Musculoskeletal News Roundup 22-Apr-10
BY LAUREN UZDIENSKI, APRIL 22, 2010
Earnings
Genzyme reported 1Q:10 revenues of $1.07 billion, down 7% from the year-ago period and missing estimates by $0.07 billion. Synvisc sales were $79.5 million for the quarter, up 26% from 1Q:09, with sales growth driven by Synvisc-One. Non-GAAP net income was $99.3 million, or $0.37 per diluted share, beating estimates by $0.04 and down from $227.5 million, or $0.82 per diluted share, in 1Q:09.
Johnson & Johnson reported 1Q:10 revenues of $15.6 billion, flat over the year-ago period and in line with estimates. DePuy reported 1Q:10 sales of $1.5 billion, up 8% over the year-ago period. Among segments, hip sales were up 11%; knee was up 9%; spine was up 3%; and sports medicine was up 11%. Growth rates exclude the effects of currency. Adjusted net earnings for the quarter were $3.6 billion, and diluted EPS was $1.29, representing increases of 3% and 2%, respectively, beating estimates by $0.02.
Kensey Nash reported F3Q:10 revenues of $19.9 million, down 5% from the year-ago period and beating estimates by $0.1 million. Orthopedic sales were $7.4 million, down 1% from FQ3:09, which the company attributed to the "slowdown in the orthopedics market." Diluted EPS was $0.46, up 10% from the year-ago period and beating estimates by a penny.
NuVasive reported 1Q:10 revenues of $109.1 million, up 36% over the year-ago period and beating estimates by $0.9 million. The company attributed the sales increase to "continued adoption of the XLIF technology, stronger traction from new product launches and [...] the positive reimbursement progress during the quarter." The company reported non-GAAP earnings of $8.3 million, or $0.21 per share, in line with estimates.
Orthovita reported 1Q:10 revenues of $24.1 million, up 11% and missing estimates by $1.3 million. Vitomatrix, a bone graft material used in dental applications, contributed $0.2 million to the quarter's sales, and Cortoss contributed $0.9 million in sales; neither product was available in 1Q:09.
Stryker reported 1Q:10 revenues of $1.8 billion, up 9% from the year-ago period and beating estimates by $51.0 million. Orthopedic implant sales increased 6% to $1.1 billion, with hip up 4%, knee up 8%, trauma up 11% and spine up 8%. Growth rates exclude the effects of currency. Diluted EPS increased by 13% to $0.80 in 1Q:10, beating estimates by $0.02.
Zimmer reported 1Q:10 revenues of $1.1 billion, up 3% over the year-ago period and in line with estimates. Recon sales increased 3% to $815.0 million, with knee up 4%, hip up 1% and extremity up 14%. Additionally, dental sales increased 6%, trauma increased by 3% and spine declined by 9%. Growth rates exclude the effects of currency. Adjusted EPS was $1.02 for 1Q:10, up 7% over the year-ago period and beating estimates by a penny.
Funding
Internal Fixation Systems, a manufacturer of "generically-priced" trauma implants, raised $0.5 million in a bridge financing from unnamed investors as well as an unspecified amount from Alienware Corp. founder Alex Aguila. The company is planning to raise a second round in 2Q:10. IFS says they can produce devices "equivalent in quality, design, functionality and material" to competitor devices while charging 40-60% less.
Soft Tissue Regeneration raised $0.5 million from Connecticut Innovations as part a planned $3.5 Series A round announced last year. The company is developing a synthetic braided scaffold for the treatment of ACL injuries and will use the funds to complete large-animal testing and begin a clinical study.
Regulatory
Smith & Nephew received 510(k) clearance for additional claims related to their VERILAST technology for knee replacements, a combination of the company's OXINIUM material and a cross-linked polyethylene. The company reports that VERILAST can "provide wear performance sufficient for 30 years of actual use under typical conditions."
Product Introduction and Update
Interventional Spine announced the first commercial use in the U.S. of the RENEW device, an interspinous process device made from allograft and indicated for the treatment of lumbar stenosis.
Magen Medical announced that the first three patients have been treated in the company's first-in-human, single-center, prospective feasibility study to assess the safety and efficacy of the SpineShield, a metal anti-adhesion device designed to prevent scar tissue formation following hemilaminectomy. The study is being conducted at the Bagdasar Arseni Emergency Hospital in Bucharest, Romania.
Intellectual Property
minSURG received a U.S. patent covering its TruFuse procedure, a minimally-invasive facet fusion treatment.
Legal
NuVasive initiated a "legal dispute" against Orthofix over IP related to Osteocel, the stem-cell-based bone graft substitute acquired by NuVasive from Osiris in 2008. The details of this dispute were not revealed, but NuVasive vowed to "aggressively defend" their rights to Osteocel, which analysts estimate brought in about $35 million in revenue in 2009.
Clinical
LDR completed two-year follow-up for its IDE study evaluating the use of Mobi-C cervical artificial disc at two levels. The one-level study was completed in 2008, and the company notes that they are the first to "fully enroll and reach two-year follow-up on a concurrent one-level and two-level cervical artificial disc replacement study." LDR is now preparing the PMA for the device and expecting approval in 2011.
Appointment
TranS1 appointed Joseph Slattery Executive Vice President and Chief Financial Officer. In conjunction with his appointment, Mr. Slattery resigned his position as a TranS1 Director and Chairman of the Audit Committee. Previously, Mr. Slattery served as Chief Financial Officer and Senior Vice President of Finance and Information Systems of Digene Corporation.
