Table of Contents
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form
10-Q
QUARTERLY REPORT PURSUANT TO SECTION 13 or 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the Quarterly Period Ended December 31, 20192020
OR
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from
_______ to
_______
Commission file number    0-14902
MERIDIAN BIOSCIENCE, INC.
Incorporated under the laws of Ohio
31-0888197
(I.R.S. Employer Identification No.)
3471 River Hills Drive
Cincinnati, Ohio 45244
(513)
271-3700
Securities registered pursuant to Section 12(b) of the Act:
Title of each class
  
Trading
Symbol(s)
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  

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Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a
non-accelerated
filer, smaller reporting company, or an emerging growth company. See definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule
12b-2
of the Exchange Act.
Large accelerated filer
 
  
Accelerated filer
 
☒ 
    
Non-accelerated
filer
 
  
Smaller reporting company
 
    
Emerging growth company   
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  
Indicate by check mark whether the registrant is a shell company (as defined in Rule
12b-2
of the Exchange Act).    Yes  
    No  
Indicate the number of shares outstanding of each of the issuer’s classes of common stock, as of the latest practicable date.
Class
 
Outstanding January 31, 20202021
Common Stock, no par value
 
42,829,480
43,145,015

MERIDIAN BIOSCIENCE, INC. AND SUBSIDIARIES
TABLE OF CONTENTS TO QUARTERLY REPORT ON FORM
10-Q
    
  
Page(s)
 
   
PART I.
  
     
Item 1.
  
     
 
1
2
3
   
14-5
 
   
 6
   
     
27-19
 
   
  
3
4-
5
6
7-
18
Item 2.
   
19-19-28
24
 
   
Item 3.
     
24
28
 
   
Item 4.
28
PART II.
     
Item 4.1.
     
24
28
 
   
Item 1A.
  28
   
PART II.Item 6.
     28 
   
Item 1.
24
      
Item 1A.
24
Item 6.
26
26
29
 
FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form
10-Q
contains forward-looking statements. The Private Securities Litigation Reform Act of 1995 provides a safe harbor from civil litigation for forward-looking statements accompanied by meaningful cautionary statements. Except for historical information, this report contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, which may be identified by words such as “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 Bioscience, Inc. (“Meridian” or “the Company”) expects or anticipates will occur in the future, including, but not limited to, statements relating to per share diluted earnings, sales, product demand, revenue, operating margin, other guidance and revenue,the impact of
COVID-19
on its 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 ourthe Company’s 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

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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 future 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 theThe Company can make no assurances that a material weakness in its internal control over financial reporting will not be identified in the future, which if identified and not properly corrected, could materially adversely affect ourits operations and result in material misstatements in ourits 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
COVID-19.
In addition to the factors described in this paragraph, as well as those factors identified from time to time in ourthe Company’s filings with the Securities and Exchange Commission, Part I, Item 1A Risk Factors of ourthe Company’s 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 ourthe Company’s forward-looking statements.

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PART I. FINANCIAL INFORMATION
Item 1. Financial Statements
MERIDIAN BIOSCIENCE, INC. AND SUBSIDIARIES
Condensed Consolidated Statements of Operations (Unaudited)
(dollar and share amounts in thousands, except per share data)
 
Three Months Ended
 
 
December 31,
 
 
2019
  
2018
 
NET REVENUES
 $
 
47,421
  $
 
51,480
 
COST OF SALES
  
19,981
   
19,908
 
GROSS PROFIT
  
27,440
   
31,572
 
OPERATING EXPENSES
      
Research and development
  
4,824
   
3,967
 
Selling and marketing
  
6,684
   
7,563
 
General and administrative
  
8,756
   
8,902
 
Change in fair value of contingent consideration obligation
  
1,187
   
 
 
 
Restructuring costs
  
275
   
—  
 
Selected legal costs
  
320
   
589
 
Total operating expenses
  
22,046
   
21,021
 
OPERATING INCOME
  
5,394
   
10,551
 
 
 
 
 
 
 
 
 
 
OTHER INCOME (EXPENSE)
      
Interest income
  
111
   
149
 
Interest expense
  
(767
)  
(363
)
Other, net
  
(712
  
139
 
Total other expense
  
(1,368
)  
(75
)
EARNINGS BEFORE INCOME TAXES
  
4,026
   
10,476
 
         
INCOME TAX PROVISION
  
1,199
   
2,370
 
NET EARNINGS
 $
2,827
  $
8,106
 
BASIC EARNINGS PER COMMON SHARE
 $
0.07
  $
0.19
 
DILUTED EARNINGS PER COMMON SHARE
 $
0.07
  $
0.19
 
WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING - BASIC
  
42,789
   
42,446
 
EFFECT OF DILUTIVE STOCK OPTIONS AND RESTRICTED SHARE UNITS
  
149
   
459
 
WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING - DILUTED
  
42,938
   
42,905
 
ANTI-DILUTIVE SECURITIES:
      
Common share options and restricted share units
  
1,407
   
684
 
DIVIDENDS DECLARED PER COMMON SHARE
 $
—  
  $
0.125
 
 
   
Three Months Ended
 
   
December 31,
 
   
 
2020
  
 
2019
 
NET REVENUES
  $92,917  $47,421 
COST OF SALES
   31,369   19,770 
          
GROSS PROFIT
   61,548   27,651 
          
OPERATING EXPENSES
         
Research and development
   5,651   4,763 
Selling and marketing
   7,021   6,728 
General and administrative
   11,938   8,984 
Change in fair value of acquisition consideration    1,047   1,187 
Restructuring costs
   —     275 
Selected legal costs
   1,227   320 
          
Total operating expenses
   26,884   22,257 
          
OPERATING INCOME
   34,664   5,394 
   
OTHER INCOME (EXPENSE)
         
Interest income
   9   111 
Interest expense
   (534  (767
RADx grant income  
800
   
 
 
 
Other, net
   (691  (712
          
Total other expense, net   (416  (1,368
          
EARNINGS BEFORE INCOME TAXES
   34,248   4,026 
   
INCOME TAX PROVISION
   7,469   1,199 
          
NET EARNINGS
  $26,779  $2,827 
          
BASIC EARNINGS PER COMMON SHARE
  $0.62  $0.07 
DILUTED EARNINGS PER COMMON SHARE
  $0.61  $0.07 
WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING—BASIC   43,098   42,789 
EFFECT OF DILUTIVE STOCK OPTIONS AND RESTRICTED SHARE UNITS   681    149 
WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING—DILUTED   43,779   42,938 
          
ANTI-DILUTIVE SECURITIES:
         
Common share options and restricted share units
   258   1,407 
          
The accompanying notes are an integral part of these condensed consolidated financial statements.
 
Page 1

MERIDIAN BIOSCIENCE, INC. AND SUBSIDIARIES
Condensed Consolidated Statements of Comprehensive Income (Unaudited)
(dollar amounts in thousands)
 
Three Months Ended
 
 
December 31,
 
 
2019
  
2018
 
NET EARNINGS
 $
 
2,827
  $
 
8,106
 
Other comprehensive income (loss):
      
Foreign currency translation adjustment
  
2,768
   
(716
)
Unrealized loss on cash flow hedge
  
   
(577
)
Reclassification of gain on cash flow hedge
  
(77
)  
—  
 
Income taxes related to items of other comprehensive income
  
19
   
145
 
         
Other comprehensive income (loss), net of tax
  
2,710
   
(1,148
)
         
COMPREHENSIVE INCOME
 $
 5,537
  $
 6,958
 
         
   
Three Months Ended
December 31,
 
   
2020
  
2019
 
NET EARNINGS
  $ 26,779  $ 2,827 
Other comprehensive income (loss):
         
Foreign currency translation adjustment
   3,301   2,768 
Unrealized gain on cash flow hedge   21   —   
Reclassification of amortization of gain on cash flow hedge
   (77  (77
Income taxes related to items of other comprehensive income
   14   19 
          
Other comprehensive income, net of tax
   3,259   2,710 
          
COMPREHENSIVE INCOME
  $ 30,038  $ 5,537 
          
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)
         
Three Months Ended December 31,
 
2019
  
2018
 
CASH FLOWS FROM OPERATING ACTIVITIES
      
Net earnings
 $
2,827
  $
8,106
 
Non-cash
items included in net earnings:
      
Depreciation of property, plant and equipment
  
1,218
   
1,253
 
Amortization of intangible assets
  
1,722
   
829
 
Stock-based compensation
  
788
   
1,670
 
Deferred income taxes
  
419
   
96
 
Change in accrued contingent consideration
  
1,187
   
 
 
 
Change in the following:
      
Accounts receivable
  
550
   
317
 
Inventories
  
(3,526
)  
(37
)
Prepaid expenses and other current assets
  
1,434
   
539
 
Accounts payable and accrued expenses
  
(664
)  
(4,081
)
Income taxes payable
  
(464
  
991
 
Other, net
  
(203
)  
(197
)
Net cash provided by operating activities
  
5,288
   
9,486
 
CASH FLOWS FROM INVESTING ACTIVITIES
      
Purchase of property, plant and equipment
  
(340
)  
(1,109
)
Net cash used for investing activities
  
(340
)  
(1,109
)
CASH FLOWS FROM FINANCING ACTIVITIES
      
Dividends paid
  
   
(5,301
)
Payments on term loan
  
   
(1,125
)
Proceeds from exercise of stock options
  
 
 
   
66
 
Net cash used for financing activities
  
 
 
   
(6,360
)
Effect of Exchange Rate Changes on Cash and Equivalents and Restricted Cash
  
1,212
   
(257
)
Net Increase in Cash and Equivalents and Restricted Cash
  
6,160
   
1,760
 
Cash and Equivalents and Restricted Cash at Beginning of Period
  
62,397
   
60,763
 
Cash and Equivalents and Restricted Cash at End of Period
 $
68,557
  $
62,523
 
         
Cash and Equivalents
 $
68,557
  $
61,523
 
Restricted Cash
  
—  
   
1,000
 
Cash and Equivalents and Restricted Cash at End of Period
 $
 68,557
  $
 62,523
 
         
 
Three Months Ended December 31,
  
2020
  
2019
 
CASH FLOWS FROM OPERATING ACTIVITIES
         
Net earnings
  $ 26,779  $2,827 
Non-cash
items included in net earnings:
         
Depreciation of property, plant and equipment
   1,508   1,218 
Amortization of intangible assets
   2,221   1,722 
Stock-based compensation
   1,241   788 
Deferred income taxes
   (852  419 
Change in acquisition consideration   1,047   1,187 
Change in the following:
         
Accounts receivable
   (1,776  550 
Inventories
   (5,941  (3,526
Prepaid expenses and other current assets
   2,682   1,434 
Accounts payable and accrued expenses
   (5,826  (664
Income taxes payable
   4,032   (464
Other, net
   6   (203
          
Net cash provided by operating activities
   25,121   5,288 
          
CASH FLOWS FROM INVESTING ACTIVITIES
         
Purchase of property, plant and equipment
   (2,086  (340
Payment of acquisition consideration holdback
   (5,000  —   
          
Net cash used for investing activities
   (7,086  (340
          
CASH FLOWS FROM FINANCING ACTIVITIES
         
Payment on revolving credit facility   (10,000  —   
          
Net cash used for financing activities
   (10,000  —   
          
Effect of Exchange Rate Changes on Cash and Cash Equivalents   1,644   1,212 
          
Net Increase in Cash and Cash Equivalents   9,679   6,160 
Cash and Cash Equivalents at Beginning of Period   53,514   62,397 
          
Cash and Cash Equivalents at End of Period  $ 63,193  $ 68,557 
          
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
         
 
December 31,
2019
(Unaudited)
  
September 30,
2019
 
CURRENT ASSETS
      
Cash and equivalents
 $
68,557
  $
62,397
 
Accounts receivable, less allowances of $527 and $537
,
respectively
  
35,318
   
35,608
 
Inventories
  
42,827
   
39,617
 
Prepaid expenses and other current assets
  
5,730
   
7,139
 
         
Total current assets
  
152,432
   
144,761
 
         
PROPERTY, PLANT AND EQUIPMENT, at Cost
      
Land
  
985
   
982
 
Buildings and improvements
  
31,928
   
31,904
 
Machinery, equipment and furniture
  
65,320
   
64,155
 
Construction in progress
  
943
   
522
 
         
Subtotal
  
99,176
   
97,563
 
Less: accumulated depreciation and amortization
  
68,681
   
66,996
 
         
Net property, plant and equipment
  
30,495
   
30,567
 
         
OTHER ASSETS
      
Goodwill
  
89,958
   
89,241
 
Other intangible assets, net
  
58,586
   
60,243
 
Right-of-use assets
  6,041   
 
 
 
