Form 10-K
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
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ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
FOR THE FISCAL YEAR ENDED SEPTEMBER 30, 2009.
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
FOR THE TRANSITION PERIOD FROM TO
Commission File No. 0-14902
MERIDIAN BIOSCIENCE, INC.
3471 River Hills Drive
Cincinnati, Ohio 45244
IRS Employer ID No. 31-0888197
Incorporated under the Laws of Ohio
Phone: (513) 271-3700
Securities Registered Pursuant to Section 12(b) of the Act:
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Title of each class
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Name of each exchange of which registered |
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Common Shares, No Par Value
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The NASDAQ Stock Market LLC |
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(NASDAQ Global Select Market) |
Securities Registered Pursuant to Section 12(g) of the Act:
None
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in
Rule 405 of the Securities Act.
YES þ NO o
If this report is an annual or transition report, indicate by check mark if the registrant
is not required to file reports pursuant to Section 13 or 15(d) of the Securities Exchange
Act.
YES o NO þ
Indicate by check mark whether the registrant: (1) has filed all reports required to be
filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding
12 months, and (2) has been subject to such filing requirements for the past 90 days.
YES þ NO o
Indicate by check mark whether the registrant has submitted electronically and posted on
its corporate Web site, if any, every Interactive Data File required to be submitted and
posted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such
shorter period that the registrant was required to submit and post such files).
YES o NO o
Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of
Regulation S-K (Section 229.405 of this Chapter) is not contained herein, and will
not be contained, to the best of registrants knowledge, in definitive proxy or
information statements incorporated by reference in Part III of this Form 10-K or
any amendment to this Form 10-K.
YES o NO þ
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated
filer, a non-accelerated filer, or a smaller reporting company. See definitions of large
accelerated filer, accelerated filer and smaller reporting company in Rule 12b-2 of
the Exchange Act.
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Large accelerated filer þ
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Non-accelerated filer o
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(Do not check if a smaller reporting company) |
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Indicate by check mark whether the registrant is a shell company (as defined in Exchange Act Rule 12b-2).
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The aggregate market value of Common Shares held by non-affiliates as of March 31, 2009
was $714,090,011 based on a closing sale price of $18.12 per share on March 31, 2009. As
of October 31, 2009, 40,571,220 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, 2009 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 2010 Annual
Shareholders Meeting are incorporated by reference in Part III as specified.
MERIDIAN BIOSCIENCE, INC.
INDEX TO ANNUAL REPORT
ON FORM 10-K
FORWARD LOOKING STATEMENTS
The Private Securities Litigation Reform Act of 1995 provides a safe harbor from civil litigation
for forward-looking statements accompanied by meaningful cautionary statements. Except for
historical information, this report contains forward-looking statements within the meaning of
Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange
Act of 1934, which may be identified by words such as 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 or revise any
forward-looking statements even if experience or future changes make it clear that any projected
results expressed or implied therein will not be realized. These statements are subject to various
risks, uncertainties and other factors that could cause actual results to differ materially,
including, without limitation, the following: 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. Recessionary pressures on the
economy and the markets in which our customers operate, as well as adverse trends in buying
patterns from customers can change expected results. Costs and difficulties in complying with laws
and regulations 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 U.S. dollar can also 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. The
Company cannot predict the possible effects of potential healthcare reform in the United States and
similar initiatives in other countries on its results of operations. In addition to the factors
described in this paragraph, Part I, Item 1A Risk Factors contains a list and description of
uncertainties, risks and other matters that may affect the Company.
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.
In the discussion that follows, all amounts are in thousands (both tables and text), except per
share and employee data and square footage and acreage data related to properties.
ITEM 1.
BUSINESS
Overview
Meridian is a fully-integrated life science company whose principal businesses are (i) the
development, manufacture, sale and distribution of diagnostic test kits, primarily for certain
respiratory, gastrointestinal, viral and parasitic infectious diseases, (ii) the manufacture and
distribution of bulk antigens, antibodies, and reagents used by researchers and other diagnostic
manufacturers and (iii) the contract development and manufacture of proteins and other biologicals
for use by biopharmaceutical and biotechnology companies engaged in research for new drugs and
vaccines. By exploiting revenue opportunities across research, clinical diagnostics, and
therapeutics, we strive to maximize revenues, efficiently invest in research and development, and
increase profitability of our manufacturing operations. The company was incorporated in Ohio in
1976.
Operating Segments
Our reportable operating segments are US Diagnostics, European Diagnostics, and Life Science. The
US Diagnostics operating segment consists of manufacturing operations in Cincinnati, Ohio, and the
sale and distribution of 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. Financial information for
Meridians operating segments is included in Note 8 to the consolidated financial statements
contained herein.
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Our primary source of domestic and international revenues continues to be core diagnostic products,
which represented 84% of consolidated net sales for fiscal 2009. Our diagnostic products provide
accuracy, simplicity, and speed, enable early diagnosis and treatment of common, acute medical
conditions, and provide for better patient outcomes at reduced costs. We target diagnostics for
disease states that (i) are acute conditions where rapid diagnosis impacts patient outcomes, (ii)
have opportunistic demographic and disease profiles, (iii) are underserved by current diagnostic
products, and (iv) have difficult sample handling requirements. This approach has allowed us to
establish significant market share in our target disease states.
Our website is www.meridianbioscience.com. We make available our Annual Reports on Form 10-K,
Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and any amendments thereto, free of
charge through this website, as soon as reasonably practicable after such material has been
electronically filed with or furnished to the Securities and Exchange Commission. These reports
may also be read and copied at the SECs public reference room at 100 F Street, N.E., Room 1580,
Washington, DC 20549, phone 1-800-732-0330. The SEC maintains an internet site containing these
filings and other information regarding Meridian at http://www.sec.gov. The information on
our website is not part of this Annual Report on Form 10-K.
US Diagnostics Operating Segment
Overview
Our US Diagnostics operating segments business focuses on the development, manufacture, sale and
distribution of diagnostic test kits, primarily for certain respiratory, gastrointestinal, viral
and parasitic infectious diseases. In addition to diagnostic test kits, products also include
transport media that store and preserve specimen samples from patient collection to laboratory
testing. Third-party sales for this operating segment were $98,970, $88,419 and $74,845 for fiscal
2009, 2008 and 2007, respectively, reflecting a three-year compound annual growth rate of 15%. As
of September 30, 2009, our US Diagnostics operating segment had 275 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 and hospitals.
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 group purchasing organizations that have
reduced the number of institutional customers for diagnostic products and resulted in changes in
buying practices. Specifically, multi-year exclusive or primary source marketing or distribution
contracts with institutional customers have become more common, replacing less formal distribution
arrangements of shorter duration and involving lower product volumes.
Sales and Marketing
Our US Diagnostics operating segments sales and distribution network consists of a direct sales
force in the US and Canada and independent distributors in the US and abroad. The direct sales
force consists of three management personnel who oversee corporate health accounts and work with
managed-care institutions, and six management personnel who oversee 24 technical sales
representatives, three inside sales representatives, and independent distributors in over 25
countries.
Our only customers who accounted for 10% or more of consolidated sales in fiscal 2009, 2008 and
2007 were two independent distributors in the US for our US Diagnostics operating segment: Cardinal
Healthcare Corporation and Fisher Scientific. Our sales to Cardinal were $37,876, $31,285, and
$24,444 during fiscal 2009, fiscal 2008, and fiscal 2007, respectively. Our sales to Fisher were
$19,063, $16,160, and $13,340 during fiscal 2009, fiscal 2008, and fiscal 2007, respectively.
By design, we do
not have distribution agreements in place with these customers because we manage the selling efforts
for key end-users where these distributors are utilized.
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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 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
135 medical diagnostic products.
We had three products that accounted for 30%, 32%, and 31% of consolidated net sales in fiscal
2009, fiscal 2008, and fiscal 2007, respectively: ImmunoCard® Toxins A&B, PremierTM
Toxins A&B, and PremierTM Platinum HpSA® PLUS.
ImmunoCard® Toxins A&B and PremierTM Toxins A&B are part of our C. difficile
product family. ImmunoCard® Toxins A&B is a rapid enzyme immunoassay used for the
detection of C. difficile toxins A and B in stool specimens. PremierTM Toxins A&B is an
ELISA test in a batch microwell format for the detection of C. difficile toxins A and B in stool
specimens. Both of the products were internally developed and are manufactured in our Cincinnati,
Ohio facility. As members of our C. difficile product family relating to hospital-acquired
infections, both ImmunoCard® Toxins A&B and PremierTM Toxins A&B participate
in the organic growth of our Diagnostics business units, US Diagnostics and European Diagnostics.
PremierTM Platinum HpSA® PLUS is an ELISA test in a microwell format for the
detection of Heliobacter pylori antigens in stool specimens for diagnosis and monitoring and is a
part of our H. pylori family of products. This product was internally developed and is
manufactured in our Cincinnati, Ohio facility. We hold both US and European patents for this
product.
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Research and Development
Our US Diagnostics operating segments research and development organization consists of 26
research scientists with expertise in biochemistry, immunology, mycology, bacteriology, virology,
parasitology, and molecular biology. Research and development expenses for the US Diagnostics
operating segment for fiscal 2009, 2008 and 2007 were $7,209, $4,878 and $4,571, 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 35% of our US Diagnostics
operating segments third-party sales during fiscal 2009.
During fiscal 2008, we launched our first products under our recently developed and patented TRU
rapid test technology. The design of this technology enhances laboratory safety by containing the
specimen in a closed system during testing as recommended by CDC guidelines. TRU tests also use
less space than other technologies, which is an advantage in space-constrained clinical
laboratories. New products using this technology include TRU FLU®, TRU RSV®,
TRU EBV-M®, and TRU EBV-G®.
We also believe that the use of collaborative partners in the development of new products will
complement our internal research and development staff in a manner that allows us to bring products
to market more quickly than if development were to occur solely on an internal basis. During
August 2006, we entered into a partnership agreement with the Performance & Life Science Chemicals
Division of Merck KGaA, Darmstadt, Germany for the development of new clinical assays. Our first
product under this agreement, ImmunoCard STAT! ® EHEC, was launched during the second
quarter of fiscal 2007. We launched our second product in collaboration with Merck, ImmunoCard
STAT! ® CAMPY, during the third quarter of fiscal 2009.
Over the last three fiscal years, we have been 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 that provides rights to certain loop-mediated isothermal amplification
technology. This license provides us with rights for infectious disease testing in the United
States, Europe, and other geographic markets. We have branded our technology platform with the
name illumigeneTM. We currently are in active development using this molecular
technology for C. difficile, and are now completing beta site
evaluations and have recent data that meets or exceeds our
expectations. We intend to initiate
clinical trials in the second fiscal quarter of 2010 with a 510(k) application to follow
immediately thereafter. International revenues are likely in the late second quarter of fiscal
2010, with US sales to follow FDA clearance. Several other infectious diseases have been
identified for future development using this technology.
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Manufacturing
Our immunodiagnostic products require the production of highly specific and sensitive antigens and
antibodies. We produce substantially all of our own requirements including monoclonal antibodies
and polyclonal antibodies, plus a variety of fungal, bacterial, and viral antigens. We believe
that we have sufficient manufacturing capacity for anticipated growth in the near term.
Intellectual Property, Patents, and Licenses
We own or license US and foreign patents, most of which are for products manufactured by our US
Diagnostics operating segment. Sales of these products are as follows:
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Number of |
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% of consolidated sales |
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products |
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2009 |
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2008 |
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Product Family |
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H. pylori |
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2 |
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12 |
% |
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11 |
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Upper respiratory |
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2 |
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4 |
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Other |
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Total patented products |
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Patents for the two H. pylori products expire between 2016 and 2017, while patents for the two
upper respiratory products expire in 2022 and 2027. The remaining eight patented products for
which we own or license patents are spread over three product families.
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.
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Sales of our diagnostic products in foreign countries are subject to foreign government regulation,
the requirements of which vary substantially from country to country. The time required to obtain
approval by a foreign country may be longer or shorter than that required for FDA approval and the
requirements may differ.
Meridians Cincinnati manufacturing facility is certified to ISO 13485.
European Diagnostics Operating Segment
Our European Diagnostics operating segments business focuses on the sale and distribution of
diagnostic test kits, manufactured both by our US Diagnostics operating segment and by third-party
vendors. Approximately 75% of third-party sales for fiscal 2009 for this operating segment were
products purchased from our US Diagnostics operating segment. Third-party sales for this operating
segment were $25,870, $27,980, and $23,563 for fiscal 2009, 2008 and 2007, respectively. As of
September 30, 2009, the European Diagnostics operating segment had 40 employees, including 15
employees in the direct sales force. Our European Diagnostics operating segments sales and
distribution network consists of direct sales forces in Belgium, France, Holland, and Italy, and
independent distributors in other European countries, Africa and the Middle East. The European
Diagnostics operating segment maintains a distribution center in Milan, Italy. The primary markets
and customers for this operating segment are hospitals and reference laboratories.
The European Diagnostics operating segments functional currency is the Euro. The translation of
Euros into US dollars is subject to exchange rate fluctuations.
Life Science Operating Segment
Overview
Our Life Science operating segments business focuses on the development, manufacture, sale, and
distribution of bulk antigens, antibodies, and reagents used by researchers and other diagnostic
companies, as well as contract development and manufacturing services under clinical cGMP
conditions. Third-party sales for this operating segment were $23,434, $23,240, and $24,555 for
fiscal 2009, 2008 and 2007, respectively. As of September 30, 2009, our Life Science operating
segment had 107 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 2009, 30% of third-party sales for this segment were to two
customers. For one of these two customers, we have 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.
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Our clinical cGMP protein production facility in Memphis, Tennessee serves as an enabling
technology for process development and large-scale manufacturing for biologicals used in new drugs
and vaccines. The size of the facility is intended to accommodate manufacturing requirements for
Phase I and Phase II clinical trials. The customer base for this aspect of our Life Science
business includes biopharmaceutical and biotechnology companies, as well as government agencies,
such as the National Institutes of Health. Revenues for our Life Science operating segment, in the
normal course of business, may be affected from quarter to quarter by the timing and nature of
arrangements for contract services work, which may have longer production cycles than bioresearch
reagents and bulk antigens and antibodies, as well as buying patterns of major customers. See Note
1 (i) to the Consolidated Financial Statements herein for revenue recognition policies. Our
revenues for contract services were $1,635, $1,477, and $765 in fiscal 2009, 2008 and 2007,
respectively.
During fiscal 2008, we acquired certain technologies and products from Vybion, Inc., including
infectious disease recombinant proteins and cardiac antigens. This acquisition added important
technologies and capabilities to our Life Science business and expanded our Life Science brands.
The acquired technologies added proprietary manufacturing know-how and access to important patent
licenses for the development and production of recombinant proteins, an emerging technology in life
sciences.
Products, Markets and Growth Strategies
Our Life Science operating segments businesses have been assembled via acquisitions (BIODESIGN
International in fiscal 1999, Viral Antigens in fiscal 2000, and, most recently, OEM Concepts in
fiscal 2005). Historically, these businesses were run autonomously. In recent years, growth
strategies have been developed around sales and marketing integration, new product development
integration, and the acquisition of complementary product lines, such as the recombinant antigen
products acquired from Vybion, Inc. in fiscal 2008.
Antibodies, antigens and reagents 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 products are typically sold in bulk quantities, and may also be custom-designed
for a particular manufacturers requirements. Sales efforts are focused on multi-year supply
agreements in order to provide stability in volumes and pricing. We believe this benefits both us
and our customers.
With respect to our contract cGMP services, we believe that the business prospects are also
favorable despite our recent revenue trends for this brand. During fiscal 2009 and going into
fiscal 2010, we either completed services or had services in progress for 7 vaccine projects.
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Research and Development
Our Life Science operating segments research and development organization consists of four
research scientists. Research and development expenses for our Life Science operating segment for
fiscal 2009, 2008 and 2007 were $1,219, $1,305, and $1,514, respectively. This research and
development organization is heavily involved in vaccine development and production activities for
our cGMP facility.
Manufacturing and Government Regulation
The cGMP clinical grade proteins that are produced in our Memphis facility are intended to be used
as injectibles, and, as such, they are produced under cGMP Regulations for Biologics and Human
Drugs under the auspices of the FDA. Approval and licensing, following clinical trials, of these
products is the responsibility of the applicant, who owns the rights to each protein. Typically,
the customer is the applicant, not Meridian Life Science.
All of the Meridian Life Science facilities are ISO 9001:2000 certified and EC 1774:2002 approved.
Competition
Diagnostics
The market for diagnostic tests is a multi-billion dollar international industry, which is highly
competitive. Many of our competitors are larger than we are with greater financial, research,
manufacturing and marketing resources. Important competitive factors for Meridians products
include product quality, price, ease of use, customer service, and reputation. In a broader sense,
industry competition is based upon scientific and technological capability, proprietary know-how,
access to adequate capital, the ability to develop and market products and processes, the ability
to attract and retain qualified personnel and the availability of patent protection. To the extent
that our product lines do not reflect technological advances, our ability to compete in those
product lines could be adversely affected.
The diagnostic test industry is highly fragmented and segmented. Of importance in the industry are
mid-sized medical diagnostic specialty companies, like Meridian, that offer multiple, broad product
lines and have the ability to deliver new, high value products quickly to the marketplace. Among
the companies with which we compete in the marketing of one or more of our products are the
diagnostic product divisions of Abbott Laboratories Inc., Becton, Dickinson and Company, Thermo
Fisher and Siemens. We also compete with smaller companies such as Quidel Corporation and
Inverness Medical Innovations.
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C. difficile is one of our primary disease categories. Over the last 12-18 months, considerable
confusion has developed in this market over the relative benefits of the various test methods
available (toxin testing, antigen testing and molecular testing). Several new competitive
products, including molecular assays, have recently been introduced into this market, causing
competitive pressures for our products. We expect to combat these competitive pressures with our
strong position in toxin testing and the development of our illumigeneTM molecular C.
difficile product. Upon launch of illumigeneTM C. difficile, we will be the only
manufacturer offering toxin, antigen, and molecular products for C. difficile testing.
Life Science
The market for bulk biomedical reagents is highly competitive. Important competitive factors
include product quality, price, customer service, and reputation. We face competitors, many of
which have greater financial, research and development, sales and marketing, and manufacturing
resources, and where sole-source supply arrangements do not exist. From time to time, customers
may choose to manufacture their biomedical reagents in-house rather than purchase from outside
vendors such as Meridian.
The market for contract manufacturing in a validated cGMP facility, such as our Memphis facility,
is also competitive. Important competitive factors include reputation, customer service, and
price. Although the product application for this facility was built from our existing expertise in
cell culture manufacturing techniques, we face competitors with greater experience in contract
manufacturing in a clinical cGMP environment.
Acquisitions
Acquisitions have played an important role in the historical growth of our businesses. Our
acquisition objectives include, among other things, (i) enhancing product offerings, (ii) improving
product distribution 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 $41,438 or
28% of consolidated fiscal 2009 sales, $44,430 or 32% of consolidated fiscal 2008 sales and $38,691
or 31% of consolidated fiscal 2007 sales. Domestic exports for our US Diagnostics and Life Science
operating segments were $15,568, $16,450,
and $15,128 in fiscal 2009, 2008 and 2007, respectively. We expect to continue to look to
international markets as a source of new revenues and growth in the future.
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Environmental
We are a conditionally exempt, small quantity generator of hazardous waste and have a US EPA
identification number. We are in compliance with applicable portions of the federal and state
hazardous waste regulations and have never been a party to any environmental proceeding.
ITEM 1A.
RISK FACTORS
In addition to the other information set forth in this report, you should carefully consider the
following factors which could materially affect our business, financial condition, cash flows or
future results. Any one of these factors could cause our actual results to vary materially from
recent results or from anticipated future results. The risks described below are not the only
risks facing our Company. Additional risks and uncertainties not currently known to us or that we
currently deem to be immaterial also may materially adversely affect our business, financial
condition and/or operating results.
Risks Affecting Growth and Profitability of our Business
We may be unable to develop new products and services or acquire products and services on favorable
terms.
