(Source: Business Wire)

Orthofix International N.V. (NASDAQ:OFIX) (the Company) today announced
its results for the third quarter ended September 30, 2009. Total
revenue was $135.1 million, which was an increase of 4% over the third
quarter of 2008. Excluding the unfavorable $3.6 million impact of
foreign currency on third quarter sales, revenue increased 7% on a
constant currency basis.
Reported third quarter net income totaled $6.2 million, or $0.36 per
share. This compared with a reported loss of $237.3 million, or ($13.87)
per share, in the third quarter of the prior year. Excluding certain
items summarized in the table below, third quarter adjusted net income
was $7.7 million, or $0.44 per share.
The Company's third quarter operating income was $17.8 million, or 13.1%
of total revenue, compared with an operating loss of $289.5 million in
the prior year. Excluding certain items summarized in the table below,
third quarter adjusted operating income was $19.1 million, or 14.2% of
revenue, compared to $14.4 million, or 11.1% of revenue in the prior
year.
"Our third quarter results reflected continued growth in each of our
core businesses on a constant currency basis. This included another
strong performance from our spinal implants division, which generated
20% sales growth from our cervical and lumbar implant devices. This
increase was driven primarily by the success of recent new product
introductions, including the Firebird pedicle screw system
and Pillar SA interbody device," said President and CEO Alan
Milinazzo. "During the quarter the Musculoskeletal Transplant Foundation
continued to increase its production capacity of our new stem cell-based
allograft, Trinity® Evolution, to a point where
it met, and exceeded, the production levels included in our original
commercialization plans. Additionally, as a result of continued strong
cash generation during the third quarter, this month we made another $5
million debt repayment ahead of schedule."
Guidance
As a result of certain items impacting Orthofix's actual third quarter
and estimated fourth quarter tax rates, the Company raised its full-year
tax rate guidance to a new range of 37%-39%. Additionally, the Company
now expects to incur approximately $800,000 in fourth quarter legal
costs associated with an ongoing investigation of the bone growth
stimulation industry. The Company did not revise its operating
expectations, and reiterated its full-year revenue guidance of $535-$545
million, its gross profit margin guidance of 74%-75%, its operating
profit margin guidance of 11%-12%, and its EBITDA guidance of $93-98
million. Additionally, the Company reiterated its expectations for
8%-12% full-year revenue growth and fourth quarter operating
profitability in its spinal implants division.
Non-GAAP Performance Measures
The first table below presents a reconciliation of third quarter net
income calculated in accordance with generally accepted accounting
principles (GAAP) to a non-GAAP performance measure, referred to as
"adjusted net income", that excludes from net income the items specified
in the table. The second table below presents a reconciliation of
operating income calculated in accordance with GAAP to a non-GAAP
measure, referred to as "adjusted operating income", that excludes from
operating income the items specified in the table. Additionally a
reconciliation between third quarter net income calculated in accordance
with GAAP and a non-GAAP measure, referred to as "Consolidated EBITDA",
are included in the Regulation G Supplemental Information Schedule
attached to this release. Management believes it is important to provide
investors with the same non-GAAP metrics it uses to supplement
information regarding the performance and underlying trends of
Orthofix's business operations in order to facilitate comparisons to its
historical operating results and internally evaluate the effectiveness
of the Company's operating strategies. A more detailed explanation of
the items in the table below that are excluded from GAAP net income, as
well as why management believes the non-GAAP measures are useful to
them, is included in the Regulation G Supplemental Information schedule
attached to this press release.
