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MERIDIAN BIOSCIENCE INC - Quarter Report: 2017 March (Form 10-Q)

Form 10-Q
Table of Contents

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

Form 10-Q

 

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

For the Quarterly Period Ended March 31, 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 number 0-14902

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 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  ☒    No  ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-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 Rule 12b-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 April 30, 2017

Common Stock, no par value   42,202,807


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MERIDIAN BIOSCIENCE, INC. AND SUBSIDIARIES

TABLE OF CONTENTS TO QUARTERLY REPORT ON FORM 10-Q

 

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

Financial Statements (Unaudited)

Condensed Consolidated Statements of Operations Three and Six Months Ended March  31, 2017 and 2016

     1  
  

Condensed Consolidated Statements of Comprehensive Income Three and Six Months Ended March 31, 2017 and 2016

     2  
  

Condensed Consolidated Statements of Cash Flows Six Months Ended March 31, 2017 and 2016

     3  
  

Condensed Consolidated Balance Sheets March  31, 2017 and September 30, 2016

     4-5  
  

Condensed Consolidated Statement of Changes in Shareholders’ Equity Six Months Ended March 31, 2017

     6  
  

Notes to Condensed Consolidated Financial Statements

     7-13  
Item 2.    Management’s Discussion and Analysis of Financial Condition and Results of Operations      14-22  
Item 3.    Quantitative and Qualitative Disclosures About Market Risk      22  
Item 4.    Controls and Procedures      22  
PART II.    OTHER INFORMATION   
Item 1A.    Risk Factors      23  
Item 6.    Exhibits      23  
Signature         23  

FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q contains forward-looking statements. The Private Securities Litigation Reform Act of 1995 provides a safe harbor from civil litigation for forward-looking statements accompanied by meaningful cautionary statements. Except for historical information, this report contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, which may be identified by words such as “estimates”, “anticipates”, “projects”, “plans”, “seeks”, “may”, “will”, “expects”, “intends”, “believes”, “should” and similar expressions or the negative versions thereof and which also may be identified by their context. All statements that address operating performance or events or developments that Meridian expects or anticipates will occur in the future, including, but not limited to, statements relating to per share diluted earnings and revenue, are forward-looking statements. Such statements, whether expressed or implied, are based upon current expectations of the Company and speak only as of the date made. Specifically, Meridian’s forward-looking statements are, and will be, based on management’s then-current views and assumptions regarding future events and operating performance. Meridian assumes no obligation to publicly update or revise any forward-looking statements even if experience or future changes make it clear that any projected results expressed or implied therein will not be realized. These statements are subject to various risks, uncertainties and other factors that could cause actual results to differ materially, including, without limitation, the following: Meridian’s continued growth depends, in part, on its ability to introduce into the marketplace enhancements of existing products or new products that incorporate technological advances, meet customer requirements and respond to products developed by Meridian’s competition, and its ability to effectively sell such products. While Meridian has introduced a number of internally developed products, there can be no assurance that it will be successful in the future in introducing such products on a timely basis 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


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


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PART I. FINANCIAL INFORMATION

Item 1. Financial Statements

MERIDIAN BIOSCIENCE, INC. AND SUBSIDIARIES

Condensed Consolidated Statements of Operations (Unaudited)

(in thousands, except per share data)

 

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

NET REVENUES

   $ 54,125     $ 51,259     $ 100,934     $ 98,419  

COST OF SALES

     20,594       17,687       37,953       33,264  
  

 

 

   

 

 

   

 

 

   

 

 

 

GROSS PROFIT

     33,531       33,572       62,981       65,155  
  

 

 

   

 

 

   

 

 

   

 

 

 

OPERATING EXPENSES

        

Research and development

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

Selling and marketing

     8,012       7,210       15,526       13,653  

General and administrative

     7,426       6,875       15,872       14,769  

Acquisition-related costs

     —         1,202       —         1,481  
  

 

 

   

 

 

   

 

 

   

 

 

 

Total operating expenses

     19,345       18,416       38,710       36,413  
  

 

 

   

 

 

   

 

 

   

 

 

 

OPERATING INCOME

     14,186       15,156       24,271       28,742  

OTHER INCOME (EXPENSE)

        

Interest income

     29       3       51       20  

Interest expense

     (408     (43     (831     (43

Other, net

     383       (324     358       (228
  

 

 

   

 

 

   

 

 

   

 

 

 

Total other income (expense)

     4       (364     (422     (251
  

 

 

   

 

 

   

 

 

   

 

 

 

EARNINGS BEFORE INCOME TAXES

     14,190       14,792       23,849       28,491  

INCOME TAX PROVISION

     4,878       5,701       8,258       10,507  
  

 

 

   

 

 

   

 

 

   

 

 

 

NET EARNINGS

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

 

 

   

 

 

   

 

 

   

 

 

 

BASIC EARNINGS PER COMMON SHARE

   $ 0.22     $ 0.22     $ 0.37     $ 0.43  

DILUTED EARNINGS PER COMMON SHARE

   $ 0.22     $ 0.21     $ 0.37     $ 0.42  

WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING - BASIC

     42,202       42,053       42,177       41,984  

EFFECT OF DILUTIVE STOCK OPTIONS AND RESTRICTED SHARE UNITS

     366       372       362       376  
  

 

