Wright Medical (NSDQ:WMGI) today pushed back the timeline for FDA approval of its Augment bone putty, after the safety watchdog said last month that the vendor that makes Augment must undergo another site inspection.
In early February Memphis-based Wright said that an FDA inspection conducted as part of a review of Augment prompted a Form 483 warning to the vendor. Today Wright, in reporting its 1st-quarter earnings, said it asked the FDA to schedule the follow-up inspection on or after May 4.
"Assuming a satisfactory inspection result, the company believes final approval of Augment bone graft now appears more likely in the 2nd half of 2015," Wright said.
"We are continuing to work closely with the vendor to resolve the observations following an FDA inspection at the vendor’s facility to receive final FDA approval for Augment bone graft," president & CEO Robert Palmisano added in prepared remarks.
Wright is also predicting a 2nd-half closing for its pending, $3.3 billion merger-of-equals with Tornier (NSDQ:TRNX), contingent on the sale of some Tornier assets to satisfy the U.S. Federal Trade Commission.
"Tornier has been actively pursuing divestiture of the Tornier lower extremity products cited in FTC’s 2nd request, which are the Tornier Salto Talaris and Salto XT ankle replacement products and the Tornier silastic toe replacement products," Wright said, noting that it plans to schedule shareholder votes in mid-June.
"From a timing standpoint, while an end of second quarter 2015 closing is still possible, we continue to believe a third quarter close is more likely," the company said.
Wright also said its 1st-quarter losses grew by more than 63%, to -$49.7 million, or -98¢ per share, on sales growth of 9.7% to $77.9 million for the 3 months ended 31. Adjusted to exclude 1-time items, earnings per share were -51¢, missing Wall Street’s forecast by 6¢ but beating analysts’ $74.9 million top-line expectations.
Wright confirmed its outlook for the rest of the year, saying it still expects to report adjusted EPS of -$1.67 to -$1.77 on sales of $325 million to $335 million, representing constant-currency growth of 13% to 16%. The company said it plans to give updated guidance after the Tornier deal closes.
WMGI shares closed down -0.4% at $25.65 today.