e10vq
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q
(Mark One)
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þ |
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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 June 30, 2006
OR
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o |
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT
OF 1934 |
For the transition period from to
COMMISSION FILE NUMBER 001-16789
INVERNESS MEDICAL INNOVATIONS, INC.
(Exact Name Of Registrant As Specified In Its Charter)
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DELAWARE
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04-3565120 |
(State or other jurisdiction of
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(I.R.S. Employer |
incorporation or organization)
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Identification No.) |
51 SAWYER ROAD, SUITE 200
WALTHAM, MASSACHUSETTS 02453
(Address of principal executive offices)
(781) 647-3900
(Registrants Telephone Number, Including Area Code)
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by
Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for
such shorter period that the registrant was required to file such reports), and (2) has been
subject to such filing requirements for the past 90 days.
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 accelerated filer and large accelerated filer in
Rule 12b-2 of the Exchange Act. (Check one):
Large accelerated filer o Accelerated filer þ Non-accelerated filer o
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the
Exchange Act).
Yes o No þ
The number of shares outstanding of the registrants common stock, par value of $0.001 per share,
as of August 4, 2006 was 32,969,939.
INVERNESS MEDICAL INNOVATIONS, INC.
FORM 10-Q
For the Quarterly Period Ended June 30, 2006
This Quarterly Report on Form 10-Q contains forward-looking statements within the meaning of
Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange
Act of 1934, as amended. Readers can identify these statements by forward-looking words such as
may, could, should, would, intend, will, expect, anticipate, believe, estimate,
continue or similar words. There are a number of important factors that could cause actual
results of Inverness Medical Innovations, Inc. and its subsidiaries to differ materially from those
indicated by such forward-looking statements. These factors include, but are not limited to, the
risk factors detailed in Part I, Item 1A, Risk Factors, of our Annual Report on Form 10-K for the
fiscal year ending December 31, 2005 and other risk factors identified herein or from time to time
in our periodic filings with the Securities and Exchange Commission. Readers should carefully
review these factors as well as the Special Statement Regarding Forward-Looking Statements
beginning on page 41, in this Quarterly Report on Form 10-Q and should not place undue reliance on
our forward-looking statements. These forward-looking statements are based on information, plans
and estimates at the date of this report. We undertake no obligation to update any forward-looking
statements to reflect changes in underlying assumptions or factors, new information, future events
or other changes.
Unless the context requires otherwise, references in this Quarterly Report on Form 10-Q to
we, us and our refer to Inverness Medical Innovations, Inc. and its subsidiaries.
TABLE OF CONTENTS
2
PART I FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
INVERNESS MEDICAL INNOVATIONS, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited)
(in thousands, except per share amounts)
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Three Months Ended June 30, |
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Six Months Ended June 30, |
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2006 |
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2005 |
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2006 |
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2005 |
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Net product sales |
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$ |
136,597 |
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$ |
97,773 |
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$ |
259,350 |
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$ |
187,472 |
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License and royalty revenue |
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3,116 |
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4,498 |
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8,184 |
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6,719 |
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Net revenue |
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139,713 |
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102,271 |
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267,534 |
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194,191 |
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Cost of sales |
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91,217 |
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67,558 |
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166,784 |
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127,289 |
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Gross profit |
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48,496 |
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34,713 |
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100,750 |
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66,902 |
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Operating expenses: |
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Research and development (Note 11) |
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13,114 |
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5,360 |
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23,724 |
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12,592 |
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Sales and marketing |
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22,690 |
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17,666 |
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43,512 |
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34,696 |
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General and administrative |
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17,678 |
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16,242 |
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33,516 |
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30,357 |
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Loss on dispositions, net (Note 10) |
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3,191 |
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3,191 |
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Operating (loss) income |
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(8,177 |
) |
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(4,555 |
) |
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(3,193 |
) |
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(10,743 |
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Interest expense, including amortization of original
issue discounts and write-off of deferred financing
costs (Note 12) |
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(6,882 |
) |
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(4,960 |
) |
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(12,603 |
) |
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(9,972 |
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Other income (expense), net |
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5,301 |
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14,872 |
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4,873 |
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19,783 |
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(Loss) income before provision for income taxes |
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(9,758 |
) |
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5,357 |
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(10,923 |
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(932 |
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Provision for income taxes |
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798 |
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2,854 |
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2,263 |
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4,367 |
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Net (loss) income |
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$ |
(10,556 |
) |
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$ |
2,503 |
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$ |
(13,186 |
) |
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$ |
(5,299 |
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Net (loss) income per common share basic (Note 5) |
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$ |
(0.33 |
) |
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$ |
0.11 |
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$ |
(0.42 |
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$ |
(0.24 |
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Net (loss) income per common share diluted (Note 5) |
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$ |
(0.33 |
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$ |
0.10 |
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$ |
(0.42 |
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$ |
(0.24 |
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Weighted average common shares basic (Note 5) |
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32,445 |
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23,127 |
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31,141 |
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22,040 |
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Weighted average common shares diluted (Note 5) |
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32,445 |
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24,627 |
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31,141 |
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22,040 |
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The accompanying notes are an integral part of these consolidated financial statements.
3
INVERNESS MEDICAL INNOVATIONS, INC. AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
(unaudited)
(in thousands, except per share amounts)
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June 30, 2006 |
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December 31, 2005 |
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ASSETS |
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Current assets: |
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Cash and cash equivalents |
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$ |
42,164 |
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$ |
34,270 |
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Accounts receivable, net of allowances of $8,917 at June 30, 2006 and $9,748
at December 31, 2005 |
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91,968 |
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70,476 |
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Inventories |
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76,138 |
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71,209 |
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Deferred tax assets |
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845 |
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844 |
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Prepaid expenses and other current assets |
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18,591 |
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17,534 |
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Total current assets |
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229,706 |
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194,333 |
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Property, plant and equipment, net |
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79,847 |
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72,211 |
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Goodwill |
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388,620 |
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322,210 |
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Other intangible assets with indefinite lives |
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67,437 |
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63,742 |
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Core technology and patents, net |
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64,397 |
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64,050 |
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Other intangible assets, net |
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97,612 |
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60,489 |
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Deferred financing costs, net and other non-current assets |
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11,277 |
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13,013 |
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Other investments |
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9,318 |
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456 |
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Deferred tax assets |
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655 |
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662 |
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Total assets |
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$ |
948,869 |
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$ |
791,166 |
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LIABILITIES AND STOCKHOLDERS EQUITY |
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Current liabilities: |
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Current portion of long-term debt |
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$ |
1,372 |
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$ |
2,367 |
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Current portion of capital lease obligations |
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559 |
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542 |
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Accounts payable |
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50,550 |
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42,155 |
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Accrued expenses and other current liabilities |
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74,853 |
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64,746 |
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Total current liabilities |
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127,334 |
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109,810 |
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Long-term liabilities: |
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Long-term debt, net of current portion |
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274,264 |
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258,617 |
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Capital lease obligations, net of current portion |
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695 |
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978 |
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Deferred tax liabilities |
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20,761 |
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18,881 |
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Other long-term liabilities |
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6,241 |
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5,572 |
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Total long-term liabilities |
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301,961 |
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284,048 |
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Commitments and contingencies (Note 15) |
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Series A redeemable convertible preferred stock, $0.001 par value: |
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Authorized: 2,667 shares
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Issued: 2,527 shares at June 30, 2006 and December 31, 2005 |
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Outstanding: none at June 30, 2006 and December 31, 2005 |
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Stockholders equity: |
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Preferred stock, $0.001 par value |
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Authorized: 2,333 shares
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Issued: none at June 30, 2006 and December 31, 2005 |
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Common stock, $0.001 par value |
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Authorized: 50,000 shares |
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Issued and outstanding: 32,895 at June 30, 2006 and 27,497 shares at
December 31, 2005 |
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33 |
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27 |
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Additional paid-in capital |
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648,376 |
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515,147 |
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Notes receivable from stockholders |
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(14,691 |
) |
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(14,691 |
) |
Accumulated deficit |
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(123,413 |
) |
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(110,227 |
) |
Accumulated other comprehensive income |
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9,269 |
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7,052 |
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Total stockholders equity |
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519,574 |
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397,308 |
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Total liabilities and stockholders equity |
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$ |
948,869 |
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$ |
791,166 |
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The accompanying notes are an integral part of these consolidated financial statements.
4
INVERNESS MEDICAL INNOVATIONS, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited)
(in thousands)
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Six Months Ended June 30, |
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2006 |
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2005 |
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Cash Flows from Operating Activities: |
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Net loss |
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$ |
(13,186 |
) |
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$ |
(5,299 |
) |
Adjustments to reconcile net loss to net cash provided by operating activities: |
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Interest expense related to
amortization and write-off of non-cash
original issue discount and deferred financing costs |
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1,398 |
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|
899 |
|
Non-cash (income) loss related to currency |
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|
(217 |
) |
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|
592 |
|
Non-cash
stock-based compensation expense |
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2,544 |
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|
140 |
|
Depreciation and amortization |
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|
17,972 |
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|
12,685 |
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Deferred income taxes |
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|
1,252 |
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|
1,276 |
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Impairment
of long-lived assets |
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|
9,143 |
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|
2,493 |
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Other non-cash items |
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(1,199 |
) |
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|
(2,491 |
) |
Changes in assets and liabilities, net of acquisitions: |
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Accounts receivable, net |
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(9,295 |
) |
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|
14,407 |
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Inventories |
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914 |
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(2,308 |
) |
Prepaid expenses and other current assets |
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|
992 |
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(5,629 |
) |
Accounts payable |
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4,864 |
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|
364 |
|
Accrued expenses and other current liabilities |
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(12,470 |
) |
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|
11,646 |
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Other non-current liabilities |
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|
644 |
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|
433 |
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Net cash provided by operating activities |
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3,356 |
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|
29,208 |
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Cash Flows from Investing Activities: |
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Purchases of property, plant and equipment |
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(9,202 |
) |
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|
(9,135 |
) |
Proceeds from sale of property, plant and equipment |
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|
2,120 |
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|
151 |
|
Cash paid for acquisitions and transactional costs, net of cash acquired |
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(77,931 |
) |
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|
(74,696 |
) |
Increase
(decrease) in other assets |
|
|
1,109 |
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|
|
(788 |
) |
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Net cash used in investing activities |
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|
(83,904 |
) |
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|
(84,468 |
) |
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|
|
|
|
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Cash Flows from Financing Activities: |
|
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Cash paid for financing costs |
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|
(582 |
) |
|
|
(2,058 |
) |
Proceeds from issuance of common stock, net of issuance costs |
|
|
83,573 |
|
|
|
2,222 |
|
Net proceeds under revolving lines of credit |
|
|
8,817 |
|
|
|
49,172 |
|
Net borrowing (repayments) of notes payable |
|
|
(2,581 |
) |
|
|
20,086 |
|
Principal payments of capital lease obligations |
|
|
(272 |
) |
|
|
(237 |
) |
|
|
|
|
|
|
|
Net cash provided by financing activities |
|
|
88,955 |
|
|
|
69,185 |
|
|
|
|
|
|
|
|
Foreign exchange effect on cash and cash equivalents |
|
|
(513 |
) |
|
|
(1,795 |
) |
|
|
|
|
|
|
|
Net increase in cash and cash equivalents |
|
|
7,894 |
|
|
|
12,130 |
|
Cash and cash equivalents, beginning of period |
|
|
34,270 |
|
|
|
16,756 |
|
|
|
|
|
|
|
|
Cash and cash equivalents, end of period |
|
$ |
42,164 |
|
|
$ |
28,886 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental Disclosure of Non-cash Activities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair value of stock issued for acquisitions and intellectual property |
|
$ |
47,117 |
|
|
$ |
57,962 |
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these consolidated financial statements.
5
INVERNESS MEDICAL INNOVATIONS, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
(1) Basis of Presentation of Financial Information
The accompanying consolidated financial statements of Inverness Medical Innovations, Inc. and
its subsidiaries are unaudited. In the opinion of management, the unaudited consolidated financial
statements contain all adjustments considered normal and recurring and necessary for their fair
presentation. Interim results are not necessarily indicative of results to be expected for the
year. These interim financial statements have been prepared in accordance with accounting
principles generally accepted in the United States of America for interim financial information and
in accordance with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly,
these consolidated financial statements do not include all of the information and footnotes
necessary for a complete presentation of financial position, results of operations and cash flows.
Our audited consolidated financial statements for the year ended December 31, 2005 included
information and footnotes necessary for such presentation and were included in our Annual Report on
Form 10-K filed with the Securities and Exchange Commission on March 15, 2006. These unaudited
consolidated financial statements should be read in conjunction with our audited consolidated
financial statements and notes thereto for the year ended December 31, 2005.
(2) Cash and Cash Equivalents
We consider all highly liquid cash investments with original maturities of three months or
less at the date of acquisition to be cash equivalents. At June 30, 2006, our cash equivalents
consisted of money market funds.
(3) Inventories
Inventories are stated at the lower of cost (first in, first out) or market and are comprised
of the following (in thousands):
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|
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June 30, 2006 |
|
|
December 31, 2005 |
|
Raw materials |
|
$ |
29,296 |
|
|
$ |
25,488 |
|
Work-in-process |
|
|
21,945 |
|
|
|
17,812 |
|
Finished goods |
|
|
24,897 |
|
|
|
27,909 |
|
|
|
|
|
|
|
|
|
|
$ |
76,138 |
|
|
$ |
71,209 |
|
|
|
|
|
|
|
|
(4) Stock-Based Compensation
Effective January 1, 2006, we began recording compensation expense associated with stock
options and other forms of equity compensation in accordance with Statement of Financial Accounting
Standards (SFAS) No. 123-R, Share-Based Payment, as interpreted by SEC Staff Accounting Bulletin
No. 107. Prior to January 1, 2006, we accounted for stock options according to the provisions of
Accounting Principles Board (APB) Opinion No. 25, Accounting for Stock Issued to Employees, and
related interpretations, and therefore no related compensation expense was recorded for awards
granted with no intrinsic value. We adopted the modified prospective transition method provided for
under SFAS No. 123-R, and consequently have not retroactively adjusted results from prior periods.
Under this transition method, compensation cost associated with stock options now includes:
(i) amortization related to the remaining unvested portion of all stock option awards granted prior
to January 1, 2006, based on the grant-date fair value estimated in accordance with the original
provisions of SFAS No. 123, and (ii) amortization related to all stock option awards granted
subsequent to January 1, 2006, based on the grant-date fair value estimated in accordance with the
provisions of SFAS 123-R. In addition, we record expense over the offering period in connection
with shares issued under our employee stock purchase plan. The compensation expense for stock-based
compensation awards includes an estimate for forfeitures and is recognized over the expected term
of the options using the straight-line method.
In accordance with SFAS No. 123-R, as of June 30, 2006, our results of operations reflected
compensation expense for new stock options granted and vested under our stock incentive plan and
employee stock purchase plan during the three and six months ended
June 30, 2006 and the unvested portion of
previous stock option grants which vested during the first six months of 2006. Stock-based
compensation expense in the amount of $1.2 million (or $1.1 million net of tax effects) and $2.5
million (or $2.3 million net of tax effects) was reflected in the consolidated statement of
operations for the three and six months ended June 30, 2006, respectively, as follows (in
thousands):
6
INVERNESS MEDICAL INNOVATIONS, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
|
2006 |
|
|
2006 |
|
Cost of sales |
|
$ |
86 |
|
|
$ |
195 |
|
Research and development |
|
|
287 |
|
|
|
557 |
|
Sales and marketing |
|
|
155 |
|
|
|
343 |
|
General and administrative |
|
|
698 |
|
|
|
1,449 |
|
|
|
|
|
|
|
|
|
|
$ |
1,226 |
|
|
$ |
2,544 |
|
|
|
|
|
|
|
|
Prior to our adoption of SFAS No. 123-R, we reported all tax benefits resulting from the
exercise of stock options as operating cash flows in our consolidated statements of cash flows. In
accordance with SFAS No. 123-R, for the three and six months ended June 30, 2006, the presentation
of our cash flows has changed from prior periods to report the excess tax benefits from the
exercise of stock options as financing cash flows. For the three and six months ended June 30,
2006, no excess tax benefits were generated from option exercises.
For stock options granted prior to the adoption of SFAS No. 123-R, if expense for stock-based
compensation had been determined under the fair value method for the three and six months ended
June 30, 2005, our income (loss) per common share would have been adjusted to the following pro
forma amounts (in thousands, except for per share data):
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
|
2005 |
|
|
2005 |
|
Net income (loss) as reported |
|
$ |
2,503 |
|
|
$ |
(5,299 |
) |
Stock-based employee compensation as reported |
|
|
140 |
|
|
|
140 |
|
Pro forma stock-based employee compensation |
|
|
(1,387 |
) |
|
|
(2,973 |
) |
|
|
|
|
|
|
|
Net income (loss) pro forma |
|
$ |
1,256 |
|
|
$ |
(8,132 |
) |
|
|
|
|
|
|
|
Net income (loss) per common share basic: |
|
|
|
|
|
|
|
|
Net income (loss) per common share as reported |
|
$ |
0.11 |
|
|
$ |
(0.24 |
) |
Stock-based employee compensation as reported |
|
|
0.00 |
|
|
|
0.00 |
|
Pro forma stock-based employee compensation |
|
|
(0.06 |
) |
|
|
(0.13 |
) |
|
|
|
|
|
|
|
Net income (loss) per common share pro forma |
|
$ |
0.05 |
|
|
$ |
(0.37 |
) |
|
|
|
|
|
|
|
Net income (loss) per common share diluted: |
|
|
|
|
|
|
|
|
Net income (loss) per common share as reported |
|
$ |
0.10 |
|
|
$ |
(0.24 |
) |
Stock-based employee compensation as reported |
|
|
0.00 |
|
|
|
0.00 |
|
Pro forma stock-based employee compensation |
|
|
(0.05 |
) |
|
|
(0.13 |
) |
|
|
|
|
|
|
|
Net income (loss) per common share pro forma |
|
$ |
0.05 |
|
|
$ |
(0.37 |
) |
|
|
|
|
|
|
|
Our stock option plans provide for grants of options to employees to purchase common stock at
the fair market value of such shares on the grant date of the award. The options vest over a four
year period, beginning on the date of grant, with a graded vesting schedule of 25% at the end of
each of the four years. The fair value of each option grant is estimated on the date of grant
using the Black-Scholes option-pricing method. We use historical data to estimate the expected
price volatility and the expected forfeiture rate. For the three and six months ended June 30,
2006, we have chosen to employ the simplified method of calculating the expected option term, which
averages an awards weighted average vesting period and its contractual term. The contractual term
of our stock option awards is ten years. The risk-free rate is based on the U.S. Treasury yield
curve in effect at the time of grant with a remaining term equal to the expected term of the
option. We have not made any dividend payments nor do we have plans to pay dividends in the
foreseeable future. The following assumptions were used to estimate the fair value of options
granted during the three and six months ended June 30, 2006 and 2005 using the Black-Scholes
option-pricing model:
7
INVERNESS MEDICAL INNOVATIONS, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Six Months Ended |
|
|
June 30, |
|
June 30, |
|
|
2006 |
|
2005 |
|
2006 |
|
2005 |
Stock Options: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Risk-free interest rate |
|
|
4.00 |
% |
|
|
3.78%-4.09 |
% |
|
|
4.00%-4.38 |
% |
|
|
3.58-4.09 |
% |
Expected dividend yield |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Expected life |
|
6.25 years |
|
|
5 years |
|
|
6.25 years |
|
|
5 years |
|
Expected volatility |
|
|
42 |
% |
|
|
45 |
% |
|
|
42 |
% |
|
|
45 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Six Months Ended |
|
|
June 30, |
|
June 30, |
|
|
2006 |
|
2005 |
|
2006 |
|
2005 |
Employee Stock Purchase Plan: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Risk-free interest rate |
|
|
4.55 |
% |
|
|
3.71 |
% |
|
|
4.55 |
% |
|
|
3.71 |
% |
Expected dividend yield |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Expected life |
|
182 days |
|
|
182 days |
|
|
182 days |
|
|
182 days |
|
Expected volatility |
|
|
38.98 |
% |
|
|
38.15 |
% |
|
|
33.19 |
% |
|
|
36.92 |
% |
A summary of the stock option activity for the six months ended June 30, 2006 is as:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
|
|
|
|
|
|
Average |
|
|
|
|
|
|
|
|
Weighted |
|
Remaining |
|
Aggregate |
|
|
|
|
|
|
Average |
|
Contractual |
|
Intrinsic |
|
|
Options |
|
Exercise Price |
|
Term |
|
Value |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(in thousands) |
Options outstanding, January 1, 2006 |
|
|
3,901,726 |
|
|
$ |
18.82 |
|
|
|
|
|
|
|
|
|
Granted |
|
|
229,500 |
|
|
$ |
26.00 |
|
|
|
|
|
|
|
|
|
Exercised |
|
|
( 228,192 |
) |
|
$ |
15.64 |
|
|
|
|
|
|
|
|
|
Forfeited or expired |
|
|
( 220,190 |
) |
|
$ |
21.17 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options outstanding, June 30, 2006 |
|
|
3,682,844 |
|
|
$ |
19.32 |
|
|
6.68 years |
|
$ |
33,242 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options exercisable, June 30, 2006 |
|
|
2,484,599 |
|
|
$ |
16.93 |
|
|
5.73 years |
|
$ |
28,515 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The weighted average fair value under the Black-Scholes option pricing model of options
granted to employees during the six months ended June 30, 2006 and 2005 were $12.46 and $11.92 per
share, respectively.
