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 December 31, 2016June 30, 2017

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 JanuaryJuly 31, 2017

Common Stock, no par value 42,202,39742,203,017


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 December 31,June 30, 2017 and 2016 and 2015

   1 
  

Condensed Consolidated Statements of Comprehensive Income Three and Nine Months Ended December 31,June 30, 2017 and 2016 and 2015

   2 
  

Condensed Consolidated Statements of Cash Flows ThreeNine Months Ended December 31,June 30, 2017 and 2016 and 2015

   3 
  

Condensed Consolidated Balance Sheets December 31, 2016June  30, 2017 and September 30, 2016

   4-5 
  

Condensed Consolidated Statement of Changes in Shareholders’ Equity ThreeNine Months Ended December 31, 2016June 30, 2017

   6 
  

Notes to Condensed Consolidated Financial Statements

   7-127-14 

Item 2.

  

Management’s Discussion and Analysis of Financial Condition and Results of Operations

   13-1915-24 

Item 3.

  

Quantitative and Qualitative Disclosures About Market Risk

   2025 

Item 4.

  

Controls and Procedures

   2025 
PART II.  OTHER INFORMATION
Item 1A.Risk Factors   20 

Item 6.1A.

  

ExhibitsRisk Factors

   2025 

Item 6.

Exhibits

25

Signature

     2126 

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 operating results, financial condition and 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 outcome of goodwill impairment testing and the impact of possible goodwill impairments on Meridian’s earnings and financial results. 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 Nine Months Ended 
  Three Months Ended
December 31,
   June 30, June 30, 
  2016 2015   2017 2016 2017 2016 

NET REVENUES

  $46,809  $47,160   $50,140  $50,665  $151,074  $149,084 

COST OF SALES

   17,359  15,577    18,943  17,756  56,896  51,020 
  

 

  

 

   

 

  

 

  

 

  

 

 

GROSS PROFIT

   29,450  31,583    31,197  32,909  94,178  98,064 
  

 

  

 

   

 

  

 

  

 

  

 

 

OPERATING EXPENSES

        

Research and development

   3,405  3,381    3,906  3,546  11,218  10,056 

Selling and marketing

   7,514  6,443    7,885  8,085  23,411  21,738 

General and administrative

   8,446  8,173    8,474  7,537  24,346  22,306 

Goodwill impairment charge

   6,628   —    6,628   —   

Acquisition-related costs

   —     —     —    1,481 
  

 

  

 

   

 

  

 

  

 

  

 

 

Total operating expenses

   19,365  17,997    26,893  19,168  65,603  55,581 
  

 

  

 

   

 

  

 

  

 

  

 

 

OPERATING INCOME

   10,085  13,586    4,304  13,741  28,575  42,483 

OTHER INCOME (EXPENSE)

        

Interest income

   22  17    51  22  102  42 

Interest expense

   (423  —      (407 (427 (1,238 (470

Other, net

   (25 96    (2 65  356  (163
  

 

  

 

   

 

  

 

  

 

  

 

 

Total other income (expense)

   (426 113 

Total other expense

   (358 (340 (780 (591
  

 

  

 

   

 

  

 

  

 

  

 

 

EARNINGS BEFORE INCOME TAXES

   9,659  13,699    3,946  13,401  27,795  41,892 

INCOME TAX PROVISION

   3,380  4,806    3,706  4,647  11,964  15,154 
  

 

  

 

   

 

  

 

  

 

  

 

 

NET EARNINGS

  $6,279  $8,893   $240  $8,754  $15,831  $26,738 
  

 

  

 

   

 

  

 

  

 

  

 

 

BASIC EARNINGS PER COMMON SHARE

  $0.15  $0.21   $0.01  $0.21  $0.38  $0.64 

DILUTED EARNINGS PER COMMON SHARE

  $0.15  $0.21   $0.01  $0.21  $0.37  $0.63 

WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING - BASIC

   42,159  41,947    42,203  42,076  42,184  42,000 

EFFECT OF DILUTIVE STOCK OPTIONS AND RESTRICTED SHARE UNITS

   376  380    390  387  372  379 
  

 

  

 

   

 

  

 

  

 

  

 

 

WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING - DILUTED

   42,535  42,327    42,593  42,463  42,556  42,379 
  

 

  

 

   

 

  

 

  

 

  

 

 

ANTI-DILUTIVE SECURITIES:

        

Common share options and restricted share units

   715  450    861  465  872  449 
  

 

  

 

   

 

  

 

  

 

  

 

 

DIVIDENDS DECLARED PER COMMON SHARE

  $0.20  $0.20   $0.125  $0.20  $0.45  $0.60 
  

 

  

 

   

 

  

 

  

 

  

 

 

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

 

Page 1


MERIDIAN BIOSCIENCE, INC. AND SUBSIDIARIES

Condensed Consolidated Statements of Comprehensive Income (Unaudited)

(in thousands)

 

  Three Months Ended
December 31,
   Three Months Ended
June 30,
 Nine Months Ended
June 30,
 
  2016 2015   2017 2016 2017 2016 

NET EARNINGS

  $6,279  $8,893   $240  $8,754  $15,831  $26,738 

Other comprehensive income (loss):

        

Foreign currency translation adjustment

   (1,423 (787   1,363  (1,563 452  (2,479

Unrealized gain on cash flow hedge

   1,560   —   

Unrealized gain (loss) on cash flow hedge

   (164 (417 1,524  (1,111

Income taxes related to items of other comprehensive income

   (589  —      39  228  (574 522 
  

 

  

 

   

 

  

 

  

 

  

 

 

Other comprehensive income (loss), net of tax

   (452 (787   1,238  (1,752 1,402  (3,068
  

 

  

 

   

 

  

 

  

 

  

 

 

COMPREHENSIVE INCOME

  $5,827  $8,106   $1,478  $7,002  $17,233  $23,670 
  

 

  

 

   

 

  

 

  

 

  

 

 

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 

Nine Months Ended June 30,

  2017 2016 

CASH FLOWS FROM OPERATING ACTIVITIES

      

