Wright releases positive prelim Q4 and FY 2014 results; progress on Augment

Wright Medical Group ($WMGI) said it expects to report positive revenue numbers for both the fourth quarter and full year based on its improved U.S. foot and ankle business and new product launches.

The company also said that despite a Federal Trade Commission review of its $3.3 billion inversion deal with Netherlands-based Tornier, it expects to close the merger in the first half of this year, and currently "does not believe any divestitures" will be required for regulatory approval. The inversion deal was one of the first since release of the FTC's rules to deter the tax-saving practice.

The Memphis-based med tech outfit said in a release of its preliminary financial results that Q4 revenue rose 23% (25% on constant currency basis) to $83.3 million compared with the same period last year. Full-year revenue results are projected to be $298 million, which represents a 23% gain both reported and on a constant currency basis from the previous year, the company said. Gross margins for the quarter and year ending Dec. 31 are expected to be about 77%.

The preliminary results were based on current expectations and are subject to quarter-end closing adjustments. Fourth-quarter and full-year results are scheduled to be released Feb. 25.

Wright CEO Robert Palmisano

"Our U.S. foot and ankle business grew approximately 39% on an as reported basis, up significantly from 28% in the third quarter of this year," Robert Palmisano, president and CEO, said in a statement. "In particular, global total ankle growth is expected to be approximately 38% for the quarter, driven primarily by the ongoing launch of our Infinity total ankle replacement system."

Palmisano also said that one of the two pre-approval facility inspections the FDA required before giving its OK for Wright's Augment bone graft product has been completed without any 483 observations cited by inspectors. The company said FDA approval for Augment could come by the end of the first quarter.

In May last year, Wright submitted a PMA amendment for Augment in what amounted to a compromise with the FDA, which rejected the bone graft in 2013. The FDA rejection sent company shares plummeting. For many on Wall Street, the company's potential remains closely tied to the success or failure of Augment.

- see the release