Form 10-Q
Table of Contents

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 10-Q

 

 

 

x Quarterly Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

For the quarterly period ended March 31, 2009

or

 

¨ Transition Report Pursuant Section 13 or 15(d) of the Securities Exchange Act of 1934

For the transition period from                      to                     .

Commission file number 1-11181

 

 

IRIS INTERNATIONAL, INC.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   94-2579751
(State or other jurisdiction of
incorporation or organization)
  (I.R.S. Employer
Identification No.)

9172 Eton Avenue

Chatsworth, California 91311

(Address of principal executive offices, zip code)

(818) 709-1244

(Registrant’s telephone number, including area code)

 

 

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 Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 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 check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer,” and “smaller reporting company” in Rule 12b-2 of the Exchange Act.

 

Large accelerated filer   ¨   Accelerated filer   x
Non-accelerated filer   ¨  (Do not check if a smaller reporting company)   Smaller reporting company   ¨

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

As of May 1, 2009, the issuer had 17,929,596 shares of common stock issued and outstanding.

 

 

 


Table of Contents

IRIS INTERNATIONAL, INC.

INDEX TO FORM 10-Q

 

          Page
PART I    FINANCIAL INFORMATION    3
Item 1.    Financial Statements   
   Consolidated Balance Sheets as of March 31, 2009 (unaudited) and December 31, 2008    3
   Consolidated Statements of Income for the three months ended March 31, 2009 and 2008 (unaudited)    4
   Consolidated Statements of Cash Flows for the three months ended March 31, 2009 and 2008 (unaudited)    5
   Notes to Consolidated Financial Statements    6
Item 2.    Management’s Discussion and Analysis of Financial Condition and Results of Operations    12
Item 3.    Quantitative and Qualitative Disclosures About Market Risk    18
Item 4.    Controls and Procedures    19
PART II    OTHER INFORMATION    20
Item 1A.    Risk Factors    20
Item 2.    Unregistered Sales of Equity Securities and Use of Proceeds    20
Item 6.    Exhibits    20
Signatures       21

 

2


Table of Contents

PART I: FINANCIAL INFORMATION

 

Item 1. Financial Statements

IRIS INTERNATIONAL, INC.

CONSOLIDATED BALANCE SHEETS

(in thousands)

 

      March 31,
2009
    December 31,
2008
 
     (unaudited)        

Assets

    

Current assets:

    

Cash and cash equivalents

   $ 26,745     $ 24,445  

Short-term investments in marketable securities

     —         2,157  

Accounts receivable, net of allowance for doubtful accounts and sales returns of $400 and $445

     17,156       20,261  

Inventories

     13,138       9,957  

Prepaid expenses and other current assets

     860       2,512  

Investment in sales-type leases

     3,345       3,204  

Deferred tax asset

     3,757       3,727  
                

Total current assets

     65,001       66,263  
                

Property and equipment, net of accumulated depreciation of $9,546 and $8,923

     9,620       9,678  

Goodwill

     2,450       2,450  

Core technology, net of accumulated amortization of $268 and $254

     1,522       1,544  

Software development costs, net of accumulated amortization of $3,112 and $2,322

     2,366       2,291  

Deferred tax asset

     1,535       1,811  

Investment in sales-type leases

     5,719       5,957  

Other assets

     666       644  
                

Total assets

   $ 88,879     $ 90,638  
                

Liabilities and Stockholders’ Equity

    

Current liabilities:

    

Accounts payable

   $ 6,658     $ 6,299  

Accrued expenses

     5,137       6,475  

Deferred service contract revenue, current portion

     1,977       1,936  
                

Total current liabilities

     13,772       14,710  

Deferred service contract revenue, long-term

     16       18  
                

Total liabilities

     13,788       14,728  

Commitments and contingencies

    

Shareholders’ equity:

    

Common stock, $.01 par value; Authorized: 50 million shares; Issued and outstanding: 17,900 shares and 18,036 shares

     179       180  

Preferred Stock, $.01 par value; authorized 1.0 million shares: Callable Series C shares issued and outstanding: none

     —         —    

Additional paid-in capital

     82,881       83,646  

Other comprehensive income

     102       415  

Accumulated deficit

     (8,071 )     (8,331 )
                

Total shareholders’ equity

     75,091       75,910  
                

Total liabilities and shareholders’ equity

   $ 88,879     $ 90,638  
                

The accompanying notes are an integral part of these consolidated financial statements.

 

3


Table of Contents

IRIS INTERNATIONAL, INC.

CONSOLIDATED STATEMENTS OF INCOME

(unaudited – in thousands)

 

     For the three months
ended March 31,
 
     2009     2008  

Sales of IVD instruments

   $ 5,453     $ 7,355  

Sales of IVD consumables and service

     12,522       10,855  

Sales of sample processing instruments and supplies

     3,600       3,397  
                

Total revenues

     21,575       21,607  
                

Cost of goods - IVD instruments

     3,136       3,556  

Cost of goods - IVD consumables and service

     4,912       4,786  

Cost of goods - sample processing instruments and supplies

     1,832       1,661  
                

Total cost of goods sold

     9,880       10,003  
                

Gross profit

     11,695       11,604  
                

Marketing and selling

     3,884       3,850  

General and administrative

     3,147       2,772  

Research and development, net

     2,809       2,620  
                

Total operating expenses

     9,840       9,242  
                

Operating income

     1,855       2,362  

Other income (expense):

    

Interest income

     203       341  

Interest expense

     (4 )     (2 )

Other (expense) income

     (7 )     9  
                

Income before provision for income taxes

     2,047       2,710  

Provision for income taxes

     655       889  
                

Net income

   $ 1,392     $ 1,821  
                

Net income per share – basic

   $ 0.08     $ 0.10  
                

Net income per share – diluted

   $ 0.08     $ 0.10  
                

Weighted average number of common shares outstanding – basic

     17,609       18,436  
                

Weighted average number of common shares outstanding – diluted

     17,800       19,063  
                

 

The accompanying notes are an integral part of these consolidated financial statements.

 

4


Table of Contents

IRIS INTERNATIONAL, INC.

