Kyphon Signs Definitive Agreements to Acquire All Spine-Related Assets of Disc-O-Tech Medical Technologies
December 20 2006 - 10:59PM
PR Newswire (US)
Agreements Expected to Establish New Product Platform in Minimally
Invasive Fusion and Add Complementary Technology to VCF Treatment
Franchise SUNNYVALE, Calif., Dec. 20 /PRNewswire-FirstCall/ --
Kyphon Inc. (NASDAQ:KYPH), announced today that it has signed two
definitive agreements (the "Transactions") to acquire all of the
spine-related product assets and associated intellectual property
rights of Disc-O-Tech Medical Technologies, Ltd., a privately held
Israeli company, and its U.S. subsidiary (collectively
"Disc-O-Tech"). Kyphon's agreements with Disc-O-Tech are subject to
governmental regulatory review in the U.S. and other customary
closing conditions, and Kyphon presently anticipates being able to
close on both transactions in 2007. Disc-O-Tech's portfolio
includes several innovative products and associated intellectual
property rights for performing minimally invasive spine procedures.
The first transaction concerns the B-Twin Expandable Spinal System,
which is an expandable interbody device for minimally invasive
fusion in patients with degenerative disc disease in the lumbar and
cervical spine and which is CE marked in Europe but not approved
for use in the U.S., and the SKy Bone Expander System, which is
available only outside the U.S. for use in the treatment of
vertebral compression fractures ("VCFs"). The second transaction
concerns Disc-O-Tech's Confidence Cement System and should enable
Kyphon to offer to its customers in the U.S. and abroad another VCF
treatment option depending on a patient's individual needs and a
clinician's goals for his or her patients. The technologies subject
to these Transactions thus promise to further extend Kyphon's
minimally invasive spine franchise beyond its present technologies
for the treatment of VCFs and to diagnose the source of low back
pain. Under the terms of the agreements, Kyphon will pay
Disc-O-Tech $60 million upon execution of the definitive agreements
and another $40 million upon the earlier of either closing of the
agreement concerning acquisition of the B- Twin and SKy Bone assets
or February 1, 2007. A total of another $120 million in three equal
annual installments will be paid beginning in January 2008 for
Disc-O-Tech's Confidence System assets under the second agreement.
An additional $20 million in contingent payments may also be paid
based on the development of further technologies. Kyphon will
finance the upfront payments due under the definitive agreements
with cash on hand and an already established escrow. Kyphon expects
to incur an estimated pre-tax charge of approximately $30 to $40
million for in-process research and development (IPR&D) in 2007
associated with the Transactions. Although the company has not
finalized the purchase price allocations and thus cannot yet assess
the exact impact on 2007 GAAP earnings, Kyphon anticipates that the
Transactions will be significantly dilutive to 2007 GAAP earnings
due to the expected level of transactions- related intangible
amortization and the fact that the IPR&D charge will not be
tax-deductible. Excluding the impact of the non-cash IPR&D
charge, Kyphon expects the Transactions in their entirety to be
approximately $0.12 to $0.17 dilutive to pro forma, non-GAAP
earnings per share in 2007 due primarily to the amortization of
intangibles. Excluding both the non-cash IPR&D charge and the
non-cash amortization of intangibles, the company anticipates the
Transactions to be $0.03 to $0.07 dilutive to pro forma, non-GAAP
earnings per share in 2007. In 2008, Kyphon anticipates the
Transactions will be slightly dilutive to GAAP earnings per share,
and slightly accretive to pro forma, non-GAAP earnings per share.
In 2009 and thereafter, the company expects the Transactions will
be accretive. "Disc-O-Tech's innovative B-Twin Expandable Spinal
System and related intellectual property assets will permit Kyphon
to further serve the fast- growing industry segment focused on
minimally invasive treatment of degenerative disc disease," said
Richard Mott, president and chief executive officer of Kyphon.
