SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

Form10-Q

 

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

For the Quarterly Period Ended DecemberMarch 31, 20162017

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      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 RegulationS-T during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).    Yes  ☒  ☒    No  ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, anon-accelerated filer, or a smaller reporting company, or an emerging growth company. See definitions of “large accelerated filer,” “accelerated filer” andfiler,” “smaller reporting company,” and “emerging growth company” in Rule12b-2 of the Exchange Act.

 

Large accelerated filer   Accelerated filer 
Non-accelerated filer   Smaller reporting company 
Emerging growth company

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule12b-2 of the Exchange Act).    Yes  ☐    No  ☒

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

 

Class

 

Outstanding January 31,April 30, 2017

Common Stock, no par value 42,202,39742,202,807


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 Six Months Ended DecemberMarch  31, 20162017 and 20152016

   1 
  

Condensed Consolidated Statements of Comprehensive Income Three and Six Months Ended DecemberMarch 31, 20162017 and 20152016

   2 
  

Condensed Consolidated Statements of Cash Flows ThreeSix Months Ended DecemberMarch 31, 20162017 and 20152016

   3 
  

Condensed Consolidated Balance Sheets DecemberMarch  31, 20162017 and September 30, 2016

   4-5 
  

Condensed Consolidated Statement of Changes in Shareholders’ Equity ThreeSix Months Ended DecemberMarch 31, 20162017

   6 
  

Notes to Condensed Consolidated Financial Statements

   7-127-13 
Item 2.  Management’s Discussion and Analysis of Financial Condition and Results of Operations   13-1914-22 
Item 3.  Quantitative and Qualitative Disclosures About Market Risk   2022 
Item 4.  Controls and Procedures   2022 
PART II.  OTHER INFORMATION  
Item 1A.  Risk Factors   2023 
Item 6.  Exhibits   2023 
Signature     2123 

FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form10-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 or in protecting its intellectual property. Meridian relies on proprietary, patented and licensed technologies. 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, 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 Form10-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 Six Months Ended 
  Three Months Ended
December 31,
   March 31, March 31, 
  2016 2015   2017 2016 2017 2016 

NET REVENUES

  $46,809  $47,160   $54,125  $51,259  $100,934  $98,419 

COST OF SALES

   17,359  15,577    20,594  17,687  37,953  33,264 
  

 

  

 

   

 

  

 

  

 

  

 

 

GROSS PROFIT

   29,450  31,583    33,531  33,572  62,981  65,155 
  

 

  

 

   

 

  

 

  

 

  

 

 

OPERATING EXPENSES

        

Research and development

   3,405  3,381    3,907  3,129  7,312  6,510 

Selling and marketing

   7,514  6,443    8,012  7,210  15,526  13,653 

General and administrative

   8,446  8,173    7,426  6,875  15,872  14,769 

Acquisition-related costs

   —    1,202   —    1,481 
  

 

  

 

   

 

  

 

  

 

  

 

 

Total operating expenses

   19,365  17,997    19,345  18,416  38,710  36,413 
  

 

  

 

   

 

  

 

  

 

  

 

 

OPERATING INCOME

   10,085  13,586    14,186  15,156  24,271  28,742 

OTHER INCOME (EXPENSE)

        

Interest income

   22  17    29  3  51  20 

Interest expense

   (423  —      (408 (43 (831 (43

Other, net

   (25 96    383  (324 358  (228
  

 

  

 

   

 

  

 

  

 

  

 

 

Total other income (expense)

   (426 113    4  (364 (422 (251
  

 

  

 

   

 

  

 

  

 

  

 

 

EARNINGS BEFORE INCOME TAXES

   9,659  13,699    14,190  14,792  23,849  28,491 

INCOME TAX PROVISION

   3,380  4,806    4,878  5,701  8,258  10,507 
  

 

  

 

   

 

  

 

  

 

  

 

 

NET EARNINGS

  $6,279  $8,893   $9,312  $9,091  $15,591  $17,984 
  

 

  

 

   

 

  

 

  

 

  

 

 

BASIC EARNINGS PER COMMON SHARE

  $0.15  $0.21   $0.22  $0.22  $0.37  $0.43 

DILUTED EARNINGS PER COMMON SHARE

  $0.15  $0.21   $0.22  $0.21  $0.37  $0.42 

WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING - BASIC

   42,159  41,947    42,202  42,053  42,177  41,984 

EFFECT OF DILUTIVE STOCK OPTIONS AND RESTRICTED SHARE UNITS

   376  380    366  372  362  376 
  

 

  

 

   

 

  

 

  

 

  

 

 

WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING - DILUTED

   42,535  42,327    42,568  42,425  42,539  42,360 
  

 

  

 

   

 

  

 

  

 

  

 

 

ANTI-DILUTIVE SECURITIES:

        

Common share options and restricted share units

   715  450    1,001  444  871  476 
  

 

  

 

   

 

  

 

  

 

  

 

 

DIVIDENDS DECLARED PER COMMON SHARE

  $0.20  $0.20   $0.125  $0.20  $0.325  $0.40 
  

 

  

 

   

 

  

 

  

 

  

 

 

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
December 31,
   Three Months Ended
March 31,
 Six Months Ended
March 31,
 
  2016 2015   2017 2016 2017 2016 

NET EARNINGS

  $6,279  $8,893   $9,312  $9,091  $15,591  $17,984 

Other comprehensive income (loss):

        

Foreign currency translation adjustment

   (1,423 (787   512  (78 (911 (865

Unrealized gain on cash flow hedge

   1,560   —   

Unrealized gain (loss) on cash flow hedge

   128  (694 1,688  (694

Income taxes related to items of other comprehensive income

   (589  —      (24 243  (613 243 
  

 

  

 

   

 

  

 

  

 

  

 

 

Other comprehensive income (loss), net of tax

   (452 (787   616  (529 164  (1,316
  

 

  

 

   

 

  

 

  

 

  

 

 

COMPREHENSIVE INCOME

  $5,827  $8,106   $9,928  $8,562  $15,755  $16,668 
  

 

  

 

   

 

  

 

  

 

  

 

 

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)

 

Three Months Ended December 31,

  2016 2015 

Six Months Ended March 31,

  2017 2016 

CASH FLOWS FROM OPERATING ACTIVITIES

      

Net earnings

  $6,279  $8,893   $15,591  $17,984 

Non-cash items included in net earnings:

      

