Filed by Bowne Pure Compliance
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 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 September 30, 2007
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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 NO. 0-26224
INTEGRA LIFESCIENCES HOLDINGS CORPORATION
(EXACT NAME OF REGISTRANT AS SPECIFIED IN ITS CHARTER)
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DELAWARE
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51-0317849 |
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(STATE OR OTHER JURISDICTION OF
INCORPORATION OR ORGANIZATION)
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(I.R.S. EMPLOYER
IDENTIFICATION NO.) |
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311 ENTERPRISE DRIVE |
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PLAINSBORO, NEW JERSEY
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08536 |
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(ADDRESS OF PRINCIPAL EXECUTIVE OFFICES)
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(ZIP CODE) |
REGISTRANTS TELEPHONE NUMBER, INCLUDING AREA CODE: (609) 275-0500
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 þ No o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer or
a non-accelerated filer. See definition of large accelerated filer and accelerated filer in Rule
12b-2 of the Exchange Act).
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Large accelerated filer þ
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Accelerated filer o
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Non-accelerated filer o |
Indicate by check mark whether the registrant is a shell company. Yes o No þ
The number of shares of the registrants Common Stock, $.01 par value, outstanding as of November 5, 2007 was 26,363,053.
INTEGRA LIFESCIENCES HOLDINGS CORPORATION
INDEX
2
PART I. FINANCIAL INFORMATION
Item 1. Financial Statements
INTEGRA LIFESCIENCES HOLDINGS CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(UNAUDITED)
(In thousands, except per share amounts)
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Three Months Ended |
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Nine Months Ended |
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September 30, |
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September 30, |
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2007 |
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2006 |
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2007 |
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2006 |
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TOTAL REVENUE |
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$ |
135,015 |
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$ |
116,647 |
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$ |
392,814 |
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$ |
293,903 |
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COSTS AND EXPENSES |
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Cost of product revenues |
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50,863 |
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47,559 |
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152,248 |
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116,869 |
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Research and development |
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6,546 |
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10,991 |
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18,845 |
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20,518 |
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Selling, general and administrative |
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56,241 |
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43,431 |
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160,326 |
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111,770 |
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Intangible asset amortization |
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3,029 |
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2,852 |
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9,661 |
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6,150 |
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Total costs and expenses |
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116,679 |
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104,833 |
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341,080 |
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255,307 |
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Operating income |
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18,336 |
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11,814 |
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51,734 |
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38,596 |
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Interest income |
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1,518 |
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375 |
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2,378 |
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1,993 |
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Interest expense |
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(3,863 |
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(4,362 |
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(9,896 |
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(8,117 |
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Other income (expense), net |
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(325 |
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(1,765 |
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(229 |
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(1,832 |
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Income before income taxes |
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15,666 |
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6,062 |
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43,987 |
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30,640 |
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Income tax expense |
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5,993 |
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3,468 |
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15,898 |
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11,364 |
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Net income |
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$ |
9,673 |
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$ |
2,594 |
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$ |
28,089 |
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$ |
19,276 |
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Basic net income per share |
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$ |
0.36 |
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$ |
0.09 |
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$ |
1.01 |
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$ |
0.65 |
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Diluted net income per share |
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$ |
0.33 |
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$ |
0.09 |
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$ |
0.94 |
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$ |
0.64 |
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Weighted average common shares outstanding: |
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Basic |
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27,202 |
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29,193 |
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27,909 |
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29,457 |
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Diluted |
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29,314 |
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29,867 |
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29,834 |
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30,162 |
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The accompanying notes are an integral part of these condensed consolidated financial statements.
3
INTEGRA LIFESCIENCES HOLDINGS CORPORATION
CONDENSED CONSOLIDATED BALANCE SHEETS
(UNAUDITED)
(In thousands)
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September 30, |
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December 31, |
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2007 |
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2006 |
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ASSETS |
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Current Assets: |
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Cash and cash equivalents |
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$ |
129,498 |
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$ |
22,697 |
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Accounts receivable, net of allowances of $4,806 and $4,114 |
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92,313 |
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85,018 |
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Inventories, net |
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126,371 |
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94,387 |
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Deferred tax assets |
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13,562 |
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10,010 |
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Prepaid expenses and other current assets |
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18,615 |
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9,649 |
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Total current assets |
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380,359 |
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221,761 |
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Property, plant, and equipment, net |
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55,262 |
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42,559 |
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Identifiable intangible assets, net |
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181,194 |
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179,716 |
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Goodwill |
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179,260 |
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162,414 |
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Other assets |
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14,002 |
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7,168 |
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Total assets |
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$ |
810,077 |
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$ |
613,618 |
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LIABILITIES AND STOCKHOLDERS EQUITY |
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Current Liabilities: |
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Borrowings under senior credit facility |
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$ |
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$ |
100,000 |
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Convertible securities |
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119,962 |
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119,542 |
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Accounts payable, trade |
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26,928 |
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20,329 |
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Deferred revenue |
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2,786 |
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4,319 |
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Accrued expenses and other current liabilities |
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38,509 |
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29,827 |
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Total current liabilities |
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188,185 |
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274,017 |
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Long-term convertible securities |
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330,000 |
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508 |
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Deferred tax liabilities |
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26,828 |
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31,356 |
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Long-term income taxes payable |
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8,652 |
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5,000 |
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Other liabilities |
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6,015 |
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6,575 |
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Total liabilities |
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559,680 |
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317,456 |
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Commitments and contingencies (see Note 13) |
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Stockholders Equity: |
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Common stock; $0.01 par value; 60,000 authorized shares;
32,178 and 31,464 issued at September 30, 2007 and December
31, 2006, respectively |
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322 |
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315 |
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Additional paid-in capital |
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368,544 |
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367,277 |
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Treasury stock, at cost; 5,854 and 4,147 shares at September 30, 2007 and December 31, 2006, respectively |
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(231,914 |
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(145,846 |
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Accumulated other comprehensive income (loss): |
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Foreign currency translation adjustment |
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22,724 |
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10,045 |
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Minimum pension liability adjustment, net of tax |
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(2,047 |
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(1,965 |
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Retained earnings |
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92,768 |
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66,336 |
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Total stockholders equity |
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250,397 |
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296,162 |
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Total liabilities and stockholders equity |
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$ |
810,077 |
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$ |
613,618 |
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The accompanying notes are an integral part of these condensed consolidated financial statements.
4
INTEGRA LIFESCIENCES HOLDINGS CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(UNAUDITED)
(In thousands)
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Nine Months Ended September 30, |
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2007 |
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2006 |
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OPERATING ACTIVITIES: |
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Net income |
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$ |
28,089 |
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$ |
19,276 |
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Adjustments to reconcile net income to net cash provided by operating activities: |
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Depreciation and amortization |
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19,209 |
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13,181 |
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Deferred income tax (benefit) provision |
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(5,242 |
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(7,821 |
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Amortization of bond issuance costs |
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822 |
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1,910 |
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(Gain) loss on sale of assets/investments |
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(163 |
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1,112 |
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Amortization of discount/premium on investments |
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364 |
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Share-based compensation |
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10,962 |
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10,499 |
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Excess tax benefits from stock-based compensation arrangements |
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(794 |
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(730 |
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In-process research and development |
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5,600 |
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Other, net |
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553 |
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200 |
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Changes in assets and liabilities, net of business acquisitions: |
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Accounts receivable |
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174 |
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(18,373 |
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Inventories |
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(17,321 |
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(527 |
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Prepaid expenses and other current assets |
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5,726 |
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(460 |
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Other non-current assets |
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704 |
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(114 |
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Accounts payable |
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759 |
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4,215 |
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Income taxes payable |
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(9,833 |
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(316 |
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Deferred revenue |
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(946 |
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4,776 |
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Other accrued expenses and current liabilities |
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654 |
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7,781 |
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Deferred tax liabilities |
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10,409 |
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Other non-current liabilities |
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(920 |
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(214 |
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Net cash provided by operating activities |
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32,433 |
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50,768 |
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INVESTING ACTIVITIES: |
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Cash used in business acquisition, net of cash acquired |
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(36,423 |
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(227,114 |
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Proceeds from sales/maturities of investments |
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109,872 |
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Purchases of available-for-sale investments |
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(13,074 |
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Proceeds from sale of assets |
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403 |
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Purchases of property and equipment |
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(17,245 |
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(7,236 |
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Net cash used in investing activities |
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(53,265 |
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(137,552 |
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FINANCING ACTIVITIES: |
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Borrowings under senior credit facility |
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75,000 |
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140,000 |
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Repayment of loans and credit facility |
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(175,122 |
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(54,463 |
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Proceeds from issuance of convertible notes |
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330,000 |
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Proceeds from sale of stock purchase warrants |
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21,662 |
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Purchase option hedge on convertible notes |
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(46,771 |
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Convertible note issuance and other financing costs |
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(9,830 |
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Proceeds from exercised stock options |
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16,615 |
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9,155 |
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Excess tax benefits from stock-based compensation arrangements |
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794 |
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|
730 |
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Purchases of treasury stock |
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(86,069 |
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(31,825 |
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Net cash provided by financing activities |
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126,279 |
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63,597 |
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Effect of exchange rate changes on cash and cash equivalents |
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1,354 |
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620 |
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Net change in cash and cash equivalents |
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106,801 |
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(22,567 |
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Cash and cash equivalents at beginning of period |
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22,697 |
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46,889 |
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Cash and cash equivalents at end of period |
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$ |
129,498 |
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$ |
24,322 |
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The accompanying notes are an integral part of these condensed consolidated financial statements
5
INTEGRA LIFESCIENCES HOLDINGS CORPORATION
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
1. BASIS OF PRESENTATION
General
The terms we, our, us, Company and Integra refer to Integra LifeSciences Holdings
Corporation, a Delaware corporation, and its subsidiaries unless the context suggests otherwise.
In the opinion of management, the September 30, 2007 unaudited condensed consolidated
financial statements contain all adjustments necessary for a fair statement of the financial
position, results of operations and cash flows of the Company. Certain information and footnote
disclosures normally included in financial statements prepared in accordance with generally
accepted accounting principles have been condensed or omitted in accordance with the instructions
to Form 10-Q and Rule 10-01 of Regulation S-X. These unaudited condensed consolidated financial
statements should be read in conjunction with the Companys consolidated financial statements for
the year ended December 31, 2006 included in the Companys Annual Report on Form 10-K. Operating
results for the nine-month period ended September 30, 2007 are not necessarily indicative of the
results to be expected for the entire year.
The preparation of consolidated financial statements in conformity with accounting principles
generally accepted in the United States requires management to make estimates and assumptions that
affect the reported amount of assets and liabilities, the disclosure of contingent liabilities and
the reported amounts of revenues and expenses. Significant estimates affecting amounts reported or
disclosed in the consolidated financial statements include allowances for doubtful accounts
receivable and sales returns and allowances, net realizable value of inventories, estimates of
future cash flows associated with long-lived asset valuations, depreciation and amortization
periods for long-lived assets, fair value estimates of stock-based compensation awards, valuation
allowances recorded against deferred tax assets, estimates of amounts to be paid to employees and
other exit costs to be incurred in connection with the restructuring of our operations and loss
contingencies. These estimates are based on historical experience and on various other assumptions
that are believed to be reasonable under the current circumstances. Actual results could differ
from these estimates.
Certain
reclassifications have been made to the prior-year financial statements to conform to the
current-period presentation.
During
the three and nine months ended September 30, 2007, the Company
recognized increases to net income of approximately $0.9 million
and $0.6 million, respectively, related to
prior periods. The Company deemed the amounts immaterial and, therefore, recorded such increases in
the respective current periods.
Recently Adopted Accounting Standard
Effective January 1, 2007, the Company adopted Financial Accounting Standards Board (FASB)
Interpretation No. 48 Accounting for Uncertainty in Income Taxes (FIN 48). FIN 48 specifies the
way public companies are to account for uncertainty in income tax reporting, and prescribes a
methodology for recognizing, reversing, and measuring the tax benefits of a tax position taken, or
expected to be taken, in a tax return. As a result of adopting the new standard, the Company
recorded a $2.0 million increase to reserves resulting in a cumulative effect decrease to opening
retained earnings of $1.7 million as of January 1, 2007 and an increase to goodwill of $0.3 million
for the portion associated with a tax reserve related to a recent acquisition. Including this
cumulative effect adjustment, the Company had unrecognized tax reserves of $8.1 million at
January 1, 2007, of which $1.1 million related to accrued interest and penalties. In 2007, these
unrecognized tax benefits are classified as long-term income taxes payable in the condensed
consolidated balance sheet and, if recognized, $3.3 million would affect the Companys effective
tax rate.
6
For the three months and nine months ended September 30, 2007, the Company accrued no
additional amount and $0.2 million, respectively, in unrecognized tax benefits and $0.1 and $0.3
million, respectively, of interest related to its uncertain tax positions, all of which is recorded as a component of
the Companys provision for income taxes in the condensed consolidated statement of operations. As
of September 30, 2007 the Company had unrecognized tax benefits of $8.6 million accrued in the
balance sheet.
The Company files Federal income tax returns, as well as multiple state, local and foreign
jurisdiction tax returns. The Company is no longer subject to examinations of its federal income
tax returns by the Internal Revenue Service (IRS) through fiscal 2003. All significant state and
local matters have been concluded through fiscal 2003. All significant foreign matters have been
settled through fiscal 2001. The IRS has begun an examination of the tax returns of the Companys
subsidiary in Puerto Rico for fiscal 2004 and 2005. Further, the IRS notified the Company it will
examine the U.S. consolidated Federal return for 2005. At this time the Company does not anticipate
that any material adjustments will result from this examination. Other than this matter, the
Company does not believe it is reasonably possible that its unrecognized tax benefits will
significantly change within the next twelve months.
Recently Issued Accounting Standards and Other Matters
In September 2006, FASB issued Statement of Financial Accounting Standards No. 157, Fair Value
Measurements (SFAS 157). This standard establishes a framework for measuring fair value and
expands disclosures about fair value measurement of a companys assets and liabilities. This
standard also requires that the fair value measurement should be determined based on the
assumptions that market participants would use in pricing the asset or liability. SFAS 157 is
effective for financial statements issued for fiscal years beginning after November 15, 2007 and,
generally, must be applied prospectively. The Company expects to adopt this standard beginning in
January 2008. The Company is evaluating the impact this new standard will have on its financial
position and results of operations.
In February 2007, the FASB issued Statement of Financial Accounting Standards No. 159, The
Fair Value Option for Financial Assets and Financial Liabilities (SFAS 159). The statement
provides companies an option to report certain financial assets and liabilities at fair value. The
intent of SFAS 159 is to reduce the complexity in accounting for financial instruments and the
volatility in earnings caused by measuring related assets and liabilities differently. SFAS 159 is
effective for financial statements issued for fiscal years beginning after November 15, 2007. The
Company is evaluating the impact this new standard will have on its financial position and results
of operations.
7
2. BUSINESS ACQUISITIONS
Physician Industries
On May 11, 2007, the Company acquired certain assets of the pain management business of
Physician Industries, Inc. (Physician Industries) for approximately $4.0 million in cash, subject
to certain adjustments and acquisition expenses of $74,000. In addition, the Company may pay
additional amounts over the next four years depending on the performance of the business. Physician
Industries, located in Salt Lake City, Utah, assembles, markets, and sells a comprehensive line of
pain management products for acute and chronic pain, including customized trays for spinal,
epidural, nerve block, and biopsy procedures. The Physician Industries business will be combined
with the Companys similar Spinal Specialties products line and the products will be sold under the
name Integra Pain Management.
The following summarizes the allocation of the purchase price based on the fair value of the
assets acquired and liabilities assumed (in thousands):
|
|
|
|
|
|
|
|
|
Inventory |
|
$ |
1,063 |
|
|
|
|
|
Accounts receivable |
|
|
926 |
|
|
|
|
|
Property, plant and equipment |
|
|
81 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Intangible assets: |
|
|
|
|
|
Wtd. Avg. Life |
Customer relationships |
|
|
1,191 |
|
|
10 years |
Noncompetition agreements |
|
|
100 |
|
|
5 years |
Trade name |
|
|
57 |
|
|
<1 year |
Goodwill |
|
|
1,301 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets acquired |
|
|
4,719 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts payable and other current liabilities |
|
|
621 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities assumed |
|
|
621 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net assets acquired |
|
$ |
4,098 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Management determined the preliminary fair value of assets acquired during the second quarter
2007. The purchase price allocation was finalized during the third quarter with no changes being
recorded. The goodwill recorded in connection with this acquisition is based on the benefits the
Company expects to generate from Physician Industries future cash flows.
LXU Healthcare, Inc.
On May 8, 2007, the Company acquired the shares of LXU Healthcare, Inc. (LXU) for $30.0
million in cash paid at closing and $0.5 million of acquisition-related expenses. LXU is operated
as part of the Companys surgical instruments business. We received proceeds of $0.4 million from
escrow accounts in the third quarter relating to adjustments for working capital and benefit plans,
which was accounted for as a reduction in the total purchase price. LXU, based in West Boylston,
Massachusetts, was comprised of three distinct businesses:
|
|
|
Luxtec The market-leading manufacturer of fiber optic headlight systems for the
medical industry through its Luxtec® brand. The Luxtec products are manufactured in a
31,000 square foot leased facility located in West Boylston. |
|
|
|
LXU Medical A leading specialty surgical products distributor with a sales force
calling on surgeons and key clinical decision makers, covering 18,000 operating rooms
in the southeastern, midwestern and mid-Atlantic United States. LXU Medical is the
exclusive distributor of the Luxtec fiber optic headlight systems in these territories. |
|
|
|
Bimeco A critical care products distributor with direct sales coverage in the
southeastern United States. |
8
As was the intention at the time of the acquisition, the Company is winding down the Bimeco
business, which is not aligned with the Companys strategy. The Company is integrating the LXU
Medical sales force and distributor network with the Jarit sales and distribution organization.
