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Company Financials: Orthopaedics and Spine

AAP IMPLANTATE
€9.9MM (~US $12.7MM), +51%

  • LOQTEQ update: presented to potential new distributors in Asia, Europe, Latin America and U.S.; expecting full FDA clearance in 3Q

ALPHATEC SPINE
$48.4MM, -3% (U.S. $32.5MM, -4%; Ex-U.S. $15.9MM, flat)

  • Will take on in-house manufacturing of certain high-volume, high-cost products, 1st to be Trestle Luxe anterior cervical plate
  • Late in quarter, voluntarily recalled deployment instrument for Solus Anterior Lumbar Interbody Fusion device (in beta launch) to improve its performance in surgeries involving extremely hard or sclerotic bone (a problem not dissimilar from other standalone ALIF devices)
  • Modifications to Solus instrumentation expected to require resubmission of 510(k); expects product back to market by year-end
  • Physician-owned distributorships account for substantially <10% of U.S. business, and declining

ARTHROCARE
$61.2MM, +3%
• Sports Medicine $59.3MM, +5% (Americas +7%, International +5%)
• Other (includes Spine) $1.8MM, -24%

  • 2012 product launches include MultiFIX P knotless fixation, pound-in implant composed entirely of PEEK (primarily for rotator cuff repair) and MegaVac Wand, 90-degree suction wand that reportedly ablates tissue 40% faster than leading competitor’s product
  • Recent Civil Investigative Demand relates to ENT business

BIOMET (fiscal quarter ended 2/29/12)
$708.9MM, +5% (U.S. $432.8MM, +5%; Europe $176.7MM, +4%; International $99.4MM, +6%)

Reconstructive $422.7MM, +5% (U.S. +6%)
• Hips +6% (U.S. +7%)
• Knees +4% (U.S. +4%)
• Bone Cement/Other +7% (U.S. +8%)
Sports, Extremities, Trauma (S.E.T.) $92.7MM, +16% (U.S. +15%)
• Sports Medicine +22% (U.S. +18%)
• Extremities +18% (U.S. +21%)
• Trauma 1% (U.S. -6%)
Spine & Bone Healing $76.5MM, -5% (U.S. -5%)
• Spine -3% (U.S. -3%)
• Bone Healing -10% (U.S. -10%)
Other $51.4MM, +9%
(Growth includes dental.)

Binding offer for DePuy’s trauma assets

  • DePuy’s U.S. distributors are making available dedicated trauma reps, managers and specialists to interview Will offer full-time positions to DePuy’s dedicated sales reps in Japan, U.K.
  • Commenced acquisition in 6/12

Recon

  • Volume of custom implants very, very low, not a material driver of mix
  • Gained market share in Europe hips/knees (particularly strong in Germany, U.K.), Japan and Australia hips and Canada knees
  • Metal-on-Metal <10% of hip sales, Super Premium Bearing ~70% of domestic acetabular units
  • Continued strong demand in Europe, U.S. for Taperloc Complete Hip, will release >100 additional sets to field in FY4Q
  • Very strong market acceptance of cementless Global Tissue Sparing Hip Stem in Europe and Active Articulation Dual Mobility Hip in U.S.
  • New knee technologies, including Oxford Microplasty instruments and Signature for Oxford, contributing to stabilization for Oxford line
  • Launching Signature for Oxford in Europe in FY4Q

Spine/Bone Healing

  • FY4Q launch slated for Solitaire C, stand-alone cervical spacer (PEEK-Optima + titanium faceplate), “deroduction” (derotation and rod reduction) instruments for Trivium Deformity Correction
  • Planning FY1Q13 launch of Celentra Viable Cell Bone Matrix

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