MERIDIAN BIOSCIENCE INC - Annual Report: 2008 (Form 10-K)
Table of Contents
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-K
FOR ANNUAL AND TRANSITION REPORTS PURSUANT TO SECTIONS 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
OF THE SECURITIES EXCHANGE ACT OF 1934
þ | ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
FOR THE FISCAL YEAR ENDED SEPTEMBER 30, 2008.
o | 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
Incorporated under the Laws of Ohio
Phone: (513) 271-3700
Securities Registered Pursuant to Section 12(b) of the Act:
Common Shares, No Par Value
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 þ NO o
If this report is an annual or transition report, indicate by check mark if the registrant
is not required to file reports pursuant to Section 13 or 15(d) of the Securities Exchange
Act.
YES o NO þ
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, and (2) has been subject to such filing requirements for the past 90 days.
YES þ NO o
Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of
Regulation S-K (Section 229.405 of this Chapter) is not contained herein, and will
not be contained, to the best of registrants knowledge, in definitive proxy or
information statements incorporated by reference in Part III of this Form 10-K or
any amendment to this Form 10-K.
YES o NO þ
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated
filer, a non-accelerated filer, or a smaller reporting company. See the definitions of large
accelerated filer, accelerated filer and smaller reporting company in Rule 12b-2 of the
Exchange Act. (Check one):
Large accelerated filer þ | Accelerated filer o | Non-accelerated filer o (Do not check if a smaller reporting company) |
Smaller Reporting Company o |
Indicate by check mark whether the registrant is a shell company (as defined in Exchange Act Rule 12b-2).
YES o NO þ
The aggregate market value of Common Shares held by non-affiliates as of March 31, 2008
was $1,288,569,112 based on a closing sale price of $33.43 per share on March 31, 2008.
As of October 31, 2008, 40,314,930 no par value Common Shares were issued and outstanding.
Documents Incorporated by Reference
Portions of the Registrants Annual Report to Shareholders for the fiscal year ended September
30, 2008 furnished to the Commission pursuant to Rule 14a-3(b) as specified and portions of the
Registrants Proxy Statement filed with the Commission for its 2009 Annual Shareholders Meeting
are incorporated by reference in Part III as specified.
MERIDIAN BIOSCIENCE, INC.
INDEX TO ANNUAL REPORT
ON FORM 10-K
INDEX TO ANNUAL REPORT
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Item 10 Directors, Executive Officers and Corporate Governance |
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Item 13 Certain Relationships and Related Transactions, and Director Independence |
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FORWARD LOOKING STATEMENTS
The Private Securities Litigation Reform Act of 1995 provides a safe harbor from civil litigation
for forward-looking statements accompanied by meaningful cautionary statements. Except for
historical information, this Annual Report on Form 10-K contains forward-looking statements within
the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the
Securities Exchange Act of 1934, as amended, which may be identified by words such as estimates,
anticipates, projects, plans, seeks, may, will, expects, intends, believes,
should and similar expressions or the negative versions thereof and which also may be identified
by their context. Such statements, whether expressed or implied, are based upon current
expectations of the Company and speak only as of the date made. The Company assumes no obligation
to publicly update any forward-looking statements whether as a result of new information or to
reflect events or circumstances arising after the date on which they are made. These statements are
subject to various risks, uncertainties and other factors that could cause actual results to differ
materially, including, without limitation, the following: Meridians continued growth depends, in
part, on its ability to introduce into the marketplace enhancements of existing products or new
products that incorporate technological advances, meet customer requirements and respond to
products developed by Meridians competition. While Meridian has introduced a number of internally
developed products, there can be no assurance that it will be successful in the future in
introducing such products on a timely basis. Ongoing consolidations of reference laboratories and
formation of multi-hospital alliances may cause adverse changes to pricing and distribution. Costs
and difficulties in complying with laws and regulations administered by the United States Food and
Drug Administration can result in unanticipated expenses and delays and interruptions to the sale
of new and existing products. Changes in the relative strength or weakness of the US dollar can
change expected results. One of Meridians main growth strategies is the acquisition of companies
and product lines. There can be no assurance that additional acquisitions will be consummated or
that, if consummated, will be successful and the acquired businesses successfully integrated into
Meridians operations. In addition to the factors described in this paragraph, Part I, Item 1A Risk
Factors contains a list of uncertainties and risks that may affect the financial performance of the
Company.
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PART I.
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. 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 we, us,
our, or our company refer to Meridian Bioscience, Inc. and its subsidiaries.
ITEM 1.
BUSINESS
Overview
Meridian is a fully-integrated life science company whose principal businesses are (i) the
development, manufacture, sale and distribution of diagnostic test kits, primarily for certain
respiratory, gastrointestinal, viral and parasitic infectious diseases, (ii) the manufacture and
distribution of bulk antigens, antibodies, and reagents used by researchers and other diagnostic
manufacturers and (iii) the contract development and manufacture of proteins and other biologicals
for use by biopharmaceutical and biotechnology companies engaged in research for new drugs and
vaccines. By exploiting revenue opportunities across research, clinical diagnostics, and
therapeutics, we strive to maximize revenues, efficiently invest in research and development, and
increase profitability of our manufacturing operations. The company was incorporated in Ohio in
1976.
Operating Segments
Our reportable operating segments are US Diagnostics, European Diagnostics, and Life Science. The
US Diagnostics operating segment consists of manufacturing operations in Cincinnati, Ohio, and the
sale and distribution of diagnostics test kits in the US and countries outside of Europe, Africa
and the Middle East. The European Diagnostics operating segment consists of the sale and
distribution of diagnostics test kits in Europe, Africa and the Middle East. The Life Science
operating segment consists of manufacturing operations in Memphis, Tennessee, Saco, Maine, and Boca
Raton, Florida, and the sale and distribution of bulk antigens, antibodies, and bioresearch
reagents domestically and abroad. The Life Science operating segment also includes the contract
development and manufacture of proteins and other biologicals for use by biopharmaceutical and
biotechnology companies engaged in research for new drugs and vaccines. Financial
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information for Meridians operating segments is included in Note 7 to the consolidated financial
statements contained herein.
Our primary source of domestic and international revenues continues to be core diagnostic products,
which represented 83% of consolidated net sales for fiscal 2008. 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 acute 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. This approach has allowed us to
establish significant market share in our target disease states.
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. These reports
may also be read and copied at the SECs public reference room at 100 F Street, N.E., Room 1580,
Washington, DC 20549, phone 1-800-732-0330. The SEC maintains an internet site containing these
filings and other information regarding Meridian at http://www.sec.gov. The information on
our website is not part of this Annual Report on Form 10-K.
US Diagnostics Operating Segment
Overview
Our US Diagnostics operating segments business focuses on the development, manufacture, sale and
distribution of diagnostic test kits, primarily for certain respiratory, gastrointestinal, viral
and parasitic infectious diseases. In addition to diagnostic test kits, products also include
transport media that store and preserve specimen samples from patient collection to laboratory
testing. Third-party sales for this operating segment were $88,419,000, $74,845,000 and
$65,721,000 for fiscal 2008, 2007 and 2006, respectively, reflecting a three-year compound annual
growth rate of 18%. As of September 30, 2008, our US Diagnostics operating segment had 265
employees.
Our diagnostic test kits utilize immunodiagnostic technologies, which test samples of blood, urine,
stool, and other body fluids or tissue for the presence of antigens and antibodies of specific
infectious diseases. Specific immunodiagnostic technologies used in our diagnostic test kits
include enzyme immunoassay, immunofluorescence, particle agglutination/aggregation,
immunodiffusion, complement fixation, and chemical stains.
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Our diagnostic products are used principally in the detection of respiratory diseases, such as
pneumonia, valley fever, influenza, and respiratory syncytial virus (RSV); gastrointestinal
diseases, such as stomach ulcers (H. pylori), antibiotic-associated diarrhea (C. difficile) and
pediatric diarrhea (Rotavirus and Adenovirus); viral diseases, such as Mononucleosis, Herpes
Simplex, Chicken Pox and Shingles (Varicella-Zoster) and Cytomegalovirus (organ transplant
infections); and parasitic diseases, such as Giardiasis, Cryptosporidiosis and Lyme. The primary
markets and customers for these products are reference laboratories, hospitals, and physicians
offices.
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 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 treatment expense. In addition, these pressures have led to a major consolidation among
reference laboratories and the formation of multi-hospital alliances that have reduced the number
of institutional customers for diagnostic products and resulted in changes in buying practices.
Specifically, multi-year exclusive or primary source marketing or distribution contracts with
institutional customers have become more common, replacing less formal distribution arrangements of
shorter duration and involving lower product volumes.
Sales and Marketing
Our US Diagnostics operating segments sales and distribution network consists of a direct sales
force in the US and Canada and independent distributors in the US and abroad. The direct sales
force consists of three management personnel who oversee corporate health accounts and work with
managed-care institutions, and six management personnel who oversee 26 technical sales
representatives, three inside sales representatives, and independent distributors in over 25
countries. We utilize two primary independent distributors in the US, who accounted for 54% of the
US Diagnostics operating segments third-party sales in fiscal 2008. We manage the selling effort
for key customers where these independent distributors are utilized.
Consolidation of the US healthcare industry is expected to continue and potentially affect our
customers. Industry consolidation puts pressure on pricing and aggregates buying power. In
response, we have looked to
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multi-year supply agreements with consolidated healthcare providers and major reference
laboratories to stabilize pricing.
Products and Markets
We have expertise in the development and manufacture of products based on multiple core diagnostic
technologies, each of which enables the visualization and identification of antigen/antibody
reactions for specific pathogens. Our product technologies include enzyme immunoassay,
immunofluorescence, particle agglutination/aggregation, immunodiffusion, complement fixation and
chemical stains. As a result, we are able to develop and manufacture diagnostic tests in a variety
of formats that satisfy customer needs and preferences, whether in a hospital, commercial or
reference laboratory or alternate site location. Our product offering consists of approximately
145 medical diagnostic products.
Research and Development
Our US Diagnostics operating segments research and development organization consists of 14
research scientists with expertise in biochemistry, immunology, mycology, bacteriology, virology,
and parasitology. Research and development expenses for the US Diagnostics operating segment for
fiscal 2008, 2007 and 2006 were $4,878,000, $4,571,000 and $3,342,000, respectively. This research
and development organization focuses its activities on new applications for our existing
technologies, improvements to existing products and development of new technologies. 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. Our internally developed products
include Premierä Platinum HpSA PLUS, Premierä Toxins A & B, and
ImmunoCardÒ Toxins A & B, which together accounted for 38% of our US Diagnostics
operating segments third-party sales during fiscal 2008.
During fiscal 2008, we launched our first products under our recently developed and patented
TRU rapid test technology. This technology features improved safety for compliance
with CDC regulations by offering a closed system in which to perform the tests and space savings
for laboratory technicians. New products using this technology include TRU FLU®, TRU
RSV®, TRU EBV-M®, and TRU EBV-G®.
We also believe that the use of collaborative partners in the development of new products will
complement our internal research and development staff in a manner that allows us to bring products
to market more quickly than if development were to occur solely on an internal basis. During
August 2006, we entered into a partnership agreement with the Performance & Life Science Chemicals
Division of Merck KGaA, Darmstadt, Germany for the development of new clinical assays. Our first
product under this agreement, ImmunoCard STAT! ® EHEC, was launched during the second
quarter of fiscal 2007. We expect our second product in collaboration with Merck to launch during
the latter part of fiscal 2009.
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Over the last 27 months, we have begun exploring and developing a molecular-based diagnostic
testing technology to complement our existing antigen/antibody-based testing technologies. This
first look at molecular-based testing started in October 2006, when we executed a license agreement
with Eiken Chemical Co., Ltd. that provides rights to Eikens loop-mediated isothermal
amplification technology. This license provides us with rights for infectious disease testing in
the United States and 18 other geographic markets. We currently have one product in active
development using this molecular technology for C. difficile, for which we are now completing beta
site evaluations. We have successfully completed our FDA pre-submission activities and expect to
initiate clinical trials in January 2009 with a 510(k) application to follow within 90-120 days
thereafter. International revenues are likely in the second half of fiscal 2009, with US sales to
follow FDA clearance. Several other infectious diseases have been identified for future
development using this technology.
Manufacturing
Our immunodiagnostic products require the production of highly specific and sensitive antigens and
antibodies. We produce substantially all of our own requirements including monoclonal antibodies
and polyclonal antibodies, plus a variety of fungal, bacterial, and viral antigens. We believe
that we have sufficient manufacturing capacity for anticipated growth in the near term.
Intellectual Property, Patents, and Licenses
We own or license US and foreign patents for approximately 20 products manufactured by our US
Diagnostics operating segment. These patented products represented approximately 19% of
consolidated sales in fiscal 2008. 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 execute confidentiality and non-disclosure agreements designed to
protect our proprietary products.
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.
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
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all, products under development will be classified as Class I or II medical devices and, in the
case of Class II devices, will be eligible for 510(k) clearance.
Sales of our diagnostic products in foreign countries are subject to foreign government regulation,
the requirements of which vary substantially from country to country. The time required to obtain
approval by a foreign country may be longer or shorter than that required for FDA approval and the
requirements may differ.
Meridians Cincinnati manufacturing facility is certified to ISO 13485.
European Diagnostics Operating Segment
Our European Diagnostics operating segments business focuses on the sale and distribution of
diagnostic test kits, manufactured both by our US Diagnostics operating segment and by third-party
vendors. Approximately 73% of third-party sales for fiscal 2008 for this operating segment were
products purchased from our US Diagnostics operating segment. Third-party sales for this operating
segment were $27,980,000, $23,563,000 and $19,828,000 for fiscal 2008, 2007 and 2006, respectively,
reflecting a three-year compound annual growth rate of 16%. As of September 30, 2008, the European
Diagnostics operating segment had 39 employees, including 15 employees in the direct sales force.
Our European Diagnostics operating segments 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. The European Diagnostics operating segment maintains a
distribution center in Milan, Italy. The primary markets and customers for this operating segment
are hospitals and reference laboratories.
The European Diagnostics operating segments functional currency is the Euro. The translation of
Euros into US dollars is subject to exchange rate fluctuations.
Life Science Operating Segment
Overview
Our Life Science operating segments business focuses on the development, manufacture, sale, and
distribution of bulk antigens, antibodies, and reagents used by researchers and other diagnostic
companies, as well as contract development and manufacturing services under clinical cGMP
conditions. Third-party sales for this operating segment were $23,240,000, $24,555,000 and
$22,864,000 for fiscal 2008, 2007 and 2006, respectively, reflecting a three-year compound annual
growth rate of 2%. As of September 30, 2008, our Life Science operating segment had 107 employees.
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Most of the revenue for our Life Science operating segment currently comes from the manufacture,
sale and distribution of bulk antigens, antibodies, and reagents used by researchers and other
diagnostic companies. During fiscal 2008, 21% of third-party sales for this segment were to one
customer, a substantial portion of which is under exclusive supply agreements that have annual,
automatic renewal provisions. We have a long-standing relationship with this customer; and
although there can be no assurances, we intend to renew these supply agreements in the normal
course of business. During fiscal 2008, sales to three other customers comprised 17% of
third-party sales for the Life Science operating segment.
Our clinical cGMP protein production facility in Memphis, Tennessee serves as an enabling
technology for process development and large-scale manufacturing for biologicals used in new drugs
and vaccines. The size of the facility is intended to accommodate manufacturing requirements for
Phase I and Phase II clinical trials. The customer base for this aspect of our Life Science
business includes biopharmaceutical and biotechnology companies, as well as government agencies,
such as the National Institutes of Health. Revenues for our Life Science operating segment, in the
normal course of business, may be affected from quarter to quarter by the timing and nature of
arrangements for contract services work, which may have longer production cycles than bioresearch
reagents and bulk antigens and antibodies, as well as buying patterns of major customers. See Note
1(i) to the Consolidated Financial Statements herein for revenue recognition policies. Our
revenues for contract services were $1,477,000, $765,000, and $2,537,000 in fiscal 2008, 2007, and
2006, respectively.
During fiscal 2008, we acquired certain technologies and products from Vybion, Inc., including
infectious disease recombinant proteins and cardiac antigens. This acquisition adds important
technologies and capabilities to our Life Science business and will add to our expanding life
science brands. The acquired technologies will add proprietary manufacturing know-how and access to
important patent licenses for the development and production of recombinant proteins, an emerging
technology in life sciences.
Products, Markets and Growth Strategies
Our Life Science operating segments businesses have been assembled via acquisitions (BIODESIGN
International in fiscal 1999, Viral Antigens in fiscal 2000, and, most recently, OEM Concepts in
fiscal 2005). Historically, these businesses were run autonomously. Recently, growth strategies
have been developed around sales and marketing integration, new product development integration,
and four product brands. Our Life Science operating segments four product brands can be described
as follows:
| BIODESIGN Antibodies, antigens and assay development reagents | ||
| Viral Antigens Custom infectious disease antigens | ||
| OEM Concepts Custom antibody development and manufacturing, in vivo or in vitro | ||
| Meridian Biologics Development and manufacturing of cGMP clinical grade biologicals |
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We believe that the business and growth prospects for all four product brands are favorable.
Products from the BIODESIGN, OEM Concepts, and Viral Antigens brands are marketed primarily to
diagnostic manufacturing customers as a source of raw materials for their products, or as an
outsourced step in their manufacturing processes. These markets are highly fragmented; however, we
believe we can be successful through product and marketing integration and customer penetration
across these three brands. These three brand names were aligned with the predecessor company
names, prior to acquisition, as we believe that there is value in the names of these long-standing
businesses. Sales efforts are focused on multi-year supply agreements in order to provide
stability in volumes and pricing. We believe this benefits both us and our customers.
With respect to our Meridian Biologics brand and contract services, we believe that the business
prospects are also favorable despite our recent revenue trends for this brand. In August 2007, we
were awarded a five-year contract (base year plus four option years) for the manufacturing of
experimental clinical vaccines for the National Institutes of Allergy and Infectious Diseases of
the National Institutes of Health. This contract provides an opportunity for steady production
work over a five-year period. We recognized revenue related to this contract of $265,000 in fiscal
2008 and expect to have revenues related to this contract of approximately $500,000 to $700,000 in
fiscal 2009. We also currently have three other vaccine projects in progress or within our
business development pipeline that are expected to contribute approximately $2,100,000 in revenues
for fiscal 2009.
Research and Development
Our Life Science operating segments research and development organization consists of four
research scientists. Research and development expenses for our Life Science operating segment for
fiscal 2008, 2007 and 2006 were $1,305,000, $1,514,000 and $1,457,000, respectively. This research
and development organization has integrated its activities around the four product brands
previously discussed and also is heavily involved in vaccine development and production activities
for our cGMP facility.
