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Quotes & Info
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| IART > SEC Filings for IART > Form 10-Q on 7-Nov-2008 | All Recent SEC Filings |
7-Nov-2008
Quarterly Report
Our objective is to continue to build a customer-focused and profitable medical
device company by developing or acquiring innovative medical devices and other
products to sell through our sales channels. Our strategy therefore entails
substantial growth in revenues through both internal means - through launching
new and innovative products and selling existing products more intensively - and
by acquiring existing businesses or already successful product lines.
We aim to achieve this growth in revenues while maintaining strong financial
results. While we pay attention to any meaningful trend in our financial
results, we pay particular attention to measurements that are indicative of
long-term profitable growth. These measurements include revenue growth (derived
through acquisitions and products developed internally), gross margins on total
revenues, operating margins (which we aim to continually expand on as we
leverage our existing infrastructure), and earnings per diluted share of common
stock.
ACQUISITIONS
Our strategy for growing our business includes the acquisition of complementary
product lines and companies. Our recent acquisitions of businesses, assets and
product lines may make our financial results for the nine months ended
September 30, 2008 not directly comparable to those of the corresponding
prior-year period. See Note 2 to the unaudited condensed consolidated financial
statements for a further discussion.
RESULTS OF OPERATIONS
Net loss for the three months ended September 30, 2008 was $(15.3) million, or
$(0.54) per diluted share, as compared with net income of $9.7 million, or $0.33
per diluted share, for the three months ended September 30, 2007.
Net income for the nine months ended September 30, 2008 was $10.1 million, or
$0.35 per diluted share, as compared with net income of $28.1 million, or $0.94
per diluted share, for the nine months ended September 30, 2007.
Executive Summary
The decrease in net income for the three and nine month periods ended
September 30, 2008 over the prior year periods resulted primarily from two
significant charges recorded in the third quarter of 2008 in the pre-tax amounts
of $25.2 million for in-process research and development related to the Theken
acquisition, and a non-cash charge of $18.0 million in connection with the chief
executive officer's stock-based compensation. The impact of these charges was
favorably offset by increases in revenues of 24% and 22% during the three and
nine-month periods ended September 30, 2008, respectively.
Our costs and expenses include the following charges (in thousands):
Three Months Ended September 30, Nine Months Ended September 30,
2008 2007 2008 2007
Acquisition-related charges $ 26,584 $ 1,239 $ 30,245 $ 2,870
Facility consolidation, manufacturing and
distribution transfer and system
integration charges 238 93 802 778
Employee termination and related costs - 130 - (29 )
Litigation settlements - 138 - 138
Charges associated with discontinued or
withdrawn product lines 1,207 - 1,207 1,456
Intangible asset impairments - - - 1,014
Charges related to restructuring European
subsidiaries - - - 335
Incremental professional and bank fees
related to the delayed 10-K filing - - 1,041 -
Stock-based compensation and other
related charges 18,356 - 18,356 -
Total $ 46,385 $ 1,600 $ 51,651 $ 6,562
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Of these amounts, $6.5 million and $4.7 million were charged to cost of product revenues in the nine-month periods ended September 30, 2008 and 2007, respectively, and the in-process research and development charge of $25.2 million was included in research and development expense in the nine-month period ended September 30, 2008. The remaining amounts, except for intangible asset amortization, were charged to selling, general and administrative expenses.
Acquisition-related charges include the in-process research and development
charge and inventory fair value purchase accounting adjustments. Employee
termination and related costs for the nine months ended September 30, 2007
reflect the reversal of previously recorded accruals for anticipated
terminations as a result of changes in estimates during the second quarter 2007.
Charges associated with discontinued or withdrawn product lines in 2008 reflect
the discontinuation of products distributed for third parties and in 2007
reflect the discontinuation of certain dural repair products. Intangible asset
impairments include termination of various trademarks for various products,
which will now be re-branded as part of Integra Pain Management, and the
impairment of certain other technology and trademarks based on business and
operating decisions during the third quarter.
