Musculoskeletal News Roundup 28-Apr-11
BY LAUREN UZDIENSKI, APRIL 28, 2011
Earnings
CONMED reported 1Q:11 revenues of $183.5 million, up 4% over the year-ago period and beating estimates by $1.6 million. Among segments, arthroscopy sales increased by 5%, and powered surgical instruments increased by 9%. Non-GAAP diluted EPS was $0.37, up 32% from $0.28 in 1Q:10 and beating estimates by $0.06.
Integra LifeSciences reported 1Q:11 revenues of $181.0 million, up 4% over the year-ago period and beating estimates by $0.1 million. Orthopedics sales increased by 3% to $72.2 million. Growth rates exclude the effects of currency. Adjusted net income for the quarter was $20.0 million, or $0.66 per diluted share, compared to $19.0 million, or $0.63 per diluted share, in 1Q:10. EPS beat estimates by a penny.
Genzyme announced 1Q:11 revenues of $1.0 billion, up 7% over the year-ago period. Sales of Synvisc and Synvisc-One were $95.3 million during the quarter,up 20% over the year-ago period. The company noted that Synvisc was launched in Japan, "the largest market in the world for viscosupplements," in December, and "first-quarter sales there exceeded expectations."
MiMedx, a manufacturer of biomaterial-based products and bioimplants processed from human amniotic membrane, reported 1Q:11 revenues of $1.0 million, up from $0.1 million in 1Q:10. The company attributed the growth to sales from its amniotic membrane biomaterial platform, which is obtained through its acquisition of Surgical Biologics. Net loss for the quarter was $3.3 million, or $0.05 per diluted common share, which increased by $0.2 million over the year-ago period.
RTI Biologics reported 1Q:11 revenues of $40.6 million, up 8% over the year-ago period and beating estimates by $2.3 million. Highlights for the quarter included 13% sales growth in the company's sports medicine business. RTI reported net income of $1.2 million, or $0.02 per fully diluted share, in line with estimates.
Synthes reported 1Q:11 sales of $983.0 million, up 6% over the year-ago period and missing estimates by $7.0 million. The company said that global trauma sales "remained solid" on account of "new product launches and targeted field initiatives . . . [and] despite the impact of a mild winter in 2011 vs. a strong winter in Q1 of 2010 in Europe." Additionally, the company said that "challenging market dynamics" continued to affect spine sales. The company does not report sales by product segment, but by geography, North America sales increased by 5%; Europe increased by 3%; Asia Pacific increased by 19%; and ROW was up 8%. Growth rates exclude the effects of currency.
Zimmer reported 1Q:11 revenues of $1.1 billion, up 3% over the year-ago period and beating estimates by $22.2 million. Among segments, recon sales increased by 2%, with knee down by 1%, hip up by 5% and extremities up by 11%. Additionally, dental was up by 21%; trauma was up by 14%; and spine was down by 6%. Growth rates exclude the effects of currency. President and CEO David Dvorak said that the company "demonstrated continued progress toward our goal of consistently achieving growth at or above market rates in all of our geographies and businesses." Adjusted net earnings for the quarter were $230.9 million, or $1.19 per share, up 17% over the prior year and beating estimates by $0.07.
M&A
J&J announced that the company would buy Synthes for $21.3 billion (CHF 159 per share), a 9% premium to yesterday's close and a 22% premium to Synthes' stock price on April 15th, the day before the news broke that the two companies were negotiating an acquisition. The majority of the transaction (65%) will be funded with stock; the remainder will be cash. The deal is expected to close in 1H:12, with the long period to closing likely attributable to anti-trust concerns.
Regulatory
Biomet received 510(k) clearance of its Active Articulation E1 Dual Mobility Hip System, which the company says "[merges] the concept of dual mobility with the benefits of Biomet's exclusive E1 Antioxidant Infused technology and a proven cup design."
K2M received 510(k) clearance to market the EVEREST Degenerative Spinal System, a top-loading polyaxial pedicle screw system that can accommodate multiple levels of fixation rigidity. The system provides for both titanium and cobalt chrome rods of two different diameters.
