-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, KffG6iUx4rp1ButEzPi61PBzhXYcjidl/1+TighKRuajvINOWqo40QW6pK9oMrwM NJabBQshF+EZuNqgQ5+Rcw== 0001193125-09-154898.txt : 20090724 0001193125-09-154898.hdr.sgml : 20090724 20090724154151 ACCESSION NUMBER: 0001193125-09-154898 CONFORMED SUBMISSION TYPE: 10-K PUBLIC DOCUMENT COUNT: 9 CONFORMED PERIOD OF REPORT: 20090531 FILED AS OF DATE: 20090724 DATE AS OF CHANGE: 20090724 FILER: COMPANY DATA: COMPANY CONFORMED NAME: IMMUCOR INC CENTRAL INDEX KEY: 0000736822 STANDARD INDUSTRIAL CLASSIFICATION: IN VITRO & IN VIVO DIAGNOSTIC SUBSTANCES [2835] IRS NUMBER: 222408354 STATE OF INCORPORATION: GA FISCAL YEAR END: 0531 FILING VALUES: FORM TYPE: 10-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-14820 FILM NUMBER: 09962326 BUSINESS ADDRESS: STREET 1: 3130 GATWAY STREET 2: PO BOX 5625 CITY: NORCROSS STATE: GA ZIP: 30091 BUSINESS PHONE: 770 441 2051 MAIL ADDRESS: STREET 1: 3130 GATEWAY DR STREET 2: P O BOX 5625 CITY: NORCROSS STATE: GA ZIP: 30091-5625 10-K 1 d10k.htm FORM 10-K Form 10-K
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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-K

(Mark One)

 

x ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the fiscal year ended May 31, 2009

OR

 

¨ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from                      to                     

Commission file number 0-14820

IMMUCOR, INC.

(Exact name of registrant as specified in its charter)

 

Georgia   22-2408354
(State or other jurisdiction of incorporation or organization)   (I.R.S. Employer Identification No.)

3130 GATEWAY DRIVE,

P.O. BOX 5625

 
Norcross, Georgia   30091-5625
(Address of principal executive offices)   (Zip Code)

Registrant’s telephone number, including area code, is (770) 441-2051

Securities registered pursuant to Section 12(b) of the Act:

 

Title of Each Class   Name of Each Exchange on Which Registered
COMMON STOCK, $.10 PAR VALUE   The Nasdaq Stock Market LLC
COMMON STOCK PURCHASE RIGHTS  

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  x    No  ¨

Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act.    Yes  ¨    No  x

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 (or for such shorter period that the Registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.    Yes  x    No  ¨

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate website, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§ 229.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).    Yes  ¨    No  ¨

Indicate by a check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K is not contained herein, and will not be contained, to the best of registrant’s 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.  ¨

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 definition of “large accelerated filer,” “accelerated filer” and “small reporting company” in Rule 12b-2 of the Exchange Act.

 

Large accelerated filer  x

 

Accelerated filer  ¨

Non-accelerated filer  ¨

 

Small reporting company  ¨

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act).    Yes  ¨    No  x

As of November 30, 2008, the aggregate market value of the common stock held by non-affiliates of the registrant was $1,689,186,685, based upon the closing price on The Nasdaq Stock Market on that date. For the purpose of calculating this amount, all officers and directors have been treated as affiliates.

As of June 30, 2009, there were 70,486,265 shares of common stock outstanding.

DOCUMENTS INCORPORATED BY REFERENCE

Part III—Portions of the Registrant’s definitive Proxy Statement relating to the registrant’s 2009 Annual Meeting of Shareholders, to be filed with the Securities and Exchange Commission within 120 days following the end of the Company’s fiscal year, are incorporated by reference in Part III of this Annual Report on Form 10-K as indicated herein.

 

 

 


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Table Of Contents

 

Part I

     

Item 1.

  

Business

   3

Item 1A.

  

Risk Factors

   10

Item 1B.

  

Unresolved Staff Comments

   16

Item 2.

  

Properties

   16

Item 3.

  

Legal Proceedings

   16

Item 4.

  

Submission Of Matters To A Vote Of Security Holders

   17

Part II

     

Item 5.

  

Market For The Registrant’s Common Equity, Related Stockholder Matters And Issuer Purchases Of Equity Securities

   18

Item 6.

  

Selected Financial Data

   21

Item 7.

  

Management’s Discussion And Analysis Of Financial Condition And Results Of Operations

   22

Item 7A.

  

Quantitative And Qualitative Disclosures About Market Risk

   42

Item 8.

  

Financial Statements And Supplementary Data

   43

Item 9.

  

Changes In And Disagreements With Accountants On Accounting And Financial Disclosure

   77

Item 9A.

  

Controls And Procedures

   77

Item 9B.

  

Other Information

   78

Part III

     

Item 10.

  

Directors, Executive Officers And Corporate Governance

   79

Item 11.

  

Executive Compensation

   79

Item 12.

  

Security Ownership Of Certain Beneficial Owners And Management And Related Stockholder Matters

   79

Item 13.

  

Certain Relationships And Related Transactions, And Director Independence

   79

Item 14.

  

Principal Accountant Fees And Services

   79

Part IV

     

Item 15.

  

Exhibits And Financial Statement Schedules

   80

Signatures

   84

Ex-21

  

Subsidiaries Of The Registrant

  

Ex-23

  

Consents Of Experts And Counsel

  

Ex-31.1

  

Certificate Of Principal Executive Officer Pursuant To Rule 13a-14(a)

  

Ex-31.2

  

Certificate Of Principal Financial Officer Pursuant To Rule 13a-14(a)

  

Ex-32

  

Certifications Required Under Section 906 Of The Sarbanes-Oxley Act Of 2002

  

 

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PART I

FORWARD-LOOKING STATEMENTS

This annual report on Form 10-K contains forward-looking statements that are based upon current expectations and are made pursuant to the Safe Harbor Provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, without limitation, any statement that may predict, forecast, indicate, or imply future results, performance, or achievements, and may contain the words “believe”, “anticipate”, “expect”, “estimate”, “project”, “will be”, “will continue”, “will likely result”, or words or phrases of similar meaning. Forward-looking statements involve risks and uncertainties that may cause actual results to differ materially from the forward-looking statements. We intend that such statements be protected by the safe harbor created thereby. The risks and uncertainties are detailed from time to time in reports filed by us with the SEC, including Forms 8-K, 10-Q, and 10-K.

In addition, such statements are subject to the risks and uncertainties discussed in the “Risk Factors” section and elsewhere in this annual report on Form 10-K. The risks included here are not exhaustive. Other sections of this report may include additional factors that could adversely affect our business and financial performance. Moreover, we operate in a very competitive and rapidly changing environment. New risk factors emerge from time to time, and it is not possible for management to predict all such risk factors, nor can it assess the impact of all such risk factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. Given these risks and uncertainties, investors should not place undue reliance on forward-looking statements as a prediction of actual results.

Item 1.—Business.

Founded in 1982, Immucor, Inc., a Georgia corporation (“Immucor” or the “Company”), develops, manufactures and sells a complete line of reagents and automated systems that detect and identify certain properties of the cell and serum components of human blood for the purpose of blood transfusion. Our offerings are targeted at hospitals, donor centers and clinical laboratories.

Industry

We are part of the blood banking industry, which generally seeks to prevent transfusion reactions through testing prior to transfusion of blood and blood components. In the United States (U.S.), the Food and Drug Administration (“FDA”) regulates the transfusion of human blood as a drug and as a biological product. The FDA regulates all phases of the blood banking industry, including donor selection and the collection, classification, storage, handling and transfusion of blood and blood components. The FDA requires all facilities that manufacture products used for any of those purposes, and the products themselves, to be registered or licensed by the FDA. (See “Regulation” for further discussion.)

The principal components of blood are plasma (the fluid portion) and red cells. Blood also contains antibodies and antigens. Antibodies are proteins that are naturally produced by the human body in response to the introduction of foreign substances (antigens). Antigens are substances that stimulate the production of antibodies. Red blood cells, which transport oxygen from the lungs to other parts of the body and return carbon dioxide to the lungs, are categorized by four blood groups (A, B, AB and O) and two blood types (Rh positive and Rh negative), based on the presence or absence of certain antigens on the surface of the cells. It is crucial that the healthcare provider correctly identify the antibodies and antigens present in patient and donor blood. For example, if a donor’s red blood cells contain antigens that could react with the corresponding antibody in the patient’s plasma, the transfusion of the red blood cells may result in the potentially life-threatening destruction of the transfused red blood cells.

 

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Because of the critical importance of matching patient and donor blood, highly skilled and educated technologists in hospitals, donor centers and laboratories generally perform procedures for testing compatibility. At present, many of these tests are performed manually in the U.S., making blood testing laboratories much more labor intensive than other types of testing laboratories. In most markets outside of the U.S., a significant portion of the testing is automated.

We estimate the worldwide blood banking reagent and capital market at approximately $1 billion. The markets in which we have a direct distribution presence, the U.S., Canada, Western Europe and Japan, represent most of the addressable market today. We sell through distributors in other international markets.

Strategy and Long-Term Growth Drivers

Strategy

Our strategy is to drive automation in the blood bank. We began our automation strategy in 1998 with the goal of improving the operations of the blood bank as well as patient safety. Through our innovation, we believe that our Galileo® and Galileo Echo® (“Echo”) instruments are among the most functionally rich instrumentation available on the market.

We believe our customers, whether a hospital, a donor center or a reference laboratory, benefit from automation. Automation can allow customers to reduce headcount as well as overtime in the blood bank, which can be a benefit given the current shortage of qualified blood bank technologists. We also believe that automation can improve patient safety, increase operational efficiency and, for integrated delivery systems with more than one blood bank, can permit the standardization of best practices. For Immucor, automation allows us to gain market share and secure a long-term, contractual relationship with our customers.

We are now on our third generation automated instrument, the Echo. Launched worldwide in June 2007, the Echo is targeted at the market segment that is the least automated in the U.S.—small- to medium-sized hospitals. The Echo features STAT functionality, exceptional mean time between failures and what we believe is the fastest turnaround time in the industry. In the two years since its launch, we have received 603 orders worldwide through May 31, 2009, or approximately 10% of the estimated worldwide market.

We continue to innovate and expect to launch our fourth generation automated instrument, which will be named the Galileo Neo™, in the first quarter of calendar 2010. This next generation Galileo instrument will be targeted at large hospitals, donor centers and reference labs. We expect the Galileo Neo to have faster turnaround times, better mean times between failures and better functionality than the Galileo.

In August 2008, we invested in what we believe will be the future of the blood bank—molecular immunohematology—with our acquisition of privately-held BioArray Solutions (“BioArray”). BioArray pioneered the development of DNA typing of blood for transfusion. With the goal of improving transfusion medicine, we believe that molecular immunohematology will revolutionize blood bank operations. In many countries, blood pre-transfusion testing is limited to the prevention of transfusion reactions and not for the prevention of alloimmunization, which occurs when antigens foreign to the patient are inadvertently introduced into the patient’s blood system through transfusions. If alloimmunization occurs, the patient develops new antibodies in response to the foreign antigens, thereby complicating future transfusions. By using multiplex, cost-effective molecular testing, we plan to introduce a system that allows testing to prevent alloimmunization for better patient care. We are currently working on the next generation instrument to allow for the further commercialization of our molecular immunohematology technology. Our current timeline is to have a research use only instrument available in the first half of calendar 2011.

 

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Long-Term Growth Drivers

Our long-term growth drivers revolve around our automation strategy. We believe automation is the key to improving blood bank operations and patient safety, as well as increasing our market share around the world. In implementing our automation strategy, we are focused on the following:

 

  i) Product Innovations—We believe innovation is an important part of our strategy. We continually seek to improve existing products and develop new products to increase our market share and to improve the operations of our customers. We are currently developing a new version of the Galileo, which will be our fourth generation automated instrument. We are also currently developing new reagent tests for use on our automated instruments as well as in a manual testing environment, to further improve transfusion medicine. Turning to the new field of molecular immunohematology (discussed below), we are currently developing the next generation automated instrument for the DNA typing of blood for the purpose of transfusion, which we believe will be the future of blood bank operations.

 

  ii)

Instrument Placements—We believe that automation is the most effective way to gain market share as there are tangible benefits for the customers both in terms of operational efficiency and patient safety. We continually innovate to ensure our automation offerings are competitive and believe that our “Scalable Solutions” meet the needs of blood banks, regardless of size. Our instruments are “closed systems,” using our proprietary Capture® reagents. Our goal in placing instruments is to secure a long-term, contractual relationship with the customer for reagents. Each instrument placed typically provides us with a recurring revenue stream through the sale of reagents and supplies.

 

  iii) Standardize Pricing and Promote Customer Loyalty—We continue to follow our pricing strategy of having customers adhere to standardized pricing tiers. We also continue to offer a Customer Loyalty Program, which allows customers to achieve more favorable pricing through commitment to Immucor as a primary vendor. We expect these and other pricing adjustments to continue to have a favorable impact on our financial performance in the near term.

 

  iv) International Growth—We have direct distribution operations in Canada, Western Europe and Japan as well as a network of distributors in other parts of the world. We made investments in the United Kingdom and France during fiscal 2009 to sell directly to the end users (e.g. hospitals), although we had a previous presence in those markets through distributor arrangements. As of May 31, 2009, approximately 30% of our sales were from outside the United States. We believe that our innovative automation offerings as well as our proprietary and traditional reagent lines will enable us to continue to grow our market share outside the U.S.

 

  v) Molecular Immunohematology—Our acquisition of BioArray provides new, strategic growth markets for us, both in our current market of transfusion medicine through an offering complementary to our current product offerings as well as the potential new market of transplantation. We are currently working on the next generation molecular immunohematology instrument that will help us further commercialize this innovative technology. Our current timeline is to have a research use only instrument available in the first half of calendar 2011. We believe that bringing the DNA typing of blood for transfusion to the blood bank will revolutionize transfusion medicine. We believe that we are in the forefront of this exciting field with our acquisition of BioArray.

Traditional Reagents

A reagent is a substance that is added during a test in order to bring about a reaction. The resulting reaction is used to confirm the presence of another substance. Our reagents are used to identify different properties of blood for the purpose of transfusion.

Most of our current reagent products are used in tests to i) identify the blood group (A, B, AB, O) and type (Rh positive or negative) ii) to detect and identify red cell antibodies or red cell antigens, iii) to detect and identify platelet antibodies and iv) to determine blood compatibility (crossmatch). The FDA requires the accurate testing of blood and blood components for the purpose of transfusion, using only FDA licensed reagents.

 

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Under traditional agglutination blood testing techniques (manual method), the technologist manually mixes serum with red blood cells in a test tube, performs several additional procedures, and then examines the mixture to determine whether there has been an agglutination reaction. A positive reaction occurs if the cells are drawn together in clumps by the presence of corresponding antibodies and antigens. Due to the critical importance of matching patient and donor blood, testing procedures using agglutination techniques are usually performed manually by highly educated and skilled technologists.

We estimate that approximately 70% of the blood banks in the U.S. perform their testing on a manual basis without the use of an automated instrument. These blood banks are primarily in the small- to medium-hospital segment of the market.

Traditional reagents accounted for approximately two-thirds of our revenue in fiscal 2009. We believe there is a slight amount of seasonality to our reagent business as fewer donations and elective surgical procedures are performed in our first fiscal quarter (June-August).

Proprietary Technology Platform

Solid Phase Technology. Our instruments use both our proprietary solid phase technology, marketed under the name Capture, as well as certain manual reagents to perform tests. In our proprietary solid phase blood test system, red cell or platelet antigens are bound to a solid support like a microtitration plate (the solid phase), and the bound reactant captures other reactants in a fluid state and binds those fluid reactants to the solid phase. In this testing system, patient or donor serum or plasma is placed in the well of a plastic microtitration plate on which antigen reactants have been bound. Special proprietary indicator cells manufactured by Immucor are then added. In a positive reaction, antibodies in the test sample are captured by the indicator cells and adhere to the bottom of the test well as a thin layer. In a negative reaction, there is no antibody attached to the indicator cells and they settle to the bottom of the test well as a small cell button. These reactions occur rapidly and result in clearly defined, machine-readable test results that are often easier to interpret than the subjective results sometimes obtained from existing agglutination technology. Also, in batch test mode the solid phase test results can generally be obtained in substantially less time than by traditional agglutination techniques.

We have obtained FDA clearance for the sale of five test systems using our solid phase technology: a platelet antibody detection system, Capture-P; a red cell antibody detection system, Capture-R and Capture-R Select, used for antibody screening, identification, phenotyping, cross matching and in the weak D test; and two infectious disease tests, Capture-CMV and Capture-S.

Molecular Immunohematology Technology. Our molecular immunohematology technology, which was obtained in August 2008 through our acquisition of BioArray, is marketed under the name the BeadChip™ system. BioArray developed a novel and flexible technology platform that allows for a variety of multiplex DNA-based testing, combining DNA amplification (PCR) with Beach Chip detection and data analysis software. The platform combines semiconductor technology, microparticle chemistry and molecular biology to bring a high degree of flexibility and performance to qualitative and quantitative DNA and protein analyses. Multiplex Human Erythrocyte Antigen (HEA), Human Platelet Antigen (HPA), and HLA-A/HLA-B Bead Chip kits are currently available to the market with Hemoglobinopathies/SCD, and Rh Bead Chip systems in development. The BeadChip system is available for research use only.

Instruments and Instrument Systems

We offer customers a selection of automated analyzers, marketed as Scalable Solutions, which address the various needs of low, medium, and high-volume testing facilities. While we design and own the rights to our instruments, we contract with third-party manufacturers for their production.

 

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GALILEO—The Galileo, targeted at large-volume hospitals, clinical reference laboratories and blood donor centers, provides a fully-automated solution to perform all routine blood bank tests, including blood grouping, antibody screening, crossmatch, direct antiglobulin test (DAT), antibody identification, cytomegalovirus (CMV) and syphilis screening. We initially sold the Galileo in Europe in 2002 and then in 2004 it was introduced in the United States. A high throughput instrument, Galileo can process up to 224 different samples at once, and can perform approximately 60 type-and-screen tests an hour. The Galileo uses our proprietary Capture reagent products. We believe that the Galileo has the highest type and screen throughput available in the global market. We also believe that the Galileo’s throughput and broad test menu gives it an advantage in all the markets in which we compete.

GALILEO ECHO—The Echo, targeted at small- to medium-sized hospitals, was cleared for sale in the U.S. in June 2007 and was also registered for distribution in Canada, Western Europe and Japan. The Echo has many of the features of the Galileo, including a broad test menu. Echo has the capacity to load 20 samples at a time and can perform approximately 14 type-and-screen tests an hour. We believe the Echo has the fastest turnaround time of any instrument in the global market, with a type-and-screen test result available in 20 minutes, which gives it an advantage in all markets in which we compete. The Echo’s target users are the largest segment of our market, numbering approximately 6,000 worldwide.

CAPTURE WORKSTATION (Semi-automated Processor)—The Capture Workstation has semi-automated components for performing our proprietary Capture assays manually. It is marketed as a back-up system for our fully-automated Galileo and Echo, or as a standalone test system for small laboratories looking to standardize testing.

Research and Development

We continually seek to improve our existing products and to develop new ones in order to increase our market share. Prior to sale, any new product requires licensing or pre-market clearance from the FDA in the U.S. and CE marking in Western Europe. For the fiscal years ended May 31, 2009, 2008, and 2007, we spent approximately $10.7 million, $6.5 million, and $6.4 million, respectively, for research and development.

Marketing and Distribution

Our potential customers are donor centers, hospitals and clinical laboratories. No single customer represents 10% or more of our annual consolidated revenue.

We have a direct sales presence in the U.S., Canada, Western Europe and Japan. We sell through distributors in other regions of the world. We offer several instrument procurement options, including direct sales and rentals.

Backlog

As of May 31, 2009, we had orders for approximately 243 Echos and 41 Galileos that were not generating recurring reagent revenue at their expected annualized run rates. These instrument orders have been received but the instruments have either not been installed or the customer validation process has not been completed so the instruments are not generating recurring reagent revenue at their expected annualized run rates. While the instrument backlog is not material as of May 31, 2009, the follow on reagent revenue will contribute to revenue growth in the future. At May 31, 2009, in accordance with U.S. generally accepted accounting principles, we had not recognized approximately $22.1 million in revenue from instrument sales contracts that had reagent price protection and from extended warranty sales.

Suppliers

We obtain raw materials from numerous outside suppliers and believe our business relationships with them are good. Certain of our products are derived from blood having particular or rare combinations of antibodies or

 

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antigens, which are found in a limited number of individuals. To date, we have not experienced any major difficulty in obtaining sufficient quantities of such blood for use in manufacturing our products, but there can be no assurance that a sufficient supply of such blood will always be available to us.

We source our instruments from two single-source suppliers. The Echo is manufactured for us by Bio-Tek Instruments, Inc. and the Galileo is manufactured for us by Stratec Biomedical AG. While these relationships are significant, our business is not substantially dependent upon them because we believe that other manufacturers could supply the instruments to us after a reasonable transition period. We believe that our business relationship with our instrument suppliers is excellent. We have elected not to dual source our instruments because we consider our primary exposure to be the sudden bankruptcy of one or both suppliers. In the event a current instrument supplier experiences financial problems that prevent it from continuing to produce our instrument, we believe it would take in the range of 18 months to 24 months to transfer the technology and begin production with a new instrument supplier. While a change in an instrument supplier would disrupt our growth opportunities during the transition period, we do not believe it would have a material financial impact on our existing business as approximately 90% of our revenue is generated from our reagents.

Regulation

The manufacture and sale of blood banking products is a highly regulated business and is subject to continuing compliance with multiple U.S., Canadian, Western European, Japanese and other country-specific statutes, regulations and standards that generally include licensing, product testing, facilities compliance, product labeling, post-market vigilance and consumer disclosure.

In the U.S., an FDA facility license is issued for an indefinite period of time, subject to the FDA’s right to revoke the license. As part of its overview responsibility, the FDA makes plant and facility inspections on an unannounced basis. In 2006, we consolidated the Gamma Biologicals, Inc., Houston facility (U.S. Government Establishment License No. 435) under the Immucor, Inc. License No. 886, and subsequently discontinued operations at the Houston facility in December 2007. In 2008, we received FDA approval for the transfer of manufacturing activities to Norcross and an expansion of our manufacturing facilities at the same location.

In addition, each product manufactured by us is subject to formal product submissions and review processes by the FDA and other regulatory bodies, such as Health Canada, the European recognized Notified Body and the Japanese Ministry of Health prior to authorization to market. Significant changes to our products or facilities can require additional submission and review prior to implementation. For example, we hold several FDA product licenses to manufacture blood-grouping reagents, anti-human globulin reagents and reagent red blood cells. We must submit biological product license applications or 510(k) pre-market notifications to the FDA to obtain product licenses or market clearance for new products or instruments. To accomplish this, we must submit detailed product information to the FDA, perform a clinical trial of the product, and demonstrate to the satisfaction of the FDA that the product meets certain efficacy and safety standards. There can be no assurance that any future product licenses or instrument clearances will be obtained by us.

Our manufacturing facilities worldwide are certified to ISO 13485:2003. This is an internationally recognized standard and certification is required in order to continue product distribution in key markets such as Europe and Canada. In addition, to continue marketing our products to the European Union, we are required to maintain certification under the EC Full Quality Assurance System Assessment in accordance with the requirements of Annex IV of the IVD Medical Devices Directive 98/79/EC. This certification authorizes the use of the CE mark on our products that allows products free access to all countries within the European Union. We successfully completed certifications for CE marking of all products manufactured for the European market with the exception of our molecular immunohematology products produced by BioArray. We are in the process of completing CE mark certifications for our molecular immunohematology products.

 

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In addition to the U.S., Western Europe, Canada and Japan, there are multiple countries worldwide that also impose regulatory barriers to market entry. We continue to maintain product registrations and approvals necessary to maintain access to foreign markets.

On June 26, 2009, we announced that the FDA, in an administrative action based on a January 2009 inspection, issued a notice of intent to revoke our biologics license with respect to our Reagent Red Blood Cells and Anti-E (Monoclonal) Blood Grouping Reagent products. Under this administrative action, we have the opportunity to demonstrate or achieve compliance before the FDA initiates revocation proceedings or takes other action. The FDA did not order the recall of any of our products or restrict us from selling these products. This administrative action was a follow on to a warning letter that we received in May 2008. We had been working on an FDA-approved remediation plan, submitted after the warning letter, but had failed to make adequate progress at the time of the FDA’s follow up January 2009 inspection. During our fiscal third quarter of 2009, we formalized efforts to improve our quality systems through the Quality Process Improvement Project. The Project significantly expanded the role of consultants hired in April 2008. We continue to implement the Project and believe that in addition to addressing the deficiencies noted by the FDA we will have a world-class quality system upon its completion. We expect the Project to be completed during our third fiscal quarter of 2010.

Environmental

Some of our processes generate hazardous waste and we have a U.S. Environmental Protection Agency identification number. All hazardous material is manifested and disposed of properly. We are in compliance with applicable portions of the federal and state hazardous waste regulations and have never been a party to any environmental proceeding.

Patents and Trademarks

Since 1986, the U.S. Patent Office has issued six patents to us pertaining to our solid phase technology, four of which have expired. The remaining two patents expire in 2010 and 2012. We believe the remaining patents, together with our trade secrets and know-how, will help prevent any current or future competitors from successfully copying and distributing our solid phase products.

When we acquired BioArray in August 2008, we acquired approximately 100 issued or pending patents that BioArray had generated through its substantial investments in research and development. Through the development of technologies supported by the patents, BioArray developed a novel and flexible technology platform that allows for a variety of DNA-based testing. The platform combines semiconductor technology, microparticle chemistry and molecular biology to bring a high degree of flexibility and performance to quantitative DNA and protein analysis. Using this technology platform, BioArray developed complete assay solutions called the BeadChip system. These patents expire between 2018 and 2025.

Several of the products we sell are trademarked. These trademarks are protected by registration in the United States and other countries where such products are marketed. We consider these trademarks in the aggregate to be of material importance in the operation of our businesses.

Competition

Competition in the blood banking industry is based on quality of instrumentation and reagents, pricing, talent of the sales forces, ability to furnish a range of quality existing and new products, reliable technology, skilled and trained technicians, customer service and continuity of product supply. We believe we are well positioned to compete favorably in this industry principally because of the completeness, reliability and quality of our product line, competitive pricing structure and introduction of new innovative products such as our full line of automated instruments and our Capture technology. We also believe that continuing research efforts in the area of blood bank automation, the experience and expertise of our sales personnel and the expertise of our technical and customer support staff will enable us to remain competitive in the market.

 

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In the United States and Canada, Ortho-Clinical Diagnostics (“Ortho”), a Johnson & Johnson company, is our main competitor. In Western Europe, our principal competitors are DiaMed AG, a Swiss company acquired by Bio-Rad Laboratories, Inc. (“Bio-Rad”) in October 2007, and Ortho. Both Ortho and Bio-Rad sell instrumentation as well as reagents. Other competitors in the U.S. and Western Europe include Hemo Bioscience, Grifols Diagnostics and Biotest. Our principal competitor in Japan is Ortho.

Financial Information about Geographic Areas

We conduct our business globally with manufacturing facilities in the United States and Canada. We have sales operations in the U.S., Canada, several Western European countries and Japan. Roughly 30% of our revenues are generated by our international affiliates. In addition to the potentially adverse impact of foreign regulations (see “Regulations”), we may also be affected by tougher market conditions outside the U.S., which could impact our revenues and profit margins. Also, there may be adverse consequences from fluctuations in foreign currency exchange rates, which may affect the competitiveness of our products and our profit margins because our affiliates sell our products predominantly in local currencies, but our cost structure is weighted towards the U.S. dollar.

For financial information about geographic areas, see Note 16 “Domestic and Foreign Operations” of the notes to the consolidated financial statements.

Employees

At May 31, 2009, we had a total of 729 full-time employees worldwide. We have a low staff turnover rate and consider our employee relations to be good. In addition to our full-time work force, we employ temporary and contract employees. None of our employees are represented by a labor union.

Available Information

We file reports, proxy statements and other information under the Securities Exchange Act of 1934 with the Securities and Exchange Commission (the “SEC”). Electronic versions of our annual report on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K and any amendments to these reports filed or furnished with the SEC may be accessed free of charge through our website at www.immucor.com. The information may also be accessed at the Commission’s web site at www.sec.gov.

Item 1A.—Risk Factors.

We are subject to various risks and uncertainties relating to or arising out of the nature of our business and general business, economic, financing, legal and other factors or conditions that may affect us. We provide the following cautionary discussion of risks and uncertainties relevant to our business, which we believe are factors that, individually or in the aggregate, could have a material and adverse impact on our business, results of operations and financial condition, or could cause our actual results to differ materially from expected or historical results. You should understand that it is not possible to predict or identify all such factors. Consequently, our business operations could also be affected by additional factors that are not presently known to us or that we currently consider to be immaterial to our operations.

Risks Relating to Our Company

FDA administrative action could have a material and adverse effect on our business.

On June 26, 2009, we announced that the Food and Drug Administration (“FDA”), in an administrative action based on a January 2009 inspection, issued a notice of intent to revoke our biologics license (NOIR) with respect to our Reagent Red Blood Cells and Anti-E (Monoclonal) Blood Grouping Reagent products. As part of

 

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its overview responsibility, the FDA makes plant and facility inspections on an unannounced basis. The FDA could seek to escalate the NOIR, for example, by issuing a consent decree or revoking our biologics license for the products impacted if we fail to implement a corrective action plan that adequately addresses the deficiencies noted by the NOIR. The FDA could also take further regulatory actions, including recalls or seizures of our products, a total or partial shutdown of production, delays in future marketing clearances or approvals, and withdrawals or suspensions of our current products from the market.

On-going antitrust investigations and litigation could have a material and adverse effect on our business.