We believe that, given our strategy of seeking new acquisitions and integrating
recent acquisitions, our current focus on rationalizing our existing
manufacturing and distribution infrastructure, our recent review of various
product lines in relation to our current business strategy, and a renewed focus
on enterprise business systems integrations, charges similar to those discussed
above could recur with similar materiality in the future. We believe that the
delineation of these costs provides useful information to measure the
comparative performance of our business operations across reporting periods.
Revenues and Gross Margin on Product Revenues
Our revenues and gross margin on product revenues were as follows (in
thousands):
Three Months Ended September 30, Nine Months Ended September 30,
2008 2007 2008 2007
Integra NeuroSciences $ 68,014 $ 56,678 $ 192,146 $ 176,610
Integra Orthopedics 53,848 33,035 155,996 99,483
Integra Medical Instruments 45,166 45,302 132,092 116,721
Total revenue 167,028 135,015 480,234 392,814
Cost of product revenues 64,317 50,863 184,688 152,248
Gross margin on total revenues $ 102,711 $ 84,152 $ 295,546 $ 240,566
Gross margin as a percentage of total
revenues 61 % 62 % 62 % 61 %
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THREE MONTHS ENDED SEPTEMBER 30, 2008 AS COMPARED TO THREE MONTHS ENDED
SEPTEMBER 30, 2007
Revenues and Gross Margin
For the three months ended September 30, 2008, total revenues increased by
$32.0 million, or 24%, to $167.0 million from $135.0 million for the same period
during 2007. Domestic revenues increased by $22.6 million to $128.2 million, or
77% of total revenues, for the three months ended September 30, 2008 from
$105.6 million, or 78% of total revenues, for the three months ended
September 30, 2007. International revenues increased to $38.8 million from
$29.4 million in the prior-year period, an increase of 32%.
In the neurosciences category, sales of our ultrasonic aspirator,
neuromonitoring, cranial stabilization and dural repair products led revenue
growth. In the orthopedics category, lower extremity metal implants, engineered
collagen products for dermal and nerve repair, and our Integra Mozaik bone void
filler led revenue growth. Upper extremity products declined compared to the
prior-year quarter. Theken spine products, acquired in August, contributed
$6.8 million to revenue in the quarter. Finally, in the medical instruments
category, Jarit instruments (sold primarily to hospitals) led growth, offset by
declines in Miltex instruments (sold primarily to offices) and surgical lighting
and distributed products.
Included in revenues are royalties of $2.9 million and $8.7 million,
respectively, for the three and nine months ended September 30, 2008, and
$2.5 million and $7.6 million for the three and nine months ended September 30,
2007.
We have generated our product revenue growth through acquisitions, new product
launches and increased direct sales and marketing efforts both domestically and
in Europe. We expect that our expanded domestic sales force, the continued
implementation of our direct sales strategy in Europe and sales of internally
developed and acquired products will drive our future revenue growth. We also
intend to continue to acquire businesses that complement our existing businesses
and products. Many of our recent acquisitions involve businesses or product
lines that overlap in some way with our existing products. Our sales and
marketing departments are integrating these acquisitions, and, as a result,
there has been, and we expect there will continue to be, some negative effect on
sales of our existing products that will affect our internal growth.
Gross margin increased by $18.5 million to $102.7 million for the three months
ended September 30, 2008, from $84.2 million for the same period last year.
Gross margin as a percentage of total revenue is 61% for the third quarter 2008,
compared to 62% for third quarter 2007.
Other Operating Expenses
The following is a summary of other operating expenses as a percent of total
revenues (in thousands):
Three Months Ended September 30,
2008 2007
Research and development 21 % 5 %
Selling, general and administrative 52 % 42 %
Intangible asset amortization 2 % 2 %
Total other operating expenses 75 % 49 %
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Total other operating expenses, which consist of research and development
expenses, selling, general and administrative expenses, and amortization
expenses, increased $59.8 million, or 91%, to $125.6 million in the third
quarter of 2008, compared to $65.8 million in the third quarter of 2007.
