e10vq
Table of Contents

 
 
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
 
FORM 10-Q
(Mark One)
     
þ   QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended September 30, 2010
OR
     
o   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
(ALERE LOGO)
ALERE INC.
(Exact name of registrant as specified in its charter)
     
DELAWARE
(State or other jurisdiction of
incorporation or organization)
  04-3565120
(I.R.S. Employer
Identification No.)
51 SAWYER ROAD, SUITE 200
WALTHAM, MASSACHUSETTS 02453

(Address of principal executive offices)(Zip code)
(781) 647-3900
(Registrant’s telephone number, including area code)
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Yes þ       No o
Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).
Yes þ       No o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act. (Check one):
             
Large accelerated filer þ
  Accelerated filer o   Non-accelerated filer o   Smaller reporting company o
 
      (Do not check if a smaller reporting company)    
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 registrant’s common stock, par value of $0.001 per share, as of November 1, 2010 was 84,848,054.
 
 

 


 

ALERE INC.
REPORT ON FORM 10-Q
For the Quarterly Period Ended September 30, 2010
     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. A number of important factors could cause actual results of Alere 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, as amended, for the fiscal year ended December 31, 2009 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 risk factors, 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 Alere Inc. and its subsidiaries.
TABLE OF CONTENTS
         
    PAGE
       
       
    3  
    4  
    5  
    6  
    40  
    53  
    56  
       
    56  
    56  
    56  
    57  
    58  
 EX-10.2
 EX-10.3
 EX-10.4
 EX-10.5
 EX-10.6
 EX-10.8
 EX-31.1
 EX-31.2
 EX-32.1
 EX-101 INSTANCE DOCUMENT
 EX-101 SCHEMA DOCUMENT
 EX-101 CALCULATION LINKBASE DOCUMENT
 EX-101 LABELS LINKBASE DOCUMENT
 EX-101 PRESENTATION LINKBASE DOCUMENT

2


Table of Contents

PART I — FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
ALERE INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited)
(in thousands, except per share amounts)
                                 
    Three Months Ended September 30,     Nine Months Ended September 30,  
    2010     2009     2010     2009  
Net product sales
  $ 363,433     $ 370,742     $ 1,063,549     $ 972,603  
Services revenue
    171,123       134,075       497,292       383,279  
 
                       
Net product sales and services revenue
    534,556       504,817       1,560,841       1,355,882  
License and royalty revenue
    4,123       7,848       16,052       20,588  
 
                       
Net revenue
    538,679       512,665       1,576,893       1,376,470  
 
                       
Cost of net product sales
    170,549       169,213       500,990       446,352  
Cost of services revenue
    80,782       61,209       238,991       172,123  
 
                       
Cost of net product sales and services revenue
    251,331       230,422       739,981       618,475  
Cost of license and royalty revenue
    1,802       1,946       5,411       5,352  
 
                       
Cost of net revenue
    253,133       232,368       745,392       623,827  
 
                       
Gross profit
    285,546       280,297       831,501       752,643  
 
                       
Operating expenses:
                               
Research and development
    32,434       27,720       96,187       80,811  
Sales and marketing
    125,606       116,280       369,016       316,880  
General and administrative
    96,131       86,447       284,155       247,377  
Gain on disposition
          (3,355 )           (3,355 )
 
                       
Operating income
    31,375       53,205       82,143       110,930  
Interest expense, including amortization of original issue discounts and deferred financing costs
    (34,180 )     (30,580 )     (100,921 )     (72,092 )
Other income (expense), net
    7,525       1,187       14,681       1,018  
 
                       
Income (loss) from continuing operations before provision (benefit) for income taxes
    4,720       23,812       (4,097 )     39,856  
Provision (benefit) for income taxes
    (167 )     6,001       (964 )     12,901  
 
                       
Income (loss) from continuing operations before equity earnings of unconsolidated entities, net of tax
    4,887       17,811       (3,133 )     26,955  
Equity earnings (losses) of unconsolidated entities, net of tax
    (62 )     2,059       8,195       5,539  
 
                       
Income from continuing operations
    4,825       19,870       5,062       32,494  
Income (loss) from discontinued operations, net of tax
    2       413       11,913       (1,100 )
 
                       
Net income
    4,827       20,283       16,975       31,394  
Less: Net income attributable to non-controlling interests
    1,494       141       1,167       465  
 
                       
Net income attributable to Alere Inc. and Subsidiaries
    3,333       20,142       15,808       30,929  
Preferred stock dividends
    (6,147 )     (5,843 )     (18,001 )     (17,056 )
 
                       
Net income (loss) available to common stockholders
  $ (2,814 )   $ 14,299     $ (2,193 )   $ 13,873  
 
                       
Basic net income (loss) per common share attributable to Alere Inc. and Subsidiaries:
                               
Income (loss) from continuing operations
  $ (0.03 )   $ 0.17     $ (0.17 )   $ 0.19  
Income (loss) from discontinued operations
          0.01       0.14       (0.01 )
 
                       
Net income (loss) per common share
  $ (0.03 )   $ 0.18     $ (0.03 )   $ 0.17  
 
                       
Diluted net income (loss) per common share attributable to Alere Inc. and Subsidiaries:
                               
Income (loss) from continuing operations
  $ (0.03 )   $ 0.17     $ (0.17 )   $ 0.18  
Income (loss) from discontinued operations
          0.01       0.14       (0.01 )
 
                       
Net income (loss) per common share
  $ (0.03 )   $ 0.17     $ (0.03 )   $ 0.17  
 
                       
 
                               
Weighted average shares-basic
    84,796       81,625       84,269       79,682  
 
                       
Weighted average shares-diluted
    84,796       83,418       84,269       81,110  
 
                       
The accompanying notes are an integral part of these consolidated financial statements.

3


Table of Contents

ALERE INC. AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
(unaudited)
(in thousands, except par value)
                 
    September 30,     December 31,  
    2010     2009  
ASSETS
               
Current assets:
               
Cash and cash equivalents
  $ 487,581     $ 492,773  
Restricted cash
    2,699       2,424  
Marketable securities
    5,684       947  
Accounts receivable, net of allowances of $16,474 and $12,462 at September 30, 2010 and December 31, 2009, respectively
    384,828       354,453  
Inventories, net
    262,466       221,539  
Deferred tax assets
    34,313       66,492  
Income tax receivable
    1,680       1,107  
Prepaid expenses and other current assets
    71,283       73,075  
Assets held for sale
          54,148  
 
           
Total current assets
    1,250,534       1,266,958  
Property, plant and equipment, net
    369,795       324,388  
Goodwill
    3,727,596       3,463,358  
Other intangible assets with indefinite lives
    66,603       43,644  
Finite-lived intangible assets, net
    1,708,260       1,686,427  
Deferred financing costs, net, and other non-current assets
    82,208       72,762  
Investments in unconsolidated entities
    62,297       63,965  
Marketable securities
    21,012       1,503  
Deferred tax assets
    22,418       20,987  
 
           
Total assets
  $ 7,310,723     $ 6,943,992  
 
           
 
               
LIABILITIES AND EQUITY
               
 
               
Current liabilities:
               
Current portion of long-term debt
  $ 15,030     $ 18,970  
Current portion of capital lease obligations
    1,833       899  
Accounts payable
    115,429       126,322  
Accrued expenses and other current liabilities
    303,154       279,732  
Payable to joint venture, net
    4,773       533  
Deferred gain on joint venture
    288,565        
Liabilities related to assets held for sale
          11,558  
 
           
Total current liabilities
    728,784       438,014  
 
           
Long-term liabilities:
               
Long-term debt, net of current portion
    2,381,153       2,128,515  
Capital lease obligations, net of current portion
    939       940  
Deferred tax liabilities
    427,485       442,049  
Deferred gain on joint venture
          288,767  
Other long-term liabilities
    125,973       116,818  
 
           
Total long-term liabilities
    2,935,550       2,977,089  
 
           
Commitments and contingencies (Note 17)
               
Redeemable non-controlling interest
    50,371        
 
           
Stockholders’ equity:
               
Series B preferred stock, $0.001 par value (liquidation preference: $826,184 at September 30, 2010 and $793,696 at December 31, 2009);
               
Authorized: 2,300 shares;
               
Issued and outstanding: 2,065 shares at September 30, 2010 and 1,984 shares at December 31, 2009
    712,392       694,427  
Common stock, $0.001 par value;
               
Authorized: 150,000 shares;
               
Issued and outstanding: 84,864 shares at September 30, 2010 and 83,567 at December 31, 2009
    85       84  
Additional paid-in capital
    3,229,310       3,195,372  
Accumulated deficit
    (344,066 )     (359,874 )
Accumulated other comprehensive loss
    (4,904 )     (2,454 )
 
           
Total stockholders’ equity
    3,592,817       3,527,555  
Non-controlling interests
    3,201       1,334  
 
           
Total equity
    3,596,018       3,528,889  
 
           
Total liabilities and equity
  $ 7,310,723     $ 6,943,992  
 
           
The accompanying notes are an integral part of these consolidated financial statements.

4


Table of Contents

ALERE INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited)
(in thousands)
                 
    Nine Months Ended September 30,  
    2010     2009  
Cash Flows from Operating Activities:
               
Net income
  $ 16,975     $ 31,394  
Income (loss) from discontinued operations, net of tax
    11,913       (1,100 )
 
           
Income from continuing operations
    5,062       32,494  
Adjustments to reconcile income from continuing operations to net cash provided by operating activities:
               
Non-cash interest expense related to amortization of original issue discounts and write-off of deferred financing costs
    10,284       6,461  
Depreciation and amortization
    275,507       224,408  
Non-cash stock-based compensation expense
    22,947       20,287  
Impairment of inventory
    712       838  
Impairment of long-lived assets
    618       3,181  
Loss on sale of fixed assets
    607       611  
Equity earnings of unconsolidated entities, net of tax
    (8,195 )     (5,539 )
Deferred income taxes
    (33,256 )     (10,621 )
Other non-cash items
    (1,378 )     1,069  
Changes in assets and liabilities, net of acquisitions:
               
Accounts receivable, net
    (2,553 )     (47,232 )
Inventories, net
    (29,107 )     (7,657 )
Prepaid expenses and other current assets
    6,752       3,456  
Accounts payable
    (19,423 )     19,531  
Accrued expenses and other current liabilities
    23,121       (10,670 )
Other non-current liabilities
    (21,984 )     10,306  
 
           
Net cash provided by continuing operations
    229,714       240,923  
Net cash provided by (used in) discontinued operations
    (390 )     4,376  
 
           
Net cash provided by operating activities
    229,324       245,299  
 
           
Cash Flows from Investing Activities:
               
Purchases of property, plant and equipment
    (68,457 )     (74,459 )
Proceeds from sale of property, plant and equipment
    642       672  
Cash paid for acquisitions and transaction costs, net of cash acquired
    (465,583 )     (397,467 )
Increase in marketable securities
    (17,887 )      
Net cash received from equity method investments
    10,835       12,003  
Increase in other assets
    (1,717 )     (5,056 )
 
           
Net cash used in continuing operations
    (542,167 )     (464,307 )
Net cash provided by (used in) discontinued operations
    63,446       (271 )
 
           
Net cash used in investing activities
    (478,721 )     (464,578 )
 
           
Cash Flows from Financing Activities:
               
Increase in restricted cash
    (280 )     (252 )
Cash paid for financing costs
    (9,590 )     (15,331 )
Proceeds from issuance of common stock, net of issuance costs
    17,839       15,539  
Proceeds on long-term debt
    400,000       631,176  
Repayment on long-term debt
    (7,313 )     (8,344 )
Net proceeds (repayments) from revolving lines-of-credit
    (146,985 )     (3,453 )
Excess tax benefit on exercised stock options
    1,300       2,152  
Principal payments of capital lease obligations
    (1,270 )     (640 )
Other
    (509 )     (115 )
 
           
Net cash provided by continuing operations
    253,192       620,732  
Net cash used in discontinued operations
          (8 )
 
           
Net cash provided by financing activities
    253,192       620,724  
 
           
Foreign exchange effect on cash and cash equivalents
    (8,987 )     13,102  
 
           
Net increase (decrease) in cash and cash equivalents
    (5,192 )     414,547  
Cash and cash equivalents, beginning of period
    492,773       141,324  
 
           
Cash and cash equivalents, end of period
  $ 487,581     $ 555,871  
 
           
The accompanying notes are an integral part of these consolidated financial statements.

5


Table of Contents

ALERE INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
(1) Basis of Presentation of Financial Information
     The accompanying consolidated financial statements of Alere Inc. 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, 2009 included information and footnotes necessary for such presentation and were included in our Annual Report on Form 10-K, as amended, filed with the Securities and Exchange Commission, or SEC, on April 16, 2010. 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, 2009.
     Certain reclassifications of prior period amounts have been made to conform to current period presentation. These reclassifications had no effect on net income or equity.
(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 September 30, 2010, 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):
                 
    September 30, 2010     December 31, 2009  
Raw materials
  $ 86,162     $ 62,397  
Work-in-process
    63,100       56,338  
Finished goods
    113,204       102,804  
 
           
 
  $ 262,466     $ 221,539  
 
           
(4) Stock-based Compensation
     We recorded stock-based compensation expense in our consolidated statements of operations for the three and nine months ended September 30, 2010 and 2009, respectively, as follows (in thousands):
                                 
    Three Months Ended September 30,     Nine Months Ended September 30,  
    2010     2009     2010     2009  
Cost of sales
  $ 589     $ 572     $ 1,390     $ 1,480  
Research and development
    1,543       1,419       5,415       3,740  
Sales and marketing
    1,181       1,079       3,094       2,958  
General and administrative
    3,950       4,732       13,048       12,109  
 
                       
 
    7,263       7,802       22,947       20,287  
Benefit for income taxes
    (1,295 )     (1,653 )     (4,633 )     (4,083 )
 
                       
Stock-based compensation, net of tax
  $ 5,968     $ 6,149     $ 18,314     $ 16,204  
 
                       

6


Table of Contents

ALERE 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 for the periods presented (in thousands, except per share data):
                                 
    Three Months Ended September 30,     Nine Months Ended September 30,  
    2010     2009     2010     2009  
Income from continuing operations
  $ 4,825     $ 19,870     $ 5,062     $ 32,494  
Less: Preferred stock dividends
    (6,147 )     (5,843 )     (18,001 )     (17,056 )
 
                       
Income (loss) from continuing operations attributable to common shares
    (1,322 )     14,027       (12,939 )     15,438  
Less: Net income attributable to non-controlling interest
    1,494       141       1,167       465  
 
                       
Income (loss) from continuing operations attributable to Alere Inc. and Subsidiaries
    (2,816 )     13,886       (14,106 )     14,973  
Income (loss) from discontinued operations
    2       413       11,913       (1,100 )
 
                       
Net income (loss) available to common stockholders
  $ (2,814 )   $ 14,299     $ (2,193 )   $ 13,873  
 
                       
                                 
    Three Months Ended September 30,     Nine Months Ended September 30,  
    2010     2009     2010     2009  
Weighted-average common shares outstanding — basic
    84,796       81,625       84,269       79,682  
Effect of dilutive securities:
                               
Stock options
          1,605             1,280  
Warrants
          188             148  
 
                       
Weighted-average common shares outstanding — diluted
    84,796       83,418       84,269       81,110  
 
                       
                                 
    Three Months Ended September 30,     Nine Months Ended September 30,  
    2010     2009     2010     2009  
Net income (loss) per common share — basic:
                               
Income (loss) from continuing operations attributable to Alere Inc. and Subsidiaries
  $ (0.03 )   $ 0.17     $ (0.17 )   $ 0.19  
Income (loss) from discontinued operations
          0.01       0.14       (0.01 )
 
                       
Net income (loss) per common share — basic
  $ (0.03 )   $ 0.18     $ (0.03 )   $ 0.17  
 
                       
 
                               
Net income (loss) per common share — diluted:
                               
Income (loss) from continuing operations attributable to Alere Inc. and Subsidiaries
  $ (0.03 )   $ 0.17     $ (0.17 )   $ 0.18  
Income (loss) from discontinued operations
          0.01       0.14       (0.01 )
 
                       
Net income (loss) per common share — diluted
  $ (0.03 )   $ 0.17     $ (0.03 )   $ 0.17  
 
                       
     For the three and nine-month periods ended September 30, 2010, anti-dilutive shares of 16,330,000 and 16,855,000, respectively, were excluded from the computations of diluted net income (loss) per common share. For the three and nine-month periods ended September 30, 2009, anti-dilutive shares of 15,198,000 and 14,753,000, respectively, were excluded from the computations of diluted net income (loss) per common share.
(6) Redeemable Non-controlling Interest
     We entered into a put arrangement as part of a shareholder agreement with respect to the common securities that represent the 21.25% non-controlling interest of a certain minority shareholder in Standard Diagnostics, Inc., or Standard Diagnostics. This put arrangement is exercisable at KRW 40,000 per share by the counterparty upon the occurrence of certain events which are outside of our control. As a result, this non-controlling interest is classified as mezzanine equity on our accompanying consolidated balance sheet as of September 30, 2010. The redeemable non-controlling interest was recorded at its fair value of KRW 57.9 billion, or $49.2 million, as of the consummation of the transaction on February 8, 2010. The fair value of the redeemable non-controlling interest was determined using both a market approach and an income approach which utilizes a discounted cash flow model including assumptions of projected revenue, expenses, capital expenditures, other costs and a discount rate appropriate for the risk of achieving the projected cash flows. The redeemable put arrangement has an estimated redemption price of KRW 65.4 billion, or $56.9 million, as of September 30, 2010. The redeemable non-controlling interest will be accreted to the redemption price, through equity, at the point at which the redemption becomes probable. In addition, if the put is exercised, we will incur a penalty in the amount of KRW 63.0 billion, or approximately $54.8 million at

7


Table of Contents

ALERE INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)

(unaudited)
September 30, 2010, which will be accounted for as compensation expense at the time of the exercise. On October 30, 2010, we entered into an agreement with this minority shareholder whereby we would purchase all of this shareholder’s remaining shares in Standard Diagnostics for a total purchase price of KRW 125.4 billion, or approximately $111.6 million at October 30, 2010. This share purchase transaction was completed on November 5, 2010, which included the termination of the put arrangement. We will account for KRW 65.4 billion, or approximately $58.2 million at November 5, 2010, of the transaction consideration as purchase price and KRW 60.0 billion, or approximately $53.4 million at November 5, 2010, as compensation expense as a result of the transition of the day-to-day management control of the business to us and the termination of the put arrangement.
(7) Preferred Stock
     As of September 30, 2010, we had 5.0 million shares of preferred stock, $0.001 par value, authorized, of which 2.3 million shares were designated as Series B Convertible Perpetual Preferred Stock, or Series B preferred stock. In connection with our acquisition of Matria Healthcare Inc., or Matria, we issued shares of the Series B preferred stock and have paid dividends to date in shares of Series B preferred stock. At September 30, 2010, there were 2.1 million shares of Series B preferred stock outstanding with a fair value of approximately $454.4 million.
     For the three and nine months ended September 30, 2010, Series B preferred stock dividends amounted to $6.1 million and $18.0 million, respectively, which reduced earnings available to common stockholders for purposes of calculating net income (loss) per common share for the three and nine months ended September 30, 2010 (Note 5). For the three and nine months ended September 30, 2009, Series B preferred stock dividends amounted to $5.8 million and $17.1 million, respectively, which reduced earnings available to common stockholders for purposes of calculating net income (loss) per common share for the three and nine months ended September 30, 2009 (Note 5). Payments have been made in shares of Series B preferred stock covering all dividend periods through September 30, 2010.
(8) Comprehensive Income
     The following table provides a reconciliation of net income reported in our consolidated financial statements to comprehensive income for the three and nine months ended September 30, 2010 and 2009 (in thousands):
                                 
    Three Months Ended September 30,     Nine Months Ended September 30,  
    2010     2009     2010     2009  
Net income attributable to Alere Inc. and subsidiaries
  $ 3,333     $ 20,142     $ 15,808     $ 30,929  
 
                       
Other comprehensive income (loss):
                               
Changes in cumulative translation adjustment
    45,260       7,106       (3,204 )     11,942  
Unrealized gains on available for sale securities
    404       374       452       539  
Unrealized gains (losses) on interest rate swaps
    497       (3,646 )     237       2,274  
Minimum pension liability adjustment
    (237 )     (14 )     65       30  
 
                       
Total other comprehensive income (loss)
    45,924       3,820       (2,450 )     14,785  
 
                       
Total comprehensive income
  $ 49,257     $ 23,962     $ 13,358     $ 45,714  
 
                       
     A summary of the changes in stockholders’ equity and non-controlling interest comprising total equity for the nine months ended September 30, 2010 and 2009 is provided below (in thousands):
                                                 
    Nine Months Ended September 30,  
    2010     2009  
    Total     Non-             Total     Non-        
    Stockholders’     controlling             Stockholders’     controlling        
    Equity     Interest     Total Equity     Equity     Interest     Total Equity  
Equity, beginning of period
  $ 3,527,555     $ 1,334     $ 3,528,889     $ 3,278,838     $ 869     $ 3,279,707  
Issuance of common stock and warrants in connection with acquisitions
    16,277             16,277       115,584             115,584  
Exercise of common stock options and shares issued under employee stock purchase plan
    17,839             17,839       15,539             15,539  
Preferred stock dividends
    (119 )           (119 )     (115 )           (115 )
Stock-based compensation related to grants of common stock options
    22,947             22,947       20,287             20,287  
Stock option income tax benefits
    452             452       2,836             2,836  

8


Table of Contents

ALERE INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)

(unaudited)
                                                 
    Nine Months Ended September 30,  
    2010     2009  
    Total     Non-             Total     Non-        
    Stockholders’     controlling             Stockholders’     controlling        
    Equity     Interest     Total Equity     Equity     Interest     Total Equity  
Non-controlling interest from acquisitions
    (5,492 )     1,864       (3,628 )                  
Redeemable non-controlling interest in subsidiaries’ income
          (1,164 )     (1,164 )                  
Net income
    15,808       1,167       16,975       30,929       465       31,394  
Total other comprehensive income (loss)
    (2,450 )           (2,450 )     14,785             14,785  
 
                                   
Equity, end of period
  $ 3,592,817     $ 3,201     $ 3,596,018     $ 3,478,683     $ 1,334     $ 3,480,017  
 
                                   
     A summary of the changes in redeemable non-controlling interest recorded in the mezzanine section of the balance sheet for the nine months ended September 30, 2010 is provided below:
         
    Nine Months Ended  
    September 30, 2010  
Redeemable non-controlling interest, beginning of period
  $  
Non-controlling interest from acquisitions
    49,207  
Adjustment to fair value through charge to income
    1,164  
 
