appreciation rights (“SARs”), restricted stock awards, and other equity-based or
equity-related awards including restricted stock units and performance units (each, an “Award”). As of December 31, 2024,
awards (in the form of options) for an aggregate of 1,020,487 shares of Common Stock have been issued under our 2024 Omnibus Plan.
- 93 -
The
following table summarizes all stock options as of December 31, 2024 and 2023 (shares in thousands):
SCHEDULE OF STOCK OPTIONS
2024
2023
Shares
Price
(1)
Term
(2)
Shares
Price
(1)
Term
(2)
Outstanding, at December 31,
127
$ 62.45
3.4
145
$ 72.25
3.3
Granted
1,125
2.62
16
9.89
Forfeited
( 14 )
-
( 34 )
-
Exercised
-
-
-
-
Outstanding, at December 31,
1,238 (3)
8.80
8.5
127 (4)
62.45
3.4
Exercisable, at December 31,
121 (4)
44.22
2.6
89 (5)
68.67
3.1
(1)
Represents
the weighted average exercise price.
(2)
Represents
the weighted average remaining contractual term until the stock options expire.
(3)
As
of December 31, 2024, and 2023 the aggregate intrinsic value of stock options outstanding was $ 0 .
(4)
As
of December 31, 2024, and 2023 the aggregate intrinsic value of exercisable stock options was $ 0 .
For
the year ended December 31, 2024 and 2023, the valuation assumptions for stock options granted under the 2017 Plan, the 2019 Plan and
2024 Omnibus Plan were estimated on the date of grant using the BSM option-pricing model with the following weighted-average inputs and
assumptions:
SCHEDULE OF WEIGHTED AVERAGE ASSUMPTIONS USED IN THE FAIR VALUE
2024
2023
Grant date closing price of Common Stock
$ 2.62
$ 9.89
Expected term (years)
5.8
3.5
Risk-free interest rate
3.8 %
3.9 %
Volatility
140 %
102 %
Dividend yield
0 %
0 %
Based
on the inputs and assumptions set forth above, the weighted-average grant date fair value per share for stock options granted for the
years ended December 31, 2024 and 2023 was $ 2.82 and $ 9.89 , respectively.
For
the years ended December 31, 2024 and 2023, we recognized approximately $ 0.8 and $ 1.1 million, respectively, of share-based compensation
expense reported under general and administrative expense in the income statement. Unrecognized expense relating to these awards as of
December 31, 2024 and 2023 was approximately $ 3.5 and $ 1.8 million, respectively, which will be recognized over the weighted average
remaining term of 8.5 and 3.7 years, respectively.
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Warrants
Following
is a summary of our warrants outstanding for the years ended December 31, 2024 and 2023 (shares in thousands):
SCHEDULE OF WARRANT OUTSTANDING
2024
2023
Shares
Price
(1)
Term
(2)
Shares
Price
(1)
Term
(2)
Outstanding, at December 31
2,821
$ 13.15
4.6
144
$ 137.50
2.6
Grants of warrants:
Private placement
7,125
3,265
Consultants for services
4
86
Warrant inducement
1,471
-
Exercised
( 1,739 )
( 624 )
Forfeited
( 24 )
( 50 )
Outstanding, at December 31
9,658 (3)
$ 3.22
3.9
2,821 (3)
$ 13.15
4.6
Exercisable, at December 31
9,605 (4)
$ 3.10
3.9
2,760 (4)
$ 9.30
3.5
(1)
Represents
the weighted average exercise price.
(2)
Represents
the weighted average remaining contractual term until the warrants expire.
(3)
As
of December 31, 2024, the aggregate intrinsic value of warrants outstanding was $ 0 million.
(4)
As
of December 31, 2024, the aggregate intrinsic value of warrants exercisable was $ 0 million.
For
the years ended December 31, 2024 and 2023, the valuation assumptions for warrants issued were estimated on the measurement date using
the BSM option-pricing model with the following weighted-average input and assumptions:
SCHEDULE OF WEIGHTED AVERAGE ASSUMPTIONS USED IN THE FAIR VALUE
2024
2023
Measurement date closing price of Common Stock (1)
$ 2.17
$ 3.83
Contractual term (years) (2)
3.7
3.4
Risk-free interest rate
4.4 %
4.7 %
Volatility
140 %
100 %
Dividend yield
0 %
0 %
(1)
Weighted
average grant price.
