FORM 10-Q
Table of Contents

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

 

FORM 10-Q

 

 

(Mark One)

x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended March 31, 2012

OR

 

¨ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from             to             

COMMISSION FILE NUMBER 001-16789

 

 

 

LOGO

ALERE INC.

(Exact name of registrant as specified in its charter)

 

 

 

DELAWARE   04-3565120

(State or other jurisdiction of

incorporation or organization)

 

(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  x    No  ¨

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§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  x    No  ¨

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act. (Check one):

 

Large accelerated filer   x    Accelerated filer   ¨
Non-accelerated filer   ¨  (Do not check if a smaller reporting company)    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  ¨    No  x

The number of shares outstanding of the registrant’s common stock, par value of $0.001 per share, as of May 7, 2012 was 80,369,516.

 

 

 


Table of Contents

ALERE INC.

REPORT ON FORM 10-Q

For the Quarterly Period Ended March 31, 2012

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 for the fiscal year ended December 31, 2011 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  
PART I. FINANCIAL INFORMATION      3   

Item 1. Unaudited Financial Statements

     3   

a) Consolidated Statements of Operations for the Three Months Ended March 31, 2012 and 2011

     3   

b) Consolidated Statements of Comprehensive Income for the Three Months Ended March 31, 2012 and 2011

     4   

c) Consolidated Balance Sheets as of March 31, 2012 and December 31, 2011

     5   

d) Consolidated Statements of Cash Flows for the Three Months Ended March 31, 2012 and 2011

     6   

e) Notes to Consolidated Financial Statements

     7   

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

     31   

Item 3. Quantitative and Qualitative Disclosures About Market Risk

     38   

Item 4. Controls and Procedures

     40   
PART II. OTHER INFORMATION      40   

Item 1. Legal Proceedings

     40   

Item 1A. Risk Factors

     40   

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds

     40   

Item 6. Exhibits

     41   
SIGNATURES      42   

 

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 March 31,  
     2012     2011  

Net product sales

   $ 475,787      $ 407,243   

Services revenue

     192,434        167,552   
  

 

 

   

 

 

 

Net product sales and services revenue

     668,221        574,795   

License and royalty revenue

     2,908        7,669   
  

 

 

   

 

 

 

Net revenue

     671,129        582,464   
  

 

 

   

 

 

 

Cost of net product sales

     225,554        189,687   

Cost of services revenue

     90,860        84,716   
  

 

 

   

 

 

 

Cost of net product sales and services revenue

     316,414        274,403   

Cost of license and royalty revenue

     1,644        1,854   
  

 

 

   

 

 

 

Cost of net revenue

     318,058        276,257   
  

 

 

   

 

 

 

Gross profit

     353,071        306,207   

Operating expenses:

    

Research and development

     39,000        36,542   

Sales and marketing

     158,578        133,209   

General and administrative

     120,435        105,551   
  

 

 

   

 

 

 

Total operating expenses

     318,013        275,302   
  

 

 

   

 

 

 

Operating income

     35,058        30,905   

Interest expense, including amortization of original issue discounts and deferred financing costs

     (50,727     (38,305

Other income (expense), net

     11,831        2,336   
  

 

 

   

 

 

 

Loss before benefit for income taxes

     (3,838     (5,064

Benefit for income taxes

     (1,455     (4,330
  

 

 

   

 

 

 

Loss before equity earnings of unconsolidated entities, net of tax

     (2,383     (734

Equity earnings of unconsolidated entities, net of tax

     3,412        1,011   
  

 

 

   

 

 

 

Net income

     1,029        277   

Less: Net income (loss) attributable to non-controlling interests

     (185     62   
  

 

 

   

 

 

 

Net income attributable to Alere Inc. and Subsidiaries

     1,214        215   

Preferred stock dividends

     (5,309     (5,809

Preferred stock repurchase

     —          13,688   
  

 

 

   

 

 

 

Net income (loss) available to common stockholders

   $ (4,095   $ 8,094   
  

 

 

   

 

 

 

Basic net income (loss) per common share attributable to Alere Inc. and Subsidiaries:

   $ (0.05   $ 0.09   
  

 

 

   

 

 

 

Diluted net income (loss) per common share attributable to Alere Inc. and Subsidiaries:

   $ (0.05   $ 0.09   
  

 

 

   

 

 

 

Weighted-average shares-basic

     80,240        85,362   
  

 

 

   

 

 

 

Weighted-average shares-diluted

     80,240        86,953   
  

 

 

   

 

 

 

The accompanying notes are an integral part of these consolidated financial statements.

 

3


Table of Contents

ALERE INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME

(unaudited)

(in thousands)

 

     Three Months Ended March 31,  
     2012     2011  

Net income

   $ 1,029      $ 277   
  

 

 

   

 

 

 

Other comprehensive income, before tax:

    

Changes in cumulative translation adjustment

     35,939        21,515   

Unrealized gains (losses) on available for sale securities

     431        (215

Unrealized gains on hedging instruments

     1,107        1,617   

Minimum pension liability adjustment

     (165     (38
  

 

 

   

 

 

 

Other comprehensive income, before tax

     37,312        22,879   

Income tax provision (benefit) related to items of other comprehensive income

     (41     619   
  

 

 

   

 

 

 

Other comprehensive income, net of tax

     37,353        22,260   
  

 

 

   

 

 

 

Comprehensive income

     38,382        22,537   

Less: Comprehensive income (loss) attributable to non-controlling interests

     (185     62   
  

 

 

   

 

 

 

Comprehensive income attributable to Alere Inc. and Subsidiaries

   $ 38,567      $ 22,475   
  

 

 

   

 

 

 

The accompanying notes are an integral part of these consolidated financial statements.

 

4


Table of Contents

ALERE INC. AND SUBSIDIARIES

CONSOLIDATED BALANCE SHEETS

(unaudited)

(in thousands, except par value)

 

     March 31, 2012     December 31, 2011  
ASSETS     

Current assets:

    

Cash and cash equivalents

   $ 514,097      $ 299,173   

Restricted cash

     2,684        8,987   

Marketable securities

     1,092        1,086   

Accounts receivable, net of allowances of $29,021 and $24,577 at March 31, 2012 and December 31, 2011, respectively

     489,262        475,824   

Inventories, net

     309,921        320,269   

Deferred tax assets

     40,790        42,975   

Receivable from joint venture, net

     2,137        2,503   

Prepaid expenses and other current assets

     136,572        142,910   
  

 

 

   

 

 

 

Total current assets

     1,496,555        1,293,727   

Property, plant and equipment, net

     506,507        491,205   

Goodwill

     2,835,171        2,821,271   

Other intangible assets with indefinite lives

     72,434        69,546   

Finite-lived intangible assets, net

     1,756,233        1,785,925   

Deferred financing costs, net, and other non-current assets

     107,148        97,786   

Receivable from joint venture, net of current portion

     15,977        15,455   

Investments in unconsolidated entities

     85,392        85,138   

Marketable securities

     2,684        2,254   

Deferred tax assets

     11,180        10,394   
  

 

 

   

 

 

 

Total assets

   $ 6,889,281      $ 6,672,701   
  

 

 

   

 

 

 
LIABILITIES AND EQUITY     

Current liabilities:

    

Current portion of long-term debt

   $ 62,932      $ 61,092   

Current portion of capital lease obligations

     5,796        6,083   

Short-term debt

     —          6,240   

Accounts payable

     139,523        155,464   

Accrued expenses and other current liabilities

     397,449        395,573   
  

 

 

   

 

 

 

Total current liabilities

     605,700        624,452   
  

 

 

   

 

 

 

Long-term liabilities:

    

Long-term debt, net of current portion

     3,453,583        3,267,451   

Capital lease obligations, net of current portion

     11,726        12,629   

Deferred tax liabilities

     371,190        380,700   

Other long-term liabilities

     168,301        153,398   
  

 

 

   

 

 

 

Total long-term liabilities

     4,004,800        3,814,178   
  

 

 

   

 

 

 

Commitments and contingencies (Note 16)

    

Redeemable non-controlling interest

     2,448        2,497   
  

 

 

   

 

 

 

Stockholders’ equity:

    

Series B preferred stock, $0.001 par value (liquidation preference: $709,763 at March 31, 2012 and December 31, 2011); Authorized: 2,300 shares; Issued: 2,065 shares at March 31, 2012 and December 31, 2011; Outstanding: 1,774 shares at March 31, 2012 and December 31, 2011

     606,468        606,468   

Common stock, $0.001 par value; Authorized: 200,000 shares; Issued: 88,025 shares at March 31, 2012 and 87,647 shares at December 31, 2011; Outstanding: 80,346 shares at March 31, 2012 and 79,968 shares at December 31, 2011

     88        88   

Additional paid-in capital

     3,331,039        3,324,710   

Accumulated deficit

     (1,485,577     (1,486,791

Treasury stock, at cost, 7,679 shares at March 31, 2012 and December 31, 2011

     (184,971     (184,971

Accumulated other comprehensive income (loss)

     7,083        (30,270
  

 

 

   

 

 

 

Total stockholders’ equity

     2,274,130        2,229,234   

Non-controlling interests

     2,203        2,340   
  

 

 

   

 

 

 

Total equity

     2,276,333        2,231,574   
  

 

 

   

 

 

 

Total liabilities and equity

   $ 6,889,281      $ 6,672,701   
  

 

 

   

 

 

 

The accompanying notes are an integral part of these consolidated financial statements.

 

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Table of Contents

ALERE INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF CASH FLOWS

(unaudited)

(in thousands)

 

     Three Months Ended March31,  
     2012     2011  

Cash Flows from Operating Activities:

    

Net income

   $ 1,029      $ 277   

Adjustments to reconcile net income to net cash provided by operating activities:

    

Non-cash interest expense, including amortization of original issue discounts and write-off of deferred financing costs

     5,278        3,603   

Depreciation and amortization

     107,402        94,975   

Non-cash stock-based compensation expense

     3,874        5,808   

Impairment of inventory

     5        294   

Impairment of long-lived assets

     134        230   

Impairment of intangible assets

     —          2,935   

Loss on sale of fixed assets

     566        479   

Gain on sales of marketable securities

     —          (333

Equity earnings of unconsolidated entities, net of tax

     (3,412     (1,011

Deferred income taxes

     (13,752     (13,238

Other non-cash items

     —          1,606   

Changes in assets and liabilities, net of acquisitions:

    

Accounts receivable, net

     (12,942     (5,339

Inventories, net

     9,351        11,063   

Prepaid expenses and other current assets

     3,521        (24,473

Accounts payable

     (17,806     (5,935

Accrued expenses and other current liabilities

     3,985        14,795   

Other non-current liabilities

     14,697        1,424   
  

 

 

   

 

 

 

Net cash provided by operating activities

     101,930        87,160   
  

 

 

   

 

 

 

Cash Flows from Investing Activities:

    

Decrease in restricted cash

     6,302        3   

Purchases of property, plant and equipment

     (30,385     (28,944

Proceeds from sale of property, plant and equipment

     527        204   

Proceeds from disposition of business

     —          11,490   

Cash paid for acquisitions, net of cash acquired

     (38,008     (94,899

Cash received from equity method investment

     6,066        —     

Cash received (paid) for marketable securities

     (2     6,982   

Increase in other assets

     (8,554     (12,102
  

 

 

   

 

 

 

Net cash used in investing activities

     (64,054     (117,266
  

 

 

   

 

 

 

Cash Flows from Financing Activities:

    

Cash paid for financing costs

     (1,876     (80

Cash paid for contingent purchase price consideration

     (48     (13,222

Proceeds from issuance of common stock, net of issuance costs

     7,674        11,824   

Repurchase of preferred stock

     —          (49,380

Proceeds from long-term debt

     199,141        937   

Payments on long-term debt

     (16,911     (3,600

Net proceeds under revolving credit facilities

     1,339        133   

Payments on short-term debt

     (6,240     —     

Repurchase of common stock

     —          (618

Cash paid for dividends

     (5,323     —     

Excess tax benefits on exercised stock options

     148        1,169   

Principal payments on capital lease obligations

     (1,720     (653

Other

     —          (244
  

 

 

   

 

 

 

Net cash provided by (used in) financing activities

     176,184        (53,734
  

 

 

   

 

 

 

Foreign exchange effect on cash and cash equivalents

     864        1,200   
  

 

 

   

 

 

 

Net increase (decrease) in cash and cash equivalents

     214,924        (82,640

Cash and cash equivalents, beginning of period

     299,173        401,306   
  

 

 

   

 

 

 

Cash and cash equivalents, end of period

   $ 514,097      $ 318,666   
  

 

 

   

 

 

 

The accompanying notes are an integral part of these consolidated financial statements.

 

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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 statement. 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, comprehensive income and cash flows. Our audited consolidated financial statements for the year ended December 31, 2011 included information and footnotes necessary for such presentation and were included in our Annual Report on Form 10-K filed with the Securities and Exchange Commission, or SEC, on February 29, 2012. 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, 2011.

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.

Certain amounts presented may not recalculate directly, due to rounding.

(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 March 31, 2012, 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):

 

     March 31, 2012      December 31, 2011  

Raw materials

   $ 97,263       $ 92,844   

Work-in-process

     68,847         72,939   

Finished goods

     143,811         154,486   
  

 

 

    

 

 

 
   $ 309,921       $ 320,269   
  

 

 

    

 

 

 

(4) Stock-based Compensation

We recorded stock-based compensation expense in our consolidated statements of operations for the three months ended March 31, 2012 and 2011, respectively, as follows (in thousands):

 

     Three Months Ended
March 31,
 
     2012     2011  

Cost of net revenue

   $ 269      $ 350   

Research and development

     771        945   

Sales and marketing

     917        959   

General and administrative

     1,917        3,554   
  

 

 

   

 

 

 
     3,874        5,808   

Benefit for income taxes

     (541     (1,286
  

 

 

   

 

 

 
   $ 3,333      $ 4,522   
  

 

 

   

 

 

 

 

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Table of Contents

(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 March 31,  
     2012     2011  

Numerator:

    

Net income

   $ 1,029      $ 277   

Preferred stock dividends

     (5,309     (5,809

Preferred stock repurchase

     —          13,688   

Less: Net income (loss) attributable to non-controlling interest

     (185     62   
  

 

 

   

 

 

 

Net income (loss) available to common stockholders

   $ (4,095   $ 8,094   
  

 

 

   

 

 

 

Denominator:

    

Weighted-average common shares outstanding — basic

     80,240        85,362   

Effect of dilutive securities:

    

Stock options

     —          1,348   

Warrants

     —          136   

Potentially issuable shares of common stock associated with contingent consideration arrangements

     —          107   
  

 

 

   

 

 

 

Weighted-average common shares outstanding — diluted

     80,240        86,953   
  

 

 

   

 

 

 

Basic net income (loss) per common share attributable to Alere Inc. and Subsidiaries

   $ (0.05   $ 0.09   
  

 

 

   

 

 

 

Diluted net income (loss) per common share attributable to Alere Inc. and Subsidiaries

   $ (0.05   $ 0.09   
  

 

 

   

 

 

 

For the three months ended March 31, 2012 and 2011, anti-dilutive shares of 13,966 and 14,877, respectively, were excluded from the computations of diluted net income (loss) per common share.

