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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-K
☒
ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
FOR THE FISCAL YEAR ENDED SEPTEMBER 30, 2021.
☐
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
FOR THE TRANSITION PERIOD FROM TO
Commission File No. 0-14902
MERIDIAN BIOSCIENCE, INC.
3471 River Hills Drive
Cincinnati, Ohio 45244
IRS Employer ID No. 31-0888197
State of Incorporation: Ohio
Phone: (513) 271-3700
Securities registered pursuant to Section 12(b) of the Act:
Title of each class
Trading Symbol
Name of each exchange on which registered
Common Shares, No Par Value
VIVO
The NASDAQ Stock Market LLC
(NASDAQ Global Select Market)
Securities registered pursuant to Section 12(g) of the Act:
None
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. YES ☒ NO ☐
Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Act. YES ☐ NO ☒
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Indicate by 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 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, a smaller reporting company, or an
emerging growth company. See the 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 has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control
over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or
issued its audit report. ☒
Indicate by check mark whether the registrant is a shell company (as defined in Exchange Act Rule 12b-2). YES ☐ NO ☒
The aggregate market value of Common Shares held by non-affiliates as of March 31, 2021 was $1,132,216,391 based on a closing sale price of $26.25 per
share on March 31, 2021. As of October 31, 2021, 43,364,448 shares of Common Stock, no par value, were issued and outstanding.
DOCUMENTS INCORPORATED BY REFERENCE
Portions of the Proxy Statement for the 2022 Annual Meeting of Shareholders, which will be filed within one hundred and twenty days of the fiscal year
ended September 30, 2021 (2022 Proxy Statement), are incorporated by reference into Part III of this report to the extent described herein.
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MERIDIAN BIOSCIENCE, INC.
INDEX TO ANNUAL REPORT
ON FORM 10-K
Page
Part I
Item 1
Business
5
Item 1A
Risk Factors
11
Item 1B
Unresolved Staff Comments
24
Item 2
Properties
24
Item 3
Legal Proceedings
24
Item 4
Mine Safety Disclosures
25
Part II
Item 5
Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities
25
Item 6
Intentionally Omitted
26
Item 7
Management’s Discussion and Analysis of Financial Condition and Results of Operations
26
Item 7A
Quantitative and Qualitative Disclosures about Market Risk
37
Item 8
Financial Statements and Supplementary Data
38
Item 9
Changes in and Disagreements with Accountants on Accounting and Financial Disclosure
74
Item 9A
Controls and Procedures
74
Item 9B
Other Information
75
Part III
Item 10
Directors, Executive Officers and Corporate Governance
75
Item 11
Executive Compensation
75
Item 12
Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
76
Item 13
Certain Relationships and Related Transactions, and Director Independence
76
Item 14
Principal Accountant Fees and Services
76
Item 15
Exhibits and Financial Statement Schedules
76
Item 16
Form 10-K Summary
78
NOTE ABOUT FORWARD-LOOKING STATEMENTS
This report includes estimates, projections, statements relating to our business plans, objectives, and expected operating results that are “forward-looking
statements” within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, and Section 21E of the
Securities Exchange Act of 1934. Forward-looking statements may appear throughout this report, including the following sections: “Business” (Part I,
Item 1 of this Form 10-K), “Risk Factors” (Part I, Item 1A of this Form 10-K), and “Management’s Discussion and Analysis of Financial Condition and
Results of Operations” (Part II, Item 7 of this Form 10-K). These forward-looking statements generally are identified by the words “believe,” “project,”
“expect,” “anticipate,” “estimate,” “intend,” “strategy,” “future,” “opportunity,” “plan,” “may,” “should,” “will,” “would,” “will be,” “will continue,” “will
likely result,” and similar expressions. Forward-looking statements are based on current expectations and assumptions that are subject to risks and
uncertainties that may cause actual results to differ materially. We describe risks and uncertainties that could cause actual results and events to differ
materially in “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” “Quantitative and Qualitative
Disclosures about Market Risk” (Part II, Item 7A of this Form 10-K) and elsewhere in this Form 10-K. Readers are cautioned not to place undue reliance on
forward-looking statements, which speak only as of the date they are made. We undertake no obligation to update or revise publicly any forward-looking
statements, whether because of new information, future events, the novel coronavirus (“COVID-19”) pandemic, or otherwise.
Unless the context requires otherwise, references in this Annual Report on Form 10-K (“Form 10-K”) to “Meridian,” “we,” “us,” “our,” “Company,” or
“our company” refer to Meridian Bioscience, Inc. and its subsidiaries.
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In the discussion that follows, all dollar amounts and share amounts are in thousands (both tables and text), except per share data.
This Form 10-K refers to trademarks such as Alethia ® , BreathID ® , BreathTek ® , Curian ® , HpSA ® , Immuno Card ® , Immuno Card STAT! ® ,
LeadCare ® , MyTaq ™ , PREMIER ® , revogene ® and SensiFAST ™ , which are protected under applicable intellectual property laws and are our property.
Solely for convenience, our trademarks and tradenames referred to in this Form 10-K may appear without the ® or ™ symbols, but such references are not
intended to indicate in any way that we will not assert, to the fullest extent under applicable law, our rights to these trademarks and tradenames. Our
molecular diagnostic test platform formerly known under the tradenames illumi gene and illumi pro , has been rebranded under the tradename Alethia.
References to Alethia throughout this Form 10-K refer to our molecular diagnostic tests and instrumentation formerly marketed and sold under the illumi
gene and illumi pro brands. Such references are not intended to indicate, in any way, that we will not assert, to the fullest extent permitted by law, our rights
to our trademarks.
WEBSITE AND SOCIAL MEDIA DISCLOSURE
We use our website ( www.meridianbioscience.com ) and our corporate Facebook, Instagram, LinkedIn, Twitter, Vimeo and YouTube accounts as channels
of distribution of company information. The information we post through these channels may be deemed material. Accordingly, investors should monitor
these channels, in addition to following our press releases, Securities and Exchange Commission (“SEC”) filings and public conference calls and webcasts.
The contents of our website and social media channels are not, however, a part of this report.
MARKET AND INDUSTRY INFORMATION
Market data used throughout this Form 10-K is based on management’s knowledge of the industry and good faith estimates of management. All of
management’s estimates presented herein are based on industry sources, including analyst reports and management’s knowledge. We also relied, to the
extent available, upon management’s review of independent industry surveys and publications prepared by a number of sources and other publicly available
information. We are responsible for all of the disclosures in this Form 10-K and while we believe that each of the publications, studies and surveys used
throughout this Form 10-K are prepared by reputable sources, we have not independently verified market and industry data from third-party sources.
All of the market data used in this Form 10-K involves a number of assumptions and limitations, and you are cautioned not to give undue weight to such
estimates. While we believe the estimated market position, market opportunity and market size information included in this Form 10-K is generally reliable,
such information, which in part is derived from management’s estimates and beliefs, is inherently uncertain and imprecise and has not been verified by any
independent source. Projections, assumptions and estimates of our future performance and the future performance of the industry in which we operate are
subject to a high degree of uncertainty and risk due to a variety of factors, including those described in “Item 1A. Risk Factors” of Part I of this Form 10-K
and elsewhere in this Form 10-K. These and other factors could cause results to differ materially from those expressed in our estimates and beliefs and in
the estimates prepared by independent parties.
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PART I.
ITEM 1.
BUSINESS
Overview
Meridian is 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, specialized Polymerase Chain Reaction (“PCR”) master mixes, and bioresearch
reagents used by other diagnostic test manufacturers and researchers in immunological and molecular tests for human, animal, plant and environmental
applications.
Our website is www.meridianbioscience.com . We make available our Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on
Form 8-K, Proxy Statements and any amendments thereto, free of charge through this website, as soon as reasonably practicable after such material has
been electronically filed with or furnished to the SEC. The SEC maintains an internet site containing these filings and other information regarding Meridian
at www.sec.gov . The information on our website is not and should not be considered part of this Form 10-K.
Reportable Segments
Our reportable segments are Diagnostics and Life Science, both of which are headquartered in Cincinnati, Ohio. We describe these reportable segments in
this “Business” section and in other locations in this report:
Type of Segment Information
Location within Form 10-K
Physical locations and activities
Item 2. “Properties”
Revenue by geographic region
Item 7. “Management’s Discussion and Analysis of
Financial Condition & Results of Operations”
(hereafter “MD&A”)
Financial information
Item 8. “Note 15 of Consolidated Financial
Statements”
Diagnostics Segment
Products and Markets
Prior to the onset of the COVID-19 pandemic early in 2020, our largest source of net revenues was clinical diagnostic products, historically representing
approximately two-thirds of our consolidated net revenues. However, primarily due to the effects of the COVID-19 pandemic, our Diagnostics segment
provided 40% of consolidated net revenues for fiscal 2021, following 48% of consolidated net revenues for fiscal 2020. In 2022, we expect our Diagnostics
segment to contribute approximately 50% of our consolidated net revenues.
Our clinical diagnostic products provide accuracy, simplicity and speed; enable early diagnosis and treatment of acute medical conditions; and provide for
better patient outcomes at reduced costs. We target diagnostics for disease states that: (i) are conditions where rapid diagnosis impacts patient outcomes;
(ii) have opportunistic demographic and disease profiles; (iii) are underserved by current diagnostic products; and/or (iv) have difficult sample handling
requirements (e.g., stool). This approach has allowed us to establish meaningful market share in our target disease states, gastrointestinal and respiratory
illnesses, and tests for elevated lead levels in blood.
Our product portfolio includes just under 200 diagnostic tests and transport media, and is marketed to acute care hospitals, reference laboratories, outpatient
clinics and physician office laboratories in over 70 countries around the world. Our testing platforms include: Real-time PCR Amplification (Revogene
brand); Isothermal DNA Amplification (Alethia brand); Lateral Flow Immunoassay using fluorescent chemistry (Curian brand); Rapid Immunoassay
(Immuno Card and Immuno Card STAT! brands); Enzyme-linked Immunoassay (PREMIER brand); Anodic Stripping Voltammetry (LeadCare brands);
and urea breath testing for H. pylori (BreathID and BreathTek brands).
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Our diagnostic assay research and development programs are focused on menu expansion for our Curian and Revogene instrument platforms, with disease
targets in the gastrointestinal and respiratory areas, as well as next generation blood-chemistry testing. Currently pending clearance at the U.S. Food and
Drug Administration (“FDA”) is a 510(k) application for the Curian Campylobacter assay. Our current new product development pipeline includes
gastrointestinal and respiratory multi-plex assays on our Revogene instrument platform, and EHEC Shiga Toxin and C. difficile combo common antigen and
Toxins A and B on our Curian instrument platform. In addition, we have other assays on both platforms moving through our upstream marketing assessment
processes that are expected to add to the development pipeline. For our BreathID platform, we are actively looking at the feasibility of combining Urea and
Citrica into a single sachet or pouch, which would meaningfully improve our cost of manufacturing BreathID assays. We are also pursuing opportunities to
complement our internal research and development programs by securing rights to finished diagnostics tests that we can immediately commercialize.
The April 2020 acquisition of Exalenz Bioscience Ltd. (“Exalenz”) and the BreathID system, along with the July 2021 acquisition of the BreathTek
business, strengthened our position in H. pylori testing, as these products provide an alternative non-invasive testing approach versus stool antigen testing.
Market Trends
Despite the effects of the COVID-19 pandemic and the intense focus on SARS-CoV-2 testing, we believe the global market for infectious disease tests
continues to expand as new disease states are identified, new therapies become available, and worldwide standards of living and access to health care
improve. There is a continuing shift from conventional testing to more technologically advanced testing, which can be performed by less highly trained
personnel and completed in minutes or hours.
The growing global pressures to contain total health care costs have accelerated the increased use of diagnostic testing. Integrated Delivery Networks
(“IDNs”) in our U.S. market have the goal of increasing the efficiency of health care delivery, reducing spending and improving clinical outcomes. We
believe our product portfolio positions us competitively with IDNs and health care systems that are transitioning from fee-for-service compensation models
to value-based reimbursement.
We also continue to see aggregation of buying power in our U.S. market via multi-hospital group purchasing organizations and IDNs, consolidation among
reference laboratories, hospital laboratories being operated by large reference laboratories, and acquisition of physician practices by hospitals, health
systems and for-profit specialty health care companies.
Cost containment pressures have also affected health care systems outside the U.S., particularly in Europe, where the health care systems are generally
government-run. The level of government budget deficits can have an adverse effect on the amount of government health care spend.
Sales, Marketing and Distribution
Our Diagnostics segment relies on direct sales personnel and independent distribution networks. We have a direct sales force in four countries, covering the
United States (“U.S.”) and certain major markets in the EMEA region (i.e., in Europe, the Middle East and Africa). We also use independent distributors
either in a complementary manner with our direct sales force (e.g., the U.S.) or solely to supply our products to end-users. We have two independent
distribution customers and a reference laboratory customer that together comprised 33% of Diagnostics segment net revenues in fiscal 2021, with each
contributing 10% or greater of the Diagnostics segment’s net revenues.
Competition
Our major competitors in molecular diagnostics are Cepheid (a Danaher business) and Becton Dickinson, both of which have systems with multiple-assay
menus. We also face competition in molecular diagnostics, but to a lesser degree, from companies such as Abbott (former Alere business) and Quidel.
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Our major competitors in rapid immunoassay diagnostics are primarily Abbott (former Alere business) and Quidel. In recent years, companies such as
bioMerieux have captured market share in our gastrointestinal category via its BioFire multi-plex panel tests. However, since their introduction to the
market, payors have raised concerns over reimbursement levels relative to clinical utility, particularly for panels with 12 or more targets.
For blood lead testing, we believe we have the only FDA-cleared, CLIA-waived point-of-care test available commercially. Other blood lead testing systems
in use, marketed by our competitors, include Graphite Furnace Atomic Absorption Spectroscopy, which requires a highly skilled technician and larger
laboratory space to operate, in addition to not being portable or suitable for point-of-care use. See product recall discussion included in “Lead Testing
Matters” beginning on page 29 within MD&A.
Research and Development
Our Diagnostics segment’s research and development personnel are organized into three pre-clinical teams: immunoassay, PCR-based molecular and blood-
chemistry. We have a separate team responsible for execution of clinical trials across all three pre-clinical programs. Our research and development
activities are focused on new product and new technology development, new applications for our existing technologies, and improvements to existing
products, including assay-menu expansion. Research and development efforts may occur in-house or with collaborative partners. We believe that new
product development is a key source for sustaining revenue growth. The products within our Revogene and Alethia molecular platforms, H. pylori product
family and blood lead testing family were developed in-house.
Manufacturing
Our diagnostics products are manufactured at four principal sites in Billerica, Massachusetts (blood-chemistry); Cincinnati, Ohio (immunoassays and
molecular tests); Modi’in, Israel, (urea breath tests for H. pylori ); and Quebec City, Quebec, Canada (molecular tests). Our immunoassay and molecular
assay products require the production of highly specialized reagents, primers and enzymes, and our BreathID and BreathTek products require the production
of urea in pharmaceutical-grade form. We produce the vast majority of our own immunoassay requirements. Reagents, primers and enzymes for our
Revogene molecular assay products, primers for our Alethia molecular assay products, and urea for our BreathID and BreathTek systems are purchased
from outside vendors. Our blood lead testing products require the production of electrical chemical sensors, which we manufacture using critical raw
materials purchased from outside vendors.
Intellectual Property, Patents and Licenses
We own or license U.S. and foreign patents, most of which are for select products manufactured by our Diagnostics segment. These patents are used in our
manufacturing processes for select products (e.g., method patents) or may relate to the design of the test device technology format (e.g., design patents). In
the absence of patent protection, we may be vulnerable to competitors who successfully replicate our production and manufacturing technologies and
processes. Our employees are required to sign confidentiality and non-disclosure agreements designed to protect our proprietary products.
The patents applicable to our Alethia products, which represented 4%, 7% and 12% of consolidated net revenues for fiscal 2021, 2020 and 2019,
respectively, have been and continue to be licensed from a third party, Eiken Chemical Co., Ltd., under a non-exclusive license agreement, with the last
remaining U.S. patent expiring in 2022.
The patents for the Revogene platform and related products acquired as part of the GenePOC business are either wholly owned or licensed from two third
parties, Laval University and The Regents of California, under an exclusive license agreement. These patents are issued in the U.S., European Union (“EU”)
and other countries. The term of our exclusive license agreement and the related patents currently runs through June 15, 2034, after which we will be free to
practice the patents without any restriction or royalty obligation. In September 2021, the U.S. Patent and Trademark Office granted to Meridian Bioscience
Canada Inc. (a wholly owned subsidiary) and Laval University a patent for our current Revogene test device and its microfluidic use in our Revogene
instrument.
The patents for the BreathID system and related urea breath test for H. pylori are either wholly owned or licensed from a third party, Oridion Medical 1987
Ltd., under an exclusive, royalty free, license agreement. The licensed and wholly owned patents are issued in the U.S., EU, Israel, Japan, Australia and
China. The wholly owned patents have varying expiration dates, with the last being in 2033.
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The patents for our stool antigen H. pylori products, owned by us and which represented approximately 7%, 9% and 17% of consolidated net revenues for
fiscal 2021, 2020 and 2019, respectively, expired in May 2016 in the U.S. and in May 2017 in countries outside the U.S. As a result, competition with
respect to our stool antigen H. pylori products has increased, adversely impacting our selling prices for these products, and/or our ability to retain business
at prices acceptable to us. To mitigate certain of the pricing and volume pressures we face within the gastrointestinal product category, we have: (i) operated
under a strategic collaboration agreement with DiaSorin to sell H. pylori tests; (ii) adjusted selling prices to secure volume; and (iii) upon FDA clearance in
March 2020, launched 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 BreathID and BreathTek products to mitigate competitive pressures, as these products provide an alternative non-invasive option
to stool antigen testing. 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 net revenues and gross profit.
Government Regulation
Our diagnostic products are regulated by the FDA as “devices” pursuant to the Federal Food, Drug, and Cosmetic Act (“FDCA”). Under the FDCA,
medical devices are classified into one of three classes (i.e., Class I, II or III). Class I and II devices are not expressly approved by the FDA, but, instead, are
“cleared” for marketing. Class III devices generally must receive “pre-market approval” (“PMA”) from the FDA as to safety and effectiveness. Our
diagnostics manufacturing facilities are subject to periodic inspection by the FDA. See page 29 within MD&A for discussion regarding the FDA’s
inspection of our Billerica facility.
Each of the diagnostic products currently marketed by Meridian in the U.S. has been cleared, approved or authorized for use by the FDA or are exempt from
such requirements. The majority of such products have been cleared by the FDA pursuant to its 510(k) clearance process, with our BreathTek product
having been approved under the FDA’s PMA process. In the case of our Revogene SARS-CoV-2 test, it has not been FDA cleared or approved but rather
has been authorized by the FDA for emergency use under its Emergency Use Authorization (“EUA”) process. We believe that most products under
development will be classified as Class I or II medical devices and, in the case of most of our Class I and all Class II devices, will be eligible for 510(k)
clearance; however, we can make no assurances in this regard. Our urea breath test for H. pylori on the BreathID system was cleared as a Class I medical
device since the urea drug component was approved by the FDA separately via the New Drug Application process. Our urea breath test for H. pylori on the
BreathTek system was approved by the FDA via the PMA process in 2012. Our SARS-CoV-2 test on the Revogene platform was submitted to the FDA
under its EUA program on June 25, 2021, with EUA being granted on November 9, 2021.
Sales of our diagnostic products in foreign countries are subject to foreign government regulation, which is similar to that of the FDA. Our Diagnostics
segment facilities are certified to ISO 13485.
Following a five-year transition period, sales of our diagnostic products in the EU will be subject to new regulations under the In Vitro Diagnostics
Regulation of 2017 (“IVDR”) beginning in May 2022. IVDR replaces the previous IVD Regulation (98/79/EC). In October 2021, the European
Commission submitted a proposal to the European Parliament that would move back the May 2022 implementation date for diagnostic tests that are
currently CE Marked to dates ranging from May 2025 to May 2028, depending on the risk classification of the diagnostic test. We have completed an
assessment of needed remediation activities to comply with IVDR and also determined that several products will not be sellable under IVDR. The net
revenues associated with these products are not expected to be material. New diagnostic products launched after May 2022 are required to comply with
IVDR.
Life Science Segment
Products and Markets
Our Life Science segment develops, manufactures, sells and distributes bulk antigens, antibodies, immunoassay blocking reagents, specialized PCR master
mixes, isothermal reagents, enzymes, nucleotides, and bioresearch reagents used predominantly by in vitro device (“IVD”) manufacturing companies, and
to a lesser degree, by researchers and non-human clinical customers such as veterinary, food and environmental. The COVID-19 pandemic has provided the
opportunity for our Life Science segment to showcase the breadth of its reagent products across not only SARS-CoV-2 testing platforms (molecular, rapid
antigen and serology), but also RNA and DNA based molecular tests for nearly any infectious disease. For fiscal 2021, approximately 87% of Life Science
segment net revenues were generated from the industrial market, defined as IVD manufacturers, and reagents for use in SARS-CoV-2 tests contributed
approximately $111,900 of net revenues, following $71,500 in fiscal 2020. We engage direct sales teams in the U.S., the United Kingdom (“U.K.”), France,
Germany, China and Australia. During fiscal 2021, 22% of net revenues for this segment were from three IVD manufacturing customers.
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Our Life Science segment products are marketed to IVD manufacturing customers as a source of raw materials for their human clinical diagnostics tests, or
as an outsourced step in their manufacturing processes. Selectively, we seek and maintain multi-year supply arrangements to provide stability in volumes
and pricing. Independent distributors market our molecular biology products to academic/research customers. These products are used in detecting DNA
and RNA in human, animal, plant and environmental applications.
Market Trends
Major IVD manufacturing customers often have global footprints, where we are supplying reagents to specific manufacturing sites around the world. IVD
manufacturers in specific countries of the Asia-Pacific region (e.g., China) are increasing their efforts in the development and manufacturing of infectious
disease tests. We intend to use the breadth of our product portfolio, particularly molecular reagents, to continue to increase the penetration of our products in
IVD manufacturing customers’ tests, regardless of customer class (large multi-national companies or regional companies).
Competition
The market for bulk biomedical reagents is highly competitive with respect to product quality, price, customer service and reputation. Our competitors, such
as Thermo Fisher, often have greater financial, research and development, sales and marketing, and manufacturing resources. Customers also may choose to
manufacture their biomedical reagents in-house rather than purchase from us.
Research and Development
Our research and development activities for the Life Science segment focus on molecular reagents for use in PCR and isothermal chemistries in detecting
both DNA and RNA. Our new product development programs are progressing through sample-specific (e.g., blood, saliva, urine, stool, and plant) mixes in
both air-dryable and lyophilization-ready forms, and isothermal reagents in both air-dryable and lyophilization-ready forms. We also have enzyme
development programs that meet the EU Registration, Evaluation, Authorization, and Restriction of Chemicals regulation. See “Operating Expenses”
section on page 33 within MD&A.
Manufacturing and Government Regulation
Our Life Science segment facilities are ISO 13485 certified, and where appropriate, our Life Science segment facilities comply with Regulation EC 1069.
International Markets
International markets are an important source of net revenues and future growth opportunities for both of our reportable segments. For both reportable
segments combined, net revenues from customers located outside of the U.S. and its territories approximated $173,000 or 55% of consolidated 2021 net
revenues, $122,000 or 48% of consolidated 2020 net revenues, and $74,000 or 37% of consolidated 2019 net revenues. Since the outbreak of the
COVID-19 pandemic in fiscal 2020 and throughout fiscal 2021, a significantly higher percentage of our Life Science segment’s net revenues have been
generated from international markets, and we expect to continue to look to key European and Asian markets as a source of revenue growth. For the Life
Science segment, we also continue to focus resources on IVD manufacturing customers in China, India, Japan and Korea. To date, we have not experienced
any adverse effects from the trade tensions between the U.S. and China, but we cannot be sure that we will not experience any adverse effects in the future.
Fluctuations in foreign currency exchange rates in fiscal 2021 compared to fiscal 2020 had an approximate $9,200 favorable impact on consolidated 2021
net revenues; $1,300 within the Diagnostics segment and $7,900 within the Life Science segment. This compares to year-to-year currency exchange rates
having an approximate $1,250 unfavorable impact on consolidated net revenues in 2020; $150 within the Diagnostics segment and $1,100 within the Life
Science segment. In fiscal 2019, the unfavorable effect on net revenues totaled $2,200; $1,150 within the Diagnostics segment and $1,050 within the Life
Science segment.
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Environmental
We are in compliance with applicable portions of the federal and state hazardous waste regulations and have never been a party to any environmental
proceeding.
Human Capital
As of September 30, 2021, our Diagnostics segment had approximately 560 employees in ten countries, our Life Science segment had approximately 200
employees in seven countries, and Corporate had five employees, all in the U.S. Approximately 55% of our employees are women. In addition, of our U.S.
based employees, which represents approximately 60% of our total worldwide workforce, approximately 25% are ethnically diverse.
Below is additional demographic information about our current employee base as of September 30, 2021.
Meridian Employees
2021
Salaried workforce
543
Managers and above
159
Part-time employees
27
Average age
43
Average length of service in years
7
Employee turnover rate (voluntary)
19%
Fiscal 2021 net revenues per employee (in thousands)
$415
Equal Employment Opportunity Table (by number of employees)
U.S. Employee Diversity as of September 30, 2021
Job category
Gender White
Black/African
American
Hispanic/Latino Asian
American
Indian/Alaskan
Native
Two
or
more
races
Total
Executive/senior level officials and managers
Male
12
—
— —
— — 12
Female
3
—
1 —
— —
4
First/mid-level officials and managers
Male
41
4
2
3
— — 50
Female
36
4
—
4
—
1 45
Professionals
Male
60
4
4
5
—
1 74
Female
71
9
5
9
—
2 96
All other
Male
59
11
8
5
—
1 84
Female
83
18
7
8
—
2 118
Total
Male 172
19
14
13
—
2 220
Female 193
31
13
21
—
5 263
We believe that developing a diverse, equitable and inclusive culture is critical to continuing to attract and retain the top talent necessary to deliver on our
growth strategy. As such, we continue to invest in the creation of a work environment where our employees can feel inspired to deliver their workplace best
every day. We continue to expand our Human Resources Information System (“HRIS”) and other systems to track key human capital metrics, including
workforce demographics, diversity, turnover, engagement, and training data.
Diversity, Equity and Inclusion
In 2020, we initiated the “One Meridian Inclusion Diversity and Equity Team,” which is comprised of a group of employees around the world and led by
Dr. Lourdes Weltzien, Executive Vice President, Life Science. This team has developed a mission statement and promotes awareness so we can encourage
and support an environment in which all employees feel included and empowered to achieve their best.
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Compensation and Benefits
We strive to provide pay, benefits, and services that are competitive to market and create incentives to attract and retain employees globally. Our
compensation packages include market-competitive pay, cash bonuses, health care and retirement benefits, paid time off, and family leave, among others,
depending upon locale. We are focused on pay equity globally and are striving to close the gap in pay among similar roles and responsibilities in certain
locations within our organization, after accounting for legitimate business factors that can explain differences, such as performance, time at grade level, and
tenure. We intend to conduct market surveys every two years to assess market compensation levels from a total compensation perspective. We also continue
to advance transparency in our pay and representation data by complying with all applicable statutory filing requirements.
Communication and Engagement
We strongly believe that Meridian’s success depends on employees understanding how their work contributes to the Company’s overall strategy. To this
end, we utilize a variety of channels to facilitate open and direct communication, including: (i) One Meridian Company-wide intranet; (ii) quarterly CEO
update videos; (iii) open forums or town hall meetings with executives; (iv) regular ongoing update communications; and (v) employee engagement
surveys.
Health, Wellness and Safety
We are committed to the safety of our employees and communities, from operations to product development to supplier partnerships. Our ultimate goal is to
achieve zero serious injuries through continued investment in, and focus on, our core safety programs and injury-reduction initiatives. We provide access to
a variety of innovative, flexible, and convenient health and wellness tools.
ITEM 1A.
RISK FACTORS
In addition to the other information set forth in this report, you should carefully consider the following factors, which could materially affect our business,
financial condition, cash flows or future results. Any one of these factors could cause our actual results to vary materially from recent results or from
anticipated future results. The risks described below are not the only risks facing our company. Additional risks and uncertainties not currently known to us,
or that we currently deem to be immaterial, also may materially adversely affect our business, financial condition and/or operating results.
Risk Factors Summary
Risks Related to Our Strategy
•
Our financial condition, results of operations and cash flows could be adversely affected by the ongoing and evolving COVID-19 pandemic.
•
Net revenues for our Diagnostics segment may be impacted by our reliance upon large customers in North America, seasonal factors and
sporadic outbreaks, and changing diagnostic market conditions.
•
Net revenues for our Life Science segment may be impacted by customer concentrations and buying patterns.
