NanoVibronix, Inc., (NASDAQ: NAOV), a healthcare
device company that produces the UroShield® and PainShield® Surface
Acoustic Wave (SAW) Portable Ultrasonic Therapeutic Devices, today
reported its financial results for the quarter ended June 30, 2021
and provided a business update.
Financial and Business
Highlights
- Revenue increased 18% to $318,000,
which included the first shipment of products to Ultra Pain
Products, Inc. (UPPI) under its amended contract which extended
terms and increased minimum purchase requirements to $8 million
over three years
- Launched OTC pain management
device, PainShield RELIEF
- Submitted request to CMS for
reimbursement code(s) for UroShield and PainShield Plus
- Received registration approval for
UroShield from Therapeutic Goods Administration (TGA) in
Australia
- Balance sheet remains strong with
$5.7 million in cash and $0 long-term debt as of June 30, 2021
“We made great strides in the first half of
2021, accelerating our progress towards full commercialization of
our products with expanded distribution, clearance of regulatory
approvals, the launch of PainShield Plus and the planned launch of
PainShield RELIEF, which is expected to be available
over-the-counter, significantly expanding our addressable market,”
stated Brian Murphy, CEO of NanoVibronix. “Our entire product
portfolio has been redesigned to improve appearance, functionality
and efficiency, and we have submitted patent applications to
protect our intellectual property, both for our existing brands and
technology as well as products under development. Our robust
business model is comprised of innovative products that are
clearing regulatory approvals, a high-quality manufacturing partner
and global distribution channels. Importantly, we believe that we
are operating in a market environment of increasing demand and that
we can continue to grow.”
Murphy continued, “The demand we are
experiencing exceeds our supply across all of the markets we serve
including commercial, insurance and the Veterans Administration
(VA). This demand, combined with the energy of our distributors to
bring our products to market, reinforces our optimism for continued
growth. Given our growing backlog of orders and the submissions we
are making for regulatory approval in new markets, we are actively
searching for additional manufacturers for our products and are
currently engaged with additional contract manufacturers located in
the United Kingdom, Israel, the United States and Mexico to expand
output.”
Murphy continued, “Another development that we
are energized by is our planned entry into the over-the-counter
market with the launch of PainShield RELIEF, a derivative of our
prescription PainShield that we plan to be available without a
clinician’s prescription. Opening availability of our pain
management device to the mass market should greatly expand our
revenue potential and provide us with the opportunity to scale and
leverage our manufacturing and distribution infrastructures.”
“We are aggressively pursuing a reimbursement
code from the Centers for Medicare and Medicaid (CMS), which once
approved should make the devices more broadly available to millions
of Medicare beneficiaries,” added Murphy. “We recently completed
the application process with CMS to receive a reimbursement code
for our UroShield and PainShield Plus devices and have been granted
approval and reimbursement at favorable rates from the Federal
Supply Schedule. We are progressing in this realm as expeditiously
as possible and are encouraged by the trajectory of our
efforts.”
Murphy concluded, “Our balance sheet remains
strong, and we are adequately funded for growth and execution of
our strategic plans. With $5.7 million in cash at the end of the
second quarter and zero debt, we have the capacity to ramp
manufacturing as orders accelerate while continuing to invest in
product development and expand our sales channels.”
Second Quarter 2021 Financial
Summary
Revenues were $318,000 for the second quarter of
2021, up 18% compared with $269,000 for the second quarter of 2020.
The increase was primarily due to increased sales of PainShield
devices to the company’s distributors.
Gross profit was $208,000, or 65% of revenue, in
the second quarter of 2021 compared with $38,000, or 14% of
revenue, in the 2020 period. The increases in gross profit and
gross margin were primarily driven by increased sales of products
to distributors at higher margins and the absence of special
discounts in the 2021 period.
Total operating expenses were $1.2 million in
the second quarter of 2021 compared with $1.5 million in the prior
year period. The decrease was primarily due to a decrease in
general and administrative expense resulting from the inclusion of
a non-recurring settlement with a contractor in the year ago
period, partially offset by an increase in expense in the current
period for fees related to a lawsuit, expenses related to the
company’s efforts to ratify its prior over issuances of common
stock and an increase in salary expense in the 2021 period compared
to the year ago period when salaries were reduced due to the
furlough of staff at the start of the COVID-19 pandemic. The
decreases in general and administrative expenses were partially
offset by an increase in research and development expense and
selling and marketing expense, primarily salary related as the
prior period benefited from the furlough of staff.
Net loss was $216,000, or $(0.01) per basic and
diluted share, compared with a loss of $1.5 million or $(0.20) per
basic and diluted share for the previous quarter. Second quarter
2021 results include a change in fair value of derivative
liabilities resulting in a non-cash gain of $706,000.
About NanoVibronix, Inc.
