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| related topics |
| {product, market, service} |
| {product, liability, claim} |
| {product, candidate, development} |
| {customer, product, revenue} |
| {tax, income, asset} |
| {operation, international, foreign} |
| {property, intellectual, protect} |
| {cost, contract, operation} |
| {cost, operation, labor} |
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We are dependent on the market acceptance of our existing products and products under development for revenue growth and profitability.
Competition and technological change in the diagnostic testing market may make our products less attractive or obsolete.
Manufacturing risks and inefficiencies may adversely affect our ability to produce products and could reduce our gross margins and increase our research and development expenses
We may be unable to accurately predict future sales through our distributors, which could harm our ability to efficiently manage our internal resources to match market demand.
Because we export our products to foreign countries, we are also subject to applicable regulatory approval requirements in those countries, which may impose additional costs upon us or prevent or delay us from marketing our products in those countries.
We are subject to ongoing regulation of the products for which we have obtained regulatory clearance or approval, among other things, which may result in significant costs or in certain circumstances, the suspension or withdrawal of previously obtained clearances or approvals.
We are dependent on sole-source suppliers for our products. A supply interruption would harm us.
Legal proceedings to obtain patents and litigation of third-party claims of intellectual property infringement or relating to existing licenses could require us to spend substantial amounts of money and could impair our operations.
Our international sales and operations may be harmed by political, social or economic changes, or by other factors.
Changing facilities costs and other risks relating to our move to our new corporate complex may negatively impact our operating results.
Long-lived and intangible assets may become impaired and result in an impairment charge.
We are dependent on others for the development of products. The failure of our collaborations to successfully develop products would harm our business.
We may have significant clinical and product liability exposure.
Full 10-K form ▸
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