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8-K - FORM 8-K - IRIS INTERNATIONAL INCc24123e8vk.htm
Exhibit 99.1
     
(IRIS LOGO)   NEWS RELEASE
CONTACTS:
Amin Khalifa, Chief Financial Officer
IRIS International, Inc.
818-527-7323
-or-
Lynn Pieper, Westwicke Partners
415-202-5678
lynn.pieper@westwicke.com
IRIS INTERNATIONAL ANNOUNCES THIRD QUARTER 2011
REVENUE AND FINANCIAL RESULTS
   
Record revenue of $28.1 million; 9% growth over Q3 2010
 
   
Gross margin of 50% in Q3 2011; Excluding Arista, gross margin of 52%
 
   
Restructured Personalized Medicine Division by downsizing and consolidating Arista Molecular’s operations into Iris Molecular Diagnostics
 
   
GAAP net loss per share of ($0.24); Non-GAAP diluted EPS was $0.05 per share excluding $7.6 million of one-time restructuring charges and write-downs of related assets
CHATSWORTH, Calif., November 3, 2011 — IRIS International, Inc. (NASDAQ: IRIS), a leading manufacturer of automated in-vitro diagnostics systems and consumables, and a provider of high value personalized diagnostics testing services through its CLIA certified molecular diagnostics laboratory, today announced financial results for the third quarter ended September 30, 2011.
Third Quarter 2011 Performance Highlights
   
Achieved revenue of $28.1 million for the third quarter ended September 30, 2011, representing 9% growth over Q3 2010.
   
Increased Iris Diagnostics Division (IDD) sales by 10% to $24.7 million as compared to $22.4 million in the prior year period.
   
Realized gross margin of 50% for the third quarter 2011 compared to 51% in the prior year period. Excluding the impact from Arista in both periods, consolidated gross margin was 52%.
   
Received 510(k) clearance from the FDA in September 2011 and CE Mark approval in October 2011 for its NADiA® ProsVue™ prognostic prostate cancer test.
   
NADiA ProsVue slope is indicated for use as a prognostic marker in conjunction with clinical evaluation as an aid in identifying those patients at reduced risk for recurrence of prostate cancer for the eight year period following prostatectomy. A ProsVue slope of less than 2.0 pg/ml per month in the first year following radical prostatectomy was highly associated with no evidence of disease over the long term follow up.
   
NADiA ProsVue is expected to reduce unnecessary treatment of certain post-prostatectomy men thus reducing the morbidity and costs associated with adjuvant treatment such as radiation therapy.

 

 


 

   
Completed restructuring of its Personalized Medicine division by downsizing and consolidating Arista Molecular’s operations into Iris Molecular Diagnostics. Consolidation enables significant cost reductions and enhanced profitability.
   
One-time restructuring expense of $1.8 million and write-downs of related assets of $5.8 million taken in 3Q 2011.
   
Arista has retained all licenses and high-complexity CLIA laboratory capabilities, as well as the necessary personnel to perform NADiA ProsVue during the early stages of product introduction. Non-proprietary testing services have been discontinued.
   
Reported net loss for Q3 2011 of $4.3 million, versus net income of $0.9 million in Q3 2010. Net loss per share was ($0.24) in Q3 2011 versus diluted EPS of $0.05 in Q3 2010. Excluding charges related to the restructuring of Arista that are one time in nature, non-GAAP net income for Q3 2011 was $935,000 and non-GAAP diluted EPS was $0.05 per share, in spite of an approximate $0.7 million increase in R&D spending to fund new platforms.
“We are pleased to announce our third quarter results with record revenue reflecting strong growth in our diagnostics business. The increase in instrument sales was primarily driven by strong international demand, with consumable sales showing double-digit growth driven by our large installed base,” stated César M. García, Chairman, President and Chief Executive Officer of IRIS International.
“Additionally in the quarter, we restructured the Personalized Medicine business which we believe will result in significant expense reductions and enhanced profitability in future periods. I am particularly pleased that we also announced the FDA clearance and CE Mark approval of NADiA ProsVue. We look forward to our initial launch in 2012 and long-term commercial success of ProsVue,” Mr. García added.
“We continue to make significant progress on our 3GEMS urinalysis and hematology development programs. In October, our 3GEMS Hematology program achieved another milestone by demonstrating the integration of the complete blood count module with the imaging channel, triggering our second milestone payment from our Japanese partner. In addition, our new automated FISH platform product is on schedule to be launched in the first quarter of 2012 and is expected to reinvigorate growth in our Iris Sample Processing Division. We are achieving significant milestones in our development programs, which will further expand our product portfolio. These efforts coupled with our cost reduction initiatives are expected to drive higher revenue and earnings growth starting in 2012.”
Third Quarter 2011 Financial Results
   
