-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, Vg7jaMDpdyOEjpLJRjDocUUTate7MCQrvjNMyykN3kUVI3XOxDPIu9T5lRHaM/sZ amres3Bx49zffA8QxdXb6Q== 0001157523-10-004438.txt : 20100729 0001157523-10-004438.hdr.sgml : 20100729 20100729074630 ACCESSION NUMBER: 0001157523-10-004438 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20100729 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20100729 DATE AS OF CHANGE: 20100729 FILER: COMPANY DATA: COMPANY CONFORMED NAME: NMT MEDICAL INC CENTRAL INDEX KEY: 0001017259 STANDARD INDUSTRIAL CLASSIFICATION: SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841] IRS NUMBER: 954090463 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-21001 FILM NUMBER: 10975958 BUSINESS ADDRESS: STREET 1: 27 WORMWOOD STREET CITY: BOSTON STATE: MA ZIP: 02210 BUSINESS PHONE: 6177370930 MAIL ADDRESS: STREET 1: 27 WORMWOOD STREET CITY: BOSTON STATE: MA ZIP: 02210 FORMER COMPANY: FORMER CONFORMED NAME: NITINOL MEDICAL TECHNOLOGIES INC DATE OF NAME CHANGE: 19960619 8-K 1 a6376886.htm NMT MEDICAL, INC. 8-K


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): July 29, 2010


NMT Medical, Inc.
(Exact Name of Registrant as Specified in Charter)


Delaware

000-21001

95-4090463

(State or Other Jurisdiction

of Incorporation)

(Commission File Number)

 

(IRS Employer

Identification No.)

27 Wormwood Street
Boston, Massachusetts

 

02210-1625

(Address of Principal Executive Offices)

(Zip Code)

Registrant’s telephone number, including area code: (617) 737-0930

Not Applicable
(Former Name or Former Address, if Changed Since Last Report)


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):

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

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

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

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 July 29, 2010, NMT Medical, Inc. announced its financial results for the quarter ended June 30, 2010. The full text of the press release issued in connection with the announcement is attached as Exhibit 99.1 to this Current Report on Form 8-K.

The information in this Current Report on Form 8-K and the Exhibit attached hereto shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

Item 9.01. Financial Statements and Exhibits.
  (d) Exhibits.

See Exhibit Index attached hereto.


SIGNATURE

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

 

NMT MEDICAL, INC.

 
Date: July 29, 2010 By:

/s/ Richard E. Davis

Richard E. Davis

Chief Operating Officer


Exhibit Index

Exhibit No.

 

Description

99.1

Press Release dated July 29, 2010.

EX-99.1 2 a6376886ex99_1.htm EXHIBIT 99.1

Exhibit 99.1

NMT Medical Announces Second-Quarter 2010 Financial Results

Company in Discussions with FDA to Evaluate Options for PFO Closure Technology

BOSTON--(BUSINESS WIRE)--July 29, 2010--NMT Medical, Inc. (NASDAQ: NMTI), an advanced medical technology company that designs, develops, manufactures and markets proprietary implant technologies that allow interventional cardiologists to treat structural heart disease through minimally invasive, catheter-based procedures, today announced financial results for the quarter ended June 30, 2010.

Second-Quarter Results

Second-quarter 2010 total revenues were approximately $2.6 million compared with approximately $3.2 million for the quarter ended June 30, 2009.

Cardiac septal repair implant sales in North America for the second quarter of 2010 were approximately $1.9 million compared with approximately $2.4 million in the second quarter of 2009. Implant sales outside of North America were approximately $700,000 in the second quarter of 2010 compared with $800,000 in the corresponding period of 2009.

For the second quarter of 2010, NMT reported net income of approximately $2.6 million, or $0.16 per diluted share, compared with a net loss of approximately $3.8 million, or $0.29 per share, for the corresponding period in 2009. Net income for the second quarter of 2010 includes a non-cash, pre-tax gain of $6.4 million related to the change in fair value of the warrants issued in February 2010 as part of the Company’s $5.8 million financing. For the second-quarter of 2010, NMT reported a loss from operations of approximately $4.0 million compared with a loss of approximately $3.9 million in the same period of 2009.