Manufacturing and Government Regulation
The cGMP clinical grade proteins that are produced in our Memphis facility are intended to be used
as injectibles, and, as such, they are produced under cGMP Regulations for Biologics and Human
Drugs under the auspices of the FDA. Approval and licensing, following clinical trials, of these
products is the responsibility of the applicant, who owns the rights to each protein. Typically,
the customer is the applicant, not Meridian Life Science.
All of the Meridian Life Science facilities are ISO 9001:2000 certified and EC 1774:2002 approved.
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Competition
Diagnostics
The market for diagnostic tests is a multi-billion dollar international industry, which is highly
competitive. Many of our competitors are larger with greater financial, research, manufacturing
and marketing resources. Important competitive factors for Meridians products include product
quality, price, ease of use, customer service, and reputation. In a broader sense, industry
competition is based upon scientific and technological capability, proprietary know-how, access to
adequate capital, the ability to develop and market products and processes, the ability to attract
and retain qualified personnel and the availability of patent protection. To the extent that our
product lines do not reflect technological advances, our ability to compete in those product lines
could be adversely affected.
The diagnostic test industry is highly fragmented and segmented. Of importance in the industry are
mid-sized medical diagnostic specialty companies, like Meridian, that offer multiple, broad product
lines and have the ability to deliver new, high value products quickly to the marketplace. Among
the companies with which we compete in the marketing of one or more of our products are the
diagnostic product divisions of Abbott Laboratories Inc., Becton, Dickinson and Company, Thermo
Fisher and Siemens. We also compete with smaller companies such as Quidel Corporation and
Inverness Medical Innovations.
Life Science
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. From time to time, customers
may choose to manufacture their biomedical reagents in-house rather than purchase from outside
vendors such as Meridian.
The market for contract manufacturing in a validated cGMP facility, such as our Memphis facility,
is also competitive. Important competitive factors include reputation, customer service, and
price. Although the product application for this facility was built from our existing expertise in
cell culture manufacturing techniques, we face competitors with greater experience in contract
manufacturing in a clinical cGMP environment.
Acquisitions
Acquisitions have played an important role in the historical growth of our businesses. Our
acquisition objectives include, among other things, (i) enhancing product offerings, (ii) improving
product distribution
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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 any
assurance that we will consummate any acquisitions in the future, we expect that the potential for
acquisitions will continue to serve as an opportunity for new revenues and earnings growth in the
future.
International Markets
International markets are an important source of revenue and future growth opportunities for all of
our operating segments. For all operating segments combined, international sales were $44,430,000
or 32% of total fiscal 2008 sales, $38,691,000 or 31% of total fiscal 2007 sales and $34,557,000 or
32% of total fiscal 2006 sales. Domestic exports for our US Diagnostics and Life Science operating
segments were $16,450,000, $15,128,000 and $14,729,000 in fiscal 2008, 2007 and 2006, respectively.
We expect to continue to look to international markets as a source of new revenues and growth in
the future.
Environmental
We are a conditionally exempt, small quantity generator of hazardous waste and have a US EPA
identification number. 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
respond to products developed by our competition.
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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
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.
During 2008, 2007, and 2006, we incurred $6,183,000, $6,085,000, and $4,799,000, respectively, in
research and development expenses. We expect to continue to invest in our research and development
activities.
We may be unable to successfully integrate operations or to achieve expected cost savings from
acquisitions we make.
One of our main 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 any
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 diagnostic operating segments may be impacted by our reliance upon two key
distributors, seasonal factors and sporadic outbreaks, and changing diagnostic market conditions.
Key Distributors
Our US Diagnostic operating segments sales through two distributors were 54% and 50%,
respectively, of the US Diagnostics operating segments total sales for fiscal 2008 and fiscal
2007, or 34% and 31%, respectively, of consolidated total sales for fiscal 2008 and fiscal 2007.
These parties distribute our products and other laboratory products to end-user customers. The loss
of either of these distributors could negatively impact our sales 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.
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In addition, buying patterns of these two distributors may fluctuate from quarter to quarter,
potentially leading to uneven concentration levels on a quarterly basis. However, we expect that,
over a 12-month period, these distributors orders would follow a normal buying pattern.
Seasonal Factors and Sporadic Outbreaks
Our principal business is the sale of a broad range of diagnostic test kits for common upper
respiratory, gastrointestinal, viral, and parasitic infectious diseases. Certain infectious
diseases may be seasonal in nature, while others may be associated with sporadic outbreaks, such as
foodborne illnesses. While we believe that the breadth of our diagnostic product lines reduces
the risk that infections subject to seasonality and sporadic outbreaks will cause 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 healthcare delivery system have resulted in major consolidation among reference
laboratories and in the formation of multi-hospital alliances, reducing the number of institutional
customers for diagnostic test products. 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, which could adversely affect our results of
operations.
Third-party payers for medical products and services, including state and federal 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. 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 sales and/or profit margins.
Revenues for our Life Science operating segment may be impacted by customer concentrations and
buying patterns.
Our Life Science operating segments sales of purified antigens and reagents to one customer were
21% and 27%, respectively, of the Life Science operating segments total sales for fiscal 2008 and
fiscal 2007, or 3% and 5%, respectively, of our consolidated total sales for fiscal 2008 and fiscal
2007. A substantial portion of these sales are under exclusive supply agreements that have annual,
automatic renewal provisions. Although we have a long-standing relationship with this customer, we
cannot provide any assurance that we will be able to renew these supply agreements, which could
adversely affect our sales and results of operations.
Our Life Science operating segment has three other significant customers who purchase antigens,
antibodies and reagents, which together comprised 17% and 20%, respectively, of the operating
segments total sales for
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fiscal 2008 and 2007. Any significant alteration of buying patterns from these customers could
adversely affect our period over period sales and results of operations.
Revenues relating to research, development and manufacturing services for our Life Science
operating segment are generated on a contract by contract basis. The nature of this business is
such that each contract provides a unique product and/or service and corresponding revenue stream.
Although we believe that future prospects for this business will generate targeted growth rates,
there can be no assurance that future contracts will be secured, and if secured, will be
profitable.
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 in the United States supply immunodiagnostic tests and purified
reagents. These companies range from multinational healthcare entities, for which
immunodiagnostics 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 any assurance that our products and services will be able to compete
successfully with the products and services of our competitors.
We are dependent on international sales, 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 60 countries. Approximately 32% of our net sales
for fiscal 2008 and approximately 31% of our net sales for fiscal 2007 were attributable to
international markets. For fiscal 2008, 54% of our international sales were made in Euros, with the
remaining 46% made in US dollars. We are subject to the risks associated with fluctuations in the
US dollar-Euro exchange rates. We are also subject to other risks associated with international
operations, including longer customer payment cycles, tariff regulations, requirements for export
licenses, stability of foreign governments, and governmental requirements with respect to the
importation and distribution of medical devices and antigens, antibodies and 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 and the manufacture, sale, and distribution of bulk antigens,
antibodies, and reagents are highly regulated industries. We cannot provide any 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 US Food and Drug
Administration, the US Department of Agriculture, the US Department of Commerce, the US Drug
Enforcement Agency, or the Centers for Disease Control can result in
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unanticipated expenses and delays and interruptions to the sale of new and existing products.
Contract manufacturing of proteins and other biologicals is regulated by the US Food and Drug
Administration.
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
delay 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 our Cincinnati, Ohio, Boca Raton, Florida, Memphis,
Tennessee, and Saco, Maine facilities comprised 77% of our diagnostics revenues and 71% of our Life
Science 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. 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 third-party manufacturing capabilities could materially and
adversely affect our operating results.
We are dependent on sole-source suppliers for certain critical components and products. A supply
interruption could adversely affect our business.
Our products are made from a wide variety of raw materials that are generally available from
alternate sources of supply. However, certain critical raw materials and supplies required for the
production of some of our principal products are available only from a single supplier. In
addition, certain finished products, for which we act as a distributor, are available only from a
single supplier. If these suppliers become unable or unwilling to supply the required raw
materials or products, we would need to find another source, and perform additional development
work and obtain regulatory approvals for the use of the alternative raw materials for our products.
Completing that development and obtaining such approvals could require significant time and
resources, and may not occur at all. Any disruption in the supply of these raw materials or
finished products could have a material adverse affect on us.
Four respiratory products sourced from one vendor accounted for 14% and 11% of third-party sales
for our US Diagnostics operating segment in fiscal 2008 and 2007, respectively. During fiscal
2008, we launched our own internally-developed products that compete with these products in the
market. In order to mitigate the supply risk associated with these products, we have signed a
minimum purchase agreement with the vendor to fulfill our projected needs through June 30, 2009.
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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 any 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 any assurances that we will be successful in obtaining 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. We currently carry intellectual property insurance that covers
damages and defense costs from our potential infringement on other third-party patents at levels
that we believe are commercially reasonable, although there is no assurance that it will be
adequate to cover claims that may arise. Any substantial underinsured loss resulting from such a
claim could have a material adverse affect on our profitability and the damage to our reputation in
the industry could have a material adverse affect on our business.
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 affect on our reputation in the
industry and subject us to claims of liability for injury and otherwise. Any substantial
underinsured loss resulting from
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such a claim could have a material adverse affect on our profitability and the damage to our
reputation in the industry could have a material adverse affect 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 agreement imposes restrictions with respect to our operations.
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 the present time, no borrowings are outstanding under
our bank credit agreement.
In recent months, the credit markets and the banking industry have been experiencing a period of
unprecedented turmoil and upheaval characterized by the bankruptcy, failure, collapse, or sale of
various financial institutions. In response, the United States federal government has put into
place a number of economic measures designed to stabilize the markets. While the ultimate outcome
of these events cannot be predicted, they may have a material adverse effect on our results of
operations should our ability to borrow money to finance our operations from our existing lenders
under our bank credit agreement or obtain credit from trade creditors be impaired. As our credit
agreement is in place through September 2012, we believe that the current economic conditions in
the credit markets will not have an adverse effect on our business.
Risks Related to Our Common Stock
Our board of directors has the authority to issue up to 1,000,000 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.
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ITEM 1B.
UNRESOLVED STAFF COMMENTS
Not applicable.
ITEM 2.
PROPERTIES
Our corporate offices, US Diagnostics manufacturing facility and US Diagnostics research and
development facility are located in three buildings totaling approximately 94,000 square feet on
6.2 acres of land in a suburb of Cincinnati, Ohio. These properties are owned by us. We have
approximately 51,000 square feet of manufacturing space and 9,000 square feet of warehouse space in
these facilities.
Our European Diagnostics distribution center in Italy conducts its operations in a two-story
building in Milan, consisting of approximately 18,000 square feet. This facility is owned by our
wholly-owned Italian subsidiary, Meridian Bioscience Europe s.r.l. We also rent office space in
France and Belgium for sales and administrative functions.
Our Life Science operations are conducted in several facilities in Saco, Maine, Memphis, Tennessee,
and Boca Raton, Florida. Our facility in Saco, Maine presently contains approximately 23,000
square feet for manufacturing, sales, distribution and administrative functions, and is owned by
us. Our facility in Memphis, Tennessee consists of two buildings totaling approximately 34,000
square feet, including approximately 27,000 square feet of manufacturing space, and is owned by us.
Our leased facility in Boca Raton, Florida contains approximately 11,000 square feet of
manufacturing space.
ITEM 3.
LEGAL PROCEEDINGS
We are a party to litigation that we believe is in the normal course of business. The ultimate
resolution of these matters is not expected to have a material adverse effect on our financial
position, results of operations or cash flows. No provision has been made in the accompanying
consolidated financial statements for these matters.
ITEM 4.
SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
Not applicable.
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PART II.
ITEM 5.
MARKET FOR REGISTRANTS COMMON
EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY
SECURITIES
EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY
SECURITIES
Please refer to Forward Looking Statements following the Index in front of the Form 10-K.
Common Stock Information on the inside back cover of the Annual Report to Shareholders for 2008
and Quarterly Financial Data relating to our dividends in Note 9 to the Consolidated Financial
Statements are incorporated herein by reference. There are no restrictions on cash dividend
payments.
Our cash dividend policy is to set the indicated annual dividend rate between 75% and 85% of each
fiscal years expected net earnings. The 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 and future business developments and opportunities, including acquisitions.
We paid dividends of $0.53 per share, $0.40 per share, and $0.28 per share in fiscal 2008, fiscal
2007, and fiscal 2006, respectively.
On May 11, 2007, we affected a three-for-two stock split for shareholders of record on May 4, 2007.
All references in this Annual Report to number of shares and per share amounts reflect the effects
of this stock split.
As of September 30, 2008, there were approximately 900 holders of record and approximately 26,000
beneficial owners of its common shares.
ITEM 6.
SELECTED FINANCIAL DATA
Incorporated by reference from inside front cover of the Annual Report to Shareholders for 2008.
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ITEM 7.
MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL
CONDITION AND RESULTS OF OPERATIONS
CONDITION AND RESULTS OF OPERATIONS
Refer to Forward Looking Statements following the Index in front of this Form 10-K and Item 1A
Risk Factors on pages 13 through 19 of this Annual Report.
Overview:
Despite the turmoil of the US economy and financial markets, we delivered our sixth consecutive
year of double-digit revenue and earnings growth in fiscal 2008, driven by new product launches and
market and market share expansions in certain product families in our diagnostics operating
segments. Our diagnostics operating segments continue to provide the largest share of consolidated
revenues, 83%, 80%, and 79% for fiscal 2008, 2007, and 2006, respectively. During fiscal 2008, we
launched four new diagnostic tests on our recently developed and patented TRU rapid
test technology. Revenues for our four major infectious disease categories, C. difficile, H.
pylori, upper respiratory and foodborne, all grew at double-digit rates during fiscal 2008.
As we look forward, we continue to see growth opportunities in the C. difficile and H. pylori
testing markets where such markets are well established and we hold market leadership positions.
The C. difficile market has experienced more virulent strains of this toxin and heightened focus by
hospitals on this dangerous pathogen. New AGA guidelines are creating increased focus on direct
antigen testing for H. pylori, as this infection is a known cause of ulcers. Our managed care
efforts are also expected to continue to contribute to volume growth in H. pylori products. Our
line of patented H. pylori products includes two direct testing formats. We also expect to see
growth in molecular technologies, with new product launches planned for fiscal 2009, including our
new molecular ILLUMIgeneTM C. difficile test. We have successfully completed our FDA
pre-submission activities and expect to initiate clinical trials in January with a 510(k)
application to follow within 90-120 days thereafter. International revenues are likely in the
second half of fiscal 2009, with US sales to follow FDA clearance.
We also see growth opportunities in our other two major infectious disease markets, upper
respiratory and foodborne. In the foodborne market, we intend to develop and launch other
infectious disease products that will complement our existing E. coli products. In the upper
respiratory market, we expect to see market share gains from the penetration of our recently
developed and launched influenza and respiratory syncytial virus products using our patented
TRU rapid test technology, as well as improvements in gross margins related to our
internally-developed tests.
Revenues for our Life Science operating segment were disappointing in fiscal 2008 as they were 5%
lower than fiscal 2007. This reduction was primarily due to demand and buying patterns of certain
of our bulk viral protein and reagent customers. At this time, we believe such demand and buying
patterns have reached a point where we do not expect any further year-over-year revenue reductions.
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Financial discipline continues to be one of our fundamental principles in running the day-to-day
business. The following table illustrates key income and expense elements as a percentage of
sales. We look for continued improvement in each of these measures each year, in spite of
macro-economic market conditions.
2008 | 2007 | 2006 | ||||||||||
Gross profit |
62 | % | 61 | % | 60 | % | ||||||
Operating expenses |
30 | % | 32 | % | 35 | % | ||||||
Operating income |
32 | % | 28 | % | 25 | % |
Preservation of the capital of our investment portfolio is also a fundamental principle in our cash
management philosophy. During October 2008, we moved substantially all of our investments in
municipal variable rate demand notes to institutional money market mutual funds invested in either
US Treasuries, or repurchase agreements collateralized by US Treasuries. Existing investments in
institutional tax-exempt money market mutual funds are covered under the US Treasurys Temporary
Guarantee Program for Money Market Funds. This program provides a guarantee to money market mutual
fund shareholders of $1 per share net asset value for funds invested as of September 19, 2008, if
the fund were to liquidate its assets as a result of its net asset value falling below $0.995. As
we look forward, we will continue to manage the holdings of our investment portfolio with
preservation of capital being the primary objective.
Operating Segments:
Our reportable operating segments are US Diagnostics, European Diagnostics, and Life Science. The
US Diagnostics operating segment consists of manufacturing operations in Cincinnati, Ohio, and the
sale and distribution of diagnostic test kits in the US and countries outside of Europe, Africa and
the Middle East. The European Diagnostics operating segment consists of the sale and distribution
of diagnostic test kits in Europe, Africa and the Middle East. The Life Science operating segment
consists of manufacturing operations in Memphis, Tennessee, Saco, Maine, and Boca Raton, Florida,
and the sale and distribution of bulk antigens, antibodies, and bioresearch reagents domestically
and abroad. The Life Science operating segment also includes the contract development and
manufacture of proteins and other biologicals for use by biopharmaceutical and biotechnology
companies engaged in research for new drugs and vaccines.
Revenues for the Diagnostics operating segments, in the normal course of business, may be affected
by buying patterns of major distributors, seasonality and strength of certain diseases and foreign
currency exchange rates. Revenues for the Life Science operating segment, in the normal course of
business, may be affected by the timing and nature of arrangements for contract services work,
which may have longer production cycles than bioresearch reagents and bulk antigens and antibodies,
as well as buying patterns of major customers. We believe that the overall breadth of our product
lines serves to reduce the variability in consolidated revenues.
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Results of Operations:
Fourth Quarter
Net earnings for the fourth quarter of fiscal 2008 increased 19% to $7,684,000, or $0.19 per
diluted share (increased 19%) from net earnings for the fourth quarter of fiscal 2007 of
$6,444,000, or $0.16 per diluted share. This increase is primarily attributable to increased sales
and continuing efforts to improve operating efficiency across all businesses. Net sales for the
fourth quarter of fiscal 2008 were $36,475,000, an increase of $4,089,000 or 13% compared to the
fourth quarter of fiscal 2007.
Net sales for the US Diagnostics operating segment for the fourth quarter of fiscal 2008 increased
24% compared to the fourth quarter of fiscal 2007, and benefited from volume increases in influenza
and respiratory syncitial virus products in advance of the 2008-2009 upper respiratory season in
the amount of approximately $1,500,000. The early start to the season was driven by the timing of
promotions offered by a third-party manufacturer of certain products, which are passed along to our
customers. We expect that the US Diagnostics operating segments sales of these products during
the first quarter of fiscal 2009 will be flat compared to the first quarter of fiscal 2008 as a
result of the timing of this third-party manufacturer promotion. We ultimately measure our growth
and level of success for upper respiratory products based on the full selling season, which
typically runs from August through March, also taking into consideration the relative strength of
the season. Net sales for our European Diagnostics and Life Science operating segments increased
9% and decreased 13%, respectively, during the fourth quarter of fiscal 2008 compared to the fourth
quarter of fiscal 2007.
