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 MarchDecember 31,
2021
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)
  
Name of each exchange

on which registered
Common Stock, no par value
  
VIVO
  
NASDAQ Global Select Market
Indicate by a check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past
90 days.    
Yes
  ☒    No  ☐
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation
S-T
(§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such
files).    
Yes
  ☒    No  ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a
non-accelerated
filer, smaller reporting company, or an emerging growth company. See definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule
12b-2
of the Exchange Act.
 
Large accelerated filer   Accelerated filer 
    
Non-accelerated filer   Smaller reporting company 
    
Emerging growth company      
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule
12b-2
of the Exchange Act).     Yes  ☐    No  
Indicate the number of shares outstanding of each of the issuer’s classes of common stock, as of the latest practicable date.
 
Class
 
Outstanding April 30, 2021
January 31, 2022
Common Stock, no par value 43,330,03843,541,412

MERIDIAN BIOSCIENCE, INC. AND SUBSIDIARIES
TABLE OF CONTENTS TO QUARTERLY REPORT ON FORM
10-Q
 
      
Page(s)
 
PART I.
    
Item 1.
    
 
   1 
 
   2 
 
   3 
 
   
4-5
 
 
   6 
 
   7-20
7-16
 
Item 2.
     21-30
16-23
 
Item 3.
  23
Item 4.
   3023 
Item 4.
  30
PART II.
    
Item 1.
  24
Item 1A.
24
Item 6.
24
   31
Item 1A.
 31
Item 6.
31
3225 
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 net earnings, sales, product demand, net revenues, operating margin, other guidance and 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 the 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 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 that 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 thereofof current U.S. health care legislation that might be 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 net revenues. The 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 its operations and result in material misstatements in its consolidated 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 the Company’s filings with the Securities and Exchange Commission, Part I, Item 1A Risk Factors of the 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 the Company’s forward-looking statements.

PART I. FINANCIAL INFORMATION
Item 1. Financial Statements
MERIDIAN BIOSCIENCE, INC. AND SUBSIDIARIES
Condensed Consolidated Statements of Operations (Unaudited)
(dollar and share amounts in thousands, except per share data)
   
Three Months Ended
  
Six Months Ended
 
   
March 31,
  
March 31,
 
   
2021
  
2020
  
2021
  
2020
 
NET REVENUES
  $85,264  $57,296  $178,181  $104,717 
COST OF SALES
   27,492   22,750   58,861   42,520 
                  
GROSS PROFIT
   57,772   34,546   119,320   62,197 
                  
OPERATING EXPENSES
                 
Research and development
   6,065   5,315   11,716   10,078 
Selling and marketing
   6,540   6,529   13,561   13,257 
General and administrative
   12,925   10,628   24,863   19,612 
Acquisition-related costs
      1,787      1,787 
Change in fair value of acquisition consideration
   (2,989  (2,491  (1,942  (1,304
Restructuring costs
   —     252     —   527 
Selected legal costs
   1,030   735   2,257   1,055 
                  
Total operating expenses
   23,571   22,755   50,455   45,012 
                  
OPERATING INCOME
   34,201   11,791   68,865   17,185 
                 
OTHER INCOME (EXPENSE)
                 
Interest income
   6   23   15   134 
Interest expense
   (472  (532  (1,006  (1,299
RADx grant income
   200   —     1,000   —   
Other, net
   (883  1,365   (1,574  653 
                  
Total other income (expense)
   (1,149  856   (1,565  (512
                  
EARNINGS BEFORE INCOME TAXES
   33,052   12,647   67,300   16,673 
                 
INCOME TAX PROVISION
   6,750   3,288   14,219   4,487 
                  
NET EARNINGS
  $26,302  $9,359  $53,081  $12,186 
                  
BASIC EARNINGS PER COMMON SHARE
  $0.61  $0.22  $1.23  $0.28 
DILUTED EARNINGS PER COMMON SHARE
  $0.60  $0.22  $1.21  $0.28 
WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING
BASIC
   43,244   42,830   43,171   42,810 
EFFECT OF DILUTIVE STOCK OPTIONS AND RESTRICTED SHARE UNITS
   878   138   789   143 
                  
WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING
DILUTED
   44,122   42,968   43,960   42,953 
                  
ANTI-DILUTIVE SECURITIES:
                 
Common share options and restricted share units
   166   1,635   169   1,520 
                  
   
Three Months
Ended
December 31,
 
   
2021
  
2020
 
NET REVENUES
  $88,341  $92,917 
COST OF SALES
   39,182   31,369 
   
 
 
  
 
 
 
GROSS PROFIT
   49,159   61,548 
   
 
 
  
 
 
 
OPERATING EXPENSES
         
Research and development
   6,194   5,651 
Selling and marketing
   7,741   7,021 
General and administrative
   14,660   11,938 
Selected legal costs
   281   1,227 
Change in fair value of acquisition consideration
   0     1,047 
   
 
 
  
 
 
 
Total operating expenses
   28,876   26,884 
   
 
 
  
 
 
 
OPERATING INCOME
   20,283   34,664 
   
OTHER INCOME (EXPENSE)
         
Interest income
   1   9 
Interest expense
   (372  (534
RADx grant income
   0     800 
Other, net
   (161  (691
   
 
 
  
 
 
 
Total other expense, net
   (532  (416
   
 
 
  
 
 
 
EARNINGS BEFORE INCOME TAXES
   19,751   34,248 
   
INCOME TAX PROVISION
   4,411   7,469 
   
 
 
  
 
 
 
NET EARNINGS
  $15,340  $26,779 
   
 
 
  
 
 
 
BASIC EARNINGS PER COMMON SHARE
  $0.35  $0.62 
DILUTED EARNINGS PER COMMON SHARE
  $0.35  $0.61 
WEIGHTED AVERAGE NUMBER OF COMMON 
SHARES OUTSTANDING - BASIC
   43,439   43,098 
EFFECT OF DILUTIVE STOCK OPTIONS AND 
RESTRICTED SHARE UNITS
   589   681 
   
 
 
  
 
 
 
WEIGHTED AVERAGE NUMBER OF COMMON 
SHARES OUTSTANDING - DILUTED
   44,028   43,779 
   
 
 
  
 
 
 
ANTI-DILUTIVE SECURITIES:
         
Common share options and restricted share units
   425   258 
   
 
 
  
 
 
 
The accompanying notes are an integral part of these condensed consolidated financial statements.
 
Page
1

Table of Contents
MERIDIAN BIOSCIENCE, INC. AND SUBSIDIARIES
Condensed Consolidated Statements of Comprehensive Income (Unaudited)
(dollar amounts in thousands)
   
Three Months
 
Ended
  
Six Months Ended
 
   
March 31,
  
March 31,
 
   
2021
  
2020
  
2021
  
2020
 
NET EARNINGS
  $26,302  $9,359  $53,081  $12,186 
Other comprehensive income (loss):
                 
Foreign currency translation adjustment
   79   (2,786  3,380   (18
Unrealized gain (loss) on cash flow hedge   439   (313  460   (313
Reclassification of amortization of gain on cash flow hedge
   (77  (77  (154  (154
Income taxes related to items of other comprehensive income (loss)   (80  96   (66  115 
                  
Other comprehensive income (loss), net of tax
   361   (3,080  3,620   (370
                  
COMPREHENSIVE INCOM
E
  $26,663  $6,279  $56,701  $11,816 
                  
   
Three Months Ended
December 31,
 
   
2021
  
2020
 
NET EARNINGS
  $15,340  $26,779 
Other comprehensive
(loss) income:
         
Foreign currency translation adjustment
   (58  3,301 
Unrealized gain on cash flow hedge
   550   21 
Reclassification of amortization of gain on cash flow hedge
   0     (77
Income taxes related to items of other
comprehensive (loss) income
   (135  14 
   
 
 
  
 
 
 
Other comprehensive income, net of tax
   357   3,259 
   
 
 
  
 
 
 
COMPREHENSIVE INCOME
  $15,697  $30,038 
   
 
 
  
 
 
 
The accompanying notes are an integral part of these condensed consolidated financial statements.
 
Page
2

MERIDIAN BIOSCIENCE, INC. AND SUBSIDIARIES
Condensed Consolidated Statements of Cash Flows (Unaudited)
(dollar amounts in thousands)
   
Six Months Ended March 31,
  
2021
  
2020
 
CASH FLOWS FROM OPERATING ACTIVITIES
         
Net earnings
  $53,081  $12,186 
Non-cash
items included in net earnings:
         
Depreciation of property, plant and equipment
   3,072   2,439 
Amortization of intangible assets
   4,363   3,449 
Stock compensation expense   2,291   1,759 
Deferred income taxes
   (777  656 
Change in fair value of acquisition consideration   (1,942  (1,304
Change in the following:
         
Accounts receivable
   (5,267  (4,950
Inventories
   (12,185  (2,511
Prepaid expenses and other current assets
   1,440   1,278 
Accounts payable and accrued expenses
   77   1,621 
Income taxes payable
   (2,698  400 
Other, net
   36   692 
          
Net cash provided by operating activities   41,491   15,715 
          
CASH FLOWS FROM INVESTING ACTIVITIES
         
Purchase of property, plant and equipment
   (11,955  (1,543
Payment of acquisition consideration holdback
   (5,000  —   
          
Net cash used in investing activities   (16,955  (1,543
          
CASH FLOWS FROM FINANCING ACTIVITIES
         
Payment on revolving credit facility
   (18,824  (27,000
Payment of debt issuance costs
   —     (116
Proceeds from exercise of stock options
   2,852   —   
          
Net cash used in financing activities   (15,972  (27,116
          
Effect of Exchange Rate Changes on Cash and Cash Equivalents
   1,296   97 
          
Net Increase (Decrease) in Cash and Cash Equivalents
   9,860   (12,847
Cash and Cash Equivalents at Beginning of Period
   53,514   62,397 
          
Cash and Cash Equivalents at End of Period
  $63,374  $49,550 
          
   
Three Months Ended
December 31,
 
   
2021
  
2020
 
CASH FLOWS FROM OPERATING ACTIVITIES
   
Net earnings
  $ 15,340  $ 26,779 
Non-cash
items included in net earnings:
         
Depreciation of property, plant and equipment
   1,700   1,508 
Amortization of intangible assets
   2,483   2,221 
Stock-based compensation
   1,903   1,241 
Deferred income taxes
   927   (852
Change in fair value of acquisition consideration
   0     1,047 
Change in the following:
         
Accounts receivable
   9,424   (1,776
Inventories
   2,093   (5,941
Prepaid expenses and other current assets
   200   2,682 
Accounts payable and accrued expenses
   1,018   (5,826
Income taxes payable
   1,113   4,032 
Other, net
   (646  6 
   
 
 
  
 
 
 
Net cash provided by operating activities
   35,555   25,121 
   
 
 
  
 
 
 
CASH FLOWS FROM INVESTING ACTIVITIES
         
Purchase of property, plant and equipment
   (1,708  (2,086
Payment of acquisition consideration holdback
   0     (5,000
   
 
 
  
 
 
 
Net cash used
in
investing activities
   (1,708  (7,086
   
 
 
  
 
 
 
CASH FLOWS FROM FINANCING ACTIVITIES
         
Payment on revolving credit facility
   (10,000  (10,000
Payment of
deferred financing costs
   (404  0   
Proceeds from exercise of stock options
   80   

 
Employee taxes 
paid upon net share settlement of restricted share units
   (763  0   
   
 
 
  
 
 
 
Net cash used
in
financing activities
   (11,087  (10,000
   
 
 
  
 
 
 
Effect of Exchange Rate Changes on Cash and Cash Equivalents
   198   1,644 
   
 
 
  
 
 
 
Net Increase in Cash and Cash Equivalents
   22,958   9,679 
Cash and Cash Equivalents at Beginning of Period
   49,771   53,514 
   
 
 
  
 
 
 
Cash and Cash Equivalents at End of Period
  $72,729  $63,193 
   
 
 
  
 
 
 
The accompanying notes are an integral part of these condensed consolidated financial statements.
 
Page
3

MERIDIAN BIOSCIENCE, INC. AND SUBSIDIARIES
Condensed Consolidated Balance Sheets
(dollar amounts in thousands)
ASSETS
 
  
March 31,
     
2021
   
September 30,
 
(Unaudited)
   
    
2020
    
   
December 31,
2021

(Unaudited)
   
September 30,
2021
 
CURRENT ASSETS
            
Cash and cash equivalents  $63,374   $53,514   $72,729   $49,771 
Accounts receivable, less allowances of $505 and $513, respectively
   44,895    38,512 
Accounts receivable, less allowances of $1,293 and $1,078,
respectively
   44,300    53,568 
Inventories, net
   72,534    61,264    74,198    76,842 
Prepaid expenses and other current assets
   7,491    8,900    12,426    12,626 
          
 
   
 
 
Total current assets
   188,294    162,190    203,653    192,807 
          
 
   
 
 
PROPERTY, PLANT AND EQUIPMENT, at Cost
            
Land
   991    991    987    989 
Buildings and improvements
   32,326    32,188    33,009    32,765 
Machinery, equipment and furniture
   74,173    69,854    79,438    78,410 
Construction in progress
   10,779    1,200    10,352    9,991 
          
 
   
 
 
Subtotal
   118,269    104,233    123,786    122,155 
Less: accumulated depreciation and amortization
   76,303    73,113    80,500    78,941 
          
 
   
 
 
Property, plant and equipment, net
   41,966    31,120    43,286    43,214 
          
 
   
 
 
OTHER ASSETS
            
Goodwill
   115,296    114,186    114,713    114,668 
Other intangible assets, net
   78,834    83,197    81,658    84,151 
Right-of-use
assets, net
   6,297    6,336    5,431    5,786 
Deferred income taxes
   8,017    7,647    8,813    8,731 
Other assets
   465    585    1,086    365 
          
 
   
 
 
Total other assets
   208,909    211,951    211,701    213,701 
          
 
   
 
 
TOTAL ASSETS
  $439,169   $405,261   $458,640   $449,722 
          
 
   
 
 
The accompanying notes are an integral part of these condensed consolidated financial statements.
 
