MENLO PARK, Calif., Feb. 19 /PRNewswire-FirstCall/ -- XTENT, Inc. (Nasdaq: XTNT) today reported financial results for the fourth quarter and year ended December 31, 2007.
The company reported a net loss and net loss attributable to common stockholders of $11.9 million, or $0.52 per share, for the fourth quarter of 2007, compared to a net loss and net loss attributable to common stockholders of $7.2 million, or $2.46 per share, for the same period in 2006. The company's net loss per share attributable to common stockholders for the fourth quarter of 2007 was based on weighted average shares outstanding of 22.8 million as compared to 2.9 million weighted average shares outstanding for the quarter ended December 31, 2006.
For the year ended December 31, 2007, XTENT had a net loss of $38.8 million, compared to $25.0 million for the same period in 2006. The net loss attributable to common stockholders was $38.8 million for the year ended December 31, 2007, compared to $38.1 million for the same period in 2006. At December 31, 2007, XTENT had cash, cash equivalents and short-term investments of $57.8 million.
Research and development expenses increased to $9.2 million in the fourth quarter of 2007 from $5.5 million for the same period in 2006, 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 $3.4 million in the fourth quarter of 2007 versus $2.0 million for the same period in 2006, primarily due to an increase in personnel costs related to the hiring of additional employees as well as consulting and professional services associated with operating as a public company.
Research and development expenses for the year ended December 31, 2007, totaled $30.9 million, compared to $18.9 million for the same period in 2006. General and administrative expenses for the year ended December 31, 2007, totaled $11.3 million, compared to $7.3 million for the same period in 2006.
"2007 was a year of tremendous progress for XTENT as we reported additional positive clinical data from our CUSTOM I and CUSTOM II trials, and completed enrollment in our CUSTOM III clinical trial," said Gregory D. Casciaro, XTENT's President and CEO. "We expect 2008 to be a very exciting year for the company as we prepare for CE Mark approval and commercial launch in Europe in the second half of the year. We are actively working on responses to the questions we received from the Food and Drug Administration regarding our IDE submission and expect to commence enrollment in our U.S. clinical trial later this year."
In addition to moving ahead with commercialization and regulatory goals, the company expects to announce long-term follow-up data from its CUSTOM I and CUSTOM II trials, as well as six month data and one year data from the CUSTOM III trial.
The company expects to have operating expenses in the range of $25 to
$30 million during the first half of 2008.
In 2007, XTENT:
-- Raised over $68 million upon completion of its Initial Public Offering
-- Presented positive six-month follow-up data from the CUSTOM II clinical
trial, which assessed the safety and efficacy of the company's Custom
NX(R) drug-eluting stent (DES) system for the treatment of long and
multiple lesions in patients with coronary artery disease, at a
late-breaking session at the EuroPCR meeting in May
-- Presented positive two-year follow-up data from the CUSTOM I clinical
trial and positive one-year follow-up data from the CUSTOM II clinical
trial, both at TCT in October
-- Completed enrollment of the CUSTOM III clinical trial
-- Introduced design enhancements to the Custom NX DES system to allow for
greater ease-of-use by clinicians
-- Submitted an IDE application to the FDA to initiate its CUSTOM IV
-- Submitted the design dossier for CE Mark
-- Expanded its Menlo Park, California facilities to prepare for
Conference Call and Webcast Information
The company will hold a conference call today at 2 p.m., Pacific Time (5 p.m. Eastern Time). The call will be hosted by Gregory D. Casciaro, XTENT's President and Chief Executive Officer, and Tim Kahlenberg, Chief Financial Officer.
The teleconference can be accessed via the investor relations section of the Company's website at http://investor.xtentinc.com/events.cfm or by calling 877 627-6580 (domestic), 719 325-4903 (international). Please dial in or access the website 5 to 10 minutes prior to the beginning of the call.
An online archive of the webcast will be available for a minimum of three months by accessing the investor relations portion of the company's website at http://investor.xtentinc.com.
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 and the timing of the initiation of its
U.S. clinical trial. 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 September
30, 2007. This quarterly report was filed with the SEC on November 2, 2007,
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 Year Ended
December 31, December 31,
2007 2006 2007 2006
Research and development (1) $9,194 $5,520 $30,888 $18,923
General and administrative (1) 3,375 1,981 11,269 7,258
Total operating expenses 12,569 7,501 42,157 26,181
Loss from operations (12,569) (7,501) (42,157) (26,181)
Interest and other income, net 705 336 3,363 1,137
Net loss (11,864) (7,165) (38,794) (25,044)
Deemed dividend related to
beneficial conversion feature of
redeemable convertible preferred
stock - - - (13,095)
Net loss attributable to common
stockholders $(11,864) $(7,165) $(38,794) $(38,139)
Net loss per share attributable to
common stockholders - basic and
diluted $(0.52) $(2.46) $(1.87) $(13.96)
Weighted-average common shares
outstanding used in per share
calculation 22,790 2,909 20,703 2,732
(1) Includes the following stock-
based compensation charges:
Research and development $460 $408 $1,490 $1,258
General and administrative $766 $408 $2,088 $986
(a development stage company)
Condensed Balance Sheets
(unaudited, in thousands)
December 31, December 31,
Cash and cash equivalents and short
term investments $57,760 $23,105
Working capital 54,581 21,066
Total assets 62,415 27,121
Redeemable convertible preferred stock - 75,593
Deficit accumulated during the
development stage (92,860) (54,066)
Total stockholders' equity (deficit) 58,331 (50,780)
|SOURCE XTENT, Inc.|
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