SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

Form10-Q

 

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

For the Quarterly Period Ended March 31,June 30, 2016

OR

 

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

For the transition period from                    to                    

Commission file 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.    Yes  x    No  ¨

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).    Yes  x    No  ¨

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See 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 ¨
Non-accelerated filer ¨  Smaller reporting company ¨

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).    Yes  ¨    No  x

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,July 31, 2016

Common Stock, no par value 42,074,80242,086,737


MERIDIAN BIOSCIENCE, INC. AND SUBSIDIARIES

TABLE OF CONTENTS TO QUARTERLY REPORT ON FORM10-Q

 

      Page(s) 
PART I.  FINANCIAL INFORMATION  
Item 1.  

Financial Statements (Unaudited)

Condensed Consolidated Statements of Operations Three and SixNine Months Ended March 31,June 30, 2016 and 2015

   1  
  

Condensed Consolidated Statements of Comprehensive Income Three and SixNine Months Ended March 31,June 30, 2016 and 2015

   2  
  

Condensed Consolidated Statements of Cash Flows SixNine Months Ended March 31,June 30, 2016 and 2015

   3  
  

Condensed Consolidated Balance Sheets March 31,June 30, 2016 and September 30, 2015

   4-5  
  

Condensed Consolidated Statement of Changes in Shareholders’ Equity SixNine Months Ended March 31,June 30, 2016

   6  
  

Notes to Condensed Consolidated Financial Statements

   7-127-13  
Item 2.  Management’s Discussion and Analysis of Financial Condition and Results of Operations   13-2114-21  
Item 3.  Quantitative and Qualitative Disclosures About Market Risk   21  
Item 4.  Controls and Procedures   21  
PART II.  OTHER INFORMATION  
Item 1A.  Risk Factors   22  
Item 5.Other Information22
Item 6.  Exhibits   22  
Signature     23  

FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q contains forward-looking statements. 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. All statements that address operating performance or events or developments that Meridian expects or anticipates will occur in the future, including, but not limited to, statements relating to per share diluted earnings and revenue, are forward-looking statements. Such statements, whether expressed or implied, are based upon current expectations of the Company and speak only as of the date made. Specifically, Meridian’s forward-looking statements are, and will be, based on management’s then-current views and assumptions regarding future events and operating performance. Meridian 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, and its ability to effectively sell such products. 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. The 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 impact results and make them difficult to predict. One of Meridian’s 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. Meridian cannot predict the possible impact of U.S. health care legislation enacted in 2010 – the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act – and any modification or repeal of any of the provisions thereof, and any similar initiatives in other countries on its results of operations. Efforts to reduce the U.S. federal deficit, breaches of Meridian’s information technology systems and natural disasters and other events could have a materially adverse effect on Meridian’s results of operations and revenues. 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
March 31,
 Six Months Ended
March 31,
  Three Months Ended
June 30,
 Nine Months Ended
June 30,
 
  2016 2015 2016 2015  2016 2015 2016 2015 

NET REVENUES

  $51,259   $51,545   $98,419   $99,558   $50,665   $48,204   $149,084   $147,762  

COST OF SALES

   17,687   19,024   33,264   37,800   17,756   17,873   51,020   55,673  
  

 

  

 

  

 

  

 

  

 

  

 

  

 

  

 

 

GROSS PROFIT

   33,572   32,521   65,155   61,758   32,909   30,331   98,064   92,089  
  

 

  

 

  

 

  

 

  

 

  

 

  

 

  

 

 

OPERATING EXPENSES

         

Research and development

   3,129   3,368   6,510   6,471   3,546   3,214   10,056   9,685  

Selling and marketing

   7,210   6,481   13,653   12,561   8,085   6,184   21,738   18,745  

General and administrative

   6,875   6,940   14,769   14,325   7,537   6,535   22,306   20,860  

Transaction costs

   1,202    —     1,481    —    

Acquisition-related costs

  —      —     1,481    —    
  

 

  

 

  

 

  

 

  

 

  

 

  

 

  

 

 

Total operating expenses

   18,416   16,789   36,413   33,357   19,168   15,933   55,581   49,290  
  

 

  

 

  

 

  

 

  

 

  

 

  

 

  

 

 

OPERATING INCOME

   15,156   15,732   28,742   28,401   13,741   14,398   42,483   42,799  

OTHER INCOME (EXPENSE)

         

Interest income

   3   6   20   12   22   6   42   18  

Interest expense

   (43  —     (43  —     (427  —     (470  —    

Other, net

   (324 (211 (228 (793 65   (99 (163 (892
  

 

  

 

  

 

  

 

  

 

  

 

  

 

  

 

 

Total other income (expense)

   (364 (205 (251 (781 (340 (93 (591 (874
  

 

  

 

  

 

  

 

  

 

  

 

  

 

  

 

 

EARNINGS BEFORE INCOME TAXES

   14,792   15,527   28,491   27,620   13,401   14,305   41,892   41,925  

INCOME TAX PROVISION

   5,701   5,457   10,507   9,649   4,647   5,203   15,154   14,852  
  

 

  

 

  

 

  

 

  

 

  

 

  

 

  

 

 

NET EARNINGS

  $9,091   $10,070   $17,984   $17,971   $8,754   $9,102   $26,738   $27,073  
  

 

  

 

  

 

  

 

  

 

  

 

  

 

  

 

 

BASIC EARNINGS PER COMMON SHARE

  $0.22   $0.24   $0.43   $0.43   $0.21   $0.22   $0.64   $0.65  

DILUTED EARNINGS PER COMMON SHARE

  $0.21   $0.24   $0.42   $0.43   $0.21   $0.22   $0.63   $0.64  

WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING - BASIC

   42,053   41,707   41,984   41,636   42,076   41,714   42,000   41,647  

EFFECT OF DILUTIVE STOCK OPTIONS AND RESTRICTED SHARES AND UNITS

   372   341   376   336   387   379   379   352  
  

 

  

 

  

 

  

 

  

 

  

 

  

 

  

 

 

WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING - DILUTED

   42,425   42,048   42,360   41,972   42,463   42,093   42,379   41,999  
  

 

  

 

  

 

  

 

  

 

  

 

  

 

  

 

 

ANTI-DILUTIVE SECURITIES:

         

Common share options and restricted shares and units

   444   570   476   546   465   493   449   567  
  

 

  

 

  

 

  

 

  

 

  

 

  

 

  

 

 

DIVIDENDS DECLARED PER COMMON SHARE

  $0.20   $0.20   $0.40   $0.40   $0.20   $0.20   $0.60   $0.60  
  

 

  

 

  

 

  

 

  

 

  

 

  

 

  

 

 

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

 

Page 1


MERIDIAN BIOSCIENCE, INC. AND SUBSIDIARIES

Condensed Consolidated Statements of Comprehensive Income (Unaudited)

(in thousands)

 

  Three Months Ended
March 31,
 Six Months Ended
March 31,
   Three Months Ended
June 30,
   Nine Months Ended
June 30,
 
  2016 2015 2016 2015   2016 2015   2016 2015 

NET EARNINGS

  $9,091   $10,070   $17,984   $17,971    $8,754   $9,102    $26,738   $27,073  

Other comprehensive income (loss):

           

Foreign currency translation adjustment

   (78 (2,138 (865 (3,503   (1,563 1,357     (2,479 (2,146

Unrealized loss on cash flow hedge

   (694  —     (694  —       (417  —       (1,111  —    

Income taxes related to items of other comprehensive income

   243    —     243    —       228    —       522    —    
  

 

  

 

  

 

  

 

   

 

  

 

   

 

  

 

 

Other comprehensive income (loss), net of tax

   (529 (2,138 (1,316 (3,503   (1,752 1,357     (3,068 (2,146
  

 

  

 

  

 

  

 

   

 

  

 

   

 

  

 

 

COMPREHENSIVE INCOME

  $8,562   $7,932   $16,668   $14,468    $7,002   $10,459    $23,670   $24,927  
  

 

  

 

  

 

  

 

   

 

  

 

   

 

  

 

 

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

 

Page 2


MERIDIAN BIOSCIENCE, INC. AND SUBSIDIARIES

Condensed Consolidated Statements of Cash Flows (Unaudited)

(in thousands)

 

Six Months Ended March 31,

  2016 2015 

Nine Months Ended June 30,

  2016 2015 

CASH FLOWS FROM OPERATING ACTIVITIES

      

Net earnings

  $17,984   $17,971    $26,738   $27,073  

Non-cash items included in net earnings:

      

Depreciation of property, plant and equipment

   1,785   1,832     2,871   2,585  

Amortization of intangible assets

   762   900     1,834   1,309  

Amortization of deferred instrument costs

   544   754     829   1,088  

Stock-based compensation

   2,290   1,954     2,654   2,676  

Deferred income taxes

   (306 (257   (753 (270

Losses on long-lived assets

   659    —       659   39  

Change in current assets, net of acquisition

   (6,905 (6,910   (9,556 (4,399

Change in current liabilities, net of acquisition

   1,505   3,368     868   796  

Other, net

   143   419     (140 299  
  

 

  

 

   

 

  

 

 

Net cash provided by operating activities

   18,461   20,031     26,004   31,196  
  

 

  

 

   

 

  

 

 

