Musculoskeletal News Roundup 4-Nov-10
BY LAUREN UZDIENSKI, NOVEMBER 4, 2010
Earnings
aap Implantate reported 3Q:10 sales of EUR 7.2 million ($9.8 million), representing a 20% increase over 3Q:09. The company is continuing to focus its sales strategy on orthopedics, trauma and spine. EBITDA increased to EUR 1.0 million ($1.4 million) in 3Q:10 from EUR 0.3 million ($0.4 million) in 3Q:09.
ArthroCare reported 3Q:10 revenues of $87.9 million, representing an 11% increase over 3Q:09 and beating estimates by $1.4 million. Sports medicine contributed $57.0 million to revenues, with sales in that segment up by 13%. Spine was down by 4% to $4.3 million. Net income for 3Q:10 was $8.4 million, or $0.25 per diluted share, which compares to a net loss of $31.7 million, or $1.18 per share, in 3Q:09. Analysts had forecast EPS of $0.20.
DJO reported 3Q:10 sales of $233.6 million, representing a 1% increase over the year-ago period on a pro forma basis. As reported, bracing and supports sales increased by 2% during the quarter; recovery sciences sales were flat; and surgical implant sales were down by 6%. The company reported a net loss for the quarter of $7.7 million, which compares to a net loss of $11.4 million in 3Q:09.
Exactech announced 3Q:10 revenue of $42.0 million, down 1% from the year-ago period and in line with a pre-announcement. Among segments, knee was down 10%; extremity was up 33%; hip was down 3%; and biologic and spine sales were down 3%. Exactech Chairman and CEO Bill Petty said, "Softness in several lines of our business was exacerbated by the temporary negative impact of costs associated with entry into new markets and distribution channel changes internationally." Adjusted net income for 3Q:10 was $1.6 million, or $0.12 per share. Analysts had forecast EPS of $0.20.
MAKO Surgical reported 3Q:10 revenue of $12.0 million, representing a 79% increase over the year-ago period and missing estimates by $0.7 million. Nine RIO systems were installed during the quarter, bringing the company's total installed base to 54 systems. Additionally, 815 MAKOplasty procedures were performed during the quarter. Net loss for the quarter was $8.9 million, or $0.27 per share, which compares to a net loss of $9.4 million, or $0.33 per share, in 3Q:09. EPS missed estimates by $0.04.
Orthovita reported 3Q:10 sales of $23.3 million, up 5% from the year-ago period and in line with a pre-announcement. Among product segments, Vitoss sales increased by 1%, and biosurgery sales increased by 4%. Cortoss sales were $1.0 million during 3Q:10, compared to $0.4 million in 3Q:09, when the product was launched. Net loss for 3Q:10 was $0.3 million, or $0.00 per common share, which compares to a net loss of $1.7 million, or $0.02 per common share, in 3Q:09 and is in line with estimates. The company attributed the improvement in net loss to cost reduction efforts implemented in June 2010.
Osteotech reported 3Q:10 sales of $23.1 million, which includes $3.0 million from new products (primarily MagniFuse Bone Graft and Plexur M Innovative Grafting). Sales were flat over 3Q:09 and in line with the estimate from the sole analyst covering the stock. Net loss for the quarter was $2.5 million, or $0.14 per share, which compares with a net loss of $1.9 million, or $0.11 per share, in 3Q:09.
RTI Biologics reported 3Q:10 sales of $41.8 million, down 3% over 3Q:09 and beating estimates by $0.4 million. Among segments, sports medicine sales increased by 15%; spine decreased by 10%; dental increased by 11%; and bone graft substitutes and general orthopedic sales declined by 3%. Net loss for 3Q:10 was $133.1 million, or $2.43 per share, which compares to net income of $2.3 million, or $0.04 per share, in 3Q:09. The net loss during the quarter was attributed to a non-cash goodwill impairment charge. Adjusted net income was $1.6 million, or $0.03 per share. Analysts were expecting EPS of $0.26 for the quarter.
Smith & Nephew reported 3Q:10 revenues of $941.0 million, up 4% over the year-ago period and beating estimates by $12.0 million. Orthopedics sales grew by 2% to $510.0 million, with hip flat, knee up 6%, trauma up 5% and clinical therapies down by 5%. Adjusted EPS was $0.16, beating estimates by a penny.
Symmetry Medical reported 3Q:10 revenues of $91.5 million, representing a 5% increase over the year-ago period and beating estimates by $5.6 million. The company said sales growth "reflects improved customer demand in the company's orthopedic and medical device businesses." Net income for 3Q:10 was $3.6 million, or $0.10 per diluted share, which compares to $5.4 million, or $0.15 per diluted share, in 3Q:09. Analysts had forecast EPS of $0.17.
TiGenix announced that ChondroCelect revenues amounted to EUR 0.2 million ($0.3 million) during 3Q:10, with sales coming from Belgium, the United Kingdom and the Netherlands "under a variety of pre-reimbursement payment mechanisms" as well as initial reimbursements by German health insurance funds. The company also reported an additional EUR 0.6 million ($0.8 million) in grant revenues.
Funding
MAKO Surgical has priced a public offering of 5,500,000 shares of its common stock at a price to the public of $9.65 per share. Piper Jaffray & Co. acted as the sole underwriter for the offering, which is expected to take place on or about November 8, 2010. The company plans to use the proceeds from this offering to support commercialization, sales, marketing and general administrative activities, for research and product development activities and to fund working capital and other general corporate purposes.
Xylos received a $0.2 million grant from the U.S. Qualifying Therapeutic Discovery Project (QTDP) Program, which the company will use to develop its biocellulose biomaterial technology.
Regulatory
ArthroCare received 510(k) clearance to market its SpeedFix Suture Anchor system, which consists of a push-in anchor made of PEEK and is designed for the repair of certain tears of the labrum in the shoulder.
Bioretec received CE mark clearance for CiproScrew, a bioabsorbable, antibiotic-releasing screw implant. The company says it is indicated for complicated fractures, osteotomies, arthrodeses and in the fixation of bone fractures in patients when infection is a potential risk.
NeoStem announced that a local Chinese reimbursement authority approved the pricing for an arthroscopic autologous adult stem cell-based treatment being administered at Wendeng Orthopedic Hospital, which the company describes as "one of the leading specialist orthopedic hospitals in China." Patients are eligible to receive reimbursement for up to 80% of the cost of the procedure under the new technology category.
Product Introduction and Update
Salient Surgical announced that 500,000 patients have been treated using the company's TRANSCOLLATION technology. The device uses radiofrequency (RF) energy and saline to provide hemostatic sealing of soft tissue and bone during surgery.
Intellectual Property
Interventional Spine received U.S. Patent No. 7,824,429, entitled Method and Apparatus for Spinal Fixation, which covers the company's percutaneous transfacet-pedicular compression system for posterior spine fixation. This technology is sold under the PERPOS PLS System name and includes the company's BONE-LOK implant.
Legal
A federal judge in California ruled that CareFusion failed to prove that Medtronic violated anti-trust regulations in the marketing of their vertebroplasty and kyphoplasty products. If CareFusion opts to continue the suit, they have one month to file an amended complaint.
Appointments
CareFusion announced that Chairman and CEO David L. Schlotterbeck will retire on February 28, 2011. The company has begun its process for identifying a successor, whom they plan to have in place before Mr. Schlotterbeck retires in February.