 

   

 

 

   

 

 

   

 

 

 

WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING - DILUTED

     42,568       42,425       42,539       42,360  
  

 

 

   

 

 

   

 

 

   

 

 

 

ANTI-DILUTIVE SECURITIES:

        

Common share options and restricted share units

     1,001       444       871       476  
  

 

 

   

 

 

   

 

 

   

 

 

 

DIVIDENDS DECLARED PER COMMON SHARE

   $ 0.125     $ 0.20     $ 0.325     $ 0.40  
  

 

 

   

 

 

   

 

 

   

 

 

 

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

 

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MERIDIAN BIOSCIENCE, INC. AND SUBSIDIARIES

Condensed Consolidated Statements of Comprehensive Income (Unaudited)

(in thousands)

 

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

NET EARNINGS

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

Other comprehensive income (loss):

        

Foreign currency translation adjustment

     512       (78     (911     (865

Unrealized gain (loss) on cash flow hedge

     128       (694     1,688       (694

Income taxes related to items of other comprehensive income

     (24     243       (613     243  
  

 

 

   

 

 

   

 

 

   

 

 

 

Other comprehensive income (loss), net of tax

     616       (529     164       (1,316
  

 

 

   

 

 

   

 

 

   

 

 

 

COMPREHENSIVE INCOME

   $ 9,928     $ 8,562     $ 15,755     $ 16,668  
  

 

 

   

 

 

   

 

 

   

 

 

 

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

 

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MERIDIAN BIOSCIENCE, INC. AND SUBSIDIARIES

Condensed Consolidated Statements of Cash Flows (Unaudited)

(in thousands)

 

Six Months Ended March 31,

   2017     2016  

CASH FLOWS FROM OPERATING ACTIVITIES

    

Net earnings

   $ 15,591     $ 17,984  

Non-cash items included in net earnings:

    

Depreciation of property, plant and equipment

     2,154       1,785  

Amortization of intangible assets

     1,904       762  

Amortization of deferred instrument costs

     500       544  

Stock-based compensation

     2,360       2,290  

Deferred income taxes

     1,982       (306

Losses on long-lived assets

     —         659  

Change in current assets, net of acquisition

     4,634       (6,905

Change in current liabilities, net of acquisition

     (3,269     1,505  

Other, net

     (724     143  
  

 

 

   

 

 

 

Net cash provided by operating activities

     25,132       18,461  
  

 

 

   

 

 

 

CASH FLOWS FROM INVESTING ACTIVITIES

    

Purchase of property, plant and equipment

     (2,273     (1,524

Purchase of equity method investment

     —         (600

Acquisition of Magellan, net of cash acquired

     —         (62,177

Purchase of intangibles and other assets

     —         (16
  

 

 

   

 

 

 

Net cash used for investing activities

     (2,273     (64,317
  

 

 

   

 

 

 

CASH FLOWS FROM FINANCING ACTIVITIES

    

Dividends paid

     (13,715     (16,817

Proceeds from term loan, net of issuance costs

     —         59,842  

Payments on term loan

     (1,500     —    

Proceeds and tax benefits from exercises of stock options

     303       1,969  
  

 

 

   

 

 

 

Net cash (used for) provided by financing activities

     (14,912     44,994  
  

 

 

   

 

 

 

Effect of Exchange Rate Changes on Cash and Equivalents

     (428     (165
  

 

 

   

 

 

 

Net Increase (Decrease) in Cash and Equivalents

     7,519       (1,027

Cash and Equivalents at Beginning of Period

     47,226       49,973  
  

 

 

   

 

 

 

Cash and Equivalents at End of Period

   $ 54,745     $ 48,946  
  

 

 

   

 

 

 

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

 

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MERIDIAN BIOSCIENCE, INC. AND SUBSIDIARIES

Condensed Consolidated Balance Sheets

(in thousands)

ASSETS

 

     March 31,
2017
(Unaudited)
     September 30,
2016
 
       
       

CURRENT ASSETS

     

Cash and equivalents

   $ 54,745      $ 47,226  

Accounts receivable, less allowances of $381 and $334

     26,980        27,102  

Inventories

     42,375        45,057  

Prepaid expenses and other current assets

     4,694        7,406  
  

 

 

    

 

 

 

Total current assets

     128,794        126,791  
  

 

 

    

 

 

 

PROPERTY, PLANT AND EQUIPMENT, at Cost

     

Land

     1,149        1,155  

Buildings and improvements

     31,800        31,487  

Machinery, equipment and furniture

     46,521        45,085  

Construction in progress

     1,784        1,947  
  

 

 

    

 

 

 

Subtotal

     81,254        79,674  

Less: accumulated depreciation and amortization

     51,078        49,224  
  

 

 

    

 

 

 

Net property, plant and equipment

     30,176        30,450  
  

 

 

    

 

 

 

OTHER ASSETS

     

Goodwill

     60,836        61,982  

Other intangible assets, net

     28,457        29,855  

Restricted cash

     1,000        1,000  

Deferred instrument costs, net

     1,291        1,392  

Fair value of interest rate swap

     960        —    

Other assets

     388        353  
  

 