Depreciation of property, plant and equipment

   1,078  896    2,154  1,785 

Amortization of intangible assets

   968  388    1,904  762 

Amortization of deferred instrument costs

   257  281    500  544 

Stock-based compensation

   1,884  1,611    2,360  2,290 

Deferred income taxes

   2,091  433    1,982  (306

Change in current assets

   1,616  (1,186

Change in current liabilities

   (869 834 

Losses on long-lived assets

   —    659 

Change in current assets, net of acquisition

   4,634  (6,905

Change in current liabilities, net of acquisition

   (3,269 1,505 

Other, net

   (311 (58   (724 143 
  

 

  

 

   

 

  

 

 

Net cash provided by operating activities

   12,993  12,092    25,132  18,461 
  

 

  

 

   

 

  

 

 

CASH FLOWS FROM INVESTING ACTIVITIES

      

Purchase of property, plant and equipment

   (1,392 (776   (2,273 (1,524

Purchase of equity method investment

   —    (600   —    (600

Acquisition of Magellan, net of cash acquired

   —    (62,177

Purchase of intangibles and other assets

   —    (16   —    (16
  

 

  

 

   

 

  

 

 

Net cash used for investing activities

   (1,392 (1,392   (2,273 (64,317
  

 

  

 

   

 

  

 

 

CASH FLOWS FROM FINANCING ACTIVITIES

      

Dividends paid

   (8,440 (8,407   (13,715 (16,817

Payment on term loan

   (750  —   

Proceeds from term loan, net of issuance costs

   —    59,842 

Payments on term loan

   (1,500  —   

Proceeds and tax benefits from exercises of stock options

   301  1,470    303  1,969 
  

 

  

 

   

 

  

 

 

Net cash used for financing activities

   (8,889 (6,937

Net cash (used for) provided by financing activities

   (14,912 44,994 
  

 

  

 

   

 

  

 

 

Effect of Exchange Rate Changes on Cash and Equivalents

   (662 (314   (428 (165
  

 

  

 

   

 

  

 

 

Net Increase in Cash and Equivalents

   2,050  3,449 

Net Increase (Decrease) in Cash and Equivalents

   7,519  (1,027

Cash and Equivalents at Beginning of Period

   47,226  49,973    47,226  49,973 
  

 

  

 

   

 

  

 

 

Cash and Equivalents at End of Period

  $49,276  $53,422   $54,745  $48,946 
  

 

  

 

   

 

  

 

 

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,
2017
(Unaudited)
   September 30,
2016
 
  
  December 31,
2016
(Unaudited)
   September 30,
2016
   

CURRENT ASSETS

        

Cash and equivalents

  $49,276   $47,226   $54,745   $47,226 

Accounts receivable, less allowances of $346 and $334

   24,278    27,102 

Accounts receivable, less allowances of $381 and $334

   26,980    27,102 

Inventories

   44,709    45,057    42,375    45,057 

Prepaid expenses and other current assets

   7,785    7,406    4,694    7,406 
  

 

   

 

   

 

   

 

 

Total current assets

   126,048    126,791    128,794    126,791 
  

 

   

 

   

 

   

 

 

PROPERTY, PLANT AND EQUIPMENT, at Cost

        

Land

   1,147    1,155    1,149    1,155 

Buildings and improvements

   31,595    31,487    31,800    31,487 

Machinery, equipment and furniture

   45,712    45,085    46,521    45,085 

Construction in progress

   1,953    1,947    1,784    1,947 
  

 

   

 

   

 

   

 

 

Subtotal

   80,407    79,674    81,254    79,674 

Less: accumulated depreciation and amortization

   49,975    49,224    51,078    49,224 
  

 

   

 

   

 

   

 

 

Net property, plant and equipment

   30,432    30,450    30,176    30,450 
  

 

   

 

   

 

   

 

 

OTHER ASSETS

        

Goodwill

   60,705    61,982    60,836    61,982 

Other intangible assets, net

   29,348    29,855    28,457    29,855 

Restricted cash

   1,000    1,000    1,000    1,000 

Deferred instrument costs, net

   1,339    1,392    1,291    1,392 

Fair value of interest rate swap

   831    —      960    —   

Other assets

   352    353    388    353 
  

 

   

 

   

 

   

 

 

Total other assets

   93,575    94,582    92,932    94,582 
  

 

   

 

   

 

   

 

 

TOTAL ASSETS

  $250,055   $251,823   $251,902   $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

 

  December 31,
2016
(Unaudited)
 September 30,
2016
   March 31,
2017
(Unaudited)
 September 30,
2016
 

CURRENT LIABILITIES

      

Accounts payable

  $7,511  $7,627   $6,416  $7,627 

Accrued employee compensation costs

   5,064  7,106    4,082  7,106 

Current portion of acquisition consideration

   653   —   

Other accrued expenses

   2,833  2,606    2,531  2,606 

Current portion of long-term debt

   4,125  3,750    4,500  3,750 

Income taxes payable

   1,511  1,482    1,716  1,482 
  

 

  

 

   

 

  

 

 

Total current liabilities

   21,044  22,571    19,898  22,571 
  

 

  

 

   

 

  

 

 

NON-CURRENT LIABILITIES

      

Acquisition consideration

   2,383  2,383    1,730  2,383 

Non-current compensation liabilities

   2,458  2,305 

Post-employment benefits

   2,362  2,305 

Fair value of interest rate swap

   —    729    —    729 

Long-term debt

   53,495  54,610    52,379  54,610 

Deferred income taxes

   4,943  2,753    4,705  2,753 
  

 

  

 

   

 

  

 

 

Total non-current liabilities

   63,279  62,780    61,176  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, 42,202,067 and 42,106,587 shares issued, respectively

   —     —   

Common shares, no par value; 71,000,000 shares authorized, 42,202,397 and 42,106,587 shares issued, respectively

   —     —   

Additional paid-in capital

   124,229  122,356    124,672  122,356 

Retained earnings

   47,471  49,632    51,508  49,632 

Accumulated other comprehensive loss

   (5,968 (5,516   (5,352 (5,516
  

 

  

 

   

 

  

 

 

Total shareholders’ equity

   165,732  166,472    170,828  166,472 
  

 

  

 

   

 

  

 

 

TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY

  $250,055  $251,823   $251,902  $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, 2016

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

Cash dividends paid

   —      —    (8,440  —    (8,440   —      —    (13,715  —    (13,715

Exercise of stock options

   18    (11  —     —    (11   18    (44  —     —    (44

Conversion of restricted share units

   77    —     —     —     —      77    —     —     —     —   

Stock compensation expense

   —      1,884   —     —    1,884    —      2,360   —     —    2,360 

Net earnings

   —      —    6,279   —    6,279    —      —    15,591   —    15,591 

Foreign currency translation adjustment

   —      —     —    (1,423 (1,423   —      —     —    (911 (911

Hedging activity, net of tax

   —      —     —    971  971    —      —     —    1,075  1,075 
  

 

