Annual Statements Open main menu

MERIDIAN BIOSCIENCE INC - Quarter Report: 2010 March (Form 10-Q)

10-Q
Table of Contents

 
 
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 10-Q
     
þ   QUARTERLY REPORT PURSUANT TO SECTION 13 or 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the Quarterly Period Ended March 31, 2010
OR
     
o   TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from                      to                     
Commission file number 0-14902
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.
Yes þ No o
Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).
Yes o No o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See definitions of “large accelerated filer,” ”accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act.
             
Large accelerated filer þ   Accelerated filer o   Non-accelerated filer o   Smaller reporting company o
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).
Yes o No þ
Indicate the number of shares outstanding of each of the issuer’s classes of common stock, as of the latest practicable date.
     
Class   Outstanding April 30, 2010
     
Common Stock, no par value   40,630,495
 
 

 

 


 

MERIDIAN BIOSCIENCE, INC. AND SUBSIDIARIES
INDEX TO QUARTERLY REPORT ON FORM 10-Q
         
    Page(s)  
 
       
       
 
       
       
 
    1  
 
       
    2  
 
       
    3-4  
 
       
    5  
 
       
    6-13  
 
       
    13-19  
 
       
    19  
 
       
    19  
 
       
       
 
       
    19  
 
    19  
 
    20  
 
       
    21  
 
       
 Exhibit 31.1
 Exhibit 31.2
 Exhibit 32
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. 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 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. Changes in the relative strength or weakness of the U.S. dollar can also change expected results. 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 successfully integrated into Meridian’s operations. The Company cannot predict the possible effects of potential healthcare reform in the United States and 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.

 

 


Table of Contents

PART I. FINANCIAL INFORMATION
Item 1.    Financial Statements
MERIDIAN BIOSCIENCE, INC. AND SUBSIDIARIES
Consolidated Statements of Operations (Unaudited)
(in thousands, except per share data)
                                 
    Three-months Ended     Six-months Ended  
    March 31,     March 31,  
    2010     2009     2010     2009  
NET SALES
  $ 31,147     $ 33,280     $ 73,604     $ 67,573  
 
                               
COST OF SALES
    10,980       12,306       27,952       23,255  
 
                       
 
                               
GROSS PROFIT
    20,167       20,974       45,652       44,318  
 
                       
 
                               
OPERATING EXPENSES
                               
Research and development
    2,315       2,339       4,393       4,403  
Selling and marketing
    4,321       3,975       9,208       8,942  
General and administrative
    4,406       3,655       9,170       7,810  
 
                       
Total operating expenses
    11,042       9,969       22,771       21,155  
 
                       
 
                               
OPERATING INCOME
    9,125       11,005       22,881       23,163  
 
                               
OTHER INCOME (EXPENSE)
                               
Interest income
    30       84       61       346  
Other, net
    110       76       (8 )     (72 )
 
                       
Total other income (expense)
    140       160       53       274  
 
                       
 
                               
EARNINGS BEFORE INCOME TAXES
    9,265       11,165       22,934       23,437  
 
                               
INCOME TAX PROVISION
    3,285       3,914       8,033       8,110  
 
                       
 
                               
NET EARNINGS
  $ 5,980     $ 7,251     $ 14,901     $ 15,327  
 
                       
 
                               
BASIC EARNINGS PER COMMON SHARE
  $ 0.15     $ 0.18     $ 0.37     $ 0.38  
 
                               
DILUTED EARNINGS PER COMMON SHARE
  $ 0.15     $ 0.18     $ 0.36     $ 0.37  
 
                               
AVERAGE NUMBER OF COMMON SHARES OUTSTANDING — BASIC
    40,514       40,385       40,504       40,349  
 
                               
EFFECT OF DILUTIVE STOCK OPTIONS
    663       748       674       779  
 
                               
AVERAGE NUMBER OF COMMON SHARES OUTSTANDING — DILUTED
    41,177       41,133       41,178       41,128  
 
                       
 
                               
ANTI-DILUTIVE SECURITIES:
                               
Common share options
    215       141       193       125  
 
                       
 
                               
DIVIDENDS DECLARED PER COMMON SHARE
  $ 0.19     $ 0.17     $ 0.36     $ 0.31  
 
                       
The accompanying notes are an integral part of these consolidated financial statements.

 

Page 1


Table of Contents

MERIDIAN BIOSCIENCE, INC. AND SUBSIDIARIES
Consolidated Statements of Cash Flows (Unaudited)
(dollars in thousands)
                 
Six Months Ended March 31   2010     2009  
CASH FLOWS FROM OPERATING ACTIVITIES:
               
Net earnings
  $ 14,901     $ 15,327  
Non-cash items:
               
Depreciation of property, plant and equipment
    1,530       1,468  
Amortization of intangible assets
    734       799  
Stock based compensation
    921       544  
Deferred income taxes
    (1,135 )     (579 )
Loss on disposition of fixed assets
    13       39  
Unrealized loss on auction-rate securities and rights, net
    12       220  
Change in accounts receivable, inventory, and prepaid expenses
    2,944       (2,073 )
Change in accounts payable, accrued expenses, and income taxes payable
    (3,853 )     (3,382 )
Other
    560       300  
 
           
Net cash provided by operating activities
    16,627       12,663  
 
           
 
               
CASH FLOWS FROM INVESTING ACTIVITIES:
               
