UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 


 

FORM 8-K

 

CURRENT REPORT

 

Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934

 


 

Date of Report (Date of earliest event reported):  February 10, 2009

 

NEUROMETRIX, INC.

(Exact name of registrant as specified in charter)

 

Delaware

 

000-50856

 

04-3308180

(State or Other
Jurisdiction
of Incorporation)

 

(Commission File Number)

 

(IRS Employer
Identification No.)

 

62 Fourth Avenue
Waltham, Massachusetts  02451

(Address of Principal Executive Offices)  (Zip Code)

 

(781) 890-9989
(Registrant’s telephone number, including area code)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

o            Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

o            Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

o            Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

o            Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 

 



 

Item 2.02                                             Results of Operations and Financial Condition.

 

On February 10, 2009, NeuroMetrix, Inc. issued a press release announcing its financial results for the three and twelve-month periods ended December 31, 2008.  The full text of the press release and the related attachments are furnished as Exhibit 99.1 hereto and incorporated herein by reference.

 

Item 9.01.                                          Financial Statements and Exhibits.

 

(d)                                 Exhibits.

 

Exhibit No.

 

Description

 

 

 

99.1

 

Press Release of NeuroMetrix, Inc. dated February 10, 2009, including attachments.

 

 

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SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

 

 

NEUROMETRIX, INC.

 

 

 

 

Dated: February 10, 2009

By:

/s/ Shai N. Gozani, M.D., Ph.D.

 

Shai N. Gozani, M.D., Ph.D.

 

President and Chief Executive Officer

 

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EXHIBIT INDEX

 

Exhibit No.

 

Description

 

 

 

99.1

 

Press Release of NeuroMetrix, Inc. dated February 10, 2009, including attachments.

 

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EXHIBIT 99.1

 

NeuroMetrix, Inc. Reports Total Revenues of $7.2 Million for the Fourth Quarter of 2008

WALTHAM, Mass.—(BUSINESS WIRE)—February 10, 2009—NeuroMetrix, Inc. (Nasdaq: NURO), a science-based medical device company advancing patient care through the development and commercialization of innovative products that aid physicians in the assessment, treatment, and repair of peripheral nerve and spinal cord injuries and disorders, and that provide regional anesthesia and pain control, announced today its financial results for the three- and twelve-month periods ended December 31, 2008.

 

Total revenues for the three months ended December 31, 2008, the Company’s fourth quarter, were $7.2 million, compared with $9.8 million for the fourth quarter of 2007, representing a decline of 27%.  During the three-month periods ended December 31, 2008 and 2007, 86% and 92% of revenues, respectively, were derived from consumables sales, 14% and 8% of revenues, respectively, were derived from medical equipment sales. The Company ceased selling and servicing its DigiScopeÔ product as of the end of October 2008 and as a result has recast its financial statements for both years to include the DigiScope sales and expenses as discontinued operations.  Medical equipment sales include sales of ADVANCEÔ devices and related modules and NC-statÒ devices and related modules. Consumables sales include sales of nerve specific electrodes, UNIVERSALÔ electrodes, and EMG needles.

 

Total revenues for the twelve months ended December 31, 2008 were $31.1 million, compared with $43.7 million for the twelve months ended December 31, 2007, representing a decline of 29%.  During the twelve-month periods ended December 31, 2008 and December 31, 2007, 91% and 90% of revenues, respectively were derived from consumable sales, 9% and 10% of revenues, respectively, were derived from medical equipment sales.

 

The costs of revenues as a percentage of total revenues for the fourth quarter of 2008 were 32.2%, compared with 27.1% for the fourth quarter of 2007. In the fourth quarter of 2008, the costs of revenues as a percentage of total revenues increased primarily due to greater discounting. The increased discounting which resulted in lower average selling prices is, in part, related to ADVANCE transition pricing for customers who are specialist physicians with peripheral nerve expertise.

 

The costs of revenues as a percentage of total revenues for the twelve months ended December 31, 2008 was 29.0%, compared with 26.0% for the twelve months ended December 31, 2007. For the twelve months ended December 31, 2008, the costs of revenues as a percentage of total revenues increased due to greater discounting resulting in lower average selling prices as discussed above.

