Musculoskeletal News Roundup 1-Nov-07
BY LAUREN UZDIENSKI, NOVEMBER 1, 2007
Earnings
DJO reported 3Q:07 net revenues of $119.8 million, up 5.8% over 3Q:06. Excluding a 2006 revenue benefit from shipping terms and clearing of product backorders associated with Aircast, 3Q:07 revenue was up 7.6% to $121.8 million, in line with estimates. Non-GAAP net income for 3Q:07 was $8.2 million, or $0.34 per share, missing estimates by $0.05. Net income increased 23.9% over the year-ago period. The majority of the revenues came from the company's Domestic Rehabilitation products, which contributed $74.9 million to the quarter's revenues. DJO saw 37% revenue growth from the SpinaLogic® product line, and International sales were up 13%. DJO attributed International sales growth to the company's efforts to broaden its product lines in an expanding geographical footprint of direct distribution and favorable changes in foreign exchange rates.
Hanger Orthopedic Group announced 3Q:07 revenues of $162.3 million, representing a 7.1% increase over the year-ago period and beating estimates by $0.8 million. 3Q:07 net income of $5.4 million, or $0.18 per diluted share, was in line with estimates and reflected a 24.6% increase over the year-ago period. The company attributed revenue growth to a $6.9 million increase in same-center sales in the company's patient care business, a $1.6 million increase in sales of the company's distribution segment and a $1.8 million increase related to acquired entities.
Exactech announced 3Q:07 revenues of $30.0 million, up 23% over the year-ago period and beating estimates by $1.7 million. Net income was $2.5 million or $0.21 diluted earnings per share, up 35% and in line with estimates. The company said the sales growth was driven by domestic and international hip and knee sales and that results in the biologics and shoulder segments were "encouraging." Knee was up 19% to $14.3 million; hip, driven by the Novation® hip product line, was up 32% to $6.0 million; biologics revenue increased 25% to $4.2 million during the third quarter; and in shoulder, the Equinoxe® shoulder system was up 115% to $2.4 million.
Smith & Nephew reported 3Q:07 revenues of $845.0 million, an increase of 10% over the year-ago period, and beat analysts' estimates by $17.2 million. Adjusted income (excluding restructuring, acquisition-related and DOJ settlement costs) was $108 million, or $0.12 per share, up from $0.09 per share in the year-ago period. Reconstruction revenues were up 11% to $313.0 million in 3Q:07, driven by the BIRMINGHAM HIP Resurfacing System. Trauma and Clinical Therapies revenues increased by 11% to $156.0 million. Endoscopy revenues were up 9% worldwide and 17% in the U.S. to $176.0 million.
Cryolife reported 3Q:07 revenues of $22.2 million, beating estimates by $0.2 million and representing an 11% increase over the year-ago period. Net income for 3Q:07 was $1.9 million and $0.07 per basic and fully diluted common share, beating estimates by $0.03. Orthopedic tissue processing revenues in 3Q:07 were down 66% to $0.57 million, attributable to the company discontinuing the procuring and processing of such tissues in 1Q:07. Sales of BioGlue® were up 9% to $10.3 million for the quarter.
Nobel Biocare reported 3Q:07 revenues of EUR 143.3 million ($206.13 million), up 12% in local currencies from EUR 132.5 million ($191.0 million), and missing estimates of EUR 153.2 million ($220.83 million). Net profit for the quarter was EUR 35.5 million ($51.2 million), up from EUR 33.1 million ($47.7 million) in the year-ago period. Consensus estimates were EUR 37.8 million ($54.5 million). North American revenue increased 13.6% in local currencies in 3Q:07, regaining momentum after prior quarters.
M&A
Integra LifeSciences announced that it has completed its acquisition of IsoTis, Inc. for $7.25 in cash per share of IsoTis common stock, representing total consideration to IsoTis stockholders of approximately $51 million. All of IsoTis' outstanding $12.6 million in debt was repaid at closing.
Regulatory
Amedica announced 510(k) clearance for the company's Valeo™ Cervical Plate system. According to the press release, the system is intended for anterior screw fixation at C2 through C7, and the implant and instrumentation are designed such that the plate and screws can be placed in a single step.
