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 June 30,December 31, 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).    Yesx  ☒    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 JulyJanuary 31, 20162017

Common Stock, no par value 42,086,73742,202,397


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 Nine Months Ended June 30,December 31, 2016 and 2015

   1  
  

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

   2  
  

Condensed Consolidated Statements of Cash Flows NineThree Months Ended June 30,December 31, 2016 and 2015

   3  
  

Condensed Consolidated Balance Sheets June 30,December 31, 2016 and September 30, 20152016

   4-5  
  

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

   6  
  

Notes to Condensed Consolidated Financial Statements

   7-137-12  
Item 2.  Management’s Discussion and Analysis of Financial Condition and Results of Operations   14-2113-19  
Item 3.  Quantitative and Qualitative Disclosures About Market Risk   2120  
Item 4.  Controls and Procedures   2120  
PART II.  OTHER INFORMATION  
Item 1A.  Risk Factors   22
Item 5.Other Information2220  
Item 6.  Exhibits   2220  
Signature     2321  

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.basis or in protecting its intellectual property. Meridian relies on proprietary, patented and licensed technologies, andtechnologies. As such, 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.products, as well as the uncertainty of regulatory approvals and the regulatory process. 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 Annual Report on Form 10-K contains a list and description of uncertainties, risks and other matters that may affect the Company. Readers should carefully review these forward-looking statements and risk factors and not place undue reliance on our forward-looking statements.


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
June 30,
 Nine Months Ended
June 30,
   Three Months Ended
December 31,
 
 2016 2015 2016 2015   2016 2015 

NET REVENUES

 $50,665   $48,204   $149,084   $147,762    $46,809  $47,160 

COST OF SALES

 17,756   17,873   51,020   55,673     17,359  15,577 
 

 

  

 

  

 

  

 

   

 

  

 

 

GROSS PROFIT

 32,909   30,331   98,064   92,089     29,450  31,583 
 

 

  

 

  

 

  

 

   

 

  

 

 

OPERATING EXPENSES

       

Research and development

 3,546   3,214   10,056   9,685     3,405  3,381 

Selling and marketing

 8,085   6,184   21,738   18,745     7,514  6,443 

General and administrative

 7,537   6,535   22,306   20,860     8,446  8,173 

Acquisition-related costs

  —      —     1,481    —    
 

 

  

 

  

 

  

 

   

 

  

 

 

Total operating expenses

 19,168   15,933   55,581   49,290     19,365  17,997 
 

 

  

 

  

 

  

 

   

 

  

 

 

OPERATING INCOME

 13,741   14,398   42,483   42,799     10,085  13,586 

OTHER INCOME (EXPENSE)

       

Interest income

 22   6   42   18     22  17 

Interest expense

 (427  —     (470  —       (423  —   

Other, net

 65   (99 (163 (892   (25 96 
 

 

  

 

  

 

  

 

   

 

  

 

 

Total other income (expense)

 (340 (93 (591 (874   (426 113 
 

 

  

 

  

 

  

 

   

 

  

 

 

EARNINGS BEFORE INCOME TAXES

 13,401   14,305   41,892   41,925     9,659  13,699 

INCOME TAX PROVISION

 4,647   5,203   15,154   14,852     3,380  4,806 
 

 

  

 

  

 

  

 

   

 

  

 

 

NET EARNINGS

 $8,754   $9,102   $26,738   $27,073    $6,279  $8,893 
 

 

  

 

  

 

  

 

   

 

  

 

 

BASIC EARNINGS PER COMMON SHARE

 $0.21   $0.22   $0.64   $0.65    $0.15  $0.21 

DILUTED EARNINGS PER COMMON SHARE

 $0.21   $0.22   $0.63   $0.64    $0.15  $0.21 

WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING - BASIC

 42,076   41,714   42,000   41,647     42,159  41,947 

EFFECT OF DILUTIVE STOCK OPTIONS AND RESTRICTED SHARES AND UNITS

 387   379   379   352  

EFFECT OF DILUTIVE STOCK OPTIONS AND RESTRICTED SHARE UNITS

   376  380 
 

 

  

 

  

 

  

 

   

 

  

 

 

WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING - DILUTED

 42,463   42,093   42,379   41,999     42,535  42,327 
 

 

  

 

  

 

  

 

   

 

  

 

 

ANTI-DILUTIVE SECURITIES:

       

Common share options and restricted shares and units

 465   493   449   567  

Common share options and restricted share units

   715  450 
 

 

  

 

  

 

  

 

   

 

  

 

 

DIVIDENDS DECLARED PER COMMON SHARE

 $0.20   $0.20   $0.60   $0.60    $0.20  $0.20 
 

 

  

 

  

 

  

 

   

 

  

 

 

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
June 30,
   Nine Months Ended
June 30,
   Three Months Ended
December 31,
 
  2016 2015   2016 2015   2016 2015 

NET EARNINGS

  $8,754   $9,102    $26,738   $27,073    $6,279  $8,893 

Other comprehensive income (loss):

         

Foreign currency translation adjustment

   (1,563 1,357     (2,479 (2,146   (1,423 (787

Unrealized loss on cash flow hedge

   (417  —       (1,111  —    

Unrealized gain on cash flow hedge

   1,560   —   

Income taxes related to items of other comprehensive income

   228    —       522    —       (589  —   
  

 

  

 

   

 

  

 

   

 

  

 

 

Other comprehensive income (loss), net of tax

   (1,752 1,357     (3,068 (2,146   (452 (787
  

 

  

 

   

 

  

 

   

 

  

 

 

COMPREHENSIVE INCOME

  $7,002   $10,459    $23,670   $24,927    $5,827  $8,106 
  

 

  

 

   

 

  

 

   

 

  

 

 

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)

 

Nine Months Ended June 30,

  2016 2015 

Three Months Ended December 31,

  2016 2015 

CASH FLOWS FROM OPERATING ACTIVITIES

      

Net earnings

  $26,738   $27,073    $6,279  $8,893 

Non-cash items included in net earnings:

      