The following summarizes the allocation of the purchase price based on the fair value of the
assets acquired and liabilities assumed (in thousands):
|
|
|
|
|
|
|
|
|
Inventory |
|
$ |
7,700 |
|
|
|
|
|
Accounts receivable |
|
|
4,932 |
|
|
|
|
|
Cash |
|
|
1,059 |
|
|
|
|
|
Other current assets |
|
|
810 |
|
|
|
|
|
Property, plant and equipment |
|
|
1,600 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Intangible assets: |
|
|
|
|
|
Wtd. Avg. Life |
Customer relationships |
|
|
3,100 |
|
|
15 years |
Trade name (Luxtec) |
|
|
4,700 |
|
|
Indefinite |
Technology |
|
|
1,700 |
|
|
5 years |
Goodwill |
|
|
8,146 |
|
|
|
|
|
Other assets |
|
|
1,448 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets acquired |
|
|
35,195 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts payable and other current liabilities |
|
|
4,906 |
|
|
|
|
|
Other non-current liabilities |
|
|
224 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities assumed |
|
|
5,130 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net assets acquired |
|
$ |
30,065 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Management determined the preliminary fair value of assets acquired during the second quarter
2007 with the assistance of a third-party valuation firm. The purchase price allocation was
finalized during the third quarter with only minor changes recorded to goodwill. The goodwill
recorded in connection with this acquisition is based on the benefits the Company expects to
generate from LXUs future cash flows.
DenLite
On January 3, 2007, the Companys subsidiary Miltex, Inc. acquired the DenLite product line
from Welch Allyn in an asset purchase for $2.2 million in cash paid at closing and approximately
$35,000 of acquisition-related expenses. This transaction was treated as a business combination.
DenLite is a lighted mouth mirror used in dental procedures.
The following summarizes the allocation of the purchase price based on the fair value of the
assets acquired and liabilities assumed (in thousands):
|
|
|
|
|
|
|
|
|
Inventory |
|
$ |
454 |
|
|
|
|
|
Property, plant and equipment |
|
|
339 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Intangible assets: |
|
|
|
|
|
Wtd. Avg. Life |
Trade name |
|
|
642 |
|
|
20 years |
Customer relationships |
|
|
450 |
|
|
10 years |
Patents |
|
|
143 |
|
|
5 years |
Goodwill |
|
|
207 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets acquired |
|
$ |
2,235 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Management determined the preliminary fair value of assets acquired during the first quarter
2007. The purchase price allocation was finalized in the second quarter with no changes being
recorded.
9
Radionics
On March 3, 2006, the Company acquired the assets of the Radionics Division of Tyco Healthcare
Group, L.P. (Radionics) for approximately $74.5 million in cash paid at closing, subject to
certain adjustments, and $3.2 million of acquisition-related expenses in a transaction treated as a
business combination. Radionics, based in Burlington, Massachusetts, is a leader in the design,
manufacture and sale of advanced minimally invasive medical instruments in the fields of
neurosurgery and radiation therapy. Radionics products include the CUSA EXcel ultrasonic surgical
aspiration system, the CRW® stereotactic system, the XKnife® stereotactic radiosurgery system, and
the Omni Sight® EXcel image-guided surgery system.
Miltex
On May 12, 2006, the Company acquired all of the outstanding capital stock of Miltex Holdings,
Inc. (Miltex) for $102.7 million in cash paid at closing, subject to certain adjustments, and
$0.7 million of transaction-related costs. Miltex, based in York, Pennsylvania, is a leading
provider of surgical and dental hand instruments to alternate site facilities, which includes
physician and dental offices and ambulatory surgery care sectors. Miltex sells products under the
Miltex®, Meisterhand®, Vantage®, Moyco®, Union Broach®, and Thompson® trade names in over 65
countries, using a network of independent distributors. Miltex operates a manufacturing and
distribution facility in York, Pennsylvania and also operates a leased facility in Tuttlingen,
Germany, where Miltexs staff coordinates design, production and delivery of instruments.
Canada Microsurgical
On July 5, 2006, the Company acquired a direct sales force in Canada through the acquisition
of the Companys longstanding distributor; Canada Microsurgical Ltd. (Canada Microsurgical).
Canada Microsurgical has nine sales representatives. The Company paid $5.8 million (6.4 million
Canadian dollars) for Canada Microsurgical at closing and $0.1 million of transaction-related
costs. In addition, the Company paid $0.7 million (0.7 million Canadian dollars) during the third
quarter of 2007 and may pay up to an additional 1.4 million Canadian dollars over the next two
years, depending on the performance of the business.
KMI
On July 31, 2006, the Company acquired the shares of Kinetikos Medical, Inc. (KMI) for $39.5
million in cash, subject to certain adjustments, including future payments based on the performance
of the KMI business after the acquisition. No such payments were due nor made during 2006 or during
the nine months of 2007. KMI, based in Carlsbad, California, was a leading developer and
manufacturer of innovative orthopedic implants and surgical devices for small bone and joint
procedures involving the foot, ankle, hand, wrist and elbow. KMI marketed products that addressed
both the trauma and reconstructive segments of the extremities market. KMIs reconstructive
products are largely focused on treating deformities and arthritis in small joints of the upper and
lower extremity, while its trauma products are focused on the treatment of fractures of small bones
most commonly found in the extremities.
IsoTis see Note 14 Subsequent Event.
10
The following unaudited pro forma financial information summarizes the results of operations
for the three months and nine months ended September 30, 2007 and 2006 as if the acquisitions
completed by the Company during 2006 and 2007 had been completed as of the beginning of 2006. The
pro forma results are based upon certain assumptions and estimates, and they give effect to actual
operating results prior to the acquisitions and adjustments to reflect decreased interest income,
increased interest expense, depreciation expense, intangible asset amortization, and income taxes
at a rate consistent with the Companys applicable statutory rates in each year. No effect has been
given to cost reductions or operating synergies. As a result, these pro forma results do not
necessarily represent results that would have occurred if the acquisitions had taken place on the
basis assumed above, nor are they indicative of the expected results of future combined operations.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
|
September 30, |
|
|
September 30, |
|
(in thousands, except per share amounts) |
|
2007 |
|
|
2006 |
|
|
2007 |
|
|
2006 |
|
Total Revenue |
|
$ |
135,015 |
|
|
$ |
142,023 |
|
|
$ |
412,572 |
|
|
$ |
364,545 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
|
9,673 |
|
|
|
945 |
|
|
|
27,067 |
|
|
|
17,309 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income per share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
$ |
0.36 |
|
|
$ |
0.03 |
|
|
$ |
0.97 |
|
|
$ |
0.59 |
|
Diluted |
|
$ |
0.33 |
|
|
$ |
0.03 |
|
|
$ |
0.91 |
|
|
$ |
0.58 |
|
The impact of the DenLite acquisition was not material to and, therefore, not included within
the above pro forma results. The acquisition of IsoTis closed after September 30, 2007 and,
therefore, is not included within the above pro forma results.
3. INVENTORIES
Inventories, net consisted of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
December 31, |
|
|
|
2007 |
|
|
2006 |
|
Raw materials |
|
$ |
27,336 |
|
|
$ |
20,433 |
|
Work-in process |
|
|
24,352 |
|
|
|
14,416 |
|
Finished goods |
|
|
93,182 |
|
|
|
74,324 |
|
Less: reserves |
|
|
(18,499 |
) |
|
|
(14,786 |
) |
|
|
|
|
|
|
|
|
|
$ |
126,371 |
|
|
$ |
94,387 |
|
|
|
|
|
|
|
|
4. GOODWILL AND OTHER INTANGIBLE ASSETS
Changes in the carrying amount of goodwill for the nine months ended September 30, 2007, were
as follows (in thousands):
|
|
|
|
|
Balance at December 31, 2006 |
|
$ |
162,414 |
|
DenLite acquisition |
|
|
207 |
|
Miltex tax-related contingency |
|
|
1,028 |
|
Physician Industries acquisition |
|
|
1,301 |
|
LXU Healthcare acquisition |
|
|
8,146 |
|
Canada Microsurgical earnout payment |
|
|
682 |
|
Foreign currency translation |
|
|
5,482 |
|
|
|
|
|
Balance at September 30, 2007 |
|
$ |
179,260 |
|
|
|
|
|
The Companys assessment of the recoverability of goodwill is based upon a comparison of the
carrying value of goodwill with its estimated fair value, determined using a discounted cash flow
methodology. This test was performed during the second quarter and resulted in no impairment for
any of the periods presented.
11
The components of the Companys identifiable intangible assets were as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
September 30, 2007 |
|
|
December 31, 2006 |
|
|
|
Average |
|
|
|
|
|
|
Accumulated |
|
|
|
|
|
|
Accumulated |
|
|
|
Life |
|
|
Cost |
|
|
Amortization |
|
|
Cost |
|
|
Amortization |
|
Completed technology |
|
12 years |
|
$ |
36,815 |
|
|
$ |
(10,667 |
) |
|
$ |
35,632 |
|
|
$ |
(8,573 |
) |
Customer relationships |
|
12 years |
|
|
72,455 |
|
|
|
(15,424 |
) |
|
|
67,872 |
|
|
|
(10,671 |
) |
Trademarks/brand names |
|
Indefinite |
|
|
36,300 |
|
|
|
|
|
|
|
31,600 |
|
|
|
|
|
Trademarks/brand names |
|
34 years |
|
|
35,635 |
|
|
|
(4,820 |
) |
|
|
35,350 |
|
|
|
(4,029 |
) |
Noncompetition agreements |
|
5 years |
|
|
6,377 |
|
|
|
(4,150 |
) |
|
|
7,151 |
|
|
|
(4,079 |
) |
Supplier relationships |
|
30 years |
|
|
29,300 |
|
|
|
(1,351 |
) |
|
|
29,300 |
|
|
|
(620 |
) |
All other |
|
15 years |
|
|
1,531 |
|
|
|
(807 |
) |
|
|
1,620 |
|
|
|
(837 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
218,413 |
|
|
$ |
(37,219 |
) |
|
$ |
208,525 |
|
|
$ |
(28,809 |
) |
Accumulated amortization |
|
|
|
|
|
|
(37,219 |
) |
|
|
|
|
|
|
(28,809 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
181,194 |
|
|
|
|
|
|
$ |
179,716 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Annual amortization expense is expected to approximate $15.1 million in 2007, $15.1 million in
2008, $13.7 million in 2009, $11.9 million in 2010, and $11.8 million in 2011. Identifiable
intangible assets are initially recorded at fair market value at the time of acquisition generally
using an income or cost approach.
5. RESTRUCTURING ACTIVITIES
In October 2006, the Company announced plans to restructure our French sales and marketing
organization, which includes elimination of a number of positions at our Biot, France facility, and
the closing of our facility in Nantes, France. These activities have been transferred to the sales
and marketing headquarters in Lyon, France and payments should be completed in early 2008.
In connection with these restructuring activities, the Company has recorded the following
charges during the three and nine months ended September 30, 2007 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling |
|
|
|
|
|
|
Cost of |
|
|
Research and |
|
|
General and |
|
|
|
|
|
|
Sales |
|
|
Development |
|
|
Administrative |
|
|
Total |
|
Involuntary employee termination costs: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended September 30, 2007 |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
Nine months ended September 30, 2007 |
|
$ |
125 |
|
|
$ |
|
|
|
$ |
(386 |
) |
|
$ |
(261 |
) |
Below is a reconciliation of the restructuring accrual activity recorded during 2007 (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Employee |
|
|
Facility |
|
|
|
|
|
|
Termination |
|
|
Exit |
|
|
|
|
|
|
Costs |
|
|
Costs |
|
|
Total |
|
Balance at December 31, 2006 |
|
$ |
1,555 |
|
|
$ |
170 |
|
|
$ |
1,725 |
|
Additions |
|
|
298 |
|
|
|
|
|
|
|
298 |
|
Change in estimate |
|
|
(559 |
) |
|
|
|
|
|
|
(559 |
) |
Payments |
|
|
(916 |
) |
|
|
(124 |
) |
|
|
(1,040 |
) |
Acquired through acquisitions |
|
|
228 |
|
|
|
201 |
|
|
|
429 |
|
Effects of Foreign Exchange |
|
|
50 |
|
|
|
|
|
|
|
50 |
|
|
|
|
|
|
|
|
|
|
|
Balance at September 30, 2007 |
|
$ |
656 |
|
|
$ |
247 |
|
|
$ |
903 |
|
|
|
|
|
|
|
|
|
|
|
The Company expects to pay all of the remaining employee termination costs by early 2008.
12
6. DEBT
2008 Contingent Convertible Subordinated Notes
The Company pays interest on its $120 million contingent convertible subordinated notes (the
2008 Notes) at an annual rate of 2.5% each September 15 and March 15. The Company will also pay
contingent interest on the 2008 Notes if, at thirty days prior to maturity, the Companys common
stock price is greater than $37.56. The contingent interest will be payable at maturity for each of
the last three years the 2008 Notes remain outstanding in an amount equal to the greater of (1)
0.50% of the face amount of the 2008 Notes and (2) the amount of regular cash dividends paid during
each such year on the number of shares of common stock into which each 2008 Note is convertible.
Holders of the 2008 Notes may convert the 2008 Notes under certain circumstances, including when
the market price of its common stock on the previous trading day is more than $37.56 per share,
based on an initial conversion price of $34.15 per share. During the nine months ended September
30, 2007, the Companys stock price exceeded $37.56 and, therefore, the total amount outstanding
under the 2008 Notes has been classified as current. Additionally, as of September 30, 2007,
$38,000 of the 2008 Notes have been converted to common stock or cash.
The 2008 Notes are general, unsecured obligations of the Company and are subordinate to any
senior indebtedness. The Company cannot redeem the 2008 Notes prior to their maturity, and the 2008
Notes holders may compel the Company to repurchase the 2008 Notes upon a change of control. The
fair value of the Companys $120.0 million principal amount 2.5% contingent convertible
subordinated notes outstanding at September 30, 2007 was approximately $112.4 million. There are no
financial covenants associated with the convertible 2008 Notes.
2010 and 2012 Senior Convertible Notes
On June 11, 2007, the Company issued $165 million aggregate principal amount of its 2.75%
Senior Convertible Notes due 2010 (the 2010 Notes) and $165 million aggregate principal amount of
its 2.375% Senior Convertible Notes due 2012 (the 2012 Notes and together with the 2010 Notes,
the Notes). The 2010 Notes and the 2012 Notes bear interest at a rate of 2.75% per annum and
2.375% per annum, respectively, in each case payable semi-annually in arrears on December 1 and
June 1 of each year. The fair value of the 2010 Notes and the 2012 Notes at September 30, 2007 was
approximately $146.7 million and $134.7 million, respectively.
The Notes are senior, unsecured obligations of the Company, and are convertible into cash and,
if applicable, shares of its common stock based on an initial conversion rate, subject to
adjustment, of 15.0917 shares per $1,000 principal amount of notes for the 2010 Notes and 15.3935
shares per $1,000 principal amount of notes for the 2012 Notes (which represents an initial
conversion price of approximately $66.26 per share and approximately $64.96 per share for the 2010
Notes and the 2012 Notes, respectively.) The Company will satisfy any conversion of the Notes with
cash up to the principal amount of the applicable series of Notes pursuant to the net share
settlement mechanism set forth in the applicable indenture and, with respect to any excess
conversion value, with shares of the Companys common stock. The Notes are convertible only in the
following circumstances: (1) if the closing sale price of the Companys common stock exceeds 130%
of the conversion price during a period as defined in the indenture; (2) if the average trading
price per $1,000 principal amount of the Notes is less than or equal to 97% of the average
conversion value of the Notes during a period as defined in the indenture; (3) at any time on or
after December 15, 2009 (in connection with the 2010 Notes) or anytime after December 15, 2011 (in
connection with the 2012 Notes); or (4) if specified corporate transactions occur. The issue price
of the Notes was equal to their face amount, which is also the amount holders are entitled to
receive at maturity if the Notes are not converted. As of September 30, 2007, none of these
conditions existed and, as a result, the $330 million balance of the 2010 Notes and the 2012 Notes
is classified as long-term.
Holders of the Notes, who convert their notes in connection with a qualifying fundamental
change, as defined in the related indenture, may be entitled to a make-whole premium in the form of
an increase in the conversion rate. Additionally, following the occurrence of a fundamental change,
holders may require that the Company repurchase some or all of the Notes for cash at a repurchase
price equal to 100% of the principal amount of the notes being repurchased, plus accrued and unpaid
interest, if any.
13
The Notes, under the terms of the private placement agreement, are guaranteed fully by Integra
LifeSciences Corporation, a subsidiary of the Company. The 2010 Notes will rank equal in right of
payment to the 2012 Notes. The Notes will be the Companys direct senior unsecured obligations and will rank
equal in right of payment to all of the Companys existing and future unsecured and unsubordinated
indebtedness.
In connection with the issuance of the Notes, the Company entered into call transactions and
warrant transactions, primarily with affiliates of the initial purchasers of the Notes (the hedge
participants), in connection with each series of Notes. The cost of the call transactions to the
Company was approximately $46.8 million. The Company received approximately $21.7 million of
proceeds from the warrant transactions. The call transactions involve the Companys purchasing call
options from the hedge participants, and the warrant transactions involve the Companys selling
call options to the hedge participants with a higher strike price than the purchased call options.
