MERIDIAN BIOSCIENCE INC - Annual Report: 2007 (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, 2007.
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.
Incorporated under the Laws of Ohio Phone: (513) 271-3700 |
3471 River Hills Drive Cincinnati, Ohio 45244 |
IRS Employer ID No. 31-0888197 |
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 o NO þ
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 þ NO o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated
filer, or a non-accelerated filer. See definition of accelerated filer and large
accelerated filer in Rule 12b-2 of the Exchange Act.
Large accelerated filer o Accelerated filer þ Non-accelerated filer 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, 2007
was $699,747,338 based on a closing sale price of $18.51 per share on March 30, 2007. As
of October 31, 2007, 39,877,672 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, 2007 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 2008 Annual
Shareholders Meeting are incorporated by reference in Part III as specified.
MERIDIAN BIOSCIENCE, INC.
INDEX TO ANNUAL REPORT
ON FORM 10-K
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Item 10 Directors and Executive Officers of the Registrant |
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Item 11 Executive Compensation |
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Item 13 Certain Relationships and Related Transactions |
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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 report contains forward-looking statements 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. 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.
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 9 to the consolidated financial
statements contained herein.
Our primary source of domestic and international revenues continues to be core diagnostic products,
which represented 80% of consolidated net sales for fiscal 2007. 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.
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 $74,845,000, $65,721,000 and
$53,485,000 for fiscal 2007, 2006 and 2005, respectively, reflecting a three-year compound annual
growth rate of 16%. As of September 30, 2007, our US Diagnostics operating segment had 250
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 independent distributors in the US and abroad. The direct sales force consists
of one senior director of sales, three regional sales managers, one director of corporate health
systems, one manager of corporate health systems, one director of health plan and payer markets,
one international distribution manager, 25 technical sales representatives, and three inside sales
representatives. We utilize two primary independent distributors in the US, who accounted for 51%
of the US Diagnostics operating segments third-party sales in fiscal 2007. 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
140 medical diagnostic products. Our products generally range in list price from $1 per test to
$33 per test.
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 2007, 2006 and 2005 were $4,571,000, $3,342,000 and $3,043,000, 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 39% of our US Diagnostics
operating segments third-party sales during fiscal 2007.
We 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.
Over the last 15 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
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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.
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. Meridian produces substantially all of its 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 25 products manufactured by our US
Diagnostics operating segment, including Premierä Platinum HpSA and Premierä Platinum
HpSA Plus. 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 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.
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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 70% of third-party sales for fiscal 2007 for this operating segment were
products purchased from our US Diagnostics operating segment. Third-party sales for this operating
segment were $23,563,000, $19,828,000 and $17,818,000 for fiscal 2007, 2006 and 2005, respectively,
reflecting a three-year compound annual growth rate of 15%. As of September 30, 2007, the European
Diagnostics operating segment had 40 employees, including 17 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 $24,555,000, $22,864,000 and
$21,662,000 for fiscal 2007, 2006 and 2005, respectively, reflecting a three-year compound annual
growth rate of 15%. As of September 30, 2007, our Life Science operating segment had 106
employees.
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 2007, 27% 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.
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.
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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(j) to the Consolidated Financial Statements
herein for revenue recognition policies. Our revenues for contract services were $765,000,
$2,537,000, and $3,053,000 in fiscal 2007, 2006, and 2005, respectively.
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. Over the last 18 months,
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 |
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) having a sales value of up to
$12,200,000 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.
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Research and Development
Our Life Science operating segments research and development organization consists of 5 research
scientists. Research and development expenses for our Life Science operating segment for fiscal
2007, 2006 and 2005 were $1,514,000, $1,457,000 and $823,000, respectively. This research and
development organization has integrated its activities around the four product brands previously
discussed.
Manufacturing and Government Regulation
The cGMP clinical grade proteins that are produced in our Memphis facility are intended to be used
as injectables. 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.
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 of 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 Abbott
Laboratories Inc., Becton, Dickinson and Company, Diagnostic Products Corporation (acquired by
Siemens in 2006), Quidel Corporation, Inverness Medical, and Remel (owned by Thermo Fisher).
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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 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 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 $38,691,000
or 31% of total fiscal 2007 sales, $34,557,000 or 32% of total fiscal 2006 sales and $30,232,000 or
33% of total fiscal 2005 sales. Domestic exports for our US Diagnostics and Life Science operating
segments were $15,128,000, $14,728,000 and $12,414,000 in fiscal 2007, 2006 and 2005, 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. All hazardous material is manifested and disposed of properly. 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.
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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. 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 2007, 2006, and 2005, we incurred $6,085,000, $4,799,000, and $3,866,000, 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
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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 51% and 47%,
respectively, of the US Diagnostics operating segments total sales for fiscal 2007 and fiscal
2006, or 31% and 29%, respectively, of consolidated total sales for fiscal 2007 and fiscal 2006.
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.
Seasonal Factors and Sporadic Outbreaks
Our principal business is the sale of a broad range of diagnostic test kits for common 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 food-borne
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
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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
27% and 18%, respectively, of the Life Science operating segments total sales for fiscal 2007 and
fiscal 2006, or 5% and 4%, respectively, of our consolidated total sales for fiscal 2007 and fiscal
2006. 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 five other significant customers who purchase antigens,
antibodies and reagents, which together comprised 19% and 20%, respectively, of the operating
segments total sales for fiscal 2007 and fiscal 2006. 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.
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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 31% of our net sales
for fiscal 2007 and approximately 32% of our net sales for fiscal 2006 were attributable to
international markets. For fiscal 2007, 52% of our international sales were made in Euros, with the
remaining 48% made in U.S. dollars. We are subject to the risks associated with fluctuations in
the U.S. 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 U.S. Food and Drug
Administration, the U.S. Department of Agriculture, the U.S. Department of Commerce, the U.S. Drug
Enforcement Agency, or the Centers for Disease Control can result in 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 U.S. 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 comprise 81% of our diagnostics revenues and 78% 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, or terrorist
threats.
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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.
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 a third partys 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.
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If product liability lawsuits are successfully brought against us, we may incur substantial
liabilities and may have to limit or cease sales of our products.
The testing, manufacturing, and marketing of medical diagnostic products involves an inherent risk
of product liability claims. If we cannot successfully defend ourselves against product liability
claims, we may incur substantial liabilities or be required to limit or cease sales of our
products. We currently carry product liability insurance at a level we believe is commercially
reasonable, although there is no assurance that it will be adequate to cover claims that may arise.
In certain customer contracts, we indemnify third parties for certain product liability claims
related to our products. These indemnification obligations may cause us to pay significant sums of
money for claims that are covered by these indemnifications. In addition, a defect in the design
or manufacture of our products could have a material adverse affect on our reputation in the
industry and subject us to claims of liability for injury and otherwise. Any substantial
underinsured loss resulting from such a claim could have a material adverse 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.
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
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adversely affect the market price of our common stock and our ability to raise additional capital
at a price favorable to us.
ITEM 1B.
UNRESOLVED SEC STAFF COMMENTS
None.
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 10,000
square feet for manufacturing, sales, distribution and administrative functions, and is owned by
us. We have recently begun an expansion that will add approximately 14,000 square feet to
accommodate future growth. 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.
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ITEM 4.
SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
No matters were submitted to a vote of security holders during the fourth quarter of fiscal 2007.
PART II.
ITEM 5.
MARKET FOR REGISTRANTS COMMON
EQUITY AND RELATED STOCKHOLDER MATTERS
EQUITY AND RELATED STOCKHOLDER MATTERS
Common Stock Information on the inside back cover of the Annual Report to Shareholders for 2007
and Quarterly Financial Data relating to our dividends in Note 11 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 $0.40 per share, $0.28 per share, and $0.21 per share in fiscal 2007, fiscal
2006, and fiscal 2005, respectively.
On May 11, 2007, we affected a three-for-two stock split for shareholders of record on May 4, 2007.
On September 2, 2005, we affected a three-for-two stock split to shareholders of record on August
29, 2005. All references in this Annual Report to number of shares and per share amounts reflect
the effects of these stock splits.
As of September 30, 2007, Meridian believes there were approximately 900 holders of record and
approximately 27,000 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 2007.
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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 12 through 19 of this Annual Report.
Overview:
For fiscal 2007, we delivered our fifth consecutive year of double-digit sales and earnings growth.
Our diagnostics operating segments continue to provide the largest share of consolidated revenues,
80%, for fiscal 2007 compared to 79% for fiscal 2006. Our Life Science operating segments sales
performance improved quarter-by-quarter throughout fiscal 2007, with double-digit increases in the
third and fourth quarters. We are encouraged by this momentum as we enter fiscal 2008.
Our sales growth in fiscal 2007 was organic and driven by new diagnostic products launched in the
past three years, market expansions, increased market share in targeted disease states, and volume
increases for antibodies, antigens and reagents supplied to large diagnostic manufacturing
companies. Our newest diagnostic product contributing to growth is ImmunoCard STAT!®
EHEC, a rapid test developed in collaboration with Merck for detection of toxin-producing E. coli
in patients that may have ingested contaminated produce or meat products. We continue to see
growth in the C. difficile testing market where we hold a market leadership position. This market
has expanded as testing increases due to more virulent strains of this toxin and heightened focus
by hospitals on this dangerous pathogen. We have been well positioned with our broad line of C.
difficile products, including our newest in the portfolio, ImmunoCard® Toxins A&B. Our
upper respiratory line of products also saw growth, as did our H. pylori line of products. New AGA
guidelines are creating increased focus on direct antigen testing for this infection that causes
ulcers. Our line of patented H. pylori products includes both rapid and batch method
noninvasive direct testing formats. We are seeing growth as more laboratories switch from serology
based antibody testing to direct antigen testing. Finally, our Life Science operating segment has
seen volume demand for antibodies, antigens, and other reagents increase with large diagnostic
manufacturing companies.
Financial discipline is also 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.
2007 | 2006 | 2005 | ||||||||||
Gross profit |
61 | % | 60 | % | 59 | % | ||||||
Operating expenses |
32 | % | 35 | % | 37 | % | ||||||
Operating income |
28 | % | 25 | % | 22 | % | ||||||
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Operating Segments:
Meridians 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
from quarter to quarter 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 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. Meridian believes that the overall breadth of its product lines serves to reduce the
variability in consolidated sales from quarter to quarter.
Results of Operations:
Overview
Fourth quarter
Net earnings for the fourth quarter of fiscal 2007 increased 36% to $6,444,000, or $0.16 per
diluted share (increased 33%) from net earnings for the fourth quarter of fiscal 2006 of
$4,730,000, or $0.12 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 2007 were $32,386,000, an increase of $3,736,000 or 13% compared to the
fourth quarter of fiscal 2006.
