882095--2/27/2007--GILEAD_SCIENCES

related topics

{product, candidate, development}

{customer, product, revenue}

{product, liability, claim}

{property, intellectual, protect}

{regulation, government, change}

{operation, international, foreign}

{tax, income, asset}

{personnel, key, retain}

{loss, insurance, financial}

{financial, litigation, operation}

{regulation, change, law}

{capital, credit, financial}

Substantially all of our revenues are derived from sales of a limited number of products. If we are unable to maintain or continue increasing sales of our HIV products, our results of operations may be adversely affected. If we fail to commercialize new products or expand the indications for existing products, our prospects for future revenues and our stock price may be adversely affected. If significant safety issues arise for our marketed products or our product candidates, our future sales may be reduced, which would adversely affect our results of operations. Our operations depend on compliance with complex FDA and comparable international regulations. Failure to obtain broad approvals on a timely basis or to achieve continued compliance could delay or halt commercialization of our products. The results of our clinical trials are uncertain and may not support continued development of a product pipeline, which would adversely affect our prospects for future revenue growth. Due to our reliance on third-party contract research organizations to conduct clinical trials, we are unable to directly control the timing, conduct, expense and quality of our clinical trials. We may not be able to successfully integrate our existing business with the businesses of Corus Pharma, Inc., Raylo Chemicals Inc., and Myogen, Inc. Manufacturing problems could delay product shipments and regulatory approvals, which may adversely affect our results of operations. We may not be able to manufacture AmBisome and Macugen to meet market needs in the event of business interruptions at our San Dimas facility. Our ability to successfully manufacture and commercialize aztreonam lysine, if approved, will depend upon our ability to continue to manufacture in a multi-product facility. We may not be able to obtain materials or supplies necessary to manufacture or sell our products, which could limit our ability to generate revenues. We depend on relationships with other companies for sales and marketing performance and revenues. Failure to maintain these relationships, poor performance by these companies or disputes with these other companies could negatively impact our business. Expenses associated with clinical trials and sales fluctuations as a result of inventory levels held by wholesalers may cause our earnings to fluctuate, which could adversely affect our stock price. Our success will depend to a significant degree on our ability to protect our patents and other intellectual property rights both domestically and internationally. Our success depends in large part on our ability to operate without infringing upon the patents or other proprietary rights of third parties. Approximately half of our product sales occur outside the United States, and currency fluctuations may cause our earnings to fluctuate, which could adversely affect our stock price. We face credit risks from our European customers that may adversely affect our results of operations. Our product revenues could be reduced by imports from countries where our products are available at lower prices. In some countries, we may be required to grant compulsory licenses for our products or face generic competition for our products. Our existing products are subject to reimbursement from government agencies and other third parties. Pharmaceutical pricing and reimbursement pressures may reduce profitability. Our results of operations could be adversely affected by current and future health care reforms. We may not be able to obtain effective patents to protect our technologies from use by competitors and patents of other companies could require us to stop using or pay for the use of required technology. We may face significant liability resulting from our products that may not be covered by insurance and successful claims could materially reduce our earnings. Our assumptions used to determine our self-insurance levels could be wrong and materially impact our business. Expensive litigation and government investigations may reduce our earnings. Changes in our effective income tax rate could reduce our earnings. Changes in accounting for stock options has significantly reduced and will continue to significantly reduce our earnings. If we fail to attract and retain highly qualified personnel, we may be unable to successfully develop new product candidates, conduct our clinical trials and commercialize our product candidates.

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882095--2/27/2007--GILEAD_SCIENCES_INC