SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

Form 10-Q

x
þ

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

For the Quarterly Period Ended June 30,December 31, 2011

OR

¨
o

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

For the transition period from                    to                    

Commission file number0-14902

MERIDIAN BIOSCIENCE, INC.

Incorporated under the laws of Ohio

31-0888197

(I.R.S. Employer Identification No.)

3471 River Hills Drive

Cincinnati, Ohio 45244

(513) 271-3700

Indicate by a 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.

Yesþx    Noo¨

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).

Yesþx    Noo¨

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 definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer

 

x

  

Accelerated filer

 

¨

Large accelerated

Non-accelerated filerþ

 Accelerated filero

¨

  Non-accelerated filero

Smaller reporting company

 Smaller reporting companyo

¨

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).

Yeso¨     Noþx

Indicate the number of shares outstanding of each of the issuer’s classes of common stock, as of the latest practicable date.

Class

 Outstanding JulyJanuary 31, 20112012

Common Stock, no par value

 41,051,35641,253,959

 

 


MERIDIAN BIOSCIENCE, INC. AND SUBSIDIARIES

INDEX TO QUARTERLY REPORT ON FORM 10-Q

Page(s)
      
Page(s) 
PART I.  

FINANCIAL INFORMATION

  
Item 1.

Financial Statements (Unaudited)

Condensed Consolidated Statements of Operations
Three and Nine Months Ended June 30,December 31, 2011 and 2010

   1  
  

   2  
  

   3-4  
  

   5  
  

   6-126-10  
Item 2.  

   13-2110-16  
Item 3.  

   2116  
Item 4.

Controls and Procedures

   16  
PART II.

OTHER INFORMATION

Item 4. Controls and Procedures1A.

Risk Factors

   2117  
Item 6.

Exhibits

   17  
PART II. OTHER INFORMATIONSignature   18  
22
22
23

EX-10.4EX-31.1EX-31.2EX-32EX-101 INSTANCE DOCUMENTEX-101 SCHEMA DOCUMENTEX-101 CALCULATION LINKBASE DOCUMENTEX-101 LABELS LINKBASE DOCUMENTEX-101 PRESENTATION LINKBASE DOCUMENTEX-101 DEFINITION LINKBASE DOCUMENT

The Private Securities Litigation Reform Act of 1995 provides a safe harbor from civil litigation for forward-looking statements accompanied by meaningful cautionary statements. Except for historical information, 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, which may be identified by words such as “estimates”, “anticipates”, “projects”, “plans”, “seeks”, “may”, “will”, “expects”, “intends”, “believes”, “should” and similar expressions or the negative versions thereof and which also may be identified by their context. Such statements, whether expressed or implied, are based upon current expectations of the Company and speak only as of the date made. The Company assumes no obligation to publicly update or revise any forward-looking statements even if experience or future changes make it clear that any projected results expressed or implied therein will not be realized. These statements are subject to various risks, uncertainties and other factors that could cause actual results to differ materially, including, without limitation, the following: Meridian’s continued growth depends, in part, on its ability to introduce into the marketplace enhancements of existing products or new products that incorporate technological advances, meet customer requirements and respond to products developed by Meridian’s competition. While Meridian has introduced a number of internally developed products, there can be no assurance that it will be successful in the future in introducing such products on a timely basis. Meridian relies on proprietary, patented and licensed technologies, and the Company’s ability to protect its intellectual property rights, as well as the potential for intellectual property litigation, would impact its results. Ongoing consolidations of reference laboratories and formation of multi-hospital alliances may cause adverse changes to pricing and distribution. Recessionary pressures on the economy and the markets in which our customers operate, as well as adverse trends in buying patterns from customers can change expected results. Costs and difficulties in complying with laws and regulations, including those administered by the United States Food and Drug Administration, can result in unanticipated expenses and delays and interruptions to the sale of new and existing products. ChangesThe international scope of Meridian’s operations, including changes in the relative strength or weakness of the U.S. dollar and general economic conditions in foreign countries, can also change expected results.impact results and make them difficult to predict. One of Meridian’s main growth strategies is the acquisition of companies and product lines. There can be no assurance that additional acquisitions will be consummated or that, if consummated, will be successful and the acquired businesses will be successfully integrated into Meridian’s operations. There may be risks that acquisitions may disrupt operations and may pose potential difficulties in employee retention and there may be additional risks with respect to Meridian’s ability to recognize the benefits of acquisitions, including potential synergies and cost savings or the failure of acquisitions to achieve their plans and objectives. The Company cannot predict the possible impact of recently-enacted United States healthcare legislation and any similar initiatives in other countries on its results of operations. In addition to the factors described in this paragraph, Part I, Item 1A Risk Factors of our Form 10-K contains a list and description of uncertainties, risks and other matters that may affect the Company.


PART I. FINANCIAL INFORMATION

Item 1. Financial Statements

MERIDIAN BIOSCIENCE, INC. AND SUBSIDIARIES

Condensed Consolidated Statements of Operations (Unaudited)

(in thousands, except per share data)

                 
  Three Months Ended  Nine Months Ended 
  June 30,  June 30, 
  2011  2010  2011  2010 
NET SALES $40,052  $33,857  $118,374  $107,461 
                 
COST OF SALES  14,626   12,121   43,046   40,073 
             
                 
GROSS PROFIT  25,426   21,736   75,328   67,388 
             
                 
OPERATING EXPENSES                
Research and development  2,710   2,128   7,383   6,521 
Selling and marketing  6,143   4,287   17,847   13,495 
General and administrative  6,442   4,872   18,675   14,042 
European and global sales & marketing leadership reorganization        1,240    
Bioline Group transaction costs     673      673 
             
Total operating expenses  15,295   11,960   45,145   34,731 
             
                 
OPERATING INCOME  10,131   9,776   30,183   32,657 
                 
OTHER INCOME (EXPENSE)                
Interest income  26   29   70   90 
Other, net  36   (9)  357   (17)
             
Total other income (expense)  62   20   427   73 
             
                 
EARNINGS BEFORE INCOME TAXES  10,193   9,796   30,610   32,730 
                 
INCOME TAX PROVISION  3,357   3,372   10,489   11,405 
                 
             
NET EARNINGS $6,836  $6,424  $20,121  $21,325 
             
                 
BASIC EARNINGS PER COMMON SHARE $0.17  $0.16  $0.49  $0.53 
                 
DILUTED EARNINGS PER COMMON SHARE $0.17  $0.16  $0.49  $0.52 
                 
AVERAGE NUMBER OF COMMON SHARES OUTSTANDING — BASIC  40,737   40,535   40,680   40,510 
                 
EFFECT OF DILUTIVE STOCK OPTIONS  657   616   673   656 
                 
AVERAGE NUMBER OF COMMON SHARES OUTSTANDING — DILUTED  41,394   41,151   41,353   41,166 
             
                 
ANTI-DILUTIVE SECURITIES:                
Common share options  160   234   177   207 
             
                 
DIVIDENDS DECLARED PER COMMON SHARE $0.19  $0.19  $0.57  $0.55 
             

September 30,September 30,

Three Months Ended December 31,

    2011     2010 

NET SALES

    $40,266     $37,263 

COST OF SALES

     15,533      13,761 
    

 

 

     

 

 

 

GROSS PROFIT

     24,733      23,502 
    

 

 

     

 

 

 

OPERATING EXPENSES

        

Research and development

     2,273      2,309 

Selling and marketing

     5,568      5,475 

General and administrative

     6,643      6,628 

Plant consolidation costs

     444      —    
    

 

 

     

 

 

 

Total operating expenses

     14,928      14,412 
    

 

 

     

 

 

 

OPERATING INCOME

     9,805      9,090 

OTHER INCOME

        

Interest income

     5      17 

Other, net

     316      203 
    

 

 

     

 

 

 

Total other income

     321      220 
    

 

 

     

 

 

 

EARNINGS BEFORE INCOME TAXES

     10,126      9,310 

INCOME TAX PROVISION

     3,548      3,285 
    

 

 

     

 

 

 

NET EARNINGS

    $6,578     $6,025 
    

 

 

     

 

 

 

BASIC EARNINGS PER COMMON SHARE

    $0.16     $0.15 

DILUTED EARNINGS PER COMMON SHARE

    $0.16     $0.15 

AVERAGE NUMBER OF COMMON SHARES OUTSTANDING - BASIC

     41,067      40,615 

EFFECT OF DILUTIVE STOCK OPTIONS AND RESTRICTED SHARES AND UNITS

     420      679 

AVERAGE NUMBER OF COMMON SHARES OUTSTANDING - DILUTED

     41,487      41,294 
    

 

 

     

 

 

 

ANTI-DILUTIVE SECURITIES:

        

Common share options and restricted shares and units

     343      160 
    

 

 

     

 

 

 

DIVIDENDS DECLARED PER COMMON SHARE

    $0.19     $0.19 
    

 

 

     

 

 

 

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

 

Page 1


MERIDIAN BIOSCIENCE, INC. AND SUBSIDIARIES

Condensed Consolidated Statements of Cash Flows (Unaudited)

(dollars in thousands)

         
Nine Months Ended June 30, 2011  2010 
CASH FLOWS FROM OPERATING ACTIVITIES        
Net earnings $20,121  $21,325 
Non-cash items:        
Depreciation of property, plant and equipment  2,525   2,307 
Amortization of intangible assets  1,796   1,079 
Amortization of deferred illumigene contract costs  81    
Stock-based compensation  1,981   1,255 
Deferred income taxes  (1,622)  (108)
Loss on disposition of fixed assets  7   15 
Unrealized loss on auction-rate securities and rights, net     10 
Change in current assets  (10,176)  2,151 
Change in current liabilities  2,451   (4,327)
Other, net  (546)  (6)
       
Net cash provided by operating activities  16,618   23,701 
       
         
CASH FLOWS FROM INVESTING ACTIVITIES        
Purchases of property, plant and equipment  (7,666)  (3,681)
Purchases of intangibles and other assets  (12)   
Purchases of short-term investments     (1,000)
Proceeds from sales and calls of short-term investments     8,275 
       
Net cash (used for) provided by investing activities  (7,678)  3,594 
       
         
CASH FLOWS FROM FINANCING ACTIVITIES        
Dividends paid  (23,192)  (22,282)
Proceeds and tax benefits from exercises of stock options  1,481   559 
       
Net cash used for financing activities  (21,711)  (21,723)
       
         
Effect of Exchange Rate Changes on Cash and Equivalents  455   (1,383)
       
         
Net (Decrease) Increase in Cash and Equivalents  (12,316)  4,189 
         
Cash and Equivalents at Beginning of Period  37,879   54,030 
       
         
Cash and Equivalents at End of Period $25,563  $58,219 
       

September 30,September 30,

Three Months Ended December 31,

    2011   2010 

CASH FLOWS FROM OPERATING ACTIVITIES

      

