This Annual Report on Form 10-K includes forward-looking statements about our business and results of operations that are subject to risks and
uncertainties. See Forward-Looking Statements above. Factors that could cause or contribute to such differences include those discussed in Item 1A. Risk Factors. In addition to the risk factors discussed herein, we are
also subject to additional risks and uncertainties not presently known to us or that we currently deem immaterial. If any of these risks and uncertainties develops into actual events, our business, financial condition or results of operations
could be adversely affected.
Unless the context requires otherwise, references in this Annual Report on Form 10-K to Meridian,
we, us, our, or our company refer to Meridian Bioscience, Inc. and its subsidiaries.
In the
discussion that follows, all dollars and shares are in thousands (both tables and text), except per share data.
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 test kits, primarily for certain gastrointestinal, viral, respiratory, and parasitic infectious diseases, and elevated blood lead levels; and
(ii) the manufacture and distribution of bulk antigens, antibodies, PCR/qPCR reagents, nucleotides, competent cells, and bioresearch reagents used by researchers and other diagnostic manufacturers. The Company was incorporated in Ohio in
1976. Our principal corporate offices are located near Cincinnati, Ohio, USA.
During March 2016, we acquired all of the outstanding common stock of
Magellan Biosciences, Inc., and its wholly-owned subsidiary Magellan Diagnostics, Inc. (collectively, Magellan), which is now reported as part of our Diagnostics operating segment. Headquartered near Boston, Massachusetts, Magellan
is a leading manufacturer of FDA-cleared products for the testing of blood to diagnose lead poisoning in children and adults. Magellan is the leading provider of point-of-care lead testing systems in the U.S.
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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 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 Securities and
Exchange Commission (SEC). These reports may also be read and copied at the SECs public reference room at 100 F Street, N.E., Washington, DC 20549, phone number 1-800-732-0330. 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 Annual Report on Form 10-K.
Reportable Segments
Our reportable segments are
Diagnostics and Life Science, both of which are headquartered in Cincinnati, Ohio, which also serves as the Diagnostics segments base of manufacturing operations and research and development for infectious disease products. The
Diagnostics segment consists of manufacturing operations in Cincinnati, Ohio, and the sale and distribution of diagnostic test kits in the countries comprising North, Central and South America (the Americas); Europe, Middle East and
Africa (EMEA); and other countries outside of the Americas and EMEA (rest of the world, or ROW). As previously noted, the Diagnostics segment includes the Companys recent acquisition of Magellan, which is located
in Billerica, Massachusetts (near Boston). Its facility includes research, development, manufacturing, marketing, sales, and distribution operations. The Life Science segment consists of manufacturing operations in Memphis, Tennessee; Boca
Raton, Florida; London, England; Luckenwalde, Germany; and Sydney, Australia, and the sale and distribution of bulk antigens, antibodies, PCR/qPCR reagents, nucleotides, competent cells, and bioresearch reagents domestically and abroad, including
sales and business development offices in Singapore and Beijing, China to further pursue growing revenue opportunities in Asia. Financial information for Meridians reportable segments is included in Note 8 to the consolidated financial
statements.
Diagnostics Segment
Overview of
Products and Markets
Our primary source of revenues continues to be diagnostic products, with our Diagnostics segment providing 74% of
consolidated net revenues for fiscal 2016. Third-party revenues for this segment were $145,000, $146,000 and $142,000 for fiscal 2016, 2015 and 2014, respectively. As of September 30, 2016, our Diagnostics segment had approximately 440
employees in seven countries.
Our diagnostic products provide accuracy, simplicity and speed; enable early diagnosis and treatment of common, 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 (iv) have difficult sample handling requirements (stool, blood, urine and other body fluids). This approach has allowed us to establish significant market share in our target
disease states.
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Our diagnostic products span a broad menu of testing platforms and technologies, and also include transport media
that store and preserve specimen samples from patient collection to laboratory testing. Our testing platforms include:
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Isothermal DNA Amplification
(
illumi
gene
brand)
high sensitivity, molecular platform that is suitable for virtually any size laboratory, whether centralized or decentralized;
provides flexibility to process from 1 to 10 tests per run in generally under one hour; and requires no batching of samples.
