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, 2010.
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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 NO
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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 NO
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Indicate by check mark whether the registrant: (1) has filed all reports required to be
filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding
12 months, and (2) has been subject to such filing requirements for the past 90 days.
YES NO
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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 NO
þ 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 NO
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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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Accelerated filer o |
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Non-accelerated filer o (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).
YES NO
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The aggregate market value of Common Shares held by non-affiliates as of March 31, 2010
was $807,874,954 based on a closing sale price of $20.37 per share on March 31, 2010. As
of October 31, 2010, 40,677,386 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, 2010 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 2011 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
This Annual Report on Form 10-K contains 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 will be successfully integrated into Meridians operations. There may be
risks that acquisitions may disrupt operations and may pose potential difficulties in employee
retention and there may be additional risks with respect to Meridians ability to recognize the
benefits of acquisitions, including potential synergies and cost savings or the failure of
acquisitions to achieve their plans and objectives. The Company cannot predict the possible impact
of recently-enacted United States healthcare legislation and any 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.
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PART I.
This Annual Report on Form 10-K includes forward-looking statements about our business and results
of operations that are subject to risks and uncertainties. See Forward Looking Statements above.
Factors that could cause or contribute to such differences include those discussed in Item 1A.
Risk Factors. In addition to the risk factors discussed herein, we are also subject to additional
risks and uncertainties not presently known to us or that we currently deem immaterial. If any of
these risks and uncertainties develop into actual events, our business, financial condition or
results of operations could be adversely affected.
Unless the context requires otherwise, references in this Annual Report on Form 10-K to Meridian,
we, us, our, or our company refer to Meridian Bioscience, Inc. and its subsidiaries.
In the discussion that follows, all 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
gastrointestinal, viral, respiratory and parasitic infectious diseases; (ii) the manufacture and
distribution of bulk antigens, antibodies, PCR/qPCR reagents, nucleotides, competent cells and
bioresearch reagents used by researchers and other diagnostic manufacturers; and (iii) the contract
development and manufacture of proteins and other biologicals under cGMP conditions 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 U.S. Diagnostics, European Diagnostics and Life Science. The
U.S. Diagnostics operating segment consists of manufacturing operations in Cincinnati, Ohio, and
the sale and distribution of diagnostic test kits in the U.S. 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; Boca
Raton, Florida; London, England; Luckenwalde, Germany; and Sydney, Australia, and the sale and
distribution of bulk antigens, antibodies, PCR/qPCR reagents, nucleotides, competent cells and
bioresearch reagents domestically and abroad. 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.
Financial information for Meridians operating segments is included in Note 9 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 81% of consolidated net sales for fiscal 2010. 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. The acquisition of the Bioline
group of companies (collectively the Bioline Group) in July 2010 significantly increased the
revenue base for our Life Science operating segment. We expect revenues for our Life Science
operating segment to approximate 24% of consolidated net sales for fiscal 2011.
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., 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.
U.S. Diagnostics Operating Segment
Overview
Our U.S. Diagnostics operating segments business focuses on the development, manufacture, sale and
distribution of diagnostic test kits, primarily for certain gastrointestinal, viral, respiratory
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 $92,020, $98,970 and $88,419 for fiscal
2010, 2009 and 2008, respectively, reflecting a three-year compound annual growth rate of 7%. As
of September 30, 2010, our U.S. Diagnostics operating segment had 284 employees.
Our diagnostic test kits utilize immunodiagnostic and molecular technologies, which test samples of
stool, blood, urine and other body fluids or tissue for the presence 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. Additionally, during 2010 we received U.S. Food and Drug
Administration (FDA) clearance and introduced into the marketplace our
new molecular amplification assay, illumigene® C.difficile. The illumigene®
molecular amplification assay detects the presence of the toxin producing region from the C.
difficile DNA, and provides highly accurate results in under an hour.
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Our diagnostic products are used principally in the detection of gastrointestinal diseases, such as
antibiotic-associated diarrhea (C. difficile), pediatric diarrhea (Rotavirus and Adenovirus) and
stomach ulcers (H. pylori); foodborne diseases such as Enterohemorrhagic E. Coli infection (EHEC)
and Campylobacter jejuni (Campy); viral diseases, such as Mononucleosis, Herpes Simplex, Chicken
Pox and Shingles (Varicella-Zoster) and Cytomegalovirus (organ transplant infections); parasitic
diseases, such as Giardiasis, Cryptosporidiosis and Lyme; and respiratory diseases, such as
Pneumonia, Valley Fever, Influenza and Respiratory Syncytial Virus (RSV). 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.
Sales and Marketing
Our U.S. Diagnostics operating segments sales and distribution network consists of a direct sales
force in the U.S. and Canada and independent distributors in the U.S. and abroad. The direct sales
force consists of 4 management personnel who oversee corporate health accounts and work with
managed-care institutions, and 6 management personnel who oversee 25 technical sales
representatives, 3 inside sales representatives, and independent distributors in over 30 countries.
Our only customers who accounted for 10% or more of consolidated net sales in fiscal 2010, 2009
and 2008 were two independent distributors in the U.S.: Cardinal Healthcare Corporation and Fisher
Scientific. Our sales to Cardinal were $33,821, $37,876 and $31,285 during fiscal 2010, 2009 and
2008, respectively. Our sales to Fisher were $18,204, $19,063 and $16,160 during fiscal
2010, 2009 and 2008, respectively. Currently, we do not have distribution agreements in place with
these customers. However the need for formal distribution
arrangements is assessed on an ongoing basis as our business and
product offerings continue to evolve.
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Consolidation of the U.S. 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 group purchasing organizations 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 DNA amplification, enzyme
immunoassay, immunofluorescence, particle agglutination/aggregation, immunodiffusion, complement
fixation and chemical stains. As a result, we are able to develop and manufacture diagnostic tests
in a variety of formats that satisfy customer needs and preferences, whether in a hospital,
commercial or reference laboratory, or alternate site location. Our product offering consists of
approximately 140 medical diagnostic products.
We had three products that accounted for 28%, 30% and 32% of consolidated net sales in fiscal 2010,
2009 and 2008, 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.
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 U.S. and European patents for this
product.
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Research and Development
Our U.S. Diagnostics operating segments research and development organization consists of 18
research scientists with expertise in biochemistry, immunology, mycology, bacteriology, virology,
parasitology and molecular biology. Research and development expenses for the U.S. Diagnostics
operating segment for fiscal 2010, 2009 and 2008 were $6,565, $7,209 and $4,878, 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 33% of our U.S. Diagnostics
operating segments third-party sales during fiscal 2010.
After nearly four years of exploration and development of a molecular-based diagnostic testing
technology to complement our existing antigen/antibody-based testing technologies, in the third
quarter of 2010, we introduced our new molecular amplification assay, illumigene®
C.difficile to the international markets. Shortly thereafter, early in the fourth quarter of
fiscal 2010, we received clearance from the U.S. Food and Drug Administration (FDA) for the product
and began offering illumigene® C.difficile to our domestic customers. The
illumigene® molecular amplification assay detects the presence of a key toxin producing
region from the C. difficile DNA, and provides highly accurate results in under an hour. We
believe this new molecular assay uniquely positions us in the market to provide a full line of
testing solutions that will meet the needs of both our domestic and international customers.
Having introduced this platform for C. difficile detection, several other infectious diseases have
been identified for future development using this technology. We currently hold registrations to
sell illumigene® in eighteen countries, including the U.S., with registrations pending
in two additional countries.
During fiscal 2008, we launched our first products under our 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.
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Early in the fourth quarter of fiscal 2010 we entered into an exclusive, worldwide product
development and distribution agreement with DiaSorin S.p.A., under which DiaSorin will utilize key
Meridian technology to develop several infectious disease products for use on their
LIAISON® systems. LIAISON is a fully automated, random access system based on
chemiluminescense detection, of which there over three thousand placed in laboratories throughout
the world. The agreement is royalty-based, with the actual royalty amount to be paid to Meridian
dependent upon type of test and specific geographic market. Under the agreement, DiaSorin has
exclusive distribution rights for the developed products in every geographic market except the U.S.
and the U.K., where we retain the option for distribution. The first two products to be developed
under the agreement will be for the detection of C. difficile and H. pylori.
As a world leader in C. difficile testing, we strive to offer our customers a comprehensive C.
difficile product portfolio. During the fourth quarter of fiscal 2010, we launched our Premier C.
difficile GDH enzyme immunoassay product in non-U.S. markets and we have just recently initiated
clinical trials in the United States. This assay provides our customers with a rapid, accurate and
cost-effective screening method for the identification of suspected C. difficile infections.
Manufacturing
Our immunodiagnostic and molecular products require the production of highly specific and sensitive
antigens, antibodies and primers. While we produce substantially all of our own requirements
including monoclonal antibodies and polyclonal antibodies, plus a variety of fungal, bacterial and
viral antigens, currently all of the raw materials used in our illumigene® molecular
product are purchased from outside vendors. We believe that we have sufficient manufacturing and
sourcing capacity for anticipated growth in the near term.
Intellectual Property, Patents and Licenses
We own or license U.S. and foreign patents, most of which are for products manufactured by our U.S.
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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Product Family |
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products |
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2010 |
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2009 |
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H. pylori |
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13 |
% |
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12 |
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Upper respiratory |
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2 |
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4 |
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4 |
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Other |
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2 |
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2 |
% |
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Total patented products |
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12 |
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19 |
% |
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18 |
% |
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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.
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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; however, we
can make no assurances in this regard.
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.
Seasonal Factors and Sporadic Outbreaks
Our principal business is the sale of a broad range of diagnostic test kits for common
gastrointestinal, viral, upper respiratory and parasitic infectious diseases. Certain infectious
diseases may be seasonal in nature, while others may be associated with sporadic outbreaks, such as
foodborne illnesses, or pandemics such as H1N1 influenza. While we believe that the breadth of our
diagnostic product lines reduces the risk that infections subject to seasonality and sporadic
outbreaks will cause significant variability in diagnostic revenues, we can make no assurance that
revenues will not be negatively impacted period over period by such factors.
European Diagnostics Operating Segment
Our European Diagnostics operating segments business focuses on the sale and distribution of
diagnostic test kits, manufactured both by our U.S. Diagnostics operating segment and by
third-party vendors. Approximately 74% of third-party sales for fiscal 2010 for this operating
segment were products purchased from our U.S. Diagnostics operating segment. Third-party sales for
this operating segment were $24,041, $25,870 and $27,980 for fiscal 2010, 2009 and 2008,
respectively. As of September 30, 2010, the European Diagnostics operating segment had 39
employees, including 14 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 near Milan, Italy. The
primary markets and customers for this operating segment are hospitals and reference laboratories.
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The European Diagnostics operating segments functional currency is the Euro. The translation of
Euros into U.S. 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, PCR/qPCR reagents, nucleotides, competent cells and
bioresearch 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 $26,939, $23,434 and $23,240 for fiscal 2010, 2009 and 2008, respectively.
As of September 30, 2010, our Life Science operating segment had approximately 175 employees.
Most of the revenue for our Life Science operating segment currently comes from the manufacture,
sale and distribution of bulk antigens, antibodies, PCR/qPCR reagents, nucleotides, competent cells
and bioresearch reagents used by researchers and other diagnostic companies. During fiscal 2010,
27% 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.
In July 2010, we acquired the Bioline Group and in so doing added important technologies and
capabilities to our Life Science business and complemented our expanding life science product lines
sold into the research, pharmaceutical and commercial diagnostic markets. In addition to
technological capabilities, Bioline also adds proprietary know-how in the production of high-volume
nucleotides and PCR enzymes, as well as a growing portfolio of intellectual property in the form of
patents and licenses.
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 our
immunodiagnostic and molecular biology products, 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 $1,958, $1,635 and $1,477 in fiscal 2010, 2009 and 2008, respectively.
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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, OEM Concepts in fiscal 2005, and most
recently, the Bioline Group in July 2010). 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.
Immunodiagnostic products such as 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.
Molecular biology products such as PCR/qPCR reagents, nucleotides and competent cells are marketed
primarily to research customers. These products are typically sold in small quantities.
Research and Development
Our Life Science operating segments research and development organization consists of 15 research
scientists. Research and development expenses for our Life Science operating segment for fiscal
2010, 2009 and 2008 were $2,005, $1,219 and $1,305, 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.
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The Meridian Life Science facilities are ISO 9001:2000 certified and EC 1774:2002 approved, where
appropriate and as required.
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 Cepheid, Quidel Corporation and
Alere Inc.
C. difficile is one of our primary disease categories. Over the last 24-30 months, considerable
confusion has developed in this market over the relative benefits of the various testing 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. With the development and launch of our
illumigene® molecular C. difficile product, we believe we are well-armed to combat these
competitive pressures. Following the introduction of illumigene® C. difficile, we are
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.
- 13 -
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. Despite our recent
acquisition of the Bioline Group, we cannot provide any assurance that we will consummate any
additional acquisitions in the future nor can we provide any assurance that any acquisitions will
accomplish these objectives. However, we expect that the potential for acquisitions will continue
to provide opportunities 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 $43,391 or
30% of consolidated fiscal 2010 sales, $41,438 or 28% of consolidated fiscal 2009 sales and $44,430
or 32% of consolidated fiscal 2008 sales. Domestic exports for our U.S. Diagnostics and Life
Science operating segments were $17,851, $15,568 and $16,450 in fiscal 2010, 2009 and 2008,
respectively. We expect to continue to look to international markets as a source of new revenues
and growth in the future. See Notes 7 and 9 to the Consolidated Financial Statements for
information concerning sales, long-lived assets and deferred tax assets by country.