Net earnings

    $6,578   $6,025 

Non-cash items included in net earnings:

      

Depreciation of property, plant and equipment

     903    845 

Amortization of intangible assets

     520    595 

Amortization of deferred illumigene contract costs

     149    —    

Stock-based compensation

     979    967 

Deferred income taxes

     (679   (955

(Gain) loss on disposition of fixed assets and other assets

     (23   4 

Change in current assets

     2,718    2,276 

Change in current liabilities

     1,452    3,177 

Other, net

     (100   665 
    

 

 

   

 

 

 

Net cash provided by operating activities

     12,497    13,599 
    

 

 

   

 

 

 

CASH FLOWS FROM INVESTING ACTIVITIES

      

Purchases of property, plant and equipment

     (1,052   (2,559

Proceeds from sale of assets

     400    —    

Purchases of intangibles and other assets

     (1,290   (12
    

 

 

   

 

 

 

Net cash used for investing activities

     (1,942   (2,571
    

 

 

   

 

 

 

CASH FLOWS FROM FINANCING ACTIVITIES

      

Dividends paid

     (7,803   (7,720

Proceeds and tax benefits from exercises of stock options

     269    739 
    

 

 

   

 

 

 

Net cash used for financing activities

     (7,534   (6,981
    

 

 

   

 

 

 

Effect of Exchange Rate Changes on Cash and Equivalents

     (442   (447
    

 

 

   

 

 

 

Net Increase in Cash and Equivalents

     2,579    3,600 

Cash and Equivalents at Beginning of Period

     23,626    37,879 
    

 

 

   

 

 

 

Cash and Equivalents at End of Period

    $26,205   $41,479 
    

 

 

   

 

 

 

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

 

Page 2


MERIDIAN BIOSCIENCE, INC. AND SUBSIDIARIES

Condensed Consolidated Balance Sheets (Unaudited)

(dollars in thousands)

ASSETS

         
  June 30,  September 30, 
  2011  2010 
CURRENT ASSETS        
Cash and equivalents $25,563  $37,879 
Accounts receivable, less allowances of $125 and $241  23,987   22,064 
Inventories  34,066   28,420 
Prepaid expenses and other current assets  6,571   5,071 
Deferred income taxes  2,335   1,871 
       
         
Total current assets  92,522   95,305 
       
         
PROPERTY, PLANT AND EQUIPMENT, at Cost        
Land  1,194   991 
Buildings and improvements  21,406   20,670 
Machinery, equipment and furniture  31,382   31,945 
Construction in progress  5,946   1,320 
       
Subtotal  59,928   54,926 
Less: accumulated depreciation and amortization  33,472   33,689 
       
         
Net property, plant and equipment  26,456   21,237 
       
         
OTHER ASSETS        
Goodwill  23,443   23,302 
Other intangible assets, net  11,632   13,327 
Restricted cash  1,000   1,000 
Deferred illumigene contract costs  2,643   231 
Other assets  255   239 
       
         
Total other assets  38,973   38,099 
       
     ��   
TOTAL ASSETS $157,951  $154,641 
       

September 30,September 30,
     December 31,
2011
(Unaudited)
     September 30,
2011
 

CURRENT ASSETS

        

Cash and equivalents

    $26,205     $23,626 

Accounts receivable, less allowances of $453 and $310

     24,023      24,844 

Inventories

     33,656      32,689 

Prepaid expenses and other current assets

     2,424      6,343 

Deferred income taxes

     3,098      2,852 
    

 

 

     

 

 

 

Total current assets

     89,406      90,354 
    

 

 

     

 

 

 

PROPERTY, PLANT AND EQUIPMENT, at Cost

        

Land

     1,176      1,184 

Buildings and improvements

     26,188      23,033 

Machinery, equipment and furniture

     34,121      32,408 

Construction in progress

     784      3,887 
    

 

 

     

 

 

 

Subtotal

     62,269      60,512 

Less: accumulated depreciation and amortization

     35,641      33,973 
    

 

 

     

 

 

 

Net property, plant and equipment

     26,628      26,539 
    

 

 

     

 

 

 

OTHER ASSETS

        

Goodwill

     22,699      23,124 

Other intangible assets, net

     11,648      10,947 

Restricted cash

     1,000      1,000 

Deferred illumigene contract costs, net

     3,577      3,304 

Other assets

     237      225 
    

 

 

     

 

 

 

Total other assets

     39,161      38,600 
    

 

 

     

 

 

 

TOTAL ASSETS

    $155,195     $155,493 
    

 

 

     

 

 

 

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

 

Page 3


MERIDIAN BIOSCIENCE, INC. AND SUBSIDIARIES

Condensed Consolidated Balance Sheets (Unaudited)

(dollars in thousands)

LIABILITIES AND SHAREHOLDERS’ EQUITY

         
  June 30,  September 30, 
  2011  2010 
CURRENT LIABILITIES        
Accounts payable $6,093  $4,466 
Accrued employee compensation costs  4,100   3,451 
Other accrued expenses  5,457   5,521 
Income taxes payable  1,532   1,086 
       
         
Total current liabilities  17,182   14,524 
       
         
DEFERRED INCOME TAXES  2,649   2,756 
         
COMMITMENTS AND CONTINGENCIES        
         
SHAREHOLDERS’ EQUITY        
Preferred stock, no par value, 1,000,000 shares authorized, none issued      
Common shares, no par value, 71,000,000 shares authorized, 41,048,269 and 40,654,286 shares issued, respectively      
Additional paid-in capital  97,577   94,529 
Retained earnings  39,106   42,177 
Accumulated other comprehensive income  1,437   655 
       
         
Total shareholders’ equity  138,120   137,361 
       
         
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY $157,951  $154,641 
       

September 30,September 30,
     December 31,
2011
(Unaudited)
   September 30,
2011
 

CURRENT LIABILITIES

      

Accounts payable

    $6,207   $5,548 

Accrued employee compensation costs

     4,035    4,235 

Other accrued expenses

     5,252    4,692 

Income taxes payable

     1,065    789 
    

 

 

   

 

 

 

Total current liabilities

     16,559    15,264 
    

 

 

   

 

 

 

DEFERRED INCOME TAXES

     933    1,705 

COMMITMENTS AND CONTINGENCIES

      

SHAREHOLDERS’ EQUITY

      

Preferred stock, no par value, 1,000,000 shares authorized, none issued

     —       —    

Common shares, no par value, 71,000,000 shares authorized, 41,247,545 and 41,237,120 shares issued, respectively

     —       —    

Additional paid-in capital

     101,095    100,010 

Retained earnings

     36,840    38,065 

Accumulated other comprehensive income

     (232   449 
    

 

 

   

 

 

 

Total shareholders’ equity

     137,703    138,524 
    

 

 

   

 

 

 

TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY

    $155,195   $155,493 
    

 

 

   

 

 

 

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

 

Page 4


MERIDIAN BIOSCIENCE, INC. AND SUBSIDIARIES

Condensed Consolidated Statement of Changes in Shareholders’ Equity (Unaudited)

(dollars and shares in thousands)

                         
              Accumulated        
  Common  Additional      Other      Total 
  Shares  Paid-In  Retained  Comprehensive  Comprehensive  Shareholders’ 
  Issued  Capital  Earnings  Income (Loss)  Income (Loss)  Equity 
   
Balance at September 30, 2010
  40,654  $94,529  $42,177  $655     $137,361 
Cash dividends paid        (23,192)         (23,192)
Exercise of stock options  212   1,067             1,067 
Issuance of restricted shares  182                 
Stock compensation expense     1,981             1,981 
Comprehensive income:                        
Net earnings        20,121     $20,121   20,121 
Foreign currency translation adjustment           1,203   1,203   1,203 
Other comprehensive income taxes           (421)  (421)  (421)
                        
Comprehensive income                 $20,903     
                   
Balance at June 30, 2011
  41,048  $97,577  $39,106  $1,437      $138,120 
                   

000000000000000000000000000000000000000000000000
  Common
Shares
Issued
  Additional
Paid-In
Capital
  Retained
Earnings
  Accumulated
Other
Comprehensive
Income (Loss)
  Comprehensive
Income (Loss)
  Total
Shareholders’
Equity
 

Balance at September 30, 2011

  41,237  $100,010  $38,065  $449   $138,524 

Cash dividends paid

  —      —      (7,803  —       (7,803

Exercise of stock options

  10   106   —      —       106 

Issuance of restricted shares, net of forfeitures

  (1  —      —      —       —    

Conversion of restricted stock units

  1   —      —      —       —    

Stock compensation expense

  —      979   —      —       979 

Comprehensive income:

      

Net earnings

  —      —      6,578   —     $6,578   6,578 

Other comprehensive income taxes

  —      —      —      363   363   363 

Foreign currency translation adjustment

  —      —      —      (1,044  (1,044  (1,044
     

 

 

  

Comprehensive income

     $5,897  
 

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

 

Balance at December 31, 2011

  41,247  $101,095  $36,840  $(232  $137,703 
 

 

 

  

 

 

  

 

 

  

 

 

   

 

 

 

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

 

Page 5


MERIDIAN BIOSCIENCE, INC. AND SUBSIDIARIES

Notes to Condensed Consolidated Financial Statements

Dollars in Thousands, Except Per Share Amounts

(Unaudited)

1.

1. Basis of Presentation

The interim condensed consolidated financial statements are unaudited and are prepared in accordance with accounting principles generally accepted in the United States of America for interim financial information, and the rules and regulations of the Securities and Exchange Commission. Certain information and footnote disclosures normally included in financial statements prepared in accordance with generally accepted accounting principles have been condensed or omitted pursuant to such rules and regulations. In the opinion of Management, the interim financial statements include all normal adjustments and disclosures necessary to present fairly the Company’s financial position as of June 30,December 31, 2011, the results of its operations for the three and nine month periods ended June 30,December 31, 2011 and 2010, and its cash flows for the ninethree month periods ended June 30,December 31, 2011 and 2010. These statements should be read in conjunction with the financial statements and footnotes thereto included in the Company’s fiscal 20102011 Annual Report on Form 10-K. Financial information as of September 30, 20102011 has been derived from the Company’s audited consolidated financial statements.

The results of operations for interim periods are not necessarily indicative of the results to be expected for the year.

2.

