1020214--3/11/2010--CERUS

related topics

{product, candidate, development}

{system, service, information}

{control, financial, internal}

{loan, real, estate}

{product, liability, claim}

{stock, price, share}

{property, intellectual, protect}

{provision, law, control}

{operation, international, foreign}

{acquisition, growth, future}

{cost, operation, labor}

{customer, product, revenue}

{stock, price, operating}

The INTERCEPT Blood System may not achieve broad market acceptance. Our products, blood products treated with the INTERCEPT Blood System and we are subject to extensive regulation by domestic and foreign authorities. If our preclinical and clinical data are not considered sufficient by regulatory authorities to grant marketing approval, we will be unable to commercialize our products and generate revenue. Our red blood cell system requires extensive additional testing and development. We have limited experience operating a commercial organization. We rely on third parties to market, sell, and distribute our products and to maintain customer relationships in a certain countries. Our product design and manufacturing supply chain is highly technical and exposes us to significant risks The platelet system is not compatible with some commercial platelet collection methods and platforms and platelet storage solutions. We have used prototype components in our preclinical studies and clinical trials of the INTERCEPT red blood cell system and have not completed the components commercial design. We will be required to identify and enter into agreements with third parties to manufacture the red blood cell system and related blood component storage solutions. BioOne may fail to take advantage of commercialization rights for our platelet and plasma systems in many Asian countries. If our competitors develop and market products that are more effective than our products and product candidates, our commercial opportunity will be reduced or eliminated. We may be liable and we may need to withdraw our products from the market if our products harm people. We may be liable if an accident occurs in our controlled use of hazardous materials. Our insurance coverage may be inadequate to offset losses we may incur. If we fail to obtain the capital necessary to fund our future operations or if we are unable to generate positive cash flows from our operations, we will need to curtail planned development or sales and commercialization activities. We have only a limited operating history, and we expect to continue to generate losses. Our investment portfolio may become impaired by further deterioration of the capital markets. Virtually all of our research and development activities and the significant majority of our general and administrative activities are performed in or managed from a single site that may be subject to lengthy business interruption in the event of a severe earthquake. We also may suffer loss of computerized information and may be unable to make timely filings with regulatory agencies in the event of catastrophic failure of our data storage and backup systems. We do not anticipate receiving significant economic benefit from the spin-off of our immunotherapy business. We may not be able to protect our intellectual property or operate our business without infringing intellectual property rights of others. As our international operations grow, we may be subject to adverse fluctuations in exchange rates between the United States dollar and foreign currencies. Consequently, we may suffer losses. The market price of our stock may be highly volatile. Our stock price may not meet the minimum bid price for continued listing on The NASDAQ Global Market. Our ability to publicly or privately sell equity securities and the liquidity of our common stock could be adversely affected if we are delisted from The NASDAQ Global Market or if we are unable to transfer our listing to another stock market. We may fail to comply fully with elements of the Sarbanes-Oxley Act of 2002. Our failure to maintain effective internal controls in accordance with Section 404 of this Act could have a material adverse effect on our stock price. Provisions of our charter documents, our stockholder rights plan and Delaware law could make it more difficult for a third party to acquire us, even if the offer may be considered beneficial by our stockholders.

Full 10-K form ▸

1020214--3/11/2010--CERUS_CORP