NanoVibronix, Inc. (NASDAQ: NAOV) is a medical
device company headquartered in Elmsford, New York, with research
and development in Nesher, Israel, focused on developing medical
devices utilizing its patented low intensity surface acoustic wave
(SAW) technology. The proprietary technology allows for the
creation of low-frequency ultrasound waves that can be utilized for
a variety of medical applications, including for disruption of
biofilms and bacterial colonization, as well as for pain relief.
The devices can be administered at home without the assistance of
medical professionals. The Company’s primary products include
PainShield® and UroShield®, which are portable devices suitable for
administration at home without assistance of medical professionals.
Additional information about NanoVibronix is available at:
www.nanovibronix.com.
Forward-looking Statements
This press release contains “forward-looking
statements.” Such statements may be preceded by the words
“intends,” “may,” “will,” “plans,” “expects,” “anticipates,”
“projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,”
“potential” or similar words. Forward-looking statements are not
guarantees of future performance, are based on certain assumptions
and are subject to various known and unknown risks and
uncertainties, many of which are beyond the Company’s control, and
cannot be predicted or quantified; consequently, actual results may
differ materially from those expressed or implied by such
forward-looking statements. Such risks and uncertainties include,
without limitation, risks and uncertainties associated with: (i)
the geographic, social and economic impact of COVID-19 on the
Company’s ability to conduct its business and raise capital in the
future when needed, (ii) market acceptance of our existing and new
products or lengthy product delays in key markets; (iii) negative
or unreliable clinical trial results; (iv) inability to secure
regulatory approvals for the sale of our products; (v) intense
competition in the medical device industry from much larger,
multinational companies; (vi) product liability claims; (vii)
product malfunctions; (viii) our limited manufacturing capabilities
and reliance on subcontractor assistance; (ix) insufficient or
inadequate reimbursements by governmental and/or other third party
payers for our products; (x) our ability to successfully obtain and
maintain intellectual property protection covering our products;
(xi) legislative or regulatory reform impacting the healthcare
system in the U.S. or in foreign jurisdictions; (xii) our reliance
on single suppliers for certain product components, (xiii) the need
to raise additional capital to meet our future business
requirements and obligations, given the fact that such capital may
not be available, or may be costly, dilutive or difficult to
obtain; (xiv) our conducting business in foreign jurisdictions
exposing us to additional challenges, such as foreign currency
exchange rate fluctuations, logistical and communications
challenges, the burden and cost of compliance with foreign laws,
and political and/or economic instabilities in specific
jurisdictions; and (xv) market and other conditions. More detailed
information about the Company and the risk factors that may affect
the realization of forward looking statements is set forth in the
Company’s filings with the Securities and Exchange Commission
(SEC), including the Company’s Annual Report on Form 10-K and its
Quarterly Reports on Form 10-Q. Investors and security holders are
urged to read these documents free of charge on the SEC’s web site
at: http://www.sec.gov. The Company assumes no obligation to
publicly update or revise its forward-looking statements as a
result of new information, future events, or otherwise, except as
required by law.
-- Tables Follow –
NanoVibronix,
Inc.Condensed Consolidated Balance Sheets
(Unaudited)(Amounts in thousands, except share and
per share data)
|
|
|
|
|
|
|
June 30, 2021 |
|
|
December 31, 2020 |
|
ASSETS: |
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
Cash and cash equivalents |
$ |
5,672 |
|
|
$ |
7,142 |
|
Restricted cash |
|
- |
|
|
|
391 |
|
Trade receivables |
|
36 |
|
|
|
25 |
|
Other accounts receivable and prepaid expenses |
|
671 |
|
|
|
267 |
|
Inventory |
|
205 |
|
|
|
145 |
|
Total current assets |
|
6,584 |
|
|
|
7,970 |
|
|
|
|
|
|
|
|
|
Non-current assets: |
|
|
|
|
|
|
|
Fixed assets, net |
|
5 |
|
|
|
4 |
|
Other assets |
|
23 |
|
|
|
25 |
|
Severance pay fund |
|
198 |
|
|
|
199 |
|
Operating lease right-of-use assets, net |