The initial strike price of the call transactions is (1) for the 2010 Notes, approximately
$66.26 per share of Common Stock, and (2) for the 2012 Notes, approximately $64.96, in each case
subject to anti-dilution adjustments substantially similar to those in the Notes. The initial
strike price of the warrant transactions is (x) for the 2010 Notes, approximately $77.96 per share
of Common Stock and (y) for the 2012 Notes, approximately $90.95, in each case subject to customary
anti-dilution adjustments.
Senior Secured Revolving Credit Facility
The Company has a $300 million, five-year, senior secured revolving credit facility, which
it utilizes for working capital, capital expenditures, share repurchases, acquisitions and
other general corporate purposes. We had no outstanding borrowings under the credit facility as
of September 30, 2007.
We amended the credit facility in September 2007 to accommodate the acquisition of IsoTis as
well as other acquisitions. The amendment modified certain financial and negative covenants which
include the addition of up to $14.7 million of cost savings to the calculation of our Consolidated
EBITDA as well as an increase in the Total Leverage ratio from 4.0 to 4.5 to 1 through June 30,
2008.
7. STOCK-BASED COMPENSATION
As of September 30, 2007, the Company had stock options, restricted stock awards, performance
stock awards, contract stock awards and restricted stock unit awards outstanding under seven plans,
the 1993 Incentive Stock Option and Non-Qualified Stock Option Plan (the 1993 Plan), the 1996
Incentive Stock Option and Non-Qualified Stock Option Plan (the 1996 Plan), the 1998 Stock Option
Plan (the 1998 Plan), the 1999 Stock Option Plan (the 1999 Plan), the 2000 Equity Incentive
Plan (the 2000 Plan), the 2001 Equity Incentive Plan (the 2001 Plan), and the 2003 Equity
Incentive Plan (the 2003 Plan, and collectively, the Plans). No new awards may be granted under
the 1993 Plan or the 1996 Plan.
Stock options issued under the Plans become exercisable over specified periods, generally
within four years from the date of grant for officers, employees and consultants, and generally
expire six years from the grant date. The transfer and non-forfeiture provisions of restricted
stock issued under the Plans lapse over specified periods, generally three years after the date of
grant.
Stock Options
The following is a summary of stock option activity for the nine-month period ended September
30, 2007 (shares in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Wtd. Avg. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Remaining |
|
|
Aggregate |
|
|
|
Stock |
|
|
Wtd. Avg. |
|
|
Contractual |
|
|
Intrinsic |
|
|
|
Options |
|
|
Ex. Price |
|
|
Term Years |
|
|
Value |
|
Outstanding, December 31, 2006 |
|
|
3,438 |
|
|
$ |
29.41 |
|
|
|
|
|
|
|
|
|
Granted |
|
|
31 |
|
|
|
49.33 |
|
|
|
|
|
|
|
|
|
Exercised |
|
|
(601 |
) |
|
|
27.10 |
|
|
|
|
|
|
|
|
|
Cancelled |
|
|
(49 |
) |
|
|
35.11 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding, September 30, 2007 |
|
|
2,819 |
|
|
$ |
30.03 |
|
|
|
4.3 |
|
|
$41 million |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options exercisable at September 30, 2007 |
|
|
1,920 |
|
|
$ |
27.09 |
|
|
|
3.6 |
|
|
$52 million |
14
The intrinsic value of options exercised during the nine months ended September 30, 2007 and
2006 was $11.7 million and $7.7 million, respectively. The Company granted options of 31,420 shares
during the nine months ended September 30, 2007, and the weighted-average per share fair value of
stock options granted was $49.33 during the nine months ended September 30, 2007.
As of September 30, 2007, there were approximately $11.8 million of total unrecognized
compensation costs related to unvested stock options. These costs are expected to be recognized
over a weighted-average period of approximately 3.5 years.
The fair value of options granted prior to October 1, 2004 was calculated using the
Black-Scholes model, while the fair value of options granted on or after October 1, 2004 was
calculated using a binomial distribution model.
Expected volatilities are based on historical volatility of the Companys stock price with
forward-looking assumptions. The expected life of stock options is estimated based on historical
data on exercises of stock options, post-vesting forfeitures and other factors to estimate the
expected term of the stock options granted. The risk-free interest rates are derived from the U.S.
Treasury yield curve in effect on the date of grant for instruments with a remaining term similar
to the expected life of the options. In addition, the Company applies an expected forfeiture rate
when amortizing stock-based compensation expense. The estimate of the forfeiture rate is based
primarily upon historical experience of employee turnover. As individual grant awards become fully
vested, stock-based compensation expense is adjusted to recognize actual forfeitures.
The Company used the following weighted-average assumptions to calculate the fair value for
stock options granted during the following periods:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
|
September 30, |
|
|
September, |
|
|
|
2007 |
|
|
2006 |
|
|
2007 |
|
|
2006 |
|
Dividend yield |
|
|
0 |
% |
|
|
0 |
% |
|
|
0 |
% |
|
|
0 |
% |
Expected volatility |
|
|
39 |
% |
|
|
43 |
% |
|
|
39 |
% |
|
|
43 |
% |
Risk free interest |
|
|
4.3 to 5.1 |
% |
|
|
3.4 |
% |
|
|
4.3 to 5.1 |
% |
|
|
3.4 |
% |
Expected life of option from grant date |
|
6.1 years |
|
5.4 years |
|
6.1 years |
|
5.4 years |
The Company received proceeds of $16.6 million and $9.2 million from stock option exercises
for the nine months ended September 30, 2007 and 2006, respectively.
Awards of Restricted Stock, Performance Stock and Contract Stock
The following is a summary of awards of restricted stock, performance stock and contract stock
for the nine-month period ended September 30, 2007 (shares in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Performance Stock and |
|
|
|
Restricted Stock Awards |
|
|
Contract Stock Awards |
|
|
|
|
|
|
Wtd. Avg. |
|
|
|
|
|
Wtd. Avg. |
|
|
|
|
|
|
Fair Value |
|
|
|
|
|
Fair Value |
|
|
|
Shares |
|
|
Per Share |
|
|
Shares |
|
|
Per Share |
|
Unvested, December 31, 2006 |
|
|
202 |
|
|
$ |
38.08 |
|
|
|
218 |
|
|
$ |
35.40 |
|
Grants |
|
|
139 |
|
|
|
45.91 |
|
|
|
15 |
|
|
|
45.81 |
|
Vested |
|
|
(18 |
) |
|
|
35.00 |
|
|
|
|
|
|
|
|
|
Cancellations |
|
|
(33 |
) |
|
|
40.22 |
|
|
|
(10 |
) |
|
|
35.82 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unvested, September 30, 2007 |
|
|
290 |
|
|
$ |
41.90 |
|
|
|
223 |
|
|
$ |
36.10 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Performance stock awards have performance features associated with them. Performance stock,
restricted stock and contract stock awards generally have requisite service periods of three years.
The fair value of these awards is being expensed on a straight-line basis over the vesting period.
As of September 30, 2007, there were approximately $11 million of total unrecognized compensation
costs related to unvested awards. These costs are expected to be recognized over a weighted-average period of approximately 2.9 years. The
Company granted 139,045 restricted stock awards with a weighted average fair value of $46.14 during
the nine months ended September 30, 2007.
15
The Company has no formal policy related to the repurchase of shares for the purpose of
satisfying stock-based compensation obligations. Independent of these programs, the Company does
have a practice of repurchasing shares, from time to time, in the open market.
The Company also maintains an Employee Stock Purchase Plan (the ESPP), which provides
eligible employees of the Company with the opportunity to acquire shares of common stock at
periodic intervals by means of accumulated payroll deductions. The ESPP was amended in 2005 to
eliminate the look-back option and to reduce the discount available to participants to five
percent. Accordingly, the ESPP is a non-compensatory plan under Statement of Financial Accounting
Standards No. 123(R) Share-Based Payment, a Revision of FASB Statement 123 (SFAS 123(R)).
8. RETIREMENT BENEFIT PLANS
The Company maintains defined benefit pension plans that cover employees in its manufacturing
plants located in York, Pennsylvania (the Miltex Plan), Andover, United Kingdom and Tuttlingen,
Germany (the Germany Plan). The Miltex Plan is frozen and all future benefits were curtailed
prior to the acquisition of Miltex by the Company. The Company closed the Tuttlingen, Germany plant
in December, 2005. However, the Germany Plan was not terminated, and the Company remains obligated
for the accrued benefits related to this plan. The plans cover certain current and former
employees. The plans are no longer open to new participants.
Net periodic benefit costs for the Companys defined benefit pension plans included the
following amounts (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
|
September 30, |
|
|
September 30, |
|
|
|
2007 |
|
|
2006 |
|
|
2007 |
|
|
2006 |
|
Service cost |
|
$ |
33 |
|
|
$ |
53 |
|
|
$ |
135 |
|
|
$ |
157 |
|
Interest cost |
|
|
126 |
|
|
|
142 |
|
|
|
520 |
|
|
|
424 |
|
Expected return on plan assets |
|
|
(109 |
) |
|
|
(124 |
) |
|
|
(449 |
) |
|
|
(370 |
) |
Recognized net actuarial loss |
|
|
54 |
|
|
|
54 |
|
|
|
223 |
|
|
|
162 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net periodic benefit cost |
|
$ |
104 |
|
|
$ |
125 |
|
|
$ |
429 |
|
|
$ |
373 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The Company made $473,000 and $126,000 of contributions to its defined benefit pension plans
for the nine months ended September 30, 2007 and 2006, respectively.
9. TREASURY STOCK
In October 2006, the Companys Board of Directors authorized the Company to repurchase shares
of its common stock for an aggregate purchase price not to exceed $75 million through December 31,
2007 and terminated its prior repurchase program. The Company purchased 264,000 shares of its
common stock for $11.1 million during the first three months of 2007 under this program. On May
17, 2007, the Companys Board of Directors terminated the repurchase authorization it adopted in
October 2006 and authorized the Company to repurchase shares of its common stock for an aggregate
purchase price not to exceed $75 million through December 31, 2007. The Company did not repurchase
any shares of its common stock under this program. On October 30, 2007, the Companys Board of
Directors terminated the repurchase authorization it adopted on May 17, 2007 and authorized the
company to repurchase shares of its common stock for an aggregate purchase price not to exceed $75
million through December 31, 2008. Shares may be purchased either in the open market or in
privately negotiated transactions. As of September 30, 2007, there remained $75 million available
for share repurchases under this authorization. The Company did not purchase any shares of its
common stock under this repurchase program during the three months ended September 30, 2007.
16
On May 2, 2007, the Companys Board of Directors authorized a one-time repurchase of shares of
its common stock, in connection with the Notes offering that closed in June 2007, for an aggregate
purchase price not to exceed $150 million. Under this authorization, the Company repurchased
1,443,000 outstanding shares in privately negotiated transactions at the closing price of the
common stock on June 5, 2007 of $51.97 for approximately $75 million.
10. COMPREHENSIVE INCOME
Comprehensive income was as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
|
September 30, |
|
|
September 30, |
|
|
|
2007 |
|
|
2006 |
|
|
2007 |
|
|
2006 |
|
Net income |
|
$ |
9,673 |
|
|
$ |
2,594 |
|
|
$ |
28,089 |
|
|
$ |
19,276 |
|
Foreign currency translation adjustment |
|
|
8,393 |
|
|
|
1,312 |
|
|
|
12,597 |
|
|
|
7,310 |
|
Unrealized holding gains on
available-for-sale securities, net of
tax |
|
|
|
|
|
|
522 |
|
|
|
|
|
|
|
784 |
|
Reclassification adjustment for gains
(losses) included in net income, net
of tax |
|
|
|
|
|
|
(237 |
) |
|
|
|
|
|
|
17 |
|
Minimum pension liability adjustment,
net of tax |
|
|
|
|
|
|
(55 |
) |
|
|
|
|
|
|
(149 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive income |
|
$ |
18,066 |
|
|
$ |
4,136 |
|
|
$ |
40,686 |
|
|
$ |
27,238 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
11. NET INCOME PER SHARE
Basic and diluted net income per share was as follows (in thousands, except per share
amounts):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
|
September 30, |
|
|
September 30, |
|
|
|
2007 |
|
|
2006 |
|
|
2007 |
|
|
2006 |
|
Basic net income per share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
$ |
9,673 |
|
|
$ |
2,594 |
|
|
$ |
28,089 |
|
|
$ |
19,276 |
|
Weighted average common shares outstanding |
|
|
27,202 |
|
|
|
29,193 |
|
|
|
27,909 |
|
|
|
29,457 |
|
Basic net income per share |
|
$ |
0.36 |
|
|
$ |
0.09 |
|
|
$ |
1.01 |
|
|
$ |
0.65 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted net income per share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
$ |
9,673 |
|
|
$ |
2,594 |
|
|
$ |
28,089 |
|
|
$ |
19,276 |
|
Add back: Interest expense and other income/(expense)
related to convertible notes payable, net of tax |
|
|
3 |
|
|
|
|
|
|
|
8 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income available to common stock |
|
$ |
9,676 |
|
|
$ |
2,594 |
|
|
$ |
28,097 |
|
|
$ |
19,276 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average common shares outstanding Basic |
|
|
27,202 |
|
|
|
29,193 |
|
|
|
27,909 |
|
|
|
29,457 |
|
Effect of dilutive securities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock options and restricted stock |
|
|
1,027 |
|
|
|
674 |
|
|
|
959 |
|
|
|
705 |
|
Shares issuable upon conversion of notes payable |
|
|
1,085 |
|
|
|
|
|
|
|
966 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average common shares for diluted earnings per
share |
|
|
29,314 |
|
|
|
29,867 |
|
|
|
29,834 |
|
|
|
30,162 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted net income per share |
|
$ |
0.33 |
|
|
$ |
0.09 |
|
|
$ |
0.94 |
|
|
$ |
0.64 |
|
Options outstanding at September 30, 2007 and 2006 to acquire approximately 0.2 million shares
and 1.8 million shares of common stock, respectively, were excluded from the computation of diluted
net income per share for the three months ended September 30, 2007 and 2006, respectively, because
their effects would be anti-dilutive. Options outstanding at September 30, 2007 and 2006 to acquire
approximately 0.5 million shares and 1.9 million shares of common stock, respectively, were
excluded from the computation of diluted net income per share for the nine months ended September
30, 2007 and 2006, respectively, because their effects would be anti-dilutive. The Company
excluded from the computation of diluted earnings per share for the three months and nine months
ended September 30, 2006 approximately 3.5 million shares issuable upon conversion of its 2008
convertible notes payable because their effects would be anti-dilutive.
17
12. SEGMENT AND GEOGRAPHIC INFORMATION
The Companys management reviews financial results and manages the business on an aggregate
basis. Therefore, financial results are reported in a single operating segment, the development,
manufacture and marketing of medical devices for use in cranial and spinal procedures, peripheral
nerve repair, small bone and joint injuries, and the repair and reconstruction of soft tissue.
The Company presents its revenues in two categories: Neurosurgical and Orthopedic Implants and
Medical Surgical Equipment. The Companys revenues were as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
|
September 30, |
|
|
September 30, |
|
|
|
2007 |
|
|
2006 |
|
|
2007 |
|
|
2006 |
|
Revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Medical Surgical Equipment and other |
|
$ |
85,873 |
|
|
$ |
73,511 |
|
|
$ |
247,177 |
|
|
$ |
175,125 |
|
Neurosurgical and Orthopedic Implants |
|
|
49,142 |
|
|
|
43,136 |
|
|
|
145,637 |
|
|
|
118,778 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Revenue |
|
$ |
135,015 |
|
|
$ |
116,647 |
|
|
$ |
392,814 |
|
|
$ |
293,903 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Certain of the Companys products, including the DuraGen® and NeuraGen product families and
the INTEGRA® Dermal Regeneration Template and wound-dressing products, contain material derived
from bovine tissue. Products that contain materials derived from animal sources, including food as
well as pharmaceuticals and medical devices, are increasingly subject to scrutiny from the press
and regulatory authorities. These products constituted 23% of total revenues in each of the
three-month periods ended September 30, 2007 and 2006, and 23% and 26% of total revenues in each of
the nine-month periods ending September 30, 2007 and 2006, respectively. Accordingly, a widespread
public controversy concerning collagen products, new regulation, or a ban of the Companys products
containing material derived from bovine tissue could have a material adverse effect on the
Companys current business or its ability to expand its business.
Total revenues by major geographic area are summarized below (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
United |
|
|
|
|
|
|
Asia |
|
|
Other |
|
|
|
|
|
|
States |
|
|
Europe |
|
|
Pacific |
|
|
Foreign |
|
|
Total |
|
Three months ended September 30, 2007 |
|
$ |
105,594 |
|
|
$ |
19,460 |
|
|
$ |
4,051 |
|
|
$ |
5,910 |
|
|
$ |
135,015 |
|
Three months ended September 30, 2006 |
|
|
88,740 |
|
|
|
21,165 |
|
|
|
2,815 |
|
|
|
3,927 |
|
|
|
116,647 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine months ended September 30, 2007 |
|
$ |
298,378 |
|
|
$ |
61,155 |
|
|
$ |
14,679 |
|
|
$ |
18,602 |
|
|
$ |
392,814 |
|
Nine months ended September 30, 2006 |
|
|
220,393 |
|
|
|
56,884 |
|
|
|
8,809 |
|
|
|
7,817 |
|
|
|
293,903 |
|
13. COMMITMENTS AND CONTINGENCIES
In consideration for certain technology, manufacturing, distribution and selling rights and
licenses granted to the Company, the Company has agreed to pay royalties on the sales of products
that are commercialized relative to the granted rights and licenses. Royalty payments under these
agreements by the Company were not significant for any of the periods presented.
