10-Q
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q
(Mark One)
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934 |
For the quarterly period ended March 31, 2009
or
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o |
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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: 000-32883
WRIGHT MEDICAL GROUP, INC.
(Exact name of registrant as specified in its charter)
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Delaware
(State or Other Jurisdiction
of Incorporation or Organization)
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13-4088127
(IRS Employer
Identification Number) |
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5677 Airline Road
Arlington, Tennessee
(Address of Principal Executive Offices)
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38002
(Zip Code) |
(901) 867-9971
(Registrants 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. þ Yes o No
Indicate by check mark whether the registrant has submitted electronically and posted on its
corporate Web site, if any, every Interactive Data File required to be submitted and posted
pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period
that the registrant was required to submit and post such
files). o Yes o No
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of large accelerated filer, accelerated filer and smaller reporting company in Rule 12b-2 of the Exchange Act. (Check one):
Large accelerated filer þ | Accelerated filer o | Non-accelerated filer o (Do not check if a smaller reporting company) | Smaller reporting company o |
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2
of the Exchange Act). o Yes þ No
As of
April 23, 2009, there were 38,029,603 shares of common stock outstanding.
WRIGHT MEDICAL GROUP, INC.
TABLE OF CONTENTS
SAFE-HARBOR STATEMENT
This quarterly report contains forward-looking statements within the meaning of Section
27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of
1934, as amended. Forward-looking statements reflect managements current knowledge, assumptions,
beliefs, estimates, and expectations and express managements current views of future performance,
results, and trends and may be identified by their use of terms such as anticipate, believe,
could, estimate, expect, intend, may, plan, predict, project, will, and other
similar terms. Forward-looking statements are contained in the section entitled Managements
Discussion and Analysis of Financial Condition and Results of Operations and other sections of
this quarterly report. Actual results might differ materially from those described in the
forward-looking statements. Forward-looking statements are subject to a number of risks and
uncertainties, including the factors discussed in our filings with the Securities and Exchange
Commission (including those described in Item 1A of our Annual Report on Form 10-K for the year
ended December 31, 2008, and elsewhere in this report), which could cause our actual results to
materially differ from those described in the forward-looking statements. Although we believe that
the forward-looking statements are accurate, there can be no assurance that any forward-looking
statement will prove to be accurate. A forward-looking statement should not be regarded as a
representation by us that the results described therein will be achieved. Readers should not place
undue reliance on any forward-looking statement. The forward-looking statements are made as of the
date of this quarterly report, and we assume no obligation to update any forward-looking statement
after this date.
PART I FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS (unaudited).
WRIGHT MEDICAL GROUP, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except share data)
(unaudited)
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March 31, |
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December 31, |
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2009 |
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2008 |
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Assets: |
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Current assets: |
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Cash and cash equivalents |
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$ |
96,831 |
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$ |
87,865 |
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Marketable securities |
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51,694 |
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57,614 |
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Accounts receivable, net |
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104,990 |
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102,046 |
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Inventories |
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169,851 |
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176,059 |
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Prepaid expenses |
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12,357 |
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14,263 |
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Deferred income taxes |
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29,739 |
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29,874 |
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Other current assets |
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6,351 |
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8,934 |
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Total current assets |
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471,813 |
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476,655 |
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Property, plant and equipment, net |
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133,907 |
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133,651 |
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Goodwill |
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51,449 |
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49,682 |
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Intangible assets, net |
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19,936 |
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21,090 |
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Deferred income taxes |
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3,261 |
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3,034 |
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Other assets |
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7,715 |
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8,018 |
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Total assets |
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$ |
688,081 |
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$ |
692,130 |
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Liabilities and Stockholders Equity: |
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Current liabilities: |
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Accounts payable |
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$ |
15,575 |
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$ |
15,877 |
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Accrued expenses and other current liabilities |
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53,062 |
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59,247 |
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Current portion of long-term obligations |
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131 |
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125 |
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Total current liabilities |
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68,768 |
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75,249 |
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Long-term debt and capital lease obligations |
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200,138 |
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200,136 |
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Deferred income taxes |
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164 |
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166 |
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Other liabilities |
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4,860 |
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4,951 |
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Total liabilities |
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273,930 |
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280,502 |
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Commitments and contingencies (Note 10) |
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Stockholders equity: |
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Common stock, $.01 par value,
authorized: 100,000,000 shares; issued and
outstanding: 38,028,208 shares at March 31, 2009 and
38,021,961 shares at December 31, 2008. |
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372 |
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372 |
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Additional paid-in capital |
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367,239 |
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364,594 |
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Accumulated other comprehensive income |
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14,873 |
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18,312 |
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Retained earnings |
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31,667 |
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28,350 |
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Total stockholders equity |
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414,151 |
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411,628 |
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$ |
688,081 |
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$ |
692,130 |
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The accompanying notes are an integral part of these condensed consolidated financial statements.
1
WRIGHT MEDICAL GROUP, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share data)
(unaudited)
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Three Months Ended |
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March 31, |
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2009 |
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2008 |
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Net sales |
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$ |
120,912 |
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$ |
115,865 |
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Cost of sales 1 |
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38,021 |
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32,438 |
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Gross profit |
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82,891 |
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83,427 |
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Operating expenses: |
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Selling, general and administrative 1 |
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66,609 |
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66,589 |
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Research and development 1 |
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8,906 |
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7,999 |
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Amortization of intangible assets |
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1,317 |
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1,041 |
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Restructuring charges (Note 9) |
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66 |
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1,815 |
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Total operating expenses |
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76,898 |
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77,444 |
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Operating income |
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5,993 |
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5,983 |
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Interest expense (income), net |
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1,253 |
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(363 |
) |
Other income, net |
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(363 |
) |
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(1,026 |
) |
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Income before income taxes |
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5,103 |
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7,372 |
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Provision for income taxes |
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1,786 |
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3,314 |
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Net income |
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$ |
3,317 |
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$ |
4,058 |
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Net income per share (Note 7): |
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Basic |
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$ |
0.09 |
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$ |
0.11 |
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Diluted |
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$ |
0.09 |
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$ |
0.11 |
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Weighted-average number of shares outstanding-basic |
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37,229 |
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36,605 |
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Weighted-average number of shares outstanding-diluted |
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37,340 |
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37,214 |
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1 |
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These line items include the following amounts of non-cash, stock-based compensation
expense for the periods indicated: |
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Three Months Ended |
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March 31, |
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2009 |
|
2008 |
Cost of sales |
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$ |
292 |
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$ |
344 |
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Selling, general and administrative |
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2,101 |
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|
2,971 |
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Research and development |
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|
395 |
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|
249 |
|
The accompanying notes are an integral part of these condensed consolidated financial statements.
2
WRIGHT MEDICAL GROUP, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(In thousands)
(unaudited)
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Three Months Ended |
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March 31, |
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2009 |
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2008 |
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Operating activities: |
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Net income |
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$ |
3,317 |
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$ |
4,058 |
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Adjustments to reconcile net income to net cash provided by
operating activities: |
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Depreciation |
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7,877 |
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6,154 |
|
Stock-based compensation expense |
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2,788 |
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3,564 |
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Amortization of intangible assets |
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1,317 |
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|
1,041 |
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Amortization of deferred financing costs |
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|
246 |
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251 |
|
Deferred income taxes |
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|
(881 |
) |
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(1,512 |
) |
Excess tax benefit from stock-based compensation
arrangements |
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(111 |
) |
Other |
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(345 |
) |
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(64 |
) |
Changes in assets and liabilities: |
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Accounts receivable |
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(5,192 |
) |
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(11,896 |
) |
Inventories |
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5,488 |
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(13,244 |
) |
Marketable securities |
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15,535 |
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Prepaid expenses and other current assets |
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7,446 |
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(1,310 |
) |
Accounts payable |
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(190 |
) |
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2,472 |
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Accrued expenses and other liabilities |
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(6,527 |
) |
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7,827 |
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Net cash provided by operating activities |
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15,344 |
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12,765 |
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Investing activities: |
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Capital expenditures |
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(9,826 |
) |
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(9,858 |
) |
Acquisition of businesses |
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(489 |
) |
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Purchase of intangible assets |
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(282 |
) |
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(265 |
) |
Redemption of available-for-sale marketable securities |
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5,841 |
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Net cash used in investing activities |
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(4,756 |
) |
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(10,123 |
) |
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Financing activities: |
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Issuance of common stock |
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3,421 |
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Principal payments of bank and other financing |
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(32 |
) |
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(189 |
) |
Financing under factoring agreements, net |
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(62 |
) |
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(614 |
) |
Excess tax benefit from stock-based compensation arrangements |
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111 |
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Net cash (used in) provided by financing activities |
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(94 |
) |
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2,729 |
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Effect of exchange rates on cash and cash equivalents |
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(1,528 |
) |
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|
754 |
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Net increase in cash and cash equivalents |
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|
8,966 |
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|
6,125 |
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Cash and cash equivalents, beginning of period |
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87,865 |
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229,026 |
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Cash and cash equivalents, end of period |
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$ |
96,831 |
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$ |
235,151 |
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The accompanying notes are an integral part of these condensed consolidated financial statements.