     
Redeemable non-controlling interest, end of period
  $ 50,371  
 
     
(9) Business Combinations
     On January 1, 2009, we adopted a new accounting standard issued by the Financial Accounting Standards Board, or FASB, related to accounting for business combinations using the acquisition method of accounting. Acquisitions consummated prior to January 1, 2009 were accounted for in accordance with the previously applicable guidance. In accordance with the new accounting standard, we expensed $0.9 million and $6.9 million of acquisition-related costs during the three and nine months ended September 30, 2010, respectively, primarily in general and administrative expense. We expensed $5.1 million and $11.5 million of acquisition-related costs during the three and nine months ended September 30, 2009, respectively, in general and administrative expense. Included in the $11.5 million of expense during the nine months ended September 30, 2009, was $3.8 million of costs associated with acquisition-related activity for transactions not consummated prior to January 1, 2009.
     Our business acquisitions have historically been made at prices above the fair value of the acquired net assets, resulting in goodwill, based on our expectations of synergies of combining the businesses. These synergies include elimination of redundant facilities, functions and staffing; use of our existing commercial infrastructure to expand sales of the acquired businesses’ products; and use of the commercial infrastructure of the acquired businesses to cost-effectively expand product sales.
     Allocation of the purchase price for acquisitions is based on estimates of the fair value of the net assets acquired and, for acquisitions completed within the past year, is subject to adjustment upon finalization of the purchase price allocation. We are not aware of any information that indicates the final purchase price allocations will differ materially from the preliminary estimates. Determination of the estimated useful lives of the individual categories of intangible assets was based on the nature of the applicable intangible asset and the expected future cash flows to be derived from the intangible asset. Amortization of intangible assets with finite lives is recognized over the shorter of the respective lives of the agreement or the period of time the assets are expected to contribute to future cash flows. We amortize our finite-lived intangible assets on patterns in which the economic benefits are expected to be realized.
     (a) Acquisitions in 2010
     (i) Immunalysis
     On August 16, 2010, we acquired Diagnostixx of California, Corp. (d/b/a Immunalysis Corporation), or Immunalysis, located in Pomona, California, a privately-owned manufacturer and marketer of abused and prescription drug screening solutions used by clinical reference and forensic/crime laboratories. The preliminary aggregate purchase price was $53.2 million, which consisted of an initial cash payment totaling $52.0 million and a contingent consideration obligation of up to $5.0 million with an acquisition date fair value of $1.2 million. Included in our consolidated statements of operations for both the three and nine months ended September 30, 2010 is

9


Table of Contents

ALERE INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)

(unaudited)
revenue totaling approximately $2.5 million related to this acquired operation. The operating results of this acquired operation are included in our professional diagnostics reporting unit and business segment. We do not expect the amount allocated to goodwill to be deductible for tax purposes.
     (ii) A privately-owned U.K. research and development operation
     On March 11, 2010, we acquired a privately-owned U.K. research and development operation. The preliminary aggregate purchase price was $70.8 million, which consisted of an initial cash payment totaling $35.2 million and a contingent consideration obligation of up to $125.0 million with an acquisition date fair value of $35.6 million. Included in our consolidated statements of operations for both the three and nine months ended September 30, 2010 is revenue totaling approximately $0.1 million related to this acquired operation. The operating results of this acquired operation are included in our professional diagnostics reporting unit and business segment. We do not expect the amount allocated to goodwill to be deductible for tax purposes.
     (iii) The ATS business
     On February 17, 2010, we acquired Kroll Laboratory Specialists, Inc., headquartered in Gretna, Louisiana, which provides forensic quality substance abuse testing products and services across the United States. The preliminary aggregate purchase price was $109.5 million, which was paid in cash. Included in our consolidated statements of operations for the three and nine months ended September 30, 2010 is revenue totaling approximately $9.5 million and $23.8 million, respectively, related to the acquired business, which we have subsequently renamed Alere Toxicology Services, or ATS. The operating results of ATS are included in our professional diagnostics reporting unit and business segment. The amount allocated to goodwill from this acquisition is deductible for tax purposes.
     (iv) Standard Diagnostics
     On February 8, 2010, we acquired a 61.92% ownership interest in Standard Diagnostics via a tender offer for approximately $162.1 million. On March 22, 2010, we acquired an incremental 13.37% ownership interest in Standard Diagnostics via a follow-on tender offer for approximately $36.2 million. In June 2010, we acquired an incremental 2.84% ownership interest for approximately $7.3 million, bringing our acquisition-related aggregate ownership interest in Standard Diagnostics to approximately 78.13%. Standard Diagnostics specializes in the medical diagnostics industry. Its main product lines relate to diagnostic reagents and devices for hepatitis, infectious diseases, tumor markers, fertility, drugs of abuse, urine strips and protein strips. The preliminary aggregate purchase price was $205.6 million in cash. Included in our consolidated statements of operations for the three and nine months ended September 30, 2010 is revenue totaling approximately $24.9 million and $56.9 million, respectively, related to Standard Diagnostics. The operating results of Standard Diagnostics are included in our professional diagnostics reporting unit and business segment. We do not expect the amount allocated to goodwill to be deductible for tax purposes.
     (v) Other acquisitions in 2010
     During the first nine months of 2010, we acquired the following businesses for a preliminary aggregate purchase price of $83.1 million, which consisted of initial cash payments totaling $57.2 million, contingent consideration obligations with an acquisition date fair value of $25.3 million and deferred purchase price consideration with an acquisition date present value of $0.7 million.
    RMD Networks, Inc., or RMD, located in Denver, Colorado, a provider of clinical groupware software and services designed to improve communication and coordination of care among providers, patients, and payers in the healthcare environment (Acquired January 2010)
 
    certain assets of Streck, Inc., or Streck, located in Nebraska, a manufacturer of hematology, chemistry and immunology products for the clinical laboratory (Acquired January 2010)
 
    assets of the diagnostics division of Micropharm Ltd., or Micropharm, located in Wales, United Kingdom, an expert in high quality antibody production in sheep for both diagnostic and therapeutic purposes, providing antisera on a contract basis for U.K. and overseas companies and academic institutions, mainly for research, therapeutic and diagnostic uses (Acquired March 2010)

10


Table of Contents

ALERE INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)

(unaudited)
    Quantum Diagnostics Group Limited, or Quantum, headquartered in Essex, England, an independent provider of drug testing products and services to healthcare professionals across the U.K. and Europe (Acquired April 2010)
 
    assets of the workplace health division of Good Health Solutions Pty Ltd., or GHS, located in East Sydney, Australia, an important player in the Australian health and wellness market, focusing on health screenings, health related consulting services, health coaching and fitness instruction (Acquired April 2010)
 
    certain assets of Unotech Diagnostics, Inc., or Unotech, located in California, a privately-owned company engaged in the development, formulation, manufacture, packaging, supply and distribution of our BladderCheck NMP22 lateral flow test and related lateral flow products (Acquired June 2010)
 
    Scipac Holdings Limited, or Scipac, headquartered in Kent, England, a diagnostic reagent company with an extensive product portfolio supplying purified human antigens, recombinant proteins and disease state plasma to a global customer base (Acquired June 2010)
 
    a privately-owned research and development operation, located in San Diego, California (Acquired July 2010)
     The operating results of the acquired businesses mentioned above, except for RMD and GHS, are included in our professional diagnostics reporting unit and business segment. The operating results of RMD and GHS are included in our health management reporting unit and business segment. Our consolidated statements of operations for the three and nine months ended September 30, 2010 included revenue totaling approximately $5.3 million and $8.2 million, respectively, related to these businesses. Goodwill has been recognized in the acquisitions of RMD, Quantum, GHS, Scipac and the privately-owned research and development operation and amounted to approximately $48.5 million. We do not expect the goodwill related to these acquisitions to be deductible for tax purposes.
     A summary of the preliminary aggregate purchase price allocation for the acquisitions consummated in 2010 is as follows (in thousands):
                                                 
            Privately-                            
            owned U.K.                            
            research and                            
            development             Standard              
    Immunalysis     operation     ATS     Diagnostics     Other     Total  
Current assets
  $ 6,953     $ 374     $ 6,043     $ 52,057     $ 7,878     $ 73,305  
Property, plant and equipment
    1,092       152       3,300       18,580       3,858       26,982  
Goodwill
    15,174       61,463       53,489       35,462       48,480       214,068  
Intangible assets
    30,600       15,700       48,400       131,580       36,598       262,878  
Other non-current assets
                      13,342       68       13,410  
 
                                   
Total assets acquired
    53,819       77,689       111,232       251,021       96,882       590,643  
 
                                   
Current liabilities
    568       751       1,693       13,371       4,452       20,835  
Non-current liabilities
    50       6,107             32,088       9,339       47,584  
 
                                   
Total liabilities assumed
    618       6,858       1,693       45,459       13,791       68,419  
 
                                   
Net assets acquired
    53,201       70,831       109,539       205,562       83,091       522,224  
Less:
                                               
Contingent consideration
    1,200       35,600                   25,250       62,050  
Present value of deferred purchase price consideration
                            688       688  
 
                                   
Cash paid
  $ 52,001     $ 35,231     $ 109,539     $ 205,562     $ 57,153     $ 459,486  
 
                                   
     The following are the intangible assets acquired and their respective amortizable lives (dollars in thousands):

11


Table of Contents

ALERE INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)

(unaudited)
                                                     
            Privately-                                    
            owned U.K.                                    
            research and                                    
            development             Standard                     Amortizable
    Immunalysis     operation     ATS     Diagnostics     Other     Total     Life
Core technology and patents
  $ 8,800     $ 8,600     $ 13,300     $ 62,135     $ 8,750     $ 101,585     10 - 20 years
Quality systems
                            153       153     5 years
Database
                            654       654     3 years
Trademarks and trade names
    800                   9,350       731       10,881     3 - 7 years
License agreements
                            459       459     10 years
Customer relationships
    19,900             35,100       46,155       10,635       111,790     1 - 21.58 years
Non-compete agreements
    300                   255       733       1,288     1 - 5 years
Software
                            5,000       5,000     7 years
Distribution agreement
    800                               800     14 years
Manufacturing know-how
                            3,683       3,683     2 - 15 years
In-process research and development
          7,100             13,685       5,800       26,585     N/A
 
                                       
Total intangible assets
  $ 30,600     $ 15,700     $ 48,400     $ 131,580     $ 36,598     $ 262,878      
 
                                       
     (b) Acquisitions in 2009
     During the year ended December 31, 2009, we acquired the following businesses for a preliminary aggregate purchase price of $706.3 million ($702.4 million present value at September 30, 2010), which consisted of $476.4 million in cash; 3,430,435 shares of our common stock with an aggregate fair value of $117.5 million; $2.9 million of fair value associated with employee stock options exchanged as part of the transactions; deferred purchase price consideration payable in cash and common stock with an aggregate fair value of $57.9 million; notes payable totaling $7.9 million; warrants with a fair value of $0.1 million and contingent consideration obligations with an acquisition date fair value of $39.8 million.
    51.0% share in Long Chain International Corp., or Long Chain, located in Taipei, Taiwan, a distributor of point-of-care diagnostics testing products primarily to the Taiwanese marketplace (Acquired December 2009). In January 2010, we acquired the remaining 49.0% interest in Long Chain.
 
    Biolinker S.A., or Biolinker, located in Buenos Aires, Argentina, a distributor of point-of-care diagnostics testing products primarily to the Argentinean marketplace (Acquired December 2009)
 
    Jinsung Meditech, Inc., or JSM, located in Seoul, Korea, a distributor of point-of-care diagnostics testing products primarily to the South Korean marketplace (Acquired December 2009)
 
    Tapestry Medical, Inc., or Tapestry, located in Livermore, California, a privately-owned provider of products and related services designed to support anti-coagulation disease management for patients at risk for stroke and other clotting disorders (Acquired November 2009)
 
    Mologic Limited, or Mologic, located in Sharnbrook, United Kingdom, a research and development entity having wide immunoassay experience, as well as a broad understanding of medical diagnostic devices and antibody development (Acquired October 2009)
 
    Biosyn Diagnostics Limited, or Biosyn, located in Belfast, Ireland, a distributor of point-of-care diagnostics testing products primarily to the Irish marketplace (Acquired October 2009)
 
    Medim Schweiz GmbH, or Medim, located in Zug, Switzerland, a distributor of point-of-care diagnostics testing products primarily to the Swiss marketplace (Acquired September 2009)
 
    Free & Clear, Inc., or Free & Clear, located in Seattle, Washington, a privately-owned company that specializes in behavioral coaching to help employers, health plans and government agencies improve the overall health and productivity of their covered populations (Acquired September 2009)
 
    ZyCare, Inc., or ZyCare, located in Chapel Hill, North Carolina, a provider of technology and services used to help manage many chronic illnesses (Acquired August 2009)

12


Table of Contents

ALERE INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)

(unaudited)
    Concateno plc, or Concateno, a publicly-traded company headquartered in the United Kingdom that specializes in the manufacture and distribution of rapid drugs of abuse diagnostic products used in health care, criminal justice, workplace and other testing markets (Acquired August 2009)
 
    certain assets from CVS Caremark’s Accordant Common disease management programs, or Accordant, whereby chronically ill patients served by Accordant Common disease management programs are managed and have access to expanded offerings provided by our Alere Health business (Acquired August 2009)
 
    GeneCare Medical Genetics Center, Inc., or GeneCare, located in Chapel Hill, North Carolina, a medical genetics testing and counseling business (Acquired July 2009)
 
    assets of ACON Laboratories, Inc.’s and certain related entities’ business of researching, developing, manufacturing, distributing, marketing and selling lateral flow immunoassay and directly-related products in China, Asia Pacific, Latin America, South America, the Middle East, Africa, India, Pakistan, Russia and Eastern Europe (the “ACON Second Territory Business”) (Acquired April 2009)
     The operating results of Long Chain, Biolinker, JSM, Mologic, Biosyn, Medim, Concateno and the ACON Second Territory Business are included in our professional diagnostics reporting unit and business segment. The operating results of Tapestry, Free & Clear, ZyCare, Accordant and GeneCare are included in our health management reporting unit and business segment. Our consolidated statements of operations for the three and nine months ended September 30, 2010 included revenue totaling approximately $79.6 million and $232.7 million, respectively, related to these businesses. Our consolidated statements of operations for the three and nine months ended September 30, 2009 included revenue totaling approximately $31.9 million and $40.6 million, respectively, related to these businesses.
     A summary of the preliminary aggregate purchase price allocation for these acquisitions is as follows (dollars in thousands):
         
Current assets
  $ 87,085  
Property, plant and equipment
    13,018  
Goodwill
    397,445  
Intangible assets
    298,976  
Other non-current assets
    4,262  
 
     
Total assets acquired
    800,786  
 
     
Current liabilities
    40,805  
Non-current liabilities
    57,616  
 
     
Total liabilities assumed
    98,421  
 
     
Net assets acquired
    702,365  
Less:
       
Fair value of common stock issued (3,430,435 shares)
    117,476  
Fair value of stock options exchanged (315,227 options)
    2,881  
Fair value of warrants issued
    57  
Notes payable
    7,912  
Present value of deferred purchase price consideration
    57,853  
Fair value of contingent consideration obligation
    39,815  
 
     
Cash consideration
  $ 476,371  
 
     
     The following are the intangible assets acquired and their respective amortizable lives (dollars in thousands):
             
    Amount     Amortizable Life
Core technology
  $ 13,320     3-10 years
Trademarks and trade names
    33,753     2-20 years
Supplier relationships
    1,581     8 years
Customer relationships
    244,926     5.3-18.3 years
Non-compete agreements
    4,280     2-5 years
In-process research and development
    1,116     N/A
 
         
Total intangible assets
  $ 298,976      
 
         

13


Table of Contents

ALERE INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)

(unaudited)
     Goodwill has been recognized in all transactions and amounted to approximately $397.4 million. Goodwill related to the acquisitions of Tapestry, GeneCare and Accordant, which totaled $52.7 million, is expected to be deductible for tax purposes. Goodwill related to all other acquisitions is not deductible for tax purposes.
     (c) Restructuring Plans of Acquisitions
     In connection with several of our acquisitions consummated during 2008 and prior, we initiated integration plans to consolidate and restructure certain functions and operations, including the costs associated with the termination of certain personnel of these acquired entities and the closure of certain of the acquired entities’ leased facilities. These costs have been recognized as liabilities assumed in connection with the acquisition of these entities and are subject to potential adjustments as certain exit activities are refined. The following table summarizes the liabilities established for exit activities related to these acquisitions (in thousands):
                         
    Severance     Facility     Total Exit  
    Related     And Other     Activities  
Balance, December 31, 2009
  $ 5,369     $ 7,001     $ 12,370  
Restructuring plan accrual adjustments
    (2,167 )     (281 )     (2,448 )
Payments
    (2,832 )     (2,953 )     (5,785 )
 
                 
Balance, September 30, 2010
  $ 370     $ 3,767     $ 4,137  
 
                 
     In connection with our acquisition of Matria in May 2008, we implemented an integration plan to improve operating efficiencies and eliminate redundant costs resulting from the acquisition. The restructuring plan impacted all cost centers within the Matria organization, as activities were combined with our existing business operations. We recorded $18.5 million in exit costs, of which $13.8 million relates to change of control and severance costs to involuntarily terminate employees and $4.7 million related to facility exit costs. During the first and third quarters of 2010, we determined that $1.5 million in change of control costs and $0.2 million in facility exit costs would not be incurred, respectively, therefore reducing the assumed liability and goodwill related to the Matria acquisition by $1.7 million. As of September 30, 2010, $1.6 million in exit costs remain unpaid. See Note 10 for additional restructuring charges related to the Matria facility exit costs within the health management business segment.
     During 2007, we formulated restructuring plans in connection with our acquisition of Cholestech Corporation, or Cholestech, consistent with our acquisition strategy to realize operating efficiencies and cost savings. Additionally, in March 2008, we announced plans to close the Cholestech facility in Hayward, California. We have transitioned the manufacturing of the related products to our facility in San Diego, California and have transitioned the sales and distribution of the products to our shared services center in Orlando, Florida. Since inception of the plans, we recorded $8.6 million in exit costs, of which $5.9 million relates to executive change of control agreements and severance costs to involuntarily terminate employees and $2.7 million relates to facility exit costs. During the third quarter of 2010, we determined that $0.6 million in change of control and severance costs would not be incurred, therefore reducing the assumed liability and goodwill related to the Cholestech acquisition. As of September 30, 2010, $2.1 million in exit costs remain unpaid. See Note 10 for additional restructuring charges related to the Cholestech facility closure and integration.
     As a result of our acquisitions of Panbio Limited, or Panbio, Matritech, Inc. and Ostex International, Inc., or Ostex, we established plans to exit facilities and realize efficiencies and cost savings. Total costs associated with these plans were $6.4 million, of which $1.8 million related to severance costs and $4.6 million related to facility and exit costs. During the third quarter of 2010, upon settlement of our facility obligation under the Ostex acquisition, we determined that $0.1 million in facility exit costs would not be incurred, therefore reducing the assumed liability and goodwill related to that acquisition. As of September 30, 2010, $0.5 million in facility costs remain unpaid.
     Although we believe our plans and estimated exit costs for our acquisitions are reasonable, actual spending for exit activities may differ from current estimated exit costs.
     (d) Pro Forma Financial Information

14


Table of Contents

ALERE INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)

(unaudited)
     The following table presents selected unaudited financial information of our company, including the assets of the ACON Second Territory Business and Standard Diagnostics as if the acquisition of these entities had occurred on January 1, 2009. Pro forma results exclude adjustments for various other less significant acquisitions completed since January 1, 2009, 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 the periods presented and are not necessarily indicative of the results that would have occurred had the acquisitions been consummated on January 1, 2009 (in thousands, except per share amounts).
                                 
    Three Months Ended September 30,     Nine Months Ended September 30,  
    2010     2009     2010     2009  
Pro forma net revenue
  $ 538,679     $ 529,094     $ 1,583,046     $ 1,428,876  
 
                       
Pro forma net income (loss) from continuing operations attributable to Alere Inc. and Subsidiaries
  $ (2,636 )   $ 15,965     $ (10,117 )   $ 14,932  
 
                       
Pro forma net income (loss) available to common stockholders
  $ (2,634 )   $ 16,378     $ 1,797     $ 13,831  
 
                       
Pro forma net income (loss) from continuing operations attributable to Alere Inc. and Subsidiaries per common share — basic(1)
  $ (0.03 )   $ 0.20     $ (0.12 )   $ 0.18  
 
                       
Pro forma net income (loss) from continuing operations attributable to Alere Inc. and Subsidiaries per common share — diluted(1)
  $ (0.03 )   $ 0.19     $ (0.12 )   $ 0.18  
 
                       
Pro forma net income (loss) available to common stockholders —
basic(1)
  $ (0.03 )   $ 0.20     $ 0.02     $ 0.17  
 
                       
Pro forma net income (loss) available to common stockholders — diluted(1)
  $ (0.03 )   $ 0.20     $ 0.02     $ 0.17  
 
                       
 
(1)   Net income (loss) per common share amounts are computed as described in Note 5.
(10) Restructuring Plans
     The following table sets forth the aggregate charges associated with restructuring plans recorded in operating income for the three and nine months ended September 30, 2010 and 2009 (in thousands):
                                 
    Three Months Ended September 30,     Nine Months Ended September 30,  
    2010     2009     2010     2009  
Cost of net revenue
  $ (675 )   $ 2,582     $ 3,316     $ 6,141  
Research and development
    235       93       458       850  
Sales and marketing
    80       1,121       1,328       1,533  
General and administrative
    489       1,225       8,247       3,520  
 
                       
 
  $ 129     $ 5,021     $ 13,349     $ 12,044  
 
                       
     (a) 2010 Restructuring Plans
     In the first quarter of 2010, management developed additional plans to reduce costs and improve efficiencies in our health management business segment. As a result of these plans, we recorded $0.2 million and $6.4 million in charges during the three and nine months ended September 30, 2010, respectively. The charges for the three-month period included $0.1 million in facility exit costs and $0.1 million in present value accretion on facility exit costs. The charges for the nine-month period included $3.8 million in severance costs, $2.4 million in costs associated with facility exit costs and $0.2 million in present value accretion on facility exit costs, which was included in interest expense. As of September 30, 2010, $2.9 million in costs remains unpaid. We anticipate incurring additional restructuring costs associated with the present value accretion on facility exit costs under these plans.
     During the second quarter of 2010, management developed several plans to reduce costs and improve efficiencies in our professional diagnostics business segment. As a result of these plans, we recorded $0.6 million and $2.6 million in charges during the three and nine months ended September 30, 2010, respectively. The charges for the three-month period included $0.4 million in severance-related costs and $0.2 million in facility and other exit

15


Table of Contents

ALERE INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)

(unaudited)
costs. The charges for the nine-month period included $2.2 million in severance-related costs, $0.3 million in facility and other exit costs and $0.1 million in fixed asset impairments. As of September 30, 2010, $0.4 million of these costs remains unpaid. We anticipate incurring additional severance and facility exit costs of $0.7 million under these plans.
     (b) 2009 Restructuring Plans
     In 2009, management developed plans to reduce costs and improve efficiencies in our health management business segment, as well as reduce costs and consolidate operating activities among several of our professional diagnostics related German subsidiaries. As a result of these plans, we recorded $0.1 million and $0.4 million in severance-related restructuring charges in our professional diagnostics business segment during the three and nine months ended September 30, 2010, respectively. We recorded $2.4 million during both the three and nine months ended September 30, 2009, which included $2.1 million in severance costs, $0.2 million in contract cancellation costs and $0.1 million in present value accretion on facility exit costs. Of the $2.3 million included in operating income, $2.1 million and $0.2 million were included in our health management and professional diagnostics business segments, respectively. We have incurred $3.6 million since the inception of the plans, including $2.9 million in severance costs, $0.5 million in contract cancellation costs, $0.1 million in fixed asset impairment costs and $0.1 million in present value accretion on facility exit costs. Of the $3.5 million included in operating income, $2.3 million and $1.2 million were included in our health management and professional diagnostics business segments, respectively. We also recorded $0.1 million in present value accretion related to facility exit costs to interest expense during the three and nine months ended September 30, 2009. As of September 30, 2010, substantially all exit costs have been paid. We expect to incur an additional $0.2 million in facility exit costs under these plans during 2010, which will be included in our professional diagnostics business segment.
     (c) 2008 Restructuring Plans
     In May 2008, we decided to close our facility located in Bedford, England and initiated steps to cease operations at this facility and transition the manufacturing operations principally to our manufacturing facilities in Shanghai and Hangzhou, China. Based upon this decision, during the three and nine months ended September 30, 2010, we recorded net recoveries of $4.2 million and $1.4 million to restructuring, respectively. The $4.2 million net recovery included in the three-month period was primarily the result of a settlement of the facility restoration and other facility exit costs as a result of negotiations with the landlord of the Bedford facility. Of the net recovery recorded for the nine-month period, $0.1 million related to severance-related costs, $1.4 million related to transition costs, $0.4 million related to fixed asset and inventory write-offs and $3.3 million net recovery related to facility restoration and other facility exit costs. Of the $0.7 million net recovery and $1.9 million charge included in operating income for the three and nine months ended September 30, 2010, respectively, all was charged to our professional diagnostics business segment. Included in interest expense for the three and nine months ended September 30, 2010 were a net recovery of $0.1 million and a charge of $0.1 million related to the present value accretion of our facility restoration costs, respectively. We also recorded a net recovery of $3.4 million related to the facility lease obligation settlement during both the three and nine months ended September 30, 2010, to other income (expense), net.
     During the three months ended September 30, 2009, we recorded $1.0 million in restructuring charges, of which $0.3 million related primarily to severance-related costs, $0.6 million related to transition costs and $0.1 million related to the acceleration of facility restoration costs. During the nine months ended September 30, 2009, we recorded $3.3 million in restructuring charges, of which $1.7 million related primarily to severance-related costs, $0.5 million related to fixed asset impairments, $0.8 million related to transition costs and $0.3 million related to the acceleration of facility restoration costs. Of the $0.9 million included in operating income for the three months ended September 30, 2009, substantially all was charged to our professional diagnostics business segment. Of the $3.0 million included in operating income for the nine months ended September 30, 2009, $0.1 million and $2.9 million were charged to our consumer diagnostics and professional diagnostics business segments, respectively. We also recorded $0.1 million and $0.3 million during the three and nine months ended September 30, 2009, respectively, related to the accelerated present value accretion of our lease restoration costs due to the early termination of our facility lease, to interest expense.