Various lawsuits, claims and proceedings are pending or have been settled by the Company. The
most significant of those are described below.
In May 2006, Codman & Shurtleff, Inc. (Codman), a division of Johnson & Johnson, commenced
an action in the United States District Court for the District of New Jersey for declaratory
judgment against the Company with respect to United States Patent No. 5,997,895 (the 895 Patent)
held by the Company. The Companys patent covers dural repair technology related to the Companys
DuraGen ® family of duraplasty products.
18
The action seeks declaratory relief that Codmans DURAFORM product does not infringe the
Companys patent and that the Companys patent is invalid. Codman does not seek either damages from
Integra or injunctive relief for selling the DuraGen ® Dural Graft Matrix. The Company has filed a
counterclaim against Codman, alleging that Codmans DURAFORM product infringes the 895 Patent,
seeking injunctive relief preventing the sale and use of DURAFORM, and seeking damages, including
treble damages, for past infringement.
In July 1996, the Company sued Merck KGaA, a German corporation, seeking damages for patent
infringement. The patents in question are part of a group of patents granted to The Burnham
Institute and licensed by the Company that are based on the interaction between a family of cell
surface proteins called integrins and the arginine-glycine-aspartic acid peptide sequence found in
many extra cellular matrix proteins.
The case has been tried, appealed, returned to the trial court and further appealed. Most
recently, on July 27, 2007, the United States Court of Appeals for the Federal Circuit reversed the
judgment of the United States District Court and held that the evidence did not support the jurys
verdict that Merck KGaA infringed on the Companys patents. In October 2007, the parties entered
into a stipulation that concludes the case upon the Companys payment to Merck of fees relating to
certain expenses of Merck. The disposition of this case does not affect any of the Companys
products or development projects.
In addition to these matters, the Company is subject to various claims, lawsuits and
proceedings in the ordinary course of its business, including claims by current or former
employees, distributors and competitors and with respect to its products. In the opinion of
management, such claims are either adequately covered by insurance or otherwise indemnified, or are
not expected, individually or in the aggregate, to result in a material adverse effect on the
Companys financial condition. However, it is possible that the Companys results of operations and
cash flows in a particular period could be materially affected by these contingencies or the costs
related thereto.
Our international operations subject us to customs, import-export and sanctioned country laws.
These laws restrict, and in some cases prohibit, United States companies from directly or
indirectly selling goods, technology or services to people or entities in certain countries. These
laws also prohibit transactions with certain designated persons. In addition, the United States
foreign corrupt practices laws could inhibit our ability to transact business in countries where
companies that are not subject to those laws compete against the Company and engage in practices
that such laws prohibit the Company from engaging in.
Local economic conditions, legal, regulatory or political considerations, the effectiveness of
our sales representatives and distributors, local competition and changes in local medical practice
could also affect our sales to foreign markets. Relationships with customers and effective terms of
sale frequently vary by country, often with longer-term receivables than are typical in the United
States.
The Company accrues for loss contingencies in accordance with Statement of Financial
Accounting Standards No. 5 Accounting for Contingencies; that is, when it is deemed probable
that a loss has been incurred and that loss is estimable. The amounts accrued are based on the full
amount of the estimated loss before considering insurance proceeds, and do not include an estimate
for legal fees expected to be incurred in connection with the loss contingency. The Company
consistently accrues legal fees in connection with loss contingencies as those fees are incurred by
outside counsel as a period cost.
14. SUBSEQUENT EVENT
The Company announced on October 29, 2007 that it had acquired all of the outstanding common
stock of IsoTis, Inc. (IsoTis) for $7.25 in cash per share of IsoTis common stock, representing
total consideration to IsoTis stockholders of approximately $51 million. The Company also repaid
all of IsoTis outstanding $12.6 million in debt at closing.
19
ITEM 2. MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The following discussion and analysis of our financial condition and results of operations
should be read in conjunction with our condensed consolidated financial statements and the related
notes thereto appearing elsewhere in this report and our consolidated financial statements for the
year ended December 31, 2006 included in our Annual Report on Form 10-K.
We have made statements in this report which constitute 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. These forward-looking statements are subject to a number of
risks, uncertainties and assumptions about the Company. Our actual results may differ materially
from those anticipated in these forward-looking statements as a result of many factors, including
but not limited to those set forth under the heading Risk Factors in our Annual Report on Form
10-K for the year ended December 31, 2006 and in subsequent Quarterly Reports on Form 10-Q.
You can identify these forward-looking statements by forward-looking words such as believe,
may, could, will, estimate, continue, anticipate, intend, seek, plan, expect,
should, would and similar expressions in this report.
GENERAL
Integra is a market-leading, innovative medical device company focused on helping the medical
professional enhance the standard of care for patients. Integra provides customers with clinically
relevant, innovative and cost-effective products that improve the quality of life for patients. We
focus on cranial and spinal procedures, peripheral nerve repair, small bone and joint injuries, and
the repair and reconstruction of soft tissue. In the United States, our distribution channels
include two direct sales organizations (Integra NeuroSciences and Integra Reconstructive Surgery),
a network of dealers managed by, and selling in concert with, a direct sales organization (acute
and alternate site surgical instruments and lighting) and strategic alliances. Outside of the
United States, we sell our products directly through sales representatives in major European
markets and through stocking distributors elsewhere. We invest substantial resources and management
effort to develop our sales organizations, and we believe that we compete very effectively in this
aspect of our business.
We present revenues in two categories: Neurosurgical and Orthopedic Implants and Medical
Surgical Equipment. Our Neurosurgical and Orthopedic Implants product group includes collagen
matrices that are indicated for the repair of the dura mater, dermal regeneration and engineered
wound dressings, implants used in small bone and joint fixation, repair of peripheral nerves, and
hydrocephalus management, and implants used in bone regeneration and in guided tissue regeneration
in periodontal surgery. In general, our implant products tend to have higher internal growth rates
than our corporate average, and higher gross margins. Our Medical Surgical Equipment product group
includes ultrasonic surgery systems for tissue ablation, cranial stabilization and brain retraction
systems, instrumentation used in general, neurosurgical, spinal and plastic and reconstructive
surgery and dental procedures, systems for the measurement of various brain parameters, and devices
used to gain access to the cranial cavity and to drain excess cerebrospinal fluid from the
ventricles of the brain. In general, our Medical Surgical Equipment products have lower internal
growth rates than our corporate average, and lower gross margins.
We manage these product groups and distribution channels on a centralized basis. Accordingly,
we report our financial results under a single operating segment the development, manufacturing
and distribution of medical devices.
We manufacture many of our products in various plants located in the United States, Puerto
Rico, France, Germany, Ireland and the United Kingdom. We source most of our hand-held surgical
instruments through specialized third-party vendors.
20
We believe that we have a particular advantage in the development, manufacture and sale of
specialty tissue repair products derived from bovine collagen. Products that contain materials
derived from animal sources, including food as well as pharmaceuticals and medical devices, are
increasingly subject to scrutiny from the press
and regulatory authorities. These products comprised 23% and 26% of total revenues in each of
the nine-month periods ended September 30, 2007 and 2006, respectively. Accordingly, widespread
public controversy concerning collagen products, new regulation, or a ban of our products
containing material derived from bovine tissue, could have a material adverse effect on our current
business and our ability to expand our business.
Our objective is to continue to build a customer-focused and profitable medical device company
by developing or acquiring innovative medical devices and other products to sell through our sales
channels. Our strategy therefore entails substantial growth in revenues through both internal means
through launching new and innovative products and selling existing products more intensively
and by acquiring existing businesses or already successful product lines.
We aim to achieve this growth in revenues while maintaining strong financial results. While we
pay attention to any meaningful trend in our financial results, we focus on measurements that are
indicative of long-term profitable growth. These measurements include revenue growth (derived
through acquisitions and products developed internally), gross margins on total revenues, operating
margins (which we aim to expand on as we leverage our existing infrastructure), and earnings per
fully diluted share of common stock.
ACQUISITIONS
Our strategy for growing our business includes the acquisition of complementary product lines
and companies. Our recent acquisitions of businesses, assets and product lines may make our
financial results for the three- and nine-month periods ended September 30, 2007 not directly
comparable to those of the corresponding prior-year period. See Note 2 to the unaudited condensed
consolidated financial statements for a further discussion. Since the beginning of 2006, we have
acquired the following businesses:
Radionics
On March 3, 2006, Integra acquired certain assets of the Radionics Division of Tyco Healthcare
Group, L.P. (Radionics) for approximately $74.5 million in cash paid at closing, subject to
certain adjustments, and $3.2 million of acquisition-related expenses in a transaction treated as a
business combination. Radionics, based in Burlington, Massachusetts, is a leader in the design,
manufacture and sale of advanced minimally invasive medical instruments in the fields of
neurosurgery and radiation therapy. Radionics products include the CUSA EXcel ultrasonic surgical
aspiration system, the CRW® stereotactic system, the XKnife stereotactic radiosurgery system, and
the OmniSight® EXcel image guided surgery system.
Miltex
On May 12, 2006, we acquired all of the outstanding capital stock of Miltex Holdings, Inc.
(Miltex) for $102.7 million in cash paid at closing, subject to certain adjustments, and $0.7
million of transaction-related costs. Miltex, based in York, Pennsylvania, is a leading provider of
surgical and dental hand instruments to alternate site facilities, which includes physician and
dental offices and ambulatory surgery care sectors. Miltex sells products under the Miltex®,
Meisterhand®, Vantage®, Moyco®, Union Broach®, and Thompson® trade names in over 65 countries,
using a network of independent distributors. Miltex operates a manufacturing and distribution
facility in York, Pennsylvania and also operates a leased facility in Tuttlingen, Germany, where
Miltexs staff coordinates design, production and delivery of instruments.
Canada Microsurgical
On July 5, 2006, we acquired a direct sales force in Canada through the acquisition of our
longstanding distributor; Canada Microsurgical Ltd. (Canada Microsurgical). Canada Microsurgical
has nine sales representatives. We paid $5.8 million (6.4 million Canadian dollars) for Canada
Microsurgical in cash at closing and $0.1 million of transaction-related costs. In addition, we
paid $0.7 million (0.7 million Canadian dollars) this year and may pay up to an additional 1.4
million Canadian dollars over the next two years, depending on the performance of the business.
21
KMI
On July 31, 2006 we acquired the shares of Kinetikos Medical, Inc. (KMI) for $39.5 million
in cash, subject to certain adjustments, including future payments based on the performance of the
KMI business after the acquisition. No such payments were due nor made during 2006 or during the
nine months of 2007. KMI, based in Carlsbad, California, was a leading developer and manufacturer
of innovative orthopedic implants and surgical devices for small bone and joint procedures
involving the foot, ankle, hand, wrist and elbow. KMI marketed products that addressed both the
trauma and reconstructive segments of the extremities market. KMIs reconstructive products are
largely focused on treating deformities and arthritis in small joints of the upper and lower
extremity, while its trauma products are focused on the treatment of fractures of small bones most
commonly found in the extremities.
DenLite
On January 3, 2007, our Companys subsidiary Miltex, Inc. acquired the DenLite product line
from Welch Allyn in an asset purchase, for $2.2 million in cash paid at closing, and approximately
$35,000 of acquisition-related expenses in a transaction treated as a business combination. DenLite
is a lighted mouth mirror to be used in dental procedures.
LXU Healthcare, Inc.
On May 8, 2007, we acquired the shares of LXU Healthcare, Inc. (LXU) for $30.0 million in
cash paid at closing and $0.5 million of acquisition-related expenses. Subsequently, we received
proceeds of $0.4 million from escrow accounts in the third quarter relating to adjustments for
working capital and benefit plans, which was accounted for as a reduction in the total purchase
price. LXU is operated as part of Integras surgical instruments business. LXU, based in West
Boylston, Massachusetts, was comprised of three distinct businesses:
|
|
|
Luxtec The market-leading manufacturer of fiber optic headlight systems for the
medical industry through its Luxtec® brand. The Luxtec products are manufactured in a
31,000 square foot leased facility located in West Boylston. |
|
|
|
|
LXU Medical A leading specialty surgical products distributor with a sales force
calling on surgeons and key clinical decision makers, covering 18,000 operating rooms
in the southeastern, midwestern and mid-Atlantic United States. LXU Medical is the
exclusive distributor of the Luxtec fiber optic headlight systems in these territories. |
|
|
|
|
Bimeco A critical care products distributor with direct sales coverage in the
southeastern United States. |
As was the intention at the time of the acquisition, we are winding down the Bimeco business,
which is not aligned with our strategy. The LXU Medical sales force and distributor network is
being integrated with the Jarit sales and distribution organization.
Physician Industries
On May, 11, 2007, we acquired certain assets of the pain management business of Physician
Industries, Inc. (Physicians Industries) for $4.0 million in cash, subject to certain adjustments
and approximately $74,000 of acquisition-related expenses. In addition, we may pay additional
amounts over the next four years depending on the performance of the business. Physician
Industries, located in Salt Lake City, Utah, assembles, markets, and sells a comprehensive line of
pain management products for acute and chronic pain, including customized trays for spinal,
epidural, nerve block, and biopsy procedures. The Physician Industries business will be combined
with our similar Spinal Specialties line and sold under the name Integra Pain Management.
IsoTis see Note 14 to the unaudited condensed consolidated financial statements.
22
IMPACT OF RESTRUCTURING ACTIVITIES
In October 2006, we announced plans to restructure our French sales and marketing
organization, which includes elimination of a number of positions at our Biot, France facility, and
the closing of our facility in Nantes, France. These activities have been transferred to the sales
and marketing headquarters in Lyon, France and payments should be completed in early 2008.
In connection with these restructuring activities, we updated our estimate of employee
termination costs based on the final settlement of those obligations and reduced our provisions by
$0.3 million during the nine months ended September 30, 2007. We recorded net reversals of
previously recorded provisions based on the final settlement of those obligations. While we expect
to achieve a positive impact from the restructuring and integration activities, such results remain
uncertain. We have reinvested most of the savings from these restructuring and integration
activities into further expanding our European sales, marketing and distribution organization, and
integrating the Radionics, KMI and Newdeal businesses into our existing sales and distribution
network.
RESULTS OF OPERATIONS
Net income for the three months ended September 30, 2007 was $9.7 million, or $0.33 per
diluted share, as compared with net income of $2.6 million, or $0.09 per diluted share, for the
three months ended September 30, 2006.
Net income for the nine months ended September 30, 2007 was $28.1 million, or $0.94 per
diluted share, as compared with a net income of $19.3 million, or $0.64 per diluted share, for the
nine months ended September 30, 2006.
These amounts include the following charges (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
|
September 30, |
|
|
September 30, |
|
|
|
2007 |
|
|
2006 |
|
|
2007 |
|
|
2006 |
|
Acquisition-related charges: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Inventory fair market value purchase accounting
adjustments |
|
$ |
1,239 |
|
|
$ |
1,399 |
|
|
$ |
2,870 |
|
|
$ |
4,012 |
|
Acquired in-process research and development |
|
|
|
|
|
|
5,600 |
|
|
|
|
|
|
|
5,600 |
|
Charges associated with convertible debt exchange offering |
|
|
|
|
|
|
1,792 |
|
|
|
|
|
|
|
1,879 |
|
Charges associated with termination of interest rate swap |
|
|
|
|
|
|
1,425 |
|
|
|
|
|
|
|
1,425 |
|
Employee termination and related costs |
|
|
130 |
|
|
|
63 |
|
|
|
(29 |
) |
|
|
440 |
|
Facility consolidation, acquisition integration,
manufacturing transfer, enterprise business system,
integration and related costs |
|
|
93 |
|
|
|
582 |
|
|
|
778 |
|
|
|
1,299 |
|
Litigation settlements |
|
|
138 |
|
|
|
|
|
|
|
138 |
|
|
|
|
|
Impairment of inventory and fixed assets related to
discontinued development project and product lines |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,578 |
|
Charges associated with discontinued or withdrawn product
lines |
|
|
|
|
|
|
|
|
|
|
1,456 |
|
|
|
|
|
Intangible asset impairments |
|
|
|
|
|
|
|
|
|
|
1,014 |
|
|
|
|
|
Charges related to restructuring European legal entities |
|
|
|
|
|
|
|
|
|
|
335 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
1,600 |
|
|
$ |
10,861 |
|
|
$ |
6,562 |
|
|
$ |
16,233 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Of these amounts, $4.7 million and $5.4 million were charged to cost of product revenues in
the nine-month periods ended September 30, 2007 and 2006, respectively, and $7.2 million was
charged to research and development in the three and nine months ended September 30, 2006. The
remaining amounts were primarily charged to selling, general and administrative expenses and
intangible asset amortization.
23
Employee termination and related costs for the nine months ended September 30, 2007 reflect
the reversal of previously recorded accruals for anticipated terminations due to changes in
estimates during the second quarter. Charges associated with discontinued or withdrawn product
lines reflect the discontinuation of the Endura line of
dural repair products distributed by the Company for Shelhigh, Inc. Intangible asset
impairments include termination of various trademarks associated with the Spinal Specialties
business as such products will now be re-branded as part of Integra Pain Management, and the
impairment of certain other technology and trademarks based on business and operating decisions
during the second quarter of 2007.
