NMT Medical, Inc. (NMT Medical), a cardiovascular devices company, has reported total revenues of $17.9 million for the full year of 2008, compared with the total revenues of $26.8 million in the previous year-end. It has also reported a net loss of $18.1 million, or $1.39 loss per share, for the full year of 2008, compared with the net loss of $9.1 million, or $0.70 loss per share, in the previous year-end.
Fourth-Quarter Results
Fourth-quarter 2008 total revenues were about $4.4 million against about $7.0 million for the fourth quarter of 2007. Revenues for the fourth quarter of 2007 included about $1.8 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 about $75,000 for the fourth quarter of 2008.
Total worldwide cardiac septal repair implant sales for the fourth quarter of 2008 were about $4.4 million against about $5.3 million for the fourth quarter of 2007. Implant sales in North America for the fourth quarter of 2008 were about $3.0 million against about $3.1 million in the fourth quarter of 2007. European implant sales in the fourth quarter of 2008 were about $1.4 million against $2.2 million in the corresponding period of 2007.
For the fourth quarter of 2008, NMT reported a net loss of about $4.2 million, or $0.32 per share, against net loss of about $2.9 million, or $0.23 per share, for the corresponding period in 2007.
Comments on the Fourth Quarter
“NMT reported revenues for the fourth quarter and full-year 2008 in line with the levels we previously announced in January,” said NMT Medical’s interim president and chief executive officer Frank Martin. “With sales of our BioSTAR(R) implant, the only bioabsorbable cardiac septal repair technology available for use in humans, we continued to gain market share in Europe and Canada. In addition, during the quarter, we continued to work on finalizing a decision regarding the data analysis timing for CLOSURE I – our landmark patent foramen ovale (PFO)/stroke and transient ischemic attack (TIA) clinical trial in the U.S. We currently anticipate a decision within the next few weeks.”
“As announced in January, we took action to lower our expenses and operate with a leaner, more efficient cost structure given the current economic environment,” said Martin. “We implemented headcount reductions throughout the organization, reprioritized internal programs and restructured various departments. These actions are expected to result in annualized cost savings of greater than $1.0 million. In addition, we are confident that our current cash position will allow us to complete CLOSURE I and bring the STARFlex(R) implant to the U.S. market, contingent upon United States Food and Drug Administration (FDA) approval.”
Chief operating officer Richard E. Davis said, “We ended 2008 with $17.6 million in cash, cash equivalents and marketable securities against $21.1 million at September 30, 2008 and $31.0 million at December 31, 2007. This includes the payment of $500,000 we received on December 15, 2008 as part of the $2.25 million settlement that Cardia, Inc. agreed to pay related to a patent litigation lawsuit. We currently anticipate receiving the remaining $1.25 million during 2009.”
Full Year Results
Revenues for the full year ended December 31, 2008 included about $18,000 of net royalty income, against about $6.9 million of net royalty income for the corresponding period in 2007.
Total worldwide cardiac septal repair implant sales for the full year ended December 31, 2008 were about $17.9 million against about $19.9 million for the same period in 2007. Implant sales in North America for the full year 2008 were about $11.7 million against about $14.2 million for the comparable period of 2007. European implant sales were about $6.1 million for the twelve-month period ended December 31, 2008, against about $5.7 million for the corresponding period in 2007.
Business Guidance
“Several of our promising programs, such as CLOSURE I and BioSTAR(R), are expected to achieve significant milestones during 2009,” said Martin. “Based on the positive response to BioSTAR(R), we have entered new markets in Latin America and believe that we are extending our market share in Europe and Canada.”
“Most importantly, the potential to allow investigators to analyze the data of our CLOSURE I study about one year earlier than originally planned is very exciting,” said Martin. “Since enrollment in the trial began five years ago, more than 90 percent of the data will be at or greater than a two-year follow-up period by November 2009. The CLOSURE I Executive Committee, independent statistical experts and the FDA are determining if that is an appropriate time interval to perform the study data analysis. If so, we would then expect to submit a pre-market approval (PMA) application for the stroke and TIA indication to the FDA during the first quarter of 2010. We believe that the medical community eagerly awaits the answer to whether PFO closure or medical therapy alone provides the best risk benefit for reducing recurrent stroke or TIA.”
Davis said, “For the first quarter of 2009, we are expecting total revenues of about $3.9 to $4.2 million. For full year 2009, we currently anticipate total revenues of about $18 million. With CLOSURE I enrollment complete, and with the recently implemented cost reductions in place, our cash burn rate will decrease significantly in 2009 over 2008 levels. As a result, we expect cash, cash equivalents and marketable securities at December 31, 2009 to be in the range of $6 to $8 million.”