Warner Chilcott Limited (NASDAQ:WCRX) – Threat of generics to key products anticipated to impact FY 2009 performance.
Warner Chilcott settled both Femcon and Loestrin 24 FE patent cases during the first quarter of FY 2009, with favorable terms for the company. Actavis Elizabeth LLC (Actavis) submitted an Abbreviated New Drug Application (ANDA) to the US Food and Drug Administration (FDA) for approval to manufacture and sell generic versions of DORYX 100 mg and 75 mg delayed-release tablets, while Impax Laboratories, Inc. submitted an ANDA for approval to manufacture and sell a generic version of Doryx 150 mg in 1Q 09. Approximately 50% of Warner Chilcott’s franchisees have switched to the new 150 mg dose, which has a patent listed in the FDA Orange Book. If generics of DORYX 100 mg and 75 mg or DORYX 150 mg delayed release tablets are launched, we expect sales growth to be negatively impacted. In January 2009, Warner Chilcott increased the price of its key products, such as Doryx 75 mg and 100 mg delayed release tablets and Femcon FE. We believe this decision will positively impact future revenue growth. Furthermore, greater acceptance of Taclonex, Leostrin 24 FE and other products is also expected to contribute to revenue growth in FY 2009. Warner Chilcott’s development pipeline is progressing with a low-dose oral contraceptive on track for 1H 09 filing. Moreover, the oral erectile dysfunction project is expected to start Phase III trials in late FY 2009. We believe the strong portfolio will support revenue growth over the long term. We expect improvement in adjusted EBITDA margin, reflecting Management’s expectation of lower Selling, General and Administrative (SG&A) expenses, as a percentage of revenues, in FY 2009. We expect operating and net margins to be negatively impacted by higher amortization expenses associated with intangible assets in FY 2009 (according to the 10-K for the period ending December 2008 filed by the company). Operating margin is expected to improve from FY 2010 onwards. The company continues to focus on reducing its outstanding debt by consistently using its Free Cash Flow (FCF), and we do not see this trend reversing anytime soon. Consequently, our overall outlook for the company remains broadly positive.
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