During the fourth quarter of fiscal 2006, Meridian determined that the carrying value of a supply
contract with the United States Department of Defense related to the Life Science operating segment
had become impaired and recorded such impairment to general and administrative expenses in the
amount of $826,000. 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 Program lowered the amount of materials to be supplied under
the contract. During March 2007, the Department informed Meridian
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that it would not be exercising the optional renewal period from April 1, 2007 through March 31,
2008. Meridian does not expect to supply any more materials under this contract, and as of
September 30, 2007, this contract had no carrying value.
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. See Note 1(g) to the consolidated financial statements
contained herein.
Fiscal Year
Net earnings for fiscal 2007 increased 46% to $26,721,000, or $0.66 per diluted share (increased
43%) from net earnings for fiscal 2006 of $18,333,000, or $0.46 per diluted share. Results of
operations for fiscal 2007 compared to fiscal 2006 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 7 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
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.
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2007 | 2006 | Change | ||||||||||
Net Earnings - |
||||||||||||
US GAAP basis |
$ | 26,721 | $ | 18,333 | 46 | % | ||||||
Tax benefit not expected to recur in the future |
(2,425 | ) | | (100 | )% | |||||||
Excluding tax benefit |
$ | 24,296 | $ | 18,333 | 33 | % | ||||||
2007 | 2006 | Change | ||||||||||
Net Earnings per Basic Common Share - |
||||||||||||
US GAAP basis |
$ | 0.67 | $ | 0.47 | 43 | % | ||||||
Tax benefit not expected to recur in the future |
(0.06 | ) | | (100 | )% | |||||||
Excluding tax benefit |
$ | 0.61 | $ | 0.47 | 30 | % | ||||||
2007 | 2006 | Change | ||||||||||
Net Earnings per Diluted Common Share - |
||||||||||||
US GAAP basis |
$ | 0.66 | $ | 0.46 | 43 | % | ||||||
Tax benefit not expected to recur in the future |
(0.06 | ) | | (100 | )% | |||||||
Excluding tax benefit |
$ | 0.60 | $ | 0.46 | 30 | % | ||||||
Fiscal Year Ended September 30, 2007 Compared to Fiscal Year Ended September 30, 2006
Net sales
Overall, net sales increased 13% for fiscal 2007 compared to fiscal 2006. Net sales for the US
Diagnostics operating segment increased $9,124,000, or 14%, for the European Diagnostics operating
segment increased $3,735,000, or 19%, and for the Life Science operating segment increased
$1,691,000, or 7%.
For the US Diagnostics operating segment, 45% of the sales increase was related to growth in C.
difficile products (increased $4,099,000), reflecting volume increases for ImmunoCard®
Toxins A & B and PremierTM Toxins A & B. Sales of respiratory products (increased
$1,432,000) also contributed to the increase, driven by increased market share and increased
purchases by one national distributor. Meridians respiratory products include diagnostic tests
for influenza, Respiratory Syncytial Virus (RSV), and Mycoplasma. H. pylori sales (increased
$1,625,000) contributed to the increase due to increased managed care efforts, issuance of AGA
guidelines recommending direct testing, and increased marketing of PremierTM Platinum
HpSA PLUS. Volume increases for parasitology products (increased $1,063,000) related to the exit
of a competitor from the marketplace, food borne products (increased $1,603,000) related to the
2007 launch of ImmunoCard STAT!® EHEC, and volume increases in specimen transport
products ($501,000) also contributed to favorable variances to fiscal 2006. These favorable
variances more than offset an unfavorable variance of $809,000 for microbiology products related to
reduced purchases of one product by one international customer. Two national distributors
accounted for 51% and 47% of total sales for the US Diagnostics operating segment for fiscal 2007
and 2006, respectively.
For the European Diagnostics operating segment, the sales increase includes currency translation
gains in the amount of $1,769,000. Sales in local currency, the Euro, increased 10%. The local
currency increase was driven by C. difficile products ($1,559,000), including
ImmunoCardÒ Toxins A & B.
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For the Life Science operating segment, the sales increase was primarily attributable to buying
patterns and volume growth in make-to-order bulk antigens and antibodies, offset by lower sales
activity from contract research and development and contract manufacturing services. Sales of
made-to-order bulk antigens and antibodies to one customer accounted for 27% and 18% of total sales
for the Life Science Operating segment for fiscal 2007 and 2006, respectively.
For all operating segments combined, international sales were $38,691,000, or 31% of total sales,
for fiscal 2007, compared to $34,557,000, or 32% of total sales, in fiscal 2006. Combined domestic
exports for the US Diagnostics and Life Science operating segments were $15,128,000 for fiscal
2007, compared to $14,728,000 in fiscal 2006. The remaining international sales were generated by
the European Diagnostics operating segment.
Gross Profit
Gross profit increased 16% for fiscal 2007 compared to fiscal 2006. Gross profit margins were 61%
for fiscal 2007 compared to 60% for fiscal 2006. This increase reflects higher margins commanded
by volume increases in rapid tests, such as ImmunoCard® Toxins A & B and operating
efficiencies. We have also seen improvements in gross profit margins related to automation
initiatives and related efficiencies in diagnostic production areas.
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.
Operating Expenses
Operating expenses increased 6% for fiscal 2007 compared to fiscal 2006. The overall increase in
operating expenses for fiscal 2007 is discussed below.
Research and development expenses increased 27% for fiscal 2007 compared to fiscal 2006, and as a
percentage of sales, were 5% in fiscal 2007 compared to 4% in fiscal 2006. Of this increase,
$1,229,000 related to the US Diagnostics operating segment and $57,000 related to the Life Science
operating segment. The increase for the US Diagnostics operating segment was primarily
attributable to clinical trial and other costs associated with new product development, including
planned headcount additions, as well as increased stock compensation expense.
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Selling and marketing expenses increased 3%, for fiscal 2007 compared to fiscal 2006, and as a
percentage of sales, decreased to 14% for fiscal 2007 from 15% for fiscal 2006. Of this increase,
$469,000 related to the European Diagnostics operating segment, offset by decreases of $34,000
related to the Life Science operating segment and $9,000 for the US Diagnostics operating segment.
The increase for the European Diagnostics operating segment was primarily attributable to
fluctuations in the Euro currency and one planned headcount addition. The decrease for the US
Diagnostics operating segment 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 compensation costs.
General and administrative expenses increased 3%, for fiscal 2007 compared to fiscal 2006, and as
a percentage of sales, decreased from 15% in fiscal 2006 to 14% in fiscal 2007. Of this increase,
$1,523,000 related to the US Diagnostics operating segment, offset by decreases of $806,000
related to the Life Science operating segment and $309,000 related to the European Diagnostics
operating segment. The increase for the US Diagnostics operating segment 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
decrease for the Life Science operating segment was primarily attributable to the 2006 impairment
of the supply contract with the United States Department of Defense. See Note 1(i) to the
consolidated financial statements contained herein. The decrease for the European Diagnostics
operating segment was primarily attributable to expenses connected with an employee matter in
fiscal 2006, which were covered by the aforementioned insurance recovery.
Effective July 1, 2005, Meridian adopted the provisions of SFAS No. 123(R), Share-Based Payment, in
accounting for its stock option plans. The amount of stock-based compensation expense reported for
fiscal 2007, fiscal 2006, and fiscal 2005 was $2,632,000, $1,082,000, and $279,000, respectively.
During November 2006, Meridian granted to certain employees, 293,250 stock options that were
contingent upon Meridian achieving a specified income level for fiscal 2007. Meridians fiscal
2007 net income surpassed the minimum level, and thus, these stock options were earned and are now
exercisable over a vesting period. Fiscal 2007 stock-based compensation cost for these stock
options, in accordance with SFAS No. 123(R), was approximately $973,000 and was recorded in the
fourth quarter.
Operating Income
Operating income increased 30% in fiscal 2007, as a result of the factors discussed above.
Other Income and Expense
Interest income was $1,642,000 for fiscal 2007, compared to $1,123,000 for fiscal 2006. This
increase was driven
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by higher interest yields and higher investment balances in fiscal 2007.
Interest expense declined 70% for fiscal 2007 compared to fiscal 2006. This decrease was
attributable to the positive effects of the debenture conversion and redemption transactions
discussed under Liquidity and Capital Resources herein. As of September 30, 2007, there were no
debentures outstanding.
Income Taxes
The effective rate for income taxes was 27% for fiscal 2007 and 35% for fiscal 2006. The decrease
in the effective tax rate was primarily attributable to a discrete adjustment to tax reserves in
the third quarter in the amount of $2,425,000. This discrete adjustment reduced the effective tax
rate by 7 points. See Note 7 to the consolidated financial statements included herein for a
complete discussion of this matter.
Fiscal Year Ended September 30, 2006 Compared to Fiscal Year Ended September 30, 2005
Net sales
Overall, net sales increased 17% for fiscal 2006 compared to fiscal 2005. Net sales for the US
Diagnostics operating segment increased $12,236,000, or 23%, for the European Diagnostics operating
segment increased $2,010,000, or 11%, and for the Life Science operating segment increased
$1,202,000, or 6%.
For the US Diagnostics operating segment, 46% of the sales increase was related to growth in C.
difficile products (increased $5,682,000), reflecting the market expansion and gains in market
share related to the 2005 launch of ImmunoCardÒ Toxins A & B. Sales of
respiratory products (increased $1,819,000) also contributed to the increase, driven by growth in
international markets and favorable changes in insurance reimbursement policies. Meridians
respiratory products include diagnostic tests for influenza, Respiratory Syncytial Virus (RSV), and
mycoplasma. H. pylori sales (increased $996,000) contributed to the increase due to increased
testing and positive results from focused marketing efforts on the managed care sector. Sales
increases for parasitology products (increased $1,019,000), fungal products (increased $860,000),
food borne products (increased $632,000), rotavirus products (increased $565,000) and microbiology
products ($480,000) also contributed to favorable variances to fiscal 2005.
For the European Diagnostics operating segment, the sales increase offsets currency translation
losses in the amount of approximately $662,000. Sales in local currency, the Euro, increased 15%.
The local currency increase was driven by market increases in sales of H. pylori products
($1,182,000). Increases in sales of C. difficile products ($901,000), including
ImmunoCardÒ Toxins A & B, also contributed to the increase.
For the Life Science operating segment, the sales increase was primarily attributable to the
inclusion of OEM Concepts for a full year in fiscal 2006, compared to eight months in fiscal 2005.
This was partially offset by
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shifts in buying patterns by one large diagnostic manufacturing customer and one large defense
customer, as well as the timing and number of contract services arrangements. Sales of
made-to-order bulk antigens and antibodies to one customer accounted for 18% and 23% of total sales
for the Life Science Operating segment for fiscal 2006 and 2005, respectively.
For all operating segments combined, international sales were $34,557,000, or 32% of total sales,
for fiscal 2006, compared to $30,232,000, or 33% of total sales, in fiscal 2005. Combined domestic
exports for the US Diagnostics and Life Science operating segments were $14,728,000 for fiscal
2006, compared to $12,414,000 in fiscal 2005. The remaining international sales were generated by
the European Diagnostics operating segment.