CASH FLOWS FROM INVESTING ACTIVITIES

      

Purchase of property, plant and equipment

   (1,524 (2,561   (2,688 (3,783

Purchase of equity method investment

   (600  —       (600  —    

Acquisition of Magellan, net of cash received

   (62,177  —    

Purchase of intangible assets

   (16  —    

Proceeds from sale of assets

   —     1,138  

Acquisition of Magellan, net of cash acquired

   (62,090  —    
  

 

  

 

   

 

  

 

 

Net cash used for investing activities

   (64,317 (2,561   (65,378 (2,645
  

 

  

 

   

 

  

 

 

CASH FLOWS FROM FINANCING ACTIVITIES

      

Dividends paid

   (16,817 (16,671   (25,233 (25,014

Proceeds from term loan, net of issuance costs

   59,842    —       59,851    —    

Payment on term loan

   (750  —    

Proceeds and tax benefits from exercises of stock options

   1,969   654     2,033   654  
  

 

  

 

   

 

  

 

 

Net cash provided by (used for) financing activities

   44,994   (16,017   35,901   (24,360
  

 

  

 

   

 

  

 

 

Effect of Exchange Rate Changes on Cash and Equivalents

   (165 (1,781   (697 (1,263
  

 

  

 

   

 

  

 

 

Net Decrease in Cash and Equivalents

   (1,027 (328

Net (Decrease) Increase in Cash and Equivalents

   (4,170 2,928  

Cash and Equivalents at Beginning of Period

   49,973   43,047     49,973   43,047  
  

 

  

 

   

 

  

 

 

Cash and Equivalents at End of Period

  $48,946   $42,719    $45,803   $45,975  
  

 

  

 

   

 

  

 

 

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

 

Page 3


MERIDIAN BIOSCIENCE, INC. AND SUBSIDIARIES

Condensed Consolidated Balance Sheets

(in thousands)

ASSETS

 

  March 31,
2016
(Unaudited)
   September 30,
2015
   June 30,
2016

(Unaudited)
   September 30,
2015
 

CURRENT ASSETS

        

Cash and equivalents

  $48,946    $49,973    $45,803    $49,973  

Accounts receivable, less allowances of $320 and $248

   32,450     26,254  

Accounts receivable, less allowances of $341 and $248

   31,312     26,254  

Inventories

   41,934     35,817     43,409     35,817  

Prepaid expenses and other current assets

   4,866     7,378     6,396     7,378  
  

 

   

 

   

 

   

 

 

Total current assets

   128,196     119,422     126,920     119,422  
  

 

   

 

   

 

   

 

 

PROPERTY, PLANT AND EQUIPMENT, at Cost

        

Land

   987     986     984     986  

Buildings and improvements

   30,870     30,056     32,042     30,056  

Machinery, equipment and furniture

   45,009     41,541     45,893     41,541  

Construction in progress

   1,223     1,139     1,824     1,139  
  

 

   

 

   

 

   

 

 

Subtotal

   78,089     73,722     80,743     73,722  

Less: accumulated depreciation and amortization

   47,906     46,230     50,670     46,230  
  

 

   

 

   

 

   

 

 

Net property, plant and equipment

   30,183     27,492     30,073     27,492  
  

 

   

 

   

 

��  

 

 

OTHER ASSETS

        

Goodwill

   64,457     22,349     63,698     22,349  

Other intangible assets, net

   32,602     5,931     31,384     5,931  

Restricted cash

   1,000     1,000     1,000     1,000  

Deferred instrument costs, net

   1,567     1,750     1,503     1,750  

Deferred income taxes

   —       4,954     —       4,954  

Other assets

   356     384     368     384  
  

 

   

 

   

 

   

 

 

Total other assets

   99,982     36,368     97,953     36,368  
  

 

   

 

   

 

   

 

 

TOTAL ASSETS

  $258,361    $183,282    $254,946    $183,282  
  

 

   

 

   

 

   

 

 

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

 

Page 4


MERIDIAN BIOSCIENCE, INC. AND SUBSIDIARIES

Condensed Consolidated Balance Sheets

(dollars in thousands)

LIABILITIES AND SHAREHOLDERS’ EQUITY

 

  March 31,
2016

(Unaudited)
 September 30,
2015
   June 30,
2016

(Unaudited)
 September 30,
2015
 

CURRENT LIABILITIES

      

Accounts payable

  $7,891   $6,646    $7,386   $6,646  

Accrued employee compensation costs

   5,888   5,132     5,425   5,132  

Other accrued expenses

   3,680   2,587     2,558   2,587  

Current portion of long-term debt

   3,000    —       3,375    —    

Income taxes payable

   807   886     1,504   886  
  

 

  

 

   

 

  

 

 

Total current liabilities

   21,266   15,251     20,248   15,251  
  

 

  

 

   

 

  

 

 

NON-CURRENT LIABILITIES

      

Acquisition consideration payable

   2,198    —    

Acquisition consideration

   2,198    —    

Non-current compensation liabilities

   2,204   2,158     2,252   2,158  

Interest rate swap liability

   694    —       1,111    —    

Long-term debt

   56,842    —       55,726    —    

Deferred income taxes

   5,311    —       4,558    —    
  

 

  

 

   

 

  

 

 

Total non-current liabilities

   67,249   2,158     65,845   2,158  
  

 

  

 

   

 

  

 

 

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, 42,074,542 and 41,838,399 shares issued, respectively

   —      —    

Common shares, no par value; 71,000,000 shares authorized, 42,078,657 and 41,838,399 shares issued, respectively

   —      —    

Additional paid-in capital

   121,273   117,151     121,694   117,151  

Retained earnings

   52,219   51,052     52,557   51,052  

Accumulated other comprehensive income

   (3,646 (2,330

Accumulated other comprehensive loss

   (5,398 (2,330
  

 

  

 

   

 

  

 

 

Total shareholders’ equity

   169,846   165,873     168,853   165,873  
  

 

  

 

   

 

  

 

 

TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY

  $258,361   $183,282    $254,946   $183,282  
  

 

  

 

   

 

  

 

 

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

 

Page 5


MERIDIAN BIOSCIENCE, INC. AND SUBSIDIARIES

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

(dollars and shares in thousands)

 

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

Balance at September 30, 2015

   41,838    $117,151    $51,052   $(2,330 $165,873     41,838    $117,151    $51,052   $(2,330 $165,873  

Cash dividends paid

   —       —       (16,817  —     (16,817   —       —       (25,233  —     (25,233

Exercise of stock options

   121     1,832��    —      —     1,832     125     1,889     —      —     1,889  

Conversion of restricted stock units

   116     —       —      —      —       116     —       —      —      —    

Stock compensation expense

   —       2,290     —      —     2,290     —       2,654     —      —     2,654  

Net earnings

   —       —       17,984    —     17,984     —       —       26,738    —     26,738  

Foreign currency translation adjustment

   —       —       —     (865 (865   —       —       —     (2,375 (2,375

Hedging activity, net of tax

   —       —       —     (451 (451   —       —       —     (693 (693
  

 

   

 

   

 

  

 

  

 

   

 

   

 

   

 

  

 

  

 

 

Balance at March 31, 2016

   42,075    $121,273    $52,219   $(3,646 $169,846  

Balance at June 30, 2016

   42,079    $121,694    $52,557   $(5,398 $168,853  
  

 

   

 

   

 

  

 

  

 

   

 

   

 

   

 

  

 

  

 

 

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

 

Page 6


MERIDIAN BIOSCIENCE, INC. AND SUBSIDIARIES

Notes to Condensed Consolidated Financial Statements

Dollars in Thousands, Except Per Share Amounts

(Unaudited)

 

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 March 31,June 30, 2016, the results of its operations for the three and sixnine month periods ended March 31,June 30, 2016 and 2015, and its cash flows for the sixnine month periods ended March 31,June 30, 2016 and 2015. These statements should be read in conjunction with the consolidated financial statements and footnotes thereto included in the Company’s fiscal 2015 Annual Report on Form 10-K. Financial information as of September 30, 2015 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.

The Company’s Condensed Consolidated Balance Sheet as of March 31,June 30, 2016 includes the condensed balance sheet of Magellan Biosciences, Inc., and its wholly-owned subsidiary Magellan Diagnostics, Inc. (collectively, “Magellan”), as set forth and more fully described in Note 3. Due to the immateriality of the amounts, revenues and expenses related to Magellan for the period owned by the Company (March 24 – March 31, 2016) are excluded from theThe Company’s Condensed Consolidated Statements of Operations for both the three or sixand nine months ended June 30, 2016 include Magellan’s results of operations since the March 31, 2016.24, 2016 date of acquisition.

 

2.Significant Accounting Policies

A summary of the Company’s significant accounting policies is included in Note 1 to the audited consolidated financial statements of the Company’s fiscal 2015 Annual Report on Form 10-K.

 

(a)Recent Accounting Pronouncements –

In May 2014, the FASB issued ASU No. 2014-09,Revenue from Contracts with Customers, which supersedes and replaces nearly all currently-existing U.S. GAAP revenue recognition guidance including related disclosure requirements. This guidance, including any clarification guidance thereon, will be effective for the Company beginning October 1, 2018 (fiscal 2019). The Company has not yet completed its assessment of the impact that adoption of this guidance will have on its financial statements.

