NeuroMetrix Reports Q1 2013 Results
Launch of SENSUS^™ Pain Management Device Highlights the Quarter
WALTHAM, Mass. -- April 25, 2013
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
SENSUS related activity in Q1 included:
*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.
*Sales channel development leading to ten regional DME suppliers.
*Discussions with potential distributors having national footprints that,
if successful, could lead to a substantial increase in product sales.
*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).
*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.
*Important R&D progress including improvements to ease of use, support for
use during sleep, and development of a second generation device.
*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.
NeuroMetrixis 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
billioninthe 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.
Condensed Statements of Operations
Revenues $ 1,401,454 $ 2,081,542
Cost of revenues 569,784 1,134,944
Gross profit 831,670 946,598
Research and development 1,073,419 978,066
Sales and marketing 779,841 1,534,101
General and administrative 1,233,594 1,191,064
Total operating expenses 3,086,854 3,703,231
Loss from operations (2,255,184 ) (2,756,633 )
Interest income 1,769 4,298
Net loss $ (2,253,415 ) $ (2,752,335 )
Net loss per common share data, basic $ (1.06 ) $ (1.99 )
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
March 31, December 31,
Cash and cash equivalents $ 6,886,191 $ 8,699,478
Other current assets 1,741,790 1,873,588
Noncurrent assets 263,221 304,381
Total assets $ 8,891,202 $ 10,877,447
Current liabilities $ 1,939,779 $ 2,005,606
Noncurrent liabilities 55,965 71,419
Stockholders’ equity 6,895,458 8,800,422
Total liabilities and stockholders’ equity $ 8,891,202 $ 10,877,447
Thomas T. Higgins, 781-314-2761
SVP and Chief Financial Officer
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