1107332--3/12/2009--DENDREON

related topics

{product, candidate, development}

{stock, price, share}

{product, liability, claim}

{property, intellectual, protect}

{cost, regulation, environmental}

{regulation, government, change}

{acquisition, growth, future}

{debt, indebtedness, cash}

{control, financial, internal}

{provision, law, control}

{financial, litigation, operation}

{operation, international, foreign}

If testing of a particular product candidate does not yield successful results, then we will be unable to commercialize that product. The FDA or its Advisory Committee may determine our clinical trials data regarding safety or efficacy are insufficient for regulatory approval. We must expand our operations to commercialize Provenge, and we may encounter unexpected costs or difficulties. We may take longer to complete our clinical trials than we project, or we may not be able to complete them at all. If we encounter difficulties enrolling patients in our clinical trials, our trials could be delayed or otherwise adversely affected. Risks Relating to our Financial Position and Need for Additional Financing We have a history of operating losses. We expect to continue to incur losses for the near future, and we may never become profitable. We are likely to require additional funding, and our future access to capital is uncertain. Our substantial indebtedness could adversely affect our financial condition. Our stockholders may be diluted by the conversion of our outstanding convertible notes. We may elect to issue additional shares of our common stock or other securities that may be convertible into our common stock, which could result in further dilution to our existing stockholders. Risks Related to Regulation of our Industry The industry within which we operate and our business is subject to extensive regulation, which is costly, time consuming and may subject us to unanticipated delays. Commercialization of our product candidates in the United States requires FDA approval, which may not be granted, and foreign commercialization requires similar approvals. Failure to comply with foreign regulatory requirements governing human clinical trials and marketing approval for product candidates could prevent us from selling our products in foreign markets, which may adversely affect our operating results and financial condition. Even if approved, Provenge and any other product we may commercialize and market may be later withdrawn from the market or subject to promotional limitations. The availability and amount of reimbursement for our product candidates and the manner in which government and private payers may reimburse for our potential products is uncertain. The pharmaceutical industry is subject to significant regulation and oversight in the United States. Multi-jurisdictional regulations, including those establishing our ability to price products, may negatively affect our sales and profit margins. Risks Relating to Manufacturing Activities We have limited commercial or other large-scale manufacturing experience. We and our contract manufacturers are subject to significant regulation with respect to manufacturing of our products. We must rely at present on relationships with third-party contract manufacturers, which will limit our ability to control the availability of, and manufacturing costs for, our product candidates in the near-term. We rely on single source vendors for some key components for our active immunotherapy candidates, which could impair our supply of such product. We use hazardous materials in our business and must comply with environmental laws and regulations, which can be expensive. Our competitors may develop and market products that are less expensive, more effective, safer or reach the market sooner, which may diminish or eliminate the commercial success of any products we may commercialize. Our products may not be accepted in the marketplace; therefore, we may not be able to generate significant revenue, if any. Failure to retain key personnel could impede our ability to develop our products and to obtain new collaborations or other sources of funding. Risks Relating to Collaboration Arrangements If we fail to enter into any needed collaboration agreements for our product candidates, we may be unable to commercialize them effectively or at all. Risks in Protecting our Intellectual Property If we are unable to protect our proprietary rights or to defend against infringement claims, we may not be able to compete effectively or operate profitably. We may be subject to litigation with respect to the ownership and use of intellectual property that will be costly to defend or pursue and uncertain in its outcome. We are exposed to potential product liability claims, and insurance against these claims may not be available to us at a reasonable rate in the future. Risks Relating to an Investment in Our Common Stock We are currently subject to certain pending litigation and a stockholder demand and may be subject to similar claims in the future. Market volatility may affect our stock price, and the value of an investment in our common stock may be subject to sudden decreases. Anti-takeover provisions in our charter documents and under Delaware law and our stockholders rights plan could make an acquisition of us, which may be beneficial to our stockholders, more difficult.

Full 10-K form ▸

1107332--3/12/2009--DENDREON_CORP