Depreciation of property, plant and equipment

   2,871   2,585     1,078  896 

Amortization of intangible assets

   1,834   1,309     968  388 

Amortization of deferred instrument costs

   829   1,088     257  281 

Stock-based compensation

   2,654   2,676     1,884  1,611 

Deferred income taxes

   (753 (270   2,091  433 

Losses on long-lived assets

   659   39  

Change in current assets, net of acquisition

   (9,556 (4,399

Change in current liabilities, net of acquisition

   868   796  

Change in current assets

   1,616  (1,186

Change in current liabilities

   (869 834 

Other, net

   (140 299     (311 (58
  

 

  

 

   

 

  

 

 

Net cash provided by operating activities

   26,004   31,196     12,993  12,092 
  

 

  

 

   

 

  

 

 

CASH FLOWS FROM INVESTING ACTIVITIES

      

Purchase of property, plant and equipment

   (2,688 (3,783   (1,392 (776

Purchase of equity method investment

   (600  —       —    (600

Proceeds from sale of assets

   —     1,138  

Acquisition of Magellan, net of cash acquired

   (62,090  —    

Purchase of intangibles and other assets

   —    (16
  

 

  

 

   

 

  

 

 

Net cash used for investing activities

   (65,378 (2,645   (1,392 (1,392
  

 

  

 

   

 

  

 

 

CASH FLOWS FROM FINANCING ACTIVITIES

      

Dividends paid

   (25,233 (25,014   (8,440 (8,407

Proceeds from term loan, net of issuance costs

   59,851    —    

Payment on term loan

   (750  —       (750  —   

Proceeds and tax benefits from exercises of stock options

   2,033   654     301  1,470 
  

 

  

 

   

 

  

 

 

Net cash provided by (used for) financing activities

   35,901   (24,360

Net cash used for financing activities

   (8,889 (6,937
  

 

  

 

   

 

  

 

 

Effect of Exchange Rate Changes on Cash and Equivalents

   (697 (1,263   (662 (314
  

 

  

 

   

 

  

 

 

Net (Decrease) Increase in Cash and Equivalents

   (4,170 2,928  

Net Increase in Cash and Equivalents

   2,050  3,449 

Cash and Equivalents at Beginning of Period

   49,973   43,047     47,226  49,973 
  

 

  

 

   

 

  

 

 

Cash and Equivalents at End of Period

  $45,803   $45,975    $49,276  $53,422 
  

 

  

 

   

 

  

 

 

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

 

  June 30,
2016

(Unaudited)
   September 30,
2015
   December 31,
2016
(Unaudited)
   September 30,
2016
 

CURRENT ASSETS

        

Cash and equivalents

  $45,803    $49,973    $49,276   $47,226 

Accounts receivable, less allowances of $341 and $248

   31,312     26,254  

Accounts receivable, less allowances of $346 and $334

   24,278    27,102 

Inventories

   43,409     35,817     44,709    45,057 

Prepaid expenses and other current assets

   6,396     7,378     7,785    7,406 
  

 

   

 

   

 

   

 

 

Total current assets

   126,920     119,422     126,048    126,791 
  

 

   

 

   

 

   

 

 

PROPERTY, PLANT AND EQUIPMENT, at Cost

        

Land

   984     986     1,147    1,155 

Buildings and improvements

   32,042     30,056     31,595    31,487 

Machinery, equipment and furniture

   45,893     41,541     45,712    45,085 

Construction in progress

   1,824     1,139     1,953    1,947 
  

 

   

 

   

 

   

 

 

Subtotal

   80,743     73,722     80,407    79,674 

Less: accumulated depreciation and amortization

   50,670     46,230     49,975    49,224 
  

 

   

 

   

 

   

 

 

Net property, plant and equipment

   30,073     27,492     30,432    30,450 
  

 

��  

 

   

 

   

 

 

OTHER ASSETS

        

Goodwill

   63,698     22,349     60,705    61,982 

Other intangible assets, net

   31,384     5,931     29,348    29,855 

Restricted cash

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

Deferred instrument costs, net

   1,503     1,750     1,339    1,392 

Deferred income taxes

   —       4,954  

Fair value of interest rate swap

   831    —   

Other assets

   368     384     352    353 
  

 

   

 

   

 

   

 

 

Total other assets

   97,953     36,368     93,575    94,582 
  

 

   

 

   

 

   

 

 

TOTAL ASSETS

  $254,946    $183,282    $250,055   $251,823 
  

 

   

 

   

 

   

 

 

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

 

  June 30,
2016

(Unaudited)
 September 30,
2015
   December 31,
2016
(Unaudited)
 September 30,
2016
 

CURRENT LIABILITIES

      

Accounts payable

  $7,386   $6,646    $7,511  $7,627 

Accrued employee compensation costs

   5,425   5,132     5,064  7,106 

Other accrued expenses

   2,558   2,587     2,833  2,606 

Current portion of long-term debt

   3,375    —       4,125  3,750 

Income taxes payable

   1,504   886     1,511  1,482 
  

 

  

 

   

 

  

 

 

Total current liabilities

   20,248   15,251     21,044  22,571 
  

 

  

 

   

 

  

 

 

NON-CURRENT LIABILITIES

      

Acquisition consideration

   2,198    —       2,383  2,383 

Non-current compensation liabilities

   2,252   2,158     2,458  2,305 

Interest rate swap liability

   1,111    —    

Fair value of interest rate swap

   —    729 

Long-term debt

   55,726    —       53,495  54,610 

Deferred income taxes

   4,558    —       4,943  2,753 
  

 

  

 

   

 

  

 

 

Total non-current liabilities

   65,845   2,158     63,279  62,780 
  

 

  

 

   

 

  

 

 

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, 42,078,657 and 41,838,399 shares issued, respectively

   —      —    

Common shares, no par value; 71,000,000 shares authorized, 42,202,067 and 42,106,587 shares issued, respectively

   —     —   

Additional paid-in capital

   121,694   117,151     124,229  122,356 

Retained earnings

   52,557   51,052     47,471  49,632 

Accumulated other comprehensive loss

   (5,398 (2,330   (5,968 (5,516
  

 

  

 

   

 

  

 

 

Total shareholders’ equity

   168,853   165,873     165,732  166,472 
  

 

  

 

   

 

  

 

 

TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY

  $254,946   $183,282    $250,055  $251,823 
  

 

  

 

   

 

  

 

 

