UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
DC 20549
FORM
10-Q
(Mark
one)
T
|
QUARTERLY REPORT PURSUANT TO
SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
|
For the
quarterly period ended June 30, 2008
OR
£
|
TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
|
For the
transition period from____________ to ____________.
Commission
File Number: 0-19961
ORTHOFIX
INTERNATIONAL N.V.
(Exact
name of registrant as specified in its charter)
Netherlands Antilles
|
|
N/A
|
(State
or other jurisdiction of incorporation or organization)
|
|
(I.R.S.
Employer Identification No.)
|
|
|
|
7 Abraham de Veerstraat
Curaçao
Netherlands Antilles
|
|
N/A
|
(Address
of principal executive offices)
|
|
(Zip
Code)
|
(Registrant’s
telephone number, including area code)
Indicate
by check mark whether the registrant: (1) has filed all reports
required to be filed by Section 13 or 15(d) of the Securities Exchange Act of
1934 during the preceding 12 months (or for such shorter period that the
registrant was required to file such reports), and (2) has been subject to such
filing requirements for the past 90 days.
Yes T No
£
Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, or a non-accelerated filer. See definition of
“accelerated filer and large accelerated filer” in Rule 12b-2 of the Exchange
Act. (Check one): Large Accelerated filer T Accelerated
filer £
Non-Accelerated filer £
Indicate
by check mark whether the registrant is a shell company (as defined in Rule
12b-2 of the Exchange Act). Yes £ No
T
As of
August 7, 2008, 17,099,458 shares of common stock were issued and
outstanding.
PART
I FINANCIAL INFORMATION
|
|
3
|
Item
1.
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3
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Item
2.
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21
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Item
3.
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33
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Item
4.
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34
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PART
II OTHER INFORMATION
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35
|
Item
1.
|
|
|
|
35
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Item
1A.
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37
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Item
4.
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38
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Item
6.
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39
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43
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Forward-Looking
Statements
This Form
10-Q contains forward-looking statements within the meaning of Section 21E of
the Securities Exchange Act of 1934, which relate to our business and financial
outlook and which are based on our current beliefs, assumptions, expectations,
estimates, forecasts and projections. In some cases, you can identify
forward-looking statements by terminology such as “may,” “will,” “should,”
“expects,” “plans,” “anticipates,” “believes,” “estimates,” “projects,”
“intends,” “predicts,” “potential” or “continue” or other comparable
terminology. These forward-looking statements are not guarantees of
our future performance and involve risks, uncertainties, estimates and
assumptions that are difficult to predict. Therefore, our actual
outcomes and results may differ materially from those expressed in these
forward-looking statements. You should not place undue reliance on
any of these forward-looking statements. Further, any forward-looking
statement speaks only as of the date on which it is made, and we undertake no
obligation to update any such statement to reflect new information, the
occurrence of future events or circumstances or otherwise.
Factors
that could cause actual results to differ materially from those indicated by the
forward-looking statements or that could contribute to such differences include,
but are not limited to, unanticipated expenditures, changing relationships with
customers, suppliers and strategic partners, unfavorable results in litigation
matters, risks relating to the protection of intellectual property, changes to
the reimbursement policies of third parties, changes to governmental regulation
of medical devices, the impact of competitive products, changes to the
competitive environment, the acceptance of new products in the market,
conditions of the orthopedic industry and the economy, currency or interest rate
fluctuations and the other risks described under Item 1A – “Business – Risk
Factors” in our Annual Report on Form 10-K for the fiscal year ended December
31, 2007 and Part II, Item 1A – “Risk Factors” in this Form
10-Q.
PART
I
|
FINANCIAL
INFORMATION
|
Item
1. Condensed Consolidated
Financial Statements
CONDENSED
CONSOLIDATED BALANCE SHEETS
(U.S.
Dollars, in thousands except share data)
|
|
June
30,
|
|
|
December
31,
|
|
|
|
2008
|
|
|
2007
|
|
Assets
|
|
(Unaudited)
|
|
|
(Note
2)
|
|
Current
assets:
|
|
|
|
|
|
|
Cash
and cash equivalents
|
|
$ |
16,845 |
|
|
$ |
25,064 |
|
Restricted
cash
|
|
|
11,709 |
|
|
|
16,453 |
|
Trade
accounts receivable, net
|
|
|
119,097 |
|
|
|
108,900 |
|
Inventories,
net
|
|
|
113,333 |
|
|
|
93,952 |
|
Deferred
income taxes
|
|
|
11,373 |
|
|
|
11,373 |
|
Prepaid
expenses and other current assets
|
|
|
28,858 |
|
|
|
25,035 |
|
Total
current assets
|
|
|
301,215 |
|
|
|
280,777 |
|
Investments
|
|
|
4,427 |
|
|
|
4,427 |
|
Property,
plant and equipment, net
|
|
|
35,255 |
|
|
|
33,444 |
|
Patents
and other intangible assets, net
|
|
|
223,181 |
|
|
|
230,305 |
|
Goodwill
|
|
|
318,769 |
|
|
|
319,938 |
|
Deferred
taxes and other long-term assets
|
|
|
16,750 |
|
|
|
16,773 |
|
|
|
|
|
|
|
|
|
|
Total
assets
|
|
$ |
899,597 |
|
|
$ |
885,664 |
|
Liabilities
and shareholders’ equity
|
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
|
|
Bank
borrowings
|
|
$ |
8,236 |
|
|
$ |
8,704 |
|
Current
portion of long-term debt
|
|
|
3,340 |
|
|
|
3,343 |
|
Trade
accounts payable
|
|
|
28,606 |
|
|
|
24,715 |
|
Other
current liabilities
|
|
|
31,278 |
|
|
|
36,544 |
|
Total
current liabilities
|
|
|
71,460 |
|
|
|
73,306 |
|
Long-term
debt
|
|
|
289,242 |
|
|
|
294,588 |
|
Deferred
income taxes
|
|
|
74,809 |
|
|
|
75,908 |
|
Other
long-term liabilities
|
|
|
12,039 |
|
|
|
7,922 |
|
Total
liabilities
|
|
|
447,550 |
|
|
|
451,724 |
|
|
|
|
|
|
|
|
|
|
Contingencies
(Note 17)
|
|
|
|
|
|
|
|
|
Shareholders’
equity:
|
|
|
|
|
|
|
|
|
Common
shares (17,090,701 and 17,038,304 shares issued at June 30, 2008 and
December 31, 2007, respectively)
|
|
|
1,710 |
|
|
|
1,704 |
|
Additional
paid-in capital
|
|
|
163,944 |
|
|
|
157,349 |
|
Retained
earnings
|
|
|
267,615 |
|
|
|
258,201 |
|
Accumulated
other comprehensive income
|
|
|
18,778 |
|
|
|
16,686 |
|
Total
shareholders’ equity
|
|
|
452,047 |
|
|
|
433,940 |
|
|
|
|
|
|
|
|
|
|
Total
liabilities and shareholders’ equity
|
|
$ |
899,597 |
|
|
$ |
885,664 |
|
The
accompanying notes form an integral part of these condensed consolidated
financial statements.
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
FOR
THE THREE AND SIX MONTHS ENDED JUNE 30, 2008 AND 2007
(Unaudited,
U.S. Dollars, in thousands except share and per share
data)
|
|
Three Months Ended
|
|
|
Six Months Ended
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
sales
|
|
$ |
130,039 |
|
|
$ |
123,336 |
|
|
$ |
258,071 |
|
|
$ |
240,368 |
|
Cost
of sales
|
|
|
35,048 |
|
|
|
33,008 |
|
|
|
69,286 |
|
|
|
63,804 |
|
Gross
profit
|
|
|
94,991 |
|
|
|
90,328 |
|
|
|
188,785 |
|
|
|
176,564 |
|
Operating
expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sales
and marketing
|
|
|
53,246 |
|
|
|
47,310 |
|
|
|
103,442 |
|
|
|
91,893 |
|
General
and administrative
|
|
|
18,779 |
|
|
|
16,806 |
|
|
|
40,959 |
|
|
|
32,711 |
|
Research
and development
|
|
|
6,599 |
|
|
|
6,023 |
|
|
|
12,953 |
|
|
|
12,360 |
|
Amortization
of intangible assets
|
|
|
4,830 |
|
|
|
4,571 |
|
|
|
9,873 |
|
|
|
9,039 |
|
Gain
on sale of Pain Care® operations
|
|
|
- |
|
|
|
- |
|
|
|
(1,570 |
) |
|
|
- |
|
|
|
|
83,454 |
|
|
|
74,710 |
|
|
|
165,657 |
|
|
|
146,003 |
|
Operating
income
|
|
|
11,537 |
|
|
|
15,618 |
|
|
|
23,128 |
|
|
|
30,561 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other
income (expense)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
(expense) income, net
|
|
|
(4,069 |
) |
|
|
(5,869 |
) |
|
|
(9,459 |
) |
|
|
(11,534 |
) |
Other,
net
|
|
|
591 |
|
|
|
314 |
|
|
|
1,085 |
|
|
|
(242 |
) |
Other
income (expense), net
|
|
|
(3,478 |
) |
|
|
(5,555 |
) |
|
|
(8,374 |
) |
|
|
(11,776 |
) |
Income
before minority interests and income taxes
|
|
|
8,059 |
|
|
|
10,063 |
|
|
|
14,754 |
|
|
|
18,785 |
|
Minority
interests
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(43 |
) |
Income
before income taxes
|
|
|
8,059 |
|
|
|
10,063 |
|
|
|
14,754 |
|
|
|
18,742 |
|
Income
tax expense
|
|
|
(2,251 |
) |
|
|
(2,874 |
) |
|
|
(5,340 |
) |
|
|
(5,286 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
income
|
|
$ |
5,808 |
|
|
$ |
7,189 |
|
|
$ |
9,414 |
|
|
$ |
13,456 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
income per common share - basic
|
|
$ |
0.34 |
|
|
$ |
0.43 |
|
|
$ |
0.55 |
|
|
$ |
0.82 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
income per common share - diluted
|
|
$ |
0.34 |
|
|
$ |
0.43 |
|
|
$ |
0.55 |
|
|
$ |
0.80 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted
average number of common shares - basic
|
|
|
17,090,217 |
|
|
|
16,533,646 |
|
|
|
17,088,735 |
|
|
|
16,499,299 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted
average number of common shares - diluted
|
|
|
17,116,015 |
|
|
|
16,819,166 |
|
|
|
17,240,004 |
|
|
|
16,852,769 |
|
The
accompanying notes form an integral part of these condensed consolidated
financial statements.
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
FOR
THE SIX MONTHS ENDED JUNE 30, 2008 AND 2007
(Unaudited,
U.S. Dollars, in thousands)
|
|
2008
|
|
|
2007
|
|
|
|
|
|
|
|
|
Cash
flows from operating activities:
|
|
|
|
|
|
|
Net
income
|
|
$ |
9,414 |
|
|
$ |
13,456 |
|
Adjustments
to reconcile net income to net cash provided by operating
activities:
|
|
|
|
|
|
|
|
|
Depreciation
and amortization
|
|
|
14,777 |
|
|
|
13,958 |
|
Amortization
of debt costs
|
|
|
632 |
|
|
|
203 |
|
Provision
for doubtful accounts
|
|
|
3,019 |
|
|
|
2,004 |
|
Deferred
taxes
|
|
|
- |
|
|
|
(3,103 |
) |
Share-based
compensation
|
|
|
4,657 |
|
|
|
5,121 |
|
Minority
interest
|
|
|
235 |
|
|
|
(10 |
) |
Amortization
of step up of fair value in inventory
|
|
|
242 |
|
|
|
1,860 |
|
Gain
on sale of Pain Care® operations
|
|
|
(1,570 |
) |
|
|
- |
|
Other
|
|
|
515 |
|
|
|
(1,368 |
) |
Change
in operating assets and liabilities:
|
|
|
|
|
|
|
|
|
Restricted
cash
|
|
|
4,772 |
|
|
|
(1,219 |
) |
Accounts
receivable
|
|
|
(10,630 |
) |
|
|
(14,120 |
) |
Inventories
|
|
|
(16,734 |
) |
|
|
(15,682 |
) |
Prepaid
expenses and other current assets
|
|
|
(4,486 |
) |
|
|
(2,890 |
) |
Accounts
payable
|
|
|
3,250 |
|
|
|
2,265 |
|
Other
current liabilities
|
|
|
(5,839 |
) |
|
|
1,282 |
|
Net
cash provided by operating activities
|
|
|
2,254 |
|
|
|
1,757 |
|
|
|
|
|
|
|
|
|
|
Cash
flows from investing activities:
|
|
|
|
|
|
|
|
|
Payments
made in connection with acquisitions and investments, net of cash
acquired
|
|
|
- |
|
|
|
(1,456 |
) |
Capital
expenditures
|
|
|
(12,150 |
) |
|
|
(17,123 |
) |
Proceeds
from sale of Pain Care® operations
|
|
|
5,980 |
|
|
|
- |
|
Net
cash used in investing activities
|
|
|
(6,170 |
) |
|
|
(18,579 |
) |
|
|
|
|
|
|
|
|
|
Cash
flows from financing activities:
|
|
|
|
|
|
|
|
|
Net
proceeds from issue of common shares
|
|
|
1,922 |
|
|
|
2,964 |
|
Repayments
of long-term debt
|
|
|
(5,351 |
) |
|
|
(5,649 |
) |
Proceeds
from (repayments of) bank borrowings, net
|
|
|
(1,131 |
) |
|
|
8,438 |
|
Tax
benefit on non-qualified stock options
|
|
|
22 |
|
|
|
694 |
|
Net
cash (used in) provided by financing activities
|
|
|
(4,538 |
) |
|
|
6,447 |
|
Effect
of exchange rate changes on cash
|
|
|
235 |
|
|
|
178 |
|
Net
decrease in cash and cash equivalents
|
|
|
(8,219 |
) |
|
|
(10,197 |
) |
Cash
and cash equivalents at the beginning of the year
|
|
|
25,064 |
|
|
|
25,881 |
|
Cash
and cash equivalents at the end of the period
|
|
$ |
16,845 |
|
|
$ |
15,684 |
|
The
accompanying notes form an integral part of these condensed consolidated
financial statements.
NOTES
TO THE CONDENSED UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS
Orthofix
International N.V. (the “Company”) is a multinational corporation principally
involved in the design, development, manufacture, marketing and distribution of
medical devices, principally for the orthopedic products market.
NOTE
2:
|
BASIS
OF PRESENTATION
|
The
accompanying unaudited Condensed Consolidated Financial Statements have been
prepared in accordance with accounting principles generally accepted in the
United States for interim financial information and with the instructions to
Form 10-Q and Rule 10-01 of Regulation S-X. Pursuant to these rules
and regulations, certain information and note disclosures, normally included in
financial statements prepared in accordance with accounting principles generally
accepted in the United States, have been condensed or omitted. In the
opinion of management, all adjustments (consisting of normal recurring items)
considered necessary for a fair presentation have been
included. Operating results for the three and six months ended June
30, 2008 are not necessarily indicative of the results that may be expected for
the year ending December 31, 2008. The balance sheet at December 31,
2007 has been derived from the audited financial statements at that date but
does not include all of the information and footnotes required by accounting
principles generally accepted in the United States for complete financial
statements. For further information, refer to the Consolidated
Financial Statements and Notes thereto of the Company’s Annual Report on Form
10-K for the fiscal year ended December 31, 2007.
NOTE
3:
|
RECENTLY
ISSUED ACCOUNTING STANDARDS
|
In
December 2007, the FASB ratified Emerging Issues Task Force (EITF) Issue No,
07-1, Accounting for
Collaborative Arrangements (EITF 07-1). EITF 07-1 provides guidance
related to the classification of the payments between participants, the
appropriate income statement presentation, as well as disclosures related to
certain collaborative arrangements. EITF 07-1 is effective for fiscal
years beginning after December 15, 2008 and will be adopted by the Company in
the first quarter of 2009. Unless other authoritative guidance prevails, the
Company will apply the guidance included in EITF 07-1 to collaborative
arrangements entered into in 2008.
