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, 2019

2020

OR

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

For the transition period from
to

Commission filenumber    
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

Securities registered pursuant to Section 12(b) of the Act:
Title of each class
Trading
Symbol(s)
Name of each exchange
on which registered
Common Stock, no par value
VIVO
NASDAQ Global Select Market
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 every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation
S-T
232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit 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
 
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  ☒

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading

Symbol(s)

Name of each exchange

on which registered

Common Stock, no par valueVIVONASDAQ Global Select Market

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

Class

 

Class
Outstanding April 30, 2019

2020
Common Stock, no par value
 42,628,582
42,832,859


Table of Contents

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 “continues”, “estimates”, “anticipates”, “projects”, “plans”, “seeks”, “may”, “will”, “expects”, “intends”, “believes”, “signals”, “should”, “can” 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, sales, product demand, revenue and revenue,the impact of
COVID-19
on our business and prospects, are forward-looking statements. Such statements, whether expressed or implied, are based upon current expectations of the Company and speak only as of the date made. Specifically, Meridian’s forward-looking statements are, and will be, based on management’s then-current views and assumptions regarding future events and operating performance. Meridian assumes no obligation to publicly update or revise any forward-looking statements even if experience or future changes make it clear that any projected results expressed or implied therein will not be realized. These statements are subject to various risks, uncertainties and other factors that could cause actual results to differ materially, including, without limitation, the following:
Meridian’s operating results, financial condition and continued growth depends, in part, on its ability to introduce into the marketplace enhancements of existing products or new products that incorporate technological advances, meet customer requirements and respond to products developed by Meridian’s competition, its ability to effectively sell such products and its ability to successfully expand and effectively manage increased sales and marketing operations. While Meridian has introduced a number of internally developed products and acquired 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, and unexpected or costly manufacturing costs associated with its introduction of new products or acquired products could cause actual results to differ from expectations. Meridian relies on proprietary, patented and licensed technologies. As such, the Company’s ability to protect its intellectual property rights, as well as the potential for intellectual property litigation, would impact its results. Ongoing consolidations of reference laboratories and formation of multi-hospital alliances may cause adverse changes to pricing and distribution. Recessionary pressures on the economy and the markets in which our customers operate, as well as adverse trends in buying patterns from customers, can change expected results. Costs and difficulties in complying with laws and regulations, including those administered by the United States Food and Drug Administration, can result
in
unanticipated
expenses and delays and interruptions to the sale of new and existing products, as can the uncertainty of regulatory approvals and the regulatory process (including the currently ongoing study and other FDA actions regarding the Company’s LeadCare 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 outcome of goodwill impairment testing and the impact of possible goodwill impairments on Meridian’s earnings and financial results. Meridian cannot predict the possible impact of U.S. health care legislation enacted in 2010 – the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act – and any modification or repeal of any of the provisions thereof initiated by Congress or the presidential administration, 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, trade wars, increased tariffs, and natural disasters and other events could have a materially adverse effect on Meridian’s results of operations and revenues. In the past, the Company has identified a material weakness in our internal control over financial reporting, which has been remediated, but the Company can make no assurances that a material weakness will not be identified in the future, which if identified and not properly corrected, could materially adversely affect our operations and result in material misstatements in our financial statements. Meridian also is subject to risks and uncertainties related to disruptions to or reductions in business operations or prospects due to pandemics, epidemics, widespread health emergencies, or outbreaks of infectious diseases such as the coronavirus disease
COVID-19.
In addition to the factors described in this paragraph, as well as those factors identified from time to time in our filings with the Securities and Exchange Commission, Part I, Item 1A Risk Factors of our most recent 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.


Table of Contents

PART I. FINANCIAL INFORMATION

Item 1. Financial Statements

MERIDIAN BIOSCIENCE, INC. AND SUBSIDIARIES

Condensed Consolidated Statements of Operations (Unaudited)

(dollar and share amounts in thousands, except per share data)

   Three Months Ended  Six Months Ended 
   March 31,  March 31, 
   2019  2018  2019  2018 

NET REVENUES

  $50,248 $56,451 $101,728 $108,734

COST OF SALES

   20,910  21,882  40,818  42,155
  

 

 

  

 

 

  

 

 

  

 

 

 

GROSS PROFIT

   29,338  34,569  60,910  66,579
  

 

 

  

 

 

  

 

 

  

 

 

 

OPERATING EXPENSES

     

Research and development

   3,816  4,491  7,700  8,895

Selling and marketing

   6,911  8,647  14,474  17,461

General and administrative

   7,388  8,842  16,286  18,090

Acquisition and restructuring costs

   785  3,458  872  4,192

Litigation costs

   603  1,453  1,192  2,202
  

 

 

  

 

 

  

 

 

  

 

 

 

Total operating expenses

   19,503  26,891  40,524  50,840
  

 

 

  

 

 

  

 

 

  

 

 

 

OPERATING INCOME

   9,835  7,678  20,386  15,739

OTHER INCOME (EXPENSE)

     

Interest income

   204  90  353  162

Interest expense

   (347  (379  (710  (774

Other, net

   (445  (165  (306  (245
  

 

 

  

 

 

  

 

 

  

 

 

 

Total other income (expense)

   (588  (454  (663  (857
  

 

 

  

 

 

  

 

 

  

 

 

 

EARNINGS BEFORE INCOME TAXES

   9,247  7,224  19,723  14,882

INCOME TAX PROVISION

   2,153  1,936  4,523  3,292
  

 

 

  

 

 

  

 

 

  

 

 

 

NET EARNINGS

  $7,094 $5,288 $15,200 $11,590
  

 

 

  

 

 

  

 

 

  

 

 

 

BASIC EARNINGS PER COMMON SHARE

  $0.17 $0.12 $0.36 $0.27

DILUTED EARNINGS PER COMMON SHARE

  $0.17 $0.12 $0.35 $0.27

WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING - BASIC

   42,496  42,323  42,472  42,289

EFFECT OF DILUTIVE STOCK OPTIONS AND RESTRICTED SHARE UNITS

   450  409  453  404
  

 

 

  

 

 

  

 

 

  

 

 

 

WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING - DILUTED

   42,946  42,732  42,925  42,693
  

 

 

  

 

 

  

 

 

  

 

 

 

ANTI-DILUTIVE SECURITIES:

     

Common share options and restricted share units

   771  1,021  742  1,015
  

 

 

  

 

 

  

 

 

  

 

 

 

DIVIDENDS DECLARED PER COMMON SHARE

  $0.125 $0.125 $0.250 $0.250
  

 

 

  

 

 

  

 

 

  

 

 

 

 
Three Months Ended
  
Six Months Ended
 
 
March 31,
  
March 31,
 
 
2020
  
2019
  
2020
  
2019
 
NET REVENUES
 $
57,296
  $
50,248
  $
104,717
  $
101,728
 
COST OF SALES
  
22,842
   
20,910
   
42,823
   
40,818
 
                 
GROSS PROFIT
  
34,454
   
29,338
   
61,894
   
60,910
 
                 
OPERATING EXPENSES
            
Research and development
  
5,386
   
3,816
   
10,210
   
7,700
 
Selling and marketing
  
6,514
   
6,911
   
13,198
   
14,474
 
General and administrative
  
10,480
   
7,388
   
19,236
   
16,286
 
Acquisition-related costs
  
1,787
   
885
   
1,787
   
972
 
Change in fair value of contingent consideration obligation
  
(2,491
  
—  
   
(1,304
  
—  
 
Restructuring costs
  
252
   
(100
  
527
   
(100
Selected legal costs
  
735
   
603
   
1,055
   
1,192
 
                 
Total operating expenses
  
22,663
   
19,503
   
44,709
   
40,524
 
                 
OPERATING INCOME
  
11,791
   
9,835
   
17,185
   
20,386
 
 
 
 
 
 
 
 
 
 
 
 
 
 
OTHER INCOME (EXPENSE)
            
Interest income
  
23
   
204
   
134
   
353
 
Interest expense
  
(532
)  
(347
)  
(1,299
)  
(710
)
Other, net
  
1,365
   
(445
)  
653
   
(306
)
                 
Total other income (expense)
  
856
   
(588
)  
(512
)  
(663
)
                 
EARNINGS BEFORE INCOME TAXES
  
12,647
   
9,247
   
16,673
   
19,723
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
INCOME TAX PROVISION
  
3,288
   
2,153
   
4,487
   
4,523
 
                 
NET EARNINGS
 $
9,359
  $
7,094
  $
12,186
  $
15,200
 
                 
BASIC EARNINGS PER COMMON SHARE
 $
0.22
  $
0.17
  $
0.28
  $
0.36
 
DILUTED EARNINGS PER COMMON SHARE
 $
0.22
  $
0.17
  $
0.28
  $
0.35
 
WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING
 -
BASIC
  
42,830
   
42,496
   
42,810
   
42,472
 
EFFECT OF DILUTIVE STOCK OPTIONS AND RESTRICTED SHARE UNITS
  
138
   
450
   
143
   
453
 
                 
WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING
 -
DILUTED
  
42,968
   
42,946
   
42,953
   
42,925
 
                 
ANTI-DILUTIVE SECURITIES:
            
Common share options and restricted share units
  
1,635
   
771
   
1,520
   
742
 
                 
DIVIDENDS DECLARED PER COMMON SHARE
 $
—  
  $
0.125
  $
—  
  $
0.250
 
                 
The accompanying notes are an integral part of these condensed consolidated financial statements.

Page 1


MERIDIAN BIOSCIENCE, INC. AND SUBSIDIARIES

Condensed Consolidated StatementsTable of Comprehensive Income (Unaudited)

(dollar amounts in thousands)

   Three Months Ended  Six Months Ended 
   March 31,  March 31, 
   2019  2018  2019  2018 

NET EARNINGS

  $7,094 $5,288 $15,200 $11,590

Other comprehensive income (loss):

     

Foreign currency translation adjustment

   377  926  (339  1,217

Unrealized gain (loss) on cash flow hedge

   (310  424  (887  765

Income taxes related to items of other comprehensive income

   78  (107  223  (219
  

 

 

  

 

 

  

 

 

  

 

 

 

Other comprehensive income (loss), net of tax

   145  1,243  (1,003  1,763
  

 

 

  

 

 

  

 

 

  

 

 

 

COMPREHENSIVE INCOME

  $7,239 $6,531 $14,197 $13,353
  

 

 

  

 

 

  

 

 

  

 

 

 

Contents

MERIDIAN BIOSCIENCE, INC. AND SUBSIDIARIES
Condensed Consolidated Statements of Comprehensive Income (Unaudited)
(dollar amounts in thousands)
 
Three Months Ended
  
Six Months Ended
 
 
March 31,
  
March 31,
 
 
2020
  
2019
  
2020
  
2019
 
NET EARNINGS
 $9,359  $7,094  $12,186  $15,200 
Other comprehensive income (loss):
            
Foreign currency translation adjustment
  
(2,786
  
377
   
(18
)  
(339
)
Unrealized loss on cash flow hedge
  
(313
)  
(310
  
(313
)  
(887
)
Reclassification of gain on cash flow hedge
  
(77
)  
—  
   
(154
)  
—  
 
Income taxes related to items of other comprehensive income
  
96
   
78
   
115
   
223
 
                 
Other comprehensive income (loss), net of tax
  
(3,080
  
145
   
(370
)  
(1,003
)
                 
COMPREHENSIVE INCOME
 $
6,279
  $
7,239
  $
11,816
  $
14,197
 
                 
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)

(dollar amounts in thousands)

Six Months Ended March 31,

  2019  2018 

CASH FLOWS FROM OPERATING ACTIVITIES

   

Net earnings

  $15,200 $11,590

Non-cash items included in net earnings:

   

Depreciation of property, plant and equipment

   2,562  2,236

Amortization of intangible assets

   1,658  1,883

Amortization of deferred instrument costs

   —    401

Stock-based compensation

   2,368  1,975

Deferred income taxes

   (677  (1,576

Change in:

   

Accounts receivable

   (951  (4,185

Inventories

   832  (2,370

Prepaid expenses and other current assets

   286  754

Accounts payable and accrued expenses

   (1,267  3,746

Income taxes payable

   1,108  (775

Other, net

   (149  160
  

 

 

  

 

 

 

Net cash provided by operating activities

   20,970  13,839
  

 

 

  

 

 

 

CASH FLOWS FROM INVESTING ACTIVITIES

   

Purchase of property, plant and equipment

   (2,113  (2,160
  

 

 

  

 

 

 

Net cash used for investing activities

   (2,113  (2,160
  

 

 

  

 

 

 

CASH FLOWS FROM FINANCING ACTIVITIES

   

Dividends paid

   (10,612  (10,577

Payments on term loan

   (2,250  (2,250

Proceeds and tax benefits from exercises of stock options

   524  —  
  

 

 

  

 

 

 

Net cash used for financing activities

   (12,338  (12,827
  

 

 

  

 

 

 

Effect of Exchange Rate Changes on Cash and Equivalents and Restricted Cash

   (185  476
  

 

 

  

 

 

 

Net Increase (Decrease) in Cash and Equivalents and Restricted Cash

   6,334  (672

Cash and Equivalents and Restricted Cash at Beginning of Period

   60,763  58,072
  

 

 

  

 

 

 

Cash and Equivalents and Restricted Cash at End of Period

  $67,097 $57,400
  

 

 

  

 

 

 

Cash and Equivalents

  $66,097 $56,400

Restricted Cash

   1,000  1,000
  

 

 

  

 

 

 

Cash and Equivalents and Restricted Cash at End of Period

  $67,097 $57,400
  

 

 

  

 

 

 

         
Six Months Ended March 31,
 
2020
  
2019
 
CASH FLOWS FROM OPERATING ACTIVITIES
      
Net earnings
 $
 12,186
  $
 15,200
 
Non-cash
items included in net earnings:
      
Depreciation of property, plant and equipment
  
2,439
   
2,562
 
Amortization of intangible ass
e
ts
  
3,449
   
1,658
 
Stock-based compensation
  
1,759
   
2,368
 
Deferred income taxes
  
656
   
(677
)
Change in accrued contingent consideration
  
(1,304
  
—  
 
Change in
 the following
:
      
Accounts receivable
  
(4,950
)  
(951
)
Inventories
  
(2,511
  
832
 
Prepaid expenses and other current assets
  
1,278
   
286
 
Accounts payable and accrued expenses
  
1,621
   
(1,267
)
Income taxes payable
  
400
   
1,108
 
Other, net
  
692
   
(68
)
         
Net cash provided by operating activities
  
15,715
   
21,051
 
         
CASH FLOWS FROM INVESTING ACTIVITIES
      
Purchase of property, plant and equipment
  
(1,543
)  
(2,113
)
         
Net cash used for investing activities
  
(1,543
)  
(2,113
)
         
CASH FLOWS FROM FINANCING ACTIVITIES
      
Dividends paid
  
—  
   
(10,612
)
Payment on revolving credit facility
  (27,000
)
  —   
Payment of debt issuance costs
  (116
)
  —   
Payments on term loan
  
—  
   
(2,250
)
Proceeds from exercise of stock options
  
—  
   
443
 
         
Net cash used for financing activities
  
(27,116
)  
(12,419
)
         
Effect of Exchange Rate Changes on Cash and Equivalents and Restricted Cash
  
97
   
(185
)
         
Net Increase (Decrease) in Cash and Equivalents and Restricted Cash
  
(12,847
  
6,334
 
Cash and Equivalents and Restricted Cash at Beginning of Perio
d
  62,397   60,763 
         
Cash and Equivalents and Restricted Cash at End of Period
 $
 49,550
  $
 67,097
 
         
         
Cash and Equivalents
 $
 49,550
  $
 66,097
 
Restricted Cash
  
   1,000 
         
Cash and Equivalents and Restricted Cash at End of Period
 $
49,550
  $
67,097
 
         
The accompanying notes are an integral part of these condensed consolidated financial statements.

Page 3


MERIDIAN BIOSCIENCE, INC. AND SUBSIDIARIES

Condensed Consolidated Balance Sheets

(dollar amounts in thousands)

ASSETS

   March 31,
2019

(Unaudited)
   September 30,
2018
 

CURRENT ASSETS

    

Cash and equivalents

  $66,097  $59,763

Accounts receivable, less allowances of $437 and $310

   33,031   32,336

Inventories

   40,866   41,993

Prepaid expenses and other current assets

   4,671   4,961
  

 

 

   

 

 

 

Total current assets

   144,665   139,053
  

 

 

   

 

 

 

PROPERTY, PLANT AND EQUIPMENT, at Cost

    

Land

   1,155   1,160

Buildings and improvements

   32,454   32,444

Machinery, equipment and furniture

   60,394   50,606

Construction in progress

   1,806   1,631
  

 

 

   

 

 

 

Subtotal

   95,809   85,841

Less: accumulated depreciation and amortization

   65,039   55,846
  

 

 

   

 

 

 

Net property, plant and equipment

   30,770   29,995
  

 

 

   

 

 

 

OTHER ASSETS

    

Goodwill

   54,642   54,637

Other intangible assets, net

   21,452   23,113

Restricted cash

   1,000   1,000

Deferred instrument costs, net

   —     1,239

Fair value of interest rate swap

   835   1,722

Deferred income taxes

   110   130

Other assets

   490   488
  

 

 

   

 

 

 

Total other assets

   78,529   82,329
  

 

 

   

 

 

 

TOTAL ASSETS

  $253,964  $251,377
  

 

 

   

 

 

 

         
 
March 31,
2020
(Unaudited)
  
September 30,
2019
 
CURRENT ASSETS
      
Cash and equivalents
 $
49,550
  $
62,397
 
Accounts receivable, less allowances of $521 and $537, respectivel
y
  
40,184
   
35,608
 
Inventories
  
41,008
   
39,617
 
Prepaid expenses and other current asset
s
  
5,847
   
7,139
 
         
Total current assets
  
136,589
   
144,761
 
         
PROPERTY, PLANT AND EQUIPMENT, at Cost
      
Land
  
987
   
982
 
Buildings and improvements
  
32,004
   
31,904
 
Machinery, equipment and furniture
  
66,006
   
64,155
 
Construction in progress
  
1,252
   
522
 
         
Subtotal
  
100,249
   
97,563
 
Less: accumulated depreciation and amortization
  
69,875
   
66,996
 
         
Net property, plant and equipment
  
30,374
   
30,567
 
         
OTHER ASSETS
      
Goodwill
  
89,198
   
89,241
 
Other intangible assets, net
  
56,848
   
60,243
 
Right-of-use
assets
  
5,355
   
—  
 
Deferred income taxes
  
137
   
156
 
Other assets
  
573
   
510
 
         
Total other assets
  
152,111
   
150,150
 
         
TOTAL ASSETS
 $
319,074
  $
325,478
 
         
The accompanying notes are an integral part of these condensed consolidated financial statements.