3
WRIGHT MEDICAL GROUP, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
1. Summary of Significant Accounting Policies
Basis of Presentation. The unaudited condensed consolidated interim financial statements of Wright
Medical Group, Inc. have been prepared in accordance with accounting principles generally accepted
in the United States (U.S.) for interim financial information and the instructions to Quarterly
Report on Form 10-Q and Rule 10-01 of Regulation S-X. Certain information and footnote disclosures
normally included in financial statements prepared in accordance with accounting principles
generally accepted in the U.S. have been condensed or omitted pursuant to these rules and
regulations. Accordingly, these unaudited condensed consolidated interim financial statements
should be read in conjunction with our consolidated financial statements and related notes included
in our Annual Report on Form 10-K for the year ended December 31, 2008, as filed with the
Securities and Exchange Commission (SEC).
In the opinion of management, these unaudited condensed consolidated interim financial statements
reflect all adjustments necessary for a fair presentation of our interim financial results. All
such adjustments are of a normal and recurring nature. The results of operations for any interim
period are not indicative of results for the full fiscal year.
The accompanying unaudited condensed consolidated interim financial statements include our accounts
and those of our wholly-owned domestic and international subsidiaries. Intercompany accounts and
transactions have been eliminated in consolidation.
Fair Value of Financial Instruments. The carrying values of cash and cash equivalents, accounts
receivable, and accounts payable approximate the fair value of these financial instruments at March
31, 2009 and December 31, 2008 due to their short maturities or variable rates.
The fair value of our convertible senior notes was $135 million and $155 million as of March 31,
2009 and December 31, 2008, respectively.
Effective January 1, 2008, we adopted the provisions of Statement of Financial Accounting Standards
(SFAS) No. 157, Fair Value Measurements (SFAS 157), for financial assets and liabilities measured
at fair value on a recurring basis. Effective January 1, 2009, we adopted the provisions of SFAS
157 for nonfinancial assets and liabilities measured at fair value on a recurring basis. This
Statement applies to all financial and nonfinancial assets and liabilities that are being measured
and reported on a fair value basis, and establishes a framework for measuring the fair value of
assets and liabilities and expands disclosures about fair value measurements. The adoption of SFAS
157 had no impact to our condensed consolidated interim financial statements. SFAS 157 requires
fair value measurements be classified and disclosed in one of the following three categories:
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Level 1: |
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Financial instruments with unadjusted, quoted prices listed on active
market exchanges. |
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Level 2: |
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Financial instruments determined using prices for recently traded financial
instruments with similar underlying terms as well as directly or indirectly observable
inputs, such as interest rates and yield curves that are observable at commonly quoted
intervals. |
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Level 3: |
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Financial instruments that are not actively traded on a market exchange.
This category includes situations where there is little, if any, market activity for
the financial instrument. The prices are determined using significant unobservable
inputs or valuation techniques. |
As of March 31, 2009 and December 31, 2008, we had available-for-sale marketable securities
totaling $51.7 million and $57.6 million, respectively, consisting of investments in treasury
bills, government and agency bonds and certificates of deposits, all of which are valued at fair
value using a market approach. A total of $49.6 million of our available-for-sale securities is
valued based on quoted prices in active exchange markets (Level 1). The remaining $2.1 million is
valued at fair value using other observable inputs (Level 2).
4
WRIGHT MEDICAL GROUP, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
(UNAUDITED)
2. Inventories
Inventories consist of the following (in thousands):
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March 31, |
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December 31, |
|
|
|
2009 |
|
|
2008 |
|
Raw materials |
|
$ |
9,666 |
|
|
$ |
9,502 |
|
Work-in-process |
|
|
28,658 |
|
|
|
34,811 |
|
Finished goods |
|
|
131,527 |
|
|
|
131,746 |
|
|
|
|
|
|
|
|
|
|
$ |
169,851 |
|
|
$ |
176,059 |
|
|
|
|
|
|
|
|
3. Property, Plant and Equipment, Net
Property, plant and equipment consists of the following (in thousands):
|
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|
|
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|
|
|
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March 31, |
|
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December 31, |
|
|
|
2009 |
|
|
2008 |
|
Property, plant and equipment, at cost |
|
$ |
260,022 |
|
|
$ |
254,543 |
|
Less: Accumulated depreciation |
|
|
(126,115 |
) |
|
|
(120,892 |
) |
|
|
|
|
|
|
|
|
|
$ |
133,907 |
|
|
$ |
133,651 |
|
|
|
|
|
|
|
|
4. Long-Term Debt and Capital Lease Obligations
Long-term debt and capital lease obligations consist of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
December 31, |
|
|
|
2009 |
|
|
2008 |
|
Capital lease obligations |
|
$ |
269 |
|
|
$ |
261 |
|
Convertible senior notes |
|
|
200,000 |
|
|
|
200,000 |
|
|
|
|
|
|
|
|
|
|
|
200,269 |
|
|
|
200,261 |
|
Less: current portion |
|
|
(131 |
) |
|
|
(125 |
) |
|
|
|
|
|
|
|
|
|
$ |
200,138 |
|
|
$ |
200,136 |
|
|
|
|
|
|
|
|
In November 2007, we issued $200 million of Convertible Senior Notes due 2014. The notes will
mature on December 1, 2014. The notes pay interest semiannually at an annual rate of 2.625% and are
convertible into shares of our common stock at an initial conversion rate of 30.6279 shares per
$1,000 principal amount of the notes, which represents a conversion price of $32.65 per share. The
notes are unsecured obligations and are subordinated to all existing and future secured debt, our
revolving credit facility, and all liabilities of our subsidiaries.
On March 31, 2009, our revolving credit facility had availability of $100 million, which can be
increased by up to an additional $50 million at our request and subject to the agreement of the
lenders. We currently have no borrowings outstanding under the credit facility. Borrowings under
the credit facility will bear interest at the sum of a base annual rate plus an applicable annual
rate that ranges from 0% to 1.75% depending on the type of loan and our consolidated leverage
ratio, with a current annual base rate of 3.25%. The term of the credit facility extends through
June 30, 2011.
5
WRIGHT MEDICAL GROUP, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
(UNAUDITED)
5. Goodwill and Intangible Assets
Changes in the carrying amount of goodwill occurring during the three months ended March 31, 2009,
are as follows (in thousands):
|
|
|
|
|
Goodwill at December 31, 2008 |
|
$ |
49,682 |
|
Goodwill from contingent consideration associated with acquisitions |
|
|
2,149 |
|
Foreign currency translation |
|
|
(382 |
) |
|
|
|
|
Goodwill at March 31, 2009 |
|
$ |
51,449 |
|
|
|
|
|
During the first quarter ended March 31, 2009, we increased our liability for contingent
consideration by $1.4 million associated with the Inbone Technologies Inc. acquisition completed in
2008, $650,000 associated with the R&R Medical Inc. acquisition completed in 2007, $117,000
associated with the acquisition of the subtalar implant assets of Koby Ventures Ltd., d/b/a
Metasurg completed in 2007, and $12,000 associated with the A.M. Surgical Inc. acquisition
completed in 2008.