Management Comments

“During the second quarter, we believe the medical community was eagerly anticipating the results of CLOSURE I, our pivotal patent foramen ovale (PFO)/stroke and transient ischemic attack (TIA) trial, which may have slowed the referral pattern and the number of procedures performed during the second quarter in the U.S.,” said President and Chief Executive Officer Frank Martin. “In addition, our revenues outside of North America reflect a shortfall in our larger Western European markets.”

“We commenced data analysis for CLOSURE I early in the quarter and announced preliminary results in mid-June, which indicated that the trial did not meet its primary endpoint,” Martin said. “However, the preliminary results of CLOSURE I did confirm several positive attributes of our technology. While the trial did not demonstrate that treatment by device closure with the STARFlex® implant is superior, the results indicate that closure with STARFlex® provided a small, but not statistically significant, benefit over current best medical therapy. The primary endpoint included the incidence of a recurrent stroke/TIA confirmed by MRI imaging. In addition to a very low rate of thrombus formation, for the first time in any prospective, randomized and independent core lab adjudicated PFO related trial, the results indicate that the safety profile of the STARFlex® device had a low rate of complications, similar to that of current best medical therapy. Closure rates in the trial were 86.5%, which is consistent with NMT’s previously reported results for the STARFlex® implant. We are currently in discussions with the U.S. Food and Drug Administration to evaluate our possible next steps relating to the stroke/TIA indication. We plan to provide an update, once an appropriate course of action has been determined. We currently anticipate that full trial data results will be discussed at the American Heart Association meeting in November 2010.”


Chief Operating Officer, Richard E. Davis, said, “As of June 30, 2010, cash, cash equivalents and marketable securities were approximately $6.5 million. Going forward, we will continue to tightly manage expenses, preserve cash, evaluate financing alternatives and adjust our operating plan accordingly in order to support our ongoing clinical trials and development programs. We currently expect third-quarter 2010 revenues to be approximately $2.5 million.”

Conference Call Reminder

Management will conduct a conference call at 9:30 a.m. ET today to review the Company’s financial results and provide a business update. Individuals who are interested in listening to the live webcast should log on to the “Investors” section of NMT Medical’s website at www.nmtmedical.com. The conference call also may be accessed by dialing (877) 407-5790 or (201) 689-8328. For interested individuals unable to join the live conference call, a replay will be archived for one year via webcast on the Company’s website.

About NMT Medical, Inc.

NMT Medical is an advanced medical technology company that designs, develops, manufactures and markets proprietary implant technologies that allow interventional cardiologists to treat structural heart disease through minimally invasive, catheter-based procedures. NMT is currently investigating the potential connection between a common heart defect that allows a right-to-left shunt or flow of blood through a defect like a patent foramen ovale (PFO) and brain attacks such as embolic stroke, transient ischemic attacks (TIAs) and migraine headaches. A common right-to-left shunt can allow venous blood, unfiltered and unmanaged by the lungs, to enter the arterial circulation of the brain, possibly triggering a cerebral event or brain attack. More than 33,000 PFOs have been treated globally with NMT's minimally invasive, catheter-based implant technology.

For more information about NMT Medical, please visit www.nmtmedical.com.

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements – including statements regarding the timing, cost, clinical status, and outcome of the Company’s CLOSURE I trial, its ongoing clinical trials and development programs, the Company’s revenue expectations for the third quarter of 2010, the Company’s expected savings from cost reductions, the success of its new distribution partnerships, expansion of the Company’s cardiovascular business and market opportunities, including stroke, TIA and any other new applications for the Company’s technology or products, regulatory approvals for the Company’s products in the United States and abroad and the Company’s investment in product development – involve known and unknown risks, uncertainties or other factors that may cause actual results, performance or achievements of the Company to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Factors that may cause such a difference include, but are not limited to, the Company’s ability to develop and commercialize new products, a potential delay in the regulatory process with the U.S. Food and Drug Administration and foreign regulatory agencies, as well as risk factors discussed under the heading “Risk Factors” included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2009, Form 10-Q for the quarter ended March 31, 2010 and subsequent filings with the U.S. Securities and Exchange Commission.


