Android app on Google Play

Hospira (HSP) Withdrawing 2013 Guidance on Expanded FDA Symbi Import Alert

February 14, 2013 9:26 AM EST Send to a Friend
Hospira, Inc. (NYSE: HSP) is withdrawing the 2013 full-year financial projections after FDA expands Symbiq import alert.


On February 13, 2013, after issuing the fourth-quarter and full-year 2012 earnings release, filing the Form 10-K for the year ended December 31, 2012, and holding the related earnings conference call, Hospira, Inc. (“Company”) received written notification from the U.S. Food and Drug Administration (“FDA”) 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. The expansion received on February 13, 2013 prohibits the importation into the U.S. of the Plum™, GemStar™, and LifeCare PCA™ infusion pumps which are manufactured in our Costa Rica facility. The FDA’s import alert does not restrict importation of the Company’s consumables and other infusion pump accessories. The Company intends to support the repair and service of all impacted pumps to existing customers.

The Company is withdrawing the 2013 full-year financial projections communicated during the Company’s earnings call on February 13, 2013. 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 $50 to $100 million in decreased net sales and $0.10 to $0.20 reduction in U.S. GAAP earnings per share or an adjusted earnings per share impact of $0.05 to $0.15. The Company will be refining these estimates and aggressively evaluating potential mitigation strategies. The Company plans on issuing new guidance at its first quarter 2013 earnings call.

The Company takes this matter seriously. Any further actions by the FDA could have a material adverse impact on our financial position and operating results.




You May Also Be Interested In


Related Categories

Guidance, Hot Guidance

Related Entities

Earnings

Add Your Comment