Research and development expenses in the third quarter of 2008 increased by
$28.2 million to $34.7 million, compared to $6.5 million in the same period last
year. Most of the increase was related to the $25.2 million in-process research
and development charge related to the acquisition of Theken and increased
spending on biomaterials programs, including our multi-center clinical trial in
connection with a proposed application to the FDA for approval of our DuraGen
Plus® Adhesion Barrier Matrix product in the United States. In the remainder of
2008 and for 2009, we expect to increase our research and development expenses
on activities directed toward further expanding the indications for use of our
absorbable implant technology products, including the DuraGen Plus® Adhesion
Barrier Matrix clinical trial.
Selling, general and administrative expenses in the third quarter of 2008
increased by $31.5 million to $87.7 million, or 52% of revenue, compared to
$56.2 million, or 42% of revenue, in the same period last year. The increase in
selling, general and administrative expenses over the prior year was due
primarily to an $18.0 million stock-based compensation charge in connection with
the renewal of the chief executive officer's employment agreement, increases in
finance department personnel, and expenses attributable to businesses acquired
in the last year. As we gain more leverage from our larger selling
organizations, we expect selling, general and administrative expenses to
decrease to between 38% and 40% of revenue over the remainder of 2008 and into
2009.
We intend to continue to expand our direct sales and marketing organizations in
our selling platforms and to increase corporate staff to support the recent
growth in our business, integrate acquired businesses, and improve the internal
controls over financial reporting. Additionally, we have incurred higher
operating costs in connection with our recent investments in our infrastructure,
including the continued implementation of an enterprise business system and the
expansion of our finance and accounting staff. We expect to incur costs related
to these activities for the remainder of 2008 and in 2009 as we complete these
activities.
Non-Operating Income and Expenses
The following is a summary of non-operating income and expenses (in thousands):
Three Months Ended September 30,
2008 2007
Interest income $ 399 $ 1,518
Interest expense (4,249 ) (3,863 )
Other income (expense) (409 ) (325 )
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Interest Income
Interest income decreased in the three months ended September 30, 2008 compared
to the same period last year, primarily as a result of significantly lower cash
and investment balances and lower interest rates as compared to the prior year.
Interest Expense
Interest expense increased in the three months ended September 30, 2008 compared
to the same period last year, primarily due to increased borrowings under our
bank credit agreement, offset by the repayment at maturity of our convertible
notes due in March 2008.
Our reported interest expense for the three-month period ended September 30,
2008 and 2007, includes $3.6 million and $2.2 million, respectively, of cash
interest expense on convertible notes and the senior credit facility. We
incurred approximately $9.8 million of costs in connection with the issuance of
our 2010 Notes and 2012 Notes, each as defined below, of which $7.6 million was
capitalized and which is being amortized over the term of the notes. Interest
expense for the three months ended September 30, 2008 includes $0.6 million of
non-cash amortization of debt issuance costs as compared to $0.7 million in the
same period last year.
On March 15, 2008, our 2008 Notes, as defined below, matured and, in accordance
with the terms of the 2008 Notes, we paid approximately $119.6 million and
issued 768,221 shares of our common stock in March and April 2008. We borrowed
$120.0 million under our credit facility in March 2008 in order to repay the
2008 Notes, which were entirely repaid by April 15, 2008. In July 2008, we
borrowed $80 million to fund the acquisition of Theken and for other general
corporate purposes.
Other Income
Other income (expense) for both periods represents losses resulting from changes
in foreign currency exchange rates.
Income Taxes
Three Months Ended September 30,
(in thousands) 2008 2007
Income (loss) before income taxes $ (27,150 ) $ 15,666
Income tax expense (benefit) (11,859 ) 5,993
Net income (loss) $ (15,291 ) $ 9,673
Effective tax rate (43.7 %) 38.3 %
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Our effective income tax rate for the three months ended September 30, 2008 and
2007 was 43.7% (benefit) and 38.3%, respectively. The tax benefits related to
the recorded charges for in-process research and development costs totaling
$25.2 million and the stock-based compensation charge for the renewal of the
chief executive officer's employment contract of $18.0 million. The remaining
change in the effective income tax rate year-over-year was primarily the result
of changes in the geographic mix of taxable income attributable to recently
acquired businesses and changes in valuation allowances.
Our effective tax rate may vary from period to period depending on, among other
factors, the geographic and business mix of taxable earnings and losses and
changes in tax laws and statutory tax rates in applicable jurisdictions. We
consider these factors and others, including our history of generating taxable
earnings, in assessing our ability to realize deferred tax assets.