In November 2015, the FASB issued ASU 2015-17,Balance Sheet Classification of Deferred Taxes, which simplifies the financial statement presentation of deferred income taxes by requiring that deferred income tax assets and liabilities be classified as noncurrent within a classified statement of financial position. Adoption and implementation of the guidance is not required by the Company until issuance of fiscal 2018 first quarter financial statements. However, due to early adoption being permitted and believing the required presentation results in more useful and comparable information related to our net deferred income taxes, the Company has chosen to adopt the guidance as of December 31, 2015 and retrospectively apply the guidance to the prior period presented. This retrospective application results in $3,431 of deferred income tax assets being reclassified from current assets to non-current assets in the September 30, 2015 balance sheet included herein. Adoption of this guidance did not have an impact on the Company’s consolidated results of operations or cash flows.

 

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In February 2016, the FASB issued ASU 2016-02,Leases, which amends the accounting guidance related to leases. These changes, which are designed to increase transparency and comparability among organizations for both lessees and lessors, include, among other things, requiring recognition of lease assets and liabilities on the balance sheet and disclosing key information about leasing arrangements. Adoption and implementation of the guidance is not required by the Company until the beginning of fiscal 2020, although early adoption is permitted. The Company has not yet completed its assessment of the impact that adoption of this guidance will have on its financial statements.

In March 2016, the FASB issued ASU 2016-09,Improvements to Employee Share-Based Payment Accounting, which amends the accounting for share-based payment transactions. These changes, which are designed for simplification, involve several aspects of the accounting for share-based transactions, including the income tax consequences, classification of awards as either equity or liabilities, and classification on the statement of cash flows. Adoption and implementation of the guidance is not required by the Company until the beginning of fiscal 2018, although early adoption is permitted. The Company has not yet completed its assessment of the impact that adoption of this guidance will have on its financial statements.

Issued but not yet effective accounting pronouncements are not expected to have a material impact on the Condensed Consolidated Financial Statements.

 

(b)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 Magellan

On March 24, 2016, we acquired all of the outstanding common stock of Magellan Biosciences, Inc., and its wholly-owned subsidiary Magellan Diagnostics, Inc. (collectively, “Magellan”), for $67,800,$67,690, utilizing the proceeds from a new $60,000 five-year term loan and cash and equivalents on hand. An amount of the acquisition consideration totaling $2,198 remains payable to the sellers, pending the realization of tax benefits for certain net operating loss carryforwards in future tax returns. Headquartered near Boston, Massachusetts, Magellan is a leading manufacturer of FDA-cleared products for the testing of blood to diagnose lead poisoning in children and adults. Magellan is the leading provider of point-of-care lead testing systems in the U.S.

As a result of the consideration paid exceeding the preliminary fair value of the net assets acquired, goodwill in the amount of $42,730$42,740 was recorded in connection with this acquisition, none of which will be deductible for tax purposes. This goodwill results largely from the addition of Magellan’s complementary customer base and distribution channels, industry reputation in the U.S. as a leader in lead testing, and management talent and workforce.Our Condensed Consolidated Statements of Operations for the three and sixnine months ended March 31,June 30, 2016 include $1,173 of transactionacquisition-related costs related to the Magellan acquisition, which are reflected as Operating Expenses.

In addition to Magellan’s results of operations, which are included in our Condensed Consolidated Statements of Operations for the three and nine months ended June 30, 2016 and reported as part of the Diagnostics operating segment, the consolidated results for the three and nine months ended June 30, 2016 also include:

(i)$154 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 Magellan’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)$759 of general and administrative expenses for the three and nine months, respectively, related to the depreciation of the fair value adjustment to acquired property, plant and equipment, and the amortization of specific identifiable intangible assets recorded on the opening balance sheet including customer relationships, technology, non-compete agreements, and trade names.

 

Page 8


The results of Magellan included in the consolidated results of the Company for the three and nine months ended June 30, 2016 are as follows, reflecting the items noted above but excluding interest expense on the debt secured by Meridian in connection with the transaction:

   Three
Months
Ended
June 30,
2016
   Nine
Months
Ended
June 30,
2016
 

Net Revenues

  $4,752    $4,752  

Net Earnings

  $231    $231  

The recognized preliminary amounts of identifiable assets acquired and liabilities assumed in the acquisition of Magellan are as follows:

 

  PRELIMINARY 
  PRELIMINARY   March 24,
2016

(as initially
reported)
   Measurement
Period
Adjustments
   March 24,
2016

(as adjusted)
 

Fair value of assets acquired -

        

Cash and equivalents

  $3,420    $3,420    $(20  $3,400  

Accounts receivable

   1,700     1,700     —       1,700  

Inventories

   1,400     1,400     —       1,400  

Other current assets

   330     330     10     340  

Property, plant and equipment

   2,790     2,790     (200   2,590  

Goodwill

   42,730     42,730     10     42,740  

Other intangible assets (estimated useful life):

        

Customer relationships (15 years)

   12,630     12,630     —       12,630  

Technology (10 years)

   10,550     10,550     —       10,550  

Non-compete agreements (2 years)

   740     740     —       740  

Trade names (approximate 5 year weighted average)

   3,690     3,690     —       3,690  
  

 

   

 

   

 

   

 

 
   79,980     79,980     (200   79,780  

Fair value of liabilities assumed -

        

Accounts payable and accrued expenses

   1,610     1,610     (20   1,590  

Deferred income tax liabilities

   10,570     10,570     (70   10,500  
  

 

   

 

   

 

   

 

 

Total consideration (including $2,198 accrued to be paid)

  $67,800    $67,800    $(110  $67,690  
  

 

   

 

   

 

   

 

 

As indicated, the allocation of the purchase price and estimated useful lives of property, plant and equipment, and intangible assets shown above isremain preliminary, pending final completion of valuations. We are currently assessing the amount of tax net operating loss carryforwards available to us. Upon completion of this analysis, an amount will be reclassified from goodwill to deferred taxes.

Page 9


The consolidated pro forma results of the combined entities of Meridian and Magellan, had the acquisition date been October 1, 2014, are as follows for the periods indicated:

 

  

Three Months

Ended March 31,

   

Six Months

Ended March 31,

   

Three Months Ended

June 30,

   

Nine Months Ended

June 30,

 
  2016   2015   2016   2015   2016   2015   2016   2015 

Net Revenues

  $54,961    $55,073    $106,057    $106,970    $50,665    $52,255    $156,722    $159,225  

Net Earnings

  $9,658    $9,537    $18,211    $15,781    $8,776    $8,698    $26,194    $25,446  

Diluted Earnings Per Common Share

  $0.23    $0.23    $0.43    $0.38    $0.21    $0.21    $0.62    $0.61  

These pro forma amounts have been calculated by including the results of Magellan, and adjusting the combined results to reflect (i)give effect to the transaction costs incurred byfollowing, as if the Company; (ii) the additional depreciation and amortization that would have been charged assuming the preliminary fair value adjustments to inventory ($154), property, plant and equipment ($550) and identifiable intangible assets ($27,610)acquisition had been appliedconsummated on October 1, 2014; and (iii) the interest expense that would have been incurred on the Company’s $60,000 term note had the borrowing occurred on October 1, 2014, together with the consequential tax effects.

effects thereon:

 

(i)remove the effect of transaction costs incurred by the Company;

Page 9

(ii)reflect the additional depreciation and amortization that would have been charged in connection with the preliminary fair value adjustments to inventory ($154), property, plant and equipment ($366) and identifiable intangible assets ($27,610);


(iii)reflect equity-based awards granted under the Company’s 2012 Stock Incentive Plan to certain Magellan employees in accordance with executed employee agreements, and to certain Meridian employees to reward them for their efforts in connection with the transaction; and

(iv)reflect the interest expense that would have been incurred on the Company’s $60,000 term note.

4.Cash and Equivalents

Cash and equivalents include the following components:

 

  March 31, 2016   September 30, 2015   June 30, 2016   September 30, 2015 
  Cash and
Equivalents
   Other
Assets
   Cash and
Equivalents
   Other
Assets
   Cash and
Equivalents
   Other
Assets
   Cash and
Equivalents
   Other
Assets
 

Overnight repurchase agreements

  $21,727    $—      $25,436    $—      $7,877    $—      $25,436    $—    

Institutional money market funds

   10,010     —       —       —    

Cash on hand -

                

Restricted

   —       1,000     —       1,000     —       1,000     —       1,000  

Unrestricted

   27,219     —       24,537     —       27,916     —       24,537     —    
  

 

   

 

   

 

   

 

   

 

   

 

   

 

   

 

 

Total

  $48,946    $1,000    $49,973    $1,000    $45,803    $1,000    $49,973    $1,000  
  

 

   

 

   

 

   

 

   

 

   

 

   

 

   

 

 

 

Page 10


5.Inventories

Inventories are comprised of the following:

 

  March 31,
2016
   September 30,
2015
   June 30,
2016
   September 30,
2015
 

Raw materials

  $8,378    $7,095    $7,810    $7,095  

Work-in-process

   11,745     10,096     12,432     10,096  

Finished goods - instruments

   2,640     1,890     2,384     1,890  

Finished goods - kits and reagents

   19,171     16,736     20,783     16,736  
  

 

   

 

   

 

   

 

 