NMT Medical, Inc. and Subsidiaries
Consolidated Statements of Operations
(Unaudited)
             
For The Three Months Ended For The Six Months Ended
June 30 June 30
2010   2009 2010   2009
 
Product sales $ 2,574,844 $ 3,181,843 $ 5,569,152 $ 6,659,614
 
 
Costs and expenses:
Cost of product sales 1,389,938 1,416,760 2,616,887 2,826,006
Research and development 1,840,521 2,432,422 3,664,527 4,626,658
General and administrative 2,047,307 1,701,954 4,002,951 4,104,481
Selling and marketing   1,298,914     1,516,459     2,488,595     2,816,918  
Total cost and expenses   6,576,680     7,067,595     12,772,960     14,374,063  
 
       
Loss from operations   (4,001,836 )   (3,885,752 )   (7,203,808 )   (7,714,449 )
 
Other income (expense):
Gain on change in fair value of warrants 6,410,503 - 1,755,906 -
Currency transaction (loss) gain (24,228 ) 23,623 (74,797 ) 2,733
Interest income   2,438     24,741     4,117     81,393  
Total other income, net   6,388,713     48,364     1,685,226     84,126  
 
Income (loss) before income taxes 2,386,877 (3,837,388 ) (5,518,582 ) (7,630,323 )
 
Income tax (benefit) expense   (181,058 )   10,557     (170,569 )   20,395  
 
Net income (loss) $ 2,567,935   $ (3,847,945 ) $ (5,348,013 ) $ (7,650,718 )
 
Net income (loss) per common share:
Basic $ 0.16   $ (0.29 ) $ (0.35 ) $ (0.58 )
 
Diluted $ 0.16   $ (0.29 ) $ (0.35 ) $ (0.58 )
 
Weighted average common shares outstanding:
Basic   16,019,272     13,204,106     15,346,602     13,152,940  
 
Diluted   16,276,453     13,204,106     15,346,602     13,152,940  
 

NMT Medical, Inc. and Subsidiaries
Consolidated Balance Sheets
(Unaudited)
        At June 30,   At December 31,
2010 2009
 
Assets
Current assets:
Cash and cash equivalents $ 3,147,835 $ 8,926,329
Marketable securities 3,386,339 -
Accounts receivable, net 1,313,834 1,683,829
Inventories 1,947,999 1,658,646
Prepaid expenses and other current assets   1,054,650     1,029,348  
Total current assets 10,850,657 13,298,152
 
Property and equipment, net   584,056     694,520  
 
 
Total Assets $ 11,434,713   $ 13,992,672  
 
Liabilities and Stockholders' Equity
Current liabilities:
Accounts payable $ 3,877,300 $ 5,017,863
Accrued expenses   5,022,599     5,840,908  
Total current liabilities 8,899,899 10,858,771
 
Warrant liability 585,568 -
Other long-term liabilities   581,616     554,143  
Total long-term liabilities 1,167,184 554,143
 
Stockholders' equity:
Preferred stock, $.001 par value
Authorized--3,000,000 shares
Issued and outstanding--none - -
Common stock, $.001 par value
Authorized--30,000,000 shares
Issued and outstanding-- 16,060,069 and 13,268,294
shares in 2010 and 2009, respectively 16,060 13,268
Additional paid-in capital 57,310,669 53,175,464
Less treasury stock - 40,000 shares at cost (119,600 ) (119,600 )
Accumulated other comprehensive loss (2,112 ) -
Accumulated deficit   (55,837,387 )   (50,489,374 )
Total stockholders' equity   1,367,630     2,579,758  
 
Total Liabilities and Stockholders' Equity $ 11,434,713   $ 13,992,672  

CONTACT:
NMT Medical, Inc.
Richard E. Davis, 617-737-0930
Chief Operating Officer
red@nmtmedical.com

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