16


Table of Contents

ALERE INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)

(unaudited)
     In addition to the restructuring charges discussed above, $3.5 million and $6.4 million of charges associated with the Bedford facility closure were borne by our 50/50 joint venture with P&G, or SPD, during the three and nine months ended September 30, 2010, respectively, and $1.9 million and $7.7 million were borne by SPD during the three and nine months ended September 30, 2009, respectively. The charges for the three months ended September 30, 2010 included $0.2 million in severance and retention costs, $2.9 million in facility and transition costs, $0.1 million in inventory write-offs and $0.3 million in acceleration of facility exit costs. The charges for the nine months ended September 30, 2010 included $1.5 million in severance and retention costs, $4.5 million in facility and transition costs, $0.1 million in inventory write-offs and $0.3 million in acceleration of facility exit costs. Of the total restructuring charges, 50%, or $1.7 million and $3.2 million, has been included in equity earnings of unconsolidated entities, net of tax, in our consolidated statements of operations for the three and nine months ended September 30, 2010, respectively. Included in the $1.9 million of charges recorded by SPD for the three months ended September 30, 2009 were $1.0 million in severance and retention costs, $0.4 million of fixed asset impairments, and $0.5 million in transition costs. Included in the $7.7 million of charges for the nine months ended September 30, 2009, was $6.2 million in severance and retention costs, $0.8 million of fixed asset and inventory impairments, $0.6 million in transition costs and $0.1 million in acceleration of facility exit costs. Of these restructuring charges, 50%, or $0.9 million and $3.9 million, has been included in equity earnings of unconsolidated entities, net of tax, in our consolidated statements of operations for the three and nine months ended September 30, 2009, respectively.
     Since inception of the plan, we have recorded $16.7 million in restructuring charges, including $4.0 million related to the acceleration of facility restoration costs, $5.9 million of fixed asset and inventory impairments, $4.0 million in severance costs, $0.7 million in early termination lease penalties and $2.7 million in transition costs as well as $0.6 million related to a pension plan curtailment gain associated with the Bedford employees being terminated. SPD has been allocated $31.3 million in restructuring charges since the inception of the plan, including $9.7 million of fixed asset and inventory impairments, $11.4 million in severance and retention costs, $2.9 million in early termination lease penalties, $6.7 million in facility exit costs and $0.6 million related to the acceleration of facility exit costs. Of the total exit costs, including the costs incurred by SPD under this plan, which consists of severance-related costs, lease penalties and restoration costs, $6.7 million remains unpaid as of September 30, 2010. We anticipate incurring additional costs of approximately $1.6 million related to the closure of this facility, including, but not limited to, transition costs and rent obligations which will terminate in September 2011. Of these additional anticipated costs, approximately $0.3 million will be borne by us and included primarily in our professional diagnostics business segment and approximately $1.4 million will be borne by SPD.
     Additionally, in 2008, we formulated business transition plans related to the closure of our Cholestech, HemoSense, Inc. and Panbio facilities. In connection with these plans, we incurred $0.1 million and $2.4 million in restructuring charges during the three and nine months ended September 30, 2010, respectively. Included in the charges for nine-month period were $0.2 million relates to severance and retention costs, $1.3 million in facility closure and transition costs, $0.8 million in fixed asset and inventory write-offs and $0.1 million in present value accretion of facility lease costs. During the nine months ended September 30, 2010, $2.3 million in charges was included in operating income of our professional diagnostics business segment. We charged $0.1 million, related to the present value accretion of facility lease costs, to interest expense for the three and nine months ended September 30, 2010. We incurred $1.5 million in restructuring charges during the three months ended September 30, 2009, including $0.1 million in severance and retention costs, $0.8 million in transition costs and $0.6 million in inventory write-offs. During the nine months ended September 30, 2009, we recorded $5.5 million in charges, including $2.0 million in fixed asset impairments, $1.3 million in severance and retention costs, $1.3 million in transition costs, $0.8 million in inventory write-offs and $0.1 million in present value accretion of facility lease costs. During the three and nine months ended September 30, 2009, respectively, $1.5 million and $5.4 million in charges were included in operating income of our professional diagnostics business segment. We charged $0.1 million, related to the present value accretion of facility lease costs, to interest expense for the nine months ended September 30, 2009. Since inception of the plans, we have incurred $14.3 million in restructuring charges, including $4.5 million in severance and retention costs, $3.4 million in fixed asset impairments, $4.5 million in transition costs, $1.5 million in inventory write-offs and $0.4 million in present value accretion of facility lease costs related to these plans. Of the $9.5 million in severance and exit costs, $0.7 million remains unpaid as of September 30, 2010. We anticipate incurring additional charges under our Cholestech plan, primarily related to facility exit costs and present value accretion of facility lease costs. See Note 9(c) for further information and costs related to these plans.

17


Table of Contents

ALERE INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)

(unaudited)
(11) Long-term Debt
     We had the following long-term debt balances outstanding (in thousands):
                 
    September 30, 2010     December 31, 2009  
First Lien Credit Agreement — Term loans
  $ 943,688     $ 951,000  
First Lien Credit Agreement — Revolving line of credit
          142,000  
Second Lien Credit Agreement
    250,000       250,000  
3% Senior subordinated convertible notes
    150,000       150,000  
9% Senior subordinated notes, net of original issue discount
    389,322       388,278  
7.875% Senior notes, net of original issue discount
    244,551       243,959  
8.625% Senior subordinated notes
    400,000        
Lines of credit
    1,291       2,902  
Other
    17,331       19,346  
 
           
 
    2,396,183       2,147,485  
Less: Current portion
    (15,030 )     (18,970 )
 
           
 
  $ 2,381,153     $ 2,128,515  
 
           
     Our First Lien Credit Agreement and our Second Lien Credit Agreement are collectively referred to as our secured credit facilities. Included in the secured credit facilities is a revolving line of credit of $150.0 million. Under the terms of our secured credit facilities, substantially all of the assets of our U.S. subsidiaries are pledged as collateral. With respect to shares or ownership interests of foreign subsidiaries owned by U.S. entities, we have pledged 66% of such assets.
     On September 21, 2010, we completed the sale of $400.0 million aggregate principal amount of the 8.625% senior subordinated notes due 2018, or the 8.625% subordinated notes, in a private placement to initial purchasers, who agreed to resell the notes only to qualified institutional buyers and to persons outside the United States. The proceeds are intended to be used for working capital and other general corporate purposes. At September 30, 2010, we had $400.0 million in indebtedness under our 8.625% subordinated notes.
     The 8.625% subordinated notes, which were issued under a supplemental indenture dated September 21, 2010, as amended or supplemented, the September 2010 Indenture, accrue interest from the date of their issuance, at the rate of 8.625% per year. Interest on the notes is payable semi-annually on April 1 and October 1, commencing on April 1, 2011. The notes mature on October 1, 2018, unless earlier redeemed.
     We may redeem the 8.625% subordinated notes, in whole or part, at any time (which may be more than once) on or after October 1, 2014, by paying the principal amount of the notes being redeemed plus a declining premium, plus accrued and unpaid interest to, but excluding, the redemption date. The premium declines from 4.313% during the twelve months on and after October 1, 2014 to 2.156% during the twelve months on and after October 1, 2015 to zero on and after October 1, 2016. Prior to October 1, 2013, we may redeem, in whole or part, at any time (which may be more than once), up to 35% of the aggregate principal amount of the 8.625% subordinated notes with money that we raise in certain equity offerings so long as (i) we pay 108.625% of the principal amount of the notes being redeemed, plus accrued and unpaid interest to (but excluding) the redemption date; (ii) we redeem the notes within 90 days of completing such equity offering; and (iii) at least 65% of the aggregate principal amount of the 8.625% subordinated notes, including any 8.625% subordinated notes issued after September 21, 2010, remains outstanding afterwards. In addition, at any time prior to October 1, 2014, we may redeem some or all of the 8.625% subordinated notes by paying the principal amount of the notes being redeemed plus the payment of a make-whole premium, plus accrued and unpaid interest to, but excluding, the redemption date.
     If a change of control occurs, subject to specified conditions, we must give holders of the 8.625% subordinated notes an opportunity to sell their notes to us at a purchase price of 101% of the principal amount of the notes, plus accrued and unpaid interest to, but excluding, the date of the purchase.
     If we or our subsidiaries engage in asset sales, we or they generally must either invest the net cash proceeds from such sales in our or their businesses within a specified period of time, repay senior indebtedness or make an

18


Table of Contents

ALERE INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)

(unaudited)
offer to purchase a principal amount of the 8.625% subordinated notes equal to the excess net cash proceeds, subject to certain exceptions. The purchase price of the notes will be 100% of their principal amount, plus accrued and unpaid interest.
     The 8.625% subordinated notes are unsecured and are subordinated in right of payment to all of our existing and future senior debt, including our borrowing under our secured credit facilities. Our obligations under the 8.625% subordinated notes and the September 2010 Indenture are fully and unconditionally guaranteed, jointly and severally, on an unsecured senior subordinated basis by certain of our domestic subsidiaries, and the obligations of such domestic subsidiaries under their guarantees are subordinated in right of payment to all of their existing and future senior debt. See Note 22 for guarantor financial information.
     The September 2010 Indenture contains covenants that will limit our ability and the ability of our subsidiaries to, among other things, incur additional debt; pay dividends on capital stock or redeem, repurchase or retire capital stock or subordinated debt; make certain investments; create liens on assets; transfer or sell assets; engage in transactions with affiliates; create restrictions on our or their ability to pay dividends or make loans, asset transfers or other payments to us or them; issue capital stock of our or their subsidiaries; engage in any business, other than our or their existing businesses and related businesses; enter into sale and leaseback transactions; incur layered indebtedness; and consolidate, merge or transfer all or substantially all of our or their assets, taken as a whole. These covenants are subject to certain exceptions and qualifications.
     In connection with our significant long-term debt issuances, we recorded interest expense, including amortization of deferred financing costs and original issue discounts, in our consolidated statements of operations for the three and nine months ended September 30, 2010 and 2009, respectively, as follows (in thousands):
                                 
    Three Months Ended September 30,     Nine Months Ended September 30,  
    2010     2009     2010     2009  
Secured credit facilities
  $ 15,818     $ 15,880     $ 47,314     $ 47,634  
3% Senior subordinated convertible notes
    1,205       1,248       3,696       3,743  
9% Senior subordinated notes
    9,914       10,001       29,417       15,236  
7.875% Senior notes
    5,462       1,878       16,030       1,878  
8.625% Senior subordinated notes
    972             972        
 
                       
 
  $ 33,371     $ 29,007     $ 97,429     $ 68,491  
 
                       
     In August 2007, we entered into interest rate swap contracts, with an effective date of September 28, 2007, that have a total notional value of $350.0 million and a maturity date of September 28, 2010. These interest rate swap contracts paid us variable interest at the three-month LIBOR rate, and we paid the counterparties a fixed rate of 4.85%. In March 2009, we extended our August 2007 interest rate hedge for an additional two-year period commencing in September 2010 at a one-month LIBOR rate of 2.54%. These interest rate swap contracts were entered into to convert $350.0 million of the $1.2 billion variable rate term loans under the secured credit facilities into fixed rate debt.
     In January 2009, we entered into interest rate swap contracts, with an effective date of January 14, 2009, that have a total notional value of $500.0 million and a maturity date of January 5, 2011. These interest rate swap contracts pay us variable interest at the one-month LIBOR rate, and we pay the counterparties a fixed rate of 1.195%. These interest rate swap contracts were entered into to convert $500.0 million of the $1.2 billion variable rate term loans under the secured credit facilities into fixed rate debt.
(12) Derivative Financial Instruments
     We use derivative financial instruments (interest rate swap contracts) in the management of our interest rate exposure related to our secured credit facilities. We do not hold or issue derivative financial instruments for speculative purposes.
     The following tables summarize the fair value of our derivative instruments and the effect of derivative instruments on/in our accompanying consolidated balance sheets and consolidated statements of operations and in accumulated other comprehensive loss (in thousands):

19


Table of Contents

ALERE INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)

(unaudited)
                     
        Fair Value at     Fair Value at  
Derivative Instruments   Balance Sheet Caption   September 30, 2010     December 31, 2009  
Interest rate swap contracts(1)
  Accrued expenses and other current liabilities   $ 1,232     $  
 
               
Interest rate swap contracts(1)
  Other long-term liabilities   $ 14,326     $ 15,945  
 
               
                     
        Amount of     Amount of  
        Gain Recognized     Loss Recognized  
        During the Three     During the Three  
        Months Ended     Months Ended  
Derivative Instruments   Location of Gain (Loss) Recognized in Income   September 30, 2010     September 30, 2009  
Interest rate swap contracts(1)
  Other comprehensive loss   $ 1,115     $ (3,646 )
 
               
                     
        Amount of Gain     Amount of  
        Recognized     Gain Recognized  
        During the Nine     During the Nine  
        Months Ended     Months Ended  
Derivative Instruments   Location of Gain Recognized in Income   September 30, 2010     September 30, 2009  
Interest rate swap contracts(1)
  Other comprehensive loss   $ 388     $ 2,274  
 
               
 
(1)   See Note 11 regarding our interest rate swaps which qualify as cash flow hedges.
(13) Fair Value Measurements
     We apply fair value measurement accounting to value our financial assets and liabilities. Fair value measurement accounting provides a framework for measuring fair value under U.S. GAAP and requires expanded disclosures regarding fair value measurements. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. A fair value hierarchy requires an entity to maximize the use of observable inputs, where available, and minimize the use of unobservable inputs when measuring fair value.
     Described below are the three levels of inputs that may be used to measure fair value:
Level 1     Quoted prices in active markets for identical assets or liabilities. Our Level 1 assets and liabilities include investments in marketable securities.
 
Level 2     Observable inputs other than Level 1 prices, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. Our Level 2 liabilities include interest rate swap contracts.
 
Level 3     Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. The fair value of the contingent consideration obligations related to our acquisitions completed after January 1, 2009 are valued using Level 3 inputs.
     The following tables present information about our assets and liabilities that are measured at fair value on a recurring basis as of September 30, 2010 and December 31, 2009, and indicate the fair value hierarchy of the valuation techniques we utilized to determine such fair value (in thousands):
                                 
            Quoted Prices in     Significant Other        
    September 30,     Active Markets     Observable Inputs     Unobservable Inputs  
Description   2010     (Level 1)     (Level 2)     (Level 3)  
Assets:
                               
Marketable securities
  $ 26,696     $ 26,696     $     $  
 
                       
Total assets
  $ 26,696     $ 26,696     $     $  
 
                       
Liabilities:
                               
Interest rate swap liability (1)
  $ 15,558     $     $ 15,558     $  
Contingent consideration obligations (2)
    101,392                   101,392  
 
                       
Total liabilities
  $ 116,950     $     $ 15,558     $ 101,392  
 
                       

20


Table of Contents

ALERE INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)

(unaudited)
                                 
            Quoted Prices in     Significant Other        
    December 31,     Active Markets     Observable Inputs     Unobservable Inputs  
Description   2009     (Level 1)     (Level 2)     (Level 3)  
Assets:
                               
Marketable securities
  $ 2,450     $ 2,450     $     $  
 
                       
Total assets
  $ 2,450     $ 2,450     $     $  
 
                       
Liabilities:
                               
Interest rate swap liability (1)
  $ 15,945     $     $ 15,945     $  
Contingent consideration obligations (2)
    43,178                   43,178  
 
                       
Total liabilities
  $ 59,123     $     $ 15,945     $ 43,178  
 
                       
 
(1)   The fair value of our interest rate swaps is based on the application of standard discounted cash flow models using market interest rate data. As of September 30, 2010, $1,232 was included in accrued expenses and other current liabilities and $14,326 was included in other long-term liabilities on our accompanying consolidated balance sheet. As of December 31, 2009, $15,945 was included in other long-term liabilities on our accompanying consolidated balance sheet.
 
(2)   The fair value measurement of the contingent consideration obligations related to the acquisitions completed after January 1, 2009 are valued using Level 3 inputs. We determine the fair value of the contingent consideration obligations based on a probability-weighted approach derived from earn-out criteria estimates and a probability assessment with respect to the likelihood of achieving the various earn-out criteria. The measurement is based upon significant inputs not observable in the market. Changes in the value of these contingent consideration obligations are recorded as income or expense, a component of operating income in our consolidated statement of operations. See Note 17 for additional information on the valuation of our contingent consideration obligations.
     Changes in the fair value of our Level 3 contingent consideration obligations during the nine months ended September 30, 2010 were as follows (in thousands):
         
Fair value of contingent consideration obligations, January 1, 2010
  $ 43,178  
Acquisition date fair value of contingent consideration obligations recorded
    60,743  
Payments
    (250 )
Adjustments, net (income) expense
    (2,279 )
 
     
Fair value of contingent consideration obligations, September 30, 2010
  $ 101,392  
 
     
     At September 30, 2010 and December 31, 2009, the carrying amounts of cash and cash equivalents, restricted cash, receivables, accounts payable and other current liabilities approximated their estimated fair values.
     The carrying amount and the estimated fair value of our long-term debt were $2.4 billion each at September 30, 2010. The carrying amount and the estimated fair value of our long-term debt were $2.1 billion each at December 31, 2009. The estimated fair value of our long-term debt was determined using market sources that were derived from available market information and may not be representative of actual values that could have been or will be realized in the future.
(14) 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 September 30,     Nine Months Ended September 30,  
    2010     2009     2010     2009  
Service cost
  $     $     $     $  
Interest cost
    158       156       469       439  
Expected return on plan assets
    (110 )     (115 )     (327 )     (324 )
Realized losses
                       
 
                       
Net periodic benefit cost
  $ 48     $ 41     $ 142     $ 115  
 
                       

21


Table of Contents

ALERE INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)

(unaudited)
(15) Financial Information by Segment
     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 Professional Diagnostics, Health Management, Consumer Diagnostics and Corporate and Other. Our operating results include license and royalty revenue which is allocated to Professional Diagnostics and Consumer Diagnostics on the basis of the original license or royalty agreement.
     On January 15, 2010, we completed the sale of our vitamins and nutritional supplements business (Note 20). The sale included our entire private label and branded nutritionals businesses and represents the complete divestiture of our entire vitamins and nutritional supplements business segment. The results of the vitamins and nutritional supplements business, which represents our entire vitamins and nutritional supplements business segment, are included in income (loss) from discontinued operations, net of tax, for all periods presented. The net assets and net liabilities associated with the vitamins and nutritional supplements business were reclassified to assets held for sale and liabilities related to assets held for sale within current assets and current liabilities, respectively, and were presented in Corporate and Other as of December 31, 2009.
     We evaluate performance of our operating segments based on revenue and operating income (loss). Segment information for the three and nine months ended September 30, 2010 and 2009 is as follows (in thousands):
                                         
                            Corporate    
    Professional   Health   Consumer   and    
    Diagnostics   Management   Diagnostics   Other   Total
Three months ended September 30, 2010:
                                       
Net revenue to external customers
  $ 363,519     $ 152,894     $ 22,266     $     $ 538,679  
Operating income (loss)
  $ 50,902     $ 74     $ 1,584     $ (21,185 )   $ 31,375  
Depreciation and amortization
  $ 61,328     $ 29,907     $ 960     $ 157     $ 92,352  
Restructuring charge
  $ 13     $ 123     $ (7 )   $     $ 129  
Stock-based compensation
  $     $     $     $ 7,263     $ 7,263  
Three months ended September 30, 2009:
                                       
Net revenue to external customers
  $ 340,617     $ 131,335     $ 40,713     $     $ 512,665  
Operating income (loss)
  $ 73,850     $ (1,688 )   $ 1,271     $ (20,228 )   $ 53,205  
Depreciation and amortization
  $ 48,821     $ 29,262     $ 1,583     $ 204     $ 79,870  
Restructuring charge
  $ 2,952     $ 2,116     $ (47 )   $     $ 5,021  
Stock-based compensation
  $     $     $     $ 7,802     $ 7,802  
Nine months ended September 30, 2010:
                                       
Net revenue to external customers
  $ 1,053,423     $ 451,182     $ 72,288     $     $ 1,576,893  
Operating income (loss)
  $ 135,333     $ (8,180 )   $ 5,421     $ (50,431 )   $ 82,143  
Depreciation and amortization
  $ 181,487     $ 89,955     $ 3,583     $ 482     $ 275,507  
Restructuring charge
  $ 7,128     $ 6,176     $ 45     $     $ 13,349  
Stock-based compensation
  $     $     $     $ 22,947     $ 22,947  
Nine months ended September 30, 2009:
                                       
Net revenue to external customers
  $ 893,618     $ 376,013     $ 106,839     $     $ 1,376,470  
Operating income (loss)
  $ 164,953     $ (3,185 )   $ (296 )   $ (50,542 )   $ 110,930  
Depreciation and amortization
  $ 133,878     $ 85,100     $ 4,792     $ 638     $ 224,408  
Restructuring charge
  $ 9,871     $ 2,116     $ 57     $     $ 12,044  
Stock-based compensation
  $     $     $     $ 20,287     $ 20,287  
Assets:
                                       
