Musculoskeletal News Roundup 6-Aug-09
BY LAUREN UZDIENSKI, AUGUST 6, 2009
Earnings
Alphatec Spine, Inc. announced financial results for FQ2:09. Consolidated revenues for the second quarter 2009 were $32.3 million, an increase of 35% from 2Q:08 and an increase of 5% over first quarter 2009. Adjusted EBITDA reached $2.8 million in the second quarter 2009, reflecting strong operating leverage. Highlights for the quarter include the completion of a $10.0 million private placement of common stock; the submission of a 510(k) application to the FDA for the OsseoScrew Expandable Pedicle Screw System; and the receipt of conditional FDA approval to initiate OsseoFix Spinal Fracture Reduction System US 510(k) clinical study.
Integra LifeSciences reported 2Q:09 revenues of $165.7 million, representing an 8% increase over the year-ago period and missing estimates by $0.5 million. Orthopedic revenue for the quarter was $65.2 million, up 28% over 2Q:08. Adjusted net income for 2Q:09 was $15.0 million, or $0.51 per diluted share, up from $14.1 million, or $0.49 per diluted share, in 2Q:08 and beating estimates by $0.02.
MAKO Surgical reported 2Q:09 revenues of $14.9 million, up from $0.7 million in 2Q:08 and beating estimates by $3.9 million. There were 358 MAKOplasty procedures in 2Q:09, a 35% increase over 1Q:09 and a 156% increase over 2Q:08. Net loss for 2Q:09 was $6.4 million, or $0.26 per basic and diluted share, narrowing from a net loss of $7.6 million, or $0.42 per basic and diluted share, in 2Q:08. Net loss was in line with estimates.
Orthovita reported 2Q:09 revenues of $24.5 million, representing a 27% increase over 2Q:08 and beating estimates by $1.6 million. The company attributed the revenue growth largely to the launch of Vitoss Bioactive Foam. Cortoss received FDA clearance during the quarter, but the period included no sales of that product, which was officially launched in July. Net loss for 2Q:09 was $0.7 million, or $0.01 per common share, narrowing from a net loss of $3.6 million, or $0.05 per common share, in 2Q:08. Analysts had forecast a loss of $0.02 for the quarter.
Symmetry Medical reported 2Q:09 revenue of $101.0 million, representing an 8% decrease from 2Q:08 and missing estimates by $4.8 million. Instrument sales were up 4%; implants were down 4%; and cases were down 19%. Net income for 2Q:09 was $9.0 million, or $0.25 per diluted share, up from net income of $6.2 million, or $0.17 per diluted share, in 2Q:08. EPS beat estimates by $0.04.
Wright Medical reported 2Q:09 revenues of $118.9 million, up 3% over 2Q:08 and missing estimates by $4.2 million. Among segments, hip increased by 2%; knee decreased by 1%; extremities increased by 19%; and biologics decreased by 4%. All growth rates exclude the effects of currency. Adjusted net income for 2Q:09 was $7.1 million, down from $7.2 million in 2Q:08. Adjusted EPS, excluding stock-based compensation, was $0.11 in 2Q:08, down from $0.13 in 2Q:08 and missing estimates by $0.02.
Funding
UK-based Acrobot Acrobot raised an undisclosed amount of funding from return investors the London Technology Fund, Imperial Innovations Group plc and PUK Ventures. These firms have now invested more than GBP 3 million in Acrobot, which is developing a computer-assisted surgical platform for orthopedics procedures.
M&A
DJO Inc. acquired the Canadian distributors of its Chattanooga, Saunders, Empi and Cefar/Compex branded products in two separate transactions. The acquisitions closed August 4, 2009, and the company did not disclose terms for the acquisitions.
Product Introduction and Update
Osiris announced the creation of a new Biosurgery division that will develop culture-expanded stem cell lines with application for bone repair. The benefits of culture-expanded cells include alleviating supply constraints, allowing for potentially higher concentrations of desired cells and enabling the selection of particular cells to be delivered to the patient.
Titan Spine, LLC initiated a limited market release of its ENDOSKELETON TT system, a TLIF device that received FDA clearance in April. The product is indicated for use in adults with degenerative disc disease in the lumbar spine.
Reimbursement
CMS released its IPPS final rule for FY2010. Spine reimbursement rates increased, on average, 6%-8% compared to 2009; trauma rates increased by 3.8%; and hips and knees received a 4.4% increase compared to 2009. Each of these treatment categories fared better than the 2010 rates proposed three months ago.
Investigations
According to a quarterly filing, DePuy received a subpoena from the New Jersey attorney general in May seeking information on the company's financial relationships with investigators who conducted studies for DePuy Orthopaedics, Inc. and DePuy Spine, Inc.