Acquisitions of property, plant and equipment
    (2,124 )     (1,734 )
Proceeds from sales of property, plant and equipment
          5  
Acquisition earnout payments
          (7 )
Purchases of short-term investments
    (1,000 )      
Proceeds from calls of auction-rate securities
          425  
 
           
Net cash used for investing activities
    (3,124 )     (1,311 )
 
           
 
               
CASH FLOWS FROM FINANCING ACTIVITIES:
               
Dividends paid
    (14,580 )     (12,510 )
Proceeds and tax benefits from exercises of stock options
    522       516  
Other
          (7 )
 
           
Net cash used for financing activities
    (14,058 )     (12,001 )
 
           
 
               
Effect of Exchange Rate Changes on Cash and Equivalents
    (681 )     (342 )
 
               
Net Decrease in Cash and Equivalents
    (1,236 )     (991 )
 
               
Cash and Equivalents at Beginning of Period
    54,030       49,297  
 
           
 
               
Cash and Equivalents at End of Period
  $ 52,794     $ 48,306  
 
           
The accompanying notes are an integral part of these consolidated financial statements.

 

Page 2


Table of Contents

MERIDIAN BIOSCIENCE, INC. AND SUBSIDIARIES
Consolidated Balance Sheets (Unaudited)
(dollars in thousands)
ASSETS
                 
    March 31,     September 30,  
    2010     2009  
CURRENT ASSETS:
               
Cash and equivalents
  $ 52,794     $ 54,030  
Short-term investments
    8,273       7,285  
Accounts receivable, less allowances of $289 and $247
    17,897       26,981  
Inventories
    28,488       23,284  
Prepaid expenses and other current assets
    3,682       3,632  
Deferred income taxes
    2,208       1,935  
 
           
 
               
Total current assets
    113,342       117,147  
 
           
 
               
PROPERTY, PLANT AND EQUIPMENT:
               
Land
    880       894  
Buildings and improvements
    19,651       19,718  
Machinery, equipment and furniture
    30,952       30,997  
Construction in progress
    2,384       1,586  
 
           
Subtotal
    53,867       53,195  
Less: accumulated depreciation and amortization
    32,851       32,721  
 
           
 
               
Net property, plant and equipment
    21,016       20,474  
 
           
 
               
OTHER ASSETS:
               
Goodwill
    9,866       9,866  
Other intangible assets, net
    6,611       7,317  
Restricted cash
    1,000       1,000  
Other assets
    206       193  
 
           
 
               
Total other assets
    17,683       18,376  
 
           
 
               
TOTAL ASSETS
  $ 152,041     $ 155,997  
 
           
The accompanying notes are an integral part of these consolidated financial statements.

 

Page 3


Table of Contents

MERIDIAN BIOSCIENCE, INC. AND SUBSIDIARIES
Consolidated Balance Sheets (Unaudited)
(dollars in thousands)
LIABILITIES AND SHAREHOLDERS’ EQUITY
                 
    March 31,     September 30,  
    2010     2009  
CURRENT LIABILITIES:
               
Accounts payable
  $ 4,193     $ 6,901  
Accrued employee compensation costs
    3,604       5,338  
Other accrued expenses
    4,077       3,803  
Income taxes payable
    850       710  
 
           
 
               
Total current liabilities
    12,724       16,752  
 
           
 
               
DEFERRED INCOME TAXES
    435       1,340  
 
               
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, 40,630,383 and 40,493,313 shares issued, respectively
           
Additional paid-in capital
    93,067       91,668  
Retained earnings
    45,836       45,515  
Accumulated other comprehensive income (loss)
    (21 )     722  
 
           
 
               
Total shareholders’ equity
    138,882       137,905  
 
           
 
               
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY
  $ 152,041     $ 155,997  
 
           
The accompanying notes are an integral part of these consolidated financial statements.

 

Page 4


Table of Contents

MERIDIAN BIOSCIENCE, INC. AND SUBSIDIARIES
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, 2009
    40,493     $ 91,668     $ 45,515     $ 722           $ 137,905  
Cash dividends paid
                (14,580 )                   (14,580 )
Exercise of stock options
    41       478                           478  
Issuance of restricted shares
    96                                  
Stock based compensation
          921                           921  
Comprehensive income:
                                               
Net earnings
                14,901           $ 14,901       14,901  
Other comprehensive income taxes
                      399       399       399  
Foreign currency translation adjustment
                      (1,142 )     (1,142 )     (1,142 )
 
                                             
Comprehensive income
                                  $ 14,158          
 
                                   
 
                                               
Balance at March 31, 2010
    40,630     $ 93,067     $ 45,836     $ (21 )         $ 138,882  
 
                                   
The accompanying notes are an integral part of these consolidated financial statements.

 

Page 5


Table of Contents

MERIDIAN BIOSCIENCE, INC. AND SUBSIDIARIES
Notes to Consolidated Financial Statements
Dollars in Thousands, Except Per Share Amounts
(Unaudited)
1.  
Basis of Presentation:
The consolidated financial statements included herein have not been audited by an independent registered public accounting firm, but include all adjustments (consisting of normal recurring entries), which are, in the opinion of management, necessary for a fair presentation of the results for such periods.
Certain information and footnote disclosures normally included in financial statements prepared in accordance with generally accepted accounting principles have been omitted pursuant to the requirements of the Securities and Exchange Commission. We believe that the disclosures included in these financial statements are adequate to make the information not misleading.
It is suggested that these consolidated interim financial statements be read in conjunction with the consolidated annual financial statements and notes thereto, included in Meridian’s Annual Report on Form 10-K for the Year Ended September 30, 2009.
The results of operations for interim periods are not necessarily indicative of the results to be expected for the year.
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 US 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 historical statistics, current trends, and other factors. Changes to the accruals are recorded in the period that they become known. Our rebate accruals were $5,318 at March 31, 2010 and $4,750 at September 30, 2009.
   