Gross Profit
Gross profit increased 18% for fiscal 2006 compared to fiscal 2005. Gross profit margins were 60%
for fiscal 2006 compared to 59% for fiscal 2005. This increase reflects higher margins commanded
by new rapid tests, such as ImmunoCard® Toxins A & B and operating efficiencies.
Meridians 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.
Operating Expenses
Operating expenses increased 9% for fiscal 2006 compared to fiscal 2005. The overall increase in
operating expenses for fiscal 2006 is discussed below.
Research and development expenses increased 24% for fiscal 2006 compared to fiscal 2005, and as a
percentage of sales, were 4% in fiscal 2006 and fiscal 2005. Of this increase, $299,000 related
to the US Diagnostics operating segment and $634,000 related to the Life Science operating
segment. The US Diagnostics operating segment increase was primarily attributable to increased
stock compensation expense. For the Life Science operating segment, during fiscal 2005, research
and development scientists were performing contract work for third-party customers, and thus,
their related costs were classified in cost of sales. During fiscal 2006, their efforts and
activities were primarily focused on internal research and development work, and therefore charged
to research and development expense, rather than being classified in cost of sales or inventory.
The increase for the Life Science operating segment reflects the classification of such costs.
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Selling and marketing expenses increased 10%, for fiscal 2006 compared to fiscal 2005, and as a
percentage of sales, decreased from 16% for fiscal 2005 to 15% for fiscal 2006. Of this increase,
$1,195,000 related to the US Diagnostics operating segment and $475,000 related to the Life Science
operating segment, partially offset by a decrease of $180,000 for the European Diagnostics
operating segment. The increase for the US Diagnostics operating segment was primarily
attributable to sales administration fees to group purchasing organizations and incentive
compensation associated with higher sales levels, as well as higher salaries and benefits costs.
The increase for the Life Science operating segment was primarily due to business development costs
and a full year of costs for the OEM Concepts business, acquired during the second quarter of
fiscal 2005. The decrease for the European Diagnostics operating segment was primarily
attributable to fluctuations in the Euro currency.
General and administrative expenses increased 5%, for fiscal 2006 compared to fiscal 2005, and as
a percentage of sales, decreased from 17% in fiscal 2005 to 15% in fiscal 2006. Of this increase,
$18,000 related to the US Diagnostics operating segment, $679,000 related to the Life Science
operating segment and $105,000 related to the European Diagnostics operating segment. The
increase for the US Diagnostics operating segment was primarily attributable to increased salaries
and benefits costs and increased stock compensation expense, offset by an insurance recovery
received and decreased legal and professional fees related to efficiencies in reporting under the
Sarbanes-Oxley Act. The increase for the Life Science operating segment was primarily
attributable to the impairment of a supply contract related to the acquisition of OEM Concepts.
See Note 1(i) to the consolidated financial statements contained herein.
Operating Income
Operating income increased 32% in fiscal 2006, as a result of the factors discussed above.
Other Income and Expense
Interest income was $1,123,000 for fiscal 2006, and related primarily to interest earned on
proceeds from the September 2005 common share offering that have been primarily invested in
tax-exempt securities.
Interest expense declined 83% for fiscal 2006 compared to fiscal 2005. This decrease was
attributable to the positive effects of the debenture conversion and redemption transactions
discussed under Liquidity and Capital Resources herein.
Income Taxes
The effective rate for income taxes was 35% for fiscal 2006 and 36% for fiscal 2005. The decrease
in the effective tax rate was primarily attributable to the favorable effects of tax-exempt
interest and domestic production incentives under the American Jobs Creation Act.
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Liquidity and Capital Resources:
Comparative Cash Flow Analysis
Our operating cash flow and financing requirements are determined by analyses of operating and
capital spending budgets and consideration of acquisition plans. We have historically maintained
revolving line of credit availability to respond quickly to acquisition opportunities. This
revolving line of credit is supplemented by the proceeds from a September 2005 common share
offering, which are invested in tax-exempt, cash-equivalent securities and institutional
money-market funds.
Net cash provided by operating activities increased 20% to $26,602,000 in fiscal 2007. This
increase was primarily attributable to higher earnings levels. The discrete tax reserve adjustment
in the amount of $2,425,000 was non-cash in nature.
Net cash used in investing activities was $443,000 for fiscal 2007, compared to $8,689,000 for
fiscal 2006. This decrease was primarily attributable to lower acquisition earnout payments in
fiscal 2007 and proceeds from sales of short-term auction rate securities in fiscal 2007 that were
purchased in fiscal 2006.
Net cash used in financing activities was $13,291,000 for fiscal 2007, compared to $10,225,000 for
fiscal 2006. This increase was primarily attributable to a 43% increase in dividend payments,
offset by $914,000 in additional proceeds and tax benefits from the exercise of stock options.
Dividend payments in fiscal 2007 reflect increased dividend rates and common shares outstanding
related to stock option exercises and bond conversions.
Net cash flows from operating activities are anticipated to fund working capital requirements and
dividends during fiscal 2008.
Capital Resources
During August 2007, Meridian completed the renewal of its credit facility with its commercial
bank. The amount of the credit facility is $30,000,000, which expires September 15, 2012. As
of November 28, 2007, 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.
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The Viral Antigens acquisition, completed 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.
The OEM Concepts acquisition, completed in fiscal 2005, provides for additional purchase
consideration up to a maximum remaining amount of $1,819,000, 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 $118,000 related to calendar 2006 was paid from operating cash flows during the
second quarter of fiscal 2007. Earnout consideration in the amount of $152,000 for the first
nine months of calendar 2007 is accrued in the accompanying consolidated balance sheet.
Meridians capital expenditures are estimated to be approximately $5,000,000 to $6,000,000 for
fiscal 2008, 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 capacity
expansion for the Maine facility.
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Known Contractual Obligations:
Known contractual obligations and their related due dates were as follows as of September 30, 2007
(dollars in thousands):
Less than | More than | |||||||||||||||||||
Total | 1 Year | 1-3 Years | 4-5 Years | 5 Years | ||||||||||||||||
Operating leases (1) |
$ | 1,516 | $ | 599 | $ | 822 | $ | 95 | $ | | ||||||||||
Purchase obligations (2) |
9,690 | 9,305 | 385 | | | |||||||||||||||
OEM Concepts earnout (3) |
1,971 | 152 | 1,819 | | | |||||||||||||||
Total |
$ | 13,177 | $ | 10,056 | $ | 3,026 | $ | 95 | $ | | ||||||||||
(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. |
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 $447,000 in fiscal 2008. 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 $1,740,000) 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
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over a five-year period, which began in fiscal
2007. A payment equal to 20,000,000 Japanese Yen 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 6 to the consolidated
financial statements contained herein.
Other
Meridian does not utilize any special-purpose financing vehicles or have any undisclosed off
balance sheet arrangements. Similarly, the Company holds no fair-value contracts for which a lack
of marketplace quotations would necessitate the use of fair value techniques.
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 contractual forward exchange
contracts to hedge cash flows from intercompany sales between our US parent company and its Italian
affiliate. The counterparties to these
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contracts are major financial institutions. Hedging
activities are further discussed in Note 6 to the consolidated financial statements.
Concentration of Customers/Products Risk
Our US Diagnostic operating segments sales through two distributors were 51% of the US Diagnostics
operating segments total sales for fiscal 2007 or 31% of consolidated total sales for fiscal 2007.
Three internally developed products, Premierä Platinum HpSA PLUS, Premierä Toxins A &
B, and ImmunoCardÒ Toxins A & B, accounted for 39% of our US Diagnostics operating
segments third-party sales during fiscal 2007. These same three products accounted for 27% of our
European Diagnostics operating segments third party sales and 31% of our total consolidated sales
for fiscal 2007.
Our Life Science operating segments sales of purified antigens and reagents to one customer were
27% of the Life Science operating segments total sales for fiscal 2007 or 5% of our consolidated
total sales for fiscal 2007. Our Life Science operating segment has five other significant
customers who purchase antigens, antibodies and reagents, which together comprised 19% of the
operating segments total sales for fiscal 2007.
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.
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-
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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 recognized upon delivery of product and acceptance by the
customer.
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. Such
reserves were $1,162,000 and $1,158,000 at September 30, 2007 and 2006, 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.
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, Goodwill and Other Intangible Assets 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
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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 have been no events or circumstances in fiscal 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.
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.
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
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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. Our tax provisions take into consideration the judgmental nature of
certain tax positions through the establishment of reserves for differences between the probable
tax determinations and the as filed tax positions of certain assets and liabilities. 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(q) to the Consolidated Financial Statements.
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
38 | ||||
39 | ||||
41 | ||||
42 | ||||
43 | ||||
45 | ||||
46 | ||||
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, 2007.
/s/ William J. Motto
William J. Motto
Chairman of the Board and
Chief Executive Officer
November 30, 2007
William J. Motto
Chairman of the Board and
Chief Executive Officer
November 30, 2007
/s/ Melissa Lueke
Melissa Lueke
Vice President and
Chief Financial Officer
November 30, 2007
Melissa Lueke
Vice President and
Chief Financial Officer
November 30, 2007
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Report of Independent Registered Public Accounting Firm
Board of Directors and Shareholders of
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, 2007 and 2006, and the related consolidated
statements of operations, shareholders equity, and cash flows for each of the three years in the
period ended September 30, 2007. We also have audited Meridian Bioscience, Inc.s internal control
over financial reporting as of September 30, 2007, 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, for maintaining effective internal control over financial reporting, and for its
assessment of the effectiveness of internal control over financial reporting, included in the
accompanying Management's Report on Internal Control over Financial Reporting. Our responsibility is to express
an opinion on these financial statements and an opinion on Meridian Bioscience, Inc.s 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 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.
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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,
2007 and 2006, and the results of their operations and their cash flows for each of the three years
in the period ended September 30, 2007 in conformity with accounting principles generally accepted
in the United States of America. Also in our opinion, Meridian Bioscience, Inc. and subsidiaries
maintained, in all material respects, effective internal control over financial reporting as of
September 30, 2007, 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.
Our audit was conducted for the purpose of forming an opinion on the consolidated financial
statements taken as a whole. The accompanying Schedule II is presented for purposes of additional
analysis and is not a required part of the basic financial statements. The information for each of
the three years in the period ended September 30, 2007 included in this schedule has been subjected
to the auditing procedures applied in our audits of the basic financial statements as of
September 30, 2007 and 2006 and for each of the three years in the period ended September 30, 2007
and, in our opinion, is fairly stated in all material respects in relation to the basic financial
statements taken as a whole.