Net earnings

  $6,279  $8,893   $15,831  $26,738 

Non-cash items included in net earnings:

      

Depreciation of property, plant and equipment

   1,078  896    3,255  2,871 

Amortization of intangible assets

   968  388    2,843  1,834 

Amortization of deferred instrument costs

   257  281    745  829 

Stock-based compensation

   1,884  1,611    2,891  2,654 

Goodwill impairment charge

   6,628   —   

Deferred income taxes

   2,091  433    1,010  (753

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

   5,764  (9,556

Change in current liabilities, net of acquisition

   (5,549 868 

Other, net

   (311 (58   (927 (140
  

 

  

 

   

 

  

 

 

Net cash provided by operating activities

   12,993  12,092    32,491  26,004 
  

 

  

 

   

 

  

 

 

CASH FLOWS FROM INVESTING ACTIVITIES

      

Purchase of property, plant and equipment

   (1,392 (776   (3,402 (2,688

Purchase of equity method investment

   —    (600   —    (600

Purchase of intangibles and other assets

   —    (16

Acquisition of Magellan, net of cash acquired

   —    (62,090
  

 

  

 

   

 

  

 

 

Net cash used for investing activities

   (1,392 (1,392   (3,402 (65,378
  

 

  

 

   

 

  

 

 

CASH FLOWS FROM FINANCING ACTIVITIES

      

Dividends paid

   (8,440 (8,407   (18,990 (25,233

Payment on term loan

   (750  —   

Proceeds from term loan, net of issuance costs

   —    59,851 

Payments on term loan

   (2,625 (750

Proceeds and tax benefits from exercises of stock options

   301  1,470    303  2,033 
  

 

  

 

   

 

  

 

 

Net cash used for financing activities

   (8,889 (6,937

Net cash (used for) provided by financing activities

   (21,312 35,901 
  

 

  

 

   

 

  

 

 

Effect of Exchange Rate Changes on Cash and Equivalents

   (662 (314   250  (697
  

 

  

 

   

 

  

 

 

Net Increase in Cash and Equivalents

   2,050  3,449 

Net Increase (Decrease) in Cash and Equivalents

   8,027  (4,170

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   $55,253  $45,803 
  

 

  

 

   

 

  

 

 

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

 

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

(Unaudited)
   September 30,
2016
 

CURRENT ASSETS

        

Cash and equivalents

  $49,276   $47,226   $55,253   $47,226 

Accounts receivable, less allowances of $346 and $334

   24,278    27,102 

Accounts receivable, less allowances of $384 and $334

   27,731    27,102 

Inventories

   44,709    45,057    40,927    45,057 

Prepaid expenses and other current assets

   7,785    7,406    5,256    7,406 
  

 

   

 

   

 

   

 

 

Total current assets

   126,048    126,791    129,167    126,791 
  

 

   

 

   

 

   

 

 

PROPERTY, PLANT AND EQUIPMENT, at Cost

        

Land

   1,147    1,155    1,157    1,155 

Buildings and improvements

   31,595    31,487    31,877    31,487 

Machinery, equipment and furniture

   45,712    45,085    47,566    45,085 

Construction in progress

   1,953    1,947    2,005    1,947 
  

 

   

 

   

 

   

 

 

Subtotal

   80,407    79,674    82,605    79,674 

Less: accumulated depreciation and amortization

   49,975    49,224    52,440    49,224 
  

 

   

 

   

 

   

 

 

Net property, plant and equipment

   30,432    30,450    30,165    30,450 
  

 

   

 

   

 

   

 

 

OTHER ASSETS

        

Goodwill

   60,705    61,982    54,612    61,982 

Other intangible assets, net

   29,348    29,855    27,592    29,855 

Restricted cash

   1,000    1,000    1,000    1,000 

Deferred instrument costs, net

   1,339    1,392    1,406    1,392 

Fair value of interest rate swap

   831    —      795    —   

Other assets

   352    353    406    353 
  

 

   

 

   

 

   

 

 

Total other assets

   93,575    94,582    85,811    94,582 
  

 

   

 

   

 

   

 

 

TOTAL ASSETS

  $250,055   $251,823   $245,143   $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
   June 30,
2017
(Unaudited)
 September 30,
2016
 

CURRENT LIABILITIES

      

Accounts payable

  $7,511  $7,627   $5,909  $7,627 

Accrued employee compensation costs

   5,064  7,106    3,287  7,106 

Current portion of acquisition consideration

   2,383   —   

Other accrued expenses

   2,833  2,606    2,398  2,606 

Current portion of long-term debt

   4,125  3,750    4,500  3,750 

Income taxes payable

   1,511  1,482    1,502  1,482 
  

 

  

 

   

 

  

 

 

Total current liabilities

   21,044  22,571    19,979  22,571 
  

 

  

 

   

 

  

 

 

NON-CURRENT LIABILITIES

      

Acquisition consideration

   2,383  2,383    —    2,383 

Non-current compensation liabilities

   2,458  2,305 

Post-employment benefits

   2,472  2,305 

Fair value of interest rate swap

   —    729    —    729 

Long-term debt

   53,495  54,610    51,263  54,610 

Deferred income taxes

   4,943  2,753    3,880  2,753 
  

 

  

 

   

 

  

 

 

Total non-current liabilities

   63,279  62,780    57,615  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, 42,202,807 and 42,106,587 shares issued, respectively

   —     —   

Additional paid-in capital

   124,229  122,356    125,190  122,356 

Retained earnings

   47,471  49,632    46,473  49,632 

Accumulated other comprehensive loss

   (5,968 (5,516   (4,114 (5,516
  

 

  

 

   

 

  

 

 

Total shareholders’ equity

   165,732  166,472    167,549  166,472 
  

 

  

 

   

 

  

 

 

TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY

  $250,055  $251,823   $245,143  $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   —      —    (18,990  —    (18,990