Page
4

MERIDIAN BIOSCIENCE, INC. AND SUBSIDIARIES
 
Condensed Consolidated Balance Sheets
 
(dollar amounts in thousands)
 
 
LIABILITIES AND SHAREHOLDERS’ EQUITY
 
   
   
March 31,
   
September 30,
 
   
2021
   
2020
 
   
(Unaudited)
   
        
 
CURRENT LIABILITIES
          
Accounts payable
  $16,714   $11,969 
Accrued employee compensation costs
   12,634    16,661 
Current portion of acquisition consideration
   11,296    12,619 
Current operating lease obligations
   1,892    1,789 
Current government grant obligations
   608    600 
Other accrued expenses
   5,664    5,362 
Income taxes payable
   1,502    3,524 
           
Total current liabilities
   50,310    52,524 
           
NON-CURRENT
LIABILITIES
          
Acquisition consideration
   7,671    13,290 
Post-employment benefits
   2,429    2,493 
Fair value of interest rate swaps
   254    713 
Long-term operating lease obligations
   4,555    4,678 
Long-term debt
   50,000    68,824 
Government grant obligations
   10,537    10,524 
Long-term income taxes payable
   374    549 
Deferred income taxes
   3,389    3,804 
Other
non-current
liabilities
   177    233 
           
Total
non-current
liabilities
   79,386    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, 43,329,294 and 43,068,842
shares issued, respectively
   0—      0—   
Additional
paid-in
capital
   145,338    140,195 
Retained earnings
   162,375    109,294 
Accumulated other comprehensive income (loss)
   1,760    (1,860
           
Total shareholders’ equity
   309,473    247,629 
           
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY
  $439,169   $405,261 
           
MERIDIAN BIOSCIENCE, INC. AND SUBSIDIARIES
Condensed Consolidated Balance Sheets
(dollar amounts in thousands)
LIABILITIES AND SHAREHOLDERS’ EQUITY
   
December 31,
2021

(Unaudited)
   
September 30,
2021
 
CURRENT LIABILITIES
          
Accounts payable
  $16,293   $11,701 
Accrued employee compensation costs
   12,029    16,853 
Accrued product recall costs
   4,269    5,100 
Acquisition consideration
   1,000    0   
Current operating lease obligations
   2,057    1,990 
Current government grant obligations
   765    638 
Other accrued expenses
   8,667    7,027 
Income taxes payable
   4,866    3,848 
   
 
 
   
 
 
 
Total current liabilities
   49,946    47,157 
   
 
 
   
 
 
 
NON-CURRENT
LIABILITIES
          
Acquisition consideration
   0      1,000 
Post-employment benefits
   2,169    2,253 
Long-term operating lease obligations
   3,529    3,932 
Long-term debt
   50,000    60,000 
Government grant obligations
   5,068    5,176 
Long-term income taxes payable
   469    469 
Deferred income taxes
   2,067    1,055 
Other
non-current
liabilities
   173    378 
   
 
 
   
 
 
 
Total
non-current
liabilities
   63,475    74,263 
   
 
 
   
 
 
 
COMMITMENTS AND CONTINGENCIES
        
   
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, 43,514,258 and 43,361,898 shares
issued and outstanding, respectively
   0—      0—   
Additional
paid-in
capital
   148,623    147,403 
Retained earnings
   196,041    180,701 
Accumulated other comprehensive income
   555    198 
   
 
 
   
 
 
 
Total shareholders’ equity
   345,219    328,302 
   
 
 
   
 
 
 
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY
  $458,640   $449,722 
   
 
 
   
 
 
 
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)
      
   Common
Shares
Issued
   Additional
Paid-In

Capital
  Retained
Earnings
   Accumulated
Other
Comprehensive
Income (Loss)
  Total
Shareholders’
Equity
 
THREE MONTHS ENDED MARCH 31, 2021
                       
Balance at December 31, 2020
   43,124   $141,395  $136,073   $1,399  $278,867 
Conversion of restricted share units and exercise of stock options
   205    2,893   —      —     2,893 
Stock compensation expense
   —      1,050   —      —     1,050 
Net earnings
   —      —     26,302    —     26,302 
Foreign currency translation adjustment
   —      —     —      79   79 
Hedging activity, net of tax
   —      —     —      282   282 
                        
Balance at March 31, 2021
   43,329   $145,338  $162,375   $1,760  $309,473 
                        
THREE MONTHS ENDED MARCH 31, 2020
                       
Balance at December 31, 2019
   42,828   $133,622  $65,935   $(2,265 $197,292 
Conversion of restricted share units and exercise of stock options
   3    (9  —      —     (9
Stock compensation expense
   —      971   —      —     971 
Net earnings
   —      —     9,359    —     9,359 
Foreign currency translation adjustment
   —      —     —      (2,786  (2,786
Hedging activity, net of tax
   —      —     —      (294  (294
                        
Balance at March 31, 2020
   42,831   $134,584  $75,294   $(5,345 $204,533 
                        
 
  Common
Shares
Issued
   Additional
Paid-In

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

Capital
 Retained
Earnings
   Accumulated Other
Comprehensive
Income (Loss)
 Total
Shareholders’
Equity
 
SIX MONTHS ENDED MARCH 31, 2021
             
Balance at September 30, 2021
   43,362   $147,403  $180,701   $198  $328,302 
Conversion of restricted share units and exercise
of stock options
   152    (683  —      —     (683
Stock compensation expense
   —      1,903   —      —     1,903 
Net earnings
   —      —     15,340    —     15,340 
Foreign currency translation adjustment
   —      —     —      (58  (58
Hedging activity, net of tax
   —      —     —      415   415 
  
 
   
 
  
 
   
 
  
 
 
Balance at December 31, 2021
   43,514   $148,623  $196,041   $555  $345,219 
               
Balance at September 30, 2020
   43,069   $140,195  $109,294   $(1,860 $247,629    43,069   $140,195  $109,294   $(1,860 $247,629 
Conversion of restricted share units and exercise of stock options   260    2,852   —      —     2,852    55    (41  —      —     (41
Stock compensation expense
   —      2,291   —      —     2,291    —      1,241   —      —     1,241 
Net earnings
   —      —     53,081    —     53,081    —      —     26,779    —     26,779 
Foreign currency translation adjustment
   —      —     —      3,380   3,380    —      —     —      3,301   3,301 
Hedging activity, net of tax
   —      —     —      240   240    —      —     —      (42  (42
                    
 
   
 
  
 
   
 
  
 
 
Balance at March 31, 2021
   43,329   $145,338  $162,375   $1,760  $309,473 
Balance at December 31, 2020
   43,124   $141,395  $136,073   $1,399  $278,867 
                    
 
   
 
  
 
   
 
  
 
 
SIX MONTHS ENDED MARCH 31, 2020
             
Balance at September 30, 2019
   42,712   $132,834  $63,108   $(4,975 $190,967 
Conversion of restricted share units and exercise of stock options
   119    (9  —      —     (9
Stock compensation expense
   —      1,759   —      —     1,759 
Net earnings
   —      —     12,186    —     12,186 
Foreign currency translation adjustment
   —      —     —      (18  (18
Hedging activity, net of tax
   —      —     —      (352  (352
                  
Balance at March 31, 2020
   42,831   $134,584  $75,294   $(5,345 $204,533 
                  
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, immunoassay blocking reagents, various Polymerase Chain Reaction (“PCR”) master mixes, 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);Massachusetts; 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
in vitro medical device manufacturing, microRNA detection, next-generation sequencing, plant genotyping, and mutation detection, among others).
 
2.
Basis of Presentation
The Condensed Consolidated Financial Statements are unaudited and are prepared in accordance with United States (“U.S.”) generally accepted accounting principles (“GAAP”) for interim financial information, and the rules and regulations of the Securities and Exchange Commission (“SEC”). Certain information and footnote disclosures normally included in financial statements prepared in accordance with GAAP have been condensed or omitted pursuant to such rules and regulations. In the opinion of Management, the Condensed Consolidated Financial Statements include all normal adjustments and disclosures necessary to present fairly the Company’s consolidated financial position as of MarchDecember 31, 2021, and the results of its operations, cash flows, and shareholders’ equity for the three- and
six-month
periodsthree months ended MarchDecember 31, 2021 and 2020. These Condensed Consolidated Financial Statements should be read in conjunction with the audited consolidated financial statements and footnotes thereto included in the Company’s fiscal 20202021 Annual Report on Form
10-K,
filed with the SEC on November 23, 2020.2021.
It should be noted that the terms revenue and/or revenues are utilized throughout these notes to the Condensed Consolidated Financial Statements to indicate net revenue and/or net revenues.
The consolidated 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 April 2021, the U.S. Department of Health and Human Services extended the public health emergency declaration for
COVID-19.
During the past year, 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.
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Table of Contents
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 over the last year has focused primarily on
COVID-19
and critical care ailments. For the second half of our fiscal 2021, we expect demand for our Life Science segment’s reagent products used in
COVID-19
tests will be lower than that experienced during the six months ended March 31, 2021, as health care systems transition to more asymptomatic testing versus the predominant symptomatic testing we have seen over the last year. However, this varies by country based on their individual
COVID-19
case statistics. 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 these 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 Statement
s
Statements and the reported amounts of revenues and expenses during the period. Included within these estimates are those related to the ongoing impacts of the
COVID-19
pandemic, which has had both positive and negative effects on our business; positive effects on our Life Science segment and negative effects on our Diagnostics segment. Actual results could differ from those estimates.
the estimates made by management.
 
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Table of Contents
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 20202021 Annual Report on Form
10-K,
filed with the SEC on November 23, 20202021, and should be referred to for a description of the Company’s significant accounting policies.
(a)
(a) Recent Accounting Pronouncements –
Pronouncements Adopted
On October 1, 2020,2021, the Company adopted Financial Accounting Standards Board (“FASB”) Accounting Standards Update (“ASU”)
2016-13,2019-12,
Measurement of Credit LossesIncome Taxes (Topic 740): Simplifying the Accounting for Income Taxes
(“ASU
on Financial Instruments2019-12”),
, which changedclarified and simplified accounting for income taxes by eliminating certain exceptions for intraperiod tax allocation principles, the impairment model used to measure credit lossesmethodology for most financial assets. Use of the new forward-looking expected credit loss model for our accounts receivable valuation, rather than the previously utilized incurred credit loss model, resultedcalculating income tax rates in an immaterialinterim period, and recognition of deferred taxes for outside basis differences in an investment, among other updates. Adoption of ASU
2019-12
did not have a material impact on the Condensed Consolidated Financial Statements.
Pronouncements Issued but Not Yet Adopted as of MarchDecember 31, 2021
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.London Interbank Offered Rate (“LIBOR”). The guidance provides practical expedients and exceptions for applying GAAP to contracts, hedging relationships and other transactions affected by reference rate reform if certain criteria are met, which may be applied through December 31, 2022. The Company 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.
In December 2019, the FASB
No other new accounting pronouncements recently adopted or issued ASU
2019-12,
Income 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 applicationhad or are expected to have a material impact on the Condensed Consolidated Financial Statements.
 
(b)
Reclassifications –
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.
 