Environmental
We are a conditionally exempt, small quantity generator of hazardous waste and have a U.S. 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.
- 14 -
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 fiscal 2010, 2009 and 2008, we incurred $8,570, $8,428 and $6,183, respectively, in research
and development expenses. We expect to continue to invest in our research and development
activities.
We may be unable to successfully integrate operations or to achieve expected cost savings from
acquisitions we make.
One of our main growth strategies is the acquisition of companies and/or products. Although
additional acquisitions of companies and products may enhance the opportunity to increase net
earnings over time, such acquisitions could result in greater administrative burdens, increased
exposure to the uncertainties inherent in marketing new products and financial risks of additional
operating costs. The principal benefits expected to result from any acquisitions we make will not
be achieved fully unless we are able to successfully integrate the
operations of the acquired entities with our operations and realize the anticipated synergies, cost
savings and growth opportunities from integrating these businesses into our existing businesses. We
cannot provide any assurance that we will be able to identify and complete additional acquisitions
on terms we consider favorable or that, if completed, will be successfully integrated into our
operations.
- 15 -
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 U.S. Diagnostic operating segments sales through two distributors were 57% and 58%,
respectively, of the U.S. Diagnostics operating segments total sales for fiscal 2010 and 2009, or
36% and 38%, respectively, of our consolidated sales for fiscal 2010 and 2009. 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
gastrointestinal, viral, upper respiratory and parasitic infectious diseases. Certain infectious
diseases may be seasonal in nature, while others may be associated with sporadic outbreaks, such as
foodborne illnesses, or pandemics such as H1N1 influenza. While we believe that the breadth of our
diagnostic product lines reduces the risk that infections subject to seasonality and sporadic
outbreaks will cause significant variability in diagnostic revenues, we can make no assurance that
revenues will not be negatively impacted period over period by such factors.
Changing Diagnostic Market Conditions
Changes in the 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. Consolidation in the U.S. healthcare industry has also led
to the creation of group purchasing organizations (GPOs) that aggregate buying power for hospital
groups and put pressure on our selling prices. Due to such consolidation, we may not be able to
enter into and/or sustain contractual or other marketing or
distribution arrangements on a satisfactory commercial basis with institutional customers and GPOs,
which could adversely affect our results of operations.
- 16 -
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. Following years of increasing pressure, during 2010
the U.S. government enacted comprehensive healthcare reform. At present, given the infancy of the
enacted reform, we are unable to predict what effect the legislation might ultimately 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.
In addition, this legislation established a 2.3% excise tax on the sales of medical devices that
retail for more than one hundred dollars beginning in 2013. At existing sales levels in our U.S.
markets, this would result in an annual excise tax in excess of $2,000 for our company. It is
unknown at the present time whether this cost can be passed on to customers.
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
27% and 30%, respectively, of the Life Science operating segments total sales for fiscal 2010 and
fiscal 2009, or 5% of our consolidated sales for each of fiscal 2010 and fiscal 2009. 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 four other significant customers who purchase antigens,
antibodies and reagents, which together comprised 13% and 10%, respectively, of the operating
segments total sales for fiscal 2010 and 2009. 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.
- 17 -
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.
Over the past two years, 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 the success and market
acceptance of our own molecular-based product, illumigene® C. difficile, which we
launched internationally in the third quarter of 2010 and domestically in the fourth quarter.
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 30% of our net sales
for fiscal 2010 and approximately 28% of our net sales for fiscal 2009 were attributable to
international markets. For fiscal 2010, 48% of our international sales were made in Euros and 49%
were made in U.S. dollars, with the remaining 3% being a combination of the British pound and the
Australian dollar, as a result of the acquisition of the Bioline Group. We are subject to the
risks associated with fluctuations in the exchange rates for the Australian dollar, British pound
and Euro to the U.S. dollar. We are also subject to other risks associated with international
operations, including longer customer payment cycles, tariff regulations, requirements for export
licenses, instability of foreign governments, and governmental requirements with respect to the
importation and distribution of medical devices and immunodiagnostic and molecular biology
reagents, all of which may vary by country.
Risks Affecting our Manufacturing Operations
We are subject to comprehensive regulation, and our ability to earn profits may be restricted by
these regulations.
Medical device diagnostics and the manufacture, sale and distribution of bulk antigens, antibodies
and reagents are highly regulated industries. We cannot provide any assurance that we will be able
to obtain necessary governmental clearances or approvals or timely clearances or approvals to
market future products in the United States and other countries. Costs and difficulties in
complying with laws and regulations administered by the U.S. Food and Drug Administration, the U.S.
Department of Agriculture, the U.S. Department of Commerce, the U.S. Drug Enforcement Agency, 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 U.S. Food and Drug
Administration.
- 18 -
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; Saco, Maine; London, England; Luckenwalde, Germany; and Sydney, Australia facilities
comprised 74% of our Diagnostics revenues and 73% 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 and product components. The operations of our
facilities or these third-party manufacturing facilities could be adversely affected by power
failures, natural or other disasters, such as earthquakes, floods, tornadoes or terrorist threats.
Although we carry insurance to protect against certain business interruptions at our facilities,
there can be no assurance that such coverage will be adequate or that such coverage will continue
to remain available on acceptable terms, if at all. Any significant interruption in the Companys
or 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 Alere Inc. These products represented 6%, 13% and 14%,
respectively, of third-party sales for our U.S. Diagnostics operating segment in fiscal 2010, 2009
and 2008, 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 11%, 7% and 5% of third-party sales for our US
Diagnostics operating segment in fiscal 2010, 2009 and 2008, respectively.
- 19 -
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.
- 20 -
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.
We face risks related to global economic conditions.
We currently generate significant operating cash flows, which combined with access to the credit
markets provides us with discretionary funding capacity for research and development and other
strategic activities. 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 global economic conditions deteriorate significantly, our business could be
negatively impacted, including such areas as reduced demand for our products from a slow-down in
the general economy, supplier or customer disruptions resulting from tighter credit markets and/or
temporary interruptions in our ability to conduct day-to-day transactions through our financial
intermediaries involving the payment to or collection of funds from our customers, vendors and
suppliers.
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.
- 21 -
ITEM 1B.
UNRESOLVED STAFF COMMENTS
None.
ITEM 2.
PROPERTIES
Our corporate offices, U.S. Diagnostics manufacturing facility and U.S. 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 an additional 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 U.S. Diagnostics operating segment. This facility consists of
approximately 22,000 square feet on 3.5 acres of land. We are in the process of expanding a
portion of our US operations into this space and anticipate completion of this expansion during the
next three months.
Our European Diagnostics distribution center in Italy conducts its operations in a two-story
building near 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, as well as the recently-acquired Bioline Group facilities located in
Boston, Massachusetts; London, England; Luckenwalde, Germany; and Sydney, Australia. 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. Following are details of the
Bioline Group facilities, all of which are leased: Boston approximately 10,000 square feet of
sales and warehouse space; London approximately 9,000 square feet of sales, warehouse,
distribution, research and development, manufacturing and administrative office space; Luckenwalde
approximately 9,000 square
feet of sales, warehouse and manufacturing space; Sydney approximately 3,000 square feet of
sales, warehouse, research and development and manufacturing space.
- 22 -
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 material provision has been made in
the accompanying consolidated financial statements for these matters.
ITEM 4.
(REMOVED AND RESERVED)
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 15 through 21 of this Annual Report .
Common Stock Information on the inside back cover of the Annual Report to Shareholders for 2010
and Quarterly Financial Data relating to our dividends in Note 11 to the Consolidated Financial
Statements are incorporated herein by reference. There are no restrictions on cash dividend
payments.
Historically, our cash dividend policy has been to set the indicated annual dividend rate between
75% and 85% of each fiscal years expected net earnings. However, during fiscal 2010, a year of
significant investment in our foundation for the future (e.g., illumigene® molecular
technology development/launch, Bioline Group acquisition, etc.), our indicated dividend rate of
$0.76 per share was 117% of diluted earnings per share. Over the next several fiscal years, we
expect our dividend payout ratio to come into line with our historical policy of 75% to 85%, as
expected earnings contributions are realized from our illumigene® molecular technology
and the acquisition of the Bioline Group. 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.
- 23 -
We paid dividends of $0.74 per share, $0.65 per share and $0.53 per share in fiscal 2010, 2009 and
2008, respectively.
As of September 30, 2010, there were approximately 1,000 holders of record and approximately 19,700
beneficial owners of our common shares.
ITEM 6.
SELECTED FINANCIAL DATA
Incorporated by reference from inside front cover of the Annual Report to Shareholders for 2010.
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 15 through 21 of this Annual Report.
In the discussion that follows, all amounts are in thousands (both tables and text), except per
share data.
Results of Operations:
Fourth Quarter
Net earnings for the fourth quarter of fiscal 2010 decreased 40% to $5,322, or $0.13 per diluted
share, from net earnings for the fourth quarter of fiscal 2009 of $8,930, or $0.22 per diluted
share. This decrease primarily reflects decreased sales coupled with transaction costs related to
the acquisition of the Bioline Group ($822, or $0.02 per diluted share). The effects of these
factors were partially offset by the management of discretionary spending and the resulting
decreases in Research & Development and Selling & Marketing expenses. Sales for the fourth quarter
of fiscal 2010 were $35,539, a decrease of $6,922, or 16%, compared to the fourth quarter of fiscal
2009.
Sales for the U.S. Diagnostics operating segment for the fourth quarter of fiscal 2010 decreased
25% compared to the fourth quarter of fiscal 2009, reflecting decreased sales in our C. difficile
product family, along with the impact on 2009 of the novel A (H1N1) influenza outbreak and the
abrupt halt of the outbreak in December 2009. Fourth quarter 2010 sales for our European
Diagnostics operating segment decreased 25% compared to the fourth quarter of fiscal 2009, while,
as a result of the Bioline Group acquisition, sales for our Life Science segment experienced a 30%
increase in sales during this period. Excluding the effect of the Bioline Group, sales of our Life
Science operating segment decreased by 2% during the fourth quarter of fiscal 2010 compared to the
fourth quarter of fiscal 2009. On an organic basis, which excludes the effects of currency
translation, sales for our European Diagnostics operating segment decreased 18% during the fourth
quarter, reflecting the ongoing
effects of significant competitive pressures in the C. difficile product family and the abrupt halt
of the novel A (H1N1) influenza outbreak in late 2009, similar to that experienced in the U.S.
- 24 -
Fiscal Year
Net earnings for fiscal 2010 decreased 19% to $26,647 or $0.65 per diluted share from net earnings
for fiscal 2009 of $32,759 or $0.80 per diluted share. Net earnings for fiscal 2010 include
$1,240, or $0.03 per diluted share, of Bioline Group transaction costs. Results of operations for
fiscal 2010 compared to fiscal 2009 are discussed below.
Non-GAAP Information
The tables below provide information on net earnings, basic earnings per share and diluted earnings
per share, excluding the effect of transaction costs associated with the acquisition of the Bioline
Group, as well as reconciliations to amounts reported under U.S. 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 impact of one-time transaction costs related to the
acquisition of the Bioline Group; 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. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2010 |
|
|
2009 |
|
|
2008 |
|
Net Earnings - |
|
|
|
|
|
|
|
|
|
|
|
|
U.S. GAAP basis |
|
$ |
26,647 |
|
|
$ |
32,759 |
|
|
$ |
30,202 |
|
Transaction costs for Bioline Group acquisition |
|
|
1,240 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Excluding Bioline transaction costs |
|
$ |
27,887 |
|
|
$ |
32,759 |
|
|
$ |
30,202 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Earnings per Basic Common Share - |
|
|
|
|
|
|
|
|
|
|
|
|
U.S. GAAP basis |
|
$ |
0.66 |
|
|
$ |
0.81 |
|
|
$ |
0.75 |
|
Transaction costs for Bioline Group acquisition |
|
|
0.03 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Excluding Bioline transaction costs |
|
$ |
0.69 |
|
|
$ |
0.81 |
|
|
$ |
0.75 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Earnings per Diluted Common Share - |
|
|
|
|
|
|
|
|
|
|
|
|
U.S. GAAP basis |
|
$ |
0.65 |
|
|
$ |
0.80 |
|
|
$ |
0.74 |
|
Transaction costs for Bioline Group acquisition |
|
|
0.03 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Excluding Bioline transaction costs |
|
$ |
0.68 |
|
|
$ |
0.80 |
|
|
$ |
0.74 |
|
|
|
|
|
|
|
|
|
|
|
- 25 -
Revenue Overview:
Our Diagnostics operating segments provide the largest share of our consolidated revenues, 81%, 84%
and 83% for fiscal 2010, 2009 and 2008, respectively. Sales from our four focus families (C.
difficile, H. pylori, Foodborne and Upper Respiratory) comprised 69% of our Diagnostics operating
segments revenues during fiscal 2010.
Overall revenue change for fiscal 2010 for our Diagnostics operating segments was a negative 7%,
largely due to a relatively mild worldwide flu season in fiscal 2010 compared to 2009, including
the effects of the world-wide outbreak of novel A (H1N1) influenza, which primarily occurred during
fiscal 2009. Further contributing to the year-over-year sales decline was the fact that sales of
our C. difficile family of products continued to be negatively impacted by significant competitive
pressures and ongoing confusion surrounding the various testing methods, factors which we believe
will be countered by our recently-introduced illumigene® molecular C. difficile product.