The components of our identifiable intangible assets are as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, 2009 |
|
|
December 31, 2008 |
|
|
|
|
|
|
|
Accumulated |
|
|
|
|
|
|
Accumulated |
|
|
|
Cost |
|
|
Amortization |
|
|
Cost |
|
|
Amortization |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Distribution channels |
|
$ |
20,620 |
|
|
$ |
18,928 |
|
|
$ |
21,625 |
|
|
$ |
19,316 |
|
Completed technology |
|
|
12,123 |
|
|
|
4,314 |
|
|
|
12,163 |
|
|
|
4,006 |
|
Licenses |
|
|
6,110 |
|
|
|
3,390 |
|
|
|
6,301 |
|
|
|
3,504 |
|
Customer relationships |
|
|
3,650 |
|
|
|
457 |
|
|
|
3,650 |
|
|
|
371 |
|
Trademarks |
|
|
2,733 |
|
|
|
433 |
|
|
|
2,733 |
|
|
|
373 |
|
Other |
|
|
3,624 |
|
|
|
1,402 |
|
|
|
3,360 |
|
|
|
1,172 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
48,860 |
|
|
$ |
28,924 |
|
|
|
49,832 |
|
|
$ |
28,742 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Less: Accumulated amortization |
|
|
(28,924 |
) |
|
|
|
|
|
|
(28,742 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Intangible assets, net |
|
$ |
19,936 |
|
|
|
|
|
|
$ |
21,090 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Based on the intangible assets held at March 31, 2009, we expect to amortize approximately $5.1
million for the full year of 2009, $2.3 million in 2010, $2.2 million in 2011, $2.1 million in
2012, and $1.8 million in 2013.
6. Stock-Based Compensation
Amounts recognized within the condensed consolidated financial statements for our stock-based
compensation plans are as follows:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
March 31, |
|
|
|
2009 |
|
|
2008 |
|
Total cost of share-based payment plans |
|
$ |
2,767 |
|
|
$ |
3,573 |
|
Amounts capitalized as inventory and intangible assets |
|
|
(273 |
) |
|
|
(484 |
) |
Amortization of capitalized amounts |
|
|
294 |
|
|
|
475 |
|
|
|
|
|
|
|
|
Charged against income before income taxes |
|
|
2,788 |
|
|
|
3,564 |
|
Amount of related income tax benefit |
|
|
(872 |
) |
|
|
(917 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Impact to net income |
|
$ |
1,916 |
|
|
$ |
2,647 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Impact to basic earnings per share |
|
$ |
0.05 |
|
|
$ |
0.07 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Impact to diluted earnings per share |
|
$ |
0.05 |
|
|
$ |
0.07 |
|
|
|
|
|
|
|
|
In the three-month period ended March 31, 2009, we granted approximately 37,000 non-vested shares
of common stock and 5,000 stock-settled phantom stock units at weighted-average fair values of
$17.12 and 17.53, respectively, which will be recognized on a straight line basis over the
requisite service period that, for the substantial majority of
6
WRIGHT MEDICAL GROUP, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
(UNAUDITED)
these grants, is four years. As of
March 31, 2009, we had approximately 4.0 million stock options outstanding, of
which approximately 2.6 million were exercisable, 671,000 non-vested shares of common stock
outstanding, and 115,000 stock-settled phantom stock units outstanding.
As of March 31, 2009, we had $21.5 million of total unrecognized compensation cost related to
unvested stock-based compensation arrangements granted to employees. That cost is expected to be
recognized over a weighted-average period of 2.7 years.
7. Earnings Per Share
SFAS No. 128, Earnings Per Share, requires the presentation of basic and diluted earnings per
share. Basic earnings per share is calculated based on the weighted-average shares of common stock
outstanding during the period. Diluted earnings per share is calculated to include any dilutive
effect of our common stock equivalents. Our common stock equivalents consist of stock options,
non-vested shares of common stock, stock-settled phantom stock units, and convertible debt. The
dilutive effect of the stock options, non-vested shares of common stock, and stock-settled phantom
stock units is calculated using the treasury-stock method. The dilutive effect of convertible debt
is calculated by applying the if-converted method. This assumes an add-back of interest, net of
income taxes, to net income as if the securities were converted at the beginning of the period.
During the three month periods ending March 31, 2009 and 2008, the convertible debt had an
anti-dilutive effect on earnings per share and we therefore excluded it from the diluted shares
calculation.
The weighted-average number of shares outstanding for basic and diluted earnings per share is as
follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
March 31, |
|
|
2009 |
|
2008 |
Weighted-average number of shares outstanding,
basic |
|
|
37,229 |
|
|
|
36,605 |
|
Common stock equivalents |
|
|
111 |
|
|
|
609 |
|
|
|
|
|
|
|
|
|
|
Weighted-average number of shares outstanding,
diluted |
|
|
37,340 |
|
|
|
37,214 |
|
|
|
|
|
|
|
|
|
|
The following potential common shares were excluded from the computation of diluted earnings per
share as their effect would have been anti-dilutive (in thousands):
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
March 31, |
|
|
2009 |
|
2008 |
Stock options |
|
|
3,758 |
|
|
|
2,476 |
|
Non-vested shares and stock-settled phantom stock
units |
|
|
542 |
|
|
|
86 |
|
Convertible debt |
|
|
6,126 |
|
|
|
6,126 |
|
7
WRIGHT MEDICAL GROUP, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
(UNAUDITED)
8. Other Comprehensive Income
The difference between our net income and our comprehensive (loss) income is attributable to
foreign currency translation, unrealized gains and losses on our available-for-sale marketable
securities, and adjustments related to our minimum pension liability in Japan. The following table
provides a reconciliation of net income to comprehensive (loss) income (in thousands):
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
March 31, |
|
|
|
2009 |
|
|
2008 |
|
Net income |
|
$ |
3,317 |
|
|
$ |
4,058 |
|
Changes in foreign currency translation |
|
|
(3,203 |
) |
|
|
4,129 |
|
Unrealized loss on marketable securities |
|
|
(240 |
) |
|
|
|
|
Minimum pension liability adjustment |
|
|
4 |
|
|
|
4 |
|
|
|
|
|
|
|
|
Comprehensive (loss) income |
|
$ |
(122 |
) |
|
$ |
8,191 |
|
|
|
|
|
|
|
|
9. Restructuring
In June 2007, we announced plans to close our manufacturing, distribution, and administrative
facility located in Toulon, France. The facilitys closure affected approximately 130 Toulon-based
employees. The majority of our restructuring activities were complete by the end of 2007, with
Toulons production being transferred to our existing manufacturing facility in Arlington,
Tennessee and its distribution activities being transferred to our European headquarters in
Amsterdam, the Netherlands.
Management estimates that the pre-tax restructuring charges will total approximately $28 million to
$32 million. These charges consist of the following estimates:
|
|
|
$14 million for severance and other termination benefits; |
|
|
|
|
$3 million of non-cash asset impairments of property, plant and equipment; |
|
|
|
|
$2 million of inventory write-offs and manufacturing period costs; |
|
|
|
|
$3 million to $4 million of external legal and professional fees; and |
|
|
|
|
$6 million to $9 million of other cash and non-cash charges (including employee
litigation). |
Charges associated with the restructuring are presented in the following table. All of the
following amounts were recognized within Restructuring charges in our consolidated statement of
operations, with the exception of the inventory write-offs and manufacturing period costs, which
were recognized with Cost of sales restructuring.
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Cumulative Charges as of |
(in thousands) |
|
March 31, 2009 |
|
March 31, 2009 |
|
|
|
Severance and other termination benefits |
|
$ |
|
|
|
$ |
13,593 |
|
Employee litigation accrual |
|
|
|
|
|
|
4,161 |
|
Asset impairment charges |
|
|
|
|
|
|
3,093 |
|
Inventory write-offs and manufacturing period costs |
|
|
|
|
|
|
2,139 |
|
Legal/professional fees |
|
|
58 |
|
|
|
2,427 |
|
Other |
|
|
8 |
|
|
|
231 |
|
|
|
|
Total restructuring charges |
|
$ |
66 |
|
|
$ |
25,644 |
|
|
|
|
8
WRIGHT MEDICAL GROUP, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
(UNAUDITED)
Activity in the restructuring liability for the three months ended March 31, 2009, is presented in
the following table (in thousands):
|
|
|
|
|
Balance as of December 31, 2008 |
|
$ |
4,950 |
|
|
|
|
|
|
Charges: |
|
|
|
|
Legal/professional fees |
|
|
58 |
|
Other |
|
|
8 |
|
|
|
|
|
Total accruals |
|
$ |
66 |
|
|
|
|
|
|
Payments: |
|
|
|
|
Severance and other termination benefits |
|
|
(438 |
) |
Legal/professional fees |
|
|
(131 |
) |
Other |
|
|
(8 |
) |
|
|
|
|
|
|
$ |
(577 |
) |
|
|
|
|
|
Changes in foreign currency translation |
|
|
(208 |
) |
|
|
|
|
|
|
|
|
|
Restructuring liability at March 31, 2009 |
|
$ |
4,231 |
|
|
|
|
|
In connection with the closure of our Toulon, France facility, a majority of our former employees
have filed claims to challenge the economic justification for their dismissal. Management has
accrued $3.6 million associated with these claims as of March 31, 2009. This liability is recorded
within Accrued expenses and other current liabilities in our consolidated balance sheet as of
March 31, 2009.