As of
June 30, 2006, there was $10.8 million, net of estimated
forfeitures representing the fair value of unvested stock options.
This cost is expected to be recognized over a
weighted-average period of 2.55 years.
8
INVERNESS MEDICAL INNOVATIONS, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
(unaudited)
(5) Net Income (Loss) Per Common Share
The following table sets forth the computation of basic and diluted net income (loss) per
common share (in thousands, except per share amounts):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
|
2006 |
|
|
2005 |
|
|
2006 |
|
|
2005 |
|
Numerator: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) basic and diluted |
|
$ |
(10,556 |
) |
|
$ |
2,503 |
|
|
$ |
(13,186 |
) |
|
$ |
(5,299 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Denominator: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Denominator for basic net income (loss) per
common share weighted average shares |
|
|
32,445 |
|
|
|
23,127 |
|
|
|
31,141 |
|
|
|
22,040 |
|
Effect of dilutive securities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Employee stock options |
|
|
|
|
|
|
1,113 |
|
|
|
|
|
|
|
|
|
Warrants |
|
|
|
|
|
|
283 |
|
|
|
|
|
|
|
|
|
Restricted stock and escrow shares |
|
|
|
|
|
|
104 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dilutive potential common shares |
|
|
|
|
|
|
1,500 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Denominator for dilutive income (loss) per
common share adjusted weighted average
shares |
|
|
32,445 |
|
|
|
24,627 |
|
|
|
31,141 |
|
|
|
22,040 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) per common share basic |
|
$ |
(0.33 |
) |
|
$ |
0.11 |
|
|
$ |
(0.42 |
) |
|
$ |
(0.24 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) per common share diluted |
|
$ |
(0.33 |
) |
|
$ |
0.10 |
|
|
$ |
(0.42 |
) |
|
$ |
(0.24 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
We had potential dilutive securities outstanding on June 30, 2006 consisting of options and
warrants to purchase an aggregate of 4.4 million shares of common stock at a weighted average
exercise price of $18.93 per share. These potential dilutive securities were not included in the
computation of diluted net loss per common share for the three and six months ended June 30, 2006,
because the effect of including the number of such potential dilutive securities would be
antidilutive.
We had the following potential dilutive securities outstanding on June 30, 2005: (a) options
and warrants to purchase an aggregate of 4.7 million shares of common stock at a weighted average
exercise price of $17.79 per share and (b) 104,000 shares of common stock held in escrow. These
potential dilutive securities were not included in the computation of diluted net loss per share
for the six months ended June 30, 2005, because the effect of including the number of such
potential dilutive securities would be antidilutive. Such securities were included in the
computation of diluted net income per common share for the three months ended June 30, 2005.
(6) Comprehensive Income (Loss)
We account for comprehensive income as prescribed by SFAS No. 130, Reporting Comprehensive
Income. In general, comprehensive income (loss) combines net income (loss) and other changes in
equity during the year from non-owner sources. Our accumulated other comprehensive income, which
is a component of shareholders equity, includes primarily foreign currency translation adjustments
and is our only source of equity from non-owners. For the three and six months ended June 30,
2006, we generated a comprehensive loss of $11.4 million and $11.0 million, respectively, and for
the three and six months ended June 30, 2005, we generated a comprehensive loss of $1.1 million and
$11.4 million, respectively.
9
INVERNESS MEDICAL INNOVATIONS, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
(unaudited)
(7) Stockholders Equity
On February 8 and 9, 2006, we sold an aggregate 3,400,000 shares of our common stock at $24.41
per share to funds affiliated with 14 accredited institutional investors in a private placement.
Proceeds from the private placement were approximately $79.3 million, net of issuance costs of $3.7
million. Of this amount, we repaid principal and interest outstanding under our senior credit
facility of $74.1 million, with the remainder of the net proceeds retained for general corporate
purposes.
In connection with the February 2006 private placements of common stock, we registered the
resale of the private placement shares by filing a registration statement on Form S-3 on May 30,
2006.
(8) Business Combinations
All of the acquisitions discussed below resulted in the recognition of goodwill. Acquisitions
are an important part of our growth strategy. When we acquire businesses, we seek to complement
existing products and services, enhance or expand our product lines and/or expand our customer
base. We determine what we are willing to pay for each acquisition partially based on our
expectation that we can cost effectively integrate the products and services of the acquired
companies into our existing infrastructure. In addition, we utilize the existing infrastructure of
the acquired companies to cost effectively introduce our products to new geographic areas. All of
these factors contributed to the acquisition prices of the acquired
businesses discussed below that were in excess of the fair value of net assets acquired and the resultant goodwill.
Acquisitions
(a) Acquisition of Innovacon and the ABON Facility
On May 15, 2006, we acquired a newly-constructed manufacturing facility in Hangzhou, China
(ABON) pursuant to the terms of our acquisition agreement with ACON Laboratories, Inc. and its
affiliates. In connection with the acquisition of the new facility, we acquired ABON BioPharm
(Hangzhou) Co., Ltd (ABON), the direct owner of the new factory and now our subsidiary. The
preliminary aggregate purchase price was approximately $20.4 million which consisted of $8.8
million in cash and 417,446 shares of our common stock with an aggregate fair value of $11.6
million. The fair value of our common stock was determined based on the average market price of our
common stock pursuant to Emerging Issues Task Force (EITF) Issue No. 99-12, Determination of the
Measurement Date for the Market Price of Acquirer Securities Issued in a Purchase Business
Combination. In addition, pursuant to the acquisition agreement, we made an additional payment of
$4.1 million in cash as a result of the amount of cash acquired, net of indebtedness assumed.
On March 31, 2006, we acquired the assets of ACON Laboratories business of researching,
developing, manufacturing, marketing and selling lateral flow immunoassay and directly-related
products in the United States, Canada, Europe (excluding Russia, the former Soviet Republics that
are not part of the European Union, Spain, Portugal and Turkey), Israel, Australia, Japan and New
Zealand (Innovacon). The preliminary aggregate purchase price was approximately $91.2 million
which consisted of $55.1 million in cash, 711,676 shares of our common stock with an aggregate fair
value of $19.7 million, $6.4 million in estimated direct acquisition costs and an additional
liability of $10.0 million payable to the sellers on the deferred payment date, pursuant to the
purchase agreement. The fair value of our common stock was determined based on the average market
price of our common stock pursuant to EITF Issue No. 99-12. In addition to the amounts described
above, we will be required to make additional payments of approximately $71.2 million upon the
completion of the permitting, validation and obtainment of operational capacity of the ABON
facility and regulatory clearance in Spain and Portugal. $20 million of the remaining
payments will be made through the issuance of our common stock, with the balance payable in cash.
The timing and amount of any such payments is contingent upon the successful completion of various
milestones, as defined in the acquisition agreement, and certain regulatory approvals.
10
INVERNESS MEDICAL INNOVATIONS, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
(unaudited)
The aggregate purchase price, which includes both the March 31, 2006 and May 15, 2006 closings
discussed above, was preliminarily allocated to the assets acquired and liabilities assumed at the
date of acquisition as follows (in thousands):
|
|
|
|
|
Cash |
|
$ |
8,403 |
|
Accounts receivable |
|
|
10,373 |
|
Inventories |
|
|
4,510 |
|
Property, plant and equipment, net |
|
|
10,274 |
|
Goodwill |
|
|
53,391 |
|
Trademarks |
|
|
5,000 |
|
Customer relationships |
|
|
30,000 |
|
Supply agreements |
|
|
5,000 |
|
Other assets |
|
|
1,369 |
|
Accounts payable and accrued expenses |
|
|
(4,550 |
) |
Long-term debt |
|
|
(8,125 |
) |
|
|
|
|
|
|
$ |
115,645 |
|
|
|
|
|
The above values for the assets acquired and liabilities assumed are based on preliminary
management estimates due to the timing of the acquisition. Final purchase price allocation may
differ from the above. Management is also in the process of determining the useful lives of the
core technology and intangible assets, as listed above.
The acquisition of Innovacon and ABON are accounted for as purchases under SFAS No. 141.
Accordingly, the operating results of Innovacon and ABON will be included in our consolidated
financial statements from the acquisition date as part of our consumer and professional diagnostic
products reporting units and business segments. Goodwill generated from this acquisition is not
deductible for tax purposes.
(b) Acquisition of CLONDIAG
On February 28, 2006, we acquired 67.45% of CLONDIAG chip technologies GmbH (CLONDIAG), a
privately-held company located in Jena in Germany which has developed a multiplexing technology for
nucleic acid and immunoassay-based diagnostics. Pursuant to the
acquisition agreement, we are
required to purchase the remaining 32.55% on or before August 31, 2006. The initial aggregate
purchase price was $22.7 million, which consisted of $11.8 million in cash, 218,502
shares of our
common stock with an aggregate fair value of $5.8 million and a $5.1 million payable to acquire the
remaining 32.55% stock ownership. In the event that the value of the shares issued in connection
with the acquisition is less than 4.87 million on December 29, 2006, we will be required to pay
the sellers additional cash in the amount of the shortfall. The fair value of our common stock
issued was determined pursuant to EITF Issue No. 99-12. Additionally, pursuant to the terms of the
acquisition agreement, we have an obligation to settle existing employee bonus arrangements with
the CLONDIAG employees totaling 1.1 million ($1.3 million). In connection with this obligation,
we issued 24,896 shares of our common stock with a fair value of $0.7 million to the employees of
CLONDIAG and a cash payment of $0.5 million. As of June 30, 2006, our remaining obligation was $0.1
million. This obligation increased our aggregate purchase price to $24.0 million as of June 30,
2006 and resulted in additional goodwill.
11
INVERNESS MEDICAL INNOVATIONS, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
(unaudited)
The terms of the acquisition agreement also provide for contingent consideration totaling
approximately $8.9 million
consisting of 224,316 shares of our common stock and approximately $3.0 million of cash or stock,
in the event that four specified products are developed on CLONDIAGs platform technology during
the three years following the acquisition date. This contingent consideration will be accounted for
as an increase in the aggregate purchase price, if and when the resolution of the contingency
occurs.
The aggregate purchase price was preliminarily allocated to the assets acquired and
liabilities assumed at the date of acquisition as follows (in thousands):
|
|
|
|
|
Cash and cash equivalents |
|
$ |
270 |
|
Accounts receivable |
|
|
295 |
|
Inventories |
|
|
90 |
|
Prepaid expenses and other current assets |
|
|
390 |
|
Property, plant and equipment |
|
|
1,774 |
|
Goodwill |
|
|
22,518 |
|
Other assets |
|
|
20 |
|
Accounts payable and accrued expenses |
|
|
(1,317 |
) |
|
|
|
|
|
|
$ |
24,040 |
|
|
|
|
|
The
above values for the assets acquired and liabilities assumed are based on preliminary
management estimates due to the timing of the acquisition. Final purchase price allocation may
differ from the above values and will include an evaluation of whether certain in-process research
and development projects have yet reached technical feasibility. The value of projects which have
not yet reached technical feasibility, if any, will be expensed as in-process research and
development when quantified.
The
acquisition of CLONDIAG is accounted for as a purchase under SFAS No. 141. Accordingly,
the operating expenses of CLONDIAG, which consist principally of research and development
activities, have been included in the accompanying consolidated financial statements since the
acquisition date as part of our corporate and other business segment. Goodwill generated from this
acquisition is not deductible for tax purposes.
(c) Minority Interest
On May 17, 2006, we acquired 49% of TechLab, Inc. (TechLab), a privately-held developer,
manufacturer and distributor of rapid non-invasive intestinal diagnostics tests in the areas of
intestinal inflammation, antibiotic associated diarrhea and parasitology. The aggregate purchase
price was $8.8 million which consisted of 303,417 shares of our common stock with an aggregate fair
value of $8.6 million and $0.2 million in estimated direct acquisition costs. The fair value of our
common stock was determined based on the average market price of our common stock pursuant to EITF
Issue No. 99-12. We account for our 49% investment in TechLab under the equity method of
accounting, in accordance with APB Opinion No. 18, The Equity Method of Accounting for Investments
in Common Stock. For the three months ended June 30, 2006, we recorded $0.1 million in other
income, which represented our minority share of TechLabs profit for the period.
(d) Pro Forma Financial Information
The following table presents selected unaudited financial information of our company,
including Binax, Inc. (Binax), Ischemia Technologies, Inc. (Ischemia), the
Determine/DainaScreen assets of Abbott Laboratories rapid diagnostic business (the Determine
business), Thermo BioStar, Inc. (BioStar), Innogenetics Diagnostica Y Terapeutica, S.A.U.
(IDT) and Innovacon as if the acquisitions of these entities had occurred on January 1, 2005. Pro
forma results exclude adjustments for Advanced Clinical Systems Pty Ltd (ACS), CLONDIAG and ABON
as these acquisitions did not materially affect our results of operations. The pro forma results
are derived from the historical financial results of the acquired businesses for all periods
presented and are not necessarily indicative of the results that would have occurred had the
acquisitions been consummated on January 1, 2005.
12
INVERNESS MEDICAL INNOVATIONS, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Six Months Ended |
|
|
June 30, |
|
June 30, |
|
|
2006 |
|
2005 |
|
2006 |
|
2005 |
|
|
(in thousands, except for share amounts) |
|
(in thousands, except for share amounts) |
Pro forma net revenue |
|
$ |
139,713 |
|
|
$ |
131,236 |
|
|
$ |
280,981 |
|
|
$ |
263,106 |
|
Pro forma
net (loss) income |
|
$ |
(10,556 |
) |
|
$ |
7,055 |
|
|
$ |
(10,393 |
) |
|
$ |
5,235 |
|
Pro forma
net (loss) income per
common share basic and
diluted (1) |
|
$ |
(0.33 |
) |
|
$ |
0.22 |
|
|
$ |
(0.33 |
) |
|
$ |
0.17 |
|
|
|
|
(1) |
|
Net loss per common share amounts are computed as described in Note 5. |
(e) Restructuring Plans of Acquisitions
In connection with our acquisitions of BioStar, Ischemia, Ostex International, Inc. (Ostex),
IVC Industries, Inc. (now operating as Inverness Medical Nutritionals
Group or IMN) and certain
entities, businesses and intellectual property of Unilever Plc (the Unipath business), we
recorded restructuring costs as part of the respective aggregate purchase prices in accordance with
EITF Issue No. 95-3, Recognition of Liabilities in Connection with a Purchase Business Combination.
The following table sets forth the restructuring costs and accrual balances recorded on a cash
basis in connection with the restructuring activities of these acquired businesses (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at |
|
Amounts |
|
|
|
|
|
Balance at |
|
|
December 31, 2005 |
|
Paid |
|
Other (1) |
|
June 30, 2006 |
|
|
|
BioStar |
|
$ |
83 |
|
|
$ |
(55 |
) |
|
$ |
|
|
|
$ |
28 |
|
Ischemia |
|
|
144 |
|
|
|
(71 |
) |
|
|
|
|
|
|
73 |
|
Ostex |
|
|
768 |
|
|
|
(58 |
) |
|
|
|
|
|
|
710 |
|
IMN |
|
|
127 |
|
|
|
(29 |
) |
|
|
|
|
|
|
98 |
|
Unipath business |
|
|
1,307 |
|
|
|
|
|
|
|
65 |
|
|
|
1,372 |
|
|
|
|
Total restructuring costs |
|
$ |
2,429 |
|
|
$ |
(213 |
) |
|
$ |
65 |
|
|
$ |
2,281 |
|
|
|
|
|
|
|
(1) |
|
Represents foreign currency translation adjustment |
During the fourth quarter of 2005, we established a restructuring plan in connection with
our acquisition of BioStar and recorded restructuring costs of $0.5 million, of which $0.4 million
related to impairment of fixed assets and $0.1 million related to severance costs associated with a
headcount reduction. The total number of employees to be involuntarily terminated was nine, of
which all were terminated as of June 30, 2006. Of the costs
recorded during 2005, $28,000 remains unpaid as of June 30, 2006. Although we believe our plan and estimated exit costs are
reasonable, actual spending for exit activities may differ from current estimated exit costs, which
might impact the final aggregate purchase price.
In connection with our acquisition of Ischemia in March 2005, we established a restructuring
plan whereby we exited the current facilities of Ischemia in Denver, Colorado and combined its
activities with our existing manufacturing and distribution facilities during the third quarter of
2005. Total severance costs associated with involuntarily terminated employees were estimated to
be $1.6 million, of which $28,000 remains unpaid as of June 30, 2006. We estimated costs to vacate
the Ischemia facilities to be approximately $135,000, of which $90,000 has been paid as of June 30,
2006. The total number of involuntarily terminated employees was 17, of which all were terminated
as of June 30, 2006.
As a result of our acquisition of Ostex, we established a restructuring plan whereby we exited
the facilities of Ostex in Seattle, Washington, and combined the activities of Ostex with our
existing manufacturing and distribution facilities. The total number of employees to be involuntarily
terminated under the restructuring plan was 38, of which all were terminated as of June 30,
2006. Total severance costs associated with involuntarily terminated employees were $1.6 million,
all of which has been paid as of June 30, 2006. Costs to vacate the Ostex facilities are $0.5
million, of which $0.2 million has been paid as of June 30, 2006. Additionally, the remaining
costs to exit the operations, primarily facilities lease commitments, were $1.9 million, of which
$1.5 million has been paid as of June 30, 2006. Total unpaid exit costs amounted to $0.7 million
as of June 30, 2006.
13
INVERNESS MEDICAL INNOVATIONS, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
(unaudited)
Immediately after the close of the acquisition, we reorganized the business operations of IMN
to improve efficiencies and eliminate redundant activities on a company-wide basis. The
restructuring affected all cost centers within the organization, but most significantly
responsibilities at the sales and executive levels, as such activities were combined with our
existing business operations. Also, as part of the restructuring plan, we relocated one of IMNs
warehouses to a closer proximity of the manufacturing facility to improve efficiency. Of the $1.6
million in total exit costs, which includes severance costs for 47 involuntarily terminated
employees and costs to vacate the warehouse, $1.5 million has been paid as of June 30, 2006.
As a result of the acquisition of the Unipath business from Unilever Plc in 2001, we
reorganized the operations of the Unipath business for purposes of improving efficiencies and
achieving economies of scale on a company-wide basis. Such reorganization affected all major cost
centers at the operations in England. Additionally, most business activities of the U.S. division
were merged into our existing U.S. businesses. Total exit costs, which primarily related to
severance and early retirement obligations for 65 involuntarily terminated employees, were $4.1
million. As of June 30, 2006, $1.4 million, adjusted for foreign exchange effect, in exit costs
remained unpaid.
(9) Restructuring Plans
(a) 2006 Restructuring Plans
On May 22, 2006, we committed to a plan to cease operations at our manufacturing facility in
San Diego, California and to write off certain excess manufacturing equipment at other impacted
facilities. Additionally, on June 7, 2006, we committed to a plan to reorganize the sales and
marketing and customer service functions in certain of our U.S. professional diagnostic companies.
As a result of these restructuring plans, we recorded $9.7 million in restructuring charges during
the three and six months ended June 30, 2006, of which $0.6 million related to severance charges,
$6.4 million related to impairment charges on fixed assets and $2.7 million related to an
impairment charge on an intangible asset related to these plans. The charges for the three and six
months ended June 30, 2006 consisted of $7.0 million charged to cost of sales, $2.6 million charged
to research and development and $0.1 million charged to general and administrative expenses, of
which $2.6 million and $7.1 million was included in our consumer diagnostic and professional
diagnostic products business segment, respectively.
We expect to complete these plans during the first half of 2007. Including the charges
recorded through June 30, 2006, we expect the total restructuring charge related to these plans to
be approximately $13.6 million, with additional charges of $2.8 million
relating to severance and $1.1 million relating to facility exit and closure costs. The total number of employees to be
involuntarily terminated under these plans is 162, of which 2 have been terminated as of June 30,
2006. As of June 30, 2006, all restructuring costs remain unpaid.
(b) 2005 Restructuring Plan
On May 9, 2005, we committed to a plan to cease operations at our facility in Galway, Ireland.