Partially offsetting the effects of the declines in these products were sales increases in our H.
pylori and Foodborne family of products of 10% and 32%, respectively, compared to fiscal 2009. On
an organic basis, our European Diagnostic operating segments sales declined 7% in fiscal 2010, due
in large part to significant competitive pressures on sales of our C. difficile product. This
compared to 1% growth in the segments organic sales during fiscal 2009, which was driven by volume
increases in upper respiratory related to the novel A (H1N1) influenza outbreak.
C. difficile Products
During the third quarter of fiscal 2010, we launched our illumigene® molecular C.
difficile product in non-U.S. markets, and launch of the product into U.S. markets followed in the
fourth quarter of 2010, upon receiving FDA clearance. As a result, we currently have approximately
125 customer accounts and others that are evaluating our illumigene® molecular C.
difficile product. We expect sales of the product, which totaled $475 in 2010, to grow
significantly in fiscal 2011.
As a result of competitive pressures in this disease family over the last several years from new
competitive products, including molecular assays, during fiscal 2010 we experienced declines in the
sales of our C. difficile products. Sales of C. difficile products decreased 19% for both of our
Diagnostics operating segments during fiscal 2010, compared to a 1% decline in fiscal 2009. The C.
difficile market also continues to experience considerable confusion around the relative benefits
of the various test methods available (toxin testing, antigen testing and molecular testing). With
the launch of our molecular product, we believe we are in a unique position to offer a full line of
testing solutions to our clinical laboratory customers around the world to counter the competitive
pressures surrounding this market.
- 26 -
Upper Respiratory Products
During fiscal 2010, upper respiratory sales for our Diagnostics operating segments decreased 31%
compared to fiscal 2009, following a 24% year-over-year increase from fiscal 2008 to fiscal 2009.
This dramatic sales fluctuation for this family of products was driven by the abrupt halt, in
December 2009, of the outbreak of the 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 also created an increased interest in influenza testing in European markets where
rapid testing has not been traditionally performed, resulting in significant revenue growth in
fiscal 2009, which, similar to U.S. markets, has declined in fiscal 2010. At present,
significant seasonal influenza activity has yet to emerge, and we do
not expect a significant revenue contribution from these products in
fiscal 2011.
Foodborne Products
During fiscal 2010, sales of our foodborne products increased approximately 32% for our U.S.
Diagnostics operating segment and approximately 28% for our European Diagnostics operating segment
on an organic basis. As was experienced in fiscal 2009, the revenue increases in this product
family continues to reflect the volume growth in our new foodborne products launched over the last
few years (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
approaching a $14,000 product family. This disease family is expected to generate significant
sales growth in fiscal 2011.
H. pylori Products
During fiscal 2010, sales of our H. pylori products grew 15% for our U.S. Diagnostics operating
segment and 1% for our European Diagnostics operating segment on an organic basis, compared to the
year-over-year sales level increases these operating segments experienced in 2009 of 10% and 2%,
respectively. The increases for our U.S. Diagnostics operating segment continue to reflect the
benefits of our partnerships with managed care companies in promoting the health and economic
benefits of a test and treat strategy, and the fact that such a strategy is beginning to move
physician behavior away from serology-based testing to direct antigen testing. The modest levels
of growth for our European Diagnostics operating segment reflect the ongoing impact of pricing
pressures from competitive products in European markets.
Group Purchasing Organizations
In our U.S. Diagnostics operating segment, consolidation of the U.S. healthcare industry over the
last several years has led to the creation of group purchasing organizations (GPOs) that aggregate
buying power for hospital groups and put pressure on our selling prices. We have multi-year supply
agreements with several GPOs. During fiscal 2010, we experienced approximately $2,700 in
unfavorable price variance, as a result of these
agreements. However, these agreements help secure our products with these customers and have led
to new business. While in the near term this has negatively impacted gross profit, further
increases in volumes are expected from these contracts.
- 27 -
Foreign Currency
Currency translation had virtually no impact on the fiscal 2010 consolidated sales results,
compared to resulting in $2,419 of currency translation losses in fiscal 2009 and $2,743 of gains
in fiscal 2008.
Life Science Operating Segment
Excluding the impact of our July 2010 acquisition of the Bioline Group, sales for our Life Science
operating segment increased 6% for fiscal 2010 compared to fiscal 2009; 15% including Bioline Group
sales. This increase largely reflects buying patterns of our two largest diagnostic manufacturing
customers, who accounted for 27% of the Life Science operating segments sales in fiscal 2010
compared to 30% in fiscal 2009. Excluding the impact of Bioline Group transaction costs and the
Bioline Groups results since the date of acquisition, we experienced a 5% improvement in the
operating income contribution of this operating segment in fiscal 2010 compared to fiscal 2009.
Significant Customers
Our U.S. Diagnostic operating segments sales through two distributors were 57% of the U.S.
Diagnostics operating segments total sales, or 36% of consolidated sales, for fiscal 2010. This
compares to fiscal 2009, in which sales through these distributors comprised 58% of U.S.
Diagnostics operating segment sales and 38% of consolidated sales.
Our Life Science operating segments sales of purified antigens and reagents to two customers were
27% of the Life Science operating segments total sales for fiscal 2010 or 5% of our consolidated
sales for fiscal 2010, compared to 30% and 5% of fiscal 2009 Life Science operating segment and
consolidated sales, respectively.
Operating Segment Revenues:
Our reportable operating segments are U.S. Diagnostics, European Diagnostics and Life Science. The
U.S. Diagnostics operating segment consists of manufacturing operations in Cincinnati, Ohio, and
the sale and distribution of diagnostic test kits in the U.S. 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; Boca
Raton, Florida; London, England; Luckenwalde, Germany; and Sydney, Australia, and the sale and
distribution of bulk antigens, antibodies, PCR/qPCR reagents, nucleotides, competent cells and
bioresearch reagents domestically and abroad. 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.
- 28 -
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.
Revenues for each of our operating segments are shown below.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2010 vs. |
|
|
2009 vs. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2009 |
|
|
2008 |
|
|
|
2010 |
|
|
2009 |
|
|
2008 |
|
|
Inc (Dec) |
|
|
Inc (Dec) |
|
U.S. Diagnostics |
|
$ |
92,020 |
|
|
$ |
98,970 |
|
|
$ |
88,419 |
|
|
|
(7) |
% |
|
|
12 |
% |
European Diagnostics |
|
|
24,041 |
|
|
|
25,870 |
|
|
|
27,980 |
|
|
|
(7) |
% |
|
|
(8) |
% |
Life Science |
|
|
26,939 |
|
|
|
23,434 |
|
|
|
23,240 |
|
|
|
15 |
% |
|
|
1 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Consolidated |
|
$ |
143,000 |
|
|
$ |
148,274 |
|
|
$ |
139,639 |
|
|
|
(4) |
% |
|
|
6 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
International - |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. Diagnostics |
|
$ |
6,268 |
|
|
$ |
5,657 |
|
|
$ |
6,643 |
|
|
|
11 |
% |
|
|
(15) |
% |
European Diagnostics |
|
|
24,041 |
|
|
|
25,870 |
|
|
|
27,980 |
|
|
|
(7) |
% |
|
|
(8) |
% |
Life Science |
|
|
13,082 |
|
|
|
9,911 |
|
|
|
9,807 |
|
|
|
32 |
% |
|
|
1 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
43,391 |
|
|
$ |
41,438 |
|
|
$ |
44,430 |
|
|
|
5 |
% |
|
|
(7) |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
% of total sales |
|
|
30 |
% |
|
|
28 |
% |
|
|
32 |
% |
|
|
|
|
|
|
|
|
Gross Profit:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2010 vs. |
|
|
2009 vs. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2009 |
|
|
2008 |
|
|
|
2010 |
|
|
2009 |
|
|
2008 |
|
|
Inc (Dec) |
|
|
Inc (Dec) |
|
Gross Profit |
|
$ |
88,475 |
|
|
$ |
92,783 |
|
|
$ |
86,480 |
|
|
|
(5) |
% |
|
|
7 |
% |
Gross Profit Margin |
|
|
62 |
% |
|
|
63 |
% |
|
|
62 |
% |
|
|
(1) |
% |
|
|
1 |
% |
The relative stability in our gross profit margins from 2008 to 2010 reflects the ongoing
efficiencies from automation in our U.S. Diagnostics manufacturing plant and a continued favorable
mix of product sales between our higher margin manufactured products and the lower margin
third-party influenza and RSV products within the upper respiratory product family. Manufacturing
efficiency improvements at our Memphis, Tennessee facility also contributed to year-over-year
improvements in gross profit in fiscal 2009 compared to fiscal 2008.
GPO contracts also impacted our gross profit margins during fiscal 2010. These contracts provide
customers with favorable pricing based on purchase volume commitments of Meridian products. During
fiscal 2010, we
experienced approximately $2,700 in unfavorable price variance, as a result of these agreements.
However, these agreements help secure our products with these customers and have led to new
business. While in the near term this has negatively impacted gross profit, further increases in
volumes are expected from these contracts.
- 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.
Operating Expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
General & |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Administrative |
|
|
|
|
|
|
Research & |
|
|
Selling & |
|
|
and Transaction |
|
|
Total Operating |
|
|
|
Development |
|
|
Marketing |
|
|
Costs |
|
|
Expenses |
|
2008 Expenses |
|
$ |
6,183 |
|
|
$ |
18,770 |
|
|
$ |
17,177 |
|
|
$ |
42,130 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
% of Sales |
|
|
4 |
% |
|
|
13 |
% |
|
|
12 |
% |
|
|
30 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fiscal 2009
Increases
(Decreases): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. 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 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fiscal 2010
Increases
(Decreases): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. Diagnostics |
|
|
(644 |
) |
|
|
(786 |
) |
|
|
1,370 |
|
|
|
(60 |
) |
European Diagnostics |
|
|
|
|
|
|
(205 |
) |
|
|
277 |
|
|
|
72 |
|
Life Science |
|
|
786 |
|
|
|
513 |
|
|
|
2,022 |
|
|
|
3,321 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2010 Expenses |
|
$ |
8,570 |
|
|
$ |
18,757 |
|
|
$ |
20,010 |
|
|
$ |
47,337 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
% of Sales |
|
|
6 |
% |
|
|
13 |
% |
|
|
14 |
% |
|
|
33 |
% |
% Increase (Decrease) |
|
|
2 |
% |
|
|
-2 |
% |
|
|
22 |
% |
|
|
8 |
% |
Operating expenses for the U.S. Diagnostics operating segment decreased $60 for fiscal 2010
compared to fiscal 2009 and increased $2,529 for fiscal 2009 compared to fiscal 2008. The overall
net decrease in fiscal 2010 reflected the combined effects of: (i) decreased research and
development spending as a result of completing the development of our molecular illumigene® C. difficile product, which was launched during fiscal 2010, and comparatively higher
clinical trial costs for certain immunoassay products in 2009; (ii) decreased sales and marketing
expenses due to lower C. difficile and Upper Respiratory product sales resulting in lower bonus and
commission costs for our sales organization; and (iii) increased general and administrative
expenses as a result of higher compensation costs, including stock based compensation costs related
to time-vested restricted stock granted in November 2009. The increase in fiscal 2009 is primarily
attributable to illumigene® C. difficile development costs, additional salaries and
benefits related to planned headcount additions and 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 levels for fiscal 2009.
- 30 -
Operating expenses for the European Diagnostics operating segment increased $72 for fiscal 2010
compared to fiscal 2009 and decreased $341 for fiscal 2009 compared to fiscal 2008. The fiscal
2009 decrease was primarily attributable to currency fluctuations.
Operating expenses for the Life Science Operating segment increased $3,321 for fiscal 2010 compared
to fiscal 2009 and decreased $314 for fiscal 2009 compared to fiscal 2008. The increase in 2010
resulted primarily from increased salaries and benefits related to filling open positions,
increased research and development resource allocations, the addition of the Bioline Groups
operating expenses of $1,397 and the Bioline Group transaction costs, which were $1,240. 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 2010, 2009 and 2008 was $1,866,
$1,092 and $1,772, 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, in November 2009, we granted restricted shares and
restricted units to certain employees, with half of each employees grant being time-vested
restricted shares or restricted units vesting in total in four years, and the remaining half being
subject to attainment of a specified earnings target for fiscal 2010. Dividends were paid on these
shares throughout fiscal 2010. While the 2010 earnings target was not met, on September 30, 2010,
the Compensation Committee of the Board of Directors chose to convert the performance-based
restricted shares to time-vested restricted shares vesting in total after four years in recognition
of the achievement in 2010 of several strategic initiatives that position the Company for future
growth. Expense totaling $472 was recorded in fiscal 2010 as a result of this conversion, and is
included in the total amount of stock-based compensation set forth above.
Operating Income
Operating income decreased 16% and increased 10% in fiscal 2010 and 2009, respectively, as a result
of the factors discussed above.
- 31 -
Other Income and Expense
Interest income was $124, $456 and $1,533, for fiscal 2010, 2009 and 2008, respectively. The
decreases during fiscal 2010 and fiscal 2009 were primarily driven by lower interest yields due to
a higher concentration of investments in money market funds in fiscal 2010 and lower interest rates
in the current interest rate environment. Fiscal 2010 interest earnings were also impacted by the
use of cash to acquire the Bioline Group early in the fourth quarter.