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Rapid Immunoassay (TRU, Immuno
Card
and Immuno
Card
STAT!
brands)
single-use immunoassays that can be used in point-of-care settings; have fast turnaround
times (generally under 20 minutes); and can reduce expensive send-outs for hospitals and outpatient clinics.
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Enzyme-linked Immunoassay (PREMIER
brand)
batch immunoassay platform that can process up to 96 tests per run; is highly accurate and economical; and is adaptable to automation.
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Anodic Stripping Voltammetry (LeadCare
brand)
electrical chemical sensor platform for quantitative determination of lead levels in blood.
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Our diagnostic products are used principally in the detection of infectious diseases caused by various bacteria, viruses, parasites and pathogens, including
most notably the following general areas:
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C. difficile
causative agent for antibiotic-associated diarrhea from a hospital-acquired infection
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Foodborne
Enterohemorrhagic
E. coli
(EHEC) and
Campylobacter jejuni
(Campy)
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H. pylori
stomach ulcers
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Respiratory
Group A
Streptococcus
,
M. pneumoniae
(Mycoplasma) and
Bordetella pertussis
, among tests for other diseases
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Womens Health & Sexually Transmitted Diseases (STD)
Group B
Streptococcus
,
Chlamydia trachomatis
,
Neisseria gonorrhea
, Herpes Simplex Virus Type 1 & Type 2
|
Our diagnostics products also include Magellans LeadCare brand of tests for quantitative determination of blood lead levels.
Our product portfolio includes over 140 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.
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We continue to invest in new product development for our molecular testing platform,
illumi
gene
. This platform now has the following commercialized tests (assays):
|
1.
|
illumi
gene C. difficile
commercialized in August 2010
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2.
|
illumi
gene
Group B
Streptococcus
(Group B Strep or GBS) commercialized in December 2011
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3.
|
illumi
gene
Group A
Streptococcus
(Group A Strep) commercialized in September 2012
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4.
|
illumi
gene
Mycoplasma (
M. pneumoniae;
walking pneumonia) commercialized in June 2013
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5.
|
illumi
gene Bordetella pertussis
(whooping cough) commercialized in March 2014
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6.
|
illumi
gene Chlamydia trachomatis
commercialized outside of U.S. in February 2015
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7.
|
illumi
gene Neisseria gonorrhea
commercialized outside of U.S. in February 2015
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|
8.
|
illumi
gene
HSV 1&2 (Herpes Simplex Virus Type 1 & Type 2) commercialized in July 2015
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9.
|
illumi
gene
Malaria commercialized outside of U.S. in February 2016
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10.
|
illumi
gene
Mycoplasma Direct (
M. pneumoniae;
walking pneumonia) commercialized in June 2016
|
We have several additional
illumi
gene
tests in development, a robust pipeline of
illumi
gene
opportunities and a plan
to continue adding new assays to our
illumi
gene
platform menu.
We believe that our
illumi
gene
system has been
well-accepted in our global markets. We now have over 1,500 customer account placements. Of these account placements, approximately 1,300 accounts have completed evaluations and validations and are regularly purchasing product, with the
balance of our account placements being in some stage of product evaluation and/or validation. Of our account placements, we have nearly 450 accounts that are regularly purchasing, evaluating and/or validating two or more assays.
Market Trends
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. More importantly, within this market, there is a continuing shift from
conventional testing, which requires highly trained personnel and lengthy turnaround times for test results, to more technologically advanced testing, which can be performed by less highly trained personnel and completed in minutes or hours.
The increasing global pressures to contain total health care costs have accelerated the increased use of diagnostic testing. With rapid and accurate
diagnoses of infectious diseases, physicians can pinpoint appropriate therapies quickly, leading to faster recovery, shorter hospital stays and lower overall treatment cost. Integrated Delivery Networks (IDNs) and Accountable Care Organizations
(ACOs) 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, ACOs and health care systems that
are transitioning from fee-for-service compensation models, to value based reimbursement. Our
C. difficile
, Group B
Streptococcus
, Group A
Streptococcus
and
H. pylori
products are all examples of how a highly accurate
diagnostic test on the front end can mitigate or reduce down-stream costs for antibiotic use, symptom-relieving drugs and hospital stays.