10. Commitments and Contingencies
In 2000, Howmedica Osteonics Corp. (Howmedica), a subsidiary of Stryker Corporation, filed a
lawsuit against us in the United States District Court for the District of New Jersey alleging that
we infringed Howmedicas U.S. Patent No. 5,824,100 related to our ADVANCE® knee product line. The lawsuit seeks an
order of infringement, injunctive relief, unspecified damages and various other costs and relief
and could impact a substantial portion of our knee product line. We believe, however, that we have
strong defenses against Howmedicas claims and are vigorously defending this lawsuit. In November
2005, the District Court issued a Markman ruling on claim construction. Howmedica conceded to the
District Court that, if the claim construction as issued was applied to our knee product line, our
products do not infringe their patent. Howmedica appealed the Markman ruling. In September 2008,
the U.S. Court of Appeals for the Federal Circuit overturned the District Courts Markman ruling on
claim construction. The case was remanded to the District Court for further proceedings on alleged
infringement and on our affirmative defenses, which include patent invalidity and unenforceability.
Management is unable to estimate the potential liability, if any, with respect to the claims and
accordingly, no provision has been made for this contingency as of March 31, 2009. These claims are
covered in part by our patent infringement insurance. Management does not believe that the outcome
of this lawsuit will have a material adverse effect on our consolidated financial position or
results of operations.
We are involved in separate disputes in Italy with a former agent and two former employees.
Management believes that we have meritorious defenses to the claims related to these disputes. The
payment of any amount related to these disputes is not probable and cannot be estimated at this
time. Accordingly, no provisions have been made for these matters as of March 31, 2009.
In December 2007, we received a subpoena from the U.S. Department of Justice (DOJ) through the U.S.
Attorney for the District of New Jersey requesting documents for the period January 1998 through
the present related to any consulting and professional service agreements with orthopaedic surgeons
in connection with hip or knee joint replacement procedures or products. This subpoena was served
shortly after several of our knee and hip competitors agreed to resolutions with the DOJ after
being subjects of investigation involving the same subject matter. We are cooperating fully with
the DOJ request. We cannot estimate what, if any, impact any results from this inquiry could have
on our consolidated results of operations or financial position.
In June 2008, we received a letter from the SEC informing us that it is conducting an informal
investigation regarding potential violations of the Foreign Corrupt Practices Act in the sale of
medical devices in a number of foreign countries by companies in the medical device industry. We
understand that several other medical device
9
WRIGHT MEDICAL GROUP, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
(UNAUDITED)
companies have received similar letters. We are
cooperating fully with the SEC request. We cannot estimate what, if any, impact any results from
this inquiry could have on our consolidated results of operations or financial position.
In late 2004 and early 2005, approximately 120 plaintiffs sued Dr. John King in the Circuit Court
of Putnam County, West Virginia. Plaintiffs allege that Dr. King was professionally negligent when
he performed surgery on the plaintiffs at Putnam General Hospital in Putnam County, West Virginia
between November 2002 and June 2003. In 33 of the lawsuits, plaintiffs alleged that Dr. King
inappropriately used a biologic product sold by us. In these lawsuits, plaintiffs named us as a
defendant and allege that our products had not been properly cleared by the United States Food and
Drug Administration, that we failed to warn that our products were not safe for their intended use,
and that we knew that Dr. King was not properly trained or was performing the surgeries
inappropriately. Plaintiffs also allege that we and two other co-defendants entered into a joint
venture with Dr. King and/or his physician assistant, David McNair, such that we could be held
liable for his/their conduct. Plaintiffs further assert claims based on strict liability, express
and implied breach of warranty, civil conspiracy and negligence. They seek damages related to
alleged lost income, medical expenses, future medical and life care expenses, damages relating to
pain and suffering and punitive and other damages.
In July 2007, a Putnam County jury found that Putnam General Hospital had negligently credentialed
Dr. King and that the hospitals conduct in credentialing Dr. King was motivated by fraud, ill
will, wantonness, oppressiveness, or by reckless or gross negligence, which allowed the plaintiffs
to seek punitive damages against the hospital. In the second quarter of 2008, the hospital, its
affiliates, and David McNair entered into confidential settlements of all claims with all but one
of the plaintiffs. EBI, LLC (a subsidiary of Biomet, Inc.), Wright, an independent contractor of
one of our distributors, and Dr. King remain as defendants in the litigation.
The first consolidated trial of six plaintiffs is scheduled to begin in the Putnam County Circuit
Court in June 2009. We have product liability insurance which may or may not cover some or all of
the ultimate resolution of this litigation. While we believe our legal and factual defenses to
these claims are strong, and will continue to vigorously defend against these claims, it is
possible that the outcome of these cases will have a material adverse effect on our consolidated
financial position or results of operations however an amount cannot be estimated.
In addition to those noted above, we are subject to various other legal proceedings, product
liability claims and other matters which arise in the ordinary course of business. In the opinion
of management, the amount of liability, if any, with respect to these matters, will not materially
affect our consolidated results of operations or financial position.
10
ITEM 2. MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.
General
The following managements discussion and analysis of financial condition and results of operations
describes the principal factors affecting the results of our operations, financial condition and
changes in financial condition for the three months ended March 31, 2009. This discussion should be
read in conjunction with the accompanying unaudited financial statements and our Annual Report on
Form 10-K for the year ended December 31, 2008, which includes additional information about our
critical accounting policies and practices and risk factors.
Executive Overview
Company Description. We are a global orthopaedic medical device company specializing in the design,
manufacture, and marketing of reconstructive joint devices and biologics products. Reconstructive
joint devices are used to replace knee, hip, and other joints that have deteriorated through
disease or injury. Biologics are used to replace damaged or diseased bone, to stimulate bone
growth, to repair damaged or diseased soft tissue, and to provide other biological solutions for
surgeons and their patients. We have been in business for over 50 years and have built a well-known
and respected brand name and strong relationships with orthopaedic surgeons.
Principal Products. We primarily sell reconstructive joint devices and biologics products. Our
reconstructive joint device sales are derived from three primary product lines: knees, hips, and
extremities. Our biologics sales encompass a broad portfolio of products designed to stimulate and
augment the natural regenerative capabilities of the human body. We also sell various orthopaedic
products not considered to be part of our knee, hip, extremity, or biologics product lines.
Significant Quarterly Business Developments. Net sales increased 4% in the first quarter of 2009 to
$120.9 million, compared to net sales of $115.9 million in the first quarter of 2008. Our net
income decreased to $3.3 million in the first quarter of 2009 from $4.1 million in the first
quarter of 2008 as a result of lower levels of interest income, increased costs associated with the
ongoing U.S. government inquiries, and the impact of lower currency exchange rates for the euro and
the British pound against the U.S. dollar, partially offset by a decrease in restructuring expenses
and non-cash, stock-based compensation.
Our first quarter domestic sales increased 11% in 2009 as a result of growth within all of our
product lines, in particular our extremity line which increased 34% compared to prior year. Our
domestic extremities growth is attributable to INBONE product sales following our
acquisition in the second quarter of 2008, the continued success of our CHARLOTTE Foot
and Ankle System, and increased sales of our DARCO® line of plating systems and our
SIDEKICK external fixation systems.
Our international sales decreased 4% to $46.6 million in the first quarter of 2009, compared to
$48.6 million in the first quarter of 2008. This decrease in the first quarter of 2009 is the
result of an unfavorable currency impact of approximately $3.3 million, which was partially offset
by growth in our Asian and Latin American markets.
Our first quarter 2009 gross profit, which declined as a percentage of sales by 3.4 points, was
negatively impacted by unfavorable foreign currency exchange rates as compared to the first quarter
of 2008, particularly the euro and the British pound. Additionally, our first quarter 2009 gross
profit included higher levels of provisions for excess and obsolete inventory and the cost of
inventories sold was higher than prior year due to increased raw material and other manufacturing
costs.
Significant Industry Factors. Our industry is impacted by numerous competitive, regulatory, and
other significant factors. The growth of our business relies on our ability to continue to develop
new products and innovative technologies, obtain regulatory clearance and compliance for our
products, protect the proprietary technology of our products and our manufacturing processes,
manufacture our products cost-effectively, respond to competitive pressures specific to each of our
geographic markets, including our ability to enforce non-compete agreements, and successfully
market and distribute our products in a profitable manner. We, and the entire industry, are subject
to extensive governmental regulation, primarily by the United States Food and Drug Administration.