•
Intense competition could adversely affect our profitability and operating results.
•
We expect to continue to face increased competition resulting from the expiration of our H. pylori patents.
Risks Related to our Intellectual Property
•
We may be unable to protect or obtain adequate patent protection for intellectual property that we utilize or intend to utilize.
•
Product infringement claims by other companies could result in costly disputes and could limit our ability to sell our products.
Risks Related to our Operations
•
We may be unable to develop new products or acquire products on favorable terms.
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•
We may be unable to successfully integrate operations or to achieve expected cost savings from acquisitions we make.
•
The effective tax rate of the Company may be negatively impacted by changes in the mix of earnings as well as future changes to tax laws in
global jurisdictions in which we operate.
•
Significant interruptions in production at our principal manufacturing facilities and/or third-party manufacturing facilities could adversely
affect our business and operating results.
•
We depend on sole-source suppliers for certain critical raw materials, components and finished products. A supply interruption could
adversely affect our business.
•
Our ability to meet future customer demand for selected products is dependent upon our ability to successfully manage our manufacturing
capacity and supply chains.
•
Increased prices for, poor quality of, or extended inability to source raw materials or services used in our products, and supply chain
disruptions, could adversely affect profitability.
Risks Related to Legal, Regulatory and International Matters
•
We are subject to comprehensive regulation, and our ability to earn profits may be restricted by these regulations.
•
If we or our third-party vendors fail to comply with FDA regulations relating to the manufacturing of our products or any component part, we
may be subject to fines, injunctions and penalties, and our ability to commercially distribute and sell our products may be negatively impacted.
•
We incur costs and demands upon management as a result of complying with the laws and regulations affecting public companies in the U.S.,
and failure to comply with these laws could harm our business and the price of our common stock.
•
We could be adversely affected by health care reform legislation.
•
Efforts to reduce the U.S. federal deficit could adversely affect our results of operations.
•
Global market, political, environmental, and economic conditions, including those related to the financial markets, could have a material
adverse effect on our operating results, financial condition, and liquidity.
•
We depend on international net revenues, and our operating results may be adversely impacted by foreign currency, regulatory or other
developments affecting international markets.
•
New tariffs and other trade measures could adversely affect our operating results.
•
If product liability lawsuits are successfully brought against us, we may incur substantial liabilities and may have to limit or cease sales of our
products.
Risks Related to Our Common Stock
•
The market price of our common stock may be volatile and fluctuate significantly, which could result in substantial losses for stockholders
and subject us to litigation.
•
Our business could be negatively impacted as a result of shareholder activism, an unsolicited takeover proposal or a proxy contest.
•
The authority of our board to issue preferred stock and the effects of certain provisions of Ohio corporation law may discourage takeover bids.
General Risk Factors
•
One or more cybersecurity incidents may adversely impact our financial condition, results of operations and reputation.
•
Our business could be negatively affected if we are unable to attract, hire and retain key personnel.
•
Our bank credit agreement imposes restrictions with respect to our operations, which could adversely impact our business.
Risks Related to Our Strategy
Our financial condition, results of operations and cash flows could be adversely affected by the ongoing and evolving COVID-19 pandemic.
Any outbreak of contagious diseases, such as COVID-19, or other adverse public health developments, could have material and adverse effects on our
business operations. Such adverse effects could include diversion or prioritization of health care resources away from the conduct of diagnostic testing,
disruptions of or restrictions on the ability of laboratories to process our tests, and delays with respect to or difficulties in patients accessing our tests,
including those resulting from an inability to travel as a result of quarantines or other restrictions resulting from COVID-19. As COVID-19 continues to
affect individuals and businesses around the globe, we may experience disruptions that could severely impact our business, including:
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•
decreased volume of testing and related sales of certain of our Diagnostics segment products as a result of disruptions to health care providers
and limitations on the ability of providers to administer tests;
•
disruptions or restrictions on the ability of the Company’s, our collaborators’, or our suppliers’ personnel to travel, and temporary closures of
our facilities, or the facilities of our collaborators or suppliers;
•
limitations on employee resources that would otherwise be focused on the development of our products, the processing of our diagnostic tests,
and/or the conduct of our clinical trials, because of illness of employees or their families, or requirements imposed on employees to avoid
contact with large groups of people; and
•
delays in necessary interactions with local regulators, ethics committees, and other important agencies and contractors due to limitations in
employee resources or forced furlough of government employees.
In addition, the continued spread of COVID-19 globally could adversely affect our manufacturing and supply chains. Parts of our direct and indirect supply
chains are located overseas, including in China, and may accordingly be subject to disruption. Additionally, our results of operations could be adversely
affected to the extent that COVID-19 or any other epidemic harms our business or the economy in general either domestically or in any other region in
which we do business. The extent to which COVID-19 affects our operations will depend on future developments, which are highly uncertain and cannot be
predicted with confidence, including the duration of the outbreak, new information that may emerge concerning the severity of COVID-19, and the actions
to contain COVID-19 or treat its impact, among others, which could have an adverse effect on our business, results of operations and financial condition.
Over the course of the COVID-19 pandemic, we have generally seen a slowing of our assay instrument placements and sales of related test kits, as
diagnostic testing sites turned their attention to critical care testing. We are unable to predict when expected sales volume levels for our instruments and
related test kits will return. Also, as a result of the COVID-19 pandemic, certain clinical trials related to our products which were underway or scheduled to
begin have been temporarily placed on hold. Such delays will impact our timing for filing applications for product clearances with the FDA, as well as
related timing of FDA clearances of such filings. Additionally, the COVID-19 pandemic could slow down our efforts to expand our product portfolio
through acquisition opportunities, impacting the speed with which we are able to bring additional products to market.
Net revenues for our Diagnostics segment may be impacted by our reliance upon large customers in North America, seasonal factors and sporadic
outbreaks, and changing diagnostic market conditions.
Key Distributors
Our Diagnostics segment’s net revenues from sales through three customers, including two key distributors, were approximately 33%, 32% and 31% of the
Diagnostics segment’s total net revenues for 2021, 2020 and 2019, respectively, or approximately 13%, 15% and 21%, respectively, of each year’s
consolidated net revenues. The loss of any one of these customers could negatively impact our net revenues and results of operations unless suitable
alternatives were timely found or in the case of distributor customers, lost sales to one distributor were absorbed by another distributor. Finding a suitable
alternative on satisfactory terms may pose challenges in our industry’s competitive environment. As an alternative, we could expand our efforts to distribute
and market our products directly. This alternative, however, would require substantial investment in additional sales, marketing and logistics resources,
including hiring additional sales and customer service personnel, which would significantly increase our future selling, general and administrative expenses.
In addition, buying patterns of these customers may fluctuate from quarter to quarter, potentially leading to uneven concentration levels on a quarterly basis.
Seasonal Factors and Sporadic Outbreaks
Our principal business is the sale of a broad range of diagnostic test kits for common gastrointestinal and respiratory infectious diseases, and elevated blood
lead levels. Certain infectious diseases may be seasonal in nature, while others may be associated with sporadic outbreaks, such as foodborne illnesses or
pandemics such as an influenza outbreak or the COVID-19 pandemic. While we believe that the breadth of our Diagnostics segment product lines normally
reduces the risk that infections subject to seasonality and sporadic outbreaks will cause significant variability in Diagnostics segment net revenues, the
COVID-19 pandemic has had a significant adverse impact on our Diagnostics segment net revenues since it began in fiscal 2020. Accordingly, we can make
no assurance that net revenues will not be negatively impacted period over period by such factors.
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Changing Diagnostic Market Conditions
Changes in the U.S. health care delivery system have resulted in consolidation among reference laboratories, hospital laboratories being operated by large
reference laboratories, and the formation of multi-hospital alliances, reducing the number of institutional customers for diagnostic test products.
Consolidation in the U.S. health care industry has also led to the creation of group purchasing organizations (“GPOs”) and IDNs that aggregate buying
power for hospital groups and put pressure on our selling prices. Due to such consolidation, we may not be able to enter into and/or sustain contractual or
other marketing or distribution arrangements on a satisfactory commercial basis with institutional customers, GPOs and/or IDNs, which could adversely
affect our results of operations.
Net revenues for our Life Science segment may be impacted by customer concentrations and buying patterns.
Our Life Science segment’s net revenues from three diagnostic manufacturing customers were 22%, 30% and 27% of the Life Science segment’s total net
revenues for 2021, 2020 and 2019, respectively. Sales to these three diagnostic manufacturing customers comprised 13%, 16% and 9% of consolidated net
revenues for 2021, 2020 and 2019, respectively. In addition, in excess of 10% of the Life Science segment’s total net revenues has historically been
concentrated among a number of other significant customers. Any significant alteration of buying patterns from these customers resulting from the decline
in COVID-19 related demand, or otherwise, could adversely affect our period over period net revenues and results of operations.
Intense competition could adversely affect our profitability and operating results.
The markets for our products and services are characterized by substantial competition and rapid change. Hundreds of companies around the world supply
diagnostic tests and immunoassay and molecular reagents. These companies range from multinational health care entities, for which diagnostics is one line
of business, to small start-up companies. Many of our competitors have significantly greater financial, technical, manufacturing and marketing resources
than we do. We cannot provide assurance that our products and services will be able to compete successfully with the products and services of our
competitors.
We expect to continue to face increased competition resulting from the expiration of our H. pylori patents.
The patents for our stool antigen H. pylori products, owned by us, expired in May 2016 in the U.S. and in May 2017 in countries outside the U.S. As a
result, competition with respect to our stool antigen H. pylori products, high margin products which represent approximately 7% of our total net revenues
has increased, adversely impacting our selling prices for these products, and/or our ability to retain business at prices acceptable to us. To mitigate certain of
the pricing and volume pressures we face within the gastrointestinal product category, we have: (i) operated under a strategic collaboration agreement with
DiaSorin to sell H. pylori tests; (ii) adjusted selling prices to secure volume; and (iii) upon FDA clearance in March 2020, launched 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 BreathID and
BreathTek products to mitigate competitive pressures, as these systems provide an alternative non-invasive option to stool antigen testing. 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 net revenues and gross profit.
Risks Related to Our Intellectual Property
We may be unable to protect or obtain adequate patent protection for intellectual property that we utilize or intend to utilize.
In developing and manufacturing our products, we employ a variety of proprietary and patented technologies. In addition, we have licensed, and expect to
continue to license, various complementary technologies and methods from academic institutions and public and private companies. We cannot provide
assurance that the technologies that we own or license provide protection from competitive threats or from challenges to our intellectual property. In
addition, we cannot provide assurances that we will be successful in obtaining and retaining licenses, or proprietary or patented technologies, in the future.
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Product infringement claims by other companies could result in costly disputes and could limit our ability to sell our products.
Litigation over intellectual property rights is prevalent in the life science and diagnostic industries. As the market for diagnostics continues to grow and the
number of participants in the market increases, we may increasingly be subject to patent infringement claims. It is possible that a third party may claim
infringement against us. If found to infringe, we may attempt to obtain a license to such intellectual property; however, we may be unable to do so on
favorable terms, or at all. Additionally, if our products are found to infringe on third-party intellectual property, we may be required to pay damages for past
infringement and lose the ability to sell certain products, causing our revenues to decrease. Any substantial loss resulting from such a claim could have a
material adverse effect on our profitability, and the damage to our reputation in the industry could have a material adverse effect on our future results of
operations and liquidity, including net revenues and gross profit.
Risks Related to Our Operations
We may be unable to develop new products or acquire products on favorable terms.
The medical diagnostic and life science industries are characterized by ongoing technological developments and changing customer requirements. As such,
our results of operations and continued growth depend, in part, on our ability in a timely manner to develop or acquire rights to, and successfully introduce
into the marketplace, enhancements of existing products and services, or new products and services that incorporate technological advances, meet customer
requirements, and/or respond to products developed by our competition. We cannot provide any assurance that we will be successful in developing or
acquiring such rights to products and services on a timely basis, or that such products and services will adequately address the changing needs of the
marketplace, either of which could adversely affect our results of operations.
In addition, we must regularly allocate considerable resources to research and development of new or acquired products, services and technologies, and
protecting intellectual property. The research and development process generally takes a significant amount of time from research to product launch. This
process is conducted in various stages. During each stage, there is a risk that we will not achieve our goals on a timely basis, or at all, and we may have to
abandon a project in which we have invested substantial resources, any of which could adversely affect our results of operations.
We may be unable to successfully integrate operations or to achieve expected cost savings from acquisitions we make.
One of our growth strategies is the acquisition of companies and/or products. Although additional acquisitions of companies and products may enhance the
opportunity to increase net earnings over time, such acquisitions could result in greater administrative burdens, increased exposure to the uncertainties
inherent in marketing new products, financial risks of additional operating costs, disrupted operations, challenges in employee retention, and increased risk
of asset impairments if future net revenues and cash flows are deficient. The principal benefits expected to result from any acquisitions we make will not be
achieved fully unless we are able to successfully integrate the operations of the acquired entities with our operations and realize the anticipated synergies,
cost savings and growth opportunities from integrating these businesses into our existing businesses. We cannot provide assurance that we will be able to
identify and complete additional acquisitions on terms we consider favorable or that, if completed, will be successfully integrated into our operations.
Furthermore, we cannot predict the outcome of goodwill impairment testing and the impact of goodwill impairments on the Company’s net earnings and
results of operations.
The effective tax rate of the Company may be negatively impacted by changes in the mix of earnings as well as future changes to tax laws in global
jurisdictions in which we operate.
We are subject to income taxes in the U.S. and various other global jurisdictions. Our effective tax rate could be adversely affected by changes in the mix of
earnings by jurisdiction and the valuation of deferred tax assets and liabilities. Recently, the current U.S. presidential administration committed to tax
reform, and if enacted, the impact could be material to our tax provision and value of deferred tax assets and liabilities. We recognize deferred tax assets and
liabilities based on the differences between the consolidated financial statement carrying amounts and the tax basis of assets and liabilities. Significant
judgment is required in determining our provision for income taxes. We regularly review our deferred tax assets for recoverability and establish a valuation
allowance if it is more likely than not that some portion or all of a deferred tax asset will not be realized. If we are unable to generate sufficient future
taxable income, if there is a material change in the actual effective tax rates, or if there is a change to the time period within which the underlying temporary
differences become taxable or deductible, we could be required to increase our valuation allowance against our deferred tax assets, which could result in a
material increase in our effective tax rate.
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Changes in tax laws or tax rulings could have a material impact on our effective tax rate. Many countries in the EU, as well as several other countries and
organizations such as the Organization for Economic Cooperation and Development, are actively considering changes to existing tax laws. Certain
proposals could include recommendations that could increase our tax obligations in those countries where we do business. Any changes in the taxation of
our activities in such jurisdictions may result in a material increase in our effective tax rate.
Significant interruptions in production at our principal manufacturing facilities and/or third-party manufacturing facilities would adversely affect our
business and operating results.
Products and services manufactured at facilities we own or lease comprised a majority of our net revenues. Our global supply of these products and services
is dependent on the uninterrupted and efficient operation of these facilities. In addition, we currently rely on a small number of third-party manufacturers to
produce certain of our diagnostic products and product components. The operations of our facilities or these third-party manufacturing facilities could be
adversely affected by power failures, or natural or other disasters such as earthquakes, floods, tornadoes or terrorist threats. Although we carry insurance to
protect against certain business interruptions at our facilities, there can be no assurance that such coverage will be adequate or that such coverage will
continue to remain available on acceptable terms, if at all. Any significant interruption in the Company’s or a third-party supplier’s manufacturing
capabilities, including interruptions that have resulted from product recall activities like those currently being experienced in our Billerica facility (see
“Lead Testing Matters” beginning on page 29 within MD&A) could materially and adversely affect our results of operations.
We depend on sole-source suppliers for certain critical raw materials, components and finished products. A supply interruption could adversely affect
our business.
Raw Materials and Components
Our diagnostic products are made from a wide variety of raw materials that are biological or chemical in nature, and that generally are available from
multiple sources of supply. We sole-source certain raw materials and components, which makes it time consuming and costly to switch raw materials and
components in FDA-cleared products. If certain suppliers fail to supply required raw materials or components, we will need to secure other sources which
may require us to conduct additional development and testing and obtain regulatory approval. These activities require significant time and resources, and
there is no assurance that new sources will be secured or regulatory approvals, if necessary, will be obtained.
We utilize third-party manufacturers for certain of our instrumentation. One third party manufactures our proprietary Alethia Incubator/Reader (instrument),
a component of our Alethia molecular system, and an additional third party manufactures our Curian instrument. These instruments are manufactured
exclusively for Meridian according to our specifications. While other manufacturers for these types of instruments are available, we source each instrument
solely from one manufacturer to limit the costs involved in clearing the system for marketing in the U.S. If these third-party manufacturers fail to supply us
with instruments, we will need to secure another manufacturer, and it may take as long as 12 months to transfer instrument manufacturing. An interruption
in the manufacturing of these instruments could have a material adverse effect on our results of operations.
Additionally, one third party manufactures a certain reagent for use with our Alethia assays. While alternative suppliers exist, we elect to utilize this third
party exclusively in order to maintain consistency in our materials, which is critical in complying with FDA regulatory requirements. An interruption in the
manufacturing of these reagents could have a material adverse effect on our results of operations.
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Finished Products
We outsource the manufacturing for certain finished diagnostic products to third parties. A disruption in the supply of these finished products could have a
material adverse effect on our business until we find another supplier or bring manufacturing in-house.
Four products manufactured exclusively for us by two separate and independent companies accounted for 6%, 7% and 11% of consolidated net revenues in
2021, 2020 and 2019, respectively. Meridian owns all rights and title to the FDA 510(k) clearances for these products.
Activities undertaken by Meridian to reduce the risk of these sole-supplier arrangements include maintaining adequate inventory levels, supplier
qualification procedures, supplier audits, site visits, and frequent communication. Additionally, we have identified potential alternate suppliers.
Our ability to meet future customer demand for selected products is dependent upon our ability to successfully manage our manufacturing capacity and
supply chains.
To manage our anticipated future growth effectively, it may become necessary for us to enhance our manufacturing and supply chain capabilities,
infrastructure and operations, information technology infrastructure, and financial and accounting systems and controls. Organizational growth and
scale-up of operations could strain our existing managerial, operational, financial, and other resources. If our management is unable to effectively prepare
for our expected future growth, our expenses may increase more than anticipated, our net revenues could grow more slowly than expected, and we may not
be able to achieve our commercialization, profitability, or product development goals. Our failure to effectively implement the necessary processes and
procedures and otherwise prepare for our anticipated growth could have a material adverse effect on our future consolidated financial condition and results
of operations.
Increased prices for, poor quality of, or extended inability to source raw materials or services used in our products, and supply chain disruptions, could
adversely affect profitability.
Our profitability is affected by the prices of the raw materials used in the manufacture of our products. These prices fluctuate based on a number of factors
beyond our control, including changes in supply and demand, general economic conditions, labor costs, fuel-related delivery costs, competition, import
duties, tariffs, currency exchange rates, and, in some cases, government regulation. Significant increases in the prices of raw materials, similar to the
inflationary increases we have experienced in the second half of 2021, that cannot be recovered through increases in the price of our products and/or offset
by savings in other areas, could adversely affect our results of operations and cash flows.
We cannot guarantee that the prices we are paying for raw materials today will continue in the future, or that the marketplace will continue to support
current prices for our products, or that such prices can be adjusted to fully or partially offset raw material price increases in the future. Any increases in
prices resulting from a tightening supply of these or other commodities could adversely affect our profitability. We do not engage in hedging transactions
for raw material purchases, but we do enter into some fixed-price supply contracts.
Our dependency upon regular deliveries of supplies and the quality of those supplies upon delivery from particular suppliers means that interruptions,
stoppages, or deterioration of quality in such deliveries could adversely affect our operations until arrangements with alternate suppliers could be made.
Several of the raw materials used in the manufacture of our products currently are procured from a single source. In some cases, we also outsource certain
services to suppliers, including but not limited to, engineering, assembly, shipping, and commissioning services. If a supplier were unable to deliver these
materials or services, or if the quality of these materials or services declined, for an extended period of time as a result of financial difficulties, catastrophic
events affecting their facilities, or other factors, including recent supply chain disruptions we have experienced, or if we were unable to negotiate acceptable
terms for the supply of materials or services with these suppliers, our business could be adversely affected. We may not be able to find acceptable
alternatives, and any such alternatives could result in increased costs. Extended inability to source a necessary raw material or service could cause us to
cease manufacturing one or more products for a period of time, which could also lead to loss of customers, as well as reputational, competitive, or business
harm, which could have a material adverse effect on our business, consolidated financial condition, and results of operations.
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Risks Related to Legal, Regulatory and International Matters
We are subject to comprehensive regulation, and our ability to earn profits may be restricted by these regulations.
Medical device diagnostics is a highly regulated industry. We cannot provide assurance that we will be able to obtain necessary governmental clearances or
approvals, or timely clearances or approvals, to market future products in the U.S. and other countries. Costs and difficulties in complying with laws and
regulations administered by the FDA, the U.S. Department of Agriculture, the U.S. Department of Commerce, the U.S. Drug Enforcement Agency, the
Centers for Disease Control and Prevention (“CDC”), or other regulators can result in unanticipated expenses and delays, and interruptions to the sale of
new and existing products.
Regulatory approval can be a lengthy, expensive and uncertain process, making the timing and cost of approvals difficult to predict. Failure to comply with
these regulations can result in delays in obtaining authorization to sell products, seizure or recall of products, suspension or revocation of authority to
manufacture or sell products, and other civil or criminal sanctions.
If we or our third-party vendors fail to comply with FDA regulations relating to the manufacturing of our products or any component part, we may be
subject to fines, injunctions and penalties, and our ability to commercially distribute and sell our products may be negatively impacted.
Our diagnostics manufacturing facilities, and the manufacturing facilities of any of our third-party diagnostic component manufacturers or critical suppliers,
are required to comply with the FDA’s Quality System Regulation (“QSR”), which sets forth minimum standards for the procedures, execution and
documentation of the design, testing, production, control, quality assurance, labeling, packaging, sterilization, storage, and shipping of the products we sell,
and related regulations, including Medical Device Reporting (“MDR”) regulations regarding reporting of certain malfunctions and adverse events
potentially associated with our products. The FDA may evaluate our compliance with the QSR, MDR and other regulations, among other ways, through
periodic announced or unannounced inspections which could disrupt our operations and interrupt our manufacturing. If in conducting an inspection of our
manufacturing facilities, or the manufacturing facilities of any of our third-party component manufacturers or critical suppliers, an FDA investigator
observes conditions or practices believed to violate the QSR, the investigator may document their observations on a Form FDA 483 that is issued at the
conclusion of the inspection. A manufacturer that receives an FDA 483 may respond in writing and explain any corrective actions taken in response to the
inspectional observations. The FDA will typically review the facility’s written response and may re-inspect to determine the facility’s compliance with the
QSR and other applicable regulatory requirements. Failure to take adequate and timely corrective actions to remedy objectionable conditions listed on an
FDA 483 could result in the FDA taking administrative or enforcement actions. Among these may be the FDA’s issuance of a Warning Letter to a
manufacturer, which informs it that the FDA considers the observed violations to be of “regulatory significance” that, if not corrected, could result in further
enforcement action.
FDA enforcement actions, which include seizure, injunction, criminal prosecution, and civil penalties, could result in total or partial suspension of a
facility’s production and/or distribution, product recalls, fines, suspension of the FDA’s review of product applications, and/or the FDA’s issuance of
adverse publicity. Thus, an adverse inspection could force a shutdown of our manufacturing operations or a recall of our products. Adverse inspections
could also delay FDA approval of our products and could have an adverse effect on our production, net revenues and profitability.
We and any of our third-party vendors may also encounter other problems during manufacturing including failure to follow specific protocols and
procedures, equipment malfunction, and environmental factors, any of which could delay or impede our ability to meet demand. The manufacture of our
product also subjects us to risks that could harm our business, including problems relating to our facilities and errors in manufacturing components that
could negatively affect the efficacy or safety of our products or cause delays in shipment of our products. Any interruption or delay in the manufacture of
the product, or any of its components, could impair our ability to meet the demand of our customers and cause them to cancel orders or switch to
competitive products, which could, therefore, have a material adverse effect on our business, consolidated financial condition and results of operations.
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As described in Item 3. “Legal Proceedings”, 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. 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 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 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. The Company cannot predict when the
investigation will be resolved, the outcome of the investigation, or its potential impact on the Company. Approximately $2,803, $2,035 and $1,585 of
expense for attorneys’ fees related to this matter is included within the Consolidated Statements of Operations for the years ended September 30, 2021, 2020
and 2019, respectively.
Magellan submitted 510(k) applications in December 2018, seeking to reinstate venous blood sample-types for its LeadCare II, LeadCare Plus and
LeadCare Ultra testing systems. In February 2019 the FDA informed Magellan that each of these 510(k) applications had been put on Additional
Information hold. On July 15, 2019, we provided responses to the FDA’s requests for Additional Information. These 510(k) applications have since expired
and are no longer under FDA review. Further, while Magellan’s LeadCare testing systems remain cleared for marketing by the FDA and permitted for use
with capillary blood samples, the FDA advised that it has commissioned a third-party study of the Company’s LeadCare testing systems using both venous
and capillary blood samples. According to the FDA, the results of the field study will be used in conjunction with other information to determine whether
further action by the FDA or the CDC is necessary to protect the public health. The Company intends to fully cooperate with the FDA or CDC on any
follow-up based on the third-party study.
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. Since the inspection, we have submitted a number of written responses to the FDA regarding the five Form FDA 483 observations
issued 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).
During June 2021, the FDA performed an inspection of Magellan’s manufacturing facility. As a result of this inspection, the FDA issued one Form 483
observation. On August 3, 2021, FDA sent Magellan a close-out letter for the Warning Letter that FDA issued to Magellan on October 23, 2017. The FDA’s
close-out letter notified Magellan that FDA has completed an evaluation of Magellan’s corrective actions in response to FDA’s Warning Letter, and based
on FDA’s evaluation, Magellan has addressed the issues identified in the Warning Letter. 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.
We incur costs and demands upon management as a result of complying with the laws and regulations affecting public companies in the U.S., and
failure to comply with these laws could harm our business and the price of our common stock.
As a public company listed in the U.S., we incur significant legal, accounting and other expenses. In addition, changing laws, regulations and standards
relating to corporate governance and public disclosure, including regulations implemented by the SEC, the Public Company Accounting Oversight Board
(“PCAOB”) and the NASDAQ Global Select Market, may increase our legal and financial compliance costs and/or make some activities more time
consuming. These laws, regulations and standards are subject to varying interpretations and, as a result, their application in practice may evolve over time as
new guidance is provided by regulatory and governing bodies. We intend to invest resources to comply with evolving laws, regulations and standards, and
this investment may result in increased general and administrative expenses and a diversion of management’s time and attention from revenue-generating
activities to compliance activities. If we fail to comply with new laws, regulations and standards, regulatory authorities may initiate legal proceedings
against us, and our business may be harmed.
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We could be adversely affected by health care reform legislation.
Third-party payers for medical products and services, including state, federal and foreign governments, are increasingly concerned about escalating health
care costs and can indirectly affect the pricing or the relative attractiveness of our products by regulating the maximum amount of reimbursement they will
provide for diagnostic testing services. Following years of increasing pressure, during 2010 the U.S. government enacted comprehensive health care reform
with the enactment of the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act, which made
changes that significantly impact the pharmaceutical and medical device industries. The Protecting Access to Medicare Act of 2014 requires applicable
laboratories to report all private payor reimbursement rates and the volumes for each test they perform. The statute requires that Medicare establish
reimbursement rates based on the weighted median of private insurance reimbursement rates effective January 1, 2017. The new Medicare rates would be
subject to a maximum reduction of 10% a year for the initial three-year period and a maximum of 15% a year for the subsequent three-year period. There is
no limit on the amount of potential rate increases. As a result, some of our customers in the U.S. may experience lower Medicare reimbursement rates for
our products, which may adversely affect our business, financial condition and results of operations. We are seeing some effect on the reimbursement rates
for our products. If reimbursement amounts for diagnostic testing services decrease further in the future, such decreases may reduce the amount that will be
reimbursed to hospitals or physicians for such services and consequently, could place constraints on the levels of overall pricing, which could have a
material effect on our net revenues and results of operations.
Additional state and federal health care reform measures may be adopted in the future, any of which could have a material adverse effect on our ability to
successfully commercialize our products and on our industry in general. For example, the U.S. government has in the past considered, is currently
considering, and may in the future consider, health care policies and proposals intended to curb rising health care costs, including those that could
significantly affect both private and public reimbursement for health care services. Further, state and local governments, as well as a number of foreign
governments, are also considering or have adopted similar types of policies. Future significant changes in the health care system in the U.S. or elsewhere,
and current uncertainty about whether and how changes may be implemented, could have a negative impact on the demand for our products. We are unable
to predict whether health care policies, including policies stemming from legislation or regulations affecting our business, may be proposed or enacted in
the future, what effect such policies would have on our business, or the effect that ongoing uncertainty about these matters will have on the purchasing
decisions of our customers.