"Subject to receipt of appropriate regulatory clearances, the
acquired VCF products also promise to expand our capabilities to
offer clinicians a broad suite of fracture management and repair
options both in our established markets as well as providing
opportunities to access more cost-sensitive emerging markets. With
these asset acquisitions, coupled with the recently announced
definitive agreement to acquire St. Francis Medical Technologies
and the X-STOP(R) Interspinous Process Decompression System, we
have established two new platforms for continued growth in
minimally invasive spinal therapies while bolstering our core VCF
fixation franchise," concluded Mott. "We are pleased to be able to
couple our unique technology platforms with Kyphon's strong sales
channel resources to provide spine specialists with less invasive
treatment options for their patients," said Motti Beyar, president
and chief executive officer of Disc-O-Tech Medical Technologies.
"Kyphon is the ideal partner to maximize the potential of our
innovative portfolio as they share our commitment to bringing
advanced spinal therapy technologies to the clinician and patient
communities." Transactions Expected to Establish New Growth
Platform in Minimally Invasive Fusion The B-Twin Expandable Spinal
System is the first interbody device suitable for percutaneous
stabilization of the lumbar and cervical spine during a fusion
procedure. The B-Twin technology can be used in both stand-alone
and "360" motion segment stabilization procedures; both procedures
may be performed minimally invasively using only posterior access
to the interbody space. Although the B-Twin technology is only
available outside the U.S., Kyphon is evaluating product
development and regulatory path strategies for the U.S. market. The
minimally invasive, low-profile nature of the B-Twin technology
platform is representative of a growing number of technologies that
offer advantages over traditional technologies, such as less blood
loss, reduced tissue and muscle trauma, lowered risk of
neurological damage and infection, and shorter procedure and
recovery time. To date, over 13,000 B-Twin devices have been
implanted and preliminary data published in the clinical literature
demonstrate improvements in back pain and function. Back pain
affects four out of five Americans at some point in their lives,
with more than 150,000 lumbar and nearly 200,000 cervical spinal
fusions performed each year to treat common spinal conditions such
as degenerative disc disease and spondylolisthesis (misaligned
vertebrae). In January 2006, Kyphon announced its acquisition of
InnoSpine, Inc., which led to a limited U.S. launch of the
Discyphor(TM) catheter used during the Functional Anaesthetic
Discography(TM) procedure to diagnose the source of low back pain.
In December 2006, Kyphon announced its execution of a definitive
agreement to acquire St. Francis Medical Technologies, Inc., which
manufactures the X STOP(R) Interspinous Process Decompression
(IPD(R)) System, the first FDA-approved interspinous process device
for treating lumbar spinal stenosis. Kyphon's ability to offer such
additional minimally invasive diagnostic and therapeutic tools to
its customers is a natural next-step in broadening our product
offerings in the treatment of degenerative disc disease.
Transactions Expected to Expand Vertebral Augmentation Product
Suite Disc-O-Tech's product portfolio for the treatment of VCFs
includes the Confidence Cement System which complements Kyphon's
existing KyphX(R) family of products for performing balloon
kyphoplasty. The Confidence System incorporates a delivery
mechanism that is designed to provide controlled injection of
putty-like cement, reduce clinician radiation exposure and
streamline cement preparation. Subject to antitrust clearance in
the U.S., the Confidence System along with the SKy Bone Expander
System promise to extend Kyphon's ability to address a $3 billion
market opportunity comprised of approximately one million diagnosed
fractures that occur each year in the United States, Europe and
Japan by offering customers an increased variety of treatment
options depending on a patient's individual needs and a clinician's
goals in treating his or her patients. Leverages Direct Global
Sales Organization and Established Physician Base Kyphon to date
has trained approximately 10,000 spine specialists worldwide to use
its KyphX(R) product for performing balloon kyphoplasty, including
5,800 spine specialists at 1,755 hospitals in the U.S. These
established relationships are expected to provide significant
opportunities for the expanded distribution of Disc-O-Tech's
portfolio of products as well as further leverage the company's
direct spine sales force, which numbers over 400 worldwide and is
believed to be the largest direct minimally invasive spine sales
force in the industry. Conference Call and Webcast Kyphon
management will host a conference call to discuss its agreement
with Disc-O-Tech Medical Technologies, Ltd. on Thursday, December
21, 2006 at 5:30 a.m. Pacific Time (8:30 a.m. Eastern Time).