Exercise of stock options

   18    (11  —     —    (11   18    (57  —     —    (57

Conversion of restricted share units

   77    —     —     —     —      78    —     —     —     —   

Stock compensation expense

   —      1,884   —     —    1,884    —      2,891   —     —    2,891 

Net earnings

   —      —    6,279   —    6,279    —      —    15,831   —    15,831 

Foreign currency translation adjustment

   —      —     —    (1,423 (1,423   —      —     —    452  452 

Hedging activity, net of tax

   —      —     —    971  971    —      —     —    950  950 
  

 

   

 

  

 

  

 

  

 

   

 

   

 

  

 

  

 

  

 

 

Balance at December 31, 2016

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

Balance at June 30, 2017

   42,203   $125,190  $46,473  $(4,114 $167,549 
  

 

   

 

  

 

  

 

  

 

   

 

   

 

  

 

  

 

  

 

 

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 December 31, 2016,June 30, 2017, the results of its operations for the three and nine month periods ended December 31,June 30, 2017 and 2016, and 2015, and its cash flows for the threenine month periods ended December 31, 2016June 30, 2017 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). WhileThe Company has prepared an inventory of its existing revenue streams and a preliminary analysis of the revenue recognition criteria applying ASU2014-09. This analysis is preliminary and our overall assessment is not yet complete. However, based on the analysis completed to date, the Company has begun the process of identifying, categorizing and analyzing its various revenue streams, the Company hasdoes not yet completed its assessment of the impactcurrently anticipate that adoption of this guidanceASU2014-09 will have a material impact on its financial statements.

In February 2016, the FASB issued ASUNo. 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 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 ASUNo. 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 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. Upon adoption of this guidance, these tax effects will be required to be recorded directly to income tax expense and reflected within the operating

Page 7


activities section of the statement of cash flows. While the impact of this guidance, which the Company plans to adopt on a prospective 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 ASUNo. 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 significantmaterial impact on the Company’s statement of cash flows.

Page 7


In October 2016, the FASB issued ASUNo. 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 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 significantmaterial impact on the Company’s consolidated results of operations, cash flows or financial position.

Issued but not yet effective accounting pronouncements are not expectedIn January 2017, the FASB issued ASUNo. 2017-04,Simplifying the Test for Goodwill Impairment, which serves to havesimplify the process of testing for goodwill impairment by eliminating the “Step 2” comparison of a material impact onreporting 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 Condensed Consolidated Financial Statements.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. The Company early adopted this guidance during the third quarter of fiscal 2017, as permitted. See Note 6 for discussion of Magellan’s goodwill impairment.

 

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, whichreturns. Of this amount, a payment of approximately $650 is included within non-current liabilities onexpected to be made to the sellers during the fourth quarter of fiscal 2017. The remaining amount is expected to be paid in 2018 upon filing of our Condensed Consolidated Balance Sheet.U.S. tax 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 originally recorded in connection with this acquisition, none of which will beis deductible for tax purposes. As of June 30, 2017, the goodwill recorded in connection with the acquisition has been written down to $33,963 (see Note 6 for a discussion of the $6,628 impairment write-down). 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 Statement of Operations for the nine months ended June 30, 2016 includes $1,105 of transaction costs related to the Magellan acquisition, which are reflected as Operating Expenses.

Page 8


The Magellan results of operations, which are included in ourthe accompanying Condensed Consolidated StatementStatements of Operations for the three months ended December 31, 2016 and reported as part of the Diagnostics operating segment, include $726include:

(i)$154 of cost of sales for both the three and nine months ended June 30, 2016 related to theroll-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 ($0 in the fiscal 2017 periods); and

(ii)$675 and $2,062 of general and administrative expenses for the three and nine months ended June 30, 2017, respectively, related to the amortization of specific identifiable intangible assets recorded on the opening balance sheet including customer relationships, technology,non-compete agreements and trade names. Such expenses totaled $746 for both the three and nine months ended June 30, 2016.

The results of general and administrative expenses related toMagellan included in 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 December 31,June 30, 2017 and 2016 include net revenues and net earnings from Magellan totaling $5,199 and $468, respectively, and reflectare as follows, reflecting the items noted above, including the $6,628 goodwill impairment charge, and excludeexcluding interest expense on the debt secured by Meridian in connection with the transaction.

transaction:

 

Page 8


   

Three Months

Ended June 30,

   

Nine Months

Ended June 30,

 
   2017   2016   2017   2016 

Net Revenues

  $4,330   $4,752   $13,174   $4,752 

Net Earnings

  $(6,316  $231   $(6,128  $231 

The recognized preliminary amounts of identifiable assets acquired and liabilities assumed in the acquisition of Magellan arewere 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   Nine Months 
  Three Months Ended
December 31,
   Ended June 30,   Ended June 30, 
  2016   2015   2017   2016   2017   2016 

Net Revenues

  $46,809   $51,095   $50,140   $50,665   $151,074   $156,722 

Net Earnings

  $6,279   $8,517   $240   $8,827   $15,831   $26,891 

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 the nine months ended June 30, 2016);

(ii)reflect the additionaladjustments to depreciation and amortization expense to reflect the amount that would have been charged in connection with the preliminary fair value adjustments to inventory, property, plant and equipment, and identifiable intangible assets ($86972 decrease in expense and $1,149 increase in expense in the quarterthree and nine months ended December 31, 2015)June 30, 2016, respectively);

 

 (ii)(iii)reflect adjustments to stock compensation expense related to 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 ($110(increases in expense of $6 and $95 in the quarterthree and nine months ended December 31, 2015)June 30, 2016, respectively); and

 

 (iii)(iv)reflect theadjustments to interest expense that would have been incurred on the Company’s $60,000 term note ($42952 decrease in expense and $800 increase in expense in the quarterthree and nine months ended December 31, 2015)June 30, 2016, respectively).