Efforts to reduce the U.S. federal deficit could adversely affect our results of operations.
Any reductions in government health care spending or research funding in an effort to reduce the U.S. federal deficit could result in reduced demand for our
products or additional pricing pressure. Further, there is ongoing uncertainty regarding the federal budget and federal spending levels, including the possible
impacts of a failure to increase the “debt ceiling.” Any U.S. government default on its debt could have broad macroeconomic effects that could, among
other things, raise our borrowing costs. Any future shutdown of the federal government or failure to enact annual appropriations could also have a material
adverse impact on our consolidated financial condition, and results of operations.
Global market, political, environmental, and economic conditions, including those related to the financial markets, could have a material adverse effect
on our operating results, financial condition, and liquidity.
Our business is sensitive to changes in general economic, political and environmental conditions, both inside and outside the U.S. Conditions such as the
following, among others, may create additional risk to our results of operations: (i) continuing uncertainties in the eurozone; (ii) the effects of climate
change regulation; (iii) the global effects of the ongoing COVID-19 pandemic, including the Emergency Temporary Standard (“ETS”) COVID-19
workplace vaccination and testing mandate from the Occupational Safety and Health Administration (“OSHA”); (iv) unanticipated implications from the
voluntary exit of the U.K. from the EU; and (v) uncertainties in China and emerging markets.
Instability in the global economy and financial markets can adversely affect our business in several ways, including limiting our customers’ ability to obtain
sufficient credit or pay for our products within the terms of sale. Competition could further intensify among the manufacturers and distributors with whom
we compete for volume and market share, resulting in lower net revenue due to steeper discounts and product mix-down. In particular, if certain key or sole
suppliers were to become capacity constrained or insolvent, it could result in a reduction or interruption in supplies or a significant increase in the price of
supplies.
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The U.K. left the 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 went 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 deals with
the EU. Although the full impact of the trade agreement is uncertain, it is possible that the recent changes to the trading relationship between the U.K. and
the EU due to the trade agreement could result in increased cost of goods imported into and exported from the U.K., which may decrease the profitability of
our operations. Additional currency volatility could drive a weaker British pound, which could increase the cost of goods imported into the U.K. and may
decrease the profitability of our operations. A weaker British pound versus the U.S. dollar may also cause local currency results of our operations to be
translated into fewer U.S. dollars during a reporting period. Given the lack of comparable precedent, it is unclear what financial, trade, regulatory and legal
implications the trade agreement will have on our business; however, Brexit and its related effects could potentially have an adverse impact on our
consolidated financial condition, and results of operations.
We depend on international net revenues, and our operating results may be adversely impacted by foreign currency, regulatory or other developments
affecting international markets.
We sell products and services into approximately 70 countries. For fiscal 2021, approximately 40% of our consolidated net revenues were transacted in
currencies other than the U.S. dollar. We are subject to the risks associated with fluctuations in the exchange rates for the Australian dollar, British pound,
Canadian dollar, Chinese yuan, Euro, and New Israeli shekel. In addition, we have manufacturing operations, suppliers, and employees located outside the
U.S. Since our growth strategy depends in part on our ability to further penetrate markets outside the U.S., we expect to continue to increase our revenue
and presence outside the U.S., including in emerging markets.
Our international business is subject to risks that are often encountered in non-U.S. operations, including:
•
interruption in the transportation of materials to us and finished goods to our customers, including conditions where recovery from natural
disasters may be delayed due to country-specific infrastructure and resources;
•
differences in terms of sale, including payment terms;
•
local product preferences and product requirements;
•
changes in a country’s or region’s political or economic condition, including with respect to safety and health issues;
•
trade protection measures and import or export licensing requirements;
•
unexpected changes in laws or regulatory requirements, including unfavorable changes with respect to tax, trade or sanctions compliance
matters;
•
limitations on ownership and on repatriation of earnings and cash;
•
difficulty in staffing and managing widespread operations;
•
differing labor regulations;
•
difficulties in enforcing contract and property rights under local law;
•
difficulties in implementing restructuring actions on a timely or comprehensive basis; and
•
differing protection of intellectual property.
Such risks may be more likely or pronounced in emerging markets, where our operations may be subject to greater uncertainty due to increased volatility
associated with the developing nature of their economic, legal, and governmental systems.
If we are unable to successfully manage the risks associated with expanding our global business or to adequately manage operational fluctuations, it could
adversely affect our business, financial condition, or results of operations.
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New tariffs and other trade measures could adversely affect our operating results.
The current U.S. administration has expressed strong concerns about imports from countries that it perceives as engaging in unfair trade practices, and it is
possible the administration could impose import duties or other restrictions on products, components or raw materials sourced from those countries, which
may include countries from which we import components or raw materials. We are currently not aware of any new import duties imposed on our products.
Any such new import duties or restrictions could have a material adverse effect on our business, results of operations or financial condition. Moreover, these
new tariffs, or other changes in U.S. trade policy, could trigger retaliatory actions by affected countries. Certain foreign governments have instituted or are
considering imposing trade sanctions on certain U.S. goods.
Other foreign governments are considering the imposition of sanctions that will deny U.S. companies access to critical raw materials. A “trade war” of this
nature or other governmental actions related to tariffs or international trade agreements or policies has the potential to adversely impact demand for our
products, our costs, customers, manufacturers, suppliers and/or the economic environments in which we operate and, thus may adversely impact our
businesses. In addition, there may be changes to existing trade agreements, like the North American Free Trade Agreement (“NAFTA”) and its anticipated
successor agreement, the U.S.-Mexico-Canada Agreement (“USMCA”), which is still subject to approval by the U.S., Mexico and Canada, greater
restrictions on free trade generally, and significant increases in tariffs on goods imported into the U.S., particularly tariffs on products manufactured in
Mexico, among other possible changes. It remains unclear what the U.S. administration or foreign governments will or will not do with respect to tariffs,
NAFTA, USMCA or other international trade agreements and policies. Any changes to NAFTA (or subsequent trade agreements) could impact our
operations in countries where we manufacture or sell products, or source components or materials, which could adversely affect our business and results of
operations.
If product liability lawsuits are successfully brought against us, we may incur substantial liabilities and may have to limit or cease sales of our products.
The testing, manufacturing and marketing of medical diagnostic products involves an inherent risk of product liability claims. If we cannot successfully
defend ourselves against product liability claims, we may incur substantial liabilities or be required to limit or cease sales of our products. We currently
carry product liability insurance at a level we believe is commercially reasonable, although there is no assurance that it will be adequate to cover claims that
may arise. In certain customer contracts, we indemnify third parties for certain product liability claims related to our products. These indemnification
obligations may cause us to pay significant sums of money for claims that are covered by these indemnifications. In addition, a defect in the design or
manufacture of our products could have a material adverse effect on our reputation in the industry and subject us to claims of liability for injury and
otherwise. Any substantial underinsured loss resulting from such a claim could have a material adverse effect on our profitability, and the damage to our
reputation in the industry could have a material adverse effect on our results of operations.
Risks Related to Our Common Stock
The market price of our common stock may be volatile and fluctuate significantly, which could result in substantial losses for stockholders and subject
us to litigation.
The market price of our common stock may be subject to significant fluctuations due to numerous factors, including but not limited to the risks described in
this “Risk Factors” section. In addition, the stock market in general, the NASDAQ Global Market and the market for diagnostics companies in particular
may experience a loss of investor confidence. A loss of investor confidence may result in extreme price and volume fluctuations in our common stock that
are unrelated or disproportionate to the operating performance of our business, financial condition or results of operations. These broad market and industry
factors may materially harm the market price of our common stock and expose us to securities class-action litigation. Class-action litigation, even if
unsuccessful, could be costly to defend and divert management’s attention and resources, which could further materially harm our consolidated financial
condition and results of operations.
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Our business could be negatively impacted as a result of shareholder activism, an unsolicited takeover proposal or a proxy contest.
In recent years, proxy contests and other forms of stockholder activism have been directed against numerous public companies. If a proxy contest or an
unsolicited takeover proposal is made with respect to us, we could incur significant costs in defending our company, which would have an adverse effect on
our financial results. Shareholder activists may also seek to involve themselves in the governance, strategic direction and operations of our company. Such
proposals may disrupt our business and divert the attention of our management and employees, and any perceived uncertainties as to our future direction
resulting from such a situation could result in the loss of potential business opportunities, be exploited by our competitors, cause concern to our current or
potential customers, and make it more difficult to attract and retain qualified personnel and business partners, all of which could adversely affect our
business. In addition, actions of activist stockholders may cause significant fluctuations in our stock price based on temporary or speculative market
perceptions or other factors that do not necessarily reflect the underlying fundamentals and prospects of our business.
The authority of our board to issue preferred stock and the effects of certain provisions of Ohio corporation law may discourage takeover bids.
Our board of directors has the authority to issue up to 1,000 shares of undesignated preferred stock and to determine the rights, preferences, privileges and
restrictions, including voting rights, of such shares without any future vote or action by the shareholders. The issuance of preferred stock under certain
circumstances could have the effect of delaying or preventing a change in control of our company. Ohio corporation law contains provisions that may
discourage takeover bids for our company that have not been negotiated with the board of directors. Such provisions could limit the price that investors
might be willing to pay in the future for shares of our common stock. In addition, sales of substantial amounts of shares in the public market could adversely
affect the market price of our common stock and our ability to raise additional capital at a price favorable to us.
General Risk Factors
One or more cybersecurity incidents may adversely impact our financial condition, results of operations and reputation.
Our operations involve the use of multiple systems that process, store and transmit sensitive information about our customers, suppliers, employees,
financial position, operating results and strategies. We face global cybersecurity risks and threats on a continual and ongoing basis, which include, but are
not limited to, attempts to access systems and information, computer viruses, or denial-of-service attacks. These risks and threats range from uncoordinated
individual attempts to sophisticated and targeted measures. While we are not aware of any material cyber-attacks or breaches of our systems to date, we
have and continue to implement measures to safeguard our systems and information and mitigate potential risks, including employee training around
phishing, malware and other cyber risks, but there is no assurance that such actions will be sufficient to prevent cyber-attacks or security breaches that
manipulate or improperly use our systems, compromise sensitive information, destroy or corrupt data, or otherwise disrupt our operations. The occurrence
of such events, including breaches of our security measures or those of our third-party service providers, could negatively impact our reputation and our
competitive position and could result in litigation with third parties, regulatory action, loss of business due to disruption of operations and/or reputational
damage, potential liability and increased remediation and protection costs, any of which could have a material adverse effect on our consolidated financial
condition and results of operations. In an effort to mitigate the financial impact such an attack might have on the Company, we maintain cyber liability
insurance coverage. However, such coverage may be insufficient to cover the full impact of a cyber-attack. Additionally, as cybersecurity risks become
more sophisticated, we may need to increase our investments in security measures which could have a material adverse effect on our consolidated financial
condition and results of operations.
Our business could be negatively affected if we are unable to attract, hire and retain key personnel.
Our future success depends on our continued ability to attract, hire and retain highly qualified personnel, including our executive officers and scientific,
technical, sales and marketing employees, and their ability to manage growth successfully. If such key employees were to leave and we were unable to
obtain adequate replacements, our results of operations could be adversely affected.
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Our bank credit agreement imposes restrictions with respect to our operations, which could adversely impact our business.
Our bank credit agreement contains a number of financial covenants that require us to meet certain financial ratios and tests. If we fail to comply with the
obligations in the credit agreement, we would be in default under the credit agreement. If an event of default is not cured or waived, it could result in
acceleration of any indebtedness under our credit agreement, which could have a material adverse effect on our business. At September 30, 2021, we had
$60,000 outstanding on a $160,000 bank revolving credit facility.
ITEM 1B.
UNRESOLVED STAFF COMMENTS
None.
ITEM 2.
PROPERTIES
Our corporate offices are located in the Village of Newtown, a suburb of Cincinnati, Ohio. Our Newtown campus includes sites for diagnostic test
manufacturing and distribution, immunoassay research and development and administrative functions. Our Newtown campus also includes a new facility
where we are expanding and automating our Revogene diagnostic test device manufacturing. We also have diagnostic test manufacturing and distribution
sites in Billerica, Massachusetts (blood-chemistry), Modi’in, Israel (BreathID and BreathTek urea breath testing systems), and Quebec City, Quebec,
Canada (Revogene diagnostic test device and instrument manufacturing). Our sites in Billerica, Modi’in and Quebec City also include research and
development functions. We also operate a Diagnostics sales and distribution center near Milan, Italy and rent office space in Paris, France and
Braine-l’Alleud, Belgium for sales and administrative functions, and space in Manasquan, New Jersey and Changzhou, China to house BreathID technical
service and repair functions.
Our Life Science operations are conducted in several facilities in Memphis, Tennessee; Boca Raton, Florida; London, England; Luckenwalde, Germany;
Sydney, Australia; and Beijing, China. Manufacturing of molecular reagents occurs in our London and Luckenwalde sites. Manufacturing of immunoassay
reagents occurs in our Memphis and Boca Raton sites. Our site in London also includes our primary research and development function.
ITEM 3.
LEGAL PROCEEDINGS
We are a party to various litigation matters that we believe are in the normal course of business. Aside from the matters discussed below, the ultimate
resolution of these matters is not expected to have a material adverse effect on our consolidated financial position, results of operations or cash flows, and
no material provision has been made in the Consolidated Financial Statements for these matters.
On April 17, 2018, the Company’s wholly owned subsidiary Magellan received a subpoena from the 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 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 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. The Company cannot predict when the investigation will be resolved, the outcome of the investigation, or its potential impact
on the Company. Approximately $2,803, $2,035 and $1,585 of expense for attorneys’ fees related to this matter is included within the Consolidated
Statements of Operations for 2021, 2020 and 2019, respectively. See “Lead Testing Matters” beginning on page 29 within MD&A.
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ITEM 4.
MINE SAFETY DISCLOSURES
Not applicable.
PART II.
ITEM 5.
MARKET FOR REGISTRANT’S COMMON
EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES
Market Information
Our common stock trades on the NASDAQ Global Select Market under the symbol VIVO.
Holders of our Common Stock
As of September 30, 2021, there were approximately 550 holders of record and approximately 24,030 beneficial owners of our common shares.
Dividends
During 2019, the Company suspended the payment of its quarterly cash dividend, which had previously been established at an indicated annual cash
dividend rate of $0.50 per share for fiscal 2019. The dividend was suspended as part of the Company’s regular evaluation of its capital allocation, with the
action taken in order to deploy cash into new product development activities and to preserve capital resources and liquidity for general corporate purposes.
Any declaration and amount of dividends will be determined by the board of directors in its discretion based upon its evaluation of earnings, cash flow
requirements, business developments and opportunities, and any other factors the board of directors determines are relevant to its evaluation. At this time,
we do not expect to resume paying cash dividends. We paid dividends of $0.25 per common share in 2019.
Stock Total Return Performance
The graph below compares the cumulative 5-Year total return realized by shareholders on Meridian Bioscience, Inc.’s common stock relative to the
cumulative total returns of the NASDAQ Composite index and two customized peer groups of six companies and ten companies, respectively, whose
individual companies are listed in footnotes 1 and 2 below. An investment of $100 (with reinvestment of all dividends) is assumed to have been made in our
common stock, in the index and in each of the peer groups (including reinvestment of dividends) on September 30, 2016, and its relative performance is
tracked through September 30, 2021.
1.
The six companies included in the Company’s first customized peer group (“2020 Peer Group”) are: Bio-Rad Laboratories, Inc.,
bioMerieux S.A., Myriad Genetics, Inc., OraSure Technologies, Inc., Quidel Corporation, and Trinity Biotech Plc.
2.
The ten companies included in the Company’s second customized peer group (“2021 Peer Group”) are: Bio-Rad Laboratories, Inc.,
Bio-Techne Corporation, bioMerieux S.A., DiaSorin S.p.a., Hologic, Inc., Myriad Genetics, Inc., OraSure Technologies, Inc., Qiagen
N.V., Quidel Corporation, and Trinity Biotech Plc.
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ITEM 6.
INTENTIONALLY OMITTED
ITEM 7.
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL
CONDITION AND RESULTS OF OPERATIONS
Refer to “Note About Forward-Looking Statements” following the Index in front of this Form 10-K and Item 1A “Risk Factors” on pages 11 through 24 of
this Annual Report.
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 consolidated financial
condition and results of operations of Meridian Bioscience, Inc. (“Meridian”, the “Company”, “We”). This discussion should be read in conjunction with
the 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.
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Our reportable segments are Diagnostics and Life Science. The Diagnostics segment consists of manufacturing operations for infectious disease products in
Cincinnati, Ohio; Quebec City, Canada; and Modi’in, Israel; and manufacturing operations for blood chemistry products in Billerica, Massachusetts (near
Boston). These diagnostic test products are sold and distributed in the countries comprising North and Latin America (the “Americas”); Europe, Middle
East and Africa (“EMEA”); and other countries outside of the Americas and EMEA (rest of the world, or “ROW”). The Life Science segment consists of
manufacturing operations in Memphis, Tennessee; Boca Raton, Florida; London, England; and Luckenwalde, Germany, and the sale and distribution of
bulk antigens, antibodies, immunoassay blocking reagents, specialized Polymerase Chain Reaction (“PCR”) master mixes, isothermal mixes, enzymes,
nucleotides, and bioresearch reagents domestically and abroad, including a sales and business development facility, with outsourced distribution
capabilities, in Beijing, China to further pursue growing revenue opportunities in Asia.
Recent Developments
Impact of COVID-19 Pandemic
During the latter half of fiscal 2020 and throughout fiscal 2021, the COVID-19 pandemic has had both positive and negative effects on our business.
Our Life Science segment’s products have been well positioned to respond to in vitro device (“IVD”) manufacturers’ needs for reagents for molecular, rapid
antigen and serology tests. Consequently, our Life Science segment grew its revenues over 100% in fiscal 2020 and delivered record operating income and
margin, demonstrating what this segment could achieve at a much larger scale. This higher-than-historical level of growth in the Life Science segment
continued in fiscal 2021, with full year revenues, operating income and operating margin increasing 43%, 67% and nine percentage points, respectively.
Our Diagnostics segment, on the other hand, has been negatively impacted by the health systems’ increased focus on COVID-19 testing over traditional
infectious disease testing. The 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 being experienced in fiscal 2020.
Despite these recent COVID-19 pandemic related trends, 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 consolidated financial condition of the ongoing COVID-19 pandemic.
Employee Safety
While our employee base in the U.S. has returned to working on-site at our facilities, we have recently implemented a hybrid work-from-home program for
certain personnel, and we continue to utilize a work-from-home process as needed on a site-by-site basis outside the U.S. for those employees whose
on-site presence has been deemed to be non-essential. We have also implemented enhanced cleaning and sanitizing procedures and provided additional
personal hygiene supplies at all our sites. We have implemented policies for employees to adhere to Centers for Disease Control and Prevention (“CDC”)
guidelines on social distancing, and similar guidelines by authorities outside the U.S. To date, we have been able to manufacture and distribute products
globally, and all our sites have 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 have generally remained intact, providing access to sufficient inventory of the key materials needed for
manufacturing. To date, delays and allocations for raw materials have been limited and have not had a material impact on our results of operations. From
time to time, we identify alternative suppliers to address the risk of a current supplier’s inability to deliver materials in volumes sufficient to meet our
manufacturing needs; or we may choose to purchase 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. See LeadCare product recall discussion beginning on page 29.
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Product Development and Clinical Trials
Our Diagnostics segment’s new product development programs are progressing at a slower pace than normal, in part, as the prevalence of certain infectious
diseases has been much lower than normal during the COVID-19 pandemic. For example, the relative lack of a respiratory illness season in 2020-2021 has
significantly impacted the availability of influenza samples, thereby affecting the pace of development of our molecular respiratory panel for the Revogene
system. These matters continue to impact our timing for filing applications for product clearances with the 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 and distribution opportunities, impacting the speed with which we are able to bring additional
products to market.
Product Demand
Our Life Science segment manufactures, markets and sells a number of molecular and immunological reagents to IVD customers, including those who are
making both molecular and immunoassay COVID-19 tests. Since late in the second quarter of fiscal 2020, we have generally experienced unprecedented
demand for certain of our molecular reagents (e.g., ribonucleic acid (“RNA”) master mixes and nucleotides), including a resurgence in such demand during
our fiscal 2021 fourth quarter. While we are expecting a continuation of this trend for the foreseeable future, this expectation will certainly be impacted by
infection rates and the responses to such 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 200 regulatory agency approved COVID-19 related assays around the world. COVID-19 related reagent
revenues totaled approximately $111,900 and $71,500 for the years ended September 30, 2021 and 2020, respectively.
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 and
half, as such assays are often used in non-critical care settings. However, we have seen indications of a return to more normal pre-pandemic levels,
including with respect to our respiratory illness assays during the fourth quarter of 2021. The COVID-19 pandemic also has depressed instrument orders and
placements for our BreathID, Curian and Revogene platforms. Order activity for our Revogene platform was affected by the delay in obtaining emergency
use authorization (“EUA”) for our SARS-CoV-2 assay, as we believe customers have taken a “wait and see” approach throughout our entire EUA
application process, which culminated in receipt of the EUA on November 9, 2021. This follows our voluntary withdrawal of the application on
February 23, 2021 and its resubmission on June 25, 2021. Despite the situation encountered with our EUA application for the SARS-CoV-2 assay, we have
proceeded with the process of increasing our capacity to produce these tests, as well as other tests on the Revogene system, at our facilities in Quebec and
Cincinnati. Specifically, we are: (i) adding a second production line at our Quebec manufacturing facility; and (ii) installing two additional production lines
in a leased facility near our corporate headquarters in Cincinnati. With approximately $10,900 expended in the year ended September 30, 2021, it is
expected that these expansion efforts will be completed during calendar 2021 at a total cost of approximately $19,600, which is expected to be partially
offset by the $5,500 National Institutes of Health Rapid Acceleration of Diagnostics (“RADx”) initiative grant entered into on February 1, 2021, $1,500 of
which had been received as of September 30, 2021 (see Note 14, “National Institutes of Health Contracts” of the Consolidated Financial Statements).
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 went 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 deals with the EU. Although the full impact of the trade agreement is uncertain, it is possible that the recent changes to the
trading relationship between the U.K. and the EU due to the trade agreement could result in increased cost of goods imported into and exported from the
U.K., which may decrease the profitability of our operations. Additional currency volatility could drive a weaker British pound, which could increase the
cost of goods imported into the U.K. and may decrease the profitability of our operations. A weaker British pound versus the U.S. dollar may also cause
local currency results of our operations to be translated into fewer U.S. dollars during a reporting period. Given the lack of comparable precedent, it is
unclear what financial, trade, regulatory and legal implications the trade agreement will have on our business; however, Brexit and its related effects could
potentially have an adverse impact on our consolidated financial position and results of operations.
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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
identified areas of concern and implemented strategies to help mitigate these concerns. It is possible that these strategies may not be adequate to mitigate
any adverse impacts of Brexit, and that these impacts could further adversely affect our business and results of operations.
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. The Company is working 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. Although evaluation of the recall and the
related notification process is ongoing, approximately $5,100 has been estimated and accrued as of September 30, 2021, to cover the currently anticipated
costs of the recall. In total, approximately $5,600 of recall-related expense has been included within the Consolidated Statement of Operations for the year
ended September 30, 2021. Anticipated recall-related costs primarily include product replacement and/or refund costs, mailing/shipping costs, attorneys’
fees and other miscellaneous costs.
As described in Item 3. “Legal Proceedings”, 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. 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 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 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. The Company cannot predict when the
investigation will be resolved, the outcome of the investigation, or its potential impact on the Company. Approximately $2,803, $2,035 and $1,585 of
expense for attorneys’ fees related to this matter is included within the Consolidated Statements of Operations for the years ended September 30, 2021, 2020
and 2019, respectively.
Magellan submitted 510(k) applications in December 2018, seeking to reinstate venous blood sample-types for its LeadCare II, LeadCare Plus and
LeadCare Ultra testing systems. In the second fiscal quarter of 2019 the FDA informed Magellan that each of these 510(k) applications had been put on
Additional Information hold. On July 15, 2019, we provided responses to the FDA’s requests for Additional Information. These 510(k) applications have
since expired and are no longer under FDA review. Further, while Magellan’s LeadCare testing systems remain cleared for marketing by the FDA and
permitted for use with capillary blood samples, the FDA advised that it has commissioned a third-party study of the Company’s LeadCare testing systems
using both venous and capillary blood samples. According to the FDA, the results of the field study will be used in conjunction with other information to
determine whether further action by the FDA or the CDC is necessary to protect the public health. The Company intends to fully cooperate with the FDA or
CDC on any follow-up based on the third-party study.
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. Since the inspection, we have submitted a number of written responses to the FDA regarding the five Form FDA 483 observations
issued 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).
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During June 2021, the FDA performed an inspection of Magellan’s manufacturing facility. As a result of this inspection, the FDA issued one Form 483
observation. On August 3, 2021, FDA sent Magellan a close-out letter for the Warning Letter that FDA issued to Magellan on October 23, 2017. FDA’s
close-out letter notified Magellan that FDA has completed an evaluation of Magellan’s corrective actions in response to FDA’s Warning Letter, and based
on FDA’s evaluation, Magellan has addressed the issues identified in the Warning Letter. 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.
Results of Operations
Fourth Quarter
Net earnings for the fourth quarter of fiscal 2021 increased 3% to $6,657, or $0.15 per diluted share, from net earnings for the fourth quarter of fiscal 2020
of $6,493, or $0.15 per diluted share. The level of net earnings in the fourth quarter of fiscal 2021 was adversely affected by approximately $5,600, or $0.10
per diluted share, of LeadCare product recall expenses and a $4,596, or $0.08 per diluted share, upward adjustment to the fair value of acquisition
consideration related to GenePOC, offsetting the impact of higher revenues and resulting gross profit. Other key events occurring in the fourth quarter of
2021 include the acquisition of the BreathTek business in July 2021 and the August 2021 settlement of the contingent acquisition consideration related to
GenePOC (see Note 4, “Business Combinations” and Note 3, “Fair Value Measurements” of the Consolidated Financial Statements, respectively).
Consolidated revenues for the fourth quarter of fiscal 2021 totaled $76,204, an increase of 19% compared to the fourth quarter of fiscal 2020 (17% increase
on a constant-currency basis).
Revenues from the Diagnostics segment for the fourth quarter of fiscal 2021 increased 15% to $34,301, compared to the fourth quarter of fiscal 2020 (also
15% increase on a constant-currency basis), comprised of a 22% increase in molecular assay products and a 14% increase in non-molecular assay products.
The fourth quarter of fiscal 2021 represents the second consecutive quarter our Diagnostics segment has shown positive revenue growth versus the same
quarter of fiscal 2020, an achievement not experienced since the early stages of the COVID-19 pandemic. Our Diagnostics segment generated an $11,900
operating loss for the fourth quarter of fiscal 2021, a $7,700 larger operating loss than the fourth quarter of fiscal 2020, largely due to the aforementioned
$5,600 of LeadCare product recall expenses and $4,596 upward adjustment to the fair value of acquisition consideration related to GenePOC.
With a 16% increase in revenues from molecular reagents products and a 33% increase in revenues from immunological reagents products, revenues for our
Life Science segment increased 22% to $41,903 during the fourth quarter of fiscal 2021 compared to the fourth quarter of fiscal 2020. On a constant-
currency basis, revenues for the Life Science segment increased 19%. Life Science segment revenues reflect an increase in demand from diagnostic test
manufacturers for the reagents utilized in COVID-19 related tests. Revenue from sales of our core Life Science segment products (other than COVID-19
related contributions) experienced growth of approximately $1,800, or 11%, compared to the fourth quarter of fiscal 2020. This growth resulted in large part
from obtaining business from COVID-19 customers who are now using our products for other non-COVID-19 related purposes, as well as a rebound in
volumes of core immunological products. Our Life Science segment generated $23,200 of operating income, or a margin of 55%, for the fourth quarter of
fiscal 2021, an increase of $6,000 from the fourth quarter of fiscal 2020.
Fiscal Year
Net earnings for fiscal 2021 increased 55% to $71,407, or $1.62 per diluted share, from net earnings for fiscal 2020 of $46,186, or $1.07 per diluted share.
The level of net earnings in fiscal 2021 was affected predominantly by the strong increase in revenues and operating income in our Life Science segment,
stemming primarily from the demand for reagents used in COVID-19 related tests.
Consolidated revenues for fiscal 2021 totaled $317,896, an increase of 25% compared to fiscal 2020 (22% increase on a constant-currency basis).