2. Significant Accounting Policies

(a)

Revenue Recognition and Accounts Receivable

Revenue is generally recognized from sales when product is shipped and title has passed to the buyer. Revenue for the U.S. Diagnostics operating segment is reduced at the date of sale for estimated rebates that will be claimed by customers. Management estimates accruals for rebate agreements based on data provided by these customers, estimates of inventories of our products held by these customers, historical statistics, current trends, and other factors. Changes to the accruals are recorded in the period that they become known. Our rebate accruals were $4,272 at June 30, 2011 and $5,273 at September 30, 2010.
Revenue for our Diagnostics operating segments includes bundled product revenue for ourillumigene®molecular test system. The bundled product includes a reader instrument, instrument accessories, and test kits. In many instances, amounts invoiced for theillumigene®test kits cover the reader instrument, accessories, and test kits. Revenue is recognized based on kit sales. Costs for the reader instruments are recognized in earnings over the period that we have a pricing agreement in effect with the customer, generally three years.
Life Science revenue for contract services may come from research and development services or manufacturing services, including process development work, or a combination of both. Revenue is recognized based on each of the deliverables in a given arrangement having distinct and separate customer pricing. Pricing is often subject to a competitive bidding process. Contract research and development services may be performed on a “time and materials” basis or “fixed fee” basis. For “time and materials” arrangements, revenue is recognized as services are performed and billed. For “fixed fee” arrangements, revenue is recognized upon completion and acceptance by the customer. For contract manufacturing services, revenue is generally recognized upon delivery of product and acceptance by the customer. In some cases, customers may request that we store on their behalf clinical grade biologicals that we produce under contract manufacturing agreements. These cases arise when customers do not have clinical grade storage facilities or do not want to risk contamination during transport. For such cases, revenue may be recognized on a bill-and-hold basis.

Revenue is generally recognized from sales when product is shipped and title has passed to the buyer. Revenue for the U.S. Diagnostics operating segment is reduced at the date of sale for estimated rebates that will be claimed by customers. Management estimates accruals for rebate agreements based on data provided by these customers, estimates of inventories of our products held by these customers, historical statistics, current trends, and other factors. Changes to the accruals are recorded in the period that they become known. Our rebate accruals were $4,311 at December 31, 2011 and $4,176 at September 30, 2011.

Revenue for our Diagnostics operating segments includes bundled product revenue for ourillumigene®molecular test system. The bundled product includes an instrument, instrument accessories and test kits. If not sold outright, amounts invoiced for theillumigene®test kits cover the instrument, accessories and test kits. Revenue is recognized based on kit sales. If not sold outright, costs for the instruments are recognized in cost of sales over the period that we have a pricing agreement in effect with the customer, generally three years.

Life Science revenue for contract services may come from research and development services or manufacturing services, including process development work, or a combination of both. Revenue is recognized based on each of the deliverables in a given arrangement having distinct and separate customer pricing. Pricing is often subject to a competitive bidding process. Contract research and development services may be performed on a “time and materials” basis or “fixed fee” basis. For “time and materials” arrangements, revenue is recognized as services are performed and billed. For “fixed fee” arrangements, revenue is recognized upon completion and acceptance by the customer. For contract manufacturing services, revenue is generally recognized upon delivery of product and acceptance by the customer. In some cases, customers may request that we store on their behalf, clinical grade biologicals that we produce under contract manufacturing agreements. These cases arise when customers do not have clinical grade storage facilities or do not want to risk contamination during transport. For such cases, revenue may be recognized on a bill-and-hold basis. No such bill-and-hold arrangements existed at December 31, 2011 or September 30, 2011.

 

Page 6


Trade accounts receivable are recorded in the accompanying Condensed Consolidated Balance Sheets at invoiced amounts less provisions for rebates and doubtful accounts. The allowance for doubtful accounts represents our estimate of probable credit losses and is based on historical write-off experience. The allowance for doubtful accounts and related metrics, such as days’ sales outstanding, are reviewed monthly. Accounts with past due balances over 90 days are reviewed individually for collectibility. Customer invoices are charged off against the allowance when we believe it is probable that the invoices will not be paid.
(b)
Comprehensive Income (Loss) —
Our comprehensive income or loss is comprised of net earnings, foreign currency translation and the related income tax effects.
Assets and liabilities of foreign operations are translated using period-end exchange rates with gains or losses resulting from translation included as a separate component of comprehensive income or loss. Revenues and expenses are translated using exchange rates prevailing during the period. We also recognize foreign currency transaction gains and losses on certain assets and liabilities that are denominated in the Australian dollar, British pound and Euro currencies. These gains and losses are included in other income and expense in the accompanying Condensed Consolidated Statements of Operations.
Comprehensive income for the interim periods was as follows:
                 
  Three Months  Nine Months 
  Ended June 30,  Ended June 30, 
  2011  2010  2011  2010 
                 
Net earnings $6,836  $6,424  $20,121  $21,325 
Foreign currency translation adjustment  335   (1,287)  1,203   (2,429)
Income taxes  (117)  451   (421)  850 
             
Comprehensive income $7,054  $5,588  $20,903  $19,746 
             
(c)
Income Taxes —
The provision for income taxes includes federal, foreign, state and local income taxes currently payable and those deferred because of temporary differences between income for financial reporting and income for tax purposes. We prepare estimates of permanent and temporary differences between income for financial reporting purposes and income for tax purposes. These differences are adjusted to actual upon filing of our tax returns, typically occurring in the third and fourth quarters of the current fiscal year for the preceding fiscal year’s estimates.
We account for uncertain tax positions using a benefit recognition model with a two-step approach: (i) a more-likely-than-not recognition criterion; and (ii) a measurement attribute that measures the position as the largest amount of tax benefit that is greater than 50% likely of being realized upon ultimate settlement. If it is not more likely than not that the benefit will be sustained on its technical merits, no benefit is recorded. We recognize accrued interest and penalties related to unrecognized tax benefits as a portion of our income tax provision in the Condensed Consolidated Statements of Operations.
(d)
Stock-based Compensation —
We recognize compensation expense for all stock-based awards made to employees, based upon the fair value of the stock-based award on the date of the grant. Shares are expensed over their requisite service period.

Page 7


(e)
Cash, Cash Equivalents and Investments —
Our investment portfolio includes the following components:
                 
  June 30, 2011  September 30, 2010 
  Cash and      Cash and    
  Equivalents  Other  Equivalents  Other 
Taxable investments -                
Overnight repurchase agreements $11,332  $  $14,862  $ 
Money market funds        10,249    
Cash on hand -                
Restricted     1,000      1,000 
Unrestricted  14,231      12,768    
             
Total $25,563  $1,000  $37,879  $1,000 
             
(f)
Recent Accounting Pronouncements —
In May 2011, FASB issued Accounting Standards Update (ASU) No. 2011-04,Amendments to Achieve Common Fair Value Measurement and Disclosure Requirements in U.S. GAAP and IFRSs. FASB ASU No. 2011-04 amends and clarifies the measurement and disclosure requirements of FASB ASC 820, resulting in common requirements for measuring fair value and for disclosing information about fair value measurements, clarification of how to apply existing fair value measurement and disclosure requirements, and changes to certain principles and requirements for measuring fair value and disclosing information about fair value measurements. The new requirements are effective for fiscal years beginning after December 15, 2011. The Company plans to adopt this amended guidance on October 1, 2012 and at this time does not anticipate that it will have a material impact on the Company’s consolidated results of operations, cash flows or financial position.
In June 2011, FASB issued ASU No. 2011-05,Presentation of Comprehensive Income, which amends the disclosure and presentation requirements of Comprehensive Income. Specifically, FASB ASU No. 2011-05 requires that all nonowner changes in shareholders’ equity be presented either in 1) a single continuous statement of comprehensive income or 2) two separate but consecutive statements, in which the first statement presents total net income and its components, and the second statement presents total other comprehensive income and its components. These new presentation requirements are effective for the Company beginning October 1, 2012, with early adoption permitted. The Company will proceed with evaluating the presentation alternatives provided within FASB ASU No. 2011-05, as well as the permitted dates of adoption, and determine the most appropriate changes to be made to the current presentation of comprehensive income within its Statement of Changes in Shareholders’ Equity and when to make such changes.
(g)
Reclassifications —
Certain reclassifications have been made to the prior period financial statements to conform to the current fiscal period presentation. Such reclassifications had no impact on net earnings or shareholders’ equity.
3. Acquisition of Bioline Group
On July 20, 2010, we acquired all of the outstanding common stock of the Bioline group of companies (collectively the “Bioline Group”). We paid $23,849 from cash and equivalents on hand to acquire the Bioline Group. Headquartered in London, England, the Bioline Group is a leading manufacturer and distributor of molecular biology reagents with additional operations in Germany, Australia and the United States. The highly specialized molecular biology reagents it supplies to the life science research, biotech, pharmaceutical and commercial diagnostics markets are the critical components used in PCR testing for DNA, RNA and other genomic testing.

Page 8


As a result of the consideration paid exceeding the fair value of the net assets being acquired, goodwill in the amount of $12,992 was recorded in connection with this acquisition, none of which will be deductible for tax purposes. This goodwill results largely from the addition of key global operations and direct sales capabilities, management talent and a research-oriented customer base, to complement our existing Life Science operations. In addition to the Bioline Group’s results of operations, which are included in our Condensed Consolidated Statements of Operations for the three and nine months ended June 30, 2011 and reported as part of the Life Science operating segment, the consolidated results for the three and nine months ended June 30, 2011 also include:
i)$0 and $587 of Cost of Sales for the three and nine months, respectively, related to the roll-out of fair value inventory adjustments for sales of products that were in the Bioline Group’s inventory on the date of acquisition and, therefore, were valued at fair value, rather than manufactured cost, in the opening balance sheet; and
ii)$260 and $767 of General and Administrative Expenses for the three and nine months, respectively, related to the amortization of specific identifiable intangible assets recorded on the opening balance sheet, including customer relationships, license agreements, non-compete agreements, manufacturing processes and trade names.
The results of the Bioline Group included in the consolidated results of the Company for the three and nine months ended June 30, 2011 are as follows, reflecting the items noted above and adjustments to the Group’s income tax provision during the three months ended June 30, 2011:
         
  Three  Nine 
  Months  Months 
  Ended  Ended 
  June 30, 2011  June 30, 2011 
Net Sales $3,905  $10,966 
Operating Income (Loss) $83  $(91)
Net (Loss) Earnings $(31) $28 
       
The recognized amounts of identifiable assets acquired and liabilities assumed in the acquisition of the Bioline Group are as follows:
             
  July 20,       
  2010  Measurement  July 20, 
  (as initially  Period  2010 
  reported)  Adjustments  (as adjusted) 
Fair value of assets acquired -            
Cash and equivalents $3,445      $3,445 
Accounts receivable  1,897       1,897 
Inventories  2,807       2,807 
Other current assets  371  $(21)  350 
Property, plant and equipment, net  816       816 
Goodwill  13,166   (174)  12,992 
Other intangible assets (estimated useful life):            
Customer relationships (10 years)  3,898       3,898 
Manufacturing processes (6 years)  1,467       1,467 
License agreements (approx. 8 year wtd. avg.)  718       718 
Non-compete agreements (1 year)  122       122 
Trade names (10 years)  995       995 
          
   29,702   (195)  29,507 
Fair value of liabilities assumed -            
Accounts payable and accrued expenses  2,817   364   3,181 
Deferred income tax liabilities  3,036   (559)  2,477 
          
Total consideration paid $23,849  $  $23,849 
          

Page 9


As of June 30, 2011, the purchase price allocation related to the acquisition of the Bioline Group has been finalized and is reflected in the above fair values of the assets acquired and liabilities assumed. These fair values are based on the information that was available as of the acquisition date and the subsequent filing of this Form 10-Q and are reflected in the accompanying Condensed Consolidated Balance Sheets including retrospective adjustmentat invoiced amounts less provisions for rebates and doubtful accounts. The allowance for doubtful accounts represents our estimate of probable credit losses and is based on current trends and historical write-off experience. The allowance for doubtful accounts and related metrics, such as days’ sales outstanding, are reviewed monthly. Accounts with past due balances over 90 days are reviewed individually for collectibility. Customer invoices are charged off against the allowance when we believe it is probable that the invoices will not be paid. Approximately $4,900 of our accounts receivable at December 31, 2011 is due from Italian hospital customers whose funding ultimately comes from the Italian government. The magnitude of the September 30, 2010sovereign debt crisis in Europe, and Italy in particular, is significant. We have experienced a deterioration in the aging of our Italian accounts receivable and continue to monitor the situation closely.