The medical diagnostic and life science industries are characterized by ongoing technological
developments and changing customer requirements. As such, our results of operations and continued
growth depend, in part, on our ability in a timely manner to develop or acquire rights to, and
successfully introduce into the marketplace, enhancements of existing products and services or new
products and services that incorporate technological advances, meet customer requirements, and
respond to products developed by our competition. 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 2009, 2008, and 2007, we incurred $8,428, $6,183, and $6,085, respectively, in research and
development expenses. We expect to continue to invest in our research and development activities.
- 14 -
We may be unable to successfully integrate operations or to achieve expected cost savings from
acquisitions we make.
One of our main growth strategies is the acquisition of companies and/or products. Although
additional acquisitions of companies and products may enhance the opportunity to increase net
earnings over time, such acquisitions could result in greater administrative burdens, increased
exposure to the uncertainties inherent in marketing new products, and financial risks of additional
operating costs. The principal benefits expected to result from any acquisitions we make will not
be achieved fully unless we are able to successfully integrate the operations of the acquired
entities with our operations and realize the anticipated synergies, cost savings, and growth
opportunities from integrating these businesses into our existing businesses. We cannot provide any
assurance that we will be able to identify and complete additional acquisitions on terms we
consider favorable or that, if completed, will be successfully integrated into our operations.
Revenues for our diagnostic operating segments may be impacted by our reliance upon two key
distributors, seasonal factors and sporadic outbreaks, and changing diagnostic market conditions.
Key Distributors
Our US Diagnostic operating segments sales through two distributors were 58% and 54%,
respectively, of the US Diagnostics operating segments total sales for fiscal 2009 and fiscal
2008, or 38% and 34%, respectively, of our consolidated sales for fiscal 2009 and fiscal 2008.
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.
In addition, buying patterns of these two distributors may fluctuate from quarter to quarter,
potentially leading to uneven concentration levels on a quarterly basis. However, we expect that,
over a 12-month period, these distributors orders would follow a normal buying pattern.
Seasonal Factors and Sporadic Outbreaks
Our principal business is the sale of a broad range of diagnostic test kits for common upper
respiratory, gastrointestinal, viral, and parasitic infectious diseases. Certain infectious
diseases may be seasonal in nature, while others may be associated with sporadic outbreaks, such as
foodborne illnesses. While we believe that the breadth of our diagnostic product lines reduces the
risk that infections subject to seasonality and sporadic outbreaks will cause significant
variability in diagnostic revenues, we can make no assurance that revenues will not be negatively
impacted period over period by such factors.
- 15 -
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.
We could be adversely affected by healthcare reform legislation.
Third-party payers for medical products and services, including state and federal governments, are
increasingly concerned about escalating health care costs and can indirectly affect the pricing or
the relative attractiveness of our products by regulating the maximum amount of reimbursement they
will provide for diagnostic testing services. In recent years, pressure has been increasing for
the US government to enact comprehensive healthcare reform. These proposals have been wide-ranging
on both state and federal levels. We are unable to predict whether any such legislation may be
enacted in the US or elsewhere or what effect such legislation may have on reimbursement rates for
our products. If reimbursement amounts for diagnostic testing services are decreased in the
future, such decreases may reduce the amount that will be reimbursed to hospitals or physicians for
such services and consequently could place constraints on the levels of overall pricing, which
could have a material effect on our sales and/or results of operations.
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 two customers were
30% and 36%, respectively, of the Life Science operating segments total sales for fiscal 2009 and
fiscal 2008, or 5% and 6%, respectively, of our consolidated sales for fiscal 2009 and fiscal 2008.
For one of these two customers, we have 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 two other significant customers who purchase antigens,
antibodies and reagents, which together comprised 5% and 4%, respectively, of the operating
segments total sales for fiscal 2009 and 2008. 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.
- 16 -
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.
During the last several months, molecular tests have been introduced for the first time into the C.
difficile market, which is a significant source of revenues for us. Our ability to continue to
successfully compete in the C. difficile market is partly dependent upon our ability to
successfully develop and market our own molecular test. We currently are in active development of
our own molecular C. difficile test under our illumigeneTM brand, with clinical trials
expected to start in our second fiscal quarter of 2010.
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 28% of our net sales
for fiscal 2009 and approximately 32% of our net sales for fiscal 2008 were attributable to
international markets. For fiscal 2009, 53% of our international sales were made in Euros, with the
remaining 47% made in US dollars. We are subject to the risks associated with fluctuations in the
US dollar-Euro exchange rates. We are also subject to other risks associated with international
operations, including longer customer payment cycles, tariff regulations, requirements for export
licenses, instability of foreign governments, and governmental requirements with respect to the
importation and distribution of medical devices and antigens, antibodies and reagents, all of which
may vary by country.
Risks Affecting our Manufacturing Operations
We are subject to comprehensive regulation, and our ability to earn profits may be restricted by
these regulations.
Medical device diagnostics and the manufacture, sale, and distribution of bulk antigens,
antibodies, and reagents are highly regulated industries. We cannot provide any assurance that we
will be able to obtain necessary governmental clearances or approvals or timely clearances or
approvals to market future products in the United States and other countries. Costs and
difficulties in complying with laws and regulations administered by the US Food and Drug
Administration, the US Department of Agriculture, the US Department of Commerce, the US Drug
Enforcement Agency, the Centers for Disease Control, or other regulators can result in
unanticipated expenses and delays and interruptions to the sale of new and existing products.
Contract manufacturing of proteins and other biologicals is regulated by the US Food and Drug
Administration.
- 17 -
Regulatory approval can be a lengthy, expensive, and uncertain process, making the timing and costs
of approvals difficult to predict. The failure to comply with these regulations can result in
delay in obtaining authorization to sell products, seizure or recall of products, suspension or
revocation of authority to manufacture or sell products, and other civil or criminal sanctions.
Significant interruptions in production at our principal manufacturing facilities and/or
third-party manufacturing facilities would adversely affect our business and operating results.
Products and services manufactured at our Cincinnati, Ohio, Boca Raton, Florida, Memphis,
Tennessee, and Saco, Maine facilities comprised 72% of our Diagnostics revenues and 75% of our Life
Science revenues. Our global supply of these products and services is dependent on the
uninterrupted and efficient operation of these facilities. In addition, we currently rely on a
small number of third-party manufacturers to produce certain of our diagnostic products. The
operations of our facilities or these third-party manufacturing facilities could be adversely
affected by power failures, natural or other disasters, such as earthquakes, floods, tornadoes or
terrorist threats. Although we carry insurance to protect against certain business interruptions
at our facilities, there can be no assurance that such coverage will be adequate or that such
coverage will continue to remain available on acceptable terms, if at all. Any significant
interruption in the Companys or third-party manufacturing capabilities could materially and
adversely affect our operating results.
We are dependent on sole-source suppliers for certain critical components and products. A supply
interruption could adversely affect our business.
Our products are made from a wide variety of raw materials that are generally available from
multiple 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.
We have no individual products that represent greater than 10% of consolidated sales for which we
have a sole source supplier. We sell certain respiratory tests for influenza and respiratory
syncytial virus that we purchase from Inverness Medical Innovations. These products represented
13%, 14%, and 11%, respectively, of third-party sales for our US Diagnostics operating segment in
fiscal 2009, 2008, and 2007, respectively. While we do not have a long-term supply agreement with
this vendor for these products, during fiscal 2008, we launched our own internally-developed
products that compete with these products in the market. Two foodborne products
sourced from another vendor accounted for 7% and 5% of third-party sales for our US Diagnostics
operating segment in fiscal 2009 and 2008, respectively.
- 18 -
Risks Related to Intellectual Property and Product Liability
We may be unable to protect or obtain proprietary rights that we utilize or intend to utilize.
In developing and manufacturing our products, we employ a variety of proprietary and patented
technologies. In addition, we have licensed, and expect to continue to license, various
complementary technologies and methods from academic institutions and public and private companies.
We cannot provide any assurance that the technologies that we own or license provide protection
from competitive threats or from challenges to our intellectual property. In addition, we cannot
provide any assurances that we will be successful in obtaining licenses or proprietary or patented
technologies in the future.
Product infringement claims by other companies could result in costly disputes and could limit our
ability to sell our products.
Litigation over intellectual property rights is prevalent in the diagnostic industry. As the
market for diagnostics continues to grow and the number of participants in the market increases, we
may increasingly be subject to patent infringement claims. It is possible that a third-party may
claim infringement against us. If found to infringe, we may attempt to obtain a license to such
intellectual property, however, we may be unable to do so on favorable terms, or at all.
Additionally, if our products are found to infringe on third-party intellectual property, we may be
required to pay damages for past infringement and lose the ability to sell certain products,
causing our revenues to decrease. We currently carry intellectual property insurance that covers
damages and defense costs from our potential infringement on other third-party patents at levels
that we believe are commercially reasonable, although there is no assurance that it will be
adequate to cover claims that may arise. Any substantial underinsured loss resulting from such a
claim could have a material adverse affect on our profitability and the damage to our reputation in
the industry could have a material adverse affect on our business.
If product liability lawsuits are successfully brought against us, we may incur substantial
liabilities and may have to limit or cease sales of our products.
The testing, manufacturing, and marketing of medical diagnostic products involves an inherent risk
of product liability claims. If we cannot successfully defend ourselves against product liability
claims, we may incur substantial liabilities or be required to limit or cease sales of our
products. We currently carry product liability insurance at a level we believe is commercially
reasonable, although there is no assurance that it will be adequate to cover claims that may arise.
In certain customer contracts, we indemnify third parties for certain product liability claims
related to our products. These indemnification obligations may cause us to pay significant sums of
money for claims that are covered by these indemnifications. In addition, a defect in the design
or manufacture of our products could have a material adverse affect on our reputation in the
industry and subject us to claims of liability for injury and otherwise. Any substantial
underinsured loss resulting from 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.
- 19 -
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.
Over the last 12 to 24 months, the credit markets and the banking industry have gone through a
period of unprecedented turmoil and upheaval characterized by the bankruptcy, failure, collapse, or
sale of various financial institutions. In response, the US federal government put into place a
number of economic measures designed to stabilize the markets, the ultimate effect of which cannot
yet be predicted. Should our ability to borrow money to finance our operations from our existing
lender under our bank credit agreement be impaired our results of operations could be materially
affected.
We face other risks related to the current credit crisis.
We currently generate significant operating cash flows, which combined with access to the credit
markets provides us with discretionary funding capacity for research and development and other
strategic activities. Current uncertainty in global economic conditions poses a risk to the
overall economy that could impact demand for our products, as well as our ability to manage normal
commercial relationships with our customers, suppliers and creditors, including financial
institutions. If the current situation deteriorates significantly, our business could be negatively
impacted, including such areas as reduced demand for our products from a slow-down in the general
economy, supplier or customer disruptions resulting from tighter credit markets and/or temporary
interruptions in our ability to conduct day-to-day transactions through our financial
intermediaries involving the payment to or collection of funds from our customers, vendors and
suppliers. If the current credit crisis were to continue to worsen such that we were unable to
access the credit market, it could impair our ability to fund discretionary spending.
- 20 -
Risks Related to Our Common Stock
Our board of directors has the authority to issue up to 1,000 shares of undesignated preferred
stock and to determine the rights, preferences, privileges and restrictions, including voting
rights, of such shares without any future vote or action by the shareholders. The issuance of
preferred stock under certain circumstances could have the effect of delaying or preventing a
change in control of our company. Ohio corporation law contains provisions that may discourage
takeover bids for our company that have not been negotiated with the board of directors. Such
provisions could limit the price that investors might be willing to pay in the future for shares of
our common stock. In addition, sales of substantial amounts of such shares in the public market
could adversely affect the market price of our common stock and our ability to raise additional
capital at a price favorable to us.
ITEM 1B.
UNRESOLVED 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 the Village of Newtown, 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.
In September 2009, we purchased a two-story building in the Village of Newtown, less than one mile
from our current facility, to augment our research and development, manufacturing, and
administrative capacity for our US Diagnostics operating segment. This facility consists of
approximately 22,000 square feet on 3.5 acres of land. We anticipate expanding a portion of our US
operations into this space during the next twelve months.
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
Nice, France and Nivelles, Belgium for sales and administrative functions.
Our Life Science operations are conducted in several facilities in Saco, Maine, Memphis, Tennessee,
and Boca Raton, Florida. Our facility in Saco, Maine presently contains approximately 23,000
square feet for manufacturing, sales, distribution and administrative functions, and is owned by
us. Our facility in Memphis, Tennessee consists of two buildings totaling approximately 34,000
square feet, including approximately 27,000 square feet of manufacturing space, and is owned by us.
Our leased facility in Boca Raton, Florida contains approximately 7,500 square feet of
manufacturing space.
- 21 -
ITEM 3.
LEGAL PROCEEDINGS
We are a party to various litigation matters that we believe are in the normal course of business.
The ultimate resolution of these matters is not expected to have a material adverse effect on our
financial position, results of operations or cash flows. No provision has been made in the
accompanying consolidated financial statements for these matters.
ITEM 4.
SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
Not applicable.
PART II.
ITEM 5.
MARKET FOR REGISTRANTS COMMON
EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES
Refer to Forward Looking Statements following the Index in front of the Form 10-K and Item 1A
Risk Factors on Pages 14 through 21 of this Annual Report.
Common Stock Information on the inside back cover of the Annual Report to Shareholders for 2009
and Quarterly Financial Data relating to our dividends in Note 10 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 $0.65 per share, $0.53 per share, and $0.40 per share in fiscal 2009, fiscal
2008, and fiscal 2007, respectively.
On May 11, 2007, we affected a three-for-two stock split for shareholders of record on May 4, 2007.
All references in this Annual Report to number of shares and per share amounts reflect the effects
of this stock split.
As of September 30, 2009, there were approximately 950 holders of record and approximately 22,000
beneficial owners of our common shares.
- 22 -
ITEM 6.
SELECTED FINANCIAL DATA
Incorporated by reference from inside front cover of the Annual Report to Shareholders for 2009.
ITEM 7.
MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL
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 14 through 21 of this Annual Report.
Overview:
Our Diagnostics operating segments provide the largest share of our consolidated revenues, 84%, 83%
and 80% for fiscal 2009, 2008 and 2007, respectively. Sales from our four focus families (C.
difficile, Upper Respiratory, H. pylori, and Foodborne) comprised 71% of our Diagnostics operating
segments revenues during fiscal 2009.
Revenue growth during the first half of fiscal 2009 for our Diagnostics operating segments was a
negative 3%, as a result of a weakened global economy, inventory de-stocking by our major
distributors and a relatively mild influenza season. Revenue growth during the second half of
fiscal 2009 was a positive 18%, primarily driven by the world-wide outbreak of novel A (H1N1)
influenza that began in April and continues today, and new product revenues in our foodborne
family. Revenue growth for the full fiscal year in 2009 was also impacted by foreign currency
translation, which contributed translation losses of approximately $2,400. The USD/Euro exchange
rate averaged approximately 1.35 during fiscal 2009, compared to 1.50 during fiscal 2008.
Upper Respiratory Products
During fiscal 2009, upper respiratory sales for our Diagnostics operating segments increased 24%
compared to fiscal 2008, driven by the outbreak of novel A (H1N1) influenza virus that began to
spread across countries in the northern hemisphere during the second half of fiscal 2009. The
novel A (H1N1) influenza outbreak created an early start to the 2009-2010 influenza season,
resulting in increased upper respiratory sales for influenza products in the third and fourth
quarters of fiscal 2009. This outbreak has also created an increased interest in influenza testing
in European markets where rapid testing has not been traditionally performed, resulting in revenue
growth of 55% in this operating segment on an organic basis. At the present time, seasonal
influenza has not yet emerged; however, novel A (H1N1) activity continues to be high in the United
States and Europe. Sales of our influenza products have remained steady during the first quarter
of fiscal 2010.
The 2008-09 respiratory season was the first full season in which we sold our internally developed
and manufactured TRU FLU® and TRU RSV® products. Our TRU FLU® and
TRU RSV® products represented approximately 25% of our total influenza and respiratory
syncytial virus product sales for fiscal 2009, compared to less than 10% in fiscal 2008. We expect
this percentage to continue to increase, yielding continuing improvements in gross profit margins.
Our TRU® format, with its sample tube and test device, offers better
containment of the specimen sample compared to card-type devices. Customers are reacting
positively to this feature, especially in the current pandemic.
- 23 -
Foodborne Products
Over the last three fiscal years, we have launched three foodborne products, ImmunoCard
STAT!® EHEC in fiscal 2007, and PremierTM CAMPY and ImmunoCard
STAT!® CAMPY in fiscal 2009. The volume growth from these new products has more than
doubled the global revenues for this disease family since fiscal 2007, and this is now a $10,000+
product family. The disease family is expected to generate significant sales growth in fiscal
2010.
C. difficile products
Considerable confusion has developed in the C. difficile market over the
relative benefits of the various test methods available (toxin testing, antigen testing and
molecular testing). Several new competitive products, including molecular assays, have recently
been introduced into this market, causing competitive pressures for our products and slowing organic growth rates to single digits. We expect to
combat these competitive pressures with our strong position in toxin testing and the development of
our illumigeneTM molecular C. difficile product. Our new molecular test for C.
difficile on our illumigeneTM platform is in the final stages of product design. We are
currently conducting beta site evaluations and have recent data that meets or exceeds
our expectations. We are targeting revenue contributions from the launch of this technology later
in the first half of fiscal 2010.
H. pylori products
During fiscal 2009, sales of our H. pylori products grew 10% for our US Diagnostics
operating segment and 2% for our European Diagnostics operating segment on an organic basis. Our
partnerships with managed care companies in promoting the health and economic benefits of a test
and treat strategy is beginning to move physician behavior away from serology-based testing to
direct antigen testing. The modest level of growth for our European Diagnostics operating segment
reflects impact from pricing pressures from competitive products in European markets.
- 24 -
Life Science Operating Segment
Sales for our Life Science operating segment increased 1% for fiscal 2009 compared to fiscal 2008.
This slight increase reflects buying patterns of our two largest diagnostic manufacturing
customers, who accounted for 30%
of the Life Science Operating segments sales in fiscal 2009 compared to 36% in fiscal 2008. We
expect high single-digit growth for this operating segment in fiscal 2010. Due to manufacturing
efficiency improvements at our Memphis, Tennessee facility, we have seen significant year-over-year
improvements in operating income contributions in fiscal 2009 compared to fiscal 2008.
All Segments
We have generated a consolidated gross profit margin of 63% for fiscal 2009. This level of gross
profit margin reflects favorable efficiencies from automation in our US Diagnostics manufacturing
plant, changing product mix in favor of higher margin manufactured products over lower margin
third-party influenza and RSV products within the upper respiratory product family, and improved
operating performance and utilization of our Life Science manufacturing facility in Memphis,
Tennessee. Although foreign currency exchange rates had a negative effect on sales of our European
Diagnostics operating segment, they had no significant effect on consolidated gross profit or
consolidated operating income due to natural hedges. Our US Diagnostics operating segment markets
and sells certain Meridian-branded diagnostic test kits that are sourced from European suppliers in
Spain and Germany. These kits are purchased in Euros, which provides a natural hedge to gross
profit and operating income on a consolidated basis.
The recessionary state of the economy during fiscal 2009 is affecting not only the US, but also
countries around the world. We cannot predict the timing or magnitude of recovery from this
recession. If economic conditions worsen or remain in a recessed state for an extended period of
time, our sales levels could be adversely affected by customer buying patterns in their efforts to
conserve cash and manage inventory levels. On a longer-term basis, in a recessed economic state,
our sales levels could be adversely impacted by the number of diagnostic tests performed in the
healthcare system, if, for example, there were declines in physician office visits and/or hospital
admissions. Our product portfolios, for both diagnostics and life science, deal with acute patient
symptoms and infectious diseases. To date, we have not seen any significant reduction in end-user
demand for our major products as a result of economic conditions.
From a cash flow perspective, we expect cash flows from operations to be sufficient to fund working
capital requirements, capital expenditure requirements and dividends over the next 12 months.
