914475--2/4/2009--NEUROCRINE_BIOSCIENCES

related topics

{product, candidate, development}

{product, liability, claim}

{stock, price, operating}

{stock, price, share}

{condition, economic, financial}

{product, market, service}

{regulation, change, law}

{personnel, key, retain}

{cost, operation, labor}

{property, intellectual, protect}

{control, financial, internal}

Our clinical trials may fail to demonstrate the safety and efficacy of our product candidates, which could prevent or significantly delay their regulatory approval. If we cannot raise additional funding, we may be unable to complete development of our product candidates. Our restructuring activities could result in management distractions, operational disruptions and other difficulties. There is uncertainty regarding future development of our product candidate, indiplon, and we may not be able to meet the requirements to receive regulatory approvals for it. We have a history of losses and expect to incur losses and negative operating cash flows for the near future, and we may never achieve sustained profitability. Because our operating results may vary significantly in future periods, our stock price may decline. We license some of our core technologies and drug candidates from third parties. If we default on any of our obligations under those licenses, we could lose our rights to those technologies and drug candidates. Because the development of our product candidates is subject to a substantial degree of technological uncertainty, we may not succeed in developing any of our product candidates. We have limited marketing experience, sales force or distribution capabilities, and if our products are approved, we may not be able to commercialize them successfully. The independent clinical investigators and contract research organizations that we rely upon to conduct our clinical trials may not be diligent, careful or timely, and may make mistakes, in the conduct of our trials. We have no manufacturing capabilities. If third-party manufacturers of our product candidates fail to devote sufficient time and resources to our concerns, or if their performance is substandard, our clinical trials and product introductions may be delayed and our costs may rise. If we are unable to retain and recruit qualified scientists or if any of our key senior executives discontinues his or her employment with us, it may delay our development efforts. We may be subject to claims that we or our employees have wrongfully used or disclosed alleged trade secrets of their former employers. Governmental and third-party payors may impose sales and pharmaceutical pricing controls on our products that could limit our product revenues and delay profitability. If physicians and patients do not accept our products, we may not recover our investment. Compliance with changing regulation of corporate governance and public disclosure may result in additional expenses. The price of our common stock is volatile. Negative conditions in the global credit markets may impair the liquidity of a portion of our investment portfolio. Risks Related to Our Industry We may not receive regulatory approvals for our product candidates or approvals may be delayed. 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 products.

Full 10-K form ▸

914475--2/4/2009--NEUROCRINE_BIOSCIENCES_INC