(b)

Comprehensive Income (Loss) –

Our comprehensive income or loss is comprised of net earnings, foreign currency translation and the related income tax effects.

Assets and liabilities of foreign operations are translated using period-end exchange rates with gains or losses resulting from translation included as a separate component of comprehensive income or loss. Revenues and expenses are translated using exchange rates prevailing during the period. We also recognize foreign currency transaction gains and losses on certain assets and liabilities that are denominated in the Australian dollar, British pound and Euro currencies. These gains and losses are included in other income and expense in the accompanying Condensed Consolidated Balance Sheet.

Statements of Operations.

Comprehensive income for the interim periods was as follows:

September 30,September 30,
     Three Months 
    Ended December 31, 
     2011   2010 

Net earnings

    $6,578   $6,025 

Foreign currency translation adjustment

     (1,044   (936

Income taxes

     363    325 
    

 

 

   

 

 

 

Comprehensive income

    $5,897   $5,414 
    

 

 

   

 

 

 

(c)

Income Taxes –

The consolidated pro forma resultsprovision for income taxes includes federal, foreign, state and local income taxes currently payable and those deferred because of temporary differences between income for financial reporting and income for tax purposes. We prepare estimates of permanent and temporary differences between income for financial reporting purposes and income for tax purposes. These differences are adjusted to actual upon filing of our tax returns, typically occurring in the third and fourth quarters of the combined entities of Meridian and the Bioline Group, had the acquisition date been October 1, 2009, are as followscurrent fiscal year for the periods indicated:

                 
  Three Months  Nine Months 
  Ended June 30,  Ended June 30, 
  2011  2010  2011  2010 
   
Net Sales $40,052  $37,361  $118,374  $117,208 
Net Earnings $6,857  $7,201  $20,565  $20,757 
Diluted Earnings Per Common Share $0.17  $0.17  $0.50  $0.50 
             
These pro forma amounts have been calculated after adjustingpreceding fiscal year’s estimates.

We account for uncertain tax positions using a benefit recognition model with a two-step approach: (i) a more-likely-than-not recognition criterion; and (ii) a measurement attribute that measures the resultsposition as the largest amount of tax benefit that is greater than 50% likely of being realized upon ultimate settlement. If it is not more likely than not that the Bioline Group to reflect the transaction costs incurred by the Companybenefit will be sustained on its technical merits, no benefit is recorded. We recognize accrued interest and the additional amortization that would have been charged assuming the previously-discussed fair value adjustments to inventory and identifiable intangible assets had been applied on October 1, 2009, together with the consequential tax effects. Fiscal 2011 pro forma earnings exclude $21 and $444 for the three and nine month periods, respectively,penalties related to amortizationunrecognized tax benefits as a portion of our income tax provision in the Condensed Consolidated Statements of Operations.

(d)

Stock-based Compensation –

We recognize compensation expense for all share-based awards made to employees, based upon the fair value adjustments to inventoryof the share-based award on the date of the grant. Shares are expensed over their requisite service period.

7


(e)

Cash and Cash Equivalents –

Cash and identifiable intangible assets andcash equivalents include the related tax effects, as these amountsfollowing components:

September 30,September 30,September 30,September 30,
     December 31, 2011     September 30, 2011 
     Cash and
Equivalents
     Other     Cash and
Equivalents
     Other 

Overnight repurchase agreements

    $14,927     $—        $11,784     $—    

Cash on hand—

                

Restricted

     —         1,000      —         1,000 

Unrestricted

     11,278      —         11,842      —    
    

 

 

     

 

 

     

 

 

     

 

 

 

Total

    $26,205     $1,000     $23,626     $1,000 
    

 

 

     

 

 

     

 

 

     

 

 

 

(f)

Reclassifications –

Certain reclassifications have been included inmade to the prior period financial statements to conform to the current fiscal 2010 pro forma earnings.

period presentation. Such reclassifications had no impact on net earnings or shareholders’ equity.

3.

4. Inventories

Inventories are comprised of the following:

         
  June 30,  September 30, 
  2011  2010 
Raw materials $6,821  $6,221 
Work-in-process  7,655   6,784 
Finished goods — illumigene instruments  3,556   455 
Finished goods — kits and other  17,443   16,090 
       
Gross inventory  35,475   29,550 
Less: Reserves  (1,409)  (1,130)
       
Net inventory $34,066  $28,420 
       

September 30,September 30,
     December 31,
2011
     September 30,
2011
 

Raw materials

    $7,940     $7,272 

Work-in-process

     7,593      7,016 

Finished goods - illumigene instruments

     3,599      4,179 

Finished goods - kits and other

     14,524      14,222 
    

 

 

     

 

 

 

Total

    $33,656     $32,689 
    

 

 

     

 

 

 

4.

5. Major Customers and Segment Information

Meridian was formed in 1976 and functions as a fully-integrated research, development, manufacturing, marketing and sales organization with primary emphasis in the fieldfields of in vitro diagnostics and life science. Our principal businesses are (i) the development, manufacture and distribution of diagnostic test kits primarily for gastrointestinal, viral, respiratory and parasitic infectious diseases; (ii) the manufacture and distribution of bulk antigens, antibodies, PCR/qPCR reagents, nucleotides, competent cells and bioresearch reagents used by researchers and other diagnostic manufacturers; and (iii) the contract development and manufacture of proteins and other biologicals for use by biopharmaceutical and biotechnology companies engaged in research for new drugs and vaccines.

Our reportable operating segments are U.S. Diagnostics, European Diagnostics and Life Science. Initial segmentation between Diagnostics and Life Science has been determined based upon products and customers, with further segmentation of Diagnostics between U.S. and European being based upon geographic regions served and management responsibility. The U.S. Diagnostics operating segment consists of manufacturing operations in Cincinnati, Ohio, and the sale and distribution of diagnostic test kits in the U.S. and countries outside of Australia, Europe, Africa and the Middle East. The European Diagnostics operating segment consists of the sale and distribution of diagnostic test kits in Australia, Europe, Africa and the Middle East. The Life Science operating segment consists of manufacturing operations in Memphis, Tennessee; Saco, Maine; Boca Raton, Florida; London, England; Luckenwalde, Germany; and Sydney, Australia, and the sale and distribution of bulk antigens, antibodies, PCR/qPCR reagents, nucleotides, competent cells and bioresearch reagents domestically and abroad. During the fourth quarter of fiscal 2011, plans were announced to consolidate the Saco, Maine operations into the Memphis, Tennessee facility, with such consolidation commencing early in the fiscal 2012 first quarter and expected to be completed in the third quarter of fiscal 2012. During the

8


first quarter of fiscal 2012, the Company incurred $444 of costs associated with the facility consolidation, primarily related to employee retention, resulting in $1,501 of total costs incurred since announcement of the consolidation in the fourth quarter of fiscal 2011 ($509 in Cost of Sales and $992 in Operating Expenses). Additional costs related to the consolidation totaling approximately $500 are expected to be incurred during the remainder of fiscal 2012, with the majority of such costs to be incurred in connection with retention bonus and other employee-related costs. The Life Science operating segment also includes the contract development and manufacture of cGMP clinical grade proteins and other biologicals for use by biopharmaceutical and biotechnology companies engaged in research for new drugs and vaccines.

Page 10


Two distributor customers accounted for 47%50% and 52% of the U.S. Diagnostics operating segment third-party sales during the three months ended June 30, 2011 and 2010, respectively, and 50% and 58% during the nine months ended June 30,December 31, 2011 and 2010, respectively. This lower percentage of sales reflects the fact that the majority of ourillumigene® product sales are direct, as well as the comparative decline in the distributors’ inventory stocking of influenza and other products. ThreeTwo customers accounted for 17%27% and 29%16% of the Life Science operating segment third-party sales during the three months ended June 30,December 31, 2011 and 2010, respectively, and 18% and 33% during the nine months ended June 30, 2011 and 2010, respectively, primarily reflecting the addition of the Bioline Group.
respectively.

