Orthopedic News Roundup 17-Aug-06
BY HUYEN NGUYEN, AUGUST 17, 2006
Earnings:
Biologics: Tutogen reported 3Q:06 sales of $10 million and a net loss of $1.1 million, or $0.07 per fully diluted share compared to the same quarter last year. The Company would have experienced breakeven results without ~$1.1 million in unusual charges for the quarter (including $210,000 related to strategic discussions with Zimmer Holdings) and foreign currency exchange losses. In addition, the company recognized stock-based compensation expense of $303,000 for the nine-month period that ended June 30, 2006. During the quarter, Spine and Surgical Specialties revenues were down in the US by 51% and 12% respectively, while Dental achieved a 19% increase in US sales. Tutogen is currently making plans to introduce its xenograft product line to the U.S. market for 3Q:07.
Trauma: Synthes reported consolidated 1H:06 financials with sales of $1.2 billion, representing an increase of 14% (15% constant currency). Consolidated sales for 1H:06 in Europe, Asia Pacific, North America and elsewhere increased by 16.8%, 16.6%, 14.7% and 10.5%, respectively. For 2Q:06, sales were reported at $591.2 million, an increase of 13% over 2Q:05. Net earnings for 1H:06 were $243.3 million, an increase of 8% from $224.5 million. Synthes' worldwide trauma sales have grown more significantly than the overall trauma market. In regards to the recent FDA approval of the ProDisc®-L, the Company plans to roll out this product slowly with considerable sales force, surgeon and customer training. Management also confirmed that the AO Foundation acquisition is still expected to close by Q3:06.
Appointment:
Tulip BioMed™, Inc. appointed Kenneth Yonika as its Chief Financial Officer. Mr. Yonika is a certified public accountant (CPA) and has been in the finance industry for more than 18 years. Osiris Therapeutics, Inc. has elected Jay M. Moyes and Gregory H. Barnhill to the Board of Directors. Mr. Moyes served as the Chief Financial Officer of Myriad Genetics, Inc. since June 1996 and previously served as their Vice President of Finance from July 1993 until July 2005. Mr. Barnhill has served as a Partner and Member of the Board of Directors of Brown Advisory Securities, LLC since 2003. The Company also has hired Earl R. Fender as Vice President and General Manager for Orthopedics and Lode Debrabandere, Ph.D. to Vice President and General Manager for Inflammatory Diseases. Previously, Mr. Fender served as Vice President, Sales, U.S. President, and finally as Worldwide President of DePuy Spine. Dr. Debrabandere was with Bristol-Myers Squibb serving as Vice President of Strategic Marketing for Neuroscience and Infectious Diseases.
Business Update:
Late last week, Tutogen Medical Inc. rejected a bid from Zimmer Holdings, Inc. for $5-$6 per share. (Current 52 week range for the stock is between $2.50 - $6.29). Zimmer currently owns 33.2% of Tutogen's common stock, and back in March, Zimmer began exploring a buyout. Last Wednesday Zimmer telephoned Tutogen with the acquisition price which would have valued Tutogen at $80.4 to $96.5 million.
Clinical Update:
Smith & Nephew released the results of a study that showed its Intradiscal ELECTROTHERMAL™ Therapy (IDET™) procedure would spare up to 65% of patients with chronic lower back pain from spinal fusion surgery. The study also found that IDET patients experienced similar outcome benefits when compared against spinal fusion. This study was published in the July issue of the Pain Physician, the official journal of American Society of Interventional Pain Physicians (ASIPP). The Company stated that estimated direct cost for the IDET procedure is $7,000 compared to $50,000 + for a spinal fusion procedure.
Product Introduction:
MIV Therapeutics announced it planning on entering the orthopedic market with the introduction of a new generation of proprietary Hydroxyapatite-based drug delivery nano- and micro-technology coating applications for orthopedic implants. This technology will be unveiled at the upcoming World Orthopedic Organization (SICOT) conference in Buenos Aires later this month.
Regulatory Update:
Earlier this week, Synthes' PRODISC®-L Total Disc Replacement received FDA approval for commercial distribution in the United States. PRODISC®-L is intended to treat lower back pain in patients with degenerative disc disease at a single level from L3 - S1. KFx Medical Corporation has received a 510(k) FDA clearance to market its SutureCross™ Knotless Anatomic Fixation System, intended to repair torn rotator cuff of the shoulder. Genzyme Corp. announced that it has filed with the European authority to expand the CE mark for Synvisc® (hylan G-F 20) to include treatment of pain due to osteoarthritis (OA) of the ankle and shoulder. Current approval is indicated for use in the knee and hip joints. Arthrosurface, Inc. announced that it has recently received FDA clearance for its HemiCAP® system for the treatment of patello-femoral disease. This device is a cartilage surface implant system that is currently marketed in the U.S., Europe, Australasia, Latin America and South Africa for various knee, shoulder, hip and great toe applications.
Miscellaneous:
According to a few sources (news wires and company filings), several major orthopedic manufacturers have been named as defendants in several class actions lawsuits regarding antitrust issues. In addition, Depuy Spine, who owns the Charite disc, is being sued in multiple lawsuits from patients who have complications from the Charite and who are seeking reparations from DePuy Spine.
