Vivos Therapeutics, Inc.
(“Vivos” or the “Company'') (NASDAQ: VVOS), a medical technology
company focused on developing and commercializing innovative
diagnostic and treatment methods for patients suffering from a
variety of health conditions, many of which are associated with
breathing related sleep issues arising from certain dentofacial
abnormalities, today reported financial results and operating
highlights for the first quarter ended March 31, 2023.
First Quarter 2023 Financial
Highlights
- Revenue was $3.9 million for the
first quarter of 2023, compared to $3.6 million for the first
quarter of 2022, mainly due to higher Vivos Integrated Provider
(“VIP”) enrollments as well as increased revenue from seminars
conducted at the Vivos Institute (readers should note that Vivos’
reported financial results for the three months ended March 31,
2023 and 2022 reflect the application of Vivos’ previously
announced updated ASC 606 revenue recognition policies, including
deferral of a portion of revenue into future periods);
- During the first quarter of 2023,
Vivos enrolled 38 VIPs and recognized VIP revenue of approximately
$1.3 million, an increase of 42% in enrollment revenue, compared to
32 VIPs and approximately $0.9 million for the first quarter of
2022;
- Gross profit was $2.3 million for
the first quarter of 2023, compared to gross profit of $2.6 million
for the first quarter of 2022, attributable to higher costs
associated with increased VIP training as well as the sale and
leasing of SleepImage® home sleep test rings;
- Gross margin was 61% for the first
quarter of 2023, compared to 70% for the first quarter of 2022,
reflecting higher costs associated with VIP training and new
incentives deployed to increase VIP enrollments;
- Operating expenses decreased by a
significant amount ($1.8 million, or 20%) versus the first quarter
of 2022, reflecting Vivos’ previously announced cost-cutting
initiatives. These initiatives, when combined with a $3.2 million
non-cash derivative gain associated with Vivos’ outstanding
warrants, led to a significant year-over-year reduction of net loss
for the quarter;
- In January 2023, Vivos completed a
private placement for net proceeds of approximately $7.4 million to
augment its liquidity position; and
- Cash and cash equivalents were $7.0
million at March 31, 2023.
First Quarter 2023 and Recent Operating
Highlights
- As of March 31 2023, patients
treated with The Vivos Method totaled over 35,000, compared to
approximately 28,000 as of the first quarter of 2022. Vivos has
also trained over 1,750 dentists in the use of The Vivos Method and
Vivos’ related value-added services, compared to more than 1,600 as
of the first quarter 2022;
- In February 2023, Vivos acquired
certain U.S. and international patents, product rights, and other
miscellaneous intellectual property from Advanced Facialdontics,
LLC (“AFD”), a company holding propriety technology with FDA 510(k)
clearances for Temporomandibular Joint Dysfunction (“TMD”) and
Bruxism (unconscious teeth grinding and clenching). With this asset
purchase transaction, Vivos acquired recently issued U.S. patents,
provisional patent applications as well as international patents,
Patent Cooperation Treaty patents and patent applications. One of
Vivos’ key strategic goals for the remainder of 2023 is to initiate
and grow sales of the AFD products, notably the Preventive Oral
Device® (known as The POD®); and
- In May 2023, Vivos announced the
results of a clinical observational study on the application of the
POD® in the treatment and prevention of migraine headaches. The
study demonstrated statistically significant results, with
ninety-two percent (92%) of study patients reporting their migraine
symptoms were completely resolved following completion of
treatment. Migraine headaches affect over 39 million people in the
United States alone according to the American Migraine
Foundation.
“Vivos is evolving into a more scalable and
sustainable growth company with a clear path to cash flow positive
operations. By broadening and diversifying our core product
offerings and giving potential new providers easier and less costly
options to enroll and become Vivos-trained, we believe we are
positioning ourselves to become the comprehensive go-to source for
dental treatments for OSA and other debilitating conditions like
TMD and Bruxism. No other company in our market has the
evidence-based technologies, or the regulatory clearances, or the
clinical and technical expertise, or the full complementary product
line, or the strong brand equity that Vivos has with healthcare
providers and patients,” stated Kirk Huntsman, Vivos’ Chairman and
Chief Executive Officer. “We continue to believe our latest rounds
of cost cutting, the impact of which can be seen in our first
quarter results, coupled with an intense focus on creating
accretive new revenue streams, will allow us to achieve our stated
goal of achieving positive cash flow in the first quarter of
2024.”
“During the first quarter, we continued to make
substantial progress towards realizing our potential. Our focused
sales and marketing efforts are gaining traction and our
organizational changes have made Vivos a more efficient,
streamlined organization. With our expanded products and services
offering, we are well positioned to continue attracting more
dentists and medical professionals to utilize the Vivos Method, as
well as larger organizations, including Durable Medical Equipment
(known as DME) companies and Dental Service Organizations (known as
DSOs), to market and distribute our products. As we seek to drive
revenue growth, Vivos now has new or active pilot programs with
eight different DSO organizations, representing over 1,000 dental
practices, as well as a new pilot program we will be launching
shortly with a nationally regarded DME to distribute our devices.