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  

Balance at September 30, 2016

   42,107   $122,356  $49,632  $(5,516 $166,472 

Cash dividends paid

   —       —       (25,233  —     (25,233   —      —    (8,440  —    (8,440

Exercise of stock options

   125     1,889     —      —     1,889     18    (11  —     —    (11

Conversion of restricted stock units

   116     —       —      —      —    

Conversion of restricted share units

   77    —     —     —     —   

Stock compensation expense

   —       2,654     —      —     2,654     —      1,884   —     —    1,884 

Net earnings

   —       —       26,738    —     26,738     —      —    6,279   —    6,279 

Foreign currency translation adjustment

   —       —       —     (2,375 (2,375   —      —     —    (1,423 (1,423

Hedging activity, net of tax

   —       —       —     (693 (693   —      —     —    971  971 
  

 

   

 

   

 

  

 

  

 

   

 

   

 

  

 

  

 

  

 

 

Balance at June 30, 2016

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

Balance at December 31, 2016

   42,202   $124,229  $47,471  $(5,968 $165,732 
  

 

   

 

   

 

  

 

  

 

   

 

   

 

  

 

  

 

  

 

 

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 June 30,December 31, 2016, the results of its operations for the three and nine month periods ended June 30,December 31, 2016 and 2015, and its cash flows for the ninethree month periods ended June 30,December 31, 2016 and 2015. These statements should be read in conjunction with the consolidated financial statements and footnotes thereto included in the Company’s fiscal 20152016 Annual Report on Form 10-K. Financial information as of September 30, 20152016 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 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. The Company’s Condensed Consolidated Statements of Operations for both the three and nine months ended June 30, 2016 include Magellan’s results of operations since the March 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 20152016 Annual Report on Form 10-K.

Recent Accounting Pronouncements –

(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). TheWhile the Company has begun the process of identifying, categorizing and analyzing its various revenue streams, 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.

Page 7


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.

In August 2016, the FASB issued ASU 2016-15,Classification of Certain Cash Receipts and Cash Payments. The update addresses certain specific cash flows and their treatment, with the objective being to reduce the existing diversity in how the items are presented and classified within the statement of cash flows. Adoption and implementation of the guidance is not required by the Company until the beginning of fiscal 2019, although early adoption is permitted. Adoption of this guidance is not expected to have a significant impact on the Company’s statement of cash flows.

Page 7


In October 2016, the FASB issued ASU 2016-16,Intra-Entity Transfers of Assets Other Than Inventory, which intends to improve the accounting for the income tax consequences of intra-entity transfers of assets other than inventory. Adoption and implementation of the guidance is not required by the Company until the beginning of fiscal 2019, although early adoption is permitted. While the Company has not yet completed its assessment of the impact that adoption of this guidance will have on its financial statements, in light of the levels of such transfer activity within the Company, adoption of this guidance is not expected to have a significant impact on the Company’s consolidated results of operations, cash flows or financial position.

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 $67,690,$67,874, 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$2,383 remains payable to the sellers, pending the realization of tax benefits for certain net operating loss carryforwards in future tax returns.returns, which is included within non-current liabilities on our Condensed Consolidated Balance Sheet. 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 ofSince the consideration paid exceedingexceeds the preliminary fair value of the net assets acquired, goodwill in the amount of $42,740$40,572 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 nine months ended June 30, 2016 include $1,173 of acquisition-related costs related to the

The Magellan acquisition, which are reflected as Operating Expenses.

In addition to Magellan’s results of operations, which are included in our Condensed Consolidated StatementsStatement of Operations for the three and nine months ended June 30,December 31, 2016 and reported as part of the Diagnostics operating segment, include $726 of general and administrative expenses 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.

The Company’s consolidated results for the three and nine months ended June 30,December 31, 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 ofinclude net revenues and net earnings from Magellan included in the consolidated results of the Company for the threetotaling $5,199 and nine months ended June 30, 2016 are as follows, reflecting$468, respectively, and reflect the items noted above but excludingand exclude interest expense on the debt secured by Meridian in connection with the transaction:transaction.

 

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

Net Revenues

  $4,752    $4,752  

Net Earnings

  $231    $231  

Page 8


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)
   March 24,
2016

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

(as adjusted)
 

Fair value of assets acquired -

            

Cash and equivalents

  $3,420    $(20  $3,400    $3,400   $—     $3,400 

Accounts receivable

   1,700     —       1,700     1,700    —      1,700 

Inventories

   1,400     —       1,400     1,400    —      1,400 

Other current assets

   330     10     340     300    —      300 

Property, plant and equipment

   2,790     (200   2,590     2,800    (200   2,600 

Goodwill

   42,730     10     42,740     42,800    (2,200   40,600 

Other intangible assets (estimated useful life):

            

Customer relationships (15 years)

   12,630     —       12,630     12,600    300    12,900 

Technology (10 years)

   10,550     —       10,550     10,600    300    10,900 

Non-compete agreements (2 years)

   740     —       740     700    —      700 

Trade names (approximate 5 year weighted average)

   3,690     —       3,690  

Trade names (approximate 9 year weighted average)

   3,700    (700   3,000 
  

 

   

 

   

 

   

 

   

 

   

 

 
   79,980     (200   79,780     80,000    (2,500   77,500 

Fair value of liabilities assumed -

            

Accounts payable and accrued expenses

   1,610     (20   1,590     1,600    100    1,700 

Deferred income tax liabilities

   10,570     (70   10,500     10,600    (2,700   7,900 
  

 

   

 

   

 

   

 

   

 

   

 

 

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

  $67,800    $(110  $67,690  

Total consideration (including $2,400 accrued to be paid; see discussion above)

  $67,800   $100   $67,900 
  

 

   

 

   

 

   

 

   

 

   

 

 

As indicated, the allocation of the purchase price and estimated useful lives of property, plant and equipment, and intangible assets shown remain 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, 2014,2015, are as follows for the periods indicated:

 

  

Three Months Ended

June 30,

   

Nine Months Ended

June 30,

   Three Months Ended
December 31,
 
  2016   2015   2016   2015   2016   2015 

Net Revenues

  $50,665    $52,255    $156,722    $159,225    $46,809   $51,095 

Net Earnings

  $8,776    $8,698    $26,194    $25,446    $6,279   $8,517 

Diluted Earnings Per Common Share

  $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 give effect to the following, as if the acquisition had been consummated on October 1, 2014,2015, together with the consequential tax effects thereon:

 

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

(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)869 in the quarter ended December 31, 2015);

 

 (iii)(ii)reflect equity-based awards granted under the Company’s 2012 Stock Incentive Plan to certain Magellan employees in accordance with executed employeeemployment agreements, and to certain Meridian employees to reward them for their efforts in connection with the transaction;transaction ($110 in the quarter ended December 31, 2015); and

 

 (iv)(iii)reflect the interest expense that would have been incurred on the Company’s $60,000 term note.note ($429 in the quarter ended December 31, 2015).