(6) Preferred Stock

For the three months ended March 31, 2012 and 2011, Series B preferred stock dividends amounted to $5.3 million and $5.8 million, respectively, which reduced earnings available to common stockholders for purposes of calculating net income (loss) per common share for each of the respective periods. As of April 16, 2012, payments have been made covering all dividend periods through March 31, 2012.

The Series B preferred stock dividends for the three months ended March 31, 2012 were paid in cash. The Series B preferred stock dividends for the three months ended March 31, 2011 were paid in additional shares of Series B preferred stock.

During the first quarter of 2011, we repurchased in the open market and privately-negotiated transactions 183,000 shares of our Series B preferred stock, which were convertible into approximately 1.1 million shares of our common stock, at a cost of approximately $49.4 million, which we paid in cash. The repurchase of the preferred stock at an average cost of $269.84 per preferred share, an amount less than the weighted average fair value of the preferred shares at issuance, resulted in the allocation of $13.7 million of income attributable to common shareholders.

(7) Stockholders’ Equity and Non-controlling Interests

A summary of the changes in stockholders’ equity and non-controlling interests comprising total equity for the three months ended March 31, 2012 and 2011 is provided below (in thousands):

 

    Three Months Ended March 31,  
    2012     2011  
    Total
Stockholders’
Equity
    Non-
controlling
Interests
    Total
Equity
    Total
Stockholders’
Equity
    Non-
controlling
Interests
    Total
Equity
 

Equity, beginning of period

  $ 2,229,234      $ 2,340      $ 2,231,574      $ 2,575,038      $ 2,688      $ 2,577,726   

Issuance of common stock and warrants in connection with acquisitions

    —          —          —          1,000        —          1,000   

Exercise of common stock options, warrants and shares issued under employee stock purchase plan

    7,674        —          7,674        11,824        —          11,824   

Repurchase of common stock

    —          —          —          (618     —          (618

Repurchase of preferred stock

    —          —          —          (49,380     —          (49,380

Preferred stock dividends

    (5,323     —          (5,323     (33     —          (33

Stock-based compensation related to grants of common stock options

    3,874        —          3,874        5,808        —          5,808   

Excess tax benefits on exercised stock options

    104        —          104        1,169        —          1,169   

Net income (loss)

    1,214        (137     1,077        215        62        277   

Total other comprehensive income

    37,353        —          37,353        22,260        —          22,260   
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Equity, end of period

  $ 2,274,130      $ 2,203      $ 2,276,333      $ 2,567,283      $ 2,750      $ 2,570,033   
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

 

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A summary of the changes in redeemable non-controlling interest recorded in the mezzanine section of the balance sheet for the three months ended March 31, 2012 is provided below. There was no redeemable non-controlling interest during the three months ended March 31, 2011 (in thousands):

 

     Three Months Ended
March  31, 2012
 

Redeemable non-controlling interest, beginning of period

   $ 2,497   

Net loss

     (49
  

 

 

 

Redeemable non-controlling interest, end of period

   $ 2,448   
  

 

 

 

(8) Business Combinations

Acquisitions are accounted for using the acquisition method and the acquired companies’ results have been included in the accompanying consolidated financial statements from their respective dates of acquisition. During the three months ended March 31, 2012 and 2011, we expensed acquisition-related costs of $1.5 million and $1.9 million, respectively, in general and administrative expense.

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 by 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.

Net assets acquired are recorded at their fair value and are subject to adjustment upon finalization of the fair value analysis. We are not aware of any information that indicates the final fair value analysis 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 based on patterns on which the respective economic benefits are expected to be realized.

(a) Acquisitions in 2012

During the three months ended March 31, 2012, we acquired the following businesses for a preliminary aggregate purchase price of $32.8 million, which included cash payments totaling $31.8 million and a contingent consideration obligation with an aggregate acquisition date fair value of $1.0 million.

 

   

Reatrol Comercializacao De Produtos De Saude, LDA, subsequently renamed Alere Lda, located in Vila Nova de Gaia, Portugal, a distributor of products for drugs of abuse testing (Acquired January 2012)

 

   

Kullgren Holding AB, or Kullgren, located in Gensta, Sweden, a company that manufactures and distributes high quality intimacy and pharmaceutical products (Acquired February 2012)

 

   

Wellogic ME FZ-LLC, or Wellogic UAE, located in Dubai, United Arab Emirates, a company that provides development services to Alere Wellogic, LLC, which acquired the assets of Method Factory, Inc. (d/b/a Wellogic), or Wellogic, in December 2011 (Acquired February 2012)

 

   

certain assets, primarily including customer and patient lists, of AmMed Direct LLC, or AmMed, located near Nashville, Tennessee, a privately-owned mail-order provider of home-diabetes testing products and supplies (Acquired March 2012)

The operating results of Alere Lda and AmMed are included in our professional diagnostics reporting unit and business segment. The operating results of Wellogic UAE are included in our health management reporting unit and business segment. The operating results of Kullgren are included in our consumer diagnostics reporting unit and business segment.

Our consolidated statement of operations for the three months ended March 31, 2012 included revenue totaling approximately $1.4 million related to these businesses. Goodwill has been recognized in all of the acquisitions and amounted to approximately $10.2 million. Goodwill related to the acquisition of AmMed, which totaled $7.5 million, is deductible for tax purposes. The goodwill related to the remaining 2012 acquisitions is not expected to be deductible for tax purposes.

 

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A summary of the preliminary fair values of the net assets acquired for the acquisitions consummated in 2012 is as follows (in thousands):

 

Current assets (1)

   $ 2,112   

Property, plant and equipment

     1,610   

Goodwill

     10,185   

Intangible assets

     26,862   
  

 

 

 

Total assets acquired

     40,769   
  

 

 

 

Current liabilities

     1,671   

Non-current liabilities

     6,330   
  

 

 

 

Total liabilities assumed

     8,001   
  

 

 

 

Net assets acquired

     32,768   

Less:

  

Contingent consideration

     1,000   
  

 

 

 

Cash paid

   $ 31,768   
  

 

 

 

 

(1) Includes cash acquired of approximately $0.5 million.

The following are the intangible assets acquired and their respective fair values and weighted-average useful lives (dollars in thousands):

 

     Amount      Weighted-
Average
Useful Life
 

Core technology and patents

   $ 8,403         21.0 years   

Trademarks and trade names

     530         2.0 years   

Customer relationships

     17,929         7.6 years   
  

 

 

    

Total intangible assets

   $ 26,862      
  

 

 

    

(b) Acquisitions in 2011

During 2011, we acquired the following businesses for a preliminary aggregate purchase price of $787.3 million, which included cash payments totaling $603.7 million, 831,915 shares of our common stock with an acquisition date fair value of $16.2 million, a previously-held investment with a fair value totaling $113.2 million, contingent consideration obligations with an aggregate acquisition date fair value of $48.7 million and deferred purchase price consideration with an acquisition date fair value of $4.2 million.

 

   

90% interest in BioNote, Inc., or BioNote, headquartered in South Korea, a manufacturer of diagnostic products for the veterinary industry (Acquired January 2011). We previously owned a 10% interest in BioNote.

 

   

assets, including domain name, of Pregnancy.org, LLC, or Pregnancy.org, a U.S.-based company providing a website for preconception, pregnancy and newborn care content, tools and sharing (Acquired January 2011)

 

   

Home Telehealth Limited, subsequently renamed Alere Connected Health Limited, or Alere Connected Health, located in Cardiff, Wales, a company that focuses on delivering integrated, comprehensive services and programs to health and social care providers and insurers (Acquired February 2011)

 

   

Bioeasy Diagnostica Ltda., or Bioeasy, located in Belo Horizonte, Brazil, a company that markets and sells rapid diagnostic tests and systems for laboratory diagnosis, prevention and monitoring of immunological diseases and fertility (Acquired March 2011)

 

   

80.92% interest in Standing Stone, Inc., or Standing Stone, located in Westport, Connecticut, a company that focuses on disease state management by enhancing the quality of care provided to patients who require long-term therapy for chronic disease management (Acquired May 2011)

 

   

certain assets, rights, liabilities and properties of Drug Detection Devices, Inc., or 3DL, located in Alpharetta, Georgia, a distributor that promotes, markets, distributes and sells drugs of abuse diagnostic products, including consumables, point-of-care diagnostic kits and related products and services (Acquired July 2011)

 

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Colibri Medical AB, or Colibri, located in Helsingborg, Sweden, a distributor of point-of-care drugs of abuse diagnostic products primarily to the Scandinavian marketplace (Acquired July 2011)

 

   

Laboratory Data Systems, Inc., or LDS, located in Tampa, Florida, a provider of healthcare software products, services, consulting and solutions (Acquired August 2011)

 

   

certain assets, liabilities and properties of Abatek Medical LLC, or Abatek, located in Dover, New Hampshire, a distributor that promotes, markets, distributes and sells drugs of abuse diagnostic products, including consumables, point-of-care diagnostic kits and related products and services (Acquired September 2011)

 

   

Forensics Limited, or ROAR, located in Worcestershire, United Kingdom, a company that provides forensic quality toxicology services across the United Kingdom (Acquired September 2011)

 

   

Mahsan Diagnostika Vertriebsgesellschaft mbH, or Mahsan, located in Reinbek, Germany, a distributor of in vitro diagnostic drugs of abuse products primarily to the German marketplace (Acquired October 2011)

 

   

Avee Laboratories Inc. and related companies, which we refer to collectively as Avee, located in Tampa, Florida, a privately-owned provider of drug testing services in the field of pain management (Acquired October 2011)

 

   

Medical Automation Systems Inc., or MAS, located in Charlottesville, Virginia, a provider of network-based software solutions for point-of-care testing (Acquired October 2011)

 

   

Axis-Shield plc, or Axis-Shield, located in Dundee, Scotland, a U.K. publicly traded company focused on the development and manufacture of in vitro diagnostic tests for use in clinical laboratories and at the point of care (Acquired November 2011)

 

   

certain assets and properties of 1 Medical Distribution, Inc., or 1 Medical, located in Worthington, Ohio, a distributor that promotes, markets, distributes and sells drugs of abuse diagnostic products, including consumables, point-of-care diagnostic kits and related products and services (Acquired November 2011)

 

   

Arriva Medical LLC, or Arriva, located in Coral Springs, Florida, a privately-owned mail-order provider of home-diabetes testing products and supplies (Acquired November 2011)

 

   

Wellogic, headquartered in Waltham, Massachusetts, a provider of software solutions designed to connect the healthcare community (Acquired December 2011)

The operating results of BioNote, Bioeasy, 3DL, Colibri, LDS, Abatek, ROAR, Mahsan, Avee, MAS, Axis-Shield, 1 Medical and Arriva are included in our professional diagnostics reporting unit and business segment. The operating results of Pregnancy.org, Alere Connected Health, Standing Stone and Wellogic are included in our health management reporting unit and business segment.

Our consolidated statement of operations for the three months ended March 31, 2011 included revenue totaling approximately $3.0 million related to these businesses. Goodwill has been recognized in all of the acquisitions, with the exception of 1 Medical, and amounted to approximately $358.1 million. Goodwill related to the acquisitions of Pregnancy.org, 3DL, Abatek, LDS and Wellogic, which totaled $32.3 million, is expected to be deductible for tax purposes. The goodwill related to the remaining 2011 acquisitions is not expected to be deductible for tax purposes.

A summary of the preliminary fair values of the net assets acquired for the acquisitions consummated in 2011 is as follows (in thousands):

 

Current assets (1)

   $ 135,635   

Property, plant and equipment

     68,473   

Goodwill

     358,106   

Intangible assets

     416,624   

Other non-current assets

     27,679   
  

 

 

 

Total assets acquired

     1,006,517   
  

 

 

 

Current liabilities

     89,208   

Non-current liabilities

     129,962   
  

 

 

 

Total liabilities assumed

     219,170   
  

 

 

 

Net assets acquired

     787,347   

Less:

  

Fair value of previously-held equity investment

     113,168   

Contingent consideration

     48,685   

Fair value of common stock issued

     16,183   

Loan forgiveness

     1,489   

Deferred purchase price consideration

     4,170   
  

 

 

 

Cash paid

   $ 603,652   
  

 

 

 

 

(1) Includes cash acquired of approximately $23.2 million.

 

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The following are the intangible assets acquired and their respective fair values and weighted-average useful lives (dollars in thousands):

 

     Amount      Weighted-
Average
Useful Life
 

Core technology and patents

   $ 76,659         10.1 years   

Database

     64         3.0 years   

Trademarks and trade names

     14,197         10.1 years   

Customer relationships

     243,725         12.3 years   

Non-compete agreements

     8,306         5.3 years   

Software

     7,400         10.9 years   

Other

     7,767         15.6 years   

In-process research and development

     58,506         N/A   
  

 

 

    

Total intangible assets

   $ 416,624      
  

 

 

    

(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 and the total exit costs incurred since inception of each plan (in thousands):

 

     Balance at
December 31,
2011
     Adjustments
to the
Reserve (1)
    Amounts
Paid
    Balance at
March  31,
2012
     Exit Costs
Since
Inception
 

Acquisition of Matria Healthcare Inc.:

            

Severance-related costs

   $ 68       $ —        $ —        $ 68       $ 13,664   

Facility costs

     395         (111     (36     248         4,674   
  

 

 

    

 

 

   

 

 

   

 

 

    

 

 

 

Total costs for Matria Healthcare Inc.

     463         (111     (36     316         18,338   
  

 

 

    

 

 

   

 

 

   

 

 

    

 

 

 

Acquisition of Cholestech Corporation:

            

Severance-related costs

     —           —          —          —           5,845   

Facility costs

     1,304         —          (55     1,249         2,732   
  

 

 

    

 

 

   

 

 

   

 

 

    

 

 

 

Total costs for Cholestech Corporation

     1,304         —          (55     1,249         8,577   
  

 

 

    

 

 

   

 

 

   

 

 

    

 

 

 

Total costs for all plans

   $ 1,767       $ (111   $ (91   $ 1,565       $ 26,915   
  

 

 

    

 

 

   

 

 

   

 

 

    

 

 

 

 

(1) These adjustments resulted in a change in the aggregate purchase price and related goodwill for each related acquisition.

Of the total $1.6 million liability outstanding as of March 31, 2012, $0.5 million is included in accrued expenses and other current liabilities and $1.1 million is included in other long-term liabilities.

