SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

Form10-Q

 

 

 

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

For the Quarterly Period Ended June 30,December 31, 2015

OR

 

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

For the transition period from            to            

Commission file number0-14902

 

 

MERIDIAN BIOSCIENCE, INC.

Incorporated under the laws of Ohio

 

 

31-0888197

(I.R.S. Employer Identification No.)

3471 River Hills Drive

Cincinnati, Ohio 45244

(513)271-3700

Indicate by a check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.     Yes  x    No  ¨

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

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act.

 

Large accelerated filer x  Accelerated filer ¨
Non-accelerated filer ¨  Smaller reporting company ¨

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

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

 

Class

  

Outstanding JulyJanuary 31, 20152016

Common Stock, no par value  41,714,63542,051,142

 

 

 


MERIDIAN BIOSCIENCE, INC. AND SUBSIDIARIES

TABLE OF CONTENTS TO QUARTERLY REPORT ON FORM10-Q

 

 

    Page(s) 
PART I. 

FINANCIAL INFORMATION

  

Item 1.

 

Financial Statements (Unaudited)

  
 

Condensed Consolidated Statements of Operations
Three and Nine Months Ended June 30,December 31, 2015 and 2014

   1  
 

Condensed Consolidated Statements of Comprehensive Income
Three and Nine Months Ended June  30,December 31, 2015 and 2014

   2  
 

Condensed Consolidated Statements of Cash Flows Nine
Three Months Ended June 30,December 31, 2015 and 2014

   3  
 

Condensed Consolidated Balance Sheets June 30,
December 31, 2015 and September 30, 20142015

   4-5  
 

Condensed Consolidated Statement of Changes in Shareholders’ Equity Nine
Three Months Ended June 30,December 31, 2015

   6  
 

Notes to Condensed Consolidated Financial Statements

   7-127-10  

Item 2.

 

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

   12-2010-17  

Item 3.

 

Quantitative and Qualitative Disclosures About Market Risk

   2117  

Item 4.

 

Controls and Procedures

   2117  

PART II.

 

OTHER INFORMATION

  

Item 1A.

 

Risk Factors

   2118  

Item 6.

 

Exhibits

   2218  

Signature

   2319  


FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q contains forward-looking statements. The Private Securities Litigation Reform Act of 1995 provides a safe harbor from civil litigation for forward-looking statements accompanied by meaningful cautionary statements. Except for historical information, this report contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, which may be identified by words such as “estimates”, “anticipates”, “projects”, “plans”, “seeks”, “may”, “will”, “expects”, “intends”, “believes”, “should” and similar expressions or the negative versions thereof and which also may be identified by their context. All statements that address operating performance or events or developments that Meridian expects or anticipates will occur in the future, including, but not limited to, statements relating to per share diluted earnings and revenue, are forward-looking statements. Such statements, whether expressed or implied, are based upon current expectations of the Company and speak only as of the date made. Specifically, Meridian’s forward-looking statements are, and will be, based on management’s then-current views and assumptions regarding future events and operating performance. Meridian assumes no obligation to publicly update or revise any forward-looking statements even if experience or future changes make it clear that any projected results expressed or implied therein will not be realized. These statements are subject to various risks, uncertainties and other factors that could cause actual results to differ materially, including, without limitation, the following: Meridian’s continued growth depends, in part, on its ability to introduce into the marketplace enhancements of existing products or new products that incorporate technological advances, meet customer requirements and respond to products developed by Meridian’s competition, and its ability to effectively sell such products. While Meridian has introduced a number of internally developed products, there can be no assurance that it will be successful in the future in introducing such products on a timely basis. Meridian relies on proprietary, patented and licensed technologies, and the Company’s ability to protect its intellectual property rights, as well as the potential for intellectual property litigation, would impact its results. Ongoing consolidations of reference laboratories and formation of multi-hospital alliances may cause adverse changes to pricing and distribution. Recessionary pressures on the economy and the markets in which our customers operate, as well as adverse trends in buying patterns from customers can change expected results. Costs and difficulties in complying with laws and regulations, including those administered by the United States Food and Drug Administration, can result in


unanticipated expenses and delays and interruptions to the sale of new and existing products. The international scope of Meridian’s operations, including changes in the relative strength or weakness of the U.S. dollar and general economic conditions in foreign countries, can impact results and make them difficult to predict. One of Meridian’s growth strategies is the acquisition of companies and product lines. There can be no assurance that additional acquisitions will be consummated or that, if consummated, will be successful and the acquired businesses will be successfully integrated into Meridian’s operations. There may be risks that acquisitions may disrupt operations and may pose potential difficulties in employee retention and there may be additional risks with respect to Meridian’s ability to recognize the benefits of acquisitions, including potential synergies and cost savings or the failure of acquisitions to achieve their plans and objectives. Meridian cannot predict the possible impact of U.S. health care legislation enacted in 2010 – the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act – and any modification or repeal of any of the provisions thereof, and any similar initiatives in other countries on its results of operations. Efforts to reduce the U.S. federal deficit, breaches of Meridian’s information technology systems and natural disasters and other events could have a materially adverse effect on Meridian’s results of operations and revenues. In addition to the factors described in this paragraph, Part I, Item 1A Risk Factors of our Form 10-K contains a list and description of uncertainties, risks and other matters that may affect the Company.


PART I. FINANCIAL INFORMATION

Item 1. Financial Statements

MERIDIAN BIOSCIENCE, INC. AND SUBSIDIARIES

Condensed Consolidated Statements of Operations (Unaudited)

(in thousands, except per share data)

 

  Three Months Ended 
  Three Months Ended
June 30,
 Nine Months Ended
June 30,
   December 31, 
  2015 2014 2015 2014   2015   2014 

NET REVENUES

  $48,204  $47,212  $147,762  $142,140   $47,160   $48,013 

COST OF SALES

   17,873  17,970  55,673  53,298    15,577    18,776 
  

 

  

 

  

 

  

 

   

 

   

 

 

GROSS PROFIT

   30,331  29,242  92,089  88,842    31,583    29,237 
  

 

  

 

  

 

  

 

 
  

 

   

 

 

OPERATING EXPENSES

         

Research and development

   3,214  3,146  9,685  9,185    3,381    3,103 

Selling and marketing

   6,184  6,249  18,745  18,787    6,443    6,080 

General and administrative

   6,535  6,715  20,860  20,446    8,173    7,385 
  

 

  

 

  

 

  

 

   

 

   

 

 

Total operating expenses

   15,933  16,110  49,290  48,418    17,997    16,568 
  

 

  

 

  

 

  

 

   

 

   

 

 

OPERATING INCOME

   14,398  13,132  42,799  40,424    13,586    12,669 

OTHER INCOME (EXPENSE)

         

Interest income

   6  5  18  15    17    6 

Other, net

   (99 (257 (892 (505   96    (582
  

 

  

 

  

 

  

 

   

 

   

 

 

Total other income (expense)

   (93 (252 (874 (490   113    (576
  

 

  

 

  

 

  

 

   

 

   

 

 

EARNINGS BEFORE INCOME TAXES

   14,305  12,880  41,925  39,934    13,699    12,093 

INCOME TAX PROVISION

   5,203  4,045  14,852  13,373    4,806    4,192 
  

 

  

 

  

 

  

 

   

 

   

 

 

NET EARNINGS

  $9,102  $8,835  $27,073  $26,561   $8,893   $7,901 
  

 

  

 

  

 

  

 

   

 

   

 

 

BASIC EARNINGS PER COMMON SHARE

  $0.22  $0.21  $0.65  $0.64   $0.21   $0.19 

DILUTED EARNINGS PER COMMON SHARE

  $0.22  $0.21  $0.64  $0.63   $0.21   $0.19 

WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING - BASIC

   41,714  41,478  41,647  41,445 

WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING—BASIC

   41,947    41,607 

EFFECT OF DILUTIVE STOCK OPTIONS AND RESTRICTED SHARES AND UNITS

   379  618  352  669    380    334 
  

 

  

 

  

 

  

 

   

 

   

 

 

WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING - DILUTED

   42,093  42,096  41,999  42,114 
  

 

  

 

  

 

  

 

 

WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING—DILUTED

   42,327    41,941 
  

 

   

 

 

ANTI-DILUTIVE SECURITIES:

         

Common share options and restricted shares and units

   493  337  567  161    450    566 
  

 

  

 

  

 

  

 

   

 

   

 

 

DIVIDENDS DECLARED PER COMMON SHARE

  $0.20  $0.20  $0.60  $0.59   $0.20   $0.20 
  

 