Life Science revenue for contract services may come from standalone arrangements for process development and/or optimization work (contract research and development services) or custom manufacturing, or multiple-deliverable arrangements that include process development work followed by larger-scale manufacturing (both contract research and development services and contract manufacturing services). Revenue is recognized based on each of the multiple deliverables in a given arrangement having distinct and separate fair values. Fair values are determined via consistent pricing between standalone arrangements and multiple deliverable arrangements, as well as 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.
   
Trade accounts receivable are recorded in the accompanying consolidated balance sheet 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.

 

Page 6


Table of Contents

  (b)  
Comprehensive Income (Loss) —
   
Our comprehensive income or loss is comprised of net earnings, foreign currency translation, changes in the fair value of forward exchange contracts accounted for as cash flow hedges (fiscal 2009 only), and changes in the fair value of available-for-sale (AFS) fixed income securities (fiscal 2009 only).
   
Assets and liabilities of foreign operations are translated using period-end exchange rates with gains or losses resulting from translation included in a separate component of accumulated other 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 Euro currency. These gains and losses are included in other income and expense in the accompanying consolidated statements of operations.
   
Comprehensive income for the interim periods was as follows:
                                 
    Three Months     Six Months  
    Ended March 31,     Ended March 31,  
    2010     2009     2010     2009  
 
                               
Net earnings
  $ 5,980     $ 7,251     $ 14,901     $ 15,327  
Hedging activity
          19             (3 )
Transfer of AFS securities to trading classification
                      270  
Income taxes
    310       254       399       249  
Foreign currency translation adjustment
    (885 )     (744 )     (1,142 )     (978 )
 
                       
Comprehensive income
  $ 5,405     $ 6,780     $ 14,158     $ 14,865  
 
                       
  (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 consolidated statements of operations.
  (d)  
Share-based Compensation —
   
We recognize compensation expense for all share-based awards made to employees based upon the fair value of the share-based award on the date of the grant. Shares are expensed over their requisite service period.

 

Page 7


Table of Contents

  (e)  
Cash, Cash Equivalents, and Investments —
   
Our investment portfolio includes the following components:
                                 
    March 31, 2010     September 30, 2009  
    Cash and             Cash and        
    Equivalents     Other     Equivalents     Other  
Taxable investments -
                               
Overnight repurchase agreements
  $ 14,095     $     $     $  
Money market funds
    28,275             29,032        
Fixed-rate municipal note
          1,000              
 
                               
Tax-exempt investments -
                               
Money market funds
    143             10,383        
Student loan auction-rate securities and rights
          7,273             7,285  
 
                               
Cash on hand -
                               
Restricted
          1,000             1,000  
Unrestricted
    10,281             14,615        
 
                       
Total
  $ 52,794     $ 9,273     $ 54,030     $ 8,285  
 
                       
   
Our investment portfolio includes student loan auction-rate securities, which are long-term student loan revenue bonds whose interest rates are reset every 35 days via a Dutch auction process. All of our auction-rate securities are backed by pools of student loans originated under the Federal Family Education Loan Program (FFELP). FFELP student loans are guaranteed by State guarantors who have reinsurance agreements with the US Department of Education. All of our student loan auction-rate securities were rated Aaa and AAA by Moody’s and Standard & Poor’s, respectively, at the time of purchase, and have continued to maintain these credit ratings through the present time.
   
The Dutch auction process historically provided the necessary liquidity mechanism to either purchase or sell these securities. Beginning in mid-February 2008, liquidity issues in the US credit markets resulted in the failure of auctions across a broad spectrum of tax-exempt securities, including student loan revenue bonds. Auctions for the student loan revenue bonds that we hold have continued to fail through the present time. The consequence of a failed auction is that we do not have access to the principal amount of our investments, other than through secondary markets. Issuers are still required to make interest payments when due in the event of failed auctions. We have not experienced any missed interest payments to date.
   
Our auction-rate securities were purchased through UBS Financial Services, Inc. During November 2008, we accepted an offer from UBS, AG (UBS) of Auction Rate Security Rights. These rights permit us to require UBS between June 30, 2010 and July 2, 2012 (the exercise period) to purchase our auction-rate securities at par value. In exchange, UBS is granted the right, at their sole discretion, to sell or otherwise dispose of our auction-rate security investments until July 2, 2012 as long as we receive a payment of par value upon the sale or disposition. In addition, the rights permit us to establish a demand revolving credit line in an amount equal to the par value of the securities at a net no cost. We are still able to sell the auction-rate securities on our own, but in such a circumstance, we would lose the par value support from UBS. In February 2010, we notified UBS that we would be exercising our Auction Rate Security Rights effective June 30, 2010. Pursuant to the terms of the Auction Rate Security Rights, we expect to receive the par value of our auction-rate securities within one business day of settlement, on or about July 2, 2010. On May 5, 2010, UBS sold $3,750 of our auction-rate securities at par value. We received the proceeds from this sale on May 6, 2010.
   
