1105184--2/26/2009--NANOSPHERE

related topics

{stock, price, operating}

{product, candidate, development}

{product, liability, claim}

{property, intellectual, protect}

{product, market, service}

{capital, credit, financial}

{stock, price, share}

{cost, operation, labor}

{control, financial, internal}

{provision, law, control}

{personnel, key, retain}

{cost, regulation, environmental}

{regulation, government, change}

If third-party payors do not reimburse our customers for the use of our clinical diagnostic products or if they reduce reimbursement levels, our ability to sell our products will be harmed. We may fail to receive positive clinical results from the diagnostic tests currently in development that require clinical trials, and even if we receive positive clinical results, we may still fail to receive the necessary clearances or approvals to market our products. Our operating results may be variable and unpredictable. If we do not achieve significant product revenue, we may not be able to meet our cash requirements without obtaining additional capital from external sources, and if we are unable to do so, we may have to curtail or cease operations. The adverse capital and credit market conditions could affect our liquidity. If our products do not perform as expected or the reliability of the technology on which our products are based is questioned, we could experience lost revenue, delayed or reduced market acceptance of our products, increased costs and damage to our reputation. We rely on third-party license agreements for patents and other technology related to our products, and the termination of these agreements could delay or prevent us from being able to commercialize our products. If we are unable to obtain, maintain and enforce intellectual property protection covering our products, others may be able to make, use, or sell our products, which could adversely affect our ability to compete in the market. Our products could infringe patent rights of others, which may require costly litigation and, if we are not successful, could cause us to pay substantial damages or limit our ability to commercialize our products. We have limited experience in sales and marketing and may be unable to successfully commercialize our Verigene System, or it may be difficult to build brand loyalty. We may be unsuccessful in our long-term goal of expanding our product offerings outside the United States. Manufacturing risks and inefficiencies may adversely affect our ability to produce products. We will need to develop manufacturing capacity by ourselves or with third parties. Our business and future operating results may be adversely affected by events outside of our control. We face intense competition from established and new companies in the molecular diagnostics field. Our success may depend upon how we and our competitors anticipate and adapt to market conditions. We may not be able to manage our anticipated growth, and we may experience constraints or inefficiencies caused by unanticipated acceleration and deceleration of customer demand. We use hazardous chemicals, biological materials, and infectious diseases in our business. Any claims relating to improper handling, storage or disposal of these materials could be time consuming and costly. If we are unable to recruit and retain key executives and scientists, we may be unable to achieve our goals. Healthcare reform and restrictions on reimbursement may adversely affect our profitability. Risks Related to Our Common Stock The market price of our common stock may be volatile and fluctuate significantly, which could result in substantial losses for investors and subject us to securities class action litigation. If equity research analysts do not publish research or reports about our business or if they issue unfavorable commentary or downgrade our common stock, the price of our common stock could decline. Certain provisions of our corporate governing documents could make an acquisition of our company more difficult. We do not currently intend to pay dividends on our capital stock and, consequently, your ability to achieve a return on your investment will depend on appreciation in the price of our common stock. We will continue to incur costs and demands upon management as a result of complying with the laws and regulations affecting public companies, which may adversely affect our operating results and failure to achieve and maintain effective internal controls in accordance with Section 404 of the Sarbanes-Oxley Act could cause investors to lose confidence in our operating results and in the accuracy of our financial reports and could have a material adverse effect on our business and on the price of our common stock. Concentration of ownership among some of our stockholders, including directors and management may limit your ability to influence corporate matters.

Full 10-K form ▸

1105184--2/26/2009--NANOSPHERE_INC