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Diagnostics segment revenues increased 5% to $127,760 in fiscal 2021 (4% increase on a constant-currency basis), comprised of a 13% decrease in
molecular assay products and a 10% increase in non-molecular assay products. Our Diagnostics segment generated an $8,100 operating loss in fiscal 2021,
compared to operating income of $3,900 in fiscal 2020. This year over year decline in operating income resulted primarily from the combined effects of:
(i) lower gross profit margins, as detailed in the “Gross Profit” section below; (ii) the aforementioned $5,600 of LeadCare product recall expenses in fiscal
2021; and (iii) the $6,293 decrease in the fair value of contingent acquisition consideration related to GenePOC included in fiscal 2020 and settled in fiscal
2021 (as discussed above). These factors contributing to the decline in operating margin were partially offset by the decrease in acquisition costs resulting
from the Exalenz transaction in fiscal 2020.
With a 66% increase in revenues from molecular reagents products and a 10% increase in revenues from immunological reagents products, revenues for our
Life Science segment increased 43% to $190,136 during fiscal 2021 compared to fiscal 2020. On a constant-currency basis, revenues for the Life Science
segment increased 38%. Fiscal 2021 Life Science segment revenues reflect a significant increase in 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 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, revenue from sales of our core Life Science segment products (other than COVID-19 contributions)
experienced growth of approximately $16,100, or approximately 26%. This growth resulted in large part from obtaining business from COVID-19
customers who are now using our products for other non-COVID-19 related purposes, as well as a rebound in volumes in core immunological products. Our
Life Science segment generated $115,300 of operating income in fiscal 2021, an increase of $46,400 over fiscal 2020.
REVENUE OVERVIEW
Below are analyses of the Company’s revenue, by reportable segment, provided for each of the following:
- By 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 year to year by buying patterns of major distributors and
reference laboratories, 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 year to year by buying patterns of major IVD
manufacturing customers, severity of disease outbreaks (including the COVID-19 pandemic), and foreign currency exchange rates. The COVID-19
pandemic contributed $111,900 of new revenue for our Life Science segment during fiscal 2021, and $71,500 during fiscal 2020.
See Note 2, “Revenue Recognition” of the Consolidated Financial Statements for detailed revenue disaggregation information.
Following is a discussion of the revenues generated by these product platforms/types and/or disease states:
Diagnostics Segment Products
The Diagnostics segment’s overall 5% growth in revenue during fiscal 2021 primarily results from the combined effects of the following:
•
Volume growth in the gastrointestinal product family benefitting from: (i) a full year of revenue from sales of BreathID instruments and tests,
acquired in the April 2020 Exalenz acquisition; and (ii) two months of revenue from sales of the BreathTek product, acquired in late July
2021;
•
Ongoing pricing pressure on our H. pylori stool antigen tests, which contributed approximately $2,700 of unfavorable price variance from
customers in the U.S.;
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•
Volume declines from sales of respiratory illness products, comprised of tests for Group A Strep, Mycoplasma pneumonia, Influenza, and
Pertussis, among others, reflecting the decreased focus on testing for these illnesses throughout the COVID-19 pandemic; and
•
Volume declines from sales of blood chemistry products due to the ongoing LeadCare product recall, which commenced in May 2021 ($2,136
decrease in revenue in fiscal 2021, compared to fiscal 2020).
Life Science Segment Products
The tripling of the Life Science segment’s revenues since fiscal 2019, including the 43% year-over-year growth in revenue during fiscal 2021,
primarily results from the combined effects of the following:
•
Unprecedented demand for the Life Science segment’s products by diagnostic test manufacturers for use in COVID-19 related tests, resulting
in COVID-19-related reagent revenues totaling $111,900 in fiscal 2021, compared to approximately $71,500 in fiscal 2020; and
•
Revenue from core Life Science products increasing approximately 26% over fiscal 2020, due in large part from obtaining business from
COVID-19 customers who are now using our products for non-COVID-19 related purposes, as well as a rebound in volumes of core
immunological product sales.
Foreign Currency
Fluctuations in foreign currency exchange rates in fiscal 2021 compared to fiscal 2020 had an approximate $9,200 favorable impact on fiscal 2021
consolidated net revenues; $1,300 within the Diagnostics segment and $7,900 within the Life Science segment. This compares to year-to-year currency
exchange rates having an approximate $1,250 unfavorable impact on consolidated net revenues in fiscal 2020; $150 within the Diagnostics segment and
$1,100 within the Life Science segment.
Significant Customers
Revenue concentrations related to certain customers within our Diagnostics and Life Science segments are set forth in Note 15, “Reportable Segments and
Major Concentration Data” of the Consolidated Financial Statements.
Gross Profit:
2021
2020
2021 vs. 2020
Inc (Dec)
Gross Profit
$201,148
$156,248
29%
Gross Profit Margin
63%
62%
1 point
Overall gross profit margins during both fiscal 2021 and 2020 have been favorably impacted by greater contributions from our Life Science segment’s
molecular reagent products, which are some of our highest margin products. During fiscal 2021, which included the peak of the COVID-19 pandemic,
approximately 41% of consolidated revenues related to sales of molecular reagent products, compared to approximately 31% during fiscal 2020.
Overall gross profit margins in fiscal 2021 have been unfavorably impacted in our Diagnostics segment by production capacity ramp-up and scrap costs in
our Quebec facility, where Revogene instruments and test devices are made, inventory reserve provisions for short-dated products stemming from depressed
sales levels during the COVID-19 pandemic, and the impacts of the previously discussed LeadCare product recall (see “Lead Testing Matters” above).
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Operating Expenses — Segment Detail and Corporate
Research &
Development
Selling &
Marketing
General &
Administrative
Other (1)(2)
Total Operating
Expenses
Fiscal 2020:
Diagnostics
$
21,454
$ 21,172
$
23,233
$
(1,916)
$
63,943
Life Science
2,275
5,314
11,755
200
19,544
Corporate
—
—
9,357
2,080
11,437
Total 2020 Expenses
$
23,729
$ 26,486
$
44,345
$
364
$
94,924
Fiscal 2021:
Diagnostics
$
21,406
$ 21,430
$
24,915
$
5,079
$
72,830
Life Science
2,505
5,350
13,265
—
21,120
Corporate
—
—
11,361
2,803
14,164
Total 2021 Expenses
$
23,911
$ 26,780
$
49,541
$
7,882
$
108,114
(1)
Diagnostics segment fiscal 2020 reflects negative expense amount due to $6,293 adjustment to fair value of the acquisition consideration related to
GenePOC.
(2)
LeadCare product recall expenses are included within the Diagnostics segment’s fiscal 2021 Other expenses.
Operating expenses in fiscal 2021 increased $13,190 to $108,114. Major components of this increase were as follows:
•
$5,600 in LeadCare product recall expenses within our Diagnostics segment;
•
$1,400 increase in purchase accounting amortization within our Diagnostics segment, stemming from both the Exalenz and BreathTek
acquisitions;
•
a full year of administrative expenses within our Diagnostics segment related to the Exalenz acquisition completed in April 2020;
•
higher commercial insurance costs for Directors & Officers and Property & Casualty coverages within Corporate; and
•
the adjustment to the fair value of the acquisition consideration as the result of the settlement in fiscal 2021 resulting in a $5,384 year-over-
year increase in expense within our Diagnostics segment.
Offsetting these increases was lower spending for acquisition transaction costs, stemming from the Exalenz acquisition.
Operating Income
Operating income increased 52% in fiscal 2021, following an 88% increase in fiscal 2020, as a result of the factors discussed above.
Other Expense
Other expense, net primarily includes interest costs on the Company’s long-term borrowings and contingent grant obligations due to the Israel Innovation
Authority, currency gains and losses, and in fiscal 2021, grant income under the RADx initiative (see Note 14, “National Institutes of Health Contracts” of
the Consolidated Financial Statements). Interest costs related to the revolving credit facility with a commercial bank were $1,420 and $2,464 in fiscal 2021
and 2020, respectively. The varying levels of interest costs on the revolving credit facility reflect the following approximate levels of average debt
outstanding, as detailed in Note 10, “Bank Credit Arrangements” of the Consolidated Financial Statements: (i) fiscal 2021 - $56,505; and (ii) fiscal 2020 -
$74,560.
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Income Taxes
The effective rate for income taxes was 21% and 22% for fiscal 2021 and 2020, respectively. The decline in effective tax rates relates primarily to the
increasing allocations of taxable income in certain foreign jurisdictions with tax rates lower than the U.S., particularly the U.K. Additionally, the fiscal 2021
effective rate was favorably impacted by a larger-than-prior-year effect of current year 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.
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 cost of purchased materials and services. Inflation and changing prices did not have a material adverse impact on our gross margin,
revenues or operating income in fiscal 2021 or 2020.
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, 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 bank revolving credit facility, which totaled
$100,000 as of September 30, 2021. The Company also maintains a shelf registration statement on file with the SEC. Our liquidity needs may change if
overall economic conditions worsen and/or liquidity and credit within the financial markets tightens for an extended period, and such conditions impact the
collectability of our customer accounts receivable, impact credit terms with our vendors, or disrupt the supply of raw materials and services.
As of September 30, 2021, our cash and cash equivalents balance was $49,771 or $3,743 lower than at the end of fiscal 2020. This modest decrease
primarily results from generating $66,865 of cash flow from operations, an increase of 39% over fiscal 2020, and the use of cash to fund certain rather
significant uses of cash during the year, most notably the following:
(i)
payment of consideration holdback and contingent consideration settlement related to the fiscal 2019 GenePOC acquisition ($25,000);
(ii)
acquisition of the BreathTek business, net of $1,000 holdback ($18,585);
(iii)
funding of capital expenditures, which were primarily comprised of manufacturing expansion related to Revogene, net of $1,500 RADx
grant monies received ($16,812); and
(iv)
net paydown on revolving credit facility and Israeli government grant obligations ($8,824 and $5,297, respectively).
Considering these factors, our balance of net debt (defined as bank debt, government grant obligations and total contingent obligations related to
acquisitions, net of cash and cash equivalents on-hand) decreased approximately $36,300 to approximately $17,000 at September 30, 2021.
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Capital Resources
As described in Note 10, “Bank Credit Arrangements” of the Consolidated Financial Statements, the Company maintains a $160,000 credit facility, which
is secured by substantially all our U.S. assets and includes certain restrictive financial covenants. This credit facility was amended in October 2021 to
increase its capacity to $200,000 and extend its term to October 25, 2026. The Company also maintains a shelf registration statement on file with the SEC.
Our capital expenditures totaled $18,312 for fiscal 2021, $1,500 of which was offset by receipts under the RADx grant initiative (see Note 14, “National
Institutes of Health Contracts” of the Consolidated Financial Statements), and which largely related to expanding manufacturing capacity. During fiscal
2022 our capital expenditures are estimated to total approximately $15,000, comprised of approximately $12,000 and $3,000 in the Diagnostics and Life
Science segments, respectively. Included within the Diagnostics segment capital expenditures estimate is approximately $8,700 related to completion of the
manufacturing capacity scale-up and 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 $200,000 revolving credit facility discussed above. In addition, a portion of the
Diagnostics segment expansion may be funded by $4,000 remaining under the previously noted RADx grant entered into on February 1, 2021 (see Note 14,
“National Institutes of Health Contracts” of the Consolidated Financial Statements).
Contractual Obligations :
In addition to the obligations related to the above-noted revolving credit facility and the contingent government grant obligations detailed in Note 10, “Bank
Credit Arrangements” and Note 13, “Contingent Obligations and Non-Current Liabilities” of the Consolidated Financial Statements, respectively, the
Company’s contractual obligations and their related due dates were as follows as of September 30, 2021:
Total
Less than 1
Year
1-3 Years
4-5 Years
More than
5 Years
Operating leases (1)
$ 6,239
$
2,194
$ 2,736
$ 1,244
$
65
Purchase obligations (2)
51,295
49,537
1,554
204
—
Acquisition price holdback (3)
1,000
—
1,000
—
—
Uncertain income tax positions liability and interest (4)
870
870
—
—
—
Total
$59,404
$ 52,601
$ 5,290
$ 1,448
$
65
(1)
Meridian and its subsidiaries are parties to a number of operating lease agreements around the world, the majority of which relate to office and
warehouse building leases expiring at various dates.
(2)
Purchase obligations relate primarily to outstanding purchase orders for machinery and equipment, inventory, including instruments, service items,
and research and development activities. These contractual commitments are not in excess of expected production requirements over the next twelve
months.
(3)
Pursuant to the purchase agreement related to the July 31, 2021 acquisition of the BreathTek business, Meridian’s remaining consideration to be paid
totals $1,000 and is comprised solely of a purchase price holdback.
(4)
Due to inherent uncertainties in the timing of settlement of tax positions, we are unable to estimate the timing of the effective settlement of these
obligations.
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Other Commitments and Off-Balance Sheet Arrangements :
License Agreements
Meridian has entered into various license agreements that require payment of royalties based on a specified percentage of sales of related products, with
such percentages generally ranging from approximately 3% to 10%. During fiscal 2021, royalty expense totaled approximately $5,200, with 25% and 75%
of such expense relating to our Diagnostics and Life Science segments, respectively. This compares to a total of approximately $1,850 of royalty expense in
fiscal 2020, with 81% and 19% relating to our Diagnostics and Life Science segments, respectively. Meridian expects that payments under these agreements
will amount to approximately $3,000 in fiscal 2022.
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 3, “Fair Value Measurements” of the Consolidated Financial Statements). Aside from these instruments, we do not utilize special-purpose financing
vehicles or have any material undisclosed off-balance sheet arrangements.
Market Risk Exposure :
Foreign Currency Risk
We have market risk exposure related to foreign currency transactions from our operations outside the U.S., as well as certain suppliers to our domestic
businesses located outside the U.S. The foreign currencies where we have market risk exposure are the Australian dollar, British pound, Canadian dollar,
Chinese yuan, Euro, and New Israeli shekel. Assessing foreign currency exposures is a component of our overall ongoing risk management process, with
such currency risks managed as we deem appropriate.
Concentration of Customers/Products Risk
Our Diagnostics segment’s revenues from sales to three customers were 33% and 32% of the Diagnostics segment’s total net revenues for fiscal 2021 and
2020, respectively, or 13% and 15% of consolidated net revenues in each fiscal year. Additionally, our three major Diagnostics segment product families –
gastrointestinal, respiratory illnesses and blood chemistry – accounted for 80% and 82% of our Diagnostics segment’s net revenues during fiscal 2021 and
2020, respectively, or 32% and 39% of each year’s consolidated net revenues.
Our Life Science segment’s revenues from sales to three diagnostics manufacturing customers were 22% and 30% of the Life Science segment’s total net
revenues for fiscal 2021 and 2020, respectively or 13% and 16% of consolidated net revenues in each fiscal year. Additionally, sales of products related to
COVID-19 accounted for 59% and 54% of our Life Science segment’s net revenues during fiscal 2021 and 2020, respectively, or 35% and 28% of each
year’s consolidated net revenues.
Critical Accounting Policies :
The Consolidated Financial Statements included in this Form 10-K have been prepared in accordance with U.S. generally accepted accounting principles.
Such accounting principles require management to make judgments about estimates and assumptions that affect the reported amounts of assets, liabilities,
revenues, expenses and related disclosures. Listed below are the accounting policies management believes to be critical to understanding the Consolidated
Financial Statements, along with reference to location of the policy discussion within the Consolidated Financial Statements. The listed policies are
considered critical due to the fact that application of such polices requires the use of significant estimates and assumptions, and the carrying values of
related assets and liabilities are material.
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Accounting Policy
Location
Within Consolidated
Financial Statements
Examples of Key Estimate Assumptions
Goodwill
Note 1(h)
Discounted cash flow assumptions (e.g., long-term growth
rates, discount rate, EBITDA)
Revenue Recognition
Note 1(i)
Distributor price adjustments and fee accruals
Income Taxes
Note 1(l) and Note 11
Uncertain positions and state apportionment factors
Recent Accounting Pronouncements :
A description of accounting pronouncements recently adopted by the Company, as well as accounting pronouncements issued but not yet adopted by the
Company, are set forth in Note 1(s), “Summary of Significant Accounting Policies- Recent Accounting Pronouncements” of the Consolidated Financial
Statements.
ITEM 7A.
QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
See Capital Resources and Market Risk Exposure above within Item 7, beginning on page 35.
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ITEM 8.
FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
Index to Consolidated Financial Statements
Management’s Report on Internal Control over Financial Reporting
39
Reports of Independent Registered Public Accounting Firms
40
Consolidated Statements of Operations for the years ended September 30, 2021, 2020 and 2019
44
Consolidated Statements of Comprehensive Income for the years ended September 30, 2021, 2020 and 2019
45
Consolidated Statements of Cash Flows for the years ended September 30, 2021, 2020 and 2019
46
Consolidated Balance Sheets as of September 30, 2021 and 2020
47
Consolidated Statements of Shareholders’ Equity for the years ended September 30, 2021, 2020 and 2019
49
Notes to Consolidated Financial Statements
50
Schedule No. II – Valuation and Qualifying Accounts for the years ended September 30, 2021, 2020 and 2019
80
All other supplemental schedules are omitted due to the absence of conditions under which they are required or because the information is shown in the
Consolidated Financial Statements or Notes thereto.
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MANAGEMENT’S REPORT ON INTERNAL CONTROL OVER FINANCIAL REPORTING
Management is responsible for establishing and maintaining adequate internal control over financial reporting, as defined in Exchange Act Rule 13a-15(f).
The Company’s internal control over financial reporting includes those policies and procedures that: (i) pertain to the maintenance of records that, in
reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the Company; (ii) provide reasonable assurance that
transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that
receipts and expenditures of the Company are being made only in accordance with authorizations of management and directors of the Company; and
(iii) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of the Company’s assets that
could have a material effect on the financial statements.
Because of its inherent limitations, internal control over financial reporting can only provide reasonable assurance and may not prevent or detect
misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of
changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.
Under the supervision and with the participation of our management, including the Chief Executive Officer and the Chief Financial Officer, we conducted
an evaluation of the effectiveness of our internal control over financial reporting as of September 30, 2021, based on the framework and criteria in the 2013
Internal Control – Integrated Framework, issued by the Committee of Sponsoring Organizations of the Treadway Commission (“COSO”). Based on
management’s evaluation and those criteria, the Company concluded that its system of internal control over financial reporting was effective as of
September 30, 2021.
The Company’s independent registered public accounting firm has issued an attestation report on the registrant’s internal control over financial reporting.
/s/ Jack Kenny
/s/ Bryan T. Baldasare
Jack Kenny
Bryan T. Baldasare
Chief Executive Officer
Executive Vice President and
November 23, 2021
Chief Financial Officer
November 23, 2021
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REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Shareholders and the Board of Directors of Meridian Bioscience, Inc.
Opinion on the Financial Statements
We have audited the accompanying consolidated balance sheet of Meridian Bioscience, Inc. (the Company) as of September 30, 2021, the related
consolidated statements of operations, comprehensive income, shareholders’ equity, and cash flows for the year then ended, and the related notes and
consolidated financial statement schedule listed in the Index to Annual Report on Form 10-K at Item 15 (collectively referred to as the “consolidated
financial statements”). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company at
September 30, 2021, and the results of its operations and its cash flows for the year then ended, in conformity with U.S. generally accepted accounting
principles.
We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the Company’s
internal control over financial reporting as of September 30, 2021, based on criteria established in Internal Control-Integrated Framework issued by the
Committee of Sponsoring Organizations of the Treadway Commission (2013 framework) and our report dated November 23, 2021, expressed an
unqualified opinion thereon.
Basis for Opinion
These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s financial
statements based on our audits. We are a public accounting firm registered with the PCAOB and are required to be independent with respect to the
Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the
PCAOB.
We conducted our audit in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable
assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. Our audit included performing procedures
to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks.
Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audit also included
evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial
statements. We believe that our audit provides a reasonable basis for our opinion.
Critical Audit Matter
The critical audit matter communicated below is a matter arising from the current period audit of the consolidated financial statements that was
communicated or required to be communicated to the audit committee and that: (1) relates to accounts or disclosures that are material to the consolidated
financial statements and (2) involved our especially challenging, subjective or complex judgments. The communication of the critical audit matter does not
alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit matter below,
providing a separate opinion on the critical audit matter or on the account or disclosure to which it relates.
Evaluation of Goodwill Impairment for the Diagnostics Reporting Unit
Description of the Matter
At September 30, 2021, the Company has recorded goodwill of $94.9 million within the Diagnostics reporting unit (within
the Diagnostics reportable segment). As discussed in Note 1 to the consolidated financial statements, goodwill is tested for
impairment annually at the beginning of the fourth quarter, or more frequently if indicators of potential impairment exist.
Auditing management’s annual goodwill impairment test related to Diagnostics reporting unit was especially challenging
due to the complexity of forecasting the long-term cash flows of the Diagnostics reporting unit and the estimation
uncertainty of certain assumptions included within such forecasts. The estimation uncertainty was primarily due to the
sensitivity of the Diagnostic reporting unit’s fair value to changes in the significant assumptions used in the income
approach, such as forecasted net revenues, earnings before interest, taxes, depreciation and amortization (EBITDA)
margins, long-term growth rates, and discount rates. These significant assumptions require a high degree of estimation and
judgment based on an evaluation of historical performance, current industry and macroeconomic conditions.
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How We Addressed the
Matter in Our Audit
We obtained an understanding, evaluated the design and tested the operating effectiveness of controls over the Company’s
annual goodwill impairment process, including controls over management’s review of the significant assumptions
described above and controls over management’s review of its financial forecasts and carrying value of the Diagnostics
reporting unit.
To test the estimated fair value of the Diagnostics reporting unit, we performed audit procedures that included, among
others, involving an internal valuation specialist to assist in our evaluation of the methodologies and certain significant
assumptions used by the Company. We assessed the reasonableness of the Company’s assumptions around forecasted net
revenues, EBITDA margins, long-term growth rates, and discount rates by comparing those assumptions to recent
historical performance, current economic and industry trends, and financial forecasts. We also assessed the reasonableness
of estimates included in the Company’s Diagnostics reporting unit financial forecast by evaluating how such assumptions
compared to economic, industry, and peer expectations. We evaluated management’s historical accuracy of forecasting
Diagnostics reporting unit net revenues and EBITDA margins by comparing past forecasts to subsequent actual activity.
We performed various sensitivity analyses around these significant assumptions to understand the impact on the fair value
calculation.
/s/ Ernst & Young LLP
We have served as the Company’s auditor since 2020.
Cincinnati, Ohio
November 23, 2021
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REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
Board of Directors and Shareholders
Meridian Bioscience, Inc.
Opinion on the financial statements
We have audited the accompanying consolidated balance sheet of Meridian Bioscience, Inc. (an Ohio corporation) and subsidiaries (the “Company”) as of
September 30, 2020, the related consolidated statements of operations, comprehensive income, shareholders’ equity, and cash flows for the years ended
September 30, 2020 and 2019, and the related notes (collectively referred to as the “financial statements”). In our opinion, the financial statements present
fairly, in all material respects, the financial position of the Company as of September 30, 2020, and the results of its operations and its cash flows for the
years ended September 30, 2020 and 2019, in conformity with accounting principles generally accepted in the United States of America.
Basis for opinion
These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s financial
statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States)
(“PCAOB”) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and
regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable
assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. Our audits included performing
procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to
those risks. Such procedures included examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements. Our audits
also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the
financial statements. We believe that our audits provide a reasonable basis for our opinion.
/s/ GRANT THORNTON LLP
We served as the Company’s auditor from 2005 to 2020.
Cincinnati, Ohio
November 23, 2020
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REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Shareholders and the Board of Directors of Meridian Bioscience, Inc.
Opinion on Internal Control Over Financial Reporting
We have audited Meridian Bioscience, Inc.’s (the Company) internal control over financial reporting as of September 30, 2021, based on criteria established
in Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 framework) (the
COSO criteria). In our opinion, the Company maintained, in all material respects, effective internal control over financial reporting as of September 30,
2021, based on the COSO criteria.
We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the consolidated
balance sheet of the Company as of September 30, 2021, the related consolidated statements of operations, comprehensive income, shareholders’ equity,
and cash flows for the year then ended, and the related notes and consolidated financial statement schedule listed in the Index to Annual Report on Form 10-
K at Item 15 and our report dated November 23, 2021, expressed an unqualified opinion thereon.
Basis for Opinion
The Company’s management is responsible for maintaining effective internal control over financial reporting and for its assessment of the effectiveness of
internal control over financial reporting included in the accompanying Management’s Report on Internal Control over Financial Reporting (“Management’s
Report”). Our responsibility is to express an opinion on the Company’s internal control over financial reporting based on our audit. We are a public
accounting firm registered with the PCAOB and are required to be independent with respect to the Company in accordance with the U.S. federal securities
laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audit in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable
assurance about whether effective internal control over financial reporting was maintained in all material respects.
Our audit included obtaining an understanding of internal control over financial reporting, assessing the risk that a material weakness exists, testing and
evaluating the design and operating effectiveness of internal control based on the assessed risk, and performing such other procedures as we considered
necessary in the circumstances. We believe that our audit provides a reasonable basis for our opinion.
Definition and Limitations of Internal Control Over Financial Reporting
A company’s internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting
and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. A company’s internal control
over financial reporting includes those policies and procedures that (1) pertain to the maintenance of records that, in reasonable detail, accurately and fairly
reflect the transactions and dispositions of the assets of the company; (2) provide reasonable assurance that transactions are recorded as necessary to permit
preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are
being made only in accordance with authorizations of management and directors of the company; and (3) provide reasonable assurance regarding prevention
or timely detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect on the financial statements.
Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of
effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of
compliance with the policies or procedures may deteriorate.
/s/ Ernst & Young LLP
Cincinnati, Ohio
November 23, 2021
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CONSOLIDATED STATEMENTS OF OPERATIONS (in thousands, except per share data)
Meridian Bioscience, Inc. and Subsidiaries
For the Year Ended September 30,
2021
2020
2019
Net Revenues
$317,896 $253,667 $201,014
Cost of Sales
116,748
97,419
82,286
Gross Profit
201,148 156,248 118,728
Operating Expenses:
Research and development
23,911
23,729
17,760
Selling and marketing
26,780
26,486
27,995
General and administrative
49,541
44,345
34,044
Product recall costs
5,596
—
—
Selected legal costs
2,803
2,080
1,583
Acquisition-related costs
392
3,890
1,808
Change in fair value of acquisition
consideration and settlement
(909)
(6,293)
—
Restructuring costs
—
687
2,839
Total Operating Expenses
108,114
94,924
86,029
Operating Income
93,034
61,324
32,699
Other Income (Expense):
Interest income
—
142
681
Interest expense
(1,878)
(2,632)
(1,945)
RADx grant income
1,000
—
—
Other, net
(1,705)
459
122
Total Other Expense, Net
(2,583)
(2,031)
(1,142)
Earnings Before Income Taxes
90,451
59,293
31,557
Income Tax Provision
19,044
13,107
7,175
Net Earnings
$ 71,407 $ 46,186 $ 24,382
Earnings Per Share Data:
Basic earnings per common share
$
1.65 $
1.08 $
0.57
Diluted earnings per common share
$
1.62 $
1.07 $
0.57
Common shares used for basic earnings per common share
43,259
42,855
42,571
Effect of dilutive stock options and restricted share units
753
319
328
Common shares used for diluted earnings per common share
44,012
43,174
42,899
Dividends declared per common share
$
— $
— $
0.25
Anti-Dilutive Securities:
Common share options and restricted share units
203
893
1,129
The accompanying notes are an integral part of these Consolidated Financial Statements.
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CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (in thousands)
Meridian Bioscience, Inc. and Subsidiaries
For the Year Ended September 30,
2021
2020
2019
Net Earnings
$71,407 $46,186 $24,382
Other Comprehensive Income (Loss):
Foreign currency translation adjustment
1,780
3,884
(802)
Unrealized gain (loss) on cash flow hedge
510
(713) (1,159)
Reclassification of amortization of gain on cash flow hedge
(154)
(308)
(102)
Income taxes related to items of other comprehensive income (loss)
(78)
252
465
Other Comprehensive Income (Loss), Net of Tax
2,058
3,115 (1,598)
Comprehensive Income
$73,465 $49,301 $22,784
The accompanying notes are an integral part of these Consolidated Financial Statements.