Deferred income taxes
  
132
   
156
 
Other assets
  
484
   
510
 
Total other assets
  
155,201
   
150,150
 
TOTAL ASSETS
 $
 
 
338,128
  $
325,478
 
         
 
The accompanying notes are an integral part of these condensed consolidated financial statements.
Page 4
3

MERIDIAN BIOSCIENCE, INC. AND SUBSIDIARIES
Condensed Consolidated Balance Sheets
(dollar amounts in thousands)
ASSETS
LIABILITIES AND SHAREHOLDERS’ EQUITY
December 31,
2020
(Unaudited)
September 30,
2020
         
 
December 31,
2019
(Unaudited)
  
September 30,
2019
 
CURRENT LIABILITIES
      
Accounts payable
 $
7,932
  $
7,238
 
Accrued employee compensation costs
  
6,401
   
7,938
 
Accrued interest expense
  
958
   
498
 
Current portion of acquisition consideration
  
13,653
   
—  
 
Current operating lease obligations
  
1,333
   
—  
 
Other accrued expenses
  
2,977
   
3,260
 
Income taxes payable
  
1,599
   
1,980
 
Total current liabilities
  
34,853
   
20,914
 
NON-CURRENT
LIABILITIES
      
Acquisition consideration
  
19,736
   32,202 
Post-employment benefits
  
2,484
   
2,500
 
Long-term operating lease obligations
  4,480   
 
 
 
Long-term debt
  
75,824
   
75,824
 
Long-term income taxes payable
  
549
   
549
 
Deferred income taxes
  
2,910
   
2,522
 
Total
non-current
liabilities
  
105,983
   
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, 42,827,758 and 42,712,296 shares issued, respectively
  
—  
   
—  
 
Additional
paid-in
capital
  
133,622
   
132,834
 
Retained earnings
  
65,935
   
63,108
 
Accumulated other comprehensive loss
  
(2,265
)  
(4,975
)
Total shareholders’ equity
  
197,292
   
190,967
 
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY
 $
338,128
  $
325,478
 
CURRENT ASSETS
          
Cash and cash equivalents  $63,193   $53,514 
Accounts receivable, less allowances of $579 and $513, respectively
   40,936    38,512 
Inventories, net   67,243    61,264 
Prepaid expenses and other current assets
   6,244    8,900 
           
Total current assets
   177,616    162,190 
           
PROPERTY, PLANT AND EQUIPMENT, at Cost
          
Land
   997    991 
Buildings and improvements
   32,320    32,188 
Machinery, equipment and furniture
   71,647    69,854 
Construction in progress
   6,118    1,200 
           
Subtotal
   111,082    104,233 
Less: accumulated depreciation and amortization
   75,094    73,113 
           
Property, plant and equipment, net   35,988    31,120 
           
OTHER ASSETS
          
Goodwill
   114,868    114,186 
Other intangible assets, net
   80,976    83,197 
Right-of-use assets, net
   6,213    6,336 
Deferred income taxes
   7,714    7,647 
Other assets
   555    585 
           
Total other assets
   210,326    211,951 
           
TOTAL ASSETS
  $ 423,930   $ 405,261 
           
The accompanying notes are an integral part of these condensed consolidated financial statements.
Page 5
4

MERIDIAN BIOSCIENCE, INC. AND SUBSIDIARIES
Condensed Consolidated Balance Sheets
(dollar amounts in thousands)
LIABILITIES AND SHAREHOLDERS’ EQUITY
   
December 31,
2020

(Unaudited)
   
September 30,
2020
 
CURRENT LIABILITIES
          
Accounts payable
  $15,348   $11,969 
Accrued employee compensation costs
   10,581    16,661 
Current portion of acquisition consideration
   11,303    12,619 
Current operating lease obligations
   1,835    1,789 
Current government grant obligations
   727    600 
Other accrued expenses
   6,052    5,362 
Income taxes payable
   7,985    3,524 
           
Total current liabilities
   53,831    52,524 
           
NON-CURRENT
LIABILITIES
          
Acquisition consideration
   10,653    13,290 
Post-employment benefits
   2,494    2,493 
Fair value of interest rate swaps
   693    713 
Long-term operating lease obligations
   4,513    4,678 
Long-term debt
   58,824    68,824 
Government grant obligations
   10,495    10,524 
Long-term income taxes payable
   384    549 
Deferred income taxes
   3,007    3,804 
Other
non-current
liabilities
   169    233 
           
Total
non-current
liabilities
   91,232    105,108 
           
COMMITMENTS AND CONTINGENCIES
   0    0 
   
SHAREHOLDERS’ EQUITY
          
Preferred stock, 0 par value; 1,000,000 shares authorized; NaN issued
   0—      0—   
Common shares, 0 par value; 71,000,000 shares authorized,
 
43,124,190
and
43,068,842
shares issued, respectively
   0—      0—   
Additional
paid-in
capital
   141,395    140,195 
Retained earnings
   136,073    109,294 
Accumulated other comprehensive income (loss)   1,399    (1,860
           
Total shareholders’ equity
   278,867    247,629 
           
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY
  $ 423,930   $ 405,261 
           
The accompanying notes are an integral part of these condensed consolidated financial statements.
Page 5

MERIDIAN BIOSCIENCE, INC. AND SUBSIDIARIES
Condensed Consolidated Statements of Changes in Shareholders’ Equity (Unaudited)
(dollar and share amounts in thousands, except per share data)thousands)
                     
 
Common
Shares
Issued
  
Additional
Paid-In

Capital
  
Retained
Earnings
  
Accumulated Other
Comprehensive
Income (Loss)
  
Total
Shareholders’
Equity
 
Balance at September 30, 2019
  
42,712
  $
132,834
  $
63,108
  $
(4,975
) $
190,967
 
Conversion of restricted share units and
 
exercise of stock options
  
116
   
   
—  
   
—  
   
 
Stock compensation expense
  
—  
   
788
   
—  
   
—  
   
788
 
Net earnings
  
—  
   
—  
   
2,827
   
—  
   
2,827
 
Foreign currency translation adjustment
  
—  
   
—  
   
—  
   
2,768
   
2,768
 
Hedging activity, net of tax
  
—  
   
—  
   
—  
   
(58
)  
(58
)
Balance at December 31, 2019
  
42,828
  $
133,622
  $
65,935
  $
(2,265
) $
197,292
 
Balance at September 30, 2018
  
42,400
  $
129,193
  $
49,602
  $
(3,377
) $
175,418
 
Cash dividends paid - $0.125 per share
  
—  
   
—  
   
(5,301
)  
—  
   
(5,301
)
Conversion of restricted share units and
 
exercise of stock options
  
89
   
13
   
—  
   
—  
   
13
 
Stock compensation expense
  
—  
   
1,670
   
—  
   
—  
   
1,670
 
Net earnings
  
—  
   
—  
   
8,106
   
—  
   
8,106
 
Foreign currency translation adjustment
  
—  
   
—  
   
—  
   
(716
)  
(716
)
Hedging activity, net of tax
  
—  
   
—  
   
—  
   
(432
)  
(432
)
Adoption of ASU
2014-09
  
—  
   
—  
   
(116
)  
—  
   
(116
)
Balance at December 31, 2018
  
42,489
  $
130,876
  $
52,291
  $
(4,525
) $
178,642
 
 
   Common
Shares
Issued
   Additional
Paid-In

Capital
  Retained
Earnings
   Accumulated Other
Comprehensive
Income (Loss)
   Total
Shareholders’
Equity
 
Balance at September 30, 2020
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 43,069   $ 140,195 $ 109,294   $ (1,860)   $ 247,629 
Conversion of restricted share units and exercise of stock options   55    (41)  
 
 
    
 
 
    (41
)
 
Stock compensation expense
   —      1,241   —      —      1,241 
Net earnings
   —      —     26,779    —      26,779 
Foreign currency translation adjustment
   —      —     —      3,301    3,301 
Hedging activity, net of tax
   —      —     —      (42)    (42)
                         
Balance at December 31, 2020
   43,124   $ 141,395  $ 136,073   $ 1,399   $ 278,867 
                         
Balance at September 30, 2019
   42,712   $ 132,834  $63,108   $ (4,975)   $ 190,967 
Conversion of restricted share units and exercise of stock options
   116    —     —      —      —   
Stock compensation expense
   —      788   —      —      788 
Net earnings
   —      —     2,827    —      2,827 
Foreign currency translation adjustment
   —      —     —      2,768    2,768 
Hedging activity, net of tax
   —      —        —      (58)    (58)
                         
Balance at December 31, 2019
   42,828   $ 133,622  $65,935   $ (2,265)   $ 197,292 
                         
The accompanying notes are an integral part
of these
condensed consolidated financial statements.
Page 6

MERIDIAN BIOSCIENCE, INC. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements
Dollars in Thousands, Except Per Share Amounts
(Unaudited)
1.
Nature of Business
Meridian Bioscience, Inc. (“Meridian” or “the Company”) 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 testing systems and 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, and bioresearch reagents used by other diagnostic manufacturers and researchers.
Our reportable segments are Diagnostics and Life Science. The Diagnostics segment consists of: (i) manufacturing operations for infectious disease products in Cincinnati, Ohio; Quebec City, Canada; and Modi’in, Israel; (ii) manufacturing operations for blood chemistry products in Billerica, Massachusetts (near Boston); and (iii) 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.
The Life Science segment consists of: (i) manufacturing operations in Memphis, Tennessee; Boca Raton, Florida; London, England; and Luckenwalde, Germany; and (ii) the sale and distribution of 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 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).
2.
Basis of Presentation
The interim condensed consolidated financial statementsCondensed Consolidated Financial Statements are unaudited and are prepared in accordance with United States (“U.S.”) generally accepted accounting principles generally accepted in the United States of America(“GAAP”) for interim financial information, and the rules and regulations of the Securities and Exchange Commission.Commission (“SEC”). Certain information and footnote disclosures normally included in financial statements prepared in accordance with generally accepted accounting principlesGAAP have been condensed or omitted pursuant to such rules and regulations. In the opinion of Management, the interim financial statements
Condensed
Consolidated Financial Statements include all normal adjustments and disclosures necessary to present fairly the Company’s financial position as of December 31, 2019,2020 and the results of its operations, cash flows and shareholders’ equity for the three
-
monththree-month periods ended December 31, 20192020 and 2018, and its cash flows for the three
-
month periods ended December 31, 2019 and 2018.2019. These statementsCondensed Consolidated Financial Statements should be read in conjunction with the audited consolidated financial statements and footnotes thereto included in the Company’s fiscal 20192020 Annual Report on Form
10-K.10-K
filed with the SEC on November 23, 2020.
It should be noted that the terms revenue and/or revenues are utilized throughout these notes to the Condensed Consolidated Financial information as of September 30, 2019 has been derived from the Company’s audited consolidated financial statements. Statements to indicate net revenue and/or net revenues.
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. In January 2021, the U.S. Department of Health and Human Services extended the public health emergency declaration for
COVID-19
into April 2021. Governments around the world have implemented lockdown and
shelter-in-place
orders, requiring many
non-essential
businesses to shut down operations, many of which remain in effect as of the date of this filing. Our business, however, was deemed “essential” and we have continued to operate, manufacture and distribute products to customers globally.
Page 7

While revenues within our Life Science segment have been positively impacted by the
COVID-19
pandemic, to date, the negative impacts of
COVID-19
on the Company have been limited to decreased demand for most of our Diagnostics segment’s products and the pausing and/or slowing of clinical trials for new product development programs, as diagnostics testing has focused primarily on
COVID-19
and critical care ailments. Although we do not expect to sustain the level of Life Science segment revenues experienced during the fiscal quarter ended December 31, 2020, over the next twelve months, we do expect current general directional trends in our revenues to continue, particularly during our second fiscal quarter ending March 31, 2021. Specifically, we expect our Life Science segment to continue to experience elevated levels of demand for
COVID-19
reagents. In addition, by the end of fiscal 2021, we expect our Diagnostics segment’s level of revenues to improve as health care facilities return to
pre-pandemic
non-critical
care testing and treatments
,
and we begin to offer COVID-19 tests. However, due to the many uncertainties surrounding the
COVID-19
pandemic, we can provide no assurances with respect to our views of the longevity, severity or impacts to our financial condition of the
COVID-19
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.
The preparation of the Condensed Consolidated Financial Statements in conformity with GAAP requires the Company to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the Condensed Consolidated Financial Statements and the reported amounts of revenues and expenses during the period. Actual results could differ from those estimates.
2.
3.
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 201
9
2020 Annual Report on Form
10-K
filed with the SEC on November 23, 2020 and should be referred to for a description of the Company’s current significant accounting policies, with the exception of Revenue Recognition, which is set forth below.policies.
(a) Revenue RecognitionRecent Accounting Pronouncements
Revenue DisaggregationPronouncements Adopted
The following tables presentOn October 1, 2020, the Company adopted Financial Accounting Standards Board (“FASB”) Accounting Standards Update (“ASU”)
2016-13,
Measurement of Credit Losses
on Financial Instruments
, which changed the impairment model used to measure credit losses for most financial assets. Use of the new forward-looking expected credit loss model for our revenues disaggregated by major geographic region, major product platform and disease state (Diagnostics only):accounts receivable valuation, rather than the previously utilized incurred credit loss model, resulted in an immaterial impact on the Condensed Consolidated Financial Statements.
Pronouncements Issued but Not Yet Adopted as of December 31, 2020
Revenue
In March 2020, the FASB issued ASU
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 GAAP to contracts, hedging relationships and other transactions affected by Reportable Segment & Geographic Regionreference rate reform if certain criteria are met, which may be applied through December 31, 2022.
The Company continues to evaluate the impacts of this guidance but does not expect its application to have a material impact on the Condensed Consolidated Financial Statements.
 