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Table of Contents
4.
Revenue Recognition
Overview
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.
Revenue Disaggregation
The following tables present our net revenues disaggregated by major geographic region, major product platform and disease state (Diagnostics segment only):
Revenue
Net Revenues by Reportable Segment & Geographic Region
   
Three Months Ended March 31,
  
Six Months Ended March 31,
 
   
2021
   
2020
   
Inc (Dec)
  
2021
   
2020
   
Inc (Dec)
 
Diagnostics-
                             
Americas
  $25,290   $27,670    (9)%  $48,824   $55,405    (12)% 
EMEA
   6,071    6,777    (10)%   12,101    13,277    (9)% 
ROW
   588    495    19  1,345    1,051    28
                              
Total Diagnostics
   31,949    34,942    (9)%   62,270    69,733    (11)% 
                              
Life Science-
                             
Americas
   13,550    4,612    194  32,296    8,623    275
EMEA
   21,773    9,946    119  54,066    14,907    263
ROW
   17,992    7,796    131  29,549    11,454    158
                              
Total Life Science
   53,315    22,354    139  115,911    34,984    231
                              
Consolidated  $85,264   $57,296    49 $178,181   $104,717    70
                              
Revenue by Product Platform/Type
 
  
Three Months Ended March 31,
 
Six Months Ended March 31,
   
Three Months Ended December 31,
 
  
2021
   
2020
   
Inc (Dec)
 
2021
   
2020
   
Inc (Dec)
   
2021
   
2020
   
Inc (Dec)
 
Diagnostics-
                            
Molecular assays
  $4,395   $7,238    (39)%  $8,985   $14,077    (36)% 
Non-molecular
assays
   27,554    27,704    (1)%   53,285    55,656    (4)% 
Americas
  $26,613   $23,551    13
EMEA
   6,093    6,020    1
ROW
   498    750    (34)%
                          
 
   
 
   
 
 
Total Diagnostics
  $31,949   $34,942    (9)%  $62,270   $69,733    (11)%    33,204    30,321    10
                        
Life Science-
                            
Molecular reagents
  $37,752   $11,534    227 $83,776   $16,902    396
Immunological reagents
   15,563    10,820    44  32,135    18,082    78
Americas
   8,137    18,755    (57)% 
EMEA
   28,648    32,311    (11)% 
ROW
   18,352    11,530    59
                          
 
   
 
   
 
 
Total Life Science
  $53,315   $22,354    139 $115,911   $34,984    231   55,137    62,596    (12)% 
                          
 
   
 
   
 
 
Consolidated
  $88,341   $92,917    (5)% 
  
 
   
 
   
 
 
 
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Table of Contents
Revenue
Net Revenues by Product Platform/Type
   
Three Months Ended December 31,
 
   
2021
   
2020
   
Inc (Dec)
 
Diagnostics-
               
Molecular assays
  $4,752   $4,590    4
Non-molecular
assays
   28,452    25,731    11
   
 
 
   
 
 
   
 
 
 
Total Diagnostics
  $33,204   $30,321    10
   
 
 
   
 
 
   
 
 
 
Life Science-
               
Molecular reagents
  $31,488   $46,029    (32)% 
Immunological reagents
   23,649    16,567    43
   
 
 
   
 
 
   
 
 
 
Total Life Science  $55,137   $62,596    (12)% 
   
 
 
   
 
 
   
 
 
 
Net Revenues by Disease State (Diagnostics segment only)
 
   
Three Months Ended March 31,
  
Six Months Ended March 31,
 
   
2021
   
2020
   
Inc (Dec)
  
2021
   
2020
   
Inc (Dec)
 
Diagnostics-
                             
Gastrointestinal assays
  $ 15,666   $ 14,014    12 $ 31,118   $ 30,060    4
Respiratory illness assays
   3,686    10,863    (66)%   8,492    18,612    (54)% 
Blood chemistry assays
   4,358    4,194    4  8,753    9,142    (4)% 
Other
   8,239    5,871    40  13,907    11,919    17
                              
Total Diagnostics  $31,949   $34,942    (9)%  $62,270   $69,733    (11)% 
                              
   
Three Months Ended December 31,
 
   
2021
   
2020
   
Inc (Dec)
 
Diagnostics-
               
Gastrointestinal assays
  $21,619   $15,452    40
Respiratory illness assays
   6,380    4,806    33
Blood chemistry assays
   78    4,394    (98)% 
Other
   5,127    5,669    (10)% 
   
 
 
   
 
 
   
 
 
 
Total Diagnostics
  $33,204   $30,321    10
   
 
 
   
 
 
   
 
 
 
Royalty Income
Royalty income received from DiaSorin, which primarilya third party related to sales of
H. pylori
products, totaled approximately $2,845$1,040 and $1,280 $860
in the three months ended March 31, 2021 and 2020, respectively, and $3,705 and $2,205 in the six months ended MarchDecember 31, 2021 and 2020, respectively. Such revenue is included as part of
Non-molecular
assays and Other within the RevenueNet Revenues by Product Platform/Type and RevenueNet Revenues by Disease State tables, respectively, above.
Reagent Rental Arrangements
Revenue allocated to the lease elements of Reagent Rental arrangements totaled approximately $900 $
995
and $1,125 $
880
in the
three
months ended March December 
31
,
2021
and
2020 respectively, and $1,780 and 2,250 in the six months ended March 31, 2021 and 2020,
, respectively.
Such revenue is included as part of net revenues in our Condensed Consolidated Statements of Operations.
 
5.
Fair Value Measurements
Certain asset
s
 and liabilities are recorded at fair value in accordance with Accounting Standards Codification (“ASC”) 820,
Fair Value Measurements and Disclosures
(“ASC 820”). ASC 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 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
Level 3
Prices or valuations that require inputs that are both significant to the fair value measurement and unobservable
T
oTo limit exposure to volatility in the LIBOR interest rate, the Company has 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 1112 to a fixed rate.
The fair values of the interest rate swap agreements were determined by reference to a third-party valuation, andwhich is considered a Level 2 input within the fair value hierarchy of valuation techniques.
techniques, and totaled a
$347
 asset and a 
$203
 
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Table of Contents
As describedindicated in Note 6, we acquired Exalenz Bioscience Ltd. (“Exalenz”) in fiscal 2020.the BreathTek business on July 31, 2021. The fair values of theinventories acquired accounts receivable, inventories, property, plant and equipment, and other current assets and the fair values of the assumed accounts payable and accrued expenses were valued using Level 2 inputs, which included data points that were observable, such as appraisals or established values of comparable assets and historical sales information (market approach). IntangibleIdentifiable intangible assets, specifically the acquired customer relationships, were valued using Level 3 inputs, which are unobservable by nature, and included internal estimates of future cash flows and attrition rates (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 subsequent amendments to modify 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
s
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
significantly 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:
       
Fair Value Measurements Using
Inputs Considered as
 
   
Carrying

Value
   
Level 1
   
Level 2
   
Level 3
 
Interest rate swaps -
               
As of March 31, 2021
  $(254)  $0     $(254)  $0   
As of September 30, 2020
  $(713)  $0     $(713)  $0   
Contingent consideration -               
As of March 31, 2021
  $(18,967)  $0     $0     $(18,967
As of September 30, 2020
  $(20,909)  $0     $0     $(20,909
6.
Business Combinations
On April 30, 2020 (“the acquisition date”), we acquired
100
% of the outstanding common shares and voting interest of Exalenz, a Modi’in, Israel based provider of the
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 repaid shortly after closing, the total consideration transferred was $
56,305
. To finance the acquisition, the Company utilized cash and cash equivalents on hand and proceeds drawn from our revolving credit facility (see Note 11). In anticipation of the transaction, we executed forward currency contracts to acquire the NIS required for the acquisition. As a result, the net cash outlay for the transaction prior to the repayment of debt was $
47,392
.
As a result of total consideration exceeding the preliminary fair value of the net assets acquired, goodwill in the amount of $24,827
was recorded in connection with this acquisition, none of which will be deductible for U.S. tax purposes. The goodwill results largely from our ability to market and sell the BreathID platform through our established customer base and distribution channels.
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The Company’s consolidated results for the three and six months ended March 31, 2021 include the following from Exalenz:
 
   
Three
Months Ended

March 31,
2021
   
Six
Months Ended

March 31,
2021
 
Net revenues
  $2,784   $5,882 
Net loss  $(947  $(1,739
           
These results for the three and six months ended March 31, 2021, which are reported as part of the Diagnostics segment, include $720 and
 $1,520
, respectively, of 
amortization expense related to specific identifiable assets recorded in the preliminary purchase price allocation, including a
non-compete
agreement, trade name, technology and customer relationships.
The recognized preliminary amounts of identifiable assets acquired and liabilities assumed in the acquisition of Exalenz are as follows:
Page
 
9
   
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    (296   4,033 
Other current assets
   851    1,825    2,676 
Property, plant and equipment
   544    (16   528 
Goodwill
   29,288    (4,461   24,827 
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    1,178    6,744 
                
    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 
                
Page 12

Table of Contents
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. 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.
Pro Forma Information
The following table provides the unaudited condensed consolidated pro forma results for the periods presented as if Exalenz had been acquired as of the beginning of fiscal 2020 (October 1, 2019). Pro forma results do not include the effect of any synergies achieved or 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 March 31,
   
Six Months
Ended March 31,
 
   
2021
   
2020
   
2021
   
2020
 
Net revenues
  $85,264   $60,701   $178,181   $111,895 
Net earnings
  $26,302   $8,064   $53,081   $9,246 
These unaudited pro forma amounts have been calculated by including the results of Exalenz and adjusting the results to give effect to the following, as if the acquisition had been consummated on October 1, 2019, together with the consequential tax effects thereon:
   
Three Months
Ended March 31,
   
Six Months Ended
March 31,
 
   
2021
   
2020
   
2021
   
2020
 
Adjustments to net revenues
                    
Exalenz pre-acquisition net revenues
  $0     $3,405   $0     $7,178 
                     
Adjustments to net earnings
                    
Exalenz pre-acquisition net loss
  $0     $(752  $0     $(1,504
Pro forma adjustments:
                    
Remove net impact of
non-continuing
personnel, locations or
activities
   0      490    0      591 
Incremental depreciation and amortization
   0      (911   0      (1,824
Incremental interest costs, net
   0      (381   0      (772
Tax effects of pro forma adjustments and recognizing benefit on
resulting Exalenz losses
   0      259    0      569 
                     
Total adjustments to net earnings  $0     $(1,295  $0     $(2,940
                     
Page 13

7.6.
Business Combinations
On July 31
, 2021 (“the BreathTek acquisition date”), we acquired the BreathTek business, a urea breath test for the detection of
H. pylori
, from Otsuka America Pharmaceutical, Inc. Cash consideration totaled $19,585, subject to a $1,000
 holdback, which is recorded in acquisition consideration on the Condensed Consolidated Balance Sheets, to secure the selling party’s performance of certain post-closing obligations that is payable 15 months following the BreathTek acquisition date. As part of the acquisition, we acquired BreathTek inventories and assumed the customer relationships to supply the BreathTek product in North America. The acquired inventories and customer relationships were valued on July 31, 2021 on a preliminary basis, at 
$9,855 and $9,730, respectively, with the useful life of the customer relationships estimated at five years
. There have been no material purchase price adjustments to the preliminary inventories and customer relationships values through December 31, 2021. The Company’s consolidated results for the three-month period ended December 31, 2021 include 
$5,611 of net revenues from sales of BreathTek products, which contributed approximately $1,600 of net earnings. These results, which are reported as part of the Diagnostics segment, include amortization expense related to the customer relationships recorded in the purchase price allocation totaling $486.
The following table provides the unaudited consolidated pro forma results for the periods presented as if the BreathTek business had been acquired as of the beginning of fiscal 2021:
Three Months Ended December 31,
  2021   2020 
Net revenues
  $88,341   $97,824 
Net earnings
   15,340    28,014 
7.
Lead Testing Matters
On September 1, 2021, the Company’s wholly owned subsidiary Magellan announced the expansion of a Class I voluntary recall of its LeadCare test kits for the detection of lead in blood, which it had initiated in May 2021. Customers generally run controls when they receive a new lot of product and reported to us that the control results were outside of specified ranges. As a result of the identified issue, impacted test kit lots could potentially underestimate blood lead levels when processing patient blood samples. Although it was initially believed that the root cause of the issue related to the plastic containers used for the treatment reagent, additional studies have indicated that the root cause relates to the third-party-sourced cardboard trays that hold the containers used for the treatment reagent. The Company continues to work closely with the FDA in its execution of the recall activities, which include notifications to customers and distributors, and providing instructions for the return of impacted test kits. The evaluation of the recall, the related notification process and correction of the identified supplier issue is ongoing. Of the approximate
$5,100
 estimated and accrued as of September 30, 2021 to cover the estimated costs of the recall, approximately 
$4,300
remains accrued and is reflected in the Condensed Consolidated Balance Sheet as of December 31, 2021. Anticipated recall-related costs, which primarily include product replacement and/or refund costs, mailing/shipping costs, attorneys’ fees, and other miscellaneous costs are estimated based upon the most recent information available. Information utilized in the accrual estimation process includes observable inputs such as customer
on-hand
inventory data, product sales data, average sales price, and product inventory turns, among other things. Available information is subject to change as the recall period extends, and such changes will be recorded in the period known. There have been no material changes in estimates related to the LeadCare recall reserve during the three months ended December 31, 2021.

As previously disclosed, o
n April 17, 2018
, the
Company’s wholly owned subsidiary Magellan received a subpoena from the U.S. Department of Justice (“DOJ”) regarding its LeadCare product line. The subpoena outlined 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 that have followed receipt of the subpoena in April 2018. The Company has executed tolling agreements to extend the statute of limitations. In March and April 2021, DOJ issued two subpoenas calling for witnesses to testify before a federal grand jury related to this matter. The March 2021 subpoena was issued to a former employee of Magellan, and the April 2021 subpoena was issued to a current employee of Magellan. In September and October 2021, DOJ issued additional subpoenas to individuals seeking testimony and documents in connection with its ongoing investigation. It is the Company’s understanding that multiple witnesses have testified before the federal grand jury and the DOJ’s activity before the federal grand jury is ongoing. The Company cannot predict when the investigation will be resolved, the outcome of the investigation, or its potential impact on the Company. Approximately
$281 and $1,227
of expense for attorneys’ fees related to this matter is included within the Condensed Consolidated Statements of Operations for the three months ended December 31, 2021 and 2020, respectively.
Page 1
0

8.
Cash and Cash Equivalents
Cash and cash equivalents include the following:
 
  
December 31,
2021
   
September 30,
2021
 
  
March 31,
2021
   
September 30,
2020
 
Institutional money market funds
  $1,017   $1,017   $1,020   $1,020 
Cash on hand, unrestricted
   62,357    52,497    71,709    48,751 
          
 
   
 
 
Total
  $63,374   $53,514   $72,729   $49,771 
          
 
   
 
 
Cash equivalents, institutional money market funds, are classified within Level 1 of the fair value hierarchy. Financial instruments classified as Level 1 are based on quoted market prices in active markets. The Company does not adjust the quoted market price for such financial instruments.
 