During the three months ended June 30, 2006, we recorded a net restructuring gain of $5.3 million,
of which $0.1 million related to charges for severance, early retirement and outplacement services,
$0.1 million related to facility closing costs and $5.5 million in foreign exchange gains as a
result of recording a cumulative translation adjustment to other income relating primarily to this
plan of termination. During the six months ended June 30, 2006, we recorded a net restructuring
gain of $3.2 million, of which $0.4 million related to charges for severance, early retirement and
outplacement services, $0.1 million related to an impairment charge of fixed assets, $0.6 million
related to facility closing costs and $4.3 million in foreign exchange gains as a result of
recording a cumulative translation adjustment to other income relating primarily to this plan of
termination. The charges for the three and six months ended June 30, 2006 consisted of $0.7
million and $0.7 million, respectively charged to cost of goods sold,
$0.2 million and $0.4 million,
respectively, charged to general and administrative and $5.5 million and $4.3 million,
respectively, in gains recorded to other expense. Of the $0.2 million and $1.1 million included in
operating income for the three and six months ended June 30, 2006, $0.2 million and $0.9 million
was included in our consumer diagnostic products business segment, respectively, and $0.2 million
was included in our professional diagnostic products business segments for the six months ended
June 30, 2006. Additionally, during the three and six months
ended June 30, 2006, we recorded a $1.4 million gain on the sale of
our CDIL facility in Ireland which has been recorded in loss on
dispositions, net in our consolidated statements of operations and is
included in our corporate and other business segment for these periods.
Total restructuring charges since the commitment date were $1.9 million, consisting of $2.6
million related to severance, early retirement and outplacement services, $2.4 million related to
impairment of fixed assets and inventory and $1.2 million
related to facility closing costs, offset
by $4.3 million related to net foreign exchange gains relating primarily to this plan of
termination. Of the total $6.0 million restructuring charges recorded in operating income, $5.7
million and $0.3 million were included in our consumer diagnostic products and professional
diagnostic products business segments, respectively. The plan of
14
INVERNESS MEDICAL INNOVATIONS, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
(unaudited)
termination is substantially complete as of June 30, 2006 and all 113 employees under this plan
have been involuntarily terminated. All costs related to severance, early retirement, outplacement
services and facility closing costs have been substantially paid as of June 30, 2006.
(10) Loss on Dispositions
During the three and six months ended June 30, 2006, we recorded a net loss on dispositions of
$3.2 million. Included in this net loss is a $4.6 million charge associated with managements
decision to dispose of our Scandinavian Micro Biodevices ApS (SMB) research operation, which is
part of our professional diagnostic products and corporate and other business segments, of which
$2.0 million is related to impaired assets, primarily goodwill associated with SMB, and a $2.6
million estimated loss on the sale of SMB. We expect the sale of this operation to be completed in
the third quarter of 2006. The net loss on dispositions also includes an offsetting $1.4 million
gain on the sale of an idle manufacturing facility in Galway, Ireland, as a result of our 2005
restructuring plan. This facility was associated with our consumer diagnostic products business
segment.
(11) Co-Development Arrangement
On February 25, 2005, we entered into a co-development agreement with ITI Scotland Limited
(ITI), whereby ITI agreed to provide us with approximately £30 million over three years to partially fund research and development programs focused on
identifying novel biomarkers and near-patient and home-use tests for cardiovascular and other
diseases (the programs). We agreed to invest £37.5 million in
the programs over three years from the date of the agreement. Through our subsidiary, Stirling
Medical Innovations Limited (Stirling), we established a new research center in Stirling,
Scotland, where we consolidated many of our existing cardiology programs and will ultimately
commercialize products arising from the programs. ITI and Stirling will have exclusive rights to
the developed technology in their respective fields of use. As of June 30, 2006, we had received
approximately $26.8 million in funding from ITI. As qualified expenditures are made under the
co-development arrangement, we recognize the fee earned during the period as a reduction of our
related expenses, subject to certain limitations. For the three and six months ended June 30, 2006,
we recognized $4.5 million and $8.9 million of reimbursements, respectively, of which $4.0 million
and $7.9 million, respectively, offset our research and development spending and $0.5 million and
$1.0 million, respectively, reduced our general, administrative and marketing spending incurred by
Stirling. For the three and six months ended June 30, 2005, we recognized $7.0 million and $9.4
million of reimbursements, respectively, of which $6.9 million and $8.8 million, respectively,
offset our research and development spending and $0.1 million and $0.6 million, respectively,
reduced our general, administrative and marketing spending incurred
by Stirling.
(12) Senior Credit Facility
As of December 31, 2005, $89.0 million of borrowings were outstanding under our senior credit
facility. On February 8 and 9, 2006, we sold an aggregate 3,400,000 shares of our common stock at
$24.41 per share to funds affiliated with 14 accredited institutional investors in a private
placement. Proceeds from the private placement were approximately $79.3 million, net of issuance
costs of $3.7 million. Of this amount, we repaid principal and interest outstanding under our
senior credit facility of $74.1 million, with the remainder of the net proceeds retained for
general corporate purposes. On February 27, 2006, we borrowed $13.0 million under our European
revolving line of credit to fund our acquisition of CLONDIAG.
On March 31, 2006, we entered into an amendment to our third amended and restated credit
agreement. The amendment increased the total amount of credit available to us under the credit
agreement to $155.0 million, from $100.0 million, consisting of a new $45.0 million U.S. term loan,
a $40.0 million U.S. revolving line of credit, reduced from $60.0 million under the credit
agreement prior to the amendment, and a $70.0 million European revolving line of credit, increased
from $40.0 million under the credit agreement prior to the amendment. On March 31, 2006, in
connection with our acquisition of Innovacon, we incurred $58.0 million in indebtedness under the
credit agreement when we received the proceeds of the entire U.S. term loan and drew an additional
$13.0 million under the U.S. revolving line of credit. On May 12, 2006, in the connection with the
acquisition of ABON, we drew $13.0 million under the U.S. revolving line of credit. Our aggregate
indebtedness under the amended credit agreement was $99.0 million as of June 30, 2006.
15
INVERNESS MEDICAL INNOVATIONS, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
(unaudited)
We must repay the U.S. term loan in seven consecutive quarterly installments, beginning on
September 30, 2006, in an amount equal to 0.25% of the aggregate $45.0 million of U.S. term loan
commitments, with the final installment due on March 31, 2008 in the amount of the remaining
principal balance of the U.S. term loan. We may repay any existing or future borrowings under the
revolving lines of credit at any time, but no later than March 31, 2008. We are required to make
mandatory prepayments in various amounts under the credit facilities if we sell assets not in the
ordinary course of business above certain thresholds, issue stock or sell equity securities,
issue subordinated debt or have excess cash flow.
Borrowings under the revolving lines of credit and term loan bear interest at either (i) the
London Interbank Offered Rate (LIBOR), as defined in the agreement, plus applicable margins or,
at our option, (ii) a floating index rate (Index
Rate), as defined in the agreement, plus applicable margins.
Applicable margins, if we choose to use the LIBOR or the Index Rate, can range from 2.75% to 3.75% or
1.50% to 2.50%, respectively, for our revolving lines of credit depending on the quarterly
adjustments that are based on our consolidated financial performance and 4% or 2.75%, respectively,
on our term loan. As of June 30, 2006, the LIBOR and Index Rate applicable under our primary
senior credit facility for the revolving lines of credit were 8.88% and 10.50%, respectively, and
for the U.S. term loan were 9.13% and 10.5%, respectively. For the three and six months ended June
30, 2006, we recorded interest expense, including amortization of deferred financing costs, under
these senior credit facilities in the aggregate amount of $2.7 million and $4.2 million,
respectively. For the three and six months ended June 30, 2005, we recorded interest expense,
including amortization of deferred financing costs, under these senior credit facilities in the
aggregate amount of $0.7 million and $1.4 million, respectively. As of June 30, 2006, accrued
interest related to the senior credit facility amounted to $0.6 million.
Borrowings under the credit facilities remain secured by the stock of certain of our U.S. and
foreign subsidiaries, substantially all of our intellectual property rights, substantially all of
the assets of our businesses in the U.S. and a significant portion of the assets of our
businesses outside the U.S.
(13) Defined Benefit Pension Plan
Our subsidiary in England, Unipath Ltd., has a defined benefit pension plan established for
certain of its employees. The net periodic benefit costs are as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
|
|
2006 |
|
|
2005 |
|
|
2006 |
|
|
2005 |
|
Service cost |
|
$ |
|
|
|
$ |
66 |
|
|
$ |
|
|
|
$ |
134 |
|
Interest cost |
|
|
141 |
|
|
|
149 |
|
|
|
276 |
|
|
|
303 |
|
Expected return on plan assets |
|
|
(117 |
) |
|
|
(88 |
) |
|
|
(229 |
) |
|
|
(179 |
) |
Realized gains |
|
|
80 |
|
|
|
11 |
|
|
|
157 |
|
|
|
22 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net periodic benefit costs |
|
$ |
104 |
|
|
$ |
138 |
|
|
$ |
204 |
|
|
$ |
280 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
16
INVERNESS MEDICAL INNOVATIONS, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
(unaudited)
(14) Financial Information by Segment
Under SFAS No. 131, Disclosures about Segments of an Enterprise and Related Information,
operating segments are defined as components of an enterprise about which separate financial
information is available that is evaluated regularly by the chief operating decision maker, or
decision-making group, in deciding how to allocate resources and in assessing performance. Our
chief operating decision-making group is composed of the chief executive officer and members of
senior management. Our reportable operating segments are Consumer Diagnostic Products, Vitamins
and Nutritional Supplements, Professional Diagnostic Products and Corporate and Other. Included in
the operating loss of Corporate and Other are non-allocable corporate expenditures and expenses
related to our research and development activities in the area of cardiology for the three and six
months ended June 30, 2006, the latter of which amounted to $6.1 million, net of the ITI funding of
$4.0 million (Note 11) and $12.2 million, net of $7.9 million of the ITI funding, respectively, and
$1.9 million, net of the ITI funding of $6.9 million, and $6.3 million, net of $8.8 million of the
ITI funding, respectively, for the three and six months ended June 30, 2005, respectively. Also
included in the operating loss of Corporate and Other for the three and six months ended June 30,
2006 are a net loss on certain dispositions (Note 10) and $2.6 million related to the write-off of
certain cardiology related fixed assets impacted by our restructuring plans (Note 9). Total assets
in the area of cardiology, which are included in Corporate and Other in the tables below, amounted
to $34.8 million at June 30, 2006 and $41.2 million at December 31, 2005.
We
evaluate performance of our operating segments based on net revenue and operating income
(loss). Segment information for the three and six months ended June 30, 2006 and 2005 is as
follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Consumer |
|
Vitamins and |
|
Professional |
|
Corporate |
|
|
|
|
Diagnostic |
|
Nutritional |
|
Diagnostic |
|
and |
|
|
|
|
Products |
|
Supplements |
|
Products |
|
Other |
|
Total |
|
|
|
Three Months Ended June 30, 2006 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net revenue from external customers |
|
$ |
45,532 |
|
|
$ |
22,094 |
|
|
$ |
72,087 |
|
|
$ |
|
|
|
$ |
139,713 |
|
Operating income (loss) |
|
$ |
8,380 |
|
|
$ |
28 |
|
|
$ |
1,138 |
|
|
$ |
(17,723 |
) |
|
$ |
(8,177 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, 2005 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net revenue from external customers |
|
$ |
42,795 |
|
|
$ |
18,918 |
|
|
$ |
40,518 |
|
|
$ |
40 |
|
|
$ |
102,271 |
|
Operating income (loss) |
|
$ |
6,102 |
|
|
$ |
(1,291 |
) |
|
$ |
(3,104 |
) |
|
$ |
(6,262 |
) |
|
$ |
(4,555 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended June 30, 2006 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net revenue from external customers |
|
$ |
88,846 |
|
|
$ |
41,097 |
|
|
$ |
137,591 |
|
|
$ |
|
|
|
$ |
267,534 |
|
Operating income (loss) |
|
$ |
16,860 |
|
|
$ |
(1,049 |
) |
|
$ |
10,554 |
|
|
$ |
(29,558 |
) |
|
$ |
(3,193 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended June 30, 2005 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net revenue from external customers |
|
$ |
86,215 |
|
|
$ |
35,839 |
|
|
$ |
72,028 |
|
|
$ |
109 |
|
|
$ |
194,191 |
|
Operating income (loss) |
|
$ |
13,043 |
|
|
$ |
(3,151 |
) |
|
$ |
(5,590 |
) |
|
$ |
(15,045 |
) |
|
$ |
(10,743 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Assets: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of June 30, 2006 |
|
$ |
306,478 |
|
|
$ |
53,505 |
|
|
$ |
541,800 |
|
|
$ |
47,086 |
|
|
$ |
948,869 |
|
As of December 31, 2005 |
|
$ |
253,063 |
|
|
$ |
52,967 |
|
|
$ |
434,796 |
|
|
$ |
50,340 |
|
|
$ |
791,166 |
|
(15) Material Contingencies and Legal Settlements
Due to the nature of our business, we may from time to time be subject to commercial disputes,
consumer product claims or various other lawsuits arising in the ordinary course of our business,
and we expect this will continue to be the case in the future. These lawsuits generally seek
damages, sometimes in substantial amounts, for commercial or personal injuries allegedly suffered
and can include claims for punitive or other special damages. In addition, we aggressively defend
our patent and other intellectual property rights. This often involves bringing infringement or
other commercial claims against third parties, which can be expensive and can results in
counterclaims against us. We are currently not a party to any material legal proceedings.
17
INVERNESS MEDICAL INNOVATIONS, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
(unaudited)
As of June 30, 2006, we had outstanding material contingent contractual obligations related to
our acquisitions of Binax and CLONDIAG. With respect to Binax, the terms of the acquisition
agreement provide for $11.0 million of contingent cash consideration payable to the Binax
shareholders upon the successful completion of certain new product developments during the five
years following the acquisition. With respect to the acquisition of
CLONDIAG, in the event that the value of the 218,502 shares of our
common stock issued in connection with the acquisition is less than
4.87 million on
December 29, 2006, we will be required to pay the sellers additional
cash in the amount of the shortfall. In addition, the terms of the
acquisition agreement provide for $8.9 million of contingent consideration, consisting of 224,316
shares of our common stock and approximately $3.0 million of cash or stock in the event that four
specified products are developed on CLONDIAGs platform technology during the three years following
the acquisition date.
(16) Recent Accounting Pronouncements
Recently Issued Standards
In
February 2006, the Financial Accounting Standards Board (FASB) issued SFAS No. 155, Accounting for Certain Hybrid Financial
Instruments, which amends SFAS No. 133, Accounting for Derivative Instruments and Hedging
Activities and SFAS No. 140, Accounting for Transfers and Servicing of Financial Assets and
Extinguishments of Liabilities. SFAS No. 155 simplifies the accounting for certain derivatives
embedded in other financial instruments by allowing them to be accounted for as a whole if the
holder elects to account for the whole instrument on a fair value basis. SFAS No. 155 also
clarifies and amends certain other provisions of SFAS No. 133 and SFAS No. 140. SFAS No. 155 is
effective for all financial instruments acquired, issued or subject to a remeasurement event
occurring in fiscal years beginning after September 15, 2006. Earlier adoption is permitted,
provided we have not yet issued financial statements, including for interim periods, for that
fiscal year. We do not expect the adoption of SFAS No. 155 to have a material impact on our
financial position, results of operations or cash flows.
In
March 2006, the FASB issued SFAS No. 156, Accounting for Servicing of Financial Assets an
Amendment of FASB Statement No. 140. SFAS No. 156 requires that all separately recognized
servicing rights be initially measured at fair value, if practicable. In addition, this Statement
permits an entity to choose between two measurement methods (amortization method or fair value
measurement method) for each class of separately recognized servicing assets and liabilities. This
new accounting standard is effective January 1, 2007. The adoption of SFAS No. 156 is not expected
to have an impact on our financial position, results of operations or cash flows.
In
June 2006, the FASB ratified the consensus on EITF Issue
No. 06-03, How Taxes Collected from
Customers and Remitted to Governmental Authorities Should Be Presented in the Income Statement.
The scope of EITF Issue No. 06-03 includes any tax assessed by a governmental authority that is
directly imposed on a revenue-producing transaction between a seller and a customer and may
include, but is not limited to, sales, use, value added, Universal Service Fund (USF)
contributions and some excise taxes. The Task Force affirmed its conclusion that entities should
present these taxes in the income statement on either a gross or a net basis, based on their
accounting policy, which should be disclosed pursuant to APB Opinion No. 22, Disclosure of
Accounting Policies. If such taxes are significant, and are presented on a gross basis, the amounts
of those taxes should be disclosed. The consensus on Issue No. 06-03 will be effective for interim
and annual reporting periods beginning after December 15, 2006. We are currently evaluating the
manner in which we record gross receipts taxes, USF contributions and miscellaneous other taxes and
regulatory cost recovery fees. Should we need to change the manner in which we record gross
receipts, it is not expected that the change would have a material impact on total operating
revenue and expenses and operating income and net income would not be affected.
In June 2006, the FASB issued FASB Interpretation No. (FIN) 48, Accounting for Uncertainty
in Income Taxes an Interpretation of FASB Statement No. 109. FIN 48 clarifies the accounting for
uncertainty in income taxes recognized in an enterprises financial statements in accordance with
FASB Statement No. 109, Accounting for Income Taxes. FIN 48 prescribes a recognition threshold and
measurement of a tax position taken or expected to be taken in a tax return. FIN 48 is effective
for fiscal years beginning after December 15, 2006. We are
currently evaluating the impact of the adoption of FIN 48 on our financial statements, but it is not expected to be material.
18
INVERNESS MEDICAL INNOVATIONS, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
(unaudited)
Recently Adopted Standards
In November 2004, the FASB issued SFAS No. 151, Inventory Costs an Amendment of ARB No. 43,
Chapter 4. SFAS No. 151 clarifies the accounting for abnormal amounts of idle facility expense,
freight, handling costs and wasted materials (spoilage). In addition, this statement requires that
allocation of fixed production overheads to the costs of conversion be based on normal capacity of
production facilities. As required by SFAS No. 151, we adopted this new accounting standard on
January 1, 2006. The adoption of SFAS No. 151 did not have a material impact on our financial
position, results of operations or cash flows.
In December 2004, the FASB issued SFAS No. 123-R, Share-Based Payment, which addresses the
accounting for transactions in which a company receives employee services in exchange for (a)
equity instruments of the company or (b) liabilities that are based on the fair value of the
companys equity instruments or that may be settled by the issuance of such
equity instruments. Under the original guidance of SFAS No. 123-R, we were to adopt the statements
provisions for the interim period beginning after June 15, 2005. However, in April 2005, as a
result of an action by the Securities and Exchange
Commission, companies were allowed to adopt the provisions of SFAS No. 123-R at the beginning of
their fiscal year that begins after June 15, 2005. Consequently, we adopted SFAS No. 123-R on
January 1, 2006. See Note 4 for further discussion.
In May 2005, the FASB issued SFAS No. 154, Accounting Changes and Error Corrections, which
replaces APB Opinion No. 20, Accounting Changes, and SFAS No. 3, Reporting Accounting Changes in
Interim Financial Statements. The statement requires a voluntary change in accounting principle be
applied retrospectively to all prior period financial statements so that those financial statements
are presented as if the current accounting principle had always been applied. APB Opinion No. 20
previously required most voluntary changes in accounting principle to be recognized by including in
net income of the period of change the cumulative effect of changing to the new accounting
principle. In addition, SFAS No. 154 carries forward, without change, the guidance contained in APB
Opinion No. 20 for reporting a correction of an error in previously issued financial statements and
a change in accounting estimate. SFAS No. 154 was effective for accounting changes and corrections
of errors made after January 1, 2006. The adoption of SFAS No. 154 had no impact on our financial
statements.
(17) Related Party Transaction
On
June 20, 2006, we issued 25,000 shares of our common stock as consideration for the
acquisition of all of the capital stock of Innovative Medical Devices
BVBA. The seller of the
capital stock of Innovative Medical Devices BVBA is the spouse of the
Vice President of our Consumer
Diagnostics business unit.
(18) Guarantor Financial Information
We issued $150.0 million in senior subordinated notes (the Bonds) to qualified institutional
buyers in reliance on Rule 144A under the Securities Act of 1933, as amended (the Securities
Act), and outside the United States in compliance with Regulation S of the Securities Act. Our
payment obligations under the Bonds are currently guaranteed by all of our domestic subsidiaries
(the Guarantor Subsidiaries). The guarantee is full and unconditional. Separate financial
statements of the Guarantor Subsidiaries are not presented because we have determined that they
would not be material to investors in the Bonds. The following supplemental financial information
sets forth, on a consolidating basis, the statements of operations and cash flows for the three and
six months ended June 30, 2006 and 2005 and the balance sheets as of June 30, 2006 and December 31,
2005 for our company (the Issuer), the Guarantor Subsidiaries and our other subsidiaries (the
Non-Guarantor Subsidiaries). The supplemental financial information reflects our investments and
the Guarantor Subsidiaries investments in the Guarantor and Non-Guarantor Subsidiaries using the
equity method of accounting.
We have extensive transactions and relationships between various members of our consolidated
group. These transactions and relationships include intercompany pricing agreements, intellectual
property royalty agreements, and general and administrative and research and development cost
sharing agreements. Because of these relationships, it is possible that the terms of these
transactions are not the same as those that would result from transactions among unrelated parties.