CONSOLIDATED STATEMENTS OF CASH FLOWS

(unaudited – in thousands)

 

     For the three months
ended March 31,
 
     2009     2008  

Cash flows from operating activities:

    

Net income

   $ 1,392     $ 1,821  

Adjustments to reconcile net income to net cash provided by operations:

    

Deferred taxes

     —         685  

Loss on disposal of fixed assets

     39       —    

Excess tax expense (benefit) from stock based payout arrangement

     246       (381 )

Depreciation and amortization

     816       781  

Common stock and stock based compensation

     879       509  

Changes in operating assets and liabilities:

    

Accounts receivable

     3,105       1,259  

Inventories

     (3,181 )     (2,980 )

Prepaid expenses and other current assets

     1,652       (193 )

Investment in sales-type leases

     97       204  

Other assets

     (22 )     (64 )

Accounts payable

     359       1,526  

Accrued expenses

     (1,338 )     (1,515 )

Deferred service contract revenue

     39       95  
                

Net cash provided by operating activities

     4,083       1,747  
                

Cash flows from investing activities:

    

Acquisition of property and equipment

     (637 )     (694 )

Software development costs capitalized

     (213 )     (268 )

Sale of short term investments in marketable securities

     2,157       —    
                

Net cash provided by (used in) investing activities

     1,307       (962 )
                

Cash flows from financing activities:

    

Issuance of common stock and warrants for cash

     25       634  

Repurchase of common stock

     (2,556 )     (5,004 )

Tax benefit from stock option exercises

     (246 )     381  
                

Net cash used in financing activities

     (2,777 )     (3,989 )
                

Effect of exchange rate changes on cash and cash equivalents

     (313 )     213  
                

Net increase (decrease) in cash and cash equivalents

     2,300       (2,991 )

Cash and cash equivalents at beginning of period

     24,445       28,145  
                

Cash and cash equivalents at end of period

   $ 26,745     $ 25,154  
                

Supplemental schedule of non-cash financing activities:

    

During the three months ended March 31, 2009, the Company disposed of property and equipment with a cost and accumulated depreciation of $67 and $28, respectively.

    

Supplemental disclosure of cash flow information:

    

Cash paid for income taxes

     177       68  

Cash paid for interest

     4       2  

The accompanying notes are an integral part of these consolidated financial statements.

 

5


Table of Contents

IRIS INTERNATIONAL, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

 

1. Company History

IRIS International, Inc. was incorporated in California in 1979 and reincorporated during 1987 in Delaware. The Company designs, develops, manufactures and markets in vitro diagnostic, (“IVD”) products, including IVD imaging systems based on patented and proprietary neural network-based Automated Particle Recognition (APR™) software to enable high-speed digital processing to classify and display images and describe the morphology of microscopic particles, urine chemistry analyzer and related chemistry test strips and accessories, molecular diagnostics assays based on the Company’s Nucleic Acid Detection Immuno-Assay (NADiA) technology, as well as special purpose centrifuges and other small instruments for automating microscopic procedures and DNA processing performed in clinical laboratories.

 

2. Interim Financial Reporting

Basis of Presentation – The financial statements have been prepared in accordance with the instructions to Form 10-Q under the Securities Exchange Act of 1934, as amended, and do not include all of the information and note disclosures required by accounting principles generally accepted in the United States of America (“GAAP”). These financial statements should be read in conjunction with the Consolidated Financial Statements and accompanying notes contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2008.

The Consolidated Financial Statements included herein are unaudited, but in the opinion of management, such financial statements include all adjustments, consisting only of normal recurring adjustments, necessary to summarize fairly the Company’s financial position and results of operations for the interim period. The results reported in these Consolidated Financial Statements should not be taken as indicative of results that may be expected for the entire year.

Use of Estimates – The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting periods. The significant estimates in the preparation of the consolidated financial statements relate to the assessment of the carrying allowance for doubtful accounts, inventory reserves, the useful lives, fair value and recoverability of carrying value of long-lived and intangible assets, including goodwill, unearned income on sales-type leases, estimated provisions for warranty costs, laboratory information system implementations and deferred tax assets. Actual results and outcomes may differ from management’s estimates and assumptions.

Earnings Per Share – The Company computes and presents earnings per share in accordance with SFAS No. 128, “Earnings per share.” Basic earnings per share are computed by dividing net income by the weighted average number of common shares outstanding. Diluted earnings per share is computed by dividing net income by the weighted average number of common shares and common stock equivalents outstanding, calculated on the treasury stock method for options and warrants using the average market prices during the period. The weighted average number of outstanding antidilutive common stock options and warrants excluded from the computation of diluted net income per common share for the three months ended March 31, 2009 and 2008 was $1,488,000 and 513,000, respectively. A reconciliation of the shares used in the basic and diluted earnings per common share is as follows:

 

6


Table of Contents

IRIS INTERNATIONAL, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — continued

 

     For the three months
ended March 31,
(in thousands)    2009    2008

Basic weighted shares outstanding

   $ 17,609    $ 18,436

Dilutive stock options & warrants

     191      627
             

Diluted weighted shares outstanding

   $ 17,800    $ 19,063
             

Foreign Currency Hedge – The Company conducts business in certain foreign markets, primarily in the European Union and Asia. To mitigate the potential impact of adverse fluctuations in the U.S. Dollar exchange rate for these currencies, the Company periodically purchases foreign currency forward contracts. The Company does not speculate in these hedging instruments in order to profit from foreign currency exchanges; nor does the Company enter into trades for which there are no underlying exposures.

Under Statement of Financial Accounting Standards (“SFAS”) No. 133, Accounting for Derivative Instruments and Hedging Activities, the Company documents all relationships between hedging instruments and hedged items, as well as its risk management objective for undertaking these hedging transactions. This process includes relating the forward contracts that are designated as fair value or cash flow hedges to specific assets and liabilities on the balance sheet or to specific firm commitments or forecasted transactions. The Company also formally assesses, both at the inception of the hedge and on an ongoing basis, whether each derivative is highly effective in offsetting changes in fair values or cash flows of the hedged items.

At March 31, 2009 and 2008, the Company did not have any foreign currency forward contracts outstanding in Japanese Yen or Euros.

 

3. Investments in Marketable Securities

In 2008, we adopted SFAS no. 157, “Fair Value Measurement” (SFAS 157), for assets and liabilities measured at fair value on a recurring basis. SFAS 157, defines fair values as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. SFAS 157 establishes a fair value hierarchy, which prioritizes the inputs used in measuring fair value into three broad levels as follows:

 

   

Level 1 inputs are quoted prices (unadjusted) in active markets for identical assets or liabilities that the reporting entity has the ability to access at the measurement date.

 

   

Level 2 inputs include quoted prices for similar assets or liabilities in active markets, quoted prices for identical or similar assets or liabilities in markets that are not active, inputs other than the quoted process that are observable for the asset or liability and inputs that are derived principally from or corroborated by observable market data by correlation or other means.

 

   

Level 3 inputs are unobservable inputs for the asset or liability.

At March 31, 2009, the Company did not hold any investments in marketable securities.

At December 31, 2008, the Company’s investments in marketable securities primarily include highly liquid government securities and an auction rate security. These securities are carried at cost which approximates fair value due to their highly liquid nature. Of the $2,157 carrying value of investments at December 31, 2008, and in accordance with the fair value hierarchy contained in SFAS 157, $1,857 was valued using quoted prices in active markets for identical assets or liabilities (Level 1) and approximately $300 was valued using significant unobservable inputs (Level 3) such as current results, trends and future prospects, capital market conditions, and other economic factors.

The following table presents the estimated fair value of the Company’s investment in marketable securities at December 31, 2008.