Income Taxes
The effective rate for income taxes was 36%, 34% and 34% for fiscal 2010, 2009 and 2008,
respectively. The increase in the effective tax rate for fiscal 2010 was primarily attributable to
the non-deductible nature of Bioline Group transaction costs and the expiration of the Federal
research and experimentation tax credit effective December 31, 2009.
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 2010, 2009 or 2008.
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 2010, were
invested in a non-interest bearing bank deposit account, overnight repurchase agreements,
institutional money-market mutual funds and until their sale during the third quarter of fiscal
2010, tax-exempt auction-rate securities. We used $23,849 from our investment portfolio to
complete the acquisition of the Bioline Group.
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.
- 32 -
During the third quarter of fiscal 2010, we sold all of our investment in student loan auction-rate
securities to UBS AG via our Auction Rate Security Rights, and received par value of $7,275, plus
accrued interest.
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.
Fluctuations in overall stock market valuations 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. As of
November 1, 2010, our stock price was $22.69 per share, compared to our book value per share of
$3.38 as of September 30, 2010. This relationship, stock price trading at 6.7x book value, is an
indicator that the fluctuation in overall stock market valuations and its impact on our stock price
has not been a triggering event for impairment of our goodwill and other long-lived assets.
Net cash provided by operating activities decreased 4% to $31,213 in fiscal 2010. This decrease
was primarily attributable to lower sales and earnings levels, timing of payments with suppliers
and the effect of the Bioline Groups operations.
Net cash used for investing activities was $17,812 for fiscal 2010 compared to $3,280 for fiscal
2009. This increase was primarily attributable to the acquisition of the Bioline Group and
increased purchases of property, plant and equipment in fiscal 2010, partially offset by cash
received from the third quarter sale of our student loan auction-rate securities.
Net cash used for financing activities was $29,190 for fiscal 2010 compared to $24,636 for fiscal
2009. This increase was primarily attributable to a 14% increase in dividend payments and a
decrease in proceeds and tax benefits from the exercise of stock options. Dividend payments in
fiscal 2010 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.
- 33 -
Capital Resources
We have a $30,000 credit facility with a commercial bank which expires September 15, 2012. As of
November 29, 2010, there were no borrowings outstanding under this facility. We did not have any
borrowing under this facility during fiscal 2010 or 2009.
Our capital expenditures are estimated to range between approximately $6,000 to $9,500 for
fiscal 2011, with the actual amount depending upon actual operating results and the phasing of
certain projects. Such expenditures 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 costs associated with production line automation in Cincinnati, facilities expansions in
Cincinnati and Memphis, computer system and software purchases for the Bioline Group, and
instrumentation to support the illumigene® product launch.
Known Contractual Obligations:
Known contractual obligations and their related due dates were as follows as of September 30, 2010:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Less than |
|
|
|
|
|
|
|
|
|
|
More than |
|
|
|
Total |
|
|
1 Year |
|
|
1-3 Years |
|
|
4-5 Years |
|
|
5 Years |
|
Operating leases (1) |
|
$ |
2,385 |
|
|
$ |
935 |
|
|
$ |
1,396 |
|
|
$ |
54 |
|
|
$ |
|
|
Purchase obligations (2) |
|
|
13,375 |
|
|
|
13,004 |
|
|
|
371 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Uncertain income tax
positions liability and
interest (3) |
|
|
725 |
|
|
|
725 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
16,485 |
|
|
$ |
14,664 |
|
|
$ |
1,767 |
|
|
$ |
54 |
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
Meridian and its subsidiaries are lessees of (i) office and warehouse buildings in Cincinnati, Boston,
Florida, Australia, Belgium, France, Holland, Germany and the U.K.; (ii) automobiles for use by the
diagnostic direct sales forces in the U.S. 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, 2010, our liabilities for uncertain tax positions and related interest and
penalties were $496 and $229, 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. |
- 34 -
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 14%). Meridian expects that payments
under these agreements will amount to approximately $2,400 in fiscal 2011. These royalty payments
primarily relate to the U.S. 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 remaining payments of
up to approximately $3,200 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. Since
entering into this agreement, we have made payments totaling $392.
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, 2010, 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.
- 35 -
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. Additionally, as a result of the recent Bioline Group acquisition, we are
exposed to foreign currency risks related to the Bioline Groups operations in Australia
(Australian dollar), Germany (Euro), and the U.K. (British pound). Assessing foreign currency
exposures is a component of our overall ongoing risk management process, with such currency risks
managed as we believe appropriate.
Concentration of Customers/Products Risk
Our U.S. Diagnostic operating segments sales through two distributors were 57% of the U.S.
Diagnostics operating segments total sales or 36% of consolidated sales for fiscal 2010. Three
internally developed products, PremierTM Platinum HpSA PLUS, PremierTM Toxins
A&B, and ImmunoCard® Toxins A&B, accounted for 33% of our U.S. Diagnostics operating
segments third-party sales during fiscal 2010. These same three products accounted for 38% of our
European Diagnostics operating segments third-party sales and 28% of our consolidated sales for
fiscal 2010.
Our Life Science operating segments sales of purified antigens and reagents to two customers were
27% of the Life Science operating segments total sales for fiscal 2010 or 5% of our consolidated
sales for fiscal 2010. Our Life Science operating segment has four other significant customers who
purchase antigens, antibodies and reagents, which together comprised 13% of the operating segments
total sales for fiscal 2010.
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 U.S. 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 data provided by these distributors, estimates of inventories of
our products held by these distributors, historical statistics, current trends and other factors.
Changes to these rebate accruals are recorded in the period that they become known.
- 36 -
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 customer pricing.
Pricing is often subject to 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 2010, 2009 or 2008 indicating that the carrying value of such assets may
not be recoverable.
- 37 -
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, U.S. deferred tax liabilities on such earnings have
not been recorded. We believe that such U.S. taxes would be largely offset by foreign tax credits
for taxes paid locally in Italy.
- 38 -
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.
Recent Accounting Pronouncements:
In October 2009, the Financial Accounting Standards Board issued ASU 2009-13, Multiple-Deliverable
Revenue Arrangements. This amended guidance enables companies to account for products or services
(deliverables) separately rather than as a combined unit in certain circumstances. Accounting
Standards Codification Subtopic 605-25, Revenue Recognition: Multiple-Element Arrangements,
establishes the accounting and reporting guidance for arrangements under which the vendor will
perform multiple revenue-generating activities. The Subtopic addresses how to separate deliverables
and how to measure and allocate arrangement consideration to one or more units of accounting. The
amended guidance will be effective prospectively for revenue arrangements entered into or
materially modified in fiscal years beginning on or after June 15, 2010 or our fiscal year 2011. We
do not expect any impact on our consolidated results of operations, cash flows or financial
position when this amended guidance is adopted.
Additionally, see Note 1 (n) 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.
- 39 -
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.
- 40 -
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, 2010.
The Companys assessment of and conclusion on the effectiveness of its internal control over
financial reporting did not include the internal controls of the Bioline Group, which was acquired
on July 20, 2010 and included in the 2010 consolidated financial statements. This acquired
companys total assets and revenues constituted 19% and 1%, respectively, of the Companys related
consolidated financial statement amounts as of and for the year ended September 30, 2010.
The Companys independent registered public accounting firm has issued an attestation report on the
registrants internal control over financial reporting.
|
|
|
|
|
/s/ John A. Kraeutler
|
|
|
|
/s/ Melissa A. Lueke |
|
|
|
|
|
John A. Kraeutler
|
|
|
|
Melissa A. Lueke |
Chief Executive Officer
|
|
|
|
Executive Vice President and |
November 29, 2010
|
|
|
|
Chief Financial Officer |
|
|
|
|
November 29, 2010 |
- 41 -
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, 2010 and 2009, and the related consolidated
statements of operations, shareholders equity, and cash flows for each of the three years in the
period ended September 30, 2010. 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,
2010, 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. Our
audit of, and opinion on, Meridian Bioscience, Inc.s internal control over financial reporting
does not include internal control over financial reporting of the Bioline Group, a group of wholly
owned subsidiaries, whose financial statements reflect total assets and revenues constituting 19%
and 1%, respectively, of the related consolidated financial statement amounts as of and for the
year ended September 30, 2010. As indicated in Managements Report on Internal Control Over
Financial Reporting, the Bioline Group was acquired on July 20, 2010 and therefore, managements
assertion on the effectiveness of Meridian Bioscience, Inc.s internal control over financial
reporting excluded internal control over financial reporting of the Bioline Group.
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.
- 42 -
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.
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 consolidated financial statements referred to above present fairly, in all
material respects, the financial position of Meridian Bioscience, Inc. as of September 30, 2010 and
2009, and the results of its operations and its cash flows for each of the three years in the
period ended September 30, 2010 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 aspects
internal control over financial reporting as of September 30, 2010, based on criteria established
in Internal ControlIntegrated Framework issued by COSO.
/s/ GRANT THORNTON LLP
Cincinnati, Ohio
November 29, 2010
- 43 -
CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share data)
Meridian
Bioscience, Inc. and Subsidiaries
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Year Ended September 30, |
|
2010 |
|
|
2009 |
|
|
2008 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Sales |
|
$ |
143,000 |
|
|
$ |
148,274 |
|
|
$ |
139,639 |
|
Cost of Sales |
|
|
54,525 |
|
|
|
55,491 |
|
|
|
53,159 |
|
|
|
|
|
|
|
|
|
|
|
Gross Profit |
|
|
88,475 |
|
|
|
92,783 |
|
|
|
86,480 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating Expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
8,570 |
|
|
|
8,428 |
|
|
|
6,183 |
|
Selling and marketing |
|
|
18,757 |
|
|
|
19,235 |
|
|
|
18,770 |
|
General and administrative |
|
|
18,770 |
|
|
|
16,341 |
|
|
|
17,177 |
|
Bioline Group transaction costs |
|
|
1,240 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
|
47,337 |
|
|
|
44,004 |
|
|
|
42,130 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating Income |
|
|
41,138 |
|
|
|
48,779 |
|
|
|
44,350 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other Income: |
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
124 |
|
|
|
456 |
|
|
|
1,533 |
|
Other, net |
|
|
138 |
|
|
|
88 |
|
|
|
109 |
|
|
|
|
|
|
|
|
|
|
|
Total other income |
|
|
262 |
|
|
|
544 |
|
|
|
1,642 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Earnings Before Income Taxes |
|
|
41,400 |
|
|
|
49,323 |
|
|
|
45,992 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income Tax Provision |
|
|
14,753 |
|
|
|
16,564 |
|
|
|
15,790 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Earnings |
|
$ |
26,647 |
|
|
$ |
32,759 |
|
|
$ |
30,202 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Earnings Per Share Data: |
|
|
|
|
|
|
|
|
|
|
|
|
Basic earnings per common share |
|
$ |
0.66 |
|
|
$ |
0.81 |
|
|
$ |
0.75 |
|
Diluted earnings per common share |
|
$ |
0.65 |
|
|
$ |
0.80 |
|
|
$ |
0.74 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common shares used for basic earnings
per common share |
|
|
40,515 |
|
|
|
40,390 |
|
|
|
40,093 |
|
Effect of dilutive stock options |
|
|
634 |
|
|
|
720 |
|
|
|
936 |
|
|
|
|
|
|
|
|
|
|
|
Common shares used for diluted earnings
per common share |
|
|
41,149 |
|
|
|
41,110 |
|
|
|
41,029 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dividends declared per common share |
|
$ |
0.74 |
|
|
$ |
0.65 |
|
|
$ |
0.53 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Anti-dilutive Securities: |
|
|
|
|
|
|
|
|
|
|
|
|
Common share options |
|
|
217 |
|
|
|
138 |
|
|
|
67 |
|
The accompanying notes are an integral part of these consolidated financial statements.