19
INVERNESS MEDICAL INNOVATIONS, INC. AND SUBSIDIARIES
CONSOLIDATING STATEMENT OF OPERATIONS
For the Three Months Ended June 30, 2006
(unaudited)
(in thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Guarantor |
|
|
Non-Guarantor |
|
|
|
|
|
|
|
|
|
Issuer |
|
|
Subsidiaries |
|
|
Subsidiaries |
|
|
Eliminations |
|
|
Consolidated |
|
Net product sales |
|
$ |
5,906 |
|
|
$ |
83,422 |
|
|
$ |
63,351 |
|
|
$ |
(16,082 |
) |
|
$ |
136,597 |
|
License and royalty revenue |
|
|
|
|
|
|
82 |
|
|
|
3,034 |
|
|
|
|
|
|
|
3,116 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net revenue |
|
|
5,906 |
|
|
|
83,504 |
|
|
|
66,385 |
|
|
|
(16,082 |
) |
|
|
139,713 |
|
Cost of sales |
|
|
6,942 |
|
|
|
63,626 |
|
|
|
37,008 |
|
|
|
(16,359 |
) |
|
|
91,217 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit |
|
|
(1,036 |
) |
|
|
19,878 |
|
|
|
29,377 |
|
|
|
277 |
|
|
|
48,496 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
415 |
|
|
|
2,017 |
|
|
|
10,682 |
|
|
|
|
|
|
|
13,114 |
|
Sales and marketing |
|
|
1,536 |
|
|
|
11,994 |
|
|
|
9,160 |
|
|
|
|
|
|
|
22,690 |
|
General and administrative |
|
|
5,235 |
|
|
|
5,389 |
|
|
|
7,054 |
|
|
|
|
|
|
|
17,678 |
|
Loss on dispositions, net |
|
|
|
|
|
|
|
|
|
|
3,191 |
|
|
|
|
|
|
|
3,191 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating (loss) income |
|
|
(8,222 |
) |
|
|
478 |
|
|
|
(710 |
) |
|
|
277 |
|
|
|
(8,177 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Equity in earnings of
subsidiaries, net of tax |
|
|
99 |
|
|
|
|
|
|
|
|
|
|
|
(99 |
) |
|
|
|
|
Interest expense, including
amortization of original
issue discounts and
write-off of deferred
financing costs |
|
|
(4,082 |
) |
|
|
(1,827 |
) |
|
|
(6,942 |
) |
|
|
5,969 |
|
|
|
(6,882 |
) |
Other income (expense), net |
|
|
2,221 |
|
|
|
3,857 |
|
|
|
5,276 |
|
|
|
(6,053 |
) |
|
|
5,301 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Loss) income before
provision for (benefit
from) income taxes |
|
|
(9,984 |
) |
|
|
2,508 |
|
|
|
(2,376 |
) |
|
|
94 |
|
|
|
(9,758 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Provision for (benefit from)
income taxes |
|
|
572 |
|
|
|
489 |
|
|
|
(263 |
) |
|
|
|
|
|
|
798 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (loss) income |
|
$ |
(10,556 |
) |
|
$ |
2,019 |
|
|
$ |
(2,113 |
) |
|
$ |
94 |
|
|
$ |
(10,556 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
20
INVERNESS MEDICAL INNOVATIONS, INC. AND SUBSIDIARIES
CONSOLIDATING STATEMENT OF OPERATIONS
For the Six Months Ended June 30, 2006
(unaudited)
(in thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Guarantor |
|
|
Non-Guarantor |
|
|
|
|
|
|
|
|
|
Issuer |
|
|
Subsidiaries |
|
|
Subsidiaries |
|
|
Eliminations |
|
|
Consolidated |
|
Net product sales |
|
$ |
11,793 |
|
|
$ |
156,299 |
|
|
$ |
124,603 |
|
|
$ |
(33,345 |
) |
|
$ |
259,350 |
|
License and royalty revenue |
|
|
|
|
|
|
153 |
|
|
|
8,031 |
|
|
|
|
|
|
|
8,184 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net revenue |
|
|
11,793 |
|
|
|
156,452 |
|
|
|
132,634 |
|
|
|
(33,345 |
) |
|
|
267,534 |
|
Cost of sales |
|
|
13,639 |
|
|
|
114,638 |
|
|
|
71,937 |
|
|
|
(33,430 |
) |
|
|
166,784 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit |
|
|
(1,846 |
) |
|
|
41,814 |
|
|
|
60,697 |
|
|
|
85 |
|
|
|
100,750 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
1,398 |
|
|
|
3,945 |
|
|
|
18,381 |
|
|
|
|
|
|
|
23,724 |
|
Sales and marketing |
|
|
2,838 |
|
|
|
22,078 |
|
|
|
18,596 |
|
|
|
|
|
|
|
43,512 |
|
General and administrative |
|
|
10,387 |
|
|
|
9,265 |
|
|
|
13,864 |
|
|
|
|
|
|
|
33,516 |
|
Loss on dispositions, net |
|
|
|
|
|
|
|
|
|
|
3,191 |
|
|
|
|
|
|
|
3,191 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating (loss) income |
|
|
(16,469 |
) |
|
|
6,526 |
|
|
|
6,665 |
|
|
|
85 |
|
|
|
(3,193 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Equity in earnings of
subsidiaries, net of tax |
|
|
7,370 |
|
|
|
|
|
|
|
|
|
|
|
(7,370 |
) |
|
|
|
|
Interest expense, including
amortization of original
issue discounts and
write-off of deferred
financing costs |
|
|
(8,161 |
) |
|
|
(2,623 |
) |
|
|
(9,466 |
) |
|
|
7,647 |
|
|
|
(12,603 |
) |
Other (expense) income, net |
|
|
4,924 |
|
|
|
3,758 |
|
|
|
3,922 |
|
|
|
(7,731 |
) |
|
|
4,873 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Loss) income before
provision for income
taxes |
|
|
(12,336 |
) |
|
|
7,661 |
|
|
|
1,121 |
|
|
|
(7,369 |
) |
|
|
(10,923 |
) |
Provision for income taxes |
|
|
850 |
|
|
|
1,043 |
|
|
|
370 |
|
|
|
|
|
|
|
2,263 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (loss) income |
|
$ |
(13,186 |
) |
|
$ |
6,618 |
|
|
$ |
751 |
|
|
$ |
(7,369 |
) |
|
$ |
(13,186 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
21
INVERNESS MEDICAL INNOVATIONS, INC. AND SUBSIDIARIES
CONSOLIDATING STATEMENT OF OPERATIONS
For the Three Months Ended June 30, 2005
(unaudited)
(in thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Guarantor |
|
|
Non-Guarantor |
|
|
|
|
|
|
|
|
|
Issuer |
|
|
Subsidiaries |
|
|
Subsidiaries |
|
|
Eliminations |
|
|
Consolidated |
|
Net product sales |
|
$ |
6,498 |
|
|
$ |
58,444 |
|
|
$ |
48,736 |
|
|
$ |
(15,905 |
) |
|
$ |
97,773 |
|
License and royalty revenue |
|
|
|
|
|
|
95 |
|
|
|
4,403 |
|
|
|
|
|
|
|
4,498 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net revenue |
|
|
6,498 |
|
|
|
58,539 |
|
|
|
53,139 |
|
|
|
(15,905 |
) |
|
|
102,271 |
|
Cost of sales |
|
|
6,768 |
|
|
|
48,950 |
|
|
|
28,638 |
|
|
|
(16,798 |
) |
|
|
67,558 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit |
|
|
(270 |
) |
|
|
9,589 |
|
|
|
24,501 |
|
|
|
893 |
|
|
|
34,713 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
628 |
|
|
|
1,502 |
|
|
|
3,230 |
|
|
|
|
|
|
|
5,360 |
|
Sales and marketing |
|
|
772 |
|
|
|
8,935 |
|
|
|
7,959 |
|
|
|
|
|
|
|
17,666 |
|
General and administrative |
|
|
3,141 |
|
|
|
5,595 |
|
|
|
7,506 |
|
|
|
|
|
|
|
16,242 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating (loss) income |
|
|
(4,811 |
) |
|
|
(6,443 |
) |
|
|
5,806 |
|
|
|
893 |
|
|
|
(4,555 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Equity in earnings of
subsidiaries, net of tax |
|
|
10,745 |
|
|
|
|
|
|
|
|
|
|
|
(10,745 |
) |
|
|
|
|
Interest expense, including
amortization of original issue discounts and write-off of
deferred financing costs |
|
|
(4,080 |
) |
|
|
(327 |
) |
|
|
(1,505 |
) |
|
|
952 |
|
|
|
(4,960 |
) |
Other income (expense), net |
|
|
512 |
|
|
|
(2,520 |
) |
|
|
17,832 |
|
|
|
(952 |
) |
|
|
14,872 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) before
provision for (benefit
from) income taxes |
|
|
2,366 |
|
|
|
(9,290 |
) |
|
|
22,133 |
|
|
|
(9,852 |
) |
|
|
5,357 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Provision for (benefit from)
income taxes |
|
|
(137 |
) |
|
|
418 |
|
|
|
2,533 |
|
|
|
40 |
|
|
|
2,854 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) |
|
$ |
2,503 |
|
|
$ |
(9,708 |
) |
|
$ |
19,600 |
|
|
$ |
(9,892 |
) |
|
$ |
2,503 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
22
INVERNESS MEDICAL INNOVATIONS, INC. AND SUBSIDIARIES
CONSOLIDATING STATEMENT OF OPERATIONS
For the Six Months Ended June 30, 2005
(unaudited)
(in thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Guarantor |
|
|
Non-Guarantor |
|
|
|
|
|
|
|
|
|
Issuer |
|
|
Subsidiaries |
|
|
Subsidiaries |
|
|
Eliminations |
|
|
Consolidated |
|
Net product sales |
|
$ |
11,976 |
|
|
$ |
109,530 |
|
|
$ |
94,078 |
|
|
$ |
(28,112 |
) |
|
$ |
187,472 |
|
License and royalty revenue |
|
|
|
|
|
|
126 |
|
|
|
6,593 |
|
|
|
|
|
|
|
6,719 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net revenue |
|
|
11,976 |
|
|
|
109,656 |
|
|
|
100,671 |
|
|
|
(28,112 |
) |
|
|
194,191 |
|
Cost of sales |
|
|
12,385 |
|
|
|
91,998 |
|
|
|
53,205 |
|
|
|
(30,299 |
) |
|
|
127,289 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit |
|
|
(409 |
) |
|
|
17,658 |
|
|
|
47,466 |
|
|
|
2,187 |
|
|
|
66,902 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
770 |
|
|
|
2,617 |
|
|
|
9,205 |
|
|
|
|
|
|
|
12,592 |
|
Sales and marketing |
|
|
1,252 |
|
|
|
16,112 |
|
|
|
17,332 |
|
|
|
|
|
|
|
34,696 |
|
General and administrative |
|
|
6,449 |
|
|
|
9,217 |
|
|
|
14,691 |
|
|
|
|
|
|
|
30,357 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating (loss) income |
|
|
(8,880 |
) |
|
|
(10,288 |
) |
|
|
6,238 |
|
|
|
2,187 |
|
|
|
(10,743 |
) |
Equity in earnings of
subsidiaries, net of tax |
|
|
14,653 |
|
|
|
|
|
|
|
|
|
|
|
(14,653 |
) |
|
|
|
|
Interest expense, including
amortization of original
issue discounts and
write-off of deferred
financing costs |
|
|
(8,324 |
) |
|
|
(811 |
) |
|
|
(2,848 |
) |
|
|
2,011 |
|
|
|
(9,972 |
) |
Other income, net |
|
|
(2,563 |
) |
|
|
6,140 |
|
|
|
18,156 |
|
|
|
(1,950 |
) |
|
|
19,783 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Loss) income before
provision for income
taxes |
|
|
(5,114 |
) |
|
|
(4,959 |
) |
|
|
21,546 |
|
|
|
(12,405 |
) |
|
|
(932 |
) |
Provision for income taxes |
|
|
185 |
|
|
|
1,136 |
|
|
|
3,046 |
|
|
|
|
|
|
|
4,367 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (loss) income |
|
$ |
(5,299 |
) |
|
$ |
(6,095 |
) |
|
$ |
18,500 |
|
|
$ |
(12,405 |
) |
|
$ |
(5,299 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
23
INVERNESS MEDICAL INNOVATIONS, INC. AND SUBSIDIARIES
CONSOLIDATING BALANCE SHEET
June 30, 2006
(unaudited)
(in thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Guarantor |
|
|
Non-Guarantor |
|
|
|
|
|
|
|
|
|
Issuer |
|
|
Subsidiaries |
|
|
Subsidiaries |
|
|
Eliminations |
|
|
Consolidated |
|
ASSETS |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current Assets: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
913 |
|
|
$ |
12,366 |
|
|
$ |
28,885 |
|
|
$ |
|
|
|
$ |
42,164 |
|
Accounts receivable, net of
allowances |
|
|
3,042 |
|
|
|
49,336 |
|
|
|
39,590 |
|
|
|
|
|
|
|
91,968 |
|
Inventories |
|
|
6,807 |
|
|
|
41,775 |
|
|
|
33,655 |
|
|
|
(6,099 |
) |
|
|
76,138 |
|
Deferred tax assets |
|
|
|
|
|
|
1 |
|
|
|
844 |
|
|
|
|
|
|
|
845 |
|
Prepaid expenses and other
current assets |
|
|
2,006 |
|
|
|
2,916 |
|
|
|
13,669 |
|
|
|
|
|
|
|
18,591 |
|
Intercompany receivables |
|
|
33,006 |
|
|
|
38,071 |
|
|
|
14,788 |
|
|
|
(85,865 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current assets |
|
|
45,774 |
|
|
|
144,465 |
|
|
|
131,431 |
|
|
|
(91,964 |
) |
|
|
229,706 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Property, plant and
equipment, net |
|
|
2,178 |
|
|
|
27,352 |
|
|
|
50,317 |
|
|
|
|
|
|
|
79,847 |
|
Goodwill |
|
|
114,317 |
|
|
|
109,116 |
|
|
|
165,187 |
|
|
|
|
|
|
|
388,620 |
|
Other intangible assets with
indefinite lives |
|
|
|
|
|
|
21,120 |
|
|
|
46,317 |
|
|
|
|
|
|
|
67,437 |
|
Core technology and patents,
net |
|
|
19,381 |
|
|
|
14,194 |
|
|
|
30,822 |
|
|
|
|
|
|
|
64,397 |
|
Other intangible assets, net |
|
|
37,998 |
|
|
|
33,436 |
|
|
|
26,178 |
|
|
|
|
|
|
|
97,612 |
|
Deferred financing costs,
net, and other non-current
assets |
|
|
5,104 |
|
|
|
1,957 |
|
|
|
4,216 |
|
|
|
|
|
|
|
11,277 |
|
Deferred tax assets |
|
|
256 |
|
|
|
(1 |
) |
|
|
400 |
|
|
|
|
|
|
|
655 |
|
Investment in subsidiaries
and other investments |
|
|
359,499 |
|
|
|
(1,015 |
) |
|
|
103 |
|
|
|
(349,269 |
) |
|
|
9,318 |
|
Intercompany notes receivable |
|
|
164,452 |
|
|
|
68,267 |
|
|
|
(1 |
) |
|
|
(232,718 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets |
|
$ |
748,959 |
|
|
$ |
418,891 |
|
|
$ |
454,970 |
|
|
$ |
(673,951 |
) |
|
$ |
948,869 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS
EQUITY |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current portion of long-term
debt |
|
$ |
|
|
|
$ |
|
|
|
$ |
1,372 |
|
|
$ |
|
|
|
$ |
1,372 |
|
Current portion of capital
lease obligations |
|
|
|
|
|
|
528 |
|
|
|
31 |
|
|
|
|
|
|
|
559 |
|
Accounts payable |
|
|
4,878 |
|
|
|
28,292 |
|
|
|
17,380 |
|
|
|
|
|
|
|
50,550 |
|
Accrued expenses and other
current liabilities |
|
|
22,898 |
|
|
|
18,425 |
|
|
|
33,530 |
|
|
|
|
|
|
|
74,853 |
|
Intercompany payables |
|
|
27,710 |
|
|
|
28,369 |
|
|
|
29,789 |
|
|
|
(85,868 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current liabilities |
|
|
55,486 |
|
|
|
75,614 |
|
|
|
82,102 |
|
|
|
(85,868 |
) |
|
|
127,334 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Long-term liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Long-term debt, net of
current portion |
|
|
169,556 |
|
|
|
71,000 |
|
|
|
33,708 |
|
|
|
|
|
|
|
274,264 |
|
Capital lease obligations,
net of current portion |
|
|
|
|
|
|
641 |
|
|
|
54 |
|
|
|
|
|
|
|
695 |
|
Deferred tax liabilities |
|
|
4,343 |
|
|
|
7,056 |
|
|
|
9,234 |
|
|
|
128 |
|
|
|
20,761 |
|
Other long-term liabilities |
|
|
|
|
|
|
291 |
|
|
|
5,950 |
|
|
|
|
|
|
|
6,241 |
|
Intercompany notes payable |
|
|
|
|
|
|
59,339 |
|
|
|
173,380 |
|
|
|
(232,719 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total long-term liabilities |
|
|
173,899 |
|
|
|
138,327 |
|
|
|
222,326 |
|
|
|
(232,591 |
) |
|
|
301,961 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders equity |
|
|
519,574 |
|
|
|
204,950 |
|
|
|
150,542 |
|
|
|
(355,492 |
) |
|
|
519,574 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities and
stockholders equity |
|
$ |
748,959 |
|
|
$ |
418,891 |
|
|
$ |
454,970 |
|
|
$ |
(673,951 |
) |
|
$ |
948,869 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
24
INVERNESS MEDICAL INNOVATIONS, INC. AND SUBSIDIARIES
CONSOLIDATING BALANCE SHEET
December 31, 2005
(unaudited)
(in thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Guarantor |
|
|
Non-Guarantor |
|
|
|
|
|
|
|
|
|
Issuer |
|
|
Subsidiaries |
|
|
Subsidiaries |
|
|
Eliminations |
|
|
Consolidated |
|
ASSETS |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current Assets: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
1,196 |
|
|
$ |
8,080 |
|
|
$ |
24,994 |
|
|
$ |
|
|
|
$ |
34,270 |
|
Accounts receivable, net of
allowances |
|
|
2,344 |
|
|
|
34,834 |
|
|
|
33,298 |
|
|
|
|
|
|
|
70,476 |
|
Inventories |
|
|
7,518 |
|
|
|
42,794 |
|
|
|
26,997 |
|
|
|
(6,100 |
) |
|
|
71,209 |
|
Deferred tax assets |
|
|
|
|
|
|
|
|
|
|
844 |
|
|
|
|
|
|
|
844 |
|
Prepaid expenses and other
current
assets |
|
|
2,228 |
|
|
|
2,720 |
|
|
|
12,586 |
|
|
|
|
|
|
|
17,534 |
|
Intercompany receivables |
|
|
38,919 |
|
|
|
34,346 |
|
|
|
19,974 |
|
|
|
(93,239 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current assets |
|
|
52,205 |
|
|
|
122,774 |
|
|
|
118,693 |
|
|
|
(99,339 |
) |
|
|
194,333 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Property, plant and equipment,
net |
|
|
2,632 |
|
|
|
31,164 |
|
|
|
38,415 |
|
|
|
|
|
|
|
72,211 |
|
Goodwill |
|
|
72,787 |
|
|
|
109,637 |
|
|
|
139,786 |
|
|
|
|
|
|
|
322,210 |
|
Other intangible assets with
indefinite lives |
|
|
8,700 |
|
|
|
12,420 |
|
|
|
42,622 |
|
|
|
|
|
|
|
63,742 |
|
Core technology and patents, net |
|
|
28,269 |
|
|
|
5,556 |
|
|
|
30,225 |
|
|
|
|
|
|
|
64,050 |
|
Other intangible assets, net |
|
|
20,321 |
|
|
|
18,429 |
|
|
|
21,739 |
|
|
|
|
|
|
|
60,489 |
|
Deferred financing costs, net,
and
other non-current assets |
|
|
6,696 |
|
|
|
2,051 |
|
|
|
4,266 |
|
|
|
|
|
|
|
13,013 |
|
Deferred tax assets |
|
|
|
|
|
|
|
|
|
|
662 |
|
|
|
|
|
|
|
662 |
|
Investment in subsidiaries and
other investments |
|
|
297,607 |
|
|
|
(866 |
) |
|
|
160 |
|
|
|
(296,445 |
) |
|
|
456 |
|
Intercompany notes receivable |
|
|
130,001 |
|
|
|
43,066 |
|
|
|
|
|
|
|
(173,067 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets |
|
$ |
619,218 |
|
|
$ |
344,231 |
|
|
$ |
396,568 |
|
|
$ |
(568,851 |
) |
|
$ |
791,166 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS EQUITY |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current portion of long-term debt |
|
$ |
|
|
|
$ |
|
|
|
$ |
2,367 |
|
|
$ |
|
|
|
$ |
2,367 |
|
Current portion of capital lease
obligations
|
|
|
|
|
|
|
508 |
|
|
|
34 |
|
|
|
|
|
|
|
542 |
|
Accounts payable |
|
|
1,549 |
|
|
|
25,438 |
|
|
|
15,168 |
|
|
|
|
|
|
|
42,155 |
|
Accrued expenses and other current
liabilities |
|
|
12,935 |
|
|
|
22,939 |
|
|
|
28,872 |
|
|
|
|
|
|
|
64,746 |
|
Intercompany payables |
|
|
34,070 |
|
|
|
31,357 |
|
|
|
27,812 |
|
|
|
(93,239 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current liabilities |
|
|
48,554 |
|
|
|
80,242 |
|
|
|
74,253 |
|
|
|
(93,239 |
) |
|
|
109,810 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Long-term liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Long-term debt, net of current
portion |
|
|
169,456 |
|
|
|
60,000 |
|
|
|
29,161 |
|
|
|
|
|
|
|
258,617 |
|
Capital lease obligations, net of
current portion |
|
|
|
|
|
|
914 |
|
|
|
64 |
|
|
|
|
|
|
|
978 |
|
Deferred tax liabilities |
|
|
3,900 |
|
|
|
5,964 |
|
|
|
8,889 |
|
|
|
128 |
|
|
|
18,881 |
|
Other long-term liabilities |
|
|
|
|
|
|
278 |
|
|
|
5,294 |
|
|
|
|
|
|
|
5,572 |
|
Intercompany notes payable |
|
|
|
|
|
|
42,331 |
|
|
|
130,736 |
|
|
|
(173,067 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total long-term liabilities |
|
|
173,356 |
|
|
|
109,487 |
|
|
|
174,144 |
|
|
|
(172,939 |
) |
|
|
284,048 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders equity |
|
|
397,308 |
|
|
|
154,502 |
|
|
|
148,171 |
|
|
|
(302,673 |
) |
|
|
397,308 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities and
stockholders equity |
|
$ |
619,218 |
|
|
$ |
344,231 |
|
|
$ |
396,568 |
|
|
$ |
(568,851 |
) |
|
$ |
791,166 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
25
INVERNESS MEDICAL INNOVATIONS, INC. AND SUBSIDIARIES