   

 

  

 

  

 

  

 

   

 

   

 

  

 

  

 

  

 

 

Balance at December 31, 2016

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

Balance at March 31, 2017

   42,202   $124,672  $51,508  $(5,352 $170,828 
  

 

   

 

  

 

  

 

  

 

   

 

   

 

  

 

  

 

  

 

 

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 DecemberMarch 31, 2016,2017, the results of its operations for the three and six month periods ended DecemberMarch 31, 20162017 and 2015,2016, and its cash flows for the threesix month periods ended DecemberMarch 31, 20162017 and 2015.2016. These statements should be read in conjunction with the consolidated financial statements and footnotes thereto included in the Company’s fiscal 2016 Annual Report on Form10-K. Financial information as of September 30, 2016 has been derived from the Company’s audited consolidated financial statements. The results of operations for interim periods are not necessarily indicative of the results to be expected for the year.

 

2.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 2016 Annual Report on Form10-K.

Recent Accounting Pronouncements –

In May 2014, the FASB issued ASUNo. 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). While 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 February 2016, the FASB issued ASU2016-02,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 completedexpects to begin its assessment of the impact that adoption of this guidance will have on its financial statements.statements in fiscal 2018.

In March 2016, the FASB issued ASU2016-09,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 ofassessed the impact that adoption of this guidance will have, and believes that the impact will primarily relate to the treatment of the differences between stock compensation expense recorded in the Company’s financial statements and the stock compensation ultimately deducted on its financial statements.tax returns. The tax effect of such differences is currently recorded in additionalpaid-in capital and reflected within the financing activities section of the statement of cash flows but upon adoption of this guidance will be required to be recorded directly to income tax expense and reflected within the operating activities section of the statement of cash flows. While the impact of this guidance, which the Company plans to adopt on a prospective

Page 7


basis at the beginning of fiscal 2018, is dependent on numerous factors (e.g., the market price of the Company’s common stock on the equity award grant date, the exercise/lapse dates of equity awards, and the market price of the Company’s common stock on such exercise/lapse dates), based on currently outstanding awards and the current market price of the Company’s common stock, the effect on the Company’s annual tax provision is not expected to be material.

In August 2016, the FASB issued ASU2016-15,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 ASU2016-16,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 completedbegun 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.

In January 2017, the FASB issued ASU2017-04,Simplifying the Test for Goodwill Impairment, which serves to simplify the process of testing for goodwill impairment by eliminating the “Step 2” comparison of a reporting unit’simplied fair value to its carrying amount. The guidance requires an entity to compare a reporting unit’s fair value to its carrying amount, and if the carrying amount exceeds the fair value, an impairment equal to the excess carrying amount is recorded; no Step 2 implied fair value comparison is required. Adoption and implementation of the guidance is not required by the Company until the beginning of fiscal 2021, although early adoption is permitted.

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

 

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 $67,874, utilizing the proceeds from a $60,000 five-year term loan and cash and equivalents on hand. An amount of the acquisition consideration totaling $2,383 remains payable to the sellers, pending the realization of tax benefits for certain net operating loss carryforwards in future tax returns, which is included within non-current liabilities on our Condensed Consolidated Balance Sheet.returns. Headquartered near Boston, Massachusetts, Magellan is a leading manufacturer ofFDA-cleared products for the testing of blood to diagnose lead poisoning in children and adults. Magellan is the leading provider ofpoint-of-care lead testing systems in the U.S.

Since the consideration paid exceedsexceeded the preliminary fair value of the net assets acquired, goodwill in the amount of $40,572$40,591 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 six months ended March 31, 2016 include $1,105 of transaction costs related to the Magellan acquisition, which are reflected as Operating Expenses.

The Magellan results of operations, which are included in our Condensed Consolidated StatementStatements of Operations for the three and six months ended DecemberMarch 31, 20162017 and reported as part of the Diagnostics operating segment, include $726$675 and $1,387, respectively, 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.

Page 8


The results of Magellan included in the Company’s consolidated results for the three and six months ended DecemberMarch 31, 2016 include net revenues and net earnings from Magellan totaling $5,199 and $468, respectively, and reflect2017 are as follows, reflecting the items noted above and excludeexcluding interest expense on the debt secured by Meridian in connection with the transaction.

transaction:

 

Page 8


   Three
Months
Ended
March 31,
   Six
Months
Ended
March 31,
 
   2017   2017 

Net Revenues

  $3,645   $8,844 

Net Earnings

  $(280  $188 

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

 

  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

  $3,400   $—     $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

   300    —      300    300    —      300 

Property, plant and equipment

   2,800    (200   2,600    2,800    (200   2,600 

Goodwill

   42,800    (2,200   40,600    42,800    (2,200   40,600 

Other intangible assets (estimated useful life):

            

Customer relationships (15 years)

   12,600    300    12,900    12,600    300    12,900 

Technology (10 years)

   10,600    300    10,900    10,600    300    10,900 

Non-compete agreements (2 years)

   700    —      700    700    —      700 

Trade names (approximate 9 year weighted average)

   3,700    (700   3,000    3,700    (700   3,000 
  

 

   

 

   

 

   

 

   

 

   

 

 
   80,000    (2,500   77,500    80,000    (2,500   77,500 

Fair value of liabilities assumed -

            

Accounts payable and accrued expenses

   1,600    100    1,700    1,600    100    1,700 

Deferred income tax liabilities

   10,600    (2,700   7,900    10,600    (2,700   7,900 
  

 

   

 

   

 

   

 

   

 

   

 

 

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

  $67,800   $100   $67,900   $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.

