Musculoskeletal News Roundup 23-Apr-09
BY LAUREN UZDIENSKI, APRIL 23, 2009
Earnings
CONMED reported 1Q:09 revenues of $164.1 million, representing a 7% decrease over 1Q:08 and missing estimates by $9.5 million. Arthroscopic devices contributed $63.9 million in revenue, down 8% over 1Q:08, with the decline due largely to a 24% decrease in capital equipment purchases. Endoscopic technology revenues increased 2%. Growth rates are constant currency. Non-GAAP diluted earnings per share equaled $0.19, missing estimates by $0.05.
Genzyme reported 1Q:09 revenue of $1.15 billion, representing a 4% increase over 1Q:08 and missing estimates by $50.0 million. Synvisc sales, which should be bolstered this year with the upcoming U.S. launch of Synvisc-One, increased 13% to $63.2 million. Non-GAAP net income was $288.1 million, or $1.04 per diluted share, representing a 10% increase over 1Q:08 and missing estimates by a penny.
Kensey Nash's FQ3:09 revenues were flat at $20.6 million and missed estimates by $1.0 million. Sales of orthopedic products were also flat at $7.7 million. Royalty revenue from Orthovita was $1.4 million, a 27% increase over FQ3:08. Net income was $4.9 million, or $0.42 per share, beating estimates by $0.03.
NuVasive reported 1Q:09 revenues of $80.0 million, reflecting a 56% increase over 1Q:08 and a 7% sequential increase and beating estimates by $5.2 million. For 1Q:09, the company reported a net loss of $4.3 million, or $0.12 per share; non-GAAP net income was $7.3 million, or $0.19 per share. Analysts had forecast a loss of $0.20 per share. The company also raised revenue guidance from $345-$350 million to $355-$360 million.
Stryker reported 1Q:09 revenue of $1.6 billion, missing estimates by $30 million. Orthopedic implant revenue contributed $973.0 million, a 6% increase over 1Q:08. Among segments, hip increased 6%, knee 6%, trauma 8% and spine 11%. All growth rates are constant currency. Net income for the quarter was $281.0 million, or $0.71 per share, in line with estimates and reflecting a 3% decrease over 1Q:08.
Zimmer reported 1Q:09 revenues of $993.0 million, representing a 2% decrease over the year-ago period and missing estimates by $7.0 million. Recon contributed $762.0 million, a 1% decrease over 1Q:08; knee growth was flat, hip decreased 4% and extremity increased by 8%. Additionally, trauma sales increased 5% and spine by 24%. Dental decreased by 11%. All growth rates are constant currency. Adjusted net earnings were $210.0 million, with adjusted EPS of $0.95, which missed estimates by a penny.
M&A
NuVasive announced plans to acquire Cervitech for $47.0 million plus an additional $33.0 million in payments contingent on FDA approval of Cervitech's PCM cervical disc. Cervitech's IDE study will conclude later this year, and NuVasive plans to submit the PMA for approval in 1Q:10, with a product launch projected for 2011.
Funding
Azellon, a company formed out of the University of Bristol, raised GBP 1.6 million ($2.3 million) to develop an autologous stem cell treatment for meniscal tears. Investors include the Wellcome Trust, the Technology Strategy Board, IP Group, the Wyvern Fund, Oxford Technology Management and the Universities of Bristol and Bath. Funds will be used for pre-clinical and clinical studies, with the latter targeted to begin in 2010.
Sonoma Orthopedics raised $12.0 million to commercialize the WaviBody, a flexible fixation device that becomes rigid after being inserted into a fracture. Applications for the device include treatment for clavicle and wrist fractures. The round was led by Split Rock Partners, who were jointed by Asset Management, EDF Ventures and MedVenture Associates.
Regulatory
Magellan Spine Technologies received the CE mark for the company's DART Disc Annular Repair Technology System, which is used following a lumbar microdiscectomy to seal the access site in the annulus.
Product Introduction and Update
ReGen Biologics announced the completion of the first U.S. commercial implantation of its Menaflex collagen meniscus implant. The surgery was performed by David Caborn, M.D. at Jewish Hospital & St. Mary's HealthCare in Louisville, Kentucky.
VG Innovations, Inc. launched VerteLoc in Europe. The device is a spine stabilization system targeting the facet joints.
Legal
Orthofix is facing two whistleblower lawsuits in the U.S. District Court for Massachusetts, according to court documents unsealed last week. The first concerns sales versus rentals of bone growth stimulation devices, and the second concerns alleged improper payments by Blackstone Medical to physicians.
Intellectual Property
Eden Spine received a U.S. patent for its WellDisc lumbar disc prosthesis. The device "controls segmental motion and restores the guiding function of the facets while decreasing their loading," according to Dr. Jean-Philippe Lemaire, who helped develop the device.
Clinical
Facet Solutions, Inc. announced one-year results from its ACADIA Facet Replacement System U.S. pilot study, which evaluates the device for the treatment of lumbar spinal stenosis. Results included an 88% reduction in ODI, a 77% reduction in reported back pain and an 83% reduction in reported leg pain. There were no device-related adverse events. The data will be presented at next week's Spine Arthroplasty Society meeting in London.
Interventional Spine announced the completion of the first procedure with the PDS System as part of the company's IDE study. The device is designed as an alternative to fusion for the treatment of DDD in the lumbar spine.