Upon executing the settlement agreement with UBS, we recognized the Auction Rate Security Rights as a stand-alone financial instrument and elected the fair value option. We also transferred the student loan auction-rate securities from the available-for-sale classification, to the trading classification. Adjustments to the fair value of student loan auction-rate securities and Auction Rate Security Rights are recorded to other income and expense in each accounting period. As of March 31, 2010, the fair value of the student-loan auction rate securities was $6,711 compared to a par value of $7,275. As of March 31, 2010, the fair value of the Auction Rate Security Rights was $562. The student loan auction-rate securities and Auction Rate Security Rights are included in current assets in the accompanying consolidated balance sheet based on the earliest exercise date of June 30, 2010. As of May 6, 2010, the par value of our auction-rate securities was $3,525, reflecting the sale by UBS discussed above.

 

Page 8


Table of Contents

  (f)  
Recent Accounting Pronouncements —
   
During February 2010, the FASB amended its previously released guidance regarding fair value measurements and disclosures. This amendment requires separate disclosure of the amounts of significant transfers in and out of Level 1 and Level 2 fair value measurements and description of the reasons for such transfers. The guidance also requires disclosure of activity in Level 3 fair value measurements, including separate presentation of purchases, sales, issuances, and settlements. This amended guidance is effective for interim and annual periods beginning after December 15, 2009, except for the disaggregation requirement for the reconciliation disclosure of Level 3 measurements, which is effective for fiscal years beginning after December 15, 2010 and for interim periods within those years. The Company adopted the new guidance during the three months ended March 31, 2010 which did not impact the Company’s consolidated results of operations, cash flows or financial position.
  (g)  
Reclassifications —
   
Certain reclassifications have been made to the prior period financial statements to conform to the current fiscal period presentation.
3.  
Inventories:
Inventories are comprised of the following:
                 
    March 31,     September 30,  
    2010     2009  
Raw materials
  $ 5,920     $ 6,079  
Work-in-process
    7,458       5,916  
Finished goods
    16,038       12,314  
 
           
Gross inventory
    29,416       24,309  
Less: Reserves
    (928 )     (1,025 )
 
           
Net inventory
  $ 28,488     $ 23,284  
 
           
4.  
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 field of life science. Our principal businesses are (i) the development, manufacture and distribution of diagnostic test kits primarily for certain respiratory, gastrointestinal, viral and parasitic infectious diseases, (ii) the manufacture and distribution of bulk antigens, antibodies, and reagents used by researchers and other diagnostic manufacturers and (iii) the contract manufacture of proteins and other biologicals under clinical cGMP conditions for use by biopharmaceutical and biotechnology companies engaged in research for new drugs and vaccines.
Our reportable operating segments are US Diagnostics, European Diagnostics, and Life Science. The US Diagnostics operating segment consists of manufacturing operations in Cincinnati, Ohio, and the sale and distribution of diagnostic test kits in North America, South America and the Pacific Rim. The European Diagnostics operating segment consists of the sale and distribution of diagnostic test kits in Europe, Scandinavia, Africa, and the Middle East. The Life Science operating segment consists of manufacturing operations in Memphis, Tennessee, Saco, Maine, and Boca Raton, Florida, and the sale and distribution of bulk antigens, antibodies and bioresearch reagents domestically and abroad. 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 9


Table of Contents

Two customers accounted for 48% and 50% of the US Diagnostics operating segment third-party sales during the three months ended March 31, 2010 and 2009, respectively, and 61% and 56% during the six months ended March 31, 2010 and 2009, respectively. Two customers accounted for 31% and 25% of the Life Science operating segment third-party sales during the three months ended March 31, 2010 and 2009, respectively, and 32% and 28% during the six months ended March 31, 2010 and 2009, respectively.
Segment information for the interim periods is as follows:
                                         
            European                    
    US Diagnostics     Diagnostics     Life Science     Eliminations(1)     Total  
Three Months Ended March 31, 2010
                                       
Net sales -
                                       
Third-party
  $ 18,193     $ 6,591     $ 6,363     $     $ 31,147  
Inter-segment
    2,550       3       169       (2,722 )      
Operating income
    6,571       1,093       1,320       141       9,125  
Total assets (March 31, 2010)
    128,579       17,564       58,530       (52,632 )     152,041  
 
                                       
Three Months Ended March 31, 2009
                                       
Net sales -
                                       
Third-party
  $ 21,461     $ 6,599     $ 5,220     $     $ 33,280  
Inter-segment
    2,488       6       92       (2,586 )      
Operating income
    8,288       1,255       1,375       87       11,005  
Total assets (September 30, 2009)
    131,586       18,221       55,592       (49,402 )     155,997  
 
                                       
Six months ended March 31, 2010
                                       
Net sales -
                                       
Third-party
  $ 48,897     $ 12,885     $ 11,822     $     $ 73,604  
Inter-segment
    5,477       4       261       (5,742 )      
Operating income
    18,701       2,063       2,224       (107 )     22,881  
 
                                       
Six months ended March 31, 2009
                                       
Net sales -
                                       
Third-party
  $ 44,946     $ 12,270     $ 10,357     $     $ 67,573  
Inter-segment
    4,976       6       280       (5,262 )      
Operating income
    18,675       2,105       2,222       161       23,163  
     
(1)  
Eliminations consist of inter-segment transactions.
Transactions between operating segments are accounted for at established intercompany prices for internal and management purposes with all intercompany amounts eliminated in consolidation. Total assets for the US Diagnostics and Life Science operating segments include goodwill of $1,381 and $8,485, respectively, at March 31, 2010 and September 30, 2009.

