Wright Medical Group, Inc. Announces Receipt of Second Request From Federal Trade Commission Regarding Proposed Merger With Tornier N.V. (2/03/15)
Also Provides Update on Pre-Approval Vendor Inspection by FDA for Augment(R) Bone Graft
MEMPHIS, Tenn., Feb. 2, 2015 (GLOBE NEWSWIRE) -- Wright Medical Group, Inc. (Nasdaq:WMGI) today announced that on January 28, 2015 it received from the Federal Trade Commission ("FTC") a Request for Additional Information and Documentary Material (commonly known as a "Second Request") in connection with its proposed merger with Tornier N.V. Wright also announced that the previously disclosed pending pre-approval inspection of an Augment Bone Graft vendor had concluded and resulted in the issuance of a Form 483 containing certain observations to which the vendor has already responded.
Update on Hart-Scott-Rodino Review Process for Proposed Merger with Tornier N.V.
On January 28, 2015, Wright received a Second Request in connection with the proposed merger with Tornier. Issuance of the Second Request extends the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, until 30 days after both parties have substantially complied with the Second Request, unless that period is extended voluntarily by the parties or terminated sooner by the FTC. The Company intends to cooperate fully with the FTC.
All product lines identified in the Second Request are lower extremity products. Tornier has indicated that, for the period ended September 30, 2014, its lower extremity product lines identified in the Second Request accounted for, in the aggregate, global revenue of approximately $21 million, and U.S. revenue of approximately $14.9 million, which is less than the $15 million U.S. revenue threshold identified in Section 6.05(e) of the merger agreement. The Company continues to believe that, whatever the resolution of the Second Request, the economics and strategic rationale of the transaction will not materially be affected, and the transaction will close. From a timing standpoint, the Company believes a second quarter 2015 closing is still possible, but is now a best-case scenario. In addition to obtaining FTC clearance, the proposed transaction remains subject to customary closing conditions, including approval by both Wright and Tornier shareholders.
Robert Palmisano, president and chief executive officer, stated, "We just received the Second Request and are evaluating our options. We will continue to work cooperatively with the FTC to resolve this as quickly as possible. Whatever the final resolution, we do not expect it to have a material impact on the strategic rationale or economics of the proposed merger, and we remain firmly committed to the transaction."
Update on Augment Pre-Approval Inspection
Wright also announced that one of its vendors received a Form 483 at completion of a recent FDA pre-approval inspection for Augment® Bone Graft. The 483 cited several observations. The vendor has submitted a full response to FDA that the vendor and the Company believe will satisfactorily address the FDA's observations. Based on this, Wright continues to anticipate final approval of Augment® Bone Graft in the first half of 2015 but believes a first quarter approval is unlikely.
Internet Posting of Information
Wright routinely posts information that may be important to investors in the "Investor Relations" section of its website at www.wmt.com. The Company encourages investors and potential investors to consult our website regularly for important information about us.
About Wright Medical
Wright Medical Group, Inc. is a specialty orthopaedic company that provides extremity and biologic solutions that enable clinicians to alleviate pain and restore their patients' lifestyles. The company is the recognized leader of surgical solutions for the foot and ankle market, one of the fastest growing segments in medical technology, and markets its products in over 60 countries worldwide. For more information about Wright Medical, visit www.wmt.com http://globenewswire.com/news-release/2015/02/02/702208/10118133/en/Wright-Medical-Group-Inc-Announces-Receipt-of-Second-Request-From-Federal-Trade-Commission-Regarding-Proposed-Merger-With-Tornier-N-V.html