- Ranexa Revenue Grows 15 Percent Quarter-over-Quarter - PALO ALTO,
Calif., July 31 /PRNewswire-FirstCall/ -- CV Therapeutics, Inc.
(NASDAQ:CVTX) today reported financial results for the second
quarter ended June 30, 2008. For the quarter ended June 30, 2008,
the Company reported a net loss of $4.3 million, or $0.07 per
share. This compares to a net loss of $31.9 million, or $0.53 per
share, for the prior quarter ended March 31, 2008 and $57.6
million, or $0.97 per share, for the same quarter in 2007. For the
quarter ended June 30, 2008, the Company recorded total revenues of
$51.6 million which consisted of $25.4 million of net product sales
of Ranexa(R) (ranolazine extended-release tablets), $4.0 million of
royalty revenue and $22.2 million of license, collaboration and
other revenue. The $25.4 million of net product sales for sales of
Ranexa represents an increase of 15 percent compared to the $22.0
million of net product sales recorded in the prior quarter ended
March 31, 2008. The $4.0 million of royalty revenue includes $2.6
million of amortization of our $175.0 million upfront payment
earned from an investment trust related to TPG-Axon Capital in
exchange for rights to 50 percent of our royalty on North American
sales of Lexiscan(TM) (regadenoson) injection and $1.3 million of
Lexiscan(TM) royalty revenue. The $22.2 million of license,
collaboration and other revenue includes $12.0 million relating to
a milestone payment from Astellas Pharma US. Inc. (Astellas)
associated with the U.S. Food and Drug Administration (FDA)
approval for Lexiscan(TM) and $10.0 million relating to a milestone
payment from TPG-Axon Capital associated with the commercial launch
of Lexiscan(TM). Costs and expenses were $56.8 million for the
quarter ended June 30, 2008. This compares to total costs and
expenses of $53.1 million for the prior quarter ended March 31,
2008 and $83.1 million for the same quarter in 2007. The increase
of total costs and expenses in the quarter ended June 30, 2008
compared to the prior quarter ended March 31, 2008 was primarily
due to higher Ranexa marketing and sales expense. The decrease in
costs and expenses in the quarter ended June 30, 2008 compared to
the same period in 2007 was due in part to $18.6 million of
non-recurring charges relating to the Company's restructuring plan
initiated in May 2007 to lower annual operating expenses. The
balance of the year-over-year decline was primarily due to lower
research and development expenses, reduction in personnel-related
expenses related to cost savings from the May 2007 restructuring
plan and lower marketing and sales expenses. These decreases were
partially offset by higher cost of sales due to higher sales of
Ranexa. During the quarter ended June 30, 2008 the Company had
several unusual events which affected our quarterly cash flow. We
received a $12.0 million milestone from Astellas upon FDA approval
of Lexiscan(TM). We also received two payments totaling $185.0
million from TPG-Axon Capital in exchange for rights to 50 percent
of our royalty on North American sales of Lexiscan(TM). Offsetting
these cash inflows, $48.4 million was used to repurchase $53.0
million face value of our convertible subordinated notes.
