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Amylin Pharmaceuticals Reports 2008 Financial Results
Date:1/27/2009

The Company's results for the quarter ended December 31, 2008 include a charge of $54.9 million associated with the Company's restructuring. This charge consists primarily of one-time expenses related to facility leases, including impairments of related tenant improvements and employee termination benefits. Net loss excluding this charge was $49.1 million, or $0.36 per share. Non-GAAP operating loss, excluding non-cash items and the restructuring charge, was $20.2 million for the quarter ended December 31, 2008 compared to $47.0 million for the same period in 2007. Including the restructuring charge, GAAP net loss was $104.1 million, or $0.76 per share, for the quarter ended December 31, 2008, compared to $76.9 million, or $0.57 per share, for the same period in 2007.

Fourth quarter highlights

Highlights of Amylin's fourth quarter and recent activities include:

BYETTA

  • Communicated the addition of BYETTA to the American Diabetes Association's treatment guidelines for the medical management of type 2 diabetes.

Exenatide Once Weekly

  • Announced that the ongoing extension of the DURATION-1 study is appropriate to use as the basis for demonstrating comparability between intermediate-scale clinical trial material made in Alkermes' manufacturing facility, and commercial-scale drug product made at Amylin's manufacturing facility based on feedback from the U.S. Food and Drug Administration (FDA).
  • Reaffirmed plans for exenatide once weekly NDA submission to the FDA by the end of the first half of 2009.
  • Completed enrollment of DURATION-3, the third in a planned program of superiority clinical studies of exenatide once weekly, comparing exenatide once weekly to insulin glargine in patients using oral diabetes medications. Results from this study are expected in the t
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SOURCE Amylin Pharmaceuticals, Inc.
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