PALO ALTO, Calif., Oct. 31 /PRNewswire-FirstCall/ -- CV
Therapeutics, Inc. (NASDAQ:CVTX) today reported financial results
for the three and nine months ended September 30, 2006. For the
quarter ended September 30, 2006, the Company reported a net loss
of $62.7 million, or $1.23 per share. This compares to a net loss
of $55.9 million, or $1.26 per share, for the same quarter in 2005
and to a net loss of $73.1 million or $1.59 per share, for the
prior quarter ended June 30, 2006. For the nine months ended
September 30, 2006, the Company reported a net loss of $206.3
million, or $4.36 per share, compared to a net loss of $153.9
million, or $3.98 per share, for the nine months ended September
30, 2005. At September 30, 2006, the Company had cash, cash
equivalents, marketable securities and restricted cash of
approximately $373.3 million, compared to $481.8 million at
December 31, 2005. For the quarter ended September 30, 2006, the
Company recorded $8.2 million of net product revenue for sales of
Ranexa(R) (ranolazine extended- release tablets), compared to net
product revenue of $1.2 million for the prior quarter ended June
30, 2006. The $8.2 million of Ranexa product revenue recorded in
the quarter ended September 30, 2006 included approximately $5.0
million related to product sales made in the quarter ended March
31, 2006, which was deferred due to product return privileges that
expired in the quarter ended September 30, 2006. The Company
received FDA approval for Ranexa on January 27, 2006 and commenced
commercial product sales of Ranexa in March 2006. The Company also
recognized collaborative research revenue of $4.0 million for the
quarter ended September 30, 2006. Collaborative research revenue
recognized primarily relates to the reimbursement of certain
regadenoson development costs from a collaborative partner and
amortization of up-front payments earned. There was no co-promotion
revenue recognized for the quarter ended September 30, 2006 related
to sales of ACEON(R) (perindopril erbumine) Tablets since ACEON(R)
product revenues in the quarter did not exceed the baseline
specified in the amended co-promotion agreement with Solvay
Pharmaceuticals, Inc. Total costs and expenses were $76.3 million
for the quarter ended September 30, 2006. This compares to total
costs and expenses of $59.4 million for the same quarter in 2005
and $80.4 million for the prior quarter ended June 30, 2006. For
the nine months ended September 30, 2006, total costs and expenses
were $233.0 million compared to $167.6 million for the same period
in the prior year. The increase in total costs and expenses for the
quarter ended September 30, 2006 compared to the same period in the
prior year was primarily due to higher selling, general and
administrative expenses associated with the Company's marketing of
Ranexa, greater expenses associated with the Company's national
cardiovascular specialty sales force (which was still being
recruited in 2005), higher outside clinical trial expenses related
to Phase 3 Ranexa development and other research programs and
higher personnel related expenses including stock-based
compensation in various functional areas to support the Company's
increased commercialization and business activities. These
increases were partially offset by lower marketing expenses related
to the co-promotion of ACEON(R). The decrease in total costs and
expenses for the quarter ended September 30, 2006 compared to the
prior quarter ended June 30, 2006 was primarily due to lower
marketing expenses related to the co-promotion of ACEON(R), lower
external general and administrative expenses and lower outside
contract services expense for research and development activities
related primarily to Ranexa and regadenoson. The increase in total
costs and expenses for the nine months ended September 30, 2006
compared to the same period in the prior year was primarily due to
higher selling, general and administrative expenses associated with
promotion activities related to Ranexa and the Company's national
cardiovascular specialty sales force (which was still being
recruited in 2005), higher expenses incurred to market Ranexa and
higher personnel related expenses, including stock-based
compensation, in various functional areas to support the Company's
increased commercialization and business activities. These
increases were partially offset by lower outside contract expenses
for Phase 3 regadenoson development and lower marketing expenses
related to the co-promotion of ACEON(R). The Company sent a notice
of termination of the co-promotion agreement with Solvay
Pharmaceuticals in October 2006 and has concluded its promotion of
ACEON(R). We do not anticipate booking any additional co-promotion
revenue related to sales of ACEON(R), and there are no future
financial commitments for the Company related to the termination of
the co-promotion agreement. Additionally, we do not expect the
conclusion of the ACEON(R) co-promotion activities to have a
material impact on the total sales and marketing expenses of the
Company going forward. Company management will webcast a conference
call on October 31, 2006 at 5:00 p.m. EST, 2:00 p.m. PST, on the
Company's website. To access the live webcast, please log on to the
Company's website at http://www.cvt.com/ and go to the Investor
Information section. Alternatively, domestic callers may
participate in the conference call by dialing (888) 370-6121, and
international callers may participate in the conference call by
dialing (706) 679-7163. Webcast and telephone replays of the
conference call will be available approximately two hours after the
completion of the call through Tuesday, November 7, 2006. Domestic
callers can access the replay by dialing (800) 642-1687, and
international callers can access the replay by dialing (706)
645-9291; the PIN access number is 8804902. 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 asthma and other
conditions. 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 research and development and commercialization of products,
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 June 30, 2006. CV Therapeutics disclaims
any intent or obligation to update these forward-looking
statements. CV THERAPEUTICS, INC. CONDENSED CONSOLIDATED STATEMENTS
OF OPERATIONS (in thousands, except per share amounts) (unaudited)
Three months ended Nine months ended September 30, September 30,
2006 2005 2006 2005 Revenues: Product sales, net $8,164 $-- $9,406
$-- Collaborative research 4,038 4,142 13,271 15,519 Co-promotion
-- -- 1,439 -- Total operating revenues 12,202 4,142 24,116 15,519
Costs and expenses: Cost of sales 1,163 -- 1,516 -- Research and
development 32,465 27,762 97,152 94,468 Selling, general and
administrative 42,684 31,646 134,308 73,150 Total costs and
expenses 76,312 59,408 232,976 167,618 Loss from operations
(64,110) (55,266) (208,860) (152,099) Other income (expense), net:
Interest and other income, net 4,582 3,528 12,100 8,034 Interest
expense (3,166) (4,182) (9,501) (9,878) Total other income
(expense), net 1,416 (654) 2,599 (1,844) Net loss $(62,694)
$(55,920) $(206,261) $(153,943) Basic and diluted net loss per
share $(1.23) $(1.26) $(4.36) $(3.98) Shares used in computing
basic and diluted net loss per share 51,067 44,437 47,340 38,712
CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands) (unaudited)
September 30, 2006 December 31, 2005 (A) Assets: Cash, cash
equivalents, and marketable securities $359,877 $460,183 Other
current assets 32,318 26,883 Total current assets 392,195 487,066
Property and equipment, net 23,501 20,491 Other assets 32,885
25,004 Total assets $448,581 $532,561 Liabilities and stockholders'
equity (deficit): Current liabilities $47,510 $63,527 Convertible
subordinated notes 399,500 399,500 Other long-term obligations
5,483 8,544 Stockholders' equity (deficit) (3,912) 60,990 Total
liabilities and stockholders' equity (deficit) $448,581 $532,561
(A) Derived from the audited financial statements included in our
Annual Report on Form 10-K for the fiscal year ended December 31,
2005. Certain reclassifications have been made to prior period
balances to conform to the current presentation. DATASOURCE: CV
Therapeutics, Inc. CONTACT: John Bluth, Senior Director, Corporate
Communications & Investor Relations of CV Therapeutics, Inc.,
+1-650-384-8850 Web site: http://www.cvt.com/
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