1124140--3/15/2006--EXACT_SCIENCES_CORP

related topics
{product, candidate, development}
{product, liability, claim}
{property, intellectual, protect}
{product, market, service}
{stock, price, operating}
{regulation, government, change}
{acquisition, growth, future}
{gas, price, oil}
{personnel, key, retain}
{provision, law, control}
{customer, product, revenue}
We may never successfully commercialize any of our technologies or become profitable. If we or LabCorp fail to comply with FDA requirements, we or LabCorp may be limited or prohibited in our ability to commercialize stool-based DNA testing for colorectal cancer and may be subject to stringent penalties. Our ability to generate revenue depends on LabCorp s commercial sales of PreGen-Plus. Our business is substantially dependent on the success of our strategic agreement with LabCorp. If Medicare and other third-party payors, including managed care organizations, do not issue positive policy decisions approving reimbursement for PreGen-Plus, the commercial success of PreGen-Plus would be compromised. Our business would suffer if we, or LabCorp, are unable to license certain technologies or obtain raw materials and components or if certain of our licenses were terminated. If our clinical studies do not prove the superiority, reliability, or effectiveness of stool-based DNA testing, we may experience reluctance or refusal on the part of guidelines writers to include stool-based DNA testing within screening guidelines as well as a reluctance or refusal on the part of physicians to order, and third-party payors to pay for tests based on PreGen-Plus. If PreGen-Plus cannot be effectively sold at a price acceptable to the market or acceptable to the writers of screening guidelines, the successful commercialization of PreGen-Plus would be materially harmed. If the Effipure technology and our or LabCorp s other technological advancements do not increase the performance of PreGen-Plus in a cost effective manner, the demand for PreGen-Plus may be negatively impacted If an insufficient number of medical practitioners order and reorder tests using our technologies, our revenue and profitability will be limited. We may experience limits on our revenue if only a small number of people decide to be screened for colorectal cancer using our technologies. We may be subject to substantial costs and liability or be prevented from licensing our technologies for cancer detection as a result of litigation or other proceedings relating to patent rights. If we are unable to protect our intellectual property effectively, we may be unable to prevent third parties from using our intellectual property, which would impair our competitive advantage. Other companies may develop and market novel or improved methods for detecting colorectal cancer, which may make our technologies less competitive, or even obsolete. We rely on third-party contract manufacturers and suppliers and may experience a scarcity of raw materials and components. If the Effipure technology is replaced in commercial use by new or improved technologies, existing Effipure inventories could become obsolete, which could require the write-off of existing inventory that would negatively impact our gross margins and profitability. If we or our partners fail to comply with regulatory requirements, we may be subject to stringent penalties and our business may be materially adversely affected. The loss of key members of our senior management team could adversely affect our business. If weare unable to attract the expertise necessary to develop and seek regulatory approval for an in vitro diagnostic kit, we may not be able to bring more advanced technologies to market If we lose the support of our key scientific collaborators, it may be difficult to establish tests using our technologies as a standard of care for colorectal cancer screening, which may limit our revenue growth and profitability. Our inability to apply our proprietary technologies successfully to detect other common cancers may limit our future revenue growth and profitability. Our inability to raise additional capital on acceptable terms in the future may limit our growth. Product liability suits against us could result in expensive and time-consuming litigation, payment of substantial damages and increases in our insurance rates. Certain provisions of our charter, by-laws and Delaware law may make it difficult for you to change our management and may also make a takeover difficult. Our stock price may be volatile. Our operating results may fluctuate, which may adversely affect our share price.

Full 10-K form ▸

related documents
1124140--3/15/2007--EXACT_SCIENCES_CORP
1124140--3/17/2008--EXACT_SCIENCES_CORP
765258--2/29/2008--IMCLONE_SYSTEMS_INC
1047188--3/16/2006--PENWEST_PHARMACEUTICALS_CO
765258--3/1/2007--IMCLONE_SYSTEMS_INC
815838--3/15/2006--NOVEN_PHARMACEUTICALS_INC
1012140--2/23/2010--ONYX_PHARMACEUTICALS_INC
890465--3/14/2007--NPS_PHARMACEUTICALS_INC
765258--3/16/2006--IMCLONE_SYSTEMS_INC
1029142--3/17/2008--DYNAVAX_TECHNOLOGIES_CORP
918112--9/16/2008--NEUROBIOLOGICAL_TECHNOLOGIES_INC_/CA/
887708--6/10/2008--CARACO_PHARMACEUTICAL_LABORATORIES_LTD
884847--3/21/2006--MATRITECH_INC/DE/
883975--3/11/2010--STEMCELLS_INC
1160308--3/16/2006--ADVENTRX_PHARMACEUTICALS_INC
890465--3/3/2006--NPS_PHARMACEUTICALS_INC
792977--12/1/2006--ADVANCED_MAGNETICS_INC
942788--3/16/2007--NEOPHARM_INC
918112--9/13/2007--NEUROBIOLOGICAL_TECHNOLOGIES_INC_/CA/
1093557--2/27/2007--DEXCOM_INC
949858--3/14/2008--SONUS_PHARMACEUTICALS_INC
1124140--3/31/2009--EXACT_SCIENCES_CORP
72444--3/11/2009--NABI__BIOPHARMACEUTICALS
936402--3/1/2006--Shire_plc
1037760--3/15/2007--CEPHEID
72444--2/28/2008--NABI__BIOPHARMACEUTICALS
356591--3/26/2010--NEUROLOGIX_INC/DE
1037760--2/29/2008--CEPHEID
792977--2/27/2009--AMAG_PHARMACEUTICALS_INC.
1114529--3/31/2006--VIACELL_INC