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.

 

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(9) Restructuring Plans

The following table sets forth aggregate restructuring charges recorded in our consolidated statements of operations for the three months ended March 31, 2012 and 2011 (in thousands):

 

     Three Months Ended
March  31,
 

Statement of Operations Caption

   2012      2011  

Cost of net revenue

   $ 964       $ 1,350   

Research and development

     624         18   

Sales and marketing

     827         1,012   

General and administrative

     3,113         3,819   
  

 

 

    

 

 

 

Total operating expenses

     5,528         6,199   

Interest expense, including amortization of original issue discounts and deferred financing costs

     60         49   

Equity earnings of unconsolidated entities, net of tax

     —           193   
  

 

 

    

 

 

 

Total charges

   $ 5,588       $ 6,441   
  

 

 

    

 

 

 

(a) 2012 Restructuring Plans

In 2012, management developed cost reduction efforts within our professional diagnostics business segment, including the integration of our businesses in Brazil. Additionally, management developed new plans to continue our efforts to reduce costs within our health management business segment. The following table summarizes the restructuring activities related to our 2012 restructuring plans for the three months ended March 31, 2012 (in thousands):

 

     Professional
Diagnostics
     Health
Management
     Total  

Severance-related costs - cash

   $ 1,973       $ 797       $ 2,770   

Inventory impairments - non-cash

     —           5         5   
  

 

 

    

 

 

    

 

 

 

Total charges

   $ 1,973       $ 802       $ 2,775   
  

 

 

    

 

 

    

 

 

 

We anticipate incurring approximately $0.5 million in additional costs under our 2012 restructuring plan related to our professional diagnostics business segment in Brazil and may develop additional plans over the remainder of 2012. As of March 31, 2012, $1.9 million in severance costs remain unpaid.

(b) 2011 Restructuring Plans

In 2011, management executed a company-wide cost reduction plan, which impacted our corporate and other business segment, as well as the health management and professional diagnostics business segments. Management also developed plans within our professional diagnostics business segment to consolidate operating activities among certain of our European and Asia Pacific subsidiaries, including transferring the manufacturing of our Panbio products from Australia to our Standard Diagnostics facility in South Korea. Additionally, within our health management business segment, management executed plans to further reduce costs and improve efficiencies, as well as cease operations at our GeneCare Medical Genetics Center, Inc., or GeneCare, facility in Chapel Hill, North Carolina, and transfer the majority of our Quality Assured Services, Inc. operation in Orlando, Florida to our facility in Livermore, California. The following table summarizes the restructuring activities related to our 2011 restructuring plans for the three months ended March 31, 2012 and 2011 and since inception (in thousands):

Professional Diagnostics

 

     Three Months Ended
March  31,
     Since  
     2012      2011      Inception  

Severance-related costs

   $ 1,965       $ 1,037       $ 14,012   

Facility and transition costs

     649         —           1,010   
  

 

 

    

 

 

    

 

 

 

Cash charges

     2,614         1,037         15,022   

Fixed asset and inventory impairments

     134         524         793   
  

 

 

    

 

 

    

 

 

 

Total charges

   $ 2,748       $ 1,561       $ 15,815   
  

 

 

    

 

 

    

 

 

 

 

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Table of Contents

Health Management

 

     Three Months Ended
March  31,
     Since  
     2012     2011      Inception  

Severance-related costs

   $ —        $ 1,247       $ 2,254   

Facility and transition costs

     (86     —           6,255   

Other exit costs

     25        —           119   
  

 

 

   

 

 

    

 

 

 

Cash charges

     (61     1,247         8,628   

Fixed asset and inventory impairments

     —          —           864   

Intangible asset impairments

     —          2,935         2,935   

Other non-cash charges

     —          —           761   
  

 

 

   

 

 

    

 

 

 

Total charges

   $ (61   $ 4,182       $ 13,188   
  

 

 

   

 

 

    

 

 

 

Corporate and Other

 

     Three Months Ended
March  31,
     Since  
     2012     2011      Inception  

Severance-related costs

   $  17      $ —         $ 1,210   
  

 

 

   

 

 

    

 

 

 

Cash charges

     17        —           1,210   

Fixed asset and inventory impairments

     —          —           3   
  

 

 

   

 

 

    

 

 

 

Total charges

   $ 17      $     —         $   1,213   
  

 

 

   

 

 

    

 

 

 

We anticipate incurring approximately $2.6 million in additional costs under these plans related to our professional diagnostics business segment, primarily related to severance and facility exit costs, and may also incur impairment charges on assets as plans are finalized. We anticipate incurring approximately $1.0 million in additional costs under these plans related to our health management business segment, primarily related to facility lease obligations through 2014. As of March 31, 2012, $4.9 million in cash charges remain unpaid.

(c) 2010 and 2008 Restructuring Plans

In 2010, management developed several plans to reduce costs and improve efficiencies within our health management and professional diagnostics business segments. In May 2008, management 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. Additionally in 2008, management developed and initiated plans to transition the businesses of Cholestech to our San Diego, California facility. The following table summarizes the restructuring activities related to these restructuring plans for the three months ended March 31, 2012 and 2011 and since inception (in thousands):

Professional Diagnostics

 

     Three Months Ended
March  31,
     Since  
     2012      2011      Inception  

Severance-related costs

   $ —         $ 35       $ 8,897   

Facility and transition costs

     74         382         8,386   

Other exit costs

     19         9         4,437   
  

 

 

    

 

 

    

 

 

 

Cash charges

     93         426         21,720   

Fixed asset and inventory impairments

     —           —           10,309   
  

 

 

    

 

 

    

 

 

 

Total charges

   $ 93       $ 426       $ 32,029   
  

 

 

    

 

 

    

 

 

 

Health Management

 

     Three Months Ended
March 31,
     Since  
     2012      2011      Inception  

Severance-related costs

   $ —         $ —         $ 4,647   

Facility and transition costs

     —           39         2,476   

Other exit costs

     16         40         304   
  

 

 

    

 

 

    

 

 

 

Cash charges

     16         79         7,427   

Fixed asset and inventory impairments

     —           —           165   
  

 

 

    

 

 

    

 

 

 

Total charges

   $ 16       $   79       $   7,592   
  

 

 

    

 

 

    

 

 

 

 

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Table of Contents

We anticipate incurring an additional $1.7 million in facility lease obligation charges related to the Cholestech plan through 2017 and do not anticipate incurring significant additional charges under the other plans. As of March 31, 2012, $1.5 million in facility related costs remain unpaid.

In addition to the restructuring charges discussed above, certain charges associated with the Bedford facility closure were borne by SPD, our 50/50 joint venture with the Procter & Gamble Company, or P&G. Of the restructuring charges recorded by SPD, 50% has been included in equity earnings of unconsolidated entities, net of tax, in our consolidated statement of operations. The following table summarizes the 50% portion of the restructuring charges borne by SPD and included in equity earnings of unconsolidated entities, net of tax, for the three months ended March 31, 2011 and since inception (in thousands):

 

     Three Months Ended
March 31, 2011
     Since
Inception
 

Severance-related costs

   $ 11       $ 5,797   

Facility and transition costs

     110         5,396   

Other exit costs

     —           283   
  

 

 

    

 

 

 

Cash charges

     121         11,476   

Fixed asset and inventory impairments

     72         4,635   
  

 

 

    

 

 

 

Total charges included in equity earnings of unconsolidated entities, net of tax

   $ 193       $ 16,111   
  

 

 

    

 

 

 

We do not anticipate incurring significant additional restructuring charges under this plan.

(e) Restructuring Reserves

The following table summarizes our restructuring reserves related to the plans described above, of which $6.2 million is included in accrued expenses and other current liabilities and $2.0 million is included in other long-term liabilities on our consolidated balance sheets (in thousands):

 

     Severance-
related
Costs
    Facility  and
Transition
Costs
    Other Exit
Costs
    Total  

Balance, December 31, 2011

   $ 3,380      $ 5,215      $ 593      $ 9,188   

Cash charges

     4,752        637        60        5,449   

Payments

     (4,355     (2,038     (72     (6,465

Currency adjustments

     54        4        —          58   
  

 

 

   

 

 

   

 

 

   

 

 

 

Balance, March 31, 2012

   $ 3,831      $ 3,818      $ 581      $ 8,230   
  

 

 

   

 

 

   

 

 

   

 

 

 

(10) Long-term Debt

We had the following long-term debt balances outstanding (in thousands):

 

     March 31, 2012     December 31, 2011  

A term loans (1)

   $ 909,375      $ 917,188   

B term loans

     920,375        922,688   

Incremental B-1 term loans

     249,375        250,000   

Incremental B-2 term loans

     198,004        —     

3% Senior subordinated convertible notes

     150,000        150,000   

9% Senior subordinated notes

     391,643        391,233   

7.875% Senior notes

     245,849        245,621   

8.625% Senior subordinated notes

     400,000        400,000   

Lines-of-credit

     19,271        19,603   

Other

     32,623        32,210   
  

 

 

   

 

 

 
     3,516,515        3,328,543   

Less: Current portion

     (62,932     (61,092
  

 

 

   

 

 

 
   $ 3,453,583      $ 3,267,451   
  

 

 

   

 

 

 

 

(1) Includes “A” term loans and “Delayed-Draw” term loans under our secured credit facility.

 

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In connection with our significant long-term debt issuances, we recorded interest expense, including amortization and write-offs of deferred financing costs and original issue discounts, in our consolidated statements of operations for the three months ended March 31, 2012 and 2011, respectively, as follows (in thousands):

 

     Three Months Ended March 31,  
     2012      2011  

Secured credit facility (1)

   $ 22,851       $ —     

Former secured credit facility (2)

     —           12,054   

3% Senior subordinated convertible notes

     1,246         1,246   

9% Senior subordinated notes

     10,354         9,730   

7.875% Senior notes

     5,758         5,365   

8.625% Senior subordinated notes

     9,274         8,908   
  

 

 

    

 

 

 
   $ 49,483       $ 37,303   
  

 

 

    

 

 

 

 

(1) Includes “A” term loans, including the “Delayed-Draw” term loans; “B” term loans; “Incremental B-1” term loans; “Incremental B-2” term loans; and revolving line of credit loans. For three months ended March 31, 2012, amount includes $1.3 million related to the amortization of fees paid for certain debt modifications.

 

(2) Includes loans under First Lien Credit Agreement and Second Lien Credit Agreement.

The following summarizes the material terms of our secured credit facility that have changed significantly since December 31, 2011. All other terms of our secured credit facility as described in our Annual Report on Form 10-K for the year ended December 31, 2011, but omitted below, have not changed since that date.

On March 28, 2012, we and certain of our subsidiaries entered into a third amendment to the credit agreement that governs our secured credit facility, or the credit agreement. The third amendment provides for an additional term loan facility consisting of “Incremental B-2” term loans in the aggregate principal amount of $200.0 million and thereby increases the total amount of the credit available to us under the secured credit facility to $2.55 billion in aggregate principal amount, consisting of term loans in the aggregate principal amount of $2.3 billion and, subject to our continued compliance with the credit agreement, a $250.0 million revolving line of credit; the revolving line of credit continues to include a sublimit for the issuance of letters of credit. On March 28, 2012, we borrowed the entire $200.0 million principal amount of the “Incremental B-2” term loans.

Under the terms of the third amendment, we must repay the principal amount of the “Incremental B-2” term loans in twenty consecutive quarterly installments, beginning on June 30, 2012 and continuing through March 31, 2017, in the amount of $0.5 million each, and a final installment on June 30, 2017 in the amount of $190.0 million; notwithstanding the foregoing, and subject to certain exceptions provided for in the credit agreement, in the event that any of our existing 3% senior subordinated convertible notes, 9% senior subordinated notes or 7.875% senior notes remain outstanding on the date that is six months prior to the relevant maturity date thereof, respectively, then the “Incremental B-2” term loans (as well as all other term loans and all revolving credit loans under the secured credit facility) shall instead mature in full on the relevant prior date. Otherwise, the terms and conditions, including the interest rates, that apply to the “Incremental B-2” term loans under the credit agreement are substantially the same as the terms and conditions, including the interest rates, that apply to the existing “B” term loans under the credit agreement.

(11) Derivative Financial Instruments

We manage our economic and transaction exposure to certain market-based risks through the use of derivative instruments. Our objective for holding derivative instruments has been to reduce volatility of net earnings and cash flows associated with changes in interest rates and foreign currency exchange rates. We do not hold or issue derivative financial instruments for speculative purposes.

(a) Interest Rate Risk

We used interest rate swap contracts in the management of our interest rate exposure related to our former secured credit facility. On June 30, 2011, we entered into a new secured credit facility and, in connection therewith, repaid in full all outstanding indebtedness under and terminated our former secured credit facility and related interest rate swaps.

(b) Foreign Currency Risk

In connection with our acquisition of Axis-Shield, we acquired a number of foreign currency forward contracts. The specific risk hedged in these contracts is the undiscounted foreign currency spot rate risk on forecasted foreign currency revenue. As of March 31, 2012 and December 31, 2011, the notional value of these contracts was approximately $3.5 million and CHF 3.2 million and $16.6 million and CHF 5.4 million, respectively. We report the effective portion of the gain or loss on a cash flow hedge as a component of other comprehensive income, and it is subsequently reclassified into net earnings in the period in which the hedged transaction affects net earnings or the forecasted transaction is no longer probable of occurring.