Page 4


Table of Contents

MERIDIAN BIOSCIENCE, INC. AND SUBSIDIARIES

Condensed Consolidated Balance Sheets

(dollar amounts in thousands)

LIABILITIES AND SHAREHOLDERS’ EQUITY

   March 31,
2019

(Unaudited)
  September 30,
2018
 

CURRENT LIABILITIES

   

Accounts payable

  $7,838 $6,260

Accrued employee compensation costs

   5,357  7,263

Other accrued expenses

   3,724  5,065

Current portion of long-term debt

   6,000  5,250

Income taxes payable

   1,163  335
  

 

 

  

 

 

 

Total current liabilities

   24,082  24,173
  

 

 

  

 

 

 

NON-CURRENT LIABILITIES

   

Post-employment benefits

   2,476  2,646

Long-term debt

   41,946  44,930

Long-term income taxes payable

   736  441

Deferred income taxes

   3,079  3,769
  

 

 

  

 

 

 

Totalnon-current liabilities

   48,237  51,786
  

 

 

  

 

 

 

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, 42,515,142 and 42,399,962 shares issued, respectively

   —    —  

Additionalpaid-in capital

   131,951  129,193

Retained earnings

   54,074  49,602

Accumulated other comprehensive loss

   (4,380  (3,377
  

 

 

  

 

 

 

Total shareholders’ equity

   181,645  175,418
  

 

 

  

 

 

 

TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY

  $253,964 $251,377
  

 

 

  

 

 

 

         
 
March 31,
2020
(Unaudited)
  
September 30,
2019
 
CURRENT LIABILITIES
      
Accounts payable
 $
7,879
  $
7,238
 
Accrued employee compensation costs
  
9,009
   
7,938
 
Accrued interest
  
180
   
498
 
Current portion of acquisition consideration
  
13,656
   
—  
 
Current operating lease obligations
  
1,350
   
—  
 
Other accrued expenses
  
3,445
   
3,260
 
Income taxes payable
  
2,366
   
1,980
 
         
Total current liabilities
  
37,885
   
20,914
 
         
NON-CURRENT LIABILITIES
      
Acquisition consideration
  
17,242
   
32,202
 
Post-employment benefits
  
2,458
   
2,500
 
Fair value of interest rate swaps
  
313
   
 
 
 
Long-term operating lease obligations
  
4,111
   
—  
 
Long-term debt
  
48,824
   
75,824
 
Long-term income taxes payable
  
549
   
549
 
Deferred income taxes
  
3,159
   
2,522
 
Total
non-current
liabilities
  
76,656
   
113,597
 
COMMITMENTS AND CONTINGENCIES
      
 
 
 
 
 
 
 
SHAREHOLDERS’ EQUITY
      
Preferred stock, no par value; 1,000,000 shares authorized; 0ne issued
  
—   
   
���   
 
Common shares, no par value; 71,000,000 shares authorized, 42,831,267 and 42,712,296 shares issued, respectively
  
—   
   
—   
 
Additional
paid-in
capital
  
134,584
   
132,834
 
Retained earnings
  
75,294
   
63,108
 
Accumulated other comprehensive loss
  
(5,345
)  
(4,975
)
Total shareholders’ equity
  
204,533
   
190,967
 
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY
 $
  319,074
  $
  325,478
 
The accompanying notes are an integral part of these condensed consolidated financial statements.

Page 5


Table of Contents

MERIDIAN BIOSCIENCE, INC. AND SUBSIDIARIES

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

(dollar and share amounts in thousands, except per share data)

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

THREE MONTHS ENDED MARCH 31, 2019

        

Balance at December 31, 2018

   42,489  $130,876  $52,291 $(4,525 $178,642

Cash dividends paid - $0.125 per share

   —      —      (5,311  —     (5,311

Conversion of restricted share units and exercise of stock options

   26   377   —     —     377

Stock compensation expense

   —      698   —     —     698

Net earnings

   —      —      7,094  —     7,094

Foreign currency translation adjustment

   —      —      —     377  377

Hedging activity, net of tax

   —      —      —     (232  (232
  

 

 

   

 

 

   

 

 

  

 

 

  

 

 

 

Balance at March 31, 2019

   42,515  $131,951  $54,074 $(4,380 $181,645
  

 

 

   

 

 

   

 

 

  

 

 

  

 

 

 

THREE MONTHS ENDED MARCH 31, 2018

        

Balance at December 31, 2017

   42,307  $127,367  $47,937 $(2,426 $172,878

Cash dividends paid - $0.125 per share

   —      —      (5,289  —     (5,289

Conversion of restricted share units

   37   —      —     —     —   

Stock compensation expense

   —      216   —     —     216

Net earnings

   —      —      5,288  —     5,288

Foreign currency translation adjustment

   —      —      —     926  926

Hedging activity, net of tax

   —      —      —     317  317
  

 

 

   

 

 

   

 

 

  

 

 

  

 

 

 

Balance at March 31, 2018

   42,344  $127,583  $47,936 $(1,183 $174,336
  

 

 

   

 

 

   

 

 

  

 

 

  

 

 

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

SIX MONTHS ENDED MARCH 31, 2019

        

Balance at September 30, 2018

   42,400  $129,193  $49,602 $(3,377 $175,418

Cash dividends paid - $0.250 per share

   —      —      (10,612  —     (10,612

Conversion of restricted share units and exercise of stock options

   115   390   —     —     390

Stock compensation expense

   —      2,368   —     —     2,368

Net earnings

   —      —      15,200  —     15,200

Foreign currency translation adjustment

   —      —      —     (339  (339

Hedging activity, net of tax

   —      —      —     (664  (664

Adoption of ASU2014-09

   —      —      (116  —     (116
  

 

 

   

 

 

   

 

 

  

 

 

  

 

 

 

Balance at March 31, 2019

   42,515  $131,951  $54,074 $(4,380 $181,645
  

 

 

   

 

 

   

 

 

  

 

 

  

 

 

 

SIX MONTHS ENDED MARCH 31, 2018

        

Balance at September 30, 2017

   42,207  $125,608  $46,923 $(2,946 $169,585

Cash dividends paid - $0.250 per share

   —      —      (10,577  —     (10,577

Conversion of restricted share units

   137   —      —     —     —   

Stock compensation expense

   —      1,975   —     —     1,975

Net earnings

   —      —      11,590  —     11,590

Foreign currency translation adjustment

   —      —      —     1,217  1,217

Hedging activity, net of tax

   —      —      —     546  546
  

 

 

   

 

 

   

 

 

  

 

 

  

 

 

 

Balance at March 31, 2018

   42,344  $127,583  $47,936 $(1,183 $174,336
  

 

 

   

 

 

   

 

 

  

 

 

  

 

 

 

                     
 
Common
Shares
Issued
  
Additional
Paid-In

Capital
  
Retained
Earnings
  
Accumulated Other
Comprehensive
Income (Loss)
  
Total
Shareholders’
Equity
 
THREE MONTHS ENDED MARCH 31, 2020
               
Balance at December 31, 2019
  
42,828
  $
133,622
  $
65,935
  $
(2,265
) $
197,292
 
Conversion of restricted share units
  
3
   
(9
  
—   
   
—   
   
(9
Stock compensation expense
  
—   
   
971
   
—   
   
—   
   
971
 
Net earnings
  
—   
   
—   
   
9,359
   
—   
   
9,359
 
Foreign currency translation adjustment
  
—   
   
—   
   
—   
   
(2,786
  
(2,786
Hedging activity, net of tax
  
—   
   
—   
   
—   
   
(294
)  
(294
)
Balance at March 31, 2020
  
42,831
  $
134,584
  $
75,294
  $
(5,345
) $
204,533
 
THREE MONTHS ENDED MARCH 31, 2019
               
Balance at December 31, 2018
  
42,489
  $
130,876
  $
52,291
  $
(4,525
) $
178,642
 
Cash dividends paid
 -
 
$0.125 per share
  
—   
   
—   
   
(5,311
)  
—   
   
(5,311
)
Conversion of restricted share units and exercise of stock options
  
26
   
377
   
—   
   
—   
   
377
 
Stock compensation expense
  
—   
   
698
   
—   
   
—   
   
698
 
Net earnings
  
—   
   
—   
   
7,094
   
—   
   
7,094
 
Foreign currency translation adjustment
  
—   
   
—   
   
—   
   
377
   
377
 
Hedging activity, net of tax
  
—   
   
—   
   
—   
   
(232
)  
(232
)
Balance at March 31, 2019
  
42,515
  $
131,951
  $
54,074
  $
(4,380
) $
181,645
 
                
 
Common
Shares
Issued
  
Additional
Paid-In

Capital
  
Retained
Earnings
  
Accumulated Other
Comprehensive
Income (Loss)
  
Total
Shareholders’
Equity
 
SIX MONTHS ENDED MARCH 31, 2020
               
Balance at September 30, 2019
  
42,712
  $
132,834
  $
63,108
  $
(4,975
) $
190,967
 
Conversion of restricted share units 
  
119
   
(9
  
—   
   
—   
   
(9
Stock compensation expense
  
—   
   
1,759
   
—   
   
—   
   
1,759
 
Net earnings
  
—   
   
—   
   
12,186
   
—   
   
12,186
 
Foreign currency translation adjustment
  
—   
   
—   
   
—   
   
(18
)  
(18
)
Hedging activity, net of tax
  
—   
   
—   
   
—   
   
(352
)  
(352
)
Balance at March 31, 2020
  
42,831
  $
134,584
  $
75,294
  $
(5,345
) $
204,533
 
SIX MONTHS ENDED MARCH 31, 2019
               
Balance at September 30, 2018
  
42,400
  $
129,193
  $
49,602
  $
(3,377
) $
175,418
 
Cash dividends paid
 -
 
$0.250 per share
  
—   
   
—   
   
(10,612
)  
—   
   
(10,612
)
Conversion of restricted share units and exercise of stock options
  
115
   
390
   
—   
   
—   
   
390
 
Stock compensation expense
  
—   
   
2,368
   
—   
   
—   
   
2,368
 
Net earnings
  
—   
   
—   
   
15,200
   
—   
   
15,200
 
Foreign currency translation adjustment
  
—   
   
—   
   
—   
   
(339
)  
(339
)
Hedging activity, net of tax
  
—   
   
—   
   
—   
   
(664
)  
(664
)
Adoption of ASU
2014-09
  
—   
   
—   
   
(116
)  
—   
   
(116
)
Balance at March 31, 2019
  
42,515
  $
131,951
  $
54,074
  $
(4,380
) $
181,645
 
The accompanying notes are an integral part of these condensed consolidated financial statements.

Page 6


Table of Contents

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, 2019,2020, the results of its operations for the threethree- and six month
six-month
periods ended March 31, 20192020 and 2018,2019, and its cash flows for the six monthsix-month periods ended March 31, 20192020 and 2018.2019. These statements should be read in conjunction with the consolidated financial statements and footnotes thereto included in the Company’s fiscal 20182019 Annual Report on Form
10-K.
 Financial information as of September 30, 20182019 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.

In December 2019, the SARS-CoV-2 virus emerged in Wuhan, China and spread to other parts of the world. In March 2020, the World Health Organization (“WHO”) designated
COVID-19
(the disease caused by SARS-CoV-2) a global pandemic. Governments have implemented lockdown and
shelter-in-place
orders, requiring many
non-essential
businesses to shut down operations for the time being. The Company’s business, however, is deemed “essential” and it has continued to operate, manufacture and distribute its products to customers globally.
While
COVID-19
has not had a material negative impact on the Company’s operations, financial condition or cash flows as of the date of this filing, we cannot reasonably predict the extent of the impact of
COVID-19
on our future results of operations and cash flows due to the continued uncertainty around the duration and severity of the pandemic. See Management’s Discussion and Analysis of Financial Condition and Results of Operations included herein for additional discussion of the effects of the COVID-19 pandemic on the Company and its results of operations.
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 20182019 Annual Report on Form
10-K
and should be referred to for a description of the Company’s current significant accounting policies, with the exception of Revenue Recognition
 and Fair Value Measurements
, which is
are
set forth below.

(a) Revenue Recognition –

Adoption of New Standard

On October 1, 2018, we adopted ASUNo. 2014-09,Revenue from Contracts with Customers, using the modified retrospective transition method applied to those contracts that were not completed as of that date. Results for reporting periods beginning on or after October 1, 2018 are presented under the new guidance, while prior period amounts are not adjusted and continue to be reported in accordance with previously applicable guidance.

Upon adoption, we recorded a reduction of $116 to the opening balance of retained earnings as of October 1, 2018. This adjustment is related to writing off the book value of clinical diagnostic testing instruments located at customers for which there is no contractual arrangement for the instrument to be returned to the Company. Instruments placed with customers under an agreement to return the instrument to the Company were reclassified to machinery and equipment. Prior to adoption of the new guidance, all instruments placed with customers were capitalized and amortized over an estimated three-year utilization period, with the net balance reflected as deferred instrument costs.

Page 7


The following table summarizes the impact of the new revenue standard on our opening balance sheet:

   Balance at
September 30,
2018
   New Revenue
Standard
Adjustment
   Balance at
October 1,
2018
 

PROPERTY, PLAN AND EQUIPMENT

      

Machinery, equipment and furniture

  $50,606   $8,696   $59,302 

Accumulated depreciation and amortization

   (55,846   (7,611   (63,457

OTHER ASSETS

      

Deferred instrument costs, net

   1,239    (1,239   —  

NON-CURRENT LIABILITIES

      

Deferred income taxes

   (3,769   38    (3,731

SHAREHOLDERS’ EQUITY

      

Retained earnings

   (49,602   116    (49,486

The adoption of this new standard had an immaterial impact on our reported total revenues and operating income, as compared to what would have been reported under the prior standard. Our accounting policies under the new standard were applied prospectively and are noted below following the discussion of Revenue Disaggregation.

Revenue Disaggregation

The following tables present our revenues disaggregated by major geographic region, major product platform and disease state (Diagnostics only):

Revenue by Reportable Segment & Geographic Region

   Three Months Ended March 31,  Six Months Ended March 31, 
   2019   2018   Inc (Dec)  2019   2018   Inc (Dec) 

Diagnostics-

           

Americas

  $27,278  $33,351   (18)%  $58,425  $64,926   (10)% 

EMEA

   5,535   5,912   (6)%   10,620   11,327   (6)% 

ROW

   687   519   32  1,120   1,019   10
  

 

 

   

 

 

   

 

 

  

 

 

   

 

 

   

 

 

 

Total Diagnostics

   33,500   39,782   (16)%   70,165   77,272   (9)% 
  

 

 

   

 

 

   

 

 

  

 

 

   

 

 

   

 

 

 

Life Science-

           

Americas

   5,453   5,121   6  9,975   10,373   (4)% 

EMEA

   7,901   7,478   6  15,376   12,659   21

ROW

   3,394   4,070   (17)%   6,212   8,430   (26)% 
  

 

 

   

 

 

   

 

 

  

 

 

   

 

 

   

 

 

 

Total Life Science

   16,748   16,669   —    31,563   31,462   —  
  

 

 

   

 

 

   

 

 

  

 

 

   

 

 

   

 

 

 

Consolidated

  $50,248  $56,451   (11)%  $101,728  $108,734   (6)% 
  

 

 

   

 

 

   

 

 

  

 

 

   

 

 

   

 

 

 

 
Three Months Ended March 31,
  
Six Months Ended March 31,
 
 
2020
  
2019
  
Inc (Dec)
  
2020
  
2019
  
Inc (Dec)
 
Diagnostics-
                  
Americas
 $
27,670
  $
26,263
   
5
% $
55,405
  $
56,686
   
(2
)%
EMEA
  
6,777
   
6,549
   
3
%  
13,277
   
12,351
   
7
%
ROW
  
495
   
688
   
(28
)%  
1,051
   
1,128
   
(7
)%
                         
Total Diagnostics
  
34,942
   
33,500
   
4
% 
 
 
 
 
69,733
   
70,165
   
(1
)%
                         
Page 8

7


Table of Contents

Life Science-
                  
Americas
  
4,612
   
5,454
   
(15
)%  
8,627
   
9,976
   
(14
)%
EMEA
  
9,946
   
7,852
   
27
%  
14,914
   
15,213
   
(2
)%
ROW
  
7,796
   
3,442
   
126
%  
11,443
   
6,374
   
80
%
                         
Total Life Science
  
22,354
   
16,748
   
33
%  
34,984
   
31,563
   
11
%
                         
Consolidated
 $
57,296
  $
50,248
  
 
 
 
 
 
14
% $
104,717
  $
101,728
  
 
 
 
 
 
 
 
3
%
                         
Revenue by Product Platform/Type

   Three Months Ended March 31,  Six Months Ended March 31, 
   2019   2018   Inc (Dec)  2019   2018   Inc (Dec) 

Diagnostics-

           

Molecular assays

  $7,132  $9,976   (29)%  $14,434  $18,692   (23)% 

Immunoassays & blood chemistry assays

   26,368   29,806   (12)%   55,731   58,580   (5)% 
  

 