We are pleased with what we have achieved so far in 2023, and look
forward to continuing this momentum during the rest of the year and
into 2024,” Mr. Huntsman concluded.
Vivos encourages investors and other interested
parties to join its conference call today at 5:00 p.m. Eastern time
(details below), where management will discuss further details on
topics including: (i) the acquisition of product rights and patents
from AFD and Vivos’ expanded product line and revenue potential,
(ii) the potential significant impact of Vivos’ recent discussions
with DME companies on Vivos’ near-term growth, (iii) an update on
Vivos’ DSO and DME sales and marketing efforts; (iv) additional
programs for dentists to enroll with Vivos, and (v) Vivos’ current
cash position and actions taken to reduce cash burn.
In addition, further information on Vivos’
financial results is included on the attached condensed
consolidated balance sheets and statements of operations, and
additional explanations of Vivos’ financial performance are
provided in the Vivos’ Quarterly Report on Form 10-Q for the three
months ended March 31, 2023, which will be filed with the
Securities and Exchange Commission (“SEC”). The full 10-Q report
will be available on the SEC Filings section of the Investor
Relations section of Vivos’ website at
https://vivos.com/investor-relations.
Conference Call
To access Vivos’ investor conference call,
please dial (877) 451-6152, or for international callers, (201)
389-0879. A replay will be available shortly after the call and can
be accessed by dialing (844) 512-2921, or for international
callers, (412) 317-6671. The passcode for the live call and the
replay is 13739119. The replay will be available until June 22,
2023.
A live webcast of the conference call can be
accessed on Vivos’ website at https://vivos.com/investor-relations.
An online archive of the webcast will be available on the Company’s
website for 30 days following the call.
About Vivos Therapeutics,
Inc.
Vivos Therapeutics, Inc. (NASDAQ: VVOS) is a
medical technology company focused on developing and
commercializing innovative diagnostic and treatment methods for
patients suffering from breathing and sleep issues arising from
certain dentofacial abnormalities such as mild-to-moderate
obstructive sleep apnea (OSA) and snoring in adults. The Vivos
Method represents the first clinically effective nonsurgical,
noninvasive, nonpharmaceutical and cost-effective solution for
treating mild to moderate OSA. It has proven effective in over
35,000 patients treated worldwide by more than 1,750 trained
dentists.
The Vivos Method includes the Vivos Complete
Airway Repositioning and/or Expansion (CARE) appliance therapy and
associated protocols that alter the size, shape and position of the
soft tissues that comprise a patient’s upper airway and/or palate.
The Vivos Method opens airway space and may significantly reduce
symptoms and conditions associated with mild-to-moderate OSA, such
as lowering Apnea Hypopnea Index scores. Vivos also markets and
distributes SleepImage diagnostic technology under its VivoScore
program for home sleep testing in adults and children. The Vivos
Integrated Practice (VIP) program offers dentists training and
other value-added services in connection with using The Vivos
Method.
For more information, visit
www.vivos.com.
Cautionary Note Regarding
Forward-Looking 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
“may”, “should”, “expects”, “projects,” “intends”, “plans”,
“believes”, “anticipates”, “hopes”, “estimates”, “goal” and
variations of such words and similar expressions are intended to
identify forward-looking statements. These statements involve
significant known and unknown risks and are based upon several
assumptions and estimates, which are inherently subject to
significant uncertainties and contingencies, many of which are
beyond Vivos’ control. Actual results (including, without
limitation, the results of Vivos’ sales, marketing and cost cutting
initiatives as described herein) may differ materially from those
expressed or implied by such forward-looking statements. Factors
that could cause actual results to differ materially include, but
are not limited to risk factors described in Vivos’ filings with
the Securities and Exchange Commission (“SEC”). Vivos’ filings can
be obtained free of charge on the SEC’s website at www.sec.gov.
Except to the extent required by law, Vivos expressly disclaims any
obligations or undertaking to release publicly any updates or
revisions to any forward-looking statements contained herein to
reflect any change in Vivos’ expectations with respect thereto or
any change in events, conditions, or circumstances on which any
statement is based.