 

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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 (in thousands):

 

Derivative Instruments

  

Balance Sheet Caption

     Fair Value at    
March 31,

2012
     Fair Value at
    December 31,  
2011
 

Foreign currency forward contracts

  

Prepaid expenses and other current assets

   $ 641       $ —     
     

 

 

    

 

 

 

Foreign currency forward contracts

  

Accrued expenses and other current liabilities

   $ —         $ 447   
     

 

 

    

 

 

 

 

Derivative Instruments

  

Location of Gain

Recognized in Income

   Amount of Gain
Recognized
During the Three
Months Ended
March 31, 2012
     Amount of Gain
Recognized
During the Three
Months Ended
March 31, 2011
 

Foreign currency forward contracts

  

Other comprehensive income

   $ 1,107       $ —     

Interest rate swap contracts

  

Other comprehensive income

     —           1,617   
     

 

 

    

 

 

 

Total gain

  

Other comprehensive income

   $ 1,107       $ 1,617   
     

 

 

    

 

 

 

(12) 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 assets and liabilities include foreign exchange forward contracts and 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 is 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 March 31, 2012 and December 31, 2011, and indicates the fair value hierarchy of the valuation techniques we utilized to determine such fair value (in thousands):

 

Description

     March 31,    
2012
     Quoted Prices in
Active Markets
(Level 1)
     Significant Other
Observable Inputs
(Level 2)
     Unobservable Inputs
(Level 3)
 

Assets:

           

Marketable securities

   $ 3,776       $ 3,776       $ —         $ —     

Foreign exchange forward contracts (1)

     641         —           641         —     
  

 

 

    

 

 

    

 

 

    

 

 

 

Total assets

   $ 4,417       $ 3,776       $ 641       $ —     
  

 

 

    

 

 

    

 

 

    

 

 

 

Liabilities:

           

Contingent consideration obligations (2)

   $ 146,301       $ —         $ —         $ 146,301   
  

 

 

    

 

 

    

 

 

    

 

 

 

Total liabilities

   $ 146,301       $ —         $ —         $ 146,301   
  

 

 

    

 

 

    

 

 

    

 

 

 

 

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Description

   December 31,
2011
     Quoted Prices in
Active Markets
(Level 1)
     Significant Other
Observable Inputs
(Level 2)
     Unobservable Inputs
(Level 3)
 

Assets:

           

Marketable securities

   $ 3,340       $ 3,340       $ —         $ —     
  

 

 

    

 

 

    

 

 

    

 

 

 

Total assets

   $ 3,340       $ 3,340       $ —         $ —     
  

 

 

    

 

 

    

 

 

    

 

 

 

Liabilities:

Foreign exchange forward contracts (1)

   $ 447       $ —         $ 447       $ —     

Contingent consideration obligations (2)

     140,047         —           —           140,047   
  

 

 

    

 

 

    

 

 

    

 

 

 

Total liabilities

   $ 140,494       $ —         $ 447       $ 140,047   
  

 

 

    

 

 

    

 

 

    

 

 

 

 

(1) The fair value of the foreign exchange forward contracts was measured using readily observable market inputs, such as quotations on forward foreign exchange points and foreign interest rates.

 

(2) The fair value measurements for our contingent consideration obligations relate to acquisitions completed after January 1, 2009 and 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 fair value of these contingent consideration obligations are recorded as income or expense within operating income in our consolidated statements of operations.

Changes in the fair value of our Level 3 contingent consideration obligations during the three months ended March 31, 2012 were as follows (in thousands):

 

Fair value of contingent consideration obligations, January 1, 2012

   $ 140,047   

Acquisition date fair value of contingent consideration obligations recorded

     1,000   

Foreign currency

     277   

Payments

     (67

Present value accretion

     3,457   

Adjustments, net (income) expense

     1,587   
  

 

 

 

Fair value of contingent consideration obligations, March 31, 2012

   $ 146,301   
  

 

 

 

At March 31, 2012 and December 31, 2011, 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 estimated fair value of our long-term debt were $3.5 billion at March 31, 2012. The carrying amount and estimated fair value of our long-term debt were $3.3 billion at December 31, 2011. The estimated fair value of our long-term debt was determined using market sources that were derived from available market information (Level 2 in the fair value hierarchy) and may not be representative of actual values that could have been or will be realized in the future.

(13) Defined Benefit Pension Plan

Our subsidiary in England, Unipath Ltd., has a defined benefit pension plan established for certain of its employees. The net periodic benefit costs are as follows (in thousands):

 

     Three Months Ended March 31,  
     2012     2011  

Service cost

   $ —        $ —     

Interest cost

     198        202   

Expected return on plan assets

     (152     (155

Amortization of prior service cost

     104        106   

Realized losses

     —          —     
  

 

 

   

 

 

 

Net periodic benefit cost

   $ 150      $ 153   
  

 

 

   

 

 

 

 

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(14) 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 are allocated to Professional Diagnostics and Consumer Diagnostics on the basis of the original license or royalty agreement.

We evaluate performance of our operating segments based on revenue and operating income (loss). Segment information for the three months ended March 31, 2012 and 2011 is as follows (in thousands):

 

     Professional
Diagnostics
     Health
Management
    Consumer
Diagnostics
     Corporate
and
Other
    Total  

Three Months Ended March 31, 2012:

            

Net revenue

   $ 518,357       $ 130,784      $ 21,988       $ —        $ 671,129   

Operating income (loss)

   $ 70,179       $ (19,356   $ 365       $ (16,130   $ 35,058   

Depreciation and amortization

   $ 82,148       $ 23,774      $ 1,259       $ 221      $ 107,402   

Restructuring charge

   $ 4,794       $ 717      $ —         $ 17      $ 5,528   

Stock-based compensation

   $ —         $ —        $ —         $ 3,874      $ 3,874   

Three Months Ended March 31, 2011:

            

Net revenue

   $ 415,812       $ 143,063      $ 23,589       $ —        $ 582,464   

Operating income (loss)

   $ 60,262       $ (11,933   $ 3,361       $ (20,785   $ 30,905   

Depreciation and amortization

   $ 65,249       $ 28,314      $ 1,259       $ 153      $ 94,975   

Restructuring charge

   $ 1,978       $ 4,221      $ —         $ —        $ 6,199   

Stock-based compensation

   $ —         $ —        $ —         $ 5,808      $ 5,808   

Assets:

            

As of March 31, 2012

   $ 5,835,623       $ 613,419      $ 188,454       $ 251,785      $ 6,889,281   

As of December 31, 2011

   $ 5,826,756       $ 624,305      $ 199,422       $ 22,218      $ 6,672,701   

The following tables summarize our net revenue from the professional diagnostics and health management reporting segments by groups of similar products and services for the three months ended March 31, 2012 and 2011 (in thousands):

Professional Diagnostics Segment

 

     Three Months Ended
March 31,
 
     2012      2011  

Cardiology

   $ 138,826       $ 129,855   

Infectious disease

     151,016         140,426   

Toxicology

     121,740         85,504   

Diabetes

     28,161         —     

Other

     75,706         54,000   
  

 

 

    

 

 

 

Net product sales and services revenue

     515,449         409,785   

License and royalty revenue

     2,908         6,027   
  

 

 

    

 

 

 

Professional diagnostics net revenue

   $ 518,357       $ 415,812   
  

 

 

    

 

 

 

Health Management Segment

 

     Three Months Ended
March 31,
 
     2012      2011  

Disease and case management

   $ 53,380       $ 61,455   

Wellness

     27,026         29,805   

Women’s & children’s health

     29,771         28,575   

Patient self-testing services

     20,607         23,228   
  

 

 

    

 

 

 

Health management net revenue

   $ 130,784       $ 143,063   
  

 

 

    

 

 

 

(15) 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,

 

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diabetes and oral care fields. Upon completion of the arrangement to form the joint venture, we ceased to consolidate the operating results of our consumer diagnostic products business related to the joint venture and instead account for our 50% interest in the results of the joint venture under the equity method of accounting.

We had a net receivable from the joint venture of $2.1 million and $2.5 million as of March 31, 2012 and December 31, 2011, respectively. Included in the $2.1 million receivable balance as of March 31, 2012 is approximately $1.6 million of costs incurred in connection with our 2008 SPD-related restructuring plans. Included in the $2.5 million receivable balance as of December 31, 2011 is approximately $1.5 million of costs incurred in connection with our 2008 SPD-related restructuring plans. We have also recorded a long-term receivable totaling approximately $16.0 million and $15.5 million as of March 31, 2012 and December 31, 2011, respectively, related to the 2008 SPD-related restructuring plans. Additionally, customer receivables associated with revenue earned after the joint venture was completed have been classified as other receivables within prepaid and other current assets on our accompanying consolidated balance sheets in the amount of $10.7 million and $7.3 million as of March 31, 2012 and December 31, 2011, respectively. In connection with the joint venture arrangement, the joint venture bears the collection risk associated with these receivables. Sales to the joint venture under our manufacturing agreement totaled $17.1 million and $16.3 million during the three months ended March 31, 2012 and 2011, respectively. Additionally, services revenue generated pursuant to the long-term services agreement with the joint venture totaled $0.3 million during each of the three-month periods ended March 31, 2012 and 2011. 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, the joint venture purchases products from our manufacturing facilities in the U.K. and China. The joint venture 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 $6.7 million and $8.9 million of trade receivables which are included in accounts receivable on our accompanying consolidated balance sheets as of March 31, 2012 and December 31, 2011, respectively, and $19.1 million and $19.3 million of trade accounts payable which are included in accounts payable on our accompanying consolidated balance sheets as of March 31, 2012 and December 31, 2011, respectively. During the three months ended March 31, 2012, we received $6.1 million in cash from SPD as a return of capital.

(16) Material Contingencies and Legal Settlements

(a) Legal Proceedings

We are not a party to any pending legal proceedings that we currently believe could have a material adverse impact on our sales, operations or financial performance. However, because of the nature of our business, we may be subject at any particular time to lawsuits or other claims arising in the ordinary course of our business, and we expect that this will continue to be the case in the future.

(b) Acquisition-related Contingent Consideration Obligations

The following summarizes our principal contractual acquisition-related contingent consideration obligations as of March 31, 2012 that have changed significantly since December 31, 2011. Other acquisition-related contingent consideration obligations that were presented in our Annual Report on Form 10-K for the year ended December 31, 2011, but omitted below, represent those that have not changed significantly since that date.

 

   

AmMed

With respect to AmMed, the terms of the acquisition agreement require us to pay an earn-out upon successfully meeting certain operational targets within six months of the acquisition date. The maximum amount of the earn-out payment is $2.0 million.

(c) FDA Inspection and Office of Inspector General Subpoena

        In March 2012, the Food & Drug Administration, or FDA, began an inspection of our San Diego facility related to our Alere Triage products. During the inspection, the FDA expressed concern about the alignment between certain aspects of our labeling for the Alere Triage products and the quality control release method that had been in effect prior to the inspection. To our knowledge, the FDA has not yet closed the inspection and has not issued any inspectional observations on Form 483. We are continuing to engage in discussions with the FDA regarding the Alere Triage products and have adopted an interim revised release method which we have been shipping against since early April 2012, with plans to further tighten the release method by September 30, 2012. Although the discussions with the FDA are ongoing, we expect that resolution of the issues raised by the FDA will involve a recall of unexpired lots of Alere Triage products that do not satisfy the revised quality control release method set through such resolution. Based on customer order patterns, expected customer inventory levels and the passage of time between March 31, 2012 and the date of any potential recall, we do not believe that the quantity or value of products that were sold on or before March 31, 2012 that may ultimately be returned will be material and, accordingly, we do not believe that any such recall will have a material impact on our results of operations for the quarter ended March 31, 2012. However, because the quality control release methods that we will apply in the future have not been determined, at this time we are unable to determine the scope of any anticipated recall, including the type and number of products that may be returned. Similarly, we are unable to determine the impact on our ability to ship existing inventory of, and to continue to manufacture, Alere Triage products that satisfy such release methods. Consequently, we are also unable to determine whether the anticipated recall or the revised release methods will have a material impact on our revenues, results of operations, earnings, cash flows or financial condition.

Also, in May 2012, we received a subpoena from the Office of Inspector General of the Department of Health and Human Services. The subpoena seeks documents relating primarily to the quality control testing and performance characteristics of Alere Triage products. We are cooperating with the government and are in the process of responding to the subpoena.

We are unable to predict when these matters will be resolved, what action, if any, the government will take in connection with these matters or what impact, if any, these matters or ensuing proceedings, if any, will have on our financial condition, results of operations or cash flows.

(17) Recent Accounting Pronouncements

From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board, or FASB, or other standard setting bodies that we adopt as of the specified effective date. Unless otherwise discussed, we believe that the impact of recently issued standards that are not yet effective will not have a material impact on our financial position, results of operations, comprehensive income or cash flows upon adoption.

 

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Recently Adopted Standards

Effective January 1, 2012, we adopted Accounting Standards Update, or ASU, No. 2011-08, Intangibles — Goodwill and Other (Topic 350): Testing for Goodwill Impairment, or ASU 2011-08. ASU 2011-08 allows an entity the option to first assess qualitative factors to determine whether it is necessary to perform the current two-step impairment test. If an entity believes, as a result of its qualitative assessment, that it is more-likely-than-not that the fair value of a reporting unit is less than its carrying amount, the quantitative two-step impairment test is required; otherwise, no further testing is required. This update does not change the current guidance for testing other indefinite-lived intangible assets for impairment. The adoption of this standard did not have an impact on our financial position, results of operations, comprehensive income or cash flows.

Effective January 1, 2012, we adopted ASU No. 2011-05, Comprehensive Income (Topic 220): Presentation of Comprehensive Income, or ASU 2011-05. ASU 2011-05 (1) eliminates the option to present the components of other comprehensive income as part of the statement of changes in stockholders’ equity; (2) requires the consecutive presentation of the statement of net income and other comprehensive income; and (3) requires an entity to present reclassification adjustments on the face of the financial statements from other comprehensive income to net income. This update does not change the items that must be reported in other comprehensive income or when an item of other comprehensive income must be reclassified to net income nor do the amendments affect how earnings per share is calculated or presented. Effective January 1, 2012, the FASB issued ASU No. 2011-12, Comprehensive Income (Topic 220): Deferral of the Effective Date for Amendments to the Presentation of Reclassifications of Items Out of Accumulated Other Comprehensive Income in Accounting Standards Update No. 2011-05, or ASU 2011-12. As these accounting standards only require enhanced disclosure, the adoption of these standards did not impact our financial position, results of operations, comprehensive income or cash flows.

Effective January 1, 2012, we adopted ASU No. 2011-04, Fair Value Measurements (Topic 820): Amendments to Achieve Common Fair Value Measurement and Disclosure Requirements in U.S. GAAP and IFRS, or ASU 2011-04. ASU 2011-04 provides common requirements for measuring fair value and disclosing information about fair value measurements in accordance with U.S. GAAP and International Financial Reporting Standards.

(18) 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:

(a) 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. For the three months ended March 31, 2012 and 2011, we recorded earnings of $2.8 million and $0.4 million, 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.

(b) 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. For the three months ended March 31, 2012 and 2011, we recorded earnings of $0.7 million and $0.5 million, 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 March 31,  
     2012      2011  

Net revenue

   $ 52,525       $ 55,554   
  

 

 

    

 

 

 

Gross profit

   $ 35,179       $ 35,465   
  

 

 

    

 

 

 

Net income after taxes

   $ 6,993       $ 1,834   
  

 

 

    

 

 

 

 

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Combined Condensed Balance Sheets:

 

     March 31, 2012      December 31, 2011  

Current assets

   $ 72,019       $ 84,376   

Non-current assets

     40,930         37,659   
  

 

 

    

 

 

 

Total assets

   $ 112,949       $ 122,035   
  

 

 

    

 

 

 

Current liabilities

   $ 42,724       $ 49,453   

Non-current liabilities

     8,155         6,326   
  

 

 

    

 

 

 

Total liabilities

   $ 50,879       $ 55,779   
  

 

 

    

 

 

 

(19) Guarantor Financial Information

Our 9% senior subordinated notes due 2016, our 7.875% senior notes due 2016, and our 8.625% senior subordinated notes due 2018 are guaranteed by certain of our consolidated wholly owned 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 March 31, 2012 and December 31, 2011, the related statements of operations, statements of comprehensive income and statements of cash flows for each of the three months ended March 31, 2012 and 2011, 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.