 

   

 

 

   

 

 

  

 

 

   

 

 

   

 

 

 

Total Diagnostics

  $33,500  $39,782   (16)%  $70,165  $77,272   (9)% 
  

 

 

   

 

 

   

 

 

  

 

 

   

 

 

   

 

 

 

Life Science-

           

Molecular reagents

  $5,390  $6,143   (12)%  $11,998  $11,832   1

Immunological reagents

   11,358   10,526   8  19,565   19,630   —  
  

 

 

   

 

 

   

 

 

  

 

 

   

 

 

   

 

 

 

Total Life Science

  $16,748  $16,669   —   $31,563  $31,462   —  
  

 

 

   

 

 

   

 

 

  

 

 

   

 

 

   

 

 

 

 
Three Months Ended March 31,
  
Six Months Ended March 31,
 
 
2020
  
2019
  
Inc (Dec)
  
2020
  
2019
  
Inc (Dec)
 
Diagnostics-
                  
Molecular assays
 $
7,238
  $
7,084
   
2
% $
14,077
  $
14,314
   
(2
)%
Immunoassays & blood chemistry assays
  
27,704
   
26,416
   
5
%  
55,656
   
55,851
   
-
%
                         
Total Diagnostics
 $
34,942
  $
33,500
   
4
% $
69,733
  $
70,165
   
(1
)%
                         
Life Science-
                  
Molecular reagents
 $
11,534
  $
5,390
   
114
% $
16,892
  $
11,998
   
41
%
Immunological reagents
  
10,820
   
11,358
   
(5
)%  
18,092
   
19,565
   
(8
)
%
                         
Total Life Science
 $
22,354
  $
16,748
   
33
% $
34,984
  $
31,563
   
11
%
                         
Revenue by Disease State (Diagnostics only)

   Three Months Ended March 31,  Six Months Ended March 31, 
   2019   2018   Inc (Dec)  2019   2018   Inc (Dec) 

Diagnostics-

           

Gastrointestinal assays

  $16,177  $19,149   (16)%  $34,792  $39,419   (12)% 

Respiratory illness assays

   7,553   9,543   (21)%   15,534   17,029   (9)% 

Blood chemistry assays

   4,330   4,257   2  8,760   8,523   3

Other

   5,440   6,833   (20)%   11,079   12,301   (10)% 
  

 

 

   

 

 

   

 

 

  

 

 

   

 

 

   

 

 

 

Total Diagnostics

  $33,500  $39,782   (16)%  $70,165  $77,272   (9)% 
  

 

 

   

 

 

   

 

 

  

 

 

   

 

 

   

 

 

 

 
Three Months Ended March 31,
  
Six Months Ended March 31,
 
 
2020
  
2019
  
Inc (Dec)
  
2020
  
2019
  
Inc (Dec)
 
Diagnostics-
                  
Gastrointestinal assays
 $
14,014
  $
16,177
   
(13
)% $
30,060
  $
34,792
   
(14
)%
Respiratory illness assays
  
10,863
   
7,553
   
44
%  
18,612
   
15,534
   
20
%
Blood chemistry assays
  
4,329
   
4,330
   
-
%  
9,479
   
8,760
   
8
%
Other
  
5,736
   
5,440
   
5
%  
11,582
   
11,079
   
5
%
                         
Total Diagnostics
 $
34,942
  $
33,500
   
4
% $
69,733
  $
70,165
   
(1
)%
                         
Revenue Policies

Product Sales

Revenue from contracts with customers is recognized in an amount that reflects the consideration we expect to receive in exchange for products when obligations under such contracts are satisfied. Revenue is generally recognized at a
point-in-time
when products are shipped and titlecontrol has passed to the customer. Such contracts can include various combinations of products that are generally accounted for as distinct performance obligations.

Revenue is reduced in the period of sale for fees paid to distributors, which are inseparable from the distributor’s purchase of our product and for which we receive no goods or services in return. Revenue for the Diagnostics segment is reduced at the date of sale for product price adjustments duepayable to certain distributors under local contracts. Management estimates accruals for distributor price adjustments based on local contract terms, sales data provided by distributors, historical statistics, current trends, and other factors. Changes to the accruals are recorded in the period that they become known. Such accruals are netted against accounts receivable.

Shipping and handling costs incurred after control of the product is transferred to our customers are treated as fulfillment costs and not a separate performance obligation.

Page 8

Table of Contents
Our payment terms differ by jurisdiction and customer but payment is generally required in a term ranging from 30 to 90 days from the date of shipment or satisfaction of the performance obligation. Trade accounts receivable are recorded in the accompanying
Con
densed
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.
Customer invoices are charged off against the allowance when we believe it is probable that the invoices will not be paid.

Page 9


Practical Expedients and Exemptions

Revenue is recognized net of any taxes collected from customers (sales tax, value added tax, etc.), which are subsequently remitted to government authorities.

Our diagnostic assay 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 probable and estimable.

We expense as incurred the costs to obtain contracts, as the amortization period would have beenbe one year or less. These costs, recorded within selling and marketing expense, include our internal sales force compensation programs and certain partner sales incentive programs, as we have determined that annual compensation is commensurate with annual selling activities.

Reagent Rental Arrangements

Our Alethia and LeadCare

Certain of our Diagnostics segment’s product platforms require the use of instruments for the tests to be processed. In many cases, a customer is given use of the instrument provided they continue purchasing the associated tests, also referred to as “consumables” or “reagents”. If a customer stops purchasing the consumables, the instrument must be returned to Meridian.us. Such arrangements are common practice in the diagnostics industry and are referred to as “Reagent Rental” agreements. These agreementsRentals”. Reagent Rentals may also include instrument related services such as a limited replacement warranty, training and installation. We concluded that the use of the instrument and related services (collectively known as “lease elements”) are not within the scope of ASUNo. 2014-09Accounting Standards
Codification (“ASC”) 606,
Revenue from Contracts with Customers
but rather ASU2016-02,
ASC 842,
Leases
. Accordingly, we first allocate the transaction price between the lease elements and the
non-lease
elements based on estimates of relative standalone selling prices. Lease revenue is derived solely from the sale of consumables and is therefore recognized monthly as earned, which coincides with the transfer of control of the
non-lease
elements.

For the portion of the transaction price allocated to the
non-lease
elements, which are principally the test kits, the related revenue will beis recognized at a
point-in-time
when control transfers.

Revenue allocated to the lease elements of these Reagent Rental arrangements represent less than 1% of totaltotaled approximately $1,125 and $1,050 in the three months ended March 31, 2020 and 2019, respectively, and $2,250 and $2,100 in the six months ended March 31, 2020 and 201
9
, respectively. Such revenue and areis included as part of net revenues in our Condensed Consolidated Statements of Income.

Operations.

(b)
Fair Value Measurements –
Certain assets
and liabilities are recorded at fair value in accordance with ASC 
820-10,
Fair Value Measurements and Disclosures
. ASC
820-10
defines fair value as the price that would be received to sell an asset or would be paid to transfer a liability in an orderly transaction between market participants at the measurement date. ASC
820-10
establishes a three-level hierarchy, which prioritizes the inputs to valuation techniques used to measure fair value. The hierarchy level assigned to each asset and liability is based on the assessment of the transparency and reliability of the inputs used in the valuation of such items at the measurement date based on the lowest level of input that is significant to the fair value measurement. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurements) and the lowest priority to unobservable inputs (Level 3 measurements).
Page 9

Assets and liabilities measured and reported at fair value are classified and disclosed in one of the following categories based on inputs:
Level 1
Unadjusted quoted prices in active markets that are accessible at the measurement date for identical, unrestricted assets or liabilities
Level 2
Quoted prices in markets that are not active and financial instruments for which all significant inputs are observable, either directly or indirectly
Level 3
Prices or valuations that require inputs that are both significant to the fair value measurement and unobservable
As described in Note 3, we acquired the business of GenePOC in fiscal 2019. The fair value of the acquired accounts receivable and other current assets and the fair value of the assumed accounts payable and accrued expenses approximated their carrying value at the acquisition date. Inventories, property, plant and equipment, intangible assets and contingent consideration were valued using Level 3 inputs.
The following table provides information by level for financial assets and liabilities that are measured at fair value on a recurring basis:
                 
 
 
 
  
Fair Value Measurements Using
Inputs Considered as
 
 
 
Carrying
Value
  
Level 1
  
Level 2
  
Level 3
 
Interest rate swaps (see Note 9) -
            
As of March 31, 2020
 
$
(313
) $
 
 
  $
(313
) $
 
 
 
As of September 30, 2019
 $
 
 
  $
 
 
  $
 
 
  $
 
 
 
Contingent consideration -
            
As of March 31, 2020
 $
(25,898
 $
 
 
  $
 
 
  $
(25,898
As of September 30, 201
9
 $
(27,202
 $
 
 
  $
 
 
  $
(27,202
In connection with the acquisition of the business of GenePOC and as described in Note 3, the Company is required to make contingent consideration payments of up to $70,000, comprised of up to $20,000 for achievement of product development milestones and up to $50,000 for achievement of certain financial targets. The fair value for the contingent payments recognized upon the acquisition as part of the purchase accounting opening balance sheet totaled $27,202. The fair value of the
product
development milestone payments was estimated by disc
o
unting the probability-weighted contingent payments to present value. Assumptions used in the calculations include probability of success, duration of the
earn-out
and discount rate. The fair value of the financial performance target payments was determined using a Monte Carlo simulation-based model. Assumptions used in these calculations include expected revenue, probability of certain developments, expected expenses and discount rate. The ultimate settlement of contingent consideration could deviate from current estimates based on the actual results of these financial measures. The liability is considered to be a Level 3 financial liability that is
re-measured
each reporting period, resulting in a value of $25,898 as of March 31, 2020.
Page 10

(c)
Recent Accounting Pronouncements –
Pronouncements

In February 2016,Adopted

On October 1, 2019, the FASBCompany adopted ASC 842,
Leases
. ASC 842 was issued ASU2016-02,Leases, which amends the accounting guidance related to leases. These changes, which are designed to increase transparency and comparability among organizations for both lesseesentities by recognizing
right-of-use
assets (“ROU assets”) and lessors, include, among other things, requiring recognition of lease assets and liabilities on the balance sheet and disclosing key information about leasinglease arrangements. AdoptionThe Company elected to adopt ASC 842 effective October 1, 2019 using the modified retrospective transition method, which was applied to leases that existed or will be entered into on or after such date, with no adjustment made to prior comparative periods. The comparative periods presented herein reflect the former lease accounting guidance and implementationthe required comparative disclosures are included in Note 7,
“Leasing Arrangements”
. There was no cumulative-effect adjustment to beginning retained earnings as a result of adopting ASC 842, and additional operating lease ROU assets and obligations of approximately $5,880 were recognized as of October 1, 2019. ROU assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent the Company’s obligation to make lease payments arising from the lease calculated by discounting fixed lease payments over the lease term at the rate implicit in the lease or the Company’s incremental borrowing rate. Lease liabilities are increased by interest and reduced by payments each period, and the ROU asset is amortized over the lease term. The Company elected the package of practical expedients permitted under the new guidance to not reassess prior conclusions related to the identification, classification and accounting for initial direct costs for leases that commenced prior to October 1, 2019. Additionally, the elections were made to not use hindsight to determine lease terms and to not separate
non-lease
 components within the lease portfolio. See Note 7 for further information.
Pronouncements Issued but Not Yet Adopted as of March 31, 2020
In March 2020, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No.
 2020-04,
Reference Rate Reform (Topic 848): Facilitation of the Effects of Reference Rate Reform on Financial Reporting
, to provide temporary optional guidance relating to reference rate reform, particularly as it relates to easing the potential burden resulting from the expected discontinuation of the LIBOR rate. The guidance provides practical expedients and exceptions for applying U.S. GAAP to contracts, hedging relationships and other transactions affected by reference rate reform if certain criteria are met, which may be applied through December 31, 2022. The Company plans to apply this guidance to such transactions and modifications of arrangements but does not expect application to have a material impact on financial condition, results of operations or cash flows.
In June 2016, the FASB issued ASU 2016-13,
Measurement of Credit Losses on Financial Instruments
, which changes the impairment model used to measure credit losses for most financial assets. We will be required to use a new forward-looking expected credit loss model that will replace the existing incurred credit loss model for our accounts receivables. The guidance is not required byeffective for fiscal years beginning after December 15, 2019, including interim periods within those fiscal years (fiscal 2021 for the Company until the beginning of fiscal 2020, althoughCompany), with early adoption is permitted. DuringThe Company does not anticipate that the second quarter of fiscal 2019, the Company commenced the process of gathering and summarizing its corporate-wide lease information in order to assess the impact that adoption of this guidance will have a material impact on its consolidated financial statements.

In August 2016, the FASB issued ASU2016-15,Classification of Certain Cash Receipts and Cash Payments. The update addresses certain specific cash flows and their treatment, with the objective being to reduce the existing diversity in how the items are presented and classified within the statement of cash flows. The Company adopted this guidance in the first quarter of fiscal 2019, with the Condensed Consolidated Statements of Cash Flows reflecting such adoption, including the information related to restricted cash.

In February 2018, the FASB issued ASU2018-02,Reclassification of Certain Tax Effects from Accumulated Other Comprehensive Income, to address certain of the recent U.S. federal income tax legislation’s impact on Accumulated Other Comprehensive Income (“AOCI”). The guidance specifically provides the option of reclassifying “stranded tax effects” related to the tax legislation from AOCI to retained earnings. Adoption and implementation of the optional guidance is not effective for the Company until the beginning of fiscal 2020, although early adoption is permitted. The Company plans to adopt this guidance in fiscal 2020 as required but does not expect adoption to have a significant impact on the Company’s consolidated results of operations, cash flows or financial position.

Page 10


Reclassifications –

(d)
Reclassifications –
Certain reclassifications have been made to the prior year financial statements to conform to the current year presentation. Such reclassifications had no impact on net earnings or shareholders’ equity.

3.

Cash and Equivalents

Acquisition of Business of GenePOC

Cash

On June 3, 2019, we acquired the business of GenePOC Inc. (“GenePOC”), a Quebec City, Quebec Province, Canada based provider of molecular diagnostic instruments and equivalents includeassays. The purchase agreement contemplates a maximum total consideration of up to $120,000, which was estimated at a total fair value of $77,526 as of the following components:

   March 31, 2019   September 30, 2018 
   Cash and
Equivalents
   Other
Assets
   Cash and
Equivalents
   Other
Assets
 

Institutional money market funds

  $20,668  $—     $20,421  $—   

Cash on hand -

        

Restricted

   —     1,000   —     1,000

Unrestricted

   45,429   —     39,342   —  
  

 

 

   

 

 

   

 

 

   

 

 

 

Total

  $66,097  $1,000  $59,763  $1,000
  

 

 

   

 

 

   

 

 

   

 

 

 

4.

Inventories

Inventories areacquisition date. Pursuant to the purchase agreement, the maximum consideration is comprised of the following:

   March 31,
2019
   September 30,
2018
 

Raw materials

  $7,473  $6,689

Work-in-process

   11,810   12,098

Finished goods - instruments

   965   1,191

Finished goods - kits and reagents

   20,618   22,015
  

 

 

   

 

 

 

Total

  $40,866  $41,993
  

 

 

   

 

 

 

following (noting that the valuation
set
the contingent consideration identified in (ii) and (iii) below at an aggregate amount of $27,202 as of the acquisition date):
5.

Intangible Assets

(i)
a $50,000 cash payment on June 3, 2019, subject to a working capital adjustment and a holdback of $5,000 to secure selling party’s performance of certain post-closing obligations;

A summary

Page 11

Table of our acquired intangible assets subject to amortization,Contents
(ii)two $10,000 installments contingent upon the achievement of certain product development milestones if achieved by September 30, 2020 and March 31, 2021, respectively; and
(iii)up to $50,000 of contingent consideration payable if certain financial performance targets are achieved during the twelve-month period ending September 30, 2022.
The total of the holdback identified in (i) above and the currently estimated value of the contingent consideration identified in (ii) and (iii) above are reflected within the accompanying Condensed Consolidated Balance Sheets as of March 31, 20192020 as follows:
Current liabilities
 -
$13,656
Reflects anticipated settlement of the first product milestone payment and September 30, 2018, isthe holdback amounts in the first quarter of fiscal 2021.
Non-current liabilities
 -
$17,242
Reflects anticipated settlement of the second product milestone payment and the financial performance targets payments in the third quarter of fiscal 2021 and first quarter of fiscal 2023, respectively.
To finance the acquisition, we utilized cash and equivalents on hand and proceeds drawn from our revolving credit facility
;
 see Note 9 for a discussion of subsequent amendments to the credit facility. Proceeds from the credit facility were also utilized to repay and settle the outstanding principal and interest due on our term loan (see Note 9). As a result of estimated total consideration exceeding the fair value of the net assets acquired, goodwill in the amount
of $34,582 was
recorded in connection with this acquisition,
most of
which will be deductible for U.S. tax purposes ratably over 15 years. The goodwill results largely from our ability to market and sell GenePOC’s technology and instrument platform through our established customer base and distribution channels.
Purchase Price Allocation
The recognized amounts of identifiable assets acquired and liabilities assumed in the acquisition of the GenePOC business are as follows:

   March 31, 2019   September 30, 2018 
   Gross
Carrying
Value
   Accumulated
Amortization
   Gross
Carrying
Value
   Accumulated
Amortization
 

Manufacturing technologies, core products and cell lines

  $22,298  $14,571  $22,297  $13,974

Trade names, licenses and patents

   8,647   5,717   8,647   5,267

Customer lists, customer relationships and supply agreements

   24,463   13,668   24,461   13,051
  

 

 

   

 

 

   

 

 

   

 

 

 

Total

  $55,408  $33,956  $55,405  $32,292
  

 

 

   

 

 

   

 

 

   

 

 

 

 
June 3,
2019
(as initially
reported)
  
Measurement
Period
Adjustments
  
June 3,
2019
(as adjusted)
 
Fair value of assets acquired -
         
Accounts receivable
 $
58
  $
 (1
) $
57
 
Inventories
  
1,617
   
(106
)  
1,511
 
Other current assets
  
77
   
7
   
84
 
Property, plant and equipment
  
1,520
   
(96
)  
1,424
 
Goodwill
  
34,482
   
100
   
34,582
 
Other intangible assets (estimated useful life):
         
License agreement (10 years)
  
5,990
   
—  
   
5,990
 
Technology (15 years)
  
34,040
   
96
   
34,136
 
Government grant (1.33 years)
  
800
   
—  
   
800
 
             
  
78,584
   
—  
   
78,584
 
Fair value of liabilities assumed -
         
Accounts payable and accrued expenses
  
1,082
   
(24
)  
1,058
 
             
Total consideration paid (including contingent consideration
 
originally
estimated at $27,202)
 $
 77,502
  $
24
  $
 77,526
 
             
Page 11

12


Table of Contents

Pro Forma Information
The actual aggregate amortization expense for these intangible assets was $829 and $945following table provides the unaudited consolidated pro forma results for the three months ended March 31, 2019 and 2018, respectively, and $1,658 and $1,883 forperiods presented as if the six months ended March 31, 2019 and 2018, respectively. The estimated aggregate amortization expense for these intangible assets for eachbusiness of GenePOC had been acquired as of the fiscal years through fiscal 2024 is as follows: remainderbeginning of fiscal 2019 – $1,664, fiscal 2020 – $3,165, fiscal 2021 – $2,560, fiscal 2022 – $2,182, fiscal 2023 – $2,170,2019. Pro forma results do not include the effect of any synergies anticipated to be achieved from the acquisition, and fiscal 2024 – $2,166.

accordingly, are not necessarily indicative of the results that would have occurred if the acquisition had occurred on the date indicated or that may result in the future.
 
