1070494--3/9/2007--ACADIA_PHARMACEUTICALS

related topics

{product, candidate, development}

{property, intellectual, protect}

{stock, price, operating}

{product, liability, claim}

{cost, operation, labor}

{stock, price, share}

{provision, law, control}

{gas, price, oil}

{control, financial, internal}

{regulation, change, law}

{cost, regulation, environmental}

{personnel, key, retain}

{operation, international, foreign}

{investment, property, distribution}

Risks Related to Our Business We expect our net losses to continue for at least several years and are unable to predict the extent of future losses or when we will become profitable, if ever. Our most advanced drug candidates are in clinical trials, which are long, expensive and unpredictable, and there is a high risk of failure. Delays, suspensions and terminations in our clinical trials could result in increased costs to us and delay our ability to generate product revenues. If we fail to obtain the capital necessary to fund our operations, we will be unable to successfully develop products. We depend on collaborations with third parties to develop and commercialize selected drug candidates and to provide substantially all of our revenues. If conflicts arise with our collaborators, they may act in their self interests, which may be adverse to our interests. We rely on third parties to conduct our clinical trials and perform data collection and analysis, which may result in costs and delays that prevent us from successfully commercializing drug candidates. Even if we or our collaborators successfully complete the clinical trials of drug candidates, the drug candidates may fail for other reasons. Our drug candidates may not gain acceptance among physicians, patients, and the medical community, thereby limiting our potential to generate revenues. We do not know whether one of our drug candidates, ACP-104, will have the same adverse effects as clozapine, a currently available therapy. If we are unable to attract, retain, and motivate key management and scientific staff, our drug development programs and our research and discovery efforts may be delayed and we may be unable to successfully develop or commercialize our drug candidates. We do not know whether our drug discovery platform will lead to the discovery or development of commercially viable drug candidates. We may not be able to continue or fully exploit our collaborations with outside scientific and clinical advisors, which could impair the progress of our clinical trials and our research and development efforts. We will need to increase the size of our organization, and we may encounter difficulties managing our growth, which could adversely affect our results of operations. We face financial and administrative challenges in coordinating the operations of our European activities with our activities in California, which could have an adverse impact on our operations. We expect that our results of operations will fluctuate, which may make it difficult to predict our future performance from period to period. Relying on third-party manufacturers may result in delays in our clinical trials and product introductions. Our management has broad discretion over the use of our cash and we may not use our cash effectively, which could adversely affect our results of operations. We have incurred, and expect to continue to incur, significant costs as a result of recently enacted and proposed changes in laws and regulations relating to corporate governance and other matters. If we are unable to establish sales and marketing capabilities or enter into agreements with third parties to sell and market any products we may develop, we may not be able to generate product revenue. If we engage in any acquisition, we will incur a variety of costs and may never realize the anticipated benefits of the acquisition. Earthquake damage to our facilities could delay our research and development efforts and adversely affect our business. Risks Related to Our Intellectual Property Our ability to compete may decline if we do not adequately protect our proprietary rights. We have limited proprietary rights to one of our drug candidates, ACP-104, which may limit our ability to prevent competitors from exploiting that compound. Confidentiality agreements with employees and others may not adequately prevent disclosure of our trade secrets and other proprietary information and may not adequately protect our intellectual property, which could limit our ability to compete. A dispute concerning the infringement or misappropriation of our proprietary rights or the proprietary rights of others could be time consuming and costly, and an unfavorable outcome could harm our business. The patent applications of pharmaceutical and biotechnology companies involve highly complex legal and factual questions, which, if determined adversely to us, could negatively impact our patent position. Risks Related to Our Industry We will be subject to stringent regulation in connection with the marketing of any products derived from our drug candidates, which could delay the development and commercialization of our products. If our competitors develop and market products that are more effective than our drug candidates, they may reduce or eliminate our commercial opportunity. Any claims relating to improper handling, storage, or disposal of biological, hazardous, and radioactive materials used in our business could be costly and delay our research and development efforts. Consumers may sue us for product liability, which could result in substantial liabilities that exceed our available resources and damage our reputation. Risks Related to Our Common Stock Our stock price may be particularly volatile because we are a drug discovery and development company. If our officers, directors, and largest stockholders choose to act together, they may be able to significantly influence our management and operations, acting in their best interests and not necessarily those of our other stockholders. If we or our stockholders sell substantial amounts of our common stock, the market price of our common stock may decline. Anti-takeover provisions in our charter documents and under Delaware law may make an acquisition of us more complicated and may make the removal and replacement of our directors and management more difficult.

Full 10-K form ▸

1070494--3/9/2007--ACADIA_PHARMACEUTICALS_INC