1323854--3/1/2010--Warner_Chilcott

related topics

{product, liability, claim}

{regulation, government, change}

{regulation, change, law}

{financial, litigation, operation}

{stock, price, share}

{acquisition, growth, future}

{product, market, service}

{product, candidate, development}

{gas, price, oil}

{stock, price, operating}

{operation, natural, condition}

{provision, law, control}

{tax, income, asset}

{debt, indebtedness, cash}

{property, intellectual, protect}

{personnel, key, retain}

{customer, product, revenue}

{interest, director, officer}

Special Note Regarding Forward-Looking Statements Risks Relating to Our Business If generic products that compete with any of our branded pharmaceutical products are approved and sold, sales of our products will be adversely affected. Our trademarks, patents and other intellectual property are valuable assets, and if we are unable to protect them from infringement or challenges, our business prospects may be harmed. Delays in production could have a material adverse impact on our business. Pricing pressures from third-party payors, including managed care organizations, government sponsored health systems and regulations relating to Medicare and Medicaid, healthcare reform, pharmaceutical reimbursement and pricing in general could decrease our U.S. revenues. Government regulation in the European Union of the price and reimbursement status of medicinal products could limit market acceptance of our products or reduce the prices we receive for our products. Taxing authorities could reallocate our taxable income among our subsidiaries, which could increase our consolidated tax liability, and changes in tax laws and regulations could materially adversely affect our results of operations, financial position and cash flows. Changes in market conditions, including lower than expected cash flows or revenues for our branded pharmaceutical products as a result of competition from other branded products, may result in our inability to realize the value of our products, in which case we may have to record an impairment charge. Recent legal and regulatory requirements could make it more difficult for us to obtain new or expanded approvals for our products, and could limit or make more burdensome our ability to commercialize our approved products. Delays and uncertainties in clinical trials or the government approval process for new products could result in lost market opportunities and hamper our ability to recoup costs associated with product development. Changes in laws and regulations could adversely affect our results of operations, financial position or cash flows. The perceived health effects of estrogen and combined estrogen-progestogen hormone therapy, or HT, products may affect the acceptability and commercial success of our HT products. The loss of the services of members of our senior management team or scientific staff or the inability to attract and retain other highly qualified employees could impede our ability to meet our strategic objectives and adversely affect our business. Product liability claims and product recalls could harm our business. Sales of our products may be adversely affected by the consolidation among wholesale drug distributors and the growth of large retail drug store chains. If we fail to comply with government regulations we could be subject to fines, sanctions and penalties that could adversely affect our ability to operate our business. We may not be able to successfully identify, develop, acquire, license or market new products as part of growing our business. Prescription drug importation from Canada and other countries could increase pricing pressure on certain of our products and could decrease our revenues and profit margins. We have a significant amount of intangible assets, which may never generate the returns we expect. If we fail to comply with our reporting and payment obligations under the Medicaid rebate program or other governmental pricing programs, we could be subject to additional reimbursements, penalties, sanctions and fines which could have a material adverse effect on our business. Adverse outcomes in our outstanding litigation matters, or in new litigation matters that arise in the future, could negatively affect our business, results of operations, financial condition and cash flows. Risks Related to the PGP Acquisition We may not realize the anticipated opportunities from the PGP Acquisition. The PGP business faces business, regulatory and other risks, some of which may be different from the risks we currently face. We have a substantial amount of indebtedness following the PGP Acquisition, which may adversely affect our cash flow and our ability to operate our business, remain in compliance with debt covenants and make payments on our indebtedness. Risks Relating to Our Ordinary Shares Future sales of our shares could depress the market price of our ordinary shares. The market price of our ordinary shares may be volatile, which could cause the value of your investment to decline significantly. Provisions of our articles of association could delay or prevent a takeover of us by a third party. Because our Sponsors own a substantial portion of our outstanding ordinary shares, if they act collectively, the influence of our public shareholders over significant corporate actions may be limited, and conflicts of interest between our Sponsors and us or you could arise in the future. We are incorporated in Ireland, and Irish law differs from the laws in effect in the United States and may afford less protection to shareholders. We are an Irish company and it may be difficult for you to enforce judgments against us.

Full 10-K form ▸

1323854--3/1/2010--Warner_Chilcott_plc