As of September 30, 2010
  $ 4,795,165     $ 1,998,345     $ 228,464     $ 288,749     $ 7,310,723  
As of December 31, 2009
  $ 4,261,716     $ 2,031,260     $ 219,647     $ 431,369     $ 6,943,992  
(16) Related Party Transactions
     In May 2007, we completed the formation of SPD, our 50/50 joint venture with P&G, for the development, manufacturing, marketing and sale of existing and to-be-developed consumer diagnostic products, outside the cardiology, diabetes and oral care fields. Upon completion of the arrangement to form SPD, we ceased to

22


Table of Contents

ALERE INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)

(unaudited)
consolidate the operating results of our consumer diagnostic products business related to SPD and instead account for our 50% interest in the results of SPD under the equity method of accounting.
     We had a net payable to SPD of $4.8 million and $0.5 million as of September 30, 2010 and December 31, 2009, respectively. Additionally, customer receivables associated with revenue earned after SPD was completed have been classified as other receivables within prepaid and other current assets on our accompanying consolidated balance sheets in the amount of $7.5 million and $12.3 million as of September 30, 2010 and December 31, 2009, respectively. In connection with the joint venture arrangement, SPD bears the collection risk associated with these receivables. Sales to SPD under our manufacturing agreement totaled $14.7 million and $49.4 million during the three and nine months ended September 30, 2010, respectively, and $31.2 million and $80.5 million during the three and nine months ended September 30, 2009, respectively. Additionally, services revenue generated pursuant to the long-term services agreement with SPD totaled $0.4 million and $0.9 million during the three and nine months ended September 30, 2010, respectively, and $0.5 million and $1.4 million during the three and nine months ended September 30, 2009, respectively. Sales under our manufacturing agreement and long-term services agreement are included in net product sales and services revenue, respectively, in our accompanying consolidated statements of operations.
     Under the terms of our product supply agreement, SPD purchases products from our manufacturing facilities in the U.K. and China. SPD in turn sells a portion of those tests back to us for final assembly and packaging. Once packaged, the tests are sold to P&G for distribution to third-party customers in North America. As a result of these related transactions, we have recorded $7.9 million and $14.5 million of trade receivables which are included in accounts receivable on our accompanying consolidated balance sheets as of September 30, 2010 and December 31, 2009, respectively, and $19.5 million and $23.2 million of trade accounts payable which are included in accounts payable on our accompanying consolidated balance sheets as of September 30, 2010 and December 31, 2009, respectively. During the nine months ended September 30, 2010 and 2009, we received $8.8 million and $10.0 million, respectively, in cash from SPD as a return of capital.
(17) Material Contingencies and Legal Settlements
     (a) Legal Proceedings
     Our material pending legal proceedings are described in Part I, Item 3, “Legal Proceedings” of our Annual Report on Form 10-K, as amended, for the year ended December 31, 2009, or the Form 10-K. We entered into a settlement related to the two intellectual property litigation matters relating to our health management businesses described in the Form 10-K and, on May 17, 2010, orders of dismissal were entered by the relevant Courts. During the nine months ended September 30, 2010, we recognized a net gain of approximately $5.3 million associated with this settlement in other income in our consolidated statements of operations.
     (b) Contingent Consideration Obligations
     Effective January 1, 2009, we adopted changes issued by the FASB to accounting for business combinations. These changes apply to all assets acquired and liabilities assumed in a business combination that arise from certain contingencies and require: (i) an acquirer to recognize at fair value, at the acquisition date, an asset acquired or liability assumed in a business combination that arises from a contingency if the acquisition-date fair value of that asset or liability can be determined during the measurement period; otherwise the asset or liability should be recognized at the acquisition date if certain defined criteria are met and (ii) contingent consideration arrangements of an acquiree assumed by the acquirer in a business combination be recognized initially at fair value.
     We determine the acquisition date fair value of the contingent consideration obligations based on a probability-weighted approach derived from the overall likelihood of achieving the targets before the corresponding delivery dates. The fair value measurement is based on significant inputs not observable in the market and thus represents a Level 3 measurement, as defined in fair value measurement accounting. The resultant probability-weighted milestone payments are discounted using a discount rate based upon the weighted-average cost of capital. At each reporting date, we revalue the contingent consideration obligations to the reporting date fair values and record increases and decreases in the fair values as income or expense in our consolidated statements of operations.

23


Table of Contents

ALERE INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)

(unaudited)
Increases or decreases in the fair values of the contingent consideration obligations may result from changes in discount periods and rates, changes in the timing and amount of earn-out criteria and changes in probability assumptions with respect to the likelihood of achieving the various earn-out criteria.
     The adoption of this guidance was done on a prospective basis. For acquisitions completed prior to January 1, 2009, contingent consideration will be accounted for as an increase in the aggregate purchase price and goodwill, if and when the contingencies occur.
     We have contractual contingent consideration terms related to our acquisitions of Accordant, Ameditech Inc., or Ameditech, Free & Clear, Immunalysis, a privately-owned research and development operation, JSM, Mologic, Tapestry, a privately-owned U.K. research and development operation, Vision Biotech Pty Ltd, or Vision, a privately-owned health management business acquired in 2008, and certain other small businesses.
     (i) Acquisitions Completed prior to January 1, 2009
      Ameditech
     With respect to Ameditech, the terms of the acquisition agreement require us to pay an earn-out upon successfully meeting certain revenue targets for the one-year period ending on the first anniversary of the acquisition date and the one-year period ending on the second anniversary of the acquisition date. As of September 30, 2010, the remaining contingent consideration to be earned is approximately $4.0 million.
      Privately-owned health management business
     With respect to a privately-owned health management business which we acquired in 2008, the terms of the acquisition agreement provide for contingent consideration payable upon successfully meeting certain revenue and EBITDA targets. The remaining contingent consideration to be earned will be payable upon meeting certain EBITDA targets for the year ending December 31, 2010.
      Vision
     With respect to Vision, the terms of the acquisition agreement provide for incremental consideration payable to the former Vision shareholders upon the completion of certain product development milestones and successfully maintaining certain production levels and product costs during each of the two years following the acquisition date, which was September 4, 2008. The final milestone totaling approximately $1.0 million was earned and paid during the third quarter of 2010. The achievement of this milestone was accounted for as an increase in the aggregate purchase price and goodwill during the third quarter of 2010.
     (ii) Acquisitions Completed on or after January 1, 2009
      Accordant
     With respect to Accordant, the terms of the acquisition agreement require us to pay an earn-out upon successfully meeting certain revenue and cash collection targets starting after the second anniversary of the acquisition date and completed prior to the third anniversary date of the acquisition. The maximum amount of the earn-out payment is $6.0 million and, if earned, payment will be made during 2012 and 2013. We recorded expense of approximately $0.2 million and $0.5 million within general and administrative expense in our consolidated statements of operations during the three and nine months ended September 30, 2010, respectively, as a net result of a decrease in the discount period and fluctuations in the discount rate since the acquisition date. As of September 30, 2010, the fair value of the contingent consideration obligation was approximately $3.9 million.
      Free & Clear
     With respect to Free & Clear, the terms of the acquisition agreement require us to pay an earn-out upon successfully meeting certain revenue and EBITDA targets during fiscal year 2010. The maximum amount of the earn-out payment is $30.0 million and, if earned, payment will be made in 2011. We recorded expense of

24


Table of Contents

ALERE INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)

(unaudited)
approximately $1.7 million and income of $3.7 million within general and administrative expense in our consolidated statements of operations during the three and nine months ended September 30, 2010, respectively, as a net result of changes to revenue and EBITDA estimates, changes in probability assumptions, a decrease in the discount period and fluctuations in the discount rate since the acquisition date. As of September 30, 2010, the fair value of the contingent consideration obligation was approximately $11.0 million.
      JSM
     With respect to JSM, the terms of the acquisition agreement require us to pay an earn-out upon successfully meeting certain revenue and operating income targets during each of the fiscal years 2010 through 2012. The maximum amount of the earn-out payments is approximately $3.0 million. We recorded income of approximately $46,000 and expense of $0.1 million within general and administrative expense in our consolidated statements of operations during the three and nine months ended September 30, 2010, respectively, as a net result of a decrease in the discount period, changes in probability assumptions and fluctuations in the discount rate since the acquisition date. As of September 30, 2010, the fair value of the contingent consideration obligation was approximately $1.1 million.
      Immunalysis
     With respect to Immunalysis, the terms of the acquisition agreement require us to pay earn-outs upon successfully meeting certain gross profit targets during each of the fiscal years 2010 through 2012. The maximum amount of the earn-out payments is $5.0 million. As of September 30, 2010, the fair value of the contingent consideration obligation was approximately $1.2 million.
     Additionally, we have a contractual contingent obligation to pay up to a total of $3.0 million in compensation to certain executives of Immunalysis in accordance with the acquisition agreement that, if earned, will be paid out in connection with the contingent consideration payable to the former shareholders of Immunalysis, in each of the calendar years 2010, 2011 and 2012.
     In no case, will the aggregate total of the two contingent obligations noted above exceed $6.0 million.
      Privately-owned research and development operation
     With respect to our acquisition of a privately-owned research and development operation, the terms of the acquisition agreement require us to pay earn-outs upon successfully meeting multiple product development related milestones during the five years following the acquisition. The maximum amount of the earn-out payments is $57.5 million. We recorded expense of approximately $0.6 million within general and administrative expense in our consolidated statements of operations during both the three and nine months ended September 30, 2010 as a net result of a decrease in the discount period and fluctuations in the discount rate since the acquisition date. As of September 30, 2010, the fair value of the contingent consideration obligation was approximately $25.1 million.
      Mologic
     With respect to Mologic, the terms of the acquisition agreement require us to pay earn-outs upon successfully meeting five R&D project milestones during the four years following the acquisition. The maximum amount of the earn-out payments is $19.0 million, which will be paid in shares of our common stock. We recorded expense of approximately $0.4 million and $0.2 million within general and administrative expense in our consolidated statements of operations during the three and nine months ended September 30, 2010, respectively, as a net result of a decrease in the discount period, adjustments to certain probability factors and fluctuations in the discount rate since the acquisition date. As of September 30, 2010, the fair value of the contingent consideration obligation was approximately $6.0 million.
      Privately-owned U.K. research and development operation
     With respect to our acquisition of a privately-owned U.K. research and development operation, the terms of the acquisition agreement require us to pay an earn-out upon successfully meeting certain revenue and product development targets. The

25


Table of Contents

ALERE INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)

(unaudited)
maximum amount of the earn-out payments is $125.0 million and, if earned, payments are expected to be made during the eight year period following the acquisition date, but could extend thereafter. We recorded expense of approximately $0.9 million and $2.3 million within general and administrative expense in our consolidated statements of operations during the three and nine months ended September 30, 2010, respectively, as a net result of a decrease in the discount period and fluctuations in the discount rate since the acquisition date. As of September 30, 2010, the fair value of the contingent consideration obligation was approximately $37.9 million.
      Tapestry
     With respect to Tapestry, the terms of the acquisition agreement require us to pay an earn-out upon successfully meeting certain revenue and EBITDA targets during each of the fiscal years 2010 and 2011. The maximum amount of the earn-out payments is $25.0 million which, if earned, will be paid in shares of our common stock, except in the case that the 2010 financial targets defined under the agreement and plan of merger are exceeded, in which case the seller may elect to be paid the 2010 earn-out in cash. If the seller elects to be paid in cash, the earn-out will be capped at $20.0 million. We recorded expense of approximately $0.8 million and income of $2.3 million within general and administrative expense in our consolidated statements of operations during the three and nine months ended September 30, 2010, respectively, as a net result of a decrease in the discount period, adjustments to certain probability factors and fluctuations in the discount rate since the acquisition date. As of September 30, 2010, the fair value of the contingent consideration obligation was approximately $14.4 million.
     (c) Contingent Obligations
      Agreements with Epocal
     In November 2009, we entered into a distribution agreement with Epocal, Inc., or Epocal, to distribute the epoc® Blood Analysis System for blood gas and electrolyte testing for $20.0 million, which is recorded on our accompanying consolidated balance sheet in other intangible assets, net. We also entered into a definitive agreement to acquire all of the issued and outstanding equity securities of Epocal for a total potential purchase price of up to $255.0 million, including a base purchase price of up to $172.5 million if Epocal achieves certain gross margin and other financial milestones on or prior to October 31, 2014, plus additional payments of up to $82.5 million if Epocal achieves certain other milestones relating to its gross margin and product development efforts on or prior to this date. We also agreed that, if the acquisition is consummated, we will provide $12.5 million in management incentive arrangements, 25% of which will vest over three years and 75% of which will be payable only upon the achievement of certain milestones. The acquisition will also be subject to other closing conditions, including the receipt of any required antitrust or other approvals.
      Option agreement with P&G
     In connection with the formation of SPD in May 2007, we entered into an option agreement with P&G, pursuant to which P&G has the right, for a period of 60 days commencing on the fourth anniversary date of the agreement, to require us to acquire all of P&G’s interest in SPD at fair market value, and P&G has the right, upon certain material breaches by us of our obligations to SPD, to acquire all of our interest in SPD at fair market value. No gain on the proceeds that we received from P&G through the formation of SPD will be recognized in our financial statements until P&G’s option to require us to purchase its interest in SPD expires. If P&G chooses to exercise its option, the deferred gain carried on our books would be reversed in connection with the repurchase transaction. As of September 30, 2010, the deferred gain of $288.6 million is presented as a current liability on our accompanying consolidated balance sheet. As of December 31, 2009, the deferred gain of $288.8 million is presented as a long-term liability.
      Put arrangement with minority shareholder in Standard Diagnostics
     We entered into a put arrangement as part of a shareholder agreement with respect to the common securities that represent the 21.25% non-controlling interest of a certain minority shareholder in Standard Diagnostics. This put arrangement is exercisable at KRW 40,000 per share by the counterparty upon the occurrence of certain events which are outside of our control. As a result, this non-controlling interest is classified as mezzanine equity on our accompanying consolidated balance sheet as of September 30, 2010. The redeemable non-controlling interest was

26


Table of Contents

ALERE INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)

(unaudited)
recorded at its fair value of KRW 57.9 billion, or $49.2 million, as of the consummation of the transaction on February 8, 2010. The redeemable put arrangement has an estimated redemption price of KRW 65.4 billion, or $56.9 million, as of September 30, 2010. The redeemable non-controlling interest will be accreted to the redemption price, through equity, at the point at which the redemption becomes probable. In addition, if the put is exercised, we will incur a penalty in the amount of KRW 63.0 billion, or approximately $54.8 million at September 30, 2010, which will be accounted for as compensation expense at the time of exercise. On October 30, 2010, we entered into an agreement with this minority shareholder whereby we would purchase all of this shareholder’s remaining shares in Standard Diagnostics for a total purchase price of KRW 125.4 billion, or approximately $111.6 million at October 30, 2010. This share purchase transaction was completed on November 5, 2010, which included the termination of the put arrangement. We will account for KRW 65.4 billion, or approximately $58.2 million at November 5, 2010, of the transaction consideration as purchase price and KRW 60.0 billion, or approximately $53.4 million at November 5, 2010, as compensation expense as a result of the transition of the day-to-day management control of the business to us and the termination of the put arrangement.
(18) Recent Accounting Pronouncements
Recently Issued Standards
     In April 2010, the FASB issued Accounting Standards Update, or ASU, No. 2010-17, Revenue Recognition — Milestone Method (Topic 605): Milestone Method of Revenue Recognition, or ASU 2010-17. ASU 2010-17 allows the milestone method as an acceptable revenue recognition methodology when an arrangement includes substantive milestones. ASU 2010-17 provides a definition of substantive milestone and should be applied regardless of whether the arrangement includes single or multiple deliverables or units of accounting. ASU 2010-17 is limited to transactions involving milestones relating to research and development deliverables. ASU 2010-17 also includes enhanced disclosure requirements about each arrangement, individual milestones and related contingent consideration, information about substantive milestones and factors considered in the determination. ASU 2010-17 is effective on a prospective basis for milestones achieved in fiscal years, and interim periods within those years, beginning on or after June 15, 2010, with early adoption permitted. We are currently evaluating the potential impact of this standard.
     In April 2010, the FASB issued ASU No. 2010-13, Compensation — Stock Compensation (Topic 718): Effect of Denominating the Exercise Price of a Share-Based Payment Award in the Currency of the Market in Which the Underlying Equity Security Trades, or ASU 2010-13. ASU 2010-13 clarifies that a share-based payment award with an exercise price denominated in the currency of a market in which a substantial portion of the entity’s equity securities trades should not be considered to contain a condition that is not a market, performance, or service condition. Therefore, such an award should not be classified as a liability if it otherwise qualifies as equity. ASU 2010-13 is effective for fiscal years, and interim periods within those fiscal years, beginning on or after December 15, 2010, with early adoption permitted. We are currently evaluating the potential impact of this standard.
     In October 2009, the FASB issued ASU No. 2009-14, Software (Topic 985): Certain Revenue Arrangements That Include Software Elements — a consensus of the FASB EITF, or ASU 2009-14. ASU 2009-14 changes the accounting model for revenue arrangements that include tangible products and software elements. The amendments of this update provide additional guidance on how to determine which software, if any, relating to the tangible product also would be excluded from the scope of the software revenue recognition guidance. The amendments in this update also provide guidance on how a vendor should allocate arrangement consideration to deliverables in an arrangement that includes both tangible products and software, as well as arrangements that have deliverables both included and excluded from the scope of software revenue recognition guidance. This standard is effective prospectively for revenue arrangements entered into or materially modified in fiscal years beginning on or after June 15, 2010. We are currently evaluating the potential impact of this standard.
     In October 2009, the FASB issued ASU No. 2009-13, Revenue Recognition (Topic 605): Multiple-Deliverable Revenue Arrangements — a consensus of the FASB EITF, or ASU 2009-13. ASU 2009-13 will separate multiple-deliverable revenue arrangements. This update establishes a selling price hierarchy for determining the selling price of a deliverable. The amendments of this update will replace the term “fair value” in the revenue allocation guidance with “selling price” to clarify that the allocation of revenue is based on entity-specific assumptions rather than assumptions of a marketplace participant. The amendments of this update will eliminate the residual method of allocation and require that arrangement consideration be allocated at the inception of the arrangement to all deliverables using the relative selling price method. The amendments in this update will require that a vendor determine its best estimated selling price in a manner consistent with that used to determine the price to sell the

27


Table of Contents

ALERE INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)

(unaudited)
deliverable on a standalone basis. This standard is effective prospectively for revenue arrangements entered into or materially modified in fiscal years beginning on or after June 15, 2010. We are currently evaluating the potential impact of this standard.
Recently Adopted Standards
     Effective July 1, 2010, we adopted ASU No. 2010-11, Derivatives and Hedging (Topic 815): Scope Exception Related to Credit Derivatives, or ASU 2010-11. ASU 2010-11 clarifies that embedded credit-derivative features related only to the transfer of credit risk in the form of subordination of one financial instrument to another are not subject to potential bifurcation and separate accounting. ASU 2010-11 also provides guidance on whether embedded credit-derivative features in financial instruments issued by structures such as collateralized debt obligations are subject to bifurcations and separate accounting. The adoption of this standard did not have an impact on our financial position, results of operations or cash flows.
     Effective January 1, 2010, we adopted ASU No. 2010-06, Fair Value Measurements and Disclosures (Topic 820): Improving Disclosures about Fair Value Measurements, or ASU 2010-06. A reporting entity should provide additional disclosures about the different classes of assets and liabilities measured at fair value, the valuation techniques and inputs used, the activity in Level 3 fair value measurements, and the transfers between Levels 1, 2, and 3 fair value measurements. The adoption of the additional disclosures for Level 1 and Level 2 fair value measurements did not have an impact on our financial position, results of operations or cash flows. The disclosures regarding Level 3 fair value measurements do not become effective until January 1, 2011 and, given such, we are currently evaluating the potential impact of this part of the update.
     Effective January 1, 2010, we adopted ASU No. 2010-01, Equity (Topic 505): Accounting for Distributions to Shareholders with Components of Stock and Cash (A Consensus of the FASB Emerging Issues Task Force), or ASU 2010-01. The amendments in this update clarify that the stock portion of a distribution to shareholders that allows them to elect to receive cash or stock with a potential limitation on the total amount of cash that all shareholders can elect to receive in the aggregate is considered a share issuance that is reflected in earnings per share prospectively and is not a stock dividend for purposes of applying Topics 505 and 260 (Equity and Earnings Per Share). Those distributions should be accounted for and included in earnings per share calculations. The adoption of this standard did not have an impact on our financial position, results of operations or cash flows.
     Effective January 1, 2010, we adopted ASU No. 2009-17, Consolidations (Topic 810): Improvements to Financial Reporting by Enterprises Involved with Variable Interest Entities, or ASU 2009-17. The amendments in this update replace the quantitative-based risks and rewards calculation for determining which reporting entity, if any, has a controlling financial interest in a variable interest entity with an approach focused on identifying which reporting entity has the power to direct the activities of a variable interest entity that most significantly impact the entity’s economic performance and (1) the obligation to absorb losses of the entity or (2) the right to receive benefits from the entity. An approach that is expected to be primarily qualitative will be more effective for identifying which reporting entity has a controlling financial interest in a variable interest entity. The amendments in this update also require additional disclosures about a reporting entity’s involvement in variable interest entities, which will enhance the information provided to users of financial statements. We evaluated our business relationships to identify potential variable interest entities and have concluded that consolidation of such entities is not required for the periods presented. On a quarterly basis, we will continue to reassess our involvement with variable interest entities.
     Effective January 1, 2010, we adopted ASU No. 2009-16, Transfers and Servicing (Topic 860): Accounting for Transfers of Financial Assets, or ASU 2009-16. The amendments in this update improve financial reporting by eliminating the exceptions for qualifying special-purpose entities from the consolidation guidance and the exception that permitted sale accounting for certain mortgage securitizations when a transferor has not surrendered control over the transferred financial assets. In addition, the amendments require enhanced disclosures about the risks that a transferor continues to be exposed to because of its continuing involvement in transferred financial assets. Comparability and consistency in accounting for transferred financial assets will also be improved through clarifications of the requirements for isolation and limitations on portions of financial assets that are eligible for sale accounting. The adoption of this standard did not have an impact on our financial position, results of operations or cash flows.
     Effective January 1, 2010, we adopted ASU No. 2009-15, Accounting for Own-Share Lending Arrangements in Contemplation of Convertible Debt Issuance or Other Financing, or ASU 2009-15. ASU 2009-15 provides guidance

28


Table of Contents

ALERE INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)

(unaudited)
on equity-classified share-lending arrangements on an entity’s own shares when executed in contemplation of a convertible debt offering or other financing. The adoption of this standard did not have an impact on our financial position, results of operations or cash flows.
(19) Equity Investments
     We account for the results from our equity investments under the equity method of accounting in accordance with ASC 323, Investments — Equity Method and Joint Ventures, based on the percentage of our ownership interest in the business. Our equity investments primarily include the following:
     (i) SPD
     In May 2007, we completed the formation of SPD, our 50/50 joint venture with P&G for the development, manufacturing, marketing and sale of existing and to-be-developed consumer diagnostic products, outside the cardiology, diabetes and oral care fields. Upon completion of the arrangement to form SPD, we ceased to consolidate the operating results of our consumer diagnostics business related to SPD. We recorded earnings of $(0.4) million and $6.8 million during the three and nine months ended September 30, 2010, respectively, and we recorded earnings of $1.6 million and $4.0 million during the three and nine months ended September 30, 2009, respectively, in equity earnings of unconsolidated entities, net of tax, in our accompanying consolidated statements of operations, which represented our 50% share of SPD’s net income for the respective periods.
     (ii) TechLab
     In May 2006, we acquired 49% of TechLab, Inc., or 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. We recorded earnings of $0.4 million and $1.4 million during the three and nine months ended September 30, 2010, respectively, and we recorded earnings of $0.5 million and $1.5 million during the three and nine months ended September 30, 2009, respectively, in equity earnings of unconsolidated entities, net of tax, in our accompanying consolidated statements of operations, which represented our minority share of TechLab’s net income for the respective periods.
     Summarized financial information for SPD and TechLab on a combined basis is as follows (in thousands):
Combined Condensed Results of Operations:
                                 
    Three Months Ended September 30,     Nine Months Ended September 30,  
    2010     2009     2010     2009  
Net revenue
  $ 54,014     $ 55,077     $ 168,876     $ 148,064  
 
                       
Gross profit
  $ 31,182     $ 31,481     $ 101,024     $ 96,234  
 
                       
Net income after taxes
  $ (281 )   $ 4,082     $ 16,393     $ 10,896  
 
                       
Combined Condensed Balance Sheets:
                 
    September 30, 2010     December 31, 2009  
Current assets
  $ 89,145     $ 87,880  
Non-current assets
    25,949       26,881  
 
           
Total assets
  $ 115,094     $ 114,761  
 
           
Current liabilities
  $ 62,069     $ 61,959  
Non-current liabilities
    1,749       1,492  
 
           
Total liabilities
  $ 63,818     $ 63,451  
 
           
(20) Discontinued Operations
     On January 15, 2010, we completed the sale of our vitamins and nutritional supplements business for a purchase price of approximately $63.4 million in cash, subject to the finalization of a working capital adjustment. The sale included our entire private label and branded nutritionals businesses and represents the complete divestiture of our entire vitamins and nutritional supplements business segment. We recognized a gain of approximately $19.6 million

29


Table of Contents

ALERE INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)

(unaudited)
($12.0 million, net of tax) in the first quarter of 2010. The results of the vitamins and nutritional supplements business, which represents our entire vitamins and nutritional supplements business segment, are included in income (loss) from discontinued operations, net of tax, for all periods presented. The net assets and net liabilities associated with the vitamins and nutritional supplements business were classified as assets held for sale and liabilities related to assets held for sale as of December 31, 2009.
     The following assets and liabilities have been segregated and classified as assets held for sale and liabilities related to assets held for sale, as appropriate, in the consolidated balance sheet as of December 31, 2009. The amounts presented below were adjusted to exclude cash, intercompany receivables and payables and certain assets and liabilities between the business held for sale and our company, which were excluded from the transaction (amounts in thousands).
         