Failure to comply with regulatory requirements could have a material adverse effect on our
business. Additionally, our industry is highly competitive and has recently experienced increased
pricing pressures, specifically in the areas of reconstructive joint devices. We devote significant
resources to assessing and analyzing competitive, regulatory and economic risks and opportunities.
In December 2007, we received a subpoena from the U.S. Attorneys Office for the District of New
Jersey requesting certain documents related to consulting agreements with orthopaedic surgeons.
This subpoena was served
11
shortly after several of our knee and hip competitors agreed to
resolutions with the U.S. Department of Justice (DOJ) after being subjects of investigation
involving the same subject matter. We continue to cooperate fully with the investigation by the
DOJ, and we anticipate that we will continue to incur significant expenses related to this inquiry.
In June 2008, we received a letter from the U.S. Securities and Exchange Commission (SEC) informing
us that it is conducting an informal investigation regarding potential violations of the Foreign
Corrupt Practices Act in the sale of medical devices in a number of foreign countries by companies
in the medical device industry. We understand that several other medical device companies have
received similar letters. We are cooperating fully with the SEC inquiry.
A detailed discussion of these risks and other factors is provided in Item 1A of our Annual Report
on Form 10-K for the year ended December 31, 2008, and elsewhere in this report.
Results of Operations
Comparison of three months ended March 31, 2009 to three months ended March 31, 2008
The following table sets forth, for the periods indicated, our results of operations expressed as
dollar amounts (in thousands) and as percentages of net sales:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
|
(unaudited) |
|
|
|
2009 |
|
|
2008 |
|
|
|
Amount |
|
|
% of Sales |
|
|
Amount |
|
|
% of Sales |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net sales |
|
$ |
120,912 |
|
|
|
100.0 |
% |
|
$ |
115,865 |
|
|
|
100.0 |
% |
Cost of sales 1 |
|
|
38,021 |
|
|
|
31.4 |
% |
|
|
32,438 |
|
|
|
28.0 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit |
|
|
82,891 |
|
|
|
68.6 |
% |
|
|
83,427 |
|
|
|
72.0 |
% |
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling, general and administrative 1 |
|
|
66,609 |
|
|
|
55.1 |
% |
|
|
66,589 |
|
|
|
57.5 |
% |
Research and development 1 |
|
|
8,906 |
|
|
|
7.4 |
% |
|
|
7,999 |
|
|
|
6.9 |
% |
Amortization of intangible assets |
|
|
1,317 |
|
|
|
1.1 |
% |
|
|
1,041 |
|
|
|
0.9 |
% |
Restructuring charges |
|
|
66 |
|
|
|
0.1 |
% |
|
|
1,815 |
|
|
|
1.5 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
|
76,898 |
|
|
|
63.6 |
% |
|
|
77,444 |
|
|
|
66.8 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating income |
|
|
5,993 |
|
|
|
5.0 |
% |
|
|
5,983 |
|
|
|
5.2 |
% |
Interest expense (income), net |
|
|
1,253 |
|
|
|
1.0 |
% |
|
|
(363 |
) |
|
|
(0.3 |
%) |
Other income, net |
|
|
(363 |
) |
|
|
(0.3 |
%) |
|
|
(1,026 |
) |
|
|
(0.9 |
%) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Income before income taxes |
|
|
5,103 |
|
|
|
4.2 |
% |
|
|
7,372 |
|
|
|
6.4 |
% |
Provision for income taxes |
|
|
1,786 |
|
|
|
1.5 |
% |
|
|
3,314 |
|
|
|
2.9 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
$ |
3,317 |
|
|
|
2.7 |
% |
|
$ |
4,058 |
|
|
|
3.5 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1 |
|
These line items include the following amounts of non-cash, stock-based compensation
expense, expressed in dollar amounts (in thousands) and as percentages of net sales, for
the periods indicated: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
2009 |
|
2008 |
|
|
Amount |
|
% of Sales |
|
Amount |
|
% of Sales |
Cost of sales |
|
$ |
292 |
|
|
|
0.2 |
% |
|
$ |
344 |
|
|
|
0.3 |
% |
Selling, general and administrative |
|
|
2,101 |
|
|
|
1.7 |
% |
|
|
2,971 |
|
|
|
2.6 |
% |
Research and development |
|
|
395 |
|
|
|
0.3 |
% |
|
|
249 |
|
|
|
0.2 |
% |
12
The following table sets forth our net sales by product line for the periods indicated (in
thousands) and the percentage of year-over-year change:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
|
|
|
March 31, |
|
|
|
|
|
|
2009 |
|
|
2008 |
|
|
% change |
|
Hip products |
|
$ |
41,914 |
|
|
$ |
39,900 |
|
|
|
5.0 |
% |
Knee products |
|
|
30,388 |
|
|
|
30,176 |
|
|
|
0.7 |
% |
Extremity products |
|
|
25,941 |
|
|
|
20,461 |
|
|
|
26.8 |
% |
Biologics products |
|
|
19,771 |
|
|
|
20,678 |
|
|
|
(4.4 |
%) |
Other |
|
|
2,898 |
|
|
|
4,650 |
|
|
|
(37.7 |
%) |
|
|
|
|
|
|
|
|
|
|
Total net sales |
|
$ |
120,912 |
|
|
$ |
115,865 |
|
|
|
4.4 |
% |
|
|
|
|
|
|
|
|
|
|
The following graphs illustrate our product line net sales as a percentage of total net sales for
the three months ended March 31, 2009 and 2008:
|
|
2009
|
2008 |
|
|
|
|
Net Sales. Our overall net sales growth of 4% in the first quarter of 2009 was attributable to our
continued success in our extremity product line, which increased 27% over prior year, and expansion
in our hip product line. Geographically, our domestic net sales totaled $74.4 million in the first
quarter of 2009 and $67.2 million in the first quarter of 2008, representing 61% and 58% of total
net sales, respectively, and growth of 11% in 2009 compared to 2008. Our international net sales
totaled $46.6 million in the first quarter of 2009, compared to $48.6 million in the first quarter
of 2008. International sales in 2009 include an unfavorable currency impact of $3.3 million,
principally resulting from the performance of the euro against the U.S. dollar in the first quarter
of 2009 compared to the same period of 2008. Additionally, increased sales in most of our
international markets were offset by declines in the United Kingdom, France, and Turkey.
Our hip product net sales totaled $41.9 million during the first quarter of 2009, representing an
increase of 5% over the prior year. Our domestic hip sales increased 8% over prior year, while our
international hip sales increased 3% over prior year. Our domestic growth was primarily due to
sales of revision hip stems under a distribution agreement signed during the second quarter of
2008, and increased sales of our DYNASTY® acetabular cup system. Growth in our
international markets was primarily driven by sales of our PROFEMUR® hip systems in
Japan. Our international hip sales include a $1.0 million unfavorable currency impact in 2009.
Our knee product net sales totaled $30.4 million in the first quarter of 2009 as compared to $30.2
in the same period in 2008. Year-over-year knee sales increased 2% domestically as increased unit
sales and increased pricing had a relatively even impact on our sales growth. International knee
sales decreased slightly due to an $0.8 million unfavorable currency impact.
Our extremity product net sales increased to $25.9 million in the first quarter of 2009,
representing growth of 27% over the first quarter of 2008. This year-over-year growth was driven by
sales of our INBONE products acquired
13
in the second quarter of 2008, the continued success of our
CHARLOTTE Foot and Ankle system, and increased sales of our DARCO® plating systems and
our SIDEKICK external fixation systems. Our domestic extremity product sales increased 34% in
2009, while our international extremity sales increased 3% as compared to prior year. Our
international extremity sales growth included a $0.7 million unfavorable currency impact.
Net sales of our biologics products totaled $19.8 million in the first quarter of 2009,
representing a year-over-year decline in sales of 4%. In the U.S., biologics sales increased 2% in
2009 due to increased sales of our PRO-DENSE®
injectable regenerative graft and our CANCELLO-PURE wedge products, partially offset by the
continued decline in sales of our ALLOMATRIX® line of injectable tissue-based bone graft
substitutes. Our international biologics sales decline was primarily due to decreased sales to our
stocking distributor in Turkey and the discontinuation of our biologics distribution in Belgium, as
well as an unfavorable currency impact of $0.4 million.
Cost of Sales. Our cost of sales as a percentage of net sales increased from 28.0% in the first
quarter of 2008 to 31.4% in the first quarter of 2009. This increase is primarily attributable to
higher levels of excess and obsolete inventory provisions, increased raw material and other
manufacturing costs, and unfavorable currency exchange rates compared to the first quarter of 2008.