Segment information for the interim periods is as follows:

                     
  U.S.  European  Life       
  Diagnostics  Diagnostics  Science  Eliminations(1)  Total 
Three Months Ended June 30, 2011
                    
Net sales -                    
Third-party $23,829  $6,612  $9,611  $  $40,052 
Inter-segment  2,875   9   141   (3,025)   
Operating income  8,399   978   797   (43)  10,131 
Goodwill (June 30, 2011)  1,381      22,062      23,443 
Other intangible assets, net (June 30, 2011)  1,741      9,891      11,632 
Total assets (June 30, 2011)  71,831   20,680   94,164   (28,724)  157,951 
                
                     
Three Months Ended June 30, 2010
                    
Net sales -                    
Third-party $21,121  $6,218  $6,518  $  $33,857 
Inter-segment  2,723   8   177   (2,908)   
Operating income  8,104   726   752   194   9,776 
Goodwill (September 30, 2010)  1,381      21,921      23,302 
Other intangible assets, net (September 30, 2010)  2,283   9   11,035      13,327 
Total assets (September 30, 2010)  72,030   18,044   90,388   (25,821)  154,641 
                
                     
Nine Months Ended June 30, 2011
                    
Net sales -                    
Third-party $72,007  $18,926  $27,441  $  $118,374 
Inter-segment  7,938   16   459   (8,413)   
Operating income  26,780   1,781   1,499   123   30,183 
                
                     
Nine Months Ended June 30, 2010
                    
Net sales -                    
Third-party $70,018  $19,103  $18,340  $  $107,461 
Inter-segment  8,200   12   438   (8,650)   
Operating income  26,805   2,789   2,976   87   32,657 
                

September 30,September 30,September 30,September 30,September 30,
     U.S.
Diagnostics
     European
Diagnostics
     Life Science   Eliminations(1)   Total 

Three Months Ended December 31, 2011

  

Net sales—

                

Third-party

    $25,200     $5,505     $9,561   $—      $40,266 

Inter-segment

     2,228      —         336    (2,564   —    

Operating income (2)

     8,165      951      698    (9   9,805 

Goodwill (December 31, 2011)

     1,381      —         21,318    —       22,699 

Other intangible assets, net (December 31, 2011)

     2,746      —         8,902    —       11,648 

Total assets (December 31, 2011)

     80,452      15,124      93,409    (33,790   155,195 

Three Months Ended December 31, 2010

                

Net sales—

                

Third-party

    $22,650     $5,929     $8,684   $—      $37,263 

Inter-segment

     2,608      4      213    (2,825   —    

Operating income

     8,574      753      (221   (16   9,090 

Goodwill (September 30, 2011)

     1,381      —         21,743    —       23,124 

Other intangible assets, net (September 30, 2011)

     1,604      —         9,343    —       10,947 

Total assets (September 30, 2011)

     73,850      19,390      92,467    (30,214   155,493 

(1)

Eliminations consist of inter-segment transactions.

(2)

Life Science includes $444 of costs related to consolidation of the Maine operations into the Tennessee facility.

Transactions between operating segments are accounted for at established intercompany prices for internal and management purposes, with all intercompany amounts eliminated in consolidation.

 

Page 11

9


5.

6. Intangible Assets

A summary of our acquired intangible assets subject to amortization, as of June 30,December 31, 2011 and September 30, 20102011 is as follows:

                 
  June 30, 2011  September 30, 2010 
  Gross      Gross    
  Carrying  Accumulated  Carrying  Accumulated 
  Value  Amortization  Value  Amortization 
                 
Manufacturing technologies, core products and cell lines $11,664  $8,360  $11,644  $7,693 
Trademarks, licenses and patents  3,654   1,329   3,547   997 
Customer lists and supply agreements  12,322   6,330   12,537   5,816 
Non-compete agreements  128   117   126   21 
             
  $27,768  $16,136  $27,854  $14,527 
             

September 30,September 30,September 30,September 30,
     December 31, 2011     September 30, 2011 
     Gross
Carrying
Value
     Accumulated
Amortization
     Gross
Carrying
Value
     Accumulated
Amortization
 

Manufacturing technologies, core products and cell lines

    $11,610     $8,732     $11,626     $8,545 

Trademarks, licenses and patents

     4,809      1,429      3,538      1,337 

Customer lists and supply agreements

     12,178      6,788      12,222      6,557 
    

 

 

     

 

 

     

 

 

     

 

 

 
    $28,597     $16,949     $27,386     $16,439 
    

 

 

     

 

 

     

 

 

     

 

 

 

The actual aggregate amortization expense for these intangible assets was $570$520 and $345$595 for the three months ended June 30, 2011 and 2010, respectively, and $1,796 and $1,079 for the nine months ended June 30,December 31, 2011 and 2010, respectively. The estimated aggregate amortization expense for these intangible assets for each of the fiscal years through fiscal 20152016 is as follows: fiscal 2011 — $2,336, fiscal 2012 — $2,079,– $2,154, fiscal 2013 — $2,078,– $2,175, fiscal 2014 — $1,641– $1,739, fiscal 2015 – $1,492 and fiscal 2015 — $1,392.

7. Fair Value Measurements
We use fair value measurements to value our financial assets and liabilities. Fair value is the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. Fair value hierarchy prioritizes inputs to valuation techniques used to measure fair value into three broad levels, which are described below:
Level 1: Quoted prices (unadjusted) in active markets for identical assets or liabilities that are accessible at the measurement date for assets and liabilities. The fair value hierarchy gives the highest priority to Level 1 inputs.
Level 2: Inputs other than quoted prices included within Level 1 that are observable for the assets or liabilities, either directly or indirectly. These include quoted prices for identical or similar assets or liabilities in markets that are not active, that is, markets in which there are few transactions for the asset or liability, the prices are not current, or price quotations vary substantially either over time or among market makers, or in which little information is released publicly and inputs that are derived principally from or corroborated by observable market data by correlation or other means.
Level 3: Unobservable inputs, developed using our estimates and assumptions, which reflect those that the market participants would use. Such inputs are used when little or no market data is available. The fair value hierarchy gives the lowest priority to Level 3 inputs.
Determining where an asset or liability falls within the hierarchy depends on the lowest level input that is significant to the fair value measurement as a whole. In determining fair value, we utilize valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible and we consider counterparty credit risk in the assessment of fair value.
We had no financial assets or liabilities carried at fair value at June 30, 2011 to be classified as Level 1, 2 or 3. As of September 30, 2010, financial assets and liabilities to be so classified were comprised solely of money market funds totaling $10,249 classified as Level 1, with no financial assets or liabilities classified as Level 2 or Level 3.
2016 – $1,150.

 

Page 12


ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
ITEM 2.MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

Refer to “Forward Looking Statements” following the Index in front of this Form 10-Q. In the discussion that follows, all amounts are in thousands (both tables and text), except per share data and percentages.

Following is a discussion and analysis of the financial statements and other statistical data that management believes will enhance the understanding of Meridian’s financial condition, changes in financial condition and results of operations. This discussion should be read in conjunction with the financial statements and notes thereto beginning on page 1.

Results of Operations

Three Months Ended June 30, 2011

Net earnings for the thirdfirst quarter of fiscal 20112012 increased 6%9% to $6,836,$6,578, or $0.17$0.16 per diluted share, from net earnings for the thirdfirst quarter of fiscal 20102011 of $6,424,$6,025, or $0.16$0.15 per diluted share. This increase reflects the combined effects of both increased sales and slightly increased operating expenses, resulting primarily fromexpenses.Additionally, fiscal 2012 includes $444 of costs associated with the inclusionconsolidation of the Bioline Group, which was acquired in July 2010.Saco, Maine operations into the Memphis, Tennessee facility (impact on earnings $289, or $0.01 per diluted share). Consolidated sales increased 18%8% to $40,052$40,266 for the thirdfirst quarter of fiscal 20112012 compared to the same period of the prior year, reflecting the impact of Bioline Group sales and increases in sales across all four of our diagnostic focus product families:C. difficile, Foodborne andH. pylori, and Upper Respiratory.

our Life Science businesses.

Sales for the U.S. Diagnostics operating segment for the thirdfirst quarter of fiscal 2012 increased 11% compared to the first quarter of fiscal 2011, increased 13% compared to the third quarter of fiscal 2010, reflecting growth across all four of our focus product families — ranging from 8%– 6% growth in ourH. pyloriproducts, to 26%25% growth in our foodborne products and 37% growth in ourC. difficileproducts. ThirdFirst quarter 20112012 sales for our European Diagnostics operating segment increased 6%decreased 7% compared to the third quarter of fiscal 2010 due primarily to a positive currency effect. As a result of the Bioline Group acquisition, our Life Science segment experienced a 47% increase in sales during this period. Excluding the effect of the Bioline Group, sales of our core Life Science operating segment decreased by 12% during the third quarter of fiscal 2011 compared to the third quarter of fiscal 2010, as this business continues to experience both pricing pressure and reduced order volumes in bulk antigens, antibodies and reagents. We expect core Life Science revenues to be flat to down single digits for fiscal 2012 as our large diagnostic manufacturing customers exert pricing pressures throughout their supply chains and certain segments of the diagnostics industry migrate to molecular technologies.

Nine Months Ended June 30, 2011
For the nine month period ended June 30, 2011, net earnings decreased 6% to $20,121, or $0.49 per diluted share, from net earnings for the comparable fiscal 2010 period of $21,325, or $0.52 per diluted share. This decrease reflects the impact of the increase in total sales being more than offset by the increase in operating expenses that resulted primarily from the inclusion of expenses from the Bioline Group, acquired in July 2010, as well as costs related to the reorganization of our European and global sales and marketing leadership during the secondfirst quarter of fiscal 2011. Consolidated sales increased 10% to $118,374 for the first nine months of fiscal 2011 compared to the same period of the prior fiscal year. This increase primarily results from the impact of Bioline Group sales and strong growth in foodborne andH. pyloriproduct sales being partially offset by a 32% decrease in respiratory product sales and a decline in sales of our core Life Science operating segment.
For the nine month period ended June 30, 2011, the Bioline Group has contributed nearly $11,000 in sales, with a slight operating loss fromOn an organic basis, which excludes the effects of selling through acquisition date inventory. The Bioline Group has contributed positive operating income for each of the past two fiscal quarters.
During the first nine months of fiscal 2011,currency translation, sales for the U.S. Diagnostics operating segment increased 3% from the comparable fiscal 2010 period. This modest increase reflects sales growth in ourC. difficile,foodborne andH. pyloriproduct families being significantly offset by the decrease in respiratory product sales, which resulted from the dramatic impact on the fiscal 2010 first quarter of the novel A (H1N1) influenza outbreak and the abrupt halt of the outbreak in December 2009. Sales of our European Diagnostics operating segment fordecreased 6% during the first nine monthsquarter. The decrease in this operating segment reflects the general economic conditions in the European market, including the sovereign debt crisis, and the resulting reduction in medical-related funding in certain locations, compounded by the ongoing effects of fiscal 2011 decreased 1% compared to the first nine months of fiscal 2010 largely due to decreased salessignificant competitive pressures in theC. difficileand respiratoryH. pylori product families. As a result of the Bioline Group acquisition, our Life Science segment experienced a 50% increaseReflecting growth in sales during this period. Excluding the effect of the Bioline Group,both its viral antigen and molecular reagent businesses, sales of our core Life Science operating segment decreasedincreased by 10% during the first nine monthsquarter of fiscal 20112012 compared to the first nine monthsquarter of fiscal 2010, as this business continues to experience both pricing pressure and reduced order volumes in several key product lines.
2011.

 

Page 13

10


Non-GAAP Information

The tables below provide information on net earnings, basic earnings per share and diluted earnings per share, excluding the effect of costs associated with reorganizingconsolidation of our European and Global Sales & Marketing Leadership, each ofSaco, Maine operations into our Memphis, Tennessee facility, which is a non-GAAP financial measure, as well as reconciliations to amounts reported under U.S. Generally Accepted Accounting Principles. We believe that this information is useful to those who read our financial statements and evaluate our operating results because:

 1.