/s/ GRANT THORNTON LLP
Cincinnati, Ohio
November 30, 2007
Cincinnati, Ohio
November 30, 2007
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CONSOLIDATED STATEMENTS OF OPERATIONS (in thousands, except per share data)
Meridian Bioscience, Inc. and Subsidiaries
For the Year Ended September 30, | 2007 | 2006 | 2005 | |||||||||
Net Sales |
$ | 122,963 | $ | 108,413 | $ | 92,965 | ||||||
Cost of Sales |
48,023 | 43,729 | 38,075 | |||||||||
Gross Profit |
74,940 | 64,684 | 54,890 | |||||||||
Operating Expenses: |
||||||||||||
Research and development |
6,085 | 4,799 | 3,866 | |||||||||
Selling and marketing |
17,124 | 16,698 | 15,208 | |||||||||
General and administrative |
16,701 | 16,293 | 15,491 | |||||||||
Total operating expenses |
39,910 | 37,790 | 34,565 | |||||||||
Operating Income |
35,030 | 26,894 | 20,325 | |||||||||
Other Income (Expense): |
||||||||||||
Interest income |
1,642 | 1,123 | 43 | |||||||||
Interest expense |
(38 | ) | (128 | ) | (770 | ) | ||||||
Other, net |
48 | 177 | 107 | |||||||||
Total other income (expense) |
1,652 | 1,172 | (620 | ) | ||||||||
Earnings Before Income Taxes |
36,682 | 28,066 | 19,705 | |||||||||
Income Tax Provision |
9,961 | 9,733 | 7,067 | |||||||||
Net Earnings |
$ | 26,721 | $ | 18,333 | $ | 12,638 | ||||||
Earnings Per Share Data: |
||||||||||||
Basic earnings per common share |
$ | 0.67 | $ | 0.47 | $ | 0.36 | ||||||
Diluted earnings per common share |
0.66 | 0.46 | 0.35 | |||||||||
Common shares used for basic earnings per common share |
39,584 | 39,132 | 35,211 | |||||||||
Effect of dilutive stock options |
1,154 | 1,032 | 945 | |||||||||
Common shares used for diluted earnings per common share |
40,738 | 40,164 | 36,156 | |||||||||
Dividends declared per common share |
$ | 0.40 | $ | 0.28 | $ | 0.21 | ||||||
Anti-dilutive Securities: |
||||||||||||
Common share options |
| 32 | 2 | |||||||||
Convertible debentures |
| 279 | 380 | |||||||||
All share and per share data has been adjusted for the three-for-two stock splits that occurred on
May 11, 2007 and September 2, 2005.
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, | 2007 | 2006 | 2005 | |||||||||
Cash Flows From Operating Activities |
||||||||||||
Net earnings |
$ | 26,721 | $ | 18,333 | $ | 12,638 | ||||||
Non-cash items: |
||||||||||||
Depreciation of property, plant and equipment |
2,764 | 2,717 | 2,597 | |||||||||
Amortization of intangible assets and deferred issuance costs |
1,635 | 2,572 | 1,655 | |||||||||
Deferred income taxes |
800 | 47 | (243 | ) | ||||||||
Stock compensation expense |
2,632 | 1,082 | 279 | |||||||||
Tax reserve adjustment |
(2,425 | ) | | | ||||||||
(Gain) loss on disposition of fixed assets |
5 | 38 | (7 | ) | ||||||||
Change in current assets, net of acquisition |
(3,011 | ) | (3,146 | ) | (1,100 | ) | ||||||
Change in current liabilities, net of acquisition |
(2,145 | ) | 920 | 2,455 | ||||||||
Other, net |
(374 | ) | (408 | ) | (87 | ) | ||||||
Net cash provided by operating activities |
26,602 | 22,155 | 18,187 | |||||||||
Cash Flows From Investing Activities |
||||||||||||
Acquisition earnout payments |
(971 | ) | (1,494 | ) | (678 | ) | ||||||
Purchases of property, plant and equipment |
(3,211 | ) | (3,120 | ) | (2,590 | ) | ||||||
Proceeds from dispositions of property, plant and equipment |
4 | 47 | 14 | |||||||||
Acquisition of OEM Concepts, Inc. |
| | (6,383 | ) | ||||||||
Purchases of short-term investments |
| (6,000 | ) | | ||||||||
Proceeds from sales of short-term investments |
4,000 | 2,000 | | |||||||||
Other intangibles acquired |
(265 | ) | (122 | ) | (10 | ) | ||||||
Net cash used in investing activities |
(443 | ) | (8,689 | ) | (9,647 | ) | ||||||
Cash Flows From Financing Activities |
||||||||||||
Repayment of debt obligations |
(29 | ) | (790 | ) | (3,061 | ) | ||||||
Dividends paid |
(15,836 | ) | (11,095 | ) | (7,200 | ) | ||||||
Proceeds and tax benefits from exercises of stock options |
2,574 | 1,660 | 3,302 | |||||||||
Proceeds from issuance of common shares |
| | 29,925 | |||||||||
Common share issuance costs |
| | (345 | ) | ||||||||
Other |
| | (3 | ) | ||||||||
Net cash provided by (used in) financing activities |
(13,291 | ) | (10,225 | ) | 22,618 | |||||||
Effect of Exchange Rate Changes on Cash and Equivalents |
184 | 22 | (56 | ) | ||||||||
Net Increase in Cash and Equivalents |
13,052 | 3,263 | 31,102 | |||||||||
Cash and Equivalents at Beginning of Period |
36,348 | 33,085 | 1,983 | |||||||||
Cash and Equivalents at End of Period |
$ | 49,400 | $ | 36,348 | $ | 33,085 | ||||||
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, | 2007 | 2006 | ||||||
Assets |
||||||||
Current Assets: |
||||||||
Cash and equivalents |
$ | 49,400 | $ | 36,348 | ||||
Short term investments |
| 4,000 | ||||||
Accounts receivable, less allowances of $258 in 2007 and $408 in 2006 |
22,651 | 19,645 | ||||||
Inventories |
18,171 | 16,989 | ||||||
Prepaid expenses and other current assets |
2,147 | 2,109 | ||||||
Deferred income taxes |
1,376 | 1,651 | ||||||
Total current assets |
93,745 | 80,742 | ||||||
Property, Plant and Equipment, at Cost: |
||||||||
Land |
890 | 701 | ||||||
Buildings and improvements |
16,907 | 15,963 | ||||||
Machinery, equipment and furniture |
24,619 | 22,902 | ||||||
Construction in progress |
1,290 | 870 | ||||||
Subtotal |
43,706 | 40,436 | ||||||
Less-accumulated depreciation and amortization |
25,395 | 22,629 | ||||||
Net property, plant and equipment |
18,311 | 17,807 | ||||||
Other Assets: |
||||||||
Deferred debenture offering costs, net |
| 106 | ||||||
Goodwill |
9,964 | 9,864 | ||||||
Other intangible assets, net |
9,457 | 10,816 | ||||||
Restricted cash |
1,000 | 1,000 | ||||||
Other assets |
221 | 193 | ||||||
Total other assets |
20,642 | 21,979 | ||||||
Total assets |
$ | 132,698 | $ | 120,528 | ||||
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, | 2007 | 2006 | ||||||
Liabilities and Shareholders Equity |
||||||||
Current Liabilities: |
||||||||
Accounts payable |
$ | 4,704 | $ | 3,671 | ||||
Accrued payroll costs |
7,541 | 7,896 | ||||||
Purchase business combination liability |
152 | 937 | ||||||
Other accrued expenses |
4,008 | 3,955 | ||||||
Income taxes payable |
662 | 4,158 | ||||||
Total current liabilities |
17,067 | 20,617 | ||||||
Convertible Subordinated Debentures |
| 1,803 | ||||||
Deferred Income Taxes |
2,683 | 3,758 | ||||||
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, 39,847,391 and
39,235,777 shares issued |
| | ||||||
Additional paid-in capital |
82,209 | 74,950 | ||||||
Retained earnings |
30,375 | 19,490 | ||||||
Accumulated other comprehensive income (loss) |
364 | (90 | ) | |||||
Total shareholders equity |
112,948 | 94,350 | ||||||
Total liabilities and shareholders equity |
$ | 132,698 | $ | 120,528 | ||||
The accompanying notes are an integral part of these consolidated financial statements.