CONSOLIDATING STATEMENT OF CASH FLOWS
For the Six Months Ended June 30, 2006
(unaudited)
(in thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Guarantor |
|
|
Non-Guarantor |
|
|
|
|
|
|
|
|
|
Issuer |
|
|
Subsidiaries |
|
|
Subsidiaries |
|
|
Eliminations |
|
|
Consolidated |
|
Cash Flows from Operating Activities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (loss) income |
|
$ |
(13,186 |
) |
|
$ |
6,618 |
|
|
$ |
751 |
|
|
$ |
(7,369 |
) |
|
$ |
(13,186 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Adjustments to reconcile net
(loss) income to net cash (used in)
provided by operating activities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Equity in earnings of
subsidiaries, net of tax |
|
|
(7,370 |
) |
|
|
|
|
|
|
|
|
|
|
7,370 |
|
|
|
|
|
Interest expense related to
amortization of original issue
discount and writeoff of
deferred financing costs |
|
|
593 |
|
|
|
448 |
|
|
|
357 |
|
|
|
|
|
|
|
1,398 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-cash income related to
currency |
|
|
(217 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(217 |
) |
Non-cash stock-based
compensation expense |
|
|
2,544 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,544 |
|
Depreciation and amortization |
|
|
4,446 |
|
|
|
5,891 |
|
|
|
7,635 |
|
|
|
|
|
|
|
17,972 |
|
Deferred income taxes |
|
|
187 |
|
|
|
1,093 |
|
|
|
(28 |
) |
|
|
|
|
|
|
1,252 |
|
Impairment
of long-lived assets |
|
|
|
|
|
|
5,216 |
|
|
|
3,927 |
|
|
|
|
|
|
|
9,143 |
|
Other non-cash items |
|
|
50 |
|
|
|
18 |
|
|
|
(1,267 |
) |
|
|
|
|
|
|
(1,199 |
) |
Changes in assets and
liabilities, net of acquisitions: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts receivable, net |
|
|
(697 |
) |
|
|
(5,678 |
) |
|
|
(2,920 |
) |
|
|
|
|
|
|
(9,295 |
) |
Inventories |
|
|
711 |
|
|
|
3,101 |
|
|
|
(2,897 |
) |
|
|
(1 |
) |
|
|
914 |
|
Prepaid expenses and other
current assets |
|
|
222 |
|
|
|
1 |
|
|
|
769 |
|
|
|
|
|
|
|
992 |
|
Accounts payable |
|
|
3,031 |
|
|
|
2,144 |
|
|
|
(311 |
) |
|
|
|
|
|
|
4,864 |
|
Accrued expenses and other
current liabilities |
|
|
167 |
|
|
|
(6,332 |
) |
|
|
(6,305 |
) |
|
|
|
|
|
|
(12,470 |
) |
Other long-term liabilities |
|
|
|
|
|
|
13 |
|
|
|
631 |
|
|
|
|
|
|
|
644 |
|
Intercompany payable
(receivable) |
|
|
2,142 |
|
|
|
(5,290 |
) |
|
|
1,628 |
|
|
|
1,520 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash (used in) provided by
operating activities |
|
|
(7,377 |
) |
|
|
7,243 |
|
|
|
1,970 |
|
|
|
1,520 |
|
|
|
3,356 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
26
INVERNESS MEDICAL INNOVATIONS, INC. AND SUBSIDIARIES
CONSOLIDATING STATEMENT OF CASH FLOWS (Continued)
For the Six Months Ended June 30, 2006
(unaudited)
(in thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Guarantor |
|
|
Non-Guarantor |
|
|
|
|
|
|
|
|
|
Issuer |
|
|
Subsidiaries |
|
|
Subsidiaries |
|
|
Eliminations |
|
|
Consolidated |
|
Cash Flows from Investing Activities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Purchases of property, plant and
equipment |
|
|
(307 |
) |
|
|
(2,340 |
) |
|
|
(6,555 |
) |
|
|
|
|
|
|
(9,202 |
) |
Proceeds from sale of
property, plant and equipment |
|
|
|
|
|
|
6 |
|
|
|
2,114 |
|
|
|
|
|
|
|
2,120 |
|
Cash paid for acquisitions,
net of cash acquired |
|
|
(61,191 |
) |
|
|
(58 |
) |
|
|
(16,682 |
) |
|
|
|
|
|
|
(77,931 |
) |
Decrease (increase) in other
assets |
|
|
914 |
|
|
|
(16 |
) |
|
|
211 |
|
|
|
|
|
|
|
1,109 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash used in investing activities |
|
|
(60,584 |
) |
|
|
(2,408 |
) |
|
|
(20,912 |
) |
|
|
|
|
|
|
(83,904 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash Flows from Financing Activities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash paid for financing costs |
|
|
|
|
|
|
(296 |
) |
|
|
(286 |
) |
|
|
|
|
|
|
(582 |
) |
Proceeds from issuance of
common stock, net of issuance costs |
|
|
83,573 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
83,573 |
|
Net borrowing (repayment) under
revolving lines of credit |
|
|
|
|
|
|
11,000 |
|
|
|
(2,183 |
) |
|
|
|
|
|
|
8,817 |
|
Repayments of notes payable |
|
|
|
|
|
|
|
|
|
|
(2,581 |
) |
|
|
|
|
|
|
(2,581 |
) |
Principal payments of capital
lease obligations |
|
|
|
|
|
|
(253 |
) |
|
|
(19 |
) |
|
|
|
|
|
|
(272 |
) |
Intercompany notes
(receivable) payable |
|
|
(15,895 |
) |
|
|
(11,000 |
) |
|
|
26,895 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by (used in) financing
activities |
|
|
67,678 |
|
|
|
(549 |
) |
|
|
21,826 |
|
|
|
|
|
|
|
88,955 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign exchange effect on cash and cash
equivalents |
|
|
|
|
|
|
|
|
|
|
1,007 |
|
|
|
(1,520 |
) |
|
|
(513 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (decrease) increase in cash and cash
equivalents |
|
|
(283 |
) |
|
|
4,286 |
|
|
|
3,891 |
|
|
|
|
|
|
|
7,894 |
|
Cash and cash equivalents, beginning of
period |
|
|
1,196 |
|
|
|
8,080 |
|
|
|
24,994 |
|
|
|
|
|
|
|
34,270 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents,
end of period |
|
$ |
913 |
|
|
$ |
12,366 |
|
|
$ |
28,885 |
|
|
$ |
|
|
|
$ |
42,164 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
27
INVERNESS MEDICAL INNOVATIONS, INC. AND SUBSIDIARIES
CONSOLIDATING STATEMENT OF CASH FLOWS
For the Six Months Ended June 30, 2005
(unaudited)
(in thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Guarantor |
|
|
Non-Guarantor |
|
|
|
|
|
|
|
|
|
Issuer |
|
|
Subsidiaries |
|
|
Subsidiaries |
|
|
Eliminations |
|
|
Consolidated |
|
Cash Flows from Operating Activities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (loss) income |
|
$ |
(5,299 |
) |
|
$ |
(6,095 |
) |
|
$ |
18,500 |
|
|
$ |
(12,405 |
) |
|
$ |
(5,299 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Adjustments to reconcile net
(loss) income to net cash (used in)
provided by operating activities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Equity in earnings of
subsidiaries, net of tax |
|
|
(14,653 |
) |
|
|
|
|
|
|
|
|
|
|
14,653 |
|
|
|
|
|
Interest expense related to
amortization of original issue
discount and write-off of
deferred financing costs |
|
|
589 |
|
|
|
196 |
|
|
|
114 |
|
|
|
|
|
|
|
899 |
|
Non-cash loss related to
currency |
|
|
592 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
592 |
|
Non-cash stock based
compensation expense |
|
|
140 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
140 |
|
Depreciation and amortization |
|
|
1,419 |
|
|
|
4,590 |
|
|
|
6,676 |
|
|
|
|
|
|
|
12,685 |
|
Deferred income taxes |
|
|
224 |
|
|
|
1,052 |
|
|
|
|
|
|
|
|
|
|
|
1,276 |
|
Impairment
of long-lived assets |
|
|
|
|
|
|
|
|
|
|
2,493 |
|
|
|
|
|
|
|
2,493 |
|
Other non-cash items |
|
|
141 |
|
|
|
(10 |
) |
|
|
(2,622 |
) |
|
|
|
|
|
|
(2,491 |
) |
Changes in assets and
liabilities, net of acquisitions: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts receivable, net |
|
|
969 |
|
|
|
12,067 |
|
|
|
1,371 |
|
|
|
|
|
|
|
14,407 |
|
Inventories |
|
|
586 |
|
|
|
1,527 |
|
|
|
(2,173 |
) |
|
|
(2,248 |
) |
|
|
(2,308 |
) |
Prepaid expenses and other
current assets |
|
|
(717 |
) |
|
|
(513 |
) |
|
|
(4,399 |
) |
|
|
|
|
|
|
(5,629 |
) |
Accounts payable |
|
|
1,027 |
|
|
|
(1,251 |
) |
|
|
588 |
|
|
|
|
|
|
|
364 |
|
Accrued expenses and other
current liabilities |
|
|
387 |
|
|
|
2,871 |
|
|
|
8,388 |
|
|
|
|
|
|
|
11,646 |
|
Other long-term liabilities |
|
|
|
|
|
|
|
|
|
|
433 |
|
|
|
|
|
|
|
433 |
|
Intercompany payable
(receivable) |
|
|
12,697 |
|
|
|
5,454 |
|
|
|
(18,570 |
) |
|
|
419 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash (used in) provided by
operating activities |
|
|
(1,898 |
) |
|
|
19,888 |
|
|
|
10,799 |
|
|
|
419 |
|
|
|
29,208 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
28
INVERNESS MEDICAL INNOVATIONS, INC. AND SUBSIDIARIES
CONSOLIDATING STATEMENT OF CASH FLOWS (Continued)
For the Six Months Ended June 30, 2005
(unaudited)
(in thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Guarantor |
|
|
Non-Guarantor |
|
|
|
|
|
|
|
|
|
Issuer |
|
|
Subsidiaries |
|
|
Subsidiaries |
|
|
Eliminations |
|
|
Consolidated |
|
Cash Flows from Investing Activities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Purchases of property, plant and
equipment |
|
|
(428 |
) |
|
|
(3,496 |
) |
|
|
(5,211 |
) |
|
|
|
|
|
|
(9,135 |
) |
Proceeds from sale of property,
plant and equipment |
|
|
|
|
|
|
69 |
|
|
|
82 |
|
|
|
|
|
|
|
151 |
|
Cash paid for acquisitions, net of
cash acquired |
|
|
(14,896 |
) |
|
|
1,671 |
|
|
|
(61,471 |
) |
|
|
|
|
|
|
(74,696 |
) |
(Increase) decrease in other assets |
|
|
117 |
|
|
|
(52 |
) |
|
|
(853 |
) |
|
|
|
|
|
|
(788 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash used in investing activities |
|
|
(15,207 |
) |
|
|
(1,808 |
) |
|
|
(67,453 |
) |
|
|
|
|
|
|
(84,468 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash Flows from Financing Activities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash paid for financing costs |
|
|
(707 |
) |
|
|
(702 |
) |
|
|
(649 |
) |
|
|
|
|
|
|
(2,058 |
) |
Proceeds from issuance of common
stock, net of issuance costs |
|
|
2,222 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,222 |
|
Net (repayment) borrowing under
revolving lines of credit |
|
|
(77 |
) |
|
|
20,000 |
|
|
|
29,249 |
|
|
|
|
|
|
|
49,172 |
|
Repayments of notes payable |
|
|
|
|
|
|
10,000 |
|
|
|
10,086 |
|
|
|
|
|
|
|
20,086 |
|
Principal payments of capital
lease obligations |
|
|
|
|
|
|
(233 |
) |
|
|
(4 |
) |
|
|
|
|
|
|
(237 |
) |
Intercompany notes payable
(receivable) |
|
|
16,000 |
|
|
|
(41,000 |
) |
|
|
25,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by (used in) financing
activities |
|
|
17,438 |
|
|
|
(11,935 |
) |
|
|
63,682 |
|
|
|
|
|
|
|
69,185 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign exchange effect on cash and cash
equivalents |
|
|
|
|
|
|
1 |
|
|
|
(1,377 |
) |
|
|
(419 |
) |
|
|
(1,795 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net increase in cash and cash
equivalents |
|
|
333 |
|
|
|
6,146 |
|
|
|
5,651 |
|
|
|
|
|
|
|
12,130 |
|
Cash and cash equivalents, beginning of
period |
|
|
12 |
|
|
|
3,551 |
|
|
|
13,193 |
|
|
|
|
|
|
|
16,756 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents, end of period |
|
$ |
345 |
|
|
$ |
9,697 |
|
|
$ |
18,844 |
|
|
$ |
|
|
|
$ |
28,886 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
29
ITEM 2. MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
Financial Overview
As a leading global manufacturer and supplier of rapid diagnostic products for consumer and
professional markets, we are continually exploring new opportunities for our proprietary
electrochemical and other technologies in a variety of professional diagnostic and
consumer-oriented applications, including immuno-diagnostics with a focus on womens health,
cardiology and infectious disease. Our emphasis on new product development requires substantial
investment and involves significant inherent risk. Our new product development efforts, as well as
our position as a leading supplier of consumer pregnancy and fertility/ovulation tests and rapid
point-of-care diagnostics, are supported by the strength of our intellectual property portfolio.
We intend to continue to devote substantial resources to research and development activities. Our
February 2005 co-development agreement with ITI Scotland Limited (ITI), who agreed to provide us
with approximately 30 million British Pounds Sterling over three years to fund certain new and
existing cardiovascular-related research and development initiatives, as well as development of our
new cardiac center in Stirling, Scotland, is evidence of this commitment. In addition, we will
continue to aggressively defend our substantial intellectual property portfolio, which underlies
our emphasis on new product development, against potential infringers.
For the three and six months ended June 30, 2006, we recorded net revenue of $139.7 million
and $267.5 million, respectively, compared to $102.3 million and $194.2 million, respectively, for
the three and six months ended June 30, 2005. Overall revenue growth for the six months ended June
30, 2006 resulted primarily from acquisitions principally in our professional diagnostics business
and, to a lesser extent, organic growth.
For the three and six months ended June 30, 2006, we incurred a net loss of $10.6 million and
$13.2 million, respectively, compared to a net income of $2.5 million and a net loss of $5.3
million, respectively, for the three and six months ended June 30, 2005. Included in the prior
year three and six-month periods was a net favorable impact resulting from settlement of disputes
and a licensing arrangement which totaled $13.5 million and $17.7 million, respectively, net of
tax.
During the six months ended June 30, 2006, we acquired (i) 67.45% of CLONDIAG chip
technologies GmbH (CLONDIAG), a privately-held company located in Jena in Germany which has
developed a multiplexing technology for nucleic acid and immunoassay-based diagnostics, for a
preliminary aggregate purchase price of $24.0 million, (ii) the assets of ACON Laboratories
business of researching, developing, manufacturing, marketing and selling lateral flow immunoassay
and directly-related products in the United States, Canada, Europe (excluding Russia, the former
Soviet Republics that are not part of the European Union, Spain, Portugal and Turkey), Israel,
Australia, Japan and New Zealand (Innovacon) and a newly-constructed manufacturing facility in Hangzhou, China
(ABON) pursuant to the terms of our acquisition agreement with ACON Laboratories, Inc. and
certain of its affiliates for a preliminary aggregate purchase price
of approximately $115.6 million
and (iii) a 49% interest in TechLab, Inc. (TechLab), a privately-held diagnostics company which
develops, manufactures and distributes rapid non-invasive intestinal diagnostics tests in the areas
of intestinal inflammation, antibiotic associated diarrhea and parasitology, for a purchase price
of $8.8 million.
On
May 22, 2006, we committed to a plan to cease operations at our manufacturing facility in
San Diego, California and to write off certain excess manufacturing equipment at other impacted
facilities. Additionally, on June 7, 2006, we committed to a
plan to reorganize the sales and
marketing and customer service functions in certain of our U.S. professional diagnostic companies.
As a result of these restructuring plans, we recorded $9.7 million in restructuring charges during
the three and six months ended June 30, 2006. We expect to complete these plans during the first
half of 2007. Including the charges recorded through June 30, 2006, we expect the total
restructuring charge related to these plans to be approximately $13.6 million.
Results of Operations
Net Revenue. Net revenue increased by $37.4 million, or 37%, to $139.7 million for the three
months ended June 30, 2006 from $102.3 million for the three months ended June 30, 2005. Net
revenue increased by $73.3 million, or 38%, to $267.5 million for the six months ended June 30,
2006, from $194.2 million for the six months ended June 30, 2005. The factors resulting in the
changes in net revenue for each comparative period are discussed in the Net Product Sales, Total
and by Business Segment and License and Royalty Revenue discussions which follow.
Net Product Sales, Total and by Business Segment. Net product sales increased by $38.8
million, or 40%, to $136.6 million for the three months ended
June 30, 2006, from $97.8 million for
the three months ended June 30, 2005. Net product sales increased by $71.9 million, or 38%, to
$259.4 million for the six months ended June 30, 2006, from $187.5 million for the six months ended
June 30, 2005. Net product sales by business segment for the three and six months ended June 30,
2006 and 2005 are as follows (in thousands):
30
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
|
|
|
Six Months Ended |
|
|
|
|
|
|
June 30, |
|
|
% |
|
|
June 30, |
|
|
% |
|
|
|
2006 |
|
|
2005 |
|
|
Change |
|
|
2006 |
|
|
2005 |
|
|
Change |
|
Consumer diagnostic products |
|
$ |
44,344 |
|
|
$ |
41,992 |
|
|
|
6 |
% |
|
$ |
85,542 |
|
|
$ |
83,927 |
|
|
|
2 |
% |
Vitamins and nutritional supplements |
|
|
22,094 |
|
|
|
18,918 |
|
|
|
17 |
% |
|
|
41,097 |
|
|
|
35,839 |
|
|
|
15 |
% |
Professional diagnostic products |
|
|
70,159 |
|
|
|
36,863 |
|
|
|
90 |
% |
|
|
132,711 |
|
|
|
67,706 |
|
|
|
96 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net product sales |
|
$ |
136,597 |
|
|
$ |
97,773 |
|
|
|
40 |
% |
|
$ |
259,350 |
|
|
$ |
187,472 |
|
|
|
38 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net product sales of our consumer diagnostic products increased by $2.4 million, or 6%,
comparing the three months ended June 30, 2006 to the three months ended June 30, 2005 and $1.6
million, or 2%, comparing the six months ended June 30, 2006 to the six months ended June 30, 2005.
Revenue from our March 31, 2006 acquisition of Innovacon accounted for the increase in each
period.
Our vitamins and nutritional supplements product sales increased by $3.2 million, or 17%,
comparing the three months ended June 30, 2006 to the three months ended June 30, 2005 and
increased by $5.3 million, or 15%, comparing the six months ended June 30, 2006 to the six months
ended June 30, 2005, with increased sales of our private label nutritional supplements accounting
for the majority of the growth in each comparative period.