 

Page 9


4.Cash and Equivalents

Cash and equivalents include the following components:

 

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

Overnight repurchase agreements

  $7,877    $—      $25,436    $—    

Institutional money market funds

   10,010     —       —       —    

Cash on hand -

        

Restricted

   —       1,000     —       1,000  

Unrestricted

   27,916     —       24,537     —    
  

 

 

   

 

 

   

 

 

   

 

 

 

Total

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

 

 

   

 

 

   

 

 

   

 

 

 

   December 31, 2016   September 30, 2016 
   Cash and
Equivalents
   Other
Assets
   Cash and
Equivalents
   Other
Assets
 

Overnight repurchase agreements

  $15,628   $—     $9,988   $—   

Institutional money market funds

   10,006    —      10,020    —   

Cash on hand -

        

Restricted

   —      1,000    —      1,000 

Unrestricted

   23,642    —      27,218    —   
  

 

 

   

 

 

   

 

 

   

 

 

 

Total

  $49,276   $1,000   $47,226   $1,000 
  

 

 

   

 

 

   

 

 

   

 

 

 

 

Page 10


5.Inventories

Inventories are comprised of the following:

 

  June 30,
2016
   September 30,
2015
   December 31,
2016
   September 30,
2016
 

Raw materials

  $7,810    $7,095    $7,642   $7,639 

Work-in-process

   12,432     10,096     13,535    13,146 

Finished goods - instruments

   2,384     1,890     2,113    2,378 

Finished goods - kits and reagents

   20,783     16,736     21,419    21,894 
  

 

   

 

   

 

   

 

 

Total

  $43,409    $35,817    $44,709   $45,057 
  

 

   

 

   

 

   

 

 

 

6.Intangible Assets

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

 

  June 30, 2016   September 30, 2015   December 31, 2016   September 30, 2016 
  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

  $21,962    $11,270    $11,582    $10,906    $22,230   $11,800   $21,921   $11,540 

Tradenames, licenses and patents

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

Customer lists and relationships, and supply agreements

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

Trade names, licenses and patents

   9,035    4,124    9,037    3,947 

Customer lists, customer relationships and supply agreements

   24,285    10,728    24,385    10,511 

Non-compete agreements

   740     93     —       —       720    270    680    170 
  

 

   

 

   

 

   

 

   

 

   

 

   

 

   

 

 
  $56,837    $25,453    $30,097    $24,166    $56,270   $26,922   $56,023   $26,168 
  

 

   

 

   

 

   

 

   

 

   

 

   

 

   

 

 

Page 10


The actual aggregate amortization expense for these intangible assets was $1,072$968 and $409$388 for the three months ended June 30, 2016 and 2015, respectively, and $1,834 and $1,309 for the nine months ended June 30,December 31, 2016 and 2015, respectively. The estimated aggregate amortization expense for these intangible assets for each of the fiscal years through fiscal 20212022 is as follows: remainder of fiscal 2016 – $987, fiscal 2017 – $4,041,$2,794, fiscal 2018 – $3,835,$3,524, fiscal 2019 – $3,609,$3,303, fiscal 2020 – $3,445, and$3,144, fiscal 2021 – $2,576.$2,560, and fiscal 2022 – $2,164.

 

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 due March 31, 2021. The required principal payments on the term loan for each of $37,500 at the endfive succeeding fiscal years are as follows: remainder of five years. Due to the recent execution datefiscal 2017 – $3,000, fiscal 2018 – $4,500, fiscal 2019 – $5,250, fiscal 2020 – $6,000, and fiscal 2021 – $39,000. In light of the term loan andloan’s interest being determined on a variable rate basis, the fair value of the term loan at June 30,December 31, 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 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. As 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.rate of 2.76%. 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 rate 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 June 30,December 31, 2016, the fair value of the interest rate swap was a liabilityan asset of $1,111,$831, and is reflected as a non-current liabilityasset in the accompanying Condensed Consolidated Balance Sheet. This fair value was determined by reference to a third party valuation, and is considered a Level 2 input within the fair value hierarchy of valuation techniques.

In addition, the Company continues to maintain a $30,000 revolving credit facility with a commercial bank, which expires March 31, 2021. There were no borrowings outstanding on this credit facility at December 31, 2016 or September 30, 2016.

The term loan and the revolving 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. As of December 31, 2016, the Company is in compliance with all covenants. The Company is also required to maintain a cash compensating balance with the bank in the amount of $1,000, and is in compliance with this requirement.

 

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.

Our reportable segments are Diagnostics and Life Science, both of which are headquartered in Cincinnati, Ohio, which also serves as theScience. The Diagnostics segment’s basesegment consists of manufacturing operations and research and development for infectious disease products. The Diagnostics segment includes the Company’s recent acquisition of Magellan, which is locatedproducts in Cincinnati, Ohio; Magellan’s manufacturing operations for products detecting elevated lead levels in blood in Billerica, Massachusetts (near Boston). Its facility includes research, development, manufacturing, marketing, sales,; and the sale and distribution operations. The Diagnostics segment has salesof diagnostics products domestically and distribution facilities forabroad. This segment’s products are used by hospitals, reference labs and physician offices to detect infectious disease diagnostics in the United States, Europediseases and Australia. elevated lead levels.

Page 11


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. This segment’s products are used by manufacturers and researchers in a variety of applications (e.g., in-vitro medical device manufacturing, microRNA detection, next-gen sequencing, and plant genotyping and mutation detection, among others).