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CONSOLIDATED STATEMENTS OF SHAREHOLDERSEQUITY (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, 2004 |
33,685 | (18 | ) | (32 | ) | 25,936 | 6,814 | (294 | ) | 32,424 | ||||||||||||||||||||||
Cash dividends paid $0.21 per share |
| | | | (7,200 | ) | | (7,200 | ) | |||||||||||||||||||||||
Exercise of stock options, net of tax |
863 | | | 3,956 | | | 3,956 | |||||||||||||||||||||||||
Stock compensation expense |
| | | 279 | | | 279 | |||||||||||||||||||||||||
Debenture conversions |
1,662 | | | 11,817 | | | 11,817 | |||||||||||||||||||||||||
Common share offering, net |
2,700 | | | 29,580 | | | 29,580 | |||||||||||||||||||||||||
Comprehensive income: |
||||||||||||||||||||||||||||||||
Net earnings |
| | | | 12,638 | | $ | 12,638 | 12,638 | |||||||||||||||||||||||
Foreign currency translation adjustment |
| | | | | (161 | ) | (161 | ) | (161 | ) | |||||||||||||||||||||
Comprehensive income |
$ | 12,477 | ||||||||||||||||||||||||||||||
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, net of tax |
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 tax benefits |
| | | | | 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, net of tax |
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 tax benefits |
(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 | ||||||||||||||||||||
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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(g), 1(h), 1(i), 1(j), 1(l), 1(m), 7 and 8(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 (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 Equivalents 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. |
(f) | Short-term Investments Auction-rate securities are separately classified as short-term investments in the consolidated financial statements and are accounted for as available-for-sale securities 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 until realized. The carrying value of |
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these securities was equal to their fair value as of September 30, 2006. We did not hold any auction-rate securities at September 30, 2007. There were no realized gains or losses from the sales of these securities during fiscal 2007. |
(g) | Inventories - Inventories are stated at the lower of cost or market. Cost is determined on a first-in, first-out basis (FIFO). |
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 $1,162,000 and $1,158,000 at September 30, 2007 and 2006, 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 effects of the change as it relates to our consolidated financial statements for the periods presented are as follows: |
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Statement of Operations (dollars in thousands)
Nine Months Ended June 30, 2007
Effect of | ||||||||||||
LIFO Method | FIFO Method | Change | ||||||||||
Net Sales |
$ | 90,577 | $ | 90,577 | $ | | ||||||
Cost of Sales |
34,871 | 34,826 | (45 | ) | ||||||||
Gross Profit |
55,706 | 55,751 | 45 | |||||||||
Operating Expenses |
29,356 | 29,356 | | |||||||||
Operating Income |
26,350 | 26,395 | 45 | |||||||||
Other Income (Expense) |
1,169 | 1,169 | | |||||||||
Earnings Before Income Taxes |
27,519 | 27,564 | 45 | |||||||||
Income Tax Provision |
7,270 | 7,287 | 17 | |||||||||
Net Earnings |
$ | 20,249 | $ | 20,277 | $ | 28 | ||||||
Earnings Per Share Data: |
||||||||||||
Basic earnings per common share |
$ | 0.51 | $ | 0.51 | $ | | ||||||
Diluted earnings per common share |
$ | 0.50 | $ | 0.50 | $ | |
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Statement of Operations (dollars in thousands)
Year Ended September 30, 2006
Effect of | ||||||||||||
LIFO Method | FIFO Method | Change | ||||||||||
Net Sales |
$ | 108,413 | $ | 108,413 | $ | | ||||||
Cost of Sales |
43,742 | 43,729 | (13 | ) | ||||||||
Gross Profit |
64,671 | 64,684 | 13 | |||||||||
Operating Expenses |
37,790 | 37,790 | | |||||||||
Operating Income |
26,881 | 26,894 | 13 | |||||||||
Other Income (Expense) |
1,172 | 1,172 | | |||||||||
Earnings Before Income Taxes |
28,053 | 28,066 | 13 | |||||||||
Income Tax Provision |
9,728 | 9,733 | 5 | |||||||||
Net Earnings |
$ | 18,325 | $ | 18,333 | $ | 8 | ||||||
Earnings Per Share Data: |
||||||||||||
Basic earnings per common share |
$ | 0.47 | $ | 0.47 | $ | | ||||||
Diluted earnings per common share |
$ | 0.46 | $ | 0.46 | $ | |
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Statement of Operations (dollars in thousands)
Year Ended September 30, 2005
Effect of | ||||||||||||
LIFO Method | FIFO Method | Change | ||||||||||
Net Sales |
$ | 92,965 | $ | 92,965 | $ | | ||||||
Cost of Sales |
38,184 | 38,075 | (109 | ) | ||||||||
Gross Profit |
54,781 | 54,890 | 109 | |||||||||
Operating Expenses |
34,565 | 34,565 | | |||||||||
Operating Income |
20,216 | 20,325 | 109 | |||||||||
Other Income (Expense) |
(620 | ) | (620 | ) | | |||||||
Earnings Before Income Taxes |
19,596 | 19,705 | 109 | |||||||||
Income Tax Provision |
7,031 | 7,067 | 36 | |||||||||
Net Earnings |
$ | 12,565 | $ | 12,638 | $ | 73 | ||||||
Earnings Per Share Data: |
||||||||||||
Basic earnings per common share |
$ | 0.36 | $ | 0.36 | $ | | ||||||
Diluted earnings per common share |
$ | 0.35 | $ | 0.35 | $ | |
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Balance Sheet (dollars in thousands)
June 30, 2007
Effect of | ||||||||||||
LIFO Method | FIFO Method | Change | ||||||||||
Current assets: |
||||||||||||
Inventories |
$ | 18,825 | $ | 18,179 | $ | (646 | ) | |||||
Deferred income taxes |
1,141 | 1,358 | 217 | |||||||||
Aggregated other current assets |
66,821 | 66,821 | | |||||||||
Total current assets |
86,787 | 86,358 | (429 | ) | ||||||||
Aggregated other assets, net |
38,881 | 38,881 | | |||||||||
Total assets |
$ | 125,668 | $ | 125,239 | $ | (429 | ) | |||||
Total liabilities |
$ | 16,855 | $ | 16,855 | $ | | ||||||
Retained earnings |
28,705 | 28,276 | (429 | ) | ||||||||
Other shareholders equity |
80,108 | 80,108 | | |||||||||
Total shareholders equity |
108,813 | 108,384 | (429 | ) | ||||||||
Total liabilities and shareholders equity |
$ | 125,668 | $ | 125,239 | $ | (429 | ) | |||||
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Balance Sheet (dollars in thousands)
September 30, 2006
Effect of | ||||||||||||
LIFO Method | FIFO Method | Change | ||||||||||
Current assets: |
||||||||||||
Inventories |
$ | 17,680 | $ | 16,989 | $ | (691 | ) | |||||
Deferred income taxes |
1,387 | 1,651 | 264 | |||||||||
Aggregated other current assets |
62,102 | 62,102 | | |||||||||
Total current assets |
81,169 | 80,742 | (427 | ) | ||||||||
Aggregated other assets, net |
39,786 | 39,786 | | |||||||||
Total assets |
$ | 120,955 | $ | 120,528 | $ | (427 | ) | |||||
Total liabilities |
$ | 26,178 | $ | 26,178 | $ | | ||||||
Retained earnings |
19,917 | 19,490 | (427 | ) | ||||||||
Other shareholders equity |
74,860 | 74,860 | | |||||||||
Total shareholders equity |
94,777 | 94,350 | (427 | ) | ||||||||
Total liabilities and shareholders equity |
$ | 120,955 | $ | 120,528 | $ | (427 | ) | |||||
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Balance Sheet (dollars in thousands)
September 30, 2005
Effect of | ||||||||||||
LIFO Method | FIFO Method | Change | ||||||||||
Current assets: |
||||||||||||
Inventories |
$ | 16,785 | $ | 16,081 | $ | (704 | ) | |||||
Deferred income taxes |
1,258 | 1,527 | 269 | |||||||||
Aggregated other current assets |
52,117 | 52,117 | | |||||||||
Total current assets |
70,160 | 69,725 | (435 | ) | ||||||||
Aggregated other assets, net |
40,409 | 40,409 | | |||||||||
Total assets |
$ | 110,569 | $ | 110,134 | $ | (435 | ) | |||||
Total liabilities |
$ | 26,801 | $ | 26,801 | $ | | ||||||
Retained earnings |
12,687 | 12,252 | (435 | ) | ||||||||
Other shareholders equity |
71,081 | 71,081 | | |||||||||
Total shareholders equity |
83,768 | 83,333 | (435 | ) | ||||||||
Total liabilities and shareholders equity |
$ | 110,569 | $ | 110,134 | $ | (435 | ) | |||||
(h) | 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 5 to 33 years
Machinery, equipment, and furniture 3 to 10 years
(i) | 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 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 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). During fiscal 2006, the change in goodwill was an increase of $1,085,000. This change |
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consisted of an increase related to the Viral Antigens earnout obligation for fiscal
2006 in the amount of $853,000 (Life Science operating segment), an increase related to the OEM
Concepts earnout obligations for calendar 2005 and the first nine months of calendar 2006 in
the amount of $265,000 (Life Science operating segment), offset by a decrease of $33,000
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,
2007 and 2006 is as follows (dollars in thousands).
Wtd Avg | 2007 | 2006 | ||||||||||||||||||
Amort | Gross | 2007 | Gross | 2006 | ||||||||||||||||
Period | Carrying | Accumulated | Carrying | Accumulated | ||||||||||||||||
As of September 30, | (Yrs) | Value | Amortization | Value | Amortization | |||||||||||||||
Core products and cell lines |
15 | $ | 4,698 | $ | 2,313 | $ | 4,698 | $ | 2,023 | |||||||||||
Manufacturing technologies |
15 | 5,907 | 4,089 | 5,907 | 3,743 | |||||||||||||||
Trademarks, licenses and patents |
12 | 2,270 | 1,694 | 2,005 | 1,545 | |||||||||||||||
Customer lists and supply
agreements |
13 | 10,641 | 5,963 | 10,633 | 5,116 | |||||||||||||||
$ | 23,516 | $ | 14,059 | $ | 23,243 | $ | 12,427 | |||||||||||||
The actual aggregate amortization expense for these intangible assets for fiscal 2007 was
$1,632,000. The aggregate amortization expense for these intangible assets for fiscal 2006 and
fiscal 2005 was $2,560,000 and $1,563,000, 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 2008 $1,478,000, fiscal 2009 $1,377,000,
fiscal 2010 $1,339,000, fiscal 2011- $1,266,000 and fiscal 2012 $1,121,000.
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 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
Program lowered the amount of materials to be supplied under the contract. During March 2007,
the Department informed Meridian that it would not be exercising the optional renewal period
from April 1, 2007 through March 31, 2008. Meridian does not expect to supply any more
materials under this contract, and as of September 30,
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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. | ||
(j) | 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 $2,415,000 at September 30, 2007 and $2,181,000 at September 30, 2006. | |
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 recognized upon delivery of product and acceptance by the customer. |
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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. | ||
(k) | Research and Development Costs - Research and development costs are charged to expense as incurred. Research and development costs include, among other things, salaries and wages for research scientists, materials and supplies used in the development of new products, and costs for facilities and equipment. | |
(l) | Income Taxes The provision for income taxes includes federal, foreign, state, and local income taxes currently payable and those deferred because of temporary differences between income for financial reporting and income for tax purposes. We prepare estimates of permanent and temporary differences between income for financial reporting purposes and income for 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 7. | |
(m) | Stock-based Compensation We account for stock-based compensation pursuant to SFAS No. 123R, Share-Based Payment, which was adopted as of July 1, 2005. SFAS No. 123R requires recognition of compensation expense for all share-based awards made to employees, based upon the fair value of the share-based award on the date of the grant. 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 and the non-vested portions of stock options awards granted prior to July 1, 2005. See Note 8(b). |
(n) | 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 6. |
(o) | Comprehensive Income (Loss) Comprehensive income represents the net change in shareholders equity during a period from sources other than transactions with shareholders. Meridians comprehensive income |
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is comprised of net earnings, foreign currency translation, and changes in the fair value of forward exchange contracts accounted for as cash flow hedges. Components of beginning and ending accumulated other comprehensive income (loss), and related activity, are shown in the following table (in thousands): |
Accumulated | ||||||||||||||||
Currency | Other | |||||||||||||||
Translation | Cash Flow | Tax | Comprehensive | |||||||||||||
Adjustment | Hedges | Benefits | Income (Loss) | |||||||||||||
Balance at September 30, 2006 |
$ | (153 | ) | $ | 13 | $ | 50 | $ | (90 | ) | ||||||
Currency translation |
981 | | | 981 | ||||||||||||
Reclassifications to earnings of hedging activity |
| 94 | 94 | |||||||||||||
Net unrealized losses on hedging instruments |
(377 | ) | (377 | ) | ||||||||||||
Tax benefits |
(244 | ) | (244 | ) | ||||||||||||
Balance at September 30, 2007 |
$ | 828 | $ | (270 | ) | $ | (194 | ) | $ | 364 | ||||||
(p) | Supplemental Cash flow Information Supplemental cash flow information is as follows for fiscal 2007 , 2006 and 2005 (dollars in thousands): |
Year Ended September 30, | 2007 | 2006 | 2005 | |||||||||
Cash paid for - |
||||||||||||
Income taxes |
$ | 12,412 | $ | 6,734 | $ | 7,067 | ||||||
Interest |
37 | 106 | 493 | |||||||||
Non-cash items - |
||||||||||||
Debenture conversions |
1,775 | 648 | 11,737 | |||||||||
(q) | Recent Accounting Pronouncements During July 2006, the Financial Accounting Standards Board issued Interpretation 48, Accounting for Uncertainty in Income Taxes: An Interpretation of FASB Statement No. 109. Interpretation 48 establishes criteria that an individual tax position would have to meet for some or all of the benefit of that position to be recognized in an entitys financial statements. Interpretation 48 also establishes disclosure criteria for tax contingency reserves. We will be required to adopt Interpretation 48 during the first quarter of fiscal 2008. At this time, we are unable to determine the impact that adoption of this pronouncement will have on our financial condition. |
During September 2006, the FASB issued SFAS No. 157, Fair Value Measurements. SFAS 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 157 in fiscal 2009. We are currently in the process of evaluating the impact of SFAS 157 on our financial statements. |
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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 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 159 in fiscal 2009. We are currently in the process of evaluating the impact of SFAS 157 on our financial statements. |
(r) | 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. |
(s) | 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. |
(t) | Reclassifications Certain reclassifications have been made to the prior year financial statements to conform to the current year presentation. |
(2) | OEM Concepts Acquisition |
On January 31, 2005, we acquired all of the outstanding common shares of OEM Concepts, Inc. for
$6,590,000 in cash, including transaction costs. OEM Concepts is a leading producer and
distributor of highly specialized biologicals for the diagnostic, pharmaceutical, and research
markets. The purchase agreement provides for additional consideration, up to a maximum remaining
amount of $1,819,000, contingent upon future calendar-year sales and gross profit of OEM Concepts
products through December 31, 2008. Earnout consideration, if any, is payable each year, following
the period earned. Earnout consideration in the amount of $118,000 related to calendar 2006 was
paid during fiscal 2007. Earnout consideration in the amount of $152,000 related to the nine-month
period ended September 30, 2007 has been accrued in the accompanying consolidated balance sheet.