Three Months Ended December 31,
 
 
2019
  
2018
  
Inc (Dec)
 
Diagnostics-
         
Americas
 $
 
 
27,735
  $
 
 
30,423
   
(9
)%
EMEA
  
6,500
   
5,802
   
12
%
ROW
  
556
   
440
   
26
%
             
Total Diagnostics
  
34,791
   
36,665
   
(5
)%
             
Life Science-
         
Americas
  
4,019
   
4,521
   
(11
)%
EMEA
  
4,966
   
7,363
   
(33
)%
ROW
  
3,645
   
2,931
   
24
%
             
Total Life Science
  
12,630
   
14,815
   
(15
)
%
             
Consolidated
 $
47,421
  $
51,480
   
(8
)%
             
In December 2019, the FASB issued ASU
2019-12,
Page 7Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes
(“ASU
2019-12”).
ASU
2019-12
clarifies and simplifies accounting for income taxes by eliminating certain exceptions for intraperiod tax allocation principles, the methodology for calculating income tax rates in an interim period, and recognition of deferred taxes for outside basis differences in an investment, among other updates. ASU
2019-12
will be effective for the Company’s fiscal year beginning on October 1, 2021. The Company is currently evaluating the impact of ASU
2019-12
but does not
expect its application to have a material impact on the Condensed Consolidated Financial Statements.
Page 8

Table of Contents
Revenue by Product Platform/Type
 
Three Months Ended December 31,
 
 
2019
  
2018
  
Inc (Dec)
 
Diagnostics-
         
Molecular assays
 $
6,887
  $
7,231
   
(5
)%
Immunoassays & blood chemistry assays
  
27,904
   
29,434
   
(5
)%
             
Total Diagnostics
 $
 
 
34,791
  $
 
36,665
   
(5
)%
             
Life Science-
         
Molecular reagents
 $
5,357
  $
6,615
   
(19
)%
Immunological reagents
  
7,273
   
8,200
   
(11
)%
             
Total Life Science
 $
12,630
  $
14,815
   
(15
)
%
             
(b)
Reclassifications –
Revenue by Disease State (Diagnostics only)Certain reclassifications have been made to the prior year Condensed Consolidated Financial Statements to conform to the current year presentation. Such reclassifications had no impact on net earnings or shareholders’ equity.
 
Three Months Ended December 31,
 
 
2019
  
2018
  
Inc (Dec)
 
Diagnostics-
         
Gastrointestinal assays
 $
 
 
16,046
  $
 
18,615
   
(14
)%
Respiratory illness assays
  
7,749
   
7,981
   
(3
)%
Blood chemistry assays
  
5,150
   
4,430
   
16
%
Other
  
5,846
   
5,639
   
4
%
             
Total Diagnostics
 $
34,791
  $
36,665
   
(5
)%
             
4.
Revenue Recognition
Revenue PoliciesOverview
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 control 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 payable 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
Revenue Disaggregation
The following tables present our revenues disaggregated by major geographic region, major product platform 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.disease state (Diagnostics segment only):
Our payment terms differ
Revenue 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 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-offReportable Segment & Geographic Region
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.
 
   
Three Months Ended December 31,
 
   
2020
   
2019
   
Inc (Dec)
 
Diagnostics-
               
Americas
  $ 23,551   $ 27,735    (15)% 
EMEA
   6,020    6,500    (7)% 
ROW
   750    556    35
                
Total Diagnostics
   30,321    34,791    (13)% 
                
Life Science-
               
Americas
   18,755    4,012    367
EMEA
   32,311    4,960    551
ROW
   11,530    3,658    215
                
Total Life Science
   62,596    12,630    396
                
Consolidated
  $ 92,917   $ 47,421    96
                
Page 8
Revenue by Product Platform/Type
   
Three Months Ended
 
December 31,
 
   
2020
   
2019
   
Inc
 
(Dec)
 
Diagnostics-
               
Molecular assays
  $4,590   $6,903    (34)%
 
Non-molecular
assays
   25,731    27,888    (8)% 
                
Total Diagnostics
  $ 30,321   $ 34,791    (13)% 
                
Life Science-
               
Molecular reagents
  $ 46,029   $5,367    758
Immunological reagents
   16,567    7,263    128
                
Total Life Science
  $ 62,596   $ 12,630    396
                
Page 9

Practical Expedients and Exemptions
Revenue by Disease State (Diagnostics segment only)
Revenue is recognized net of any taxes collected from customers (sales tax, value added tax, etc.), which are subsequently remitted to government authorities.
   
Three Months Ended December 31,
 
   
2020
   
2019
   
Inc
 
(Dec)
 
Diagnostics-
               
Gastrointestinal assays
  $ 15,452   $ 16,251    (5)% 
Respiratory illness assays
   4,806    7,778    (38)% 
Blood chemistry assays
   4,394    4,951    (11)% 
Other
   5,669    5,811    (2)% 
                
Total Diagnostics
  $ 30,321   $ 34,791    (13)% 
                
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 be 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
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 us. Such arrangements are common practice in the diagnostics industry and are referred to as “Reagent Rentals”. 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 Accounting Standards Update (“ASU”) No.
 2014-09
but rather ASU
2016-02,
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 is recognized at a
point-in-time
when control transfers.
Revenue allocated to the lease elements of these Reagent Rental arrangements totaled approximately $1,150$880 and $1,050$1,150 in the three months ended December 31, 20192020 and 2018,2019, respectively, and areis included as part of net revenues in our Condensed Consolidated Statements of Operations.
(b)
Fair Value Measurements –
5.
Fair Value Measurements
AssetsCertain assets and liabilities are recorded at fair value in accordance with Accounting Standards Codification (“ASC”)
820-10,
820,
Fair Value Measurements and Disclosures
(“ASC 820”). ASC
820-10
820 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
820 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).
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
Page 9

Level 3
Prices or valuations that require inputs that are both significant to the fair value measurement and unobservable
In order to limit exposure to volatility in the LIBOR interest rate, the Company ha
s
 entered into interest rate swap agreements, which effectively convert the variable interest rate on $50,000
 
of the outstanding revolving credit facility
discussed in
Note 11 to a fixed rate. The value of the interest rate swap agreements was determined by reference to a third-party valuation and is considered a Level 2 input within the fair value hierarchy of valuation techniques.
As described in
Note
3
, 6, we acquired the business of GenePOCExalenz Bioscience Ltd. (“Exalenz”) in fiscal 2019.2020. The fair value of the acquired accounts receivable, inventories, property, plant and equipment, 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, intangiblewere valued using Level 2 inputs, which included data points that were observable, such as appraisals or established values of comparable assets and contingent consideration (market approach). Intangible assets
Page 
10

were valued using Level 3 inputs.inputs, which are unobservable by nature, and included internal estimates of future cash flows (income approach). Significant increases (decreases) in any of those unobservable inputs, as of the date of the acquisition, in isolation would result in a significantly lower (higher) fair value measurement. Management engaged a third-party valuation firm to assist in the determination of the preliminary purchase accounting fair values, and specifically those considered Level 3 measurements. Management ultimately oversees the third-party valuation firm to ensure that the transaction-specific assumptions are appropriate for the Company.
In connection with the acquisition of the business of GenePOC, Inc. (“GenePOC”) in fiscal 2019 and an updated agreement, dated September 29, 2020, to amend certain terms of the agreement related to contingent consideration achievement levels and milestone dates, the Company is required to make contingent consideration payments of up to
$64,000 (originally $70,000 at the acquisition date), comprised of up to $14,000 for achievement of product development milestones (originally $20,000 at the acquisition date) and up to $50,000
for achievement of certain financial targets. The fair value for the contingent consideration recognized upon the acquisition as part of the purchase price allocation was
$27,202.
The fair value of the product development milestone payments is estimated by discounting 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, and such calculations were updated for the effect of the previously noted amendment to the contingent consideration achievement levels and milestone dates. 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 revenues, probability of certain developments, expected expenses and discount rate. The ultimate settlement of contingent consideration could deviate from the current Level 3 measurement estimates based on the actual results of these financial measures.
The following table provides information by level for financial assets and liabilities that are measured at fair value on a recurring basis, noting that there were no such items as of September 30, 2018:
                 
 
 
 
 
 
Fair Value Measurements Using
Inputs Considered as
 
 
 
Carrying
Value
 
 
Level 1
 
 
Level 2
 
 
Level 3
 
Contingent consideration -                
As of December 31, 2019 $28,389  $—    $—    $28,389 
As of September 30, 2019 $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 development milestone payments was estimated by discounting the probability-weighted contingent payments to present value. Assumptions used in the calculations
inclu
de
 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 $28,389 as of December 31, 2019.
(c)
Recent Accounting Pronouncements –basis:
Pronouncements Adopted
On October 1, 2019, the Company adopted ASC 842,
Leases
. ASC 842 was issued to increase transparency and comparability among entities by recognizing
right-of-use
assets (“ROU assets”) and lease liabilities on the balance sheet and disclosing key information about lease arrangements. The 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 the 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. 
       
Fair Value Measurements Using
Inputs Considered as
 
   
Carrying

Value
   
Level 1
   
Level 2
   
Level 3
 
Interest rate swaps -
                    
As of December 31, 2020
  $(693)  $0     $(693)  $0   
As of September 30, 2020
  $(713)  $0     $ (713)  $0   
Contingent consideration (GeneP
OC
)
                    
As of December 31, 2020
  $ (21,956)  $0     $0     $(21,956
As of September 30, 2020
  $(20,909)  $0     $0     $ (20,909
 
Page 10

(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.
6.
Acquisition of
Business of GenePOCCombinations
On June 3, 2019,April 30, 2020 (“the acquisition date”), we acquired 100% of the businessoutstanding common shares and voting interest of GenePOC Inc. (“GenePOC”),Exalenz, a Quebec City, Quebec Province, CanadaModi’in, Israel based provider of molecular diagnostic instrumentsthe BreathID Breath Test Systems (“BreathID”), a breath test platform for the detection of
Helicobacter pylori.
Cash consideration totaled 168.6 million New Israeli Shekels (“NIS”), which equated to $48,237 at the date of closing. Including debt assumed and assays. The purchase agreement contemplates a maximumrepaid shortly after closing, the total consideration of up to $120,000, which
transferred was
estimated at a total fair value of $77,526
 as of $56,305. To finance the acquisition, date. Pursuant to the purchase agreement, the maximum consideration is comprised of the following (noting that the valuation values the contingent consideration identified in (ii) and (iii) below at an aggregate amount of
$27,202
 as of the acquisition date):
(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;
(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 December 31, 2019 as follows:
Current liabilities
- $13,653
Reflects anticipated settlement of the first product milestone payment and the holdback amounts in the first quarter of fiscal 2021.
Non-current liabilities
- $19,736
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.
WeCompany utilized cash and cash equivalents on hand and proceeds drawn from our $125,000 revolving credit facility (see Note 11). In anticipation of the transaction, we executed forward currency contracts to financeacquire the NIS required for the acquisition. Proceeds fromAs a result, the credit facility were also utilizednet cash outlay for the transaction prior to repay and settle the outstanding principal and interest due on our term loan (see Noterepayment of debt was $47,392.
9
).
As a result of estimated total consideration exceeding the preliminary fair value of the net assets acquired, goodwill in the amount of $34,582$24,503 was recorded in connection with this acquisition, none of which will be deductible for U.S. tax purposes ratably over 15 years.purposes. The goodwill results largely from
our
ability to market and sell GenePOC’s technology and instrumentthe BreathID platform through
our
established customer base and distribution channels.
Page 11