As noted in Item 3 below, we are under investigation by the Department of Justice (“DOJ”) concerning possible criminal violations of the antitrust laws, and we are also the subject of a number of private civil actions alleging price fixing and seeking class certification. The DOJ could seek an indictment and conviction against us, which could result in the imposition of substantial fines, among other remedies. Were plaintiffs to prevail in one or more of the pending civil actions, we also could have to pay significant amounts, including treble damages and attorneys’ fees. Also as noted in Item 3 below, the Federal Trade Commission (“FTC”) is investigating whether Immucor violated federal antitrust laws or engaged in unfair methods of competition, through three acquisitions made in the period from 1996 through 1999 or by restricting price competition. The FTC could decide to commence administrative and possibly federal court proceedings for purposes of determining whether there has been a violation and might seek to impose a variety of remedies for any violation including injunctive relief, divestiture of assets and/or disgorgement of profits. The imposition of any of the above remedies could have a materially adverse impact on our business, financial condition and results of operations. In addition, regardless of the ultimate outcome in the above matters, we expect to incur significant expenses, including attorneys’ fees, in responding to and defending against issues raised in the above matters.

A catastrophic event at our Norcross, Georgia facility would prevent us from producing many of our reagent products.

Substantially all our reagent products are produced in our Norcross facility. While we have reliable supplies of most raw materials, our reagent production is highly dependent on the uninterrupted and efficient operation of the Norcross facility, and we currently have no plans to develop a third-party reagent manufacturing capability. Therefore, if a catastrophic event occurred at the Norcross facility, such as a fire or tornado, many of those products could not be produced until the manufacturing portion of the facility was restored and cleared by the FDA. We maintain a disaster plan to minimize the effects of such a catastrophe, and we have obtained insurance to protect against certain business interruption losses. However, 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.

Unforeseen product performance problems could prevent us from selling or result in a recall of the affected products.

In the event that we experience a product performance problem with either our instruments or our reagents, we may be required to voluntary recall or suspend selling the products until the problem is resolved. Depending on the product as well as the availability of acceptable substitutes, such a product recall or suspension could significantly impact our operating results.

Poor product performance could increase operating costs and result in the loss of current or future customers.

Instrument performance and reliability is a key factor in satisfying current customers and attracting new customers. Poor performance or unreliability of instruments would not only increase maintenance costs but also could result in losing important customers. Therefore, if we are unable to provide effective instrument support and service and minimize instrument down time, our revenues and financial results would be adversely affected.

 

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We are highly dependent on our senior management team and other key employees, and the loss of one or more of these employees could adversely affect our operations.

Our success is dependent upon the efforts of our senior management and staff, including sales, technical and management personnel, many of whom have very specialized industry and technical expertise that is not easily replaced. If key individuals leave us, we could be adversely affected if suitable replacement personnel are not quickly recruited. Our future success depends on our ability to continue to attract, retain and motivate qualified personnel. There is intense competition for medical technologists and in some markets there is a shortage of qualified personnel in our industry. If we are unable to continue to attract or retain highly qualified personnel, the development, growth and future success of our business could be adversely affected.

If customers delay integrating our instruments into their operations, the growth of our business could be negatively impacted.

From time to time in the past, some of our customers have experienced significant delays between the purchase of an instrument and the time at which it has been successfully integrated into the customer’s existing operations and is generating reagent revenue at the expected annualized run rate. These delays may be due to a number of factors, including staffing and training issues and difficulties interfacing our instruments with the customer’s computer systems. Because our business operates on a “razor/razorblade” model, such integration delays result in delayed purchases of the reagents used with the instrument. A number of steps have mitigated these integration delays: improved performance of our field service staff, better instrument instructions, increased use of internet-based remote diagnostic tools, and more efficient scheduling of instrument installations. In addition, we have taken steps in the design of our next generation instruments intended to make it easier for our customers to integrate the instruments into existing operations. However, with the launch of the Echo we are placing many more instruments than in previous years, compounding integration problems, and the continuation of integration delays could adversely impact our future revenues and earnings growth.

We may not be successful in capitalizing on the acquisition of our former distribution businesses outside the U.S.

An integral part of our strategy is to place our instruments in additional markets outside North America. To further this strategy, in the past few years we have acquired our former distribution businesses in Japan, France and the U.K. Our ability to grow successfully in overseas markets depends in part on our ability to achieve product acceptance and customer loyalty in these markets. Additionally, our operations in foreign countries present certain challenges and are subject to certain risks not necessarily present in our domestic operations, such as fluctuations in currency exchange rates, shipping delays, changes in applicable laws and regulations and various restrictions on trade. These factors could impact our ability to compete successfully in these markets, which could in turn negatively affect our international expansion goals, and could have a material adverse effect on our operating results.

Because we sell our products internationally, we could be adversely affected by fluctuations in foreign currency exchange rates.

In the fiscal year ended May 31, 2009, our foreign net sales, including net U.S. export sales to unaffiliated customers, accounted for approximately 30% of our total net sales. As a result, fluctuations in foreign currency exchange rates, particularly the Euro, Canadian Dollar and Yen against the U.S. Dollar, could make our products less competitive and affect our sales and earnings levels. An increase in our foreign sales would increase this exposure. We have not historically hedged against currency exchange rate fluctuations, but may do so in the future if the exposure increases.

 

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Our financial performance is highly dependent on the timely and successful introduction of new products and services.

Our financial performance depends in large part upon our ability to successfully develop and market next generation and new instruments and other products in a rapidly changing technological and economic environment. Our market share and operating results would be adversely affected if we fail to successfully identify new product opportunities and timely develop and introduce new instruments that achieve market acceptance, or if new products or technology are introduced in the market by competitors that could render Immucor’s instruments or reagents uncompetitive or obsolete. In addition, delays in the introduction of new products due to regulatory, development, or other obstacles could negatively impact our revenues, earnings and market share.

Our instruments are produced by single source suppliers.

We purchase our instruments from two single-source suppliers. If the supply of either instrument were interrupted, due to the supplier’s financial problems or otherwise, we believe an alternative supplier could be found but it would take in the range of 18 months to 24 months to transfer the technology and begin production with a new instrument supplier. The disruption of one of these supply relationships could cause us to incur costs associated with the development of an alternative source. Also, we may be required to obtain FDA clearance of the instrument if it is not built to the same specifications as with the previous supplier. The process of changing an instrument supplier could have an adverse impact on future growth opportunities during the transition period if supplies of finished goods on hand were insufficient to satisfy demand.

We may be unable to adequately protect our proprietary technology.

As part of our August 2008 BioArray acquisition, we acquired approximately 100 issued or pending patents that BioArray had generated through its substantial investments in research and development. Also, two of the original six patents on our proprietary solid-phase technology are still in force. Our ability to compete in molecular immunohematology markets, through BioArray, and our ability to compete in traditional reagent markets, depends in part on our ability to maintain the proprietary nature of our owned and licensed intellectual property. There can be no assurance as to the degree of protection offered by our various patents, or with regard to licensed intellectual property, that the licenses will not be terminated. We believe our patents, together with our trade secrets and know-how, will prevent any current or future competitors from successfully copying and distributing our BeadChip and solid phase products. However, there can be no assurance that competitors will not develop around the patented aspects of any of our current or proposed products, independently develop technology or know-how that is the same as or competitive with our technology and know-how or otherwise obtain access to our intellectual property. If we are unable to maintain the proprietary nature of our intellectual property and our significant current or proposed products, our revenues and results of operations may be adversely affected.

Protecting our intellectual property rights is costly and time consuming. We may need to initiate lawsuits to protect or enforce our patents, or litigate against third party claims, which would be expensive and, if we lose, may cause us to lose some of our intellectual property rights and reduce our ability to compete in the marketplace. Furthermore, these lawsuits may divert the attention of our management and technical personnel.

Gross margin volatility may negatively impact our profitability.

Our gross margin may be volatile from period to period due to various factors, including instrument sales, reagent product mix and manufacturing costs. As we continue to drive automation in the blood bank marketplace and experience increased instrument sales as a result, the probable sales mix (in terms of instrument/reagent sales) could make it difficult for us to sustain the overall gross margins we have generated in the past. The higher margins on the Capture reagents used on our instruments may not be enough to offset the lower margins on the

 

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instruments themselves. Moreover, if the sales mix of instruments include more capital purchases and fewer rentals, there is likely to be further pressure on our overall gross margin because Emerging Issues Task Force (“EITF”) Issue No. 00-21, Accounting for Revenue Arrangements with Multiple Deliverables, requires that, for sales made on a purchase basis, the cost of the instrument be expensed upfront and the corresponding revenue be spread over the entire sales contract period for sales contracts with reagent price guarantees. For our reagent products, margins vary depending upon the product with rarer products demanding much higher prices, and therefore, higher margins. Depending upon the sales mix of these products, margins could vary significantly from period to period. Our reagent products are manufactured in-house. Margins for these products could be impacted based upon costs of raw materials and labor as well as overhead and the efficiency of our manufacturing operations from period to period. Margins may also be negatively impacted by increased competition. New market entrants or existing market participants seeking to gain market share may foster a competitive environment of pricing pressures and/or increased marketing and other expenditures that could negatively impact profitability.

We have been, and may in the future be, subject to intellectual property rights infringement claims, which are costly to defend, could require us to pay substantial damages and could limit our ability to use certain technologies in the future.

Our commercial success depends, in part, not only on protecting our own intellectual property but on not infringing the patents or proprietary rights of third parties. From time to time we may receive notices from, or have lawsuits filed against us by, third parties claiming that we infringe on their intellectual property rights. Responding to such claims, regardless of their merit, can be time consuming, result in costly litigation, divert management’s attention and resources and cause us to incur significant expenses. Our practices, products and technologies, particularly with respect to BioArray’s operations in the field of molecular immunohematology, may not be able to withstand third party claims, regardless of the merits of such claims.

As a result of such intellectual property infringement claims, we could be required or otherwise decide it is appropriate to discontinue manufacturing, using, or selling particular products subject to infringement claims or develop other technology not subject to infringement claims, which could be time consuming and costly or may not be possible. In addition, to the extent claims against us are successful, we may have to pay substantial monetary damages or discontinue certain of our practices, products or technologies that are found to be in violation of another party’s rights. We also may have to seek third-party licenses to continue certain of our existing or planned product lines, thereby incurring substantial costs related to royalty payments for such licenses, which could negatively affect our gross margins, No assurance can be given that such efforts to remediate any infringement will be successful or that licenses can be obtained on acceptable terms or that litigation will not occur.

In the event there is a temporary or permanent injunction entered prohibiting us from marketing or selling certain of our products, or a successful claim of infringement against us requiring us to pay royalties to a third party, and we fail to license such technology on acceptable terms and conditions or to develop or license a substitute technology, our business, results of operations or financial condition could be materially adversely affected. Further, any adverse ruling or perception of an adverse ruling in defending ourselves against these claims could have a material adverse impact on our stock price, which may be disproportionate to the actual significance of the ruling itself.

Declining global economic conditions may have a material adverse impact on our results.

Immucor is a global company with operations in North America, Europe and Japan and customers around the world. General economic conditions impact our customers, particularly hospitals. For our instruments that are primarily sold on a capital purchase basis, reduced capital budgets that result from negative economic conditions, such as the current global recession, could result in lower instrument sales, which would negatively impact our future revenue, profitability and cash flow. A shift from capital purchases to rentals, which require no upfront

 

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cash outlay, could negatively impact our cash flow in the near term. Additionally, current global economic conditions may adversely affect the ability of our customers to access funds to enable them to fund their operating and capital budgets. Capital budget constraints could slow our progress in driving automation in both our customer base and the blood banking industry as a whole, which could negatively impact our future revenues, profitability and cash flow.

Risks Relating to our Industry

Government regulation may delay or prevent new product introduction and affect our ability to continue manufacturing and marketing existing products.

Our instruments, reagents and other products are subject to regulation by governmental and private agencies in the United States and abroad, which regulate the testing, manufacturing, packaging, labeling, distribution and marketing of medical supplies and devices. Certain international regulatory bodies also impose import and tax restrictions, tariff regulations, and duties on imported products. Delays in agency review can significantly delay new product introduction and may result in a product becoming “outdated” or losing its market opportunity before it can be introduced. Also, the FDA and international agencies have the authority to require a recall or modification of products in the event of a defect.

FDA clearance generally is required before we can market new instruments or reagents in the United States or make significant changes to existing products. The process of obtaining marketing clearances and approvals from regulatory agencies for new products can be time consuming and expensive. There is no assurance that clearances or approvals will be granted or that agency review will not involve delays that would adversely affect our ability to commercialize our products.

If any of our products failed to perform in the manner represented during this clearance process, particularly concerning safety issues, one or more of these agencies could require us to cease manufacturing and selling that product, or even recall previously-placed products, and to resubmit the product for clearance before we could sell it again. Depending on the product, and the availability of acceptable substitutes, such an agency action could result in significantly reduced revenues and earnings for an indefinite period.

Federal, state and foreign regulations regarding the manufacture and sale of our products are subject to change. We cannot predict what impact, if any, such changes might have on our business. In addition, there can be no assurance that regulation of our products will not become more restrictive in the future and that any such development would not have a material adverse effect on our business.

The industry and market segment in which we operate are highly competitive, and we may not be able to compete effectively with larger companies with greater financial resources than we have.

Our industry and markets we operate in are highly competitive. Some of our competitors have greater financial resources than we do, making them better equipped to fund research and development, manufacturing and marketing efforts, or license technologies and intellectual property from third parties. Moreover, competitive and regulatory conditions in many markets in which we operate restrict our ability to fully recoup our costs in those markets. Our competitors can be expected to continue to improve the design and performance of their products and to introduce new products with competitive price and performance characteristics. Although we believe that we have certain technological and other advantages over our competitors, maintaining these advantages will require us to continue to invest in research and development, sales and marketing and customer service and support. We cannot assure you that we will have sufficient resources to continue to make such investments at levels that our larger competitors can make or that we will be successful in maintaining such advantages.

 

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Increased competition in the United States could negatively impact our revenues and profitability.

For fiscal 2009, approximately 70% of our revenues were generated in the U.S., and these sales have been at increasingly larger gross margins. These results could be significantly and negatively impacted if current or new competitors increase their competition based on price, thereby potentially reducing our market share and gross margins. In calendar 2008, a new competitor entered the traditional blood bank reagent market in the United States. Their reagent products are intended for use by donor centers, reference laboratories, and hospitals for pre-transfusion blood group serology testing. The new market entrant has begun to aggressively market these products, which could cause us to reduce prices and/or increase marketing and other expenditures, or could result in the loss of business, all of which could reduce revenues and profitability.

In calendar 2009, a European instrument competitor acquired a European reagent manufacturer whose products are also sold in the U.S. We believe the combination of these two companies may result in increased competition in the U.S.

We may be exposed to product liability claims resulting from the use of products we sell and distribute.

Although product liability claims in our industry are infrequent, the expansion of our business in an increasing litigious business environment may expose us to product liability claims related to the products we sell. We maintain insurance that includes product liability coverage and we believe our insurance coverage is adequate for our business. However, there can be no assurance that insurance coverage for these risks will continue to be available or, if available, that it will be sufficient to cover potential claims or that the present level of coverage will continue to be available at a reasonable cost. A partially or completely uninsured successful claim against us could have a material adverse effect on us.

Item 1B.—Unresolved Staff Comments.

Not applicable.

Item 2.—Properties.

Our corporate office and main manufacturing facilities along with laboratories and warehouses are leased and are located in Norcross, Georgia. We lease our sales offices in the Western European countries in which we operate and in Japan, with the exception of our Belgium sales office, which we own. We also own our Canadian manufacturing facility. Upon acquisition of BioArray in the first quarter of fiscal 2009, we acquired leased property in Warren, New Jersey, which is the manufacturing facility for our molecular immunohematology products.

Our owned properties are not encumbered as security for any loan. We believe that our current facilities are adequate for our current and anticipated needs and do not foresee any difficulty in renewing leases that expire in the near term.

Item 3.—Legal Proceedings.

In October 2007, we reported that the Federal Trade Commission (“FTC”) was investigating whether Immucor violated federal antitrust laws or engaged in unfair methods of competition through three acquisitions made in the period from 1996 through 1999, and whether Immucor or others engaged in unfair methods of competition by restricting price competition. The FTC letter requested that we provide certain documents and information to the FTC concerning those acquisitions and concerning our product pricing activities since then. On July 11, 2008, the FTC formalized its document and information requests into a Civil Investigative Demand (“CID”) and also required us to provide certain additional information within the same general scope of its previous requests. We have been cooperating with the FTC and we intend to continue cooperating, and we are

 

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assured that the issuance of a formal CID does not indicate any dissatisfaction with our cooperation. As was previously the case, at this time we cannot reasonably assess the timing or outcome of the investigation or its effect, if any, on our business.

In April 2009, we received a subpoena from the United States Department of Justice, Antitrust Division (“DOJ”), requiring us to produce documents for the period beginning September 1, 2000 through the present, pertaining to an investigation of possible violations of the federal criminal antitrust laws in the blood reagents industry. We have been cooperating with the DOJ and we intend to continue cooperating. At this time we cannot reasonably assess the timing or outcome of the investigation or its effect, if any, on our business.

Since May 18, 2009, a series of 30 lawsuits have been filed in 10 different United States District Courts against the Company, Ortho-Clinical Diagnostics, Inc. and Johnson & Johnson Health Care Systems, Inc. alleging that the defendants conspired to fix prices at which blood reagents are sold, asserting claims under Section 1 of the Sherman Act, and seeking declaratory and injunctive relief, treble damages, costs, and attorneys’ fees. These cases are identified in Exhibit 99.1, which is hereby incorporated herein by this reference. All of these complaints make substantially the same allegations and seek to certify a class of persons and entities who purchased blood reagents from any of the defendants between January 1, 2000 and the present. Most of the complaints limit the proposed class to persons and entities in the United States, but some do not contain that limitation. Certain of the plaintiffs have filed motions with the Judicial Panel on Multidistrict Litigation asking that these cases be centralized in a single United States District Court; arguments on these motions are scheduled to be heard July 30, 2009. Discovery has not yet begun in any of these cases. None of the courts has made a determination whether any of the plaintiffs’ claims have merit or should be allowed to proceed as a class action. We intend to vigorously defend against these cases. At this time we cannot reasonably assess the timing or outcome of this litigation or its effect, if any, on our business.

Other than as set forth above, we are not currently subject to any material legal proceedings, nor, to our knowledge, is any material legal proceeding threatened against us. However, from time to time, we may become a party to certain legal proceedings in the ordinary course of business.

Item 4.—Submission of Matters to a Vote of Security Holders.

During the fourth quarter of fiscal year 2009, no matters were submitted to a vote of the security holders.

 

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PART II

Item 5.—Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities.

Our common stock trades on The Nasdaq Stock Market under the symbol: BLUD. The following table sets forth the quarterly high and low prices of the common stock for the fiscal periods indicated as reported on The Nasdaq Stock Market.

 

     High    Low

Fiscal Year Ended May 31, 2009

     

First Quarter

   $ 33.13    $ 24.71

Second Quarter

     33.80      21.17

Third Quarter

     29.20      21.34

Fourth Quarter

     26.09      13.75

Fiscal Year Ended May 31, 2008

     

First Quarter

   $ 34.69    $ 26.48

Second Quarter

     39.96      29.58

Third Quarter

     34.97      26.55

Fourth Quarter

     29.75      17.30

As of June 30, 2009, there were 379 holders of record of our common stock, which excludes shareholders whose shares were held by brokerage firms, depositories and other institutional firms in “street name” for their customers.

Dividend Policy

We have never declared cash dividends with respect to our common stock. We presently intend to continue to reinvest our earnings in the business.

Equity Compensation Plan Information

In 2005, our Board of Directors adopted, and the shareholders approved, the Immucor, Inc. 2005 Long-Term Incentive Plan (the “2005 Plan”). The 2005 Plan replaced our preexisting stock option plans, which have been frozen and remain in effect only to the extent of awards outstanding under these plans. Under the 2005 Plan, the Company is able to award stock options, stock appreciation rights, restricted stock, deferred stock, and other performance-based awards as incentive and compensation to employees and directors. Awards for up to 3,600,000 shares of the Company’s common stock may be granted under the 2005 Plan. There is a restriction on the number of shares that may be used for awards other than stock options (1,800,000), and a separate restriction on the number of shares that may be used for grants of incentive stock options (also 1,800,000), but there is no restriction on the number of shares that may be used for grants of non-incentive stock options. Options are granted at the closing market price on the date of the grant. Option awards generally vest equally over a four-year period and have a six-year contractual term. Restricted stock awards generally vest equally over a five-year period. The 2005 Plan provides for accelerated vesting of option and restricted stock awards if there is a change in control, as defined in the plan.

 

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The following table provides information as of May 31, 2009 with respect to the shares of our common stock that may be issued under our existing equity compensation plans:

 

Plan category

   Number of
securities to be
issued upon exercise of
outstanding options,
warrants and rights
   Weighted average
exercise price of
outstanding
options, warrants
and rights
   Number of
securities remaining
available for future
issuance ***

Equity compensation plans approved by security holders *

   2,445,368    $ 20.16    1,876,773

Equity compensation plans not approved by security holders **

   251,918    $ 0.89    —  
                

Total

   2,697,286    $ 17.30    1,876,773
                

 

* Includes our 1998 Stock Option Plan, 2003 Stock Option Plan and 2005 Plan.
** Includes our 1990 Stock Option Plan and 1995 Stock Option Plan.
*** Number of securities available for future issuance represents securities available under the 2005 Plan. At May 31, 2009, options had been granted under the 2005 Plan to purchase 1,654,009 shares of common stock and 232,215 shares of restricted stock had been granted; all of the 1,876,773 remaining shares, which include 162,997 cancelled awards, are available for issue under the 2005 Plan. No securities are available for future issuance under any of the other plans, which were frozen when the 2005 Plan was adopted. For a description of the material features of the 2005 Plan, see Note 12 to the consolidated financial statements.

Stock Repurchase Program

We are currently authorized to repurchase in aggregate up to 9,375,000 shares of our common stock under the stock repurchase program instituted in June 1998 with the initial authorization to repurchase up to 6,075,000 shares of our common stock. Since 1998, we have repurchased 8,528,353 shares of our common stock having an aggregate value of approximately $57.6 million. During the fiscal year ended May 31, 2009, we repurchased 295,409 shares of our commons stock for $6.7 million. As of May 31, 2009, 846,647 shares were available for repurchase under the program.

The Company repurchased shares of its Common Stock under the Company’s stock repurchase plan during the three-month period ended May 31, 2009 as indicated in the table below:

 

Period

   Shares
Purchased
   Average Price
Per Share
   Shares Purchased to
Date as Part of Publicly
Announced Plan
   Maximum # of Shares
Available to Purchase
Under the Plan

March 1-31, 2009

   —      $ —      8,432,944    942,056

April 1-30, 2009

   95,409    $ 20.67    8,528,353    846,647

May 1-31, 2009

   —      $ —      8,528,353    846,647

 

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Performance Graph

The following performance graph compares the cumulative total shareholder return on an investment of $100 in our common stock for the last five fiscal years with the total return of the S & P 500 and an old Peer Group Index and a new Peer Group Index for our last five fiscal years. The only other U.S. public company engaged in the blood bank reagent business is Johnson & Johnson through its Ortho-Clinical Diagnostics business unit. Due to the size and diversity of Johnson and Johnson, we do not believe it to be a true peer. For this reason, the new Peer Group is comprised of the following publicly traded companies: (1) Meridian Bioscience, Inc.; (2) Gen-Probe, Inc.; (3) Haemonetics Corp. and (4) Qiagen NV, which we consider peers because they are medical technology companies without large pharmaceutical operations. The old Peer Group Index also included Ventana Medical Systems, Inc., which is not a part of the new Peer Group Index because it ceased trading publicly last year.

LOGO

 

* $100 invested on 5/31/04 in stock or index, including reinvestment of dividends. Fiscal year ending May 31.

Copyright © 2009, S&P, a division of The McGraw-Hill Companies, Inc. All rights reserved.

 

     5/31/04    5/31/05    5/31/06    5/31/07    5/31/08    5/31/09

Immucor, Inc.  

   100.00    241.74    196.72    341.72    290.32    162.85

S&P 500

   100.00    108.24    117.59    144.39    134.72    90.84

Old Peer Group

   100.00    99.04    145.22    154.94    175.89    127.90

New Peer Group

   100.00    109.89    144.91    159.06    180.95    148.97

The stock price performance included in this graph is not necessarily indicative of future stock price performance.

 

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Item 6.—Selected Financial Data.

(All amounts are in thousands, except per share amounts)

 

     For the Year Ended May 31,  
     2009
(2)
    2008
(2)
    2007
(2)
    2006
(1)(2)
    2005
(1)(2)
 

Statement of Income Data:

          

Net sales

   $ 300,547      $ 261,199      $ 223,678      $ 183,506      $ 144,786   

Cost of sales

     84,536        75,710        65,923        61,969        57,541   
                                        

Gross profit

     216,011        185,489        157,755        121,537        87,245   
                                        

Operating expenses:

          

Research and development

     10,698        6,454        6,354        4,623        4,463   

Selling, general, and administrative

     88,355        70,646        58,738        51,185        45,530   

Restructuring expenses

     —          646        1,051        2,689        —     
                                        

Total operating expenses

     99,053        77,746        66,143        58,497        49,993   
                                        

Income from operations

     116,958        107,743        91,612        63,040        37,252   
                                        

Other:

          

Interest income

     1,957        4,263        2,841        978        624   

Interest expense

     (250     (371     (432     (516     (662

Other (expense) income—net

     (1,684     33        133        (342     767   
                                        

Total other

     23        3,925        2,542        120        729   
                                        

Income before income taxes

     116,981        111,668        94,154        63,160        37,981   

Income taxes

     40,798        40,214        34,086        23,317        14,071   
                                        

Net income

   $ 76,183      $ 71,454      $ 60,068      $ 39,843      $ 23,910   
                                        

Income per share:

          

Per common share—Basic

   $ 1.08      $ 1.02      $ 0.88      $ 0.59      $ 0.35   
                                        

Per common share—Diluted

   $ 1.07      $ 1.00      $ 0.85      $ 0.56      $ 0.34   
                                        

Weighted average shares outstanding:

          

Common shares

     70,382        69,867        68,441        68,004        67,699   
                                        

Common shares—assuming dilution

     71,168        71,109        70,669        71,401        71,350   
                                        
     May 31,  
     2009     2008     2007     2006     2005  

Balance Sheet Data:

          

Working capital

   $ 192,562      $ 230,556      $ 162,865      $ 92,883      $ 70,945   

Total assets

     451,340        364,950        275,478        191,687        157,613   

Long-term obligations, less current portion

     —          —          3,488        3,980        2,991   

Retained earnings

     327,242        251,059        179,768        119,700        79,857   

Shareholders’ equity

     384,578        307,696        219,448        143,871        117,432   

 

(1) All share and per share amounts have been retroactively adjusted to reflect the May 2006, December 2004 and July 2004 three-for-two stock splits.
(2) No cash dividend was declared during any of the five years.

 

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Item 7.—Management’s Discussion and Analysis of Financial Condition and Results of Operations.

Refer to “Forward Looking Statements” following the Index and Item 1A “Risk Factors” of this Form 10-K.

Overview

Our Business

We develop, manufacture and sell a complete line of reagents and automated systems used primarily by hospitals, clinical laboratories and donor centers in tests performed to detect and identify certain properties of human blood for the purpose of blood transfusion. We have manufacturing facilities in the United States (U.S.) and Canada and sell our products through our direct sales network in the U.S., Canada, Western Europe and Japan as well as through third-party distributors in other markets.

We operate in a highly regulated industry and are subject to continuing compliance with multiple country-specific statutes, regulations and standards. For example, in the U.S. the Food and Drug Administration (“FDA”) regulates all aspects of the blood banking industry, including the marketing of reagents and instruments used to detect and identify blood properties.

In the markets of Western Europe, the testing of donor and patient blood for the purpose of transfusion is primarily automated. However, in the U.S., we estimate approximately 70% of blood banks perform this testing manually today. These blood banks are primarily in the small- to medium-sized hospital segment.

Our strategy is to drive automation in the blood bank with the goal of improving the blood bank’s operations as well as patient safety. We have introduced several instruments in the past, and we continue to focus on developing new instruments and improving our existing instruments. We received FDA clearance in June 2007 to market our Galileo Echo® (“Echo”) instrument. The Echo is a compact bench top, fully-automated walk-away instrument that meets the needs of the small- to medium-sized hospital market as well as integrated delivery networks that want to standardize the operations of their blood banks. Like our high volume Galileo® instrument, Echo uses Capture® technology, our proprietary reagents, and offers an extensive test menu and significant labor reduction while increasing productivity and patient safety.

In fiscal 2009, we entered the field of molecular immunohematology with our purchase of BioArray Solutions.

BioArray Acquisition

On August 4, 2008, we acquired BioArray Solutions Ltd. (“BioArray”), a privately-held company based in Warren, New Jersey for an aggregate purchase price of $115.2 million in cash, including approximately $2.4 million of acquisition-related transaction costs. We have included the financial results of BioArray in our consolidated financial statements beginning August 4, 2008. BioArray will continue to be based in Warren and operate under the BioArray name.

The transaction costs included a payment of $1.4 million to TM Capital Corp., an investment bank which has represented the Company in a number of financial transactions, including the BioArray acquisition. Michael S. Goldman, one the Company’s former directors, is a Managing Director and founding principal of TM Capital Corp. With the receipt of these fees, as of August 4, 2008, Mr. Goldman no longer qualified as an “independent” director of the Company under Nasdaq Stock Market listing standards. As a result, Mr. Goldman resigned his positions as a member of the Compensation Committee and Governance Committee of the Board of Directors as of August 4, 2008 and did not stand for re-election at the 2008 annual meeting of shareholders.

BioArray pioneered the development of molecular diagnostic systems that enable the DNA typing (genotyping) of blood for transfusion donors and recipients. In this transaction, we acquired the broad intellectual

 

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property portfolio BioArray generated through its substantial investments in research and development, including approximately 100 issued or pending patents. Through the development of technologies supported by the patents, BioArray developed a novel and flexible technology platform that allows for a variety of DNA-based testing. The platform combines semiconductor technology, microparticle chemistry and molecular biology to bring a high degree of flexibility and performance to qualitative and quantitative DNA and protein analysis. Using this technology platform, BioArray offers complete assay solutions called the BeadChip™ system.

The BeadChip system includes BeadChips featuring proprietary array designs as well as an automated Array Imaging System with “snapshot” image acquisition and the ImageStudio™ suite of integrated image analysis programs. The resulting integrated assay delivery system enables users to simultaneously perform dozens of customized tests on each patient sample in a semi-automated fashion. We believe this versatility makes the BeadChip format ideally suited to a wide scope of applications. The BeadChip system, which has not yet received FDA approval, is currently installed in a number of leading donor and transfusion centers for research applications.