  

 

  

 

  

 

   

 

   

 

 

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

 

Page 1


MERIDIAN BIOSCIENCE, INC. AND SUBSIDIARIES

Condensed Consolidated Statements of Comprehensive Income (Unaudited)

(in thousands)

 

  Three Months
Ended
 
  Three Months Ended
June 30,
   Nine Months Ended
June 30,
   December 31, 
  2015   2014   2015 2014   2015 2014 

NET EARNINGS

  $9,102   $8,835   $27,073  $26,561   $8,893  $7,901 

Foreign currency translation adjustment

   1,357    361    (2,146 1,421    (787 (1,365
  

 

   

 

   

 

  

 

 
  

 

  

 

 

COMPREHENSIVE INCOME

  $10,459   $9,196   $24,927  $27,982   $8,106  $6,536 
  

 

   

 

   

 

  

 

   

 

  

 

 

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

 

Page 2


MERIDIAN BIOSCIENCE, INC. AND SUBSIDIARIES

Condensed Consolidated Statements of Cash Flows (Unaudited)

(in thousands)

 

Nine Months Ended June 30,

  2015 2014 

Three Months Ended December 31,

  2015 2014 

CASH FLOWS FROM OPERATING ACTIVITIES

      

Net earnings

  $27,073  $26,561   $8,893  $7,901 

Non-cash items included in net earnings:

      

Depreciation of property, plant and equipment

   2,585  2,634    896  927 

Amortization of intangible assets

   1,309  1,549    388  469 

Amortization of deferredillumigene instrument costs

   1,088  1,281 

Amortization of deferredillumigene® instrument costs

   281  395 

Stock-based compensation

   2,676  2,662    1,611  1,428 

Deferred income taxes

   (270 (438   433  100 

Loss on disposition and write-down of fixed assets and other assets

   39  22 

Change in current assets

   (4,399 (6,804   (1,186 4,878 

Change in current liabilities

   796  (4,055   834  246 

Other, net

   299  199    (58 (259
  

 

  

 

   

 

  

 

 

Net cash provided by operating activities

   31,196  23,611    12,092  16,085 
  

 

  

 

   

 

  

 

 

CASH FLOWS FROM INVESTING ACTIVITIES

      

Purchases of property, plant and equipment

   (3,783 (3,968   (776 (1,331

Proceeds from sale of assets

   1,138   —   

Purchase of equity method investment

   (600  —   

Purchases of intangible assets

   —    (1,687   (16  —   
  

 

  

 

   

 

  

 

 

Net cash used for investing activities

   (2,645 (5,655   (1,392 (1,331
  

 

  

 

 
  

 

  

 

 

CASH FLOWS FROM FINANCING ACTIVITIES

      

Dividends paid

   (25,014 (24,464   (8,407 (8,330

Proceeds and tax benefits from exercises of stock options

   654  629    1,470  499 
  

 

  

 

   

 

  

 

 

Net cash used for financing activities

   (24,360 (23,835   (6,937 (7,831
  

 

  

 

 
  

 

  

 

 

Effect of Exchange Rate Changes on Cash and Equivalents

   (1,263 882    (314 (454
  

 

  

 

   

 

  

 

 

Net Increase (Decrease) in Cash and Equivalents

   2,928  (4,997

Net Increase in Cash and Equivalents

   3,449  6,469 

Cash and Equivalents at Beginning of Period

   43,047  44,282    49,973  43,047 
  

 

  

 

   

 

  

 

 

Cash and Equivalents at End of Period

  $45,975  $39,285   $53,422  $49,516 
  

 

  

 

   

 

  

 

 

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,
2015
   September 30,
2015
 
  June 30,
2015

(Unaudited)
   September 30,
2014
   (Unaudited)     

CURRENT ASSETS

        

Cash and equivalents

  $45,975   $43,047   $53,422   $49,973 

Accounts receivable, less allowances of $256 and $272

   27,963    23,232 

Accounts receivable, less allowances of $222 and $248

   27,617    26,254 

Inventories

   33,592    35,495    38,778    35,817 

Prepaid expenses and other current assets

   6,439    7,058    3,414    7,378 

Deferred income taxes

   4,006    3,916 
  

 

   

 

 
  

 

   

 

 

Total current assets

   117,975    112,748    123,231    119,422 
  

 

   

 

 
  

 

   

 

 

PROPERTY, PLANT AND EQUIPMENT, at Cost

        

Land

   984    1,173    981    986 

Buildings and improvements

   29,872    29,146    30,119    30,056 

Machinery, equipment and furniture

   41,761    40,192    42,363    41,541 

Construction in progress

   535    652    938    1,139 
  

 

   

 

   

 

   

 

 

Subtotal

   73,152    71,163    74,401    73,722 

Less: accumulated depreciation and amortization

   45,771    43,553    46,952    46,230 
  

 

   

 

   

 

   

 

 

Net property, plant and equipment

   27,381    27,610    27,449    27,492 
  

 

   

 

 
  

 

   

 

 

OTHER ASSETS

        

Goodwill

   22,784    23,193    22,064    22,349 

Other intangible assets, net

   6,374    7,813    5,465    5,931 

Restricted cash

   1,000    1,000    1,000    1,000 

Deferredillumigene instrument costs, net

   2,000    2,740    1,671    1,750 

Deferred income taxes

   1,398    1,483    4,566    4,954 

Other assets

   404    342    989    384 
  

 

   

 

   

 

   

 

 

Total other assets

   33,960    36,571    35,755    36,368 
  

 

   

 

 
  

 

   

 

 

TOTAL ASSETS

  $179,316   $176,929   $186,435   $183,282 
  

 

   

 

   

 

   

 

 

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

 

Page 4


MERIDIAN BIOSCIENCE, INC. AND SUBSIDIARIES

Condensed Consolidated Balance Sheets

(dollars in thousands)

LIABILITIES AND SHAREHOLDERS’ EQUITY

 

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

(Unaudited)
 September 30,
2014
   (Unaudited)   

CURRENT LIABILITIES

      

Accounts payable

  $5,453  $4,966   $7,208  $6,646 

Accrued employee compensation costs

   4,236  4,761    4,990  5,132 

Other accrued expenses

   2,630  3,149    2,601  2,587 

Income taxes payable

   969  859    933  886 
  

 

  

 

   

 

  

 

 

Total current liabilities

   13,288  13,735    15,732  15,251 
  

 

  

 

   

 

  

 

 

NON-CURRENT LIABILITIES

   2,097  2,165    2,129  2,158 

COMMITMENTS AND CONTINGENCIES

      

SHAREHOLDERS’ EQUITY

      

Preferred stock, no par value, 1,000,000 shares authorized, none issued

   —     —   

Common shares, no par value, 71,000,000 shares authorized, 41,714,185 and 41,622,216 shares issued, respectively

   —     —   

Preferred stock, no par value; 1,000,000 shares authorized; none issued

   —     —   

Common shares, no par value; 71,000,000 shares authorized; 42,044,388 and 41,838,399 shares issued, respectively

   —     —   

Additional paid-in capital

   114,840  111,851    120,153  117,151 

Retained earnings

   50,928  48,869    51,538  51,052 

Accumulated other comprehensive income

   (1,837 309 
  

 

  

 

 

Accumulated other comprehensive income (loss)

   (3,117 (2,330
  

 

  

 

 

Total shareholders’ equity

   163,931  161,029    168,574  165,873 
  

 

  

 

   

 

  

 

 

TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY

  $179,316  $176,929   $186,435  $183,282 
  

 

  

 

   

 

  

 

 

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

 

Page 5


MERIDIAN BIOSCIENCE, INC. AND SUBSIDIARIES

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

(dollars and shares in thousands)

 

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

Balance at September 30, 2014

   41,622   $111,851   $48,869  $309  $161,029 

Balance at September 30, 2015

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

Cash dividends paid

   —      —      (25,014  —    (25,014   —      —      (8,407  —    (8,407

Exercise of stock options

   65    313    —     —    313    91    1,391    —     —    1,391 

Conversion of restricted stock units

   27    —      —     —     —      115    —      —     —     —   

Stock compensation expense

   —      2,676    —     —    2,676    —      1,611    —     —    1,611 

Net earnings

   —      —      27,073   —    27,073    —      —      8,893   —    8,893 

Foreign currency translation adjustment

   —      —      —    (2,146 (2,146   —      —      —    (787 (787
  

 

   

 

   

 

  

 

  

 

   

 

   

 

   

 

  

 

  

 

 