The Company’s consolidated results for the three months ended December 31, 2020 include $3,098 of net revenues and $792 of net loss from Exalenz. These results, which are reported as part of the Diagnostics segment, include $800
of amortization expense related to specific identifiable assets recorded in the preliminary purchase price allocation, including a
Purchase Price Allocationnon-compete
agreement, trade name, technology and customer relationships.
The recognized preliminary amounts of identifiable assets acquired and liabilities assumed in the acquisition of the GenePOC businessExalenz are as follows:
 
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
 
             
   
PRELIMINARY
 
   
April 30,
2020

(as initially
reported)
   
Measurement
Period
Adjustments
   
April 30,
2020

(as adjusted)
 
Fair value of assets acquired -
               
Cash
  $5,006   $—     $5,006 
Accounts receivable
   637    —      637 
Inventories
   4,329    —      4,329 
Other current assets
   851    1,825    2,676 
Property, plant and equipment
   544    39    583 
Goodwill
   29,288    (4,785   24,503 
Other intangible assets (estimated useful life):
               
Non-compete
agreement (5 years)
   120    (10   110 
Trade name (10 years)
   3,540    320    3,860 
Technology (15 years)
   5,590    530    6,120 
Customer relationships (10 years)
   19,370    1,270    20,640 
Right-of-use
assets
   1,358    (47   1,311 
Deferred tax assets, net
   5,566    1,151    6,717 
                
   76,199    293    76,492 
Fair value of liabilities assumed -
               
Accounts payable and accrued expenses (including current portion of lease and government grant obligations)
   7,757    251    8,008 
Long-term lease obligations
   1,054    42    1,096 
Long-term government grant obligations
   10,792    —      10,792 
Other
non-current
liabilities
   291    —      291 
                
    19,894    293    20,187 
                
Total consideration paid (including $8,068 to pay off long-term debt)
 $ 56,305   $—     $ 56,305 
                
As indicated, the allocation of the purchase price is preliminary, pending final completion of valuations. As a result of further refining its estimates and assumptions since the date of the acquisition, the Company recorded measurement period adjustments to the initial opening balance sheet as shown in the table above. Adjustments were primarily made to other current assets, goodwill, other intangible assets, and deferred tax assets, etc. There were no measurement period adjustments materially impacting net earnings that would have been recorded in previous reporting periods if the adjustments had been recognized as of the acquisition date. Currently, we are primarily assessing the results of the valuation of intangible assets and the tax implications thereon. Upon completion of these analyses, any required adjustments are expected to result in an amount being reclassified among goodwill, other intangible assets and deferred taxes, as
applicable
.
Page 12
Pro Forma Information
The following table provides the
unaudited
condensed
consolidated pro forma results for the periods presented as if the business of GenePOCExalenz had been
acquired
as of the beginning of fiscal 2019.2020. Pro forma results do not include the effect of any synergies anticipated to be achieved from the acquisition, and 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 December 31,
 
2019
  
2018
 
Net Revenues
 $
47,421
  $
51,552
 
Net Earnings
 $
2,827
  $
4,379
 
 
Page 12

Three Months Ended December 31,
  
2020
   
2019
 
Net Revenues
  $92,917   $51,194 
Net Earnings
  $26,779   $1,182 
These unaudited pro forma amounts have been calculated by
including
the results of GenePOC,Exalenz and adjusting the combined results to give effect to the following, as if the acquisition had been consummated on October 1, 2018,2019, together with the consequential tax effects thereon:
Three Months Ended December 31,
 
2019
  
2018
 
Adjustments to Net Revenues
      
GenePOC
pre-acquisition
revenues
 $
 —
  $
72
 
         
Adjustments to Net Earnings
      
GenePOC
pre-acquisition
net loss
 $
  $
(3,203
)
Pro forma adjustments:
      
Expenses related to
non-continuing
personnel,
 
locations or activities
  
   
568
 
Incremental depreciation and amortization
  
   
(876
)
Incremental interest costs
  
   
(284
)
Tax effects of pro forma adjustments
  
   
68
 
         
Total Adjustments to Net Earnings
 $
  $
(3,727
)
         
Three Months Ended December 31,
  
2020
   
2019
 
Adjustments to Net Revenues
          
Exalenz
pre-acquisition
revenues
  
$
0  
 
  $3,773 
           
Adjustments to Net Earnings
          
Exalenz
pre-acquisition
net losses
  
$
0  
 
  $(752
Pro forma adjustments:
          
Remove net impact of non-continuing personnel, locations or activities
  
 
0  
    101 
Incremental depreciation and amortization
  
 
0  
    (913
Incremental interest costs, net
  
 
0  
    (391
Tax effects of pro forma adjustments and recognizing benefit on resulting Exalenz losses
  
 
0  
    310 
           
Total Adjustments to Net Earnings
  $0     $(1,645
           
4.
7
.
RestructuringCash and
C
ash
Equivalents
Cash and
 cash
Duringequivalents include 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. Since that time and as part of this plan, certain functions and locations within both business units have 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 quarter 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.
following:
As a result of these activities, restructuring costs totaling $
275
 and $
2,839
were recorded during the three months ended December 31, 2019
and the fiscal year ended September 30, 2019, respectively.
   
December 31,
2020
   
September 30,
2020
 
 
Institutional money market funds
  $1,017   $1,017 
Cash on hand, unrestricted
   62,176    52,497 
           
Total
  $ 63,193   $ 53,514 
           
8
.
Inventories
, Ne
t
A reconciliationInventories, net are comprised of the changes in the liabilities associated with the restructuring charges from September 30, 2019 through December 31, 2019 is as follows:following:
 
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
  
236
   
80
   
   
316
 
Reversal of prior period accruals
  
(41
)  
   
   
(41
)
Payments
  
(1,020
)  
(65
)  
(114
)  
(1,199
)
                 
Balance at December 31, 2019
 $
185
  $
27
  $
  $
212
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   
December 31,
2020
   
September 30,
2020
 
 
Raw materials
  $ 13,868   $ 11,966 
Work-in-process
   20,874    19,477 
Finished goods - instruments
   1,532    1,594 
Finished goods - kits and reagents
   30,969    28,227 
           
Total
  $ 67,243   $ 61,264 
           
Page 131
3

5.
Cash and Equivalents9
.
Cash and equivalents include the following:
 
December 31,
2019
  
September 30,
2019
 
 
Institutional money market funds
 $
21,010
  $
20,913
 
Cash on hand, unrestricted
  
47,547
   
41,484
 
         
Total
 $
68,557
  $
62,397
 
         
6.
Inventories
Inventories are comprised of the following:
 
December 31,
2019
  
September 30,
2019
 
 
Raw materials
 $
8,549
  $
7,455
 
Work-in-process
  
12,209
   
11,504
 
Finished goods - instruments
  
688
   
935
 
Finished goods - kits and reagents
  
21,381
   
19,723
 
         
Total
 $
42,827
  $
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-us
e
right-of-use assets, net, current operating lease obligations and long-term
operating
lease obligations on the Condensed Consolidated Balance Sheet.Sheets. 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 Statement
s
of Operations for the three months ended December 31, 2019 reflect2020 reflects lease
costs
for these operating leases
of $129$158 and $267 $374
within cost of sales and operating expenses, respectively; and
$129 and $267
within cost of sales and operating expenses, respectively, for the three months ended December 31, 2019 . Right-of-use assets, net obtained during the three months ended December 31, 2020 and 2019, in exchange for operating lease liabilities totaled
$80 and $0, respectively.
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 sheetCondensed Consolidated Balance Sheets and the related lease expense is immaterial for the three months ended December 31, 2020 and 2019.
The Company often has options to renew lease terms, with the exercise 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
lease
s
leases as of December 31, 20192020 and September 30, 2020 was
3.9
4.7 years
. and 4.2 years, respectively.
The discount rate implicit within our leases is generally not determinable and, therefore, the Company determines the discount rate onusing its incremental borrowing rate. The weighted average discount rate used to measure our operating leases as of December 31, 20192020 and September 30, 2020 was
3.6
% and 3.7%
., respectively.
Page 14

Supplemental cash flow information related to the Company’s operating leases are as follows:
Three Months Ended December 31,
2019
Cash paid for amounts included in the measurement of lease liabilities:
Operating cash flows from operating leases
$
387
Maturities of lease liabilities by fiscal year for the Company’s operating lease liabilities were as follows as of December 31, 2019:2020:
 
December 31,
2019
 
Remainder of 2020
 $
  1,132
 
2021
  
1,456
 
2022
  
1,310
 
2023
  
967
 
2024
  
712
 
Thereafter
  
616
 
     
Total lease payments
  
6,193
 
Less amount of lease payment representing interest
  
(380
)
     
Total present value of lease payments
 $
  5,813
 
     
As of September 30, 2019, future minimum lease payments under noncancelable
   
December 31,
2020
 
 
2021 (represents remainder of fiscal year)
  $ 1,590 
2022
   1,873 
2023
   1,346 
2024
   1,002 
2025
   707 
Thereafter
   292 
      
Total lease payments
   6,810 
Less amount of lease payments representing interest   (462
      
Total present value of lease payments
  $ 6,348 
      
Supplemental cash flow information related to the Company’s operating leases wereare as follows:
 
September 30,
2019
 
2020
 $
  1,528
 
2021
  
1,451
 
2022
  
1,293
 
2023
  
967
 
2024
  
712
 
Thereafter
  
616
 
     
Total
 $
  6,567
 
 
Three Months Ended December 31,
  
2020
   
2019
 
 
Cash paid for amounts included in the measurement of lease liabilities:
          
Operating cash flows from operating leases
  $ 494   $ 387 
           
 
Page 15 
1
4

8.
10.
Goodwill and Other Intangible Assets, Net
During the three months ended December 31, 2020, goodwill increased $682, reflecting: (i) 
an additional
$37 acquisition measurement period adjustment upward related to Exalenz (Diagnostics segment; see Note 6); (ii) a $52 increase from the currency translation adjustment on
goodwill in the Diagnostics segment; and (iii) a
$593 increase from the currency translation adjustment
on
goodwill
in
the Life Science segment.
A summary of our acquiredother intangible assets, net subject to amortization is as follows:
   
December 31, 2020
   
September 30, 2020
 
   
Gross
Carrying
Value
   
Accumulated
Amortization
   
Gross
Carrying
Value
   
Accumulated
Amortization
 
Manufacturing technologies, core products and cell lines
  $62,436   $ 19,791   $62,363   $ 18,750 
Trade names, licenses and patents
   18,510    8,351    18,425    7,801 
Customer lists, customer relationships and supply agreements
   45,263    17,186    45,071    16,210 
Government grants
   847    847    810    810 
Non-compete
agreements
   110    15    110    11 
                     
Total
  $ 127,166   $ 46,190   $ 126,779   $ 43,582 
                     
 
December 31, 2019
  
September 30, 2019
 
 
Gross
Carrying
Value
  
Accumulated
Amortization
  
Gross
Carrying
Value
  
Accumulated
Amortization
 
Manufacturing technologies, core products and cell lines
 $
56,273
  $
16,057
  $
  56,193
  $
  15,096
 
