2010 Company Financials: Orthopaedic and Spine

Here are the remaining full-year performance highlights for select orthopaedic companies. We include 4Q10 revenue breakdowns where available, as well. Detail relates to full year, unless otherwise noted. Exhibit 1 displays growth by product segment.

Exhibit 1: Orthopaedic Sales1 Increases by Product Segment: 2010 vs. 2009

vet-1

NOTES TO EXHIBIT 1

1. Orthopaedic products only; constant currency, pro forma growth
2. Includes biologics
3. ORTHOWORLD estimate for the quarter ended 11/30/10; excludes dental; trauma includes stimulators; spine includes stimulators and orthobiologics.
4. For the 12 months ended 1/31/11
5. Spine
6. Endoscopy (most of which is orthopaedic)
7. ORTHOWORLD estimates
8. Excludes "Other" (Aerospace)


AAP IMPLANTATE

€28.4MM (~US $40.2MM), -14%

ANIKA THERAPEUTICS
Orthobiologics $30.7MM, +34% (ORTHOVISC U.S. +32%, ex-U.S. -8%; MONOVISC in EU +126%)
4Q10 revenue: $8.4MM, +40% (U.S. +25%, ex-U.S. +96%; ORTHOVISC U.S. +25%, ex-U.S. +21%)

  • Requested review of MONOVISC via FDA’s orthopaedic advisory panel, no meeting date set yet

BACTERIN
$15.4MM, +~109%
• Tissue Sales $15.2MM, +114%
• Royalties/Other $0.2MM, -30%
4Q10 revenue:
$5.3MM, +~141%
• Tissue Sales $5.2MM, +150%
• Royalties/Other $0.9MM, -88%

  • Secured ~$15MM in funding
  • OsteoSponge ~45%-50% of 2010 revenue
  • Launched OsteoSelect DBM Putty, OsteoSponge SC, hMatrix
  • Increased direct and indirect biologics sales force by >150% (includes 52 biologics sales reps, will grow to 64 by end of 2011)

BIOMIMETIC THERAPEUTICS
Augment Bone Graft

  • ~650 patients enrolled in Augment clinical trials over 4 years
  • FDA orthopaedic advisory panel meeting confirmed for 5/11 to review premarket approval application
  • In Canada, transitioning from single exclusive distributor to network of >30 independent agents covering whole country
  • Presented preclinical study results demonstrating beneficial effects of technology on cartilage and bone repair in knee, effectiveness of rhPDGF-BB intra-tendon delivery for tendon repair
  • Announced results of preclinical study of interbody lumbar fusion in 2-level ovine model: Augment-treated specimens demonstrated highest fusion scores, showed equivalency to autograft

CHINA KANGHUI

RMB 242.7MM (~US $36.9MM), +32% (Japan ~$1.4MM; Domestic +30%, International +77%)
• Trauma $23.5MM, +36%
• Spine $10.3MM, +36%
• OEM $3MM, -3%
4Q10 revenue:
RMB 72.3MM ($11MM), +33%
• Trauma $8.4MM, +23%
• Spine $1.6MM, +70%
• OEM $0.9MM, +15%

  • 4Q10 results driven by L-8/U-Spine pedicle fixation and PolyNices thoracolumbar systems
  • In 3/11, acquired majority stake in Wei Rui (recon), will launch knee product in China early 2012
  • 2011 launches include kyphoplasty system

CORIN
£44.8MM (~US $73.3MM), +6%
• Hips $32.1MM, +1% (non-Metal-on-Metal [MoM] +21%)
• Knees $15.3MM, -13%
• Other $25.8MM, +32%

Hips

  • 2H10 non-MoM hips +28% (vs. +15% in 1H10)
  • MoM ~10% of sales in 2010 (~40% in 2008)
  • MiniHip gaining significant interest in U.S., U.K., Australia
  • Achieved CE Mark approval for ECIMA
  • advanced highly crosslinked polyethylene liner, commenced evaluation surgeries using ECIMA plus Trinity cup
  • Rolling out number of enhancements to hip portfolio, including extensions to Trinity, more liner/shell options, additional cementless hip stem
  • In Japan, expecting to launch CTi2 hip during 2011
  • Upgrading Taperfit hip stem with complete offering of sizes to launch in 2011
  • Will not launch Trinity cup in U.S. until other options in cup system are cleared, expected in 2Q11
  • In 3/11, entered into agreement to supply hip implants (initially MetaFix and Trinity) to MAKO Surgical for use with RIO Robotic Arm Interactive Orthopedic system

Knees

  • Decline in mature systems noted specifically in Germany, Turkey
  • Will commence Unity total knee system evaluation surgeries in 2011, launch in 2012
  • Will add metal-backed fixed tibia option to Uniglide in 2011

Other

  • Increasing interest for use of LARS ligament augmentation system for ligament/tendon injuries throughout the body
  • Zenith Ankle contributed strong growth in U.K.

ORTHOVITA

$94.7MM, +2% (Biosurgery +6%; Vitoss -4%; Vitoss Bioactive Foam +8%; U.S. Cortoss and Aliquot $4MM, +263%)
4Q10 revenue: $23.4MM, -4% (Biosurgery $5.7MM, flat; Vitoss Bone Graft Substitute -6%, Vitoss Bioactive Foam +3%, Vitoss Morsels +1%, U.S. Cortoss and Aliquot $0.8MM, +14%)

  • 4Q sales reflect continued weakness in ortho and spine
  • Realized modest increases of 1% to 2% in 4Q Vitoss and Biosurgery pricing; hemostatis pricing stable
  • Losing Vitoss Classic Foam sales to lower-priced competition (major hardware suppliers heavily discounting standard bone grafts as part of larger package)
  • Anticipates adjusting price for Vitoss Classic on case-by-case basis
  • Recently launched Vitoss Bioactive Foam 2X (BA2X), has 50% more bioactive glass than Vitoss BA
  • Received FDA clearance of Vitoss BA Bimodal
  • Launched new marketing to promote use of Vitagel hemostatis product in joint recon
  • On track to launch cavity creation device (directional bone tamp) in mid-2011; expects clearance for balloon bone tamp in 2012
  • Will file 510(k) for Cortoss for cranial defect repair in 3Q11
  • Launching Bimodal by end of 2011 or early 2012 depending on performance of BA2X
  • Developing new structural biomaterial BA PEEK with bioactive glass
  • Hybrid sales force of 70-75 direct sales reps (DSRs), ~25 distributors and 40 independent agents
  • DSRs provided ~60% of sales in 4Q

TIGENIX
€2.4MM (~US $3.4MM) +135%

ChondroCelect

  • 43 patients treated throughout Europe
  • Received regulatory clearance and reimbursement in Belgium
  • Discussions advancing in other countries (e.g. France, Germany, Netherlands, Spain, U.K.) relative to pricing, reimbursement

ChondroMimetic

  • Launched in 9/10 with distribution agreements signed in Europe

Sources: Company press releases, earnings calls, filings with the Securities and Exchange Commission


Julie A. Vetalice is Editor, Information for ORTHOWORLD, Inc. She can be reached at 440.543.2101 or This email address is being protected from spambots. You need JavaScript enabled to view it..