We believe that molecular immunohematology, or the DNA analysis of blood for the purpose of transfusions, will revolutionize transfusion medicine. We believe that our acquisition of BioArray provides new, strategic growth markets for the Company in both our current market of transfusion through an offering complementary to our current product offerings as well as the potential new market of transplantation. Our leadership in blood banking industry automation and BioArray’s leadership in molecular diagnostic systems for specialty transfusion applications should allow us to develop and deliver more precise molecular immunohematology solutions to enhance patient outcomes.

We also believe our proven strength in developing automated instruments combined with our FDA licensing and CE Mark process experience, our established distribution network, our sales and marketing capabilities as well as our financial resources will generate enhanced long-term growth opportunities for the commercialization of BioArray’s BeadChip system.

In connection with the transaction, BioArray formed a new company intended to commercialize BioArray’s technology in fields outside of blood transfusion and transplantation. The former equity holders of BioArray received an 81% ownership interest in the new company, and Immucor, through BioArray and for no additional consideration, received a 19% ownership interest. In the allocation of the BioArray purchase price, no value was allocated to Immucor’s interest in the new company. In April 2009, Immucor bought back the rights to the BioArray technology from the new company for approximately $1.0 million. As part of the liquidation of the new company, Immucor received approximately $140,000 in cash from the net assets, proportional to Immucor’s ownership interest.

We are currently working on the next generation molecular immunohematology instrument that will facilitate the further commercialization of this innovative technology. Our current timeline is to have a research use only instrument available in the first half of calendar 2011.

Recent Developments

Two significant recent developments are the acquisition of BioArray and the development of the next generation automated instrument to allow the full scale commercialization of our acquired molecular immunohematology offering, which are discussed above under “BioArray Acquisition.” The following discusses other recent developments in our business.

 

   

Continued market penetration of the Echo instrument—We launched our latest instrument, the Echo, in the first quarter of fiscal 2008. Targeted at the small- to medium-sized hospital market, Echo features STAT functionality, exceptional mean time between failures and what we believe is the fastest turnaround time in the industry. We expect Echo to appeal to the small- to medium-sized hospitals, the largest segment of our market, numbering approximately 6,000 worldwide. As of May 31, 2009, we

 

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had received orders for a total of 603 Echo instruments worldwide. We believe continued market penetration of Echo will be a growth driver for the Company.

 

   

Upcoming launch of Galileo Neo—We are currently developing a new version of the Galileo, named the Galileo Neo, which will be our fourth generation automated instrument. We believe the original Galileo, which was launched in Western Europe in 2002 and in the U.S. in 2004, is approaching its natural replacement cycle of 5-7 years. Galileo Neo, like the original Galileo, will be targeted at high volume customers: large hospitals, donor centers and reference laboratories. We expect the Galileo Neo will have faster turnaround times and a longer mean time between failures than the current Galileo as well as new features such as STAT functionality. We expect FDA clearance towards the end of calendar 2009 and a first calendar quarter 2010 launch for Galileo Neo.

 

   

International Expansion—During fiscal 2009, we took steps to enable us to sell directly to the end users (e.g., hospitals) in the markets of the United Kingdom (“U.K.”) and France, where we previously sold our products through distributors. In the U.K., we acquired our distributor in June 2008, and in France, we established our own operations, an effort that began in fiscal 2008. While we have roughly one-third of the worldwide market, approximately 70% of our revenue is derived from the U.S. We believe that through our innovative automation and reagent offerings we can expand our footprint in our overseas markets.

 

   

FDA Administrative Action—On June 26, 2009, we announced that the FDA, in an administrative action based on a January 2009 inspection, issued a notice of intent to revoke our biologics license with respect to our Reagent Red Blood Cells and Anti-E (Monoclonal) Blood Grouping Reagent products. Under this administrative action, we have the opportunity to demonstrate or achieve compliance before the FDA initiates revocation proceedings or takes other action. The FDA did not order the recall of any of our products or restrict us from selling these products. This administrative action was a follow on to a warning letter that we had received in May 2008. We had been working on an FDA-approved remediation plan, submitted after the warning letter, but had failed to make adequate progress at the time of the FDA’s follow up January 2009 inspection. During our fiscal third quarter of 2009, we formalized efforts to improve our quality systems through the Quality Process Improvement Project, which is discussed in further detail below. We continue to implement the Project and believe that, in addition to addressing the deficiencies noted by the FDA, we will have a world-class quality system upon its completion. We expect the Project to be completed during our third fiscal quarter of 2010.

 

   

Quality Process Improvement Project—During our third fiscal quarter of 2009, we formalized our efforts to improve the processes and procedures of our quality department through establishing the Quality Process Improvement Project. The Project expanded the role of consultants hired in April 2008. The Project’s objective is to deliver on our commitment of maintaining a world-class quality system. During fiscal 2009, we spent approximately $2.4 million on the Project, which was primarily reflected in cost of goods sold. We expect to incur $4.0 million to $4.5 million of Project-related expenses in fiscal 2010. The Project expenses primarily represent the cost of external consultants who are assisting us with the Project. We are targeting to complete the Project during our third fiscal quarter of 2010.

 

   

The U.S. Department of Justice Subpoena—On April 24, 2009, we announced that we had received a subpoena from the U.S. Department of Justice, Antitrust Division related to an investigation of possible violations of the federal criminal antitrust laws in the blood reagents industry. The subpoena requires us to produce documents for the period beginning September 1, 2000 through the present. We are cooperating fully with the Department of Justice.

 

   

Antitrust Lawsuits—Since May 2009, a series of 30 lawsuits have been filed against Immucor, Ortho-Clinical Diagnostics, Inc and Johnson & Johnson Health Care Systems, Inc. alleging that those companies conspired to fix blood reagent prices. These lawsuits are in the preliminary stages.

 

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Instruments

In the past two fiscal years, we continued our focus of increasing market share and, therefore, revenue through the execution of our automation strategy. We have had strong market acceptance of our Echo instrument and have continued executing our pricing strategy to drive automation. We believe innovation is a key competitive advantage we have in the industry. To that end, our development of the next generation Galileo instrument, the Galileo Neo, continues and we expect a first calendar quarter 2010 worldwide launch of our new high volume offering. Additionally, in fiscal 2009, we believe that our acquisition of BioArray positions us as a first mover in the exciting new field of molecular immunohematology. We believe that the DNA typing of blood for transfusion will revolutionize transfusion medicine. We are currently in the process of developing the next generation molecular immunohematology instrument that will help us further commercialize the BioArray technology. Our current timeline is to have a research use only instrument available in the first half of calendar 2011.

Instrument placements are at the core of our automation strategy and we track instrument orders as an indication of our progress. For markets in which we sell directly to the end user (e.g., a hospital), the process is as follows: we receive the order, we schedule installation of the instrument and customer staff training, the customer performs validation testing of the instrument, the instrument begins generating recurring reagent revenue at its expected annualized run rate. As of May 31, 2009, we had received orders for a total of 603 Echo instruments worldwide since the instrument’s launch in June 2007, including 121 orders in Europe including distributors, 470 orders in the U.S. and Canada, and 12 orders in Japan. Approximately 360 of these Echo instruments were generating reagent revenue at the expected annualized run rate at the end of fiscal 2009. We believe the market for Echo worldwide is approximately 6,000 hospitals, the largest segment of our market. For Galileo, as of May 31, 2009, we had received a total of 637 Galileo instruments orders worldwide since launch, including 365 orders in Europe (including distributors), 266 orders in the U.S. and Canada, and 6 orders in Japan. Approximately 596 of these Galileo instruments were generating reagent revenues at the expected annualized run rate at the end of fiscal 2009.

Revenue and expenses related to the sale of instruments is accounted for under Emerging Issues Task Force (“EITF”) Issue No. 00-21, Accounting for Revenue Arrangements with Multiple Deliverables. EITF 00-21 mandates the deferral of certain revenue for sales agreements that have multiple deliverables while also mandating the upfront expensing of the related costs. The reagent contracts that are signed when customers automate typically have reagent price guarantee clauses. In accordance with EITF 00-21, when instruments are sold (versus rented) the instrument costs are expensed when the sale is made and the related instrument revenue is deferred and recorded as income over the term of the underlying reagent contract. If an instrument is rented, then the revenue and expenses are recognized ratably over the contract period. While the overall transaction economics may be similar, this accounting treatment may result in margin improvement or degradation depending on the sales mix of instruments purchased or rented by the end users in the period. Historically, the Galileo is purchased 90% of the time. For the Echo, in fiscal 2009, we experienced a rental rate of more than 75% for new instrument orders in the U.S. As of May 31, 2009 and May 31, 2008, we had deferred revenue of approximately $22.1 million and $24.2 million, respectively, and a major portion of these balances related to the deferral of revenue from sales of instruments.

 

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Results of Operations

Comparison of Years Ended May 31, 2009 and May 31, 2008

 

     For the Year Ended May 31,     Change  
             2009                     2008             Amount     %  
     ($ in thousands)        

Net Sales

   $ 300,547      $ 261,199      $ 39,348      15%   

Gross profit (1)

     216,011        185,489        30,522      16%   

Gross profit percentage

     71.9     71.0     n/m      1%   

Operating expenses

     99,053        77,746        21,307      27%   
                          

Income from Operations

     116,958        107,743        9,215      9%   

Non-operating income

     23        3,925        (3,902   -99%   
                          

Income before income tax

     116,981        111,668        5,313      5%   

Provision for income tax

     40,798        40,214        584      1%   
                          

Net income

   $ 76,183      $ 71,454      $ 4,729      7%   
                          

Earnings per share:

        

Per common share—basic

   $ 1.08      $ 1.02      $ 0.06      6
                          

Per common share—diluted

   $ 1.07      $ 1.00      $ 0.07      7
                          

 

(1) The determination of gross margin is exclusive of amortization expense which is presented separately as an operating expense in the income statement.

Revenue increased by approximately $39.3 million, or approximately 15%, during the year ended May 31, 2009 compared with the prior year. This increase was primarily attributable to approximately $27.3 million from price contributions, which included incremental revenue from both contractual and discretionary sources, and approximately $15.7 million from volume contributions, which included incremental revenue from instrument placements. These increases were offset by a negative currency impact of approximately $3.7 million. Approximately 70% of our fiscal 2009 consolidated revenue is from the U.S. and 30% is from international sales largely denominated in local currency, with the majority of this revenue in Euros, Canadian Dollars, British Pounds and Yen. As a result, our consolidated revenue expressed in dollars benefits when the U.S. dollar weakens and decreases when the U.S. dollar strengthens in relation to other currencies.

For fiscal 2009, our consolidated gross margin increased to 71.9% from 71.0% achieved in fiscal 2008, primarily due to margin improvements in traditional reagents and instruments. During the current fiscal year, we spent approximately $2.4 million on our Quality Process Improvement Project, which was primarily reflected in cost of sales. Operating expenses increased approximately 27%, primarily due to our acquisition of BioArray. Net income increased approximately 7% in fiscal 2009 over the prior year.

Net sales

 

     For the Year Ended May 31,    Change
             2009                    2008            Amount     %
     ($ in thousands)      

Traditional reagents

   $ 199,277    $ 179,088    $ 20,189      11%

Capture reagents

     64,145      53,372      10,773      20%

Instruments

     34,672      27,042      7,630      28%

Molecular immunohematology

     2,453      —        2,453      100%

Collagen

     —        1,697      (1,697   -100%
                        
   $ 300,547    $ 261,199    $ 39,348      15%
                        

 

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Traditional reagent revenue increased by approximately $20.2 million, or approximately 11%, in fiscal 2009 compared with fiscal 2008 primarily due to price contributions, which included incremental revenue from both contractual and discretionary sources. Traditional reagent sales, which accounted for approximately two-thirds of total revenue in fiscal 2009, have historically been a significant portion of our revenue. We expect our revenue mix to change over time as we place more instruments in the market, which results in increased sales of our Capture reagents.

Capture revenue increased by approximately $10.8 million, or approximately 20%, in fiscal 2009 over the prior year primarily due to increased volume. Sales of Capture reagents are largely dependent on the number of installed instruments requiring the use of our proprietary Capture technology. As we continue to place more instruments in the market, we expect revenue from Capture reagents to continue to increase.

Revenue from instruments increased by approximately $7.6 million, or approximately 28% in fiscal 2009 compared with fiscal 2008 due to increased instrument placements. Historically, revenue from instrument sales in the United States has been recognized over the life of the underlying reagent contract when it includes a price guarantee, which is normally five years. In fiscal 2009, approximately $16.9 million of deferred revenue was recognized from previously placed instruments compared to $13.3 million recognized in fiscal 2008. We deferred approximately $14.7 million of instrument and associated service revenues related to instrument placements in fiscal 2009, compared to $17.5 million in fiscal 2008. We had increased rentals of instruments in the current year, which resulted in revenue being recognized over the term of the contract as earned, versus deferred and amortized as in the case of the instrument being sold. As of May 31, 2009 and May 31, 2008, deferred instrument and service revenues totaled approximately $22.1 million and $24.2 million, respectively.

The sale of molecular immunohematology products produced by BioArray resulted in $2.5 million in revenue during fiscal 2009. BioArray was acquired on August 4, 2008.

We discontinued manufacturing collagen products in the second quarter of fiscal 2008 when our commitment to a third party expired, which resulted in a revenue decrease of $1.7 million in fiscal 2009.

Gross margin

 

     For the Year Ended May 31,        
     2009     2008     Change
Amount
 
     Amount    Margin %     Amount    Margin %    
     (in ‘000)          (in ‘000)          (in ‘000)  

Traditional reagents (1)

   $ 155,744    78.2   $ 139,428    77.9   $ 16,316   

Capture reagents (1)

     54,411    84.8     45,568    85.4     8,843   

Instruments (1)

     5,259    15.2     476    1.8     4,783   

Molecular immunohematology (1)

     597    24.3     —      0.0     597   

Collagen (1)

     —      0.0     17    1.0     (17
                          
   $ 216,011    71.9   $ 185,489    71.0   $ 30,522   
                          

 

(1) The determination of gross margin is exclusive of amortization expense which is presented separately as an operating expense in the income statement.

Gross margins on traditional reagents increased to 78.2% in fiscal 2009 from 77.9% in the prior year, primarily due to higher revenue without a proportionate increase in cost of sales. During the current fiscal year, we spent approximately $2.4 million on our Quality Process Improvement Project. These costs were primarily reflected in traditional reagent cost of sales.

 

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For fiscal 2009, Capture product gross margins decreased to 84.8% from 85.4% in the prior year primarily due to foreign currency fluctuations and product sales mix.

Gross margins on instruments increased to 15.2% in fiscal 2009 from 1.8% in the prior year, primarily due to sales mix. In the prior year, more instruments were sold and in the current year more instruments were rented. Where sales contracts have reagent price guarantee clauses (which our automation contracts typically do), instrument costs are expensed when the sale is made, but the related instrument revenue is deferred and recorded as income over the term of the contract. When an instrument is rented, revenue and expenses for the transaction are recognized evenly over the life of the contract. Additionally, current year margins benefited from the recognition of revenue deferred from prior periods. In fiscal 2009, we recognized $3.6 million more deferred revenue than in the prior year.

Operating expenses

 

     For the Year Ended May 31,    Change
             2009                    2008            Amount     %
     ($ in thousands)      

Research and development

   $ 10,698    $ 6,454    $ 4,244      66%

Selling and marketing

     39,191      32,970      6,221      19%

Distribution

     13,708      11,394      2,314      20%

General and administrative

     31,717      25,925      5,792      22%

Restructuring expense

     —        646      (646   -100%

Amortization expense and other

     3,739      357      3,382      947%
                        

Total operating expenses

   $ 99,053    $ 77,746    $ 21,307      27%
                        

Research and development expenses increased by approximately $4.2 million in fiscal 2009 over the prior year, primarily due to the acquisition of BioArray, which took place in the first quarter of this fiscal year, and the development activities around the acquired molecular immunohematology offering.

Selling and marketing expenses increased by approximately $6.2 million in fiscal 2009 compared with fiscal 2008, primarily due to the addition of new affiliates in France and the United Kingdom, and the BioArray acquisition.

Distribution expenses rose by approximately $2.3 million in fiscal 2009 over the prior year, primarily due to an increase in freight charges and other general expenses.

General and administrative expenses increased by approximately $5.8 million in fiscal 2009 over the prior year, primarily due to the addition of BioArray and our affiliates in the United Kingdom and France.

Amortization expense increased by approximately $3.4 million in fiscal 2009 compared with fiscal 2008 due to amortization of finite-lived intangibles that were recorded upon the acquisition of BioArray and our affiliate in the United Kingdom. Both acquisitions occurred in the first quarter of this fiscal year.

Non-operating income

 

     For the Year Ended May 31,    Change
Amount
 
             2009                    2008           
     ($ in thousands)  

Non-operating income

   $ 23    3,925    $ (3,902
                    

 

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The year-over-year decrease in non-operating income was primarily attributable to lower interest income due to our lower cash balance as well as a decrease in interest rates. Cash on hand was lower in fiscal 2009 as a result of the acquisitions made in the first fiscal quarter. Additionally, non-operating income was lower as a result of higher foreign exchange losses related to an intercompany receivable.

Income taxes

The provision for income taxes increased $0.6 million in fiscal 2009 compared with fiscal 2008 primarily due to increased pre-tax income. The effective income tax rate was 34.9% in the current year compared with 36.0% in the prior year. The tax rates in the current year periods were favorably impacted primarily by an increase in research and development credits following the BioArray acquisition and lower statutory rates in Italy.

As a result of using compensation cost deductions arising from the exercise of nonqualified employee stock options and vesting of restricted shares for federal and state income tax purposes, we realized income tax benefits of approximately $3.3 million in fiscal 2009 and $7.5 million in fiscal 2008. The majority of the exercises that contribute to the tax benefit are exercises of options that were granted prior to the adoption of SFAS 123(R). Therefore, as required by U.S. generally accepted accounting principles, these income tax benefits are recognized in our financial statements as additions to additional paid-in capital rather than as reductions of the respective income tax provisions in the consolidated financial statements because the related compensation deductions were not recognized as compensation expense for financial reporting purposes. Our income tax liability is reduced by these amounts.

Comparison of Years Ended May 31, 2008 and May 31, 2007

 

     For the Year Ended May 31,     Change
             2008                     2007             Amount    %
     ($ in thousands)     

Net Sales

   $ 261,199      $ 223,678      $ 37,521    17%

Gross profit

     185,489        157,755        27,734    18%

Gross profit percentage

     71     71     n/m   

Operating expenses

     77,746        66,143        11,603    18%
                         

Income from operations

     107,743        91,612        16,131    18%

Non-operating income

     3,925        2,542        1,383    54%
                         

Income before income tax

     111,668        94,154        17,514    19%

Provision for income tax

     40,214        34,086        6,128    18%
                         

Net income

   $ 71,454      $ 60,068      $ 11,386    19%
                         

Net sales increased by 17% and operating expenses increased by 18% in fiscal 2008 as compared to fiscal 2007 and this resulted in an increase in net income for fiscal 2008 of $11.4 million, 19% higher than fiscal 2007. Of the $11.6 million, or 18%, increase in operating expenses, the weakening of the U.S. Dollar against foreign currencies in fiscal 2008 accounted for approximately $3.1 million, or 27% of the total increase. A large portion of the remaining increase in operating expenses was related to the launch of Echo and related personnel costs for new technical and sales staff. Diluted earnings per share totaled $1.00 for fiscal 2008, as compared to diluted earnings per share of $0.85 for the prior year, an increase of 18%.

United States operations continue to generate a majority of our revenue and operating income. U.S. operations generated 73% and 93%, respectively, of our revenue and operating income in fiscal 2008 compared to 73% and 89%, respectively, in fiscal 2007.

 

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Net sales

 

     For the Year Ended May 31,    Change
             2008                    2007            Amount     %
     ($ in thousands)      

Traditional reagents

   $ 179,088    $ 159,941    $ 19,147      12%

Capture products

     53,372      42,720      10,652      25%

Instruments

     27,042      16,927      10,115      60%

Collagen

     1,697      4,090      (2,393   -59%
                        
   $ 261,199    $ 223,678    $ 37,521      17%
                        

Of the $37.5 million total increase in revenues in the year ended May 31, 2008 compared to fiscal 2007, approximately $23.6 million came from price increases in the United States, approximately $2.2 million came from volume increases in the United States, approximately $7.3 million was attributable to the effect of the changes in the Euro, Japanese Yen and Canadian Dollar exchange rates and approximately $4.4 million came from sales increases, including instrument revenues, outside the United States.

The 12% growth in traditional reagent revenue (i.e. products not using our patented Capture technology) in fiscal 2008 compared to fiscal 2007 occurred mainly as a result of price increases in the United States. Traditional reagent sales have historically been our primary source of revenue and still constitute roughly 69% of our revenue. We expect the significance of this line of products to gradually decline as we place more instruments in the market and increase sales of our Capture products.

Sales of Capture products increased by $10.7 million, or 25%, in fiscal 2008 compared to fiscal 2007 mainly due to volume increases ($5.0 million) and price increases ($3.0 million) in the U.S., exchange rate gains ($2.1 million) due to the strengthening of the Euro against the U.S. Dollar and an increase ($0.6 million) attributable to our foreign affiliates. Sales of Capture products are largely dependent on the number of installed instruments requiring the use of Capture reagents. As we succeed in placing more instruments in the market, we expect revenue from Capture products to increase.

Revenue from instruments increased by 60% in fiscal 2008 compared to fiscal 2007. In fiscal 2008, $13.3 million of deferred revenue was recognized from previously placed instruments compared to $8.4 million recognized in fiscal 2007. Most instrument sales in the United States are recognized over the life of the underlying reagent contract, which is normally five years. In fiscal 2008 approximately $17.5 million of instrument sales and associated service revenues were deferred in this manner, compared to $11.9 million in fiscal 2007. As of May 31, 2008 and May 31, 2007, deferred instrument and service revenues totaled $24.2 million and $19.7 million, respectively. We expect to place more Galileo and Echo instruments in the market.

We discontinued manufacturing collagen products in the second quarter of fiscal 2008 when our commitment to a third party expired. This action resulted in a revenue decrease of $2.4 million in fiscal 2008, compared to revenue earned from these products in fiscal 2007.

 

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Gross margin

 

     For the Year Ended May 31,     Change
Amount
 
     2008     2007    
     Amount    Margin %     Amount     Margin %    
     (in ‘000)          (in ‘000)           (in ‘000)  

Traditional reagents

   $ 139,428    78   $ 121,666      76   $ 17,762   

Capture products

     45,568    85     35,822      84     9,746   

Instruments

     476    2     (549   -3     1,025   

Collagen

     17    1     816      20     (799
                           
   $ 185,489    71   $ 157,755      71   $ 27,734   
                           

 

     The determination of gross margin is exclusive of amortization expense which is presented separately as an operating expense in the income statement.

Though there were small improvements in gross margin percentages in all categories except collagen in fiscal 2008, the same overall gross margin of 71% was achieved in fiscal 2008 and fiscal 2007, due to a change in the sales mix. In the case of instruments, comparing gross margin from period to period can be misleading because of the way revenue and cost for certain types of instrument sales are recorded. Where sales contracts have price guarantee clauses, instrument costs are expensed when the sale is made, but the related revenue is deferred and recorded as income over the term of the agreement. For fiscal 2008, the gross margin on instruments was 2% and, for fiscal 2007, it was a negative 3%. In fiscal 2008, we deferred $5.6 million more revenue ($17.5 million in fiscal 2008; $11.9 million in fiscal 2007) from sales of instruments and recognized $4.9 million more revenue ($13.3 million in fiscal 2008; $8.4 million in fiscal 2007) compared to fiscal 2007.

Operating expenses

 

     For the Year Ended May 31,    Change
             2008                    2007            Amount     %
     ($ in thousands)      

Research and development

   $ 6,454    $ 6,354    $ 100      2%

Selling and marketing

     32,970      26,595      6,375      24%

Distribution

     11,394      9,635      1,759      18%

General and administrative

     25,925      22,162      3,763      17%

Restructuring expense

     646      1,051      (405   -39%

Amortization expense and other

     357      346      11      3%
                        

Total operating expenses

   $ 77,746    $ 66,143    $ 11,603      18%
                        

An increase in selling and marketing expenses of $6.4 million to $33.0 million, or 24%, over the prior fiscal year was largely due to an increase in salaries and commissions of $2.6 million, one-time severance expense of $1.0 million incurred for the reorganization of the sales and marketing resources in Europe and expenses of the new affiliate in France of $0.5 million. We increased our sales staff in preparation of the launch of the Echo and also to more aggressively market the Galileo. This accounted for a major portion of the increase in the personnel cost in fiscal 2008. The impact of the weakening of the U.S. Dollar against the Euro by about 10% in fiscal 2008 accounted for an increase of approximately $1.4 million in selling and marketing expenses of the European affiliates.

An increase in distribution expenses of $1.8 million, or 18%, in fiscal 2008 over fiscal 2007 was mainly due to an increase in freight expenses of $0.6 million as a result of increased shipments of instruments and setup costs for centralization of European operations in Germany, and an increase in salaries of $0.3 million. The impact of the weakening of the U.S. Dollar against the Euro by about 10% in fiscal 2008 accounted for approximately $0.4 million increase in distribution expenses of the European affiliates.

 

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General and administrative expenses rose by $3.8 million, or 17%, in fiscal 2008 over fiscal 2007, largely due to an increase in personnel costs in the U.S. of $2.2 million, offset by a reduction in professional fees of $0.6 million. The new French affiliate accounted for $0.9 million of the increase and the impact of the weakening of the U.S. Dollar against the Euro by about 10% in fiscal 2008 accounted for approximately $0.8 million increase in general and administrative expenses of the European affiliates.

We consolidated our manufacturing operations in Norcross, Georgia and closed the Houston plant in December 2007. In fiscal 2008, this action resulted in restructuring charges of $0.6 million, approximately $2.1 for production consolidation and $0.2 million for relocation expenses, offset by a $1.7 million gain on the sale of the Houston property. In fiscal 2007, we spent $1.1 million on the Houston closure: approximately $0.5 million for production consolidation, $0.3 million for retention bonuses and $0.3 million for relocation expenses. The total cost of restructuring was $4.4 million, of which $2.7 million was incurred in fiscal 2006, including a charge of $2.3 million for the impairment of the Houston property.

Non-operating income

 

     For the Year Ended May 31,    Change
Amount
             2008                    2007           
     ($ in thousands)

Non-operating income

   $ 3,925    $ 2,542    $ 1,383
                    

In fiscal 2008, we earned $1.4 million more interest income compared to fiscal 2007 due to the increase in our cash resources by $61.5 million.

Income taxes

The provision for income taxes increased $6.1 million in fiscal 2008 from the prior year, primarily due to higher pre-tax income with the overall effective tax rate remaining unchanged at 36% for fiscal 2008. Net deferred tax assets increased by $5.6 million mainly due to an increase of $3.2 million as a result of the adoption of FIN 48 in fiscal 2008 and an increase of $1.1 million in share-based compensation.

As a result of using compensation cost deductions arising from the exercise of nonqualified employee stock options for federal and state income tax purposes, we realized income tax benefits of approximately $7.5 million in fiscal 2008 and $12.3 million in fiscal 2007. As required by U.S. generally accepted accounting principles, these income tax benefits are recognized in our financial statements as additions to additional paid-in capital rather than as reductions of the respective income tax provisions in the consolidated financial statements because the related compensation deductions are not recognized as compensation expense for financial reporting purposes. Our income tax liability is reduced by these amounts.

 

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Liquidity and Capital Resources

Cash flow

Our principal source of liquidity is our operating cash flow. This cash-generating capability is one of our fundamental strengths and provides us with substantial financial flexibility in meeting our operating, investing and financing needs. We have adequate working capital and sources of capital to operate our current business and to meet our existing capital requirements. At May 31, 2009, we had working capital of $192.6 million, compared to $230.6 million of working capital at May 31, 2008. The following table shows the cash flows provided by or used in operating, investing and financing activities for fiscal years 2009, 2008 and 2007, as well as the effect of exchange rates on cash and cash equivalents for those same years:

 

     For the Year Ended May 31,  
     2009     2008     2007  
     (in thousands)  

Net cash provided by operating activities

   $ 79,822      $ 75,105      $ 58,279   

Net cash used in investing activities

     (116,556     (15,693     (9,245

Cash provided by (used in) financing activities

     (1,396     72        10,175   

Effect of exchange rate changes on cash and cash equivalents

     (465     2,021        239   
                        

Increase (decrease) in cash and cash equivalents

   $ (38,595   $ 61,505      $ 59,448   
                        

Our cash and cash equivalents were $136.5 million as of May 31, 2009, as compared to $175.1 million as of May 31, 2008. The decrease in our cash position was primarily due to net cash payments of $108.0 million for the acquisitions of BioArray and our U.K. distributor.

Operating activities—In fiscal 2009, net cash generated by operating activities was $79.8 million compared with $75.1 million in fiscal 2008. The year-over-year increase in cash flow from operating activities was primarily attributable to the $4.7 million year-over-year increase in net income.

In fiscal 2008, net cash generated by operating activities was $75.1 million, as compared with $58.3 million generated in fiscal 2007. The year-over-year increase in cash flow was attributable to the year-over-year increase in net income of $11.4 million and a reduction in an adjustment of approximately $4.8 million for the tax benefit arising on exercise of stock options, which is required to be disclosed as cash generated by financing activities since our adoption of SFAS 123(R) effective June 1, 2006.

In fiscal 2007, net cash generated by operating activities was $58.3 million and was primarily attributable to net income of $60.1 million.

Investing activities—For fiscal 2009, $116.6 million of net cash was used in investing activities compared with $15.7 million of cash used in the fiscal 2008. We paid $108.0 million for the acquisition of BioArray and our U.K. distributor in fiscal 2009. For the purchase of property and equipment, we spent $8.6 million in the fiscal 2009 compared with $11.6 million spent in fiscal 2008.

In fiscal 2008, $15.7 million of cash was used in investing activities, for capital expenditures ($11.6 million), for an advance payment of $4.4 million for the acquisition of our U.K. distributor, for reacquired distribution rights for France ($1.0 million), for capitalized costs relating to the proposed acquisition of BioArray ($0.7 million) offset by $2.0 million received from the sale of our Houston plant.

In fiscal 2007, $9.2 million of cash was used in investing activities, primarily for capital expenditures ($10.9 million), partly offset by proceeds of $1.6 million received from the sale of short-term investments.