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We also continue to see aggregation of buying power in our U.S. market via multi-hospital group purchasing
organizations and integrated delivery networks, consolidation among reference laboratories, and acquisition of physician practices by hospitals, health systems, and for-profit specialty health care companies. We utilize multi-year supply agreements
to secure our business where we deem appropriate.
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
segments sales and distribution network consists of the following for each of the broad geographic regions we serve:
North
America
In North America, our sales and distribution network consists of a direct sales force (U.S. only) complemented by independent
distributors. The use of independent distributors in the U.S. allows our products to reach any size health care facility and also provides our customers the option to purchase our products directly from Meridian or through an authorized
distributor. Two independent distributors in the U.S. accounted for 10% or more of consolidated net revenues in fiscal 2016, 2015 and 2014: Cardinal Healthcare Corporation and Thermo Fisher Scientific. Our revenues from Cardinal were
approximately $20,000, $29,000 and $28,000 during fiscal 2016, 2015 and 2014, respectively. Our revenues from Thermo Fisher were approximately $20,000, $25,000 and $23,000 during fiscal 2016, 2015 and 2014, respectively.
EMEA
In EMEA, our sales
and distribution network consists of direct sales forces in Belgium, France, Holland and Italy, and independent distributors in other European countries, Africa and the Middle East. We have implemented a direct sales presence in Germany and the
U.K. for our
illumi
gene
products, and utilize independent distributors for our immunoassay products. We maintain a distribution center near Milan, Italy.
ROW
With the exception
of Australia, where we utilize a direct sales force, we utilize independent distributors throughout the ROW.
- 9 -
Competition
Our major competitors in molecular diagnostics are Cepheid and Becton Dickinson, who have systems with multiple-assay menus. We also face competition in
molecular diagnostics, but to a lesser degree, from companies such as Alere, Great Basin, Nanosphere and Quidel. These latter companies have a limited commercial menu and tend to compete strictly on price. We believe that our molecular
platform offers a number of competitive features:
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Molecular assay sensitivity that is comparable to higher costing PCR;
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Low capital investment with no instrument service cost;
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Small footprint that is portable and does not consume much laboratory space; and
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Product menu that fits with initiatives to improve clinical and economic outcomes.
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Our major competitors in
rapid immunoassay diagnostics are primarily Alere and Quidel. These companies tend to compete strictly on price. 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 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. We believe that with the breadth and depth of our product portfolio, we are well positioned for the clinical laboratory.
Research and Development
Our Diagnostics
segments research and development organization for infectious disease products is located at our corporate headquarters in Newtown, Ohio, a suburb of Cincinnati, and has expertise in biochemistry, immunology, mycology, bacteriology, virology,
parasitology, and molecular biology. Our Magellan business has a dedicated research and development team in Billerica, Massachusetts. Research and development expenses for the Diagnostics segment for fiscal 2016, 2015 and 2014 were
approximately $11,000, $10,000 and $10,000, respectively. 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. 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
illumi
gene
molecular platform,
H. pylori
product family and blood lead testing family were developed solely in-house, or substantially so.
Manufacturing
Our immunoassay and molecular
products require the production of highly specific and sensitive antigens, antibodies, primers and enzymes. While we produce substantially all of our own requirements including monoclonal and polyclonal antibodies, and a variety of fungal,
bacterial and viral antigens, currently a number of the raw materials used in our products, including our
illumi
gene
molecular products, are purchased from outside vendors. With the expansion of our molecular diagnostic
manufacturing capacity at our Cincinnati, Ohio location in recent years, we brought in-house certain molecular component manufacturing that was previously outsourced. Our blood lead testing products require the production of electrical chemical
sensors, for which we produce all of our own requirements. We believe that we have sufficient manufacturing and sourcing capacity for anticipated growth over the next several years.
