1082554--2/28/2007--UNITED_THERAPEUTICS

related topics

{product, candidate, development}

{stock, price, share}

{product, liability, claim}

{stock, price, operating}

{provision, law, control}

{regulation, change, law}

{debt, indebtedness, cash}

{gas, price, oil}

{personnel, key, retain}

{property, intellectual, protect}

{cost, regulation, environmental}

Risks Related to Our Business Actual consolidated revenues and net income may be different from published securities analyst projections. In addition, we have a history of losses and may not continue to be profitable. We may not successfully compete with established drugs and the companies that develop and market them. Discoveries or developments of new technologies by others may make our products obsolete or less useful. We are aware of investigational products being developed for the treatment of PAH with which our products may have to compete. If third-party payers will not reimburse patients for our drug products or if third-party payers limit the amount of reimbursement, our sales will suffer. We rely on third parties to develop, market, distribute and sell most of our products and those third parties may not perform. If we cannot maintain regulatory approvals for our products, we cannot sell those products and our revenues will suffer. Our products may not be commercially successful because physicians and patients may not accept them. Reports of side effects, such as sepsis, associated with intravenous Remodulin could cause physicians and patients to not accept Remodulin or to cease to use Remodulin in favor of alternative treatments. We have limited experience with production and manufacturing and depend on third parties, who may not perform, to synthesize and manufacture many of our products. If our products fail in clinical studies, we will not be able to obtain or maintain FDA and international approvals and will not be able to sell those products. Our corporate compliance program cannot guarantee that we are in compliance with all potentially applicable federal, state and international regulations. If the licenses, assignments and alliance agreements we depend on are breached or terminated, we would lose our right to develop and sell the products covered by the licenses, assignments and alliance agreements. Certain license and assignment agreements relating to our products may restrict our ability to develop products in certain countries and/or for particular diseases and impose other restrictions on our freedom to develop and market our products. If our, or our suppliers , patent and other intellectual property protection is inadequate, our sales and profits could suffer or competitors could force our products completely out of the market. If our highly qualified management and technical personnel leave us, our business may suffer. We may not have adequate insurance and may have substantial exposure to payment of product liability claims. We may not have, or may have to share rights to, future inventions arising from our license, assignment and alliance agreements and may lose potential profits or savings. If we need additional financing and cannot obtain it, product development and sales may be limited. Our activities involve hazardous materials, and improper handling of these materials could expose us to significant liabilities. Risks Related to Our Common Stock Our stock price could be volatile and could decline. Future sales of shares of our common stock may depress our stock price. The Convertible Note Purchase Call Option and call warrant transactions we entered into in connection with the sale of the Convertible Notes may affect the trading price of our common stock. The fundamental change purchase feature of the Convertible 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 and shareholder rights plan could prevent or delay a change of control or change in management that could be beneficial to us and our public stockholders. We will need cash to pay at least a portion of the conversion value of the Convertible Notes, as required by the indenture governing the notes. Our existing directors and executive officers own a substantial block of our stock and might be able to influence the outcome of matters requiring stockholder approval. If stockholders do not receive dividends, stockholders must rely on stock appreciation for any return on their investment in us.

Full 10-K form ▸

1082554--2/28/2007--UNITED_THERAPEUTICS_CORP