    December 31, 2009  
Assets
       
Accounts receivable, net of allowances of $2,919 at December 31, 2009
  $ 21,100  
Inventories, net
    21,500  
Prepaid expenses and other current assets
    160  
Property, plant and equipment, net
    8,368  
Goodwill
    200  
Other intangible assets with indefinite lives
    135  
Other intangible assets, net
    2,581  
Other non-current assets
    104  
 
     
Total assets held for sale
  $ 54,148  
 
     
Liabilities
       
Accounts payable
  $ 8,299  
Accrued expenses and other current liabilities
    3,230  
Other long-term liabilities
    29  
 
     
Total liabilities related to assets held for sale
  $ 11,558  
 
     
     The following summarized financial information related to the vitamins and nutritionals supplements businesses have been segregated from continuing operations and reported as discontinued operations (amounts in thousands).
                                 
    Three Months Ended September 30,     Nine Months Ended September 30,  
    2010     2009     2010     2009  
Net revenue
  $     $ 23,145     $ 4,362     $ 63,590  
 
                       
Income (loss) from discontinued operations before income taxes
  $ (40 )   $ 665     $ 19,227     $ (2,074 )
Provision (benefit) for income taxes
  $ (42 )   $ 252     $ 7,314     $ (974 )
 
                       
Income (loss) from discontinued operations, net of taxes
  $ 2     $ 413     $ 11,913     $ (1,100 )
 
                       
(21) Gain on Disposition
     In September 2009, we disposed of our majority ownership interest in our Diamics Inc., or Diamics, operation, which was part of our professional diagnostics reporting unit and business segment. During the period from the date of acquisition of Diamics in July 2007 until its disposition in September 2009, under the principles of consolidation, we consolidated 100% of the operating results of the Diamics operations in our consolidated statement of operations. As a result of the disposition, we recorded a gain of $3.4 million during the three and nine months ended September 30, 2009.
(22) Guarantor Financial Information
     Our 9% senior subordinated notes due 2016, our 7.875% senior notes due 2016, and our 8.625% subordinated notes due 2018, are guaranteed by certain of our consolidated subsidiaries, or the Guarantor Subsidiaries. The guarantees are full and unconditional and joint and several. The following supplemental financial information sets forth, on a consolidating basis, balance sheets as of September 30, 2010 and December 31, 2009, the statements of operations for the three and nine months ended September 30, 2010 and 2009 and cash flows for the nine months ended September 30, 2010 and 2009 for Alere Inc., the Guarantor Subsidiaries and our other subsidiaries, or the Non-Guarantor Subsidiaries. The supplemental financial information reflects the investments of Alere Inc. and the Guarantor Subsidiaries in the Guarantor and Non-Guarantor Subsidiaries using the equity method of accounting.

30


Table of Contents

ALERE INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)

(unaudited)
     We have extensive transactions and relationships between various members of the 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 wholly unrelated parties.

31


Table of Contents

ALERE INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)

(unaudited)
CONSOLIDATING STATEMENT OF OPERATIONS
For the Three Months Ended September 30, 2010

(in thousands)
                                         
            Guarantor     Non-Guarantor              
    Issuer     Subsidiaries     Subsidiaries     Eliminations     Consolidated  
Net product sales
  $     $ 206,790     $ 183,080     $ (26,437 )   $ 363,433  
Services revenue
          156,956       14,167             171,123  
 
                             
Net product sales and services revenue
          363,746       197,247       (26,437 )     534,556  
License and royalty revenue
          2,626       2,951       (1,454 )     4,123  
 
                             
Net revenue
          366,372       200,198       (27,891 )     538,679  
 
                             
Cost of net product sales
    4,808       93,727       97,895       (25,881 )     170,549  
Cost of services revenue
    (974 )     77,262       4,494             80,782  
 
                             
Cost of net product sales and services revenue
    3,834       170,989       102,389       (25,881 )     251,331  
Cost of license and royalty revenue
          36       3,220       (1,454 )     1,802  
 
                             
Cost of net revenue
    3,834       171,025       105,609       (27,335 )     253,133  
 
                             
Gross profit
    (3,834 )     195,347       94,589       (556 )     285,546  
 
                             
Operating expenses:
                                       
Research and development
    7,216       15,223       9,995             32,434  
Sales and marketing
    (2,002 )     83,449       44,159             125,606  
General and administrative
    18,496       55,598       22,037             96,131  
 
                             
Operating income (loss)
    (27,544 )     41,077       18,398       (556 )     31,375  
Interest expense, including amortization of original issue discounts and deferred financing costs
    (33,782 )     (18,791 )     (1,899 )     20,292       (34,180 )
Other income (expense), net
    19,682       (79 )     8,214       (20,292 )     7,525  
 
                             
Income (loss) from continuing operations before provision (benefit) for income taxes
    (41,644 )     22,207       24,713       (556 )     4,720  
Provision (benefit) for income taxes
    (12,623 )     11,362       4,212       (3,118 )     (167 )
 
                             
Income (loss) from continuing operations before
equity earnings of unconsolidated entities, net of tax
    (29,021 )     10,845       20,501       2,562       4,887  
Equity in earnings of subsidiaries, net of tax
    33,356                   (33,356 )      
Equity earnings of unconsolidated entities, net of tax
    514             (428 )     (148 )     (62 )
 
                             
Income (loss) from continuing operations
    4,849       10,845       20,073       (30,942 )     4,825  
Income (loss) from discontinued operations, net of tax
    (22 )     (86 )     68       42       2  
 
                             
Net income (loss)
    4,827       10,759       20,141       (30,900 )     4,827  
Less: Net income (loss) attributable to non-controlling interests
                1,494             1,494  
 
                             
Net income (loss) attributable to Alere Inc. and Subsidiaries
    4,827       10,759       18,647       (30,900 )     3,333  
Preferred stock dividends
    (6,147 )                       (6,147 )
 
                             
Net income (loss) available to common stockholders
  $ (1,320 )   $ 10,759     $ 18,647     $ (30,900 )   $ (2,814 )
 
                             

32


Table of Contents

ALERE INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)

(unaudited)
CONSOLIDATING STATEMENT OF OPERATIONS
For the Three Months Ended September 30, 2009

(in thousands)
                                         
            Guarantor     Non-Guarantor              
    Issuer     Subsidiaries     Subsidiaries     Eliminations     Consolidated  
Net product sales
  $     $ 233,582     $ 163,276     $ (26,116 )   $ 370,742  
Services revenue
          132,293       1,782             134,075  
 
                             
Net product sales and services revenue
          365,875       165,058       (26,116 )     504,817  
License and royalty revenue
          2,942       7,006       (2,100 )     7,848  
 
                             
Net revenue
          368,817       172,064       (28,216 )     512,665  
 
                             
Cost of net product sales
    947       99,082       92,930       (23,746 )     169,213  
Cost of services revenue
    43       60,204       962             61,209  
 
                             
Cost of net product sales and services revenue
    990       159,286       93,892       (23,746 )     230,422  
Cost of license and royalty revenue
    (297 )     16       4,327       (2,100 )     1,946  
 
                             
Cost of net revenue
    693       159,302       98,219       (25,846 )     232,368  
 
                             
Gross profit
    (693 )     209,515       73,845       (2,370 )     280,297  
 
                             
Operating expenses:
                                       
Research and development
    7,890       14,471       5,359             27,720  
Sales and marketing
    2,149       80,606       33,525             116,280  
General and administrative
    17,486       50,884       18,077             86,447  
Gain on disposition
    (2,682 )           (673 )           (3,355 )
 
                             
Operating income (loss)
    (25,536 )     63,554       17,557       (2,370 )     53,205  
Interest expense, including amortization of original issue discounts and deferred financing costs
    (29,400 )     (9,760 )     (3,112 )     11,692       (30,580 )
Other income (expense), net
    10,884       (1,339 )     3,334       (11,692 )     1,187  
 
                             
Income (loss) from continuing operations before provision (benefit) for income taxes
    (44,052 )     52,455       17,779       (2,370 )     23,812  
Provision (benefit) for income taxes
    (2,619 )     24,725       5,988       (22,093 )     6,001  
 
                             
Income (loss) from continuing operations before
equity earnings of unconsolidated entities, net of tax
    (41,433 )     27,730       11,791       19,723       17,811  
Equity in earnings of subsidiaries, net of tax
    61,189                   (61,189 )      
Equity earnings of unconsolidated entities, net of tax
    527             1,598       (66 )     2,059  
 
                             
Income (loss) from continuing operations
    20,283       27,730       13,389       (41,532 )     19,870  
Income (loss) from discontinued operations, net of tax
          396       17             413  
 
                             
Net income (loss)
    20,283       28,126       13,406       (41,532 )     20,283  
Less: Net income (loss) attributable to non-controlling interests
                141             141  
 
                             
Net income (loss) attributable to Alere Inc. and Subsidiaries
    20,283       28,126       13,265       (41,532 )     20,142  
Preferred stock dividends
    (5,843 )                       (5,843 )
 
                             
Net income (loss) available to common stockholders
  $ 14,440     $ 28,126     $ 13,265     $ (41,532 )   $ 14,299  
 
                             

33


Table of Contents

ALERE INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)

(unaudited)
CONSOLIDATING STATEMENT OF OPERATIONS
For the Nine Months Ended September 30, 2010

(in thousands)
                                         
            Guarantor     Non-Guarantor              
    Issuer     Subsidiaries     Subsidiaries     Eliminations     Consolidated  
Net product sales
  $     $ 610,847     $ 533,980     $ (81,278 )   $ 1,063,549  
Services revenue
          457,695       39,597             497,292  
 
                             
Net product sales and services revenue
          1,068,542       573,577       (81,278 )     1,560,841  
License and royalty revenue
          6,950       13,048       (3,946 )     16,052  
 
                             
Net revenue
          1,075,492       586,625       (85,224 )     1,576,893  
 
                             
Cost of net product sales
    12,275       279,452       289,480       (80,217 )     500,990  
Cost of services revenue
    499       223,253       15,239             238,991  
 
                             
Cost of net product sales and services revenue
    12,774       502,705       304,719       (80,217 )     739,981  
Cost of license and royalty revenue
          46       9,311       (3,946 )     5,411  
 
                             
Cost of net revenue
    12,774       502,751       314,030       (84,163 )     745,392  
 
                             
Gross profit
    (12,774 )     572,741       272,595       (1,061 )     831,501  
 
                             
Operating expenses:
                                       
Research and development
    21,055       47,016       28,116             96,187  
Sales and marketing
    8,165       230,160       130,691             369,016  
General and administrative
    41,233       172,240       70,682             284,155  
 
                             
Operating income (loss)
    (83,227 )     123,325       43,106       (1,061 )     82,143  
Interest expense, including amortization of original issue discounts and deferred financing costs
    (98,707 )     (57,067 )     (6,900 )     61,753       (100,921 )
Other income (expense), net
    59,471       (754 )     17,717       (61,753 )     14,681  
 
                             
Income (loss) from continuing operations before provision (benefit) for income taxes
    (122,463 )     65,504       53,923       (1,061 )     (4,097 )
Provision (benefit) for income taxes
    (42,102 )     31,579       17,862       (8,303 )     (964 )
 
                             
Income (loss) from continuing operations before
equity earnings of unconsolidated entities, net of tax
    (80,361 )     33,925       36,061       7,242       (3,133 )
Equity in earnings of subsidiaries, net of tax
    94,042                   (94,042 )      
Equity earnings of unconsolidated entities, net of tax
    1,522             6,873       (200 )     8,195  
 
                             
Income (loss) from continuing operations
    15,203       33,925       42,934       (87,000 )     5,062  
Income (loss) from discontinued operations, net of tax
    1,772       15,940       1,514       (7,313 )     11,913  
 
                             
Net income (loss)
    16,975       49,865       44,448       (94,313 )     16,975  
Less: Net income (loss) attributable to non-controlling interests
                1,167             1,167  
 
                             
Net income (loss) attributable to Alere Inc. and Subsidiaries
    16,975       49,865       43,281       (94,313 )     15,808  
Preferred stock dividends
    (18,001 )                       (18,001 )
 
                             
Net income (loss) available to common stockholders
  $ (1,026 )   $ 49,865     $ 43,281     $ (94,313 )   $ (2,193 )
 
                             

34


Table of Contents

ALERE INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)

(unaudited)
CONSOLIDATING STATEMENT OF OPERATIONS
For the Nine Months Ended September 30, 2009

(in thousands)
                                         
            Guarantor     Non-Guarantor              
    Issuer     Subsidiaries     Subsidiaries     Eliminations     Consolidated  
Net product sales
  $     $ 640,771     $ 413,416     $ (81,584 )   $ 972,603  
Services revenue
          378,128       5,151             383,279  
 
                             
Net product sales and services revenue
          1,018,899       418,567       (81,584 )     1,355,882  
License and royalty revenue
          8,189       18,699       (6,300 )     20,588  
 
                             
Net revenue
          1,027,088       437,266       (87,884 )     1,376,470  
 
                             
Cost of net product sales
    2,460       329,656       234,171       (119,935 )     446,352  
Cost of services revenue
    136       169,728       2,259             172,123  
 
                             
Cost of net product sales and services revenue
    2,596       499,384       236,430       (119,935 )     618,475  
Cost of license and royalty revenue
    (297 )     (21 )     11,970       (6,300 )     5,352  
 
                             
Cost of net revenue
    2,299       499,363       248,400       (126,235 )     623,827  
 
                             
Gross profit
    (2,299 )     527,725       188,866       38,351       752,643  
 
                             
Operating expenses:
                                       
Research and development
    20,116       43,147       17,548             80,811  
Sales and marketing
    4,489       230,764       81,627             316,880  
General and administrative
    43,126       152,319       51,932             247,377  
Gain on disposition
    (2,682 )           (673 )           (3,355 )
 
                             
Operating income (loss)
    (67,348 )     101,495       38,432       38,351       110,930  
Interest expense, including amortization of original issue discounts and deferred financing costs
    (68,890 )     (29,830 )     (9,126 )     35,754       (72,092 )
Other income (expense), net
    33,310       (2,942 )     6,404       (35,754 )     1,018  
 
                             
Income (loss) from continuing operations before provision (benefit) for income taxes
    (102,928 )     68,723       35,710       38,351       39,856  
Provision (benefit) for income taxes
    (20,133 )     51,676       12,998       (31,640 )     12,901  
 
                             
Income (loss) from continuing operations before
equity earnings of unconsolidated entities, net of tax
    (82,795 )     17,047       22,712       69,991       26,955  
Equity in earnings of subsidiaries, net of tax
    112,580                   (112,580 )      
Equity earnings of unconsolidated entities, net of tax
    1,609             4,074       (144 )     5,539  
 
                             
Income (loss) from continuing operations
    31,394       17,047       26,786       (42,733 )     32,494  
Income (loss) from discontinued operations, net of tax
          (1,271 )     171             (1,100 )
 
                             
Net income (loss)
    31,394       15,776       26,957       (42,733 )     31,394  
Less: Net income (loss) attributable to non-controlling interests
                465             465  
 
                             
Net income (loss) attributable to Alere Inc. and Subsidiaries
    31,394       15,776       26,492       (42,733 )     30,929  
Preferred stock dividends
    (17,056 )                       (17,056 )
 
                             
Net income (loss) available to common stockholders
  $ 14,338     $ 15,776     $ 26,492     $ (42,733 )   $ 13,873  
 
                             

35


Table of Contents

ALERE INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)

(unaudited)
CONSOLIDATING BALANCE SHEET
September 30, 2010

(in thousands)
                                         
            Guarantor     Non-Guarantor              
    Issuer     Subsidiaries     Subsidiaries     Eliminations     Consolidated  
ASSETS
                                       
Current assets:
                                       
Cash and cash equivalents
  $ 240,269     $ 86,349     $ 160,963     $     $ 487,581  
Restricted cash
          1,872       827             2,699  
Marketable securities
          843       4,841             5,684  
Accounts receivable, net of allowances
          210,195       174,633             384,828  
Inventories, net
    249       129,028       140,365       (7,176 )     262,466  
Deferred tax assets
    36,907       27,947       1,811       (32,352 )     34,313  
Income tax receivable
          1,640       40             1,680  
Prepaid expenses and other current assets
    5,640       20,017       45,626               71,283  
Intercompany receivables
    932,475       429,117       12,933       (1,374,525 )      
 
                             
Total current assets
    1,215,540       907,008       542,039       (1,414,053 )     1,250,534  
Property, plant and equipment, net
    1,487       255,673       118,718       (6,083 )     369,795  
Goodwill
    2,307,755       649,570       775,338       (5,067 )     3,727,596  
Other intangible assets with indefinite lives
    6,916       16,920       42,767             66,603  
Finite-lived intangible assets, net
    111,157       1,114,450       482,653             1,708,260  
Deferred financing costs, net, and other non-current assets
    46,269       5,004       30,935             82,208  
Investments in unconsolidated entities
    1,942,252       2,619       37,457       (1,920,031 )     62,297  
Marketable securities
    14,364             6,648             21,012  
Deferred tax assets
    416             39,699       (17,697 )     22,418  
Intercompany notes receivable
    1,386,042       (18,328 )           (1,367,714 )      
 
                             
Total assets
  $ 7,032,198     $ 2,932,916     $ 2,076,254     $ (4,730,645 )   $ 7,310,723  
 
                             
 
                                       
LIABILITIES AND EQUITY
                                       
Current liabilities:
                                       
Current portion of long-term debt
  $ 9,750     $ 893     $ 4,387     $     $ 15,030  
Current portion of capital lease obligations
          1,545       288             1,833  
Accounts payable
    5,010       61,749       48,670             115,429  
Accrued expenses and other current liabilities
    (136,347 )     335,613       100,765       3,123       303,154  
Payable to joint venture, net
          475       4,298             4,773  
Deferred gain on joint venture
    16,332             272,233             288,565  
Intercompany payables
    409,471       280,819       684,235       (1,374,525 )      
 
                             
Total current liabilities
    304,216       681,094       1,114,876       (1,371,402 )     728,784  
 
                             
Long-term liabilities:
                                       
Long-term debt, net of current portion
    2,377,422             3,731             2,381,153  
Capital lease obligations, net of current portion
          844       95             939  
Deferred tax liabilities
    (48,848 )     417,545       112,857       (54,069 )     427,485  
Other long-term liabilities
    85,888       18,555       21,530             125,973  
Intercompany notes payables
    720,703       527,453       117,977       (1,366,133 )      
 
                             
Total long-term liabilities
    3,135,165       964,397       256,190       (1,420,202 )     2,935,550  
 
                             
Redeemable non-controlling interest
                50,371             50,371  
 
                             
Stockholders’ equity
    3,592,817       1,287,425       651,616       (1,939,041 )     3,592,817  
Non-controlling interests
                3,201             3,201  
 
                             
Equity
    3,592,817       1,287,425       654,817       (1,939,041 )     3,596,018  
 
                             
Total liabilities and equity
  $ 7,032,198     $ 2,932,916     $ 2,076,254     $ (4,730,645 )   $ 7,310,723  
 
                             

36


Table of Contents

ALERE INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)

(unaudited)
CONSOLIDATING BALANCE SHEET
December 31, 2009

(in thousands)
                                         
            Guarantor     Non-Guarantor              
    Issuer     Subsidiaries     Subsidiaries     Eliminations     Consolidated  
ASSETS
                                       
Current assets:
                                       
Cash and cash equivalents
  $ 294,137     $ 82,602     $ 116,034     $     $ 492,773  
Restricted cash
          1,576       848             2,424  
Marketable securities
          947                   947  
Accounts receivable, net of allowances
          188,355       166,098             354,453  
Inventories, net
          122,062       106,544       (7,067 )     221,539  
Deferred tax assets
    36,907       27,947       1,638             66,492  
Income tax receivable
          1,107                   1,107  
Prepaid expenses and other current assets
    8,160       25,077       39,838             73,075  
Assets held for sale
          53,545       603             54,148  
Intercompany receivables
    861,596       329,771       12,500       (1,203,867 )      
 
                             
Total current assets
    1,200,800       832,989       444,103       (1,210,934 )     1,266,958  
Property, plant and equipment, net
    1,646       241,732       86,034       (5,024 )     324,388  
Goodwill
    2,187,411       595,612       685,674       (5,339 )     3,463,358  
Other intangible assets with indefinite lives
    700       21,120       21,824             43,644  
Finite-lived intangible assets, net
    102,851       1,185,151       398,425             1,686,427  
Deferred financing costs, net, and other non-current assets
    43,368       5,640       23,754             72,762  
Investments in unconsolidated entities
    1,560,458       367       38,443       (1,535,303 )     63,965  
Marketable securities
    1,503                         1,503  
Deferred tax assets
                20,987             20,987  
Intercompany notes receivable
    1,296,373       83,510             (1,379,883 )      
 
                             
Total assets
  $ 6,395,110     $ 2,966,121     $ 1,719,244     $ (4,136,483 )   $ 6,943,992  
 
