CV Therapeutics Reaffirms Financial Guidance
August 07 2007 - 8:00AM
PR Newswire (US)
PALO ALTO, Calif., Aug. 7 /PRNewswire-FirstCall/ -- CV
Therapeutics, Inc. (NASDAQ:CVTX) today reaffirmed its financial
guidance for the second half of 2007 and the first half of 2008. As
announced last week, the Company estimates that operating expenses,
not including cost of sales, will be approximately $105 to $110
million for the second half of 2007. This figure only provides
guidance on operating expenses. Product and collaboration revenues,
which are not reflected in this operating expense figure, would
offset a portion of operating expenses. In the second quarter of
2007, the Company reported $25.4 million in total revenue,
including $15.3 million in net product revenue for Ranexa(R)
(ranolazine extended-release tablets). The $15.3 million in net
product revenue in the second quarter of 2007 represented an
increase of 28 percent from the first quarter of 2007. Net product
revenue in the first quarter of 2007 increased 33 percent from the
fourth quarter of 2006. For purposes of illustration only, if the
Company's operating expenses, not including cost of sales, for the
third quarter of 2007 were approximately $50 million, consistent
with current guidance, and net product and collaboration revenues
were consistent with the second quarter of 2007 (excluding the $7.0
million in collaborative revenue associated with the milestone
payment we received from Astellas Pharma US, Inc. (Astellas) in the
second quarter of 2007), the Company's net loss would be
approximately $35 million in the third quarter of 2007. The Company
also reaffirmed that, after the restructuring completed in the
second quarter, its current cash position should be sufficient for
approximately two years of operations, assuming that prescriptions
for Ranexa continue to grow at the rate observed prior to the
publication of the MERLIN TIMI-36 clinical study in April 2007, and
assuming that regadenoson is approved by the FDA in 2008 and that
the Company receives modest royalties under the licensing and
collaboration arrangement with Astellas for that program. At June
30, 2007, the Company had cash, cash equivalents, marketable
securities and restricted cash of approximately $223.7 million.
About CV Therapeutics CV Therapeutics, Inc., headquartered in Palo
Alto, California, is a biopharmaceutical company focused on
applying molecular cardiology to the discovery, development and
commercialization of novel, small molecule drugs for the treatment
of cardiovascular diseases. CV Therapeutics' approved product,
Ranexa(R) (ranolazine extended-release tablets), is indicated for
the treatment of chronic angina in patients who have not achieved
an adequate response with other antianginal drugs, and should be
used in combination with amlodipine, beta-blockers or nitrates. CV
Therapeutics also has other clinical and preclinical drug
development candidates and programs, including regadenoson, which
is being developed for potential use as a pharmacologic stress
agent in myocardial perfusion imaging studies, and CVT-6883, which
is being developed as a potential treatment for cardiopulmonary
diseases. Regadenoson and CVT-6883 have not been determined by any
regulatory authorities to be safe or effective in humans for any
use. Except for the historical information contained herein, the
matters set forth in this press release, including statements as to
operating expenses, are forward-looking statements within the
meaning of the "safe harbor" provisions of the Private Securities
Litigation Reform Act of 1995. These forward-looking statements are
subject to risks and uncertainties that may cause actual results to
differ materially, including operating losses and fluctuations in
operating results; capital requirements; regulatory review and
approval of our products; special protocol assessment agreement;
the conduct and timing of clinical trials; commercialization of
products; market acceptance of products; product labeling;
concentrated customer base; and other risks detailed from time to
time in CV Therapeutics' SEC reports, including its Quarterly
Report on Form 10-Q for the quarter ended March 31, 2007. CV
Therapeutics disclaims any intent or obligation to update these
forward-looking statements. DATASOURCE: CV Therapeutics, Inc.
CONTACT: Investors and Media, John Bluth, Executive Director,
Corporate Communications & Investor Relations, of CV
Therapeutics, Inc., +1-650-384-8850 Web site: http://www.cvt.com/
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