Balance at June 30, 2015

   41,714   $114,840   $50,928  $(1,837 $163,931 

Balance at December 31, 2015

   42,044   $120,153   $51,538  $(3,117 $168,574 
  

 

   

 

   

 

  

 

  

 

   

 

   

 

   

 

  

 

  

 

 

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

1.Basis of Presentation

The interim condensed consolidated financial statements are unaudited and are prepared in accordance with accounting principles generally accepted in the United States of America for interim financial information, and the rules and regulations of the Securities and Exchange Commission. Certain information and footnote disclosures normally included in financial statements prepared in accordance with generally accepted accounting principles have been condensed or omitted pursuant to such rules and regulations. In the opinion of Management, the interim financial statements include all normal adjustments and disclosures necessary to present fairly the Company’s financial position as of June 30,December 31, 2015, the results of its operations for the three and nine month periods ended June 30,December 31, 2015 and 2014, and its cash flows for the ninethree month periods ended June 30,December 31, 2015 and 2014. These statements should be read in conjunction with the consolidated financial statements and footnotes thereto included in the Company’s fiscal 20142015 Annual Report on Form 10-K. Financial information as of September 30, 20142015 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

2.Significant Accounting Policies

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

 

(a)Revenue Recognition and Accounts ReceivableRecent Accounting Pronouncements

Revenue is generally recognized from sales when product is shipped and title has passed toIn November 2015, the customer. Revenue forFASB issued ASU 2015-17,Balance Sheet Classification of Deferred Taxes, which simplifies the Diagnostics segment is reduced at the datefinancial statement presentation of sale for product price adjustments due certain distributors under local contracts. Management estimates accruals for distributor price adjustments based on local contract terms, sales data provideddeferred income taxes by distributors, estimates of inventories of certain of our products held by distributors, historical statistics, current trends, and other factors. Changes to the accruals are recorded in the periodrequiring that they become known. Such accruals were $4,431 at June 30, 2015 and $4,220 at September 30, 2014, and have been netted against accounts receivable.

Revenue for our Diagnostics segment includes revenue for ourillumigene® molecular test system. This system includes an instrument, instrument accessories and test kits. In markets where the test system is sold via multiple deliverable arrangements, the cost of the instrument and instrument accessories is deferred upon placement at a customer and amortized on a straight-line basis into cost of sales over the expected utilization period, generally three years.

We evaluate whether each deliverable in the arrangement is a separate unit of accounting. The significant deliverables are an instrument, instrument accessories (e.g., printer) and test kits. An instrument and instrument accessories are delivered to the customer prior to the start of the customer utilization period, in order to accommodate customer set-up and installation. There isde minimis consideration received from the customer at the time of instrument placement. We have determined that the instrument and instrument accessories are not a separate unit of accounting because such equipment can only be used to process and read the results from ourillumigene diagnostic tests (i.e., our instrument and test kits function together to deliver a diagnostic test result), and therefore the instrument and instrument accessories do not have standalone value to the customer. Consequently, there is no revenue allocated to the placement of the instrument and instrument accessories. Test kits are delivered to the customer over the utilization period of the instrument, which we estimate has a useful life of three years. Our average customer contract period, including estimated renewals, is at least equal to the estimated three-year utilization period. Revenue for the sale of test kits is recognized upon shipment and transfer of title to the customers.

Page 7


In markets where the test system is not sold via multiple deliverable arrangements, the cost of the instrument and instrument accessories is charged to cost of sales at the time of shipment and transfer of title to the customer. Revenue for the sales of instruments and instrument accessories and test kits is recognized upon shipment and transfer of title to the customers. In these markets, ourillumigenemolecular test system is sold to independent distributors who inventory the instruments, instrument accessories and test kits for resale to end-users.

Our products are generally not subject to a customer right of return except for product recall events under the rules and regulations of the Food and Drug Administration or equivalent agencies outside the United States. In this circumstance, the costs to replace affected products would be accrued at the time a loss was considered to be probable and estimable.

Life Science revenue for contract services may come from research and development services or manufacturing services, including process development work, or a combination of both. Revenue is recognized based on each of the deliverables in a given arrangement having distinct and separate customer pricing. Depending on the nature of the arrangement, revenue is recognized as services are performed and billed, upon completion and acceptance by the customer, or upon delivery of product and acceptance by the customer.

Trade accounts receivable are recorded in the accompanying Condensed Consolidated Balance Sheets at invoiced amounts less provisions for distributor price adjustments under local contracts and doubtful accounts. The allowance for doubtful accounts represents our estimate of probable credit losses and is based on historical write-off experience and known conditions that would likely lead to non-payment. The allowance for doubtful accounts and related metrics, such as days’ sales outstanding, are reviewed monthly. Accounts with past due balances over 90 days are reviewed individually for collectibility. Customer invoices are charged off against the allowance when we believe it is probable that the invoices will not be paid.

(b)Comprehensive Income (Loss) –

As reflected in the accompanying Condensed Consolidated Statements of Comprehensive Income, our comprehensive income or loss is comprised of net earnings and foreign currency translation.

Assets and liabilities of foreign operations are translated using period-end exchange rates with gains or losses resulting from translation included as a separate component of comprehensive income or loss. Revenues and expenses are translated using exchange rates prevailing during the period. We also recognize foreign currency transaction gains and losses on certaintax assets and liabilities that are denominatedbe classified as noncurrent within a classified statement of financial position. Adoption and implementation of the guidance is not required by the Company until issuance of fiscal 2018 first quarter financial statements. However, in light of early adoption being permitted and believing the required presentation results in more useful and comparable information related to our net deferred income tax assets, the Company has chosen to adopt the guidance as of December 31, 2015 and retrospectively apply the guidance to the prior period presented. This retrospective application results in $3,431 of deferred income tax assets being reclassified from current assets to non-current assets in the non-functional currenciesSeptember 30, 2015 balance sheet included herein. Adoption of the Company or its subsidiaries. These gains and losses are included in other income and expense in the accompanying Condensed Consolidated Statements of Operations.

(c)Income Taxes –

The provision for income taxes includes federal, foreign, state and local income taxes currently payable and those deferred because of temporary differences between income for financial reporting and income for tax purposes. We prepare estimates of permanent and temporary differences between income for financial reporting purposes and income for tax purposes. These differences are adjusted to actual upon filing of our tax returns, typically occurring in the third and fourth quarters of the current fiscal year for the preceding fiscal year’s estimates.

We account for uncertain tax positions using a benefit recognition model with a two-step approach: (i) a more-likely-than-not recognition criterion; and (ii) a measurement attribute that measures the position as the largest amount of tax benefit that is greater than 50% likely of being ultimately realized upon settlement. If it is not more likely than not that the benefit will be sustained on its technical merits, no benefit is recorded. We recognize accrued interest and penalties related to unrecognized tax benefits as a portion of our income tax provision in the Condensed Consolidated Statements of Operations.

In September 2013, the Internal Revenue Service issued Treasury Decision 9636, which enacted final tax regulations regarding the capitalization and expensing of amounts paid to acquire, produce or improve tangible property. The regulations also includethis guidance regarding the retirement of depreciable property. Our adoption of these regulations on October 1, 2014 did not have a significantan impact on the Company’s consolidated results of operations or cash flows or financial position.

flows.

Page 8


(d)Stock-Based Compensation –

We recognize compensation expense for all share-based awards madeIssued but not yet effective accounting pronouncements are not expected to employees, based upon the fair value of the share-based awardhave a material impact on the date of the grant. Awards are expensed over their requisite service periods. For awards which vest solely on future service, we begin to expense such awards on the date of grant. For awards with performance conditions, we begin to expense such awards in the period upon which we believe there is sufficient evidence to support that it is probable that the performance condition(s) will be achieved.Condensed Consolidated Financial Statements.

 

(e)Cash and Cash Equivalents –

Cash and cash equivalents include the following components:

   June 30, 2015   September 30, 2014 
   Cash and
Equivalents
   Other
Assets
   Cash and
Equivalents
   Other
Assets
 

Overnight repurchase agreements

  $23,315   $—     $26,407   $—   

Cash on hand -

        

Restricted

   —      1,000    —      1,000 

Unrestricted

   22,660    —      16,640    —   
  

 

 

   

 

 

   

 

 

   

 

 

 

Total

  $45,975   $1,000   $43,047   $1,000 
  

 

 

   

 

 

   

 

 

   

 

 

 

(f)Recent Accounting Pronouncements –

In May 2014, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2014-09,Revenue from Contracts with Customers, which supersedes and replaces nearly all currently-existing U.S. GAAP revenue recognition guidance including related disclosure requirements. Considering the FASB’s recent effective date deferral, this guidance will be effective for the Company beginning October 1, 2018 (fiscal 2019). The Company has not yet completed its assessment of the impact that adoption of this guidance will have on its financial statements.