In May
2008, the Financial Accounting Standards Board (“FASB”) issued Statement of
Financial Accounting Standards (“SFAS”) No. 162, “The Hierarchy of Generally
Accepted Accounting Principles.” The Statement identified the sources
of accounting principles and the framework for selecting the principles to be
used in the preparation of financial statements that are presented in conformity
with generally accepted accounting principles in the United
States. The Statement is effective 60 days following the SEC’s
approval of the Public Company Accounting Oversight Board amendments to AU
Section 411, “The Meaning of Present Fairly in Conformity With Generally
Accepted Accounting Principles.” We do not anticipate the adoption of
SFAS No. 162 to have a material impact on the Company’s results of operations or
financial position.
In
September 2006, the FASB issued SFAS No. 157, “Fair Value
Measurements.” The Statement defines fair value, establishes a
framework for measuring fair value in generally accepted accounting principles
and expands disclosure related to the use of fair value measures in financial
statements. The provisions of SFAS No. 157 were to be effective for
fiscal years beginning after November 15, 2007. On February 6, 2008,
the FASB agreed to defer the effective date of SFAS No. 157 for one year for
certain nonfinancial assets and nonfinancial liabilities, except those that are
recognized or disclosed at fair value in the financial statements on a recurring
basis (at least annually). Effective January 1, 2008, the Company
adopted SFAS No. 157 except as it applies to those nonfinancial assets and
nonfinancial liabilities. The adoption of SFAS No. 157 did not have a
material impact on the Company’s results of operations or financial
position.
Effective
January 1, 2008, the Company adopted SFAS No. 159, “The Fair Value Option for
Financial Assets and Financial Liabilities – including an amendment of FASB
Statement No. 115.” SFAS No. 159 allows an entity the irrevocable
option to elect fair value for the initial and subsequent measurement of certain
financial assets and liabilities under an instrument-by-instrument
election. Subsequent measurements for the financial assets and
liabilities an entity elects to fair value will be recognized in the results of
operations. SFAS No. 159 also establishes additional disclosure
requirements. The Company did not elect the fair value option under
SFAS No. 159 for any of its financial assets or liabilities upon
adoption. The adoption of SFAS No. 159 did not have a material impact
on the Company’s results of operations or financial position.
In March
2008, the FASB issued SFAS No. 161, “Disclosures about Derivative Instruments
and Hedging Activities, an amendment of FASB Statement No. 133.” SFAS
No. 161 requires entities to provide greater transparency through additional
disclosures about (a) how and why an entity uses derivative instruments, (b) how
derivative instruments and related hedged items are accounted for under SFAS No.
133 “Accounting for Derivative Instruments and Hedging Activities” and its
related interpretations, and (c) how derivative instruments and related hedged
items affect an entity’s financial position, results of operations, and cash
flows. SFAS No. 161 is effective for financial statements issued for
fiscal years and interim periods beginning after November 15, 2008. The Company
is currently evaluating the potential impact of adopting SFAS No. 161 on the
Company’s disclosures of its derivative instruments and hedging
activities.
In
December 2007, the FASB issued SFAS No. 141(R), “Business Combinations (revised
2007).” SFAS No. 141(R) amends SFAS No. 141, “Business Combinations,”
and provides revised guidance for recognizing and measuring identifiable assets
and goodwill acquired, liabilities assumed, and any noncontrolling interest in
the acquiree. It also provides disclosure requirements to enable
users of the financial statements to evaluate the nature and financial effects
of the business combination. SFAS No. 141(R) is effective for fiscal
years beginning after December 15, 2008 and is to be applied
prospectively. The Company is currently evaluating the potential
impact of adopting SFAS No. 141(R) on its consolidated financial position and
results of operations.
In
December 2007, the FASB issued SFAS No. 160, “Noncontrolling Interests in
Consolidated Financial Statements, an Amendment of ARB 51,” which establishes
accounting and reporting standards pertaining to ownership interest in
subsidiaries held by parties other than the parent, the amount of net income
attributable to the parent and to the noncontrolling interest, changes in a
parent’s ownership interest, and the valuation of any retained noncontrolling
equity investment when a subsidiary is deconsolidated. SFAS No. 160
also establishes disclosure requirements that clearly identify and distinguish
between the interests of the parent and the interests of the noncontrolling
owners. SFAS No. 160 is effective for fiscal years beginning on or
after December 15, 2008. The Company is currently evaluating the
potential impact of adopting SFAS No. 160 on its consolidated financial position
and results of operations.
NOTE
4:
|
SHARE-BASED
COMPENSATION
|
The
Company accounts for its share-based compensation plans in accordance with SFAS
No. 123(R), “Share-Based Payment”, using the modified prospective transition
method. Under SFAS No. 123(R), all share-based compensation costs are
measured at the grant date, based on the estimated fair value of the award, and
are recognized as expense in the statement of operations over the requisite
service period. Commencing in June 2007, the Company offered
restricted shares in addition to stock options as a form of share-based
compensation.
The
following table shows the detail of share-based compensation by line item in the
Condensed Consolidated Statements of Operations for the three and six months
ended June 30, 2008 and 2007:
(In
US$ thousands)
|
|
Three Months Ended
June 30,
|
|
|
Six Months Ended
June 30,
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost
of sales
|
|
$ |
79 |
|
|
$ |
91 |
|
|
$ |
192 |
|
|
$ |
180 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sales
and marketing (1)
|
|
|
590 |
|
|
|
642 |
|
|
|
774 |
|
|
|
1,193 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
General
and administrative
|
|
|
1,720 |
|
|
|
1,500 |
|
|
|
3,284 |
|
|
|
3,132 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research
and development
|
|
|
174 |
|
|
|
289 |
|
|
|
407 |
|
|
|
616 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$ |
2,563 |
|
|
$ |
2,522 |
|
|
$ |
4,657 |
|
|
$ |
5,121 |
|
|
(1)
|
There
are no performance requirements and there was no consideration received
for share-based compensation awarded to sales and marketing
employees.
|
NOTE
5:
|
RECLASSIFICATIONS
|
Certain
prior year amounts have been reclassified to conform to the 2008
presentation. The reclassifications have no effect on previously
reported net income or shareholders’ equity.
Inventories
are valued at the lower of cost or estimated net realizable value, after
provision for excess or obsolete items. Cost is determined on a
weighted-average basis, which approximates the FIFO method. The
valuation of work-in-process, finished goods, field inventory and consignment
inventory includes the cost of materials, labor and production. Field
inventory represents immediately saleable finished goods inventory that is in
the possession of the Company’s direct sales representatives.
Inventories
were as follows:
|
|
June
30,
|
|
|
December
31,
|
|
(In
US$ thousands)
|
|
2008
|
|
|
2007
|
|
|
|
|
|
|
|
|
Raw
materials
|
|
$ |
9,973 |
|
|
$ |
10,804 |
|
Work-in-process
|
|
|
7,755 |
|
|
|
6,100 |
|
Finished
goods
|
|
|
61,352 |
|
|
|
42,384 |
|
Field
inventory (as described above)
|
|
|
13,221 |
|
|
|
13,997 |
|
Consignment
inventory
|
|
|
31,851 |
|
|
|
30,560 |
|
|
|
|
124,152 |
|
|
|
103,845 |
|
Less
reserve for obsolescence
|
|
|
(10,819 |
) |
|
|
(9,893 |
) |
|
|
$ |
113,333 |
|
|
$ |
93,952 |
|
The
changes in the net carrying value of goodwill by reportable segment for the
period ended June 30, 2008 are as follows:
(In
US$ thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
At
December 31, 2007
|
|
$ |
31,793 |
|
|
$ |
136,240 |
|
|
$ |
101,322 |
|
|
$ |
50,583 |
|
|
$ |
319,938 |
|
Disposals
(1)
|
|
|
- |
|
|
|
- |
|
|
|
(2,027 |
) |
|
|
- |
|
|
|
(2,027 |
) |
Purchase
price adjustment (2)
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(365 |
) |
|
|
(365 |
) |
Foreign
currency
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
1,223 |
|
|
|
1,223 |
|
At
June 30, 2008
|
|
$ |
31,793 |
|
|
$ |
136,240 |
|
|
$ |
99,295 |
|
|
$ |
51,441 |
|
|
$ |
318,769 |
|
_____________________________________________________________________________________________
|
(1)
|
Sale
of operations relating to the Pain Care® business at Breg during the first
quarter of 2008.
|
|
(2)
|
Principally
relates to the recording of inventory at fair value in connection with the
acquisition of the remaining 38.74% of the minority interest in the
Company’s Mexican subsidiary during the first quarter of
2008.
|
(In
US$ thousands)
|
|
|
|
|
|
|
Borrowings
under line of credit
|
|
$ |
8,236 |
|
|
$ |
8,704 |
|
The
weighted average interest rates on borrowings under lines of credit as of June
30, 2008 and December 31, 2007 were 6.17% and 4.79%, respectively.
Borrowings
under lines of credit consist of borrowings in Euros. The Company had
unused available lines of credit of 2.1 million Euros ($3.3 million) and 1.3
million Euros ($2.0 million) at June 30, 2008 and December 31, 2007,
respectively, in its Italian line of credit, which gives the Company the option
to borrow amounts in Italy at rates which are determined at the time of
borrowing. This line of credit is unsecured.
(In
US$ thousands)
|
|
June 30,
2008
|
|
|
December 31,
2007
|
|
|
|
|
|
|
|
|
Long-term
obligations
|
|
$ |
292,350 |
|
|
$ |
297,700 |
|
Other
loans
|
|
|
232 |
|
|
|
231 |
|
|
|
|
292,582 |
|
|
|
297,931 |
|
Less
current portion
|
|
|
(3,340 |
) |
|
|
(3,343 |
) |
|
|
$ |
289,242 |
|
|
$ |
294,588 |
|
On
September 22, 2006 the Company’s wholly-owned U.S. holding company subsidiary,
Orthofix Holdings, Inc. (“Orthofix Holdings”), entered into a senior secured
credit facility with a syndicate of financial institutions to finance the
acquisition of Blackstone. The senior secured credit facility
provides for (1) a seven-year amortizing term loan facility of $330.0 million,
the proceeds of which, together with cash balances were used for payment of the
purchase price of Blackstone; and (2) a six-year revolving credit facility of
$45.0 million. As of June 30, 2008, the Company had no amounts
outstanding under the revolving credit facility and $292.4 million outstanding
under the term loan facility. Obligations under the senior secured
credit facility have a floating interest rate of the London Inter-Bank Offered
Rate (“LIBOR”) plus a margin or prime rate plus a margin. Currently,
the term loan is a LIBOR loan, and the margin is 1.75%, which is adjusted
quarterly based upon the leverage ratio of the Company and its
subsidiaries. In June 2008, the Company entered into an interest rate
swap agreement to manage its interest rate exposure on LIBOR borrowings; see
Note 15, Derivative Instruments, for further detail. The effective
interest rates as of June 30, 2008 and December 31, 2007 on the senior secured
credit facility were 5.1% and 6.58%, respectively.
Each of
the domestic subsidiaries of the Company (which includes Orthofix Inc., Breg
Inc., and Blackstone) and Colgate Medical Limited and Victory Medical Limited
(wholly-owned financing subsidiaries of the Company) have guaranteed the
obligations of Orthofix Holdings under the senior secured credit
facility. The obligations of the subsidiaries under their guarantees
are secured by the pledges of their respective assets.
In
conjunction with obtaining the senior secured credit facility and the amendment
thereto, the Company incurred debt issuance costs of $6.4 million. As
of June 30, 2008, $4.4 million of capitalized debt issuance costs are included
in other long-term assets compared to $5.2 million at December 31,
2007.
Certain
subsidiaries of the Company have restrictions on their ability to pay dividends
or make intercompany loan advances pursuant to the Company’s senior secured
credit facility. The net assets of Orthofix Holdings and its
subsidiaries are restricted for distributions to the parent
company. Domestic subsidiaries of the Company as parties to the
credit agreement have access to these net assets for operational
purposes. The amount of restricted net assets of Orthofix Holdings
and its subsidiaries as of June 30, 2008 is $308.7 compared to $300.7 million at
December 31, 2007.
In
addition, the Company’s senior secured credit facility contains certain
financial covenants, including a fixed charge coverage ratio and a leverage
ratio applicable to Orthofix and its subsidiaries on a consolidated
basis. A breach of any of these covenants could result in an event of
default under the credit agreement, which could permit acceleration of the debt
payments under the facility unless such breach is waived by the lenders, who are
a party to the agreement, or the agreement is
amended. Management believes the Company was in compliance
with these financial covenants as measured at June 30, 2008.
However,
in its second quarter earnings release, the Company has revised its
operating expectations for the remainder of 2008 in part as a result of
contract research and development obligations which it undertook for the
development of new products. Based on the revised operating
expectations, the Company expects to experience difficulty meeting these
financial covenants for the remainder of 2008 as measured at September 30, 2008
and December 31, 2008. If the Company is unable to meet any of the
financial covenants as measured at September 30, 2008 or December 31, 2008 (or
any future quarterly measurement date), the Company intends to seek a waiver or
amendment to the credit agreement. Any requested waivers or
amendments to the credit agreement could result in fees or additional interest
charged by the lenders for their approval. Although the
Company believes we will be able to negotiate acceptable amendments or
waivers, if necessary, there can be no assurance that we will be able to do so,
and failure to do so could result in an event of default under credit agreement,
which could have a material adverse effect on our financial
position.
For the
six months ended June 30, 2008, the Company issued 52,397 shares of common stock
upon the exercise of outstanding stock options, vesting of restricted stock, and
shares issued pursuant to its employee stock purchase plan for net proceeds of
$1.9 million.
NOTE
11:
|
COMPREHENSIVE
INCOME (LOSS)
|
Accumulated
other comprehensive income (loss) is comprised of foreign currency translation
adjustments and the effective portion of the gain (loss) for derivatives
designated and accounted for as a cash flow hedge. The components of
and changes in other comprehensive income (loss) are as follows:
(In
US$ thousands)
|
|
Foreign
Currency Translation Adjustments
|
|
|
Fair
Value of Derivatives
|
|
|
Accumulated
Other Comprehensive Income/(Loss)
|
|
Balance
at December 31, 2007
|
|
$ |
15,156 |
|
|
$ |
1,530 |
|
|
$ |
16,686 |
|
Unrealized
gain on derivative instruments, net of tax of $848
|
|
|
- |
|
|
|
1,921 |
|
|
|
1,921 |
|
Foreign
currency translation adjustment
|
|
|
171 |
|
|
|
- |
|
|
|
171 |
|
Balance
at June 30, 2008
|
|
$ |
15,327 |
|
|
$ |
3,451 |
|
|
$ |
18,778 |
|
(In
US$ thousands)
|
|
Three
Months Ended
June
30,
|
|
|
Six
Months Ended
June
30,
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
income
|
|
$ |
5,808 |
|
|
$ |
7,189 |
|
|
$ |
9,414 |
|
|
$ |
13,456 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other
comprehensive income:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized
(loss) gain on derivative instrument, net of tax
|
|
|
(903 |
) |
|
|
(5 |
) |
|
|
1,921 |
|
|
|
(208 |
) |
Foreign
currency translation adjustment
|
|
|
1,798 |
|
|
|
(624 |
) |
|
|
171 |
|
|
|
1,473 |
|
Total
comprehensive income
|
|
$ |
6,703 |
|
|
$ |
6,560 |
|
|
$ |
11,506 |
|
|
$ |
14,721 |
|
NOTE
12:
|
BUSINESS
SEGMENT INFORMATION
|
The
Company’s segment information is prepared on the same basis that the Company’s
management reviews the financial information for operational decision making
purposes. The Company is comprised of the following segments:
Domestic
Domestic
(“Domestic”) consists of operations in the United States of Orthofix Inc., which
designs, manufactures and distributes stimulation and orthopedic
products. Domestic uses both direct and distributor sales
representatives to sell Spine and Orthopedic products to hospitals, doctors and
other healthcare providers in the United States market.
Blackstone
Blackstone
(“Blackstone”) consists of Blackstone Medical, Inc., based in Springfield,
Massachusetts and its two subsidiaries, Blackstone GmbH and Goldstone GmbH.
Blackstone specializes in the design, development and marketing of spinal
implant and related human cellular and tissue based products (“HCT/P products”,
often referred to as Biologic products). Blackstone's operating loss includes
amortization of acquired intangible assets and in the second quarter of 2007, it
also includes inventory which has been stepped-up in value for the Blackstone
acquisition. Blackstone distributes its products through a network of domestic
and international distributors, sales representatives and
affiliates.