 

     Cost    Unrealized
Gains
   Unrealized
Losses
   Fair
Value
(In thousands)                    

Auction rate security

   $ 300    $ —      $ —      $ 300

Government securities

     1,857      —        —        1,857
                           
   $ 2,157    $ —      $ —      $ 2,157
                           

 

7


Table of Contents

IRIS INTERNATIONAL, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — continued

 

The Company’s investment in the auction rate security was tied to short-term interest rates that are periodically reset through an auction process. The auction process resets the applicable interest rates at prescribed calendar intervals and is intended to provide liquidity to the holders of auction rate securities by matching buyers and sellers in a market context, enabling the holders to gain immediate liquidity by selling such securities at par, or rolling over their investment. If there is an imbalance between buyers and sellers, there is a risk of a failed auction. Throughout 2008, auctions relating to those types of auction rate securities failed. An auction failure is not a default. As of December 31, 2008, the Company’s investment was carried at par value as the Company believed the investment approximated full value based upon comparable and similar investments. In October 2008, Citigroup Inc. reached an agreement with state and federal regulators to buy back at par value all auction rate securities from its retail customers. Due to this settlement, the Company’s brokerage company announced that beginning on January 15, 2009 they would purchase auction rate securities at par value. In March 2009, the Company sold its auction rate security at full value and no impairment charge was recognized at the time of sale.

For the three months ended March 31, 2009 and year ended December 31, 2008, there were no impairment losses on the Company’s available for sale marketable securities. Based on the Company’s assessment of the credit quality of the underlying collateral and credit support available to each of the securities in which it invested, it believed that nothing other then temporary impairment had occurred, as the Company had the ability to hold these investments long enough to avoid realizing any significant loss.

 

4. Inventories

Inventories consist of the following:

 

(in thousands)    March 31,
2009
   December 31,
2008

Finished goods

   $ 3,832    $ 2,234

Work-in-process

     239      270

Raw materials, parts and sub-assemblies

     9,067      7,453
             

Inventories

   $ 13,138    $ 9,957
             

 

5. Sales-type Leases

The components of net investment in sales-type leases consist of the following:

 

(in thousands)    March 31,
2009
    December 31,
2008
 

Total minimum lease payments

   $ 10,344     $ 10,380  

Less: unearned income

     (1,280 )     (1,219 )
                

Net investment in sales-type leases

     9,064       9,161  

Less: current portion

     (3,345 )     (3,204 )
                

Net investment in sales-type leases, non-current portion

   $ 5,719     $ 5,957  
                

Future minimum lease payments due from customers under sales-type leases for each of the five succeeding years:

 

(In thousands)     

Year Ending December 31,

  

2009 (Nine months remaining)

   $ 2,416

2010

     2,655

2011

     1,849

2012

     1,270

2013

     747

Thereafter

     127
      
   $ 9,064
      

 

8


Table of Contents

IRIS INTERNATIONAL, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — continued

 

6. Bank Loan Agreement

The Company has a credit facility with a commercial bank. The credit facility consists of a $6.5 million revolving line of credit for working capital and a $10.0 million line of credit for acquisitions and product opportunities. The credit facility has variable interest rates, which will change from time to time based on changes to either the LIBOR rate or the lender’s prime rate. Borrowings under the credit facility are secured by all of the Company’s assets and mature in June 2010 and June 2015, respectively.

As of March 31, 2009 and 2008, there were no borrowings under the credit facility. The Company, however, is subject to certain financial and non-financial covenants under the credit facility with the bank and as of March 31, 2009, the Company was in compliance with these covenants.

 

7. Income Taxes

On a quarterly basis, the Company estimates what its effective tax rate will be for the full fiscal year and records a quarterly income tax provision based on the anticipated rate. As the year progresses, the Company refines its estimate based on the facts and circumstances by each tax jurisdiction. The effective tax rates for the three months ended March 31, 2009 and 2008 were 32% and 33%, respectively.

The Company adopted the provisions of Financial Accounting Standards Board (“FASB”) Interpretation No. 48, Accounting for Uncertainty in Income Taxes-an Interpretation of FASB Statement 109 (“FIN 48”), on January 1, 2007.

The Company will recognize potential interest and penalties related to income tax positions as a component of the provision for income taxes on the consolidated statements of income in any futures periods in which the Company must record a liability. Since the Company has not recorded a liability at March 31, 2009, there would be no impact to the Company’s effective tax rate.

 

8. Stock-Based Compensation

The Company accounts for stock-based compensation pursuant to Statement of Financial Accounting Standards No. 123R (“SFAS 123R”), “Share-Based Payment,” which requires compensation costs related to share-based transactions, including employee stock options, to be recognized in the financial statements based on fair value. Share-based compensation expense for the three months ended March 31, 2009 and 2008 includes incremental share-based compensation expense as follows:

 

     For the three
months ended
March 31,
 
(in thousands)    2009     2008  

Cost of sales

   $ 92     $ 76  

Marketing and selling

     134       83  

General and administrative

     512       232  

Research and development

     141       118  
                

Stock-based compensation

   $ 879     $ 509  
                

Income tax benefit

   $ (352 )   $ (203 )
                

Stock Options

Stock option activity during the three months ended March 31, 2009 is as follows:

 

(in thousands, except for per share amounts)    Shares     Weighted
Average
Exercise
Price Per
Share
   Weighted
Average
Remaining
Contractual
Term
   Aggregate
Intrinsic
Value

Outstanding at January 1, 2009

   1,974     $ 13.24    3.3 years    $ 5,310

Granted

   401     $ 9.99      

Exercised

   (8 )   $ .84      

Canceled or expired

   (93 )   $ 14.01      
              

Outstanding at March 31, 2009

   2,274     $ 12.67    3.7 years    $ 3,085
              

Exercisable at March 31, 2009

   1,218     $ 13.10    2.8 years    $ 2,457
              

 

9


Table of Contents

IRIS INTERNATIONAL, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — continued

 

The aggregate intrinsic value in the table above represents the total pretax intrinsic value (the difference between our closing stock price on March 31, 2009 and the exercise price, multiplied by the number of in-the-money options) that would have been received by the option holders, had all option holders exercised their options on March 31, 2009. Total intrinsic value of options exercised for the three months ended March 31, 2009 amounted to $52,000. As of March 31, 2009, total unrecognized stock-based compensation expense related to unvested stock options was $4,016,000.

The Compensation Committee of the Company’s board of directors determines the exercise price of options. Payment of the exercise price may be made either in cash or with shares of common stock that have been held at least six months. The options generally vest over four years and expire between five to ten years from the date of grant. The fair value of each option grant is estimated on the date of the grant using the Black-Scholes option pricing model with the following weighted average assumptions:

 

     For the three
months ended
March 31,
 
     2009     2008  

Risk free interest rate

   1.9 %   2.5 %

Expected lives (years)

   4.0     3.0  

Expected volatility

   59.7 %   47 %

Expected dividend yield

   —       —    

The expected volatilities are based on the historical volatility of our stock. The observation is made on a weekly basis. The expected terms of the stock options are based on the average vesting period on a basis consistent with the historical experience for similar option grants. The risk-free rate is consistent with the expected terms of the stock options and based on the U.S. Treasury yield curve in effect at the time of grant. The Company estimates forfeitures rates based on historical data.