 

    

 

 

 

Total other assets

     92,932        94,582  
  

 

 

    

 

 

 

TOTAL ASSETS

   $ 251,902      $ 251,823  
  

 

 

    

 

 

 

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

 

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MERIDIAN BIOSCIENCE, INC. AND SUBSIDIARIES

Condensed Consolidated Balance Sheets

(dollars in thousands)

LIABILITIES AND SHAREHOLDERS’ EQUITY

 

     March 31,
2017
(Unaudited)
    September 30,
2016
 

CURRENT LIABILITIES

    

Accounts payable

   $ 6,416     $ 7,627  

Accrued employee compensation costs

     4,082       7,106  

Current portion of acquisition consideration

     653       —    

Other accrued expenses

     2,531       2,606  

Current portion of long-term debt

     4,500       3,750  

Income taxes payable

     1,716       1,482  
  

 

 

   

 

 

 

Total current liabilities

     19,898       22,571  
  

 

 

   

 

 

 

NON-CURRENT LIABILITIES

    

Acquisition consideration

     1,730       2,383  

Post-employment benefits

     2,362       2,305  

Fair value of interest rate swap

     —         729  

Long-term debt

     52,379       54,610  

Deferred income taxes

     4,705       2,753  
  

 

 

   

 

 

 

Total non-current liabilities

     61,176       62,780  
  

 

 

   

 

 

 

COMMITMENTS AND CONTINGENCIES

    

SHAREHOLDERS’ EQUITY

    

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

     —         —    

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

     —         —    

Additional paid-in capital

     124,672       122,356  

Retained earnings

     51,508       49,632  

Accumulated other comprehensive loss

     (5,352     (5,516
  

 

 

   

 

 

 

Total shareholders’ equity

     170,828       166,472  
  

 

 

   

 

 

 

TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY

   $ 251,902     $ 251,823  
  

 

 

   

 

 

 

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

 

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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
 

Balance at September 30, 2016

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

Cash dividends paid

     —          —         (13,715     —         (13,715

Exercise of stock options

     18        (44     —         —         (44

Conversion of restricted share units

     77        —         —         —         —    

Stock compensation expense

     —          2,360       —         —         2,360  

Net earnings

     —          —         15,591       —         15,591  

Foreign currency translation adjustment

     —          —         —         (911     (911

Hedging activity, net of tax

     —          —         —         1,075       1,075  
  

 

 

    

 

 

   

 

 

   

 

 

   

 

 

 

Balance at March 31, 2017

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

 

 

    

 

 

   

 

 

   

 

 

   

 

 

 

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

 

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MERIDIAN BIOSCIENCE, INC. AND SUBSIDIARIES

Notes to Condensed Consolidated Financial Statements

Dollars in Thousands, Except Per Share Amounts

(Unaudited)

 

1. Basis of Presentation

The interim condensed consolidated financial statements are unaudited and are prepared in accordance with accounting principles generally accepted in the United States of America for interim financial information, and the rules and regulations of the Securities and Exchange Commission. Certain information and footnote disclosures normally included in financial statements prepared in accordance with generally accepted accounting principles have been condensed or omitted pursuant to such rules and regulations. In the opinion of Management, the interim financial statements include all normal adjustments and disclosures necessary to present fairly the Company’s financial position as of March 31, 2017, the results of its operations for the three and six month periods ended March 31, 2017 and 2016, and its cash flows for the six month periods ended March 31, 2017 and 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 Form 10-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 Form 10-K.

Recent Accounting Pronouncements –

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

In February 2016, the FASB issued ASU 2016-02, Leases, which amends the accounting guidance related to leases. These changes, which are designed to increase transparency and comparability among organizations for both lessees and lessors, include, among other things, requiring recognition of lease assets and liabilities on the balance sheet and disclosing key information about leasing arrangements. Adoption and implementation of the guidance is not required by the Company until the beginning of fiscal 2020, although early adoption is permitted. The Company expects to begin its assessment of the impact that adoption of this guidance will have on its financial statements in fiscal 2018.

In March 2016, the FASB issued ASU 2016-09, Improvements to Employee Share-Based Payment Accounting, which amends the accounting for share-based payment transactions. These changes, which are designed for simplification, involve several aspects of the accounting for share-based transactions, including the income tax consequences, classification of awards as either equity or liabilities, and classification on the statement of cash flows. Adoption and implementation of the guidance is not required by the Company until the beginning of fiscal 2018, although early adoption is permitted. The Company has assessed 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 tax returns. The tax effect of such differences is currently recorded in additional paid-in capital and reflected within the financing activities section of the statement of cash flows but upon adoption of this guidance will be required to be recorded directly to income tax expense and reflected within the operating activities section of the statement of cash flows. While the impact of this guidance, which the Company plans to adopt on a prospective

 

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

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

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

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

 

3. Acquisition of Magellan

On March 24, 2016, we acquired all of the outstanding common stock of Magellan Biosciences, Inc., and its wholly-owned subsidiary Magellan Diagnostics, Inc. (collectively, “Magellan”), for $67,874, utilizing the proceeds from a $60,000 five-year term loan and cash and equivalents on hand. An amount of the acquisition consideration totaling $2,383 remains payable to the sellers, pending the realization of tax benefits for certain net operating loss carryforwards in future tax returns. Headquartered near Boston, Massachusetts, Magellan is a leading manufacturer of FDA-cleared products for the testing of blood to diagnose lead poisoning in children and adults. Magellan is the leading provider of point-of-care lead testing systems in the U.S.