Financing activities—In fiscal 2009, net cash used in financing activities was $1.4 million compared with net cash generated by financing activities of $0.1 million in the prior year. During fiscal 2009, we used $6.7

 

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million to repurchase shares of our common stock in the open market. Also reflected in ‘repurchase of common stock’ in the cash flow statement is approximately $1.0 million in withholding taxes we paid. This payment was in compliance with statutory tax withholding requirements for the exercise of options and vesting of restricted shares in exchange for surrender of the Company’s shares of equal value. We received $3.2 million and $2.7 million from the exercise of employee stock options in the fiscal 2009 and fiscal 2008, respectively. We received $3.3 million and $7.5 million of excess tax benefits from share-based compensation for the fiscal 2009 and fiscal 2008, respectively.

Net cash provided by financing activities was $0.1 million in fiscal 2008, compared with $10.2 million in fiscal 2007. During fiscal 2008, we had a cash outflow of $5.5 million for payment of withholding taxes in compliance with the statutory tax withholding requirements on exercise of options and vesting of restricted shares in exchange for surrender of the Company’s shares of equal value. The value of these reacquired shares is disclosed as ‘Repurchase of common stock’ under financing activities in the consolidated statement of cash flows. In fiscal 2008, we did not repurchase any shares in the open market under our stock repurchase program, compared to the $4.9 million used for this purpose in fiscal 2007. We had a cash outlay of $4.7 million and $1.1 million in fiscal 2008 and fiscal 2007, respectively, to pay our acquisition liability for the purchase of our Japanese distribution business from Kainos. At the end of fiscal 2008, we concluded the three-year transition arrangement with Kainos related to that purchase and paid Kainos all the remaining amounts due. We received $2.7 million and $3.9 million from the exercise of employee stock options in fiscal 2008 and 2007, respectively. We received $7.5 million and $12.3 million of excess tax benefits from share-based compensation as cash provided by financing activities in fiscal 2008 and fiscal 2007, respectively.

Stock Repurchase Program

During the fiscal year ended May 31, 2009, we repurchased 295,409 shares of our common stock under our stock repurchase program for approximately $6.7 million at an average per share price of $22.52. We made no share repurchases during fiscal 2008. In fiscal 2007, we spent $4.9 million to repurchase 281,969 shares under this program. Since the introduction of the plan in 1998, we have repurchased 8,528,353 shares of our common stock having an aggregate value of approximately $57.6 million. As of May 31, 2009, 846,647 shares were available for repurchase under the program.

Contingencies

We record contingent liabilities resulting from asserted and unasserted claims against us when it is probable that a liability has been incurred and the amount of the loss is reasonably estimable. We disclose contingent liabilities when there is a reasonable possibility that the ultimate loss will exceed the recorded liability. Estimating probable losses requires analysis of multiple factors, in some cases including judgments about the potential actions of third-party claimants and courts. Therefore, actual losses in any future period are inherently uncertain. While we are currently involved in certain legal proceedings, we do not believe these proceedings will have a material adverse effect on our consolidated financial position. It is possible, however, that future results of operations for any particular quarterly or annual period could be materially affected by changes in our assumptions or the effectiveness of our strategies related to these proceedings. Contingent liabilities are described in Note 18 to the consolidated financial statements.

Future Cash Requirements and Restrictions

We expect that cash and cash equivalents and cash flows from operations will be sufficient to support our operations and planned capital expenditures for at least the next 12 months. We expect to continue to generate net positive cash flow. In the longer term, we will be able to use a portion of BioArray’s net operating tax loss carryforwards, subject to certain conditions and limitations, which will positively impact cash flows. Planned capital expenditures for fiscal 2010 are approximately $10 to $12 million. Additionally, we expect to deploy our

 

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cash to finance the rental of instruments, primarily in the U.S. In accordance with U.S. GAAP, this activity will be reflected in working capital in our statement of cash flows. There are no restrictions on our subsidiaries with respect to sending dividends, or making loans or advances to Immucor.

Contractual Obligations and Commercial Commitments

Contractual obligations and commercial commitments, primarily for the next five years, are detailed in the table below:

 

      Payments Due by Period
(in thousands)

Contractual Obligations

   Total    Less than 1 year    1 - 3 years    4 - 5 years    After 5 years

Operating leases

   $ 15,952    $ 2,887    $ 5,090    $ 4,470    $ 3,505

Purchase obligations

     19,481      19,410      71      —        —  
                                  

Total contractual cash obligations

   $ 35,433    $ 22,297    $ 5,161    $ 4,470    $ 3,505
                                  

In addition to the obligations in the table above, approximately $10.8 million of unrecognized tax benefits have been recorded as liabilities in accordance with FIN 48, and we are uncertain as to if or when such amounts may be settled. Related to the unrecognized tax benefits not included in the table above, we have also recorded a liability for interest of $1.5 million.

Off-Balance Sheet Arrangements

We have no off-balance sheet financial arrangements as of May 31, 2009.

Critical Accounting Policies and Estimates

General

We have identified the policies below as critical to our business operations and the understanding of our results of operations. The impact and any associated risks related to these policies on our business operations are discussed throughout Management’s Discussion and Analysis of Financial Condition and Results of Operations where such policies affect our reported and expected financial results. For a detailed discussion on the application of these and other accounting policies, see Note 1 to the consolidated financial statements in Item 8 of this Annual Report on Form 10-K. Note that our preparation of this Annual Report on Form 10-K requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of our financial statements, and the reported amounts of revenue and expenses during the reporting period. Actual results could differ from those estimates, and certain assumptions could prove to be incorrect. Senior management has discussed the development and selection of critical accounting estimates and the related Management’s Discussion and Analysis of Financial Condition and Results of Operations disclosure with the Audit Committee of our Board of Directors. We believe that our most critical accounting policies and estimates relate to the following:

 

  i. Revenue recognition

 

  ii. Trade accounts receivable and allowance for doubtful accounts

 

  iii. Inventory

 

  iv. Goodwill

 

  v. Taxation

 

  vi. Stock-based compensation

 

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i) Revenue Recognition

In accordance with the Staff Accounting Bulletin No. 104, Revenue Recognition, guidance, we recognize revenue when the following four basic criteria have been met: (1) persuasive evidence of an arrangement exists; (2) delivery has occurred or services rendered; (3) the fee is fixed and determinable; and (4) collectibility is reasonably assured. Should changes in conditions cause management to determine these criteria are not met for certain future transactions, revenue recognized for any reporting period could be adversely affected.

 

   

Reagent sales

Revenue from the sale of our reagents to end users is primarily recognized upon shipment when both title and risk of loss transfer to the customer, unless there are specific contractual terms to the contrary. Revenue from the sale of our reagents to distributors is recognized FOB customs clearance when both title and risk of loss transfer to the customer.

 

   

Medical instrument sales

Revenue from the sale of our medical instruments without multiple deliverables is generally recognized upon shipment and completion of contractual obligations. Revenue from rentals of our medical instruments is recognized over the term of the rental agreement. Instrument service contract revenue is recognized over the term of the service contract.

In cases of sales or rentals of instruments with multiple deliverables, we recognize revenue on the sale of medical instruments in accordance with Emerging Issues Task Force (“EITF”) Issue No. 00-21, Accounting for Revenue Arrangements with Multiple Deliverables. Our medical instrument sales contracts with multiple deliverables include the sale or rental of an instrument (including delivery, installation and training), the servicing of the instrument during the first year, and, in many cases, price guarantees for reagents and consumables purchased during the contract period. We have determined the fair value of certain of these elements, such as training and first year service. If the agreement does not include any price guarantees, the sales price in excess of the fair values of training and service is allocated to the instrument itself and recognized upon shipment and completion of contractual obligations relating to training and/or installation. The fair value of a training session is recognized as revenue when services are provided. The fair value of first year service is recognized over the first year of the contract. If the agreement contains price guarantees, the entire arrangement consideration is deferred and recognized over the related guarantee period due to the fair value of the price guarantee not being determinable at the point of sale. The allocation of the total consideration, which is based on the estimated fair value of the units of accounting, requires judgment by management.

ii) Trade Accounts Receivable and Allowance for Doubtful Accounts

Trade receivables at May 31, 2009, totaling $57.0 million, and at May 31, 2008, totaling $52.7 million, are net of allowances for doubtful accounts of $2.2 million and $2.0 million, respectively. The allowance for doubtful accounts represents a reserve for estimated losses resulting from the inability of our customers to pay their debts. The collectibility of trade receivable balances is regularly evaluated based on a combination of factors such as customer credit-worthiness, past transaction history with the customer, current economic industry trends and changes in customer payment patterns. If it is determined that a customer will be unable to fully meet its financial obligation, such as in the case of a bankruptcy filing or other material events impacting its business, a specific allowance for doubtful accounts is recorded to reduce the related receivable to the amount expected to be recovered.

iii) Inventory

Inventories are stated at the lower of cost (first-in, first-out basis) or market (net realizable value). Cost includes material, labor and manufacturing overhead. The Company also allocates certain general and

 

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administrative costs to inventory and incurred approximately $3.0 million, $3.9 million and $3.2 million of such costs in fiscal 2009, 2008 and 2007, respectively. The Company had approximately $1.1 million and $1.4 million of general and administrative costs remaining in inventory as of May 31, 2009 and May 31, 2008, respectively.

We use a standard cost system as a tool to monitor production efficiency. The standard cost system applies estimated labor and manufacturing overhead factors to inventory based on budgeted production and efficiency levels, staffing levels and costs of operation, based on the experience and judgment of management. Actual costs and production levels may vary from the standard established and such variances are charged to the consolidated statement of income as a component of cost of sales. Since U.S. generally accepted accounting principles require that the standard cost approximate actual cost, periodic adjustments are made to the standard rates to approximate actual costs. No material changes have been made to the inventory policy during fiscal 2009, 2008, or 2007.

iv) Goodwill

On adoption of SFAS No. 142, Goodwill and Other Intangible Assets, goodwill and intangible assets with indefinite lives are no longer amortized but are tested for impairment annually or more frequently if impairment indicators arise. Intangible assets that have finite lives are continuing to be amortized over their useful lives.

We evaluate the carrying value of goodwill at the end of the third quarter of each year and between annual evaluations if events occur or circumstances change that would more likely than not reduce the fair value of the reporting unit below its carrying amount. Such circumstances could include, but are not limited to: (1) a significant adverse change in legal factors or in business climate, (2) unanticipated competition, or (3) an adverse action or assessment by a regulator. When evaluating whether goodwill is impaired, we compare the fair value of the reporting unit to which the goodwill is assigned to the reporting unit’s carrying amount, including goodwill. The fair value of the reporting unit is estimated using primarily the income, or discounted cash flows, approach. If the carrying amount of a reporting unit exceeds its fair value, then the amount of the impairment loss must be measured. The impairment loss would be calculated by comparing the implied fair value of the reporting unit’s goodwill to its carrying amount. In calculating the implied fair value of the reporting unit’s goodwill, the fair value of the reporting unit is allocated to all of the other assets and liabilities of that unit based on their fair values. The excess of the fair value of a reporting unit over the amount assigned to its other assets and liabilities is the implied fair value of goodwill. An impairment loss would be recognized when the carrying amount of goodwill exceeds its implied fair value. Our evaluation of goodwill completed during the year resulted in no impairment charges.

v) Income Taxes

Our income tax policy records the estimated future tax effects of temporary differences between the tax bases of assets and liabilities and amounts reported in the accompanying consolidated balance sheets, as well as operating loss and tax credit carry-forwards. The value of our deferred tax assets assumes that we will be able to generate sufficient future taxable income in certain tax jurisdictions, based on estimates and assumptions. If these estimates and related assumptions change in the future, we may be required to record additional valuation allowances against our deferred tax assets resulting in additional income tax expense in our consolidated statements of income. In assessing the realizability of deferred tax assets, we consider whether it is more likely than not that some portion or all of the deferred tax assets will not be realized, and we consider the scheduled reversal of deferred tax liabilities, projected future taxable income, carry-back opportunities, and tax-planning strategies in making this assessment. We assess the need for additional valuation allowances quarterly. See Note 14 to the consolidated financial statements.

The calculation of tax liabilities involves significant judgment in estimating the impact of uncertainties in the application of complex tax laws. Although FIN 48, which we adopted at the beginning of fiscal 2008, provides further clarification on the accounting for uncertainty in income taxes recognized in the financial

 

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statements, the new threshold and measurement attribute prescribed by the FASB will continue to require significant judgment by management. Resolution of these uncertainties in a manner inconsistent with our expectations could have a material impact on our results of operations.

vi) Stock-based Employee Compensation

In December 2004, the Financial Accounting Standards Board revised Statement of Financial Accounting Standards No. 123, “Accounting for Stock-Based Compensation” (“SFAS 123(R)”), requiring companies to record share-based payments to employees as compensation expense at the grant date fair value. We adopted SFAS 123(R) on June 1, 2006, using the modified prospective transition method, which requires that (i) compensation costs be recorded as earned for all unvested stock options outstanding at the beginning of the first fiscal year of adoption of SFAS 123(R) based on the grant date fair value estimated in accordance with the original provisions of SFAS 123, and (ii) compensation costs for all share-based payments granted or modified subsequent to the adoption be recorded, based on the grant date fair value estimated in accordance with the provisions of SFAS 123(R). In accordance with the modified prospective transition method, we have not restated the financial statements for prior periods and those statements do not include the impact of SFAS 123(R). In conjunction with the adoption of SFAS 123(R), we elected to attribute the value of share-based compensation to expense using the straight-line method, which was previously used for disclosing our pro forma information required under SFAS 123.

Prior to adopting SFAS 123(R), we presented all tax benefits resulting from the exercise of stock options as operating cash flows in the consolidated statement of cash flows. SFAS 123(R) requires cash flows resulting from excess tax benefits to be classified as a part of cash flows from financing activities. Excess tax benefits are realized tax benefits from tax deductions for exercised options in excess of the deferred tax asset attributable to stock compensation costs for such options.

We elected to value our share-based payment awards using the Black-Scholes option-pricing model (the “Black-Scholes model”), which was previously used for disclosing our pro forma information required under SFAS 123 for fiscal year 2006. The Black-Scholes model was developed for use in estimating the fair value of traded options that have no vesting restrictions and are fully transferable. The Black-Scholes model requires the input of certain assumptions. Our stock options have characteristics significantly different from those of traded options, and changes in the assumptions can materially affect the fair value estimates. See Note 12 of the notes to the consolidated financial statements for a detailed discussion of SFAS 123(R).

We have calculated our additional paid in capital pool (“APIC pool”) based on the actual income tax benefits received from exercises of stock options granted after the effective date of SFAS 123 using the long method. The APIC pool is available to absorb any tax deficiencies subsequent to the adoption of SFAS 123(R).

The adoption of Statement No. 123(R)’s fair value method negatively impacts our results of operations. The future impact of adoption of Statement No. 123(R) will depend on the level of share-based payments granted in the future, expected volatilities and expected useful lives, among other factors, present at the grant date. As of June 1, 2006, the unrecognized compensation expense associated with the remaining portion of the unvested outstanding awards was $4.5 million ($2.9 million, net of tax).

Recently Issued Accounting Standards

Adopted by the Company in fiscal 2009

In September 2006, the Financial Accounting Standards Board (“FASB”) issued SFAS No. 157, “Fair Value Measurements” (“SFAS No. 157”). SFAS No. 157 provides guidance for using fair value to measure assets and liabilities. This standard also responds to investors’ requests for expanded information about the extent to which companies measure assets and liabilities at fair value, the information used to measure fair value and the effect of

 

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fair value measurements on earnings. SFAS No. 157 applies whenever other standards require (or permit) assets or liabilities to be measured at fair value. The standard does not expand the use of fair value in any new circumstances. For financial assets and liabilities, SFAS No. 157 is effective for fiscal years beginning after November 15, 2007. The Company adopted the provisions for the financial assets and liabilities in fiscal 2009 and adoption did not have a material impact on the Company’s results of operations or financial position. For nonfinancial assets and liabilities, SFAS No. 157 is effective for fiscal years beginning after November 15, 2008, which will require the Company to adopt these provisions in fiscal 2010. The Company does not believe SFAS No. 157’s provisions for nonfinancial assets and liabilities will have a material impact on its results of operations or financial position.

In February 2008, the FASB issued FASB Staff Position FAS 157-1, “Application of FASB Statement No. 157 to FASB Statement No. 13 and Other Accounting Pronouncements that Address Fair Value Measurements for Purposes of Lease Classification or Measurement under Statement 13,” (“FSP FAS 157-1”) This FSP excludes certain leasing transactions accounted for under FASB Statement No. 13, “Accounting for Leases,” from the scope of SFAS No. 157. The exclusion does not apply to fair value measurements of assets and liabilities recorded as a result of a lease transaction but measured pursuant to other pronouncements within the scope of Statement 157. FSP FAS 157-1 is effective upon the initial adoption of Statement 157. The adoption of FSP FAS 157-1 did not have a material impact on its results of operation or financial position of the Company.

In October 2008, the FASB issued FASB Staff Position No. FAS 157-3, Determining the Fair Value of a Financial Asset when the Market for That Asset Is Not Active (“FSP FAS 157-3”). FSP FAS 157-3 provides guidance on calculating fair value in an inactive market. This FSP is effective upon issuance, including prior periods for which financial statements have not been issued. The adoption of this FSP did not have an impact on our consolidated financial statements.

In February 2007, the FASB issued SFAS No. 159, “The Fair Value Option for Financial Assets and Financial Liabilities,” (“SFAS No. 159”) which gives entities the option to measure eligible financial assets, financial liabilities and firm commitments at fair value (i.e., the fair value option), on an instrument-by-instrument basis, that are otherwise not permitted to be accounted for at fair value under other accounting standards. The election to use the fair value option is available when an entity first recognizes a financial asset or financial liability or upon entering into a firm commitment. Subsequent changes in fair value must be recorded in earnings. SFAS No. 159 was adopted by the Company in its fiscal year beginning June 1, 2008. The adoption of SFAS No. 159 did not have a material impact on the Company’s results of operations or financial position as the Company did not elect to record any applicable amounts at fair value.

In June 2007, the Emerging Issues Task Force (“EITF”) issued EITF 07-3, “Accounting for Nonrefundable Advance Payments for Goods or Services to Be Used in Future Research and Development Activities” (“EITF 07-3”). EITF 07-3 addresses the diversity that exists with respect to accounting for the non-refundable portion of a payment made by a research and development entity for future research and development activities. The EITF concluded that an entity must defer and capitalize non-refundable advance payments made for research and development activities until the related goods are delivered or the related services are performed. Entities should continue to evaluate whether they expect the goods to be delivered or services to be rendered. If an entity does not expect the goods to be delivered or services to be rendered, the capitalized advance payment should be charged to expense. EITF 07-3 was effective for the Company in its fiscal year beginning June 1, 2008. The adoption of EITF 07-3 did not have a material impact on the Company’s results of operations or financial position.

In December 2007, the SEC issued Staff Accounting Bulletin No. 110, “Use of a Simplified Method in Developing Expected Term of Share Options” (“SAB 110”). SAB 110 expresses the current view of the staff that it will accept a company’s election to use the simplified method discussed in SAB 107 for estimating the expected term of “plain vanilla” share options regardless of whether the company has sufficient information to

 

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make more refined estimates. As permitted by SAB 110, the Company continues to use the simplified method as the Company does not have sufficient historical data for options with six-year contractual terms to estimate the expected term of share based awards.

In May 2008, the FASB issued Statement No. 162, “Hierarchy of Generally Accepted Accounting Principles”, which simply moves the requirements related to which authoritative literature to look to first from the audit standards to GAAP. SFAS 162 was effective on November 15, 2008. The adoption of SFAS 162 did not have a material effect on its consolidated financial statements.

Not yet adopted by the Company

In December 2007, the FASB issued SFAS No. 141(R), “Business Combinations” (“SFAS 141(R)”). SFAS 141(R) will significantly change the financial accounting and reporting of business combination transactions. SFAS 141(R) establishes principles for how an acquirer recognizes and measures the identifiable assets acquired, liabilities assumed, and any noncontrolling interest in the acquiree; recognizes and measures the goodwill acquired in the business combination or a gain from a bargain purchase; and determines what information to disclose to enable users of the financial statements to evaluate the nature and financial effects of the business combination. SFAS 141(R) is effective for acquisition dates on or after the beginning of an entity’s first year that begins after December 15, 2008. The Company will apply the provisions of SFAS No. 141(R) to any business combination occurring on or after June 1, 2009, as required. The Company does not expect the adoption of SFAS No. 141(R) to have a material impact on its consolidated financial statements.

In December 2007, the FASB issued SFAS No. 160, “Non-controlling Interests in Consolidated Financial Statements, an Amendment of ARB No. 51” (“FASB No. 160”). This statement establishes accounting and reporting standards for the non-controlling interest in a subsidiary and for the deconsolidation of a subsidiary. This statement is effective for fiscal years beginning on or after December 15, 2008. The Company does not expect the adoption of SFAS 160 to have a material effect on its consolidated financial statements.

In April 2008, the FASB posted FASB Staff Position No. FAS 142-3, Determination of the Useful Life of Intangible Assets (“FSP FAS 142-3”), which applies to recognized intangible assets that are accounted for pursuant to SFAS No. 142, Goodwill and Other Intangible Assets. FSP FAS 142-3 amends the factors an entity must consider when developing renewal or extension assumptions used in determining the useful life of a recognized intangible asset. It also requires entities to provide certain disclosures about its assumptions. FSP FAS 142-3 is effective for financial statements issued for fiscal years beginning after December 15, 2008 and interim periods within those fiscal years. The Company is currently evaluating the impact of the adoption of these requirements on its financial statements.

In June 2008, the FASB issued FASB Staff Position EITF 03-6-1, Determining Whether Instruments Granted in Share-Based Payment Transactions Are Participating Securities (“FSP EITF 03-6-1”). Under the FSP, unvested share-based payment awards that contain rights to receive nonforfeitable dividends (whether paid or unpaid) are participating securities, and should be included in the two-class method of computing EPS. The FSP is effective for fiscal years beginning after December 15, 2008, and interim periods within those years. The Company does not expect the adoption of FSP EITF 03-6-1 to have a material effect on its consolidated financial statements.

In May 2009, the FASB issued SFAS No. 165, “Subsequent Events” (“SFAS 165”). SFAS 165 establishes general standards of accounting for and disclosure of events that occur after the balance sheet date but before financial statements are issued. The effective date of SFAS 165 is interim or annual financial periods ending after June 15, 2009. The Company does not expect that the adoption of SFAS 165 will have a material effect on its consolidated financial statements.

This statement does not apply to subsequent events or transactions that are within the scope of other applicable generally accepted accounting principles that provide different guidance on the accounting treatment

 

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for subsequent events or transactions. SFAS No. 165 would apply to both interim financial statements and annual financial statements and should not result in significant changes in the subsequent events that are reported. SFAS No. 165 introduces the concept of financial statements being available to be issued. It requires the disclosure of the date through which a Company has evaluated subsequent events and the basis for that date, whether that represents the date the financial statements were issued or were available to be issued. SFAS No. 165 should alert all users of financial statements that an entity has not evaluated subsequent events after that date in the set of financial statements being presented. This statement is effective for interim or annual reporting periods ending after June 15, 2009, which corresponds to the Company’s first quarter of fiscal year 2010.

In June 2009, the FASB issued SFAS No. 166 “Accounting for Transfers of Financial Assets” (“SFAS 166”). SFAS 166 is a revision to FASB Statement No. 140, Accounting for Transfers and Servicing of Financial Assets and Extinguishments of Liabilities, and will require more information about transfers of financial assets, including securitization transactions, and where entities have continuing exposure to the risks related to transferred financial assets. It eliminates the concept of a “qualifying special-purpose entity,” changes the requirements for derecognizing financial assets, and requires additional disclosures. SFAS 166 enhances information reported to users of financial statements by providing greater transparency about transfers of financial assets and an entity’s continuing involvement in transferred financial assets. SFAS 166 will be effective at the start of a reporting entity’s first fiscal year beginning after November 15, 2009, which corresponds to the Company’s first quarter of fiscal 2011. Early application is not permitted. The Company is currently evaluating the impact of adoption of SFAS 166.

In June 2009, the FASB issued SFAS No. 167 “Amendments to FASB Interpretation No. 46(R)” (“SFAS 167”). SFAS 167 is a revision to FASB Interpretation No. 46 (Revised December 2003), Consolidation of Variable Interest Entities, and changes how a reporting entity determines when an entity that is insufficiently capitalized or is not controlled through voting (or similar rights) should be consolidated. The determination of whether a reporting entity is required to consolidate another entity is based on, among other things, the other entity’s purpose and design and the reporting entity’s ability to direct the activities of the other entity that most significantly impact the other entity’s economic performance. SFAS 167 will require a reporting entity to provide additional disclosures about its involvement with variable interest entities and any significant changes in risk exposure due to that involvement. A reporting entity will be required to disclose how its involvement with a variable interest entity affects the reporting entity’s financial statements. SFAS 167 will be effective at the start of a reporting entity’s first fiscal year beginning after November 15, 2009. Early application is not permitted. The Company is currently evaluating the impact, if any, of adoption of SFAS 167 on its financial statements.

In June 2009, the FASB issued SFAS No. 168 “The FASB Accounting Standards Codification and the Hierarchy of Generally Accepted Accounting Principles – A Replacement of FASB Statement No. 162” (“SFAS 168”). SFAS 168 establishes the FASB Accounting Standards CodificationTM (Codification) as the single source of authoritative U.S. generally accepted accounting principles (U.S. GAAP) recognized by the FASB to be applied by nongovernmental entities. Rules and interpretive releases of the SEC under authority of federal securities laws are also sources of authoritative U.S. GAAP for SEC registrants. SFAS 168 and the Codification are effective for financial statements issued for interim and annual periods ending after September 15, 2009, which corresponds to the Company’s second quarter of fiscal 2010. When effective, the Codification will supersede all existing non-SEC accounting and reporting standards. All other nongrandfathered non-SEC accounting literature not included in the Codification will become nonauthoritative. Following SFAS 168, the FASB will not issue new standards in the form of Statements, FASB Staff Positions, or Emerging Issues Task Force Abstracts. Instead, the FASB will issue Accounting Standards Updates, which will serve only to: (a) update the Codification; (b) provide background information about the guidance; and (c) provide the bases for conclusions on the change(s) in the Codification. The adoption of SFAS 168 will not have an impact on the Company’s consolidated financial statements.

 

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Item 7A.—Quantitative and Qualitative Disclosures about Market Risk.

We are exposed to market risks for foreign currency exchange rates principally with the U.S. Dollar versus the Euro, Canadian Dollar, British Pound and Japanese Yen. Our financial instruments that can be affected by foreign currency fluctuations and exchange risks consist primarily of cash and cash equivalents and trade receivables denominated in currencies other than the U.S. dollar. We attempt to manage our exposure primarily by balancing assets and liabilities and maintaining cash positions in foreign currencies only at levels necessary for operating purposes. It has not been our practice to actively hedge our foreign subsidiaries’ assets or liabilities denominated in foreign currencies. To manage these risks, we regularly evaluate our exposure and, if warranted, may enter into various derivative transactions when appropriate. We do not hold or issue derivative instruments for trading or other speculative purposes. In fiscal years 2009, 2008, and 2007, we recorded foreign currency translation losses of $4.0 million in fiscal 2009 and gains of $8.6 million and $1.1 million in fiscal 2008 and 2007, respectively.

 

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Item 8.—Financial Statements and Supplementary Data.

INDEX TO CONSOLIDATED FINANCIAL STATEMENTS

 

     Page

Reports of Grant Thornton, LLP, Independent Registered Public Accounting Firm

   44

Consolidated Balance Sheets, May 31, 2009 and 2008

   46

Consolidated Statements of Income for the Year Ended May 31, 2009, 2008 and 2007

   47

Consolidated Statements of Shareholders’ Equity and Comprehensive Income for the Years Ended May  31, 2009, 2008 and 2007

   48

Consolidated Statements of Cash Flows for the Year Ended May 31, 2009, 2008 and 2007

   49

Notes to Consolidated Financial Statements

   50

Consolidated Financial Statement Schedule

   77

 

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REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

ON CONSOLIDATED FINANCIAL STATEMENTS

Board of Directors and Shareholders

Immucor, Inc.

We have audited the accompanying consolidated balance sheets of Immucor, Inc. (a Georgia corporation) and subsidiaries (the “Company”) as of May 31, 2009 and 2008, and the related consolidated statements of income, shareholders’ equity and comprehensive income, and cash flows for each of the three years in the period ended May 31, 2009. Our audits of the basic consolidated financial statements included the financial statement schedule listed in the index appearing under Item 8. These financial statements and the financial statement schedule are the responsibility of the Company’s management. Our responsibility is to express an opinion on these financial statements and financial statement schedule based on our audits.

We conducted our audits in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan and perform the audits to obtain reasonable assurance about whether the financial statements are free of material misstatement. An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements. An audit also includes assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis for our opinion.

In our opinion, the consolidated financial statements referred to above present fairly, in all material respects, the financial position of the Company as of May 31, 2009 and 2008, and the consolidated results of its operations and its cash flows for each of the three years in the period ended May 31, 2009 in conformity with accounting principles generally accepted in the United States of America. Also in our opinion, the related financial statement schedule, when considered in relation to the basic consolidated financial statements taken as a whole, presents fairly, in all material respects, the information set forth therein.

As discussed in Note 1 to the consolidated financial statements, the Company adopted the provisions of Financial Accounting Standards Board Interpretation No. 48, “Accounting for Uncertainty in Income Taxes—an interpretation of FASB Statement 109” effective June 1, 2007.

We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States), the Company’s internal control over financial reporting as of May 31, 2009, based on criteria established in Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO) and our report dated July 23, 2009 expressed an unqualified opinion thereon.

/s/ Grant Thornton LLP

Atlanta, Georgia

July 23, 2009

 

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REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

ON INTERNAL CONTROL OVER FINANCIAL REPORTING

Board of Directors and Shareholders

Immucor, Inc.

