702131--3/1/2007--MGI_PHARMA

related topics

{product, liability, claim}

{product, candidate, development}

{control, financial, internal}

{financial, litigation, operation}

{customer, product, revenue}

{cost, regulation, environmental}

{stock, price, share}

{product, market, service}

{acquisition, growth, future}

{property, intellectual, protect}

{stock, price, operating}

{personnel, key, retain}

{tax, income, asset}

{condition, economic, financial}

We have licensed the right to promote, sell and distribute Aloxi products in the United States and Canada from Helsinn Healthcare SA. We are particularly dependent on Helsinn for our ability to commercialize Aloxi products. In addition to Aloxi, we will depend on revenues from Dacogen to grow our business. In the future, we will also depend on maintaining or increasing revenues from Gliadel, the failure of which would have an adverse effect on our ability to accomplish our business objectives. If we fail to compete successfully with our competitors, our product revenues could decrease and our stock price could decline. We rely on our products, other than Aloxi, Dacogen and Gliadel, to fulfill our business objectives as a supportive and acute care company. Our ability to achieve strong revenue growth for Gliadel, Aquavan, and Dacogen may depend on the results of additional clinical trials. We depend on a single supplier to provide us with the finished drug product for Aloxi and Dacogen and single suppliers to provide us with the active ingredients for other product candidates. If the suppliers terminate their relationships with us, or are unable to fill our demand for the ingredients or products, we may be unable to sell Aloxi or Dacogen, and the development of our product candidates could be delayed or if a product candidate is approved, the commercial launch could be delayed. If the third-party manufacturer of Aloxi or Dacogen or any of our other products ceases operations or fails to comply with applicable manufacturing regulations, we may not be able to meet customer demand in a timely manner, if at all. Our operating results fluctuate significantly, which may adversely affect our stock price. Our effective tax rate may vary significantly from period to period. Increases in our effective tax rate would have a negative effect on our results of operations. If we are unable to maintain relationships with strategic collaborators or enter into new relationships, we may not be able to develop any of our product candidates or commercialize our products in a timely manner, if at all. We rely on multinational and foreign pharmaceutical companies to develop and commercialize our products and product candidates in markets outside the United States. Our customer base is highly concentrated. Bankruptcy or financial distress of any of our customers would adversely affect our financial condition and fluctuations in their purchases of our products would cause volatility in our results of operations. The timing of customer purchases and the resulting product shipments have a significant impact on the amount of revenue from product sales that we recognize in a particular period. If we or patients using our products are unable to obtain adequate reimbursement from government health administration authorities, private health insurers and other organizations, our product sales, net income, cash balances and price of our stock could decline. Clinical trials are complex and unpredictable and may be difficult to complete or produce unexpected results that could delay or prevent our ability to commercialize our product candidates. Our products are subject to ongoing regulatory review. Because our product candidates such as Aquavan, Saforis, amolimogene bepiplasmid, ZYC300 and irofulven may have alternative development paths and we have limited resources, our focus on a particular development path for these product candidates may result in our failure to capitalize on more profitable areas and may not result in viable products. We may need to obtain additional capital to grow our business and complete our product portfolio development and expansion plans. Issuance of new securities may dilute the interests of our stockholders and constrain our operating flexibility. If we do not receive regulatory approvals for our product candidates, or if regulatory approval is delayed for any reason, we will be unable to commercialize and sell our products as we expect. Our business strategy depends on our ability to acquire, research, license and develop product candidates and discover, acquire or license approved products. If we are not able to undertake these activities successfully, we will not be able to achieve our corporate goals. We may not realize all of the anticipated benefits of our recent and future acquisitions. Our promotional activities are subject to extensive regulation from the FDA, the Federal Trade Commission ( FTC ), the Office of the Inspector General of the U.S. Department of Health and Human Services ( OIG ), or State Attorney Generals. If we violate any such regulations it could be damaging to our reputation and restrict our ability to sell or market our products, and our business condition could be adversely affected. If the use of one of our products is alleged to be harmful, we may be subject to costly and damaging product liability claims. If we are unable to keep up with rapid technological changes in the pharmaceutical or biotechnology industries, we may be unable to continue our operations. If we are unable to obtain intellectual property protection, or protect our proprietary technology, we may be unable to compete effectively. We could become the subject of legal proceedings or investigations that could result in substantial fines, penalties, injunctive or administrative penalties and criminal charges, which would increase our expenses and redirect management s attention away from business operations. If we issue a product recall, we may not sell as much of our products in the future and we may incur significant expenses. Our operations, and the operations of our third-party contractors, involve hazardous materials that could expose us to liability if environmental damage occurs. We are dependent on our key personnel. If we are not able to attract and retain key employees and consultants, our product development, marketing and commercialization plans could be harmed. Our stock price is volatile, which may result in significant losses to stockholders and holders of our convertible notes. We have outstanding options, convertible notes and warrants that have the potential to dilute stockholder value and cause our stock value to decline.

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702131--3/1/2007--MGI_PHARMA_INC