 

Page 9


4.Cash and Equivalents

Cash and equivalents include the following components:

 

  December 31, 2016   September 30, 2016   June 30, 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   $—     $6,369   $—     $9,988   $—   

Institutional money market funds

   10,006    —      10,020    —      20,059    —      10,020    —   

Cash on hand -

                

Restricted

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

Unrestricted

   23,642    —      27,218    —      28,825    —      27,218    —   
  

 

   

 

   

 

   

 

   

 

   

 

   

 

   

 

 

Total

  $49,276   $1,000   $47,226   $1,000   $55,253   $1,000   $47,226   $1,000 
  

 

   

 

   

 

   

 

   

 

   

 

   

 

   

 

 

 

Page 10


5.Inventories

Inventories are comprised of the following:

 

  June 30,
2017
   September 30,
2016
 
  December 31,
2016
   September 30,
2016
    

Raw materials

  $7,642   $7,639   $7,212   $7,639 

Work-in-process

   13,535    13,146    11,905    13,146 

Finished goods - instruments

   2,113    2,378    1,566    2,378 

Finished goods - kits and reagents

   21,419    21,894    20,244    21,894 
  

 

   

 

   

 

   

 

 

Total

  $44,709   $45,057   $40,927   $45,057 
  

 

   

 

   

 

   

 

 

 

6.Intangible Assets

Goodwill is subject to an annual impairment review (or more frequently if impairment indicators arise) at the reporting unit level, which we perform annually as of June 30, the end of our third fiscal quarter. During the quarter ended June 30, 2017, the events described below occurred in connection with the Magellan reporting unit, indicating that impairment of the goodwill recorded as part of the acquisition of Magellan had occurred.

On May 17, 2017, the FDA issued a field safety notice advising customers to discontinue use of Magellan’s lead testing systems with venous blood samples. This was followed by product recall notices on May 25th and June 5th. Magellan’s lead testing systems are capable of processing both capillary and venous blood samples. Magellan’s LeadCare Plus and LeadCare Ultra systems, which account for approximately 10% of Magellan’s annual revenues, are used predominantly with venous blood samples. Magellan’s LeadCare and LeadCare II systems are predominantly used with capillary blood samples. Since issuance of the field safety and recall notices, the FDA has completed a quality system inspection of Magellan and has issued its Form FDA 483 to Magellan. As a result of one of the observations contained within the Form FDA 483 involving a Medical Device Report, we expect that the FDA will issue a Warning Letter requiring periodic reporting on our remediation progress. Upon evaluation of the Form FDA 483 and potential Warning Letter, we believe we may experience further delays in reinstating venous blood sample testing on our LeadCare products, as well as in obtaining 510(k) clearance for new Magellan products. Additionally, we may also experience delays in obtaining export certifications for Magellan products during the remediation period.

In light of these factors and their impacts, it was determined that a potential impairment of goodwill recorded in connection with the acquisition of Magellan had occurred (i.e., a “triggering event”). With the assistance of an independent valuation firm, Magellan’s fair value was calculated via both market (comparable company) and income (discounted cash flows) approaches. Based upon these approaches, it was determined that the carrying value of the Magellan reporting unit did, in fact, exceed its fair value. As a result, an impairment charge of $6,628, on both apre-tax andafter-tax basis, has been recorded during the third quarter and is reflected as a separate operating expense line item within the accompanying Condensed Consolidated Statements of Operations for the three and nine months ended June 30, 2017.

Page 11


A summary of our acquired intangible assets subject to amortization, as of December 31, 2016June 30, 2017 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


   June 30, 2017   September 30, 2016 
   Gross
Carrying
Value
   Accumulated
Amortization
   Gross
Carrying
Value
   Accumulated
Amortization
 

Manufacturing technologies, core products and cell lines

  $22,294   $12,466   $21,921   $11,540 

Trade names, licenses and patents

   8,643    4,139    9,037    3,947 

Customer lists, customer relationships and supply agreements

   24,457    11,467    24,385    10,511 

Non-compete agreements

   720    450    680    170 
  

 

 

   

 

 

   

 

 

   

 

 

 
  $56,114   $28,522   $56,023   $26,168 
  

 

 

   

 

 

   

 

 

   

 

 

 

The actual aggregate amortization expense for these intangible assets was $968$939 and $388$1,072 for the three months ended December 31,June 30, 2017 and 2016, respectively, and 2015,$2,843 and $1,834 for the nine months ended June 30, 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,$937, fiscal 2018 – $3,524,$3,547, fiscal 2019 – $3,303,$3,326, fiscal 2020 – $3,144,$3,164, 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,$1,125, 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 December 31, 2016June 30, 2017 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; (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 December 31, 2016,June 30, 2017, the fair value of the interest rate swap was an asset of $831,$795, 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 December 31, 2016June 30, 2017 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,June 30, 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.

 

Page 12


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% and 16% of consolidated accounts receivable at December 31, 2016June 30, 2017 and September 30, 2016, respectively. Revenues from these two distributor customers accounted for 23%29% and 39%25% of the Diagnostics segment third-party revenues during the three months ended December 31,June 30, 2017 and 2016, and 2015, respectively, and 29% and 30% during the nine months ended June 30, 2017 and 2016, respectively. These distributors represented 17%21% and 29%19% of consolidated revenues for the fiscal 2017 and 2016 firstthird quarters, respectively.respectively, and 20% and 22% for the respectiveyear-to-date nine month periods.

Within our Life Science segment, two diagnostic manufacturing customers accounted for 19%10% and 18%23% of the segment’s third-party revenues during the three months ended December 31,June 30, 2017 and 2016, respectively, and 2015,17% and 20% during the nine months ended June 30, 2017 and 2016, respectively.