We have audited Immucor, Inc. (a Georgia corporation) and subsidiaries’ (the “Company”) internal control over financial reporting as of May 31, 2009, based on criteria established in Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO). The Company’s management is responsible for maintaining effective internal control over financial reporting and for its assessment of the effectiveness of internal control over financial reporting, included in Management’s Report on Internal Controls Over Financial Reporting appearing under Item 9A of this Annual Report on Form 10-K. Our responsibility is to express an opinion on Immucor, Inc.’s internal control over financial reporting based on our audit. Our audit of, and opinion on, Immucor, Inc.’s internal control over financial reporting does not include internal control over financial reporting of BioArray Solutions, Ltd., a wholly owned subsidiary, whose financial statements reflect total assets and revenues constituting 26 percent and 1 percent of the Company’s consolidated assets and revenues, respectively as of and for the year ended May 31, 2009. As indicated in Management’s Report, BioArray Solutions, Ltd. was acquired during the 2009 fiscal year and therefore, management’s assertion on the effectiveness of Immucor, Inc.’s internal control over financial reporting excluded internal control over financial reporting of BioArray Solutions Ltd.

We conducted our audit in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan and perform the audit to obtain reasonable assurance about whether effective internal control over financial reporting was maintained in all material respects. Our audit included obtaining an understanding of internal control over financial reporting, assessing the risk that a material weakness exists, testing and evaluating the design and operating effectiveness of internal control based on the assessed risk, and performing such other procedures as we considered necessary in the circumstances. We believe that our audit provides a reasonable basis for our opinion.

A company’s 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 company’s 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 company’s 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 Company maintained, in all material respects, effective internal control over financial reporting as of May 31, 2009, based on criteria established in Internal Control—Integrated Framework issued by COSO.

We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States), the consolidated balance sheets of the Company as of May 31, 2009 and 2008, and the related consolidated statements of income, shareholders’ equity and comprehensive income, and cash flows for each of the three years in the period ended May 31, 2009 and our report dated July 23, 2009 expressed an unqualified opinion on those financial statements.

/s/ Grant Thornton LLP

Atlanta, Georgia

July 23, 2009

 

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ITEM 1. Financial Statements

IMMUCOR, INC. AND SUBSIDIARIES

CONSOLIDATED BALANCE SHEETS

(Amounts in thousands, except per share data)

 

     May 31, 2009    May 31, 2008

ASSETS

     

CURRENT ASSETS:

     

Cash and cash equivalents

   $ 136,461    $ 175,056

Trade accounts receivable, net of allowance for doubtful accounts of $2,179 at May 31, 2009 and $2,024 at May 31, 2008

     57,017      52,720

Inventories

     38,256      32,228

Deferred income tax assets, current portion

     7,979      6,151

Prepaid expenses and other current assets

     5,137      5,420
             

Total current assets

     244,850      271,575

PROPERTY AND EQUIPMENT, Net

     43,461      36,426

GOODWILL

     97,255      36,758

INTANGIBLE ASSETS, Net

     61,355      7,497

DEFERRED INCOME TAX ASSETS

     3,638      6,996

OTHER ASSETS

     781      5,698
             

Total assets

   $ 451,340    $ 364,950
             

LIABILITIES AND SHAREHOLDERS’ EQUITY

     

CURRENT LIABILITIES:

     

Accounts payable

   $ 9,344    $ 7,546

Accrued expenses and other current liabilities

     20,253      15,715

Income taxes payable

     11,469      6,612

Deferred revenue, current portion

     11,222      11,146
             

Total current liabilities

     52,288      41,019

DEFERRED REVENUE

     10,871      13,010

DEFERRED INCOME TAX LIABILITIES

     1,272      1,031

OTHER LONG-TERM LIABILITIES

     2,331      2,194
             

Total liabilities

     66,762      57,254

COMMITMENTS AND CONTINGENCIES (Note 18)

     —        —  

SHAREHOLDERS’ EQUITY:

     

Common stock, $0.10 par value; authorized 120,000,000 shares, issued and outstanding 70,456,522 and 70,136,225 shares at May 31, 2009 and May 31, 2008, respectively

     7,046      7,014

Additional paid-in capital

     42,012      37,325

Retained earnings

     327,242      251,059

Accumulated other comprehensive income

     8,278      12,298
             

Total shareholders’ equity

     384,578      307,696
             

Total liabilities and shareholders’ equity

   $ 451,340    $ 364,950
             

The accompanying notes are an integral part of these Consolidated Financial Statements.

 

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IMMUCOR, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF INCOME

(Amounts in thousands, except per share data)

 

     For the year ended May 31,  
     2009     2008     2007  

NET SALES

   $ 300,547      $ 261,199      $ 223,678   

COST OF SALES (exclusive of amortization shown separately below)

     84,536        75,710        65,923   
                        

GROSS PROFIT

     216,011        185,489        157,755   

OPERATING EXPENSES

      

Research and development

     10,698        6,454        6,354   

Selling and marketing

     39,191        32,970        26,595   

Distribution

     13,708        11,394        9,635   

General and administrative

     31,717        25,925        22,162   

Restructuring expenses

     —          646        1,051   

Amortization expense and other

     3,739        357        346   
                        

Total operating expenses

     99,053        77,746        66,143   
                        

INCOME FROM OPERATIONS

     116,958        107,743        91,612   

NON-OPERATING INCOME (EXPENSE)

      

Interest income

     1,957        4,263        2,841   

Interest expense

     (250     (371     (432

Other, net

     (1,684     33        133   
                        

Total non-operating income

     23        3,925        2,542   
                        

INCOME BEFORE INCOME TAXES

     116,981        111,668        94,154   

PROVISION FOR INCOME TAXES

     40,798        40,214        34,086   
                        

NET INCOME

   $ 76,183      $ 71,454      $ 60,068   
                        

Earnings per share:

      

Per common share—basic

   $ 1.08      $ 1.02      $ 0.88   
                        

Per common share—diluted

   $ 1.07      $ 1.00      $ 0.85   
                        

 

The accompanying notes are an integral part of these Consolidated Financial Statements.

 

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IMMUCOR, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENT OF SHAREHOLDERS’ EQUITY AND COMPREHENSIVE INCOME

(Amounts in thousands)

 

     Common Stock     Additional
Paid-In
Capital
    Retained
Earnings
    Accumulated
Other
Comprehensive
Income
    Total
Shareholders’
Equity
 
     Shares     Amount          

BALANCE, MAY 31, 2006

   67,926      $ 6,793      $ 14,752      $ 119,700      $ 2,626      $ 143,871   

Shares issued under employee stock plan

   1,443        144        3,772        —          —          3,916   

Stock-based compensation expense

   —          —          3,123        —          —          3,123   

Stock repurchases and retirements

   (282     (28     (4,844     —          —          (4,872

Tax benefits related to stock-based compensation

   —          —          12,273        —          —          12,273   

Comprehensive income (net of taxes):

            

Foreign currency translation adjustments

   —          —          —          —          1,069        1,069   

Net income

   —          —          —          60,068        —          60,068   
                  

Total comprehensive income

               61,137   
                                              

BALANCE, MAY 31, 2007

   69,087      $ 6,909      $ 29,076      $ 179,768      $ 3,695      $ 219,448   

Adjustment on adoption of FIN 48

   —          —          —          (163     —          (163
                                              

BALANCE, JUNE 1, 2007, adjusted

   69,087      $ 6,909      $ 29,076      $ 179,605      $ 3,695      $ 219,285   

Shares issued under employee stock plan

   1,274        127        3,056        —          —          3,183   

Stock-based compensation expense

   —          —          3,678        —          —          3,678   

Stock repurchases and retirements

   (225     (22     (6,024     —          —          (6,046

Tax benefits related to stock-based compensation

   —          —          7,539        —          —          7,539   

Comprehensive income (net of taxes):

            

Foreign currency translation adjustments

   —          —          —          —          8,603        8,603   

Net income

   —          —          —          71,454        —          71,454   
                  

Total comprehensive income

               80,057   
                                              

BALANCE, MAY 31, 2008

   70,136      $ 7,014      $ 37,325      $ 251,059      $ 12,298      $ 307,696   

Shares issued under employee stock plan

   669        67        3,632        —          —          3,699   

Stock-based compensation expense

   —          —          5,904        —          —          5,904   

Stock repurchases and retirements

   (349     (35     (8,102     —          —          (8,137

Tax benefits related to stock-based compensation

   —          —          3,253        —          —          3,253   

Comprehensive income (net of taxes):

            

Foreign currency translation adjustments

   —          —          —          —          (4,020     (4,020

Net income

   —          —          —          76,183        —          76,183   
                  

Total comprehensive income

               72,163   
                                              

BALANCE, MAY 31, 2009

   70,456      $ 7,046      $ 42,012      $ 327,242      $ 8,278      $ 384,578   
                                              

The accompanying notes are an integral part of these Consolidated Financial Statements.

 

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IMMUCOR, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF CASH FLOWS

(Amounts in thousands)

 

     For the year ended May 31,  
     2009     2008     2007  

OPERATING ACTIVITIES:

      

Net income

   $ 76,183      $ 71,454      $ 60,068   

Adjustments to reconcile net income to net cash provided by operating activities:

      

Depreciation and amortization

     13,306        8,376        6,871   

Accretion of acquisition liabilities

     —          206        179   

Loss on retirement of fixed assets

     352        221        132   

Gain from sale of Houston property

     —          (1,654     —     

Provision for doubtful accounts

     848        423        364   

Share-based compensation expense

     5,904        3,678        3,123   

Deferred income taxes

     5        (1,751     (3,538

Excess tax benefits from share-based compensation

     (3,253     (7,539     (12,273

Changes in operating assets and liabilities:

      

Accounts receivable, trade

     (6,310     (1,799     (10,168

Income taxes

     7,796        2,361        13,700   

Inventories

     (4,647     (1,473     (8,315

Other assets

     (7,450     (840     (173

Accounts payable

     796        (936     2,185   

Deferred revenue

     (2,247     4,224        3,520   

Accrued expenses and other liabilities

     (1,461     154        2,604   
                        

Cash provided by operating activities

     79,822        75,105        58,279   

INVESTING ACTIVITIES:

      

Purchases of property and equipment

     (8,602     (11,573     (10,893

Proceeds from sale of property and equipment

     —          2,003        —     

Acquisition of businesses, net of cash acquired

     (107,954     —          —     

Deposit paid to acquire net assets of a company

     —          (4,432     —     

Payment for acquired distribution rights

     —          (969     —     

Payments for capitalized acquisition costs

     —          (722     —     

Proceeds from short-term investments, net

     —          —          1,648   
                        

Cash used in investing activities

     (116,556     (15,693     (9,245

FINANCING ACTIVITIES:

      

Repayments of long-term debt and capital leases

     (206     (4,652     (1,092

Repurchase of common stock

     (7,621     (5,549     (4,872

Proceeds from exercise of stock options

     3,178        2,734        3,866   

Excess tax benefits from share-based compensation

     3,253        7,539        12,273   
                        

Cash provided by (used in) financing activities

     (1,396     72        10,175   

EFFECT OF EXCHANGE RATES ON CASH AND CASH EQUIVALENTS

     (465     2,021        239   
                        

INCREASE IN CASH AND CASH EQUIVALENTS

     (38,595     61,505        59,448   

CASH AND CASH EQUIVALENTS AT BEGINNING OF YEAR

     175,056        113,551        54,103   
                        

CASH AND CASH EQUIVALENTS AT END OF YEAR

   $ 136,461      $ 175,056      $ 113,551   
                        

SUPPLEMENTAL INFORMATION:

      

Tax paid

   $ 32,528      $ 39,594      $ 23,235   

Interest paid

   $ 36      $ 138      $ 225   

NON-CASH INVESTING AND FINANCING ACTIVITIES:

      

Shares surrendered for amounts due on stock options exercised

   $ 516      $ 497      $ —     

Movement from operating to investing for instruments placed on rental agreements

   $ 6,707      $ 1,993      $ 684   

The accompanying notes are an integral part of these Consolidated Financial Statements.

 

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IMMUCOR, INC. AND SUBSIDIARIES

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

 

1. NATURE OF BUSINESS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

Nature of Business—Founded in 1982, Immucor, Inc., a Georgia corporation (“Immucor” or the “Company”), develops, manufactures and sells a complete line of reagents and automated systems used primarily by hospitals, clinical laboratories and donor centers in a number of tests performed to detect and identify certain properties of the cell and serum components of human blood used for the purpose of blood transfusion. The Company operates facilities in the U.S., Canada, Europe and Japan. The Company continues to place increasing emphasis on the development and sale of instruments and instrument systems that use the Company’s proprietary reagents, while also promoting increased sales of its traditional reagent product line.

Consolidation Policy—The consolidated financial statements include the accounts of the Company and all its subsidiaries. All significant inter-company balances and transactions have been eliminated in consolidation.

Use of Estimates—The preparation of financial statements in conformity with generally accepted accounting principles in the U.S. requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Actual results could differ from those estimates.

Share-Based Compensation—The Company records share-based compensation expense in accordance with Statement of Financial Accounting Standards No. 123, “Accounting for Stock-Based Compensation” (“SFAS 123(R)”), which the Company adopted on June 1, 2006. The Company values its share-based payment awards using the Black-Scholes option-pricing model based on grant date fair value estimated in accordance with the provisions of SFAS 123(R). The expense for each share-based payment award is expensed over the vesting period of the award using the straight-line method. See Note 12 of the notes to the consolidated financial statements for a detailed discussion of SFAS 123(R).

The Company has calculated its additional paid in capital pool (“APIC pool”) based on the actual income tax benefits received from exercises of stock options granted after the effective date of SFAS 123 using the long method. The APIC pool is available to absorb any tax deficiencies subsequent to the adoption of SFAS 123(R).

Concentration of Credit Risk—Financial instruments that potentially subject the Company to concentrations of credit risk consist primarily of cash and cash equivalents and accounts receivable. In order to mitigate the concentration of credit risk, the Company places its cash and cash equivalents with multiple financial institutions. Cash and cash equivalents were $136.5 million and $175.1 million at May 31, 2009 and 2008, respectively, 82% and 88% of it located in the U.S. as of May 31, 2009 and 2008, respectively.

Concentrations of credit risk with respect to accounts receivable are limited because a large number of geographically diverse customers make up the Company’s customer base, thus spreading the trade credit risk. At May 31, 2009, and May 31, 2008, no single group or customer represents more than 10% of total accounts receivable. The Company controls credit risk through credit limits and monitoring procedures. At May 31, 2009 and 2008, the Company’s accounts receivable balances were $57.0 million and $52.7 million, respectively; about 50% of these accounts were of foreign origin, predominantly European. Companies and government agencies in some European countries require longer payment terms as a part of doing business. This may subject the Company to a higher risk of uncollectiblity. This risk is considered when the allowance for doubtful accounts is evaluated. The Company generally does not require collateral from its customers.

Factoring of accounts receivable is an additional method used by the Company’s Italian subsidiary to mitigate the risk of uncollectibility for certain customers who routinely take longer than one year to pay. The Company has agreements with certain factoring companies to sell some of its trade receivables in non-recourse transactions. The trade receivables are sold at a discount plus administrative and other fees. Sales of trade

 

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receivables are reflected as a reduction of accounts receivable in the accompanying consolidated balance sheets. The proceeds are included as operating activities in the consolidated statements of cash flows. The factoring companies retain a certain percentage of the collectible amount and these amounts are disclosed as ‘prepaid expenses and other current assets’ in the consolidated balance sheets. The outstanding retention amounts were $0.1 million and $0.4 million May 31, 2009 and 2008, respectively. The factoring fee amounted to approximately $25,000, $41,600 and $87,500 for fiscal 2009, 2008 and 2007, respectively.

Concentration of Production Facilities and Supplies—Substantially all of the Company’s reagent products are produced in its Norcross, Georgia facility in the U.S., and its reagent production is highly dependent on the uninterrupted and efficient operation of this facility. Therefore, if a catastrophic event occurred at the Norcross facility, such as a fire or tornado or if there is a production disruption for an extended period for any other reason, many of those products could not be produced until the manufacturing portion of the facility is restored and cleared by the FDA. The Company maintains a disaster plan to minimize the effects of such a catastrophe, and the Company has obtained insurance to protect against certain business interruption losses. While the Company purchases certain raw materials from a single supplier, the Company has reliable supplies of most raw materials.

Cash and Cash Equivalents—The Company considers deposits that can be redeemed on demand and investments with an original maturity of three months or less when purchased to be cash and cash equivalents. Generally, cash and cash equivalents held at financial institutions are in excess of the Federal Deposit Insurance Corporation (FDIC) insurance limit. The Company limits its exposure to credit loss by placing its cash and cash equivalents in liquid investments with high-quality financial institutions.

Inventories—Inventories are stated at the lower of cost (first-in, first-out basis) or market (net realizable value). Cost includes material, supplies, labor and manufacturing overhead. The Company also allocates certain general and administrative costs to inventory and incurred approximately $3.0 million, $3.9 million, and $3.2 million of such costs in fiscal 2009, 2008 and 2007, respectively. The Company had approximately $1.1 million and $1.4 million of general and administrative costs remaining in inventory as of May 31, 2009 and May 31, 2008, respectively.

The Company uses a standard cost system as a tool to monitor production efficiency. The standard cost system applies estimated labor and manufacturing overhead factors to inventory based on budgeted production and efficiency levels, staffing levels and costs of operation, based on the experience and judgment of management. Actual costs and production levels may vary from the standard established, and variances are charged to the consolidated statement of income as a component of cost of sales. Since U.S. generally accepted accounting principles require that the standard cost approximate actual cost, periodic adjustments are made to the standard rates to approximate actual costs. No material changes have been made to the inventory policy during fiscal 2009, 2008 or 2007.

Fair Value of Financial Instruments—The carrying amounts reported in the consolidated balance sheets for cash and cash equivalents, accounts receivable and accounts payable approximate their fair values.

In accordance with the guidance provided in SFAS No. 141, Business Combinations, in fiscal 2006 the Company recorded its liability pertaining to the acquisition of Immucor-Kainos at the estimated fair value at the time of acquisition, using a discount rate then prevailing, based on management’s estimate of the rate at which the Company would have been able to secure financing with similar terms. As permitted by Accounting Principles Board Opinion 21, the Company used the straight-line method to amortize the total imputed interest over the life of the liability as the results were not likely to be materially different from the interest method. The acquisition liability, which was recorded at fair value using a discount rate of 3.7%, the market rate for similar securities at the time of acquisition, was fully repaid prior to the year ended May 31, 2008.

 

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Property, Plant and Equipment—Property, plant and equipment is stated at cost less accumulated depreciation. Expenditures for replacements are capitalized, and the replaced items are retired. Normal maintenance and repairs are charged to operations. Major maintenance and repair activities that significantly enhance the useful life of the asset are capitalized. When property and equipment are retired, sold, or otherwise disposed of, the asset’s carrying amount and related accumulated depreciation are removed from the accounts and any gain or loss is included in operations. Depreciation is computed using the straight-line method over the estimated lives of the related assets ranging from three to thirty years. Certain internal and external costs incurred in the development of computer software for internal use are capitalized and included in property, plant and equipment in accordance with Statement of Position 98-1, Accounting for the Costs of Computer Software Developed or Obtained for Internal Use.

Goodwill—On adoption of SFAS No. 142, Goodwill and Other Intangible Assets, goodwill and intangible assets with indefinite lives are no longer amortized but are tested for impairment annually or more frequently if impairment indicators arise. Intangible assets that have finite lives are continuing to be amortized over their useful lives.

The Company evaluates the carrying value of goodwill as at the end of the third quarter of each year and between annual evaluations if events occur or circumstances change that would more likely than not reduce the fair value of the reporting unit below its carrying amount. Such circumstances could include, but are not limited to: (1) a significant adverse change in legal factors or in business climate, (2) unanticipated competition, or (3) an adverse action or assessment by a regulator. When evaluating whether goodwill is impaired, the Company compares the fair value of the reporting unit to which the goodwill is assigned to the reporting unit’s carrying amount, including goodwill. The fair value of the reporting unit is estimated using primarily the income, or discounted cash flows, approach. If the carrying amount of a reporting unit exceeds its fair value, then the amount of the impairment loss must be measured. The impairment loss would be calculated by comparing the implied fair value of the reporting unit’s goodwill to its carrying amount. In calculating the implied fair value of the reporting unit’s goodwill, the fair value of the reporting unit is allocated to all of the other assets and liabilities of that unit based on their fair values. The excess of the fair value of a reporting unit over the amount assigned to its other assets and liabilities is the implied fair value of goodwill. An impairment loss would be recognized when the carrying amount of goodwill exceeds its implied fair value. The Company’s evaluation of goodwill completed during fiscal year 2009 resulted in no impairment charges.

Deferred Licensing Costs—Deferred licensing costs with finite lives are amortized over their useful lives. In certain situations the deferred licensing costs are considered to have indefinite lives such as in the countries where the law and regulations are such that the barriers to obtaining a new license are very severe and upfront costs are high but, once the licenses are acquired, effort and costs required to maintain such licenses are minimal. The carrying values of assets with indefinite lives are not amortized but they are tested annually for impairment or more frequently if any triggering event which may impair the value of the asset occurs.

Customer Lists—Customer lists are amortized over their useful lives. Carrying values of customer lists are tested for impairment annually or more frequently if impairment indicators arise.

Net Sales Relating to Foreign Operations—Sales to customers outside the United States approximated 30% of net sales in fiscal 2009, 2008 and 2007.

Foreign Currency Translation—The financial statements of foreign subsidiaries have been translated into U.S. Dollars in accordance with SFAS No. 52, Foreign Currency Translation. The financial position and results of operations of the Company’s foreign subsidiaries are measured using the foreign subsidiary’s local currency as the functional currency. Revenues and expenses of such subsidiaries have been translated into U.S. Dollars at average exchange rates prevailing during the period. Assets and liabilities have been translated at the rates of exchange on the balance sheet date. The resulting translation gain and loss adjustments are recorded directly as a separate component of shareholders’ equity, unless there is a sale or complete liquidation of the underlying

 

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foreign investments. Foreign currency translation adjustments resulted in a loss of $4.0 million in fiscal 2009 and a gain of $8.6 million and $1.1 million in fiscal 2008 and 2007, respectively.

Transaction gains and losses that arise from exchange rate fluctuations on transactions denominated in a currency other than the functional currency are included in the results of operations as incurred. Net foreign currency transaction losses included in operations were $1.9 million in fiscal 2009. Net foreign currency transaction gains included in operations were $0.1 million in fiscal 2008 and $0.4 million in fiscal 2007. These gains and losses are included in ‘other non-operating income (expense)’ in the consolidated statements of income.

Revenue Recognition—In accordance with the Staff Accounting Bulletin No. 104, Revenue Recognition, guidance, the Company recognizes revenue when the following four basic criteria have been met: (1) persuasive evidence of an arrangement exists; (2) delivery has occurred or services have been rendered; (3) the fee is fixed and determinable; and (4) collectibility is reasonably assured.

 

   

Reagent sales

Revenue from the sale of the Company’s reagents to end users is primarily recognized upon shipment when both title and risk of loss transfer to the customer, unless there are specific contractual terms to the contrary. Revenue from the sale of the Company’s reagents to distributors is recognized FOB customs clearance when both title and risk of loss transfer to the customer.

 

   

Medical instrument sales

Revenue from the sale of the Company’s medical instruments without multiple deliverables is generally recognized upon shipment and completion of contractual obligations. Revenue from rentals of the Company’s medical instruments is recognized over the term of the rental agreement. Instrument service contract revenue is recognized over the term of the service contract.

In cases of sales or rental of instruments with multiple deliverables, the Company recognizes revenue on the sale of medical instruments in accordance with Emerging Issues Task Force (“EITF”) Issue No. 00-21, Accounting for Revenue Arrangements with Multiple Deliverables. The Company’s instrument contracts with multiple deliverables include the sale or rental of an instrument (including delivery, installation and training), the servicing of the instrument during the first year, and, in many cases, price guarantees for reagents and consumables purchased during the contract period. The Company has determined the fair value of certain of these elements, such as training and first year service. If the agreement does not include any price guarantees, the sales price in excess of the fair values of training and service is allocated to the instrument itself and recognized upon shipment and completion of contractual obligations relating to training and/or installation. The fair value of a training session is recognized as revenue when services are provided. The fair value of first year service is recognized over the first year of the contract. The Company believes it is not possible to determine the fair value of price guarantees. If the agreement contains price guarantees, the entire arrangement consideration is deferred and recognized over the related guarantee period. The allocation of the total consideration, which is based on the estimated fair value of the units of accounting, requires judgment by management.

In limited situations involving third-party lease arrangements, the Company has entered into repurchase agreements whereby if the consignee customer terminates the lease, the Company has agreed to repurchase the instrument for a purchase price equal to the remaining unpaid lease payments. The Company recognizes the revenue over the lease term if persuasive evidence exists that the consignee customer has not terminated the lease. The Company recognizes the instrument costs in these deferral situations when the instrument is installed and accepted by the customer.

 

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Sales subject to a plan of factoring

Sales subject to a plan of factoring are recorded at net realizable value (defined as gross sales less the annual estimated cost of factoring the sale). Should the factored sale remain uncollected by the factor at the end of one year, an estimate of the additional factoring discount is made and recorded monthly.

Shipping and Handling Charges and Sales Tax—The amounts billed to customers for shipping and handling of orders are classified as revenue and reported in the statements of income as net sales. The cost of handling customer orders and the cost of shipments are reported in the operating expense section of the statements of income as distribution expense. The cost of handling customer orders and the cost of shipments were approximately $13.7 million, $11.4 million and $9.6 million for the years ended May 31, 2009, 2008 and 2007, respectively. Sales taxes invoiced to customers and payable to government agencies are recorded on a net basis with the sales tax portion of a sales invoice directly credited to a liability account and the balance of the invoice credited to a revenue account.

Trade Accounts Receivable and Allowance for Doubtful Accounts—Trade receivables at May 31, 2009, totaling $57.0 million, and at May 31, 2008, totaling $52.7 million, are net of allowances for doubtful accounts of $2.2 million and $2.0 million, respectively. The allowance for doubtful accounts represents a reserve for estimated losses resulting from the inability of the Company’s customers to pay their debts. The collectibility of trade receivable balances is regularly evaluated based on a combination of factors such as customer credit-worthiness, past transaction history with the customer, current economic industry trends and changes in customer payment patterns. If it is determined that a customer will be unable to fully meet its financial obligation, such as in the case of a bankruptcy filing or other material events impacting its business, a specific allowance for doubtful accounts is recorded to reduce the related receivable to the amount expected to be recovered.

Advertising Costs—Advertising costs are expensed as incurred and are classified as selling and marketing operating expenses in the consolidated income statement. Advertising expenses were $0.7 million for the year ended May 31, 2009 and $0.4 million for each of the years ended May 31, 2008 and 2007.

Research and Development costs—Research and development costs are expensed as incurred and are disclosed as a separate line item in the consolidated income statement.

Loss contingencies—Certain conditions may exist as of the date the financial statements are issued which may result in a loss to the Company but which will only be determined and resolved when one or more future events occur or fail to occur. The Company’s management and its legal counsel assess such contingent liabilities, and such assessment inherently involves an exercise of judgment. In assessing loss contingencies related to legal proceedings that are pending against the Company or unasserted claims that may result in such proceedings, the Company’s legal counsel evaluates the perceived merits of any legal proceedings or unasserted claims as well as the perceived merits of the amount of relief sought or expected to be sought therein.

If the assessment of a contingency indicates that it is probable that a material loss is likely to occur and the amount of the liability can be estimated, then the estimated liability is accrued in the Company’s financial statements. If the assessment indicates that a potentially material loss contingency is not probable, but is reasonably possible, or is probable but cannot be estimated, then the nature of the contingent liability, together with an estimate of the range of possible loss if determinable and material, would be disclosed.

Loss contingencies considered remote are generally not accrued or disclosed unless they involve guarantees, in which case the nature of the guarantee would be disclosed. Legal costs relating to loss contingencies are expensed as incurred.

 

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Income Taxes—The Company’s income tax policy is to record the estimated future tax effects of temporary differences between the tax bases of assets and liabilities and amounts reported in the accompanying consolidated balance sheets, as well as operating loss and tax credit carry-forwards. The value of the Company’s deferred tax assets assumes that the Company will be able to generate sufficient future taxable income in applicable tax jurisdictions, based on estimates and assumptions. If these estimates and related assumptions change in the future, the Company may be required to record additional valuation allowances against its deferred tax assets resulting in additional income tax expense in the Company’s consolidated statements of income. In assessing the realizability of deferred tax assets, management considers whether it is more likely than not that some portion or all of the deferred tax assets will not be realized, and the Company considers the scheduled reversal of deferred tax liabilities, projected future taxable income, carry-back opportunities, and tax-planning strategies in making this assessment. Management assesses the need for additional valuation allowances quarterly.

In July 2006, the Financial Accounting Standard Board (“FASB”) issued Interpretation No. 48 (“FIN 48”), “Accounting for Uncertainty in Income Taxes—an interpretation of FASB Statement No. 109.” FIN 48 clarifies the accounting for uncertainty in income taxes recognized in an entity’s financial statements in accordance with SFAS No. 109, “Accounting for Income Taxes” and prescribes a recognition threshold and measurement attributes for financial statement disclosure of tax positions taken or expected to be taken on a tax return. Under FIN 48, the impact of an uncertain income tax position on an income tax return must be recognized at the largest amount that is more-likely-than-not to be sustained upon audit by the relevant taxing authority. An uncertain income tax position will not be recognized if it has less than a 50% likelihood of being sustained. The Company implemented FIN 48 effective June 1, 2007. See Note 14 to the consolidated financial statements.

Warranty—Each instrument sale includes a standard one-year service warranty. An extended warranty is sold separately. Approximately 95% of customers choose to purchase an extended warranty through the Company. The start of the one-year standard service period generally coincides with when the instrument revenue itself is recognized (upon customer acceptance/training, etc.). Standard warranty revenues are thus deferred until the instrument revenues are recognized and are then amortized over a 12-month period. If the instrument revenue is deferred due to a price protection clause, the revenue from warranty is also deferred and recognized over the same period as the revenue from the instrument sale. The price charged for the extended warranty is considered to be the fair market value of a first year warranty built into the consideration arrangement and is in accordance with the guidance provided in EITF 00-21.

