Revenues Grow 40% to $128.1 Million; St. Francis Integration Ahead
of Schedule SUNNYVALE, Calif., April 26 /PRNewswire-FirstCall/ --
Kyphon Inc. (NASDAQ:KYPH) today announced operating results for the
first quarter ended March 31, 2007 as follows: Operating Results
Kyphon's worldwide net sales totaled $128.1 million, which includes
$18.1 million of X-STOP(R) Interspinous Process Decompression
(IPD(R)) product sales from the St. Francis Medical Technologies,
Inc. (SFMT) acquisition that closed on January 18, 2007. Total
product sales increased 40%, or 38% at constant foreign currency
exchange rates, compared to the $91.4 million in net sales reported
for the first quarter of 2006. Total revenues in the U.S. increased
34% to $101.1 million, while total international revenues increased
70% to $27.0 million. Revenues from Kyphon's spinal motion
preservation and disc disease diagnosis and therapies businesses,
which includes the X-STOP(R) IPD(R), Aperius(TM) Percutaneous
Lumbar Interspinous Decompression (PercLID(TM)) and Functional
Anaesthetic Discography(TM) (F.A.D.(TM)) technologies, were $14.3
million in the U.S. and $4.2 million in international markets.
Kyphon's core spinal fracture management and repair business
revenue grew 20% to $109.6 million over the same quarter of 2006.
Revenues in the U.S. grew 15% to $86.8 million and revenues from
international operations grew 43% to $22.8 million in the first
quarter. Reported net loss was $22.6 million, or $0.50 per share
compared to net income of $8.5 million, or $0.19 per diluted share,
for the same period a year ago. The reported $0.50 loss per share
includes $40.5 million pre-tax and $31.9 million after-tax SFMT
in-process research and development (IPR&D) charges and
acquisition-related expenses, which are detailed in the
reconciliation of non-GAAP income below. Non-GAAP diluted earnings
per share for the first quarter of 2007 were $0.20, compared to
diluted earnings per share of $0.19 in the same quarter a year ago.
The non-GAAP diluted earnings per share of $0.20 excludes the
following impacts from the SFMT acquisition: (1) $0.45 per share
for IPR&D charges; (2) $0.09 per share for write-off of bank
loan fees associated with the acquisition; (3) $0.05 per share for
purchase accounting adjustments related to inventory valuation; (4)
$0.03 per share for costs related to the transition of SFMT sales
agent activities to Kyphon's direct sales force in the U.S.; and
(5) $0.05 per share for severance and other transitional
compensation expense. A reconciliation of GAAP and non-GAAP
operating results is presented below. "We are pleased with our
strong execution this quarter and the focus that was maintained on
our core spinal fracture management and repair business while
integrating the X-STOP(R) IPD(R) system obtained through our St.
Francis acquisition," said Richard Mott, president and chief
executive officer of Kyphon. "We made excellent progress in
assimilating St. Francis' operations into Kyphon's and undertaking
clinical initiatives designed to support long term procedural
adoption and adequate facility and physician reimbursement for the
X-STOP(R) IPD(R) technology. Furthermore, as device competition
increases in the vertebral compression fracture market, we believe
the ability of balloon kyphoplasty to achieve deformity correction
coupled with the growing body of clinical data for the procedure
remain key considerations for many clinicians in selecting the
appropriate treatment for their spinal fracture patients. We
believe we are well positioned for future growth through our focus
on restoring spinal function through minimally invasive therapies,"
Mott concluded. Business Highlights During the first quarter of
2007: -- Kyphon completed enrollment for its Japan registry trial
for its balloon kyphoplasty inflatable bone tamps and bone cement.
This represents a critical milestone for obtaining regulatory
approval in this key market with an estimated half-million
fractures each year due to osteoporosis. -- The health insurance
company Aetna, Inc. published national coverage for kyphoplasty.