Trade names, licenses and patents
  
14,596
   
6,566
   
14,494
   
6,094
 
Customer lists, customer relationships and supply agreements
  
24,500
   
14,626
   
24,274
   
14,110
 
Government grants
  
828
   
362
   
814
   
232
 
                 
Total
 $
  96,197
  $
37,611
  $
95,775
  $
35,532
 
                 
The actual aggregate amortization expense for these other intangible assets was
$2,221 and $1,722 and $829 for the three months ended December 31, 2020 and 2019, and 2018, respectively.
The estimated aggregate amortization expense for these other intangible assets for each of the fiscal years through fiscal 20252026 is as follows:
 remainder of fiscal 2020 – $5,038, fiscal 2021 – $5,491,$6,289, fiscal 2022 – $5,113,$7,993, fiscal 2023 – $5,100,$7,980, fiscal 2024 – $5,096, and$7,976, fiscal 2025 – $5,096.$7,967, and fiscal 2026 – $7,296.
9.
11
.
Bank Credit Arrangements
In anticipation of the acquisition of the business of GenePOC, (see Note 3), on May 24, 2019 the Company entered into a credit facility agreement with a commercial bank. The Company amended the credit facility whichagreement on February 19, 2020 in anticipation of the Company’s acquisition of Exalenz (see Note
6
). 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 $125,000,$160,000 (originally $125,000), with outstanding principal amounts 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 2.54% and 3.96%
on the revolving credit
 facility during the three months ended December 31, 2019.2020 and 2019, respectively. Since entering into
To
 date,the revolving credit
twofacility, three draws totaling $125,824 have been made on the credit facility, with principal repayments in January 2020, September 2020 and December 2020 of $27,000, $30,000 and $10,000, respectively, resulting in an outstanding principal balance of $75,824.$58,824
and $68,824 at December 31, 2020 and September 30, 2020, respectively. The
proceeds from these draws were used to: (i) repay and settle the outstanding principal and interest due on our previously-existingpreviously existing $60,000five-year
five-year
term loan; and (ii) along with cash
on-hand,
fund the Exalenz and GenePOC acquisition closing payment. acquisitions.
In light of the interest being determined on a variable rate basis, the fair value of the borrowings under the revolving credit facility at both December 31, 20192020 and September 30, 2020 approximates the current carrying value reflected in the accompanying Condensed Consolidated Balance Sheet.Sheets.
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 revolving credit facility agreement. As of December 31, 2019,2020, the Company iswas in compliance with all covenants.
Page 15
12.
Contingent Obligations and
Non-Current
Liabilities
In connection with the term loan repayment,acquisition of Exalenz (see Note 6), the Company also settledassumed several Israeli government grant obligations. The repayment of the grants, along with interest rate swap that had been entered into to limit exposure to volatility in the term loan’sincurred at varying stated fixed rates based on LIBOR interest rate. Atat the time of settlement,each grant was received (ranging from 0.58% to 6.60%), is not dictated by an established repayment schedule. Rather, the Company received a cash payment in an amount equalgrants and related interest are required to the $563 then-current fair valuebe repaid using 3% of the interest rate swap. Accordingly, there isrevenues generated from the sales of BreathID products, with the timing of repayment contingent upon the level and timing of such revenues. In addition, the grants have no balance for the interest rate swap reflected
within assetscollateral or liabilities within
the accompanying Consolidated Balance Sheet
s
financial covenant provisions generally associated with traditional borrowing instruments. These obligation amounts total $11,222 and $11,124 as of December 31, 2019 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 interest rate swap balance reflected within accumulated other comprehensive income at December 31, 20192020 and September 30, 2019 totaled $3842020,
respectively, and $461, respectively.are reflected in the Condensed Consolidated Balance Sheets as follows:
Page 16Current liabilities
As of December 31, 2020 – $727
As of September 30, 2020 – $600
Non-current
liabilities
As of December 31, 2020 – $10,495
As of September 30, 2020 – $10,524
Additionally, the Company has provided certain post-employment benefits to its former Chief Executive Officer, and these obligations total $1,799 and $1,840 at December 31, 2020 and September 30, 2020, respectively. In addition, the Company is required by the governments of certain foreign countries in which we operate to maintain a level of accruals for potential future severance indemnity. These accruals total $867 and $814 at December 31, 2020 and September 30, 2020,
respectively
.
 

10
13.
National Institutes of Health Contract
In December 2020, the Company entered into a sub-award grant contract with the University
of Massachusetts Medical School as part of the National Institutes of Health Rapid Acceleration of Diagnostics (“RADx”) initiative to support the Company’s research and development of its diagnostic test for the SARS-CoV-2 antigen. The Company anticipates receipt of approximately $1,000
under the grant contract
for reimbursement of eligible research and development expenditures, $800 of which has been recognized during the three months ended December 31, 2020 and is included within other income (expense) in the Condensed Consolidated Statement of Operations. The remaining amount of reimbursement funds due under the contact are currently expected to be received during the three months ending March 31, 2021.
1
4
.
Reportable Segment and Major Customers Information
Meridian was formed in 1976 and functions as a fully-integrated life science company with principal businesses in: (i)During the development, manufacture, sale and distributionthree months ended December 31, 2020, products
related
to
COVID-19
accounted for approximately 45% of diagnostic test kits, primarily for certain gastrointestinal and respiratory infectious diseases, and elevated blood lead levels; and (ii)consolidated net revenue. In addition, during the manufacture and distribution of bulk antigens, antibodies, PCR/qPCR reagents, nucleotides, and bioresearch reagents used by researchers and other diagnostic manufacturers.
Our reportable segments arethree months ended December 31, 2020, no individual 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.
Theor Life Science segment consistscustomer accounted for 10% or more of manufacturing operations in Memphis, Tennessee; Boca Raton, Florida; London, England;consolidated net revenues, with 1 Diagnostics segment customer rising to such a level of concentration (11%) during the three months ended December 31, 2019.
Page 1
6

Reportable segment revenues were concentrated as follows during the three months ended December 31, 2020 and Luckenwalde, Germany, and2019:
Three Months Ended December 31, 2020
       
   
Segment Revenue %
  
Consolidated Revenue %
 
Diagnostics
         
Customer A
   10  4
Customer B
   11  3
Customer C
   12  4
          
    33  11
          
Life Science
         
Customer D
   3  2
Customer E
   5 ��4
Customer F
   14  9
          
    22  15
          
Three Months Ended December 31, 2019
       
   
Segment Revenue %
  
Consolidated Revenue %
 
Diagnostics
         
Customer A
   15  11
Customer B
   6  4
Customer C
   12  9
          
    33  24
          
Life Science
         
Customer D
   8%��  2
Customer E
   7  2
          
    15  4
          
Accounts receivable from one of the sale and distribution of bulk antigens, antibodies, PCR/qPCR reagents, nucleotides, 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).
Amounts due from 2 Diagnostics distributorLife Science segment customers accounted for 21%6% and 13%15% of consolidated accounts receivable at December 31, 20192020 and September 30, 2019, respectively. Revenues from these two distributor customers accounted for 28% and 34% of the Diagnostics segment third-party revenues during the three months ended December 31, 2019 and 2018, respectively, and represented 20% and 24% of consolidated revenues for the fiscal 2020, and 2019 first quarters, respectively.
Page 1
7

Table of Contents
Within our Life Science segment, two
IVD
manufacturing customers accounted for 15% and 28% of the segment’s third-party revenues during the three months ended December 31, 2019 and 2018, respectively.
Segment information for the interim periods is as follows:
 
Diagnostics
  
Life Science
  
Corporate
(1)
  
Eliminations
(2)
  
Total
 
Three Months Ended December 31, 2019
 
Net revenues -
               
Third-
p
arty
 $
34,791
  $
12,630
  $
—  
  $
—  
  $
47,421
 
Inter-segment
  
97
   
65
   
—  
   
(162
)  
—  
 
Operating income
  
4,408
   
3,061
   
(2,087
)  
12
   
5,394
 
Goodwill (December 31, 2019)
  
70,415
   
19,543
   
—  
   
—  
   
89,958
 
Other intangible assets, net (December 31, 2019)
  
58,277
   
309
   
—  
   
—  
   
58,586
 
Total assets (December 31, 2019)
  
266,514
   
72,081
   
—  
   
(467
)  
338,128
 
                     
Three Months Ended December 31, 2018
 
Net revenues -
               
Third-
p
arty
 $
36,665
  $
14,815
  $
—  
  $
—  
  $
51,480
 
Inter-segment
  
163
   
176
   
—  
   
(339
)  
—  
 
Operating income
  
8,786
   
5,129
   
(3,391
)  
27
   
10,551
 
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
 
   
Diagnostics
  
Life Science
   
Corporate
(1)
  
Eliminations
(2)
  
Total
 
Three Months Ended December 31, 2020
 
Net revenues -
                      
Third-party
  $30,321  $62,596   $—    $—    $92,917 
Inter-segment
   69   18    —     (87  —   
Operating income (loss)   (1,182  39,797    (3,963  12   34,664 
Goodwill (December 31, 2020)
   94,944   19,924    —     —     114,868 
Other intangible assets, net (December 31, 2020)
   80,966   10    —     —     80,976 
Total assets (December 31, 2020)
   308,990   114,946    —     (6  423,930 
                       
Three Months Ended December 31, 2019
                      
Net revenues -
                      
Third-party
  $34,791  $12,630   $—    $—    $47,421 
Inter-segment
   97   65    —     (162  —   
Operating income (loss)   5,141   2,328    (2,087  12   5,394 
Goodwill (September 30, 2020)
   94,855   19,331    —     —     114,186 
Other intangible assets, net (September 30, 2020)
   83,179   18    —     —     83,197 
Total assets (September 30, 2020)
   306,812   98,483    —     (34  405,261 
(1)
Includes Selected Legal Costs of $1,227
in the three months ended December
 31, 2020 and Restructuring
Cost
s
Costs and Selected Legal Costs of $370 and $589
in the quartersthree months ended December 31, 2019 and 2018, respectively.2019.
(2)
Eliminations consist of inter-segment transactions.
Page 17

A reconciliation of segment operating income (loss) to consolidated earnings before income taxes for the three months ended December 31, 20192020 and 20182019 is as follows:
Three Months Ended December 31,
 
2019
 
 
2018
 
Segment operating income
 $
7,481
  $
13,942
 
Corporate expenses
  
(2,087
)  
(3,391
)
Interest income
  
111
   
149
 
Interest expense
  
(767
)  
(363
)
Other, net
  
(712
)  
139
 
         
Consolidated earnings before income taxes
 $
4,026
  
$
 
10,476
 
         
Three Months Ended December 31,
 
2020
  
2019
 
Operating income
 (loss)
:
        
Diagnostics segment
 
$
(1,182
)
 
 
$
5,141
 
Life Science segment
  
39,797
   
2,328
 
Eliminations
  
12
   
12
 
Total operating income   38,627    7,481 
Corporate expenses
  (3,963  (2,087
Interest income
  9   111 
Interest expense
  (534  (767
RADx initiative grant income
  
 
800
   
 
Other, net
  (691  (712
         
Consolidated earnings before income taxes
 $ 34,248  $ 4,026 
         
Transactions between segments are accounted for at established intercompany prices for internal and management purposes, with all intercompany amounts eliminated in consolidation.
Page 18

1
15
.
Litigation MattersIncome Taxes
On November 15, 2017, Barbara Forman filed a class action complaint in the United States District CourtThe effective rate 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 complaintincome taxes was filed on April 16, 2018 and the Company believes the essential elements of the amended complaint are the same. On July 9, 2019, a settlement was reached with the plaintiff that provides for a $2,100
payment by the Company. On October 9, 2019, the Court granted a motion for preliminary approval of the settlement, and on November 7, 2019, the settlement amount was paid from the Company’s
d
irectors and
o
fficers insurance policy into a plaintiff escrow account. The Court has scheduled a final approval hearing for March 2020. Because the settlement was a covered claim under our
d
irectors and
o
fficers insurance policy, no provision for litigation losses has been included within either of the accompanying Condensed Consolidated Statements of Operations22% for the three months ended December 31, 2019 or December 31, 2018.
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 sought compensatory damages, equitable relief relating2020, compared to corporate governance matters and attorneys’ fees. On October 9, 2019,
the
Court granted plaintiff’s motion for voluntary dismissal. Accordingly, no provision for litigation losses has been included within either of the accompanying Condensed Consolidated Statements of Operations30% for the three months ended December 31, 2019 or December 31, 2018.2019. This lower fiscal 2021 first quarter effective tax rate results primarily from a significantly higher percentage of earnings before income taxes being generated in foreign jurisdictions with tax rates lower than the U.S., particularly the
United Kingdom (“U.K.”).
 
16.
Litigation Matters
On
April 17, 2018
Meridian’s wholly-owned subsidiary, ,
Magellan Diagnostics, Inc. received
a subpoena from the United StatesU.S. 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. The Company has executed tolling agreements to extend the statute of limitations. The Company cannot predict when the investigation will be resolved, the outcome of the investigation, or its potential impact on the Company. Approximately 
$
280
1,227
and $540$
280
of expense for attorneys’ fees related to this matter is included within the accompanying Condensed Consolidated Statements of Operations for the three months ended December 31,
, 2020 and 2019,
and December 31
, 2018
, respectively.
 