- 44 -
CONSOLIDATED STATEMENTS OF CASH FLOWS
(dollars in thousands)
Meridian Bioscience, Inc. and Subsidiaries
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Year Ended September 30, |
|
2010 |
|
|
2009 |
|
|
2008 |
|
Cash Flows From Operating Activities |
|
|
|
|
|
|
|
|
|
|
|
|
Net earnings |
|
$ |
26,647 |
|
|
$ |
32,759 |
|
|
$ |
30,202 |
|
Non-cash items: |
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation of property, plant and equipment |
|
|
3,104 |
|
|
|
2,781 |
|
|
|
2,857 |
|
Amortization of intangible assets |
|
|
1,581 |
|
|
|
1,579 |
|
|
|
1,612 |
|
Stock based compensation |
|
|
1,866 |
|
|
|
1,092 |
|
|
|
1,772 |
|
Deferred income taxes |
|
|
12 |
|
|
|
(500 |
) |
|
|
976 |
|
Loss on disposition of fixed assets |
|
|
26 |
|
|
|
109 |
|
|
|
9 |
|
Change in current assets, net of acquisition |
|
|
3,678 |
|
|
|
(5,353 |
) |
|
|
(5,147 |
) |
Change in current liabilities, net of acquisition |
|
|
(5,775 |
) |
|
|
269 |
|
|
|
(2,967 |
) |
Other, net |
|
|
74 |
|
|
|
(244 |
) |
|
|
569 |
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by operating activities |
|
|
31,213 |
|
|
|
32,492 |
|
|
|
29,883 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash Flows From Investing Activities |
|
|
|
|
|
|
|
|
|
|
|
|
Acquisition earnout payments |
|
|
|
|
|
|
(7 |
) |
|
|
(157 |
) |
Purchases of property, plant and equipment |
|
|
(4,563 |
) |
|
|
(3,643 |
) |
|
|
(4,219 |
) |
Proceeds from dispositions of property, plant and
equipment |
|
|
|
|
|
|
5 |
|
|
|
4 |
|
Purchases of investments |
|
|
|
|
|
|
|
|
|
|
(7,750 |
) |
Proceeds from sales and calls of short-term investments |
|
|
7,275 |
|
|
|
475 |
|
|
|
|
|
Acquisition of Bioline Group, net of cash received |
|
|
(20,404 |
) |
|
|
|
|
|
|
|
|
Purchases of intangibles and other assets |
|
|
(120 |
) |
|
|
(110 |
) |
|
|
(1,108 |
) |
|
|
|
|
|
|
|
|
|
|
Net cash used for investing activities |
|
|
(17,812 |
) |
|
|
(3,280 |
) |
|
|
(13,230 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash Flows From Financing Activities |
|
|
|
|
|
|
|
|
|
|
|
|
Dividends paid |
|
|
(29,985 |
) |
|
|
(26,260 |
) |
|
|
(21,256 |
) |
Proceeds and tax benefits from exercises of stock options |
|
|
795 |
|
|
|
1,624 |
|
|
|
4,563 |
|
|
|
|
|
|
|
|
|
|
|
Net cash used for financing activities |
|
|
(29,190 |
) |
|
|
(24,636 |
) |
|
|
(16,693 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Effect of Exchange Rate Changes on Cash and Equivalents |
|
|
(362 |
) |
|
|
157 |
|
|
|
(63 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Increase (Decrease) in Cash and Equivalents |
|
|
(16,151 |
) |
|
|
4,733 |
|
|
|
(103 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and Equivalents at Beginning of Period |
|
|
54,030 |
|
|
|
49,297 |
|
|
|
49,400 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and Equivalents at End of Period |
|
$ |
37,879 |
|
|
$ |
54,030 |
|
|
$ |
49,297 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental Cash Flow Information |
|
|
|
|
|
|
|
|
|
|
|
|
Cash paid for income taxes |
|
$ |
16,036 |
|
|
$ |
17,472 |
|
|
$ |
15,365 |
|
The accompanying notes are an integral part of these consolidated financial statements.
- 45 -
CONSOLIDATED BALANCE SHEETS
(dollars in thousands)
Meridian Bioscience, Inc. and Subsidiaries
|
|
|
|
|
|
|
|
|
As of September 30, |
|
2010 |
|
|
2009 |
|
Assets |
|
|
|
|
|
|
|
|
Current Assets: |
|
|
|
|
|
|
|
|
Cash and equivalents |
|
$ |
37,879 |
|
|
$ |
54,030 |
|
Investment in auction-rate securities and rights |
|
|
|
|
|
|
7,285 |
|
Accounts receivable, less allowances of $241 in 2010 and $247 in 2009 |
|
|
22,064 |
|
|
|
26,981 |
|
Inventories |
|
|
27,965 |
|
|
|
23,284 |
|
Prepaid expenses and other current assets |
|
|
4,277 |
|
|
|
3,632 |
|
Deferred income taxes |
|
|
1,835 |
|
|
|
1,935 |
|
|
|
|
|
|
|
|
Total current assets |
|
|
94,020 |
|
|
|
117,147 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Property, Plant and Equipment, at Cost: |
|
|
|
|
|
|
|
|
Land |
|
|
991 |
|
|
|
894 |
|
Buildings and improvements |
|
|
20,670 |
|
|
|
19,718 |
|
Machinery, equipment and furniture |
|
|
31,945 |
|
|
|
30,997 |
|
Construction in progress |
|
|
2,800 |
|
|
|
1,586 |
|
|
|
|
|
|
|
|
Subtotal |
|
|
56,406 |
|
|
|
53,195 |
|
Less: accumulated depreciation and amortization |
|
|
33,689 |
|
|
|
32,721 |
|
|
|
|
|
|
|
|
Net property, plant and equipment |
|
|
22,717 |
|
|
|
20,474 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other Assets: |
|
|
|
|
|
|
|
|
Goodwill |
|
|
23,482 |
|
|
|
9,866 |
|
Other intangible assets, net |
|
|
13,327 |
|
|
|
7,317 |
|
Restricted cash |
|
|
1,000 |
|
|
|
1,000 |
|
Other assets |
|
|
239 |
|
|
|
193 |
|
|
|
|
|
|
|
|
Total other assets |
|
|
38,048 |
|
|
|
18,376 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets |
|
$ |
154,785 |
|
|
$ |
155,997 |
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these consolidated financial statements.
- 46 -
CONSOLIDATED BALANCE SHEETS (dollars in thousands)
Meridian Bioscience, Inc. and Subsidiaries
|
|
|
|
|
|
|
|
|
As of September 30, |
|
2010 |
|
|
2009 |
|
Liabilities and Shareholders Equity |
|
|
|
|
|
|
|
|
Current Liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
4,466 |
|
|
$ |
6,901 |
|
Accrued employee compensation costs |
|
|
3,451 |
|
|
|
5,338 |
|
Other accrued expenses |
|
|
5,421 |
|
|
|
3,803 |
|
Income taxes payable |
|
|
809 |
|
|
|
710 |
|
|
|
|
|
|
|
|
Total current liabilities |
|
|
14,147 |
|
|
|
16,752 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deferred Income Taxes |
|
|
3,277 |
|
|
|
1,340 |
|
|
|
|
|
|
|
|
|
|
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, 40,654,286
and 40,493,313 issued |
|
|
|
|
|
|
|
|
Additional paid-in capital |
|
|
94,529 |
|
|
|
91,668 |
|
Retained earnings |
|
|
42,177 |
|
|
|
45,515 |
|
Accumulated other comprehensive income |
|
|
655 |
|
|
|
722 |
|
|
|
|
|
|
|
|
Total shareholders equity |
|
|
137,361 |
|
|
|
137,905 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities and shareholders equity |
|
$ |
154,785 |
|
|
$ |
155,997 |
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these consolidated financial statements.
- 47 -
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, 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 |
|
|
179 |
|
|
|
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 |
|
|
40,493 |
|
|
|
91,668 |
|
|
|
45,515 |
|
|
|
722 |
|
|
|
|
|
|
|
137,905 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash dividends paid $0.74 per share |
|
|
|
|
|
|
|
|
|
|
(29,985 |
) |
|
|
|
|
|
|
|
|
|
|
(29,985 |
) |
Exercise of stock options |
|
|
67 |
|
|
|
995 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
995 |
|
Issuance of restricted shares, net of
forfeitures |
|
|
94 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock compensation expense |
|
|
|
|
|
|
1,866 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,866 |
|
Comprehensive income: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net earnings |
|
|
|
|
|
|
|
|
|
|
26,647 |
|
|
|
|
|
|
$ |
26,647 |
|
|
|
26,647 |
|
Other comprehensive income taxes |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
36 |
|
|
|
36 |
|
|
|
36 |
|
Foreign currency translation adjustment |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(103 |
) |
|
|
(103 |
) |
|
|
(103 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
26,580 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at September 30, 2010 |
|
|
40,654 |
|
|
$ |
94,529 |
|
|
$ |
42,177 |
|
|
$ |
655 |
|
|
|
|
|
|
$ |
137,361 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these consolidated financial statements.
- 48 -
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 gastrointestinal, viral, respiratory and parasitic infectious diseases,
(ii) the manufacture and distribution of bulk antigens, antibodies, PCR/qPCR reagents,
nucleotides, competent cells and bioresearch reagents used by researchers and other diagnostic
manufacturers 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 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), 7 and 8
(b). |
(d) |
|
Foreign Currency Translation Assets and liabilities of foreign operations are translated
using year-end exchange rates with gains or losses resulting from translation included 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 Australian dollar, British pound and Euro currencies. These gains and losses are
included in other income and expense in the accompanying consolidated statements of
operations. |
- 49 -
(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 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
and institutional money market funds. At times our investments of cash and equivalents with
various high credit quality financial institutions may be in excess of the Federal Deposit
Insurance (FDIC) insurance limit. |
Our investment portfolio includes the following components:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30, 2010 |
|
|
September 30, 2009 |
|
|
|
Cash and |
|
|
|
|
|
|
Cash and |
|
|
|
|
|
|
Equivalents |
|
|
Other |
|
|
Equivalents |
|
|
Other |
|
Taxable investments - |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Repurchase agreements |
|
$ |
14,862 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
Money market funds |
|
|
10,249 |
|
|
|
|
|
|
|
29,032 |
|
|
|
|
|
|
|
Tax-exempt investments - |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Money market funds |
|
|
|
|
|
|
|
|
|
|
10,383 |
|
|
|
|
|
Student loan
auction-rate securities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
7,285 |
|
Cash on hand - |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Restricted |
|
|
|
|
|
|
1,000 |
|
|
|
|
|
|
|
1,000 |
|
Unrestricted |
|
|
12,768 |
|
|
|
|
|
|
|
14,615 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
37,879 |
|
|
$ |
1,000 |
|
|
$ |
54,030 |
|
|
$ |
8,285 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Our student loan auction-rate securities (SLARS) 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 permitted 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 was 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 received a payment of par
value upon the sale or disposition. In addition, the rights permitted 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 were still able to sell the auction-rate securities on our own, but in such a circumstance,
we would have lost 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 SLARS 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 the SLARS and Auction Rate Security Rights were recorded to
other income and expense in each accounting period. During May and June 2010, all of our SLARS
outstanding were either purchased by UBS, or put back to UBS via the Auction Rate Security
Rights. We received par value plus accrued interest on all of our SLARS. 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 Auction Rate Security Rights had a fair value of
$577 and, along with the SLARS, were included in current assets in the accompanying consolidated
balance sheet based on the earliest exercise date of June 30, 2010.
- 50 -
(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
$1,130 and $1,025 at September 30, 2010 and 2009, 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.
(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
Computer equipment and software 3 to 5 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 less cash and cash equivalents) 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 2010, 2009 or 2008. |
- 51 -
During fiscal 2010, the change in goodwill was an increase of $13,616. This change resulted
solely from the July 2010 acquisition of the Bioline Group (Life Science operating segment).
See Note 2. During fiscal 2009, the change in goodwill was an increase of $5. This change
consisted of an increase related to the OEM Concepts earnout obligation for calendar 2008 (Life
Science operating segment).
A summary of Meridians acquired intangible assets subject to amortization, as of September 30,
2010 and 2009 is as follows.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Wtd Avg |
|
|
2010 |
|
|
2009 |
|
|
|
Amort |
|
|
Gross |
|
|
|
|
|
|
Gross |
|
|
|
|
|
|
Period |
|
|
Carrying |
|
|
Accum. |
|
|
Carrying |
|
|
Accum. |
|
As of September 30, |
|
(Yrs) |
|
|
Value |
|
|
Amort. |
|
|
Value |
|
|
Amort. |
|
Manufacturing technologies, core
products and cell lines |
|
|
13 |
|
|
$ |
11,644 |
|
|
$ |
7,693 |
|
|
$ |
10,755 |
|
|
$ |
7,672 |
|
Trademarks, licenses and patents |
|
|
10 |
|
|
|
3,547 |
|
|
|
997 |
|
|
|
2,772 |
|
|
|
1,974 |
|
Customer lists and supply
agreements |
|
|
11 |
|
|
|
12,537 |
|
|
|
5,816 |
|
|
|
11,040 |
|
|
|
7,604 |
|
Non-compete agreements |
|
|
1 |
|
|
|
126 |
|
|
|
21 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
27,854 |
|
|
$ |
14,527 |
|
|
$ |
24,567 |
|
|
$ |
17,250 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The actual aggregate amortization expense for these intangible assets for fiscal 2010, 2009 and
2008 was $1,581, $1,579 and $1,612, respectively. The estimated aggregate amortization expense
for these intangible assets for each of the five succeeding fiscal years is as follows: fiscal
2011 $2,304, fiscal 2012 $2,059, fiscal 2013 $2,058, fiscal 2014 $1,630 and fiscal 2015
$1,374.
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.
- 52 -
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 U.S. 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 data provided by these customers, estimates
of inventories of our products held by these customers, historical statistics, current trends,
and other factors. Changes to the accruals are recorded in the period that they become known.
Our rebate accruals were $5,273 at September 30, 2010 and $4,776 at September 30, 2009. |
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 customer pricing. Pricing is often subject to 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 sheets 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.
- 53 -
(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. |
We account for uncertain tax positions using a benefit recognition model with a two-step
approach: (i) a more-likely-than-not recognition criterion; and (ii) a measurement attribute
that measures the position as the largest amount of tax benefit that is greater than 50% likely
of being ultimately realized upon ultimate settlement. If it is not more likely than not that
the benefit will be sustained on its technical merits, no benefit is recorded. We recognize
accrued interest related to unrecognized tax benefits as a portion of our income tax provision
in the consolidated statements of operations. See Note 7.
