May 4 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 March 31, 2010.
“Data for CLOSURE I were recently locked and the analysis commenced on schedule”
First-Quarter Results
First-quarter 2010 total revenues were approximately $3.0 million compared with approximately $3.5 million for the quarter ended March 31, 2009.
Cardiac septal repair implant sales in North America for the first quarter of 2010 were approximately $2.0 million compared with approximately $2.3 million in the first quarter of 2009. Implant sales outside of North America were approximately $1.0 million in the first quarter of 2010 compared with $1.2 million in the corresponding period of 2009.
For the first quarter of 2010, NMT reported a net loss of approximately $7.9 million, or $0.54 per share, compared with a net loss of approximately $3.8 million, or $0.29 per share, for the corresponding period in 2009. The net loss for the first quarter of 2010 included a non-cash pre-tax expense of $4.7 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. NMT reported a lower loss from operations of approximately $3.2 million, or $0.22 per share, in the first quarter of 2010 compared with $3.8 million, or $0.29 per share, in the same period of 2009.
Management Comments
"NMT's total revenues for the first quarter of 2010 were in line with our expectations," said President and Chief Executive Officer Frank Martin. "The ongoing general macroeconomic softness in North America and Europe continues to affect our implant sales. In addition, we believe the growing anticipation in the medical community for the results of CLOSURE I, our pivotal patent foramen ovale (PFO)/stroke and transient ischemic attack (TIA) trial in the United States may be slowing the referral pattern of patients for these procedures. Despite these short-term challenges, we are encouraged by the rate of acceptance of our technologies as we enter new international territories."
"Data for CLOSURE I were recently locked and the analysis commenced on schedule," Martin said. "By the fall of 2010, the trial will be complete and 100 percent of the randomized patient follow-up data will be available. Pending a positive outcome, we are continuing to target the third quarter of 2010 to submit an application for our STARFlex® device for the stroke and TIA indication to the U.S. Food and Drug Administration for Pre-Market Approval."
Chief Operating Officer, Richard E. Davis, said, "We have taken important steps to strengthen our balance sheet. During the first quarter, we completed a $5.8 million financing through a private placement of common stock and warrants. Since June 2009, we also have an established credit facility to draw from, that allows us to borrow up to a maximum of $4 million, subject to borrowing availability. In addition, we recently filed a $30 million universal shelf registration statement that, if and when the registration statement is declared effective, will enable us to opportunistically raise additional funds, subject to market conditions, as needed."
"Our current financial position gives us more confidence that we have the capital necessary to fully support our ongoing clinical trials and development programs and execute our business plan, including the commercial launch of STARFlex® for the stroke and TIA indication," said Davis. "However, we are continuing to tightly manage expenses, preserve cash, and adjust our operating plan, as appropriate, with the goal of minimizing our operating loss and cash used in operating activities. As of March 31, 2010, cash, cash equivalents and marketable securities were approximately $10.7 million."
"We will continue to identify new territories to establish distribution partnerships for our BioSTAR® technology as a cost-effective strategy to increase unit sales without incurring significant expenses. Pending results of the CLOSURE I trial, we continue to anticipate that full year 2010 revenues will increase modestly from 2009 levels," concluded Davis.
SOURCE NMT Medical, Inc.