Consolidated revenues of $28.1 million for Q3 2011 represented growth of 9% versus Q3 2010 consolidated revenues of $25.7 million. For the third quarter ended September 30, 2011, IDD sales increased 10% year over year to $24.7 million as compared to $22.4 million in the prior year period, driven by strong growth in international instrument sales, particularly in the Asia Pacific region.
   
IDD instrument sales of $7.1 million represented 5% growth over Q3 2010, driven primarily by strong international sales in the quarter. IDD consumables and service revenue of $17.5 million in Q3 2011 represented 13% growth over Q3 2010 and accounted for 62% of sales in the quarter driven primarily by our larger domestic and international installed base.
   
Revenue at the Iris Sample Processing Division increased 1% to $3.4 million for Q3 2011, when compared with revenue of $3.3 million in Q3 2010.
Consolidated gross margin was 50% for the third quarter 2011 versus 51% reported for the prior period. Excluding the impact from the Arista segment, gross margin was 52% in both periods. IDD instrument gross margin improved to 37% for Q3 2011 versus 35% in Q3 2010. The increase was primarily driven by efficiency improvements related to higher production volume of iChemVELOCITY and an integrated iRICELL workstation, slightly offset by regional mix with strong international instrument sales in Q3 2011. IDD consumables and service gross margin was 57% for Q3 2011, as compared to 59% in the year ago period, the decrease primarily resulting from higher costs of Japanese sourced chemistry strips due to the appreciation of the Yen versus a year ago and an increase in service personnel to support our increasing installed base of instruments. Gross margin for the Sample Processing segment was 58% for Q3 2011 versus 54% in the prior year quarter. The increase was primarily due to favorable product mix.

 

 


 

The net loss for Q3 2011 was $4.3 million, versus net income of $0.9 million in Q3 2010. Excluding one-time impairment and restructuring charges in Q3 2011, non-GAAP net income was $935,000. The effective tax rate for the third quarter was 42% compared with 41% for the third quarter of 2010.
The Company’s balance sheet remains strong with cash of $19 million and no debt at September 30, 2011.
2011 Company Outlook
The company is narrowing the full year 2011 revenue guidance range to $117 — $120 million from $117 - $123 million, representing 9-11% growth over 2010. The company is maintaining non-GAAP EPS guidance $0.21 — $0.23, which excludes one-time restructuring and asset impairment charges taken in the third quarter of 2011, but reflects cost reductions in the fourth quarter as a result of the restructuring efforts.
Conference Call
IRIS International will host a conference call today at 4:30 p.m. Eastern time, 1:30 p.m. Pacific time. To participate, dial 1-877-870-9220 approximately 10 minutes before the conference call is scheduled to begin. Hold for the operator and reference the IRIS International conference call. International callers should dial 973-638-3437. The conference call may also be accessed by means of a live audio webcast on our website at http://proiris.com. The conference web cast will be archived and available for replay for 30 days from the date of the broadcast.
About IRIS International, Inc.
IRIS International, Inc. is a leading global in vitro diagnostics company focused on products that analyze particles and living cell forms and structures, or morphology of a variety of body fluids. The Company’s products leverage its strengths in flow imaging technology, particle recognition and automation to bring efficiency to hospital and commercial laboratories. The initial applications for its technology have been in the urinalysis market and the Company is the leading worldwide provider of automated urine microscopy and chemistry systems, with an installed base of more than 3,400 systems in more than 50 countries. The Company is expanding its core imaging and morphology expertise into related markets, including applications in hematology and body fluids. In addition, the Company’s personalized medicine group has a high complexity CLIA-certified laboratory for the further development and commercialization of the Company’s NADiA ultra-sensitive nucleic acid detection immunoassay platform, with applications in oncology and infectious disease. For more information, please visit www.proiris.com.
Safe Harbor Provision
This press release contains forward-looking statements made in reliance upon the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, the Company’s views on future financial performance, market growth, capital requirements, regulatory developments, new product introductions and acquisitions, and are generally identified by phrases such as “thinks,” “anticipates,” “believes,” “estimates,” “expects,” “intends,” ,“plans,” and similar words. Forward-looking statements are not guarantees of future performance and are inherently subject to uncertainties and other factors which could cause actual results to differ materially from the forward-looking statement. These statements are based upon, among other things, assumptions made by, and information currently available to, management, including management’s own knowledge and assessment of the Company’s industry, R&D initiatives, competition and capital requirements. Other factors and uncertainties that could affect the Company’s forward-looking statements include, among other things, the following: identification of feasible new product initiatives, management of R&D efforts and the resulting successful development of new products and product platforms; obtaining regulatory approvals for new and enhanced products; acceptance by customers of the Company’s products; integration of acquired businesses; substantial expansion of international sales; reliance on key suppliers; the potential need for changes in long-term strategy in response to future developments; future advances in diagnostic testing methods and procedures; potential changes in government regulations and healthcare policies, both of which could adversely affect the economics of the diagnostic testing procedures automated by the Company’s products; rapid technological change in the microelectronics and software industries; and competitive factors, including pricing pressures and the introduction by others of new products with similar or better functionality than our products. These and other risks are more fully described in the Company’s filings with the Securities and Exchange Commission, including the Company’s most recently filed Annual Report on Form 10-K and Quarterly Report on Form 10-Q, which should be read in conjunction herewith for a further discussion of important factors that could cause actual results to differ materially from those in the forward-looking statements. The financial results presented in this press release are subject to change pending the filing of the Company’s Quarterly Report on Form 10-Q for the period ended September 30, 2011. The Company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

