Gaining Traction with Increased Distribution
and Lower Cost Manufacturing
NanoVibronix, Inc., (NASDAQ: NAOV), a medical device company
that produces the UroShield®, PainShield® and WoundShield® Surface
Acoustic Wave (SAW) Portable Ultrasonic Therapeutic Devices, today
reported its financial results for the quarter ended September 30,
2020 and provided a business update.
Financial and Business Highlights
- Revenue increased 49% to $150,000
- Expanded offerings with introduction of PainShield Plus
- Received U.S. Food and Drug Administration (FDA) authorization
for entry of UroShield into the U.S. during the Covid-19
pandemic
- Completed first shipments of UroShield devices to the United
Kingdom
- Signed a two-year agreement for the distribution of PainShield
devices and components by Durable Medical Equipment (DME)
distributors throughout the United States
- Expanded license agreement for distribution of UroShield and
PainShield in Canada and Turkey
- Secured Medicare reimbursement code from Centers for Medicare
and Medicaid Services (CMS) for PainShield
- Received the coveted Plus X Award 2020 for its PainShield PT
100 ultrasound therapy device in the categories of high quality,
design, ease of use and functionality
- Strengthened balance sheet with approximately $4.1 million in
aggregate net proceeds from two offerings of common stock
“Across the company, we are making great strides towards broader
commercialization of our offerings with new and expanded
distribution agreements, lower cost manufacturing, clearance of
regulatory hurdles and marketing and branding programs that
collectively we believe could elevate our business to the next
level in the near term and create a strong catalyst for additional
growth and broader market penetration,” stated Brian Murphy, CEO of
NanoVibronix.
“In the third quarter we delivered increased revenue as a direct
result of recently signed agreements,” added Murphy. “At the same
time, our sales team is working diligently on a number of
potentially new commercial distributor and licensing agreements
that represent significant promise for incremental revenue and the
opportunity to diversify our revenue sources. In addition, our
products have been added to the U.S. Veterans’ Administration
Federal Supply Schedule (FSS) and are now reimbursable under CMS
Medicare reimbursement codes creating a pathway for expanded
distribution through government channels.”
Murphy concluded, “The resurgence in Covid-19 cases further
reinforces that need for alternative pain therapies that can be
administered safely and remotely, despite the uncertainty and
potential near-term challenges that may also arise as a result of
the global pandemic. Regardless, we continue to execute on our
strategy and pursue promising opportunities to expand our reach and
establish a framework for long-term growth and attractive returns
for our shareholders.”
Third Quarter 2020 Financial Summary
Revenues were $150,000 for the third quarter of 2020, up 49%
compared with $101,000 for the third quarter of 2019. The increase
was primarily due to increased sales to the company’s
distributors.
Gross profit was $99,000, or 66% of revenue, in the third
quarter of 2020 compared with $47,000, or 47% of revenue, in the
2019 period. The increases in gross profit and gross margin were
primarily driven by more advantageous pricing with the company’s
distributors as opposed to discounts given in the prior period.
Total operating expenses were $903,000 in the third quarter of
2020 compared with $840,000 in the prior year period. The increase
was primarily due to an increase in selling and marketing expense
as a result of the restarting of marketing programs.
Net loss was $922,000, or $(0.10) per basic and diluted share,
compared with a loss of $815,000 or $(0.12) per basic and diluted
share for the previous quarter. The loss in the third quarter of
2020 includes interest expense of $123,000 compared with $0 in the
prior year period. Interest expense in the current period is due
primarily to amortization of the full cost of warrants associated
with a note payable that was paid in full during the third quarter
of 2020.