AOI Medical Inc. has been asked by the FDA to conduct a clinical study of its BAMF (Balloon Assisted Management of Spine Fractures) Spine technology. Though details on the study are still being negotiated, the company said the study will be designed to support the BAMF Spine technology 510(k), with endpoints including successful deployment and cement delivery, as well as clinical outcome measures. As announced previously, the company expects the commercial launch of BAMF Spine product in the US in 2H:08.
Inion received CE Mark approval for BioRestore, a synthethic bioactive and biodegradable bone void filler indicated for orthopedic trauma, spine, CMF and dental procedures. The CE mark follows the news last week that the company received FDA approval to market BioRestore for orthopedic trauma and spinal procedures in the U.S.
Spinal Elements announced the launch of the Mosaic™ Gun, an instrument used to insert the Mosaic Spinal Implant System. According to the press release, the new instrument enables both distraction of the vertebral bodies and insertion of the Mosaic implant.
Product Introduction
ArthroCare announced several product launches this week, including the Opus® TwinLock™ Knotless Fixation System as part of the AutoCuff® System family of products for rotator cuff repair; the Quantum™, a controller platform for arthroscopic surgery; and new versions of its Coblation® Wands, the Super TurboVac® and Super MultiVac®, which are now equipped with finger switches and work with the Quantum controller.
BioMedical Enterprises Inc. launched OSSArc, a nitinol fixation implant designed for irregular bone surfaces and metaphyseal anatomy. The company says OSSArc is an enhancement of its OSStaple, and adds that it is "ideal" for procedures such as the Akin osteotomies and Jones fractures in the foot and phalangeal and metacarpal fractures in the hand.
Medtronic launched its CD Horizon® Legacy™ Anterior Spinal System in the U.S. According to the press release, the CD Horizon Legacy Anterior Spinal System offers an anterior fixation solution and is designed to assist with stability of the thoracic and lumbar spine during fusion surgery. The company adds that the CD Horizon Legacy Anterior Spinal System consists of a series of vertebral body staples, rods, screws, Crosslink® Plates, and connecting components that allows for distraction to accommodate bone graft.
VertiFlex Inc. announced the launch of the Superion™ Interspinous Spacer in countries outside the U.S. The Superion implant is placed percutaneously between the spinous processes without the need to cut paraspinal muscles; the company describes the procedure as follows: "a small incision is made posteriorly to the midline and the implant is delivered through a small cannula. The entire surgery is performed under local anesthesia and the average surgery time has been 25 minutes or less."
Investigations
Biomet, DePuy, Smith & Nephew, Stryker and Zimmer's websites now feature disclosures of the companies' payments to consultants. The public disclosure of consultant payments was among the terms in the deferred prosecution agreements (in Stryker's case, a non-prosecution agreement) between the aforementioned companies and the DOJ.
Clinical
BioMimetic Therapeutics announced that a study designed and sponsored by the company has received the R. Earl Robinson Regeneration Award from the American Academy of Periodontology for the most outstanding scientific publication in the field of regenerative medicine and periodontics. This is the second consecutive year BMTI has received the award. According to the press release, the paper "demonstrated that new composite endpoints combining clinical and radiological measurements may be used to accurately assess regenerative outcomes concurrently on both bone and adjacent soft tissues." The publication was authored by three BMTI executives and two other scientific collaborators.
Appointment
Raymedica announced the appointment of Ralph F. Rashbaum, M.D. to Raymedica’s Surgeon Advisory Board. Dr. Rashbaum co-founded the Texas Back Institute and also serves as Assistant Clinical Professor at the University of Texas Southwestern Medical School in Dallas. Also appointed to Raymedica's Surgeon Advisory Board is John S. Thalgott, M.D. Dr. Thalgott is Director of the Center for Diseases & Surgery of the Spine in Las Vegas, Nevada.
San Diego-based SpineOvations announced that Joseph Mussey has been appointed to its Board of Directors. Mussey has served as President and Chief Operating Officer at Interpore Cross International.
