1066833--3/30/2007--DOV_PHARMACEUTICAL

related topics

{product, candidate, development}

{stock, price, share}

{property, intellectual, protect}

{product, liability, claim}

{stock, price, operating}

{product, market, service}

{cost, regulation, environmental}

{personnel, key, retain}

{interest, director, officer}

{system, service, information}

{cost, operation, labor}

{control, financial, internal}

{provision, law, control}

Risks Related to our Business If we cannot raise additional funding, we may be unable to complete development of our product candidates. Failure to obtain approval by our shareholders of an increase in our authorized shares of common stock will result in dilution to shareholders as well as a retained liquidation preference to our series c convertible preferred stockholders. Mandatory conversion of our series C convertible preferred stock will result in dilution to our common stockholders and may cause our common stock s price to decline. The delisting of our common stock from The NASDAQ Global Market will result in more limited trading opportunities for holders of our common stock, increased volatility and additional difficulty in raising capital in the future if needed. Our stock price is likely to be volatile and the market price of our common stock may decline. We have incurred losses since our inception and expect to incur significant losses for the foreseeable future, and we may never reach profitability. We are dependent on the successful outcome of clinical trials for our lead product candidates. We may determine to continue to reduce staffing further as a result of stopping certain clinical trials and other development activities for bicifadine, in which case we could face lawsuits. We have experienced a substantial decline in our workforce and we may continue to experience such declines given the uncertainty of our current business situation. Further reductions could hinder our ability to efficiently complete regulatory closeouts of our clinical studies or transact discussions with potential partners. We may not receive regulatory approvals for our product candidates, approvals may be delayed or the approvals we receive may not be sufficient to fulfill our current goals for our product candidates. Our operating results are subject to fluctuations that may cause our stock price to decline. Our success in developing our product candidates depends upon the performance of our licensees and collaborative partners. The independent clinical investigators and contract research organizations that we rely upon to assist in the conduct of our clinical trials may not be diligent, careful or timely, and may make mistakes, in the conduct of our trials. Our existing collaborative and licensing agreements contain, and any such agreements that we may enter into in the future may contain, covenants that restrict our product development and commercialization activities. If we are unable to create sales, marketing and distribution capabilities, or enter into agreements with third parties to perform these functions, we will not be able to commercialize our product candidates. The success of our business depends upon the members of our senior management team, our scientific staff and our ability to continue to attract and retain qualified scientific, technical and business personnel. We may be subject to claims that we or our employees have wrongfully used or disclosed alleged trade secrets of their former employers. Because some of our product candidates are protected by patents with respect to some of our product candidates that have expired or will expire in the near term, we may be required to rely solely on the Hatch-Waxman Act for market exclusivity. Our business activities require compliance with environmental laws, which if violated could result in significant fines and work stoppage. We have not been able to fully utilize our new corporate headquarters, and as a result, our overhead expenses have increased. Our bylaws require us to indemnify our officers and directors to the fullest extent permitted by law, which may obligate us to make substantial payments and in some instances payments in advance of judicial resolution of entitlement. Provisions of Delaware law, our charter and by-laws and our stockholders rights plan may make a takeover more difficult. Risks Related to our Industry We face intense competition and if we are unable to compete effectively, the demand for our products, if any, may be reduced. If we are unable to protect our intellectual property, our competitors could develop and market products based on our discoveries, which may reduce demand for our product candidates. The intellectual property of our competitors or other third parties may prevent us from developing or commercializing our product candidates. Our ability to receive royalties and profits from product sales depends in part upon the availability of approved reimbursement for the use of our products from third-party payors, for which we may or may not qualify. We face potential product liability exposure, and if successful claims are brought against us, we may incur substantial liability for a product and may have to limit its commercialization.

Full 10-K form ▸

1066833--3/30/2007--DOV_PHARMACEUTICAL_INC