- 10 -
Intellectual Property, Patents and Licenses
We own or license U.S. and foreign patents, most of which are for selected products manufactured by our Diagnostics segment. These patents are used in our
manufacturing processes for selected products (method patents) or may relate to the design of the test device technology format (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 for our
illumi
gene
products, which represented 20% and 21% of consolidated revenues for fiscal 2016 and fiscal 2015,
respectively, are licensed from a third party, Eiken Chemical Co., Ltd., under a non-exclusive license agreement and expire between 2020 and 2022. These patents were issued in the U.S., European Community and other countries. The term
of our license agreement runs until the last patent expires in 2022, at which point we will be free to practice the patents without any restriction or royalty obligation.
The patents for our
H. pylori
products, which represented 15% and 14% of consolidated revenues for fiscal 2016 and fiscal 2015, respectively, are
owned by us and expired in May 2016 in the U.S., and will expire in fiscal 2017 in countries outside the U.S. We expect competition with respect to our
H. pylori
products to increase in fiscal 2017 as we currently market the only
FDA-cleared tests to detect
H. pylori
antigen in stool samples. Such competition may have an adverse impact on our selling prices for these products or our ability to retain business at prices acceptable to us, and consequently,
adversely affect our future results of operations and liquidity, including revenues and gross profit. In order to mitigate competition, our product development pipeline includes multiple new product initiatives for the detection of
H.
pylori
. We are unable to provide assurances that we will be successful with any mitigation strategy or that any mitigation strategy will prevent an adverse effect on our future results of operations and liquidity, including revenues and
gross profit.
Government Regulation
Our
diagnostic products are regulated by the Food & Drug Administration (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 from the FDA as to safety and
effectiveness.
- 11 -
Each of the diagnostic products currently marketed by us in the United States has been cleared by the FDA
pursuant to the 510(k) clearance process or is exempt from such requirements. We believe that most, but not all, 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. Meridians TRU FLU rapid influenza assay was cleared in 2006 as a Class I device. In May 2014, the FDA proposed reclassifying
rapid influenza assays as a Class II device, requiring the submission of a new 510(k) application and subjecting TRU FLU and similar competitive devices to increased requirements for sensitivity. If the proposed rule becomes effective, Meridian
will have one year to bring its assay up to the new requirements or remove it from the market. Sales of the TRU FLU product totaled approximately $1,000 in fiscal 2016.
Sales of our diagnostic products in foreign countries are subject to foreign government regulation, largely similar to that of the FDA.
Meridians Cincinnati manufacturing facility is certified to ISO 13485:2012, and the Magellan facility in Billerica, Massachusetts is certified to ISO
9001:2008 and ISO 13485:2003.
Medical Device Tax
On January 1, 2013, the medical device tax established as part of the U.S. health care reform legislation became effective and as a result, the Company made
its first required tax deposit near the end of January 2013. During fiscal 2016, 2015 and 2014, the Company recorded to cost of sales approximately $500, $1,900 and $1,750, respectively, of medical device tax expense related to this
legislation. During December 2015, the Consolidations Appropriations Act of 2016 imposed a two-year moratorium on this excise tax effective January 1, 2016. During calendar years 2016 and 2017, this moratorium would result in approximately
$2,000 of savings each year. We are unable to predict any future legislative changes or developments related to this moratorium or excise tax.
Seasonal Factors and Sporadic Outbreaks
Our
principal business is the sale of a broad range of diagnostic test kits for common gastrointestinal, viral, upper respiratory, and parasitic 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 the H1N1 influenza outbreak during fiscal 2009. While we believe that the breadth of our diagnostic product lines reduces the risk
that infections subject to seasonality and sporadic outbreaks will cause significant variability in diagnostic revenues, we can make no assurance that revenues will not be impacted period over period by such factors.
- 12 -
Life Science Segment
Overview of Products and Markets
Our Life Science
segments business focuses on the development, manufacture, sale and distribution of bulk antigens, antibodies, PCR/qPCR reagents, nucleotides, competent cells and bioresearch reagents used by researchers, agri-bio companies and other
diagnostic manufacturing companies. Third-party revenues for this segment were approximately $51,000, $49,000 and $47,000 for fiscal 2016, 2015 and 2014, respectively. As of September 30, 2016, our Life Science segment had approximately
210 employees in seven countries.