Our cost of sales included 0.2 percentage points and 0.3 percentage points of non-cash, stock-based
compensation expense in 2009 and 2008, respectively. Our cost of sales and corresponding gross
profit percentages can be expected to fluctuate in future periods depending upon changes in our
product sales mix and prices, distribution channels and geographies, manufacturing yields, period
expenses, levels of production volume, and currency exchange rates.
Selling, General and Administrative. Our selling, general and administrative expenses as a
percentage of net sales totaled 55.1% in the first quarter of 2009, a 2.4 percentage point decrease
from 57.5% in the first quarter of 2008. Our 2009 and 2008 selling, general and administrative
expenses include $4.1 million (3.4% of net sales) and $1.7 million (1.5% of net sales),
respectively, of costs, primarily legal fees, associated with the ongoing U.S. government
inquiries. In addition, $2.1 million and $3.0 million of non-cash, stock-based compensation expense
was recognized in the first quarter of 2009 and 2008, respectively, representing 1.7% and 2.6% of
net sales in each of the years, respectively. The remaining decrease in selling, general and
administrative expenses as a percentage of sales was driven by expense savings, primarily in our
European subsidiaries, and lower levels of cash incentive compensation.
We anticipate that our selling, general and administrative expenses will increase in absolute
dollars to the extent that additional growth in net sales results in increases in sales commissions
and royalty expense associated with those sales and requires us to expand our infrastructure.
Further, in the near term, we anticipate that these expenses may increase as a percentage of net
sales as we make strategic investments in order to grow our business, as we continue to incur
expenses associated with the U.S. government inquiries, which we believe will continue to be
significant, and as our spending related to the global compliance requirements of our industry
increases.
Research and Development. Our investment in research and development activities represented
approximately 7.4% of net sales in the first quarter of 2009, as compared to 6.9% of net sales in
the first quarter of 2008. Our research and development expenses include approximately $0.4 million
(0.3% of net sales) and $0.2 million (0.2% of net sales) of non-cash, stock-based compensation
expense in the first quarter of 2009 and 2008, respectively. The increase in research and
development is primarily attributable to increased investments in product development initiatives
and clinical studies to support regulatory approvals and provide expanded proof of the efficacy of
our products.
We anticipate that our research and development expenditures may increase as a percentage of net
sales and will increase in absolute dollars as we continue to increase our investment in product
development initiatives and clinical studies to support regulatory approvals and provide expanded
proof of the efficacy of our products.
Amortization of Intangible Assets. Charges associated with the amortization of intangible assets in
the first quarter of 2009 increased to $1.3 million from $1.0 million in the first quarter of 2008.
Based on the intangible assets held at March 31, 2009, we expect to recognize amortization expense
of approximately $5.1 million for the full year of 2009, $2.3 million in 2010, $2.2 million in
2011, $2.1 million in 2012, and $1.8 million in 2013.
Interest Expense (Income), Net. Interest expense (income), net, consists of interest expense of
$1.7 million during both 2009 and 2008, primarily from borrowings under our convertible debt issued
in November 2007, our capital lease agreements, and certain of our factoring agreements, offset by
interest income of $400,000 and $2.1 million during the first quarter of 2009 and 2008,
respectively, generated by our invested cash balances and investments in marketable securities.
14
The amounts of interest income we realize in 2009 and beyond are subject to variability, dependent
upon both the rate of invested returns we realize and the amount of excess cash balances on hand.
Provision for Income Taxes. We recorded tax provisions of $1.8 million and $3.3 million in the
first quarter of 2009 and 2008, respectively. During the first quarter of 2009, our effective tax
rate was approximately 35.0%, as compared to 45.0% in the first quarter of 2008, primarily
attributable to the reinstatement of the U.S. Federal Research and Development tax credit during
the fourth quarter of 2008 and lower levels of nondeductible stock-based compensation expense
during 2009.
Seasonal Nature of Business
We traditionally experience lower sales volumes in the third quarter than throughout the rest of
the year as many of our products are used in elective procedures, which generally decline during
the summer months, typically resulting in selling, general and administrative expenses and research
and development expenses as a percentage of sales that are higher than throughout the rest of the
year. In addition, our first quarter selling, general and administrative expenses include
additional expenses that we incur in connection with the annual meeting held by the American
Academy of Orthopaedic Surgeons. This meeting, which is the largest orthopaedic meeting in the
world, features the presentation of scientific papers and instructional courses for orthopaedic
surgeons. During this 3-day event, we display our most recent and innovative products to these
surgeons.
Restructuring
In June 2007, we announced our plans to close our facilities in Toulon, France. This announcement
came after a thorough evaluation in which it was determined that we had excess manufacturing
capacity and redundant distribution and administrative resources that would be best eliminated
through the closure of this facility. The majority of our restructuring activities were complete by
the end of 2007, with Toulons production being transferred to our existing manufacturing facility
in Arlington, Tennessee and its distribution activities being transferred to our European
headquarters in Amsterdam, the Netherlands. We have estimated that total pre-tax restructuring
charges will be approximately $28 to $32 million, of which we have recognized $25.6 million through
March 31, 2009. We have seen the benefits from this restructuring within selling, general and
administrative expenses since 2008, and we anticipate seeing additional benefits within cost of
sales in 2009. See Note 9 to our condensed consolidated financial statements for further discussion
of our restructuring charges.
Liquidity and Capital Resources
The following table sets forth, for the periods indicated, certain liquidity measures (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
As of |
|
As of |
|
|
March 31, |
|
December 31, |
|
|
2009 |
|
2008 |
Cash and cash equivalents |
|
$ |
96,831 |
|
|
|
87,865 |
|
Marketable securities |
|
|
51,694 |
|
|
|
57,614 |
|
Working capital |
|
|
403,045 |
|
|
|
401,406 |
|
Line of credit availability |
|
|
100,000 |
|
|
|
100,000 |
|
Operating Activities. Cash provided by operating activities was $15.3 million for the first quarter
of 2009, as compared to $12.8 million for the first quarter of 2008. The increase in operating cash
flow is primarily attributable to changes in working capital, as favorable variances in accounts
receivable and inventory were mostly offset by unfavorable variances in accrued expenses and
marketable securities.
Investing Activities. Our capital expenditures totaled approximately $9.8 million and $9.9 million
in the first quarter of 2009 and 2008, respectively. Our industry is capital intensive,
particularly as it relates to surgical instrumentation. Historically, our capital expenditures have
consisted of purchased manufacturing equipment, research and testing equipment, computer systems,
office furniture and equipment, and surgical instruments. We expect to incur capital expenditures
of approximately $40 million in 2009 for routine capital expenditures, as well as approximately $3
million for the expansion of facilities in Arlington, Tennessee.
Financing Activities. During the first three months of 2009, cash used in financing activities
totaled $94,000 compared to the first three months of 2008, where cash provided by financing
activities totaled $2.7 million. This decrease is primarily attributable to a $3.4 million decrease
in proceeds from stock option exercises. During the first
15
quarter of 2009, we terminated our
factoring agreements. While our factoring agreements were active, the cash proceeds received from
these factoring agreements, net of the amount of factored receivables collected, were reflected as
cash flows from financing activities in our consolidated statements of cash flows.
On March 31, 2009, our revolving credit facility had availability of $100 million, which can be
increased by up to an additional $50 million at our request and subject to the agreement of the
lenders. We currently have no borrowings outstanding under the credit facility. Borrowings under
the credit facility will bear interest at the sum of a base annual rate plus an applicable annual
rate that ranges from 0% to 1.75% depending on the type of loan and our consolidated leverage
ratio, with a current annual base rate of 3.25%.
During 2007, we issued $200 million of Convertible Senior Notes due 2014, which generated net
proceeds of $193.5 million. The notes pay interest semiannually at an annual rate of 2.625%. The
notes are convertible into shares of our common stock at an initial conversion rate of 30.6279
shares per $1,000 principal amount of the notes, which represents a conversion price of $32.65 per
share. We will make scheduled interest payments in 2009 related to the notes totaling $5.3 million.
Other Liquidity Information
We have funded our cash needs since 2000 through various equity and debt issuances and through cash
flow from operations. In 2007, we issued $200 million of Convertible Senior Notes due 2014, which
generated net proceeds totaling $193.5 million.
Although it is difficult for us to predict our future liquidity requirements, we believe that our
current cash and cash equivalents balance of $96.8 million, our marketable securities balance of
$51.7 million, our existing available credit line of $100 million, and our expected cash flow from
our 2009 operations will be sufficient for the foreseeable future to fund our working capital
requirements and operations, permit anticipated capital expenditures in 2009 of approximately $43
million, and meet our contractual cash obligations in 2009.
