1012140--2/23/2010--ONYX_PHARMACEUTICALS_INC

related topics
{product, candidate, development}
{product, liability, claim}
{stock, price, operating}
{property, intellectual, protect}
{control, financial, internal}
{acquisition, growth, future}
{capital, credit, financial}
{provision, law, control}
{debt, indebtedness, cash}
{operation, international, foreign}
{tax, income, asset}
{cost, operation, labor}
{operation, natural, condition}
{condition, economic, financial}
{cost, regulation, environmental}
{personnel, key, retain}
{regulation, change, law}
{product, market, service}
Adoption of Nexavar in certain territories for the treatment of patients with unresectable liver cancer may be slow or limited for a variety of reasons including the geographic distribution of the patient population, the current treatment paradigm for unresectable liver cancer patients, the underlying liver disease present in most liver cancer patients and limited reimbursement. If Nexavar is not broadly adopted for the treatment of unresectable liver cancer, our business would be harmed. If our ongoing and planned clinical trials fail to demonstrate that Nexavar is safe and effective or we are unable to obtain necessary regulatory approvals, we will be unable to expand the commercial market for Nexavar 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. Specialty pharmacies and distributors that we and Bayer rely upon to sell Nexavar may fail to perform. We are dependent upon our collaborative relationship with Bayer to further develop, manufacture and commercialize Nexavar. There may be circumstances that delay or prevent Bayer s ability to develop, manufacture and commercialize Nexavar. Nexavar may face challenges and competition from generic products. The market may not accept our products and we may be subject to pharmaceutical pricing and third-party reimbursement pressures. We face intense competition and rapid technological change, and many of our competitors have substantially greater resources than we have. If we are not successful at integrating the Proteolix organization with ours, we may not be able to realize benefits from our acquisition. Our clinical trials could take longer to complete than we project or may not be completed at all, and; we may never obtain regulatory approval for carfilzomib or any other future product candidate. We do not have the manufacturing expertise or capabilities for any current and future products and are dependent on others to fulfill our manufacturing needs, which could result in lost sales and the delay of clinical trials or regulatory approval. If we lose our key employees or are unable to attract or retain qualified personnel, our business could suffer. We may not be able to realize the potential financial or strategic benefits of future business acquisitions or strategic investments, which could hurt our ability to grow our business, develop new products or sell our products. We face product liability risks and may not be able to obtain adequate insurance. We or Bayer may not be able to protect or enforce our or their intellectual property and we may not be able to operate our business without infringing the intellectual property rights of others. Limited foreign intellectual property protection and compulsory licensing could limit our revenue opportunities. 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. Unstable market and economic conditions may have serious adverse consequences on our business. We are subject to extensive government regulation, which can be costly, time consuming and subject us to unanticipated delays. If we are unable to obtain or maintain regulatory approvals for our products, compounds or product candidates, we will not be able to market or further develop them. If we use hazardous or potentially hazardous materials in a manner that causes injury or violates applicable law, we may be liable for damages. Our operating results are unpredictable and may fluctuate. If our operating results fail to meet the expectations of securities analysts or investors, the trading price of our stock could decline. Our stock price is volatile and we are at risk of securities litigation, including class action litigation, due to our expected stock price volatility. We have a history of losses, and we may be unable to sustain profitability. We incurred significant indebtedness through the sale of our 4.0% convertible senior notes due 2016, and we may incur additional indebtedness in the future. The indebtedness created by the sale of the notes and any future indebtedness we incur exposes us to risks that could adversely affect our business, financial condition and results of operations. The conditional conversion features of the 2016 Notes, if triggered, may adversely affect our financial condition and operating results. We may need additional funds, and our future access to capital is uncertain. A portion of our investment portfolio is invested in auction rate securities, and if auctions continue to fail for amounts we have invested, our investment will not be liquid. If the issuer of an auction rate security that we hold is unable to successfully close future auctions and their credit rating deteriorates, we may be required to adjust the carrying value of our investment through an impairment charge to earnings. If we do not receive timely and accurate financial information from Bayer regarding the development and sale of Nexavar, we may be unable to accurately report our results of operations. Our operating results could be adversely affected by product sales occurring outside the United States and fluctuations in the value of the United States dollar against foreign currencies. Changes in accounting may affect our financial position and results of operations. Provisions in our collaboration agreement with Bayer may prevent or delay a change in control. Existing stockholders have significant influence over us.

Full 10-K form ▸

related documents
890465--3/14/2007--NPS_PHARMACEUTICALS_INC
765258--3/1/2007--IMCLONE_SYSTEMS_INC
1124140--3/15/2006--EXACT_SCIENCES_CORP
765258--2/29/2008--IMCLONE_SYSTEMS_INC
1114529--3/31/2006--VIACELL_INC
1124140--3/17/2008--EXACT_SCIENCES_CORP
883975--3/11/2010--STEMCELLS_INC
1105184--3/11/2010--NANOSPHERE_INC
1203957--3/13/2008--BIONOVO_INC
1203866--3/16/2006--PHARMION_CORP
883975--3/14/2008--STEMCELLS_INC
72444--3/11/2009--NABI__BIOPHARMACEUTICALS
1047188--3/16/2006--PENWEST_PHARMACEUTICALS_CO
942788--3/16/2007--NEOPHARM_INC
72444--2/28/2008--NABI__BIOPHARMACEUTICALS
918112--9/13/2007--NEUROBIOLOGICAL_TECHNOLOGIES_INC_/CA/
1124140--3/15/2007--EXACT_SCIENCES_CORP
884847--3/21/2006--MATRITECH_INC/DE/
883975--3/16/2009--STEMCELLS_INC
1037760--3/15/2007--CEPHEID
702131--3/1/2007--MGI_PHARMA_INC
918112--9/16/2008--NEUROBIOLOGICAL_TECHNOLOGIES_INC_/CA/
1131907--3/16/2006--CANCERVAX_CORP
1203866--2/29/2008--PHARMION_CORP
1203866--3/15/2007--PHARMION_CORP
879993--3/11/2009--DUSA_PHARMACEUTICALS_INC
907562--2/29/2008--DYAX_CORP
887247--4/2/2007--CELLEGY_PHARMACEUTICALS_INC
821616--3/15/2007--BENTLEY_PHARMACEUTICALS_INC
792977--2/27/2009--AMAG_PHARMACEUTICALS_INC.