Most of the revenues for our Life Science segment currently come from the manufacture, sale and distribution of bulk
antigens, antibodies, PCR/qPCR reagents, nucleotides, competent cells and bioresearch reagents used by researchers and other diagnostic manufacturing companies focused on the development of immunoassay and molecular tests. Approximately 65% of
Life Science revenues are generated from the industrial market, defined as diagnostic manufacturers and the agriculture industry. This continues to be an increasing focus of our Bioline molecular component business, which historically focused
on the academic/research market that comprises the remaining 35% of Life Science revenues. We utilize direct sales teams in key countries such as the U.S., the U.K., Germany, France, Australia and Singapore. Opened in 2013, the Singapore
sales and business development office is designed to increase our presence and our revenue opportunities in Asia for both molecular and immunoassay components. Additionally, in order to further pursue revenue opportunities in Asia, and China in
particular, during fiscal 2015 we opened a representative office in Beijing, China. We utilize a network of distributors in other major countries. During fiscal 2016, 18% of third-party revenues for this segment were from two diagnostic
manufacturing customers.
Products such as antibodies, antigens and reagents are marketed primarily to diagnostic manufacturing customers as a source of
raw materials for their immunoassay products, or as an outsourced step in their manufacturing processes. For example, we supply a number of major diagnostic manufacturers with proteins used to detect hepatitis A and rubella. These products
are typically sold in bulk quantities, and may also be custom-designed for a particular manufacturers requirements. Sales efforts are focused on multi-year supply arrangements in order to provide stability in volumes and pricing. We
believe this benefits both us and our customers.
Molecular biology products such as PCR/qPCR reagents, nucleotides and competent cells are marketed to
academic/research and industrial customers. These products are used in measuring DNA and RNA in clinical and agricultural applications. These reagents improve the purity, yield and speed of PCR reactions. Products such as MyTaq
and SensiFAST
are examples of this type of PCR/qPCR reagent.
- 13 -
Market Trends
As certain global markets become increasingly accessible to us, most notably China, geographic expansion continues to be a significant strategy for our Life
Science segment, along with further penetration into industrial markets with our molecular products.
Competition
The market for bulk biomedical reagents is highly competitive. Important competitive factors include product quality, price, customer service and
reputation. We face competitors, many of which have greater financial, research and development, sales and marketing, and manufacturing resources, and where sole-source supply arrangements do not exist. Customers also may choose to
manufacture their biomedical reagents in-house rather than purchase from outside vendors such as Meridian.
The academic/research market is highly
fragmented. Individual purchases are typically of small quantities. The breadth of product offerings, quality, price and service, including on-line capabilities and technical resources, are important factors to building customer loyalty
and repeat purchases.
Research and Development
Research and development expenses for our Life Science segment for each of fiscal 2016, 2015 and 2014 were approximately $3,000. The primary focus of this
research and development organization is development of new molecular reagent products.
Manufacturing and Government Regulation
Our Life Science U.S. facilities are ISO 9001:2008 certified and our Bioline facilities in the U.K. and Germany are ISO 13485:2012
certified. Additionally, where appropriate, our Life Science facilities comply with Regulation EC 1069:2009.
Acquisitions
Acquisitions have played an important role in the growth of our businesses. Our acquisition objectives include, among other things: (i) enhancing product
offerings; (ii) improving product distribution capabilities; (iii) providing access to new markets; and/or (iv) providing access to key biologicals or new technologies that lead to new products. Although we cannot provide assurance that we will
consummate additional acquisitions in the future, nor can we provide assurance that any acquisitions will accomplish these objectives, we expect that the potential for acquisitions will continue to provide opportunities for revenue and earnings
growth in the future.
As previously noted in the Overview section, during March 2016, we acquired all of the outstanding common stock of
Magellan. Headquartered near Boston, Massachusetts, Magellan is a leading manufacturer of FDA-cleared products for the testing of blood to diagnose lead poisoning in children and adults. Magellan is the leading provider of point-of-care
lead testing systems in the U.S.
- 14 -
International Markets
International markets are an important source of revenues and future growth opportunities for both of our segments. For both segments combined, revenues
from customers located outside of the Americas approximated $52,000 or 26% of consolidated fiscal 2016 revenues, $49,000 or 25% of consolidated fiscal 2015 revenues, and $55,000 or 29% of consolidated fiscal 2014 revenues. We expect to continue
to look to international markets as a source of revenue growth in the future.
