899923--9/7/2006--MYRIAD_GENETICS

related topics

{product, candidate, development}

{property, intellectual, protect}

{stock, price, share}

{product, liability, claim}

{acquisition, growth, future}

{personnel, key, retain}

{provision, law, control}

{control, financial, internal}

{regulation, government, change}

{cost, regulation, environmental}

{stock, price, operating}

Risks Related to Our Business and Our Strategy We are a company in the early stages of development and commercialization and may never achieve the goals of our business plan. We depend heavily on the success of our lead product candidate, Flurizan, which is still under development. We have a history of operating losses and expect to continue to incur losses in the future. If our current operating plan changes and we find that our existing capital resources will not meet our needs, we may find it necessary to raise additional funding, which funding may not be available. We have limited sources of revenue and if we are unable to secure additional funding, we will have to reduce or discontinue operations. If we were successfully sued for product liability, we could face substantial liabilities that exceed our resources. Our business involves environmental risks that may result in liability for us. Risks Related to Regulatory Approval of Our Drug Candidates and Other Government Regulations If we do not obtain required regulatory approval, we will be unable to market and sell our therapeutic candidates. Our clinical trials may not yield results that will enable us to obtain regulatory approval for our therapeutic candidates. Because our therapeutic candidates are in an early stage of development, there is a high risk of failure, and we may never succeed in developing marketable products or generating product revenue. If clinical trials for our therapeutic candidates are prolonged or delayed, we may be unable to commercialize our therapeutic candidates on a timely basis, which would require us to incur additional costs and delay our receipt of any revenue from potential product sales. If we encounter difficulties enrolling subjects in our clinical trials, or subjects drop out of trials in progress, our trials could be delayed or otherwise adversely affected. Failure to comply with foreign regulatory requirements governing human clinical trials and marketing approval for drugs could prevent us from selling our drug candidates in foreign markets, which may adversely affect our operating results and financial condition. Our therapeutic candidates will remain subject to ongoing regulatory requirements even if they receive marketing approval, and if we fail to comply with requirements, we could lose these approvals and the sale of any approved commercial products could be suspended. If we are unable to comply with applicable governmental regulations, we may not be able to continue our predictive and personalized medicine operations. Risks Related to Commercialization of Our Products and Product Candidates Our current predictive medicine products and other predictive and personalized medicine or therapeutic products that we may develop may never achieve significant commercial market acceptance. We may not be able to maintain or increase revenue growth and profitability for our predictive medicine products. We rely on a single laboratory facility to process our predictive medicine tests. If we do not compete effectively with scientific and commercial competitors, we may not be able to successfully commercialize our products. If we are unable to maintain relationships with current collaborative partners or enter into new collaborative arrangements, then our business could be harmed. If our current research collaborators or scientific advisors terminate their relationships with us or develop relationships with a competitor, our ability to discover genes, proteins and drug targets, and to commercialize therapeutic and predictive medicine products could be adversely affected. If we fail to retain our key personnel and hire, train and retain qualified employees and consultants, we may not be able to successfully continue our business. We have no experience manufacturing therapeutic products, and we currently intend to rely on third-party manufacturers to manufacture such products for us. We have limited sales, marketing and distribution capabilities, and with respect to our potential therapeutic products, we may be dependent on third parties to successfully perform these functions on our behalf, or we may be required to incur significant costs and devote significant efforts to augment our existing capabilities. We depend on a limited number of third parties for some of our supplies of equipment and reagents. If these supplies become unavailable, then we may not be able to successfully perform our research or operate our business at all or on a timely basis. If the government and third-party payors fail to provide coverage and adequate payment rates for our products and future products, if any, our revenue and prospects for profitability will be harmed. Risks Related to Our Intellectual Property We may be unable to adequately prevent disclosure of trade secrets and other proprietary information. If we are not able to protect our proprietary technology, others could compete against us more directly, which would harm our business. If we were sued for patent infringement by third parties, we might incur significant costs and delays in product introduction. We may be subject to claims that we or our employees have wrongfully used or disclosed alleged trade secrets of their former employers. Risks Related to Our Common Stock Our stock price is highly volatile, and our stock may lose all or a significant part of its value. Anti-takeover provisions of Delaware law, provisions in our charter and bylaws and our stockholders rights plan, or poison pill, could make a third-party acquisition of us difficult.

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899923--9/7/2006--MYRIAD_GENETICS_INC