Musculoskeletal News Roundup 26-July-07
BY LAUREN UZDIENSKI, JULY 26, 2007
Earnings
Stryker reported revenues of $1.46 billion, beating estimates of $1.44 billion and increasing 16% from $1.26 billion in 2Q:06. 2Q:07 earnings were $269.1 million, or $0.65 per share, beating estimates of $0.61 and up from $0.52 in the comparable quarter. The orthopedics business reported revenues of $883.3 million in the quarter, up 14.6% over 2Q:06.
Anika reported 2Q:07 revenue of $6.33 million compared with $7.12 million in the comparable quarter. Net income was $1.37 million, or $0.12 per diluted share, flat in comparison to 2Q:06. The company attributed the decline in revenue to the change in the Turkish government's reimbursement policy, which resulted in a loss of ORTHOVISC® sales from the second half of 2006 through May of 2007. 2Q:07 ORTHOVISC sales in Turkey were $2.4 million. U.S. ORTHOVISC revenue increased 66% in 2Q:07, attributed to the unique reimbursement code assigned to ORTHOVISC in January and an increased number of Mitek sales specialists.
LifeCell announced 2Q:07 revenues of $47.6 million, beating estimate of $44.70 million and up 33% from $35.7 million in 2Q:06. The growth was attributed primarily to increased demand for the AlloDerm® Regenerative Tissue Matrix. Orthopedic product revenues, which include Graft Jacket® and AlloCraft™DBM, increased to $3.2 million from $2.3 million in 2Q:06. Net income for the second quarter of 2007 was $7.7 million, or $.22 per diluted share, beating estimates of $0.19 and increasing from $5.1 million, or $.15 per diluted share, in 2Q:06.
Zimmer reported 2Q:07 revenues of $971.0 million, missing estimates of $975.05 million and reflecting an increase of 8% constant currency over 2Q:06. Adjusted diluted earnings per share for the quarter were $0.98, meeting estimates and marking an increase of 18% over the comparable quarter. Reconstructive sales were up 10% in the Americas and 9% worldwide; knees were up 9% in the Americas and 8% worldwide; hips were up 8% in the Americas and and 6% worldwide; extremities grew 33%; dental grew 19%; trauma grew 1% and spine grew 6%.
NuVasive reported revenues of $35.6 million, up 56.7% from 2Q:06 and beating estimates of $33.63 million. Earnings per share was $0.01, beating estimates of $(0.13). CEO Alexis V. Lukianov attributed the growth to the effectiveness of NuVasive's exclusive sales force and success with the newly-launched products as well as proliferation of the XLIF® technique.
Genzyme reported revenues of $933.4 million, up 18% from the comparable quarter. Net non-GAAP income rose to $238.7 million, a 32% increase from $181.2 million in 2Q:06. Earnings were $0.88 per diluted share, up from $0.68 in the comparable quarter. Both earnings and sales beat estimates, which called for earnings of $0.81 per share and $912.1 million in revenue. Sales of Synvisc were $64.9 million, a 2% increase over 2Q:06.
CONMED reported net income of $10.2 million, or $0.35 per diluted share, up 54% from 2Q:06 and beating estimates of $0.31. Revenues were up 3.5% to $169.3 million, missing estimates of $171.63 million. The Orthopedic product lines of Arthroscopy and Powered Surgical Instruments had combined sales growth of 9.6% over the comparable quarter.
Funding
Spine company TranS1 filed a registration statement with the SEC for an initial public offering of its common stock. The proposed maximum aggregate offering price is $80.5 million, and the company intends to apply to list on the Nasdaq under the symbol "TSON." The offering is being made through Lehman Brothers, Piper Jaffray, Cowen and Company and Leerink Swann & Company.
Reimbursement
DePuy Spine announced that CIGNA will now cover artificial disc replacement for single-level degenerative disc disease, reversing an earlier decision. Cigna joins Aetna, Kaiser Permanente and Horizon Blue Cross Blue Shield as well as multiple regional insurers in covering the disc.
Legal
The patent infringement lawsuit between BioMedical Enterprises, Inc. and InteliFUSE has been stayed pending the Court's disposition of a motion for summary judgment brought by BME.
The patent infringment trial brought by Synthes against Globus Medical began this week in a federal court in Philadelphia. Synthes accuses Globus of benefiting from the use of trade secrets and confidential information, including product designs, manufacturing methods and regulatory strategies.
License Agreements
Medtronic entered into a distribution and development agreement with Axon Systems, a developer of neuromonitoring technology used during spinal surgery. The companies plan to launch the NIM-ECLIPSE™ Spinal System of neuromonitoring capital and disposable equipment. The system offers automatic pedicle screw monitoring with direct nerve and screw stimulation and may also be used during surgery to monitor neural pathways.
Product Introduction and Update
Depuy launched the Peak Fx™ Hip Plate System. The system is designed stabilize the hip and prevent unnecessary trauma to tissues surrounding the surgical site, and the instruments used with the Peak Fx™ System have been modified to reduce OR time and simplify the procedure.
Pioneer Surgical Technology launched its Quantum Minimally Invasive Spinal Surgery Rodding System for the lumbar spine. This system is designed for one or two-level fixation and uses Quantum® Polyaxial Screws and Locking Caps along with Titanium Alloy Rods. The system is designed to increase surgeon control in MIS.
Massachusetts General Hospital surgeons performed the first total hip replacement with Biomet's vitamin-E-stabilized, highly crosslinked polyethylene as part of an international study to test the new material. Zimmer also holds a license for the e-poly, which was developed at MGH.
Scient'x announced that its second-generation cervical disc prosthesis has been implanted in 1,000 patients worldwide. The Discocerv artificial disc offers a unique design to restore normal biomechanical motion after discectomy and to prevent adjacent level degeneration. The implant and instruments have been carefully developed with leading surgeons in order to provide a one-step only surgical technique, as easy as the insertion of a cervical cage.
Clinical
Mesoblast Ltd., an Australian stem cell company, announced that they have initiated a clinical trial evaluating the use of universal donor stem cells for patients with intervertebral disc disease and who require spinal fusion. The study will be Mesoblast's first in the U.S. and will be conducted at the Hospital for Special Surgery.
Appointment
Alphatec Holdings, Inc. announced that Mortimer Berkowitz III was appointed to serve as Alphatec's Chairman of the Board of Directors. Mr. Berkowitz has served as a member of Alphatec's Board of Directors since July 2005. John H. Foster, the previous Chairman of the Board of Directors, will remain a member of Alphatec's Board of Directors.
BioMedical Enterprises, Inc., which is focused on the clinical development of orthopedic nitinol implants, appointed Rory Gleadhill Vice President of Sales and Marketing. Mr. Gleadhill's previous roles include Vice President of Spine and Biologics at Interpore Cross International and tenure at Smith & Nephew.
Spinal Elements, Inc. named Dale Binke Vice President of Sales. Effective immediately, Binke will manage worldwide sales and distribution for the company. Binke brings 21 years of medical device experience to Spinal Elements, including his most recent post of Sales Director of Medtronic's CRDM business.
Miscellaneous
Premier announced that their spine portfolio contracts have saved members more than $30.0 million since the July 2006 portfolio launch. Companies involved include Aesculap Implant Systems, Inc., Biomet Spine, Medtronic Sofamor Danek and Osteotech, Inc. The contracts include spinal hardware, stimulation and biologic products for both pediatric and adult patients.