(g)(b)Reclassifications

Certain reclassifications have been made to the prior fiscal period financial statements to conform to the current fiscal period presentation. Such reclassifications had no impact on net earnings or shareholders’ equity.

 

3.Inventories

Page 7


3.Cash and Equivalents

Cash and equivalents include the following components:

   December 31, 2015   September 30, 2015 
   Cash and
Equivalents
   Other
Assets
   Cash and
Equivalents
   Other
Assets
 

Overnight repurchase agreements

  $25,147   $—     $25,436   $—   

Cash on hand—

        

Restricted

   —      1,000    —      1,000 

Unrestricted

   28,275    —      24,537    —   
  

 

 

   

 

 

   

 

 

   

 

 

 

Total

  $53,422   $1,000   $49,973   $1,000 
  

 

 

   

 

 

   

 

 

   

 

 

 

4.Inventories

Inventories are comprised of the following:

 

  June 30, 2015   September 30,
2014
   December 31,
2015
   September 30,
2015
 

Raw materials

  $6,637   $5,674   $7,351   $7,095 

Work-in-process

   9,189    10,591    12,297    10,096 

Finished goods -illumigene instruments

   1,277    1,710 

Finished goods - kits and reagents

   16,489    17,520 

Finished goods—illumigene instruments

   2,260    1,890 

Finished goods—kits and reagents

   16,870    16,736 
  

 

   

 

   

 

   

 

 

Total

  $33,592   $35,495   $38,778   $35,817 
  

 

   

 

   

 

   

 

 

5.Reportable Segment and Major Customers Information

Page 9


4.Reportable Segment and Major Customers Information

Meridian was formed in 1976 and functions as a fully-integrated research, development, manufacturing, marketing and sales organization with primary emphasis in the fields of in vitro diagnostics and life science. Our principal businesses are (i) the development, manufacture and distribution of diagnostic test kits primarily for gastrointestinal, viral, respiratory and parasitic infectious diseases; and (ii) the manufacture and distribution of bulk antigens, antibodies, PCR/qPCR reagents, nucleotides, competent cells and bioresearch reagents used by researchers and other diagnostic manufacturers, and the contract development and manufacture of proteins and other biologicals for use by biopharmaceutical and biotechnology companies engaged in research for new drugs and vaccines.

Our reportable segments are Diagnostics and Life Science, both of which are headquartered in Cincinnati, Ohio, which also serves as the Diagnostics segment’s base of manufacturing operations and research and development. The Diagnostics segment has sales and distribution facilities in the United States, Europe and Australia. The Life Science segment consists of manufacturing operations in Memphis, Tennessee; Boca Raton, Florida; London, England; Luckenwalde, Germany; and Sydney, Australia, and the sale and distribution of bulk antigens, antibodies, PCR/qPCR reagents, nucleotides, competent cells and bioresearch reagents domestically and abroad, including sales and business development offices in Singapore and Beijing, China to further pursue growing revenue opportunities in Asia. The Life Science segment also includes the contract development and manufacture of cGMP clinical grade proteins and other biologicals for use by biopharmaceutical and biotechnology companies engaged in research for new drugs and vaccines.

Amounts due from two Diagnostics distributor customers accounted for 23%26% and 15%21% of consolidated accounts receivable at June 30,December 31, 2015 and September 30, 2014,2015, respectively. Revenues from these two distributor customers accounted for 35%39% and 36%41% of the Diagnostics segment’ssegment third-party revenues during the three months ended June 30,December 31, 2015 and 2014, respectively,respectively; and 36% during each of the nine months ended June 30, 2015represented 29% and 2014. These distributors represented 27%31% of consolidated revenues for each of the fiscal 2016 and 2015 and 2014 thirdfirst quarters, and 27% and 28% for the fiscal 2015 and 2014 year-to-date nine month periods, respectively. In addition, approximately $2,000 and $2,700 of our consolidated accounts receivable at June 30, 2015 and September 30, 2014, respectively, was due from Italian hospital customers whose funding ultimately comes from the Italian government, representing 7% and 12% of consolidated accounts receivable in each of the respective periods.

Page 8


Within our Life Science segment, two diagnostic manufacturing customers accounted for 16%18% of the segment’s third-party revenues during each of the three months ended June 30,December 31, 2015 and 2014, and 16% and 17% during the nine months ended June 30, 2015 and 2014, respectively.2014.

Page 10


Segment information for the interim periods is as follows:

 

   Diagnostics   Life Science   Eliminations(1)   Total 

Three Months Ended June 30, 2015

        

Net revenues -

        

Third-party

  $36,049   $12,155   $—     $48,204 

Inter-segment

   46    345    (391   —   

Operating income

   11,203    3,240    (45   14,398 

Goodwill (June 30, 2015)

   1,250    21,534    —      22,784 

Other intangible assets, net (June 30, 2015)

   2,436    3,938    —      6,374 

Total assets (June 30, 2015)

   117,602    61,955    (241   179,316 

Three Months Ended June 30, 2014

        

Net revenues -

        

Third-party

  $35,168   $12,044   $—     $47,212 

Inter-segment

   99    374    (473   —   

Operating income

   10,526    2,676    (70   13,132 

Goodwill (September 30, 2014)

   1,250    21,943    —      23,193 

Other intangible assets, net (September 30, 2014)

   2,756    5,057    —      7,813 

Total assets (September 30, 2014)

   109,350    67,834    (255   176,929 

Nine Months Ended June 30, 2015

        

Net revenues -

        

Third-party

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

Inter-segment

   235    867    (1,102   —   

Operating income

   33,081    9,814    (96   42,799 

Nine Months Ended June 30, 2014

        

Net revenues -

        

Third-party

  $107,066   $35,074   $—     $142,140 

Inter-segment

   362    858    (1,220   —   

Operating income

   32,211    8,243    (30   40,424 
   Diagnostics   Life Science   Eliminations(1)   Total 

Three Months Ended December 31, 2015

  

Net revenues—

        

Third-party

  $35,301   $11,859   $—     $47,160 

Inter-segment

   71    367    (438   —   

Operating income

   10,330    3,236    20    13,586 

Goodwill (December 31, 2015)

   1,250    20,814    —      22,064 

Other intangible assets, net (December 31, 2015)

   2,236    3,229    —      5,465 

Total assets (December 31, 2015)

   120,780    65,927    (272   186,435 

Three Months Ended December 31, 2014

        

Net revenues—

        

Third-party

  $36,586   $11,427   $—     $48,013 

Inter-segment

   104    297    (401   —   

Operating income

   10,284    2,489    (104   12,669 

Goodwill (September 30, 2015)

   1,250    21,099    —      22,349 

Other intangible assets, net (September 30, 2015)

   2,364    3,567    —      5,931 

Total assets (September 30, 2015)

   119,939    63,670    (327   183,282 

 

(1)Eliminations consist of inter-segment transactions.

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

6.Intangible Assets

Page 11


5.Intangible Assets

A summary of our acquired intangible assets subject to amortization, as of June 30,December 31, 2015 and September 30, 2014,2015 is as follows:

 

  June 30, 2015   September 30, 2014 
  Gross
Carrying
Value
   Accumulated
Amortization
   Gross
Carrying
Value
   Accumulated
Amortization
   December 31, 2015   September 30, 2015 
  Gross
Carrying
Value
   Accumulated
Amortization
   Gross
Carrying
Value
   Accumulated
Amortization
 

Manufacturing technologies, core products and cell lines

  $11,635   $10,849   $11,685   $10,568   $11,547   $10,963   $11,582   $10,906 

Trademarks, licenses and patents

   6,390    3,167    6,463    2,766    6,349    3,450    6,410    3,296 

Customer lists and supply agreements

   12,246    9,881    12,378    9,379    12,012    10,030    12,105    9,964 
  

 

   

 

   

 

   

 

   

 

   

 

   

 

   

 

 
  $30,271   $23,897   $30,526   $22,713   $29,908   $24,443   $30,097   $24,166 
  

 

   

 

   

 

   

 

   

 

   

 

   

 

   

 

 

Page 9


The actual aggregate amortization expense for these intangible assets was $409$388 and $507$469 for the three months ended June 30, 2015 and 2014, respectively, and $1,309 and $1,549 for the nine months ended June 30,December 31, 2015 and 2014, respectively. The estimated aggregate amortization expense for these intangible assets for each of the fiscal years through fiscal 20202021 is as follows: remainder of fiscal 2015 – $402, fiscal 2016 – $1,369,$1,009, fiscal 2017 – $1,141,$1,106, fiscal 2018 – $1,120,$1,085, fiscal 2019 – $1,079 and$1,045, fiscal 2020 – $903.$873 and fiscal 2021 – $313.

