1083132--3/15/2006--IMMUNICON

related topics

{product, candidate, development}

{property, intellectual, protect}

{stock, price, share}

{product, liability, claim}

{stock, price, operating}

{provision, law, control}

{control, financial, internal}

{personnel, key, retain}

{customer, product, revenue}

{cost, regulation, environmental}

{system, service, information}

RISKS RELATING TO OUR BUSINESS We have a history of operating losses, expect to continue to incur substantial losses, and might never achieve or maintain profitability. If our relationship with Veridex is terminated or does not function effectively, we may be unable to continue to commercialize effectively certain of our products based on our technologies in the field of cancer. If our products and Veridex s products do not achieve market acceptance, we will be unable to generate significant revenues from them. If we or Veridex are not able to obtain all of the regulatory approvals and clearances required to commercialize our products, our business would be significantly harmed. If the third-party manufacturers we rely on either refuse or are unable to successfully manufacture certain of our products, we may be unable to commercialize these products. If third-party payors do not reimburse customers for our products and Veridex s products, they might not be used or purchased, which would adversely affect our revenues. If we or any of our third-party manufacturers do not maintain high standards of manufacturing in accordance with Quality System Regulations, our ability to develop, and Veridex s and our ability to commercialize our products, could be delayed or curtailed. If we fail to obtain necessary funds for our operations, we will be unable to continue to develop and commercialize new products and technologies. If the third parties with which we intend to contract with for clinical trials do not perform in an acceptable manner, or if we suffer setbacks in these clinical trials, our business may suffer. If we lose key management or scientific personnel, scientific collaborators or other advisors, our business would suffer. If Veridex and the other third-parties on which we currently rely or may rely in the future to perform marketing, sales and distribution services for our products do not successfully perform these services, our business will be harmed. If the limited number of suppliers on which we rely fail to supply the raw materials we use in the manufacturing of our reagent products, we might be unable to satisfy product demand, which would negatively impact our business. If our competitors develop and market technologies or research and diagnostic products faster than we or Veridex do or if those products are more effective than our products, our commercial opportunities will be reduced or eliminated. If we experience delays in the development of new products or delays in planned improvements to our products, our commercial opportunities will be reduced. If product liability lawsuits are successfully brought against us, we might incur substantial liabilities and could be required to limit the commercialization of our products. If we use biological and hazardous materials in a manner that causes injury, we could be liable for damages. If we are unable to manage growth in connection with our transition from an early-stage development company to a company that commercializes research and diagnostic products, our operations will suffer. RISKS RELATED TO OUR INTELLECTUAL PROPERTY If we are unable to protect our proprietary rights, we may not be able to compete effectively. If the use of our technologies conflicts with the intellectual property rights of third-parties, we may incur substantial liabilities and we may be unable to commercialize products based on these technologies in a profitable manner, if at all. Our rights to use technologies licensed to us by third parties are not within our control, and we may not be able to implement our products without these technologies. If we cannot obtain additional licenses to intellectual property owned by third parties that we desire to incorporate into new products we plan to develop, we may not be able to develop or commercialize these future products. RISKS RELATING TO OUR COMMON STOCK The market price of our common stock may be highly volatile. The future sale of our common stock and the exercise of outstanding options and warrants could negatively affect our stock price and cause dilution. If the price and volume of our common stock experience fluctuations, this could lead to costly litigation for us. Anti-takeover provisions in our certificate of incorporation and bylaws and under Delaware law could inhibit a change in control or a change in management that holders of our common stock consider favorable. We do not expect to pay dividends in the foreseeable future. As a result, holders of our common stock must rely on stock appreciation for any return on their investment.

Full 10-K form ▸

1083132--3/15/2006--IMMUNICON_CORP