These measures help to appropriately evaluate and compare the results of operations from period to period by removing the impact of non-routine costs related to reorganizing our Europeanconsolidating the Maine operations; and Global Sales and Marketing Leadership; and

 2.

These measures are used by our management for various purposes, including evaluating performance against incentive bonus achievement targets, comparing performance from period to period in presentations to our Board of Directors, and as a basis for strategic planning and forecasting.

     
  Nine Months 
  Ended June 30, 
  2011 
Net Earnings -    
U.S. GAAP basis $20,121 
European and Global Sales & Marketing Leadership Reorganization costs, inclusive of the income tax effect (1)  872 
    
Adjusted earnings $20,993 
    
     
Net Earnings per Basic Common Share -    
U.S. GAAP basis $0.49 
European and Global Sales & Marketing Leadership Reorganization costs, inclusive of the income tax effect (1)  0.02 
    
Adjusted Basic EPS (2) $0.52 
    
     
Net Earnings per Diluted Common Share -    
U.S. GAAP basis $0.49 
European and Global Sales & Marketing Leadership Reorganization costs, inclusive of the income tax effect (1)  0.02 
    
Adjusted Diluted EPS $0.51 
    

September 30,
     Three Months
Ended
December 31,
2011
 

Net Earnings -

    

U.S. GAAP basis

    $6,578 

Facility consolidation costs (1)

     289 
    

 

 

 

Adjusted earnings

    $6,867 
    

 

 

 

Net Earnings per Basic Common Share -

    

U.S. GAAP basis

    $0.16 

Facility consolidation costs (1)

     0.01 
    

 

 

 

Adjusted Basic EPS

    $0.17 
    

 

 

 

Net Earnings per Diluted Common Share -

    

U.S. GAAP basis

    $0.16 

Facility consolidation costs (1)

     0.01 
    

 

 

 

Adjusted Diluted EPS

    $0.17 
    

 

 

 

(1)

The income tax effects of the Leadership Reorganizationfacility consolidation costs totaled $368$155 and were calculated using the effective tax rates of the jurisdictions in which the costs were incurred.

(2)Net Earnings per Basic Common Share for the nine months ended June 30, 2011 does not sum to the total due to rounding.

Page 14


Revenue Overview

Our Diagnostics operating segments provide the largest share of our consolidated revenues, 76% and 81%77% for the thirdfirst quarters of fiscal 2012 and 2011, and 2010, respectively, and 77% and 83% for the first nine months of fiscal 2011 and 2010, respectively. The percentage declines in both the quarterly and fiscal year-to-date periods result primarily from the addition of the Bioline Group to our Life Science operating segment and, in the case of year-to-date comparisons, the impact of the novel A (H1N1) influenza outbreak in 2010. Sales from our four focus families (C. difficile, Foodborne andH. pylori) comprised 62% and Upper Respiratory) comprised 71% and 69%56% of our Diagnostics operating segments’ revenues during the thirdfirst quarters of fiscal 2012 and 2011, and 2010, respectively, and 71% and 73% for the nine month periods ended June 30, 2011 and 2010, respectively.

Overall revenue change for the fiscal 2011 third2012 first quarter for both of our Diagnostics operating segments combined was an increase of 11%increased 7%, reflecting growth across all four of our focus product families. The levels offamilies – 2% growth in the focus products ranged from 7% in ourH. pyloriproducts, to 28%24% growth in our foodborne products.products and 27% growth in ourC. difficile products, which have experienced steady quarter-over-quarter increases since declining 3% in the first quarter of 2011. Respiratory product sales, including influenza respiratory products, decreased 2%. On an organic basis, which excludes the effects of currency translation, sales for our European Diagnostics operating segment decreased by 6% during the thirdfirst quarter, reflecting the combined effects of decreases in ourC. difficile,upper respiratory andH. pyloriproduct families, partially offset by growth in our foodborne product sales.

For The overall decrease in the first nine monthssales of fiscal 2011, revenue for boththis operating segment reflects the general economic conditions in the European market, including the sovereign debt crisis, and the resulting reduction in medical-related funding in certain locations, compounded by the ongoing effects of our Diagnostics operating segments combined increased 2% fromsignificant competitive pressures in the comparable fiscal 2010 period. This slight increase primarily results from sales growth in ourC. difficile andH. pylori product families.

11


C. difficile H. pyloriProducts

Ourillumigene® molecularC. difficile product has now been available in markets around the world for over 15 months. Sales of this product were approximately $4,500 and foodborne product families being significantly offset by the effects on our respiratory product sales of a relatively mild worldwide flu season$775 in the first quarter of fiscal 2012 and 2011, compared to the fiscal 2010 first quarter, including the dramatic effects on the prior year of the world-wide outbreak of novel A (H1N1) influenza. Excluding the effects of currency translation, our European Diagnostics operating segment’s sales during the nine months ended June 30, 2011 decreased 2% relative to the comparable fiscal 2010 period, reflecting the combined effects of decreases in ourC. difficile,upper respiratory andH. pyloriproduct families, partially offset by growth in our foodborne product sales.

C. difficile Products
During the third quarter of fiscal 2010, we launched ourillumigene® molecularC. difficileproduct in non-U.S. markets, with launch of the product into U.S. markets following in the fourth quarter of fiscal 2010, upon receiving FDA clearance. As a result, werespectively. We have nearly 500750 placements ofillumigene® units worldwide to date, with approximately 90%85% of these installed in the U.S. Of the total units placed worldwide, we estimate that more than 450 will be used for reporting of clinical results, with the balance being used for evaluations and third party studies. At the present time, it generally takes a customer 90 days on average, from purchase order placement to begin routine test usage. Webecome revenue producing – a timeframe we are continually working to reduce that time frame. We expectreduce. Ourillumigene® molecularC. difficile product has restored theC. difficile product family to positive sales of the product, which totaled approximately $2,800 and $5,600growth, 27% in the three and nine months ended June 30, 2011, respectively, to continue to grow significantly throughout the balancefirst quarter of fiscal 20112012, and during fiscal 2012, although no assurances can be madehas allowed us to begin to recover lost test volume from our Toxin products.

Our major competitors in this regard.

As a result of competitive pressures in this diseaseproduct family over the last several years from new competitive products, including molecular assays, in recent previous periodsare Cepheid and Becton Dickinson. We believe that we have experienced extremely slow growth intwo principal advantages versus our competition. First, our instrumentation package has a smaller footprint and significantly lower cost than either Cepheid or Becton Dickinson. We believe that this advantage allows our product to fit into virtually any size hospital or reference laboratory. We believe that our second principal advantage is the salesbreadth of ourC. difficileproducts. However, due to the introduction of ourillumigene® molecularC. difficileproduct and its growing market acceptance, we have begun to see a marked improvement over the recent periods. Sales of ourC. difficileproduct grew 13% for all of our Diagnostics operating segments during the third quarter of fiscal 2011 and 5% for the first nine months of fiscal 2011.
offerings. With the launch of our molecular product and recent FDA clearance and submission activities related toof our common antigenC. difficileproducts PremierC. difficileGDH received FDA clearance in May 2011, and ImmuoImmunoCard C. difficileGDH was submitted to thereceived FDA clearance in mid-July — we believeDecember 2011 – unlike our primary competitors, we are in a unique position to offer a full line of testing solutions to our clinical laboratory customers around the world to counter the competitive pressures surrounding this market. Additionally, we hold the only FDA-approved claim forC. difficiletesting in the pediatric population. During July,December 2011, we submitted to thereceived FDA clearance for our second molecular test for theillumigene® molecular platform,illumigene® Group BStreptococcus(GBS), and over the next 12 months, we expect twothe following additional tests for the platform — tests for Group AStreptococcusand,Mycoplasma pneumoniae andBordetella pertussis/parapertussis to clear formal clinical trials and be submitted to the FDA for marketing clearance.

Page 15


Foodborne Products

Increased demand for our foodborne illness testing products throughout the first nine months of fiscal 2011has resulted in our U.S. Diagnostics operating segment experiencing sales increases for these products totaling 26% and 40%25% for the three and nine month periods ended June 30, 2011, respectively.first quarter of fiscal 2012. During thesethis same periods,period, our European Diagnostics operating segment experienced a 9% increase in sales increases of approximately 60% and 43%, respectively,these products on an organic basis, reflecting the effects of theEnterohemorrhagic E. coli(EHEC) infection outbreak in Europe during the quarter.

basis.

H. pylori Products

During the thirdfirst quarter of fiscal 2011,2012, sales of ourH. pyloriproducts grew 8%6% for our U.S. Diagnostics operating segment; 14% duringsegment. We have seen healthy customer orders in January, confirming our growth in the nine month fiscal year-to-date period. Thisfirst quarter was impacted by order patterns from one regional reference laboratory. The increase in our U.S. Diagnostics operating segment continues to reflect the benefits of our partnerships with managed care companies in promoting the health and economic benefits of a test and treat strategy, and the ongoing effects of such strategy moving physician behavior away from serology-based testing toward direct antigen testing. Due to significant competitive pressures related to these products on the international front, sales ofH. pyloriproducts for our European Diagnostics operating segment declined 7%6% on an organic basis for the fiscal 2011 third2012 first quarter, compared to the thirdfirst quarter of fiscal 2010, and declined 2% during the year-over-year nine month periods ended June 30.

2011.

Upper Respiratory Products

During the three and nine month periods ended June 30, 2011, upperfirst quarter of fiscal 2012, respiratory product sales, including influenza related products, for our Diagnostics operating segments increased 8%decreased 2%. This decline reflects a 1% decline domestically and decreased 32%, respectively, relative to the comparable fiscal 2010 periods. The sales decrease in the comparable year-to-date periods is a direct result of influenza test kit sales; in particular the abrupt halt, in December 2009, of the outbreak of the novel A (H1N1) influenza virus that began to spread across the northern hemisphere during the second half of fiscal 2009. The outbreak also created an increased interest in influenza testing in European markets where rapid testing has not been traditionally performed and resulted in significant sales activity for these products during the fiscal 2010 first quarter. However, similar to U.S. markets, these sales levels were not repeated in fiscal 2011, as evidenced by the approximate 13%12% decline in thisour European Diagnostic operating segment’s upper respiratory product salessegment on an organic basis (excluding effects of currency translation) compared to the first nine months of fiscal 2010.

basis.

