Kyphon Inc. (NASDAQ:KYPH), Sunnyvale, Calif., 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 were
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.
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 www.kyphon.com and its patient
education Web site, www.spinalfracture.com.
For more information, visit http://www.kyphon.com or call
408/548-6687.
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