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3Q10 Company Financials: Orthopaedic and Spine

Biomet (fiscal 1Q11, ended 8/31/10)

  • $640.7MM, +3%
  • Reconstructive 478.4MM, +4% (Hips +2%, Knees +5%, Extremities +27%, Other -3%, Dental -1%)
  • Fixation -2%
  • Spine $57.9MM, flat
  • Other Products $45MM, +8% (Sports Med +17%, Soft Goods/Bracing -1%)

Recon

  • >70% of U.S. acetabular unit volume derived from “super premium” category (includes E1 and metal-on-metal systems)
  • Continues to note drivers impacting growth, e.g. end of COBRA subsidies, high unemployment, changes in private insurance market
  • European performance impacted by slightly declining hip/knee market, negative recon ASPs, slightly more price pressure than 4Q, steep market decline and price decrease in Greece, significant price decline in Turkey
  • Price mix impact on hip/knee fairly consistent with previous quarter, U.S. ASPs declined slightly, offset by positive product mix
  • Will launch Arcos Modular Revision Hip in 2QFY11; E1 Active Articulation dual mobility system now slated for U.S. launch in 2HFY11
  • Signature Personalized Patient Care update: received FDA warning letter alleging inappropriate clearance to market (See BARE BONES®, 9/10.), filed additional 510(k) in 9/10
  • Continued surge in demand for comprehensive primary, reverse and fracture shoulder systems in U.S. (comprehensive system well-received in Europe)
  • Will train 200 U.S. surgeons on comprehensive subsystem in 2Q

Trauma and Spine

  • Continued price and volume pressure in spine core segments
  • Introduced Enclave Anterior Spinal System, a PEEK Optima spacer with open design for anterior or anterolateral approach, and Valiant Anterior Lumbar Plate, low-profile taper design

Other

  • Acquired Cytosol, producer of small volume anticoagulants (See BARE BONES, 8/10.); will ensure provision of critical supply component used in GPS Platelet Separation System
 BioMimetic Therapeutics
  • Developing 3 products for Sports Medicine, including intratendon, tendon-to-bone and cartilage repair; initial clinical trial expected by year-end to focus on rotator cuff
  • Wrapping up spine fusion study in large animal trial (more information potentially by next AAOS meeting)

Augment Bone Graft

  • Completed 100-day Premarket Approval meeting w/FDA for foot/ankle fusion, no unexpected issues impacting potential clearance in 2011
  • 17 institutions in Canada either used or cleared use of Augment, on track to meet goal of 20-25 by year-end
  • Transitioning to network of independent sales agents in Canada, will reach 25 by year-end
  • Filed for regulatory in Australia, expect clearance by end of 2011

Augment Injectable Bone Graft

  • Received FDA determination that product review will follow medical device pathway, will initiate enrollment in U.S. pivotal trial after approval of Investigational Device Exemption study, which is expected by year-end

CareFusion

  • Noting progress with launch of AVAmax Vertebral Balloon for kyphoplasty in U.S., has a modest revenue plan, encouraged by market interest and user feedback
  • ~100 hospitals now using product

ConMed

  • $102.8MM, -3%
  • Arthroscopy $68.2MM, -0.4%
  • Powered Instruments $34.6MM, -7%
  • Strong market acceptance continues for Shoulder Restoration System and recently-launched PopLok device for shoulder instability
  • Will launch device for arthroscopic knee repair by year-end

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