Breg
Breg
(“Breg”) consists of Breg, Inc. Breg, based in Vista, California, designs,
manufactures, and distributes orthopedic products for post-operative
reconstruction and rehabilitative patient use and sells its products through a
network of domestic and international distributors, sales representatives and
affiliates.
International
International
(“International”) consists of international operations located in Europe,
Mexico, Brazil and Puerto Rico, as well as independent distributors located
outside the United States. International uses both direct and
distributor sales representatives to sell Spine, Orthopedics, Sports Medicine,
Vascular and Other products to hospitals, doctors, and other healthcare
providers.
Group
Activities
Group
Activities are comprised of the Parent’s and Orthofix Holdings’ operating
expenses and identifiable assets.
The
following tables below present information by reportable segment for the three
and six month periods ended June 30:
For the
three month period ended June 30:
|
|
External Sales
|
|
|
|
|
(In
US$ thousands)
|
|
2008
|
|
|
|
|
|
|
|
|
|
|
Domestic
|
|
$ |
47,205 |
|
|
$ |
41,632 |
|
|
$ |
1,683 |
|
|
$ |
1,290 |
|
Blackstone
|
|
|
26,924 |
|
|
|
30,017 |
|
|
|
1,064 |
|
|
|
735 |
|
Breg
|
|
|
21,901 |
|
|
|
20,193 |
|
|
|
1,118 |
|
|
|
751 |
|
International
|
|
|
34,009 |
|
|
|
31,494 |
|
|
|
7,935 |
|
|
|
7,736 |
|
Total
|
|
$ |
130,039 |
|
|
$ |
123,336 |
|
|
$ |
11,800 |
|
|
$ |
10,512 |
|
For the
six month period ended June 30:
|
|
External Sales
|
|
|
|
|
(In
US$ thousands)
|
|
2008
|
|
|
|
|
|
|
|
|
|
|
Domestic
|
|
$ |
91,332 |
|
|
$ |
80,747 |
|
|
$ |
3,304 |
|
|
$ |
2,279 |
|
Blackstone
|
|
|
55,755 |
|
|
|
56,411 |
|
|
|
2,589 |
|
|
|
1,437 |
|
Breg
|
|
|
43,964 |
|
|
|
40,316 |
|
|
|
2,656 |
|
|
|
1,224 |
|
International
|
|
|
67,020 |
|
|
|
62,894 |
|
|
|
13,433 |
|
|
|
16,149 |
|
Total
|
|
$ |
258,071 |
|
|
$ |
240,368 |
|
|
$ |
21,982 |
|
|
$ |
21,089 |
|
The
following table presents operating income by segment for the three and six month
periods ended June 30:
Operating
Income (Loss)
|
|
Three
Months Ended
June
30,
|
|
|
Six
Months Ended
June
30,
|
|
(In
US$ thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
Domestic
|
|
$ |
15,947 |
|
|
$ |
15,348 |
|
|
$ |
30,080 |
|
|
$ |
28,074 |
|
Blackstone
|
|
|
(6,985 |
) |
|
|
(734 |
) |
|
|
(10,792 |
) |
|
|
(1,348 |
) |
Breg
|
|
|
2,696 |
|
|
|
1,770 |
|
|
|
7,067 |
|
|
|
3,327 |
|
International
|
|
|
5,147 |
|
|
|
4,516 |
|
|
|
9,710 |
|
|
|
10,594 |
|
Group
Activities
|
|
|
(4,401 |
) |
|
|
(4,410 |
) |
|
|
(12,216 |
) |
|
|
(7,909 |
) |
Eliminations
|
|
|
(867 |
) |
|
|
(872 |
) |
|
|
(721 |
) |
|
|
(2,177 |
) |
Total
|
|
$ |
11,537 |
|
|
$ |
15,618 |
|
|
$ |
23,128 |
|
|
$ |
30,561 |
|
The
following tables present sales by market sector for the three and six month
periods ended June 30, 2008 and 2007:
|
|
Sales
by Market Sector
for
the three month period ended June 30, 2008
|
|
(In
US$ thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Spine
|
|
$ |
35,430 |
|
|
$ |
26,924 |
|
|
$ |
- |
|
|
$ |
358 |
|
|
$ |
62,712 |
|
Orthopedics
|
|
|
11,775 |
|
|
|
- |
|
|
|
- |
|
|
|
21,559 |
|
|
|
33,334 |
|
Sports
Medicine
|
|
|
- |
|
|
|
- |
|
|
|
21,901 |
|
|
|
1,288 |
|
|
|
23,189 |
|
Vascular
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
3,741 |
|
|
|
3,741 |
|
Other
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
7,063 |
|
|
|
7,063 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$ |
47,205 |
|
|
$ |
26,924 |
|
|
$ |
21,901 |
|
|
$ |
34,009 |
|
|
|
130,039 |
|
|
|
Sales
by Market Sector
for
the three month period ended June 30, 2007
|
|
(In
US$ thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Spine
|
|
$ |
31,353 |
|
|
$ |
30,017 |
|
|
$ |
- |
|
|
$ |
102 |
|
|
$ |
61,472 |
|
Orthopedics
|
|
|
10,279 |
|
|
|
- |
|
|
|
- |
|
|
|
17,705 |
|
|
|
27,984 |
|
Sports
Medicine
|
|
|
- |
|
|
|
- |
|
|
|
20,193 |
|
|
|
1,129 |
|
|
|
21,322 |
|
Vascular
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
5,578 |
|
|
|
5,578 |
|
Other
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
6,980 |
|
|
|
6,980 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$ |
41,632 |
|
|
$ |
30,017 |
|
|
$ |
20,193 |
|
|
$ |
31,494 |
|
|
$ |
123,336 |
|
|
|
Sales
by Market Sector
for
the six month period ended June 30, 2008
|
|
(In
US$ thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Spine
|
|
$ |
68,803 |
|
|
$ |
55,755 |
|
|
$ |
- |
|
|
$ |
612 |
|
|
$ |
125,170 |
|
Orthopedics
|
|
|
22,529 |
|
|
|
- |
|
|
|
- |
|
|
|
40,566 |
|
|
|
63,095 |
|
Sports
Medicine
|
|
|
- |
|
|
|
- |
|
|
|
43,964 |
|
|
|
2,548 |
|
|
|
46,512 |
|
Vascular
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
9,117 |
|
|
|
9,117 |
|
Other
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
14,177 |
|
|
|
14,177 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$ |
91,332 |
|
|
$ |
55,755 |
|
|
$ |
43,964 |
|
|
$ |
67,020 |
|
|
$ |
258,071 |
|
|
|
Sales
by Market Sector
for
the six month period ended June 30, 2007
|
|
(In
US$ thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Spine
|
|
$ |
60,957 |
|
|
$ |
56,411 |
|
|
$ |
- |
|
|
$ |
253 |
|
|
$ |
117,621 |
|
Orthopedics
|
|
|
19,790 |
|
|
|
- |
|
|
|
- |
|
|
|
35,839 |
|
|
|
55,629 |
|
Sports
Medicine
|
|
|
- |
|
|
|
- |
|
|
|
40,316 |
|
|
|
2,164 |
|
|
|
42,480 |
|
Vascular
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
10,499 |
|
|
|
10,499 |
|
Other
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
14,139 |
|
|
|
14,139 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$ |
80,747 |
|
|
$ |
56,411 |
|
|
$ |
40,316 |
|
|
$ |
62,894 |
|
|
$ |
240,368 |
|
The
difference between the reported provision for income taxes and a provision
computed by applying the statutory rates applicable to each subsidiary of the
Company is primarily attributable to an unfavorable discrete tax item resulting
from a taxable gain on the sale of the Company’s Pain Care®
operations. Further, the effective tax rate has been positively
affected by the Company’s European restructuring in 2006 and a similar
transaction in 2002, whereby certain intangible assets were sold between
subsidiaries in order to optimize the Company’s supply chain. Such
assets were sold at estimates of fair value based upon valuations which remain
subject to review by the local taxing authorities. Further, the
effective tax rate has been affected by the generation of un-utilizable net
operating losses in various jurisdictions, and the Section 199 deduction related
to income attributable to production activities occurring in the United
States.
As of
June 30, 2008, the Company’s gross unrecognized tax benefit was $1.7 million
plus $0.5 million accrued for interest and penalties. The entire $1.7
million of unrecognized tax benefit would affect the Company’s effective tax
rate if recognized. The Company believes it is reasonably possible
that $1.0 million of its gross unrecognized tax benefit will decrease during the
twelve months ending December 31, 2008 if certain statutes of limitations expire
during 2008.
The
Company recognizes accrued interest and penalties related to unrecognized tax
benefits within its global operations in income tax expense. To the
extent interest and penalties are not assessed with respect to uncertain tax
positions, amounts accrued will be reduced and reflected as a reduction of the
overall income tax provision.
The
Company is subject to tax examinations in all major taxing jurisdictions in
which it operates. The Company files a consolidated income tax return
in the U.S. federal jurisdiction and numerous consolidated and separate income
tax returns in many state and foreign jurisdictions. The following table
summarizes these open tax years by major jurisdiction:
|
|
Open Tax Year
|
|
|
|
Examination
in
|
|
|
Examination
not yet
|
|
Jurisdiction
|
|
Progress
|
|
|
Initiated
|
|
|
|
|
|
|
|
|
United
States
|
|
2004-2006
|
|
|
2007
|
|
|
|
|
|
|
|
|
Various
States
|
|
1996-2005
|
|
|
1996-2007
|
|
|
|
|
|
|
|
|
Brazil
|
|
N/A
|
|
|
2004-2007
|
|
|
|
|
|
|
|
|
Cyprus
|
|
N/A
|
|
|
2005-2007
|
|
|
|
|
|
|
|
|
France
|
|
N/A
|
|
|
2002-2007
|
|
|
|
|
|
|
|
|
Germany
|
|
2003-2005
|
|
|
2006-2007
|
|
|
|
|
|
|
|
|
Italy
|
|
N/A
|
|
|
2003-2007
|
|
|
|
|
|
|
|
|
Mexico
|
|
N/A
|
|
|
2000-2007
|
|
|
|
|
|
|
|
|
Netherlands
|
|
N/A
|
|
|
2004-2007
|
|
|
|
|
|
|
|
|
Puerto
Rico
|
|
N/A
|
|
|
N/A
|
|
|
|
|
|
|
|
|
Seychelles
|
|
N/A
|
|
|
N/A
|
|
|
|
|
|
|
|
|
Switzerland
|
|
N/A
|
|
|
2004-2007
|
|
|
|
|
|
|
|
|
United
Kingdom
|
|
N/A
|
|
|
2005-2007
|
|
NOTE
14:
|
EARNINGS
PER SHARE
|
For the
three and six months ended June 30, 2008 and 2007, there were no adjustments to
net income for purposes of calculating basic and diluted net income per common
share. The following table is a reconciliation of the weighted
average shares used in the basic and diluted net income per common share
computations.
|
|
Three
Months Ended
June
30,
|
|
|
Six
Months Ended
June
30,
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted
average common shares - basic
|
|
|
17,090,217 |
|
|
|
16,533,646 |
|
|
|
17,088,735 |
|
|
|
16,499,299 |
|
Effect
of dilutive securities
|
|
|
25,798 |
|
|
|
285,520 |
|
|
|
151,269 |
|
|
|
353,470 |
|
Weighted
average common shares – diluted
|
|
|
17,116,015 |
|
|
|
16,819,166 |
|
|
|
17,240,004 |
|
|
|
16,852,769 |
|
The
Company did not include 2,147,299 and 1,073,120 options in the diluted shares
outstanding calculation for the three and six months ended June 30, 2008,
respectively, in the diluted shares outstanding calculation because there
inclusion would have been anti-dilutive or because their exercise price exceeded
the average market price of the Company’s common stock during the
period.
For the
three and six month periods ended June 30, 2007, the Company did not include
129,051 and 88,042 options, respectively, in the diluted shares outstanding
calculation because there inclusion would have been anti-dilutive or because
their exercise price exceeded the average market price of the Company’s common
stock during the period.
NOTE
15:
|
DERIVATIVE
INSTRUMENTS
|
In June
2008, the Company entered into a three year fully amortizable interest rate swap
agreement (the “Swap”) with a notional amount of $150.0 million and an
expiration date of June 30, 2011. The amount outstanding under the
Swap as of June 30, 2008 was $150.0 million. Under the Swap we will
pay a fixed rate of 3.73% and receive interest at floating rates based on the
three month LIBOR rate at each quarterly re-pricing date until the expiration of
the Swap. As of June 30, 2008 the interest rate on the debt related
to the Swap was 5.5% (3.73% plus a margin of 1.75%). Our overall
effective interest rate, including the impact of the Swap, as of June 30, 2008
on our senior secured debt was 5.1%. The instrument is designated as
a cash flow hedge. The Company recognized the unrealized gain on the
change in fair value of this swap arrangement of $0.7 million, net of tax,
within other comprehensive income for the three and six months ended June 30,
2008.
In 2006,
the Company entered into a cross-currency swap agreement to manage its foreign
currency exposure related to a portion of the Company’s intercompany receivable
of a U.S. dollar functional currency subsidiary that is denominated in
Euro. The derivative instrument, a ten-year fully amortizable
agreement with a notional amount of $63.0 million is scheduled to expire on
December 30, 2016. The instrument is designated as a cash flow
hedge. The amount outstanding under the agreement as of June 30, 2008
is $59.8 million. Under the agreement, the Company pays Euro and
receives U.S. dollars based on scheduled cash flows in the
agreement. The Company recognized an unrealized loss on the change in
fair value of this swap arrangement of $1.6 million, net of tax, within other
comprehensive income for the three months ended June 30, 2008. The
Company recognized the unrealized gain on the change in fair value of this swap
arrangement of $1.2 million, net of tax, within other comprehensive income for
the six months ended June 30, 2008.
NOTE
16:
|
FAIR
VALUE MEASUREMENTS
|
As
described in Note 3, “Recently Issued Accounting Standards,” the Company adopted
SFAS No. 157 effective January 1, 2008. SFAS No. 157 defines fair
value as the price that would be received for an asset or paid to transfer a
liability (an exit price) in the principal or most advantageous market for the
asset or liability in an orderly transaction between market participants on the
measurement date. SFAS No. 157 also describes three levels of inputs
that may be used to measure fair value:
Level 1 –
quoted prices in active markets for identical assets and
liabilities
Level 2 –
observable inputs other than quoted prices in active markets for identical
assets and liabilities
Level 3 –
unobservable inputs in which there is little or no market data available, which
require the reporting entity to develop its own assumptions
The fair
value of the Company’s financial assets and liabilities measured at fair value
on a recurring basis were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash
Equivalents
|
|
$ |
1,021 |
|
|
$ |
1,021 |
|
|
$ |
- |
|
|
$ |
- |
|
Derivative
Financial Instruments(1)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash
Flow Hedges
|
|
$ |
(7,224 |
) |
|
$ |
- |
|
|
$ |
(7,224 |
) |
|
$ |
- |
|
(1)
|
See
Note 15, “Derivative Instruments”.
|
Litigation
Effective
October 29, 2007, the Company’s subsidiary, Blackstone, entered into a
settlement agreement with respect to a patent infringement lawsuit captioned
Medtronic Sofamor Danek USA Inc., Warsaw Orthopedic, Inc., Medtronic Puerto Rico
Operations Co., and Medtronic Sofamor Danek Deggendorf, GmbH v. Blackstone
Medical, Inc., Civil Action No. 06-30165-MAP, filed on September 22, 2006
in the United States District Court for the District of Massachusetts. In that
lawsuit, the plaintiffs had alleged that (i) they were the exclusive licensees
of United States Patent Nos. 6,926,718 B1, 6,936,050 B2, 6,936,051 B2, 6,398,783
B1 and 7,066,961 B2 (the “Patents”), and (ii) Blackstone's making, selling,
offering for sale, and using within the United States of its Blackstone Anterior
Cervical Plate, 3º Anterior Cervical Plate, Hallmark Anterior Cervical Plate and
Construx Mini PEEK VBR System products infringed the Patents, and that such
infringement was willful. The Complaint requested both damages and an
injunction against further alleged infringement of the Patents. The Complaint
did not specifically state an amount of damages. Blackstone denied
infringement and asserted that the Patents were invalid. On July 20,
2007, the Company submitted a claim for indemnification from the escrow
fund established in connection with the agreement and plan of merger
between the Company, New Era Medical Corp. and Blackstone, dated as of
August 4, 2006 (the “Merger Agreement”), for any losses to the Company or
Blackstone resulting from this matter. The Company was subsequently
notified by legal counsel for the former shareholders that the representative of
the former shareholders of Blackstone has objected to the indemnification claim
and intends to contest it in accordance with the terms of the Merger
Agreement. The Company is unable to predict the outcome of the escrow
claim or to estimate the amount, if any, that may ultimately be returned to the
Company from the escrow fund. The settlement agreement is not
expected to have a material impact on the Company’s consolidated financial
position, results of operations or cash flows.
