921506--2/28/2008--CV_THERAPEUTICS

related topics

{product, candidate, development}

{product, liability, claim}

{stock, price, share}

{control, financial, internal}

{stock, price, operating}

{personnel, key, retain}

{debt, indebtedness, cash}

{property, intellectual, protect}

{provision, law, control}

{operation, international, foreign}

{loss, insurance, financial}

{regulation, change, law}

{cost, regulation, environmental}

{acquisition, growth, future}

{competitive, industry, competition}

Risk Factors Relating to Our Business We expect to continue to operate at a loss, we may not be able to maintain our current levels of research, development and commercialization activities, and we may never achieve profitability. Our operating results are subject to fluctuations that may cause our stock price to decline. We will need substantial additional capital in the future. If we are unable to secure additional financing, we may be unable to continue to commercialize our products or continue our research and development activities or continue any of our other operations at current levels, or we may need to limit, scale back or cease our operations. The success of our company is largely dependent on the success of Ranexa. While we have negotiated a special protocol assessment agreement with the FDA relating to the MERLIN TIMI-36 clinical study of Ranexa, this agreement relates to the chronic angina indication for the product, and does not guarantee any particular regulatory outcome from regulatory review of the study or the product, including any changes to product labeling or approvals. Ranexa may not achieve market acceptance or generate revenues. The commercialization of our products is substantially dependent on our ability to develop effective sales and marketing capabilities. Even after a product has been approved for commercial sale, if we or others identify previously known or unknown side effects or manufacturing problems occur, approval could be withdrawn or sales of the product could be significantly reduced. We may be subject to product liability claims and we have only limited product liability insurance. If we are unable to compete successfully in our market, it will harm our business. Failure to obtain adequate reimbursement from government health administration authorities, private health insurers and other organizations could materially adversely affect our future business, market acceptance of our products, results of operations and financial condition. Guidelines and recommendations published by various organizations may affect the use of our products. We may be required to defend lawsuits or pay damages in connection with the alleged or actual violation of healthcare statutes such as fraud and abuse laws, and our corporate compliance programs can never guarantee that we are in compliance with all relevant laws and regulations. The successful commercialization of our products, including regadenoson if it is approved for marketing in the United States, is substantially dependent on the successful and timely performance of our strategic collaborative partners and other vendors, over whom we have little or no control. We have no manufacturing facilities and depend on third parties to manufacture and distribute Ranexa, and to manufacture our product candidates. All of our products in development require regulatory review and approval prior to commercialization. Any delay in the regulatory review or approval of any of our product candidates will harm our business. The successful development of drug products is highly uncertain and requires significant expenditures and time. Any delay in the development of any of our drug product candidates will harm our business. We rely on a large number of clinical research organizations and foreign clinical sites to conduct our clinical trials, including the MERLIN TIMI-36 clinical trial of Ranexa and the Phase 3 studies of regadenoson, which may adversely affect our ability to complete our clinical trials on a timely basis, or the outcome of our clinical trials or of regulatory inspections. If we are unable to satisfy governmental regulations relating to the development and commercialization of our drug candidates, we may be subject to significant FDA sanctions. If we are unable to attract, retain or avoid disputes with collaborators, licensors and licensees, the development of our products could be delayed and our future capital requirements could increase substantially. If we are unable to effectively protect our intellectual property, we may be unable to complete development of any products and we may be put at a competitive disadvantage; and, if we are involved in an intellectual property rights dispute, we may not prevail and may be subject to significant liabilities or required to license rights from a third party, or cease one or more product programs. Our business depends on certain key personnel, the loss of whom could weaken our management team, and on attracting and retaining qualified personnel. Our operations involve hazardous materials, which could subject us to significant liability. We are exposed to risks related to foreign currency exchange rates. Our insurance policies are expensive and protect us only from some business risks, which will leave us exposed to significant, uninsured liabilities. Risk Factors Relating to Our Common Stock and Convertible Debt Investor confidence and share value may be adversely impacted if our independent auditors provide to us an adverse opinion or a disclaimer of opinion regarding the effectiveness of our internal control over financial reporting under Section 404 of the Sarbanes-Oxley Act of 2002. The market price of our stock has been and may continue to be highly volatile, and the value of an investment in our common stock may decline. Our indebtedness and debt service obligations may adversely affect our financial position. If we sell shares of our common stock under our equity line of credit arrangement or in other future financings, existing common stockholders will experience immediate dilution and, as a result, our stock price may go down. Provisions of Delaware law and in our charter, by-laws and our rights plan may prevent or frustrate any attempt by our stockholders to replace or remove our current management and may make the acquisition of our company by another company more difficult. If any or all of our existing notes and debentures are converted into shares of our common stock, existing common stockholders will experience immediate dilution and, as a result, our stock price may go down.

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921506--2/28/2008--CV_THERAPEUTICS_INC