- 25 -
Financial discipline is one of our fundamental principles in running the day-to-day business
regardless of the state of the business cycle and economy. 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, regardless of macro-economic market conditions.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2009 |
|
|
2008 |
|
|
2007 |
|
Gross profit |
|
|
63 |
% |
|
|
62 |
% |
|
|
61 |
% |
Operating expenses |
|
|
30 |
% |
|
|
30 |
% |
|
|
32 |
% |
Operating income |
|
|
33 |
% |
|
|
32 |
% |
|
|
28 |
% |
Operating Segments:
Our reportable operating segments are US Diagnostics, European Diagnostics, and Life Science. The
US Diagnostics operating segment consists of manufacturing operations in Cincinnati, Ohio, and the
sale and distribution of diagnostic test kits in the US and countries outside of Europe, Africa and
the Middle East. The European Diagnostics operating segment consists of the sale and distribution
of diagnostic test kits in Europe, Africa and the Middle East. The Life Science operating segment
consists of manufacturing operations in Memphis, Tennessee, Saco, Maine, and Boca Raton, Florida,
and the sale and distribution of bulk antigens, antibodies, and bioresearch reagents domestically
and abroad. The Life Science operating segment also includes the contract development and
manufacture of proteins and other biologicals for use by biopharmaceutical and biotechnology
companies engaged in research for new drugs and vaccines.
Revenues for the Diagnostics operating segments, in the normal course of business, may be affected
by buying patterns of major distributors, seasonality and strength of certain diseases, and foreign
currency exchange rates. Revenues for the Life Science operating segment, in the normal course of
business, may be affected by the timing and nature of arrangements for contract services work,
which may have longer production cycles than bioresearch reagents and bulk antigens and antibodies,
as well as buying patterns of major customers. We believe that the overall breadth of our product
lines serves to reduce the variability in consolidated revenues.
Results of Operations:
Fourth Quarter
Net earnings for the fourth quarter of fiscal 2009 increased 16% to $8,930, or $0.22 per diluted
share, from net earnings for the fourth quarter of fiscal 2008 of $7,684, or $0.19 per diluted
share. This increase is primarily attributable to increased sales coupled with management of
discretionary spending. Sales for the fourth quarter of fiscal 2009 were $42,461, an increase of
$5,986, or 16%, compared to the fourth quarter of fiscal 2008.
Sales for the US Diagnostics operating segment for the fourth quarter of fiscal 2009 increased 24%
compared to the fourth quarter of fiscal 2008, and benefited from volume increases in sales of
influenza products related to the novel A (H1N1) influenza outbreak, along with growth in our
Foodborne products. Importantly, sales of our TRU FLU® and TRU RSV® products
increased to approximately 30% of our total influenza and respiratory syncytial virus product sales
during the quarter. Sales for our European Diagnostics and Life Science operating segments
increased 5% and 1%, respectively, during the fourth quarter of fiscal 2009 compared to the fourth
quarter of fiscal 2008. On an organic basis, which excludes the effects of currency translation,
sales for our European Diagnostics operating segment increased 10% during the fourth quarter,
benefitting from sales of our TRU FLU® and TRU RSV® products.
- 26 -
Fiscal Year
Net earnings for fiscal 2009 increased 8% to $32,759 or $0.80 per diluted share from net earnings
for fiscal 2008 of $30,202 or $0.74 per diluted share. Results of operations for fiscal 2009
compared to fiscal 2008 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, 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 6 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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2009 vs |
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|
2008 vs |
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|
2008 |
|
|
2007 |
|
|
|
2009 |
|
|
2008 |
|
|
2007 |
|
|
Change |
|
|
Change |
|
Net Earnings |
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
US GAAP basis |
|
$ |
32,759 |
|
|
$ |
30,202 |
|
|
$ |
26,721 |
|
|
|
8 |
% |
|
|
13 |
% |
Tax benefit not expected to recur in
the future |
|
|
|
|
|
|
|
|
|
|
(2,425 |
) |
|
|
|
% |
|
|
100 |
% |
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|
|
|
|
|
|
|
|
|
|
|
Excluding tax benefit |
|
$ |
32,759 |
|
|
$ |
30,202 |
|
|
$ |
24,296 |
|
|
|
8 |
% |
|
|
24 |
% |
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2009 |
|
|
2008 |
|
|
2007 |
|
|
Change |
|
|
Change |
|
Net Earnings per Basic Common Share |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
US GAAP basis |
|
$ |
0.81 |
|
|
$ |
0.75 |
|
|
$ |
0.67 |
|
|
|
8 |
% |
|
|
12 |
% |
Tax benefit not expected to recur in
the future |
|
|
|
|
|
|
|
|
|
|
(0.06 |
) |
|
|
|
% |
|
|
100 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Excluding tax benefit |
|
$ |
0.81 |
|
|
$ |
0.75 |
|
|
$ |
0.61 |
|
|
|
8 |
% |
|
|
23 |
% |
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2009 |
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|
2008 |
|
|
2007 |
|
|
Change |
|
|
Change |
|
Net Earnings per Diluted Common Share |
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|
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|
|
|
|
|
|
US GAAP basis |
|
$ |
0.80 |
|
|
$ |
0.74 |
|
|
$ |
0.66 |
|
|
|
8 |
% |
|
|
12 |
% |
Tax benefit not expected to recur in
the future |
|
|
|
|
|
|
|
|
|
|
(0.06 |
) |
|
|
|
% |
|
|
100 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Excluding tax benefit |
|
$ |
0.80 |
|
|
$ |
0.74 |
|
|
$ |
0.60 |
|
|
|
8 |
% |
|
|
23 |
% |
|
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|
|
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|
- 27 -
Fiscal Year Ended September 30, 2009 Compared to Fiscal Year Ended September 30, 2008 and
Fiscal Year Ended September 30, 2008 Compared to Fiscal Year Ended September 30, 2007.
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2009 |
|
|
2008 |
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|
vs. |
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|
vs. |
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2008 |
|
|
2007 |
|
Sales Breakdown |
|
2009 |
|
|
2008 |
|
|
2007 |
|
|
Inc (Dec) |
|
|
Inc (Dec) |
|
US Diagnostics |
|
$ |
98,970 |
|
|
$ |
88,419 |
|
|
$ |
74,845 |
|
|
|
12 |
% |
|
|
18 |
% |
European Diagnostics |
|
|
25,870 |
|
|
|
27,980 |
|
|
|
23,563 |
|
|
|
(8 |
)% |
|
|
19 |
% |
Life Science |
|
|
23,434 |
|
|
|
23,240 |
|
|
|
24,555 |
|
|
|
1 |
% |
|
|
(5 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Consolidated |
|
$ |
148,274 |
|
|
$ |
139,639 |
|
|
$ |
122,963 |
|
|
|
6 |
% |
|
|
14 |
% |
|
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International |
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|
US Diagnostics
export |
|
$ |
5,657 |
|
|
$ |
6,643 |
|
|
$ |
6,558 |
|
|
|
(15 |
)% |
|
|
1 |
% |
Life Science export |
|
|
9,911 |
|
|
|
9,807 |
|
|
|
8,570 |
|
|
|
1 |
% |
|
|
14 |
% |
European Diagnostics |
|
|
25,870 |
|
|
|
27,980 |
|
|
|
23,563 |
|
|
|
(8 |
)% |
|
|
19 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
41,438 |
|
|
$ |
44,430 |
|
|
$ |
38,691 |
|
|
|
(7 |
)% |
|
|
15 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
% of total sales |
|
|
28 |
% |
|
|
32 |
% |
|
|
31 |
% |
|
|
|
|
|
|
|
|
Growth for our Diagnostics operating segments was led by volume increases in upper respiratory
products driven by the outbreak of novel A (H1N1) influenza experienced in the United States
beginning in the spring of 2009. Sales for this product family increased approximately 23% over
fiscal 2008, which showed double-digit increases over fiscal 2007. Sales of upper respiratory
products grew 22% in fiscal 2009 for the US Diagnostics operating segment, and grew 55% for our
European Diagnostics operating segment on an organic basis. Sales increases for this product
family included sales from our new products launched during the first quarter of fiscal 2008, TRU
FLU® and TRU RSV®. These two products represented
approximately 25% of our total influenza and respiratory syncytial virus product sales for fiscal
2009, compared to less than 10% in fiscal 2008.
We also saw significant volume increases for our foodborne products family, specifically related to
our ImmunoCard STAT!® EHEC product. The EHEC product was developed in collaboration
with Merck for detection of toxin-producing E. coli in patients that may have ingested contaminated
produce or meat products and was launched in fiscal 2007. Two new Campylobacter products were
launched during fiscal 2009, which also contributed to volume growth.
Our H. pylori product family showed modest growth for fiscal 2009 after double-digit growth for
fiscal 2008 for our Diagnostics operating segments. For our US Diagnostics operating segment,
sales growth for this product family was 10% in fiscal 2009. Our partnerships with managed care
companies in promoting the health and economic benefits of a test and treat strategy is beginning
to move physician behavior away from serology-based testing to direct antigen testing. For our
European diagnostics operating segment, our sales growth for this product family was 2% for fiscal
2009 on an organic basis. This modest level of growth reflects the impact of pricing pressures
with competitive products in European markets.
- 28 -
Considerable confusion has developed in the C.
difficile market over the relative benefits of the various test methods available (toxin testing,
antigen testing and molecular testing). Several new competitive products, including molecular
assays, have recently been introduced into this market, causing competitive pressures for our
products and slowing organic growth rates to single digits. We expect to combat these competitive pressures with our strong position in toxin
testing and the development of our illumigeneTM molecular C. difficile product.
We are currently conducting beta site evaluations and have recent data that meets or exceeds our expectations. We are targeting revenue
contributions from the launch of this technology later in the first half of fiscal 2010.
Sales growth for our European Diagnostics operating segment includes currency translation losses in
the amount of $2,419 for fiscal 2009 and gains in the amount of $2,743 for fiscal 2008. Organic
sales growth was 1% and 7% during fiscal 2009 and 2008, respectively. The organic growth in fiscal
2009 was driven by volume increases in upper respiratory related to the novel A (H1N1) influenza
outbreak. The organic growth in fiscal 2008 was driven by volume increases in C. difficile
products, principally ImmunoCardÒ Toxins A & B, as well as the third quarter
fiscal 2008 launch of TRU EBV-M® and TRU EBV-G®.
Fiscal 2009 and fiscal 2008 sales for the Life Science operating segment reflect changes in demand
and buying patterns of certain of our major diagnostic manufacturing customers and non-renewal of a
supply contract with the US Department of Defense. Changes in the US Department of Defenses
Critical Reagents program led to non-renewal of this contract after fiscal 2007. We sell three
main products to a major diagnostic manufacturing customer, who accounted for 16%, 21%, and 27% of
total sales for the Life Science operating segment for fiscal 2009, 2008 and 2007, respectively.
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|
|
|
|
|
|
|
|
|
|
2009 vs. |
|
|
2008 vs. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2008 |
|
|
2007 |
|
|
|
2009 |
|
|
2008 |
|
|
2007 |
|
|
Inc (Dec) |
|
|
Inc (Dec) |
|
Gross Profit |
|
$ |
92,783 |
|
|
$ |
86,480 |
|
|
$ |
74,940 |
|
|
|
7 |
% |
|
|
15 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross Profit Margin |
|
|
63 |
% |
|
|
62 |
% |
|
|
61 |
% |
|
|
1 |
% |
|
|
1 |
% |
The increases in gross profit margins from 2007 to 2009 reflect a stronger mix of sales from our
Diagnostics operating segments, including higher margins on rapid tests, and production
efficiencies from automation initiatives in our diagnostics manufacturing facility. Manufacturing
efficiency improvements at our Memphis, Tennessee facility, have also contributed to year-over-year
improvements in gross profit in fiscal 2009 compared to fiscal 2008.
- 29 -
Our overall operations consist of the sale of diagnostic test kits for various disease states and
in alternative test formats, as well as bioresearch reagents, bulk antigens and antibodies,
proficiency panels, and contract research and development and contract manufacturing services.
Product sales mix shifts, in the normal course of business, can cause the consolidated gross
profit margin to fluctuate by several points.
|
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research & |
|
|
Selling & |
|
|
General & |
|
|
Total Operating |
|
|
|
Development |
|
|
Marketing |
|
|
Administrative |
|
|
Expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2007 Expenses |
|
$ |
6,085 |
|
|
$ |
17,124 |
|
|
$ |
16,701 |
|
|
$ |
39,910 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
% of Sales |
|
|
5 |
% |
|
|
14 |
% |
|
|
14 |
% |
|
|
32 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fiscal 2008
Increases
(Decreases): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
US Diagnostics |
|
|
307 |
|
|
|
1,523 |
|
|
|
(293 |
) |
|
|
1,537 |
|
European Diagnostics |
|
|
|
|
|
|
423 |
|
|
|
389 |
|
|
|
812 |
|
Life Science |
|
|
(209 |
) |
|
|
(300 |
) |
|
|
380 |
|
|
|
(129 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2008 Expenses |
|
$ |
6,183 |
|
|
$ |
18,770 |
|
|
$ |
17,177 |
|
|
$ |
42,130 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
% of Sales |
|
|
4 |
% |
|
|
13 |
% |
|
|
12 |
% |
|
|
30 |
% |
% Increase (Decrease) |
|
|
2 |
% |
|
|
10 |
% |
|
|
3 |
% |
|
|
6 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fiscal 2009
Increases
(Decreases): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
US Diagnostics |
|
|
2,331 |
|
|
|
930 |
|
|
|
(732 |
) |
|
|
2,529 |
|
European Diagnostics |
|
|
|
|
|
|
(321 |
) |
|
|
(20 |
) |
|
|
(341 |
) |
Life Science |
|
|
(86 |
) |
|
|
(144 |
) |
|
|
(84 |
) |
|
|
(314 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2009 Expenses |
|
$ |
8,428 |
|
|
$ |
19,235 |
|
|
$ |
16,341 |
|
|
$ |
44,004 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
% of Sales |
|
|
6 |
% |
|
|
13 |
% |
|
|
11 |
% |
|
|
30 |
% |
% Increase (Decrease) |
|
|
36 |
% |
|
|
2 |
% |
|
|
-5 |
% |
|
|
4 |
% |
Operating expenses for the US Diagnostics operating segment increased $2,529 for fiscal 2009
compared to fiscal 2008 and $1,537 for fiscal 2008 compared to fiscal 2007. Increases in both
years were primarily attributable to development costs for our molecular C. difficile product and
additional salaries and benefits related to planned headcount additions. The fiscal 2009 period
also saw increased marketing and clinical trial expenses related to new products. These increases
were partially offset by decreased stock based compensation and decreased corporate incentive bonus
related to earnings achieved for fiscal 2009 and attainment of lower level bonus targets in fiscal
2008 compared to fiscal 2007. No corporate incentive bonus has been recorded for salaried
employees for fiscal 2009.
Operating expenses for the European Diagnostics operating segment decreased $341 for fiscal 2009
compared to fiscal 2008 and increased $812 for fiscal 2008 compared to fiscal 2007. The
fluctuations for fiscal 2009 and fiscal 2008 were primarily attributable to currency fluctuations.
- 30 -
Operating expenses for the Life Science Operating segment decreased $314 for fiscal 2009 compared
to fiscal 2008 and decreased $129 for fiscal 2008 compared to fiscal 2007. The fiscal 2009
decrease was primarily attributable to reduced salaries and benefits related to lower headcount.
The amount of stock-based compensation expense reported for fiscal 2009, fiscal 2008, and fiscal
2007 was $1,092, $1,772, and $2,632, respectively. During November 2007 and November 2008, we
granted to certain employees stock options and restricted stock that were contingent upon Meridian
achieving a specified net earnings level for each fiscal year. Because Meridians fiscal net
earnings did not reach the minimum level in 2008 or 2009, these awards were not earned. No
stock-based compensation has been recorded for these awards. Similarly, during November 2006, we
granted to certain employees stock options that were contingent upon Meridian achieving a specified
net earnings level for fiscal 2007. Because Meridians fiscal 2007 net earnings surpassed the
minimum level, these stock options were earned and are now exercisable over a vesting period.
Operating Income
Operating income increased 10% and 27% in fiscal 2009 and 2008, respectively, as a result of the
factors discussed above.
Other Income and Expense
Interest income was $456, $1,533, and $1,642 for fiscal 2009, 2008, and 2007, respectively. The
decreases during fiscal 2009 and fiscal 2008 were driven by lower interest yields due to a higher
concentration of investments in money market funds in fiscal 2009 and lower interest rates in the
current interest rate environment, somewhat offset by higher average investment balances.
Income Taxes
The effective rate for income taxes was 34%, 34%, and 27% for fiscal 2009, 2008, and 2007,
respectively. The increase in the effective tax rate for fiscal 2008 was primarily attributable to
a discrete adjustment to tax reserves in the third quarter of fiscal 2007 in the amount of $2,425.
This discrete adjustment reduced the effective tax rate for fiscal 2007 by 7 points.
Impact of Inflation
To the extent feasible, we have consistently followed the practice of adjusting our prices to
reflect the impact of inflation on salaries and fringe benefits for employees and the cost of
purchased materials and services. Inflation and changing prices did not have a material adverse
impact our gross margin, revenue or operating income in fiscal 2009, 2008 or 2007.
- 31 -
Liquidity and Capital Resources:
Comparative Cash Flow Analysis
Our cash flow and financing requirements are determined by analyses of operating and capital
spending budgets, consideration of acquisition plans, and consideration of common share dividends.
We have historically maintained a credit facility to augment working capital requirements and to
respond quickly to acquisition opportunities. This credit facility has been supplemented by the
proceeds from a September 2005 common share offering, which during most of fiscal 2009, were
invested in a non-interest bearing bank deposit account, overnight repurchase agreements,
institutional money-market mutual funds and tax-exempt auction-rate securities.
We have an investment policy that guides the holdings of our investment portfolio. Our objectives
in managing the investment portfolio are to (i) preserve capital, (ii) provide sufficient liquidity
to meet working capital requirements and fund strategic objectives such as acquisitions, and (iii)
capture a market rate of return commensurate with market conditions and our policys investment
eligibility criteria. As a result of conditions in the financial markets, we have chosen to keep
the maturity of our investment portfolio very short. As we look forward, we will continue to
manage the holdings of our investment portfolio with preservation of capital being the primary
objective.
Except as otherwise described herein, we do not expect current conditions in the financial markets,
or overall economic conditions to have a significant impact on our liquidity needs, financial
condition, or results of operations. We intend to continue to fund our working capital
requirements and dividends from current cash flows from operating activities. We also have
additional sources of liquidity through our investment portfolio and $30,000 bank credit facility,
if needed. To date, we have not experienced any significant deterioration in the aging of our
customer accounts receivable nor in our vendors ability to supply raw materials and services and
extend normal credit terms. Our liquidity needs may change if overall economic conditions worsen
and/or liquidity and credit within the financial markets remains tight for an extended period of
time, and such conditions impact the collectability of our customer accounts receivable, or impact
credit terms with our vendors, or disrupt the supply of raw materials and services.
Overall stock market valuations declined early in fiscal 2009 only to rebound in the latter part of
the year. These fluctuations may raise questions as to the potential impairment of goodwill and
other long-lived assets. Our annual goodwill impairment review takes place as of June
30th each year. There have been no impairments from these annual reviews. Despite the
overall decline in stock market valuations, as of October 31, 2009, our stock price was $22.19 per
share, compared to our book value per share of $3.40 as of September 30, 2009. This relationship,
stock price trading at 6.5x book value, is an indicator that the decline in overall stock market
valuations, and its impact on our stock price, has not been a triggering event for impairment of
our goodwill and other long-lived assets.
- 32 -
Net cash provided by operating activities increased 9% to $32,492 in fiscal 2009. This
increase was primarily attributable to higher earnings levels and timing of payments with
suppliers.
Net cash used for investing activities was $3,280 for fiscal 2009 compared to $13,230 for fiscal
2008. This decrease was primarily attributable to reduced purchases of property, plant, and
equipment in fiscal 2009, changes in our investment portfolio during fiscal 2009 and 2008,
including purchases of auction-rate securities in fiscal 2008, and purchases of intangible assets
related to patents and an acquired recombinant viral protein product line in fiscal 2008.
Net cash used for financing activities was $24,636 for fiscal 2009 compared to $16,693 for fiscal
2008. This increase was primarily attributable to a 24% increase in dividend payments and a
decrease of $2,939 in proceeds and tax benefits from the exercise of stock options. Dividend
payments in fiscal 2009 reflect increased dividend rates and common shares outstanding related to
stock option exercises.
