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$ZBH received FDA clearance for the Sidus Stem-Free Shoulder system. This is a total shoulder arthroplasty solution for patients with good bone stock that have either osteoarthritis, post-traumatic arthrosis, focal avascular necrosis of the humeral head or who had previous surgeries of the shoulder that do not compromise the fixation.
$ZBH appointed Bryan Hanson as President and CEO and a member of the BoD, effective Dec. 19, 2017. Daniel Florin, who has served as Interim CEO since July 11, 2017, will continue in his role as SVP and CFO. Most recently, Hanson served as a $MDT's Executive Committee member and as EVP and President of Medtronic's Minimally Invasive Therapies Group.
Medical device company $ZBH announced that the U.S. FDA has notified the company about the closing out of its warning letter dated June 3, 2015 relating to its Zhejiang, China manufacturing facility. The company added that it will continue to take the necessary actions towards stricter quality control and regulatory compliance going forward.
During 4Q16, $ZBH continued to make progress towards enhancing and improving its supply chain and manufacturing and quality systems. The company anticipates continued progress towards the replenishment of safety stocks on key cross-sell products throughout 1H17, which will accelerate top line growth during 2H17.
$ZBH expects constant currency revenue for FY17 to increase by approx. 3.7-4.7%. $ZBH expects foreign currency translation to decrease revenues by approx. 1.5%. Therefore, revenue is expected to be in a range of $7.855-7.930Bil. The Company expects its FY17 diluted EPS to be in a range of $4.37-4.67.
$ZBH implemented a leadership transition that capitalizes on the strength of the its management team. Effective Jan. 23, 2017, Robert Delp will assume the position of President, Americas and join the executive leadership team of the company. Stuart Kleopfer has decided to retire from his position as President, Americas.
$ZBH concluded agreements with the U.S. Department of Justice and the U.S. Securities and Exchange Commission to resolve the U.S. Foreign Corrupt Practices Act (FCPA) matters involving Biomet as well as in relation to former deferred prosecution agreement and consent to final judgment that Biomet entered into with DOJ and SEC, on March 26, 2012.
$ZBH expects 2016 net sales of $7.684Bil, up 28.1% from last year. On an adjusted constant currency basis, $ZBH sees revenue to increase by 3.4%. Excluding contribution from the LDR Holding transaction, revenue rose by 2.3% on an adjusted constant currency basis. $ZBH now sees adjusted EPS to be towards upper end of prior estimate of $7.90-7.95.
$ZBH expects 4Q16 net sales of about $2.013Bil, an increase of 4.1% over last year. On adjusted constant currency basis, revenue increased by 4.4%. Excluding the contribution from the LDR transaction and adjusting for one less billing day in the quarter, $ZBH estimates that revenues increased 3.5% over 4Q15.
$ZBH priced an offering of EUR 500MM of its 1.414% senior unsecured notes due 2022 and EUR 500MM of 2.425% senior unsecured notes due 2026. The closing is expected to occur on Dec. 13, 2016. The notes will pay interest on an annual basis. The joint book-running managers for the offering are BNP Paribas, HSBC Bank plc and RBC Europe Limited.