Page 9


The consolidated pro forma results of the combined entities of Meridian and Magellan, had the acquisition date been October 1, 2015, are as follows for the periods indicated:

 

  Three Months   Six Months 
  Three Months Ended
December 31,
   Ended March 31,   Ended March 31, 
  2016   2015   2017   2016   2017   2016 

Net Revenues

  $46,809   $51,095   $54,125   $54,962   $100,934   $106,057 

Net Earnings

  $6,279   $8,517   $9,312   $9,297   $15,591   $17,856 

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, 2015, together with the consequential tax effects thereon:

 

 (i)remove the effect of transaction costs incurred by the Company ($1,105 in both the three and six months ended March 31, 2016);

(ii)reflect the additional depreciation and amortization that would have been charged in connection with the preliminary fair value adjustments to inventory, property, plant and equipment, and identifiable intangible assets ($869688 and $1,556 in the quarterthree and six months ended DecemberMarch 31, 2015)2016, respectively);

 

 (ii)(iii)reflect equity-based awards granted under the Company’s 2012 Stock Incentive Plan to certain Magellan employees in accordance with executed employment agreements, and to certain Meridian employees to reward them for their efforts in connection with the transaction ($11044 and $90 in the quarterthree and six months ended DecemberMarch 31, 2015)2016, respectively); and

 

 (iii)(iv)reflect the interest expense that would have been incurred on the Company’s $60,000 term note ($429423 and $852 in the quarterthree and six months ended DecemberMarch 31, 2015)2016, respectively).

 

Page 9


4.Cash and Equivalents

Cash and equivalents include the following components:

 

  December 31, 2016   September 30, 2016   March 31, 2017   September 30, 2016 
  Cash and
Equivalents
   Other
Assets
   Cash and
Equivalents
   Other
Assets
   Cash and
Equivalents
   Other
Assets
   Cash and
Equivalents
   Other
Assets
 

Overnight repurchase agreements

  $15,628   $—     $9,988   $—     $8,839   $—     $9,988   $—   

Institutional money market funds

   10,006    —      10,020    —      20,024    —      10,020    —   

Cash on hand -

                

Restricted

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

Unrestricted

   23,642    —      27,218    —      25,882    —      27,218    —   
  

 

   

 

   

 

   

 

   

 

   

 

   

 

   

 

 

Total

  $49,276   $1,000   $47,226   $1,000   $54,745   $1,000   $47,226   $1,000 
  

 

   

 

   

 

   

 

   

 

   

 

   

 

   

 

 

 

Page 10


5.Inventories

Inventories are comprised of the following:

 

  December 31,
2016
   September 30,
2016
   March 31,
2017
   September 30,
2016
 

Raw materials

  $7,642   $7,639   $7,192   $7,639 

Work-in-process

   13,535    13,146    12,890    13,146 

Finished goods - instruments

   2,113    2,378    1,858    2,378 

Finished goods - kits and reagents

   21,419    21,894    20,435    21,894 
  

 

   

 

   

 

   

 

 

Total

  $44,709   $45,057   $42,375   $45,057 
  

 

   

 

   

 

   

 

 

 

6.Intangible Assets

A summary of our acquired intangible assets subject to amortization, as of DecemberMarch 31, 20162017 and September 30, 2016, is as follows:

 

   December 31, 2016   September 30, 2016 
   Gross
Carrying
Value
   Accumulated
Amortization
   Gross
Carrying
Value
   Accumulated
Amortization
 

Manufacturing technologies, core products and cell lines

  $22,230   $11,800   $21,921   $11,540 

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

   720    270    680    170 
  

 

 

   

 

 

   

 

 

   

 

 

 
  $56,270   $26,922   $56,023   $26,168 
  

 

 

   

 

 

   

 

 

   

 

 

 

Page 10


   March 31, 2017   September 30, 2016 
   Gross
Carrying
Value
   Accumulated
Amortization
   Gross
Carrying
Value
   Accumulated
Amortization
 

Manufacturing technologies, core products and cell lines

  $22,245   $12,115   $21,921   $11,540 

Trade names, licenses and patents

   8,584    3,874    9,037    3,947 

Customer lists, customer relationships and supply agreements

   24,322    11,065    24,385    10,511 

Non-compete agreements

   720    360    680    170 
  

 

 

   

 

 

   

 

 

   

 

 

 
  $55,871   $27,414   $56,023   $26,168 
  

 

 

   

 

 

   

 

 

   

 

 

 

The actual aggregate amortization expense for these intangible assets was $968$936 and $388$374 for the three months ended DecemberMarch 31, 2017 and 2016, respectively, and 2015,$1,904 and $762 for the six months ended March 31, 2017 and 2016, respectively. The estimated aggregate amortization expense for these intangible assets for each of the fiscal years through fiscal 2022 is as follows: remainder of fiscal 2017 – $2,794,$1,866, fiscal 2018 – $3,524,$3,529, fiscal 2019 – $3,303,$3,308, fiscal 2020 – $3,144,$3,148, fiscal 2021 – $2,560, and fiscal 2022 – $2,164.$2,182.

 

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 the five succeeding fiscal years are as follows: remainder of fiscal 2017 – $3,000,$2,250, fiscal 2018 – $4,500, fiscal 2019 – $5,250, fiscal 2020 – $6,000, and fiscal 2021 – $39,000. In light of the term loan’s interest being determined on a variable rate basis, the fair value of the term loan at DecemberMarch 31, 20162017 approximates the current carrying value reflected in the accompanying Condensed Consolidated Balance Sheet.

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 of 2.76%. With an initial notional balance of $60,000, the interest rate swap has beenwas established with critical terms identical to those of the term loan, including (i) notional reduction amounts and dates; (ii) LIBOR settlement rates;

Page 11


(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 DecemberMarch 31, 2016,2017, the fair value of the interest rate swap was an asset of $831,$960, and is reflected as anon-current asset 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 maintainmaintains 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 DecemberMarch 31, 20162017 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 DecemberMarch 31, 2016,2017, 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 SegmentSegments 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.science research and industrial components. Our principal businesses are (i) the development, manufacture and distribution of diagnostic test kits primarily for gastrointestinal, viral, respiratory and 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 researchersorganizations in the life science andagri-bio industries engaged in research, and by other diagnosticdiagnostics manufacturers.

Our reportable segments are Diagnostics and Life Science. The Diagnostics segment consists of manufacturing operations for infectious disease products in Cincinnati, Ohio; Magellan’s manufacturing operations for products detecting elevated lead levels in blood in Billerica, Massachusetts (near Boston); and the sale and distribution of diagnostics products domestically and abroad. This segment’s products are used by hospitals, reference labs and physician offices to detect infectious diseases and 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 12%15% and 16% of consolidated accounts receivable at DecemberMarch 31, 20162017 and September 30, 2016, respectively. Revenues from these two distributor customers accounted for 23%33% and 39%26% of the Diagnostics segment third-party revenues during the three months ended DecemberMarch 31, 20162017 and 2015,2016, respectively, and 28% and 33% during the six months ended March 31, 2017 and 2016, respectively. These distributors represented 17%23% and 29%19% of consolidated revenues for the fiscal 2017 and 2016 firstsecond quarters, respectively.respectively, and 20% and 24% for the respectiveyear-to-date six month periods.

