1131324--3/13/2009--GENOMIC_HEALTH

related topics

{product, candidate, development}

{product, liability, claim}

{product, market, service}

{acquisition, growth, future}

{property, intellectual, protect}

{cost, regulation, environmental}

{customer, product, revenue}

{system, service, information}

{personnel, key, retain}

{operation, international, foreign}

{regulation, change, law}

{loan, real, estate}

We depend on a limited number of payors for a significant portion of our product revenues and if these or other payors stop providing reimbursement or decrease the amount of reimbursement for our test, our revenues could decline. If FDA were to begin regulating our test, we could be forced to stop sales of Oncotype DX, we could incur substantial costs and time delays associated with meeting requirements for pre-market clearance or approval or we could experience decreased demand for or reimbursement of our test. If we were required to conduct additional clinical trials prior to continuing to sell Oncotype DX or marketing any new test, those trials could lead to delays or failure to obtain necessary regulatory approval, which could cause significant delays in commercializing any future products and harm our ability to become profitable. Complying with numerous regulations pertaining to our business is an expensive and time-consuming process, and any failure to comply could result in substantial penalties. Our financial results depend on sales of one test, Oncotype DX, and we will need to generate sufficient revenues from this and other tests to run our business. New test development involves a lengthy and complex process, and we may be unable to commercialize any of the tests we are currently developing. If we are unable to support demand for our tests, our business may suffer. We may experience limits on our revenues if physicians decide not to order our test. We may experience limits on our revenues if patients decide not to use our test. If we are unable to develop products to keep pace with rapid technological, medical and scientific change, our operating results and competitive position would be harmed. Our rights to use technologies licensed from third parties are not within our control, and we may not be able to sell our products if we lose our existing rights or cannot obtain new rights on reasonable terms. Our competitive position depends on maintaining intellectual property protection. We may face intellectual property infringement claims that could be time-consuming and costly to defend and could result in our loss of significant rights and the assessment of treble damages. If we are unable to compete successfully, we may be unable to increase or sustain our revenues or achieve profitability. Our research and development efforts will be hindered if we are not able to contract with third parties for access to archival tissue samples. If we cannot maintain our current clinical collaborations and enter into new collaborations, our product development could be delayed. The loss of key members of our senior management team or our inability to retain highly skilled scientists, clinicians and salespeople could adversely affect our business. If our sole laboratory facility becomes inoperable, we will be unable to perform our test and our business will be harmed. We are dependent on our information technology and telecommunications systems, and any failure of these systems could harm our business. Changes in healthcare policy could subject us to additional regulatory requirements that may interrupt sales of Oncotype DX and increase our costs. We rely on a limited number of suppliers or, in some cases, a sole supplier, for some of our laboratory instruments and materials and may not be able to find replacements in the event our suppliers no longer supply that equipment or those materials. We may be unable to manage our future growth effectively, which would make it difficult to execute our business strategy. If we were sued for product liability or professional liability, we could face substantial liabilities that exceed our resources. If we use biological and hazardous materials in a manner that causes injury, we could be liable for damages. International expansion of our business may expose us to business, regulatory, political, operational, financial and economic risks associated with doing business outside of the United States. Our dependence on distributors for sales of Oncotype DX outside of the U.S. could limit or prevent us from selling our test in other markets and from realizing long-term international revenue growth. We may acquire other businesses or form joint ventures that could harm our operating results, dilute our stockholders ownership, increase our debt or cause us to incur significant expense. Our marketable securities are subject to risks that could adversely affect our overall financial position. Our inability to raise additional capital on acceptable terms in the future may limit our ability to develop and commercialize new tests and technologies.

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1131324--3/13/2009--GENOMIC_HEALTH_INC