Since the consideration paid exceeded the fair value of the net assets acquired, goodwill in the amount of $40,591 was recorded in connection with this acquisition, none of which will be deductible for tax purposes. This goodwill results largely from the addition of Magellan’s complementary customer base and distribution channels, industry reputation in the U.S. as a leader in lead testing, and management talent and workforce. Our Condensed Consolidated Statements of Operations for the three and six months ended March 31, 2016 include $1,105 of transaction costs related to the Magellan acquisition, which are reflected as Operating Expenses.

The Magellan results of operations, which are included in our Condensed Consolidated Statements of Operations for the three and six months ended March 31, 2017 and reported as part of the Diagnostics operating segment, include $675 and $1,387, respectively, of general and administrative expenses 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.

 

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The results of Magellan included in the Company’s consolidated results for the three and six months ended March 31, 2017 are as follows, reflecting the items noted above and excluding interest expense on the debt secured by Meridian in connection with the transaction:

 

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

Net Revenues

   $ 3,645      $ 8,844  

Net Earnings

   $ (280    $ 188  

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

 

     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  

Accounts receivable

     1,700        —          1,700  

Inventories

     1,400        —          1,400  

Other current assets

     300        —          300  

Property, plant and equipment

     2,800        (200      2,600  

Goodwill

     42,800        (2,200      40,600  

Other intangible assets (estimated useful life):

        

Customer relationships (15 years)

     12,600        300        12,900  

Technology (10 years)

     10,600        300        10,900  

Non-compete agreements (2 years)

     700        —          700  

Trade names (approximate 9 year weighted average)

     3,700        (700      3,000  
  

 

 

    

 

 

    

 

 

 
     80,000        (2,500      77,500  

Fair value of liabilities assumed -

        

Accounts payable and accrued expenses

     1,600        100        1,700  

Deferred income tax liabilities

     10,600        (2,700      7,900  
  

 

 

    

 

 

    

 

 

 

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

   $ 67,800      $ 100      $ 67,900  
  

 

 

    

 

 

    

 

 

 

 

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

 

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

Net Revenues

   $ 54,125      $ 54,962      $ 100,934      $ 106,057  

Net Earnings

   $ 9,312      $ 9,297      $ 15,591      $ 17,856  

These pro forma amounts have been calculated by including the results of Magellan, and adjusting the combined results to give effect to the following, as if the acquisition had been consummated on October 1, 2015, together with the consequential tax effects thereon:

 

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

 

  (ii) reflect the additional depreciation and amortization that would have been charged in connection with the fair value adjustments to inventory, property, plant and equipment, and identifiable intangible assets ($688 and $1,556 in the three and six months ended March 31, 2016, respectively);

 

  (iii) reflect equity-based awards granted under the Company’s 2012 Stock Incentive Plan to certain Magellan employees in accordance with executed employment agreements, and to certain Meridian employees to reward them for their efforts in connection with the transaction ($44 and $90 in the three and six months ended March 31, 2016, respectively); and

 

  (iv) reflect the interest expense that would have been incurred on the Company’s $60,000 term note ($423 and $852 in the three and six months ended March 31, 2016, respectively).

 

4. Cash and Equivalents

Cash and equivalents include the following components:

 

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

Overnight repurchase agreements

   $ 8,839      $ —        $ 9,988      $ —    

Institutional money market funds

     20,024        —          10,020        —    

Cash on hand -

           

Restricted

     —          1,000        —          1,000  

Unrestricted

     25,882        —          27,218        —    
  

 

 

    

 

 

    

 

 

    

 

 

 

Total

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

 

 

    

 

 

    

 

 

    

 

 

 

 

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5. Inventories

Inventories are comprised of the following:

 

     March 31,
2017
     September 30,
2016
 

Raw materials

   $ 7,192      $ 7,639  

Work-in-process

     12,890        13,146  

Finished goods - instruments

     1,858        2,378  

Finished goods - kits and reagents

     20,435        21,894  
  

 

 

    

 

 

 

Total

   $ 42,375      $ 45,057  
  

 

 

    

 

 

 

 

6. Intangible Assets

A summary of our acquired intangible assets subject to amortization, as of March 31, 2017 and September 30, 2016, is as follows:

 

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

Manufacturing technologies, core products and cell lines

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

Trade names, licenses and patents

     8,584        3,874        9,037        3,947  

Customer lists, customer relationships and supply agreements

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

Non-compete agreements

     720        360        680        170  
  

 

 

    

 

 

    

 

 

    

 

 

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

 

 

    

 

 

    

 

 

    

 

 

 