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

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

Following is a discussion and analysis of the financial statements and other statistical data that management believes will enhance the understanding of Meridian’s financial condition, changes in financial condition and results of operations. This discussion should be read in conjunction with the financial statements and notes thereto beginning on page 1.

RESULTS OF OPERATIONS

Quarterly Highlights

As more fully detailed below, the third quarterResults of fiscal 2015 was highlighted by our Diagnostics segment’s launch of our newest molecular-based tests for the detection of Herpes Simplex Virus Type 1 (“HSV-1”) and Type 2 (“HSV-2”) outside of the U.S. and our Life Science segment’s continued successful expansion into China, as revenues from sales into China now exceed $1,500 in fiscal 2015 year-to-date. During July 2015, we received FDA clearance for ourillumigene®HSV 1&2 tests and began selling in the U.S. market.

Three Months Ended June 30, 2015Operations

Net earnings for the thirdfirst quarter of fiscal 20152016 increased 3%13% to $9,102,$8,893, or $0.22$0.21 per diluted share, from net earnings for the thirdfirst quarter of fiscal 20142015 of $8,835,$7,901, or $0.21$0.19 per diluted share. This increase reflects the combined effects of increased revenues, increased gross profit margins and slightly decreased operating expenses. Also impacting the quarterly results was an increase in the effective tax rate, as discussed below, which had an approximate $0.01 impact on diluted earnings per share. Consolidated revenues increaseddecreased 2% to $48,204$47,160 for the thirdfirst quarter of fiscal 20152016 compared to the same period of the prior year increasing 5%and were flat on a constant-currency basis.

Page 12


Included within the thirdfirst quarter 2015 resultsof fiscal 2016 were revenues from ourillumigene®molecular platform of products totaling $10,500,$9,836, representing a 10% increase over1% decrease from the fiscal 2014 third quarter.2015 first quarter (flat on a constant-currency basis). Also contributing to the increase in consolidated revenues decrease were increaseddecreased revenues in twothree of our diagnostic focus product families (H. pyloriC. difficile, foodborne and respiratory) and our Life Science segment’s immunoassay components business.molecular component business line. Serving to partiallysubstantially offset these increasesdecreases were decreasedincreased revenues in ourC. difficileH. pylori and foodbornewomen’s health & STD focus product families and our Life Science segment’s molecularimmunoassay components business.

Revenues for the Diagnostics segment for the thirdfirst quarter of fiscal 2016 decreased 4% compared to the first quarter of fiscal 2015 increased 3% compared to the third quarter of fiscal 2014 (5%(decreased 2% on a constant-currency basis), reflecting the following for each of our focus product families: 8%2% decline in ourC. difficile products, 9% decline in our respiratory products, 11% decline in our foodborne products, 7% growth in our women’s health & STD products, and 19% growth in ourH. pylori products, 35% growth in our respiratory products, 2% decline in our foodborne products, and 8% decline in ourC. difficileproducts. As it relates to our respiratory products, the growth was driven by several products in both our molecular and immunoassay categories. Our molecular products (illumigene Group A Strep,illumigene Mycoplasma andillumigene Pertussis) experienced volume growth from new assay placements. Our immunoassay products (influenza and Mycoplasma) experienced growth in distribution channels. With growth in its immunoassay componentscomponent business and a decline in its molecular components business, revenues of our Life Science segment increased by 1%4% during the thirdfirst quarter of fiscal 20152016 compared to the thirdfirst quarter of fiscal 2014, increasing 5% on a constant-currency basis.

Nine Months Ended June 30, 2015,

For the nine month period ended June 30, 2015, net earnings increased 2% to $27,073, or $0.64 per diluted share, from net earnings for the comparable fiscal 2014 period of $26,561, or $0.63 per diluted share. This increase reflects the combined effects of increased revenues, slightly decreased gross profit margins and increased operating expenses. Consolidated revenues increased 4% to $147,762 for the first nine months of fiscal 2015 compared to the same period of the prior fiscal year, increasing 6% on a constant-currency basis.

Included withinAdditionally, during November 2015, we made a minority investment in Oasis Diagnostics® Corporation (“Oasis”), with the nine month year-to-date fiscal 2015 results were revenues from ourillumigene molecular platformright to acquire 100% ownership interest in the future. Located in Vancouver, Washington, Oasis designs, develops, manufactures and sells pre-analytic tools for the collection, preservation, and transportation of products totaling $30,600, representing a 10% increase over the first nine months of fiscal 2014. Also contributing to the consolidated revenue increase were increased revenues in three of our diagnostic focus product families (H. pylori, foodborne and respiratory)saliva/oral fluids – and our Life Science segment’s immunoassay components business. Servinginvestment was made to partially offset these increases were decreased revenuesexplore our interest in ourC. difficile focus product familysaliva diagnostics and our Life Science segment’s molecular components business.collection devices. Our investment in Oasis has been accounted for as an equity method investment and is included within other assets in the accompanying Condensed Consolidated Balance Sheet as of December 31, 2015.

During the first nine months of fiscal 2015, revenues for the Diagnostics segment increased 4% from the comparable fiscal 2014 period (6% on a constant-currency basis), reflecting the following for each of our focus product families: 10% growth in ourH. pylori products, 10% growth in our foodborne products, 23% growth in our respiratory products, and 10% decline in ourC. difficile products. During the first nine months of fiscal 2015, revenues for our Life Science segment increased 4%, 7% on a constant-currency basis.

Page 10


REVENUE OVERVIEW

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

- By Reportable Segment & Geographic Region

- By Product Platform/Type

- By Disease Family (Diagnostics only)

Revenue Overview- By Reportable Segment & Geographic Region

Our reportable segments are Diagnostics and Life Science. The Diagnostics segment consists of manufacturing operations in Cincinnati, Ohio, and the sale and distribution of diagnostic test kits in the countries comprising North, Central and South America (the “Americas”); Europe, Middle East and Africa (“EMEA”); and other countries outside of the Americas and EMEA (rest of the world, or “ROW”). The Life Science segment consists of manufacturing operations in Memphis, Tennessee; Boca Raton, Florida; London, England; Luckenwalde, Germany; and Sydney, Australia, and the sale and distribution of bulk antigens, antibodies, PCR/qPCR reagents, nucleotides, competent cells and bioresearch reagents domestically and abroad, including a sales and business development locationoffices in Singapore. Additionally, in orderSingapore and Beijing, China to further pursue growing revenue opportunities in Asia, and China in

Page 13


particular, our Life Science segment has opened a business development office in Beijing, China. The Life Science segment also includes the contract development and manufacture of cGMP clinical grade proteins and other biologicals for use by biopharmaceutical and biotechnology companies engaged in research for new drugs and vaccines.Asia.

Revenues for the Diagnostics segment, in the normal course of business, may be affected from quarter to quarter by buying patterns of major distributors, seasonality and strength of certain diseases, and foreign currency exchange rates. Revenues for the Life Science segment, in the normal course of business, may be affected from quarter to quarter by the timing and nature of arrangements for contract services work, which may have longer production cycles than bioresearch reagents and bulk antigens and antibodies, as well as buying patterns of major customers and foreign currency exchange rates. We believe that the overall breadth of our product lines serves to reduce the variability in consolidated revenues due to these factors.

