765258--2/29/2008--IMCLONE_SYSTEMS

related topics

{product, candidate, development}

{product, liability, claim}

{stock, price, operating}

{property, intellectual, protect}

{provision, law, control}

{financial, litigation, operation}

{cost, regulation, environmental}

{tax, income, asset}

{personnel, key, retain}

{product, market, service}

{operation, international, foreign}

{stock, price, share}

Risks Relating to Our Business and Other Matters Royalty and manufacturing revenue from sales of ERBITUX represent a substantial portion of our revenues. If ERBITUX does not receive continued market acceptance, sales may not continue and we may not earn sufficient revenues. We depend on BMS and Merck KGaA to co-promote market and sell ERBITUX. If either BMS or Merck KGaA becomes unable to meet its obligations, or we fail to adequately maintain our relationship with these partners, it would negatively impact our revenues and harm our business. We operate in a highly competitive industry, including in terms of product pricing, that is subject to rapid and significant technological change. We are subject to extensive governmental regulation. If we are unable to obtain or maintain regulatory approvals for our product or product candidates, we will not be able to market our product or further develop our product candidates. Our revenues will diminish if our collaborators fail to obtain acceptable prices or adequate reimbursement for ERBITUX from third-party payors. Our royalty and collaborative agreement reimbursement revenues could vary significantly and may adversely impact our business. We will be required to expend significant resources for research and development of our products in development and these products may not be developed successfully, which would adversely affect our prospects for future revenue growth and our stock price. If third parties on which we rely for clinical trials do not perform as contractually required or as we expect, we may not be able to obtain regulatory approval for additional indications for ERBITUX or obtain regulatory approval for or commercialize our product candidates. Difficulties or delays in product manufacturing and finishing could cause shortfalls in the supply of ERBITUX or our product candidates currently being developed which would harm our business and, in the case of ERBITUX, our ability to meet our financial obligations. Our marketing partners may experience pressure to lower the price of ERBITUX because of new and/or proposed federal legislation, which would reduce our royalty revenue and may harm our business. If we become subject to importation of products from Canada and other countries, it will affect our profitability and harm our business. We depend on key employees in a competitive market for skilled personnel, and the loss of the services of any of our key employees would affect our ability to develop our business. The law or FDA policy could change and expose us to competition from "generic" or "follow-on" versions of our products, which may impact our market share and harm our business. Our investment portfolio contains auction rate securities (ARS) which have recently failed at auction and have unrealized losses. These investments could be subject to further unrealized losses and impairment losses if credit and capital markets continue to deteriorate. Risks Relating to Intellectual Property and Legal Matters Protecting our proprietary rights is difficult and costly. If we fail to adequately protect or enforce our proprietary rights, we could lose revenue. Several lawsuits have been filed against us which may be costly to defend and the outcome of which are uncertain and may harm our business. Our operations use hazardous materials, which may lead to environmental liability, and may harm our business. We could be exposed to material product liability claims that could prevent or interfere with the commercialization of any other products that we may develop. Insurance coverage is increasingly more difficult and costly to obtain and maintain. Risks Relating to our Common Stock and Related Matters Certain provisions of Delaware law, our charter and bylaws and our stockholder rights plan could hinder, delay or prevent changes in control. The recent changes in the composition of our Board of Directors do not constitute a "change in control." However, if in the future additional persons are added to the Board of Directors who are not deemed incumbent directors under certain of our employee benefit plans, a "change in control" may occur, which may adversely affect our business. Our stock price is highly volatile. It may be difficult to resell our common stock. Future sales of our common stock by BMS could cause the price of our common stock to decline.

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765258--2/29/2008--IMCLONE_SYSTEMS_INC