Fiscal Year
Net earnings for fiscal 2008 increased 13% to $30,202,000, or $0.74 per diluted share (increased
12%) from net earnings for fiscal 2007 of $26,721,000, or $0.66 per diluted share including the tax
benefit of $2,425,000, described below. Results of operations for fiscal 2008 compared to fiscal
2007 are discussed below.
Net earnings and earnings per share for fiscal 2007 include the effects of a tax benefit in the
amount of $2,425,000, or $0.06 per basic and diluted share, related to a discrete adjustment to tax
reserves that was recorded in the third quarter upon the expiration of the statute of limitations
on certain income tax returns (see Note 5 to the consolidated financial statements herein). The
tables below provide information on net earnings, basic earnings per share, and diluted earnings
per share, excluding this tax benefit, as well as reconciliations to amounts reported under US
Generally Accepted Accounting Principles. We believe that this information is useful to those who
read our financial statements and evaluate our operating results because:
1. These measures help to appropriately evaluate and compare the results of operations from period
to period by removing the favorable impact of a discrete material item that is not expected to
recur in the future; and
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2. These measures are used by our management for various purposes, including evaluating performance
against incentive bonus achievement targets, comparing performance from period to period in
presentations to our Board of Directors, and as a basis for strategic planning and forecasting.
2008 | 2007 | Change | ||||||||||
Net Earnings - |
||||||||||||
US GAAP basis |
$ | 30,202,000 | $ | 26,721,000 | 13 | % | ||||||
Tax benefit not expected to recur in the future |
| (2,425,000 | ) | 100 | % | |||||||
Excluding tax benefit |
$ | 30,202,000 | $ | 24,296,000 | 24 | % | ||||||
2008 | 2007 | Change | ||||||||||
Net Earnings per Basic Common Share - |
||||||||||||
US GAAP basis |
$ | 0.75 | $ | 0.67 | 12 | % | ||||||
Tax benefit not expected to recur in the future |
| (0.06 | ) | 100 | % | |||||||
Excluding tax benefit |
$ | 0.75 | $ | 0.61 | 23 | % | ||||||
2008 | 2007 | Change | ||||||||||
Net Earnings per Diluted Common Share - |
||||||||||||
US GAAP basis |
$ | 0.74 | $ | 0.66 | 12 | % | ||||||
Tax benefit not expected to recur in the future |
| (0.06 | ) | 100 | % | |||||||
Excluding tax benefit |
$ | 0.74 | $ | 0.60 | 23 | % | ||||||
Prior to July 1, 2007, the cost of certain inventories within the Life Science operating segment
was determined by the last-in, first-out (LIFO) method. Effective July 1, 2007, we changed our
method of accounting for this inventory from the LIFO method to the FIFO method, and now
substantially all of our inventories are reflected at the lower of cost or market with cost
determined by the FIFO method. We changed to the FIFO method for these inventories because it
conforms substantially all of our worldwide inventories to a consistent basis of accounting; and it
provides better comparability to our industry peers, many of whom use the FIFO method of accounting
for inventories. In accordance with Statement of Financial Accounting Standards (SFAS) No. 154,
Accounting Changes and Error Corrections, the change in accounting has been retrospectively applied
to all prior periods presented herein.
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Fiscal Year Ended September 30, 2008 Compared to Fiscal Year Ended September 30, 2007 and Fiscal
Year Ended September 30, 2007 Compared to Fiscal Year Ended September 30, 2006.
Net sales
2008 vs. | 2007 vs. | |||||||||||||||||||
2007 | 2006 | |||||||||||||||||||
2008 | 2007 | 2006 | Inc (Dec) | Inc (Dec) | ||||||||||||||||
US Diagnostics |
$ | 88,419,000 | $ | 74,845,000 | $ | 65,721,000 | 18 | % | 14 | % | ||||||||||
European Diagnostics |
27,980,000 | 23,563,000 | 19,828,000 | 19 | % | 19 | % | |||||||||||||
Life Science |
23,240,000 | 24,555,000 | 22,864,000 | (5 | )% | 7 | % | |||||||||||||
Consolidated |
$ | 139,639,000 | $ | 122,963,000 | $ | 108,413,000 | 14 | % | 13 | % | ||||||||||
International - |
||||||||||||||||||||
Exported from US |
$ | 16,450,000 | $ | 15,128,000 | $ | 14,729,000 | 9 | % | 3 | % | ||||||||||
European Diagnostics |
27,980,000 | 23,563,000 | 19,828,000 | 19 | % | 19 | % | |||||||||||||
Total |
$ | 44,430,000 | $ | 38,691,000 | $ | 34,557,000 | 15 | % | 12 | % | ||||||||||
% of total sales |
32 | % | 31 | % | 32 | % |
Sales growth for US Diagnostics was primarily driven by volume increases across our four major
infectious disease categories, C. difficile, H. pylori, upper respiratory and foodborne in both
fiscal 2008 and 2007. Each of these product families experienced double-digit growth rates in
fiscal 2008 and 2007. New product sales contributions in fiscal 2008 came from our upper
respiratory TRU products for influenza and respiratory syncytial virus launched in the first
quarter of fiscal 2008, and our ImmunoCard STAT!® EHEC product launched in fiscal 2007.
The EHEC product was developed in collaboration with Merck for detection of toxin-producing E. coli
in patients that may have ingested contaminated produce or meat products. We also saw market share
expansions in fiscal 2008 and 2007 in infectious diseases where we have established leadership
positions, C. difficile and H. pylori. The identification of more virulent strains of C. difficile
has led to increased testing in hospitals. New AGA guidelines have created increased focus on
direct antigen testing for H. pylori, as this infection is a known cause of ulcers. Our managed
care efforts are also contributing to volume growth in H. pylori products. Two national
distributors accounted for 54%, 50% and 46% of total third-party sales for the US Diagnostics
operating segment for fiscal 2008, 2007, and 2006, respectively.
The 2007-2008 upper respiratory season was relatively strong, which also contributed to the volume
growth in influenza and respiratory syncytial virus products during the first half of fiscal 2008.
Although we cannot predict the strength of the 2008-2009 upper respiratory season and its impact on
sales volumes, to date, we have experienced healthy orders for our upper respiratory products.
Sales growth for the European Diagnostics operating segment includes currency translation gains in
the amounts of $2,743,000 and $1,510,000, for fiscal 2008 and 2007, respectively. Organic sales
growth, which excludes the effects of currency translation, was 7% and 11% during fiscal 2008 and
2007, respectively. The organic growth in fiscal 2008 and 2007 was driven by volume increases in
C. difficile products, principally
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ImmunoCardÒ Toxins A & B, as well as the third quarter fiscal 2008 launch of
TRU EBV-M® and TRU EBV-G®.
Fiscal 2008 sales for the Life Science operating segment reflect changes in demand and buying
patterns of certain of our major diagnostic manufacturing customers and non-renewal of a supply
contract with the US Department of Defense. Changes in the US Department of Defenses Critical
Reagents program led to non-renewal of this contract after fiscal 2007. Fiscal 2007 sales for the
Life Science operating segment reflect volume growth in make-to-order bulk antigens and antibodies,
offset by lower sales activity from contract research and development and contract manufacturing
services.
We sell three main products to a major diagnostic manufacturing customer, who accounted for 21%,
27%, and 18% of total sales for the Life Science operating segment for fiscal 2008, 2007 and 2006,
respectively. During the first quarter of fiscal 2008, this customer reduced its forecasted
requirements for two antigen products due to its internal inventory management initiatives and its
market factors. The impact of this reduction was partially offset by the customers increased
purchases of a bulk reagent product. For fiscal 2008, these demand changes and buying patterns
resulted in a net revenue reduction of approximately $1,800,000.
Gross Profit
2008 vs. | 2007 vs. | |||||||||||||||||||
2007 | 2006 | |||||||||||||||||||
2008 | 2007 | 2006 | Inc (Dec) | Inc (Dec) | ||||||||||||||||
Gross Profit |
$ | 86,480,000 | $ | 74,940,000 | $ | 64,684,000 | 15 | % | 16 | % | ||||||||||
Gross Profit Margin |
62 | % | 61 | % | 60 | % | 1 | % | 1 | % |
The increases in gross profit margins from 2006 to 2008 reflect a stronger mix of sales from our
diagnostic operating segments, including higher margins on rapid tests, and production efficiencies
from automation initiatives in our diagnostics manufacturing facility.
Our overall operations consist of the sale of diagnostic test kits for various disease states and
in alternative test formats, as well as bioresearch reagents, bulk antigens and antibodies,
proficiency panels, and contract research and development and contract manufacturing services.
Product sales mix shifts, in the normal course of business, can cause the consolidated gross
profit margin to fluctuate by several points.
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Operating Expenses
Research & | Selling & | General & | ||||||||||
Development | Marketing | Administrative | ||||||||||
2006 Expenses |
$ | 4,799,000 | $ | 16,698,000 | $ | 16,293,000 | ||||||
% of Sales |
4 | % | 15 | % | 15 | % | ||||||
Fiscal 2007 Increases (Decreases): |
||||||||||||
US Diagnostics |
1,229,000 | (9,000 | ) | 1,606,000 | ||||||||
European Diagnostics |
| 469,000 | (392,000 | ) | ||||||||
Life Science |
57,000 | (34,000 | ) | (806,000 | ) | |||||||
2007 Expenses |
$ | 6,085,000 | $ | 17,124,000 | $ | 16,701,000 | ||||||
% of Sales |
5 | % | 14 | % | 14 | % | ||||||
% Increase (Decrease) |
27 | % | 3 | % | 3 | % | ||||||
Fiscal 2008 Increases (Decreases): |
||||||||||||
US Diagnostics |
307,000 | 1,523,000 | (293,000 | ) | ||||||||
European Diagnostics |
| 423,000 | 389,000 | |||||||||
Life Science |
(209,000 | ) | (300,000 | ) | 380,000 | |||||||
2008 Expenses |
$ | 6,183,000 | $ | 18,770,000 | $ | 17,177,000 | ||||||
% of Sales |
4 | % | 13 | % | 12 | % | ||||||
% Increase (Decrease) |
2 | % | 10 | % | 3 | % |
Operating expenses increased 6% for both fiscal 2008 and fiscal 2007. The overall increase in
operating expenses for both periods is discussed below.
The increase in research and development expenses for the US Diagnostics operating segment during
fiscal 2008 reflects additional salaries and benefits related to a new vice president hired in May
2007, planned staff headcount additions, and development costs for our ILLUMIgeneTM
molecular technology and other products in development. These increases were partially offset by
decreased professional fees and clinical trial costs related to new products which were launched
during the first fiscal quarter of 2008. The increase in research and development expenses for
the US Diagnostics operating segment during fiscal 2007 were primarily attributable to clinical
trial and other costs associated with new product development, including planned headcount
additions, as well as increased stock-based compensation expense. The decrease in research and
development expenses for the Life Science operating segment during fiscal 2008 primarily related
to retirements of staff personnel that occurred during fiscal 2007 and lower incentive
compensation.
Selling and marketing expenses for the US Diagnostics operating segment for fiscal 2008 increased
primarily due to costs for new product launches, increased salaries and benefits related to planned
headcount additions, and higher incentive compensation from sales growth. The decrease for the US
Diagnostics operating segment for fiscal 2007 was primarily attributable to lower costs for sales
promotions, advertising, and distributor incentives, offset by increased salaries and benefits
related to headcount additions and stock-based
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compensation costs. Selling and marketing expenses for the European Diagnostics operating segment
increased primarily as a result of fluctuations in the Euro currency for both fiscal 2008 and 2007,
and one planned headcount addition in fiscal 2007. The decrease in selling and marketing expenses
for the Life Science operating segment for fiscal 2008 primarily related to lower incentive
compensation and staff reductions.
The decrease in general and administrative expenses for fiscal 2008 for the US Diagnostics
operating segment was primarily attributable to reduced incentive compensation costs, both
corporate incentive bonus and stock-based compensation. These decreases were partially offset by
increased salaries and benefits related to planned headcount additions. The increase in general
and administrative expenses for the US Diagnostics operating segment for fiscal 2007 was primarily
attributable to higher costs for stock-based compensation, an insurance recovery in fiscal 2006,
and increased salaries and benefits, including the effects of planned headcount additions. The
increase for the Life Science operating segment for fiscal 2008 reflects severance costs for
certain personnel changes and increased salaries and benefits. The decrease for the Life Science
operating segment for fiscal 2007 was primarily attributable to the 2006 impairment of the supply
contract with the United States Department of Defense. See Note 1(h) to the consolidated
financial statements contained herein. The increase for the European Diagnostics operating
segment for fiscal 2008 was primarily attributable to currency fluctuations, as well as increased
salaries and benefits. The decrease for the European Diagnostics operating segment for fiscal
2007 was primarily attributable to expenses connected with an employee matter in fiscal 2006,
which were covered by the aforementioned insurance recovery.
We account for our stock option plans pursuant to SFAS No. 123(R), Share-Based Payment. The amount
of stock-based compensation expense reported for fiscal 2008, fiscal 2007, and fiscal 2006 was
$1,772,000, $2,632,000, and $1,082,000, respectively. During November 2007, we granted to certain
employees stock options that were contingent upon Meridian achieving a specified net earnings level
for fiscal 2008. Because Meridians fiscal 2008 net earnings did not reach the minimum level,
these stock options were not earned. No stock-based compensation has been recorded for these
options. Similarly, during November 2006, we granted to certain employees stock options that were
contingent upon Meridian achieving a specified net earnings level for fiscal 2007. Because
Meridians fiscal 2007 net earnings surpassed the minimum level, these stock options were earned
and are now exercisable over a vesting period.
Operating Income
Operating income increased 27% and 30% in fiscal 2008 and 2007, respectively, as a result of the
factors discussed above.
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Other Income and Expense
Interest income was $1,533,000, $1,642,000, and $1,123,000 for fiscal 2008, 2007, and 2006,
respectively. The decrease during fiscal 2008 was driven by lower interest yields in the current
interest rate environment, somewhat offset by higher average investment balances. The increase
during fiscal 2007 was driven by higher interest yields and higher investment balances in fiscal
2007. See Note 1(e) to the consolidated financial statements herein for discussion of our
investment portfolio.
Income Taxes
The effective rate for income taxes was 34%, 27%, and 35% for fiscal 2008, 2007, and 2006,
respectively. Both the increase in the effective tax rate for fiscal 2008 and the decrease in the
effective tax rate for fiscal 2007 were primarily attributable to a discrete adjustment to tax
reserves in the third quarter of fiscal 2007 in the amount of $2,425,000. This discrete adjustment
reduced the effective tax rate for fiscal 2007 by 7 points. See Note 5 to the consolidated
financial statements included herein for a complete discussion of this matter.
Effective October 1, 2007, we adopted FASB Interpretation No. 48, Accounting for Uncertainty in
Income Taxes (FIN 48). FIN 48 prescribes 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 cumulative effect of adopting FIN 48, $305,000, was
charged to opening retained earnings. See Note 5 to the consolidated financial statements herein.
Impact of Inflation
To the extent feasible, we have consistently followed the practice of adjusting our prices to
reflect the impact 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 our gross margin, revenue or operating income in fiscal 2008, 2007 or 2006.
Liquidity and Capital Resources:
Comparative Cash Flow Analysis
Our cash flow and financing requirements are determined by analyses of operating and capital
spending budgets, consideration of acquisition plans, and consideration of common share dividends.
We have historically maintained a credit facility to augment working capital requirements and to
respond quickly to acquisition opportunities. This credit facility has been supplemented by the
proceeds from a September 2005 common share offering, which during the course of fiscal 2008, were
invested in fixed income securities such
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as overnight repurchase agreements, institutional money-market mutual funds, municipal variable
rate demand notes with a seven-day put feature and tax-exempt auction-rate securities.
We have an investment policy that guides the holdings of our investment portfolio. 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 policys investment
eligibility criteria. As a result of current conditions in the financial markets, during October
2008, we moved substantially all of our investments in municipal variable rate demand notes to
institutional money market mutual funds invested in either US Treasuries, or repurchase agreements
collateralized by US Treasuries. Existing investments in institutional tax-exempt money market
mutual funds are covered under the US Treasurys Temporary Guarantee Program for Money Market
Funds. This program provides a guarantee to money market mutual fund shareholders of $1 per share
net asset value for funds invested as of September 19, 2008, if the fund were to liquidate its
assets as a result of its net asset value falling below $0.995. As we look forward, we will
continue to manage the holdings of our investment portfolio with preservation of capital being the
primary objective.
We do not expect current conditions in the financial markets, or overall economic conditions to
have a significant impact on our liquidity needs, financial condition, or results of operations.
We intend to continue to fund our working capital requirements and dividends from current cash
flows from operating activities. We also have additional sources of liquidity through our
investment portfolio and $30,000,000 bank credit facility, if needed. To date, we have not
experienced any significant deterioration in the aging of our customer accounts receivable nor in
our vendors ability to supply raw materials and services and extend normal credit terms. Our
liquidity needs may change if overall economic conditions worsen and/or liquidity and credit within
the financial markets remains tight for an extended period of time, and such conditions impact the
collectability of our customer accounts receivable, impact credit terms with our vendors or disrupt
the supply of raw materials and services.
Overall stock market valuations have significantly declined in recent months, which may raise
questions around the potential impairment of goodwill and other long-lived assets. Our annual
goodwill impairment review under SFAS No. 142, Goodwill and Other Intangible Assets, takes place as
of June 30th each year. There have been no impairments from these annual reviews.
Despite the overall decline in stock market valuations, as of October 31, 2008, our stock price was
$24.58 per share, compared to our book value per share of $3.19 as of September 30, 2008. This
relationship, stock price trading at 7.7x book value, is an indicator that the decline in overall
stock market valuations, and its impact on our stock price, has not been a triggering event for
impairment of our goodwill and other long-lived assets.
Net cash provided by operating activities increased 12% to $29,883,000 in fiscal 2008. This
increase was primarily attributable to higher earnings levels, somewhat offset by prepaid taxes of
$1,007,000 and other
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changes in working capital items related to higher sales levels in fiscal 2008. The discrete tax
reserve adjustment in fiscal 2007 in the amount of $2,425,000 was non-cash in nature.
Net cash used in investing activities was $13,230,000 for fiscal 2008, compared to $443,000 for
fiscal 2007. This increase was primarily attributable to purchases of property, plant, and
equipment, purchases of investments, and purchases of intangible assets related to patents and an
acquired recombinant viral protein product line.
Net cash used in financing activities was $16,693,000 for fiscal 2008, compared to $13,291,000 for
fiscal 2007. This increase was primarily attributable to a 34% increase in dividend payments,
offset by $1,989,000 in additional proceeds and tax benefits from the exercise of stock options.
Dividend payments in fiscal 2008 reflect increased dividend rates and common shares outstanding
related to stock option exercises.