8.9.
Inventories, Net
Inventories, net, are comprised of the following:
 
  
December 31,
2021
   
September 30,
2021
 
  
March 31,
2021
   
September 30,
2020
 
Raw materials
  $18,706   $11,966   $15,104   $14,843 
Work-in-process
   22,987    19,477    21,479    25,072 
Finished goods - instruments
   1,933    1,594    2,699    2,260 
Finished goods - kits and reagents
   28,908    28,227    34,916    34,667 
          
 
   
 
 
Total
  $72,534   $61,264   $74,198   $76,842 
          
 
   
 
 
 
9.
10.
Goodwill and Other Intangible Assets, Net
Goodwill is not amortized but is subject to an annual impairment test. Goodwill has been assigned to reporting units within the reportable segments. The Company assesses the carrying value of goodwill annually, or more often if events or changes in circumstances indicate there may be impairment. Impairment testing is performed at a reporting unit level. During the three months ended December 31, 2021, goodwill increased
$45, reflecting: (i) a $4 increase from the currency translation adjustment on goodwill in the Diagnostics segment; and (ii) a $41 increase from the currency translation adjustment on goodwill in the Life Science segment.
During the three months ended December 31, 2021, the Company did not observe any triggering events or substantive changes in circumstances requiring the need for an interim impairment assessment.
A summary of other intangible assets, net, subject to amortization is as follows:
   
December 31, 2021
   
September 30, 2021
 
   
Gross
Carrying
Value
   
Accumulated
Amortization
   
Gross
Carrying
Value
   
Accumulated
Amortization
 
Manufacturing technologies, core products and cell lines
  $62,421   $23,592   $62,416   $22,633 
Trade names, licenses and patents
   18,495    9,806    18,489    9,492 
Customer lists, customer relationships and

supply agreements
   54,954    20,887    54,941    19,649 
Non-compete
agreements
   110    37    110    31 
   
 
 
   
 
 
   
 
 
   
 
 
 
Total
  $135,980   $54,322   $135,956   $51,805 
   
 
 
   
 
 
   
 
 
   
 
 
 
Page 11
The aggregate amortization expense for these other intangible assets was $2,483 and $2,221 for the three months ended December 31, 2021 and 2020
, respectively.
The estimated aggregate amortization expense for these other intangible assets for each of the fiscal years through fiscal 2027 is as follows: remainder of fiscal 2022 – $7,455, fiscal 2023 – $9,925, fiscal 2024 – $9,920, fiscal 2025 – $9,915, fiscal 2026 – $8,920, and fiscal 2027 – $6,645.

11.
Leasing Arrangements
The Company is party to a number ofseveral operating leases, the majority of which are related to office, warehouse and manufacturing space. The related operating lease assets and obligations are reflected within
right-of-use
assets, net, current operating lease obligations, and long-term operating lease obligations on the Condensed Consolidated Balance 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.
The lease costs for these operating leases reflected in
our Condensed Consolidated Statements of Operations, for the three and six months ended March 31, 2021 and 2020, as well as the
right-of-use
assets, net, obtained during these periods in exchange for operating lease liabilities, are as follows:
 
   
Three Months
Ended March 31,
   
Six Months
Ended March 31,
 
   
2021
   
2020
   
2021
   
2020
 
Lease costs within cost of sales
  $198   $130   $356   $259 
Lease costs within operating expenses
   387    292    761    559 
Right-of-use
assets, net obtained in exchange for operating lease liabilities
   612    222    692    222 
Three Months Ended December 31,
  
2021
   
2020
 
Lease costs within cost of sales
  $225   $158 
Lease costs within operating expenses
   388    374 
Right-of-use
assets, net
,
obtained in exchange for operating lease liabilities
   218    80 
In addition, the Company periodically enters into other short-term operating leases, generally with an initial term of twelve months or less. These leases are not recorded on the Condensed Consolidated Balance Sheets and the related lease expense is immaterial for the three and six months ended MarchDecember 31, 2021 and 2020.
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 discount rate implicit within our leases is generally not
Page 14

determin
a
ble determinable and, therefore, the Company uses its incremental borrowing rate as the basis for its discount rate.

The weighted average remaining lease term for our operating leases and the weighted average discount rate used to measure our operating leases as of March 31, 2021 and September 30, 2020 were as follows:
 
  
March 31,
2021
 
September 30,
2020
   
December 31,
2021
 
September 30,
2021
 
 
Weighted average remaining lease term
   3.8 years   4.2 years    3.3 years   3.6 years 
Average discount rate
   3.4  3.7%   3.2  3.2%
Maturities of lease liabilities by fiscal year for the Company’s operating leases
were
as follows as of MarchDecember 31, 2021:
    
2021 (represents remainder of fiscal year)
  $1,108 
2022
   2,016 
2023
   1,482 
2024
   1,108 
2025
   806 
Thereafter
   331 
      
Total lease payments
   6,851 
Less amount of lease payments representing interest
   (404
      
Total present value of lease payments
  $6,447 
      
2022 (represents remainder of fiscal year)
  $1,687 
2023
   1,690 
2024
   1,218 
2025
   908 
2026
   316 
Thereafter
   62 
   
 
 
 
Total lease payments
   5,881 
Less amount of lease payments representing interest
   (295
   
 
 
 
Total present value of lease payments
  $5,586 
   
 
 
 
Page 1
2

Supplemental cash flow information related to the Company’s operating leases are as follows:
      
Six Months Ended March 31,
  
2021
    
2020
 
Cash paid for amounts included in the measurement of lease liabilities:
           
Operating cash flows from operating leases
  $1,072    $778 
            
10.
Goodwill and Other Intangible Assets, Net
During the
six
months ended March 31, 2021, goodwill increased $1110, reflecting: (i) an additional $361 acquisition measurement period adjustment related to Exalenz (Diagnostics segment; see Note 6); (ii) a $67 increase from the currency translation adjustment on goodwill in the Diagnostics segment; and (iii) a $682 increase from the currency translation adjustment on goodwill in the Life Science segment.
Page 15

A summary of other intangible assets, net subject to amortization is as follows:
 
   
March 31, 2021
   
September 30, 2020
 
   
Gross
Carrying
Value
   
Accumulated
Amortization
   
Gross
Carrying
Value
   
Accumulated
Amortization
 
Manufacturing technologies, core products and cell lines
  $62,446   $20,756   $62,363   $18,750 
Trade names, licenses and patents
   18,524    8,813    18,425    7,801 
Customer lists, customer relationships and supply agreements
   45,287    17,944    45,071    16,210 
Government grants
   858    858    810    810 
Non-compete
agreements
   110    20    110    11 
                     
Total
  $127,225   $48,391   $126,779   $43,582 
                     
Three Months Ended December 31,
  
2021
   
2020
 
Cash paid for amounts included in the measurement of lease liabilities:
          
Operating cash flows from operating leases
  $627   $494 
   
 
 
   
 
 
 
The aggregate amortization expense for these other intangible assets was $2,142 and $1,727 for the three months ended March 31, 2021 and 2020, respectively
, and
 
$4,363
and
$3,449
for the six months ended March 31, 2021 and 2020, respectively. The estimated aggregate amortization expense for these other intangible assets for each of the fiscal years through fiscal 2026 is as follows: remainder of fiscal 2021 –
$4,210, fiscal 2022 – $8,000, fiscal 2023 – $7,975, fiscal 2024 – $7,975, fiscal 2025 – $7,950, and fiscal 2026 – $7,300.
11.
12.
Bank Cred
i
tCredit Arrangements
In anticipation of the acquisition of the business of GenePOC, on May 24, 2019
,
the Company entered into a credit facility agreement with a commercial bank.
The Company amended the credit facility agreement 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 Companymaintains a revolving credit facility in an aggregate principal amount notwith a commercial bank, which on October 25, 2021, was amended primarily to: (i) increase the borrowing capacity from $150,000 to exceed $160,000 (originally $125,000),$200,000; (ii) extend the term from May 24, 2024 to October 25, 2026; and (iii) modify the financial covenants to more closely align with outstandingthe Company’s size and strategic plans. Other provisions of the credit facility remain unchanged. Outstanding principal amounts bearingbear 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 2.60%2.22% and 4.15%2.54% on the revolving credit facility during the
three months
ended March 31, 2021 and 2020,
 respectively,
 and 
 2.57% and 4.04% during the six months ended MarchDecember 31, 2021 and 2020, respectively. Since entering into the revolving credit facility, three draws totaling $125,824 have been made on the credit facility, with principal repayments in January 2020, September 2020, December 2020 and February 2021 of $27,000, $30,000, $10,000 and $8,824, respectively, resulting in an outstanding principal balance of $50,000 and $68,824 at March 31, 2021 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 existing $60,000 five-year term loan; and (ii) along with cash
on-hand,
fund the Exalenz and GenePOC 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 MarchDecember 31, 2021 and September 30,
2020,
2021, approximates the current carrying value reflected in the Condensed Consolidated Balance Sheets.Sheets of $50,000 and $60,000, respectively, which is consistent with a level 2 fair value measurement.
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 MarchDecember 31, 2021, the Company was in compliance with all covenants.
 
Page 16

12.
13.
Contingent Obligations and
Non-Current
Liabilities
In connection with the acquisition of Exalenz (see Note 6),Bioscience Ltd. (“Exalenz”) in fiscal 2020, the Company assumed several Israeli government grant obligations. The repayment of the grants, along with interest incurred at varying stated fixed rates based on LIBOR at the time each grant was received, (ranging from 0.58% to 6.60%), is not dictated by an established repayment schedule. Rather, the grants and related interest are required to be repaid
using 3% of the net revenues 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 collateral or financial covenant provisions generally associated with traditional borrowing instruments. These
T
hese obligation amounts total $11,145$5,833 and $11,124$5,814 as of MarchDecember 31, 2021 and September 30, 2020,2021, respectively, andbearing interest at rates ranging from 0.58% to 2.02%.
The grant obligations are reflected in the Condensed Consolidated Balance Sheets as follows:
 
   
March 31,

2021
   
September 30,
2020
 
Current liabilities
  $608   $600 
Non-current
liabilities
  $10,537   $10,524 
   
December 31,
2021
   
September 30,
2021
 
Current liabilities
  $765   $638 
Non-current
liabilities
  $5,068   $5,176 
Additionally, the Company has provided certain post-employment benefits to its former Chief Executive Officer, and these obligations total $1,748$1,639 and $1,840$1,676 at MarchDecember 31, 2021 and September 30, 2020,2021, respectively. In addition, the Company is required by the governments of certain foreign countries in which we operate to maintain a level of accrual
s
accruals for potential future severance indemnity. These accruals total $853$707 and $814$754 at MarchDecember 31, 2021 and September 30, 2020,202
1
, respectively.
Page 1
3

 
13.
14.
National Institutes of Health Contracts
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. During the three and six months ended March 31,fiscal 2021, the Company
recorded
$200 and received $1,000 respectively, under the grant contract for reimbursement of elig
i
bleeligible research and development expenditures. These amounts areexpenditures, $800 of which was received during the three months ended December 31, 2020 and is included within other income (expense) in the Condensed Consolidated StatementsStatement of Operations.Operations for that period.
Effective February 1, 2021, the Company entered into a second grant contract under the RADx initiative, the purpose of which 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
As of December 31, 2021: (i)
$1,500 has been received related to this contract areand is reflected as a reduction in the cost of equipment within construction in progress on the Condensed Consolidated Financial Statements.
Balance Sheet; and (ii) the Company was in the process of finalizing an amendment to the grant, which among other things, would increase the grant by $
2,500
to a total of $
8,000
and extend the term by 12 months (see Note 17 for discussion of subsequent amendment to the grant).
14.
15.
Reportable Segment and Major Customers Information
During
The Company’s reportable segments maintain separate financial information for which results of operations are evaluated on a regular basis by the threeCompany’s chief operating decision maker in deciding how to allocate resources and six months ended March 31, 2021, products related to
COVID-19
accounted for approximately 58% and 64%,
 respectively, of Life Science segment revenues, and 37% and 41%, respectively, of consolidated revenues. In addition, during the three and six months ended March 31, 2021 and 2020, no individual Diagnostics or Life Science segment customer accounted for
10% or more of consolidated  revenues.
in assessing performance.
Page 17

Individual Diagnostics or Life Science segment customers,business operations to the reportable segments, including their affiliates, comprising 10% or moreallocations for certain corporate-wide costs such as treasury management, human resources and technology, among others. Corporate provides certain executive management and administrative services to each reportable segment. These services primarily include executive oversight by
non-segment-specific
executives, including the Board of Directors, along with certain other corporate-wide support functions such as insurance, legal and business development. The Company generally does not allocate these types of corporate expenses to the reportable segment revenues during any of the three- and
six-monthsegments.
periods ended March 31, 2
0
21 and 2020 were as follows:
  