Total

  $41,934    $35,817    $43,409    $35,817  
  

 

   

 

   

 

   

 

 

 

6.Intangible Assets

A summary of our acquired intangible assets subject to amortization, as of March 31,June 30, 2016 and September 30, 2015, is as follows:

 

  March 31, 2016   September 30, 2015   June 30, 2016   September 30, 2015 
  Gross
Carrying
Value
   Accumulated
Amortization
   Gross
Carrying
Value
   Accumulated
Amortization
   Gross
Carrying
Value
   Accumulated
Amortization
   Gross
Carrying
Value
   Accumulated
Amortization
 

Manufacturing technologies, core products and cell lines

  $22,055    $11,012    $11,582    $10,906    $21,962    $11,270    $11,582    $10,906  

Trademarks, licenses and patents

   9,965     3,596     6,410     3,296  

Tradenames, licenses and patents

   9,852     3,835     6,410     3,296  

Customer lists and relationships, and supply agreements

   24,531     10,081     12,105     9,964     24,283     10,255     12,105     9,964  

Non-compete agreements

   740     —       —       —       740     93     —       —    
  

 

   

 

   

 

   

 

   

 

   

 

   

 

   

 

 
  $57,291    $24,689    $30,097    $24,166    $56,837    $25,453    $30,097    $24,166  
  

 

   

 

   

 

   

 

   

 

   

 

   

 

   

 

 

The actual aggregate amortization expense for these intangible assets was $374$1,072 and $431$409 for the three months ended March 31,June 30, 2016 and 2015, respectively, and $762$1,834 and $900$1,309 for the sixnine months ended March 31,June 30, 2016 and 2015, respectively. The estimated aggregate amortization expense for these intangible assets for each of the fiscal years through fiscal 2021 is as follows: remainder of fiscal 2016 – $2,106,$987, fiscal 2017 – $4,075,$4,041, fiscal 2018 – $3,869,$3,835, fiscal 2019 – $3,644,$3,609, fiscal 2020 – $3,474$3,445, and fiscal 2021 – $2,578.

$2,576.

 

Page 10


7.Bank Credit Arrangements

In connection with the acquisition of Magellan (see Note 3), on March 22, 2016 the Company entered into a $60,000 five-year term loan with a commercial bank. The term loan requires quarterly principal and interest payments, with interest at a variable rate tied to LIBOR, and a balloon principal payment of $37,500 at the end of five years. Due to the recent execution date of the term loan and interest being determined on a variable rate basis, the fair value of the term loan at March 31,June 30, 2016 approximates the current carrying value reflected in the accompanying Condensed Consolidated Balance Sheet.

In addition, the Company continues to maintain a $30,000 credit facility with the same commercial bank, which expires March 31, 2021. As there were no borrowings outstanding on this credit facility at March 31,June 30, 2016 or September 30, 2015, available borrowings as of both dates totaled $30,000. The term loan and the credit facility are collateralized by the business assets of the Company’s U.S. subsidiaries, and require compliance with financial covenants that limit the amount of debt obligations and require a minimum level of coverage of fixed charges, as defined in the borrowing agreement. We areAs of June 30, 2016, the Company is in compliance with all covenants.

Page 11


In order to limit exposure to volatility in the LIBOR interest rate, the Company and the commercial bank also entered into an interest rate swap that effectively converts the variable interest rate on the term loan to a fixed rate. With an initial notional balance of $60,000, the interest rate swap has been established with critical terms identical to those of the term loan, including (i) notional reduction amounts and dates; (ii) LIBOR settlement rates; (iii) rate reset dates; and (iv) term/maturity. Due to this, the interest swap has been designated as an effective cash flow hedge, with changes in fair value reflected as a separate component of other comprehensive income in the accompanying Condensed Consolidated Statements of Comprehensive Income. At March 31,June 30, 2016, the fair value of the interest rate swap was $694,a liability of $1,111, and is reflected as a non-current liability in the accompanying Condensed Consolidated Balance Sheet. This fair value was determined by reference to a market quote,third party valuation, and is considered a Level 2 input within the fair value hierarchy of valuation techniques.

 

8.Reportable Segment and Major Customers Information

Meridian was formed in 1976 and functions as a fully-integrated research, development, manufacturing, marketing, and sales organization with primary emphasis in the fields of infectious disease (in vitro) and blood lead diagnostics and life science. Our principal businesses are (i) the development, manufacture and distribution of diagnostic test kits primarily for gastrointestinal, viral, respiratory, parasitic infectious diseases, and elevated blood lead levels; and (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 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.manufacturers.

Our reportable segments are Diagnostics and Life Science, both of which are headquartered in Cincinnati, Ohio, which also serves as the Diagnostics segment’s base of manufacturing operations and research and development for infectious disease products. The Diagnostics segment includes the Company’s recent acquisition of Magellan, which is located in Billerica, Massachusetts (near Boston). Its facility includes research, development, manufacturing, marketing, sales, and distribution operations. The Diagnostics segment has sales and distribution facilities for infectious disease diagnostics in the United States, Europe and Australia. The Life Science segment consists of manufacturing operations in Memphis, Tennessee; 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, including sales and business development offices in Singapore and Beijing, China to further pursue growing revenue opportunities in Asia.

Amounts due from two Diagnostics distributor customers accounted for 18%23% and 21% of consolidated accounts receivable at March 31,June 30, 2016 and September 30, 2015, respectively. Revenues from these two distributor customers accounted for 26%25% and 32%35% of the Diagnostics segment third-party revenues during the three months ended March 31,June 30, 2016 and 2015, respectively, and 33%30% and 36% during the sixnine months ended March 31,June 30, 2016 and 2015, respectively. These distributors represented 19% and 24%26% of consolidated revenues for the fiscal 2016 and 2015 secondthird quarters, respectively, and 24%22% and 27% for the respective year-to-date sixnine month periods.

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Within our Life Science segment, two diagnostic manufacturing customers accounted for 18%23% and 16% of the segment’s third-party revenues during the three months ended March 31,June 30, 2016 and 2015, respectively, and 18%20% and 17%16% during the sixnine months ended March 31,June 30, 2016 and 2015, respectively.

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Segment information for the interim periods is as follows:

 

  Diagnostics   Life Science   Eliminations(1)   Total   Diagnostics   Life Science   Eliminations (1)   Total 

Three Months Ended March 31, 2016

        

Three Months Ended June 30, 2016

        

Net revenues -

                

Third-party

  $37,354    $13,905    $—      $51,259    $37,523    $13,142    $—      $50,665  

Inter-segment

   84     387     (471   —       70     201     (271   —    

Operating income

   11,196     4,154     (194   15,156     9,886     3,696     159     13,741  

Goodwill (March 31, 2016)

   43,985     20,472     —       64,457  

Other intangible assets, net (March 31, 2016)

   29,694     2,908     —       32,602  

Total assets (March 31, 2016)

   190,447     68,349     (435   258,361  

Three Months Ended March 31, 2015

        

Goodwill (June 30, 2016)

   43,992     19,706     —       63,698  

Other intangible assets, net (June 30, 2016)

   28,848     2,536     —       31,384  

Total assets (June 30, 2016)

   187,557     67,641     (252   254,946  

Three Months Ended June 30, 2015

        

Net revenues -

                

Third-party

  $38,662    $12,883    $—      $51,545    $36,049    $12,155    $—      $48,204  

Inter-segment

   85     225     (310   —       46     345     (391   —    

Operating income

   12,083     3,596     53     15,732     11,383     3,060     (45   14,398  

Goodwill (September 30, 2015)

   1,250     21,099     —       22,349     1,250     21,099     —       22,349  

Other intangible assets, net (September 30, 2015)

   2,364     3,567     —       5,931     2,364     3,567     —       5,931  

Total assets (September 30, 2015)

   119,939     63,670     (327   183,282     119,939     63,670     (327   183,282  

Six Months Ended March 31, 2016

        

Nine Months Ended June 30, 2016

        

Net revenues -

                

Third-party

  $72,655    $25,764    $—      $98,419    $110,178    $38,906    $—      $149,084  

Inter-segment

   155     754     (909   —       225     955     (1,180   —    

Operating income

   21,526     7,390     (174   28,742     31,412     11,086     (15   42,483  

Six Months Ended March 31, 2015

        

Nine Months Ended June 30, 2015

        

Net revenues -

                

Third-party

  $75,248    $24,310    $—      $99,558    $111,297    $36,465    $—      $147,762  

Inter-segment

   189     522     (711   —       235     867     (1,102   —    

Operating income

   22,367     6,085     (51   28,401     33,750     9,145     (96   42,799  

 

(1)Eliminations consist of inter-segment transactions.

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

 

Page 1213


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

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

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

Quarterly Highlights

As more fully detailed below, the secondthird quarter of fiscal 2016 was highlighted by our March 24, 2016 acquisitionit being the first quarter to include the results of operations of Magellan Biosciences, Inc., and its wholly-owned subsidiary Magellan Diagnostics, Inc. (collectively, “Magellan”)., which we acquired on March 24, 2016. Headquartered near Boston, Massachusetts, Magellan is a leading manufacturer of FDA-cleared products for the testing of blood to diagnose lead poisoning in children and adults. Magellan is the leading provider of point-of-care lead testing systems in the U.S. In addition, during the quarter we commercialized ourillumigene® MalariaMycoplasma Direct product outside ofin the U.S., representing the ninthtenth assay for ourillumigene molecular platform menu.

