1178879--2/8/2008--AMICUS_THERAPEUTICS

related topics

{product, candidate, development}

{product, liability, claim}

{property, intellectual, protect}

{stock, price, share}

{stock, price, operating}

{cost, regulation, environmental}

{provision, law, control}

{cost, operation, labor}

{control, financial, internal}

{acquisition, growth, future}

{personnel, key, retain}

{regulation, change, law}

Any capital that we obtain may not be on terms favorable to us or our stockholders or may require us to relinquish valuable rights. Our short operating history may make it difficult to evaluate the success of our business to date and to assess our future viability. Risks Related to the Development and Commercialization of Our Product Candidates We depend heavily on the success of our most advanced product candidates, Amigal, Plicera and AT2220. All of our product candidates are still in either preclinical or clinical development. Clinical trials of our product candidates may not be successful. If we are unable to commercialize Amigal, Plicera or AT2220, or experience significant delays in doing so, our business will be materially harmed. If the market opportunities for our product candidates are smaller than we believe they are, then our revenues may be adversely affected and our business may suffer. Initial results from a clinical trial do not ensure that the trial will be successful and success in early stage clinical trials does not ensure success in later-stage clinical trials. We have limited experience in conducting and managing the preclinical development activities and clinical trials necessary to obtain regulatory approvals, including approval by the FDA. We may find it difficult to enroll patients in our clinical trials. If our preclinical studies do not produce positive results, if our clinical trials are delayed or if serious side effects are identified during drug development, we may experience delays, incur additional costs and ultimately be unable to commercialize our product candidates. The commercial success of any product candidates that we may develop, including Amigal, Plicera and AT2220, will depend upon the degree of market acceptance by physicians, patients, third party payors and others in the medical community. If we are unable to obtain adequate reimbursement from governments or third party payors for any products that we may develop or if we are unable to obtain acceptable prices for those products, our prospects for generating revenue and achieving profitability will suffer. Governments outside the U.S. tend to impose strict price controls and reimbursement approval policies, which may adversely affect our prospects for generating revenue. If we are unable to establish sales and marketing capabilities or enter into agreements with third parties to market and sell our product candidates, we may be unable to generate product revenue. Product liability lawsuits against us could cause us to incur substantial liabilities and to limit commercialization of any products that we may develop. We face substantial competition which may result in others discovering, developing or commercializing products before or more successfully than we do. Our business activities involve the use of hazardous materials, which require compliance with environmental and occupational safety laws regulating the use of such materials. If we violate these laws, we could be subject to significant fines, liabilities or other adverse consequences. Risks Related to Our Dependence on Third Parties Use of third parties to manufacture our product candidates may increase the risk that we will not have sufficient quantities of our product candidates or such quantities at an acceptable cost, and clinical development and commercialization of our product candidates could be delayed, prevented or impaired. Materials necessary to manufacture our product candidates may not be available on commercially reasonable terms, or at all, which may delay the development and commercialization of our product candidates. We rely on third parties to conduct certain preclinical development activities and our clinical trials and those third parties may not perform satisfactorily, including failing to meet established deadlines for the completion of such activities and trials. We may not be successful in maintaining or establishing collaborations, which could adversely affect our ability to develop and, particularly in international markets, commercialize products. Our collaboration with Shire Pharmaceuticals Ireland Ltd. (Shire) is important to our business. If this collaboration is unsuccessful or if Shire terminates this collaboration or its participation in individual programs, our business could be adversely affected. Risks Related to Our Intellectual Property If we are unable to obtain and maintain protection for the intellectual property relating to our technology and products, the value of our technology and products will be adversely affected. If we fail to comply with our obligations in our intellectual property licenses with third parties, we could lose license rights that are important to our business. If we are unable to protect the confidentiality of our proprietary information and know-how, the value of our technology and products could be adversely affected. If we infringe or are alleged to infringe the intellectual property rights of third parties, it will adversely affect our business. Risks Related to Regulatory Approval of Our Product Candidates If we are not able to obtain and maintain required regulatory approvals, we will not be able to commercialize our product candidates, and our ability to generate revenue will be materially impaired. Our product candidates may cause undesirable side effects or have other properties that could delay or prevent their regulatory approval or commercialization. We may not be able to obtain orphan drug exclusivity for our product candidates. If our competitors are able to obtain orphan drug exclusivity for their products that are the same drug as our product candidates, we may not be able to have competing products approved by the applicable regulatory authority for a significant period of time. Any product for which we obtain marketing approval could be subject to restrictions or withdrawal from the market and we may be subject to penalties if we fail to comply with regulatory requirements or if we experience unanticipated problems with our products, when and if any of them are approved. Failure to obtain regulatory approval in international jurisdictions would prevent us from marketing our products abroad. Risks Related to Employee Matters and Managing Growth Our future success depends on our ability to retain our Chief Executive Officer and other key executives and to attract, retain and motivate qualified personnel. We expect to expand our development, regulatory and sales and marketing capabilities, and as a result, we may encounter difficulties in managing our growth, which could disrupt our operations. Risks Related to Our Common Stock Our executive officers, directors and principal stockholders maintain the ability to control all matters submitted to our stockholders for approval. Provisions in our corporate charter documents and under Delaware law could make an acquisition of us, which may be beneficial to our stockholders, more difficult and may prevent attempts by our stockholders to replace or remove our current management. An active trading market for our common stock may not develop. If the price of our common stock is volatile, purchasers of our common stock could incur substantial losses. If securities or industry analysts do not publish research or reports or publish unfavorable research about our business, the price of our common stock and trading volume could decline. We will incur increased costs as a result of being a public company.

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1178879--2/8/2008--AMICUS_THERAPEUTICS_INC