On or
about July 23, 2007, Blackstone received a subpoena issued by the
Department of Health and Human Services, Office of Inspector General, under the
authority of the federal healthcare anti-kickback and false claims
statutes. The subpoena seeks documents for the period January 1, 2000
through July 31, 2006 which is prior to Blackstone’s acquisition by the
Company. The Company believes that the subpoena concerns the
compensation of physician consultants and related matters. Blackstone
is cooperating with the government’s request and is in the process of responding
to the subpoena. The Company is unable to predict what action, if
any, might be taken in the future by the Department of Health and Human
Services, Office of Inspector General or other governmental authorities as a
result of this investigation or what impact, if any, the outcome of this matter
might have on its consolidated financial position, results of operations, or
cash flows. On September 17, 2007, the Company submitted a claim for
indemnification from the escrow fund established in connection with
the Merger Agreement for any losses to the Company or Blackstone resulting
from this matter. The Company was subsequently notified by legal
counsel for the former shareholders that the representative of the former
shareholders of Blackstone has objected to the indemnification claim and intends
to contest it in accordance with the terms of the Merger
Agreement. The Company is unable to predict the outcome of the escrow
claim or to estimate the amount, if any, that may ultimately be returned to the
Company from the escrow fund.
On or
about January 7, 2008, the Company received a federal grand jury subpoena from
the United States Attorney’s Office for the District of
Massachusetts. The subpoena seeks documents for the period January 1,
2000 through July 15, 2007 from the Company, including its
subsidiaries. The Company believes that the subpoena concerns the
compensation of physician consultants and related matters, and further believes
that it is associated with the Department of Health and Human Services, Office
of Inspector General’s investigation of such matters. The Company is
cooperating with the government’s request and is in the process of responding to
the subpoena. The Company is unable to predict what action, if any,
might be taken in the future by governmental authorities as a result of this
investigation or what impact, if any, the outcome of this matter might have on
its consolidated financial position, results of operations, or cash
flows. It is the Company’s intention to submit a claim for
indemnification from the escrow fund established in connection with the Merger
Agreement for any recoverable losses to the Company or Blackstone resulting from
this matter.
On or
about September 27, 2007, Blackstone received a federal grand jury subpoena
issued by the United States’ Attorney’s Office for the District of Nevada
(“USAO-Nevada”). The subpoena seeks documents for the period from January 1999
to the present. The Company believes that the subpoena concerns payments or
gifts made by Blackstone to certain physicians. Blackstone is cooperating with
the government’s request and is in the process of responding to the
subpoena. The Company is unable to predict what action, if any, might be
taken in the future by the USAO-Nevada or other governmental authorities as a
result of this investigation or what impact, if any, the outcome of this matter
might have on its consolidated financial position, results of operations, or
cash flows. It is the Company’s intention to submit a claim for
indemnification from the escrow fund established in connection with the Merger
Agreement for any recoverable losses to the Company or Blackstone resulting from
this matter.
On
February 29, 2008, Blackstone received a Civil Investigative Demand (“CID”) from
the Massachusetts Attorney General’s Office, Public Protection and Advocacy
Bureau, Healthcare Division. The Company believes that the CID seeks
documents concerning Blackstone’s financial relationships with certain
physicians and related matters for the period from March 2004 through the date
of issuance of the CID. The Company is cooperating with the
government’s request and is in the process of responding to the
CID. It is the Company’s intention to submit a claim for
indemnification from the escrow fund established in connection with the Merger
Agreement for any recoverable losses to the Company or Blackstone resulting from
this matter.
By order
entered on January 4, 2007, the United States District Court for the Eastern
District of Arkansas unsealed a qui tam complaint captioned Thomas v. Chan, et
al., 4:06-cv-00465-JLH, filed against Dr. Patrick Chan, Blackstone and other
defendants including another device manufacturer. A qui tam action is
a civil lawsuit brought by an individual for an alleged violation of a federal
statute, in which the U.S. Department of Justice has the right to intervene and
take over the prosecution of the lawsuit at its option. The complaint
alleges causes of action under the False Claims Act for alleged
inappropriate payments and other items of value conferred on Dr.
Chan. On December 29, 2006, the U.S. Department of Justice filed a
notice of non-intervention in the case. Plaintiff subsequently
amended the complaint to add the Company as a defendant. On
January 3, 2008, Dr. Chan pled guilty to one count of knowingly soliciting and
receiving kickbacks from a medical device distributor in a criminal matter, in
which neither the Company nor any of its business units or employees were
defendants In January 2008, Dr. Chan entered into a settlement
agreement with the plaintiff and certain governmental entities in the civil qui
tam action, and on February 21, 2008, a joint stipulation of dismissal of claims
against Dr. Chan in the action was filed with the court, which removed him as a
defendant in the action. On July 11, 2008, the court granted a motion to dismiss
the Company as a defendant in the action. Blackstone remains a defendant. The
Company believes that Blackstone has meritorious defenses to the claims alleged
and we intend to defend vigorously against this lawsuit. On September 17,
2007, the Company submitted a claim for indemnification from the escrow
fund established in connection with the Merger Agreement for any losses to
the Company or Blackstone resulting from this matter. The Company was
subsequently notified by legal counsel for the former shareholders that the
representative of the former shareholders of Blackstone has objected to the
indemnification claim and intends to contest it in accordance with the terms of
the Merger Agreement. The Company is unable to predict the outcome of
the escrow claim or to estimate the amount, if any, that may ultimately be
returned to the Company from the escrow fund.
Between
January 2007 and May 2007, Blackstone and Orthofix Inc. were named defendants,
along with other medical device manufacturers, in three civil lawsuits alleging
that Dr. Chan had performed unnecessary surgeries in three different
instances. In January 2008, the Company learned that Orthofix Inc.
was named a defendant, along with other medical device manufacturers, in a
fourth civil lawsuit alleging that Dr. Chan had performed unnecessary
surgeries. All four civil lawsuits have been served and are pending
in the Circuit Court of White County, Arkansas. The Company believes
that the Company and its subsidiaries have meritorious defenses to the claims
alleged and the Company and its subsidiaries intend to defend vigorously against
these lawsuits. On September 17, 2007, the Company submitted a
claim for indemnification from the escrow fund established in connection with
the Merger Agreement for any losses to the Company or Blackstone resulting
from one of these four civil lawsuits. The Company was subsequently
notified by legal counsel for the former shareholders that the representative of
the former shareholders of Blackstone has objected to the indemnification claim
and intends to contest it in accordance with the terms of the Merger
Agreement. The Company is unable to predict the outcome of the escrow
claim or to estimate the amount, if any, that may ultimately be returned to the
Company from the escrow fund.
Of the
total Blackstone purchase price, approximately $50.0 million was placed into an
escrow account. As described in the Agreement and Plan of Merger, the
Company can make claims for reimbursement from the escrow account for certain
defined items relating to the acquisition for which the Company is indemnified.
As described in Note 17, the Company has certain contingencies arising
from the acquisition that management expects will be reimbursable from the
escrow account should the Company have to make a payment to a third party.
The Company records the claims against the escrow in an escrow receivable
account which is included in other current assets on the consolidated balance
sheets. Because the Company believes that the settlement process of
escrow claims is complex and all claims may not be reimbursed, management has
recorded a partial reserve against the escrow receivable. Further,
management believes that the amount that it will be required to pay relating to
the contingencies will not exceed the amount of the escrow account; however,
there can be no assurance that the contingencies will not exceed the amount of
the escrow account.
In
addition to the foregoing claims, the Company has submitted claims for
indemnification from the escrow fund established in connection with the Merger
Agreement for losses that have or may result from certain claims against
Blackstone alleging that plaintiffs and/or claimants were entitled to
payments for Blackstone stock options not reflected in Blackstone's corporate
ledger at the time of Blackstone's acquisition by the Company. To date,
the representative of the former shareholders of Blackstone has not objected
to approximately $1.5 million in claims from the escrow fund, with
certain claims remaining pending.
The
Company cannot predict the outcome of any proceedings or claims made against the
Company or its subsidiaries and there can be no assurance that the ultimate
resolution of any claim will not have a material adverse impact on its
consolidated financial position, results of operations, or cash
flows.
In
addition to the foregoing, in the normal course of our business, the
Company is involved in various lawsuits from time to time and may be
subject to certain other contingencies.
United
Kingdom Payroll Taxes
In 2007,
Intavent Orthofix Limited, the Company’s UK distribution subsidiary, received an
inquiry from H.M. Revenue and Customs (HMRC) relating to the tax treatment of
gains made by UK employees on the exercise of stock options. The
Company is in the process of formulating a response to HMRC. Based on
preliminary calculations, a provision of $0.5 million has been provided, of
which the Company has paid $0.2 million. The Company cannot predict
the ultimate outcome of its discussions with HMRC.
Concentrations
of credit risk
There
have been no material changes from the information provided in the Company’s
Annual Report on Form 10-K for the fiscal year ended December 31,
2007.
NOTE
18:
|
SUBSEQUENT
EVENTS
|
On July
24, 2008, the Company entered into an agreement with Musculoskeletal Transplant
Foundation (“MTF”) to collaborate on the development and commercialization of a
new stem cell-based bone growth biologic matrix. Under the terms of
the agreement, the Company will invest up to $10.0 million in the development of
the new stem cell-based bone growth biologic matrix that will be designed to
provide the beneficial properties of an autograft in spinal and orthopedic
surgeries. After the completion of the development process, the
Company and MTF will operate under the terms of a separate commercialization
agreement. Under the terms of this 10-year agreement, MTF
will source the tissue, process it to create the bone growth matrix, and
package and deliver it in accordance with orders received directly from
customers and from the Company. The Company will have exclusive
global marketing rights for the new allograft and will receive a marketing fee
from MTF based on total sales. The Company intends to account for
this collaborative arrangement under guidance included in Emerging Issues
Task Force Issue No. 07-1 “Accounting for Collaborative Arrangements,”
unless more authoritative guidance applies. The Company currently
plans for the new matrix to be launched in the U.S. during
2009.
Item
2. Management’s Discussion and Analysis of Financial Condition
and Results of Operations
The
following discussion and analysis addresses our liquidity, financial condition,
and the results of our operations for the three and six months ended June 30,
2008 compared to our results of operations for the three and six months ended
June 30, 2007. These discussions should be read in conjunction with
our historical consolidated financial statements and related notes thereto and
the other financial information included in this Form 10-Q and in our Annual
Report on Form 10-K for the fiscal year ended December 31, 2007.
General
We are a
diversified orthopedic products company offering a broad line of surgical and
non-surgical products for the Spine, Orthopedics, Sports Medicine and Vascular
market sectors. Our products are designed to address the lifelong
bone-and-joint health needs of patients of all ages, helping them achieve a more
active and mobile lifestyle. We design, develop, manufacture, market
and distribute medical equipment used principally by musculoskeletal medical
specialists for orthopedic applications. Our main products are
invasive and minimally invasive spinal implant products and related human
cellular and tissue based products (“HCT/P products”), non-invasive bone growth
stimulation products used to enhance the success rate of spinal fusions and to
treat non-union fractures, external and internal fixation devices used in
fracture treatment, limb lengthening and bone reconstruction; and bracing
products used for ligament injury prevention, pain management and protection of
surgical repair to promote faster healing. Our products also include
a device for enhancing venous circulation, cold therapy, bone cement and devices
for removal of bone cement used to fix artificial implants and airway management
products used in anesthesia applications.
We have
administrative and training facilities in the United States and Italy and
manufacturing facilities in the United States, the United Kingdom, Italy and
Mexico. We directly distribute our products in the United States, the
United Kingdom, Italy, Germany, Switzerland, Austria, France, Belgium, Mexico,
Brazil, and Puerto Rico. In several of these and other markets, we
also distribute our products through independent distributors.
Our
condensed consolidated financial statements include the financial results of the
Company and its wholly-owned and majority-owned subsidiaries and entities over
which we have control. All intercompany accounts and transactions are
eliminated in consolidation.
Our
reporting currency is the United States Dollar. All balance sheet
accounts, except shareholders’ equity, are translated at period-end exchange
rates, and revenue and expense items are translated at weighted average rates of
exchange prevailing during the period. Gains and losses resulting
from foreign currency transactions are included in other income
(expense). Gains and losses resulting from the translation of foreign
currency financial statements are recorded in the accumulated other
comprehensive income component of shareholders’ equity.
Our
financial condition, results of operations and cash flows are not significantly
impacted by seasonality trends. However, sales associated with
products for elective procedures appear to be influenced by the somewhat lower
level of such procedures performed in the late summer. Certain of the
Breg® bracing products experience greater demand in the fall and winter
corresponding with high school and college football schedules and winter
sports. In addition, we do not believe our operations will be
significantly affected by inflation. However, in the ordinary course
of business, we are exposed to the impact of changes in interest rates and
foreign currency fluctuations. Our objective is to limit the impact
of such movements on earnings and cash flows. In order to achieve
this objective, we seek to balance non-dollar income and
expenditures. During the first six months of 2008, we have used
derivative instruments to hedge certain foreign currency fluctuation exposures
as well as interest rate exposure on LIBOR-based borrowings. See Item
3 – “Quantitative and Qualitative Disclosures About Market Risk.”
On
September 22, 2006, we completed the acquisition of Blackstone Medical, Inc.
(“Blackstone”), a privately held company specializing in the design, development
and marketing of spinal implant and related HCT/P products. The purchase price
for the acquisition was $333.0 million, subject to certain closing adjustments,
plus transaction costs and other accruals totaling approximately $12.6 million
as of June 30, 2008. The acquisition and related costs were financed with $330.0
million of senior secured term debt and cash on hand. Financing costs
were approximately $6.4 million.
Effective
with the acquisition of Blackstone, we manage our operations as four business
segments: Domestic, Blackstone, Breg, and International. Domestic
consists of operations of our subsidiary Orthofix Inc. Blackstone
consists of Blackstone’s domestic and international operations. Breg
consists of Breg Inc.’s domestic operations and international
distributors. International consists of operations which are
located in the rest of the world as well as independent export distribution
operations. Group Activities are comprised of the operating expenses
and identifiable assets of Orthofix International N.V. and its U.S. holding
company, Orthofix Holdings, Inc.
Segment
and Market Sector Revenues
The
following tables display net sales by business segment and net sales by market
sector. We keep our books and records and account for net sales,
costs of sales and expenses by business segment. We provide net sales
by market sector for information purposes only.
