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related topics |
{product, candidate, development} |
{product, liability, claim} |
{stock, price, operating} |
{cost, regulation, environmental} |
{control, financial, internal} |
{property, intellectual, protect} |
{stock, price, share} |
{provision, law, control} |
{system, service, information} |
{personnel, key, retain} |
{cost, operation, labor} |
{competitive, industry, competition} |
{acquisition, growth, future} |
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Risks Relating to Our Business
We have incurred substantial losses since our inception in 1986, expect to
continue to incur such losses, and may never be profitable.
If we fail to obtain additional financing, we may be unable to complete the
development and commercialization of our product candidates or continue our
If we fail to establish collaborative relationships to commercialize certain of our drug product candidates or if any collaborator terminates or fails to perform its obligations under agreements with us, the commercialization of our product candidates could be delayed or terminated.
We have not commercialized any products or technologies and our future revenue
If our development collaborations with other parties fail, the development of
our drug product candidates will be delayed or stopped.
Our development of both intravenous and intramuscular dosing of peramivir for avian flu is subject to all disclosed drug development and potential commercialization risks and numerous additional risks. Any potential revenue benefits to us are highly speculative.
Because we have limited manufacturing experience, we depend on third-party manufacturers to manufacture our drug product candidates and the materials for our product candidates. If we cannot rely on third-party manufacturers, we will be required to incur significant costs and potential delays in finding new third-party manufacturers.
We may be unable to establish sales, marketing and distribution capabilities
necessary to successfully commercialize products we may successfully develop.
If the clinical trials of our drug product candidates fail, our product candidates will
not be marketed, which would result in a complete absence of product related
If we or our licensees do not obtain and maintain governmental approvals for
our products under development, we or our partners will not be able to sell
these potential products, which would significantly harm our business because
we will receive no revenue.
If our drug product candidates do not achieve broad market acceptance, our business may
We face intense competition, and if we are unable to compete effectively, the
demand for our products, if any, may be reduced.
If we fail to adequately protect or enforce our intellectual property rights or
secure rights to patents of others, the value of those rights would diminish.
If we fail to retain our existing key personnel or fail to attract and retain
additional key personnel, the development of our drug product candidates and the
expansion of our business will be delayed or stopped.
If users of our drug products are not reimbursed for use, future sales of our
The Medicare prescription drug coverage legislation and future legislative or regulatory reform of the healthcare system may affect our ability to sell our products profitably.
There is a substantial risk of product liability claims in our business. If we are unable to obtain sufficient insurance, a product liability claim against us could adversely affect our business.
If our computer systems fail or our facility incurs damage, our business will suffer.
If, because of our use of hazardous materials, we violate any environmental
controls or regulations that apply to such materials, we may incur substantial
costs and expenses in our remediation efforts.
Risks Relating to Our Common Stock
Our stock price is likely to be highly volatile and the value of your
Because stock ownership is concentrated, you and other investors will have
limited influence on stockholder decisions.
We have anti-takeover provisions in our corporate charter documents that may
result in outcomes with which you do not agree.
We have never paid dividends on our common stock and do not anticipate doing so
Full 10-K form ▸
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