Group Purchasing Organizations and Integrated Delivery Networks

In our U.S. Diagnostics operating segment, consolidation of the U.S. healthcare industry over the last several years has led to the creation of group purchasing organizations (GPOs) and integrated delivery networks (IDNs) that aggregate buying power for hospital groups and put pressure on our selling prices. We have multi-year supply agreements with several GPOs. During the third quarterGPOs and first nine months of fiscal 2011, we have experienced approximately $200 and $1,000, respectively,IDNs. These agreements, which resulted in an approximate $115 unfavorable price variance as a resultduring the first quarter of these agreements. However, these agreementsfiscal 2012, help secure our products with these customers and have ledlead to new business. While in the near term this has negatively impacted gross profit, further increases in volumes are expected from these contracts.

Foreign Currency
Sales for our European Diagnostics operating segment included the effect of more favorable currency rates, which led to currency translation gains in the amount of approximately $650 for the third quarter of fiscal 2011, compared to $350 of currency translation losses in the fiscal 2010 third quarter. During the first nine months of fiscal 2011, translation gains of approximately $165 were experienced, compared to $550 of currency translation gains during the comparable prior year period.

12


Life Science Operating Segment

Sales for our Life Science operating segment increased 47%10% for the thirdfirst quarter of fiscal 20112012, reflecting increases in both our viral antigen and 50%molecular reagent businesses of 8% and 13%, respectively. The increase in the viral antigen business largely results from increased orders for Rubella and Hepatitis A proteins, while the nine month fiscal year-to-date period, due primarily to the revenue contribution of themolecular reagent business, operated through our Bioline Group, acquired in July 2010. Excludinghas benefitted from its new product launches and advancements during recent months – most notably its new SensiFAST™ and MyTaq™ PCR components.

Foreign Currency

During the first quarter of fiscal 2012, currency exchange rates had an approximate $50 unfavorable impact ofon revenue; $35 within the Bioline Group, sales for theEuropean Diagnostic operating segment declined 12% and 10% during$15 in the three and nine month periods, respectively, as this business continues to experience both pricing pressure and reduced order volumes in several key product lines. For fiscal 2011, we expect revenues for our core Life Science businessoperating segment. This compares to decline 6%-8%, whilecurrency exchange having an approximate $435 unfavorable impact on revenue in the Bioline Group is expected to contribute approximately $15,000.

first quarter of fiscal 2011.

Page 16


Significant Customers

Two national distributors in our U.S. Diagnostics operating segment accounted for 47%50% and 52% of total sales for this operating segment for the thirdfirst quarters of fiscal 2012 and 2011, and 2010, respectively, and 50% and 58% during the nine months ended June 30, 2011 and 2010, respectively. The lower percentage of sales reflects the fact that the majority of ourillumigene® product sales are direct, as well as the comparative decline in these distributors’ inventory stocking of influenza and other products.

Three

Two diagnostic manufacturing customers in our Life Science operating segment accounted for 17%27% and 29%16% of total sales for this operating segment for the thirdfirst quarters of fiscal 20112012 and 2010, respectively, and 18% and 33% during the nine months ended June 30, 2011, and 2010, respectively. The lowerhigher percentage of sales during both periods results primarily from the additionbuying pattern of one of the Bioline Group.

customers.

Operating Segment Revenues

Our reportable operating segments are U.S. Diagnostics, European Diagnostics and Life Science. Initial segmentation between Diagnostics and Life Science has been determined based upon products and customers, with further segmentation of Diagnostics between U.S. and European being based upon geographic regions served and management responsibility. The U.S. Diagnostics operating segment consists of manufacturing operations in Cincinnati, Ohio, and the sale and distribution of diagnostic test kits in the U.S. and countries outside of Australia, Europe, Africa and the Middle East. The European Diagnostics operating segment consists of the sale and distribution of diagnostic test kits in Australia, Europe, Africa and the Middle East. The Life Science operating segment consists of manufacturing operations in Memphis, Tennessee; Saco, Maine; Boca Raton, Florida; London, England; Luckenwalde, Germany; and Sydney, Australia, and the sale and distribution of bulk antigens, antibodies, PCR/qPCR reagents, nucleotides, competent cells and bioresearch reagents domestically and abroad. During the fourth quarter of fiscal 2011, plans were announced to consolidate the Saco, Maine operations into the Memphis, Tennessee facility, with such consolidation commencing early in the fiscal 2012 first quarter and expected to be completed in the third quarter of fiscal 2012. The Life Science operating segment also includes the contract development and manufacture of cGMP clinical grade proteins and other biologicals for use by biopharmaceutical and biotechnology companies engaged in research for new drugs and vaccines.

Revenues for the Diagnostics operating segments, in the normal course of business, may be affected from quarter to quarter by buying patterns of major distributors, seasonality and strength of certain diseases, and foreign currency exchange rates. Revenues for the Life Science operating segment, in the normal course of business, may be affected from quarter to quarter by the timing and nature of arrangements for contract services work, which may have longer production cycles than bioresearch reagents and bulk antigens and antibodies, as well as buying patterns of major customers.customers, and foreign currency exchange rates. We believe that the overall breadth of our product lines serves to reduce the variability in consolidated revenues.

The Company has experienced no material adverse impact on revenue as a result of the disaster in Japan earlier this year, nor is any material adverse impact anticipated at this time, although no assurances can be given with regard to material adverse impacts that may arise in the future despite being unanticipated as of the date of this report. In addition, the Company’s supply of product and product components has not been and is not expected to be adversely impacted by the disaster.

13


Revenues for each of our operating segments are shown below.

                         
  Three Months Ended June 30,  Nine Months Ended June 30, 
  2011  2010  Inc (Dec)  2011  2010  Inc (Dec) 
U.S. Diagnostics $23,829  $21,121   13% $72,007  $70,018   3%
European Diagnostics  6,612   6,218   6%  18,926   19,103   (1)%
Life Science  9,611   6,518   47%  27,441   18,340   50%
                   
Consolidated $40,052  $33,857   18% $118,374  $107,461   10%
                   
                         
International -                        
U.S. Diagnostics $1,845  $1,401   32% $5,058  $4,378   16%
European Diagnostics  6,612   6,218   6%  18,926   19,103   (1)%
Life Science  5,365   3,085   74%  15,238   8,337   83%
                   
Total $13,822  $10,704   29% $39,222  $31,818   23%
                   
% of total sales  35%  32%      33%  30%    
                   

 

September 30,September 30,September 30,
     Three Months Ended December 31, 
     2011  2010  Inc (Dec) 

U.S. Diagnostics

    $25,200  $22,650   11

European Diagnostics

     5,505   5,929   (7)% 

Life Science

     9,561   8,684   10
    

 

 

  

 

 

  

 

 

 

Consolidated

    $40,266  $37,263   8
    

 

 

  

 

 

  

 

 

 

International -

      

U.S. Diagnostics

    $1,485  $1,596   (7)% 

European Diagnostics

     5,505   5,929   (7)% 

Life Science

     5,720   4,589   25
    

 

 

  

 

 

  

 

 

 

Total

    $12,710  $12,114   5
    

 

 

  

 

 

  

 

 

 

% of total sales

     32  33 
    

 

 

  

 

 

  

Page 17


Gross Profit
                         
  Three Months Ended June 30,  Nine Months Ended June 30, 
  2011  2010  Change  2011  2010  Change 
Gross Profit $25,426  $21,736   17% $75,328  $67,388   12%
                         
Gross Profit Margin  63%  64% -1 point  64%  63% +1 point
                   
Gross

September 30,September 30,September 30,
     Three Months Ended December 31, 
     2011  2010  Change 

Gross Profit

    $24,733  $23,502   5

Gross Profit Margin

     61  63  -2 points  
    

 

 

  

 

 

  

 

 

 

The overall gross profit margin improvementdecline for the first ninethree months of fiscal 20112012 results primarily from the combined effects of 1) the margin contributionmix of Bioline Group products in fiscal 2011; 2) continued operating efficiencies in our Cincinnati, Ohio diagnostic test manufacturing facility; and 3)sold, as well as the year-over-year decline in upper respiratory product sales. Our upper respiratory product family generally has a lower gross profit margin than our other focus product families (C. difficile,H. pyloriand foodborne). Salesmix of upper respiratory products during the first nine months of fiscal 2011 were approximately 11% of our consolidated sales compared to 18% of consolidated sales for the comparable fiscal 2010 period. Specifically, sales offrom the Company’s influenza products represented approximately 2% of consolidated sales during the nine months ended June 30, 2011, compared to approximately 8% in the first nine months of fiscal 2010.

operating segments.

Our overall operations consist of the sale of diagnostic test kits for various disease states and in alternative test formats, as well as bioresearch reagents, bulk antigens, antibodies, PCR/qPCR reagents, nucleotides, competent cells, proficiency panels, contract research and development, and contract manufacturing services. Product sales mix shifts, in the normal course of business, can cause the consolidated gross profit margin to fluctuate by several points.

Operating Expenses

                     
  Three Months Ended June 30, 2011 
  Research &  Selling &  General &      Total Operating 
  Development  Marketing  Administrative  Other (1)  Expenses 
2010 Expenses
 $2,128  $4,287  $4,872  $673  $11,960 
                
% of Sales  6%  13%  14%  2%  35%
                     
Fiscal 2011 Increases (Decreases):                    
U.S. Diagnostics  521   754   (15)     1,260 
European Diagnostics     87   (27)     60 
Life Science                    
- Bioline Group  173   1,037   1,817      3,027 
- Core  (112)  (22)  (205)     (339)
- Transaction Costs           (673)  (673)
                
                     
2011 Expenses
 $2,710  $6,143  $6,442  $  $15,295 
                
% of Sales  7%  15%  16%  %  38%
% Increase (Decrease)  27%  43%  32%  (100)%  28%
                

September 30,September 30,September 30,September 30,September 30,
     Research &
Development
  Selling &
Marketing
  General &
Administrative
  Plant
Consolidation
  Total Operating
Expenses
 

Q1 2011 Expenses

    $2,309  $5,475  $6,628  $—     $14,412 
    

 

 

  

 

 

  

 

 

  

 

 

  

 

 

 

% of Sales

     6  15  18  —    39

Fiscal 2012 Increases (Decreases):

        

U.S. Diagnostics

     109   (144  119   —      84 

European Diagnostics

     —      (31  204   —      173 

Life Science

     (145  268   (308  444   259 
    

 

 

  

 

 

  

 

 

  

 

 

  

 

 

 

Q1 2012 Expenses

    $2,273  $5,568  $6,643  $444  $14,928 
    

 

 

  

 

 

  

 

 

  

 

 

  

 

 

 

% of Sales

     6  14  16  1  37

% Increase (Decrease)

     (2)%   2  —    NMF    4

 

Page 18

14


Operating Expenses
                     
  Nine Months Ended June 30, 2011 
  Research &  Selling &  General &      Total Operating 
  Development  Marketing  Administrative  Other (1)  Expenses 
2010 Expenses
 $6,521  $13,495  $14,042  $673  $34,731 
                
