MENLO PARK, Calif., Aug. 6 /PRNewswire-FirstCall/ -- XTENT, Inc. (Nasdaq: XTNT) today reported financial results for the second quarter and six months ended June 30, 2008 and provided an update on its business.
The company reported a net loss of $12.9 million, or $0.56 per share, for the second quarter of 2008, compared to a net loss of $9.5 million, or $0.42 per share, for the second quarter of 2007. The company's net loss for the second quarter of 2008 was based on weighted average shares outstanding of 23.0 million as compared to 22.6 million weighted average shares outstanding for the second quarter of 2007. For the six months ended June 30, 2008, XTENT had a net loss of $25.3 million, compared to $17.4 million for the same period last year. As of June 30, 2008, XTENT had cash, cash equivalents and short-term investments of $34.4 million.
Research and development expenses increased to $9.8 million in the second quarter of 2008 from $7.7 million for the same period in 2007, primarily due to an increased number of research and development personnel, expenditures for prototype parts and supplies as well as costs incurred for clinical trials. General and administrative expenses were $3.3 million in the second quarter of 2008 versus $2.8 million for the same period in 2007, primarily due to an increase in personnel costs related to the hiring of additional employees as well as consulting, legal, professional services and other administrative costs associated with operating as a public company. Research and development expenses for the six month period ended June 30, 2008 totaled $19.2 million, compared to $13.9 million for the same period last year. General and administrative expenses for the six months ended June 30, 2008 totaled $6.8 million compared to $5.3 million for the same period in 2007.
On July 9, 2008, XTENT announced the implementation of cost reduction initiatives through a workforce reduction of approximately 34 percent. The company expects to incur approximately $300,000 to $400,000 in expenses in connection with this workforce reduction including approximately $100,000 of non-cash expenses. Most of the expenses will be incurred during the third quarter of 2008. Average cost savings from the workforce reduction initiative, combined with other cost saving initiatives planned by the company, is anticipated to be approximately $1.3 million each month.
"We recently conducted a review of our business and made the difficult decision of reducing headcount in order to ensure that we remain in a strong position to bring our Custom NX(R) drug eluting stent (DES) system to the millions of patients worldwide who suffer from coronary artery disease," said Gregory D. Casciaro, XTENT's President and Chief Executive Officer. "We continue to be pleased with the safety profile and efficacy data of Custom NX in today's real-world patients, and look forward to providing additional long term follow up data at the upcoming Transcatheter Cardiovascular Therapeutics meeting in October."
Second Quarter 2008 Highlights
-- Presented positive CUSTOM III six-month follow-up data during the Late Breaking Trials Session at EuroPCR.
-- Received EuroIntervention award for CUSTOM I two-year results at EuroPCR.
XTENT also announced that it recently received a response from the Medicine Evaluations Board (MEB) through its designated European Notified Body regarding its CE Mark application for Custom NX. The MEB has indicated that it may require additional clinical data, including a randomized trial. The company is working with the Notified Body to respond to questions included in the MEB's letter and expects to meet with a panel from the MEB during the fourth quarter of this year.
"We expected to receive questions from the MEB which we believe is typical of most initial submissions," commented Casciaro. "We are working expeditiously to respond to their questions. The opportunity for Custom NX in select non-U.S. markets, including Europe and Asia-Pacific, remains significant and attractive, and we are exploring strategic options related to the distribution of Custom NX in these markets."
Casciaro added, "In the U.S., we are engaged in ongoing discussions with the Food and Drug Administration (FDA) in order to obtain approval of our application for an investigational device exemption (IDE) to commence pivotal trials. We have established an agreed upon timeline of deliverables and, while we believe we are on track to receive approval of our IDE application before the end of 2008, we now expect to commence our pivotal trials in 2009."
XTENT, Inc. is a medical device company focused on developing and commercializing innovative customizable drug eluting stent (DES) systems for the treatment of coronary artery disease (CAD). CAD is the most common form of cardiovascular disease and the number one cause of death in the United States and Europe. XTENT(R) Custom NX(R) DES Systems are designed to enable the treatment of single lesions, long lesions and multiple lesions of varying lengths and diameters, in one or more arteries with a single device. Note: XTENT(R) Custom NX(R) DES Systems have not been approved for sale by any regulatory authority.
Forward Looking Statements
This press release contains forward-looking statements within the
meaning of the U.S. Private Securities Litigation Reform Act of 1995.
Statements in this press release regarding XTENT's business that are not
historical facts may be "forward-looking statements" that involve risks and
uncertainties. Specifically, these statements include, but are not limited
to those concerning: XTENT's expectations with respect to the timing of its
regulatory filings, the timing of regulatory approvals, the timing of the
commercialization of its products, the timing of the initiation of its U.S.
clinical trial, and the timing and amount of any savings that may result
from the company's cost reduction initiatives. Forward-looking statements
are based on management's current, preliminary expectations, and are
subject to risks and uncertainties that could cause actual results to
differ from the results predicted and which are included in the "Risk
Factors" section of XTENT's most recent quarterly report on Form 10-Q for
the quarter ended March 31, 2008. This quarterly report was filed with the
SEC on May 13, 2008, and is available on the company's investor relations
website at http://www.xtentinc.com and on the SEC's website at
http://www.sec.gov. Undue reliance should not be placed on forward-looking
statements, which speak only as of the date they are made. XTENT undertakes
no obligation to update publicly any forward-looking statements to reflect
new information, events or circumstances after the date they were made, or
to reflect the occurrence of unanticipated events.
(a development stage company)
Condensed Statements of Operations
(unaudited; in thousands, except per share amounts)
Three Months Ended Six Months Ended
June 30, June 30,
2008 2007 2008 2007
Research and development (1) $9,818 $7,704 $19,239 $13,927
General and administrative (1) 3,331 2,801 6,773 5,262
Total operating expenses 13,149 10,505 26,012 19,189
Loss from operations (13,149) (10,505) (26,012) (19,189)
Interest and other income, net 263 1,049 669 1,798
Net loss $(12,886) $(9,456) $(25,343) $(17,391)
Net loss per share - basic and
diluted $(0.56) $(0.42) $(1.10) $(0.93)
Weighted-average common shares
outstanding used in per share
calculation 23,033 22,551 22,978 18,649
(1) Includes the following stock-based compensation charges:
Research and development $393 $348 $781 $736
General and administrative $695 $413 $1,345 $832
(a development stage company)
Condensed Balance Sheets
(unaudited, in thousands)
June 30, 2008 December 31, 2007
Cash, cash equivalents and short term
investments $34,427 $57,760
Working capital 31,355 54,581
Total assets 39,507 62,415
Deficit accumulated during the
development stage (118,203) (92,860)
Total stockholders' equity 35,345 58,331
|SOURCE XTENT, Inc.|
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