The actual aggregate amortization expense for these intangible assets was $936 and $374 for the three months ended March 31, 2017 and 2016, respectively, and $1,904 and $762 for the six months ended March 31, 2017 and 2016, respectively. The estimated aggregate amortization expense for these intangible assets for each of the fiscal years through fiscal 2022 is as follows: remainder of fiscal 2017 – $1,866, fiscal 2018 – $3,529, fiscal 2019 – $3,308, fiscal 2020 – $3,148, fiscal 2021 – $2,560, and fiscal 2022 – $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 – $2,250, fiscal 2018 – $4,500, fiscal 2019 – $5,250, fiscal 2020 – $6,000, and fiscal 2021 – $39,000. In light of the term loan’s interest being determined on a variable rate basis, the fair value of the term loan at March 31, 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 was established with critical terms identical to those of the term loan, including (i) notional reduction amounts and dates; (ii) LIBOR settlement rates;

 

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(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 March 31, 2017, the fair value of the interest rate swap was an asset of $960, and is reflected as a non-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 maintains 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 March 31, 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 March 31, 2017, the Company is in compliance with all covenants. The Company is also required to maintain a cash compensating balance with the bank in the amount of $1,000, and is in compliance with this requirement.

 

8. Reportable Segments and Major Customers

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 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 organizations in the life science and agri-bio industries engaged in research, and by other diagnostics 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.

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, plant genotyping, and mutation detection, among others).

Amounts due from two Diagnostics distributor customers accounted for 15% and 16% of consolidated accounts receivable at March 31, 2017 and September 30, 2016, respectively. Revenues from these two distributor customers accounted for 33% and 26% of the Diagnostics segment third-party revenues during the three months ended March 31, 2017 and 2016, respectively, and 28% and 33% during the six months ended March 31, 2017 and 2016, respectively. These distributors represented 23% and 19% of consolidated revenues for the fiscal 2017 and 2016 second quarters, respectively, and 20% and 24% for the respective year-to-date six month periods.

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

 

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Segment information for the interim periods is as follows:

 

     Diagnostics      Life Science      Eliminations (1)      Total  

Three Months Ended March 31, 2017

 

Net revenues -

           

Third-party

   $ 37,772      $ 16,353      $ —        $ 54,125  

Inter-segment

     128        107        (235      —    

Operating income

     9,595        4,571        20        14,186  

Goodwill (March 31, 2017)

     41,841        18,995        —          60,836  

Other intangible assets, net (March 31, 2017)

     26,516        1,941        —          28,457  

Total assets (March 31, 2017)

     185,094        66,894        (86      251,902  

Three Months Ended March 31, 2016

 

Net revenues -

           

Third-party

   $ 37,354      $ 13,905      $ —        $ 51,259  

Inter-segment

     84        387        (471      —    

Operating income

     11,196        4,154        (194      15,156  

Goodwill (September 30, 2016)

     42,608        19,374        —          61,982  

Other intangible assets, net (September 30, 2016)

     27,534        2,321        —          29,855  

Total assets (September 30, 2016)

     185,241        66,624        (42      251,823  

Six Months Ended March 31, 2017

 

Net revenues -

           

Third-party

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

Inter-segment

     207        232        (439      —    

Operating income

     16,238        7,838        195        24,271  

Six Months Ended March 31, 2016

 

Net revenues -

           

Third-party

   $ 72,655      $ 25,764      $ —        $ 98,419  

Inter-segment

     155        754        (909      —    

Operating income

     21,526        7,390        (174      28,742  

 

(1) Eliminations consist of inter-segment transactions.

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

 

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

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

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

RESULTS OF OPERATIONS

Quarterly Overview

The second quarter of fiscal 2017 was characterized by improvement in the Company’s overall results compared to those of the first quarter, with both our Diagnostics and Life Science reportable segments reflecting revenue increases over both the fiscal 2017 first quarter and the comparable fiscal 2016 second quarter. These improvements reflect the benefits of measures taken since late in fiscal 2016 to stabilize our Americas core diagnostics business, including making changes to our senior management team and strengthening our relationships with key distribution partners, as well as actions taken to align resources, reduce expenses and optimize investments in product development. Revenues for the second quarter of fiscal 2017 were 16% higher than the first quarter. Similarly, net earnings for the second quarter of fiscal 2017 were 48% higher than the first quarter.

Three Months Ended March 31, 2017

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

Revenues for the Diagnostics segment for the second quarter of fiscal 2017 increased 1% compared to the second quarter of fiscal 2016 (increased 2% on a constant-currency basis), comprised of a 2% decrease in molecular products and a 2% increase in non-molecular products, including $3,645 of Magellan revenues. With a 25% increase in its immunoassay components business and a 4% increase in its molecular components business, revenues of our Life Science segment increased by 18% during the second quarter of fiscal 2017 compared to the second quarter of fiscal 2016 (increasing 20% on a constant-currency basis).

Six Months Ended March 31, 2017

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

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

 

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USE OF NON-GAAP MEASURES

We have supplemented our reported GAAP financial information with information on net earnings, basic earnings per share and diluted earnings per share, excluding the effect of costs associated with acquisition activity, each of which is a non-GAAP financial measure, as well as reconciliations to amounts reported under U.S. Generally Accepted Accounting Principles. We believe that this information is useful to those who read our financial statements and evaluate our operating results because:

 

  1) These measures help to appropriately evaluate and compare the results of operations from period to period by removing the impact of non-routine costs related to acquisition activity; and

 

  2) These measures are used by our management for various purposes, including evaluating performance against incentive bonus achievement targets, comparing performance from period to period in presentations to our board of directors, and as a basis for strategic planning and forecasting.

