Genzyme’s fourth-quarter non-GAAP diluted earnings per share (EPS) is expected to be $0.80 – $0.85, approximately double the third quarter non-GAAP diluted EPS of $0.42. Fourth-quarter non-GAAP diluted EPS guidance was $0.90 – $0.95. Cerezyme revenue for the quarter was lower than anticipated and gross margins were reduced due to costs associated with manufacturing operation improvements. Cerezyme revenue was impacted by the delay of orders in Brazil; a late lot release that was exacerbated by shipping delays due to December weather issues in Europe; and the loss of a specific lot for Japan. Manufacturing operation costs were impacted by consent decree compliance measures, and expenses associated with the simultaneous start-up of three operations: the new Framingham plant, the fill/finish expansion in Waterford, and the transfer of fill/finish work to a third-party manufacturer.
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