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Integra LifeSciences Holdings Corporation today announced it expects total revenues in the fourth quarter to be approximately $202 million to $203 million. These fourth quarter 2011 revenues are approximately 3% below the low end of previously issued guidance. The revenue shortfall resulted from inventory reduction initiatives by our instruments distributors, weakness outside of the U.S., and weaker than expected sales of our domestic Extremity Reconstruction products.
The Company expects adjusted diluted earnings per share to be in the range of $0.65 to $0.70 for the fourth quarter of 2011, and between $2.74 to $2.79 for the full year 2011. Estimates of the adjustments to income before taxes are set forth in the table at the end of this press release.
The Company expects GAAP diluted earnings per share to be in the range of $0.08 to $0.20 for the fourth quarter of 2011, and between $0.87 and $0.99 for the full year 2011. The Company now estimates that its 2012 revenue will increase approximately 8% on a constant currency basis and 7% on a reported basis over final 2011 revenues and its adjusted earnings per share will increase approximately 8-9% over final 2011 results. The Company expects GAAP earnings per share to increase significantly more over final 2011 results. The reduced expectations for revenue and earnings in 2012 are the result of the soft performance in the fourth quarter of 2011, a stronger dollar compared to the Euro, international economic risk, and slightly lower growth expectations for the domestic extremity product lines.
The tax rates and other preliminary information are subject to change. "We are disappointed by our forecasting and execution in specific areas and have plans in place to address these issues," said Peter Arduini, Integra's President and Chief Executive Officer. "Despite these challenges in the fourth quarter, Integra accomplished a lot in 2011 that further positions the Company for future success."
The Company has scheduled a conference call for analysts and investors at 8:30 a.m., Friday, January 6, 2012, to discuss the preliminary results for 2011 and the preliminary expectations for 2012 and to answer questions. Further information about the call appears at the end of this press release.
Update on Plainsboro Manufacturing Facility
Integra also announced that it received a warning letter from the United States Food and Drug Administration (FDA) related to quality systems and compliance issues at its collagen manufacturing facility located in Plainsboro, New Jersey. The letter resulted from an inspection held at that facility in August 2011, and did not identify any new observations that were not provided in the Form 483 that followed the inspection.
The warning letter does not restrict the Company's ability to manufacture or ship products. Nor does it require the recall of any product. The Company has provided detailed responses to the FDA as to its corrective actions on a monthly basis, remains on track with its actions and is aggressively working to address all of the issues that the FDA identified.
Since the conclusion of the inspection in late August, 2011, Integra has undertaken significant efforts to remediate the observations that the FDA has made and continues to do so. The Company completed construction activities at the facility and all clean rooms were in production at the end of 2011. The Company has provided a copy of the warning letter as an exhibit in a Current Report on Form 8-K filed concurrently with the issuance of this press release.
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