859737--11/24/2010--HOLOGIC

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Risks Related to our Business The continuing worldwide macroeconomic uncertainty may adversely affect our business and prospects. Sales and market acceptance of our products is dependent upon the coverage and reimbursement decisions made by third party payors. The failure of third party payors to provide appropriate levels of coverage and reimbursement for the use of our products and treatments facilitated by our products could harm our business and prospects. The adoption of healthcare reform in the United States and the uncertainty surrounding the implementation of these reforms could harm our business and prospects. Changes in laws affecting the healthcare industry could adversely affect our revenues and profitability. Guidelines, recommendations and studies published by various organizations can reduce the use of our products. Our long-term success will depend upon our ability to successfully develop and commercialize new products and treatments and enhance our existing products and treatments. If we fail to achieve and maintain the high manufacturing standards that our products require, we may not be successful in developing and marketing those products. Our business could be harmed if products contain undetected errors or defects or do not meet customer specifications. Our products may be subject to recalls even after receiving FDA clearance or approval, which could harm our business and prospects. Interruptions, delays, shutdowns or damage at our manufacturing facilities could harm our business. Our delay or inability to obtain any necessary United States or foreign regulatory clearances or approvals for our newly developed products and treatments or product enhancements could harm our business and prospects. The markets for our newly developed products and treatments and newly introduced enhancements to our existing products and treatments may not develop as expected. Our business may be harmed by recently completed acquisitions or acquisitions we may complete in the future. It may be difficult for us to implement our strategies for improving growth. Our inability to successfully identify and complete acquisitions or successfully integrate any new or previous acquisitions could have a material adverse effect on our business. We are dependent upon a relatively small number of large clinical laboratory customers in the United States for a significant portion of our sales of the ThinPrep System and our molecular diagnostic products. Our business could be harmed if we are unable to protect our proprietary technology. Our business could be harmed if we infringe upon the intellectual property rights of others. Our international operations and foreign acquisitions expose us to additional operational challenges that we might not otherwise face. We utilize distributors for a portion of our sales, the loss of which could harm our revenues in the territory serviced by these distributors. Fluctuations in the exchange rates of European currencies and the other foreign currencies in which we conduct our business, in relation to the U.S. dollar, could harm our business and prospects. We rely on one or only a limited number of suppliers for some key components or subassemblies for our products. This reliance could harm our business and prospects. We face intense competition from other companies and may not be able to compete successfully. Our success depends upon our ability to adapt to rapid changes in technology and customer requirements. Our results of operations are subject to significant quarterly variation. Recent changes to reclassify full-field digital mammography to permit 510(k) clearance could increase competition for our digital mammography products. Some of our activities may subject us to risks under federal and state laws prohibiting kickbacks and false or fraudulent claims. We are subject to the risk of product liability claims relating to our products. We use hazardous materials and products. Our future success depends on the continued services of key personnel. Our failure to manage current or future alliances or joint ventures effectively may harm our business and prospects. An adverse change in the projected cash flows from our business units or the business climate in which they operate, including the continuation of the current financial and economic downturn, could require us to incur an impairment charge which could have an adverse impact on our operating results. Our effective tax rate may fluctuate and we may incur obligations in tax jurisdictions in excess of amounts that have been accrued. Risks Related to our Indebtedness We have incurred significant indebtedness that limits our operating flexibility, and could adversely affect our operations and financial results and prevent us from fulfilling our obligations. We may not be able to generate sufficient cash flow to service all of our obligations. Risks Related to our Common Stock and Convertible Notes Future issuances of common stock and hedging activities may depress the trading price of our common stock and our convertible notes. Future sales of our common stock in the public market or the issuance of securities senior to our common stock could adversely affect the trading price of our common stock and the value of our convertible notes and our ability to raise funds in new securities offerings. Provisions in our charter and bylaws and our stockholder rights plan may have the effect of discouraging advantageous offers for our business or common stock and limit the price that investors might be willing to pay in the future for shares of our common stock. Our stock price is volatile. Conversion of our Convertible Notes will dilute the ownership interest of existing stockholders, including holders who had previously converted their notes.

Full 10-K form ▸

859737--11/24/2010--HOLOGIC_INC