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Quotes & Info
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| IART > SEC Filings for IART > Form 10-Q on 4-Nov-2009 | All Recent SEC Filings |
4-Nov-2009
Quarterly Report
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), operating cash flows (which we aim to
increase through improved working capital management), and earnings per diluted
share of common stock.
We believe that we are particularly effective in the following aspects of our
business:
Developing metal implants for bone and joint repair, fixation and fusion.
Through acquisitions, particularly those of Theken in 2008 and Newdeal
Technologies SAS in 2005, we have acquired significant expertise in developing
metal implants for use in bone and joint repair, fixation and fusion and in
successfully bringing those products to market.
Developing, manufacturing and selling specialty regenerative technology
products. We have a broad technology platform for developing products that
regenerate or repair soft tissue and bone. We believe that we have a particular
advantage in developing, manufacturing and selling tissue repair products
derived from bovine collagen. These products comprised 23% and 22% of revenues
for the nine months ended September 30, 2009 and 2008, respectively. Products
that contain materials derived from animal sources, including food,
pharmaceuticals and medical devices, have been subject to scrutiny from the
media and regulatory authorities. Accordingly, widespread public controversy
concerning collagen products, new regulations, or a ban of our products
containing material derived from bovine tissue, could have a material adverse
effect on our current business and our ability to expand.
Acquiring and integrating new product lines and complementary businesses. Since
1999, we have acquired and integrated more than 30 product lines or businesses
through an acquisition program that focuses on acquiring companies or product
lines at reasonable valuations which complement our existing product lines or
can be used to leverage our broad technology platform in tissue regeneration and
metal implants. We also employ a team of seasoned managers and executives who
have demonstrated their ability to successfully integrate the acquired product
lines and businesses.
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, 2009 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. Since the beginning of 2008, we have
acquired the following businesses:
In August 2008, we acquired Theken Spine, LLC, Theken Disc, LLC and Therics, LLC
(collectively, "Theken") for $75.0 million in cash, acquisition expenses of
$2.4 million and working capital adjustments of $4.0 million. In addition, the
Company may pay up to an additional $121.0 million in future payments based on
the revenue performance of the business in each of the two years after closing,
including the $52.0 million that has been accrued at September 30, 2009. Theken,
based in Akron, Ohio, designs, develops and manufactures spinal fixation
products, synthetic bone substitute products and spinal arthroplasty products.
With Theken, we acquired a unique and comprehensive portfolio of spinal implant
products and a robust technology pipeline and demonstrated product development
capacity, an established network of spinal hardware distributors with
established access to the orthopedic spine market, and a strong management team
with extensive experience in the orthopedic spine market. Theken does not
currently sell its products outside of the U.S. Accordingly, we expect that the
business will benefit from Integra's large international presence. The Theken
products are now being marketed under the name Integra Spine™.
In October 2008, we acquired Integra Neurosciences Pty Ltd. in Australia and
Integra Neurosciences Pty Ltd. in New Zealand for $4.0 million (6.0 million
Australian Dollars) in cash at closing, $0.3 million in acquisition expenses and
working capital adjustments, and up to $2.1 million (3.1 million Australian
Dollars) in future payments based on the performance of business in the three
years after closing. With this acquisition of the Company's long-standing
distributor, we now have a direct selling presence in Australia and New Zealand.
In December 2008, we acquired Minnesota Scientific, Inc., doing business as
Omni-Tract Surgical ("Omni-Tract"), for $6.4 million in cash paid at closing,
310,000 unregistered shares of our common stock valued at $10.7 million (of
which 135,000 shares were issued at closing, with the remainder issued in
January 2009), working capital adjustments of $0.1 million and $0.3 million in
transaction related costs, subject to certain adjustments. Omni-Tract is a
global leader in the development and manufacture of table mounted retractors and
is based in St. Paul, Minnesota. Omni-Tract markets and sells these retractor
systems for use in vascular, bariatric, general, urologic, orthopedic, spine,
pediatric, and laparoscopic surgery. We have integrated Omni-Tract's product
lines into our combined offering of JARIT®, Padgett™, Redmond™, and Luxtec®
lines of surgical instruments and illumination systems sold by the Integra
Medical Instruments sales organization.