 

 


 

Non-GAAP Financial Measures
“GAAP” refers to financial information presented in accordance with generally accepted accounting principles in the United States.
To supplement the condensed consolidated financial statements and discussion presented on a GAAP basis, this press release includes non-GAAP financial measures with respect to the three month and nine month periods ended September 30, 2011. Management uses non-GAAP financial measures because it believes the appropriate analysis of our profitability cannot be effectively considered while incorporating the effect of unusual items and charges that have not been experienced consistently in prior periods. Also, management believes these non-GAAP measures facilitate the comparison of our historical results to our competitors. The Company is reporting herein the following non-GAAP financial measures: “adjusted net income,” and “adjusted diluted earnings per share.” These non-GAAP financial measures are not in accordance with or an alternative to GAAP.
Adjusted net income excludes items which are considered unusual and the related incremental tax effect of these items. Adjusted diluted earnings per share excludes the effect of the same items described above from diluted earnings per share. Reconciliations of net income (loss), the GAAP measure most directly comparable to adjusted net income, and diluted earnings (loss) per share, the GAAP measure most directly comparable to adjusted diluted earnings per share, are provided on the attached schedule.
The presentation of historical non-GAAP financial measures is not meant to be considered in isolation from or as a substitute for results prepared in accordance with GAAP. We use these non-GAAP measures to supplement net earnings and other corresponding measures on a basis prepared in conformance with GAAP. These non-GAAP financial measures reflect additional ways of viewing aspects of our operations that when viewed with our GAAP results provide a more complete understanding of factors and trends affecting our business. However, investors should understand that the excluded items are actual expenses that may impact the cash available to us for other uses. We strongly encourage investors to consider both net earnings (loss) and cash flows determined under GAAP as compared to the non-GAAP measures presented and to perform their own analysis, as appropriate.
Reconciling Items to Non-GAAP Financial Measures
The non-GAAP measures described above exclude the following items:
  a)  
Arista and IDD restructuring related costs — For the three and nine month periods ended September 30, 2011, we recorded restructuring related expenses of $1.8 million.
  b)  
Arista impairment charge — For the three and nine month periods ended September 30, 2011, we recorded an impairment charge of $5.8 million related to the Arista restructuring.