 

Page 10


Table of Contents

5.  
Intangible Assets:
A summary of our acquired intangible assets subject to amortization, as of March 31, 2010 and September 30, 2009 is as follows:
                                         
    Wtd              
    Avg     March 31, 2010     September 30, 2009  
    Amort     Gross             Gross        
    Period     Carrying     Accumulated     Carrying     Accumulated  
    (Yrs)     Value     Amortization     Value     Amortization  
 
                                       
Manufacturing technologies, core products and cell lines
    19     $ 10,124     $ 7,342     $ 10,755     $ 7,672  
Trademarks, licenses and patents
    13       1,658       903       2,772       1,974  
Customer lists and supply agreements
    14       8,505       5,431       11,040       7,604  
 
                             
 
          $ 20,287     $ 13,676     $ 24,567     $ 17,250  
 
                             
The actual aggregate amortization expense for these intangible assets for the three months ended March 31, 2010 and 2009 was $339 and $394, respectively. The actual aggregate amortization expense for these intangible assets for the six months ended March 31, 2010 and 2009 was $734 and $799, respectively.
6.  
Hedging Transactions:
Prior to February 1, 2009, we managed exchange rate risk related to forecasted intercompany sales denominated in the Euro currency through the use of forward exchange contracts and designated such forward contracts as cash flow hedges. As such, the effective portion of the gain or loss on the derivative instrument was reported as a component of other comprehensive income and reclassified into revenues in the Consolidated Statement of Operations in the same period or periods during which the hedged transaction affected earnings. As of March 31, 2010 and September 30, 2009, we had no such contracts outstanding.
During January 2009, €500 notional amount of these contracts were settled in accordance with their original maturities. The realized gain on these contracts was $32. Also during January 2009, we accelerated the settlement of the remaining €2,700 notional amount of forward exchange contracts that were originally scheduled to mature between February 27, 2009 and December 31, 2009. These transactions resulted in a gain of approximately $140 that was recorded in the second quarter of fiscal 2009. We unwound these forward exchange contracts after completing a strategic review of our foreign currency exposures. This strategic review revealed that we have natural currency hedges in place for consolidated gross profit and operating income via certain Meridian-branded diagnostic test kits that we purchase in Euros from suppliers in Spain and Germany.
7.  
Fair Value Measurements:
We value certain financial assets and liabilities at fair value. 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.

 

Page 11


Table of Contents

Level 3: Unobservable inputs, developed using the Company’s 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, the Company utilizes valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible and considers counterparty credit risk in the assessment of fair value.
Financial assets and liabilities carried at fair value at March 31, 2010 and September 30, 2009 and are classified in the tables below into one of the three categories described above:
Balances as of March 31, 2010
                                 
    Level 1     Level 2     Level 3     Total  
Money market funds
  $ 28,418     $     $     $ 28,418  
Student loan auction-rate securities
                6,711       6,711  
UBS Auction-Rate Security Rights
                562       562  
 
                       
Total
  $ 28,418     $     $ 7,273     $ 35,691  
 
                       
Balances as of September 30, 2009
                                 
    Level 1     Level 2     Level 3     Total  
Money market funds
  $ 39,415     $     $     $ 39,415  
Student loan auction-rate securities
                6,708       6,708  
UBS Auction-Rate Security Rights
                577       577  
 
                       
Total
  $ 39,415     $     $ 7,285     $ 46,700  
 
                       

 

Page 12


Table of Contents

The failed auction status and lack of liquidity for our student loan auction-rate securities and the non-transferability of our UBS Auction Rate Security Rights requires the use of a valuation methodology that relies primarily on Level 3 inputs including market, tax status, credit quality, duration, recent market observations and overall capital market liquidity. The valuation of our student loan auction-rate securities and UBS Auction Rate Security Rights is subject to factors that are difficult to predict. Factors that may impact the valuations include changes to credit ratings of the securities as well as to the underlying assets supporting those securities, rates of default of the underlying assets, underlying collateral value, discount rates, counterparty risk and ongoing strength and quality of market credit and liquidity. The following table provides a summary of changes in fair value of Level 3 assets, which include auction-rate securities and UBS Auction Rate Security Rights for the three and six months ended March 31, 2010 and March 31, 2009.
                         
    Student loan     UBS Auction        
    auction-rate     Rate Security        
    securities     Rights     Total Level 3  
Balance at September 30, 2009
  $ 6,708     $ 577     $ 7,285  
Unrealized gains (losses) included in current period earnings
    (26 )     11       (15 )
 
                 
Balance at December 31, 2009
  $ 6,682     $ 588     $ 7,270  
Unrealized gains (losses) included in current period earnings
    29       (26 )     3  
 
                 
Total at March 31, 2010
  $ 6,711     $ 562     $ 7,273  
 
                 
                         
    Student loan     UBS Auction        
    auction-rate     Rate Security        
    securities     Rights     Total Level 3  
Balance at September 30, 2008
  $ 7,480     $     $ 7,480  
Acquire UBS Auction Rate Security Rights
          660       660  
Proceeds from redemptions of auction-rate securities
    (425 )           (425 )
Unrealized gains (losses) included in current period earnings
    (494 )           (494 )
 
                 
Balance at December 31, 2008
  $ 6,561     $ 660     $ 7,221  
Unrealized gains (losses) included in current period earnings
    34       (150 )     (116 )
 