Balance Sheet
The Company ended the quarter with $3.2 million in cash and cash
equivalents, reflecting the two offerings of common stock completed
during the quarter, raising net proceeds of $4.1 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®,
UroShield® and WoundShield®, all of 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, and include, among others, statements regarding the
completion of the public offering, the satisfaction of customary
closing conditions related to the public offering and the intended
use of net proceeds from the public offering; 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, e.g., 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)
September 30, 2020
December 31, 2019
ASSETS:
Current assets:
Cash and cash equivalents
$
3,181
$
1,338
Restricted cash
350
Trade receivables
103
111
Other accounts receivable and prepaid
expenses
161
268
Inventory
109
121
Total current assets
3,904
1,838
Non-current assets:
Fixed assets, net
2
4
Other assets
33
-
Severance pay fund
163
194
Total non-current assets
198
198
Total assets
$
4,102
$
2,036
LIABILITIES AND STOCKHOLDERS’
EQUITY:
Current liabilities:
Trade payables
$
89
$
129
Other accounts payable and accrued
expenses
261
280
Notes payable
14
-
Total current liabilities
364
409
Non-current liabilities:
Accrued severance pay
228
279
Deferred licensing income
215
-
Notes payable, non-current
28
-
Total liabilities
835
688
Commitments and contingencies (Note 9)
Stockholders’ equity:
Series C Preferred stock of $0.001 par
value - Authorized: 3,000,000 shares at September 30, 2020 and
December 31, 2019; Issued and outstanding: 2,502,252 and 2,993,142
at September 30, 2020 and December 31, 2019, respectively
2
2
Series D Preferred stock of $0.001 par
value - Authorized: 506 shares at September 30, 2020 and December
31, 2019; Issued and outstanding: 153 and 304 at September 30, 2020
and December 31, 2019, respectively
-
-
Series E Preferred stock of $0.001 par
value - Authorized: 1,999,494 shares at September 30, 2020 and
December 31, 2019, respectively; Issued and outstanding: 875,000
and 1,825,000 at September 30, 2020 and December 31, 2019,
respectively
2
2
Common stock of $0.001 par value -
Authorized: 20,000,000 shares at September 30, 2020 and December
31, 2019; Issued and outstanding: 12,493,653 and 4,203,764 shares
at September 30, 2020 and December 31, 2019, respectively
12
5
Additional paid in capital
44,901
39,669
Accumulated deficit
(41,650
)
(38,330
)
Total stockholders’ equity
3,267
1,348
Total liabilities and stockholders’
equity
$
4,102
$
2,036
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,
2020
2019
2020
2019
Revenues
$
150
$
101
$
533
$
443
Cost of revenues
51
54
345
136
Gross profit
99
47
188
307
Operating expenses:
Research and development
68
79
131
381
Selling and marketing
289
228
723
820
General and administrative
546
533
2,513
3,018
Total operating expenses
903
840
3,367
4,219
Loss from operations
(804
)
(793
)
(3,179
)
(3,912
)
Interest expense
(123
)
-
(123
)
-
Financial income (expense), net
(15
)
(20
)
(25
)
(71
)
Change in fair value of derivative
liabilities
-
-
-
102
Loss on extinguishment of derivative
liability
-
-
-
(288
)
Warrant modification expense
-
-
-
(412
)
Loss before taxes on income
(942
)
(813
)
(3,327
)
(4,581
)
Income tax benefit / (expense)
20
(2
)
7
(20
)
Net loss
$
(922
)
$
(815
)
$
(3,320
)
$
(4,601
)
Basic and diluted net loss available for
holders of common stock, Series C Preferred Stock and Series D
Preferred Stock
$
(0.10
)
$
(0.12
)
$
(0.43
)
$
(0.66
)
Weighted average common shares
outstanding:
Basic and diluted
9,344,254
7,054,845
7,649,242
7,094,547
View source
version on businesswire.com: https://www.businesswire.com/news/home/20201116006067/en/
Investor Contacts:
NanoVibronix, Inc. bmurphy@nanovibronix.com (630) 338-5022
Or:
Brett Maas, Managing Principal, Hayden IR, LLC
brett@haydenir.com (646) 536-7331
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