Amounts due from two Diagnostics distributor customers accounted for 23%12% and 21%16% of consolidated accounts receivable at June 30,December 31, 2016 and September 30, 2015,2016, respectively. Revenues from these two distributor customers accounted for 25%23% and 35%39% of the Diagnostics segment third-party revenues during the three months ended June 30,December 31, 2016 and 2015, respectively, and 30%represented 17% and 36% during the nine months ended June 30, 2016 and 2015, respectively. These distributors represented 19% and 26%29% of consolidated revenues for the fiscal 2017 and 2016 and 2015 thirdfirst quarters, respectively, and 22% and 27% for the respective year-to-date nine month periods.respectively.

Within our Life Science segment, two diagnostic manufacturing customers accounted for 23%19% and 16%18% of the segment’s third-party revenues during the three months ended June 30, 2016 and 2015, respectively, and 20% and 16% during the nine months ended June 30,December 31, 2016 and 2015, respectively.

Page 12


Segment information for the interim periods is as follows:

 

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

Three Months Ended June 30, 2016

        

Three Months Ended December 31, 2016

Three Months Ended December 31, 2016

  

Net revenues -

                

Third-party

  $37,523    $13,142    $—      $50,665    $33,808   $13,001   $—     $46,809 

Inter-segment

   70     201     (271   —       79    125    (204   —   

Operating income

   9,886     3,696     159     13,741     6,643    3,267    175    10,085 

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

        

Goodwill (December 31, 2016)

   41,823    18,882    —      60,705 

Other intangible assets, net (December 31, 2016)

   27,292    2,056    —      29,348 

Total assets (December 31, 2016)

   184,592    65,525    (62   250,055 

Three Months Ended December 31, 2015

        

Net revenues -

                

Third-party

  $36,049    $12,155    $—      $48,204    $35,301   $11,859   $—     $47,160 

Inter-segment

   46     345     (391   —       71    367    (438   —   

Operating income

   11,383     3,060     (45   14,398     10,330    3,236    20    13,586 

Goodwill (September 30, 2015)

   1,250     21,099     —       22,349  

Other intangible assets, net (September 30, 2015)

   2,364     3,567     —       5,931  

Total assets (September 30, 2015)

   119,939     63,670     (327   183,282  

Nine Months Ended June 30, 2016

        

Net revenues -

        

Third-party

  $110,178    $38,906    $—      $149,084  

Inter-segment

   225     955     (1,180   —    

Operating income

   31,412     11,086     (15   42,483  

Nine Months Ended June 30, 2015

        

Net revenues -

        

Third-party

  $111,297    $36,465    $—      $147,762  

Inter-segment

   235     867     (1,102   —    

Operating income

   33,750     9,145     (96   42,799  

Goodwill (September 30, 2016)

   42,608    19,374    —      61,982 

Other intangible assets, net (September 30, 2016)

   27,534    2,321    —      29,855 

Total assets (September 30, 2016)

   185,241    66,624    (42   251,823 

 

(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 1312


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 HighlightsOverview

As more fully detailed below,The first quarter of fiscal 2017 was characterized by strong performance from our Life Science and Magellan business units, with significant weakness in our core diagnostics business in the thirdU.S. (part of our Americas region). Our core diagnostics business in the EMEA region (as defined within the Reportable Segment section below) grew by 5% over the first quarter of fiscal 2016 was highlighted by it beingon a constant-currency basis. While we have implemented measures to stabilize our Americas core diagnostics business, including making changes to our senior management team and strengthening our relationships with key distribution partners, the recovery in our core diagnostics unit is proceeding more slowly than planned. As a result, first quarter earnings were depressed, as the core diagnostics unit generates the largest contribution to our profits.

In addition to implementing the measures noted above, we are in the process of taking further action to align resources, reduce expenses and optimize investments in product development. The results of the first fiscal quarter have led to include the results of operations of Magellan Biosciences, Inc.,downward revision to our fiscal 2017 revenue 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 forearnings guidance, and the testing of blood to diagnose lead poisoning in children and adults. Magellan is the leading provider of point-of-care lead testing systemsannual indicated dividend rate has been reduced (as more fully discussed in the U.S. In addition, duringLiquidity and Capital Resources section below), better aligning with our stated dividend payout range and enabling the quarter we commercialized ourillumigene® Mycoplasma DirectCompany to fund global expansion and new product in the U.S., representing the tenth assay for ourillumigene molecular platform menu.development.

Three Months Ended June 30,December 31, 2016

Net earnings for the thirdfirst quarter of fiscal 20162017 decreased 4%29% to $8,754,$6,279, or $0.21$0.15 per diluted share, from net earnings for the thirdfirst quarter of fiscal 20152016 of $9,102,$8,893, or $0.22$0.21 per diluted share. Consolidated revenues increased 5%decreased 1% to $50,665$46,809 for the thirdfirst quarter of fiscal 20162017 compared to the same period of the prior year (also up 5%(flat on a constant-currency basis).

Revenues for the Diagnostics segment for the thirdfirst quarter of fiscal 2017 decreased 4% compared to the first quarter of fiscal 2016 increased 4% compared to the third quarter of fiscal 2015 (also updown 4% on a constant-currency basis), composedcomprised of a 5%22% decrease in molecular products and an 8%a 2% increase in non-molecular products, reflecting $4,800including $5,199 of Magellan revenues. With 15% growthan 11% increase in its immunoassay components business and a 1% declinean 8% increase in its molecular components business, revenues of our Life Science segment increased by 8%10% during the thirdfirst quarter of fiscal 2017 compared to the first quarter of fiscal 2016, compared to the third quarter of fiscal 2015, increasing 9% on a constant-currency basis.

Nine Months Ended June 30, 2016

For the nine month period ended June 30, 2016, net earnings decreased 1% to $26,738, or $0.63 per diluted share, compared to net earnings for the comparable fiscal 2015 period of $27,073, or $0.64 per diluted share. Reflected within the year-to-date fiscal 2016 results are 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 increased 1% to $149,084 for the first nine months of fiscal 2016 compared to the same period of the prior year, increasing 2% on a constant-currency basis.