Impact of Recently Issued Accounting Standards—

Adopted by the Company in fiscal 2009

In September 2006, the Financial Accounting Standards Board (“FASB”) issued SFAS No. 157, “Fair Value Measurements” (“SFAS No. 157”). SFAS No. 157 provides guidance for using fair value to measure assets and liabilities. This standard also responds to investors’ requests for expanded information about the extent to which companies measure assets and liabilities at fair value, the information used to measure fair value and the effect of fair value measurements on earnings. SFAS No. 157 applies whenever other standards require (or permit) assets or liabilities to be measured at fair value. The standard does not expand the use of fair value in any new circumstances. For financial assets and liabilities, SFAS No. 157 is effective for fiscal years beginning after November 15, 2007. The Company adopted the provisions for the financial assets and liabilities in fiscal 2009 and adoption did not have a material impact on the Company’s results of operations or financial position. For nonfinancial assets and liabilities, SFAS No. 157 is effective for fiscal years beginning after November 15, 2008, which will require the Company to adopt these provisions in fiscal 2010. The Company does not believe SFAS No. 157’s provisions for nonfinancial assets and liabilities will have a material impact on its results of operations or financial position.

 

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In February 2008, the FASB issued FASB Staff Position FAS 157-1, “Application of FASB Statement No. 157 to FASB Statement No. 13 and Other Accounting Pronouncements that Address Fair Value Measurements for Purposes of Lease Classification or Measurement under Statement 13,” (“FSP FAS 157-1”) This FSP excludes certain leasing transactions accounted for under FASB Statement No. 13, “Accounting for Leases,” from the scope of SFAS No. 157. The exclusion does not apply to fair value measurements of assets and liabilities recorded as a result of a lease transaction but measured pursuant to other pronouncements within the scope of Statement 157. FSP FAS 157-1 is effective upon the initial adoption of Statement 157. The adoption of FSP FAS 157-1 did not have a material impact on its results of operation or financial position of the Company.

In October 2008, the FASB issued FASB Staff Position No. FAS 157-3, Determining the Fair Value of a Financial Asset when the Market for That Asset Is Not Active (“FSP FAS 157-3”). FSP FAS 157-3 provides guidance on calculating fair value in an inactive market. This FSP is effective upon issuance, including prior periods for which financial statements have not been issued. The adoption of this FSP did not have an impact on our consolidated financial statements.

In February 2007, the FASB issued SFAS No. 159, “The Fair Value Option for Financial Assets and Financial Liabilities,” (“SFAS No. 159”) which gives entities the option to measure eligible financial assets, financial liabilities and firm commitments at fair value (i.e., the fair value option), on an instrument-by-instrument basis, that are otherwise not permitted to be accounted for at fair value under other accounting standards. The election to use the fair value option is available when an entity first recognizes a financial asset or financial liability or upon entering into a firm commitment. Subsequent changes in fair value must be recorded in earnings. SFAS No. 159 was adopted by the Company in its fiscal year beginning June 1, 2008. The adoption of SFAS No. 159 did not have a material impact on the Company’s results of operations or financial position as the Company did not elect to record any applicable amounts at fair value.

In June 2007, the Emerging Issues Task Force (“EITF”) issued EITF 07-3, “Accounting for Nonrefundable Advance Payments for Goods or Services to Be Used in Future Research and Development Activities” (“EITF 07-3”). EITF 07-3 addresses the diversity that exists with respect to accounting for the non-refundable portion of a payment made by a research and development entity for future research and development activities. The EITF concluded that an entity must defer and capitalize non-refundable advance payments made for research and development activities until the related goods are delivered or the related services are performed. Entities should continue to evaluate whether they expect the goods to be delivered or services to be rendered. If an entity does not expect the goods to be delivered or services to be rendered, the capitalized advance payment should be charged to expense. EITF 07-3 was effective for the Company in its fiscal year beginning June 1, 2008. The adoption of EITF 07-3 did not have a material impact on the Company’s results of operations or financial position.

In December 2007, the SEC issued Staff Accounting Bulletin No. 110, “Use of a Simplified Method in Developing Expected Term of Share Options” (“SAB 110”). SAB 110 expresses the current view of the staff that it will accept a company’s election to use the simplified method discussed in SAB 107 for estimating the expected term of “plain vanilla” share options regardless of whether the company has sufficient information to make more refined estimates. As permitted by SAB 110, the Company continues to use the simplified method as the Company does not have sufficient historical data for options with six-year contractual terms to estimate the expected term of share based awards.

In May 2008, the FASB issued Statement No. 162, “Hierarchy of Generally Accepted Accounting Principles”, which simply moves the requirements related to which authoritative literature to look to first from the audit standards to GAAP. SFAS 162 was effective on November 15, 2008. The adoption of SFAS 162 did not have a material effect on its consolidated financial statements.

 

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Not yet adopted by the Company

In December 2007, the FASB issued SFAS No. 141(R), “Business Combinations” (“SFAS 141(R)”). SFAS 141(R) will significantly change the financial accounting and reporting of business combination transactions. SFAS 141(R) establishes principles for how an acquirer recognizes and measures the identifiable assets acquired, liabilities assumed, and any noncontrolling interest in the acquiree; recognizes and measures the goodwill acquired in the business combination or a gain from a bargain purchase; and determines what information to disclose to enable users of the financial statements to evaluate the nature and financial effects of the business combination. SFAS 141(R) is effective for acquisition dates on or after the beginning of an entity’s first year that begins after December 15, 2008. The Company will apply the provisions of SFAS No. 141(R) to any business combination occurring on or after June 1, 2009, as required. The Company does not expect the adoption of SFAS No. 141 (R) to have a material impact on its consolidated financial statements.

In December 2007, the FASB issued SFAS No. 160, “Non-controlling Interests in Consolidated Financial Statements, an Amendment of ARB No. 51” (“FASB No. 160”). This statement establishes accounting and reporting standards for the non-controlling interest in a subsidiary and for the deconsolidation of a subsidiary. This statement is effective for fiscal years beginning on or after December 15, 2008. The Company does not expect the adoption of SFAS 160 to have a material effect on its consolidated financial statements.

In April 2008, the FASB posted FASB Staff Position No. FAS 142-3, Determination of the Useful Life of Intangible Assets (“FSP FAS 142-3”), which applies to recognized intangible assets that are accounted for pursuant to SFAS No. 142, Goodwill and Other Intangible Assets. FSP FAS 142-3 amends the factors an entity must consider when developing renewal or extension assumptions used in determining the useful life of a recognized intangible asset. It also requires entities to provide certain disclosures about its assumptions. FSP FAS 142-3 is effective for financial statements issued for fiscal years beginning after December 15, 2008 and interim periods within those fiscal years. The Company is currently evaluating the impact of the adoption of these requirements on its financial statements.

In June 2008, the FASB issued FASB Staff Position EITF 03-6-1, Determining Whether Instruments Granted in Share-Based Payment Transactions Are Participating Securities (“FSP EITF 03-6-1”). Under the FSP, unvested share-based payment awards that contain rights to receive nonforfeitable dividends (whether paid or unpaid) are participating securities, and should be included in the two-class method of computing EPS. The FSP is effective for fiscal years beginning after December 15, 2008, and interim periods within those years. The Company does not expect the adoption of FSP EITF 03-6-1 to have a material effect on its consolidated financial statements.

In May 2009, the FASB issued SFAS No. 165, “Subsequent Events” (“SFAS 165”). SFAS 165 establishes general standards of accounting for and disclosure of events that occur after the balance sheet date but before financial statements are issued. The effective date of SFAS 165 is interim or annual financial periods ending after June 15, 2009. The Company does not expect that the adoption of SFAS 165 will have a material effect on its consolidated financial statements.

This statement does not apply to subsequent events or transactions that are within the scope of other applicable generally accepted accounting principles that provide different guidance on the accounting treatment for subsequent events or transactions. SFAS No. 165 would apply to both interim financial statements and annual financial statements and should not result in significant changes in the subsequent events that are reported. SFAS No. 165 introduces the concept of financial statements being available to be issued. It requires the disclosure of the date through which a Company has evaluated subsequent events and the basis for that date, whether that represents the date the financial statements were issued or were available to be issued. SFAS No. 165 should alert all users of financial statements that an entity has not evaluated subsequent events after that date in the set of financial statements being presented. This statement is effective for interim or annual reporting periods ending after June 15, 2009, which corresponds to the Company’s first quarter of fiscal year 2010.

 

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In June 2009, the FASB issued SFAS No. 166 “Accounting for Transfers of Financial Assets” (“SFAS 166”). SFAS 166 is a revision to FASB Statement No. 140, Accounting for Transfers and Servicing of Financial Assets and Extinguishments of Liabilities, and will require more information about transfers of financial assets, including securitization transactions, and where entities have continuing exposure to the risks related to transfered financial assets. It eliminates the concept of a “qualifying special-purpose entity,” changes the requirements for derecognizing financial assets, and requires additional disclosures. SFAS 166 enhances information reported to users of financial statements by providing greater transparency about transfers of financial assets and an entity’s continuing involvement in transferred financial assets. SFAS 166 will be effective at the start of a reporting entity’s first fiscal year beginning after November 15, 2009, which corresponds to the Company’s first quarter of fiscal 2011. Early application is not permitted. The Company is currently evaluating the impact of adoption of SFAS 166.

In June 2009, the FASB issued SFAS No. 167 “Amendments to FASB Interpretation No. 46(R)” (“SFAS 167”). SFAS167 is a revision to FASB Interpretation No. 46 (Revised December 2003), Consolidation of Variable Interest Entities, and changes how a reporting entity determines when an entity that is insufficiently capitalized or is not controlled through voting (or similar rights) should be consolidated. The determination of whether a reporting entity is required to consolidate another entity is based on, among other things, the other entity’s purpose and design and the reporting entity’s ability to direct the activities of the other entity that most significantly impact the other entity’s economic performance. SFAS 167 will require a reporting entity to provide additional disclosures about its involvement with variable interest entities and any significant changes in risk exposure due to that involvement. A reporting entity will be required to disclose how its involvement with a variable interest entity affects the reporting entity’s financial statements. SFAS 167 will be effective at the start of a reporting entity’s first fiscal year beginning after November 15, 2009. Early application is not permitted. The Company is currently evaluating the impact, if any, of adoption of SFAS 167 on its financial statements.

In June 2009, the FASB issued SFAS No. 168 “The FASB Accounting Standards Codification and the Hierarchy of Generally Accepted Accounting Principles—A Replacement of FASB Statement No. 162” (“SFAS 168”). SFAS 168 establishes the FASB Accounting Standards CodificationTM (Codification) as the single source of authoritative U.S. generally accepted accounting principles (U.S. GAAP) recognized by the FASB to be applied by nongovernmental entities. Rules and interpretive releases of the SEC under authority of federal securities laws are also sources of authoritative U.S. GAAP for SEC registrants. SFAS 168 and the Codification are effective for financial statements issued for interim and annual periods ending after September 15, 2009, which corresponds to the Company’s second quarter of fiscal 2010. When effective, the Codification will supersede all existing non-SEC accounting and reporting standards. All other nongrandfathered non-SEC accounting literature not included in the Codification will become nonauthoritative. Following SFAS 168, the FASB will not issue new standards in the form of Statements, FASB Staff Positions, or Emerging Issues Task Force Abstracts. Instead, the FASB will issue Accounting Standards Updates, which will serve only to: (a) update the Codification; (b) provide background information about the guidance; and (c) provide the bases for conclusions on the change(s) in the Codification. The adoption of SFAS 168 will not have an impact on the Company’s consolidated financial statements.

 

2. ACQUISITIONS

BioArray

On March 11, 2008, the Company signed an Agreement and Plan of Merger with BioArray Solutions Ltd. (“BioArray”), a privately-held company based in Warren, NJ. The Company completed the acquisition of BioArray on August 4, 2008. Pursuant to the agreement, the Company acquired 100% of the outstanding common stock of BioArray for an aggregate purchase price of $115.2 million, including approximately $2.4 million of acquisition-related transaction costs. The purchase consideration was paid in cash. The Company has included the financial results of BioArray in its consolidated financial statements beginning August 4, 2008.

 

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The transaction costs included a payment of $1.4 million to TM Capital Corp., an investment bank which has represented the Company in a number of financial transactions, including the acquisition of BioArray Solutions in August 2008. Michael S. Goldman, one the Company’s former directors, is a Managing Director and founding principal of TM Capital Corp. With the receipt of these fees, as of August 4, 2008, Mr. Goldman no longer qualified as an “independent” director of the Company under Nasdaq Stock Market listing standards. As a result, Mr. Goldman resigned his positions as a member of the Compensation Committee and Governance Committee of the Board of Directors as of August 4, 2008 and did not stand for re-election at the 2008 annual meeting of shareholders.

BioArray is a pioneer in the field of molecular immunohematology or the DNA analysis of blood for the purpose of transfusions. Through the development of technologies supported by approximately 100 issued or pending patents, BioArray developed a novel and flexible technology platform that allows for a variety of DNA-based testing. The platform combines semiconductor technology, microparticle chemistry and molecular biology to bring a high degree of flexibility and performance to quantitative DNA and protein analysis.

Using this technology platform, BioArray developed complete assay solutions called the BeadChipTM system. The BeadChip system includes BeadChips featuring proprietary array designs as well as an automated Array Imaging System with “snapshot” image acquisition and the ImageStudioTM suite of integrated image analysis programs. The resulting integrated assay delivery system enables users to simultaneously perform dozens of customized tests on each patient sample in a semi-automated fashion. The Company believes this versatility makes the BeadChip format ideally suited to a wide scope of applications.

As of the acquisition date, the BeadChip system was being sold to and used by a number of customers for research use only purposes, which does not require FDA approval. After the acquisition was finalized the Company began the process of developing an automated instrument for the further commercialization of the BioArray solution. Although not required for research use only, Immucor expects to seek FDA and CE Mark approval once the automated instrument is developed to facilitate the wider commercialization of the product.

Immucor believes that molecular immunohematology will revolutionize transfusion medicine. Immucor also believes that its acquisition of BioArray provides new, strategic growth markets for the Company in both its current market of transfusion, through an offering complementary to its current product offerings, as well as the potential new market of transplantation. The purchase price for BioArray, and the resulting goodwill, reflects the significant growth opportunities that both companies believe BioArray’s technology and the combination of the companies’ complementary strengths represents for future growth.

Immucor’s leadership in blood banking industry automation and BioArray’s leadership in molecular diagnostic systems for specialty transfusion applications should allow the combined company to develop and deliver more precise molecular immunohematology solutions to enhance patient outcomes. Immucor also believes its proven strength in developing automated instruments combined with its FDA licensing and CE Mark process experience, its established distribution network, its sales and marketing capabilities as well as its financial resources will generate enhanced long-term growth opportunities for the commercialization of BioArray’s BeadChip system.

The acquisition has been accounted for as a purchase business combination. Assets acquired and liabilities assumed were recorded at their fair values as of August 4, 2008. Acquisition-related transaction costs include investment banking, legal and accounting fees, and other external costs directly related to the acquisition.

In connection with the transaction, BioArray formed a new company intended to commercialize BioArray’s technology in fields outside of blood transfusion and transplantation. The former equity holders of BioArray received an 81% ownership interest in the new company, and Immucor, through BioArray and for no additional consideration, received a 19% ownership interest. In the allocation of the BioArray purchase price, no value was allocated to Immucor’s interest in the new company. In April 2009, Immucor bought back the rights to the

 

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BioArray technology from the new company for approximately $1.0 million. As part of the liquidation of the new company, Immucor received approximately $140,000 in cash from the net assets, proportional to Immucor’s ownership interest.

Purchase Price Allocation

Under purchase accounting, the total purchase price was allocated to BioArray’s net tangible and identifiable intangible assets based on their estimated fair values as of August 4, 2008. The excess of the purchase price over the net tangible and identifiable intangible assets was recorded as goodwill. The allocation of the purchase price was based upon a valuation.

The following table details the purchase price allocation as of May 31, 2009 (in thousands):

 

Current assets

   $ 8,097   

Plant and equipment

     1,534   

Goodwill

     58,783   

Developed product technology

     51,000   

Deferred tax asset

     21,580   

Trademarks

     1,600   

Non-compete agreements

     1,650   
        

Total assets acquired

     144,244   

Deferred tax liability

     (22,752

Liabilities assumed

     (6,328
        

Total purchase price

   $ 115,164   
        

As of August 4, 2008, the Company made a preliminary determination of the amount of BioArray’s operating loss carryforwards that will be available to reduce the Company’s future taxable income, based on the rules governing allowable carryforward of losses when changes in ownership occur under Internal Revenue Code Section 382. This amount, which approximates $21.6 million, is recorded as a deferred tax asset. The net operating losses will expire at various times between 2021 and 2028. The Company has acquired intangible assets, not including goodwill, totaling approximately $54.3 million in this transaction. The amortization of these intangibles is not deductible for tax purposes and hence the Company has recorded a deferred tax liability of approximately $22.8 million to offset the future book amortization related to these intangibles. None of the goodwill of approximately $58.8 million resulting from the acquisition of BioArray is deductible for tax purposes.

Identifiable Intangible Assets

In performing the purchase price allocation, the Company considered, among other factors, the intended future use of acquired assets, analyses of historical financial performance and estimates of future performance of BioArray’s products. The fair value of intangible assets was based, in part, on a valuation completed using an income approach. The rates used to discount net cash flows to their present values were based on the Company’s weighted average cost of capital and ranged from 13.5% to 15%. These discount rates were determined after consideration of the Company’s rate of return on equity and the weighted average return on invested capital. The following table sets forth the components of intangible assets associated with the acquisition at May 31, 2009 (in thousands, except years):

 

Intangible Asset

   Fair Value    Accumulated
Amortization
   Net Book
Value
   Useful Life

Developed product technology

   $ 51,000    $ 2,500    $ 48,500    17 yrs.

Trademarks

     1,600      78      1,522    17 yrs.

Non-compete agreements

     1,650      275      1,375    5 yrs.
                       
   $ 54,250    $ 2,853    $ 51,397   
                       

 

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Developed product technology represents the value assigned to BioArray’s technology platform, the BeadChip system. The BeadChip system is sold as a product platform that has a number of applications. It was not possible to identify income streams associated with the various technologies within the portfolio. As such, the asset was valued as a single portfolio of technologies. The valuation was developed based upon the projected future cash flows and other valuation factors attributable to anticipated future sales of the BeadChip system. Immucor is in the process of developing an automated instrument to further commercialize the BeadChip system. This project was started post-acquisition. While there is some risk that the FDA licensing or CE Mark process for the future automated instrument would not be successful, Immucor did not consider this regulatory risk to be significant enough to classify the technology portfolio that comprises the BeadChip system as in-process research and development.

Trademarks represent the estimated fair value of the BioArray trademark. Non-compete agreements represent the estimated fair value of agreements with BioArray’s former management team members. Useful lives of the developed product technology and trademarks were based on estimated economic useful lives and the non-compete agreements useful lives were based on the terms in the agreements. Intangible assets are being amortized using the straight-line method.

Pro Forma Financial Information

The financial information in the table below summarizes the combined results of operations of Immucor and BioArray, on a pro forma basis, as though the companies had been combined as of the beginning of the periods presented. The pro forma financial information is presented for informational purposes only and is not indicative of the results of operations that would have been achieved if the acquisition had taken place at the beginning of the periods presented. Such pro forma financial information is based on the historical financial statements of Immucor and BioArray. This pro forma financial information is based on estimates and assumptions, which have been made solely for purposes of developing such pro forma information, including, without limitation, purchase accounting adjustments. The pro forma financial information presented below also includes depreciation and amortization based on the valuation of BioArray’s tangible assets and identifiable intangible assets resulting from the acquisition. The pro forma financial information presented below (in thousands, except per share data) does not reflect any synergies or operating cost reductions that may be achieved from the combined operations.

 

     Year Ended May 31,
     2009    2008

Revenue

   $ 300,863    $ 262,930

Net Income

   $ 73,633    $ 59,640

Earnings per common share—basic

   $ 1.05    $ 0.85
             

Earnings per common share—diluted

   $ 1.03    $ 0.84
             

IBG Immucor Limited

In June 2008, with the intent to sell our products directly in the United Kingdom, the Company acquired all of the outstanding shares of IBG Immucor Limited, a private company registered in, and the Company’s distributor for the United Kingdom, for an aggregate cash purchase price of $4.4 million.

 

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3. INVENTORY

Inventories are stated at the lower of cost (first-in, first-out basis) or market (net realizable value):

 

     May 31,
     2009    2008
     (in thousands)

Raw materials and supplies

   $ 8,506    $ 7,406

Work in process

     3,486      3,852

Finished goods

     26,264      20,970
             
   $ 38,256    $ 32,228
             

 

4. PROPERTY AND EQUIPMENT

 

     May 31,  
     2009     2008  
     (in thousands)  

Assets owned:

    

Land

   $ 59      $ 65   

Buildings and improvements

     1,732        1,888   

Leasehold improvements

     12,905        12,089   

Capital work-in-progress

     5,085        3,977   

Furniture and fixtures

     2,916        2,770   

Machinery and equipment

     61,945        51,736   
                
     84,642        72,525   

Less accumulated depreciation

     (41,181     (36,099
                

Property, plant and equipment—net

   $ 43,461      $ 36,426   
                

Depreciation expense was $9.6 million in fiscal year 2009, $8.0 million in fiscal year 2008, and $6.5 million in fiscal year 2007.

 

5. GOODWILL

Changes in the carrying amount of goodwill for the year ended May 31, 2009 and 2008 were as follows:

 

     May 31,
     2009     2008
     (in thousands)

Balance at beginning of year

   $ 36,758      $ 34,763

Additions:

    

Acquisition of IBG

     2,791        —  

Acquisition of BioArray

     58,783        —  

Foreign currency translation adjustment

     (1,077     1,995
              

Balance at end of year

   $ 97,255      $ 36,758
              

Goodwill is tested for impairment as at the end of the third quarter of each fiscal year or earlier if a triggering event occurs. Testing for impairment of goodwill confirmed that the carrying value of goodwill was not impaired, and consequently no impairment charges were recorded in the years ended May 31, 2009, 2008 and 2007.

 

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6. OTHER INTANGIBLE ASSETS

 

    Weighted
Average
Life
  May 31, 2009   May 31, 2008
      Cost   Accumulated
Amortization
    Net   Cost   Accumulated
Amortization
    Net
        (in thousands)   (in thousands)

Intangible assets subject to amortization:

             

Deferred licensing costs

  5 yrs   $ 581   $ (482   $ 99   $ 581   $ (472   $ 109

Distribution rights

  10 yrs     4,492     (2,358     2,134     3,416     (1,921     1,495

Customer lists

  16 yrs     4,911     (1,372     3,539     3,122     (1,022     2,100

Non-compete agreements

  5 yrs     1,650     (275     1,375     —       —          —  

Developed product technology

  17 yrs     51,095     (2,595     48,500     —       —          —  

Trademarks / tradenames

  17 yrs     1,615     (93     1,522     —       —          —  
                                         

Total amortizable assets

      64,344     (7,175     57,169     7,119     (3,415     3,704

Intangible assets not subject to amortization:

             

Deferred licensing costs

      4,186     —          4,186     3,793     —          3,793
                                         

Total non-amortizable assets

      4,186     —          4,186     3,793     —          3,793
                                         

Total other intangible assets

    $ 68,530   $ (7,175   $ 61,355   $ 10,912   $ (3,415   $ 7,497
                                         

Distribution rights include cost amounting to $1.4 million incurred in fiscal 2008 to reacquire distribution rights from the Company’s former French distributor to be amortized over the unexpired period of the cancelled distribution agreement, and $0.9 million, net, incurred in fiscal 2009 related to reacquiring the rights to BioArray’s technology from an organization that was formed during the time of the acquisition of BioArray, which was intended to commercialize BioArray’s technology in fields outside of blood transfusion and transplantation.

Amortization of intangible assets amounted to $3.7 million for the year ended May 31, 2009, $0.4 million for the year ended May 31, 2008 and $0.3 million for the year ended May 31, 2007. The following table presents our estimate of amortization expense for each of the five next succeeding fiscal years (in thousands):

 

Year Ending May 31:

  

2010

     4,185

2011

     4,185

2012

     4,185

2013

     3,815

2014

     3,483

Thereafter

     37,316
      
   $ 57,169
      

 

7. OTHER ASSETS

 

     May 31,
     2009    2008
     (in thousands)

Advance payment for IBG acquisition

   $ —      $ 4,432

Capitalized costs for BioArray acquisition

     —        722

Other non current assets

     781      544
             

Other assets

   $ 781    $ 5,698
             

 

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On June 2, 2008 the Company acquired all outstanding shares of IBG Immucor Limited, its distributor for the United Kingdom, for approximately $4.4 million. The Company remitted this amount on May 30, 2008 and it was reflected as ‘other assets’ in the accompanying consolidated balance sheets and under financing activities in the accompanying consolidated statements of cash flows for the fiscal year ending May 31, 2008. Appropriate purchase accounting entries, allocating the purchase consideration to the acquired assets and liabilities at respective fair values, were recorded in the first quarter of fiscal 2009 upon closing of the transaction.

 

8. ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES

 

     May 31,
     2009    2008
     (in thousands)

Sales and other taxes payable

   $ 4,236    $ 4,195

Salaries and wages

     10,763      7,438

Professional fees and dealer commission

     2,371      1,917

Royalties

     297      133

Accruals for pricing discounts to dealers

     219      243

Other accruals

     2,367      1,789
             

Accrued expenses and other current liabilities

   $ 20,253    $ 15,715
             

 

9. DEFERRED REVENUE

As described in Note 1, many of the Company’s medical instrument sales contracts involve multiple deliverables with price guarantees, and revenues from these contracts are deferred and recognized over the term of the agreements which are generally five years. The Company also defers revenue from service contracts over the term of the service agreements. The additions to and recognition of deferred revenue for the year ended May 31, 2009 and May 31, 2008 were as follows:

 

     May 31,  
     2009     2008  
     (in thousands)  

Balance at beginning of year

   $ 24,156      $ 19,682   

Additions to deferred revenue from acquisitions

     492        —     

Additions to deferred revenue from new contracts

     14,672        17,496   

Revenue recognized during the year

     (16,913     (13,271

Foreign currency translation adjustment

     (314     249   
                
     22,093        24,156   

Less: Deferred Revenue—current portion

     (11,222     (11,146
                

Balance at end of year

   $ 10,871      $ 13,010   
                

 

10. OTHER LONG TERM LIABILITIES

 

     May 31,  
     2009     2008  
     (in thousands)  

Severance indemnity for employees

   $ 968      $ 965   

Employment agreement at acquisition

     280        —     

Deferred leasehold improvement incentive

     1,961        1,791   
                
     3,209        2,756   

Less current portion

     (878     (562
                

Other long term liabilities

   $ 2,331      $ 2,194   
                

 

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The Company credits leasehold improvement incentives received from landlords to rent expense over the remaining term of the lease agreement.

 

11. COMMON STOCK

Reserved shares

At May 31, 2009, 2,697,286 shares of common stock were reserved for future issuance for the outstanding awards issued under the Immucor, Inc. 2005 Long-Term Incentive Plan and previous plans.

Stock repurchased

During fiscal 2009 and 2008, the Company either withheld from certain option exercises or reacquired from certain restricted shareholders an aggregate of 35,088 and 207,176 shares valued at $1.0 million and $5.5 million in compliance with the statutory tax withholding requirements. The Company retired these shares and disclosed their value as ‘Stock repurchases and retirements’ in the consolidated statement of shareholders’ equity and comprehensive income and as ‘Repurchase of common stock’ under financing activities in the consolidated statements of cash flows.

During fiscal 2009 and 2008, the Company also withheld 18,600 and 18,609 shares valued at $0.5 million and $0.5 million from an employee who exercised options and elected to pay the option exercise price by having shares withheld. These shares were also retired and their values were disclosed as ‘Stock repurchases and retirements’ in the consolidated statement of shareholders’ equity and comprehensive income and as ‘Non-cash investing and financing activities’ in the consolidated statements of cash flows.

The shares acquired were returned to the status of authorized, but unissued shares.

Stock repurchase program

The Company has a stock repurchase program and the Board of Directors had authorized the Company to repurchase up to 9,375,000 shares of the Company’s common stock.

During the year ended May 31, 2009, the Company spent $6.7 million to repurchase 295,409 shares of its common stock at an average per share price of $22.52. During the year ended May 31, 2008, the Company did not repurchase any shares of common stock under the repurchase program. During the year ended May 31, 2007, the Company spent $4.9 million to repurchase 281,969 shares at an average per share price of $17.23. Since 1998, the Company has repurchased 8,528,353 shares of its common stock having an aggregate value of approximately $57.6 million. An aggregate of 846,647 shares were available for repurchase under the program as of May 31, 2009.

 

12. SHARE–BASED COMPENSATION

All references to historical awards, outstanding awards and availability of shares for future grants under Immucor’s stock plans, as described below, and related prices per share have been retroactively adjusted, for comparability purposes, to reflect all applicable previous stock splits.

Impact of adoption of SFAS 123(R)

On adoption of SFAS 123(R) as of June 1, 2006, the unrecognized compensation expense associated with the remaining portion of the unvested outstanding awards was $4.5 million ($2.9 million, net of taxes). This compensation expense is being recognized through May 2010 on a straight-line basis over the weighted-average vesting period of approximately 1.75 years.

 

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The following table shows total share-based compensation expense for the year ended May 31, 2009, 2008 and 2007, included in the consolidated statements of income:

 

     For the Year Ended May 31,
          2009              2008              2007     
     (in thousands)

Cost of sales

   $ 841    $ 522    $ 446

Research and development

     531      378      290

Selling and marketing

     1,398      817      709

Distribution

     203      123      114

General and administrative

     2,931      1,838      1,564
                    

Total stock-based compensation

   $ 5,904    $ 3,678    $ 3,123
                    

Valuation method used and assumptions

The Company estimates the fair value of stock options using a Black-Scholes valuation model, consistent with the provisions of SFAS 123(R), Securities and Exchange Commission Staff Accounting Bulletins (“SAB”) 107 and 110 and the Company’s prior pro forma disclosures of net earnings, including the fair value of share-based compensation.

