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related topics |
{product, candidate, development} |
{product, liability, claim} |
{customer, product, revenue} |
{stock, price, share} |
{property, intellectual, protect} |
{personnel, key, retain} |
{regulation, change, law} |
{tax, income, asset} |
{product, market, service} |
{cost, operation, labor} |
{operation, international, foreign} |
{provision, law, control} |
{control, financial, internal} |
{debt, indebtedness, cash} |
{stock, price, operating} |
{regulation, government, change} |
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We have a history of losses and we may continue to incur losses.
Our business is heavily dependent on the continued sale of CRINONE
by our marketing partners. If revenues from these partnered products fail to increase as anticipated, or materially decline, our financial condition and results of operations will be materially harmed.
We acquired marketing rights to
in the United States in December 2006, and we may never realize the anticipated benefits of the acquisition.
Healthcare insurers and other payors may not pay for our products or may impose limits on reimbursement.
We face significant competition from pharmaceutical and consumer product companies, which may adversely impact our market share.
Our products could demonstrate hormone replacement risks.
We may be exposed to product liability claims.
Steps taken by us to protect our proprietary rights might not be adequate, in which case competitors may infringe on our rights or develop similar products.
The United States and foreign patents upon which our original Bioadhesive Delivery System was based have expired.
We are subject to government regulation, which could affect our ability to sell products.
The development of our pharmaceutical products is uncertain and subject to a number of significant risks.
We may experience adverse events in clinical trials, which could delay or halt our product development.
Delays or failures in obtaining regulatory approvals may delay or prevent marketing of the products that we are developing.
We are dependent on third-party suppliers of raw materials for our products, the loss of whom could impair our ability to manufacture and sell our products.
We are dependent upon third-party developers and manufacturers, the loss of which could result in a loss of revenues.
The loss of our key executives could have a significant impact on our company.
We may be limited in our use of our net operating loss carryforwards.
The price of our Common Stock has been and may continue to be volatile.
Sales of large amounts of Common Stock may adversely affect our market price.
The issuance of preferred stock or convertible debt may adversely affect rights of common stockholders.
We have a substantial amount of debt.
Our corporate compliance program cannot guarantee that we are in compliance with all potentially applicable regulations.
We could be negatively impacted by future interpretation or implementation of federal and state fraud and abuse laws, including anti-kickback laws, false claims laws and federal and state anti-referral laws.
Anti-takeover provisions could impede or discourage a third-party acquisition of our company. This could prevent stockholders from receiving a premium over market price for their stock.
We are exposed to market risk from foreign currency exchange rates.
Full 10-K form ▸
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