Vivos Therapeutics, Inc. (“Vivos” or the “Company'') (NASDAQ:
VVOS), a medical technology company focused on developing and
commercializing a suite of innovative diagnostic and treatment
modalities for patients with dentofacial abnormalities and/or mild
to moderate obstructive sleep apnea (OSA) and snoring in adults,
today reported financial results and operating highlights for the
first quarter ended March 31, 2022.
Financial and Operating
Highlights
- Revenue was $3.5 million for the
first quarter of 2022, compared to $3.4 million for the first
quarter of 2021;
- Appliance revenue increased 19% as
Vivos sold 2,965 total oral appliance arches, compared to 2,570 for
the first quarter of 2021;
- Gross profit was $2.4 million for
the first quarter of 2022, compared to gross profit of $2.7 million
for the first quarter of 2021, attributable to higher costs
associated with increased sales volume of our appliances and VIP
enrollments;
- Gross margin was 68% for the first
quarter of 2022, compared to 78% for the first quarter of 2021,
reflecting higher costs associated with appliances and VIP
enrollments;
- Cash and cash equivalents were
$17.8 million at March 31, 2022;
- Operational highlights during the
first quarter of 2022 and subsequent to quarter end included:
- Patients treated with The Vivos
Method totaled approximately 27,000, compared to just over 17,000
as of the first quarter of 2021. Vivos has also trained over 1,500
dentists in the use of The Vivos Method and Vivos’ related
value-added services, compared to just over 1,200 as of the first
quarter of 2021.
- In January 2022, Vivos announced an
18X increase in home sleep tests performed by Vivos-trained
dentists in the fourth quarter of 2021 versus the fourth quarter of
2020.
- Also in January 2022, Vivos filed a
U.S. patent application related to certain new and enhanced
clinical methods and protocols developed within Vivos’ proprietary
Vivos Method treatment for OSA.
- Subsequent to quarter end, in April
Vivos announced the May opening of a third Pneusomnia Sleep Center,
representing joint medical / dental ownership and collaboration
featuring Vivos products and technology in the greater Los Angeles
area. The new facility will join existing Pneusomnia Centers in Del
Mar and Modesto, Calif. The Company expects to open at least four
additional Pneusomnia facilities in 2022.
“While first quarter results were flat compared
to the prior year, we do not believe they reflect improvements that
started in March and are continuing here into the second quarter,”
said R. Kirk Huntsman, CEO. “Despite some January and February
headwinds, as the effects of the pandemic started to wane, March
saw a strong turnaround in key metrics across the board, including
a 28% increase in appliance sales, a 47% increase in home sleep
tests performed by Vivos-trained dentists and exponential growth
across all digital channels from our social media initiatives.”
“In addition, the DSO sales and pilot test
initiatives that we launched in the fourth quarter of 2021 are
exceeding our expectations and creating significant growth
opportunities. Our deep DSO industry relationships and early
success have put us in active discussions for additional pilots
with a number of DSO groups representing well over 5,000 dental
offices in the U.S. and Canada. We consider this a major positive
development that will allow us to scale up the Company much faster
and cost-effectively.”
“In order to position ourselves to fully take
advantage of the significant growth opportunities before us and to
extend our available capital resources, we have proactively made
certain strategic budget and personnel realignments that have
reduced our expenses and allowed us to extend our available
resources, all while bringing on several new seasoned key
executives with deep industry experience and great success scaling
up and operating medical device companies.
“In closing, Vivos continues to make progress
throughout all aspects of our business. As our key initiatives
progress, we expect our recent momentum to be reflected in our
operating results in future quarters, but particularly in the
latter half of this year.”
Vivos encourages investors and other interested
parties to join its quarterly conference call today at 5:00 p.m.
Eastern time (details below), where management will discuss further
details on important topics including: (i) Vivos’ current cash
position and efforts to manage cash flow (ii) the potential
significant impact of Vivos’ DSO sales and marketing campaign
efforts on near-term growth; (iii) recent and anticipated additions
to senior management; (iv) recent Vivos clinical research data and
its implications and (v) and update on Vivos’ marketing strategy
and recent success.