Key input assumptions used to estimate the fair value of stock options include the expected term until the exercise of the option, the expected volatility of the Company’s stock, risk-free rates of return and dividend yields, if any. The fair value for these options was estimated at the date of grant with the following weighted average assumptions:

 

     2009     2008     2007  

Risk-free interest rate (1)

   3.13   4.82   4.87

Expected volatility (2)

   42.41   40.37   47.10

Expected life (years) (3)

   4.25      4.25      4.25   

Expected dividend yield (4)

   —        —        —     

 

1. Based on the U.S. Treasury yield curve in effect at the time of grant.
2. Expected stock price volatility is based on the average historical volatility of the Company’s shares during the period corresponding to the expected life of the options.
3. Represents the period of time options are expected to remain outstanding. As the Company has so far only awarded “plain vanilla options” as described by SAB 107, the Company used the “simplified method” for determining the expected life of the options granted. Originally, under SAB 107, this method was allowed until December 31, 2007. However, on December 21, 2007, the SEC issued SAB 110, which allows a Company to continue to use the “simplified method” under certain circumstances, which the Company continues to use as the Company does not have sufficient historical data for options with six-year contractual terms to estimate the expected term of share-based awards.
4. The Company has not paid dividends on its common stock and does not expect to pay dividends on its common stock in the near future.

Plan summary

At an annual meeting of the Company’s shareholders held on December 13, 2005, the shareholders approved establishment of the Immucor, Inc. 2005 Long-Term Incentive Plan (the “2005 Plan”). The 2005 Plan replaced the Company’s preexisting stock option plans which have been frozen and remain in effect only to the extent of awards outstanding under these plans. Under the 2005 Plan, the Company is able to award stock options, stock appreciation rights, restricted stock, deferred stock, and other performance-based awards as incentive and compensation to employees and directors. Awards for up to 3,600,000 shares of the Company’s

 

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common stock may be granted under the 2005 Plan. There is a restriction on the number of shares that may be used for awards other than stock options (1,800,000), and a separate restriction on the number of shares that may be used for grants of incentive stock options (also 1,800,000), but there is no restriction on the number of shares that may be used for grants of non-incentive stock options. Options are granted at the closing market price on the date of the grant. Option awards generally vest equally over a four-year period and have a 6-year contractual term. Restricted stock awards generally vest equally over a five-year period. The 2005 Plan provides for accelerated vesting of option and restricted stock awards if there is a change in control, as defined in the plan.

Stock option activity

Compensation costs for stock options with tiered vesting terms are recognized evenly over the vesting periods. Activity for the Company’s option plans was as follows for the years ended May 31, 2009, 2008 and 2007:

 

     Number of
Shares
    Weighted
Average
Exercise Price
   Weighted
Average
Remaining
Contractual
Life (years)
   Aggregate
Intrinsic Value (1)
                     (in thousands)

Outstanding at May 31, 2006

   4,892,957      $ 4.14      

Granted

   222,716      $ 20.66      

Exercised

   (1,432,500   $ 2.73      

Forfeited

   (23,074   $ 12.61      

Expired

   (89,185   $ 6.29      
              

Outstanding at May 31, 2007

   3,570,914      $ 5.63    4.9    $ 92,665

Granted

   482,935      $ 29.30      

Exercised

   (1,248,219   $ 2.55      

Forfeited

   (46,279   $ 25.61      

Expired

   (309,410   $ 1.36      
              

Outstanding at May 31, 2008

   2,449,941      $ 12.03    4.9    $ 37,551

Granted

   866,995      $ 27.08      

Exercised

   (639,274   $ 5.79      

Forfeited

   (78,566   $ 26.53      

Expired

   (43,000   $ 11.51      
              

Outstanding at May 31, 2009

   2,556,096      $ 18.26    4.4    $ 9,948
              

Exercisable at May 31, 2009

   1,443,647      $ 11.65    4.1    $ 9,935
              

Shares available for future grants at May 31, 2009

   285,036           
              

 

1) The aggregate intrinsic value in the above table represents the total pre-tax intrinsic value (the difference between the Company’s closing stock price on the last trading day of the respective fiscal year and the exercise price, multiplied by the number of options) of in-the-money options.
2) The weighted-average grant-date fair value of share options granted during fiscal years 2009, 2008 and 2007 was $10.35, $11.53 and $8.99, respectively.
3) The total intrinsic value of share options exercised during fiscal years 2009, 2008 and 2007 was $14.7 million, $33.3 million and $34.9 million, respectively.

At May 31, 2009, 2008, and 2007, options for 1,443,647, 1,793,555 and 2,925,692 shares of common stock, respectively, were exercisable, at weighted average exercise prices of $11.65, $6.77 and $3.91, respectively. In fiscal 2009, 2008 and 2007, all options were granted with an exercise price that agreed to the fair value of the shares at the date of grant.

 

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The following table as of May 31, 2009 sets forth by group of exercise price ranges, the number of options outstanding, weighted average exercise prices and weighted average remaining contractual lives of options outstanding, and the number and weighted average exercise prices of options currently exercisable.

 

     Options Outstanding    Options Exercisable

Range of

Exercise Prices

   Number of
Shares
   Weighted Average
Exercise Price
   Weighted Average
Contractual Life
   Number of
Shares
   Weighted Average
Exercise Price

$0.01 –   $5.00

   466,794    $ 1.34    2.7    466,794    $ 1.34

  5.01 –   10.00

   394,007      6.13    4.7    394,007      6.13

10.01 –   20.00

   256,967      17.38    4.7    138,930      17.72

20.01 –   25.00

   220,660      20.56    5.9    185,650      20.10

25.01 –   30.00

   1,016,151      27.80    4.6    240,654      29.16

30.01 –   35.00

   201,517      31.65    5.0    17,612      32.30
                  
   2,556,096    $ 18.26    4.4    1,443,647    $ 11.65
                  

Restricted stock activity

The Company granted restricted stock awards to its employees for the first time in fiscal 2007. The following is a summary of the changes in unvested restricted stock for the fiscal years ended May 31, 2009, 2008 and 2007:

 

     Number of Shares     Weighted-Average
Grant-Date Fair
Value

Nonvested stock outstanding at May 31, 2007

   112,590      $ 17.51

Granted

   48,055        29.23

Vested

   (27,038     18.32

Forfeited

   (9,316     20.40
        

Nonvested stock outstanding at May 31, 2008

   124,291      $ 21.65

Granted

   57,055        26.90

Vested

   (30,120     20.93

Forfeited

   (10,036     24.55
        

Nonvested stock outstanding at May 31, 2009

   141,190      $ 23.72
        

Shares available for future grants at May 31, 2009

   1,591,737     
        

On April 21, 2009, the Compensation Committee approved the acceleration of the vesting of the stock options issued on June 8, 2007 to all employees other than officers of the Company. This action added approximately $0.9 million to the total compensation expense for fiscal 2009.

As of May 31, 2009, there was $10.8 million of total unrecognized compensation cost related to nonvested share-based compensation arrangements. This compensation cost is expected to be recognized through June 2014 based on existing vesting terms with the weighted average remaining expense recognition period being approximately 2.9 years.

 

13. RESTRUCTURING EXPENSES

On October 31, 2005, the Board of Directors of the Company approved a plan to close the Company’s Houston, Texas manufacturing facility. The decision to close the facility was driven by a number of factors including, in particular, the expense of operating two separate FDA licensed manufacturing facilities. As planned, the Houston facility was closed in December 2007.

 

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The Company did not incur any restructuring expenses during fiscal 2009 related to the closing of this facility. During fiscal years 2008 and 2007, the Company recorded charges of approximately $0.6 million and $1.1 million, respectively, in connection with this closure. The expense for fiscal 2008 consisted primarily of product consolidation expenses and relocation expenses, offset by a gain of $1.7 million on the sale of the Houston property. The expense for fiscal 2007 consisted primarily of product consolidation expenses, retention bonuses and relocation expenses.

 

14. INCOME TAXES

Sources of income before income taxes are summarized below (in thousands):

 

     Year Ended May 31,
     2009    2008    2007

Domestic Operations

   $ 107,843    $ 102,481    $ 83,729

Foreign Operations

     9,138      9,187      10,425
                    

Income before income taxes

   $ 116,981    $ 111,668    $ 94,154
                    

The provision for income taxes is summarized as follows (in thousands):

 

     Year Ended May 31,  
     2009     2008     2007  

Current:

      

Federal

   $ 33,347      $ 34,513      $ 31,701   

Foreign

     4,606        4,511        4,257   

State

     2,851        2,870        1,769   
                        
     40,804        41,894        37,727   
                        

Deferred:

      

Federal

     91        (1,231     (2,938

Foreign

     (626     (287     (494

State

     529        (162     (209
                        
     (6     (1,680     (3,641
                        

Provision for income taxes

   $ 40,798      $ 40,214      $ 34,086   
                        

Deferred income taxes reflect the net tax effects of: (a) temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and income tax purposes; and (b) operating loss and credit carry-forwards. Valuation allowances are established when necessary to reduce deferred tax assets to the amounts expected to be realized. Based on assessments of all available evidence including, but not limited to, the operating history and lack of profitability of certain subsidiaries, the Company is uncertain as to the ability to realize the subsidiaries’ net operating loss carry-forwards and tax benefits and, as a result, deferred tax valuation allowances have been recorded against these deferred tax assets as follows: Belgium, $1.1 million; Japan, $1.3 million, France, $1.1 million and BioArray, $2.6 million related to state net operating losses. Net operating loss carry-forwards for France and Belgium do not expire; operating loss carry-forwards for Japan expire beginning in 2012; federal operating loss carry-forwards for BioArray expire beginning in 2023; certain state operating loss carry-forwards for BioArray expire beginning in 2010 and are subject to a full valuation allowance; and credit carry-forwards for BioArray expire beginning in 2021.

 

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The tax effects of significant items comprising the Company’s net deferred tax assets at May 31, 2009 and 2008 are as follows (in thousands):

 

     Year Ended May 31,  
     2009     2008  

Deferred tax liabilities:

    

Intangibles

   $ (23,303   $ (1,513

Property, plant & equipment

     (2,539     (333

Prepaids and other

     (428     (1,676

Deferred tax assets:

    

Reserves not currently deductible

     4,913        4,524   

Deferred revenue

     4,690        4,176   

Compensation expense

     2,678        1,723   

Operating loss carry-forwards

Credit carry-forwards

    

 

21,672

2,253

  

  

    3,688   

Other

     6,008        3,191   

Uniform capitalization

     535        1,378   
                
     16,479        15,158   

Valuation allowance

     (6,134     (3,042
                

Net deferred tax assets

   $ 10,345      $ 12,116   
                

Deferred taxes are not provided for temporary differences of approximately $31.3 million, $23.6 million and $16.5 million as of May 31, 2009, 2008 and 2007, respectively, representing cumulative earnings of non-U.S. subsidiaries that are intended to be permanently reinvested. Computation of the potential deferred tax liability associated with these undistributed earnings is not practicable.

The Company’s effective tax rate differs from the federal statutory rate as follows:

 

     Year Ended May 31,  
     2009     2008     2007  

Federal statutory tax rate

   35   35   35

State income taxes, net of federal tax benefit

   3      3      3   

Extraterritorial income exclusion and PAD (1)

   (2   (1   (1

Tax exempt interest

   —        (1   (1

Change in deferred tax valuation allowance

   —        1      —     

Other

   (1   (1   —     
                  

Effective tax rate

   35   36   36
                  

 

(1) The extraterritorial income exclusion expired on December 31, 2006. The entire amount for fiscal years 2008 and 2009 relates to the Production Activity Deduction (PAD).

As a result of using compensation cost deductions arising from the exercise of nonqualified employee stock options for federal and state income tax purposes, the Company realized income tax benefits of $3.3 million in fiscal 2009, $7.5 million in fiscal 2008 and $12.3 million in fiscal 2007. These income tax benefits are recognized in the accompanying financial statements as additions to additional paid-in capital rather than as reductions of the respective income tax provisions because the related compensation deductions are not recognized as compensation expense for financial reporting purposes.

The Company adopted the provisions of Financial Interpretation No. 48, “Accounting for Uncertainty in Income Taxes—An Interpretation of FASB Statement No. 109 (“FIN 48”) on July 1, 2007. The total balance of

 

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unrecognized tax benefits that would affect the effective tax rate, if recognized, is $4.8 million. We do not currently anticipate that the total amount of unrecognized tax benefits will significantly increase or decrease during the twelve-month period ending May 31, 2010.

The Company recognizes interest and penalties accrued related to unrecognized tax benefits in income tax expense. The Company recognized $0.3 million in gross accrued interest expense during fiscal 2009 and in total, as of May 31, 2009, has recognized a liability for interest of $1.5 million. The Company has not recognized any accrued penalties since adoption of FIN 48.

The Company is subject to taxation in the U.S. and various states and foreign jurisdictions. The Company’s tax years for the fiscal years ended May 31, 2006 and May 31, 2008 remain subject to examination by U.S. tax authorities. The audit of the Company’s U.S. income tax return for the fiscal year ended May 31, 2007 was completed and the Company was assessed $0.4 million in additional tax and interest.

The following is a tabular reconciliation of the total amounts of unrecognized tax benefits, which is included in income taxes payable on the balance sheet, for the years ended May 31, 2009 and 2008 (in thousands):

 

Unrecognized tax benefit—June 1, 2007

   $ 5,130   

Gross increases in tax positions in the current period

     2,017   

Gross increases in tax positions in the prior period

     14   

Statute lapse

     (263
        

Unrecognized tax benefit—May 31, 2008

   $ 6,898   

Gross increases in tax positions in the current period

     4,370   

Settlements

     (492
        

Unrecognized tax benefit—May 31, 2009

   $ 10,776   
        

 

15. EARNINGS PER SHARE

The following table sets forth the computation of earnings per common share and common share—assuming dilution in accordance with SFAS No. 128, Earnings per Share:

 

     Year Ended May 31,
             2009                    2008                    2007        
     (Shares and $ in thousands, except per share data)

Numerator for basic and diluted earnings per share:

        

Net Income

   $ 76,183    $ 71,454    $ 60,068
                    

Denominator:

        

For basic earnings per share—weighted average shares basis

     70,382      69,867      68,441

Effect of dilutive stock options

     786      1,242      2,228
                    

Denominator for diluted earnings per share—adjusted weighted average shares basis

     71,168      71,109      70,669
                    

Earnings per common share—basic

   $ 1.08    $ 1.02    $ 0.88
                    

Earnings per common share—diluted

   $ 1.07    $ 1.00    $ 0.85
                    

The effect of 1,135,711, 46,990 and 36,916 out-of-the-money options was excluded from the above calculation as inclusion of these securities would be anti-dilutive for the years ended May 31, 2009, 2008 and 2007, respectively.

 

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On June 4, 2009, the Company, under an annual group award, issued options to employees to purchase 228,339 shares of common stock at an exercise price of $16.25 per share, which was the closing price on the date of the grant. The Company also issued 241,512 shares of restricted stock. These options and restricted stock are excluded in calculating the above diluted earnings per share as they were issued subsequent to year end but may have a dilutive effect on future earnings per share calculations.

 

16. DOMESTIC AND FOREIGN OPERATIONS

The Company’s operations and segments are organized around geographic areas. Immucor’s “Europe” segment includes the operations of Belgium, France, Germany, Italy, Portugal, Spain and the United Kingdom. The foreign locations principally function as distributors of products developed and manufactured by the Company in the United States and Canada. Effective August 4, 2008, U.S. operations also includes the operations of BioArray Solutions Ltd., which was acquired during the first quarter of fiscal 2009. The accounting policies applied in the preparation of the Company’s consolidated financial statements are applied consistently across the segments. Intersegment sales are recorded at market price and are eliminated in consolidation.

The basis of segmentation has been refined since our last annual report. The information for European locations has been combined in this report. In previous reports, the information for certain European locations was reported separately. All prior year data has been reclassified to align with current reporting.

Segment information concerning the Company’s domestic and foreign operations for the years ended May 31, 2009, 2008 and 2007 is summarized below (in thousands):

 

     For the Year Ended May 31, 2009
     U.S.    Europe    Canada    Japan    Elims     Consolidated

Traditional reagent revenues:

                

Unaffiliated customers

   $ 155,610    $ 26,445    $ 8,826    $ 8,396    $ —        $ 199,277

Affiliates

     5,355      4,286      371      —        (10,012     —  
                                          

Total

     160,965      30,731      9,197      8,396      (10,012     199,277

Capture revenues:

                

Unaffiliated customers

     39,276      20,793      3,246      830      —          64,145

Affiliates

     6,786      2,837      —        —        (9,623     —  
                                          

Total

     46,062      23,630      3,246      830      (9,623     64,145

Net instrument revenues:

                

Unaffiliated customers

     22,887      9,414      1,736      635      —          34,672

Affiliates

     5,342      6,892      —        —        (12,234     —  
                                          

Total

     28,229      16,306      1,736      635      (12,234     34,672

Net molecular immunohematology revenues:

                

Unaffiliated customers

     2,303      150      —        —        —          2,453

Affiliates

     224      8      —        —        (232     —  
                                          

Total

     2,527      158      —        —        (232     2,453

Net Sales

     237,783      70,825      14,179      9,861      (32,101     300,547

Income (loss) from operations

     108,691      3,292      5,146      288      (459     116,958

Depreciation

     5,623      3,537      234      173      —          9,567

Amortization

     3,386      277      —        76      —          3,739

Income tax (benefit) expense

     36,818      2,130      1,997      —        (147     40,798

Interest income

     921      833      199      4      —          1,957

Capital expenditures

     3,253      4,701      599      49      —          8,602

Property & equipment, net

     30,625      10,855      1,699      282      —          43,461

Goodwill

     76,586      7,089      7,981      5,599      —          97,255

Total assets at period end

     524,397      70,979      24,706      17,901      (186,643     451,340

 

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     For the Year Ended May 31, 2008
     U.S.    Europe    Canada    Japan     Elims     Consolidated

Traditional reagent revenues:

               

Unaffiliated customers

   $ 137,389    $ 24,188    $ 9,726    $ 7,785      $ —        $ 179,088

Affiliates

     5,689      3,720      297      —          (9,706     —  
                                           

Total

     143,078      27,908      10,023      7,785        (9,706     179,088

Capture revenues:

               

Unaffiliated customers

     33,979      15,766      3,105      522        —          53,372

Affiliates

     6,763      2,371      —        —          (9,134     —  
                                           

Total

     40,742      18,137      3,105      522        (9,134     53,372

Net instrument revenues:

               

Unaffiliated customers

     16,452      8,519      1,583      488        —          27,042

Affiliates

     2,724      3,789      —        —          (6,513     —  
                                           

Total

     19,176      12,308      1,583      488        (6,513     27,042

Net collagen revenues:

               

Unaffiliated customers

     1,697      —        —        —          —          1,697

Affiliates

     —        —        —        —          —          —  
                                           

Total

     1,697      —        —        —          —          1,697

Net Sales

     204,693      58,353      14,711      8,795        (25,353     261,199

Income (loss) from operations

     99,708      2,332      5,848      (240     95        107,743

Depreciation

     4,235      3,513      211      61        —          8,020

Amortization

     289      —        —        67        —          356

Restructuring expenses

     646      —        —        —          —          646

Income tax expense

     35,990      2,098      2,091      —          35        40,214

Interest income

     3,182      851      227      3        —          4,263

Capital expenditures

     6,298      4,924      260      91        —          11,573

Property & equipment, net

     24,429      10,130      1,434      433        —          36,426

Goodwill

     17,803      5,077      8,804      5,074        —          36,758

Total assets at period end

     315,921      62,390      22,824      16,917        (53,102     364,950

 

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     For the Year Ended May 31, 2007
     U.S.    Europe    Canada    Japan     Elims     Consolidated

Traditional reagent revenues:

               

Unaffiliated customers

   $ 123,272    $ 20,610    $ 8,588    $ 7,471      $ —        $ 159,941

Affiliates

     5,906      2,664      276      —          (8,846     —  
                                           

Total

     129,178      23,274      8,864      7,471        (8,846     159,941

Capture revenues:

               

Unaffiliated customers

     26,006      14,384      1,757      573        —          42,720

Affiliates

     5,716      1,255      —        —          (6,971     —  
                                           

Total

     31,722      15,639      1,757      573        (6,971     42,720

Net instrument revenues:

               

Unaffiliated customers

     10,335      5,923      612      57        —          16,927

Affiliates

     2,827      5,015      —        —          (7,842     —  
                                           

Total

     13,162      10,938      612      57        (7,842     16,927

Net collagen revenues:

               

Unaffiliated customers

     4,090      —        —        —          —          4,090

Affiliates

     —        —        —        —          —          —  
                                           

Total

     4,090      —        —        —          —          4,090

Net Sales

     178,152      49,851      11,233      8,101        (23,659     223,678

Income (loss) from operations

     81,393      4,268      4,856      (117     1,212        91,612

Depreciation

     3,256      2,901      192      176        —          6,525

Amortization

     282      —        —        64        —          346

Restructuring expenses

     1,051      —        —        —          —          1,051

Income tax (benefit) expense

     30,323      1,909      1,972      —          (118     34,086

Interest income

     2,035      700      105      1        —          2,841

Capital expenditures

     8,119      2,497      103      174        —          10,893

Property & equipment, net

     20,875      7,506      1,287      577        —          30,245

Goodwill

     17,803      4,391      8,176      4,393        —          34,763

Total assets at period end

     240,468      50,470      18,528      13,157        (47,145     275,478

The Company had net export sales to unaffiliated customers (in thousands):

 

     For the Year Ended May 31,
     2009    2008    2007
     (In thousands)

United States

   $ 5,036    $ 6,254    $ 5,440

Germany

     5,657      6,734      4,717

Canada

     1,794      1,873      1,803
                    

Total net export sales

   $ 12,486    $ 14,861    $ 11,960
                    

 

17. RETIREMENT PLAN

The Company maintains a 401(k) retirement plan covering its U.S. employees who meet the plan requirements. The Company matches a portion of employee contributions, which vest immediately. During the years ended May 31, 2009, 2008 and 2007, the Company’s matching contributions to the plan were approximately $0.8 million, $0.7 million and $0.6 million, respectively.

The Company’s Canadian affiliate maintains a defined contribution pension plan covering all Canadian employees, except temporary employees. The Company matches a portion of employee contributions to the plan, and each employee vests in the Company’s matching contributions once they have been a participant

 

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continuously for two years. During the years ended May 31, 2009, 2008 and 2007, the Company’s matching contributions to the plan were approximately $107,000, $90,000 and $76,000, respectively.

 

18. COMMITMENTS AND CONTINGENCIES

Lease Commitments

In the United States, the Company leases office, warehousing and manufacturing facilities under several operating lease agreements expiring at various dates through fiscal 2017 with a right to renew for an additional term in the case of most of the leases. Outside the United States, the Company leases foreign office and warehouse facilities under operating lease agreements expiring at various dates through fiscal 2017. The total leasing expenses for the Company was $3.7 million in fiscal 2009, $3.2 million in fiscal 2008 and $2.6 million in fiscal 2007.

The following is a schedule of approximate future annual lease payments under all operating leases that have initial or remaining non-cancelable lease terms as of May 31, 2009 (in thousands):

 

Year Ending May 31:

  

2010

   $ 2,887

2011

   $ 2,728

2012

   $ 2,362

2013

   $ 2,127

2014

   $ 2,343

Thereafter

   $ 3,505
      
   $ 15,952
      

Contingencies

In October 2007, the Company reported that the Federal Trade Commission (“FTC”) was investigating whether Immucor violated federal antitrust laws or engaged in unfair methods of competition through three acquisitions made in the period from 1996 through 1999, and whether Immucor or others engaged in unfair methods of competition by restricting price competition. The FTC letter requested that the Company provide certain documents and information to the FTC concerning those acquisitions and concerning its product pricing activities since then. On July 11, 2008, the FTC formalized its document and information requests into a Civil Investigative Demand (“CID”) and also required the Company to provide certain additional information within the same general scope of its previous requests. The Company has been cooperating with the FTC and intends to continue cooperating, and the Company is assured that the issuance of a formal CID does not indicate any dissatisfaction with its cooperation. As was previously the case, at this time the Company cannot reasonably assess the timing or outcome of the investigation or its effect, if any, on its business.

In April 2009, Immucor, Inc. received a subpoena from the United States Department of Justice, Antitrust Division (“DOJ”), requiring it to produce documents for the period beginning September 1, 2000 through the present, pertaining to an investigation of possible violations of the federal criminal antitrust laws in the blood reagents industry. The Company has been cooperating with the DOJ and intends to continue cooperating. At this time the Company cannot reasonably assess the timing or outcome of the investigation or its effect, if any, on its business.

Since May 18, 2009, a series of 30 lawsuits have been filed in 10 different United States District Courts against the Company, Ortho-Clinical Diagnostics, Inc. and Johnson & Johnson Health Care Systems, Inc. alleging that the defendants conspired to fix prices at which blood reagents are sold, asserting claims under Section 1 of the Sherman Act, and seeking declaratory and injunctive relief, treble damages, costs, and attorneys’

 

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fees. All of these complaints make substantially the same allegations and seek to certify a class of persons and entities who purchased blood reagents from any of the defendants between January 1, 2000 and the present. Most of the complaints limit the proposed class to persons and entities in the United States, but some do not contain that limitation. Certain of the plaintiffs have filed motions with the Judicial Panel on Multidistrict Litigation asking that these cases be centralized in a single United States District Court; arguments on these motions are scheduled to be heard July 30, 2009. Discovery has not yet begun in any of these cases. None of the courts have made a determination whether any of the plaintiffs’ claims have merit or should be allowed to proceed as a class action. The Company intends to vigorously defend against these cases. At this time the Company cannot reasonably assess the timing or outcome of this litigation or its effect, if any, on its business.

Other than as set forth, the Company is not currently subject to any material legal proceedings, nor, to the Company’s knowledge, is any material legal proceeding threatened against the Company. However, from time to time, the Company may become a party to certain legal proceedings in the ordinary course of business.

 

19. RELATED PARTY TRANSACTIONS

Michael S. Goldman, one the Company’s former directors, is a Managing Director and founding principal of TM Capital Corp., a New York, Boston and Atlanta based investment bank that represented the Company in a number of transactions prior to Mr. Goldman becoming a director of the Company in 2006. TM Capital Corp. represented the Company in the acquisition of BioArray and the Company continued to retain TM Capital Corp. for an annual fee of $120,000 until the acquisition closed in August 2008. At that time the Company paid transaction costs of $1.4 million to TM Capital Corp. relating to the acquisition. With the receipt of these fees, as of August 4, 2008, Mr. Goldman no longer qualified as an “independent” director of the Company under Nasdaq Stock Market listing standards. As a result, Mr. Goldman resigned his positions as a member of the Compensation Committee and Governance Committee of the Board of Directors as of August 4, 2008 and did not stand for re-election at the 2008 annual meeting of shareholders.

In addition to the $1.4 million paid to TM Capital Corp. relating to the acquisition of BioArray, the Company also paid fees to TM Capital totaling $30,000 in fiscal 2009 and $120,000 for each of the fiscal years 2008 and 2007, respectively.

 

20. SELECTED QUARTERLY FINANCIAL DATA (UNAUDITED)

 

Fiscal Year Ended

   Net
Sales
   Gross
Profit
   Income
from
Operations
   Net
Income
   Earnings
Per Common
Share
   Earnings Per
Common Share-
Assuming
Dilution
     (In thousands, except per share amounts)

May 31, 2009

                 

First Quarter

   $ 73,176    $ 53,425    $ 30,625    $ 19,956    $ 0.28    $ 0.28

Second Quarter

     73,021      53,558      27,862      17,338    $ 0.25    $ 0.24

Third Quarter

     75,309      53,789      29,298      19,457    $ 0.28    $ 0.27

Fourth Quarter

     79,041      55,239      29,173      19,432    $ 0.28    $ 0.27
                                 
   $ 300,547    $ 216,011    $ 116,958    $ 76,183    $ 1.08    $ 1.07
                                 

May 31, 2008

                 

First Quarter

   $ 63,632    $ 45,881    $ 27,076    $ 17,750    $ 0.26    $ 0.25

Second Quarter

     61,924      41,874      23,393      16,164    $ 0.23    $ 0.23

Third Quarter

     67,029      48,341      29,094      19,266    $ 0.28    $ 0.27

Fourth Quarter

     68,614      49,393      28,180      18,274    $ 0.26    $ 0.26
                                 
   $ 261,199    $ 185,489    $ 107,743    $ 71,454    $ 1.02    $ 1.00
                                 

The sum of the quarterly amounts of earnings per common share and diluted earnings per common share for the fiscal years ended May 31, 2009 and 2008 are different than the total due to rounding.

 

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Item 8.—Financial Statements and Supplementary Data (Continued).

 

  B. Supplementary Financial Information

Consolidated Financial Statement Schedule

Schedule II—Valuation and Qualifying Accounts

Years ended May 31, 2009, 2008 and 2007

 

     Beginning
Balance
   Charged to
Costs and
Expense
   Deductions     Ending
Balance

2009

          

Allowance for doubtful accounts

   $ 2,024    $ 848    $ (693   $ 2,179

Deferred income tax valuation allowance

   $ 3,042    $ 3,092    $ —        $ 6,134

2008

          

Allowance for doubtful accounts

   $ 1,726    $ 423    $ (125   $ 2,024

Provision for restructuring expense

   $ 443       $ (443   $ —  

Deferred income tax valuation allowance

   $ 2,644    $ 398    $ —        $ 3,042

2007

          

Allowance for doubtful accounts

   $ 1,950    $ 364    $ (588   $ 1,726

Provision for restructuring expense

   $ 342    $ 358    $ (257   $ 443

Deferred income tax valuation allowance

   $ 3,029    $ —      $ (385   $ 2,644

 

Note 1: “Deductions” for the “Allowance for doubtful accounts” represent accounts written off during the period less recoveries of accounts previously written off and exchange differences generated.

Item 9.—Changes in and Disagreements with Accountants on Accounting and Financial Disclosure.

Not applicable.

Item 9A.—Controls and Procedures.

(a) Evaluation of Disclosure Controls and Procedures

The Company, under the supervision and with the participation of its management, including the Chief Executive Officer and the Chief Financial Officer, evaluated the effectiveness of the design and operation of the Company’s “disclosure controls and procedures” (as defined in Rule 13a-15(e) promulgated under the Securities Exchange Act of 1934, as amended (the “Exchange Act”).

Based on their evaluation as of May 31, 2009, the Chief Executive Officer and Chief Financial Officer have concluded that the Company’s disclosure controls and procedures are effective to ensure that the information required to be disclosed by the Company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in SEC rules and forms and that such information is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosures.

(b) Changes in Internal Controls

There were no changes in our internal control over financial reporting during the quarter ended May 31, 2009 that have materially affected, or are reasonably likely to materially affect our internal control over financial reporting.