Aetna's membership represents over 30 million covered lives, more
than 767,000 health care professionals, and more than 453,000
primary care physicians at over 4,400 hospitals. -- Kyphon
successfully closed a $400 million offering of convertible senior
notes. The proceeds, together with revolver borrowings, were used
to retire the $425 million senior secured term loan incurred to
complete the acquisition of SFMT. -- Kyphon launched its
Aperius(TM) PercLID(TM) system for the treatment of mild to
moderate lumber spinal stenosis (LSS) in select European markets.
The device received the CE Mark in October 2006 and is a
percutaneous solution used by spine specialists in treating LSS. --
Kyphon early concluded enrollment of patients in its European BEST
(Biomaterials Effectiveness and Safety in Trauma) clinical trial
for the use of its KyphOs(TM) FS calcium phosphate material in
treating vertebral compression fractures caused by trauma. The
clinical trial investigators determined that the interim analysis
after enrolling 51 patients showed highly statistically and
clinically significant improvement in pain in addition to having a
high safety profile. The company is preparing to initiate market
launch activities of KyphOs(TM) FS in select European countries in
the second half of 2007. -- Kyphon initiated enrollment in a pilot
multi-center, prospective, single-arm clinical study evaluating its
Discyphor(TM) Catheter for the F.A.D.(TM) procedure versus
provocative discography. The SODA (Study Of Disc Anaesthesia) study
is expected to enroll up to 100 patients in up to 15 sites and is
designed to measure the proportion of positive disc levels
registered after provocative discography differing from that after
the F.A.D.(TM) procedure. -- Kyphon enrolled 23 patients in its
CAFE (CAncer Fracture Evaluation), study bringing the total
cumulative enrollment to 75 patients. This multi- center,
randomized, controlled study designed to evaluate balloon
kyphoplasty versus non-surgical management in patients suffering
vertebral compression fractures due to cancer is intended to enroll
up to 200 patients. -- Kyphon enrolled 30 patients in its KAVIAR
(Kyphoplasty And Vertebroplasty In the Augmentation and Restoration
of Vertebral Body Compression Fractures) study, bringing the total
cumulative enrollment to 45 patients. This multi-center,
randomized, controlled study is designed to evaluate balloon
kyphoplasty against vertebroplasty on a number of endpoints and is
intended to enroll up to 1,234 patients. Financial Outlook for
Full-Year 2007 and Quarter Ending June 30, 2007 For the full-year
2007, net sales are targeted to increase approximately 40% to 43%
versus 2006 to $570-$585 million. Based on our view of how our
existing business is expected to perform, we are providing this
updated target revenue range although it excludes all of the $5-10
million in 2007 revenue from the Disc-O-Tech products that was
originally included in our previous guidance of $565-$585 million.
The company presently assumes that both previously announced asset
transactions with Disc-O-Tech Medical Technologies, Ltd. will close
by the end of the fourth quarter of 2007; however, both remain
subject to clearance by the Federal Trade Commission and the timing
of the closing of these transactions remains uncertain. We
anticipate approximately 82% to 85% of 2007 revenues will be
generated from our spinal fracture management and repair business
and approximately 15% to 18% will be generated from our spinal
motion preservation business, which includes the X-STOP(R) IPD(R)
and the Aperius(TM) PercLID(TM) system. International revenues are
expected to comprise approximately 22% to 24% of total 2007
revenues. The full-year 2007 target range for earnings per diluted
share, which includes the impact of all of the charges associated
with the SFMT and Disc-O- Tech transactions except the write-off of
IPR&D, is expected to be between $0.80 and $0.88. The target
range for non-GAAP earnings per diluted share excluding IPR&D
charges and the acquisition-related expenses as outlined in the
GAAP to non-GAAP reconciliation provided below is $1.06 to $1.14.