A summary of our non-vested stock options during the three months ended March 31, 2009 is presented below:

 

(In thousands except for fair value per share)    Shares     Weighted
Average
Grant Date
Fair Value
Per Share

Non-vested options at January 1, 2009

   856     $ 13.48

Granted

   401     $ 9.99

Vested

   (159 )   $ 13.67

Forfeited or expired

   (41 )   $ 12.13
        

Non-vested options at March 31, 2009

   1,057     $ 12.18
        

Restricted Shares

The Company began awarding restricted shares of its common stock since 2006. Restricted shares currently vest 25% after one year and 6 1/4% quarterly thereafter. Unvested restricted shares are forfeited if the recipient’s employment terminates for any reason other than death, disability or special circumstances as determined by the Compensation Committee of the Company’s board of directors. Restricted shares activity during the three months ended March 31, 2009 is as follows:

 

(in thousands, except for fair value per share)    Shares     Weighted
Average
Grant Date
Fair Value
Per Share

Non-vested shares at January 1, 2009

   202     $ 13.81

Granted

   116     $ 9.99

Vested

   (28 )   $ 12.91

Forfeited during period

   (4 )   $ 14.44
        

Non-vested shares at March 31, 2009

   286     $ 12.33
        

 

10


Table of Contents

IRIS INTERNATIONAL, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — continued

 

Fair value of our restricted shares is based on our closing stock price on the date of grant. As of March 31, 2009, total unrecognized stock-based compensation expense related to non vested restricted share grants was $2,804,000 which is expected to be recognized over the remaining weighted average period of approximately 2.3 years.

 

9. Capital Stock – Warrants

At March 31, 2009, there were outstanding and exercisable warrants to purchase 74,300 shares at a price of $7.80 per share. These warrants are exercisable and will expire April 23, 2009. Subsequently, 24,016 warrants were exercised prior to the expiration.

 

10. Common Stock Repurchase Plan

On March 3, 2008, the Company’s board of directors authorized a share repurchase and retirement plan of up to $15 million of the Company’s common stock over a 12-month period. Under this plan the Company repurchased 492,068 shares of our common stock for approximately $5.7 million. On July 25, 2008, the Company’s board of directors terminated the share repurchase and retirement plan.

On November 21, 2008, the Company’s board of directors authorized a share repurchase and retirement plan of up to $10 million of the Company’s common stock over a 12-month period. During the three months ended March 31, 2009, the Company repurchased 250,800 shares of common stock for approximately $2.5 million. As of March 31, 2009, under this plan, the Company had repurchased a cumulative total of 742,311 shares of common stock for approximately $8.7 million.

 

11. Contingencies

Litigation

From time to time, the Company is party to certain litigation arising in the normal course of business. Management believes that the resolution of such matters will not have a material adverse effect on our financial position, results of operations or cash flows.

Guarantees

The Company enters into indemnification provisions under (i) agreements with other companies in the ordinary course of business, typically with business partners, contractors, customers and landlords, and (ii) agreements with investors. Under such provisions, the Company generally indemnifies and holds harmless the indemnified party for losses suffered or incurred by the indemnified party as a result of the Company’s activities or, in some cases, as a result of the indemnified party’s activities under the agreement. These indemnification provisions often include indemnifications relating to representations made by the Company with regard to intellectual property rights. These indemnification provisions generally survive termination of the underlying agreement. In addition, in some cases, the Company agrees to reimburse employees for certain expenses and to provide salary continuation during short-term disability. The maximum potential amount of future payments the Company could be required to make under these indemnification provisions is unlimited. The Company reviews its exposure under these agreements no less than annually, or more frequently when events indicate. As a result, the Company believes the estimated fair value of these agreements is minimal. Accordingly, the Company has no recorded liabilities for these agreements as of December 31, 2008 or March 31, 2009.

 

12. Segments and Geographic Information

The Company’s operations are organized on the basis of products and related services and under SFAS No. 131, the Company operates in two segments: (1) IVD and (2) sample processing.

The IVD segment designs, develops, manufactures, markets and distributes in-vitro diagnostic systems based on patented and proprietary technology for automating microscopic and clinical chemistry procedures for urinalysis. The segment also provides ongoing sales of consumables and services necessary for the operation of installed urinalysis workstations. In the United States, these products are mostly sold through a direct sales and service force. Internationally, these products are sold and serviced through distributors, with the exception of France and Puerto Rico. The segment also includes the operations of the Company’s Iris Molecular Diagnostics, or IMD, subsidiary.

The sample processing segment designs, develops, manufactures and markets a variety of benchtop centrifuges, small instruments and supplies. These products are used primarily for manual specimen preparation and dedicated applications in coagulation, cytology, hematology urinalysis and DNA processing. These products are sold worldwide through distributors.

 

11


Table of Contents

The accounting policies of the segments are the same as those described in the “Summary of Significant Accounting Policies” in the Company’s Annual Report on Form 10-K. The Company evaluates the performance of its segments and allocates resources to them based on earnings before income taxes, excluding corporate charges.

The tables below present information about reported segments for the three months ended March 31, 2009 and 2008:

 

(In thousands)    IVD    Sample
Processing
   Unallocated
Corporate
Expenses
    Total

For the three months March 31, 2009

          

Revenues

   $ 17,975    $ 3,600    $ —       $ 21,575

Interest income

     197      6      —         203

Interest expense

     4      —        —         4

Depreciation and amortization

     745      67      4       816

Segment pre-tax profit

     2,458      976      (1,387 )     2,047

Segment assets

     58,791      24,796      5,292       88,879

Investment in long-lived assets

     25,304      384      —         25,688

For the three months March 31, 2008

          

Revenues

   $ 18,210    $ 3,397    $ —       $ 21,607

Interest income

     341      —        —         341

Interest expense

     2      —        —         2

Depreciation and amortization

     714      63      4       781

Segment pre-tax profit

     2,538      923      (751 )     2,710

Segment assets

     58,620      19,799      6,633       85,052

Investment in long-lived assets

     23,950      432      —         24,382

The Company ships products from two locations in the United States and one location in Germany. Substantially all long-lived assets are located in the United States. Sales to international customers amounted to approximately $6.8 million during the first quarter of 2009 compared to $7.7 million during the first quarter of 2008.

Segment assets attributed to corporate unallocated expenses are deferred taxes. Long-lived assets include property and equipment, intangible assets, long-term portion of inventory and other long-term assets. Deferred income tax is excluded from long-lived assets.

