Musculoskeletal News Roundup 13-Mar-2008
BY LAUREN UZDIENSKI, MARCH 13, 2008
Earnings
BioMimetic Therapeutics reported 4Q:07 revenues of $4.5 million, up from $1.9 million in 4Q:06 but missing analysts' estimates by $1.1 million. Revenues included $3.6 million of product sales of GEM 21S to Luitpold, $0.7 million of royalty income and $0.2 million of sublicense fee income. The company reported a net loss for 4Q:07 of $6.9 million, or $0.37 per share, missing estimates of a net loss of $0.31 per share. In the year-ago period, the company reported a net loss of $5.3 million.
Inion reported preliminary 2007 revenues of EUR 5.2 million ($7.66 million), down 8% from 2006. Excluding one-time expenses, operating loss improved to EUR 12.0 million ($16.67 million) from EUR 14.1 million ($18.62 million) in 2006. The spine segment contributed EUR 0.4 million ($0.59 million) to revenues; specialty orthopedics EUR 1.3 million ($1.91 million); sports medicine EUR 1.1 million ($1.62 million) and dental EUR 0.1 million ($0.15 million). The company also described components of their new commercial strategy, among them: focusing on the spine and specialty orthopedics market segments and divesting non-core assets; targeting U.S. markets and select ROW territories; using a focused network of specialist distributors; and an R&D emphasis on product development in key segments and longer-term focus on next-gen biomaterials.
Orthovita reported 4Q:07 revenues of $15.6 million, a 13% increase over the year-ago period, missing estimates by $0.6 million. Sales growth was attributed to increased sales of VITOSS FOAM and VITAGEL product portfolios in the U.S. Net loss for 4Q:07 increased to $4.9 million, or $0.06 per share, from $4.3 million in the year-ago period. Analysts were estimating a net loss of $0.03 per share.
M&A
Wright Medical Group, Inc. announced plans to acquire INBONE Technologies, Inc. INBONE manufacturers the INBONE Total Ankle System and the INBONE Intra-osseous Fusion Rod and Plate System. Financial terms include an initial cash payment of $24.0 million, guaranteed minimum future payments of $3.7 million and potential additional performance-based cash payments.
NuVasive, Inc. announced the buy-out of royalty obligations on its SpheRx pedicle screw for a single cash payment of $3.25 million. This grants NuVasive complete ownership of all features, designs and patents related to "ball-in-rod" technology for use in current and future products. Additionally, the company has acquired an exclusive license to intellectual property for the development of its next-generation pedicle screw system. Terms of that transaction include a $3.0 million cash payment and certain royalty obligations on sales of the developed product. The company says the new system, to be developed in 2009, will provide greater access to multi-level constructs and trauma procedures.
Regulatory
Life Spine announced that its Lynx cross-connector system has received 510(k) clearance for use in surgical lumbar fusion procedures. Life Spine's President, CEO and founder Michael S. Butler says, "The cross connector provides multiaxial adjustability in all planes and is simple to use, as it snaps onto the rods, self-adjusts and locks with a single instrument. What's more, we have developed both straight and pre-arched versions of the Lynx, providing more tissue sparing surgical options."
Legal
Following John Ashcroft's controversial receipt of a no-bid contract to serve as Zimmer's corporate monitor, the DOJ announced internal guidelines for appointing monitors in out-of-court settlements with large companies.
A U.S. Court of Appeals ruled in favor of TriMed, Inc. in a patent dispute with Stryker. The court found that two Stryker devices have "precisely the same structure" as TriMed's Radial Pin Plate and Ulnar Pin Plate, reversing a lower court's decision.
Product Introduction and Update
Integra LifeSciences launched three new products in its biologics line last week: the Integra OS Osteoconductive Scaffold, a bone void filler manufactured from beta tri-calcium phosphate and type I bovine collagen, Trel-X DBM and Trel-XC, which is DBM mixed with cancellous bone. The new products were launched through the company's Extremity Reconstruction division.
Depuy announced plans to make design changes to its Charite disc. Michael Mahoney, chairman of J&J's DePuy orthopedics group, said said the redesign was motivated by the company's struggle to get full reimbursement for the product amid a lack of clinical data.
Clinical
Genzyme announced new clinical data from a multi-center U.S. study showing that 87% of patients treated with Carticel who experienced improvement in knee function at early follow-up sustained their improvement for up to 10 years. Among 72 patients enrolled at 35 sites, 75% experienced significant improvement in their knee function at short-term follow-up, and 87% had sustained improvement at a later follow-up period of between 6 and 10 years (mean: 9.2 years).
Appointment
Nobel Biocare appointed Dr. Dirk Kirsten Chief Financial Officer and member of the Executive Committee. He will assume his new role in 1H:08. Kirsten joins Nobel Biocare from Syngenta, and he has also held posts at Roche, Deutsche Bank and PricewaterhouseCoopers.