(2)
The
valuation of warrants is based on the expected term.
NOTE
10 - INCOME TAXES
For
the years ended December 31, 2024 and 2023, the domestic and foreign components of loss before income taxes consist of the following
(in thousands):
SCHEDULE OF LOSS BEFORE INCOME TAX
2024
2023
Domestic
$ ( 11,194 )
$ ( 13,626 )
International
58
43
Loss before income taxes
$ ( 11,136 )
$ ( 13,583 )
- 95 -
For
the years ended December 31, 2024 and 2023, we did not recognize any current or deferred income tax expense due to a valuation allowance
against all of its net deferred income tax assets.
A
reconciliation between the income tax benefit computed by applying the statutory U.S. federal income tax rate of 21% to the pre-tax loss,
and the income tax benefit recognized in the consolidated financial statements is as follows for the years ended December 31, 2024 and
2023 (in thousands):
SCHEDULE OF INCOME TAX EXPENSE (BENEFIT) DIFFERED FROM LOSS BEFORE INCOME TAXES
2024
2023
Income tax benefit computed at federal statutory rate
$ 2,351
$ 2,852
Apportioned state income tax benefit
253
365
Other permanent differences
( 121 )
( 174 )
Prior year adjustment to state net operating loss carryforwards
( 26 )
200
Non-qualified stock option cancellations
( 63 )
( 260 )
Other
( 201 )
( 86 )
Nontaxable gain on change in fair value of warrants, net of issuance costs
-
793
Change in valuation allowance
( 2,193 )
( 3,690 )
Total income tax benefit
$ -
$ -
As
of December 31, 2024 and 2023, the principal components of deferred tax assets and liabilities were as follows (in thousands):
SCHEDULE OF DEFERRED TAX ASSETS AND LIABILITIES
2024
2023
Deferred tax assets:
Net operating loss carryforwards
19,872
17,354
Stock based compensation
528
532
Lease liability
352
472
Property, equipment and intangibles
743
662
Other
282
649
Total deferred tax assets before valuation allowance
21,777
19,669
Valuation allowance
( 21,522 )
( 19,329 )
Total deferred income tax assets after valuation allowance
255
340
Deferred tax liabilities - ROU assets and other
( 255 )
( 340 )
Net deferred tax assets and liabilities
$ -
$ -
Management
assesses the available positive and negative evidence to estimate if it is more likely than not that sufficient future taxable income
will be generated to realize the existing deferred tax assets. A significant piece of objective negative evidence evaluated was the cumulative
net loss incurred since inception. Such objective evidence limits the ability to consider other subjective evidence such as our projections
for future growth. On the basis of this evaluation, a valuation allowance of $ 20.4 million was recognized as of December 31, 2024. For
the years ended December 31, 2024 and 2023, the valuation allowance increased by $ 1.1 million and $ 3.7 million, respectively.
As
of December 31, 2024, we have federal net operating loss (“NOL”) carryforwards of $ 83.8 million. We also have various state
NOL carry forwards. The determination of the state NOL carryforwards is dependent upon the apportionment percentages and state laws that
can change from year to year and impact the amount of such carryforwards. If federal NOL carryforwards are not utilized, approximately
$ 3.3 million will expire in 2036 and 2037. As of December 31, 2024, the remaining federal NOL carryforward of $ 80.5 million has no expiration
date.
Federal
and state laws impose substantial restrictions on the utilization of NOL carryforwards if we experience significant ownership changes
as defined in Section 382 of the Internal Revenue Code (“IRC”). Pursuant to IRC Section 382, annual use of our NOL carryforwards
may be limited in the event there is a cumulative change in ownership of more than 50% among 5% or greater shareholders (or shareholder
groups) over any three-year period. We are not currently utilizing its federal and state NOL carryforwards and have not completed a formal
study to determine if any past ownership changes may have triggered limitations under IRC Section 382. Our ability to use our remaining
NOL carryforwards may be further limited if we experience an IRC Section 382 ownership change in connection with future changes in our
stock ownership.
- 96 -
We
do not believe there are any significant uncertain tax positions as of and for the years ended December 31, 2024 and 2023. Accordingly,
no interest and penalties related to uncertain tax positions have been recognized for the years ended December 31, 2024 and 2023.