   
Three Months
Ended March 31,
  
Six Months
Ended March 31,
 
   
 2021 
  
2020 
  
 2021 
  
2020 
 
Diagnostics
                 
Customer A
   10  9  11  11
Customer B
   10  13  10  14
Customer C
   11  5  11  5
                  
                  
Life Science
                 
Customer D
   9  13  6  11
Customer E
   9  5  14  4
                  
In addition, during both the three and six mo
n
ths ended March 31, 2021, the Life Science segment’s ten largest customers, including their affiliates, accounted for approximately 48% and 30% of Life Science segment revenues and consolidated revenues, respectively.
Two Life Science segment customers accounted for the following significant percentages of consolidated accounts receivable:
   
March 31,
2021
   
September 30,
2020
 
Customer D
  10  8
Customer E
  3  15
          
Page 18

Reportable segment and corporate information for the inte
r
iminterim periods is as follows:
 
   
Diagnostics
   
Life Science
   
Corporate
(1)
  
Eliminations
(2)
  
Total
 
Three Months Ended March 31, 2021
 
Net revenues -
                       
Third-party
  $31,949   $53,315   $—    $—    $85,264 
Inter-segment
   116    91    —     (207  —   
Operating income
   2,421    36,089    (4,325  16   34,201 
Goodwill (March 31, 2021)
   95,283    20,013    —     —     115,296 
Other intangible assets, net (March 31, 2021)
   78,832    2    —     —     78,834 
Total assets (March 31, 2021)
   313,271    125,947    —     (49  439,169 
                        
Three Months Ended March 31, 2020
     ��                 
Net revenues -
                       
Third-party
  $34,942   $22,354   $—    $—    $57,296 
Inter-segment
   81    55    —     (136  —   
Operating income
   4,729    9,931    (2,896  27   11,791 
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 
                        
Six Months Ended March 31, 2021
 
Net revenues -
                       
Third-party
  $62,270   $115,911   $—    $—    $178,181 
Inter-segment
   185    109    —     (294  —   
Operating income
   1,239    75,886    (8,288  28   68,865 
                        
Six Months Ended March 31, 2020
 
Net revenues -
                       
Third-party
  $69,733   $34,984   $—    $—    $104,717 
Inter-segment
   178    120    —     (298  —   
Operating income
   9,870    12,259    (4,983  39   17,185 
   
Diagnostics
  
Life Science
   
Corporate
(1)
  
Eliminations
(2)
  
Total
 
Three Months Ended December 31, 2021
 
Net revenues -
                      
Third-party
  $33,204  $55,137   $—    $—    $88,341 
Inter-segment
   34   55    —     (89  —   
Operating (loss) income
   (2,612  26,517    (3,637  15   20,283 
Goodwill (December 31, 2021)
   94,908   19,805    —     —     114,713 
Other intangible assets, net (December 31, 2021)
   81,656   2    —     —     81,658 
Total assets (December 31, 2021)
   352,318   106,339    —     (17  458,640 
   
 
 
  
 
 
   
 
 
  
 
 
  
 
 
 
Three Months Ended December 31, 2020
                      
Net revenues -
                      
Third-party
  $30,321  $62,596   $—    $—    $92,917 
Inter-segment
   69   18    —     (87  —   
Operating (loss) income
   (1,182  39,797    (3,963  12   34,664 
Goodwill (September 30, 2021)
   94,904   19,764    —     —     114,668 
Other intangible assets, net (September 30, 2021)
   84,149   2    —     —     84,151 
Total assets (September 30, 2021)
   339,208   110,536    —     (22  449,722 
   
 
 
  
 
 
   
 
 
  
 
 
  
 
 
 
 
(1) 
Includes selected legal costs of
$1,030$281 and $2,257
$1,227 in the three and six months ended MarchDecember 31, 2021 respectively, and restructuring costs and selected legal costs of
$685 and $1,055
in the three and six months ended March 31, 2020, respectively.
(2) 
Eliminations consist of inter-segment transactions.
 
Page 191
4

A reconciliation of reportable segment operating (loss) income to consolidated earnings before income taxes for the interim periodsthree months ended December 31, 2021 and 2020, is as follows:
 
  Three Months Ended   Six Months Ended 
  
March 31,
   
 March 31,
 
  
2021
   
2020
   
2021
   
2020
 
Operating income:            
Three Months Ended December 31,
  
2021
   
2020
 
Operating (loss) income:
      
Diagnostics segment
  $2,421   $4,729   $1,239   $9,870   $(2,612  $(1,182
Life Science segment
   36,089    9,931    75,886    12,259    26,517    39,797 
Eliminations
   16    27    28    39    15    12 
                  
 
   
 
 
Total operating income
   38,526    14,687    77,153    22,168    23,920    38,627 
Corporate operating expenses
   (4,325   (2,896   (8,288   (4,983
Corporate expenses
   (3,637   (3,963
Interest income
   6    23    15    134    1    9 
Interest expense
   (472   (532   (1,006   (1,299   (372   (534
RADx initiative grant income
   200    —      1,000    —      0      800 
Other, net
   (883   1,365    (1,574   653    (161   (691
                  
 
   
 
 
Consolidated earnings before income taxes
  $33,052   $12,647   $67,300   $16,673   $19,751   $34,248 
                  
 
   
 
 
Transactions betw
e
enbetween reportable segments are accounted for at established intercompany prices for internal and management purposes, with all intercompany amounts eliminated in consolidation
.
consolidation.
15.    
Income
Taxes
The effective rateNet revenues generated by the Company’s three major Diagnostics segment product families – gastrointestinal, respiratory illnesses and blood chemistry – accounted for inco
m
e taxes was 20%32% and 21%
for the three and six months ended March 31, 2021, respectively, and 
26% and 27%
 for the three and six months ended March 31, 2020. The lower fiscal 2021 effective tax rates result primarily from the combined effects of the following: (i) 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.”); (ii) the non-deductibility of a significant portion of the acquisition-related costs related to Exalenz; and (iii) the tax impact of restricted share unit lapses and stock option exercises occurring on dates when the share price of Company stock was significantly higher than the share price on the date such equity awards were granted. 
16.    
Litigation
Matters
On April 17, 2018,
Magellan r
e
ceived a subpoena from the U.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
$1,030 and $725
of expense for attorneys’ fees related to this matter is included within the Condensed Consolidated Statements of Operations forconsolidated net revenues during the three months ended March 31, 2021 and 2020, respectively, and approximately 
$2,257 and $1,005
for the six months ended MarchDecember 31, 2021 and 2020, respectively.
Three individual Diagnostics and two Life Science segment customers, including their affiliates,
comprising 10% or more of reportable segment net revenues were as follows: 
Three Months Ended December 31,
  
2021
  
2020
 
Diagnostics
         
Customer A
   10%  12%
Customer B
   11%  10%
Customer C
   11%  11%
         
Life Science
         
Customer D
   14%  19%
Customer E
   23%  2%
In addition, the two Life Science segment customers, including their affiliates, identified above accounted for greater than 10% of consolidated net revenues as follows:
Three Months Ended December 31,
  
2021
  
2020
 
Life Science
         
Customer D
   9%  13%
Customer E
   14%  2%
No
individual Diagnostics segment customer accounted for greater than 10% of consolidated net revenues during the three months ended December 31, 2021 or 2020.
During the three months ended December 31, 2021 and 2020, the Life Science segment’s ten largest customers, including their affiliates, accounted for approximately
 67% and 55%, respectively, of Life Science segment net revenues, and 42% and 37%, respectively, of consolidated net revenues.

 
Page 20
1
5

No Diagnostics or Life Science segment customer accounted for greater than 10% of consolidated accounts receivable as of December 31, 2021, while one Diagnostics segment customer (Customer B above) and one Life Science segment customer (Customer D above) accounted for approximately 12% and 10%, respectively, of consolidated accounts receivable as of September 30, 2021.
16.
Income Taxes
The effective rate for income taxes was approximately
 22%
for each of the three months ended December 31, 2021 and 2020.
17.
Subsequent Event
On January 25, 2022, the Company entered into an amended grant contract under the RADx initiative. The purpose of this grant is to support the Company’s manufacturing production
scale-up
and expansion to meet the demand for
COVID-19
testing, as well as the Company’s Revogene respiratory assay. The amended contract is a twelve-month service contract through January 2023, with payment of up to an additional $2,500 being made based on the Company achieving key milestones related to increasing its capacity to produce
COVID-19
tests and the Revogene respiratory assay, bringing the total possible payment under the grant to $8,000.
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 the financial condition, changes in financial condition and results of operations of Meridian Bioscience, Inc. (“Meridian”, the “Company”, “We”). This discussion should be read in conjunction with the Condensed 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 (“MD&A”) to indicate net revenue and/or net revenues. In addition, throughout the MD&A, we refer to certain product tradenames and trademarks, which are protected under applicable intellectual property laws and are our property. Solely for convenience, these tradenames and trademarks are referred to without the
®
or
symbols, but such references are not intended to indicate in any way that we will not assert, to the fullest extent of the law, our rights to these tradenames and trademarks.trademar
ks.
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).Massachusetts. 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, immunoassay blocking reagents, various Polymerase Chain Reaction (“PCR”) master mixes, 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 16

Recent Developments
Impact of
COVID-19
Pandemic
In December 2019, the
SARS-CoV-2
virus emergedStarting in Wuhan, Chinathe latter half of fiscal 2020 and spreadcontinuing 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 April 2021, the United States (“U.S.”) Department of Health and Human Services extended the public health emergency declaration for
COVID-19.
During the past year, 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.
Thefiling, the
COVID-19
pandemic has had both positive and negative effects on our businesses. business.
Our Life Science segment’s products werehave been well positioned to respond to
in-vitro
in vitro device (“IVD”) manufacturers’ needsincreased demand for reagents forused in the manufacture of molecular, rapid antigen and serology tests. Consequently, our Life Science segment grew itshas consistently delivered significantly higher levels of net revenues over 100%and operating income than those achieved prior to the COVID-19 pandemic, with the to date peak in such levels occurring during the third quarter of fiscal 2020 and delivered record operating income and margin, demonstrating what this segment could achieve at a much larger scale. This higher-than-historical level of growth continued into the first halfquarter of fiscal 2021, for the Life Science segment, with revenue for the three and six months ended March 31, 2021 exceeding the comparable fiscal 2020 periods by approximately 140% and 230%, respectively.
Our Diagnostics segment, on the other hand, reported decreased year-over-year revenues in the both the first and second quarters of fiscal 2021, a continuation of the trends experienced in the third and fourth quarters of fiscal 2020, ashas generally been negatively impacted by health systemssystems’ increased focus on
SARS-CoV-2
COVID-19
testing over traditional infectious disease and blood-chemistry testing. Following signsThe impacts of the
COVID-19
pandemic are most dramatically evident in the 34% year-over-year decline in revenues from respiratory illness assays in fiscal 2021, following flat year-over-year revenue levels experienced in fiscal 2020. Reflecting what we believe to be the start of a recovery in our Diagnostics segment late in fiscal 2020, as evidenced by a 38% sequential quarter increase inreturn to
pre-pandemic
activity levels, during the fourthfirst quarter of fiscal 2020, and which continued throughout the early part of2022, revenues from respiratory illness assays were 33% higher than the first quarter of fiscal 2021 the recent volatility in
COVID-19
infection rates has resulted in sequential quarter growth in Diagnostic segment revenues of only 2% and 5% in18% lower than the
pre-pandemic
first and second quartersquarter of fiscal 2021, respectively.2020, a marked improvement over the aforementioned 34% decline in fiscal 2021.
Despite these recent
COVID-19
pandemic related trends, due to the many uncertainties surrounding the
COVID-19
Page 21

Tablepandemic, we can provide no assurances with respect to our views of Contentsthe longevity or severity of the positive or negative impacts to our consolidated financial condition of the ongoing
COVID-19
pandemic.
Employee Safety
WeWhile our employee base in the U.S. has returned to working
on-site
at our facilities, we have implemented a hybrid work-from-home processes on a
site-by-site
basisprogram for employees whose
on-site
presence is designated as
non-essential
to the ongoing functions of our manufacturing sites, distribution centers,certain personnel, and new product development facilities. Wewe continue to utilize thisa work-from-home process as needed on a
site-by-site
basis. basis outside the U.S. for those employees whose
on-site
presence has been deemed to be
non-essential.
We also implementedcontinue to utilize enhanced cleaning and sanitizing procedures and providedprovide additional personal hygiene supplies at all our sites. We have 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 encouraged to 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 continuehave continued to operate with little, if any, impact on shipments to customers to date. As the
COVID-19
pandemic continues, 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 remainhave generally remained intact, providing access to sufficient inventory of the key materials needed for manufacturing. To date,While we have experienced extended lead times for certain select raw materials, delays and allocations for certain raw materials of higher demand have to date been limited and have not had a material impact on our results of operations. We regularly communicate withFrom time to time, we identify alternative suppliers third-party partners, customers, health care providers and government officialsto address the risk of a current supplier’s inability to deliver materials in ordervolumes sufficient to respond rapidlymeet our manufacturing needs; or we may choose to issues as they arise. The longer the current situation continues, it is more likelypurchase certain materials in bulk volumes where we have supply chain scarcity concerns. It remains possible that we may experience some sort of interruption to our supply chains, and such an interruption could materially affect our ability to timely manufacture and distribute our products and unfavorably impact our results of operations.
Clinical Trial DelaysWe are also starting to experience input cost inflation, including materials and labor. Pricing actions and supply chain productivity initiatives have mitigated and are expected to continue to mitigate some of these inflationary pressures, but we may not be successful in fully offsetting these incremental costs, which could have an impact on the Company’s consolidated results of operations and cash flows during 2022 and beyond.
As a result
Page 17