 

  Three Months Ended June 30, Nine Months Ended June 30,   Three Months Ended December 31, 
  2015 2014 Inc (Dec) 2015 2014 Inc (Dec)   2015 2014 Inc (Dec) 

Diagnostics-

           

Americas

  $30,410  $28,881  5 $93,502  $87,454  7  $30,115  $30,913  (3)% 

EMEA

   4,651  5,485  (15)%  15,184  16,810  (10)%    4,649  5,003  (7)% 

ROW

   988  802  23 2,611  2,802  (7)%    537  670  (20)% 
  

 

  

 

  

 

  

 

  

 

  

 

   

 

  

 

  

 

 

Total Diagnostics

   36,049  35,168  3 111,297  107,066  4   35,301  36,586  (4)% 
  

 

  

 

  

 

  

 

  

 

  

 

   

 

  

 

  

 

 

Life Science-

           

Americas

   5,065  4,842  5 16,274  14,257  14   5,103  5,299  (4)% 

EMEA

   4,877  5,278  (8)%  13,637  15,287  (11)%    4,536  3,758  21 

ROW

   2,213  1,924  15 6,554  5,530  19   2,220  2,370  (6)% 
  

 

  

 

  

 

  

 

  

 

  

 

   

 

  

 

  

 

 

Total Life Science

   12,155  12,044  1 36,465  35,074  4   11,859  11,427  
  

 

  

 

  

 

  

 

  

 

  

 

   

 

  

 

  

 

 

Consolidated

  $48,204  $47,212  2 $147,762  $142,140  4  $47,160  $48,013  (2)% 
  

 

  

 

  

 

  

 

  

 

  

 

   

 

  

 

  

 

 

% of total revenues-

           

Diagnostics

   75 74  75 75    75  76  

Life Science

   25 26  25 25    25  24  
  

 

  

 

   

 

  

 

    

 

  

 

  

Total

   100 100  100 100    100  100  
  

 

  

 

   

 

  

 

    

 

  

 

  

Ex-Americas

   26 29  26 28    25  25  
  

 

  

 

   

 

  

 

    

 

  

 

  

 

Page 1411


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

1)Molecular tests that operate on ourillumigene platform

2) Immunoassay tests on multiple technology platforms

2)Immunoassay tests on multiple technology platforms

Life Science

1) Molecular components

1)Molecular components

2) Immunoassay components

2)Immunoassay components

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

 

  Three Months Ended June 30, Nine Months Ended June 30,   Three Months Ended December 31, 
  2015 2014 Inc (Dec) 2015 2014 Inc (Dec)   2015 2014 Inc (Dec) 

Diagnostics-

           

Molecular tests

  $10,550  $9,578  10 $30,650  $27,865  10

Immunoassay tests

   25,499  25,590  —   80,647  79,201  2

Molecular

  $9,836  $9,908  (1)% 

Immunoassay

   25,465  26,678  (5)% 
  

 

  

 

  

 

  

 

  

 

  

 

   

 

  

 

  

 

 

Total Diagnostics

  $36,049  $35,168  3 $111,297  $107,066  4  $35,301  $36,586  (4)% 
  

 

  

 

  

 

  

 

  

 

  

 

 
  

 

  

 

  

 

 

Life Science-

           

Molecular components

  $5,104  $5,476  (7)%  $15,009  $15,369  (2)%   $4,749  $5,012  (5)% 

Immunoassay components

   7,051  6,568  7 21,456  19,705  9   7,110  6,415  11 
  

 

  

 

  

 

  

 

  

 

  

 

   

 

  

 

  

 

 

Total Life Science

  $12,155  $12,044  1 $36,465  $35,074  4  $11,859  $11,427  
  

 

  

 

  

 

  

 

  

 

  

 

   

 

  

 

  

 

 

% of Diagnostics revenues-

           

Molecular tests

   29 27  28 26 

Immunoassay tests

   71 73  72 74 

Molecular

   28  27  

Immunoassay

   72  73  
  

 

  

 

   

 

  

 

    

 

  

 

  

Total Diagnostics

   100 100  100 100    100  100  
  

 

  

 

   

 

  

 

  
  

 

  

 

  

% of Life Science revenues-

           

Molecular components

   42 45  41 44    40  44  

Immunoassay components

   58 55  59 56    60  56  
  

 

  

 

   

 

  

 

    

 

  

 

  

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

illumigene Molecular Platform Products

Following our launch outside the U.S. ofillumigeneHSV 1&2 during the third quarter of fiscal 2015 andillumigene Chlamydia trachomatis andillumigeneNeisseria gonorrhea during the second quarter of fiscal 2015, we nowWe have approximately 1,4251,490 customer account placements. Of these account placements, approximately 1,275over 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 approximatelyover 400 accounts that are regularly purchasing, evaluating and/or validating two or more assays.

Page 15


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

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

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

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

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

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

 

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

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


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

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

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

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

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

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

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

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

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

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

AdditionalWe have several additionalillumigene tests in researchdevelopment and development include foodborne pathogens such ashave a robust pipeline ofCampylobacter jejuniillumi, and bloodborne pathogens such asgene opportunities. We continue to add new assays to ourillumigene platform menu, with our latest being malaria, which was launched in the causative agents for malaria.EMEA region in February 2016.

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

Immunoassay Products

OurRevenues from our Diagnostics segment’s revenues from immunoassay products decreased less than 1% for5% in the first quarter and increased 2% on a nine month, year-to-date basis.of fiscal 2016. As described in the product discussions below, the quarterly revenue growth of ourH. pylori and respiratory products was slightly more than offset bycurrent year decrease results primarily from the decline in revenues fromof our foodborne, andC. difficile products. The year-to-date increase results primarily from the revenue growth of ourH. pylori, foodborne and respiratory immunoassay products, partially offset by the declinerevenue increase in revenues from ourC. difficileH. pylori products.

Life Science Products

During the thirdfirst quarter of fiscal 2015, revenues from our Life Science segment increased 1%, with revenues from molecular components sales decreasing 7% from the comparable fiscal 2014 quarter and revenues from immunoassay components sales increasing 7%. For the first nine months of fiscal 2015,2016, revenues from our Life Science segment increased 4%, with revenues from molecular componentscomponent sales decreasing 2%5% from the comparable prior year periodfiscal 2015 quarter and revenues from immunoassay componentscomponent sales increasing 9%11%. Our molecular componentscomponent business’ growth was negatively impacted by the movement in currency exchange rates since the 2014 thirdfiscal 2015 first quarter, with the revenues increasing 2% and 4%less than 1% on a constant-currency basis forover the quarterly and year-to-date periods, respectively.fiscal 2015 first quarter. Our Life Science segment continued to benefit from increased sales into China, with such sales totaling approximately $1,600 for$500 during the fiscal 2016 first nine months of fiscal 2015 (approximately $400 in the molecular components business and $1,200quarter (primarily in the immunoassay components business).

DiagnosticDiagnostics Revenue Overview- By Disease Family

Revenues from our focus families (C. difficile, foodborne,H. pylori, respiratory and respiratory)women’s health & STD) comprised 74%81% and 78% of our Diagnostics segment’s revenuerevenues during the thirdfirst quarter and first nine months of fiscal 2016 and 2015, and 73% for both of the comparable fiscal 2014 periods.respectively. Following is a discussion of the revenues generated by each product family:

C. difficile Products

RevenuesDuring the fiscal 2016 first quarter, revenues for ourC. difficile product family decreased 8%2% to $8,200 for$7,400 from the first quarter of fiscal 2015 third quarter, and decreased 10% to $24,000 for the nine month, year-to-date period.(flat in constant-currency). Our molecular products now represent approximatelyover 80% of this product category, and new customers are being added each quarter.category. TheC. difficile test market continues to be highly competitive, with over 10 suppliers in the United States, certain of which choose to compete solely on

Page 16


price. During the first quarter of fiscal 2016, the amount and rate of decline in constant-currency revenues has continued to decrease. We believe thatthis is due largely to the following factors will help us respond to these highly competitive market conditions: (i) our marketing programs emphasize that we are the only company that can offer a full rangeexpansion of high performing, FDA cleared,C. difficile testing formats, including toxin, GDH and molecular tests; (ii) ourillumigene molecular platform with its expanding differentiated menu affords both an opportunity to grow the platform utilization within the hospital, as well as protect against competitive threats; and (iii)having a positive effect on defending ourillumigeneC. difficile molecular platform requires no expensive equipment purchase or maintenance contract, which we believe makes it an attractive and affordable option for any size hospital.business.

Foodborne Products

Revenues forfrom our foodborne products (EnterohemorrhagicE. coli(“EHEC”)(EHEC) andCampylobacter), all of which are immunoassay products, totaled $5,700$5,300 during the first quarter of fiscal 2015 third quarter, a 2%2016, an 11% decrease from the fiscal 2014 third quarter. During the nine months ended June 30, 2015 foodborne revenues totaled $18,500, a 10% increase from the fiscal 2014 year-to-date period.first quarter (also 11% in constant-currency). Revenues for our foodborne products on a quarterly basis (up 5% induring the first quarter up 27% in the second quarter and down 2% in the third quarter) have beenof fiscal 2016 were affected by distributor ordering patterns and our inside and field sales programs designed to protect and expand upon our current customer base through the addition of new customers adopting rapid tests and competitive takeaways.patterns. We are continuing to re-emphasize the benefits of increased sensitivity and faster turnaround time versus culture methods in our marketing programs. The primary competition

Page 13


for our foodborne products is laboratory culture methods and an immunoassay EHEC shiga toxin test from one of our competitors. We believe that our test offers better workflow, less hands-on time and quicker results, in addition to being fully compliant with CDC-recommended testing methods. More recently, multi-plex gastro-intestinal panels are introducing new competition in this product category.

