-----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, TJlkdpbgS38B2BtvlqsyHSH5+Z8M1LvfOq3tP0y4eEw8yH2bQZBgW78+swABmgO4 E3uH1Ksf3J5yATp0AeGg4w== 0001157523-09-005519.txt : 20090804 0001157523-09-005519.hdr.sgml : 20090804 20090804074531 ACCESSION NUMBER: 0001157523-09-005519 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20090804 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20090804 DATE AS OF CHANGE: 20090804 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: 09981669 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 a6020959.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): August 4, 2009


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 August 4, 2009, NMT Medical, Inc. announced its financial results for the quarter ended June 30, 2009. 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: August 4, 2009 By:

/s/ Richard E. Davis

Richard E. Davis

Chief Operating Officer


Exhibit Index

Exhibit No.

Description

99.1

Press release dated August 4, 2009.

EX-99.1 2 a6020959-ex991.htm EXHIBIT 99.1

Exhibit 99.1

NMT Medical Announces Second-Quarter 2009 Financial Results

BOSTON--(BUSINESS WIRE)--August 4, 2009--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 and six months ended June 30, 2009.

Second-Quarter Results

Second-quarter 2009 total revenues were approximately $3.2 million compared with approximately $4.5 million for the quarter ended June 30, 2008.

Cardiac septal repair implant sales in North America for the second quarter of 2009 were approximately $2.4 million compared with approximately $2.9 million in the second quarter of 2008. Implant sales outside of North America in the second quarter of 2009 were approximately $800,000 compared with $1.6 million in the corresponding period of 2008.

For the second quarter of 2009, NMT narrowed its net loss to approximately $3.8 million, or $0.29 per share, compared with a net loss of approximately $5.6 million, or $0.43 per share, for the corresponding period in 2008.

Comments on the Second Quarter

“Total worldwide cardiac septal repair implant sales for the second quarter of 2009 were in line with our recently revised guidance,” said President and Chief Executive Officer Frank Martin. “Our near-term strategy has been to aggressively target emerging overseas markets through new distribution partnerships. However, it has taken longer than expected to complete the necessary product registrations in certain markets, which resulted in our international revenues being lower than anticipated for the second quarter.”

“We remain encouraged by the long-term opportunities available to us in these new territories,” said Martin. “We intend to continue with our geographic expansion plans and we are currently in the process of adding distributors for BioSTAR® in Eastern Europe, the Middle East and parts of Asia. As part of our strategy to reduce costs, we further streamlined our sales force in some territories outside of the U.S. by transitioning from direct sales to distribution partnerships. We believe that these new distribution partnerships will enhance our global presence and have the potential to significantly increase our commercial market share as we penetrate new territories.”


Chief Operating Officer Richard E. Davis said, “At June 30, 2009, cash, cash equivalents and marketable securities were approximately $12.4 million. In addition, NMT achieved an important milestone during the second quarter by securing a $4.0 million revolving credit facility with Silicon Valley Bank. This two-year, non-equity based credit facility provides us with additional financial flexibility. It also reinforces our confidence that we will have sufficient capital resources to complete our pivotal patent foramen ovale (PFO)/stroke trial – CLOSURE I.”

Year-To-Date Results

Total revenues for the six months ended June 30, 2009 were approximately $6.7 million compared with approximately $9.3 million for the same period in 2008.

Cardiac septal repair implant sales in North America for the first six months of 2009 were approximately $4.7 million compared with approximately $5.7 million for the first half of 2008. Implant sales outside of North America were approximately $2.0 million for the six-month period ended June 30, 2009 compared with approximately $3.6 million for the corresponding period in 2008.

The net loss for the six-month period ended June 30, 2009 narrowed to approximately $7.7 million, or $0.58 per share, compared with a net loss of approximately $9.5 million, or $0.73 per share, for the corresponding period in 2008.

Business Outlook

“Looking ahead, we remain committed to advancing NMT’s position as an established technology leader in cardiac septal repair,” Martin said. “While being prudent in our spending, we will continue to fund our R&D efforts and have several promising programs underway. CLOSURE I remains our top priority and, as previously announced, at this time, we expect the data from that trial to be reviewed in the fall of 2010.”