Page 18
17.
Subsequent Event
E
ffective February 1
, 2021, the Company

a second grant contract under the RADx initiative, the purpose of Contentswhich is to support the Company’s manufacturing production
scale-up
and expansion to meet the demand for
COVID-19
testing. The contract is a twelve-month term service contract, with payment of up to $5,500 being made based on the Company achieving key milestones related to increasing its capacity to produce
COVID-19
tests. No amounts related to this contract are reflected within the Condensed Consolidated Financial Statements.
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.
The purpose of Management’s Discussion and Analysis is to provide an understanding of Meridian’sthe financial condition, changes in financial condition and results of operations.operations of Meridian Bioscience, Inc. (“Meridian”, the “Company”, “We”). This discussion should be read in conjunction with the financial statementsCondensed Consolidated Financial Statements and notes. It should be noted that the terms revenue and/or revenues are utilized throughout the Management’s Discussion and Analysis of Financial Condition and Results of Operations to indicate net revenue and/or net revenues.
Reportable Segments
Our reportable segments are Diagnostics and Life Science. The Diagnostics segment consists of manufacturing operations for infectious disease products in Cincinnati, Ohio; Quebec City, Canada; and Modi’in, Israel; 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”). 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, 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.
Page 19
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. In January 2021, the United States (“U.S.”) Department of Health and Human Services extended the public health emergency declaration for
COVID-19
into April 2021. Governments around the world have implemented lockdown and
shelter-in-place
orders, requiring many
non-essential
businesses to shut down operations, many of which remain in effect as of the date of this filing. Our business, however, was deemed “essential” and we have continued to operate, manufacture and distribute products to customers globally. We have developed a comprehensive plan that enables us to maintain operational continuity with an emphasis on 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 in real-time as needed.
The
COVID-19
pandemic has had both positive and negative effects on our businesses. Our Life Science segment’s products were well positioned to respond to
in-vitro
device (“IVD”) manufacturers’ needs for reagents for molecular, rapid antigen and serology tests. Consequently, our Life Science segment grew its revenues over 100% in fiscal 2020 and delivered record operating income and margin, demonstrating what this segment could achieve at a much larger scale. This level of growth has continued to increase into fiscal 2021 for the Life Science segment, with first quarter fiscal 2021 revenue exceeding the fiscal 2020 first quarter level by nearly 400%. Our Diagnostics segment, on the other hand, reported decreased year-over-year revenues in the first quarter of fiscal 2021, a continuation of the trends experienced in the third and fourth quarters of fiscal 2020, as health systems focus on
SARS-CoV-2
testing over traditional infectious disease and blood-chemistry testing. Following signs of a recovery in our Diagnostics segment late in fiscal 2020, as evidenced by a 38% sequential quarter increase in the fourth quarter of fiscal 2020, and which continued throughout the early part of the first quarter of fiscal 2021, the recent resurgence of the pandemic resulted in first quarter fiscal 2021 Diagnostic segment revenues growing only 2% from the fourth quarter of fiscal 2020, and down 13% from the first quarter of fiscal 2020.
Employee Safety
We have implemented a work-from-home process for employees whose
on-site
presence is designated as
non-essential
to the ongoing functions of our manufacturing sites, distribution centers, and new product development facilities. We continue to utilize this work-from-home process as needed on a
site-by-site
basis. We also implemented enhanced cleaning and sanitizing procedures and provided additional personal hygiene supplies at all of our sites. We implemented policies for employees to adhere to the Centers for Disease Control and Prevention (“CDC”) guidelines on social distancing, and similar guidelines by authorities outside the U.S., 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, including a negative active infection test result. Access to our facilities by outside persons not critical to continuing our operations continues to be limited. To date, we have been able to manufacture and distribute products globally, and all our sites continue to operate, with little, if any, impact on shipments to customers to date. As the pandemic continues to spread, along with continuing governmental restrictions which vary by locale and jurisdiction, there is an increased risk of employee absenteeism, which could materially impact our operations at one or more sites. To date, the steps we have taken, including 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
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 regularly communicate with suppliers, third-party partners, customers, health care providers 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.
Page 20

Clinical Trial Delays
As a result of the pandemic, certain of our clinical trials which were underway or scheduled to begin were temporarily placed on hold. While we are seeing
“re-starts”
for certain clinical trials, the trials are being conducted at a slower pace than normal, as the prevalence of certain infectious diseases (e.g., bacterial gastrointestinal) has been much lower than historical norms during the pandemic. Such delays continue to 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 ongoing
COVID-19
pandemic has and could continue to 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 molecular and immunological reagents to IVD customers, including those who are making both molecular and immunoassay
COVID-19
tests. Since late in the second quarter of fiscal 2020, we have experienced unprecedented demand for certain of our molecular reagents (e.g., ribonucleic acid (“RNA”) master mixes and nucleotides). Although we are unable to predict when this demand may subside, we expect revenue levels for these products to be materially higher than historical levels during at least the next six to nine months. Our products are used in over 100 approved
COVID-19
related assays around the world. COVID-related reagent revenues totaled approximately $43,000 in the fiscal 2021 first quarter, following approximately $71,500 during full year fiscal 2020.
Our Diagnostics segment manufactures, markets and sells a number of molecular, immunoassay, blood chemistry and urea breath tests
for various infectious diseases and blood-lead levels. We expect near-term sales volumes for a number of these assays to continue to be adversely affected by the
COVID-19
pandemic as such assays are often used in
non-critical
care settings. The
COVID-19
pandemic also has continued to affect our instrument placements. The launch of our Curian platform has been slower than expected as diagnostic testing sites have turned their attention to critical care testing. However, beginning in our fiscal 2020 fourth quarter and continuing through the fiscal 2021 first quarter, we have experienced an acceleration in Revogene instrument placements due to the January 2021 launch of a
SARS-CoV-2
assay (the “Revogene
COVID-19
assay”) under the FDA’s emergency use authorization (“EUA”) program, which permits sales to commence upon notification of intent to submit an EUA application. We submitted our application for EUA to the FDA on December 7, 2020 and expect to receive approval of the submission during our fiscal 2021 second quarter. In response to the high level of demand we are experiencing for the test, we are in the process of increasing our capacity to produce these tests, as well as other tests on the Revogene system. Specifically, we are: (i) adding a second production line at our Quebec City, Canada manufacturing facility; and (ii) installing two additional production lines in a leased facility near our corporate headquarters in Cincinnati, Ohio. It is expected that these expansion efforts will be completed during fiscal 2021 at a total cost of approximately $18,000, which is expected to be partially offset by the $5,500 RADx grant entered into on February 1, 2021 (see Note 17 of the accompanying Condensed Consolidated Financial Statements).
As previously described, signs of a recovery in our Diagnostics segment were experienced late in fiscal 2020 and early in the first quarter of fiscal 2021. However, as a result of the recent resurgence of
COVID-19
infection rates, during the first quarter of fiscal 2021 Diagnostic segment revenues increased only 2% from the level achieved in the fourth quarter of fiscal 2020, and were down 13% from the first quarter of fiscal 2020. While we are expecting a modest rebound in Diagnostic segment revenues in the upcoming months, including revenue from the Revogene
COVID-19
assay, no assurances can be made in this regard.
Asset Impairment Review
Considering the economic impacts of
COVID-19,
we performed an analysis of our business to determine if there were triggering events that would require us to further test our long-lived assets for impairment. 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 long-lived assets. As such, no impairments or other write-downs related to
COVID-19
have been recorded during the fiscal 2021 first quarter or prior year period.
Access to Capital
The impacts of
COVID-19
have adversely affected the ability of many companies to access capital and liquidity on favorable terms or at all. As of December 31, 2020, the outstanding debt balance on the Company’s revolving credit facility was $58,824, leaving $101,176 of available borrowing capacity. In addition, positive cash flows from operating activities are expected to be generated over the next twelve months, which will add to cash on hand. We
Page 21

also maintain a shelf registration statement on file with the SEC. The Company believes these resources will provide sufficient liquidity and cash flows to meet its operating and debt service requirements for at least the next twelve months and expects to be in compliance with its financial covenants during this same period. However, given the unusual nature of the
COVID-19
pandemic and the rapidly changing environment, we can provide no assurances in this regard and future impacts may materialize that are not currently known.
Critical Accounting Estimates
For the three months ended December 31, 2020, there were no significant changes to our critical accounting estimates, as outlined in our Annual Report on Form
10-K
as of and for the
year-end
September 30, 2020.
Impact of Brexit
The United Kingdom (“U.K.”) left the European Union (“EU”) on January 31, 2020. While all EU rules and laws continued to apply to the U.K. through the transition period, which ended December 31, 2020, the U.K. and the EU reached a free trade agreement on December 24, 2020, which included regulatory and customs cooperation mechanisms, as well as provisions supporting open and fair competition. Under the trade agreement, the U.K. is free to set its own trade policy and can negotiate with other countries that do not currently have free trade deals with the EU. Although the full impact of the trade agreement is uncertain, it is possible that the recent changes to the trading relationship between the U.K. and the EU due to the trade agreement could result in increased cost of goods imported into and exported from the U.K., which may decrease the profitability of our operations. Additional currency volatility could drive a weaker British pound, which could increase the cost of goods imported into the U.K. and may decrease the profitability of our operations. A weaker British pound versus the U.S. dollar may also cause local currency results of our operations to be translated into fewer U.S. dollars during a reporting period. Given the lack of comparable precedent, it is unclear what financial, trade, regulatory and legal implications the trade agreement will have on our business; however, Brexit and its related effects could potentially have an adverse impact on our financial position and results of operations.
The U.K.’s withdrawal from the EU could also adversely impact the operations of our vendors and of our other partners. Our management team has evaluated a range of possible outcomes, identified areas of concerns, and implemented strategies to help mitigate these concerns. It is possible that these strategies may not be adequate to mitigate any adverse impacts of Brexit, and that these impacts could further adversely affect our business and results of operations.
RESULTS OF OPERATIONS
Three Months Ended December 31, 2019
2020
Net earnings for the first quarter of fiscal 2020 decreased 65%2021 increased 847% to $2,827,$26,779, or $0.07$0.61 per diluted share, from net earnings for the first quarter of fiscal 20192020 of $8,106,$2,827, or $0.19$0.07 per diluted share. The level of net earnings in the fiscal 2021 first quarter of fiscal 2020 was affected by several factors, including: (i) lower overall revenues in bothincluding most notably the Diagnostics and Life Science operating segments; (ii) contractual pricing declines in certain gastrointestinal products within the Diagnostics segment; (iii) higher research and development spending in the Diagnostics segment ($1,030
pre-tax);
(iv) purchase accounting amortization related to the acquisitioncombined net effects of the GenePOC businessfollowing (amounts presented on a
pre-tax
basis) and a lower effective tax rate resulting from a greater percentage of pre-tax earnings being generated in June 2019 ($855lower tax jurisdictions:
pre-tax);
(v) an increase in the fair value
(i)
significantly higher revenues in the Life Science segment, due to supplying key molecular components and antibodies to diagnostic test manufacturers for use in
COVID-19
related PCR and antibody tests (up $49,966);
(ii)
higher research and development spending in the Diagnostics segment (up $895) under new product development programs;
(iii)
increased cash-based incentive compensation (up $600) tied to higher revenues and profit levels;
(iv)
increased intangible asset amortization, primarily resulting from purchase accounting amortization related to the acquisition of Exalenz in April 2020 (up $499);
(v)
increased legal expenses related to the DOJ matter at the Billerica, Massachusetts facility (up $947) (see “Lead Testing Matters” below); and
Page 22

pre-tax);
(vi)
the fiscal 2021 first quarter including $800 in grant income related to the National Institutes of Health RADx initiative (see Note 13 of the accompanying Condensed Consolidated Financial Statements).
and (vi) higher interest costs under our revolving credit facility.
Consolidated revenues for the first quarter of fiscal 20202021 totaled $47,421, a decrease$92,917, an increase of 8%96% compared to the first quarter of fiscal 2019 (7% decrease2020 (93% increase on a constant-currency basis).
Revenues for the Diagnostics segment for the first quarter of fiscal 20202021 decreased 5%13% compared to the first quarter of fiscal 2019 (also 5%2020 (14% on a constant-currency basis), comprised of a 5%34% decrease in molecular assay products and a 5%an 8% decrease in immunoassay and blood chemistrynon-molecular assay products. Customer account losses inAs previously noted, despite the
COVID-19
pandemic continuing to dramatically slow sales of our molecular assay products slowed dramatically during the quarter, with our Revogene system install base reaching 114 systems. Revenues for our Life Science segment decreased 15% during the first quarter of fiscal 20202021, the acceleration of Revogene instrument placements in anticipation of the Revogene
COVID-19
assay under the FDA’s EUA program resulted in 57 net placements of our Revogene system during the first quarter of fiscal 2021 and a total Revogene system install base of 288 systems as of December 31, 2020. With a 758% increase in revenues from molecular reagents products and a 128% increase in revenues from immunological reagents products, revenues for our Life Science segment increased 396% during the first quarter of fiscal 2021 compared to the first quarter of fiscal 2019 largely due to order patterns and inventory management with our top IVD manufacturing customers.2020. On a constant-currency basis, revenues for the Life Science segment decreased 14%increased 387%. Life Science segment revenues reflect a significant increase in the sales of key molecular components such as RNA master mixes and deoxyribonucleotide triphosphates (“dNTPs”) to diagnostic test manufacturers for use in
COVID-19
related PCR tests. Also contributing to the record revenue levels during the first quarter of fiscal 2021 were sales of monoclonal antibody pairs used in COVID-19 antigen tests and, to a lesser degree, recombinant antigens used in
COVID-19
antibody tests. In addition, our core Life Science segment business (other than
COVID-19
contributions) experienced growth of approximately $7,000, or approximately 55%, compared to the first quarter of fiscal 2020. This growth, including an approximate 88% increase in revenues from sales into China, resulted in large part from obtaining business from
COVID-19
customers who are now using our products for other
non-COVID
related purposes, as well as a rebound in volumes in core immunological products.
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 a related Warning Letter on October 23, 2017. On April 17, 2018, Magellan received a subpoena from the United StatesU.S. 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. We have executed tolling agreements 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 had been put on Additional Information hold. On July 15, 2019, we provided responses to the FDA’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 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 including review by an FDA Advisory Committee, to determine whether further action by the FDA or the Centers for Disease Control and PreventionCDC is necessary to protect the public health. Meridian intends to fully cooperate with the FDA as the third-party study and Advisory Committee review areis completed.
Page 19