 

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

Overview

IRIS International, Inc. (the “Company”) consists of three operating units in two business segments as determined in accordance with SFAS 131. Our in-vitro diagnostics, or IVD, segment also called Iris Diagnostics Division, designs, manufactures and markets IVD systems, consumables and supplies for urinalysis and body fluids. With the acquisition of Leucadia Technologies, Inc., or Leucadia, in 2006 we created our Iris Molecular Diagnostics, or IMD, subsidiary whose operations are included as part of the Iris Diagnostics Division. Our Sample Processing segment markets small centrifuges and other processing equipment and accessories for rapid specimen processing.

The initial applications for our technology have been in the urinalysis market and we are the leading worldwide provider of urine microscopy systems, with an installed base of over 2,200 systems in over 50 countries. We generate revenues primarily from: sales of IVD instruments, IVD consumables and service and sample processing instruments and supplies. Revenues from IVD instruments include sales of urine microscopy and chemistry analyzers manufactured by us and urine chemistry analyzers sourced from a Japanese manufacturer. We sell our urine microscopy analyzers worldwide and the iChem®VELOCITY™, our fully-automated chemistry analyzer internationally since September 2008. We currently distribute the Japanese manufacturer’s fully automated chemistry analyzers domestically, but upon clearance of our 510(k) pending with the FDA for our iChem VELOCITY, we will begin selling our chemistry analyzer in the United States. Consumables include products such as chemical reagents and urine test strips. Service revenues are derived primarily from annual service contracts purchased by our domestic customers after the initial year of sale, which is covered by product warranty and spare parts purchased by international customers. Once the analyzers are installed, we generate recurring revenue from sales of consumables. Consumable and service revenue should continue to expand as the installed base of related instruments increases. Revenue is also generated from sales of sample processing instruments and related supplies, which primarily consists of centrifuge systems, DNA processing workstations and blood analysis products.

 

12


Table of Contents

During the first quarter of 2009, we decided to delay international shipments of the iChem VELOCITY chemistry analyzer, in order to implement product improvements based on customer feedback during the early stages of the product launch. As a result, international sales of the iChem VELOCITY and the iRICELL™ integrated urinalysis workstations, which includes our iQ®200 microscopy analyzer, were adversely affected during the quarter. We carried a $1.2 million backlog in iChem VELOCITY and iRICELL sales at March 31, 2009, which backlog has increased in April 2009. The necessary product improvements have now been implemented and we anticipate resuming full-scale shipments against our backlog of iChem VELOCITY analyzers and iRICELL workstations during May 2009.

Domestic sales of our urinalysis systems are direct to the customer through our sales force. International sales, with the exception of France and Puerto Rico where sales are direct to end use customers, are through independent distributors. International sales represented 32% of consolidated revenues during the first quarter of 2009 as compared to 36% during the first quarter of 2008. Since international sales are made through independent distributors, gross profit margin is lower than domestic sales of the same products, but we do not incur sales and marketing costs for such sales. Our Sample Processing products are sold worldwide primarily through distributors.

We have introduced a new commercial name, NADiA®ProsVue™, to clearly differentiate our NADiA PSA assay from routine screening PSA assays. We met with the U.S. Food and Drug Administration, or FDA, to review a NADiA ProsVue™ Pre-Investigational Device Exemption (Pre-IDE) submission and reached an agreement in principle on the product claim and clinical end points to be used in a clinical study. In March 2009, the Company submitted a second Pre-IDE incorporating the results of the first stage of the referenced clinical study and refined the proposed prognostic claim. In April 2009, the FDA reviewed and commented on the second Pre-IDE submission and we are incorporating the final recommendations from this second FDA review into our retrospective clinical study before initiating a larger multi-center study, which is expected to be completed and submitted with an FDA 510(k) application in the mid-Summer of 2009.

Critical Accounting Policies

The preparation of financial statements and related disclosures in conformity with U.S. generally accepted accounting principles and our discussion and analysis of our financial condition and results of operations require us to make judgments, assumptions, and estimates that affect the amounts reported in our condensed consolidated financial statements and accompanying notes. We base our estimates on historical experience and on various other assumptions we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities. We regularly discuss with our audit committee the basis of our estimates. Actual results may differ from these estimates and such differences may be material.

A description of our critical accounting policies that represent the more significant judgments and estimates used in the preparation of our financial statements was provided in the Management’s Discussion and Analysis of Financial Condition and Results of Operations section of our Annual Report on Form 10-K for the year ended December 31, 2008. There have been no material changes in theses critical accounting policies since December 2008.

 

13


Table of Contents

Results of Operations

The following table summarizes results of operations data for the periods indicated. The percentages in the table are based on total revenues with the exception of percentages for gross profit margins, which are computed on related revenue, and income taxes, which are based on income before income taxes.

 

     Three months ended
March 31,
 
(in thousands)    2009          2008       

Revenues

          

IVD instruments

   $ 5,453    25 %   $ 7,355    34 %

IVD consumables and service

     12,522    58 %     10,855    50 %

Sample Processing instruments and supplies

     3,600    17 %     3,397    16 %
                  

Total revenues

     21,575    100 %     21,607    100 %
                  

Gross profit (1)

          

IVD instruments

     2,317    42 %     3,799    52 %

IVD consumable and service

     7,610    61 %     6,069    56 %

Sample Processing instruments and supplies

     1,768    49 %     1,736    51 %
                  

Gross profit

     11,695    54 %     11,604    54 %
                  

Operating expenses

          

Marketing and selling

     3,884    18 %     3,850    18 %

General and administrative

     3,147    15 %     2,772    13 %

Research and development, net

     2,809    13 %     2,620    12 %
                  

Total operating expenses

     9,840    46 %     9,242    43 %
                  

Operating income

     1,855    9 %     2,362    11 %

Other income (expense)

     192        348   
                  

Income before income taxes

     2,047    9 %     2,710    13 %

Income taxes (2)

     655    32 %     889    33 %
                  

Net income

   $ 1,392    6 %   $ 1,821    8 %
                  

 

(1) Gross profit margin percentages are based on the related sales of each category.

 

(2) Income tax percentage is computed based on the relationship of income taxes to pre-tax income.

Comparison of Three Months Ended March 31, 2009 to 2008

Consolidated revenues for the three months ended March 31, 2009 were essentially flat versus the prior year quarter. Revenues in the IVD urinalysis segment decreased 1% to $18 million in the first quarter of 2009 from $18.2 million in the prior year quarter. Sales of IVD instruments decreased 26% to $5.5 million in the first quarter of 2009 from $7.4 million in the prior year quarter. The decrease in IVD instrument sales is primarily attributable to a reduction in international sales due to our decision in the first quarter of 2009 to delay shipments of our recently launched iChem VELOCITY chemistry analyzer to implement product improvements. The delay also resulted in reduced international shipments during the quarter of our iQ200 microscopy analyzer, which is combined with the iChem VELOCITY chemistry analyzer to form the iRICELL integrated urinalysis workstation. At March 31, 2009, we had a $1.2 million backlog in iChem VELOCITY and iRICELL sales, which backlog increased during April 2009. We anticipate resuming full-scale shipments against our backlog of iChem VELOCITY analyzers and iRICELL workstations during May 2009.

