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.
About Alphatec Spine
Alphatec Spine, Inc. is a wholly owned subsidiary of Alphatec
Holdings, Inc. (Nasdaq:ATEC). Alphatec Spine is a medical device
company that designs, develops, manufactures and markets products
for the surgical treatment of spine disorders, primarily focused on
the aging spine. The Company's mission is to combine
world-class customer service with innovative, surgeon-driven design
that will help improve the aging patient's quality of
life. The Company is poised to achieve its goal through new
solutions for patients with osteoporosis, stenosis and other aging
spine deformities, improved minimally invasive products and
techniques and integrated biologics solutions. In addition to
its U.S. operations, the Company also markets its products in over
50 international markets through its subsidiary, Scient'x S.A., via
a direct sales force in France, Italy and the United Kingdom and
via independent distributors in the rest of Europe, the Middle East
and Africa, South America and Latin America. In Asia and
Australia, the Company markets its products through its subsidiary,
Alphatec Pacific, Inc, and through Scient'x's distributors in
China, Korea and Australia.
Also visit the Aging Spine Center, www.agingspine.com, a
web-based information portal for healthcare providers and patients
regarding aging spine disorders and their treatment. Alphatec
Spine is working with the National Osteoporosis Foundation as well
as other clinical portals that provide peer-reviewed content, to
populate the Aging Spine Center. The interactive website will
enable patients to review pertinent information about all the key
disorders that affect the aging spine in an easy-to-understand
format that includes videos, graphics and questions that should be
asked of caregivers. Medical information will include published
abstracts regarding the aging spine.
The Alphatec Holdings, Inc. logo is available at
http://www.globenewswire.com/newsroom/prs/?pkgid=3520
Projected Non-GAAP Information
Projected non-GAAP earnings included in this press release is a
non-GAAP (generally accepted accounting principles) financial
measure that represents net income (loss) excluding the effects of
in-process research and development expenses, transaction related
expenses and acquisition-related restructuring expenses and
litigation settlement expenses. Management does not consider these
expenses when it makes certain evaluations of the operations of the
Company. Projected non-GAAP earnings, as defined above, may not be
similar to non-GAAP earnings measures used by other companies and
is not a measurement under GAAP.
Projected adjusted EBITDA included in this press release is a
non-GAAP financial measure that represents net income (loss)
excluding the effects of interest, taxes, depreciation,
amortization, stock-based compensation costs, and other
non-recurring income or expense items, such as in-process research
and development expense, acquisition-related restructuring expenses
and transaction related expenses. Projected adjusted EBITDA, as
defined above, may not be similar to adjusted EBITDA measures used
by other companies and is not a measurement under GAAP.
Though management finds GAAP-based earnings or loss and adjusted
EBITDA useful for evaluating aspects of the Company's business, its
reliance on these measures are limited because excluded items often
have a material effect on the Company's earnings and earnings per
common share calculated in accordance with GAAP. Therefore,
management uses non-GAAP earnings and adjusted EBITDA in
conjunction with GAAP earnings and earnings per common share
measures. The Company believes that non-GAAP earnings and adjusted
EBITDA provides investors with an additional tool for evaluating
the Company's core performance, which management uses in its own
evaluation of continuing operating performance, and a base-line for
assessing the future earnings potential of the Company. While the
GAAP results are more complete, the Company prefers to allow
investors to have these supplemental metrics since, with
reconciliation to GAAP, they may provide greater insight into the
Company's financial results.
Forward Looking Statements
This press release contains "forward-looking statements" within
the meaning of the Private Securities Litigation Reform Act of 1995
that involve risks and uncertainty. Such statements are based on
management's current expectations and are subject to a number of
risks and uncertainties that could cause actual results to differ
materially from those described in the forward-looking statements.
These forward-looking statements include, but are not limited to:
the Company's preliminary consolidated revenues for the first
quarter 2010; the Company's 2010 financial guidance, the timing and
results of the clinical trial of OsseoFix and OsseoScrew to support
its 510(k) clearance; the timing and success of launching OsseoFix
and OsseoScrew in additional European countries; that the surgical
results observed for OsseoFix and the Company's other products in
some patients will be typical across the patient population; and
the success and timing of launching HeliFix in the European market.
The Company cautions investors that there can be no assurance that
actual results or business conditions will not differ materially
from those projected or suggested in such forward-looking
statements as a result of various factors, including, but not
limited to, the following: the Company's ability to meet its pro
forma 2010 revenue, adjusted EBITDA, and earnings projections, the
ability to successfully integrate Scient'x and Alphatec, the growth
rate of the spine market related to aging and elderly patients,
uncertainty of success in developing new products or products
currently in the Company's pipeline, the successful global launch
of the Company's new products and the products in its development
pipeline, failure to achieve acceptance of the Company's products
by the surgeon community, failure to obtain FDA clearance or
approval for new products, or unexpected or prolonged delays in the
process, the Company's ability to develop and expand its business
in the United States, Asia and Europe, continuation of favorable
third party payor reimbursement for procedures performed using the
Company's products, unanticipated expenses or liabilities or other
adverse events affecting cash flow or the Company's ability to
successfully control its costs or achieve profitability,
uncertainty of additional funding, the Company's ability to compete
with other competing products and with emerging new technologies,
product liability exposure, patent infringement claims and claims
related to the Company's intellectual property. Please refer to the
risks detailed from time to time in the Company's SEC reports,
including quarterly reports on Form 10-Q, reports on Form 8-K and
annual reports on Form 10-K. The Company disclaims any intention or
obligation to update or revise any forward-looking statements,
whether as a result of new information, future events, or
otherwise, unless required by law.
CONTACT: Alphatec Spine, Inc.
Peter C. Wulff, Chief Financial Officer
(760) 494-6746
investorrelations@alphatecspine.com
Westwicke Partners
Lynn C. Pieper
(415) 202-5678
lynn.pieper@westwicke.com
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