Product Development and Clinical Trials
Our Diagnostics segment’s new product development programs are continuing to see
“re-starts”
for certain clinical trials, the trials are being conductedprogress at a slower pace than normal, asdue in part to the prevalence of certain infectious diseases (e.g., bacterial gastrointestinal) hashaving been much lower than normal during the
COVID-19
pandemic. Such delaysThese matters continue to impact our timing for filing applications for product clearances with the FDA,U.S. Food and Drug Administration (“FDA”), as well as related timing of FDA clearances of such filings. Additionally, the ongoing
COVID-19
pandemic has slowed and could continue to slow down our efforts to expand our product portfolio through acquisitions andand/or 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 generally experienced unprecedented demand for certain of our molecular reagents (e.g., ribonucleic acid (“RNA”) master mixes and nucleotides). For the second half of, including a resurgence in such demand during our fiscal 2021 we expect demand for reagent products used in
COVID-19
tests will be lower than we experienced in our secondfourth quarter and throughout the first quarter of fiscal 2021, as health care systems transition2022. While we expect a continuation of this trend, this expectation will certainly be impacted by infection rates and the responses to more asymptomatic testing versus the predominant symptomatic testing we have seen over the last year. However, this variessuch levels of infection varying by country based on their individual
COVID-19
case statistics, infection rates and vaccine programs. We believe that our reagent products for
COVID-19
have applications in many alternative,
non-hospital-based
channels (e.g., airports, schools, etc.). Our products are used in over 100 approved
COVID-19
related assays around the world.
COVID-19
related reagent revenues totaled approximately $31,000 and $74,000 in the three and six months ended March 31, 2021, respectively, 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. Sales volumes for a number of these assays have been adversely affected by the
COVID-19
pandemic over the past year,two years, as such assays are often used in
non-critical
care settings.settings; however, we have seen indications of a return to more normal
pre-pandemic
levels. The
COVID-19
pandemic also has continued to affectdepressed instrument orders and placements for our instrument placements. The launch ofBreathID, Curian and Revogene platforms. Order activity for our CurianRevogene platform has been slower than expected, as diagnostic testing sites have turned their attention to critical care testing. Onwas affected by the other hand, as a result of announcing the development of a
SARS-CoV-2
assay (the “Revogene
Page 22

COVID-19
assay”) and subsequently submitting an application for the test to the FDA on December 7, 2020 under itsdelay in obtaining emergency use authorization (“EUA”) program, beginning infor our fiscal 2020 fourth quarter and continuing through the first quarter of fiscal 2021, we experienced an acceleration in Revogene instrument orders and placements. However, based upon a
mid-February
2021 discussion with the FDA related to certain information contained within the EUA application, on February 23, 2021, we announced our withdrawal of the EUA application and our intention to conduct a
Limit-of-DetectionSARS-CoV-2
bridging study and an updated clinical validation study, with the intention of
re-submitting
an EUA application for the Revogene
COVID-19
assay, which we expect to occur in June 2021. We will not resume shipments of the Revogene
COVID-19
assay until FDA EUA clearance. Understandably, these events resulted in a slow-down in orders for the Revogene system that were related to the anticipated COVID-19 assay. We believe this slow-down to be temporary, as potential customers taketook a “wait and see” approach while we work towardthroughout our entire EUA application process. We received the EUA on November 9, 2021 but have not yet begun to ship product, as our
re-submission
SARS-CoV-2
assay is currently being enhanced to detect the recently prevalent Omicron variant of the
COVID-19
infection. We anticipate completing the validation of these changes during the second quarter of fiscal 2022, with shipment of product to commence thereafter upon clearance by the FDA. Despite the situation encountered with our EUA application. In responseapplication for the
SARS-CoV-2
assay and the delay in shipment due to the high level of demandOmicron variant related enhancements, we have experienced since announcing development of the test, we are inproceeded with the process of increasing our capacity to produce these tests, as well as other tests on the Revogene system.platform, at our facilities in Quebec and Cincinnati. Specifically, we are: (i) addinghave added a second production line at our Quebec City, Canada manufacturing facility;facility and (ii)are installing two additional production lines in a leased facility near our corporate headquarters in Cincinnati, Ohio. It is expected thatCincinnati. With approximately $11,700 expended on these expansion efforts willthrough December 31, 2021, we expect them to be completed during fiscal 2021calendar 2022 at a total cost of approximately $18,000,$21,300, which is expected to be partially offset by the $5,500 RADxmonies received under the National Institutes of Health Rapid Acceleration of Diagnostics (“RADx”) initiative grant entered into on February 1, 2021, and as amended on January 25, 2022, $1,500 of which had been received as of December 31, 2021 (see Note 13 14,
“National Institutes of Health Contracts”
and Note 17,
“Subsequent Event”
of the Condensed Consolidated Financial Statements)Statements for further discussion).
Critical Accounting Estimates
For the three and six months ended MarchDecember 31, 2021, 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 ended 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 was ratified on April 28, 2021, and goes into effect on May 1, 2021. The agreement includes 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 dealsfiled 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 haveSEC 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 concern. 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 and Six Months Ended March 31, 2021
Net earnings for the second quarter of fiscal 2021 increased 181% to $26,302, or $0.60 per diluted share, from net earnings for the second quarter of fiscal 2020 of $9,359, or $0.22 per diluted share. Net earnings for the
six-month
period ended March 31, 2021 increased 336% to $53,081, or $1.21 per diluted share, from net earnings for the comparable fiscal 2020 period of $12,186, or $0.28 per diluted share. The level of net earnings in the second quarter (“QTD”) and first six months (“YTD”) of fiscal 2021 were affected by several factors, including most notably the combined effects of the following (amounts presented on a
pre-tax
basis) and a lower effective tax rate resulting in large part from a greater percentage of
pre-tax
earnings being generated in lower tax jurisdictions:November 23, 2021.
 
Page 2318

(i)
significantly higher revenue in the Life Science segment, due to supplying key reagents to diagnostic test manufacturers for use in
COVID-19
related PCR and immunoassay tests (up $30,961 QTD; up $80,927 YTD);
(ii)
higher research and development spending in the Diagnostics segment (up $745 QTD; up $1,640 YTD) under new product development programs;
(iii)
increased intangible asset amortization, primarily resulting from intangible amortization related to the acquisition of Exalenz in April 2020 (up $491 QTD; up $990 YTD);
(iv)
decreased acquisition-related costs, as compared to those related to the Exalenz transaction in April 2020 (down $1,787 both QTD and YTD);
(v)
increased legal expenses related primarily to the DOJ matter at the Billerica, Massachusetts facility (up $295 QTD; up $1,202 YTD);
(vi)
the fiscal 2021 periods including grant income related to the National Institutes of Health RADx initiative ($200 QTD; $1,000 YTD) (see Note 13 of the Condensed Consolidated Financial Statements); and
(vii)
the change from net currency gains in the fiscal 2020 periods to net currency losses in the fiscal 2021 periods ($2,286 change QTD; $2,250 change YTD), resulting primarily from movement in the British pound exchange rate.
Consolidated revenues for the second quarter of fiscal 2021 totaled $85,264, an increase of 49% compared to the second quarter of fiscal 2020 (45% increase on a constant-currency basis).
Revenues from the Diagnostics segment for the second quarter of fiscal 2021 decreased 9% compared to the second quarter of fiscal 2020 (10% decrease on a constant-currency basis), comprised of a 39% decrease in molecular assay products and a 1% decrease in
non-molecular
assay products. Reflecting the factors noted in the Product Demand section above, our Revogene system installed based totaled 325 at March 31, 2021, as compared to 288 at December 31, 2020.
With a 227% increase in revenues from molecular reagents products and a 44% increase in revenues from immunological reagents products, revenues for our Life Science segment increased 139% during the second quarter of fiscal 2021 compared to the second quarter of fiscal 2020. On a constant-currency basis, revenues for the Life Science segment increased 129%. 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 increased revenue levels during the second 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 $5,000, or approximately 32%, compared to the second quarter of 2020. This growth, including an approximate 83% 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.
Consolidated revenues increased 70% to $178,181 for the first six months of fiscal 2021 compared to the same period of the prior year (67% increase on a constant-currency basis). On a reportable segment basis, Diagnostics segment revenues decreased 11% (12% decrease on a constant-currency basis) and Life Science segment revenues increased 231% (222% increase on a constant-currency basis). The drivers of the fiscal
year-to-date
revenue levels are consistent with the drivers that resulted in the quarterly revenue levels, as detailed above and within the Revenue Overview section below.
Lead Testing Matters
On September 1, 2021, the Company’s wholly owned subsidiary Magellan announced the expansion of the Class I voluntary recall of its LeadCare test kits for the detection of lead in blood, which it had initiated in May 2021 after identifying an ongoing issue with the testing controls included in certain manufactured lots of its LeadCare test kits. As a result of the identified issue, impacted test kit lots could potentially underestimate blood lead levels when processing patient blood samples. Although it was initially believed that the root cause of the issue related to the plastic containers used for the treatment reagent, additional studies have indicated that the root cause relates to the third-party-sourced cardboard trays that hold the containers used for the treatment reagent. The Company continues to work closely with the FDA in its execution of the recall activities, which include Magellan notifying customers and distributors affected by the recall and providing instructions for the return of impacted test kits. The evaluation of the recall, the related notification process and correction of the identified supplier issue is ongoing. Of the approximate $5,100 estimated and accrued as of September 30, 2021 to cover the estimated costs of the recall, approximately $4,300 remains accrued and is reflected in the Condensed Consolidated Balance Sheet as of December 31, 2021. Anticipated recall-related costs primarily include product replacement and/or refund costs, mailing/shipping costs, attorneys’ fees and other miscellaneous costs.
As previously disclosed, on April 17, 2018, the Company’s wholly owned subsidiary Magellan received a subpoena from the U.S. Department of Justice (“DOJ”) regarding its LeadCare product line, whichline. The subpoena outlined documents to be produced. Since that time, we have receivedproduced, and respondedthe 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 related information requests andthat have followed receipt of the subpoena in April 2018. The Company has executed tolling agreements to extend the statute of limitations. In March and April 2021, DOJ issued two subpoenas calling for witnesses to testify before a federal grand jury related to this matter. The March 2021 subpoena was issued to a former employee of Magellan, and the April 2021 subpoena was issued to a current employee of Magellan. At this time, we do not knowIn September and October 2021, DOJ issued additional subpoenas to individuals seeking testimony and documents in connection with its ongoing investigation. It is the Company’s understanding that multiple witnesses have testified before the federal grand jury and the DOJ’s activity before the federal grand jury is ongoing. The Company cannot predict when the investigation will be resolved, the outcome of the investigation, or its potential impact on the Company. Approximately $281 and $1,227 of expense for attorneys’ fees related to this matter however, we continueis included within the Condensed Consolidated Statements of Operations for the three months ended December 31, 2021 and 2020, respectively.
Having issued a Warning Letter to cooperateMagellan on October 23, 2017 related to the Billerica location’s manufacturing of LeadCare testing systems for venous blood samples (the “Warning Letter”), on August 3, 2021, the FDA sent Magellan a
close-out
letter for the Warning Letter. The FDA’s
close-out
letter notified Magellan that the FDA has completed an evaluation of Magellan’s corrective actions in response to the FDA’s Warning Letter, and based on the FDA’s evaluation, Magellan has addressed the issues identified in the Warning Letter. The FDA’s
close-out
letter also stated that future FDA inspections of Magellan and regulatory activities will further assess the adequacy and sustainability of Magellan’s corrections. For a more detailed discussion of this matter, see the “Lead Testing Matters” section beginning on page 29 of the Company’s fiscal 2021 Annual Report on Form
10-K,
filed with the DOJ.SEC on November 23, 2021.
RESULTS OF OPERATIONS
Three Months Ended December 31, 2021
Net earnings for first quarter of fiscal 2022 decreased 43% to $15,340, or $0.35 per diluted share, from net earnings for the first quarter of fiscal 2021 of $26,779, or $0.61 per diluted share. The level of net earnings in the first quarter of fiscal 2022 resulted primarily from the decrease in net revenues and operating income in our Life Science segment, when compared to the record demand for the reagents utilized in
COVID-19
related tests during the first quarter of fiscal 2021. As a significant number of our Life Science segment customers use our molecular reagents in multiple tests, including
non-COVID-19
related tests, it has become increasingly difficult to accurately estimate the portion of molecular reagent sales related specifically to
COVID-19.
As a result, we are no longer reporting the portion of Life Science segment net revenues related to
COVID-19.
Such net revenues were identified and reported throughout fiscal 2021 and totaled approximately $43,000 and $111,900 in the first quarter and full year of fiscal 2021, respectively.
Consolidated net revenues for the first quarter of fiscal 2022 totaled $88,341, a decrease of 5% compared to the first quarter of fiscal 2021.
Notwithstanding the impact of the LeadCare recall, net revenues from the Diagnostics segment for the first quarter of fiscal 2022 increased 10% compared to the first quarter of fiscal 2021, comprised of a 4% increase in molecular assay products and an 11% increase in
non-molecular
assay products. The first quarter of fiscal 2022 represents the third consecutive quarter our Diagnostics segment has shown positive revenue growth versus the same quarter in the prior fiscal year. Our Diagnostics segment generated a $2,600 operating loss for the first quarter of fiscal 2022, compared to a $1,200 operating loss in the first quarter of fiscal 2021, reflecting the decrease in gross profit margins and increase in operating expenses described in the respective sections below.
 