 

The net loss for the fourth quarter of 2008 was approximately $4.1 million, including a charge of $3.7 million resulting from the Company’s previously announced settlement with the U.S. Department of Justice (the “DOJ”) and the Office of the Inspector General of the U.S. Department of Health and Human Services (the “OIG”), a write-down of $274,000 of the Company’s investment in Cyberkinetics

 

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Neurotechnology Systems Inc., a gain of $352,000 on discontinued operations resulting from the sale of the Company’s former DigiScope business, and a gain of $131,000 resulting from the dissolution of the Company’s joint venture and collaboration agreement with Cyberkinetics Neurotechnology Systems, Inc. compared with a net loss of approximately $2.1 million for the fourth quarter of 2007.

 

The net loss for the twelve month period ended December 31, 2008 was $27.7 million, including a loss of $6.6 million from discontinued operations, a goodwill impairment charge of $5.8 million relating to the DigiScope business, a charge of $3.7 million resulting from the Company’s previously announced settlement with the DOJ and OIG, and write-down of $2.5 million of the Company’s investment in Cyberkinetics, compared with a net loss of $8.4 million for the twelve month period ended December 31, 2007.

 

Basic and diluted net loss per share was $(0.30) for the three months ended December 31, 2008 compared with basic and diluted net loss per share of $(0.17) for the three months ended December 31, 2007.  Basic and diluted net loss per share was $(2.02) for the twelve months ended December 31, 2008, compared with basic and diluted net loss per share of $(0.66) for the twelve months ended December 31, 2007.

 

Cash and cash equivalents and short-term investments totaled $19.8 million as of December 31, 2008 compared with $29.7 million as of December 31, 2007.

 

Shai N. Gozani, M.D., Ph.D., NeuroMetrix’s President & CEO commented, “Our revenues in the fourth quarter of 2008 were down approximately 27% from the same period in 2007 primarily due to the continued uncertainty surrounding reimbursement for the NC-stat System and the 40% reduction in our direct sales force in the second quarter of 2008.  During the last quarter, our active customer count, which is a twelve-month look back at accounts utilizing our neurodiagnostic instruments, decreased by 140 to 5,189 physician practices and clinics as of the end of the fourth quarter of 2008 from the third quarter of 2008.  The average consumables usage per active customer also decreased during the fourth quarter of 2008 from the prior quarter.”

 

Dr. Gozani added, “We recently commented on reports that the American Medical Association (AMA) CPT Editorial Panel will establish a Category I CPT code for nerve conduction studies performed with pre-configured electrode arrays, such as are utilized by our NC-stat System. We are encouraged by this direction and believe that this CPT code, when issued, could streamline the process for obtaining reimbursement for nerve conduction studies performed using the NC-stat System.  The amount of reimbursement from Medicare that physicians will receive under this CPT code remains to be determined.  Further, medically appropriate indications for this code may be defined through local and national Medicare medical policies.  In this respect, we are encouraged that multiple Medicare fiscal intermediaries have previously determined that the nerve conduction studies performed with the NC-stat System are covered services.    We expect that the operational characteristics of the NC-stat business will change when physicians begin utilizing the new code in 2010, but look forward to the associated challenges and opportunity to stabilize and eventually return the NC-stat business to growth.”

 

“We are now actively marketing the ADVANCE System into the neurology, physical medicine and rehabilitation (PM&R), neurosurgery, orthopedic and hand surgery, and pain medicine markets through

 

2



 

our direct sales organization.  As of the end of the fourth quarter of 2008, 6% of our active customers were using ADVANCE.  We are encouraged by market reaction and have gained important insight into certain product enhancements that we believe could accelerate adoption.”

 

Dr. Gozani further stated, “We recently announced the acquisition of certain technological and intellectual property assets from Cyberkinetics Neurotechnology Systems, Inc.  This acquisition includes all rights and regulatory filings for the Andara™ Oscillating Field Stimulator (OFS™), which is a novel investigational device for the treatment of acute spinal cord injury.  In connection with the acquisition, we also dissolved our joint venture with Cyberkinetics and acquired certain of the technological and intellectual property assets that Cyberkinetics had contributed to the joint venture.  This acquisition has the potential to diversify our business and help us become a leading neurotechnology company.”