Additionally, the Company made an estimated tax payment of $3.2
million for alternative minimum tax primarily as a result of the
cash received from TPG-Axon Capital. At June 30, 2008, the Company
had cash, cash equivalents, marketable securities and restricted
cash of $274.7 million compared to $151.0 million at March 31,
2008. Excluding the unusual cash items above, our cash utilized for
the quarter ended June 30, 2008 was $21.7 million. This compares to
our cash utilized for the prior quarter of $28.0 million. The
decrease in cash utilization in the quarter ended June 30, 2008
compared to the prior quarter was due primarily to the timing of
certain compensation and payroll related tax payments paid out in
the prior quarter and higher cash receipts in the current quarter
associated with higher quarter-over-quarter revenue. Company
management will webcast a conference call on July 31, 2008 at 5:00
p.m. EDT, 2:00 p.m. PDT, 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) 524-6241, 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 Thursday, August 7, 2008. 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 56235490. About CV Therapeutics CV Therapeutics, Inc.,
headquartered in Palo Alto, California, is a biopharmaceutical
company primarily focused on applying molecular cardiology to the
discovery, development and commercialization of novel, small
molecule drugs for the treatment of cardiovascular diseases. CV
Therapeutics Ltd. is the company's European subsidiary based in the
United Kingdom. CV Therapeutics' approved products in the United
States include Ranexa(R) (ranolazine extended-release tablets),
indicated for the treatment of chronic angina in patients who have
not achieved an adequate response with other antianginal drugs, and
Lexiscan(TM) (regadenoson) injection for use as a pharmacologic
stress agent in radionuclide myocardial perfusion imaging in
patients unable to undergo adequate exercise stress. Ranolazine is
approved for use in the European Union as add-on therapy for the
symptomatic treatment of patients with stable angina pectoris who
are inadequately controlled or intolerant to first-line antianginal
therapies. 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 March 31, 2008. 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 Six months ended June 30,
June 30, 2008 2007 2008 2007 Revenues: Product sales, net $25,427
$15,315 $47,472 $27,304 Royalties 3,956 - 3,956 - License,
collaboration and other 22,237 10,093 23,003 13,354 Total revenues
51,620 25,408 74,431 40,658 Costs and expenses: Cost of sales 4,351
2,392 7,734 3,949 Research and development 17,151 28,799 34,396
55,977 Selling, general and administrative 35,342 46,504 67,792
88,952 Restructuring charges - 5,367 (7) 5,367 Total costs and
expenses 56,844 83,062 109,915 154,245 Loss from operations (5,224)
(57,654) (35,484) (113,587) Other income (expense), net: Interest
and other income, net 6,333 3,222 7,868 7,265 Interest expense
(3,661) (3,166) (6,835) (6,332) Total other income (expense), net
2,672 56 1,033 933 Loss before income taxes (2,552) (57,598)
(34,451) (112,654) Income tax provision 1,742 - 1,742 - Net loss
$(4,294) $(57,598) $(36,193) $(112,654) Basic and diluted net loss
per share $(0.07) $(0.97) $(0.60) $(1.91) Shares used in computing
basic and diluted net loss per share 60,856 59,223 60,706 59,089
Reconciliation of GAAP Items to Non-GAAP Items: Net loss, GAAP as
reported $(4,294) $(57,598) $(36,193) $(112,654) Adjustments:
Non-recurring stock-based compensation charges - 13,186 - 13,186
Restructuring charges - 5,367 - 5,367 Net loss, non-GAAP $(4,294)
$(39,045) $(36,193) $(94,101) Basic and diluted net loss per share,
as reported $(0.07) $(0.97) $(0.60) $(1.91) Adjustments $- $0.31 $-
$0.31 Basic and diluted net loss per share, non-GAAP** $(0.07)
$(0.66) $(0.60) $(1.59) Shares used in computing basic and diluted
net loss per share 60,856 59,223 60,706 59,089 **The values shown
above are exact; totals may not appear to sum due to rounding
CONSOLIDATED BALANCE SHEET DATA (In Thousands) (Unaudited) June 30,
2008 December 31, 2007 Assets: Cash, cash equivalents, and
marketable securities $272,313 $174,245 Other current assets 40,874
41,825 Total current assets 313,187 216,070 Property and equipment,
net 16,639 19,131 Other assets 20,815 23,635 Total assets $350,641
$258,836 Liabilities and stockholders' deficit: Current liabilities
$46,534 $39,183 Convertible subordinated notes 346,500 399,500
Deferred revenue 159,805 - Other long-term obligations 4,675 5,551
Stockholders' deficit (206,873) (185,398) Total liabilities and
stockholders' deficit $350,641 $258,836 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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