Within our Life Science segment, two diagnostic manufacturing customers accounted for 19%21% and 18% of the segment’s third-party revenues during the three months ended DecemberMarch 31, 2017 and 2016, respectively, and 2015,20% and 18% during the six months ended March 31, 2017 and 2016, 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 December 31, 2016

  

Three Months Ended March 31, 2017

Three Months Ended March 31, 2017

 

Net revenues -

                

Third-party

  $33,808   $13,001   $—     $46,809   $37,772   $16,353   $—     $54,125 

Inter-segment

   79    125    (204   —      128    107    (235   —   

Operating income

   6,643    3,267    175    10,085    9,595    4,571    20    14,186 

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

        

Goodwill (March 31, 2017)

   41,841    18,995    —      60,836 

Other intangible assets, net (March 31, 2017)

   26,516    1,941    —      28,457 

Total assets (March 31, 2017)

   185,094    66,894    (86   251,902 

Three Months Ended March 31, 2016

Three Months Ended March 31, 2016

 

Net revenues -

                

Third-party

  $35,301   $11,859   $—     $47,160   $37,354   $13,905   $—     $51,259 

Inter-segment

   71    367    (438   —      84    387    (471   —   

Operating income

   10,330    3,236    20    13,586    11,196    4,154    (194   15,156 

Goodwill (September 30, 2016)

   42,608    19,374    —      61,982    42,608    19,374    —      61,982 

Other intangible assets, net (September 30, 2016)

   27,534    2,321    —      29,855    27,534    2,321    —      29,855 

Total assets (September 30, 2016)

   185,241    66,624    (42   251,823    185,241    66,624    (42   251,823 

Six Months Ended March 31, 2017

Six Months Ended March 31, 2017

 

Net revenues -

        

Third-party

  $71,580   $29,354   $—     $100,934 

Inter-segment

   207    232    (439   —   

Operating income

   16,238    7,838    195    24,271 

Six Months Ended March 31, 2016

Six Months Ended March 31, 2016

 

Net revenues -

        

Third-party

  $72,655   $25,764   $—     $98,419 

Inter-segment

   155    754    (909   —   

Operating income

   21,526    7,390    (174   28,742 

 

(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 Form10-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 Overview

The firstsecond quarter of fiscal 2017 was characterized by strong performance from our Life Science and Magellan business units, with significant weakness in our core diagnostics businessimprovement in the U.S. (partCompany’s overall results compared to those 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, ofwith both our Diagnostics and Life Science reportable segments reflecting revenue increases over both the fiscal 2017 first quarter and the comparable fiscal 2016 on a constant-currency basis. While we have implementedsecond quarter. These improvements reflect the benefits of measures taken since late in fiscal 2016 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 actionwell as actions taken to align resources, reduce expenses and optimize investments in product development. The resultsRevenues for the second quarter of fiscal 2017 were 16% higher than the first fiscalquarter. Similarly, net earnings for the second quarter have led to the downward revision to ourof fiscal 2017 revenue and earnings guidance, andwere 48% higher than the annual indicated dividend rate has been reduced (as more fully discussed in the Liquidity and Capital Resources section below), better aligning with our stated dividend payout range and enabling the Company to fund global expansion and new product development.first quarter.

Three Months Ended DecemberMarch 31, 20162017

Net earnings for the firstsecond quarter of fiscal 2017 decreased 29%increased 2% to $6,279,$9,312, or $0.15$0.22 per diluted share, from net earnings for the firstsecond quarter of fiscal 2016 of $8,893,$9,091, or $0.21 per diluted share. Reflected within the fiscal 2016 quarterly results are transaction costs related to acquisition activity, including the 2016 Magellan acquisition ($1,000, or $0.02 per diluted share, net of tax). Consolidated revenues decreased 1%increased 6% to $46,809$54,125 for the firstsecond quarter of fiscal 2017 compared to the same period of the prior year (flat(also 6% on a constant-currency basis).

Revenues for the Diagnostics segment for the firstsecond quarter of fiscal 2017 decreased 4%increased 1% compared to the firstsecond quarter of fiscal 2016 (also down 4%(increased 2% on a constant-currency basis), comprised of a 22%2% decrease in molecular products and a 2% increase innon-molecular products, including $5,199$3,645 of Magellan revenues. With an 11%a 25% increase in its immunoassay components business and an 8%a 4% increase in its molecular components business, revenues of our Life Science segment increased by 10%18% during the firstsecond quarter of fiscal 2017 compared to the firstsecond quarter of fiscal 2016 increasing 12%(increasing 20% on a constant-currency basis.basis).

Six Months Ended March 31, 2017

For the six month period ended March 31, 2017, net earnings decreased 13% to $15,591, or $0.37 per diluted share, compared to net earnings for the comparable fiscal 2016 period of $17,984, or $0.42 per diluted share. Reflected within theyear-to-date fiscal 2016 results are transaction costs related to acquisition activity, including the 2016 Magellan acquisition ($1,233, or $0.03 per diluted share, net of tax). Consolidated revenues increased 3% to $100,934 for the first six months of fiscal 2017 compared to the same period of the prior year (also 3% on a constant-currency basis).

Revenues for the Diagnostics segment for the first six months of fiscal 2017 decreased 1% compared to the first six months of fiscal 2016 (also 1% on a constant-currency basis), comprised of a 12% decrease in molecular products and a 2% increase innon-molecular products, including $8,844 of Magellan revenues. With a 19% increase in its immunoassay components business and a 6% increase in its molecular components business, revenues of our Life Science segment increased by 14% during the first six months of fiscal 2017 compared to the first six months of fiscal 2016 (increasing 16% on a constant-currency basis).

 

Page 1314


USE OFNON-GAAP MEASURES

We have supplemented our reported GAAP financial information with 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 anon-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 ofnon-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,
 
   2017   2016   2017   2016 

Net Earnings -

        

U.S. GAAP basis

  $9,312   $9,091   $15,591   $17,984 

Acquisition-related costs (1)

   —      1,000    —      1,233 
  

 

 

   

 

 

   

 

 

   

 

 

 

Adjusted earnings

  $9,312   $10,091   $15,591   $19,217 
  

 

 

   

 

 

   

 

 

   

 

 

 

Net Earnings per Basic Common Share -

        

U.S. GAAP basis

  $0.22   $0.22   $0.37   $0.43 

Acquisition-related costs (1)

   —      0.02    —      0.03 
  

 

 

   

 

 

   

 

 

   

 

 

 

Adjusted Basic EPS

  $0.22   $0.24   $0.37   $0.46 
  

 

 

   

 

 

   

 

 

   

 

 

 

Net Earnings per Diluted Common Share -

        

U.S. GAAP basis

  $0.22   $0.21   $0.37   $0.42 

Acquisition-related costs (1)

   —      0.02    —      0.03 
  

 

 

   

 

 

   

 

 

   

 

 

 

Adjusted Diluted EPS (2)

  $0.22   $0.24   $0.37   $0.45 
  

 

 

   

 

 

   

 

 

   

 

 

 

(1)Acquisition-related 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.