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,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. Over the last year, we have submitted a number of written responses to the FDA our written responses toregarding the five Form FDA 483 observations issued in the October 2019 inspection, and have implementedworked diligently to execute a remediation plan that we are actively working. In Januaryplan. During October 2020, we submitted to the FDA additional written responses toissued Establishment Inspection Reports which closed out the Forminspections from June 2017 and October 2019 under 21 C.F.R.20.64 (d) (3). The Warning Letter issued in October 2017 remains outstanding, pending a future FDA 483 observations.inspection. 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.
Page 23

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, andand/or 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,revenues, provided for each of the following:
 -
By Reportable Segment & Geographic Region
 
 -
By Product Platform/Type
Revenue Overview- By Reportable Segment & Geographic Region
Our reportable segments are Diagnostics and Life Science. 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”). 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, 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 (including the
COVID-19
pandemic), and foreign currency exchange rates. Revenues for the Life Science segment, in the normal course of business, may be affected from quarter to quarter by buying patterns of major IVD manufacturing customers, severity of disease outbreaks and foreign currency exchange rates. The severity of the
COVID-19
pandemic contributed approximately $71,500 of new revenue for our Life Science segment during fiscal 2020, and approximately $43,000 during the first quarter of fiscal 2021.
See the “Revenue Disaggregation” section of Note 2,4,
Significant Accounting Policies”Revenue Recognition”
of the accompanying Condensed Consolidated Financial Statements for detailed revenue disaggregation information.
Following is a discussion of the revenues generated by these product platforms/types and/or disease states:
Diagnostics Segment Products
The acquisitionacquisitions of the Revogene molecular diagnostics platform and the BreathID breath test system, 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 convertingcontinue to convert 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. Our currentAs previously noted, despite the
COVID-19
pandemic continuing to dramatically slow sales of our molecular assay products during the first quarter of fiscal 2021, the acceleration of Revogene instrument placements in anticipation of the Revogene
COVID-19
assay under the FDA’s EUA program resulted in 57 net placements of our Revogene system during the first quarter of fiscal 2021 and a total Revogene system install base forof 288 systems as of December 31, 2020. In March 2020, we received clearance from the Revogene system has reached 114. ForFDA for the Curian immunoassay diagnostics platform, we submitted a 510(k) for the instrument and its first assay, a test for
H. pylori
antigen in stool, in September 2019, which westool. We expect to be clearedbegin clinical trials for marketingthe Curian
C. difficile
Common Antigen and Toxins A and B test in the first half of calendar 2020.February 2021. We believe the advantages of the Curian analyzer will help protect our existing rapid test accounts.
Page 20
accounts, and in the case of the
C. difficile
test, provide meaningful revenue growth opportunities.

Gastrointestinal, Respiratory Illness and Blood Chemistry Assays
As previously noted, the ongoing
COVID-19
pandemic has had a negative impact on revenue levels from sales of our gastrointestinal, respiratory illness and blood chemistry products. During the first quarter of fiscal 2020,2021, revenues from oureach of these product categories decreased from fiscal 2020 first quarter levels as follows: (i) gastrointestinal products, which include tests for
C. difficile
,
H. pylori
and certain foodborne pathogens, among others, totaled $16,046. This represents a 14% decrease from the first quarterdecreased 5% to $15,452; (ii) respiratory illness products, which include tests for Group A Strep, Mycoplasma pneumonia, Influenza, and Pertussis, among others, decreased 38% to $4,806; and (iii) blood chemistry products, which test for elevated levels of fiscal 2019. This decrease resultslead in large part fromblood, decreased 11% to $4,394.
Page 24

In order to combat certain of the pricing and volume pressures we continue to face within thisthe gastrointestinal product category. Wecategory, we have executed on a number of measures including: (i) entering into a strategic collaboration with DiaSorin to sell
H. pylori
tests; (ii) executing multi-year supply agreements with our two largest reference laboratory customers for
H. pylori
tests to secure volume, albeit at lower selling prices. We continue to believe there are ongoing benefits to be realized 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;prices; and (iii) physician behavior movement away from serology-based testing.
Contributingupon FDA clearance in March 2020, launching Curian HpSA, our first assay on the Curian platform, which we expect will help protect our existing customer base using lateral flow tests. We also expect the acquisition of the Exalenz BreathID platform to thecombat competitive pressures, being facedas we believe that we are now the only company with
FDA-cleared,
non-invasive
assays for both stool antigen and urea breath samples, providing physicians a choice in this product 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, 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 initiatives for the detection of
H. pylori
, and early in the first quarter of fiscal 2019 we entered intotest format from a strategic collaboration with DiaSorin to sell
H. pylori
tests.single supplier. 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 tests for influenza, RSV, Group A Strep, Pertussis, and Mycoplasma pneumonia, among others, our respiratory illness product revenues decreased 3% in the fiscal 2020 first quarter, primarily related to lower sales volumes.
Blood Chemistry Assays
Revenues from our sale of products to test for elevated levels of lead in blood increased 16% during the first quarter of fiscal 2020 to a total of $5,150.
Life Science Segment Products
During the first quarter of fiscal 2020,2021, revenues from our Life Science segment decreased 15%increased 396%, with revenues from molecular reagent sales decreasing 19%increasing 758% from the comparable fiscal 20192020 quarter and revenues from immunological reagent sales decreasing 11%increasing 128%. Our Life Science segment’s revenue performance was slightlynominally impacted by the movement in currency exchange rates since the first quarter of fiscal 2019,2020, with revenues decreasing 14%increasing 387% on a constant-currency basis over the first quarter of fiscal 2019.2020. The declineincrease in revenues was largelyprimarily attributable to order patternssales of key molecular components such as RNA master mixes and inventory management with our top IVD manufacturing customers. Revenuedeoxyribonucleotide triphosphates (“dNTPs”) to diagnostic test manufacturers for use in
COVID-19
related PCR tests, as well as sales into Chinaof monoclonal antibody pairs used in antigen tests and to a lesser degree, recombinant antigens used in
COVID-19
antibody tests. COVID-related reagent revenues totaled approximately $1,800, increasing 70%$43,000 during the first quarter of fiscal 2021.
Revenue from core Life Science segment business (other than
COVID-19
contributions) grew approximately 55% over the first quarter of fiscal 2019. While not reflected within the fiscal 2020 first quarter results, during January 2020,to approximately $19,500. This growth, including an approximate 88% increase in revenue from sales into China, resulted in large part from obtaining business from
COVID-19
customers who are now using our Life Science segment began shipping molecular reagents to IVD manufacturing customersproducts for other
non-COVID
related purposes, as well as a rebound in China to help health care systemsvolumes in that country combat the Coronavirus outbreak.
core immunological products.
Significant Customers
Revenue concentrations related to certain customers within our Diagnostics and Life Science segments are set forth in Note 1014 of the accompanying Condensed Consolidated Financial Statements.
Gross Profit
             
 
Three Months Ended December 31,
 
 
2019
  
2018
  
Change
 
Gross Profit
 $
 27,440
  $
 31,572
   
(13)
%
Gross Profit Margin
  
58
%  
61
%  
-3 points
 
 
   
Three Months Ended December 31,
 
   
2020
  
2019
  
Change
 
Gross Profit
  $61,548  $ 27,651   123
Gross Profit Margin
   66  58  8 points 
The increase in gross profit margin during the first quarter of fiscal 2021 results primarily from the overall shift in sales mix the Company has experienced, largely as a result of the
COVID-19
pandemic. During first quarter of fiscal 2021, approximately 50% of consolidated revenues relate to sales of molecular reagent products, which are some of our higher margin products, as compared to sales of such products comprising only approximately 11% of consolidated revenues during the first quarter of fiscal 2020.
 
Page 2125

The overall gross profit margin decrease during the first quarter of fiscal 2020 primarily results from the combined effects of: (i) previously-noted pricing changes within our
H. pylori
product line; (ii) mix of products sold, particularly decreased contribution from certain of our higher margin gastrointestinal assays; and (iii) production capacity
ramp-up
costs for our newly acquired Quebec facility where Revogene instruments and test devices are made.
Operating Expenses - Segment Detail
                     
 
Research &
Development
  
Selling &
Marketing
  
General &
Administrative
  
Other
  
Total Operating
Expenses
 
Fiscal 2019 First Quarter:
 
Diagnostics
 $
3,196
  $
6,041
  $
4,609
  $
—  
  $
13,846
 
Life Science
  
771
   
1,522
   
1,491
   
—  
   
3,784
 
Corporate
  
—  
   
—  
   
2,802
   
589
   
3,391
 
                     
Total 2019 First Quarter Expenses
 $
3,967
  $
7,563
  $
8,902
  $
589
  $
21,021
 
                     
Fiscal 2020 First Quarter:
 
Diagnostics
 $
4,226
  $
5,339
  $
5,478
  $
1,317
  $
16,360
 
Life Science
  
598
   
1,345
   
1,561
   
95
   
3,599
 
Corporate
  
   
   
1,717
   
370
   
2,087
 
                     
Total 2020 First Quarter Expenses
 $
4,824
  $
6,684
  $
8,756
  $
1,782
  $
22,046
 
                     
  
Operating Expenses - Comparison to Prior Year Periods
 
                
 
Research &
Development
  
Selling &
Marketing
  
General &
Administrative
  
Other
  
Total Operating
Expenses
 
2019 First Quarter Expenses
 $
3,967
  $
7,563
  $
8,902
  $
589
  $
21,021
 
                     
% of Revenues
  
8
%  
15
%  
17
%  
1
%  
41
%
Fiscal 2020 Increases (Decreases):
 
Diagnostics
  
1,030
   
(702
)  
869
   
1,317
   
2,514
 
Life Science
  
(173
)  
(177
)  
70
   
95
   
(185
)
Corporate
  
—  
   
—  
   
(1,085
)  
(219
)  
(1,304
)
                     
2020 First Quarter Expenses
 $
4,824
  $
6,684
  $
8,756
  $
1,782
  $
22,046
 
                     
% of Revenues
  
10
%  
14
%  
18
%  
4
%  
46
%
% Increase (Decrease)
  
22
%  
(12
)%  
(2
)%  
203
%  
5
%
 
   
Research &
Development
   
Selling &
Marketing
   
General &
Administrative
   
Other
   
Total Operating
Expenses
 
Fiscal 2020 First Quarter:
                         
Diagnostics
  $4,175   $5,396   $4,929   $1,317   $15,817 
Life Science
   588    1,332    2,338    95    4,353 
Corporate
   —      —      1,717    370    2,087 
                          
Total 2020 First Quarter Expenses
  $4,763   $6,728   $8,984   $1,782   $22,257 
                          
Fiscal 2021 First Quarter:
                         
Diagnostics
  $5,070   $5,728   $5,748   $1,047   $17,593 
Life Science
   581    1,293    3,454    —      5,328 
Corporate
   —      —      2,736    1,227    3,963 
                          