Revenues from IVD consumables and service increased 15% to a record $12.5 million in the first quarter of 2009 as compared to $10.9 million in the prior year quarter. The increase was driven primarily due to the larger installed base of instruments and the success of converting expiring warranty agreements to service agreements. Revenues from sample processing instruments and supplies increased 6% to $3.6 million in the first quarter of 2009 as compared to $3.4 million in the prior year quarter. The increase was primarily driven by the new Express 4 centrifuge and OEM sales to IDEXX labs. This increase was partially offset by declining sales of more mature products, such as the Express 2 centrifuge. Total international revenue represented 32% of the 2009 consolidated first quarter revenue versus 36% in the same period a year ago.

 

14


Table of Contents

Overall gross profit margin was 54% during the first quarter of 2009 and 2008. The gross profit margin of our IVD instruments was 42% and 52% during the first quarter of 2009 and 2008, respectively. As compared to the prior year period, the first quarter of 2009 gross margin was impacted by approximately $200,000 in unfavorable foreign currency translation, $155,000 in sales promotions, $120,000 for iChem VELOCITY-related costs and $175,000 in other costs. The gross margin of our IVD consumables and services was 61% and 56% for the first quarter of 2009 and 2008, respectively. The consumables and service gross margin improvement primarily resulted from economies of scale generated by our increasing volume of urine microscopy consumables, increased sales of spare parts to our international distributors and improved efficiencies in our domestic service business, partially offset by unfavorable foreign currency fluctuations on purchases of dry chemistry strips denominated in Japanese Yen. Our chemistry strip manufacturing operation continues to operate below capacity, but we expect to improve its utilization with increased demand for our proprietary urine chemistry test strips as a result of an increasing installed base our new iChem VELOCITY automated urine chemistry analyzers in the mid to high volume segment of the urinalysis market. In addition, we experienced gross profit margin improvement in our domestic instrument service as a result of economies of scale and cost containments. Gross profit margin for our sample processing segment decreased to 49% during the first quarter of 2009 from 51% during the first quarter of 2008 as a result of product mix with the new Express 4 drawing slightly lower margins than previous versions of the product.

Marketing and selling expenses totaled $3.9 million, or 18% of revenues, during the first quarter of 2009 as compared to $3.9 million, or 18% of revenues, during the first quarter of 2008. The increase in additional personnel and related costs of $195,000 and other expenses of $85,000 was offset by lower commissions and GPO fees of $52,000 and travel and show related expenses of $198,000. The increase in personnel and related costs is the result of our previous investments to enhance our sales and marketing support in order to meet the needs of our growing business. We expect to continue to invest in these areas to strengthen our global presence and support for the anticipated launches of our extensive product pipeline.

General and administrative expenses increased to $3.1 million or 15% of revenues in the first quarter of 2009 from $2.8 million and 13% of revenue during the first quarter of 2008. The increase was primarily attributable to stock compensation expenses of $280,000 and other expenses of approximately $100,000.

Research and development expenses increased to $2.8 million, or 13% of revenues in the first quarter of 2009 as compared to $2.6 million, or 12% of revenues in the first quarter of 2008. During the current quarter, the increase was primarily attributable to $74,000 in molecular diagnostics clinical development, $47,000 in prototype and research materials and $80,000 for legal and outside consultants as we continue to invest heavily in research and development for the continued development of our diagnostics product pipeline, including our NADiA platform and hematology analyzers.

Interest income significantly decreased during the first quarter of 2009 to $203,000 from $341,000 during the first quarter of 2008, as a result of the lower interest rate environment.

Income tax expense during the first quarter of 2009 amounted to 32% of pre-tax income as compared to 33% during the prior year quarter. We have deferred tax assets relating to tax loss carry forwards and research and development tax credits.

Off-Balance Sheet Arrangements

At March 31, 2009 and 2008, we did not have any relationships with unconsolidated entities or financial partnerships, such as entities often referred to as structured finance or special purpose entities, which would have been established for the purpose of facilitating off-balance sheet arrangements or other contractually narrow or limited purposes. As such, we are not exposed to any financing, liquidity, market or credit risk that could arise if we had engaged in such relationships.

Liquidity and Capital Resources

Our primary source of liquidity is cash from operations, which depends heavily on sales of our IVD instruments, consumables and service, as well as sales of sample processing instruments and supplies. At March 31, 2009, our cash and cash equivalents amounted to $26.7 million compared to $24.4 million at December 31, 2008.

Adverse macro economic forces have been impacting our selling markets and the credit markets of our customers. Although the impact thus far has been relatively mild, we continue to face the following challenges: deferrals of purchases due to decreases in capital budgets of our customers, delays in the purchasing cycle due to greater scrutiny of deals and increased internal competition for limited capital dollars, and a significant increase in requests for quotes for operating leases. The aforementioned factors may lead to a decrease in revenue, an increase of deferred revenue, or could lead to installment cash collections that will affect our liquidity and capital resources.

 

15


Table of Contents

Operating Cash Flows. Cash provided by operations for the three months ended March 31, 2009 improved to $4.1 million compared to cash provided by operations of $1.7 million during the prior year quarter. Our improvement includes non-cash items consisting of higher stock-based compensation expense of $370,000 and tax benefits from stock option exercises of $627,000. In addition, we experienced a $1.8 million reduction in accounts receivable, $1.8 million reduction in prepaid expenses and other current assets primarily due to a nonrecurring $1.5 million payment from IDEXX Labs, Inc. under the December 2008 manufacturing, supply and transition agreement. The sources of cash were partially offset by a $429,000 decrease in net income, an increase in inventories of $201,000, a $991,000 reduction in accounts payable and accrued expenses and a decrease of deferred taxes of $685,000 as compared to the prior quarter.

The number of days sales in accounts receivable increased to 73 days at the end of the first quarter compared to 62 days for the prior year quarter. The number of day’s sales in accounts receivables varies and extends due to extended payment terms for our international customers and an increased volume of extended payment terms for certain customers for our instrument sales.

Our cash flow has been favorably affected by tax credit carry forwards. As of December 31, 2008, we have federal and state tax credit carry forwards of $1.8 million and $2.1 million, respectively, net of valuation allowances. We continue to realize tax deductions from the exercise of certain stock options. During the year ended December 31, 2008, we realized tax deductions of approximately $1.9 million relating to this item.

Investing Activities. Cash provided by investing activities totaled $1.3 million during the first quarter of 2009, a $2.3 million increase over the prior year quarter primarily as a result of the sale of short term marketable securities in the amount of $2.2 million.