Net cash flows from operating activities are anticipated to fund working capital requirements and
dividends during the next twelve months.
Capital Resources
We have a $30,000 credit facility with a commercial bank which expires September 15, 2012. As of
November 26, 2009, there were no borrowings outstanding under this facility. We did not have any
borrowing under this facility during fiscal 2009 or 2008.
Our capital expenditures are estimated to be approximately $5,000 for fiscal 2010, and
may be funded with cash and equivalents on hand, operating cash flows, and/or availability under
the $30,000 credit facility discussed above. Capital expenditures relate to manufacturing and
other equipment of a normal and recurring nature, as well as the build out of the recently
purchased property in the Village of Newtown.
Student Loan Auction-Rate Securities
Our investment portfolio includes student loan auction-rate securities, which are long-term student
loan revenue bonds whose interest rates are reset every 35 days via a Dutch auction process. All
of our auction-rate securities are backed by pools of student loans originated under the Federal
Family Education Loan Program (FFELP). FFELP student loans are guaranteed by State guarantors who
have reinsurance agreements with the US Department of Education. All of our student loan
auction-rate securities were rated Aaa and AAA by Moodys
and Standard & Poors, respectively, at the time of purchase, and have continued to maintain these
credit ratings through the present time.
- 33 -
The Dutch auction process historically provided the necessary liquidity mechanism to either
purchase or sell these securities. Beginning in mid-February 2008, liquidity issues in the US
credit markets resulted in the failure of auctions across a broad spectrum of tax-exempt
securities, including student loan revenue bonds. Auctions for the student loan revenue bonds that
we hold have continued to fail through the present time. The consequence of a failed auction is
that we do not have access to the principal amount of our investments. Issuers are still required
to make interest payments when due in the event of failed auctions. We have not experienced any
missed interest payments to date.
Our auction-rate securities were purchased through UBS Financial Services, Inc. During November
2008, we accepted an offer from UBS, AG (UBS) of Auction Rate Security Rights. These rights permit
us to require UBS between June 30, 2010 and July 2, 2012 (the exercise period) to purchase our
auction-rate securities at par value. In exchange, UBS is granted the right, at their sole
discretion, to sell or otherwise dispose of our auction-rate security investments until July 2,
2012 as long as we receive a payment of par value upon the sale or disposition. In addition, the
rights permit us to establish a demand revolving credit line in an amount equal to the par value of
the securities at a net no cost. We are still able to sell the auction-rate securities on our own,
but in such a circumstance, we would lose the par value support from UBS.
Upon executing the settlement agreement with UBS, we recognized the Auction Rate Security Rights as
a stand-alone financial instrument and elected the fair value option. We also transferred the
student loan auction-rate securities from the available-for-sale classification, to the trading
classification. Upon transfer to the trading classification, $270 in unrealized losses as of
September 30, 2008, were transferred from accumulated other comprehensive income to other income
and expense. Adjustments to the fair value of student loan auction-rate securities and Auction
Rate Security Rights are recorded to other income and expense in each accounting period. As of
September 30, 2009, the fair value of the student-loan auction rate securities was $6,708 compared
to a par value of $7,275. As of September 30, 2009, the fair value of the Auction Rate Security
Rights was $577. The student loan auction-rate securities and Auction Rate Security Rights are
included in current assets in the accompanying consolidated balance sheet based on the earliest
exercise date of June 30, 2010.
- 34 -
Known Contractual Obligations:
Known contractual obligations and their related due dates were as follows as of September 30, 2009:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Less than 1 |
|
|
|
|
|
|
|
|
|
|
More than 5 |
|
|
|
Total |
|
|
Year |
|
|
1-3 Years |
|
|
4-5 Years |
|
|
Years |
|
Operating leases (1) |
|
$ |
1,489 |
|
|
$ |
610 |
|
|
$ |
749 |
|
|
$ |
130 |
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Purchase obligations (2) |
|
|
13,688 |
|
|
|
12,917 |
|
|
|
771 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Uncertain income tax
positions liability and
interest (3) |
|
|
572 |
|
|
|
572 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
15,749 |
|
|
$ |
14,099 |
|
|
$ |
1,520 |
|
|
$ |
130 |
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
Meridian and its subsidiaries are lessees of (i) office and warehouse buildings in Cincinnati,
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) |
|
As of September 30, 2009, our liabilities for uncertain tax positions and related interest and
penalties were $470 and $102, respectively. Due to inherent uncertainties in the timing of settlement
of tax positions, we are unable to estimate the timing of the effective settlement of these
obligations. |
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 $696 in fiscal 2010. These royalty payments primarily
relate to the US Diagnostics operating segment.
Meridian entered into a license agreement in October 2006 with a third party that provides rights
to a molecular technology for infectious disease testing in the United States, Europe and other
geographic markets. The agreement, as amended during fiscal 2009, calls for payments of up to
approximately $800 based on the achievement of certain product development milestones and on-going
royalties once products are available for commercial sale. Payments made during product
development are expected to occur over a five-year period, which began in fiscal 2007. Payments
of $104, $0 and $169 were made during fiscal 2009, fiscal 2008 and fiscal 2007, respectively,
related to this license.
- 35 -
During the fourth quarter of fiscal 2007, we began seeking recovery of approximately $1,400 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
Prior to February 1, 2009, we managed exchange rate risk related to forecasted intercompany sales
denominated in the Euro currency through the use of forward exchange contracts. We designated such
forward contracts as cash flow hedges. As such, the effective portion of the gain or loss on the
derivative instrument was reported as a component of other comprehensive income and reclassified
into earnings in the same period or periods during which the hedged transaction affected earnings.
As of September 30, 2009, we had no such contracts outstanding.
During January 2009, 500 notional amount of these contracts were settled in accordance with their
original maturities. The realized gain on these contracts was $32. Also during January 2009, we
accelerated the settlement of the remaining 2,700 notional amount of forward exchange contracts
that were originally scheduled to mature between February 27, 2009 and December 31, 2009. These
transactions resulted in a gain of approximately $140 that was recorded in the second quarter of
fiscal 2009. We unwound these forward exchange contracts after completing a strategic review of
our foreign currency exposures.
Off-balance sheet arrangements
We have no off-balance sheet arrangements.
Market Risk Exposure:
Foreign Currency Risk
We have market risk exposure related to foreign currency transactions. We are exposed to foreign
currency risk related to our European distribution operations where the billing currency is the
Euro for most of our customers in these markets. We also are exposed to foreign currency risk
related to the supply of certain diagnostic test kits by manufacturers located in Germany and
Spain. These foreign currency risks are opposite one another, providing a natural hedge with
respect to consolidated gross profit and operating income.
- 36 -
Concentration of Customers/Products Risk
Our US Diagnostic operating segments sales through two distributors were 58% of the US Diagnostics
operating segments total sales or 38% of consolidated sales for fiscal 2009. Three internally
developed products, PremierTM Platinum HpSA PLUS, PremierTM Toxins A&B, and
ImmunoCard® Toxins A&B, accounted for 35% of our US Diagnostics operating segments
third-party sales during fiscal 2009. These same three products accounted for 39% of our European
Diagnostics operating segments third-party sales and 30% of our consolidated sales for fiscal
2009.
Our Life Science operating segments sales of purified antigens and reagents to two customers were
30% of the Life Science operating segments total sales for fiscal 2009 or 5% of our consolidated
sales for fiscal 2009. Our Life Science operating segment has two other significant customers who
purchase antigens, antibodies and reagents, which together comprised 5% of the operating segments
total sales for fiscal 2009.
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 our products. We estimate rebate accruals
based on historical statistics, current trends, and other factors. Changes to these rebate
accruals are recorded in the period that they become known.
Life Science revenue for contract services may come from standalone arrangements for process
development and/or optimization work (contract research and development services) or custom
manufacturing, or multiple-deliverable arrangements that include process development work followed
by larger-scale manufacturing (both contract research and development services and contract
manufacturing services). Revenue is recognized based on the nature of the arrangements, with each
of the multiple
- 37 -
deliverables in a given arrangement having distinct
and separate fair values. Fair values are determined via consistent pricing between standalone
arrangements and multiple deliverable arrangements, as well as a competitive bidding process.
Contract research and development services may be performed on a time and materials basis or
fixed fee basis. For time and materials arrangements, revenue is recognized as services are
performed and billed. For fixed fee arrangements, revenue is recognized upon completion and
acceptance by the customer. For contract manufacturing services, revenue is generally recognized
upon delivery of product and acceptance by the customer. In some cases, customers may request that
we store on their behalf clinical grade biologicals that we produce under contract manufacturing
agreements. These cases arise when customers do not have clinical grade storage facilities or do
not want to risk contamination during transport. For such cases, revenue may be recognized on a
bill-and-hold basis pursuant to the satisfaction of criteria in SEC Staff Accounting Bulletins Nos.
101 and 104 related to bill-and-hold revenue recognition.
Inventories
Our inventories are carried at the lower of cost or market. Cost is determined on a first-in,
first-out basis. We establish reserves against cost for excess and obsolete materials, finished
goods whose shelf life may expire before sale to customers, and other identified exposures.
Management estimates these reserves based on assumptions about future demand and market conditions.
If actual demand and market conditions were to be less favorable than such estimates, additional
inventory write-downs would be required and recorded in the period known. Such adjustments would
negatively affect gross profit margin and overall results of operations.
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.
Goodwill is 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 these analyses.
Identifiable intangibles with finite lives are subject to impairment testing. Identifiable
intangibles with finite lives are reviewed for impairment when events or circumstances indicate
that such assets may not be recoverable at their current carrying value. Whether an event or
circumstance triggers impairment is determined by comparing an estimate of the assets undiscounted
future cash flows to its carrying value. If impairment has occurred, it is measured by a
fair-value based test. There were no events or circumstances in fiscal 2009, 2008 or 2007
indicating that the carrying value of such assets may not be recoverable.
- 38 -
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. Management is required
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
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
purposes 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 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. We believe that such US taxes would be largely offset by foreign tax credits
for taxes paid locally in Italy.
From time to time, our tax returns in federal, state, and foreign jurisdictions are examined by the
applicable tax authorities. To the extent that adjustments result from the completion of these
examinations or the lapsing of statutes of limitation, they will affect tax liabilities in the
period known. We believe that the results of any tax authority examinations would not have a
significant adverse impact on financial condition or results of operation.
- 39 -
Fair Value Measurements
We adopted the fair value measurement as prescribed by FASB on October 1, 2008 to value our
financial assets and liabilities. Fair value is the price that would be received to sell an asset
or paid to transfer a liability in an orderly transaction between market participants at the
measurement date. In order to increase consistency and comparability in fair value measurements
and related disclosures, a fair value hierarchy has been established by FASB that prioritizes
inputs to valuation techniques used to measure fair value into three broad levels, which are
described below:
Level 1: Quoted prices (unadjusted) in active markets for identical assets or liabilities that are
accessible at the measurement date for assets and liabilities. The fair value hierarchy gives the
highest priority to Level 1 inputs.
Level 2: Inputs other than quoted prices included within Level 1 that are observable for the assets
or liabilities, either directly or indirectly. These include quoted prices for identical or
similar assets or liabilities in markets that are not active, that is, markets in which there are
few transactions for the asset or liability, the prices are not current, or price quotations vary
substantially either over time or among market makers, or in which little information is released
publicly and inputs that are derived principally from or corroborated by observable market data by
correlation or other means.
Level 3: Unobservable inputs, developed using the Companys estimates and assumptions, which
reflect those that the market participants would use. Such inputs are used when little or no
market data is available. The fair value hierarchy gives the lowest priority to Level 3 inputs.
Determining where an asset or liability falls within the hierarchy depends on the lowest level
input that is significant to the fair value measurement as a whole. In determining fair value, we
utilize valuation techniques that maximize the use of observable inputs and minimize the use of
unobservable inputs to the extent possible and consider counterparty credit risk in the assessment
of fair value.
The failed auction status and lack of liquidity for our student loan auction-rate securities and
the non-transferability of our UBS Auction Rate Security Rights requires the use of a valuation
methodology that relies exclusively on Level 3 inputs including market, tax status, credit quality,
duration, recent market observations and overall capital market liquidity. The valuation of our
student loan auction-rate securities and UBS Auction Rate Security Rights is subject to
uncertainties that are difficult to predict. Factors that may impact the valuations include
changes to credit ratings of the securities as well as to the underlying assets supporting those
securities, rates of default of the underlying assets, underlying collateral value, discount rates,
counterparty risk and ongoing strength and quality of market credit and liquidity.
- 40 -
Recent Accounting Pronouncements:
See Note 1 (p) 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.
- 41 -
ITEM 8.
FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
Index to Consolidated Financial Statements
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.
- 42 -
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 of compliance with the policies or
procedures may deteriorate.
Under the supervision and with the participation of our management, including the Chief Executive
Officer and the Chief Financial Officer, we conducted an evaluation of the effectiveness of our
internal control over financial reporting 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, 2009.
The companys independent registered public accounting firm has issued an attestation report on the
registrants internal control over financial reporting.
|
|
|
|
|
|
/s/ John A. Kraeutler
|
|
|
Chief Executive Officer |
|
|
November 30, 2009 |
|
|
|
|
|
/s/ Melissa Lueke
|
|
|
Melissa Lueke |
|
|
Executive Vice President and
Chief Financial Officer November 30, 2009 |
|
- 43 -
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
Board of Directors and Shareholders
Meridian Bioscience, Inc.
We have audited the accompanying consolidated balance sheets of Meridian Bioscience, Inc (an Ohio
corporation) and subsidiaries as of September 30, 2009 and 2008, and the related consolidated
statements of operations, shareholders equity, and cash flows for each of the three years in the
period ended September 30, 2009. Our audits of the basic financial statements included the
financial statement schedule listed in the index appearing under Schedule No. II. We also have
audited Meridian Bioscience, Inc.s internal control over financial reporting as of September 30,
2009, based on criteria established in Internal ControlIntegrated Framework issued by the
Committee of Sponsoring Organizations of the Treadway Commission (COSO). Meridian Bioscience,
Inc.s management is responsible for these financial statements
and financial statement schedule, for maintaining effective internal
control over financial reporting, and for its assessment of the effectiveness of internal control
over financial reporting, included in the accompanying Managements Report on Internal Control over
Financial Reporting. Our responsibility is to express an opinion on
these financial statements and financial statement schedule and
an opinion on 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.
- 44 -
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,
2009 and 2008, and the results of their operations and their cash flows for each of the three years
in the period ended September 30, 2009 in conformity with accounting principles generally accepted
in the United States of America. Also in our opinion, the related financial statement schedule,
when considered in relation to the basic financial statements taken as a whole, presents fairly, in
all material respects, the information set forth therein.
In our opinion, Meridian Bioscience, Inc. and subsidiaries, maintained, in all material
respects, effective internal control over financial reporting as of September 30, 2009, based on
criteria established in Internal ControlIntegrated Framework issued by COSO.
We do not express an opinion or any other form of assurance on Managements Report on Internal
Control over Financial Reporting.
/s/ GRANT THORNTON
Cincinnati, Ohio
November 30, 2009
- 45 -
CONSOLIDATED STATEMENTS OF OPERATIONS (in thousands, except per share data)
Meridian Bioscience, Inc. and Subsidiaries
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Year Ended September 30, |
|
2009 |
|
|
2008 |
|
|
2007 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Sales |
|
$ |
148,274 |
|
|
$ |
139,639 |
|
|
$ |
122,963 |
|
Cost of Sales |
|
|
55,491 |
|
|
|
53,159 |
|
|
|
48,023 |
|
|
|
|
|
|
|
|
|
|
|
Gross Profit |
|
|
92,783 |
|
|
|
86,480 |
|
|
|
74,940 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating Expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
8,428 |
|
|
|
6,183 |
|
|
|
6,085 |
|
Selling and marketing |
|
|
19,235 |
|
|
|
18,770 |
|
|
|
17,124 |
|
General and administrative |
|
|
16,341 |
|
|
|
17,177 |
|
|
|
16,701 |
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
|
44,004 |
|
|
|
42,130 |
|
|
|
39,910 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating Income |
|
|
48,779 |
|
|
|
44,350 |
|
|
|
35,030 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other Income (Expense): |
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
456 |
|
|
|
1,533 |
|
|
|
1,642 |
|
Interest expense |
|
|
|
|
|
|
|
|
|
|
(38 |
) |
Other, net |
|
|
88 |
|
|
|
109 |
|
|
|
48 |
|
|
|
|
|
|
|
|
|
|
|
Total other income |
|
|
544 |
|
|
|
1,642 |
|
|
|
1,652 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Earnings Before Income Taxes |
|
|
49,323 |
|
|
|
45,992 |
|
|
|
36,682 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income Tax Provision |
|
|
16,564 |
|
|
|
15,790 |
|
|
|
9,961 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Earnings |
|
$ |
32,759 |
|
|
$ |
30,202 |
|
|
$ |
26,721 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Earnings Per Share Data: |
|
|
|
|
|
|
|
|
|
|
|
|
Basic earnings per common share |
|
$ |
0.81 |
|
|
$ |
0.75 |
|
|
$ |
0.67 |
|
Diluted earnings per common share |
|
$ |
0.80 |
|
|
$ |
0.74 |
|
|
$ |
0.66 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common shares used for basic earnings
per common share |
|
|
40,390 |
|
|
|
40,093 |
|
|
|
39,584 |
|
|
Effect of dilutive stock options |
|
|
720 |
|
|
|
936 |
|
|
|
1,154 |
|
|
|
|
|
|
|
|
|
|
|
Common shares used for diluted earnings
per common share |
|
|
41,110 |
|
|
|
41,029 |
|
|
|
40,738 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dividends declared per common share |
|
$ |
0.65 |
|
|
$ |
0.53 |
|
|
$ |
0.40 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Anti-dilutive Securities: |
|
|
|
|
|
|
|
|
|
|
|
|
Common share options |
|
|
138 |
|
|
|
67 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these consolidated financial statements.
- 46 -
CONSOLIDATED STATEMENTS OF CASH FLOWS (dollars in thousands)
Meridian Bioscience, Inc. and Subsidiaries
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Year Ended September 30, |
|
2009 |
|
|
2008 |
|
|
2007 |
|
Cash Flows From Operating Activities |
|
|
|
|
|
|
|
|
|
|
|
|
Net earnings |
|
$ |
32,759 |
|
|
$ |
30,202 |
|
|
$ |
26,721 |
|
Non-cash items: |
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation of property, plant and equipment |
|
|
2,781 |
|
|
|
2,857 |
|
|
|
2,764 |
|
Amortization of intangible assets |
|
|
1,579 |
|
|
|
1,612 |
|
|
|
1,635 |
|
Stock based compensation |
|
|
1,092 |
|
|
|
1,772 |
|
|
|
2,632 |
|
Deferred income taxes |
|
|
(500 |
) |
|
|
976 |
|
|
|
800 |
|
Tax reserve adjustment |
|
|
|
|
|
|
|
|
|
|
(2,425 |
) |
Loss on disposition of fixed assets |
|
|
109 |
|
|
|
9 |
|
|
|
5 |
|
Unrealized gain on auction-rate securities and rights, net |
|
|
(10 |
) |
|
|
|
|
|
|
|
|
Change in accounts receivable, inventory, and prepaid expenses |
|
|
(5,353 |
) |
|
|
(5,147 |
) |
|
|
(3,011 |
) |
Change in accounts payable, accrued expenses, and income
taxes payable |
|
|
269 |
|
|
|
(2,967 |
) |
|
|
(2,145 |
) |
Other, net |
|
|
(234 |
) |
|
|
569 |
|
|
|
(374 |
) |
|
|
|
|
|
|
|
|
|
|
Net cash provided by operating activities |
|
|
32,492 |
|
|
|
29,883 |
|
|
|
26,602 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash Flows From Investing Activities |
|
|
|
|
|
|
|
|
|
|
|
|
Acquisition earnout payments |
|
|
(7 |
) |
|
|
(157 |
) |
|
|
(971 |
) |
Purchases of property, plant and equipment |
|
|
(3,643 |
) |
|
|
(4,219 |
) |
|
|
(3,211 |
) |
Proceeds from dispositions of property, plant and equipment |
|
|
5 |
|
|
|
4 |
|
|
|
4 |
|
Purchases of investments |
|
|
|
|
|
|
(7,750 |
) |
|
|
|
|
Proceeds from sales of investments |
|
|
475 |
|
|
|
|
|
|
|
4,000 |
|
Purchases of intangibles and other assets |
|
|
(110 |
) |
|
|
(1,108 |
) |
|
|
(265 |
) |
|
|
|
|
|
|
|
|
|
|
Net cash used for investing activities |
|
|
(3,280 |
) |
|
|
(13,230 |
) |
|
|
(443 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash Flows From Financing Activities |
|
|
|
|
|
|
|
|
|
|
|
|
Repayment of debt obligations |
|
|
|
|
|
|
|
|
|
|
(29 |
) |
Dividends paid |
|
|
(26,260 |
) |
|
|
(21,256 |
) |
|
|
(15,836 |
) |
Proceeds and tax benefits from exercises of stock options |
|
|
1,624 |
|
|
|
4,563 |
|
|
|
2,574 |
|
|
|
|
|
|
|
|
|
|
|
Net cash used for financing activities |
|
|
(24,636 |
) |
|
|
(16,693 |
) |
|
|
(13,291 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Effect of Exchange Rate Changes on Cash and Equivalents |
|
|
157 |
|
|
|
(63 |
) |
|
|
184 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Increase in Cash and Equivalents |
|
|
4,733 |
|
|
|
(103 |
) |
|
|
13,052 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and Equivalents at Beginning of Period |
|
|
49,297 |
|
|
|
49,400 |
|
|
|
36,348 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and Equivalents at End of Period |
|
$ |
54,030 |
|
|
$ |
49,297 |
|
|
$ |
49,400 |
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these consolidated financial statements.
