1002637--3/1/2007--MILLENNIUM_PHARMACEUTICALS

related topics

{product, candidate, development}

{product, liability, claim}

{property, intellectual, protect}

{acquisition, growth, future}

{financial, litigation, operation}

{debt, indebtedness, cash}

{stock, price, operating}

{personnel, key, retain}

{provision, law, control}

{cost, operation, labor}

{control, financial, internal}

{stock, price, share}

Our business may be harmed if we do not obtain approval to market VELCADE for additional therapeutic uses. We may not be able to obtain approval in additional countries to market VELCADE. We may not be able to obtain marketing approval for products resulting from our development efforts. If we fail to comply with regulatory requirements, or if we experience unanticipated problems with our approved products, our products could be subject to restrictions or withdrawal from the market. Some of our products may be based on new technologies, which may affect our ability or the time we require to obtain necessary regulatory approvals. Risks Relating to Our Business, Strategy and Industry Our revenues over the next several years will be materially dependent on the commercial success of VELCADE and INTEGRILIN. We face substantial competition, and others may discover, develop or commercialize products before or more successfully than we do. Sales of INTEGRILIN and possibly VELCADE in particular reporting periods may be affected by fluctuations in inventory, allowances and buying patterns. Because our research and development projects are based on new technologies and new therapeutic approaches that have not been extensively tested in humans, it is possible that our discovery process will not result in commercial products. If our clinical trials are unsuccessful, or if they experience significant delays, our ability to commercialize products will be impaired. 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 or commercialize our product candidates. Because many of the products that we are developing are based on new technologies and therapeutic approaches, the market may not be receptive to these products upon their introduction. Because of the high demand for talented personnel within our industry, we could experience difficulties in recruiting employees necessary for our success and growth. Our strategy of generating growth through license arrangements and acquisitions may not be successful. If we fail to successfully manage any acquisitions, our ability to develop our product candidates and expand our product candidate pipeline may be harmed. Risks Relating to Our Financial Results and Need for Financing We have incurred substantial losses and expect to continue to incur losses. We will not be successful unless we reverse this trend. We may need additional financing, which may be difficult to obtain. Our failure to obtain necessary financing or doing so on unattractive terms could adversely affect our business and operations. Our indebtedness and debt service obligations may adversely affect our cash flow and otherwise negatively affect our operations. If we do not achieve the anticipated benefits of our restructuring efforts, or if the costs of our restructuring efforts exceed anticipated levels, our business could be harmed. We received an informal inquiry from the Securities and Exchange Commission regarding stock options that we granted in September 2001. If the Securities and Exchange Commission, or SEC, does not agree with our conclusion regarding the accounting for such options and determines that we have incorrectly accounted for historical stock option grants, and if the associated expense not previously recorded is material, we likely would be required to restate certain historical financial statements and could become subject to litigation. We depend significantly on our collaborators to work with us to commercialize and develop products including VELCADE and INTEGRILIN. We are substantially dependent on SGP for future revenues related to INTEGRILIN. We may not be successful in establishing additional strategic alliances, which could adversely affect our ability to develop and commercialize products. Risks Relating to Intellectual Property If we are unable to obtain patent protection for our discoveries, the value of our technology and products will be adversely affected. If we infringe patent or other intellectual property rights of third parties, we may not be able to develop and commercialize our products or the cost of doing so may increase. There is significant uncertainty about the validity and permissible scope of patents in our industry, which may make it difficult for us to obtain patent protection for our discoveries. Third parties may own or control patents or patent applications and require us to seek licenses, which could increase our development and commercialization costs, or prevent us from developing or marketing our products. We may become involved in expensive patent litigation or other proceedings, which could result in our incurring substantial costs and expenses or substantial liability for damages or require us to stop our development and commercialization efforts. Our patent protection for any compounds that we seek to develop may be limited to a particular method of use or indication such that, if a third party were to obtain approval of the compound for use in another indication, we could be subject to competition arising from off-label use. If we fail to comply with our obligations in our intellectual property licenses with third parties, we could lose license rights that are important to our business. Competition from generic pharmaceutical manufacturers could negatively impact our products sales. Risks Relating to Product Manufacturing, Marketing and Sales Because we have limited sales, marketing and distribution experience and capabilities, in some instances we are dependent on third parties to successfully perform these functions on our behalf, or we may be required to incur significant costs and devote significant efforts to augment our existing capabilities. Because we have no commercial manufacturing capabilities, we will continue to be dependent on third party manufacturers to manufacture products for us, or we will be required to incur significant costs and devote significant efforts to establish our own manufacturing facilities and capabilities. Because we have no commercial manufacturing capability for VELCADE and INTEGRILIN, we are dependent on third parties to produce product sufficient to meet market demand. If we fail to obtain an adequate level of reimbursement for our products by third party payors, there may be no commercially viable markets for our products. We face a risk of product liability claims and may not be able to obtain insurance. We face a risk of government enforcement actions in connection with marketing activities. Guidelines and recommendations can affect the use of our products. Risks Relating to Holding Our Common Stock The trading price of our common stock could be subject to significant fluctuations. We have anti-takeover defenses that could delay or prevent an acquisition and could adversely affect the price of our common stock.

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1002637--3/1/2007--MILLENNIUM_PHARMACEUTICALS_INC