(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 and
restricted stock awards granted after July 1, 2005, and the non-vested portions of stock
option awards granted prior to July 1, 2005. See Note 8(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,
and the related income tax effects. Components of beginning and ending accumulated other
comprehensive income or loss, and related activity, are shown in the following table: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign |
|
|
|
|
|
|
|
|
|
Currency |
|
|
|
|
|
|
|
|
|
Translation |
|
|
Income |
|
|
|
|
|
|
Adjustment |
|
|
Taxes |
|
|
Total |
|
Balance at September 30, 2009 |
|
$ |
1,110 |
|
|
$ |
(388 |
) |
|
$ |
722 |
|
|
|
|
|
|
|
|
|
|
|
Currency translation |
|
|
(103 |
) |
|
|
|
|
|
|
(103 |
) |
Income taxes |
|
|
|
|
|
|
36 |
|
|
|
36 |
|
|
|
|
|
|
|
|
|
|
|
Balance at September 30, 2010 |
|
$ |
1,007 |
|
|
$ |
(352 |
) |
|
$ |
655 |
|
|
|
|
|
|
|
|
|
|
|
- 54 -
(n) |
|
Recent Accounting Pronouncements In February 2010, the Financial Accounting Standards Board
issued ASU 2010-06, Fair Value Measurements and Disclosures (Topic 820): Improving
Disclosures about Fair Value Measurements. This ASU amends the disclosure requirements
related to Fair Value Measurements and Disclosures Overall Subtopic (Subtopic 820-10) of the
FASB Accounting Standards Codification, originally issued as FASB Statement No. 157, Fair
Value Measurements. The intent of the amended guidance is improved disclosure and increased
transparency related to Fair Value Measurement in financial reporting. This amended guidance
is effective for interim and annual periods beginning after December 15, 2009, except for the
disaggregation requirement for the reconciliation disclosure of Level 3 measurements, which is
effective for fiscal years beginning after December 15, 2010 and for interim periods within
those years. We partially adopted the new guidance during the three months ended March 31,
2010 and there was no impact on our consolidated results of operations, cash flows or
financial position. |
(o) |
|
Shipping and Handling Costs Shipping and handling costs invoiced to customers are included
in net sales. Costs to distribute products to customers, including freight costs, warehousing
costs, and other shipping and handling activities are included in cost of goods sold. |
(p) |
|
Non-income Government-Assessed Taxes We classify all non-income, government-assessed taxes
(sales, use, and value-added) collected from customers and remitted by us to appropriate
revenue authorities, on a net basis (excluded from net sales) in the accompanying consolidated
statements of operations. |
(2) Acquisition of Bioline Group
On July 20, 2010, we acquired all of the outstanding common stock of the Bioline group of companies
(collectively the Bioline Group). We paid $23,849 to acquire the Bioline Group from cash and
equivalents on hand. Headquartered in London, the Bioline Group is a leading manufacturer and
distributor of molecular biology reagents with additional operations in Germany, Australia and the
United States. The highly specialized molecular biology reagents it supplies to the life science
research, biotech, pharmaceutical and commercial diagnostics markets are the critical components
used in PCR testing for DNA, RNA and other genomic testing.
- 55 -
As a result of the consideration paid exceeding the fair value of the net assets being acquired,
goodwill in the amount of $13,166 was recorded in connection with this acquisition, none of which
will be deductible for tax purposes. This goodwill results largely from the addition of key global
operations and direct sales capabilities, management talent and a research-oriented customer base,
to complement our existing Life Science operations. In addition to the Bioline Groups results of
operations since the acquisition date, which are included in our fiscal 2010 Consolidated Statement
of Operations and reported as part of the Life Science operating segment, the fiscal 2010
consolidated results also include:
|
i) |
|
$230 of Cost of Sales related to the roll-out of fair value inventory
adjustments for sales of products that were in the Bioline Groups inventory on the
date of acquisition and, therefore, were valued at fair value, rather than manufactured
cost, in the opening balance sheet; |
|
ii) |
|
$166 of General and Administrative Expenses related to the amortization of
specific identifiable intangible assets recorded on the opening balance sheet,
including customer relationships, license agreements, non-compete agreements,
manufacturing processes and trade names; and |
|
|
iii) |
|
$1,240 of transaction costs reflected as Operating Expenses. |
The results of the Bioline Group included in the fiscal 2010 consolidated results of the Company
are Net Sales of $2,084 and Net Loss of $1,262, reflecting the items noted above.
The recognized amounts of identifiable assets acquired and liabilities assumed in the acquisition
of the Bioline Group are as follows:
|
|
|
|
|
Fair value of assets acquired - |
|
|
|
|
Cash and equivalents |
|
$ |
3,445 |
|
Accounts receivable |
|
|
1,897 |
|
Inventories |
|
|
2,807 |
|
Other current assets |
|
|
371 |
|
Property, plant and equipment, net |
|
|
816 |
|
Goodwill |
|
|
13,166 |
|
Other intangible assets (estimated useful life): |
|
|
|
|
Customer relationships (10 years) |
|
|
3,898 |
|
Manufacturing processes (6 years) |
|
|
1,467 |
|
License agreements (approximate
8 year weighted average) |
|
|
718 |
|
Non-compete agreements (1 year) |
|
|
122 |
|
Trade names (10 years) |
|
|
995 |
|
|
|
|
|
|
|
|
29,702 |
|
Fair value of liabilities assumed - |
|
|
|
|
Accounts payable and accrued expenses |
|
|
2,817 |
|
Deferred income tax liabilities |
|
|
3,036 |
|
|
|
|
|
Total consideration paid |
|
$ |
23,849 |
|
|
|
|
|
The allocation of the purchase price shown above is preliminary, pending final completion of
valuation of acquired intangibles and tax assets and liabilities.
- 56 -
The consolidated pro forma results of the combined entities of Meridian and the Bioline Group, had
the acquisition date been October 1, 2007, are as follows for the periods indicated:
|
|
|
|
|
|
|
|
|
|
|
(UNAUDITED) |
|
|
|
Net |
|
|
Net |
|
|
|
Sales |
|
|
Earnings |
|
Consolidated pro forma fiscal 2010 |
|
$ |
153,635 |
|
|
$ |
26,918 |
|
Consolidated pro forma fiscal 2009 |
|
$ |
160,525 |
|
|
$ |
34,135 |
|
Consolidated pro forma fiscal 2008 |
|
$ |
151,424 |
|
|
$ |
31,214 |
|
The fiscal 2010 consolidated pro forma results listed above include pre-tax acquisition-related
expenses totaling $1,636 for the fair value inventory adjustment, the amortization of identifiable
intangibles and transaction costs. Fiscal 2009 and 2008 reflect no such pre-tax expenses. These
pre-tax expenses are included in the as-reported consolidated fiscal 2010 results.
(3) Inventories
Inventories are comprised of the following:
|
|
|
|
|
|
|
|
|
As of September 30, |
|
2010 |
|
|
2009 |
|
Raw materials |
|
$ |
6,221 |
|
|
$ |
6,079 |
|
Work-in-process |
|
|
6,784 |
|
|
|
5,916 |
|
Finished goods |
|
|
16,090 |
|
|
|
12,314 |
|
|
|
|
|
|
|
|
Gross Inventory |
|
$ |
29,095 |
|
|
$ |
24,309 |
|
|
|
|
|
|
|
|
Reserves |
|
|
(1,130 |
) |
|
|
(1,025 |
) |
|
|
|
|
|
|
|
Net Inventory |
|
$ |
27,965 |
|
|
$ |
23,284 |
|
|
|
|
|
|
|
|
(4) 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-U.S.
subsidiaries, which totaled approximately $107,000 at September 30, 2010. There were no borrowings
outstanding on this credit facility at September 30, 2010 or September 30, 2009. Available
borrowings under this credit facility were $30,000 at September 30, 2010 and September 30, 2009.
In connection with this bank credit facility, we are required to comply with financial covenants
that limit the amount of debt obligations and require a minimum amount of tangible net worth. 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 facility and are in compliance
with this requirement.
(5) 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, 2010 and September 30, 2009, we had no such contracts outstanding.
- 57 -
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.
The amount of gain (loss) recognized in other comprehensive income on the effective portion of our
foreign exchange contracts was $0, $109 and $(326) in fiscal 2010, 2009 and 2008, respectively.
The amount of gain (loss) reclassified from accumulated other comprehensive income into income on
the effective portion of these foreign exchange contracts was $0, $112 and $(599), for fiscal 2010,
2009 and 2008, respectively. No portion of the gain/loss was excluded from other comprehensive
income due to effectiveness testing.
(6) Fair Value Measurements
We use a fair value measurement 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 our 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.
- 58 -
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 considers counterparty credit risk in the assessment
of fair value.
Financial assets and liabilities carried at fair value at September 30, 2010 and September 30, 2009
are classified in the table below in one of the three categories described above:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balances as of September 30, 2010 |
|
Level 1 |
|
|
Level 2 |
|
|
Level 3 |
|
|
Total |
|
Money market funds |
|
$ |
10,249 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
10,249 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
10,249 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
10,249 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balances as of September 30, 2009 |
|
Level 1 |
|
|
Level 2 |
|
|
Level 3 |
|
|
Total |
|
Money market funds |
|
$ |
39,415 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
39,415 |
|
Student loan auction-rate securities |
|
|
|
|
|
|
|
|
|
|
6,708 |
|
|
|
6,708 |
|
UBS Auction Rate Security Rights |
|
|
|
|
|
|
|
|
|
|
577 |
|
|
|
577 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
39,415 |
|
|
$ |
|
|
|
$ |
7,285 |
|
|
$ |
46,700 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Prior to their liquidation at par value plus accrued interest in May and June 2010, 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 required the use of a valuation
methodology that relied primarily 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 was subject to
uncertainties that were difficult to predict. Factors that could impact the valuations included
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 changes in
fair value of our auction-rate securities and UBS Auction Rate Security Rights for the fiscal years
ended September 30, 2010 and September 30, 2009 were ($10) and ($195), respectively.
- 59 -
(7) Income Taxes
(a) |
|
Earnings before income taxes, and the related provision for income taxes for the years ended
September 30, 2010, 2009 and 2008 were as follows: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended September 30, |
|
2010 |
|
|
2009 |
|
|
2008 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Domestic |
|
$ |
38,329 |
|
|
$ |
46,504 |
|
|
$ |
42,187 |
|
Foreign |
|
|
3,071 |
|
|
|
2,819 |
|
|
|
3,805 |
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
41,400 |
|
|
$ |
49,323 |
|
|
$ |
45,992 |
|
|
|
|
|
|
|
|
|
|
|
Provision (credit) for income taxes - |
|
|
|
|
|
|
|
|
|
|
|
|
Federal - |
|
|
|
|
|
|
|
|
|
|
|
|
Current provision |
|
$ |
13,626 |
|
|
$ |
15,094 |
|
|
$ |
14,307 |
|
Temporary differences |
|
|
|
|
|
|
|
|
|
|
|
|
Fixed asset basis differences and depreciation |
|
|
58 |
|
|
|
16 |
|
|
|
(108 |
) |
Intangible asset basis differences and amortization |
|
|
(335 |
) |
|
|
(363 |
) |
|
|
(249 |
) |
Currently non-deductible expenses and reserves |
|
|
(29 |
) |
|
|
(134 |
) |
|
|
(286 |
) |
Stock based compensation |
|
|
(618 |
) |
|
|
(373 |
) |
|
|
(610 |
) |
Other, net |
|
|
(75 |
) |
|
|
48 |
|
|
|
231 |
|
|
|
|
|
|
|
|
|
|
|
Subtotal |
|
|
12,627 |
|
|
|
14,288 |
|
|
|
13,285 |
|
State and local |
|
|
1,186 |
|
|
|
1,385 |
|
|
|
1,303 |
|
Foreign |
|
|
940 |
|
|
|
891 |
|
|
|
1,202 |
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
14,753 |
|
|
$ |
16,564 |
|
|
$ |
15,790 |
|
|
|
|
|
|
|
|
|
|
|
(b) |
|
The following is a reconciliation between the statutory U.S. income tax rate and the
effective rate derived by dividing the provision for income taxes by earnings before income
taxes: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended September 30, |
|
2010 |
|
|
2009 |
|
|
2008 |
|
Computed income taxes at statutory rate |
|
$ |
14,490 |
|
|
|
35.0 |
% |
|
$ |
17,263 |
|
|
|
35.0 |
% |
|
$ |
16,097 |
|
|
|
35.0 |
% |
Increase (decrease) in taxes resulting from - |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
State and local income taxes |
|
|
777 |
|
|
|
1.9 |
|
|
|
904 |
|
|
|
1.8 |
|
|
|
902 |
|
|
|
2.0 |
|
Federal and state tax credits |
|
|
|
|
|
|
|
|
|
|
(189 |
) |
|
|
(0.4 |
) |
|
|
(34 |
) |
|
|
(0.1 |
) |
Foreign tax rate differences |
|
|
(87 |
) |
|
|
(0.2 |
) |
|
|
(43 |
) |
|
|
(0.1 |
) |
|
|
196 |
|
|
|
0.4 |
|
Qualified domestic production
incentives |
|
|
(786 |
) |
|
|
(1.9 |
) |
|
|
(870 |
) |
|
|
(1.8 |
) |
|
|
(715 |
) |
|
|
(1.6 |
) |
Tax exempt interest |
|
|
(12 |
) |
|
|
|
|
|
|
(100 |
) |
|
|
(0.2 |
) |
|
|
(417 |
) |
|
|
(0.9 |
) |
Bioline Group transaction costs |
|
|
434 |
|
|
|
1.0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other, net |
|
|
(63 |
) |
|
|
(0.2 |
) |
|
|
(401 |
) |
|
|
(0.7 |
) |
|
|
(239 |
) |
|
|
(0.5 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
14,753 |
|
|
|
35.6 |
% |
|
$ |
16,564 |
|
|
|
33.6 |
% |
|
$ |
15,790 |
|
|
|
34.3 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
- 60 -
(c) |
|
The components of net deferred tax assets (liabilities) were as follows: |
|
|
|
|
|
|
|
|
|
As of September 30, |
|
2010 |
|
|
2009 |
|
Deferred tax assets - |
|
|
|
|
|
|
|
|
Valuation reserves and non-deductible expenses |
|
$ |
1,128 |
|
|
$ |
1,043 |
|
Stock compensation expense not deductible |
|
|
2,313 |
|
|
|
1,762 |
|
Net operating loss carryforwards |
|
|
740 |
|
|
|
948 |
|
Inventory basis differences |
|
|
589 |
|
|
|
886 |
|
Other |
|
|
118 |
|
|
|
6 |
|
|
|
|
|
|
|
|
Subtotal |
|
|
4,888 |
|
|
|
4,645 |
|
Less valuation allowance |
|
|
(439 |
) |
|
|
(470 |
) |
|
|
|
|
|
|
|
Deferred tax assets |
|
|
4,449 |
|
|
|
4,175 |
|
|
|
|
|
|
|
|
Deferred tax liabilities - |
|
|
|
|
|
|
|
|
Fixed asset basis differences and depreciation |
|
|
(721 |
) |
|
|
(656 |
) |
Intangible asset basis differences and amortization |
|
|
(4,591 |
) |
|
|
(2,263 |
) |
Other |
|
|
(579 |
) |
|
|
(661 |
) |
|
|
|
|
|
|
|
Deferred tax liabilities |
|
|
(5,891 |
) |
|
|
(3,580 |
) |
|
|
|
|
|
|
|
Net deferred tax assets (liabilities) |
|
$ |
(1,442 |
) |
|
$ |
595 |
|
|
|
|
|
|
|
|
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 totaling $740 and $948 at September
30, 2010 and September 30, 2009, respectively, inclusive of valuation allowances for the country of
Belgium. 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, 2010 and September 30, 2009 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 reinvested indefinitely in the Italian operation were approximately $18,900
at September 30, 2010. U.S. deferred tax liabilities of approximately $6,995 on such earnings have
not been recorded. We believe that such U.S. taxes would be largely offset by foreign tax credits
for taxes paid in Italy.