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CONSOLIDATED STATEMENTS OF CASH FLOWS (in thousands)
Meridian Bioscience, Inc. and Subsidiaries
For the Year Ended September 30,
2021
2020
2019
Cash Flows From Operating Activities
Net earnings
$ 71,407 $ 46,186 $ 24,382
Non-cash items included in net earnings:
Depreciation of property, plant and equipment
6,510
5,823
5,433
Amortization of intangible assets
8,776
7,744
4,531
Stock compensation expense
4,156
3,802
3,251
Deferred income taxes
(3,835)
760
(817)
Losses on dispositions of long-lived assets
9
64
632
Change in fair value of acquisition consideration and settlement
(909)
(6,293)
—
Change in the following, net of acquisitions:
Accounts receivable
(12,766)
(971)
(2,215)
Inventories
(7,800) (18,977)
3,841
Prepaid expenses and other current assets
(3,711)
(153)
(2,143)
Accounts payable and accrued expenses
6,346
7,248
(2,315)
Income taxes payable
(329)
1,435
1,793
Other, net
(989)
1,308
(198)
Net cash provided by operating activities
66,865 47,976 36,175
Cash Flows From Investing Activities
Purchase of property, plant and equipment
(18,312)
(3,299)
(3,797)
RADx grant proceeds offsetting cost of equipment
1,500
—
—
Payment of acquisition consideration holdback
(5,000)
—
—
Disposals of property, plant and equipment
—
—
669
Acquisitions, net of cash acquired and holdback
(18,585) (51,299) (45,324)
Net cash used in investing activities
(40,397) (54,598) (48,452)
Cash Flows From Financing Activities
Proceeds from revolving credit facility
10,000 50,000 75,824
Payment of acquisition consideration
(20,000)
—
—
Payment on revolving credit facility
(18,824) (57,000)
—
Payment on government grant obligations
(5,297)
—
—
Payment of debt issuance costs
—
(116)
(489)
Payments on term loan
—
— (50,250)
Proceeds from exercise of stock options
3,052
3,559
443
Dividends paid
—
— (10,612)
Net cash (used in) provided by financing activities
(31,069)
(3,557) 14,916
Effect of Exchange Rate Changes on Cash and Cash Equivalents
858
1,296
(1,005)
Net (Decrease) Increase in Cash and Cash Equivalents
(3,743)
(8,883)
1,634
Cash and Cash Equivalents at Beginning of Period
53,514 62,397 60,763
Cash and Cash Equivalents at End of Period
$ 49,771 $ 53,514 $ 62,397
Supplemental Cash Flow Information: See Notes 1(g), 3, 9, 10 and 11.
The accompanying notes are an integral part of these Consolidated Financial Statements.
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CONSOLIDATED BALANCE SHEETS (in thousands)
Meridian Bioscience, Inc. and Subsidiaries
As of September 30,
2021
2020
Assets
Current Assets:
Cash and cash equivalents
$ 49,771 $ 53,514
Accounts receivable, less allowances of $1,078 and $513, respectively
53,568
38,512
Inventories, net
76,842
61,264
Prepaid expenses and other current assets
12,626
8,900
Total Current Assets
192,807 162,190
Property, Plant and Equipment:
Land
989
991
Buildings and improvements
32,765
32,188
Machinery, equipment and furniture
78,410
69,854
Construction in progress
9,991
1,200
Subtotal
122,155 104,233
Less: accumulated depreciation and amortization
78,941
73,113
Net Property, Plant and Equipment
43,214
31,120
Other Assets:
Goodwill
114,668 114,186
Other intangible assets, net
84,151
83,197
Right-of-use assets, net
5,786
6,336
Deferred income taxes
8,731
7,647
Other assets
365
585
Total Other Assets
213,701 211,951
Total Assets
$449,722 $405,261
The accompanying notes are an integral part of these Consolidated Financial Statements.
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CONSOLIDATED BALANCE SHEETS (in thousands)
Meridian Bioscience, Inc. and Subsidiaries
As of September 30,
2021
2020
Liabilities and Shareholders’ Equity
Current Liabilities:
Accounts payable
$ 11,701 $ 11,969
Accrued employee compensation costs
16,853
16,661
Accrued product recall costs
5,100
—
Current portion of acquisition consideration
—
12,619
Current operating lease obligations
1,990
1,789
Current government grant obligations
638
600
Other accrued expenses
7,027
5,362
Income taxes payable
3,848
3,524
Total Current Liabilities
47,157
52,524
Non-Current Liabilities:
Acquisition consideration
1,000
13,290
Post-employment benefits
2,253
2,493
Fair value of interest rate swaps
203
713
Long-term operating lease obligations
3,932
4,678
Long-term debt
60,000
68,824
Government grant obligations
5,176
10,524
Long-term income taxes payable
469
549
Deferred income taxes
1,055
3,804
Other non-current liabilities
175
233
Total Non-Current Liabilities
74,263 105,108
Commitments and Contingencies
Shareholders’ Equity:
Preferred stock, no par value; 1,000,000 shares authorized; none issued
—
—
Common shares, no par value; 71,000,000 shares authorized, 43,361,898 and 43,068,842 issued, respectively
—
—
Additional paid-in capital
147,403 140,195
Retained earnings
180,701 109,294
Accumulated other comprehensive income (loss)
198
(1,860)
Total Shareholders’ Equity
328,302 247,629
Total Liabilities and Shareholders’ Equity
$449,722 $405,261
The accompanying notes are an integral part of these Consolidated Financial Statements.
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CONSOLIDATED STATEMENTS OF SHAREHOLDERS’ EQUITY (in thousands, except per share data)
Meridian Bioscience, Inc. and Subsidiaries
Common
Shares
Issued
Additional
Paid-in
Capital
Retained
Earnings
Accum Other
Comp
(Loss)
Income
Total
Balance at September 30, 2018
42,400 $129,193 $ 49,602
$
(3,377)
$175,418
Cash dividends paid - $0.250 per share
—
— (10,612)
—
(10,612)
Conversion of restricted share units and exercise of stock options
312
390
—
—
390
Stock compensation expense
—
3,251
—
—
3,251
Net earnings
—
—
24,382
—
24,382
Foreign currency translation adjustment
—
—
—
(802)
(802)
Hedging activity, net of tax
—
—
—
(944)
(944)
Adoption of ASU 2014-09
—
—
(116)
—
(116)
Adoption of ASU 2018-02
—
—
(148)
148
—
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
357
3,559
—
—
3,559
Stock compensation expense
—
3,802
—
—
3,802
Net earnings
—
—
46,186
—
46,186
Foreign currency translation adjustment
—
—
—
3,884
3,884
Hedging activity, net of tax
—
—
—
(769)
(769)
Balance at September 30, 2020
43,069 $140,195 $109,294
$
(1,860)
$247,629
Conversion of restricted share units and exercise of stock options
293
3,052
—
—
3,052
Stock compensation expense
—
4,156
—
—
4,156
Net earnings
—
—
71,407
—
71,407
Foreign currency translation adjustment
—
—
—
1,780
1,780
Hedging activity, net of tax
—
—
—
278
278
Balance at September 30, 2021
43,362 $147,403 $180,701
$
198
$328,302
The accompanying notes are an integral part of these Consolidated Financial Statements.
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Meridian Bioscience, Inc. and Subsidiaries
(in thousands, except per share data)
(1)
Summary of Significant Accounting Policies
(a)
Business Description - Meridian is a fully-integrated life science company whose principal businesses are: (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, specialized Polymerase Chain
Reaction (“PCR”) master mixes, isothermal mixes, enzymes, nucleotides, and bioresearch reagents used by other diagnostic manufacturers and
researchers.
Our reportable segments are Diagnostics and Life Science. The Diagnostics segment consists of: (i) manufacturing operations for infectious disease
products in Cincinnati, Ohio; Quebec City, Canada; and Modi’in, Israel; (ii) manufacturing operations for blood ch e mistry products in Billerica,
Massachusetts (near Boston); and (iii) the sale and distribution of diagnostics products domestically and abroad. This segment’s products are used by
hospitals, reference labs and physician offices to detect infectious diseases and elevated lead levels in blood.
The Life Science segment consists of: (i) manufacturing operations in Memphis, Tennessee; Boca Raton, Florida; London, England; and
Luckenwalde, Germany; and (ii) the sale and distribution of bulk antigens, antibodies, PCR/qPCR reagents, isothermal reagents, nucleotides, and
bioresearch reagents domestically and abroad, including a sales and business development facility, with outsourced distribution capabilities, in
Beijing, China. This segment’s products are used by manufacturers and researchers in a variety of applications (e.g., in vitro medical device
manufacturing, microRNA detection, next-generation sequencing, plant genotyping, and mutation detection, among others).
(b)
Principles of Consolidation and Basis of Presentation - The Consolidated Financial Statements include the accounts of Meridian Bioscience, Inc.
and its subsidiaries. All intercompany accounts and transactions have been eliminated in consolidation. Unless the context requires otherwise,
references to “Meridian,” “we,” “us,” “our” or “our company” refer to Meridian Bioscience, Inc. and its subsidiaries.
It should be noted that the terms revenue and/or revenues are utilized throughout these notes to the Consolidated Financial Statements to indicate net
revenue and/or net revenues.
(c)
Use of Estimates - The preparation of financial statements in conformity with U.S. generally accepted accounting principles (“GAAP”) requires
management to make estimates and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities
at the date of the Consolidated Financial Statements, and the reported amounts of net revenues and expenses during the reporting period. The
Company’s results are affected by economic, political, legislative, regulatory and legal actions. Economic conditions, such as recessionary trends,
inflation, interest and monetary exchange rates, government fiscal policies, government policies surrounding the containment of the ongoing COVID-
19 pandemic, and changes in prices of raw materials, can have a significant effect on the results of operations. Actual results could differ from the
Company’s estimates.
(d)
Foreign Currency Translation - Assets and liabilities of foreign operations are translated using year-end exchange rates with gains or losses
resulting from translation included as a separate component of accumulated other comprehensive income (loss). Net revenues and expenses are
translated using exchange rates prevailing during the year. We also recognize foreign currency transaction gains and losses on certain assets and
liabilities that are denominated in the Australian dollar, British pound, Canadian dollar, Chinese yuan, Euro, and New Israeli shekel currencies. These
gains and losses are included in other income (expense) in the Consolidated Statements of Operations.
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(e)
Cash and Cash Equivalents - We consider short-term investments with original maturities of 90 days or less to be cash equivalents, including
institutional money market funds. At times our investments of cash and cash equivalents with various high credit quality financial institutions may be
in excess of the Federal Deposit Insurance Corporation (“FDIC”) insurance limit.
( f)
Inventories - Inventories are stated at the lower of cost or net realizable value. Cost is determined on a first-in, first-out (“FIFO”) basis. Diagnostic
testing instruments are carried in inventory until they are sold outright or placed with a customer under the customer reagent rental program, at which
time they are transferred to property, plant and equipment.
We establish reserves against cost for excess and obsolete materials, finished goods whose shelf life may expire before sale to customers, and other
identified exposures. The Company specifically considered the impact of the ongoing COVID-19 pandemic on its inventories at September 30, 2021
and 2020. Such reserves were $4,997 and $3,629 at September 30, 2021 and 2020, respectively. We estimate these reserves based on assumptions
about future demand and market conditions. If actual demand and market conditions were to be less favorable than such estimates, additional
inventory write-downs would be required and recorded in the period known.
(g)
Property, Plant and Equipment - Property, plant and equipment are stated at cost. Upon retirement or other disposition, the cost and related
accumulated depreciation are removed from the accounts and the resulting gain or loss is reflected in net earnings. Maintenance and repairs are
expensed as incurred. Depreciation is computed on the straight-line method in amounts sufficient to write-off the cost over the estimated useful lives,
generally as follows:
Buildings and improvements - 18 to 40 years
Leasehold improvements - life of the lease
Machinery, equipment and furniture - 3 to 10 years
Computer equipment and software - 3 to 5 years
Instruments under customer reagent rental arrangements - 5 years
Supplemental Cash Flow Information (Non-Cash Capital Expenditures)
Additions to property, plant and equipment for which cash remained unpaid totaled $416, $236 and $108 at September 30, 2021, 2020 and 2019,
respectively.
(h)
Intangible Assets - Goodwill is subject to an annual impairment review (or more frequently if impairment indicators arise) at the reporting unit level,
which has historically been performed as of the last day of the third fiscal quarter (June 30). During the third quarter of fiscal 2021, the Company
decided to change the date of its annual goodwill impairment assessment from June 30 to July 1. The change was made to more closely align the
annual goodwill impairment assessment date with the Company’s annual planning and budgeting process, as well as its long-term planning and
forecasting process. The Company has determined this change in accounting principle is preferable and will not affect the Consolidated Financial
Statements. Pursuant to the authoritative accounting literature, in fiscal 2021 the Company performed a goodwill impairment assessment as of the last
day of its fiscal 2021 third quarter (June 30), as well as July 1, to ensure that the change in goodwill impairment assessment date did not delay or
avoid an impairment charge. This change is not applied retrospectively, as it is impracticable to do so because retrospective application would require
application of significant estimates and assumptions with the use of hindsight. Accordingly, the change will be applied prospectively.
At September 30, 2021, we had two reporting units (Diagnostics and Life Science), both of which contained goodwill. We review our reporting unit
structure annually, or more frequently if facts and circumstances warrant. Goodwill is considered impaired if the carrying value of the reporting unit
exceeds its fair value. We have no intangible assets with indefinite lives other than goodwill.
The historical annual impairment assessment of the Company’s goodwill as of June 30, 2021 , consisted of qualitative assessments for each of our
Diagnostics and Life Science reporting units. A qualitative assessment is first performed to determine whether it is more likely than not that the fair
value of a reporting unit is less than its carrying value using qualitative indicators. In the event that the reporting unit does not pass the
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qualitative assessment, the reporting unit’s carrying value is compared to its fair value, with fair value of the reporting unit estimated using market
value and discounted cash flow approaches. Both our Diagnostics and Life Science reporting units satisfied the qualitative assessments as of June 30,
2021, and no impairment was recognized. The updated annual goodwill impairment assessment of the Company’s goodwill as of July 1, 2021 ,
consisted of quantitative assessments for each of our Diagnostics and Life Science reporting units. The quantitative assessments determined fair value
via both market (comparable company) and income (discounted cash flows) approaches. The key assumptions for the market and income approaches
we use to determine fair value of our reporting units are updated at least annually. Those assumptions and estimates include macroeconomic
conditions, competitive activities, cost containment, market data and market multiples, discount rates, and terminal growth rates, as well as future
levels of net revenues growth and operating income margins, which are based upon the Company’s strategic plan. The strategic plan is updated as part
of its annual planning process and is reviewed and approved by management and the Board of Directors. The strategic plan may be revised as
necessary during a fiscal year, based on changes in market conditions or other changes in the reporting units. The discount rate assumption is based on
the overall after-tax rate of return required by a market participant whose weighted-average cost of capital includes both equity and debt, including a
risk premium. The discount rates may be impacted by adverse changes in the macroeconomic environment, including specifically the ongoing
COVID-19 pandemic, volatility in the equity and debt markets, or other fact o rs. While the Company can implement and has implemented certain
strategies to address these events, changes in operating plans or adverse changes in the future could reduce the underlying cash flows used to estimate
reporting unit fair values and could result in a decline in fair value that would trigger a future impairment charge of the reporting unit’s goodwill
balance. Based upon these approaches, the fair value of each reporting unit exceeded its carrying value; therefore, each of the Diagnostics and Life
Science reporting units satisfied the quantitative assessment at July 1, 2021. The impact of the ongoing COVID-19 pandemic has had varying impacts
on the Diagnostics and Life Science reporting units, and specifically an adverse impact on the Diagnostics reporting unit. However, even in light of
the COVID-19 pandemic, the estimated fair value of the Diagnostics reporting unit, as calculated at July 1, 2021, was over 50% greater than its
carrying value.
Long-lived assets, excluding goodwill, are reviewed for impairment when events or circumstances indicate that such assets may not be recoverable at
their carrying value. Whether an event or circumstance triggers an impairment is determined by comparing an estimate of the asset’s future
undiscounted cash flows to its carrying value. If impairment has occurred, it is measured by a fair-value based calculation.
Our ability to recover the carrying value of our identifiable intangible assets is dependent upon the future cash flows of the related assets. We make
judgments and assumptions regarding future cash flows, including net revenues levels, gross profit margins, operating expense levels, working capital
levels, and capital expenditures. With respect to identifiable intangible assets and fixed assets, we also make judgments and assumptions regarding
useful lives.
We consider the following factors in evaluating events and circumstances for possible impairment: (i) significant under-performance relative to
historical or projected operating results; (ii) negative industry trends; (iii) net revenues levels of specific groups of products (related to specific
identifiable intangibles); (iv) changes in overall business strategies; and (v) other factors. If actual cash flows are less favorable than projections, this
could trigger impairment of identifiable intangible assets and other long-lived assets. No triggering events have been identified by the Company for
the years ended September 30, 2021, 2020 and 2019.
(i)
Revenue Recognition and Accounts Receivable -
Revenue Recognition Policies
Product Sales
Revenue from contracts with customers is recognized in an amount that reflects the consideration we expect to receive in exchange for products when
obligations under such contracts are satisfied. Revenue is generally recognized at a point-in-time when products are shipped, and control has passed to
the customer. Such contracts can include various combinations of products that are generally accounted for as distinct performance obligations.
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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 is reduced at the date of sale for product price adjustments payable to certain distributors
under local contracts. Management estimates accruals for distributor price adjustments based on local contract terms, sales data provided by
distributors, historical statistics, current trends, and other factors. Changes to the accruals are recorded in the period that they become known. Such
accruals are netted against accounts receivable.
Shipping and handling costs incurred after control of the product is transferred to our customers are treated as fulfillment costs and not a separate
performance obligation.
Our payment terms differ by jurisdiction and customer, but payment is generally required in a term ranging from 30 to 90 days from the date of
shipment or satisfaction of the performance obligation. Accounts receivable are recorded in the Consolidated Balance Sheets at invoiced amounts less
provisions for distributor price adjustments under local contracts and doubtful accounts. The allowance for doubtful accounts represents our estimate
of probable credit losses and is based on historical write-off experience and known conditions that would likely lead to non-payment. Customer
invoices are charged off against the allowance for doubtful accounts when we believe it is probable that the invoices will not be paid. The Company
specifically considered the impact of the ongoing COVID-19 pandemic on its accounts receivable and determined there was no material impact on
existing accounts receivable at September 30, 2021 or 2020.
Practical Expedients and Exemptions
Revenue is recognized net of any taxes collected from customers (sales tax, value added tax, etc.), which are subsequently remitted to government
authorities.
Our diagnostic assay products are generally not subject to a customer right of return except for product recall events under the rules and regulations of
the U.S. Food and Drug Administration (“FDA”) or equivalent agencies outside the U.S. In this circumstance, the costs to replace or refund affected
products would be accrued at the time a loss was probable and estimable.
We expense as incurred the costs to obtain contracts, as the amortization period would be one year or less. These costs, recorded within selling and
marketing expense, include our internal sales force compensation programs and certain partner sales incentive programs, as we have determined that
annual compensation is commensurate with annual selling activities.
Reagent Rental Arrangements
Certain of our Diagnostics segment’s product platforms require the use of instruments for the tests to be processed. In many cases, a customer is given
use of the instrument provided they continue purchasing the associated tests, also referred to as “consumables” or “reagents”. If a customer stops
purchasing the consumables, the instrument must be returned to us. Such arrangements are common practice in the diagnostics industry and are
referred to as “Reagent Rentals”. Reagent Rentals may also include instrument related services such as a limited replacement warranty, training and
installation. We concluded that the use of the instrument and related services (collectively known as “lease elements”) are not within the scope of
Accounting Standards Codification (“ASC”) 606, Revenue from Contracts with Customers but rather ASC 842, Leases . Accordingly, we first allocate
the transaction price between the lease elements and the non-lease elements based on estimates of relative standalone selling prices. Lease revenue is
derived solely from the sale of consumables and is therefore recognized monthly as earned, which coincides with the transfer of control of the non-
lease elements.
For the portion of the transaction price allocated to the non-lease elements, which are principally the test kits, the related revenue is recognized at a
point-in-time when control transfers.
(j)
Fair Value Measurements - Certain assets and liabilities are recorded at fair value in accordance with ASC 820-10, Fair Value Measurements and
Disclosures . ASC 820-10 defines fair value as the price that would be received to sell an asset or would be paid to transfer a liability in an orderly
transaction between market participants at the measurement date. ASC 820-10 establishes a three-level hierarchy, which prioritizes the inputs to
valuation techniques used to measure fair value. The hierarchy level assigned to each asset and liability is based on the assessment of the
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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
(k)
Research and Development Costs - Research and development costs are charged to expense as incurred. Research and development costs include,
among other things, salaries and wages for research scientists, materials and supplies used in the development of new products, costs for development
of instrumentation equipment, costs for clinical trials, costs of regulatory compliance activities, and costs for facilities and equipment.
(l)
Income Taxes - The provision for income taxes includes federal, foreign, state and local income taxes currently payable and those deferred because
of temporary differences between income for financial reporting and income for tax purposes. We prepare estimates of permanent and temporary
differences between income for financial reporting purposes and income for t a x purposes. These differences are adjusted to actual upon filing of our
tax returns, typically occurring in the third and fourth quarters of the current fiscal year for the preceding fiscal year’s estimates.
The Company has certain deferred income tax assets in select jurisdictions. The recoverability of these deferred income tax assets is assessed
periodically, and valuation allowances are recognized if it is determined that it is more likely than not that the benefits will not be realized. When
performing the assessment, the Company considers the ability to carryback losses to prior tax periods, future taxable income, the reversal of existing
temporary differences, and tax planning strategies.
We account for uncertain tax positions using a benefit recognition model with a two-step approach: (i) a more-likely-than-not recognition criterion;
and (ii) a measurement attribute that measures the position as the largest amount of tax benefit that is greater than 50% likely of being ultimately
realized upon ultimate settlement. If it is not more likely than not that the benefit will be sustained on its technical merits, no benefit is recorded. We
recognize accrued interest related to unrecognized tax benefits as a portion of our income tax provision in the Consolidated Statements of Operations.
(m)
Stock-Based Compensation - We recognize compensation expense for all share-based awards made to employees based upon the fair value of the
share-based award on the date of the grant.
(n)
Comprehensive Income (Loss) - Comprehensive income (loss) represents the net change in shareholders’ equity during a period from sources other
than transactions with shareholders. As reflected in the Consolidated Statements of Comprehensive Income, our comprehensive income is comprised
of net earnings, foreign currency translation, unrealized gain (loss) on our current cash flow hedge, unrecognized gain (loss) on termination of our
previous cash flow hedge, and the income taxes thereon.
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(o)
Shipping and Handling Costs - Shipping and handling costs invoiced to customers are included in net revenues. Costs to distribute products to
customers, including freight costs, warehousing costs, and other shipping and handling activities are included in cost of sales.
(p)
Non-Income Government-Assessed Taxes - We classify all non-income, government-assessed taxes (sales, use and value-added) collected from
customers and remitted by us to appropriate revenue authorities, on a net basis (excluded from net revenues) in the Consolidated Statements of
Operations.
(q)
Acquisitions - Assets and liabilities associated with business acquisitions are recorded at fair value, using the acquisition method of accounting. The
Company allocates the purchase price of acquisitions based upon the fair value of each component, which may be derived from observable or
unobservable inputs and assumptions. The Company may utilize third-party valuation specialists to assist us in this allocation. Initial purchase price
allocations are preliminary and subject to revision within the measurement period, generally not to exceed one year from the date of acquisition.
(r)
Other income (expense), net - Other income (expense), net, consists principally of transaction currency gains or losses. When a transaction is
denominated in a currency other than the subsidiary’s functional currency, the Company recognizes a transaction gain or loss in other income
(expense), net within the Consolidated Statements of Operations when the transaction is settled.
(s)
Recent Accounting Pronouncements -
Pronouncements Adopted
On October 1, 2020, the Company adopted Financial Accounting Standards Board (“FASB”) Accounting Standards Update (“ASU”) 2016-13,
Measurement of Credit Losses on Financial Instruments , which changed the impairment model used to measure credit losses for most financial
assets. Use of the new forward-looking expected credit loss model for our accounts receivable valuation, rather than the previously utilized incurred
credit loss model, did not have a material impact on the Consolidated Financial Statements.
Pronouncements Issued but Not Yet Adopted as of September 30, 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 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 is currently evaluating ASU 2020-04 but does not expect its application to have a
material impact on the Consolidated Financial Statements.
In December 2019, the FASB 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 intra-period 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 ASU 2019-12 but does not expect its application to have a material impact on the Consolidated Financial Statements.
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(2)
Revenue Recognition
The following tables present our net revenues disaggregated by major geographic region, major product platform and disease state (Diagnostics segment
only):
Net Revenues by Reportable Segment & Geographic Region
Year Ended September 30,
2021
2020
2019
Diagnostics-
Americas
$101,293
$ 97,228
$110,109
EMEA
24,475
21,826
23,888
ROW
1,992
2,078
2,685
Total Diagnostics
127,760
121,132
136,682
Life Science-
Americas
46,063
37,391
19,441
EMEA
93,655
58,125
28,850
ROW
50,418
37,019
16,041
Total Life Science
190,136
132,535
64,332
Consolidated
$317,896
$253,667
$201,014
Net Revenues by Product Platform/Type
Year Ended September 30,
2021
2020
2019
Diagnostics-
Molecular assays
$ 19,037
$ 21,907
$ 26,283
Non-molecular assays
108,723
99,225
110,399
Total Diagnostics
$127,760
$121,132
$136,682
Life Science-
Molecular reagents
$130,537
$ 78,431
$ 23,261
Immunological reagents
59,599
54,104
41,071
Total Life Science
$190,136
$132,535
$ 64,332
Net Revenues by Disease State (Diagnostics only)
Year Ended September 30,
2021
2020
2019
Diagnostics-
Gastrointestinal assays
$ 68,890
$ 55,040
$ 68,982
Respiratory illness assays
17,608
26,694
26,622
Blood chemistry assays
15,398
17,534
18,639
Other
25,864
21,864
22,439
Total Diagnostics
$127,760
$121,132
$136,682
Royalty Income
Royalty income received from a third party related to sales of H. pylori products, totaled approximately $6,330 , $3,540 and $3,440 for the years ended
September 30, 2021 , 2020 and 2019 , respectively. Such revenue is included as part of Non-molecular assays and Other within the Revenue by Product
Platform/Type and Revenue by Disease State tables, respectively, above.
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Reagent Rental Arrangements
Revenue allocated to the lease elements of Reagent Rental arrangements totaled approximately $3,710 , $4,600 and $4,150 for the years ended
September 30, 2021 , 2020 and 2019 , respectively. Such revenue is included as part of net revenues in our Consolidated Statements of Operations.
(3)
Fair Value Measurements
To 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 10 to a fixed rate. The fair values of the interest rate swap
agreements were determined by reference to a third-party valuation and is considered a Level 2 input within the fair value hierarchy of valuation techniques.
As indicated in Note 4, we acquired the BreathTek business and Exalenz Bioscience Ltd. (“Exalenz”) in fiscal 2021 and 2020, respectively. In the
BreathTek acquisition, the fair values of inventories acquired were valued using Level 2 inputs, which included data points that were observable, such as
established values of comparable assets and historical sales information (market approach). Identifiable 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 .
In the Exalenz acquisition, the fair values of the 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 (market approach). Identifiable intangible assets and contingent consideration were valued using
Level 3 inputs, which are unobservable by nature, a nd included internal estimates of future cash flows (income approach). Significant increases (decreases)
in any of those unobservable inputs, as of the date of the acquisition, in isolation would result in a significantly lower (higher) fair value measurement.
Management engaged a third-party valuation firm to assist in the determination of acquisition fair values, and specifically those considered Level 3
measurements. Management ultimately maintained oversight over the third-party valuation firm to ensure that the transaction-specific assumptions were
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 was 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. Giving effect to subsequent agreements to modify certain terms of the
agreement related to contingent consideration achievement levels and milestone dates, the fair value of the product development milestone payments were
estimated by discounting the probability-weighted contingent payments to present value and presented on the Consolidated Balance Sheets based on the
Company’s anticipated date of payment at each reporting period. Assumptions used in the calculations included probability of success, duration of the earn-
out and discount rate, with such calculations being updated for the effect of the previously noted amendments 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 included expected net revenues, probability of certain developments, expected expenses and discount rate. In August
2021, the Company paid $20,000 to settle the contingent consideration obligation, resulting in a $909 net gain for the year ended September 30, 2021.
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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 swap agreements -
As of September 30, 2021
$
(203) $ —
$ (203) $
—
As of September 30, 2020
$
(713) $ —
$ (713) $
—
Contingent consideration -
As of September 30, 2021
$
— $ —
$ — $
—
As of September 30, 2020
$(20,909) $ —
$ — $(20,909)
Supplemental Cash Flow Information (Non-Cash Acquisition Consideration)
In arriving at the $20,000 settlement payment, the acquisition consideration obligation related to acquisition of the GenePOC business decreased $909 and
$6,293 during the years ended September 30, 2021 and 2020, respectively, due in large part to amendment of certain terms of the original contingent
consideration achievement levels and milestone dates, as well as the settlement in August 2021.
(4)
Business Combinations
Acquisition of BreathTek Business
On July 31, 2021 (“the BreathTek acquisition date”), we acquired the BreathTek business, a urea breath t e st 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
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 primarily 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 a preliminary basis at $9,855 and $9,730,
respectively, with the useful life of the customer relationships estimated at five years. The Company’s fiscal 2021 consolidated results include $3,840 of net
revenues from sales of BreathTek products, which contributed approximately $1,000 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 $324 for the year
ended September 30, 2021.
