Earnings
ArthroCare reported 1Q:10 revenues of $90.6 million, up 15% over the year-ago period and beating estimates by $5.0 million. Among the company's orthopedics division, sports medicine sales were $60.4 million and spine sales were $4.4 million. Net income for the quarter was $15.1 million, improved from a loss of $3.5 million for 1Q:09. EPS of $0.24 beat estimates of $0.13.
Smith & Nephew reported 1Q:10 revenues of $995 million, up 9% over the year-ago period. This growth includes sales from three extra trading days, which added an estimated 5% to the growth rate. 1Q:10 revenues beat analyst estimates by $20 million. Orthopedic sales increased 6% to $566 million, with hip up 6%, knee up 9%, trauma up 3% and clinical therapies up by 5%. Endoscopy sales increased 15% to $216 million. All growth rates exclude the effects of currency. Adjusted EPS was $0.19, which compares to $0.13 in 1Q:09 and beat analyst estimates by $0.02.
DJO reported 1Q:10 revenues of $240.1 million, up 8% over 1Q:09. 1Q:10 revenue growth was hindered by the discontinuation of certain unprofitable product lines in 2009 and the sale of a small, non-core spine product lines in 2009. Excluding 2009 revenue from these products, 1Q:10 sales would have demonstrated 10% growth over 1Q:10. Net loss for the quarter was $33.7 million, compared to a loss of $14.3 million in 1Q:09. The loss was attributed to "significant non-recurring charges and other adjustments related to ongoing restructuring activities and acquisitions."
Symmetry Medical reported 1Q:10 revenue of $84.5 million, reflecting a 17% decrease from the year-ago period and beating estimates of $75.8 million. The company reported that it is seeing "increased customer demand across all product lines." Instrument sales declined by 28% and implants were down by 3%. Adjusted net income for the quarter was $2.0 million, or $0.06 per diluted share, down from an adjusted net income of $6.9 million, or $0.19 per diluted share, in the year-ago period and beating estimates by a penny.
TranS1 reported 1Q:10 revenues of $6.7 million, down 23% from the year-ago period. The company sees signs of stabilization in its AxiaLIF product line as it "continue[s] to work with [its] current and prospective surgeon users, the payor community and the spine societies to navigate the current reimbursement landscape." The company reported a loss of $0.31 per share, widening from a loss of $0.25 per share in 1Q:09. Analysts had forecast a loss per share of $0.25.
Wright Medical announced 1Q:10 revenues of $131.2 million, representing a 7% increase over 1Q:09 and beating estimates by $2.6 million. Among segments, hip increased by 8%; knee increased by 5%; extremity increased by 15% and biologics decreased by 1%. All growth rates exclude the effects of currency. Adjusted net income in 1Q:10 was $8.5 million, up from $7.8 million in 1Q:09. Adjusted EPS of $0.16 beat estimates by $0.01.
Integra reported 1Q:10 sales of $172.7 million, up 6% over the year-ago period and beating estimates of $171.1 million. Orthopedic sales increased 9% to $70.2 million. Adjusted net income for 1Q:10 was $19.0 million, or $0.63 per diluted share, up from $17.0 million, or $0.58 per diluted share, in 1Q:09. Analysts had forecast EPS of $0.57.
MAKO Surgical reported 1Q:10 revenue of $7.2 million, up 94% over the year-ago period and missing estimates by $0.9 million. The company noted that during the quarter, four new RIO systems were installed, bringing the total to 40 systems in use. Additionally, 731 MAKOplasty procedures were performed during the quarter, a 30% sequential increase from 4Q:09. Net loss for 1Q:10 was $11.4 million, or $0.34 per share. Analysts had forecast a loss per share of $0.26.
M&A
Landec Corporation acquired LifeCore Biomedical, Inc. from Warburg Pincus at a valuation of up to $54 million ($40 million in cash, $4 million in assumed debt and up to $10 million in earn-outs.). Back in 2008 Warburg Pincus acquired LifeCore's dental and hyaluronan division for $239 million at an implied enterprise valuation of $200 million. The dental division was mergered into Warburg Pincus's dental portfolio company, Keystone Dental, and the hyaluronan division was sold to Landec.
Funding
Curexo Technology Corporation announced it has closed on $13.2 million of funding. The company's "CAD/CAM" surgical robotic system is geared for Total Joint Replacements. Funds will be used for product development, initial clinical show sites in the US and driving awareness of the company's technology.
Regulatory
Bone Solutions Inc. announced the company's plans to file four additional 510(k) applications for its OsteoCrete platform. OsteoCrete has already received FDA clearance as a proprietary bone void filler.
DGIMED ORTHO announced clearance of its 510(k) submission for the DISTALOCK Titanium Femoral Intramedullary Nail system. According to the company the system is "designed to improve clinical outcomes by facilitating fast and accurate placement of the distal locking screws, while reducing or eliminating the use of x-ray required with standard techniques."
Product Introduction & Update
Ascension Orthopedics launched the NuGrip CMC Implant which is a joint replacement for the base of the thumb. The implant is made of PyroCarbon, a material which offers superior wear and biocompatibility characteristics. According to the company, the NuGrip CMC Implant is a "bone-preserving, reliable alternative to soft tissue reconstruction which is the standard treatment for this indication."
Aesculap introduced Aesculap Implant Systems’ S4 FRI, or Fracture Reduction Instrumentation which "allows the spine surgeon to perform realignment, distraction and compression of the fracture site through the S4 pedicle screw and rod system."
Legal
A federal judge in Michigan threw out a whistleblower lawsuit against Stryker that accused the company of a kickback scheme. However, the judge gave the plaintiffs a 21 day window to amend their complaint.
Wright Medical announced that the company expects to settle an ongoing DOJ investigation with an $8 million payment. The company is in talks with the DOJ and OIG to resolve the matter.
Clinical
Smith&Nephew highlighted Canadian data on their BIRMINGHAM HIP Resurfacing (BHR) System previously presented at this year's AAOS meeting. Nine sites demonstrated 99.91% of their 3,400 hip resurfacing patients experienced no implant failure due to metal wear debris at three years post-op. According to the company, this data and other publications listed address the metal wear debris concerns raised about metal-on-metal hip implants.
Mazor released data highlighting the results of a comprehensive study evaluating the outcome of pediatric scolosis and deformity surgeries utilizing the company's SpineAssist miniature robotic spinal surgery system. 99.9% of the implants positioned with the help of the SpineAssist in 80 children were "in line with the clinical requirements." No further corrective surgery was needed after the first procedure which is "an extraordinary result in this field."
Mesoblast announced the completion of enrollment in the company's first stem cell trial for posterolateral lumbar spinal fusion. The study has been taking place at New York's Hospital for Special Surgery and compares the safety and efficacy of Mesoblast's NeoFuse allogeneic stem cell product on one side with autograft bone on the other side in the same patient. The results demonstrated the safety of the implanted cells and the association of the cells with earlier new bone formation and robust fusion.
Collaborations
Stryker and Intuitive Surgical announced a collaboration to create advanced minimally invasive (MIS) robotic surgery suites. According to the companies, this will provide surgeons and operating room staff more flexibility and additional information.
Appointments
Alphatec announced that Michael J. Sarrasin, who has over 20 years of clinical, quality assurance and regulatory affairs experience in the medical device and life sciences industries, has been named the Company's Vice President, Clinical, Quality and Regulatory. The company also announced that Armin Weichert, who has over 25 years of sales and management experience in the medical device and life sciences industries, has been named the Company's new Vice President and General Manager, Latin America.
