Musculoskeletal News Roundup 4-Aug-11
BY LAUREN UZDIENSKI, AUGUST 4, 2011
Earnings
In 2Q:11, Alphatec Spine achieved revenue of $50.9 million, which represented growth of 12% versus 2Q:10. U.S. revenue of $34.5 million reported for 2Q:11 represented 18% growth over 2Q:10, driven by strength of core products and increase in purchase orders from hospitals for Alphatec Spine products. Cash flow was break-even in the second quarter 2011, reflecting strong revenue growth, working capital management and operating expense control.
Anika Therapeutics reported 2Q:11 revenue of $16.1 million, up 11% over the year-ago period. The company said that sales growth "reflected continued strong U.S. sales of Orthovisc." Net income for the quarter was $2.3 million, or $0.17 per diluted share, which compares to $1.1 million, or $0.08 per diluted share, in 2Q:10.
ArthroCare reported 2Q:11 revenues of $91.3 million, up 5% over the year-ago period and missing estimates by $1.1 million. Sports medicine sales increased by 4% to $57.2 million. Net income for the quarter was $11.5 million, or $0.34 per diluted share, which compares to compared to $7.3 million, or $0.22 per diluted share, in 2Q:10. EPS was in line with estimates
BioMimetic Therapeutics announced 2Q:11 revenues of $0.44 million, up 19% over the year-ago period and missing estimates by $0.11 million. The company noted that they are anticipating a letter from the FDA outlining post-panel requirements for PMA approval of Augment around September. BMTI reported a net loss of $8.2 million, or $0.29 per diluted share, for 2Q:11, which compares to a net loss of $7.7 million, or $0.35 per diluted share, in 2Q:10. Analysts had forecast a net loss of $0.33 per share.
Exactech reported 2Q:11 sales of $51.7 million, up 9% increase over the year-ago period and beating estimates by $0.1 million. Among segments, knee sales increased by 7%; extremity increased by 36%; hip increased by 15%; and biologic and spine sales decreased by 13%. Adjusted net income for the quarter increased 13% to $3.7 million, or $0.28 per share. EPS beat estimates by $0.02.
On July 28th, Sanofi Aventis reported 2Q:11 earnings. Synvisc sales increased by 17% to EUR 89.0 million ($128.1 million). The company attributed the sales growth to the recent launch in Japan and sales of Synvisc One.
Smith & Nephew reported 2Q:11 revenues of $1.1 billion, up 5% over the year-ago period and beating estimates by $19.0 million. Orthopedics sales increased by 4% during the quarter to $588.0 million. Recon was up 3%, with hip flat and knee up by 7%. Trauma sales increased by 4%. Clinical therapies sales increased by 6%. In the endoscopy segment, arthroscopy sales grew by 6%. Growth rates exclude the effects of currency. Adjusted earnings per share increased by 6% to $0.18, in line with estimates.
Symmetry reported 2Q:11 revenues of $94.7 million, up 7% over the year-ago period and missing estimates by $1.0 million. The company attributed the revenue growth to increased customer shipments in the instruments and cases businesses. Non-GAAP net income increased 19% to $5.6 million, or $0.16 per share, beating estimates by $0.02.
Funding
Bacterin secured a 42-month credit facility from MidCap Financial LLC and Silicon Valley Bank that provides a line of credit up to $15.0 million. Proceeds will be used to reduce debt and for working capital and potential future acquisitions.
Ellipse Technologies raised $17.6 million in a series C funding round led by HBM BioVentures and BioStar Ventures, who were joined by Wexford Capital and the MedFocus Funds. The company says the funds will enable Ellipse to initiate commercialization of the MAGEC and expand into new markets. The MAGEC system (MAGnetic Expansion Control) is an orthopedic deformity prevention and management technology that allows implanted devices to be adjusted from outside the body by remote control.
Reimbursement
CMS released their IPPS final rule for FY2012 this week. Hip and knee replacements and spine fusion payments will be relatively flat, while trauma and vertebral augmentation payments should increase by about 6%. Final payment rates are in line to slightly above proposed rates in April.
Intellectual Property
MedShape Solutions has been granted a U.S. patent covering "Osteosynthetic Implants, Methods of Use and Manufacture." According to the company, their shape memory technology allows for the application of compressive pressure across the fracture site for longer periods of time than standard bone screws.
Legal
KFx Medical filed a patent infringement lawsuit in the U.S. District Court for the Southern District of California against Arthrex, Inc., alleging that Arthrex infringed a KFx patent covering the method of knotless double row rotator cuff repair.
Clinical
Medtronic provided a $2.5 million grant to Yale University to conduct two independent, third-party systematic reviews of Infuse. The company will provide Yale with all available Infuse study data, published and unpublished, as well as all FDA-filed adverse event reports. Yale will assemble a panel of experts and will commission two "academically-recognized, publicly- trusted clinical research organizations . . . to conduct the analyses and ensure the findings are reproducible and of the highest integrity." Additionally, all Medtronic's study data will be made available on ClinicalTrials.gov.
SI-BONE launched a clinical research and development to effort to "generate a substantial body of clinical and economic evidence for its iFuse Implant System." To support this initiative, the company has filed an IDE known as MISSION (Minimally Invasive Surgical iFuse Implant System in SI Joint FusiON).
Tornier announced that the first patient has been enrolled and treated in the IDE study for their Simpliciti stemless shoulder joint replacement system. The implant is stemless and preserves humeral bone. The company also announced that the Simpliciti system has been launched outside the U.S.
Distribution
Misonix entered into a new three-year exclusive distribution agreement with Osteotrauma Ltda., whereby Osteotrauma will sell and distribute the SonaStar Ultrasonic Surgical Aspirator and the BoneScalpel Ultrasonic Bone Cutter throughout Chile. The agreement includes annual minimum purchase requirements.
Appointments
Alphatec Spine announced that its Board of Directors elected Leslie H. Cross the non-executive Chairman of the Board of Directors. Mr. Cross recently retired as the President and Chief Executive Officer of DJO Global, Inc., a position he has held since 1995.