Net cash flows from operating activities are anticipated to fund working capital requirements and
dividends during the next twelve months.
Capital Resources
We have a $30,000,000 credit facility with a commercial bank which expires September 15, 2012.
As of November 26, 2008, there were no borrowings outstanding under this facility.
As of September 30, 2006, Meridian had outstanding $1,803,000 principal amount of 5% debentures,
convertible, at the option of the holder, into common shares at a price of $6.45. During fiscal
2007, these debentures were either converted into common shares at the direction of the holders or
redeemed by Meridian.
Our acquisition of Viral Antigens in fiscal 2000 provided for additional purchase consideration,
contingent upon Viral Antigens future earnings through September 30, 2006. Final earnout
consideration in the amount of $853,000 relating to fiscal 2006 was paid from operating cash
flows during the second quarter of fiscal 2007.
Our acquisition of OEM Concepts in fiscal 2005 provides for additional purchase consideration up to
a maximum remaining amount of $1,814,000, contingent upon future calendar-year sales and gross
profit of OEM Concepts products through December 31, 2008. Earnout consideration is payable each
year, following the period earned. Earnout consideration in the amount of $157,000 related to
calendar 2007 was paid from operating cash flows during the second quarter of fiscal 2008. Earnout
consideration in the amount of $3,000 for the first nine months of calendar 2008 is accrued in the
accompanying consolidated balance sheet.
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Our capital expenditures are estimated to be approximately $4,000,000 to $5,000,000 for fiscal
2009, and may be funded with cash and equivalents on hand, operating cash flows, and/or
availability under the $30,000,000 credit facility discussed above. Capital expenditures relate
to manufacturing and other equipment of a normal and recurring nature, as well as completion of
our facility expansion in Saco, Maine.
Student Loan Auction-Rate Securities
Our investment portfolio includes student loan auction-rate securities with a par value amount of
$7,750,000, which are long-term student loan revenue bonds whose interest rates are reset every 35
days via a Dutch auction process. All of our auction-rate securities are backed by pools of
student loans originated under the Federal Family Education Loan Program (FFELP). FFELP student
loans are guaranteed by state guarantors who have reinsurance agreements with the US Department of
Education. All of our student loan auction-rate securities were rated Aaa and AAA by Moodys and
Standard & Poors, respectively, at the time of purchase, and have continued to maintain these
credit ratings through the present time.
The Dutch auction process historically provided the necessary liquidity mechanism to either
purchase or sell these securities. Beginning in mid-February 2008, liquidity issues in the US
credit markets resulted in the failure of auctions across a broad spectrum of tax-exempt
securities, including student loan revenue bonds. Auctions for the student loan revenue bonds that
we hold have continued to fail through the present time.
The consequence of a failed auction is that we do not have access to the principal amount of our
investments. Issuers are still required to make interest payments when due in the event of failed
auctions. We have not experienced any missed interest payments to date. Our most recent interest
payment date was November 3, 2008.
Our auction-rate securities were purchased through UBS Financial Services, Inc. During November
2008, we accepted an offer from UBS, AG (UBS) of Auction Rate Security Rights. These rights permit
us to require UBS between June 30, 2010 and July 2, 2012 (the exercise period) to purchase our
auction-rate securities at par value. In exchange, UBS is granted the right, at their sole
discretion, to sell or otherwise dispose of our auction-rate security investments until July 2,
2012 as long as we receive a payment of par value upon the sale or disposition. In addition, the
rights permit us to establish a demand revolving credit line in an amount equal to the par value of
the securities at a net no cost. We are still able to sell the auction-rate securities on our own,
but in such a circumstance, we would lose the par value support from UBS.
As of September 30, 2008, the carrying value of our auction-rate securities was reduced by
$270,000. We consider this adjustment to be temporary under SFAS No. 115, Accounting for Certain
Investments in Debt and Equity Securities, and accordingly, it has been recorded as a component of
other comprehensive income in shareholders equity. This adjustment was based upon a valuation
prepared by an independent appraisal firm. Our investments in student loan auction-rate securities
are included in other long-term assets in the
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accompanying consolidated balance sheet based on the maturities of the student loan revenue bonds
(2029 to 2037).
We do not believe that the recent auction failures and our inability to liquidate these investments
for some period of time will have any material impact on our ability to fund our operating
requirements, capital expenditures, dividend payments, acquisitions, if any, or other business
requirements.
Known Contractual Obligations:
Known contractual obligations and their related due dates were as follows as of September 30, 2008
(dollars in thousands):
Less than | More than | |||||||||||||||||||
Total | 1 Year | 1-3 Years | 4-5 Years | 5 Years | ||||||||||||||||
Operating leases (1) |
$ | 1,695 | $ | 602 | $ | 939 | $ | 154 | $ | | ||||||||||
Purchase obligations (2) |
13,179 | 12,793 | 386 | | | |||||||||||||||
OEM Concepts earnout (3) |
1,814 | 1,814 | | | | |||||||||||||||
FIN 48 liability and
interest(4) |
779 | 779 | | | | |||||||||||||||
Total |
$ | 17,467 | $ | 15,988 | $ | 1,325 | $ | 154 | $ | | ||||||||||
(1) | Meridian and its subsidiaries are lessees of (i) office and warehouse buildings in Florida, Belgium, and France; (ii) automobiles for use by the diagnostic direct sales forces in the US and Europe; and (iii) certain office equipment such as facsimile machines and copier machines across all business units, under operating lease agreements that expire at various dates. | |
(2) | Meridians purchase obligations are primarily outstanding purchase orders for inventory and service items. These contractual commitments are not in excess of expected production requirements over the next twelve months. | |
(3) | OEM Concepts earnout obligation is contingent upon future calendar-year sales and gross profit of OEM Concepts products through December 31, 2008. | |
(4) | As of September 30, 2008, our FIN 48 liability and FIN 48 net interest payable were $731,000 and $48,000, respectively. 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 (1% to 8%). Meridian expects that payments under
these agreements will amount to as much as $514,000 in fiscal 2009. These royalty payments
primarily relate to the US Diagnostics operating segment.
During October 2006, Meridian entered into a license agreement with Eiken Chemical Co., Ltd., that
provides rights to Eikens loop-mediated isothermal amplification technology for infectious disease
testing in the United States and 18 other geographic markets. The agreement calls for payments of
up to 200,000,000 Japanese Yen (approximately $1,889,000) based on the achievement of certain
milestones and on-going royalties once products are available for commercial sale. Payments made
during product development are expected to occur over a five-year period, which began in fiscal
2007. A payment equal to 20,000,000 Japanese Yen or $169,000 was made during fiscal 2007.
During the fourth quarter of fiscal 2007, we began seeking recovery of approximately $1,400,000 of
past royalties paid and interest under a license agreement around certain rapid diagnostic testing
technology. This license agreement covered patent rights that were narrowed in scope via other
litigation with the licensor that did not involve Meridian. We strongly believe that the licensed
patent, as reissued, does not cover any of our products. We also ceased further royalty payments
under this license agreement. The licensor to this agreement disputes our position that the
patent, as reissued, does not cover our products. Although we believe that our position is very
strong, we are unable to predict the outcome of this matter. No provision has been made in the
accompanying financial statements for on-going royalties, if any, nor has any accrual or income
been recorded for recovery of past royalties paid.
Derivative financial instruments
Meridian accounts for its derivative financial instruments in accordance with SFAS No. 133,
Accounting for Derivative Instruments and Hedging Activities, as amended. These instruments are
designated as cash flow hedges, and therefore, the effective portion of the net gain or loss on the
derivative instrument is reported as a component of accumulated other comprehensive income (loss)
and reclassified into earnings in the same period or periods during which the hedged transaction
affects earnings. For the ineffective portion of the hedge, gains or losses are charged to
earnings in the current period. All derivative instruments are recognized as either assets or
liabilities at fair value in the consolidated balance sheets. See Note 4 to the consolidated
financial statements contained herein.
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Off-balance sheet arrangements
We have no off-balance sheet arrangements.
Market Risk Exposure:
Foreign Currency Risk
We have market risk exposure related to foreign currency transactions. Meridian is exposed to
foreign currency risk related to its European distribution operations, including foreign currency
denominated intercompany sales and receivables. We enter into forward exchange contracts to hedge
cash flows from intercompany sales between our US parent company and its Italian affiliate. The
counterparties to these contracts are commercial banks. Hedging activities are further discussed
in Note 4 to the consolidated financial statements.
Concentration of Customers/Products Risk
Our US Diagnostic operating segments sales through two distributors were 54% of the US Diagnostics
operating segments total sales for fiscal 2008 or 34% of consolidated total sales for fiscal 2008.
Three internally developed products, Premierä Platinum HpSA PLUS, Premierä Toxins A &
B, and ImmunoCardÒ Toxins A & B, accounted for 38% of our US Diagnostics operating
segments third-party sales during fiscal 2008. These same three products accounted for 30% of our
European Diagnostics operating segments third-party sales and 32% of our total consolidated sales
for fiscal 2008.
Our Life Science operating segments sales of purified antigens and reagents to one customer were
21% of the Life Science operating segments total sales for fiscal 2008 or 3% of our consolidated
total sales for fiscal 2008. Our Life Science operating segment has three other significant
customers who purchase antigens, antibodies and reagents, which together comprised 17% of the
operating segments total sales for fiscal 2008.
Critical Accounting Policies:
The consolidated financial statements included in this Annual Report on Form 10-K have been
prepared in accordance with accounting principles generally accepted in the United States. 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.
Management believes that the following accounting policies are critical to understanding the
accompanying consolidated financial statements because the 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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Revenue Recognition
Our revenues are derived primarily from product sales. Revenue is generally recognized when
product is shipped and title has passed to the buyer. Revenue for the US Diagnostics operating
segment is reduced at the date of sale for estimated rebates that will be claimed by customers.
Rebate agreements are in place with certain independent national distributors and are designed to
reimburse such distributors for their cost in handling Meridians products. Management estimates
rebate accruals based on historical statistics, current trends, and other factors. Changes to
these rebate accruals are recorded in the period that they become known.
Life Science revenue for contract services may come from standalone arrangements for process
development and/or optimization work (contract research and development services) or custom
manufacturing, or multiple-deliverable arrangements that include process development work followed
by larger-scale manufacturing (both contract research and development services and contract
manufacturing services). Revenue is recognized based on the nature of the arrangements, using the
principles in EITF 00-21, Revenue Arrangements with Multiple Deliverables. The framework in EITF
00-21 is based on each of the multiple deliverables in a given arrangement having distinct and
separate fair values. Fair values are determined via consistent pricing between standalone
arrangements and multiple deliverable arrangements, as well as a competitive bidding process.
Contract research and development services may be performed on a time and materials basis or
fixed fee basis. For time and materials arrangements, revenue is recognized as services are
performed and billed. For fixed fee arrangements, revenue is recognized upon completion and
acceptance by the customer. For contract manufacturing services, revenue is generally recognized
upon delivery of product and acceptance by the customer. In some cases, customers may request that
we store on their behalf clinical grade biologicals that we produce under contract manufacturing
agreements. These cases arise when customers do not have clinical grade storage facilities or do
not want to risk contamination during transport. For such cases, revenue may be recognized on a
bill-and-hold basis pursuant to the satisfaction of criteria in SEC Staff Accounting Bulletins Nos.
101 and 104 related to bill-and-hold revenue recognition.
Inventories
Our inventories are carried at the lower of cost or market. Cost is determined on a first-in,
first-out basis. 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.
Management estimates 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. Such adjustments would
negatively affect gross profit margin and overall results of operations.
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Intangible Assets
Our intangible assets include identifiable intangibles and goodwill. Identifiable intangibles
include customer lists, supply agreements, manufacturing technologies, patents, licenses, and trade
names. All of Meridians identifiable intangibles have finite lives.
SFAS No. 142 provides that goodwill and intangible assets with indefinite lives are subject to an
annual impairment review (or more frequently if impairment indicators arise) by applying a
fair-value based test. There have been no impairments from the analyses required by SFAS No. 142.
Identifiable intangibles with finite lives are subject to impairment testing as prescribed by SFAS
No. 144, Accounting for the Impairment or Disposal of Long-lived Assets. Pursuant to the
provisions of SFAS No. 144, identifiable intangibles with finite lives are reviewed for impairment
when events or circumstances indicate that such assets may not be recoverable at their current
carrying value. Whether an event or circumstance triggers impairment is determined by comparing an
estimate of the assets undiscounted future cash flows to its carrying value. If impairment has
occurred, it is measured by a fair-value based test. During fiscal 2006, Meridian determined that
the carrying value of a supply contract related to the Life Science operating segment had become
impaired and recorded such impairment in the amount of $826,000 to general and administrative
expenses. The contract provided for the supply of biological materials to the United States
Department of Defense. Changes in the Departments Critical Reagents Program lowered the amount of
materials to be supplied under the contract and ultimately led to the contract having a shorter
life than originally expected. There were no events or circumstances in fiscal 2008 or 2007
indicating that the carrying value of other such assets may not be recoverable.
Our ability to recover intangible assets, both identifiable intangibles and goodwill, is dependent
upon the future cash flows of the related acquired businesses and assets. The application of SFAS
Nos. 142 and 144 requires management to make judgments and assumptions regarding future cash flows,
including sales levels, gross profit margins, operating expense levels, working capital levels, and
capital expenditures. With respect to identifiable intangibles, management also makes judgments
and assumptions regarding useful lives.
Management considers 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) sales 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, impairment of intangible assets could
take place. If impairment were to occur, this would negatively affect overall results of
operations.
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Income Taxes
Pursuant to SFAS No. 109, Accounting for Income Taxes, our 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 tax 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 years estimates.
Effective October 1, 2007, we adopted FIN 48, which prescribes 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 cumulative effect of
adopting FIN 48, $305,000, was charged to opening retained earnings. See Note 5 to the
consolidated financial statements herein.
Our deferred tax assets include net operating loss carryforwards in foreign jurisdictions. The
realization of tax benefits related to net operating loss carryforwards is dependent upon the
generation of future taxable income in the applicable jurisdictions. Management assesses the level
of deferred tax asset valuation allowance by taking into consideration historical and future
projected operating results, future reversals of taxable temporary differences, as well as tax
planning strategies. The amount of net deferred tax assets considered realizable could be reduced
in future years if estimates of future taxable income during the carryforward period are reduced.
Undistributed earnings in our Italian subsidiary are considered by management to be permanently
re-invested in such subsidiary. Consequently, US deferred tax liabilities on such earnings have
not been recorded. Management believes that such US taxes would be largely offset by foreign tax
credits for taxes paid locally in Italy.
From time to time, our tax returns in federal, state, and foreign jurisdictions are examined by the
applicable tax authorities. To the extent that adjustments result from the completion of these
examinations or the passing 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 financial condition or results of operation.
Recent Accounting Pronouncements:
See Note 1(p) to the Consolidated Financial Statements.
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ITEM 7A.
QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
See Market Risk Exposure and Capital Resources under Item 7 above.
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ITEM 8.
FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
Index to Consolidated Financial Statements
42 | ||||
43 | ||||
45 | ||||
46 | ||||
47 | ||||
49 | ||||
50 | ||||
79 |
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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Managements 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 Companys 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 Companys 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 or 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 based on the framework and criteria in Internal Control
Integrated Framework, issued by the Committee of Sponsoring Organizations of the Treadway
Commission (COSO). Based on managements evaluation and those criteria, the Company concluded that
its system of internal control over financial reporting was effective as of September 30, 2008.
The companys independent registered public accounting firm has issued an attestation report on the
registrants internal control over financial reporting.
/s/ John A. Kraeutler
Chief Executive Officer
November 24, 2008
Chief Executive Officer
November 24, 2008
/s/ Melissa Lueke
Melissa Lueke
Vice President and
Chief Financial Officer
November 24, 2008
Melissa Lueke
Vice President and
Chief Financial Officer
November 24, 2008
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REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
Board of Directors and Shareholders
Meridian Bioscience, Inc.
Meridian Bioscience, Inc.
We have audited the accompanying consolidated balance sheets of Meridian Bioscience, Inc. (an Ohio
corporation) and subsidiaries as of September 30, 2008 and 2007, and the related consolidated
statements of operations, shareholders equity, and cash flows for each of the three years in the
period ended September 30, 2008. Our audits of the basic financial statements included the
financial statement schedule listed in the index appearing under Schedule No. II. We also have
audited Meridian Bioscience, Inc.s internal control over financial reporting as of September 30,
2008, based on criteria established in Internal ControlIntegrated Framework issued by the
Committee of Sponsoring Organizations of the Treadway Commission (COSO). Meridian Bioscience,
Inc.s management is responsible for these financial statements and financial statement schedule,
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
Managements Report on Internal Control over Financial Reporting. Our responsibility is to express
an opinion on these financial statements and financial statement schedule and an opinion on the
Companys internal control over financial reporting based on our audits.
We conducted our audits in accordance with the standards of the Public Company Accounting Oversight
Board (United States). Those standards require that we plan and perform the audits to obtain
reasonable assurance about whether the financial statements are free of material misstatement and
whether effective internal control over financial reporting was maintained in all material
respects. Our audits of the financial statements included examining, on a test basis, evidence
supporting the amounts and disclosures in the financial statements, assessing the accounting
principles used and significant estimates made by management, and evaluating the overall financial
statement presentation. Our audit of internal control over financial reporting included obtaining
an understanding of internal control over financial reporting, assessing the risk that a material
weakness exists, and testing and evaluating the design and operating effectiveness of internal
control based on the assessed risk. Our audits also included performing such other procedures as
we considered necessary in the circumstances. We believe that our audits provide a reasonable
basis for our opinions.
A companys 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
companys 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
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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 companys 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.
In our opinion, the financial statements referred to above present fairly, in all material
respects, the financial position of Meridian Bioscience, Inc. and subsidiaries as of September 30,
2008 and 2007, and the results of their operations and their cash flows for each of the three years
in the period ended September 30, 2008 in conformity with accounting principles generally accepted
in the United States of America. Also, in our opinion, the related financial statement schedule,
when considered in relation to the basic financial statements taken as a whole, presents fairly, in
all material respects, the information set forth therein.
Also in our opinion, Meridian Bioscience, Inc. and subsidiaries maintained, in all material
respects, effective internal control over financial reporting as of September 30, 2008, based on
criteria established in Internal ControlIntegrated Framework issued by COSO.
We do not express an opinion or any other form of assurance on Managements Report on Internal
Control over Financial Reporting.