 

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

Net Earnings -

           

U.S. GAAP basis

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

Acquisition-related costs (1)

     —          1,000        —          1,233  
  

 

 

    

 

 

    

 

 

    

 

 

 

Adjusted earnings

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

 

 

    

 

 

    

 

 

    

 

 

 

Net Earnings per Basic Common Share -

           

U.S. GAAP basis

   $ 0.22      $ 0.22      $ 0.37      $ 0.43  

Acquisition-related costs (1)

     —          0.02        —          0.03  
  

 

 

    

 

 

    

 

 

    

 

 

 

Adjusted Basic EPS

   $ 0.22      $ 0.24      $ 0.37      $ 0.46  
  

 

 

    

 

 

    

 

 

    

 

 

 

Net Earnings per Diluted Common Share -

           

U.S. GAAP basis

   $ 0.22      $ 0.21      $ 0.37      $ 0.42  

Acquisition-related costs (1)

     —          0.02        —          0.03  
  

 

 

    

 

 

    

 

 

    

 

 

 

Adjusted Diluted EPS (2)

   $ 0.22      $ 0.24      $ 0.37      $ 0.45  
  

 

 

    

 

 

    

 

 

    

 

 

 

 

(1) Acquisition-related costs are net of income tax effects of $202 and $248 for the three and six month periods, respectively, which were calculated using the effective tax rates of the jurisdictions in which the costs were incurred.

 

(2) Net Earnings per Diluted Common Share for the three months ended March 31, 2016 does not sum to the total due to rounding.

These non-GAAP measures may be different from non-GAAP measures used by other companies. In addition, these non-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.

 

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

Diagnostics -

            

Americas

   $ 31,842     $ 31,864       —     $ 59,411     $ 61,979       (4 )% 

EMEA

     5,013       4,882       3     10,675       9,531       12

ROW

     917       608       51     1,494       1,145       30
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total Diagnostics

     37,772       37,354       1     71,580       72,655       (1 )% 
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Life Science -

            

Americas

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

EMEA

     6,722       4,614       46     11,620       9,150       27

ROW

     3,899       2,935       33     6,603       5,155       28
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total Life Science

     16,353       13,905       18     29,354       25,764       14
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Consolidated

   $ 54,125     $ 51,259       6   $ 100,934     $ 98,419       3
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

% of total revenues -

            

Diagnostics

     70     73       71     74  

Life Science

     30     27       29     26  
  

 

 

   

 

 

     

 

 

   

 

 

   

Total

     100     100       100     100  
  

 

 

   

 

 

     

 

 

   

 

 

   

Ex-Americas

     31     25       30     25  
  

 

 

   

 

 

     

 

 

   

 

 

   

 

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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 our illumigene platform

 

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

Life Science

 

  1) Molecular components

 

  2) Immunoassay components

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

 

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

Diagnostics -

            

Molecular

   $ 9,477     $ 9,665       (2 )%    $ 17,188     $ 19,501       (12 )% 

Non-molecular

     28,295       27,689       2     54,392       53,154       2
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total Diagnostics

   $ 37,772     $ 37,354       1   $ 71,580     $ 72,655       (1 )% 
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Life Science -

            

Molecular components

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

Immunoassay components

     11,014       8,789       25     18,899       15,899       19
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total Life Science

   $ 16,353     $ 13,905       18   $ 29,354     $ 25,764       14
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

% of Diagnostics revenues -

            

Molecular

     25     26       24     27  

Non-molecular

     75     74       76     73  
  

 

 

   

 

 

     

 

 

   

 

 

   

Total Diagnostics

     100     100       100     100  
  

 

 

   

 

 

     

 

 

   

 

 

   

% of Life Science revenues -

            

Molecular components

     33     37       36     38  

Immunoassay components

     67     63       64     62  
  

 

 

   

 

 

     

 

 

   

 

 

   

Total Life Science

     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 our illumigene molecular platform of products decreased 2% to $9,477 for the second quarter of fiscal 2017 (also 2% on a constant-currency basis), and decreased 12% to $17,188 for the six month year-to-date period (also 12% on a constant-currency basis). This decrease reflects the ongoing increased competition within the molecular-based testing market, most notably within the market for C. difficile testing.

We have nearly 1,550 customer account placements. Of these account placements, over 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 approximately 475 accounts that are regularly purchasing, evaluating and/or validating two or more assays. Increasing the number of customers utilizing two or more assays is a key objective, as we believe broader menu utilization lessens the risk of displacement by competitors.

 

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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. Our illumigene Malaria test has been placed in nearly 100 accounts in the EMEA region for use as a screening test for travelers returning to Europe from endemic areas in Africa. We have initiated efforts to develop market channels in the endemic areas of Africa, and early results are encouraging.

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. During the second quarter of fiscal 2017 we experienced 5% growth in all testing categories, other than the hyper-competitive C. difficile arena and 6% growth during the six month year-to-date period. While this market is competitive, with molecular companies such as Cepheid and Becton Dickinson, and others such as Quidel, Great Basin, Nanosphere and Alere, we believe we are well-positioned. 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 the illumigene assays, make illumigene 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’s non-molecular products increased 2% in both the second quarter of fiscal 2017 and on a six month year-to-date basis. These results reflect the addition of Magellan’s revenue, largely offset by decreased revenues in our H. pylori and other immunoassay product lines.

