936402--3/1/2006--Shire

related topics

{product, candidate, development}

{product, liability, claim}

{regulation, government, change}

{customer, product, revenue}

{gas, price, oil}

{system, service, information}

{property, intellectual, protect}

{personnel, key, retain}

{cost, regulation, environmental}

{acquisition, growth, future}

{stock, price, operating}

{product, market, service}

Any decrease in the sales of ADDERALL XR will significantly reduce revenues and earnings. Any decrease in the sales of 3TC could significantly reduce revenues and earnings. Future revenues from product sales will be impacted by the commercial success of the Company s new products. The introduction of new products by competitors may impact future revenues. The failure to obtain reimbursement, or an adequate level of reimbursement, by third-party payers in a timely manner for certain of the Company s products may impact future revenues. A disruption to the product supply chain may result in the Company being unable to continue marketing or developing a product or may result in the Company being unable to do so on a commercially viable basis. Fluctuations in wholesale buying patterns may influence net sales and growth comparisons. In the event of financial failure of certain customers, the Company may suffer financial loss and a decline in revenues. The actions of certain customers can affect the Company's ability to sell or market products profitably. The actions of governments, industry regulators and the economic environments in which it operates, may adversely affect the Company's ability to develop and market its products profitably. If the Company's projects or clinical trials for the development of products are unsuccessful, its products will not receive authorization for manufacture and sale. If the Company is unable to meet the requirements of regulators in relation to a particular product, it may be unable to develop the product or obtain or retain the necessary marketing approvals. The failure of a strategic partner to develop and commercialize products could result in delays in approval or loss of revenue. The failure to secure new products or compounds for development, either through in-licensing, acquisition or internal research and development efforts, may have an adverse impact on the Company's future results. The Company may fail to obtain, maintain, enforce or defend the intellectual property rights required to conduct its business. If a marketed product fails to work effectively or causes adverse side effects, this could result in damage to the Company's reputation, the withdrawal of the product and legal action against the Company. Monitoring or enforcement action by regulatory authorities or law enforcement agencies in the highly regulated markets in which the Company operates may result in the distraction of senior management, significant legal costs and the payment of substantial compensation or fines. The outsourcing of services can create a significant dependency on third parties, the failure of whom can affect the ability to operate the Company's business and to develop and market products. Loss of highly qualified management and scientific personnel could cause the Company subsequent financial loss. In the event of breakdown, failure or breach of security on any of the Company s IT systems, the Company may be unable to maintain its business operations. The Company may incur unexpected expenditure in order to comply with US environmental laws. Contracts are used in all areas of operation of the business. They may contain conditions that do not protect the Company's position or with which it cannot comply. The Company has recently completed the acquisition of TKT. If the Company fails to integrate this acquisition successfully, it may impact on the Company's future growth.

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936402--3/1/2006--Shire_plc