Receive Email Alerts View Upcoming Events

Annual Reports

To Our Shareholders

CV Therapeutics is at an historic juncture, as we are in the midst of commercializing 10 years of R&D investment totaling approximately $800 million. In the coming weeks and months, we hope to have new product approvals for regadenoson in the U.S. and for ranolazine in Europe. We could also see significant expansion of our U.S. Ranexa labeling with the potential for a new first line angina indication and new promotable claims for the reduction of hemoglobin A1c (HbA1c) and the reduction of arrhythmias in coronary patients. We also expect to submit a marketing authorization application for regadenoson in Europe later this year.

This extraordinary collection of 2008 milestones follows a year in which the company saw double digit quarter-over-quarter Ranexa revenue growth throughout the year and significantly reduced spending. The mid-year restructuring we completed fundamentally improved the financial foundation of the company, with cash consumption averaging $57 million per quarter in Q1 and Q2 pre-restructuring and averaging $22 million utilized per quarter in Q3 and Q4 post-restructuring. From this strong financial starting point ($179 million in cash, cash equivalents, marketable securities and restricted cash at year end), we are building a business supported by multiple potential revenue streams.

On the clinical side, the watershed event of 2007 was the presentation and publication of data from the MERLIN TIMI-36 trial. The results of this comprehensive outcomes study confirmed the safety of Ranexa in a high risk population and also produced important data showing statistically significant reductions in HbA1c and in ventricular arrhythmias. Based on the results of MERLIN TIMI-36, along with seven other clinical and five preclinical studies on Ranexa, we submitted a supplemental new drug application to the U.S. Food and Drug Administration (FDA) in September 2007. This is not an ordinary filing for a modest label expansion. It is a proposed transformational package insert change based on an approximately 400,000 page submission, almost 70 percent of the size of the original Ranexa new drug application.

Based on the data and our special protocol assessment agreement in place with the FDA, we are optimistic that we can receive first line angina labeling and a significant reduction to the cautionary language in the current labeling. In parallel, the FDA also is reviewing separate filings for promotable claims for the reduction of arrhythmias in coronary artery disease patients and for promotable claims for the reduction of HbA1c in coronary artery disease patients. All of these regulatory applications have a common Prescription Drug User Fee Act action date of July 27, 2008.

CV Therapeutics holds worldwide rights to Ranexa. In Europe, we expect the European Medicines Agency to take action on our marketing authorization application by the middle of 2008. As we move towards potential approval in Europe and potential labeling expansions in the U.S., which could make Ranexa even more suitable for use by primary care physicians, we are actively exploring potential global and territorial collaborations for Ranexa, which could enhance the potential upside of the product.

The potential launch of regadenoson offers another possible revenue stream for CV Therapeutics in 2008 and beyond. In addition to the $12 million FDA approval milestone we could receive from our North American commercial partner, Astellas Pharma US, Inc., we also would receive a royalty from Astellas on regadenoson and a separate smaller royalty on another of their products. We discovered regadenoson at CV Therapeutics and brought it through 10 successful clinical trials to potential approval in less than a decade. Outside of North America, we retain commercial rights to regadenoson and we currently plan to submit a marketing authorization application in Europe by the end of 2008.

It is also important to remember that our pipeline is very robust and includes the development of other potential uses of Ranexa such as the treatment of atrial fibrillation and diastolic heart failure as well as multiple first-in-class compounds to address unmet clinical needs. In addition to tecadenoson for potential treatment of atrial fibrillation and CVT-6883 for potential treatment of asthma and other conditions, which are in clinical development, we have several preclinical programs, including CVT-10,216 for potential treatment of alcohol addiction and CVT-3619 for potential treatment of diabetes, which could enter clinical trials within a year.

We believe that CV Therapeutics is uniquely positioned for future growth. We have seen consistent patient and physician satisfaction with Ranexa despite very restrictive product labeling. More than 26,000 physicians and 11,000 cardiologists have written at least one Ranexa prescription since launch and we continued to add between 200 and 300 new physician prescribers each week in 2007. With the continued data flow from the MERLIN TIMI-36 study expected throughout 2008, a streamlined spending plan and upcoming regulatory milestones that could trigger increases in both product revenue and royalty income, we believe we have positioned the company for a very strong and exciting 12-18 months. We are working to achieve these potential milestones in order to build a much stronger longterm financial foundation.

Despite a challenging stock market environment over the past year, we have made exceptional strides in our business to lay the foundation for longterm success. We believe that if we achieve our milestones in 2008, there are significant opportunities to drive shareholder value and bring important new products to patients in the United States and Europe.

Thank you for your continued support of CV Therapeutics.

Louis G. Lange, M.D., Ph.D.
Chairman of the Board and Chief Executive Officer
March 15, 2008