- 61 -
As described in Note 1, we utilize a comprehensive model for the recognition, measurement,
presentation and disclosure of uncertain tax positions, assuming full knowledge of all relevant
facts by the applicable tax
authorities. The total amount of unrecognized tax benefits at September 30, 2010 and September 30,
2009 related to such positions was $725 and $572, 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 2010 and
2009, we increased/(decreased) our tax provision by approximately $128 and ($45), respectively, for
such interest and penalties. We had approximately $229 accrued for the payment of interest and
penalties at September 30, 2010 compared to $102 accrued at September 30, 2009. 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:
|
|
|
|
|
|
|
|
|
|
|
2010 |
|
|
2009 |
|
Unrecognized income tax benefits beginning of year |
|
$ |
572 |
|
|
$ |
779 |
|
Additions for tax positions related to the current year |
|
|
67 |
|
|
|
115 |
|
Additions for tax positions of prior years |
|
|
206 |
|
|
|
109 |
|
Reductions for tax positions of prior years |
|
|
|
|
|
|
(287 |
) |
Expirations of statute of limitations |
|
|
(120 |
) |
|
|
(144 |
) |
|
|
|
|
|
|
|
Unrecognized income tax benefits at end of year |
|
$ |
725 |
|
|
$ |
572 |
|
|
|
|
|
|
|
|
We are subject to examination by the tax authorities in the U.S. (both federal and state) and the
countries of Australia, Belgium, England, France, Germany, Holland and Italy. In the U.S., open
tax years are for fiscal 2007 and forward. Our federal returns for fiscal 2008 and 2009 are
currently under examination by the IRS. In countries outside the U.S., open tax years generally
range from fiscal 2005 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.
(8) Employee Benefits
(a) |
|
Savings and Investment Plan We have a profit sharing and retirement savings plan covering
substantially all full-time U.S. employees. Profit sharing contributions to the plan, which
are discretionary, are approved by the Board of Directors. The plan permits participants to
contribute to the plan through salary reduction. Under terms of the plan, we match 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 $1,282, $1,188
and $1,214, during fiscal 2010, 2009 and 2008, respectively. |
(b) |
|
Stock-Based Compensation Plans We have one active stock-based compensation plan, the 2004
Equity Compensation plan, which became effective December 7, 2004, as amended (the 2004
Plan) and an Employee Stock Purchase Plan (the ESP Plan), which became effective October 1,
1997. Effective October 1, 1997, we began selling shares of stock to our full-time and
part-time employees under the ESP
Plan up to the number of shares equivalent to a 1% to 15% payroll deduction from an employees
base salary plus an additional 5% dollar match of this deduction by Meridian. |
- 62 -
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 1,710 through September 30, 2010. 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. Similarly, on November 12,
2009, we granted approximately 105 restricted shares and restricted units to certain employees,
with half of each employees grant being time-vested restricted shares or restricted units
vesting in total on November 12, 2013, and the remaining half being subject to attainment of a
specified earnings target for fiscal 2010. Dividends were paid on these shares throughout
fiscal 2010. While the 2010 earnings target was not met, on September 30, 2010, the
Compensation Committee of the Board of Directors chose to convert the performance-based
restricted shares to time-vested restricted shares vesting in total on November 12, 2013 in
recognition of the achievement in 2010 of several strategic initiatives that position the
Company for future growth. This conversion impacted approximately fifty employees and resulted
in expense totaling $472, which was recorded in fiscal 2010 and is included in the total amount
of stock-based compensation set forth below. During fiscal 2010, approximately 2 of the
restricted shares were forfeited, resulting in approximately 103 restricted shares and units
outstanding as of September 30, 2010, with a weighted average remaining vesting period of 3.125
years.
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 and restricted stock 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 $1,866, $1,092 and $1,772 in fiscal
2010, 2009 and 2008, respectively. The fiscal 2010 expense is comprised of $908 related to
stock options and $958 related to restricted shares and units. The total income tax benefit
recognized in the income statement
for these stock-based compensation arrangements was $665, $367 and $610, for fiscal 2010, 2009
and 2008, respectively. As of September 30, 2010, we expect future stock compensation expense
for unvested options and unvested restricted stock to total $655 and $1,331, respectively, which
will be recognized during fiscal years 2011 through 2014.
- 63 -
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 2010, 2009 and 2008, we recorded $17, $42 and $235, respectively, in stock
compensation expense to adjust estimated forfeiture rates to actual.
We have elected to use the Black-Scholes option pricing model to determine grant-date fair value
for stock options, with the following assumptions: (i) expected share price volatility based on
average of Meridians historical volatility over twelve months and implied volatility based on
the value of tradable call options; (ii) expected life of options based on contractual lives,
employees historical exercise behavior and employees historical post-vesting employment
termination behavior; (iii) risk-free interest rates based on treasury rates that correspond to
the expected lives of the options; and (iv) dividend yield based on the expected yield on
underlying Meridian common stock.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2010 |
|
|
2009 |
|
|
2008 |
|
Year ended September 30, |
|
|
|
|
|
|
|
|
|
|
|
|
Risk-free interest rates |
|
|
2.93 |
% |
|
|
3.75 |
% |
|
|
4.56 |
% |
Dividend yield |
|
|
3.12 |
% |
|
|
2.41 |
% |
|
|
1.45 |
% |
Life of option |
|
5.90 yrs. |
|
6.30-8.20 yrs. |
|
|
5.70-7.30 yrs. |
|
Share price volatility |
|
|
42 |
% |
|
|
57 |
% |
|
|
44 |
% |
Forfeitures (by
employee group) |
|
|
0%-10 |
% |
|
|
0%-13 |
% |
|
|
0%-17 |
% |
A summary of the status of our stock option plans at September 30, 2010 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 |
|
|
1,401 |
|
|
$ |
10.69 |
|
|
|
|
|
|
|
|
|
Grants |
|
|
99 |
|
|
|
20.84 |
|
|
|
|
|
|
|
|
|
Exercises |
|
|
(67 |
) |
|
|
8.79 |
|
|
|
|
|
|
|
|
|
Forfeitures |
|
|
(6 |
) |
|
|
19.72 |
|
|
|
|
|
|
|
|
|
Cancellations |
|
|
(2 |
) |
|
|
13.82 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding end of period |
|
|
1,425 |
|
|
$ |
11.44 |
|
|
|
4.3241 |
|
|
$ |
16,053 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercisable end of period |
|
|
786 |
|
|
$ |
12.96 |
|
|
|
5.0342 |
|
|
$ |
7,489 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
- 64 -
A summary of the status of our nonvested shares as of September 30, 2010, and changes during
the year ended September 30, 2010, is presented below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted- |
|
|
|
|
|
|
|
Average |
|
|
|
|
|
|
|
Grant Date |
|
|
|
Shares |
|
|
Fair Value |
|
Nonvested beginning of period |
|
|
753 |
|
|
$ |
4.44 |
|
Granted |
|
|
99 |
|
|
|
6.70 |
|
Vested |
|
|
(207 |
) |
|
|
7.52 |
|
Forfeited |
|
|
(6 |
) |
|
|
8.45 |
|
|
|
|
|
|
|
|
Nonvested end of period |
|
|
639 |
|
|
$ |
3.75 |
|
|
|
|
|
|
|
|
The weighted average grant-date fair value of options granted was $6.70, $11.05 and $14.58 for
fiscal 2010, 2009 and 2008, respectively. The total intrinsic value of options exercised was
$813, $2,560 and $11,405, for fiscal 2010, 2009 and 2008, respectively. The total grant-date
fair value of options that vested during fiscal 2010, 2009 and 2008 was $1,558, $2,019 and
$1,674, respectively.
Cash received from options exercised was $592, $1,243 and $2,668 for fiscal 2010, 2009 and 2008,
respectively. Tax benefits realized and recorded to additional paid-in capital from option
exercises totaled $403, $233 and $2,458 for fiscal 2010, 2009 and 2008, respectively.
(9) Major Customers and Segment Data
Our reportable operating segments are U.S. Diagnostics, European Diagnostics and Life Science. The
U.S. Diagnostics operating segment consists of manufacturing operations in Cincinnati, Ohio, and
the sale and distribution of diagnostic test kits in the U.S. 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; Boca
Raton, Florida; London, England; Luckenwalde, Germany; and Sydney, Australia, and the sale and
distribution of bulk antigens, antibodies, PCR/qPCR reagents, nucleotides, competent cells and
bioresearch reagents domestically and abroad. 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.
- 65 -
Sales to individual customers constituting 10% or more of consolidated net sales were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended September 30, |
|
2010 |
|
|
2009 |
|
|
2008 |
|
Customer A |
|
$ |
33,821 |
|
|
|
(24 |
)% |
|
$ |
37,876 |
|
|
|
(26 |
)% |
|
$ |
31,285 |
|
|
|
(22 |
)% |
Customer B |
|
$ |
18,204 |
|
|
|
(13 |
)% |
|
$ |
19,063 |
|
|
|
(13 |
)% |
|
$ |
16,160 |
|
|
|
(12 |
)% |
Combined international sales for the U.S. Diagnostics and Life Science operating segments were
$19,350, $15,568 and $16,450 in fiscal years 2010, 2009 and 2008, respectively. Three products
accounted for 28%, 30% and 32% of consolidated net sales in fiscal 2010, 2009 and 2008,
respectively. Approximately 27% of the consolidated accounts receivable balance at September 30,
2010 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, |
|
2010 |
|
|
2009 |
|
|
2008 |
|
Italy |
|
$ |
8,183 |
|
|
$ |
8,289 |
|
|
$ |
8,942 |
|
United Kingdom |
|
|
2,646 |
|
|
|
2,373 |
|
|
|
2,655 |
|
France |
|
|
2,590 |
|
|
|
2,939 |
|
|
|
3,263 |
|
Holland |
|
|
2,045 |
|
|
|
1,828 |
|
|
|
2,138 |
|
Belgium |
|
|
1,291 |
|
|
|
1,875 |
|
|
|
1,865 |
|
Other countries |
|
|
7,286 |
|
|
|
8,566 |
|
|
|
9,117 |
|
|
|
|
|
|
|
|
|
|
|
Total European Diagnostics |
|
$ |
24,041 |
|
|
$ |
25,870 |
|
|
$ |
27,980 |
|
|
|
|
|
|
|
|
|
|
|
Identifiable assets for our Italian distribution organization were $17,378, $16,797 and $14,769 at
September 30, 2010, 2009 and 2008, respectively. At September 30, 2010, identifiable assets for
the Bioline Groups operations in the U.K., Germany and Australia totaled $16,990, $4,441 and
$3,094, respectively.