In addition, further information on Vivos’
financial results is included on the attached condensed
consolidated balance sheets and statements of operations, and
additional explanations of Vivos’ financial performance are
provided in the Vivos’ Quarterly Report on Form 10-Q for the three
months ended March 31, 2022, which will be filed with the
Securities and Exchange Commission (“SEC”). The full 10-Q report
will be available on the SEC Filings section of the Investor
Relations section of Vivos’ website at
https://vivos.com/investor-relations.
Business Updates
In January 2022, Vivos announced significant
increases across several key metrics for its SleepImage Home Sleep
Test ring (or HST), including in particular, for the three-months
ended December 31, 2021, versus the three-months ended December 31,
2020: (i) an 18 times increase in the total number of HSTs given
across the VIP network, (ii) a 5.7 times increase in the number of
VIPs administering HSTs and (iii) a 3 times increase in the average
number of HSTs being administered per VIP. Vivos believes this
performance gain in home sleep testing allowed it to renegotiate
its commercial agreement with SleepImage to lower costs and convert
the entire diagnostic program from a loss leader aimed primarily at
stimulating new case starts with sleep apnea treatment using the
Vivos Method to a potential recurring revenue center.
Later in January, Vivos filed a U.S. patent
application related to certain new and enhanced clinical methods
and protocols developed within Vivos’ proprietary Vivos Method
treatment for OSA. The Vivos Method, inclusive of the Vivos System,
seeks to treat dentofacial abnormalities and/or OSA through a
combination of Vivos’ proprietary oral appliances and devices as
well as proprietary clinical methods and protocols. This new patent
application was based on early field data which revealed an
additional 58% average improvement in Apnea Hypopnea Index (AHI)
score reductions in OSA patients who had received treatment with
the Vivos Method where the revised clinical protocols were
implemented.
In March, Vivos announced a rebranding of its
proprietary offering of clinical treatment devices, modalities and
protocols, now called The Vivos Method, to better capture the
multiple ways in which Vivos can help independent dentists treat
their patients. To learn more about The Vivos Method, patients can
visit Vivos’ updated website www.vivos.com to
find:
- Information about OSA and its
corresponding symptoms;
- Testimonials from Vivos-trained
dentists and their patient’s success stories; and
- Opportunities for Vivos
partnerships, FAQs and more.
In addition to simplifying information for
patients visiting the new Vivos website, Vivos now provides
dentists looking to tackle OSA and sleep therapies guidance in
becoming a Vivos Integrated Provider. This turnkey program enables
dentists to elevate patient services and care, while also
increasing the growth potential for practice revenue and
income.
Also in March, Vivos’ Medical Advisory Board
presented new clinical results from retrospective data in patients
using The Vivos Method at the 2022 World Sleep Congress in Rome,
Italy. The World Sleep Congress is one of the largest global
conferences dedicated to sleep medicine research. Dr. Seth Heckman,
MD, gave the presentation to an audience of physicians, dentists,
researchers, and other professionals who gathered to learn about
emerging technologies and therapies within sleep medicine.
Subsequent to quarter end, in April Vivos
announced its medical integration division will open its third U.S.
multidisciplinary sleep apnea clinic (known as a Pneusomnia Sleep
Center) in May 2022 in the greater Los Angeles area. Toluca Lake,
Calif. The new facility will join existing Pneusomnia Centers in
Del Mar and Modesto, Calif. The Center will be a clinician-owned,
Medicare-approved clinic, and will provide a comprehensive array of
services that include The Vivos Method and other treatments for
both adults and children, mandibular advancement devices, laser
treatment, oral myofunctional therapy, home sleep testing and
positive airway pressure (PAP) services.
Conference Call
Vivos senior management will conduct a
conference call today, May 16, 2022 at 5:00 p.m. (Eastern Time) to
review the first quarter results as well as provide an overview of
the Company's recent milestones and growth strategy.
To access the conference call, please dial (888)
256-1007, or for international callers, (720) 543-0214. A replay
will be available shortly after the call and can be accessed by
dialing (844) 512-2921, or for international callers, (412)
317-6671. The passcode for the live call and the replay is 5800759.
The replay will be available until May 30, 2022.
A live webcast of the conference call can be
accessed on Vivos’ website at https://vivos.com/investor-relations.
An online archive of the webcast will be available on the Company’s
website for 30 days following the call.
About Vivos Therapeutics,
Inc.
