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{product, liability, claim} |
{product, candidate, development} |
{acquisition, growth, future} |
{customer, product, revenue} |
{stock, price, operating} |
{regulation, change, law} |
{personnel, key, retain} |
{cost, regulation, environmental} |
{property, intellectual, protect} |
{loan, real, estate} |
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We are highly dependent on the success of our key product candidate, ferumoxytol.
We may never receive regulatory approval for the marketing and commercial sale of ferumoxytol or may experience significant delays in our efforts to obtain approval for ferumoxytol.
Ferumoxytol's approved indication may be more restrictive than proposed in our application to the FDA, which would adversely impact our ability to generate revenues from sales of ferumoxytol.
Ferumoxytol, even if approved, will remain subject to ongoing regulatory review, and if we fail to comply with such continuing regulations we could be subject to penalties up to and including the suspension of the manufacturing, marketing and sale of ferumoxytol.
Significant safety or drug interaction problems could arise for ferumoxytol even after FDA approval, resulting in recalls, restrictions in ferumoxytol's label, or withdrawal of ferumoxytol from the market.
Our ability to generate and grow revenues from the commercialization and sale of ferumoxytol will be limited if we do not obtain approval to market ferumoxytol for additional indications in the U.S. or if we do not obtain approval to market ferumoxytol in additional countries.
Our ability to generate future revenues from ferumoxytol will depend heavily on our ability to obtain satisfactory coverage, reimbursement and pricing for ferumoxytol.
The investment of our cash and our short-term investments is subject to risks which may cause losses or adversely affect the liquidity of these investments.
Our corporate compliance program cannot ensure that we are in compliance with all applicable "fraud and abuse" laws and regulations, and our failure to comply with such laws and regulations could harm our business.
Legislative or regulatory changes may adversely impact our business.
We have limited marketing and sales experience.
The commercial success of ferumoxytol will depend upon the degree of market acceptance among physicians, patients, healthcare payors, and the two major operators of dialysis clinics in the U.S.
Competition in the pharmaceutical and biopharmaceutical industries is intense. If our competitors are able to develop and market products that are more effective, safer, less expensive or more convenient than ferumoxytol, our commercial opportunity for ferumoxytol will be reduced or eliminated.
Our inability to obtain raw materials and our reliance on sole source suppliers could adversely impact our ability to manufacture sufficient quantities of ferumoxytol, which would have a severe adverse impact on our business.
We need to maintain, and possibly increase, our manufacturing capabilities or establish and qualify a second source manufacturing facility in order to successfully commercialize ferumoxytol.
We may be unable to address the issues raised by the FDA in the March 2005 approvable letter with respect to Combidex, and we may not be able to obtain FDA approval for Combidex.
Our operating results will likely fluctuate so you should not rely on the results of any single quarter to predict how we will perform over time.
Our success depends on our ability to attract and retain key employees.
If we do not effectively manage our growth, our ability to commercialize ferumoxytol, pursue opportunities and expand our business could be adversely affected.
We may enter into collaborations, in-licensing arrangements, or acquisition agreements that could decrease our profitability, result in dilution to stockholders or cause us to incur debt or significant additional expense.
We may need additional capital to achieve our business objectives.
Our success depends on our ability to maintain the proprietary nature of our technology.
We are exposed to potential liability claims and we may not be able to maintain or obtain sufficient insurance coverage.
We are subject to environmental laws and potential exposure to environmental liabilities.
Our stock price has been and may continue to be volatile, and your investment in our stock could decline in value or fluctuate significantly.
If securities analysts downgrade our stock or cease coverage of us, the price of our stock could decline.
Full 10-K form ▸
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