/s/ GRANT THORNTON LLP
Cincinnati, OH
November 24, 2008
Cincinnati, OH
November 24, 2008
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CONSOLIDATED STATEMENTS OF OPERATIONS (in thousands, except per share data)
Meridian Bioscience, Inc. and Subsidiaries
Meridian Bioscience, Inc. and Subsidiaries
For the Year Ended September 30, | 2008 | 2007 | 2006 | |||||||||
Net Sales |
$ | 139,639 | $ | 122,963 | $ | 108,413 | ||||||
Cost of Sales |
53,159 | 48,023 | 43,729 | |||||||||
Gross Profit |
86,480 | 74,940 | 64,684 | |||||||||
Operating Expenses: |
||||||||||||
Research and development |
6,183 | 6,085 | 4,799 | |||||||||
Selling and marketing |
18,770 | 17,124 | 16,698 | |||||||||
General and administrative |
17,177 | 16,701 | 16,293 | |||||||||
Total operating expenses |
42,130 | 39,910 | 37,790 | |||||||||
Operating Income |
44,350 | 35,030 | 26,894 | |||||||||
Other Income (Expense): |
||||||||||||
Interest income |
1,533 | 1,642 | 1,123 | |||||||||
Interest expense |
| (38 | ) | (128 | ) | |||||||
Other, net |
109 | 48 | 177 | |||||||||
Total other income |
1,642 | 1,652 | 1,172 | |||||||||
Earnings Before Income Taxes |
45,992 | 36,682 | 28,066 | |||||||||
Income Tax Provision |
15,790 | 9,961 | 9,733 | |||||||||
Net Earnings |
$ | 30,202 | $ | 26,721 | $ | 18,333 | ||||||
Earnings Per Share Data: |
||||||||||||
Basic earnings per common share |
$ | 0.75 | $ | 0.67 | $ | 0.47 | ||||||
Diluted earnings per common share |
0.74 | 0.66 | 0.46 | |||||||||
Common shares used for basic earnings per common share |
40,093 | 39,584 | 39,132 | |||||||||
Effect of dilutive stock options |
936 | 1,154 | 1,032 | |||||||||
Common shares used for diluted earnings per common share |
41,029 | 40,738 | 40,164 | |||||||||
Dividends declared per common share |
$ | 0.53 | $ | 0.40 | $ | 0.28 | ||||||
Anti-dilutive Securities: |
||||||||||||
Common share options |
67 | | 32 | |||||||||
Convertible debentures |
| | 279 | |||||||||
All share and per share data has been adjusted for a three-for-two stock split that occurred on May
11, 2007.
The accompanying notes are an integral part of these consolidated financial statements.
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CONSOLIDATED STATEMENTS OF CASH FLOWS (dollars in thousands)
Meridian Bioscience, Inc. and Subsidiaries
For the Year Ended September 30, | 2008 | 2007 | 2006 | |||||||||
Cash Flows From Operating Activities |
||||||||||||
Net earnings |
$ | 30,202 | $ | 26,721 | $ | 18,333 | ||||||
Non-cash items: |
||||||||||||
Depreciation of property, plant and equipment |
2,857 | 2,764 | 2,717 | |||||||||
Amortization of intangible assets and debt issuance costs |
1,612 | 1,635 | 2,572 | |||||||||
Deferred income taxes |
976 | 800 | 47 | |||||||||
Stock compensation expense |
1,772 | 2,632 | 1,082 | |||||||||
Tax reserve adjustment |
| (2,425 | ) | | ||||||||
Loss on disposition of fixed assets |
9 | 5 | 38 | |||||||||
Change in current assets |
(5,147 | ) | (3,011 | ) | (3,146 | ) | ||||||
Change in current liabilities |
(2,967 | ) | (2,145 | ) | 920 | |||||||
Other, net |
569 | (374 | ) | (408 | ) | |||||||
Net cash provided by operating activities |
29,883 | 26,602 | 22,155 | |||||||||
Cash Flows From Investing Activities |
||||||||||||
Acquisition earnout payments |
(157 | ) | (971 | ) | (1,494 | ) | ||||||
Purchases of property, plant and equipment |
(4,219 | ) | (3,211 | ) | (3,120 | ) | ||||||
Proceeds from dispositions of property, plant and equipment |
4 | 4 | 47 | |||||||||
Purchases of investments |
(7,750 | ) | | (6,000 | ) | |||||||
Proceeds from sales of investments |
| 4,000 | 2,000 | |||||||||
Other intangibles acquired |
(1,108 | ) | (265 | ) | (122 | ) | ||||||
Net cash used in investing activities |
(13,230 | ) | (443 | ) | (8,689 | ) | ||||||
Cash Flows From Financing Activities |
||||||||||||
Repayment of debt obligations |
| (29 | ) | (790 | ) | |||||||
Dividends paid |
(21,256 | ) | (15,836 | ) | (11,095 | ) | ||||||
Proceeds and tax benefits from exercises of stock options |
4,563 | 2,574 | 1,660 | |||||||||
Net cash used in financing activities |
(16,693 | ) | (13,291 | ) | (10,225 | ) | ||||||
Effect of Exchange Rate Changes on Cash and Equivalents |
(63 | ) | 184 | 22 | ||||||||
Net Increase in Cash and Equivalents |
(103 | ) | 13,052 | 3,263 | ||||||||
Cash and Equivalents at Beginning of Period |
49,400 | 36,348 | 33,085 | |||||||||
Cash and Equivalents at End of Period |
$ | 49,297 | $ | 49,400 | $ | 36,348 | ||||||
The accompanying notes are an integral part of these consolidated financial statements.
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CONSOLIDATED BALANCE SHEETS (dollars in thousands)
Meridian Bioscience, Inc. and Subsidiaries
As of September 30, | 2008 | 2007 | ||||||
Assets |
||||||||
Current Assets: |
||||||||
Cash and equivalents |
$ | 49,297 | $ | 49,400 | ||||
Accounts receivable, less allowances of $230 in 2008 and $258 in 2007 |
25,098 | 22,651 | ||||||
Inventories |
19,945 | 18,171 | ||||||
Prepaid expenses and other current assets |
3,382 | 2,147 | ||||||
Deferred income taxes |
1,736 | 1,376 | ||||||
Total current assets |
99,458 | 93,745 | ||||||
Property, Plant and Equipment, at Cost: |
||||||||
Land |
892 | 890 | ||||||
Buildings and improvements |
16,977 | 16,907 | ||||||
Machinery, equipment and furniture |
26,458 | 24,619 | ||||||
Construction in progress |
3,391 | 1,290 | ||||||
Subtotal |
47,718 | 43,706 | ||||||
Less-accumulated depreciation and amortization |
28,043 | 25,395 | ||||||
Net property, plant and equipment |
19,675 | 18,311 | ||||||
Other Assets: |
||||||||
Goodwill |
9,861 | 9,964 | ||||||
Other intangible assets, net |
8,786 | 9,457 | ||||||
Restricted cash |
1,000 | 1,000 | ||||||
Investments in auction-rate securities |
7,480 | | ||||||
Other assets |
171 | 221 | ||||||
Total other assets |
27,298 | 20,642 | ||||||
Total assets |
$ | 146,431 | $ | 132,698 | ||||
The accompanying notes are an integral part of these consolidated financial statements.
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CONSOLIDATED BALANCE SHEETS (dollars in thousands)
Meridian Bioscience, Inc. and Subsidiaries
As of September 30, | 2008 | 2007 | ||||||
Liabilities and Shareholders Equity |
||||||||
Current Liabilities: |
||||||||
Accounts payable |
$ | 4,777 | $ | 4,704 | ||||
Accrued payroll costs |
6,777 | 7,541 | ||||||
Purchase business combination liability |
3 | 152 | ||||||
Other accrued expenses |
3,613 | 4,008 | ||||||
Income taxes payable |
891 | 662 | ||||||
Total current liabilities |
16,061 | 17,067 | ||||||
Deferred Income Taxes |
1,881 | 2,683 | ||||||
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, 40,313,656
and 39,847,391 shares issued |
| | ||||||
Additional paid-in capital |
89,107 | 82,209 | ||||||
Retained earnings |
39,016 | 30,375 | ||||||
Accumulated other comprehensive income |
366 | 364 | ||||||
Total shareholders equity |
128,489 | 112,948 | ||||||
Total liabilities and shareholders equity |
$ | 146,431 | $ | 132,698 | ||||
The accompanying notes are an integral part of these consolidated financial statements.
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CONSOLIDATED STATEMENTS OF SHAREHOLDERS EQUITY (Dollars and shares in thousands except per share data)
Meridian Bioscience, Inc. and Subsidiaries
Additional | Accumulated Other | |||||||||||||||||||||||||||||||
Common | Shares Held | Treasury | Paid-in | Retained | Comprehensive | Comprehensive | ||||||||||||||||||||||||||
Shares Issued | in Treasury | Stock | Capital | Earnings | Income (Loss) | Income (Loss) | Total | |||||||||||||||||||||||||
Balance at September 30, 2005 |
38,910 | (18) | $ | (32) | $ | 71,568 | $ | 12,252 | $ | (455) | $ | 83,333 | ||||||||||||||||||||
Cash dividends paid $0.28 per share |
| | | | (11,095) | | (11,095) | |||||||||||||||||||||||||
Exercise of stock options |
245 | | | 1,722 | | | 1,722 | |||||||||||||||||||||||||
Stock compensation expense |
| | | 1,082 | | | 1,082 | |||||||||||||||||||||||||
Debenture conversions |
99 | | | 610 | | | 610 | |||||||||||||||||||||||||
Retirement of treasury shares |
(18) | 18 | 32 | (32) | | | | |||||||||||||||||||||||||
Comprehensive income: |
||||||||||||||||||||||||||||||||
Net earnings |
| | | | 18,333 | | $ | 18,333 | 18,333 | |||||||||||||||||||||||
Hedging activity |
| | | | | 13 | 13 | 13 | ||||||||||||||||||||||||
Other comprehensive income taxes |
| | | | | 50 | 50 | 50 | ||||||||||||||||||||||||
Foreign currency translation adjustment |
| | | | | 302 | 302 | 302 | ||||||||||||||||||||||||
Comprehensive income |
$ | 18,698 | ||||||||||||||||||||||||||||||
Balance at September 30, 2006 |
39,236 | | | 74,950 | 19,490 | (90) | 94,350 | |||||||||||||||||||||||||
Cash dividends paid $0.40 per share |
| | | | (15,836) | | (15,836) | |||||||||||||||||||||||||
Exercise of stock options |
336 | | | 2,950 | | | 2,950 | |||||||||||||||||||||||||
Stock compensation expense |
| | | 2,632 | | | 2,632 | |||||||||||||||||||||||||
Debenture conversions |
275 | | | 1,677 | | | 1,677 | |||||||||||||||||||||||||
Comprehensive income: |
||||||||||||||||||||||||||||||||
Net earnings |
| | | | 26,721 | | $ | 26,721 | 26,721 | |||||||||||||||||||||||
Hedging activity |
| | | | | (283) | (283) | (283) | ||||||||||||||||||||||||
Other comprehensive income taxes |
| | | | | (244) | (244) | (244) | ||||||||||||||||||||||||
Foreign currency translation adjustment |
| | | | | 981 | 981 | 981 | ||||||||||||||||||||||||
Comprehensive income |
$ | 27,175 | ||||||||||||||||||||||||||||||
Balance at September 30, 2007 |
39,847 | | | 82,209 | 30,375 | 364 | 112,948 | |||||||||||||||||||||||||
Adoption of FASB Interpretation No. 48 |
| | | | (305) | | (305) | |||||||||||||||||||||||||
Cash dividends paid $0.53 per share |
| | | | (21,256) | | (21,256) | |||||||||||||||||||||||||
Exercise of stock options |
467 | | | 5,126 | | | 5,126 | |||||||||||||||||||||||||
Stock compensation expense |
| | | 1,772 | | | 1,772 | |||||||||||||||||||||||||
Comprehensive income: |
||||||||||||||||||||||||||||||||
Net earnings |
| | | | 30,202 | $ | 30,202 | 30,202 | ||||||||||||||||||||||||
Hedging activity |
| | | | | 273 | 273 | 273 | ||||||||||||||||||||||||
Unrealized loss on investments |
| | | | | (270) | (270) | (270) | ||||||||||||||||||||||||
Other comprehensive income taxes |
| | | | | (4) | (4) | (4) | ||||||||||||||||||||||||
Foreign currency translation adjustment |
| | | | | 3 | 3 | 3 | ||||||||||||||||||||||||
Comprehensive income |
$ | 30,204 | ||||||||||||||||||||||||||||||
Balance at September 30, 2008 |
40,314 | | $ | | $ | 89,107 | $ | 39,016 | $ | 366 | $ | 128,489 | ||||||||||||||||||||
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
(1) Summary of Significant Accounting Policies
(a) | Nature of Business Meridian is a fully-integrated life science company whose principal businesses are (i) the development, manufacture and distribution of diagnostic test kits primarily for certain respiratory, gastrointestinal, viral and parasitic infectious diseases, (ii) the manufacture and distribution of bulk antigens, antibodies, and reagents used by researchers and other diagnostic manufacturers and (iii) the contract development and manufacture of proteins and other biologicals for use by biopharmaceutical and biotechnology companies engaged in research for new drugs and vaccines. |
(b) | Principles of Consolidation The consolidated financial statements include the accounts of Meridian Bioscience, Inc. and its subsidiaries. All significant intercompany accounts and transactions have been eliminated. Unless the context requires otherwise, references to Meridian, we, us, our, or our company refer to Meridian Bioscience, Inc. and its subsidiaries. |
(c) | Use of Estimates The preparation of financial statements in conformity with generally accepted accounting principles 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 financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. Significant estimates are discussed in Notes 1(f), 1(g), 1(h), 1(i), 1(k), 1(l), 5 and 6(b). |
(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 in a separate component of accumulated other comprehensive income or loss. 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 Euro currency. These gains and losses are included in other income and expense in the accompanying consolidated statements of operations. |
(e) | Cash, Cash Equivalents and Investments We consider short-term investments with original maturities of 90 days or less to be cash equivalents, including overnight repurchase agreements, investments in municipal variable rate demand notes that have a seven-day put feature and institutional money market funds. | |
Our investments in debt securities are accounted for as available-for-sale under SFAS No. 115, Accounting for Certain Investments in Debt and Equity Securities. As such, unrealized holding gains and losses are reported as a component of other comprehensive income or loss within shareholders equity until realized, |
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except where losses are considered to be other-than-temporary, in which case they would be recorded to other income and expense, net. The carrying value of securities classified as cash equivalents was equal to their fair value as of September 30, 2008 and 2007. There were no realized gains or losses from the sales of securities classified as cash equivalents during fiscal 2008 or fiscal 2007. As of September 30, 2008, accumulated other comprehensive income included $270,000 of current year unrealized holding losses related to student loan auction-rate securities, which are discussed below. |
Our investment portfolio includes the following components (dollars in thousands): |
September 30, 2008 | September 30, 2007 | |||||||||||||||
Cash and | Other | Cash and | Other | |||||||||||||
Equivalents | Assets | Equivalents | Assets | |||||||||||||
Taxable investments |
||||||||||||||||
Repurchase agreements |
$ | 6,711 | $ | 7,751 | ||||||||||||
Tax-exempt investments |
||||||||||||||||
Money market funds |
12,848 | 2,536 | ||||||||||||||
Variable rate demand notes |
23,948 | 36,069 | ||||||||||||||
Student loan auction-rate securities |
| $ | 7,480 | | ||||||||||||
Cash on hand |
||||||||||||||||
Restricted |
| 1,000 | | $ | 1,000 | |||||||||||
Unrestricted |
5,790 | | 3,044 | | ||||||||||||
Total |
$ | 49,297 | $ | 8,480 | $ | 49,400 | $ | 1,000 | ||||||||
The primary objectives of our investment activities are to preserve capital and provide sufficient liquidity to meet operating requirements and fund strategic initiatives such as acquisitions. We maintain a written investment policy that governs the management of our investments in fixed income securities. This policy, among other things, provides that we may purchase only high credit-quality securities, that have short-term ratings of at least A-1 and P-1 or better, and long-term ratings of at least A-2 and A or better, by Moodys and Standard & Poors, respectively, at the time of purchase. | ||
Our investments in repurchase agreements are with a commercial bank pursuant to an overnight sweep/liquidity arrangement with our operating cash accounts. Our investments in variable rate demand notes contain a seven-day put feature. | ||
As a result of current conditions in the financial markets, during October 2008, we moved substantially all of our investments in municipal variable rate demand notes to institutional money market mutual funds invested in either US Treasuries, or repurchase agreements collateralized by US Treasuries. Existing investments in institutional tax-exempt money market mutual funds are covered under the US Treasurys Temporary Guarantee Program for Money Market Funds. This program provides a guarantee to money market mutual |
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fund shareholders of $1 per share net asset value for funds invested as of September 19, 2008, if the fund were to liquidate its assets as a result of its net asset value falling below $0.995. | ||
Our investment portfolio also includes student loan auction-rate securities, which are long-term student loan revenue bonds whose interest rates are reset every 35 days via a Dutch auction process. All of our auction-rate securities are backed by pools of student loans originated under the Federal Family Education Loan Program (FFELP). FFELP student loans are guaranteed by State guarantors who have reinsurance agreements with the US Department of Education. All of our student loan auction-rate securities were rated Aaa and AAA by Moodys and Standard & Poors, respectively, at the time of purchase, and have continued to maintain these credit ratings through the present time. | ||
The Dutch auction process historically provided the necessary liquidity mechanism to either purchase or sell these securities. Beginning in mid-February 2008, liquidity issues in the US credit markets resulted in the failure of auctions across a broad spectrum of tax-exempt securities, including student loan revenue bonds. Auctions for the student loan revenue bonds that we hold have continued to fail through the present time. | ||
The consequence of a failed auction is that we do not have access to the principal amount of our investments. Issuers are still required to make interest payments when due in the event of failed auctions. We have not experienced any missed interest payments to date. | ||
Our auction-rate securities were purchased through UBS Financial Services, Inc. During November 2008, we accepted an offer from UBS, AG (UBS) of Auction Rate Security Rights. These rights permit us to require UBS between June 30, 2010 and July 2, 2012 (the exercise period) to purchase our auction-rate securities at par value. In exchange, UBS is granted the right, at their sole discretion, to sell or otherwise dispose of our auction-rate security investments until July 2, 2012 as long as we receive a payment of par value upon the sale or disposition. In addition, the rights permit us to establish a demand revolving credit line in an amount equal to the par value of the securities at a net no cost. We are still able to sell the auction-rate securities on our own, but in such a circumstance, we would lose the par value support from UBS. | ||
As of September 30, 2008, the carrying value of our auction-rate securities was reduced by $270,000. We consider this adjustment to be temporary under SFAS No. 115, Accounting for Certain Investments in Debt and Equity Securities, and accordingly, it has been recorded as a component of other comprehensive income in shareholders equity. This adjustment was based upon a valuation prepared by an independent appraisal firm. Our investments in student loan auction-rate securities are included in other long-term assets in the accompanying consolidated balance sheet based on the maturities of the student loan revenue bonds (2029 to 2037). |
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We do not believe that the recent auction failures and our inability to liquidate these investments for some period of time will have any material impact on our ability to fund our operating requirements, capital expenditures, dividend payments, acquisitions, if any, or other business requirements. | ||
(f) | Inventories Inventories are stated at the lower of cost or market. Cost is determined on a first-in, first-out basis (FIFO) for substantially all of our inventories. | |
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. Such reserves were $1,103,000 and $1,162,000 at September 30, 2008 and 2007, respectively. Management estimates 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. Such adjustments would negatively affect gross profit margin and overall results of operations. | ||
Prior to July 1, 2007, the cost of certain inventories within the Life Science operating segment was determined by the last-in, first-out (LIFO) method. Effective July 1, 2007, we changed our method of accounting for this inventory from the LIFO method to the FIFO method, and now substantially all of our inventories are reflected at the lower of cost or market with cost determined by the FIFO method. We changed to the FIFO method for these inventories because: it conforms substantially all of our worldwide inventories to a consistent basis of accounting; and it provides better comparability to our industry peers, many of whom use the FIFO method of accounting for inventories. In accordance with Statement of Financial Accounting Standards (SFAS) No. 154, Accounting Changes and Error Corrections, the change in accounting has been retrospectively applied to all prior periods presented herein. The impact was not material to our results of operations or financial position. | ||