- 47 -
CONSOLIDATED BALANCE SHEETS (dollars in thousands)
Meridian Bioscience, Inc. and Subsidiaries
|
|
|
|
|
|
|
|
|
As of September 30, |
|
2009 |
|
|
2008 |
|
Assets |
|
|
|
|
|
|
|
|
Current Assets: |
|
|
|
|
|
|
|
|
Cash and equivalents |
|
$ |
54,030 |
|
|
$ |
49,297 |
|
Investment in auction-rate securities and rights |
|
|
7,285 |
|
|
|
|
|
Accounts receivable, less allowances of $247 in
2009 and $230 in 2008 |
|
|
26,981 |
|
|
|
25,098 |
|
Inventories |
|
|
23,284 |
|
|
|
19,945 |
|
Prepaid expenses and other current assets |
|
|
3,632 |
|
|
|
3,382 |
|
Deferred income taxes |
|
|
1,935 |
|
|
|
1,736 |
|
|
|
|
|
|
|
|
Total current assets |
|
|
117,147 |
|
|
|
99,458 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Property, Plant and Equipment, at Cost: |
|
|
|
|
|
|
|
|
Land |
|
|
894 |
|
|
|
892 |
|
Buildings and improvements |
|
|
19,718 |
|
|
|
16,977 |
|
Machinery, equipment and furniture |
|
|
30,997 |
|
|
|
26,458 |
|
Construction in progress |
|
|
1,586 |
|
|
|
3,391 |
|
|
|
|
|
|
|
|
Subtotal |
|
|
53,195 |
|
|
|
47,718 |
|
Less: accumulated depreciation and amortization |
|
|
32,721 |
|
|
|
28,043 |
|
|
|
|
|
|
|
|
Net property, plant and equipment |
|
|
20,474 |
|
|
|
19,675 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other Assets: |
|
|
|
|
|
|
|
|
Goodwill |
|
|
9,866 |
|
|
|
9,861 |
|
Other intangible assets, net |
|
|
7,317 |
|
|
|
8,786 |
|
Restricted cash |
|
|
1,000 |
|
|
|
1,000 |
|
Investments in auction-rate securities and rights |
|
|
|
|
|
|
7,480 |
|
Other assets |
|
|
193 |
|
|
|
171 |
|
|
|
|
|
|
|
|
Total other assets |
|
|
18,376 |
|
|
|
27,298 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets |
|
$ |
155,997 |
|
|
$ |
146,431 |
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these consolidated financial statements.
- 48 -
CONSOLIDATED BALANCE SHEETS (dollars in thousands)
Meridian Bioscience, Inc. and Subsidiaries
|
|
|
|
|
|
|
|
|
As of September 30, |
|
2009 |
|
|
2008 |
|
Liabilities and Shareholders Equity |
|
|
|
|
|
|
|
|
Current Liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
6,901 |
|
|
$ |
4,777 |
|
Accrued employee compensation costs |
|
|
5,338 |
|
|
|
6,777 |
|
Other accrued expenses |
|
|
3,803 |
|
|
|
3,616 |
|
Income taxes payable |
|
|
710 |
|
|
|
891 |
|
|
|
|
|
|
|
|
Total current liabilities |
|
|
16,752 |
|
|
|
16,061 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deferred Income Taxes |
|
|
1,340 |
|
|
|
1,881 |
|
|
|
|
|
|
|
|
|
|
Commitments and Contingencies |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shareholders Equity: |
|
|
|
|
|
|
|
|
Preferred stock, no par value, 1,000,000 shares authorized, none issued |
|
|
|
|
|
|
|
|
Common shares, no par value, 71,000,000 shares authorized, 40,493,313
and 40,313,656 issued |
|
|
|
|
|
|
|
|
Additional paid-in capital |
|
|
91,668 |
|
|
|
89,107 |
|
Retained earnings |
|
|
45,515 |
|
|
|
39,016 |
|
Accumulated other comprehensive income |
|
|
722 |
|
|
|
366 |
|
|
|
|
|
|
|
|
Total shareholders equity |
|
|
137,905 |
|
|
|
128,489 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities and shareholders equity |
|
$ |
155,997 |
|
|
$ |
146,431 |
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these consolidated financial statements.
- 49 -
CONSOLIDATED STATEMENTS OF SHAREHOLDERS EQUITY (Dollars and shares in thousands except per share data)
Meridian Bioscience, Inc. and Subsidiaries
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accum Other |
|
|
|
|
|
|
|
|
|
Common |
|
|
Additional |
|
|
|
|
|
|
Comp |
|
|
Comp |
|
|
|
|
|
|
Shares |
|
|
Paid-in |
|
|
Retained |
|
|
Income |
|
|
Income |
|
|
|
|
|
|
Issued |
|
|
Capital |
|
|
Earnings |
|
|
(Loss) |
|
|
(Loss) |
|
|
Total |
|
Balance at September 30, 2006 |
|
|
39,236 |
|
|
$ |
74,950 |
|
|
$ |
19,490 |
|
|
$ |
(90 |
) |
|
|
|
|
|
$ |
94,350 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash dividends paid $0.40 per share |
|
|
|
|
|
|
|
|
|
|
(15,836 |
) |
|
|
|
|
|
|
|
|
|
|
(15,836 |
) |
Exercise of stock options |
|
|
336 |
|
|
|
2,950 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,950 |
|
Stock compensation expense |
|
|
|
|
|
|
2,632 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,632 |
|
Debenture conversions |
|
|
275 |
|
|
|
1,677 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,677 |
|
Comprehensive income: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net earnings |
|
|
|
|
|
|
|
|
|
|
26,721 |
|
|
|
|
|
|
$ |
26,721 |
|
|
|
26,721 |
|
Hedging activity, net |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(283 |
) |
|
|
(283 |
) |
|
|
(283 |
) |
Other comprehensive income taxes |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(244 |
) |
|
|
(244 |
) |
|
|
(244 |
) |
Foreign currency translation adjustment |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
981 |
|
|
|
981 |
|
|
|
981 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
27,175 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at September 30, 2007 |
|
|
39,847 |
|
|
|
82,209 |
|
|
|
30,375 |
|
|
|
364 |
|
|
|
|
|
|
|
112,948 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Adoption of FASB Interpretation No. 48 |
|
|
|
|
|
|
|
|
|
|
(305 |
) |
|
|
|
|
|
|
|
|
|
|
(305 |
) |
Cash dividends paid $0.53 per share |
|
|
|
|
|
|
|
|
|
|
(21,256 |
) |
|
|
|
|
|
|
|
|
|
|
(21,256 |
) |
Exercise of stock options |
|
|
467 |
|
|
|
5,126 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5,126 |
|
Stock compensation expense |
|
|
|
|
|
|
1,772 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,772 |
|
Comprehensive income: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net earnings |
|
|
|
|
|
|
|
|
|
|
30,202 |
|
|
|
|
|
|
$ |
30,202 |
|
|
|
30,202 |
|
Hedging activity, net |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
273 |
|
|
|
273 |
|
|
|
273 |
|
Unrealized loss on investments |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(270 |
) |
|
|
(270 |
) |
|
|
(270 |
) |
Other comprehensive income taxes |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(4 |
) |
|
|
(4 |
) |
|
|
(4 |
) |
Foreign currency translation adjustment |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3 |
|
|
|
3 |
|
|
|
3 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
30,204 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at September 30, 2008 |
|
|
40,314 |
|
|
|
89,107 |
|
|
|
39,016 |
|
|
|
366 |
|
|
|
|
|
|
|
128,489 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash dividends paid $0.65 per share |
|
|
|
|
|
|
|
|
|
|
(26,260 |
) |
|
|
|
|
|
|
|
|
|
|
(26,260 |
) |
Exercise of stock options |
|
|
180 |
|
|
|
1,476 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,476 |
|
Stock compensation expense |
|
|
|
|
|
|
1,092 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,092 |
|
Cost of S-8 registration statement |
|
|
|
|
|
|
(7 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(7 |
) |
Comprehensive income: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net earnings |
|
|
|
|
|
|
|
|
|
|
32,759 |
|
|
|
|
|
|
$ |
32,759 |
|
|
|
32,759 |
|
Hedging activity, net |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(3 |
) |
|
|
(3 |
) |
|
|
(3 |
) |
Transfer of investments to trading status |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
270 |
|
|
|
270 |
|
|
|
270 |
|
Other comprehensive income taxes |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(190 |
) |
|
|
(190 |
) |
|
|
(190 |
) |
Foreign currency translation adjustment |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
279 |
|
|
|
279 |
|
|
|
279 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
33,115 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at September 30, 2009 |
|
|
40,494 |
|
|
$ |
91,668 |
|
|
$ |
45,515 |
|
|
$ |
722 |
|
|
|
|
|
|
$ |
137,905 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these consolidated financial statements.
- 50 -
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Meridian Bioscience, Inc. and Subsidiaries
(dollars and shares in thousands, except per share data)
(1) Summary of Significant Accounting Policies
(a) |
|
Nature of Business Meridian is a fully-integrated life science company whose principal
businesses are (i) the development, manufacture and distribution of diagnostic test kits
primarily for certain respiratory, gastrointestinal, viral and parasitic infectious diseases,
(ii) the manufacture and distribution of bulk antigens, antibodies, and reagents used by
researchers and other diagnostic manufacturers and (iii) the contract development and
manufacture of proteins and other biologicals for use by biopharmaceutical and biotechnology
companies engaged in research for new drugs and vaccines. |
(b) |
|
Principles of Consolidation The consolidated financial statements include the accounts of
Meridian Bioscience, Inc. and its subsidiaries. All significant intercompany accounts and
transactions have been eliminated. Unless the context requires otherwise, references to
Meridian, we, us, our, or our company refer to Meridian Bioscience, Inc. and its
subsidiaries. |
(c) |
|
Use of Estimates The preparation of financial statements in conformity with generally
accepted accounting principles requires management to make estimates and assumptions that
affect the reported amounts of assets and liabilities, disclosure of contingent assets and
liabilities at the date of the financial statements and the reported amounts of revenues and
expenses during the reporting period. Actual results could differ from those estimates.
Significant estimates are discussed in Notes 1 (f), 1 (g), 1 (h), 1 (i), 1 (k), 1 (l), 6 and 7
(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 as a
separate component of accumulated other comprehensive income or loss. Revenues and expenses
are translated using exchange rates prevailing during the year. We also recognize foreign
currency transaction gains and losses on certain assets and liabilities that are denominated
in the Euro currency. These gains and losses are included in other income and expense in the
accompanying consolidated statements of operations. |
(e) |
|
Cash, Cash Equivalents and Investments The primary objectives of our investment activities
are to preserve capital and provide sufficient liquidity to meet operating requirements and
fund strategic initiatives such as acquisitions. We maintain a written investment policy that
governs the management of our investments in fixed income securities. This policy, among
other things, provides that we may purchase only high credit-quality securities, that have
short-term ratings |
- 51 -
|
|
of at least A-1 and P-1 or better, and long-term ratings of at least A-2 and A or better, by Moodys and Standard & Poors, respectively, at
the time of purchase. We consider short-term investments with original maturities of 90 days or
less to be cash equivalents, including overnight repurchase agreements, investments in municipal
variable rate demand notes that have a seven-day put feature and institutional money market
funds. Our investments in repurchase agreements at September 30, 2008 were with a commercial
bank pursuant to an overnight sweep/liquidity arrangement with our operating cash accounts. Our
investments in variable rate demand notes at September 30, 2008 contained a seven-day put
feature. |
|
|
Our investment portfolio includes the following components: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30, 2009 |
|
|
September 30, 2008 |
|
|
|
Cash and |
|
|
|
|
|
|
Cash and |
|
|
|
|
|
|
Equivalents |
|
|
Other |
|
|
Equivalents |
|
|
Other |
|
Taxable investments |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Repurchase agreements |
|
$ |
|
|
|
$ |
|
|
|
$ |
6,711 |
|
|
$ |
|
|
Money market funds |
|
|
29,032 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Tax-exempt investments |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Money market funds |
|
|
10,383 |
|
|
|
|
|
|
|
12,848 |
|
|
|
|
|
Variable rate demand notes |
|
|
|
|
|
|
|
|
|
|
23,948 |
|
|
|
|
|
Student loan auction-rate securities |
|
|
|
|
|
|
7,285 |
|
|
|
|
|
|
|
7,480 |
|
Cash on hand |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-interest bearing |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Restricted |
|
|
|
|
|
|
1,000 |
|
|
|
|
|
|
|
1,000 |
|
Unrestricted |
|
|
8,027 |
|
|
|
|
|
|
|
1,260 |
|
|
|
|
|
Interest bearing unrestricted |
|
|
6,588 |
|
|
|
|
|
|
|
4,530 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
54,030 |
|
|
$ |
8,285 |
|
|
$ |
49,297 |
|
|
$ |
8,480 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Our investments in tax-exempt variable rate demand notes, prior to their complete liquidation in
October 2008, and student loan auction-rate securities, prior to the settlement agreement with
UBS discussed below, were accounted for as available-for-sale. As such, unrealized holding
gains and losses were reported as a component of other comprehensive income or loss within
shareholders equity until realized, except where losses were considered to be
other-than-temporary, in which case they would have been recorded to other income and expense,
net. As of September 30, 2008, we did not have any losses that were considered
other-than-temporary, and accumulated other comprehensive income included $270 of unrealized
holding losses related to student loan auction-rate securities. |
|
|
Our investment portfolio includes student loan auction-rate securities, which are long-term
student loan revenue bonds whose interest rates are reset every 35 days via a Dutch auction
process. All of our auction-rate securities are backed by pools of student loans originated
under the Federal Family Education Loan Program (FFELP). FFELP student loans are guaranteed by
State guarantors who have reinsurance agreements with the US Department of Education. All of
our student loan auction-rate securities were rated
Aaa and AAA by Moodys and Standard & Poors, respectively, at the time of purchase, and have
continued to maintain these credit ratings through the present time. |
- 52 -
|
|
The Dutch auction process historically provided the necessary liquidity mechanism to either
purchase or sell these securities. Beginning in mid-February 2008, liquidity issues in the US
credit markets resulted in the failure of auctions across a broad spectrum of tax-exempt
securities, including student loan revenue bonds. Auctions for the student loan revenue bonds
that we hold have continued to fail through the present time. The consequence of a failed
auction is that we do not have access to the principal amount of our investments. Issuers are
still required to make interest payments when due in the event of failed auctions. We have not
experienced any missed interest payments to date. |
|
|
Our auction-rate securities were purchased through UBS Financial Services, Inc. During November
2008, we accepted an offer from UBS, AG (UBS) of Auction Rate Security Rights. These rights
permit us to require UBS between June 30, 2010 and July 2, 2012 (the exercise period) to
purchase our auction-rate securities at par value. In exchange, UBS is granted the right, at
their sole discretion, to sell or otherwise dispose of our auction-rate security investments
until July 2, 2012 as long as we receive a payment of par value upon the sale or disposition.
In addition, the rights permit us to establish a demand revolving credit line in an amount equal
to the par value of the securities at a net no cost. We are still able to sell the auction-rate
securities on our own, but in such a circumstance, we would lose the par value support from UBS. |
|
|
Upon executing the settlement agreement with UBS, we recognized the Auction Rate Security Rights
as a stand-alone financial instrument and elected the fair value option. We also transferred
the student loan auction-rate securities from the available-for-sale classification, to the
trading classification. Upon transfer to the trading classification, $270 in unrealized losses
as of September 30, 2008, were transferred from accumulated other comprehensive income to other
income and expense. Adjustments to the fair value of student loan auction-rate securities and
Auction Rate Security Rights are recorded to other income and expense in each accounting period.