Interested parties may access the call by dialing 1-800-811-8824
(U.S.) or 1-913-981-4903 (International). A live webcast of the
call will also be available from the Investor Relations section of
the company's corporate Web site at http://www.kyphon.com/. The
call will be archived on this site for a minimum of two months. An
audio replay of the call will also be available beginning from 9:30
a.m. Pacific Time on Thursday, December 21, 2006, until 12:00 p.m.
Pacific Time on January 11, 2007. To access the replay, dial
1-888-203-1112 (U.S.) or 1-719-457-0820 (International) and enter
access code 2547651. About Kyphon Inc. Kyphon develops and markets
medical devices designed to restore spinal function and diagnose
low back pain using minimally invasive technologies. The company's
products are used in balloon kyphoplasty for the treatment of
spinal fractures caused by osteoporosis or cancer, and in the
Functional Anaesthetic Discography procedure for diagnosing the
source of low back pain. More information about the company and its
products can be found at http://www.kyphon.com/ and its patient
education Web site, http://www.spinalfracture.com/. NOTE: Discyphor
and Functional Anaesthetic Discography are trademarks, and Kyphon
and KyphX are registered trademarks, of Kyphon Inc. Disc-O-Tech,
B-Twin, Confidence and SKy are trademarks of Disc-O-Tech Medical
Technologies, Ltd. X STOP, IPD, and ST. FRANCIS MEDICAL
TECHNOLOGIES are registered trademarks of St. Francis Medical
Technologies, Inc. This press release contains forward-looking
statements within the meaning of the U.S. Private Securities
Litigation Reform Act of 1995. Forward looking statements include,
but are not limited to, those that use words such as "believes,"
"expects," "anticipates," "targets," "intends," "plans,"
"projects," and words of similar effect, and specifically include
the company's future financial projections and anticipated business
direction and performance. Forward-looking statements are based on
management's current preliminary expectations without taking into
account any possible impact from any other future business
development transaction and are subject to risks, uncertainties and
assumptions, which may cause the company's actual results to differ
materially from the statements contained herein. Material factors
that may cause results to differ from the statements made include
delays in obtaining regulatory approvals for either or both
transactions; delays in completing the transactions, and the risk
that either or both of the transactions may be subject to material
conditions in order to obtain regulatory approval, or may not be
completed at all; failure to achieve the revenues, cost savings,
growth prospects and any or other synergies expected from the
proposed transactions; the combined company may require additional
capital and may not be able to raise sufficient capital, on
favorable terms or at all; and delays and challenges associated
with integrating the companies, including employees and operations,
after the transactions are completed. Other information on
potential risk factors that could affect Kyphon, its business and
its financial results are detailed in the company's periodic
filings with the Securities and Exchange Commission (SEC),
including, but not limited to, those risks and uncertainties listed
in the section entitled "Management's Discussion and Analysis of
Financial Condition and Results of Operations - Factors Affecting
Future Operating Results," which can be found in Kyphon's annual
report on Form 10-K for the year ended December 31, 2005 filed with
the SEC on March 3, 2006 and in Kyphon's quarterly report on Form
10-Q for the quarter ended September 30, 2006 filed with the SEC on
November 9, 2006. Kyphon undertakes no obligation to release
publicly any revisions to any forward-looking statements contained
herein to reflect events or circumstances after the date hereof.
KYPHG DATASOURCE: Kyphon Inc. CONTACT: Julie D. Tracy, Vice
President, Investor Relations and Corporate Marketing of Kyphon
Inc., +1-408-548-6687, or Web site: http://www.kyphon.com/
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