H. pylori Products

During the thirdfiscal 2016 first quarter, of fiscal 2015, revenues from ourH. pylori products, all of which are immunoassay products, grew 8%increased 19% (22% in constant-currency) to $8,000. These revenues grew 10% to $23,000 during the first nine months of fiscal 2015. These increases continue$8,700. This increase continues to reflect the benefits of our partnerships with managed care companies in promoting (i) the health and economic benefits of a test and treat strategy; (ii) changes in policies that discourage the use of traditional serology methods and promote the utilization of active infection testing methods; and (iii) physician behavior movement away from serology-based testing and toward direct antigen testing. A significant amount of theH. pylori product revenues are sales to reference labs, whose buying patterns may not be consistent from period to period. In addition to our managed care strategy, we have also begun to increase sales promotions into selected distribution and laboratory channels as a defensive strategy against potential new competitive product introductions later in the year.

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

Respiratory Products

Total respiratory revenues fromfor our Diagnostics segment increased 35%decreased 9% to $5,000$5,600 during the first quarter of fiscal 2016 (decreased 8% in constant-currency). This decline was largely due to the success of promotional “stock-and-block” programs in the third (influenza) and fourth (Group A strep) quarters of fiscal 2015 that affected buying patterns in the first quarter of fiscal 2016.

Women’s Health & STD Products

Revenues from our women’s health & STD products, all of which are molecular products, totaled $1,700 during the first quarter of fiscal 2016, a 7% increase from the fiscal 2015 third quarter; and increased 23% to $17,000 forfirst quarter (also 7% in constant-currency). This growth primarily reflects the nine month year-to-date period. Growth was driven by several products in bothresults of our molecular and immunoassay categories. Our molecular products (commercialization during fiscal 2015 of threeillumigene Group A Strep,illumigenetests for sexually transmitted diseases (Chlamydia, Gonorrhea and HSV). Mycoplasma andillumigene Pertussis) experienced volume growth from new assay placements. Our immunoassay products (influenza and Mycoplasma) experienced growth as a result of increases in Japanese orders of our Mycoplasma product and a large purchase by a distributor of influenza product in advance of the influenza season.

Page 17


Foreign Currency

During the third quarter of fiscal 2015, currency exchange rates had a $1,500 unfavorable impact on revenue; $1,000 unfavorable within the Diagnostics segment and $500 unfavorable within the Life Science segment. On a nine month year-to-date basis, currency exchange rates had a $3,500 unfavorable impact on revenue; $2,500 unfavorable within the Diagnostics segment and $1,000 unfavorable within the Life Science segment.

Significant Customers

Two U.S. distributors accounted for 35%39% and 36%41% of our Diagnostics segment’s total revenues for the thirdfirst quarter of fiscal 2016 and 2015, respectively. These revenues represented 29% and 2014, respectively, and 36% during each of the nine months ended June 30, 2015 and 2014. These distributors represented 27%31% of consolidated revenues for each of the fiscal 2016 and 2015 and 2014 thirdfirst quarters, and 27% and 28% for the fiscal 2015 and 2014 year-to-date nine month periods, respectively.

Within our Life Science segment, two diagnostic manufacturing customers accounted for 16%18% of the segment’s total revenues for each of the thirdfirst quarters of fiscal 2016 and 2015.

Medical Device Tax

On January 1, 2013, the medical device tax established as part of the U.S. health care reform legislation became effective, and as a result, the Company made its first required tax deposit near the end of January 2013. During each of the first quarters of fiscal 2016 and fiscal 2015, 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

Page 14


Statements of Operations. During December 2015, the Consolidations Appropriations Act of 2016 imposed a two-year moratorium on this excise tax effective January 1, 2016. During calendar years 2016 and 2014, and 16% and 17% during the nine months ended June 30, 2015 and 2014, respectively.2017, this moratorium would result in approximately $2,000 of savings each year. We are unable to predict any future legislative changes or developments related to this moratorium or excise tax.

Gross Profit

 

  Three Months Ended June 30, Nine Months Ended June 30,   Three Months Ended December 31, 
  2015 2014 Change 2015 2014 Change   2015 2014 Change 

Gross Profit

  $30,331  $29,242  4 $92,089  $88,842  4  $31,583  $29,237  

Gross Profit Margin

   63 62  +1 point   62 63  -1 point     67  61  +6 points  

The overall gross profit increase for the three months ended December 31, 2015 primarily results from the combined effects of (i) mix of products sold, particularly the higher revenue contribution fromH. pylori products; (ii) realization of manufacturing facility efficiencies for ourillumigene products as a result of bringing in-house certain reagent dispensing operations that were previously outsourced; (iii) manufacturing efficiencies in our Life Science segment; and (iv) favorable effects of currency rates related to products where the purchase cost is denominated in Euros but the customer sales are billed in U.S. dollars.

Our overall operations consist of the sale of diagnostic test kits for various disease states and in alternative test formats, as well as bioresearch reagents, bulk antigens and antibodies, PCR/qPCR reagents, nucleotides, competent cells, proficiency panels, and contract research and development, and contract manufacturing services. Product revenue mix shifts, in the normal course of business, can cause the consolidated gross profit margin to fluctuate by several points.

Due to our growingillumigene platform, we have invested approximately $4,000 in new molecular manufacturing facilities, which will provide additional manufacturing capacity, as well as improved manufacturing efficiency and quality. We believe that we will begin to realize these efficiencies late in fiscal 2015.

Operating Expenses

 

   Three Months Ended June 30, 2015 
   Research &
Development
  Selling &
Marketing
  General &
Administrative
  Total Operating
Expenses
 

2014 Expenses

  $3,146  $  6,249  $  6,715  $16,110 
  

 

 

  

 

 

  

 

 

  

 

 

 

% of Revenues

   7  13  14  34

Fiscal 2015 Increases (Decreases):

     

Diagnostics

   20   (55  (136  (171

Life Science

   48   (10  (44  (6
  

 

 

  

 

 

  

 

 

  

 

 

 

2015 Expenses

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

 

 

  

 

 

  

 

 

  

 

 

 

% of Revenues

   7  13  14  33

% Increase (Decrease)

   2  (1)%   (3)%   (1)% 

   Changes for the Three Months Ended December 31, 2015 
   Research &
Development
  Selling &
Marketing
  General &
Administrative
  Total
Operating
Expenses
 

2015 Expenses

  $3,103  $6,080  $7,385  $16,568 
  

 

 

  

 

 

  

 

 

  

 

 

 

% of Revenues

     13   15   35 

Fiscal 2016 Increases (Decreases):

     

Diagnostics

   395   29   693   1,117 

Life Science

   (117  334   95   312 
  

 

 

  

 

 

  

 

 

  

 

 

 

2016 Expenses

  $3,381  $6,443  $8,173  $17,997 
  

 

 

  

 

 

  

 

 

  

 

 

 

% of Revenues

     14   17   38 

% Increase

       11   

Page 18


   Nine Months Ended June 30, 2015 
   Research &
Development
  Selling &
Marketing
  General &
Administrative
  Total Operating
Expenses
 

2014 Expenses

  $9,185  $18,787  $20,446  $48,418 
  

 

 

  

 

 

  

 

 

  

 

 

 

% of Revenues

   6  13  14  34

Fiscal 2015 Increases (Decreases):

     

Diagnostics

   205   243   753   1,201 

Life Science

   295   (285  (339  (329
  

 

 

  

 

 

  

 

 

  

 

 

 

2015 Expenses

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

 

 

  

 

 

  

 

 

  

 

 

 

% of Revenues

   7  13  14  33

% Increase (Decrease)

   5  —  %    2%     2%  

Overall, totalTotal operating expenses decreased during the third quarter of fiscal 2015 and increased during the first nine monthsquarter of fiscal 2015 relative2016 compared to the comparable priorfirst quarter of fiscal year periods, decreasing slightly as a percentage of both quarterly and year-to-date consolidated revenues. These levels2015. This level of operating expenses result in large partresults primarily from the combined effects of our (i) ongoing efforts to control spending in each of our segments while investing the necessary resources in our strategic areas of growth, including increased investment in new product development in both of our segments,Diagnostics segment, and increased investment in Sales and Marketing personnel and programs, particularly in our DiagnosticsLife Science segment; and (ii) favorable effects of currency rates.