Total 2021 First Quarter Expenses
  $5,651   $7,021   $11,938   $2,274   $26,884 
                          
Operating Expenses – Comparison to Prior Year Periods
 
   
Research &
Development
  
Selling &
Marketing
  
General &
Administrative
  
Other
  
Total Operating
Expenses
 
2020 First Quarter Expenses
  $4,763  $6,728  $8,984  $1,782  $22,257 
% of Revenues
   10  14  19  4  47
Fiscal 2021 Increases (Decreases):
                     
Diagnostics
   895   332   819   (270  1,776 
Life Science
   (7  (39  1,116   (95  975 
Corporate
   —     —     1,019   857   1,876 
                      
2021 First Quarter Expenses
  $5,651  $7,021  $11,938  $2,274  $26,884 
                      
% of Revenues
   6  8  13  2  29
% Increase
   19  4  33  28  21
The changes in operating expenses primarily reflect the combined effects of the following:
Increased Research & Development costs, primarily forreflecting the development of the Revogene system GImolecular
SARS-CoV-2
assay and RImolecular gastrointestinal and respiratory panel assays for the Diagnostics operating segment;segment, and the addition of research and development expenses related to Exalenz, acquired in April 2020;
Decreased
Increased Selling & Marketing costs, primarily reflecting increased bonus and commissions paid to sustain the Diagnostics segment sales force during the downturn caused by the
COVID-19
pandemic, partially offset by the effects of reorganizationreduced travel from restrictions imposed during the pandemic and streamlining initiatives;the effect such restrictions have had on general sales and marketing activities;
Decreased
Increased General & Administrative costs, primarily reflecting additional investment in incentive compensation, along with the effectsaddition of reorganizationexpenses related to Exalenz, including purchase accounting amortization; and streamlining initiatives,
Increased Selected Legal Costs, partially offset by the purchase accounting amortization from the acquisition of the GenePOC business; and
Page 22

Increaseda decrease in restructuring costs and a changedecrease in the effect of changes in the fair value of the contingent consideration obligation for the GenePOC business partially offset by a decrease in selected legal costs (reflected within “Other” in the above tables).
 
Page 26

Operating Income
Operating income decreased 49%increased 543% to $5,394$34,664 for the first quarter of fiscal 2020,2021, as a result of the factors discussed above.
Income Taxes
The effective rate for income taxes was 22% for the first quarter of fiscal 2021, compared to 30% for the first quarter of 2020. This lower fiscal 2020, compared to 23% for the first quarter of 2019. This higher fiscal 20202021 tax rate results primarily from thea significantly higher percentage of pretax income being generated in in foreign jurisdictions with tax impact of restricted share units lapsing on a date when the share price was significantlyrates lower than the share price onU.S., particularly 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 for the full fiscal year to approximate 23.5% to 24.5%.U.K.
Liquidity and Capital Resources
Liquidity
Our cash flow and financing requirements are determined by analyses of operating and capital spending budgets and debt service, and consideration of common share dividends.service. We have historically maintained a credit facility to augment working capital requirements and to respond quickly to acquisition 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 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 worldwide
geo-political
and
geo-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 $125,000$160,000 bank revolving credit facility, which totaled approximately $49,200$101,200 as of December 31, 2019.2020. 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.
During the first quarter of fiscal 2021, we generated cash flow from operations totaling $25,121. This level of cash resulted from the achievement of record quarterly revenues, along with well-managed accounts receivable balances, including the requirement of advance payments in certain instances, as illustrated by an approximate 45% increase in consolidated revenues over the fourth quarter of fiscal 2020 and only an approximate 6% increase in accounts receivable balances since September 30, 2020.
Our levels of inventories increased approximately $6,000 to $67,243 between September 30, 2020 and December 31, 2020. This increase was attributable to inventory builds in both our Diagnostics and Life Science segments to protect against future supply interruptions and to meet
COVID-19
related demand. For our Diagnostics segment, we also have maintained inventory levels in anticipation of a return to
pre-pandemic
diagnostic testing activity. We are continuing to actively manage our inventory levels.
As of December 31, 2019,2020, our cash and cash equivalents balance was $68,557$63,193 or $7,034 higher than at the end of the fiscal 2019 first quarter, and $6,160$9,679 higher than at the end of fiscal 2019. This increase results in large part from2020. As a result of the cash flowsgenerated from operating activities being more than sufficientoperations during the first quarter of fiscal 2021, our balance of net debt (defined as bank debt, government grant obligations and total contingent obligations related to cover capital expendituresthe acquisition of the GenePOC business, net of cash and debt service.equivalents
on-hand)
decreased approximately $23,500 to approximately $28,800 at December 31, 2020. Net cash flows from operating activities and cash on hand are anticipated to be adequate to fund working capital requirements, capital expenditures and debt service during the next 12twelve 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 new product development activities for the Revogene molecular diagnostic platform, as well as the Curian and PediaStat platforms, among other investments, and to preserve capital resources and liquidity for general corporate purposes.
Page 23

Capital Resources
As described in Note 9,11,
“Bank Credit Arrangements”
of the accompanying Condensed Consolidated Financial Statements, on May 24, 2019, in connection with the acquisition of the GenePOC business, the Company executedmaintains a five-year $125,000$160,000 revolving credit facility, to replace our previously-existing $30,000 credit facility. The current credit facilitywhich is secured by substantially all of our U.S. assets and includes certain restrictive financial covenants. AsThe Company also maintains a shelf registration statement on file with the SEC.
Page 27

Our capital expenditures are estimated to range between approximately $4,000 to $5,000 for fiscal 2020, with$18,000 and $23,000. Our Diagnostics segment capital expenditures could be as high as $20,000, depending upon the actual amount dependent upon actual operating resultslevel and timing of the phasing of certain projects.previously noted Revogene
COVID-19
assay production capacity expansion and
scale-up
efforts, and our Life Science segment capital expenditures could be as high as $3,000, reflecting manufacturing capacity expansion at various locations. Such expenditures may be funded with cash and cash equivalents on hand, operating cash flows and/or availability under the $125,000$160,000 revolving credit facility discussed above. In addition, a portion of the Diagnostics segment expansion may be funded by the previously noted $5,500 RADx grant entered into on February 1, 2021 (see Note 17 of the accompanying Condensed Consolidated Financial Statements).
We do not utilize any special-purpose financing vehicles or have any undisclosed
off-balance
sheet arrangements.
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
There have been no material changes in the Company’s exposure to market risk since September 30, 2019.2020.
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 December 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 December 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 December 31, 20192020 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
PART II. OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
See Note 11,16,
“Litigation Matters”
of the accompanying Condensed Consolidated Financial Statements.
ITEM 1A. RISK FACTORS
There have been no material changes from risk factors as previously disclosed in the Company’s fiscal 20192020 Annual Report on Form
10-K
in response to Item 1A to Part I of Form
10-K
, except that we are updating the following risk factor discussion relating to global economic conditions in response to the January 31, 2020 departure of the United Kingdom (“UK”) from the European Union (“EU”).
Page 2410-K.

We face risks related to global economic conditions.
We currently generate significant operating cash flows, which combined with access to the credit markets, provides us with discretionary funding capacity for research and development and other strategic activities. However, as an enterprise with global operations and markets, our operations and financial performance are in part dependent upon global economic conditions, and we could be negatively impacted by a global, regional or national economic crisis, including sovereign risk in the event of deterioration in the credit worthiness of or a default by local governments. We are particularly susceptible to the economic conditions in countries where government-sponsored health care systems are the primary payers for health care, including those countries within the EU that are reducing their public expenditures in an effort to achieve cost savings. The uncertainty in global economic conditions poses a risk to the overall economy that could impact demand for our products, as well as our ability to manage normal commercial relationships with our customers, suppliers and creditors, including financial institutions. As such, if global economic conditions deteriorate significantly, our business could be negatively impacted, including such areas as reduced demand for our products from a slow-down in the general economy, supplier or customer disruptions resulting from tighter credit markets, and/or temporary interruptions in our ability to conduct day-to-day transactions through our financial intermediaries involving the payment to or collection of funds from our customers, vendors and suppliers. While to-date such factors have not had a significant negative impact on our results or operations, we continue to monitor and plan for the potential impact of these global economic factors.
In June 2016, a majority of voters in the UK elected to withdraw from the EU, in a national referendum (commonly referred to as Brexit). The UK left the EU on January 31, 2020, which has initiated an 11-month transition period by which the UK is to leave the single market and customs union. The withdrawal has created significant uncertainty about the future relationship between the UK and the EU. The withdrawal by the UK has also given rise to calls for the governments of other EU member states to consider withdrawal. These developments, or the perception that any of them could occur, have had and may continue to have a material adverse effect on global economic conditions and the stability of global financial markets, and may significantly reduce global market liquidity and restrict the ability of key market participants to operate in certain financial markets. The withdrawal has also created uncertainty with regard to the regulation of data protection in the UK. In particular, it is unclear how the UK’s withdrawal will affect the UK’s enactment of the European General Data Protection Regulation, and how data transfers to and from the UK will be regulated following any transition period. The UK’s withdrawal may have adverse practical or operational implications on our business. Any of these factors could depress economic activity and restrict our access to capital, which could have a material adverse effect on our business, financial condition and results of operations and reduce the price of our common stock.
Due to the fact that we have operations located within the UK, Brexit could negatively impact our operations resulting primarily from: (a) operational disruptions due to changes in the manner in which people and products are moved between the UK and EU following Brexit; (b) changes in the regulatory regime governing our products once the UK is no longer under the umbrella EU scheme; and (c) potential price increases for supplies purchased by our UK businesses from companies located in the EU or elsewhere.
Further, due to Brexit, the value of the British Pound Sterling incurred significant fluctuations. Additionally, further actions related to Brexit may occur in the future. If the value of the British Pound Sterling continues to incur similar fluctuations, unfavorable exchange rate changes may negatively affect the value of our operations and businesses located in the UK, as translated to our reporting currency, the United States Dollar, in accordance with U.S. GAAP, which may impact the revenue and earnings we report. Continued fluctuations in the British Pound Sterling may also result in the imposition of price adjustments by EU-based suppliers to our UK businesses, as those suppliers seek to compensate for the changes in value of the British Pound Sterling as compared to the European Euro. Any of these results could have a material adverse effect on the business, revenues and financial condition of our UK and European operations.
Page 25

ITEM 6. EXHIBITS
The following exhibits are being filed or furnished as a part of this Quarterly Report on Form
10-Q10-Q:
:
10.1*†  
10.1*
  
10.2*†  Executive Vice President Cash-Based Incentive Compensation Plan for Fiscal Year 2021
Page 28

10.3Amendment to Share Purchase Agreement dated as of June 3, 2019, between Apres-Demain Inc. (formerly known as GenePOC Inc.), Meridian Bioscience Canada, Inc., Apres-Demain SA in its capacity of Shareholders’ Representative, and Meridian
  
10.4*
31.1
Amendment No. 3 to Share Purchase Agreement dated as of December 21, 2020, between Apres-Demain Inc. (formerly known as GenePOC Inc.), Meridian Bioscience Canada, Inc., Apres-Demain SA in its capacity of Shareholders’ Representative, and Meridian
  
16.1
Letter from Grant Thornton LLP dated December 28, 2020 (Incorporated by reference from the Company’s Form 8-K filed with the SEC on December 30, 2020)
31.1Certification of Principal Executive Officer Pursuant to Securities Exchange Act Rule 13a-14(a)/15d-14(a)
  
31.2  
31.2
  
32  
32
  
101.INS  Inline XBRL Instance Document
  
101.INS
101.SCH
  
Inline XBRL Instance Document
Extension Schema
  
101.CAL  
101.SCH
Inline XBRL Instance Extension Schema
101.CAL
Inline XBRL Instance Extension Calculation Linkbase
  
101.DEF  
101.DEF
Inline XBRL Instance Extension Definition Linkbase
  
101.LAB  
101.LAB
Inline XBRL Instance Extension Label Linkbase
  
101.PRE  
101.PRE
Inline XBRL Instance Extension Presentation Linkbase
  
104  
104
Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101)
 
*
Certain portions of this exhibit have been omitted pursuant to Item 601(b)(2) of Regulation
S-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 portion to the SEC upon request.
Management Compensatory Agreement
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
      
MERIDIAN BIOSCIENCE, INC.
Date:
February 5, 2021
By:
/s/ Bryan T. Baldasare
      Bryan T. Baldasare
Date:
February 7, 2020
  
By:
/s/ Bryan T. Baldasare
Bryan T. Baldasare
 
Executive Vice President and Chief Financial Officer
(Principal Financial and Accounting Officer)
 
Page 2629