Page 13


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 June 30, 2017

Three Months Ended June 30, 2017

 

Net revenues -

                

Third-party

  $33,808   $13,001   $—     $46,809   $35,949   $14,191   $—     $50,140 

Inter-segment

   79    125    (204   —      71    129    (200   —   

Operating income

   6,643    3,267    175    10,085 

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

        

Operating income (2)

   914    3,388    2    4,304 

Goodwill (June 30, 2017)

   35,213    19,399    —      54,612 

Other intangible assets, net (June 30, 2017)

   25,745    1,847    —      27,592 

Total assets (June 30, 2017)

   177,789    67,294    60    245,143 

Three Months Ended June 30, 2016

Three Months Ended June 30, 2016

 

Net revenues -

                

Third-party

  $35,301   $11,859   $—     $47,160   $37,523   $13,142   $—     $50,665 

Inter-segment

   71    367    (438   —      70    201    (271   —   

Operating income

   10,330    3,236    20    13,586    9,886    3,696    159    13,741 

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 

Nine Months Ended June 30, 2017

Nine Months Ended June 30, 2017

 

Net revenues -

        

Third-party

  $107,529   $43,545   $—     $151,074 

Inter-segment

   278    361    (639   —   

Operating income (2)

   17,152    11,226    197    28,575 

Nine Months Ended June 30, 2016

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 

 

(1)Eliminations consist of inter-segment transactions.
(2)Diagnostics’ operating income includes effect of the Magellan goodwill impairment charge in the amount of $6,628 during the three and nine month periods ended June 30, 2017.

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

 

Page 1214


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 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 U.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 on 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 the downward revision to our fiscal 2017 revenue and earnings guidance, and 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.

Three Months Ended December 31, 2016June 30, 2017

Net earnings for the firstthird quarter of fiscal 2017 decreased 29%97% to $6,279,$240, or $0.15$0.01 per diluted share, from net earnings for the firstthird quarter of fiscal 2016 of $8,893,$8,754, or $0.21 per diluted share. The fiscal 2017 results include an impairment charge against Magellan goodwill ($6,628 or $0.16 per diluted share). Net earnings for the third quarter of fiscal 2017 also include increased legal and professional services spending. These expenses totaled approximately $500 after income taxes, or $0.01 per diluted share. Consolidated revenues decreased 1% to $46,809$50,140 for the firstthird quarter of fiscal 2017 compared to the same period of the prior year (flat on a constant-currency basis).

Revenues for the Diagnostics segment for the firstthird quarter of fiscal 2017 decreased 4% compared to the firstthird quarter of fiscal 2016 (also down 4% on a constant-currency basis), comprised of a 22%20% decrease in molecular products and a 2% increase innon-molecular products, including $5,199 of Magellan revenues. products. With an 11%a 7% increase in its immunoassay components business and an 8%a 10% increase in its molecular components business, revenues of our Life Science segment increased by 10%8% during the firstthird quarter of fiscal 2017 compared to the firstthird quarter of fiscal 2016 increasing 12%(increasing 10% on a constant-currency basis.basis).

Nine Months Ended June 30, 2017

For the nine month period ended June 30, 2017, net earnings decreased 41% to $15,831, or $0.37 per diluted share, compared to net earnings for the comparable fiscal 2016 period of $26,738, or $0.63 per diluted share. Theyear-to-date fiscal 2017 results include an impairment charge against Magellan goodwill ($6,628 or $0.16 per diluted share), andyear-to-date fiscal 2016 results include 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 1% to $151,074 for the first nine months of fiscal 2017 compared to the same period of the prior year (increasing 2% on a constant-currency basis).

Revenues for the Diagnostics segment for the first nine months of fiscal 2017 decreased 2% compared to the first nine months of fiscal 2016 (also 2% on a constant-currency basis), comprised of a 15% decrease in molecular products and a 2% increase innon-molecular products, including an $8,422 increase in Magellan revenues resulting from only three months of Meridian ownership during the comparable fiscal 2016 period. With a 15% increase in its immunoassay components business and a 7% increase in its molecular components business, revenues of our Life Science segment increased by 12% during the first nine months of fiscal 2017 compared to the first nine months of fiscal 2016 (increasing 14% on a constant-currency basis).

 

Page 1315


Magellan FDA Activities and Goodwill Impairment Charge

On May 17, 2017, the FDA issued a field safety notice advising customers to discontinue use of Magellan’s lead testing systems with venous blood samples. This was followed by product recall notices on May 25th and June 5th. Magellan’s lead testing systems are capable of processing both capillary and venous blood samples. Magellan’s LeadCare Plus and LeadCare Ultra systems, which account for approximately 10% of Magellan’s annual revenues, are used predominantly with venous blood samples. Magellan’s LeadCare and LeadCare II systems are predominantly used with capillary blood samples. Since issuance of the field safety and recall notices, the FDA has completed a quality system inspection of Magellan and has issued its Form FDA 483 to Magellan. As a result of one of the observations contained within the Form FDA 483 involving a Medical Device Report, we expect that the FDA will issue a Warning Letter requiring periodic reporting on our remediation progress. Upon evaluation of the Form FDA 483 and potential Warning Letter, we believe we may experience further delays in reinstating venous blood sample testing on our LeadCare products, as well as in obtaining 510(k) clearance for new Magellan products. Additionally, we may also experience delays in obtaining export certifications for Magellan products during the remediation period.

In light of these factors and their impacts, it was determined that a potential impairment of goodwill recorded in connection with the acquisition of Magellan had occurred (i.e., a “triggering event”). With the assistance of an independent valuation firm, Magellan’s fair value was calculated via both market (comparable company) and income (discounted cash flows) approaches. Based upon these approaches, it was determined that the carrying value of the Magellan reporting unit did, in fact, exceed its fair value. As a result, an impairment charge of $6,628, on both apre-tax andafter-tax basis, has been recorded during the third quarter and is reflected as a separate operating expense line item within the accompanying Condensed Consolidated Statements of Operations for the three and nine months ended June 30, 2017. Given all of the factors considered, we do not anticipate, at this time, any further goodwill impairment charge from the Magellan acquisition.

This impairment charge does not impact our cash flow, our dividend or our bank covenants. Our outlook for Magellan’s LeadCare II testing volume continues to be healthy. In the 60+ days since the FDA released its Safety Notification (which pertained to venous blood lead testing performed on the systems produced by Magellan), 176 new LeadCare II systems utilizing capillary blood samples have been placed in physician offices and clinics. For the nine months ended June 30, 2017, LeadCare II placements have increased 11% over the prior year comparable period. These placements and ongoing placements of LeadCare IIpoint-of-care systems and related capillary blood testing are expected to drive revenue growth in 2018 and beyond.