Net product sales of our professional diagnostic products increased by $33.3 million, or 90%,
comparing the three months ended June 30, 2006 to the three months ended June 30, 2005 and
increased by $65.0 million, or 96%, comparing the six months ended June 30, 2006 to the six months
ended June 30, 2005. Net product revenue during the three months ended June 30, 2006 increased as a
result of our acquisitions of the Determine business in June 2005 which contributed $7.6 million;
IDT in September 2005 which contributed $3.7 million; BioStar in September 2005 which contributed
$5.8 million; CLONDIAG in February 2006 which contributed $0.9 million and Innovacon in March 2006
which contributed $15.1 million, for a total contribution of $33.1 million of net product sales
during the three months ended June 30, 2006. Net product revenue during the six months ended June 30,
2006 increased primarily as a result of our acquisitions of Binax in March 2005 which contributed
$9.7 million; the Determine business in June 2005 which contributed $15.8 million; IDT in September
2005 which contributed $7.5 million; BioStar in September 2005 which contributed $14.4 million;
CLONDIAG in February 2006 which contributed $1.0 million and Innovacon in March 2006 which
contributed $15.1 million, for a total contribution of $63.5 million of net product sales during
the six months ended June 30, 2006.
License and Royalty Revenue. License and royalty revenue represents license and royalty fees
from intellectual property license agreements with third-parties. License and royalty revenue
decreased by $1.4 million, or 31%, to $3.1 million for the three months ended June 30, 2006 from
$4.5 million for the three months ended June 30, 2005 and increased by $1.5 million, or 22%, to
$8.2 million for the six months ended June 30, 2006 from $6.7 million for the six months ended June
30, 2005. The decrease for the comparative three-month period is the result of higher than normal
royalty recognized during the three months ended June 30, 2005, related to the impact of a legal
settlement with Quidel Corporation in that quarter. The increase for the comparative six-month
period is primarily the result of royalty revenue from Quidel during the six months ended June 30,
2006, as a result of the settlement during the second quarter of 2005.
Gross Profit and Margin. Gross profit increased by $13.8 million, or 40%, to $48.5 million
for the three months ended June 30, 2006 from $34.7 million for the three months ended June 30,
2005. Gross profit during the three months ended June 30, 2006 benefited from higher than average
margins earned on revenue from our recently acquired businesses, offset by the lower royalties
recognized during the quarter. Included in cost of sales for the three months ended June 30, 2006
was a restructuring charge of $7.0 million related to the recently announced closure of our ABI
operation in San Diego, California, along with the write-off of fixed assets at other facilities
impacted by our restructuring plans and a $0.1 million charge for stock-based compensation related
to our January 1, 2006 adoption of Statement of Financial Accounting Standards (SFAS) No. 123-R,
Share-Based Payment. Included in cost of sales for the three months ended June 30, 2005 was a $2.9
million restructuring charge associated with our decision to close our Galway, Ireland
manufacturing facility and a $2.4 million charge associated with a reserve established at our
Wampole subsidiary for excess quantities of certain raw materials and finished goods, including
certain finished goods held at distributors but subject to right of return.
Gross profit increased by $33.8 million, or 51%, to $100.8 million for the six months ended
June 30, 2006 from $66.9 million for the six months ended June 30, 2005. Included in cost of sales
for the six months ended June 30, 2006 was a $7.7 million restructuring charge related to the
closures of our Galway, Ireland manufacturing facility and ABI operation in San Diego, California,
along with the write-off of fixed assets at other facilities impacted by our restructuring plans
and a $0.2 million charge for stock-based compensation related to our January 1, 2006 adoption of
SFAS No. 123-R. In addition to the $2.9 million restructuring charge and $2.4 million reserve
noted above during the three months ended June 30, 2005, the six months ended June 30, 2005 also
included a $1.6 million charge for returns and inventory reserve related to the recall of the drugs
of abuse diagnostic products.
31
Overall gross margin was 35% and 38% for the three and six months ended June 30, 2006,
respectively, compared to 34% for both the three and six months ended June 30, 2005. Excluding the
impact of the charges noted above in each of the respective periods in 2006, overall gross margin
was 40% and 41% for the three and six months ended June 30, 2006, respectively, compared to overall
gross margin in each of the respective periods for the three and six months ended June 30, 2005, of
39% and 38%, respectively.
Gross Profit from Net Product Sales by Business Segment. Gross profit from net product sales
represents total gross profit less gross profit associated with license and royalty revenue. Gross
profit from net product sales increased by $15.4 million, or 49%, to $46.7 million for the
three months ended June 30, 2006 from $31.3 million for the three months ended June 30, 2005.
Gross profit from net product sales increased by $33.0 million, or 53%, to $95.3 million for the
six months ended June 30, 2006 from $62.2 million for the six months ended June 30, 2005. Gross
profit from net product sales by business segment for the three and six months ended June 30, 2006
and 2005 are as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
|
|
|
Six Months Ended |
|
|
|
|
|
|
June 30, |
|
|
% |
|
|
June 30, |
|
|
% |
|
|
|
2006 |
|
|
2005 |
|
|
Change |
|
|
2006 |
|
|
2005 |
|
|
Change |
|
Consumer diagnostic products |
|
$ |
20,880 |
|
|
$ |
18,548 |
|
|
|
13 |
% |
|
$ |
41,176 |
|
|
$ |
39,472 |
|
|
|
4 |
% |
Vitamins and nutritional supplements |
|
|
2,180 |
|
|
|
1,238 |
|
|
|
76 |
% |
|
|
3,014 |
|
|
|
1,927 |
|
|
|
56 |
% |
Professional diagnostic products |
|
|
23,653 |
|
|
|
11,493 |
|
|
|
106 |
% |
|
|
51,087 |
|
|
|
20,844 |
|
|
|
145 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit
from net product sales |
|
$ |
46,713 |
|
|
$ |
31,279 |
|
|
|
49 |
% |
|
$ |
95,277 |
|
|
$ |
62,243 |
|
|
|
53 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross
profit from our consumer diagnostic product sales increased by
$2.3 million, or 13%, to
$20.9 million for the three months ended June 30, 2006, compared to $18.5 million for the three
months ended June 30, 2005. Gross profit from our consumer diagnostic product sales increased by
$1.7 million, or 4%, to $41.2 million for the six months ended June 30, 2006, compared to $39.5
million for the six months ended June 30, 2005. Included in the cost of sales for the three months
ended June 30, 2006 was a restructuring charge of $1.5 million related to the write-off of fixed
assets impacted by our recent restructuring plans and a charge of $0.1 million for stock-based
compensation related to our January 1, 2006 adoption of SFAS No. 123-R. Included in the cost of
sales for the three months ended June 30, 2005 was a $2.9 million restructuring charge associated
with our decision to close our Galway, Ireland manufacturing facility during this period.
Excluding the impact of the charges for restructuring and stock-based compensation, gross profit
for the three months ended June 30, 2006 was $22.5 million,
which represents an increase of $1.0 million, or 5%, as compared with $21.5 million the three months ended June 30, 2005 and resulted
principally from our March 31, 2006 acquisition of Innovacon. Cost of sales for the six months
ended June 30, 2006 included restructuring charges totaling $2.2 million related to the closure of
our Galway, Ireland manufacturing facility, the write-off of fixed assets as discussed above,
and a $0.2 million charge for stock-based compensation. During the six months ended June 30, 2005,
cost of sales included a restructuring charge of $2.9 million as discussed above. Excluding these
charges for the six months ended June 30, 2006 and 2005, gross
profit was $43.6 million and $42.4
million, respectively, which represents an increase of $1.2 million, or 3%, and resulted
principally from our March 31, 2006 acquisition of Innovacon.
As
a percentage of our consumer diagnostic product sales, gross margin
was 47% and 48% for the
three and six months ended June 30, 2006, respectively. Excluding the restructuring charges and
stock-based compensation discussed above, the gross margin percentage was 51% for both the three
and six months ended June 30, 2006. Gross margin percentages for the three and six months ended
June 30, 2005 were 44% and 47%, respectively, and, excluding the impact of the $2.9 million
restructuring charge discussed above, was 51% and 50% for the three and six months ended June 30,
2005, respectively.
Gross profit from our vitamins and nutritional supplements product sales increased $1.0
million, or 76%, to $2.2 million for the three months ended June 30, 2006, compared to $1.3 million
for the three months ended June 30, 2005. Gross profit from our vitamins and nutritional
supplements product sales increased $1.1 million, or 56%, to $3.0 million for the six months ended
June 30, 2006, compared to $1.9 million for the six months ended June 30, 2005. The gross profit
increase in both of the comparative periods was the result of improved factory utilization as a
result of increasing revenue in our private label business. As a percentage of net vitamin and
nutritional supplements product sales, gross profit for our vitamins and nutritional supplements
business was approximately 10% and 7% for the three and six months ended June 30, 2006,
respectively, compared to 7% and 5% for the three and six months ended June 30, 2005, respectively.
Gross
profit from our professional diagnostic product sales increased by
$12.2 million, or
106%, to $23.7 million for the three months ended June 30, 2006, compared to $11.5 million for the
three months ended June 30, 2005. Gross profit from our professional diagnostic product sales
increased by $30.2 million, or 145%, to $51.1 million for the six months ended June 30, 2006,
compared to $20.8 million for the six months ended June 30, 2005. The increase in gross profit
during the three months ended June 30, 2006 is largely attributable to the increase in product
sales resulting primarily from our acquisitions of BioStar, the Determine business, IDT and
Innovacon where higher margin products are sold. In addition to the acquisitions contributing to
the
32
gross profit improvement during the second quarter of 2006, our acquisition of Binax also
contributed to the gross profit improvement during the six months ended June 30, 2006, compared to
the six months ended June 30, 2005. Included in the cost of sales for the three and six months
ended June 30, 2006 was a $5.4 million restructuring charge associated with our decision to close
our ABI operations and the write-off of other fixed assets impacted by our other restructuring
plans. Excluding the impact of these charges during the three and six months ended June 30, 2006,
gross profit was $29.1 million and $56.5 million, respectively. Cost of sales for the three and
six months ended June 30, 2005 included a charge of $2.4 million associated with a reserve
established at our Wampole subsidiary for excess quantities of certain raw materials and finished
goods, including certain finished goods held at distributors but subject to right of return and a
$1.6 million charge related to a recall of the drugs of abuse diagnostic products. Excluding the
impact of these charges during the three and six months ended June 30, 2005, gross profit was $11.5
million and $20.8 million, respectively.
As a percentage of our professional diagnostic product sales, gross margin for the three and
six months ended June 30, 2006 was 34% and 38%, respectively.
Excluding the $5.4 million of charges
discussed above, gross margin as a percentage of our professional diagnostic product sales was 41%
and 43%, respectively. As a percentage of our professional diagnostic product sales, gross margin
for the three and six months ended June 30, 2005 was 31% in both periods. Excluding the combined
$4.0 million of charges discussed above, gross margin as a percentage of our professional diagnostic
product sales was 38% and 37%, respectively.
Research and Development Expense. Research and development expense increased by $7.8 million,
or 145%, to $13.1 million for the three months ended June 30, 2006, compared to $5.4 million for
the three months ended June 30, 2005. Research and development expense increased by $11.1 million,
or 88%, to $23.7 million for the six months ended June 30, 2006, compared to $12.6 million for the
six months ended June 30, 2005. Research and development expense is reported net of co-development
funding from ITI of $4.0 million and $7.9 million for the three and six months ended June 30, 2006,
respectively. ITI funding during the three and six months ended June 30, 2005 was $6.9 million and
$8.8 million, respectively. The increase in research and development expense for the comparative
three-month periods was primarily the result of increased spending related to our cardiology
research programs, $1.1 million of additional spending related to our recent acquisitions, a $2.6
million charge related to the write-off of fixed assets impacted by our restructuring plans and a
$0.3 million charge for stock-based compensation related to our January 1, 2006 adoption of SFAS
No. 123-R. The increase for the comparative six-month periods was primarily the result of
increased spending related to our cardiology research programs, $3.3 million of additional spending
related to our recent acquisitions, a $2.6 million charge related to the write-off of fixed assets
impacted by our restructuring plans and a $0.5 million charge for stock-based compensation related
to our January 1, 2006 adoption of SFAS No. 123-R.
Research and development expense as a percentage of net product sales is 10% and 9% for the
three and six months ended June 30, 2006, respectively, compared to 5% and 7% for the three and six
months ended June 30, 2005, respectively. Excluding the $2.6 million in fixed asset write-off
discussed above, research and development expense as a percentage of
net product sales is 8% for both
the three and six-month periods ended June 30, 2006.
Sales and Marketing Expense. Sales and marketing expense increased by $5.0 million, or 28%,
to $22.7 million for the three months ended June 30, 2006, compared to $17.7 million for the three
months ended June 30, 2005. Sales and marketing expense increased by $8.8 million, or 25%, to
$43.5 million for the six months ended June 30, 2006, compared to $34.7 million for the six months
ended June 30, 2005. The increase in sales and marketing expense during the three and six months
ended June 30, 2006 was primarily the result of approximately $3.9 million and $8.1 million of
additional spending related to our acquisitions, in the respective periods, and a charge of $0.2
million and $0.4 million, respectively, for stock-based compensation related to our January 1, 2006
adoption of SFAS No. 123-R.
Sales
and marketing expense as a percentage of net product sales was 17% during both
the three and six months ended June 30, 2006, compared
to 18% and 19% for the three and six months ended June 30, 2005,
respectively.
General and Administrative Expense. General and administrative expense increased by $1.4
million, or 9%, to $17.7 million for the three months ended June 30, 2006, compared to $16.2
million for the three months ended June 30, 2005. General and administrative expense increased by
$3.2 million, or 10%, to $33.5 million for the six months ended June 30, 2006, compared to $30.4
million for the six months ended June 30, 2005. For the three and six months ended June 30, 2006,
approximately $3.3 million and $5.4 million, respectively, of the increase in general and
administrative expense resulted from additional spending related to our acquisitions of Binax,
BioStar, IDT, the Determine business, CLONDIAG, Innovacon and ABON. Included in general and
administrative expense is a $0.7 million and a $1.5 million charge for stock-based compensation
related to our January 1, 2006 adoption of SFAS No. 123-R for the three and six-month periods in
2006, respectively. Increases in general and administrative expenses during the three and six
months ended June 30, 2006 were partially offset by decreases in legal expenses in both periods of
$1.9 million and $3.7 million, respectively.
Loss
on Dispositions, Net. During the three and six months ended June 30, 2006, we recorded a
net loss of $3.2 million. Included in this charge is a loss of $4.6 million associated with
managements decision to dispose of our SMB research operation.
33
The $4.6 million charge includes a loss of $2.0 million on impaired assets, most of which
represents goodwill associated with SMB, and a $2.6 million estimated loss on the sale of SMB. We
expect the sale of this operation to be completed in the third quarter of 2006. The $4.6 million
loss is offset by a $1.4 million gain on the sale of an idle manufacturing facility in Galway,
Ireland, as a result of our 2005 restructuring plan.
Interest Expense. Interest expense includes interest charges, the write-off and amortization
of deferred financing costs and the amortization of non-cash discounts associated with our debt
issuances. Interest expense increased by $1.9 million, or 39%, to $6.9 million for the three
months ended June 30, 2006 from $5.0 million for the three months ended June 30, 2005. Interest
expense increased by $2.6 million, or 26%, to $12.6 million for the six months ended June 30, 2006
from $10.0 million for the six months ended June 30, 2005. Such increases were partially due to higher average outstanding debt balances which were $267.9 million and $269.7 million during the
three and six months ended June 30, 2006, respectively, compared to $237.0 million and $225.8
million during the three and six months ended June 30, 2005, respectively, as a result of
borrowings to fund various acquisitions and operations. Additionally, higher applicable interest
rates on the senior credit facility during the six months ended June 30, 2006 compared with the six
months ended June 30, 2005 and an increase in the amortization of deferred financing costs related
to the debt refinancings that occurred later in fiscal year 2005 and during the first quarter of
2006 contributed to the increase in interest expense.
Other Income (Expense), Net. Other income (expense), net includes interest income, realized
and unrealized foreign exchange gains and losses, and other income and expense. The components and
the respective amounts of other income, net are summarized as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
|
|
|
Six Months Ended |
|
|
|
|
|
|
June 30, |
|
|
% |
|
|
June 30, |
|
|
% |
|
|
|
2006 |
|
|
2005 |
|
|
Change |
|
|
2006 |
|
|
2005 |
|
|
Change |
|
Interest income |
|
$ |
286 |
|
|
$ |
267 |
|
|
|
7 |
% |
|
$ |
619 |
|
|
$ |
505 |
|
|
|
23 |
% |
Foreign exchange gains (losses), net |
|
|
4,953 |
|
|
|
(303 |
) |
|
|
1,735 |
% |
|
|
3,343 |
|
|
|
(118 |
) |
|
|
2,933 |
% |
Other |
|
|
62 |
|
|
|
14,908 |
|
|
|
(100 |
)% |
|
|
911 |
|
|
|
19,396 |
|
|
|
(95 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense), net |
|
$ |
5,301 |
|
|
$ |
14,872 |
|
|
|
(64 |
)% |
|
$ |
4,873 |
|
|
$ |
19,783 |
|
|
|
(75 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Included in other income (expense), net for the three and six months ended June 30, 2006 was a
foreign exchange gain of $5.5 million and $4.3 million, respectively, associated with the closure
of our Galway, Ireland manufacturing operation. Included in other income (expense), net for the
three and six months ended June 30, 2005 was income of $15.0 million related to the Quidel legal
settlement and $2.6 million related to the value of an option received under a licensing
arrangement entered into during the second quarter of 2005, offset by a $2.7 million charge related
to a legal settlement of a nutritional segment commercial dispute arising from a distribution
arrangement entered into in September 1996. In addition, other income (expense), net for the six
months ended June 30, 2005 includes an $8.4 million gain from a legal settlement of class action
suit against several raw material suppliers in our vitamins and nutritional supplements business
and a $4.3 million charge related to a legal settlement with PBM.
Provision for Income Taxes. Provision for income taxes was $0.8 million and $2.3 million for
the three and six months ended June 30, 2006, respectively, compared to $2.9 million and $4.4
million for the three and six months ended June 30, 2005, respectively. The effective tax rate was
(8)% and (21)% for the three and six months ended June 30, 2006, respectively, compared to 53% and
(469)% for the three and six months ended June 30, 2005, respectively. The income tax provision
for both comparative periods is primarily related to the recognition of U.S. deferred tax
liabilities for temporary differences between the book and tax basis of goodwill and certain
intangible assets with indefinite lives, state income tax provision and foreign income tax
provisions for various foreign subsidiaries.
Net Loss. We incurred a net loss of $10.6 million, or $0.33 per basic and diluted common
share, for the three months ended June 30, 2006, compared to net income of $2.5 million, or $0.10
per diluted common share, for the three months ended June 30, 2005 and a net loss of $13.2 million,
or $0.42 per basic and diluted common share, for the six months ended June 30, 2006, compared to a
net loss of $5.3 million, or $0.24 per basic and diluted common share, for the six months ended
June 30, 2005. The decrease in net income (loss) for the comparative three and six months ended
June 30, 2006 and June 30, 2005, primarily resulted from the various factors as discussed above.
See Note 5 of the accompanying consolidated financial statements for the calculation of net income
(loss) per common share.
Liquidity and Capital Resources
Based upon our current working capital position, current operating plans and expected business
conditions, we believe that our existing capital resources, credit facilities and expected funding
resulting from our co-development funding agreement with ITI will be adequate to fund our
operations, including our outstanding debt and other commitments, as discussed below, for the
34
next 12 months. We expect to fund our working capital needs and other commitments primarily
through the co-development funding program with ITI and through our operating cash flow, which we
expect to improve as we grow our business through new product introductions and by continuing to
leverage our strong intellectual property position. We also expect to rely on our credit
facilities to fund a portion of our capital needs and other commitments.
Our funding plans for our working capital needs and other commitments may be adversely
impacted by unexpected costs associated with prosecuting and defending our existing lawsuits and/or
unforeseen lawsuits against us, integrating the operations of newly acquired companies and
executing our cost savings strategies. We also cannot be certain that our underlying assumed levels
of revenues and expenses will be realized. In addition, we intend to continue to make significant
investments in our research and development efforts related to the substantial intellectual
property portfolio we own. We may also choose to further expand our research and development
efforts and may pursue the acquisition of new products and technologies through licensing
arrangements, business acquisitions, or otherwise. We may also choose to make significant
investment to pursue legal remedies against potential infringers of our intellectual property. If
we decide to engage in such activities, or if our operating results fail to meet our expectations,
we could be required to seek additional funding through public or private financings or other
arrangements. In such event, adequate funds may not be available when needed, or, may be available
only on terms which could have a negative impact on our business and results of operations. In
addition, if we raise additional funds by issuing equity or convertible securities, dilution to
then existing stockholders may result.