As of September 30, 2009, the fair value of the student-loan auction rate securities was $6,708
compared to a par value of $7,275. As of September 30, 2009, the fair value of the Auction Rate
Security Rights was $577. The student loan auction-rate securities and Auction Rate Security
Rights are included in current assets in the accompanying consolidated balance sheet based on
the earliest exercise date of June 30, 2010. |
(f) |
|
Inventories Inventories are stated at the lower of cost or market. Cost is determined on a
first-in, first-out basis (FIFO) for substantially all of our inventories. |
|
|
We establish reserves against cost for excess and obsolete materials, finished goods whose shelf
life may expire before sale to customers, and other identified exposures. Such reserves were
$1,025 and $1,103 at September 30, 2009 and 2008, respectively. We estimate these reserves
based on assumptions about future
demand and market conditions. If actual demand and market conditions were to be less favorable
than such estimates, additional inventory write-downs would be required and recorded in the
period known. Such adjustments would negatively affect gross profit margin and overall results
of operations. |
- 53 -
(g) |
|
Property, Plant and Equipment Property, plant and equipment are stated at cost. Upon
retirement or other disposition of property, plant and equipment, the cost and related
accumulated depreciation are removed from the accounts and the resulting gain or loss is
reflected in earnings. Maintenance and repairs are expensed as incurred. Depreciation is
computed on the straight-line method in amounts sufficient to write-off the cost over the
estimated useful lives as follows: |
Buildings and improvements 18 to 40 years
Machinery, equipment, and furniture 3 to 10 years
(h) |
|
Intangible Assets 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. Fair value is determined via a market approach from three
perspectives. These three perspectives are (i) an allocation of our actual enterprise value
(defined as market capitalization plus debt) to each of the reporting units based on revenue
and EBITDA contributions to consolidated results; (ii) an allocation of implied enterprise
values to each of our reporting units based on average and median EBITDA multiples from a
comparable group of companies; and (iii) a review of enterprise value to EBITDA multiples from
recent industry merger and acquisition transactions. 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 these analyses for
fiscal 2009, 2008 or 2007. |
|
|
During fiscal 2009, the change in goodwill was an increase of $5. This change consisted of an
increase related to the OEM Concepts earnout obligations for calendar 2008 (Life Science
operating segment). During fiscal 2008, the change in goodwill was a decrease of $103. This
change consisted of an increase related to the OEM Concepts earnout obligations for calendar
2007 and the first nine months of calendar 2008 in the amount of $7 (Life Science operating
segment), offset by a decrease of $110 related to recognition of acquired tax benefits (US
Diagnostics operating segment). |
- 54 -
|
|
A summary of Meridians acquired intangible assets subject to amortization, as of September 30,
2009 and 2008 is as follows. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Wtd Avg |
|
|
2009 |
|
|
2009 |
|
|
2008 |
|
|
2008 |
|
|
|
Amort |
|
|
Gross |
|
|
|
|
|
|
Gross |
|
|
|
|
|
|
|
Period |
|
|
Carrying |
|
|
Accum. |
|
|
Carrying |
|
|
Accum. |
|
As of September 30, |
|
(Yrs) |
|
|
Value |
|
|
Amort. |
|
|
Value |
|
|
Amort. |
|
Core products and cell lines |
|
|
15 |
|
|
$ |
4,698 |
|
|
$ |
2,892 |
|
|
$ |
4,698 |
|
|
$ |
2,602 |
|
Manufacturing technologies |
|
|
14 |
|
|
|
6,057 |
|
|
|
4,780 |
|
|
|
6,057 |
|
|
|
4,440 |
|
Trademarks, licenses and patents |
|
|
8 |
|
|
|
2,772 |
|
|
|
1,974 |
|
|
|
2,663 |
|
|
|
1,843 |
|
Customer lists and supply
agreements |
|
|
13 |
|
|
|
11,040 |
|
|
|
7,604 |
|
|
|
11,039 |
|
|
|
6,786 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
24,567 |
|
|
$ |
17,250 |
|
|
$ |
24,457 |
|
|
$ |
15,671 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The actual aggregate amortization expense for these intangible assets for fiscal 2009,
2008, and 2007 was $1,579, $1,612, and $1,632, respectively. The estimated aggregate
amortization expense for these intangible assets for each of the five succeeding fiscal years is
as follows: fiscal 2010 $1,412, fiscal 2011 $1,298, fiscal 2012 $1,153, fiscal 2013-
$1,153 and fiscal 2014 $746. |
|
|
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. |
|
|
Our ability to recover our intangible assets, both identifiable intangibles and goodwill, is
dependent upon the future cash flows of the related acquired businesses and assets. We 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, we also make judgments and assumptions
regarding useful lives. |
|
|
We consider the following factors in evaluating events and circumstances for possible
impairment: (i) significant under-performance relative to historical or projected operating
results, (ii) negative industry trends, (iii) sales levels of specific groups of products
(related to specific identifiable intangibles), (iv) changes in overall business strategies and
(v) other factors. |
|
|
If actual cash flows are less favorable than projections, this could trigger impairment of
intangible assets and other long-lived assets. If impairment were to occur, this would
negatively affect overall results of operations. |
(i) |
|
Revenue Recognition Revenue is generally recognized from sales when product is shipped and
title has passed to the buyer. Revenue for the US Diagnostics operating segment is reduced at
the date of sale for estimated rebates that will be claimed by customers. Management
estimates accruals for rebate agreements based on historical statistics, current trends, and
other factors. Changes to the accruals are recorded in the
period that they become known. Our rebate accruals were $4,776 at September 30, 2009 and $3,259
at September 30, 2008. |
- 55 -
|
|
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, with each of the multiple deliverables in a given arrangement having distinct and
separate fair values. Fair values are determined via consistent pricing between standalone
arrangements and multiple deliverable arrangements, as well as a competitive bidding process.
Contract research and development services may be performed on a time and materials basis or
fixed fee basis. For time and materials arrangements, revenue is recognized as services are
performed and billed. For fixed fee arrangements, revenue is recognized upon completion and
acceptance by the customer. For contract manufacturing services, revenue is generally
recognized upon delivery of product and acceptance by the customer. In some cases, customers
may request that we store on their behalf, clinical grade biologicals that we produce under
contract manufacturing agreements. These cases arise when customers do not have clinical grade
storage facilities or do not want to risk contamination during transport. For such cases,
revenue may be recognized on a bill-and-hold basis pursuant to the satisfaction of criteria in
SEC Staff Accounting Bulletins Nos. 101 and 104 related to bill-and-hold revenue recognition. |
|
|
Trade accounts receivable are recorded in the accompanying consolidated balance sheet at
invoiced amounts less provisions for rebates and doubtful accounts. The allowance for doubtful
accounts represents our estimate of probable credit losses and is based on historical write-off
experience. The allowance for doubtful accounts and related metrics, such as days sales
outstanding, are reviewed monthly. Accounts with past due balances over 90 days are reviewed
individually for collectibility. Customer invoices are charged off against the allowance when
we believe it is probable the invoices will not be paid. |
(j) |
|
Research and Development Costs Research and development costs are charged to expense as
incurred. Research and development costs include, among other things, salaries and wages for
research scientists, materials and supplies used in the development of new products, costs for
development of instrumentation equipment, costs for clinical trials, and costs for facilities
and equipment. |
(k) |
|
Income Taxes The provision for income taxes includes federal, foreign, state, and local
income taxes currently payable and those deferred because of temporary differences between
income for financial reporting and income for tax purposes. We prepare estimates of permanent
and temporary differences between income for financial reporting purposes and income for tax
purposes. These differences are
adjusted to actual upon filing of our tax returns, typically occurring in the third and fourth
quarters of the current fiscal year for the preceding fiscal years estimates. |
- 56 -
|
|
We account for uncertain tax positions using of a benefit recognition model with a two-step
approach: (i) a more-likely-than-not recognition criterion and (ii) a measurement attribute that
measures the position as the largest amount of tax benefit that is greater than 50% likely of
being ultimately realized upon ultimate settlement. If it is not more likely than not that the
benefit will be sustained on its technical merits, no benefit is recorded. We recognize accrued
interest related to unrecognized tax benefits as a portion of our income tax provision in the
consolidated statements of operations. See Note 6. |
(l) |
|
Stock-based Compensation We recognize compensation expense for all share-based awards made
to employees, based upon the fair value of the share-based award on the date of the grant. We
measure and recognize compensation expense 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. See Note 7(b). |
(m) |
|
Comprehensive Income (Loss) Comprehensive income (loss) represents the net change in
shareholders equity during a period from sources other than transactions with shareholders.
Our comprehensive income or loss is comprised of net earnings, foreign currency translation,
changes in the fair value of forward exchange contracts accounted for as cash flow hedges, and
changes in the fair value of available-for-sale (AFS) fixed income securities. Components of
beginning and ending accumulated other comprehensive income or loss, and related activity, are
shown in the following table: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Currency |
|
|
|
|
|
|
Unrealized |
|
|
|
|
|
|
|
|
|
Translation |
|
|
Cash Flow |
|
|
Loss on AFS |
|
|
Income |
|
|
|
|
|
|
Adjustment |
|
|
Hedges |
|
|
Securities |
|
|
Taxes |
|
|
Total |
|
Balance at September 30, 2008 |
|
$ |
831 |
|
|
$ |
3 |
|
|
$ |
(270 |
) |
|
$ |
(198 |
) |
|
$ |
366 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Currency translation |
|
|
279 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
279 |
|
Reclassifications to earnings of hedging activity |
|
|
|
|
|
|
(112 |
) |
|
|
|
|
|
|
|
|
|
|
(112 |
) |
Net unrealized gains on hedging instruments |
|
|
|
|
|
|
109 |
|
|
|
|
|
|
|
|
|
|
|
109 |
|
Transfer of investments from available-for-sale
to trading classification |
|
|
|
|
|
|
|
|
|
|
270 |
|
|
|
|
|
|
|
270 |
|
Income taxes |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(190 |
) |
|
|
(190 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at September 30, 2009 |
|
$ |
1,110 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
(388 |
) |
|
$ |
722 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
- 57 -
|
|
Income taxes are allocable to components of accumulated other comprehensive income for fiscal 2009 and fiscal 2008
as shown in the following table: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign |
|
|
|
|
|
|
|
|
|
|
|
|
|
Currency |
|
|
|
|
|
|
Unrealized |
|
|
|
|
|
|
Translation |
|
|
Cash Flow |
|
|
Loss on AFS |
|
|
Income |
|
|
|
Adjustment |
|
|
Hedges |
|
|
Securities |
|
|
Taxes |
|
Balance at September 30, 2008 |
|
$ |
(292 |
) |
|
$ |
(1 |
) |
|
$ |
95 |
|
|
$ |
(198 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Fiscal 2009 activity |
|
|
(96 |
) |
|
|
1 |
|
|
|
(95 |
) |
|
|
(190 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at September 30, 2009 |
|
$ |
(388 |
) |
|
$ |
|
|
|
$ |
|
|
|
$ |
(388 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
(n) |
|
Supplemental Cash flow Information Supplemental cash flow information is as follows for
fiscal 2009, 2008 and 2007: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended September 30, |
|
2009 |
|
|
2008 |
|
|
2007 |
|
Cash paid for |
|
|
|
|
|
|
|
|
|
|
|
|
Income taxes |
|
$ |
17,472 |
|
|
$ |
15,365 |
|
|
$ |
12,412 |
|
Interest |
|
|
|
|
|
|
|
|
|
|
37 |
|
Non-cash items
|
|
|
|
|
|
|
|
|
|
|
|
|
Debenture conversions |
|
|
|
|
|
|
|
|
|
|
1,775 |
|
(o) |
|
Recent Accounting Pronouncements Effective October 1, 2008, we adopted the FASBs 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. See Note 5. |
|
|
In October 2008, the FASB issued clarifying guidance related to financial assets when the market
is inactive, such as the case with debt securities that were issued via the auction-rate
markets. This guidance was effective upon issuance and was taken into consideration in the
valuation of our investments in student loan auction-rate securities and the UBS Auction Rate
Security Rights. |
|
|
In connection with the UBS settlement discussed in Note 1(e), we adopted the fair value option
which 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 at each subsequent reporting
date. |
|
|
In April 2009, the FASB amended the other-than-temporary impairment guidance in US GAAP for debt
securities to make the guidance more operational and to improve the presentation and disclosure
of other-than temporary impairments on debt and equity securities in the financial statements.
As discussed above, we have elected the fair value option for our auction-rate securities.
Thus, this amendment had no effect on our statements of operations or financial position. |
- 58 -
|
|
In April 2009, the FASB amended its standards to require disclosures about fair value of
financial instruments for interim reporting periods of publicly traded companies, as well as in
annual financial statements. We have provided the additional disclosures required. |
|
|
In May 2009, the FASB amended its standards to establish general standards of accounting for and
disclosure of events that occur after the balance sheet date but before financial statements are
issued or are available to be issued. This amendment defines the period after the balance sheet
date during which management of a reporting entity should evaluate events or transactions that
may occur for potential recognition or disclosure in the financial statements, and the
circumstances under which an entity should recognize events or transactions occurring after the
balance sheet date in our financial statements. This amendment is effective for fiscal years
and interim periods ending after June 15, 2009. We adopted this standard as of June 30, 2009,
with the only impact being the provision of additional disclosures in this 10-K. Further, in
connection with preparation of the consolidated financial statements, we evaluated subsequent
events after the balance sheet date of September 30, 2009 through November 25, 2009, the last
business day before the date our consolidated financial statements included in this Annual
Report on Form 10-K, were filed with the SEC. |
|
|
In June 2009, the FASB amended its standards to establish the Accounting Standards Codification
(the Codification) as the source of generally accepted accounting principles (GAAP) recognized
by the FASB to be applied by nongovernmental entities. Following this amendment, the FASB will
not issue new standards in the form of Statements, FASB Staff Positions, or Emerging Issues Task
Force Abstracts. Instead, it will issue Accounting Standards Updates. Once in effect, all
guidance contained in the Codification carries an equal level of authority. The GAAP hierarchy
will be modified to include only two levels of GAAP: authoritative and non-authoritative. All
non-grandfathered, non-SEC accounting literature not included in the Codification will become
non-authoritative. This amendment is effective for interim or annual periods ending after
September 15, 2009. We adopted this standard as of June 30, 2009, with the only impact being
the removal of certain references in our financial statements to technical accounting
literature. |
(p) |
|
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. |
(q) |
|
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. |
- 59 -
(2) Inventories
Inventories are comprised of the following:
|
|
|
|
|
|
|
|
|
As of September 30, |
|
2009 |
|
|
2008 |
|
Raw materials |
|
$ |
6,079 |
|
|
$ |
5,354 |
|
Work-in-process |
|
|
5,916 |
|
|
|
5,723 |
|
Finished goods |
|
|
12,314 |
|
|
|
9,971 |
|
|
|
|
|
|
|
|
Gross Inventory |
|
$ |
24,309 |
|
|
$ |
21,048 |
|
|
|
|
|
|
|
|
Reserves |
|
|
(1,025 |
) |
|
|
(1,103 |
) |
|
|
|
|
|
|
|
Net Inventory |
|
$ |
23,284 |
|
|
$ |
19,945 |
|
|
|
|
|
|
|
|
(3) Bank Credit Arrangements
We have a $30,000 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, 2009
or September 30, 2008. Available borrowings under this credit facility were $30,000 at September
30, 2009 and September 30, 2008. In connection with this bank credit arrangement, we are required
to comply with financial covenants that limit the amount of debt obligations, 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, pursuant to this bank credit arrangement.
(4) Hedging Transactions
Prior to February 1, 2009, we managed exchange rate risk related to forecasted intercompany sales
denominated in the Euro currency through the use of forward exchange contracts and designated such
forward contracts as cash flow hedges. As such, the effective portion of the gain or loss on the
derivative instrument was reported as a component of other comprehensive income and reclassified
into revenues in the Consolidated Statement of Operations in the same period or periods during
which the hedged transaction affected earnings. As of September 30, 2009, we had no such contracts
outstanding.
During January 2009, 500 notional amount of forward exchange contracts were settled in
accordance with their original maturities. The realized gain on these contracts was $32. Also
during January 2009, we accelerated the settlement of the remaining 2,700 notional amount of
forward exchange contracts that were originally scheduled to mature between February 27, 2009 and
December 31, 2009. These transactions resulted in a gain of approximately $140 that was recorded
in the second quarter of fiscal 2009. We unwound these forward exchange contracts after completing
a strategic review of our foreign currency exposures. This strategic review revealed that we have
natural currency hedges in place for consolidated gross profit and operating income via certain
Meridian-branded diagnostic test kits that we purchase in Euros from suppliers in Spain and
Germany.
- 60 -
At September 30, 2008, $3 of unrealized gains were included in accumulated other comprehensive
income in the consolidated balance sheet. The estimated fair value of forward contracts
outstanding at September 30, 2008 was based on quoted amounts provided by the counterparties to
these contracts.
The fair value of our hedging portfolio, comprised solely of foreign exchange contracts, was an
asset of $27 at September 30, 2008. The amount of gain (loss) recognized in other comprehensive
income on the effective portion of these foreign exchange contracts was $109, $(326), and $(377) in
fiscal 2009, 2008, and 2007, respectively. The amount of gain (loss) reclassified from accumulated
other comprehensive income into income on the effective portion of these foreign exchange contracts
was $112, $(599), and $(94), for fiscal 2009, 2008, and 2007, respectively. No portion of the
gain/loss was excluded from other comprehensive income due to effectiveness testing.
(5) Fair Value Measurements
We adopted the fair value measurement as prescribed by the FASB on October 1, 2008 to value our
financial assets and liabilities. Fair value is the price that would be received to sell an asset
or paid to transfer a liability in an orderly transaction between market participants at the
measurement date. Fair value hierarchy prioritizes inputs to valuation techniques used to measure
fair value into three broad levels, which are described below:
Level 1: Quoted prices (unadjusted) in active markets for identical assets or liabilities that are
accessible at the measurement date for assets and liabilities. The fair value hierarchy gives the
highest priority to Level 1 inputs.
Level 2: Inputs other than quoted prices included within Level 1 that are observable for the assets
or liabilities, either directly or indirectly. These include quoted prices for
identical or similar assets or liabilities in markets that are not active, that is, markets in
which there are few transactions for the asset or liability, the prices are not current, or price
quotations vary substantially either over time or among market makers, or in which little
information is released publicly and inputs that are derived principally from or corroborated by
observable market data by correlation or other means.
Level 3: Unobservable inputs, developed using the Companys estimates and assumptions, which
reflect those that the market participants would use. Such inputs are used when little or no
market data is available. The fair value hierarchy gives the lowest priority to Level 3 inputs.
Determining where an asset or liability falls within the hierarchy depends on the lowest level
input that is significant to the fair value measurement as a whole. In determining fair value, the
Company utilizes valuation techniques that maximize the use of observable inputs and minimize the
use of unobservable inputs to the extent possible and considers counterparty credit risk in the
assessment of fair value.