Critical Accounting Policies and Estimates
Information on judgments related to our most critical accounting policies and estimates is
discussed in Item 7 of our Annual Report on Form 10-K for the year ended December 31, 2008. Certain
of our more critical accounting estimates require the application of significant judgment by
management in selecting the appropriate assumptions in determining the estimate. By their nature,
these judgments are subject to an inherent degree of uncertainty. We develop these judgments based
on our historical experience, terms of existing contracts, our observance of trends in the
industry, information provided by our customers, and information available from other outside
sources, as appropriate. Actual results may differ from these judgments under different assumptions
or conditions. Different, reasonable estimates could have been used for the current period.
Additionally, changes in accounting estimates are reasonably likely to occur from period to period.
Both of these factors could have a material impact on the presentation of our financial condition,
changes in financial condition or results of operations. All of our significant accounting policies
are more fully described in Note 2 to our consolidated financial statements set forth in our Annual
Report on Form 10-K for the year ended December 31, 2008. There have been no significant
modifications to the policies related to our critical accounting estimates since December 31, 2008.
16
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK.
Interest Rate Risk
Our exposure to interest rate risk arises principally from the interest rates associated with our
invested cash balances. On March 31, 2009, we had short term cash and marketable securities
investments totaling approximately $128 million. Based on this level of investment, a change of
0.25% in interest rates would have an annual impact of $321,000 on our interest income. We
currently do not hedge our exposure to interest rate fluctuations, but may do so in the future.
Foreign Currency Exchange Rate Risk
Fluctuations in the rate of exchange between the U.S. dollar and foreign currencies could adversely
affect our financial results. Approximately 28% of our total net sales were denominated in foreign
currencies both during the three months ended March 31, 2009, and for the year ended December 31,
2008, and we expect that foreign currencies will continue to represent a similarly significant
percentage of our net sales in the future. Cost of sales related to these sales are primarily
denominated in U.S. dollars; however, operating costs related to these sales are largely
denominated in the same respective currencies, thereby partially limiting our transaction risk
exposure. However, for sales not denominated in U.S. dollars, an increase in the rate at which a
foreign currency is exchanged for U.S. dollars will require more of the foreign currency to equal a
specified amount of U.S. dollars than before the rate increase. In such cases, if we price our
products in the foreign currency, we will receive less in U.S. dollars than we did before the rate
increase went into effect. If we price our products in U.S. dollars and our competitors price their
products in local currency, an increase in the relative strength of the U.S. dollar could result in
our prices not being competitive in a market where business is transacted in the local currency.
A substantial majority of our sales denominated in foreign currencies are derived from European
Union countries, which are denominated in the euro, from Japan, which are denominated in the
Japanese yen and from the United Kingdom, which are denominated in the British pound. Additionally,
we have significant intercompany receivables from our foreign subsidiaries which are denominated in
foreign currencies, principally the euro, the yen, and the British pound. Our principal exchange
rate risk, therefore, exists between the U.S. dollar and the euro, the U.S. dollar and the yen, and
the U.S. dollar and the British pound. Fluctuations from the beginning to the end of any given
reporting period result in the revaluation of our foreign currency-denominated intercompany
receivables and payables, generating currency translation gains or losses that impact our
non-operating income and expense levels in the respective period.
As discussed in Note 2 to our consolidated financial statements set forth in our Annual Report on
Form 10-K for the year ended December 31, 2008, we enter into certain short-term derivative
financial instruments in the form of foreign currency forward contracts. These forward contracts
are designed to mitigate our exposure to currency fluctuations in our intercompany balances
denominated in euros, Japanese yen, British pounds, and Canadian dollars. Any change in the fair
value of these forward contracts as a result of a fluctuation in a currency exchange rate is
expected to be offset by a change in the value of the intercompany balance. These contracts are
effectively closed at the end of each reporting period.
17
ITEM 4. CONTROLS AND PROCEDURES.
Evaluation of Disclosure Controls and Procedures
We have established disclosure controls and procedures, as such term is defined in Rule 13a-15(e)
under the Securities Exchange Act of 1934. Our disclosure controls and procedures are designed to
ensure that material information relating to us, including our consolidated subsidiaries, is made
known to our principal executive officer and principal financial officer by others within our
organization. Under the supervision and with the participation of our management, including our
principal executive officer and principal financial officer, we conducted an evaluation of the
effectiveness of our disclosure controls and procedures as of March 31, 2009. Based on this
evaluation, our principal executive officer and principal financial officer concluded that our
disclosure controls and procedures were effective as of March 31, 2009, to ensure that the
information required to be disclosed by us in the reports that we file or submit under the
Securities Exchange Act of 1934 is recorded, processed, summarized, and reported within the time
periods specified in the SECs rules and forms.
Change in Internal Control Over Financial Reporting
During the three months ended March 31, 2009, there were no significant changes in our internal
control over financial reporting that materially affected, or that are reasonably likely to
materially affect, our internal control over financial reporting.
18
PART II OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS.
Not applicable.
ITEM 1A. RISK FACTORS.
We are subject to substantial government regulation that could have a material adverse effect on
our business.
The production and marketing of our products and our ongoing research and development, pre-clinical
testing and clinical trial activities are subject to extensive regulation and review by numerous
governmental authorities both in the U.S. and abroad. See Business Government Regulation in
our Annual Report on Form 10-K for the year ended December 31, 2008, for further details on this
process. U.S. and foreign regulations govern the testing, marketing and registration of new medical
devices, in addition to regulating manufacturing practices, reporting, labeling and recordkeeping
procedures. The regulatory process requires significant time, effort and expenditures to bring our
products to market, and we cannot be assured that any of our products will be approved. Our failure
to comply with applicable regulatory requirements could result in these governmental authorities:
|
|
imposing fines and penalties on us; |
|
|
preventing us from manufacturing or selling our products; |
|
|
bringing civil or criminal charges against us; |
|
|
delaying the introduction of our new products into the market; |
|
|
recalling or seizing our products; or |
|
|
withdrawing or denying approvals or clearances for our products. |
Even if regulatory approval or clearance of a product is granted, this could result in limitations
on the uses for which the product may be labeled and promoted. Further, for a marketed product, its
manufacturer and manufacturing facilities are subject to periodic review and inspection. Subsequent
discovery of problems with a product, manufacturer or facility may result in restrictions on the
product, manufacturer or facility, including withdrawal of the product from the market or other
enforcement actions.
In April 2009, the United States Food and Drug Administration (FDA) issued an order requiring the
manufacturers of approximately 25 Class III devices to submit to the FDA a summary of any
information known or otherwise available to them concerning the safety and efficacy of the
products. Metal-on-metal hip products, including ours, are included in this order. The FDA has
historically allowed these products to be marketed without the requirement of a premarket approval
application (PMA), as they were marketed before May 28, 1976, or are substantially equivalent to
devices that were marketed before May 28, 1976, when the Medical Device Amendments of 1976 were
enacted. The FDA will determine, for each device, whether the classification of the device should
(a) remain as Class III and require submission of a PMA or a notice of completion of a Product
Development Protocol, or (b) be reclassified as Class I or II. We cannot predict the outcome of the
FDAs review of these products; however, if we are required to submit a PMA for our metal-on-metal
hip products, we may be unable to continue to market these products until the FDA approves the PMA.
We are currently conducting clinical studies of some of our products under an investigational
device exemption. Clinical studies must be conducted in compliance with FDA regulations, or the FDA
may take enforcement action. The data collected from these clinical studies will ultimately be used
to support market clearance for these products. There is no assurance that the FDA will accept the
data from these clinical studies or that it will ultimately allow market clearance for these
products.
We are subject to various federal and state laws concerning health care fraud and abuse, including
false claims laws, anti-kickback laws and physician self-referral laws. Violations of these laws
can result in criminal and/or civil punishment, including fines, imprisonment and, in the U.S.,
exclusion from participation in government health care programs. Increased funding for enforcement
of these laws and regulations has resulted in greater scrutiny of marketing practices in our
industry and resulted in several government investigations by various government authorities. If a
governmental authority were to determine that we do not comply with these laws and regulations,
then we and our officers and employees, could be subject to criminal and civil sanctions, including
exclusion from participation in federal health care reimbursement programs.