(g) | Property, Plant and Equipment Property, plant and equipment are stated at cost. Upon retirement or other disposition of property, plant and equipment, the cost and related accumulated depreciation and amortization are removed from the accounts and the resulting gain or loss is reflected in earnings. Maintenance and repairs are expensed as incurred. Depreciation and amortization are computed on the straight-line method in amounts sufficient to write-off the cost over the estimated useful lives as follows: |
Buildings
and improvements - 18 to 40 years
Machinery, equipment, and furniture - 3 to 10 years
Machinery, equipment, and furniture - 3 to 10 years
(h) | Intangible Assets and Application of SFAS Nos. 142 and 144 SFAS No. 142, Goodwill and Other Intangible Assets, addresses accounting and reporting for acquired goodwill and other intangible assets. SFAS No. 142 provides that goodwill and other intangible assets with indefinite lives are subject to an annual impairment review (or more frequently if impairment indicators arise) by applying a fair-value based |
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test. We perform our annual impairment review as of June 30, the end of our third fiscal quarter. We have no intangible assets with indefinite lives other than goodwill. There have been no impairments from the analyses prepared pursuant to SFAS No. 142. During fiscal 2008, the change in goodwill was a decrease of $103,000. This change consisted of an increase related to the OEM Concepts earnout obligations for calendar 2007 and the first nine months of calendar 2008 in the amount of $7,000 (Life Science operating segment), offset by a decrease of $110,000 related to recognition of acquired tax benefits (US Diagnostics operating segment). During fiscal 2007, the change in goodwill was an increase of $100,000. This change consisted of an increase related to the OEM Concepts earnout obligations for calendar 2006 and the first nine months of calendar 2007 in the amount of $186,000 (Life Science operating segment), offset by a decrease of $86,000 related to recognition of acquired tax benefits (US Diagnostics operating segment). |
A summary of Meridians acquired intangible assets subject to amortization, as of September 30, 2008 and 2007 is as follows (dollars in thousands). |
Wtd Avg | 2008 | 2007 | ||||||||||||||||||
Amort | Gross | 2008 | Gross | 2007 | ||||||||||||||||
Period | Carrying | Accumulated | Carrying | Accumulated | ||||||||||||||||
As of September 30, | (Yrs) | Value | Amortization | Value | Amortization | |||||||||||||||
Core products and cell lines |
15 | $ | 4,698 | $ | 2,602 | $ | 4,698 | $ | 2,313 | |||||||||||
Manufacturing technologies |
14 | 6,057 | 4,440 | 5,907 | 4,089 | |||||||||||||||
Trademarks, licenses and patents |
8 | 2,663 | 1,843 | 2,270 | 1,694 | |||||||||||||||
Customer lists and supply
agreements |
13 | 11,039 | 6,786 | 10,641 | 5,963 | |||||||||||||||
$ | 24,457 | $ | 15,671 | $ | 23,516 | $ | 14,059 | |||||||||||||
The actual aggregate amortization expense for these intangible assets for fiscal 2008, 2007, and 2006 was $1,612,000, $1,632,000, and $2,560,000, respectively. The amortization expense for fiscal 2006 included an impairment charge of $826,000 on a supply agreement discussed below. The estimated aggregate amortization expense for these intangible assets for each of the five succeeding fiscal years is as follows: fiscal 2009 - $1,574,000, fiscal 2010 - $1,412,000, fiscal 2011 - $1,297,000, fiscal 2012- $1,152,000 and fiscal 2013 - $1,152,000. | ||
SFAS No. 144, Accounting for Impairment or Disposal of Long-lived Assets, establishes a single model for accounting for impairment or disposal of long-lived assets. Long-lived assets, excluding goodwill and identifiable intangibles with indefinite lives, 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 assets future cash flows to its carrying value. If impairment has occurred, it is measured by a fair-value based test. During fiscal 2006, we determined that the carrying value of a supply contract with the US Department of Defense (the Department) related to the Life Science operating segment had become impaired and recorded such impairment in the amount of $826,000 to general and administrative expenses. The impairment was measured by comparing the present value of expected future cash flows to the carrying value of the contract. The contract provided for the supply of biological materials during a base period and also contained four optional 12-month renewal periods through March 31, 2009. Changes in the Departments Critical Reagents |
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Program lowered the amount of materials to be supplied under the contract. During March 2007, the Department informed us that it would not be exercising the optional renewal period from April 1, 2007 through March 31, 2008. We do not expect to supply any more materials under this contract, and as of September 30, 2008 and September 30, 2007, the carrying value of this contract was zero. There have been no events or circumstances indicating that the carrying value of other such assets may not be recoverable. | ||
Meridians ability to recover its intangible assets, both identifiable intangibles and goodwill, is dependent upon the future cash flows of the related acquired businesses and assets. The application of SFAS Nos. 142 and 144 requires management to make judgments and assumptions regarding future cash flows, including sales levels, gross profit margins, operating expense levels, working capital levels, and capital expenditures. With respect to identifiable intangibles and fixed assets, management also makes judgments and assumptions regarding useful lives. | ||
Management considers 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) sales 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 intangible assets and other long-lived assets. If impairment were to occur, this would negatively affect overall results of operations. | ||
(i) | Revenue Recognition Revenue is generally recognized from sales when product is shipped and title has passed to the buyer. Revenue for the US Diagnostics operating segment is reduced at the date of sale for estimated rebates that will be claimed by customers. Management estimates accruals for rebate agreements based on historical statistics, current trends, and other factors. Changes to the accruals are recorded in the period that they become known. Our rebate accruals were $3,259,000 at September 30, 2008 and $2,415,000 at September 30, 2007. | |
Life Science revenue for contract services may come from standalone arrangements for process development and/or optimization work (contract research and development services) or custom manufacturing, or multiple-deliverable arrangements that include process development work followed by larger-scale manufacturing (both contract research and development services and contract manufacturing services). Revenue is recognized based on the nature of the arrangements, using the principles in EITF 00-21, Revenue Arrangements with Multiple Deliverables. The framework in EITF 00-21 is based on each of the multiple deliverables in a given arrangement having distinct and separate fair values. Fair values are determined via consistent pricing between standalone arrangements and multiple deliverable arrangements, as well as a competitive bidding process. Contract research and development services may be performed on a time and materials basis or fixed fee basis. For time and materials arrangements, revenue is |
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recognized as services are performed and billed. For fixed fee arrangements, revenue is recognized upon completion and acceptance by the customer. For contract manufacturing services, revenue is generally recognized upon delivery of product and acceptance by the customer. In some cases, customers may request that we store on their behalf, clinical grade biologicals that we produce under contract manufacturing agreements. These cases arise when customers do not have clinical grade storage facilities or do not want to risk contamination during transport. For such cases, revenue may be recognized on a bill-and-hold basis pursuant to the satisfaction of criteria in SEC Staff Accounting Bulletins Nos. 101 and 104 related to bill-and-hold revenue recognition. |
Trade accounts receivable are recorded in the accompanying consolidated balance sheet at invoiced amounts less provisions for rebates and doubtful accounts. The allowance for doubtful accounts represents our estimate of probable credit losses and is based on historical write-off experience. The allowance for doubtful accounts and related metrics, such as days sales outstanding, are reviewed monthly. Accounts with past due balances over 90 days are reviewed individually for collectibility. Customer invoices are charged off against the allowance when we believe it is probable the invoices will not be paid. | ||
(j) | 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 clinical trials, and costs for facilities and equipment. | |
(k) | 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 tax 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 years estimates. See Note 5. | |
On October 1, 2007, we began accounting for uncertain tax positions in accordance with FASB Interpretation No. 48, Accounting for Uncertainty in Income Taxes (FIN 48). FIN 48 requires use of 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. See Note 5. | ||
(l) | Stock-based Compensation We account for stock-based compensation pursuant to SFAS No. 123R, Share-Based Payment. SFAS No. 123R requires recognition of compensation expense for all share-based |
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awards made to employees, based upon the fair value of the share-based award on the date of the grant. Meridian elected to adopt the provisions of SFAS No. 123R, utilizing the modified prospective method, which required compensation expense be measured and recognized based on grant-date fair value for stock option awards granted after July 1, 2005, our adoption date, and the non-vested portions of stock options awards granted prior to July 1, 2005. See Note 6(b). |
(m) | Derivative Financial Instruments We account for our derivative financial instruments in accordance with SFAS No. 133, Accounting for Derivative Instruments and Hedging Activities, as amended. These instruments are designated as cash flow hedges, and therefore, the effective portion of the net gain or loss on the derivative instrument is reported as a component of accumulated other comprehensive income (loss) and reclassified into earnings in the same period or periods during which the hedged transaction affects earnings. For the ineffective portion of the hedge, gains or losses are charged to earnings in the current period. All derivative instruments are recognized as either assets or liabilities at fair value in the consolidated balance sheets. Cash flows from our hedging instruments are classified in operating activities, consistent with cash flows from the related items being hedged. See Note 4. | |
(n) | Comprehensive Income (Loss) Comprehensive income (loss) represents the net change in shareholders equity during a period from sources other than transactions with shareholders. Our comprehensive income or loss is comprised of net earnings, foreign currency translation, changes in the fair value of forward exchange contracts accounted for as cash flow hedges, and changes in the fair value of available-for-sale (AFS) fixed income securities. Components of beginning and ending accumulated other comprehensive income or loss, and related activity, are shown in the following table (in thousands): |
Foreign | Accumulated | |||||||||||||||||||
Currency | Cash | Unrealized Loss | Other | |||||||||||||||||
Translation | Flow | Income | on AFS | Comprehensive | ||||||||||||||||
Adjustment | Hedges | Taxes | Securities | Income (Loss) | ||||||||||||||||
Balance at September 30, 2007 |
$ | 828 | $ | (270) | $ | (194) | $ | | $ | 364 | ||||||||||
Currency translation |
3 | | | | 3 | |||||||||||||||
Reclassifications to earnings of hedging
activity |
| 599 | | | 599 | |||||||||||||||
Net unrealized losses on hedging instruments |
| (326) | | | (326) | |||||||||||||||
Net unrealized losses on auction-rate securities |
| | | (270) | (270) | |||||||||||||||
Taxes |
| | (4) | | (4) | |||||||||||||||
Balance at September 30, 2008 |
$ | 831 | $ | 3 | $ | (198) | $ | (270) | $ | 366 | ||||||||||
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(o) | Supplemental Cash flow Information Supplemental cash flow information is as follows for fiscal 2008 , 2007 and 2006 (dollars in thousands): |
Year Ended September 30, | 2008 | 2007 | 2006 | |||||||||
Cash paid for - |
||||||||||||
Income taxes |
$ | 15,365 | $ | 12,412 | $ | 6,734 | ||||||
Interest |
| 37 | 106 | |||||||||
Non-cash items - |
||||||||||||
Debenture conversions |
| 1,775 | 648 | |||||||||
(p) | Recent Accounting Pronouncements During September 2006, the FASB issued SFAS No. 157, Fair Value Measurements. SFAS No. 157 defines fair value and provides a framework for measuring fair value, including a hierarchy that prioritizes the inputs to valuation techniques into three broad levels. This fair value hierarchy gives the highest priority to quoted prices in active markets for identical assets and liabilities and the lowest priority to unobservable inputs. We are required to adopt SFAS No. 157 in fiscal 2009. We are currently in the process of evaluating the impact of SFAS No. 157 on our financial statements. | |
During February 2007, the FASB issued SFAS 159, The Fair Value Option for Financial Assets and Financial Liabilities Including an Amendment of FASB Statement No. 115. SFAS No. 159 permits an entity to choose to measure certain financial instruments and other items at fair value where such financial instruments and other items are not currently required to be measured at fair value. For financial instruments and other items where the fair value option is elected, unrealized gains and losses are reported in earnings. We are required to adopt SFAS No. 159 in fiscal 2009. We are currently in the process of evaluating the impact of SFAS No. 159 on our financial statements. | ||
In December 2007, the FASB issued SFAS No. 141(R), Business Combinations, as part of a joint project with the International Accounting Standards Board. SFAS No. 141(R) provides for several significant changes to existing accounting practices for business combinations. Most notably, (i) acquisition-related transaction costs, such as legal and professional fees, shall be expensed rather than accounted for as part of the acquisition cost; (ii) acquired in-process research and development shall be capitalized rather than expensed at the acquisition date; and (iii) contingent consideration shall be recorded at fair value at the acquisition date rather than the points in time that payment becomes probable. SFAS No. 141(R) is effective for fiscal years beginning after December 15, 2008. Thus, for Meridian, it will affect any acquisitions completed on or after October 1, 2009. | ||
In April 2008, the FASB issued Staff Position No. 142-3, Determination of the Useful Life of Intangible Assets. This statement provides guidance on the determination of the useful life of intangible assets in accordance with SFAS No. 142. For intangible assets acquired after the effective date, a company is not required to consider renewal or extension at substantial cost or with material modification of existing terms to be factors that limit the useful life of the asset. Instead, the company must consider its own historical |
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experience in renewing or extending similar arrangements, adjusted by certain company-specific factors. FSP 142-3 is effective for fiscal years beginning after December 15, 2008 and for interim periods within those fiscal years, which, for Meridian, would be fiscal 2010. Early adoption is prohibited. We do not expect the adoption of this standard to have a material effect on our results of operations. |
In June 2008, the FASB issued SFAS No. 161, Disclosures about Derivative Instruments and Hedging Activities an amendment of FASB Statement No. 133. This statement requires additional disclosures regarding the effect of hedging activities on a companys results. This statement is effective for financial statements issued for fiscal years and interim periods beginning after November 15, 2008, which for Meridian would be the second quarter of fiscal 2009. We have elected to early-adopt this statement, as permitted. See Note 4. | ||
(q) | Shipping and Handling costs Shipping and handling costs invoiced to customers are included in net sales. Costs to distribute products to customers, including inbound freight costs, warehousing costs, and other shipping and handling activities are included in cost of goods sold. | |
(r) | 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 sales) in the accompanying consolidated statements of operations. | |
(s) | Reclassifications Certain reclassifications have been made to the prior year financial statements to conform to the current year presentation. |
(2) Inventories
Inventories are comprised of the following (dollars in thousands): |
As of September 30, | 2008 | 2007 | ||||||
Raw materials |
$ | 5,238 | $ | 4,816 | ||||
Work-in-process |
4,867 | 5,141 | ||||||
Finished goods |
9,840 | 8,214 | ||||||
$ | 19,945 | $ | 18,171 | |||||
(3) Bank Credit Arrangements
We have a $30,000,000 credit facility with a commercial bank, which expires in September 2012.
This credit facility is collateralized by our business assets except for those of non-domestic
subsidiaries. There were no borrowings outstanding on this credit facility at September 30, 2008
or September 30, 2007. Available borrowings under this credit facility were $30,000,000 at
September 30, 2008. In connection with this bank credit arrangement, we are required to comply
with financial covenants that limit the amount of debt obligations,
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require a minimum amount of
tangible net worth, and require a minimum amount of fixed charge coverage. We are in compliance
with all covenants. We are also required to maintain a cash compensating balance with the bank in
the amount of $1,000,000, pursuant to this bank credit arrangement.
(4) Hedging Transactions
From time to time, we manage exchange rate risk related to forecasted intercompany sales
denominated in the Euro currency through the use of forward exchange contracts. In accordance with
SFAS No. 133, we designate such forward contracts as cash flow hedges. As such, the effective
portion of the gain or loss on the derivative instrument is reported as a component of other
comprehensive income and reclassified into earnings in the same period or periods during which the
hedged transaction affects earnings. Gains and losses on the derivative instruments representing
either hedge ineffectiveness or hedge components excluded from the assessment of effectiveness are
recognized in current earnings. All such forward contracts are recognized as either other assets
or accrued expenses at fair value in the statement of financial position.
The following table presents our hedging portfolio as of September 30, 2008 (in thousands).
Notional | Contract | Estimated Fair | Average | |||||||||||||||||
Amount | Value | Value | Exchange Rate | Maturity | ||||||||||||||||
2,900 |
$ | 4,118 | $ | 4,091 | 1.4199 | FY 2009 | ||||||||||||||
At September 30, 2008, $3,000 of unrealized gains were included in accumulated other comprehensive
income in the consolidated balance sheet, compared to unrealized losses of $270,000 at September
30, 2007. This amount is expected to be reclassified into net earnings during the next 12 months.
The fair value of our hedging portfolio, comprised solely of foreign exchange contracts, was an
asset of $27,000 at September 30, 2008, compared to a liability of $256,000 at September 30, 2007.
The amount of gain (loss) recognized in other comprehensive income on the effective portion of
these foreign exchange contracts was $(326,000), $(377,000), and $19,000 in fiscal 2008, 2007, and
2006, respectively. The amount of gain (loss) reclassified from accumulated other comprehensive
income into income on the effective portion of these foreign exchange contracts was $(599,000),
$(94,000), and $6,000, for fiscal 2008, 2007, and 2006, respectively. No portion of the gain/loss
was excluded from other comprehensive income due to effectiveness testing.
The estimated fair value of forward contracts outstanding at September 30, 2008, and September 30,
2007 is based on quoted amounts provided by the counterparties to these contracts.
