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related topics |
{product, liability, claim} |
{customer, product, revenue} |
{operation, international, foreign} |
{product, market, service} |
{property, intellectual, protect} |
{stock, price, operating} |
{personnel, key, retain} |
{acquisition, growth, future} |
{cost, contract, operation} |
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Our biologics business is subject to emerging governmental regulations that can significantly impact our business
Modifications to our marketed devices may require FDA regulatory clearances or approvals or require us to cease marketing or recall the modified devices until such clearances or approvals are obtained
If we lose one of our key suppliers, we may be unable to meet customer orders for our products in a timely manner or within our budget
If we fail to compete successfully in the future against our existing or potential competitors, our sales and operating results may be negatively affected and we may not achieve future growth
If we are unable to continue to develop and market new products and technologies, we may experience a decrease in demand for our products or our products could become obsolete, and our business would suffer
If our patents and other intellectual property rights do not adequately protect our products, we may lose market share to our competitors and be unable to operate our business profitably
If we lose any existing or future intellectual property lawsuits, a court could require us to pay significant damages or prevent us from selling our products
If product liability lawsuits are brought against us, our business may be harmed
Fluctuations in insurance expense could adversely affect our profitability
If we cannot retain our key personnel, we will not be able to manage and operate successfully and we may not be able to meet our strategic objectives
We derive a significant portion of our sales from operations in international markets that are subject to political, economic and social instability
Our business could suffer if the medical community does not continue to accept allograft technology
If adequate levels of reimbursement from third-party payors for our products are not obtained, surgeons and patients may be reluctant to use our products and our sales may decline
If market clearance is not obtained for the re-launch of the ADCON
Gel products and the launch of the CONSERVE
Plus implant in the U.S., growth of our biologics and hip product lines could be impacted
If surgeons do not recommend and endorse our products, our sales may decline or we may be unable to increase our sales and profits
If a natural or man-made disaster strikes our manufacturing facilities, we could be unable to manufacture our products for a substantial amount of time and our sales could decline
Our business plan relies on certain assumptions about the market for our products, which, if incorrect, may adversely affect our profitability
Fluctuations in foreign currency exchange rates could result in declines in our reported sales and earnings
Efforts to acquire and integrate other companies or product lines could adversely affect our operations and financial results
Our quarterly operating results are subject to substantial fluctuations and you should not rely on them as an indication of our future results
Full 10-K form ▸
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