|
22 |
|
|
|
31 |
|
Total non-current assets |
|
248 |
|
|
|
259 |
|
Total assets |
$ |
6,832 |
|
|
$ |
8,229 |
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
Trade payables |
$ |
181 |
|
|
$ |
144 |
|
Other accounts payable and accrued expenses |
|
147 |
|
|
|
488 |
|
Deferred revenues |
|
53 |
|
|
|
- |
|
Shares issued in excess of authorized |
|
- |
|
|
|
2,257 |
|
Operating lease liabilities - current |
|
10 |
|
|
|
13 |
|
Total current liabilities |
|
391 |
|
|
|
2,902 |
|
|
|
|
|
|
|
|
|
Non-current liabilities: |
|
|
|
|
|
|
|
Accrued severance pay |
$ |
241 |
|
|
|
245 |
|
Deferred licensing income |
|
176 |
|
|
|
199 |
|
Derivative liabilities |
|
1,848 |
|
|
|
2,471 |
|
Operating lease liabilities, non-current |
|
12 |
|
|
|
18 |
|
Total liabilities |
|
2,668 |
|
|
|
5,835 |
|
|
|
|
|
|
|
|
|
Commitments and contingencies
(Note 9) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
|
|
Series C Preferred stock of $0.001 par value - Authorized:
3,000,000 shares at June 30, 2021 and December 31, 2020; Issued and
outstanding: 666,667 at June 30, 2021 and December 31, 2020 |
|
1 |
|
|
|
1 |
|
|
|
|
|
|
|
|
|
Series D Preferred stock of $0.001 par value - Authorized: 506
shares at June 30, 2021 and December 31, 2020; Issued and
outstanding: 153 at June 30, 2021 and December 31, 2020 |
|
- |
|
|
|
- |
|
|
|
|
|
|
|
|
|
Series E Preferred stock of $0.001 par value - Authorized:
1,999,494 shares at June 30, 2021 and December 31, 2020,
respectively; Issued and outstanding: 875,000 at June 30, 2021 and
December 31, 2020 |
|
1 |
|
|
|
1 |
|
|
|
|
|
|
|
|
|
Common stock of $0.001 par value - Authorized: 24,109,635 shares at
June 30, 2021 and December 31, 2020; Issued and outstanding:
24,109,634 and 21,246,523 shares at June 30, 2021 and December 31,
2020, respectively |
|
24 |
|
|
|
22 |
|
|
|
|
|
|
|
|
|
Additional paid in
capital |
|
51,867 |
|
|
|
44,959 |
|
Accumulated other
comprehensive income |
|
59 |
|
|
|
66 |
|
Accumulated deficit |
|
(47,788 |
) |
|
|
(42,655 |
) |
Total stockholders’ equity |
|
4,164 |
|
|
|
2,394 |
|
Total liabilities and stockholders’ equity |
$ |
6,832 |
|
|
$ |
8,229 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NanoVibronix,
Inc.Condensed Consolidated Statements of
Operations (Unaudited)(Amounts in thousands except
share and per share data)
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
|
2021 |
|
|
2020 |
|
|
2021 |
|
|
2020 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues |
$ |
318 |
|
|
$ |
269 |
|
|
$ |
421 |
|
|
$ |
383 |
|
Cost of revenues |
|
110 |
|
|
|
231 |
|
|
|
136 |
|
|
|
294 |
|
Gross profit |
|
208 |
|
|
|
38 |
|
|
|
285 |
|
|
|
89 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
64 |
|
|
|
16 |
|
|
|
128 |
|
|
|
63 |
|
Selling and marketing |
|
296 |
|
|
|
180 |
|
|
|
607 |
|
|
|
434 |
|
General and administrative |
|
839 |
|
|
|
1,310 |
|
|
|
1,855 |
|
|
|
1,967 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
1,199 |
|
|
|
1,506 |
|
|
|
2,590 |
|
|
|
2,464 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations |
|
(991 |
) |
|
|
(1,468 |
) |
|
|
(2,305 |
) |
|
|
(2,375 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Financial income (expense), net |
|
1 |
|
|
|
(5 |
) |
|
|
(6 |
) |
|
|
(10 |
) |
Change in fair value of derivative liabilities |
|
706 |
|
|
|
- |
|
|
|
(1,242 |
) |
|
|
- |
|
Gain on purchase of warrants |
|
64 |
|
|
|
- |
|
|
|
64 |
|
|
|
- |
|
Warrant modification expense |
|
- |
|
|
|
- |
|
|
|
(1,627 |
) |
|
|
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss before taxes on
income |
|
(220 |
) |
|
|
(1,473 |
) |
|
|
(5,116 |
) |
|
|
(2,385 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income tax benefit / (expense) |
|
4 |
|
|
|
(4 |
) |
|
|
(17 |
) |
|
|
(13 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
$ |
(216 |
) |
|
$ |
(1,477 |
) |
|
$ |
(5,133 |
) |
|
$ |
(2,398 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss
available for holders of common stock, Series C Preferred Stock and
Series D Preferred Stock |
$ |
(0.01 |
) |
|
$ |
(0.20 |
) |
|
$ |
(0.21 |
) |
|
$ |
(0.33 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average common shares
outstanding: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted |
|
24,776,302 |
|
|
|
7,252,510 |
|
|
|
24,476,551 |
|
|
|
7,279,708 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Investor Contacts:
Brett Maas, Managing Principal, Hayden IR,
LLCbrett@haydenir.com(646) 536-7331
SOURCE: NanoVibronix, Inc.
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