Financing Activities. Cash used in financing activities totaled $2.8 million during the first quarter, a $1.2 million decrease over the prior year quarter primarily as a result of the reduction in the repurchase of common stock amounting to $2.5 million partially offset by the decrease from the issuance of common stock of $608,000 and a reduction of tax deduction benefits from the exercise of stock options of $627,000 over the prior year’s first quarter.

We currently have a credit facility with a commercial bank consisting of a $6.5 million revolving line of credit for working capital and a $10.0 million line of credit for acquisitions and product opportunities. The credit facility has variable interest rates, which will change from time to time based on changes to either the LIBOR rate or the lender’s prime rate. As of March 31, 2009, there were no borrowings under the new credit facility. We are subject to certain financial and non-financial covenants under the credit facility with the bank and as of March 31, 2009, we were in compliance with these covenants.

In November 2007, we filed with the Securities and Exchange Commission a shelf registration statement on Form S-3, which allows us to sell up to $125 million in common stock, preferred stock or debt securities from time to time. In December 2007, the shelf registration statement was declared effective. As of March 31, 2009, no securities had been issued pursuant to this registration statement.

On March 3, 2008, the Company’s board of directors authorized a share repurchase and retirement plan of up to $15,000,000 of the Company’s common stock over a 12-month period. Under this plan the Company repurchased 492,068 shares of our common stock for $5,748,000. On July 25, 2008, the Company’s board of directors terminated the share repurchase and retirement plan.

On November 21, 2008, the Company’s board of directors authorized a share repurchase and retirement plan of up to $10,000,000 of the Company’s common stock over a 12-month period. During the three months ended March 31, 2009, the Company repurchased 250,800 shares of common stock for $2,500,000. Under this plan as of March 31, 2009, the Company had repurchased a cumulative total of 742,311 shares of common stock for approximately $8,660,000.

We believe that our current cash on hand, together with cash generated from operations and cash available under the credit facility with the bank will be sufficient to fund normal operations for the foreseeable future. However, additional funding may be required to fund expansion of our business. There is no assurance that such funding will be available, or if available, on terms acceptable to us.

Recent Accounting Pronouncements

In September 2006, the FASB issued SFAS No. 157, “Fair Value Measurements”, or “SFAS 157”. SFAS 157 establishes a framework for measuring fair value in accordance with generally accepted accounting principles, clarifies the definition of fair value within that framework and expands disclosures about fair value measurements. SFAS 157 applies whenever other standards require (or permit) assets or liabilities to be measured at fair value, except for the measurement of share-based payments. SFAS 157 was effective for the Company on January 1, 2008. However, since the issuance of SFAS No. 157, FASB has issued several FASB Staff

 

16


Table of Contents

Position (FSP) to clarify the application of FAS No. 157 “Fair Value Measurements”. On February 2008, the FASB released FASB Staff Position (FSP) SFAS No. 157-2, “Effective Date of FASB Statement No. 157”, which delayed the effective date of SFAS 157 for all nonfinancial assets and nonfinancial liabilities, except those that are recognized or disclosed at fair value in the financial statements on a recurring basis (at least annually). On October 2008, the FASB issued FASB Staff Position (FSP) SFAS No. 157-3, “Determining the Fair Value of a Financial Asset When the Market for That Asset Is Not Active”, which clarifies the application of Statement 157 in a market that is not active and provides guidance in key considerations in determining the fair value of a financial asset when the market for that financial asset is not active. FASB Staff Position applies to financial assets within the scope of accounting pronouncements that require or permit fair value measurements in accordance with FASB statement No. 157, “Fair Value Measurements”. On April 2009, the FASB issued FASB Staff Position (FSP) SFAS No. 157-4, “Determining the Fair Value When the Volume and Level of Activity for the Asset or Liability Have Significantly Decreased and Identifying Transactions That Are Not Orderly”, provides additional guidance for estimating fair value in accordance with FASB Statement No. 157, “Fair Value Measurements”, when the volume and level of activity for the asset or liability have significantly decreased. SFAS No. 157-4 also provides guidance on identifying circumstances that indicate a transaction is not orderly. FSP SFAS No. 157-4 is effective for interim and periods ending after June 15, 2009, and shall be applied prospectively. The adoption of SFAS 157 for financial assets and liabilities did not have a material impact on our consolidated financial statements other than the disclosures required by SFAS No. 107, “Disclosures about Fair Value of Financial Instruments” in our Interim Report on From 10-Q for the period ending March 31, 2009. The adoption of SFAS 157 for nonfinancial assets and nonfinancial liabilities, effective January 1, 2009, did not have a material impact on our consolidated financial statements.

On April 2009, the FASB issued FASB Staff Position (FSP) FAS 107-1, “Interim Disclosures about Fair Value of Financial Instruments”, which requires disclosures about fair value of financial instruments for interim reporting periods of publicly traded Companies as well as in annual financial statements. FSP FAS 107-1 also amends APB Opinion No. 28, “Interim Financial Reporting”, to require those disclosures in summarized financial information at interim reporting. FSP FAS 107-1 is effective for interim reporting periods ending after June 15, 2009, with early adoption permitted for periods ending after March 15, 2009. The Company will evaluate the potential impact of FSP FAS107-1 on these disclosures on a prospective basis.

In December 2007, the Financial Accounting Standards Board issued SFAS No. 141 (revised 2007), “Business Combinations”, which replaces SFAS No 141. The statement retains the purchase method of accounting for acquisitions, but requires a number of changes, including changes in the way assets and liabilities are recognized in the purchase accounting. It also changes the recognition of assets acquired and liabilities assumed arising from contingencies, requires the capitalization of in-process research and development at fair value, and requires the expensing of acquisition-related costs as incurred. SFAS No. 141R is effective for us beginning July 1, 2009 and will apply prospectively to business combinations completed on or after that date. On April 2009, the FASB issued FASB Staff Position (FSP) No. FAS 141(R)-1, “Accounting for Assets Acquired and Liabilities Assumed in a Business Combination That Arise from Contingencies”, which amends and clarifies FASB Statement No. 141 (R), “Business Combinations”. This FAS 141(R)-1 address issues raised by preparers, auditors, and members of the legal profession on initial recognition and measurement, subsequent measurement and accounting, and disclosure of assets and liabilities arising from contingencies in a business combination. FAS 141 (R)-1 is effective for assets or liabilities arising from contingencies in business combinations for which the acquisition date is on or after the beginning of the first reporting period beginning on or after December 15, 2008. The adoption of SFAS No. 141(R) did not have a material impact to the Company’s consolidated financial statements.

