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Risks Related to Our Business
We have a history of losses and may not maintain profitability.
We rely heavily on sales of Remodulin and Tyvaso to produce revenues.
We may not compete successfully with established and newly developed drugs or products, or the companies that develop and market them.
Discoveries or development of new products or technologies by others may make our products obsolete or less useful.
If third-party payers do not reimburse our products, or if third-party payers reduce or limit reimbursements for our products, our sales will suffer.
We rely in part on third parties to perform activities that are critical to our business. Our ability to generate commercial sales or conduct clinical trials could suffer if our third-party suppliers and service providers fail to perform.
Our operations must comply with extensive FDA and comparable international regulations. Failure to obtain approvals on a timely basis or to achieve continued compliance could delay, disrupt or prevent the commercialization of our products.
Reports of side effects, such as sepsis, associated with intravenous Remodulin could cause physicians and patients to avoid or discontinue use of Remodulin in favor of alternative treatments.
If our products fail in clinical trials, we will be unable to obtain or maintain FDA and international regulatory approvals and will be unable to sell those products.
Our corporate compliance program cannot guarantee that we comply with all potentially applicable federal, state and international regulations.
If the licenses, assignments and alliance agreements we depend on are breached or terminated, we could lose our right to develop and sell products covered by such agreements.
Certain license and assignment agreements may restrict our ability to develop related products in certain countries and/or for particular diseases and may impose other restrictions on our freedom to develop and market our products.
If our or our suppliers' patents or other intellectual property protections are inadequate, our revenues and profits could suffer or our competitors could force our products out of the market.
We may not maintain adequate insurance coverage to protect us against significant product liability claims.
Our marketable investments may be subject to a loss in value and liquidity.
If we need additional financing and cannot obtain it, our product development and sales efforts may be limited.
Improper handling of hazardous materials used in our activities could expose us to significant liabilities.
We may encounter substantial difficulties managing our growth relative to product demand.
Our ability to recognize the full value of our business tax credits may be limited.
We have been named as a party to derivative lawsuits. Litigation proceedings are inherently uncertain and could result in an unfavorable outcome.
Risks Related to Our Common Stock
The price of our common stock can be highly volatile and may decline.
We may fail to meet third-party projections for our revenues or profits.
Sales of our common stock may depress our stock price.
The fundamental change purchase feature of the Convertible Senior Notes may delay or prevent an otherwise beneficial attempt to take over our company.
Provisions of Delaware law and our certificate of incorporation, by-laws, shareholder rights plan, and employment and license agreements could prevent or delay a change of control or change in management that may be beneficial to our public shareholders.
Our existing directors and executive officers own a substantial portion of our common stock and might be able to influence the outcome of matters requiring shareholder approval.
Because we do not intend to pay cash dividends, our shareholders must rely on stock appreciation for any return on their investment in us.
Full 10-K form ▸
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