In August 2009, we acquired certain assets and liabilities of Innovative Spinal
Technologies, Inc. ("IST") for approximately $9.3 million in cash and
$0.2 million in acquisition expenses. IST had filed for Chapter 7 bankruptcy
protection in May 2009 and the acquisition was the result of an auction process
conducted by the bankruptcy trustee and approved by the U.S. Bankruptcy Judge
for the District of Massachusetts. IST's focus was on spinal implant products
related to minimally invasive surgery and motion preservation techniques. We
acquired three product lines, various product development assets for posterior
dynamic stabilization, various patents and trademarks, inventory, and assumed
certain of IST's patent license agreements and related obligations. These assets
and liabilities acquired did not meet the definition of a business under the
authoritative guidance for business combinations. Accordingly, the assets and
liabilities have been recognized at fair value with no related goodwill.
RESULTS OF OPERATIONS
Net income for the three months ended September 30, 2009 was $14.4 million, or
$0.49 per diluted share, as compared with net loss of $(16.9) million, or
$(0.60) per diluted share, for the three months ended September 30, 2008.
Net income for the nine months ended September 30, 2009 was $35.2 million, or
$1.20 per diluted share, as compared with net income of $4.5 million, or $0.16
per diluted share, for the nine months ended September 30, 2008.
Executive Summary
The increase in net income for the three months ended September 30, 2009 over
the prior-year period resulted primarily from decreases in operating expenses
stemming 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. In
addition, net income improved as our revenues increased by 3% in the period and
our gross margin percentage increased from 61% in the 2008 period to 63% in
2009. Offsetting this somewhat was the impact of income taxes in the third
quarter of 2009.
The increase in net income for the nine months ended September 30, 2009 over the
prior-year period resulted primarily from decreases in operating expenses
related to the significant third quarter 2008 charges described above and from a
4% increase in revenue, and an improvement in gross margin percentage from 62%
in the 2008 period to 64% in 2009.
Our costs and expenses include the following charges (in thousands):
Three Months Ended Nine Months Ended
September 30, September 30,
2009 2008 2009 2008
Acquisition-related charges $ 1,035 $ 26,131 $ 4,966 $ 26,584
Employee termination and related
costs - - 646 -
Inventory fair market value
purchase accounting adjustments - 453 - 3,661
Facility consolidation, acquisition
integration, manufacturing and
distribution transfer, and system
integration charges 96 238 488 802
Discontinued product lines - 1,207 246 1,207
Incremental professional and bank
fees related to (a) the delayed
filing of financial statements and
(b) waivers or possibility of
obtaining waivers under our
revolving credit facility - - 350 1,041
(Gain)/loss related to early
extinguishment of convertible note 207 - (916 ) -
Non-cash interest expense related
to the application of FSP APB 14-1 2,335 - 7,862 -
Stock-based compensation and other
related charges - 18,356 - 18,356
Impairment of long-lived assets 1,519 - 1,519 -
Litigation settlement (253 ) - (253 ) -
Foreign exchange loss on
intercompany loan (1) - - 1,876 -
Total $ 4,939 $ 46,385 $ 16,784 $ 51,651
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(1) This foreign exchange loss is associated with our intercompany loan set up in connection with the restructuring of a German subsidiary in the fourth quarter of 2008. Net income for the nine months ended September 30, 2009 and prior periods include foreign exchange gains and losses associated with intercompany loans not related to any restructuring.
Of these amounts, $6.1 million and $6.5 million were charged to cost of product
revenues in the nine-month periods ended September 30, 2009 and 2008,
respectively. The remaining amounts, except for intangible asset amortization
and interest expense, were charged to selling, general and administrative
expenses.