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(5) Income Taxes
(a) Earnings before income taxes, and the related provision for income taxes for the years ended
September 30, 2008, 2007 and 2006 were as follows (dollars in thousands):
Year Ended September 30, | 2008 | 2007 | 2006 | |||||||||
Earnings before income taxes - |
||||||||||||
Domestic |
$ | 42,187 | $ | 33,324 | $ | 25,365 | ||||||
Foreign |
3,805 | 3,358 | 2,701 | |||||||||
Total |
$ | 45,992 | $ | 36,682 | $ | 28,066 | ||||||
Provision (credit) for income taxes - |
||||||||||||
Federal |
||||||||||||
Current provision |
$ | 14,307 | $ | 11,179 | $ | 8,902 | ||||||
Temporary differences |
||||||||||||
Fixed asset basis differences and depreciation |
(108 | ) | (105 | ) | (65 | ) | ||||||
Intangible asset basis differences and amortization |
(249 | ) | (249 | ) | (588 | ) | ||||||
Currently non-deductible expenses and reserves |
(286 | ) | 238 | (88 | ) | |||||||
Stock based compensation |
(610 | ) | (678 | ) | (339 | ) | ||||||
Other, net |
231 | (258 | ) | 2 | ||||||||
Tax contingency reserve adjustment |
| (2,425 | ) | | ||||||||
Subtotal |
13,285 | 7,702 | 7,824 | |||||||||
State and local |
1,303 | 1,250 | 814 | |||||||||
Foreign |
1,202 | 1,009 | 1,095 | |||||||||
Total |
$ | 15,790 | $ | 9,961 | $ | 9,733 | ||||||
(b) The following is a reconciliation between the statutory US income tax rate and the effective
rate derived by dividing the provision for income taxes by earnings before income taxes (dollars in
thousands):
Year Ended September 30, | 2008 | 2007 | 2006 | |||||||||||||||||||||
Computed income taxes at statutory rate |
$ | 16,097 | 35.0 | % | $ | 12,839 | 35.0 | % | $ | 9,824 | 35.0 | % | ||||||||||||
Increase (decrease) in taxes resulting from - |
||||||||||||||||||||||||
State and local income taxes |
902 | 2.0 | 835 | 2.3 | 685 | 2.4 | ||||||||||||||||||
Federal and state tax credits |
(34 | ) | (0.1 | ) | (213 | ) | (0.6 | ) | (88 | ) | (0.3 | ) | ||||||||||||
Foreign tax rate differences |
196 | 0.4 | 170 | 0.5 | 145 | 0.5 | ||||||||||||||||||
Valuation allowance reversal France |
| | (309 | ) | (0.8 | ) | | | ||||||||||||||||
Extra territorial income exclusion |
| | (56 | ) | (0.2 | ) | (275 | ) | (1.0 | ) | ||||||||||||||
Qualified domestic production incentives |
(715 | ) | (1.6 | ) | (290 | ) | (0.8 | ) | (236 | ) | (0.8 | ) | ||||||||||||
Tax exempt interest |
(417 | ) | (0.9 | ) | (418 | ) | (1.1 | ) | (281 | ) | (1.0 | ) | ||||||||||||
Tax contingency reserve adjustment |
| | (2,425 | ) | (6.6 | ) | | | ||||||||||||||||
Other, net |
(239 | ) | (0.5 | ) | (172 | ) | (0.5 | ) | (41 | ) | (0.1 | ) | ||||||||||||
$ | 15,790 | 34.3 | % | $ | 9,961 | 27.2 | % | $ | 9,733 | 34.7 | % | |||||||||||||
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(c) The components of net deferred tax liabilities were as follows (dollars in thousands):
As of September 30, | 2008 | 2007 | ||||||
Deferred tax assets - |
||||||||
Valuation reserves and non-deductible expenses |
$ | 951 | $ | 922 | ||||
Stock compensation expense not deductible |
1,527 | 1,237 | ||||||
Net operating loss carryforwards |
865 | 920 | ||||||
Inventory basis differences |
779 | 472 | ||||||
Other |
6 | 90 | ||||||
Subtotal |
4,128 | 3,641 | ||||||
Less valuation allowance |
(466 | ) | (569 | ) | ||||
Deferred tax assets |
3,662 | 3,072 | ||||||
Deferred tax liabilities - |
||||||||
Fixed asset basis differences and depreciation |
(639 | ) | (711 | ) | ||||
Intangible asset basis differences and amortization |
(2,680 | ) | (2,918 | ) | ||||
Other |
(488 | ) | (750 | ) | ||||
Deferred tax liabilities |
(3,807 | ) | (4,379 | ) | ||||
Net deferred tax liabilities |
$ | (145 | ) | $ | (1,307 | ) | ||
For income tax purposes, we have tax benefits related to operating loss carryforwards in the
countries of Belgium and France. These net operating loss carryforwards have no expiration date.
We have recorded deferred tax assets for these carryforwards, inclusive of valuation allowances for
the country of Belgium at September 30, 2008. These valuation allowances are for pre-acquisition
net operating loss carryforwards. If tax benefits are recognized in future years for these
pre-acquisition net operating loss carryforwards, such benefits will be allocated to reduce
goodwill and acquired intangible assets. The valuation allowance recorded against deferred tax
assets at September 30, 2007 related solely to net operating loss carryforwards in Belgium.
The realization of deferred tax assets in foreign jurisdictions is dependent upon the generation of
future taxable income in certain European countries. Management has considered the levels of
currently anticipated pre-tax income in foreign jurisdictions in assessing the required level of
the deferred tax asset valuation allowance. Taking into consideration historical and current
operating results, and other factors, management believes that it is more likely than not that the
net deferred tax asset for foreign jurisdictions, after consideration of the valuation allowance,
which has been established, will be realized. The amount of the net deferred tax asset considered
realizable in foreign jurisdictions, however, could be reduced in future years if estimates of
future taxable income during the carryforward period are reduced.
Undistributed earnings re-invested indefinitely in the Italian operation were approximately
$16,900,000 at September 30, 2008. US deferred tax liabilities of approximately $6,249,000 on such
earnings have not been
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recorded. Management believes that such US taxes would be largely offset by
foreign tax credits for taxes paid in Italy.
Effective October 1, 2007, we adopted FIN 48, which prescribes 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 cumulative effect of
adopting FIN 48, $305,000, was charged to opening retained earnings. The total amount of
unrecognized tax benefits at September 30, 2008 and October 1, 2007 was $779,000 and $856,000,
respectively, of which the full amounts would favorably affect the effective tax rate if
recognized. We recognize interest and penalties related to uncertain tax positions as a component
of our income tax provision. During fiscal 2008, we charged approximately $60,000 in interest and
penalties to our tax provision. We had approximately $147,000 for the payment of interest and
penalties accrued at September 30, 2008. 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 amount of unrecognized tax
benefits is as follows (dollars in thousands):
Unrecognized income tax benefits at October 1, 2007 |
$ | 856 | ||
Additions for tax positions related to the current year |
123 | |||
Additions for tax positions of prior years |
125 | |||
Reductions for tax positions of prior years |
(13) | |||
Settlements |
(20) | |||
Expiration of statute of limitations |
(292) | |||
Unrecognized income tax benefits at September 30, 2008 |
$ | 779 | ||
We are subject to examination by the tax authorities in the US (both federal and state) and the
countries of Belgium, France, Holland and Italy. In the US, open tax years are for fiscal 2005 and
forward, although, we completed an examination by the IRS for fiscal 2006 in February 2008. In
countries outside the US, open tax years generally range from fiscal 2003 and forward. However, in
Belgium, the utilization of local net operating loss carryforwards extends the statute of
limitations for examination well into the foreseeable future. Tax examinations in France were
completed for fiscal years 2004-2006 during fiscal 2007.
In fiscal 2000, we recorded a tax benefit related to the insolvency of a foreign subsidiary that
has since been liquidated and dissolved. At that time, a reserve was also provided for future
resolution of uncertainties related to this matter. During June 2007, the statute of limitations
expired on the tax returns affected by this matter, and consequently, the adjustment to tax
reserves resulted in a tax benefit of $2,425,000.
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(6)
Employee Benefits
(a) | Savings and Investment Plan We have a profit sharing and retirement savings plan covering substantially all full-time US 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 50% of an employees contributions, up to maximum match of 3% of eligible compensation. Our discretionary and matching contributions to the plan amounted to approximately $1,214,000, $1,132,000, and $1,066,000, during fiscal 2008, 2007 and 2006, respectively. |
(b) | Stock-Based Compensation Plans We have one active stock-based compensation plan, the 2004 Equity Compensation plan, which became effective December 7, 2004, as amended (the 2004 Plan) and an Employee Stock Purchase Plan (the ESP Plan), which became effective October 1, 1997. Effective October 1, 1997, we began selling shares of stock to our full-time and part-time employees under the ESP Plan up to the number of shares equivalent to a 1% to 15% payroll deduction from an employees base salary plus an additional 5% dollar match of this deduction by Meridian. | |
We may grant new shares for options for up to 3,000,000 shares under the 2004 Plan, of which we have granted 1,075,000 through September 30, 2008. 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 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 have granted options for 5,407,000 shares under similar plans that have expired. | ||
On November 14, 2007, we granted 252,000 options to certain employees subject to attainment of a specified earnings target for fiscal 2008. As the target was not met and the options forfeited, they have been excluded from the tables below. | ||
We adopted SFAS No. 123(R) as of July 1, 2005. SFAS No. 123(R) requires recognition of 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. We elected to adopt the provisions of SFAS No. 123(R), pursuant to the modified prospective method, which requires compensation expense be measured and recognized based on grant-date fair value for stock option awards granted after July 1, 2005 and the non-vested portions of stock option awards granted prior to July 1, 2005. | ||
The amount of stock-based compensation expense reported was $1,772,000, $2,632,000 and $1,082,000 in fiscal 2008, fiscal 2007, and fiscal 2006, respectively. The total income tax benefit recognized in the income statement for these stock-based compensation arrangements was $610,000, $678,000, and $339,000, |
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for fiscal 2008, fiscal 2007, and fiscal 2006, respectively. We expect future stock compensation expense for unvested options as of September 30, 2008 to be $1,547,000, which will be recognized during fiscal years 2009 through 2013. |
SFAS No. 123(R) requires that we recognize compensation expense only for the portion of shares that we expect to vest. As such, we apply estimated forfeiture rates to our compensation expense calculations. These rates have been derived using historical forfeiture data, stratified by several employee groups. During fiscal 2008 and fiscal 2007, we recorded $235,000 and $210,000, respectively, in stock 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, with the following assumptions: (i) expected share price volatility based on implied volatility calculations using options for Meridian and a peer-group of companies; (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. |
Year Ended September 30, | 2008 | 2007 | 2006 | |||||||||
Risk-free interest rates |
4.56 | % | 4.64 | % | 4.3%-4.4 | % | ||||||
Dividend yield |
1.45 | % | 1.96 | % | 1.55 | % | ||||||
Life of option |
5.70-7.30 yrs. | 5.80-7.50 yrs. | 5.70-7.50 yrs. | |||||||||
Share price volatility |
44 | % | 44 | % | 46 | % | ||||||
Forfeitures (by employee group) |
0%-17 | % | 0%-20 | % | 0%-20 | % | ||||||
A summary of the status of our stock option plans at September 30, 2008 and changes during the
year is presented in the table and narrative below:
Wtd Avg | Wtd Avg | |||||||||||||||
Exercise | Remaining | Aggregate | ||||||||||||||
Shares | Price | Life (Yrs) | Intrinsic Value | |||||||||||||
Outstanding
beginning of period |
1,931,884 | $ | 7.79 | |||||||||||||
Grants |
100,950 | 33.22 | ||||||||||||||
Exercises |
(468,559 | ) | 5.84 | |||||||||||||
Forfeitures |
(13,714 | ) | 16.25 | |||||||||||||
Cancellations |
(2,547 | ) | 16.68 | |||||||||||||
Outstanding end of period |
1,548,014 | $ | 9.95 | 5.6 | $ | 29,978,000 | ||||||||||
Exercisable end of period |
528,952 | $ | 7.72 | 5.2 | $ | 11,355,000 | ||||||||||
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A summary of the status of our nonvested shares as of September 30, 2008, and changes during the year ended September 30, 2008, is presented below: |
Weighted- | ||||||||
Average Grant | ||||||||
Date Fair | ||||||||
Shares | Value | |||||||
Nonvested beginning of period |
1,284,364 | $ | 4.03 | |||||
Granted |
100,950 | 14.58 | ||||||
Vested |
(352,538 | ) | 4.75 | |||||
Forfeited |
(13,714 | ) | 7.11 | |||||
Nonvested end of period |
1,019,062 | $ | 4.79 | |||||
The weighted average grant-date fair value of options granted was $14.58, $7.10, and $6.54 for fiscal 2008, 2007, and 2006, respectively. The total intrinsic value of options exercised was $11,405,000, $5,526,000 and $2,648,000, for fiscal 2008, 2007, and 2006, respectively. The total grant-date fair value of options that vested during fiscal 2008, 2007, and 2006 was $1,674,000, $721,000 and $296,000, respectively. | ||
Cash received from options exercised was $2,668,000, $1,318,000, and $990,000 for fiscal 2008, 2007, and 2006, respectively. Tax benefits realized and recorded to additional paid-in capital from option exercises totaled $2,458,000, $1,632,000, and $732,000 for fiscal 2008, 2007, and 2006 respectively. |
(7) Major Customers and Segment Data
Meridian was formed in 1976 and functions as a fully integrated research, development,
manufacturing, marketing and sales organization with primary emphasis in the field of life science.
Our principal businesses are (i) the development, manufacture and distribution of diagnostic test
kits primarily for certain respiratory, gastrointestinal, viral and parasitic infectious diseases,
(ii) the manufacture and distribution of bulk antigens, antibodies, and reagents used by
researchers and other diagnostic manufacturers and (iii) the contract manufacture of proteins and
other biologicals under clinical cGMP conditions for use by biopharmaceutical and biotechnology
companies engaged in research for new drugs and vaccines.
Our reportable operating segments are US Diagnostics, European Diagnostics, and Life Science. The
US Diagnostics operating segment consists of manufacturing operations in Cincinnati, Ohio, and the
sale and distribution of diagnostic test kits in the US and countries outside of Europe, Africa and
the Middle East. The European Diagnostics operating segment consists of the sale and distribution
of diagnostic test kits in Europe, Africa, and the Middle East. The Life Science operating segment
consists of manufacturing operations in Memphis, Tennessee, Saco, Maine, and Boca Raton, Florida,
and the sale and distribution of bulk antigens, antibodies and bioresearch reagents domestically
and abroad. The Life Science operating segment also includes
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the contract development and
manufacture of cGMP clinical grade proteins and other biologicals for use by biopharmaceutical and
biotechnology companies engaged in research for new drugs and vaccines.
Sales to individual customers constituting 10% or more of consolidated net sales were as follows
(dollars in thousands):
Year Ended September 30, | 2008 | 2007 | 2006 | |||||||||||||||||||||
Customer A (US Diagnostics) |
$ | 31,285 | (22 | %) | $ | 24,444 | (20 | %) | $ | 19,543 | (18 | %) | ||||||||||||
Customer B (US Diagnostics) |
$ | 16,160 | (12 | %) | $ | 13,340 | (11 | %) | $ | 10,989 | (10 | %) | ||||||||||||
Combined export sales for the US Diagnostics and Life Science operating segments were $16,450,000,
$15,128,000 and $14,729,000 in fiscal years 2008, 2007 and 2006, respectively. Three products
accounted for 32%, 31%, and 28% of consolidated net sales in fiscal 2008, fiscal 2007, and fiscal
2006, respectively. Approximately 25% of the consolidated accounts receivable balance at September
30, 2008 is largely dependent upon funds from the Italian government.
Significant country information for the European Diagnostics operating segment is as follows
(dollars in thousands). Sales are attributed to the geographic area based on the location to which
the product is shipped.
Year Ended September 30, | 2008 | 2007 | 2006 | |||||||||
Italy |
$ | 8,942 | $ | 7,838 | $ | 6,840 | ||||||
France |
3,263 | 3,070 | 2,387 | |||||||||
United Kingdom |
2,655 | 1,987 | 1,571 | |||||||||
Holland |
2,138 | 1,610 | 1,372 | |||||||||
Belgium |
1,865 | 1,558 | 1,504 | |||||||||
Other countries |
9,117 | 7,500 | 6,154 | |||||||||
Total European Operating Segment |
$ | 27,980 | $ | 23,563 | $ | 19,828 | ||||||
Identifiable assets for our Italian distribution organization were $14,769,000, $12,811,000, and
$11,397,000 at September 30, 2008, 2007 and 2006, respectively.
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Segment information for the years ended September 30, 2008, 2007, and 2006 is as follows (dollars
in thousands):
US | European | Life | ||||||||||||||||||
Diagnostics | Diagnostics | Science | Elim (1) | Total | ||||||||||||||||
Fiscal Year 2008 - |
||||||||||||||||||||
Net sales |
||||||||||||||||||||
Third-party |
$ | 88,419 | $ | 27,980 | $ | 23,240 | $ | 139,639 | ||||||||||||
Inter-segment |
11,563 | 2 | 543 | $ | (12,108 | ) | | |||||||||||||
Operating income |
36,095 | 5,397 | 3,186 | (328 | ) | 44,350 | ||||||||||||||
Depreciation and amortization |
2,745 | 111 | 1,614 | | 4,470 | |||||||||||||||
Capital expenditures |
2,193 | 39 | 1,987 | | 4,219 | |||||||||||||||
Total assets |
126,808 | 15,955 | 49,619 | (45,951 | ) | 146,431 | ||||||||||||||
Fiscal Year 2007 - |
||||||||||||||||||||
Net sales |
||||||||||||||||||||
Third-party |
$ | 74,845 | $ | 23,563 | $ | 24,555 | $ | 122,963 | ||||||||||||
Inter-segment |
8,872 | | 532 | $ | (9,404 | ) | | |||||||||||||
Operating income |
26,454 | 4,930 | 3,795 | (149 | ) | 35,030 | ||||||||||||||
Depreciation and amortization |
2,641 | 110 | 1,648 | | 4,399 | |||||||||||||||
Capital expenditures |
1,645 | 52 | 1,514 | | 3,211 | |||||||||||||||
Total assets |
115,297 | 13,600 | 45,410 | (41,609 | ) | 132,698 | ||||||||||||||
Fiscal Year 2006 - |
||||||||||||||||||||
Net sales |
||||||||||||||||||||
Third-party |
$ | 65,721 | $ | 19,828 | $ | 22,864 | $ | 108,413 | ||||||||||||
Inter-segment |
7,171 | | 712 | $ | (7,883 | ) | | |||||||||||||
Operating income |
19,881 | 3,828 | 3,144 | 41 | 26,894 | |||||||||||||||
Depreciation and amortization |
2,586 | 129 | 2,574 | | 5,289 | |||||||||||||||
Capital expenditures |
2,040 | 37 | 1,043 | | 3,120 | |||||||||||||||
Total assets |
109,678 | 12,716 | 41,751 | (43,617 | ) | 120,528 | ||||||||||||||
(1) | Eliminations consist of intersegment transactions. |
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Year Ended September 30, | 2008 | 2007 | 2006 | |||||||||
Segment operating income |
$ | 44,350 | $ | 35,030 | $ | 26,894 | ||||||
Interest income |
1,533 | 1,642 | 1,123 | |||||||||
Interest expense |
| (38 | ) | (128 | ) | |||||||
Other, net |
109 | 48 | 177 | |||||||||
Consolidated earnings before income taxes |
$ | 45,992 | $ | 36,682 | $ | 28,066 | ||||||
The accounting policies of the segments are the same as those described in the summary of
significant accounting policies in Note 1. Transactions between operating segments are accounted
for at established intercompany prices for internal and management purposes with all intercompany
amounts eliminated in consolidation. Total assets for the US Diagnostics and Life Science
operating segments include goodwill of $1,382,000 and $8,479,000, respectively at September 30,
2008, $1,492,000 and $8,472,000, respectively at September 30, 2007, and $1,578,000 and $8,286,000,
respectively at September 30, 2006.