The matters connected with the FDA Safety Notification occurred at Magellan prior to Meridian’s acquisition of Magellan. Meridian is committed to working diligently to strengthen Magellan’s quality system and to address the observations noted in the Form FDA 483 with the highest sense of urgency. However, we can provide no assurance that our remediation efforts will be successful to a degree acceptable by the FDA within our contemplated time frame. It should be noted that the FDA has stated that all LeadCare blood lead testing systems can be used with capillary blood samples, the predominant sample type used by physicians testing at thepoint-of-care. We believepoint-of-care lead testing is critical to addressing elevated lead levels among children and adults across the globe, as testing at thepoint-of-care improves compliance and facilitates patient education and intervention.

Beyond the impact of the impairment charge, we believe the impact on revenue related to the FDA’s Safety Notification was approximately $200 during the quarter. This represents the impact of reduced venous blood sample testing sales from the May 17th Safety Notice through June 30, 2017. Costs associated with the matter were less than $100, resulting in a total impact of less than $0.01 on diluted earnings per share for the quarter.

Page 16


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 the impairment charge against Magellan goodwill and 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 impacts of the goodwill impairment charge andnon-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.

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.

   Three Months   Nine Months 
   Ended June 30,   Ended June 30, 
   2017   2016   2017   2016 

Net Earnings -

        

U.S. GAAP basis

  $240   $8,754   $15,831   $26,738 

Goodwill impairment charge

   6,628    —      6,628    —   

Acquisition-related costs (1)

   —      —      —      1,233 
  

 

 

   

 

 

   

 

 

   

 

 

 

Adjusted earnings

  $6,868   $8,754   $22,459   $27,971 
  

 

 

   

 

 

   

 

 

   

 

 

 

Net Earnings per Basic Common Share -

        

U.S. GAAP basis

  $0.01   $0.21   $0.38   $0.64 

Goodwill impairment charge

   0.16    —      0.16    —   

Acquisition-related costs (1)

   —      —      —      0.03 
  

 

 

   

 

 

   

 

 

   

 

 

 

Adjusted Basic EPS (2)

  $0.16   $0.21   $0.53   $0.67 
  

 

 

   

 

 

   

 

 

   

 

 

 

Net Earnings per Diluted Common Share -

        

U.S. GAAP basis

  $0.01   $0.21   $0.37   $0.63 

Goodwill impairment charge

   0.16    —      0.16    —   

Acquisition-related costs (1)

   —      —      —      0.03 
  

 

 

   

 

 

   

 

 

   

 

 

 

Adjusted Diluted EPS (3)

  $0.16   $0.21   $0.53   $0.66 
  

 

 

   

 

 

   

 

 

   

 

 

 

(1)These acquisition-related costs are net of income tax effects of $248, which were calculated using the effective tax rates of the jurisdictions in which the costs were incurred.
(2)Net Earnings per Basic Common Share for the three and nine months ended June 30, 2017 do not sum due to rounding.
(3)Net Earnings per Diluted Common Share for the three months ended June 30, 2017 does not sum due to rounding.

Page 17


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, 
   2016  2015  Inc (Dec) 

Diagnostics -

    

Americas

  $27,569  $30,115   (8)% 

EMEA

   5,662   4,649   22

ROW

   577   537   7
  

 

 

  

 

 

  

 

 

 

Total Diagnostics

   33,808   35,301   (4)% 
  

 

 

  

 

 

  

 

 

 

Life Science -

    

Americas

   5,399   5,103   6

EMEA

   4,898   4,536   8

ROW

   2,704   2,220   22
  

 

 

  

 

 

  

 

 

 

Total Life Science

   13,001   11,859   10
  

 

 

  

 

 

  

 

 

 

Consolidated

  $46,809  $47,160   (1)% 
  

 

 

  

 

 

  

 

 

 

% of total revenues -

    

Diagnostics

   72  75 

Life Science

   28  25 
  

 

 

  

 

 

  

Total

   100  100 
  

 

 

  

 

 

  

Ex-Americas

   30  25 
  

 

 

  

 

 

  

Page 14


   Three Months Ended June 30,  Nine Months Ended June 30, 
   2017  2016  Inc (Dec)  2017  2016  Inc (Dec) 

Diagnostics -

       

Americas

  $30,810  $31,885   (3)%  $90,221  $93,864   (4)% 

EMEA

   4,232   4,826   (12)%   14,907   14,357   4

ROW

   907   812   12  2,401   1,957   23
  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

 

Total Diagnostics

   35,949   37,523   (4)%   107,529   110,178   (2)% 
  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

 

Life Science -

       

Americas

   5,550   4,790   16  16,681   16,249   3

EMEA

   4,633   5,977   (22)%   16,253   15,127   7

ROW

   4,008   2,375   69  10,611   7,530   41
  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

 

Total Life Science

   14,191   13,142   8  43,545   38,906   12
  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

 

Consolidated

  $50,140  $50,665   (1)%  $151,074  $149,084   1
  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

 

% of total revenues -

       

Diagnostics

   72  74   71  74 

Life Science

   28  26   29  26 
  

 

 

  

 

 

   

 

 

  

 

 

  

Total

   100  100   100  100 
  

 

 

  

 

 

   

 

 

  

 

 

  

Ex-Americas

   27  28   29  26 
  

 

 

  

 

 

   

 

 

  

 

 

  

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

Page 18


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 June 30, Nine Months Ended June 30, 
  2016 2015 Inc (Dec)   2017 2016 Inc (Dec) 2017 2016 Inc (Dec) 

Diagnostics -

           

Molecular

  $7,711  $9,836  (22)%   $8,006  $10,063  (20)%  $25,194  $29,564  (15)% 

Non-molecular

   26,097  25,465  2   27,943  27,460  2 82,335  80,614  2
  

 

  

 

  

 

   