Third Quarter Adjusted Net Income Q309 Q308
($000's) EPS ($000's) EPS
Reported GAAP net income/(loss) $6,188 $0.36 ($237,251) ($13.87)
Specified Items:
Strategic investments $450 $0.02 $320 $0.02
Reorganization/consolidation costs $376 $0.02 $1,501 $0.09
Foreign exchange loss $501 $0.03 $1,457 $0.08
Unrealized, non-cash loss on interest rate swap $137 $0.01 --- ---
Asset impairment & inventory reserve --- --- $237,689 $13.90
Credit agreement amendment costs --- --- $3,579 $0.21
Adjusted net income $7,652 $0.44 $7,295 $0.43
NOTE: Some calculations may be impacted by rounding
-------------------------------------------------------------------------------
Third Quarter Adjusted Operating Income Q309 Q308
($000's) ($000's)
Reported GAAP operating income/(loss) $17,751 ($289,517)
Specified Items:
Strategic investments $750 $500
Reorganization/consolidation costs $627 $2,408
Asset impairment & inventory reserve --- $301,023
Adjusted operating income $19,128 $14,414
Adjusted operating income as a percent of revenue 14.2% 11.1%
-------------------------------------------------------------------------------
Revenue
Total third quarter sales in the Company's spine sector were up 11%
year-over-year, to $68.1 million. Spine stimulation revenue increased
12%, to $39.6 million due to the continued success of the Company's
devices, which include the only FDA-approved stimulator for the cervical
spine. Spinal implant and biologic revenue was $28.5 million, which was
10% higher than the third quarter of 2008. The year-over-year growth in
spinal implant and biologic revenue was primarily due to a 20% increase
in U.S. sales of lumbar and cervical spine implant devices, partially
offset by a 19% decrease in revenue from biologics. The growth in sales
of lumbar and cervical spine implant devices was driven primarily by the
Company's recent introductions of the Firebird pedicle screw
system and Pillar SA interbody device. The decrease in
biologics revenue from the spinal implants division was a result of the
transition to Trinity® Evolution from the
Company's prior stem cell-based allograft. During the third quarter,
sales of Trinity® Evolution in the spine division
totaled approximately $3.5 million. While the average sales price for
the new allograft is approximately the same as the previous product,
under the terms of the Company's contractual arrangement with its new
supplier, the Musculoskeletal Transplant Foundation (MTF), the Company
records 70% of the sales price of the new Trinity® Evolution
allograft versus previously recording 100% of the sales price of the
prior product. The Company does not purchase inventory of Trinity®
Evolution and so does not incur any associated cost of
sales. As such, the gross profit margin for the new allograft is 100% of
the recorded revenue, which compares favorably to the gross profit
margin of approximately 50% for the prior allograft. Orthofix began the
full market release of Trinity® Evolution, which
was developed in collaboration with MTF, on July 1st of this
year.
Reported third quarter revenue in the Company's orthopedic business was
$33.3 million, which was a decrease of 2%, but represented growth of 6%
on a constant currency basis, compared with the prior year. The constant
currency revenue growth was driven primarily by increases in global
sales of deformity correction and external fixation devices of 36% and
6%, respectively, as well as 15% growth in the global sales of
Physio-Stim bone growth stimulation devices. Additionally,
the Company reported approximately $640,000 in sales of Trinity®
Evolution in its orthopedic business.
Sports medicine revenue in the third quarter grew 4% compared with 2008,
to a record $24.7 million. This growth was driven by an 8% increase in
U.S. revenue from the Company's core bracing and cold therapy products,
which was a reflection of the recent expansion of certain product lines,
including soft goods and spine bracing, as well as bracing for the upper
extremities and the ankles and feet.
Gross Margin
The gross profit margin in the third quarter of 2009 was 76.3%, which
was 13.4 percentage points higher than the third quarter of 2008. The
year-over-year improvement is primarily due to an $11.5 million
inventory reserve taken in the third quarter of 2008. Additionally, the
gross margin in the third quarter of 2009 increased due to a higher mix
of revenue from the Company's higher margin spine stimulation and spinal
implants businesses.
Operating Expenses
Third quarter sales and marketing (S&M) expenses as a percent of revenue
increased 190 basis points year-over-year, to 40.7%. The higher S&M
ratio was due primarily to an increase in commission expenses reflecting
the implementation of sales programs with new distributor partners.