CVTX CV Therapeutics (MM)

CV Therapeutics Reports 2004 Third Quarter Financial Results PALO ALTO, Calif., Oct. 26 /PRNewswire-FirstCall/ -- CV Therapeutics, Inc. (NASDAQ:CVTX) today announced financial results for the third quarter ended September 30, 2004. For the quarter ended September 30, 2004, the Company reported a net loss of $32.8 million, or $1.03 per share, compared to a net loss of $32.3 million, or $1.13 per share, for the same period in 2003. For the nine months ended September 30, 2004, the Company reported a net loss of $101.3 million, or $3.25 per share, compared to a net loss of $75.9 million, or $2.70 per share, for the same period in 2003. Operating expenses for the quarter ended September 30, 2004 increased to $37.4 million from $33.7 million for the same quarter in 2003. Operating expenses increased to $107.1 million for the nine months ended September 30, 2004, from $81.8 million for the same period in 2003. The increase in operating expenses in the third quarter of 2004 compared to the same quarter in 2003 was primarily due to increased contract service expenses for the Company's initiation of additional Phase III Ranexa(TM) (ranolazine) studies and its two ongoing Phase III regadenoson studies, offset in part by a decline in pre-commercialization sales and marketing expenses. The increase in operating expenses for the nine months ended September 30, 2004 compared to the comparable period in 2003 was primarily due to increases in contract service expenses for the studies mentioned above, a small increase in associated research and development headcount, and an increase in general and administrative expenses primarily due to increased headcount. Net interest and other expense for the nine months ended September 30, 2004 increased to a net expense of $7.1 million, compared to net interest and other income of $0.2 million in the same period in 2003, primarily due to a reduction of $3.4 million in interest earned on our investments and to a loss of $3.3 million during the second quarter ended June 30, 2004 on the early retirement of $116.6 million of the Company's outstanding 4.75% convertible subordinated notes due in 2007. The Company recognized collaborative research revenue of $5.6 million for the quarter ended September 30, 2004, compared to $2.2 million for the same period in 2003. For the nine months ended September 30, 2004, the Company recognized collaborative research revenue of $12.8 million, compared to $5.7 million for the same period in 2003. The revenue recognized for each of the periods relates to the reimbursement of certain development costs from a collaborative partner and amortization of up-front milestone payments earned. At September 30, 2004, the Company had cash, cash equivalents and marketable securities of approximately $400.9 million, compared to $430.1 million at December 31, 2003. Company management will webcast a conference call on Tuesday, October 26, 2004 at 5:30 p.m. EDT, 2:30 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 (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. 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 1609419. 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 currently has four compounds in clinical development. CV Therapeutics has received an approvable letter from the United States Food and Drug Administration (FDA) relating to its new drug application for Ranexa for the potential treatment of chronic angina, and has submitted an application for the approval of ranolazine for the potential treatment of chronic angina to the European Medicines Agency. Regadenoson, a selective A2A-adenosine receptor agonist, is being developed for potential use as a pharmacologic stress agent in cardiac perfusion imaging studies. Tecadenoson, an A1-adenosine receptor agonist, is being developed for the potential reduction of rapid heart rate during atrial arrhythmias. Adentri(TM), an A1-adenosine receptor antagonist for the potential treatment of heart failure, is being developed by Biogen Idec Inc. For more information, please visit CV Therapeutics' website at http://www.cvt.com/. CV Therapeutics is a development-stage company. None of the Company's products have been approved for marketing by the FDA or any foreign regulatory authorities. Any products of the Company discussed here are currently under investigation in clinical trials subject to United States Investigational New Drug applications, and as applicable, appropriate clinical trial applications to regulatory authorities outside the United States. Except for the historical information contained herein, the matters set forth in this press release, including statements as to our financial performance and the development and commercialization of our 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, early stage of development; regulatory review and approval of our products; the conduct and timing of clinical trials; the dependence on collaborative and licensing agreements; commercialization of our products; operating at a loss; and other risks detailed from time to time in CVT's SEC reports, including its most recent Annual Report on Form 10-K, and its most recent Quarterly Report on Form 10-Q. CVT 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, 2003 2004 2003 2004 Revenues: Collaborative research $2,224 $5,645 $5,739 $12,849 Operating expenses: Research and development 19,460 27,732 53,551 75,691 Sales and marketing 9,472 4,511 15,527 15,048 General and administrative 4,755 5,184 12,758 16,331 Total operating expenses 33,687 37,427 81,836 107,070 Loss from operations (31,463) (31,782) (76,097) (94,221) Interest and other income (expense), net (842) (988) 203 (7,100) Net loss $(32,305) $(32,770) $(75,894) $(101,321) Basic and diluted net loss per share $(1.13) $(1.03) $(2.70) $(3.25) Shares used in computing basic and diluted net loss per share 28,536 31,793 28,122 31,153 CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands) December 31, September 30, 2003 2004 (A) (unaudited) Assets: Cash, cash equivalents and marketable securities $430,107 $400,908 Other current assets 13,009 20,301 Total current assets 443,116 421,209 Property and equipment, net 16,358 14,779 Other assets 11,921 21,654 Total assets $471,395 $457,642 Liabilities and stockholders' equity: Current liabilities $21,017 $28,353 Convertible subordinated notes 296,250 329,645 Long-term obligations 5,182 6,485 Stockholders' equity 148,946 93,159 Total liabilities and stockholders' equity $471,395 $457,642 (A) Derived from the audited financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2003. DATASOURCE: CV Therapeutics, Inc. CONTACT: investors, Dan Spiegelman, SVP & Chief Financial Officer, +1- 650-384-8509, or Christopher Chai, Treasurer & Executive Director, Investor Relations, +1-650-384-8560, or media, John Bluth, Senior Director, Corporate Communications, +1-650-384-8850, all of CV Therapeutics, Inc. Web site: http://www.cvt.com/

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