CVTX CV Therapeutics (MM)

- 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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