NeuroMetrix,
Inc. (Nasdaq: NURO), a medical device company focused on the
treatment of diabetic peripheral neuropathy (DPN), today reported
business and financial highlights for the first quarter ended March 31,
2013. DPN is the most common complication of diabetes, affecting over
half of people with the disease. DPN causes neuropathic pain and is the
primary trigger for diabetic foot ulcers which may require lower
extremity amputations.
In the first quarter, the Company launched its first therapeutic
product, the SENSUS Pain Management System. SENSUS is a transcutaneous
electrical nerve stimulator intended for the symptomatic relief and
management of chronic intractable pain. It is the only device designed
specifically for people with chronic neuropathic pain. The most common
cause of such pain in people with diabetes is painful diabetic
neuropathy (PDN), which affects 3 to 5 million patients in the US alone.
Most patients with PDN have moderate to severe pain and half have sleep
disturbances due to their pain. SENSUS offers physicians and their
patients a non-narcotic pain relief option as a complement to
medications. The device is lightweight, can be worn during the day, and
may be used at bedtime before going to sleep. It is activated by the
press of a single button.
SENSUS related activity in Q1 included:
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Initial commercial shipments of 145 SENSUS devices during the quarter.
Feedback from patients has been encouraging with reports of a
substantial decrease in pain and improved sleep.
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Sales channel development leading to ten regional DME suppliers.
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Discussions with potential distributors having national footprints
that, if successful, could lead to a substantial increase in product
sales.
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Design and preparation of a post-market 6-week open-label evaluation
of pain relief in patients with moderate to severe PDN using SENSUS.
The primary outcome measure is a statistically significant improvement
in the pain and interference scores on the Brief Pain Inventory (BPI).
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Filing of a 510(k) for expanded indications relating to device use
during sleep. The current device may be used at bedtime prior to
sleep. This 510(k) submission, if successful, will give SENSUS unique
regulatory labeling for electrical stimulation during sleep.
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Important R&D progress including improvements to ease of use, support
for use during sleep, and development of a second generation device.
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Launch of a SENSUS website with disease information and product
support for patients, physicians, and distributors.
NC-stat® DPNCheck® is the Company’s fast,
accurate, quantitative and cost effective test for DPN. In the US, the
product is primarily marketed to Medicare Advantage insurers and
providers for risk assessment and early clinical intervention. During
the quarter, the international footprint for DPNCheck® was
expanded in Asia with distribution agreements for South Korea with
Handok Pharmaceuticals and for Japan with Omron Healthcare.
“The launch of our first therapeutic product was an important milestone
for NeuroMetrix,” said Shai N. Gozani, M.D., Ph.D., President and Chief
Executive Officer of NeuroMetrix. “We were pleased at the positive early
response to SENSUS from patients, physicians and our distributors.
Although we recognize that we are in the early days of this important
product launch, we are encouraged by our initial market experience.”
The Company reported its financial results for the first quarter of
2013. Total revenues were $1.4 million compared with $2.1 million for
the first quarter of 2012. Diabetes products contributed revenue of
$348,000 with the balance of $1,053,000 in revenue derived from the
legacy ADVANCE™ business. Gross profit for the first quarter
of 2013 was 59.3 percent of total revenues compared to 45.5 percent
gross margin reported in the first quarter of 2012 which period included
an excess inventory charge of $194,000. Operating expenses for the first
quarter of 2013 were $3.1 million compared to $3.7 million in the first
quarter of 2012. Net loss for the first quarter of 2013 was $2.3 million
or $1.06 per share. The Company reported a net loss of $2.8 million for
the first quarter of 2012 or $1.99 per share. NeuroMetrix reported net
cash usage of $1.8 million in the first quarter of 2013 and ended the
period with cash resources of $6.9 million. Per share amounts have been
adjusted for the effects of the February 2013 reverse split.
Company to Host Live Conference Call and Webcast
NeuroMetrix management will host a conference call today, April 25, 2013
at 8:00 a.m., Eastern time. To access the call, dial 866-202-0886
(domestic), or 617-213-8841 (international). The confirmation code is
21617951. 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 for three months starting two hours after the call by
dialing 888-286-8010 (domestic) or 617-801-6888 (international), and the
confirmation code is 67770533.
About NeuroMetrix
NeuroMetrix is a medical device company that develops and markets home
use and point-of-care devices for the treatment of 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™ Pain Management System for
treating chronic pain, focusing on physicians managing patients with
painful diabetic neuropathy and similar peripheral neuropathies. The
company also markets the NC-stat® DPNCheck® device,
which is a rapid, accurate, and quantitative point-of-care test for
diabetic neuropathy. This product is used to detect diabetic neuropathy
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
NC-stat DPNCheck and SENSUS, our ability to build a successful business
focused on diabetic peripheral neuropathy, and our hope of expanding our
commercial sales channel of our diabetic neuropathy products. 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.
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NeuroMetrix, Inc.
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Condensed Statements of Operations
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(Unaudited)
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Quarters Ended March 31,
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2013
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2012
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Revenues
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$
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1,401,454
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$
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2,081,542
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Cost of revenues
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569,784
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1,134,944
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Gross profit
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831,670
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946,598
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Operating expenses:
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Research and development
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1,073,419
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978,066
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Sales and marketing
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779,841
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1,534,101
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General and administrative
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1,233,594
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1,191,064
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Total operating expenses
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3,086,854
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3,703,231
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Loss from operations
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(2,255,184
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(2,756,633
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Interest income
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1,769
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4,298
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Net loss
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$
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(2,253,415
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$
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(2,752,335
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Net loss per common share data, basic and diluted
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$
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(1.06
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$
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(1.99
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Note: per share amounts have been adjusted to reflect the Company’s
1:6 reverse stock-split which occurred on February 15, 2013.
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Condensed Balance Sheets
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(Unaudited)
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March 31,
2013
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December 31,
2012
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Cash and cash equivalents
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$
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6,886,191
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$
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8,699,478
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Other current assets
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1,741,790
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1,873,588
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Noncurrent assets
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263,221
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304,381
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Total assets
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$
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8,891,202
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$
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10,877,447
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Current liabilities
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$
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1,939,779
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$
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2,005,606
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Noncurrent liabilities
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55,965
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71,419
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Stockholders’ equity
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6,895,458
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8,800,422
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Total liabilities and stockholders’ equity
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$
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8,891,202
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$
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10,877,447
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