Page 15


Operating expenses for the Diagnostics segment decreased $171increased $1,117 for the thirdfirst quarter of fiscal 20152016 compared to the fiscal 2014 thirdfirst quarter and in the first nine months of fiscal 2015, increased $1,201 over the comparable prior year period.2015. These overall Diagnostics segment increases result largelyprimarily from the combined effects of the following:

Research & Development

Overall increaseIncrease in spending on new product development activities, related primarily to the previously noted products for ourillumigene molecular platform, as well as immunoassay products in development.

Selling & Marketing

Increase in year-to-date personnel costs resulting from increased Sales and Marketing headcount.

General & Administrative

Increase in profit sharingincentive bonus and stock-based compensation expense resulting fromas a result of the previously noted increasesincrease in corporate-wide operating profits, along with an increaseexpenses incurred in legal spending overconnection with completing the prior year related largely to a foreign distributor matter.Company’s investment in Oasis.

Operating Income

Operating income increased 10%7% to $14,398$13,586 for the thirdfirst quarter of fiscal 2015, and increased 6% to $42,799 for the first nine months of fiscal 2015,2016, as a result of the factors discussed above.

Other Income and Expense

First quarter of fiscal 2016 other income and expense included approximately $100 of foreign currency gains. This compares to $600 of foreign currency losses in the first quarter of fiscal 2015, which related primarily to foreign currency exchange transaction losses on a subsidiary intercompany loan.

Income Taxes

The effective rate for income taxes was 36% and 31%remained stable at 35% for the thirdfirst quarters of fiscal 20152016 and 2014, respectively, and 35% and 33% for the nine month year-to-date periods ended June 30, 2015 and 2014, respectively. The higher current year rates relative to fiscal 2014 primarily result from the effects of increased tax apportionments in certain state taxing jurisdictions, as well as the prior year period reflecting the positive effects of a net U.S. foreign tax credit resulting from a restructuring of our legal entities during the fiscal 2014 third quarter.2015. For the fiscal year ending September 30, 2015,2016, we expect the effective tax rate to approximate 35%34%-35%.

Page 19


In September 2013, the Internal Revenue Service issued Treasury Decision 9636, which enacted final tax regulations regarding the capitalization and expensing of amounts paid to acquire, produce or improve tangible property. The regulations also include guidance regarding the retirement of depreciable property. Our adoption of these regulations on October 1, 2014 did not have a significant impact on the Company’s consolidated results of operations, cash flows or financial position.

Liquidity and Capital Resources

Comparative Cash Flow Analysis

Our cash flow and financing requirements are determined by analyses of operating and capital spending budgets, consideration of acquisition plans, and consideration of common share dividends. We have historically maintained a credit facility to augment working capital requirements and to respond quickly to acquisition opportunities. Our investment portfolio presently consists of overnight repurchase agreements.

We have an investment policy that guides the holdings of our investment portfolio.portfolio, which at present consist of overnight repurchase agreements and bank savings accounts. 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.

We do not expect current conditions in the financial markets, or overall economic conditions to have a significant impact on our liquidity needs, financial condition, or results of operations, although no assurances can be made in this regard. We intend to continue to fund our working capital requirements and dividends from current cash flows from operating activities and cash on hand. If needed, we also have an additional source of liquidity through our $30,000 bank credit facility, which has been renewed through April 21, 2018. Approximately $2,000 of our consolidated accounts receivable at June 30, 2015 is due from Italian hospital customers whose funding ultimately comes from the Italian government, which is down from approximately $2,700 at September 30, 2014. The amount of our annual revenues in the country of Greece and the corresponding amount of customer receivables outstanding at any point in time is not significant, and therefore, we do not expect any meaningful impact from the current financial crisis in the country of Greece.facility. Our liquidity needs may change if overall economic conditions worsenchange 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 $31,196$12,092 for the first nine monthsquarter of fiscal 2015,2016, a 32% increase over25% decrease from the $23,611$16,085 provided during the first nine monthsquarter of fiscal 2014.2015. While reflecting the effects of the timing of federal income tax payments, and the timing of payments from and to customers and suppliers, respectively, this $7,585decrease reflects the approximate $3,000 increase results in large part from approximately $5,500 of incentive bonus payments related to fiscal 2013 being made in the first quarter of fiscal 2014, with no such payments having been madeinventory during the fiscalquarter ended December 31, 2015, year-to-date period.compared to the approximate $1,100 decrease in inventory during the quarter ended December 31, 2014. Net cash flows from operating activities and cash on hand are anticipated to be adequate to fund working capital requirements, capital expenditures and dividends during the next 12 months.

Page 16


Capital Resources

We have a $30,000 credit facility with a commercial bank that expires on April 21, 2018. As of JulyJanuary 31, 2015,2016, there were no borrowings outstanding on this facility and we had 100% borrowing capacity available to us. We have had no borrowings outstanding under this facility during the first ninethree months of fiscal 20152016 or during the full year of fiscal 2014.2015.

Our capital expenditures are estimated to berange between approximately $3,000 to $4,000 for fiscal 2015,2016, with the actual amount depending upon actual operating results and the phasing of certain projects. Such expenditures may be funded with cash and equivalents on hand, operating cash flows, and/or availability under the $30,000 credit facility discussed above.

During June 2015, we sold the land and building related to our former Life Science facility in Saco, Maine. Net proceeds from the sale were approximately $1,138.

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

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ITEM 3.QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

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, 2014.2015.

ITEM 4.CONTROLS AND PROCEDURES

ITEM 4. CONTROLS AND PROCEDURES

As of June 30,December 31, 2015, an evaluation was completed under the supervision and with the participation of our management, including our Chief Executive Officer and Chief Financial Officer, of the effectiveness of the design and operation of our disclosure controls and procedures pursuant to Rule 13a-15(b) and 15d-15(b) promulgated under the Securities Exchange Act of 1934, as amended. Based on that evaluation, our management, including the CEO and CFO, concluded that our disclosure controls and procedures were effective as of June 30,December 31, 2015. There have been no changes in our internal control over financial reporting identified in connection with the evaluation of internal control that occurred during the thirdfirst fiscal quarter that havehas materially affected, or areis reasonably likely to materially affect, our internal control over financial reporting, or in other factors that could materially affect internal control subsequent to June  30,December 31, 2015.

Page 17


PART II. OTHER INFORMATION

ITEM 1A. RISK FACTORS

There have been no material changes from risk factors as previously disclosed in the Registrant’s Form 10-K in response to Item 1A to Part I of Form 10-K as updated by the Registrant’s Form 10-Q for the Quarterly Period ended March 31, 2015 in Item 1A to Part II of Form 10-Q.

Page 21


ITEM 6.EXHIBITS

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

 

  10.1ITEM 6. EXHIBITS
Amended and Restated Revolving Note with Fifth Third Bank dated April 21, 2015The following exhibits are being filed or furnished as a part of this Quarterly Report on Form 10-Q.
  10.2Fifth Amendment to Loan and Security Agreement among Meridian Bioscience, Inc., Meridian Bioscience Corporation, Omega Technologies, Inc., Meridian Life Science, Inc., Bioline USA, Inc., and Fifth Third Bank dated April 21, 2015
31.1  Certification of Principal Executive Officer Pursuant to Securities Exchange Act Rule 13a-14(a)/15d-14(a)
31.2  Certification of Principal Financial Officer Pursuant to Securities Exchange Act Rule 13a-14(a)/15d-14(a)
32  Certification of Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
101  The following financial information from Meridian Bioscience Inc.’s Quarterly Report on Form 10-Q for the quarter ended June 30,December 31, 2015 filed with the SEC on August 10, 2015,February 9, 2016, formatted in XBRL includes: (i) Condensed Consolidated Statements of Operations for the three and nine months ended June 30,December 31, 2015 and 2014; (ii) Condensed Consolidated Statements of Comprehensive Income for the three and nine months ended June 30,December 31, 2015 and 2014; (iii) Condensed Consolidated Statements of Cash Flows for the ninethree months ended June 30,December 31, 2015 and 2014; (iv) Condensed Consolidated Balance Sheets as of June 30,December 31, 2015 and September 30, 2014;2015; (v) Condensed Consolidated Statement of Shareholders’ Equity for the ninethree months ended June 30,December 31, 2015; and (vi) the Notes to Condensed Consolidated Financial Statements

 

Page 2218


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:

August 10, 2015

February 9, 2016
  By: 

/s/ Melissa A. Lueke

   Melissa A. Lueke
   

Executive Vice President and Chief Financial Officer

(Principal Financial and Accounting Officer)

 

Page 2319