BOSTON, MA--(Marketwire - November 09, 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
September 30, 2010.
Third-Quarter Results
Third-quarter 2010 total revenues were approximately $2.1 million compared
with approximately $3.0 million for the quarter ended September 30, 2009.
Cardiac septal repair implant sales in North America for the third quarter
of 2010 were approximately $1.5 million compared with approximately $2.3
million in the third quarter of 2009. Implant sales outside of North
America were approximately $550,000 in the third quarter of 2010 compared
with approximately $700,000 in the corresponding period of 2009.
For the third quarter of 2010, NMT reported a net loss of approximately
$3.4 million, or $0.21 per share, compared with a net loss of approximately
$2.9 million, or $0.22 per share, for the corresponding period in 2009.
The net loss for the third quarter of 2010 includes a non-cash, pre-tax
gain of $175,000 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
third quarter of 2010, NMT reported a loss from operations of approximately
$3.5 million compared with a loss of approximately $2.9 million in the same
period of 2009.
Management Comments
"Sales of NMT's cardiac septal repair implant technologies continued to
underperform our expectations, especially in Europe," said Chairman,
President & Chief Executive Officer Richard E. Davis. "In response to our
performance, we have refocused our sales strategy in certain countries in
Western Europe where we believe there is the most opportunity for growth,
such as Germany and the United Kingdom. We anticipate that this will
improve implant unit sales, while not increasing our expense structure."
"On November 4, the CLOSURE I methodology paper, which provided a detailed
explanation of the trial design, was made available by electronic copy on
the STROKE website. The full set of data from the trial is undergoing
final analysis and the findings will be presented at the American Heart
Association meeting on November 15 by the CLOSURE I Principal Investigator,
Anthony Furlan, MD. It is anticipated that results from the trial will be
published in a peer-reviewed journal in the next several weeks. The
preliminary results of CLOSURE I, despite not meeting the primary endpoint,
did confirm several positive attributes of our technology. The data
demonstrated that NMT's STARFlex® technology provided a small benefit
over current best medical therapy."
"As of September 30, 2010, cash, cash equivalents and marketable securities
were approximately $3.4 million. We are continuing to consider all
potential financing alternatives and are evaluating our strategic options
accordingly in order to provide the liquidity necessary to sustain our
operations, including ongoing clinical trials and development programs,
beyond the fourth quarter of 2010. We continue to tightly manage all
expenses and currently expect fourth-quarter 2010 revenues to be
approximately $2.3 million," Mr. Davis concluded.
Conference Call Reminder
Management will conduct a conference call at 9:30 a.m. ET today, November
9, 2010, 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 34,000 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 fourth quarter of 2010, the Company's plans and
ability to raise additional financing, the success of its new direct sales
strategy, 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 June 30, 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 Nine Months Ended
September 30 September 30
-------------------------- --------------------------
2010 2009 2010 2009
------------ ------------ ------------ ------------
Product sales $ 2,059,314 $ 3,002,832 $ 7,628,466 $ 9,662,446
Costs and expenses:
Cost of product
sales 1,122,725 1,195,081 3,739,612 4,021,087
Research and
development 1,653,834 2,009,843 5,318,361 6,636,501
General and
administrative 1,795,469 1,390,647 5,798,420 5,495,128
Selling and
marketing 990,252 1,275,212 3,478,847 4,092,130
------------ ------------ ------------ ------------
Total cost and
expenses 5,562,280 5,870,783 18,335,240 20,244,846
------------ ------------ ------------ ------------
------------ ------------ ------------ ------------
Loss from
operations (3,502,966) (2,867,951) (10,706,774) (10,582,400)
------------ ------------ ------------ ------------
Other income:
Gain on change in
fair value of
warrants 175,333 - 1,931,239 -
Currency
transaction gain
(loss) 2,433 11,231 (72,364) 13,964
Interest
(expense) income (4,281) 6,926 (164) 88,319
------------ ------------ ------------ ------------
Total other
income 173,485 18,157 1,858,711 102,283
------------ ------------ ------------ ------------
Loss before
income taxes (3,329,481) (2,849,794) (8,848,063) (10,480,117)
Income tax
expense
(benefit) 41,710 9,571 (128,859) 29,966
------------ ------------ ------------ ------------
Net loss $ (3,371,191) $ (2,859,365) $ (8,719,204) $(10,510,083)
============ ============ ============ ============
Basic & diluted
loss per common
share: $ (0.21) $ (0.22) $ (0.56) $ (0.80)
============ ============ ============ ============
Basic & diluted
weighted average
common shares
outstanding: 16,020,069 13,221,195 15,597,148 13,175,941
============ ============ ============ ============
NMT Medical, Inc. and Subsidiaries
Consolidated Balance Sheets
(Unaudited)
At September 30, At December 31,
2010 2009
--------------- ---------------
Assets
Current assets:
Cash and cash equivalents $ 2,472,679 $ 8,926,329
Marketable securities 928,172 -
Accounts receivable, net 1,129,491 1,683,829
Inventories 1,633,516 1,658,646
Prepaid expenses and other current
assets 1,081,891 1,029,348
--------------- ---------------
Total current assets 7,245,749 13,298,152
Property and equipment, net 530,721 694,520
--------------- ---------------
Total Assets $ 7,776,470 $ 13,992,672
=============== ===============
Liabilities and Stockholders' (Deficit)
Equity
Current liabilities:
Accounts payable $ 4,076,842 $ 5,017,863
Accrued expenses 4,666,746 5,840,908
--------------- ---------------
Total current liabilities 8,743,588 10,858,771
Warrant liability 410,235 -
Other long-term liabilities 594,758 554,143
--------------- ---------------
Total liabilities 9,748,581 11,412,914
--------------- ---------------
Stockholders' (deficit) 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 57,340,133 53,175,464
Less treasury stock - 40,000 shares at
cost (119,600) (119,600)
Accumulated other comprehensive loss (126) -
Accumulated deficit (59,208,578) (50,489,374)
--------------- ---------------
Total stockholders' (deficit)
equity (1,972,111) 2,579,758
--------------- ---------------
Total Liabilities and Stockholders'
(Deficit) Equity $ 7,776,470 $ 13,992,672
=============== ===============
