Alphatec Holdings, Inc. (Nasdaq:ATEC), the parent company of Alphatec Spine, Inc., a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spine disorders, with a focus on treating conditions related to the aging spine, announces today that, based on preliminary financial data, the Company will report record consolidated quarterly revenues of approximately $38.4 million for the first quarter 2010, an increase of 25.6% from the $30.6 million reported for the first quarter 2009, and a sequential increase of 5.0% over fourth quarter 2009 revenues of $36.6 million. The Company's revenue results remain subject to review by its independent registered public accounting firm in accordance with Statement on Accounting Standards No. 100. The consolidated revenues for the first quarter 2010 do not include the revenues of Scient'x S.A., which was acquired on March 26, 2010.
Aging Spine Product Update
The Company's OsseoFix Spinal Fracture Reduction System, a minimally invasive device that stabilizes the vertebral body, reached a significant milestone in the European market with over 900 patients having been treated as of March 31, 2010. OsseoFix is now being sold in six countries and is being launched through our newly acquired direct sales organizations in France, Italy, and the U.K. during the second quarter of 2010.
"We are particularly pleased with the performance of the OsseoFix product, and we believe the surgical results that are being generated are compelling. For example, we have a documented case of a German surgeon achieving over 15mm of vertebral height correction in a patient; this is a significant enhancement and sets OsseoFix apart as a unique product for vertebral body height restoration in severely compressed fractures," stated Dirk Kuyper, the Company's President and CEO.
In the U.S., OsseoFix is not approved by the FDA for sale, and the product is being evaluated in an Investigational Device Exemption clinical study to support its 510(k) clearance with the FDA.
OsseoScrew, the Company's proprietary expandable pedicle screw designed for bone requiring additional fixation, was launched in Europe last quarter. The initial surgical results are promising and OsseoScrew has been successfully used in revision and highly osteoporotic patients with no complications. The Company anticipates launching OsseoScrew to additional European countries throughout the balance of 2010 both via its direct sales organizations and distribution partners, and the Company plans on collecting long-term clinical data for publication. In the U.S., the Company was recently informed by the FDA that clinical data is required to support the 510(k) clearance process. This clinical study requirement will result in a delay of the U.S. launch of this product, and the Company will provide an update once it has finalized the parameters of the study.
The Company anticipates launching HeliFix in the European market in the second half of 2010 as it continues to build its Aging Spine portfolio of products.
2010 Financial Guidance
Reaffirming full year 2010 financial guidance from December 17, 2009, the Company anticipates combined annualized pro forma revenues of $220.0 million to $225.0 million, $32.0 million to $35.0 million in combined annualized pro forma adjusted EBITDA and combined positive pro forma non-GAAP EPS for the full year 2010, excluding amortization of intangible assets, transaction expenses and acquisition-related restructuring charges. The Company reiterates this guidance to reflect the 2010 pro forma effect of the Scient'x transaction on a full year basis, as if the acquisition closed January 1, 2010. The foregoing guidance does not include U.S. revenues for OsseoFix, and OsseoScrew, neither of which has been approved for sale in the U.S.
As previously announced, the Scient'x transaction closed on March 26, 2010. The Company has absorbed transaction-related costs that had a negative impact to GAAP EPS in the third and fourth quarters of 2009. The Company also expects to absorb additional transaction-related expenses in the first quarter of 2010.
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