- 61 -
Financial assets and liabilities carried at fair value at September 30, 2009 and September 30, 2008
are classified
in the table below in one of the three categories described above:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Level 1 |
|
|
Level 2 |
|
|
Level 3 |
|
|
Total |
|
Balances as of September 30, 2009 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and equivalents |
|
$ |
54,030 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
54,030 |
|
Student loan auction-rate securities |
|
|
|
|
|
|
|
|
|
|
6,708 |
|
|
|
6,708 |
|
UBS Auction Rate Security Rights |
|
|
|
|
|
|
|
|
|
|
577 |
|
|
|
577 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
54,030 |
|
|
$ |
|
|
|
$ |
7,285 |
|
|
$ |
61,315 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Level 1 |
|
|
Level 2 |
|
|
Level 3 |
|
|
Total |
|
Balances as of September 30, 2008 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and equivalents |
|
$ |
49,297 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
49,297 |
|
Student loan auction-rate securities |
|
|
|
|
|
|
|
|
|
|
7,480 |
|
|
|
7,480 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
49,297 |
|
|
$ |
|
|
|
$ |
7,480 |
|
|
$ |
56,777 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The failed auction status and lack of liquidity for our student loan auction-rate securities and
the non-transferability of our UBS Auction Rate Security Rights requires the use of a valuation
methodology that relies exclusively on Level 3 inputs including market, tax status, credit quality,
duration, recent market observations and overall capital market liquidity. The valuation of our
student loan auction-rate securities and UBS Auction Rate Security Rights is subject to
uncertainties that are difficult to predict. Factors that may impact the valuations include
changes to credit ratings of the securities as well as to the underlying assets supporting those
securities, rates of default of the underlying assets, underlying collateral value, discount rates,
counterparty risk and ongoing strength and quality of market credit and liquidity. The following
table provides a summary of changes in fair value of our auction-rate securities and UBS Auction
Rate Security Rights for the fiscal years ended September 30, 2009 and September 30, 2008.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Student loan |
|
|
UBS Auction |
|
|
|
|
|
|
auction-rate |
|
|
Rate Security |
|
|
|
|
|
|
securities |
|
|
Rights |
|
|
Total Level 3 |
|
Balance at September 30, 2008 |
|
$ |
7,480 |
|
|
$ |
|
|
|
$ |
7,480 |
|
Acquire UBS Auction Rate Security Rights |
|
|
|
|
|
|
660 |
|
|
|
660 |
|
Proceeds from redemptions of
auction-rate securities |
|
|
(475 |
) |
|
|
|
|
|
|
(475 |
) |
Unrealized losses included in current
period earnings |
|
|
(297 |
) |
|
|
(83 |
) |
|
|
(380 |
) |
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
6,708 |
|
|
$ |
577 |
|
|
$ |
7,285 |
|
|
|
|
|
|
|
|
|
|
|
- 62 -
(6) Income Taxes
|
|
|
(a) |
|
Earnings before income taxes, and the related provision for income taxes for the years ended
September 30, 2009, 2008 and 2007 were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended September 30, |
|
2009 |
|
|
2008 |
|
|
2007 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Domestic |
|
$ |
46,504 |
|
|
$ |
42,187 |
|
|
$ |
33,324 |
|
Foreign |
|
|
2,819 |
|
|
|
3,805 |
|
|
|
3,358 |
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
49,323 |
|
|
$ |
45,992 |
|
|
$ |
36,682 |
|
|
|
|
|
|
|
|
|
|
|
Provision (credit) for income taxes |
|
|
|
|
|
|
|
|
|
|
|
|
Federal |
|
|
|
|
|
|
|
|
|
|
|
|
Current provision |
|
$ |
15,094 |
|
|
$ |
14,307 |
|
|
$ |
11,179 |
|
Temporary differences |
|
|
|
|
|
|
|
|
|
|
|
|
Fixed asset basis differences and depreciation |
|
|
16 |
|
|
|
(108 |
) |
|
|
(105 |
) |
Intangible asset basis differences and amortization |
|
|
(363 |
) |
|
|
(249 |
) |
|
|
(249 |
) |
Currently non-deductible expenses and reserves |
|
|
(134 |
) |
|
|
(286 |
) |
|
|
238 |
|
Stock based compensation |
|
|
(373 |
) |
|
|
(610 |
) |
|
|
(678 |
) |
Other, net |
|
|
48 |
|
|
|
231 |
|
|
|
(258 |
) |
Tax contingency reserve adjustment |
|
|
|
|
|
|
|
|
|
|
(2,425 |
) |
|
|
|
|
|
|
|
|
|
|
Subtotal |
|
|
14,288 |
|
|
|
13,285 |
|
|
|
7,702 |
|
State and local |
|
|
1,385 |
|
|
|
1,303 |
|
|
|
1,250 |
|
Foreign |
|
|
891 |
|
|
|
1,202 |
|
|
|
1,009 |
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
16,564 |
|
|
$ |
15,790 |
|
|
$ |
9,961 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(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: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended September 30, |
|
2009 |
|
|
2008 |
|
|
2007 |
|
Computed income taxes at statutory rate |
|
$ |
17,263 |
|
|
|
35.0 |
% |
|
$ |
16,097 |
|
|
|
35.0 |
% |
|
$ |
12,839 |
|
|
|
35.0 |
% |
Increase (decrease) in taxes resulting from |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
State and local income taxes |
|
|
904 |
|
|
|
1.8 |
|
|
|
902 |
|
|
|
2.0 |
|
|
|
835 |
|
|
|
2.3 |
|
Federal and state tax credits |
|
|
(189 |
) |
|
|
(0.4 |
) |
|
|
(34 |
) |
|
|
(0.1 |
) |
|
|
(213 |
) |
|
|
(0.6 |
) |
Foreign tax rate differences |
|
|
(43 |
) |
|
|
(0.1 |
) |
|
|
196 |
|
|
|
0.4 |
|
|
|
170 |
|
|
|
0.5 |
|
Valuation allowance reversal France |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(309 |
) |
|
|
(0.8 |
) |
Qualified domestic production
incentives |
|
|
(870 |
) |
|
|
(1.8 |
) |
|
|
(715 |
) |
|
|
(1.6 |
) |
|
|
(290 |
) |
|
|
(0.8 |
) |
Tax exempt interest |
|
|
(100 |
) |
|
|
(0.2 |
) |
|
|
(417 |
) |
|
|
(0.9 |
) |
|
|
(418 |
) |
|
|
(1.1 |
) |
Tax contingency reserve adjustment |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(2,425 |
) |
|
|
(6.6 |
) |
US book-to-return and uncertain tax
position activity |
|
|
(412 |
) |
|
|
(0.8 |
) |
|
|
(177 |
) |
|
|
(0.4 |
) |
|
|
(344 |
) |
|
|
(0.9 |
) |
Other, net |
|
|
11 |
|
|
|
0.1 |
|
|
|
(62 |
) |
|
|
(0.1 |
) |
|
|
116 |
|
|
|
0.2 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
16,564 |
|
|
|
33.6 |
% |
|
$ |
15,790 |
|
|
|
34.3 |
% |
|
$ |
9,961 |
|
|
|
27.2 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
- 63 -
|
|
|
(c) |
|
The components of net deferred tax assets (liabilities) were as follows: |
|
|
|
|
|
|
|
|
|
As of September 30, |
|
2009 |
|
|
2008 |
|
Deferred tax assets |
|
|
|
|
|
|
|
|
Valuation reserves and non-deductible expenses |
|
$ |
1,043 |
|
|
$ |
951 |
|
Stock compensation expense not deductible |
|
|
1,762 |
|
|
|
1,527 |
|
Net operating loss carryforwards |
|
|
948 |
|
|
|
865 |
|
Inventory basis differences |
|
|
886 |
|
|
|
779 |
|
Other |
|
|
6 |
|
|
|
6 |
|
|
|
|
|
|
|
|
Subtotal |
|
|
4,645 |
|
|
|
4,128 |
|
Less valuation allowance |
|
|
(470 |
) |
|
|
(466 |
) |
|
|
|
|
|
|
|
Deferred tax assets |
|
|
4,175 |
|
|
|
3,662 |
|
|
|
|
|
|
|
|
Deferred tax liabilities |
|
|
|
|
|
|
|
|
Fixed asset basis differences and depreciation |
|
|
(656 |
) |
|
|
(639 |
) |
Intangible asset basis differences and amortization |
|
|
(2,263 |
) |
|
|
(2,680 |
) |
Other |
|
|
(661 |
) |
|
|
(488 |
) |
|
|
|
|
|
|
|
Deferred tax liabilities |
|
|
(3,580 |
) |
|
|
(3,807 |
) |
|
|
|
|
|
|
|
Net deferred tax assets (liabilities) |
|
$ |
595 |
|
|
$ |
(145 |
) |
|
|
|
|
|
|
|
For income tax purposes, we have tax benefits related to operating loss carryforwards in the
countries of Belgium and France. These net operating loss carryforwards have no expiration date.
We have recorded deferred tax assets for these carryforwards, inclusive of valuation allowances for
the country of Belgium at September 30, 2009. This valuation allowance is 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, 2009 and September 30, 2008 related solely to net operating loss
carryforwards in Belgium.
The realization of deferred tax assets in foreign jurisdictions is dependent upon the generation of
future taxable income in certain European countries. We have 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, we believe that it is more likely than not that the net deferred tax asset for
foreign jurisdictions, after consideration of the valuation allowance, which has been established,
will be realized. The amount of the net deferred tax asset considered realizable in foreign
jurisdictions, however, could be reduced in future years if estimates of future taxable income
during the carryforward period are reduced.
Undistributed earnings re-invested indefinitely in the Italian operation were approximately $18,600
at September 30, 2009. US deferred tax liabilities of approximately $6,865 on such earnings have
not been recorded. We believe that such US taxes would be largely offset by foreign tax credits
for taxes paid in Italy.
- 64 -
Effective October 1, 2007, we adopted a comprehensive model for the recognition, measurement,
presentation and disclosure of uncertain tax positions, assuming full knowledge of all relevant
facts by the applicable tax
authorities. The cumulative effect of adoption, $305, was charged to opening retained earnings.
The total amount of unrecognized tax benefits at September 30, 2009 and September 30, 2008 was $572
and $779, respectively, of which the full amounts would favorably affect the effective tax rate if
recognized. We recognize interest and penalties related to uncertain tax positions as a component
of our income tax provision. During fiscal 2009, we credited approximately $45 in interest and
penalties to our tax provision. We had approximately $102 accrued for the payment of interest and
penalties at September 30, 2009 compared to $147 accrued at September 30, 2008. The amount of our
liability for uncertain tax positions expected to be paid or settled in the next 12 months is
uncertain.
A reconciliation of the beginning and ending amounts of unrecognized tax benefits is as follows:
|
|
|
|
|
|
|
|
|
|
|
2009 |
|
|
2008 |
|
Unrecognized income tax benefits beginning of year |
|
$ |
779 |
|
|
$ |
856 |
|
Additions for tax positions related to the current year |
|
|
115 |
|
|
|
123 |
|
Additions for tax positions of prior years |
|
|
109 |
|
|
|
125 |
|
Reductions for tax positions of prior years |
|
|
(287 |
) |
|
|
(13 |
) |
Settlements |
|
|
|
|
|
|
(20 |
) |
Expirations of statute of limitations |
|
|
(144 |
) |
|
|
(292 |
) |
|
|
|
|
|
|
|
Unrecognized income tax benefits at end of year |
|
$ |
572 |
|
|
$ |
779 |
|
|
|
|
|
|
|
|
We are subject to examination by the tax authorities in the US (both federal and state) and the
countries of Belgium, France, Holland and Italy. In the US, open tax years are for fiscal 2006 and
forward, although, we completed an examination by the IRS for fiscal 2006 in February 2008. In
countries outside the US, open tax years generally range from fiscal 2004 and forward. However, in
Belgium, the utilization of local net operating loss carryforwards extends the statute of
limitations for examination well into the foreseeable future. Tax examinations in France were
completed for fiscal years 2004-2006 during fiscal 2007.
In fiscal 2000, we recorded a tax benefit related to the insolvency of a foreign subsidiary that
has since been liquidated and dissolved. At that time, a reserve was also provided for future
resolution of uncertainties related to this matter. During June 2007, the statute of limitations
expired on the tax returns affected by this matter, and consequently, the adjustment to tax
reserves resulted in a tax benefit of $2,425.
(7) Employee Benefits
(a) |
|
Savings and Investment Plan We have a profit sharing and retirement savings plan covering
substantially all full-time US employees. Profit sharing contributions to the plan, which are
discretionary, are approved by the Board of Directors. The plan permits participants to
contribute to the plan through salary reduction. Under terms of the plan, we match 50% of an
employees contributions, up to maximum match of 3% of eligible compensation. Our
discretionary and matching contributions to the plan amounted to approximately $1,188, $1,214,
and $1,132, during fiscal 2009, 2008 and 2007, respectively. |
- 65 -
(b) |
|
Stock-Based Compensation Plans We have one active stock-based compensation plan, the 2004
Equity Compensation plan, which became effective December 7, 2004, as amended (the 2004
Plan) and an Employee Stock Purchase Plan (the ESP Plan), which became effective October 1,
1997. Effective October 1, 1997, we began selling shares of stock to our full-time and
part-time employees under the ESP Plan up to the number of shares equivalent to a 1% to 15%
payroll deduction from an employees base salary plus an additional 5% dollar match of this
deduction by Meridian. |
|
|
|
We may grant new shares for options or restricted shares for up to 3,000 shares under the 2004
Plan, of which we have granted 1,483 through September 30, 2009. 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 shares under similar
plans that have expired. |
|
|
|
On November 14, 2007, we granted 252 options to certain employees subject to attainment of a
specified earnings target for fiscal 2008. As the target was not met and the options forfeited,
they have been excluded from the tables below. On November 12, 2008, we granted approximately
94 restricted shares to certain employees subject to attainment of a specified earnings target
for fiscal 2009. Dividends were paid on these restricted shares throughout fiscal 2009. The
target was not met and these restricted shares have been forfeited. |
|
|
|
We recognize compensation expense for all share-based payments made to employees, based upon the
fair value of the share-based payment on the date of the grant. We measure and recognize
compensation expense based on grant-date fair value for stock option awards granted after July
1, 2005 and the non-vested portions of stock option awards granted prior to July 1, 2005. |
|
|
|
The amount of stock-based compensation expense reported was $1,092, $1,772, and $2,632 in fiscal
2009, fiscal 2008, and fiscal 2007, respectively. The total income tax benefit recognized in
the income statement for these stock-based compensation arrangements was $367, $610, and $678,
for fiscal 2009, fiscal 2008, and fiscal 2007, respectively. We expect future stock
compensation expense for unvested options as of September 30, 2009 to be $937, which will be
recognized during fiscal years 2010 through 2013. |
|
|
|
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 2009, fiscal 2008, and
fiscal 2007, we recorded $42, $235 and $210, respectively, in stock compensation expense to
adjust estimated forfeiture rates to actual. |
- 66 -
|
|
We have elected to use the Black-Scholes option pricing model to determine grant-date fair
value, with the following assumptions: (i) expected share price volatility based on implied
volatility calculations using options for Meridian and a peer-group of companies; (ii) expected
life of options based on contractual lives, employees historical exercise behavior and
employees historical post-vesting employment termination behavior; (iii) risk-free interest
rates based on treasury rates that correspond to the expected lives of the options; and (iv)
dividend yield based on the expected yield on underlying Meridian common stock. |
|
|
|
|
|
|
|
|
|
|
|
|
|
Year ended September 30, |
|
2009 |
|
|
2008 |
|
|
2007 |
|
Risk-free interest rates |
|
|
3.75 |
% |
|
|
4.56 |
% |
|
|
4.64 |
% |
Dividend yield |
|
|
2.41 |
% |
|
|
1.45 |
% |
|
|
1.96 |
% |
Life of option |
|
|
6.30-8.20 yrs. |
|
|
|
5.70-7.30 yrs. |
|
|
|
5.80-7.50 yrs. |
|
Share price volatility |
|
|
57 |
% |
|
|
44 |
% |
|
|
44 |
% |
Forfeitures (by
employee group) |
|
|
0%-13 |
% |
|
|
0%-17 |
% |
|
|
0%-20 |
% |
|
|
A summary of the status of our stock option plans at September 30, 2009 and changes during the
year is presented in the table and narrative below: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Wtd Avg |
|
|
Wtd Avg |
|
|
Aggregate |
|
|
|
|
|
|
|
Exercise |
|
|
Remaining |
|
|
Intrinsic |
|
|
|
Shares |
|
|
Price |
|
|
Life (Yrs) |
|
|
Value |
|
Outstanding beginning of period |
|
|
1,548 |
|
|
$ |
9.95 |
|
|
|
|
|
|
|
|
|
Grants |
|
|
62 |
|
|
|
22.68 |
|
|
|
|
|
|
|
|
|
Exercises |
|
|
(180 |
) |
|
|
6.97 |
|
|
|
|
|
|
|
|
|
Forfeitures |
|
|
(22 |
) |
|
|
20.27 |
|
|
|
|
|
|
|
|
|
Cancellations |
|
|
(7 |
) |
|
|
18.46 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding end of period |
|
|
1,401 |
|
|
$ |
10.69 |
|
|
|
4.9188 |
|
|
$ |
20,896 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercisable end of period |
|
|
648 |
|
|
$ |
11.17 |
|
|
|
5.2482 |
|
|
$ |
9,283 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
- 67 -
|
|
A summary of the status of our nonvested shares as of September 30, 2009, and changes during
the year ended September 30, 2009, is presented below: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted- |
|
|
|
|
|
|
|
Average |
|
|
|
|
|
|
|
Grant Date |
|
|
|
Shares |
|
|
Fair Value |
|
Nonvested beginning of period |
|
|
1,019 |
|
|
$ |
4.79 |
|
Granted |
|
|
62 |
|
|
|
11.05 |
|
Vested |
|
|
(306 |
) |
|
|
6.54 |
|
Forfeited |
|
|
(22 |
) |
|
|
8.74 |
|
|
|
|
|
|
|
|
Nonvested end of period |
|
|
753 |
|
|
$ |
4.44 |
|
|
|
|
|
|
|
|
|
|
The weighted average grant-date fair value of options granted was $22.68, $14.58, and $7.10 for
fiscal 2009, 2008, and 2007, respectively. The total intrinsic value of options exercised was
$2,560, $11,405 and $5,526, for fiscal 2009, 2008, and 2007, respectively. The total grant-date
fair value of options that vested during fiscal 2009, 2008, and 2007 was $2,019, $1,674 and
$721, respectively. |
|
|
|
Cash received from options exercised was $1,243, $2,668, and $1,318 for fiscal 2009, 2008, and
2007, respectively. Tax benefits realized and recorded to additional paid-in capital from
option exercises totaled $233, $2,458, and $1,632 for fiscal 2009, 2008, and 2007 respectively. |
(8) 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.
- 68 -
Sales to individual customers constituting 10% or more of consolidated net sales were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended September 30, |
|
2009 |
|
|
2008 |
|
|
2007 |
|
Customer A |
|
$ |
37,876 |
|
|
|
(26 |
)% |
|
$ |
31,285 |
|
|
|
(22 |
)% |
|
$ |
24,444 |
|
|
|
(20 |
)% |
Customer B |
|
$ |
19,063 |
|
|
|
(13 |
)% |
|
$ |
16,160 |
|
|
|
(12 |
)% |
|
$ |
13,340 |
|
|
|
(11 |
)% |
Combined export sales for the US Diagnostics and Life Science operating segments were $15,568,
$16,450 and $15,128 in fiscal years 2009, 2008 and 2007, respectively. Three products accounted
for 30%, 32%, and 31% of consolidated net sales in fiscal 2009, fiscal 2008, and fiscal 2007,
respectively. Approximately 25% of the consolidated accounts receivable balance at September 30,
2009 is largely dependent upon funds from the Italian government.
Significant sales information by country for the European Diagnostics operating segment is as
follows. Sales are attributed to the geographic area based on the location to which the product is
shipped.
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended September 30, |
|
2009 |
|
|
2008 |
|
|
2007 |
|
Italy |
|
$ |
8,289 |
|
|
$ |
8,942 |
|
|
$ |
7,838 |
|
France |
|
|
2,939 |
|
|
|
3,263 |
|
|
|
3,070 |
|
United Kingdom |
|
|
2,373 |
|
|
|
2,655 |
|
|
|
1,987 |
|
Belgium |
|
|
1,875 |
|
|
|
1,865 |
|
|
|
1,558 |
|
Holland |
|
|
1,828 |
|
|
|
2,138 |
|
|
|
1,610 |
|
Other countries |
|
|
8,566 |
|
|
|
9,117 |
|
|
|
7,500 |
|
|
|
|
|
|
|
|
|
|
|
Total European Operating Segment |
|
$ |
25,870 |
|
|
$ |
27,980 |
|
|
$ |
23,563 |
|
|
|
|
|
|
|
|
|
|
|
Identifiable assets for our Italian distribution organization were $16,797, $14,769, and $12,811 at
September 30, 2009, 2008 and 2007, respectively.
- 69 -
Segment information for the years ended September 30, 2009, 2008 and 2007 is as follows (dollars in
thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
US |
|
|
European |
|
|
|
|
|
|
|
|
|
|
|
|
Diagnostics |
|
|
Diagnostics |
|
|
Life Science |
|
|
Elim (1) |
|
|
Total |
|
Fiscal Year 2009 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net sales |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Third-party |
|
$ |
98,970 |
|
|
$ |
25,870 |
|
|
$ |
23,434 |
|
|
$ |
|
|
|
$ |
148,274 |
|
Inter-segment |
|
|
10,700 |
|
|
|
6 |
|
|
|
715 |
|
|
|
(11,421 |
) |
|
|
|
|
Operating income |
|
|
39,490 |
|
|
|
4,459 |
|
|
|
4,728 |
|
|
|
102 |
|
|
|
48,779 |
|
Depreciation and amortization |
|
|
2,680 |
|
|
|
92 |
|
|
|
1,588 |
|
|
|
|
|
|
|
4,360 |
|
Capital expenditures |
|
|
2,082 |
|
|
|
81 |
|
|
|
1,480 |
|
|
|
|
|
|
|
3,643 |
|
Total assets |
|
|
131,586 |
|
|
|
18,221 |
|
|
|
55,592 |
|
|
|
(49,402 |
) |
|
|
155,997 |
|
|
Fiscal Year 2008 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net sales |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Third-party |
|
$ |
88,419 |
|
|
$ |
27,980 |
|
|
$ |
23,240 |
|
|
$ |
- |
|
|
$ |
139,639 |
|
Inter-segment |
|
|
11,563 |
|
|
|
2 |
|
|
|
543 |
|
|
|
(12,108 |
) |
|
|
|
|
Operating income |
|
|
36,095 |
|
|
|
5,397 |
|
|
|
3,186 |
|
|
|
(328 |
) |
|
|
44,350 |
|
Depreciation and amortization |
|
|
2,745 |
|
|
|
111 |
|
|
|
1,614 |
|
|
|
|
|
|
|
4,470 |
|
Capital expenditures |
|
|
2,193 |
|
|
|
39 |
|
|
|
1,987 |
|
|
|
|
|
|
|
4,219 |
|
Total assets |
|
|
126,808 |
|
|
|
15,955 |
|
|
|
49,619 |
|
|
|
(45,951 |
) |
|
|
146,431 |
|
|
Fiscal Year 2007 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net sales |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Third-party |
|
$ |
74,845 |
|
|
$ |
23,563 |
|
|
$ |
24,555 |
|
|
$ |
|
|
|
$ |
122,963 |
|
Inter-segment |
|
|
8,872 |
|
|
|
|
|
|
|
532 |
|
|
|
(9,404 |
) |
|
|
|
|
Operating income |
|
|
26,454 |
|
|
|
4,930 |
|
|
|
3,795 |
|
|
|
(149 |
) |
|
|
35,030 |
|
Depreciation and amortization |
|
|
2,641 |
|
|
|
110 |
|
|
|
1,648 |
|
|
|
|
|
|
|
4,399 |
|
Capital expenditures |
|
|
1,645 |
|
|
|
52 |
|
|
|
1,514 |
|
|
|
|
|
|
|
3,211 |
|
Total assets |
|
|
115,297 |
|
|
|
13,600 |
|
|
|
45,410 |
|
|
|
(41,609 |
) |
|
|
132,698 |
|
|
|
|
(1) |
|
Eliminations consist of intersegment transactions. |
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended September 30, |
|
2009 |
|
|
2008 |
|
|
2007 |
|
Segment operating income |
|
$ |
48,779 |
|
|
$ |
44,350 |
|
|
$ |
35,030 |
|
Interest income |
|
|
456 |
|
|
|
1,533 |
|
|
|
1,642 |
|
Interest expense |
|
|
|
|
|
|
|
|
|
|
(38 |
) |
Other, net |
|
|
88 |
|
|
|
109 |
|
|
|
48 |
|
|
|
|
|
|
|
|
|
|
|
Consolidated earnings before
income taxes |
|
$ |
49,323 |
|
|
$ |
45,992 |
|
|
$ |
36,682 |
|
|
|
|
|
|
|
|
|
|
|
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 $1,381 and $8,485, respectively at September 30, 2009,
$1,382 and $8,479, respectively at September 30, 2008, and $1,491 and $8,472, respectively at
September 30, 2007.