Thesenon-GAAP measures may be different fromnon-GAAP measures used by other companies. In addition, thesenon-GAAP measures are not based on any comprehensive set of accounting rules or principles.Non-GAAP measures have limitations, in that they do not reflect all amounts associated with our results as determined in accordance with U.S. GAAP. Therefore, these measures should only be used to evaluate our results in conjunction with corresponding GAAP measures.

Page 15


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, with products sold and distributed in the countries comprising North and Latin America (the “Americas”); Europe, Middle East and Africa (“EMEA”); and other countries outside of the Americas and EMEA (rest of the world, or “ROW”). A full description of our segments is set forth in Note 8 of the 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 December 31,   Three Months Ended March 31, Six Months Ended March 31, 
  2016 2015 Inc (Dec)   2017 2016 Inc (Dec) 2017 2016 Inc (Dec) 

Diagnostics -

           

Americas

  $27,569  $30,115  (8)%   $31,842  $31,864  —   $59,411  $61,979  (4)% 

EMEA

   5,662  4,649  22   5,013  4,882  3 10,675  9,531  12

ROW

   577  537  7   917  608  51 1,494  1,145  30
  

 

  

 

  

 

   

 

  

 

  

 

  

 

  

 

  

 

 

Total Diagnostics

   33,808  35,301  (4)%    37,772  37,354  1 71,580  72,655  (1)% 
  

 

  

 

  

 

   

 

  

 

  

 

  

 

  

 

  

 

 

Life Science -

           

Americas

   5,399  5,103  6   5,732  6,356  (10)%  11,131  11,459  (3)% 

EMEA

   4,898  4,536  8   6,722  4,614  46 11,620  9,150  27

ROW

   2,704  2,220  22   3,899  2,935  33 6,603  5,155  28
  

 

  

 

  

 

   

 

  

 

  

 

  

 

  

 

  

 

 

Total Life Science

   13,001  11,859  10   16,353  13,905  18 29,354  25,764  14
  

 

  

 

  

 

   

 

  

 

  

 

  

 

  

 

  

 

 

Consolidated

  $46,809  $47,160  (1)%   $54,125  $51,259  6 $100,934  $98,419  3
  

 

  

 

  

 

   

 

  

 

  

 

  

 

  

 

  

 

 

% of total revenues -

           

Diagnostics

   72 75    70 73  71 74 

Life Science

   28 25    30 27  29 26 
  

 

  

 

    

 

  

 

   

 

  

 

  

Total

   100 100    100 100  100 100 
  

 

  

 

    

 

  

 

   

 

  

 

  

Ex-Americas

   30 25    31 25  30 25 
  

 

  

 

    

 

  

 

   

 

  

 

  

 

Page 1416


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 revenues, are shown below.

 

  Three Months Ended December 31,   Three Months Ended March 31, Six Months Ended March 31, 
  2016 2015 Inc (Dec)   2017 2016 Inc (Dec) 2017 2016 Inc (Dec) 

Diagnostics -

           

Molecular

  $7,711  $9,836  (22)%   $9,477  $9,665  (2)%  $17,188  $19,501  (12)% 

Non-molecular

   26,097  25,465  2   28,295  27,689  2 54,392  53,154  2
  

 

  

 

  

 

   

 

  

 

  

 

  

 

  

 

  

 

 

Total Diagnostics

  $33,808  $35,301  (4)%   $37,772  $37,354  1 $71,580  $72,655  (1)% 
  

 

  

 

  

 

   

 

  

 

  

 

  

 

  

 

  

 

 

Life Science -

           

Molecular components

  $5,116  $4,749  8  $5,339  $5,116  4 $10,455  $9,865  6

Immunoassay components

   7,885  7,110  11   11,014  8,789  25 18,899  15,899  19
  

 

  

 

  

 

   

 

  

 

  

 

  

 

  

 

  

 

 

Total Life Science

  $13,001  $11,859  10  $16,353  $13,905  18 $29,354  $25,764  14
  

 

  

 

  

 

   

 

  

 

  

 

  

 

  

 

  

 

 

% of Diagnostics revenues -

           

Molecular

   23 28    25 26  24 27 

Non-molecular

   77 72    75 74  76 73 
  

 

  

 

    

 

  

 

   

 

  

 

  

Total Diagnostics

   100 100    100 100  100 100 
  

 

  

 

    

 

  

 

   

 

  

 

  

% of Life Science revenues -

           

Molecular components

   39 40    33 37  36 38 

Immunoassay components

   61 60    67 63  64 62 
  

 

  

 

    

 

  

 

   

 

  

 

  

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 22%2% to $7,711$9,477 for the firstsecond quarter of fiscal 2017 (also 22%2% on a constant-currency basis), and decreased 12% to $17,188 for the six monthyear-to-date period (also 12% on a constant-currency basis). This decrease reflects the ongoing increased competition within the molecular-based testing market, most notably within the market forC. difficile testing.

We have over 1,500nearly 1,550 customer account placements. Of these account placements, approximatelyover 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 450approximately 475 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,key objective, as this makes it more difficult for competitors to attack our customers.we believe broader menu utilization lessens the risk of displacement by competitors.

 

Page 1517


We continue to invest in new product development for our molecular testing platform, and this platform now has nine commercialized tests spanning hospital acquired infections, women’s health, respiratory, sexually transmitted diseases, and tropical diseases. Ourillumigene Malaria test has been placed in nearly 100 accounts in the following commercialized tests:EMEA region for use as a screening test for travelers returning to Europe from endemic areas in Africa. We have initiated efforts to develop market channels in the endemic areas of Africa, and early results are encouraging.

