PALO ALTO, Calif., Nov. 6 /PRNewswire-FirstCall/ -- CV
Therapeutics, Inc. (NASDAQ:CVTX) today reported financial results
for the third quarter ended September 30, 2007. For the quarter
ended September 30, 2007, the Company reported a net loss of $34.2
million, or $0.58 per share. This compares to a net loss of $62.7
million, or $1.23 per share, for the same quarter in 2006 and $57.6
million, or $0.97 per share, for the prior quarter ended June 30,
2007. For the quarter ended September 30, 2007, the Company
recorded total revenues of $19.8 million which consisted of $18.4
million of net product sales of Ranexa(R) (ranolazine
extended-release tablets) and $1.3 million of collaborative
research revenue. The $18.4 million of net product sales of Ranexa
in the quarter ended September 30, 2007 represents an increase of
20 percent compared to the $15.3 million of net product sales
recorded in the prior quarter ended June 30, 2007 and an increase
of 124 percent compared to the $8.2 million of net product sales in
the same quarter of the prior year. Net product sales recognized in
the quarter ended September 30, 2007 includes $1.1 million
resulting from a reduction in our estimate of future product
returns due to limited actual returns from customers since launch
and other factors which impact our estimate of future returns. The
third quarter 2007 collaborative research revenue includes revenue
primarily related to the reimbursement of certain regadenoson
development costs from our collaborative partner. Total revenues
for the nine months ended September 30, 2007 of $60.4 million
consisted of $45.7 million of net product sales of Ranexa and $14.7
million of collaborative research revenue which includes a $7.0
million milestone payment for submission of a new drug application
for regadenoson as well as reimbursement of certain regadenoson
development costs. This compares to total revenues of $24.1 million
for the same period in the prior year, which consisted of $9.4
million of net product sales of Ranexa, $13.3 million of
collaborative research revenue primarily related to the
reimbursement of certain regadenoson development costs and $1.4
million of co-promotion revenue related to ACEON(R) (perdindopril
erbumine) Tablets, which we ceased co- promoting in the quarter
ended December 31, 2006. Costs and expenses were $53.7 million for
the quarter ended September 30, 2007. This compares to total costs
and expenses of $76.3 million for the same quarter in 2006 and
$83.1 million for the prior quarter ended June 30, 2007. The
decrease in cost and expenses in the quarter ended September 30,
2007 compared to the same quarter in 2006 was primarily due to a
reduction in personnel related expenses related to the
restructuring plan implemented in May 2007, lower research and
development expenses resulting from lower clinical trial expenses
related to the completion of the MERLIN TIMI-36 study of Ranexa and
lower regadenoson research and development expenses, lower Ranexa
sales and marketing expenses and lower ACEON(R) sales and marketing
expenses associated with the end of the ACEON(R) co-promotion
arrangement. These decreases were partially offset by higher cost
of sales due to higher net product sales of Ranexa and an
additional restructuring charge related to excess leased office
space. The decline of total costs and expenses in the quarter ended
September 30, 2007 compared to the prior quarter ended June 30,
2007 was primarily due to a reduction in personnel related expenses
related to the May 2007 restructuring plan, lower sales and
marketing expenses associated with promoting Ranexa, lower
restructuring expenses and lower research and development costs
associated with regadenoson and Ranexa. For the nine months ended
September 30, 2007, total costs and expenses were $207.9 million
compared to total costs and expenses of $233.0 million for the same
period in the prior year. The decrease for the nine months ended
September 30, 2007 compared to the same period in the prior year
was primarily due to lower research and development expenses
resulting from lower clinical trial expenses related to the
completion of the MERLIN TIMI-36 study of Ranexa and lower
regadenoson research and development expense, lower sales and
marketing expenses due to the end of the ACEON(R) co-promotion
arrangement and lower Ranexa sales and marketing expenses. These
decreases were partially offset by costs associated with the
restructuring plan implemented in May 2007, which included
severance benefits, stock-based compensation expense related to
accelerated vesting of employee stock options and forfeiture of
certain stock appreciation rights and costs related to excess
leased office space and higher cost of sales due to higher net
product sales of Ranexa. At September 30, 2007, the Company had