                 
Total at March 31, 2009
  $ 6,595     $ 510     $ 7,105  
 
                 
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.
Overview
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 and results of operations. This discussion should be read in conjunction with the financial statements and notes thereto beginning on page 1.
Our consolidated sales decreased 6% to $31,147 for the second quarter of fiscal 2010 compared to the same period of the prior year, primarily driven by a 51% decrease in sales in Upper Respiratory products for our Diagnostic operating segments. This decrease was partially offset by a 22% increase in sales for our Life Science operating segment, driven by an approximately 50% increase in sales to our two largest customers for this operating segment. Our consolidated operating income and net earnings decreased 17% and 18%, respectively, for the second quarter of fiscal 2010 compared to the same period of the prior year.
Our consolidated sales increased 9% to $73,604 for the first six months of fiscal 2010 compared to the same period of the prior year, primarily driven by volume increases in Upper Respiratory products, H. pylori products, and foodborne products. Sales of C. difficile products decreased 17%. For the six-month period, sales for our Life Science operating segment increased 14%. Our consolidated operating income and net earnings decreased 1% and 3%, respectively, for the first six months of fiscal 2010 compared to the same period of the prior year.
Group Purchasing Organizations
In our US Diagnostics operating segment, consolidation of the US healthcare industry over the last several years has led to the creation of group purchasing organizations (GPOs) 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 first six months of fiscal 2010, we have experienced approximately $1,200 in unfavorable price variance as a result of these agreements. However, these agreements help secure our products with these customers and have led to approximately $1,100 in favorable volume variance. While in the near term this has negatively impacted gross profit, further increases in volumes are expected from these contracts.

 

Page 13


Table of Contents

Upper Respiratory Products
The novel A (H1N1) influenza outbreak in the Northern hemisphere created an early start to the 2009-2010 influenza season. This outbreak continued into the first quarter of our fiscal 2010 and came to an abrupt end in December 2009. For our US Diagnostics operating segment, sales of influenza products comprised 24% and 2% of total US Diagnostics sales for the first and second quarters of fiscal 2010, respectively. The level of inventories at our US distributors, combined with a mild influenza season, resulted in very weak sales of influenza products during the second quarter of fiscal 2010.
The novel A (H1N1) influenza pandemic also created an increased interest in influenza testing in European markets where rapid testing has not been traditionally performed, resulting in sales growth of approximately 23% in this operating segment on an organic basis (excluding currency) for the first six months of fiscal 2010 for this product family. Similar to US markets, sales of influenza products declined during the second quarter of fiscal 2010.
We expect minimal influenza product sales during the remainder of our fiscal year, in light of both the end of the outbreak and current inventory levels at our US distributors.
Foodborne Products
During the first six months of fiscal 2010, sales of our Foodborne products grew approximately 20% for our US Diagnostics operating segment and 30%+ for our European Diagnostics operating segment on an organic basis. We continue to see volume growth coming from new products launched over the last few fiscal years (ImmunoCard STAT!® EHEC launched in fiscal 2007, and PremierTM CAMPY and ImmunoCard STAT!® CAMPY launched in fiscal 2009).
C. difficile Products
Sales of C. difficile products decreased 29% for all of our Diagnostics operating segments during the first quarter of fiscal 2010 and were flat during the second quarter of fiscal 2010 compared to the same periods of the prior year.
Sales of C. difficile products for our US Diagnostics operating segment were impacted by distributor buying patterns during the first two quarters of fiscal 2009, when one of our distributors stocked higher than normal inventory levels in advance of our January 1st price increase and decreased purchases during the second quarter. This distributor stocked normal inventory levels for our C. difficile products during fiscal 2010.
The C. difficile market also continues to experience considerable confusion around the relative benefits of the various test methods available (toxin testing, antigen testing and molecular testing). Several new competitive products, including molecular assays, have been introduced into this market, causing competitive pressures for our products. These competitive factors resulted in significant sales declines in both of our diagnostic operating segments.
We expect to combat the competitive pressures in this disease family with our strong position in toxin testing and the launch of our illumigeneTM molecular C. difficile product. Our new molecular test for C. difficile on our illumigeneTM platform has been submitted to the FDA for marketing clearance. Revenue contributions from the launch of this technology began during April 2010 in markets outside the US.
H. pylori Products
During each of the first two quarters of fiscal 2010, sales of our H. pylori products grew 10%+ for our US Diagnostics operating segment and 3% for our European Diagnostics operating segment on an organic basis. Although the sales growth rate for our US Diagnostics operating segment reflects a level of buying pattern difference in our national reference lab customer base, our partnerships with managed care companies in promoting the health and economic benefits of a test and treat strategy is beginning to move physician behavior away from serology-based testing to direct antigen testing.
Life Science
Sales for our Life Science operating segment increased 6% for the first quarter of fiscal 2010 and 22% for the second quarter of fiscal 2010, with an increase for the first six months of fiscal 2010 of 14%. This increase reflects growth from our two largest diagnostic manufacturing customers. We continue to expect high single-digit growth for this operating segment during the remainder of fiscal 2010.