Business
Segment:
|
|
Three
Months Ended June 30,
|
|
(In
US$ thousands)
|
|
|
|
|
|
|
|
|
|
|
|
Percent
of
Total
Net Sales
|
|
|
|
|
|
Percent
of Total Net Sales
|
|
Domestic
|
|
$ |
47,205 |
|
|
|
36 |
% |
|
$ |
41,632 |
|
|
|
34 |
% |
Blackstone
|
|
|
26,924 |
|
|
|
21 |
% |
|
|
30,017 |
|
|
|
24 |
% |
Breg
|
|
|
21,901 |
|
|
|
17 |
% |
|
|
20,193 |
|
|
|
16 |
% |
International
|
|
|
34,009 |
|
|
|
26 |
% |
|
|
31,494 |
|
|
|
26 |
% |
Total
|
|
$ |
130,039 |
|
|
|
100 |
% |
|
$ |
123,336 |
|
|
|
100 |
% |
|
|
Six
Months Ended June 30,
|
|
(In
US$ thousands)
|
|
|
|
|
|
|
|
|
|
|
|
Percent
of
Total
Net Sales
|
|
|
|
|
|
Percent
of Total Net Sales
|
|
Domestic
|
|
$ |
91,332 |
|
|
|
35 |
% |
|
$ |
80,747 |
|
|
|
34 |
% |
Blackstone
|
|
|
55,755 |
|
|
|
22 |
% |
|
|
56,411 |
|
|
|
23 |
% |
Breg
|
|
|
43,964 |
|
|
|
17 |
% |
|
|
40,316 |
|
|
|
17 |
% |
International
|
|
|
67,020 |
|
|
|
26 |
% |
|
|
62,894 |
|
|
|
26 |
% |
Total
|
|
$ |
258,071 |
|
|
|
100 |
% |
|
$ |
240,368 |
|
|
|
100 |
% |
|
|
Three
Months Ended June 30,
|
|
(In
US$ thousands)
|
|
|
|
|
|
|
|
|
|
|
|
Percent
of
Total
Net Sales
|
|
|
|
|
|
Percent
of Total Net Sales
|
|
Spine
|
|
$ |
62,712 |
|
|
|
48 |
% |
|
$ |
61,472 |
|
|
|
50 |
% |
Orthopedics
|
|
|
33,334 |
|
|
|
26 |
% |
|
|
27,984 |
|
|
|
23 |
% |
Sports
Medicine
|
|
|
23,189 |
|
|
|
18 |
% |
|
|
21,322 |
|
|
|
17 |
% |
Vascular
|
|
|
3,741 |
|
|
|
3 |
% |
|
|
5,578 |
|
|
|
4 |
% |
Other
|
|
|
7,063 |
|
|
|
5 |
% |
|
|
6,980 |
|
|
|
6 |
% |
Total
|
|
$ |
130,039 |
|
|
|
100 |
% |
|
$ |
123,336 |
|
|
|
100 |
% |
|
|
Six
Months Ended June 30,
|
|
(In
US$ thousands)
|
|
|
|
|
|
|
|
|
|
|
|
Percent
of
Total
Net Sales
|
|
|
|
|
|
Percent
of Total Net Sales
|
|
Spine
|
|
$ |
125,170 |
|
|
|
49 |
% |
|
$ |
117,621 |
|
|
|
49 |
% |
Orthopedics
|
|
|
63,095 |
|
|
|
24 |
% |
|
|
55,629 |
|
|
|
23 |
% |
Sports
Medicine
|
|
|
46,512 |
|
|
|
18 |
% |
|
|
42,480 |
|
|
|
18 |
% |
Vascular
|
|
|
9,117 |
|
|
|
4 |
% |
|
|
10,499 |
|
|
|
4 |
% |
Other
|
|
|
14,177 |
|
|
|
5 |
% |
|
|
14,139 |
|
|
|
6 |
% |
Total
|
|
$ |
258,071 |
|
|
|
100 |
% |
|
$ |
240,368 |
|
|
|
100 |
% |
The
following table presents certain items from our Condensed Consolidated
Statements of Operations as a percent of total net sales for the periods
indicated:
|
|
Three Months Ended
June 30,
|
|
|
Six Months Ended
June 30,
|
|
|
|
2008
(%)
|
|
|
2007
(%)
|
|
|
2008
(%)
|
|
|
2007
(%)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
sales
|
|
|
100 |
|
|
|
100 |
|
|
|
100 |
|
|
|
100 |
|
Cost
of sales
|
|
|
27 |
|
|
|
27 |
|
|
|
27 |
|
|
|
27 |
|
Gross
profit
|
|
|
73 |
|
|
|
73 |
|
|
|
73 |
|
|
|
73 |
|
Operating
expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sales
and marketing
|
|
|
41 |
|
|
|
38 |
|
|
|
40 |
|
|
|
38 |
|
General
and administrative
|
|
|
14 |
|
|
|
14 |
|
|
|
16 |
|
|
|
14 |
|
Research
and development
|
|
|
5 |
|
|
|
5 |
|
|
|
5 |
|
|
|
5 |
|
Amortization
of intangible assets
|
|
|
4 |
|
|
|
4 |
|
|
|
4 |
|
|
|
4 |
|
Gain
on sale of Pain Care® operations
|
|
|
- |
|
|
|
- |
|
|
|
(1 |
) |
|
|
- |
|
Total
operating income
|
|
|
9 |
|
|
|
13 |
|
|
|
9 |
|
|
|
13 |
|
Net
income
|
|
|
4 |
|
|
|
6 |
|
|
|
4 |
|
|
|
6 |
|
Three
Months Ended June 30, 2008 Compared to Three Months Ended June 30,
2007
Net sales
increased 5% to $130.0 million for the second quarter of 2008 compared to $123.3
million for the second quarter of 2007. The impact of foreign
currency increased sales by $2.9 million during the second quarter of 2008 as
compared to the second quarter of 2007.
Sales
by Business Segment:
Net sales
in Domestic increased to $47.2 million in the second quarter of 2008 compared to
$41.6 million in the second quarter of 2007, an increase of
13%. Domestic’s net sales represented 36% of total net sales during
the second quarter of 2008 and 34% of total net sales for the second quarter of
2007. The increase in Domestic’s net sales was partially the result of a 13%
increase in sales in our Spine market sector, which was mainly driven by the
increase in sales of our Spinal-Stim® and Cervical-Stim®
products. The increase in Domestic’s net sales can also be attributed
to the 15% increase in our Orthopedic market sector as sales of our Physio-Stim®
products increased 15% when compared to the second quarter of
2007. These increases were slightly offset by a 1% decrease in sales
of external fixation products.
Domestic
Sales by Market Sector:
|
|
Net
Sales for the
Three
Months Ended June 30,
|
|
|
|
|
(In
US$ thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Spine
|
|
$ |
35,430 |
|
|
$ |
31,353 |
|
|
|
13 |
% |
Orthopedics
|
|
|
11,775 |
|
|
|
10,279 |
|
|
|
15 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$ |
47,205 |
|
|
$ |
41,632 |
|
|
|
13 |
% |
Net sales
in Blackstone decreased $3.1 million to $26.9 million in the second quarter of
2008 compared to $30.0 million in the second quarter of 2007, a decrease of
10%. Blackstone’s net sales represented 21% of total net sales during
the second quarter of 2008 and 24% during the second quarter of
2007. During the integration of Blackstone into our business we have
experienced substantial turnover of sales management and distributors which has
negatively impacted our sales during the quarter. Sales may continue
to be negatively impacted until the new distributors are established in selling
Blackstone products. These decreases have been partially offset by the increase
in sales attributable to our human cellular and tissue based products (“HCT/P
products”, often referred to as Biologic products). All of
Blackstone’s sales are recorded in our Spine market sector.
Net sales
in Breg increased $1.7 million to $21.9 million in the second quarter of 2008
compared to $20.2 million for the second quarter of 2007, an increase of
8%. Breg’s net sales represented 17% of total net sales during the
second quarter of 2008 and 16% of total net sales during the same period in
2007. The increase in Breg’s net sales was primarily due to a 17%
increase in sales of our cold therapy products when compared to the same period
in the prior year. Further, sales of our Breg® bracing products
increased 13% from the second quarter of 2007, primarily as a result of the
sales of our Fusion XT™ products. These increases were partially
offset by a decrease in sales of our pain therapy products as a result of the
sale of operations related to our Pain Care® line of ambulatory infusion pumps
during March 2008. All of Breg’s sales are recorded in our Sports
Medicine market sector.
Net sales
in International increased 8% to $34.0 million in the second quarter of 2008
compared to $31.5 million in the second quarter of
2007. International’s net sales represented 26% of our total net
sales in the second quarter of both 2008 and 2007. The impact of foreign
currency increased International net sales by 9% or $2.7 million, during the
second quarter of 2008 as compared to the second quarter of
2007. International net sales were positively impacted by an increase
in sales of our Orthopedic products which increased by 22% as compared to the
second quarter of 2007 primarily as a result of the sales of our internal
fixation products including the eight-Plate Guided Growth System®, which
increased 80%, as well as increased sales of our OSCAR, Physio-Stim® and Cemex®
products. Further, sales of Breg products within International,
included in the Sports Medicine sector, increased 14% when compared to second
quarter of 2007. Offsetting these increases, International sales in
our Vascular sector, which consists of the A-V Impulse System®, decreased $1.8
million or 33% from the second quarter of 2007 as our principal distributor for
the product, who is based in the United States, sought to reduce their inventory
balances. Sales are expected to return to higher historic levels in
the second half of 2008. Sales of distributed products, which
includes the Laryngeal Mask, remained constant at approximately $7.1
million.
International
Sales by Market Sector:
|
|
Net
Sales for the
Three
Months Ended June 30,
|
|
|
|
|
(In
US$ thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Spine
|
|
$ |
358 |
|
|
$ |
102 |
|
|
|
251 |
% |
Orthopedics
|
|
|
21,559 |
|
|
|
17,705 |
|
|
|
22 |
% |
Sports
Medicine
|
|
|
1,288 |
|
|
|
1,129 |
|
|
|
14 |
% |
Vascular
|
|
|
3,741 |
|
|
|
5,578 |
|
|
|
(33 |
)% |
Other
|
|
|
7,063 |
|
|
|
6,980 |
|
|
|
1 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$ |
34,009 |
|
|
$ |
31,494 |
|
|
|
8 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Sales
by Market Sector:
Sales of
our Spine products increased 2% to $62.7 million in the second quarter of 2008
compared to $61.5 million in the second quarter of 2007. The increase
of $1.2 million is primarily due to a 17% increase in sales of Cervical- Stim®
products as well as a 10% increase in sales of Spinal-Stim® products in the
United States. These increases were offset with a 9% decrease in
sales of Blackstone products from the second quarter of 2007 as a result of
substantial turnover of sales management and distributors in Blackstone as
previously discussed. Spine product sales were 48% and 50% of our
total net sales in the second quarter of 2008 and 2007,
respectively.
Sales of
our Orthopedic products increased 19% to $33.3 million in the second quarter of
2008 compared to $28.0 million in the second quarter of 2007. The
increase of $5.4 million can be primarily attributed to a 16% increase in sales
of our Physio-Stim® products and a 50% increase in sales of our internal
fixation devices including the eight-Plate Guided Growth
System®. Orthopedic product sales were 26% and 23% of our total net
sales in the second quarter of 2008 and 2007, respectively.
Sales of
our Sports Medicine products increased 9% to $23.2 million in the second quarter
of 2008 compared to $21.3 million in the second quarter of 2007. As
discussed above, the increase of $1.9 million is primarily due to sales of our
Breg® cold therapy and bracing products, offset by a decrease in our pain
therapy products, which can be mainly attributed to the sale of operations
relating to our Pain Care®
line in March 2008. Sports Medicine product sales were 18% and 17% of
our total net sales in the second quarter of 2008 and 2007,
respectively.
Sales of
our Vascular products, which consist of our A-V Impulse System®, decreased 33% to $3.7 million
in the second quarter of 2008 compared to $5.6 million in the second quarter of
2007 as our principal distributor for the product, who is based in the United
States, sought to reduce their inventory balances. Vascular product
sales were 3% and 4% of our total net sales in the second quarter of 2008 and
2007, respectively.
Sales of
our Other products, which include the sales of our Laryngeal Mask as well as our
Woman’s Care line, increased 1% to $7.1 million in the second quarter of 2008 as
compared to $7.0 million in the second quarter of 2007. Other
product sales were 5% and 6% of our total net sales in the second quarter of
2008 and 2007, respectively.
Gross Profit - Our gross
profit increased 5% to $95.0 million in the second quarter of 2008, from $90.3
million in the second quarter of 2007. The improvement in gross
profit can be primarily attributed to increased sales, as discussed above. Sales
of our spinal stimulation products, which are our higher margin products, were
up 13% from the same period in the prior year. These increased
margins were offset by a decline in the margins of Blackstone’s products mainly
due to the impact of a changing sales mix with a higher percentage of overall
sales coming from lower profit Blackstone international distributors and
Blackstone domestic sales of HCT/P products. Gross profit as a
percent of net sales in the second quarter of 2008 and 2007 was 73.0% compared
to 73.2% in the second quarter of 2007.
Sales and Marketing Expense -
Sales and marketing expense, which includes commissions, royalties and the bad
debt provision, increased $5.9 million, or 13%, to $53.2 million in the second
quarter of 2008 compared to $47.3 million in the second quarter of
2007. This increase is attributed to increased expense in order to
support increased sales activity, including higher commissions on higher sales,
higher commissions as a result of higher commission rates and guaranteed minimum
commissions, and additional sales and marketing structure at
Blackstone. As a percent of sales, sales and marketing expense was
40.9% in the second quarter of 2008 compared to 38.4% in the second quarter of
2007.
General and Administrative
Expense – General and administrative expense increased $2.0 million, or
12%, in the second quarter of 2008 to $18.8 million compared to $16.8 million in
the second quarter of 2007. The increase was primarily attributable
to approximately $0.7 million related to corporate reorganizations. In
addition, corporate overhead costs, including finance, accounting and legal
costs increased when compared to the prior year. General and
administrative expense as a percent of sales was 14.4% in the second quarter of
2008 compared to 13.6% in the second quarter of 2007.
Research and Development
Expense - Research and development expense increased $0.6 million in the
second quarter of 2008 to $6.6 million compared to $6.0 million in the second
quarter of 2007, primarily as a result of increased product development spending
at Blackstone. As a percent of sales, research and development
expense was 5.1% in the second quarter of 2008 compared to 4.9% in the second
quarter of 2007. For the
remainder of 2008, research and development expenses are expected to increase as
a result of the agreements the Company entered into with Musculoskeletal
Transplant Foundation (“MTF”) and Intelligent Implant Systems, LLC (“IIS”). We
expect to incur up to $10.8 million of expense related to these agreements in
2008; see Liquidity and Capital Resources for further
details.
Amortization of Intangible
Assets – Amortization of intangible assets increased $0.3 million, or 6%,
in the second quarter of 2008 to $4.8 million compared to $4.6 million in the
second quarter of 2007. This increase can be primarily attributed to
an increase in the rate of amortization at Blackstone associated with
definite-lived intangible assets obtained in the Blackstone acquisition in
September 2006.
Interest Income (Expense),
net – Interest expense, net was $4.1 million for the second quarter of
2008 compared to $5.9 million for the second quarter of
2007. Interest expense for the second quarters of 2008 and 2007
included interest expense of $3.3 million and $5.6 million, respectively,
related to the senior secured term loan used to finance the Blackstone
acquisition. This decrease can be mainly attributed to a lower
interest rate as well as less principal from the comparable period in the prior
year.
Other, net – Other, net was
income of $0.6 million for the second quarter of 2008 compared to income of $0.3
million for the second quarter of 2007. The increase can be mainly
attributed to the effect of foreign exchange.
Income Tax Expense – Our
estimated worldwide effective tax rates were 27.9% and 28.6% during the second
quarters of 2008 and 2007, respectively. The effective tax rate for the
second quarter of 2008 was positively affected by less income in the United
States, a higher tax jurisdiction.
Net Income
– Net income for the second
quarter of 2008 was $5.8 million, or $0.34 per basic and diluted share, compared
to net income of $7.2 million, or $0.43 per basic share and per diluted share,
for the second quarter of 2007. The weighted average number of basic
common shares outstanding was 17,090,217 and 16,533,646 during the second
quarters of 2008 and 2007, respectively. The weighted average number
of diluted common shares outstanding was 17,116,015 and 16,819,166 during the
second quarters of 2008 and 2007, respectively.
Six
Months Ended June 30, 2008 Compared to Six Months Ended June 30,
2007
Net sales
increased 7% to $258.1 million for the first six months of 2008 compared to
$240.4 million for the first six months of 2007. The impact of
foreign currency increased sales by $5.2 million during the first six months of
2008 as compared to the first six months of 2007.
Sales
by Business Segment:
Net sales
in Domestic increased to $91.3 million in the first six months of 2008 compared to $80.7
million in the first six months of 2007, an increase of
13%. Domestic’s net sales represented 35% of total net sales during
the first six months of 2008 and 34% of total
net sales for the first six months of 2007. The increase in
Domestic’s net sales was partially the result of a 13% increase in sales in our
Spine market sector, which was mainly driven by the increase in sales of our
Spinal-Stim® and Cervical-Stim® products. The increase in Domestic’s
net sales can also be attributed to the 14% increase in our Orthopedic market
sector as sales of our internal fixation products including our eight-Plate
Guided Growth System® increased 12%, and sales of our Physio-Stim® products
increased 12% when compared to the first six months of 2007. These
increases were partially offset by a 5% decrease in sales of external fixation
products when compared to the same period in the prior year.