 

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(c) Management’s Report on Internal Control over Financial Reporting

The management of Immucor is responsible for establishing and maintaining adequate internal control over financial reporting, as such is defined in Rules 13a-15(f) promulgated under the Securities Exchange Act of 1934, as amended, and for performing an assessment of the effectiveness of internal control over financial reporting as of May 31, 2009. The Company’s internal control over financial reporting is a process that is 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.

Internal control systems, no matter how well designed, have inherent limitations. Therefore, even those systems determined to be effective can provide only reasonable assurance with respect to financial statement preparation and presentation, and may not prevent or detect misstatements. In addition, projections of any evaluation of effectiveness to future periods are subject to risks that controls may become inadequate because of changes in conditions, or that the degree of compliance with policies or procedures may deteriorate.

Immucor’s management performed an assessment of the effectiveness of the Company’s internal control over financial reporting as of May 31, 2009, using the criteria described in “Internal Control—Integrated Framework” issued by the Committee of Sponsoring Organizations of the Treadway Commission (“COSO”). The objective of this assessment is to determine whether the Company’s internal control over financial reporting was effective as of May 31, 2009. Immucor’s management has concluded that, as of May 31, 2009, its internal control over financial reporting was effective to provide reasonable assurance regarding the reliability of its financial reporting and the preparation of its financial statements for external purposes in accordance with United States generally accepted accounting principles.

During the first quarter of fiscal year 2009, the Company acquired BioArray Solutions, Ltd. Refer to Note 2 of Notes to the Consolidated Financial Statements for additional information regarding this acquisition. However, due to a major systems implementation at BioArray commenced during the 2009 fiscal year and as permitted by related SEC Staff interpretive guidance for newly acquired businesses, the Company excluded BioArray from management’s annual assessment of the effectiveness of the Company’s internal control over financial reporting as of May 31, 2009. This acquisition constituted 26% of total assets as of May 31, 2009 and 1% of revenues for the year then ended. This subsidiary will be included in future evaluations of the effectiveness of the Company’s disclosure controls and procedures when these systems have been implemented.

Grant Thornton LLP, the Company’s Independent Registered Public Accounting Firm, has issued an attestation report on the effectiveness of the Company’s internal control over financial reporting. It appears in Item 8 immediately before the Consolidated Financial Statements.

 

/s/    DR. GIOACCHINO DECHIRICO             /s/    RICHARD A. FLYNT        
Dr. Gioacchino DeChirico     Richard A. Flynt
President and Chief Executive Officer     Vice President—Chief Financial Officer

Item 9B.—Other Information.

Not applicable.

 

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PART III

We will file a definitive Proxy Statement for our 2009 Annual Meeting of Shareholders with the SEC, pursuant to Regulation 14A, not later than 120 days after the end of our fiscal year. Accordingly, certain information required by Part III has been omitted under General Instruction G (3) to Form 10-K. Only those sections of our definitive Proxy Statement that specifically address the items set forth herein are incorporated by reference.

Item 10.—Directors, Executive Officers and Corporate Governance.

The information required by Item 10 is hereby incorporated by reference from the Company’s definitive Proxy Statement relating to the Company’s 2009 Annual Meeting of Shareholders, to be filed with the Securities and Exchange Commission within 120 days following the end of the Company’s fiscal year.

Item 11.—Executive Compensation.

The information required by Item 11 is hereby incorporated by reference from the Company’s definitive Proxy Statement relating to the Company’s 2009 Annual Meeting of Shareholders, to be filed with the Securities and Exchange Commission within 120 days following the end of the Company’s fiscal year.

Item 12.—Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.

The information required by Item 12 is hereby incorporated by reference from the Company’s definitive Proxy Statement relating to the Company’s 2009 Annual Meeting of Shareholders, to be filed with the Securities and Exchange Commission within 120 days following the end of the Company’s fiscal year.

Item 13.—Certain Relationships and Related Transactions, and Director Independence.

The information required by Item 13 is hereby incorporated by reference from the Company’s definitive Proxy Statement relating to the Company’s 2009 Annual Meeting of Shareholders, to be filed with the Securities and Exchange Commission within 120 days following the end of the Company’s fiscal year.

Item 14.—Principal Accountant Fees and Services.

The information required by Item 14 is hereby incorporated by reference from the Company’s definitive Proxy Statement relating to the Company’s 2009 Annual Meeting of Shareholders, to be filed with the Securities and Exchange Commission within 120 days following the end of the Company’s fiscal year.

 

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PART IV

Item 15.—Exhibits and Financial Statement Schedules.

 

(a) Documents filed as part of this report:

 

  1. Consolidated Financial Statements.

The Consolidated Financial Statements, Notes thereto, and Report of Independent Registered Public Accounting Firm thereon are included in Part II, Item 8 of this report.

 

  2. Consolidated Financial Statement Schedule included in Part II, Item 8 of this report.

Schedule II—Valuation and Qualifying Accounts.

Other financial statement schedules are omitted as they are not required or not applicable.

 

  3. Exhibits.

See Item 15(b) below.

 

(b) Exhibits

The following exhibits are filed as part of this report or hereby incorporated by reference to exhibits previously filed with the SEC:

 

  2.1    Agreement of Plan and Merger by and among the Company, Merger Sub and BioArray dated March 11, 2008 (incorporated by reference to Exhibit 2.1 to Immucor, Inc.’s Current Report on Form 8-K filed on March 17, 2008).
  3.1    Amended and Restated Articles of Incorporation dated September 7, 2006 (incorporated by reference to Exhibit 3.1 to Immucor, Inc.’s Quarterly Report on Form 10-Q filed on January 5, 2007).
  3.2    Amended and Restated Bylaws (incorporated by reference to Exhibit 3.1 to Immucor, Inc.’s Current Report on Form 8-K filed on September 13, 2006).
  4.1    Amended and Restated Shareholder Rights Agreement dated as of November 20, 2001 between Immucor, Inc. and EquiServe Trust Company, N.A. as Rights Agent (incorporated by reference to Exhibit 4.1 to Immucor, Inc.’s quarterly report on Form 10-Q filed on January 14, 2002).
10.1    Standard Industrial Lease, dated July 21, 1982, between the Company and Colony Center, Ltd. (incorporated by reference to Exhibit 10.2 to Immucor, Inc.’s Annual Report on Form 10-K for the fiscal year ended May 31, 1985).
10.1-1    Lease Amendment dated June 28, 1989, between the Company and Colony Center, Ltd. (incorporated by reference to Exhibit 10.1-1 to Immucor, Inc.’s Annual Report on Form 10-K for the fiscal year ended May 31, 1989).
10.1-2    Lease Amendment dated November 8, 1991, between the Company and Colony Center, Ltd. (incorporated by reference to Exhibit 10.1-1 to Immucor, Inc.’s Annual Report on Form 10-K for the fiscal year ended May 31, 1992).
10.1-3    Lease Agreement, dated February 2, 1996, between the Company and Connecticut General Life Insurance Company (incorporated by reference to Exhibit 10.1-3 to Immucor, Inc.’s Annual Report on Form 10-K for the fiscal year ended May 31, 1996).
10.1-4    Lease Amendment, dated March 8, 1998, between the Company and Connecticut General Life Insurance Company (incorporated by reference to Exhibit 10.1-4 to Immucor, Inc.’s Annual Report on Form 10-K for the fiscal year ended May 31, 1998).

 

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10.1-5    Lease Amendment, dated August 11, 1999, between the Company and Connecticut General Life Insurance Company (incorporated by reference to Exhibit 10.1-5 to Immucor, Inc.’s Annual Report on Form 10-K for the fiscal year ended May 31, 1999).
10.1-6    Lease Amendment, dated August 8, 2002, between the Company and Crocker Realty Trust, L.P., successor in interest to Connecticut General Life Insurance Company (incorporated by reference to Exhibit 10.1-6 to Immucor, Inc.’s Annual Report on Form 10-K for the fiscal year ended May 31, 2007).
10.1-7    Amended and Restated Lease Amendment, dated January 18, 2005, between the Company and AP-Southeast Realty LP, successor by name change to Crocker Realty Trust, L.P., successor in interest to Connecticut General Life Insurance Company (incorporated by reference to Exhibit 10.1-7 to Immucor, Inc.’s Annual Report on Form 10-K for the fiscal year ended May 31, 2007).
10.1-8    Lease Amendment, dated March 31, 2006, between the Company and AP-Southeast Realty LP, successor by name change to Crocker Realty Trust, L.P., successor in interest to Connecticut General Life Insurance Company (incorporated by reference to Exhibit 10.1-8 to Immucor, Inc.’s Annual Report on Form 10-K for the fiscal year ended May 31, 2007).
10.1-9    Amended and Restated Office Lease Agreement [2975 Building], dated January 26, 2007, between the Company and Business Park Investors Group, successor in interest to AP-Southeast Realty LP, successor by name change to Crocker Realty Trust, L.P., successor in interest to Connecticut General Life Insurance Company (incorporated by reference to Exhibit 10.1-9 to Immucor, Inc.’s Annual Report on Form 10-K for the fiscal year ended May 31, 2007).
10.1-10    Amended and Restated Office Lease Agreement [2985 Building], dated January 26, 2007, between the Company and Business Park Investors Group, successor in interest to AP-Southeast Realty LP, successor by name change to Crocker Realty Trust, L.P., successor in interest to Connecticut General Life Insurance Company (incorporated by reference to Exhibit 10.1-10 to Immucor, Inc.’s Annual Report on Form 10-K for the fiscal year ended May 31, 2007).
10.1-11    Amended and Restated Office Lease Agreement [2990 Building], dated January 26, 2007, between the Company and Business Park Investors Group, successor in interest to AP-Southeast Realty LP, successor by name change to Crocker Realty Trust, L.P., successor in interest to Connecticut General Life Insurance Company (incorporated by reference to Exhibit 10.1-11 to Immucor, Inc.’s Annual Report on Form 10-K for the fiscal year ended May 31, 2007).
10.1-12    Amended and Restated Office Lease Agreement [3130 Building], dated January 26, 2007, between the Company and Business Park Investors Group, successor in interest to AP-Southeast Realty LP, successor by name change to Crocker Realty Trust, L.P., successor in interest to Connecticut General Life Insurance Company (incorporated by reference to Exhibit 10.1-12 to Immucor, Inc.’s Annual Report on Form 10-K for the fiscal year ended May 31, 2007).
10.1-13    Amended and Restated Office Lease Agreement [3150 Building], dated January 26, 2007, between the Company and Business Park Investors Group, successor in interest to AP-Southeast Realty LP, successor by name change to Crocker Realty Trust, L.P., successor in interest to Connecticut General Life Insurance Company (incorporated by reference to Exhibit 10.1-13 to Immucor, Inc.’s Annual Report on Form 10-K for the fiscal year ended May 31, 2007).
10.1-14    Amended and Restated Office Lease Agreement [7000 Building], dated January 26, 2007, between the Company and Business Park Investors Group, successor in interest to AP-Southeast Realty LP, successor by name change to Crocker Realty Trust, L.P., successor in interest to Connecticut General Life Insurance Company (incorporated by reference to Exhibit 10.1-14 to Immucor, Inc.’s Annual Report on Form 10-K for the fiscal year ended May 31, 2007).

 

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10.2    Industrial Multi-Tenant Lease between the Company and AMB Property, L.P., dated December 29, 2005 (incorporated by reference to Exhibit 10.2 to Immucor, Inc.’s Annual Report on Form 10-K for the fiscal year ended May 31, 2007).
10.3    United States Department of Health and Human Services Establishment License dated December 28, 1982, for the manufacture of biological products (incorporated by reference to Exhibit 10.12 to Registration Statement No. 33-966 on Form S-1).
10.4    United States Department of Health and Human Services Product License dated December 28, 1982, for the manufacture and sale of reagent red blood cells (incorporated by reference to Exhibit 10.13 to Registration Statement No. 33-966 on Form S-1).
10.5    United States Department of Health and Human Services Product License dated May 20, 1983, for the manufacture and sale of blood grouping sera (incorporated by reference to Exhibit 10.14 to Registration Statement No. 33-966 on Form S-1).
10.6    United States Department of Health and Human Services Product License date November 18, 1983, for the manufacture and sale of anti-human serum (incorporated by reference to Exhibit 10.15 to Registration Statement No. 33-966 on Form S-1).
10.7*    Immucor, Inc. 2005 Long-Term Incentive Plan (incorporated by reference to Exhibit 4.2 to Immucor, Inc.’s Registration Statement No. 333-131902 filed on April 5, 2006).
10.8*    2003 Stock Option Plan (incorporated by reference to Exhibit 10.8 to Immucor, Inc.’s Annual Report on Form 10-K filed on August 16, 2004).
10.8-1*    Amended and Restated 2003 Stock Option Plan, amended and restated as of November 10, 2004 (incorporated by reference to Exhibit 10.8-1 to Immucor, Inc’s Annual Report on Form 10-K filed on October 19, 2005).
10.9*    Amended and Restated 1998 Stock Option Plan (incorporated by reference to Exhibit 10.9 to Immucor, Inc.’s Annual Report on Form 10-K filed on August 16, 2004).
10.10*    1990 Stock Option Plan, including form of Stock Option Agreement used thereunder (incorporated by reference to Exhibit 10.15 to Immucor, Inc.’s Annual Report on Form 10-K for the fiscal year ended May 31, 1995).
10.11*    Form of indemnification agreement between the Company and certain directors (incorporated by reference to Exhibit 10.22 to Immucor, Inc.’s quarterly report on Form 10-Q filed January 14, 2002).
10.12    Loan Agreement among Immucor, Inc., as borrower, and SunTrust Bank, as lender, dated as of December 18, 2003 (incorporated by reference to Exhibit 10.1 to Immucor, Inc.’s quarterly report on Form 10-Q filed on April 14, 2004).
10.13*    Employment Agreement dated May 1, 2004, between the Company and Ralph A. Eatz (incorporated by reference to Exhibit 10.20 to Immucor, Inc.’s Annual Report on Form 10-K filed on August 16, 2004).
10.14-1*    Amendment No. 1 to Employment Agreement, dated May 22, 2006, by and between the Company and Ralph A. Eatz (incorporated by reference to Exhibit 10.4 to Immucor, Inc.’s Current Report on Form 8-K filed on May 25, 2006).
10.14-2*    Amendment No. 2 to Employment Agreement, dated June 1, 2007, by and between the Company and Ralph A. Eatz (incorporated by reference to Exhibit 10.5 to Immucor, Inc.’s Current Report on Form 8-K filed on June 25, 2007).
10.15*    Employment Agreement, dated December 1, 2003, by and between the Company and Gioacchino De Chirico (incorporated by reference to Exhibit 10.21/A to Immucor, Inc.’s amended Annual Report on Form 10-K/A filed on December 6, 2006).

 

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10.15-1*   Amendment No. 1 to Employment Agreement, dated May 1, 2004, by and between the Company and Dr. Gioacchino De Chirico (incorporated by reference to Exhibit 10.22 to Immucor, Inc.’s Annual Report on Form 10-K filed on August 16, 2004).
10.15-2*   Amendment to Employment Agreement, dated June 1, 2007, by and between the Company and
Dr. Gioacchino De Chirico (incorporated by reference to Exhibit 10.2 to Immucor, Inc.’s Current Report on Form 8-K filed on June 25, 2007).
10.16*   Employment Agreement dated April 1, 2007, between the Company and Philip H. Moïse (incorporated by reference to Exhibit 10.1 to Immucor, Inc.’s Quarterly Report on Form 10-Q filed on April 5, 2007).
10.17*   Employment Agreement by and between the Company and Richard A. Flynt, effective December 10, 2007 (incorporated by reference to Exhibit 10.1 to Immucor, Inc.’s Current Report on Form 8-K filed on November 21, 2007).
10.18*   Fiscal Year 2009 Bonus Plan and Fiscal Year 2008 Long-Term Incentive Awards Plan (incorporated by reference to Immucor, Inc.’s Current Report on Form 8-K filed on May 28, 2008).
10.19*   Fiscal Year 2010 Bonus and Long-Term Incentive Plan (incorporated by reference to Immucor, Inc.’s Current Report on Form 8-K filed on June 10, 2009).
21**   Subsidiaries of the Registrant.
23.1**   Consent of Grant Thornton LLP, Independent Registered Public Accounting Firm.
31.1**   Certification of Principal Executive Officer Pursuant to Rule 13a-14(a).
31.2**   Certification of Principal Financial Officer Pursuant to Rule 13a-14(a).
32.1**   Certification of Chief Executive Officer Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
32.2**   Certification of Chief Financial Officer Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
99.1**   Summary of Lawsuits

 

* Denotes a management contract or compensatory plan or arrangement.
** Filed or furnished herewith

 

(c) Financial Statement Schedule

No financial statement schedules are filed herewith because (1) such schedules are not required or (2) the information has been presented in Item 8 of this annual report on Form 10-K.

 

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SIGNATURES

Pursuant to the requirements of Section 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.

 

IMMUCOR, INC.
By:   /s/    DR. GIOACCHINO DE CHIRICO        
 

Dr. Gioacchino De Chirico,

President and Chief Executive Officer

  (Principal Executive Officer)

July 24, 2009

Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant and in the capacities and on the dates indicated.

 

/s/    DR. GIOACCHINO DE CHIRICO        

Dr. Gioacchino De Chirico,

President and Chief Executive Officer

(Principal Executive Officer)

July 24, 2009

 

/s/    RICHARD A. FLYNT        

Richard A. Flynt,

Vice President—Chief Financial Officer

(Principal Financial and Accounting Officer)

July 24, 2009

 

/s/    JAMES CLOUSER        

James Clouser,

Director

July 24, 2009

 

/s/    RALPH A. EATZ        

Ralph A. Eatz,

Director

July 24, 2009

 

/s/    HIROSHI HOKETSU        

Hiroshi Hoketsu,

Director

July 24, 2009

 

/s/    RONNY LANCASTER        

Ronny Lancaster,

Director

July 24, 2009

 

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/s/    PAUL HOLLAND        

Paul Holland,

Director

July 24, 2009

 

/s/    CHRIS PERKINS        

Chris Perkins,

Director

July 24, 2009

 

/s/    JOSEPH E. ROSEN        

Joseph E. Rosen,

Director

July 24, 2009

 

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EXHIBIT INDEX

 

Number

  

Description

21    Subsidiaries of the Registrant.
23.1    Consent of Grant Thornton LLP, Independent Registered Public Accounting Firm.
31.1    Certification of Principal Executive Officer Pursuant to Rule 13a-14(a).
31.2    Certification of Principal Financial Officer Pursuant to Rule 13a-14(a).
32.1    Certification of Chief Executive Officer Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
32.2    Certification of Chief Financial Officer Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
99.1    Summary of Lawsuits

 

86

EX-21 2 dex21.htm SUBSIDIARIES OF THE REGISTRANT SUBSIDIARIES OF THE REGISTRANT

Exhibit 21

Subsidiaries of Registrant

 

Subsidiary

  

Jurisdiction of Organization

Immucor Medizinische Diagnostik GmbH

   Germany

Immucor Italia S.p.A.

   Italy

Immucor Diagnosticos Medicos Lda.

   Portugal

Dominion Biologicals Limited

   Canada

Immucor, S.L.

   Spain

Immucor Gamma Benelux SPRL.

   Belgium

Immucor K. K.

   Japan

Immucor France S.A.S.

   France

IBG Immucor Limited

   United Kingdom

BCA Acquisition Corporation

   United States (Georgia)

BioArray Solutions Limited

   United States (New Jersey)

The Company owns, directly or indirectly, 100% of each of the above entities.

EX-23.1 3 dex231.htm CONSENT OF GRANT THORNTON LLP, INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM CONSENT OF GRANT THORNTON LLP, INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

Exhibit 23.1

CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

We have issued our reports dated July 23, 2009, with respect to the consolidated financial statements and schedule and internal control over financial reporting included in the Annual Report of Immucor, Inc. (the “Company”) on Form 10-K for the year ended May 31, 2009. We hereby consent to the incorporation by reference of said reports in the Registration Statements of the Company on Forms S-8 (file numbers 333-131399, 33-41406, 33-49882, 033-62097, 333-90552, 333-109210, and 333-131902).

/s/ GRANT THORNTON LLP

Atlanta, Georgia

July 23, 2009

EX-31.1 4 dex311.htm SECTION 302 CEO CERTIFICATION SECTION 302 CEO CERTIFICATION

Exhibit 31.1

I, Gioacchino De Chirico, certify that:

 

1. I have reviewed this annual report on Form 10-K of Immucor, Inc.;

 

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

 

3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

 

4. The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f) for the registrant and have:

 

  a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

 

  b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, 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;

 

  c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

 

  d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

 

5. The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

 

  a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

 

  b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

Date: July 24, 2009

 

/s/ Gioacchino De Chirico

Gioacchino De Chirico,
Chief Executive Officer (Principal Executive Officer)
EX-31.2 5 dex312.htm SECTION 302 CFO CERTIFICATION SECTION 302 CFO CERTIFICATION

Exhibit 31.2

I, Richard A. Flynt, certify that:

 

1. I have reviewed this annual report on Form 10-K of Immucor, Inc.;

 

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

 

3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

 

4. The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-l5(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f) for the registrant and have:

 

  a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

 

  b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, 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;

 

  c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

 

  d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

 

5. The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

 

  a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

 

  b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

Date: July 24, 2009

 

/s/ Richard A. Flynt

Richard A. Flynt,
Chief Financial Officer (Principal Financial Officer)
EX-32.1 6 dex321.htm SECTION 906 CEO CERTIFICATION SECTION 906 CEO CERTIFICATION

Exhibit 32.1

Certification Pursuant to 18 U.S.C. 1350,

As Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

In connection with the Annual Report on Form 10-K for the period ended May 31, 2009 (the “Report”) of Immucor, Inc. (the “Registrant”), as filed with the Securities and Exchange Commission on the date hereof, I certify, to the best of my knowledge, that:

(1) The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and

(2) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Registrant.

 

July 24, 2009

 

/s/ Gioacchino De Chirico

  Gioacchino De Chirico
  Chief Executive Officer
EX-32.2 7 dex322.htm SECTION 906 CFO CERTIFICATION SECTION 906 CFO CERTIFICATION

Exhibit 32.2

Certification Pursuant to 18 U.S.C. 1350,

As Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

In connection with the Annual Report on Form 10-K for the period ended May 31, 2009 (the “Report”) of Immucor, Inc. (the “Registrant”), as filed with the Securities and Exchange Commission on the date hereof, I certify, to the best of my knowledge, that:

(1) The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and

(2) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Registrant.

 

July 24, 2009  

/s/ Richard A. Flynt

  Richard A. Flynt
  Chief Financial Officer
EX-99.1 8 dex991.htm SUMMARY OF LAWSUITS Summary of Lawsuits

Exhibit 99.1

Summary of Lawsuits

Warren General Hospital v. Immucor, Inc., Ortho-Clinical Diagnostics, Inc., and Johnson & Johnson Health Care Systems, Inc., United States District Court for the District of New Jersey, filed May 18, 2009

Bradford Hospital, d/b/a Bradford Regional Medical Center, v. Immucor, Inc., Ortho-Clinical Diagnostics, Inc., and Johnson & Johnson Health Care Systems, Inc., United States District Court for the District of New Jersey, filed May 21, 2009

Niagara Falls Memorial Medical Center v. Immucor, Inc., Ortho-Clinical Diagnostics, Inc., and Johnson & Johnson Health Care Systems, Inc., United States District Court for the District of New Jersey, filed May 22, 2009

Professional Resources Management, Inc., d/b/a Bullock County Hospital, v. Immucor, Inc., Ortho-Clinical Diagnostics, Inc., and Johnson & Johnson Health Care Systems, Inc., United States District Court for the District of New Jersey, filed May 27, 2009

Regional Medical Center Board, d/b/a Northeast Alabama Regional Medical Center, v. Immucor, Inc., Ortho-Clinical Diagnostics, Inc., and Johnson & Johnson Health Care Systems, Inc., United States District Court for the District of New Jersey, filed May 28, 2009

KershawHealth v. Immucor, Inc., Ortho-Clinical Diagnostics, Inc., and Johnson & Johnson Health Care Systems, Inc., United States District Court for the District of New Jersey, filed May 26, 2009

Professional Resource Management of Crenshaw LLC, d/b/a Crenshaw Community Hospital, v. Immucor, Inc., Ortho-Clinical Diagnostics, Inc., and Johnson & Johnson Health Care Systems, Inc., United States District Court for the District of New Jersey, filed May 26, 2009

Mary Hitchcock Memorial Hospital v. Immucor, Inc., Ortho-Clinical Diagnostics, Inc., and Johnson & Johnson Health Care Systems, Inc., United States District Court for the Southern District of New York, filed May 28, 2009

Larkin Community Hospital v. Immucor, Inc., Ortho-Clinical Diagnostics, Inc., and Johnson & Johnson Health Care Systems, Inc., United States District Court for the District of New Jersey, filed May 29, 2009

Schuylkill Medical Center—East Norwegian Street and Schuylkill Medical Center—South Jackson Street v. Immucor, Inc., Ortho-Clinical Diagnostics, Inc., and Johnson & Johnson Health Care Systems, Inc., United States District Court for the Eastern District of Pennsylvania, filed June 2, 2009

Seneca Medical Lab, Inc. v. Immucor, Inc., Ortho-Clinical Diagnostics, Inc., and Johnson & Johnson Health Care Systems, Inc., United States District Court for the Eastern District of Pennsylvania, filed June 3, 2009

F. Baragaño Pharmaceuticals v. Immucor, Inc., Ortho-Clinical Diagnostics, Inc., and Johnson & Johnson Health Care Systems, Inc., United States District Court for the Eastern District of Pennsylvania, filed June 5, 2009

Health Network Laboratories, L.P. v. Immucor, Inc., Ortho-Clinical Diagnostics, Inc., and Johnson & Johnson Health Care Systems, Inc., United States District Court for the District of New Jersey, filed June 11, 2009

Legacy Health System v. Immucor, Inc., Ortho-Clinical Diagnostics, Inc., and Johnson & Johnson Health Care Systems, Inc., United States District Court for the District of New Jersey, filed June 11, 2009

Titusville Area Hospital v. Immucor, Inc., Ortho-Clinical Diagnostics, Inc., and Johnson & Johnson Health Care Systems, Inc., United States District Court for the Eastern District of Pennsylvania, filed June 16, 2009

St. Mary’s Hospital, Decatur, of the Hospital Sisters of the Third Order of St. Francis v. Immucor, Inc., Ortho-Clinical Diagnostics, Inc., and Johnson & Johnson Health Care Systems, Inc., United States District Court for the Eastern District of Texas, filed June 26, 2009

Highlands Hospital v. Immucor, Inc., Ortho-Clinical Diagnostics, Inc., and Johnson & Johnson Health Care Systems, Inc., United States District Court for the Eastern District of Pennsylvania, filed June 26, 2009

St. Barnabas Hospital, Inc. a/k/a St. Barnabas Hospital v. Immucor, Inc., Ortho-Clinical Diagnostics, Inc., and Johnson & Johnson Health Care Systems, Inc., United States District Court for the Eastern District of Pennsylvania, filed July 2, 2009


Exhibit 99.1

St. Anthony’s Memorial Hospital, of the Hospital Sisters of the Third Order of St. Francis v. Immucor, Inc., Ortho-Clinical Diagnostics, Inc. and Johnson & Johnson Healthcare Systems, Inc., United States District Court for the Eastern District of Texas, filed July 6, 2009

St. Francis Hospital, of the Hospital Sisters of the Third Order of St. Francis v. Immucor, Inc., Ortho-Clinical Diagnostics, Inc. and Johnson & Johnson Healthcare Systems, Inc., United States District Court for the Eastern District of Texas, filed July 6, 2009

Sacred Heart Hospital of the Order of the Hospital Sisters of the Third Order of St. Francis v. Immucor, Inc., Ortho-Clinical Diagnostics, Inc. and Johnson & Johnson Healthcare Systems, Inc., United States District Court for the District of South Carolina, filed July 6, 2009

St. John’s Hospital of the Third Order of St. Francis v. Immucor, Inc., Ortho-Clinical Diagnostics, Inc. and Johnson & Johnson Healthcare Systems, Inc., United States District Court for the Eastern District of Texas, filed July 7, 2009

St. Mary’s Hospital, Streator, of the Hospital Sisters of the Third Order of St. Francis v. Immucor, Inc., Ortho-Clinical Diagnostics, Inc. and Johnson & Johnson Healthcare Systems, Inc., United States District Court for the Eastern District of Texas, filed July 7, 2009

St. Joseph’s Hospital, Breese, of the Hospital Sisters of the Third Order of St. Francis v. Immucor, Inc., Ortho-Clinical Diagnostics, Inc. and Johnson & Johnson Healthcare Systems, Inc., United States District Court for the Western District of Pennsylvania, filed July 7, 2009

St. Mary’s Hospital Medical Center of Green Bay, Inc. v. Immucor, Inc., Ortho-Clinical Diagnostics, Inc. and Johnson & Johnson Healthcare Systems, Inc., United States District Court for the District of New Jersey, filed July 8, 2009

St. Nicholas Hospital of the Hospital Sisters of the Third Order of St. Francis v. Immucor, Inc., Ortho-Clinical Diagnostics, Inc. and Johnson & Johnson Healthcare Systems, Inc., United States District Court for the Eastern District of Pennsylvania, filed July 9, 2009

St. Vincent Hospital of the Hospital Sisters of the Third Order of St. Francis v. Immucor, Inc., Ortho-Clinical Diagnostics, Inc. and Johnson & Johnson Healthcare Systems, Inc., United States District Court for the Eastern District of Wisconsin, filed July 9, 2009

St. Joseph’s Hospital of the Hospital Sisters of the Third Order of St. Francis v. Immucor, Inc., Ortho-Clinical Diagnostics, Inc. and Johnson & Johnson Healthcare Systems, Inc., United States District Court for the Eastern District of Tennessee, filed July 8, 2009

St. Elizabeth’s Hospital of the Hospital Sisters of the Third Order of St. Francis v. Immucor, Inc., Ortho-Clinical Diagnostics, Inc. and Johnson & Johnson Healthcare Systems, Inc., United States District Court for the Southern District of Illinois, filed July 9, 2009

St. Joseph’s Hospital of the Hospital Sisters of the Third Order of St. Francis v. Immucor, Inc., Ortho-Clinical Diagnostics, Inc. and Johnson & Johnson Healthcare Systems, Inc., United States District Court for the Southern District of California, filed July 16, 2009

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-----END PRIVACY-ENHANCED MESSAGE-----