We believe that, given our strategy of seeking new acquisitions and integrating recent
acquisitions, our current focus on rationalizing our existing manufacturing and distribution
infrastructure, our recent review of various product lines in relation to our current business
strategy, and a renewed focus on enterprise business systems integrations, charges similar to those
discussed above could recur with similar materiality in the future. We believe that the delineation
of these costs provides useful information to measure the comparative performance of our business
operations.
During
the three and nine months ended September 30, 2007, the Company
recognized increases to net
income of $0.9 million and $0.6 million, respectively, related to prior
periods. The Company has deemed the amounts immaterial and, therefore, recorded such increases in
the respective current periods.
Revenues and Gross Margin on Product Revenues
Our revenues and gross margin on product revenues were as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
|
September 30, |
|
|
September 30, |
|
|
|
2007 |
|
|
2006 |
|
|
2007 |
|
|
2006 |
|
Medical Surgical Equipment and other |
|
$ |
85,873 |
|
|
$ |
73,511 |
|
|
$ |
247,177 |
|
|
$ |
175,125 |
|
Neurosurgical and Orthopedic Implants |
|
|
49,142 |
|
|
|
43,136 |
|
|
|
145,637 |
|
|
|
118,778 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenue |
|
|
135,015 |
|
|
|
116,647 |
|
|
|
392,814 |
|
|
|
293,903 |
|
Cost of product revenues |
|
|
50,863 |
|
|
|
47,559 |
|
|
|
152,248 |
|
|
|
116,869 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross margin on total revenues |
|
$ |
84,152 |
|
|
$ |
69,088 |
|
|
$ |
240,566 |
|
|
$ |
177,034 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross margin as a percentage of total revenues |
|
|
62 |
% |
|
|
59 |
% |
|
|
61 |
% |
|
|
60 |
% |
THREE MONTHS ENDED SEPTEMBER 30, 2007 AS COMPARED TO THE THREE MONTHS ENDED SEPTEMBER 30, 2006
Revenues and Gross Margin
For the three-month period ended September 30, 2007, total revenues increased by $18.4
million, or 16%, to $135.0 million from $116.6 million for the same period last year. Domestic
revenues increased by $16.9 million to $105.6 million from $88.7 million, or 78% of total revenues,
as compared to 76% of revenues in the three months ended September 30, 2006. International revenues
increased to $29.4 million from $27.9 million in the prior-year period, an increase of 5%.
The Neurosurgical and Orthopedic Implants category grew 14% over the prior year. Sales of our
bone repair products, extremity reconstruction implants, and dermal repair products led the revenue
growth. Nerve and tendon repair products, the Newdeal ® family of products and private-label
products all experienced strong year-over-year growth in the third quarter. Adverse regional
reimbursement decisions tempered sales of our dermal products into the wound-healing indication.
KMI products, which are sold into the extremities indication, contributed $2.5 million of sales in
the third quarter of 2007.
24
The Medical Surgical Equipment category grew 17% over the prior year. The majority of the
increase was due to acquired products. Revenues from the LXU/Luxtec and Physician Industries and
non-Integra distributed products sold through our former Canadian distributor (all acquired during
the last twelve months) contributed $13.0 million of sales in the third quarter of 2007, compared
to $16.3 million in revenue from products acquired in the
prior year for the same period in 2006. The Miltex and Jarit surgical instrument lines and the
Mayfield cranial stabilization products led internally generated growth. Growth in these product
lines was offset by lower sales of ultrasonic aspirator products in the third quarter of 2007
compared to the prior-year period. Ultrasonic aspirator product sales were unusually high in the
third quarter of 2006 because of initial stocking orders from certain foreign distributors which
took over distribution from Tyco affiliates.
Included in revenues are royalties of $2.5 million and $7.6 million, respectively, for the
three and nine months ended September 30, 2007 and $1.8 million and $5.5 million for the three and
nine months ended September 30, 2006.
We have generated our product revenue growth through acquisitions, new product launches and
increased direct sales and marketing efforts both domestically and in Europe. We expect that our
expanded domestic sales force, the continued implementation of our direct sales strategy in Europe
and sales of internally developed and acquired products will drive our future revenue growth. We
also intend to continue to acquire businesses that complement our existing businesses and products.
Many of our recent acquisitions involve businesses or product lines that overlap in some way with
our existing products. Our sales and marketing departments are integrating these acquisitions, and
there has been, and we expect there will continue to be, some cannibalization of sales of our
existing products that will affect our internal growth.
Gross margin increased by $15.1 million to $84.2 million for the three-month period ended
September 30, 2007, from $69.1 million for the same period last year. Gross margin as a percentage
of total revenue is 62% for the third quarter 2007, compared to 59% in 2006. Cost of goods sold
included inventory fair value purchase accounting adjustments from acquisitions of $1.2 million and
$1.4 million, respectively, for the three months ended September 30, 2007 and 2006. We also
recognized a $1.3 million change in estimate related to consignment inventory and $0.6 million in
restructuring and manufacturing transfer and systems integration costs during the third quarter of
2006. All together these charges reduced our gross margin in the third quarter of 2006 by
approximately 2 percentage points.
In the absence of acquisitions, we expect that the faster internal growth of our higher margin
implant products will increase their proportion of total product revenues and therefore our
consolidated gross margins will increase to reflect that trend.
Other Operating Expenses
The following is a summary of other operating expenses as a percent of total revenues (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
September 30, |
|
|
|
2007 |
|
|
2006 |
|
Research and development |
|
|
5 |
% |
|
|
9 |
% |
Selling, general and administrative |
|
|
42 |
% |
|
|
37 |
% |
Intangible asset amortization |
|
|
2 |
% |
|
|
2 |
% |
|
|
|
|
|
|
|
Total other operating expenses |
|
|
49 |
% |
|
|
49 |
% |
|
|
|
|
|
|
|
Total other operating expenses, which consist of research and development expense, selling,
general and administrative expense and amortization expense, increased $8.5 million, or 15%, to
$65.8 million in the third quarter of 2007, compared to $57.3 million in the third quarter of 2006.
Research and development expenses decreased by $4.5 million to $6.5 million in the third quarter of
2007 compared to $11.0 million in the same period last year. Research and development expenses in
the third quarter of 2006 included a $5.6 million in-process research and development (IPR&D)
charge related to the acquisition of KMI. In 2007 there was no IPR&D charge, however we did
increase spending on our biomaterial development programs.
In 2007, we continued to direct our research and development expenses toward expanding the
indications for use of our absorbable implant technology products, including a multi-center
clinical trial suitable to support an application to the FDA for approval of the DuraGen Plus®
Adhesion Barrier Matrix product in the United States.
25
Selling, general and administrative expenses in the third quarter of 2007 increased by $12.8
million to $56.2 million, or 42% of revenue, compared to $43.4 million, or 37% of revenue, in the
same period last year. The increase in selling, general and administrative expense over the prior
year was due primarily to substantial increases in the size of our selling organizations,
particularly for spine and extremity reconstruction, and higher expenses for corporate staff and
consulting. As we gain more leverage from our larger selling organizations, we expect selling,
general and administrative expenses to decrease to between 38% and 40% of revenue over the
remainder of 2007 and into 2008.
While we expect a slowing in the growth of the spending on our direct sales and marketing
organizations in the direct selling platforms, we will continue to increase corporate staff to
support the recent growth in our business and to integrate acquired businesses. Additionally, we
have incurred higher operating costs in connection with our recent investments in our
infrastructure, including the continued implementation of an enterprise business system and the
relocation and expansion of our domestic and international distribution capabilities through
third-party service providers. We also have incurred additional expenses in connection with the
hiring of consultants to support some corporate staff functions. We expect to continue to incur
costs related to these activities in 2007 and 2008 as we complete these on-going projects.
Amortization expense increased by $0.1 million to $3.0 million in the third quarter of 2007
compared to $2.9 million in the same period last year.
Non-Operating Income and Expenses
The following is a summary of non-operating income and expenses (in thousands):
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
September 30, |
|
|
|
2007 |
|
|
2006 |
|
Interest income |
|
$ |
1,518 |
|
|
$ |
375 |
|
Interest (expense) |
|
|
(3,863 |
) |
|
|
(4,362 |
) |
Other income (expense) |
|
|
(325 |
) |
|
|
(1,765 |
) |
Interest Income
Interest income increased in the three-month period ended September 30, 2007, compared to the
same period last year, primarily due to higher average cash and investment balances. The average
balance on our cash and investments was approximately $130.9 million in the three month period
ended September 30, 2007, compared to approximately $36.0 million for the same period last year.
Interest Expense
Interest expense decreased in the three-month period ended September 30, 2007, compared to the
same period last year, primarily due to decreases in outstanding borrowings under our $300 million
senior secured credit facility, partially offset by interest expense on our convertible notes due
2010 and 2012 which were issued on June 11, 2007. We had no outstanding borrowings under the credit
facility as of September 30, 2007.
Our reported interest expense for the three-month periods ended September 30, 2007 and 2006
includes amortization of $0.7 million and $0.2 million of debt issuance costs, respectively. Debt
issuance costs associated with the 2010 and 2012 convertible notes were $3.8 million for each
series and are being amortized using the straight-line method over the three- and five-year terms
of the notes.
We may pay additional interest on our convertible notes due in 2008 under certain conditions.
The fair value of this contingent interest obligation is marked to its fair value at each balance
sheet date, with changes in the fair value recorded to interest expense. The changes in the
estimated fair value of the contingent interest obligation increased interest expense by $0.3
million and $0.1 million for the three months ended September 30, 2007 and 2006, respectively.
26
We had an interest rate swap agreement with a $50 million notional amount to hedge the risk of
changes in fair value attributable to interest rate risk with respect to a portion of our fixed
rate convertible notes. The net amount to be paid or received under the interest rate swap
agreement was recorded as a component of interest expense. Interest expense associated with the
interest rate swap for the three months ended September 30, 2006 was $0.3 million. On September 27,
2006, we terminated this interest rate swap agreement in connection with the exchange of our
convertible notes due in 2008 and paid the counterparty approximately $2.2 million consisting of a
$0.6 million payment of accrued interest and a $1.6 million payment representing the fair market
value of the interest rate swap on the termination date. Because we terminated this swap
agreement, we did not incur any expense for the three months ended September 30, 2007 associated
with this swap.
Other Income (Expense)
Other expenses decreased in the three-month period ended September 30, 2007, compared to the
same period last year, primarily due to the $1.6 million payment representing the fair market value
of the interest rate swap on the termination date and realized losses on the sale of investments in
the third quarter of 2006.
Income Taxes
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
September 30, |
|
(in thousands) |
|
2007 |
|
|
2006 |
|
Income before income taxes |
|
$ |
15,666 |
|
|
$ |
6,062 |
|
Income tax expense |
|
|
5,993 |
|
|
|
3,468 |
|
|
|
|
|
|
|
|
Net income |
|
|
9,673 |
|
|
|
2,594 |
|
|
|
|
|
|
|
|
Effective tax rate |
|
|
38.3 |
% |
|
|
57.2 |
% |
Our effective income tax rate for the three months ended September 30, 2007 and 2006 was 38.3%
and 57.2%, respectively. The third quarter of 2006 included a $5.6 million in-process research and
development charge related to the KMI acquisition, which is not deductible for tax purposes. The
change in the effective tax rate year-over-year was primarily due to changes in the geographic mix
of taxable income offset by the non-deductible IPR&D charge.
Our effective tax rate may vary from period to period depending on, among other factors, the
geographic and business mix of taxable earnings and losses. We consider these factors and others,
including our history of generating taxable earnings, in assessing our ability to realize deferred
tax assets.
NINE MONTHS ENDED SEPTEMBER 30, 2007 AS COMPARED TO THE NINE MONTHS ENDED SEPTEMBER 30, 2006
Revenues and Gross Margin
For the nine-month period ended September 30, 2007, total revenues increased 34% over the
prior-year period to $392.8 million. Domestic revenues increased by $78.0 million to $298.4 million
and were 76% of total revenues, as compared to 75% of revenues in the nine months ended September
30, 2006. International revenues increased $20.9 million to $94.4 million, an increase of 28%.
The Neurosurgical and Orthopedic Implants category grew 23% over the prior year. Sales of our
DuraGen® family of products, extremity reconstruction implants, and bone repair products led the
revenue growth, offsetting the impact of the recall of the Endura products and slow growth in
sales of dermal repair products. KMI products contributed $7.1 million of sales in the first three
quarters of 2007 compared to $1.8 million in the same period last year. The Medical Surgical
Equipment category grew 41% over the prior year. Acquired products, surgical instruments,
ultrasonic surgical systems, and Mayfield cranial stabilization products provided most of the
year-over-year growth.
27
Gross margin increased by $63.6 million to $240.6 million for the nine-month period ended
September 30, 2007, from $177.0 million for the same period last year. Gross margin as a percentage
of total revenue was 61% for the first three quarters of 2007, compared to 60% in 2006.
In the absence of acquisitions, we expect that the faster internal growth of our higher margin
implant products will increase their proportion of total product revenues and therefore our
consolidated gross margins will increase to reflect that trend. Should we acquire Medical Surgical
Equipment businesses or product lines with lower gross margins, as we have from time to time in the
past, such acquisitions would have the effect of slowing or reversing the favorable impact on gross
margins of the more quickly growing implants products.
Other Operating Expenses
The following is a summary of other operating expenses as a percent of total revenues (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended |
|
|
|
September 30, |
|
|
|
2007 |
|
|
2006 |
|
Research and development |
|
|
5 |
% |
|
|
7 |
% |
Selling, general and administrative |
|
|
41 |
% |
|
|
38 |
% |
Intangible asset amortization |
|
|
2 |
% |
|
|
2 |
% |
Total other operating expenses |
|
|
48 |
% |
|
|
47 |
% |
Total other operating expenses, which consist of research and development expense, selling,
general and administrative expense and amortization expense, increased $50.4 million, or 36%, to
$188.8 million in the first nine months of 2007, compared to $138.4 million in the same period last
year.
Research and development expenses in the first nine months of 2007 decreased by $1.7 million
to $18.8 million, compared to $20.5 million in the same period last year. Research and development
expenses in 2006 included a $5.6 million in-process research and development charge associated with
the KMI acquisition and a charge of $1.6 million for the discontinuation of a development project.
In 2007, we continued to direct our research and development expenses toward expanding the
indications for use of our absorbable implant technology products, including a multi-center
clinical trial suitable to support an application to the FDA for approval of the DuraGen Plus®
Adhesion Barrier Matrix product in the United States.
Selling, general and administrative expenses in the nine months ended September 30, 2007
increased by $48.5 million to $160.3 million, compared to $111.8 million in the same period last
year. Selling and marketing expenses increased by $25.0 million primarily due to the accelerated
ramp up in our extremities reconstructive, intensive care unit specialist and spine sales forces
and the impact of acquisitions. General and administrative expenses increased $23.5 million in the
nine months of 2007 compared to the same period last year primarily because of the impact of
acquisitions and increases in headcount, compensation, and consulting services charged to corporate
operations.
We do not expect substantial further increases in our direct sales and marketing organizations
for our direct selling platforms this year, but will continue to increase corporate staff to
support the recent growth in our business and to integrate acquired businesses. Additionally, we
have incurred higher operating costs in connection with our recent investments in our
infrastructure, including the continued implementation of an enterprise business system and the
relocation and expansion of our domestic and international distribution capabilities through
third-party service providers. We also have incurred additional expenses in connection with the
hiring of consultants to support some corporate staff functions. We expect to continue to incur
costs related to these activities in 2007 as we complete these on-going projects.
Amortization expense increased by $3.5 million to $9.7 million in the first nine months of
2007 compared to $6.2 million in the same period last year. The increase was primarily related to
intangible assets of Miltex and KMI acquired in 2006, intangible assets of DenLite, LXU and
Physician Industries acquired in 2007 and the impact of impairment charges recorded in the second
quarter of 2007.
28
Non-Operating Income and Expenses
The following is a summary of non-operating income and expenses (in thousands):
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended |
|
|
|
September 30, |
|
|
|
2007 |
|
|
2006 |
|
Interest income |
|
$ |
2,378 |
|
|
$ |
1,993 |
|
Interest (expense) |
|
|
(9,896 |
) |
|
|
(8,117 |
) |
Other income (expense) |
|
|
(229 |
) |
|
|
(1,832 |
) |
Interest Income
Interest income increased in the nine-month period ended September 30, 2007, compared to the
same period last year, primarily due to higher returns on cash and investments. The average yield
on our cash and investments was 5.0% for the nine-month period ended September 30, 2007, compared
to approximately 3.1% for the same period last year.
Interest Expense
Interest expense increased in the nine-month period ended September 30, 2007, compared to the
same period last year, primarily due to increases in average outstanding borrowings under our $300
million senior secured credit facility. We made net additional borrowings under our credit facility
during the nine months ended September 30, 2007, but we repaid the entire amount of the outstanding
loan on June 11, 2007 following the issuance of $330 million of convertible notes. We had no
outstanding borrowings under the credit facility as of September 30, 2007.
We also incurred additional interest expense on our convertible notes due 2010 and 2012, which
were issued on June 11, 2007. The 2010 Notes and the 2012 Notes bear interest at a rate of 2.75%
and 2.375% per annum, respectively, in each case payable semi-annually in arrears on December 1 and
June 1 of each year.
Our reported interest expense for the nine-month periods ended September 30, 2007 and 2006
includes $1.2 million and $0.6 million, respectively, of non-cash amortization of debt issuance
costs.