Domestic
Sales by Market Sector:
|
|
Net
Sales for the
Six
Months Ended June 30,
|
|
|
|
|
(In
US$ thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Spine
|
|
$ |
68,803 |
|
|
$ |
60,957 |
|
|
|
13 |
% |
Orthopedics
|
|
|
22,529 |
|
|
|
19,790 |
|
|
|
14 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$ |
91,332 |
|
|
$ |
80,747 |
|
|
|
13 |
% |
Net sales
in Blackstone decreased to $55.8 million in the first six months of 2008
compared to $56.4 million in the first six months of 2007, a decrease of
1%. Blackstone’s net sales represented 22% of total net sales during
the first six months of 2008 and 23% during the first six months of
2007. During the integration of Blackstone into our business we have
experienced substantial turnover of sales management and distributors which has
negatively impacted our sales during the first six months. Our sales
may continue to be negatively impacted by this turnover until the new
distributors are established in selling Blackstone products. These decreases in
sales have been partially offset by the increase in sales of our human cellular
and tissue based products (“HCT/P products”, often referred to as Biologic
products). All of Blackstone’s sales are recorded in our Spine market
sector.
Net sales
in Breg increased $3.6 million to $44.0 million in the first six months of 2008
compared to $40.3 million for the first six months of 2007, an increase of
9%. Breg’s net sales represented 17% of total net sales during the
first six months of 2008 and 2007. The increase in Breg’s net sales
was primarily due to an increase in the sales of our Breg® bracing products
which increased 14% from the first six months of 2007, primarily as a result of
the sales of our Fusion XT™ products. Further, sales of our cold
therapy products increased 15% when compared to the same period in the prior
year. These increases were partially offset by a decrease in sales of
our pain therapy products as a result of the sale of operations related to our
Pain Care® line of ambulatory infusion pumps during March 2008. All
of Breg’s sales are recorded in our Sports Medicine market sector.
Net sales
in International increased 7% to $67.0 million in the first six months of 2008
compared to $62.9 million in the first six months of
2007. International’s net sales represented 26% of our total net
sales in the first six months of 2008 and 2007. The impact of foreign currency
increased International net sales by 8% or $5.0 million, during the first six
months of 2008 as compared to the first six months of 2007. The sales
of our Orthopedic products increased by 13% as compared to the first six months
of 2007 primarily as a result of the sales of our internal fixation products
including the eight-Plate Guided Growth System®, which increased 42%, as well as
increased sales of our OSCAR and Physio-Stim® products. Further,
sales of Breg products within International, included in the Sports Medicine
sector, increased 18% when compared to the first six months of
2007. International sales in our Vascular sector, which consists of
the A-V Impulse System®, decreased $1.4 million or 13% from the first six months
of 2007, as our principal distributor for the product, who is based in the
United States, sought to reduce their inventory balances. Sales are
expected to return to higher historic levels in the second half of
2008. Sales of distributed products, which includes the Laryngeal
Mask, remained constant.
International
Sales by Market Sector:
|
|
Net
Sales for the
Six
Months Ended June 30,
|
|
|
|
|
(In
US$ thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Spine
|
|
$ |
612 |
|
|
$ |
253 |
|
|
|
142 |
% |
Orthopedics
|
|
|
40,566 |
|
|
|
35,839 |
|
|
|
13 |
% |
Sports
Medicine
|
|
|
2,548 |
|
|
|
2,164 |
|
|
|
18 |
% |
Vascular
|
|
|
9,117 |
|
|
|
10,499 |
|
|
|
(13 |
)% |
Other
|
|
|
14,177 |
|
|
|
14,139 |
|
|
|
-- |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$ |
67,020 |
|
|
$ |
62,894 |
|
|
|
7 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Sales
by Market Sector:
Sales of our Spine products increased
6% to $125.2 million in the first six months of 2008 compared to $117.6 million in
the first six months of
2007. The increase of $7.5 million is primarily due to a 13% increase
in sales of spinal stimulation products in the United States. Spine
product sales were 49% of our total net sales in the first six months
of both 2008 and
2007.
Sales of
our Orthopedic products increased 13% to $63.1 million in the first six
months of 2008
compared to $55.6 million in the first six months of 2007. The
increase of $7.5 million can be mainly attributed to a 32% increase in sales of
our internal fixation devices including the eight-Plate Guided Growth
System®. Further, the 13% increase in sales of our Physio-Stim®
products also contributed to the increase in our Orthopedic
sales. Offsetting these increases, our external fixation product
sales decreased by 2%, from the first six months of 2007. Orthopedic
product sales were 24% and 23% of our total net sales in the first six
months of 2008 and
2007, respectively.
Sales of
our Sports Medicine products increased 9% to $46.5 million in the first six
months of 2008
compared to $42.5 million in the first six months of 2007. As
discussed above, the increase of $4.0 million is primarily due to sales of our
Breg® bracing products as well as our cold therapy products, offset by a
decrease in our pain therapy products, which can be mainly attributed to the
sale of operations relating to our Pain Care® line in March
2008. Sports Medicine product sales were 18% of our total net sales
in the first six months of both 2008 and 2007.
Sales of
our Vascular products, which consist of our A-V Impulse System®, decreased 13% to $9.1 million
in the first six months of 2008 compared to $10.5 million in the first six
months of 2007. Sales decreased as our principal distributor for the product in
the United States sought to reduce their inventory balances. Sales
are expected to return to higher historic levels in the second half of
2008. Vascular product sales were 4% of our total net sales in the
first six months of both 2008 and 2007.
Sales of
our Other products, which include the sales of our Laryngeal Mask as well as our
Woman’s Care line, remained flat at approximately $14.2 million in the first six
months of 2008 as compared to $14.1 million in the first six months of
2007. Other product sales were 5% and 6% of our total net sales
in the first six months of 2008 and 2007, respectively.
Gross Profit - Our gross
profit increased 7% to $188.8 million in the first six months of 2008, from
$176.6 million in the first six months of 2007. The improvement in
gross profit can be primarily attributed to increased sales, as discussed above.
Sales of our spinal stimulation products, which are our higher margin products,
were up 13% from the same period in the prior year. These increased
margins were offset by a decline in the margins of Blackstone’s products mainly
due to the impact of a changing sales mix with a higher percentage of overall
sales coming from lower profit Blackstone international distributors and
Blackstone domestic sales of HCT/P products. Further, during the six
months of 2007, we recorded a charge of $1.9 million for amortization of the
step-up in inventory associated with the Blackstone
acquisition. Since the step-up in the Blackstone inventory from
purchase accounting was fully amortized during 2007, no such amortization was
recorded during the first six months of 2008. Gross profit as a
percent of net sales in the first six months of 2008 was 73.2% compared to 73.4%
in the first six months of 2007.
Sales and Marketing Expense -
Sales and marketing expense, which includes commissions, royalties and the bad
debt provision, increased $11.5 million, or 13%, to $103.4 million in the first
six months of 2008 compared to $91.9 million in the first six months of
2007. This increase is attributed to increased expense in order to
support increased sales activity, including higher commissions on higher sales,
higher commissions as a result of higher commission rates and guaranteed minimum
commissions, and additional sales and marketing structure at
Blackstone. In addition, sales and marketing expense increased due to
costs incurred related to the completed exploration of the potential divestiture
of our orthopedic fixation business. Offsetting these increases, SFAS
123(R) expense decreased $0.4 million from the comparable period in the prior
year. As a percent of sales, sales and marketing expense was 40.1% in
the first six months of 2008 compared to 38.2% in the first six months of
2007.
General and Administrative
Expense – General and administrative expense increased $8.2 million, or
25%, in the first six months of 2008 to $41.0 million compared to $32.7 million
in the first six months of 2007. The increase was primarily
attributable to a charge of $2.8 million recorded in the first half of 2008
related to the completed exploration of the potential divestiture of our
orthopedic fixation business, as well as increased audit fees and headcount,
especially at our Brazilian and Blackstone subsidiaries. General and
administrative expense as a percent of sales was 15.9% in the first six months
of 2008 compared to 13.6% in the first six months of 2007.
Research and Development
Expense - Research and development expense increased $0.6 million in the
first six months of 2008 to $13.0 million compared to $12.4 million in the first
six months of 2007, primarily as a result of increased product development
spending at Blackstone. As a percent of sales, research and
development expense was 5.0% in the first six months compared with 5.1% in
the first six months of 2007. For the
remainder of 2008, research and development expenses are expected to increase as
a result of the agreements the Company entered into with MTF and IIS. We expect
to incur up to $10.8 million of expense related to these agreements in 2008; see
Liquidity and Capital Resources for further details.
Amortization of Intangible
Assets – Amortization of intangible assets increased approximately $0.8
million, or 9%, in the first six months of 2008 to $9.9 million compared to $9.0
million in the first six months of 2007. This increase can be
primarily attributed to an increase in the rate of amortization at Blackstone
associated with definite-lived intangible assets obtained in the Blackstone
acquisition in September 2006.
Gain on Sale of Pain Care®
Operations – Gain on sale of Pain Care® operations was $1.6 million in
the first six months of 2008 and represented the gain on the sale of operations
related to our Pain Care® line of ambulatory infusion pumps during March
2008. No such gain was recorded in the first six months of
2007.
Interest Income (Expense),
net – Interest expense, net was $9.5 million for the first six months of
2008 compared to $11.5 million for the first six months of
2007. Interest expense for the first six months of 2008 and 2007
included interest expense of $8.3 million and $11.2 million, respectively,
related to the senior secured term loan used to finance the Blackstone
acquisition. This decrease can be mainly attributed to a lower
interest rate as well as less principal from the comparable period in the prior
year.
Other, net – Other, net was
income of $1.1 million for the first six months of 2008 compared to expense of
$0.2 million for the first six months of 2007. The increase can be
mainly attributed to the effect of foreign exchange.
Income Tax Expense – Our
estimated worldwide effective tax rates were 36.2% and 28.2% during the first
six months of 2008 and 2007, respectively. The effective tax rate for the
first six months of 2008 included an unfavorable discrete item resulting from
the sale of operations related to our Pain Care® operations. Excluding this discrete
item, our effective rate was 29.9%. The effective tax rate for the
first six months of 2008 was also negatively affected by the expiration of a
U.K. tax planning strategy and the generation of unutilizable net operating
losses in various jurisdictions.
Net Income
– Net income for the first six
months of 2008 was $9.4 million, or $0.55 per basic and diluted share, compared
to net income of $13.5 million, or $0.82 per basic share and $0.80 per diluted
share, for the first six months of 2007. The weighted average number
of basic common shares outstanding was 17,088,735 and 16,499,299 during the
first six months of 2008 and 2007, respectively. The weighted average
number of diluted common shares outstanding was 17,240,004 and 16,852,769 during
the first six months of 2008 and 2007, respectively.
Liquidity
and Capital Resources
Cash and
cash equivalents at June 30, 2008 were $28.6 million, of which $11.7 million was
subject to certain restrictions under the senior secured credit agreement
described below. This compares to cash and cash equivalents of $41.5
million at December 31, 2007, of which $16.5 million was
restricted.
Net cash
provided by operating activities increased to $2.3 million for the first six
months of 2008 compared to $1.8 million provided by operating activities in the
first six months of 2007. Net cash provided by operating activities
is comprised of net income, non-cash items (including share-based compensation
and non-cash purchase accounting items from the Blackstone and Breg
acquisitions) and changes in working capital, including changes in restricted
cash. Net income decreased $4.0 million to $9.4 million for the first
six months of 2008 from net income of $13.5 million for the comparable period in
the prior year. Non-cash items for the first six months of 2008
increased $3.8 million from the first six months of 2007 primarily as a result
of an increase in the provision for bad debts which was partially offset by the
$1.6 million gain on the sale of the operations related to the Breg Pain
Care®
line. Working capital accounts consumed $29.7 million of cash in the first six
months of 2008 compared to $30.4 million in the same period in
2007. The principal uses of cash for working capital can be mainly
attributable to increases in accounts receivable and inventory to support
additional sales and certain operational initiatives. Overall
performance indicators for our two primary working capital accounts, accounts
receivable and inventory, reflect days sales in receivables of 83 days at June
30, 2008 compared to 87 days at June 30, 2007 and inventory turns
of 1.2 times at June 30, 2008 compared to 1.5 times at June 30, 2007.
The lower inventory turns and resultant higher inventory
balances reflect purchases to support Blackstone sales, support for
new spinal implant and internal fixation products, and support for additional
supply of Biologics products.
Net cash
used in investing activities was $6.2 million during the first six months of
2008 compared to $18.6 million used in investing activities during the first six
months of 2007. During the first half of 2008, we sold the operations
of our Pain Care® line of
ambulatory infusion pumps for net proceeds of $6.0 million. In the
six months ended June 30, 2008, we invested $12.2 million in capital
expenditures, of which $7.3 million were related to Blackstone and included the
acquisition of intellectual property and related technology for a next
generation spinal fixation system from IIS. During the first six
months of 2007, we invested $17.1 million in capital expenditures of which $10.4
million were related to Blackstone. We also invested $1.5 million in
subsidiaries and affiliates which was a result of adjustments in purchase
accounting related to Blackstone and a purchase of a minority interest in our
subsidiary in Mexico.
Net cash
used in financing activities was $4.5 million in the first six months of 2008
compared to $6.4 million provided in the same period of 2007. During
the first six months of 2008, we repaid approximately $5.4 million against the
principal on our senior secured term loan and repaid $1.1 million to support
working capital in our Italian subsidiary. In addition, we received
proceeds of $1.9 million from the issuance of 52,397 shares of our common stock
upon the exercise of stock options and shares issued pursuant to the employee
stock purchase plan. During the first six months of 2007, we repaid
$5.6 million against the principal on our senior secured term loan and borrowed
$8.4 million to support working capital in our Italian subsidiary. In
addition, we received proceeds of $3.0 million from the issuance of 98,907
shares of our common stock upon the exercise of stock options.
On
September 22, 2006 our wholly-owned U.S. holding company subsidiary, Orthofix
Holdings, Inc. (“Orthofix Holdings”), entered into a senior secured credit
facility with a syndicate of financial institutions to finance the acquisition
of Blackstone. The senior secured credit facility provides for (1) a
seven-year amortizing term loan facility of $330.0 million, the proceeds of
which, together with cash balances were used for payment of the purchase price
of Blackstone; and (2) a six-year revolving credit facility of $45.0
million. As of June 30, 2008 we had no amounts outstanding
under the revolving credit facility and $292.4 million outstanding under the
term loan facility. Obligations under the senior secured credit
facility have a floating interest rate of the London Inter-Bank Offered Rate
(“LIBOR”) plus a margin or prime rate plus a margin. Currently, the
term loan is a LIBOR loan, and the margin is 1.75%, which is adjusted quarterly
based upon the leverage ratio of the Company and its subsidiaries. In
June 2008, the Company entered into a three year fully amortizable interest rate
swap agreement (the “Swap”) with a notional amount of $150.0 million and an
expiration date of June 30, 2011. The amount outstanding under the
Swap as of June 30, 2008 was $150.0 million. Under the Swap we will
pay a fixed rate of 3.73% and receive interest at floating rates based on the
three month LIBOR rate at each quarterly re-pricing date until the expiration of
the Swap. As of June 30, 2008 the interest rate on the debt related
to the Swap was 5.5% (3.73% plus a margin of 1.75%). Our overall
effective interest rate, including the impact of the Swap, as of June 30, 2008
on our senior secured debt was 5.1%.
Our
senior secured credit facility contains certain financial covenants, including a
fixed charge coverage ratio and a leverage ratio applicable to Orthofix and our
subsidiaries on a consolidated basis. A breach of any of these
covenants could result in an event of default under the credit agreement, which
could permit acceleration of the debt payments under the facility unless such
breach is waived by the lenders, who are a party to the agreement, or the
agreement is amended. Management believes the Company was in compliance
with these financial covenants as measured at June 30, 2008.
However,
in our second quarter earnings release, has revised its operating
expectations for the remainder of 2008, in part, as a result of contract
research and development obligations which we undertook for the development of
new products. Based on the revised operating expectations, we expect
to experience difficulty meeting these financial covenants for the remainder of
2008 as measured at September 30, 2008 and December 31, 2008. If we
are unable to meet any of the financial covenants as measured at September 30,
2008 or December 31, 2008 (or any future quarterly measurement date), we intend
to seek a waiver or amendment to the credit agreement. Any requested
waivers or amendments to the credit agreement could result in fees or additional
interest charged by the lenders for their approval. Although the
Company believes we will be able to negotiate acceptable amendments or waivers,
if necessary, there can be no assurance that we will be able to do so, and
failure to do so could result in an event of default under credit agreement,
which could have a material adverse effect on our financial
position.