This target earnings range assumes amortization of intangible
charges for the full year of $19 million related to the SFMT
acquisition and $3 million relating to the Disc-O-Tech asset
acquisition transactions. The company estimates that the one-time
pre-tax charge for IPR&D associated with the acquisitions of
SFMT and the spinal assets of Disc-O-Tech will be approximately $56
million. Of the estimated $56 million charge, the $21 million
associated with the SFMT acquisition recorded in the first quarter
of 2007 is non-tax deductible. Kyphon currently assumes the
remaining $35 million of the IPR&D charge relating to the two
Disc-O-Tech transactions will occur in the fourth quarter of 2007.
For the second quarter of 2007, the company anticipates worldwide
net sales of $137 million to $142 million, which represents an
increase of 36% to 41% versus the second quarter of 2006. Worldwide
net sales from the spinal fracture management and repair business
are targeted to be between $114 million to $118 million, which
represents an increase of 13% to 17% versus the same period a year
ago. Net sales from the company's international operations are
targeted to constitute approximately 22% to 23% of worldwide
revenues in the second quarter of 2007. For the second quarter of
2007, the target range for earnings per diluted share including the
impact of certain acquisition related charges is $0.18 to $0.20.
The non-GAAP earnings per diluted share, excluding the after-tax
impact of certain acquisition-related expenses, estimated at $2.7
million pre- tax, is targeted to be between $0.21 and $0.23. A
reconciliation of GAAP to non-GAAP earnings per diluted share for
the company's financial outlook is as follows: Three Months Ending
Year Ending June 30, 2007 December 31, 2007 Projected GAAP earnings
per diluted share $0.18 - $0.20 ($0.05) - $0.03 Add: Write-off of
in-process research and development -- 0.85 Projected earnings per
diluted share, excluding in-process research and development $0.18
- $0.20 $0.80 - $0.88 Add: Acquisition related expenses, net of tax
0.03 0.26 Projected non-GAAP earnings per diluted share $0.21 -
$0.23 $1.06 - $1.14 Selected Metrics Kyphon ended the first quarter
of 2007 with approximately 500 individuals in its worldwide
field-based sales organization, which includes device sales
representatives, sales management, and other field-based sales
professionals. The company is planning to end 2007 with
approximately 580 to 610 field based sales professionals worldwide.
This global sales organization works with spine specialists
worldwide who perform, or who are candidates to perform, the
balloon kyphoplasty procedure and the primary care physician
community, to educate them about the balloon kyphoplasty treatment
for spinal fractures and the X-STOP(R) IPD(R) procedure to treat
lumbar spinal stenosis. Through the first quarter of 2007,
approximately 6,300 spine specialists in the U.S. and 4,800 outside
the U.S. have been trained to perform balloon kyphoplasty. For
2007, Kyphon expects to train a total of approximately 1,700
physicians to perform balloon kyphoplasty procedures, 700 in the
U.S. and 1,000 outside of the U.S. Approximately 1,800 spine
surgeons in the U.S. have been trained to perform the X-STOP(R)
IPD(R) procedure through the first quarter of 2007. In 2007, the
company expects to train approximately 1,800 spine specialists in
the U.S. to perform the X-STOP(R) IPD(R) procedure. Use of Non-GAAP
Financial Measures Kyphon management believes that investors may
wish to consider the impact of certain charges to better understand
short- and long-term financial trends in the company's operations
and financial performance. These charges result from facts and
circumstances that vary in frequency and/or impact on continuing
operations. In addition, Kyphon management uses results of
operations before certain charges to evaluate the operational
performance of the company and as a basis for strategic planning.
Investors should consider these non-GAAP measures in addition to,
and not as a substitute for, financial performance measures in
accordance with GAAP. Reconciliation of GAAP and Non-GAAP Operating
Results Non-GAAP first quarter 2007 results exclude certain
expenses related to the acquisition of SFMT. This non-GAAP
presentation is given in part to enhance the understanding of the
company's historical financial performance and comparability
between periods. In addition, the company believes that the
non-GAAP presentation to exclude certain charges is relevant and
useful information that will be widely used by analysts, investors,
and other interested parties in the medical device industry.
