NeuroMetrix, Inc. (the “Company”) (Nasdaq: NURO), today reported
business highlights for the quarter ended June 30, 2014.
The Company operates in two primary markets - wearable medical
technology and point-of-care tests. The Company's SENSUS device is a
wearable transcutaneous electrical nerve stimulator indicated for
management of chronic pain, and is the only such device cleared by the
FDA for use during sleep. It is lightweight and can be worn during the
day while remaining active, and at night while sleeping. SENSUS is
beneficial in treating various forms of chronic pain, particularly
neuropathic pain such as painful diabetic neuropathy, which affects
about one quarter of people with diabetes. The Company's point-of-care
neuropathy test, DPNCheck, addresses an unmet medical need for accurate
and cost-effective screening, diagnosing and monitoring of peripheral
neuropathies such as diabetic peripheral neuropathy. DPNCheck has found
growing acceptance among Medicare Advantage plans where it is used in
the clinically and financially important risk adjustment process.
DPNCheck is being introduced into the Japan and China markets through a
partnership with Omron Healthcare.
The Company reported recent highlights:
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Substantial progress was made in development of the Company’s
consumer-oriented chronic pain treatment product. Most importantly,
FDA clearance was received for over-the-counter sales of the device.
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SENSUS device sales increased to 1,707 devices in Q2 2014 from 208
devices in Q2 2013 and 1,448 devices in Q1 2014.
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DPNCheck received regulatory approval in Japan. Omron Healthcare, with
active NeuroMetrix support, initiated DPNCheck marketing at the Japan
Diabetes Society annual meeting in May.
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A regulatory application for DPNCheck was submitted in China.
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DPNCheck sales increased to 24,325 tests in Q2 2014 from 8,100 tests
in Q2 2013 and 18,025 tests in Q1 2014.
-
Worldwide revenue from SENSUS and DPNCheck increased to $0.62 million
in Q2 2014 from $0.16 million reported in Q2 2013, nearly a four-fold,
year-over-year increase.
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The Company's legacy ADVANCE business, which is managed for cash flow,
continued to generate contributory funding with an estimated $0.37
million in gross profit in Q2 2014.
-
An $8.0 million equity offering was closed during the quarter.
“FDA clearance for over-the-counter sales of our wearable technology for
treating chronic pain was a significant milestone in a busy, productive
quarter,” said Shai N. Gozani, M.D., Ph.D., President and Chief
Executive Officer of NeuroMetrix. “The positive reaction we’ve seen to
SENSUS, and recent market research, indicates a substantial consumer
market for a differentiated over-the-counter product. This is an
opportunity we intend to exploit and are devoting substantial resources
toward a commercial launch in 2015.”
The Company reported its financial results for Q2 2014. Total revenues
were $1.34 million, up 16% from $1.16 million for Q2 2013. Gross profit
was 51.2 percent of total revenues compared to 56.8 percent in Q2 2013.
Operating expenses were $3.3 million compared to $2.8 million in Q2
2013. The Company recorded a non-cash credit of $0.5 million at June 30,
2014 for the revaluation at fair value of outstanding common stock
warrants compared to $1.2 million revaluation credit at June 30, 2013.
Net loss was $2.2 million, or $0.85 per share. This compared to a net
loss of $1.3 million for Q2 2013, or $0.92 per share. NeuroMetrix
reported net cash usage of $2.0 million and ended the period with cash
resources of $13.7 million.
For the six month period ended June 30, 2014, the Company reported
revenues of $2.7 million and a net loss of $3.4 million, or $1.06 per
share. In the comparable six month period ended June 30, 2013, the
Company recorded revenues of $2.6 million and a net loss of $3.6
million, or $1.97 per share.
Company to Host Live Conference Call and Webcast
NeuroMetrix management will host a conference call today, July 24, 2014
at 8:00 a.m., Eastern. To access the call in the United States, dial
877-415-3181 and use the confirmation code 36035520. Internationally,
the conference call may be accessed by dialing 857-244-7324 and using
the same confirmation code. The call will also be webcast and will be
accessible from the Company's website at http://www.NeuroMetrix.com/
under the "Investor Relations" tab. A replay of the conference call will
be available starting two hours after the call by dialing 888-286-8010,
domestically and 617-801-6888, internationally. The confirmation code to
access the replay is 86288051. The replay will be available for two
weeks after the conference call.
About NeuroMetrix
NeuroMetrix is an innovative health-care company that develops wearable
medical technology and point-of-care tests that help patients and
physicians better manage chronic pain, nerve diseases, and sleep
disorders. The Company has a major focus on diabetic neuropathies, which
affect over 50% of people with diabetes. If left untreated, diabetic
neuropathies trigger foot ulcers that may require amputation and cause
disabling chronic pain. The annual cost of diabetic neuropathies has
been estimated at $14 billion in the United States. The Company markets
the SENSUS device for treating chronic pain, focusing on physicians
managing patients with painful diabetic neuropathy and other forms of
chronic pain such as fibromyalgia, shingles (post herpetic neuralgia),
and conditions involving both chronic pain and disturbed sleep such as
restless leg syndrome. The Company also markets DPNCheck, which is a
rapid, accurate, and quantitative point-of-care test for peripheral
neuropathies such as diabetic neuropathy. This product is used to detect
neuropathies at an early stage and to guide treatment. For more
information, please visit http://www.NeuroMetrix.com.