Changes in the fair value of the contingent interest obligation increased interest expense by
$0.5 million and $0.3 million in the nine months ended September 30, 2007 and 2006, respectively.
Interest expense associated with the interest rate swap for the nine months ended September 30,
2006 was $0.8 million. On September 27, 2006, we terminated this interest rate swap agreement in
connection with the exchange of our convertible notes and paid the counterparty approximately $2.2
million consisting of a $0.6 million payment of accrued interest and a $1.6 million payment
representing the fair market value of the interest rate swap on the termination date. Because we
terminated this swap agreement, we did not incur any expense for the nine months ended September
30, 2007 associated with this swap.
Other Income (Expense)
Other expense decreased in the nine-month period ended September 30, 2007, compared to the
same period last year, primarily due to $1.6 million payment representing the fair market value of
the interest rate swap on the termination date and realized losses on the sale of investments in
the third quarter of 2006. This decrease was partially offset by $0.1 million of foreign exchange
losses realized in the nine months ended September 30, 2007.
29
Income Taxes
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended |
|
|
|
September 30, |
|
(in thousands) |
|
2007 |
|
|
2006 |
|
Income before income taxes |
|
$ |
43,987 |
|
|
$ |
30,640 |
|
Income tax expense |
|
|
15,898 |
|
|
|
11,364 |
|
|
|
|
|
|
|
|
Net income |
|
|
28,089 |
|
|
|
19,276 |
|
|
|
|
|
|
|
|
Effective tax rate |
|
|
36.1 |
% |
|
|
37.1 |
% |
Our effective income tax rate for the nine months ended September 30, 2007 and 2006 was 36.1%
and 37.1%, respectively. The third quarter of 2006 included a $5.6 million in-process research and
development charge associated with the KMI acquisition, which is not deductible for tax purposes.
The change in the effective income tax rate year-over-year was primarily due to approximately $0.7
million of taxes incurred in connection with the Companys restructuring of its European entities,
the changes in the geographic mix of taxable income due in part to recently acquired businesses and
the non-deductible IPR&D charge in the prior year.
Our effective tax rate may vary from period to period depending on, among other factors, the
geographic and business mix of taxable earnings and losses. We consider these factors and others,
including our history of generating taxable earnings, in assessing our ability to realize deferred
tax assets.
INTERNATIONAL PRODUCT REVENUES AND OPERATIONS
Product revenues by major geographic area are summarized below (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
United |
|
|
|
|
|
|
Asia |
|
|
Other |
|
|
|
|
|
|
States |
|
|
Europe |
|
|
Pacific |
|
|
Foreign |
|
|
Total |
|
Three months ended September 30, 2007 |
|
$ |
105,594 |
|
|
$ |
19,460 |
|
|
$ |
4,051 |
|
|
$ |
5,910 |
|
|
$ |
135,015 |
|
Three months ended September 30, 2006 |
|
|
88,740 |
|
|
|
21,165 |
|
|
|
2,815 |
|
|
|
3,927 |
|
|
|
116,647 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine months ended September 30, 2007 |
|
$ |
298,378 |
|
|
$ |
61,155 |
|
|
$ |
14,679 |
|
|
$ |
18,602 |
|
|
$ |
392,814 |
|
Nine months ended September 30, 2006 |
|
|
220,393 |
|
|
|
56,884 |
|
|
|
8,809 |
|
|
|
7,817 |
|
|
|
293,903 |
|
For the three months ended September 30, 2007, revenues from customers outside the United
States totaled $29.4 million, or 22% of total revenues, of which approximately 66% were to European
customers. Foreign exchange positively affected revenues by $1.3 million in the quarter. Revenues
from customers outside the United States included $17.9 million of revenues generated in foreign
currencies.
In the three months ending September 30, 2006, revenues from customers outside the United
States totaled $27.9 million, or 24% of total revenues, of which approximately 76% were from
European customers. Revenues from customers outside the United States included $22.3 million of
revenues generated in foreign currencies.
For the nine months ended September 30, 2007, revenues from customers outside the United
States totaled $94.4 million, or 24% of total revenues, of which approximately 65% were to European
customers. Revenues from customers outside the United States included $58.9 million of revenues
generated in foreign currencies.
In the nine months ending September 30, 2006, revenues from customers outside the United
States totaled $73.5 million, or 25% of total revenues, of which approximately 77% were from
European customers. Revenues from customers outside the United States included $52.9 million of
revenues generated in foreign currencies.
Additionally, we generate significant revenues outside the United States, a portion of which
are U.S. dollar-denominated transactions conducted with customers who generate revenue in
currencies other than the U.S. dollar. As a result, currency fluctuations between the U.S. dollar
and the currencies in which those customers do business may have an impact on the demand for our
products in foreign countries.
30
Because we have operations based in Europe and we generate revenues and incur operating
expenses in Euros and British pounds, we experience currency exchange risk with respect to those
foreign currency denominated revenues or expenses. A weakening of the dollar against the Euro and
British pound could positively affect future revenues and negatively affect future gross margins
and operating margins, while a strengthening of the dollar against the Euro and the British pound
could negatively affect future revenues and positively affect future gross margins and operating
margins. We are exposed to various market risks, including changes in foreign currency exchange
rates and interest rates that could adversely affect our results of operations and financial
condition. We do not hold or issue derivative instruments for trading or other speculative
purposes. As the volume of our business transacted in foreign currencies increases, we will
continue to assess the potential effects that changes in foreign currency exchange rates could have
on our business. If we believe this potential impact presents a significant risk to our business,
we may enter into additional derivative financial instruments to mitigate this risk.
Local economic conditions, regulatory or political considerations, the effectiveness of our
sales representatives and distributors, local competition and changes in local medical practice all
may combine to affect our sales into markets outside the United States.
Relationships with customers and effective terms of sale frequently vary by country, often
with longer-term receivables than are typical in the United States.
LIQUIDITY AND CAPITAL RESOURCES
Cash and Marketable Securities
At September 30, 2007, we had cash, cash equivalents and current and non-current investments
totaling approximately $129.5 million. Our investments consist almost entirely of highly liquid,
interest bearing-debt securities.
Cash Flows
Cash provided by operations has recently been and is expected to continue to be our primary
means of funding existing operations and capital expenditures. We generated positive operating cash
flows of $50.8 million for the nine months ended September 30, 2006 and $71.7 million for the year
ended December 31, 2006. Cash flows from operating activities decreased to $32.4 million for the
nine months ended September 30, 2007, due primarily to increases in inventory and income tax
payments. Inventory increased for the period ending September 30, 2007 from the year ended
December 31, 2006 due to the start up of manufacturing in Ireland and planned increases to support
greater extremity reconstruction and surgical instrument sales anticipated for the fourth quarter
of 2007. Higher net income and improvement in accounts receivable collections added cash flows to
partially reduce these cash outflows.
Cash used in investing activities for the nine months ended September 30, 2007, was $53.3
million. The Company closed three acquisitions for a total of $36.4 million and had capital
expenditures of $17.2 million in this period.
Cash provided by financing activities was $126.3 million for the nine months ended September
30, 2007, consisting primarily of gross proceeds from the issuance of the 2010 and 2012 convertible
notes of $330.0 million, sales of the stock purchase warrants of $21.7 million and exercise of
stock options of $16.6 million. Partially offsetting these cash inflows were net payments of $100.1
million to pay down the entire amount outstanding under our credit facility, $86.1 million for the
repurchase of 1.7 million shares of our common stock, $46.8 million to purchase call options with
respect to our common stock which are designed to mitigate potential dilution from the conversion
of the notes and the payment of $9.2 million of bond issuance costs.
Working Capital
At
September 30, 2007 and December 31, 2006, working capital
was $192.2 million and $(52.4)
million, respectively. The increase in working capital is primarily related to the net proceeds
received from the issuance of long-term convertible notes, which increased cash and which was also used to pay down the
senior credit facility balance which had been classified as current.
31
Convertible Debt and Senior Secured Revolving Credit Facility
2008 Contingent Convertible Subordinated Notes
We pay interest on our $120 million contingent convertible subordinated notes (the 2008
Notes) at an annual rate of 2.5% each September 15 and March 15. We will also pay contingent
interest on the 2008 Notes if, at thirty days prior to maturity, our common stock price is greater
than $37.56. The contingent interest will be payable at maturity for each of the last three years
the 2008 Notes remain outstanding in an amount equal to the greater of (1) 0.50% of the face amount
of the 2008 Notes and (2) the amount of regular cash dividends paid during each such year on the
number of shares of common stock into which each 2008 Note is convertible. Holders of the 2008
Notes may convert the 2008 Notes under certain circumstances, including when the market price of
our common stock on the previous trading day is more than $37.56 per share, based on an initial
conversion price of $34.15 per share. During the nine months ended September 30, 2007, our stock
price exceeded $37.56, and $38,000 of the 2008 Notes have been converted to common stock or cash.
The 2008 Notes are general, unsecured obligations of Integra and are subordinate to any senior
indebtedness. We cannot redeem the 2008 Notes prior to their maturity, and the 2008 Notes holders
may compel us to repurchase the 2008 Notes upon a change of control. There are no financial
covenants associated with the convertible 2008 Notes.
2010 and 2012 Senior Convertible Notes
On June 11, 2007, the Company issued $165 million aggregate principal amount of its 2.75%
Senior Convertible Notes due 2010 (the 2010 Notes) and $165 million aggregate principal amount of
its 2.375% Senior Convertible Notes due 2012 (the 2012 Notes and together with the 2010 Notes,
the Notes). The 2010 Notes and the 2012 Notes bear interest at a rate of 2.75% per annum and
2.375% per annum, respectively, in each case payable semi-annually in arrears on December 1 and
June 1 of each year.
The Notes are senior, unsecured obligations of the Company, and are convertible into cash and,
if applicable, shares of our common stock based on an initial conversion rate, subject to
adjustment, of 15.0917 shares per $1,000 principal amount of notes for the 2010 Notes and 15.3935
shares per $1,000 principal amount of notes for the 2012 Notes (which represents an initial
conversion price of approximately $66.26 per share and approximately $64.96 per share for the 2010
Notes and the 2012 Notes, respectively.) The Company will satisfy any conversion of the Notes with
cash up to the principal amount of the applicable series of Notes pursuant to the net share
settlement mechanism set forth in the applicable indenture and, with respect to any excess
conversion value, with shares of the Companys common stock. The Notes are convertible only in the
following circumstances: (1) if the closing sale price of the Companys common stock exceeds 130%
of the conversion price during a period as defined in the indenture; (2) if the average trading
price per $1,000 principal amount of the Notes is less than or equal to 97% of the average
conversion value of the Notes during a period as defined in the indenture; (3) at any time on or
after December 15, 2009 (in connection with the 2010 Notes) or anytime after December 15, 2011 (in
connection with the 2012 Notes); or (4) if specified corporate transactions occur. The issue price
of the Notes was equal to their face amount, which is also the amount holders are entitled to
receive at maturity if the Notes are not converted. As of September 30, 2007, none of these
conditions existed and, as a result, the $330 million balance of the 2010 Notes and the 2012 Notes
is classified as long-term.
Holders of the Notes, who convert their Notes in connection with a qualifying fundamental
change, as defined in the related indenture, may be entitled to a make-whole premium in the form of
an increase in the conversion rate. Additionally, following the occurrence of a fundamental change,
holders may require that Integra repurchase some or all of the Notes for cash at a repurchase price
equal to 100% of the principal amount of the notes being repurchased, plus accrued and unpaid
interest, if any.
32
The Notes, under the terms of the private placement agreement, are guaranteed fully by Integra
LifeSciences Corporation, a subsidiary of the Company. The 2010 Notes will rank equal in right of
payment to the 2012 Notes. The Notes will be the Companys direct senior unsecured obligations and
will rank equal in right of payment to all of the Companys existing and future unsecured and unsubordinated indebtedness.
In connection with the issuance of the Notes, the Company entered into call transactions and
warrant transactions, primarily with affiliates of the initial purchasers of the Notes (the hedge
participants), in connection with each series of Notes. The cost of the call transactions to the
Company was approximately $46.8 million. The Company received approximately $21.7 million of
proceeds from the warrant transactions. The call transactions involve the Companys purchasing call
options from the hedge participants and the warrant transactions, which involve the Companys
selling call options to the hedge participants with a higher strike price than the purchased call
options.
The initial strike price of the call transactions is (1) for the 2010 Notes, approximately
$66.26 per share of Common Stock, and (2) for the 2012 Notes, approximately $64.96, in each case
subject to anti-dilution adjustments substantially similar to those in the Notes. The initial
strike price of the warrant transactions is (x) for the 2010 Notes, approximately $77.96 per share
of Common Stock and (y) for the 2012 Notes, approximately $90.95, in each case subject to customary
anti-dilution adjustments.
Senior Secured Revolving Credit Facility
The Company has a $300 million, five-year, senior secured revolving credit facility, which
it utilizes for working capital, capital expenditures, share repurchases, acquisitions and
other general corporate purposes. We had no outstanding borrowings under the credit facility as
of September 30, 2007.
We amended the credit facility in September 2007 to accommodate the acquisition of IsoTis as
well as other acquisitions. The amendment modified certain financial and negative covenants which
include the addition of up to $14.7 million of cost savings to the calculation of our Consolidated
EBITDA as well as an increase in the Total Leverage ratio from 4.0 to 4.5 to 1 through June 30,
2008.
Share Repurchase Plan
On May 17, 2007, the Companys Board of Directors authorized the Company to repurchase shares
of its common stock for an aggregate purchase price not to exceed $75 million through December 31,
2007. The Company did not repurchase any shares of its common stock under this program. On
October 30, 2007, the Companys Board of Directors terminated the repurchase authorization it
adopted on May 17, 2007 and authorized the company to repurchase shares of its common stock for an
aggregate purchase price not to exceed $75 million through December 31, 2008. Shares may be
purchased either in the open market or in privately negotiated transactions. As of September 30,
2007, there remained $75 million available for share repurchases under this authorization. The
Company did not purchase any shares of its common stock under the repurchase program during the
three months ended September 30, 2007. See Note 9 to the unaudited condensed consolidated
financial statements.
Dividend Policy
We have not paid any cash dividends on our common stock since our formation. Our credit
facility limits the amount of dividends that we may pay. Any future determinations to pay cash
dividends on our common stock will be at the discretion of our Board of Directors and will depend
upon our financial condition, results of operations, cash flows and other factors deemed relevant
by the Board of Directors.
Requirements and Capital Resources
We believe that our cash, borrowings under the senior secured revolving credit facility and
cash flow from operations are sufficient to finance our operations and capital expenditures in the
near term. We make regular borrowings and payments each month against the credit facility and
consider the outstanding amounts to be short-term in nature. See Convertible Debt and Senior
Secured Revolving Credit Facility for a description of the material terms of our credit facility.
33
We announced on October 29, 2007 that we had acquired all of the outstanding common stock of
IsoTis, Inc. (IsoTis) for $7.25 in cash per share of IsoTis common stock, representing total
consideration to IsoTis stockholders of approximately $51 million. We also repaid all of IsoTis outstanding $12.6
million in debt at closing.
Contractual Obligations and Commitments
As of September 30, 2007, we were obligated to pay the following amounts under various
agreements:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Less than |
|
|
1-3 |
|
|
3-5 |
|
|
More than |
|
|
|
Total |
|
|
1 year |
|
|
Years |
|
|
Years |
|
|
5 years |
|
|
|
(in millions) |
|
Convertible Securities |
|
$ |
450.0 |
|
|
$ |
120.0 |
|
|
$ |
165.0 |
|
|
$ |
165.0 |
|
|
$ |
|
|
Interest on Convertible Securities |
|
|
36.2 |
|
|
|
11.5 |
|
|
|
16.9 |
|
|
|
7.8 |
|
|
|
|
|
Employment Agreements |
|
|
5.2 |
|
|
|
2.8 |
|
|
|
2.4 |
|
|
|
|
|
|
|
|
|
Operating Leases |
|
|
15.2 |
|
|
|
2.9 |
|
|
|
5.3 |
|
|
|
2.7 |
|
|
|
4.3 |
|
Purchase Obligations |
|
|
1.0 |
|
|
|
1.0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Warranty Obligations |
|
|
1.3 |
|
|
|
1.1 |
|
|
|
0.2 |
|
|
|
|
|
|
|
|
|
Pension Contributions |
|
|
0.3 |
|
|
|
0.3 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
509.2 |
|
|
$ |
139.6 |
|
|
$ |
189.8 |
|
|
$ |
175.5 |
|
|
$ |
4.3 |
|
In addition, under other agreements we are required to make payments based on sales levels of
certain products. Furthermore, as noted in Note 1 to the Financial Statements, we have identified
uncertain tax positions, which, if challenged, could result in additional payments of taxes plus
penalties and interest.
The above table does not include contingent interest that we may be obligated to pay on our
contingent convertible subordinated notes due in March 2008. See Note 6 to the unaudited condensed
consolidated financial statements.
OTHER MATTERS
Critical Accounting Estimates
The critical accounting estimates included in our Annual Report on Form 10-K for the fiscal
year ended December 31, 2006 have not materially changed, except for the assessment of uncertain
tax positions in accordance with FIN 48.
Recently Adopted Accounting Standard
Effective January 1, 2007, the Company adopted Financial Accounting Standards Board
Interpretation No. 48 Accounting for Uncertainty in Income Taxes (FIN 48). Refer to Note 1 to
our condensed consolidated financial statements entitled Basis of Presentation for further
details.