Three
 
Months
Ended
March 31,
 2019
  
Six
 
Months
Ended
March 31,
 2019
 
Net Revenues
 $
 50,319
  $
 101,871
 
Net Earnings
 $
3,527
  $
7,906
 
These pro forma amounts have been calculated by including the results of GenePOC, and adjusting the combined results to give effect to the following, as if the acquisition had been consummated on October 1, 2018, together with the consequential tax effects thereon:
 
Three Months
Ended
March 31,
 2019
  
Six
 
Months
Ended
March 31,
 2019
 
Adjustments to Net Revenues
      
GenePOC
pre-acquisition
revenues
 $
71
  $
143
 
Adjustments to Net Earnings
      
GenePOC
pre-acquisition
net loss
 $
(3,125
) $
(6,328
)
Pro forma adjustments:
      
Expenses related to
non-continuing
personnel, locations or activities
  
627
   
1,195
 
Incremental depreciation and amortization
  
(872
)  
(1,748
)
Incremental interest costs
  
(254
)  
(538
)
Tax effects of pro forma adjustments
  
57
   
125
 
         
Total Adjustments to Net Earnings
 $
(3,567
) $
(7,294
)
         
6.
4.

Restructuring

During the second quarter of fiscal 2018, the Company began implementation of a plan to realign its business structure into two business units, Diagnostics and Life Science, supported by a global corporate team. AsSince that time and as part of this plan, certain functions and locations within both business units werehave been streamlined, including: (i) the elimination of certain executive management and commercial sales positions; (ii) the closing of Life Science locations in Taunton, Massachusetts and Singapore, the operations of which were transferred to our locations in Memphis, Tennessee and London, England, respectively; and (iii) the transfer of certain functions performed in the Billerica, Massachusetts Diagnostics facility to the corporate headquarters in Cincinnati, Ohio. Further restructuring costs were incurred in fiscal 2019 and the first half of fiscal 2020, as refinements to each business unit’s cost structure continued to be made and the Company incurred severance payment obligations relating to the transition of its previous chief financial officer.
Page 13

As a result of these activities, restructuring costs totaling $6,332$252
,
$527 and
$2,839 were
recorded during the three and six months ended March 31, 2020 and the fiscal year ended September 30, 2018.

During the second quarter of fiscal 2019, approximately $270 of restructuring accrual was reversed and is reflected as a reductionrespectively.

A reconciliation of the Acquisitionchanges in the liabilities associated with the restructuring charges from September 30, 2019 through March 31, 2020 is as follows:
 
Employee
Separation
and
Related
Costs
  
Lease and
Other
Contract
Termination
Fees
  
Other
  
Total
 
Balance at September 30, 2019
 $
1,010
  $
12
  $
114
  $
1,136
 
Restructuring charges
  
482
   
86
   
—  
   
568
 
Reversal of prior period accruals
  
(41
)  
—  
   
—  
   
(41
)
Payments
  
(1,367
)  
(98
)  
(114
)  
(1,579
)
                 
Balance at March 31, 2020
 $
84
  $
 
 
  $
—  
  $
84
 
                 
5.
Cash and Equivalents
Cash and Restructuring Costsequivalents include the following:
 
March 31,
2020
  
September 30,
2019
 
Institutional money market funds
 $
 1,015
  $
 20,913
 
Cash on hand, unrestricted
  
48,535
   
41,484
 
         
Total
 $
 49,550
  $
 62,397
 
         
6.
Inventories
Inventories are comprised of the following:
 
March 31,
2020
  
September 30,
2019
 
Raw materials
 $
9,103
  $
7,455
 
Work-in-process
  
12,856
   
11,504
 
Finished goods - instruments
  
827
   
935
 
Finished goods - kits and reagents
  
18,222
   
19,723
 
         
Total
 $
 41,008
  $
 39,617
 
         
7.
Leasing Arrangements
The Company is party to a number of operating leases, the majority of which are related to office, warehouse and manufacturing space. The related operating lease assets and obligations are reflected within
right-of-use
assets, current operating lease obligations and long-term operating lease obligations on the Condensed Consolidated Balance Sheet. Lease expense for these leases is recognized on a straight-line basis over the lease term, with variable lease payments recognized in the period those payments are incurred. Our Condensed Consolidated
Statements of
Operations for the three months ended March 31, 2020 reflect lease costs for these operating leases
of
$
130
and $
292
within cost of sales and
Page 14

operating expenses, respectively
;
 and
$259 and $559 within cost of sales and operating expenses, respectively, for the six months ended March 31, 2020.
In addition, the Company has periodically entered into other short-term operating leases, generally with an initial term of twelve months or less. These leases are not recorded on the balance sheet and the related lease expense is immaterial for the three and six months ended March 31, 2019. A summary of the accrued liability associated2020.
The Company often has options to renew lease terms, with the restructuring costsexercise of lease renewal options generally at the Company’s sole discretion. In addition, certain lease arrangements may be terminated prior to their original expiration date at our discretion. We evaluate renewal and termination options at the lease commencement date to determine if we are reasonably certain to exercise the option on the basis of economic factors. The weighted average remaining lease term for our operating leases as of March 31, 2020
w
as 4.4 years.
The discount rate implicit within our leases is generally not determinable and, therefore, the Company determines the discount rate
using
its incremental borrowing rate. The weighted average discount rate used to measure our operating leases as of March 31, 2020
was 3.7%.
Supplemental cash flow information related to the Company’s operating leases are as follows:
  Three Months  Six Months 
 
Ended March 31,
  
Ended March 31,
 
 
2020
  
2019
  
2020
  
2019
 
Cash paid for amounts included in the measurement of lease
 
liabilities:
            
Operating cash flows from operating leases
 $
391
  $
  $
778
  $
 
                 
Maturities of lease liabilities by fiscal year for the Company’s operating lease liabilities were as follows as of March 31, 2020:
 
March 31,
2020
 
Remainder of 2020
 $
 768
 
2021
  
1,515
 
2022
  
1,302
 
2023
  
943
 
2024
  
692
 
Thereafter
  
600
 
     
Total lease payments
  
5,820
 
Less amount of lease payment representing interest
  
(359
)
     
Total present value of lease payments
 $
 5,461
 
     
Page 15

As of September 30, 2019, future minimum lease payments under noncancelable operating leases were as follows:
 
September 30,
2019
 
2020
 $
 1,528
 
2021
  
1,451
 
2022
  
1,293
 
2023
  
967
 
2024
  
712
 
Thereafter
  
616
 
     
Total
 $
 6,567
 
8.
Intangible Assets
In light of the economic impacts of
COVID-19,
the Company performed a review of the assets on our consolidated balance sheet as of March 31, 2020, including goodwill, intangible and other long-lived assets. Based on our review, we do not believe that a triggering event exists at this time and, therefore, we believe that we will be able to realize the full value of our assets. As such, no impairments or other write-downs related to
COVID-19
have been recorded during fiscal 2020. Our assessment was based on information currently available and relies on various assumptions based on estimates of future cash flows and the probability of achieving the estimated cash flows. Future changes in market, economic or other conditions may lead to impairments in the future.
A summary of our acquired intangible assets subject to amortization, as of March 31, 2020 and September 30, 2018,2019, is as follows:

   March 31,
2019
   September 30,
2018
 

Severance, other termination benefits and related costs

  $78  $987

Lease and other contract termination fees

   —     33

Other

   —     6
  

 

 

   

 

 

 

Total

  $78  $1,026
  

 

 

   

 

 

 

7.

Income Taxes

On December 22, 2017, the United States enacted tax reform legislation commonly known as the Tax Cuts

                 
 
 
March 31, 2020
  
September 30, 2019
 
 
 
Gross
Carrying
Value
  
Accumulated
Amortization
  
Gross
Carrying
Value
  
Accumulated
Amortization
 
Manufacturing technologies, core products and cell lines
 $
56,188
  $
16,838
  $
56,193
  $
15,096
 
Trade names, licenses and patents
  
14,499
   
6,851
   
14,494
   
6,094
 
Customer lists, customer relationships and supply agreements
  
24,285
   
14,720
   
24,274
   
14,110
 
Government grants
  
759
   
474
   
814
   
232
 
                 
Total
 $
95,731
  $
38,883
  $
95,775
  $
35,532
 
                 
The actual aggregate amortization expense for these intangible assets was $1,727 and Jobs Act (the “tax reform act”). In applying the tax reform act during the three months ended December 31, 2017, we followed the guidance in SEC Staff Accounting Bulletin 118 (“SAB 118”), regarding the application of ASC Topic 740 in situations where a company does not have the necessary information available, prepared or analyzed in reasonable detail to complete the accounting for certain income tax effects of the tax reform act for the reporting period in which the tax reform act was enacted. SAB 118 provides for a measurement period beginning in the reporting period that includes the tax reform act’s enactment date and ending when a company has obtained, prepared and analyzed the information needed in order to complete the accounting requirements, but in no circumstances should the measurement period extend beyond one year from the enactment date.

As a result, our financial statements$829 for the three months ended DecemberMarch 31, 2017 reflected2020 and 2019, respectively, and $3,449 and $1,658 for the effectssix months ended March 31, 2020 and 2019, respectively. The estimated aggregate amortization expense for these intangible assets for each of the tax reform actfiscal years through fiscal 2025 is as provisional based on a reasonable estimatefollows: remainder of fiscal 2020 – $3,306, fiscal 2021 – $5,490, fiscal 2022 – $5,113, fiscal 2023 – $5,100, fiscal 2024 – $5,096, and fiscal 2025 – $5,096.

9.
Bank Credit Arrangements
In anticipation of the income tax effects and included a provisional noncurrent income tax payable in the amount of $854 related to the repatriation transition tax. Subsequent to the quarter ended December 31, 2017 and prior to September 30, 2018, we completed the accounting for the effectsacquisition of the tax reform act. As a result, our repatriation transition tax liability was increased to $876, which is reflected as follows in the accompanying Condensed Consolidated Balance asbusiness of March 31,GenePOC (see Note 3), on May 24, 2019 after our having recently paid the amount estimated for fiscal 2018: $65 of current income taxes payable and $736 long-term income taxes payable.

Page 12


In addition, during the three months ended December 31, 2017 we recorded aone-time tax benefit of $1,695 resulting from the tax reform act, including an adjustment from there-measurement of deferred tax assets and liabilities. Thisre-measurement included an estimate of the temporary differences expected to be realized during fiscal 2018 at a transitional blended rate of 24.5%. The remaining temporary differences werere-measured at 21%.

8.

Bank Credit Arrangements

In March 2016, the Company entered into a $60,000 five-year term loancredit facility agreement with a commercial bank.bank

. The term loan requires quarterlyCompany amended the credit facility agreement
on February 19, 2020 in anticipation of the Company’s pending acquisition of Exalenz Bioscience Ltd. (see Note 12). The credit facility expires in May 2024, and as amended makes available to the Company a revolving credit facility in an aggregate principal amount not
to exceed
 $
160,000
 (originally $125,000), with outstanding principal amounts
Page 16

Table of Contents
bearing interest at a fluctuating rate tied to, at the Company’s option, either the federal funds rate or LIBOR, resulting in an effective
interest rate of 4.15%
and 4.04% on the credit facility during the three and six months ended March 31, 2020, respectively.
Since entering into the credit facility through March 31, 2020
, two draws totaling
$75,824 
have been made on the credit facility, with a January 2020 principal repayment resulting in an outstanding principal balance of $48,824 at March 31, 2020
 (see Note 12 for activity subsequent to quarter-end)
. The proceeds from these draws were used to: (i) repay and settle the outstanding principal and interest payments,due on our previously existing $60,000 five-year term loan; and (ii) along with interest at a variable rate tied to LIBOR, and a balloon principal payment due March 31, 2021. The required principal payments oncash
on-hand,
fund the term loan for each of the remaining fiscal years are as follows: remainder of fiscal 2019 - $3,000, fiscal 2020 - $6,000, and fiscal 2021 - $39,000.GenePOC acquisition closing payment. In light of the term loan’s interest being determined on a variable rate basis, the fair value of the term loanborrowings under the credit facility at
March
 31, 20192020 approximates the current carrying value reflected in the accompanying Condensed Consolidated Balance Sheet.

Sheet

.
The revolving credit facility is collateralized by the business assets of the Company’s U.S. subsidiaries and requires 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 credit facility agreement. As of March 31, 2020, the Company is in compliance with all covenants.
In order to limit exposure to volatility in the LIBOR interest rate, during March 2020 the Company and the commercial bank also entered into antwo interest rate swap agreements that will effectively convertsconvert the variable interest rate on $25,000 of the term loanoutstanding principal to a fixed rate of 2.76%.2.31%
(
at the current credit spread
)
beginning May 24, 2020, the effective date of the swap agreements. With an initial notional balance of $60,000,$25,000, the interest rate swap wasagreements were established with critical terms identical to thoseborrowings under the credit facility, including: (i)
 one-month
LIBOR settlement rates, as to be elected by the Company throughout the remaining term of the term loan, including: (i) notional reduction amounts and dates;credit facility; (ii) LIBOR settlement rates; (iii) rate reset dates; and (iv)(iii) term/maturity. Due to this,
Consequently
, the interest rate swap hasswaps have been designated as an effective cash flow hedge,hedges, with changes in fair value
values
reflected as a separate component of other comprehensive income in the accompanying Condensed Consolidated Statements of Comprehensive Income. At March 31, 2019 and September 30, 2018,2020, the fair value of the interest rate swap swaps
was $835 and $1,722, respectively, andreported as
a liability of $313, which is reflected as a
non-current asset
liability in the accompanying Condensed Consolidated Balance Sheets.Sheet. This fair value was determined by information provided by the counterparty and is considered a Level 2 input within the fair value hierarchy of valuation techniques.

In addition,connection with the Company’s term loan repayment in May 2019, the Company maintainsalso settled the interest rate swap that had been entered into to limit exposure to volatility in the term loan’s LIBOR interest rate. At the time of settlement, the Company received a $30,000 revolvingcash payment in an amount equal to the 
 $563
then-current fair value of the interest rate swap. Accordingly, there is no balance for this interest rate swap reflected within assets or liabilities within the accompanying Consolidated Balance Sheets as of March 31, 2020 or September 30, 2019. The fair value of the swap that had been reflected within a separate component of other comprehensive income in the accompanying Consolidated Statements of Comprehensive Income, as a result of the interest rate swap having been designated as an effective cash flow hedge, is being released ratably into income through March 31, 2021, the interest rate swap’s original term. 
The balance reflected within accumulated other comprehensive income related to the interest rate swap agreements associated with both the current credit facility with a commercial bank, which expires March 31, 2021. There were no borrowings outstanding on this credit facilityand the former term loan totaled ($6
)
and $461 at March 31, 2019 or2020 and September 30, 2018.

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, 2019, the Company is in compliance with all covenants. The Company is also required to maintain a compensating cash balance with the bank in the amount of $1,000, and is in compliance with this requirement.

See Note 12,“Subsequent Event”.

respectively.
9.10.

Reportable Segments and Major Customers Information

Meridian was formed in 1976 and functions as a fully-integrated life science company with principal businesses in: (i) the development, manufacture, sale and distribution of diagnostic test kits, primarily for certain gastrointestinal and respiratory infectious diseases, and elevated blood lead levels; and (ii) the manufacture and distribution of bulk antigens, antibodies, PCR/qPCR reagents, nucleotides, competent cells, and bioresearch reagents used by researchers and other diagnostic manufacturers.

Our reportable segments are Diagnostics and Life Science. The Diagnostics segment consists of manufacturing operations for infectious disease products in Cincinnati, Ohio and Quebec City, Canada, manufacturing operations for blood chemistry products 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 in blood.

Page 17

The Life Science segment consists of manufacturing operations in Memphis, Tennessee; Boca Raton, Florida; London, England; and Luckenwalde, Germany, 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 facility in Beijing, China to further pursue 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).