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 Nine Months Ended
September 30, September 30,
2009 2008 2009 2008
Orthopedics $ 64,135 $ 53,848 $ 193,665 $ 155,996
NeuroSciences 67,228 68,014 188,407 192,146
Medical Instruments 40,923 45,166 116,889 132,092
Total revenue 172,286 167,028 498,961 480,234
Cost of product revenues 63,021 64,317 180,974 184,688
Gross margin on total revenues $ 109,265 $ 102,711 $ 317,987 $ 295,546
Gross margin as a percentage of
total revenues 63 % 61 % 64 % 62 %
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THREE MONTHS ENDED SEPTEMBER 30, 2009 AS COMPARED TO THREE MONTHS ENDED
SEPTEMBER 30, 2008
Revenues and Gross Margin
For the three months ended September 30, 2009, total revenues increased by
$5.3 million, or 3.2%, to $172.3 million from $167.0 million for the same period
during 2008. Domestic revenues increased by $3.9 million to $132.1 million, or
77% of total revenues, for the three months ended September 30, 2009 from
$128.2 million, or 77% of total revenues, for the three months ended
September 30, 2008. International revenues increased to $40.1 million from
$38.8 million in the prior-year period, an increase of 3.4%.
Orthopedics revenues were $64.1 million, an increase of 19.1% over the
prior-year period. Most of the increase came from sales of metal spine implants
because we owned the Theken spine business for only two months during the 2008
period. Sales of metal implants for the mid- and hindfoot, engineered collagen
products for skin and wound repair, and Integra Mozaik™ collagen/ceramic bone
void filler also grew significantly.
NeuroSciences revenues were $67.2 million, down 1.2% from the prior-year period.
Sales of implants, including the DuraGen® family of products, grew
year-over-year, but were offset by declines in sales of hospital capital
equipment, particularly in our critical care monitoring systems, Radionics®
image guided surgery, and stereotactic radio surgery systems. We are uncertain
when hospitals will begin to increase spending on capital equipment relative to
the prior year; however, we expect that revenues from implants, particularly our
DuraGen® family of products, will continue to grow.
Revenues in the Medical Instruments category were $40.9 million, down 9.4% from
the prior year but up sequentially for the second quarter in a row. Sales
decreased due to eliminated distributed product lines, the discontinuation of
our Original Equipment Manufacturing ("OEM") surgical lighting line of products,
and declines in hospital-based instruments and pain management sales.
Foreign exchange fluctuations, primarily due to the weakening of the euro,
British pound and Canadian dollar versus the U.S. dollar, accounted for a
$1.7 million decrease in third quarter of 2009 revenues as compared to the same
period last year.
We expect that the following factors will continue to temper sales growth in the
short term: reduced spending by hospitals on capital equipment, the occurrence
of fewer elective surgical procedures in the current global recessionary
economic environment, our recent elimination of many of the product lines we
distributed for third parties, and the discontinuation of our OEM surgical
lighting line of products. However, we do expect these factors to produce a
benefit in our gross margin as a percentage of revenue, as most of our capital
equipment products and products distributed for third parties tend to generate
lower gross margins as compared to our other products.
While most of our products are not used in elective surgical procedures,
approximately 10% of our revenues in the three-month period ended September 30,
2009 consisted of sales of capital equipment. Given the current economic
conditions, lower hospital spending on capital equipment could continue for the
rest of 2009 and potentially beyond then. We expect to drive future revenue
growth by continuing to launch new products and acquire businesses and products
that can be sold through our existing sales organizations, and by gaining
additional market share through the expansion of our Integra Extremity
Reconstruction and Integra Spine sales organizations in the U.S. and leveraging
the distribution channels in our Integra Spine, Integra NeuroSciences, and
Integra OrthoBiologics sales organizations to broaden each organization's access
to spine surgeons. We believe that the biggest opportunities for revenue growth
exist in the extremity reconstruction and spine markets.
Gross margin increased by $6.6 million to $109.3 million for the three-month
period ended September 30, 2009, from $102.7 million for the same period last
year. Gross margin as a percentage of total revenue was 63% for the third
quarter 2009 compared to 61% for the same period last year. This increase
results from a higher portion of product sales coming from higher margin
implants, particularly spine and extremity reconstruction, in combination with
reduced sales of lower margin instrument, distributed and capital products,
partially offset by an impairment of technology assets of $0.9 million and
increased reserves. In addition, the 2009 period contains less inventory
purchase accounting adjustments, where charges of $0.6 million related to Theken
in the third quarter of 2009 compared to $1.3 million related to this
acquisition in the third quarter of 2008. The 2008 period also contained charges
related to discontinued product lines totaling $1.2 million.