Unaudited Pro Forma Information – BreathTek
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 2020:
Year Ended September 30,
2021
2020
Net revenues
$337,118
$279,573
Net earnings
77,270
53,305
Acquisition of Exalenz
On April 30, 2020 (“the Exalenz 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 10).
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In anticipation of the acquisition, 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. The settlement of the currency contracts resulted in an $845 gain, which is reflected within other
income (expense) in the Consolidated Statement of Operations for the year ended September 30, 2020.
As a result of total consideration exceeding the fair value of the net assets acquired, goodwill in the amount of $24,459 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 system
through our established customer base and distribution channels. The Consolidated Statement of Operations for the year ended September 30, 2020 ,
included $3,890 of acquisition-related costs related to the Exalenz acquisition, which are reflected in operating expenses.
The Company’s consolidated results include the following from Exalenz:
Year Ended September 30,
2021
2020
Net revenues
$14,905
$ 4,206
Net loss
(3,381)
(1,911)
These results, which are reported as part of the Diagnostics segment, include amortization expense related to specific identifiable assets recorded in the
purchase price allocation, including a non-compete agreement, trade name, technology and customer relationships, totaling $2,960 and $1,120 for the years
ended September 30, 2021 and 2020, respectively.
The following table summarizes the final (as of April 30, 2021 ) fair values of the identifiable assets acquired and liabilities assumed in the acquisition of
Exalenz (as of the Exalenz acquisition date):
April 30, 2020
Fair value of assets acquired -
Cash
$
5,006
Accounts receivable
637
Inventories
4,026
Other current assets
2,676
Property, plant and equipment
528
Goodwill
24,459
Other intangible assets (estimated useful life):
Non-compete agreement (5 years)
110
Trade name (10 years)
3,860
Technology (15 years)
6,120
Customer relationships (10 years)
20,640
Right-of-use assets
1,311
Deferred tax assets, net
7,119
76,492
Fair value of liabilities assumed -
Accounts payable and accrued expenses (including current portion of lease
and government grant obligations)
8,008
Long-term lease obligations
1,096
Long-term government grant obligations
10,792
Other non-current liabilities
291
20,187
Total consideration paid (including $8,068 to pay off long-term debt)
$
56,305
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Unaudited Pro Forma Information – Exalenz
The following table provides the unaudited consolidated pro forma results for the periods presented as if Exalenz had been acquired as of the beginning of
fiscal 2019. Pro forma results do not include the effect of any synergies anticipated to be achieved from the acquisition, and accordingly, are not necessarily
indicative of the results that would have occurred if the acquisition had occurred on the date indicated or that may result in the future.
Year Ended September 30,
2020
2019
Net revenues
$261,131
$214,613
Net earnings
45,843
19,089
These pro forma amounts have been calculated by including the results of Exalenz and adjusting the combined results to give effect to the following, as if
the acquisitions had been consummated on October 1, 2018, together with the consequential tax effects thereon:
Year Ended September 30,
2020
2019
Adjustments to Net Revenues
Exalenz pre-acquisition revenues
$ 7,464
$13,599
Adjustments to Net Earnings
Exalenz pre-acquisition net losses
$ (6,423)
$ (4,006)
Pro forma adjustments:
Meridian acquisition-related costs
3,890
—
Exalenz transaction-related costs
4,550
—
Gain on Exalenz purchase price currency contracts
(845)
—
Remove net impact of non-continuing activities
(305)
1,441
Incremental depreciation and amortization
(1,680)
(3,027)
Incremental interest costs, net
(183)
(728)
Tax effects of pro forma adjustments and recognizing benefit on resulting
Exalenz losses
653
1,027
Total Adjustments to Net Earnings
$
(343)
$ (5,293)
(5)
Lead Testing Matters
On September 1, 2021, the Company’s wholly owned subsidiary Magellan announced the expansion of a Cl a ss 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 have
reported to us that the control results are 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 we have not determined the root cause at this time, we currently believe that the issue
relates to the plastic containers used for the treatment reagent, which are supplied by a firm in China. The Company is working 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.
Although evaluation of the recall and the related notification process is ongoing, approximately $5,100 has been estimated and accrued as of September 30,
2021, to cover the currently estimated costs of the recall . In total, approximately $5,600 of recall-related expense has been included within the
Consolidated Statement of Operations for the year ended September 30, 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.
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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. 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 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 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. The Company cannot predict when the investigation will be resolved, the outcome of the
investigation, or its potential impact on the Company. Approximately $ 2,803 , $ 2,035 and $ 1,585 of expense for attorneys’ fees related to this matter is
included within the Consolidated Statements of Operations for the years ended September 30, 2021, 2020 and 2019, respectively.
Magellan submitted 510(k) applications in December 2018, seeking to reinstate venous blood sample-types for its LeadCare II, LeadCare Plus and
LeadCare Ultra testing systems. In the second fiscal quarter of 2019 the FDA informed Magellan that each of these 510(k) applications had been put on
Additional Information hold. On July 15, 2019, we provided responses to the FDA’s requests for Additional Information. These 510(k) applications have
since expired and are no longer under FDA review. Further, while Magellan’s LeadCare testing systems remain cleared for marketing by the FDA and
permitted for use with capillary blood samples, the FDA advised that it has commissioned a third-party study of the Company’s LeadCare testing systems
using both venous and capillary blood samples. According to the FDA, the results of the field study will be used in conjunction with other information to
determine whether further action by the FDA or the Centers for Disease Control and Prevention (“CDC”) is necessary to protect the public health. The
Company intends to fully cooperate with the FDA or CDC on any follow-up based on the third-party study.
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. Since the inspection, we have submitted a number of written responses to the FDA regarding the five Form FDA 483 observations
issued 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).
During June 2021, the FDA performed an inspection of Magellan’s manufacturing facility. As a result of this inspection, the FDA issued one Form 483
observation. On August 3, 2021, FDA sent Magellan a close-out letter for the Warning Letter that FDA issued to Magellan on October 23, 2017. FDA’s
close-out letter notified Magellan that FDA has completed an evaluation of Magellan’s corrective actions in response to FDA’s Warning Letter, and based
on FDA’s evaluation, Magellan has addressed the issues identified in the Warning Letter. 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.
(6)
Cash and Cash Equivalents
Cash and cash equivalents are comprised of the following:
As of September 30,
2021
2020
Institutional money market funds
$ 1,020
$ 1,017
Cash on hand, unrestricted
48,751
52,497
Total
$49,771
$53,514
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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.
(7)
Inventories
Inventories are comprised of the following:
As of September 30,
2021
2020
Raw materials
$14,843
$11,966
Work-in-process
25,072
19,477
Finished goods - instruments
2,260
1,594
Finished goods - kits and reagents
34,667
28,227
Total
$76,842
$61,264
(8)
Goodwill and Other Intangible Assets, Net
During fiscal 2021, goodwill increased $482, reflecting: (i) a $56 increase from the currency translation adjustment on goodwill in the Diagnostics segment;
(ii) a $433 increase from the currency translation adjustment on goodwill in the Life Science segment; and (iii) a $7 decrease related to Exalenz, reflecting
additional measurement period adjustments (see Note 4).
A summary of Meridian’s intangible assets subject to amortization is as follows.
2021
2020
As of September 30,
Gross
Carrying
Value
Accum.
Amort.
Gross
Carrying
Value
Accum.
Amort.
Manufacturing technologies, core products and cell lines
$ 62,416
$22,633
$ 62,363
$18,750
Tradenames, licenses and patents
18,489
9,492
18,425
7,801
Customer lists, customer relationships and supply agreements
54,941
19,649
45,071
16,210
Non-compete agreements
110
31
110
11
$135,956
$51,805
$125,969
$42,772
The aggregate amortization expense for these intangible assets for the years ended September 30, 2021, 2020 and 2019 was $8,776, $7,744 and $4,531,
respectively. The estimated aggregate amortization expense for these intangible assets for each of the five succeeding fiscal years is as follows: fiscal 2022 -
$9,940, fiscal 2023 - $9,925, fiscal 2024 - $9,920, fiscal 2025 - $9,915 and fiscal 2026 - $8,915.
(9)
Leasing Arrangements
The Company is party to several 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
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.
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The lease costs for these operating leases reflected in our Consolidated Statements of Operations, as well as the right-of-use assets, net obtained during these
periods in exchange for operating lease liabilities, are as follows:
Year Ended September 30,
2021
2020
Lease costs within cost of sales
$
795
$
597
Lease costs within operating expenses
1,542
1,286
Right-of-use assets, net obtained in exchange for operating lease liabilities
1,073
1,600
The amounts charged to expense under operating leases in fiscal 2019 tot a led $2,372. 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 Consolidated Balance Sheet s and the related
lease expense is immaterial for fiscal 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 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 were as follows:
As of September 30,
2021
2020
Weighted average remaining lease term
3.6 yrs.
4.2 yrs.
Average discount rate
3.2%
3.7%
Maturities of lease liabilities by fiscal year for the Company’s operating lease liabilities were as follows as of September 30, 2021:
2022
$2,194
2023
1,558
2024
1,178
2025
918
2026
326
Thereafter
65
Total lease payments
6,239
Less amount of lease payment representing interest
(317)
Total present value of lease payments
$5,922
Supplemental Cash Flow Information (Cash Paid for Amounts Included in Measurement of Lease Liabilities)
Year Ended September 30,
2021
2020
Cash paid for amounts included in the measurement of lease liabilities:
Operating cash flows from operating leases
$2,228
$1,693
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(10) Bank Credit Arrangements
The Company maintains a revolving credit facility with a commercial bank in an aggregate principal amount not to exceed $160,000, which expires in May
2024 (see Note 17 for discussion of the post Consolidated Balance Sheet date amendment to the revolving credit facility). Outstanding principal amounts
bear 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 2.51% and
3.30% on the revolving credit facility during fiscal 2021 and 2020, respectively. In light of the interest being determined on a variable rate basis, the fair
value of the borrowings under the credit facility at both September 30, 2021 and 2020 approximates the current carrying value reflected in the Consolidated
Balance Sheets of $60,000 and $68,824, respectively, which is consistent with a level 2 fair v a lue 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 September 30, 2021, the Company was in compliance with all covenants.
Supplemental Cash Flow Information (Interest Paid)
Cash paid for interest totaled $1,348, $2,690 and $1,405 in fiscal 2021, 2021 and 2019, respectively.
(11) Income Taxes
(a)
Earnings before income taxes, and the related income tax provision were as follows:
Year Ended September 30,
2021
2020
2019
Domestic
$11,354
$ 9,068
$23,954
Foreign
79,097
50,225
7,603
Total earnings before income taxes
$90,451
$59,293
$31,557
Provision (benefit) for income taxes -
Federal -
Current
$ 4,431
$ 1,173
$ 5,001
Deferred
(2,595)
744
(477)
State and local
1,163
1,170
834
Foreign -
Current
16,305
10,194
1,915
Deferred
(260)
(174)
(98)
Total income tax provision
$19,044
$13,107
$ 7,175
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(b)
The following is a reconciliation between the statutory U.S. income tax rate and the effective rate derived by dividing the income tax provision by
earnings before income taxes:
Year Ended September 30,
2021
2020
2019
Computed income taxes at statutory rate
$18,995 21.0% $12,452 21.0% $6,627 21.0%
Increase (decrease) in taxes resulting from -
State and local income taxes
1,204 1.3
773 1.3
577 1.8
Foreign-Derived Intangible Income tax
(563) (0.6)
(136) (0.2) (294) (0.9)
Global Intangible Low Taxed Income (“GILTI”) tax
8,061 8.9
4,970 8.4
1,119 3.5
Foreign tax credit
(7,802) (8.6) (4,767) (8.0) (990) (3.1)
Foreign tax rate differences
(869) (1.0)
(534) (0.9)
46 0.1
Transaction costs
— —
548 0.9
— —
Uncertain tax position activity
205 0.2
62 0.1
126 0.4
Valuation allowance
729 0.8
229 0.3
364 1.2
Stock-based compensation
(498) (0.5)
41 0.1
(33) (0.1)
Other, net
(418) (0.4)
(531) (0.9) (367) (1.2)
$19,044 21.1% $13,107 22.1% $7,175 22.7%
The Company’s GILTI and foreign tax credit details were as follows:
Year Ended September 30,
2021
2020
2019
U.S. GILTI inclusion
$38,384
$23,666
$5,328
Resulting permanent tax expense
8,061
4,970
1,119
Offsetting foreign tax credit
(7,802)
(4,767)
(990)
(c)
The components of net deferred taxes were as follows:
As of September 30,
2021
2020
Deferred tax assets -
Valuation reserves and non-deductible expenses
$
4,939
$
4,848
Stock compensation expense not deductible
2,276
1,804
Net operating loss and tax credit carryforwards
12,711
10,757
Basis difference in equity-method investee
302
302
Inventories basis differences
692
382
Other
—
207
Subtotal
20,920
18,300
Less valuation allowance
(1,624)
(895)
Deferred tax assets
19,296
17,405
Deferred tax liabilities -
Property, plant and equipment basis differences and depreciation
(4,778)
(4,269)
Intangible asset basis differences and amortization
(6,495)
(9,293)
Other
(347)
—
Deferred tax liabilities
(11,620)
(13,562)
Net deferred tax assets
$
7,676
$
3,843
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For income tax purposes, we have recorded deferred tax assets related to operating loss and tax credit carryforwards of $179 in the U.S. and $12,532 in
foreign jurisdictions as of September 30, 2021, reduced by valuation reserves totaling $1,322. At September 30, 2020, such deferred tax assets totaled $205
and $10,552, respectively, reduced by valuation reserves totaling $593. The operating loss carryforwards in foreign jurisdictions, the majority of which
relate to Israel, have no expiration date. The operating loss carryforwards in the U.S. expire in 2023 at the federal level, and in 2036 at the state level. The
aggregate amount of federal, state and foreign operating loss carryforwards separately totaled $118, $2,400 and $88,442, respectively, at September 30,
2021. The use of the federal and state losses is limited by the change of ownership provisions of the Internal Revenue Code.
The Company has recognized a deferred tax liability of $865 and $185 at September 30, 2021 and 2020, respectively, to reflect the corporate and
withholding tax impact of a presumed repatriation of foreign earnings.
The realization of deferred tax assets is dependent upon the generation of future taxable incom e in the applicable jurisdictions. We have considered the
levels of currently anticipated pre-tax income in U.S. and foreign jurisdictions in assessing the required level of the deferred tax asset valuation allowance
including the characterization of the income as ordinary or capital. Taking into consideration historical and current operating results, and other factors, we
believe that it is more likely than not that the net deferred tax asset of $19,296 will be realized. The amount of the net deferred tax asset considered
realizable, however, could be reduced in future years if estimates of future taxable income are reduced.
We utilize a comprehensive model for the recognition, measurement, presentation and disclosure of uncertain tax positions, assuming full knowledge of all
relevant facts by the applicable tax authorities. The total amount of unrecognized tax benefits at September 30, 2021 and 2020 related to such positions was
$700 and $568, respectively, of which $627 at September 30, 2021 would favorably impact the effective tax rate if recognized. We generally recognize
interest and penalties related to uncertain tax positions as a component of our income tax provision. During fiscal 2021 and 2020, such penalties and interest
totaled approximately $31 and $20, respectively. We had approximately $170 accrued for the payment of interest and penalties at September 30, 2021,
compared to $138 accrued at September 30, 2020. The amount of our liability for uncertain tax positions expected to be paid or settled in the next 12
months is uncertain.
A reconciliation of the beginning and ending amounts of unrecognized tax benefits is as follows:
Year Ended September 30,
2021
2020
2019
Unrecognized income tax benefits at beginning of year
$568
$509
$388
Additions for tax positions of prior years
34
—
83
Reductions for tax positions of prior years
—
—
(38)
Additions for tax positions of current year
138
104
138
Tax examination and other settlements
(40)
(45)
(62)
Unrecognized income tax benefits at end of year
$700
$568
$509
We are subject to examination by the tax authorities in the U.S. (both federal and state) and the countries of Australia, Belgium, Canada, China, England,
France, Germany, Holland, Israel and Italy. In the U.S., tax years subsequent to fiscal 2017 remain open. In countries outside the U.S., open tax years
generally range from fiscal 2016 and forward. However, in Australia and Belgium, the utilization of local net operating loss carryforwards extends the
statute of limitations for examination well into the foreseeable future. To the extent that adjustments result from the completion of these examinations or the
lapsing of statutes of limitation, they will affect tax liabilities in the period known. We believe that the results of any tax authority examinations would not
have a significant adverse impact on our consolidated financial condition or results of operations.
Supplemental Cash Flow Information (Income Taxes Paid)
Cash paid for income taxes totaled $27,466, $9,816 and $7,840 in fiscal 2021, 2020 and 2019, respectively.
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(12) Employee Benefits
(a)
Savings and Investment Plan - We have a profit sharing and retirement savings plan covering substantially all full-time U.S. employees. Profit
sharing contributions to the plan, which are discretionary, are approved by the board of directors. The plan permits participants to contribute to the
plan through salary reduction. Under terms of the plan, we match 100% of an employee’s contributions, up to a maximum match of 4% of eligible
compensation. Our discretionary and matching contributions to the plan, which are recorded primarily within operating expenses, amounted to
approximately $2,869, $2,434 and $1,979, for the years ended September 30, 2021, 2020 and 2019, respectively.
(b)
Stock-Based Compensation Plans - During fiscal 2021, the Company had two active stock-based compensation plans, the 2012 Stock Incentive
Plan, which became effective January 25, 2012 (the “2012 Plan”) and the 2021 Omnibus Award Plan, which became effective January 27, 2021 (the
“2021 Plan”).
The 2021 Plan is authorized to grant new shares for options, restricted shares or restricted share units for up to 2,839 shares, including 1,839 non-
granted shares from the 2012 Plan permitted to be carried forward and added to the 2021 Plan authorized limit. As of September 30, 2021, 71 shares
have been granted under the 2021 Plan, thereby resulting in a remaining authorized limit of 2,768 shares. Options may be granted at exercise prices
not less than 100% of the closing market value of the underlying common shares on the date of grant and have maximum terms up to ten years.
Vesting schedules for options, restricted shares and restricted share units are established at the time of grant and may be set based on future service
periods, achievement of performance targets, or a combination thereof. All options contain provisions restricting their transferability and limiting their
exercise in the event of termination of employment, or the disability or death of the optionee. We recognize compensation expense for all share-based
payments made to employees, based upon the fair value of the share-based payment on the date of the grant.
During fiscal years 2019 through 2021, we granted, in the aggregate for the three-year period, approximately 823 restricted share units (with
weighted-average grant date fair values of $18.66 per share in fiscal 2019, $10.13 per share in fiscal 2020 and $18.81 per share in fiscal 2021) to
certain employees, including CEO, Jack Kenny, as separately detailed below. The units granted in fiscal 2021, 2020 and 2019 were generally time-
vested restricted share units vesting in total on the third anniversary of the grant date.
During fiscal 2020, in connection with Mr. Kenny’s Amended and Restated Employment Agreement, effective October 1, 2019, we granted to
Mr. Kenny: (i) options to purchase approximately 198 shares of common stock of the Company (with a grant date fair value of $3.38 per share)
vesting on a pro rata basis over the three years ending October 1, 2022; and (ii) approximately 100 restricted share units (with a grant date fair value
of $10.10 per share) vesting 100% on the October 1, 2022, which are included within the restricted share units noted above.
Giving effect to these grants, cancellations and certain other activities for restricted shares and restricted share units throughout the years, including
conversions to common shares, forfeitures, and new hire and employee promotion grants, approximately 682 restricted share units remain outstanding
as of September 30, 2021, with a weighted-average grant date fair value of $14.73 per share, a weighted-average remaining vesting period of 1.12
years and an aggregate intrinsic value of $13,121. The weighted-average grant date fair value of the approximate 79 restricted share units that vested
during fiscal 2021 was $15.61 per share.
The amount of stock-based compensation expense was $4,156, $3,802 and $3,251 for the years ended September 30, 2021, 2020 and 2019,
respectively. The fiscal 2021 expense is comprised of $1,080 related to stock options and $3,076 related to restricted share units; the fiscal 2020
expense is comprised of $1,006 related to stock options and $2,796 related to restricted share units ; and the fiscal 2019 expense is comprised of $542
related to stock options and $2,709 related to restricted share units. The total income tax benefit recognized in the Consolidated Statements of
Operations for these stock-based compensation arrangements was $1,516, $898 and $572, for the years ended September 30, 2021, 2020 and 2019,
respectively. As of September 30, 2021, we expect future stock compensation expense for unvested options and unvested restricted share units to total
$902 and $3,438, respectively, which will be recognized during fiscal years 2022 through 2024.
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We recognize stock-based compensation expense only for the portion of shares that we expect to vest. As such, we apply estimated forfeiture rates to
our stock-based compensation expense calculations. These rates have been derived using historical forfeiture data, stratified by several employee
groups, and range from 0% to 16% in each of the years ended September 30, 2021, 2020 and 2019. During the years ended September 30, 2021, 2020
and 2019, we recorded $183, $148 and $127, respectively, in stock-based compensation expense to adjust estimated forfeiture rates to actual.
We have elected to use the Black-Scholes option pricing model to determine grant-date fair value for stock options, with the following assumptions:
(i) expected share price volatility based on the average of Meridian’s historic a l volatility over the options’ expected lives and implied volatility
based on the value of tradable call options; (ii) expected life of options based on contractual lives, employees’ historical exercise behavior and
employees’ historical post-vesting employment termination behavior; (iii) risk-free interest rates based on treasury rates that correspond to the
expected lives of the options; and (iv) dividend yield based on the expected yield on underlying Meridian common stock. A summary of these key
assumptions are as follows:
Year ended September 30,
2021
2020
2019
Share price volatility
53%-59%
34%
29%
Life of option
4.00-7.47 yrs.
6.51 yrs
.
6.51 yrs
.
Risk-free interest rates
0.26% - 0.79%
1.60%
2.99%
Dividend yield
0 %
0%
3.3%
A summary of the status of our stock option plans as of September 30, 2021, and changes during the year ended September 30, 2021, is presented in
the table and narrative below:
Options
Wtd Avg
Exercise
Price
Wtd Avg
Remaining
Life (Yrs)
Aggregate
Intrinsic
Value
Outstanding beginning of period
1,103
$ 14.67
Grants
167
19.28
Exercises
(219)
14.48
Forfeitures
(19)
11.46
Cancellations
(31)
21.85
Outstanding end of period
1,001
$ 15.31
6.55
$ 4,299
Exercisable end of period
598
$ 15.90
5.44
$ 2,276
A summary of the status of our nonvested options as of September 30, 2021, and changes during the year ended September 30, 2021, is presented
below:
Options
Weighted-
Average
Grant Date
Fair Value
Nonvested beginning of period
429
$
3.36
Granted
167
9.18
Vested
(174)
3.59
Forfeitures
(19)
2.83
Nonvested end of period
403
$
5.70
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For the years ended September 30, 2021, 2020 and 2019: (i) the weighted average grant-date fair value of options granted was $9.18, $3.54 and $3.61,
respectively; (ii) the total intrinsic value of options exercised was $2,890, $1,585 and $62, respectively; and (iii) the total grant-date fair value of
options that vested was $621, $528 and $735, respectively.
Cash received from options exercised was $3,052, $3,559 and $443 for the years ended September 30, 2021, 2020 and 2019, respectively.
(13) Contingent Obligations and Non-Current Liabilities
In connection with the acquisition of Exalenz (see Note 4), 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 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. Following the repayment of a substantial portion (approximately $5,300)
of the higher rate grant obligations during fiscal 2021, these obligation amounts total $5,814 and $11,124 as of September 30, 2021 and 2020, with the grant
obligations remaining at September 30, 2021, bearing interest at rates ranging from 0.58% to 2.02%.
The grant obligations are reflected in the Consolidated Balance Sheets as follows:
Year Ended September 30,
2021
2020
Current liabilities
$
638
$
600
Non-current liabilities
5,176
10,524
Additionally, the Company has provided certain post-employment benefits to its former Chief Executive Officer, and these obligations total $1,676 and
$1,840 at September 30, 2021 and 2020, respectively. In addition, the Company is required by the governments of certain foreign countries in which we
operate to maintain a level of accruals for potential future severance indemnity. These accruals total $754 and $814 at September 30, 2021 and 2020,
respectively.
(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. The Company has received $1,000 under the grant contract for reimbursement of eligible research and development expenditures.
These amounts are included within other income (expense) in the Consolidated Statement of Operations for the year ended September 30, 2021.
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. As of
September 30, 2021, $1,500 has been received related to this contract and is reflected as a reduction in the cost of equipment within construction in progress
on the Consolidated Balance Sheet.
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(15) Reportable Segments and Major Concentration Data
The Company’s reportable segments maintain separate financial information for which results of operations are evaluated on a regular basis by the
Company’s chief operating decision maker in deciding how to allocate resources and in assessing performance.
The Company records the direct costs of business operations to the reportable segments, including allocations for certain corporate-wide costs such as
treasury management, human resources and technology, among others. Corporate provides certain ex e cutive 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 segments.
Segment and Corporate information is as follows:
Diagnostics
Life Science
Corporate
(1)
Eliminations
(2)
Total
Fiscal 2021
Net revenues -
Third-party
$ 127,760
$ 190,136
$
—
$
—
$317,896
Inter-segment
351
207
—
(558)
—
Operating (loss) income
(8,140)
115,250
(14,164)
88
93,034
Depreciation and amortization
13,432
1,854
—
—
15,286
Capital expenditures
15,827
2,485
—
—
18,312
Goodwill
94,904
19,764
—
—
114,668
Other intangible assets, net
84,149
2
—
—
84,151
Total assets
339,208
110,536
—
(22)
449,722
Fiscal 2020
Net revenues -
Third-party
$ 121,132
$ 132,535
$
—
$
—
$253,667
Inter-segment
326
261
—
(587)
—
Operating (loss) income
3,885
68,826
(11,437)
50
61,324
Depreciation and amortization
11,451
2,116
—
—
13,567
Capital expenditures
1,850
1,449
—
—
3,299
Goodwill
94,855
19,331
—
—
114,186
Other intangible assets, net
83,179
18
—
—
83,197
Total assets
306,812
98,483
—
(34)
405,261
Fiscal 2019
Net revenues -
Third-party
$ 136,682
$
64,332
$
—
$
—
$201,014
Inter-segment
462
361
—
(823)
—
Operating (loss) income
25,390
17,581
(10,373)
101
32,699
Depreciation and amortization
7,676
2,288
—
—
9,964
Capital expenditures
2,049
1,748
—
—
3,797
Goodwill
70,395
18,846
—
—
89,241
Other intangible assets, net
59,807
436
—
—
60,243
Total assets
255,169
70,392
—
(83)
325,478
(1)
Includes Restructuring and Selected Legal Costs of $2,803, $2,080 and $2,596 for the years ended September 30, 2021, 2020 and 2019, respectively.
(2)
Eliminations consist of inter-segment transactions.
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A reconciliation of reportable segment operating income to consolidated earnings before income taxes is as follows:
Year Ended September 30,
2021
2020
2019
Operating (loss) income:
Diagnostics segment
$ (8,140)
$
3,885
$ 25,390
Life Science segment
115,250
68,826
17,581
Eliminations
88
50
101
Total reportable segment operating income
107,198
72,761
43,072
Corporate operating expenses
(14,164)
(11,437)
(10,373)
Interest income
—
142
681
Interest expense
(1,878)
(2,632)
(1,945)
RADx initiative grant income
1,000
—
—
Other, net
(1,705)
459
122
Consolidated earnings before income taxes
$ 90,451
$ 59,293
$ 31,557
Transactions between reportable segments are accounted for at established intercompany prices for internal and management purposes with all
intercompany amounts eliminated in consolidation.
During the years ended September 30, 2021 and 2020, products related to COVID-19 accounted for 59% and 54%, respectively, of Life Science segment
net revenues , and 35% and 28%, respectively, of consolidated net revenues. In addition, net revenues generated by the Company’s three major
Diagnostics segment product families – gastrointestinal, respiratory illnesses and blood chemistry – accounted for 32%, 39% and 57% of consolidated net
revenues during the years ended September 30, 2021, 2020 and 2019, respectively.
While no individual Diagnostics or Life Science segment customers accounted for greater than 10% of consolidated net revenues during the years ended
September 30, 2021, 2020 and 2019, individual Diagnostics or Life Science segment customers, including their affiliates, comprising 10% or more of
reportable segment net revenues were as follows:
Year Ended September 30,
2021
2020
2019
Diagnostics
Customer A
10%
12%
13%
Customer B
11%
13%
12%
Customer C
12%
7%
6%
Life Science
Customer D
6%
6%
18%
Customer E
3%
13%
7%
Customer F
13%
11%
2%
In addition, for the years ended September 30, 2021, 2020 and 2019, the Life Science segment’s ten largest customers, including their affiliates, accounted
for approximately 44 %, 48 % and 42 %, respectively, of Life Science segment net revenues, and 27 %, 25 % and 13 %, respectively, of consolidated net
revenues.