Accordingly, the company is disclosing this information to permit
additional analysis of the company's performance. A reconciliation
of Kyphon's non-GAAP operating results to its GAAP operating
results for this period follows (unaudited, in thousands, except
per share amounts): Three Months Three Months Ended Ended March 31,
March 31, 2007 2006 ----------------------------------- ---------
GAAP Adjustments Non-GAAP GAAP ----------------------- ---------
--------- U. S. net sales $101,107 $-- $101,107 $75,512
International net sales 27,030 -- 27,030 15,916
----------------------- --------- --------- Net sales 128,137 --
128,137 91,428 Operating costs and expenses: Cost of goods sold
19,503 (4,258)(3) 15,245 10,965 Research and development 11,780
(615)(5) 11,165 8,306 Sales and marketing 63,716 (3,839)(4)(5)
59,877 45,386 General and administrative 19,931 (2,398)(5) 17,533
13,568 Amortization of acquired intangible assets 4,415 -- 4,415
283 In-process research and development 21,300 (21,300)(1) -- --
-------------------- --------- --------- Total operating costs and
expenses 140,645 (32,410) 108,235 78,508 --------------------
--------- --------- Income (loss) from operations (12,508) 32,410
19,902 12,920 Interest expense (12,403) 8,061 (2) (4,342) (3)
Interest income (expense) and other, net 1,035 -- 1,035 2,126
-------------------- --------- --------- Income (loss) before
income taxes (23,876) 40,471 16,595 15,043 Provision for (benefit
from) income taxes (1,280) 8,566 7,286 6,550 --------------------
--------- --------- Net income (loss) $(22,596) $31,905 $9,309
$8,493 ==================== ========= ========= Net income (loss)
per share: Basic $(0.50) $0.71 $0.21 $0.19 ====================
========= ========= Diluted $(0.50) $0.67 $0.20 $0.19
==================== ========= ========= Weighted-average shares
outstanding: Basic 45,251 45,251 44,032 =========== =========
========= Diluted 45,251 47,351 45,882 =========== =========
========= (1) In-process research and development (IPR&D)
charges. (2) The write-off of loan fees related to the temporary
bank financing used to close the transaction. (3) Purchase
accounting adjustments related to inventory valuation. (4) Costs
related to the transition of SFMT agents to Kyphon's direct sales
force in the U.S. (5) Severance and other transitional compensation
expense related to the SFMT acquisition. Kyphon's operating results
on both a GAAP and non-GAAP basis includes stock-based compensation
expenses of $6.5 million and $6.4 million for the three-month
periods ended March 31, 2007 and 2006, respectively. Earnings Call
Information Kyphon will host a conference call today at 2:00 p.m.