 

 


 

(TABLES FOLLOW)
IRIS INTERNATIONAL, INC.
CONSOLIDATED BALANCE SHEETS

(in thousands)
                 
    September 30     December 31,  
    2011     2010  
    (unaudited)        
Assets
               
Current assets:
               
Cash and cash equivalents
  $ 18,858     $ 25,531  
Accounts receivable, net
    23,264       20,733  
Inventories
    13,252       10,310  
Prepaid expenses and other current assets
    1,487       1,661  
Investment in sales-type leases, current portion
    3,999       3,578  
Deferred tax asset
    4,395       3,135  
 
           
Total current assets
    65,255       64,948  
 
           
 
               
Property and equipment, net
    13,871       12,035  
Goodwill
    2,451       3,957  
Intangible assets, net
    6,097       9,345  
Software development costs, net
    2,407       2,637  
Deferred tax asset
    2,495       2,615  
Investment in sales-type leases, non-current portion
    11,268       10,002  
Other assets
    1,262       1,070  
 
           
Total assets
  $ 105,106     $ 106,609  
 
           
 
               
Liabilities and Stockholders’ Equity
               
Current liabilities:
               
Accounts payable
  $ 5,764     $ 5,795  
Accrued expenses
    8,476       7,513  
Deferred service contract revenue, current portion
    3,849       3,205  
 
           
Total current liabilities
    18,089       16,513  
Deferred service contract revenue, non-current portion
    47       71  
Other long term liabilities
    55       1,374  
 
           
Total liabilities
    18,191       17,958  
 
               
Commitments and contingencies
               
 
               
Stockholders’ equity:
               
Common stock
    179       178  
Preferred Stock
           
Additional paid-in capital
    92,354       89,703  
Other comprehensive income
    (156 )     140  
Accumulated deficit
    (5,462 )     (1,370 )
 
           
Total stockholders’ equity
    86,915       88,651  
 
           
Total liabilities and stockholders’ equity
  $ 105,106     $ 106,609  
 
           
(More)

 

 


 

IRIS INTERNATIONAL, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS

(unaudited — in thousands, except per share data)
                                 
    For the three months     For the nine months  
    ended September 30,     ended September 30,  
    2011     2010     2011     2010  
Revenues
                               
IDD instruments
  $ 7,147     $ 6,806     $ 22,772     $ 22,107  
IDD consumables and service
    17,545       15,558       51,577       45,274  
Sample processing instruments and supplies
    3,358       3,335       10,638       10,986  
Personalized medicine
    46       27       213       27  
 
                       
Total revenues
    28,096       25,726       85,200       78,394  
 
                       
 
                               
Cost of Goods Sold
                               
IDD instruments
    4,474       4,447       13,836       14,194  
IDD consumable and service
    7,492       6,425       22,060       18,168  
Sample processing instruments and supplies
    1,410       1,521       4,761       4,950  
Personalized medicine
    572       174       1,636       174  
 
                       
Total cost of goods sold
    13,948       12,567       42,293       37,486  
 
                       
 
                               
Gross profit
    14,148       13,159       42,907       40,908  
 
                       
 
                               
Marketing and selling
    5,635       4,956       17,590       14,152  
General and administrative
    4,220       4,202       14,838       12,562  
Research and development, net
    4,275       3,605       12,414       11,138  
Impairment of assets
    5,829             5,829        
Restructuring expenses
    1,770             1,770        
Gain on revaluation of contingent consideration
                (1,225 )      
 
                       
Total operating expenses
    21,729       12,763       51,216       37,852  
 
                       
 
                               
Operating income (loss)
    (7,581 )     396       (8,309 )     3,056  
 
                               
Other income (expense):
                               
Interest income
    278       328       826       844  
Interest expense
    (2 )     (2 )     (8 )     (7 )
Other income (expense)
    (16 )     856       397       183  
 
                       
Income before provision for income taxes
    (7,321 )     1,578       (7,094 )     4,076  
 
                               
Provision for income taxes
    (3,051 )     654       (3,003 )     1,486  
 
                       
 
                               
Net income (loss)
  $ (4,270 )   $ 924     $ (4,091 )   $ 2,590  
 
                       
 
                               
Net income (loss) per share — basic
  $ (0.24 )   $ 0.05     $ (0.23 )   $ 0.14  
 
                       
 
                               
Net income (loss) per share — diluted
  $ (0.24 )   $ 0.05     $ (0.23 )   $ 0.14  
 
                       
 
                               
Weighted average shares outstanding — basic
    17,845       17,978       17,793       17,947  
 
                       
 
                               
Weighted average shares outstanding — diluted
    17,845       18,044       17,793       18,056  
 