During the first nine months of fiscal 2016, revenues for the Diagnostics segment decreased 1% from the comparable fiscal 2015 period (flat on a constant-currency basis), composed of a 4% decrease in molecular products and flat non-molecular products revenue, reflecting $4,800 of Magellan revenues. With 12% growth in its immunoassay components business and a 1% decline in its molecular components business, revenues of our Life Science segment increased by 7% during the first nine months of fiscal 2016, increasing 8% on a constant-currency basis.

 

Page 1413


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

Revenue Overview – By Reportable Segment & Geographic Region

Our reportable segments are Diagnostics and Life Science. The Diagnostics segment consists of manufacturing operations for infectious diseaseScience, with products in Cincinnati, Ohio and as a result of the acquisition of Magellan, manufacturing operations for products detecting elevated lead levels in blood in Billerica, Massachusetts (near Boston). These diagnostic test products are sold and distributed in the countries comprising North Central and SouthLatin 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 consistsA full description of manufacturing operationsour segments is set forth in Memphis, Tennessee; Boca Raton, Florida; London, England; Luckenwalde, Germany; and Sydney, Australia, andNote 8 of 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.accompanying Condensed Consolidated Financial Statements.

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

Diagnostics -

           

Americas

  $31,885   $30,410   5 $93,864   $93,502   —    $27,569  $30,115  (8)% 

EMEA

   4,826   4,651   4 14,357   15,184   (5)%    5,662  4,649  22

ROW

   812   988   (18)%  1,957   2,611   (25)%    577  537  7
  

 

  

 

  

 

  

 

  

 

  

 

   

 

  

 

  

 

 

Total Diagnostics

   37,523   36,049   4 110,178   111,297   (1)%    33,808  35,301  (4)% 
  

 

  

 

  

 

  

 

  

 

  

 

   

 

  

 

  

 

 

Life Science -

           

Americas

   4,790   5,065   (5)%  16,249   16,274   —     5,399  5,103  6

EMEA

   5,977   4,877   23 15,127   13,637   11   4,898  4,536  8

ROW

   2,375   2,213   7 7,530   6,554   15   2,704  2,220  22
  

 

  

 

  

 

  

 

  

 

  

 

   

 

  

 

  

 

 

Total Life Science

   13,142   12,155   8 38,906   36,465   7   13,001  11,859  10
  

 

  

 

  

 

  

 

  

 

  

 

   

 

  

 

  

 

 

Consolidated

  $50,665   $48,204   5 $149,084   $147,762   1  $46,809  $47,160  (1)% 
  

 

  

 

  

 

  

 

  

 

  

 

   

 

  

 

  

 

 

% of total revenues -

           

Diagnostics

   74 75  74 75    72 75 

Life Science

   26 25  26 25    28 25 
  

 

  

 

   

 

  

 

    

 

  

 

  

Total

   100 100  100 100    100 100 
  

 

  

 

   

 

  

 

    

 

  

 

  

Ex-Americas

   28 26  26 26    30 25 
  

 

  

 

   

 

  

 

    

 

  

 

  

 

Page 1514


Revenue 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)Non-molecular tests on multiple technology platforms (including our Magellan diagnostics blood lead test)

Life Science

 

 1)Molecular components

 

 2)Immunoassay components

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

 

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

Diagnostics -

           

Molecular

  $10,063   $10,550   (5)%  $29,564   $30,650   (4)%   $7,711  $9,836  (22)% 

Non-molecular

   27,460   25,499   8 80,614   80,647   —     26,097  25,465  2
  

 

  

 

  

 

  

 

  

 

  

 

   

 

  

 

  

 

 

Total Diagnostics

  $37,523   $36,049   4 $110,178   $111,297   (1)%   $33,808  $35,301  (4)% 
  

 

  

 

  

 

  

 

  

 

  

 

   

 

  

 

  

 

 

Life Science -

           

Molecular components

  $5,037   $5,104   (1)%  $14,902   $15,009   (1)%   $5,116  $4,749  8

Immunoassay components

   8,105   7,051   15 24,004   21,456   12   7,885  7,110  11
  

 

  

 

  

 

  

 

  

 

  

 

   

 

  

 

  

 

 

Total Life Science

  $13,142   $12,155   8 $38,906   $36,465   7  $13,001  $11,859  10
  

 

  

 

  

 

  

 

  

 

  

 

   

 

  

 

  

 

 

% of Diagnostics revenues -

           

Molecular

   27 29  27 28    23 28 

Non-molecular

   73 71  73 72    77 72 
  

 

  

 

   

 

  

 

    

 

  

 

  

Total Diagnostics

   100 100  100 100    100 100 
  

 

  

 

   

 

  

 

    

 

  

 

  

% of Life Science revenues -

           

Molecular components

   38 42  38 41    39 40 

Immunoassay components

   62 58  62 59    61 60 
  

 

  

 

   

 

  

 

    

 

  

 

  

Total Life Science

   100 100  100 100    100 100 
  

 

  

 

   

 

  

 

    

 

  

 

  

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

Diagnostics Products

Molecular Products

Revenues for ourillumigene molecular platform of products decreased 5%22% to $10,000$7,711 for the first quarter of fiscal 2016 third quarter2017 (also 5% in constant-currency), and decreased 4% to $29,600 for the nine month year-to-date period (3% in constant-currency)22% on a constant-currency basis). These decreases reflectThis decrease reflects the ongoing intenseincreased competition within the molecular-based testing market.market, most notably within the market forC. difficile testing.

We have nearly 1,600over 1,500 customer account placements, adding 25 customers and 35 assays since our last report.placements. Of these account placements, approximately 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 400450 accounts that are regularly purchasing, evaluating and/or validating two or more assays. Increasing the number of customers utilizing two or more assays is a focus, as this makes it more difficult for competitors to attack our customers.

 

Page 1615


We continue to invest in new product development for our molecular testing platform, 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

 

4.illumigene® Mycoplasma (M. pneumonia;pneumoniae;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 in July 2015

 

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

 

10.illumigene® Mycoplasma Direct (M. pneumonia;pneumoniae;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.care, and during the first quarter of fiscal 2017 we experienced 6% growth in all testing categories, other than the hyper-competitiveC. difficile arena. 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-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 tofor any size hospital or physician office laboratory that runs moderately-complex tests. We continue to invest in the development of additional assays for this platform.

