1008848--3/2/2009--ACORDA_THERAPEUTICS

related topics

{product, candidate, development}

{product, liability, claim}

{property, intellectual, protect}

{stock, price, share}

{stock, price, operating}

{provision, law, control}

{control, financial, internal}

{regulation, government, change}

{customer, product, revenue}

{financial, litigation, operation}

{personnel, key, retain}

{cost, regulation, environmental}

{acquisition, growth, future}

{regulation, change, law}

Risks related to our business We have a history of operating losses and we expect to continue to incur losses and may never be profitable. If we are unable to obtain regulatory approval for Fampridine-SR in the U.S., the European Union, or other markets, or any approval is unduly limited in scope or delayed, our business prospects will be materially adversely affected. We will be substantially dependent on sales of one product, Zanaflex Capsules, to generate revenue for the foreseeable future. We expect to further increase our sales force in anticipation of the possible launch of Fampridine-SR and sales of Zanaflex Capsules may not grow sufficiently, or Fampridine-SR may not get approved, to offset the increased costs associated with this expansion. We will need to obtain regulatory approval in foreign jurisdictions where we seek to market our products. Our product candidates must undergo rigorous clinical testing, the results of which are uncertain and could substantially delay or prevent us from bringing them to market. Our other drug development programs are in early stages of development and may never be commercialized. The pharmaceutical industry is subject to stringent regulation and failure to obtain regulatory approval will prevent commercialization of our product candidates. Our products and product candidates may not gain market acceptance among physicians, patients and the medical community, thereby limiting our potential to generate revenue. Our potential products may not be commercially viable if we fail to obtain an adequate level of reimbursement for these products by Medicaid, Medicare or other third-party payers. If our competitors develop and market products that are more effective, safer or more convenient than our approved products, or obtain marketing approval before we obtain approval of future products, our commercial opportunity will be reduced or eliminated. Our operations could be curtailed if we are unable to obtain any necessary additional financing on favorable terms or at all. Under our financing arrangement with the Paul Royalty Fund, or PRF, upon the occurrence of certain events, PRF may require us to repurchase the right to receive revenues that we assigned to it or may foreclose on the Zanaflex assets that secure our obligations to PRF. Any exercise by PRF of its right to cause us to repurchase the assigned right or any foreclosure by PRF could adversely affect our results of operations and our financial condition. The loss of our key management and scientific personnel may hinder our ability to execute our business plan. We face an inherent risk of liability in the event that the use or misuse of our products results in personal injury or death. We are subject to various federal and state laws regulating the marketing of Zanaflex Capsules and, if we do not comply with these regulations, we could face substantial penalties. We may be subject to penalties if we fail to comply with post-approval legal and regulatory requirements and our products could be subject to restrictions or withdrawal from the market. State pharmaceutical marketing compliance and reporting requirements may expose us to regulatory and legal action by state governments or other government authorities. If we use biological and hazardous materials in a manner that causes injury, we may be liable for damages. Fulfilling our obligations pursuant to compliance with the Sarbanes-Oxley Act of 2002 is expensive and time consuming. Risks related to our dependence on third parties We currently have no manufacturing capabilities and are substantially dependent upon Elan and other third party suppliers to manufacture Zanaflex Capsules, Zanaflex tablets and Fampridine-SR. If third-party contract research organizations do not perform in an acceptable and timely manner, our preclinical testing or clinical trials could be delayed or unsuccessful. Risks related to our intellectual property If we cannot protect, maintain and, if necessary, enforce our intellectual property, our ability to develop and commercialize our products will be severely limited. If third parties successfully claim that we infringed their patents or proprietary rights, our ability to continue to develop and successfully commercialize our product candidates could be delayed. We are dependent on our license agreements and if we fail to meet our obligations under these license agreements, or our agreements are terminated for any reason, we may lose our rights to our in-licensed patents and technologies. Risks relating to our common stock Our stock price may be volatile and you may lose all or a part of your investment. Future sales of our common stock could cause our stock price to decline. If our officers, directors and largest stockholders choose to act together, they may be able to control the outcome of stockholder vote. Certain provisions of Delaware law, our certificate of incorporation and our bylaws may delay or prevent an acquisition of us that stockholders may consider favorable or may prevent efforts by our stockholders to change our directors or our management, which could decrease the value of your shares. Because we do not intend to pay dividends in the foreseeable future, you will benefit from an investment in our common stock only if it appreciates in value.

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1008848--3/2/2009--ACORDA_THERAPEUTICS_INC