MedShape Solutions received CE mark clearance for the Morphix Anchor, a suture anchor manufactured from MedShape's shape-memory PEEK Altera, and the ExoShape Interference Fixation Device, also made from PEEK Altera.
ORTHOCON received regulatory clearance to market its HEMASORB Absorbable Bone Hemostat Matrix in Europe and Canada. The company describes HEMASORB as a "ready-to-use, biocompatible, water-resistant and absorbable putty designed to rapidly stop bleeding when applied to damaged or cut bone."
SI-BONE announced that the FDA cleared a "major modification" to the existing product label designed to differentiate the product from fracture fixation devices. The the indications for use statement now reads, "The SI Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis, as the Agency believed this is more in line with the true intent of SI Joint Fusion System."
Vexim obtained Canadian ISO certification, which the company notes means that their SpineJack VCF treatment is in compliance with the Canadian regulatory quality system requirements. Vexim adds that the certification "paves the way for [SpineJack's] commercialization in Canada."
Product Introduction and Update
DJO Global announced the implantation of what they describe as the "first blended vitamin E total knee replacement in the U.S." The e-plus total knee replacement insert component was developed by DJO Surgical, formerly Encore Medical.
Exactech launched the Equinoxe Fx Plate to the company's Equinoxe Platform Shoulder System. The company says the plate offers multiple screw/blade configurations and instrumentation to treat a range of proximal humerus fractures and suit a number of surgical technique preferences. Additionally, the press release notes that the product's contoured design allows suture placement after the plate is secured.
Wright Medical announced the full commercial launch of FUSIONFLEX Demineralized Moldable Scaffold, which the company describes as a demineralized bone matrix made from 100% allograft. It is designed for use in conjunction with hardware in primary fusion procedures of the lower extremities, as well as other orthopedic bone grafting applications.
Clinical
Kuros announced that KUR-113, a paste that consists of a fibrin sealant combined with a variant of parathyroid hormone, met the primary efficacy endpoint in a randomized 200-patient phase IIb study designed to measure safety and efficacy of KUR-113 when used to treat open tibial shaft fractures. The primary endpoint of the study was healing at six months, comparing KUR-113 in combination with standard of care to standard of care alone.
SpinalMotion began enrollment in an international clinical study evaluating the Kineflex CI cervical artificial disc, which the company says is designed to optimize MRI imaging following disc implantation. The product features a core made from ceramic and endplates made primarily from PEEK, which would not create MRI interference.
Legal
Genzyme has filed two new lawsuits relating to its Synvisc-One HA product: the first is a follow-up to a suit filed last month against Seikagaku and Zimmer, who distributes Seikagaku's Gel-One HA product in the U.S. The second suit alleges that Anika's Monovisc, an HA treatment that is currently under FDA review, infringes a Genzyme patent.
Licensing and Distribution
Kuros regained the rights to its KUR-111, KUR-113 and KUR-115 technologies from Baxter. KUR-111 is an autograft replacement candidate that consists of a fibrin matrix, variant parathyroid hormone (PTH) and hydroxyapatite/calcium phosphate granules; KUR-113 comprises fibrin matrix and a variant PTH and is designed to promote bone formation and accelerate fracture repair; and KUR-115 is in the pre-clinical stage and will evaluated for use in spinal fusion. Kuros and Baxter will continue to co-develop KUR-211, which is currently in Phase II development in Europe in patients with diabetic foot ulcers.
Misonix entered into a three-year exclusive distribution agreement with Instrumentacion, S.A., based in Bogota, Colombia. Instrumentacion will sell and distribute the company's SonaStar Ultrasonic Surgical Aspirator and the BoneScalpel Ultrasonic Bone Cutter throughout Colombia. The agreement includes annual minimum purchase requirements.
Appointments
Alphatec Spine announced the appointment of Patrick Ryan as the Company's Chief Operating Officer. Mr. Ryan joins the Company from Abbott Vascular Devices, where he has been the Vice President, North Asia since August 2010.
