1082554--2/29/2008--UNITED_THERAPEUTICS

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Risks Related to Our Business We have a history of losses and may not continue to be profitable We rely heavily on sales of Remodulin to produce revenues. Most of our pharmaceutical products are in clinical development and may never generate profits. We may not successfully compete with established drugs, products and 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 will not reimburse patients for our drug products or if third-party payers limit the amount of reimbursement, our sales will suffer. The growth of our cardiac monitoring business is dependent upon physicians utilizing our services; if we fail to maintain our current level of physician utilization, our cardiac monitoring revenues may stagnate and our business could be adversely affected. Reimbursement for cardiac monitoring services by Medicare is highly regulated and subject to change and the operation of our call centers and monitoring facilities is subject to rules and regulations governing Independent Diagnostic Testing Facilities; failure to comply with these rules could prevent us from receiving reimbursement for our cardiac services from Medicare and some commercial payers. We rely on third parties to market, distribute and sell most of our products and those third parties may not perform. Our operations depend on compliance with complex FDA and comparable international regulations. Failure to obtain broad approvals on a timely basis or to achieve continued compliance could delay or halt commercialization of our products. 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 transitioned our manufacturing operations to a new location. We depend on third parties to formulate and manufacture our products and related devices. 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 are inadequate, our sales and profits could suffer or our competitors could force our products completely out of the market. Our success depends in large part on our ability to operate without infringing upon the patents or other proprietary rights of third parties. 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. 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. We may encounter substantial difficulties managing our growth. Our financial results may be impacted by future accounting rules. Risks Related to Our Common Stock The price of our common stock could be volatile and could decline. We may fail to meet third party projections for our revenue or profits. Future sales of shares of our common stock may depress our stock price. The fundamental change purchase feature of the Convertible Notes may delay or prevent an otherwise beneficial attempt to take over our company. 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. Provisions of Delaware law and our certificate of incorporation, by-laws, shareholder rights plan, and employment and licensing agreements could prevent or delay a change in control or change in management that could be beneficial to us and our public stockholders. Change in control restrictions in certain of our agreements could prevent or delay a change in control or change in management that could be beneficial to us and our public stockholders. Our existing directors and executive officers own a substantial block of our common 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--2/29/2008--UNITED_THERAPEUTICS_CORP