                       
(More)

 

 


 

IRIS INTERNATIONAL, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS

(unaudited — in thousands)
                 
    For the nine months  
    ended September 30,  
    2011     2010  
Cash flows from operating activities:
               
Net income (loss)
  $ (4,091 )   $ 2,590  
Adjustments to reconcile net income to net cash provided by operating activities:
               
Loss on disposal of fixed assets
    21       5  
Gain on foreign currency remeasurement
    (385 )     (105 )
Gain on revaluation of contingent consideration
    (1,225 )      
Deferred taxes
    (1,419 )     48  
Tax benefit from stock option exercises
    (66 )     (48 )
Depreciation and amortization
    4,027       3,084  
Stock based compensation
    3,103       3,193  
Impairment of assets
    5,829        
Changes in operating assets and liabilities:
               
Accounts receivable
    (2,515 )     (736 )
Inventories
    (2,902 )     (1,469 )
Prepaid expenses and other current assets
    (16 )     (725 )
Investment in sales-type leases
    (1,677 )     (1,963 )
Accounts payable
    60       280  
Accrued expenses
    879       1,737  
Deferred service contract revenue
    639       845  
Other liabilities
    (97 )      
 
           
 
               
Net cash provided by operating activities
    165       6,736  
 
           
 
               
Cash flows from investing activities:
               
Purchase of assets from European distributor
          (660 )
Acquisition of business
          (4,630 )
Refund on acquisition of business
    46        
Acquisition of property and equipment
    (6,361 )     (2,029 )
Software development costs capitalized
    (419 )     (554 )
 
           
 
               
Net cash used in investing activities
    (6,734 )     (7,873 )
 
           
 
               
Cash flows from financing activities:
               
Issuance of common stock for cash
    71       31  
Settlement on restricted stock tax withholding
    (243 )     (239 )
Repurchase of common stock
          (1,551 )
Tax benefit from stock option exercises
    66       48  
 
           
 
               
Net cash used in financing activities
    (106 )     (1,711 )
 
           
 
               
Effect of exchange rate changes on cash and cash equivalents
    2       (295 )
 
           
 
               
Net decrease in cash and cash equivalents
    (6,673 )     (3,143 )
Cash and cash equivalents at beginning of period
    25,531       34,253  
 
           
 
               
Cash and cash equivalents at end of period
  $ 18,858     $ 31,110  
 
           
 
               
Supplemental schedule of non-cash financing activities:
               
During the nine months ended September 30, 2011, the Company disposed of property and equipment with a cost and accumulated depreciation of $498 and $477, respectively.
               
Supplemental disclosure of cash flow information:
               
Cash paid for income taxes
  $ 1,231     $ 2,066  
Cash paid for interest
  $ 8     $ 7  

 

 


 

IRIS INTERNATIONAL, INC.
RECONCILIATION OF GAAP NET LOSS AND NET LOSS PER SHARE TO ADJUSTED
NET INCOME AND ADJUSTED DILUTED EARNINGS PER SHARE

(unaudited — in thousands, except per share data)
                                                 
    For the three months     For the nine months  
    ended September 30, 2011     ended September 30, 2011  
    Pretax     After tax     Per diluted     Pretax     After tax     Per diluted  
    amount     amount(1)(2)     share     amount     amount     share  
 
                                               
GAAP net loss & net loss per share
  $ (7,321 )   $ (4,270 )   $ (0.24 )   $ (7,094 )   $ (4,091 )   $ (0.23 )
 
                                               
Reconciling items:
                                               
 
                                               
Restructuring expenses
    1,770       1,080       0.06       1,770       1,080       0.06  
 
                                               
Impairment charge (excluding Goodwill)
    4,369       2,665       0.15       4,369       2,665       0.15  
 
                                               
Goodwill impairment (1)
    1,460       1,460       0.08       1,460       1,460       0.08  
 
                                   
Adjusted net income & diluted EPS (3)
  $ 278     $ 935     $ 0.05     $ 505     $ 1,114     $ 0.06  
 
                                   
     
(1)  
Goodwill is not tax affected
 
(2)  
Reconciling items taxed at statutory rate of 39%
 
(3)  
Amounts may not foot due to rounding.
See accompanying Non-GAAP Financial Measures section for description of Non-GAAP adjustments.
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