One Diagnostics segment customer (Customer B above) and one Life Science segment customer (Customer F above) accounted for approximately 12% and
10%, respectively, of consolidated accounts receivable as of September 30, 2021. As of September 30, 2020, only Customer F above accounted for greater
than 10% of consolidated accounts receivable, accounting for approximately 15%.
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Net revenues generated by the Company outside of the U.S. and its territories totaled $173,475, $121,596 and $74,193 for the years ended September 30,
2021, 2020 and 2019, respectively, with net revenues by country for the Diagnostics and Life Science segments as follows (net revenues are attributed to the
geographic area based on the location to which the product is delivered):
Year Ended September 30,
2021
2020
2019
U.S. and territories
$ 99,636
$ 95,382
$107,890
Italy
12,240
9,797
10,911
France
2,283
2,238
2,446
United Kingdom
2,197
2,312
2,396
Belgium
1,554
1,440
1,468
Holland
1,279
1,183
1,413
Finland
1,069
275
291
Japan
551
848
1,572
Other countries
6,951
7,657
8,295
Total Diagnostics
$127,760
$121,132
$136,682
Year Ended September 30,
2021
2020
2019
U.S. and territories
$ 44,785
$ 36,689
$18,931
Germany
18,460
14,190
12,663
Finland
17,936
2,518
500
China
13,559
19,047
8,464
United Kingdom
13,097
14,765
4,709
Spain
12,593
7,242
4,414
France
10,733
5,579
2,200
South Korea
9,242
1,908
1,134
Australia
9,115
5,957
3,458
Italy
7,516
4,067
1,357
Turkey
7,281
2,819
290
Japan
6,532
3,707
1,624
India
5,558
2,099
143
Indonesia
5,183
3,027
169
Holland
3,197
3,212
710
Canada
1,073
547
322
Other countries
4,276
5,162
3,244
Total Life Science
$190,136
$132,535
$64,332
In locations outside the U.S., the Company’s identifiable assets were concentrated as follows at the end of the most recent fiscal years, with no additional
country’s total of assets exceeding $5,000:
As of September 30,
2021
2020
Israel
$80,416
$70,097
United Kingdom
30,027
27,373
Germany
22,293
12,877
Canada
15,236
9,865
Italy
6,921
7,858
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(16) Commitments and Contingent Obligations
(a)
Royalty Commitments - We have entered into various license agreements that require payment of royalties based on a specified percentage of net
revenues from licensed products, with such percentages generally ranging from approximately 3% to 10%. During the year ended September 30,
2021, royalty expense associated with these agreements totaled approximately $5,200, with 25% and 75% of such expense relating to our Diagnostics
and Life Science segments, respectively. These royalty expenses are recognized as the related revenues are earned and are recorded as a component of
cost of sales. Annual royalty expenses associated with these agreements totaled approximately $1,900 and $2,100 for the years ended September 30,
2020 and 2019, respectively , with approximately 80% and 85%, respectively, of such expense relating to the Diagnostics segment.
(b)
Purchase Commitments - Excluding the operating lease commitments reflected in Note 9, w e have purchase commitments primarily for inventories
and service items as part of the normal course of business. Commitments made under these obligations are $49,537 for fiscal 2022 and $1,758 for
fiscal 2023 through fiscal 202 6 . No purchase commitments have been made beyond fiscal 202 6 .
(c)
Litigation - We are a party to various litigation matters from time to time that we believe are in the normal course of business. The ultimate
resolution of these routine matters is not expected to have a material adverse effect on our consolidated financial position, results of operations or cash
flows. Additionally, the Company has also become a party to certain legal matters that are somewhat outside the normal course of business. See Note
5 for a discussion of Magellan’s DOJ matter.
(d)
Indemnifications - In conjunction with certain contracts and agreements, we provide routine indemnifications related to our performance obligations.
The terms of these indemnifications range in duration and in some circumstances are not explicitly defined. The maximum obligation under some
such indemnifications is not explicitly stated and, as a result of our having no history of paying such indemnifications, cannot be reasonably
estimated. We have not made any payments for these indemnifications and no liability is recorded at September 30, 2021 or 2020.
(17) Subsequent Events
On October 25, 2021, the Company’s revolving credit facility with a commercial bank was amended primarily to: (i) increase the borrowing capacity to
$200,000; (ii) extend the term to October 25, 2026; and (iii) modify the financial covenants to more closely align with the Company’s size and strategic
plans. Other details of the credit facility remain relatively unchanged.
On November 9, 2021, notification was received from the FDA that emergency use authorization (“EUA”) had been granted for the Company’s Revogene
SARS-CoV-2 assay.
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ITEM 9.
CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS
ON ACCOUNTING AND FINANCIAL DISCLOSURE
Following a request for proposal (“RFP”) process, effective December 22, 2020 (the “Effective Date”), the Audit Committee of the Board of Directors of
Meridian selected Ernst & Young LLP (“EY”) as the Company’s independent registered public accounting firm for the Company’s fiscal year ended
September 30, 2021. The Audit Committee dismissed Grant Thornton LLP (“Grant Thornton”), the Company’s current independent registered public
accounting firm, effective as of the Effective Date.
Grant Thornton’s reports on the Company’s Consolidated Financial Statements as of and for the fiscal years ended September 30, 2020 and 2019 did not
contain any adverse opinion or disclaimer of opinion, nor were they qualified or modified as to uncertainty, audit scope, or accounting principles. During
the fiscal years ended September 30, 2020 and 2019, and the subsequent interim period through the Effective Date, there were: (i) no disagreements within
the meaning of Item 304(a)(1)(iv) of Regulation S-K and the related instructions, between the Company and Grant Thornton, on any matters of accounting
principles or practices, consolidated financial statement disclosure, or auditing scope or procedure which, if not resolved to Grant Thornton’s satisfaction,
would have caused Grant Thornton to make reference thereto in their reports; and (ii) no “reportable events” within the meaning of Item 304(a)(1)(v) of
Regulation S-K.
The Company requested that Grant Thornton furnish a letter addressed to the SEC stating whether or not it agrees with the above statements, and, if not,
stating the respects in which it does not agree. A copy of Grant Thornton’s letter, dated December 28, 2020, was filed as Exhibit 16.1 to Meridian’s Form 8-
K filed on or about December 30, 2020.
During the fiscal years ended September 30, 2020 and 2019 and the subsequent interim period through the Effective Date, neither the Company nor anyone
on its behalf has consulted with EY regarding: (i) the application of accounting principles to a specific transaction, either completed or proposed, or the type
of audit opinion that might be rendered on the Company’s Consolidated Financial Statements, and neither a written report nor oral advice was provided to
the Company that EY concluded was an important factor considered by the Company in reaching a decision as to any accounting, auditing, or financial
reporting issue; (ii) any matter that was the subject of a disagreement within the meaning of Item 304(a)(1)(iv) of Regulation S-K and the related
instructions; or (iii) any “reportable event” within the meaning of Item 304(a)(1)(v) of Regulation S-K.
ITEM 9A.
CONTROLS AND PROCEDURES
As of September 30, 2021, an evaluation was completed under the supervision and with the participation of our management, including our Chief Executive
Officer and Chief Financial Officer, of the effectiveness of the design and operation of our disclosure controls and procedures pursuant to Rule 13a-15(b)
and 15d-15(b) promulgated under the Securities Exchange Act of 1934, as amended (the “Exchange Act”). Based on that evaluation, our management,
including the CEO and CFO, concluded that our disclosure controls and procedures were effective as of September 30, 2021. There have been no changes in
our internal control over financial reporting identified in connection with the evaluation of internal control that occurred during the fourth fiscal quarter that
has materially affected, or is reasonably likely to affect, our internal control over financial reporting, or in other factors that could significantly affect
internal control subsequent to September 30, 2021.
Our internal control report is included in this Form 10-K after Item 8, under the caption “Management’s Report on Internal Control over Financial
Reporting.”
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ITEM 9B.
OTHER INFORMATION
On November 19, 2021 David C. Phillips, Chairman of the Board, notified the Board of Directors that he would not be standing for re-election at the 2022
Annual Meeting of Shareholders. Meridian is grateful for Mr. Phillips’ 21 years of loyal service and wishes him well in his future endeavors.
Also, effective November 19, 2021 Tony Serafini-Lamanna, Executive Vice President, Diagnostics and the Company entered into a Change in Control
Agreement (“CIC Agreement”), the form of which is filed with this report as Exhibit 10.11.
The CIC agreement has an initial term ending December 31, 2021, and each year will automatically renew for an additional one-year term, provided
however, that if a change in control occurs the term will expire no earlier than 24 calendar months after the calendar month in which such change in control
occurs. This agreement is the result of Management’s and the Board’s periodic review and updates of certain policies and practices. The CIC Agreement
provides, among other things, that if a change in control occurs during the term of the CIC Agreement, and the executive’s employment is terminated either
by us or by the executive, other than: (a) by us for cause; (b) by reason of death or disability; or (c) by the executive without good reason, such executive
will receive a severance payment equal to: (A) a multiple of such executive’s annual base salary; (B) a multiple of executive’s target bonus amounts; and
(C) earned but unused vacation time. In addition, the CIC Agreement provides that in the event that the severance and other benefits provided for in the
agreement or otherwise payable to the executive would be subject to the excise tax imposed by Section 4999 of the Internal Revenue Code, the benefits
under the CIC Agreement will be either delivered in full or delivered to a lesser extent which would result in no portion of the benefits being subject to such
excise tax, whichever is more beneficial to the executive.
PART III.
ITEM 10.
DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
Information about our directors and officers may be found under the captions “Election of Directors” and “Directors and Executive Officers” in our Proxy
Statement for the Annual Meeting of Shareholders to be held January 26, 2022 (the “Proxy Statement”). Information about our Audit Committee may be
found under the caption “Committees of the Board of Directors” in the Proxy Statement. That information is incorporated herein by reference.
We have adopted a code of ethics that applies to all of our employees, including our Chief Executive Officer, Chief Financial Officer, Chief Accounting
Officer, and other finance organization employees. The code of ethics is publicly available on our website at www.meridianbioscience.com . If we make
any substantive amendments to the code of ethics or grant any waiver, including any implicit waiver, from a provision of the code to our Chief Executive
Officer, Chief Financial Officer, or Chief Accounting Officer, we will disclose the nature of the amendment or waiver on that website or in a report on
Form 8-K.
ITEM 11.
EXECUTIVE COMPENSATION
The information in the Proxy Statement set forth under the captions “Director Compensation,” “Compensation Discussion and Analysis,” “Compensation
Committee Interlocks and Insider Participation,” and “Compensation Committee Report” is incorporated herein by reference.
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ITEM 12.
SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS
The information in the Proxy Statement set forth under the captions “Security Ownership of Certain Beneficial Owners” and “Equity Compensation Plan
Information” is incorporated herein by reference.
ITEM 13.
CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE
The information set forth in the Proxy Statement under the captions “Corporate Governance” and “Transactions with Related Persons” is incorporated
herein by reference.
ITEM 14.
PRINCIPAL ACCOUNTING FEES AND SERVICES
Information concerning principal accountant fees and services appears in the Proxy Statement under the headings “Principal Accounting Firm Fees” and
“Committees of the Board of Directors” and is incorporated herein by reference.
ITEM 15.
EXHIBITS AND FINANCIAL STATEMENT SCHEDULES
(a)
(1) and (2) FINANCIAL STATEMENTS AND SCHEDULES.
All financial statements and schedules required to be filed by Item 8 of this Form and included in this report have been so identified under Item 8. No
additional financial statements or schedules are being filed since the requirements of paragraph (c) under Item 15 are not applicable to Meridian.
(b)
(3) EXHIBITS.
Exhibit
Number
Description of Exhibit
3.1
Amended Articles of Incorporation (Incorporated by reference to Meridian’s Form 10-K filed with the Securities and Exchange
Commission (“SEC”) on November 26, 2019)
3.2
Amended and Restated Code of Regulations (Incorporated by reference to Meridian’s Form 10-K filed with the SEC on November 26,
2019)
4.1
Description of Securities (Incorporated by reference to Meridian’s Form 10-K filed with the SEC on November 26, 2019)
10.1*
Amendment No. 1 to Supplemental Benefit Agreement Dated September 23, 2014 between Meridian and John A. Kraeutler (Incorporated
by reference to Meridian’s Form 8-K filed with the SEC on September 25, 2014)
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Table of Contents
10.2*
Third Amended and Restated Employment Agreement Dated October 3, 2016 between Meridian and John A. Kraeutler (Incorporated by
reference to Meridian’s Form 8-K filed with the SEC on October 5, 2016)
10.3*
Amended and Restated Employment Agreement dated effective October 1, 2019 between Meridian and John P. Kenny (Incorporated by
reference to Meridian’s Form 8-K filed with the SEC on November 7, 2019)
10.4*
2012 Stock Incentive Plan, effective January 25, 2012 (Incorporated by reference to Meridian’s Quarterly Report on Form 10-Q for the
Quarterly Period Ended December 31, 2011)
10.5*
Israeli Appendix to the Meridian Bioscience, Inc. 2012 Stock Incentive Plan dated effective July 10, 2020 (Incorporated by reference to
Meridian’s Annual Report on Form 10-K for the Fiscal Year Ended September 30, 2020)
10.6*
Meridian Bioscience, Inc. 2021 Omnibus Award Plan ((Incorporated by reference to Meridian’s Quarterly Report on Form 10-Q for the
Quarterly Period Ended March 31, 2021)
10.7*
Form of Time-Based Restricted Share Unit Award Agreement (Filed herewith)
10.8*
Form of Nonqualified Stock Option Agreement (Filed herewith)
10.9*†
Chief Executive Officer Cash-Based Incentive Compensation Plan for Fiscal Year 2021 (Incorporated by reference to Meridian’s
Quarterly Report on Form 10-Q for the Quarterly Period Ended December 31, 2020)
10.10*†
Executive Vice President Cash-Based Incentive Compensation Plan for Fiscal Year 2021 (Incorporated by reference to Meridian’s
Quarterly Report on Form 10-Q for the Quarterly Period Ended December 31, 2020)
10.11*
Form of Meridian Bioscience, Inc. Change in Control Agreement dated August 4, 2016 (Incorporated by reference to Meridian’s
Quarterly Report on Form 10-Q for the Quarterly Period Ended June 30, 2016)
10.12
Amended and Restated Credit Agreement, dated as of October 25, 2021, by and among Meridian Bioscience, Inc., 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 Meridian’s Form 8-K filed with the SEC on October 29, 2021)
21
List of Subsidiaries of the Registrant (Filed herewith)
23.1
Consent of Independent Registered Public Accounting Firm (Filed herewith)
23.2
Consent of Independent Registered Public Accounting Firm (Filed herewith)
31.1
Certification of Principal Executive Officer required by Rule 13a-14(a) (Filed herewith)
31.2
Certification of Principal Financial Officer required by Rule 13a-14(a) (Filed herewith)
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32**
Section 1350 Certification of Chief Executive Officer and Chief Financial Officer (Furnished herewith)
101.INS***
Inline XBRL Instance Document
101.SCH***
Inline XBRL Taxonomy Extension Schema
101.CAL***
Inline XBRL Taxonomy Extension Calculation Linkbase
101.DEF***
Inline XBRL Taxonomy Extension Definition Linkbase
101.LAB***
Inline XBRL Taxonomy Extension Label Linkbase
101.PRE***
Inline XBRL Taxonomy Extension Presentation Linkbase
104***
Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101)
*
Management Compensatory Contracts
**
Furnished, not filed
***
Pursuant to Rule 406T of Regulation S-T, these interactive data files are deemed not filed or part of a registration statement or prospectus for purposes
of Sections 11 or 12 of the Securities Act of 1933 or Section 18 of the Securities Exchange Act of 1934 and otherwise are not subject to liability.
†
Schedules to and 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.
Meridian will provide shareholders with any exhibit upon the payment of a specified reasonable fee, which fee shall be limited to Meridian’s reasonable
expenses in furnishing such exhibit.
ITEM 16.
FORM 10-K SUMMARY
Not applicable.
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Table of Contents
SIGNATURES
Pursuant to the requirements of Sections 13 or 15(d) 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.
By: /s/ Jack Kenny
Date: November 23, 2021
Jack Kenny
Chief Executive Officer
We, the undersigned directors and officers of the Registrant, hereby severally constitute Jack Kenny and Bryan T. Baldasare, and each of them singly, our
true and lawful attorneys with full power to them and each of them to sign for us, in our names in the capacities indicated below, any and all amendments to
the Annual Report on Form 10-K filed with the Securities and Exchange Commission.
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed by the following persons on behalf of the Registrant and in
the capacities and on the dates indicated.
Signature
Capacity
Date
/s/ Jack Kenny
Chief Executive Officer and Director
November 23, 2021
Jack Kenny
/s/ Bryan T. Baldasare
Executive Vice President, Chief
November 23, 2021
Bryan T. Baldasare
Financial Officer and Secretary
(Principal Financial and Accounting Officer)
/s/ David C. Phillips
Chairman of the Board
November 23, 2021
David C. Phillips
/s/ James M. Anderson
Director
November 23, 2021
James M. Anderson
/s/ Anthony P. Bihl III
Director
November 23, 2021
Anthony P. Bihl III
/s/ Dwight E. Ellingwood
Director
November 23, 2021
Dwight E. Ellingwood
/s/ John C. McIlwraith
Director
November 23, 2021
John C. McIlwraith
/s/ John M. Rice, Jr.
Director
November 23, 2021
John M. Rice, Jr.
/s/ Catherine A. Sazdanoff
Director
November 23, 2021
Catherine A. Sazdanoff
/s/ Felicia Williams
Director
November 23, 2021
Felicia Williams
- 7 9 -
Table of Contents
SCHEDULE II
Meridian Bioscience, Inc.
and Subsidiaries
Valuation and Qualifying Accounts
(Dollars in thousands)
Years Ended September 30, 2021, 2020 and 2019
Description
Balance at
Beginning
of Period
Charged to
Costs and
Expenses
Deductions
Other (a)
Balance at
End of
Period
Year Ended September 30, 2021:
Allowance for doubtful accounts
$
513
$
583
$
(34)
$
16
$
1,078
Inventory realizability reserves
3,629
2,703
(1,297)
(38)
4,997
Valuation allowances – deferred taxes
895
729
—
—
1,624
Year Ended September 30, 2020:
Allowance for doubtful accounts
$
537
$
34
$
(75)
$
17
$
513
Inventory realizability reserves
2,441
1,775
(564)
(23)
3,629
Valuation allowances – deferred taxes
666
335
(106)
—
895
Year Ended September 30, 2019:
Allowance for doubtful accounts
$
310
$
347
$
(100)
$
(20)
$
537
Inventory realizability reserves
1,971
930
(448)
(12)
2,441
Valuation allowances – deferred taxes
302
364
—
—
666
(a)
Balances reflect the effects of currency translation.
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Exhibit 10.7
MERIDIAN BIOSCIENCE, INC.
2021 OMNIBUS AWARD PLAN
RESTRICTED SHARE UNIT AWARD AGREEMENT
TIME-BASED (U.S. EMPLOYEES)
Summary of Restricted Share Unit Award Grant
Meridian Bioscience, Inc., an Ohio corporation (the “Company”), grants to the Grantee named below, in accordance with the terms
of the Meridian Bioscience, Inc. 2021 Omnibus Award Plan (the “Plan”) and this Restricted Share Unit Award Agreement (the “Agreement”),
the following number of Restricted Share Units of the Company (the “Restricted Units”), on the Grant Date set forth below:
Name of Grantee:
Number of Units:
Grant Date:
November 4, 2021
Vesting Date:
25% November 4, 2022
25% November 4, 2023
25% November 4, 2024
25%
November 4, 2025
Terms of Agreement
1. Grant of Restricted Share Unit Awards. Subject to and upon the terms, conditions, and restrictions set forth in this
Agreement and in the Plan, the Company hereby grants to the Grantee as of the Grant Date, the total number of Restricted Units set forth above.
The Restricted Units shall be credited in a book entry account established for the Grantee until payment in accordance with Section 4 hereof.
2. Vesting of Restricted Units.
(a) Except as otherwise provided in this Agreement, this grant of Restricted Units shall vest in full on the Vesting Date
above. Prior to the Vesting Date, no portion of the award is vested, except as otherwise provided in Section 2.
(b) All of the Restricted Units shall vest in full prior to the Vesting Date upon the occurrence of any of the following:
(i) the Grantee dies while in the employ of the Company; (ii) the Grantee satisfies the requirements for Retirement, including separation from
employment with the Company; or (iii) the Grantee has a Disability.
(c) The Committee may, in its sole discretion, accelerate the time at which the Restricted Units become vested and
non-forfeitable to a time other than the Vesting Date as provided in
Section 2(a) or to a time other than provided in Section (2)(b)(i), (ii), or (iii) on such terms and conditions as it deems appropriate in accordance
with the terms and conditions of the Plan, provided such acceleration does not result in an impermissible acceleration of payments under
Section 409A of the Code.
(d) The extent to which the Restricted Units may vest upon a Change in Control is described on Appendix A attached
hereto.
3. Forfeiture of Restricted Units.
(a) The Restricted Units that have not yet vested pursuant to Section 2 shall be forfeited automatically without further
action or notice if the Grantee ceases to be employed by the Company other than as provided in Section 2 hereof.
(b) The Grantee hereby acknowledges that in order for the Restricted Units to vest, Grantee must, prior to the first Vesting
Date identified on the first page hereof under “Summary of Restricted Share Unit Award Grant”, (i) accept the Restricted Units online or by
telephone in accordance with the procedures established by the Company and Merrill Lynch, and; (ii) open a Merrill Lynch brokerage account
through the system maintained on behalf of the Company. If the Grantee has not completed both of the tasks prior to the first Vesting Date
identified on the first page hereof under “Summary of Restricted Share Unit Award Grant”, the Restricted Units shall be forfeited as of such date.
(c) In addition, in 2020 the Board adopted a compensation recoupment or “clawback” policy (the “Clawback Policy”)
applicable to all Company officers subject to Section 16 of the Exchange Act.
4. Payment.
(a) Except as otherwise provided in this Agreement, the Company shall deliver to the Grantee one share of its common
stock (“Share”) for each vested Restricted Unit within thirty (30) days following the earlier of:
(i)
the Vesting Date identified on the first page hereof under “Summary of Restricted Share Unit Award
Grant”;
(ii)
the date of the Grantee’s death;
(iii)
the date of the Grantee’s Disability, provided such Disability also constitutes a “disability” within the
meaning of Section 409A of the Code with respect to a Grantee whose Restricted Units are subject to
Section 409A of the Code; or
(iv)
the date of Grantee’s termination of employment with the Company as a result of Retirement, provided
such termination of employment also constitutes a “separation from service” within the meaning of
Section 409A of the Code with respect to a Grantee whose Restricted Units are subject to Section 409A of
the Code.
- 2 -
If the Grantee is a “specified employee” within the meaning of Section 409A of the Code on the date of the Grantee’s separation from service
and the Grantee’s Restricted Units are subject to Section 409A of the Code, then payment under (iv) above shall be made on the first day of the
seventh month following the Grantee’s separation from service, or, if earlier, the date of the Grantee’s death.
(b) The Company’s obligations with respect to the Restricted Units shall be satisfied in full upon the delivery of its
Shares pursuant to Section 4(a) herein.
5. Transferability. The Restricted Units may not be transferred and shall not be subject in any manner to assignment,
alienation, pledge, encumbrance or charge, until all restrictions are removed or have expired, unless otherwise provided under the Plan. Any
purported Transfer or encumbrance in violation of the provisions of this Section 5 shall be void, and the other party to any such purported
transaction shall not obtain any rights to or interest in such Restricted Units.
6. Voting and Other Rights. The Grantee will not have any rights of a shareholder of the Company with respect to the
Restricted Units until the delivery of the underlying Shares. The obligations of the Company under this Agreement will be merely that of an
unfunded and unsecured promise of the Company to deliver Shares in the future, and the rights of the Grantee will be no greater than that of an
unsecured general creditor. No assets of the Company will be held or set aside as security for the obligations of the Company under this
Agreement.
7. Dividend Equivalent Payment Rights. The Grantee shall possess no dividend equivalent payment rights with respect to the
Restricted Units granted pursuant to this Agreement as of the Grant Date.
8. Continuous Employment. Unless otherwise specified by the Plan, for purposes of this Agreement, the continuous
employment of the Grantee with the Company shall not be deemed to have been interrupted, and the Grantee shall not be deemed to have ceased
to be an employee of the Company, by reason of the transfer of his employment among the Company or a leave of absence approved by the
Committee.
9. No Employment Contract. Nothing contained in this Agreement shall confer upon the Grantee any right with respect to
continuance of employment by the Company, nor limit or affect in any manner the right of the Company to terminate the employment or adjust
the compensation of the Grantee.
10. Relation to Other Benefits. Any economic or other benefit to the Grantee under this Agreement or the Plan shall not be
taken into account in determining any benefits to which the Grantee may be entitled under any profit-sharing, retirement or other benefit or
compensation plan maintained by the Company and shall not affect the amount of any life insurance coverage available to any beneficiary under
any life insurance plan covering employees of the Company.
11. Taxes and Withholding. To the extent that the Company is required to withhold any federal, state, local, foreign or other
tax in connection with the Restricted Units pursuant to this Agreement, it shall be a condition to earning the award that the Grantee make
arrangements satisfactory to the Company for payment of such taxes required to be withheld. With respect to payments under Section 4 herein,
the Committee may, in its sole discretion, require the Grantee to satisfy such required withholding obligation by surrendering to the Company a
portion of the Shares earned by the Grantee hereunder, and the Shares so surrendered by the Grantee shall be credited
- 3 -
against any such withholding obligation at the Fair Market Value of such Shares on the date of surrender. Further, the Committee may accelerate
the payment of a portion of the Shares earned by the Grantee hereunder to pay the Federal Insurance Contributions Act (FICA) tax under
Sections 3101, 3121(a) and 3121(v)(2) of the Code and the corresponding income tax withholding related to the FICA amount.
12. Adjustments. The number and kind of Shares deliverable pursuant to a Restricted Unit are subject to adjustment as
provided in Section 12 of the Plan.
13. Compliance with Law. While the Company shall make reasonable efforts to comply with all applicable federal and state
securities laws and listing requirements with respect to the Restricted Units or Shares that may be delivered pursuant to Section 4 herein, the
Company shall not be obligated to deliver any Restricted Units or Shares pursuant to this Agreement if the delivery thereof would result in a
violation of any such law or listing requirement.
14. Amendments. Subject to the terms of the Plan, the Committee may modify this Agreement upon written notice to the
Grantee. Any amendment to the Plan shall be deemed to be an amendment to this Agreement to the extent that the amendment is applicable
hereto; provided, however, no amendment of the Plan or this Agreement shall adversely affect the rights of the Grantee under this Agreement
without the Grantee’s consent unless the Committee determines, in good faith, that such amendment is required for the Agreement to either be
exempt from the application of, or comply with, the requirements of Section 409A of the Code, or as otherwise may be provided in the Plan.
15. Section 409A of the Code. It is intended that the Restricted Units shall be exempt from the application of, or comply with,
the requirements of Section 409A of the Code. The terms of this Agreement shall be construed, administered, and governed in a manner that
effects such intent, and the Committee shall not take any action that would be inconsistent with such intent. Without limiting the foregoing, the
Restricted Units shall not be deferred, accelerated, extended, paid out, settled, adjusted, substituted, exchanged or modified in a manner that
would cause the award to fail to satisfy the conditions of an applicable exception from the requirements of Section 409A of the Code or
otherwise would subject the Grantee to the additional tax imposed under Section 409A of the Code.
16. Severability. In the event that one or more of the provisions of this Agreement shall be invalidated for any reason by a
court of competent jurisdiction, any provision so invalidated shall be deemed to be separable from the other provisions hereof, and the remaining
provisions hereof shall continue to be valid and fully enforceable.
17. Relation to Plan. This Agreement is subject to the terms and conditions of the Plan. This Agreement and the Plan contain
the entire agreement and understanding of the parties with respect to the subject matter contained in this Agreement, and supersede all prior
written or oral communications, representations and negotiations in respect thereto. In the event of any inconsistency between the provisions of
this Agreement and the Plan, the Plan shall govern except with respect to Section 2(a) of this Agreement. Capitalized terms used herein without
definition shall have the meanings assigned to them in the Plan. The Committee acting pursuant to the Plan, as constituted from time to time,
shall, except as expressly provided otherwise herein, have the right to determine any questions which arise in connection with the grant of the
Restricted Units.