We expect our consolidated gross margin to improve for the rest of 2009 as sales
of our higher gross margin implant products, particularly those from the spine
business, are expected to continue to increase as a proportion of total
revenues. Although we continuously identify and implement programs to reduce
costs at our manufacturing plants and to manage our inventory more efficiently,
gross margin improvements in our business are expected to continue to result
primarily from changes in sales mix to a larger proportion of sales of our
higher gross margin implant products.
Other Operating Expenses
The following is a summary of other operating expenses as a percent of total
revenues:
Three Months Ended September 30,
2009 2008
Research and development 7 % 21 %
Selling, general and administrative 41 % 52 %
Intangible asset amortization 2 % 2 %
Total other operating expenses 50 % 75 %
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Total other operating expenses, which consist of research and development
expenses, selling, general and administrative expenses, and amortization
expenses, decreased $40.2 million, or 32%, to $85.4 million in the third quarter
of 2009 compared to $125.6 million in the third quarter of 2008.
Research and development expenses in the third quarter of 2009 decreased by
$23.2 million to $11.5 million, compared to $34.7 million in the same period
last year. This decrease is due to a $25.2 million charge for In Process
Research and Development ("IPRD") associated with the Theken acquisition in
2008, partially offset by a $0.3 million IPRD charge in the third quarter of
2009. Excluding the IPRD charges, spending increased $1.7 million to
$11.5 million, and most of the increase in spending is attributable to our spine
business and our clinical trial to support FDA approval of expanded claims for
our INTEGRA® Dermal Regeneration Template product.
We target 2009 spending on research and development to be between 6% and 7% of
total revenues. Most of this planned spending for 2009 is concentrated on
product development efforts for our spine, neurosurgery and extremity
reconstruction product lines.
Selling, general and administrative expenses in the third quarter of 2009
decreased by $17.8 million to $69.9 million, compared to $87.7 million in the
same period last year, largely due to the 2008 non-cash charge of $18.0 million
in connection with the chief executive officer's stock-based compensation.
Selling expenses increased by $1.5 million primarily due to the increase in
revenues and the corresponding commission costs, particularly in connection with
our spine product revenues, which generate relatively higher distributor
commission costs. In addition to spine, selling expenses also increased in the
third quarter of 2009 compared to the same period last year in connection with
the acquisitions of the Integra Neurosciences Pty Ltd. in Australia and New
Zealand and Omni-Tract businesses. Excluding the stock-based compensation charge
in 2008, general and administrative costs decreased $1.2 million primarily due
to lower legal fees driven by the settlement of our Codman litigation, lower
consulting and professional fees related to our financial operations, which
offset increases related to the acquisitions of the Theken, Integra
Neurosciences Pty Ltd. in Australia and New Zealand, and Omni-Tract businesses.
We will continue to expand our direct sales organizations in our direct selling
platforms where business opportunities are most attractive, including extremity
reconstruction, and increase corporate staff to support our information systems
infrastructure to facilitate future growth.
Amortization expense in the third quarter of 2009 was $4.0 million, compared to
$3.2 million in the same period last year. Increases related to the acquisitions
of the Theken, Integra Neurosciences Pty Ltd. in Australia and New Zealand, and
Omni-Tract businesses, and $0.6 million due to the impairment of a trade name,
which were partially offset by reductions from fully amortized intangible
assets.
Non-Operating Income and Expenses
The following is a summary of non-operating income and expenses (in thousands):
Three Months Ended
September 30
2009 2008
Interest income $ 197 $ 399
Interest expense $ (5,493 ) $ (6,955 )
Other income (expense) $ (380 ) $ (409 )
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Interest Income
Interest income decreased in the three months ended September 30, 2009 compared
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