NMT Medical Announces Second-Quarter 2008 Financial Results
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BOSTON--(Business Wire)--
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, 2008.
Second-Quarter Results
Second-quarter 2008 total revenues were approximately $4.5 million
compared with approximately $6.5 million for the quarter ended June
30, 2007. Revenues for the second quarter of 2007 included
approximately $1.5 million of net royalty income. Under the terms of
the sale of the vena cava filter product line to C.R. Bard, the net
royalty payments relating to the Bard transaction are now reported as
a general and administrative expense, which was approximately $300,000
for the second quarter of 2008.
Total worldwide cardiac septal repair implant sales for the second
quarter of 2008 were approximately $4.5 million compared with
approximately $4.9 million for the second quarter of 2007. Implant
sales in North America for the second quarter of 2008 were
approximately $2.9 million compared with approximately $3.7 million in
the second quarter of 2007. European implant sales in the second
quarter of 2008 were approximately $1.6 million compared with $1.2
million in the corresponding period of 2007.
For the second quarter of 2008, NMT reported a net loss of
approximately $5.6 million, or $0.43 per share. This compares with a
net loss of approximately $2.6 million, or $0.20 per share, for the
corresponding period in 2007.
Comments on the Second Quarter
"Second quarter total revenues were below our expectations," said
President and Chief Executive Officer John E. Ahern. "In Europe we
remain encouraged by the continued acceptance of our new bioabsorbable
septal repair implant technology, BioSTAR(R). Despite greater than 30%
growth in European sales, we did not achieve our targeted level of
revenue there due to several factors including increased competition
and greater clinical trial activity for patent foramen ovale (PFO)
devices and percutaneous valve repair. Both of these activities
compete for limited cath-lab time and reduce elective PFO procedure
revenues. We believe this will continue as a short-term challenge to
expanding our revenue growth in Europe. In the United States, sales
results were in line with our expectations."
"While we had anticipated a faster increase of BioSTAR(R) sales in
Europe, we are confident that we are gaining market share there,"
Ahern continued. "We are currently competing for market share against
over ten septal heart repair devices that are either commercially
available or are in a clinical trial. None of those competing devices
has the technology profile of BioSTAR(R), which is designed to repair,
replace or regenerate cardiac tissue; demonstrate no adverse behavior;
and then bioabsorb as part of the healing process. As a result of
positive feedback from physicians and patients since its launch in
late 2007, more than 1,000 procedures have been successfully performed
with BioSTAR(R)."
"We remain focused on our primary long-term objective: to
establish a sustainable leadership position in the potentially large
emerging healthcare opportunity for cardiac septal repair," Ahern
said. "We intend to attain that objective with innovative technologies
like BioSTAR(R) and by providing clinically relevant data. There are
currently more than 700 peer-reviewed publications on the treatment of
PFOs in certain patient subsets. However, no prospective, randomized,
controlled trials have been completed that evaluate the risk-benefit
of preventing recurrent stroke and transient ischemic attack (TIA) in
patients with a PFO. Our strategy has been to be the first company in
the space to provide the required clinical evidence through our
pivotal PFO/stroke clinical trial, CLOSURE I. We continued to make
steady enrollment progress in the CLOSURE I trial during the second
quarter and, with approximately 25 patients left to enroll, we
currently believe it will be completed soon. In addition, we are
continuing to work with our statistical experts, investigators and the
U.S. Food and Drug Administration to determine what modifications, if
any, can be made to the timing of our data analysis. Currently, the
trial requires a two year follow up period. An alternative plan is
under evaluation that would possibly reduce the time required for
analysis to less than two years."
Executive Vice President and Chief Financial Officer Richard E.
Davis said, "During the quarter, we continued to effectively manage
our expenses. As a result, we continue to believe that we have
sufficient cash on hand to complete our ongoing clinical trials and
submit a pre-market approval (PMA) application in the U.S. for the
stroke indication. At June 30, 2008, cash and marketable securities
were approximately $25.3 million."
Year-To-Date Results
Total revenues for the six months ended June 30, 2008 were
approximately $9.3 million compared with approximately $13.3 million
for the same period in 2007. Revenues for the six months ended June
30, 2008 included approximately $18,200 of net royalty income,
compared with approximately $3.3 million of net royalty income for the
corresponding period in 2007.
Total worldwide cardiac septal repair implant sales for the first
six months of 2008 were approximately $9.3 million compared with
approximately $10.0 million for the same period in 2007. Implant sales
in North America for the first six months of 2008 were approximately
$5.7 million compared with approximately $7.7 million for the first
six months of 2007. European implant sales were approximately $3.6
million for the six-month period ended June 30, 2008, compared with
approximately $2.3 million for the corresponding period in 2007.
The net loss for the six-month period ended June 30, 2008 was
approximately $9.5 million, or $0.73 per share, compared with a net
loss of approximately $3.0 million, or $0.23 per share, for the
corresponding period in 2007.
Business Outlook
"Looking at the second half of 2008, we will remain focused on our
two major near-term goals: establishing an even stronger presence for
BioSTAR(R) in Europe and Canada and completing enrollment in CLOSURE
I. NMT intends to be the first company to submit a PMA for the
PFO/stroke/TIA indication in the U.S.," said Ahern.
