Musculoskeletal News Roundup 22-Oct-09
BY LAUREN UZDIENSKI, OCTOBER 22, 2009
Earnings
CONMED reported 3Q:09 sales of $175.5 million, down 2% from the year-ago period and beating estimates by $1.4 million. Arthroscopy sales were up 2% and powered instrument sales were flat. Non-GAAP diluted EPS of $0.28 beat estimates by $0.12.
Genzyme reported 3Q:09 sales of $1.06 billion, representing a 9% decline from the year-ago period and missing estimates by $50.0 million. Synvisc and Synvisc-ONE sales were $87.5 million for 3Q:09, representing a 30% increase over the year-ago period. Adjusted EPS for the quarter was $0.31, $0.13 below estimates.
Kensey Nash reported FQ1:10 revenues of $19.7 million, down from revenues of $20.1 million in the year-ago period and missing estimates by $0.7 million. Orthopedic sales were $6.4 million, down 19% from the year-ago period. Royalties from Orthovita were flat at $1.4 million; sports medicine was down by 10%; spine was down 27%; and sales of "other orthopedic" products were down by 61%. President and CEO Joe Kaufmann noted that, "We believe our net sales growth, particularly related to sports medicine products, will be negatively affected in the short-term by the reduction in elective procedures." He added that the company expects to see a turnaround in the second half of the fiscal year. EPS for the quarter was $0.43, beating estimates by $0.02.
Medicrea reported 3Q:09 sales of EUR 3.1 million ($4.5 million), representing an 82% increase over 3Q:08. The company attributes the sales growth to increasing penetration of the U.S. market, which now accounts for about half of the company's sales.
NuVasive reported 3Q:09 sales of $94.9 million, up 42% over the year-ago period and beating estimates by $2.0 million. Chairman and CEO Alex Lukianov noted, "We continue to take market share and expand our addressable market by broadening the application of our technology throughout the spine." Pro forma EPS for the quarter was $0.11, beating estimates by $0.06.
Stryker reported 3Q:09 sales of $1.65 billion, up 1% from 3Q:08 and beating estimates by $40.0 million. Among segments, orthopedic implant sales increase by 7% to $1.0 billion, with hip up 6%, knee up 7%, trauma up 6% and spine up 14%. All growth rates exclude the effects of currency. Adjusted net earnings were $277.0 million, or $0.69 per share, with EPS up 5% over the year-ago period and in line with estimates.
Synthes reported 3Q:09 sales of $868.3 million, up 10% from 3Q:08 and in line with estimates. By geography, North American sales increased by 10%; Europe by 13%; Asia Pacific by 20%; and ROW decreased by 12% over the year-ago period. All growth rates exclude the effects of currency.
Zimmer reported 3Q:09 sales of $976.0 million, up 4% over the year-ago period and beating estimates by $22.0 million. Among segments, reconstructive was up 2%, with hip flat, knee up 3% and extremity up 20%. Additionally, dental was down by 6%; trauma up 6%; and spine was up by 26%. All growth rates exclude the effects of currency. Adjusted EPS for the quarter was $0.88, down 9% over the year-ago period and beating estimates by $0.02.
M&A
Biomet acquired the assets of Cartilix for an undisclosed sum. Cartilix is developing ChonDux, which utilizes an adhesive and hydrogel to fill lesions in the articular cartilage. The product is not yet available for sale, with a clinical study scheduled to begin in Europe in 1H:10, with a U.S. study to follow.
MiMedx Group has sold the assets of its upper extremities business, LeveL Orthopedics, in separate transactions valued at over $1.0 million. The majority of the assets were sold to UPex Holdings, a design and distribution company that focuses on upper extremity orthopedic products.
Funding
BioCeramic Therapeutics raised GBP 1.2 million ($2.0 million) to support the 2010 launch of several of its products, including a bone graft substitute for orthopedic and dental applications. Investors include Imperial Innovations, Longbow Capital, Comvest Limited and the Esmee Fairbairn Foundation.
OrthoPediatrics is raising $6.0 million to further develop its product portfolio, which includes a quiet cast saw as well as nails and plates sized for pediatric cases. The company is also collaborating with Cleveland stem cell researchers to develop a cartilage-generating drug.
Vertos Medical closed a $15.5 million series D financing led by new investor ONSET Ventures, who were joined by CHL Medical Partners, Foundation Medical Partners, Aweida Venture Partners and DFJ Mercury. The company will use the funds to further the U.S. commercialization of the company's mild technology, its minimally-invasive treatment for lumbar spinal stenosis.
Regulatory
Advanced BioMedical Technologies Inc. completed the 60 human clinical test cases it needs for a Chinese marketing application for the PA Absorbable Orthopedic Implant Screw. The company says it will submit the study data to China's State Food and Drug Administration once the collection of comparison data is completed.
curasan received CE Mark clearance for its Advanced Tissue Regeneration (ATR) system, which is used to enrich growth factors in the blood for the treatment of a number of conditions, including disorders of bone and mucous tissue. The product is disposable and does not require a centrifuge, and the company says it provides a higher concentration of growth factors than PRP. The company plans to launch ATR in early 2010.
Custom Spine received 510(k) clearance for the Pathway Articulating Vertebral Interbody Device (AVID). The company describes the Pathway AVID as consisting of three intra-linked spacers made from PEEK-OPTIMA. The device is implanted transforaminally, and the spacers are sequentially articulated "to create an interbody that follows the natural curvature of the vertebra."
Stryker resolved one of its four FDA Warning Letters, this one relating to concerns over the company's Biotech division, which manufactures OP-1. The FDA alleged that violations at the site included falsification of documents related to the sale of OP-1 under an HDE. The other outstanding warning letters relate to manufacturing issues in the company's Cork, Ireland and Mahweh, NJ facilities.
Product Introduction and Update
US Spine launched the Javelin MIS Locking Facet System, which is designed to stabilize the lumbar spine by locking the facet joints. According to the company, implantation requires a minimally-invasive incision and offers an alternative to screw and rod systems.
Wright Medical launched the DYNASTY BIOFOAM Acetabular Cup, a titanium component that features a roughened texture for enhanced fixation compared to traditional porous heads. The company adds that the BIOFOAM material has a trabecular structure intended to "mimic bone and contribute to bone in-growth and biological fixation."
Distribution
elliquence, a manufacturer of orthopedic and neurosurgical products, and Bonovo Orthopedics partnered to distribute elliquence products in China. These products include the Surgi-Max and the Trigger-Flex Bipolar System for use in minimally-invasive procedures.
Operations
Wright Medical Group will relocate its distribution and support facilities from Crteil, France to its European headquarters in Amsterdam by Dec. 31. The company says the move will cost up to $5.0 million, including severance and benefits costs to Crteil employees.
Appointments
SpineAlign Medical appointed Gary L. Grenter President and Chief Executive Officer. He was also named to the company's Board of Directors. Prior to joining SpineAlign, Grenter was the Group President for Spacelabs Healthcare and has also held posts as President and CEO for Kyphon and Bioelectron.