                             
 
                                       
LIABILITIES AND EQUITY
                                       
Current liabilities:
                                       
Current portion of long-term debt
  $ 9,750     $ 2,392     $ 6,828     $     $ 18,970  
Current portion of capital lease obligations
          499       400             899  
Accounts payable
    2,580       63,204       60,538             126,322  
Accrued expenses and other current liabilities
    (128,488 )     278,203       130,017             279,732  
Payable to joint venture, net
          (1,242 )     1,775             533  
Liabilities related to assets held for sale
          11,556       2             11,558  
Intercompany payables
    306,869       275,316       621,683       (1,203,868 )      
 
                             
Total current liabilities
    190,711       629,928       821,243       (1,203,868 )     438,014  
 
                             
Long-term liabilities:
                                       
Long-term debt, net of current portion
    2,125,006             3,509             2,128,515  
Capital lease obligations, net of current portion
          698       242             940  
Deferred tax liabilities
    (35,999 )     423,303       54,745             442,049  
Deferred gain on joint venture
    16,309             272,458             288,767  
Other long-term liabilities
    68,464       16,603       31,751             116,818  
Intercompany notes payables
    503,064       746,456       127,822       (1,377,342 )      
 
                             
Total long-term liabilities
    2,676,844       1,187,060       490,527       (1,377,342 )     2,977,089  
 
                             
Stockholders’ equity
    3,527,555       1,149,133       406,140       (1,555,273 )     3,527,555  
Non-controlling interests
                1,334             1,334  
 
                             
Equity
    3,527,555       1,149,133       407,474       (1,555,273 )     3,528,889  
 
                             
Total liabilities and equity
  $ 6,395,110     $ 2,966,121     $ 1,719,244     $ (4,136,483 )   $ 6,943,992  
 
                             

37


Table of Contents

ALERE INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)

(unaudited)
CONSOLIDATING STATEMENT OF CASH FLOWS
For the Nine Months Ended September 30, 2010

(in thousands)
                                         
            Guarantor     Non-Guarantor              
    Issuer     Subsidiaries     Subsidiaries     Eliminations     Consolidated  
Cash Flows from Operating Activities:
                                       
Net income (loss)
  $ 16,975     $ 49,865     $ 44,448     $ (94,313 )   $ 16,975  
Income (loss) from discontinued operations, net of tax
    1,772       15,940       1,514       (7,313 )     11,913  
 
                             
Income (loss) from continuing operations
    15,203       33,925       42,934       (87,000 )     5,062  
Adjustments to reconcile income (loss) from continuing operations to net cash (used in) provided by operating activities:
                                       
Equity in earnings of subsidiaries, net of tax
    (94,042 )                 94,042        
Non-cash interest expense related to amortization of original issue discounts and write-off of deferred financing costs
    9,025       211       1,048             10,284  
Depreciation and amortization
    16,724       183,016       78,265       (2,498 )     275,507  
Non-cash stock-based compensation expense
    22,947                         22,947  
Impairment of inventory
          136       576             712  
Impairment of long-lived assets
          651       (33 )           618  
(Gain) Loss on sale of fixed assets
          357       250             607  
Equity earnings of unconsolidated entities, net of tax
    (1,522 )           (6,873 )     200       (8,195 )
Deferred income taxes
          (24,393 )     8,890       (17,753 )     (33,256 )
Other non-cash items
    (2,348 )     976       (6 )           (1,378 )
Changes in assets and liabilities, net of acquisitions:
                                       
Accounts receivable, net
          (4,492 )     14,219       (12,280 )     (2,553 )
Inventories, net
          (5,231 )     (23,786 )     (90 )     (29,107 )
Prepaid expenses and other current assets
    2,551       (1,643 )     (6,436 )     12,280       6,752  
Accounts payable
    2,430       (880 )     (20,973 )           (19,423 )
Accrued expenses and other current liabilities
    (34,582 )     58,701       (10,540 )     9,542       23,121  
Other non-current liabilities
    (11,579 )     279       (10,684 )           (21,984 )
Intercompany (receivable) payable
    (33,474 )     (216,430 )     249,904                
 
                             
Net cash (used in) provided by continuing operations
    (108,667 )     25,183       316,755       (3,557 )     229,714  
Net cash used in discontinued operations
          (390 )                 (390 )
 
                             
Net cash (used in) provided by operating activities
    (108,667 )     24,793       316,755       (3,557 )     229,324  
 
                             
Cash Flows from Investing Activities:
                                       
Purchases of property, plant and equipment
    (71 )     (46,129 )     (25,814 )     3,557       (68,457 )
Proceeds from sale of property, plant and equipment
          203       439             642  
Cash paid for acquisitions and transaction costs, net of cash acquired
    (192,975 )     (33,409 )     (239,199 )           (465,583 )
Increase in marketable securities
    (12,619 )           (5,268 )           (17,887 )
Net cash received from equity method investments
    336       44       10,455             10,835  
Increase in other assets
          (406 )     (1,311 )           (1,717 )
 
                             
Net cash (used in) provided by continuing operations
    (205,329 )     (79,697 )     (260,698 )     3,557       (542,167 )
Net cash provided by discontinued operations
          61,446       2,000             63,446  
 
                             
Net cash (used in) provided by investing activities
    (205,329 )     (18,251 )     (258,698 )     3,557       (478,721 )
 
                             
Cash Flows from Financing Activities:
                                       
(Increase) decrease in restricted cash
          (296 )     16             (280 )
Cash paid for financing costs
    (9,590 )                       (9,590 )
Proceeds from issuance of common stock, net of issuance costs
    17,839                         17,839  
Proceeds on long-term debt
    400,000                         400,000  
Repayment on long-term debt
    (7,313 )                       (7,313 )
Net repayments from revolving lines-of-credit
    (142,000 )     (1,445 )     (3,540 )           (146,985 )
Excess tax benefit on exercised stock options
    1,300                         1,300  
Principal payments of capital lease obligations
          (1,054 )     (216 )           (1,270 )
Other
    (108 )           (401 )           (509 )
 
                             
Net cash provided by (used in) continuing operations
    260,128       (2,795 )     (4,141 )           253,192  
Net cash provided by discontinued operations
                             
 
                             
Net cash provided by (used in) financing activities
    260,128       (2,795 )     (4,141 )           253,192  
 
                             
Foreign exchange effect on cash and cash equivalents
                (8,987 )           (8,987 )
 
                             
Net (decrease) increase in cash and cash equivalents
    (53,868 )     3,747       44,929             (5,192 )
Cash and cash equivalents, beginning of period
    294,137       82,602       116,034             492,773  
 
                             
Cash and cash equivalents, end of period
  $ 240,269     $ 86,349     $ 160,963     $     $ 487,581  
 
                             

38


Table of Contents

ALERE INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)

(unaudited)
CONSOLIDATING STATEMENT OF CASH FLOWS
For the Nine Months Ended September 30, 2009

(in thousands)
                                         
            Guarantor     Non-Guarantor              
    Issuer     Subsidiaries     Subsidiaries     Eliminations     Consolidated  
Cash Flows from Operating Activities:
                                       
Net income (loss)
  $ 31,394     $ 15,776     $ 26,957     $ (42,733 )   $ 31,394  
Income (loss) from discontinued operations, net of tax
          (1,271 )     171             (1,100 )
 
                             
Income (loss) from continuing operations
    31,394       17,047       26,786       (42,733 )     32,494  
Adjustments to reconcile income (loss) from continuing operations to net cash provided by (used in) operating activities:
                                       
Equity in earnings of subsidiaries, net of tax
    (112,580 )                 112,580        
Non-cash interest expense related to amortization of original issue discounts and write-off of deferred financing costs
    6,018             443             6,461  
Depreciation and amortization
    3,937       182,436       38,159       (124 )     224,408  
Non-cash stock-based compensation expense
    20,287                         20,287  
Impairment of inventory
          838                   838  
Impairment of long-lived assets
          1,272       1,909             3,181  
(Gain) loss on sale of fixed assets
    4       562       45             611  
Equity earnings of unconsolidated entities, net of tax
    (1,609 )           (4,074 )     144       (5,539 )
Deferred income taxes
    1       (16,488 )     (660 )     6,526       (10,621 )
Other non-cash items
    292       1,450       (673 )           1,069  
Changes in assets and liabilities, net of acquisitions:
                                       
Accounts receivable, net
          (19,225 )     (28,042 )     35       (47,232 )
Inventories, net
          41,773       (9,051 )     (40,379 )     (7,657 )
Prepaid expenses and other current assets
    1,408       4,336       (2,288 )           3,456  
Accounts payable
    2,407       4,516       12,608             19,531  
Accrued expenses and other current liabilities
    (15,010 )     56,167       (44,753 )     (7,074 )     (10,670 )
Other non-current liabilities
    1,032       5,774       3,500             10,306  
Intercompany (receivable) payable
    (43,709 )     (213,151 )     288,308       (31,448 )      
 
                             
Net cash provided by (used in) continuing operations
    (106,128 )     67,307       282,217       (2,473 )     240,923  
Net cash provided by (used in) discontinued operations
          4,482       (106 )           4,376  
 
                             
Net cash provided by (used in) operating activities
    (106,128 )     71,789       282,111       (2,473 )     245,299  
 
                             
Cash Flows from Investing Activities:
                                       
Purchases of property, plant and equipment
    (184 )     (54,914 )     (22,074 )     2,713       (74,459 )
Proceeds from sale of property, plant and equipment
          232       440             672  
Cash received (paid) for acquisitions and transaction costs, net of cash acquired
    (158,527 )     14,396       (253,416 )     80       (397,467 )
Net cash received from equity method investments
    979             11,020       4       12,003  
(Increase) decrease in other assets
          (1,140 )     (3,592 )     (324 )     (5,056 )
 
                             
Net cash provided by (used in) continuing operations
    (157,732 )     (41,426 )     (267,622 )     2,473       (464,307 )
Net cash provided by (used in) discontinued operations
          (271 )                 (271 )
 
                             
Net cash provided by (used in) investing activities
    (157,732 )     (41,697 )     (267,622 )     2,473       (464,578 )
 
                             
Cash Flows from Financing Activities:
                                       
(Increase) decrease in restricted cash
          (267 )     15             (252 )
Cash paid for financing costs
    (15,331 )                       (15,331 )
Proceeds from issuance of common stock, net of issuance costs
    15,539                         15,539  
Proceeds on long-term debt
    631,176                         631,176  
Repayment on long-term debt
    (7,312 )     (1,032 )                 (8,344 )
Net proceeds (repayments) from revolving lines-of-credit
          (1,283 )     (2,170 )           (3,453 )
Excess tax benefit on exercised stock options
    2,152                         2,152  
Principal payments of capital lease obligations
          (469 )     (171 )           (640 )
Other
    (115 )                       (115 )
 
                             
Net cash provided by (used in) continuing operations
    626,109       (3,051 )     (2,326 )           620,732  
Net cash provided by (used in) discontinued operations
          (8 )                 (8 )
 
                             
Net cash provided by (used in) financing activities
    626,109       (3,059 )     (2,326 )           620,724  
 
                             
Foreign exchange effect on cash and cash equivalents
                13,102             13,102  
 
                             
Net increase (decrease) in cash and cash equivalents
    362,249       27,033       25,265             414,547  
Cash and cash equivalents, beginning of period
    1,743       69,794       69,787             141,324  
 
                             
Cash and cash equivalents, end of period
  $ 363,992     $ 96,827     $ 95,052     $     $ 555,871  
 
                             

39


Table of Contents

ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
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. Forward-looking statements in this item include, without limitation, statements regarding anticipated expansion and growth in certain of our product and service offerings; the development and introduction of new technologies and products; the potential impact of these technologies and products under development; our expectations with respect to Apollo, our new integrated health management technology platform; our ability to accelerate adoption of our health management services; and our funding plans for our future working capital needs and commitments. Actual results or developments could differ materially from those projected in such statements as a result of numerous factors, including, without limitation, those risks and uncertainties set forth in Part I, Item 1A, “Risk Factors,” of our Annual Report on Form 10-K, as amended, for the year ended December 31, 2009 and other risk factors identified herein or from time to time in our periodic filings with the SEC. We do not undertake any obligation to update any forward-looking statements. This report and, in particular, the following discussion and analysis of our financial condition and results of operations, should be read in light of those risks and uncertainties and in conjunction with our accompanying consolidated financial statements and notes thereto.
Financial Overview
     We enable individuals to take charge of improving their health and quality of life at home by developing new capabilities in near-patient diagnosis, monitoring and health management. Our global, leading products and services, as well as our new product development efforts, currently focus on cardiology, women’s health, infectious disease, oncology and drugs of abuse. We are continuing to expand our product and service offerings in all of these categories both through acquisitions and new product development.
     Through our February 2010 acquisition of Kroll Laboratory Specialists, Inc., which we have since renamed Alere Toxicology Services, or ATS, we continued to expand the range of drugs of abuse testing products and services that we can offer the government, employers, health plans and healthcare professionals. ATS’ laboratories, which are certified by the U.S. Substance Abuse and Mental Health Services Administration, or SAMHSA, allow us to reach the growing U.S. regulated drugs of abuse testing market. Our acquisition of a majority interest in Standard Diagnostics, Inc., or Standard Diagnostics, during the first quarter of 2010 brought us a comprehensive range of rapid diagnostic products, with particular strength in the infectious disease category.
     Our research and development efforts continue to focus on developing diagnostic technology platforms, including our Alere Heart Check handheld CHF monitoring system and our molecular platform under development in Germany, which will facilitate movement of testing from the hospital and central laboratory to the physician’s office and, ultimately, the home. Additionally, through our strong pipeline of novel proteins or combinations of proteins that function as disease biomarkers, we are developing new point-of-care tests targeted toward all of our areas of focus.
     As a global, leading supplier of near-patient monitoring tools, as well as value-added healthcare services, we are well positioned to improve care and lower healthcare costs for both providers and patients. Our rapidly growing home coagulation monitoring business, which supports doctors’ and patients’ efforts to monitor warfarin therapy using our Alere INRatio blood coagulation monitoring system, represents an early example of the convergence of diagnostic devices with health management services. Our innovative, integrated health management software system, called Apollo, which we continue to make available to customers, is also aimed at improving the integration and quality of distributed care services. Using a sophisticated data engine for acquiring and analyzing information, combined with a state-of-the-art solution for communicating with individuals and their health partners, we expect Apollo to benefit healthcare providers, health insurers and patients alike by enabling more efficient and effective health management programs.

40


Table of Contents

     Net revenue increased by $26.0 million, or 5%, to $538.7 million for the three months ended September 30, 2010, from $512.7 million for the three months ended September 30, 2009. Net revenue increased primarily as a result of our health management and professional diagnostics-related acquisitions which contributed $92.1 million toward the increase. Offsetting the increased net revenue contributed by acquisitions was a decrease in North American flu-related net product sales during the three months ended September 30, 2010, as compared to the three months ended September 30, 2009. Net product sales from our North American flu sales declined approximately $33.4 million, comparing the three months ended September 30, 2010 to the three months ended September 30, 2009, as a result of unusually strong flu sales during the three months ended September 30, 2009 caused by the H1N1 flu outbreak. In addition, worldwide respiratory sales, excluding North American flu sales discussed above, declined approximately $11.6 million, comparing the three months ended September 30, 2010 to the three months ended September 30, 2009. Net revenue in our health management segment, excluding net revenue contributed by our health management acquisitions discussed above, was adversely impacted as a result of the increasingly competitive environment, particularly in the less differentiated services.
     Net revenue increased by $200.4 million, or 15%, to $1.6 billion for the nine months ended September 30, 2010, from $1.4 billion for the nine months ended September 30, 2009. Net revenue increased primarily as a result of our health management and professional diagnostics-related acquisitions, which contributed $289.4 million toward the increase. Offsetting the increased net revenue contributed by acquisitions was a decrease in North American flu-related net product sales during the nine months ended September 30, 2010, as compared to the nine months ended September 30, 2009. Net product sales from our North American flu sales declined approximately $51.5 million, comparing the nine months ended September 30, 2010 to the nine months ended September 30, 2009, as a result of a weaker than normal flu season and unusually strong flu sales during the nine months ended September 30, 2009 caused by the H1N1 flu outbreak. In addition, worldwide respiratory sales, excluding North American flu sales discussed above, declined approximately $17.1 million, comparing the nine months ended September 30, 2010 to the nine months ended September 30, 2009. Net revenue in our health management segment, excluding net revenue contributed by our health management acquisitions discussed above, was adversely impacted as a result of the increasingly competitive environment, particularly in the less differentiated services.
     For the three and nine months ended September 30, 2010, we generated a net loss available to common stockholders of $2.8 million and $2.2 million, respectively, compared to net income available to common stockholders of $14.3 million and $13.9 million for the three and nine months ended September 30, 2009, respectively.
Results of Operations
     The following discussions of our results of continuing operations exclude the results related to the vitamins and nutritional supplements business segment, which was previously presented as a separate operating segment prior to its divestiture in January 2010. The vitamins and nutritionals supplements business segment has been segregated from continuing operations and reflected as discontinued operations for all periods presented. See “Discontinued Operations” below. Results excluding the impact of currency translation are calculated on the basis of local currency results, using foreign currency exchange rates applicable to the earlier comparative period. We believe presenting information using the same foreign currency exchange rates helps investors isolate the impact of changes in those rates from other trends. Our results of operations were as follows:
     Net Product Sales and Services Revenue, Total and by Business Segment. Total net product sales and services revenue increased by $29.7 million, or 6%, to $534.6 million for the three months ended September 30, 2010, from $504.8 million for the three months ended September 30, 2009. Excluding the impact of currency translation, net product sales and services revenue for the three months ended September 30, 2010 increased by $33.6 million, or 7%, compared to the three months ended September 30, 2009. Total net product sales and services revenue increased by $205.0 million, or 15%, to $1.6 billion for the nine months ended September 30, 2010, from $1.4 billion for the nine months ended September 30, 2009. Excluding the impact of currency translation, net product sales and services revenue for the nine months ended September 30, 2010 increased by $199.7 million, or 15%, compared to the nine months ended September 30, 2009. Net product sales and services revenue by business segment for the three and nine months ended September 30, 2010 and 2009 are as follows (in thousands):

41


Table of Contents

                                                 
    Three Months Ended             Nine Months Ended        
    September 30,     %     September 30,     %  
    2010     2009     Change     2010     2009     Change  
Professional diagnostics
  $ 359,481     $ 334,345       8 %   $ 1,039,315     $ 876,258       19 %
Health management
    152,894       131,335       16 %     451,182       376,013       20 %
Consumer diagnostics
    22,181       39,137       (43 )%     70,344       103,611       (32 )%
 
                                       
Total net product sales and services revenue
  $ 534,556     $ 504,817       6 %   $ 1,560,841     $ 1,355,882       15 %
 
                                       
Professional Diagnostics
     Net product sales and services revenue from our professional diagnostics business segment increased by $25.1 million, or 8%, comparing the three months ended September 30, 2010 to the three months ended September 30, 2009. Net product sales and services revenue increased primarily as a result of our acquisitions of: (i) Concateno plc, or Concateno, in August 2009, which contributed $8.8 million of net product sales and services revenue in excess of those earned in the prior year’s comparative period, (ii) Standard Diagnostics, in the first quarter of 2010, which contributed $24.9 million of net product sales and services revenue, (iii) the ATS business, in February 2010, which contributed $9.5 million of net product sales and services revenue and (v) various less significant acquisitions, which contributed an aggregate of $12.8 million of such increase. Offsetting the increased net product sales and services revenue contributed by acquisitions was a decrease in North American flu-related net product sales during the three months ended September 30, 2010, as compared to the three months ended September 30, 2009. Net product sales from our North American flu sales declined approximately $33.4 million, comparing the three months ended September 30, 2010 to the three months ended September 30, 2009, as a result of unusually strong flu sales during the three months ended September 30, 2009 caused by the H1N1 flu outbreak. In addition, worldwide respiratory sales, excluding North American flu sales discussed above, declined approximately $11.6 million, comparing the three months ended September 30, 2010 to the three months ended September 30, 2009. Excluding the impact of currency translation, net product sales and services revenue from our professional diagnostics business segment increased by $28.6 million, or 9%, comparing the three months ended September 30, 2010 to the three months ended September 30, 2009.
     Net product sales and services revenue from our professional diagnostics business segment increased by $163.1 million, or 19%, comparing the nine months ended September 30, 2010 to the nine months ended September 30, 2009. Net product sales and services revenue increased primarily as a result of our acquisitions of: (i) the ACON Second Territory Business, in April 2009, which contributed $15.1 million of net product sales and services revenue in excess of those earned in the prior year’s comparative period, (ii) Concateno, in August 2009, which contributed $48.9 million of net product sales and services revenue in excess of those earned in the prior year’s comparative period, (iii) Standard Diagnostics, in the first quarter of 2010, which contributed $56.8 million of net product sales and services revenue, (iv) the ATS business, in February 2010, which contributed $23.8 million of net product sales and services revenue and (v) various less significant acquisitions, which contributed an aggregate of $27.5 million of such increase. Offsetting the increased net product sales and services revenue contributed by acquisitions was a decrease in North American flu-related net product sales during the nine months ended September 30, 2010, as compared to the nine months ended September 30, 2009. Net product sales from our North American flu sales declined approximately $51.5 million, comparing the nine months ended September 30, 2010 to the nine months ended September 30, 2009, as a result of a weaker than normal flu season in 2010 and unusually strong flu sales during the nine months ended September 30, 2009 caused by the H1N1 flu outbreak. In addition, worldwide respiratory sales, excluding North American flu sales discussed above, declined approximately $17.1 million, comparing the nine months ended September 30, 2010 to the nine months ended September 30, 2009. Excluding the impact of currency translation, net product sales and services revenue from our professional diagnostics business segment increased by $157.7 million, or 18%, comparing the nine months ended September 30, 2010 to the nine months ended September 30, 2009.