"Positive results from CLOSURE I would have a significant impact
on the current clinical practice worldwide," said Ahern. "The
potential worldwide market for percutaneous PFO closure to prevent
recurrent stroke and TIA is estimated to be up to $4 billion
annually."
Davis concluded, "We currently expect total revenue for the third
quarter of 2008 to be approximately $4.8 to $5.2 million. For the full
year, we are revising our total revenue guidance to approximately $19
to $20 million. The downward revision in our full year revenue
guidance is related to the slower-than-expected ramp up of BioSTAR(R)
sales in Europe. We will continue to invest in our ongoing clinical
trials and development programs, as well as our sales and marketing
strategies. As a result, we currently expect cash, cash equivalents
and marketable securities at December 31, 2008 to be approximately $16
million."
Conference Call Reminder
Management will conduct a conference call at 10:00 a.m. ET today
to review the Company's financial results, provide clinical study
updates and discuss its outlook for the third quarter of 2008.
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 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 28,000 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. The prevalence of migraines in the United States is
about 10%. Of the 28 million migraine sufferers in America, those who
experience aura and have a PFO may represent a three million patient
subset.
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, rate and amount of patient enrollment, clinical status,
and outcome of the Company's CLOSURE I trial, as well as its
BioSTAR(R) and BioTREK(TM) programs, the Company's financial and sales
expectations (including the anticipated geographic break out of such
sales), profitability expectations and cash position, expansion of the
Company's cardiovascular business and market opportunities, including
stroke, TIAs and migraines 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, 2007, Quarterly
Report on Form 10-Q for the period ended March 31, 2008, and
subsequent filings with the U.S. Securities and Exchange Commission.
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NMT Medical, Inc. and Subsidiaries
Consolidated Statements of Operations
For The Three Months For The Six Months Ended
Ended
June 30, June 30,
------------------------- --------------------------
2008 2007 2008 2007
------------------------- --------------------------
Revenues:
Product sales $ 4,456,920 $ 4,922,265 $ 9,264,905 $10,037,768
Net royalty
income 5,900 1,549,570 18,170 3,267,895
------------ ------------ ------------- ------------
Total revenue 4,462,820 6,471,835 9,283,075 13,305,663
------------ ------------ ------------- ------------
Operating expenses:
Cost of product
sales 1,353,867 1,358,739 2,816,103 2,588,692
Research and
development 3,769,167 4,091,456 6,744,296 6,605,954
General and
administrative 2,427,616 1,886,356 4,883,241 3,899,516
Selling and
marketing 2,724,405 2,304,740 4,888,530 4,351,430
------------ ------------ ------------- ------------
Total
operating
expenses 10,275,055 9,641,291 19,332,170 17,445,592
------------ ------------ ------------- ------------
Loss from
operations (5,812,235) (3,169,456) (10,049,095) (4,139,929)
------------ ------------ ------------- ------------
Other income (expense):
Currency
transaction
gain (loss) 8,760 (18,689) 69,830 30,716
Interest income 203,206 476,611 502,567 985,691
------------ ------------ ------------- ------------
Total other
income 211,966 457,922 572,397 1,016,407
------------ ------------ ------------- ------------
Loss before
income taxes (5,600,269) (2,711,534) (9,476,698) (3,123,522)
Income tax
expense
(benefit) 24,326 (75,500) 41,670 (151,000)
------------ ------------ ------------- ------------
Net loss $(5,624,595) $(2,636,034) $ (9,518,368) $(2,972,522)
============ ============ ============= ============
Basic & diluted
loss per common
share: $ (0.43) $ (0.20) $ (0.73) $ (0.23)
============ ============ ============= ============
Basic & diluted
weighted average
common shares
outstanding: 13,007,547 12,916,357 12,990,844 12,894,762
============ ============ ============= ============
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NMT Medical, Inc. and Subsidiaries
Consolidated Balance Sheets
At June 30, At December 31,
2008 2007
------------- ---------------
Assets
Current assets:
Cash and cash equivalents $ 14,019,900 $ 6,984,383
Marketable securities 11,235,642 23,989,995
Accounts receivable, net 2,811,928 3,046,308
Inventories 2,495,787 2,071,534
Prepaid expenses and other current
assets 1,228,089 3,407,084
------------- ---------------
Total current assets 31,791,346 39,499,304
Property and equipment, net 1,039,906 1,103,545
------------- ---------------
$ 32,831,252 $ 40,602,849
============= ===============
Liabilities and Stockholders' Equity
Current liabilities:
Accounts payable $ 3,607,375 $ 2,456,316
Accrued expenses 6,391,968 6,221,427
------------- ---------------
Total current liabilities 9,999,343 8,677,743
Long-term liabilities 338,512 352,185
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--13,047,767 and
13,012,142 shares in 2008 and 2007,
respectively 13,048 13,012
Additional paid-in capital 52,101,274 51,645,489
Less treasury stock - 40,000 shares at
cost (119,600) (119,600)
Accumulated other comprehensive (loss)
income (13,104) 3,873
Accumulated deficit (29,488,221) (19,969,853)
------------- ---------------
Total stockholders' equity 22,493,397 31,572,921
------------- ---------------
$ 32,831,252 $ 40,602,849
============= ===============
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NMT Medical, Inc.
Richard E. Davis, 617-737-0930
Executive Vice President & Chief Financial Officer
red@nmtmedical.com
Copyright Business Wire 2008
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