Recently Issued Accounting Standards
In September 2006, the FASB issued Statement of Financial Accounting Standards No. 157, Fair
Value Measurements (SFAS 157). SFAS 157 defines fair value, establishes a framework for measuring
fair value in generally accepted accounting principles (GAAP) and expands disclosures about fair
value measurements. SFAS 157 is effective for financial statements issued for fiscal years
beginning after November 15, 2007. We are currently assessing the impact this provision may have on
Integras financial position or results of operations.
In February 2007, the FASB issued Statement of Financial Accounting Standards No. 159, The
Fair Value Option for Financial Assets and Financial Liabilities (SFAS 159). SFAS 159 provides
companies an option to report certain financial assets and liabilities at fair value. The intent of
SFAS 159 is to reduce the complexity in accounting for financial instruments and the volatility in
earnings caused by measuring related assets and liabilities differently. SFAS 159 is effective for
financial statements issued for fiscal years after November 15, 2007. We are evaluating the impact
this new standard will have on Integras financial position and results of operations.
34
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
We are exposed to various market risks, including changes in foreign currency exchange rates
and interest rates that could adversely affect our results of operations and financial condition.
To manage the volatility relating to these typical business exposures, we may enter into various
derivative transactions when appropriate. We do not hold or issue derivative instruments for
trading or other speculative purposes.
Foreign Currency Exchange Rate Risk
A discussion of foreign currency exchange risks is provided under the caption International
Product Revenues and Operations under Managements Discussion and Analysis of Financial Condition
and Results of Operations.
Interest Rate Risk Senior Secured Credit Facility
We are exposed to the risk of interest rate fluctuations on the interest paid under the terms
of our $300 million senior secured credit facility. At the Companys option, loans under this
facility will bear interest either at a rate equal to LIBOR plus an effective applicable margin or
at a base rate, which is defined as the higher of the Federal Funds Rate plus 1/2 of 1% or the rate
of interest announced publicly by the Administrative Agent as its prime rate. A hypothetical 100
basis point movement in interest rates applicable to this credit facility could increase or
decrease interest expense by up to approximately $3,000,000 on an annual basis depending on the
amount outstanding. However, we had no borrowings under the credit facility as of September 30,
2007.
35
ITEM 4. CONTROLS AND PROCEDURES
Evaluation of Disclosure Controls and Procedures
We maintain disclosure controls and procedures that are designed to ensure that information
required to be disclosed in our Exchange Act reports is recorded, processed, summarized and
reported within the time periods specified in the Securities and Exchange Commissions rules and
forms and that such information is accumulated and communicated to our management, including our
principal executive officer and principal financial officer, as appropriate, to allow for timely
decisions regarding required disclosure. Disclosure controls and procedures, no matter how well
designed and operated, can provide only reasonable assurance of achieving the desired control
objectives, and management is required to apply its judgment in evaluating the cost-benefit
relationship of possible controls and procedures. Management has designed our disclosure controls
and procedures to provide reasonable assurance of achieving the desired control objectives.
In connection with the preparation of this Quarterly Report on Form 10-Q, our management
carried out an evaluation, under the supervision and with the participation of our management,
including our principal executive officer and principal financial officer, of the effectiveness of
the design and operation of our disclosure controls and procedures, as such term is defined under
Rule 13a-15(e) under the Exchange Act. Based upon this evaluation, our principal executive officer
and principal financial officer concluded that our disclosure controls and procedures were not
effective at a reasonable assurance level as of September 30, 2007 because of the material weakness
discussed below. Notwithstanding the material weakness discussed below, our management has
concluded that the condensed consolidated financial statements included in this Quarterly Report on
Form 10-Q fairly present in all material respects our financial condition, results of operations
and cash flows for the periods presented in conformity with generally accepted accounting
principles.
Changes in Internal Control Over Financial Reporting
There were no material changes in our internal control over financial reporting (as defined in
Rules 13a-15(f) and 15d-15(f) under the Exchange Act) that occurred during the quarter ended
September 30, 2007 that have materially affected, or are reasonably likely to materially affect,
our internal control over financial reporting.
Management Action Plan and Progress to Date
A material weakness is a control deficiency, or combination of control deficiencies, that
results in more than a remote likelihood that a material misstatement of the annual or interim
financial statements will not be prevented or detected. In our Form 10-Q for the three months ended
March 31, 2007, management noted it had identified a material weakness in our internal control over
financial reporting with respect to the review and approval of certain account reconciliations,
particularly in the areas of accrued liabilities, income taxes, intercompany, and certain other
asset accounts. Turnover in our finance department was a contributor to the material weakness
noted. Remediation of this weakness had not yet been completed and, therefore, this material
weakness continued to exist as of September 30, 2007.
In response to the material weakness identified as of March 31, 2007, we have taken certain
actions and will continue to take further steps in an attempt to strengthen our control processes
and procedures in order to remediate such material weakness. We will continue to evaluate the
effectiveness of our internal controls and procedures on an ongoing basis and will take further
action as appropriate. These actions include an assessment of intercompany accounts and the
reconciliation process with the assistance of outside consultants. This was helpful not only in
connection with the September 30, 2007 quarterly close, but also identified a number of process
improvements which will be implemented in future monthly and quarterly closes.
We have taken and are taking the following actions to remediate the material weakness
identified above as existing as of September 30, 2007:
|
|
|
Recruit additional accounting and tax professionals who can provide the adequate
experience and knowledge to improve the timeliness and effectiveness of our account
reconciliation and ultimately the
financial reporting processes. We continue to utilize our internal audit group and
outside consultants as needed to assist with executing the preparation and/or reviews of
reconciliations. |
36
|
|
|
Enforce compliance with and revise the processes for intercompany transactions to
allow for easier accounting and monitoring of such transactions and implement
additional procedures to ensure that intercompany invoices are processed and matched on
a more timely basis. |
|
|
|
|
Improve the financial system capabilities and automate transactions which can be
automated. |
The effectiveness of any system of controls and procedures is subject to certain limitations,
and, as a result, there can be no assurance that our controls and procedures will detect all errors
or fraud. A control system, no matter how well conceived and operated, can provide only reasonable,
not absolute, assurance that the objectives of the control system will be attained.
We will continue to develop new policies and procedures as well as educate and train our
financial reporting department regarding our existing policies and procedures in a continual effort
to improve our internal control over financial reporting, and will be taking further actions as
appropriate. We view this as an ongoing effort to which we will devote significant resources.
We believe that the foregoing actions have improved and will continue to improve our internal
control over financial reporting, as well as our disclosure controls and procedures.
37
PART II. OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
Various lawsuits, claims and proceedings are pending or have been settled by the Company. The
most significant of those are described below.
In May 2006, Codman & Shurtleff, Inc., a division of Johnson & Johnson, commenced an action in
the United States District Court for the District of New Jersey for declaratory judgment against
the Company with respect to United States Patent No. 5,997,895 (the 895 Patent) held by the
Company. The Companys patent covers dural repair technology related to the Companys DuraGen®
family of duraplasty products.
The action seeks declaratory relief that Codmans DURAFORM product does not infringe the
Companys patent and that the Companys patent is invalid. Codman does not seek either damages from
the Company or injunctive relief to prevent the Company from selling the DuraGen® Dural Graft
Matrix. The Company has filed a counterclaim against Codman, alleging that Codmans DURAFORM
product infringes the 895 Patent, seeking injunctive relief preventing the sale and use of
DURAFORM, and seeking damages, including treble damages, for past infringement.
In July 1996, the Company sued Merck KGaA, a German corporation, seeking damages for patent
infringement. The patents in question are part of a group of patents granted to The Burnham
Institute and licensed by the Company that are based on the interaction between a family of cell
surface proteins called integrins and the arginine-glycine-aspartic acid peptide sequence found in
many extracellular matrix proteins.
The case has been tried, appealed, returned to the trial court and further appealed. Most
recently, on July 27, 2007 the United States Court of Appeals for the Federal Circuit reversed the
judgment of the United States District Court and held that the evidence did not support the jurys
verdict that Merck KGaA infringed on the Companys patents. In October 2007, the parties entered
into a stipulation that concludes the case upon the Companys payment to Merck of fees relating to
certain expenses of Merck. The disposition of this case does not affect any of the Companys
products or development projects.
In addition to these matters, we are subject to various claims, lawsuits and proceedings in
the ordinary course of our business, including claims by current or former employees, distributors
and competitors and with respect to our products. In the opinion of management, such claims are
either adequately covered by insurance or otherwise indemnified, or are not expected, individually
or in the aggregate, to result in a material adverse effect on our financial condition. However, it
is possible that our results of operations, financial position and cash flows in a particular
period could be materially affected by these contingencies.
Our international operations subject us to customs, import-export and sanctioned country laws.
These laws restrict, and in some cases prohibit, United States companies from directly or
indirectly selling goods, technology or services to people or entities in certain countries. These
laws also prohibit transactions with certain designated persons. In addition, the United States
foreign corrupt practices laws could inhibit our ability to transact business in countries where
companies that are not subject to those laws compete against the Company and engage in practices
that such laws prohibit the Company from engaging in.
Local economic conditions, legal, regulatory or political considerations, the effectiveness of
our sales representatives and distributors, local competition and changes in local medical practice
could also affect our sales to foreign markets. Relationships with customers and effective terms of
sale frequently vary by country, often with longer-term receivables than are typical in the United
States.
The Company accrues for loss contingencies in accordance with SFAS 5; that is, when it is
deemed probable that a loss has been incurred and that loss is estimable. The amounts accrued are
based on the full amount of the estimated loss before considering insurance proceeds, and do not
include an estimate for legal fees expected to be incurred in connection with the loss contingency.
The Company consistently accrues legal fees in connection with loss contingencies as those fees are
incurred by outside counsel as a period cost.
38
ITEM 1A. RISK FACTORS
The Risk Factors included in the Companys Annual Report on Form 10-K for the fiscal year
ended December 31, 2006 (as modified by the subsequent Quarterly Reports on Form 10-Q for the
periods ended March 31, 2007 and June 30, 2007) have not materially changed other than the
modifications to the risks factors as set forth below.
The industry and market segments in which we operate are highly competitive, and we may be unable
to compete effectively with other companies.
In general, there is intense competition among medical device companies. We compete with
established medical technology companies in many of our product areas. Competition also comes from
early-stage companies that have alternative technological solutions for our primary clinical
targets, as well as universities, research institutions and other non-profit entities. Many of our
competitors have access to greater financial, technical, research and development, marketing,
manufacturing, sales, distribution services and other resources than we do. Our competitors may be
more effective at implementing their technologies to develop commercial products. Our competitors
may be able to gain market share by offering lower-cost products or by offering products that enjoy
better reimbursement methodologies from third-party payors, such as Medicare, Medicaid and private
healthcare insurance.
Our competitive position will depend on our ability to achieve market acceptance for our
products, develop new products, implement production and marketing plans, secure regulatory
approval for products under development, obtain and maintain reimbursement under Medicare, Medicaid
and private healthcare insurance and obtain patent protection. We may need to develop new
applications for our products to remain competitive. Technological advances by one or more of our
current or future competitors or their achievement of superior reimbursement from Medicare,
Medicaid and private healthcare insurance could render our present or future products obsolete or
uneconomical. Our future success will depend upon our ability to compete effectively against
current technology as well as to respond effectively to technological advances. Competitive
pressures could adversely affect our profitability. For example, two of our largest competitors
introduced an onlay dural graft matrix during 2004, a large company introduced a duraplasty product
in 2006 and others may be preparing to introduce similar products. Competitors have also been
developing products to compete with our extremity reconstruction implants. The introduction and
market acceptance of such products could reduce the sales, growth in sales and profitability of our
duraplasty products.
Our largest competitors in the neurosurgery markets are the Medtronic Neurosurgery division of
Medtronic, Inc., the Codman division of Johnson & Johnson, the Stryker Craniomaxillofacial division
of Stryker Corporation and the Aesculap division of B. Braun Medical Inc. In addition, many of our
neurosurgery product lines compete with smaller specialized companies or larger companies that do
not otherwise focus on neurosurgery. Our competitors in extremity reconstruction include the DePuy
division of Johnson & Johnson, Synthes, Inc. and Stryker Corporation, as well as other major
orthopedic companies that carry a full line of reconstructive products. We also compete with Wright
Medical Group, Inc. in the orthopedic category. In surgical instruments, we compete with V.
Mueller, a division of Cardinal Healthcare, as well as Aesculap. In addition, we compete with
Codman and many smaller instrument companies in the reusable and disposable specialty instruments
markets. Our private-label products face diverse and broad competition, depending on the market
addressed by the product. In the orthobiologic market we compete with several of the large
orthopedics companies and small to mid-size specialty companies. Finally, in certain cases our
products compete primarily against medical practices that treat a condition without using a device
or any particular product, such as the medical practices that use autograft tissue instead of our
dermal regeneration products, duraplasty products and nerve repair products.
Our future financial results could be adversely impacted by impairments or other charges.
Since we have grown through acquisitions, we had $179.3 million of goodwill as of September
30, 2007. Under Statement of Financial Accounting Standards (SFAS) No. 142, Goodwill and Other
Intangible Assets, we are required to test both goodwill and other indefinite-lived intangible
assets for impairment on an annual basis based upon a fair value approach, rather than amortizing
them over time. We are also required to test goodwill for impairment between annual tests if an
event occurs or circumstances change that would more likely than not reduce
our enterprise fair value below its book value. See Managements Discussion and Analysis of
Financial Condition and Results of Operations Critical Accounting Policies and the Use of
Estimates Goodwill and other Intangible Assets in our Annual Report on Form 10-K for the year
ended December 31, 2006.
39
SFAS No. 144, Accounting for the Impairment or Disposal of Long-Lived Assets requires that
we assess the impairment of our long-lived assets, including definite-lived intangible assets,
whenever events or changes in circumstances indicate that the carrying value may not be recoverable
as measured by the sum of the expected future undiscounted cash flows. As of September 30, 2007, we
had $181.2 million of other intangible assets.
The value of biotechnology and medical device businesses is often volatile, and the
assumptions underlying our estimates made in connection with our assessments under SFAS No. 142 or
144 may change as a result of that volatility or other factors outside of our control and may
result in impairment charges. The amount of any such impairment charges under SFAS No. 142 or 144
could be significant and could have a material adverse effect on our reported financial results for
the period in which the charge is taken and could have an adverse effect on the market price of our
securities, including the notes and the common stock into which they may be converted.
To market our products under development we will first need to obtain regulatory approval. Further,
if we fail to comply with the extensive governmental regulations that affect our business, we could
be subject to penalties and could be precluded from marketing our products.
As a manufacturer and marketer of medical devices, we are subject to extensive regulation by
the Food and Drug Administration (the FDA) of the U.S. Department of Health and Human Services
and other federal governmental agencies and, in some jurisdictions, by state and foreign
governmental authorities. These regulations govern the introduction of new medical devices, the
observance of certain standards with respect to the design, manufacture, testing, labeling,
promotion and sales of the devices, the maintenance of certain records, the ability to track
devices, the reporting of potential product defects, the import and export of devices and other
matters.
Our products under development are subject to FDA approval or clearance prior to marketing for
commercial use. The process of obtaining necessary FDA approvals or clearances can take years and
is expensive and uncertain. Our inability to obtain required regulatory approval on a timely or
acceptable basis could harm our business. Further, approval or clearance may place substantial
restrictions on the indications for which the product may be marketed or to whom it may be
marketed, warnings that may be required to accompany the product or additional restrictions placed
on the sale and/or use of the product. Further studies, including clinical trials and FDA
approvals, may be required to gain approval for the use of a product for clinical indications other
than those for which the product was initially approved or cleared or for significant changes to
the product. These studies could take years to complete and could be expensive, and there is no
guarantee that the results will convince the FDA to approve or clear the additional indication. Any
negative outcome in our clinical trials could adversely impact our ability to compete against
alternative products or technologies, which could impact our sales. In addition, for products with
an approved Pre-Marketing Approval (PMA), the FDA requires annual reports and may require
post-approval surveillance programs to monitor the products safety and effectiveness. Results of
post-approval programs may limit or expand the further marketing of the product.
Another risk of application to the FDA relates to the regulatory classification of new
products or proposed new uses for existing products. In the filing of each application, we make a
judgment about the appropriate form and content of the application. If the FDA disagrees with our
judgment in any particular case and, for example, requires us to file a PMA application rather than
allowing us to market for approved uses while we seek broader approvals or requires extensive
additional clinical data, the time and expense required to obtain the required approval might be
significantly increased or approval might not be granted.
Approved products are subject to continuing FDA requirements relating to quality control and
quality assurance, maintenance of records, reporting of adverse events and product recalls,
documentation, and labeling and promotion of medical devices. For example, our orthobiologics
products, acquired in connection with the IsoTis, Inc. transaction, are subject to FDA regulations
regarding human cells, tissues, and cellular or tissue-based products, which include requirements
for establishment registration and listing, donor eligibility, current good tissue practices,
labeling, adverse-event reporting, and inspection and enforcement.
40
The FDA and foreign regulatory authorities require that our products be manufactured according
to rigorous standards. These and future regulatory requirements could significantly increase our
production or purchasing costs and could even prevent us from making or obtaining our products in
amounts sufficient to meet market demand. If we or a third-party manufacturer change our approved
manufacturing process, the FDA may require a new approval before that process may be used. Failure
to develop our manufacturing capability could mean that, even if we were to develop promising new
products, we might not be able to produce them profitably, as a result of delays and additional
capital investment costs. Manufacturing facilities, both international and domestic, are also
subject to inspections by or under the authority of the FDA. In addition, failure to comply with
applicable regulatory requirements could subject us to enforcement action, including product
seizures, recalls, withdrawal of clearances or approvals, restrictions on or injunctions against
marketing our product or products based on our technology, cessation of operations and civil and
criminal penalties.
