Medical device maker Integra LifeSciences Holdings Corp. (IART), said Wednesday it is recalling certain products made in its Anasco, Puerto Rico facility owing to deviations in approved production processes.
Integra slashed its revenue and earnings expectations for the first quarter to reflect the recall as well as product shortages. The company will update the impact of the recall on fiscal 2013 results.
The news had a negative impact on the company's stock, which sank 7 percent in after-hours trade on the Nasdaq.
Integra expects first-quarter revenues to be lower-than-expected by $8 million to $11 million and now estimates revenues of $194 million to $197 million. Analysts polled by Thomson Reuters currently estimate revenues of $204.69 million for the quarter.
Integra expects a net loss of $0.30 to $0.08 per share and adjusted earnings of $0.30 to $0.40 per share for the first quarter.
Analysts on consensus currently estimate earnings of $0.69 per share for the first quarter. Analysts' estimates typically exclude special items.
The guidance includes related incremental expense of $2.5 million to $4.5 million.
Integra expects it will not be able to meet all the demand for the affected products during the second quarter and now estimates that revenues for the period will be between $205 million and $211 million.
The company is evaluating its guidance for the fiscal 2013 and expects to update it to incorporate the full impact of the recall.
In February, Integra had estimated full year net earnings of $1.68 to $1.87 per share, adjusted earnings of $3.08 to $3.27 per share, and sales of $865 to $880 million. Analysts currently estimate earnings of $3.10 per share on sales of $871.14 million for.
There have been no reports of adverse patient events related to the products being recalled. Integra continues to manufacture all the affected products at its Anasco facility, which makes several collagen products, including Duragen Dural Graft Matrix, which is among those being recalled. Sales of products made or packaged in the Anasco facility constituted about 18 percent of Integra's revenues in 2012.
The recall follows a warning in February by the US Food and Drug, which raised concerns about quality systems issues at the Anasco facility. At that time, Integra said it has substantially rectified the issues addressed in the warning letter.
Integra LifeSciences closed Wednesday at $38.38, up 1.27%. In after hours, the stock dropped $2.69 or 7.01%.
by RTT Staff Writer
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