1158895--3/29/2010--LEMAITRE_VASCULAR_INC

related topics
{product, liability, claim}
{acquisition, growth, future}
{customer, product, revenue}
{property, intellectual, protect}
{operation, international, foreign}
{stock, price, operating}
{product, market, service}
{regulation, government, change}
{product, candidate, development}
{control, financial, internal}
{regulation, change, law}
{cost, regulation, environmental}
{provision, law, control}
{personnel, key, retain}
{condition, economic, financial}
{operation, natural, condition}
Risks Related to Our Business We may experience significant fluctuations in our quarterly and annual results. We may not maintain our recent profitability Fluctuations in foreign currency exchange rates could result in declines in our reported sales and earnings. We may acquire businesses and assets in the future. We may experience difficulties in completing the integration of these acquisitions into our business, or we may not realize the anticipated benefits of these acquisitions. If we are unable to expand our product offerings, we may not achieve our growth objectives and our results of operations could suffer. We face intense competition from other companies, technologies, and alternative medical procedures and we may not be able to compete effectively. If we fail to convert additional countries or products from distributor sales to direct sales, or encounter difficulties in effecting such conversions, our results of operations could suffer. Current economic instability may harm our operating results. If we are unable to increase our selling prices to customers, our rate of net sales growth might be reduced and our operating results could suffer. If there is a disruption in the supply of products that we distribute, or if our relationships with their manufacturers are impaired, our net sales and results of operations would be harmed. Some of our devices have been recently introduced into the market and may not achieve market acceptance, which could adversely affect our business. If we are unable to manage the anticipated growth of our business, our financial condition and operating results could be adversely affected. The risks inherent in operating internationally and the risks of selling and shipping our products and of purchasing our components and products internationally may adversely impact our net sales, results of operations, and financial condition. We depend on single- and limited-source suppliers for some of the components to our products, as well as for acquired products that have not been transitioned to in-house manufacture, and if any of those suppliers are unable or unwilling to supply them on acceptable terms, it could limit our ability to deliver our products to our customers on a timely basis or at all. Any disruption in our manufacturing facilities could harm our results of operations. Our primary focus on the needs of vascular surgeons could harm our business if interventional cardiologists and interventional radiologists perform a greater percentage of new procedures that replace those procedures traditionally performed by vascular surgeons, or if vascular surgeons increasingly specialize in procedures for which we do not sell devices. We depend on our senior management team and other key scientific, sales, and technical personnel, and if we are unable to retain them or recruit additional qualified personnel we may not be able to manage our operations and meet our strategic objectives. If we do not maintain our relationships with our physician customers, our growth may be limited and our business could be harmed. Our lack of customer purchase contracts makes it difficult to predict sales and plan manufacturing requirements, which could lead to lower net sales, higher expenses, and reduced margins. The use or misuse of our products may result in injuries that lead to product liability suits, which could be costly to our business. The adoption of healthcare reform in the United States may harm our business, results of operations and/or financial condition. We rely on our independent distributors to market and sell our products in select markets outside of the United States and Canada. We may not maintain positive cash flow from operations and, as a result, we may require additional capital. Failure to attract additional capital on acceptable terms could impair our growth. Our assumptions about the market for our products may not be correct. From time to time we may become subject to tax audits or similar proceedings, and as a result we may owe additional taxes, interest, and penalties in amounts that may be material. Risks Related to the Regulatory Environment Our business is subject to complex, costly, and burdensome regulations. We could be subject to significant penalties if we fail to comply. If we are not successful in obtaining and maintaining clearances and approvals from governmental agencies, we will not be able to sell our products, and our future growth will be significantly hampered. Modifications to our marketed devices may require new regulatory clearances or premarket approvals, or may require us to cease marketing or recall the modified devices until clearances or approvals are obtained. If we or some of our suppliers fail to comply with the FDA s Quality System Regulation and other applicable postmarket requirements, our manufacturing operations could be disrupted, our product sales and profitability could suffer, and we may become subject to a wide variety of FDA enforcement actions. Even after receiving regulatory clearance or approval, our products may be subject to product recalls, which may harm our reputation and divert managerial and financial resources. If we do not comply with foreign regulatory requirements to market our products outside the United States, our business will be harmed. If we fail to comply with healthcare regulations, we could face substantial penalties and our business, operations, and financial condition could be adversely affected. Compliance with environmental laws and regulations could be expensive. Failure to comply with environmental laws and regulations could subject us to significant liability. Inadequate levels of reimbursement from governmental or other third-party payors for procedures using our products may cause our net sales to decline. Risks Related to Intellectual Property If we fail to adequately protect our intellectual property rights, or prevent use of our intellectual property by third parties, we could lose a significant competitive advantage and our business may suffer. If third parties claim that we infringe upon their intellectual property rights, we may incur liabilities and costs, and we may have to redesign or discontinue selling the affected product. We may become involved in lawsuits and administrative proceedings to protect, defend, or enforce our patents that would be expensive and time consuming. If we fail to observe the terms of our agreements with third-party patent holders, we may lose the ability to manufacture, market, or sell some of our products. Risks Related to Our Common Stock Our stock price may be volatile, and your investment in our common stock could suffer a decline in value. Our directors, officers, and principal stockholders have significant voting power and may take actions that may not be in the best interests of our other stockholders. Future acquisitions that we make may be dilutive to our current stockholders. Our corporate documents and Delaware law contain provisions that could discourage, delay, or prevent a change in control of our company.

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