 

  

 

  

 

  

 

  

 

  

 

 

Total Diagnostics

  $33,808  $35,301  (4)%   $35,949  $37,523  (4)%  $107,529  $110,178  (2)% 
  

 

  

 

  

 

   

 

  

 

  

 

  

 

  

 

  

 

 

Life Science -

           

Molecular components

  $5,116  $4,749  8  $5,541  $5,037  10 $15,996  $14,902  7

Immunoassay components

   7,885  7,110  11   8,650  8,105  7 27,549  24,004  15
  

 

  

 

  

 

   

 

  

 

  

 

  

 

  

 

  

 

 

Total Life Science

  $13,001  $11,859  10  $14,191  $13,142  8 $43,545  $38,906  12
  

 

  

 

  

 

   

 

  

 

  

 

  

 

  

 

  

 

 

% of Diagnostics revenues -

           

Molecular

   23 28    22 27  23 27 

Non-molecular

   77 72    78 73  77 73 
  

 

  

 

    

 

  

 

   

 

  

 

  

Total Diagnostics

   100 100    100 100  100 100 
  

 

  

 

    

 

  

 

   

 

  

 

  

% of Life Science revenues -

           

Molecular components

   39 40    39 38  37 38 

Immunoassay components

   61 60    61 62  63 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%20% to $7,711$8,006 for the firstthird quarter of fiscal 2017 (also 22%20% on a constant-currency basis), and decreased 15% to $25,194 for the nine monthyear-to-date period (also 15% 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 1,600 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 450500 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 15


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 120 accounts in the following commercialized tests:EMEA region for use primarily 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 firstthird quarter of fiscal 2017 we experienced 6%9% growth in all molecular testing categories, other than the hyper-competitiveC. difficile arena.arena and 7% growth during the nine monthyear-to-date period. While this market is competitive, with molecular companies such as Cepheid and Becton Dickinson, and

Page 19


others such as Quidel, Great Basin, Nanosphere,Luminex 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 firstthird quarter of fiscal 2017. These2017 and on a nine monthyear-to-date basis. On a quarterly basis, these results reflect a decrease in Magellan revenue and overall increases in ourH. pyloriand foodborne product lines. Theyear-to-date increase reflects the additioncurrent fiscal year including a full nine months of Magellan’sMagellan 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$4,330 and $13,174 during the third quarter of revenues reflects a 32% increase overfiscal 2017 and the nine monthyear-to-date period, respectively. Compared to the three-month periodand nine-month periods ended DecemberJune 30, 2016, of which the six months ended March 31, 2015, which was2016 were prior to Meridian’s ownership of Magellan.Magellan, these revenues decreased 9% and increased 6%, respectively. The decline in Magellan’s revenues for the third quarter reflected the combined effects of lower revenue from venous blood testing during the quarter, resulting fromFDA-related activities, and favorable acquisition-related matters in the previous year. Also, having been affected by distributor and international order patterns earlier in this fiscal year, Magellan has executed distribution agreements with distributors in China and Kenya that are expected to contribute revenues during fiscal 2018.

During the firstthird quarter of fiscal 2017, revenues from ourH. pylori products decreased 18% (also 18%increased 5% (6% on a constant-currency basis) to $7,156.$8,486. These revenues decreased 7% to $23,367 during the first nine months of fiscal 2017 (6% 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 tohave low single-digit growth forduring the balance of fiscal year 2017. This growth expectation reflects customers working through this inventory and replenishing product, and ourthe Company 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 partneringcombining 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 coming months, as we currently market the onlyFDA-cleared tests to detectH. pylori antigen in stool samples.samples in the U.S. market. 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 16


During the firstthird quarter of fiscal 2017, revenues from our other immunoassay products (includingC. difficile, foodborne and respiratory) decreased 18% (also 18%increased 1% (2% on a constant-currency basis) to $13,615. This decrease$14,617. These revenues decreased 11% to $44,154 during the first nine months of fiscal 2017 (10% on a constant-currency basis). These results primarily fromreflect the effects of continued increased competition and distributor order patterns and the timing of our promotional “stock-and-block” programs in previous periods.patterns.

Page 20


Life Science Products

During the firstthird quarter of fiscal 2017, revenues from our Life Science segment increased 10%8%, with revenues from molecular component sales increasing 8%10% from the comparable fiscal 2016 quarter and revenues from immunoassay component sales increasing 11%7%. For the first nine months of fiscal 2017, revenues from our Life Science segment increased 12%, with revenues from molecular component sales increasing 7% from theyear-to-date fiscal 2016 period and revenues from immunoassay component sales increasing 15%. 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% and 13% on a constant-currency basis over the third quarter and first quarternine months of fiscal 2016.2016, respectively. Our Life Science segment continued to benefit from increased sales into China, with such sales totaling approximately $700$2,000 during the firstthird quarter of fiscal 2017 (approximately $200$300 in the molecular components business and $500$1,700 in the immunoassay components business). and approximately $4,000 during theyear-to-date period (approximately $700 in the molecular components business and $3,300 in the immunoassay components business); representing an approximate 65% increase over the fiscal 2016year-to-date period. New products also contributed to growth, including EPIK™ miRNA Select, JetSeq™, SensiFast™ Lyo-Ready and MIC Personal qPCR Cycler and accessories.SensiFast™Lyo-Ready.

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 June 30, Nine Months Ended June 30, 
  2016 2015 Change   2017 2016 Change 2017 2016 Change 

Gross Profit

  $29,450  $31,583  (7)%   $31,197  $32,909  (5)%  $94,178  $98,064  (4)% 

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;products in theyear-to-date period; (ii) customer mix; (iii) operating segment mix; and (iii)(iv) decreased production levels in certain of our production facilities.facilities designed to reduce inventory levels.