The initial $6,590,000 purchase price and transaction costs were funded with bank debt under our
bank credit facility and cash on hand.
The acquisition was accounted for as a purchase, and the results of operations of OEM Concepts are
included in our consolidated results of operations from February 1, 2005 forward. A summary of the
purchase price allocation follows. This purchase price allocation reflects the fair values of
acquired long-lived assets, including supply agreements for $3,466,000 (see Note 1(i) regarding
impairment of one of these supply agreements), cell lines for $1,499,000, and customer
relationships for $562,000. The estimated fair market value of intangibles acquired was based on
discounted future cash flows. Intangible assets other than supply agreements and goodwill have an
estimated useful life of 15 years. Supply agreements have useful lives based on the terms of
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the agreements, between 3 and 10 years. Future earnout payment consideration, if any, will be
allocated to goodwill, and will be recorded in the period in which it is earned and becomes
payable.
Acquisition details are as follows (dollars in thousands):
Purchase price, including transaction costs and
earnout payments made |
$ | 7,056 | ||
Fair value of assets acquired - |
||||
Cash |
$ | 207 | ||
Accounts receivable |
505 | |||
Inventory |
643 | |||
Prepaid expenses |
47 | |||
Property, plant and equipment, net |
145 | |||
Specific intangibles |
5,527 | |||
Goodwill |
2,709 | |||
Other assets |
9 | |||
9,792 | ||||
Fair value of liabilities assumed - |
||||
Debt and capital lease obligations |
233 | |||
Deferred income tax liabilities |
2,062 | |||
Other liabilities |
441 | |||
2,736 | ||||
Fair value of net assets acquired |
$ | 7,056 | ||
(3) Inventories
Inventories are comprised of the following (dollars in thousands):
As of September 30, | 2007 | 2006 | ||||||
Raw materials |
$ | 4,816 | $ | 4,024 | ||||
Work-in-process |
5,141 | 4,578 | ||||||
Finished goods |
8,214 | 8,387 | ||||||
$ | 18,171 | $ | 16,989 | |||||
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(4) 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, 2007
or September 30, 2006. Available borrowings under this credit facility were $30,000,000 at
September 30, 2007. In connection with this bank credit arrangement, we are required to comply
with financial covenants that limit the amount of debt obligations, 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.
(5) Long-Term Debt Obligations
As of September 30, 2007, we have no debt obligations outstanding. As of September 30, 2006, we
had outstanding $1,803,000 principal of 5% debentures, convertible, at the option of the holder,
into common shares at a price of $6.45. During the first two quarters of fiscal 2007, $1,775,000
principal amount of these debentures were converted by the holders into 274,315 common shares.
During the second quarter of fiscal 2007, we redeemed the remaining $28,000 principal amount of
these debentures at a 1% premium. Deferred debenture issuance costs
of $101,000 were recorded to
additional paid-in capital in the accompanying consolidated balance sheet in connection with the
conversion transactions.
(6) Hedging Transactions
We have historically entered into forward exchange contracts to hedge cash flows from intercompany
sales between our US parent company and its Italian affiliate. These forward exchange contracts
are designated as cash flow hedges under SFAS No. 133. The following table presents our hedging
portfolio as of September 30, 2007 (amounts in thousands).
Notional | Contract | Estimated Fair | Average | |||||||||||||||||
Amount | Value | Value | Exchange Rate | Maturity | ||||||||||||||||
| 4,200 | $ | 5,756 | $ | 6,003 | 1.3703 | FY 2008 | |||||||||||||
| 300 | $ | 421 | $ | 429 | 1.4021 | FY 2009 | |||||||||||||
At September 30, 2007, unrealized losses of $270,000 were included in accumulated other
comprehensive income in the consolidated balance sheet. This amount is expected to be reclassified
into net earnings within the next 15 months. The estimated fair value of forward contracts
outstanding at September 30, 2007 is based on quoted amounts provided by the counterparty to these
contracts.
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(7) Income Taxes
(a) Earnings before income taxes, and the related provision for income taxes for the years ended
September 30, 2007, 2006 and 2005 were as follows (dollars in thousands):
Year Ended September 30, | 2007 | 2006 | 2005 | |||||||||
Earnings before income taxes - |
||||||||||||
Domestic |
$ | 33,324 | $ | 25,365 | $ | 17,640 | ||||||
Foreign |
3,358 | 2,701 | 2,065 | |||||||||
Total |
$ | 36,682 | $ | 28,066 | $ | 19,705 | ||||||
Provision (credit) for income taxes - |
||||||||||||
Federal |
||||||||||||
Current provision |
$ | 11,179 | $ | 8,902 | $ | 6,550 | ||||||
Temporary differences |
||||||||||||
Fixed asset basis differences and depreciation |
(105 | ) | (65 | ) | (57 | ) | ||||||
Intangible asset basis differences and amortization |
(249 | ) | (588 | ) | (227 | ) | ||||||
Currently non-deductible expenses and reserves |
238 | (88 | ) | (467 | ) | |||||||
Stock based compensation |
(678 | ) | (339 | ) | (65 | ) | ||||||
Other, net |
(258 | ) | 2 | (163 | ) | |||||||
Tax contingency reserve adjustment |
(2,425 | ) | | | ||||||||
Subtotal |
7,702 | 7,824 | 5,571 | |||||||||
State and local |
1,250 | 814 | 600 | |||||||||
Foreign |
1,009 | 1,095 | 896 | |||||||||
Total |
$ | 9,961 | $ | 9,733 | $ | 7,067 | ||||||
(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, | 2007 | 2006 | 2005 | |||||||||||||||||||||
Computed income taxes at statutory rate |
$ | 12,839 | 35.0 | % | $ | 9,824 | 35.0 | % | $ | 6,895 | 35.0 | % | ||||||||||||
Increase (decrease) in taxes resulting from - |
||||||||||||||||||||||||
State and local income taxes |
835 | 2.3 | 685 | 2.4 | 500 | 2.5 | ||||||||||||||||||
Federal and state tax credits |
(213 | ) | (0.6 | ) | (88 | ) | (0.3 | ) | (166 | ) | (0.8 | ) | ||||||||||||
Subpart F income taxes |
| | | | 117 | 0.6 | ||||||||||||||||||
Foreign tax rate differences |
170 | 0.5 | 145 | 0.5 | 19 | 0.1 | ||||||||||||||||||
Valuation allowance reversal France |
(309 | ) | (0.8 | ) | | | | | ||||||||||||||||
Extra territorial income exclusion |
(56 | ) | (0.2 | ) | (275 | ) | (1.0 | ) | (306 | ) | (1.6 | ) | ||||||||||||
Qualified domestic production incentives |
(290 | ) | (0.8 | ) | (236 | ) | (0.8 | ) | | | ||||||||||||||
Tax exempt interest |
(418 | ) | (1.1 | ) | (281 | ) | (1.0 | ) | | | ||||||||||||||
Tax contingency reserve adjustment |
(2,425 | ) | (6.6 | ) | | | | | ||||||||||||||||
Other, net |
(172 | ) | (0.5 | ) | (41 | ) | (0.1 | ) | 8 | 0.1 | ||||||||||||||
$ | 9,961 | 27.2 | % | $ | 9,733 | 34.7 | % | $ | 7,067 | 35.9 | % | |||||||||||||
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(c) The components of net deferred tax liabilities were as follows (dollars in thousands):
As of September 30, | 2007 | 2006 | ||||||
Deferred tax assets - |
||||||||
Valuation reserves and non-deductible expenses |
$ | 922 | $ | 1,465 | ||||
Stock compensation expense not deductible |
1,237 | 503 | ||||||
Net operating loss carryforwards |
920 | 890 | ||||||
Inventory basis differences |
472 | 176 | ||||||
Other |
90 | 225 | ||||||
Subtotal |
3,641 | 3,259 | ||||||
Less valuation allowance |
(569 | ) | (888 | ) | ||||
Deferred tax assets |
3,072 | 2,371 | ||||||
Deferred tax liabilities - |
||||||||
Fixed asset basis differences and depreciation |
(711 | ) | (830 | ) | ||||
Intangible asset basis differences and amortization |
(2,918 | ) | (3,190 | ) | ||||
Other |
(750 | ) | (458 | ) | ||||
Deferred tax liabilities |
(4,379 | ) | (4,478 | ) | ||||
Net deferred tax liabilities |
$ | (1,307 | ) | $ | (2,107 | ) | ||
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 in
the amount of $569,000 for the country of Belgium at September 30, 2007. 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, 2006 was $888,000 and related
solely to net operating loss carryforwards in Belgium and France.
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.
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Undistributed earnings re-invested indefinitely in the Italian operation were approximately
$13,900,000 at September 30, 2007. US deferred tax liabilities of approximately $5,300,000 on such
earnings have not been
recorded. Management believes that such US taxes would be largely offset by foreign tax credits
for taxes paid in Italy.
On June 30, 2005, Ohios governor signed Biennial Budget Bill, Am. Sub. H.B. 66. This bill
replaced Ohios corporate income and personal property taxes with a commercial activity tax based
on gross receipts, phased in over five years beginning July 1, 2005. We have evaluated the impact
of this legislation on our deferred tax balances. The carrying value of deferred taxes was not
materially affected by the enactment of this legislation.
