Hospira withdraws 2013 guidance after FDA expands Symbiq alert

theflyonthewall.com

Hospira (HSP) disclosed in a regulatory filing that the company is withdrawing the 2013 full-year financial projections communicated during its earnings call on February 13 after it received written notification from the U.S. Food and Drug Administration that the FDA had expanded the Symbiq import alert issued on November 8, 2012. That alert prohibited the importation of Symbiq infusion pumps into the U.S. and the expansion received on February 13 prohibits the importation into the U.S. of the Plum, GemStar, and LifeCare PCA infusion pumps which are manufactured in its Costa Rica facility, the company said. The FDA’s import alert does not restrict importation of the Company’s consumables and other infusion pump accessories. Assuming that the import ban on Plum, GemStar, and LifeCare PCA remains in effect throughout 2013, the company’s preliminary estimate is that the impact for this matter could be in the range of $50M-$100M in decreased net sales and 10c-20c reduction in U.S. GAAP earnings per share or an adjusted earnings per share impact of 5c-15c. The company said it will be refining these estimates, aggressively evaluating potential mitigation strategies, and plans on issuing new guidance at its Q1 earnings call.

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