 

Page 14


Table of Contents

Significant Customers
Two national distributors in our US Diagnostics operating segment accounted for 48% and 50% of total sales for this operating segment for the second quarters of fiscal 2010 and 2009, respectively, and 61% and 56% of total sales for this operating segment for the first six months of fiscal 2010 and 2009, respectively. The fluctuations in percentage of sales during the second quarter and six month periods of fiscal 2010 reflect inventory stocking of influenza and other products during the first quarter and other products for these national distributors.
Two diagnostic manufacturing customers in our Life Science operating segment accounted for 31% and 25% of total sales for this operating segment for the second quarters of fiscal 2010 and 2009, respectively, and 32% and 28% of total sales for this operating segment for the first six months of fiscal 2010 and 2009, respectively.
Foreign Currency
Sales growth for our European Diagnostics operating segment included the effect of more favorable currency rates in the amount of approximately $900 for the first six months of fiscal 2010. Sales for this operating segment decreased 2% on an organic basis for the first six months of fiscal 2010.
Operating Segment Revenues
Our reportable operating segments are US Diagnostics, European Diagnostics, and Life Science. The US Diagnostics operating segment consists of manufacturing operations in Cincinnati, Ohio, and the sale and distribution of diagnostic test kits in North America, South America and the Pacific Rim. The European Diagnostics operating segment consists of the sale and distribution of diagnostic test kits in Europe, Scandinavia, Africa, and the Middle East. The Life Science operating segment consists of manufacturing operations in Memphis, Tennessee, Saco, Maine, and Boca Raton, Florida, and the sale and distribution of bulk antigens, antibodies and bioresearch reagents domestically and abroad. 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.

 

Page 15


Table of Contents

Revenues for our each of our operating segments are shown below.
                                                 
    Three Months Ended March 31     Six Months Ended March 31  
    2010     2009     Inc (Dec)     2010     2009     Inc (Dec)  
US Diagnostics
  $ 18,193     $ 21,461       -15 %   $ 48,897     $ 44,946       +9 %
European Diagnostics
    6,591       6,599       %     12,885       12,270       +5 %
Life Science
    6,363       5,220       +22 %     11,822       10,357       +14 %
 
                                   
Consolidated
  $ 31,147     $ 33,280       -6 %   $ 73,604     $ 67,573       +9 %
 
                                   
 
                                               
International -
                                               
US Export
  $ 1,248     $ 1,599       -22 %   $ 2,977     $ 2,696       +10 %
Life Science Export
    2,792       2,117       +32 %     5,252       4,487       +17 %
European Diagnostics
    6,591       6,599       %     12,885       12,270       +5 %
 
                                   
Total
  $ 10,631     $ 10,315       +3 %   $ 21,114     $ 19,453       +9 %
 
                                   
% of total sales
    34 %     31 %             29 %     29 %        
 
                                   
Gross Profit
                                                 
    Three Months Ended March 31,     Six Months Ended March 31,  
    2010     2009     Inc (Dec)     2010     2009     Inc (Dec)  
Gross Profit
  $ 20,167     $ 20,974       -4 %   $ 45,652     $ 44,318       +3 %
 
                                               
Gross Profit Margin
    65 %     63 %   +2 points %     62 %     66 %   -4 points %
Gross profit margin for the first six months of fiscal 2010 was negatively impacted by the strong mix of Upper Respiratory sales during the first quarter of fiscal 2010. With the end of the H1N1 influenza pandemic in December 2009, sales mix shifted in favor of our other product families in the second quarter, showing an increase of 5 points in gross profit margin from 60% in the first quarter to 65% in the second quarter.
As we move forward, we expect that our internally developed and manufactured TRU FLU® and TRU RSV® products will improve overall gross profit margins for the Upper Respiratory product family, as these products now represent in excess of 40% of total influenza and respiratory syncytial virus product sales for our US Diagnostics operating segment.
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 and antibodies, 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.

 

Page 16


Table of Contents

Operating Expenses
                                                                 
    Three months ended March 31     Six months ended March 31  
                            Total                             Total  
    Research &     Sales &     General &     Operating     Research &     Sales &     General &     Operating  
    Development     Marketing     Administrative     Expenses     Development     Marketing     Administrative     Expenses  
2009 Expenses
  $ 2,339     $ 3,975     $ 3,655     $ 9,969     $ 4,403     $ 8,942     $ 7,810     $ 21,155  
 
                                               
% of Sales
    7 %     12 %     11 %     30 %     7 %     13 %     12 %     31 %
 
                                                               
Fiscal 2010 Increases (Decreases):
                                                               
US Diagnostics
    (221 )     247       476       502       (326 )     241       1,089       1,004  
European Diagnostics
          16       119       135             (16 )     156       140  
 
Life Science
    197       83       156       436       316       41       115       472  
 
                                               
 
                                                               
2010 Expenses
  $ 2,315     $ 4,321     $ 4,406     $ 11,042     $ 4,393     $ 9,208     $ 9,170     $ 22,771  
 
                                               
% of Sales
    7 %     14 %     14 %     35 %     6 %     13 %     12 %     31 %
% Increase (Decrease)
    -1 %     +9 %     +21 %     +11 %   $ %     +3 %     +17 %     +8 %
We continue to closely control spending for each of our operating segments.
Research and development expenses for the US Diagnostics operating segment decreased for the second quarter and the six-month period primarily due to development costs for our molecular illumigeneTM C. difficile product in fiscal 2009. This product has been submitted to the FDA for marketing clearance. Expenses related to clinical trials in fiscal 2009 for immunoassay products also contributed to these decreases, which were to some extent offset by increased salaries and benefits for planned headcount additions. Research and development expenses for the Life Science operating segment increased for the second quarter and six-month period primarily due to increased salaries and benefits related to filling of open positions and decreased research and development resource allocations between new product development and contract research and development performed for customers under contracts.
Selling and marketing expenses for the US Diagnostics operating segment increased for the second quarter and the six-month period primarily due to costs related to the launch of our new molecular illumigeneTM C. difficile product in fiscal 2010 and outside marketing, partially offset by decreased sales bonus expense in fiscal 2010.
The increase in general and administrative expenses for our US Diagnostics operating segment relates primarily to increased compensation costs and includes stock based compensation costs related to a time-vested restricted stock grant in November 2009. During the second quarter of 2009, accruals for corporate incentive bonus related to the first quarter of 2009 were reversed, causing bonus expense to be negative for the quarter. During the second quarter of 2010, no corporate incentive bonus was accrued. Accordingly, bonus expense was higher for the 2010 period.
Operating Income
Operating income decreased 17% to $9,125 for the second quarter of fiscal 2010 and decreased 1% to $22,881 for the first six months of fiscal 2010, as a result of the factors discussed above.
Other Income and Expense
Interest income decreased 64% for the second quarter of fiscal 2010 and 82% for the first six months of fiscal 2010 compared to the same periods of the prior fiscal year. This decrease was driven by lower interest yields due to a higher concentration of investments in money market funds in fiscal 2010 and lower interest rates in the current interest rate environment.