Non-molecular Products

Revenues from our Diagnostics segment’s non-molecular products increased 8%2% in the thirdfirst quarter of fiscal 2016 and were flat on a nine month year-to-date basis.2017. These results reflect the addition of Magellan’s revenue, increasedlargely offset by decreased revenues in ourH. pylori immunoassay products and an overall decrease in revenues of our other immunoassay product lines.

SinceDuring the March 24, 2016 acquisition,first quarter of fiscal 2017, revenues from Magellan’s sales of products to test for elevated levels of lead in blood have totaled $4,800 – all of which, as previously noted, are reflected within Meridian’s results for the three and nine months ended June 30, 2016.$5,199. This level of revenues reflects a 17%32% increase over the three-month period ended June 30,December 31, 2015, which was prior to Meridian ownership.Meridian’s ownership of Magellan.

During the first quarter of fiscal 2016 third quarter,2017, revenues from ourH. pylori products increased 1%decreased 18% (also 1% in constant-currency)18% on a constant-currency basis) to $8,100. These revenues grew 9% to $25,100 during the first nine months of$7,156. In fiscal 2016, (10% in constant-currency). These increaseswe employed bulk-buy sales promotions (also referred to as “stock-and-block” programs) intended to increase major customer inventory levels as a defense against potential competitors upon the expiration of our patent, as further described below. Although certain participating customers are continuing to consume the inventory purchased as part of this program, we expect ourH. pylorirevenue to return to low single-digit growth for fiscal year 2017. This growth expectation reflects customers working through this inventory and replenishing product, and our realizing volume growth from the ongoing conversion of serology testing to our antigen tests. We continue to reflect thebelieve there are ongoing benefits ofto be realized from 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 of 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 additionWe recently introduced capabilities to our managed care strategy, we have also employed bulk-buy sales promotions into selected distributionidentify resistance to Clarithromycin, the antibiotic commonly used to treatH. pylori. We believe that partnering the ability to diagnoseH. pylori and laboratory channels asidentify resistance is a defensive strategy against potential newstrong competitive product introductions expected later in the year.advantage.

The patents for ourH. pylori products are owned by us and expired in May 2016 in the U.S., and will expire in fiscal 2017 in countries outside the U.S. We expect competition with respect to ourH. pylori products to increase in 2016 andfiscal 2017 as we currently market the only FDA-cleared testtests 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, among other things, we are researching and experimenting withcompetition, our product development pipeline includes multiple new products and attempting to secure significant customers under long-term contracts.product initiatives for the detection ofH. pylori. 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.

 

Page 1716


During the first quarter of fiscal 2016 third quarter,2017, revenues from our other immunoassay products (includingC. difficile, foodborne and respiratory) decreased 18% (also 18% in constant-currency)on a constant-currency basis) to $14,400. These revenues decreased 13% to $49,700 during the first nine months of fiscal 2016 (12% in constant-currency). These decreases result$13,615. This decrease results 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 thirdfirst quarter of fiscal 2016,2017, revenues from our Life Science segment increased 8%10%, with revenues from molecular component sales decreasing 1%increasing 8% from the comparable fiscal 20152016 quarter and revenues 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 fiscal 2015 period and revenues from immunoassay component sales increasing 12%11%. Our molecular component business’ growth was negatively impacted by the movement in currency exchange rates since the first quarter of fiscal 2015 periods,2016, with revenues increasing 2% and 3%15% on a constant-currency basis over the thirdfirst quarter and first nine months of fiscal 2015, respectively. The weaker growth compared to the last several years is primarily due to several large customers delaying orders in connection with their new product launches and recent customer merger activity.2016. Our Life Science segment continued to benefit from increased sales into China, with such sales totaling approximately $500 and $2,000$700 during the first quarter of fiscal 2016 third quarter2017 (approximately $200 in the molecular components business and year-to-date periods, respectively, primarily$500 in the immunoassay components business; representing an approximate 25% increase over the fiscal 2015 year-to-date period.business). New products also contributed to growth, including EPIK™ miRNA Select, JetSeq™, SensiFast™ Lyo-Ready and MIC Personal qPCR Cycler and accessories.

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.

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 ninethree months of fiscal 2016, and fiscal 2015, the Company recorded approximately $500 and $1,500, respectively, of medical device tax expense, ($0 and $500 in the third 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 June 30, Nine Months Ended June 30,   Three Months Ended December 31, 
  2016 2015 Change 2016 2015 Change   2016 2015 Change 

Gross Profit

  $32,909   $30,331   8 $98,064   $92,089   6  $29,450  $31,583  (7)% 

Gross Profit Margin

   65 63 +2 points   66 62 +4 points     63 67  -4 points  

The overall gross profit increasesdecreases experienced in fiscal 20162017 primarily result from the combined effects of (i) mix of products sold, particularly thedecreased contribution from our higher revenue contribution frommarginH. pylori products; (ii) realizationcustomer mix; and (iii) decreased production levels in certain 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. Product revenue mix shifts, in the normal course of business, can cause the consolidated gross profit margin to fluctuate by several points.production facilities.

 

Page 1817


Operating Expenses

 

   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

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

2015 Expenses

  $9,685   $18,745   $20,860   $—     $49,290  
  

 

  

 

  

 

  

 

  

 

 

% of Revenues

   7 13 14 —   33

Fiscal 2016 Increases (Decreases):

  

Diagnostics

   667   2,033   1,476   1,481   5,657  

Life Science

   (296 960   (30  —     634  
  

 

  

 

  

 

  

 

  

 

   Research &
Development
 Selling &
Marketing
 General &
Administrative
 Total Operating
Expenses
 

2016 Expenses

  $10,056   $21,738   $22,306   $1,481   $55,581    $3,381  $6,443  $8,173  $17,997 
  

 

  

 

  

 

  

 

  

 

   

 

  

 

  

 

  

 

 

% of Revenues

   7 15 15 1 37   7 14 17 38

Fiscal 2017 Increases (Decreases):

     

Diagnostics

   60  942  506  1,508 

Life Science

   (36 129  (233 (140
  

 

  

 

  

 

  

 

 

2017 Expenses

  $3,405  $7,514  $8,446  $19,365 
  

 

  

 

  

 

  

 

 

% of Revenues

   7 16 18 41

% Increase

   4 16 7 NMF   13   1 17 3 8

Total operating expenses increased during both the thirdfirst quarter of fiscal 2016 and the first nine months of fiscal 20162017 compared to the correspondingfirst quarter of fiscal 2015 periods. These levels2016. This level of operating expenses resultresults primarily from the combined effects of (i) the following:

Diagnostics

Quarterly

Additionaddition of Magellan’s operating expenses which represent approximately 75% of the total Diagnosticstotaling $2,800; and (ii) decreased operating expense increase; and

Increased investmentexpenses in Sales & Marketing activities,our core diagnostics business, including the additioneffect of new sales territories.