Three Months Ended March 31,June 30, 2016

Net earnings for the secondthird quarter of fiscal 2016 decreased 10%4% to $9,091,$8,754, or $0.21 per diluted share, from net earnings for the secondthird quarter of fiscal 2015 of $10,070,$9,102, or $0.24$0.22 per diluted share. Reflected within the fiscal 2016 results are transaction costs related to acquisition activity, including the Magellan acquisition ($1,000, or $0.02 per diluted share, net of tax). Consolidated revenues decreased 1%increased 5% to $51,259$50,665 for the secondthird quarter of fiscal 2016 compared to the same period of the prior year and were flat(also up 5% on a constant-currency basis.

Included within the fiscal 2016 second quarter were revenues from ourillumigenemolecular platform of products totaling $9,665, representing a 5% decrease from the fiscal 2015 second quarter. Also contributing to the consolidated revenue decrease were decreased revenues in two of our diagnostic focus product families (C. difficile and foodborne). Serving to substantially offset these decreases were increased revenues in ourH. pylori, respiratory and women’s health & STD focus product families and both of our Life Science segment’s business lines (i.e., molecular components and immunoassay components)basis).

Revenues for the Diagnostics segment for the secondthird quarter of fiscal 2016 decreased 3%increased 4% compared to the secondthird quarter of fiscal 2015 (also down 3%up 4% on a constant-currency basis), composed of a 5% decrease in molecular products and an 8% increase in non-molecular products, reflecting the following for each$4,800 of our focus product families: 10%Magellan revenues. With 15% growth in its immunoassay components business and a 1% decline in our foodborne products, 23% decline in ourC. difficile products, 8% growth in ourH. pylori products, 10% growth in our respiratory products, and 21% growth in our women’s health & STD products. With growth in both its molecular components and immunoassay components business, revenues of our Life Science segment increased by 8% during the secondthird quarter of fiscal 2016 compared to the secondthird quarter of fiscal 2015, increasing 9% on a constant-currency basis.

SixNine Months Ended March 31,June 30, 2016

For the sixnine month period ended March 31,June 30, 2016, net earnings were flat at $17,984,decreased 1% to $26,738, or $0.42$0.63 per diluted share, compared to net earnings for the comparable fiscal 2015 period of $17,971,$27,073, or $0.43$0.64 per diluted share. Reflected within the year-to-date fiscal 2016 results are transaction costs related to acquisition activity, including due diligence and transaction expenses related to the Magellan acquisition ($1,233, or $0.03 per diluted share, net of tax). Consolidated revenues decreasedincreased 1% to $98,419$149,084 for the first sixnine months of fiscal 2016 compared to the same period of the prior year, and were flatincreasing 2% on a constant-currency basis.

Included within the six month year-to-date fiscal 2016 results were revenues from ourillumigenemolecular platform of products totaling $19,501, representing a 3% decrease from the first six months of fiscal 2015. Also contributing to the consolidated revenue decrease were decreased revenues in two of our diagnostic focus product families (C. difficile and foodborne) and flat revenues in our respiratory family of products and our

Page 13


Life Science segment’s molecular components business line. Serving to substantially offset these items were increased revenues in ourH. pylori and women’s health & STD focus product families and our Life Science segment’s immunoassay components business line.

During the first sixnine months of fiscal 2016, revenues for the Diagnostics segment decreased 3%1% from the comparable fiscal 2015 period (also down 3%(flat on a constant-currency basis), reflecting the following for eachcomposed of our focus product families: 11% declinea 4% decrease in our foodborne products, 13% decline in ourC. difficile products, flat revenues in our respiratory products, 13% growth in ourH. pylorimolecular products and 14% growth in our women’s health & STD products.flat non-molecular products revenue, reflecting $4,800 of Magellan revenues. With 12% growth in its immunoassay components business and flat revenuea 1% decline in its molecular components business, revenues of our Life Science segment increased by 6%7% during the first sixnine months of fiscal 2016, increasing 8% on a constant-currency basis.

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 acquisition activity, each of 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 acquisition activity; 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.

   

Three Months

Ended March 31,

   

Six Months

Ended March 31,

 
   2016   2015   2016   2015 

Net Earnings -

        

U.S. GAAP basis

  $9,091    $10,070    $17,984    $17,971  

Transaction costs (1)

   1,000     —       1,233     —    
  

 

 

   

 

 

   

 

 

   

 

 

 

Adjusted earnings

  $10,091    $10,070    $19,217    $17,971  
  

 

 

   

 

 

   

 

 

   

 

 

 

Net Earnings per Basic Common Share -

        

U.S. GAAP basis

  $0.22    $0.24    $0.43    $0.43  

Transaction costs (1)

   0.02     —       0.03     —    
  

 

 

   

 

 

   

 

 

   

 

 

 

Adjusted Basic EPS

  $0.24    $0.24    $0.46    $0.43  
  

 

 

   

 

 

   

 

 

   

 

 

 

Net Earnings per Diluted Common Share -

        

U.S. GAAP basis

  $0.21    $0.24    $0.42    $0.43  

Transaction costs (1)

   0.02     —       0.03     —    
  

 

 

   

 

 

   

 

 

   

 

 

 

Adjusted Diluted EPS (2)

  $0.24    $0.24    $0.45    $0.43  
  

 

 

   

 

 

   

 

 

   

 

 

 

(1)These transaction costs are net of income tax effects of $202 and $248 for the three and six month periods, respectively, which were calculated using the effective tax rates of the jurisdictions in which the costs were incurred.
(2)Net Earnings per Diluted Common Share for the three months ended March 31, 2016 does not sum to the total due to rounding.

 

Page 14


REVENUE OVERVIEW

Below are analyses of the Company’s revenue, provided for each of the following:

 

By Reportable Segment & Geographic Region

 

By Product Platform/Type

By Disease Family (Diagnostics only)

Revenue Overview-Overview – By Reportable Segment & Geographic Region

Our reportable segments are Diagnostics and Life Science. The Diagnostics segment consists of manufacturing operations for infectious disease products in Cincinnati, Ohio and as a result of our recentthe acquisition of Magellan, manufacturing operations for products detecting elevated lead levels of lead in blood in Billerica, Massachusetts (near Boston). These diagnostic test products are sold and distributed in the countries comprising North, Central and South America (the “Americas”); Europe, Middle East and Africa (“EMEA”); and other countries outside of the Americas and EMEA (rest of the world, or “ROW”). The Life Science segment consists of manufacturing operations in Memphis, Tennessee; 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, including sales and business development offices in Singapore and Beijing, China to further pursue growing revenue opportunities in Asia.

Revenues for the Diagnostics segment, 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 segment, in the normal course of business, may be affected from quarter to quarter by buying patterns of major customers and foreign currency exchange rates. We believe that the overall breadth of our product lines serves to reduce the variability in consolidated revenues due to these factors.

 

  Three Months Ended March 31, Six Months Ended March 31,   Three Months Ended June 30, Nine Months Ended June 30, 
  2016 2015 Inc (Dec) 2016 2015 Inc (Dec)   2016 2015 Inc (Dec) 2016 2015 Inc (Dec) 

Diagnostics-

       

Diagnostics -

       

Americas

  $31,864   $32,179   (1)%  $61,979   $63,092   (2)%   $31,885   $30,410   5 $93,864   $93,502   —  

EMEA

   4,882   5,530   (12)%  9,531   10,533   (10)%    4,826   4,651   4 14,357   15,184   (5)% 

ROW

   608   953   (36)%  1,145   1,623   (29)%    812   988   (18)%  1,957   2,611   (25)% 
  

 

  

 

  

 

  

 

  

 

  

 

   

 

  

 

  

 

  

 

  

 

  

 

 

Total Diagnostics

   37,354   38,662   (3)%  72,655   75,248   (3)%    37,523   36,049   4 110,178   111,297   (1)% 
  

 

  

 

  

 

  

 

  

 

  

 

   

 

  

 

  

 

  

 

  

 

  

 

 

Life Science-

       

Life Science -

       

Americas

   6,356   5,910   8 11,459   11,209   2   4,790   5,065   (5)%  16,249   16,274   —  

EMEA

   4,614   5,002   (8)%  9,150   8,760   4   5,977   4,877   23 15,127   13,637   11

ROW

   2,935   1,971   49 5,155   4,341   19   2,375   2,213   7 7,530   6,554   15
  

 

  

 

  

 

  

 

  

 

  

 

   

 

  

 

  

 

  

 

  

 

  

 

 

Total Life Science

   13,905   12,883   8 25,764   24,310   6   13,142   12,155   8 38,906   36,465   7
  

 

  

 

  

 

  

 

  

 

  

 

   

 

  

 

  

 

  

 

  

 

  

 

 

Consolidated

  $51,259   $51,545   (1)%  $98,419   $99,558   (1)%   $50,665   $48,204   5 $149,084   $147,762   1
  

 

  

 

  

 

  

 

  

 

  

 

   

 

  

 

  

 

  

 

  

 

  

 

 

% of total revenues-

       

% of total revenues -

       

Diagnostics

   73 75  74 76    74 75  74 75 

Life Science

   27 25  26 24    26 25  26 25 
  

 

  

 

   

 

  

 

    

 

  

 

   

 

  

 

  

Total

   100 100  100 100    100 100  100 100 
  

 

  

 

   

 

  

 

    

 

  

 

   

 

  

 

  

Ex-Americas

   25 26  25 25    28 26  26 26 
  

 

  

 

   

 

  

 

    

 

  

 

   

 

  

 

  

 

Page 15


Revenue Overview-Overview – By Product Platform/Type

The revenues generated by each of our reportable segments result primarily from the sale of the following segment-specific categories of products:

Diagnostics

 

 1)Molecular tests that operate on ourillumigene platform

 

 2)ImmunoassayNon-molecular tests on multiple technology platforms

Life Science

 

 1)Molecular components

 

 2)Immunoassay components

Revenues for each product platform/type, as well as its relative percentage of segment revenue, are shown below.