Page 2419

Magellan submitted 510(k) applicationsWith a 32% decrease in December 2018, seeking to reinstate venous blood sample-typesnet revenues from molecular reagent products, and a 43% increase in net revenues from immunological reagent products, net revenues for its LeadCare II, LeadCare Plus and LeadCare Ultra testing systems. Inour Life Science segment decreased 12% during the second fiscalfirst 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 responsesfiscal 2022 compared 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 byfirst quarter of fiscal 2021, the FDA and permittedperiod in which the Life Science segment experienced near unprecedented demand from diagnostic test manufacturers for use with capillary blood samples,in
COVID-19
related tests. Our Life Science segment generated $26,500 of operating income for the FDA advised that it has commissionedfirst quarter of fiscal 2022, a third-party studydecline of Magellan’s LeadCare testing systems using both venous$13,300 from the first quarter of fiscal 2021, primarily resulting from the decrease in net revenues and capillary blood samples. According to the FDA, the results of the field study will be used in conjunction with other information to determine whether further action by the FDA or the CDC is necessary to protect the public health. Meridian intends to fully cooperate with the FDA as the third-party study is completed.
During October 2019, the FDA performed a
follow-up
inspection of Magellan’s manufacturing facility. The FDA issued five Form FDA 483 observations. On March 18, 2020, we participated in a regulatory meeting with the FDA at the FDA’s request to further discuss the Form FDA 483 observations and our remediation efforts. Over the last year, we have submitted a number of written responses to the FDA regarding the five Form FDA 483 observations issuedgross profit margins described in the October 2019 inspection, and have worked diligently to execute a remediation plan. During October 2020, the FDA issued Establishment Inspection Reports which closed out the inspections 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 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.
In the course of remediation, we may encounter additional matters that warrant notifications to the FDA and/or customers regarding the use of our products. At this time, we do not believe that any such notifications would impact the ability to use the LeadCare systems with capillary blood samples. While we remain confident in the performance of the Magellan LeadCare testing systems using capillary samples, we do not expect that the FDA will reinstate our venous blood claims. We can provide no assurance that the ongoing investigation and study of the DOJ and FDA, respectively, or future exercise of their respective enforcement, regulatory, discretionary or other powers will not result in findings or alleged violations of federal laws that could lead to enforcement actions, proceedings or litigation, and/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 on terms substantially similar to those on which we currently operate.
sections below.
REVENUE OVERVIEW
Below are analyses of the Company’s net revenues, provided for each of the following:
 
 -
By Reportable Segment & Geographic Region
 
 -
By Product Platform/Type
Revenue Overview- By Reportable Segment & Geographic Region
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 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 (including the
COVID-19
pandemic), 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 $31,000 and $74,000 during the second quarter and first six months of fiscal 2021, respectively.
See the “Revenue Disaggregation” section of Note 4,
“Revenue Recognition”
of the Condensed Consolidated Financial Statements for detailed revenue disaggregation information.
Page 25

Following is a discussion of the net revenues generated by these product platforms/types and/or disease states:
Diagnostics Segment Products
The acquisitionsDiagnostics segment’s overall 10% growth in net revenues during the first quarter 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 continue to convert our existing Alethia install basefiscal 2022 compared to the Revogene platform for the
C. difficile
, Group A
Streptococcus
(“Group A Strep”) and Group B
Streptococcus
(“Group B Strep”) assays. Reflecting the factors noted in the Product Demand section above, our Revogene system installed based totaled 325 at March 31, 2021, as compared to 288 at December 31, 2020.
In March 2020, we received clearance from the FDA for the Curian immunoassay diagnostics instrument and its first assay, a test for
H. pylori
antigen in stool. We began clinical trials for the Curian
C. difficile
Common Antigen and Toxins A and B test during the second quarter of fiscal 2021, and submitted a 510(k)
pre-market
notification toprimarily results from the FDA for marketing clearance of Curian Campylobacter on March 31, 2021. We believe the advantagescombined effects of the Curian analyzer will help protect our existing rapid test accounts, andfollowing:
Volume growth 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 levelsgastrointestinal products benefitting from sales of our gastrointestinal,the BreathTek product, acquired on July 31, 2021 (approximately $5,600 of net revenues from BreathTek in the first quarter of fiscal 2022);
Volume growth in sales of respiratory illness and blood chemistry products. Comprisedproducts, comprised of tests for Group A Strep, Mycoplasma pneumonia, Influenza, and Pertussis, among others, reflecting an increase in the respiratory illness category in particular continues to experience significantly lower sales activity relativetesting for these illnesses compared to the prior year, with revenues from sales of such products decreasing 66% and 54% during the second quarter and first six months of fiscal 2021, respectively. However, during the second quarter of fiscal 2021, we began to experience an increase indespite the ongoing
COVID-19
pandemic; and
Volume declines from sales activity for gastrointestinal andof blood chemistry products withdue to the ongoing LeadCare product recall, which commenced in May 2021 ($4,316 decrease in net revenues from each of these product categories increasing as follows compared to the secondfirst quarter of fiscal 2020: (i) gastrointestinal products, which include tests for
C. difficile2021).
,
H. pylori
and certain foodborne pathogens, among others, increased 12% to $15,666; and (ii) blood chemistry products, which test for elevated levels of lead in blood, increased 4% to $4,358. During the first six months of fiscal 2021, gastrointestinal product revenues increased 4% over the prior year period to $31,118, and blood chemistry product revenues decreased 4% to $8,753. The increases in the
H. pylori
component of our gastrointestinal family of products include contributions from the BreathID urea breath platform acquired in the Exalenz acquisition on April 30, 2020.
In order to combat certain of the pricing and volume pressures we face within the gastrointestinal product category, we have executed on a number of measures including: (i) entering into a strategic collaboration with DiaSorin to sell
H. pylori
tests; (ii) executing supply agreements with our two largest reference laboratory customers for
H. pylori
tests to secure volume, albeit at lower selling prices; and (iii) upon 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 combat competitive pressures, as 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 test format from a 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.
Life Science Segment Products
DuringDespite continuing to achieve net revenues levels that are significantly higher than
pre-pandemic
levels, the secondLife Science segment’s 12% decline in net revenues during the first quarter of fiscal 2022 primarily results from a year-over-year quarterly comparison to the record levels of demand achieved during the first quarter of fiscal 2021. As previously noted, it was during the first quarter of fiscal 2021 revenues fromthat our Life Science segment increased 139%, with revenues from molecular reagent sales increasing 227% from the comparable fiscal 2020 quarter and revenues from immunological reagent sales increasing 44%. Life Science segment revenues increased 231%experienced near unprecedented demand for the first six months of fiscal 2021, reflecting a 396% increase from molecular reagent sales and a 78% increase in immunological reagent sales. Our Life Science segment’s revenue performance was nominally impactedits products by the movement in currency exchange rates since the fiscal 2020 reporting periods, with revenues increasing 129% and 222% on a constant-currency basis over the second quarter and first six months of fiscal 2020, respectively. The increase in revenues was primarily attributable to sales of key molecular components such as RNA master mixes and dNTPs to diagnostic test manufacturers for use in
COVID-19
related PCR tests, as well as sales of
Page 26

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 $31,000 and $74,000 during the second quarter and first six months of fiscal 2021, respectively.
During the second quarter of fiscal 2021, revenue from our core Life Science segment business (other than
COVID-19
contributions) grew approximately 32% over the second quarter of fiscal 2020 to approximately $22,000. During the first six months of fiscal 2021, such revenue grew approximately 42% over the comparable fiscal 2020 period to approximately $41,600. This growth, including an approximate 83% and 85% increase in revenue from sales into China during the quarter and fiscal
year-to-date
period, respectively, resulted in large part from obtaining business from
COVID-19
customers who are now using our products for
non-COVID
related purposes, as well as a rebound in volumes of core immunological product sales.
Significant Customers
Revenue concentrations related to certain customers within our Diagnostics and Life Science segments are set forth in Note 14 15,
“Reportable Segments and Major Concentration Data”
of the Condensed Consolidated Financial Statements.
Gross Profit
   
Three Months Ended March 31,
  
Six Months Ended March 31,
 
   
2021
  
2020
  
Change
  
2021
  
2020
  
Change
 
Gross profit
  $57,772 $34,546    67 $119,320  $62,197  92
Gross profit margin
   68  60  8 points   67  59  8 points 
The increase in gross profit margin during the second quarter and first six months 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 the second quarter and first six months of fiscal 2021, approximately 44% and 47%, respectively, of consolidated revenues relate to sales of molecular reagent products by our Life Science segment, which are some of our higher margin products, as compared to sales of such products comprising approximately 20% and 16% of consolidated revenues during the second quarter and first six months of fiscal 2020, respectively.
Operating Expenses – Segment Detail
   
Three Months Ended March 31,
 
   
Research &
Development
   
Selling &
Marketing
   
General &
Administrative
   
Other
  
Total Operating
Expenses
 
Fiscal 2020:
         
Diagnostics
  $4,733  $5,401  $5,645  $(505 $15,274
Life Science
   582   1,128   2,772   103  4,585
Corporate
   —     —     2,211   685  2,896
                        
Total Expenses (2020 Quarter)
  $5,315  $6,529  $10,628  $283 $22,755
                        
Fiscal 2021:
         
Diagnostics
  $5,478  $5,220  $6,553  $(2,989 $14,262
Life Science
   587   1,320   3,077   —    4,984
Corporate
   —     —     3,295   1,030  4,325
                        
Total Expenses (2021 Quarter)
  $6,065  $6,540  $12,925  $(1,959 $23,571
                        
 
Page 2720

   
Six Months Ended March 31,
 
   
Research &
Development
   
Selling &
Marketing
   
General &
Administrative
   
Other
  
Total Operating
Expenses
 
Fiscal 2020:
         
Diagnostics
  $8,908  $10,797  $10,574  $812 $31,091
Life Science
   1,170   2,460   5,110   198  8,938
Corporate
   —     —     3,928   1,055  4,983
                        
Total Expenses (2020
Year-to-Date)
  $10,078  $13,257  $19,612  $2,065 $45,012
                        
Fiscal 2021:
         
Diagnostics
  $10,548  $10,948  $12,301  $(1,942 $31,855
Life Science
   1,168   2,613   6,531   —    10,312
Corporate
   —     —     6,031   2,257  8,288
                        
Total Expenses (2021
Year-to-Date)
  $11,716  $13,561  $24,863  $315 $50,455
                        
Gross Profit
   
Three Months Ended December 31,
 
   
2021
  
2020
  
Change
 
Gross Profit
  $49,159  $61,548   (20)% 
Gross Profit Margin
   56  66  -10 points 
Overall gross profit margins during the first quarter of fiscal 2022 have been unfavorably impacted by a decline in net revenues contributions from our Life Science segment’s molecular reagent products, which are some of our highest margin products. During the first quarter of fiscal 2022, approximately 36% of consolidated net revenues related to sales of molecular reagent products, compared to approximately 50% during the first quarter of fiscal 2021, when the Life Science segment experienced the to date peak in net revenues from sales of molecular reagent products.
Additionally, overall gross profit margins in the first quarter of fiscal 2022 have been unfavorably impacted in our Diagnostics segment by the previously discussed LeadCare product recall (see “Lead Testing Matters” above) and production capacity
ramp-up
costs at our Cincinnati and Quebec Revogene manufacturing facilities.
Operating Expenses – Comparisons to Prior Year PeriodsSegment Detail and Corporate
 
   
Three Months Ended March 31,
 
   
Research &
Development
  
Selling &
Marketing
  
General &
Administrative
  
Other
  
Total Operating
Expenses
 
2020 Expenses
  $5,315 $6,529 $10,628 $283 $22,755
% of Revenues
   9  11  19  -  40
Fiscal 2021 Increases/(Decreases):
      
Diagnostics
   745  (181  908  (2,484  (1,012
Life Science
   5  192  305  (103  399
Corporate
   —    —    1,084  345  1,429
                     
2021 Expenses
  $6,065 $6,540 $12,925 $(1,959 $23,571
                     
% of Revenues
   7  8  15  (2)%   28
% Increase (Decrease)
   14  -  22  NMF   4
   
Research &
Development
   
Selling &
Marketing
   
General &
Administrative
   
Other
   
Total Operating
Expenses
 
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 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
 
Fiscal 2022 First Quarter:
 
Diagnostics
  $5,556   $6,009   $7,143   $—     $18,708 
Life Science
   638    1,732    4,161    —      6,531 
Corporate
   —      —      3,356    281    3,637 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
 