Page 13


Amounts due from two2 Diagnostics distributor customers accounted for 14% and 12%13% of consolidated accounts receivable at

both
March 31, 20192020 and September 30, 2018, respectively.2019. Revenues from these two2 distributor customers accounted for 25%23% and 27%25% of the Diagnostics segment third-party revenues during the three months ended March 31, 20192020 and 2018,2019, respectively, and
 25% and
30% during each of the six
-
month periods ended March 31, 20192020 and 2018.2019
, respectively
. These distributors represented 17%14% and 19%17% of consolidated revenues for the fiscal 20192020 and 20182019 second quarters, respectively, and
 17% and
21% for each of the respective
year-to-date
six
-
month periods.

Within our Life Science segment, two diagnostic manufacturing customers accounted for 27%17% and 22%27% of the segment’s third-party revenues during the three months ended March 31, 20192020 and 2018,2019, respectively, and 27%16% and 19%27% during the six months ended March 31, 2020 and 2019, and 2018, respectively.

Segment information for the interim periods is as follows:

   Diagnostics   Life Science   Corporate(1)  Eliminations(2)  Total 

Three Months Ended March 31, 2019

 

Net revenues -

        

Third-party

  $33,500  $16,748  $—    $—    $50,248

Inter-segment

   89   53   —    (142  —  

Operating income

   7,561   5,361   (3,101  14   9,835

Goodwill (March 31, 2019)

   35,213   19,429   —    —    54,642

Other intangible assets, net (March 31, 2019)

   20,705   747   —    —    21,452

Total assets (March 31, 2019)

   183,234   70,152   —    578   253,964

Three Months Ended March 31, 2018

        

Net revenues -

        

Third-party

  $39,782  $16,669  $—    $—    $56,451

Inter-segment

   80   75   —    (155  —  

Operating income

   10,684   3,638   (6,723  79   7,678

Goodwill (September 30, 2018)

   35,213   19,424   —    —    54,637

Other intangible assets, net (September 30, 2018)

   22,068   1,045   —    —    23,113

Total assets (September 30, 2018)

   180,978   70,341   —    58   251,377

Six Months Ended March 31, 2019

 

Net revenues -

        

Third-party

  $70,165  $31,563  $—    $—    $101,728

Inter-segment

   252   229   —    (481  —  

Operating income

   16,346   10,492   (6,493  41   20,386

Six Months Ended March 31, 2018

 

Net revenues -

        

Third-party

  $77,272  $31,462  $—    $—    $108,734

Inter-segment

   201   267   —    (468  —  

Operating income

   19,310   6,580   (10,334  183  15,739

  Diagnostics  Life Science  
Corporate
(1)
  
Eliminations
(2)
  Total 
Three Months Ended March 31, 2020
 
Net revenues -
               
Third-party
 $
34,942
  $
 22,354
  $
 
 
 
 
 
 
 
 
—  
  $
—  
  $
57,296
 
Inter-segment
  
81
   
55
   
—  
   
(136
)  
—  
 
Operating income
  
3,842
   
10,818
   
(2,896
)  
27
   
11,791
 
Goodwill (March 31, 2020)
  
70,317
   
18,881
   
—  
   
—  
   
89,198
 
Other intangible assets, net (March 31, 2020)
  
56,681
   
167
   
—  
   
—  
   
56,848
 
Total assets (March 31, 2020)
  
245,059
   
74,036
   
—  
   
(21
)  
319,074
 
                     
Three Months Ended March 31, 2019
               
Net revenues -
               
Third-party
 $
33,500
  $
 16,748
  $
—  
  $
—  
  $
50,248
 
Inter-segment
  
89
   
53
   
—  
   
(142
)  
—  
 
Operating income
  
6,676
   
5,361
   
(2,216
)  
14
   
9,835
 
Goodwill (September 30, 2019)
  
70,395
   
18,846
   
—  
   
—  
   
89,241
 
Other intangible assets, net (September 30, 2019)
  
59,807
   
436
   
—  
   
—  
   
60,243
 
Total assets (September 30, 2019)
  
255,169
   
70,392
   
—  
   
(83
)  
325,478
 
                     
Six Months Ended March 31, 2020
 
Net revenues -
               
Third-party
 $
69,733
  $
34,984
  $
—  
  $
—  
  $
 
104,717
 
Inter-segment
  
178
   
120
   
—  
   
(298
)  
—  
 
Operating income
  
8,250
   
13,879
   
(4,983
)  
39
   
17,185
 
                     
Six Months Ended March 31, 2019
 
Net revenues -
               
Third-party
 $
70,165
  $
31,563
  $
—  
  $
—  
  $
101,728
 
Inter-segment
  
252
   
229
   
—  
   
(481
)  
—  
 
Operating income
  
15,374
   
10,492
   
(5,521
)  
41
   
20,386
 
                     
(1)

Includes Acquisition, Restructuring Costs and LitigationSelected Legal Costs
of $1,488$685 and $4,911$603 in
the three months ended March 31, 2020 and 2019, respectively,
and
$1,055 and 2018, respectively, and $2,164 and $6,394$1,192 in the
six months ended March 31,
2020 and 2019, and 2018, respectively.

(2)

Eliminations consist of inter-segment transactions.

Page 18

Table of Contents
A reconciliation of segment operating income to consolidated earnings before income taxes for the three
and six months ended March 31, 2020 and 2019 is as follows:
                 
  Three Months  Six Months 
  Ended March 31,  Ended March 31, 
  2020  2019  2020  2019 
Segment operating income
 $
14,687
  $
12,051
  $
22,168
  $
25,907
 
Corporate
operating
expenses
  
(2,896
)  
(2,216
)  
(4,983
)  
(5,521
)
Interest income
  
23
   
204
   
134
   
353
 
Interest expense
  
(532
)  
(347
)  
(1,299
)  
(710
)
Other, net
  
1,365
   
(445
)  
653
   
(306
)
                 
Consolidated earnings before income taxes
 $
12,647
  $
9,247
  $
16,673
  $
19,723
 
                 
Transactions between segments are accounted for at established intercompany prices for internal and management purposes, with all intercompany amounts eliminated in consolidation.

Page 14


10.11.

Litigation Matters

On November 15, 2017, Barbara Forman filed a class action complaint in the United States District Court for the Southern District of Ohio (the Court) naming Meridian, its former Chief Executive Officer and former Chief Financial Officer (in their capacities as such) as defendants. An amended complaint was filed on April 16, 2018 and the Company believes the essential elements of the amended complaint are the same. The complaint andOn July 9, 2019, a settlement was reached with the amended complaint are hereafter referred to asplaintiff that provides for a $2,100 payment by the “Complaint”. The Complaint seeks compensatory damages and attorneys’ fees.Company. On February 13,October 9, 2019, the Court granted Meridian’sa motion to dismissfor preliminary approval of the settlement, and dismissedon November 7, 2019, the Complaint in its entirety. Plaintiff filedsettlement amount was paid from the Company’s directors and officers insurance policy into a Motion to Reconsider, Set Aside, Alter, Amend, or Vacate the Judgment of dismissalplaintiff escrow account.
After
a final approval hearing
on
March
16,
2020
, on March 13, 2019. Meridian opposed17, 2020, the Plaintiff’s motion on April 3, 2019Court issued an order and judgment approving the Plaintiff filedsettlement
.
Because the settlement was a reply on April 17, 2019. The motion remains pending before the Court. Accordingly,covered claim under our directors and officers insurance policy, no provision for litigation losses has been included within either of  the accompanying Condensed Consolidated Statements of Operations for the three and six months ended March 31, 20192020 or March 31, 2018.

2019.

On December 6, 2017, Michael Edelson filed a derivative complaint in the United States District Court for the Southern District of Ohio naming Meridian, its former Chief Executive Officer, former Chief Financial Officer and certain members of Meridian’s Board of Directors and Audit Committee (in their capacities as such) as defendants. The complaint alleges that Meridian made false and misleading representations concerning certain of Magellan’s lead test systems at or around the time of Meridian’s acquisition of Magellan and subsequent thereto, and the complaint alleges that certain members of the Board of Directors and Audit Committee breached their fiduciary duties in their oversight of the Company’s public disclosures and corporate governance matters. The complaint seekssought compensatory damages, equitable relief relating to corporate governance matters and attorneys’ fees. The case has been stayed by agreement ofOn October 9, 2019, the parties pending resolution of theCourt granted plaintiff’s motion to dismiss the class action described above. We are unable to determine or predict the ultimate outcome or estimate the range of possible losses, if any. for voluntary dismissal.
Accordingly, no provision for litigation losses has been included within either of the accompanying Condensed Consolidated Statements of Operations for the three and six months ended March 31, 2019 or March 31, 2018.

Approximately $40 of expense for attorneys’ fees related to the above two class action matters is included within the accompanying Condensed Consolidated Statements of Operations for both the three and six months ended March 31, 2019, with approximately $530 and $545 of related expense being reflected within the accompanying Condensed Consolidated Statements of Operations for the three and six months ended March 31, 2018, respectively. The Company maintains an insurance policy covering these matters, which has a $500 deductible.

2020 or March 31, 2019.

On April 17, 2018, Meridian’s wholly-owned subsidiary, Magellan Diagnostics, Inc. received a subpoena from the United States Department of Justice (“DOJ”) regarding its LeadCare product line. The subpoena outlines documents to be produced, and the Company is cooperating with the DOJ in this matter. The Company maintains rigorous policies and procedures to promote compliance with applicable regulatory agencies and requirements, and is working with the DOJ to promptly respond to the subpoena, including responding to additional information requests and executing a requests. The Company has executed
multiple
tolling agreementagreements to extend the statute of limitations. However, theThe Company cannot predict when the investigation will be resolved, the outcome of the investigation, or its potential impact on the Company. Approximately $560$725 and $1,100$560 of expense for attorneys’ fees related to this matter is included within the accompanying Condensed Consolidated Statements of Operations for the three months ended March 31
, 2020
and March 31
, 2019
, respectively; approximately $1,005
and $1,100
for the six months ended March 31 2019, respectively, with no related expense being reflected within the accompanying Condensed Consolidated Statements of Operations for the three
, 2020
and six months ended March 31 2018.

On October 9, 2018, the Company and DiaSorin Inc. entered into a strategic collaboration to sell DiaSorin’sHelicobacter pylori stool antigen test to detectH. pylori for use on its automated LIAISON platform under the Meridian brand name worldwide. The new collaboration results in the termination

, 2019
, respectively.
Page 19

Table of all pending legal disputes between the two parties and will expand the previous agreement between DiaSorin and Meridian, which focused on the sale, by DiaSorin, ofco-developed products in major countries in continental Europe. Approximately $0 and $50 of expense for attorneys’ fees related to this matter is included within the accompanying Condensed Consolidated Statements of Operations for the three and six months ended March 31, 2019, respectively, and approximately $925 and $1,655 of related expense is included within the accompanying Condensed Consolidated Statements of Operations for the three and six months ended March 31, 2018, respectively.

Page 15

Contents


11.

FDA Matters Related to LeadCare

As previously disclosed, on June 29, 2017, the FDA, in connection with its Safety Notification related to Magellan’s LeadCaretesting systems for venous blood samples, issued to Magellan its Form 483, Inspectional Observations. The FDA issued a related Warning Letter on October 23, 2017. As also previously disclosed, on April 17, 2018, Magellan received a subpoena from the United States Department of Justice (“DOJ”) regarding its LeadCare product line. The subpoena outlines documents to be produced, and we continue to cooperate with the DOJ in this matter, including responding to additional information requests and executing a tolling agreement to extend the statute of limitations.

Magellan submitted 510(k) applications in December 2018, seeking to reinstate venous blood sample-types for its LeadCare® II, LeadCare® Plus and LeadCare Ultra® testing systems. In the second fiscal quarter of 2019 the FDA informed Magellan that each of these 510(k) applications has been put on Additional Information hold. Further, while Magellan’s LeadCare testing systems remain cleared for marketing by the FDA and permitted for use with capillary blood samples, the FDA advised that it has commissioned a third-party study of Magellan’s LeadCare testing systems using both venous and capillary blood samples. According to the FDA, the results of the field study will be used in conjunction with other information to determine whether further action by FDA or the Centers for Disease Control and Prevention is necessary to protect the public health. Meridian intends to fully cooperate with the FDA as FDA completes its third-party study and continues to work to complete remediation actions at Magellan’s blood–chemistry manufacturing facility to the FDA’s full and complete satisfaction.

While we remain confident in the performance of the Magellan LeadCare testing systems, there can be no assurance that the ongoing investigation and study of the DOJ and FDA, respectively, or future exercise of their respective enforcement, regulatory, discretionary or other powers will not result in findings or alleged violations of federal laws that could lead to enforcement actions, proceedings or litigation and the imposition of damages, fines, penalties, restitution, other monetary liabilities, sanctions, settlements or changes to our business practices, product offerings or operations that could have a material adverse effect on our business, financial condition or results of operations; or eliminate altogether our ability to operate our lead testing business, or on terms substantially similar to those on which we currently operate.

See Part II, Item 1A Risk Factors below.

12.

Subsequent Event

Even
ts

On 
April 29, 2019, we signed a definitive agreement to acquire substantially 30
, 2020, the Company acquired
all of the assets, as well as selected liabilities,outstanding capital stock of GenePOC Inc.
Exalenz Bioscience Ltd. (“Exalenz”), a molecular diagnostics company locatedmanufacturer of a urea breath diagnostic testing platform headquartered in Quebec City, Quebec Province, Canada.Modi’in, Israel, for approximately $48,000
in cash. In addition, the Company paid approximately $8,000 in cash for Exalenz to repay two bank loans
. During 2019, Exalenz generated approximately $14,000 of revenue from sales of its BreathID
®
Breath Test Systems. This purchase will be included in our Diagnostics operating segment. The maximum purchase price is $120,000, which consists of: (i) $50,000 to be paid at closing (subject tosegment
 and accounted for as a working capital adjustment and a $5,000 hold-back to secure seller’s post-closing obligations); (ii) up to $20,000 to be paid in fiscal 2021, contingent upon the achievement of product development milestones; and (iii) up to $50,000 to be paid in fiscal 2023 based on certain sales and profit margin thresholds to be measured in fiscal 2022. GenePOC’s molecular diagnostics testing system is branded under the name revogene, and currently includes threeFDA-cleared assays (C. difficile, Group A Strep and Group B Strep). The purchase is expected to close no later than early fourth quarter fiscal 2019, pending the satisfaction of certain closing conditions.

business combination. In connection with the proposedmerger consideration for the acquisition and repayment of GenePOC, we also expect to executethe Exalenz bank loans, the Company executed two forward contracts with a new five-year $125,000total notional amount of 187,000 New Israeli Shekels, both of which settled on April 20, 2020

.
In anticipation of the Exalenz acquisition, in April 2020, an additional $50,000 was drawn on the revolving credit facility, that would replace our existing $30,000 credit facility. We expectresulting in an outstanding principal balance of $98,424 as of the new credit facility will be secured by substantially alldate of our assets and will include certain restrictive financial covenants. We expect to draw down approximately $73,000 from this new facility and use approximately $20,000 of cashon-hand to repay the existing term loan outstanding at March 31, 2019 and fund the closing payment for the acquisition of GenePOC.

Also, our Board of Directors suspended the declaration and payment of quarterly dividends by Meridian to invest in new product development activities for the revogene molecular diagnostics platform, among other investments in the business, and to preserve our capital resources and liquidity for general corporate purposes.

Page 16

filing.


