Expanded Distribution, Entry into New
Geographic Markets and Regulatory Approvals Advancing Efforts
Towards Full Commercialization
NanoVibronix, Inc., (NASDAQ: NAOV), a medical device company
utilizing the Company's proprietary and patented low intensity
surface acoustic wave (SAW) technology, today reported its
financial results for the quarter ended March 31, 2022.
First Quarter 2022 Financial and Recent Business Highlights
- Revenue of $272,000, an increase of 164% compared to the prior
year period
- Significant backlog of orders to be filled in Q2
- Supply chain challenges are expected to abate moving into the
second half of 2022
- Submitted a 510(k) application to the U.S. Food and Drug
Administration (FDA) for PainShield® MD PLUS
- Engaged a prominent researcher to facilitate a “gold standard”
study for UroShield to submit to FDA for full 510k clearance
- Received published recommendation guidance from the National
Institute for Health and Care Excellence (NICE) to advance efforts
to achieve NHS approval of UroShield
- Received licensing approval from Health Canada / Santé Canada
for PainGuard and UroGuard
- Signed a Provider Agreement with EZ Health Care to advance
position in workers’ compensation market
- Continued to broaden the PainShield footprint in the VA system
nationwide through Delta Medical
- Entered into an International Marketing, Sales and Clinical
Management Agreement with leading commercialization firm to extend
reach of UroShield and PainSheild
- Filed three U.S. patent applications related to SAW technology
and indwelling medical devices
- Expanded Board of Directors with appointment of two new
independent directors
- Balance sheet remains strong with $6.0 million in cash and $0
long-term debt as of March 31, 2022
“We continued our efforts to expand distribution of our products
through new partnerships in the workers’ compensation market and by
securing regulatory approvals both domestically and in the U.K. and
Canada,” stated Brian Murphy, CEO of Nanovibronix, Inc. “First
quarter sales were up significantly year-over-year despite
component sourcing challenges that caused a delay in first quarter
order shipments of approximately $300,000. We expect that the delay
will only impact the timing of revenue recognition as demand for
our products remains robust. We continue to improve our approved
reimbursement channels and are working to further enhance them
going forward. We believe our manufacturing is stable, and we do
not expect our supply chain to be an issue for the remainder of the
year.”
Murphy added, “Our balance sheet remains strong with $6.0
million in cash on hand and zero debt at the end of the first
quarter of 2022. We believe we are in a solid position to fund our
growth and continue to advance our products towards full
commercialization. We continue to be optimistic about the future of
NanoVibronix.”
First Quarter 2022 Financial Summary
Revenues were $272,000 for the first quarter of 2022, up 164%
compared with $103,000 for the first quarter of 2021. The increase
was primarily due to increased orders from the Company’s largest
customer as well as the addition of selling to veteran affairs
facilities, which was limited to available finished goods.
Gross profit was $106,000, or 39.0% of revenue, in the first
quarter of 2022 compared with $77,000, or 74.8% of revenue, in the
2021 period. The increase in gross profit was primarily driven by
sales to veteran affairs facilities and sales of products to
distributors at higher margins.
Total operating expenses were $1.2 million in the first quarter
of 2022 compared with $1.4 million in the prior year period. The
decrease was mainly due to a decrease in selling and marketing
expense due to decreased salaries and a decrease in options
expense.
Net loss was $1.1 million for the first quarter of 2022 compared
with a net loss of $4.9 million for the previous quarter. The
three-month period ended March 31, 2021 included a non-cash loss of
$1.9 million related to a change in the fair value of derivative
liabilities and a non-cash loss of $1.6 million of warrant
modification expense related to warrants held by a certain investor
that were repriced.
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.
NanoVibronix, Inc.
Condensed Consolidated Balance
Sheets
(Amounts in thousands except
share and per share data)
March 31, 2022
(Unaudited)
December 31, 2021
(Audited)
ASSETS:
Current assets:
Cash and cash equivalents
$
5,990
$
7,737
Trade receivables
134
200
Other accounts receivable and prepaid
expenses
911
230
Inventory
355
175
Total current assets
7,390
8,342
Non-current assets:
Fixed assets, net
5
5
Other assets
17
19
Severance pay fund
207
207
Operating lease right-of-use assets,
net
44
49
Total non-current assets
273
280
Total assets
$
7,663
$
8,622
LIABILITIES AND STOCKHOLDERS’
EQUITY:
Current liabilities:
Trade payables
$
172
$
87
Other accounts payable and accrued
expenses
1,747
1,723
Deferred revenues
44
44
Operating lease liabilities - current
44
49
Total current liabilities
2,007
1,903
Non-current liabilities:
Accrued severance pay
253
253
Deferred licensing income
142
153
Total liabilities
2,402
2,309
Commitments and contingencies
Stockholders’ equity:
Series C Preferred stock of $0.001 par
value - Authorized: 3,000,000 shares at both March 31, 2022 and
December 31, 2021; Issued and outstanding: 0 at both March 31, 2022
and December 31, 2021
-
-
Series D Preferred stock of $0.001 par
value - Authorized: 506 shares at both March 31, 2022 and December
31, 2021; Issued and outstanding: 0 at both March 31, 2022 and
December 31, 2021
-
-
Series E Preferred stock of $0.001 par
value - Authorized: 1,999,494 shares at both March 31, 2022 and
December 31, 2021; Issued and outstanding: 0 at both March 31, 2022
and December 31, 2021
-
-
Common stock of $0.001 par value -
Authorized: 40,000,000 shares at March 31, 2022 and December 31,
2021, respectively; Issued and outstanding: 27,997,793 shares at
March 31, 2022 and December 31, 2021,
28
28
Additional paid in capital
63,248
63,162
Accumulated other comprehensive income
54
60
Accumulated deficit
(58,069
)
(56,937
)
Total stockholders’ equity
5,261
6,313
Total liabilities and stockholders’
equity
$
7,663
$
8,622
NanoVibronix, Inc.
Condensed Consolidated
Statements of Operations and Comprehensive Loss (Unaudited)
(Amounts in thousands except
share and per share data)
Three Months Ended March
31,
2022
2021
Revenues
$
272
$
103
Cost of revenues
166
26
Gross profit
106
77
Operating expenses:
Research and development
66
64
Selling and marketing
210
311
General and administrative
942
1,016
Total operating expenses
1,218
1,391
Loss from operations
(1,112
)
(1,314
)
Financial income (expense), net
(13
)
(7
)
Change in fair value of derivative
liabilities
-
(1,948
)
Warrant modification expense
-
(1,627
)
Loss before taxes on income
(1,125
)
(4,896
)
Income tax expense
(7
)
(21
)
Net loss
$
(1,132
)
$
(4,917
)
Basic and diluted net loss available for
holders of common stock, Series C Preferred Stock and Series D
Preferred Stock
$
(0.04
)
$
(0.20
)
Weighted average common shares
outstanding:
Basic and diluted
27,997,793
24,170,065
Comprehensive loss:
Net loss available to common
stockholders
(1,132
)
(4,917
)
Change in foreign currency translation
adjustments
(4
)
6
Comprehensive loss
(1,136
)
(4,911
)
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220517005289/en/
Investor Contacts: Brett Maas, Managing Principal, Hayden IR,
LLC brett@haydenir.com (646) 536-7331
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