We are also subject to the regulatory requirements of countries outside the United States
where we do business. For example, under the European Union Medical Device Directive, all medical
devices must meet the Medical Device Directive standards and receive CE Mark Certification. CE Mark
Certification requires a comprehensive Quality System program, comprehensive technical
documentation and data on the product, which a Notified Body in Europe reviews. In addition, we
must be certified to the ISO 13485:2003 Quality System standards and maintain this certification in
order to market our products in the European Union, Canada and most other countries outside the
United States. As a result of an amendment to Japans Pharmaceutical Affairs Law that went into
effect on April 1, 2005, new regulations and requirements exist for obtaining approval of medical
devices, including new requirements governing the conduct of clinical trials, the manufacturing of
products and the distribution of products in Japan. Significant resources may be needed to comply
with the extensive auditing of and requests for documentation relating to all manufacturing
facilities of our company and our vendors by the Pharmaceutical Medical Device Agency and the
Ministry of Health, Labor and Welfare in Japan to comply with the amendment to the Pharmaceutical
Affairs Law. These new regulations may affect our ability to obtain approvals of new products for
sale in Japan.
Lack of market acceptance for our products or market preference for technologies that compete with
our products could reduce our revenues and profitability.
We cannot be certain that our current products or any other products that we may develop or
market will achieve or maintain market acceptance. Certain of the medical indications that can be
treated by our devices can also be treated by other medical devices or by medical practices that do
not include a device. The medical community widely accepts many alternative treatments, and certain
of these other treatments have a long history of use. For example, the use of autograft tissue is a
well-established means for repairing the dermis, and it competes for acceptance in the market with
the Integra ® Dermal Regeneration Template.
We cannot be certain that our devices and procedures will be able to replace those established
treatments or that either physicians or the medical community in general will accept and utilize
our devices or any other medical products that we may develop. For example, market acceptance of
our bone graft substitutes will depend on our ability to demonstrate that our existing bone graft
substitutes and technologies are an attractive alternative to existing treatment options.
Additionally, if there are negative events in the industry, whether real or perceived, there could
be a negative impact on the industry as a whole. For example, we believe that some in the medical
community have lingering concerns over the risk of disease transmission through the use of natural
bone graft substitutes.
In addition, our future success depends, in part, on our ability to develop additional
products. Even if we determine that a product candidate has medical benefits, the cost of
commercializing that product candidate could be too high to justify development. Competitors could
develop products that are more effective, achieve more favorable reimbursement status from
third-party payors, including Medicare, Medicaid and third-party health insurance, cost less or are
ready for commercial introduction before our products. If we are unable to develop additional
commercially viable products, our future prospects could be adversely affected.
41
Market acceptance of our products depends on many factors, including our ability to convince
prospective collaborators and customers that our technology is an attractive alternative to other
technologies, to manufacture products in sufficient quantities and at acceptable costs, and to
supply and service sufficient quantities of our products directly or through our distribution alliances. In addition, unfavorable
reimbursement methodologies, or adverse determinations of third-party payors, including Medicare,
Medicaid and third-party health insurance, against our products or third-party determinations that
favor a competitors product over ours, could harm acceptance or continued use of our products. The
industry is subject to rapid and continuous change arising from, among other things, consolidation,
technological improvements and the pressure on third-party payors and providers to reduce
healthcare costs. One or more of these factors may vary unpredictably, and such variations could
have a material adverse effect on our competitive position. We may not be able to adjust our
contemplated plan of development to meet changing market demands.
It may be difficult to replace some of our suppliers.
Outside vendors, some of whom are sole-source suppliers, provide key components and raw
materials used in the manufacture of our products. Although we believe that alternative sources for
many of these components and raw materials are available, any supply interruption in a limited or
sole-source component or raw material could harm our ability to manufacture our products until a
new or alternative source of supply is identified and qualified. In addition, an uncorrected defect
or suppliers variation in a component or raw material, either unknown to us or incompatible with
our manufacturing process, could harm our ability to manufacture products. We may not be able to
find a sufficient alternative supplier in a reasonable time period, or on commercially reasonable
terms, if at all, and our ability to produce and supply our products could be impaired. We believe
that these factors are most likely to affect the following products that we manufacture:
|
|
|
our collagen-based products, such as the Integra® Dermal Regeneration Template
and wound dressing products, the DuraGen® family of products, and our Absorbable
Collagen Sponges; |
|
|
|
|
our products made from silicone, such as our neurosurgical shunts and drainage systems
and hemodynamic shunts; and |
|
|
|
|
products which use many different electronic parts from numerous suppliers, such as our
intracranial monitors and catheters. |
In addition, our orthobiologics products, acquired in the IsoTis, Inc. transaction, rely on a
small number of tissue banks accredited by the American Association of Tissue Banks, or AATB, for
the supply of human tissue, a crucial component of our bone graft substitutes. We cannot be
certain that these tissue banks will be able to fulfill our requirements, or that we will be able
to successfully negotiate with other accredited tissue facilities on satisfactory terms.
If we were suddenly unable to purchase products from one or more of these companies, we would
need a significant period of time to qualify a replacement, and the production of any affected
products could be disrupted. While it is our policy to maintain sufficient inventory of components
so that our production will not be significantly disrupted even if a particular component or
material is not available for a period of time, we remain at risk that we will not be able to
qualify new components or materials quickly enough to prevent a disruption if one or more of our
suppliers ceases production of important components or materials.
If any of our manufacturing facilities were damaged and/or our manufacturing or business processes
interrupted, we could experience lost revenues and our business could be seriously harmed.
We manufacture our products in a limited number of facilities. Damage to our manufacturing,
development or research facilities due to fire, natural disaster, power loss, communications
failure, unauthorized entry or other events could cause us to cease development and manufacturing
of some or all of our products. In particular, our San Diego and Irvine, California facilities are
susceptible to earthquake damage, wildfire damage and power losses from electrical shortages as are
other businesses in the Southern California area. Our Anasco, Puerto Rico plant, where we
manufacture collagen, silicone and our private-label products, is vulnerable to hurricane, storm
and wind damage. Although we maintain property damage and business interruption insurance coverage
on these facilities, our insurance might not cover all losses under such circumstances and we may
not be able to renew or obtain such insurance in the future on acceptable terms with adequate
coverage or at reasonable costs.
42
In addition, certain of our surgical instruments have some manufacturing processes performed
in Pakistan, which is subject to political instability and unrest, and we purchase a much smaller
amount of instruments directly from vendors there. Such instability could interrupt our ability to
sell surgical instruments to our customers and could have a material adverse effect on our revenues
and earnings. While we are working to develop providers of these services in other countries, we
cannot guarantee that we will be completely successful in achieving these relationships. Even if we
are successful in establishing these alternative relationships, we cannot guarantee that we will be
able to do so at the same level of costs or that we will be able to pass along additional costs to
our customers.
In addition, we began implementing an enterprise business system in 2004, which we intend to
use in our facilities. This system, the hosting and maintenance of which we outsource, replaces
several systems on which we previously relied and will be implemented in several stages. Currently,
we do not have a comprehensive disaster recovery plan for these functions, but we have adopted
various alternative solutions to help mitigate the risk, including implementing backup equipment,
power and communications. We have outsourced our product distribution function in the United States
and in Europe. A delay or other problem with the enterprise business system or with our outsourced
distribution functions could have a material adverse effect on our operations.
Regulatory oversight of the medical device industry might affect the manner in which we may sell
medical devices.
There are laws and regulations that govern the means by which companies in the healthcare
industry may market their products to healthcare professionals and may compete by discounting the
prices of their products, including for example, the federal Anti-Kickback Statute, the federal
False Claims Act, the federal Health Insurance Portability and Accountability Act of 1996, and
state law equivalents to these federal laws that are meant to protect against fraud and abuse.
Violations of these laws are punishable by criminal and civil sanctions, including, in some
instances civil and criminal penalties, damages, fines, exclusion from participation in federal and
state healthcare programs, including Medicare and Medicaid, and the curtailment of restructuring of
operations. Although we exercise care in structuring our sales and marketing practices and
customer discount arrangements to comply with those laws and regulations, we cannot assure you
that:
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government officials charged with responsibility for enforcing those laws will not assert
that our sales and marketing practices or customer discount arrangements are in violation of
those laws or regulations; or |
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government regulators or courts will interpret those laws or regulations in a manner
consistent with our interpretation. |
In January 2004, ADVAMED, the principal U.S. trade association for the medical device
industry, put in place a model code of conduct that sets forth standards by which its members
should abide in the promotion of their products. We have in place policies and procedures for
compliance that we believe are at least as stringent as those set forth in the ADVAMED Code, and we
provide routine training to our sales and marketing personnel on our policies regarding sales and
marketing practices. Nevertheless, the sales and marketing practices of our industry have been the
subject of increased scrutiny from government agencies, and we believe that this trend will
continue. For example, proposed legislation would require detailed disclosure of gifts made to
health care professionals.
We are subject to regulatory requirements relating to the use of hazardous substances which may
impose significant compliance costs on us.
Our research, development and manufacturing processes involve the controlled use of certain
hazardous materials. We are subject to federal, state and local laws and regulations governing the
use, manufacture, storage, handling and disposal of these materials and certain waste products. For
example, our allograft bone tissue processing in both the United States and Europe may generate
waste materials, which in the United State, are classified as medical waste under regulations
promulgated by the U.S. Environmental Protection Agency and various state and local environmental
regulations. Although we believe that our safety procedures for handling and disposing of these
materials comply with the standards prescribed by the applicable laws and regulations, the risk of
accidental contamination or injury from these materials cannot be eliminated. In the event of such
an accident, we could be held liable for any damages that result and any related liability could
exceed the limits or fall outside the coverage of our insurance and could exceed our resources. We may not be able to maintain
insurance on acceptable terms or at all.
43
We had a material weakness in our internal control over financial reporting and cannot assure you
that additional material weaknesses will not be identified in the future.
Management identified a material weakness in our internal control over the review and approval
of certain account reconciliations that existed during the quarter ended March 31, 2007. Turnover
in our finance department was a contributor to the material weakness noted. Remediation of this
weakness had not yet been completed, and therefore this material weakness continued to exist as of
September 30, 2007.
While we aim to work diligently to ensure a robust accounting system that is devoid of
significant deficiencies and material weaknesses, given the growth of our business through
acquisitions and the complexity of the accounting rules, we may, in the future, identify additional
significant deficiencies or material weaknesses in our disclosure controls and procedures and
internal control over financial reporting. Any failure to maintain or implement required new or
improved controls, or any difficulties we encounter in their implementation, could result in
additional significant deficiencies or material weaknesses, cause us to fail to meet our periodic
reporting obligations or result in material misstatements in our financial statements. Any such
failure could also adversely affect the results of periodic management evaluations and annual
auditor attestation reports regarding the effectiveness of our internal control over financial
reporting required under Section 404 of the Sarbanes-Oxley Act of 2002 and the rules promulgated
under Section 404. The existence of a material weakness could result in errors in our financial
statements that could result in a restatement of financial statements, cause us to fail to meet our
reporting obligations and cause investors to lose confidence in our reported financial information,
leading to a decline in our stock price.
The accounting method for our convertible debt securities may be subject to change.
In July 2007, the Financial Accounting Standards Board (FASB) voted unanimously to approve
the preparation of a FASB Staff Position (FSP) on the accounting for convertible debt securities
that requires or permits settlement in cash either in whole or in part upon conversion (cash
settled convertible debt securities), which includes our convertible debt securities. As publicly
discussed by the FASB to date, the proposed FSP would require the proceeds from the issuance of
such convertible debt instruments to be allocated between a liability component and an equity
component. The resulting debt discount would be amortized over the period the convertible debt is
expected to be outstanding as additional non-cash interest expense. The change in accounting
treatment would be effective for fiscal years beginning after December 15, 2007, and applied
retrospectively to prior periods. If adopted and issued as publicly discussed, this FSP would
change the accounting treatment for our 2.5% Contingent Convertible Subordinated Notes due in 2008
and our 2.375% and 2.75% Senior Convertible Notes due in 2010 and 2012, respectively. The impact of
this new accounting treatment would be significant and result in an increase to non-cash interest
expense beginning in fiscal year 2008 for financial statements covering past and future periods.
44
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
The following table summarizes our repurchases of our common stock during the quarter ended
September 30, 2007.
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Total Number |
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Approximate |
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of Shares |
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Dollar Value of |
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Purchased as |
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Shares that May |
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Total Number |
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Average |
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Part of Publicly |
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Yet be Purchased |
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of Shares |
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Price Paid |
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Announced |
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Under the |
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Period |
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Purchased |
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per Share |
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Program |
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Program(1) |
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July 1, 2007 July 31, 2007 |
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$ |
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$ |
75,000,000 |
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August 1, 2007 August 31, 2007 |
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$ |
75,000,000 |
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September 1, 2007 September 30, 2007 |
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$ |
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$ |
75,000,000 |
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Total |
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$ |
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$ |
75,000,000 |
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(1) |
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On May 17, 2007, the Companys Board of Directors authorized the Company to repurchase shares
of its common stock for an aggregate purchase price not to exceed $75 million through December 31,
2007. On October 30, 2007, the Companys Board of Directors terminated the repurchase authorization
it adopted in May 2007 and authorized the Company to repurchase shares of its common stock for an
aggregate purchase price not to exceed $75 million through December 31, 2008. Shares may be
repurchased either in the open market or in privately negotiated transactions. See Note 9 to the
unaudited condensed consolidated financial statements. |
45
ITEM 6. EXHIBITS
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4.1 |
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Fourth Amendment, dated as of September 5, 2007, among Integra
LifeSciences Holdings Corporation, the lenders party thereto, Bank
of America, N.A., as Administrative Agent, Swing Line Lender and L/C
Issuer, Citibank, N.A., successor by merger to Citibank, FSB, as
Syndication Agent and JPMorgan Chase Bank, N.A., Deutsche Bank Trust
Company Americas and Royal Bank of Canada, as Co-Documentation
Agents (Incorporated by reference to Exhibit 4.1 to the Companys
Current Report on Form 8-K filed on September 6, 2007) |
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10.1 |
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Agreement and Plan of Merger, dated as of August 6, 2007, among
Integra LifeSciences Holdings Corporation, Ice Mergercorp, Inc and
IsoTis, Inc. (Incorporated by reference to Exhibit 10.1 to the
Companys Current Report on Form 8-K filed on August 7, 2007) |
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10.2 |
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Separation Agreement, dated as of September 6, 2007, by and among
Integra LifeSciences Holdings Corporation and Maureen B. Bellantoni
(Incorporated by reference to Exhibit 10.1 to the Companys Current
Report on Form 8-K filed on September 7, 2007 |
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*31.1 |
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Certification of Principal Executive Officer Pursuant to Section 302
of the Sarbanes-Oxley Act of 2002 |
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*31.2 |
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Certification of Principal Financial Officer Pursuant to Section 302
of the Sarbanes-Oxley Act of 2002 |
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*32.1 |
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Certification of Principal Executive Officer Pursuant to Section 906
of the Sarbanes-Oxley Act of 2002 |
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*32.2 |
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Certification of Principal Financial Officer Pursuant to Section 906
of the Sarbanes-Oxley Act of 2002 |
46
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.
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INTEGRA LIFESCIENCES HOLDINGS CORPORATION
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Date: November 9, 2007 |
/s/ Stuart M. Essig
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Stuart M. Essig |
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President and Chief Executive Officer |
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Date: November 9, 2007 |
/s/ John B. Henneman, III
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John B. Henneman, III |
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Executive Vice President, Chief Administrative Officer
and Acting Chief Financial Officer |
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47
Exhibits
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4.1 |
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Fourth Amendment, dated as of September 5, 2007, among Integra
LifeSciences Holdings Corporation, the lenders party thereto, Bank
of America, N.A., as Administrative Agent, Swing Line Lender and L/C
Issuer, Citibank, N.A., successor by merger to Citibank, FSB, as
Syndication Agent and JPMorgan Chase Bank, N.A., Deutsche Bank Trust
Company Americas and Royal Bank of Canada, as Co-Documentation
Agents (Incorporated by reference to Exhibit 4.1 to the Companys
Current Report on Form 8-K filed on September 6, 2007) |
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10.1 |
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Agreement and Plan of Merger, dated as of August 6, 2007, among
Integra LifeSciences Holdings Corporation, Ice Mergercorp, Inc and
IsoTis, Inc. (Incorporated by reference to Exhibit 10.1 to the
Companys Current Report on Form 8-K filed on August 7, 2007) |
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10.2 |
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Separation Agreement, dated as of September 6, 2007, by and among
Integra LifeSciences Holdings Corporation and Maureen B. Bellantoni
(Incorporated by reference to Exhibit 10.1 to the Companys Current
Report on Form 8-K filed on September 7, 2007) |
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*31.1 |
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Certification of Principal Executive Officer Pursuant to Section 302
of the Sarbanes-Oxley Act of 2002 |
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*31.2 |
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Certification of Principal Financial Officer Pursuant to Section 302
of the Sarbanes-Oxley Act of 2002 |
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*32.1 |
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Certification of Principal Executive Officer Pursuant to Section 906
of the Sarbanes-Oxley Act of 2002 |
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*32.2 |
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Certification of Principal Financial Officer Pursuant to Section 906
of the Sarbanes-Oxley Act of 2002 |
48