% of Sales  6%  13%  13%  1%  32%
                     
Fiscal 2011 Increases (Decreases):                    
U.S. Diagnostics  343   1,612   326   365   2,646 
European Diagnostics     20   (115)  875   780 
Life Science                    
- Bioline Group  527   2,772   4,484      7,783 
- Core  (8)  (52)  (62)     (122)
- Transaction Costs           (673)  (673)
                
                     
2011 Expenses
 $7,383  $17,847  $18,675  $1,240  $45,145 
                
% of Sales  6%  15%  16%  1%  38%
% Increase  13%  32%  33%  84%  30%
                
(1)Comprised of transaction costs for our acquisition of the Bioline Group (2010) and costs related to reorganizing our European and Global Sales & Marketing Leadership (2011).
We continue to closely control spending for each of our operating segments.
The quarterly and year-to-date increasesOverall, the relatively modest increase in all three ongoingtotal operating expense categories (i.e., Research & Development, Selling & Marketing, and General & Administrative)during the first quarter of approximately $4,000 and $9,800, respectively, resultfiscal 2012 results in large part from the addition of the Bioline Group’s operating expenses. Additionally, operating expenses for the U.S. Diagnostics operating segment reflect thecombined effects of our (i) ongoing efforts to control spending in each of our operating segments while investing the following:
Research & Development
Increased personnel-related costs of approximately $200 and $300 for the quarterly and nine month year-to-date periods, respectively, in line with the overall increase in spending on new product development.
Selling & Marketing
1)
Increased sales bonus and commissions expense of approximately $300 and $600 for the quarterly and nine month year-to-date periods, respectively, due to theillumigene® launch and sales growth;
2)Increased samples and promotional expense of approximately $300 for the nine month year-to-date period, resulting in large partnecessary resources in our strategic areas of growth; (ii) beginning to realize cost savings from efforts during the second quarter to move flu inventory manufactured by third parties prior to its expiration; and
3)
Increased travel and trade show expenses during the quarterly and nine month year-to-date periods of approximately $345 and $640, respectively, due in large part to theillumigene® launch costs.
General & Administrative
The positive effects of overall cost containment and reduction efforts being dramatically impacted by approximately $850 of stock-based compensation expense during the nine month year-to-date period — approximately $400 of which related to restricted stock grants during the fiscal 2011 first quarter, and an approximate $450 impact on the fiscal 2011 third quarter related to retirement eligible employees.

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During the second quarterconsolidation of fiscal 2011, the Company incurredour Core Life Science operations into one facility; and (iii) incurring approximately $1,240$444 of costs in connection with the reorganizationconsolidation of our European and Global Sales and Marketing Leadership. Approximately 75% of theseSaco, Maine operations into our Memphis, Tennessee location. The facility consolidation costs relatedincurred during the quarter relate primarily to severance benefitsretention bonus costs for the former President and Managing Director of our European diagnostics business, with no further such costs anticipatedpersonnel scheduled to terminate at this time.
varying times during fiscal 2012.

Operating Income

Operating income increased 4%8% to $10,131$9,805 for the thirdfirst quarter of fiscal 2011, and decreased 8% to $30,183 for the first nine months of fiscal 2011,2012, as a result of the factors discussed above.

Other Income and Expense

The increase in other income, net, during the nine month year-to-date periodfirst three months of fiscal 2012 can primarily be attributed to the additionnet effects of the Bioline Group, as it contributed to an improvement in net currency exchange gains/losses of approximately $100$250 and a decrease in grant income from a foreign governmental agency of approximately $200.

$80.

Income Taxes

The effective rate for income taxes was 33% for the third quarter and 34%35% for the first nine monthsquarters of both fiscal 2011, each of which is one percentage point lower than the corresponding periods of fiscal 2010. This decrease in rates primarily results from the fiscal 2011 third quarter release of reserves for certain uncertain tax positions due to the passage of the relevant statute of limitations.2012 and 2011. For the fiscal year ending September 30, 2011,2012, we expect the effective tax rate to also approximate 35%.

Liquidity and Capital Resources

Comparative Cash Flow Analysis

Our cash flow and financing requirements are determined by analyses of operating and capital spending budgets, consideration of acquisition plans, and consideration of common share dividends. We have historically maintained a credit facility to augment working capital requirements and to respond quickly to acquisition opportunities. Our investment portfolio presently contains overnight repurchase agreements. We used $23,849 from our investment portfolio to complete the acquisition of the Bioline Group during July 2010.

We have an investment policy that guides the holdings of our investment portfolio. Our objectives in managing the investment portfolio are to (i) preserve capital; (ii) provide sufficient liquidity to meet working capital requirements and fund strategic objectives such as acquisitions; and (iii) capture a market rate of return commensurate with market conditions and our policy’s investment eligibility criteria. As we look forward, we will continue to manage the holdings of our investment portfolio with preservation of capital being the primary objective.

Except as otherwise described herein,

At the present time, we do not expect current conditions in the financial markets, or overall economic conditions to have a significant impact on our liquidity needs, financial condition, or results of operations.operations, although no assurances can be made in this regard. We intend to continue to fund our working capital requirements and dividends from current cash flows from operating activities and cash on hand. We also have an additional source of liquidity through our $30,000 bank credit facility, if needed.

To date, except for the Italian matter discussed below, we have not experienced any significant deterioration in the aging of our customer accounts receivable nor in our vendors’ ability to supply raw materials and services and extend normal credit terms. Approximately $4,900 of our accounts receivable at December 31, 2011 is due from Italian hospital customers whose funding ultimately comes from the Italian government. The magnitude of the sovereign debt crisis in Europe, and Italy in particular, is significant. We have experienced a deterioration in the aging of our Italian accounts receivable and continue to monitor the situation closely. Our liquidity needs may change if overall economic conditions worsen and/or liquidity and credit within the financial markets remains tight for an extended period of time, and such conditions impact the collectibility of our customer accounts receivable or credit terms with our vendors, or disrupt the supply of raw materials and services.

Net cash provided by operating activities decreased 30%8% for the first nine monthsquarter of fiscal 20112012 to $16,618,$12,497, reflecting the 6% decrease9% increase in net earnings and the effects of net working capital changes related to our investments inillumigene® inventory including readers, fluctuations in sales levels, and the timing of payments with suppliers. Net cash flows from operating activities and cash on hand are anticipated to be adequate to fund working capital requirements and dividends during the next 12 months. During the last sixeight fiscal quarters, the per share amount of our cash dividend has exceeded the per share amount of our diluted earnings. As we enterDuring the second half of fiscal 2012, management expects that this relationship will change; meaning

15


we believe that the per share amount of our diluted earnings will exceed the per share amount of our current cash dividend, although no assurances can be made in this regard.

During the first quarter of fiscal 2012, cash generated from the Company’s operating activities exceeded the quarterly dividend.

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Capital Resources

We have a $30,000 credit facility with a commercial bank which expires on September 15, 2012. As of JulyJanuary 31, 2011,2012, there were no borrowings outstanding on this facility and we had 100% borrowing capacity available to us. We have had no borrowings outstanding under this facility during the first ninethree months of fiscal 2011,2012, or during the full year of fiscal 2010.

2011.

Our capital expenditures for the balance of fiscal 2011 are estimated to berange between approximately $1,700.$3,000 to $5,000 for fiscal 2012, with the actual amount depending upon actual operating results and the phasing of certain projects. Such expenditures may be funded with cash and cash equivalents on hand, operating cash flows, and/or availability under the $30,000 credit facility discussed above. Capital expenditures relate to manufacturing and other equipment of a normal and recurring nature, as well as costs associated with production line automation in Cincinnati, facilities expansions in Cincinnati and Memphis, and computer system and software purchases for the Bioline Group. We also expect to have approximately $1,700 in expenditures for readers to support the ongoingillumigene® product launch.

We do not utilize any special-purpose financing vehicles or have any undisclosed off-balance sheet arrangements.

ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

There have been no material changes in the Company’s exposure to market risk since September 30, 2010.

2011.

ITEM 4. CONTROLS AND PROCEDURES

As of June 30,December 31, 2011, an evaluation was completed under the supervision and with the participation of our management, including our Chief Executive Officer and Chief Financial Officer, of the effectiveness of the design and operation of our disclosure controls and procedures pursuant to Rule 13a-15(b) and 15d-15(b) promulgated under the Securities Exchange Act of 1934, as amended. Based on that evaluation, our management, including the CEO and CFO, concluded that our disclosure controls and procedures were effective as of June 30,December 31, 2011. There have been no changes in our internal control over financial reporting identified in connection with the evaluation of internal control that occurred during the thirdfirst fiscal quarter that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting, or in other factors that could materially affect internal control subsequent to June 30,December 31, 2011.

 

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PART II. OTHER INFORMATION

ITEM 1A. RISK FACTORS

There have been no material changes from risk factors as previously disclosed in the Registrant’s Form 10-K in response to Item 1A to Part I of Form 10-K.

ITEM 6. EXHIBITS

The following exhibits are being filed or furnished as a part of this Quarterly Report on Form 10-Q.

10.6*  2004 Equity Compensation Plan, Amended and Restated through January 25, 2012
10.4*10.16*  Salary Continuation Agreement between Meridian Bioscience, Inc. and John A. Kraeutler, as amended April 24, 2001, December 29, 2008 and August 3, 2011 (Filed herewith)2012 Stock Incentive Plan
31.1  Certification of Principal Executive Officer Pursuant to Securities Exchange Act Rule 13a-14(a)/15d-14(a) (Filed herewith)
31.2  Certification of Principal Financial Officer Pursuant to Securities Exchange Act Rule 13a-14(a)/15d-14(a) (Filed herewith)
32  Certification of Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (Filed herewith)
*101  The following financial information from Meridian Bioscience, Inc.’s Quarterly Report on Form 10-Q for the quarter ended December 31, 2011 filed with the SEC on February 9, 2012, formatted in XBRL includes: (i) Condensed Consolidated Statements of Operations for the three months ended December 31, 2011 and 2010, (ii) Condensed Consolidated Statements of Cash Flows for the three months ended December 31, 2011 and 2010, (iii) Condensed Consolidated Balance Sheets as of December 31, 2011 and September 30, 2011, (iv) Condensed Consolidated Statement of Changes in Shareholders’ Equity for the three months ended December 31, 2011, and (v) the Notes to Condensed Consolidated Financial Statements

*

Management Compensatory Arrangement

 

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17


SIGNATURE

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.

  
 

MERIDIAN BIOSCIENCE, INC.

Date:February 9, 2012

 
Date: August 9, 2011 /s/ Melissa A. Lueke
 
 

Melissa A. Lueke

Executive Vice President and
Chief Financial Officer

 

 

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