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

The purpose of Management’s Discussion and Analysis is a discussion and analysis of the financial statements and other statistical data that management believes will enhance theto provide an understanding of Meridian’s financial condition, changes in financial condition and results of operations. Unless otherwise noted, increases or decreases are measured over the corresponding period of the prior fiscal year. This discussion should be read in conjunction with the financial statements and notes thereto beginningnotes.
Impact of
COVID-19
Pandemic
In December 2019, the SARS-CoV-2 virus emerged in Wuhan, China and spread to other parts of the world. In March 2020, the World Health Organization (“WHO”) designated
COVID-19
(the disease caused by SARS-CoV-2) a global pandemic. Governments have implemented lockdown and
shelter-in-place
orders, requiring many
non-essential
businesses to shut down operations for the time being. Our business, however, is deemed “essential” and has continued to operate and manufacture and distribute products to customers globally. We have developed a comprehensive plan that enables us to maintain operational continuity with an emphasis on page 1.

manufacturing, product distribution and new product development during this crisis. We continually assess

COVID-19
related developments and adjust risk mitigation planning and business continuity activities as needed.
Employee Safety
In
mid-March
2020, we instituted a work from home process for employees whose on-site presence is designated as
non-essential
to the ongoing function of our manufacturing site, distribution centers, and new product development facilities. We have implemented enhanced cleaning and sanitizing procedures, and provided additional personal hygiene supplies at all of our sites. We have implemented policies for employees to adhere to the Centers for Disease Control and Prevention (“CDC”) guidelines on social distancing and any employees experiencing any symptoms of
COVID-19
are required to stay home and seek medical attention. Any employee who tests positive for
COVID-19
is required to quarantine and is not allowed to return to our facilities without a physician’s release. We have closed our facilities to outside persons who are not critical to continuing our operations. To date, we have been able to manufacture and distribute products globally, and our sites continue to operate without interruption. As the pandemic continues to spread over time, there is an increased risk of employee absenteeism, which could materially impact our operations at one or more sites. To date, our work from home processes have not materially impacted the Company’s financial reporting systems, internal controls over financial reporting or disclosure controls.
Supply Chains
Currently and as anticipated for the near future, our supply chains supporting our products remain intact, providing access to sufficient inventory of the key materials needed for manufacturing. To date, delays and allocations for certain raw materials of higher demand have been limited, and have not had a material impact on our results of operations. We are regularly communicating with our suppliers, third-party partners, customers, health care providers
Page 20

and government officials in order to respond rapidly to issues as they arise. The longer the current situation continues, it is more likely that we may experience some sort of interruption to our supply chains, and such an interruption could materially affect our ability to timely manufacture and distribute our products and unfavorably impact our results of operations.
Clinical Trial Delays
As a result of the pandemic, certain clinical trials which were underway or scheduled to begin have been temporarily placed on hold. Such delays will impact our timing for filing applications for product clearances with the FDA, as well as related timing of FDA clearances of such filings. Additionally, the pandemic could slow down our efforts to expand our product portfolio through acquisitions and distribution opportunities, impacting the speed with which we are able to bring additional products to market.
Product Demand
Our Life Science segment manufactures, markets and sells a number of immunoassay and molecular reagents to IVD customers, including those who are making both molecular and immunoassay
COVID-19
tests. During our second quarter of fiscal 2020, we began seeing unprecedented demand for certain of our molecular reagents (e.g., ribonucleic acid (“RNA”) master mixes and nucleotides), and such demand has continued into our third fiscal quarter. Although we are unable to predict when this demand may subside, we expect materially higher revenue levels for these products during the next three to six months. These products are currently being used by over 35 IVD companies around the world in the development of
COVID-19
molecular tests. In addition, during April we announced the launch of several recombinant antigens critical for the development of antibody tests for
COVID-19.
Based upon the launch of these immunological reagent products and the strong demand for molecular reagent products noted above, we are currently expecting third quarter Life Science revenues of at least double that of normal quarterly levels.
Our Diagnostics segment manufactures, markets and sells a number of molecular, immunoassay and blood chemistry assays for various infectious diseases and blood-lead levels. We expect near-term sales volumes for a number of these assays to be adversely affected by the
COVID-19
pandemic as such assays are often used in
non-critical
care settings. In addition, the
COVID-19
pandemic has greatly slowed our instrument placements as diagnostic testing sites have turned their attention to critical care testing. During the month of April, our weekly shipments of Diagnostic products were approximately 50% of expected volume levels. Given the nature of our diagnostic assays (i.e., infectious disease and blood-lead), we expect to return to expected sales volume levels within three to six months assuming shelter in place orders relax and health care facilities return to normal,
pre-pandemic
operations in the near term. However, no assurances can be made in this regard.
Asset Impairment Review
In light of the economic impacts of
COVID-19,
the Company performed a review of the assets on our consolidated balance sheet as of March 31, 2020, including intangible and other long-lived assets. Based on our review, we do not believe that a triggering event exists at this time and, therefore, we believe that we will be able to realize the full value of our assets. As such, no impairments or other write-downs related to
COVID-19
were recorded during fiscal 2020. Our assessment was based on information currently available and relies on various assumptions based on estimates of future cash flows and the probability of achieving the estimated cash flows. Future changes in market, economic or other conditions may lead to future impairments.
Access to Capital
As of March 31, 2020, the Company’s outstanding debt balance on its revolving credit facility was $48,824. The impacts of
COVID-19
have adversely affected the capital markets and the ability of many companies to access capital and liquidity on favorable terms or at all. The Company believes it has sufficient liquidity and cash flows to meet its operating and debt service requirements for at least the next twelve months. We drew $50,000 on our revolving credit facility in April to complete the acquisition of Exalenz Bioscience Ltd. (“Exalenz”) described in Note 12, “
Subsequent Events”
of the accompanying condensed consolidated financial statements. The Company expects to be in compliance with its financial covenants during the same period. However, the Company is currently unable to predict the impact that
COVID-19
will have on its ability to access capital in the future. If the Company is unable to access additional capital and liquidity on acceptable terms, it could adversely impact the Company’s results of operations and ability to meet its future obligations beyond the next twelve months.
Page 21

Based on the foregoing, the Company cannot reasonably predict the extent of the impact of
COVID-19
on our future results of operations and cash flows due to the continued uncertainty around the duration and severity of the pandemic. The
COVID-19
situation is changing rapidly and future impacts may materialize that are not yet known.
RESULTS OF OPERATIONS

Three and Six Months Ended March 31, 2019

2020

Net earnings for the second quarter of fiscal 20192020 increased 34%32% to $7,094,$9,359, or $0.17$0.22 per diluted share, from net earnings for the second quarter of fiscal 20182019 of $5,288,$7,094, or $0.12$0.17 per diluted share. For the
six-month
period ended March 31, 2020, net earnings were $12,186, or $0.28 per diluted share. The fiscal 2019level of net earnings in the second quarter results include $1,388(“QTD”) and first six months (“YTD”) of costs associated with acquisition and restructuring activities, and litigation costs, whilefiscal 2020 were affected by several factors, including most notably the fiscal 2018 second quarter results include $4,911combined effects of costs associated with restructuring activities and litigation costs. These items hadthe following (amounts presented on a combined impact on net earnings of $1,065, or $0.02 per diluted share, in the fiscal 2019 quarter and $3,575, or $0.08 per diluted share, in the fiscal 2018 quarter (see “USE OFNON-GAAP MEASURES” below).
pre-tax
basis):
(i)significantly higher revenue in the Life Science operating segment, due in large part to supplying key molecular components to diagnostic test manufacturers for use in
COVID-19
related tests;
(ii)higher research and development spending in the Diagnostics segment ($1,618 QTD; $2,731 YTD);
(iii)increased cash-based incentive compensation ($2,045 QTD; $2,570 YTD);
(iv)increased intangible asset amortization, primarily resulting from purchase accounting amortization related to the acquisition of the GenePOC business in June 2019 ($825 QTD; $1,715 YTD);
(v)increased acquisition-related costs in connection with the fiscal 2020 Exalenz transaction, as compared to those related to the GenePOC transaction in fiscal 2019 ($902 QTD; $815 YTD);
(vi)a decrease in the fair value of the earnout obligation for the acquisition of the GenePOC business ($2,491 QTD; $1,304 YTD); and
(vii)significantly higher gains related to foreign currency, particularly as it relates to the British pound sterling ($1,704 QTD; $643 YTD).
Consolidated revenues for the second quarter of fiscal 20192020 totaled $50,248, a decrease$57,296, an increase of 11%14% compared to the second quarter of fiscal 2018 (10% decrease2019 (15% increase on a constant-currency basis).

Revenues for the Diagnostics segment for the second quarter of fiscal 2019 decreased 16%2020 increased 4% compared to the second quarter of fiscal 2018 (15%2019 (5% increase on a constant-currency basis), comprised of a 29% decrease2% increase in molecular assay products and a 12% decrease5% increase in immunoassay and blood chemistry assay products. As previously noted, the
COVID-19
pandemic dramatically slowed the placement of our molecular assay products during the quarter, resulting in 35 Revogene
®
systems being installed during the second quarter of fiscal 2020 and a total Revogene system install base of 148 systems as of March 31, 2020. With a 12% decrease114% increase in its molecular reagents products and an 8% increasea 5% decrease in its immunological reagents products, revenues for our Life Science segment were flatincreased 33% during the second quarter of fiscal 20192020 compared to the second quarter of fiscal 2018.2019. On a constant-currency basis, revenues for the Life Science segment increased 2%34%.

The second quarter Diagnostics revenues reflect modest growth in our blood chemistry assay product line being more than offset by decreased revenues for our gastrointestinal and respiratory assays. Life Science revenues reflect inconsistent buying patterns with a number of our multi-national IVD manufacturing customers and general market softness in China.

Six Months Ended March 31, 2019

For the six month period ended March 31, 2018, net earnings were $15,200, or $0.35 per diluted share. Theyear-to-date fiscal 2019 results include $2,064 of costs associated with acquisition and restructuring activities, and litigation costs, while the comparable fiscal 2018 results include $6,394 of costs associated with restructuring activities and litigations costs, along with certainone-time tax effects of the U.S. tax reform act enacted in December 2017. These items had a combined impact on net earnings of $1,583, or $0.04 per diluted share,significant increase in the fiscal 2019year-to-date periodsales of key molecular components such as RNA master mixes and $3,814, or $0.09 per diluted share,deoxyribonucleotide triphosphates (“dNTPs”) to diagnostic test manufacturers for use in the comparable fiscal 2018 period (see “USE OFNON-GAAP MEASURES” below).

COVID-19
related tests, including a fourfold increase in revenue from sales into China.
Consolidated revenues decreased 6%increased 3% to $101,728$104,717 for the first six months of fiscal 20192020 compared to the same period of the prior year (also 6%3% on a constant-currency basis). On an operating segment basis, Diagnostics revenues decreased 9% (also 9% in constant-currency)1% (flat on a constant-currency basis) and Life Science revenues were flat (2%increased 11% (12% increase in constant-currency).

Page 17


USE OFNON-GAAP MEASURES

We have supplemented our reported GAAP financial information with information on operating expenses, operating income, net earnings, basic earnings per share and diluted earnings per share excluding the effects of: (i) acquisition transaction costs (fiscal 2019); (ii) restructuring costs (fiscal 2019 and 2018); (iii) litigation costs (fiscal 2019 and 2018); and (iv) certainone-time tax effects of the tax reform act (fiscal 2018) – each of which is anon-GAAP measure. We have provided in the tables below reconciliations to the operating expenses, operating income, net earnings, basic earnings per share and diluted earnings per share amounts reported under U.S. Generally Accepted Accounting Principles. We believe that this information is useful to those who read our financial statements and evaluate our operating results because:

1)

These measures help to appropriately evaluate and compare the results of operations from period to period by removing the impacts of thesenon-routine items; 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.

Revenue reported on a constant-currency basis is alsobasis).

Lead Testing Matters 
On June 29, 2017, the United States Food and Drug Administration (“FDA”), in connection with its Safety Notification related to Magellan’s LeadCare testing systems for venous blood samples, issued to Magellan its Form 483, Inspectional Observations. The FDA issued anon-GAAP measure related Warning Letter on October 23, 2017. On April 17, 2018, Magellan received a subpoena from the United States Department of Justice (“DOJ”) regarding its LeadCare product line. The subpoena outlines documents to be produced, and is calculated by applying current period average foreign currency exchange rateswe continue to cooperate with the DOJ in this matter, including responding to additional information requests. We have executed multiple tolling agreements to extend the statute of limitations.
Page 22

Table of Contents
Magellan submitted 510(k) applications in December 2018, seeking to reinstate venous blood sample-types for its LeadCare
®
II, LeadCare
®
Plus
and LeadCare Ultra
®
testing systems. In the second fiscal quarter of 2019 the FDA informed Magellan that each of these 510(k) applications had been put on Additional Information hold. On July 15, 2019, we provided responses to the prior comparable periods. Management analyzes revenue onFDA’s requests for Additional Information. These 510(k) applications have since expired and are no longer under FDA review. Further, while Magellan’s LeadCare testing systems remain cleared for marketing by the FDA and permitted for use with capillary blood samples, the FDA advised that it has commissioned a constant-currency basisthird-party study of Magellan’s LeadCare testing systems using both venous and capillary blood samples. According to better measure the comparabilityFDA, the results of results between periods. Because changes in foreign currency exchange rates have anon-operating impact on revenue, management believes that evaluating revenue changes on a constant-currency basis provides an additional and meaningful assessment of revenue to both management and investors.

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

Pageother information, including review by an FDA Advisory Committee, to determine whether further action by the FDA or the CDC is necessary to protect the public health. Meridian intends to fully cooperate with the FDA as the third-party study and Advisory Committee review are completed.

During October 2019, the FDA performed a
follow-up
inspection of Magellan’s manufacturing facility. The FDA issued five Form FDA 483 observations. In November 2019, we submitted to the FDA our written responses to the five Form FDA 483 observations and have implemented a remediation plan that we are actively working. In January and February 2020, we submitted to the FDA additional written responses to the Form FDA 483 observations. On March 18,

2020, we participated in a regulatory meeting with the FDA at the FDA’s request to further discuss the Form FDA 483 observations and our remediation efforts. While we remain committed to strengthening Magellan’s quality system and ensuring that all aspects of the system are in full compliance, we can provide no assurance that our remediation efforts will be successful to a degree acceptable by the FDA.


   Three Months   Six Months 
   Ended March 31,   Ended March 31, 
   2019   2018   2019   2018 

Operating Expenses -

        

U.S. GAAP basis

  $19,503  $26,891  $40,524   $50,840 

Acquisition & restructuring costs

   (785   (3,458   (872   (4,192

Litigation costs

   (603   (1,453   (1,192   (2,202
  

 

 

   

 

 

   

 

 

   

 

 

 

Adjusted Operating Expenses

  $18,115  $21,980  $38,460   $44,446 
  

 

 

   

 

 

   

 

 

   

 

 

 

Operating Income -

        

U.S. GAAP basis

  $9,835  $7,678  $20,386   $15,739 

Acquisition & restructuring costs

   785   3,458   872    4,192 

Litigation costs

   603   1,453   1,192    2,202 
  

 

 

   

 

 

   

 

 

   

 

 

 

Adjusted Operating Income

  $11,223  $12,589  $22,450   $22,133 
  

 

 

   

 

 

   

 

 

   

 

 

 

Net Earnings -

        

U.S. GAAP basis

  $7,094  $5,288  $15,200   $11,590 

Acquisition & restructuring costs (1)

   602   2,517   669   3,052 

Litigation costs(1)

   463   1,058   914   1,603 

One-time benefit from tax law change

   —     —     —      (1,695

Repatriation transition tax

   —     —     —      854 
  

 

 

   

 

 

   

 

 

   

 

 

 

Adjusted Net Earnings

  $8,159  $8,863  $16,783   $15,404 
  

 

 

   

 

 

   

 

 

   

 

 

 

Net Earnings per Basic Common Share -

        

U.S. GAAP basis

  $0.17  $0.12  $0.36  $0.27

Acquisition & restructuring costs

   0.01   0.06   0.02   0.07

Litigation costs

   0.01   0.02   0.02   0.04

One-time benefit from tax law change

   —     —     —     (0.04

Repatriation transition tax

   —     —     —     0.02
  

 

 

   

 

 

   

 

 

   

 

 

 

Adjusted Basic EPS(2)

  $0.19  $0.21  $0.40  $0.36
  

 

 

   

 

 

   

 

 

   

 

 

 

Net Earnings per Diluted Common Share -

        

U.S. GAAP basis

  $0.17  $0.12  $0.35  $0.27

Acquisition & restructuring costs

   0.01   0.06   0.02   0.07

Litigation costs

   0.01   0.02   0.02   0.04

One-time benefit from tax law change

   —     —     —     (0.04

Repatriation transition tax

   —     —     —     0.02
  

 

 

   

 

 

   

 

 

   

 

 

 

Adjusted Diluted EPS(2)

  $0.19  $0.21  $0.39  $0.36
  

 

 

   

 

 

   

 

 

   

 

 

 

(1)

These acquisition and restructuring costs, and litigation costs are net of the following income tax effects: $183 and $140, respectively, for the three months ended March 31, 2019; $941 and $395, respectively, for the three months ended March 31, 2018; $203 and $278, respectively, for the fiscal 2019year-to-date period; and $1,140 and $599, respectively, for the fiscal 2018year-to-date period. These tax effects were calculated using the effective tax rates of the jurisdictions in which the costs were incurred.

(2)

Neither Net Earnings per Basic Common Share nor Net Earnings per Diluted Common Share for the fiscal 2018 quarterly period sum to their respective Adjusted EPS amounts due to rounding.

Page 19

In the course of remediation, we may encounter additional matters that warrant notifications to the FDA and/or customers regarding the use of our products. At this time, we do not believe that any such notifications would impact the ability to use the LeadCare systems with capillary blood samples. While we remain confident in the performance of the Magellan LeadCare testing systems using capillary samples, we do not expect that the FDA will reinstate our venous blood claims. We can provide no assurance that the ongoing investigation and study of the DOJ and FDA, respectively, or future exercise of their respective enforcement, regulatory, discretionary or other powers will not result in findings or alleged violations of federal laws that could lead to enforcement actions, proceedings or litigation and the imposition of damages, fines, penalties, restitution, other monetary liabilities, sanctions, injunctions, settlements or changes to our business practices, product offerings or operations that could have a material adverse effect on our business, financial condition or results of operations; or eliminate altogether our ability to operate our lead testing business, or on terms substantially similar to those on which we currently operate.


REVENUE OVERVIEW

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

By Reportable Segment & Geographic Region

-By Reportable Segment & Geographic Region

By Product Platform/Type

-By Product Platform/Type
Revenue Overview- By Reportable Segment & Geographic Region

Our reportable segments are Diagnostics and Life Science, withScience. The Diagnostics segment consists of manufacturing operations for infectious disease diagnostic products in Cincinnati, Ohio and Quebec City, Canada, and manufacturing operations for blood chemistry products in Billerica, Massachusetts (near Boston). These diagnostic test products are 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 descriptionThe Life Science segment consists of our segments is set forthmanufacturing operations in Note 9,“Reportable SegmentsMemphis, Tennessee; Boca Raton, Florida; London, England; and Major Customers Information”Luckenwalde, Germany, and the sale and distribution of the accompanying Condensed Consolidated Financial Statements.

bulk antigens, antibodies, PCR/qPCR reagents, nucleotides, and bioresearch reagents domestically and abroad, including a sales and business development facility, with outsourced distribution capabilities, in Beijing, China to further pursue growing revenue opportunities in 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 the severity of seasonal diseases and outbreaks, and foreign currency exchange rates. Revenues for the Life Science segment, in the normal course of business, may be affected
Page 23

Table of Contents
from quarter to quarter by buying patterns of major IVD manufacturing customers and foreign currency exchange rates.