- 66 -
Segment information for the years ended September 30, 2010, 2009 and 2008 is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. |
|
|
European |
|
|
|
|
|
|
|
|
|
|
Fiscal Year 2010 - |
|
Diagnostics |
|
|
Diagnostics |
|
|
Life Science |
|
|
Elim (1) |
|
|
Total |
|
Net sales - |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Third-party |
|
$ |
92,020 |
|
|
$ |
24,041 |
|
|
$ |
26,939 |
|
|
$ |
|
|
|
$ |
143,000 |
|
Inter-segment |
|
|
10,285 |
|
|
|
20 |
|
|
|
561 |
|
|
|
(10,866 |
) |
|
|
|
|
Operating income |
|
|
33,432 |
|
|
|
3,367 |
|
|
|
3,615 |
|
|
|
724 |
|
|
|
41,138 |
|
Depreciation and amortization |
|
|
2,722 |
|
|
|
86 |
|
|
|
1,877 |
|
|
|
|
|
|
|
4,685 |
|
Capital expenditures |
|
|
3,349 |
|
|
|
213 |
|
|
|
1,001 |
|
|
|
|
|
|
|
4,563 |
|
Total assets |
|
|
125,824 |
|
|
|
35,834 |
|
|
|
90,532 |
|
|
|
(97,405 |
) |
|
|
154,785 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
Eliminations consist of intersegment transactions. |
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended September 30, |
|
2010 |
|
|
2009 |
|
|
2008 |
|
Segment operating income |
|
$ |
41,138 |
|
|
$ |
48,779 |
|
|
$ |
44,350 |
|
Interest income |
|
|
124 |
|
|
|
456 |
|
|
|
1,533 |
|
Other, net |
|
|
138 |
|
|
|
88 |
|
|
|
109 |
|
|
|
|
|
|
|
|
|
|
|
Consolidated earnings before
income taxes |
|
$ |
41,400 |
|
|
$ |
49,323 |
|
|
$ |
45,992 |
|
|
|
|
|
|
|
|
|
|
|
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 U.S. Diagnostics and Life Science
operating segments include goodwill of $1,381 and $22,101, respectively at September 30, 2010,
$1,381 and $8,485, respectively at September 30, 2009, and $1,382 and $8,479, respectively at
September 30, 2008.
- 67 -
(10) Commitments and Contingencies
(a) |
|
Royalty Commitments We have entered into various license agreements that require payment of
royalties based on a specified percentage of the sales of licensed products (1% to 14%).
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 $734, $572 and $600, respectively, for the fiscal years ended September 30,
2010, 2009 and 2008. |
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 remaining
payments of up to approximately $3,200 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.
Since entering into this agreement, we have made payments totaling $392.
(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
$13,004, $277 and $94 for fiscal 2011, 2012 and 2013, respectively. No commitments have been
made beyond fiscal 2013. |
(c) |
|
Operating Lease Commitments Meridian and its subsidiaries are lessees of (i) certain office
and warehouse buildings in the U.S., Europe and Australia; (ii) automobiles for use by the
direct sales forces in the U.S. and Europe; and (iii) certain office equipment such as
facsimile and copier machines across all business units, under operating lease agreements that
expire at various dates. Amounts charged to expense under operating leases were $759, $775
and $674 for fiscal 2010, 2009 and 2008, respectively. Operating lease commitments for each
of the five succeeding fiscal years are as follows: fiscal 2011 $935, fiscal 2012 $763,
fiscal 2013 $479, fiscal 2014 $154, and fiscal 2015 $54. |
(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. |
(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, 2010 or September 30, 2009. 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. |
- 68 -
(11) 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 2010 |
|
December 31 |
|
|
March 31 |
|
|
June 30 |
|
|
September 30 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net sales |
|
$ |
42,457 |
|
|
$ |
31,147 |
|
|
$ |
33,857 |
|
|
$ |
35,539 |
|
Gross profit |
|
|
25,485 |
|
|
|
20,167 |
|
|
|
21,736 |
|
|
|
21,087 |
|
Net earnings |
|
|
8,921 |
|
|
|
5,980 |
|
|
|
6,424 |
|
|
|
5,322 |
|
Basic earnings per common share |
|
|
0.22 |
|
|
|
0.15 |
|
|
|
0.16 |
|
|
|
0.13 |
|
Diluted earnings per common share |
|
|
0.22 |
|
|
|
0.15 |
|
|
|
0.16 |
|
|
|
0.13 |
|
Cash dividends per common share |
|
|
0.17 |
|
|
|
0.19 |
|
|
|
0.19 |
|
|
|
0.19 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 |
|
(12) Subsequent Events
We evaluated subsequent events after the balance sheet date of September 30, 2010 and there were no
material subsequent events that required recognition or additional disclosure in these statements.
ITEM 9.
CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS
ON ACCOUNTING AND FINANCIAL DISCLOSURE
Not applicable.
ITEM 9A.
CONTROLS AND PROCEDURES
As of September 30, 2010, 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, 2010. 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, 2010.
- 69 -
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.
- 70 -
PART III
The information required by Items 10., 11., 12. (other than that portion set forth below), 13. and 14., of Part III are incorporated by reference
from the Registrants Proxy Statement for its 2011 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, 2010 with respect to all of
our equity compensation plans.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(c) |
|
|
|
(a) |
|
|
(b) |
|
|
Number of securities |
|
|
|
Number of |
|
|
Weighted- |
|
|
remaining available |
|
|
|
Securities to be |
|
|
average exercise |
|
|
for future issuance |
|
|
|
issued upon |
|
|
price of |
|
|
under equity |
|
|
|
exercise of |
|
|
outstanding |
|
|
compensation plans |
|
|
|
outstanding |
|
|
options, |
|
|
(excluding securities |
|
|
|
options, warrants |
|
|
warrants and |
|
|
reflected in column |
|
Plan Category |
|
and rights |
|
|
rights |
|
|
(a)) |
|
Equity compensation
plans approved by
security holders
(1) |
|
|
1,521 |
|
|
$ |
10.637 |
|
|
|
1,757 |
|
Equity compensation plans not approved
by security holders |
|
|
7 |
|
|
|
18.976 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
1,528 |
|
|
$ |
10.673 |
|
|
|
1,757 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(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 |
- 71 -
ITEM 15.
EXHIBITS, FINANCIAL STATEMENT SCHEDULES
(a) (1) and (2) FINANCIAL STATEMENTS AND SCHEDULES.
All financial statements and schedules required to be filed by Item 8 of this Form and included in
this report have been listed previously under Item 8. No additional financial statements or
schedules are being filed since the requirements of paragraph (c) under Item 15 are not applicable
to Meridian.
(b) (3) EXHIBITS.
|
|
|
|
|
Exhibit Number |
|
Description of Exhibit |
|
|
|
|
|
|
3.1 |
|
|
Articles of Incorporation, including amendments not related
to Company name change (Incorporated by reference to
Registration Statement No. 333-02613 on Form S-3 filed with
the Securities and Exchange Commission on April 18, 1996
and Meridians Form 8-K filed with the Securities and
Exchange Commission on May 16, 2007) |
|
|
|
|
|
|
3.2 |
|
|
Amended Code of Regulations (Incorporated by reference to
Meridians Form 8-K filed with the Securities and Exchange
Commission on July 23, 2008) |
|
|
|
|
|
|
10.1 |
* |
|
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) |
|
|
|
|
|
|
10.2 |
* |
|
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) |
|
|
|
|
|
|
10.3 |
* |
|
1996 Stock Option Plan (Incorporated by reference to
Meridians Annual Report on Form 10-K for the Fiscal Year
Ended September 30, 1996) |
|
|
|
|
|
|
10.4 |
* |
|
Salary Continuation Agreement between Meridian Bioscience,
Inc. and John A. Kraeutler, as amended April 24, 2001 and
December 29, 2008 (Incorporated by reference to Meridians
Annual Report on Form 10-K for the Fiscal Year Ended
September 30, 2009) |
|
|
|
|
|
|
10.5 |
* |
|
1999 Directors Stock Option Plan (Incorporated by
reference to Meridians Proxy Statement filed with the
Securities and Exchange Commission on December 21, 1998) |
|
|
|
|
|
|
10.6 |
|
|
Dividend Reinvestment Plan (Incorporated by reference to
Meridians Annual Report on Form 10-K for the Fiscal Year
Ended September 30, 1999) |
|
|
|
|
|
|
10.7 |
* |
|
Employment Agreement Dated February 15, 2001, as amended
December 29, 2008 between Meridian and John A. Kraeutler
(Incorporated by reference to Meridians Annual Report on
Form 10-K for the Fiscal Year Ended September 30, 2009) |
|
|
|
|
|
|
10.8 |
* |
|
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) |
- 72 -
|
|
|
|
|
Exhibit Number |
|
Description of Exhibit |
|
|
|
|
|
|
10.9 |
* |
|
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) |
|
|
|
|
|
|
10.10 |
* |
|
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) |
|
|
|
|
|
|
10.11 |
* |
|
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) |
|
|
|
|
|
|
10.12 |
* |
|
Professional Services Agreement dated April 1, 2010 between
Meridian and Antonio Interno (Filed herewith) |
|
|
|
|
|
|
10.13 |
* |
|
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) |
|
|
|
|
|
|
10.14 |
* |
|
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) |
|
|
|
|
|
|
10.15 |
* |
|
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) |
|
|
|
|
|
|
10.16 |
* |
|
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) |
|
|
|
|
|
|
10.17 |
* |
|
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) |
|
|
|
|
|
|
10.18 |
|
|
Loan and Security Agreement among Meridian Bioscience, Inc.,
Meridian Bioscience Corporation, Omega Technologies, Inc. Meridian
Life Science, Inc. and Fifth Third Bank dated August 1, 2007
(Incorporated by reference to Meridians Annual Report on Form
10-K for the Fiscal Year Ended September 30, 2007) |
|
|
|
|
|
|
10.18.1 |
|
|
Amended and Restated Revolving Note with Fifth Third Bank dated
August 1, 2007 (Incorporated by reference to Meridians Annual
Report on Form 10-K for the Fiscal Year Ended September 30, 2007) |
|
|
|
|
|
|
10.18.2 |
|
|
First Amendment to Loan and Security Agreement among Meridian
Bioscience, Inc., Meridian Bioscience Corporation, Omega
Technologies, Inc., Meridian Life Science, Inc. and Fifth Third
Bank dated September 2, 2010 (Filed herewith) |
|
|
|
|
|
|
10.19 |
* |
|
Sample Time-Based Restricted Stock Agreement dated November 12,
2009 (Incorporated by reference to Meridians Annual Report on
Form 10-K for the Fiscal Year Ended September 30, 2009) |
- 73 -
|
|
|
|
|
Exhibit Number |
|
Description of Exhibit |
|
|
|
|
|
|
10.20 |
* |
|
Sample Performance Award Restricted Stock Agreement dated November 12, 2009
(Incorporated by reference to Meridians Annual Report on Form 10-K for the Fiscal Year
Ended September 30, 2009) |
|
|
|
|
|
|
10.21 |
|
|
Stock Purchase Agreement dated as of July 20, 2010 among Meridian Bioscience, Inc.,
Meridian Bioscience Europe, S.A. and Marco Giuseppe Calzavara and Vittorio Giovanni
Calzavara (Incorporated by reference to Meridians Form 8-K filed with the Securities
and Exchange Commission on July 23, 2010) |
|
|
|
|
|
|
13 |
|
|
2010 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 specific portions of the 2010 Annual Report to Shareholders are incorporated by reference
in this Form 10-K as filed herewith. A supplemental paper copy of the 2010 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.
- 74 -
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 29, 2010 |
|
|
|
John A. Kraeutler
Chief Executive Officer |
|
|
- 75 -
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
William J. Motto
|
|
Chairman of the Board of Directors
|
|
November 29, 2010 |
|
|
|
|
|
/s/ John A. Kraeutler
John A. Kraeutler
|
|
Chief Executive Officer, Director
|
|
November 29, 2010 |
|
|
|
|
|
/s/ Melissa A. Lueke
Melissa A. Lueke
|
|
Executive Vice President, Chief Financial Officer, and Secretary
|
|
November 29, 2010 |
|
|
|
|
|
/s/ James M. Anderson
James M. Anderson
|
|
Director
|
|
November 29, 2010 |
|
|
|
|
|
/s/ James A. Buzard
James A. Buzard
|
|
Director
|
|
November 29, 2010 |
|
|
|
|
|
/s/ Gary P. Kreider
Gary P. Kreider
|
|
Director
|
|
November 29, 2010 |
|
|
|
|
|
/s/ David C. Phillips
David C. Phillips
|
|
Director
|
|
November 29, 2010 |
|
|
|
|
|
/s/ Robert J. Ready
Robert J. Ready
|
|
Director
|
|
November 29, 2010 |
- 76 -
SCHEDULE II
Meridian Bioscience, Inc.
and Subsidiaries
Valuation and Qualifying Accounts
(Dollars in thousands)
Years Ended September 30, 2010, 2009 and 2008
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at |
|
|
Charged to |
|
|
|
|
|
|
|
|
|
|
Balance at |
|
|
|
Beginning |
|
|
Costs and |
|
|
|
|
|
|
|
|
|
|
End of |
|
Description |
|
of Period |
|
|
Expenses |
|
|
Deductions |
|
|
Other (a) |
|
|
Period |
|
Year Ended September 30, 2010: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Allowance for doubtful accounts |
|
$ |
247 |
|
|
$ |
82 |
|
|
$ |
(56 |
) |
|
$ |
(32 |
) |
|
$ |
241 |
|
Inventory realizability reserves |
|
|
1,025 |
|
|
|
717 |
|
|
|
(610 |
) |
|
|
(2 |
) |
|
|
1,130 |
|
Valuation allowances deferred
taxes |
|
|
470 |
|
|
|
|
|
|
|
|
|
|
|
(31 |
) |
|
|
439 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 |
|
|
|
|
(a) |
|
Balances reflect the effects of currency translation |
- 77 -