Changes in Cash Position
As of June 30, 2006, we had cash and cash equivalents of $42.2 million, a $7.9 million
increase from December 31, 2005. Our primary source of cash during the six months ended June 30,
2006, was $83.6 million in proceeds from the issuance of our
common stock including common
stock issues under employee stock option and stock purchase plans. During the six months ended
June 30, 2006, our operating activities provided $3.3 million of cash to fund our net loss of $13.2
million and a $14.4 million use of cash associated with an increase in working capital, which were
offset by $30.9 million of non-cash items. Our investing activities during the six months ended
June 30, 2006 used $83.9 million of cash and consisted primarily of $77.9 million of cash used for
acquisitions and $9.2 million used for capital equipment purchases, offset by a net $3.2 million of
proceeds from the sale of our Galway, Ireland facility and sales of capital equipment, along with
decreases in other assets. Our non-equity financing activities, primarily borrowings under our
primary senior credit facility, net of various debt repayments and financing costs, provided cash
of $5.4 million during the six months ended June 30, 2006. Fluctuations in foreign currencies
adversely impacted our cash balance by $0.5 million during the six months ended June 30, 2006.
Investing Activities
During the six months ended June 30, 2006, we paid $77.9 million in cash for acquisitions and
transaction related costs, net of cash acquired, primarily with respect to our acquisitions of
CLONDIAG, Innovacon and ABON during this period.
On
February 28, 2006, we acquired 67.45% of CLONDIAG, a
privately-held company located in Jena in
Germany which has developed a multiplexing technology for nucleic acid and immunoassay based
diagnostics. Pursuant to the acquisition agreement, we are required to purchase the remaining
32.55% on or before August 31, 2006. The initial aggregate
purchase price was $22.7 million, which
consisted of $11.8 million in cash, 218,502 shares of our common stock with an aggregate fair value
of $5.8 million and a $5.1 million payable to acquire the remaining 32.55% stock ownership.
Additionally, pursuant to the terms of the acquisition agreement, we
have an obligation to settle existing employee bonus arrangements with
the CLONDIAG employees totaling
1.1 million
($1.3 million). In connection with this obligation, we issued
24,896 shares of our common stock with a fair value of
$0.7 million to the employees of CLONDIAG and a cash payment of
$0.5 million. As of June 30, 2006, our remaining obligation
was $0.1 million. This obligation increased our aggregate
purchase price to $24.0 million as of June 30, 2006 and
resulted in additional goodwill. The
terms of the acquisition agreement also provided for contingent consideration totaling
approximately $8.9 million consisting of 224,316 shares of our common stock and approximately $3.0
million of cash or stock in the event that four specified products are developed on CLONDIAGs
platform technology during the three years following the acquisition date. This contingent
consideration will be accounted for as an increase in the aggregate purchase price, if and when the
contingency occurs.
On March 31, 2006, we acquired Innovacon, consisting of the assets of ACON Laboratories
business of researching, developing, manufacturing, marketing and selling lateral flow immunoassay
and directly-related products in the United States, Canada, Europe (excluding Russia, the former
Soviet Republics that are not part of the European Union, Spain, Portugal and Turkey), Israel,
Australia, Japan and New Zealand. The preliminary aggregate purchase price was approximately $91.2
million which consisted of $55.1 million in cash, 711,676 shares of our common stock with an
aggregate fair value of $19.7 million, $6.4 million in estimated direct acquisition costs and an
additional minimum liability of $10.0 million payable to the sellers on the deferred payment date,
pursuant to the acquisition agreement. In addition to the amounts described above, we will be
required to make additional cash payments of approximately $51.2 million upon the completion of the
permitting, validation and obtainment of operational capacity of the ABON facility and regulatory
clearance in Spain and Portugal. The timing and amount of any such payments is contingent upon the
successful completion of various milestones, as defined in the acquisition agreement, and certain
regulatory approvals.
On May 15, 2006, we acquired ABON, a newly-constructed manufacturing facility in Hangzhou,
China, pursuant to the terms of our acquisition agreement with ACON Laboratories, Inc. and its
affiliates, dated March 31, 2006, in connection with our
35
acquisition of Innovacon, as discussed above. The preliminary aggregate purchase was
approximately $20.4 million which consisted of $8.8 million in cash and 417,446 shares of our
common stock with an aggregate fair value of $11.6 million. In
addition, pursuant to the acquisition agreement, we made an
additional payment of $4.1 million in cash as a result of the
amount of cash acquired, net of indebtedness assumed.
Financing Activities
On February 8 and 9, 2006, we sold an aggregate 3,400,000 shares of our common stock at $24.41
per share to funds affiliated with 14 accredited institutional investors in a private placement.
Proceeds from the private placement were approximately $79.3 million, net of issuance costs of $3.7
million. Of this amount, we repaid principal and interest outstanding under our senior credit
facility of $74.1 million, with the remainder of the net proceeds retained for general corporate
purposes.
As of
June 30, 2006, we had an aggregate of $1.4 million in outstanding capital lease
obligations which are payable through 2009.
Income Taxes
As of December 31, 2005, we had approximately $170.2 million and $26.0 million of domestic and
foreign net operating loss, or NOL, carryforwards, respectively, which either expire on various
dates through 2025 or can be carried forward indefinitely. These losses are available to reduce
federal and foreign taxable income, if any, in future years. These losses are also subject to
review and possible adjustments by the applicable taxing authorities. In addition, the domestic
operating loss carryforward amount at December 31, 2005 included approximately $71.2 million of
pre-acquisition losses from our subsidiaries, Inverness Medical Nutritionals Group, Ischemia, Ostex
International, Inc. and Advantage Diagnostics Corporation. The future benefit of these losses will
be applied first to reduce to zero any goodwill and other non-current intangible assets related to
the acquisitions, prior to reducing our income tax expense. Also included in our domestic NOL
carryforwards at December 31, 2005 was approximately $2.6 million resulting from the exercise of
employee stock options, the tax benefit of which, when recognized, will be accounted for as a
credit to additional paid-in capital rather than a reduction of income tax. Furthermore, all
domestic losses are subject to the Internal Revenue Service Code Section 382 limitation and may be
limited in the event of certain cumulative changes in ownership interests of significant
shareholders over a three-year period in excess of 50%. Section 382 imposes an annual limitation
on the use of these losses to an amount equal to the value of the company at the time of the
ownership change multiplied by the long term tax exempt rate. We have recorded a valuation
allowance against a portion of the deferred tax assets related to our net operating losses and
certain of our other deferred tax assets to reflect uncertainties that might affect the realization
of such deferred tax assets, as these assets can only be realized via profitable operations.
Off-Balance Sheet Arrangements
We had no material off-balance sheet arrangements as of June 30, 2006.
Contractual Obligations
The following table summarizes our principal contractual obligations as of June 30, 2006 that
have changed significantly since December 31, 2005 and the effects such obligations are expected to
have on our liquidity and cash flow in future periods. Contractual obligations that were presented
in our Annual Report on Form 10-K for the year ended December 31, 2005 but omitted in the table
below represent those that have not changed significantly since that date.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Payments Due by Period |
Contractual Obligations |
|
Total |
|
2006 |
|
2007 - 2008 |
|
2009 - 2010 |
|
Thereafter |
|
|
(in thousands) |
Long-term debt obligations (1) |
|
$ |
276,080 |
|
|
$ |
1,523 |
|
|
$ |
124,557 |
|
|
$ |
|
|
|
$ |
150,000 |
|
Purchase of remaining CLONDIAG business (2) |
|
|
5,100 |
|
|
|
5,100 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Remaining
obligations Innovacon/ABON (3) |
|
|
61,180 |
|
|
|
41,180 |
|
|
|
20,000 |
|
|
|
|
|
|
|
|
|
Purchase
obligations other (4) |
|
|
42,119 |
|
|
|
42,119 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest on
debt (5) |
|
|
82,774 |
|
|
|
7,579 |
|
|
|
29,794 |
|
|
|
26,256 |
|
|
|
19,145 |
|
|
|
|
Total |
|
$ |
467,253 |
|
|
$ |
97,501 |
|
|
$ |
174,351 |
|
|
$ |
26,256 |
|
|
$ |
169,145 |
|
|
|
|
|
|
|
(1) |
|
Long-term debt obligations increased by $13.6 million since December 31, 2005 primarily
due to our borrowings under the lines of credit of our primary senior credit facility
during the six months ended June 30, 2006 and the assumption of approximately $5.6 million
in long-term debt related to our acquisition of ABON. |
|
(2) |
|
In connection with our acquisition of CLONDIAG, the acquisition agreement requires us
to purchase the remaining 32.55% of this business or before August 31, 2006 for
approximately $5.1 million. (See Note 8(b) of our accompanying consolidated financial
statements.) |
|
(3) |
|
In connection with our acquisition of Innovacon/ABON, we are
required to make additional payments of $51.2 million upon the
completion of the permitting validation and obtainment of operational
capacity of the ABON facility and regulatory clearance in Spain and
Portugal. Also, pursuant to the acquisition agreement, we are obligated
to pay an additional $10.0 million to the sellers on the
deferred payment date. |
|
(4) |
|
Other purchase obligations relate to inventory purchases and other operating expense
commitments. Other purchase obligations increased by $6.4 million, as compared to the
commitments at December 31, 2005, primarily due to our efforts to reduce our raw material
costs in our nutritional business by executing certain bulk purchase commitments. |
36
|
|
|
(5) |
|
Interest on debt includes amounts based on our $150.0 million senior subordinated notes
and $20.0 million subordinated promissory notes. Amounts exclude interest on all other
debt due to the variable interest rates (see Note 12 of our accompanying consolidated
financial statements). Interest on debt has decreased by $2.9 million since December 31,
2005. |
As of June 30, 2006, we had outstanding material contingent contractual obligations
related to our acquisitions of Binax and CLONDIAG. With respect to Binax, the terms of the
acquisition agreement provide for $11.0 million of contingent cash consideration payable to the
Binax shareholders upon the successful completion of certain new product developments during the
five years following the acquisition. With respect to the acquisition
of CLONDIAG, in the event that the value of the 218,502 shares
of our common stock issued in connection with the acquisition is less
than
4.87 million
on December 29, 2006, we will be required to pay the sellers
additional cash in the amount of the shortfall. In addition, the terms of
the acquisition agreement provide for $8.9 million of contingent consideration, consisting of
224,316 shares of our common stock and approximately $3.0 million of cash or stock in the event
that four specified products are developed on CLONDIAGs platform technology during the three years
following the acquisition date.
Critical Accounting Policies
The consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q
are prepared in accordance with accounting principles generally accepted in the United States of
America, or GAAP. The accounting policies discussed below are considered by our management and our
audit committee to be critical to an understanding of our financial statements because their
application depends on managements judgment, with financial reporting results relying on estimates
and assumptions about the effect of matters that are inherently uncertain. Specific risks for
these critical accounting policies are described in the following paragraphs. For all of these
policies, management cautions that future events rarely develop exactly as forecast and the best
estimates routinely require adjustment. In addition, the notes to our audited consolidated
financial statements for the year ended December 31, 2005 included in our Annual Report on Form
10-K include a comprehensive summary of the significant accounting policies and methods used in the
preparation of our consolidated financial statements.
Revenue Recognition
We primarily recognize revenue when the following four basic criteria have been met: (1)
persuasive evidence of an arrangement exists; (2) delivery has occurred or services rendered; (3)
the fee is fixed and determinable; and (4) collection is reasonably assured.
The majority of our revenue is derived from product sales. We recognize revenue upon
title transfer of the products to third-party customers, less a reserve for estimated product
returns and allowances. Determination of the reserve for estimated product returns and allowances
is based on our managements analyses and judgments regarding certain conditions, as discussed
below in the critical accounting policy Use of Estimates for Sales Returns and Other Allowances
and Allowance for Doubtful Accounts. Should future changes in conditions prove managements
conclusions and judgments on previous analyses to be incorrect, revenue recognized for any
reporting period could be adversely affected.
In connection with the acquisition of the rapid diagnostics business in September 2003 and the
Determine business in June 2005 from Abbott Laboratories, we entered into a transition services
agreement with Abbott, whereby Abbott would continue to distribute certain of the acquired products
for a period of up to 18 months following each acquisition, subject to certain extensions. During
the transition period, we recognized revenue on sales of the products when title transferred from
Abbott to third party customers.
We also receive license and royalty revenue from agreements with third-party licensees.
Revenue from fixed fee license and royalty agreements are recognized on a straight-line basis over
the obligation period of the related license agreements. License and royalty fees that the
licensees calculate based on their sales, which we have the right to audit under most of our
agreements, are generally recognized upon receipt of the license or royalty payments unless we are
able to reasonably estimate the fees as they are earned. License and royalty fees that are
determinable prior to the receipt thereof are recognized in the period they are earned.
Use of Estimates for Sales Returns and Other Allowances and Allowance for Doubtful Accounts
Certain sales arrangements require us to accept product returns. From time to time, we also
enter into sales incentive arrangements with our retail customers, which generally reduce the sale
prices of our products. As a result, we must establish allowances for potential future product
returns and claims resulting from our sales incentive arrangements against product revenue
recognized in any reporting period. Calculation of these allowances requires significant judgments
and estimates. When evaluating the adequacy of the sales returns and other allowances, our
management analyzes historical returns, current economic trends, and changes in customer and
consumer demand and acceptance of our products. When such analysis is not available and a right of
return exists the Company records revenue when the right of return is no longer applicable.
Material differences in the amount and timing of our product revenue for any reporting period may
result if changes in conditions arise that would require management to make different judgments or
utilize different estimates.
37
Our total provision for sales returns and other allowances related to sales incentive
arrangements amounted to $10.4 million and $24.5 million, or 7% and 9%, respectively, of product
sales for the three and six months ended June 30, 2006, compared to $13.3 million and $26.7
million, or 12% and 12%, respectively, of product sales for the three and six months ended June 30,
2005, respectively, which have been recorded against product sales to derive our net product sales.
Similarly, our management must make estimates regarding uncollectible accounts receivable
balances. When evaluating the adequacy of the allowance for doubtful accounts, management analyzes
specific accounts receivable balances, historical bad debts, customer concentrations, customer
credit-worthiness, current economic trends and changes in our customer payment terms and patterns.
Our accounts receivable balance was $92.0 million and $70.5 million, net of allowances for doubtful
accounts of $8.9 million and $9.7 million, as of June 30, 2006 and December 31, 2005, respectively.
Valuation of Inventories
We state our inventories at the lower of the actual cost to purchase or manufacture the
inventory or the estimated current market value of the inventory. In addition, we periodically
review the inventory quantities on hand and record a provision for excess and obsolete inventory.
This provision reduces the carrying value of our inventory and is calculated based primarily upon
factors such as forecasts of our customers demands, shelf lives of our products in inventory, loss
of customers, manufacturing lead times and, less commonly, decisions to withdraw our products from
the market. Evaluating these factors, particularly forecasting our customers demands, requires
management to make assumptions and estimates. Actual product sales may prove our forecasts to be
inaccurate, in which case we may have underestimated or overestimated the provision required for
excess and obsolete inventory. If, in future periods, our inventory is determined to be
overvalued, we would be required to recognize the excess value as a charge to our cost of sales at
the time of such determination. Likewise, if, in future periods, our inventory is determined to be
undervalued, we would have over-reported our cost of sales, or understated our earnings, at the
time we recorded the excess and obsolete provision. Our inventory balance was $76.1 million and
$71.2 million, net of a provision for excess and obsolete inventory of $7.5 million and $7.7
million, as of June 30, 2006 and December 31, 2005, respectively.
Valuation of Goodwill and Other Long-Lived and Intangible Assets
Our long-lived assets include (1) property, plant and equipment, (2) goodwill and (3) other
intangible assets. As of June 30, 2006, the balances of property, plant and equipment, goodwill
and other intangible assets, net of accumulated depreciation and amortization, were $79.8 million,
$388.6 million and $229.4 million, respectively.
Goodwill and other intangible assets are initially created as a result of business
combinations or acquisitions of intellectual property. The values we record for goodwill and other
intangible assets represent fair values calculated by accepted valuation methods. Such valuations
require us to provide significant estimates and assumptions which are derived from information
obtained from the management of the acquired businesses and our business plans for the acquired
businesses or intellectual property. Critical estimates and assumptions used in the initial
valuation of goodwill and other intangible assets include, but are not limited to: (i) future
expected cash flows from product sales, customer contracts and acquired developed technologies and
patents, (ii) expected costs to complete any in-process research and development projects and
commercialize viable products and estimated cash flows from sales of such products, (iii) the
acquired companies brand awareness and market position, (iv) assumptions about the period of time
over which we will continue to use the acquired brand, and (v) discount rates. These estimates and
assumptions may be incomplete or inaccurate because unanticipated events and circumstances may
occur. If estimates and assumptions used to initially value goodwill and intangible assets prove
to be inaccurate, ongoing reviews of the carrying values of such goodwill and intangible assets, as
discussed below, may indicate impairment which will require us to record an impairment charge in
the period in which we identify the impairment.
Where we believe that property, plant and equipment and intangible assets have finite lives,
we depreciate and amortize those assets over their estimated useful lives. For purposes of
determining whether there are any impairment losses, as further discussed below, our management has
historically examined the carrying value of our identifiable long-lived tangible and intangible
assets and goodwill, including their useful lives where we believe such assets have finite lives,
when indicators of impairment are present. In addition, SFAS No. 142, Goodwill and Other
Intangible Assets, requires that impairment reviews be performed on the carrying values of all
goodwill on at least an annual basis. For all long-lived tangible and intangible assets and
goodwill, if an impairment loss is identified based on the fair value of the asset, as compared to
the carrying value of the asset, such loss would be charged to expense in the period we identify
the impairment. Furthermore, if our review of the carrying values of the long-lived tangible and
intangible assets with finite lives indicates impairment of such assets, we may determine that
shorter estimated useful lives are more appropriate. In that event, we will be required to record
additional depreciation and amortization in future periods, which will reduce our earnings.
38
Valuation of Goodwill
We have goodwill balances related to our consumer diagnostics and professional diagnostics
(which includes cardiology) reporting units, which amounted to $85.6 million and $303.0 million,
respectively, as of June 30, 2006. As of September 30, 2005, we performed our annual impairment
review on the carrying values of such goodwill using the discounted cash flows approach. Based
upon this review, we do not believe that the goodwill related to our consumer diagnostics and
professional diagnostics reporting units were impaired. Because future cash flows and operating
results used in the impairment review are based on managements projections and assumptions, future
events can cause such projections to differ from those used at September 30, 2005, which could lead
to significant impairment charges of goodwill in the future. No events or circumstances have
occurred since our review as of September 30, 2005, that would require us to reassess whether the
carrying values of our goodwill have been impaired.
Valuation of Other Long-Lived Tangible and Intangible Assets
Factors we generally consider important which could trigger an impairment review on the
carrying value of other long-lived tangible and intangible assets include the following: (1)
significant underperformance relative to expected historical or projected future operating results;
(2) significant changes in the manner of our use of acquired assets or the strategy for our overall
business; (3) underutilization of our tangible assets; (4) discontinuance of product lines by
ourselves or our customers; (5) significant negative industry or economic trends; (6) significant
decline in our stock price for a sustained period; (7) significant decline in our market
capitalization relative to net book value; and (8) goodwill impairment identified during an
impairment review under SFAS No. 142. Although we believe that the carrying value of our
long-lived tangible and intangible assets was realizable as of June 30, 2006, future events could
cause us to conclude otherwise.
Stock-Based Compensation
As of January 1, 2006, we account for stock-based compensation in accordance with SFAS No.
123-R, Share-Based Payment. Under the fair value recognition provisions of this statement,
share-based compensation cost is measured at the grant date based on the value of the award and is
recognized as expense over the vesting period. Determining the fair value of share-based awards at
the grant date requires judgment, including estimating our stock price volatility and employee
stock option exercise behaviors. If actual results differ significantly from these estimates,
stock-based compensation expense and our results of operations could be materially impacted.
Our expected volatility is based upon the historical volatility of our stock. We have chosen
to utilize the simplified method to calculate the expected life of options which averages an
awards weighted average vesting period and its contractual term. As stock-based compensation
expense is recognized in our consolidated statement of operations is based on awards ultimately
expected to vest, the amount of expense has been reduced for estimated forfeitures. SFAS No. 123-R
requires forfeitures to be estimated at the time of grant and revised, if necessary, in subsequent
periods if actual forfeitures differ from those estimates. Forfeitures were estimated based on
historical experience. If factors change and we employ different assumptions in the application of
SFAS No.123-R, the compensation expense that we record in future periods may differ significantly
from what we have recorded in the current period.
Accounting for Income Taxes
As part of the process of preparing our consolidated financial statements, we are required to
estimate our income taxes in each of the jurisdictions in which we operate. This process involves
us estimating our actual current tax exposure and assessing temporary differences resulting from
differing treatment of items, such as reserves and accruals and lives assigned to long-lived and
intangible assets, for tax and accounting purposes. These differences result in deferred tax
assets and liabilities. We must then assess the likelihood that our deferred tax assets will be
recovered through future taxable income and, to the extent we believe that recovery is not likely,
we must establish a valuation allowance. To the extent we establish a valuation allowance or
increase this allowance in a period, we must include an expense within our tax provision.
Significant management judgment is required in determining our provision for income taxes, our
deferred tax assets and liabilities and any valuation allowance recorded against our net deferred
tax assets. We have recorded a valuation allowance of $96.7 million as of December 31, 2005 due to
uncertainties related to the future benefits, if any, from our deferred tax assets related
primarily to our U.S. businesses and certain foreign net operating losses and tax credits. The
valuation allowance is based on our estimates of taxable income by jurisdiction in which we operate
and the period over which our deferred tax assets will be recoverable. In the event that actual
results differ from these estimates or we adjust these estimates in future periods, we may need to
establish an additional valuation allowance or reduce our current valuation allowance which could
materially impact our tax provision.
