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related topics |
{product, candidate, development} |
{property, intellectual, protect} |
{product, liability, claim} |
{stock, price, share} |
{cost, regulation, environmental} |
{acquisition, growth, future} |
{regulation, government, change} |
{personnel, key, retain} |
{provision, law, control} |
{control, financial, internal} |
{stock, price, operating} |
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Risks Related to Our Business and Our Strategy
We may not be able to generate sufficient revenue from our existing products or develop new products to maintain profitability and may never achieve the goals of our business plan.
We have a history of operating losses.
If our current operating plan changes and we find that our existing capital resources will not meet our needs, we may find it necessary to raise additional funding, which may not be available.
If we do not continue to generate sufficient revenue from sales of our molecular diagnostic products and are unable to secure additional funding, we may have to reduce or discontinue operations.
If we were successfully sued for product liability, we could face substantial liabilities that exceed our resources.
Our business involves environmental risks that may result in liability for us.
Changes in healthcare policy could increase our costs, decrease our revenues and impact sales of and reimbursement for our tests.
If we are unable to comply with applicable governmental regulations, we may not be able to continue our operations.
Risks Related to Commercialization of Our Products and Product Candidates
We may not be able to maintain or increase revenue growth and profitability for our molecular diagnostic products.
If the government and third-party payors fail to provide coverage and adequate payment for our products and future products, if any, our revenue and prospects for profitability will be harmed.
We rely on a single laboratory facility to process our molecular diagnostic tests.
Our current molecular diagnostic product candidates in development may never achieve significant commercial market acceptance.
If we do not compete effectively with scientific and commercial competitors, we may not be able to successfully commercialize our products.
If our current research collaborators or scientific advisors terminate their relationships with us or develop relationships with a competitor, our ability to discover genes, proteins, and biomarkers, and to commercialize molecular diagnostic products could be adversely affected.
If we fail to retain our key personnel and hire, train and retain qualified employees and consultants, we may not be able to successfully continue our business.
As we expand our commercial products we may be required to incur significant costs and devote significant efforts to expand our existing products sales and marketing capabilities.
We depend on a limited number of third parties for some of our supplies of equipment and reagents. If these supplies become unavailable, then we may not be able to successfully perform our research or operate our business at all or on a timely basis.
Risks Related to Our Intellectual Property
If we fail to comply with our obligations under license or technology agreements with third parties, we could lose license rights that are critical to our business.
If we are not able to protect our proprietary technology, others could compete against us more directly, which would harm our business.
If we were sued for patent infringement by third parties, we might incur significant costs and delays in product introduction.
We may be unable to adequately prevent disclosure of trade secrets, proprietary databases, and other proprietary information.
We may be subject to claims that we or our employees have wrongfully used or disclosed alleged trade secrets of their former employers.
Risks Related to Our Common Stock
Our stock price is highly volatile, and our stock may lose all or a significant part of its value.
Anti-takeover provisions of Delaware law, provisions in our charter and bylaws and our stockholders rights plan, or poison pill, could make a third-party acquisition of us difficult.
Full 10-K form ▸
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