 

Page 17


Table of Contents

Income Taxes
The effective rate for income taxes was 35% for the second quarters and the first six months of both fiscal 2010 and 2009. For the fiscal year ending September 30, 2010, Meridian expects the effective tax rate to be approximately 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 contains overnight repurchase agreements, institutional money-market mutual funds, municipal debt obligations and tax-exempt auction-rate securities.
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 a result of conditions in the financial markets, we have chosen to keep the maturity of our investment portfolio very short. 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, 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. We intend to continue to fund our working capital requirements and dividends from current cash flows from operating activities. We also have additional sources of liquidity through our investment portfolio and a $30,000 bank credit facility, if needed. To date, 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. 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 collectability of our customer accounts receivable, or impact credit terms with our vendors, or disrupt the supply of raw materials and services.
Net cash provided by operating activities increased 31% for the first six months of fiscal 2010 to $16,629, despite decreases in net earnings. This increase was primarily attributable to net working capital changes related to fluctuations in sales levels. Net cash flows from operating activities are anticipated to be adequate to fund working capital requirements, capital expenditures and dividends during the next 12 months.
Capital Resources
We have a $30,000 credit facility with a commercial bank which expires on September 15, 2012. As of April 30, 2010, 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 six months of fiscal 2010, or during the full year of fiscal 2009.
Our capital expenditures are estimated to be approximately $5,000 for fiscal 2010 and may be funded with operating cash flows, availability under the $30,000 credit facility, or cash and investments on-hand. Capital expenditures relate to manufacturing and other equipment of a normal and recurring nature, the build out of the recently purchased property in the Village of Newtown, Ohio, and an expansion of our Memphis, Tennessee manufacturing facility.
We do not utilize any special-purpose financing vehicles or have any undisclosed off balance sheet arrangements.

 

Page 18


Table of Contents

Other
Healthcare Legislation
In March 2010, the Patient Protection and Affordable Health Care Act of 2009 was signed into law by the president and the Health Care and Education Affordability Reconciliation Act of 2010 was passed by the House of Representatives. This legislation establishes a 2.3% excise tax on the sales of medical devices that retail for more than one hundred dollars beginning in 2013. At existing sales levels in our US markets, this would result in an annual excise tax in excess of $2,000 for our company. It is unknown at the present time whether this cost can be passed on to customers.
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, 2009.
ITEM 4.  
CONTROLS AND PROCEDURES
As of March 31, 2010, 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 March 31, 2010. 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 first 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 March 31, 2010.
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 4.  
SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
Meridian’s Annual Meeting of Shareholders was held on January 21, 2010. Each of the following matters was voted upon and approved by Meridian’s shareholders as indicated below:
(1)  
Election of the following six directors:
   
James M. Anderson, 30,043,397 votes for, 292,999 votes withheld, 22,525 abstentions, and 6,077,337 broker non-votes.
   
James A. Buzard, 26,387,455 votes for, 3,946,375 votes withheld, 25,090 abstentions, and 6,077,338 broker non-votes.
   
John A. Kraeutler, 29,171,499 votes for, 1,168,909 votes withheld, 18,513 abstentions, and 6,077,337 broker non-votes.
   
Gary P. Kreider, 25,417,792 votes for, 4,925,285 votes withheld, 15,843 abstentions, and 6,077,338 broker non-votes.
   
William J. Motto, 28,771,305 votes for, 1,570,600 votes withheld, 17,015 abstentions and 6,077,338 broker non-votes.
   
David C. Phillips, 29,542,886 votes for, 800,410 votes withheld, 15,624 abstentions and 6,077,338 broker non-votes.
   
Robert J. Ready, 28,961,810 votes for, 1,381,935 votes withheld, 15,174 abstentions, and 6,077,339 broker non-votes.
(2)  
Ratification of the appointment of Grant Thornton LLP as Meridian’s independent registered public accounting firm for fiscal 2010: 36,291,603 votes for, 53,113 votes against, and 91,542 abstentions.

 

Page 19


Table of Contents

ITEM 6.  
EXHIBITS
     
31.1 —  
Certification of Principal Executive Officer Pursuant to Securities Exchange Act Rule 13a-14(a)/15d-14(a)
   
 
31.2 —  
Certification of Principal Financial Officer Pursuant to Securities Exchange Act Rule 13a-14(a)/15d-14(a)
   
 
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

 

Page 20


Table of Contents

SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
         
 
  MERIDIAN BIOSCIENCE, INC.    
 
       
Date: May 7, 2010
  /s/ Melissa Lueke
 
Melissa Lueke
   
 
  Executive Vice President and
Chief Financial Officer
   

 

Page 21