 

Page 1721


Operating Expenses

 

  Three Months Ended June 30, 2017 
  Research &
Development
 Selling &
Marketing
 General &
Administrative
 Goodwill
Impairment Charge
and Acquisition-
Related Costs
 Total Operating
Expenses
 

2016 Expenses

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

 

  

 

  

 

  

 

  

 

 

% of Revenues

   7 16 15 —   38

Fiscal 2017 Increases (Decreases):

Fiscal 2017 Increases (Decreases):

 

Diagnostics

   304  (252 686  6,628  7,366 

Life Science

   56  52  251   —    359 
  

 

  

 

  

 

  

 

  

 

 

2017 Expenses

  $3,906  $7,885  $8,474  $6,628  $26,893 
  

 

  

 

  

 

  

 

  

 

 

% of Revenues

   8 16 17 13 54

% Increase (Decrease)

   10 (2)%  12 NMF  40
  Three Months Ended December 31, 2016   Nine Months Ended June 30, 2017 
  Research &
Development
 Selling &
Marketing
 General &
Administrative
 Total Operating
Expenses
   Research &
Development
 Selling &
Marketing
 General &
Administrative
 Goodwill
Impairment Charge
and Acquisition-
Related Costs
 Total Operating
Expenses
 

2016 Expenses

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

 

  

 

  

 

  

 

   

 

  

 

  

 

  

 

  

 

 

% of Revenues

   7 14 17 38   7 15 15 1 37

Fiscal 2017 Increases (Decreases):

     

Fiscal 2017 Increases (Decreases):

 

Diagnostics

   60  942  506  1,508    1,229  1,344  2,313  5,147  10,033 

Life Science

   (36 129  (233 (140   (67 329  (273  —    (11
  

 

  

 

  

 

  

 

   

 

  

 

  

 

  

 

  

 

 

2017 Expenses

  $3,405  $7,514  $8,446  $19,365   $11,218  $23,411  $24,346  $6,628  $65,603 
  

 

  

 

  

 

  

 

   

 

  

 

  

 

  

 

  

 

 

% of Revenues

   7 16 18 41   7 15 16 4 43

% Increase

   1 17 3 8   12 8 9 348 18

Total operating expenses increased during both the third quarter and first quarternine months of fiscal 2017 compared to the first quarter ofcorresponding fiscal 2016. This level of2016 periods, relating primarily to overall increases in spending in our Diagnostics operating segment, as detailed below.

Quarterly Increase

The quarterly increase in Diagnostics operating expenses resultsresult primarily from the combined effects of (i) the additionfollowing:

Recording of Magellan’s operating expenses totaling $2,800;Magellan goodwill impairment charge;

Increased legal and (ii) decreased operating expenses inprofessional services spending; and

Increased research and development spending by our core diagnostics business, includingbusiness.

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Year-to-Date Increase

Theyear-to-date increase in Diagnostics operating expenses result primarily from the effectcombined effects of revising vacation accrual policies.the following:

Recording of Magellan goodwill impairment charge;

Addition of incremental Magellan operating expenses, due to six additional months of Meridian ownership in the current fiscal year period compared to the prior year period;

Increased legal and professional services spending; and

Acquisition-related expenses included within the fiscal 2016year-to-date period.

Operating Income

Operating income decreased 26%69% to $10,085$4,304 for the third quarter of fiscal 2017, and decreased 33% to $28,575 for the first quarternine months of fiscal 2017, as a result of the factors discussed above.above, including most notably the Magellan goodwill impairment charge.

Income Taxes

The effective rate for income taxes was 94% and 43% for the fiscal 2017 third quarter and nine monthyear-to-date periods, respectively. These rates are higher than the 35% and 36% in the comparable fiscal 2016 periods due primarily to thenon-deductibility of the Magellan goodwill impairment charge. Excluding the effects of the Magellan goodwill impairment charge, the effective tax rate was 35% for both the first quarter of fiscal 2017 third quarter and 2016.nine month year-to-date periods. For the fiscal year ending September 30, 2017, we expect the normalized effective tax rate (i.e., excluding the Magellan goodwill impairment charge) to approximate35%-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 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 each of the second and representing 83%third quarters, serves to bring the annual dividend rate more in line with our long-standing policy of first quarterestablishing a cash dividend payout ratio of between 75% and 85% of diluted 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.

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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

Page 23


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$32,491 for the first threenine months of fiscal 2017, a 7%25% increase from the $12,092$26,004 provided during the first threenine 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 quarternine months of fiscal 2017, reflecting the payment of discretionary bonuses related to fiscal 2016 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.

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. Of this amount, a payment of approximately $650 is expected to be made to the sellers during the fourth quarter of fiscal 2017. The remaining amount is expected to be paid in 2018 upon filing of our U.S. tax returns.

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 JanuaryJuly 31, 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 threenine months of fiscal 2017 or during the full year of fiscal 2016.

Our capital expenditures are estimated to range between approximately $3,000$4,000 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 1924


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 December 31, 2016,June 30, 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 Rule Rules13a-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 December 31, 2016.June 30, 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 firstthird 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 December 31, 2016.June 30, 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.

PART II. OTHER INFORMATION

ITEM 1A. RISK FACTORS

There have been no material changes fromto the risk factors as previously disclosed in the Registrant’s Form 10-K in response toPart I – Item 1A to Part I ofin our Annual Report on 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 December 31, 2016June 30, 2017 filed with the SEC on FebruaryAugust 9, 2017, formatted in XBRL includes: (i) Condensed Consolidated Statements of Operations for the three and nine months ended December 31, 2016June 30, 2017 and 2015;2016; (ii) Condensed Consolidated Statements of Comprehensive Income for the three and nine months ended December 31, 2016June 30, 2017 and 2015;2016; (iii) Condensed Consolidated Statements of Cash Flows for the threenine months ended December 31, 2016June 30, 2017 and 2015;2016; (iv) Condensed Consolidated Balance Sheets as of December 31, 2016June 30, 2017 and September 30, 2016; (v) Condensed Consolidated Statement of Shareholders’ Equity for the threenine months ended December 31, 2016;June 30, 2017; and (vi) the Notes to Condensed Consolidated Financial Statements

 

Page 2025


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:FebruaryAugust 9, 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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