1203866--3/16/2006--PHARMION

related topics

{product, candidate, development}

{product, liability, claim}

{regulation, change, law}

{acquisition, growth, future}

{stock, price, operating}

{property, intellectual, protect}

{provision, law, control}

{personnel, key, retain}

{customer, product, revenue}

{operation, international, foreign}

{tax, income, asset}

{cost, regulation, environmental}

{competitive, industry, competition}

We may not receive regulatory approvals for our product candidates, including thalidomide, satraplatin or, outside of the United States, for Vidaza, or approvals may be delayed. Thalidomide s history of causing birth defects may prevent it from becoming commercially successful. If the third party manufacturers upon whom we rely fail to produce our products in the volumes that we require on a timely basis, or to comply with stringent regulations applicable to pharmaceutical drug manufacturers, we may face delays in the commercialization of, or be unable to meet demand for, our products and may lose potential revenues. Fluctuations in our operating results could affect the price of our common stock. Our effective tax rate has, and likely will continue to, vary significantly from period to period. Increases in our effective tax rate would have a negative effect on our results of operations. If we breach any of the agreements under which we license commercialization rights to products or technology from others, we could lose license rights that are important to our business. We face substantial competition, which may result in others commercializing competing products before or more successfully than we do. The timing of customer purchases and the resulting product shipments have a significant impact on the amount of product sales that we recognize in a particular period. Our failure to successfully acquire, in-license, develop and market additional product candidates or approved products would impair our ability to grow and could affect the price of our common stock. We may not be able to obtain sufficient product liability insurance on commercially reasonable terms or with adequate coverage for thalidomide. Failure to achieve our sales targets or raise additional funds in the future may require us to delay, reduce the scope of, or eliminate one or more of our planned activities. We may not be able to manage our business effectively if we are unable to attract and retain key personnel. We have limited patent protection for our current products, and we may not be able to obtain, maintain and protect proprietary rights necessary for the development and commercialization of our products or product candidates. We may undertake acquisitions in the future and any difficulties from integrating such acquisitions could damage our ability to attain or maintain profitability. Changes to financial accounting standards may affect our results of operations and cause us to change our business practices. Our business is subject to economic, political, regulatory and other risks associated with international sales and operations. Risks Related to Our Industry Our ability to generate sales from our products will depend on reimbursement and drug pricing policies and regulations. If product liability lawsuits are brought against us, we may incur substantial liabilities. If our promotional activities fail to comply with the regulations and guidelines of the various relevant regulatory agencies, we may be subject to warnings or enforcement action that could harm our business. We are subject to numerous complex regulatory requirements and failure to comply with these regulations, or the cost of compliance with these regulations, may harm our business. Risks Related to Our Common Stock Our certificate of incorporation, our bylaws, Delaware law and our employment agreements with members of our senior management contain provisions that could discourage, delay or prevent a change in control or management of Pharmion.

Full 10-K form ▸

1203866--3/16/2006--PHARMION_CORP