1012140--3/16/2006--ONYX_PHARMACEUTICALS

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{product, candidate, development}

{product, liability, claim}

{stock, price, operating}

{provision, law, control}

{acquisition, growth, future}

{personnel, key, retain}

{regulation, change, law}

{control, financial, internal}

{property, intellectual, protect}

{product, market, service}

{cost, regulation, environmental}

Nexavar has not been approved for sale outside of the United States, and may never receive foreign marketing approval. There is a competing therapy approved for the treatment of advanced kidney cancer, and we expect the number of approved therapies could rapidly increase, which could harm the prospects for Nexavar in this indication. If our clinical trials fail to demonstrate that Nexavar is safe and effective for cancer types other than kidney cancer, we will be unable to broadly commercialize Nexavar as a treatment for cancer, and our business may fail. If serious adverse side effects are associated with Nexavar, approval for Nexavar could be revoked, sales of Nexavar could decline, and we may be unable to develop Nexavar as a treatment for other types of cancer. We are dependent upon our collaborative relationship with Bayer to manufacture and to further develop and commercialize Nexavar. There may be circumstances that delay or prevent the development and commercialization of Nexavar. If Bayer s business strategy changes, it may adversely affect our collaborative relationship. Provisions in our collaboration agreement with Bayer may prevent or delay a change in control. Our clinical trials could take longer to complete than we project or may not be completed at all. We face intense competition and rapid technological change, and many of our competitors have substantially greater managerial resources than we have. Our operating results are unpredictable and may fluctuate. If our operating results are below the expectations of securities analysts or investors, the trading price of our stock could decline. We will need substantial additional funds, and our future access to capital is uncertain. If the specialty pharmacies and distributors that we and Bayer rely upon to sell our products fail to perform, our business may be adversely affected. We have a history of losses, and we expect to continue to incur losses. We do not have manufacturing expertise or capabilities and are dependent on Bayer to fulfill our manufacturing needs, which could result in lost sales and the delay of clinical trials or regulatory approval. We have the right to co-promote Nexavar in the United States, but we do not have proven sales or marketing expertise. We will be dependent on the efforts of Bayer to market and promote Nexavar in countries outside the United States where Nexavar may receive approval. If we lose our key employees and consultants or are unable to attract or retain qualified personnel, our business could suffer. We have rapidly expanded our sales and marketing operations, and any difficulties managing this growth could disrupt our operations. The market may not accept our products and pharmaceutical pricing and reimbursement pressures may reduce profitability. We are subject to extensive government regulation, which can be costly, time consuming and subject us to unanticipated delays. We may incur significant liability if it is determined that we are promoting the off-label use of drugs or are otherwise found in violation of federal and state regulations in the United States or elsewhere. We may not be able to protect our intellectual property or operate our business without infringing upon the intellectual property rights of others. We face product liability risks and may not be able to obtain adequate insurance. Our stock price is volatile. Existing stockholders have significant influence over us. We are at risk of securities class action litigation due to our expected stock price volatility. Provisions in Delaware law, our charter and executive change of control agreements we have entered into may prevent or delay a change of control. Accounting pronouncements may affect our future financial position and results of operations.

Full 10-K form ▸

1012140--3/16/2006--ONYX_PHARMACEUTICALS_INC