Momentum Continues with Solid Execution of
Product Commercialization Strategy
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 September 30, 2021.
Third Quarter Financial and Business Highlights
- Revenue of $499,000, an increase of 233% compared to the prior
year period
- Introduced CBD gel for topical treatment of pain and in
combination with PainShield, to product line-up
- Expanded total addressable market with entry into worker's
compensation market through agreement with one of the largest
national payers
- Backlog of orders in excess of $600,000 as of September 30,
2021
- Balance sheet remains strong with $8.6 million in cash and $0
long-term debt as of September 30, 2021
“We are increasingly encouraged by the progress we believe we
are making towards broad adoption and commercialization of our
products,” stated Brian Murphy, CEO of NanoVibronix. “As of
September 30, we had a backlog of orders that exceeded this
quarter’s revenue, a telling metric that demonstrates growing sales
throughput of our product and revenue to be recognized in the
future. Looking beyond year end, we have commitments to deliver a
more significant quantity of product than ever before and an
improved contract manufacturing position that we expect will enable
a significant increase in product delivery through the first
quarter of 2022.
“Potential near term catalysts for our business include the
recent launch of our first non-prescription device, PainShield
Relief, for the mass consumer market, adoption of UroShield by the
National Healthcare Service (NHS) in the U.K., expanded sales
distribution as we enter the Canadian and Middle Eastern markets
and increasing adoption of our products through our existing
distributor network and finalizing CMS reimbursement for PainShield
and UroShield, all of which we believe are advancing towards
effectiveness later this year and early in 2022,” Murphy added.
Murphy continued, “Given the current macro environment, we are
working diligently to strengthen and optimize our inventory
position by exploring additional componentry sources and
manufacturing alternatives. In doing so, we are also identifying
opportunities to rationalize our cost of goods and potentially
improve unit economics on future sales as our business scales.”
Murphy concluded, “Our balance sheet remains strong with $8.6
million in cash on hand and zero debt at the end of the third
quarter. We are in a solid position to fund our growth and continue
to advance our products towards full commercialization.”
Third Quarter 2021 Financial Summary
Revenues were $499,000 for the third quarter of 2021, up 233%
compared with $150,000 for the third quarter of 2020. The increase
was primarily due to increased sales of PainShield devices as a
result of new distribution agreements, including one new
distributor that sells product to Veterans Administration (VA)
facilities.
Gross profit was $228,000, or 46% of revenue, in the third
quarter of 2021 compared with $99,000, or 66% of revenue, in the
2020 period. The increase in gross profit was primarily driven by
higher sales while the decline in gross profit margin was the
result of increased costs of manufacturing and shipping compared to
last year.
Total operating expenses were $1.1 million in the third quarter
of 2021 compared with $903,000 in the prior year period. The 10.7%
increase was the result of an increase in general and
administrative expense, primarily professional fees related to the
company’s special shareholder meeting and the addition of two new
employees in the 2021 period compared to the prior year period.
Net loss was $6.7 million, or $(0.26) per basic and diluted
share, compared with a net loss of $922,000 or $(0.10) per basic
and diluted share for the previous quarter. Third quarter 2021
results include a change in fair value of derivative liabilities
resulting in a non-cash loss of $5.7 million.
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 (Unaudited)
(Amounts in thousands, except
share and per share data)
September 30, 2021
December 31, 2020
ASSETS:
Current assets:
Cash and cash equivalents
$
8,599
$
7,142
Restricted cash
-
391
Trade receivables
28
25
Other accounts receivable and prepaid
expenses
597
267
Inventory
201
145
Total current assets
9,425
7,970
Non-current assets:
Fixed assets, net
6
4
Other assets
16
25
Severance pay fund
199
199
Operating lease right-of-use assets,
net
20
31
Total non-current assets
241
259
Total assets
$
9,666
$
8,229
LIABILITIES AND STOCKHOLDERS’
EQUITY:
Current liabilities:
Trade payables
$
62
$
144
Other accounts payable and accrued
expenses
194
488
Shares issued in excess of authorized
-
2,257
Operating lease liabilities - current
10
13
Total current liabilities
266
2,902
Non-current liabilities:
Accrued severance pay
$
243
245
Deferred licensing income
165
199
Deferred revenue
271
-
Derivative liabilities
-
2,471
Operating lease liabilities,
non-current
10
18
Total liabilities
955
5,835
Commitments and contingencies (Note 9)
Stockholders’ equity:
Series C Preferred stock of $0.001 par
value - Authorized: 3,000,000 shares at September 30, 2021 and
December 31, 2020; Issued and outstanding: 666,667 at September 30,
2021 and December 31, 2020
1
1
Series D Preferred stock of $0.001 par
value - Authorized: 506 shares at September 30, 2021 and December
31, 2020; Issued and outstanding: 153 at September 30, 2021 and
December 31, 2020
-
-
Series E Preferred stock of $0.001 par
value - Authorized: 1,999,494 shares at September 30, 2021 and
December 31, 2020, respectively; Issued and outstanding: 0 at
September 30, 2021 and 875,000 at December 31, 2020
1
1
Common stock of $0.001 par value -
Authorized: 40,000,000 shares at September 30, 2021 and 24,109,634
at December 31, 2020; Issued and outstanding: 27,178,126 and
21,246,523 shares at September 30, 2021 and December 31, 2020,
respectively
27
22
Additional paid in capital
63,086
44,959
Accumulated other comprehensive income
59
66
Accumulated deficit
(54,463
)
(42,655
)
Total stockholders’ equity
8,711
2,394
Total liabilities and stockholders’
equity
$
9,666
$
8,229
NanoVibronix, Inc.
Condensed Consolidated Statements
of Operations (Unaudited)
(Amounts in thousands except
share and per share data)
Three Months Ended September
30,
Nine Months Ended September
30,
2021
2020
2021
2020
Revenues
$
499
$
150
$
920
$
533
Cost of revenues
271
51
407
345
Gross profit
228
99
513
188
Operating expenses:
Research and development
50
68
178
131
Selling and marketing
245
289
852
723
General and administrative
801
546
2,656
2,513
Total operating expenses
1,096
903
3,686
3,367
Loss from operations
(868
)
(804
)
(3,173
)
(3,179
)
Interest expense
-
(123
)
-
(123
)
Financial income (expense), net
(23
)
(15
)
(29
)
(25
)
Change in fair value of derivative
liabilities
(5,714
)
-
(6,956
)
-
Gain on purchase of warrants
-
-
64
-
Warrant modification expense
-
-
(1,627
)
-
Loss before taxes on income
(6,605
)
(942
)
(11,721
)
(3,327
)
Income tax benefit / (expense)
(70
)
20
(87
)
7
Net loss
$
(6,675
)
$
(922
)
$
(11,808
)
$
(3,320
)
Basic and diluted net loss available for
holders of common stock, Series C Preferred Stock and Series D
Preferred Stock
$
(0.26
)
$
(0.10
)
$
(0.47
)
$
(0.43
)
Weighted average common shares
outstanding:
Basic and diluted
26,096,957
9,344,254
25,014,919
7,649,242
Comprehensive loss:
Net loss available to common
stockholders
(6,675
)
(922
)
(11,808
)
(3,320
Change in foreign currency translation
adjustments
1
-
(7
)
-
Comprehensive loss available to common
stockholders
(6,674
)
(922
)
(11,815
)
(3,320
)
View source
version on businesswire.com: https://www.businesswire.com/news/home/20211116005528/en/
Investor Contact: Brett Maas, Managing Principal, Hayden IR, LLC
brett@haydenir.com (646) 536-7331
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