42


Table of Contents

Health Management
     Our health management net product sales and services revenue increased by $21.6 million, or 16%, comparing the three months ended September 30, 2010 to the three months ended September 30, 2009. Of the increase, net product sales and services revenue increased primarily as a result of our acquisitions of: (i) Free & Clear, Inc., or Free & Clear, in September 2009, which contributed $18.1 million of net products sales and services revenue in excess of those earned in the prior year’s comparative period, (ii) Tapestry Medical, Inc., or Tapestry, in November 2009, which contributed $14.9 million of net product sales and services revenue (which includes revenue transferred to Tapestry from our Quality Assured Services, Inc., or QAS, subsidiary), (iii) CVS Caremark’s Accordant Common disease management program, or Accordant, in September 2009, which contributed $2.2 million of net product sales and services revenue in excess of those earned in the prior year’s comparative period and (iv) various less significant acquisitions, which contributed an aggregate of $1.0 million of such increase. Net product sales and services revenue in our health management segment, excluding the impact of these acquisitions, was adversely impacted by the increasingly competitive environment, particularly in the less differentiated services.
     Our health management net product sales and services revenue increased by $75.2 million, or 20%, comparing the nine months ended September 30, 2010 to the nine months ended September 30, 2009. Of the increase, net product sales and services revenue increased primarily as a result of our acquisitions of: (i) Free & Clear, in September 2009, which contributed $55.1 million of net products sales and services revenue in excess of those earned in the prior year’s comparative period, (ii) Tapestry, in November 2009, which contributed $41.1 million of net product sales and services revenue (which includes revenue transferred to Tapestry from our QAS subsidiary), (iii) Accordant, in September 2009, which contributed $15.3 million of net product sales and services revenue in excess of those earned in the prior year’s comparative period and (iv) various less significant acquisitions, which contributed an aggregate of $4.8 million of such increase. Net product sales and services revenue in our health management segment, excluding the impact of these acquisitions, was adversely impacted by the increasingly competitive environment, particularly in the less differentiated services.
Consumer Diagnostics
     Net product sales and services revenue from our consumer diagnostics business segment decreased by $17.0 million, or 43%, comparing the three months ended September 30, 2010 to the three months ended September 30, 2009. Net product sales and services revenue from our consumer diagnostics business segment decreased by $33.3 million, or 32%, comparing the nine months ended September 30, 2010 to the nine months ended September 30, 2009. The decrease during the three and nine months ended September 30, 2010, as compared to the three and nine months ended September 30, 2009, was primarily driven by a decrease of approximately $16.4 million and $31.0 million, respectively, of manufacturing revenue associated with our manufacturing agreement with our 50/50 joint venture with P&G, or SPD, whereby we manufacture and sell consumer diagnostic products to SPD. Our manufacturing revenue is generated on a cost-plus basis. Manufacturing revenue has been adversely impacted as a result of transitioning the manufacturing of our consumer diagnostic-related products to some of our lower cost facilities. Net product sales by SPD were $50.1 million and $154.4 million during the three and nine months ended September 30, 2010, respectively, as compared to $53.0 million and $155.0 million during the three and nine months ended September 30, 2009, respectively.
     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 approximately $3.7 million, or 47%, to $4.1 million for the three months ended September 30, 2010, from $7.8 million for the three months ended September 30, 2009. The decrease in license and royalty revenue during the three months ended September 30, 2010, as compared to the three months ended September 30, 2009, was almost entirely attributed to a decrease in royalty payments received from Quidel Corporation, or Quidel, under existing licensing agreements. The decrease in royalties received from Quidel during the three months ended September 30, 2010, as compared to the three months ended September 30, 2009, is a result of the decrease in flu-related products sales. License and royalty revenue decreased by approximately $4.5 million, or 22%, to $16.1 million for the nine months ended September 30, 2010, from $20.6 million for the nine months ended September 30, 2009. The decrease in license and royalty revenue during the nine months ended September 30, 2010, as compared to the nine months ended September 30, 2009, was largely attributed to a $5.0 million royalty received in connection with a license arrangement in the field of animal health diagnostics during the nine months ended September 30, 2009.

43


Table of Contents

     Gross Profit and Margin. Gross profit increased by $5.2 million, or 2%, to $285.5 million for the three months ended September 30, 2010, from $280.3 million for the three months ended September 30, 2009. Gross profit increased by $78.9 million, or 10%, to $831.5 million for the nine months ended September 30, 2010, from $752.6 million for the nine months ended September 30, 2009.
     The increase in gross profit during the three and nine months ended September 30, 2010 compared to the three and nine months ended September 30, 2009 was largely attributed to the increase in net product sales and services revenue resulting from acquisitions and organic growth from our professional diagnostics business segment. Cost of net revenue during the three and nine months ended September 30, 2010 included amortization of $1.3 million and $7.0 million, respectively, relating to the write-up of inventory to fair value in connection with the acquisitions of Standard Diagnostics during the first quarter of 2010, Scipac Holdings Limited, or Scipac, during the second quarter of 2010 and Diagnostixx of California, Corp. (d/b/a Immunalysis Corporation), or Immunalysis, during the third quarter of 2010. Cost of net revenue during both the three and nine months ended September 30, 2009 included amortization of $0.7 million relating to the write-up of inventory to fair value in connection with the acquisition of Concateno during the third quarter of 2009.
     Cost of net revenue included amortization expense of $16.1 million and $10.3 million for the three months ended September 30, 2010 and 2009, respectively, and $46.7 million and $30.5 million for the nine months ended September 30, 2010 and 2009, respectively.
     Overall gross margin was 53% for both the three and nine months ended September 30, 2010, compared to 55% for both the three and nine months ended September 30, 2009.
     Gross Profit from Net Product Sales and Services Revenue, Total and by Business Segment. Gross profit from total net product sales and services revenue increased by $8.8 million, or 3%, to $283.2 million for the three months ended September 30, 2010, from $274.4 million for the three months ended September 30, 2009. Gross profit from total net product sales and services revenue increased by $83.5 million, or 11%, to $820.9 million for the nine months ended September 30, 2010, from $737.4 million for the nine months ended September 30, 2009. Gross profit from net product sales and services revenue by business segment for the three and nine months ended September 30, 2010 and 2009 are as follows (in thousands):
                                                 
    Three Months Ended             Nine Months Ended        
    September 30,     %     September 30,     %  
    2010     2009     Change     2010     2009     Change  
Professional diagnostics
  $ 199,683     $ 198,486       1 %   $ 575,240     $ 517,450       11 %
Health management
    77,732       69,762       11 %     228,655       204,251       12 %
Consumer diagnostics
    5,810       6,147       (5 )%     16,965       15,706       8 %
 
                                       
Total gross profit from net product sales and services revenue
  $ 283,225     $ 274,395       3 %   $ 820,860     $ 737,407       11 %
 
                                       
Professional Diagnostics
     Gross profit from net product sales and services revenue from our professional diagnostics business segment increased by $1.2 million, or 1%, to $199.7 million during the three months ended September 30, 2010, compared to $198.5 million for the three months ended September 30, 2009, principally as a result of gross profit earned on revenue from acquired businesses, as discussed above. Reducing gross profit for the three months ended September 30, 2010 was amortization of $1.3 million relating to the write-up of inventory to fair value in connection with the acquisitions of Scipac during the second quarter of 2010 and Immunalysis during the third quarter of 2010. Reducing gross profit for the three months ended September 30, 2009 was amortization of $0.7 million relating to the write-up of inventory to fair value in connection with the acquisition of Concateno during the third quarter of 2009. Start up costs associated with our production of CD4 disposable tests also contributed to reduced gross profit.
     Gross profit from net product sales and services revenue from our professional diagnostics business segment increased by $57.8 million, or 11%, to $575.2 million during the nine months ended September 30, 2010, compared to $517.5 million for the nine months ended September 30, 2009, principally as a result of gross profit earned on revenue from acquired businesses, as discussed above. Reducing gross profit for the nine months ended September 30, 2010 was amortization of $7.0 million relating to the write-up of inventory to fair value in connection with the acquisitions of Standard Diagnostics in the first quarter of 2010, Scipac during the second quarter of 2010 and Immunalysis during the third quarter of 2010. Reducing gross profit for the nine months ended September 30, 2009

44


Table of Contents

was amortization of $0.7 million relating to the write-up of inventory to fair value in connection with the acquisition of Concateno during the third quarter of 2009. Start up costs associated with our production of CD4 disposable tests also contributed to reduced gross profit.
     As a percentage of our professional diagnostics net product sales and services revenue, gross margin for the three and nine months ended September 30, 2010 was 56% and 55%, respectively, compared to 59% for both the three and nine months ended September 30, 2009. The inventory write-ups noted above, coupled with higher revenue from our recently acquired drugs of abuse businesses, which contribute lower than segment average gross margins, and a decrease in North American flu-related net product sales, which contribute higher than segment average gross margin, contributed to the decrease in gross margin percentage for the three and nine months ended September 30, 2010, compared to the three and nine months ended September 30, 2009.
Health Management
     Gross profit from net product sales and services revenue from our health management business segment increased by $8.0 million, or 11%, to $77.7 million during the three months ended September 30, 2010, compared to $69.8 million during the three months ended September 30, 2009. Gross profit from net product sales and services revenue from our health management business segment increased by $24.4 million, or 12%, to $228.7 million during the nine months ended September 30, 2010 compared to $204.3 million during the nine months ended September 30, 2009. The increase in gross profit for the three and nine months ended September 30, 2010 compared to the three and nine months ended September 30, 2009, was largely attributed to gross margins earned on revenue from recent acquisitions, as discussed above.
     As a percentage of our health management net product sales and services revenue, gross margin for both the three and nine months ended September 30, 2010 was 51%, compared to 53% and 54% for the three and nine months ended September 30, 2009, respectively. The lower margin percentage earned during both the three and nine months ended September 30, 2010, as compared to the three and nine months ended September 30, 2009, is a result of the increasingly competitive environment for the health management segment, particularly in the less differentiated services.
Consumer Diagnostics
     Gross profit from net product sales and services revenue from our consumer diagnostics business segment decreased by $0.3 million, or 5%, to $5.8 million for the three months ended September 30, 2010, compared to $6.1 million for the three months ended September 30, 2009. Gross profit from net product sales and services revenue from our consumer diagnostics business segment increased by $1.3 million, or 8%, to $17.0 million for the nine months ended September 30, 2010, compared to $15.7 million for the nine months ended September 30, 2009.
     As a percentage of our consumer diagnostics net product sales and services revenue, gross margin for the three and nine months ended September 30, 2010 was 26% and 24%, respectively, compared to 16% and 15% for the three and nine months ended September 30, 2009, respectively.
     Research and Development Expense. Research and development expense increased by $4.7 million, or 17%, to $32.4 million for the three months ended September 30, 2010, from $27.7 million for the three months ended September 30, 2009. Research and development expense increased by $15.4 million, or 19%, to $96.2 million for the nine months ended September 30, 2010, from $80.8 million for the nine months ended September 30, 2009.
     Research and development expense as a percentage of net revenue was 6% for both the three and nine months ended September 30, 2010, respectively, compared to 5% and 6% for the three and nine months ended September 30, 2009, respectively.
     Sales and Marketing Expense. Sales and marketing expense increased by $9.3 million, or 8%, to $125.6 million for the three months ended September 30, 2010, from $116.3 million for the three months ended September 30, 2009. The increase in sales and marketing expense partially relates to additional spending related to newly-acquired businesses. Amortization expense of $52.7 million and $48.5 million was included in sales and marketing expense for the three months ended September 30, 2010 and 2009, respectively.

45


Table of Contents

     Sales and marketing expense increased by $52.1 million, or 16%, to $369.0 million for the nine months ended September 30, 2010, from $316.9 million for the nine months ended September 30, 2009. The increase in sales and marketing expense partially relates to additional spending related to newly-acquired businesses. Amortization expense of $155.9 million and $133.8 million was included in sales and marketing expense for the nine months ended September 30, 2010 and 2009, respectively.
     Sales and marketing expense as a percentage of net revenue was 23% for both the three and nine months ended September 30, 2010 and 2009.
     General and Administrative Expense. General and administrative expense increased by approximately $9.7 million, or 11%, to $96.1 million for the three months ended September 30, 2010, from $86.4 million for the three months ended September 30, 2009. The increase in general and administrative expense relates primarily to additional spending related to newly-acquired businesses. In addition, we recorded $4.6 million of expense during the three months ended September 30, 2010 in connection with fair value adjustments to acquisition-related contingent consideration obligations in accordance with ASC 805, Business Combinations. Partially offsetting these increases was a decrease in legal spending of approximately $4.7 million for the three months ended September 30, 2010, as compared to the three months ended September 30, 2009. Acquisition-related costs of $0.9 million and $5.1 million was included in general and administrative expense for the three months ended September 30, 2010 and 2009, respectively. Amortization expense of $4.2 million and $5.5 million was included in general and administrative expense for the three months ended September 30, 2010 and 2009, respectively.
     General and administrative expense increased by approximately $36.8 million, or 15%, to $284.2 million for the nine months ended September 30, 2010, from $247.4 million for the nine months ended September 30, 2009. The increase in general and administrative expense relates primarily to additional spending related to newly-acquired businesses. Partially offsetting the increase in spending related to newly-acquired businesses was a decrease in legal spending of approximately $7.9 million for the nine months ended September 30, 2010, as compared to the nine months ended September 30, 2009. In addition, we recorded $2.3 million of income during the nine months ended September 30, 2010 in connection with fair value adjustments to acquisition-related contingent consideration obligations in accordance with ASC 805, Business Combinations. Acquisition-related costs of $6.8 million and $11.5 million was included in general and administrative expense for the nine months ended September 30, 2010 and 2009, respectively. Amortization expense of $13.9 million and $17.0 million was included in general and administrative expense for the nine months ended September 30, 2010 and 2009, respectively.
     General and administrative expense as a percentage of net revenue was 18% for both the three and nine months ended September 30, 2010, compared to 17% and 18% for the three and nine months ended September 30, 2009, respectively.
     Gain on Disposition. In September 2009, we disposed of our majority ownership interest in our Diamics Inc., or Diamics, operation, which was part of our professional diagnostics reporting unit and business segment. During the period from the date of acquisition of Diamics in July 2007 until its disposition in September 2009, under the principles of consolidation, we consolidated 100% of the operating results of the Diamics operations in our consolidated statement of operations. As a result of the disposition, we recorded a gain of $3.4 million during the three and nine months ended September 30, 2009.
     Interest Expense. Interest expense includes interest charges, amortization of deferred financing costs and amortization of original issue discounts associated with certain debt issuances. Interest expense increased by $3.6 million, or 12%, to $34.2 million for the three months ended September 30, 2010, from $30.6 million for the three months ended September 30, 2009. Such increase was principally due to additional interest expense incurred on our 7.875% senior notes and 8.625% subordinated notes, totaling $6.4 million and $1.9 million for the three months ended September 30, 2010 and 2009, respectively.
     Interest expense increased by $28.8 million, or 40%, to $100.9 million for the nine months ended September 30, 2010, from $72.1 million for the nine months ended September 30, 2009. Such increase was principally due to additional interest expense incurred on our 9% subordinated notes, 7.875% senior notes and 8.625% subordinated notes, totaling $46.4 million and $17.1 million for the nine months ended September 30, 2010 and 2009, respectively.

46


Table of Contents

     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 (expense), net are summarized as follows (in thousands):
                                                 
    Three Months Ended             Nine Months Ended        
    September 30,             September 30,        
    2010     2009     Change     2010     2009     Change  
Interest income
  $ 446     $ 586     $ (140 )   $ 1,383     $ 1,509     $ (126 )
Foreign exchange gains (losses), net
    3,297       5,063       (1,766 )     6,680       3,433       3,247  
Other
    3,782       (4,462 )     8,244       6,618       (3,924 )     10,542  
 
                                   
Total other income (expense), net
  $ 7,525     $ 1,187     $ 6,338     $ 14,681     $ 1,018     $ 13,663  
 
                                   
     Foreign exchange gains (losses), net for the three and nine months ended September 30, 2009 includes a $2.9 million net realized foreign currency gain associated with restricted cash established in connection with the acquisition of Concateno during the third quarter of 2009.
     Other income for the three and nine months ended September 30, 2010 includes a net recovery of $3.4 million related to certain restructuring activities. Other income for the nine months ended September 30, 2010 includes a $3.1 million net gain associated with legal settlements related to previously disclosed intellectual property litigation relating to our health management businesses and approximately $0.7 million of income associated with a settlement of prior years’ royalties during 2010, which were partially offset by a charge related to an accounts receivable reserve for a prior year’s sale.
     Other expense of $4.5 million and $3.9 million for the three and nine months ended September 30, 2009, respectively, includes $1.9 million of fully-vested compensation-related expense for certain executives incurred in connection with the acquisition of Concateno during the third quarter of 2009. Additionally, $0.6 million of stamp duty tax incurred in connection with an incremental investment made in one of our foreign subsidiaries was included in other expense for the three and nine months ended September 30, 2009.
     Provision (Benefit) for Income Taxes. The provision (benefit) for income taxes decreased by $6.2 million, to a $0.2 million benefit for the three months ended September 30, 2010, from a $6.0 million provision for the three months ended September 30, 2009. The provision (benefit) for income taxes decreased by $13.9 million, to a $1.0 million benefit for the nine months ended September 30, 2010, from a $12.9 million provision for the nine months ended September 30, 2009. The effective tax rate was 4% and 24% for the three and nine months ended September 30, 2010, compared to 25% and 32% for the three and nine months ended September 30, 2009. The income tax provision (benefit) for the three and nine months ended September 30, 2010 and 2009 relates to federal, foreign and state income tax provisions. The income tax provision decrease for the three and nine months ended September 30, 2010, as compared to the three and nine months ended September 30, 2009, is primarily due to an increase in foreign lower-taxed earnings and a decrease in the future U.K. statutory tax rate from 28% to 27%.
     Equity Earnings in Unconsolidated Entities, Net of Tax. Equity earnings in unconsolidated entities are reported net of tax and includes our share of earnings in entities that we account for under the equity method of accounting. Equity earnings in unconsolidated entities, net of tax, for the three and nine months ended September 30, 2010 reflects the following: (i) income (loss) from our 50% interest in SPD in the amount of $(0.4) million and $6.8 million, respectively, (ii) earnings from our 40% interest in Vedalab S.A., or Vedalab, in the amount of $10,000 and $0.1 million, respectively, and (iii) earnings from our 49% interest in TechLab, Inc., or TechLab, in the amount of $0.4 million and $1.4 million, respectively. Equity earnings in unconsolidated entities, net of tax, for the three and nine months ended September 30, 2009 reflects the following: (i) income from our 50% interest in SPD in the amount of $1.6 million and $4.0 million, respectively, (ii) earnings from our 40% interest in Vedalab in the amount of approximately $28,000 and $0.1 million, respectively, and (iii) earnings from our 49% interest in TechLab, in the amount of $0.5 million and $1.5 million, respectively.

47


Table of Contents

     Income (Loss) from Discontinued Operations, Net of Tax. The results of the vitamins and nutritional supplements business are included in income (loss) from discontinued operations, net of tax, for all periods presented. For the three and nine months ended September 30, 2010, the discontinued operations generated net income of approximately $2,000 and $11.9 million, respectively, as compared to net income of $0.4 million and a net loss of $1.1 million for the three and nine months ended September 30, 2009, respectively. The net income of $11.9 million for the nine months ended September 30, 2010 includes a gain of $19.6 million ($12.0 million, net of tax) on the sale of the vitamins and nutritional supplements business.
     Net Income (Loss) Available to Common Stockholders. For the three months ended September 30, 2010, we generated a net loss available to common stockholders of $2.8 million, or $0.03 per basic and diluted common share, compared to net income available to common stockholders of $14.3 million, or $0.18 per basic common share and $0.17 per diluted common share for the three months ended September 30, 2009. For the nine months ended September 30, 2010, we generated a net loss available to common stockholders of $2.2 million, or $0.03 per basic and diluted common share, compared to net income available to common stockholders of $13.9 million, or $0.17 per basic and diluted common share for the nine months ended September 30, 2009. See Note 5 of the accompanying consolidated financial statements for the calculation of net income per common share.
Liquidity and Capital Resources
     Based upon our current working capital position, current operating plans and expected business conditions, we currently expect to fund our short and long-term working capital needs primarily using existing cash and our operating cash flow, and we expect our working capital position to improve as we improve our operating margins and grow our business through new product and service offerings and by continuing to leverage our strong intellectual property position. As of September 30, 2010, we have $487.6 million of cash on our accompanying consolidated balance sheet. This balance reflects $393.0 million of net proceeds received from our issuance in September 2010 of $400.0 million in aggregate principal amount of our 8.625% senior subordinated notes due 2018, or our 8.625% subordinated notes, as well as approximately $142.0 million used to pay down our revolving line of credit under our secured credit facility.
     In addition to our cash resources, we may also utilize the revolving credit line, under which we have $150.0 million available for borrowing at September 30, 2010, or other sources of financing to fund a portion of our capital needs and other future commitments, including our contractual contingent consideration obligations and future acquisitions. Our ability to access the capital markets may be impacted by the amount of our outstanding debt and equity and the extent to which our assets are encumbered by our outstanding secured debt. The terms and conditions of our outstanding debt instruments also contain covenents which expressly restrict our ability to incur additional indebtedness and conduct other financings. As of September 30, 2010, we had $2.4 billion in outstanding indebtedness comprised of $400.0 million of 8.625% subordinated notes, $244.6 million of 7.875% senior notes due 2016, $389.3 million of 9% senior subordinated notes due 2016, $943.7 million under our First Lien Credit Agreement, $250.0 million under our Second Lien Credit Agreement and $150.0 million of 3% senior subordinated convertible notes. The terms and conditions of our 8.625% subordinated notes are described below, while the terms and conditions of our other outstanding debt are disclosed in Part I, Item 2, “Management’s Discussion and Analysis of Financial Condition and Results of Operations” of our Annual Report on Form 10-K, as amended, for the year ended December 31, 2009 within our discussion of Liquidity and Capital Resources.
     At September 30, 2010, our liquidity has not been materially impacted by the recent and unprecedented disruption in the capital and credit markets and we do not expect that it will be materially impacted in the near future. However if the capital and credit markets continue to experience volatility and the availability of funds remains limited, we may incur increased costs associated with issuing commercial paper and/or other debt instruments. In addition, it is possible that our ability to access the capital and credit markets may be limited by these or other factors at a time when we would like, or need, to do so, which could have an impact on our ability to refinance maturing debt and/or react to changing economic and business conditions.
     Our funding plans for our working capital needs and other commitments may be adversely impacted by unexpected costs associated with integrating the operations of newly-acquired companies, executing our cost savings strategies and prosecuting and defending our existing lawsuits and/or unforeseen lawsuits against us. 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

48


Table of Contents

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.
     8.625% Senior Subordinated Notes
     On September 21, 2010, we completed the sale of $400.0 million aggregate principal amount of the 8.625% subordinated notes due 2018, or the 8.625% subordinated notes, in a private placement to initial purchasers, who agreed to resell the notes only to qualified institutional buyers and to persons outside the United States. The proceeds from this offering amounted to $393.0 million, which was net of underwriter’s commissions totaling $7.0 million. The proceeds are intended to be used for working capital and other general corporate purposes. At September 30, 2010, we had $400.0 million in indebtedness under our 8.625% subordinated notes.
     The 8.625% subordinated notes, which were issued under a supplemental indenture dated September 21, 2010, as amended or supplemented, the September 2010 Indenture, accrue interest from the date of their issuance, at the rate of 8.625% per year. Interest on the notes is payable semi-annually on April 1 and October 1, commencing on April 1, 2011. The notes mature on October 1, 2018, unless earlier redeemed.
     We may redeem the 8.625% subordinated notes, in whole or part, at any time (which may be more than once) on or after October 1, 2014, by paying the principal amount of the notes being redeemed plus a declining premium, plus accrued and unpaid interest to, but excluding, the redemption date. The premium declines from 4.313% during the twelve months on and after October 1, 2014 to 2.156% during the twelve months on and after October 1, 2015 to zero on and after October 1, 2016. Prior to October 1, 2013, we may redeem, in whole or part, at any time (which may be more than once), up to 35% of the aggregate principal amount of the 8.625% subordinated notes with money that we raise in certain equity offerings so long as (i) we pay 108.625% of the principal amount of the notes being redeemed, plus accrued and unpaid interest to (but excluding) the redemption date; (ii) we redeem the notes within 90 days of completing such equity offering; and (iii) at least 65% of the aggregate principal amount of the 8.625% subordinated notes, including any 8.625% subordinated notes issued after September 21, 2010, remains outstanding afterwards. In addition, at any time prior to October 1, 2014, we may redeem some or all of the 8.625% subordinated notes by paying the principal amount of the notes being redeemed plus the payment of a make-whole premium, plus accrued and unpaid interest to, but excluding, the redemption date.
     If a change of control occurs, subject to specified conditions, we must give holders of the 8.625% subordinated notes an opportunity to sell their notes to us at a purchase price of 101% of the principal amount of the notes, plus accrued and unpaid interest to, but excluding, the date of the purchase.
     If we or our subsidiaries engage in asset sales, we or they generally must either invest the net cash proceeds from such sales in our or their businesses within a specified period of time, repay senior indebtedness or make an offer to purchase a principal amount of the 8.625% subordinated notes equal to the excess net cash proceeds, subject to certain exceptions. The purchase price of the notes will be 100% of their principal amount, plus accrued and unpaid interest.
     The 8.625% subordinated notes are unsecured and are subordinated in right of payment to all of our existing and future senior debt, including our borrowing under our secured credit facilities. Our obligations under the 8.625% subordinated notes and the September 2010 Indenture are fully and unconditionally guaranteed, jointly and severally, on an unsecured senior subordinated basis by certain of our domestic subsidiaries, and the obligations of such domestic subsidiaries under their guarantees are subordinated in right of payment to all of their existing and future senior debt. See Note 22 of the accompanying consolidated financial statements for guarantor financial information.
     The September 2010 Indenture contains covenants that will limit our ability and the ability of our subsidiaries to, among other things, incur additional debt; pay dividends on capital stock or redeem, repurchase or retire capital