Total 2022 First Quarter Expenses
  $6,194   $7,741   $14,660   $281   $28,876 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
 
Compared to the prior year period, operating expenses increased $1,992 to $28,876 in the first quarter of fiscal 2022. Major components of this increase were as follows:
Increased Research & Development costs, reflecting increased clinical trial spending and product development costs within our Diagnostics segment;
 
   
Six Months Ended March 31,
 
   
Research &
Development
  
Selling &
Marketing
  
General &
Administrative
  
Other
  
Total Operating
Expenses
 
2020 Expenses
  $10,078 $13,257 $19,612 $2,065  $45,012
% of Revenues
   10  13  19  2  43
Fiscal 2021 Increases/(Decreases):
      
Diagnostics
   1,640  151  1,727  (2,754  764
Life Science
   (2  153  1,421  (198  1,374
Corporate
   —    —    2,103   1,202   3,305
                     
2021 Expenses
  $11,716 $13,561 $24,863  315  $50,455
                     
% of Revenues
   7  8  14    28
% Increase (Decrease)
   16  2  27  (85)%   12
Increased Selling & Marketing costs in both the Diagnostics and Life Science segments, primarily reflecting the effects of filling certain open positions and the easing of certain travel and meeting restrictions imposed during the prior year in connection with the
COVID-19
pandemic; and
The changes in operating expenses
Increased General & Administrative costs, primarily reflectreflecting the combined effects of additional investment in incentive compensation, the following:timing of certain outside services costs and increased commercial insurance costs for Directors & Officers and Property & Casualty coverages.
1)
Increased Research & Development costs, primarily reflecting the development of the molecular
SARS-CoV-2
assay and molecular gastrointestinal and respiratory panel assays for the Diagnostics segment, and the addition of research and development expenses related to Exalenz, acquired in April 2020;
 
Page 2821

2)
Increased Selling & Marketing costs, primarily reflecting increased bonus and commissions paid early in fiscal 2021 to sustain the Diagnostics segment sales force during the downturn caused by the
COVID-19
pandemic, substantially offset by the effects of reduced travel from restrictions imposed during the pandemic and the effect such restrictions have had on general sales and marketing activities;
Offsetting these increases were: (i) a $1,047 year-over-year decrease in expense within our Diagnostics segment, resulting from the adjustment to the fair value of acquisition consideration in the fiscal 2021 first quarter; and (ii) lower spending on selected legal costs.
3)
Increased General & Administrative costs, primarily reflecting the addition of expenses related to Exalenz, including purchase accounting amortization, along with additional investment in incentive compensation; and
4)
Decreased Acquisition and Restructuring Costs and a decrease in the effect of changes in the fair value of the contingent consideration obligation for the GenePOC business, partially offset by increased Selected Legal Costs (reflected within “Other” in the above tables).
Operating Income
Compared to the prior year periods,period, operating income increased 190%decreased 41% to $34,201 for$20,283 in the secondfirst quarter of fiscal 2021 and increased 301% to $68,865 for the first six months of fiscal 2021,2022, as a result of the factors discussed above.
Income Taxes
The effective rate for income taxes was 20%approximately 22% for both the first quarter of fiscal 2022 and 21%fiscal 2021.
Impact of Inflation
To the extent feasible, we have consistently followed the practice of reviewing our prices to consider the impacts of inflation on salaries and fringe benefits for employees and the threecost of purchased materials and six months ended March 31, 2021, respectively, compared to 26%services. Inflation and 27% forchanging prices did not have a material adverse impact on our gross margin, revenues or operating income in the three and six months ended March 31, 2020, respectively. These lowerfirst quarter of fiscal 2021 effective tax rates result primarily from the combined effects of the following: (i) a significantly higher percentage of earnings before income taxes being generated in foreign jurisdictions with tax rates lower than the U.S., particularly the U.K.; (ii) the
non-deductibility2022 or fiscal 2021.
of a significant portion of the acquisition-related costs related to Exalenz; and (iii) the tax impact of restricted share unit lapses and stock option exercises occurring on dates when the share price of Company stock was significantly higher than the share price on the date such equity awards were granted.
Liquidity and Capital Resources
Liquidity
Our cash flow and financing requirements are determined by analyses of operating and capital spending budgets and debt 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.
We intend to continue to fund our working capital requirements from current cash flows from operating activities and cash on hand. Ifhand, and such sources are anticipated to be adequate to fund working capital requirements, capital expenditures and debt service during the next twelve months. However, if needed, we also have an additional source of liquidity through the amount remaining available on our $160,000$200,000 bank revolving credit facility, which totaled $110,000$150,000 as of MarchDecember 31, 2021. 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 six months of fiscal 2021, we generated cash flow from operations totaling $41,491. This level of cash resulted from the achievement of record fiscal
year-to-date
revenues, along with well-managed accounts receivable balances, including the requirement of advance payments in certain instances, as illustrated by an approximate 33% increase in second quarter fiscal 2021 consolidated revenues over the fourth quarter of fiscal 2020 and only an approximate 17% increase in accounts receivable balances since September 30, 2020.
Page 29

Our levels of inventories increased approximately $11,000 to $72,534 between September 30, 2020 and March 31, 2021. This increase was largely attributable to inventory builds in our Life Science segment 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 MarchDecember 31, 2021, our cash and cash equivalents balance was $63,374$72,729 or $9,860$22,958 higher than at the endSeptember 30, 2021. This increase primarily results from generating $35,555 of fiscal 2020. As a result of the cash generatedflow from operations, duringan increase of 42% over the secondfirst quarter and first six months of fiscal 2021, and the use of cash to pay down $10,000 on the revolving credit facility.
Considering these factors, our balance of netcash and cash equivalents on hand exceeded our total debt (defined as bank debt, government grant obligations and total contingent obligations related to the acquisition of the GenePOC business, net of cash and cash equivalents
on-hand)
decreasedacquisitions) by approximately $35,600 to approximately $16,700$16,000 at MarchDecember 31, 2021. 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 twelve months.
Capital Resources
As described in Note 11,12,
“Bank Credit Arrangements”
of the Condensed Consolidated Financial Statements, the Company maintains a $160,000$200,000 revolving credit facility, which is secured by substantially all of our U.S. assets and includes certain restrictive financial covenants. The Company also maintains a shelf registration statement on file with the SEC.
Our
Page 22

During fiscal 2022 our capital expenditures are estimated to range betweentotal approximately $18,000$15,000, comprised of approximately $12,000 and $24,000. Our$3,000 in the Diagnostics and Life Science segments, respectively. Included within the Diagnostics segment capital expenditures could be as high as $21,000, depending upon the level and timingestimate is approximately $10,400 related to completion of the previously noted Revogene
COVID-19
assay productionmanufacturing 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.automation initiatives for Revogene assay production. Such expenditures may be funded with cash and cash equivalents on hand, operating cash flows, and/or availability under the $160,000$200,000 revolving credit facility discussed above. In addition, a portion of the Diagnostics segment expansion may be funded by the remaining amounts to be received under the previously noted $5,500 RADx grant entered into on February 1, 2021, and as amended on January 25, 2022 (see Note 13 14,
“National Institutes of Health Contracts”
and Note 17,
“Subsequent Event”
of the Condensed Consolidated Financial Statements for further discussion).
License Agreements
The Company has entered into various license agreements that require payment of royalties based on a specified percentage of sales of related products. During the first quarter of fiscal 2022, royalty expense totaled approximately $800, with 35% and 65% of such expense relating to our Diagnostics and Life Science segments, respectively. This compares to a total of approximately $450 of royalty expense in the first quarter of fiscal 2021, with 70% and 30% relating to our Diagnostics and Life Science segments, respectively. The Company expects that payments under these agreements will amount to approximately $3,000 in fiscal 2022, a decrease from the $5,200 in fiscal 2021.
Off-Balance
Sheet Arrangements
We utilize foreign currency exchange forward contracts to limit exposure to volatility in foreign currency gains and losses related to financial assets denominated in other than the holding subsidiary’s functional currency. These contracts are generally settled within a
30-day
time frame and are not formally designated or accounted for as accounting hedges. We also utilize interest rate swap agreements to limit exposure to volatility in the LIBOR interest rate in connection with the revolving credit facility. The interest rate swap agreements are designated and accounted for as accounting hedges (see Note 5,
“Fair Value Measurements”
of the Condensed Consolidated Financial Statements).
We Aside from these instruments, we do not utilize any special-purpose financing vehicles or have any material undisclosed
off-balance
sheet arrangements.
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
There have beenAs of December 31, 2021, there were no material changes to the information provided under Item 7A, “Quantitative and Qualitative Disclosures About Market Risk” in the Company’s exposure to market risk sinceForm
10-K
for the year ended September 30, 2020.
2021, filed with the SEC on November 23, 2021.
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 FinancialPrincipal Accounting 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 MarchDecember 31, 2021. Based on this evaluation, our Chief Executive Officer and Chief FinancialPrincipal Accounting Officer have concluded that the Company’s disclosure controls and procedures were effective as of March 31, 2021.the period covered by this report.
Control systems, no matter how well designed and operated, can provide only reasonable, not absolute, assurance that control objectives are met. Because of inherent limitations in all control systems, no evaluation of controls can provide assurance that all control issues and instances of fraud, if any, within a company will be detected. Additionally, controls can be circumvented by individuals, by collusion of two or more people or by management override. Over time, controls can become inadequate because of changes in conditions or the degree of compliance may deteriorate. Further, the design of any system of controls is based in part upon assumptions about the likelihood of future events. There can be no assurance that any design will succeed in achieving its stated goals under all future conditions. Because of the inherent limitations in any cost-effective control system, misstatements due to errors or fraud may occur and not be detected.
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Changes in Internal Control over Financial Reporting
In the ordinary course of business, we routinely enhance our information systems by either upgrading current systems or implementing new ones. 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 MarchDecember 31, 2021 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
Page 30

PART II. OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
SeeInformation with respect to legal proceedings can be found in Note 16,7,
LitigationLead Testing Matters”
of the Condensed Consolidated Financial Statements.Statements in Part I, Item 1 of this Quarterly Report on Form
10-Q
and is incorporated herein by reference.
ITEM 1A. RISK FACTORS
In addition to the other information set forth in this report, careful consideration should be given to the factors discussed in Item 1A, “Risk Factors” in our Annual Report on Form
10-K
for the year ended September 30, 2021, filed with the SEC on November 23, 2021, as may be supplemented by our Quarterly Reports on Form
10-Q,
any or all of which could materially affect our business, financial condition or future results. The risks described therein are not the only risks facing us. Additional risks and uncertainties not currently known to us, or that we currently deem to be immaterial, also may adversely affect our business, financial condition and/or operating results. There have been no material changes fromwith respect to the risk factors as previously disclosed in the Company’s fiscal 2020our Annual
Report on Form
10-K
in response to Item 1A to Part I offor the year ended September 30, 2021, filed with the SEC on November 23, 2021, as may be supplemented by our Quarterly Reports on Form
10-K.10-Q.
ITEM 6. EXHIBITS
The following exhibits are being filed or furnished as a part of this Quarterly Report on Form
10-Q:
 
10.110.1* + Chief Executive Officer Cash-Based Incentive Compensation Plan for Fiscal Year 2022
10.2* +Executive Vice President Cash-Based Incentive Compensation Plan for Fiscal Year 2022
10.3* +Form of Performance-Based Restricted Share Unit Award Agreement
10.4Amended and Restated Credit Agreement, dated as of October 25, 2021, by and among Meridian Bioscience, Inc. 2021 Omnibus Award Plan (incorporated, as Borrower, the Guarantors party thereto, the Lenders party thereto, PNC Bank, National Association, as administrative agent, PNC Capital Markets LLC, as joint lead arranger and sole bookrunner, and Fifth Third Bank, National Association, as joint lead arranger and syndication agent (Incorporated by reference to Exhibit 10 to the Company’s Registration Statement onMeridian’s Form S-8 (File No. 333-252538)8-K filed with the Securities and Exchange CommissionSEC on JanuaryOctober 29, 2021)
31.1 Certification of Principal Executive Officer Pursuant to Securities Exchange Act Rule 13a-14(a)/15d-14(a)
31.2 Certification of Principal FinancialAccounting Officer Pursuant to Securities Exchange Act Rule 13a-14(a)/15d-14(a)
32 Certification of Chief Executive Officer and Chief FinancialPrincipal Accounting Officer pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
Page 24

101.INS  Inline XBRL Instance Document
101.SCH  Inline XBRL Instance Extension Schema
101.CAL  Inline XBRL Instance Extension Calculation Linkbase
101.DEF  Inline XBRL Instance Extension Definition Linkbase
101.LAB  Inline XBRL Instance Extension Label Linkbase
101.PRE  Inline XBRL Instance Extension Presentation Linkbase
104  Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101)
 
*
Management Compensatory Contracts
Page 31

+
Certain portions of these exhibits 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 schedule or other portion to the SEC upon request.
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
 
   
MERIDIAN BIOSCIENCE, INC.
Date:
May 7, 2021February 4, 2022
  By: 
/s/ Bryan T. BaldasareJulie Smith
   Bryan T. BaldasareJulie Smith
   
ExecutiveSenior Vice President and Chief Financial OfficerController
(Principal Financial and Accounting Officer)
 
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