In accordance with SFAS No. 109, Accounting for Income Taxes, and SFAS No. 5, Accounting for
Contingencies, we established reserves for tax contingencies that reflect our best estimate of the
transactions and deductions that we may be unable to sustain or that we could be willing to concede
as part of a broader tax settlement. We are currently undergoing routine tax
39
examinations by various state and foreign jurisdictions. Tax authorities periodically
challenge certain transactions and deductions we reported on our income tax returns. We do not
expect the outcome of these examinations, either individually or in the aggregate, to have a
material adverse effect on our financial position, results of operations, or cash flows.
It has been our companys practice to permanently reinvest all foreign earnings into foreign
operations and we currently expect to continue to reinvest foreign earnings permanently into our
foreign operations. Should we plan to repatriate any foreign earnings in the future, we will be
required to establish an income tax expense and related tax liability on such earnings.
Loss Contingencies
Due to the nature of our business, we may from time to time be subject to commercial disputes,
consumer product claims or various other lawsuits arising in the ordinary course of our business,
and we expect this will continue to be the case in the future. These lawsuits generally seek
damages, sometimes in substantial amounts, for commercial or personal injuries allegedly suffered
and can include claims for punitive or other special damages. In addition, we aggressively defend
our patent and other intellectual property rights. This often involves bringing infringement or
other commercial claims against third parties, which can be expensive and can results in
counterclaims against us. We are currently not a party to any material legal proceedings.
We do not accrue for potential losses on legal proceedings where our company is the defendant
when we are not able to reasonably estimate our potential liability, if any, due to uncertainty as
to the nature, extent and validity of the claims against us, uncertainty as to the nature and
extent of the damages or other relief sought by the plaintiff and the complexity of the issues
involved. Our potential liability, if any, in a particular case may become reasonably estimable
and probable as the case progresses, in which case we will begin accruing for the expected loss.
Recently Issued Accounting Standards
In February 2006, the Financial Accounting Standards Board (FASB) issued SFAS No. 155,
Accounting for Certain Hybrid Financial Instruments, which amends SFAS No. 133, Accounting for
Derivative Instruments and Hedging Activities and SFAS No. 140, Accounting for Transfers and
Servicing of Financial Assets and Extinguishments of Liabilities. SFAS No. 155 simplifies the
accounting for certain derivatives embedded in other financial instruments by allowing them to be
accounted for as a whole if the holder elects to account for the whole instrument on a fair value
basis. SFAS No. 155 also clarifies and amends certain other provisions of SFAS No. 133 and SFAS No.
140. SFAS No. 155 is effective for all financial instruments acquired, issued or subject to a
remeasurement event occurring in fiscal years beginning after September 15, 2006. Earlier adoption
is permitted, provided the Company has not yet issued financial statements, including for interim
periods, for that fiscal year. We do not expect the adoption of SFAS No. 155 to have a material
impact on our financial position, results of operations or cash flows.
In March 2006, the FASB issued SFAS No. 156, Accounting for Servicing of Financial Assets an
Amendment of FASB Statement No. 140. SFAS No. 156 requires that all separately recognized
servicing rights be initially measured at fair value, if practicable. In addition, this Statement
permits an entity to choose between two measurement methods (amortization method or fair value
measurement method) for each class of separately recognized servicing assets and liabilities. This
new accounting standard is effective January 1, 2007. The adoption of SFAS No. 156 is not expected
to have an impact on our financial position, results of operations or cash flows.
In June 2006, the FASB ratified the consensus on Emerging Issues Task Force (EITF) Issue No.
06-03, How Taxes Collected from Customers and Remitted to Governmental Authorities Should Be
Presented in the Income Statement. The scope of EITF Issue No. 06-03 includes any tax assessed by
a governmental authority that is directly imposed on a revenue-producing transaction between a
seller and a customer and may include, but is not limited to, sales, use, value added, Universal
Service Fund (USF) contributions and some excise taxes. The Task Force affirmed its conclusion
that entities should present these taxes in the income statement on either a gross or a net basis,
based on their accounting policy, which should be disclosed pursuant to APB Opinion No. 22,
Disclosure of Accounting Policies. If such taxes are significant, and are presented on a gross
basis, the amounts of those taxes should be disclosed. The consensus on Issue No. 06-03 will be
effective for interim and annual reporting periods beginning after December 15, 2006. We are
currently evaluating the manner in which we record gross receipts taxes, USF contributions and
miscellaneous other taxes and regulatory cost recovery fees. Should we need to change the manner
in which we record gross receipts, it is not expected that the change would have a material
impact on total operating revenue and expenses and operating income and net income would not be
affected.
In June 2006, the FASB issued FASB Interpretation No. (FIN) 48, Accounting for Uncertainty
in Income Taxes an Interpretation of FASB Statement No. 109. FIN 48 clarifies the accounting for
uncertainty in income taxes recognized in an enterprises financial statements in accordance with
FASB Statement No. 109, Accounting for Income Taxes. FIN 48 prescribes a recognition threshold and
measurement of a tax position taken or expected to be taken in a tax return. FIN 48 is effective
for fiscal years beginning after December 15, 2006. We are currently evaluating the impact of the
adoption of FIN 48 on our financial statements, but it is not expected to be material.
40
Recently Adopted Accounting Standards
In November 2004, the FASB issued SFAS No. 151, Inventory Costs an Amendment of ARB No. 43,
Chapter 4. SFAS No. 151 clarifies the accounting for abnormal amounts of idle facility expense,
freight, handling costs and wasted materials (spoilage). In addition, this statement requires that
allocation of fixed production overheads to the costs of conversion be based on normal capacity of
production facilities. As required by SFAS No. 151, we adopted this new accounting standard on
January 1, 2006. The adoption of SFAS No. 151 did not have a material impact on our financial
position, results of operations or cash flows.
In December 2004, the FASB issued SFAS No. 123-R, Share-Based Payment, which addresses the
accounting for transactions in which a company receives employee services in exchange for (a)
equity instruments of the company or (b) liabilities that are based on the fair value of the
companys equity instruments or that may be settled by the issuance of such equity instruments.
Under the original guidance of SFAS No. 123-R, we were to adopt the statements provisions for the
interim period beginning after June 15, 2005. However, in April 2005, as a result of an action by
the Securities and Exchange Commission, companies were allowed to adopt the provisions of SFAS No.
123-R at the beginning of their fiscal year that begins after June 15, 2005. Consequently, we
adopted SFAS No. 123-R on January 1, 2006. See Note 4 in our accompanying consolidated financial
statements for further discussion.
In May 2005, the FASB issued SFAS No. 154, Accounting Changes and Error Corrections, which
replaces APB Opinion No. 20, Accounting Changes, and SFAS No. 3, Reporting Accounting Changes in
Interim Financial Statements. The statement requires a voluntary change in accounting principle be
applied retrospectively to all prior period financial statements so that those financial statements
are presented as if the current accounting principle had always been applied. APB Opinion No. 20
previously required most voluntary changes in accounting principle to be recognized by including in
net income of the period of change the cumulative effect of changing to the new accounting
principle. In addition, SFAS No. 154 carries forward, without change, the guidance contained in APB
Opinion No. 20 for reporting a correction of an error in previously issued financial statements and
a change in accounting estimate. SFAS No. 154 was effective for accounting changes and corrections
of errors made after January 1, 2006. The adoption of SFAS No. 154 had no impact on our financial
statements.
SPECIAL STATEMENT REGARDING FORWARD-LOOKING STATEMENTS
This report contains forward-looking statements within the meaning of Section 27A of the
Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as
amended. You can identify these statements by forward-looking words such as may, could,
should, would, intend, will, expect, anticipate, believe, estimate, continue or
similar words. You should read statements that contain these words carefully because they discuss
our future expectations, contain projections of our future results of operations or of our
financial condition or state other forward-looking information. There may be events in the
future that we are not able to predict accurately or control and that may cause our actual results
to differ materially from the expectations we describe in our forward-looking statements. We
caution investors that all forward-looking statements involve risks and uncertainties, and actual
results may differ materially from those we discuss in this report. These differences may be the
result of various factors, including those factors described in Part I, Item 1A, Risk Factors, of
our Annual Report on Form 10-K for the fiscal year ending December 31, 2005 and other risk factors
identified herein or from time to time in our periodic filings with the SEC. Some important
factors that could cause our actual results to differ materially from those projected in any such
forward-looking statements are as follows:
|
|
|
economic factors, including inflation and fluctuations in
interest rates and foreign currency exchange rates, and the potential effect of such
fluctuations on revenues, expenses and resulting margins; |
|
|
|
|
competitive factors, including technological advances achieved
and patents attained by competitors and generic competition; |
|
|
|
|
domestic and foreign healthcare changes resulting in pricing
pressures, including the continued consolidation among healthcare providers, trends toward
managed care and healthcare cost containment and government laws and regulations relating
to sales and promotion, reimbursement and pricing generally; |
|
|
|
|
government laws and regulations affecting domestic and foreign
operations, including those relating to trade, monetary and fiscal policies, taxes, price
controls, regulatory approval of new products and licensing; |
|
|
|
|
manufacturing interruptions, delays or capacity constraints or
lack of availability of alternative sources for components for our products, including our
ability to successfully maintain relationships with suppliers, or to put in place
alternative suppliers on terms that are acceptable to us; |
41
|
|
|
difficulties inherent in product development or arising out of
ABIs subjection to the FDAs Application Integrity Policy, including the potential
inability to successfully continue technological innovation, complete clinical trials,
obtain regulatory approvals in the United States and abroad, gain and maintain market
approval of products and the possibility of encountering infringement claims by competitors
with respect to patent or other intellectual property rights which can preclude or delay
commercialization of a product; |
|
|
|
|
significant litigation adverse to us including product
liability claims, patent infringement claims and antitrust claims; |
|
|
|
|
our ability to comply with regulatory requirements, including
the outcome of the SECs ongoing investigation into the revenue recognition issues at our
Wampole subsidiary disclosed in June 2005 and the ongoing inquiry by the Federal Trade
Commission into our acquisition of certain assets from Acon Laboratories. |
|
|
|
|
product efficacy or safety concerns resulting in product
recalls or declining sales; |
|
|
|
|
the impact of business combinations and organizational
restructurings consistent with evolving business strategies; |
|
|
|
|
our ability to satisfy the financial covenants and other
conditions contained in the agreements governing our indebtedness; |
|
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|
|
our ability to obtain required financing on terms that are
acceptable to us; and |
|
|
|
|
the issuance of new or revised accounting standards by the
American Institute of Certified Public Accountants, the Financial Accounting Standards
Board, the Public Company Accounting Oversight Board or the SEC. |
The foregoing list sets forth many, but not all, of the factors that could impact upon our
ability to achieve results described in any forward-looking statements. Readers should not place
undue reliance on our forward-looking statements. Before you invest in our common stock, you
should be aware that the occurrence of the events described above and elsewhere in this report
could harm our business, prospects, operating results and financial condition. We do not undertake
any obligation to update any forward-looking statements as a result of future events or
developments.
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
The following discussion about our market risk disclosures involves forward-looking
statements. Actual results could differ materially from those discussed in the forward-looking
statements. We are exposed to market risk related to changes in interest rates and foreign currency
exchange rates. We do not use derivative financial instruments for speculative or trading purposes.
Interest Rate Risk
We are exposed to market risk from changes in interest rates primarily through our investing
and financing activities. In addition, our ability to finance future acquisition transactions or
fund working capital requirements may be impacted if we are not able to obtain appropriate
financing at acceptable rates.
Our investing strategy, to manage interest rate exposure, is to invest in short-term, highly
liquid investments. Our investment policy also requires investment in approved instruments with an
initial maximum allowable maturity of eighteen months and an average maturity of our portfolio that
should not exceed six months, with at least $500,000 cash available at all times. Currently, our
short-term investments are in money market funds with original maturities of 90 days or less. At
June 30, 2006, our short-term investments approximated market value.
At June 30, 2006, we had revolving lines of credit available to us of up to $155.0 million in
the aggregate under our primary senior credit facility, against which $99.0 million was
outstanding. We may repay any borrowings under the revolving lines of credit at any time but in no
event later than March 31, 2008. Borrowings under the revolving lines of credit bear interest at
either (i) the London Interbank Offered Rate, or LIBOR, as defined in the credit agreement, plus
applicable margins or, at our option, (ii) a floating index rate
(Index Rate), as defined in the agreement, plus
applicable margins. Applicable margins, if we choose to use the LIBOR
or the Index Rate, can range
from 2.75% to 3.75% or 1.50% to 2.50%, respectively, depending on the quarterly adjustments that
are based on our consolidated financial performance.
As
of June 30, 2006, the LIBOR and Index Rate applicable under our primary senior credit
facility for the revolving lines of credit were 8.88% and 10.50%, respectively, and for the U.S.
term loan were 9.13% and 10.5%, respectively. Assuming no
42
changes in our leverage ratio, which would affect the margin of the interest rate under the
senior credit agreement, the effect of interest rate fluctuations on outstanding borrowings under
the revolving lines of credit as of June 30, 2006 over the next twelve months is quantified and
summarized as follows (in thousands):
|
|
|
|
|
|
|
Interest Expense |
|
|
Increase |
Interest rates increase by 1 percentage point |
|
$ |
990 |
|
Interest rates increase by 2 percentage points |
|
$ |
1,980 |
|
Foreign Currency Risk
We face exposure to movements in foreign currency exchange rates whenever we, or any of our
subsidiaries, enter into transactions with third parties that are denominated in currencies other
than our, or its, functional currency. Intercompany transactions between entities that use
different functional currencies also expose us to foreign currency risk. During the three and six
months ended June 30, 2006, the net impact of foreign currency changes on transactions was a gain
of $5.0 million and $3.3 million, respectively. The foreign
currency gain in the three and six-month periods include the impact of a $5.5 million and $4.3 million gain, respectively, resulting
from the closure of our CDIL operation in Galway, Ireland. Generally, we do not use derivative
financial instruments or other financial instruments with original maturities in excess of three
months to hedge such economic exposures.
Gross margins of products we manufacture at our European plants and sell in U.S. Dollar are
also affected by foreign currency exchange rate movements. Our gross margin on total net product
sales was 34.2% for the three months ended June 30, 2006. If the U.S. Dollar had been stronger by
1%, 5% or 10%, compared to the actual rates during the three months ended June 30, 2006, our gross
margin on total net product sales would have been 34.3%, 34.6% and 35.1%, respectively. Our gross
margin on total net product sales was 36.7% for the six months ended June 30, 2006. If the U.S.
dollar had been stronger by 1%, 5% or 10%, compared to the actual rates during the six months ended
June 30, 2006, our gross margin on total net product sales would have been 36.8%, 37.2% and 37.8%,
respectively.
In addition, because a substantial portion of our earnings is generated by our foreign
subsidiaries, whose functional currencies are other than the U.S. Dollar (in which we report our
consolidated financial results), our earnings could be materially impacted by movements in foreign
currency exchange rates upon the translation of the earnings of such subsidiaries into the U.S.
Dollar. If the U.S. Dollar had been stronger by 1%, 5% or 10%, compared to the actual average
exchange rates used to translate the financial results of our foreign subsidiaries, our net revenue
and net loss would have been lower by approximately the following amounts (in thousands):
|
|
|
|
|
|
|
|
|
|
|
Approximate |
|
Approximate |
|
|
decrease in |
|
increase in |
|
|
net revenue |
|
net loss |
If, during the three months ended June
30, 2006, the U.S. dollar was stronger by: |
|
|
|
|
|
|
|
|
1%
|
|
$ |
425 |
|
|
$ |
7 |
|
5%
|
|
$ |
2,124 |
|
|
$ |
36 |
|
10%
|
|
$ |
4,247 |
|
|
$ |
71 |
|
|
|
|
|
|
|
|
|
|
|
|
Approximate |
|
Approximate |
|
|
decrease in |
|
increase in |
|
|
net revenue |
|
net loss |
If, during the six months ended June
30, 2006, the U.S. dollar was stronger by: |
|
|
|
|
|
|
|
|
1%
|
|
$ |
829 |
|
|
$ |
40 |
|
5%
|
|
$ |
4,145 |
|
|
$ |
200 |
|
10%
|
|
$ |
8,290 |
|
|
$ |
400 |
|
ITEM 4. CONTROLS AND PROCEDURES
Evaluation of Disclosure Controls and Procedures
Our management evaluated, with the participation of our Chief Executive Officer (CEO) and
Chief Financial Officer (CFO), the effectiveness of the design and operation of our companys
disclosure controls and procedures (as defined in Rules 13a 15(e) or 15d 15(e) under the
Securities Exchange Act of 1934, as amended) as of the end of the period covered by this Quarterly
Report on Form 10-Q. Based on this evaluation, our management, including the CEO and CFO,
concluded that our companys
43
disclosure controls and procedures were effective at that time. We and our management
understand nonetheless that controls and procedures, no matter how well designed and operated, can
provide only reasonable assurances of achieving the desired control objectives, and our management
necessarily was required to apply its judgment in evaluating and implementing possible controls and
procedures. In reaching their conclusions stated above regarding the effectiveness of our
disclosure controls and procedures, our CEO and CFO concluded that such disclosure controls and
procedures were effective as of such date at the reasonable assurance level.
Changes in Internal Control over Financial Reporting
There was no change in our internal control over financial reporting that occurred during the
period covered by this Quarterly Report on Form 10-Q that has materially affected, or is reasonably
likely to materially affect, our internal control over financial reporting.
PART II OTHER INFORMATION
ITEM 1A. RISK FACTORS
As we disclosed in our Current Report on Form 8-K filed on July 19, 2006, we have signed a
non-binding letter of intent with The Procter & Gamble Company to form a joint venture to develop
and market consumer diagnostic products. The detailed planning to reach a final agreement will
take several months and specifics of a potential agreement are not available. We cannot guaranty
that a definitive agreement will be reached or that the proposed joint venture will be consummated.
Any final agreement will be subject to certain closing conditions and applicable regulatory
approvals.
Otherwise, there have been no material changes from the Risk Factors previously disclosed in
Part I, Item 1A, Risk Factors, of our Annual Report on Form 10-K for the fiscal year ending
December 31, 2005, as supplemented by any material changes or additions to such risk factors
disclosed in Part II, Item 1A, Risk Factors, of any Quarterly Report on Form 10-Q filed
subsequent to the Annual Report on Form 10-K.
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
On April 28, 2006, pursuant to the terms of our recent acquisition of CLONDIAG chip
technologies GmbH, we issued 24,896 shares of common stock to CLONDIAG employees to settle existing
employee bonus arrangements. The issuance was conducted pursuant to an exemption from registration
afforded by Regulation S under the Securities Act of 1933, as amended.
On May 15, 2006, we issued 800 shares of common stock upon the exercise of warrants, for
aggregate proceeds to us of $10,832, pursuant to an exemption afforded by Section 4(2) of the
Securities Act of 1933, as amended.
On
June 20, 2006, we issued 25,000 shares of common stock as consideration for the acquisition
of all of the capital stock of Innovative Medical Devices BVBA, pursuant to an exemption afforded
by Section 4(2) of the Securities Act of 1933, as amended.
ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
At the annual meeting of stockholders of our company held on May 24, 2006, Carol R. Goldberg,
Alfred M. Zeien and Ron Zwanziger were re-elected as Class II directors of our company. The other
directors whose term of office continued after the meeting were: Robert P. Khederian, David Scott,
Ph.D., Peter Townsend, John A. Quelch, John F. Levy and Jerry McAleer, Ph.D.
The following table summarizes the votes for, against or withheld, as well as the number of
broker non-votes with regard to each matter voted upon:
Class: Common Shares
|
|
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|
|
|
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|
|
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|
|
|
|
|
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|
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|
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|
|
|
|
Broker Non- |
Matter |
|
For |
|
Against |
|
Withheld |
|
Votes |
Election of: |
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
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Carol R. Goldberg |
|
|
23,335,357 |
|
|
|
0 |
|
|
|
124,109 |
|
|
|
0 |
|
Alfred M. Zeien |
|
|
23,278,850 |
|
|
|
0 |
|
|
|
180,616 |
|
|
|
0 |
|
Ron Zwanziger |
|
|
22,326,298 |
|
|
|
0 |
|
|
|
133,168 |
|
|
|
0 |
|
44
ITEM 6. EXHIBITS
Exhibits:
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Exhibit No. |
|
Description |
*31.1
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Certification by Chief Executive Officer Pursuant to
Section 302 of the Sarbanes-Oxley Act of 2002 |
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*31.2
|
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Certification by Chief Financial Officer Pursuant to
Section 302 of the Sarbanes-Oxley Act of 2002 |
|
|
|
*32.1
|
|
Certification Pursuant to 18 U.S.C. Section 1350, as
Adopted Pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002 |
45
SIGNATURE
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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INVERNESS MEDICAL INNOVATIONS, INC. |
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Date: August 8, 2006
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/s/ Christopher J. Lindop
Christopher J. Lindop
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Chief Financial Officer and an authorized officer |
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46