350907--2/24/2010--THORATEC

related topics

{product, liability, claim}

{customer, product, revenue}

{regulation, change, law}

{product, market, service}

{debt, indebtedness, cash}

{cost, regulation, environmental}

{acquisition, growth, future}

{operation, international, foreign}

{product, candidate, development}

{control, financial, internal}

{tax, income, asset}

{stock, price, share}

{gas, price, oil}

{stock, price, operating}

{personnel, key, retain}

{operation, natural, condition}

{property, intellectual, protect}

{condition, economic, financial}

If we fail to obtain approval from the FDA and from foreign regulatory authorities, we cannot market and sell our products under development in the U.S. and in other countries, and if we fail to comply with government regulations, including FDA Quality System Regulations, or our products experience certain adverse events, the FDA or foreign regulatory authorities may withdraw our market clearance or take other enforcement action. If hospitals do not conduct Destination Therapy procedures using our VADs, market opportunities for our product will be diminished. Physicians may not accept or continue to accept our current products and products under development. We rely on specialized suppliers for certain components and materials in our products and alternative suppliers may not be available. We may encounter problems manufacturing our products. Identified quality problems can result in substantial costs and write-downs. If we fail to successfully introduce new products, our future growth may suffer. If we are unable to successfully complete the pre-clinical studies or clinical trials necessary to support our PMA applications or PMA supplements, our ability to obtain new approvals will be limited. Our inability to protect our proprietary technologies or an infringement of others patents could harm our competitive position. Our future disposable cuvette test product sales by ITC could be affected by changes in monitoring requirements for medical procedures. Since we depend upon distributors, if we lose a distributor or a distributor fails to perform, our operations may be harmed. If we fail to compete successfully against our existing or potential competitors, our product sales or operating results may be harmed. Our non-U.S. sales present special risks. Fluctuations in foreign currency exchange rates could result in declines in our reported sales and earnings. The long and variable sales and deployment cycles for our VAD systems may cause our product sales and operating results to vary significantly, which increases the risk of an operating loss for any given fiscal period. Since our physician and hospital customers depend on third party reimbursement, if third party payors fail to provide appropriate levels of reimbursement for our products, our results of operations will be harmed. Complying with federal and state regulations is an expensive and time-consuming process, and any failure to comply could result in substantial penalties. We depend on HeartMate II for a significant portion of our Cardiovascular division revenues. Federal and state anti-kickback laws may adversely affect our operations and income. Our debt obligations expose us to risks that could adversely affect our business, operating results and financial condition. We may be unable to repay or repurchase our senior subordinated convertible notes or our other indebtedness. Conversion of the senior subordinated convertible notes or other future issuances of our stock will dilute the ownership interests of existing shareholders. Amortization of our intangible assets, which represent a significant portion of our total assets, will adversely affect our net income and we may never realize the full value of our intangible assets. Product liability claims could damage our reputation and hurt our financial results. The competition for qualified personnel is particularly intense in our industry. If we are unable to retain or hire key personnel, we may not be able to sustain or grow our business. The price of our common stock may fluctuate significantly. Current global economic conditions could harm our business and liquidity. If we make acquisitions or divestitures, we could encounter difficulties that harm our business. The occurrence of a catastrophic disaster or other similar events could cause damage to our facilities and equipment, which would require us to cease or curtail operations. We have a history of net losses. We have experienced rapid growth and changes in our business, and our failure to manage this and any future growth could harm our business. Revisions to accounting standards, financial reporting and corporate governance requirements and tax laws could result in changes to our standard practices and could require a significant expenditure of time, attention and resources, especially by senior management. We are subject to taxation in a number of jurisdictions and changes to the corporate tax rate and laws of any of these jurisdictions could increase the amount of corporate taxes we have to pay. Any claims relating to improper handling, storage or disposal of hazardous chemicals and biomaterials could be time consuming and costly.

Full 10-K form ▸

350907--2/24/2010--THORATEC_CORP