1100412--8/12/2010--ARRAY_BIOPHARMA_INC

related topics
{product, candidate, development}
{stock, price, operating}
{acquisition, growth, future}
{regulation, government, change}
{property, intellectual, protect}
{product, liability, claim}
{product, market, service}
{control, financial, internal}
{operation, natural, condition}
{regulation, change, law}
{cost, regulation, environmental}
{personnel, key, retain}
{tax, income, asset}
{customer, product, revenue}
{investment, property, distribution}
We have a history of operating losses and may not achieve or sustain profitability. We may not be successful in entering into additional out-license agreements on favorable terms, which may adversely affect our liquidity or require us to change our spending priorities on our proprietary programs. We may not receive royalty or milestone revenue under our collaboration agreements for several years, or at all. Our drug candidates are at early stages of development and we may not successfully develop a drug candidate that becomes a commercially viable drug. We or our collaborators may choose not to commercialize a drug candidate at any time during development, which would reduce or eliminate our potential return on investment for that drug. Our capital requirements could significantly increase if we choose to develop more of our proprietary programs internally. We may not out-license our proprietary programs at the most appropriate time to maximize the total value or return of these programs to us. Because we rely on a small number of collaborators for a significant portion of our revenue, if one or more of our major collaborators terminates or reduces the scope of their agreement with us, our revenue may significantly decrease. If we need, but are unable to obtain, additional funding to support our operations, we could be unable to successfully execute our operating plan or be forced to reduce our operations. Recent disruptions in the financial markets could affect our ability to obtain financing for development of our proprietary drug programs and other purposes on reasonable terms and have other adverse effects on us and the market price of our common stock. Our investments in ARS are not currently liquid and our inability to access these funds may adversely affect our liquidity, capital resources and results of operations. If the issuers of our ARS are unable to successfully close future auctions and credit ratings continue to deteriorate, we may be required to further adjust the carrying value of our investments through additional impairment charges. If our drug discovery and development programs do not progress as anticipated, our revenue and stock price could be negatively impacted. We may not realize anticipated benefits from future acquisitions, investments and strategic partnerships. We may not be able to recruit and retain the experienced scientists and management we need to compete in the drug research and development industry. Risks Related to Our Clinical Development Activities and Obtaining Regulatory Approval for Our Programs We have limited clinical development and commercialization experience. If we fail to adequately conduct clinical trials, we may not obtain regulatory approvals necessary for the sale of drugs when anticipated, or at all, which would reduce or eliminate our potential return on that program. Delays in the commencement or completion of clinical testing could result in increased costs to us and delay or limit our ability to generate revenues. Drug candidates that we develop with our collaborators or on our own may not receive regulatory approval. Even if our drug candidates obtain regulatory approval, we and our collaborators will be subject to ongoing government regulation. If our drug candidates do not gain market acceptance, we may be unable to generate significant revenue. Our collaborators have substantial control and discretion over the timing and the continued development and marketing of drug candidates we create for them. Our cGMP and Pharmacology facilities and practices may fail to comply with government regulations. Our development, testing and manufacture of drug candidates may expose us to product liability and other lawsuits. If our use of chemical and hazardous materials violates applicable laws or regulations or causes personal injury we may be liable for damages. Our operations could be interrupted by damage to our specialized laboratory facilities. Due to our reliance on contract research organizations and other third parties to conduct our clinical trials, we are unable to directly control the timing, conduct and expense of our clinical trials. Controls we or our third-party service providers have in place to ensure compliance with laws may not be effective to ensure compliance with all applicable laws and regulations. Risks Related to Our Drug Discovery Activities Revenue from collaborations depends on the extent to which the pharmaceutical and biotechnology industries collaborate with other companies for one or more aspects of their drug discovery process. Our research and development capabilities may not produce viable drug candidates. Risks Related To Our Industry The concentration of the pharmaceutical and biotechnology industry and any further consolidation could reduce the number of our potential collaborators. Capital market conditions may reduce our biotechnology collaborators ability to fund research and development. Health care reform, including those based on recently enacted legislation and cost control initiatives by third-party payors could reduce the prices that can be charged for drugs, which could limit the commercial success of our drug candidates. We, or our collaborators, may not obtain favorable reimbursement rates for our drug candidates. The drug research and development industry has a history of patent and other intellectual property litigation and we may be involved in costly intellectual property lawsuits. The intellectual property rights we rely on to protect our proprietary drug candidates and the technology underlying our tools and techniques may be inadequate to prevent third parties from using our technology or developing competing capabilities or to protect our interests in our proprietary drug candidates. Agreements we have with our employees, consultants and collaborators may not afford adequate protection for our trade secrets, confidential information and other proprietary information. The drug research and development industry is highly competitive and we compete with some companies that offer a broader range of capabilities and have better access to resources than we do. We face potential liability related to the privacy of health information we obtain from research institutions. Risks Related To Our Stock Our officers and directors have significant control over us and their interests may differ from those of our stockholders. Our quarterly operating results could fluctuate significantly, which could cause our stock price to decline. Because our stock price may be volatile, our stock price could experience substantial declines.

Full 10-K form ▸

related documents
1100412--8/18/2009--ARRAY_BIOPHARMA_INC
901219--3/2/2010--HUMAN_GENOME_SCIENCES_INC
1145404--3/16/2007--CRITICAL_THERAPEUTICS_INC
906709--3/16/2006--NEKTAR_THERAPEUTICS
919722--3/16/2006--SUPERGEN_INC
1340744--3/30/2006--Altus_Pharmaceuticals_Inc.
1107332--3/12/2008--DENDREON_CORP
1128495--3/3/2009--ANADYS_PHARMACEUTICALS_INC
1212235--4/2/2007--XTENT_INC
1100412--8/15/2008--ARRAY_BIOPHARMA_INC
1101052--3/15/2006--MYOGEN_INC
1002637--3/8/2006--MILLENNIUM_PHARMACEUTICALS_INC
1162192--3/31/2008--AVALON_PHARMACEUTICALS_INC
1178879--3/10/2010--AMICUS_THERAPEUTICS_INC
1001233--3/3/2009--SANGAMO_BIOSCIENCES_INC
1157601--3/11/2010--SYNTA_PHARMACEUTICALS_CORP
902622--3/15/2006--ICAGEN_INC
1130591--2/22/2008--XENOPORT_INC
831547--3/14/2008--SPECTRUM_PHARMACEUTICALS_INC
1130591--3/7/2007--XENOPORT_INC
1108271--3/16/2006--CONOR_MEDSYSTEMS_INC
1142576--3/30/2007--OPTIMER_PHARMACEUTICALS_INC
1142576--3/26/2008--OPTIMER_PHARMACEUTICALS_INC
1002637--3/1/2007--MILLENNIUM_PHARMACEUTICALS_INC
1333248--3/28/2007--CADENCE_PHARMACEUTICALS_INC
1212235--3/24/2009--XTENT_INC
1145404--3/28/2008--CRITICAL_THERAPEUTICS_INC
1145404--3/7/2006--CRITICAL_THERAPEUTICS_INC
1344413--3/9/2010--Alexza_Pharmaceuticals_Inc.
1344413--3/10/2009--Alexza_Pharmaceuticals_Inc.