 

Company to Host Live Conference Call and Webcast

 

The Company’s management team will host a live conference call and webcast at 10:00 a.m. Eastern time on Tuesday, February 10, 2009 to discuss the Company’s financial results for the three-month and twelve-month periods ending December 31, 2008. In addition, the Company may answer questions concerning business and financial developments and trends, and other business and financial matters affecting the Company. The conference call may be accessed in the United States by dialing 866-700-0133 and using the confirmation code 50402181. Internationally, the conference call may be accessed by dialing 617-213-8831 and using the same confirmation code. The webcast, along with the earnings press release and accompanying condensed financial statements, will be accessible from the Company’s website at www.neurometrix.com under the “Investor Relations” tab and a replay of the webcast will be available on the Company’s website. 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 17398674. The replay will be available for three months after the conference call.

 

About NeuroMetrix

 

NeuroMetrix is a science-based medical device company advancing patient care through the development and commercialization of innovative products that aid physicians in the assessment, treatment, and repair of peripheral nerve and spinal cord injuries and disorders, and that provide regional anesthesia and pain control. To date, our focus has been primarily on the assessment of neuropathies. Neuropathies affect the peripheral nerves and parts of the spine and are frequently caused by or associated with carpal tunnel syndrome, diabetes, sciatica, and other clinical disorders. We market systems for the performance of nerve conduction studies and needle electromyography procedures. Our product pipeline includes a system designed to deliver pharmacologic agents such as anesthetics and corticosteroids in close proximity to nerves for regional anesthesia, pain control and the treatment of focal neuropathies. We are also developing neurostimulation-based devices that promote nerve fiber regeneration in acute peripheral nerve and spinal cord injuries. For more information, visit http://www.neurometrix.com.

 

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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 NeuroMetrix’s or its management’s expectations, hopes, beliefs, intentions or strategies regarding the future. The words “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “plan,” “hope” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. The forward-looking statements contained in this press release are based on NeuroMetrix’s current expectations and beliefs concerning future developments and their potential effects on it. There can be no assurance that future developments affecting NeuroMetrix will be those that NeuroMetrix has anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond NeuroMetrix’s control) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to, risks associated with: reimbursement by third party payers to the Company’s customers for procedures performed using the NC-stat System and the ADVANCE System, including the AMA CPT Editorial Panel process and the risk that the reimbursement amount under any new CPT code for nerve conduction studies performed with pre-configured electrode arrays may be lower than the reimbursement amount under existing CPT codes for nerve conduction studies; obtaining necessary regulatory approvals or clearances, including the pending 510(k) filing with the United States Food and Drug Administration (“FDA”) relating to portions of the onCall Information System that are currently in use for the NC-stat System and FDA approval of the Andara OFS System; the ability of NeuroMetrix to develop new products based on the intellectual property acquired from Cyberkinetics; the ability of NeuroMetrix to obtain additional funding for product development or otherwise; NeuroMetrix ability to successfully develop product enhancements to the ADVANCE System; our success in marketing the ADVANCE System; protection of NeuroMetrix’s intellectual property and other proprietary rights; reliance on third party manufacturers and suppliers; NeuroMetrix’s financial condition; plus factors described under the heading “Item 1A. Risk Factors” in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2007 or described in the Company’s other public filings. Should one or more of these risks or uncertainties materialize, or should any of NeuroMetrix’s assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements. NeuroMetrix undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.

 

CONTACT:

NeuroMetrix, Inc.

Joe Calo, 781-314-2775

Acting CFO

neurometrix.ir@neurometrix.com

 

SOURCE:

NeuroMetrix, Inc.

 

4



 

NeuroMetrix, Inc.

Condensed Statement of Operations

(Unaudited)

 

 

 

Three Months Ended

 

Twelve Months Ended

 

 

 

December 31, 2008

 

December 31, 2007

 

December 31, 2008

 

December 31, 2007

 

 

 

 

 

 

 

 

 

 

 

Revenues:

 

 

 

 

 

 

 

 

 

Medical equipment

 

$

1,030,065

 

$

826,327

 

$

2,709,104

 

$

4,254,011

 

Consumables

 

6,150,006

 

8,997,821

 

28,411,696

 

39,413,265

 

Total revenues

 

7,180,071

 

9,824,148

 

31,120,800

 

43,667,276

 

 

 

 

 

 

 

 

 

 

 

Costs and expenses:

 

 

 

 

 

 

 

 

 

Cost of revenues

 

2,310,569

 

2,661,176

 

9,011,941

 

11,337,822

 

Research and development

 

1,139,800

 

1,119,522

 

5,256,721

 

4,891,937

 

