Two days after reporting plans for a public offering, CV Therapeutics Inc. raised $85.5 million, selling more shares than originally intended but at a lower price.
The Palo Alto, Calif.-based company said Monday it would offer 7.5 million shares, noting that its stock closed at $10.85 Friday. Instead, CV Therapeutics agreed to sell 9 million shares at $9.50, a discount to Tuesday's closing price of $9.75.
Shares (NASDAQ:CVTX) rose 14 cents Wednesday to close at $9.89.
A 30-day overallotment option involving about 1.4 million additional shares granted to underwriters could result in $12.8 million more in gross proceeds. Underwriters include joint lead managers and bookrunners Lehman Brothers Inc. and Merrill Lynch & Co., both of New York.
CV declined comment due to an SEC-imposed quiet period. In its prospectus filed with the SEC, the company said it intends to use net proceeds for general corporate purposes, including the commercialization of its products, developing regadenoson and other products, manufacturing activities and to prepare regulatory filings, as well as to reduce its debts and to fund acquisitions or investments.
Ranexa (ranolazine extended-release tablets) is one of the company's two marketed products, which received FDA approval in January, making it the first new angina drug cleared for U.S. marketing in more than 20 years. It is indicated for second-line use in combination with the calcium channel blocker amlodipine, beta-blockers or nitrates. The drug acts by inhibiting the late sodium current, therefore preventing calcium overload in the heart, and its label currently addresses about 10 percent to 25 percent of the 6.5 million angina patients. Launched in March, it earned the company $1.2 million in the second quarter. (See BioWorld Today, Jan. 31, 2006.)
Sales could grow significantly if CV is able to expand the label to include treatment of first-line chronic angina, and for the hospital-based and long-term prevention of acute coronary syndrome. A Phase III study - MERLIN TIMI-36 (Metabolic Efficiency with Ranolazine for Less Ischemia in Non-ST Elevation Acute Coronary Syndromes) - has completed enrollment. If Ranexa treatment is not associated with an adverse trend in death or arrhythmia, compared with placebo, the trial could support approval of Ranexa as a first-line angina therapy. It would support approval in the ACS indication if it hits its primary endpoint. Data are expected in spring 2007.
CV Therapeutics also hopes to file within six to nine months a marketing authorization application in Europe to gain approval of Ranexa for chronic angina. It withdrew a previous MAA in 2005, and the new filing would include additional data, but not from the MERLIN study, as the company doesn't plan to pursue the expanded indications overseas.
The company's second marketed product, ACEON (perindopril erbumine tablets), is approved to reduce the risk of cardiovascular mortality or nonfatal myocardial infarction in patients with stable coronary artery disease and to treat essential hypertension. It is partnered with Solvay Pharmaceuticals Inc., of Marietta, Ga., through an agreement signed in December 2004 when ACEON was approved for only the hypertension indication. It gained approval for the coronary artery disease indication last August. Co-promotion revenue going to CV Therapeutics amounted to $800,000 in the second quarter of this year.
While CV is pursuing several other cardiovascular candidates at various stages of preclinical and early clinical development, its most advanced drug, regadenoson, completed a Phase III trial, meeting its primary endpoint, in August 2005. A selective A2A-adenosine receptor agonist designed as a pharmacologic agent in myocardial perfusion imaging studies, regadenoson is in a second Phase III trial, with data expected in the fourth quarter. If results are positive, CV would submit a new drug application for the product, which is partnered in the U.S. with Astellas Pharma US Inc., a subsidiary of Tokyo-based Astellas Pharma Inc. CV holds all rights outside of the U.S.
As of June 30, CV had cash, cash equivalents, marketable securities and restricted cash of about $330.6 million. For the second quarter, it reported a net loss of $73.1 million, or $1.59 per share. The company has forecast operating expenses for 2006 to be in the range of $310 million to $330 million.
In April, CV secured a $200 million line of credit, good for three years, through stock sales to Azimuth Opportunity Ltd. In June, it signed a potential $345 million cardiovascular agreement with PTC Therapeutics Inc., of South Plainfield, N.J., to use PTC's Gene Expression Modulation by Small-Molecules (GEMS) technology to develop orally bioavailable small molecules. Together, the companies are selecting five targets, including those known to raise HDL and be involved in dyslipidemia and diabetes. (See BioWorld Today, April 20, 2006, and June 13, 2006.)
Founded in 1990, CV went public in November 1996. Its shares have decreased steadily in the last year from a 52-week high of $29.79 to less than $10.
Following the public offering, the company has 55.3 million shares outstanding.