Musculoskeletal News Roundup 12-Aug-10
BY LAUREN UZDIENSKI, AUGUST 12, 2010
Earnings
aap Implantate reported 2Q:10 revenues of EUR 7.0 million ($8.5 million), down 13% over the year-ago period; adjusting for the divestiture of their analytics business, sales increased by 23% over 2Q:09. The company is planning to further acceleration of sales growth with new product launches and the introduction of existing products in new markets. EBITDA for 1H:10 was EUR 1.1 million ($1.3 million), improved from EUR 0.1 million ($0.1 million) in 1H:09.
Anika Therapeutics reported 2Q:10 revenues of $13.7 million, representing an increase of 56% over 2Q:09. Excluding sales from Fidia Advanced Biopolymers, revenues increased by 24%. The company attributed the sales performance to growth of the ORTHOVISC product line, both in the U.S. and internationally. Net income for quarter was $1.1 million, up 11% over the year-ago period. EPS was $0.08 per diluted share for both 2Q:10 and 2Q:09, with the company noting that 2Q:09 was adversely affected by the purchase of Fidia.
Osteotech reported 2Q:10 revenues of $24.0 million, representing a 2% increase over the year-ago period and missing the estimate of the sole analyst covering the stock by $0.2 million. The company noted that sales of new products, including MagniFuse, Plexur M and FacetLinx Fusion Technology, contributed $2.5 million to sales. Net income for 2Q:10 was $0.1 million, or $0.01 per diluted share, which compares to a net loss of $1.2 million, or $0.07 per share, in 2Q:09. EPS beat the estimate of the sole analyst covering the stock by $0.03.
Funding
Orthopedic devicemaker China Kanghui debuted on the New York Stock Exchange (NYSE: KH) on August 11, pricing its American depositary shares at the midpoint of its range at $10.25. The IPO raised $68.4 million.
Wales-based Orthos received GBP 0.8 million ($1.3 million) in funding from a combination of Finance Wales, Welsh Assembly Government and angel investments. The company will use the funds to bring its BetaGel synthetic bone substitute to market.
Regulatory
BioMimetic Therapeutics announced this morning that it has received orphan drug designation from the FDA for their PDGF technology in the treatment of osteochondritis dissecans (OCD) of the knee, elbow or ankle. Similar to an HDE designation for devices, orphan drugs address conditions affecting less than 200,000 people in the United States. The orphan drug designation can have a number of benefits, including an accelerated path to FDA approval, tax credits and seven years of market exclusivity.
Product Introduction and Update
Small Bone Innovations announced the first total wrist joint replacement surgery in Malaysia with the RE-MOTION Total Wrist System.
Zimmer Holdings announced the first implantation of the Zimmer NCB (Non-Contact Bridging) Periprosthetic Plating System, which is designed to address femoral fractures occurring around a hip or knee implant. The system is slated for full release in the fall of 2010.
Legal
Genzyme filed a patent infringement complaint against Anika Therapeutics over the manufacture of MONOVISC in the U.S. Anika said that "neither MONOVISC, nor its manufacture, does or will infringe any valid and enforceable claim of the asserted patents."
Operations
Orthofix opened its new North American Operations and Education Center in Lewisville, Texas on August 12th. The new facility will house the company's Global Spinal Implants and Spine Stimulation Divisions as well as its North American Orthopedics Division and consolidates operations from the company's New Jersey and Massachusetts sites.