From time to time, our tax returns in Federal, state, and foreign jurisdictions are examined by the
applicable tax authorities. Our tax provisions take into consideration the judgmental nature of
certain tax positions through the establishment of reserves for differences between the probable
tax determinations and the as filed tax positions of certain assets and liabilities. 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.
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.
(8) 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 compensation. Our discretionary and matching contributions to the plan amounted to approximately $1,132,000, $1,066,000, and $1,006,000, during fiscal 2007, 2006 and 2005, 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. |
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We may grant new shares for options for up to 1,462,500 shares under the 2004 Plan, of which we have granted 976,000 through September 30, 2007. 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. | ||
We adopted SFAS No. 123(R), Share-Based Payment, 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. | ||
Prior to July 1, 2005, we accounted for our stock based compensation plans pursuant to the intrinsic value method in APB No. 25. Had compensation cost for these plans been determined using the fair value method provided in SFAS No. 123(R), our net earnings for fiscal 2005 would have been $12,376,000, compared to a reported amount of $12,638,000. Basic earnings per share for fiscal 2005 would have been $0.35, compared to a reported amount of $0.36. Diluted earnings per share for fiscal 2005 would have been $0.34, compared to a reported amount of $0.35. | ||
The amount of stock-based compensation expense reported was $2,632,000, $1,082,000 and $279,000 in fiscal 2007, fiscal 2006, and fiscal 2005, respectively. The total income tax benefit recognized in the income statement for these stock-based compensation arrangements was $668,000, $339,000, and $65,000, for fiscal 2007, fiscal 2006, and fiscal 2005, respectively. We expect stock compensation expense for unvested options as of September 30, 2007 to be $1,565,000, which will be recognized during fiscal years 2008 through 2011. | ||
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 2007, we recorded $210,000 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 for fiscal 2007 and 2006: (i) expected share price volatility based on implied volatility calculations using options for Meridian and a peer-group of companies; (ii) expected life of |
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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, | 2007 | 2006 | 2005 | |||||||||
Risk-free interest rates |
4.64 | % | 4.3%-4.4 | % | 3.8%-4.3 | % | ||||||
Dividend yield |
1.96 | % | 1.55 | % | 2.3%-5.4 | % | ||||||
Life of option |
5.80-7.50 yrs. | 5.70-7.50 yrs. | 6.25-7.00 yrs. | |||||||||
Share price volatility |
44 | % | 46 | % | 52%-54 | % | ||||||
Forfeitures (by employee group) |
0%-20 | % | 0%-20 | % | 5%-38 | % | ||||||
A summary of the status of our stock option plans at September 30, 2007 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 |
1,919,696 | $ | 5.48 | |||||||||||||
Grants |
358,925 | 16.65 | ||||||||||||||
Exercises |
(336,433 | ) | 3.91 | |||||||||||||
Forfeitures |
(9,256 | ) | 13.14 | |||||||||||||
Cancellations |
(1,048 | ) | 6.11 | |||||||||||||
Outstanding end of period |
1,931,884 | $ | 7.79 | 5.9 | $ | 43,524,000 | ||||||||||
Exercisable end of period |
647,520 | $ | 4.80 | 4.1 | $ | 16,524,000 | ||||||||||
A summary of the status of our nonvested shares as of September 30, 2007, and changes during the
year ended September 30, 2007, is presented below:
Weighted- | ||||||||
Average Grant | ||||||||
Date Fair | ||||||||
Shares | Value | |||||||
Nonvested beginning of period |
1,151,595 | $ | 2.93 | |||||
Granted |
358,925 | 7.10 | ||||||
Vested |
(216,900 | ) | 3.34 | |||||
Forfeited |
(9,256 | ) | 5.74 | |||||
Nonvested end of period |
1,284,364 | $ | 4.03 | |||||
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The weighted average grant-date fair value of options granted was $7.10, $6.54, and $3.21 for fiscal 2007, 2006, and 2005, respectively. The total intrinsic value of options exercised was $5,526,000, $2,648,000 and $3,659,000, for fiscal 2007, fiscal 2006, and 2005, respectively. The total grant-date fair value of options that vested during fiscal 2007, 2006, and 2005 was $721,000, $296,000 and $235,000, respectively. | ||
Cash received from options exercised was $1,315,000, $990,000, and $3,302,000 for fiscal 2007, 2006, and 2005, respectively. Tax benefits realized and recorded to additional paid-in capital from option exercises totaled $1,632,000, $732,000, and $654,000 for fiscal 2007, 2006, and 2005 respectively. |
(9) 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 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, | 2007 | 2006 | 2005 | |||||||||||||||||||||
Customer A (US Diagnostics) |
$ | 24,678 | (20 | %) | $ | 20,014 | (18 | %) | $ | 15,512 | (17 | %) | ||||||||||||
Customer B (US Diagnostics) |
$ | 13,340 | (11 | %) | $ | 10,989 | (10 | %) | $ | 8,244 | (9 | %) | ||||||||||||
Combined export sales for the US Diagnostics and Life Science operating segments were $15,128,000,
$14,728,000 and $12,414,000 in fiscal years 2007, 2006 and 2005, respectively. Three products
accounted for 31%, 28%, and 23% of consolidated net sales in fiscal 2007, fiscal 2006, and fiscal
2005, respectively.
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Approximately 30% of the consolidated accounts receivable balance at September
30, 2007 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, | 2007 | 2006 | 2005 | |||||||||
Italy |
$ | 7,838 | $ | 6,840 | $ | 6,221 | ||||||
France |
3,070 | 2,387 | 2,365 | |||||||||
United Kingdom |
1,987 | 1,571 | 1,454 | |||||||||
Holland |
1,610 | 1,372 | 1,125 | |||||||||
Belgium |
1,558 | 1,504 | 1,303 | |||||||||
Other |
7,500 | 6,154 | 5,350 | |||||||||
Total European Operating Segment |
$ | 23,563 | $ | 19,828 | $ | 17,818 | ||||||
Identifiable assets for our Italian distribution organization were $12,811,000, $11,397,000, and
$9,430,000 at September 30, 2007, 2006 and 2005, respectively.
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Segment information for the years ended September 30, 2007, 2006, and 2005 is as follows (dollars
in thousands):
US | European | Life | ||||||||||||||||||
Diagnostics | Diagnostics | Science | Elim (1) | Total | ||||||||||||||||
Fiscal Year 2007 - |
||||||||||||||||||||
Net sales |
||||||||||||||||||||
Third-party |
$ | 74,845 | $ | 23,563 | $ | 24,555 | $ | | $ | 122,963 | ||||||||||
Inter-segment |
8,872 | | 532 | (9,404 | ) | | ||||||||||||||
Operating income |
26,825 | 4,559 | 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 |
20,169 | 3,540 | 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 | ||||||||||||||
Fiscal Year 2005 - |
||||||||||||||||||||
Net sales |
||||||||||||||||||||
Third-party |
$ | 53,485 | $ | 17,818 | $ | 21,662 | $ | | $ | 92,965 | ||||||||||
Inter-segment |
6,553 | 15 | 804 | (7,372 | ) | | ||||||||||||||
Operating income |
13,655 | 2,315 | 4,251 | 104 | 20,325 | |||||||||||||||
Depreciation and amortization |
2,667 | 147 | 1,438 | | 4,252 | |||||||||||||||
Capital expenditures |
1,477 | 89 | 1,024 | | 2,590 | |||||||||||||||
Total assets |
99,878 | 11,552 | 38,947 | (40,243 | ) | 110,134 | ||||||||||||||
(1) | Eliminations consist of intersegment transactions. |
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Year Ended September 30, | 2007 | 2006 | 2005 | |||||||||
Segment operating income |
$ | 35,030 | $ | 26,894 | $ | 20,325 | ||||||
Interest income |
1,642 | 1,123 | 43 | |||||||||
Interest expense |
(38 | ) | (128 | ) | (770 | ) | ||||||
Other, net |
48 | 177 | 107 | |||||||||
Consolidated earnings before income taxes |
$ | 36,682 | $ | 28,066 | $ | 19,705 | ||||||
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 $1,492,000 and $8,472,000, respectively at September 30,
2007, $1,578,000 and $8,286,000, respectively at September 30, 2006, and $1,612,000 and $7,167,000,
respectively at September 30, 2005.
(10) 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 $739,000, $866,000, and $743,000, respectively, for the fiscal years ended September 30, 2007, 2006 and 2005. | |
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 $1,740,000) 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 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. |
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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. | ||
(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 $9,305,000 and $385,000 for fiscal 2008 and fiscal 2009, respectively. No commitments have been made for fiscal 2010, 2011, or 2012. | |
(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 $696,000, $686,000 and $621,000 for fiscal 2007, 2006 and 2005, respectively. Operating lease commitments for each of the five succeeding fiscal years are as follows: fiscal 2008 - $599,000, fiscal 2009 $464,000, fiscal 2010 $260,000, fiscal 2011 $98,000, and fiscal 2012 $95,000. | |
(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 may 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, 2007 and September 30, 2006. 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 $1,819,000 at September 30, 2007, contingent upon future calendar year sales and gross profit of OEM Concepts products through December 31, 2008. Earnout consideration in the amount of $118,000 related to calendar 2006 was paid during fiscal 2007. Earnout consideration in the amount of $152,000 related to the nine-month period ended September 30, 2007 has been accrued in the accompanying consolidated balance sheet. Future earnout consideration, if any, will be allocated to goodwill, and will be recorded in the period in which it is earned and payable. |
(11) Quarterly Financial Data (Unaudited)
All quarters of fiscal 2007 and fiscal 2006 have been adjusted to reflect the change in accounting for certain inventories within the Life Science operating segment from the LIFO method to the FIFO method. See further detail regarding this change in Note 1(g). | ||
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 | September | |||||||||||||||||||||||||||
2007 | December 31 | March 31 | June 30 | 30 | ||||||||||||||||||||||||
As | As | As | ||||||||||||||||||||||||||
Previously | As | Previously | As | Previously | As | |||||||||||||||||||||||
Reported | Adjusted | Reported | Adjusted | Reported | Adjusted | |||||||||||||||||||||||
Net sales |
$ | 28,720 | $ | 28,720 | $ | 32,094 | $ | 32,094 | $ | 29,763 | $ | 29,763 | $ | 32,386 | ||||||||||||||
Gross profit |
17,597 | 17,612 | 18,823 | 18,838 | 19,286 | 19,301 | 19,189 | |||||||||||||||||||||
Net earnings |
5,564 | 5,573 | 5,881 | 5,890 | 8,804 | 8,814 | 6,444 | |||||||||||||||||||||
Basic earnings per common share |
0.14 | 0.14 | 0.15 | 0.15 | 0.22 | 0.22 | 0.16 | |||||||||||||||||||||
Diluted earnings per common
share |
0.14 | 0.14 | 0.15 | 0.15 | 0.22 | 0.22 | 0.16 | |||||||||||||||||||||
Cash dividends per common share |
0.08 | 0.08 | 0.11 | 0.11 | 0.11 | 0.11 | 0.11 |
For the Quarter Ended in Fiscal | ||||||||||||||||||||||||||||||||
2006 | December 31 | March 31 | June 30 | September 30 | ||||||||||||||||||||||||||||
As | As | As | As | |||||||||||||||||||||||||||||
Previously | As | Previously | As | Previously | As | Previously | As | |||||||||||||||||||||||||
Reported | Adjusted | Reported | Adjusted | Reported | Adjusted | Reported | Adjusted | |||||||||||||||||||||||||
Net sales |
$ | 24,908 | $ | 24,908 | $ | 28,272 | $ | 28,272 | $ | 26,583 | $ | 26,583 | $ | 28,650 | $ | 28,650 | ||||||||||||||||
Gross profit |
15,150 | 15,150 | 16,580 | 16,640 | 16,355 | 16,385 | 16,586 | 16,509 | ||||||||||||||||||||||||
Net earnings |
3,962 | 3,962 | 4,723 | 4,760 | 4,862 | 4,881 | 4,778 | 4,730 | ||||||||||||||||||||||||
Basic earnings per common share |
0.10 | 0.10 | 0.12 | 0.12 | 0.12 | 0.12 | 0.12 | 0.12 | ||||||||||||||||||||||||
Diluted earnings per common
share |
0.10 | 0.10 | 0.12 | 0.12 | 0.12 | 0.12 | 0.12 | 0.12 | ||||||||||||||||||||||||
Cash dividends per common share |
0.05 | 0.05 | 0.08 | 0.08 | 0.08 | 0.08 | 0.08 | 0.08 |
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(12) Public Offering of Common Shares and Stock Split
On September 21, 2005, we issued 2,700,000 common shares at an offering price of $11.67 per share. The number of shares issued and the offering price per share have been adjusted to reflect the May 2007 stock split discussed below. The net proceeds from the offering, after underwriting discounts and offering costs totaling $1,920,000, were approximately $29,580,000. Underwriting discounts and offering costs incurred in connection with this offering are reflected as a reduction of shareholders equity. | ||
On August 15, 2005, we announced a three-for-two stock split, with fractional shares paid in cash. This split was effective on September 2, 2005 to shareholders of record as of August 29, 2005. 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 these stock splits. |
ITEM 9.
CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS
ON ACCOUNTING AND FINANCIAL DISCLOSURE
ON ACCOUNTING AND FINANCIAL DISCLOSURE
Nothing to report.
ITEM 9A.
CONTROLS AND PROCEDURES
As of September 30, 2007, 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, 2007. 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, 2007, other than we
implemented, as planned, new enterprise resource planning and general ledger and financial
reporting systems for our Life Science facilities during the first quarter of fiscal 2008. These
new system implementations provide the appropriate foundation to support future growth in our Life
Science operating segment.
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.
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ITEM 9B.
OTHER INFORMATION
Nothing to report.
PART III
The information required by Items 10., 11., 12., 13., and 14., of Part III are incorporated by
reference from the Registrants Proxy Statement for its 2008 Annual Shareholders Meeting to be
filed with the Commission pursuant to Regulation 14A.
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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 | Filing Status | ||
3.1
|
Articles of Incorporation, including amendments not related to Company name change | A | ||
3.2
|
Code of Regulations | B | ||
10.5
|
Sublicense Agreement dated June 17, 1993 among Johnson & Johnson, the Scripps Research Institute and Meridian Concerning certain Patent Rights | E | ||
10.6
|
Assignment dated June 17, 1993 from Ortho Diagnostic Systems Inc. to Meridian concerning certain Patent Rights | E | ||
10.7
|
Agreement dated January 24, 1994 between Meridian Diagnostics, Inc. and Immulok, Inc. | F | ||
10.8
|
Asset Purchase Agreement dated June 24, 1996 between Cambridge Biotech Corporation and Meridian Diagnostics, Inc. | G | ||
10.9
|
Merger Agreement among Gull Laboratories, Inc., Meridian Diagnostics, Inc. Fresenius AG and Meridian Acquisition Co. dated as of September 15, 1998 | H | ||
10.10*
|
Savings and Investment Plan Prototype Adoption Agreement | S | ||
10.14*
|
1994 Directors Stock Option Plan | J | ||
10.15*
|
1996 Stock Option Plan | K | ||
10.16*
|
Salary Continuation Agreement for John A. Kraeutler | L | ||
10.17
|
First Amendment to Merger Agreement Among Gull Laboratories, Inc., Meridian Diagnostics, Inc. Fresenius AG and Meridian Acquisition Co. | M |
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Exhibit Number | Description of Exhibit | Filing Status | ||||
10.18*
|
1999 Directors Stock Option Plan | N | ||||
10.20
|
Dividend Reinvestment Plan | P | ||||
10.21
|
Merger Agreement dated September 13, 2000 among Meridian and the Shareholders of Viral Antigens, Inc. | O | ||||
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 | R | ||||
10.24*
|
Sample Option Agreement Dated October 1, 2001 | R | ||||
10.26*
|
1996 Stock Option Plan as Amended and Restated Effective January 23, 2001 | Q | ||||
10.27*
|
Sample Option Agreement Dated November 19, 2002 | S | ||||
10.28*
|
Agreement Concerning Disability and Death dated September 10, 2003, between Meridian and William J. Motto | S | ||||
10.29*
|
Professional Services Agreement dated October 1, 2002 between Meridian and Antonio Interno | S | ||||
10.31
|
Stock Purchase Agreement of OEM Concepts, Inc. by Meridian Bioscience, Inc. dated January 31, 2005 | W | ||||
10.32*
|
Sample Option Agreement dated November 10, 2005 | W | ||||
10.33*
|
2004 Equity Compensation Plan, Amended and Restated through January 19, 2006 | V | ||||
10.34*
|
Fiscal 2006 Officers Compensation Plan, Amended and Restated through January 19, 2006 | V | ||||
10.35*
|
Sample Option Agreement dated November 14, 2007 | Filed herewith | ||||
10.36*
|
Fiscal 2007 Officers Performance Compensation Plan | X | ||||
10.37
|
Amended and Restated Revolving Note with Fifth Third Bank dated August 1, 2007 | Filed herewith | ||||
13
|
2008 Annual Report to Shareholders | (1 | ) | |||
14
|
Code of Ethics | S | ||||
18
|
Grant Thornton Preferability Letter | Filed herewith |
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Exhibit Number | Description of Exhibit | Filing Status | ||||
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 | ||||
32
|
Section 1350 Certification of Chief Executive Officer and Chief Financial Officer | Filed herewith |
(1) | Only portions of the 2007 Annual Report to Shareholders specifically are incorporated by reference in this Form 10-K as filed herewith. A supplemental paper copy of the 2007 Annual Report to Shareholders has been provided to the Securities and Exchange Commission for informational purposes only. | |
* | Management Compensatory Contracts |
Incorporated by reference to:
A. | Registration Statement No. 333-02613 on Form S-3 filed with the Securities and Exchange Commission on April 18, 1996. | |
B. | Registration Statement No. 33-6052 filed under the Securities Act of 1933. | |
C. | Registration Statement No. 333-11077 on Form S-3 filed with the Securities and Exchange Commission on August 29, 1996. | |
D. | Meridians Schedule T-O filed with the Securities and Exchange Commission on October 24, 2003. | |
E. | Meridians Form 8-K filed with the Securities and Exchange Commission on June 17, 1993. | |
F. | Meridians Forms 8-K filed with the Securities and Exchange Commission on February 8, 1994 and April 6, 1994. | |
G. | Meridians Form 8-K filed with the Securities and Exchange Commission on July 2, 1996. | |
H. | Meridians Form 8-K filed with the Securities and Exchange Commission on September 17, 1998. | |
I. | Not used. | |
J. | Registration Statement No. 33-78868 on Form S-8 filed with the Securities and Exchange Commission on May 12, 1994. | |
K. | Meridians Annual Report on Form 10-K for the Fiscal Year Ended September 30, 1996. | |
L. | Meridians Annual Report on Form 10-K for the Fiscal Year Ended September 30, 1995. | |
M. | Companys Report on Form 8-K filed with the Securities and Exchange Commission filed on November 13, 1998. | |
N. | Meridians Proxy Statement filed with the Securities and Exchange Commission on December 21, 1998. | |
O. | Meridians Current Report on Form 8-K dated September 29, 2000. |
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P. | Meridians Annual Report on Form 10-K for the Fiscal Year Ended September 30, 1999. | |
Q. | Registration Statement No. 333-75312 on Form S-8 filed with the Securities and Exchange Commission on December 17, 2001 | |
R. | Meridians Annual Report on Form 10-K for the Fiscal Year Ended September 30, 2001. | |
S. | Meridians Annual Report on Form 10-K for the Fiscal Year Ended September 30, 2003. | |
T. | Meridians Annual Report on Form 10-K for the Fiscal Year Ended September 30, 2004. | |
U. | Meridians Proxy Statement filed with the Securities and Exchange Commission on December 23, 2004. | |
V. | Meridians Form 8-K dated January 19, 2006. | |
W. | Meridians Annual Report on Form 10-K for the Fiscal Year Ended September 30, 2005. | |
X. | Meridians Form 8-K filed November 21, 2006 |
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/ William J. Motto | |||
Date: November 30, 2007 | William J. Motto | |||
Chairman of the Board and Chief Executive Officer |
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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 and Chief Executive Officer (Principal Executive Officer) | November 30, 2007 | ||
/s/ John A. Kraeutler
|
President and Chief Operating Officer, Director | November 30, 2007 | ||
/s/ Melissa Lueke
|
Vice President and Chief Financial Officer | November 30, 2007 | ||
/s/ James A. Buzard
|
Director | November 30, 2007 | ||
/s/ Gary P. Kreider
|
Director | November 30, 2007 | ||
/s/ David C. Phillips
|
Director | November 30, 2007 | ||
/s/ Robert J. Ready
|
Director | November 30, 2007 |
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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, 2007, 2006 and 2005
(Dollars in thousands)
Years Ended September 30, 2007, 2006 and 2005
Charged | ||||||||||||||||||||
Balance at | to Costs | Balance | ||||||||||||||||||
Beginning | and | at End of | ||||||||||||||||||
Description | of Period | Expenses | Deductions | Other (a) | Period | |||||||||||||||
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 | |||||||||||||
Year Ended September 30, 2005: |
||||||||||||||||||||
Allowance for doubtful accounts |
$ | 479 | $ | (37 | ) | $ | (88 | ) | $ | 6 | $ | 360 | ||||||||
Inventory realizability reserves |
271 | 494 | (369 | ) | 160 | 556 | ||||||||||||||
Valuation allowances deferred taxes |
1,177 | | (223 | ) | (27 | ) | 927 |
(a) | Balances reflect the effects of currency translation (fiscal years 2005-2007) and the acquisition of OEM Concepts January 31, 2005 (fiscal year 2005). |
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