19
In order to market our product devices in the member countries of the European Union, we are
required to comply with the European Medical Devices Directive and obtain CE mark certification. CE
mark certification is the European symbol of adherence to quality assurance standards and
compliance with applicable European Medical Device Directives. Under the European Medical Devices
Directive, all medical devices including active implants must qualify for CE marking. In August
2005, a European Medical Devices Directive changed the classification of hip, knee, and shoulder
implants from class IIb to class III. The transition period for these changes began September 1,
2007. Upon reclassification to class III, manufacturers will be required to assemble significantly
more documentation and submit it to their Notified Body for formal approval prior to affixing the
CE mark to their product and packaging. We determined that 15 upclassification dossiers were
necessary to retain the CE mark certification, all of which have been submitted to the Notified
Body as of the date of this report. We have received approval for three of the upclassification
dossiers. There can be no assurance that the remaining dossiers will all be approved by the
September 2009 deadline.
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS.
Not applicable.
ITEM 3. DEFAULTS UPON SENIOR SECURITIES.
Not applicable.
ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS.
Not applicable.
ITEM 5. OTHER INFORMATION.
Not applicable.
20
ITEM 6. EXHIBITS.
(a) Exhibits
The following exhibits are filed as a part of this quarterly report on Form 10-Q or are
incorporated herein by reference:
|
|
|
Exhibit |
|
|
No. |
|
Description |
|
|
|
3.1
|
|
Fourth Amended and Restated Certificate of Incorporation of Wright Medical Group, Inc., (1) as amended by Certificate of Amendment of
Fourth Amended and Restated Certificate of Incorporation of Wright Medical Group, Inc. (2) |
|
|
|
3.2
|
|
Second Amended and Restated By-laws of Wright Medical Group, Inc. (3) |
|
|
|
4.1
|
|
Form of Common Stock certificate. (1) |
|
|
|
4.2
|
|
Indenture, dated as of November 26, 2007, between Wright Medical Group, Inc. and The Bank of New York,
as trustee (including form of 2.625% Convertible Senior Notes due 2014). (4) |
|
|
|
4.3
|
|
Underwriting Agreement, dated as of November 19, 2007, among Wright Medical Group, Inc. and J.P. Morgan
Securities Inc., Piper Jaffray & Co., and Wachovia Capital Markets, LLC. (4) |
|
|
|
10.1
|
|
Credit Agreement dated as of June 30, 2006, among Wright Medical Group, Inc., its domestic subsidiaries,
the lenders named therein, Bank of America, N.A., and SunTrust Bank.(5) as amended by First
Amendment to Credit Agreement dated as of November 16, 2007. (6) |
|
|
|
10.2
|
|
Fifth Amended and Restated 1999 Equity Incentive Plan (1999 Plan), (7) as amended by First
Amendment to 1999 Plan. (8) |
|
|
|
10.3*
|
|
Form of Incentive Stock Option Agreement, as amended by form of Amendment No. 1 to Incentive Stock
Option Agreement, pursuant to the 1999 Plan. (1) |
|
|
|
10.4*
|
|
Form of Non-Qualified Stock Option Agreement pursuant to the 1999 Plan. (1) |
|
|
|
10.5*
|
|
Form of Executive Stock Option Agreement pursuant to the 1999 Plan. (9) |
|
|
|
10.6*
|
|
Form of Non-Employee Director Stock Option Agreement pursuant to the 1999 Plan. (9) |
|
|
|
10.7*
|
|
Form of Executive Restricted Stock Grant Agreement pursuant to the 1999 Plan. (10) |
|
|
|
10.8*
|
|
Form of Non-Employee Director Restricted Stock Grant Agreement pursuant to the 1999 Plan. (10) |
|
|
|
10.9*
|
|
Form of Phantom Stock Unit Grant Agreement pursuant to the 1999 Plan. |
|
|
|
10.10*
|
|
Wright Medical Group, Inc. Executive Performance Incentive Plan. (11) |
|
|
|
10.11*
|
|
Form of Indemnification Agreement between Wright Medical Group, Inc. and its directors and executive
officers. (12) |
|
|
|
10.12*
|
|
Employment Agreement dated as of March 1, 2007, between Wright Medical Netherlands B.V. and Paul R.
Kosters. (13) |
|
|
|
10.13*
|
|
Employment Agreement dated as of April 2, 2009, between Wright Medical Technology, Inc. and Gary D.
Henley. (12) |
|
|
|
10.14*
|
|
Separation Pay Agreement dated as of April 1, 2009 between Wright Medical Technology, Inc. and John K.
Bakewell. (12) |
|
|
|
10.15*
|
|
Separation Pay Agreement dated as of April 1, 2009 between Wright Medical Technology, Inc. and Eric A.
Stookey. (12) |
|
|
|
10.16*
|
|
Separation Pay Agreement dated as of April 1, 2009 between Wright Medical Technology, Inc. and Frank S.
Bono. |
21
|
|
|
Exhibit |
|
|
No. |
|
Description |
|
|
|
11
|
|
Computation of earnings per share (included in Note 7 of the
Notes to Condensed Consolidated Financial Statements in
Financial Statements and Supplementary Data). |
|
|
|
31.1
|
|
Certification of Chief Executive Officer Pursuant to Rule
13a-14(a) Under the Securities Exchange Act of 1934. |
|
|
|
31.2
|
|
Certification of Chief Financial Officer Pursuant to Rule
13a-14(a) Under the Securities Exchange Act of 1934. |
|
|
|
32
|
|
Certification of Chief Executive Officer and Chief Financial
Officer Pursuant to Rule 13a-14(b) Under the Securities Exchange
Act of 1934 and Section 1350 of Chapter 63 of Title 18 of the
United States Code. |
|
|
|
(1) |
|
Incorporated by reference to our Registration Statement on Form S-1 (Registration No.
333-59732), as amended. |
|
(2) |
|
Incorporated by reference to our Registration Statement on Form S-8 filed on May 14, 2004. |
|
(3) |
|
Incorporated by reference to our current report on Form 8-K filed on February 19, 2008. |
|
(4) |
|
Incorporated by reference to our current report on Form 8-K filed on November 26, 2007. |
|
(5) |
|
Incorporated by reference to our current report on Form 8-K filed on July 7, 2006. |
|
(6) |
|
Incorporated by reference to our current report on Form 8-K filed on November 21, 2007. |
|
(7) |
|
Incorporated by reference to our definitive Proxy Statement filed on April 14, 2008. |
|
(8) |
|
Incorporated by reference to our quarterly report on Form 10-Q for the quarter ended September 30, 2008. |
|
(9) |
|
Incorporated by reference to our current report on Form 8-K filed on April 27, 2005. |
|
(10) |
|
Incorporated by reference to our Registration Statement on Form S-8 filed on June 18, 2008. |
|
(11) |
|
Incorporated by reference to our current report on Form 8-K filed on February 10, 2005. |
|
(12) |
|
Incorporated by reference to our current report on Form 8-K filed on April 7, 2009. |
|
(13) |
|
Incorporated by reference to our quarterly report on Form 10-Q filed on April 25, 2008. |
|
* |
|
Denotes management contract or compensatory plan or arrangement. |
22
SIGNATURES
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.
Date: April 27, 2009
|
|
|
|
|
|
WRIGHT MEDICAL GROUP, INC.
|
|
|
By: |
/s/ Gary D. Henley
|
|
|
|
Gary D. Henley |
|
|
|
President and Chief Executive Officer |
|
|
|
|
|
|
By: |
/s/ John. K. Bakewell
|
|
|
|
John K. Bakewell |
|
|
|
Executive Vice President and Chief Financial Officer (Principal
Financial Officer and Chief Accounting Officer) |
|
23
EXHIBIT INDEX
|
|
|
Exhibit |
|
|
Number |
|
DESCRIPTION |
|
|
|
10.9
|
|
Form of Phantom Stock Unit Grant Agreement pursuant to the 1999 Plan. |
|
|
|
10.16
|
|
Separation Pay Agreement dated as of April 1, 2009 between Wright
Medical Technology, Inc. and Frank S. Bono. |
|
|
|
31.1
|
|
Certification of Chief Executive Officer Pursuant to Rule 13a-14(a)
Under the Securities Exchange Act of 1934. |
|
|
|
31.2
|
|
Certification of Chief Financial Officer Pursuant to Rule 13a-14(a)
Under the Securities Exchange Act of 1934. |
|
|
|
32
|
|
Certification of Chief Executive Officer and Chief Financial Officer
Pursuant to Rule 13a-14(b) Under the Securities Exchange Act of 1934
and Section 1350 of Chapter 63 of Title 18 of the United States
Code. |