1012140--3/5/2007--ONYX_PHARMACEUTICALS

related topics

{product, candidate, development}

{product, liability, claim}

{stock, price, operating}

{provision, law, control}

{control, financial, internal}

{property, intellectual, protect}

{personnel, key, retain}

{acquisition, growth, future}

{cost, regulation, environmental}

{product, market, service}

Even though we have stopped the Phase 3 liver cancer trial, Nexavar may never be approved for use in this indication, or its approval may be significantly delayed. There are competing therapies approved for the treatment of advanced kidney cancer, and we expect the number of approved therapies to rapidly increase, which could harm the prospects for Nexavar in this indication. 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. Our clinical trials could take longer to complete than we project or may not be completed at all. 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. 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 have a history of losses, and we expect to continue to incur losses. We are subject to extensive government regulation, which can be costly, time consuming and subject us to unanticipated delays. While Nexavar has received approvals for sale in several countries outside of the United States, it has not received pricing approval in all of these foreign countries, and may not receive marketing approval in additional countries. We face intense competition and rapid technological change, and many of our competitors have substantially greater resources than we have. We will need substantial additional funds, and our future access to capital is uncertain. We are dependent on the efforts of Bayer to market and promote Nexavar in countries outside the United States where Nexavar has received approval. If Bayer s business strategy changes, it may adversely affect our collaborative relationship. 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. 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. If we lose our key employees and consultants or are unable to attract or retain qualified personnel, our business could suffer. The market may not accept our products and pharmaceutical pricing and reimbursement pressures may reduce profitability. We may not be able to protect our intellectual property or operate our business without infringing upon the intellectual property rights of others. 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 face product liability risks and may not be able to obtain adequate insurance. If we do not receive timely and accurate financial and market information from Bayer regarding the development and sale of Nexavar, we may be unable to accurately report our results of operations. Our stock price is volatile. We are at risk of securities class action litigation due to our expected stock price volatility. Existing stockholders have significant influence over us. Provisions in our collaboration agreement with Bayer may prevent or delay a change in control. Provisions in Delaware law, our charter and executive change of control agreements we have entered into may prevent or delay a change of control.

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1012140--3/5/2007--ONYX_PHARMACEUTICALS_INC