Revenues from Magellan’s sales of products to test for elevated levels of lead in blood totaled $3,645 and $8,844 during the second quarter of fiscal 2017 and the six month year-to-date period, respectively. Compared to the three-month and six-month periods ended March 31, 2016, which were prior to Meridian’s ownership of Magellan, these revenues were approximately flat and up approximately 17%, respectively. Magellan’s revenues for the second quarter of fiscal 2017 were adversely affected by distributor and international order patterns. Also, during the second quarter, Magellan executed distribution agreements with distributors in China and Kenya that are expected to contribute revenues during the second half of fiscal 2017.

During the second quarter of fiscal 2017, revenues from our H. pylori products decreased 7% (6% on a constant-currency basis) to $7,725. These revenues decreased 13% to $14,881 during the first six months of fiscal 2017 (12% on a constant-currency basis). In fiscal 2016, we employed bulk-buy sales programs (also referred to as “stock-and-block” programs) intended to increase major customer inventory levels as a defense against potential competitors upon the expiration of our patent, as further described below. Although certain participating customers are continuing to consume the inventory purchased as part of these programs, we expect our H. pylori revenue to return to flat to low single-digit growth during the second half of fiscal 2017. This growth expectation reflects customers working through this inventory and replenishing product, and our realizing volume growth from the ongoing conversion of serology testing to our antigen tests. We continue to believe there are ongoing benefits to be realized from our partnerships with managed care companies in promoting: (i) the health and economic benefits of a test and treat strategy; (ii) changes in policies that discourage the use of traditional serology methods and promote the utilization of active infection testing methods; and (iii) physician behavior of movement away from serology-based testing and toward direct antigen testing. A significant amount of the H. 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 treat H. pylori. We believe that partnering the ability to diagnose H. pylori and identify resistance is a strong competitive advantage.

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

 

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During the second quarter of fiscal 2017, revenues from our other immunoassay products (including C. difficile, foodborne and respiratory) decreased 14% (also 14% on a constant-currency basis) to $15,922. These revenues decreased 16% to $29,537 during the first six months of fiscal 2017 (also 16% on a constant-currency basis). These decreases result primarily from the effects of continued increased competition and distributor order patterns.

Life Science Products

During the second quarter of fiscal 2017, revenues from our Life Science segment increased 18%, with revenues from molecular component sales increasing 4% from the comparable fiscal 2016 quarter and revenues from immunoassay component sales increasing 25%. For the first six months of fiscal 2017, revenues from our Life Science segment increased 14%, with revenues from molecular component sales increasing 6% from the year-to-date fiscal 2016 period and revenues from immunoassay component sales increasing 19%. Our molecular component business’ growth was negatively impacted by the movement in currency exchange rates since the fiscal 2016 periods, with revenues increasing 10% and 12% on a constant-currency basis over the second quarter and first six months of fiscal 2016, respectively. Our Life Science segment continued to benefit from increased sales into China, with such sales totaling approximately $1,300 during the second quarter of fiscal 2017 (approximately $200 in the molecular components business and $1,100 in the immunoassay components business) and approximately $2,000 during the year-to-date period (approximately $400 in the molecular components business and $1,600 in the immunoassay components business) New products also contributed to growth, including EPIK™ miRNA Select, JetSeq™, SensiFast™ Lyo-Ready, and MIC Personal qPCR Cycler and accessories.

Significant Customers

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

Medical Device Tax

During the first three months of fiscal 2016, the Company recorded approximately $500 of medical device tax expense, which is reflected as a component of cost of sales in the accompanying Condensed Consolidated Statements of Operations. During December 2015, the Consolidations Appropriations Act of 2016 imposed a two-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 March 31,     Six Months Ended March 31,  
     2017     2016     Change     2017     2016     Change  

Gross Profit

   $ 33,531     $ 33,572       —     $ 62,981     $ 65,155       (3 )% 

Gross Profit Margin

     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 margin H. pylori products; (ii) customer mix; (iii) operating segment mix; and (iv) decreased production levels in certain of our production facilities.

 

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Operating Expenses

 

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

2016 Expenses

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

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

% of Revenues

     6     14     13     2     36

Fiscal 2017 Increases (Decreases):

 

Diagnostics

     865       654       842       (1,202     1,159  

Life Science

     (87     148       (291     —         (230
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

2017 Expenses

   $ 3,907     $ 8,012     $ 7,426     $ —       $ 19,345  
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

% of Revenues

     7     15     14     —       36

% Increase (Decrease)

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

2016 Expenses

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

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

% of Revenues

     7     14     15     2     37

Fiscal 2017 Increases (Decreases):

 

Diagnostics

     925       1,596       1,627       (1,481     2,667  

Life Science

     (123     277       (524     —         (370
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

2017 Expenses

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

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

% of Revenues

     7     15     16     —       38

% Increase (Decrease)

     12     14     7     (100 )%      6

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

Operating Income

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

Income Taxes

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

 

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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.

