891288--3/16/2010--QUESTCOR_PHARMACEUTICALS_INC

related topics
{product, candidate, development}
{regulation, government, change}
{acquisition, growth, future}
{operation, natural, condition}
{competitive, industry, competition}
{product, liability, claim}
{tax, income, asset}
{condition, economic, financial}
{property, intellectual, protect}
{control, financial, internal}
{personnel, key, retain}
{cost, regulation, environmental}
{system, service, information}
We cannot predict whether the FDA will approve our sNDA for Acthar. We are aware of several competitors attempting to develop and market products competitive to Acthar, which may reduce or eliminate our commercial opportunity. Our strategy to generate Acthar revenue from other therapeutic areas might not be successful. The manufacture of our products is a highly exacting and complex process, and if any of our suppliers encounters problems manufacturing products, our business could suffer. Risks Associated with Our non-Acthar Growth Initiatives We have a very limited pipeline of new products. Our strategy to diversify our product portfolio might not be successful. We may have insufficient capital to fund our Growth Initiatives and may be forced to seek dilutive financing. Risks Associated with Government Regulations and Health Care Reform Federal and/or state health care reform initiatives could negatively affect our business. Questcor operates in a highly regulated industry. We may be negatively affected by lower reimbursement levels. Medicaid eligible patients and government entities may account for a greater proportion of our Acthar unit sales resulting in reduced net sales. We may be negatively affected by unforeseen invoicing of historical Medicaid sales. We are currently subject to numerous governmental regulations and it can be costly to comply with these regulations and to develop compliant products and processes. Other Risks Associated with our Business The loss of our key management personnel or failure to integrate new management personnel could have an adverse impact on future operations. Our financial results can be negatively impacted by economic downturns. If we are unable to protect our proprietary rights, we may lose our competitive position and future revenues. If we fail to maintain an effective system of internal controls, we may not be able to accurately report our financial results. As a result, current and potential shareholders could lose confidence in our financial reporting, which could have a negative market reaction. If product liability lawsuits are successfully brought against us or we become subject to other forms of litigation, we may incur substantial liabilities and costs and may be required to limit commercialization of our products. Business interruptions could limit our ability to operate our business.

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