 

17


Table of Contents

In December 2007, the FASB issued SFAS No. 160, “Noncontrolling Interests in Consolidated Financial Statements,” an amendment of ARB 51, which changes the accounting and reporting for minority interests. Minority interests will be recharacterized as noncontrolling interests and will be reported as a component of equity separate from the parent’s equity, and purchases or sales of equity interests that do not result in a change in control will be accounted for as equity transactions. In addition, net income attributable to the noncontrolling interest will be included in consolidated net income on the face of the income statement and, upon a loss of control, the interest sold, as well as any interest retained, will be recorded at fair value with any gain or loss recognized in earnings. SFAS No. 160 is effective beginning December 15, 2008 and will apply prospectively, except for the presentation and disclosure requirements. The adoption of SFAS No. 160 did not have a material impact to the Company’s consolidated financial statements.

On January 2009, the FASB issued FASB Staff Position (FSP) No. EITF 99-20-1, “Amendments to the Impairment Guidance of EITF Issue No. 99-20”, which amends the impairment guidance in EITF issue No. 99-20, “Recognition of Interest Income and Impairment on Purchased Beneficial Interest and Beneficial Interests That Continue to Be Held by a Transferor in Securitized Financial Assets,” to achieve more consistent determination of whether an other-than-temporary impairment has occurred. FSP EITF 99-20-1 retains and emphasizes the other-than-temporary impairment assessment guidance and required disclosures in FASB Statement No. 115, “Accounting for certain Investments in Debt and Equity Securities”. FSP EITF 99-20-1 is effective for interim and annual reporting periods ending after December 15, 2008, and shall be applied prospectively. Currently, there is no impact of the adoption of FSP EITF 99-20-1 on the Company’s consolidated financial position, results of operations and cash flows.

On April 2009, the FASB issued FASB Staff Position (FSP) No. FAS 115-2 and FAS 124-2, “Recognition and Presentation of Other-Than-Temporary Impairments”, to determine whether the holder of an investment in a debt or equity security for which changes in fair value are not regularly recognized in earnings (such as securities classified as held-to-maturity or available-for-sale) should recognize a loss in earnings when the investment is impaired. FSP No. FAS 115-2 and FAS 124-2 improves the presentation and disclosure of other-than-temporary impairments on debt and equity securities in the financial statements. The effective date for interim and annual reporting periods ending after June 15, 2009, with early adoption permitted for periods ending after March 15, 2009. Earlier adoption for periods ending before March 15, 2009, is not permitted. The Company does not believe the adoption of FSP No. FAS 115-2 and FAS 124-2 will have a material impact to the Company’s consolidated financial statements.

 

Item 3. Quantitative and Qualitative Disclosures About Market Risk

Market Risk

Our business is exposed to various market risks, including changes in interest rates and foreign currency exchange rates. Market risk is the potential loss arising from adverse changes in market rates and prices, such as interest rates and foreign currency exchange rates. We do not invest in derivatives, foreign currency forward contracts or other financial instruments for trading or speculative purposes. We had no debt at March 31, 2009, thus were not subject to market risk for changes in interest rates on debt obligations. We are subject to market risk for changes in interest rates on our short-term investment portfolio. We invest our excess cash in certificates of deposit and other short-term investments, and the market value of these investments fluctuates based on changes in interest rates.

Foreign Currencies

We conduct business in certain foreign markets, primarily in the European Union and Asia. Our primary exposure to foreign currency risk relates to investments in foreign subsidiaries that transact business in a functional currency other than the U.S. Dollar, primarily the Euro. We are subject to certain foreign currency risks in the importation of goods from Japan and as a result of commercial operations in Europe and Asia. Our purchases from a major Japanese IVD supplier are denominated in Japanese Yen. These components represent a significant portion of our material costs. All of our sales are denominated in U.S. Dollars with the exception of France, where sales are denominated in Euros. Fluctuations in the U.S. Dollar exchange rate for Japanese Yen and Euros could result in increased costs for our key components and increased costs for commercial operations in Europe.

 

18


Table of Contents

To mitigate the potential impact of adverse fluctuations in the U.S. Dollar exchange rate for these currencies, we periodically purchase foreign currency forward contracts. During the year ended December 31, 2008, we entered into such contracts for Euros and Japanese Yen totaling $404,000 and $7.6 million, respectively. As of December 31, 2008, however, we did not have any remaining foreign currency forward contracts outstanding in Japanese Yen or Euros, and we did not enter into any such foreign currency forward contracts during the three months ended March 31, 2009.

 

Item 4. Controls and Procedures

Evaluation of Disclosure Controls and Procedures

We maintain disclosure controls and procedures, as defined by paragraph (e) of Rules 13a-15(f) or 15d-15(f) under the Securities Exchange Act of 1934, as amended, designed to ensure that we are able to collect the information we are required to disclose in the reports we file with the SEC and to approve, summarize and disclose this information within the time periods specified in the rules of the SEC. Our Chief Executive Officer and Chief Financial Officer are responsible for establishing and maintaining these procedures, and, as required by the rules of the SEC, evaluate their effectiveness. Our Chief Executive Officer and Chief Financial Officer evaluated the effectiveness of our disclosure controls and procedures as of March 31, 2009, the end of the period covered by this report, and based upon that evaluation, the Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures are effective.

Changes in Internal Controls over Financial Reporting

There was no change in our internal control over financial reporting during the quarter ended March 31, 2009 that materially affected, or is reasonable likely to materially affect, our internal control over financial reporting.

 

19


Table of Contents

PART II: OTHER INFORMATION

 

Item 1A. Risk Factors

This Quarterly Report on Form 10-Q contains forward-looking statements, which are subject to a variety of risks and uncertainties. Other actual results could differ materially from those anticipated in those forward-looking statements as a result of various factors, including those set forth in the risk factors relating to our business and common stock contained in Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2008. There have been no material changes to such risk factors during the three months ended March 31, 2009.

 

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds

On November 21, 2008, our board of directors authorized a share repurchase and retirement plan of up to $10,000,000 of our common stock over a 12-month period. During the three months ended March 31, 2009, we repurchased the following 250,800 shares of common stock at an average price per share of approximately $9.93, for aggregate proceeds of approximately $2,500,000. The Company repurchased all shares during January 2009. As of March 31, 2009, under the November 2008 repurchase and retirement plan, we have repurchased a total of 742,311 shares of common stock for approximately $8,660,000, and may repurchase an additional $1,340,000 of our common stock before expiration of the plan in November 2009.

 

Item 6. Exhibits

 

Exhibit
Number

  

Description

   Reference
Document
31.1    Certification Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 by Chief Executive Officer    *
31.2    Certification Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 by Chief Financial Officer    *
32.1    Certification Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 by Chief Executive Officer    *
32.2    Certification Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 by Chief Financial Officer    *

 

* File herewith

 

20


Table of Contents

SIGNATURES

Pursuant to the requirements 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.

 

Date: May 4, 2009   IRIS INTERNATIONAL, INC.
  By:  

/s/ César M. García

    César M. García
    President and Chief Executive Officer
  By:  

/s/ Peter Donato

    Peter Donato
    Chief Financial Officer
    (Principal Financial Officer and Principal Accounting Officer)

 

21