Year-to-Daterevising vacation accrual policies.

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

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

Page 19


Life Science

Quarterly & Year-to-Date

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

Operating Income

Operating income decreased 5%26% to $13,741$10,085 for the thirdfirst quarter of fiscal 2016, and decreased 1% to $42,483 for the first nine months of fiscal 2016,2017, as a result of the factors discussed above.

Income Taxes

The effective rate for income taxes was 35% and 36% for both the third quartersfirst quarter of fiscal 20162017 and 2015, respectively, and 36% and 35%, respectively, for the nine-month year-to-date periods ended June 30, 2016 and 2015, respectively. The year-to-date increase primarily results from the non-deductibility of certain expenses incurred in connection with the Company’s acquisition activities.2016. For the fiscal year ending September 30, 2016,2017, we expect the effective tax rate to approximate 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, debt service, 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.

Upon considering fiscal 2017 first quarter results and business trends, the Board of Directors has taken steps to bring the annual dividend rate more in line with our long-standing policy of establishing a cash dividend payout ratio of between 75% and 85% of diluted earnings per share. On January 25, 2017 it was announced that the fiscal 2017 indicated cash dividend rate had been reduced to $0.50 per share (down from $0.80 per share, and representing approximately 75% of the revised fiscal 2017 earnings per diluted share guidance), and a first quarter cash dividend of $0.125 per share was declared (down from $0.20 per share, and representing 83% of first quarter earnings per diluted share). This reduction in the annual indicated dividend rate is intended to enable the Company to fund its ongoing global expansion and new product development efforts.

We have an investment policy that guides the holdings of our investment portfolio, which presently consists of overnight repurchase agreements, bank savings accounts and institutional money market mutual funds (beginningfunds. Our objectives in April). Our objectivesmanaging the investment portfolio are to (i) preserve capital; (ii) provide sufficient liquidity to meet working capital requirements and fund strategic objectives such as acquisitions; and (iii) capture a market rate of return commensurate with market conditions and our policy’s investment eligibility criteria. As we look forward, we will continue to manage the holdings of our investment portfolio with preservation of capital being the primary objective.

Page 18


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 hashave had a limited overall impact due to natural hedging. However, theany 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 likelypossible that 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 economicmacroeconomic 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 revolving credit facility. Our liquidity needs may change if overall economic conditions changeworsen 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 $26,004$12,993 for the first ninethree months of fiscal 2016,2017, a 17% decrease7% increase from the $31,196$12,092 provided during the first ninethree months of fiscal 2015.2016. While reflecting the effects of the timing of payments from customers and to suppliers and taxing authorities, this decreaseincrease also results in large part from the increase innet effects of (i) decreased inventory levels. The levels during the first quarter of inventory in our Life Science segment have beenfiscal 2017, compared to increased in anticipationlevels during the fiscal 2016 first quarter; and (ii) decreased accrued employee compensation costs during the first quarter of demand related to various initiatives, most notably further expansion intofiscal 2017, reflecting the Asian market.payment of discretionary bonuses and the timing of regularly scheduled payroll payments. Net cash flows from operating activities and cash on hand are anticipated to be adequate to fund working capital requirements, capital expenditures and dividends at the previously-noted reduced rate during the next 12 months.

Page 20


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 $67,690,$67,874, 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$2,383 remains payable to the sellers, pending the realization of tax benefits for certain net operating loss carryforwards in future tax returns.

Capital Resources

WeAs described in Notes 3 and 7 of the accompanying Condensed Consolidated Financial Statements, in connection with the acquisition of Magellan, 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 due March 31, 2021. In addition, we have a $30,000 revolving credit facility with a commercial bank that expires on March 31, 2021. As of JulyJanuary 31, 2016,2017, 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 revolving credit facility during the first ninethree months of fiscal 20162017 or during the full year of fiscal 2015.2016.

Our capital expenditures are estimated to range between approximately $3,000 to $4,000$5,000 for fiscal 2016,2017, with the actual amount dependingdependent 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 revolving credit facility discussed above.

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

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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, 2015.2016.

ITEM 4. CONTROLS AND PROCEDURES

As of June 30,December 31, 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 June 30,December 31, 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 thirdfirst 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 June 30,December 31, 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. The Company’s assessment of and conclusion on the effectiveness of its internal control over financial reporting did not, and is not required to include the internal controls of Magellan Biosciences, Inc., which was acquired during fiscal 2016 and the results of which have been included in the Company’s consolidated financial statements since the date of acquisition.

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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.

 

  10.1Form of Meridian Bioscience, Inc. Change in Control Agreement dated August 4, 2016 (filed herewith)
  10.2Letter Agreement dated July 26, 2016 between the Company and Richard 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 June 30,December 31, 2016 filed with the SEC on AugustFebruary 9, 2016,2017, formatted in XBRL includes: (i) Condensed Consolidated Statements of Operations for the three and nine months ended June 30,December 31, 2016 and 2015; (ii) Condensed Consolidated Statements of Comprehensive Income for the three and nine months ended June 30,December 31, 2016 and 2015; (iii) Condensed Consolidated Statements of Cash Flows for the ninethree months ended June 30,December 31, 2016 and 2015; (iv) Condensed Consolidated Balance Sheets as of June 30,December 31, 2016 and September 30, 2015;2016; (v) Condensed Consolidated Statement of Shareholders’ Equity for the ninethree months ended June 30,December 31, 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: AugustFebruary 9, 20162017 By:   

/s/ Melissa A. Lueke

  Melissa A. Lueke
  

Executive Vice President and Chief Financial Officer

(Principal Financial and Accounting Officer)

 

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