Each of
the domestic subsidiaries of the Company (which includes Orthofix Inc., Breg
Inc., and Blackstone) and Colgate Medical Limited and Victory Medical Limited
(wholly-owned financing subsidiaries of the Company) have guaranteed the
obligations of Orthofix Holdings under the senior secured credit
facility. The obligations of the subsidiaries under their guarantees
are secured by the pledges of their respective assets.
At June
30, 2008, we had outstanding borrowings of $8.2 million and unused available
lines of credit of approximately 2.1 million Euro ($3.3 million) under a line of
credit established in Italy to finance the working capital of our Italian
operations. The terms of the line of credit give us the option to borrow amounts
in Italy at rates determined at the time of borrowing.
We
continue to search for viable acquisition candidates that would expand our
global presence as well as add additional products appropriate for current
distribution channels. An acquisition of another company or product
line by us could result in our incurrence of additional debt and contingent
liabilities.
As
discussed in Note 18 “Subsequent Events” in the Condensed Consolidated Financial
Statements, we have entered into a collaborative agreement with Musculoskeletal
Transplant Foundation (“MTF”) to develop and commercialize a new stem cell-based
bone growth biologic matrix. Under the terms of the agreement, we
will invest up to $10.0 million in the development of the new stem cell-based
bone growth biologic matrix that will be designed to provide the beneficial
properties of an autograft in spinal and orthopedic surgeries. We
have also entered into an agreement with IIS, as mentioned above, where we have
purchased $2.5 million of intellectual property and related
technology. IIS will continue to perform research and development
functions related to the technology and under the agreement, we will pay IIS an
additional amount, up to $4.5 million for research and development performance
milestones. We believe that current cash balances together with projected cash
flows from operating activities, the available Italian line of credit, and our
debt capacity are sufficient to cover anticipated working capital and capital
expenditure needs including research and development costs and research and
development projects formerly mentioned, over the near term.
Item
3. Quantitative and Qualitative
Disclosures About Market Risk
We are
exposed to certain market risks as part of our ongoing business
operations. Primary exposures include changes in interest rates and
foreign currency fluctuations. These exposures can vary sales, cost of sales,
costs of operations, and the cost of financing and yields on cash and short-term
investments. We use derivative financial instruments, where appropriate,
to manage these risks. However, our risk management policy does not
allow us to hedge positions we do not hold nor do we enter into derivative or
other financial investments for trading or speculative purposes. As of
June 30, 2008, we had a currency swap in place to minimize foreign currency
exchange risk related to a 42.6 million Euro intercompany note foreign currency
exposure.
We are
exposed to interest rate risk in connection with our senior secured term loan
and borrowings under our revolving credit facility, which bear interest at
floating rates based on LIBOR or the prime rate plus an applicable borrowing
margin. Therefore, interest rate changes generally do not affect the fair market
value of the debt, but do impact future earnings and cash flows, assuming other
factors are held constant. We had an interest rate swap in
place as of June 30, 2008 to minimize interest rate risk related to our
LIBOR-based borrowings.
As of
June 30, 2008, we had $292.4 million of variable rate term debt represented by
borrowings under our senior secured term loan at a floating interest rate of
LIBOR plus a margin or the prime rate plus a margin, currently LIBOR plus 1.75%,
which is adjusted quarterly based upon the leverage ratio of the Company and its
subsidiaries. In June 2008, the Company entered into a Swap with a
notional amount of $150.0 million and an expiration date of June 30,
2011. The amount outstanding under the Swap as of June 30, 2008 was
$150.0 million. Under the Swap we will pay a fixed rate of 3.73% and
receive interest at floating rates based on the three month LIBOR rate at each
quarterly re-pricing date until the expiration of the Swap. As of
June 30, 2008 the interest rate on the debt related to the Swap was 5.5% (3.73%
plus a margin of 1.75%). Our overall effective interest rate,
including the impact of the Swap, as of June 30, 2008 on our senior secured debt
was 5.1%. Based on the balance outstanding under the senior secured
term loan combined with the Swap as of June 30, 2008, an immediate change of one
percentage point in the applicable interest rate on the variable rate debt would
cause an increase or decrease in interest expense of approximately
$1.4 million on an annual basis.
Our
foreign currency exposure results from fluctuating currency exchange rates,
primarily the U.S. Dollar against the Euro, Great Britain Pound, Mexican Peso
and Brazilian Real. We are subject to cost of goods currency exposure when
we produce products in foreign currencies such as the Euro or Great Britain
Pound and sell those products in U.S. Dollars. We are subject to
transactional currency exposures when foreign subsidiaries (or the Company
itself) enter into transactions denominated in a currency other than their
functional currency. As of June 30, 2008, we had an uncovered intercompany
receivable denominated in Euro for approximately $11.4 million. We
recorded a foreign currency gain during the first six months of 2008 of $0.2
million which resulted from the strengthening of the Euro against the U.S.
dollar during the period.
We also
are subject to currency exposure from translating the results of our global
operations into the U.S. dollar at exchange rates that have fluctuated from the
beginning of the period. The U.S. dollar equivalent of international
sales denominated in foreign currencies was favorably impacted during the first
six months of 2008 and 2007 by foreign currency exchange rate fluctuations with
the weakening of the U.S dollar against the local foreign currency during these
periods. The U.S. dollar equivalent of the related costs denominated
in these foreign currencies was unfavorably impacted during these
periods. As we continue to distribute and manufacture our products in
selected foreign countries, we expect that future sales and costs associated
with our activities in these markets will continue to be denominated in the
applicable foreign currencies, which could cause currency fluctuations to
materially impact our operating results.
Item
4. Controls and Procedures
Disclosure
Controls and Procedures
Under the
supervision and with the participation of our management, including our Chief
Executive Officer and our Chief Financial Officer, we performed an evaluation of
the effectiveness of the design and operation of our disclosure controls and
procedures (as defined in Exchange Act Rule 13a - 15(e) or 15d – 15 (e)) as of
the end of the period covered by this report. Based upon that evaluation,
our Chief Executive Officer and Chief Financial Officer concluded that, as of
the end of the period covered by this report, our disclosure controls and
procedures were effective.
Changes
in Internal Control over Financial Reporting
There
have not been any changes in our internal control over financial reporting
during the fiscal quarter ended June 30, 2008 that have materially affected or
are reasonably likely to materially affect, our internal control over financial
reporting.
PART
II
|
OTHER
INFORMATION
|
Item
1. Legal Proceedings
Effective
October 29, 2007, our subsidiary, Blackstone, entered into a settlement
agreement with respect to a patent infringement lawsuit captioned Medtronic
Sofamor Danek USA Inc., Warsaw Orthopedic, Inc., Medtronic Puerto Rico
Operations Co., and Medtronic Sofamor Danek Deggendorf, GmbH v. Blackstone
Medical, Inc., Civil Action No. 06-30165-MAP, filed on September 22, 2006
in the United States District Court for the District of Massachusetts. In that
lawsuit, the plaintiffs had alleged that (i) they were the exclusive licensees
of United States Patent Nos. 6,926,718 B1, 6,936,050 B2, 6,936,051 B2, 6,398,783
B1 and 7,066,961 B2 (the “Patents”), and (ii) Blackstone's making, selling,
offering for sale, and using within the United States of its Blackstone Anterior
Cervical Plate, 3º Anterior Cervical Plate, Hallmark Anterior Cervical Plate and
Construx Mini PEEK VBR System products infringed the Patents, and that such
infringement was willful. The Complaint requested both damages and an
injunction against further alleged infringement of the Patents. The Complaint
did not specifically state an amount of damages. Blackstone denied
infringement and asserted that the Patents were invalid. On July 20,
2007, we submitted a claim for indemnification from the escrow fund established
in connection with the agreement and plan of merger between the Company,
New Era Medical Corp. and Blackstone, dated as of August 4, 2006 (the
“Merger Agreement”), for any losses to us resulting from this
matter. We were subsequently notified by legal counsel for the former
shareholders that the representative of the former shareholders of Blackstone
has objected to the indemnification claim and intends to contest it in
accordance with the terms of the Merger Agreement. We are unable to
predict the outcome of the escrow claim or to estimate the amount, if any, that
may ultimately be returned to us from the escrow fund. The settlement
agreement is not expected to have a material impact on our consolidated
financial position, results of operations or cash flows.
On or
about July 23, 2007, Blackstone received a subpoena issued by the
Department of Health and Human Services, Office of Inspector General, under the
authority of the federal healthcare anti-kickback and false claims
statutes. The subpoena seeks documents for the period January 1, 2000
through July 31, 2006 which is prior to Blackstone’s acquisition by the
Company. We believe that the subpoena concerns the compensation of
physician consultants and related matters. Blackstone is cooperating
with the government’s request and is in the process of responding to the
subpoena. We are unable to predict what action, if any, might be
taken in the future by the Department of Health and Human Services, Office of
Inspector General or other governmental authorities as a result of this
investigation or what impact, if any, the outcome of this matter might have on
our consolidated financial position, results of operations, or cash flows.
On September 17, 2007, we submitted a claim for indemnification from the escrow
fund established in connection with the Merger Agreement for any losses to
us resulting from this matter. We were subsequently notified by legal
counsel for the former shareholders that the representative of the former
shareholders of Blackstone has objected to the indemnification claim and intends
to contest it in accordance with the terms of the Merger
Agreement. We are unable to predict the outcome of the escrow claim
or to estimate the amount, if any, that may ultimately be returned to us from
the escrow fund.
On or
about January 7, 2008, the Company received a federal grand jury subpoena from
the United States Attorney’s Office for the District of
Massachusetts. The subpoena seeks documents for the period January 1,
2000 through July 15, 2007 from us. We believe that the subpoena
concerns the compensation of physician consultants and related matters, and
further believe that it is associated with the Department of Health and Human
Services, Office of Inspector General’s investigation of such
matters. We are cooperating with the government’s request and are in
the process of responding to the subpoena. We are unable to predict
what action, if any, might be taken in the future by governmental authorities as
a result of this investigation or what impact, if any, the outcome of this
matter might have on our consolidated financial position, results of operations,
or cash flows. It is our intention to submit a claim for
indemnification from the escrow fund established in connection with the Merger
Agreement for any recoverable losses to us or Blackstone resulting from this
matter.
On or
about September 27, 2007, Blackstone received a federal grand jury subpoena
issued by the United States Attorney’s Office for the District of Nevada
(“USAO-Nevada”). The subpoena seeks documents for the period from January 1999
to the present. We believe that the subpoena concerns payments or gifts made by
Blackstone to certain physicians. Blackstone is cooperating with the
government’s request and is in the process of responding to the subpoena.
We are unable to predict what action, if any, might be taken in the future by
the USAO-Nevada or other governmental authorities as a result of this
investigation or what impact, if any, the outcome of this matter might have on
our consolidated financial position, results of operations, or cash flows.
It is our intention to submit a claim for indemnification from the escrow fund
established in connection with the Merger Agreement for any recoverable losses
to us or Blackstone resulting from this matter.
On
February 29, 2008, Blackstone received a Civil Investigative Demand (“CID”) from
the Massachusetts Attorney General’s Office, Public Protection and Advocacy
Bureau, Healthcare Division. We believe that the CID seeks documents
concerning Blackstone’s financial relationships with certain physicians and
related matters for the period from March 2004 through the date of issuance of
the CID. We are cooperating with the government’s request and are in
the process of responding to the CID. It is our intention to submit a
claim for indemnification from the escrow fund established in connection with
the Merger Agreement for any recoverable losses to us or Blackstone resulting
from this matter.
By order
entered on January 4, 2007, the United States District Court for the Eastern
District of Arkansas unsealed a qui tam complaint captioned Thomas v. Chan, et
al., 4:06-cv-00465-JLH, filed against Dr. Patrick Chan, Blackstone and other
defendants including another device manufacturer. A qui tam action is
a civil lawsuit brought by an individual for an alleged violation of a federal
statute, in which the U.S. Department of Justice has the right to intervene and
take over the prosecution of the lawsuit at its option. The complaint
alleges causes of action under the False Claims Act for alleged
inappropriate payments and other items of value conferred on Dr.
Chan. On December 29, 2006, the U.S. Department of Justice filed a
notice of non-intervention in the case. Plaintiff subsequently
amended the complaint to add Orthofix International N.V. as a
defendant. On January 3, 2008, Dr. Chan pled guilty to one count of
knowingly soliciting and receiving kickbacks from a medical device distributor
in a criminal matter in which neither the Company nor any of its business units
or employees were defendants. In January 2008, Dr. Chan entered into
a settlement agreement with the plaintiff and certain governmental entities in
the civil qui tam action, and on February 21, 2008, a joint stipulation of
dismissal of claims against Dr. Chan in the action was filed with the court,
which removed him as a defendant in the action. On July 11, 2008, the
court granted a motion to dismiss the Company as a defendant in the
action. Blackstone remains a defendant. The Company
believes that Blackstone has meritorious defenses to the claims alleged and we
intend to defend vigorously against this lawsuit. On September 17, 2007,
we submitted a claim for indemnification from the escrow fund established in
connection with the Merger Agreement for any losses to us resulting from
this matter. We were subsequently notified by legal counsel for the
former shareholders that the representative of the former shareholders of
Blackstone has objected to the indemnification claim and intends to contest it
in accordance with the terms of the Merger Agreement. We are unable
to predict the outcome of the escrow claim or to estimate the amount, if any,
that may ultimately be returned to us from the escrow fund.
Between
January 2007 and May 2007, Blackstone and Orthofix Inc. were named defendants,
along with other medical device manufacturers, in three civil lawsuits alleging
that Dr. Chan had performed unnecessary surgeries in three different
instances. In January 2008, we learned that Orthofix Inc. was named a
defendant, along with other medical device manufacturers, in a fourth civil
lawsuit alleging that Dr. Chan had performed unnecessary
surgeries. All four civil lawsuits have been served and are pending
in the Circuit Court of White County, Arkansas. We believe that we
have meritorious defenses to the claims alleged and we intend to defend
vigorously against these lawsuits. On September 17, 2007,
we submitted a claim for indemnification from the escrow fund established
in connection with the Merger Agreement for any losses to us resulting from
one of these four civil lawsuits. We were subsequently notified by
legal counsel for the former shareholders that the representative of the former
shareholders of Blackstone has objected to the indemnification claim and intends
to contest it in accordance with the terms of the Merger
Agreement. We are unable to predict the outcome of the escrow claim
or to estimate the amount, if any, that may ultimately be returned to us from
the escrow fund.
In
addition to the foregoing claims, we have submitted claims for indemnification
from the escrow fund established in connection with the Merger Agreement for
losses that have or may result from certain claims against Blackstone alleging
that plaintiffs and/or claimants were entitled to payments for Blackstone
stock options not reflected in Blackstone's corporate ledger at the time of
Blackstone's acquisition by the Company. To date, the representative of
the former shareholders of Blackstone have not objected
to approximately $1.5 million in claims from the escrow fund, with
certain claims remaining pending.
We cannot
predict the outcome of any proceedings or claims made against the Company or its
subsidiaries and there can be no assurance that the ultimate resolution of any
claim will not have a material adverse impact on our consolidated financial
position, results of operations, or cash flows.
In
addition to the foregoing, in the normal course of our business, the
Company is involved in various lawsuits from time to time and may be
subject to certain other contingencies.
Our
subsidiary Orthofix Holdings, Inc.'s senior secured bank credit facility
contains significant financial and operating restrictions, including financial
covenants that we may be unable to satisfy in the future.
When we
acquired Blackstone on September 22, 2006, one of our wholly-owned subsidiaries,
Orthofix Holdings, Inc. (Orthofix Holdings), entered into a senior secured bank
credit facility with a syndicate of financial institutions to finance the
transaction. Orthofix and certain of Orthofix Holdings’ direct and indirect
subsidiaries, including Orthofix Inc., Breg, and Blackstone have guaranteed the
obligations of Orthofix Holdings under the senior secured bank facility. The
senior secured bank facility provides for (1) a seven-year amortizing term loan
facility of $330.0 million for which $292.4 million was outstanding at June 30,
2008, and (2) a six-year revolving credit facility of $45.0 million
upon which we had not drawn as of June 30, 2008.