- 4 -
18. Successors and Assigns. Without limiting Section 5, the provisions of this Agreement shall inure to the benefit of, and be
binding upon, the successors, administrators, heirs, legal representatives and assigns of the Grantee, and the successors and assigns of the
Company.
19. No Advice Regarding Award. The Company is not providing any tax, legal or financial advice, nor is the Company
making any recommendations regarding the Grantee’s participation in the Plan or the acquisition or sale of the underlying securities. The Grantee
is hereby advised to consult with the Grantee’s personal tax, legal or financial advisors regarding the decision to participate in the Plan before
taking any action related to the Plan.
20. Governing Law.
(a) The interpretation, performance, and enforcement of this Agreement, including tort claims, shall be governed by the
laws of the State of Ohio, without giving effect to the principles of conflict of laws thereof.
(b) Any party bringing a legal action or proceeding against another party arising out of or relating to this Agreement
may bring the legal action or proceeding only in the United States District Court for the Southern District of Ohio and any of the courts of the
State of Ohio, in each case sitting in Cincinnati, Ohio.
(c) Each of the Company and the Grantee waives, to the fullest extent permitted by law, (i) any objection which it may
now or later have to the laying of venue of any legal action or proceeding arising out of or relating to this Agreement brought in any court of the
State of Ohio sitting in Cincinnati, Ohio or the United States District Court for the Southern District of Ohio sitting in Cincinnati, Ohio,
including, without limitation, a motion to dismiss on the grounds of forum non conveniens or lack of subject matter jurisdiction; and (ii) any
claim that any action or proceeding brought in any such court has been brought in an inconvenient forum.
(d) Each of the Company and the Grantee submits to the exclusive jurisdiction (both personal and subject matter) of
(i) the United States District Court for the Southern District of Ohio sitting in Cincinnati, Ohio and its appellate courts, and (ii) any court of the
State of Ohio sitting in Cincinnati, Ohio and its appellate courts, for the purposes of all legal actions and proceedings arising out of or related to
this Agreement.
21. Language. If the Grantee receives this Agreement or any other document related to the Plan translated into a language other
than English and if the meaning of the translated version is different than the English version, the English version will control.
22. Electronic Delivery. The Grantee hereby consents and agrees to electronic delivery of any documents that the Company
may elect to deliver (including, but not limited to, prospectuses, prospectus supplements, grant or award notifications and agreements, account
statements, annual and quarterly reports, and all other forms of communications) in connection with this and any other award made or offered
under the Plan. The Grantee understands that, unless earlier revoked by the Grantee by giving written notice to the Secretary of the Company,
this consent shall be effective for the duration of the Agreement. The Grantee also understands that he or she shall have the right at any time to
request that the Company deliver written copies of any and all materials referred to above at no charge. The Grantee hereby consents to any and
all procedures the Company has established or may establish for an electronic signature system for delivery and acceptance of any such
documents that the Company may
- 5 -
elect to deliver, and agrees that his or her electronic signature is the same as, and shall have the same force and effect as, his or her manual
signature. The Grantee consents and agrees that any such procedures and delivery may be effected by a third party engaged by the Company to
provide administrative services related to the Plan.
IN WITNESS WHEREOF, the Company has caused this Agreement to be executed on its behalf by its duly authorized officer and
the Grantee has also executed this Agreement, as of the Grant Date.
MERIDIAN BIOSCIENCE, INC.
By:
Name: Bryan T. Baldasare
Title: Chief Financial Officer
You must accept the award online or by telephone in accordance with the procedures established by the Company and the Plan administrator. By
accepting your award in accordance with these procedures, you acknowledge that a copy of the Plan, Plan Summary and Prospectus, and the
Company’s most recent Annual Report and Proxy Statement (the “Prospectus Information”) either have been received by you or are available for
viewing on the Company’s intranet site or internet site at www.meridianbioscience.com, and consent to receiving this Prospectus Information
electronically, or, in the alternative, agree to contact Julie Smith at (513) 272-5230 to request a paper copy of the Prospectus Information at no
charge. You also represent that you are familiar with the terms and provisions of the Prospectus Information and hereby accept the award on the
terms and conditions set forth herein and in the Plan. These terms and conditions constitute a legal contract that will bind both you and the
Company as soon as you accept the award as described above.
- 6 -
APPENDIX A
Notwithstanding anything to the contrary in Section 2, in the event of a Change in Control, unless the successor company, or a parent of the
successor company in the Change in Control agrees to assume, replace, or substitute the Restricted Units granted hereunder (as of the
consummation of such Change in Control) with Restricted Units on substantially identical terms, as determined by the Committee, if the
Grantee’s employment with the Company or its Affiliates (or any successor thereto) is terminated within twenty-four(24) months following a
Change in Control either (x) by the Company or its Affiliates (or any successor thereto) without Cause (as defined in the Plan) or (y) by the
Grantee with Good Reason, the Restricted Units granted hereunder shall become vested in their entirety as of the date of such termination and
payment shall be made within thirty days following vesting. As used herein, “Good Reason” shall mean the occurrence of any of the following:
(i) a material diminution in the Grantee’s authority, duties or responsibilities; (ii) a material diminution in the Grantee’s annual base salary as in
effect on the date of this Agreement or as the same may be increased from time to time; (iii) the Company fails to pay or provide any amount or
benefit that the Company is obligated to pay or provide under this Agreement or any other employment, compensation, benefit or reimbursement
plan, agreement or arrangement of the Company to which the Grantee is a party or in which the Grantee participates; (iv) the relocation of the
Grantee’s principal place of employment to a location which increases the Grantee’s one-way commuting distance by more than 50 miles, or the
Company’s requiring the Grantee to travel on business other than to an extent substantially consistent with the Grantee’s business travel
obligations prior to the Change in Control; (v) a significant adverse change occurs, whether of a quantitative or qualitative nature, in the
indemnification protection provided to the Grantee for acts and omissions arising out of his service on behalf of the Company or any other entity
at the request of the Company; or (vi) the Company fails to obtain the assumption of this Agreement.
- 7 -
APPENDIX B
Internal Revenue Code Section 409A
These Restricted Units are designed to be exempt from, or comply with, the provisions of Internal Revenue Code Section 409A. If the Restricted
Units are subject to Section 409A, there may be limitations with respect to the timing of the delivery of shares in certain situations (Retirement,
Disability, Change in Control along with an involuntary termination of employment) as noted above in Section 4. Payment. In addition, if
Section 409A applies, there is a six month waiting period before the shares can be delivered to certain high level employees on account of
Retirement or a Change in Control along with an involuntary termination of employment.
Key terms related to this section of the Code are defined below.
Separation from Service
In general, a separation from service occurs when there is no longer any employment or consulting relationship between the employee and Meridian.
Specified Employee
In simplified terms, this includes employees who are Officers of Meridian Bioscience, Inc. and have annual compensation of greater than $185,000
(as adjusted from time to time). Additionally, this includes employees who own more than 1% of the Company and have annual compensation of
greater than $150,000.
This discussion of Section 409A and certain key terms is only a summary and is not a part of the Agreement or the Plan. If you have any
questions regarding these provisions please contact Bryan Baldasare.
10540839.6
- 8 -
Exhibit 10.8
MERIDIAN BIOSCIENCE, INC.
2021 OMNIBUS AWARD PLAN
NONQUALIFIED STOCK OPTION AGREEMENT
Summary of Nonqualified Stock Option Grant
Meridian Bioscience, Inc., an Ohio corporation (the “Company”), grants to the Grantee named below, in accordance with the terms
of the Meridian Bioscience, Inc. 2021 Omnibus Award Plan, a copy of which is available on the Bank of America Merrill Lynch website at
www.benefits.ml.com (the “Plan”) and this Nonqualified Stock Option Agreement (the “Agreement”), an option to purchase shares of the
Common Stock of the Company (“Shares”) at an exercise price per Share as described below:
Name of Grantee:
Number of Underlying Shares:
Exercise Price Per Share:
$18.88
Grant Date:
November 4, 2021
Vesting Date(s):
25% November 4, 2022
75% pro-rata on a monthly basis
beginning December 4, 2022 and
ending November 4, 2025 (For a
complete vesting schedule, see
Appendix B attached)
Expiration Date:
November 4,
2031
Terms of Agreement
1. Grant of Nonqualified Stock Option. Subject to and upon the terms, conditions, and restrictions set forth in this Agreement
and in the Plan, the Company hereby grants to the Grantee as of the Grant Date, an option to purchase Shares of Common Stock of the Company
at an exercise price per Share as set forth above (the “Option”). It is the intent of the Company and the Grantee that the Option will not qualify
as an “incentive stock option” under Section 422 of the Internal Revenue Code of 1986, as amended from time to time.
2. Vesting of Option.
(a) Except as otherwise provided in this Agreement, the Option shall become exercisable according to the vesting
schedule set forth above. Prior to the Vesting Date, no portion of the award is vested except as otherwise provided in Section 2.
(b) The Option shall vest in full prior to the Vesting Date(s) upon the occurrence of any of the following: (i) the Grantee
dies while in the employ of the Company; (ii) the Grantee satisfies the requirements for Retirement, as defined in the Plan, including separation
from employment with the Company; or (iii) the Grantee has a Disability, as defined in the Plan. The Option shall be exercisable for ninety days
following the occurrence of the condition described in Section 2(b)(ii), unless the Grantee is required to file beneficial ownership reports under
Section 16 of the Exchange Act, in which case the Option shall be exercisable for one year following the occurrence of the condition described in
Section 2(b)(ii). The Option shall be exercisable for one year following the occurrence of the conditions described in Sections 2(b)(i) and 2(b)
(iii).
(c) The Committee may, in its sole discretion, accelerate the time at which the Option becomes vested and
non-forfeitable to a time other than the Vesting Date(s) as provided in Section 2(a) or to a time other than provided in Section (2)(b)(i), (ii), or
(iii) on such terms and conditions as it deems appropriate in accordance with the terms and conditions of the Plan.
(d) The extent to which the Option may vest upon a Change in Control is described on Appendix A attached hereto.
3. Forfeiture.
(a) Any portion of the Option that has not yet vested pursuant to Section 2 shall be forfeited automatically without
further action or notice if the Grantee ceases to be employed by the Company other than as provided in Section 2 hereof. In addition, in 2020
the Board adopted a compensation recoupment or “clawback” policy (the “Clawback Policy”) applicable to all Company officers subject to
Section 16 of the Exchange Act.
4. Exercise and Payment.
(a) The Option granted under this Agreement shall be exercisable on the Vesting Date(s) as provided on the first page
under “Summary of Nonqualified Stock Option Grant” herein or earlier as provided in Section 2. The Option granted under this Agreement may
not be exercised as to less than twenty-five (25) Shares at any time.
(b) The Option may be exercised for the number of Shares specified by Grantee’s delivery of instructions through and in
accordance with the procedures established under the Merrill Lynch system maintained on behalf of the Company, accompanied by full payment
in the manner and subject to the conditions set forth pursuant to the terms of the Plan for the number of Shares in respect of which it is exercised.
The Grantee may pay the Exercise Price by means of a broker-assisted “cashless exercise” pursuant to which the Company or Merrill Lynch, as
the case may be, is delivered a copy of irrevocable instructions to a stockbroker to sell Shares of Common Stock otherwise deliverable upon the
exercise of the Option and to deliver promptly to the Company an amount equal to the Exercise Price and/or the amount of any taxes described in
Section 10 below (“Broker-Assisted Cashless Exercise”). Any fractional Share of Common Stock may be settled in cash in a Broker-Assisted
Cashless Exercise.
(c) If any applicable law or regulation requires the Company to take any action with respect to the Shares specified in
such notice, or if any action remains to be taken under the Articles of Incorporation or Code of Regulations of the Company to effect due
issuance of the Shares, then the Company shall take such action and the day for delivery of such stock shall be extended for the period necessary
to take such action.
- 2 -
5. Transferability. The Option may not be transferred and shall not be subject in any manner to assignment, alienation, pledge,
encumbrance or charge, unless otherwise provided under the Plan. Any purported Transfer or encumbrance in violation of the provisions of this
Section 5 shall be void, and the other party to any such purported transaction shall not obtain any rights to or interest in the Option.
6. Voting and Other Rights. The Grantee will not have any rights of a shareholder of the Company with respect to the Option
until the Option is exercised.
7. Continuous Employment. Unless otherwise specified by the Plan, for purposes of this Agreement, the continuous
employment of the Grantee with the Company shall not be deemed to have been interrupted, and the Grantee shall not be deemed to have ceased
to be an employee of the Company, by reason of the transfer of his employment among the Company or a leave of absence approved by the
Committee.
8. No Employment Contract. Nothing contained in this Agreement shall confer upon the Grantee any right with respect to
continuance of employment by the Company, nor limit or affect in any manner the right of the Company to terminate the employment or adjust
the compensation of the Grantee.
9. Relation to Other Benefits. Any economic or other benefit to the Grantee under this Agreement or the Plan shall not be
taken into account in determining any benefits to which the Grantee may be entitled under any profit-sharing, retirement or other benefit or
compensation plan maintained by the Company unless required under the terms of such other plan, and shall not affect the amount of any life
insurance coverage available to any beneficiary under any life insurance plan covering employees of the Company.
10. Taxes and Withholding. By his or her acceptance of this Agreement, the Grantee agrees to reimburse the Company for any
taxes required by any government to be withheld or otherwise deducted and paid by the Company with respect to the issuance or disposition of
the Shares subject to the Option. In lieu thereof, the Company shall have the right to withhold the amount of such taxes from any other sums due
or to become due from the Company to the Grantee. The Company may, in its discretion, hold the stock certificate or certificates to which the
Grantee is entitled upon the exercise of the Option as security for the payment of such withholding tax liability, until cash sufficient to pay that
liability has been accumulated. In addition, at any time that the Company becomes subject to a withholding obligation under applicable law with
respect to the exercise of the Option (the “Tax Date”), except as set forth below, a holder of the Option may elect to satisfy, in whole or in part,
the holder’s related personal tax liabilities (an “Election”) by (a) directing the Company to withhold from Shares issuable in the related exercise
either a specified number of Shares or Shares having a specified value (in each case not in excess of the minimum required tax withholding
amount, (b) tendering Shares previously issued pursuant to the exercise of an Award or other Shares owned by the holder, (c) executing a
Broker-Assisted Cashless Exercise or (d) combining any or all of the foregoing Elections in any fashion. An Election shall be irrevocable. The
withheld Shares and other Shares tendered in payment shall be valued at their Fair Market Value on the Tax Date. The Committee may
disapprove of any Election, suspend or terminate the right to make Elections or provide that the right to make Elections shall not apply to
particular Shares or exercises. The Committee may impose any additional conditions or restrictions on the right to make an Election as it shall
deem appropriate, including any limitations necessary to comply with Section 16 of the Exchange Act.
- 3 -
11. Adjustments. The number and kind of Shares deliverable pursuant to the Option are subject to adjustment as provided in
Section 12 of the Plan.
12. Compliance with Law. While the Company shall make reasonable efforts to comply with all applicable federal and state
securities laws and listing requirements with respect to the Shares that may be delivered pursuant hereto, the Company shall not be obligated to
deliver any Shares pursuant to this Agreement if the delivery thereof would result in a violation of any such law or listing requirement.
13. Amendments. Subject to the terms of the Plan, the Committee may modify this Agreement upon written notice to the
Grantee. Any amendment to the Plan shall be deemed to be an amendment to this Agreement to the extent that the amendment is applicable
hereto.
14. Severability. In the event that one or more of the provisions of this Agreement shall be invalidated for any reason by a
court of competent jurisdiction, any provision so invalidated shall be deemed to be separable from the other provisions hereof, and the remaining
provisions hereof shall continue to be valid and fully enforceable.
15. Relation to Plan. This Agreement is subject to the terms and conditions of the Plan. This Agreement and the Plan contain
the entire agreement and understanding of the parties with respect to the subject matter contained in this Agreement, and supersede all prior
written or oral communications, representations and negotiations in respect thereto. In the event of any inconsistency between the provisions of
this Agreement and the Plan, the Plan shall govern except with respect to Section 2(a) of this Agreement. Capitalized terms used herein without
definition shall have the meanings assigned to them in the Plan. The Committee acting pursuant to the Plan, as constituted from time to time,
shall, except as expressly provided otherwise herein, have the right to determine any questions which arise in connection with the grant of the
Option.
16. Successors and Assigns. Without limiting Section 5, the provisions of this Agreement shall inure to the benefit of, and be
binding upon, the successors, administrators, heirs, legal representatives and assigns of the Grantee, and the successors and assigns of the
Company.
17. No Advice Regarding Award. The Company is not providing any tax, legal or financial advice, nor is the Company
making any recommendations regarding the Grantee’s participation in the Plan or the acquisition or sale of the underlying securities. The Grantee
is hereby advised to consult with the Grantee’s personal tax, legal or financial advisors regarding the decision to participate in the Plan before
taking any action related to the Plan.
18. Governing Law.
(a) The interpretation, performance, and enforcement of this Agreement, including tort claims, shall be governed by the
laws of the State of Ohio, without giving effect to the principles of conflict of laws thereof.
(b) Any party bringing a legal action or proceeding against another party arising out of or relating to this Agreement may
bring the legal action or proceeding only in the United States District Court for the Southern District of Ohio and any of the courts of the State of
Ohio, in each case sitting in Cincinnati, Ohio.
- 4 -
(c) Each of the Company and the Grantee waives, to the fullest extent permitted by law, (i) any objection which it may
now or later have to the laying of venue of any legal action or proceeding arising out of or relating to this Agreement brought in any court of the
State of Ohio sitting in Cincinnati, Ohio or the United States District Court for the Southern District of Ohio sitting in Cincinnati, Ohio,
including, without limitation, a motion to dismiss on the grounds of forum non conveniens or lack of subject matter jurisdiction; and (ii) any
claim that any action or proceeding brought in any such court has been brought in an inconvenient forum.
(d) Each of the Company and the Grantee submits to the exclusive jurisdiction (both personal and subject matter) of
(i) the United States District Court for the Southern District of Ohio sitting in Cincinnati, Ohio and its appellate courts, and (ii) any court of the
State of Ohio sitting in Cincinnati, Ohio and its appellate courts, for the purposes of all legal actions and proceedings arising out of or related to
this Agreement.
19. Language. If the Grantee receives this Agreement or any other document related to the Plan translated into a language other
than English and if the meaning of the translated version is different than the English version, the English version will control.
20. Electronic Delivery. The Grantee hereby consents and agrees to electronic delivery of any documents that the Company may
elect to deliver (including, but not limited to, prospectuses, prospectus supplements, grant or award notifications and agreements, account
statements, annual and quarterly reports, and all other forms of communications) in connection with this and any other award made or offered
under the Plan. The Grantee understands that, unless earlier revoked by the Grantee by giving written notice to the Secretary of the Company,
this consent shall be effective for the duration of the Agreement. The Grantee also understands that he or she shall have the right at any time to
request that the Company deliver written copies of any and all materials referred to above at no charge. The Grantee hereby consents to any and
all procedures the Company has established or may establish for an electronic signature system for delivery and acceptance of any such
documents that the Company may elect to deliver, and agrees that his or her electronic signature is the same as, and shall have the same force and
effect as, his or her manual signature. The Grantee consents and agrees that any such procedures and delivery may be effected by a third party
engaged by the Company to provide administrative services related to the Plan.
[Remainder of page intentionally left blank; signature page follows.]
- 5 -
IN WITNESS WHEREOF, the Company has caused this Agreement to be executed on its behalf by its duly authorized officer and
the Grantee has also executed this Agreement, as of the Grant Date.
MERIDIAN BIOSCIENCE, INC.
By:
Name: Bryan T. Baldasare
Title: Chief Financial Officer
You may accept the award online or by telephone in accordance with the procedures established by the Company and the Plan administrator. By
accepting your award in accordance with these procedures, you acknowledge that a copy of the Plan, Plan Summary and Prospectus, and the
Company’s most recent Annual Report and Proxy Statement (the “Prospectus Information”) either have been received by you or are available for
viewing on the Company’s intranet site or internet site at www.meridianbioscience.com, and consent to receiving this Prospectus Information
electronically, or, in the alternative, agree to contact Julie Smith at (513) 272-5230 to request a paper copy of the Prospectus Information at no
charge. You also represent that you are familiar with the terms and provisions of the Prospectus Information and hereby accept the award on the
terms and conditions set forth herein and in the Plan. These terms and conditions constitute a legal contract that will bind both you and the
Company as soon as you accept the award as described above.
- 6 -
APPENDIX A
Notwithstanding anything to the contrary in Section 2, in the event of a Change in Control, unless the successor company, or a parent of the
successor company in the Change in Control agrees to assume, replace, or substitute the option granted hereunder (as of the consummation of
such Change in Control) with an option on substantially identical terms, as determined by the Committee, if the Grantee’s employment with the
Company or its Affiliates (or any successor thereto) is terminated within twenty-four(24) months following a Change in Control either (x) by the
Company or its Affiliates (or any successor thereto) without Cause (as defined in the Plan) or (y) by the Grantee with Good Reason, the option
granted hereunder shall become vested in its entirety and exercisable as of the date of such termination. As used herein, “Good Reason” shall
mean the occurrence of any of the following: (i) a material diminution in the Grantee’s authority, duties or responsibilities; (ii) a material
diminution in the Grantee’s annual base salary as in effect on the date of this Agreement or as the same may be increased from time to time;
(iii) the Company fails to pay or provide any amount or benefit that the Company is obligated to pay or provide under this Agreement or any
other employment, compensation, benefit or reimbursement plan, agreement or arrangement of the Company to which the Grantee is a party or in
which the Grantee participates; (iv) the relocation of the Grantee’s principal place of employment to a location which increases the Grantee’s
one-way commuting distance by more than 50 miles, or the Company’s requiring the Grantee to travel on business other than to an extent
substantially consistent with the Grantee’s business travel obligations prior to the Change in Control; (v) a significant adverse change occurs,
whether of a quantitative or qualitative nature, in the indemnification protection provided to the Grantee for acts and omissions arising out of his
service on behalf of the Company or any other entity at the request of the Company; or (vi) the Company fails to obtain the assumption of this
Agreement.
10538495.6
- 7 -
APPENDIX B
The complete vesting schedule is as follows:
Date
Percentage of Shares that will Vest
11/4/2022
25%
12/4/2022
2.0833%
1/4/2023
2.0833%
2/4/2023
2.0833%
3/4/2023
2.0833%
4/4/2023
2.0833%
5/4/2023
2.0833%
6/4/2023
2.0833%
7/4/2023
2.0833%
8/4/2023
2.0833%
9/4/2023
2.0833%
10/4/2023
2.0833%
11/4/2023
2.0833%
12/4/2023
2.0833%
1/4/2024
2.0833%
2/4/2024
2.0833%
3/4/2024
2.0833%
4/4/2024
2.0833%
5/4/2024
2.0833%
6/4/2024
2.0833%
7/4/2024
2.0833%
8/4/2024
2.0833%
9/4/2024
2.0833%
10/4/2024
2.0833%
11/4/2024
2.0833%
12/4/2024
2.0833%
1/4/2025
2.0833%
2/4/2025
2.0833%
3/4/2025
2.0833%
4/4/2025
2.0833%
5/4/2025
2.0833%
6/4/2025
2.0833%
7/4/2025
2.0833%
8/4/2025
2.0833%
9/4/2025
2.0833%
10/4/2025
2.0833%
11/4/2025
2.0845%
- 8 -
Exhibit 21
Subsidiaries of the Registrant
1.
Meridian Bioscience Corporation, an Ohio corporation
2.
Meridian Life Science, Inc., a Maine corporation
3.
Meridian Bioscience Europe, s.r.l., an Italian corporation
4.
Meridian Bioscience Europe S.A., a Belgian corporation
5.
Meridian Bioscience Europe B.V., a Dutch corporation
6.
Meridian Bioscience UK Ltd., a United Kingdom corporation
7.
Meridian Bioscience International Ltd., a United Kingdom corporation
8.
Meridian Bioscience Beijing, LLC, a Wholly Foreign Owned Enterprise located in Beijing, China
9.
Meridian Bioscience Canada, Inc., a Canadian corporation
10.
Meridian Bioscience Israel Holding Ltd, an Israeli corporation
11.
Bioline Ltd., a United Kingdom corporation
12.
Bioline Reagents Ltd., a United Kingdom corporation
13.
Bioline GmbH, a German corporation
14.
Bioline (Aust) Pty Ltd., an Australian corporation
15.
Magellan Biosciences, Inc., a Delaware corporation
16.
Magellan Diagnostics, Inc., a Delaware corporation
17.
Meridian Bioscience Israel Ltd., an Israeli corporation
18.
Jiangsu Exalenz Medical Device Co. Ltd., a Wholly Foreign Owned Enterprise located in China
Exhibit 23.1
Consent of Independent Registered Public Accounting Firm
We consent to the incorporation by reference in the following Registration Statements:
(1)
Registration Statement (Form S-8 No. 333-122554) pertaining to the 2004 Equity Compensation Plan of Meridian Bioscience, Inc.;
(2)
Registration Statement (Form S-8 No. 333-155703) pertaining to the 2004 Equity Compensation Plan (as Amended and Restated Through
January 22, 2008) of Meridian Bioscience, Inc.;
(3)
Registration Statement (Form S-8 No. 333-179440) pertaining to the 2012 Stock Incentive Plan of Meridian Bioscience, Inc.;
(4)
Registration Statement (Form S-8 No. 333-252538) pertaining to the 2021 Omnibus Award Plan of Meridian Bioscience Inc.; and
(5)
Registration Statement (Form S-3 File No. 333-250878) of Meridian Bioscience, Inc.;
of our reports dated November 23, 2021, with respect to the consolidated financial statements and schedule of Meridian Bioscience, Inc. and the
effectiveness of internal control over financial reporting of Meridian Bioscience, Inc. included in this Annual Report (Form 10-K) of Meridian Bioscience,
Inc. for the year ended September 30, 2021.
/s/ Ernst & Young LLP
Cincinnati, Ohio
November 23, 2021
Exhibit 23.2
Consent of Independent Registered Public Accounting Firm
We have issued our report dated November 23, 2020, with respect to the consolidated financial statements included in the Annual Report of Meridian
Bioscience, Inc. on Form 10-K for the year ended September 30, 2021. We consent to the incorporation by reference of said reports in the Registration
Statements of Meridian Bioscience, Inc. on Form S-3 (File No. 333-250878), and on Forms S-8 (File No. 333-179440, File No. 333-155703, File
No. 333-122554 and File No. 333-252538).
/s/ GRANT THORNTON LLP
Cincinnati, Ohio
November 23, 2021
Exhibit 31.1
Certification of Principal Executive Officer Pursuant to Securities Exchange Act Rule 13a-14(a)
I, Jack Kenny, certify that:
1.
I have reviewed this annual report on Form 10-K of Meridian Bioscience, Inc.;
2.
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the
statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this
report;
3.
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the
financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4.
The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in
Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and
15d-15(f)) for the registrant and have:
a)
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to
ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those
entities, particularly during the period in which this report is being prepared;
b)
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our
supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of the financial statements for
external purposes in accordance with generally accepted accounting principles;
c)
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the
effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d)
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent
fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to
materially affect, the registrant’s internal control over financial reporting; and
5.
The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the
registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
a)
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are
reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
b)
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal
control over financial reporting.
Date: November 23, 2021
/s/ Jack Kenny
Jack Kenny
Chief Executive Officer
Exhibit 31.2
Certification of Principal Financial Officer Pursuant to Securities Exchange Act Rule 13a-14(a)
I, Bryan T. Baldasare, certify that:
1.
I have reviewed this annual report on Form 10-K of Meridian Bioscience, Inc.;
2.
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the
statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this
report;
3.
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the
financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4.
The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in
Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and
15d-15(f)) for the registrant and have:
a)
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to
ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those
entities, particularly during the period in which this report is being prepared;
b)
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our
supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of the financial statements for
external purposes in accordance with generally accepted accounting principles;
c)
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the
effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d)
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent
fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to
materially affect, the registrant’s internal control over financial reporting; and
5.
The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the
registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
a)
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are
reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
b)
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal
control over financial reporting.
Date: November 23, 2021
/s/ Bryan T. Baldasare
Bryan T. Baldasare
Executive Vice President and
Chief Financial Officer
Exhibit 32
Certification of Chief Executive Officer and Chief Financial Officer
Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to
Section 906 of the Sarbanes-Oxley Act of 2002
In connection with the filing with the Securities and Exchange Commission of the Annual Report of Meridian Bioscience, Inc. (the “Company”) on Form
10-K for the period ended September 30, 2021 (the “Report”), the undersigned officers of the Company, certify, pursuant to 18 U.S.C. § 1350, as adopted
pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that to the best of their knowledge:
1.
The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
2.
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the
Company.
/s/ Jack Kenny
Jack Kenny
Chief Executive Officer
November 23, 2021
/s/ Bryan T. Baldasare
Bryan T. Baldasare
Executive Vice President and
Chief Financial Officer
November 23, 2021