During fiscal 2016, currency exchange had an approximate $1,700 unfavorable
impact on revenues; $700 within the Diagnostics segment and $1,000 within the Life Science segment. This compares to currency exchange rates having an approximate $4,700 unfavorable impact on revenues in fiscal 2015; $3,200 within the
Diagnostics segment and $1,500 within the Life Science segment. Due to natural hedge relationships with expenses, both cost of sales and operating expenses, the overall impact of exchange rate fluctuations on net earnings was not significant
during fiscal 2016, 2015 or 2014.
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.
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.
Risks Affecting Growth and Profitability of our Business
We may be unable to develop new products and services or acquire products and services 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.
- 15 -
In addition, we must regularly allocate considerable resources to research and development of new products,
services and technologies. The research and development process generally takes a significant amount of time from design stage 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 product in which we have invested substantial resources.
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, and financial risks of additional operating costs. 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.
Revenues for our Diagnostics segment may be impacted by our reliance upon two key distributors in North America, seasonal factors and sporadic
outbreaks, and changing diagnostic market conditions.
Key Distributors
Our Diagnostics segments revenues from sales through two U.S. distributors were 27% and 37%, respectively, of the Diagnostics segments total
revenues for fiscal 2016 and fiscal 2015, or 20% and 28%, respectively, of our consolidated revenues for fiscal 2016 and fiscal 2015. These parties distribute our products and other laboratory products to end-user customers. The loss of either
of these distributors could negatively impact our revenues and results of operations unless suitable alternatives were timely found or lost sales to one distributor were absorbed by another distributor. Finding a suitable alternative on
satisfactory terms may pose challenges in our industrys 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, but would not
necessarily result in lower net income levels.
- 16 -
In addition, buying patterns of these two distributors 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, viral, upper respiratory, and parasitic 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 H1N1 influenza. While we believe that
the breadth of our diagnostic product lines reduces the risk that infections subject to seasonality and sporadic outbreaks will cause significant variability in diagnostic revenues, we can make no assurance that revenues will not be negatively
impacted period over period by such factors.
Changing Diagnostic Market Conditions
Changes in the U.S. health care delivery system have resulted in consolidation among 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 integrated delivery networks (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 IDNs, which could adversely affect our results of operations.
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. Although to date, we have not seen any significant effect on the reimbursement rates for our products, if
reimbursement amounts for diagnostic testing services are decreased 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 revenues and/or results of operations.
In addition, on January 1, 2013, the medical device tax
established as part of the U.S. health care reform legislation became effective and as a result, the Company made its first required tax deposit near the end of January 2013. During fiscal 2016, 2015 and 2014, the Company recorded approximately
$500, $1,900 and $1,750, respectively, of Medical Device Tax expense, which is reflected as a component of cost of sales in the accompanying Consolidated Statements of Operations. During December 2015, the Consolidations Appropriations Act of
2016 imposed a two-year moratorium on this excise tax effective January 1, 2016. During calendar years 2016 and 2017, this moratorium would result in approximately $2,000 of savings each year. We are unable to predict any future
legislative changes or developments related to this moratorium or excise tax.
- 17 -
Efforts to reduce the U.S. federal deficit could adversely affect our results of operations.
As part of the Budget Control Act passed in August 2011 to extend the federal debt limit and reduce government spending, $1.2 trillion in automatic spending
cuts (known as sequestration) were implemented in 2013. The sequestration requires a 2% cut in Medicare payments for all services, including our diagnostic tests, which, due to subsequent legislative amendments to the statute, will remain in
effect through 2024 unless Congressional action is otherwise taken. Government research funding has also been reduced as a result of the sequestration. On January 2, 2013, the American Taxpayer Relief Act of 2012 also was signed into law,
which, among other things, further reduces Medicare payments to providers such as hospitals, imaging centers and cancer treatment centers, and increases the statute of limitations period for the government to recover overpayments to providers from
three to five years.
Such reductions in government health care spending or research funding 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 business.
Revenues for our Life Science segment may be impacted by customer concentrations and buying patterns.