NINE MONTHS ENDED SEPTEMBER 30, 2008 AS COMPARED TO NINE MONTHS ENDED SEPTEMBER
30, 2007
Revenues and Gross Margin
For the nine-month period ended September 30, 2008, total revenues increased 22%
to $480.2 million from $392.8 million during the prior-year period. Domestic
revenues increased by $58.9 million to $357.3 million and were 74% of total
revenues, as compared to 76% of revenues in the nine months ended September 30,
2007. International revenues increased $28.5 million to $122.9 million, an
increase of 30% compared to the same period in 2007.
In the neurosciences category, sales of our ultrasonic aspirator,
neuromonitoring, cranial stabilization and dural repair products led the revenue
growth. In the orthopedics category, lower extremity metal implants, engineered
collagen products for dermal and nerve repair, and our Integra Mozaik bone void
filler led revenue growth. Upper extremity products declined compared to the
prior year nine-month period. Theken spine products, acquired in August,
contributed $6.8 million in the nine-month period. Finally, in the medical
instruments category, Jarit instruments (sold primarily to hospitals) led
growth, offset by declines in Miltex instruments (sold primarily to offices) and
surgical lighting and distributed products.
Gross margin increased by $54.9 million to $295.5 million for the nine-month
period ended September 30, 2008, from $240.6 million for the same period last
year. Gross margin as a percentage of total revenue was 62% for the first three
quarters of 2008, compared to 61% for this same period during 2007.
Other Operating Expenses
The following is a summary of other operating expenses as a percent of total
revenues (in thousands):
Nine Months Ended September 30,
2008 2007
Research and development 10 % 5 %
Selling, general and administrative 44 % 41 %
Intangible asset amortization 2 % 2 %
Total other operating expenses 56 % 48 %
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Total other operating expenses, which consist of research and development
expenses, selling, general and administrative expenses and amortization
expenses, increased $84.3 million, or 45%, to $273.1 million in the first nine
months of 2008, compared to $188.8 million in the same period last year.
Research and development expenses in the first nine months of 2008 increased by
$31.5 million to $50.3 million, compared to $18.8 million in the same period
last year. The in-process research and development charge and routine research
and development expenses related to Theken accounted for $26.4 million of the
increase. The remaining increase relates to expanding the indications for use of
our absorbable implant technology products, including a multi-center clinical
trial in connection with a proposed application to the FDA for approval of our
DuraGen Plus®Adhesion Barrier Matrix product in the United States.
Selling, general and administrative expenses in the nine-month period ended
September 30, 2008 increased by $53.3 million to $213.6 million, compared to
$160.3 million in the same period last year. Selling expenses increased by
$18.8 million primarily due to the accelerated ramp-up in our extremities
reconstructive, intensive care unit, specialist and spine sales forces, and the
impact of acquisitions. General and administrative expenses increased by
$34.5 million in the first nine months of 2008 compared to the same period last
year primarily because of the impact of acquisitions and increases in headcount,
compensation, a non-cash charge of $18.0 million for stock-based compensation
related to the chief executive officer's employment agreement, and increased
spending on consulting services.
Amortization expense in the first nine months of 2008 decreased by $0.5 million
to $9.2 million, compared to $9.7 million in the same period last year. Included
in the 2007 amounts are $1.0 million of impairment charges.
Non-Operating Income and Expenses
The following is a summary of non-operating income and expenses (in thousands):
Nine Months Ended September 30,
2008 2007
Interest income $ 1,530 $ 2,378
Interest expense (12,725 ) (9,896 )
Other income (expense) 647 (229 )
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Interest Income
Interest income decreased in the nine-month period ended September 30, 2008,
compared to the same period last year, primarily as a result of significantly
lower interest rates period over period.
Interest Expense
Interest expense increased in the nine months ended September 30, 2008 compared
to the same period last year, primarily due to increased borrowings under our
bank credit agreement, offset by the repayment at maturity of our convertible
notes due in March 2008. In addition, in March 2008 we entered into a waiver
. . .
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