 

  Three Months Ended March 31, Six Months Ended March 31,   Three Months Ended June 30, Nine Months Ended June 30, 
  2016 2015 Inc (Dec) 2016 2015 Inc (Dec)   2016 2015 Inc (Dec) 2016 2015 Inc (Dec) 

Diagnostics-

       

Diagnostics -

       

Molecular

  $9,665   $10,192   (5)%  $19,501   $20,100   (3)%   $10,063   $10,550   (5)%  $29,564   $30,650   (4)% 

Immunoassay

   27,689   28,470   (3)%  53,154   55,148   (4)% 

Non-molecular

   27,460   25,499   8 80,614   80,647   —  
  

 

  

 

  

 

  

 

  

 

  

 

   

 

  

 

  

 

  

 

  

 

  

 

 

Total Diagnostics

  $37,354   $38,662   (3)%  $72,655   $75,248   (3)%   $37,523   $36,049   4 $110,178   $111,297   (1)% 
  

 

  

 

  

 

  

 

  

 

  

 

   

 

  

 

  

 

  

 

  

 

  

 

 

Life Science-

       

Life Science -

       

Molecular components

  $5,116   $4,893   5 $9,865   $9,905   —    $5,037   $5,104   (1)%  $14,902   $15,009   (1)% 

Immunoassay components

   8,789   7,990   10 15,899   14,405   10   8,105   7,051   15 24,004   21,456   12
  

 

  

 

  

 

  

 

  

 

  

 

   

 

  

 

  

 

  

 

  

 

  

 

 

Total Life Science

  $13,905   $12,883   8 $25,764   $24,310   6  $13,142   $12,155   8 $38,906   $36,465   7
  

 

  

 

  

 

  

 

  

 

  

 

   

 

  

 

  

 

  

 

  

 

  

 

 

% of Diagnostics revenues-

       

% of Diagnostics revenues -

       

Molecular

   26 26  27 27    27 29  27 28 

Immunoassay

   74 74  73 73 

Non-molecular

   73 71  73 72 
  

 

  

 

   

 

  

 

    

 

  

 

   

 

  

 

  

Total Diagnostics

   100 100  100 100    100 100  100 100 
  

 

  

 

   

 

  

 

    

 

  

 

   

 

  

 

  

% of Life Science revenues-

       

% of Life Science revenues -

       

Molecular components

   37 38  38 41    38 42  38 41 

Immunoassay components

   63 62  62 59    62 58  62 59 
  

 

  

 

   

 

  

 

    

 

  

 

   

 

  

 

  

Total Life Science

   100 100  100 100    100 100  100 100 
  

 

  

 

   

 

  

 

    

 

  

 

   

 

  

 

  

Following is a discussion of the revenues generated by each of these product platforms/types:

Diagnostics Products

illumigene Molecular Platform Products

Revenues for ourillumigene molecular platform of products decreased 5% to $10,000 for the fiscal 2016 third quarter (also 5% in constant-currency), and decreased 4% to $29,600 for the nine month year-to-date period (3% in constant-currency). These decreases reflect the ongoing intense competition within the molecular-based testing market.

We have over 1,500nearly 1,600 customer account placements.placements, adding 25 customers and 35 assays since our last report. Of these account placements, overapproximately 1,300 accounts have completed evaluations and validations and are regularly purchasing product, with the balance of our account placements being in some stage of product evaluation and/or validation. Of our account placements, we have over 400 accounts that are regularly purchasing, evaluating and/or validating two or more assays.

Page 16


We continue to invest in new product development for our molecular testing platform,illumigene. This and this platform now has the following commercialized tests:

 

1.illumigene®C. difficile – commercialized in August 2010

 

2.illumigene® Group BStreptococcus (Group B Strep or GBS) – commercialized in December 2011

 

3.illumigene® Group AStreptococcus (Group A Strep) – commercialized in September 2012

 

Page 16


4.illumigene® Mycoplasma (M. pneumonia;walking pneumonia) – commercialized in June 2013

 

5.illumigene®Bordetella pertussis (whooping cough) – commercialized in March 2014

 

6.illumigene®Chlamydia trachomatis – commercialized outside of U.S. in February 2015

 

7.illumigene®Neisseria gonorrhea – commercialized outside of U.S. in February 2015

 

8.illumigene® HSV 1&2 (Herpes Simplex Virus Type 1 & Type 2) – commercialized outside of U.S. in May 2015; commercialized in U.S. in July 2015

 

9.illumigene® Malaria – commercialized outside of U.S. in February 2016

We have several additionalillumigene tests in development and have a robust pipeline ofillumigene opportunities. We continue to add new assays to ourillumigene platform menu, with our latest being malaria, which was launched in the EMEA region in February 2016.

10.illumigene® Mycoplasma Direct (M. pneumonia;walking pneumonia) – commercialized in June 2016

We believe that the diagnostic testing market is continuing to selectively move away from culture and immunoassay testing to molecular testing for diseases where there is a favorable cost/benefit position for the total cost of health care. While this market is competitive, with molecular companies such as Cepheid and Becton Dickinson, and others such as Quidel, Great Basin, Nanosphere, and Alere, we believe we are well positionedwell-positioned to capitalize on the migration to molecular testing. Our simple, easy-to-use,illumigene platform, with its expanding menu, requires no expensive equipment purchase and little to no maintenance cost. We believe these features, along with its small footprint and the performance of theillumigene assays, makeillumigene an attractive molecular platform to any size hospital or physician office laboratory that runs moderately-complex tests.

ImmunoassayNon-molecular Products

Revenues from our Diagnostics segment’s immunoassaynon-molecular products decreased 3%increased 8% in the secondthird quarter of fiscal 2016 and decreased 4%were flat on a sixnine month year-to-date basis. As describedThese results reflect the addition of Magellan’s revenue, increased revenues in the product discussions below, the quarterlyourH. pylori immunoassay products and year-to-date decreases result primarily from the declinean overall decrease in revenues of our foodborne,C. difficile and respiratoryother immunoassay products, partially offset byproduct lines.

Since the revenue increase in ourH. pylori products.

Life Science Products

During the second quarter of fiscalMarch 24, 2016 acquisition, revenues from our Life Science segment increased 8%, with revenues from molecular componentMagellan’s sales increasing 5% from the comparable fiscal 2015 quarter and revenues from immunoassay component sales increasing 10%. For the first six months of fiscal 2016, revenues from our Life Science segment increased 6%, with flat revenues from molecular component sales comparedproducts to the year-to-date fiscal 2015 period and revenues from immunoassay component sales increasing 10%. Our molecular component business’ growth was negatively impacted by the movementtest for elevated levels of lead in currency exchange rates since the fiscal 2015 periods, with revenues increasing 8% and 4% on a constant-currency basis over the second quarter and first six months of fiscal 2015, respectively. Our Life Science segment continued to benefit from increased sales into China, with such sales totaling approximately $1,000 and $1,500 during the fiscal 2016 second quarter and year-to-date periods, respectively, primarily in the immunoassay components business.

Diagnostics Revenue Overview- By Disease Family

Revenues from our focus families (C. difficile, foodborne,H. pylori, respiratory and women’s health & STD) comprised 78% of our Diagnostics segment’s revenues during both the second quarter of fiscal 2016 and fiscal 2015, comprising 80% and 78% during the first six months of fiscal 2016 and 2015, respectively. Following is a discussion of the revenues generated by each product family:

C. difficile Products

Revenues for ourC. difficile product family decreased 23% to $6,300 for the fiscal 2016 second quarter (22% in constant-currency), and decreased 13% to $13,700 for the six month year-to-date period (12% in constant-currency). Our molecular products now represent approximately 80% of this product category. TheC. difficile test market continues to be highly competitive, with over 10 suppliers in the United States, certain of which choose to compete solely on price.

Page 17


Foodborne Products

Revenues from our foodborne products (EnterohemorrhagicE. coli(EHEC) andCampylobacter),blood have totaled $4,800 – all of which, as previously noted, are immunoassay products, totaled $6,100 duringreflected within Meridian’s results for the fiscal 2016 second quarter, a 10% decrease from the fiscal 2015 second quarter (also 10% in constant-currency). During the sixthree and nine months ended March 31, 2016, foodborneJune 30, 2016. This level of revenues totaled $11,400, an 11% decrease fromreflects a 17% increase over the fiscalthree-month period ended June 30, 2015, year-to-date period (also 11% in constant-currency). Revenues for our foodborne products during fiscal 2016 have been affected by distributor ordering patterns and increased competition. The primary competition for our foodborne products is laboratory culture methods and an immunoassay EHEC shiga toxin test from one of our competitors. We believe that our test offers better workflow, less hands-on time and quicker results, in additionwhich was prior to being fully compliant with CDC-recommended testing methods. More recently, multi-plex gastro-intestinal panels are introducing new competition in this product category.