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.

For comparative purposes, certain amounts for prior periods have been reclassified to conform to the current period classification.

 

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CONSOLIDATING STATEMENT OF OPERATIONS

For the Three Months Ended March 31, 2012

(in thousands)

 

    Issuer     Guarantor
Subsidiaries
    Non-Guarantor
Subsidiaries
    Eliminations     Consolidated  

Net product sales

  $ —        $ 219,216      $ 289,800      $ (33,229   $ 475,787   

Services revenue

    —          146,133        46,301        —          192,434   
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Net product sales and services revenue

    —          365,349        336,101        (33,229     668,221   

License and royalty revenue

    —          4,229        2,621        (3,942     2,908   
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Net revenue

    —          369,578        338,722        (37,171     671,129   
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Cost of net product sales

    850        103,921        153,879        (33,096     225,554   

Cost of services revenue

    —          77,703        13,157        —          90,860   
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Cost of net product sales and services revenue

    850        181,624        167,036        (33,096     316,414   

Cost of license and royalty revenue

    —          —          5,586        (3,942     1,644   
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Cost of net revenue

    850        181,624        172,622        (37,038     318,058   
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Gross profit (loss)

    (850     187,954        166,100        (133     353,071   
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Operating expenses:

         

Research and development

    5,196        16,576        17,228        —          39,000   

Sales and marketing

    1,057        77,559        79,962        —          158,578   

General and administrative

    11,631        58,301        50,503        —          120,435   
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total operating expenses

    17,884        152,436        147,693        —          318,013   
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Operating income (loss)

    (18,734     35,518        18,407        (133     35,058   

Interest expense, including amortization of original issue discounts and deferred financing costs

    (49,716     (11,006     (3,315     13,310        (50,727

Other income (expense), net

    (8,074     9,428        23,787        (13,310     11,831   
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Income (loss) before provision (benefit) for income taxes

    (76,524     33,940        38,879        (133     (3,838

Provision (benefit) for income taxes

    (26,998     12,305        13,167        71        (1,455
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Income (loss) before equity earnings of unconsolidated entities, net of tax

    (49,526     21,635        25,712        (204     (2,383

Equity in earnings of subsidiaries, net of tax

    49,895        (348     —          (49,547     —     

Equity earnings of unconsolidated entities, net of tax

    660        —          2,736        16        3,412   
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Net income (loss)

    1,029        21,287        28,448        (49,735     1,029   

Less: Net income attributable to non-controlling interests

    —          —          (185     —          (185
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Net income (loss) attributable to Alere Inc. and Subsidiaries

    1,029        21,287        28,633        (49,735     1,214   

Preferred stock dividends

    (5,309     —          —          —          (5,309
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Net income (loss) available to common stockholders

  $ (4,280   $ 21,287      $ 28,633      $ (49,735   $ (4,095
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

 

23


Table of Contents

CONSOLIDATING STATEMENT OF OPERATIONS

For the Three Months Ended March 31, 2011

(in thousands)

 

     Issuer     Guarantor
Subsidiaries
    Non-Guarantor
Subsidiaries
    Eliminations     Consolidated  

Net product sales

   $ —        $ 237,976      $ 199,970      $ (30,703   $ 407,243   

Services revenue

     —          151,525        16,027        —          167,552   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Net product sales and services revenue

     —          389,501        215,997        (30,703     574,795   

License and royalty revenue

     —          2,474        6,633        (1,438     7,669   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Net revenue

     —          391,975        222,630        (32,141     582,464   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Cost of net product sales

     770        107,162        112,135        (30,380     189,687   

Cost of services revenue

     —          78,535        6,181        —          84,716   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Cost of net product sales and services revenue

     770        185,697        118,316        (30,380     274,403   

Cost of license and royalty revenue

     —          —          3,292        (1,438     1,854   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Cost of net revenue

     770        185,697        121,608        (31,818     276,257   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Gross profit (loss)

     (770     206,278        101,022        (323     306,207   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Operating expenses:

          

Research and development

     4,741        17,781        14,020        —          36,542   

Sales and marketing

     651        82,860        49,698        —          133,209   

General and administrative

     14,636        60,201        30,714        —          105,551   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total operating expenses

     20,028        160,842        94,432        —          275,302   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Operating income (loss)

     (20,798     45,436        6,590        (323     30,905   

Interest expense, including amortization of original issue discounts and deferred financing costs

     (25,606     (28,179     (4,369     19,849        (38,305

Other income (expense), net

     3,365        13,854        4,966        (19,849     2,336   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Income (loss) before provision (benefit) for income taxes

     (43,039     31,111        7,187        (323     (5,064

Provision (benefit) for income taxes

     (20,795     14,136        2,454        (125     (4,330
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Income (loss) before equity earnings of unconsolidated entities, net of tax

     (22,244     16,975        4,733        (198     (734

Equity in earnings of subsidiaries, net of tax

     22,053        —          —          (22,053     —     

Equity earnings of unconsolidated entities, net of tax

     468        —          490        53        1,011   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Net income (loss)

     277        16,975        5,223        (22,198     277   

Less: Net income attributable to non-controlling interests

     —          —          62        —          62   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Net income (loss) attributable to Alere Inc. and Subsidiaries

     277        16,975        5,161        (22,198     215   

Preferred stock dividends

     (5,809     —          —          —          (5,809

Preferred stock repurchase

     13,688        —          —          —          13,688   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Net income (loss) available to common stockholders

   $ 8,156      $ 16,975      $ 5,161      $ (22,198   $ 8,094   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

 

24


Table of Contents

CONSOLIDATING STATEMENT OF COMPREHENSIVE INCOME

For the Three Months Ended March 31, 2012

(in thousands)

 

    Issuer     Guarantor
Subsidiaries
    Non-Guarantor
Subsidiaries
    Eliminations     Consolidated  

Net income (loss)

  $ 1,029      $ 21,287      $ 28,448      $ (49,735   $ 1,029   
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Other comprehensive income, before tax:

         

Changes in cumulative translation adjustment

    328        74        34,872        665        35,939   

Unrealized gains on available for sale securities

    430        1        —          —          431   

Unrealized gains on hedging instruments

    17        —          1,090        —          1,107   

Minimum pension liability adjustment

    —          —          (165     —          (165
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Other comprehensive income, before tax

    775        75        35,797        665        37,312   

Income tax benefit related to items of other comprehensive income

    —          —          (41     —          (41
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Other comprehensive income, net of tax

    775        75        35,838        665        37,353   
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Comprehensive income (loss)

    1,804        21,362        64,286        (49,070     38,382   

Less: Comprehensive loss attributable to non-controlling interests

    —          —          (185     —          (185
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Comprehensive income (loss) attributable to Alere Inc. and Subsidiaries

  $ 1,804      $ 21,362      $ 64,471      $ (49,070   $ 38,567   
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

 

25


Table of Contents

CONSOLIDATING STATEMENT OF COMPREHENSIVE INCOME

For the Three Months Ended March 31, 2011

(in thousands)

 

    Issuer     Guarantor
Subsidiaries
    Non-Guarantor
Subsidiaries
    Eliminations     Consolidated  

Net income (loss)

  $ 277      $ 16,975      $ 5,223      $ (22,198   $ 277   
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Other comprehensive income, before tax:

         

Changes in cumulative translation adjustment

    608        137        17,237        3,533        21,515   

Unrealized gains (losses) on available for sale securities

    131        —          (346     —          (215

Unrealized gains on hedging instruments

    1,617        —          —          —          1,617   

Minimum pension liability adjustment

    —          —          (38     —          (38
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Other comprehensive income, before tax

    2,356        137        16,853        3,533        22,879   

Income tax provision (benefit) related to items of other comprehensive income

    629        —          (10     —          619   
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Other comprehensive income, net of tax

    1,727        137        16,863        3,533        22,260   
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Comprehensive income (loss)

    2,004        17,112        22,086        (18,665     22,537   

Less: Comprehensive income attributable to non-controlling interests

    —          —          62        —          62   
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Comprehensive income (loss) attributable to Alere Inc. and Subsidiaries

  $ 2,004      $ 17,112      $ 22,024      $ (18,665   $ 22,475   
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

 

26


Table of Contents

CONSOLIDATING BALANCE SHEET

March 31, 2012

(in thousands)

 

     Issuer     Guarantor
Subsidiaries
     Non-Guarantor
Subsidiaries
     Eliminations     Consolidated  

ASSETS

            

Current assets:

            

Cash and cash equivalents

   $ 243,062      $ 63,996       $ 207,039       $ —        $ 514,097   

Restricted cash

     —          1,579         1,105         —          2,684   

Marketable securities

     —          775         317         —          1,092   

Accounts receivable, net of allowances

     —          203,267         285,995         —          489,262   

Inventories, net

     —          121,403         193,936         (5,418     309,921   

Deferred tax assets

     9,907        22,797         6,192         1,894        40,790   

Receivable from joint venture, net

     —          1,894         243         —          2,137   

Prepaid expenses and other current assets

     (84,603     141,143         80,032         —          136,572   

Intercompany receivables

     392,474        411,451         78,994         (882,919     —     
  

 

 

   

 

 

    

 

 

    

 

 

   

 

 

 

Total current assets

     560,840        968,305         853,853         (886,443     1,496,555   

Property, plant and equipment, net

     2,381        273,773         230,882         (529     506,507   

Goodwill

     —          1,530,258         1,309,894         (4,981     2,835,171   

Other intangible assets with indefinite lives

     —          7,100         65,334         —          72,434   

Finite-lived intangible assets, net

     26,488        970,494         759,251         —          1,756,233   

Deferred financing costs, net and other non-current assets

     91,655        5,797         9,696         —          107,148   

Receivable from joint venture, net of current portion

     —          —           15,977         —          15,977   

Investments in subsidiaries

     3,545,610        49,159         3,000         (3,597,769     —     

Investments in unconsolidated entities

     32,459        —           52,933         —          85,392   

Marketable securities

     2,684        —           —           —          2,684   

Deferred tax assets

     —          —           11,180         —          11,180   

Intercompany notes receivable

     1,894,186        915,127         —           (2,809,313     —     
  

 

 

   

 

 

    

 

 

    

 

 

   

 

 

 

Total assets

   $ 6,156,303      $ 4,720,013       $ 3,312,000       $ (7,299,035   $ 6,889,281   
  

 

 

   

 

 

    

 

 

    

 

 

   

 

 

 
LIABILITIES AND EQUITY             

Current liabilities:

            

Current portion of long-term debt

   $ 45,000      $ 595       $ 17,337       $ —        $ 62,932   

Current portion of capital lease obligations

     —          1,409         4,387         —          5,796   

Accounts payable

     5,841        50,076         83,606         —          139,523   

Accrued expenses and other current liabilities

     (277,121     481,300         193,270         —          397,449   

Intercompany payables

     444,483        116,147         322,283         (882,913     —     
  

 

 

   

 

 

    

 

 

    

 

 

   

 

 

 

Total current liabilities

     218,203        649,527         620,883         (882,913     605,700   
  

 

 

   

 

 

    

 

 

    

 

 

   

 

 

 

Long-term liabilities:

            

Long-term debt, net of current portion

     3,429,233        —           24,350         —          3,453,583   

Capital lease obligations, net of current portion

     —          1,814         9,912         —          11,726   

Deferred tax liabilities

     (30,241     291,722         109,650         59        371,190   

Other long-term liabilities

     23,557        46,986         97,758         —          168,301   

Intercompany notes payables

     241,421        1,786,460         779,135         (2,807,016     —     
  

 

 

   

 

 

    

 

 

    

 

 

   

 

 

 

Total long-term liabilities

     3,663,970        2,126,982         1,020,805         (2,806,957     4,004,800   
  

 

 

   

 

 

    

 

 

    

 

 

   

 

 

 

Redeemable non-controlling interest

     —          —           2,448         —          2,448   
  

 

 

   

 

 

    

 

 

    

 

 

   

 

 

 

Stockholders’ equity

     2,274,130        1,943,504         1,665,661         (3,609,165     2,274,130   

Non-controlling interests

     —          —           2,203         —          2,203   
  

 

 

   

 

 

    

 

 

    

 

 

   

 

 

 

Total equity

     2,274,130        1,943,504         1,667,864         (3,609,165     2,276,333   
  

 

 

   

 

 

    

 

 

    

 

 

   

 

 

 

Total liabilities and equity

   $ 6,156,303      $ 4,720,013       $ 3,312,000       $ (7,299,035   $ 6,889,281   
  

 

 

   

 

 

    

 

 

    

 

 

   

 

 

 

 

27


Table of Contents

CONSOLIDATING BALANCE SHEET

December 31, 2011

(in thousands)

 

    Issuer     Guarantor
Subsidiaries
    Non-Guarantor
Subsidiaries
    Eliminations     Consolidated  

ASSETS

         

Current assets:

         

Cash and cash equivalents

  $ 12,451      $ 85,838      $ 200,884      $ —        $ 299,173   

Restricted cash

    —          1,591        7,396        —          8,987   

Marketable securities

    —          770        316        —          1,086   

Accounts receivable, net of allowances

    —          199,547        276,277        —          475,824   

Inventories, net

    —          136,091        189,886        (5,708     320,269   

Deferred tax assets

    10,912        22,813        7,266        1,984        42,975   

Receivable from joint venture, net

    —          2,301        202        —          2,503   

Prepaid expenses and other current assets

    (74,078     138,329        78,659        —          142,910   

Intercompany receivables

    397,914        426,136        27,871        (851,921     —     
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total current assets

    347,199        1,013,416        788,757        (855,645     1,293,727   

Property, plant and equipment, net

    2,542        274,588        214,206        (131     491,205   

Goodwill

    —          1,530,324        1,295,791        (4,844     2,821,271   

Other intangible assets with indefinite lives

    —          7,100        62,446        —          69,546   

Finite-lived intangible assets, net

    28,685        1,011,852        745,388        —          1,785,925   

Deferred financing costs, net, and other non-current assets

    88,153        5,532        4,101        —          97,786   

Receivable from joint venture, net of current portion

    —          —          15,455        —          15,455   

Investments in subsidiaries

    3,586,625        32,512        3,005        (3,622,142     —     

Investments in unconsolidated entities

    29,021        —          56,117        —          85,138   

Marketable securities

    2,254        —          —          —          2,254   

Deferred tax assets

    —          —          10,394        —          10,394   

Intercompany notes receivable

    1,934,366        (196,820     —          (1,737,546     —     
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total assets