The
credit agreement contains negative covenants applicable to Orthofix and its
subsidiaries, including restrictions on indebtedness, liens, dividends and
mergers and sales of assets. The credit agreement also contains certain
financial covenants, including a fixed charge coverage ratio and a leverage
ratio applicable to Orthofix and its subsidiaries on a consolidated basis. A
breach of any of these covenants could result in an event of default under the
credit agreement, which could permit acceleration of the debt payments under the
facility. Mangement believes the Company was in compliance with these financial
covenants as measured at June 30, 2008.
However,
in its second quarter earnings release, the Company has revised its
operating expectations for the remainder of 2008, in part as a result of
contract research and development obligations which it undertook for the
development of new products. Based on the revised operating expectations, the
Company expects to experience difficulty meeting these financial covenants for
the remainder of 2008 as measured at September 30, 2008 and December 31, 2008.
If the Company is unable to meet any of the financial covenants as measured at
September 30, 2008 or December 31, 2008 (or any future quarterly measurement
date), the Company intends to seek a waiver or amendment to the credit
agreement. Any requested waivers or amendments to the credit agreement could
result in fees or additional interest charged by the lenders for their
approval. Although the Company believes we will be able to
negotiate acceptable amendments or waivers, if necessary, there can be no
assurance that we will be able to do so, and failure to do so could result in an
event of default under credit agreement, which could have a material adverse
effect on our financial position. See Part I, Item 2 - “Management’s Discussion
and Analysis of Financial Condition and Results of Operations” - “Liquidity and
Capital Resources” of this Form 10-Q.
The
senior secured bank credit facility requires mandatory prepayments that may have
an adverse effect on our operations and limit our ability to grow our
business
Further,
in addition to scheduled debt payments, the credit agreement requires us to make
mandatory prepayments with (a) the excess cash flow (as defined in the credit
agreement) of Orthofix and its subsidiaries, in an amount equal to 50% of the
excess annual cash flow beginning with the year ending December 31, 2007,
provided, however, if the leverage ratio (as defined in the credit agreement) is
less than or equal to 1.75 to 1.00, as of the end of any fiscal year, there will
be no mandatory excess cash flow prepayments, with respect to such fiscal year
(b) 100% of the net cash proceeds of any debt issuances by Orthofix or any of
its subsidiaries or 50% of the net cash proceeds of equity issuances by any such
party, excluding the exercise of stock options, provided, however, if the
leverage ratio is less than or equal to 1.75 to 1.00 at the end of the preceding
fiscal year, Orthofix Holdings shall not be required to prepay the loans with
the proceeds of any such debt or equity issuance, (c) the net cash proceeds of
asset dispositions over a minimum threshold, or (d) unless reinvested, insurance
proceeds or condemnation awards. These mandatory prepayments could limit our
ability to reinvest in our business.
Item
4. Submission of Matters to a Vote of Security
Holders
The
Annual General Meeting of Shareholders of the Company was held on June 19,
2008. The total number of common shares eligible to vote as of the
record date, April 23, 2008, was 17,088,856 and pursuant to the Company’s
Articles of Association, 8,544,428 constituted a quorum. The total
number of common shares actually voted was 15,293,378.
At the
Annual General Meeting:
|
1.
|
The
following persons were elected by a plurality of the votes cast at the
meeting as Directors of the Company for a one year term expiring at the
Annual General Meeting in 2008:
|
Name
|
|
Votes For
|
|
|
Votes Withheld
|
|
Jerry
C. Benjamin
|
|
14,499,235 |
|
|
794,143 |
|
Charles
W. Federico
|
|
13,381,904 |
|
|
1,911,474 |
|
James
F. Gero
|
|
13,695,729 |
|
|
1,697,649 |
|
Peter
J. Hewett
|
|
13,067,564 |
|
|
2,225,814 |
|
Guy
J. Jordan
|
|
13,942,046 |
|
|
1,351,332 |
|
Thomas
J. Kester
|
|
14,489,677 |
|
|
803,701 |
|
Alan
W. Milinazzo
|
|
13,694,449 |
|
|
1,598,929 |
|
Maria
Sainz
|
|
14,540,731 |
|
|
752,647 |
|
Walter
P. Von Wartburg
|
|
14,529,542 |
|
|
763,836 |
|
Kenneth
R. Weisshaar
|
|
14,633,039 |
|
|
760,339 |
|
|
2.
|
Amendment
No. 1 to the Amended and Restated 2004 Long Term Incentive Plan was
approved by a vote of 7,562,912 in favor, 6,644,943 against and 3,790
abstaining; and
|
|
3.
|
The
Orthofix International N.V. Amended and Restated Stock purchase plan was
approved by a vote of 13,778,350 in favor, 429,144 against and 4,151
abstaining; and
|
|
4.
|
The
proposal to amend Article 8.3 of the Articles of Association of the
Company were approved and ratified by a vote of 13,944,325 in favor,
1,289,908 against and 9,147 abstaining
and;
|
|
5.
|
The
audited Financial Statements and the Annual Report 2007 for the year ended
December 31, 2007 were adopted and approved by a vote of 14,850,792 in
favor, 2,931 against and 439,655 abstaining;
and
|
|
6.
|
The
selection of Ernst & Young LLP to act as independent registered
public accounting firm for the Company and its subsidiaries for the
fiscal year ending December 31, 2008 was ratified by a vote of 15,032,878
in favor, 255,322 against and 5,476
abstaining.
|
Exhibit
Number
|
|
Description
|
|
|
|
3.1
|
|
Certificate
of Incorporation of the Company (filed as an exhibit to the Company’s
annual report on Form 20-F dated June 29, 2001 and incorporated herein by
reference).
|
|
|
Articles
of Association of the Company as amended.
|
|
|
Orthofix
International N.V. Amended and Restated Stock Purchase Plan.
|
10.2
|
|
Orthofix
International N.V. Staff Share Option Plan, as amended through April 22,
2003 (filed as an exhibit to the Company’s annual report on Form 10-K for
the fiscal year ended December 31, 2007 and incorporated herein by
reference).
|
10.3
|
|
Orthofix
International N.V. Amended and Restated 2004 Long Term Incentive Plan
(filed as an exhibit to the Company’s current report on Form 8-K filed
June 26, 2007 and incorporated herein by reference).
|
10.4
|
|
Amendment
No. 1 to the Orthofix International N.V. Amended and Restated 2004
Long-Term Incentive Plan (filed as an exhibit to the Company's current
report on Form 8-K filed June 20, 2008 and incorporated herein by
reference).
|
10.5
|
|
Form
of Nonqualified Stock Option Agreement under the Orthofix International
N.V. Amended and Restated 2004 Long Term Incentive Plan (vesting over 3
years) (filed as an exhibit to the Company's current report on Form 8-K
filed June 20, 2008 and incorporated herein by reference).
|
10.6
|
|
Form
of Nonqualified Stock Option Agreement under the Orthofix International
N.V. Amended and Restated 2004 Long Term Incentive Plan (3 year cliff
vesting) (filed as an exhibit to the Company's current report on Form 8-K
filed June 20, 2008 and incorporated herein by reference).
|
10.7
|
|
Form
of Restricted Stock Grant Agreement under the Orthofix International N.V.
Amended and Restated 2004 Long Term Incentive Plan (vesting over 3 years)
(filed as an exhibit to the Company's current report on Form 8-K filed
June 20, 2008 and incorporated herein by reference).
|
10.8
|
|
Form
of Restricted Stock Grant Agreement under the Orthofix International N.V.
Amended and Restated 2004 Long Term Incentive Plan (3 year cliff vesting)
(filed as an exhibit to the Company's current report on Form 8-K filed
June 20, 2008 and incorporated herein by reference).
|
10.9
|
|
Orthofix
Deferred Compensation Plan (filed as an exhibit to the Company’s annual
report on Form 10-K for the fiscal year ended December 31, 2006, as
amended, and incorporated herein by reference).
|
10.10
|
|
Employment
Agreement, dated as of April 15, 2005, between the Company and Charles W.
Federico (filed as an exhibit to the Company’s current report on Form 8-K
filed April 18, 2005 and incorporated herein by reference).
|
10.11
|
|
Employment
Agreement, dated as of November 20, 2003, between Orthofix International
N.V. and Bradley R. Mason (filed as an exhibit to the Company’s annual
report on Form 10-K for the fiscal year ended December 31, 2003 and
incorporated herein by reference).
|
|
|
Description
of July 2008 Modifications to Employment Arrangement with Bradley R.
Mason
|
10.13
|
|
Acquisition
Agreement dated as of November 20, 2003, among Orthofix International
N.V., Trevor Acquisition, Inc., Breg, Inc. and Bradley R. Mason, as
shareholders’ representative (filed as an exhibit to the Company’s current
report on Form 8-K filed January 8, 2004 and incorporated herein by
reference).
|
10.14
|
|
Amended
and Restated Voting and Subscription Agreement dated as of December 22,
2003, among Orthofix International N.V. and the significant shareholders
of Breg, Inc. identified on the signature pages thereto (filed as an
exhibit to the Company’s current report on Form 8-K filed on January 8,
2004 and incorporated herein by reference).
|
10.15
|
|
Amendment
to Employment Agreement dated December 29, 2005 between Orthofix Inc. and
Charles W. Federico (filed as an exhibit to the Company’s current report
on Form 8-K filed December 30, 2005 and incorporated herein by
reference).
|
10.16
|
|
Form
of Indemnity Agreement (filed as an exhibit to the Company’s annual report
on Form 10-K filed December 31, 2005 and incorporated herein by
reference).
|
10.17
|
|
Settlement
Agreement dated February 23, 2006, between Intavent Orthofix Limited, a
wholly-owed subsidiary of Orthofix International N.V. and Galvin Mould
(filed as an exhibit to the Company’s annual report on Form 8-K filed on
April 17, 2006 and incorporated herein by reference).
|
10.18
|
|
Amended
and Restated Employment Agreement, dated December 6, 2007, between
Orthofix Inc. and Alan W. Milinazzo (filed as an exhibit to the Company’s
annual report on Form 10-K for the fiscal year ended December 31, 2007, as
amended, and incorporated herein by reference).
|
10.19
|
|
Amended
and Restated Employment Agreement, dated December 6, 2007,
between Orthofix Inc. and Raymond C. Kolls (filed as an exhibit to the
Company’s annual report on Form 10-K for the fiscal year ended December
31, 2007, as amended, and incorporated herein by reference).
|
10.20
|
|
Amended
and Restated Employment Agreement, dated December 6, 2007, between
Orthofix Inc. and Michael M. Finegan. (filed as an exhibit to the
Company’s annual report on Form 10-K for the fiscal year ended December
31, 2007, as amended, and incorporated herein by reference).
|
10.21
|
|
Credit
Agreement, dated as of September 22, 2006, among Orthofix Holdings, Inc.,
Orthofix International N.V., certain domestic subsidiaries of Orthofix
International N.V., Colgate Medical Limited, Victory Medical Limited,
Swiftsure Medical Limited, Orthofix UK Ltd, the several banks and other
financial institutions as may from time to time become parties thereunder,
and Wachovia Bank, National Association (filed as an exhibit to the
Company’s current report on Form 8-K filed September 27, 2006 and
incorporated herein by reference).
|
10.22
|
|
Agreement
and Plan of Merger, dated as of August 4, 2006, among Orthofix
International N.V., Orthofix Holdings, Inc., New Era Medical Limited,
Blackstone Medical, Inc. and William G. Lyons, III, as Equityholders’
Representative (filed as an exhibit to the Company's current report on
Form 8-K filed August 7, 2006 and incorporated herein by
reference).
|
10.23
|
|
Employment
Agreement, dated as of September 22, 2006, between Blackstone Medical,
Inc. and Matthew V. Lyons (filed as an exhibit to the Company’s annual
report on Form 10-K for the fiscal year ended December 31, 2006, as
amended, and incorporated herein by reference).
|
10.24
|
|
Amended
and Restated Employment Agreement dated December 6, 2007 between Orthofix
Inc. and Timothy M. Adams (filed as an exhibit to the Company’s annual
report on Form 10-K for the fiscal year ended December 31, 2007, as
amended, and incorporated herein by reference).
|
10.25
|
|
Letter
Agreement between Orthofix International N.V. and Bradley R. Mason dated
November 20, 2007 (filed as an exhibit to the Company’s current report on
Form 8-K filed November 21, 2007 and incorporated herein by
reference).
|
10.26
|
|
Amended
and Restated Performance Accelerated Stock Option Agreement between
Orthofix International N.V. and Bradley R. Mason dated November 20, 2007
(filed as an exhibit to the Company’s annual report on Form 10-K for the
fiscal year ended December 31, 2007, as amended, and incorporated herein
by reference).
|
10.27
|
|
Nonqualified
Stock Option Agreement between Timothy M. Adams and Orthofix International
N.V. dated November 19, 2007 (filed as an exhibit to the Company’s current
report on Form 8-K filed November 21, 2007 and incorporated herein by
reference).
|
10.28
|
|
Employment
Agreement between Orthofix Inc. and Oliver Burckhardt, dated as of
December 11, 2007 (filed as an exhibit to the Company’s annual report on
Form 10-K for the fiscal year ended December 31, 2007, as amended, and
incorporated herein by reference).
|
10.29
|
|
Employment
Agreement between Orthofix Inc. and Scott Dodson, dated as of December 10,
2007 (filed as an exhibit to the Company’s annual report on Form 10-K for
the fiscal year ended December 31, 2007, as amended, and incorporated
herein by reference).
|
10.30
|
|
Employment
Agreement between Orthofix Inc. and Michael Simpson, dated as of December
6, 2007 (filed as an exhibit to the Company’s annual report on Form 10-K
for the fiscal year ended December 31, 2007, as amended, and incorporated
herein by reference).
|
10.31
|
|
Description
of Director Fee Policy (filed as an exhibit to the Company’s annual report
on Form 10-K for the fiscal year ended December 31, 2007, as amended, and
incorporated herein by reference).
|
10.32
|
|
Summary
of Orthofix International N.V. Annual Incentive Program (filed as an
exhibit to the Company’s current report on Form 8-K filed April 11, 2008,
and incorporated herein by reference).
|
10.33
|
|
Employment
Agreement between Orthofix Inc. and Thomas Hein dated as of April 11, 2008
(filed as an exhibit to the Company's quarterly report on Form 10-Q for
the quarter ended March 31, 2008 and incorporated herein by
reference).
|
10.34
|
|
Nonqualified
Stock Option Agreement under the Orthofix International N.V. Amended and
Restated 2004 Long-Term Incentive Plan, dated April 11, 2008, between
Orthofix International N.V. and Thomas Hein (filed as an exhibit to the
Company's quarterly report on Form 10-Q for the quarter ended March 31,
2008 and incorporated herein by reference).
|
10.35
|
|
Summary
of Consulting Arrangement between Orthofix International N.V. and Peter
Hewett (filed as an exhibit to the Company's quarterly report on Form 10-Q
for the quarter ended March 31, 2008 and incorporated herein by
reference).
|
|
|
Employment
Agreement between Orthofix Inc. and Denise E. Pedulla dated as of June 9,
2008.
|
|
|
Rule
13a-14(a)/15d-14(a) Certification of Chief Executive Officer.
|
|
|
Rule
13a-14(a)/15d-14(a) Certification of Chief Financial Officer.
|
|
|
Section
1350 Certification of Chief Executive Officer.
|
|
|
Section
1350 Certification of Chief Financial Officer.
|
Pursuant
to the requirements of the Securities Exchange Act of 1934, the Registrant has
duly caused this report to be signed on its behalf by the undersigned, thereunto
duly authorized.
|
|
ORTHOFIX
INTERNATIONAL N.V.
|
|
|
|
|
|
|
|
|
|
|
Date: August
8, 2008
|
|
By:
|
/s/ Alan W.
Milinazzo
|
|
|
|
Name:
|
Alan
W. Milinazzo
|
|
|
|
Title:
|
Chief
Executive Officer and President
|
|
|
|
|
|
Date: August
8, 2008
|
|
By:
|
/s/ Thomas
Hein
|
|
|
|
Name:
|
Thomas
Hein
|
|
|
|
Title:
|
Chief
Financial Officer
|
43