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{product, liability, claim} |
{product, candidate, development} |
{property, intellectual, protect} |
{personnel, key, retain} |
{stock, price, share} |
{stock, price, operating} |
{cost, regulation, environmental} |
{acquisition, growth, future} |
{customer, product, revenue} |
{gas, price, oil} |
{operation, international, foreign} |
{product, market, service} |
{regulation, government, change} |
{financial, litigation, operation} |
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Our revenue has been substantially dependent on our sole source distributor, ICS, and a limited number of domestic wholesalers and international distributors involved in the sale of our products, and such revenue may fluctuate from quarter to quarter based on the buying patterns of such distributor, wholesalers and distribution partners
Failure to achieve our revenue targets or raise additional funds in the future may require us to delay, reduce the scope of, or eliminate one or more of our planned activities
Angiomax competes with all categories of anticoagulant drugs, which may limit the use of Angiomax and adversely affect our revenue
Cleviprex competes with all categories of intravenous antihypertensive, or IV-AHT, drugs, which may limit the use of Cleviprex and adversely affect our revenue
We face substantial competition, which may result in others discovering, developing or commercializing competing products before or more successfully than we do
If physicians, patients and other key decision-makers do not accept clinical data from trials of Angiomax and Cleviprex, then sales of Angiomax and Cleviprex may be adversely affected
If the number of PCI procedures performed decreases, sales of Angiomax may be negatively impacted
If we are unable to successfully expand our business infrastructure and develop our global operations, our ability to generate future product revenue will be adversely affected
The success of our global operations may be adversely affected by international risks and uncertainties. If these operations are not successful, our results of operations and financial position could be adversely affected.
Our ability to generate future product revenue will be affected by reimbursement and drug pricing
If we do not comply with federal, state and foreign laws and regulations relating to the health care business, we could face substantial penalties
If we are unable to obtain insurance at acceptable costs and adequate levels or otherwise protect ourselves against potential product liability claims, we could be exposed to significant liability
Risks Related to Regulatory Matters
If we do not obtain regulatory approvals for our product candidates, we will not be able to market our product candidates and our ability to generate additional revenue could be materially impaired
We cannot expand the indications for which we are marketing Angiomax unless we receive regulatory approval for each additional indication. Failure to expand these indications will limit the size of the commercial market for Angiomax
Clinical trials of product candidates are expensive and time-consuming, and the results of these trials are uncertain
If we or our contract manufacturers fail to comply with the extensive regulatory requirements to which we, our contract manufacturers and our products are subject, our products could be subject to restrictions or withdrawal from the market and we could be subject to penalties
Risks Related to our Dependence on Third Parties for Manufacturing, Research and Development, and Distribution Activities
We depend on single source suppliers for the production of bulk drug substance for Angiomax, Cleviprex and our other products in development and a limited number of suppliers to carry out all fill-finish activities
If third parties on whom we rely to manufacture and support the development and commercialization of our products do not fulfill their obligations, the development and commercialization of our products may be terminated or delayed, and the costs of development and commercialization may increase.
Use of third-party manufacturers may increase the risk that we will not have appropriate supplies of our products or our product candidates
In order to satisfy some regulatory authorities, we may need to reformulate the way in which our oritavancin bulk drug substance is created to remove animal source product, which may delay marketing approval of our products and increase our costs
If we use hazardous and biological materials in a manner that causes injury or violates applicable law, we may be liable for damages
Risks Related to Our Intellectual Property
If we are unable to extend the patent term of the principal U.S. patent covering Angiomax or to maintain market exclusivity for Angiomax in the United States through the enforcement of our other U.S. patents covering Angiomax, then Angiomax could be subject to generic competition as early as September 2010. Generic competition for Angiomax would have an adverse effect on our business, financial condition and results of operations
If we breach any of the agreements under which we license rights to products or technology from others, we could lose license rights that are material to our business or be subject to claims by our licensors
If we are unable to obtain or maintain patent protection for the intellectual property relating to our products, the value of our products will be adversely affected
We may be unable to utilize the Chemilog process if Lonza Braine breaches our agreement
If we are not able to keep our trade secrets confidential, our technology and information may be used by others to compete against us
If we infringe or are alleged to infringe intellectual property rights of third parties, it will adversely affect our business
Risks Related to Growth and Employees
If we fail to acquire and develop additional product candidates or approved products it will impair our ability to grow
We may not be able to manage our business effectively if we are unable to attract and retain key personnel and consultants
Risks Related to Our Common Stock
Fluctuations in our operating results could affect the price of our common stock
Our stock price has been and may in the future be volatile. This volatility may make it difficult for you to sell common stock when you want or at attractive prices
Full 10-K form ▸
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