We
file income tax returns in the United States federal and various state jurisdictions. We are no longer subject to income tax examinations
for federal income taxes before 2021 or for states before 2020. Net operating loss carryforwards are subject to examination in the year
they are utilized regardless of whether the tax year in which they are generated has been closed by statute. The amount subject to disallowance
is limited to the NOL utilized. Accordingly, we may be subject to examination for prior NOL’s generated as such NOL’s are
utilized. As of December 31, 2024, we have filed all appropriate foreign operation tax returns.
NOTE
11 - LEASES
Operating
Leases
We
have entered into various operating lease agreements for certain offices, medical facilities and training facilities. These leases have
original lease periods expiring between 2022 and 2029 . Most leases include an option to renew and the exercise of a lease renewal option
typically occurs at the discretion of both parties . For purposes of calculating operating lease liabilities, lease terms are deemed not
to include options to extend the lease until it is reasonably certain that we will exercise that option. As of December 31, 2024, we
are party to three leases in Colorado and one in Utah, these leases have an expiration date between 2025 and 2029.
In
addition to base rent in these leases, we also pay our proportionate share of the operating expenses, as defined in the leases. These
payments are made monthly and adjusted annually to reflect actual charges incurred for operating expenses, such as common area maintenance,
taxes, and insurance.
As
of December 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
$ 483
$ 481
Total operating lease cost
$ 483
$ 481
Rent
expense is recognized on a straight-line basis over the lease term. Lease expense, including real estate taxes and related costs for
the years ended December 31, 2024 and 2023 aggregated approximately $ 0.5 million, respectively. This is included under general and administrative
expense.
As
of December 31, 2024 and 2023, the remaining lease terms and discount rate used are as follows (in thousands):
SCHEDULE OF REMAINING LEASE TERMS AND DISCOUNT RATE
2024
2023
Weighted-average remaining lease term (years)
2.8
3.7
Weighted-average discount rate
8.4 %
8.3 %
Supplemental
cash flow information related to leases as of December 31, 2024 and 2023 is as follows (in thousands):
SCHEDULE OF RELATED TO LEASES
2024
2023
Cash flow classification of lease payments:
Cash paid for operating lease liabilities
$ 613
$ 602
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As
of December 31, 2024 and 2023, the maturities of our future minimum lease payments were as follows (in thousands):
SCHEDULE OF FUTURE MINIMUM LEASE PAYMENTS
As of December 31,
2025
585
2026
507
2027
493
2028
133
2029
7
Total lease payments
1,725
Less: Imputed interest
( 213 )
Total
$ 1,512
NOTE
12 – COMMITMENTS AND CONTINGENCIES
There
were no new material commitments or contingencies entered into during the year ended December 31, 2024 and 2023.
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 December 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
Calculation of Numerator:
Net loss
$ ( 11,136 )
( 13,583 )
Loss applicable to common stockholders
$ ( 11,136 )
$ ( 13,583 )
Calculation of Denominator:
Weighted average number of shares of Common Stock outstanding
5,019,886
1,219,381
Net loss per share of Common Stock (basic and diluted)
$ ( 2.22 )
$ ( 11.14 )
As
of December 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
2024
2023
Common stock warrants
9,658
2,821
Common stock options
1,238
127
Total
10,896
2,948
- 98 -
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, we consider the principal or most advantageous market in which it transacts and
considers assumptions that market participants would use when pricing the asset or liability. We apply 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
As of December 31, 2024 and 2023,
the fair value of our 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.
Recurring Fair Value Measurements
For the years ended December
31, 2024 and 2023, we did not have any assets and liabilities classified as Level 1, Level 2 or Level 3. We 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 during 2023, this liability was reclassified to additional paid-in-capital on November 2,
2023.
