Musculoskeletal News Roundup 5-Mar-09
BY LAUREN UZDIENSKI, MARCH 5, 2009
Earnings
Alphatec Spine reported consolidated revenues for 4Q:08 of $28.4 million, an increase of 33% from the $21.3 million reported for 4Q:07. U.S. revenues for 4Q:08 were $22.0 million, an increase of 29% from the $17.1 million reported for 4Q:07. Asian revenues for 4Q:08 were $4.8 million, an increase of 13% from the $4.3 million reported for 4Q:07. European revenues for 4Q:08 were $1.6 million. There were no European revenues for 4Q:07. Net loss for 4Q:08 was $5.1 million, or $0.11 per share (basic and diluted), compared with a net loss of $11.2 million, or $0.24 per share (basic and diluted) for 4Q:07.
Anika Therapeutics reported 4Q:08 revenue of $9.0 million, missing estimates by $1.7 million and representing a 1% decrease over the year-ago period. Product sales were $8.3 million, up 5% over 4Q:07, which the company said was driven by growth in sales of Orthovisc and Monovisc. Sales of joint health products totaled $5.1 million, a 9% increase over 4Q:07. Net income for the quarter was $1.1 million, or $0.10 per diluted share, missing estimates by $0.03 and down 35% from 4Q:07, which the company attributed to higher operating expenses and lower interest income.
Greatbatch Inc. reported 4Q:08 revenues of $146.6 million, a 74% increase over 4Q:07. The increase was attributed in part to acquisitions. Organic growth was 10%. Net income for the quarter was $8.5 million, or $0.36 per share, up 200% from $2.8 million, or $0.12 per share, a year ago.
Integra LifeSciences reported 4Q:08 revenues of $174.4 million, reflecting an 11% increase over 4Q:07 and missing estimates by $0.7 million. Adjusted net income for 4Q:08 was $15.5 million, or $0.53 per diluted share, flat compared to 4Q:07 and missing estimates by $0.03. Integra Orthopedics, including the acquired Theken Spine business, reported $62.8 million in revenues, a 40% increase over 4Q:07.
Osteotech reported 4Q:08 revenues of $24.6 million, representing a 1% decrease over 4Q:07 and in line with estimates. The revenue decline was attributed to an expected reduction in private label Demineralized Bone Matrix (DBM) revenue of $2.6 million. Net loss for 4Q:08 narrowed to $0.41 million, or $0.02 per diluted share, down from $0.81 million in 4Q:07. EPS was in line with estimates.
Funding
Massachusetts-based NuOrtho Surgical received $1.0 million in financing from private investors, which it plans to use to support the commercialization and launch of its line of probes to be used in knee and shoulder procedures. The company says the probes cause less tissue damage than similar products.
Regulatory
Amedica received an FDA warning letter after the company allegedly promoted its Valeo-C vertebral body replacement device off-label.
Small Bone Innovations, Inc. received an Approvable Letter for the Scandinavian Total Ankle Replacement system (S.T.A.R. Ankle), allowing the company to proceed through the final steps of device approval. This includes an FDA inspection of the company's manufacturing facility.
Product Introduction and Update
Smith & Nephew launched a metal liner option for its R3 Acetabular System, which is designed for use in total hips and the Birmingham Hip Resurfacing procedure. Other liner options for R3 system include a cross-linked polyethylene for use in total hip replacements.
VG Innovations, Inc. launched the Directional Instrument System for Minimally Invasive Spine Surgery (DISMISS) for use in the implantation of the VerteLoc system. According to the company, the instruments are smaller in diameter than a pencil, and in addition to the smaller size of instruments, DISMISS allows the procedure to be performed with fewer instruments as well.
Appointments
Orthovita, Inc. appointed William Tidmore Chairman of the Board of Directors effective March 3, 2009, following the March 1 resignation of David Fitzgerald as Chairman. Mr. Tidmore has served on the Board since 2007 and was formerly President and Chairman of DePuy Acromed, as well as President of DePuy.
Miscellaneous
Orthofix International sent a letter to its shareholders ahead of its April 2 Special Meeting of Shareholders opposing Ramius LLC's proposals, which include replacing four Board members.