Sales and marketing

 

2,480,423

 

4,887,373

 

14,646,958

 

22,836,867

 

General and administrative

 

1,998,756

 

3,718,059

 

12,016,158

 

14,834,073

 

Charge for impaired goodwill

 

 

 

5,833,464

 

 

Charge for settlement

 

3,705,866

 

 

3,705,866

 

 

Charge for intangible assets impairment

 

1,767,500

 

 

1,767,500

 

 

Gain from deconsolidation of joint venture

 

(1,968,750

)

 

(2,100,000

)

 

Amortization of intangible assets

 

70,000

 

 

332,500

 

 

Total operating expenses

 

11,504,164

 

12,386,130

 

50,471,108

 

53,900,699

 

Loss from continuing operations

 

(4,324,093

)

(2,561,982

)

(19,350,308

)

(10,233,423

)

Loss on available-for-sale investment

 

(273,546

)

 

(2,500,000

)

 

Interest income

 

103,091

 

374,830

 

720,932

 

1,750,963

 

Loss from continuing operations

 

(4,494,548

)

(2,187,152

)

(21,129,376

)

(8,482,460

)

Gain (loss) from discontinued operations

 

352,101

 

47,876

 

(6,600,673

)

103,986

 

Net loss

 

$

(4,142,447

)

$

(2,139,276

)

$

(27,730,049

)

$

(8,378,474

)

Basic and diluted net loss per common share from continuing operations

 

$

(0.33

)

$

(0.17

)

$

(1.54

)

$

(0.67

)

Basic and diluted net loss per common share from discontinued operations

 

$

0.03

 

$

0.00

 

$

(0.48

)

$

0.01

 

Basic and diluted net loss per common share

 

$

(0.30

)

$

(0.17

)

$

(2.02

)

$

(0.66

)

Basic and diluted weighted average shares used to compute net loss per common share

 

13,774,789

 

12,693,209

 

13,733,250

 

12,628,310

 

 

5



 

NeuroMetrix, Inc.

Condensed Balance Sheets

(Unaudited)

 

 

 

December 31, 2008

 

December 31, 2007

 

 

 

 

 

 

 

Assets

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

12,302,284

 

$

7,097,239

 

Short-term held-to-maturity investments

 

7,495,000

 

22,621,741

 

Restricted cash

 

 

45,000

 

Accounts receivable, net

 

3,660,848

 

5,731,697

 

Inventories

 

5,606,807

 

5,354,338

 

Prepaid expenses and other current assets

 

313,795

 

710,159

 

Current portion of deferred costs

 

263,755

 

464,061

 

Total current assets

 

29,642,489

 

42,024,235

 

 

 

 

 

 

 

Restricted cash

 

408,000

 

1,458,598

 

Fixed assets, net

 

1,073,176

 

2,973,718

 

Long-term available-for-sale investment

 

 

1,058,255

 

Goodwill

 

 

5,833,464

 

Intangible assets, net

 

 

2,800,000

 

Deferred costs

 

116,972

 

226,304

 

Other long-term assets

 

137,705

 

 

Total assets

 

$

31,378,342

 

$

56,374,574

 

 

 

 

 

 

 

Liabilities and Stockholders’ Equity

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

 

 

 

Accounts payable

 

$

201,275

 

$

2,627,889

 

Accrued expenses

 

6,722,129

 

4,436,109

 

Current portion of deferred revenue

 

1,057,215

 

1,643,026

 

Current portion of capital lease obligation

 

29,748

 

12,900

 

Total current liabilities

 

8,010,367

 

8,719,924

 

 

 

 

 

 

 

Deferred revenue

 

483,365

 

891,958

 

Capital lease obligation - net of current portion

 

52,059

 

18,275

 

Other long-term liabilities

 

 

14,546

 

Total liabilities

 

8,545,791

 

9,644,703

 

 

 

 

 

 

 

Stockholders’ equity

 

 

 

 

 

Common stock

 

1,386

 

1,369

 

Additional paid-in capital

 

112,626,802

 

110,235,835

 

Accumulated deficit

 

(89,795,637

)

(62,065,588

)

Accumulated other comprehensive loss

 

 

(1,441,745

)

Total stockholders’ equity

 

22,832,551

 

46,729,871

 

Total liabilities and stockholders' equity

 

$

31,378,342

 

$

56,374,574

 

 

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