H. pylori ProductsMeridian ownership.

During the fiscal 2016 secondthird quarter, revenues from ourH. pylori products all of which are immunoassay products, increased 8%1% (also 8%1% in constant-currency) to $8,300.$8,100. These revenues grew 13%9% to $17,000$25,100 during the first sixnine months of fiscal 2016 (15%(10% in constant-currency). These increases continue to reflect the benefits of our partnerships with managed care companies in promoting (i) the health and economic benefits of a test and treat strategy; (ii) changes in policies that discourage the use of traditional serology methods and promote the utilization of active infection testing methods; and (iii) physician behavior movement away from serology-based testing and toward direct antigen testing. A significant amount of theH. pylori product revenues are sales to reference labs, whose buying patterns may not be consistent from period to period. In addition to our managed care strategy, we have also employed bulk-buy sales promotions into selected distribution and laboratory channels as a defensive strategy against potential new competitive product introductions expected later in the year.

The patents for ourH. pylori products are owned by us and expireexpired in May 2016 in the U.S. and will expire in 2017 in countries outside the U.S. We expect competition with respect to ourH. pylori products to increase upon the expiration of these patents in 2016 and 2017 as we currently market the only FDA-cleared test to detectH. pylori antigen in stool samples. Such competition may have an adverse impact on our selling prices for these products, or our ability to retain business at prices acceptable to us, and consequently, adversely affect our future results of operations and liquidity, including revenues and gross profit. In order to mitigate any loss in revenues, upon patent expiration, among other things, we are researching and experimenting with new products (e.g., detection ofH. pylori on molecular platforms) and attempting to secure significant customers under long-term contracts. We are unable to provide any assurances that we will be successful with any mitigation strategy or that any mitigation strategy will prevent an adverse effect on our future results of operations and liquidity, including revenues and gross profit.

Respiratory Products

Total respiratory

Page 17


During the fiscal 2016 third quarter, revenues forfrom our Diagnostics segment increased 10%other immunoassay products (includingC. difficile, foodborne and respiratory) decreased 18% (also 18% in constant-currency) to $6,500$14,400. These revenues decreased 13% to $49,700 during the secondfirst nine months of fiscal 2016 (12% in constant-currency). These decreases result primarily from the effects of continued increased competition, distributor order patterns and the timing of our promotional “stock-and-block” programs in previous periods.

Life Science Products

During the third quarter of fiscal 2016, (also 10% in constant-currency)revenues from our Life Science segment increased 8%, with revenues from molecular component sales decreasing 1% from the comparable fiscal 2015 quarter and remained flat on a six monthrevenues from immunoassay component sales increasing 15%. For the first nine months of fiscal 2016, revenues from our Life Science segment increased 7%, with revenues from molecular component sales decreasing 1% from the year-to-date basis (increased 1% in constant-currency), totaling $12,100 in fiscal 2016. The quarterly2015 period and revenues from immunoassay component sales increasing 12%. Our molecular component business’ growth was primarily experienced in our molecular respiratory products (illumigeneGroup A Strep,illumigeneMycoplasma andillumigenePertussis), while our year-to-date results were significantlynegatively impacted by the success of promotional “stock-and-block” programsmovement in currency exchange rates since the fiscal 2015 periods, with revenues increasing 2% and 3% on a constant-currency basis over the third (influenza)quarter and fourth (Group A strep) quartersfirst nine months of fiscal 2015, that affected buying patternsrespectively. The weaker growth compared to the last several years is primarily due to several large customers delaying orders in the first quarter of fiscal 2016.

Women’s Health & STD Products

Revenuesconnection with their new product launches and recent customer merger activity. Our Life Science segment continued to benefit from our women’s health & STD products, all of which are molecular products, totaled $1,900increased sales into China, with such sales totaling approximately $500 and $2,000 during the second quarter of fiscal 2016, a 21% increase from the fiscal 2016 secondthird quarter (also 21%and year-to-date periods, respectively, primarily in constant-currency). During the six months ended March 31, 2016, revenues from these products totaled $3,600,immunoassay components business; representing an approximate 25% increase of 14% (also 14% in constant-currency). This growth primarily reflectsover the results of our commercialization during fiscal 2015 of three illumigene tests for sexually transmitted diseases (Chlamydia, Gonorrhea and HSV).year-to-date period.

Significant Customers

Revenue concentrations related to certain customers within our Diagnostics and Life Science segments are set forth in Note 8 of the accompanying Condensed Consolidated Financial Statements.

Page 18


Medical Device Tax

On January 1, 2013, the medical device tax established as part of the U.S. health care reform legislation became effective, and as a result, the Company made its first required tax deposit near the end of January 2013. During the first sixnine months of fiscal 2016 and fiscal 2015, the Company recorded approximately $500 and $1,000,$1,500, respectively, of medical device tax expense ($0 and $500 in the secondthird quarters of fiscal 2016 and 2015, respectively), which is reflected as a component of cost of sales in the accompanying Condensed Consolidated Statements of Operations. During December 2015, the Consolidations Appropriations Act of 2016 imposed a two-year moratorium on this excise tax effective January 1, 2016. During calendar years 2016 and 2017, this moratorium would result in approximately $2,000 of savings each year. We are unable to predict any future legislative changes or developments related to this moratorium or excise tax.

Gross Profit

 

  Three Months Ended March 31, Six Months Ended March 31,   Three Months Ended June 30, Nine Months Ended June 30, 
  2016 2015 Change 2016 2015 Change   2016 2015 Change 2016 2015 Change 

Gross Profit

  $33,572   $32,521   3 $65,155   $61,758   6  $32,909   $30,331   8 $98,064   $92,089   6

Gross Profit Margin

   65 63 +2 points   66 62 +4 points     65 63 +2 points   66 62 +4 points  

The overall gross profit increases experienced in fiscal 2016 primarily result from the combined effects of (i) mix of products sold, particularly the higher revenue contribution fromH. pylori products; (ii) realization of manufacturing facility efficiencies for ourillumigene products as a result of bringing in-house certain reagent dispensing operations that were previously outsourced; (iii) manufacturing efficiencies in our Life Science segment; and (iv) favorable effects of currency rates related to products where the purchase cost is denominated in Euros but the customer sales are billed in U.S. dollars.

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, PCR/qPCR reagents, nucleotides, competent cells, proficiency panels, and contract manufacturing services. Product revenue mix shifts, in the normal course of business, can cause the consolidated gross profit margin to fluctuate by several points.

Page 18


Operating Expenses

   Three Months Ended March 31, 2016 
   Research &
Development
  Selling &
Marketing
  General &
Administrative
  Transaction
Costs
  Total Operating
Expenses
 

2015 Expenses

  $3,368   $6,481   $6,940   $—     $16,789  
  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

 

% of Revenues

   7  13  13  —    33

Fiscal 2016 Increases (Decreases):

      

Diagnostics

   (117  302    (223  1,202    1,164  

Life Science

   (122  427    158    —      463  
  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

 

2016 Expenses

  $3,129   $7,210   $6,875   $1,202   $18,416  
  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

 

% of Revenues

   6  14  13  2  36

% Increase (Decrease)

   (7)%   11  (1)%   NMF    10

 

   Three Months Ended June 30, 2016 
   Research &
Development
  Selling &
Marketing
  General &
Administrative
  Acquisition-
Related Costs
  Total Operating
Expenses
 

2015 Expenses

  $3,214   $6,184   $6,535   $—     $15,933  
  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

 

% of Revenues

   7  13  14  —    33

Fiscal 2016 Increases (Decreases):

  

Diagnostics

   389    1,702    1,285    —      3,376  

Life Science

   (57  199    (283  —      (141
  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

 

2016 Expenses

  $3,546   $8,085   $7,537   $—     $19,168  
  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

 

% of Revenues

   7  16  15  —    38

% Increase (Decrease)

   10  31  15  —    20

Page 19


  Six Months Ended March 31, 2016   Nine Months Ended June 30, 2016 
  Research &
Development
 Selling &
Marketing
 General &
Administrative
 Transaction
Costs
 Total Operating
Expenses
   Research &
Development
 Selling &
Marketing
 General &
Administrative
 Acquisition-
Related Costs
 Total Operating
Expenses
 

2015 Expenses

  $6,471   $12,561   $14,325   $—     $33,357    $9,685   $18,745   $20,860   $—     $49,290  
  

 

  

 

  

 

  

 

  

 

   

 

  

 

  

 

  

 

  

 

 

% of Revenues

   6 13 14 —   34   7 13 14 —   33

Fiscal 2016 Increases (Decreases):

      

Fiscal 2016 Increases (Decreases):

  

Diagnostics

   278   331   191   1,481   2,281     667   2,033   1,476   1,481   5,657  

Life Science

   (239 761   253    —     775     (296 960   (30  —     634  
  

 

  

 

  

 

  

 

  

 

   

 

  

 

  

 

  

 

  

 

 

2016 Expenses

  $6,510   $13,653   $14,769   $1,481   $36,413    $10,056   $21,738   $22,306   $1,481   $55,581  
  

 

  

 

  

 

  

 

  

 

   

 

  

 

  

 

  

 

  

 

 

% of Revenues

   7 14 15 2 37   7 15 15 1 37

% Increase

   1 9 3 NMF   9   4 16 7 NMF   13

Total operating expenses increased during both the secondthird quarter of fiscal 2016 and the first sixnine months of fiscal 2016 compared to the corresponding fiscal 2015 periods. These levels of operating expenses result primarily from the combined effects of our (i) ongoing efforts to control spending in eachthe following:

Diagnostics

Quarterly

Addition of our segments while investing the necessary resources in our strategic areas of growth, including increased investment in new product development in our Diagnostics segment (concentrated during the first three monthsMagellan’s operating expenses, which represent approximately 75% of the year),total Diagnostics operating expense increase; and increased

Increased investment in Sales and& Marketing personnelactivities, including the addition of new sales territories.

