Musculoskeletal News Roundup 22-Jan-08
BY LAUREN UZDIENSKI, JANUARY 22, 2009
Earnings
aap Implantate pre-announced 4Q:08 and full-year 2008 revenues of EUR 7.1 million ($10.0 million) and EUR 31.2 million ($44.0 million), respectively. 4Q:08 revenues declined 24% from the year-ago period, which the company attributed to "more orders from global partners" in 4Q:07. Full-year sales were up 11%. Among segments, 2008 trauma and orthopedics sales were up 28% over 2007, and bioimplant sales were up 3% over 2007.
Johnson & Johnson reported 4Q:08 revenues of $15.2 billion, down 1% (constant currency) from 4Q:07 and missing estimates by $0.7 billion. The company reported net income of $2.7 billion, or $0.97 per share. EPS before items was $0.94 cents, up 7% from 4Q:07 and beating estimates by $0.02. DePuy reported 4Q:08 sales of $1.25 billion, up 8% (constant currency) over 4Q:07. Among segments, hip sales grew 11%; knee grew 6%; spine grew 8%; and sports medicine grew 12%.
RTI Biologics, Inc. pre-announced 4Q:08 revenues of $37.3 million, which represents a 46% increase over 4Q:07 and is in line with a prior pre-announcement in December. Revenue growth reflects the acquisition of Tutogen Medical.
M&A
Smith & Nephew has renegotiated the purchase agreement for Plus Orthopedics to reduce the total original purchase price by $141.0 million. In May 2007, Smith & Nephew announced plans to purchase Plus for $889.0 million. Smith & Nephew adds that the agreement also releases Plus vendors from substantially all of their warranties, including those relating to taxation, under the original purchase agreement and has dropped all existing claims under the original warranties.
Private Placements
Last week ReGen Biologics completed the first of a two-stage private placement of approximately $7.0 million of common stock. The second stage expected to be valued at $3.0 million in additional common stock, providing a total of approximately $10.0 million in combined gross proceeds. The funds will support the launch of Menaflex in the U.S. Sanderling Venture Partners led the transaction with a new investment of approximately $4.0 million, and investors in the second stage are holders of options issued from an earlier private placement.
Regulatory
LDR obtained China regulatory approval to market their second-generation Mobi-C cervical artificial disc. The company, which has offices in Beijing and Shanghai, says the approval "strengthens LDR's position in the growing Asian market."
Product Introduction and Update
Smith & Nephew Endoscopy launched the DYONICS 5.5mm BONECUTTER ELECTROBLADE Resector for the treatment of subacromial impingement. The company describes the product as an all-in-one device: a mechanical shaver for soft tissue removal, a burr to smooth bone, and a radiofrequency probe to seal blood vessels at the surgery site.
Clinical
Mesoblast received Australian institutional ethics approval to begin the first human trial of RepliCart, its adult stem cell treatment, for prevention of knee osteoarthritis after ACL repair. The randomized, placebo-controlled, Phase 2 trial will enroll 24 patients between 18 and 40 years old who have undergone ACL repair within six months of a traumatic knee injury. Patients will be randomized to receive either RepliCart with hyaluronan or hyaluronan alone. The trial's primary endpoint will be safety of the stem cell therapy at 12 months, and its secondary endpoint is the prevention of cartilage loss and knee osteoarthritis during this period.
Miscellaneous
RiskMetrics Group, the proxy advisory firm formerly known as ISS, recommended that shareholders of Orthofix International vote in favor of Ramius’ proposal to call a special general meeting, at which Ramius will propose a change in the composition of Orthofix's Board of Directors.
Appointment
Custom Spine announced that Lew Bennett has been appointed President and will join the Board of Directors. Previously, he served as Executive Vice President, Officer and Board Member of NuVasive, Inc.; early investor, Executive Vice President, Officer and Director of Sofamor Danek; President, General Medical Division, Smith & Nephew, Inc. and President of Dillon Manufacturing. In addition, he was one of the founders of Howmedica Corporation and serves on the Board of Directors for HydroCision.