“For the second half of 2009, we will remain focused on our four major initiatives: 1) pursuing additional regulatory approvals for our technology, inclusive of CLOSURE I; 2) increasing BioSTAR® unit sales; 3) effectively managing our capital resources; and 4) expanding our international presence in the market of structural heart repair,” said Martin. “With the new distribution partnerships in place and registrations now complete in several new markets, we have the potential to drive near-term revenue with little additional costs. Our goal is to build sales momentum toward year-end through our expanded global footprint.”

Davis concluded, “For the full year 2009, we are expecting total revenues of approximately $14 to $15 million. We will continue to review all business operations for additional expense reduction opportunities. We currently expect cash, cash equivalents and marketable securities at December 31, 2009 to be within the range of $6 to $8 million.”


Conference Call Reminder

Management will conduct a conference call at 10:00 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) 407-8037 or (201) 689-8037. For interested individuals unable to join the live conference call, a replay will be available 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 30,000 PFOs have been treated globally with NMT's minimally invasive, catheter-based implant technology.

Stroke is a leading cause of death in the United States and the leading cause of disability in adults. Each year, 750,000 Americans suffer a new or recurrent stroke and an additional 500,000 Americans experience a TIA.

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 bioabsorbable technology programs, the Company’s expected savings from cost reductions, the Company’s expected cash position and burn rate for 2009, revenue expectations for 2009, the success of our 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, 2008, Quarterly Report on Form 10-Q for the quarter ended March 31, 2009, 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,
  2009       2008     2009       2008  
Revenues:
Product sales $ 3,181,843 $ 4,456,920 6,659,614 9,264,905
Net royalty income   -     5,900     -     18,170  
Total revenues   3,181,843     4,462,820     6,659,614     9,283,075  
 
 
Costs and expenses:
Cost of product sales 1,416,760 1,353,867 2,826,006 2,816,103
Research and development 2,432,422 3,769,167 4,626,658 6,744,296
General and administrative 1,701,954 2,427,616 4,104,481 4,883,241
Selling and marketing   1,516,459     2,724,405     2,816,918     4,888,530  
Total cost and expenses   7,067,595     10,275,055     14,374,063     19,332,170  
 
Loss from operations   (3,885,752 )   (5,812,235 )   (7,714,449 )   (10,049,095 )
 
Other income:
Currency transaction gain 23,623 8,760 2,733 69,830
Interest income   24,741     203,206     81,393     502,567  
Total other income   48,364     211,966     84,126     572,397  
 
Loss before income taxes (3,837,388 ) (5,600,269 ) (7,630,323 ) (9,476,698 )
 
Income tax expense   10,557     24,326     20,395     41,670  
 
Net loss $ (3,847,945 ) $ (5,624,595 ) $ (7,650,718 ) $ (9,518,368 )
 
 
Basic & diluted loss per common share: $ (0.29 ) $ (0.43 ) $ (0.58 ) $ (0.73 )
 
Basic & diluted weighted average common shares outstanding:   13,204,106     13,007,547     13,152,940     12,990,844  

NMT Medical, Inc. and Subsidiaries
Consolidated Balance Sheets
(Unaudited)
   
At June 30, At December 31,
2009 2008
 
Assets
Current assets:
Cash and cash equivalents $ 11,115,391 $ 4,899,179
Marketable securities 1,259,048 12,674,639
Accounts receivable, net 1,747,569 2,511,934
Inventories 1,733,465 2,018,173
Prepaid expenses and other current assets 1,234,709 1,212,947
Total current assets 17,090,182 23,316,872
 
Property and equipment, net 815,649 928,693
 
 
$ 17,905,831 $ 24,245,565
 
Liabilities and Stockholders' Equity
Current liabilities:
Accounts payable $ 4,620,177 $ 2,870,606
Accrued expenses 5,596,215 6,468,167
Total current liabilities 10,216,392 9,338,773
 
Long-term liabilities 535,328 507,426
 
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--13,244,106 and 13,122,391 shares in 2009 and 2008, respectively

13,244 13,122
Additional paid-in capital 52,951,695 52,659,855
Less treasury stock - 40,000 shares at cost (119,600) (119,600)
Accumulated other comprehensive income (loss) 5,094 (108,407)
Accumulated deficit (45,696,322) (38,045,604)
Total stockholders' equity 7,154,111 14,399,366
 
$ 17,905,831 $ 24,245,565

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

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