Pacific Time to discuss its first quarter results. To participate
in the conference call, dial 1-800-289-0572 (U.S.) or 913-981-5543
(International). A simultaneous webcast of the call will also be
available from the Investor Relations section of the company's
corporate Web site at http://ir.kyphon.com/. The call will be
archived on this site for a minimum of two months. An audio replay
of the call will be available beginning from 6:00 p.m. Pacific Time
on Thursday, April 26, 2007, until 12:00 a.m. Pacific Time on
Thursday, May 17, 2007. To access the replay, dial 888-203-1112
(U.S.) or 719-457-0820 (International) and enter the access code
2042530. About Kyphon Inc. Kyphon develops and markets medical
devices designed to restore and preserve spinal function and
diagnose the source of 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, in the Functional Anaesthetic
Discography(TM) procedure for diagnosing the source of low back
pain, and in the Interspinous Process Decompression procedure for
treating lumbar spinal stenosis. More information about the company
and its products can be found at http://www.kyphon.com/. Functional
Anaesthetic Discography, F.A.D., Discyphor, Aperius and PercLID are
trademarks, and Kyphon, KyphX, X-STOP, X STOP, and IPD are
registered trademarks, of Kyphon Inc. Disc-O-Tech, B-Twin and SKy
are trademarks of Disc-O-Tech Medical Technologies, Ltd. 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," "anticipates," "targets," "intends,"
"plans," "may," and words of similar effect, and specifically
include the company's 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. 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, 2006 filed with
the SEC on February 28, 2007. 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. KYPHE Kyphon Inc. Condensed Consolidated Income Statements
(unaudited; in thousands, except per share amounts) Three Months
Ended March 31, ---------------------------------- 2007 2006
--------------- --------------- U. S. net sales $101,107 $75,512
International net sales 27,030 15,916 ---------------
--------------- Net sales 128,137 91,428 Operating costs and
expenses: Cost of goods sold 19,503 10,965 Research and development
11,780 8,306 Sales and marketing 63,716 45,386 General and
administrative 19,931 13,568 Amortization of acquired intangible
assets 4,415 283 In-process research and development 21,300 --
--------------- --------------- Total operating costs and expenses
140,645 78,508 --------------- --------------- Income (loss) from
operations (12,508) 12,920 Interest expense (12,403) (3) Interest
income and other, net 1,035 2,126 --------------- ---------------
Income (loss) before income taxes (23,876) 15,043 Provision for
(benefit from) income taxes (1,280) 6,550 ---------------
--------------- Net income (loss) $(22,596) $8,493 ===============
=============== Net income per share: Basic $(0.50) $0.19
=============== =============== Diluted $(0.50) $0.19
=============== =============== Weighted-average shares
outstanding: Basic 45,251 44,032 =============== ===============
Diluted 45,251 45,882 =============== =============== Kyphon Inc.
Condensed Consolidated Balance Sheets (unaudited, in thousands)
March 31, December 31, 2007 2006 --------------- ---------------
Assets Current assets: Cash and cash equivalents $79,699 $81,939
Investments -- 120,214 Accounts receivable, net 89,437 73,859
Inventories 19,710 11,869 Prepaid expenses and other current assets
11,824 7,520 Deferred tax assets 15,532 6,072 ---------------
--------------- Total current assets 216,202 301,473 Property and
equipment, net 32,233 27,590 Goodwill 357,096 4,802 Other
intangible assets, net 210,446 9,940 Deferred tax assets -- 14,955
Other assets 110,404 69,846 --------------- --------------- Total
assets $926,381 $428,606 =============== ===============
Liabilities and Stockholders' Equity Current liabilities: Accounts
payable $15,658 $10,447 Accrued liabilities 65,670 62,980
--------------- --------------- Total current liabilities 81,328
73,427 --------------- --------------- Deferred rent and other
16,916 10,479 Borrowings 460,286 - Deferred tax liabilities 63,694
- --------------- --------------- Total liabilities 622,224 83,906
--------------- --------------- Commitments and contingencies
Stockholders' equity: Common stock, par value: $0.001 per share 45
45 Additional paid-in capital 267,006 284,672 Treasury stock, at
cost (201) (201) Accumulated other comprehensive income 1,885 1,607
Retained earnings 35,422 58,577 --------------- ---------------
Total stockholders' equity 304,157 344,700 ---------------
--------------- Total liabilities and stockholders' equity $926,381
$428,606 =============== =============== DATASOURCE: Kyphon Inc.
CONTACT: Investors and Media, Julie D. Tracy, Vice President, Chief
Communications Officer, +1-408-548-6687, or Web site:
http://www.kyphon.com/
Copyright
Kyphon (MM) (NASDAQ:KYPH)
Gráfica de Acción Histórica
De May 2024 a Jun 2024
Kyphon (MM) (NASDAQ:KYPH)
Gráfica de Acción Histórica
De Jun 2023 a Jun 2024