  $ 6,018,845      $ 3,678,504      $ 3,195,660      $ (6,220,308   $ 6,672,701   
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 
LIABILITIES AND EQUITY          

Current liabilities:

         

Current portion of long-term debt

  $ 43,000      $ —        $ 18,092      $ —        $ 61,092   

Current portion of capital lease obligations

    —          1,550        4,533        —          6,083   

Short-term debt

    6,240        —          —          —          6,240   

Accounts payable

    6,704        53,978        94,782        —          155,464   

Accrued expenses and other current liabilities

    (259,010     455,366        199,217        —          395,573   

Intercompany payables

    429,644        104,257        318,018        (851,919     —     
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total current liabilities

    226,578        615,151        634,642        (851,919     624,452   
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Long-term liabilities:

         

Long-term debt, net of current portion

    3,243,341        —          24,110        —          3,267,451   

Capital lease obligations, net of current portion

    —          2,175        10,454        —          12,629   

Deferred tax liabilities

    (25,936     303,837        102,730        69        380,700   

Other long-term liabilities

    24,407        47,135        81,856        —          153,398   

Intercompany notes payables

    321,221        658,573        754,650        (1,734,444     —     
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total long-term liabilities

    3,563,033        1,011,720        973,800        (1,734,375     3,814,178   
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Redeemable non-controlling interest

    —          —          2,497        —          2,497   
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Stockholders’ equity

    2,229,234        2,051,633        1,582,381        (3,634,014     2,229,234   

Non-controlling interests

    —          —          2,340        —          2,340   
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total equity

    2,229,234        2,051,633        1,584,721        (3,634,014     2,231,574   
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total liabilities and equity

  $ 6,018,845      $ 3,678,504      $ 3,195,660      $ (6,220,308   $ 6,672,701   
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

 

28


Table of Contents

CONSOLIDATING STATEMENT OF CASH FLOWS

For the Three Months Ended March 31, 2012

(in thousands)

 

    Issuer     Guarantor
Subsidiaries
    Non-Guarantor
Subsidiaries
    Eliminations     Consolidated  

Cash Flows from Operating Activities:

         

Net income (loss)

  $ 1,029      $ 21,287      $ 28,448      $ (49,735   $ 1,029   

Adjustments to reconcile net income (loss) to net cash provided by (used in) operating activities:

         

Equity in earnings of subsidiaries, net of tax

    (49,895     348        —          49,547        —     

Non-cash interest expense, including amortization of original issue discounts and write-off of deferred financing costs

    5,219        59        —          —          5,278   

Depreciation and amortization

    2,074        57,303        48,086        (61     107,402   

Non-cash stock-based compensation expense

    1,007        1,377        1,490        —          3,874   

Impairment of inventory

    —          5        —          —          5   

Impairment of long-lived assets

    —          134        —          —          134   

Loss on sale of fixed assets

    —          508        58        —          566   

Equity earnings of unconsolidated entities, net of tax

    (660     —          (2,736     (16     (3,412

Deferred income taxes

    (11,105     (614     (2,033     —          (13,752

Changes in assets and liabilities, net of acquisitions:

         

Accounts receivable, net

    —          (3,721     (9,221     —          (12,942

Inventories, net

    —          13,288        (3,672     (265     9,351   

Prepaid expenses and other current assets

    10,526        (2,813     (4,192     —          3,521   

Accounts payable

    (863     (3,474     (13,469     —          (17,806

Accrued expenses and other current liabilities

    (14,901     27,920        (9,034     —          3,985   

Other non-current liabilities

    4,309        (9,400     19,717        71        14,697   

Intercompany payable (receivable)

    131,413        (109,319     (22,094     —          —     
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Net cash provided by (used in) operating activities

    78,153        (7,112     31,348        (459     101,930   
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Cash Flows from Investing Activities:

         

Decrease in restricted cash

    —          —          6,302        —          6,302   

Purchases of property, plant and equipment

    (4     (14,608     (16,232     459        (30,385

Proceeds from sale of property, plant and equipment

    —          201        326        —          527   

Cash paid for acquisitions, net of cash acquired

    (22,500     —          (15,508     —          (38,008

Cash received from equity method investment

    —          —          6,066        —          6,066   

Cash received (paid) for marketable securities

    —          (5     3        —          (2

Increase in other assets

    (6,144     (532     (1,878     —          (8,554
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Net cash provided by (used in) investing activities

    (28,648     (14,944     (20,921     459        (64,054
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Cash Flows from Financing Activities:

         

Cash paid for financing costs

    (1,876     —          —          —          (1,876

Cash paid for contingent purchase price consideration

    (48     —          —          —          (48

Proceeds from issuance of common stock, net of issuance costs

    7,674        —          —          —          7,674   

Proceeds from long-term debt

    198,000        951        190        —          199,141   

Payments on long-term debt

    (10,750     (356     (5,805     —          (16,911

Net proceeds under revolving credit facilities

    —          —          1,339        —          1,339   

Payments on short-term debt

    (6,240     —          —          —          (6,240

Cash paid for dividends

    (5,323     —          —          —          (5,323

Excess tax benefits on exercised stock options

    98        48        2        —          148   

Principal payments on capital lease obligations

    —          (502     (1,218     —          (1,720
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Net cash provided by (used in) financing activities

    181,535        141        (5,492     —          176,184   
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Foreign exchange effect on cash and cash equivalents

    (429     73        1,220        —          864   
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Net increase (decrease) in cash and cash equivalents

    230,611        (21,842     6,155        —          214,924   

Cash and cash equivalents, beginning of period

    12,451        85,838        200,884        —          299,173   
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Cash and cash equivalents, end of period

  $ 243,062      $ 63,996      $ 207,039      $ —        $ 514,097   
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

 

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CONSOLIDATING STATEMENT OF CASH FLOWS

For the Three Months Ended March 31, 2011

(in thousands)

 

     Issuer     Guarantor
Subsidiaries
    Non-Guarantor
Subsidiaries
    Eliminations     Consolidated  

Cash Flows from Operating Activities:

          

Net income (loss)

   $ 277      $ 16,975      $ 5,223      $ (22,198   $ 277   

Adjustments to reconcile net income (loss) to net cash provided by (used in) operating activities:

          

Equity in earnings of subsidiaries, net of tax

     (22,053     —          —          22,053        —     

Non-cash interest expense, including amortization of original issue discounts and write-off of deferred financing costs

     1,747        1,718        138        —          3,603   

Depreciation and amortization

     873        65,666        28,635        (199     94,975   

Non-cash stock-based compensation expense

     1,713        2,147        1,948        —          5,808   

Impairment of inventory

     —          —          294        —          294   

Impairment of long-lived assets

     —          —          230        —          230   

Impairment of intangible assets

     —          2,935        —          —          2,935   

Loss on sale of fixed assets

     —          304        175        —          479   

Gain on sales of marketable securities

     —          —          (333     —          (333

Equity earnings of unconsolidated entities, net of tax

     (468     —          (490     (53     (1,011

Deferred income taxes

     19,469        (22,801     (9,906     —          (13,238

Other non-cash items

     1,748        (335     193        —          1,606   

Changes in assets and liabilities, net of acquisitions:

          

Accounts receivable, net

     —          (2,045     (3,294     —          (5,339

Inventories, net

     —          12,150        (1,381     294        11,063   

Prepaid expenses and other current assets

     (5,180     (6,541     (12,752     —          (24,473

Accounts payable

     295        (1,372     (4,858     —          (5,935

Accrued expenses and other current liabilities

     (22,755     41,218        (3,544     (124     14,795   

Other non-current liabilities

     (17     212        1,229        —          1,424   

Intercompany payable (receivable)

     63,737        (104,146     40,409        —          —     
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Net cash provided by (used in) operating activities

     39,386        6,085        41,916        (227     87,160   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Cash Flows from Investing Activities:

          

Decrease in restricted cash

     —          —          3        —          3   

Purchases of property, plant and equipment

     (19     (15,440     (13,657     172        (28,944

Proceeds from sale of property, plant and equipment

     —          83        121        —          204   

Proceeds from disposition of business

     —          —          11,490        —          11,490   

Cash paid for acquisitions, net of cash acquired

     (34,103     (3,153     (57,643     —          (94,899

Cash received for marketable securities

     —          —          6,982        —          6,982   

Increase in other assets

     (3,958     (6,360     (1,784     —          (12,102
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Net cash provided by (used in) investing activities

     (38,080     (24,870     (54,488     172        (117,266
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Cash Flows from Financing Activities:

          

Cash paid for financing costs

     (68     (12     —          —          (80

Cash paid for contingent purchase price consideration

     (12,975     (247     —          —          (13,222

Proceeds from issuance of common stock, net of issuance costs

     11,824        —          —          —          11,824   

Repurchase of preferred stock

     (49,380     —          —          —          (49,380

Proceeds from long-term debt

     —          937        —          —          937   

Payments on long-term debt

     —          (2,856     (744     —          (3,600

Net proceeds under revolving credit facilities

     —          —          133        —          133   

Repurchase of common stock

     (618     —          —          —          (618

Excess tax benefits on exercised stock options

     872        198        99        —          1,169   

Principal payments on capital lease obligations

     —          (461     (192     —          (653

Other

     (34     —          (210     —          (244
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Net cash used in financing activities

     (50,379     (2,441     (914     —          (53,734
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Foreign exchange effect on cash and cash equivalents

     —          223        922        55        1,200   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Net decrease in cash and cash equivalents

     (49,073     (21,003     (12,564     —          (82,640

Cash and cash equivalents, beginning of period

     101,666        116,112        183,528        —          401,306   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Cash and cash equivalents, end of period

   $ 52,593      $ 95,109      $ 170,964      $ —        $ 318,666   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

 

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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 impact of our research and development activities, potential new product and technology achievements, the potential for selective acquisitions, including acquisitions of health management businesses outside the United States, our ability to improve our working capital and operating margins, our expectations with respect to Apollo, our integrated health management technology platform, our ability to improve care and lower healthcare costs for both providers and patients, our predictions regarding any product recall, the scope of any recall, the impact of changes to our quality control release methods, the financial consequences of any recall or our revised and future quality control release methods, our predictions regarding our ability to meet customer demand, 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 for the year ended December 31, 2011 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.

Overview

We enable individuals to take charge of improving their health and quality of life at home, under medical supervision, 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, infectious disease, toxicology, diabetes, oncology and women’s health. We are continuing to expand our product and service offerings in all of these categories.

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 home coagulation monitoring business, which supports doctors’ and patients’ efforts to monitor warfarin therapy using our INRatio blood coagulation monitoring system, continues to represent an early example of this. We have also continued to introduce our integrated health management technology platform, called Apollo, to our customers since its launch on January 1, 2010. Using a sophisticated data engine for acquiring and analyzing information, combined with a state of the art touch engine 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.

We have continued to grow through strategic acquisitions. With our November 2011 acquisitions of Axis-Shield plc, or Axis-Shield, and Arriva Medical, LLC, or Arriva, we have entered the diabetes diagnostics market, and we expect our presence in this field to grow. We also continued to expand our toxicology business, particularly in the growing market for pain management and medication monitoring services. We have also acquired software solutions that will further our efforts to connect healthcare providers with point of care and other patient data.

We have also continued to lay the groundwork for future revenue and earnings growth by focusing our efforts on new product development and introductions. Our important new products, including the epoc System, the Alere CD4 Analyzer and the Alere Heart Check System, have begun to penetrate the markets into which they have been launched, and we expect this trend to continue. We are also focused on expanding our global sales force. We also continued to build awareness and acceptance for our two novel biomarkers, NGAL and placental growth factor, or PLGF.

Recent Developments

        In March 2012, the Food & Drug Administration, or FDA, began an inspection of our San Diego facility related to our Alere Triage products. During the inspection, the FDA expressed concern about the alignment between certain aspects of our labeling for the Alere Triage products and the quality control release method that had been in effect prior to the inspection. To our knowledge, the FDA has not yet closed the inspection and has not issued any inspectional observations on Form 483. We are continuing to engage in discussions with the FDA regarding the Alere Triage products and have adopted an interim revised release method which we have been shipping against since early April 2012, with plans to further tighten the release method by September 30, 2012. Although the discussions with the FDA are ongoing, we expect that resolution of the issues raised by the FDA will involve a recall of unexpired lots of Alere Triage products that do not satisfy the revised quality control release method set through such resolution. Based on customer order patterns, expected customer inventory levels and the passage of time between March 31, 2012 and the date of any potential recall, we do not believe that the quantity or value of products that were sold on or before March 31, 2012 that may ultimately be returned will be material and, accordingly, we do not believe that any such recall will have a material impact on our results of operations for the quarter ended March 31, 2012. However, because the quality control release methods that we will apply in the future have not been determined, at this time we are unable to determine the scope of any anticipated recall, including the type and number of products that may be returned. Similarly, we are unable to determine the impact on our ability to ship existing inventory of, and to continue to manufacture, Alere Triage products that satisfy such release methods. Consequently, we are also unable to determine whether the anticipated recall or the revised release methods will have a material impact on our revenues, results of operations, earnings, cash flows or financial condition.

Despite these uncertainties, we expect that the modifications necessary to meet any interim and final release methods will lead to increased manufacturing costs for these products. We also anticipate that our ability to supply certain Alere Triage meter-based products may be limited, which may adversely affect revenues from sales of these products. For the first quarter of 2012, revenues from Triage cardiology and toxicology products sold in the U.S. totaled approximately $69.0 million. Of this amount, approximately $18.0 million related to BNP products that run on the Beckman Coulter automated platforms and which are not impacted by this matter. Of the remainder, approximately $31.0 million related to BNP, D-dimer and Toxicology tests, and approximately $20.0 million related to our cardiology panel tests. The interim and final release methods are expected to adversely impact our ability to supply the market with our cardiology panel tests and may also impact our BNP, D-dimer and Toxicology tests. At this time, we are unable to predict the scope or duration of any product shortages that we may encounter. We anticipate that any effort to substantially increase production to satisfy customer demand in the short term will lead to increased manufacturing costs. Our discussions with the FDA are ongoing and actual future results may be different than our current expectations, as summarized above.

Also, in May 2012, we received a subpoena from the Office of Inspector General of the Department of Health and Human Services. The subpoena seeks documents relating primarily to the quality control testing and performance characteristics of Alere Triage products. We are cooperating with the government and are in the process of responding to the subpoena.

We are unable to predict when these matters will be resolved, what action, if any, the government will take in connection with these matters or what impact, if any, these matters or ensuing proceedings, if any, will have on our financial condition, results of operations or cash flows.

Financial Highlights

 

   

Net revenue increased by $88.7 million, or 15%, to $671.1 million for the three months ended March 31, 2012, from $582.5 million for the three months ended March 31, 2011.