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. pneumoniae; walking pneumonia) – commercialized in June 2013

5.illumigeneBordetella pertussis (whooping cough) – commercialized in March 2014

6.illumigeneChlamydia trachomatis – commercialized outside of U.S. in February 2015

7.illumigeneNeisseria 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. pneumoniae; walking pneumonia) – commercialized in June 2016

We believe that the diagnostic testing market, particularly in the U.S., 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, and duringcare. During the firstsecond quarter of fiscal 2017 we experienced 6%5% growth in all testing categories, other than the hyper-competitiveC. difficile arena.arena and 6% growth during the six monthyear-to-date period. 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.well-positioned. 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 for 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’snon-molecular products increased 2% in both the firstsecond quarter of fiscal 2017.2017 and on a six monthyear-to-date basis. These results reflect the addition of Magellan’s revenue, largely offset by decreased revenues in ourH. pyloriand other immunoassay product lines.

During the first quarter of fiscal 2017, revenuesRevenues from Magellan’s sales of products to test for elevated levels of lead in blood totaled $5,199. This level$3,645 and $8,844 during the second quarter of revenues reflects a 32% increase overfiscal 2017 and the six monthyear-to-date period, respectively. Compared to the three-month periodandsix-month periods ended DecemberMarch 31, 2015,2016, which waswere prior to Meridian’s ownership of Magellan.Magellan, these revenues were approximately flat and up approximately 17%, respectively. Magellan’s revenues for the second quarter of fiscal 2017 were adversely affected by distributor and international order patterns. Also, during the second quarter, Magellan executed distribution agreements with distributors in China and Kenya that are expected to contribute revenues during the second half of fiscal 2017.

During the firstsecond quarter of fiscal 2017, revenues from ourH. pylori products decreased 18% (also 18%7% (6% on a constant-currency basis) to $7,156.$7,725. These revenues decreased 13% to $14,881 during the first six months of fiscal 2017 (12% on a constant-currency basis). In fiscal 2016, we employedbulk-buy sales promotionsprograms (also referred to as “stock-and-block”“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,these programs, we expect ourH. pylorirevenue to return to flat to low single-digit growth forduring the second half of 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 believe there are ongoing benefits to be realized from our partnerships with managed care companies in promotingpromoting: (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. We recently introduced capabilities to identify resistance to Clarithromycin, the antibiotic commonly used to treatH. pylori. We believe that partnering the ability to diagnoseH. pylori and identify resistance is a strong competitive advantage.

The patents for ourH. pylori products are owned by us and expired in May 2016 in the U.S., and will expire in fiscalMay 2017 in countries outside the U.S. We expect competition with respect to ourH. pylori products to increase in fiscal 2017over the next 12 months, as we currently market the onlyFDA-cleared tests 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 mitigatedefend against competition, our product development pipeline includes multiple new product initiatives for the detection ofH. pylori. We are unable to provide assurances that we will be successful with any mitigationcompetition defense strategy or that any mitigationcompetition defense strategy will prevent an adverse effect on our future results of operations and liquidity, including revenues and gross profit.

 

Page 1618


During the firstsecond quarter of fiscal 2017, revenues from our other immunoassay products (includingC. difficile, foodborne and respiratory) decreased 18%14% (also 18%14% on a constant-currency basis) to $13,615. This decrease results$15,922. These revenues decreased 16% to $29,537 during the first six months of fiscal 2017 (also 16% on a constant-currency basis). These decreases result primarily from the effects of continued increased competition and distributor order patterns and the timing of our promotional “stock-and-block” programs in previous periods.patterns.

Life Science Products

During the firstsecond quarter of fiscal 2017, revenues from our Life Science segment increased 10%18%, with revenues from molecular component sales increasing 8%4% from the comparable fiscal 2016 quarter and revenues from immunoassay component sales increasing 11%25%. For the first six months of fiscal 2017, revenues from our Life Science segment increased 14%, with revenues from molecular component sales increasing 6% from theyear-to-date fiscal 2016 period and revenues from immunoassay component sales increasing 19%. Our molecular component business’ growth was negatively impacted by the movement in currency exchange rates since the first quarter of fiscal 2016 periods, with revenues increasing 15%10% and 12% on a constant-currency basis over the second quarter and first quartersix months of fiscal 2016.2016, respectively. Our Life Science segment continued to benefit from increased sales into China, with such sales totaling approximately $700$1,300 during the firstsecond quarter of fiscal 2017 (approximately $200 in the molecular components business and $500$1,100 in the immunoassay components business). and approximately $2,000 during theyear-to-date period (approximately $400 in the molecular components business and $1,600 in the immunoassay components 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

During the first three months of fiscal 2016, the Company recorded approximately $500 of medical device tax expense, 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 atwo-year moratorium on this excise tax effective January 1, 2016. We are unable to predict any future legislative changes or developments related to this moratorium or excise tax.

Gross Profit

 

  Three Months Ended December 31,   Three Months Ended March 31, Six Months Ended March 31, 
  2016 2015 Change   2017 2016 Change 2017 2016 Change 

Gross Profit

  $29,450  $31,583  (7)%   $33,531  $33,572  —   $62,981  $65,155  (3)% 

Gross Profit Margin

   63 67  -4 points     62 65 -3 points  62 66 -4 points 

The gross profit decreases experienced in fiscal 2017 primarily result from the combined effects of (i) mix of products sold, particularly decreased contribution from our higher marginH. pylori products; (ii) customer mix; (iii) operating segment mix; and (iii)(iv) decreased production levels in certain of our production facilities.

 

Page 1719


Operating Expenses

 

  Three Months Ended December 31, 2016   Three Months Ended March 31, 2017 
  Research &
Development
 Selling &
Marketing
 General &
Administrative
 Total Operating
Expenses
   Research &
Development
 Selling &
Marketing
 General &
Administrative
 Acquisition-
Related Costs
 Total Operating
Expenses
 

2016 Expenses

  $3,381  $6,443  $8,173  $17,997   $3,129  $7,210  $6,875  $1,202  $18,416 
  

 

  

 

  

 

  

 

   

 

  

 

  

 

  

 

  

 

 

% of Revenues

   7 14 17 38   6 14 13 2 36

Fiscal 2017 Increases (Decreases):

     

Fiscal 2017 Increases (Decreases):

 

Diagnostics

   60  942  506  1,508    865  654  842  (1,202 1,159 

Life Science

   (36 129  (233 (140   (87 148  (291  —    (230
  

 

  

 

  

 

  

 

   

 

  

 

  

 

  

 

  

 

 

2017 Expenses

  $3,405  $7,514  $8,446  $19,365   $3,907  $8,012  $7,426  $—    $19,345 
  

 

  

 

  

 

  

 

   

 

  

 

  

 

  

 

  

 

 

% of Revenues

   7 16 18 41   7 15 14 —   36

% Increase

   1 17 3 8

% Increase (Decrease)