(8) Commitments and Contingencies
(a) | Royalty Commitments We have entered into various license agreements that require payment of royalties based on a specified percentage of the sales of licensed products (1% to 8%). These royalty expenses are recognized on an as-earned basis and recorded in the year earned as a component of cost of sales. Annual royalty expenses associated with these agreements were approximately $600,000, $739,000, and $866,000, respectively, for the fiscal years ended September 30, 2008, 2007 and 2006. | |
During October 2006, we entered into a license agreement with Eiken Chemical Co., Ltd., that provides rights to Eikens loop-mediated isothermal amplification technology for infectious disease testing in the United States and 18 other geographic markets. The agreement calls for payments of up to 200,000,000 Japanese Yen (approximately $1,889,000 as of September 30, 2008) based on the achievement of certain milestones and on-going royalties once products are available for commercial sale. Payments made during product development are expected to occur over a five-year period and began in fiscal 2007 with a payment equal to 20,000,000 Japanese Yen or $169,000. | ||
During the fourth quarter of fiscal 2007, we began seeking recovery of approximately $1,400,000 of past royalties paid and interest under a license agreement around certain rapid diagnostic testing technology. This license agreement covered patent rights that were narrowed in scope via other litigation with the licensor that did not involve Meridian. We strongly believe that the licensed patent, as reissued, does not cover any of our products. We also ceased further royalty payments under this license agreement. The licensor to this agreement disputes our position that the patent, as reissued, does not cover our products. Although we believe that our position is very strong, we are unable to predict the outcome of this matter. |
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No provision has been made in the accompanying financial statements for on-going royalties, if any, nor has any accrual or income been recorded for recovery of past royalties paid. | ||
(b) | Purchase Commitments We have purchase commitments primarily for inventory and service items as part of the normal course of business. Commitments made under these obligations are $12,793,000, $187,000, and $199,000 for fiscal 2009, 2010, and 2011, respectively. No commitments have been made beyond fiscal 2011. | |
(c) | Operating Lease Commitments Meridian and its subsidiaries are lessees of (i) office and warehouse buildings in Florida, Belgium, and France; (ii) automobiles for use by the direct sales forces in the US and Europe; and (iii) certain office equipment such as facsimile machines and copier machines across all business units, under operating lease agreements that expire at various dates. Amounts charged to expense under operating leases were $674,000, $696,000 and $686,000 for fiscal 2008, 2007 and 2006, respectively. Operating lease commitments for each of the five succeeding fiscal years are as follows: fiscal 2009 - $602,000, fiscal 2010 $453,000, fiscal 2011 $290,000, fiscal 2012 $196,000, and fiscal 2013 $154,000. | |
(d) | Litigation We are a party to litigation that we believe is in the normal course of business. The ultimate resolution of these matters is not expected to have a material adverse effect on our financial position, results of operations or cash flows. No provision has been made in the accompanying consolidated financial statements for these matters. | |
(e) | Indemnifications In conjunction with certain contracts and agreements, we provide routine indemnifications whose terms 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, cannot be reasonably estimated. We have not made any payments for these indemnifications and no liability is recorded at September 30, 2008 or September 30, 2007. We believe that if we were to incur a loss on any of these matters, the loss would not have a material effect on our financial condition. | |
(f) | Viral Antigens Earnout | |
The purchase agreement for the Viral Antigens purchase acquisition provided for additional consideration, contingent upon Viral Antigens earnings through September 30, 2006. Final earnout consideration in the amount of $853,000 for fiscal 2006 was paid during the second quarter of fiscal 2007. This amount is included in goodwill in the accompanying consolidated balance sheets. |
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(g) | OEM Concepts Earnout | |
The purchase agreement for the OEM Concepts acquisition provides for additional consideration, up to a maximum remaining amount of $1,814,000 at September 30, 2008, contingent upon future calendar year sales and gross profit of OEM Concepts products through December 31, 2008. Earnout consideration in the amount of $275,000 has been paid to date for calendar 2006 and 2007. Earnout consideration in the amount of $3,000 has been accrued in the accompanying consolidated balance sheet for calendar 2008 to date. Future earnout consideration, if any, will be allocated to goodwill, and will be recorded in the period in which it is earned and payable. |
(9) Quarterly Financial Data (Unaudited)
All quarters of fiscal 2007 have been adjusted to reflect the July 1, 2007 change in accounting for certain inventories within the Life Science operating segment from the LIFO method to the FIFO method. | ||
Amounts are in thousands except per share data. The sum of the earnings per common share and cash dividends per share may not equal the corresponding annual amounts due to interim quarter rounding. |
For the Quarter Ended in Fiscal 2008 | December 31 | March 31 | June 30 | September 30 | ||||||||||||
Net sales |
$ | 33,847 | $ | 36,249 | $ | 33,068 | $ | 36,475 | ||||||||
Gross profit |
21,752 | 21,115 | 21,287 | 22,326 | ||||||||||||
Net earnings |
7,456 | 7,299 | 7,763 | 7,684 | ||||||||||||
Basic earnings per common share |
0.19 | 0.18 | 0.19 | 0.19 | ||||||||||||
Diluted earnings per common share |
0.18 | 0.18 | 0.19 | 0.19 | ||||||||||||
Cash dividends per common share |
0.11 | 0.14 | 0.14 | 0.14 | ||||||||||||
For the Quarter Ended in Fiscal 2007 | December 31 | March 31 | June 30 | September 30 | ||||||||||||
Net sales |
$ | 28,720 | $ | 32,094 | $ | 29,763 | $ | 32,386 | ||||||||
Gross profit |
17,612 | 18,838 | 19,301 | 19,189 | ||||||||||||
Net earnings |
5,573 | 5,890 | 8,814 | 6,444 | ||||||||||||
Basic earnings per common share |
0.14 | 0.15 | 0.22 | 0.16 | ||||||||||||
Diluted earnings per common share |
0.14 | 0.15 | 0.22 | 0.16 | ||||||||||||
Cash dividends per common share |
0.08 | 0.11 | 0.11 | 0.11 |
(10) Stock Split
On April 19, 2007, we announced a three-for-two stock split, with fractional shares paid in cash. This split was effective on May 11, 2007, for shareholders of record on May 4, 2007. All references in this Annual Report on Form 10-K to number of shares and per share amounts reflect this stock split. |
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ITEM 9.
CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS
ON ACCOUNTING AND FINANCIAL DISCLOSURE
ON ACCOUNTING AND FINANCIAL DISCLOSURE
Not applicable.
ITEM 9A.
CONTROLS AND PROCEDURES
As of September 30, 2008, 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.
Based on that evaluation, our management, including the CEO and CFO, concluded that our disclosure
controls and procedures were effective as of September 30, 2008. 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, 2008.
Our internal control report is included in this Annual Report on Form 10-K after Item 8, under the
caption Managements Report on Internal Control over Financial Reporting.
ITEM 9B.
OTHER INFORMATION
Not applicable.
PART III
The information required by Items 10., 11., 13., and 14., of Part III are incorporated by reference
from the Registrants Proxy Statement for its 2009 Annual Shareholders Meeting to be filed with
the Commission pursuant to Regulation 14A.
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ITEM 12.
EQUITY
COMPENSATION PLAN INFORMATION
The following table presents summary information as of September 30, 2008 with respect to all of
our equity compensation plans.
(c) | ||||||||||||
Number of securities | ||||||||||||
(a) | remaining available | |||||||||||
Number of | (b) | for future issuance | ||||||||||
Securities to be | Weighted- | under equity | ||||||||||
issued upon | average exercise | compensation plans | ||||||||||
exercise of | price of | (excluding | ||||||||||
outstanding | outstanding | securities | ||||||||||
options, warrants | options, warrants | reflected in column | ||||||||||
Plan Category | and rights | and rights | (a)) | |||||||||
Equity compensation
plans approved by
security
holders(1) |
1,502,164 | $ | 9.861 | 1,985,609 | ||||||||
Equity compensation
plans not approved by
security holders |
45,850 | 12.810 | | |||||||||
Total |
1,548,014 | $ | 9.949 | 1,985,609 | ||||||||
(1) | 1994 Directors Stock Option Plan | |
1996 Stock Option Plan, as amended in 2001 | ||
1999 Directors Stock Option Plan | ||
2004 Equity Compensation Plan, as amended |
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 listed previously 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
|
Articles of Incorporation, including amendments not related to Company name change (Incorporated by reference to Registration Statement No. 333-02613 on Form S-3 filed with the Securities and Exchange Commission on April 18, 1996 and Meridians Form 8-K filed with the Securities and Exchange Commission on May 16, 2007) | |
3.2
|
Code of Regulations (Incorporated by reference to Meridians Form 8-K filed with the Securities and Exchange Commission on July 23, 2008) | |
10.5
|
Sublicense Agreement dated June 17, 1993 among Johnson & Johnson, the Scripps Research Institute and Meridian Concerning certain Patent Rights (Incorporated by reference to Meridians Form 8-K filed with the Securities and Exchange Commission on June 17, 1993) | |
10.6
|
Assignment dated June 17, 1993 from Ortho Diagnostic Systems Inc. to Meridian |
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Exhibit Number | Description of Exhibit | |
concerning certain Patent Rights (Incorporated by reference to Meridians Form 8-K filed with the Securities and Exchange Commission on June 17, 1993) | ||
10.9
|
Merger Agreement among Gull Laboratories, Inc., Meridian Diagnostics, Inc. Fresenius AG and Meridian Acquisition Co. dated as of September 15, 1998 (Incorporated by reference to Meridians Form 8-K filed with the Securities and Exchange Commission on September 17, 1998) | |
10.10*
|
Savings and Investment Plan Prototype Adoption Agreement (Incorporated by reference to Meridians Annual Report on Form 10-K for the Fiscal Year Ended September 30, 2003) | |
10.14*
|
1994 Directors Stock Option Plan (Incorporated by reference to Registration Statement No. 33-78868 on Form S-8 filed with the Securities and Exchange Commission on May 12, 1994) | |
10.15*
|
1996 Stock Option Plan (Incorporated by reference to Meridians Annual Report on Form 10-K for the Fiscal Year Ended September 30, 1996) | |
10.16*
|
Salary Continuation Agreement for John A. Kraeutler (Incorporated by reference to Meridians Annual Report on Form 10-K for the Fiscal Year Ended September 30, 1995) | |
10.17
|
Merger Agreement Among Gull Laboratories, Inc., Meridian Diagnostics, Inc. Fresenius AG and Meridian Acquisition Co. dated as of September 15, 1998, as amended on October 22, 1998 (Incorporated by reference to Meridians Report on Form 8-K filed with the Securities and Exchange Commission on September 17, 1998 and Meridians Report on Form 8-K filed with the Securities and Exchange Commission on November 13, 1998) | |
10.18*
|
1999 Directors Stock Option Plan (Incorporated by reference to Meridians Proxy Statement filed with the Securities and Exchange Commission on December 21, 1998) | |
10.20
|
Dividend Reinvestment Plan (Incorporated by reference to Meridians Annual Report on Form 10-K for the Fiscal Year Ended September 30, 1999) | |
10.21
|
Merger Agreement dated September 13, 2000 among Meridian and the Shareholders of Viral Antigens, Inc. (Incorporated by reference to Meridians Form 8-K filed with the Securities and Exchange Commission on September 29, 2000) | |
10.23*
|
Employment Agreement Dated February 15, 2001 between Meridian and John A. Kraeutler, including the Addendum to Employment Agreement dated April 24, 2001 between Meridian and John A. Kraeutler (Incorporated by reference to Meridians Annual Report on Form 10-K for the Fiscal Year Ended September 30, 2001) | |
10.24*
|
Sample Option Agreement Dated October 1, 2001 (Incorporated by reference to Meridians Annual Report on Form 10-K for the Fiscal Year Ended September 30, 2001) | |
10.26*
|
1996 Stock Option Plan as Amended and Restated Effective January 23, 2001 (Incorporated by reference to Meridians Proxy Statement filed with the Securities and Exchange Commission on December 21, 1998) | |
10.27*
|
Sample Option Agreement Dated November 19, 2002 (Incorporated by reference to Meridians Annual Report on Form 10-K for the Fiscal Year Ended September 30, 2003) | |
10.28*
|
Agreement Concerning Disability and Death dated September 10, 2003, between Meridian and William J. Motto (Incorporated by reference to Meridians Annual Report on Form 10-K for the Fiscal Year Ended September 30, 2003) |
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Exhibit Number | Description of Exhibit | |
10.29*
|
Professional Services Agreement dated October 1, 2002 between Meridian and Antonio Interno (Incorporated by reference to Meridians Annual Report on Form 10-K for the Fiscal Year Ended September 30, 2003) | |
10.31
|
Stock Purchase Agreement of OEM Concepts, Inc. by Meridian Bioscience, Inc. dated January 31, 2005 (Incorporated by reference to Meridians Annual Report on Form 10-K for the Fiscal Year Ended September 30, 2005) | |
10.32*
|
Sample Option Agreement dated November 10, 2005 (Incorporated by reference to Meridians Annual Report on Form 10-K for the Fiscal Year Ended September 30, 2005) | |
10.33*
|
2004 Equity Compensation Plan, Amended and Restated through January 22, 2008 (Incorporated by reference to Meridians Proxy Statement filed with the Securities and Exchange Commission on December 19, 2007) | |
10.34*
|
Fiscal 2006 Officers Compensation Plan, Amended and Restated through January 19, 2006 (Incorporated by reference to Meridians Form 8-K filed with the Securities and Exchange Commission on January 19, 2006) | |
10.35*
|
Sample Option Agreement dated November 14, 2007 (Incorporated by reference to Meridians Annual Report on Form 10-K for the Fiscal Year Ended September 30, 2007) | |
10.36*
|
Fiscal 2007 Officers Performance Compensation Plan (Incorporated by reference to Meridians Form 8-K filed with the Securities and Exchange Commission on November 21, 2006) | |
10.37
|
Loan and Security Agreement among Meridian Bioscience, Inc., Meridian Bioscience Corporation, Omega Technologies, Inc. Meridian Life Science, Inc. and Fifth Third Bank dated August 1, 2007 (Incorporated by reference to Meridians Annual Report on Form 10-K for the Fiscal Year Ended September 30, 2007) | |
10.37.1
|
Amended and Restated Revolving Note with Fifth Third Bank dated August 1, (Incorporated by reference to Meridians Annual Report on Form 10-K for the Fiscal Year Ended September 30, 2007) | |
10.38*
|
Sample Restricted Stock Agreement dated November 12, 2008 (Filed herewith) | |
13
|
2008 Annual Report to Shareholders (1) | |
14
|
Code of Ethics (Incorporated by reference to Meridians Annual Report on Form 10-K for the Fiscal Year Ended September 30, 2003) | |
18
|
Grant Thornton Preferability Letter (Incorporated by reference to Meridians Annual Report on Form 10-K for the Fiscal Year Ended September 30, 2007) | |
21
|
Subsidiaries of the Registrant (Filed herewith) | |
23
|
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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Exhibit Number | Description of Exhibit | |
32
|
Section 1350 Certification of Chief Executive Officer and Chief Financial Officer (Filed herewith) |
(1) | Only portions of the 2008 Annual Report to Shareholders specifically are incorporated by reference in this Form 10-K as filed herewith. A supplemental paper copy of the 2008 Annual Report to Shareholders has been provided to the Securities and Exchange Commission for informational purposes only. | |
* | Management Compensatory Contracts |
Meridian will provide shareholders with any exhibit upon the payment of a specified reasonable fee,
which fee shall be limited to Meridians reasonable expenses in furnishing such exhibit.
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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/ John A. Kraeutler | |||
Date: November 26, 2008 | John A. Kraeutler | |||
Chief Executive Officer |
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Table of Contents
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/ William J. Motto
|
Chairman of the Board of Directors | November 26, 2008 | ||
/s/ John A. Kraeutler
|
Chief Executive Officer, Director | November 26, 2008 | ||
/s/ Melissa Lueke
|
Vice President and Chief Financial Officer | November 26, 2008 | ||
/s/ James A. Buzard
|
Director | November 26, 2008 | ||
/s/ Gary P. Kreider
|
Director | November 26, 2008 | ||
/s/ David C. Phillips
|
Director | November 26, 2008 | ||
/s/ Robert J. Ready
|
Director | November 26, 2008 |
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SCHEDULE II
Meridian Bioscience, Inc.
and Subsidiaries
Meridian Bioscience, Inc.
and Subsidiaries
Valuation and Qualifying Accounts
(Dollars in thousands)
Years Ended September 30, 2008, 2007 and 2006
(Dollars in thousands)
Years Ended September 30, 2008, 2007 and 2006
Charged | ||||||||||||||||||||
Balance at | to Costs | Balance | ||||||||||||||||||
Beginning | and | at End of | ||||||||||||||||||
Description | of Period | Expenses | Deductions | Other (a) | Period | |||||||||||||||
Year Ended September 30, 2008: |
||||||||||||||||||||
Allowance for doubtful accounts |
$ | 258 | $ | 38 | $ | (70 | ) | $ | 4 | $ | 230 | |||||||||
Inventory realizability reserves |
1,162 | 551 | (610 | ) | | 1,103 | ||||||||||||||
Valuation allowances deferred taxes |
569 | | (115 | ) | 12 | 466 | ||||||||||||||
Year Ended September 30, 2007: |
||||||||||||||||||||
Allowance for doubtful accounts |
$ | 408 | $ | 19 | $ | (200 | ) | $ | 31 | $ | 258 | |||||||||
Inventory realizability reserves |
1,158 | 259 | (258 | ) | 3 | 1,162 | ||||||||||||||
Valuation allowances deferred taxes |
888 | | (390 | ) | 71 | 569 | ||||||||||||||
Year Ended September 30, 2006: |
||||||||||||||||||||
Allowance for doubtful accounts |
$ | 360 | $ | 132 | $ | (102 | ) | $ | 18 | $ | 408 | |||||||||
Inventory realizability reserves |
556 | 822 | (221 | ) | 1 | 1,158 | ||||||||||||||
Valuation allowances deferred taxes |
927 | | (32 | ) | (7 | ) | 888 |
(a) | Balances reflect the effects of currency translation. |
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