 

   

Gross profit increased by $46.9 million, or 15%, to $353.1 million for the three months ended March 31, 2012, from $306.2 million for the three months ended March 31, 2011.

 

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For the three months ended March 31, 2012, we generated a net loss available to common stockholders of $4.1 million, or $(0.05) per basic common share. For the three months ended March 31, 2011, we generated net income available to common stockholders of $8.1 million, or $0.09 per basic and diluted common share.

Results of Operations

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 $93.4 million, or 16%, to $668.2 million for the three months ended March 31, 2012, from $574.8 million for the three months ended March 31, 2011. Excluding the impact of currency translation, net product sales and services revenue for the three months ended March 31, 2012 increased by $96.8 million, or 17%, compared to the three months ended March 31, 2011. Net product sales and services revenue by business segment for the three months ended March 31, 2012 and 2011 are as follows (in thousands):

 

     Three Months Ended March 31,      %  
     2012      2011      Change  

Professional diagnostics

   $ 515,449       $ 409,785         26

Health management

     130,784         143,063         (9 )% 

Consumer diagnostics

     21,988         21,947         —  
  

 

 

    

 

 

    

Net product sales and services revenue

   $ 668,221       $ 574,795         16
  

 

 

    

 

 

    

Professional Diagnostics

The following table summarizes our net product sales and services revenue from our professional diagnostics business segment by groups of similar products and services for the three months ended March 31, 2012 and 2011 (in thousands):

 

     Three Months Ended March 31,      %  
     2012      2011      Change  

Cardiology

   $ 138,826       $ 129,855         7

Infectious disease

     151,016         140,426         8

Toxicology

     121,740         85,504         42

Diabetes

     28,161         —           N/A   

Other

     75,706         54,000         40
  

 

 

    

 

 

    

Professional diagnostics net product sales and services revenue

   $ 515,449       $ 409,785         26
  

 

 

    

 

 

    

Net product sales and services revenue from our professional diagnostics business segment increased by $105.7 million, or 26%, to $515.4 million for the three months ended March 31, 2012, from $409.8 million for the three months ended March 31, 2011. Excluding the impact of currency translation, net product sales and services revenue from our professional diagnostics business segment increased by $109.4 million, or 27%, comparing the three months ended March 31, 2012 to the three months ended March 31, 2011. Revenue increased primarily as a result of acquisitions, which contributed an aggregate of $95.6 million of such increase. New product sales continued to increase, achieving $13.7 million in the first quarter of 2012, with particular traction in Europe and Asia. We expect this trend to continue and anticipate that, as our new platforms achieve increased medical adoption, their underlying consumable sales will drive an expanding organic growth rate. Partially offsetting these increases in net product sales and services revenue, was a decrease in our North American flu-related net product sales during the three months ended March 31, 2012, as compared to the three months ended March 31, 2011. Net product sales from our North American flu-related sales decreased approximately $12.9 million, from $19.5 million during the three months ended March 31 2011 to $6.6 million during the three months ended March 31, 2012, as a result of lower than normal flu levels observed in 2012 than the more typical flu levels observed in 2011. Excluding the impact of acquisitions and the decrease in flu-related sales during the comparable periods, the currency-adjusted organic growth for our professional diagnostics net product sales and services revenue was approximately $27.1 million, or 6.9%.

 

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Health Management

The following table summarizes our net product sales and services revenue from our health management business segment by groups of similar products and services for the three months ended March 31, 2012 and 2011 (in thousands):

 

     Three Months Ended March 31,      %  
     2012      2011      Change  

Disease and case management

   $ 53,380       $ 61,455         (13 )% 

Wellness

     27,026         29,805         (9 )% 

Women’s and children’s health

     29,771         28,575         4

Patient self-testing services

     20,607         23,228         (11 )% 
  

 

 

    

 

 

    

Health management net product sales and services revenue

   $ 130,784       $ 143,063         (9 )% 
  

 

 

    

 

 

    

Our health management net product sales and services revenue decreased by $12.3 million, or 9%, to $130.8 million for the three months ended March 31, 2012, from $143.1 million for the three months ended March 31, 2011. Net product sales and services revenue in our health management segment was adversely impacted by the increasingly competitive environment, including pricing pressures, the impact of health plans in-sourcing less differentiated services, such as disease and case management, and state budget pressures.

Consumer Diagnostics

Net product sales and services revenue from our consumer diagnostics business segment remained flat, comparing the three months ended March 31, 2012 to the three months ended March 31, 2011. Net product sales by our 50/50 joint venture with P&G, or SPD, were $46.2 million during the three months ended March 31, 2012, as compared to $49.8 million during the three months ended March 31, 2011.

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 $4.8 million, or 62%, to $2.9 million for the three months ended March 31, 2012, from $7.7 million for the three months ended March 31, 2011. The decrease in royalty revenue was largely driven by an amendment to our license agreement with Quidel during 2011 whereby the license agreement was converted to a fully paid-up license. As a result of the amendment, we did not record royalty revenue from Quidel during the three months ended March 31, 2012 and do not anticipate recording royalty revenue from Quidel in the future. The remaining decrease was a result of lower royalties earned on existing license agreements during the three months ended March 31, 2012, as compared to the three months ended March 31, 2011.

Gross Profit and Margin. Gross profit increased by $46.9 million, or 15%, to $353.1 million for the three months ended March 31, 2012, from $306.2 million for the three months ended March 31, 2011. The increase in gross profit during the three months ended March 31, 2012 compared to the three months ended March 31, 2011 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 included amortization expense of $20.4 million and $17.0 million for the three months ended March 31, 2012 and 2011, respectively. Amortization expense of $20.4 million for the three months ended March 31, 2012, includes $4.7 million of amortization relating to the write-up of inventory to fair value in connection with the acquisition of Axis-Shield.

Overall gross margin for both the three months ended March 31, 2012 and 2011 was 53%.

Gross Profit from Net Product Sales and Services Revenue, Total and by Business Segment. Gross profit from net product sales and services revenue increased by $51.4 million, or 17%, to $351.8 million for the three months ended March 31, 2012, from $300.4 million for the three months ended March 31, 2011. Gross profit from net product sales and services revenue by business segment for the three months ended March 31, 2012 and 2011 are as follows (in thousands):

 

     Three Months Ended March 31,      %  
     2012      2011      Change  

Professional diagnostics

   $ 290,909       $ 228,122         28

Health management

     57,369         67,734         (15 )% 

Consumer diagnostics

     3,529         4,536         (22 )% 
  

 

 

    

 

 

    

Gross profit from net product sales and services revenue

   $ 351,807       $ 300,392         17
  

 

 

    

 

 

    

 

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Professional Diagnostics

Gross profit from our professional diagnostics net product sales and services revenue increased by $62.8 million, or 28%, to $290.9 million for the three months ended March 31, 2012, compared to $228.1 million for the three months ended March 31, 2011, principally as a result of gross profit earned on revenue from acquired businesses and organic growth, as discussed above. Gross profit was negatively impacted comparing the three months ended March 31, 2012 to the three months ended March 31, 2011, as a result of a decrease in our North American flu sales, as discussed above.

As a percentage of our professional diagnostics net product sales and services revenue, gross margin for both the three months ended March 31, 2012 and 2011 was 56%.

Health Management

Gross profit from our health management net product sales and services revenue decreased by $10.4 million, or 15%, to $57.4 million for the three months ended March 31, 2012, compared to $67.7 million for the three months ended March 31, 2011, primarily as a result of the increasingly competitive environment, including pricing pressures, and other adverse factors on our health management net product sales and services revenues, as discussed above.

As a percentage of our health management net product sales and services revenue, gross margin for the three months ended March 31, 2012 and 2011 was 44% and 47%, respectively. The lower margin percentage earned during 2012 is primarily a result of the increasingly competitive environment, including pricing pressures, and other adverse factors on our health management net product sales and services revenues, as discussed above.

Consumer Diagnostics

Gross profit from our consumer diagnostics net product sales and services revenue decreased by $1.0 million, or 22%, to $3.5 million for the three months ended March 31, 2012, compared to $4.5 million for the three months ended March 31, 2011. The decrease in gross margin was primarily the result of a one-time cost of goods sold adjustment totaling approximately $0.7 million related to our manufacturing agreement with SPD recorded during the three months ended March 31, 2012.

As a percentage of net product sales and services revenue, gross margin for the three months ended March 31, 2012 and 2011 was 16% and 21%, respectively.

Research and Development Expense. Research and development expense increased by $2.5 million, or 7%, to $39.0 million for the three months ended March 31, 2012, from $36.5 million for the three months ended March 31, 2011. Restructuring charges associated with our various restructuring plans to integrate our newly-acquired businesses totaling approximately $0.6 million and $18,000 were included in research and development expense for the three months ended March 31, 2012 and 2011, respectively. Amortization expense of $2.7 million and $2.3 million was included in research and development expense for the three months ended March 31, 2012 and 2011, respectively.

Research and development expense as a percentage of net revenue was 6% for each of the three months ended March 31, 2012 and 2011.

Sales and Marketing Expense. Sales and marketing expense increased by $25.4 million, or 19%, to $158.6 million for the three months ended March 31, 2012, from $133.2 million for the three months ended March 31, 2011. The increase in sales and marketing expense primarily relates to additional spending related to newly-acquired businesses. Restructuring charges associated with our various restructuring plans to integrate our newly-acquired businesses totaling approximately $0.8 million and $1.0 million were included in sales and marketing expense for the three months ended March 31, 2012 and 2011, respectively. Amortization expense of $57.8 million and $52.2 million was included in sales and marketing expense for the three months ended March 31, 2012 and 2011, respectively.

Sales and marketing expense as a percentage of net revenue was 24% and 23% for the three months ended March 31, 2012 and 2011, respectively.

General and Administrative Expense. General and administrative expense increased by approximately $14.9 million, or 14%, to $120.4 million for the three months ended March 31, 2012, from $105.6 million for the three months ended March 31, 2011. The increase in general and administrative expense relates primarily to additional spending related to newly-acquired businesses. During the three months ended March 31, 2012 and 2011, we recorded $5.0 million of expense and $1.4 million of expense, respectively, in connection with fair value adjustments to acquisition-related contingent consideration obligations. Acquisition-related costs of $1.5 million and $1.9 million were included in general and administrative expense for the three months ended March 31, 2012 and 2011, respectively. Restructuring charges

 

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associated with our various restructuring plans to integrate our newly-acquired businesses totaling approximately $3.1 million and $3.8 million were included in general and administrative expense for the three months ended March 31, 2012 and 2011, respectively. Amortization expense of $2.0 million and $4.7 million was included in general and administrative expense for the three months ended March 31, 2012 and 2011, respectively.

General and administrative expense as a percentage of net revenue was 18% for each of the three months ended March 31, 2012 and 2011.

Interest Expense. Interest expense includes interest charges and the amortization of deferred financing costs and original issue discounts associated with certain debt issuances. Interest expense increased by $12.4 million, or 32%, to $50.7 million for the three months ended March 31, 2012, from $38.3 million for the three months ended March 31, 2011. The increase is principally due to higher interest expense recorded in connection with higher outstanding debt balances and applicable interests rates during the first quarter of 2012 under our secured credit facility, compared to the outstanding debt balances and applicable interest rates under our previous secured credit facility during the first quarter of 2011.

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 March 31,        
     2012     2011     Change  

Interest income

   $ 562      $ 473      $ 89   

Foreign exchange gains (losses), net

     (774     (3,143     2,369   

Other

     12,043        5,006        7,037   
  

 

 

   

 

 

   

 

 

 

Total other income (expense), net

   $ 11,831      $ 2,336      $ 9,495   
  

 

 

   

 

 

   

 

 

 

Foreign exchange gains (losses), net for the three months ended March 31, 2011 include a $1.9 million realized foreign currency loss associated with the settlement of an acquisition-related contingent consideration obligation. Other income of $12.0 million for the three months ended March 31, 2012 includes a $13.5 million final royalty termination payment received from Quidel. Other income of $5.0 million for the three months ended March 31, 2011 includes $3.0 million of prior period royalty income and a $1.8 million reversal of a prior period legal settlement reserve no longer deemed necessary.

Benefit for Income Taxes. The benefit for income taxes decreased by $2.9 million to a $1.5 million benefit for the three months ended March 31, 2012 from a $4.3 million benefit for the three months ended March 31, 2011. The effective tax rate was 38% for the three months ended March 31, 2012 compared to 86% for the three months ended March 31, 2011. The income tax benefit for the three months ended March 31, 2012 and 2011 relates to federal, foreign and state income tax provisions (benefits). The effective income tax rate and benefit for income taxes decrease is primarily due to the expiration of the federal research and development tax credit during 2011. In addition, during the three months ended March 31, 2011, there was a discrete benefit for the reversal of certain capital loss valuation allowances and a favorable impact of a tax rate reduction for one of our German subsidiaries.

Equity Earnings in Unconsolidated Entities, Net of Tax. Equity earnings in unconsolidated entities is 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 months ended March 31, 2012 reflects the following: (i) our 50% interest in SPD in the amount of $2.8 million, (ii) our 40% interest in Vedalab S.A., or Vedalab, in the amount of $(0.1) million and (iii) our 49% interest in TechLab, Inc., or TechLab, in the amount of $0.7 million. Equity earnings in unconsolidated entities, net of tax for the three months ended March 31, 2011 reflects the following: (i) our 50% interest in SPD in the amount of $0.4 million, (ii) our 40% interest in Vedalab in the amount of $0.1 million and (iii) our 49% interest in TechLab in the amount of $0.5 million.

Net Income (Loss) Available to Common Stockholders. For the three months ended March 31, 2012, we generated a net loss available to common stockholders of $4.1 million, or $0.05 per basic common share. For the three months ended March 31, 2011, we generated net income available to common stockholders of $8.1 million, or $0.09 per basic and diluted common share. Net income available to common stockholders reflects $5.3 million and $5.8 million of preferred stock dividends paid during the three months ended March 31, 2012 and 2011, respectively, and $13.7 million of income associated with the repurchase of preferred stock during the three months ended March 31, 2011. See Note 5 of the accompanying consolidated financial statements for the calculation of net income (loss) per common share.

 

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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 future operating margins and grow our business through new product and service offerings and by continuing to leverage our strong intellectual property position. As of March 31, 2012, we have $514.1 million of cash and cash equivalents, of which $312.2 million was held by domestic subsidiaries and $201.9 million was held by foreign entities. Repatriation of cash held by foreign entities could be subject to adverse tax implications, including incremental U.S. tax liabilities and potential foreign withholding tax liabilities.

