1037760--2/29/2008--CEPHEID

related topics

{product, candidate, development}

{property, intellectual, protect}

{product, liability, claim}

{customer, product, revenue}

{regulation, government, change}

{product, market, service}

{stock, price, operating}

{cost, regulation, environmental}

{personnel, key, retain}

{operation, international, foreign}

{acquisition, growth, future}

The regulatory approval process is expensive, time-consuming, and uncertain and may prevent us from obtaining required approvals for the commercialization of some of our products. The U.S. Food and Drug Administration has issued a final interpretation of the regulations governing the sale of Analyte Specific Reagent products which could prevent or delay our sales of these products and harm our business. We rely on licenses of key technology from third parties and may require additional licenses for many of our new product candidates. We enter into collaborations with third parties that may not result in the development of commercially viable products or the generation of significant future revenues. Our participation in the USPS BDS program may not result in predictable contracts or revenues in the future. We may face risks associated with acquisitions of companies, products and technologies, and our business could be harmed if we are unable to address these risks. We expect that our operating results will fluctuate significantly, and any failure to meet financial expectations may result in a decline in our stock price. If we are unable to manufacture our products in sufficient quantities and in a timely manner, our operating results will be harmed and our ability to generate revenue could be diminished. If certain single source suppliers fail to deliver key product components in a timely manner, our manufacturing ability would be impaired and our product sales could suffer. If certain of our products fail to obtain an adequate level of reimbursement from third-party payers, our ability to sell products in the Clinical Molecular Diagnostic market would be harmed. If our competitors and potential competitors develop superior products and technologies, our competitive position and results of operations would suffer. If our products do not perform as expected or the reliability of the technology on which our products are based is questioned, we could experience lost revenue, delayed or reduced market acceptance of our products, increased costs and damage to our reputation. If product liability lawsuits are successfully brought against us, we may face reduced demand for our product and incur significant liabilities. We rely on relationships with collaborative partners and other third parties for development, supply and marketing of certain products and potential products, and such collaborative partners or other third parties could fail to perform sufficiently. If our direct selling efforts for our products fail, our business expansion plans could suffer, and our ability to generate revenue will be diminished. If our distributor relationships are not successful, our ability to market and sell our products would be harmed and our financial performance will be adversely affected. We may be subject to third-party claims that require additional licenses for our products and we could face costly litigation, which could cause us to pay substantial damages and limit our ability to sell some or all of our products. If we fail to maintain and protect our intellectual property rights, our competitors could use our technology to develop competing products and our business will suffer. The United States Government has certain rights to use and disclose some of the intellectual property that we license and could exclusively license it to a third party if we fail to achieve practical application of the intellectual property. We may need to initiate lawsuits to protect or enforce our patents, which would be expensive and, if we lose, may cause us to lose some, if not all, of our intellectual property rights, and thereby impair our ability to compete. Our sales cycle can be lengthy, which can cause variability and unpredictability in our operating results. Our international operations subject us to additional risks and costs. The nature of some of our products may also subject us to export control regulation by the US Department of State and the Department of Commerce. Violations of these regulations can result in monetary penalties and denial of export privileges. If we fail to retain key members of our staff, our ability to conduct and expand our business would be impaired. If we become subject to claims relating to improper handling, storage or disposal of hazardous materials, we could incur significant cost and time to comply. If a catastrophe strikes our manufacturing facilities, we may be unable to manufacture our products for a substantial amount of time and we would experience lost revenue.

Full 10-K form ▸