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 nine months ended September 30, 2009.
Third-Quarter Results
Third-quarter 2009 total revenues were approximately $3.0 million compared with approximately $4.2 million for the quarter ended September 30, 2008.
Cardiac septal repair implant sales in North America for the third quarter of 2009 were approximately $2.3 million compared with approximately $3.0 million in the third quarter of 2008. Implant sales outside of North America in the third quarter of 2009 were approximately $700,000 compared with $1.1 million in the corresponding period of 2008.
For the third quarter of 2009, NMT narrowed its net loss to approximately $2.9 million, or $0.22 per share, compared with a net loss of approximately $4.4 million, or $0.33 per share, for the corresponding period in 2008.
Comments on the Quarter
“Total revenues were down approximately 28 percent year-over-year; however, given the number of ongoing clinical trials and competitive market conditions in Europe, they were in line with our expectations,” said President and Chief Executive Officer Frank Martin. “The challenging global economy, combined with the tightly managed hospital inventories, has continued to impact our sales performance. In addition, outside of North America we are continuing to transition from direct sales to distribution partnerships in several key markets while expanding into new territories. However, several of our recently established international territories are not yet contributing revenue due to the process to complete product registrations in those markets. Once this lengthy process is complete, we expect our expanded presence to drive revenues.”
“During the quarter we announced our decision to accelerate the data analysis timing of our pivotal U.S. patent foramen ovale (PFO)/stroke and transient ischemic attack (TIA) trial – CLOSURE I,” said Martin. “Upon the approval of the CLOSURE I Executive Committee and the U.S. Food and Drug Administration (FDA), we will now initiate the data analysis in April 2010, six months earlier than originally planned. We believe that commencing the data review in April 2010 will allow us to submit a Pre-Market Approval (PMA) application during the third quarter of 2010, assuming a positive outcome.”
Chief Operating Officer Richard E. Davis said, “Operationally, we continue to be effective at managing our capital resources and inventory levels while minimizing our expenses. We will continue to be aggressive in this area and make additional adjustments as appropriate. For the first nine months of 2009, we lowered our total operating costs by more than 20 percent, or more than $5 million. At September 30, 2009, cash and cash equivalents were approximately $9.0 million.”
Year-To-Date Results
Total revenues for the nine months ended September 30, 2009 were approximately $9.7 million compared with approximately $13.4 million for the same period in 2008.
Cardiac septal repair implant sales in North America for the first nine months of 2009 were approximately $7.0 million compared with approximately $8.7 million for the nine-month period ended September 30, 2008. Implant sales outside of North America were approximately $2.7 million for the nine-month period ended September 30, 2009 compared with approximately $4.7 million for the same period in 2008.
The net loss for the nine months ended September 30, 2009 was reduced to approximately $10.5 million, or $0.80 per share, compared with a net loss of approximately $13.9 million, or $1.07 per share, for the corresponding period in 2008.
Business Outlook
“Our CLOSURE I trial remains the top priority for NMT,” Martin said. “We anticipate that by the time we are prepared to submit our PMA during the third quarter of 2010, 100 percent of the randomized patient follow-up data will be available. We are all eager to better understand the possible connection between PFO and stroke and TIA. Management continues to be optimistic that the results will support PFO closure with our STARFlex® device for the stroke and TIA indication versus alternative treatments.”
“We are also confident that the steps we are taking to expand our presence overseas will contribute to increased sales and provide more significant long-term growth,” said Martin. “We recently entered into a distribution arrangement in Germany with Nicolai, a partner of the Werfen Group, a leading international distributor in the healthcare industry. We currently plan to continue executing this distribution strategy in a number of overseas markets in order to capitalize on these territories.”
Davis concluded, “We currently are expecting total revenues of $13 to $14 million for the full year 2009. Going forward, we will continue to carefully manage our capital while strategically funding our R&D efforts in order to maintain our technological leadership in the marketplace. We currently expect cash and cash equivalents at year-end to be approximately $6 million. In addition, we also have a $4 million credit facility available to us, which provides us with additional financial flexibility, but we will also continue to review financing alternatives to raise additional capital, if necessary.”
Conference Call Reminder
Management will conduct a conference call at 9:30 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 https://www.gore.com/. The conference call also may be accessed by dialing (877) 709-8155 or (201) 689-8881. 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.
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