Vivos Investor Relations
Contact:Julie GannonInvestor Relations
Officer720-442-8113jgannon@vivoslife.com
-Tables Follow-
VIVOS THERAPEUTICS INC. |
|
Unaudited Condensed Consolidated Balance
Sheets |
|
(In Thousands, Except Per Share
Amounts) |
|
|
|
|
|
March 31,2023 |
|
|
December 31,2022 |
|
|
|
|
|
|
|
|
Current assets |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
7,046 |
|
|
$ |
3,519 |
|
Accounts receivable, net of allowance of $672 and $712,
respectively |
|
|
321 |
|
|
|
457 |
|
Prepaid expenses and other current assets |
|
|
1,346 |
|
|
|
1,448 |
|
|
|
|
|
|
|
|
|
|
Total current assets |
|
|
8,713 |
|
|
|
5,424 |
|
|
|
|
|
|
|
|
|
|
Long-term
assets |
|
|
|
|
|
|
|
|
Goodwill |
|
|
2,843 |
|
|
|
2,843 |
|
Property and equipment, net |
|
|
3,157 |
|
|
|
3,082 |
|
Operating lease right-of-use asset |
|
|
1,621 |
|
|
|
1,695 |
|
Intangible assets, net |
|
|
458 |
|
|
|
302 |
|
Deposits and other |
|
|
308 |
|
|
|
374 |
|
|
|
|
|
|
|
|
|
|
Total assets |
|
$ |
17,100 |
|
|
$ |
13,720 |
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
|
|
Current
liabilities |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
1,495 |
|
|
$ |
1,411 |
|
Accrued expenses |
|
|
1,940 |
|
|
|
1,912 |
|
Warrant liability |
|
|
1,333 |
|
|
|
- |
|
Current portion of contract liabilities |
|
|
2,647 |
|
|
|
2,926 |
|
Current portion of operating lease liability |
|
|
433 |
|
|
|
419 |
|
Other current liabilities |
|
|
127 |
|
|
|
145 |
|
|
|
|
|
|
|
|
|
|
Total current liabilities |
|
|
7,975 |
|
|
|
6,813 |
|
|
|
|
|
|
|
|
|
|
Long-term
liabilities |
|
|
|
|
|
|
|
|
Contract liabilities, net of current portion |
|
|
250 |
|
|
|
112 |
|
Operating lease liability, net of current portion |
|
|
1,882 |
|
|
|
1,994 |
|
|
|
|
|
|
|
|
|
|
Total liabilities |
|
|
10,107 |
|
|
|
8,919 |
|
|
|
|
|
|
|
|
|
|
Commitments and
contingencies |
|
|
- |
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
Stockholders’
equity |
|
|
|
|
|
|
|
|
Preferred Stock, $0.0001 par value per share. Authorized 50,000,000
shares; no shares issued and outstanding |
|
|
- |
|
|
|
- |
|
Common Stock, $0.0001 par value per share. Authorized 200,000,000
shares; issued and outstanding 29,928,786 shares as of March 31,
2023 and 23,012,119 shares as December 31, 2022 |
|
|
3 |
|
|
|
2 |
|
Additional paid-in capital |
|
|
88,161 |
|
|
|
84,267 |
|
Accumulated deficit |
|
|
(81,171 |
) |
|
|
(79,468 |
) |
Total stockholders’ equity |
|
|
6,993 |
|
|
|
4,801 |
|
Total liabilities and stockholders’ equity |
|
$ |
17,100 |
|
|
$ |
13,720 |
|
VIVOS THERAPEUTICS INC. |
|
Unaudited Condensed Consolidated Statements of
Operations |
|
(In Thousands, Except Per Share Amounts) |
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
|
2023 |
|
|
2022 |
|
Revenue |
|
|
|
|
|
|
Product revenue |
|
$ |
1,772 |
|
|
$ |
2,049 |
|
Service revenue |
|
|
2,085 |
|
|
|
1,595 |
|
Total revenue |
|
|
3,857 |
|
|
|
3,644 |
|
|
|
|
|
|
|
|
|
|
Cost of sales (exclusive of depreciation and amortization shown
separately below) |
|
|
1,520 |
|
|
|
1,093 |
|
|
|
|
|
|
|
|
|
|
Gross profit |
|
|
2,337 |
|
|
|
2,551 |
|
|
|
|
|
|
|
|
|
|
Operating expenses |
|
|
|
|
|
|
|
|
General and administrative |
|
|
6,537 |
|
|
|
8,275 |
|
Sales and marketing |
|
|
630 |
|
|
|
753 |
|
Depreciation and amortization |
|
|
175 |
|
|
|
162 |
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
|
7,342 |
|
|
|
9,190 |
|
|
|
|
|
|
|
|
|
|
Operating loss |
|
|
(5,005 |
) |
|
|
(6,639 |
) |
|
|
|
|
|
|
|
|
|
Non-operating income
(expense) |
|
|
|
|
|
|
|
|
Other expense |
|
|
51 |
|
|
|
(38 |
) |
PPP loan forgiveness |
|
|
- |
|
|
|
1,287 |
|
Excess warrant fair value |
|
|
(6,453 |
) |
|
|
|
|
Change in fair value of warrant liability, net of issuance costs of
$645 |
|
|
9,628 |
|
|
|
- |
|
Other income |
|
|
76 |
|
|
|
59 |
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(1,703 |
) |
|
$ |
(5,331 |
) |
|
|
|
|
|
|
|
|
|
Net loss per share (basic and
diluted) |
|
$ |
(0.07 |
) |
|
$ |
(0.25 |
) |
|
|
|
|
|
|
|
|
|
Weighted average number of
shares of Common Stock outstanding (basic and diluted) |
|
|
24,764,041 |
|
|
|
21,233,485 |
|
|
|
|
|
|
|
|
|
|
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