Orthopedic News Roundup 26-Apr-07
BY LAUREN UZDIENSKI, APRIL 26, 2007
Earnings
Large Joints
Zimmer reported income of $233.4 million, or $0.98 per share, beating estimates of $0.93. The quarter compares to a profit of $205.6 million, or $0.82 per share in 1Q:06. Revenue rose 10% to $950.2 million from $860.4 million in the comparable quarter, beating estimates of $934.1 million. Individual highlights included the implantation of 14,427 Zimmer Gender Solutions™ knees, an increase of 51% over the previous quarter, as well was a 22% increase in dental sales, a 32% increase in extremities sales and 11% increases in worldwide and American reconstructive sales.
Spine
Nuvasive reported a net loss of $4.4 million or $(0.03) per share in 1Q:07, beating analysts' estimates of $(0.19). Revenues were reported at $33.2 million, beating estimates of $31.4 million and representing a 69% increase over the comparable quarter. The growth was attributed to sales of MAS products as well as SpheRx II, XLP Lateral Plate and Formagraft.
Globus Medical reported revenues of $26.5 million in 1Q:07, an increase of 46% over $18.2 million in the comparable quarter. To further encourage growth, the company also announced upcoming developments in motion preservation and biomaterials technology as well as recruitment of sales professionals in the midwestern and western U.S.
Biologics
LifeCell reported 1Q:07 income $6.4 million, or $0.19 per share, a 58% increase year-over-year. Revenue also grew 40%, to $43.0 million from $30.7 million in the comparable quarter. Earnings beat analysts' estimates of $0.17 per share and $40.5 million in revenues. The company attributed the growth to AlloDerm Regenerative Tissue Matrix, with sales of $36.8 million, up from $25.3 million in 1Q:06.
Other
Kensey Nash reported revenue of $19.0 million for its quarter ended March 31, 2007, an increase of 21% from the $15.7 million reported in the comparable quarter. Earnings per share of $0.19 increased 12% from the pro-forma earnings per share of $0.17 in the comparable quarter of fiscal 2006. The company missed estimates of $20.34 million in revenues and earnings of $0.21 per share.
ConMed reported 1Q:07 revenues of $171.0 million, an increase of 7.9% over 1Q:06's $158.5 million. Revenues beat estimates of $167.18. Net income for the quarter increased 44% to $8.5 million, or $0.30 per diluted share, beating estimates of $0.26 per share. This compares to 1Q:06 net income of $5.9 million, or $0.21 per share. The company attributed the increase to "solid top-line growth and continued leverage of CONMED's infrastructure."
M&A
Isotis completed a transfer of rights associated with its PolyActive technology to OctoPlus, a drug delivery and development company, in exchange for a payment of approximately $1.7 million and royalty payments on future sales. Under the agreement, IsoTis retains the rights to manufacture, market and sell orthopedic plugs and cement restrictors, including those related to its PolyActive technology-based SynPlug®.
Regulatory
RSB Spine received 510(k) approval to use the InterPlate™ Vertebral Body Replacement System without supplemental fixation. The new indication will allow RSB Spine to market the product as an anterior fusion device, without the need for additional posterior implant support. The company plans submissions for cervical and lumbar interbody indications, as well as new product designs based on the InterPlate platform.
ArthroCare received 510(k) clearance for the Magnum PI Knotless Implant System, which utilizes PEEK implants for the attachment of soft tissue to bone.
Schwartz Biomedical subsidiary BioDuct LLC received FDA approval to market its Meniscal Fixation Device. According to the press release, the technology allows the meniscus to be repaired and not removed.
Product Introduction
Wright Medical announced this week the launch of three hip devices: The DYNASTY™ Acetabular Cup System, which utilizes larger-diameter femoral heads with screw fixation and offers both metal and cross-linked polyethylene bearing surface options; the PROFEMUR® TL Stem, which combines Wright's modular neck technology and a flat tapered wedge geometry stem; and GLADIATOR™ Bipolar System, which features a cross-linked polyethylene bearing surface with a lock detail and is designed to prevent loosening of the insert, disassociation of the head from the shell and osteolysis from polyethylene wear.
Service Agreements
Lifecore Biomedical entered into an exclusive license agreement and development agreement with Cleveland Clinic to develop and commercialize hyaluronan-based products and related applications. Lifecore has licensed a patented hyaluronan-based cross-linking technology that can have applications in orthopedics as well as other medical fields. Preliminary animal studies have been conducted at the Cleveland Clinic, and results were said to be "encouraging."
Investigations
To resolve backdating concerns, Biomet included in a preliminary SEC filing an agreement stating that executives involved with the backdated options will repay to the company the aggregate amount by which the options granted were less than the fair market value of the stock on the date each option was granted. The agreement also stated the exercise price of unexercised options may be increased.
Appointments
Kyphon announced the appointment of D. Keith Grossman to its board of directors. Grossman's previous roles include president and chief executive officer of Thoratec Corporation, a publicly held medical technology company. He will stand for election at the company's 2007 annual shareholder meeting on June 14, 2007.
CoreSpine Technologies appointed Jeffrey Wang, M.D. as a Medical Advisory Board member. Co-founder of CoreSpine Christine Horton praised "Dr. Wang's experience in emerging and existing spinal therapies," and added, "In addition to his surgical experiences as the Chief of Spine Services and Co-Director of the UCLA Spine Center, Dr. Wang's academic career as an Associate Professor of Orthopedics at UCLA brings a strong, new component to our Medical Advisory Board."
Apatech appointed John von Benecke to the position of Group Financial Controller. In his prior position, he was responsible for Business Planning and Analysis at Biocompatibles Plc. Apatech also appointed Ian Ellis Vice President - Marketing.