Vivos Therapeutics Inc. (NASDAQ: VVOS) is a
medical technology company focused on developing and
commercializing innovative diagnostic and treatment methods for
patients suffering from dentofacial abnormalities and/or mild to
moderate sleep apnea (OSA) and snoring in adults. The Vivos Method
represents the first clinically effective non-surgical,
non-invasive, non-pharmaceutical and cost-effective solution and
has proven effective in approximately 27,000 patients treated
worldwide by more than 1,500 trained dentists.
Combining proprietary technologies and
treatments that alter the size, shape and position of the tissues
that comprise a patient’s upper airway, The Vivos Method opens
airway space and may significantly reduce symptoms and conditions
associated with mild to moderate OSA, such as lowering Apnea
Hypopnea Index scores. Vivos also markets and distributes
SleepImage diagnostic technology under its VivoScore program for
Home Sleep Testing in adults and children. The Vivos Integrated
Practice (VIP) program offers dentists training and other
value-added services in connection with using The Vivos Method.
For more information, visit www.vivos.com.
Cautionary Note Regarding
Forward-Looking StatementsThis press release, the
conference call referred to herein, and statements of the Company’s
management made in connection therewith contain “forward-looking
statements” (as defined in Section 27A of the Securities Act of
1933, as amended, and Section 21E of the Securities Exchange Act of
1934, as amended) concerning future events, particularly with
respect to the public offering described herein. Words such as
“aim”, “may”, “could”, “should”, “expects”, “projects,” “intends”,
“plans”, “believes”, “predicts”, “anticipates”, “hopes”,
“estimates” and variations of such words and similar expressions
are intended to identify forward-looking statements. These
statements involve known and unknown risks and are based upon
several assumptions and estimates, which are inherently subject to
significant uncertainties and contingencies, many of which are
beyond Vivos’ control. Actual results may differ materially from
those expressed or implied by such forward-looking statements.
Factors that could cause actual results to differ materially
include, but are not limited to, the risk factors described in
Vivos’ filings with the Securities and Exchange Commission (“SEC”).
Vivos’ filings can be obtained free of charge on the SEC's website
at www.sec.gov. Except to the extent required by law, Vivos
expressly disclaims any obligations or undertaking to release
publicly any updates or revisions to any forward-looking statements
contained herein to reflect any change in Vivos' expectations with
respect thereto or any change in events, conditions, or
circumstances on which any statement is based.
Vivos Investor Relations
Contact:Julie GannonInvestor Relations Officer(303)
859-3847jgannon@vivoslife.com
Vivos Media Relations
Contact:Francesca DeMauro / Jenny RoblesKCSA Strategic
Communications(917) 880-9771 / (212) 896-1231fdemauro@kcsa.com /
jrobles@kcsa.com
-Tables Follow-
VIVOS THERAPEUTICS
INC.Unaudited Consolidated Balance
Sheets(In Thousands, Except Per Share
Amounts)
|
|
March 31, 2022 |
|
|
December 31, 2021 |
|
ASSETS |
|
|
|
|
|
|
|
|
Current
assets |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
17,828 |
|
|
$ |
24,030 |
|
Accounts receivable, net of allowance of $181 and $180,
respectively |
|
|
1,002 |
|
|
|
1,203 |
|
Tenant improvement allowance receivable |
|
|
516 |
|
|
|
516 |
|
Prepaid expenses and other current assets |
|
|
2,255 |
|
|
|
1,575 |
|
|
|
|
|
|
|
|
|
|
Total current assets |
|
|
21,601 |
|
|
|
27,324 |
|
|
|
|
|
|
|
|