Our Life Science segments revenues from sales of purified antigens and reagents to two diagnostic manufacturing customers were 18% and 16% of the Life
Science segments total revenues for fiscal 2016 and fiscal 2015, respectively; and 5% and 4% of our consolidated revenues for fiscal 2016 and fiscal 2015, respectively. Our Life Science segment has four other significant customers who
purchase antigens, antibodies and reagents, which together comprised 8% and 10% of the segments total revenues for fiscal 2016 and fiscal 2015, respectively. Any significant alteration of buying patterns from these customers could
adversely affect our period over period revenues and results of operations.
Intense competition could adversely affect our profitability.
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.
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We may face increased competition resulting from expiration of our H. pylori patents.
The patents for our
H. pylori
products are owned by us and expired in May 2016 in the U.S., and will expire in fiscal 2017 in countries outside the
U.S. We expect competition with respect to our
H. pylori
products to increase in fiscal 2017 as we currently market the only FDA-cleared tests to detect
H. pylori
antigen in stool samples. Such competition may have an adverse
impact on our selling prices for these products, or our ability to retain business at prices acceptable to us, and consequently, adversely affect our future results of operations and liquidity, including revenues and gross profit. In order to
mitigate any loss in revenues, among other things, we are researching and experimenting with new products and attempting to secure significant customers under long-term contracts. We are unable to provide assurances that we will be successful with
any mitigation strategy or that any mitigation strategy will prevent an adverse effect on our future results of operations and liquidity, including revenues and gross profit.
We depend on international revenues, and our financial results may be adversely impacted by foreign currency, regulatory or other developments affecting
international markets.
We sell products and services into approximately 70 countries. Approximately 26% and 25% of our net revenues for
fiscal 2016 and 2015, respectively, were attributable to markets outside of the Americas. For fiscal 2016, approximately 35% of our international revenues were from sales made in Euros and 40% were from sales made in U.S. dollars, with the remaining
25% primarily being a combination of sales made in British pounds, Australian dollars and Singapore dollars. We are subject to the risks associated with fluctuations in the exchange rates for the Australian dollar, British pound, Euro and
Singapore dollar to the U.S. dollar. We are also subject to other risks associated with international operations, including longer customer payment cycles, tariff regulations, requirements for export licenses, instability of foreign
governments, and governmental requirements with respect to the importation and distribution of medical devices and immunodiagnostic and molecular biology reagents, all of which may vary by country.
Risks Affecting our Manufacturing Operations
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 United States and other countries. Costs and
difficulties in complying with laws and regulations administered by the U.S. Food and Drug Administration, the U.S. Department of Agriculture, the U.S. Department of Commerce, the U.S. Drug Enforcement Agency, the Centers for Disease Control or
other regulators can result in unanticipated expenses and delays and interruptions to the sale of new and existing products.
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Regulatory approval can be a lengthy, expensive and uncertain process, making the timing and costs of approvals
difficult to predict. The 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.
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 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, 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 Companys or a third-party suppliers manufacturing capabilities could materially and adversely affect our operating results.
We depend on sole-source suppliers for certain critical raw materials and 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 make 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 our instrumentation. One third
party manufactures our proprietary
illumi
pro-10
Incubator/Reader (instrument), a component of our
illumi
gene
molecular system, and a separate third party manufactures our proprietary LeadCare
instruments. These instruments are manufactured exclusively for Meridian according to our specifications. While other manufacturers for these types of instruments are available, we source solely from one manufacturer to limit the costs
involved in clearing the system for marketing in the United States. 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 operating results.
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Additionally, one third party manufactures one certain reagent for use with our
illumi
gene
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.
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 12%, 15% and 14% of consolidated revenues in fiscal
2016, 2015 and 2014, 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.
Risks Related to Intellectual Property and Product Liability
We may be unable to protect or obtain proprietary rights 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.
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 diagnostic industry. 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 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 business.
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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 business.
Other Risks Affecting Our
Business
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 operating results could be adversely affected.
Our bank credit agreements impose restrictions with respect to our operations.