Year-to-Date

Addition of Magellan’s operating expenses, which represent approximately 45% of the total Diagnostics operating expense increase;

Increased investment in Sales & Marketing activities, including the addition of new sales territories; and programs; (ii) favorable effects of currency rates; and (iii) transaction costs incurred

Costs in connection with acquisition activities, most notably related to the acquisition of Magellan.

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Life Science

Quarterly & Year-to-Date

Increased investment in Sales & Marketing activities, including increased personnel, travel and marketing spending

Operating Income

Operating income decreased 4%5% to $15,156$13,741 for the secondthird quarter of fiscal 2016, and increaseddecreased 1% to $28,742$42,483 for the first sixnine months of fiscal 2016, as a result of the factors discussed above.

Income Taxes

The effective rate for income taxes increased to 39%was 35% and 37% during36% for the third quarters of fiscal 2016 second quarter and six month2015, respectively, and 36% and 35%, respectively, for the nine-month year-to-date periods respectively, compared to 35% in both of the corresponding fiscalended June 30, 2016 and 2015, periods. These increasesrespectively. The year-to-date increase primarily resultresults from the non-deductibility of certain expenses incurred in connection with the Company’s acquisition activities. For the fiscal year ending September 30, 2016, we expect the effective tax rate to approximate 36%-37%35%-36%.

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.

We have an investment policy that guides the holdings of our investment portfolio, which presently consistconsists of overnight repurchase agreements, bank savings accounts and institutional money market mutual funds (beginning in April). Our objectives 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.

On June 23, 2016, the United Kingdom voted to leave the European Union (commonly referred to as “Brexit”) and while the impact of Brexit remains very uncertain, the resulting immediate changes in foreign currency exchange rates has limited overall impact due to natural hedging. However, the predicted deterioration in the United Kingdom and European economic outlook may have an adverse effect on revenue growth, but the extent of such effect cannot yet be quantified. In the longer term, it is highly likely we will be directly impacted in a number of key areas including the hiring and retention of qualified staff, regulatory affairs, manufacturing and logistics. We are closely monitoring the Brexit developments in order to determine, quantify and proactively address changes as they become clear. Despite the Brexit developments, overall we do not expect economic conditions to have a significant impact on our liquidity needs, financial condition or results of 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. If needed, we also have an additional source of liquidity through our $30,000 bank credit facility. Our liquidity needs may

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change if overall economic conditions change and/or liquidity and credit within the financial markets tightens for an extended period of time, and such conditions impact the collectibility 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 totaled $18,461$26,004 for the first sixnine months of fiscal 2016, an 8%a 17% decrease from the $20,031$31,196 provided during the first sixnine months of fiscal 2015. While reflecting the effects of the timing of payments from customers and to customerssuppliers and suppliers, respectively,taxing authorities, this decrease also largely results in large part from the timingincrease in inventory levels. The levels of tax payments.inventory in our Life Science segment have been increased in anticipation of demand related to various initiatives, most notably further expansion into the Asian market. Net cash flows from operating activities and cash on hand are anticipated to be adequate to fund working capital requirements, capital expenditures and dividends during the next 12 months.

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As described in Notes 3 and 7 of the accompanying Condensed Consolidated Financial Statements, on March 24, 2016, the Company acquired all of the outstanding common stock of Magellan for $67,800,$67,690, utilizing the proceeds from a new $60,000 five-year term loan and cash and equivalents on hand. An amount of the acquisition consideration totaling $2,198 remains payable to the sellers, pending the realization of tax benefits for certain net operating loss carryforwards in future tax returns.

Capital Resources

We have a $30,000 credit facility with a commercial bank that expires on March 31, 2021. As of April 30,July 31, 2016, 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 sixnine months of fiscal 2016 or during the full year of fiscal 2015.

Our capital expenditures are estimated to range between approximately $3,000 to $4,000 for fiscal 2016, with the actual amount depending upon actual operating results and the phasing of certain projects. Such expenditures may be funded with cash and equivalents on hand, operating cash flows, and/or availability under the $30,000 credit facility discussed above.

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, 2015.

ITEM 4. CONTROLS AND PROCEDURES

As of March 31,June 30, 2016, 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,June 30, 2016. 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 secondthird fiscal quarter that have materially affected, or are 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,June 30, 2016. We routinely refine our internal controls over financial reporting in the normal course of business as new business activities arise or risks change. These refinements are made under a program of continuous improvement.

 

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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 5. OTHER INFORMATION

Our Board of Directors authorized us to enter into change in control severance agreements with our executive officers (other than our Chief Executive Officer who has change of control provisions in his Employment Agreement), which were executed effective August 4, 2016. Each agreement has an initial term ending December 31, 2016, and each year will automatically renew for an additional one year term, provided however, that if a change in control occurs the term will expire no earlier than 24 calendar months after the calendar month in which such change in control occurs. The change in control severance agreements replace the Company’s change in control policy which was adopted by the Board in March 2011. This agreement is the result of Management’s and the Board’s periodic review and updates of certain policies and practices. A change of control is generally defined in each agreement as any of the following: (i) a person is or becomes a beneficial owner of more than 50% of our voting securities; (ii) the composition of a majority of our Board changes; (iii) we consummate a merger or similar transaction; (iv) the sale of all or substantially all of our assets; or (v) the employment of a Chief Executive Officer other than the Company’s current CEO as of the date of the agreement. Each agreement provides, among other things, that if a change in control occurs during the term of the agreement, and the executive’s employment is terminated either by us or by the executive, other than: (a) by us for cause; (b) by reason of death or disability; or (c) by the executive without good reason, such executive will receive a severance payment equal to: (A) a multiple of such executive’s annual base salary; (B) a multiple of executive’s target bonus amounts; and (C) earned but unused vacation time. In addition, each change in control agreement provides that in the event that the severance and other benefits provided for in the agreement or otherwise payable to the executive would be subject to the excise tax imposed by Section 4999 of the Internal Revenue Code, the benefits under the agreement will be either delivered in full, or delivered to a lesser extent which would result in no portion of the benefits being subject to such excise tax, whichever is more beneficial to the executive.

ITEM 6. EXHIBITS

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

 

  10.1  Agreement and PlanForm of Merger among Meridian Bioscience, Inc. and Mariner Merger Sub, Inc. and Magellan Biosciences, Inc. and Ampersand 2006 Limited Partnership as the Stockholder RepresentativeChange in Control Agreement dated as of March 24,August 4, 2016 (filed herewith)
  10.2  Term Note with Fifth Third BankLetter Agreement dated March 22,July 26, 2016
  10.3Amended between the Company and Restated Revolving Note with Fifth Third dated March 22, 2016
  10.4Sixth Amendment to Loan and Security Agreement among Meridian Bioscience, Inc., Meridian Bioscience Corporation, Omega Technologies, Inc., Meridian Life Science, Inc., Bioline USA, Inc. and Fifth Third Bank dated March 22, 2016
  10.5Executive Employment Agreement between Meridian and Amy Winslow dated March 21, 2016Richard L. Eberly (filed herewith)
  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
101  The following financial information from Meridian Bioscience Inc.’s Quarterly Report on Form 10-Q for the quarter ended March 31,June 30, 2016 filed with the SEC on May 6,August 9, 2016, formatted in XBRL includes: (i) Condensed Consolidated Statements of Operations for the three and sixnine months ended March 31,June 30, 2016 and 2015; (ii) Condensed Consolidated Statements of Comprehensive Income for the three and sixnine months ended March 31,June 30, 2016 and 2015; (iii) Condensed Consolidated Statements of Cash Flows for the sixnine months ended March 31,June 30, 2016 and 2015; (iv) Condensed Consolidated Balance Sheets as of March 31,June 30, 2016 and September 30, 2015; (v) Condensed Consolidated Statement of Shareholders’ Equity for the sixnine months ended March 31,June 30, 2016; and (vi) the Notes to Condensed Consolidated Financial Statements

 

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SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

 

  MERIDIAN BIOSCIENCE, INC.
Date: May 6,August 9, 2016 By:   

/s/ Melissa A. Lueke

  Melissa A. Lueke
  

Executive Vice President and Chief Financial Officer

(Principal Financial and Accounting Officer)

 

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