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Warner Chilcott Reports Operating Results For The Quarter And Year Ended December 31, 2012

Stocks in this article: WCRX

References in this press release to "cash net income" or "CNI" mean our GAAP net income adjusted for the after-tax effects of two non-cash items: amortization (including impairments, if any) of intangible assets and amortization (including write-offs, if any) of deferred loan costs related to our debt. Adjusted CNI represents CNI as further adjusted to exclude the impact, on an after-tax basis (as applicable), of the Western European restructuring, the repurposing of our Manati facility, a litigation-related charge, a gain relating to the reversal of a liability for contingent milestone payments and the income tax benefits related to the reversal of reserves associated with our entry into the APAs. Reconciliations from our reported results in accordance with Generally Accepted Accounting Principles in the U.S. ("GAAP") to CNI, adjusted CNI and adjusted earnings before interest, taxes, depreciation and amortization ("Adjusted EBITDA") for all periods presented are included in the tables at the end of this press release.

Recent Events

New Product Approval

On February 5, 2013, we announced that the U.S. Food and Drug Administration ("FDA") approved DELZICOL (mesalamine) 400 mg delayed-release capsules, our new mesalamine product indicated for the treatment of mildly to moderately active ulcerative colitis and for the maintenance of remission of ulcerative colitis. We anticipate that we will commercially launch DELZICOL in March 2013, and that DELZICOL will become the promotional priority for our gastroenterology sales force upon launch.

Advance Pricing Agreements

In December 2012, we signed two APAs with the IRS. The first APA specifies the agreed upon terms under which our U.S. entities are compensated for distribution and service transactions between our U.S. and non-U.S. entities for the calendar years 2011 through 2017. The second APA reflects our agreement with the IRS in respect of the transfer of certain intangible assets from one of our U.S. subsidiaries to our Puerto Rican subsidiary. The effects of the new APAs have been recorded in our financial statements for the quarter ended December 31, 2012, including $12 million of income tax benefits related to the reversal of reserves under Financial Accounting Standards Board Accounting Standards Codification Topic 740 "Income Taxes."

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