cash, cash equivalents, marketable securities and restricted cash
of $199.5 million compared to $223.7 million at June 30, 2007. Our
total cash utilized for the quarter ended September 30, 2007 was
$24.2 million. This compares to our cash utilized for the prior
quarter of $43.4 million which included $3.3 million in
restructuring expenses paid in the quarter, offset by the benefit
of the non-recurring collaboration milestone payment of $7.0
million from Astellas Pharma US, Inc. In the second quarter,
excluding the impact of these non-recurring items, cash utilized
was $47.1 million. Company management will webcast a conference
call on November 6, 2007 at 4:30 p.m. EST, 1:30 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 (866) 524-6247, and
international callers may participate in the conference call by
dialing (706) 679-3061. Webcast and telephone replays of the
conference call will be available approximately two hours after the
completion of the call through Tuesday, November 13, 2007. 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 20300373. 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
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; reliance on strategic partnerships and collaborations;
uncertainties in drug development; uncertainties regarding
intellectual property; 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, 2007. CV Therapeutics
disclaims any intent or obligation to update these forward-looking
statements. --Tables to follow-- CV THERAPEUTICS, INC. CONSOLIDATED
STATEMENTS OF OPERATIONS DATA (In Thousands, Except Per Share
Amounts) (Unaudited) Three months ended Nine months ended September
30, September 30, 2007 2006 2007 2006 Revenues: Product sales, net
$18,419 $8,164 $45,723 $9,394 Collaborative research 1,344 4,038
14,698 13,283 Co-promotion - - - 1,439 Total revenues 19,763 12,202
60,421 24,116 Costs and expenses (1): Cost of sales 2,609 1,163
6,558 1,516 Research and development 19,055 32,465 75,032 97,152
Selling, general and administrative 30,594 42,684 119,546 134,308
Restructuring charges 1,407 - 6,774 - Total costs and expenses
53,665 76,312 207,910 232,976 Loss from operations (33,902)
(64,110) (147,489) (208,860) Other income (expense), net: Interest
and other income, net 2,847 4,582 10,112 12,100 Interest expense
(3,166) (3,166) (9,498) (9,501) Total other income (expense), net
(319) 1,416 614 2,599 Net loss $(34,221) $(62,694) $(146,875)
$(206,261) Basic and diluted net loss per share $(0.58) $(1.23)
$(2.48) $(4.36) Shares used in computing basic and diluted net loss
per share 59,458 51,067 59,213 47,340 (1) Costs and expenses
include non-recurring stock-based compensation expense related to
the acceleration of stock options and the voluntary forfeiture of
stock appreciation rights as follows: Cost of sales $- $- $109 $-
Research and development - - 4,606 - Selling, general and
administrative - - 8,471 - Total non-recurring stock-based
compensation charges $- $- $13,186 $- Reconciliation of GAAP Items
to Non-GAAP Items (2): Net loss, as reported $(34,221) $(62,694)
$(146,875) $(206,261) Adjustments: Non-recurring stock-based
compensation charges - - 13,186 - Restructuring charges 1,407 -
6,774 - Net loss, non-GAAP $(32,814) $(62,694) $(126,915)
$(206,261) Basic and diluted net loss per share, as reported
$(0.58) $(1.23) $(2.48) $(4.36) Adjustments $0.02 $- $0.34 $- Basic
and diluted net loss per share, non-GAAP(3) $(0.55) $(1.23) $(2.14)
$(4.36) Shares used in computing basic and diluted net loss per
share 59,458 51,067 59,213 47,340 (2) CVT believes that the
non-GAAP financial measures presented in this press release are
useful for investors because these measures provide added insight
into CVT's performance by focusing on results generated by its
ongoing operations. In addition, CVT uses these non-GAAP financial
measures when assessing the performance of its ongoing operations,
in making resource allocation decisions and for planning and
forecasting. (3) The values shown above are exact; totals may not
appear to sum due to rounding. CONSOLIDATED BALANCE SHEET DATA (in
thousands) (unaudited) September 30, 2007 December 31, 2006 Assets:
Cash, cash equivalents, and marketable securities $194,756 $325,226
Other current assets 41,526 40,269 Total current assets 236,282
365,495 Property and equipment, net 20,355 23,919 Other assets
24,696 32,042 Total assets $281,333 $421,456 Liabilities and
stockholders' deficit: Current liabilities $32,560 $62,247
Convertible subordinated notes 399,500 399,500 Other long-term
obligations 5,829 5,507 Stockholders' deficit (156,556) (45,798)
Total liabilities and stockholders' deficit $281,333 $421,456
DATASOURCE: CV Therapeutics, Inc. CONTACT: Investor & Media
Contact, 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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