- 70 -
(9) 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 $572, $600, and $739, respectively, for the fiscal years ended September 30,
2009, 2008 and 2007. |
|
|
|
Meridian entered into a license agreement in October 2006 with a third party that provides
rights to a molecular technology for infectious disease testing in the United States, Europe,
and other geographic markets. The agreement, as amended during fiscal 2009, calls for payments
of up to approximately $800 based on the achievement of certain milestones and on-going
royalties once products are available for commercial sale. Payments made during product
development are expected to occur over a five-year period, which began in fiscal 2007.
Payments of $104, $0 and $169 were made during fiscal 2009, fiscal 2008 and fiscal 2007,
respectively, related to this license. |
|
|
|
During the fourth quarter of fiscal 2007, we began seeking recovery of approximately $1,400 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. |
|
(b) |
|
Purchase Commitments We have purchase commitments primarily for inventory and service items
as part of the normal course of business. Commitments made under these obligations are
$12,917, $624, and $147 for fiscal 2010, 2011, and 2012, respectively. No commitments have
been made beyond fiscal 2012. |
|
(c) |
|
Operating Lease Commitments Meridian and its subsidiaries are lessees of (i) office and
warehouse buildings in Cincinnati, 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 $775, $674 and $696 for fiscal 2009, 2008 and 2007, respectively. Operating lease
commitments for each of the five succeeding fiscal years are as follows: fiscal 2010 $610,
fiscal 2011 $384, fiscal 2012 $225, fiscal 2013 $140, and fiscal 2014 $130. |
|
(d) |
|
Litigation We are a party to various litigation matters from time to time that we believe
are in the normal course of business. The ultimate resolution of these 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. |
- 71 -
(e) |
|
Indemnifications In conjunction with certain contracts and agreements, we provide routine
indemnifications whose terms range in duration and in some circumstances are not explicitly
defined. The maximum obligation under some such indemnifications is not explicitly stated
and, as a result, cannot be reasonably estimated. We have not made any payments for these
indemnifications and no liability is recorded at September 30, 2009 or September 30, 2008. 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. |
(10) Quarterly Financial Data (Unaudited)
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 2009 |
|
December 31 |
|
|
March 31 |
|
|
June 30 |
|
|
September 30 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net sales |
|
$ |
34,293 |
|
|
$ |
33,280 |
|
|
$ |
38,240 |
|
|
$ |
42,461 |
|
Gross profit |
|
|
23,344 |
|
|
|
20,974 |
|
|
|
23,323 |
|
|
|
25,142 |
|
Net earnings |
|
|
8,076 |
|
|
|
7,251 |
|
|
|
8,502 |
|
|
|
8,930 |
|
Basic earnings per common share |
|
|
0.20 |
|
|
|
0.18 |
|
|
|
0.21 |
|
|
|
0.22 |
|
Diluted earnings per common share |
|
|
0.20 |
|
|
|
0.18 |
|
|
|
0.21 |
|
|
|
0.22 |
|
Cash dividends per common share |
|
|
0.14 |
|
|
|
0.17 |
|
|
|
0.17 |
|
|
|
0.17 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Quarter Ended in Fiscal 2008 |
|
December 31 |
|
|
March 31 |
|
|
June 30 |
|
|
September 30 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net sales |
|
$ |
33,847 |
|
|
$ |
36,249 |
|
|
$ |
33,068 |
|
|
$ |
36,475 |
|
Gross profit |
|
|
21,752 |
|
|
|
21,115 |
|
|
|
21,287 |
|
|
|
22,326 |
|
Net earnings |
|
|
7,456 |
|
|
|
7,299 |
|
|
|
7,763 |
|
|
|
7,684 |
|
Basic earnings per common share |
|
|
0.19 |
|
|
|
0.18 |
|
|
|
0.19 |
|
|
|
0.19 |
|
Diluted earnings per common share |
|
|
0.18 |
|
|
|
0.18 |
|
|
|
0.19 |
|
|
|
0.19 |
|
Cash dividends per common share |
|
|
0.11 |
|
|
|
0.14 |
|
|
|
0.14 |
|
|
|
0.14 |
|
(11) Stock Split
On April 19, 2007, we announced a three-for-two stock split, with fractional shares paid in
cash. This split was effective on May 11, 2007, for shareholders of record on May 4, 2007. All
references in this Annual Report on Form 10-K to number of shares and per share amounts reflect
this stock split.
ITEM 9.
CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS
ON ACCOUNTING AND FINANCIAL DISCLOSURE
Not applicable.
- 72 -
ITEM 9A.
CONTROLS AND PROCEDURES
As of September 30, 2009, 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, 2009. 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, 2009.
Our internal control report is included in this Annual Report on Form 10-K after Item 8, under the
caption Managements Report on Internal Control over Financial Reporting.
ITEM 9B.
OTHER INFORMATION
Not applicable.
- 73 -
PART III
The information required by Items 10., 11., 13., and 14., of Part III are incorporated by reference
from the Registrants Proxy Statement for its 2010 Annual Shareholders Meeting to be filed with
the Commission pursuant to Regulation 14A.
ITEM 12.
EQUITY COMPENSATION PLAN INFORMATION
The following table presents summary information as of September 30, 2009 with respect to all of
our equity compensation plans.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(c) |
|
|
|
(a) |
|
|
(b) |
|
|
Number of |
|
|
|
Number of |
|
|
Weighted- |
|
|
securities remaining |
|
|
|
Securities to be |
|
|
average exercise |
|
|
available for future |
|
|
|
issued upon |
|
|
price of |
|
|
issuance under |
|
|
|
exercise of |
|
|
outstanding |
|
|
equity compensation |
|
|
|
outstanding |
|
|
options, |
|
|
plans (excluding |
|
|
|
options, warrants |
|
|
warrants and |
|
|
securities reflected |
|
Plan Category |
|
and rights |
|
|
rights |
|
|
in column (a)) |
|
Equity compensation plans
approved by security
holders(1) |
|
|
1,382 |
|
|
$ |
10.715 |
|
|
|
1,868 |
|
Equity compensation plans
not approved by security
holders |
|
|
19 |
|
|
|
8.893 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
1,401 |
|
|
$ |
10.691 |
|
|
|
1,868 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
1994 Directors Stock Option Plan
1996 Stock Option Plan, as amended in 2001
1999 Directors Stock Option Plan
2004 Equity Compensation Plan, as amended |
- 74 -
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.
|
|
|
Exhibit Number |
|
Description of Exhibit |
|
|
|
3.1
|
|
Articles of Incorporation, including amendments not related to Company name change
(Incorporated by reference to Registration Statement No. 333-02613 on Form S-3 filed
with the Securities and Exchange Commission on April 18, 1996 and Meridians Form 8-K
filed with the Securities and Exchange Commission on May 16, 2007) |
|
|
|
3.2
|
|
Code of Regulations (Incorporated by reference to Meridians Form 8-K filed with the
Securities and Exchange Commission on July 23, 2008) |
|
|
|
10.5
|
|
Sublicense Agreement dated June 17, 1993 among Johnson & Johnson, the Scripps Research
Institute and Meridian Concerning certain Patent Rights (Incorporated by reference to
Meridians Form 8-K filed with the Securities and Exchange Commission on June 17, 1993) |
|
|
|
10.6
|
|
Assignment dated June 17, 1993 from Ortho Diagnostic Systems Inc. to Meridian
concerning certain Patent Rights (Incorporated by reference to Meridians Form 8-K
filed with the Securities and Exchange Commission on June 17, 1993) |
|
|
|
10.9
|
|
Merger Agreement among Gull Laboratories, Inc., Meridian Diagnostics, Inc. Fresenius AG
and Meridian Acquisition Co. dated as of September 15, 1998 (Incorporated by reference
to Meridians Form 8-K filed with the Securities and Exchange Commission on September
17, 1998) |
|
|
|
10.10*
|
|
Savings and Investment Plan Prototype Adoption Agreement (Incorporated by reference to
Meridians Annual Report on Form 10-K for the Fiscal Year Ended September 30, 2003) |
|
|
|
10.14*
|
|
1994 Directors Stock Option Plan (Incorporated by reference to Registration Statement
No. 33-78868 on Form S-8 filed with the Securities and Exchange Commission on May 12,
1994) |
|
|
|
10.15*
|
|
1996 Stock Option Plan (Incorporated by reference to Meridians Annual Report on Form
10-K for the Fiscal Year Ended September 30, 1996) |
|
|
|
10.16*
|
|
Salary Continuation Agreement between Meridian Bioscience, Inc. and John A. Kraeutler,
as amended April 24, 2001 and December 29, 2008 (filed herewith) |
|
|
|
10.17
|
|
Merger Agreement Among Gull Laboratories, Inc., Meridian Diagnostics, Inc. Fresenius AG
and Meridian Acquisition Co. dated as of September 15, 1998, as amended on October 22,
1998 (Incorporated by reference to Meridians Report on Form 8-K filed with the
Securities and Exchange Commission on September 17, 1998 and Meridians Report on Form
8-K filed with the Securities and Exchange Commission on November 13, 1998) |
|
|
|
10.18*
|
|
1999 Directors Stock Option Plan (Incorporated by reference to Meridians Proxy
Statement filed with the Securities and Exchange Commission on December 21, 1998) |
- 75 -
|
|
|
Exhibit Number |
|
Description of Exhibit |
|
|
|
10.20
|
|
Dividend Reinvestment Plan (Incorporated by reference to Meridians Annual Report on
Form 10-K for the Fiscal Year Ended September 30, 1999) |
|
|
|
10.21
|
|
Merger Agreement dated September 13, 2000 among Meridian and the Shareholders of Viral
Antigens, Inc. (Incorporated by reference to Meridians Form 8-K filed with the
Securities and Exchange Commission on September 29, 2000) |
|
|
|
10.23*
|
|
Employment Agreement Dated February 15, 2001, as amended December 29, 2008 between
Meridian and John A. Kraeutler (filed herewith) |
|
|
|
10.24*
|
|
Sample Option Agreement Dated October 1, 2001 (Incorporated by reference to Meridians
Annual Report on Form 10-K for the Fiscal Year Ended September 30, 2001) |
|
|
|
10.26*
|
|
1996 Stock Option Plan as Amended and Restated Effective January 23, 2001 (Incorporated
by reference to Meridians Proxy Statement filed with the Securities and Exchange
Commission on December 21, 1998) |
|
|
|
10.27*
|
|
Sample Option Agreement Dated November 19, 2002 (Incorporated by reference to
Meridians Annual Report on Form 10-K for the Fiscal Year Ended September 30, 2003) |
|
|
|
10.28*
|
|
Agreement Concerning Disability and Death dated September 10, 2003, between Meridian
and William J. Motto (Incorporated by reference to Meridians Annual Report on Form
10-K for the Fiscal Year Ended September 30, 2003) |
|
|
|
10.29*
|
|
Professional Services Agreement dated October 1, 2002 between Meridian and Antonio
Interno (Incorporated by reference to Meridians Annual Report on Form 10-K for the
Fiscal Year Ended September 30, 2003) |
|
|
|
10.31
|
|
Stock Purchase Agreement of OEM Concepts, Inc. by Meridian Bioscience, Inc. dated
January 31, 2005 (Incorporated by reference to Meridians Annual Report on Form 10-K
for the Fiscal Year Ended September 30, 2005) |
|
|
|
10.32*
|
|
Sample Option Agreement dated November 10, 2005 (Incorporated by reference to
Meridians Annual Report on Form 10-K for the Fiscal Year Ended September 30, 2005) |
|
|
|
10.33*
|
|
2004 Equity Compensation Plan, Amended and Restated through January 22, 2008
(Incorporated by reference to Meridians Proxy Statement filed with the Securities and
Exchange Commission on December 19, 2007) |
|
|
|
10.34*
|
|
Fiscal 2006 Officers Compensation Plan, Amended and Restated through January 19, 2006
(Incorporated by reference to Meridians Form 8-K filed with the Securities and
Exchange Commission on January 19, 2006) |
|
|
|
10.35*
|
|
Sample Option Agreement dated November 14, 2007 (Incorporated by reference to
Meridians Annual Report on Form 10-K for the Fiscal Year Ended September 30, 2007) |
|
|
|
10.36*
|
|
Fiscal 2007 Officers Performance Compensation Plan (Incorporated by reference to
Meridians Form 8-K filed with the Securities and Exchange Commission on November 21,
2006) |
|
|
|
10.37
|
|
Loan and Security Agreement among Meridian Bioscience, Inc., Meridian Bioscience
Corporation, Omega Technologies, Inc. Meridian Life Science, Inc. and Fifth Third Bank
dated August 1, 2007 (Incorporated by reference to Meridians Annual Report on Form
10-K for the Fiscal Year Ended September 30, 2007) |
- 76 -
|
|
|
Exhibit Number |
|
Description of Exhibit |
|
|
|
10.37.1
|
|
Amended and Restated Revolving Note with Fifth Third Bank dated August 1, (Incorporated
by reference to Meridians Annual Report on Form 10-K for the Fiscal Year Ended
September 30, 2007) |
|
|
|
10.38*
|
|
Sample Time-Based Restricted Stock Agreement dated November 12, 2009 (Filed herewith) |
|
|
|
10.39*
|
|
Sample Performance Award Restricted Stock Agreement dated November 12, 2009 (Filed
herewith) |
|
|
|
13
|
|
2009 Annual Report to Shareholders (1) |
|
|
|
14
|
|
Code of Ethics (Incorporated by reference to Meridians Annual Report on Form 10-K for
the Fiscal Year Ended September 30, 2003) |
|
|
|
18
|
|
Grant Thornton Preferability Letter (Incorporated by reference to Meridians Annual
Report on Form 10-K for the Fiscal Year Ended September 30, 2007) |
|
|
|
21
|
|
Subsidiaries of the Registrant (Filed herewith) |
|
|
|
23
|
|
Consent of Independent Registered Public Accounting Firm (Filed herewith) |
|
|
|
31.1
|
|
Certification of Principal Executive Officer required by Rule 13a-14(a) (Filed herewith) |
|
|
|
31.2
|
|
Certification of Principal Financial Officer required by Rule 13a-14(a) (Filed herewith) |
|
|
|
32
|
|
Section 1350 Certification of Chief Executive Officer and Chief Financial Officer
(Filed herewith) |
|
|
|
(1) |
|
Only portions of the 2009 Annual Report to Shareholders specifically are incorporated by
reference in this Form 10-K as filed herewith. A supplemental paper copy of the 2009 Annual Report
to Shareholders has been provided to the Securities and Exchange Commission for informational
purposes only. |
|
* |
|
Management Compensatory Contracts |
Meridian will provide shareholders with any exhibit upon the payment of a specified reasonable fee,
which fee shall be limited to Meridians reasonable expenses in furnishing such exhibit.
- 77 -
Pursuant to the requirements of Sections 13 or 15(d) of the Securities Exchange Act of 1934, the
Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto
duly authorized.
|
|
|
|
|
|
MERIDIAN BIOSCIENCE, INC.
|
|
|
By: |
/s/ John A. Kraeutler
|
|
|
|
Date: November 30, 2009 |
|
|
|
John A. Kraeutler
Chief Executive Officer |
|
- 78 -
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed by
the following persons on behalf of the Registrant and in the capacities and on the dates indicated.
|
|
|
|
|
Signature |
|
Capacity |
|
Date |
|
|
|
|
|
/s/ William J. Motto
|
|
Chairman of the Board of Directors
|
|
November 30, 2009 |
|
|
|
|
|
William J. Motto |
|
|
|
|
|
|
|
|
|
/s/ John A. Kraeutler
|
|
Chief Executive Officer, Director
|
|
November 30, 2009 |
|
|
|
|
|
John A. Kraeutler |
|
|
|
|
|
|
|
|
|
/s/ Melissa Lueke
|
|
Executive Vice President, Chief Financial Officer,
|
|
November 30, 2009 |
Melissa Lueke |
|
and Secretary |
|
|
|
|
|
|
|
/s/ James M. Anderson
|
|
Director
|
|
November 30, 2009 |
|
|
|
|
|
James M. Anderson |
|
|
|
|
|
|
|
|
|
/s/ James A. Buzard
|
|
Director
|
|
November 30, 2009 |
|
|
|
|
|
James A. Buzard |
|
|
|
|
|
|
|
|
|
|
|
Director
|
|
November 30, 2009 |
|
|
|
|
|
Gary P. Kreider
|
|
|
|
|
|
|
|
|
|
/s/ David C. Phillips
|
|
Director
|
|
November 30, 2009 |
|
|
|
|
|
David C. Phillips |
|
|
|
|
|
|
|
|
|
/s/ Robert J. Ready
|
|
Director
|
|
November 30, 2009 |
|
|
|
|
|
Robert J. Ready |
|
|
|
|
- 79 -
SCHEDULE II
Meridian Bioscience, Inc.
and Subsidiaries
Valuation and Qualifying Accounts
(Dollars in thousands)
Years Ended September 30, 2009, 2008 and 2007
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at |
|
|
Charged to |
|
|
|
|
|
|
|
|
|
|
Balance at |
|
|
|
Beginning |
|
|
Costs and |
|
|
|
|
|
|
|
|
|
|
End of |
|
Description |
|
of Period |
|
|
Expenses |
|
|
Deductions |
|
|
Other (a) |
|
|
Period |
|
Year Ended September 30, 2009: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Allowance for doubtful accounts |
|
$ |
230 |
|
|
$ |
33 |
|
|
$ |
(26 |
) |
|
$ |
10 |
|
|
$ |
247 |
|
Inventory realizability reserves |
|
|
1,103 |
|
|
|
613 |
|
|
|
(691 |
) |
|
|
|
|
|
|
1,025 |
|
Valuation allowances deferred
taxes |
|
|
466 |
|
|
|
|
|
|
|
|
|
|
|
4 |
|
|
|
470 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended September 30, 2008: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Allowance for doubtful accounts |
|
$ |
258 |
|
|
$ |
38 |
|
|
$ |
(70 |
) |
|
$ |
4 |
|
|
$ |
230 |
|
Inventory realizability reserves |
|
|
1,162 |
|
|
|
551 |
|
|
|
(610 |
) |
|
|
|
|
|
|
1,103 |
|
Valuation allowances deferred
taxes |
|
|
569 |
|
|
|
|
|
|
|
(115 |
) |
|
|
12 |
|
|
|
466 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended September 30, 2007: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Allowance for doubtful accounts |
|
$ |
408 |
|
|
$ |
19 |
|
|
$ |
(200 |
) |
|
$ |
31 |
|
|
$ |
258 |
|
Inventory realizability reserves |
|
|
1,158 |
|
|
|
259 |
|
|
|
(258 |
) |
|
|
3 |
|
|
|
1,162 |
|
Valuation allowances deferred
taxes |
|
|
888 |
|
|
|
|
|
|
|
(390 |
) |
|
|
71 |
|
|
|
569 |
|
|
|
|
(a) |
|
Balances reflect the effects of currency translation |
- 80 -