|
|
Long-term
assets |
|
|
|
|
|
|
|
|
Goodwill |
|
|
2,843 |
|
|
|
2,843 |
|
Property and equipment, net |
|
|
2,913 |
|
|
|
2,825 |
|
Operating lease right-of-use asset |
|
|
1,514 |
|
|
|
- |
|
Intangible assets, net |
|
|
331 |
|
|
|
341 |
|
Deposits and other |
|
|
354 |
|
|
|
356 |
|
|
|
|
|
|
|
|
|
|
Total assets |
|
$ |
29,556 |
|
|
$ |
33,689 |
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
|
|
Current
liabilities |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
877 |
|
|
$ |
920 |
|
Accrued expenses |
|
|
3,172 |
|
|
|
2,853 |
|
Contract liabilities |
|
|
2,344 |
|
|
|
2,399 |
|
Current portion of long-term debt |
|
|
- |
|
|
|
1,265 |
|
Current portion of operating lease liability |
|
|
357 |
|
|
|
72 |
|
Other current liabilities |
|
|
101 |
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
Total current liabilities |
|
|
6,851 |
|
|
|
7,509 |
|
|
|
|
|
|
|
|
|
|
Long-term
liabilities |
|
|
|
|
|
|
|
|
Operating lease liability, net of current portion |
|
|
1,850 |
|
|
|
641 |
|
|
|
|
|
|
|
|
|
|
Total liabilities |
|
|
8,701 |
|
|
|
8,150 |
|
|
|
|
|
|
|
|
|
|
Commitments and
contingencies |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders’
equity |
|
|
|
|
|
|
|
|
Preferred Stock, $0.0001 par value per share. Authorized 50,000,000
shares; no shares issued and outstanding |
|
|
- |
|
|
|
- |
|
Common Stock, $0.0001 par value per share. Authorized 200,000,000
shares; issued and outstanding 23,012,119 shares as of March 31,
2022 and December 31, 2021 |
|
|
2 |
|
|
|
2 |
|
Additional paid-in capital |
|
|
81,991 |
|
|
|
81,160 |
|
Accumulated deficit |
|
|
(61,138 |
) |
|
|
(55,623 |
) |
Total stockholders’ deficit Total stockholders’ equity |
|
|
20,855 |
|
|
|
25,539 |
|
Total liabilities and stockholders’ deficit Total liabilities and
stockholders’ equity |
|
$ |
29,556 |
|
|
$ |
33,689 |
|
|
|
|
|
|
|
|
|
|
VIVOS THERAPEUTICS
INC.Unaudited Consolidated Statements of
Operations(In Thousands, Except Per Share
Amounts)
|
|
Three Months Ended March 31, |
|
|
|
2022 |
|
|
2021 |
|
Revenue |
|
|
|
|
|
|
|
|
Product revenue |
|
$ |
1,722 |
|
|
$ |
1,387 |
|
Service revenue |
|
|
1,738 |
|
|
|
2,061 |
|
Total revenue |
|
|
3,460 |
|
|
|
3,448 |
|
|
|
|
|
|
|
|
|
|
Cost of sales (exclusive of
depreciation and amortization shown separately below) |
|
|
1,093 |
|
|
|
758 |
|
|
|
|
|
|
|
|
|
|
Gross profit |
|
|
2,367 |
|
|
|
2,690 |
|
|
|
|
|
|
|
|
|
|
Operating expenses |
|
|
|
|
|
|
|
|
General and administrative |
|
|
8,275 |
|
|
|
5,059 |
|
Sales and marketing |
|
|
753 |
|
|
|
860 |
|
Depreciation and amortization |
|
|
162 |
|
|
|
177 |
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
|
9,190 |
|
|
|
6,096 |
|
|
|
|
|
|
|
|
|
|
Operating loss |
|
|
(6,823 |
) |
|
|
(3,406 |
) |
|
|
|
|
|
|
|
|
|
Non-operating income
(expense) |
|
|
|
|
|
|
|
|
Other expense |
|
|
(38 |
) |
|
|
(1 |
) |
PPP loan forgiveness |
|
|
1,287 |
|
|
|
- |
|
Other income |
|
|
59 |
|
|
|
8 |
|
|
|
|
|
|
|
|
|
|
Loss before income taxes |
|
|
(5,515 |
) |
|
|
(3,399 |
) |
Income tax expense |
|
|
- |
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(5,515 |
) |
|
$ |
(3,399 |
) |
|
|
|
|
|
|
|
|
|
Net loss attributable to
common stockholders |
|
$ |
(5,515 |
) |
|
$ |
(3,399 |
) |
|
|
|
|
|
|
|
|
|
Net loss per share
attributable to common stockholders (basic and diluted) |
|
$ |
(0.26 |
) |
|
$ |
(0.19 |
) |
|
|
|
|
|
|
|
|
|
Weighted average number of
shares of Common Stock outstanding (basic and diluted) |
|
|
21,233 |
|
|
|
18,211 |
|
|
|
|
|
|
|
|
|
|
Vivos Therapeutics (NASDAQ:VVOS)
Historical Stock Chart
From Aug 2024 to Sep 2024
Vivos Therapeutics (NASDAQ:VVOS)
Historical Stock Chart
From Sep 2023 to Sep 2024