   25 11 8 (100)%  5
  Six Months Ended March 31, 2017 
  Research &
Development
 Selling &
Marketing
 General &
Administrative
 Acquisition-
Related Costs
 Total Operating
Expenses
 

2016 Expenses

  $6,510  $13,653  $14,769  $1,481  $36,413 
  

 

  

 

  

 

  

 

  

 

 

% of Revenues

   7 14 15 2 37

Fiscal 2017 Increases (Decreases):

Fiscal 2017 Increases (Decreases):

 

Diagnostics

   925  1,596  1,627  (1,481 2,667 

Life Science

   (123 277  (524  —    (370
  

 

  

 

  

 

  

 

  

 

 

2017 Expenses

  $7,312  $15,526  $15,872  $—    $38,710 
  

 

  

 

  

 

  

 

  

 

 

% of Revenues

   7 15 16 —   38

% Increase (Decrease)

   12 14 7 (100)%  6

Total operating expenses increased during both the second quarter and first quartersix months of fiscal 2017 compared to the first quarter ofcorresponding fiscal 2016. This level2016 periods. These levels of operating expenses resultsresult primarily from the combined effects of (i) the addition of Magellan’s operating expenses totaling $2,800;$2,700 and $5,500 for the quarterly andyear-to-date periods, respectively; (ii) decreased selling, marketing, general and administrative operating expenses in our core diagnostics business, including the effect of revising vacation accrual policies.policies; and (iii) the acquisition-related expenses included within the fiscal 2016 periods. Although research and development expenses of our core diagnostics business were flat on asix-month basis, we expect a modest increase in such spending as we move a number of new products through development.

Operating Income

Operating income decreased 26%6% to $10,085$14,186 for the second quarter of fiscal 2017, and decreased 16% to $24,271 for the first quartersix months of fiscal 2017, as a result of the factors discussed above.

Income Taxes

The effective rate for income taxes was 34% and 35% for both the first quarter of fiscal 2017 second quarter and 2016.six monthyear-to-date periods, respectively. These rates are lower than the 39% and 37% in the comparable fiscal 2016 periods due to thenon-deductibility of certain expenses incurred in connection with fiscal 2016 acquisition activities. For the fiscal year ending September 30, 2017, we expect the effective tax rate to approximate35%-36%.

Page 20


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 consideringFollowing the release of results for the 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 $0.20declared. This action, as well as the declaration of a $0.125 per share cash dividend for the second quarter, serves 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 representing 83%85% of first quarterdiluted earnings per diluted share).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. Our objectives in managing the investment portfolio are to (i) preserve capital; (ii) provide sufficient liquidity to meet working capital requirements and fund strategic objectives such as acquisitions; and (iii) capture a market rate of return commensurate with market conditions and our policy’s investment eligibility criteria. As we look forward, we will continue to manage the holdings of our investment portfolio with preservation of capital being the primary objective.

Page 18


OnFollowing its June 23, 2016 the United Kingdom votedvote to leave the European Union (commonly referred to as “Brexit”) and while, on March 29, 2017, the United Kingdom invoked Article 50 of the Lisbon Treaty; thus formally commencing the process of exiting the European Union. While the impact of Brexit remains uncertain, the resulting immediate changes in foreign currency exchange rates have had a limited overall impact due to natural hedging. However, any 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 possible 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, we do not expect macroeconomic 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 worsen 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 $12,993$25,132 for the first threesix months of fiscal 2017, a 7%36% increase from the $12,092$18,461 provided during the first threesix months of fiscal 2016. While reflecting the timing of payments from customers and to suppliers and taxing authorities, this increase also results in large part from the net effects of (i) decreased inventory levels during the first quarter ofyear-to-date fiscal 2017 period, compared to increased levels during theyear-to-date fiscal 2016 first quarter;period; and (ii) decreased accrued employee compensation costs during the first quartersix months of fiscal 2017, reflecting the payment of discretionary bonuses and the timing of regularly scheduled payroll payments.related to fiscal 2016. 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.

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 $67,874, utilizing the proceeds from a $60,000 five-year term loan and cash and equivalents on hand. An amount of the acquisition consideration totaling $2,383 remains payable to the sellers, pending the realization of tax benefits for certain net operating loss carryforwards in future tax returns.

Page 21


Capital Resources

As 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. As also described in Note 7, exposure to the volatility of the term loan’s variable interest rate is limited by an interest rate swap agreement with the commercial bank. In addition, we have a $30,000 revolving credit facility with a commercial bank that expires March 31, 2021. As of January 31,April 30, 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 threesix months of fiscal 2017 or during the full year of fiscal 2016.

Our capital expenditures are estimated to range between approximately $3,000 to $5,000 for fiscal 2017, with the actual amount dependent 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 undisclosedoff-balance sheet arrangements.

Page 19


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, 2016.

ITEM 4. CONTROLS AND PROCEDURES

As of DecemberMarch 31, 2016,2017, 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 Rule13a-15(b) and15d-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 DecemberMarch 31, 2016.2017. 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 firstsecond 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 DecemberMarch 31, 2016.2017. 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 Form10-K in response to Item 1A to Part I of Form10-K.

ITEM 6. EXHIBITS

The following exhibits are being filed or furnished as a part of this Quarterly Report on Form10-Q.

 

  31.1  Certification of Principal Executive Officer Pursuant to Securities Exchange Act Rule13a-14(a)/15d-14(a)
  31.2  Certification of Principal Financial Officer Pursuant to Securities Exchange Act Rule13a-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 Form10-Q for the quarter ended DecemberMarch 31, 20162017 filed with the SEC on February 9,May 10, 2017, formatted in XBRL includes: (i) Condensed Consolidated Statements of Operations for the three and six months ended DecemberMarch 31, 20162017 and 2015;2016; (ii) Condensed Consolidated Statements of Comprehensive Income for the three and six months ended DecemberMarch 31, 20162017 and 2015;2016; (iii) Condensed Consolidated Statements of Cash Flows for the threesix months ended DecemberMarch 31, 20162017 and 2015;2016; (iv) Condensed Consolidated Balance Sheets as of DecemberMarch 31, 20162017 and September 30, 2016; (v) Condensed Consolidated Statement of Shareholders’ Equity for the threesix months ended DecemberMarch 31, 2016;2017; 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:February 9,May 10, 2017 By:   

/s/ Melissa A. Lueke

  Melissa A. Lueke
  

Executive Vice President and Chief Financial Officer

(Principal Financial and Accounting Officer)

 

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