Integra LifeSciences recalls some collagen items
PLAINSBORO, N.J. (AP) — Medical device maker Integra LifeSciences Holdings Corp. said Wednesday it is recalling some collagen products that were made at a facility in Puerto Rico because of manufacturing problems.
The company said it is taking some production lots of its DuraGen and Dural Graft Matrix products off the market because of possible "deviations from approved manufacturing processes." The products were made at a facility in Añasco, Puerto Rico, between December 2010 and May 2011 and between November 2012 and March 2013. Integra said it isn't aware of any side effects related to the manufacturing problems.
The facility is still online and Integra said it is still selling products that were made there. But the recall marks the latest manufacturing problem for Integra: since the beginning of 2012 the company has received warning letters from the Food and Drug Administration regarding its manufacturing facilities in Andover, U.K., and in Plainsboro as well as the Añasco location.
The FDA sent Integra a warning letter about the Añasco facility in February. The agency said Integra was not meeting quality system requirements, and as a result, the agency was "concerned" about the quality of all the collagen products made in the facility. Integra said in February that it believed it had addressed most of the problems the FDA cited.
The company says about 18 percent of its revenue comes from items made at the Añasco location, including the collagen products and other devices. Based on the company's 2012 results, that figure suggests a total of about $150 million in revenue.
Shares of Integra LifeSciences slumped $2.69, or 7 percent, to $35.69 in after-hours trading. The stock rose 48 cents to $38.38 during regular trading Wednesday.
Integra said it expects to take charges totaling $2.5 million to $4.5 million related to the recall in the first quarter, and said its revenue will be $8 million to $11 million lower than it had previously anticipated. The company expects to post a net loss of 8 cents to 30 cents per share for the period, and said adjusted income will be between 30 and 40 cents per share if the recall costs and other items are excluded.
Integra is forecasting $194 million to $197 million in revenue for the first quarter.
Analysts expected adjusted income of 71 cents per share and $204 million in revenue, according to FactSet.
The company said it doesn't expect to be able to meet all demand for the DuraGen and Dural Graft products in the second quarter, and said revenue for that period will be between $205 million to $211 million.
Analysts expected $219.4 million, on average.
Integra said it is evaluating the effects of the recall and the charges on its results for the full year, and said it plans to update its 2013 projections during its first-quarter conference call on May 2. In February the company forecast full-year net income of $1.68 to $1.87 per share, or $3.08 to $3.27 per share excluding one-time costs and gains. It expected revenue of $865 million to $880 million.
Analysts were projecting adjusted net income of $3.15 per share and $870.3 million in revenue.