Our bank credit agreements contain 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 agreements, we would be in default under the credit agreements. If an event of default is not cured or waived, it could result in acceleration of any indebtedness under our credit agreements, which could have a
material adverse effect on our business. At September 30, 2016, we have approximately $59,000 outstanding on a five-year term loan entered into in connection with the Magellan acquisition and no borrowings are outstanding under our $30,000 bank
revolving credit facility.
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We face risks related to global economic conditions.
We currently generate significant operating cash flows, which combined with access to the credit markets, provides us with discretionary funding capacity for
research and development and other strategic activities. However, as an enterprise with global operations and markets, our operations and financial performance are in part dependent upon global economic conditions, and we could be negatively
impacted by a global, regional or national economic crisis, including sovereign risk in the event of deterioration in the credit worthiness of or a default by local governments. We are particularly susceptible to the economic conditions in
countries where government-sponsored health care systems are the primary payers for health care, including those countries within the European Union that are reducing their public expenditures in an effort to achieve cost savings. The
uncertainty in global economic conditions poses a risk to the overall economy that could impact demand for our products, as well as our ability to manage normal commercial relationships with our customers, suppliers and creditors, including
financial institutions. As such, if global economic conditions deteriorate significantly, our business could be negatively impacted, including such areas as reduced demand for our products from a slow-down in the general economy, supplier or
customer disruptions resulting from tighter credit markets, and/or temporary interruptions in our ability to conduct day-to-day transactions through our financial intermediaries involving the payment to or collection of funds from our customers,
vendors and suppliers. While to-date such factors have not had a significant negative impact on our results or operations, we continue to monitor and plan for the potential impact of these global economic factors.
On June 23, 2016, the United Kingdom voted to leave the European Union (commonly referred to as Brexit) and while the impact of Brexit remains
uncertain, the resulting immediate changes in foreign currency exchange rates has limited overall impact due to natural hedging. However, any predicted deterioration in the United Kingdom and European economic outlook may have an adverse effect on
revenue growth, but the extent of such effect cannot yet be quantified. In the longer term, it is highly likely we will be directly impacted in a number of key areas including the hiring and retention of qualified staff, regulatory affairs,
manufacturing and logistics. We are closely monitoring the Brexit developments in order to determine, quantify and proactively address changes as they become clear. Despite the Brexit developments, we do not expect macroeconomic conditions
to have a significant impact on our liquidity needs, financial condition or results of operations, although no assurances can be made in this regard. We intend to continue to fund our working capital requirements and dividends from current cash
flows from operating activities and cash on hand. If needed, we also have an additional source of liquidity through our $30,000 bank revolving credit facility. Our liquidity needs may change if overall economic conditions change and/or
liquidity and credit within the financial markets tightens for an extended period of time, and such conditions impact the collectibility of our customer accounts receivable or impact credit terms with our vendors, or disrupt the supply of raw
materials and services.
Breaches of our information technology systems could have a material adverse effect on our operations.
We rely on information technology systems to process, transmit and store electronic information in our day-to-day operations. Like many multinational
corporations, our information technology systems may be subjected to computer viruses or other malicious codes, unauthorized access attempts, and cyber- or phishing-attacks. We also store certain information with third parties that could be subject
to these types of attacks. Such attacks could result in our intellectual property and other confidential information being lost or stolen, disruption of our operations, and other negative consequences, such as increased costs for security measures
or remediation costs, and diversion of management attention. While we will continue to implement additional protective measures to reduce the risk of and detect cyber incidents, cyber-attacks are becoming more sophisticated and frequent, and the
techniques used in such attacks change rapidly. There can be no assurances that our protective measures will prevent attacks that could have a significant impact on our business.
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Natural disasters, war and other events could adversely affect our future revenues and operating income.
Natural disasters (including pandemics), war, terrorism, labor disruptions and international conflicts, and actions taken by the United States and
other governments or by our customers or suppliers in response to such events, could cause significant economic disruption and political and social instability in the United States and in areas outside of the United States in which we operate. These
events could result in decreased demand for our products, adversely affect our manufacturing and distribution capabilities, or increase the costs for, or cause interruptions in, the supply of materials from our suppliers.
Risks Related to Our Common Stock
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
such 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.
ITEM 1B.