   Three Months Ended March 31,  Six Months Ended March 31, 
   2019  2018  Inc (Dec)  2019  2018  Inc (Dec) 

Diagnostics -

       

Americas

  $27,278 $33,351  (18)%  $58,425 $64,926  (10)% 

EMEA

   5,535  5,912  (6)%   10,620  11,327  (6)% 

ROW

   687  519  32  1,120  1,019  10
  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

 

Total Diagnostics

   33,500  39,782  (16)%   70,165  77,272  (9)% 
  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

 

Life Science -

       

Americas

   5,453  5,121  6  9,975  10,373  (4)% 

EMEA

   7,901  7,478  6  15,376  12,659  21

ROW

   3,394  4,070  (17)%   6,212  8,430  (26)% 
  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

 

Total Life Science

   16,748  16,669  —    31,563  31,462  —  
  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

 

Consolidated

  $50,248 $56,451  (11)%  $101,728 $108,734  (6)% 
  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

 

% of total revenues -

       

Diagnostics

   67  70   69  71 

Life Science

   33  30   31  29 
  

 

 

  

 

 

   

 

 

  

 

 

  

Total

   100  100   100  100 
  

 

 

  

 

 

   

 

 

  

 

 

  

Ex-Americas

   35  32   33  31 
  

 

 

  

 

 

   

 

 

  

 

 

  

Revenue Overview- By Product Platform/Type

The revenues generated by each

See the “Revenue Disaggregation” section of our reportable segments result primarily from the sale Note 2,
“Significant Accounting Policies”
of the following segment-specific categories of products:

Diagnostics

1)

Molecular assays that operate on our Alethia platform (formerly branded asillumigene)

2)

Immunoassays and blood chemistry assays on multiple technology platforms

Life Science

1)

Molecular reagents

2)

Immunological reagents

Page 20


Revenuesaccompanying Condensed Consolidated Financial Statements 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, 
   2019  2018  Inc (Dec)  2019  2018  Inc (Dec) 

Diagnostics-

       

Molecular assays

  $7,132 $9,976  (29)%  $14,434 $18,692  (23)% 

Immunoassays & blood chemistry assays

   26,368  29,806  (12)%   55,731  58,580  (5)% 
  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

 

Total Diagnostics

  $33,500 $39,782  (16)%  $70,165 $77,272  (9)% 
  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

 

Life Science-

       

Molecular reagents

  $5,390 $6,143  (12)%  $11,998 $11,832  1

Immunological reagents

   11,358  10,526  8  19,565  19,630  —  
  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

 

Total Life Science

  $16,748 $16,669  —   $31,563 $31,462  —  
  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

 

% of Diagnostics revenues-

       

Molecular assays

   21  25   21  24 

Immunoassays & blood chemistry assays

   79  75   79  76 
  

 

 

  

 

 

   

 

 

  

 

 

  

Total Diagnostics

   100  100   100  100 
  

 

 

  

 

 

   

 

 

  

 

 

  

% of Life Science revenues-

       

Molecular reagents

   32  37   38  38 

Immunological reagents

   68  63   62  62 
  

 

 

  

 

 

   

 

 

  

 

 

  

Total Life Science

   100  100   100  100 
  

 

 

  

 

 

   

 

 

  

 

 

  

detailed revenue disaggregation information.

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

Diagnostics Products

The acquisition of the Revogene molecular diagnostics platform, the development of the Curian
®
immunoassay platform, and the expansion of the related assay-menu for each of these platforms are important steps in addressing competitive pressures in our gastrointestinal and respiratory illness assay families. We are actively converting our existing Alethia
®
install base to the Revogene platform for
C. difficile
, Group A
Streptococcus
(“Group A Strep”) and Group B
Streptococcus
(“Group B Strep”) assays. As previously noted, the
COVID-19
pandemic dramatically slowed the placement of our molecular assay products during the quarter, resulting in 35 Revogene systems being installed during the second quarter of fiscal 2020 and a total Revogene system install base of 148 systems as of March 31, 2020. In March 2020, we received clearance from the FDA for the Curian immunoassay diagnostics instrument and its first assay, a test for
H. pylori
antigen in stool. We believe the advantages of the Curian analyzer will help protect our existing rapid test accounts.
Gastrointestinal Assays

During the second quarter and first six months of fiscal 2019,2020, revenues from our gastrointestinal products, which include tests for
C. difficile
,
H. pylori
and certain foodborne pathogens, among others, totaled $16,177$14,014 and $34,792,$30,060, respectively. These revenue levels represent 16%13% and 12%14% decreases for this product category from the fiscal 20182019 quarterly and
year-to-date
periods, respectively. OurC. difficile productsThese decreases result in large part from the pricing and volume pressures we continue to experience pressure as a result of competition, particularly our Alethiaface within this product which experienced volume declines impacting both the quarterly andyear-to-date periods. For our stool antigenH. pylori products, wecategory. We have executed multi-year supply agreements with a number of customers, including our two largest reference laboratory customers for
H. pylori
tests to secure volume, albeit at lower selling prices. As a consequence of this strategy, such products experienced price declines for the quarterly andyear-to-date periods. We continue to believe there are ongoing benefits to be realized from our partnerships with managed care companies in promoting:from: (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. We experienced a favorable volume increaseBeginning in April, we began seeing lower order demand for the quarterly periodmost of our gastrointestinal products as a result of promotingthe
COVID-19
pandemic.
Contributing to the competitive pressures being faced in this test and treat strategy.

Page 21


Theproduct category, the patents for our

H. pylori
products, owned by us, 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 continue to increase, in the near future, and 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. Our product development pipeline includes new product initiativesWe intend for our Curian HpSA
®
assay, cleared by the detection ofH. pylori, and earlyFDA in the first quarter of fiscal 2019 we entered intoMarch 2020, to help protect our existing customer base using lateral flow tests. We also maintain a strategic collaboration with DiaSorin to sell
H. pylori tests (see Note 10,“Litigation Matters” of the accompanying Condensed Consolidated Financial Statements).
tests. We are unable to provide assurances that we will be successful with any strategy or that any strategy will prevent an adverse effect on our future results of operations and liquidity, including revenues and gross profit.

Respiratory Illness Assays

Including

Overcoming lower sales volumes in the first quarter of fiscal 2020, revenues for our respiratory illness products, which include tests for Group A Strep, Mycoplasma pneumonia, influenza,Influenza, and Pertussis, among others, our respiratory illness product revenues decreased 21%increased 44% and 9%20% in the second quarter and first six months of fiscal 2019,2020, respectively. The quarterly decreaseThese increases primarily resultsreflect volume increases in Group A Strep, Influenza and Mycoplasma related products from a significant decrease invery strong respiratory season, including the volume of tests sold, reflecting the fact that the prior year 2017-2018 flu season was a particularly strong one, as measured by outpatientinfluenza-like illness surveillance data published by the CDC.

COVID-19
pandemic.
Blood Chemistry Assays

Revenues from our sale of products to test for elevated levels of lead in blood increased 2%remained flat during the second quarter of fiscal 2019 to2020 at a totallevel of $4,330,$4,329 and increased 3%8% for the fiscal
year-to-date
period to $8,760. In late December 2018,$9,479. During the documents to reinstatelatter part of March, we began seeing lower order demand for our venous blood claims removed in fiscal 2017 were submitted to the FDA, and in March 2019, we were informed by the FDA that eachblood-lead test as a result of the submitted 510(k) applications has been put on Additional Information (AI) hold. Further, while our LeadCare testing systems remain cleared for marketing by the FDA for use with capillary blood samples, the FDA advised that it has commissioned a third-party study
COVID-19
pandemic.
Page 24

Table of the LeadCare testing systems using both venous and capillary blood samples. According to the FDA, the results of the field study will be used in conjunction with other information to determine whether further action by FDA and CDC is necessary to protect the public health. We intend to fully cooperate with the FDA as it completes its third-party study and continue to work to complete remediation actions at our blood–chemistry manufacturing facility to the FDA’s full and complete satisfaction. We remain confident in the performance of the LeadCare products and believe that they serve a critical role in promoting the public health.

See Note 10,“Litigation Matters” of the accompanying Condensed Consolidated Financial Statements for additional information related to the Company’s LeadCare product line. See also Part II, Item 1A Risk Factors below.

Contents

Life Science Products

During the second quarter of fiscal 2019,2020, revenues from our Life Science segment remained flatincreased 33% compared to the fiscal 20182019 second quarter, with revenues from molecular reagent sales decreasing 12%increasing 114% and revenues from immunological reagent sales increasing 8%decreasing 5%. Life Science segment revenues also remained flatincreased 11% for the first six months of fiscal 2019,2020, reflecting a slight41% increase in revenues from molecular reagent sales being offset by a slightand an 8% decrease in immunological reagent sales. Our Life Science segment’s revenue growth was slightly impacted by the movement in currency exchange rates since the fiscal 20182019 periods, with revenues increasing 2% on a constant-currency basis34% and 12% over both the second quarter and first six months of fiscal 2018. Our Life Science segment was also impacted by buying patterns of certain IVD manufacturing customers in China, with such sales totaling approximately $1,350 and $2,350 during the second quarter and first six months of fiscal 2019, respectively, – representing decreaseson a constant-currency basis. The increase in revenues was primarily attributable to the increased demand for key molecular components such as RNA master mixes and dNTPs from diagnostic test manufacturers for use in
COVID-19
related tests. Largely as a result of this
COVID-19
related demand, revenue from sales into China totaled approximately 37% and 33%, respectively, from$5,300 for the second quarter of fiscal 2020, a fourfold increase over the comparable fiscal 2018 periods.

Page 22

2019 quarter. For the first six months of fiscal 2020, revenue from sales into China totaled approximately $7,100, or a threefold increase over the comparable fiscal 2019 period.


Additionally, order patterns for

non-COVID-19
related products from many of our top IVD manufacturing customers returned to more normal levels during the current quarter. However, it remains unclear whether the shortfall experienced from these customers during the fiscal 2020 first quarter will be overcome throughout the remainder of the fiscal year.
Significant Customers

Revenue concentrations related to certain customers within our Diagnostics and Life Science segments are set forth in Note 9,10,
“Reportable Segments and Major Customers Information”
of the accompanying Condensed Consolidated Financial Statements.

Gross Profit

   Three Months Ended March 31,  Six Months Ended March 31, 
   2019  2018  Change  2019  2018  Change 

Gross Profit

  $29,338 $34,569  (15)%  $60,910 $66,579  (9)% 

Gross Profit Margin

   58  61  -3 points   60  61  -1 point 

                         
 
Three Months Ended March 31,
  
Six Months Ended March 31,
 
 
2020
  
2019
  
Change
  
2020
  
2019
  
Change
 
Gross Profit
 $
  34,454
  $
  29,338
   
17
% $
  61,894
  $
  60,910
   
2
%
Gross Profit Margin
  
60
%  
58
%  
2 points
   
59
%  
60
%  
-1 point
 
The gross profit margin decreasesincrease experienced in the second quarter of fiscal 2019 result2020 results primarily from the impactpositive impacts of a significantly higher percentage of the Life Science segment’s revenue relating to sales of molecular products and the segment’s manufacturing of larger-than-normal batch sizes for the RNA master mixes, both in response to the
COVID-19
pandemic demand. The decrease during the six month fiscal
year-to-date
period primarily reflects the effect of this increased
COVID-19
demand being more than offset by the combined effects of: (i) previously-noted pricing changes within our
H. pylori
product line, along with the combined effects ofline; (ii) mix of products sold, particularly decreased contribution from certain of our higher margin gastrointestinal assays; and operating segment mix.

(iii) production capacity

ramp-up
costs for our Quebec facility where Revogene instruments and test devices are made.
Page 25

Operating Expenses - Segment Detail

   Three Months Ended March 31, 2019 
   Research &
Development
   Selling &
Marketing
   General &
Administrative
   Other  Total Operating
Expenses
 

Fiscal 2018:

 

Diagnostics

  $3,735  $6,101  $4,795  $—    $14,631

Life Science

   756   2,546   2,235   —    5,537

Corporate

   —     —     1,812   4,911  6,723
  

 

 

   

 

 

   

 

 

   

 

 

  

 

 

 

Total Expenses (2018 Quarter)

  $4,491  $8,647  $8,842  $4,911 $26,891
  

 

 

   

 

 

   

 

 

   

 

 

  

 

 

 

Fiscal 2019:

 

Diagnostics

  $3,172  $5,481  $4,336  $(125) $12,864

Life Science

   644   1,430   1,439   25  3,538

Corporate

   —     —     1,613   1,488  3,101
  

 

 

   

 

 

   

 

 

   

 

 

  

 

 

 

Total Expenses (2019 Quarter)

  $3,816  $6,911  $7,388  $1,388 $19,503
  

 

 

   

 

 

   

 

 

   

 

 

  

 

 

 
   Six Months Ended March 31, 2019 
   Research &
Development
   Selling &
Marketing
   General &
Administrative
   Other  Total Operating
Expenses
 

Fiscal 2018:

 

Diagnostics

  $7,425  $12,526  $9,899  $—    $29,850

Life Science

   1,470   4,935   4,251   —    10,656

Corporate

   —     —     3,940   6,394  10,334
  

 

 

   

 

 

   

 

 

   

 

 

  

 

 

 

Total Expenses (2018Year-to-Date)

  $8,895  $17,461  $18,090  $6,394 $50,840
  

 

 

   

 

 

   

 

 

   

 

 

  

 

 

 

Fiscal 2019:

 

Diagnostics

  $6,286  $11,523  $9,027  $(125) $26,711

Life Science

   1,414   2,951   2,930   25  7,320

Corporate

   —     —     4,329   2,164  6,493
  

 

 

   

 

 

   

 

 

   

 

 

  

 

 

 

Total Expenses (2019Year-to-Date)

  $7,700  $14,474  $16,286  $2,064 $40,524
  

 

 

   

 

 

   

 

 

   

 

 

  

 

 

 

Page 23


                                                                                                                                                      
 
Three Months Ended March 31,
 
 
Research &
Development
  
Selling &
Marketing
  
General &
Administrative
  
Other
  
Total Operating
Expenses
 
Fiscal 2019:
               
Diagnostics
 $
  3,172
  $
  5,481
  $
4,336
  $
760
  $
  13,749
 
Life Science
  
644
   
1,430
   
1,439
   
25
   
3,538
 
Corporate
  
—  
   
—  
   
1,613
   
603
   
2,216
 
                     
Total Expenses (2019 Quarter)
 $
  3,816
  $
  6,911
  $
7,388
  $
  1,388
  $
  19,503
 
                     
Fiscal 2020:
               
Diagnostics
 $
  4,791
  $
  5,374
  $
6,363
  $
(505
) $
  16,023
 
Life Science
  
595
   
1,140
   
1,906
   
103
   
3,744
 
Corporate
  
—  
   
—  
   
2,211
   
685
   
2,896
 
                     
Total Expenses (2020 Quarter)
 $
  5,386
  $
  6,514
  $
  10,480
  $
283
  $
  22,663
 
                     

                                                                                                                                                      
 
Six Months Ended March 31,
 
 
Research &
Development
  
Selling &
Marketing
  
General &
Administrative
  
Other
  
Total Operating
Expenses
 
Fiscal 2019:
               
Diagnostics
 $
6,286
  $
  11,523
  $
9,027
  $
847
  $
  27,683
 
Life Science
  
1,414
   
2,951
   
2,930
   
25
   
7,320
 
Corporate
  
—  
   
—  
   
4,329
   
1,192
   
5,521
 
                     
Total Expenses (2019
Year-to-Date)
 $
7,700
  $
  14,474
  $
  16,286
  $
  2,064
  $
  40,524
 
                     
Fiscal 2020:
               
Diagnostics
 $
9,017
  $
  10,713
  $
  11,841
  $
812
  $
  32,383
 
Life Science
  
1,193
   
2,485
   
3,467
   
198
   
7,343
 
Corporate
  
—  
   
—  
   
3,928
   
1,055
   
4,983
 
                     
Total Expenses (2020
Year-to-Date)
 $
  10,210
  $
  13,198
  $
  19,236
  $
2,065
  $
  44,709
 
                     
Operating Expenses – Comparisons to Prior Year Periods

   Three Months Ended March 31, 2019 
   Research &
Development
  Selling &
Marketing
  General &
Administrative
  Other  Total Operating
Expenses
 

2018 Expenses

  $4,491  $8,647  $8,842  $4,911  $26,891 
  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

 

% of Revenues

   8  15  16  9  48

Fiscal 2019 Increases/(Decreases):

      

Diagnostics

   (563  (620  (459  (125  (1,767

Life Science

   (112  (1,116  (796  25   (1,999

Corporate

   —     —     (199  (3,423  (3,622
  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

 

2019 Expenses

  $3,816  $6,911  $7,388  $1,388  $19,503 
  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

 

% of Revenues

   8  14  15  3  39

% Decrease

   (15)%   (20)%   (16)%   (72)%   (27)% 
   Six Months Ended March 31, 2019 
   Research &
Development
  Selling &
Marketing
  General &
Administrative
  Other  Total Operating
Expenses
 

2018 Expenses

  $8,895  $17,461  $18,090  $6,394  $50,840 
  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

 

% of Revenues

   8  16  17  6  47

Fiscal 2019 Increases/(Decreases):

      

Diagnostics

   (1,139  (1,003  (872  (125  (3,139

Life Science

   (56  (1,984  (1,321  25   (3,336

Corporate

   —     —     389   (4,230  (3,841
  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

 

2019 Expenses

  $7,700  $14,474  $16,286  $2,064  $40,524 
  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

 

% of Revenues

   8  14  16  2  40

% Decrease

   (13)%   (17)%   (10)%   (68)%   (20)% 

Total

                                                                                                                                       
 
Three Months Ended March 31, 2020
 
 
Research &
Development
  
Selling &
Marketing
  
General &
Administrative
  
Other
  
Total Operating
Expenses
 
2019 Expenses
 $
  3,816
  $
  6,911
  $
7,388
  $
1,388
  $
  19,503
 
                     
% of Revenues
  
8
%  
14
%  
15
%  
3
%  
39
%
Fiscal 2020 Increases/(Decreases):
               