We may also utilize our secured credit facility (See Note 10) or other new sources of financing to fund a portion of our capital needs and other commitments, including our contractual contingent consideration obligations and future acquisitions. As of March 31, 2012, we did not have any borrowings outstanding under the $250.0 million revolving line of credit under our secured credit facility, and the full amount of that line of credit was available to us. 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 covenants which expressly restrict our ability to incur additional indebtedness and conduct other financings. As of March 31, 2012, we had $3.5 billion in outstanding indebtedness comprised of $2.3 billion under our secured credit facility, $400.0 million of 8.625% subordinated notes due 2018, $391.6 million of 9% senior subordinated notes due 2016, $245.8 million of 7.875% senior notes due 2016 and $150.0 million of 3% senior subordinated convertible notes due 2016. The applicable interest rate margins under our secured credit facility represent an increase of between approximately 0.75% and 2.25% (depending on the type of loan and the type of interest rate involved and on our applicable leverage ratios) over the applicable margins under our former secured credit facility. And, as a result of this increase in applicable interest rates, the 1.00% floor with respect to the base Eurodollar Rate (as defined in the senior credit facility) for “B” term loans, “Incremental B-1” term loans and “Incremental B-2” term loans under our secured credit facility that are based on the Eurodollar Rate, margins and the larger amount outstanding under our secured credit facility, we anticipate that our aggregate interest expense in future periods will exceed our aggregate interest expense in 2011.

If the capital and credit markets experience volatility or the availability of funds is limited, we may incur increased costs associated with issuing debt instruments. In addition, it is possible that our ability to access the capital and credit markets could be limited by these or other factors at a time when we would like, or need, to do so, which could have an adverse 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 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 rights. 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.

On April 2, 2012, we completed our acquisition of eScreen, Inc., or eScreen, headquartered in Overland Park, Kansas. eScreen is a technology-enabled provider of employment screening solutions for hiring and maintaining healthier and more efficient workforces. The preliminary aggregate purchase price was approximately $270.0 million, subject to certain post-closing adjustments, which was paid in cash.

Cash Flow Summary

(in thousands)

 

     Three Months Ended
March  31,
 
     2012     2011  

Net cash provided by operating activities

   $ 101,930      $ 87,160   

Net cash used in investing activities

     (64,054     (117,266

Net cash provided by (used in) financing activities

     176,184        (53,734

Foreign exchange effect on cash and cash equivalents

     864        1,200   
  

 

 

   

 

 

 

Net increase (decrease) in cash and cash equivalents

     214,924        (82,640

Cash and cash equivalents, beginning of period

     299,173        401,306   
  

 

 

   

 

 

 

Cash and cash equivalents, end of period

   $ 514,097      $ 318,666   
  

 

 

   

 

 

 

 

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Summary of Changes in Cash Position

As of March 31, 2012, we had cash and cash equivalents of $514.1 million; a $214.9 million increase from December 31, 2011. Our primary sources of cash during the three months ended March 31, 2012 included $101.9 million generated by our operating activities, approximately $198.0 million of proceeds received in connection with the “Incremental B-2” term loans entered into as part of our secured credit facility, $7.7 million from common stock issuances under employee stock option and stock purchase plans and a $6.1 million return of capital from SPD. Our primary uses of cash during the three months ended March 31, 2012 related to $38.0 million net cash paid for acquisitions, $29.9 million of capital expenditures, net of proceeds from the sale of equipment, $16.9 million related to the repayment of long-term debt obligations, $8.6 million related to an increase in other assets, $6.2 million related to the repayment of short-term debt obligations and $5.3 million for cash dividends paid on our Series B Preferred stock. Fluctuations in foreign currencies positively impacted our cash balance by $0.9 million during the three months ended March 31, 2012.

Cash Flows from Operating Activities

Net cash provided by operating activities during the three months ended March 31, 2012 was $101.9 million, which resulted from net income of $1.0 million, $100.1 million of non-cash items and $0.8 million of cash provided by changes in net working capital requirements during the period. The $100.1 million of non-cash items included, among other items, $107.4 million related to depreciation and amortization, $5.3 million of interest expense related to the amortization of deferred financing costs and original issue discounts and $3.9 million related to non-cash stock-based compensation, partially offset by a $13.8 million decrease related to changes in our deferred tax assets and liabilities, which partially resulted from amortization of intangible assets, and a $3.4 million decrease attributable to equity earnings in unconsolidated entities.

Cash Flows from Investing Activities

Our investing activities during the three months ended March 31, 2012 utilized $64.1 million of cash, including $38.0 million net cash paid for acquisitions, $29.9 million of capital expenditures, net of proceeds from the sale of equipment and $8.6 million related to an increase in other assets, offset by a $6.1 million return of capital from SPD.

Cash Flows from Financing Activities

Net cash provided by financing activities during the three months ended March 31, 2012 was $176.2 million. Financing activities during the three months ended March 31, 2012 primarily included approximately $198.0 million of net proceeds received in connection with the “Incremental B-2” term loans entered into as part of our secured credit facility. We utilized approximately $16.9 million for the repayment of long-term debt obligations, $6.2 million for the repayment of short-term debt obligations and $5.3 million for cash dividends paid on our Series B Preferred stock. These cash payments were offset by $7.7 million of cash received from common stock issuances under employee stock option and stock purchase plans.

As of March 31, 2012, we had an aggregate of $17.5 million in outstanding capital lease obligations which are payable through 2017.

Income Taxes

As of December 31, 2011, we had approximately $216.4 million of domestic NOL and capital loss carryforwards and $209.5 million of foreign NOL and capital loss carryforwards, respectively, which either expire on various dates through 2031 or may be carried forward indefinitely. These losses are available to 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, 2011 included approximately $97.1 million of pre-acquisition losses at Matria, QAS, ParadigmHealth, Biosite, Cholestech, Redwood, HemoSense, Ischemia, Ostex International, Ionian and Twist. 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.

 

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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 March 31, 2012.

Contractual Obligations

On March 28, 2012, we entered into a third amendment to our secured credit facility, which provides for an additional term loan facility consisting of “Incremental B-2” term loans in the aggregate principal amount of $200.0 million. As of March 31, 2012, aggregate borrowings under the secured credit facility amounted to $2.3 billion. The table below summarizes our aggregate long-term debt obligations as of March 31, 2012 (in thousands).

 

     Payments Due by Period  
     Total      2012      2013-2014      2015-2016      Thereafter  

Long-term debt obligations

   $ 3,531,018       $ 43,766       $ 113,552       $ 1,663,710       $ 1,709,990   

With respect to our February 6, 2012 acquisition of AmMed Direct LLC, the terms of the acquisition agreement require us to pay an earn-out upon successfully meeting certain operational targets within six months of the acquisition date. The maximum amount of the earn-out payment is $2.0 million.

The addition of the AmMed obligation is the only significant change in our principal contractual obligations since December 31, 2011, other than the changes described above with respect to our secured credit facility. Other contractual obligations that were presented in our Annual Report on Form 10-K for the year ended December 31, 2011 but are omitted below represent those that have not changed significantly since that date.

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, 2011. 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 for the year ended December 31, 2011.

Recent Accounting Pronouncements

See Note 17 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

Our market risks, and the ways we manage them, are summarized in Part II, Item 7A, “Quantitative and Qualitative Disclosures About Market Risk” of our 2011 Form 10-K. Market risks that were presented in our 2011 Form 10-K but

 

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are omitted below represent those that have not changed significantly since that date. The following discussion about our market risk disclosures involves forward-looking statements. Actual results could differ materially from those discussed in the forward-looking statements.

Interest Rate Risk

We are exposed to market risk from changes in interest rates primarily through our investing and financing activities. In addition, our ability to finance future acquisition transactions or fund working capital requirements may be impacted if we are not able to obtain appropriate financing at acceptable rates.

Our investing strategy to manage interest rate exposure is to invest in short-term, highly-liquid investments. Our investment policy also requires investment in approved instruments with an initial maximum allowable maturity of eighteen months and an average maturity of our portfolio that should not exceed six months, with at least $500,000 cash available at all times. Currently, our short-term investments are in money market funds with original maturities of 90 days or less. At March 31, 2012, our short-term investments approximated market value. At March 31, 2012, under the credit agreement for our secured credit facility we had (i) term loans in an aggregate outstanding principal amount of $2.3 billion (consisting of “A” term loans (including the “Delayed-Draw” term loans) in the aggregate principal amount of $909.4 million, “B” term loans in the aggregate principal amount of $920.4 million, “Incremental B-1” term loans in the aggregate principal amount of $249.4 million and “Incremental B-2” term loans in the aggregate principal amount of $200.0 million), and (ii) subject to our continued compliance with the credit agreement, the ability to borrow under a $250.0 million revolving line of credit, which includes a $50.0 million sublimit for the issuance of letters of credit. As of March 31, 2012, there were no outstanding borrowings under the revolving line of credit. Loans can be either Base Rate Loans or Eurodollar Rate Loans at our election, and interest accrues on loans and our other Obligations under the terms of the credit agreement as follows (with the terms referenced above and below in this paragraph having the meanings given to them in the credit agreement): (i) in the case of loans that are 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 loans that are 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 as in effect from time to time. The Eurodollar Rate is equal to the LIBOR rate and is set for a period of one, two, three or six months at our election. Applicable Margins for our “A” term loans (including the “Delayed-Draw” term loans) and revolving line of credit loans range from (i) with respect to such loans that are Base Rate Loans, 1.75% to 2.50% and (ii) with respect to such loans that are Eurodollar Rate Loans, 2.75% to 3.50%, in each case, depending upon our consolidated secured leverage ratio (as determined under the credit agreement). Applicable Margins for our “B” term loans, “Incremental B-1” term loans and “Incremental B-2” term loans range from (i) with respect to such loans that are Base Rate Loans, 2.50% to 3.25% and (ii) with respect to such loans that are Eurodollar Rate Loans, 3.50% to 4.25%, in each case, depending upon our consolidated secured leverage ratio. Interest on “B” term loans, “Incremental B-1” term loans and “Incremental B-2” term loans based on the Eurodollar Rate is subject to a 1.00% floor with respect to the base Eurodollar Rate. As of March 31, 2012, the “A” term loans (including the “Delayed-Draw” term loans), the “B” term loans, the “Incremental B-1” term loans and the “Incremental B-2” term loans bore interest (including applicable margins) at 2.99%, 4.50%, 4.50% and 4.50% per annum, respectively.

Assuming no changes in our consolidated secured leverage ratio, the effect of interest rate fluctuations on outstanding borrowings as of March 31, 2012 over the next twelve months is quantified and summarized as follows (in thousands):

 

     Interest Expense
Increase
 

Interest rates payable by us increase by 100 basis points

   $ 22,771   

Interest rates payable by us increase by 200 basis points

   $ 45,543   

 

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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 Quarterly Report on Form 10-Q. 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 Quarterly Report on Form 10-Q that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

PART II — OTHER INFORMATION

ITEM 1. LEGAL PROCEEDINGS.

Please see Part I, Item 2, “Management’s Discussion and Analysis of Financial Conditions and Results of Operations—Recent Developments” for a description of certain legal matters.

ITEM 1A. RISK FACTORS

This section updates and supplements the risk factors detailed in Part I, Item 1A, “Risk Factors,” of our Annual Report on Form 10-K for the fiscal year ended December 31, 2011, and should be read in conjunction with such disclosure. The risks described below may materially impact your investment in our company or may in the future, and, in some cases, already do materially affect us and our business, financial condition and results of operations. You should carefully consider these factors with respect to your investment in our securities.

We face risks and uncertainties relating to an ongoing FDA inspection and subpoena with respect to our Alere Triage products.

As we discuss under the heading “Recent Developments” in Part I, Item 2, “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” the FDA is conducting an inspection of our San Diego facility relating to our Alere Triage products, and we have received a subpoena from the Office of Inspector General of the Department of Health and Human Services seeking documents relating primarily to the quality control testing and performance characteristics of Alere Triage products. The inspection and subpoena may be expanded to cover other matters. We are unable to predict when these matters will be resolved, what action, if any, the government will take in connection with these matters or what impact, if any, these matters or ensuing proceedings, if any, will have on our financial condition, results of operations or cash flows. We anticipate that we will recall some or all of the Alere Triage products, and our ability to supply certain Alere Triage products may be limited, which may adversely affect revenues from sales of these products. We are unable to predict the scope of any product recall or the duration of any product shortage. We may experience shortages of products for which our inventory appears adequate, and our revenues and market share could be adversely affected by customer decisions to switch to competing products. We are unable to determine the extent to which our manufacturing costs will increase as a result of these matters or the impact of these matters on the profitability of these products. We cannot predict the impact of any revised quality control release methods on our manufacturing yields. Our discussions with the FDA could lead to further changes in our quality control release methods or other manufacturing or quality control procedures, which could result in additional product shortages or additional cost increases. In connection with these matters, we may face potential enforcement proceedings by the government, potential civil or criminal fines and penalties, including disgorgement of amounts received for any adulterated products, potential withdrawals of regulatory approvals, the possibility of injunctive relief, which could limit, modify or constrain our ability to manufacture, market and sell our products, possible exclusion from participation in government healthcare programs, such as Medicare and Medicaid, and potential product liability litigation. We are unable to predict the costs we may incur in responding to the subpoena or other potential investigations of these matters. Any of these risks and uncertainties could adversely affect our revenues, results of operations, cash flows and financial condition.

ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS

During the period covered by this report, we issued 4,000 shares of our common stock upon the exercise of warrants for cash, resulting in aggregate proceeds to us of $54,160. During the period covered by this report, we issued 2,803 shares of our common stock upon the net exercise of warrants to purchase 6,000 shares of our common stock, resulting in aggregate non-cash consideration to us of $81,240. The warrants were issued in 2002 in a private placement relating to an acquisition. The shares issued upon exercise of the warrants were offered and sold, in 7 separate transactions, pursuant to the exemption from registration afforded by Section 4(2) of the Securities Act of 1933, as amended, or the Securities Act.

 

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ITEM 6. EXHIBITS

Exhibits:

 

Exhibit
No.
  Description
    10.1   Third Amendment to Credit Agreement dated as of March 28, 2012 among Alere Inc., as Borrower, the Lenders party thereto and General Electric Capital Corporation, as Administrative Agent (incorporated by reference to Exhibit 10.4 to the Company’s Current Report on Form 8-K, event date March 28, 2012, filed on April 2, 2012)
  *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 Months Ended March 31, 2012 and 2011, (b) our Consolidated Statements of Comprehensive Income for the Three Months Ended March 31, 2012 and 2011, (c) our Consolidated Balance Sheets as of March 31, 2012 and December 31, 2011, (d) our Consolidated Statements of Cash Flows for the Three Months Ended March 31, 2012 and 2011 and (e) the Notes to such Consolidated Financial Statements.

 

* Filed herewith

 

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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: May 10, 2012  

/s/ David Teitel

  David Teitel
  Chief Financial Officer and an authorized officer

 

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