Safe Harbor Statement
The statements contained in this press release include forward-looking
statements within the meaning of Section 27A of the Securities Act of
1933, as amended, and Section 21E of the Securities Exchange Act of
1934, as amended, including, without limitation, statements regarding
the company’s or management’s expectations relating to the adoption of
SENSUS and NC-stat DPNCheck, our ability to build a successful business
focused on diabetic and adjacent neuropathies, our hope of expanding our
commercial sales channels for our products and our hope of expanding
SENSUS national distribution to rapidly expand SENSUS awareness and
sales. While the company believes the forward-looking statements
contained in this press release are accurate, there are a number of
factors that could cause actual events or results to differ materially
from those indicated by such forward-looking statements, including,
without limitation, our estimates of future performance, and our ability
to successfully develop, receive regulatory clearance or approval,
commercialize and achieve market acceptance for any of our products.
There can be no assurance that future developments will be those that
the company has anticipated. Such forward-looking statements involve
known and unknown risks, uncertainties and other factors including those
risks, uncertainties and factors referred to in the company’s most
recent Annual Report on Form 10-K as well as other documents that may be
filed from time to time with the Securities and Exchange Commission or
otherwise made public. The company is providing the information in this
press release only as of the date hereof, and expressly disclaims any
intent or obligation to update the information included in this press
release or revise any forward-looking statements.
|
NeuroMetrix, Inc.
|
Condensed Statements of Operations
|
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
Quarters Ended June 30,
|
|
|
Six Months Ended June 30,
|
|
|
|
|
2014
|
|
|
2013
|
|
|
2014
|
|
|
2013
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues
|
|
|
$
|
1,343,770
|
|
|
$
|
1,160,472
|
|
|
$
|
2,675,307
|
|
|
$
|
2,561,926
|
|
Cost of revenues
|
|
|
655,337
|
|
|
501,161
|
|
|
1,270,418
|
|
|
1,070,945
|
|
Gross profit
|
|
|
688,433
|
|
|
659,311
|
|
|
1,404,889
|
|
|
1,490,981
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
1,464,834
|
|
|
913,847
|
|
|
2,328,551
|
|
|
1,987,266
|
|
Sales and marketing
|
|
|
694,664
|
|
|
880,218
|
|
|
1,140,880
|
|
|
1,660,059
|
|
General and administrative
|
|
|
1,148,278
|
|
|
992,160
|
|
|
2,295,035
|
|
|
2,225,754
|
|
Total operating expenses
|
|
|
3,307,776
|
|
|
2,786,225
|
|
|
5,764,466
|
|
|
5,873,079
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations
|
|
|
(2,619,343
|
)
|
|
(2,126,914
|
)
|
|
(4,359,577
|
)
|
|
(4,382,098
|
)
|
Interest income
|
|
|
990
|
|
|
1,394
|
|
|
2,026
|
|
|
3,163
|
|
Other expense
|
|
|
(27,618
|
)
|
|
(376,306
|
)
|
|
(27,618
|
)
|
|
(376,306
|
)
|
Warrants fair value adjustment
|
|
|
475,261
|
|
|
1,155,996
|
|
|
989,861
|
|
|
1,155,996
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
$
|
(2,170,710
|
)
|
|
$
|
(1,345,830
|
)
|
|
$
|
(3,395,308
|
)
|
|
$
|
(3,599,245
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share applicable to common stock, basic and diluted
|
|
|
$
|
(0.85
|
)
|
|
$
|
(0.92
|
)
|
|
$
|
(1.06
|
)
|
|
$
|
(1.97
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Note: per share amounts have been adjusted to reflect the Company’s 1:6
reverse stock-split which occurred on February 15, 2013.
|
|
Condensed Balance Sheets
|
(Unaudited)
|
|
|
|
|
June 30,
2014
|
|
|
December 31,
2013
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
|
$
|
13,693,792
|
|
|
$
|
9,195,753
|
Other current assets
|
|
|
1,486,829
|
|
|
1,370,774
|
Noncurrent assets
|
|
|
181,085
|
|
|
230,236
|
Total assets
|
|
|
$
|
15,361,706
|
|
|
$
|
10,796,763
|
|
|
|
|
|
|
|
Current liabilities
|
|
|
$
|
2,372,589
|
|
|
$
|
1,647,908
|
Noncurrent liabilities
|
|
|
5,378,804
|
|
|
1,953,879
|
Stockholders’ equity
|
|
|
7,610,313
|
|
|
7,194,976
|
Total liabilities and stockholders’ equity
|
|
|
$
|
15,361,706
|
|
|
$
|
10,796,763
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Copyright Business Wire 2014