Following the release of results for the fiscal 2017 first quarter, the Board of Directors 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. This action, as well as the declaration of a $0.125 per share cash dividend for the second quarter, serves to bring the annual dividend rate more in line with our long-standing policy of establishing a cash dividend payout ratio of between 75% and 85% of diluted earnings per 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.

Following its June 23, 2016 vote to leave the European Union (commonly referred to as “Brexit”), on March 29, 2017, the United Kingdom invoked Article 50 of the Lisbon Treaty; thus formally commencing the process of exiting the European Union. While the impact of Brexit remains uncertain, the resulting immediate changes in foreign currency exchange rates have had a limited overall impact due to natural hedging. However, any predicted deterioration in the United Kingdom and European economic outlook may have an adverse effect on revenue growth, but the extent of such effect cannot yet be quantified. In the longer term, it is possible that we will be directly impacted in a number of key areas including the hiring and retention of qualified staff, regulatory affairs, manufacturing and logistics. We are closely monitoring the Brexit developments in order to determine, quantify and proactively address changes as they become clear. Despite the Brexit developments, we do not expect macroeconomic conditions to have a significant impact on our liquidity needs, financial condition or results of operations, although no assurances can be made in this regard. We intend to continue to fund our working capital requirements and dividends from current cash flows from operating activities and cash on hand. If needed, we also have an additional source of liquidity through our $30,000 bank revolving credit facility. Our liquidity needs may change if overall economic conditions worsen and/or liquidity and credit within the financial markets tightens for an extended period of time, and such conditions impact the collectibility of our customer accounts receivable or impact credit terms with our vendors, or disrupt the supply of raw materials and services.

Net cash provided by operating activities totaled $25,132 for the first six months of fiscal 2017, a 36% increase from the $18,461 provided during the first six 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 year-to-date fiscal 2017 period, compared to increased levels during the year-to-date fiscal 2016 period; and (ii) decreased accrued employee compensation costs during the first six months of fiscal 2017, reflecting the payment of discretionary bonuses related to fiscal 2016. Net cash flows from operating activities and cash on hand are anticipated to be adequate to fund working capital requirements, capital expenditures and dividends at the previously-noted reduced rate during the next 12 months.

As described in Notes 3 and 7 of the accompanying Condensed Consolidated Financial Statements, on March 24, 2016, the Company acquired all of the outstanding common stock of Magellan for $67,874, utilizing the proceeds from a $60,000 five-year term loan and cash and equivalents on hand. An amount of the acquisition consideration totaling $2,383 remains payable to the sellers, pending the realization of tax benefits for certain net operating loss carryforwards in future tax returns.

 

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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 April 30, 2017, there were no borrowings outstanding on this facility and we had 100% borrowing capacity available to us. We have had no borrowings outstanding under this revolving credit facility during the first six months of fiscal 2017 or during the full year of fiscal 2016.

Our capital expenditures are estimated to range between approximately $3,000 to $5,000 for fiscal 2017, with the actual amount dependent upon actual operating results and the phasing of certain projects. Such expenditures may be funded with cash and equivalents on hand, operating cash flows, and/or availability under the $30,000 revolving credit facility discussed above.

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

ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

There have been no material changes in the Company’s exposure to market risk since September 30, 2016.

ITEM 4. CONTROLS AND PROCEDURES

As of March 31, 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 13a-15(b) and 15d-15(b) promulgated under the Securities Exchange Act of 1934, as amended. Based on that evaluation, our management, including the CEO and CFO, concluded that our disclosure controls and procedures were effective as of March 31, 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 second fiscal quarter that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting, or in other factors that could materially affect internal control subsequent to March 31, 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.

 

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PART II. OTHER INFORMATION

ITEM 1A. RISK FACTORS

There have been no material changes from risk factors as previously disclosed in the Registrant’s Form 10-K in response to Item 1A to Part I of Form 10-K.

ITEM 6. EXHIBITS

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

 

  31.1    Certification of Principal Executive Officer Pursuant to Securities Exchange Act Rule 13a-14(a)/15d-14(a)
  31.2    Certification of Principal Financial Officer Pursuant to Securities Exchange Act Rule 13a-14(a)/15d-14(a)
  32    Certification of Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
101    The following financial information from Meridian Bioscience Inc.’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2017 filed with the SEC on May 10, 2017, formatted in XBRL includes: (i) Condensed Consolidated Statements of Operations for the three and six months ended March 31, 2017 and 2016; (ii) Condensed Consolidated Statements of Comprehensive Income for the three and six months ended March 31, 2017 and 2016; (iii) Condensed Consolidated Statements of Cash Flows for the six months ended March 31, 2017 and 2016; (iv) Condensed Consolidated Balance Sheets as of March 31, 2017 and September 30, 2016; (v) Condensed Consolidated Statement of Shareholders’ Equity for the six months ended March 31, 2017; and (vi) the Notes to Condensed Consolidated Financial Statements

SIGNATURE

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

 

    MERIDIAN BIOSCIENCE, INC.
Date: May 10, 2017   By:    

/s/ Melissa A. Lueke

    Melissa A. Lueke
   

Executive Vice President and Chief Financial Officer

(Principal Financial and Accounting Officer)

 

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