Diagnostics
  
1,619
   
(107
)  
2,027
   
(1,265
)  
2,274
 
Life Science
  
(49
)  
(290
)  
467
   
78
   
206
 
Corporate
  
—  
   
—  
   
598
   
82
   
680
 
                     
2020 Expenses
 $
5,386
  $
6,514
  $
10,480
  $
283
  $
22,663
 
                     
% of Revenues
  
9
%  
11
%  
18
%  
1
%  
40
%
% Increase (Decrease)
  
41
%  
(6
)%  
42
%  
(80
)%  
16
%
Page 26

Table of Contents
                                                                                                                                       
 
Six Months Ended March 31, 2020
 
 
Research &
Development
  
Selling &
Marketing
  
General &
Administrative
  
Other
  
Total Operating
Expenses
 
2019 Expenses
 $
7,700
  $
  14,474
  $
  16,286
  $
  2,064
  $
  40,524
 
                     
% of Revenues
  
8
%  
14
%  
16
%  
2
%  
40
%
Fiscal 2020 Increases/(Decreases):
 
Diagnostics
  
2,731
   
(810
)  
2,814
   
(35
)  
4,700
 
Life Science
  
(221
)  
(466
)  
537
   
173
   
23
 
Corporate
  
—  
   
—  
   
(401
)  
(137
)  
(538
)
                     
2020 Expenses
 $
  10,210
  $
  13,198
  $
  19,236
  $
  2,065
  $
  44,709
 
                     
% of Revenues
  
10
%  
13
%  
18
%  
2
%  
43
%
% Increase (Decrease)
  
33
%  
(9
)%  
18
%  
-
%  
10
%
The changes in operating expenses primarily reflect the following:
Increased Research & Development costs, primarily for the development of the Revogene system GI and RI panel assays for the Diagnostics operating segment;
Decreased Selling & Marketing costs, primarily reflecting the effects of reorganization and streamlining initiatives;
Increased General & Administrative costs, primarily reflecting additional investment in incentive compensation, along with the purchase accounting amortization from the acquisition of the GenePOC business; and
Increased acquisition and restructuring costs, along with a decrease in fair value of the contingent consideration obligation for the GenePOC business, all of which are reflected within “Other” in the above tables.
Operating Income
Operating income increased 20% to $11,791 for the second quarter of fiscal 2020 and decreased during both16% to $17,185 for the first six months of fiscal 2020, as a result of the factors discussed above.
Income Taxes
The effective rate for income taxes was 26% and 27% for the second quarter and first six months of fiscal 20192020, respectively, compared to the respective fiscal 2018 periods, with overall decreases in spending in all of our segments, reflecting the following:

1)

Decreased Research & Development costs due primarily to the timing of product development projects and the clinical trials for our cCMV test in fiscal 2018;

2)

Decreased Selling & Marketing costs due to: (i) the effects of the fiscal 2018 organization streamlining initiatives; and (ii) lower sales commissions resulting from the decrease in sales levels;

3)

Decreased General & Administrative costs due to: (i) the effects of the fiscal 2018 organization streamlining initiatives; and (ii) lower Quality System remediation costs related to our blood-lead manufacturing facility; and

4)

Decreased restructuring & litigation costs (reflected within “Other” in the above tables).

Operating Income

Operating income increased 28% to $9,835 for the second quarter of fiscal 2019, and increased 30% to $20,386 for the first six months of fiscal 2019, as a result of the factors discussed above, including the costs associated with acquisition and restructuring activities, and litigation costs.

Page 24


Income Taxes

The effective rate for income taxes was 23% for both thecorresponding periods in fiscal 2019 second quarter and six monthyear-to-date period, compared to 27% and 22% during the corresponding2019. This higher fiscal 2018 periods. These fluctuations in2020 tax rates resultrate results largely from the fact that

non-deductibility
of the fiscal 2019 periods reflectacquisition-related costs related to Exalenz, along with the tax impact of restricted share units lapsing on a date when the share price was significantly lower U.S. federalthan the share price on the date the restricted share units were granted. In accordance with current applicable guidance, the tax effect of this difference is recorded directly to income tax expense. We expect our effective tax rate of 21% being fullyphased-in, whilefor the full fiscal 2018 periods reflect the combined net impact of the following effects of the tax reform act (see Note 7,“Income Taxes” of the accompanying Condensed Consolidated Financial Statements):

1)

Application of an approximate 24.5% blended rate due to the lowering of the applicable rate from 35% to 21% on aphased-in basis;

2)

Recognizing in the first quarter aone-time $1,695 tax benefit, including there-measurement of deferred tax balances at the lower rate; and

3)

Recording in the first quarter a provisionalone-time $854 tax expense related to the estimated repatriation transition tax on foreign earnings.

year to approximate 25.5% to 26.5%.

Liquidity and Capital Resources

Comparative Cash Flow Analysis

Liquidity
Our cash flow and financing requirements are determined by analyses of operating and capital spending budgets and debt service,service. We have historically maintained a credit facility to augment working capital requirements and consideration ofto respond quickly to acquisition plans, including our pending acquisition of GenePOC (see Note 12, “Subsequent Event” of the accompanying Condensed Consolidated Financial Statements).

opportunities.

We have an investment policy that guides the holdings of our investment portfolio, which presently consists of bank savings accounts and institutional money market mutual funds. Our objectives in managing the investment portfolio
Page 27

Table of Contents
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.

Considering the various worldwidegeo-political andgeo-economic conditions, 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 from current cash flows from operating activities and cash on hand. If needed, we also have an additional source of liquidity through the amount remaining available on our $30,000$160,000 bank revolving credit facility.facility, which totaled approximately $61,200 as of April 30, 2020, following the additional $50,000 drawn on the credit facility in April to complete the acquisition of Exalenz. 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 collectability of our customer accounts receivable, impact credit terms with our vendors, or disrupt the supply of raw materials and services.

As of March 31, 2019,2020, our cash and equivalents balance is $66,097was $49,550 or $9,697 higher$17,547 lower than at the end of the fiscal 20182019 second quarter, and $6,334 higher$12,847 lower than at September 30, 2018. This increase resultsthe end of fiscal 2019, resulting in large part from the $27,000 revolving credit facility payment in January 2020. As a result of the cash flows from operating activities being more than sufficientgenerated during the first six months of fiscal 2020, since the beginning of fiscal 2020, our balance of net debt (defined as bank debt and total contingent obligations related to cover capital expendituresthe acquisition of the GenePOC, net of cash and debt service.equivalents
on-hand)
has decreased approximately $15,500 to approximately $30,200 at March 31, 2020. Net cash flows from operating activities and cash on hand are anticipated to be adequate to fund working capital requirements, and capital expenditures and debt service during the next 12twelve months.

Capital Resources

In 2016,

The impacts of COVID-19 have adversely affected the capital markets and the ability of many companies to access capital and liquidity on favorable terms or at all. The Company expects to be in compliance with its financial covenants for at least the next twelve months. However, the Company enteredis currently unable to predict the impact that COVID-19 will have on its ability to access capital in the future. If the Company is unable to access additional capital and liquidity on acceptable terms, it could adversely impact the Company’s results of operations and ability to meet its future obligations beyond the next twelve months.
In April 2019, we suspended the payment of our quarterly cash dividend. The dividend was suspended as part of our regular evaluation of capital allocation, with the action taken in order to deploy cash into a $60,000 five-year term loannew product development activities for the Revogene molecular diagnostic platform, as well as the Curian and related interest rate swap agreement with a commercial bank, the details of which are set forthPediastat
®
platforms, among other investments, and to preserve capital resources and liquidity for general corporate purposes.
Capital Resources
As described in Note 8,9,
“Bank Credit Arrangements”
of the accompanying Condensed Consolidated Financial Statements. In addition, we haveStatements and above, the Company maintains a $30,000 revolving$160,000 credit facility, (discussed above) with a commercial bank that expires March 31, 2021. Aswhich is secured by substantially all of April 30, 2019, there were no borrowings outstanding on this facilityour assets 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 2019 or during the full year of fiscal 2018.

Page 25

includes certain restrictive financial covenants.


Our capital expenditures are estimated to range between approximately $4,000$3,000 to $5,000$4,000 for fiscal 2019,2020, 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$160,000 revolving credit facility discussed above.

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

On April 29, 2019, we signed a definitive agreement to acquire substantially all

Page 28

Table of the assets, as well as selected liabilities, of GenePOC Inc., a molecular diagnostics company located in Quebec City, Quebec Province, Canada. This purchase will be included in our Diagnostics operating segment. The maximum purchase price is $120,000, which consists of: (i) $50,000 to be paid at closing (subject to a working capital adjustment and a $5,000 hold-back to secure seller’s post-closing obligations); (ii) up to $20,000 to be paid in fiscal 2021, contingent upon the achievement of product development milestones; and (iii) up to $50,000 to be paid in fiscal 2023 based on certain sales and profit margin thresholds to be measured in fiscal 2022. GenePOC’s molecular diagnostics testing system is branded under the name revogene, and currently includes threeFDA-cleared assays (C. difficile, Group A Strep and Group B Strep). The purchase is expected to close no later than early fourth quarter fiscal 2019, pending the satisfaction of certain closing conditions.

In connection with the proposed acquisition of GenePOC, we also expect to execute a new five-year $125,000 revolving credit facility that would replace our existing $30,000 credit facility. We expect the new credit facility will be secured by substantially all of our assets and will include certain restrictive financial covenants. We expect to draw down approximately $73,000 from this new facility and use approximately $20,000 of cashon-hand to repay the existing term loan outstanding at March 31, 2019 and fund the closing payment for the acquisition of GenePOC.

Also, our Board of Directors suspended the declaration and payment of quarterly dividends by Meridian to invest in new product development activities for the revogene molecular diagnostics platform, among other investments in the business, and to preserve our capital resources and liquidity for general corporate purposes.

Contents

ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

There

Other than the impact of the recent outbreak of
COVID-19
on our business and results of operations as discussed elsewhere in this report, there have been no material changes in the Company’s exposure to market risk since September 30, 2018.

2019.

ITEM 4. CONTROLS AND PROCEDURES

Evaluation of Disclosure Controls and Procedures

Under the supervision and with the participation of the Company’s management, including the Chief Executive Officer and Chief Financial Officer, we have evaluated the effectiveness of the Company’s disclosure controls and procedures, as defined in Rules
13a-15(e)
and
15d-15(e)
under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), as of March 31, 2019.2020. Based on this evaluation, our Chief Executive Officer and Chief Financial Officer have concluded that the Company’s disclosure controls and procedures were effective as of March 31, 2019.

2020.

Changes in Internal Control over Financial Reporting

There were no changes in our internal control over financial reporting (as that term is defined in Rules
13a-15(f)
and
15d-15(f)
under the Exchange Act) during the quarter ended March 31, 20192020 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

Page 26


PART II. OTHER INFORMATION

ITEM 1. LEGAL PROCEEDINGS

See Note 10,11,
“Litigation Matters”
of the accompanying Condensed Consolidated Financial Statements.

ITEM 1A. RISK FACTORS

The

There have been no material changes from risk factors as previously disclosed in the Company’s fiscal 2019 Annual Report on Form
10-K
in response to Item 1A to Part I of Form
10-K,
except that we are adding the following risk factor is addeddiscussion relating to the risk factors included in Item 1Acoronavirus
COVID-19.
Our financial condition, results of Part I of the Company’s Annual Report on Form10-K:

The United States Department of Justiceoperations and FDA are investigating our Magellan lead testing systems, and any adverse finding, allegation, or exercise of enforcement or regulatory discretioncash flows could be adversely affected by the DOJ ongoing coronavirus

(COVID-19)
outbreak.
Any outbreak of contagious diseases, such as
COVID-19,
or FDAother adverse public health developments, could materiallyhave material and adverse effects on our business operations. Such adverse effects could include diversion or prioritization of health care resources away from the conduct of diagnostic testing, disruptions of or restrictions on the ability of laboratories to process our tests, and delays with respect to or difficulties in patients accessing our tests, including those resulting from an inability to travel as a result of quarantines or other restrictions resulting from
COVID-19.
As
COVID-19
continues to affect individuals and businesses around the globe, we may experience disruptions that could severely impact our business, including:
decreased volume of testing and related sales of certain of our Diagnostics products as a result of disruptions to health care providers and limitations on the ability of providers to administer tests;
disruptions or restrictions on the ability of our, our collaborators’, or our suppliers’ personnel to travel, and temporary closures of our facilities or the facilities of our collaborators or suppliers;
limitations on employee resources that would otherwise be focused on the development of our products, processing our diagnostic tests, and the conduct of our clinical trials, including because
Page 29

of sickness of employees or their families or requirements imposed on employees to avoid contact with large groups of people; and
delays in necessary interactions with local regulators, ethics committees and other important agencies and contractors due to limitations in employee resources or forced furlough of government employees.
In addition, the continued spread of
COVID-19
globally could adversely affect our business, financial condition, ormanufacturing and supply chains. Parts of our direct and indirect supply chains are located overseas, including in China, and may accordingly be subject to disruption. Additionally, our results of operations.

As previously disclosed, on June 29, 2017, the FDA, in connection with its Safety Notification related to Magellan’s LeadCaretesting systems for venous blood samples, issued to Magellan its Form 483, Inspectional Observations. The FDA issued a related Warning Letter on October 23, 2017. As also previously disclosed, on April 17, 2018, Magellan received a subpoena from the United States Department of Justice (“DOJ”) regarding its LeadCare product line. The subpoena outlines documents tooperations could be produced, and we continue to cooperate with the DOJ in this matter, including responding to additional information requests and executing a tolling agreement to extend the statute of limitations.

Magellan submitted 510(k) applications in December 2018, seeking to reinstate venous blood sample-types for its LeadCare® II, LeadCare® Plus and LeadCare Ultra® testing systems. In the second fiscal quarter of 2019 the FDA informed Magellan that each of these 510(k) applications has been put on Additional Information hold. Further, while Magellan’s LeadCare testing systems remain cleared for marketing by the FDA and permitted for use with capillary blood samples, the FDA advised that it has commissioned a third-party study of Magellan’s LeadCare testing systems using both venous and capillary blood samples. Accordingadversely affected to the FDA,extent that

COVID-19
or any other epidemic harms our business or the resultseconomy in general either domestically or in any other region in which we do business. The extent to which
COVID-19
affects our operations will depend on future developments, which are highly uncertain and cannot be predicted with confidence, including the duration of the field study will be used in conjunction with otheroutbreak, new information to determine whether further action by FDA orthat may emerge concerning the Centers for Disease Control and Prevention is necessary to protect the public health. Meridian intends to fully cooperate with the FDA as FDA completes its third-party study and continues to work to complete remediation actions at Magellan’s blood–chemistry manufacturing facility to the FDA’s full and complete satisfaction.

While we remain confident in the performanceseverity of the Magellan LeadCare testing systems, there can be no assurance that the ongoing investigation and study of the DOJ and FDA, respectively, or future exercise of their respective enforcement, regulatory, discretionary or other powers will not result in findings or alleged violations of federal laws that could lead to enforcement actions, proceedings or litigation

COVID-19,
and the imposition of damages, fines, penalties, restitution, other monetary liabilities, sanctions, settlements actions to contain
COVID-19
or changes to our business practices, product offerings or operations thattreat its impact, among others, which could have a materialan adverse effect on our business, financial condition or results of operations;operations and financial condition.
To date, we are seeing that the outbreak has slowed our assay instrument placements and sales of related test kits as diagnostic testing sites have turned their attention to critical care testing. We are unable to predict when expected sales volume levels for our instruments and related test kits will return. Also, as a result of the pandemic, certain clinical trials related to our products which were underway or eliminate altogetherscheduled to begin have been temporarily placed on hold. Such delays will impact our abilitytiming for filing applications for product clearances with the FDA, as well as related timing of FDA clearances of such filings. Additionally, the pandemic could slow down our efforts to operateexpand our lead testing business, or on terms substantially similar to those onproduct portfolio through acquisitions and distribution opportunities, impacting the speed with which we currently operate.

are able to bring additional products to market.
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ITEM 6. EXHIBITS

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

 2.1** 
2.1
10.1
10.2
31.1 
31.1
31.2 
31.2

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32 
32
101 The following financial information from Meridian Bioscience Inc.’s Quarterly Report on Form10-Q for the quarter ended March 31, 2019 filed with the SEC on May 7, 2019, formatted
101.INS
Inline XBRL Instance Document
101.SCH
Inline XBRL Instance Extension Schema
101.CAL
Inline XBRL Instance Extension Calculation Linkbase
101.DEF
Inline XBRL Instance Extension Definition Linkbase
101.LAB
Inline XBRL Instance Extension Label Linkbase
101.PRE
Inline XBRL Instance Extension Presentation Linkbase
104
Cover Page Interactive Data File (formatted as Inline XBRL and contained in XBRL includes: (i) Condensed Consolidated Statements of Operations for the three and six months ended March 31, 2019 and 2018; (ii) Condensed Consolidated Statements of Comprehensive Income for the three and six months ended March 31, 2019 and 2018; (iii) Condensed Consolidated Statements of Cash Flows for the six months ended March 31, 2019 and 2018; (iv) Condensed Consolidated Balance Sheets as of March 31, 2019 and September 30, 2018; (v) Condensed Consolidated Statements of Shareholders’ Equity for the three and six months ended March 31, 2019 and 2018; and (vi) the Notes to Condensed Consolidated Financial StatementsExhibit 101)

**

Schedules to and certain portions of Exhibit 2.1 have been omitted pursuant to Item 601(b)(2) of RegulationS-K. The omitted information is not material and would likely cause competitive harm to the Registrant if publicly disclosed. The Registrant hereby agrees to furnish a copy of any omitted schedule or other portion to the SEC upon request.

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Table of Contents
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 7, 20198, 2020
  
By:
 

/s/ Bryan T. Baldasare

   
Bryan T. Baldasare
   

Senior

Executive Vice President Corporate Controller, Treasurer and Chief AccountingFinancial Officer

(Principal Financial and Accounting Officer)

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