Musculoskeletal News Roundup 30-Apr-09
BY LAUREN UZDIENSKI, APRIL 30, 2009
Earnings
aap Implantate reported 2008 revenues of EUR 31.9 million ($45.0 million), a 14% increase over 2007 sales. Sales in the Trauma & Orthopedics division grew by 35%. Biomaterials sales increased by 4%, with the company attributing slower growth to changes in customer behavior and regulatory delays. EBITDA decreased 28% to EUR 3.7 million ($5.2 million).
Anika Therapeutics reported 1Q:09 revenue of $8.5 million, representing an 8% increase over 1Q:08 and missing estimates by $0.8 million. Joint health revenues, including Orthovisc and Monovisc OUS, increased by 25%. Net income was $0.5 million, or $0.05 per diluted share, missing estimates by $0.04 and down from $0.6 million in net income in 1Q:08, which was attributed to the current "lower interest rate environment."
Exactech reported 1Q:09 revenues of $43.3 million, representing a 9% increase over the year-ago period and missing estimates by $0.5 million. Knee sales were flat over 1Q:08; hip increased 3%; biologic and spine revenue increased 7% and extremity increased 57%. Net income, excluding costs associated with a DOJ inquiry was $3.3 million, or $0.26 per share, representing a 12% increase over 1Q:08 and beating estimates by $0.05.
RTI Biologics reported 1Q:09 revenues of $38.6 million, representing a 29% increase over 1Q:08 and beating estimates by $1.0 million. Sales were impacted by the acquisition of Tutogen. Net income for the quarter was $1.0 million, or $0.02 per fully diluted share, in line with estimates.
Smith & Nephew reported 1Q:09 revenues of $865.0 million, representing a 4% increase over 1Q:08 and missing estimates by $22.0 million. Orthopedic products contributed $508.0 million in revenue, also reflecting a 4% increase over the year-ago period in what the press release called a "slowing market." Recon grew 3%, with knee reporting 5% revenue growth and hip up 2%. Trauma grew by 6%. Reported trading profit for the quarter was $183.0 million, a 12% increase over the year-ago period, with an in-line adjusted EPS of $0.13.
Synthes reported 1Q:09 sales of $805.0 million, representing a 10% increase over 1Q:08 (excluding the effects of currency) and missing estimates by $38.7 million. North American sales contributed $500.2 million, a 7% increase over 1Q:08, which the company said was affected by lower procedure volumes in the U.S.
Trans1 reported 1Q:09 revenues of $8.7 million, representing an increase of 45% over 1Q:08 and beating estimates by $1.1 million. There were 889 Trans1 procedures performed during the quarter. Net loss widened in 1Q:09 to $5.2 million from $2.4 million on account of higher operating expenses. Adjusted non-GAAP earnings were $0.22 per share, missing estimates by $0.10.
Wright Medical reported 1Q:09 revenues of $120.9 million, representing a 4% increase and missing estimates by $1.6 million. Among segments, hip sales increased 5%; knee increased 1%; extremity increased 27%; and biologics decreased 4%. 1Q:09 net income for the first quarter of 2009 totaled $3.3 million compared to $4.1 million in the year-ago period. Adjusted for one-time events, EPS were $0.20, beating estimates by $0.08.
Product Introduction and Update
DePuy Spine, Inc. launched the HEALOS Fx Injectable Bone Graft Replacement, which is designed specifically for minimally invasive spine surgery. The company describes HEALOS Fx as a "moldable, injectable version of HEALOS Bone Graft Replacement."
ETEX received 510(k) clearance for 1cc and 2.5cc sizes of Beta-bsm Injectable Paste and Gamma-bsm Moldable Putty. The company currently has 5cc and 10cc sizes on the market.
K2M debuted its injectable polymer technology, which was licensed for spinal applications from Promethean Surgical Devices, Inc. in 2008, at SAS this week. The company says the technology could have multiple applications in spine surgery, including nucleus replacement or annular decompression and repair.
Clinical
Apatech released new clinical data on its Actifuse product. Two fusion studies, one involving 38 patients with a diagnosis of lumbar stenosis and the other 69 patients with degenerative lumbar spine disease, both concluded that Actifuse offered clinical results and fusion rates that were comparable to autograft.
Facet Solutions, Inc. expanded its Acadia Facet Replacement System pivotal study to 12 U.S. sites. The device, which is designed for the treatment of lumbar spinal stenosis, "enables the surgeon to do a decompression and at the same time restore anatomic motion and stability to the lumbar spine."
ISTO Technologies, Inc. received FDA clearance to begin a Phase I clinical study for NuQu, which the company calls a "cell-based injectable formulation of juvenile chondrocytes designed to regenerate cartilage, restore disc function and relieve discogenic back pain."
Mesoblast received Australian regulatory clearance to begin a Phase 2 trial of its allogenic stem cell therapy product for cervical spinal fusion. The controlled study will randomize 24 patients for NeoFuse or autograft to evaluate safety and effectiveness of the Mesoblast product.
Operations
VG Innovations, Inc. is expanding its corporate and satellite offices to meet growing demand for its Verteloc device. The company says the average number of monthly Verteloc procedures has increased 293% and average monthly sales revenue has increased 266% compared with 2008.
Appointments
MAKO Surgical appointed Ivan Delevic to the position of Senior Vice President of Strategic Marketing and Business Development, where he will be responsible for MAKO's strategic marketing and business development initiatives. Prior to joining MAKO, Mr. Delevic was a business development consultant for various medical device companies and has held posts at General Electric Healthcare and Johnson and Johnson, Inc.
Scient'x Groupe, S.A. announced that veteran industry executive Oliver Burckhardt is joining the company as its President and Chief Executive Officer following the retirement from the Company of Michael D. Huggins. Mr. Burckhardt was formerly President of Orthofix Spine, Inc. and was responsible for the global Spine business units, where revenues exceeded US$100 million in 2008. Prior to Orthofix, Mr. Burckhardt was with Aesculap, where he served as the Vice President of Spine Sales and Marketing and played a key role in building the USA and international Aesculap spine business from start-up. His experience includes developing and commercializing spinal implants, M&A, initiating marketing strategies and establishing meaningful relationships with leading spine surgeons throughout the world.