49


Table of Contents

stock or subordinated debt; make certain investments; create liens on assets; transfer or sell assets; engage in transactions with affiliates; create restrictions on our or their ability to pay dividends or make loans, asset transfers or other payments to us or them; issue capital stock of our or their subsidiaries; engage in any business, other than our or their existing businesses and related businesses; enter into sale and leaseback transactions; incur layered indebtedness; and consolidate, merge or transfer all or substantially all of our or their assets, taken as a whole. These covenants are subject to certain exceptions and qualifications.
Summary of Changes in Cash Position
     As of September 30, 2010, we had cash and cash equivalents of $487.6 million, a $5.2 million decrease from December 31, 2009. Our primary sources of cash during the nine months ended September 30, 2010 included $229.3 million generated by our operating activities, $393.0 million of net proceeds from the issuance of our 8.625% subordinated notes, $63.4 million received from the sale of our vitamins and nutritional supplements business, an $8.8 million return of capital from SPD, and $17.8 million from common stock issuances under employee stock option and stock purchase plans. Our primary uses of cash during the nine months ended September 30, 2010 related to $465.6 million net cash paid for acquisitions and transactional costs, $17.9 million of net purchases of marketable securities, $147.0 million related to net repayments under our revolving line of credit, $67.8 million of capital expenditures, net of proceeds from the sale of equipment and $7.3 million in repayment of long-term debt. Fluctuations in foreign currencies negatively impacted our cash balance by $9.0 million during the nine months ended September 30, 2010.
     Cash Flows from Operating Activities
     Net cash provided by operating activities during the nine months ended September 30, 2010 was $229.3 million, which resulted from net income from continuing operations of $5.1 million and $267.8 million of non-cash items, offset by $43.6 million of cash used to meet net working capital requirements during the period. The $267.8 million of non-cash items included, among various other items, $275.5 million related to depreciation and amortization, $22.9 million related to non-cash stock-based compensation expense and $10.3 million of interest expense related to the amortization of deferred financing costs and original issue discounts, partially offset by a $33.3 million decrease primarily related to changes in our deferred tax assets and deferred tax liabilities for current year losses and tax loss carryforwards and $8.2 million in equity earnings in unconsolidated entities.
Cash Flows from Investing Activities
     Our investing activities during the nine months ended September 30, 2010 utilized $478.7 million of cash, including $465.6 million net cash paid for acquisitions and transaction-related costs, $17.9 million of net purchases of marketable securities and $67.8 million of capital expenditures, net of proceeds from the sale of equipment, offset by $63.4 million received for the sale of our vitamins and nutritional supplements business and a $8.8 million net decrease in investments and other assets, which was primarily driven by an $8.8 million return of capital from SPD.
Cash Flows from Financing Activities
     Net cash provided by financing activities during the nine months ended September 30, 2010 was $253.2 million. Financing activities during the nine months ended September 30, 2010 primarily included $400.0 million of proceeds from the issuance of our 8.625% subordinated notes, $17.8 million of cash received from common stock issuances under employee stock option and stock purchase plans and $1.3 million related to the excess tax benefit on exercised stock options, offset by $147.0 million related to net repayments under our revolving lines-of-credit, $7.3 million in repayments of long-term debt and $9.6 million paid for financing costs related to certain debt issuances.
     As of September 30, 2010, we had an aggregate of $2.8 million in outstanding capital lease obligations which are payable through 2015.
Income Taxes
     As of December 31, 2009, we had approximately $184.5 million of domestic net operating loss, or NOL, and capital loss carryforwards and $33.5 million of foreign NOL and capital loss carryforwards, respectively, which either expire on various dates through 2028 or may be carried forward indefinitely. These losses are available to

50


Table of Contents

reduce federal, state 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 NOL carryforward amount at December 31, 2009 included approximately $143.3 million of pre-acquisition losses at Matria Healthcare, Inc., QAS, ParadigmHealth, Inc., Biosite Incorporated, Cholestech Corporation, Redwood Toxicology Laboratory, Inc., HemoSense, Inc., Inverness Medical Nutritionals Group, Ischemia, Inc. and Ostex International, Inc. Effective January 1, 2009, we adopted a new accounting standard for business combinations. Prior to adoption of this standard, the pre-acquisition losses were 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. Upon adoption of the new accounting standard, the reduction of a valuation allowance is generally recorded to reduce our income tax expense.
     Furthermore, all domestic losses are subject to the Internal Revenue 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 NOLs 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 September 30, 2010.
Contractual Obligations
     The following table summarizes our principal contractual obligations as of September 30, 2010 that have changed materially since December 31, 2009 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, as amended, for the year ended December 31, 2009, but omitted in the table below, represent those that have not changed materially since that date (in thousands).
                                         
    Payments Due by Period  
    Total     2010     2011-2012     2013-2014     Thereafter  
Contractual Obligations
                                       
Interest on debt(1)
  $ 644,550     $ 21,469     $ 188,713     $ 193,352     $ 241,016  
 
                             
 
(1)   Includes our non-variable interest-bearing debt.
     In addition, we have contractual contingent consideration obligations related to the following acquisitions:
    Accordant has a maximum earn-out of $6.0 million that, if earned, will be paid in quarterly payments of $1.5 million beginning in the fourth quarter of 2012.
 
    Ameditech, Inc., or Ameditech, has a maximum earn-out of $4.0 million that, if earned, will be paid during 2010 and 2011.
 
    Free & Clear has a maximum earn-out of $30.0 million that, if earned, will be paid in 2011.
 
    Immunalysis has a maximum earn-out of $5.0 million that, if earned, will be paid in 2011 through 2013.
     Additionally, we have a contractual contingent obligation to pay up to a total of $3.0 million in compensation to certain executives of Immunalysis in accordance with the acquisition agreement that, if earned, will be paid out in connection with the contingent consideration payable to the former shareholders of Immunalysis, in each of the calendar years 2010, 2011 and 2012.
     In no case, will the aggregate total of the two contingent obligations noted above exceed $6.0 million.

51


Table of Contents

    A privately-owned research and development operation has a maximum earn-out of $57.5 million that, if earned, will be paid in 2011 through 2014.
 
    Jinsung Meditech, Inc., or JSM, has a maximum earn-out of $3.0 million that, if earned, will be paid in annual amounts during 2011 through 2013.
 
    Mologic Limited, or Mologic, has a maximum earn-out of $19.0 million that, if earned, will be paid in annual amounts during 2011 and 2012, and is payable in shares of our common stock.
 
    Tapestry has a maximum earn-out of $25.0 million that, if earned, will be paid in annual amounts during 2011 and 2012. The earn-out is to be paid in shares of our common stock, except in the case that the 2010 financial targets defined under the agreement and plan of merger are exceeded, in which case the seller may elect to be paid the earn-out relating to the 2010 financial targets in cash. If the seller elects to be paid in cash, the earn-out will be capped at $20.0 million.
 
    A privately-owned U.K. research and development operation has a maximum earn-out of up to $125.0 million that, if earned, is expected to be paid during an eight-year period ending on the eighth anniversary of the acquisition, but could extend thereafter.
 
    The privately-owned health management business acquired in 2008 has an earn-out that, if earned, will be paid in 2011.
     For further information pertaining to our contractual contingent consideration obligations see Note 17 of our accompanying consolidated financial statements.
    Agreements with Epocal
     In November 2009, we entered into a distribution agreement with Epocal, Inc., or Epocal, to distribute the epoc® Blood Analysis System for blood gas and electrolyte testing for $20.0 million, which is recorded on our accompanying consolidated balance sheet in other intangible assets, net. We also entered into a definitive agreement to acquire all of the issued and outstanding equity securities of Epocal for a total potential purchase price of up to $255.0 million, including a base purchase price of up to $172.5 million if Epocal achieves certain gross margin and other financial milestones on or prior to October 31, 2014, plus additional payments of up to $82.5 million if Epocal achieves certain other milestones relating to its gross margin and product development efforts on or prior to this date. We also agreed that, if the acquisition is consummated, we will provide $12.5 million in management incentive arrangements, 25% of which will vest over three years and 75% of which will be payable only upon the achievement of certain milestones. The acquisition will also be subject to other closing conditions, including the receipt of any required antitrust or other approvals.
    Option agreement with P&G
     In connection with the formation of SPD in May 2007, we entered into an option agreement with P&G, pursuant to which P&G has the right, for a period of 60 days commencing on the fourth anniversary date of the agreement, to require us to acquire all of P&G’s interest in SPD at fair market value, and P&G has the right, upon certain material breaches by us of our obligations to SPD, to acquire all of our interest in SPD at fair market value. No gain on the proceeds that we received from P&G through the formation of SPD will be recognized in our financial statements until P&G’s option to require us to purchase its interest in SPD expires. If P&G chooses to exercise its option, the deferred gain carried on our books would be reversed in connection with the repurchase transaction. As of September 30, 2010, the deferred gain of $288.6 million is presented as a current liability on our accompanying consolidated balance sheet.

52


Table of Contents

    Put arrangement with minority shareholder in Standard Diagnostics
     We entered into a put arrangement as part of a shareholder agreement with respect to the common securities that represent the 21.25% non-controlling interest of a certain minority shareholder in Standard Diagnostics. This put arrangement is exercisable at KRW 40,000 per share by the counterparty upon the occurrence of certain events which are outside of our control. As a result, this non-controlling interest is classified as mezzanine equity on our accompanying consolidated balance sheet as of September 30, 2010. The redeemable non-controlling interest was recorded at its fair value of KRW 57.9 billion, or $49.2 million, as of the consummation of the transaction on February 8, 2010. The redeemable put arrangement has an estimated redemption price of KRW 65.4 billion, or $56.9 million, as of September 30, 2010. The redeemable non-controlling interest will be accreted to the redemption price, through equity, at the point at which the redemption becomes probable. In addition, if the put is exercised, we will incur a penalty in the amount of KRW 63.0 billion, or approximately $54.8 million at September 30, 2010, which will be accounted for as compensation expense at the time of exercise. On October 30, 2010, we entered into an agreement with this minority shareholder whereby we would purchase all of this shareholder’s remaining shares in Standard Diagnostics for a total purchase price of KRW 125.4 billion, or approximately $111.6 million at October 30, 2010. This share purchase transaction was completed on November 5, 2010, which included the termination of the put arrangement. We will account for KRW 65.4 billion, or approximately $58.2 million at November 5, 2010, of the transaction consideration as purchase price and KRW 60.0 billion, or approximately $53.4 million at November 5, 2010, as compensation expense as a result of the transition of the day-to-day management control of the business to us and the termination of the put arrangement.
    Other commitments
     We entered into an arrangement to acquire the shares of Bionote, a veterinary business, for approximately $31.0 million and an arrangement to sell Standard Diagnostics’ Biosensor glucose and lipid product line business for approximately $9.0 million. We expect to complete these transactions late in 2010 or early 2011.
Critical Accounting Policies
     The discussion and analysis of our financial condition and results of operations is based on our consolidated financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States. The preparation of these financial statements in accordance with generally accepted accounting principles requires us to make estimates and judgments that may affect the reported amounts of assets, liabilities, revenues and expenses, and related disclosure of contingent assets and liabilities. On a quarterly basis, we evaluate our estimates, including those related to revenue recognition and related allowances, bad debt, inventory, valuation of long-lived assets, including intangible assets and goodwill, income taxes, including any valuation allowance for our net deferred tax assets, contingencies and litigation, and stock-based compensation. We base our estimates on historical experience and on various other assumptions that are believed to be reasonable, the results of which form the basis for making judgments about the carrying values of assets and liabilities. Actual results may differ from these estimates under different assumptions or conditions.
     There have been no significant changes in our critical accounting policies or management estimates since the year ended December 31, 2009. A comprehensive discussion of our critical accounting policies and management estimates is included in Management’s Discussion and Analysis of Financial Condition and Results of Operations in our Annual Report on Form 10-K, as amended, for the year ended December 31, 2009.
Recent Accounting Pronouncements
     See Note 18 in the notes to the consolidated financial statements included in this Quarterly Report on Form 10-Q regarding the impact of certain recent accounting pronouncements on our consolidated financial statements.
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
     The following discussion of 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.

53


Table of Contents

     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 September 30, 2010, the carrying value of our short-term investments approximated market value.
     At September 30, 2010, we had term loans in the amount of $943.7 million and a revolving line of credit available to us of up to $150.0 million, of which there were no outstanding borrowings as of September 30, 2010, under our First Lien Credit Agreement. Interest on these term loans, as defined in the credit agreement, is as follows: (i) in the case of Base Rate Loans, at a rate per annum equal to the sum of the Base Rate and the Applicable Margin, each as in effect from time to time, (ii) in the case of Eurodollar Rate Loans, at a rate per annum equal to the sum of the Eurodollar Rate and the Applicable Margin, each as in effect for the applicable Interest Period, and (iii) in the case of other Obligations, at a rate per annum equal to the sum of the Base Rate and the Applicable Margin for Revolving Loans that are Base Rate Loans, each as in effect from time to time. The Base Rate is a floating rate which approximates the U.S. Prime rate and changes on a periodic basis. The Eurodollar Rate is equal to the LIBOR rate and is set for a period of one to three months at our election. Applicable margin with respect to Base Rate Loans is 1.00% and with respect to Eurodollar Rate Loans is 2.00%. Applicable margin ranges for our revolving line of credit with respect to Base Rate Loans is 0.75% to 1.25% and with respect to Eurodollar Rate Loans is 1.75% to 2.25%.
     At September 30, 2010, we also had term loans in the amount of $250.0 million under our Second Lien Credit Agreement. Interest on these term loans, as defined in the credit agreement, is as follows: (i) in the case of Base Rate Loans, at a rate per annum equal to the sum of the Base Rate and the Applicable Margin, each as in effect from time to time, (ii) in the case of Eurodollar Rate Loans, at a rate per annum equal to the sum of the Eurodollar Rate and the Applicable Margin, each as in effect for the applicable Interest Period, and (iii) in the case of other Obligations, at a rate per annum equal to the sum of the Base Rate and the Applicable Margin for Base Rate Loans, as in effect from time to time. Applicable margin with respect to Base Rate Loans is 3.25% and with respect to Eurodollar Rate Loans is 4.25%.
     In August 2007, we entered into interest rate swap contracts, with an effective date of September 28, 2007, that have a total notional value of $350.0 million and a maturity date of September 28, 2010. These interest rate swap contracts pay us variable interest at the three-month LIBOR rate, and we pay the counterparties a fixed rate of 4.85%. In March 2009, we extended our August 2007 interest rate hedge for an additional two-year period commencing in September 2010 at a one-month LIBOR rate of 2.54%. These interest rate swap contracts were entered into to convert $350.0 million of the $1.2 billion variable rate term loans under the senior credit facility into fixed rate debt.
     In January 2009, we entered into interest rate swap contracts, with an effective date of January 14, 2009, that have a total notional value of $500.0 million and a maturity date of January 5, 2011. These interest rate swap contracts pay us variable interest at the one-month LIBOR rate, and we pay the counterparties a fixed rate of 1.195%. These interest rate swap contracts were entered into to convert $500.0 million of the $1.2 billion variable rate term loans under the secured credit facility into fixed rate debt.
     Assuming no changes in our leverage ratio, which would affect the margin of the interest rates under the credit agreements, the effect of interest rate fluctuations on outstanding borrowings as of September 30, 2010 over the next twelve months is quantified and summarized as follows (in thousands):
         
    Interest Expense
    Increase
Interest rates increase by 100 basis points
  $ 7,187  
Interest rates increase by 200 basis points
  $ 14,374  
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 nine months ended September 30, 2010, the net impact of foreign

54


Table of Contents

currency changes on transactions was a gain of $3.3 million and $6.7 million, respectively. 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 foreign plants and sell in U.S. Dollars and manufactured by our U.S. plants and sold in currencies other than the U.S. dollar are also affected by foreign currency exchange rate movements. Our gross margin on total net product sales was 53.1% for the three months ended September 30, 2010. If the U.S. Dollar had been stronger by 1%, 5% or 10%, compared to the actual rates during the three months ended September 30, 2010, our gross margin on total net product sales would have been 53.1%, 53.4% or 53.7%, respectively. Our gross margin on total net product sales was 52.9% for the nine months ended September 30, 2010. If the U.S. Dollar had been stronger by 1%, 5% or 10%, compared to the actual rates during the nine months ended September 30, 2010, our gross margin on total net product sales would have been 53.0%, 53.2% or 53.5%, 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 uniformly stronger by 1%, 5% or 10%, compared to the actual average exchange rates used to translate the financial results of each of our foreign subsidiaries, our net product sales revenue and our net income would have been impacted by approximately the following amounts (in thousands):
                 
    Approximate   Approximate
    decrease in net   decrease in net
If, during the three months ended September 30, 2010, the U.S. dollar was stronger by:   revenue   income
1%
  $ 1,501     $ 107  
5%
  $ 7,506     $ 536  
10%
  $ 15,011     $ 1,072  
                 
    Approximate   Approximate
    decrease in net   decrease in net
If, during the nine months ended September 30, 2010, the U.S. dollar was stronger by:   revenue   income
1%
  $ 4,402     $ 410  
5%
  $ 22,010     $ 2,052  
10%
  $ 44,019     $ 4,103  

55


Table of Contents

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 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 report. Based on this evaluation, our management, including the CEO and CFO, concluded that our 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 most recent fiscal quarter covered by this report that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
PART II — OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
     There are no material changes or additions to any of the material pending legal proceedings or other matters previously disclosed in Part I, Item 3, “Legal Proceedings,” of our Annual Report on Form 10-K, as amended, for the year ended December 31, 2009, or in Part II, Item 1, “Legal Proceedings” of any Quarterly Report filed subsequent to the Annual Report on Form 10-K.
ITEM 1A. RISK FACTORS
     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, as amended, for the fiscal year ending December 31, 2009, or in Part II, Item 1A, “Risk Factors” of any Quarterly Report filed subsequent to the Annual Report on Form 10-K. We note, however, that the risk factors relating to our substantial indebtedness and the agreements governing our indebtedness which are set forth in our Annual Report on Form 10-K, as amended, apply also to the $400.0 million in aggregate principal amount of additional indebtedness incurred on September 21, 2010 pursuant to the issuance of our 8.625% subordinated notes, and the indenture governing those notes, as well as to other debt which we have incurred or may incur.
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
     During the period covered by this report, we issued 843 shares of our common stock upon the exercise of warrants for cash, resulting in aggregate proceeds to us of $5,092. These shares were offered and sold in 15 separate transactions pursuant to exemptions from registration afforded by Section 4(2) of the Securities Act of 1933, as amended. These warrants were either issued in 2001 in connection with our formation or issued or assumed by us in private placements relating to various acquisitions.

56


Table of Contents

ITEM 6. EXHIBITS
Exhibits:
     
Exhibit No.   Description
1.1
  Purchase Agreement dated September 15, 2010 among Alere Inc., the subsidiary guarantors named therein and Jefferies & Company, Inc., Goldman, Sachs & Co. and Citigroup Global Markets Inc., as Representatives of the Initial Purchasers (incorporated by reference to Exhibit 1.1 to the Company’s Current Report on Form 8-K, event date September 15, 2010, filed with the SEC on September 21, 2010)
 
   
3.1
  Amended and Restated Certificate of Incorporation of the Company, as amended (incorporated by reference to Exhibit 3.1 of the Company’s Quarterly Report on Form 10-Q for the period ended June 30, 2010)
 
   
4.1
  Ninth Supplemental Indenture dated September 21, 2010 among Alere Inc., as issuer, the subsidiary guarantors named therein, as guarantors, and U.S. Bank National Association, as trustee (incorporated by reference to Exhibit 4.2 to the Company’s Current Report on Form 8-K, event date September 15, 2010, filed with the SEC on September 21, 2010)
 
   
4.2
  Form of 8.625% Senior Subordinated Note due 2018 (included in Exhibit 4.1 above)
 
   
4.3
  Registration Rights Agreement dated September 21, 2010 among Alere Inc., the subsidiary guarantors named therein and Jefferies & Company, Inc., Goldman, Sachs & Co. and Citigroup Global Markets Inc., as Representatives of the Initial Purchasers (incorporated by reference to Exhibit 4.4 to the Company’s Current Report on Form 8-K, event date September 15, 2010, filed September 21, 2010)
 
   
10.1
  Alere Inc. 2010 Stock Option and Incentive Plan (incorporated by reference to Exhibit 10.1 of the Company’s Quarterly Report on Form 10-Q for the period ended June 30, 2010)
 
   
*10.2
  Form of Non-Qualified Stock Option Agreement for Non-Employee Directors under the Alere Inc. 2010 Stock Option and Incentive Plan
 
   
*10.3
  Form of Non-Qualified Stock Option Agreement for Non-Employee Directors Outside of the U.S. under the Alere Inc. 2010 Stock Option and Incentive Plan
 
   
*10.4
  Form of Incentive Stock Option Agreement for Executives under the Alere Inc. 2010 Stock Option and Incentive Plan
 
   
*10.5
  Form of Non-Qualified Stock Option Agreement for U.S. Executives under the Alere Inc. 2010 Stock Option and Incentive Plan
 
   
*10.6
  Form of Non-Qualified Stock Option Agreement for Non-U.S. Executives under the Alere Inc. 2010 Stock Option and Incentive Plan
 
   
10.7
  Rules of Alere Inc. HM Revenue and Customs Approved Share Option Plan (2007), as amended (authorized for use under the Alere Inc. 2001 Stock Option and Incentive Plan and the Alere Inc. 2010 Stock Option and Incentive Plan) (incorporated by reference to Exhibit 10.5 of the Company’s Quarterly Report on Form 10-Q for the period ended June 30, 2010)
 
   
*10.8
  Summary of Non-Employee Director Compensation
 
   
*31.1
  Certification by Chief Executive Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
 
   
*31.2
  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
 
   
*101
  Interactive Data Files regarding (a) our Consolidated Statements of Operations for the Three and Nine Months Ended September 30, 2010 and 2009, (b) our Consolidated Balance Sheets as of September 30, 2010 and December 31, 2009, (c) our Consolidated Statements of Cash Flows for the Nine Months Ended September 30, 2010 and 2009 and (d) the Notes to such Consolidated Financial Statements.
 
*   Filed herewith

57


Table of Contents

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.
         
 
  ALERE INC.    
 
       
Date: November 8, 2010
  /s/ David Teitel
 
David Teitel
   
 
  Chief Financial Officer and an authorized officer    

58