The following table represents
a reconciliation of our liabilities measured at fair value on a recurring basis using significant unobservable inputs (Level 3) for the
year ended December 31, 2023:
SCHEDULE
OF FAIR VALUE LIABILITIES ON RECURRING BASIS
Warrant Liability
(In thousands)
Beginning balance, January 1, 2023
$ -
Issuance of warrants
14,453
Exercise of warrants
( 2,847 )
Change in fair value upon re-measurement
( 10,875 )
Reclassification of warrant liabilities to additional paid-in-capital
( 731 )
Ending balance, December 31, 2023
$ -
- 99 -
We re-measured the liability
to estimate fair value at November 2, 2023 as a result of the amendment described above, using the Black-Scholes option pricing model
with the following assumptions:
SCHEDULE
OF FAIR VALUE PRICING MODEL
January 9, 2023
March 31, 2023
June 30, 2023
September 30, 2023
November 2, 2023
Measurement date closing price of Common Stock (1)
$ 36.00
$ 8.50
$ 12.75
$ 4.75
$ 3.62
Contractual term (years) (2)
5.5
5.3
5.0
4.8
5.0
Risk-free interest rate
3.6 %
3.5 %
4.1 %
4.5 %
4.6 %
Volatility
100 %
100 %
100 %
100 %
100 %
Dividend yield
0 %
0 %
0 %
0 %
0 %
(1)
Based on the trading value of common stock of
Vivos Therapeutics, Inc. as of January 9, 2023 and each presented period ending date.
(2)
The valuation of warrants is based on the expected
term.
Our 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. As of the years ended December 31, 2024, and 2023 we had no transfers of its assets or liabilities between levels of the
fair value hierarchy.
Significant Concentrations
Credit Risk
We maintain our cash and cash
equivalents primarily in depository and money market accounts within three large financial institutions in the United States. Cash balances
deposited at these major financial banking institutions exceed the insured limits. We have not experienced any losses on its bank deposits
and believe these deposits do not expose us to any significant credit risk. If we 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 December 31, 2024, we had cash
and cash equivalents with three financial institutions in the United States with an aggregate balance of $ 6.3 million.
Generally, credit risk with respect
to accounts receivable is diversified due to the number of entities comprising our customer base and their dispersion across different
geographies and industries. We perform ongoing credit evaluations on certain customers and generally do not require collateral on accounts
receivable. No single customer represented more than 10% of our sales or accounts receivable as of December 31, 2024. We maintain reserves
for potential bad debts.
Supplier Concentration
As previously disclosed, we rely
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 December 31, 2024, we had five suppliers that accounted for approximately 57 % of our total purchases during
the year. We expect to maintain existing relationships with these vendors.
NOTE 15 – SEGMENT INFORMATION
We operate our business as one
operating segment. An operating segment is defined as a component of an enterprise for which separate discrete financial information
is available and evaluated regularly by CODM in deciding how to allocate resources and in assessing performance. Our CODM is the Company’s
Chief Executive Officer, and Chair of the Board of Directors. Reportable segment information is consistent with how management reviews
the business, makes investing and resource allocation decisions and assesses operating performance. Our segment revenues are derived
from the sales of our products, and services, the Vivos Method, to sleep centers and VIP providers in the U.S., Canada, Australia and
in select countries in Europe and Asia.
- 100 -
Our CODM uses consolidated revenue,
gross profit, gross margin and operating loss as the measure of profit or loss. Our CODM assesses performance for the segment and allocates
resources and monitors budget versus actual results using consolidated revenue, gross profit, gross margin and operating loss. The monitoring
of budget versus actual results are used in establishing management’s compensation. The measure of segment assets is reported on
the balance sheet as total consolidated assets.
SCHEDULE
OF SEGMENT REPORTING
2024
2023
Year Ended December 31,
2024
2023
Revenue
$ 15,031
$ 13,801
Less: (1)
Cost of sales
6,012
5,530
Gross profit
9,019
8,271
Less: (1)
General and administrative
17,878
22,479
Sales and marketing
1,731
2,467
Operating loss (exclusive of depreciation and amortization shown
separately below)
( 10,590 )
( 16,675 )
Depreciation and amortization
( 581 )
( 621 )
Other expense
( 110 )
( 212 )
Excess warrant fair value
-
( 6,453 )
Change in fair value of warrant liability, net of issuance costs of $ 645
-
10,231
Other income
145
147
Segment net loss
( 11,136 )
( 13,583 )
Reconciliation of profit or loss
Adjustments and reconciling items
-
-
Consolidated net loss
$ ( 11,136 )
$ ( 13,583 )
(1)
The significant expense categories and amounts align with the segment-level
information that is regularly provided to our chief operating decision maker.
Revenue and long-lived tangible assets are all located
in the U.S.
NOTE 16 – SUBSEQUENT EVENTS
- 101 -
Item 9. Changes in and Disagreements with Accountants
on Accounting and Financial Disclosure.
None.